Podcasts about velentium

Dr. Shalabh Gupta, founder and CEO of Unicycive Therapeutics, shares his inspiring journey from practicing medicine to leading groundbreaking innovations in kidney disease treatment. Dr. Gupta discusses his comprehensive framework for identifying and developing medical solutions, his vision for Unicycive's future, and the importance of focus and execution in medical startups. He reveals the challenges and triumphs of bringing life-changing products to market and offers profound advice for new entrepreneurs in the industry.   Guest links: https://unicycive.com/  Charity supported: Feeding America Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 056 - Dr. Shalabh Gupta [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I am so excited to introduce you to my guest, Dr. Shalabh Gupta. Dr. Gupta is the founder and CEO of Unicycive Therapeutics. He is a visionary in healthcare, leading groundbreaking efforts to design innovative therapies and reimagine how we approach unmet medical needs. His work goes beyond the lab as he's driving a healthcare revolution by developing innovative therapies addressing critical gaps in treatment. His perspective combines decades of experience and expertise in drug design with a deep commitment to equity in health care. Well, welcome to the show, Shalabh. I'm so excited that you're here with me today. [00:01:35] Dr. Shalabh Gupta: Thank you. Thank you for hosting me. [00:01:36] Lindsey Dinneen: Of course. I'd love if you wouldn't mind just telling us a little bit about yourself, your background, and what led you to MedTech. [00:01:45] Dr. Shalabh Gupta: By way of background, I'm a physician, trained, practiced, did my medical training in internal medicine, residency in physical medicine and rehab, research fellowship in cardiac and pulmonary rehabilitation, board certified physician, practice in New York at NYU hospital, NYU Medical Center. This is where I did my medical training for roughly decade after finishing medical school. I also have a graduate degree in finance management from NYU. While I was doing my residency training, I realized that I wanted to find a way to have a broader impact on society as well as what we were working on in learning medicine. So, I started my career working initially with a biotechnology company at the time to help them get their drug with FDA through a regulatory approval process. The beginning of the process is called IND following a investigation new drug application, IND application. I actually visited FDA on their behalf, met with FDA back in the time when everything used to be in person. Built from there onward, joined Wall Street from working as a stock analyst. So I covered biotech companies as a stock analyst, and the weekend and holidays that were available, I worked to continue to practice the medicine at NYU as an attending physician, and then joined another bank and covered pharmaceutical stocks and worked covering six of the largest pharma companies that include Pfizer, Merck, Viacom, Selling Power, Eli Lilly, Bristol Myers Squibb. From there, I moved to California. I worked for Genentech in corporate strategy. Genentech, at the time, and continues to be, one of the largest biotechnology companies. And from working at Genentech, I got my inspiration to start my own companies. So I founded two companies prior to finding starting Unicycive. All my companies are focused on aesthetic therapeutic area. Unicycive is focused on nephrology, treatment of kidney diseases, and we have two drugs in development. We have a lead drug that is pending approval from the US FDA in June of 2025 this year. And the second, I guess, finish phase 1 clinical trial in the UK. And we are in discussion with the agency to proceed with the next stage of clinical trial in the US. So that's a quick background. [00:04:14] Lindsey Dinneen: Wow. That's incredible. Thank you for sharing your story. Yeah. So let's talk about your company now. You've become CEO of this company. You're developing these products that are going to change lives. What first made you realize that there was a gap that needed to be filled in the market for this? And then, what prompted you to go, "You know what? Hey, I think I can have the solution for this or I can have the answer to this." [00:04:38] Dr. Shalabh Gupta: The first question that you ask, understanding the unmet need in medicine, there are a lot of problems that you can address. So, to give you a framework, if I am thinking about a problem, I want to understand if a couple of things, and in order of priorities, these are: can I find a solution that with my resources-- resources is time, energy, and money-- can I create a product that will truly make it to the market? Number two is that I also feel that one can get very blindsided that "I have a solution," but not understand what other solutions exist in the market. So understanding the competitive landscape. If I create this drug, this device, this product, and it is going to take three to four years in the market to come to the market-- which, by the way, in medical word is a still very fast track because it takes much longer-- what will the competitive landscape look like for 5 years down the road? So that's the second part. And third is that what is the solution that I'm developing? Is it unique in terms of having a novel, either as a drug device or drug device combination, or as a patented drug, patented device, because in our industry, it's not really possible to scale up something until unless you have an IP or intellectual property protection. And then from there onward, the last thing is also, who's going to fund me, how I think about funding, not for next six months a year, but also a continuum of the product development. If I think about all these 4-5 problems, then you start to narrow it down. There are some problems that are very much worthy of exploration. For example, treatment of Alzheimer's, we all know it's a big unmet need, we all know there's a big market opportunity. But I realized that was something we couldn't do it with the products or the development candidates that I had seen. So, being able to define where is the end point and goal. Being able to understand, can I make an impact? And when I say I, I speak for myself, but each one of us, I always remind entrepreneurs, we each one of us have our own deck of cards. We have to play with our cards, we can't compare ourselves with somebody else, or we can compare some other cases study. So understanding more about what is so unique that I can bring to table that can I make a difference and then making a business around this where the thesis lies. Once you identify that, then there's a question about continuing to execute and keep changing your plan as you go along. [00:07:11] Lindsey Dinneen: Yeah, absolutely. Well, I love your framework for thinking through all of those things. And so of course you use that when you thought, "Hey, here's this issue. I could potentially have a solution," and you went through this process. And then can you tell us about your innovation now and how that is helping and how you expect it to help change all these wonderful lives? [00:07:33] Dr. Shalabh Gupta: So, so for treatment of kidney diseases, first of all, it has been one area of development that has not had that much of innovation. And, and I think that is where the initial part of the thesis was that focusing on nephrology of kidney diseases is not same as developing a drug for cancer treatment. Cancer treatment changes every six months a year. The standard of care continues to evolve. Is there an unmet need in cancer treatment? A hundred percent, but the part is that the pace of innovation is very rapid. Is it same in nephrology? It's getting there, but it's still the development of a new products in nephrology still is not at the same pace. So I thought there was something we could make a difference by a small company. The drug that I acquired from another company was a drug that had finished a clinical trial. So it had shown that the drug is safe. It had also shown some signal of it working in healthy volunteers. That's a phase one trial. And the innovation came from a car battery company that had figured out how to make a big, large size pill to make it smaller. And sometimes greatest innovation, greatest insight come from the fact that when I talk to the kidney doctors, the physicians who take care of these patients there with the treatment of kidney diseases, they said the problem for these patients are the patients have to take 12 to 15 pills per day. And this innovation allowed us to be able to make that number of pills go down from 13 to 12 or 15 to three pills per day, one pill with each meal. And then the regulatory pathway became a bit more clear that if I can show that our drug is similar to the drug that was in the market, maybe there was an opportunity to go through expedited pathway, which is what we did. And I acquired the drug in 2018, went to FDA right after acquiring the drug to expedite the pathway again, thinking about de risking the development pathway. And as I mentioned in 2025, we are expecting the approval. So that is the process about it. And that's the story behind the lead drug. [00:09:51] Lindsey Dinneen: Great. Excellent. So that is really exciting. And as you continue to go forward with this company and the innovations that you're creating, what is your ultimate goal or dream that you're really striving for? [00:10:06] Dr. Shalabh Gupta: So, the focus for Unicycive is building new novel treatment for kidney diseases. Our lead drug is expecting approval in June 2025. But we have a second drug in development, and we continue to think about what will be something that we as a small company can bring to market. There are other areas of unmet need in kidney treatment. But instead of doing too many things at the same time, we continue to think, "How do we grow our company? What will be the vision for the company three years down the road, five years down the road?" And what we want to continue doing is to develop the drug candidates, advance them. Right now, after the first drug we get through approval, it will be the second drug. There is a thought process behind it. One of the biggest challenges that I've seen for smaller companies and startups is that they end up in doing too many things at the same time, which is difficult to do, even for big companies. You know, big companies, they have a one product that is a marquee product, they launch that and then they develop other things. So, being able to stay focused is also key because you can have a lot of energy, you can have a lot of ideas, but you have to focus on which one you can do first. [00:11:22] Lindsey Dinneen: Yeah, that is so true. It's such great advice, a good reminder. Yes, focus is so important. You know, honestly, that's probably one of the tricky things that startups in this particular field might struggle with is that focus. So I'm wondering what kind of advice do you have for say a brand new entrepreneur in the industry who has these great ideas, but you know, maybe has so many that they're a little too scattered. [00:11:52] Dr. Shalabh Gupta: Right. So, I think you may start with 10 ideas but the framework I gave you that: can this idea in this given timeframe with my resources and the funds that I can raise, can it make a difference? So you start to narrow it down. You start with a big funnel, narrow it down. And then maybe you have two or three ideas. Instead of thinking to yourself that "No, I'm not going to tell my idea to anyone because somebody else can take it away," find people who will be willing to pressure test those ideas. Then you will have identified something, maybe one Idea that is worth the pursuit. So then you focus on that. So that's one part of how to triage it because we all have ideas, but those ideas may not be worth developing once you go and talk to the marketplace. And marketplace is your investors, the physicians, and the patients. I keep saying about these three stakeholders, because if physicians cannot prescribe what you are developing, then it's of no use. If patients don't necessarily benefit, then it's of no use. And if you cannot get insurance companies a reimbursement for that means the product will never get here. So it's a process, but nobody can come up with an idea. And there is no great idea. There are ideas that you have to, and then once you find that one idea that resonates with all the stakeholders, physicians are excited about it. If you talk to patients, and you want to do that early on, you don't want to develop an idea and then go, you know, that is the greatest idea but nobody really perceives it that way that except you and a couple of your friends and people who work with you. I don't mean in a bad way. I mean, that you want to be able to test this idea very quickly. So once you get that idea, once you identify what is that the company should be focused on, then the question about is actually building an execution plan. And the only advice I can give is that at any given day for a company, startup, especially whether you're a founder or you're a founding team member, the list of priorities is 50, 5, 0, or maybe 100. It takes time to figure out of those 50, which are the top three that are most important and then being able to focus on those three. You know, the reason I say that no one can work on 50 priorities at the same time. But we all can take two or three priorities and say, "These are the three things that I'm going to work on today. That is this week. Those are the things I'm going to do this month." And therefore you start to develop identifying priorities. The right ones takes time. Sometimes it is a fundraising. Sometimes it's a building a team. Sometimes it's a product development. Sometimes it's all three of them, but being able to allocate your time and energy and focus is a key. People say it's the question of money. I don't think it's a question of money. Money is one of the resources, but the biggest resource we all have is a time and energy and focus. In a company of our size, we are a publicly listed company, and we now have grown from where we used to be, and it's still small. Even today, there are a lot of things we choose not to do. We choose not to go to conferences. We choose not to publish papers. If something is a priority to us, we say, "This is the only thing we're going to focus on. This is the next three months, this is our main goal." And every team meeting I have, I always remind people, three priorities. More than three, way too many. One may not be enough. But because if you can't remind people, what is the priority for the company, then you will not succeed. It is a very challenging environment to think about a startup company or companies in general. And when you have too many priorities, you tend to lose focus on. By building priorities, having priorities, executing them. You create momentum, you create confidence. They create success and you keep climbing the ladder. But truly the biggest challenge for us in the beginning of the career is that identifying which are those three priorities that matter. And once you have had some experience, then the challenge is to keep those priorities and change them as you go along, right? As you go along, you have to continue to grow. For example, in the beginning, it may be the five people you have and that may be enough. But as where we are in the company, it's a question about growth of the organization, right size, not too many people, not too little, hiring enough people so we can continue to execute on our vision and the promises that we made to ourself and to our investors. [00:16:27] Lindsey Dinneen: Thank you for that advice. That was fantastic. And such a great way to narrow it down and help people understand how to narrow down so that they can actually focus and succeed before moving on. I love that. Thank you. So, you know, looking back over your life, and of course, you've had such an incredible career that has really taken you in a lot of different directions. Could 10 year old you have ever anticipated where you'd be today? [00:16:54] Dr. Shalabh Gupta: I don't think so. I think I think we all have a what I call a true north compass. What I did think at the 10 years of age, if I can go back, maybe 10 is too early but maybe 15 or 16 or 17, that hasn't changed. Let me tell you 2 things that I always felt most inspired and excited about. Number one was that I wanted to be in healthcare because, intellectually, I like biological sciences. I felt, "My gosh, what could I do with that if I could make a difference?" And number two was that I, from very early on, I wanted to be something which could help people directly. As you know, there are many ways you can help people, but being in medicine or healthcare, I felt there was a direct impact. Now, looking back after several decades, I feel that part of the influence was my dad. My dad is a physician, continues to see patients and do pro bono work. So that had a very lasting influence on me. That helped me to think about, okay, this is what I want to do. Then being trained as a physician, then going to work on Wall Street, then there was a question about understanding how the impact can be broadened, if you will. The way to think about what I do today versus what I did, say, as a physician, physicians see, say, 10 patients, maybe 12 patients if you're seeing an outpatient basis per day. And if you're in an ICU or ICU doctor, an ER doctor, you could see more number of patients, but then smaller time. And you multiply that impact that many patients, let's just say 10 patients per day, and you work at 300, 350 days, 360 days, 365 days, don't take any break, but that is that many patients a year. What we do today has a potential to impact hundreds and thousands and millions of patients and not just in the U S, globally. So from one vantage point is just magnifying the impact. And the other vantage point is doing what I would have done before. I still love sciences every day. My job is to not just talk about business, but also think about, "How do we fundamentally solve the problem?" And having had those experiences you know, it helps you to keep yourself grounded. One part, I know this wasn't your question, but one advice I can give people who are thinking about developing their careers as an entrepreneur, if you are a founder and CEO, especially think about your career or skill set as I spoke, a wheel, a circle. Every skill that you have, some of us start with more technical background, like me and MD. Then you have to develop their finance and business skills and the business development skills. So sometimes people say, "Well, you know, ABC went to grad school and they dropped out of grad school and they started a company." That's wonderful, but think about much longer beyond a two-year, three-year, five-year time horizon. And that's what helped me to think about my career. So I worked on the Wall Street, but that gave me a finance and understanding about how public companies are valued, not just by the company, but how stock analysts value the company, how investors value the company, what moves the stock, what did Genentech to understood. That gave me the chance to understand how a big biopharma company thinks about their product development. And at Genentech, in some interactions we have had, we were looking at the products from other smaller companies, either to collaborate with them or to acquire those products. So that's a different skill set. I went very early on, as I said, in my career, I went to FDA. So even though I'm not regulatory expert, but I understand how agencies think about the product approval so that helps you to make a more of a holistic viewpoint because the business has become more complex, and you cannot just have a only business degree and you say, "Well, I'm going to succeed." Some people have rounded that up by years and years of experiences. And then there is also innate desire to learn. I learned from not just doing the work I do every day, but my, my, you know, talked a lot about it. I read anytime I get I read books that are not related to medicine, that are not necessarily related to health care, because you have to understand how to grow a revolution. You have to understand leadership skills that are not necessarily taught in schools. So, you have to find a way to continue to refine yourself, because the only way you can create a great company is to become a better version of yourself. [00:21:31] Lindsey Dinneen: Thank you so much for talking about that and for sharing your advice. And I love that image of the wheel. It's a good reminder that sometimes life takes you on very interesting tangents, but sometimes they all do merge at some point. You've got this little sliver of this knowledge that you're working on, and then this experience, and then they start building and I really love that, that, that way of thinking about it and also remembering that It's very useful. So, so like even earlier, I was struck, you talked about how there was inspiration from car batteries, right? And so how interesting is that to go from, what you might expect within your industry, here's how to solve a problem. But then you guys went outside and said, how do other people solve problems? Like maybe we can borrow from that. And I think that's really cool. [00:22:21] Dr. Shalabh Gupta: And I also think that if you stop focusing on only in your industry, learn from anywhere. Some of the best learnings that I have personally, that felt inspirational to me, did not come from biotech companies. They come from tech companies, truly. When you think about the worst, most successful tech companies like Amazon, Apple. I can go on and on, but there are things that you can learn from them. There are things you can learn from the founder of Amazon, Jeff Bezos. He talks about building Amazon and he talks about doing many experiments at a smaller scale that fail at Amazon in order for them to succeed at a few that really work. And this is where I was saying that culling the ideas, you may start with 10 ideas, but no one can develop 10 ideas, no one. And it's not because of money. People say, "Well, that if I had money." There have been numerous examples where companies have been funded with lots of money and the companies fail. Part of the problem is that when you get too much money, I think you may not realize that you still have to deliver. Because focus and execution takes really knowing what the target is, and then hitting the target and not one time and time again. Targets may change, but the companies cannot focus in 20 different things. In the beginning, you have to start with a very key thesis. [00:23:39] Lindsey Dinneen: Yeah. Absolutely. Absolutely. And yeah, so learning from other industries, and that actually kind of also brings up a thought. So as you've gone along in your career and you've had many different iterations of who you are and what you bring to the world, now, are there any moments that really stand out to you as affirming, "Yes, I am in the right place at the right time?" [00:24:04] Dr. Shalabh Gupta: Yeah, that's a very good question. And I have had a chance to think about it every now and then. So there are there, there are certain observations I'll make. You know, people always say, " What will be your dream job?" And I think the dream job for someone is the job that which you will do any given day, and you will feel a joy that you're doing it and you're not doing for remuneration. You're not doing because you're going to get paid. And we all have those different moments in time. People talk about "flow" where the time stops because you're doing something so deeply engaging that you lost track of time. You forgot where you are. You're not feeling tired. For me building of this company and the team that we have assembled at Unicycive is that flow. Any day that I'm not traveling, I am in my office. I don't work from home. I am every single day in my office. And sure we have a small team, but when we work with the team, these are motivated, driven people with decades of experiences. We feel that we are in a common mission, like we are solving the world's greatest problem. And I know that may be exaggeration, but that's how it feels. And being with them in a room and thinking about a complex problem-- and not just thinking of a problem like how big companies think about it-- but thinking of the problem in a scientific way, but delivering it a solution that only a small company can do that to me is a joy. Number two part is that as I've gone further on my career, I, I am a mentor to a number of startups from Stanford and UCSF, and many Stanford companies, many of them come with a very different problem than purely a biotech company. Since the pro bono work, I do this because I find by telling other people from their problem, I get to reflect on my own problem, and I do that on every quarter. There's one or two companies and I've been really privileged. I feel one of the greatest joys to meet with these great CEOs and Stanford has been a great collaborator. They have a program called Start X in which they have these companies that are participating in a accelerator program. And Stanford's accelerator is different and unique that they don't take any equity. They provide you the opportunity for mentorship. I was part of that program many years ago. So I meet with the CEOs and many of these CEOs will come very different problem. As an example, there is a company that's focused on artificial intelligence using interaction between a physician or healthcare provider and patient, and being able to use AI to streamline that interaction. That is a point that I saw of 10 years of clinical practice, how that communication is broken, literally is broken. Patients go to doctors, not because doctors are the world's greatest knowledge source, but patients at the end of day, they need someone to help them feel better, help them understand the problem that the physician can solve it. What ended up in being in today's healthcare system in the U. S. is that doctors have become mechanical and not because doctors are bad, because we are given these many things to document these many things to chart. If you talk to a physician, a primary care physician, many times the physician is sitting behind the computer screen. Those bedside manners are gone, like literally they are not there until you go into concierge medicine because the physician has to fill up this chart. I practice medicine. So understanding how this company and this CEO, this entrepreneur is trying to solve that problem, I lean back to the years of clinical practice. Then I lean back to the building the company. They're prioritizing it, having three priorities, having five priorities, and then being able to understand. And every company has some things which are similar, growth of your product development, continuing to advance the company, continuing to tell the story, attracting the right team members. It just gets magnified at a broader level. But the problems start similar, very similar. You know, think about when we talk about tech companies, Apple, the first thing they had to do, develop a product, then build a team, then sell the product, tell the, sell the vision, you know, and then continue to raise money. And that part is seems sometime very lonely. It also seems that I am uniquely burdened with these problems. And I always remind people, "You know, as much as you would like to think that you are unique. I assure you, it is not a problem that we are gifted with. We all have to face the same set of problems, sometimes more, sometimes less." So then you start to take them less personally. You start to say, "Okay, I'm not the first one to face this problem. These problems have happened to people like me before and they will overcome. How can I do it?" Then you'd become safe, a solution based thinking versus a place where you get overwhelmed with the problem because problems exist. And if anyone is listening to this podcast and if they've developed a started a company, I can assure you the problems come with a flood. They are not going to end ever. So it is disappointing. Sometime it feels that, "Oh my gosh, it is me versus the world," but it is not so. If you have good set of mentors, people who are not directly involved in day to day in your business, there are people who can help you think through it. And that is something that I find a great joy in talking to these CEOs, being able to help them understand the problem. And I say, you know, a couple of hours a month, but then when I go back to my own work, one that I realized this was the same problem I faced a few years ago. Two, it's a similar version of the problem I face at a slightly larger scale today. And three, being able to step out of from your own narrow zone, it gives you perspective. Then what I said to you about that problems are not, these are not personal problems. These are the problems we all face developing a product. It doesn't matter whether you healthcare. People tell me health care or product development is really hard. You talk to my colleagues, our CEOs who are running tech companies. Products in development and tech companies may seem easier, but to create a great product that truly solves customers problem, it's not easy. [00:30:30] Lindsey Dinneen: Yeah, and well, I love that mentorship and sort of teaching and guiding, giving advice to the next generation is something is of a core value of yours and something you really care about. And it actually is a great segue into my next question, which is just pivoting the conversation for fun, imagine that you were to be offered a million dollars to teach a masterclass on anything you want. It can be within your industry, what you're doing right now, but it doesn't have to be. What would you choose to teach? [00:31:02] Dr. Shalabh Gupta: I think as much as we all feel that entrepreneurship is an external game, I think it's a lot of internal mindset, being able to understand yourself better. Being able to understand who you are, what are your true core values, what really drives you. It takes time and it requires a continuous interrogation, asking yourself, "Is this really what I enjoy?" Some of us feel it's a glamour that we feel like we want to be CEO. Some of us would be better off as a CTO, Chief Technology Officer. Some of us would not want to do startups. It's not for everybody. And it's okay because you can work in a bigger company and can be, you know, people talk about entrepreneurial pursued within a large organization. Maybe that's what for you. But being able to understand yourself, it's a very important part. And I think unfortunately, formal education does not help us no matter what degrees and which schools. And it really doesn't matter whether you a science degree, MD, PhD, or your business school degree like MBA, we're all very uniquely different, and we have different values. What one person sees inspired by, for somebody else, it may be a nightmare, you know. It's a thing that people think that startups are so much fun. I read a joke. It says, "People leave 9 to 5 job to work from 5 to 9, which is 5 a. m. to 9 p. m." So I think that's because this is some truth to it. And I've said to people again and again that if making money is your objective, please don't go as to run a startup. It is probably the worst way to think about pursuing the financial part. You do something because you have a faith and belief in something. And it doesn't have to be the faith about changing humanity. It's about something that you have a unique skill set or unique product idea that you believe you can bring to the marketplace. The biggest focus we all can have is making an impact. If I can serve a large number of patients, I can serve a large physician, I will have a product that will make money, therefore, that will make money for enterprise that will make money for investors. And therefore, as a company, we will make money. It's a very simple truth, but we like to make it complicated. I really mean it. The more I got to understand this part of the process better, which goes back to the basic thing that I said to you, if you said that you have a master class, the one thing I will say to you, it's spend time to understand yourself. And it's okay to realize that what I thought I like, I don't like it. The part that I talked to you about flow, it takes efforts. I've had many careers, but when I work in my company, the time can stop for four or five hours, literally we can be working on something. And I have a team and it's not just me alone. I have a team that when we think about a problem, these are people who have spent three decades in working in different companies, large, small, many size companies, we could work cohesively, collectively, think about a problem. And that to me, it's a joy. For me, that is a creation, right? You know, we're thinking about the problem, which may be a design of a clinical trial, because we have to think we have to use brains. And I always say, "God gave us a gift, which is a neuron. So use it, let's use them." And challenge yourself, right? And the challenge in a good way, not be a condescending ending jerk and say "No, how could you do it?" I try to say to people, "Look, I understand this is how it is done, but I want to do two things. Number one, please believe me that we can do better, faster, cheaper. And number two, I promise you that whatever I'm telling you, I'm not going to tell you and walk out of the conference room. I will work hand to hand." We call it a hand to hand combat is essentially that I'm not just telling you I'm going to work with you. I want to find the solution, but we can't do that thing that are you used to. Every trial, people tell me it's going to take 18 months, 12 months, it's going to cost as much. We shrink that thing timeline cost by not 10, 20%. We talking 50%. And these are people have done this before. So, so I need the courage to be honest and say, "No, we can't do it. We have to do it faster, better, cheaper, but how?" And then asking them. So, I say, "It's okay that we walk away and we don't have a clue. It's okay. Today's Thursday. Let's come back. Take three days to think about it." But the reason is that because when you ask yourself from a place that I can't do it, the mind is start to find solution versus when you say, no, I can't do it. Because in that case, it's a subconscious mind that keeps on giving you 15 reasons why you can't do it. People talk about growth mindset. I've always said to people, "We may not be able to do this thing today, but the understanding that with a little bit of help, a little bit of patience, a little bit of it, making ourself better, we can become that company, we can become that organization." And that really requires challenging ourself. And that's where I went back to. I want to go back to this question you asked earlier. People talk a lot about entrepreneurship as if it is some very specific skill set. I think because if you know yourself, you know what is your true zone is, then you want to surround yourself places that you are either not good at, or you don't enjoy doing it, right? In the beginning, it is just you and a vast amount of problems to face. Then you start to build your team. Then you start to see yourself, "You know, maybe Bob can do this work. I really, I'm not that good at it. I don't like doing it." Then you start to rely and surround yourself with not same skill set, but the people who are complementary skill set. And that's how you build a team. That's the foundation of team. Then you build trust and you say to Bob, "Whatever you do, it's not your fault. I'm here to protect you." You don't point fingers at each other. We always remind the example of Navy SEAL. You know, I've never worked in the US Army. I was not an Army veteran, but the ethos that Navy SEAL uses where the team wins, I always tell people we are a winning team. We are not looking for MVPs, you know, because the teams win. Teams create products, teams create value. Individual glories is not useful and this is something you have to keep reminding us that we keep drilling it down and say " No, it's not Bob. It's not John. It's not James. It's us. It's as a team." Again, as you grow through the company stages, your skill set has to continue to evolve and people always say, "Well, how do you lead a team?" The first thing that I always said, "Every single person in my team, you are a leader. Why? You wake up in the morning, brush your teeth. You're leading yourself." Really! Like, what do you do with your day? If you happen to be a parent or partner, a spouse or somebody, you have people you influence around yourself, right? So instead of worrying about, "Oh, you know, I want to lead a company." First, you have to lead yourself and you have to lead with courage. It's starting a company, building a company, right? Yeah. No matter what the media tells you, it is hard. It's hard to develop a product. It's hard because the challenges are not one or two. There are many. Being able to drill down, saying "These are the three things I'll focus on. These are the only things that matter." And then if something new comes up, you have to face that challenge and put the third in your list. It comes in a different page. You know, I use this basic exercise. I have a notebook, a physical notebook and not electronic one, and a piece of paper. What are the top three priorities? And then the other part is that I've asked people to do this exercise when startup companies, CEOs come and tell me all their problems, all the things they want to do. I said, "Humor me if you will. This is the end of the year. And let's say today is we are in 2025. What would you like to tell yourself a year from now? If everything happened the best you could imagine, how many customers, how many products, what will be the stage of product, who would have funded you? Who are the people behind you?" And I asked him to write in a whiteboard. And I say, imagine, no, this is the five thing. If they write 25 things, I say, "No, this is down to five things. What are those five things you would like?" And again, everything has just gone and you can't believe you're sitting there. What will it take? Is it this? And then you start to have a goalpost, right? It's a target. Then you work backward. [00:39:37] Lindsey Dinneen: Yeah. Yeah. Well, that's great. That is such great advice. So thank you, first of all, for sharing, but I think in general, your masterclass would be so much-- you'd have to have a full day or more. That's great though. I love that. How would you wish to be remembered after you leave this world? [00:39:57] Dr. Shalabh Gupta: That's a very good question. That's one that I ask myself every day. The most important thing for me is to be who I am to make a difference for people who are around me. For me, my family is very important. I have kids and I always think about it. What will my children remember? Then it comes down to people who work with me. We want to give an experience to people. I've had people who have worked for I keep saying it two or three decades. My true wish is that I always say for whatever time they work at Unicycive, I want them to be remembering this is the best time they work for a company and that is the best hope we can do it. Because as a entrepreneur, if I can make our company the best experience, best environment, then that creates the best products. And a company like us, we realize that we are going to face challenges and it's not a question of this, the question is how many challenges. The question is not going to be, "Will the challenge defeat us?" The question is, "How do we overcome the challenges?" So it's about growth mindset, having a very distinct, clear vision and empowering people. And last thing is that what we do in healthcare affects millions of people people. Our drug is not going to be just in the U. S. We have partnerships outside U. S. We think about patients in China, South Korea, Southeast Asia. We are talking to companies in Europe. It's an opportunity to make a difference globally. And that is what keeps us going. That's what, you know, when that's when I talk with flow, that is what makes you want to work, whether it's a weekend or whether it's a late evening. And I think that is something which we all need to do to find something that is meaningful. And meaning means different things to different people in different phases of life. So it doesn't have to be, you know, I tell even my own team member, " Unicycive does not have to be the purpose of your life, but let me help you to manifest your best version so you can work well, because you are working here, you are spending your time, might as well make it meaningful for you and for the company." So finding that balance is key and it's a constant challenge. I never take anything for granted. It's a constant to my own team members. How can we make it better? You know, people always say the company grows and we started with the company. We went to IPO with one person. That was just me as an employee, which is not a common thing. I frankly don't know any other company that I've ever seen that went to a straight IPO with one employee. But that wasn't about me. It was about building the company, building the team. Today, we have 25 or so more, but it's still a small team. And people always ask me, "How do we go from 25 to 50 and it still remain the same." I said "Exactly how we became 5 to 10 to 15, 15 to 20." Because if you keep the culture same, focus same, and you remind people that it's not about who we are individually, but it's what we could be collectively. And you have it going and you know, something you're passionate about, you will give all that you got and then some more or else there is not worth fighting for because life is hard and building a product developing a technology or running a company is hard. So, either you are a full believer or else you can't do it. I mean, if you can do it, it's going to be miserable on both front. You want to do a good job and you will find it very difficult. So. [00:43:24] Lindsey Dinneen: Yeah. Indeed. Yeah. Excellent. Well, and then final question. What is one thing that makes you smile every time you see or think about it? [00:43:36] Dr. Shalabh Gupta: I think when you look back on the challenges that you once thought were unsurmountable, and then you say to yourself, "Huh, that was just a curve in the road, not a roadblock." Then you start to smile because of not because how smart you are, but how much together a team can accomplish. And you start to find, if you're working in a company setting, you start to feel that people start to feel empowered. My team says that you did it. I said, "No, we did it. I just showed you a judicious path, but you did it. I didn't do it. All I said to you is to change your framework." Because it's a framework. It's a mindset. And I keep saying about mindset because if you come with the idea that " No, I only, I need this much money, this much time, these many resources," you'll find you the subconscious mind keeps on validating those challenges. But if you say, "No, people like us have done it before I can do it, we can do it." And give them the time and space and say, "Look, you don't have to have an answer right now, but please go back and just think about it." Then they come back with the answer and they themselves surprised. But it truly requires a authenticity, a vulnerability, and being absolutely willing to fall on your face and get up and just fight again. And that's part people don't realize. People think about that every company is a smooth road up, but the companies go through the cycle. It's not when you're going up, it's what happens when you fall down. Can you pick yourself up? And it's not just with your team, but with your investors too. You know, we thought that we're going to file an NDA in 2020. You know, 2024, we had planned for everything and the whole thing was there, but we ended up in having to run an additional trial and then you have to communicate with integrity through transparency. This is what happened. This is what is there, but we can accomplish that. So then that all of all that helps you to look back a smile, laugh and say, "Okay, I accomplished that. We can do the next one." And that keeps the growth happening. And at the end of the day, we are not happy because we accomplished small things by doing small effort. Most of us as human beings want to be challenged in the right way and we feel joy in doing hard things that take a lot of efforts and once seemed just impossible to do it. And the question is, can you do it with your entire team, not just personally? And that's what inspires people. We want to be that company that people want to work for not because they need a job, not because we can take care of their 401k. I mean, those are a wonderful thing and I'm blessed that we can do all of that, because once upon a time, we didn't have any of that. So I don't take it for granted, it is something. But the fact is that what was the mission hasn't changed ever. And you know, that that is something which is worth pursuing it. And I think if people start to see that they can accomplish that, these challenges are not personal, that they are bound to come. And then they have a support group, you know, we all need somebody other than ourselves and people whom we are surrounded with somebody to hold our hand and say no, you fell down, but it's okay. You can get up. I think it's that support system, right? The more you can have it, the more different types of people you can relate to and call them friends, mentors, that helps. And I have tons and tons of them because my gosh, I mean, there are days seems like, how would I ever get out of this? As much as you may think that I have all the source of inspiration, but then if somebody else holds your hand, they say, no, you can do it. That is what gets you going to the next step. [00:47:25] Lindsey Dinneen: Absolutely. Well, goodness, this has been an amazing conversation, just packed full of incredible, helpful advice, and just very practical down to earth sharing. So thank you so much for your time today. I really appreciate everything you're doing to, to make an impact. So thanks again for your time. [00:47:44] Dr. Shalabh Gupta: Thank you very much. Thank you for hosting me and thank you for your time and interest. Really appreciate it. [00:47:49] Lindsey Dinneen: Of course. We are so honored to be making a donation on your behalf today to Feeding America, which works to end hunger in the United States by partnering with food banks, food pantries, and local food programs to bring food to people facing hunger. And also they advocate for policies that create long term solutions to hunger. So thank you so much for choosing that charity to support, and we just wish you the most continued success as you work to change lives for a better world. And thank you also to our listeners for tuning in. And if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two, and we will catch you next time. [00:48:31] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Zed Williamson is the founder and CEO of TrackableMed. He explores his transition from the advertising world to the medtech industry, where he applies neuroscience and behavior change principles to optimize medical systems. Zed discusses the importance of bridging the gap between clinical information and human connections in healthcare, and shares insights from his two podcasts aimed at medical sales and private practice growth. This discussion is packed full of practical advice for leaders in all industries.    Guest links: https://www.trackablemed.com/ | https://www.linkedin.com/in/zedwilliamson/ Charity supported: Polaris Project Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 055 - Zed Williamson [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. My name is Lindsey, and I am so excited to introduce you to my guest today, Zed Williamson. Zed is the founder and CEO of TrackableMed, a medical growth platform established in 2011 focused on delivering tangible results for healthcare professionals. He emphasizes that every system is perfectly designed to achieve its current results, and believes that by identifying and addressing system constraints, meaningful change can be achieved. Through TrackableMed, Zed applies neuroscience and behavior change principles to help private medical practices and medtech companies optimize their systems. He also shares actionable insights as the host of two podcasts, The Medical Sales Accelerator podcast, providing tips and secrets from the industry's top performers, and The Physician Growth Accelerator podcast, aiming to assist private practice physicians in balancing excellent patient care with successful practice management. All right. Well, welcome, Zed. It's so nice to speak with you today. [00:01:50] Zed Williamson: Thanks for having me. Appreciate it. [00:01:52] Lindsey Dinneen: Absolutely. Well, would you mind sharing a little bit about yourself and your background and what led you to MedTech? [00:01:59] Zed Williamson: Sure. So actually I come from the advertising world, which maybe seems strange. I thought it my life plan was climbing the corporate ladder, and I thought it was a really good idea, and then I realized I despised the industry. I just thought it was totally riddled with a complete lack of accountability to actual results. And it wasn't feeding my soul to, to be working in that space. And so I started a company called TrackableMed back in 2011 with the idea that we all are, we're working with humans have brains and brains are pretty predictable because of the understanding of neuroscience and cognitive behavior, bias and heuristics, and that we could create a company that would help medical practices grow by bringing in very specific patients. And that's when I was introduced to the medical device industry because the people and the organizations that witnessed the work we did for private medical practices first was that medical device space. And that really opened my eyes to this amazing industry where, unfortunately, patients don't know how much amazing technology there is out there. There's patients making uninformed decisions about treatment plans, and there's something better. In most every case, there's something better. So that really does feed my soul. And this idea that we kind of take ownership of it is our job to help people realize that they don't have to live the way they're living and that's really what fuels the organization. [00:03:28] Lindsey Dinneen: Yeah, well, that's incredible and very important, obviously. So I want to go a little bit further back in your personal story first, and then I definitely want to hear all about what you're doing now. But back at the beginning, could you have anticipated that you would end up in this field and doing the work that you're doing now? Or was this just a happy evolution over time? [00:03:48] Zed Williamson: I had major knee surgery when I was 16 years old and I thought physical therapy was really cool. Like I, that's where I thought I wanted to go. And too much math and science. So, so it was not the direction for me. And I really wrapped my head around human behavior, this idea that everything is so predictable. Our brains were built a long time ago to exist in a world that doesn't exist anymore, and when you understand the bias and heuristics of the brain, you can literally create and predict behavior. So that's why I went into that advertising space, because that felt like a better fit for that. The way I came back to medical was, I actually heard a commercial for a procedure that sounded really interesting, and it was a horrible commercial. And I just, I did some research and realized that no one who had what this procedure would fix would ever think that procedure would help them. But once I realized what that procedure was doing, it was almost like I had to carry the flag and run this up the hill, because there's people who don't know that this exists, and that's how I kind of dipped my toe in and learned, and then I just got honestly addicted to the curiosity around what else is there out there from a technology standpoint. [00:05:13] Lindsey Dinneen: Absolutely. So you started exploring what else was out there and then you formed your own company, which is a consulting firm and more. Could you speak a little bit about that and how the company has evolved over time too? [00:05:25] Zed Williamson: Yeah, so started TrackableMed in 2011 really to help those practices. And what we learned is that medical practices generally just kind of-- this may sound strange-- but they generally sit around and wait to see what patients show up. And there are some amazing technology opportunities out there. And even medical device reps will, like when I say this, they'll go, "Yeah, I hear that all the time." And that is that a lot of times physicians are looking for perfect patients to use technology. And it's because maybe they're new to it and they just, they want that perfect patient. So what we were good at is getting the perfect patient. And what we realized is the services we were providing direct to private practices also worked for medical device companies because if medical device companies took ownership of educating patients about the life they could be living, you really drove massive adoption of these devices. So if you think about a physician, the training they go through, generally they're not really big to change, right? That's kind of built into them. They spent a long time learning abnormal anatomy, normal anatomy. They see abnormal and they go, "Ooh, we've got to fix that." And that's their mindset. So when you're a medical device company and you have something that is better, and you know what I find is 99 percent of the people I meet in medical device are really passionate about getting the word out because it's better, right? It's like, we don't have to do it in the old way. You're doing a surgery that was done in 1942. There's something different now that's actually got better outcomes. So anyway, but physicians are biased against that change. We see a lot of biases that pop up in that behavior. But one of the quickest routes to changing that behavior is have patients ask for it. Because it removes the, kind of that bias that they're not doing something they were trained and they're actually now serving the patient. And so what we started doing with the Medical Sales Accelerator is working with medical device companies on creating programs to make it so patients were saying, "Hey, doc, do you do the blank procedure?" And that would help drive adoption. [00:07:39] Lindsey Dinneen: Yeah. Okay. That's incredible. So you have this consulting portion, which is huge. And then you also have podcasts. And I was wondering if you could share a little bit about your inspiration for introducing these podcasts to the world and what you hope to accomplish through these as well. [00:07:54] Zed Williamson: Sure. And the two podcasts are very different. The Medical Sales Accelerator podcast is about putting the spotlight on the best of the best in the medical device industry. We talk to authors that have written books that have really impacted the industry. Jeffrey Moore was one of my favorite episodes. That was awesome. And the challenger sale, like there's a lot of really cool stuff there. And what we really built it for is we wanted people, who had some windshield time, to be able to listen to something that was going to make their next interaction with their customer better. And so it's an interview style podcast. It's leadership in medical device. Sometimes it's sales leadership, sometimes it's authors, but it's all around this incredible industry and really just a conversation about these little tips and tricks that people are using that help them be more successful. And that's been great. That podcast is four, four and a half years old. So we've been doing it a long time and I've got some really good feedback. The other podcast is the Physician Growth Accelerator. And this podcast is not interview style. It is designed to give actionable tips to private practice business owning physicians. The episodes tend to be eight to 12 minutes and it's, you can walk away, implement something that you heard. We do share it with the medical device community as well, because a lot of times if you're a medical device rep and you have a piece of technology that's very similar to competitive to competitors, you're always looking to how can I bring more value? You know, what can I do on top of the technology? And so we found a lot of medical device reps will share episodes from The Physician Growth Accelerator to their customers because they witness firsthand what is going on in the practice that can be very frustrating. [00:09:54] Lindsey Dinneen: Yeah, well, both of them sound incredible, and I appreciate that you have two separate podcasts that are really impacting the industry. And I'm wondering, getting to speak with all these incredible people and hearing their advice and inspiration and things like that, what are some of the common themes you've picked out from these in terms of challenges within the industry that may be, you know, through these conversations, or even your own consulting work, that you can help solve? [00:10:17] Zed Williamson: Yeah, so I would say the biggest-- is such a good question-- the biggest challenge is something called curse of knowledge. And curse of knowledge is this idea that when you foundationally understand something, it almost automatically makes you worse at communicating it to someone who doesn't, right? And you see this in sales a lot, where a salesperson goes, "Oh, you know, this one's great because it's got the X942 va ba da ba." and the person buying has no idea what that means and you're not helping. And the thing that medical device very commonly miss, is they have this passionate route for the existence of their technology, the years, the effort, the expense, and they are thinking big picture, like it's really important that we achieve these things because we are changing lives. And then, they go to their customers, and they show them the X948, you know, vibidabidabada, right? And they're just trying to live in this world of, "Well look, this one has a number on it," or, and that's where we see the biggest challenge, is: physicians, surgeons, they're humans too, they connect with stories. They are actually in it to help patients. And that big disconnect is a challenge that you see almost every company face. Part of it is cause they're so excited about all the work they did that they're not using the foundation that got them through those speed bumps to actually help someone else wrap their head around the concept. You know, it's just like if you cook an amazing meal, the person who watched you do that appreciates it much more than if they just tasted the exact same meal just served to them. If they see the effort you went through and why you did slice the onion this way or whatever it is-- maybe that's a weird example-- but, it's the biggest myths that we see across medical devices. They get trained to clinical information and they go try to have clinical conversations because they think doctors are going to make a logical clinical decision. But humans are not logical. We don't do that. So that would, that would be number one. [00:12:24] Lindsey Dinneen: Yeah, that's absolutely core. And then how do you bridge that gap? Or how do you encourage people to think through bridging that gap between, yes, we love that you have all these shiny features that are very important, but they don't necessarily mean a whole lot to your end user just yet. So how can you help bridge that gap between all the shiny features that the engineering team wants to talk about versus how does this benefit that end user or the physician or whoever needs it? [00:12:52] Zed Williamson: So a lot of it is understanding truly what the bias that this person may have against changing. It could be that they're uncomfortable with change. It could be that they don't want to make a decision that potentially is worse than the current thing that they're offering. And if you understand what is holding this person back, it's going to put you in a better position to understand that perspective. But your conversation needs to be about aligning goals, asking questions. The medical device so often talks too much. They tell, as opposed to what's important, what's frustrating, what do you wish. "Tell me about a patient that it crushed you because you couldn't help them." So it's about connecting on the human side to see, is there actually a reason why this person should do something different? If you go to a neurosurgeon and they don't do disc replacements, and you just try to bulldoze in and say, "Hey, a lumbar disc replacement is better for a patient than putting in a cage," you're not getting anywhere with that person. But if you can talk stories of patients and help them understand from a life impact, because physicians only get to experience a blip in time in the health care journey of a patient, and it has to be that way. And if you can help them understand kind of the parentheses around the rest of that person's life, like what led that person to need this, and after they leave, what is their life going to be? And now, if your device influences what that impact is, that's where you have the most leverage. [00:14:37] Lindsey Dinneen: Yeah, absolutely. And so, you know, one thing that struck me as I was reading through what your company does and all the value it brings to the world, something that really stood out to me was you said something along the lines of you are passionate about balancing patient care with the business side. So what do you find in that particular realm are the gaps? Because obviously, like you said, these are very caring individuals, super smart, very capable people, and they're experts in their field. So how do you help them to marry that expertise with the business side? [00:15:07] Zed Williamson: Yeah. So, this goes back to bias and sometimes people will have a belief about something. Here's what's interesting about our brain. So someone may tell you that we can't control emotions, that emotions happen. And I would slightly agree with that. The reason I say "slightly" is because an emotion happens based on a belief and we can control our beliefs. And so what can happen is if someone believes that financial success is not good, then they are going to have an emotional response related to anything that goes down that path. But that is a belief that you can change. And, the biggest issue with business and healthcare is, there are organizations, unfortunately, that they're not seeing the patient in, from a standpoint of what we do. They're looking at a bottom line only, and that's why their organization exists, and I'm a believer that when you only focus on that, at some point, it's not going to go well. If you focus on the patient, but be smart around the structure you have to the organization, you can build something that's very financially successful that's helping more patients. You're building a moat around your business so that you can continue to help those patients and we're helping more lives. But it gets to belief first. If someone believes it's bad or wants to pretend they believe it's bad, because that's the thing too, then that creates that emotional response that really puts them in a position where they are going to have a hard time succeeding. And if you don't succeed on the business side, you haven't helped any patients. There are medical device companies who've gone out of business and it's not because their technology was bad, but they didn't go to market in the right way. And how many people did we hurt by allowing that to happen? You know, if we actually felt like there was value, then we need to take ownership of creating something that can really sustain and help as many humans as possible [00:17:23] Lindsey Dinneen: Yeah, and that's really great advice and insight, and you have this reoccurring theme, which is you have this psychology background and interest. Where did that element come from in terms of how did you continue to even elevate your own beliefs so that your emotions could also follow suit? But where did this whole thing come from that has allowed you to be so successful personally and then for your clients from that neuroscience and psychology perspective and background? [00:17:51] Zed Williamson: You know, the origin story of that stuff comes from a long time ago, me wanting to help clients and realizing that the advertising world was broken because they were awarding creativity, and creativity does not equal success. The advertising world actually really hurt themselves back in the late 50s, 60s, where they started giving awards for creativity and it changed the reason people did something. "So, hey, let me create something so I win an award." "Well, did it help the company that paid you?" "I don't know." That's not good. And so I've always been a believer that we really do exist in a state where we are always witnessing perfect outcomes of our current system. Someone might go, "Well, there's no such thing as perfection." And I don't mean it's perfect from my perspective, but the system was perfect at creating that outcome. If I go and walk into a room and stub my toe, me stubbing my toe was the perfect outcome of the system I operated: the light not being on, shoes not on, not paying attention. And so the same thing with behavior. And if we look at, you know, humans are pretty interesting from an organism. We have this fancy brain. We survived in a world we probably shouldn't have. We're not as strong. We don't have claws. We don't have big teeth. Most of us are not as furry. But you know, we still survived and it's because of the brain and the brain has this one thing to do: stay alive. It does not know a grocery store is around the corner. It does not know that when someone cuts you off, that it wasn't a saber toothed tiger trying to eat your family. So if we just allow this brain that did a really good job of keeping us alive, if we allow it to continue running, then we're limiting the evolution of ourselves from what we can really be aware of and understand. The idea that someone can make me angry is a really silly idea. It's not true. Anything you do, you can't make me angry. I have to believe something. Now you could do some things where you could maybe get a sense of what I likely believe and you might take some action and I would be angry, but I'm never going to give that power to you from the standpoint of you can actually make it so. You can't make it so. And, there's an example I like to use to just help people realize how much perspective is in our control. You're driving down a road. It's 45 miles an hour, and you see this stop sign up on the right hand side coming up. And this car pulls up to that stop sign and there's something about the car or the driver, and in your mind you go," They're going to roll this stop sign and I'm going to have to slam on the brakes." It just, it pops into your head. Everyone listening right now, I know it's happened to you. Sure enough, car pulls in front of you, you slam on the brake so hard everything in your chair or your seat hits the dashboard, your shoulders tense up, you get angry, maybe you say some things about this driver or the car, like, "I knew it." Blah, blah, blah, blah, blah. And so people are feeling that right now. You weren't harmed. Okay, there was no accident. You hit the brakes. You might get to your destination three seconds later than you originally were. But here's the rest of the story. It was a mom driving and her child was in the back seat bleeding to death and she was going to the ER. Everybody's shoulders just went, oh. Wait, so now you're not angry, but nothing changed, right? You still hit the brakes. The stuff still hit the dashboard. You're still gonna be three seconds later than you were. But our brain is designed to treat things with this fight or flight. And when you can understand that everything you say to people can be more helpful. Every witnessing of other people's behavior can be more helpful. In a work environment, if someone acts defensive, it's probably not because of you, it's they're in a state where their brain is trying to tell them they're in danger even though they're not, and they don't know that the mom was rushing her kid to the ER. And so it was kind of like squeezing toothpaste out of a tube for me. Once I really wrapped my head around that understanding, I can't get it back in the tube, like it's now it's got to drive everything, right? Because there's so much value in it. There's so, I get really passionate because everybody on the planet can be experiencing more joy than they currently are without anything different in their life because it's purely perspective and understanding and knowing your own beliefs and then choosing, do I want that belief or does that belief actually serve me? Why do I believe that? Maybe I shouldn't believe that. So anyway, long answer. I don't know if I actually answered your question, but I kind of go off on a soapbox in those scenarios. [00:22:39] Lindsey Dinneen: Love it. And I really appreciate that particular illustration because I think that was the perfect way to capture how much responsibility we are able to take for ourselves and our reactions to things. And it's such a good reminder too, that in the daily we get to choose. We get to choose what affects us, what doesn't, what brings us joy, where we can give grace and patience in a circumstance that we maybe know nothing about. Yeah. I love that. So, you've gotten to speak with so many incredible people through your podcasts, through your consulting, and of course, you've worked with some pretty spectacular companies. What are a couple moments, or maybe a moment, that really stands out to you as just driving home the idea that, yes, I am in the right industry at the right time? [00:23:21] Zed Williamson: So I love learning. I am really curious. And I don't think that there is a way for me to learn more faster than being in this space. There's things that we know about just human behavior today that it wasn't known 15 years ago. The technology is incredible. I had the CEO of a company that's building a remote control pill that you swallow and they swim it around your stomach to be able to scan your stomach lining for cancer without an endoscopy. They could ship it to somebody and control it from the other side of the world. That is fricking cool. So there's so much unending opportunity. I think the exact, like I've always enjoyed history. I like learning, but I couldn't be in a role where that was my job. Like, "Hey, let's learn what already happened." I do like the context. I like thinking about humans, ancient humans doing things and how it affects us today. But I just think this space is, it's infinite from the standpoint of what's possible, what technology there is, the impact of that technology with the people that work in the industry, that work in health care and the patients. So it's just to me. It's just a vast place to play. [00:24:44] Lindsey Dinneen: It's so true, and you can't get bored. Or if you get bored, that's entirely your fault, I would say, because there's so much innovation. And you know, like we were talking about even before pressing play, there's so much care and dedication and passion in this industry to really make a difference, and that alone is inspiring to even simply bear witness to. [00:25:06] Zed Williamson: Yeah, absolutely. It's a big part of our entire organization. If anybody calls it up and says, "Hey, why do you guys actually do what you do?" Anybody would tell you it's to help people realize that they don't have to live the way they're living. And if you know that someone is about to have a procedure that is from 1942 and they have one that's better, we call it, and this might be strange to share publicly, but we call it "pulling kids out of traffic." Like you wouldn't walk down a street and go, Oh, look, there's that kid in traffic. "I should just let him." You would do whatever you could to pull the kid out of traffic. And that's what I think medical device is really positioned, that's what they should be doing. They should be seeing these patients that they're helping and really attacking it from that level of passion. [00:25:53] Lindsey Dinneen: Yeah, I love that. Yeah. And so, completely pivoting the conversation just for fun. Imagine that you were to be offered a million dollars to teach a masterclass on anything you want. It could be within your industry, but it doesn't have to be. What would you choose to teach? [00:26:10] Zed Williamson: Self awareness, 100%. The power your mind has and understanding that you are likely not under attack, that joy is not a destination. It's not a finish line. It's a decision. Man, if I could wave a magic wand and just make that where people really got it, it would be, that would be so cool. So I would definitely do that. And for a million dollars, man, I'd make it a pretty serious class. Lots of follow up, maybe even some role play for a couple of years. But the, yeah, that would be amazing. [00:26:43] Lindsey Dinneen: It would be amazing, yes. And I particularly like your magic wand idea. I think it would change the entire landscape of the world, so I'm all about that. Excellent. And how would you wish to be remembered after you leave this world? [00:26:58] Zed Williamson: "That he put aside his own discomfort and helping me realize what was possible." We have so many interactions with people and we can say like, "Oh man, you know, this person doesn't realize this." But then a lot of times the brain is saying, "Well, it's going to be uncomfortable if you bring it up." And so I think that cause I know I irritate some people and it's all, it's always out of love. But... [00:27:24] Lindsey Dinneen: Right. [00:27:25] Zed Williamson: ...but yeah, I would say that, "whatever he could to help me realize that there was more for me." [00:27:32] Lindsey Dinneen: That's powerful. I love that answer. Yeah. And then final question. What is one thing that makes you smile every time you see or think about it? [00:27:42] Zed Williamson: Mmm. My family. Two boys and my wife, Nico, Elijah, and Chantel. We just have so much fun. Late teenage boys, well, actually my oldest one is 20 now, but it's all about laughter. What's cool is the sense of humor is so powerful because there's literally-- this would really could annoy some people-- there's nothing that can't be funny, right? It's always belief, right? And if you can have that mindset, and my family does, so anytime we spend together laughter is going to be happening soon. [00:28:16] Lindsey Dinneen: Yeah. Well, it goes back to your whole thing about joy, too. If you choose joy, then there's also a lot more opportunity for laughter, too. Or it just comes a little easier, perhaps. [00:28:27] Zed Williamson: Yep. [00:28:28] Lindsey Dinneen: Excellent. Well, this has been an incredible conversation. I personally was not even expecting this deep dive into psychology, but I love it. It's fantastic. And I just really appreciate you sharing your passion and heart for the industry and for helping bridge the gap between the expertise and then reaching the people that they're intending to reach and having sustainable businesses so that people can continue to make a big impact with their work. So thank you for the work you're doing with the world. And thank you for your time today. I really appreciate it. [00:28:54] Zed Williamson: I know the work it takes to put into a podcast. So I appreciate what you're doing and appreciate you having me on. [00:29:00] Lindsey Dinneen: Of course. And we are so honored to be making a donation on your behalf as a thank you for your time today to the Polaris Project, which is a non governmental organization that works to combat and prevent sex and labor trafficking in North America. So thank you for choosing that organization to support, and we wish you continued success as you work to change lives for a better world. And thank you so much to our listeners for tuning in. And if you're feeling as inspired as I am right now, I'd love if you'd share this episode with a colleague or two and we will catch you next time. [00:29:36] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Mildred Zayas, a global supply chain executive with over 25 years of experience in the medical technology industry, shares her transformative journey from her early career in Puerto Rico to leading strategic initiatives at Johnson & Johnson. She emphasizes operational excellence, supply chain optimization, and mentoring emerging leaders. She discusses the importance of continuous learning, servant leadership, and the exciting future of MedTech with advancements in robotics and AI. Mildred also highlights her passion for empowering underserved communities and her involvement in nonprofit organizations like America Needs You.    Guest links: www.linkedin.com/in/mildred-zayas/ Charity supported: Feeding America Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com.  PRODUCTION CREDITS Host & Editor: Lindsey Dinneen Producer: Velentium   EPISODE TRANSCRIPT Episode 054 - Mildred Zayas [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I'm delighted to welcome Mildred Zayas. Mildred is an accomplished leader with extensive and global expertise in strategic planning, operational excellence, and supply chain optimization within medical technology and life sciences. Well, thank you so much for being here today, Mildred. I'm so excited to talk with you. [00:01:15] Mildred Zayas: Thank you for the invitation, Lindsey. [00:01:17] Lindsey Dinneen: Of course. Well, I would love it if you would start off by sharing a little bit about yourself and your background and what led you to MedTech. [00:01:25] Mildred Zayas: Of course. I'm a global supply chain executive with over 25 years of experience in the medical technology industry. I have had the privilege of leading transformative initiatives at Johnson and Johnson, where I optimize manufacturing network, particularly in Asia Pacific, resulting in cost savings, inventory improvements, improved customer service levels as well. We also have introduced what I call the manufacturing ecosystems, which is instead of focusing on the product design on the customer only, which is important-- I'm not saying that it isn't-- but we also want to introduce a product that, of course, is high quality and dependable, but we also enhancing the efficiency and manufacturability is what is called designing for manufacturability. Product design and manufacturing don't have to be mutually exclusive, and that is something that I definitely learned through my career. I was born and raised in Puerto Rico. I'm particularly dedicated to empowering underserved communities to achieve greater economic and career advancement. My career is driven by a commitment to operational excellence, strategic innovation, and mentoring emerging leaders to achieve their full potential. [00:02:43] Lindsey Dinneen: That's amazing. Thank you so much for sharing a little bit about that. So I would love to go back a little bit further and start. When you were young, did you have any idea that something like this was something you wanted to do? What was your dream? What were you thinking about? [00:02:56] Mildred Zayas: So I have to say yes. And I always, I'm an engineer by training and I always wanted to be an engineer. My uncle was an engineer. Even though he actually opened a university and did something different, he was pretty much, you know, I guess the big person in our family, everybody looked at him. We all wanted to be like my uncle, right? Unfortunately, he passed away. But with that, I always knew that I wanted to be an engineer. That's why I went to engineering school. Eventually, being an industrial engineer led me to the manufacturing industry. I started my career in Puerto Rico and manufacturing was big in the nineties. Do we still have manufacturing? Not as much anymore. But that's how I started in the industry and in the manufacturing industry. And then I progressed through roles of increasing responsibility and continuing supply chain in leadership roles. But yeah, everything started by my family, my uncle and seeing what he was doing as an industrial engineer. And I wanted to be like that. Yeah. [00:03:58] Lindsey Dinneen: Oh, I love that. [00:04:00] Mildred Zayas: I'm also good in math. [00:04:01] Lindsey Dinneen: That helps. Excellent. Well, you know, you mentioned during your opening how the values and the core beliefs that you hold to still came from your upbringing in Puerto Rico, and I was wondering if you mind sharing a little bit about that. [00:04:18] Mildred Zayas: Sure. I grew up in a family, my parents, they love to serve. So when I grew up, actually, my mother was always with a cause. She was always helping people. She's still serves. She's 81 years old and she still has a number of ministries and serves. So that's what I saw with my parents since I was growing up. My father used to cook for homeless people when I was a teenager. So at that time, frankly, it bothered me a little bit, but now I can appreciate because really it's about serving and giving others. It's not just about yourself. And I have to thank my parents because they actually taught me that, and not only taught me that, they model it throughout their actions. [00:05:01] Lindsey Dinneen: Yeah, absolutely. And how has that value of service and giving back impacted your own role as a leader and how you relate to other people? [00:05:11] Mildred Zayas: Absolutely. So and that's interesting that you say that because when you talked about leadership, I always say, "be present, be transparent." You need to let people know what you stand for. But I also embrace what I what is called servant leadership. Of course, leadership is about direction and to have a vision and have followers and all that. I'm not saying that it isn't. But when you look about servant leadership, when you are really helping others, collaborating, and so people can move into where they want to go. So that's pretty much the way is looking into others and empowering them to reach their full potential and fostering collaboration and where trust and growth at the core of every decision. [00:05:57] Lindsey Dinneen: Yeah, absolutely. So you've had a really long career with Johnson and Johnson specifically, and it sounds like you have had a lot of different opportunity there. And I was wondering if you could speak a little bit towards your experience and how starting where you did and then now where you are, what was the progression like? What did you learn along the way that was really beneficial in helping you achieve the next milestones? [00:06:22] Mildred Zayas: First of all, let me just say Johnson and Johnson is a big company now, of course, 90 billion dollar and all that. But nowhere I started in the mid nineties, right in the early nineties, I should say. So, so it was a different type of company, number one. Number two, J and J has always been very decentralized, meaning each company-- we call it franchises now business unit-- each business unit is kind of run independently. So I started my career with Ethicon, which is the suture manufacturing company, and that's where I grew up and I worked most of my career on and off. But I was also able to move to other sectors on other franchises as well. So I started in Puerto Rico as a second shift manufacturing supervisor shortly after I had a previous job after college in the pharmaceutical industry, also in manufacturing. But I definitely wanted to be a manufacturing supervisor. And in pharmaceutical industry, you need to have a pharmaceutical background, and it was going to be more difficult for me to be in manufacturing. So Johnson and Johnson offered me an opportunity and I took it and I started in the second shift. From there, I progressed to what now is called process excellence, but it used to be called industrial engineer. Once again, C. I. P. process improvements and all that. Then I move into the planning organization materials management, we call it at the time, all in Puerto Rico. I've worked for five years when Ethicon in Somerville, which we had the headquarters, they called me and they offered me an opportunity to move to New Jersey. And this was in, my goodness, in 1999. So, so I moved to, to, to New Jersey and started working, of course, in the planning organization, supply planning, planning inventory management and all that. But then there was a big opportunity for me, and it was a transformative initiative in Edinburgh, Scotland. It was about manufacturing consolidation and optimization. So there were difficult parts because we closed a manufacturing plant of 800 people, yet we move operations to different places. So in the end, I mean, we definitely grew. It was tremendous for me to work in that initiative. It was my first global experience. I was in a commuter assignment in Scotland. And I had a global team with different functions, different areas, people in Belgium, people in Germany, people in China, because we transfer process to a fair places, people in Puerto Rico, of course, in New Jersey and in Scotland. And I can tell you that I made good friends that still they remember my birthday and we continue connecting via Facebook and all that. So, so that experience was fantastic on gave me a good perspective. I came and talked to my boss at the time and say, "Listen, I already implemented a project. It was fantastic. It was great. But I want to work on strategies." And something that I've always done, and maybe you ask me later about an advice, just ask. You know, people can say no, but I mean, just ask for what you want. So I did! I asked and I got it. I was promoted to a senior manager at the time of my strategy development and deployment. So we were developing the five to seven year initiatives on where you want to have a manufacturing presence, whether make versus buy and those type of things. It did great. It was fantastic. And then I'm like, okay, I have work in the U. S. I have work in Europe. You know, what about Latin America? Because Puerto Rico is kind of in the middle. It's not 100 percent Latin America, especially from a work environment standpoint. We're reporting to the U. S. So I actually moved and worked for Johnson and Johnson Latin America. I was based in Miami and I supported our cardiovascular business. And I was there four years, and then the other two years, our diabetes care business. So I did that for several years and then I moved back to New Jersey where I actually continue developing strategies, was promoted into other directorship level, and work closely with Asia Pacific. That's where I created strategies in the region and help develop the network based on centers of excellence, reduce, of course, the footprint using a lot of suppliers and contract manufacturers as well. We try to optimize the model. So, it was exciting. I actually got to live in Singapore for a year and a half. So it was fantastic. I was there in an international development assignment. Then I came back and I actually went back to Puerto Rico to work in global supply planning. I mean, that's what I started. As I mentioned to you, I did a lot of planning early on, and there was an opportunity there. Even though it was based in Puerto Rico, it was a global opportunity. So I have responsibility for for team in Brussels. I have people in Juarez Mexico, of course, in New Jersey and I was based in Puerto Rico. Did that for a couple of years, and then actually I moved to consumer, to Johnson & Johnson consumer, and I was there for four years. And it was interesting because it's a very different pace, the pace of consumer goods versus medical devices. But it was a great experience. And once again, J and J is big. So I always wanted to take advantage and do different things. After that I came back, late in 2021, back to medtech. It used to be called medical devices by the way, but now it's medtech. And I came back in a strategy and project management role. I have responsibility to develop the overall strategies. But it was not for say, Ethicon, like before one of the franchises, right? It was for all of them. So I was working with orthopedics, of course, surgery, vision care, and then our interventional cardiology. So that's been my career in J and J. I always say three areas or four for me: manufacturing, obviously planning, project management, and strategy. So there's four. Well, I sometimes I put project management and strategy together, but you can call it three or you can call it four. [00:12:33] Lindsey Dinneen: Yeah. Excellent. Well, thank you for sharing more about that. It's an incredible career path you've had and taken you literally all around the world. And something that stood out to me as you were talking is, I'm so intrigued by your story, and courage seems to be a resonating theme. And so, between your willingness to step out of your comfort zone and go try and go learn and keep elevating your own knowledge and career and expertise, but then also to have the courage to ask for the things you want. I loved that advice so much. So I was wondering if you could maybe talk a little bit more about how did you have this courage to ask for what you want and how did this courage serve you as you continue to take advantage of opportunities in very new avenues for you? [00:13:22] Mildred Zayas: Sure. Once again, I have to go to my mother. I come from a pretty, pretty matriarchal family. My grandmother, my mother, they were very strong women. But she always said, "Ask, and you shall receive." [00:13:35] Lindsey Dinneen: Yeah. [00:13:36] Mildred Zayas: Quoting the Bible as well. But also you have to deliver and you have to execute. I mean, you don't have credibility if you don't do the job. So you have to do your homework. And then once you establish that credibility, once the organization knows that you add value, then you can start asking. And once again, the worst thing that can happen is that they say "no." In my experience it's never been no. The worst has been "not now," but it happened two years after. So you know what? You have to tell people what you're looking for and what you would like to do. But again, don't forget you have to deliver too, critically important. [00:14:17] Lindsey Dinneen: Yeah. Yeah. I love that. Well, and to your point, even if the answer is initially no, it's not usually "no, not ever for the rest of your life. It... [00:14:26] Mildred Zayas: Yet. Not now. [00:14:27] Lindsey Dinneen: ...Yeah, it's not yet. Exactly. So I love that, and your willingness to embrace that courage and do those things. So it looks like also, I know service is a big theme in your life, and one thing that I noticed when I was just glancing at your LinkedIn profile is that you have had opportunities to work with a lot of different interesting nonprofit organizations. America Needs You popped up and I was curious if you would speak a little bit about your experience with that. [00:14:53] Mildred Zayas: Oh, absolutely. And thank you for asking that question. America Needs You is an nonprofit organization that works with first generation college students and how they transition from college to the work environment. I'm passionate about it because I truly believe in education and upward mobility, especially in underserved communities. So what they do is definitely fantastic. And the program is a, it's an intense programs. When you commit to be a volunteer, you work two years with your student there, since they're sophomores until graduation, and we help them prepare for interviews, resumes, what to wear, and those type of things, but it is a tremendous and fulfilling program. And you need to have in mind that, for some of us, it makes sense. I always mentioned my mom, she instilled in me, she worked very hard, etcetera. But not everybody has the model, right? I mean, when you're a first generation college student, you don't know how to navigate. And I love the program because helping others navigate I, I mean, I really enjoy it and sometimes I think that I get more than what I give, for sure. When I see people succeeding and doing well in their careers. [00:16:08] Lindsey Dinneen: Yeah. That's really special. Mentorship is such a wonderful key component. I'm sure all of us have stories of these people who have come into our lives and helped lead us to the next thing or given us the crucial piece of advice at the right time. So thank you for being that person for others too. That's really special. [00:16:23] Mildred Zayas: Of course, love to do it. [00:16:25] Lindsey Dinneen: So I. Yeah. So I know one thing that's probably on everybody's mind is supply chain management, and since this is one of your areas of expertise, I was wondering if you could speak a little bit towards what should we look forward to in the future, especially, AI is such a big buzzword, but it is reality now. So I'm curious what are some of your takeaways? What are things that you're looking to as time goes on and technology changes? [00:16:54] Mildred Zayas: So, definitely robotics and digital are going to change the game. And you mentioned AI, which is part of that. But if you think about, before it was called medical devices, because really, it was developing devices, but those devices are going to become smarter now, right? And what's important, I think, understanding the robotics, we're going to transform the way we do surgery. Maybe a doctor is in Germany and is operating in a patient in the U. S., right? So those are the type of things that we need to be open and understand and definitely stay current on the new trends. I believe, again, digital and robotics is the future of medical devices or medical technology, for sure. [00:17:38] Lindsey Dinneen: Okay. Yeah. Excellent. So you've had so much incredible experience literally around the world. Were there any moments or a moment that stood out to you as just really reinforcing that you were in the right industry at the right time? "Yes, I am here for a reason." [00:17:56] Mildred Zayas: You know, I mentioned the strategy in Scotland, but that was definitely a defining moment in my career. Because I had the opportunity. I was quite young, but I led the transformation of a big team. I mentioned 22 people. It was a complex initiative, a lot of alignment from cross functional teams, aligning different regions, managing diverse stakeholders in optimizing overall operations. And there was a challenge to balance operational efficiency with the business goals. But while I was doing that, it really confirmed my passion for supply chain leadership. It was incredibly rewarding to see how our collaboration improved performance, reduced the cost, strengthened really our global manufacturing network. And that experience reinforced my belief in the power of strategic planning and teamwork to drive meaningful transformation. [00:18:53] Lindsey Dinneen: Yeah, of course. As you look towards the future for your own career and even for the future of medical devices, I know we touched on sort of your thoughts with that, but as far as your own career goes, what are you looking forward to coming up? What's your next challenge or adventure? [00:19:07] Mildred Zayas: So I'm glad you asked that question because I'm thinking more and more-- I've been 30 years with J& J again-- but I'm looking more and more into a portfolio career. So where I can definitely continue doing some supply chain strategy, et cetera, perhaps in, in, in a consulting way, but I would also like to serve on boards, participate in podcasts, for example. So I want to do a little bit more of that. I have done for many years, the kind of nine to five one thing in different scales and in different positions, et cetera. But my next step definitely is more into a portfolio career. So I'm not going to do one thing. I'm going to do more than one thing. And of course, I'm going to be using my background and my expertise for that. But I can also combine my passion for helping others [00:20:00] Lindsey Dinneen: Yeah, absolutely. Well, that's exciting. I am looking forward to seeing how that develops. I'll be cheering for you, rooting for you that whole time. Speaking of, you had a great piece of advice, and that was to just ask the question. And I'm wondering if anything else that pops into your mind, just pieces of leadership advice that you might give, especially to someone who's earlier on in their career, and might just need a little confidence boost. [00:20:26] Mildred Zayas: Yeah, obviously, ask the questions is good. But my best advice is really to focus on continuous learning and adaptability while building relationships. Relationships are critically important. The medtech industry is fast paced and constantly evolving, so it's crucial to deepen both our technical expertise and our business acumen. Sometimes you need to seek cross functional projects, mentorship opportunities to broaden your perspective. So it might be above and beyond your day to day job, but it doesn't matter. Ask for those opportunities. Also building this network is critically important, and it's going to help you, demonstrating resiliency and it's going to set you apart as a future leader. I believe Theodore Roosevelt say something that I like: "Whenever you're ask ed if you can do a job, tell them, 'Certainly I can!' Then get busy finding how to do it." So that's the way to do it. Don't stress yourself. Don't be afraid. Be excited. Fear paralyzes us while excitement allows us to move forward. [00:21:34] Lindsey Dinneen: That is such great advice. Thank you for that. I love that. And that's so great because you're absolutely right. You can use that strong emotional pull that often feels like fear, but what if you reframe it and think, "Hey, actually this means I care a lot and I'm very excited about this." So let's use that as energizing, not debilitating. [00:21:52] Mildred Zayas: Correct. Absolutely. [00:21:55] Lindsey Dinneen: Absolutely, absolutely. [00:21:57] Mildred Zayas: By the way, one of my mentors told me that. [00:22:00] Lindsey Dinneen: Ah, back to that. I love it. Full circle. [00:22:05] Mildred Zayas: Absolutely. [00:22:07] Lindsey Dinneen: Well, pivoting the conversation a little bit, just for fun. Imagine that you were to be offered a million dollars to teach a masterclass on anything you want. It can be within your industry, based on your experience, but it doesn't have to be at all. What would you choose to teach? [00:22:24] Mildred Zayas: That's a very intriguing question. And it's something I don't believe they give in college these days, but something along the line of advancing through corporate structures. I would love to teach young professionals how to navigate workplace politics, negotiate promotions and manage career transitions, something along those lines. We were educated very tactically, typically. Like in my case, I was an engineer, so I could do a lot of math and I could do a lot of models. It was wonderful. But I didn't know how to navigate in the corporate environment, and it took some headaches, and it took some time. So, I would love to be able ,to do something like that for young professionals specifically. [00:23:12] Lindsey Dinneen: I love that. Well, I can sense a theme. Your heart is such a lovely heart of service and mentorship. So that is lovely. [00:23:18] Mildred Zayas: That is true. Yes, indeed. [00:23:20] Lindsey Dinneen: Yeah. Well, and sort of along those lines, how would you wish to be remembered after you leave this world? [00:23:27] Mildred Zayas: It's gonna be also very similar. I definitely wish to be remembered for guiding others toward reaching their full potential, especially those who face systemic challenges and for helping them create their own path to success. [00:23:43] Lindsey Dinneen: I love that so much, yeah. And then, final question, what is one thing that makes you smile every time you see or think about it? [00:23:52] Mildred Zayas: Well, you can probably guess this, but I'm telling you, seeing someone I've mentored or supported achieve their goals always make me smile. It reminds me of the difference we can make in each other's lives. [00:24:05] Lindsey Dinneen: Absolutely. That's just absolutely beautiful. Thank you for sharing that. So I am very excited to continue to watch your, how did you put it, portfolio career? [00:24:16] Mildred Zayas: That's what I'm trying to build. [00:24:18] Lindsey Dinneen: Okay. Unfold. So how can people maybe connect with you if they're interested in working with you as a supply chain executive or whatever else you plan to offer in this portfolio career of yours? [00:24:29] Mildred Zayas: They can follow me via LinkedIn. It's the best way. I'm there, Mildred Zayas. So, yeah, they can reach out. I'm happy to collaborate. I believe in teamwork, collaboration, and really helping each other succeed. [00:24:44] Lindsey Dinneen: Excellent. Excellent. Well, goodness gracious, this has been very wonderful. Thank you so much for spending some of your morning with us today, Mildred. Thank you for just sharing your advice and your heart for service and mentorship. And I'm so excited to see where this next step in your career takes you, so like I said, I will be rooting for you every step of the way. [00:25:04] Mildred Zayas: Thank you, Lindsey. I appreciate that. [00:25:07] Lindsey Dinneen: Of course. We are so honored to be making a donation on your behalf today to Feeding America, which works to end hunger in the United States by partnering with food banks, food pantries, and local food programs to bring food to people facing hunger, and also they advocate for policies that create long term solutions to hunger. So thank you so much for choosing that charity to support, and we just wish you the most continued success as you work to change lives for a better world. [00:25:37] Mildred Zayas: Thank you. Very nice. [00:25:40] Lindsey Dinneen: Yeah. And thank you also to all of our listeners for tuning in and if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two, and we'll catch you next time. [00:25:53] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Rick Sherak, CEO of Exokinetics, shares his incredible journey from serving as an Air Force officer to leading a company that develops transformative mobility devices. He discusses the importance of leadership, sales psychology, and creating compassionate company culture. Rick's passion shines through as he recounts heartwarming stories of how Exokinetics' Zeen device has profoundly improved the lives of people with mobility challenges, including children with cerebral palsy.   Guest links: https://gozeen.com/ | https://vimeo.com/1011399920 | https://vimeo.com/856975581/9994ad1cb8?share=copy Charity supported: Project ELEVATE Mobility Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 053 - Rick Sherak [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and I am so excited to introduce you to my guest today, Rick Sherak. After serving as an Air Force officer, Rick spent over 25 years in the medical diagnostic industry as a commercial and product development executive. Leveraging his broad leadership and medical domain experience, he became CEO of Exokinetics in March 2024 to lead the company into its next expansion phase of market awareness and revenue growth.  Alrighty. Well, welcome, Rick, to the show. Thank you so much for joining me today. I'm so excited to speak with you. [00:01:30] Rick Sherak: Well, it's nice to meet you, Lindsey, and I'm glad to speak with you today as well. Should be fun. [00:01:36] Lindsey Dinneen: Yeah. Excellent. Well, I would love if you would start by sharing a little bit about yourself and your background and what led you to MedTech. [00:01:45] Rick Sherak: Sure. Well, so I currently live just outside of Philadelphia with my wife and our four dogs. We just recently moved here from Boston, so we've had to quickly become Philadelphia Eagles fans. Go birds. We love it here. And my background is kind of interesting, a little bit diverse. I started off my career as an Air Force officer. I tried to follow my dad in his fighter pilot footsteps. Got almost there, but I had a medical disqualification, so I had to do a land based job, but really enjoyed the Air Force. It was a great way to pay for my college and to serve my country and also to learn leadership. It was like a masterclass in leadership. Talking about getting thrown into the leadership fire, and as a young 22 year old, lead a group of people on a mission, motivate everyone, and get everyone producing at their highest capacity. So that was a great way to start. But after I got out of the Air Force, I really wanted to go back to my roots, and that's in the sciences. I've always loved the sciences, especially the biological sciences. I have a degree in biological science from Baylor University. So out of the military, I was looking for an opportunity to use my interest in something that would support my family. So I started with Abbott Laboratories. And Abbott Laboratories, back in the day, was a Fortune 100 company, one of the up and coming medtech companies, had a pharmaceutical arm, but I belonged to the medical diagnostics side of it. And it was great. They, at the time, were hiring a bunch of ex military officers to be their field sales people and none of us knew how to sell. We were all out of either the Air Force, Army, Navy or Marines, but we learned quick. We understood, you know, there's the hill we have to take, but I really respected Abbott because they trained us not only how to sell, but how to sell with integrity, right? And they also, you know, they had 200 products that we had to learn and become masters at because we were selling to hospitals and medical laboratory clinicians, etcetera. But it was a great way to start my career, and I truly found that I loved it. One, I enjoyed the sales aspect. It was fun helping people solve problems with our products, and ultimately, help the patients get the best care right from their diagnostics. But two, it also taught me that I was pretty good at it. I did very well at Abbott. I promoted several times and won some national awards. And as a result, I was recruited away by another medtech company, which was a early stage organization called Ventana Medical Systems. I intended to be there for three years and learn everything I could and then expand my career. I was there for 15 years. And we had a ball. We took this little medical diagnostic company that came up with a transformative device that would automate very complicated processes in the pathology laboratory environment. So it was disruptive technology. We were going out there with something no one had ever seen before. And I joined them pre IPO. So we went public and then we started churning and burning and impressing Wall Street every quarter so that we can up our value. 15 short years later we sold the company to Roche Diagnostics. So what a great exit and just a wonderful experience and developing my leadership cause I was management as I quickly was filling levels as we were growing. But what a wonderful ride, that's something to see, somebody with an early vision to take it step by step to a wonderful exit. But we helped a lot of people, we became a market leader in immunohistochemistry automation, and it just truly was a great experience. But after Ventana, I wanted to do something a little different. So I stepped into the world of startups. I spent about 12 years in the startup world, worked for four startups, two of which died, which happens a lot in that environment. And then the other couple did pretty well. I really enjoyed it because now I was helping people on the oncology diagnostic side of medtech. So each startup had a unique laboratory technology that would better predict the patient outcome to a particular chemotherapy or targeted immunotherapy for their cancer. So, the whole purpose was to see how can we get better predictive value so that these patients don't have to suffer unnecessarily with the wrong drug. So that, again, was just a wonderful opportunity for me because more than not, I would come into these startups and have to create the commercial organization from scratch. That means I had to hire my own national sales team, my own marketing team, my own customer service team and logistics team to handle very delicate samples. But I loved it. It, it enabled me to take everything I learned from the air force, from Abbott, from Ventana and apply it to a small company environment. And I found that it was addictive, and that's why I stayed in it for many years. But then I did another turn and I took a sidestep because I loved also, has always been kind of a frustrated engineer. I joined an engineering company that just focused on design development of medical devices, and they hired me because of my diagnostic domain experience. And I went out and found early stage companies and brought them to this engineering firm so we could take the novel technologies from these companies and make them into a product that could be commercialized. So I did that for several years. Long story short today, I'm in a completely different type of medical device environment. I'm the CEO of Exokinetics, and Exokinetics is a very unique organization in that we decided to look at the mobility device market and fill the gap, because unfortunately people with mobility challenges are basically regulated to either wheelchairs or walkers or electronic scooters, all of which have significant problems to their health because they're not using their body in many cases. And fall prevalence-- people with walkers-- oh, it's just such a shame. There's over 50, 000 emergency room visits a year of people falling with their walkers. So anyways, Exokinetics has developed a very unique mobility device that gives people a lot more freedom. and safety in their daily challenges with mobility. So, sorry, it's kind of long. [00:08:44] Lindsey Dinneen: Oh, I loved it. No, I so appreciate it. Thank you for talking us through all of that. That was great. And so many questions, but I'll try to start at the end a little bit and then probably work my way back. But yeah, so, okay. So I'd love to hear more about the company that you are now involved in and this device. But I'd love to take it back a little bit further and say, what made you aware of this challenge existing that there isn't a great solution in the marketplace, or not maybe more updated options. So what made you aware of that challenge and then decide, "Okay, I think I have the tools, resources, ideas to fix it, to address it"? [00:09:25] Rick Sherak: It's a great question. I, one, I was not aware, right? I was not aware of the challenges. However, a buddy of mine, we go to the same church, you know, we're in a men's group, we're a bunch of old guys hanging out talking about stuff. And he was doing some investment investing into early stage or startup medical diagnostic companies. A very generous individual, and he knew of my background and he goes, "Rick," he goes, "I'm looking at this company. I'm not sure I want to invest, but maybe you can look at it with me." So I did some free consulting for him, he's my friend. And then he kept dragging me to this company to their board meetings. Right. And I'm going, "Hey, this is great," and I give him my advice because, because it was new for me. And that's how I found out, Lindsey, about the challenges that people with mobility issues have, is that the status quo now is, oh, you have Parkinson's, or you have cerebral palsy, or you've had a stroke. Put those people in a wheelchair and just let them live their life at that level. And I didn't realize how horrible that is for many of these people because they still have utility of their legs, right? But when you're confined to a wheelchair for long term, your legs will naturally atrophy, right? And become so weak that they won't be able to use them anymore. So what struck me, as mission driven, was that this company invented with their own engineers, this device that not only promotes people with mobility issues to use their body, but to use their body effectively moving around horizontally around the world, but also vertically. It enables them to go from a seated position to a standing position. And for us, for you and I, we're thinking, "Well, yeah that's pretty good." For them, that is a game changer being able to go from seated position to standing and then walk from that position all without the fear of falling. So, it really touched my heart as I learned more and more about the company and I kept giving more and more time to them. So eventually I was pulled aside and they said, "Rick, what's your appetite for running this company because we need to grow it and we need to get out there and help more people." So lo and behold, I've been here for almost a year. February 1st is my anniversary and it's been a great ride. I just love it. I have a passionate team, mostly of young people. I love it. I couldn't script better people, more compassionate, more caring. All of our customers are suffering in some way or another. Even our elderly customers that are just bad knees, bad hips, bad endurance, our device is perfect for them. So, yeah, you know, we're having fun. [00:12:27] Lindsey Dinneen: That's great. Well, yeah. Thanks for sharing a little bit about that too. And so, as you've stepped into this leadership role that you weren't necessarily anticipating was your next right thing, what were some of the challenges? Because you've had an amazing career, and like you've said at the beginning, you were learning leadership skills all throughout and you've had many iterations of different ways of approaching medtech, with the industry. But now as CEO, that's another thing. And so I'm curious, how was that transition to step into this leadership role and take it on? [00:13:03] Rick Sherak: No. And it has been different in many ways, but it's also very similar in others, right? Because in my opinion, leadership, really the definition from my perspective is that a good leader motivates effectively a group of people, talented people, and usually very diverse group of people, pulls them all together to accomplish an overall mission or goal, right? And it's it. That's the part I wouldn't say that's easy about my job now as a CEO, but it's natural and I love motivating my people. I'm a big fan of management by walking around and I try to talk to all my employees at least every day or every other day just to see what's going on, not only in the business side of things, but also in their personal side of things. I, I assume that nobody's going to respect me unless I earn it. And, I just wanna make sure that I'm leading by example and I'm the guy that either gets to the office first or leaves the office last, just trying to make sure that I'm there for my people when they need me. What is different, Lindsey, is that I am struggling with delegation because I want to do it all myself, right? And I know better. It takes me a long time to dye this hair white because I'm not that old, but just know better. But it's a struggle because you have to allow others to get things done and especially in a small company like this. We were still very early stage. People are wearing a lot of hats and I just have to allow them to go and give them the best guidance I can and then press on to the next thing, right? [00:14:49] Lindsey Dinneen: Absolutely. So, it sounds like you've been very intentional building a company culture that reflects the values that you care about, of course, and also reflects compassion, because you mentioned, your customers, for instance, are all folks that are in a difficult, challenging place. So how do you feel the importance blends from really intentionally cultivating a culture that is this empathic, creative problem solving, just really good culture, it sounds like, to how that affects how you basically present to the world who you are. [00:15:28] Rick Sherak: Yeah, well, no, that's a great question. So where our challenge is that our customer base is so broad, right? And like you said, all of our customers in our DTC business-- that's about 40 percent of our business is direct to consumer, right? But we have other customers, distributors. We have hospitals that use our device, physical therapy, occupational therapy, neurological research, you know, things like that. But the key, I think, from our perspective, is we want people to realize that, hey, we don't have 20 products, right, that we've gotten from other folks. We have designed and developed a very new and transformative device that only came about because we had our own internal engineers, and we've listened to what is needed out there to help people live a better, more free, more independent and active lifestyle. So, you know, interestingly, when we broadcast ourselves out there, I hope that people realize that, "Wow, this is not just a company selling something new, they design and develop this with their own people," right? There's a lot of love in our products, and people can tell because each one of our products is handmade, and it's customized to the individual ordering it by their weight, how much they weigh, and how tall they are, so we can adjust everything for them. And I tell you it's a lot of fun because some people literally take the time when they get their Zeen-- that's the name of our product, Zeen-- but they'll write us these wonderful notes on how this device has just transformed the way that they engage with their world. And, when you sit back and you go, "Hey, what difference are we making today?" Wow. That's why I think I have such a motivated group of people because every day we're talking to these wonderful, courageous individuals that have lost a big part of their ability to live effectively in the world and they're looking for something new, something meaningful and something that's going to help them. And when we can provide that it's just wonderful, very rewarding. [00:17:52] Lindsey Dinneen: Yeah. Yeah. Of course. Just to know the impact that you're making and able to make. And so the days that get really tough or frustrating or whatever, you can still hold onto this anchor of, "But we're making a difference. We know that." [00:18:07] Rick Sherak: And we see it. We have visitors come to the factory just about every week. Maybe two or three visitors will come and they'll try it out. Try out the Zeen to say, "Hey, I saw it on social media, just want to try it. You guys are local." And that's when we really get that, that visceral customer experience, right? It's just crazy, Lindsey. I've seen people come in, bent over sitting on this little electric scooter with a joystick. And they come in and they just look broken, right? And then we get them into a Zeen, and then they're all of a sudden their spine starting to straighten, right? They start sitting up, and then we slowly and compassionately show them how the device works and everything, but we make sure that they feel safe and that they trust. And as soon as we get that go ahead, which often you just see it in their eyes, then we'll engage the levers and the Zeen will lift that person with-- it's kind of like a big bicycle seat under them. It lifts up with this non motorized lift mechanism, that we invented, up to 75 percent of a person's body weight. So now they go from the seating position to standing. Now, many of these people can't do that on their own. They can't extend their legs from seating to standing. They need other people to grab them and lift them, right? But now Zeen lifts them. Now they're standing. And again, it's just phenomenal because this person that came in on this scooter bent over is now standing. They're putting weight on their legs. They're stimulating their brain because there's weight on their legs. Right now, neural connections are starting to flow again, and their spine straightens, and they stand tall, and when they take those first steps, often it's very slow, just tiny little steps. But then we just leave them be, and we talk to their family that came with them, and we go get something to drink, get some snacks, start chatting, and just let them be. And it's amazing, you can just see their brains working, and their legs moving faster and faster. I've seen people barely moving at the beginning, and at the end, they're cruising, we call it the lap, they go around the office, around all the desks and everything, and everybody's clapping, you know. It's amazing. [00:20:28] Lindsey Dinneen: Wow. [00:20:28] Rick Sherak: It's so cool! I'm not trying to overstate it, but this is our daily life. So I'm just very happy and pleased that my background has led me here. It's a great way to finish my career. I want to stay here for as long as I can. Hopefully it'll be many years because I enjoy every day of it. [00:20:52] Lindsey Dinneen: Wow. That's incredible. Yeah, and thank you for sharing those stories. I was just imagining that, that laugh and how amazing. [00:21:00] Rick Sherak: It is so cool. [00:21:03] Lindsey Dinneen: Can't possibly get old. Just witnessing joy and hope, honestly, even hope alone is... [00:21:10] Rick Sherak: One of the best is this father comes in with his twin boys. And the boys have cerebral palsy. It's a disease that you get from birth, right? And their legs are just not good. They have no balance at all. And the father brings them in. He carries them because they don't even have a mobility device that really works for them, except for walkers, like an old person walker, right? But he carries them in, he puts them on the, in the lobby, and we bring over the Zeens, and these little boys are the cutest things you've ever seen. They're just, they're twins, they're chatty, they're so excited. We get them into the device, and their first few steps, it's like I said before, we're just tiny, tiny. But then they built their trust. And at the end of the visit, these boys were running. I mean, they were digging in with their little legs, fully supported, fully trusting the device and their hands were in the air waving. And their dad is just like tears. He's just like gushing. He's going, "One, I've never seen my sons run before. Two, they've never moved without their hands either holding a walker or crawling on the floor." He goes, "These boys are running around with their hands in there in the air." And they're saying, "Hey, look, Daddy, my hands are in the air. I don't need to use my hands." Of course, we have Kleenex boxes all over the office. [00:22:36] Lindsey Dinneen: Yeah. I'm pretty sure you'd have to, it's just part of the the office supplies. [00:22:42] Rick Sherak: Exactly. Yeah. We have a Costco membership for regular shipment of Kleenex. Yeah. [00:22:49] Lindsey Dinneen: That's amazing. Oh, thank you so much for sharing that story. That's incredible... [00:22:53] Rick Sherak: Oh, yeah. [00:22:54] Lindsey Dinneen: ...just for a father's heart. [00:22:56] Rick Sherak: Oh, it's just so amazing. Yeah, it's so amazing. [00:23:00] Lindsey Dinneen: So this is all incredibly exciting just the way it is right now, but I imagine there are future plans. Can you share a little bit about what's next? What are you excited about as you move forward? [00:23:12] Rick Sherak: Well, what's really exciting is our growth potential, right? So again, the Zeen is a very unique device, but it fits so many different segments of populations. Like we've been talking about people with chronic illness. That is our core group, right? We work with people with Parkinson's, MS, muscular dystrophy, cerebral palsy, ataxia, you know, just about anything like that where people have strength, balance, or endurance issues. The other part that we're really excited about this year is that we didn't realize until those boys, how much our Zeen would help in the pediatric environment. So now we're making a very concerted effort going after the children's hospital physical therapy groups, showing them the amazing utility of a Zeen. And also because it's so adjustable, a person, a child can get into a Zeen early, let's say at the age of seven, and it could actually stay and grow with them until they're 14 or 15 years old. The whole thing adjusts up. So we're very excited about that market space. And we're also introducing the Zeen to luxury senior centers, because so many of our Zeen customers are just elderly people that don't want to give up, that have this incredible determination to either maintain or regain their mobility. Their knees hurt, their hips hurt, their endurance is down. So that's another avenue that we're introducing ourselves to, primarily through social media and publications through PR. But we're hoping this new awareness will get more Zeens out there. Our goal is really awareness. And that's one of the reasons that you and I are talking. I want to get out there as much as possible and let people know that there's other alternatives out there for their loved ones or for themselves if they have mobility challenges. And please check us out. We have a really cool website, a lot of videos, a lot of testimonials, and we just love helping people. And we're very fair in business. Our product is not cheap, but we give most customers a 14 day minimum home trial, and we say, "Use it a lot, as much as you can to make sure it's a good fit." If you don't like it, money back. So we try to be as fair as possible to make sure it's a good fit. [00:25:39] Lindsey Dinneen: Yeah, that sounds good. Yeah. And so for any of our listeners that are, you know, going to go and check out the website, just make sure you have your own stash of Kleenex. Oh man. [00:25:54] Rick Sherak: And every time we sell a Zeen, it comes with a virtual training session. So it's a one on one with one of my specialists. And I tell you, these folks are the best. So the best trainers and they're just the most delightful people, right? And they're like you. They're virtual, but you feel like they're right there with you. So we do virtual training for every one of our customers. And, it gives us that opportunity to see people eye to eye and to ensure that they understand their new tool and how to use it and how to, like I mentioned before, how to trust it, and realize that they're not going to fall, that they can move again, and they can do it safely. [00:26:34] Lindsey Dinneen: Amazing. Well, gosh, thank you so much for sharing about the company and... [00:26:38] Rick Sherak: Yeah. [00:26:39] Lindsey Dinneen: ...the device and the lives that it's impacting. And I just, I love learning about this. I'm so excited about the work that you're doing. So thank you for putting in the work. It's not easy. Startup world is difficult and especially medtech, but you've done it. So good job. [00:26:56] Rick Sherak: Well, and this is also interesting for me because it's manufacturing. Before, I didn't have to manage manufacturing. So manufacturing is a whole different beast with getting your parts, getting them ordered in time 'cause everything has to be built just right. This is like a high end super bike, you know, has the latest in technology for aluminum framing and engineering leverage. So that's a challenge for sure. But the other thing I wanted to plug real quick, Lindsey, if you don't mind, is again, we're a premium priced product, but we're not covered under insurance plans right now. That means Medicare or Medicaid. So, part of our outreach is we've created a foundation. It's a nonprofit foundation so that if we can find donors that want to support, the money goes into our foundation, and we take applicants and we provide grants for up to half the cost of a Zeen through the foundation. The other half is on the people that are trying to buy it. And, it's so interesting. Talking about putting skin in the game, right? People call and say, "Geez, I just can't swing that amount of money." Well, let's talk about the foundation, but you have to come up with half. And that creates such a-- it's such a partnership, and they're so excited. They'll be emailing my folks going, "Hey, I was able to raise 500 through a crowdfund! I just got to keep going!" And we're going, "Yeah, keep going!" And as soon as we hit that halfway mark, the foundation kicks in and covers it. So again, I just want to put a plug out there so that we can help very deserving people that just financially need a little support. Yeah. [00:28:37] Lindsey Dinneen: I love that. So that's a great way for even listeners to get involved, even if they don't necessarily personally need the device, but donating to this incredible cause, that would be awesome too. [00:28:48] Rick Sherak: Anything would be so appreciated. [00:28:50] Lindsey Dinneen: Great. Yes, absolutely. Well, okay. So pivoting the conversation a little bit just for fun. Imagine that you were to be offered a million dollars to teach a master class on anything you want. It can be within your industry currently, it could be about anything. What would you choose to teach? [00:29:13] Rick Sherak: You know, that's funny that you said that. I live right next to Villanova University, and a lot of my neighbors are professors there. And one of our best friends that lives a few houses down she's in the business ethics department. And she even said, she goes, "Rick, have you ever thought about teaching?" And I said, "You know, I've never really been a teacher." But if I were to teach, the thing I would love to do would be to capture over all these years of me being in this industry, the nuances of the psychology of sales. Because people think of sales as, "Oh, you're trying to trick people into buying, right?" Turn that completely upside down to, you're trying to assist people to buy. Because people really, when they're looking at your product, they want it. But they need help. They're counting on you to help them in that process. And it's a psychological bond when you're talking to somebody and you have a product and they have a need and you're trying to find that, that perfect combination, right? So that they feel, "Hey, this is great for me. It's worth every penny because I see the value." Versus having them feel, "Oh man, I'm going to get ripped off." So I would love to go down that path. I think that's so interesting because people are people, and salespeople, the best ones I've ever seen, like I mentioned before, are compassionate and caring, but they're also pleasantly persistent, right? And they just, they go, they listen and they say, "All right, but let's keep moving down the path." And people that are on the buying side truly want that. They want that partnership, that walking side by side down that path to purchase, because sometimes they're not courageous enough to buy just by themselves. So, to destigmatize sales would be kind of fun. [00:31:13] Lindsey Dinneen: I love that. That would be great. That'd be a great masterclass too, just to really dive into some of that, and yeah, to put a different perspective on your role and you're helping somebody to achieve what their goals are, to be honest. [00:31:26] Rick Sherak: Absolutely. [00:31:27] Lindsey Dinneen: I love that. [00:31:28] Rick Sherak: Absolutely. And we've all had those good experiences, and we've all had those bad experiences. [00:31:32] Lindsey Dinneen: Definitely. Definitely. So how do you wish to be remembered after you leave this world? [00:31:40] Rick Sherak: You know, that, that's interesting because I love to read. My morning time is my reading time. That's my time. It's me and my two collies. They're also early risers. The pugs, the two pugs, no, they'll sleep in with their mother. But in my reading and in my studies, essentially, I think it all boils down to at the end of the day, when the curtain starts coming down, wouldn't it be nice, when you're out, you're no longer here and people look back and they just say, "You know what? That guy or that lady really genuinely cared about other people." I think authenticity and being genuine is something I would love to be remembered for. And it's not easy, because sometimes you're not authentic to yourself, yet to others. [00:32:29] Lindsey Dinneen: Yeah. [00:32:32] Rick Sherak: But especially at this stage in my life, I just see caring for people is just amazing. Talking about, if everybody cared a little bit more for each other, it might be a different place. [00:32:43] Lindsey Dinneen: Yeah. And having the courage to be authentic and honest can sometimes also be, it does come with a little bit of vulnerability. So I love that. [00:32:55] Rick Sherak: Oh yeah. Oh my gosh. You know, it's all about, if you're just so lucky to have a little bit of grace, a little bit of wisdom, but like you said, a lot of courage. That's when it all means something, right? Cool. Oh. [00:33:10] Lindsey Dinneen: I know. What is one thing that makes you smile every time you see or think about it? [00:33:22] Rick Sherak: Well, you know, funny because we've been talking about leadership and sales. I just got to tell you a quick story because it always makes me smile. As I mentioned before, I was an Air Force officer and all of a sudden I jump out of the Air Force into a sales role with a medical diagnostic company. And, I just went through training. I got assigned to my territory. Baton Rouge, Louisiana. I'm a Colorado boy. So Baton Rouge, Louisiana was a little bit different for me, but the company moved me down there, and I started my sales career. And my, my customers were all hospitals and clinical laboratories in Baton Rouge, Lafayette, and the Bayou South, all those little towns in there. And I didn't realize it until after I started, but my territory was made out of the accounts the other sales people didn't want. [00:34:16] Lindsey Dinneen: Oh. [00:34:17] Rick Sherak: So the guys that were there, they cherry pick the good accounts, and the ones they didn't want, they made into my territory, right? The new guy. But I went in, I was dialed in. I had my brochures. I knew all my product knowledge. And I'd make appointments and I'd sit in front of these lab managers and these clinical influencers. And these lovely people, they would sit there. They would be so kind. They'd have their arms crossed. I go through my spiel and then they just look at me and they say, "Thank you, Rick, for coming. I'm not interested at this time." I go, "Okay." So this went on, Lindsey, for six months at every single hospital or clinical laboratory. I was like on the bottom of the sales list. I couldn't get anybody to buy anything. And it was like, it was so funny. And this is what makes me laugh. I'll never forget. I was down in south of Lafayette, and I was sitting in front of this lab manager and I've seen him every three weeks like clock work, right? And I'd always bring in new information, recap what we discussed before, and asked for the business. And he'd always say, "No, I'm not interested." But about six months in, he just looked at me and I got through my spiel. And he goes, "Rick," he goes, "Are you just going to keep showing up every three weeks?" And I said, "Yes, sir." And he says, "Look," and I mean, he's going, "Well, I'm not buying anything from you." And I said, "Yes, sir. But I, I truly feel that my products are the best products that you could use in your laboratory to make you more successful and to give your patients the best diagnostic information to help them fight their disease." Because it was mostly oncology focused. And he just looked at me and he goes, "You truly believe that?" I said, "Yes sir, I truly believe and I'm going to keep coming back until you believe." And he just sits back and he, I'll never forget this, he unfolded his arms, put his hands on the table and he goes, "Well, okay, then let me see what you got." And it was awesome. Lindsey, I swear there was like some underground communication channel because every hospital or clinical laboratory started listening to me after about six months. It was weird. And then another six months, I was on top of the sales rolls, and I had turned my territory around and we were just having a ball. But it was that persistence, it was just in the caring. I just cared. I was convinced my products were better, and he appreciated that. And, it, it was a fun, it makes me smile today because there's nothing like seeing somebody say, "Well, you know what, I trust you enough to listen to you now." [00:37:06] Lindsey Dinneen: Yeah. Wow, that's awesome. They really had to go through that know, like, and trust you cycle or a journey. [00:37:15] Rick Sherak: These are long term Louisianians. I'm coming in as an outsider, too. So that was, I had to prove myself. But they are the one most wonderful people. Before I got promoted out of that territory, I used to show up at least once every, maybe two months, per hospital with all these crawfish and a big old pot and a boiler and I would be out in the parking lot. I'd be boiling crawfish and I called the lab and I'd say, "Hey guys, I got crawfish!" And they go, "Oh, Rick has crawfish!" And they all come out and we'd all eat crawfish. That's how you do it in Louisiana. It was a good time. [00:37:54] Lindsey Dinneen: Very cool. Thank you. Thank you so much for sharing about that. And just in general, being so willing to share so much of your story. I really appreciate it. I loved getting an opportunity to learn about you and your background and your heart for MedTech, your heart for the people that you're serving. So thank you. I know days aren't always a walk in the park as much fun as I know you're having, but I know you have good days and bad days. So thank you again so much for joining me. [00:38:19] Rick Sherak: Thank you, Lindsey. [00:38:20] Lindsey Dinneen: And I just wish you the most continued success as you continue to work to change lives for a better world. And just also thanks to our listeners for tuning in. And if you're feeling as inspired as I am, I'd love it if you'd share this episode with a colleague or two and we'll catch you next time. [00:38:40] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Mike Knox is a standup comedian and the author of "Vivien's Rain." In this unique episode that reveals the perspective of a device end-user, Mike shares his personal journey into the MedTech field through the lens of his daughter's epilepsy and the life-saving (and life-giving!) impact of a vagus nerve stimulator. He discusses the challenges faced before discovering the device, the transformation in his daughter's life post-surgery, and his advocacy work. Mike also touches on the stigma surrounding epilepsy, the importance of compassion, and his career shift from law enforcement to comedy, using humor to inform and inspire others.    Guest links: www.MikeKnox.com   Charity supported: Save the Children Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 052 - Mike Knox [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and I am so excited to introduce you to my guest today, Mike Knox. Mike is a standup comedian and author of the book, "Vivien's Rain," about his daughter's epilepsy and the medical device that saved her life. He is a retired parole agent, and I am so excited that he is joining us today because he has a very unique take on the medical device field from a personal encounter. All right. Well, welcome, Mike. Thank you so much for being here. I'm so excited to speak with you. [00:01:27] Mike Knox: Thank you for having me. [00:01:29] Lindsey Dinneen: Yeah, of course. Well, you come to the medtech field and to medical devices in a very kind of unique pathway, and I'm very excited to dive into that. But before we do, would you mind just sharing a little bit about yourself, your background, and what you're doing today, what led you to today? [00:01:48] Mike Knox: Sure. I'm retired law enforcement and now I'm full time stand up comedian and an actor, much better than law enforcement. And I have a daughter who has epilepsy. She's 17 now. She started having seizures at the age of two. And by the age of eight, she got a vagus nerve stimulator, which basically saved her life. So it's a small implant that's like a -- I'm not supposed to say this-- but it's basically like a pacemaker, but for your brain. So it's a small generator that attaches onto your vagus nerve and sends impulses to interrupt your seizure. So she's now been seizure free for eight years. And I go basically go and I'm an ambassador for the company that makes this product. And I go and talk about this product, which is basically, I mean, it has saved my daughter's life. And not only that, but beyond that, it's allowed her to be get her life back basically because she was pretty much just a little zombie cause she was on so much medication at the time. So really for the past 15 years, it was just my wife and I living day to day as parents just trying, you know, in and out of the hospital with my daughter. So now she's in a great place and that affords me the time to go out and talk. [00:02:54] Lindsey Dinneen: Wow. That's incredible. Okay. So can we go back a little bit and talk about what life was like before this device, before you discovered this device, before all of the changes started happening for the better, but can you just paint a picture of what did daily life look like and how did that go? [00:03:13] Mike Knox: It was waiting for the seizure to happen. And most of them were at night, so it would usually be my wife and I taking turns watching my daughter all night long. And she'd be be on medication, but she'd have break breakthrough seizures. She would have partial seizures, but they would go into grand malls and we'd have to go always to the hospital because that's where the rescue medication was. And then it would be at the hospital, always confusion because they were the hospital that was local, wasn't really trained. And we kind of found out not a lot of hospitals, emergency rooms, were trained for seizures, which seizures have been around 2000 years. So there's a lot of misinformation, a lot of not really good education. And that's where I, as a parent thought, this stuff really needs to change. So that's what my wife and I did was, you know, started small talking to our hospital and just trying to get a policy in place where we could, you know, safely get my kid from here to the hospital. Then as time went by kind of technology caught up and we were able to have a rescue medication at home. But there were times where my daughter flatlined twice. So it was very scary. And it was just like living day to day because we we're in crisis mode and waiting for that next seizure to happen. It really did for us, was that seizure was stalking us, always waiting, we never knew when it was going to happen, kind of narrowed it down to that might be at night or coming out of her sleep when waking up, like on the way to school. But it really held you hostage. You weren't able to, we weren't able to go anywhere. You always had to think of where you were gonna go and plan things out. And your friends and family kind of abandoned you be just because they don't know what's going on. They don't understand what your family's going through. And I think a lot of parents see that also as, people just don't understand what it is you're going through when you have a medical problem. And so, when she did get this device that changed everything. And the number one thing that it did was it finally allowed our family to sleep, which we hadn't been doing for years. I mean, it was really same with my daughter. She wasn't able to sleep. So then she's not able to really concentrate at school. The school didn't understand, and they thought she was just being lazy rather than she has epilepsy. And so it's always there trying to advocate for your child. It's still doing that, still dealing with school things where I'm having to advocate for her. And that's just what you're doing as a parent is trying to do the best for your child. [00:05:24] Lindsey Dinneen: Yeah, absolutely. Oof. Yeah. Thank you for sharing more about that and painting a picture for us. And then, so in your research, in thinking, there's got to be something out there. I would imagine as a parent going, "There's got to be a solution. There's got to be something out there." Did that research eventually lead you to the company that you now help speak about and whatnot? [00:05:45] Mike Knox: Yes. And that was, and I always tell people this too, is don't rely 100 percent on the medical system, meet them halfway and do your research. Cause a lot of it is, it's what I realized is, just a lot of it is failure. It's constantly failing and failing. And we went to different doctors in different hospitals and the insurance would say that it doesn't cover this, but we kind of bypassed the insurance to get to where the doctor that we wanted to. It took us about five years to get a diagnosis, to find out what was happening, to find the right doctor cause there were a lot of horrible doctors. And then you have to understand that, because I never really was in and out of hospitals, and I never really understood what, what the policy, every hospital is different. Every doctor is different and different doctors don't know. We were going to doctors thinking that they knew what epilepsy was, and they didn't. They weren't going to say anything, but they were a primary doctor or they were a specialty doctor. They didn't know what epilepsy was. And so researching and finding out, and then we had read about VNS, Vegas Nerve Simulator. And our doctor at the time had said, "No, it won't work." Well, that wasn't true because it's worked. And a lot of it is the drive is pharmaceuticals and you're kind of experimenting. That one doctor, she was doing fine on one medication and he wanted to change it and that caused her to have all these crazy other seizures. And you got to let go of this kind of grudge that you have, and the kind of anger, which we did for a lot of medical, you kind of got to look positively at the ones who are helping you. I really found out that a lot of the nurses were a lot more helpful, where I always thought the doctor's the one that's going to have the knowledge. And a lot of it was the nurses that had the knowledge, not that the doctors don't, but there were more nurses that were more helpful. And I always, my number one thing was compassion. You as a parent coming in there wanting compassion for your kid. At least that's what I was looking for. [00:07:25] Lindsey Dinneen: Yeah. Yeah, and so okay, so you found this device or you found this technology and you go, "Okay I think maybe this could help my child. The doctor is a little skeptical, but we don't really know the reasons behind that. Maybe they just don't have the experience to understand how it could help. And there's new technology coming out all the time." But so, so that happened. And then what got you to a yes, where you could actually try this and see the impact that it could have for your daughter? [00:07:52] Mike Knox: A lot of it was desperation. We had left one doctor after just years there and kind of figuring out, he has no idea what he's doing, and we can never call him on that. Went to another doctor and what you're doing with epilepsy is you're trying to find out where the seizure is coming from. So they do an EEG, and so they're attaching all these leads to your head and we were in the hospital for eight days the first time. No seizure, you know, you're off the meds. They're trying to induce a seizure, nothing happened. So the new doctor said, "We've got to do the same thing again." It's just exhausting because you're like, "I don't want to put my kid through that." But you have to, so we went through another EEG, caught a seizure, saw that they were coming from three different ways. Cause we were first looking at brain surgery and then her seizure was coming through three different areas of the brain. So now you can't do that. And then that doctor showed us the Vegas Nerve Stimulator, which at the time we had just come to my daughter having this horrible seizure in the hospital. Her recovery was really bad at the time. So I was just overwhelmed with this doctor showing me this small device that looked like a silver dollar and it just was too unbelievable for me at the time, but I knew that we had to do something for my daughter because it was the last resort. We didn't really have we'd run out of all options. It had been years of hospitals and doctors and back and forth. And so really, to me, it was our only option. And It just seemed so unbelievable because it was such a small device and, I think a lot of it was, nobody else had ever talked about it before. And so I had to go back and like look and go, oh, at the time, it'd been around 20 years. And then I also looked at-- I mean, I was a horrible student-- but I looked mathematically at, "Wow, this percentage of-- it's not a cure, but she could have a life that's 80 percent better. Well, I got through college with all C's. I'll take those numbers." And so it was pretty much at the time it was a no brainer just because everything was just so horrible that it was just, it was-- another chance was given to us. We had run out of options. We didn't have any. [00:09:46] Lindsey Dinneen: Yeah, of course. So you take this risk and you go, "Well, you know, if it has the percentage potential of maybe it'll improve her life this drastically," it was worth the risk, I would imagine, from both your perspective and your daughter's perspective. And then, so you do this surgery, you've got this implant. Now what is life like these days? Can she travel? Can she do much more than she was able to do before? [00:10:11] Mike Knox: Life is great. I just want to talk about the surgery itself, was that was another fear. I didn't want to put my daughter through the surgery, how horrible it was. It was so easy. It was, we went in and out. It's an outpatient surgery. It took maybe about an hour. It was so simple and a lot of it was just me as a parent being afraid. I was so afraid of everything watching my kid go through so much that that's what I tell everybody now. It was so simple because she's on her second battery because it needs to be replaced. So the first one lasted almost about eight years. So she's on her second one. And the second time around was even simpler because now they've got, at the time we got ours, I think she was only the eighth, in Los Angeles that got it, so the protocol wasn't in place. Now the protocol is in place. So they'll kind of get you in and out real quick and they all kind of know what it is, where at the time when my daughter first had it they didn't know what it was, so a lot of strides have taken place and now the hospitals know exactly what to do. So it's very simple. Whereas, and I run into a lot of parents that are afraid to give that the surgery and kind of all the things that go along with the surgery. And it's so simple and you never, you don't really. Nobody really knows. Now her life is absolutely wonderful. I mean, she went from not being able to keep up in school to now. Shockingly is cause I was such a horrible student. Gets straight A's and she, I mean, to me, that's the amazing part of, I really saw this device propel her and she was learning, which she couldn't do before because she was having seizures and her You know, she couldn't think, she had brain fog, she had all these kind of things that we all kind of, kind of take for granted that we don't really know, but that's what I mean by she, when she was a zombie at the age of eight was that she just couldn't think because she was having so much brain activity from her seizures, and a lot of times she's having seizures you couldn't even see them just as a parent you would instinctively know, oh, this isn't good, I've got to get her out of these, you know, I've got to take her home or I've got to give her medication. You know, that was another fear of mine too, was that, you know, when she's at school or she's with, you know, I'd come to school a couple of times where she would, I'd had them at school, but the school wasn't aware I found her on the play yard. I found her in the classroom and the school just, none of the schools are equipped because they're by law, they don't have to be. And so what I love about the Vegas nerve simulator is it's her bodyguard. It's with her 24 hours a day. It's somebody watching over her and it allows her just to do the things that we all take for granted. And. You know, like she's able to go to school and I feel comfortable now that she's a teenager, which was another thing was growing up. I want her to have her independence. You know, and now I can feel comfortable where she doesn't text me through the day because she's just a teenager forgets that she has it. And that's the best part to me about it. [00:12:47] Lindsey Dinneen: Yeah, that's incredible. Wow. That's an amazing story. Thank you so much for sharing that. And I'm curious now. So you got to a point where you saw the incredible difference it made in your daughter's life and then of course your family's life. And you're obviously very passionate about this device itself and the company. So now you are helping to spread the word. Can you share more about your advocacy and your work for that? [00:13:11] Mike Knox: I just felt nobody was there to talk to me about it, and so if there's ever any parents or kids that are looking at it, and it's, again, it's just fear of the unknown. So I go and advocate and talk about this great device. I probably get four or five calls. Most people don't want to talk about it, but I probably get four or five calls a year from parents, then they just have all sorts of curious questions. Number one, "Is it going to hurt? Am I going to be able to," one kid asked me the other day, "Am I still going to be able to ski?" And I said, "You're probably going to be able to ski a lot better because you're going to be able to focus on that." And I just tell him basically my story, which going back to, because it's not a cure, you have to wait. And so in the beginning when she first got it, it was about six months of no seizures, which was great. But then she had about five, but the vagus nerve stimulator comes with a magnet. And you can swipe that over your chest and that'll stop the seizures most of the time. And so I saw that progressing. And so I was always kind of writing down stuff and seeing that progress. And it was really at the six month mark where we all slept through the night. And I said, "Oh wow, she's sleeping." She never slept through the night before. She was always a lot of insomnia and stomach pain and I'm just getting up through the night. So she slept like a good 12 hours. And I was like, "Oh wow, that's huge." That, beyond the seizures, is huge. And then there was a morning where she got up, dressed herself, which she could never do; made her lunch, which she never did; made her breakfast, ate breakfast. So while my wife and I were sleeping, she did all this stuff on her own, which she could never do. You always had to tell her, like you literally had to tell her, "Okay, it's time to get up out of the bed," and you'd have to tell her several times. It's not just being a kid. She just wasn't processing. Just like she couldn't process sarcasm or humor, which was very hard for me as a father 'cause I wanted to joke around with my kid. And then she put together this Lego set, read the directions, which she could never do before. So you can really see like, wow, the Vagus Nerve Simulator has got her basically mind on track and she's being able to focus, which she could never do before, always distracted about everything. And then on the way to school, driving her, she was joking with me, and you could see like that spark in her eye that I had seen when she was younger, but hadn't seen in a long, probably six years. And, so beyond the seizures I was like, "Oh wow, this is working." So it really doesn't matter if it's working 100 or not. Something is happening here, and it's for the betterment of my child. And that's what I run into also is, people want that quick fix. They want 100 percent. They just want a cure. That's not what this is, but it's a heck of a lot better than where she was eight years ago, almost 10 years now. That's another thing. It really flies by because she got her first one at the age of eight and then she got her next one at 16. And, that is another positive about it, because life kind of stands still when you're in this crisis from anything medical, and now she's just able to live her life and be a kid. And that's the amazing part about it. [00:15:54] Lindsey Dinneen: Yeah, absolutely. Thank you for sharing. You mentioned early on something that stood out to me is, it's often difficult, I think, when there's a medical diagnosis or some pressing medical issue. It makes it hard for people outside of the family to understand what's going on, and therefore they might feel uncomfortable, and they're not quite sure how to offer to help or to just be there for you. And I'm curious, since you experienced some of that loneliness and distance, going through this difficult time, as a parent and now as an advocate, is there just some general advice you might share with people who might be in a situation where they have a family member or friend struggling with something, but they're not quite sure how to be there for that person? [00:16:40] Mike Knox: Yeah. I think the easiest thing is send them a card and just let them know. 'Cause I think a lot of people are thinking, "Oh, just text, but I don't know what to text them. And I don't want to say like, 'If there's anything I could do,' cause there isn't anything I could do." And that's a lot when you have like with epilepsy, there isn't anything anybody could do. And then people, they're giving you bad advice because they see it on TV. Like I would always get advice about, "Have you tried smoking weed with your kid?" And I'm like, "She's two. Yeah, I'm not going to smoke weed with my kid." So that's why I say a card, because then you can think about what you're going to say, and what I think is nice is, send some food or something or send a gift card, because for my wife and I, we were at home all the time because we couldn't leave. And I think a lot of people didn't realize that. I could not go to the store because if I leave the house, she's going to then have a seizure and I'm not going to be there for the seizure. So it was debilitating because I'm having to watch her 24 hours a day and nobody else understood that. I just say a card so that people at least know you're thinking about them or something like that. And most people just don't do that. I mean, I think people are thinking that people are going to, I think you see on TV shows, people rally behind you or whatever. They don't. I mean, most people are living their life. And for you as the person that's sick or with the family that's sick, just know that the people still love you and they care about you. They're just doing their own thing, but so you have to then understand that and not be upset with them. I'm not upset with my family that just, my family and friends that just abandoned me, you know? And I think that's life also. It's like, you have to repeat yourself over and over again when you're sick or have a sick kid too, and you'll hear the same stuff like, "Oh, I didn't know your kid was sick," even though you told him a thousand times. You know, "I never knew she had epilepsy." And I just think that's human beings. I think you have to have the compassion for other people also. And that's just, I think you go through all those phases in the beginning. You're going through all that grief and regret and all that stuff. And you just have to kind of let it go. Because people don't know how to deal with it, nor did I as a parent. I had no idea. So I had that crash course in dealing with it. But I think we as a family came out the other side of it. So I am very thankful at the outcome. And all I have is gratitude for where we are now, very thankful that she's in a great place. [00:18:40] Lindsey Dinneen: Yeah. And now I'm a little curious. So coming back to you and your story and your career trajectory, which sounds like it's had some fun twists and turns in it over the years, but so how has this experience affected both your professional life when you were in law enforcement, and then now as a comedian, are you able to use some of that platform to help even sort of process and then maybe inspire or educate other people through that? [00:19:09] Mike Knox: Yeah, and I look at it like it's all like with my comedy. I use the epilepsy. It's not making fun of epilepsy. It's informing. And I have people that come up to me and talk to me. "Hey, I have epilepsy. I'm so glad you talked about this because there's such a stigma." And I meet so many people and I'm gonna do it again next week where they didn't want to come because they're afraid, they're getting bullied. They don't know how to talk about it. They don't know how to approach it. A lot of families look down on it. There is a huge stigma for some reason. They're embarrassed that their family member has it or their child or whatever it is. And I really think that starts with state laws. So there was a law that was just passed in California where the schools have to identify seizures and everybody needs to be trained and that passed. And that took about five years and I worked on that. And that's where it starts with trying to educate people and starting with that one on one, you going and talking about it. But I do believe that only laws are going to change things and change people's mind. There's a lot of fake seizure videos that are on YouTube, a lot on TikTok, under the guise of comedy. And I don't agree with that. I don't think it's comedy at all. It's not something that I do. And that's something that I try to educate people on also is, it's not funny. There's people that are dying from epilepsy. And so just getting out there and talking to people. When I get that information, I just write that down and categorize it and see where the problems are. And it all goes back to just misinformation and people not talking about it. And that goes back to the funding and how the world works. Can people make money out of this? That's the only way that they look at it. If I had tons of money, I think you could solve it a lot quicker. I just take it day by day, and who I can talk to, and who I can show compassion to, again, because I think that's what people are looking for. And people just want a voice. They want somebody to talk to and you, and listen to other people. You know, I, that's kind of how I approach it also is listening to other people's stories because they feel unheard. And I think that's important. And through my older jobs and this job. And I think all you can kind of do is laugh at it 'cause it gets so overwhelming and so crazy. And you can't force people to see the way that you see things. So you kind of just got to laugh at it. And I think that's, I think that's healing in a way, a lot of people also, and especially with comedy. I mean, people come there, they know why they're coming there. They're coming there to laugh. A lot of it is they're coming from their horrible life, coming there for an hour or two to get away from it all. So I think it is beneficial to a lot of people. [00:21:27] Lindsey Dinneen: Yeah, absolutely. So what is your hope for the future or your excitement for the future as things continue to progress and more awareness is in place, more legislation to help with responses to this kind of situation? What are you looking forward to or potentially excited about? [00:21:46] Mike Knox: So I just look forward to a day where I don't have to do this anymore. Not going to happen, but I do see a lot of great technology and I see a lot of great strides within the last five to 10 years in the medical field with medical devices. And that's what I hope for. I hope for something, like with the vagus nerve stimulator, they're looking at having a rechargeable battery or not having to replace the battery. And that's what I hope for. And I hope for, that I never have to hear anything about seizures or epilepsy. I know that's not gonna happen, but for my daughter and everybody else I would love to find a cure for it. And anybody that has to deal with any kind of medical device, hopefully, you know, we can put more funding into it and have more cures. And I think we are at a great time for so much success in, I mean, we're living longer, we're living better. These next couple of generations are, I mean, my mom's 88. People are living a lot longer and a lot healthier, and so I guess if I have to be positive, that's what I'm positive about. [00:22:41] Lindsey Dinneen: Yeah. Well, that's good. That's taking the challenge with the opportunity and saying, "Okay, let's see what happens from it." So, you know, it's a step in the right direction for sure. All right. So, pivoting the conversation just for fun. Imagine that you were to be offered a million dollars to teach a masterclass on anything you want. It could be something that you've been working on from your career so far, so a skill set you've developed over time, but it could be completely unrelated. What would you choose to teach and why? [00:23:13] Mike Knox: It would have to be comedy because I've done so much comedy for free. I think that I can understand to teach that to other people and to tell them kind of all the traps of comedy. And it is just, comedy is consistency. It's getting your, you know, five minutes is really four minutes 'cause you're going to have about a minute of laughter if you're funny or not, but getting consistent and embracing the failure of it. And to me, those are the components of comedy because you've got to stand up there. A lot of it is you got to stand up there and embrace the darkness of being up on stage, which a lot of people don't want to do. And then you've got your material and you've got to be able to care. You've got to get new material and carry that material. So if you can, what I've seen, if you can get past that first five minutes and get 10 minutes and 15 minutes and so on, you're going to be okay. And so if I were to get a million dollars, I think that's the masterclass that I could teach. [00:24:00] Lindsey Dinneen: I love it. I love it. Okay. Awesome. And how do you wish to be remembered after you leave this world? [00:24:07] Mike Knox: To me, it's just that I did good. I think that to me, that's important. Do good and be good. ' Cause we see so much negativity all the time and we see so many people that it's like, you know, "Oh, I scammed this person out of that, but they deserved it." And there's kind of like no moral compass. So, when I was a, when I worked in law enforcement before, you know, people that you didn't even think that you touched their lives at all would say, "Hey, thank you. You made me recognize something different." And I think that's what life is all about. You've changed somebody's life or done some sort of kindness. It doesn't even matter. I think that's what a lot of it is these little things in life where you didn't even know that you did something to somebody. And it's that spider web of life where you your life intertwined with somebody. You weren't even aware of what you did but that impacted that person's life so much. And I think that's what we're here for is you're always trying to help other people. I mean, that's the whole point. [00:24:59] Lindsey Dinneen: Yeah, I agree. Yeah. Okay. And then final question. What is one thing that makes you smile every time you see or think about it? [00:25:08] Mike Knox: Definitely seeing the vagus nerve simulator working; anything with my daughter. I think being in crisis for so long, and just like yesterday, my daughter made cinnamon rolls. She likes to bake. So watching her make something from scratch and then having her happy and excited that she made something-- that, that to me is happy. Well, that always makes me smile. So it is those little things that always make me smile. [00:25:35] Lindsey Dinneen: I love that. Excellent. Well, this has been an incredible conversation. Mike, thank you so much for being here. I really appreciate your time and I really appreciate your commitment to sharing the word and being a positive helper in this situation. So if folks would want to get in contact with you, maybe because they have some questions or whatnot, or they want to follow your work, how could they do that? [00:25:59] Mike Knox: Sure. On all platforms, I'm Mike Knox, at Mike Knox comedy, or I have a website at mikeknox. com. [00:26:05] Lindsey Dinneen: Perfect. Excellent. Well, thank you so much again for your time today. We are so honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational, and safe environment. So thank you so much for choosing that charity to support, and also thank you for continuing to work to change lives for a better world. [00:26:35] Mike Knox: Thank you so much for having me. [00:26:38] Lindsey Dinneen: Of course, absolutely. And thank you also to our listeners for tuning in. And if you're feeling as inspired as I am at the moment, I would love if you would share this episode with a colleague or two, and we will catch you next time. [00:26:53] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development. And we just wish you the most continued success as you work to change lives for a better world.

Kelley Satoski is the co-founder and CEO of Pelva Health, a pelvic health startup dedicated to making intimacy pain-free for women suffering from chronic vaginal and vulvar pain. Kelley shares her personal journey with vaginismus, which led her and her husband to seek innovative solutions where none existed. They discuss the staggering statistics of women affected by this pain, Pelva Health's progress, and the significance of addressing women's health issues head-on. Listen as Kelley talks about the challenges and triumphs of starting a medtech company, the importance of curiosity and bravery in leadership, and the profound impact Pelva Health aims to make.   Guest links: https://www.pelvahealth.com | https://www.linkedin.com/in/kelleysatoski/; | https://www.linkedin.com/in/douglassatoski/ Charity supported: https://www.savethechildren.org/ Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 051 - Kelley Satoski [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey. And I am so excited to introduce you to my guest today, Kelley Satoski. Kelley is the co founder and CEO of Pelva Health, a pelvic health startup on a mission to make intimacy pain free for women with chronic vaginal and vulvar pain.  All right. Well, welcome, Kelley, to the show. I'm so excited that you are here today. [00:01:18] Kelley Satoski: Yeah, this is amazing. I'm excited to chat. [00:01:21] Lindsey Dinneen: Yeah. Wonderful. Well, would you mind just starting by telling us a little bit about yourself and your background and what led you to MedTech? [00:01:29] Kelley Satoski: Yeah. So, we were talking before the show about you being in dance and all your different ventures. I also have a similar background in the arts, so I didn't really anticipate starting a medtech company. That was probably the furthest thing from my mind. But I did grow up in a very entrepreneurial family. So I went to school for art and design, wanted to do my own thing, wanted to start my own startup. So I feel like that was always something in the back of my mind. But we started this pelvic health company because me and my husband, Doug, had a condition called vaginismus, which basically is a problem that keeps people from being able to have sex due to chronic vaginal and vulvar pain. And so we struggled with that for about 10 years and then after seeking treatment for five years, not seeing any relief, we decided, "Okay. There has to be a better solution." And so that was really the catalyst for starting Pelva Health and for getting into medtech. And we're the perfect duo for it. My husband's a biomedical engineer, has worked in many companies, has worked at biomaterials before, and then me with my background in art design, entrepreneurial spirit, and really fits us really well. So we're excited to be a part of the community. [00:02:57] Lindsey Dinneen: Oh, that is exciting. Wonderful. Thank you for sharing a little bit about the background. So that just sparks so many questions and I love the fact that you two have both sort of, you've got the creative side, you've got the business sense, you've kind of married them together. So tell me a little bit about what was this journey like for you of going through this really painful, difficult, experience and frustrating. I can only imagine probably spending a lot of money on trying to find solutions, not finding the answers that you're seeking. So how did you go from, "Gosh, this can't just be us. Other people have to be dealing with this too," to "Let's figure out the solution," because that's, that's a huge leap. [00:03:37] Kelley Satoski: Yeah, definitely. People are always surprised that 75 percent of women have pain with sex. 75 percent. And nearly 30 percent will struggle chronically over six months. In fact, most will suffer two to seven and a half years without relief. These are massive numbers. This is huge groups of people, and this is not just affecting women. This is affecting couples. This is affecting, like you mentioned, finances. I spent over ten thousand dollars in out of pocket treatment for these conditions. I saw over five providers. And then the impact really for me, the worst impact, is the one that it can have on your mental health, on the mental health of your partner, and your guys' intimacy in your relationship. It gets you fired up because it's such a complex issue that doesn't have a lot of research around it, does not have a lot of innovation around it. So something that really catapults us into trying to innovate in this space was personally a lot of dissatisfaction with the options I had. So, you know, for women with vaginismus specifically, one of the most common prescribed therapies is called dilator therapy. So it's basically a bunch of dilators that are of different sizes, and you basically do exposure therapy to stretch the vaginal canal, improve elasticity, and also to try to get over the psychological fear around the pain that you experience with sex. But it's got incredibly low compliance rates. We're talking like 75 percent of women won't comply because of the emotional turmoil, the amount of commitment that's required, the slow results that they see, and often a lack of translation to sexual intimacy. [00:05:38] Lindsey Dinneen: Mm hmm. [00:05:40] Kelley Satoski: And so part of me was frustrated with, you know, there's a lot of companies and it's good that we improve dilators, but to me, if women can't comply to something, or if a user can't comply, or if it's emotionally exhausting, and it's causing these problems, then we need to think of a different solution, like surely something better exists. And so it was important to that us that we didn't just create a better dilator. [00:06:12] Lindsey Dinneen: Mm hmm. [00:06:12] Kelley Satoski: We wanted to figure out, "Okay, how can we prevent pain immediately? What could we create to give people relief so that tomorrow they can go out and enjoy intimacy in the way that they want without pain. Tomorrow, not in six months after therapy, like tomorrow." So that's what we have set out to do. And just from that personal experience is really what catapults us into doing this startup. [00:06:39] Lindsey Dinneen: Wow. Wow. Amazing. Oh my goodness. Thank you for sharing the statistics too. I mean, that is, yeah, I think what's, what's crazy is there are so many of these kinds of stories that are emerging more and more, especially for women, of oh, wow-- so many of us are affected by these things and there just hasn't been the research or the money or time, who knows, devoted to it. So, you know, kudos to you and your husband for starting this company and trying to solve something, but also to your point of Not just, you know, six months, one year, whatever down the line. But hey, let's, let's actually solve this tomorrow. So as you've started in on this amazing adventure, which I'm sure has your, you know, shares of entrepreneurial ups and downs... [00:07:24] Kelley Satoski: Oh, sure. [00:07:25] Lindsey Dinneen: ...What are some of the exciting milestones that you've achieved so far and what are you looking forward to? [00:07:30] Kelley Satoski: Oh, yes, so many good things. We're an early startup, right? So we've done some proof of concept studies with some really incredible results. We are heading into a pilot study at the Center for Vulvovaginal Disorders with 10 women with provoked vestibulodynia, which is another term for basically having some pain around the entrance of the vagina with any sort of penetration. So getting some of that real data and feedback and seeing that we are actually creating something that is helping is really exciting. So I'd say that's the biggest milestone that I'm most excited about. [00:08:09] Lindsey Dinneen: Of course. Well, and proof of concept is such a great thing to, to really go, "Okay, yes, here we are. We can go ahead and get this going." So yeah. So, okay. So then you're going to do this pilot study with these 10 women. And then after you get the results of that, what happens next in this journey? [00:08:27] Kelley Satoski: Yes. So hopefully that pilot data helps inform, "Do we need to make any more design changes? Is there anything else we need to be considering before we fully lock the design? You know, don't make any more changes. This is what's going to market" type of thing. And then start preparing for FDA approval 'cause we are going through the FDA. There's so many wellness... you can't see my, I'm doing quotation marks, "wellness," "vaginal wellness" products that exist on the market, that you would be shocked by the amount of products that are on the market but did not go through the FDA. But we really do want to give women a product that's done the work, that's done the safety testing, that's done the clinical data, that's really has efficacy behind it so that we give women the best. That matters to me a lot. So we're going to go through FDA approval and then it'll be market launch. Once the FDA says "Yes," which hopefully they will. [00:09:28] Lindsey Dinneen: Of course. Yes. Rooting for , . Absolutely. So, okay, that is so exciting. So, so backing up a little bit when you first started this, I know you've, you've had this entrepreneurial sort of background and mindset to begin with, but the actual reality of starting a business is definitely still a learning curve, no matter how prepared you feel like you might be. [00:09:50] Kelley Satoski: Yep. [00:09:51] Lindsey Dinneen: So I'd love to hear about your experience as an entrepreneur and leading a company. And in, you know, going from here's this, here's this idea and now let's make it happen. So how, how was that transition for you personally as a leader? [00:10:06] Kelley Satoski: Oh, man. Yes, definitely starting one, an FDA regulated device company, and two, a startup that typically raises venture capital funds. So there's certain things that come with, that are a little bit different maybe than some other types of startups that exist, is definitely a learning curve. And so when we first started Pelva, we were so fortunate to be connected to the Purdue University. That's where my husband went to school. And so they have a whole program for alumni to basically join their incubator and learn all the basics of startup. And they don't take equity. They don't do anything with your IP. It's like purely to help support alumni startups in the Purdue ecosystem. So that was the most transformative experience for me, because it just thrusts you into the basics of doing a startup, of doing a medtech startup, of doing customer discovery, and all that's required of that, and then surrounding myself with so many incredible advisors, mentors. I'm a firm believer you can't do it by yourself. And so, you know, I'd rather be one of those people that just jumps in and then knows that I have people to support me rather than waiting till I have it all just perfect before I go. And I couldn't do it without that support system and those people that helped us in the beginning, so helpful. [00:11:34] Lindsey Dinneen: Yeah, that's great. And getting to learn from people who've been there, done that, and have that perspective and just even the experience of, "Oh, here's a couple things to watch out for" or whatnot can, yeah, make such a difference. And then, you know, you have had such an interesting career, also. You know, you haven't just been-- not that it's 'just' at all, you are quite the entrepreneurial leader now as well-- but in the past you've also had a really interesting trajectory, so I'm just curious, can you tell us a little bit about even your, your career before this and maybe how it's helped influence what you're doing now? [00:12:11] Kelley Satoski: Yeah. That's-- oh man, I've done quite a few things. So I went to art school and I worked with different nonprofits and businesses, did some freelance work for a while, and that was helpful. I'm really used to a blank canvas and making something out of nothing. And that's like quite literally what we do is like, "Okay, there's nothing here. What are we going to do? We just got to start." And so I'm used to that, that overwhelming feeling where it just feels like so much, but you just have to jump in. And I think that's something that I've carried with me from that time is just making something out of nothing, thinking about things outside the box. I think so often we get, you know, so in our little boxes and ways that things have to be done, and I feel like that's very limiting most of the time. Sometimes it's good, but most of the time I think we could all do a little dose of new perspective and seeing things from maybe a different view. So that, that's a very applicable part of what I learned there. Then after I sought treatment for about three years, I started to feel the itch and this was, we were thinking about starting Pelva, but I, you know, we weren't fully in or anything like that, but I was like, I need to interface with more people that are struggling with this. I'm starting to get interested in women's health because of this problem. So I actually quit the work I was doing and I became a postpartum doula and I started taking patient intakes at a pelvic pain clinic in Atlanta, Georgia for about a year. And so this is right before Pelva actually, I went to Pelva full time. So I probably interfaced and took intakes of over 400 women with chronic pelvic pain and different vulva vaginal disorders for about a year prior to pelvis, which I say too was like a super. Incredible way to get a foundation of customer discovery before, before you start a company is to go talk to 400 patients day in and day out. So I also say that was super impactful to really immerse myself around people that are struggling and need a better solution. [00:14:28] Lindsey Dinneen: Yeah, absolutely. And I love how different things from our past can really translate eventually, and I'm curious for other people, actually, you have such a unique and great perspective. So, so maybe for other people who have the spark of an idea for something like a medical device, but just, you know, maybe they're not from the industry or they would feel like that's just such a huge next step. What are some pieces of advice you might have for somebody? [00:14:57] Kelley Satoski: That's a great question. It takes a certain personality. I feel like I'm not super risk averse, I guess you should say it, in a good way, I think. I think the biggest thing I see people hold up on is "I don't have all the exact perfect experience. I need to go and be a manager of people for five more years before I'm comfortable being a CEO of a startup." And to me, that feels more limiting than expansive. And I think a better perspective is to, sometimes you just have to jump and just, what you can do is make sure you have people around you to carry you through and to help support in areas that you will need help. You will need help. And so I feel like that's what we did is just the very beginning, "Okay, where can we get mentorship, what other femtech, what other medtech leaders exist in the place that we live, we should connect with them, we should tell them our idea and get their feedback. And then you create this support system that actually makes it easier to step into a space that is new for you because you have support. I'd say that's like the way to go. [00:16:13] Lindsey Dinneen: I really like that. That's great advice. And I think there's actually kind of a correlation because I was curious, I was looking through your LinkedIn profile just for fun. I always like to kind of see what the guests are up to. And one thing that piqued my curiosity was actually your article that you wrote at one point that was replacing fear with curiosity. And there was a beautiful short little article about some ideas for how to do that. And I'm actually curious if you could speak a little to that because I think this is the exact right scenario to apply it to, is maybe somebody who's nervous and feeling overwhelmed by the idea, maybe we replace that with curiosity and see where that leads us. So, but I'd, I'd love your take on it since this is your thing. Yeah. [00:16:55] Kelley Satoski: I was so wise back then. I think I wrote that article like back in 2020 or something. But no, it is, I wrote that at a time where I had just graduated from college and I was in the arts, right? We talked about this, "Oh, getting a career in the arts. It's tough. It's full of unknowns. It's really competitive and competitive for very little pay. And so there's all of these strings attached." And I was just, yeah, feeling pretty insecure about like, I want to have impact. I want to feel like I have purpose. And I want to do all these things, but it's all very unclear and very scary. And having to say yes to different opportunities that like we said, sometimes feel like they are outside of our realm of expertise or comfort. And I feel like when we can approach things more from a place of curiosity and less out of this quick, reactive state, we can better move through that fear a little bit more, you know? Instead of being like, "Oh, I don't have enough experience," or "I don't do that," or "That was never on my game plan," or " "That's too risky, that's gonna fail," or "Nobody has created a better solution for vaginismus, there's no other solution, so what you guys have put out there, that's not going to work." Or, "No one has made a hydrogel like that. So that's not going to work." And so I'd be a little more curious about where do these limiting beliefs come from? And are they as set in stone as everyone makes them out to be? Or can we be curious about this? And actually, maybe they aren't so hard and fast as we thought at first. [00:18:44] Lindsey Dinneen: I love that. Yeah. Thank you for sharing about that. What I love about the idea behind curiosity, too, is that it helps because if you're in a place where you're really concerned about trying something new and failing, 'cause that's such a common, shared experience for so many people-- so if, if you're in that boat, but you treat it as " I'm going to explore this next thing as an exploration," then failure is not even part of an exploration, right? You're just exploring. You're just curious. So you're going to learn. And hey, if you find out that this isn't for me, you go on, next thing. [00:19:19] Kelley Satoski: I love that. Exactly. Yeah. And I always say to, you know, entrepreneurship and doing a startup and MedTech is not for everyone, absolutely not. But for those that I guess have the itch-- and I feel like you can usually tell who those people are-- I always, this is a quote actually from my husband, not me, but we always talk about "what's the greater risk?"  The greater risk for us is never going after a greater dream, never doing the things that we want to do, never pushing and going after. The greater risk is comfort, the staying in what we feel is the comfort zone, but never going after. That's the greatest risk. And so if you can reframe what's risky for you-- is going after your dreams really the greatest risk? Or is the risk that you never go after your dreams? That's, that seems pretty scary to me. [00:20:12] Lindsey Dinneen: Yes. Yes. Wow. That is really powerful. I love that. That's such a great question to ask yourself too, because to your point, sometimes it just feels like the risk is this one thing. Like, you know, it's just this one idea you have or the dream you have. It's not a comparison. I love the comparison. "What's the greater risk?" Oh my goodness. That's fantastic. I'm going to hold on to that one.  Wonderful. So, you know, okay, well, as you've been going along this journey and you've been talking with these women and other folks that have a shared experience or similar experience to yours, and you're creating this innovative solution, are there any moments that stand out that just really confirmed to you, "Hey, I am, I am in the right industry at the right time, doing the right thing." [00:20:58] Kelley Satoski: All the time. It's always a thing, you know, as a startup, like talk to your customers, talk to your customers, never stop talking to your customers. But for me, I love talking to customers because it continually, day in day out, reminds me why we're doing this. I had one person literally say to me, "This is the first time I felt hope in 10 years." I've had women that have gotten, been divorced over vaginismus, over an inability to experience intercourse, couples on the rocks, tears, you know, like the whole thing. The just feeling hopeless, I think is a really common theme from the women I talk to. And in fact, we had feedback groups for our product. And, I was like, "Okay, guys we'll keep you in the loop. We might be doing some clinical trials, studies in the future." And it's not even been a month and I already have people messaging me, "When's the clinic? I want to be a part of it. So just making sure that you're still doing it." So it's so confirmed, the prevalence. And I mentioned the statistics, but the other thing that always confirms to me that this is a real issue is almost every space that I pitch Pelva or talk about Pelva, I always have at least two people, men and women, that talk to me afterwards and talk about what they're experiencing with it, which really lines up with the, you know, the statistics on how many people are struggling. So, it's, yeah, it's a really big problem. [00:22:34] Lindsey Dinneen: But knowing that you're making an impact and a difference and inspiring hope in folks who don't have that right now, that's amazing. Yeah. What a gift. [00:22:43] Kelley Satoski: It is. Yep. And women's health is all the rage right now. So it is like you said, is this a good time? This is a fantastic time. This is, there is no better time, I think, to innovate in women's health right now. [00:22:56] Lindsey Dinneen: Yeah, exactly. Absolutely. Yeah. So, okay, so pivoting the conversation a little bit just for fun. Imagine that you were to be offered a million dollars to teach a masterclass on anything you want. It can be within your industries, which you have several, or it could be something completely different. What would you choose to teach? [00:23:16] Kelley Satoski: Oh, I feel like, if we were gonna keep this related to Pelva, I would hand that million dollars to my medical team and we'd put out this massive broadcast educating everyone about women's gynecologic health and educate on our anatomy and all of that stuff. I'd put a broadcast out there for everybody. That's very cheeky, but, and related Pelva, but, you know what? Hey, it's a million bucks. You gotta do something. [00:23:53] Lindsey Dinneen: Very good. Yeah. And it would be helpful because gosh, like we've talked about earlier, I mean, I had no idea the staggering statistics and I'm sure many of us really don't. So just, just having that awareness and that education and, what do we do next, and how can we help? And that's awesome. Well, also, how do you wish to be remembered after you leave this world? [00:24:18] Kelley Satoski: My goodness, going deep. But no, I love it. It's an interesting question. I, I want to be remembered for being someone that really went after things and was somebody that also really encouraged people to do what they want to and made that possible. I love big dreamers. So big dreams, always went after it, and was honest, a really honest person, really real, and kind. Those things, you know, good qualities. But yeah, I think a go getter was, is the first thing that popped into my head. So maybe that's the one I should go with. [00:25:05] Lindsey Dinneen: Yeah. I love that. And you know, the way you answered that actually brought to mind, I, I had a question I meant to ask earlier, was it difficult for, for you and, and, or maybe your husband as you're forming this company and you're talking about a very personal, your own story, what was that experience like? Was that really hard to get comfortable and used to talking? I just... [00:25:30] Kelley Satoski: Oh yeah! I lead every pitch that I do telling my story. I say it really quick, "I spent over 10 years unable to have intercourse with my husband due to a chronic vulvovaginal pain disorder. And as crazy as that sounds, here's the statistics." I've got it down to, I've got it down line by line. 'Cause it is tricky, it's tricky to talk about in such a way that others are comfortable. How do I share it in a way that doesn't objectify myself and lose people when I'm trying to really pitch a real company? So it definitely felt like a bit of an art on sharing. [00:26:07] Lindsey Dinneen: Yeah. [00:26:08] Kelley Satoski: I'm learning how to share my story, but I do remember at the very beginning, I hadn't told really anyone that I was struggling with this, not my family not, yeah, like no one. And I remember telling Doug when we decided to start Pelva, "Am I going to have to start telling people about this? If we're going to start this company, I'm going to have to tell my parents, I'm going to have to like, we're putting this out there." And he's like, "Yeah!" And I bet I just had to make the choice that it was worth it. But the more I talk about it, the more other people talk about their experience. And it ends up actually feeling really good. You end up starting to get more experience as you feel more, more supported and less alone. In fact, sometimes I wish people would not tell me so much, but they do! Talking to you, to my mother in law, too much info. [00:27:01] Lindsey Dinneen: Mm mm. Oh, man. [00:27:03] Kelley Satoski: Yeah, you get to create these really safe spaces for people to also share what they're going through. We need to talk about it. [00:27:11] Lindsey Dinneen: It's so true. I definitely commend you for that. Because yeah, that that would certainly be uncomfortable for a while, maybe, maybe forever. I don't know. But, you know, being able and willing to share and be vulnerable to your point, I think, is what creates that safe space for other people to say, "Oh my gosh, me too." And, "How, how can we change this? How can we band together or at least support each other?" So I love that. Thank you for creating those safe spaces. [00:27:36] Kelley Satoski: Yeah, and I feel like, and the other thing that I would say is that, I always got a lot of like, "Ooh, be careful, you're going to run into a ton of pushback and people are going to be weird." And something I feel like I've decided really early on is to give people the benefit of the doubt. I think, yeah, sex is hard to talk about, like, it is, you know, and I'm not gonna blame anybody for feeling a little uncomfortable talking about it, and talking about me and hearing those really personal stories. So I think the more I've approached it from just a very accepting and less reactive and looking for people to be weird about it, or not accepting or not supportive, whatever that energy you project, you almost start to receive. So I've tried to be a little bit more open about it all. [00:28:29] Lindsey Dinneen: I love that. Yeah, that's fantastic. Thank you. So, final question. What is one thing that makes you smile every time you see or think about it? [00:28:40] Kelley Satoski: Oh. Oh, man, that is an interesting question, but I like it. I would say I was a part of this Herb Society in Minnesota here, the Minnesota Herb Society, and it's full of the most lovely old ladies, and I am the youngest person there, for sure, but they are the most wonderful ladies and the most joyful people to ever be around, so I think whenever I think about them, they make me smile. There's a bunch of old ladies digging in the dirt and planting herbs, what can't you smile about? [00:29:16] Lindsey Dinneen: Yeah, what's not to love? That's phenomenal. I love it. So cool. Well, oh my goodness, this has been an amazing conversation. And Kelley, just thank you so much for for sharing and for being willing to take the risks, right? And and to, to compare risks and say, "The greater risk is doing nothing or or not chasing after this. And we don't know where it's going to leave, but we're going to try." So... [00:29:40] Kelley Satoski: Yes. [00:29:41] Lindsey Dinneen: ...Thank you for doing that work. I know it's not hard. There are probably days where you're just like, "What did I do?" But you're doing it. So thank you for bringing this to the world and being open and vulnerable and, and letting other people be too. I appreciate that. [00:29:54] Kelley Satoski: Of course, I appreciate the opportunity. [00:29:56] Lindsey Dinneen: Yeah! And we are so honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational, and safe environment. So thank you so much for choosing that charity to support. We just wish you the most continued success as you work to change lives for a better world. And thanks again for being here today and sharing your expertise with us. And thank you to all of our listeners for tuning in. And if you're feeling as inspired as I am, I would love it if you would share this episode with a colleague or two, and we'll catch you next time. [00:30:41] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Aaron Burnett, founder and CEO of Wheelhouse Digital Marketing Group, delves into the unique marketing challenges faced by the MedTech industry. He discusses the critical importance of continuous messaging and creative iteration in data-constrained environments, highlighting how accurate first-party and zero-party data strategies can drive performance in highly regulated markets like healthcare. He emphasizes the need for proprietary data solutions to stay compliant and effective amidst evolving privacy regulations. Reflecting on his personal and professional journey, Aaron shares practical insights on optimizing marketing strategies for better business outcomes while maintaining a culture of generosity and helpfulness. Guest links: www.wheelhousedmg.com | www.linkedin.com/in/aaronburnett | Aaron@wheelhousedmg.com | https://youtube.com/@wheelhousedmg Charity supported: https://www.feedingamerica.org/  Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 050 - Aaron Burnett [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I'm delighted to introduce to you my guest, Aaron Burnett. Aaron is CEO and founder of Wheelhouse Digital Marketing Group, a sought after digital marketing agency based in Seattle, Washington, that helps brands thrive by solving their toughest digital challenges. Every point of Aaron's career has been marked by his ability to leverage technology and his own creativity to drive growth. He has propelled Wheelhouse into working with some of the world's most innovative healthcare and medical device brands for more than a decade, consistently delivering exceptional business value through a combination of deep healthcare marketing expertise, purpose built technology, and creative capabilities. Most notably, Aaron and his team have developed technology and services that guide digital strategy for clients such as Providence, Fred Hutch, Delta Dental, and NASA. Well, welcome, Aaron. Thank you so much for being here today. I'm really excited to talk with you. [00:01:47] Aaron Burnett: Yeah, I'm excited to talk with you as well. Thanks for having me. [00:01:50] Lindsey Dinneen: Of course. Well, if you wouldn't mind starting off by sharing a little bit about yourself, your background, and what led you to MedTech. [00:01:59] Aaron Burnett: So I'm CEO of an agency called Wheelhouse Digital Marketing Group. It's a 14 year old agency. We provide performance marketing for privacy first industries. We have a particular concentration in medtech and healthcare, and have had that concentration for the last dozen or so years. We work with very large health systems like Providence, we work with some of the largest health insurance systems in the U. S. as well as large to mid size medical device manufacturers, and interestingly, we've also worked with NASA for the last six years, which is in neither of those markets but is interesting and complex and is NASA, and we get to do things on a scale that you don't get to do anywhere else. We're probably a little bit different from most other agencies, first in that everything that we do is attuned to privacy first industries. So we are, because of our long standing relationship with healthcare in particular, accustomed to working in environments that are highly regulated. So being attuned with HIPAA compliance and implications on third party tracking, working with much less data than you would work with in a typical e commerce or B2B lead generation sort of a situation. And so we have folks who are deeply expert at working in those markets, know them well, have an orientation toward performance marketing, which is what all of our clients want. They are diverse, but they're unified in that they want us to achieve an outcome with business value. It's important. It's lead generation. It's a transaction. It's something that has tangible value that can satisfy a chief financial officer. So deep expertise. We also have developed our own proprietary technologies and methodologies that help us to deliver performance marketing in these markets. So you know, in a highly regulated industry, you can't just use platform data for audience targeting. You don't get a lot of that data. You can't use platform data for optimization. You have to be very careful about what you collect and what you share and how you evaluate and commingle and analyze that data. So we've created our own HIPAA compliant data warehouse and a BI practice on top of that allows us to bring in not only platform and analytics data, but also CRM information so we can integrate it in an API level with CRM systems and first party data. So we get a lot of insight. We can see the entire user journey, customer journey, prospect journey in the context of our analysis in this platform and not share data with anyone else. So we never fall afoul of any regulations. And then our analysts can identify insights and then activate those insights in advertising platforms in sort of an air gap situation. We never have to share data. We also provide creative, but it's creative in the service of conversion rate optimization. So it's performance creative. We're not going to develop a new advertising campaign or a new branding strategy, but we are highly adept at figuring out how to get creative to perform, which is increasingly foundational to driving exceptional marketing outcomes. Now, because so much advertising is algorithmically driven and because in the absence of audience targeting, it turns out that creative variation and a really broad set of creative variation is kind of the new way to target an audience. So if you have 15 variations on a particular creative and they're attuned to different audiences and different messages, you can in some contexts rely on the platform algorithms to find your audience for you through that creative. So we're attuned to delivering that way. In terms of my own background, I started as a marketing exec. So I was a VP of Sales and Marketing with AT& T Wireless, worked for some other telecom and software companies, and started consulting and helping other folks with marketing, and found that I was good at and loved digital marketing, starting with SEO and then moving into the other disciplines. And the thing that I loved about that and that I continue to love about it is that it combines creativity, the art of marketing, with a definitive outcome which you don't get in traditional marketing. So it's there in the data, whether you did it or you didn't. And that's quite satisfying and also create security when you're working with clients. We can, at the end of a quarter say, "Listen, you're up 85%. And here's how we did it." And that creates certainty around the value of the relationship. It creates longevity in the relationship. We strive very hard to develop long term client relationships. I think our average tenure is about six and a half years now. And we find that just continuing to deliver and continuing to clearly explain what we've delivered puts us in good stead and makes for a nice, stable, and growing business. [00:06:37] Lindsey Dinneen: Nice. Well, first of all, congratulations on that business that you've successfully launched and is going strong. That's awesome. I know that's no small feat. I know a lot of our listeners can relate to that too, of being that CEO and taking on that incredible new job opportunity, and how many things you learn and the day to day ups and downs of entrepreneur. [00:06:57] Aaron Burnett: That's right. You get an opportunity to make a new mistake every day. [00:07:02] Lindsey Dinneen: Indeed. Indeed. Indeed. But that's a good thing. So that's fantastic. Thank you for sharing a little bit about that. So going a little bit back into some of your personal background, and then I'm delighted to delve into the company as well and what you do. But in the growing up, did you have an inkling that marketing would be the thing for you, or did this sort of grow out of schoolwork, or what was that thing that said, "Oh, I think I know where I want to be?" [00:07:30] Aaron Burnett: I figured out where I wanted to be by figuring out where I didn't want to be first. [00:07:34] Lindsey Dinneen: Oh. [00:07:35] Aaron Burnett: So no, the thing that I wanted to be, from the time I was seven until I was in the middle of college, was an attorney. Then the notion that I had of being an attorney was you would fight for truth and justice and fairness and all of those virtues, sort of a cinematic version of being an attorney. And what changed my mind was that I paid my way through college by working in restaurants, and in a particular restaurant in which I worked-- it was a fine dining restaurant-- there were a lot of attorneys who came in with clients or came in after work. There were also a considerable number of law school students during the summer who were taking a breather and recovering before they went back again. And I got really consistent insight and advice, which was sort of distilled. The law school students said, "Yeah, we used to think that's what this was for too. And that was beaten out of us by the second year of law school. That's not what this is for." The attorneys who were successful, particularly financially successful, they were focused on transactions and they were very conventionally successful and very apparently miserable. Then the other thing was that I came to believe that being an attorney would draw out the very worst in me. I'm a little bit competitive and I really enjoy arguing. I couldn't see how that was going to be good for me, a marriage, or being a good father, or any of those sorts of things. So, I figured out what I didn't want to do first. And then when I graduated from college, I had studied communications and then I also had studied political science and eastern philosophy and religion. And after college, I was aware that I wasn't ready to get a job, because I had no idea what that job would be. So, I went backpacking in Southeast Asia. I bought a one way ticket to Bangkok. And the plan was that I would travel for three years, and I would see in person some of the things that I studied. I would learn more and think more and get more clarity as to who I was and who I wanted to be. But that plan changed when five months into that trip, I met a woman on an island off the coast of Malaysia at a beach party during Ramadan when everything else shuts down at sundown and the only thing to do is to hang out with other backpackers. And we met and stayed up until three in the morning talking and both of us knew, like, right away, "Oh, you're the person." So we spent most of the next seven days together. Got engaged at the end of those seven days. Got married three months later in New Zealand. She's a New Zealander who was headed to Europe. And then came back to the U. S. so that she could be in the U. S. for the two years that required to establish permanent residency. And I started working for a telecom company in a temporary role. I worked there for three weeks as a temp. I was hired as an employee into the marketing department and discovered that marketing was an aptitude and something that I really enjoyed. I was also in a really fast growing company. It was a cellular company, part of Macaw Cellular at the time. And kind of the ethos there was, "Doesn't matter if you have done it, because nobody's done this stuff before. If you can do it, and you show aptitude, we're going to give you a shot." And so I got to do all sorts of things that I had no business doing, but that I succeeded at. I built a call center. I built a marketing organization of 75 employees and ran that for about three years. And I ended up becoming VP of Sales and Marketing, about seven years into that stint and just discovered that I love marketing and I particularly love marketing the intersection of marketing and technology. I love the tech part. I love developing new technology. One of the things that I did there was to develop a call completion platform for the network that we worked on that had a significant impact on revenue and a decrease in cost. So I loved identifying technical solutions and then activating them from a marketing perspective. What I also discovered, though, when that company was acquired by AT& T was that I didn't like really big companies, where you got to be VP of something very deep but very narrow, which is how that was going to turn out. And so I went from there to a series of smaller and smaller companies. And the closer I got to entrepreneurship, the happier I became, and the more at ease I became until in the year that my first daughter was born, in a job that was going super well-- I joined two years prior, the company had increased its customer base by about tenfold, things were going super well, it was five minutes from my house. It was easy, I wasn't stressed, but it was also super bored. I quit and started a company, and from there went into, I made all of the first time entrepreneur mistakes in that company. I left that company. Actually, that company left. That company didn't succeed. [00:12:32] Lindsey Dinneen: Oh, no. I'm sorry. [00:12:34] Aaron Burnett: It was great. I learned a lot. I also learned that I loved that and then started to consult and learned that. No, I actually love technology and marketing, but I love more helping people. That feels really good to me. And so sort of fast forward a few years. I created Wheelhouse for a couple of important reasons. One is I wanted to create the agency that I always wished I could hire when I worked for other companies. And what I wanted out of an agency partner was that it was partnership. It was somebody who really did have my best interests at heart that didn't deploy an account manager on me who is constantly looking for opportunities to monetize the relationship, who was playing this sort of kabuki theater where we pretend we're friends, but really it's about the change order, which felt bad on a soul level to me. And I also wanted to create this sort of place I always wanted to work. [00:13:29] Lindsey Dinneen: Yeah. [00:13:30] Aaron Burnett: I worked in larger and larger companies-- and actually this was true in venture backed companies as well-- in most instances, what I discovered is that people were asked to be someone different at work than they were at home. We have a set of values that we all agree to societally. We believe in being helpful and generous and kind. We would help anyone on the street if they asked us. If a friend called, and asked for help, you wouldn't figure out how you were going to get paid for that help. You wouldn't be playing the angles. If you were doing something with a friend, if you were coming to an agreement, if you were writing letters to an exchange of letters to agree on plans, you wouldn't be crafting the language, looking for the way that they might transgress, and you could take advantage of them. And yet, I found lots of instances where that was true in business, and that didn't make any sense to me. So I wanted to create a place that I wanted to work where the same values that you uphold that you believe in that are healthy in your personal life are the values that you adhere to in your professional life as well. And so the core values that have informed and continue to inform the way that we behave here are in part traditional. Integrity and stewardship are there, but so too is helpfulness and generosity and joyfulness. We say to every prospective client, every current client, everybody who works here, "We exist to be helpful." That helpfulness is not constrained by a piece of paper. If a client asks us for help, we will help first. We'll be generous with our time and our expertise and our resources. We'll almost certainly do work that we're not being paid for explicitly. We'll look out for our client's best interests, but we'll look out, we'll ask them to look out for our best interests as well. And we say that explicitly. And my experience is that in almost every instance, if you remind people of who they are at the beginning and that, "Hey, this is a personal relationship here. I know there's a contract and it's a business contract but as a person with my business I'm helping you as a person to achieve your aims as well. And anything we do that's detrimental has a personal impact and anything we do that's additive has a personal impact. And I'm going to try to make this the best experience for you and I'll rely on you to do the same with me." You know it creates a much healthier relationship, and that's part of the reason we have such a long client tenure. Our clients very quickly know, "Oh, you're on my side. You're going to help me. I don't have to walk around with one hand holding my wallet. I don't have to worry every time I call and ask for help. I don't have to review my SOW." [00:16:06] Lindsey Dinneen: Yeah. [00:16:06] Aaron Burnett: Pretty quickly get to a place where neither of us remember what's in an SOW. And we're only going to go back and look at it if something really gets to the size that, "Oh no, that definitely wasn't a part of this initially. We should talk about this being a separate thing." And quite often, it's the client doing that, saying, " Doing this thing, we should pay you more for that." And I love that. I see that as an indication of health. We do other things that are unconventional as well. We do have an account team. They focus on hospitality, not monetization. And one of the metrics that we track internally is laughter. So if we're in all of our client meetings, we're listening for laughter. We're not scoring it. We're not trying to make it happen X number of times, but I see the presence of laughter as an indication of ease and trust and health, and we really care about that, and so we invest in it. [00:17:02] Lindsey Dinneen: I love that. Oh my goodness. I love all of the culture that you have so meticulously crafted, and it's so interesting because as you were talking about it, I was thinking how you had mentioned early on career wise you were saying, "Well, I, I learned by discovering what I didn't appreciate." And I'm wondering then if part of the culture that you have so carefully developed and cultivated over time is also partly, "Oh, I see what hasn't worked very well in the past. So now I'm really focusing in on something that is aligned" to who you are, obviously because you're the CEO, this is your business, but also just, "this is what works well for our client relationships and everyone who works with us." [00:17:45] Aaron Burnett: Yeah, that's true on a number of levels. It's true in that, at times we see the way that other agencies or even writ large, other service organizations behave. Sometimes we bump up-- actually frequently we bump up against other agencies, particularly in large client situations. And we're really explicit in saying we're never going to try to poach business from another agency because we just don't think that's very nice. You have to behave in a very mercenary way to make that happen. You have to undercut someone. And so instead, we talk about creating the conditions that make people want to work with us. So we'll work hard to create the conditions that show us to be expert and clearly demonstrate the value that we can deliver, but we're not going to say, in contrast to those people over there. [00:18:32] Lindsey Dinneen: Yes. [00:18:32] Aaron Burnett: And there's a difference. And so, we come back to our values on that. We also, you're right in that the impetus for the culture came from me, but I also have a strong belief that everyone who comes here should add something to the culture and they are free to express the culture in their own way. Some of those ways might not be comfortable to me the ways that I would think you might go about doing this, but they're great for other people, right? And there are things in the company rights that are kind of like that where I know a majority people love this thing. It's important culturally. It doesn't do anything for me, but that's okay. And then we also have learned-- I joke that you get to make a new mistake every day and that's a joke. It's also pretty true. I make lots of mistakes. I have made cultural mistakes over the years that were very well intentioned and have been costly, either financially or culturally. I think that, you know, there are byproducts of a culture like ours that are behavioral. If you're going to be helpful and generous and pursue joy in your daily work, then the byproducts should be that you also are, you know, kind and gentle, and that you extend grace to people when they mess up. And those are great things, but taken to extreme, they also can be damaging things. And there have been times when I've taken them to extreme, when I thought with a, let's say an employee who wasn't performing well, but I had a great deal of empathy for. I would want to give them many chances and think, "Well, surely, okay, if I explained it one more time but different, or if someone else gave them clearer direction, or we did something else, we're going to get there from here." thinking, "Well, this is very kind to them. I'm giving them more runway. And it's good culturally as well. This is the right, sort of the moral decision to make." And in retrospect, that was totally wrong. It wasn't actually kind to them because we also communicate frequently. They knew where they stood. They knew they weren't performing. And this just extended the non performance in a lot of instances. It was also not kind to their team members because they had to fix the work or do the extra work. It was frustrating to them to see that their merit wasn't held in higher esteem, treated differently, that they were getting less attention than a person who was underperforming. And it took a long time for me to learn that. Other people told me I was doing that wrong for years. And in fact, there's a great book that we have used, that you're probably familiar with, called "Radical Candor" that really speaks to the importance of being quite direct, but in a kind way. And there is, there are four quadrants described in that book for different sorts of styles. And there's one just for me, I think, called Ruinous Empathy. And that's where I lived for a while. Super nice, very empathetic. But sometimes a bad result. [00:21:34] Lindsey Dinneen: Yeah. It's a great book. Highly recommend it for anyone eager to improve communication and how to give feedback and whatnot. [00:21:42] Aaron Burnett: Right, yeah. We call it telling the kind truth. You can say a hard thing, but in a nice way. [00:21:49] Lindsey Dinneen: Indeed. Indeed. And we all need that. We need that personally. We need to be able to give that. So that's incredible. So, now, specifically with medtech companies-- which I know you've chosen to really spotlight in addition to your healthcare organizations that you work with-- what major challenges or common challenges do you see medtech companies have when they're starting to think about-- well, maybe they haven't even gotten to a really good marketing plan yet because, you know, at first maybe they're just building, building and they haven't even thought, "Oh, I'm not quite sure how we're going to communicate about this." But just in general, what are some of the major challenges or common challenges that you see MedTech companies having with their marketing and how can you help? How can we help? [00:22:30] Aaron Burnett: Yeah. Huh. There are a couple of key challenges. One is figuring out messaging that resonates and drives performance. And a mistake that we often see is that messaging is viewed as static rather than iterative. It has always been the case that constant testing has real value, outsized value, particularly in digital advertising. It is exponentially true today that constant iteration and tweaking and tuning in messaging and in creative is absolutely essential to driving performance. And what also is true is that messaging and creative increasingly help you find your audience. So, if you're in a company that is highly regulated, that is governed by privacy regulations, that is perhaps governed by HIPAA regulations, you're significantly constrained in the data you have access to, the things that you can track. In the main, you can't really use third party tracking. It seems every week there is some sort of new announcement that further restricts the data to which you have access. The latest announcement is Meta declaring that they are targeting sensitive industries and categories. And that in targeting those industries and categories, they're going to block certain types of data, and the data that they're blocking in the main is conversion data. And so, you're blind with regard to whether anybody actually did the thing you needed them to do. Did they sign up for a trial? Did they complete a lead form? Did they ask for follow up? If you're using a conventional approach to those sorts of things, if you're using certainly their tracking, which I hope nobody is doing anymore, then that data just goes away on some date. But as you lose fidelity of the data and as you take into account sort of the more meta issue, not Meta the platform, but the global issue of cookie deprecation and privacy settings in browsers and the fact that already about 40 percent of the third party data that you would have gotten through browser signals is gone. You've lost fidelity. So the way that you find an audience now, particularly in a data constrained environment, is through what you put into market. It's messaging variation, and it's through really significant creative variation, not one ad, two ads, three ads, like old school conversion rate optimization, but 15 ads. 15 different creative concepts with variation of messaging that look very different. And as you do that systematically over time, you allow the algorithm to both optimize performance, and those algorithms work very well now, but increasingly-- and this is particularly true again on Meta which we find to be really powerful when done well for medical device clients-- you find that you don't just optimize the creative. In that optimization, the creative finds your audience for you. You're able to tune your creative to the audience that performs for you and continue to iterate in terms of both audience targeting and creative. So first there's, there is a need to test into all of this. And there is intensive testing at the beginning of the process, but there's continuous testing, perhaps at a lower velocity or intensity, even as you go along. It doesn't stop. You don't get to a point where, "Oh good, we're on cruise control. We've got the ad that works. We've got the PPC that works. Everything is working well." It's just constant iteration because it is algorithmically driven and because in the algorithms, you know you can think of this in terms of social media. In social media, I think people are familiar with algorithmic fatigue. If your algorithm in a personal feed on a social platform didn't change, didn't refresh fairly frequently, you get really bored with what you're seeing. The same is true in the platforms. And so we find creative fatigue, even with creative that performs super well, happens fast-- like a week, ten days, something like that. And the fall off isn't subtle. It's you're going along and you do that. It's a big drop. So it's constant iteration. The second thing that we find is a lack of, I was going to say a lack of sophistication with regard to data strategy. It's actually more often the absence of data strategy. I think for a long time data strategy didn't need to be foundational to marketing, even to digital marketing. If you think of digital advertising or even organic forms of digital marketing, the platforms did the work for us. You targeted audiences in the various advertising and social platforms. You got all your data through analytics. You could see what was happening in search through search console. Perhaps you use some third party platforms as well. But what is true now in a data constrained environment is that the most important signal, the signal that delivers greatest value, isn't the signal that's in the platform. It's the signal that's probably in your CRM. It's the one that tells you that a lead converted, someone actually went into trying a device, or they actually became revenue generating. So you need a strategy at a system, at a platform level, to bring all of that data together and to normalize it in a manner that enables it to be evaluated and analyzed as a corpus of data that enables you to see the entire user journey. You need a strategy around naming conventions in advertising that allows you to bring that in a way that can be integrated with CRM data and other analytics data or other platform data. You need a first party data strategy, because in a data constrained environment, in a tracking constrained environment where you can't rely on third party data in the same way, audience targeting and even optimization now rely substantially on first party data. It's the data you own that you have permission to use, or on zero party data. Well, you can't put that in a public database. That has to go in a purpose built data warehouse that has been developed for privacy sensitive industries. And so, in our case, we created a HIPAA compliant data warehouse and a BI practice on top of that that gives our analysts the ability to view the customer journey in entirety, to see people as they move through sort of the prospect funnel, and to optimize for the conversion step that isn't in the platform but delivers business value. And then to use the insights that they glean there to optimize in a platform without sharing data, which is the key. You're able to know, and this is something for people to remember, despite all the increased privacy regulations and constraints, as a website owner, as long as you have the right data environment, meaning the data you collect is in a HIPAA compliant environment, if you're governed by HIPAA, certainly in a privacy sensitive environment, even if you're not, you can collect full fidelity data regarding what people are doing on your site. You can't share it with a third party platform, you can't send it to Meta, you can't send it to Google, but you're able to know everything that you knew before, so long as you collect it in the right way, and evaluate it in the right way. And our experience is, the privacy regulations, despite being uncomfortable and alarming and forcing a lot of intense activity up front to create a new systemic approach, new infrastructure connections and new data strategies, actually yield a much better business outcome. We can drive better performance with first party data. We drive more business value with first party data than we did when we were doing it the easy way and using platforms for targeting and optimization. [00:30:27] Lindsey Dinneen: Yeah. Okay. Yeah. So, so your company really helps to bridge the gap between what maybe, if you're not into the nitty gritty details, say we're speaking with somebody who's developed a device what they may have learned as, as far as like Marketing 101, but it is so different when you have, like you said, very specifically protected industries and they have a lot of regulation and we have to be really careful with how we talk about things. So your company is really helping bridge that gap between what we may have all been taught and kind of know in the back of our head versus here's the actual reality of the situation today. And you're keeping on top of all of those regulations. [00:31:08] Aaron Burnett: True. And then, you know, because we concentrate on the medical device industry, we also are highly attuned to what language we can and cannot use. And we know, alright, we need creative variation, but we also understand that we can't just test anything. That we need to be very careful with language, we have to use language that's approved, it needs to come from certain sources and not from others. If it's new it has to go through a certain approval process. So, we end up creating a lot of efficiency by simply knowing how it all works and having a lot of experience with needing to create new ad variations that win easy approval and can very quickly be put into market. [00:31:50] Lindsey Dinneen: Yeah, of course. Now, you know, in working with MedTech and you've chosen again, some very specific niches, which I love. Have you had any moments that really stand out as, "I'm working with this client and I am in this industry and I am realizing, 'Wow, I am really in my element.' I am here for a reason." It just sort of stands out at this moment that matters. [00:32:15] Aaron Burnett: Yeah. One of the clients we've worked with for a very long time has an insulin monitoring and delivery device. We worked with them when they were sort of mid sized, but also kind of looking for market fit in their digital marketing was dormant. Almost dormant. I'd put it on the verge of dormant. It wasn't doing well. So, we started on a series of projects with them, and they started quite small, and very quickly were able to deliver a lot of performance for them. So, the first year, we increased lead generation by just under 500 percent for them, which was super meaningful and exciting, and enabled us to start this very long term relationship that is broad and multifaceted now. What I've loved about working with them, and we were talking about this when we first got online, is that the people who work there really care about the people they serve. And as a matter of fact, there is almost a universality in that the people who work there either have close friends or family members who deal with diabetes. And so it's not a commercial endeavor. I mean, it is, but it's also a very personal endeavor and they're aware and convinced-- and I think they're right-- because I also have a close family member who uses their device, that their device makes such a difference to the quality of life for the people involved. The difference that I've seen in this family member is that she went, I think, from being aware, moment to moment, "I'm diabetic and I need to keep track of this, and there are some things I need to do at certain points throughout the day," to "That's not really a main thing I have to think about. I mean, I have to be kind of aware of it, and, you know, I've got an app on my phone, and I do have this device, but this is not something that is at the forefront of my brain. I can think about other things, and this is very much in the background." And that's a really big deal. And we feel the same. I know I have been to public events. I went to a high school play and one of the performers was very clearly wearing this device and not hiding it. It was super visible just a part of her life, not anything she felt embarrassed about. And I felt proud of that, even though I have, I play such a small part in that. But, just felt proud that she felt comfortable, and she was a lead in a school play, and it was a good play, and a big deal, and there were hundreds of people in the audience. And so, to see the impact of something like that, and to have confidence that the work that we do actually makes a positive difference in the world, is soul satisfying. [00:35:00] Lindsey Dinneen: Yeah. Thank you for sharing that story. That's, that is really special and impactful. And I always think, you know, we don't always get those moments of realizing the impact of our work. I agree with you, even in the small, like, "Oh my gosh, I had a tiny little piece to play in it." But it just makes you think, "Oh my goodness, what I do really does matter. It does make a difference." And so to get that opportunity to have seen it in action and in such a positive light is incredible. So yeah, I appreciate you sharing that. [00:35:29] Aaron Burnett: It's comfortable. It feels so good to market for clients when you're sure that what you're putting in the marketplace is really good for them. And what you're trying to do is just make sure they're aware of this good thing. That's so different than marketing for a client where you're sure they want to make more money and you're not sure that anybody who buys this thing-- does it matter? Does it not matter? Does anyone really need this thing? You know, that's a very different feeling than being confident that the thing you're promoting will make a positive difference in their lives. So, yeah. [00:36:09] Lindsey Dinneen: Amen to that. And that's a really interesting thing about marketing that can be divisive a little bit among people who aren't as familiar with the industry or as comfortable. And so it's really nice to know, you know, marketing can, and is very often, used in a very positive way to highlight the important things 'cause you know, as I try to remind my lovely engineer friends is you can make the most wonderful thing in the world, but if nobody knows about it, that's that. You know, that you're just, you're stuck. So, so it is important to have marketing and to have that bridge that gap and make it known. But to just know, like you said, that it's going to make a positive impact is just wonderful. So yeah, I love that. So pivoting the conversation a little bit, just for fun, imagine that you were to be offered a million dollars to teach a masterclass on anything you want. It can be within your industry, it can be totally separate. What would you choose to teach? [00:37:07] Aaron Burnett: Oh, the power of culture. [00:37:09] Lindsey Dinneen: Ooh. [00:37:10] Aaron Burnett: And if I had to focus more specifically on the power of generosity in business. My experience, our experience throughout the history of this company, is that helpfulness and generosity are our BD strategy. We're not trying to convince anybody of anything. We're trying to give as much away as we can be as generous as we can. And we find that if you help people, if you are generous and if you do it without expectation-- and I can't fully explain why this is true. I have some guesses. If you help people without expectation, you just help them because you're helpful, and that's the right thing to do, and you do that for a person, that good things happen out of that. I think I can explain it. I can understand it more mechanically. I might bump into you. We may or may not know one another, but we get chatting, and you tell me you've got a problem, and I know the answer to that problem. It's also a service that I offer. And I could certainly play the angles and try to get an engagement to get you to pay me for that service. I could just help you. And you may or may not ever become a client, but I've helped you. And my experience with that is that we've gotten referrals from people who have never been clients. And sometimes those referrals occur years later, like long enough that we only vaguely remember who that person was and what we did for them. But I think that being generous, you can't tell someone to trust you. But you can behave in a trustworthy way. You can't tell someone in a way that inspires confidence, "Look, I'm gonna look out for your best interests. I'm not gonna try and pick your pocket." But you can behave that way. And you can communicate it with your actions. So, I think it's interesting to consider what business and society would be like if the orientation was toward generosity rather than the orientation being toward protection. When we write SOWs, for the longest time we wrote the most naive SOWs. And we did it intentionally. A, because, practically, we're a small agency working with big clients. And if somebody wants to take advantage of us, they probably can because I have a limited attorney budget, and I don't really want to spend my budget on that anyway. But the other reason is that I that seems to have integrity with what we say. We're going to be helpful and generous. We're going to do work you're probably not going to pay us for. We'll look out for you. You look out for us. We're not going to get you with business terms. We're not going to squeeze you with scope of work, that sort of thing. So, let's not kid each other. Let's not now create this document that's super conventional and has five pages of terms and conditions and that sort of thing. It's honestly only as we've worked with larger and larger organizations where their legal teams won't let them sign an SOW that's as goofy as ours were. You have to have certain terms and conditions, and if we don't provide them, they send us theirs. We don't like theirs as much as we like ours, so. Yeah. Yeah. So I think generosity is a tremendous engine for very healthy business growth and very healthy personal relationships. [00:40:30] Lindsey Dinneen: Absolutely agreed. And how do you wish to be remembered after you leave this world? [00:40:36] Aaron Burnett: As kind. [00:40:37] Lindsey Dinneen: The world needs a lot more of that, so I'll take that answer any day. And then final question, what is one thing that makes you smile every time you see or think about it? [00:40:50] Aaron Burnett: Oh, I have two daughters. Yeah. [00:40:54] Lindsey Dinneen: Yeah, excellent. Oh, that's wonderful. Family is important and special. That's wonderful. Well, thank you so much, first of all, for your incredible insights today, for your generosity, to your generosity of your time with us and diving into some really specific areas that, that med tech companies can think about, can be aware of as they're even seeking somebody to help them with their marketing. I really appreciate you being open and willing to talk about some of those those nuances. So thank you very much for that. We are so honored to be making a donation on your behalf today to Feeding America, which works to end hunger in the United States by partnering with food banks, food pantries, and local food programs to bring food to people facing hunger and also they advocate for policies that create long term solutions to hunger. So thank you so much for choosing that charity to support. And gosh, I just wish you the most continued success as you work to change lives for a better world. [00:41:55] Aaron Burnett: Thank you. I really appreciate it. You too. It was a great conversation. I really enjoyed it. [00:41:59] Lindsey Dinneen: Good. Absolutely. Well, and thank you also to our listeners for tuning in. And if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two, and we will catch you next time. [00:42:14] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Scott Burwell, PhD, is the founder and CEO of Neurotype Inc. Scott shares his journey from a background in experimental psychology to establishing Neurotype, a company developing brain therapeutics to address cravings in substance use disorders. He discusses the innovative use of EEG technology to measure brain responses to stimuli, providing an objective biological assessment and treatment of cravings. Scott emphasizes the importance of integrating science-led approaches in creating medical devices and reflects on the challenges and rewards of leading a MedTech startup.   Guest links: https://www.neurotype.io | https://www.linkedin.com/in/scottjburwell/ | https://www.linkedin.com/company/neurotype Charity supported: Equal Justice Initiative Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 049 - Scott Burwell, PhD [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and I'm so excited to introduce you to my guest today, Scott Burwell. Scott is the founder and CEO of Neurotype Inc, developer of new brain therapeutics to make environmental triggers less problematic for people in recovery for substance use disorders and other addictions. Well, hello, Scott. Thank you so much for joining us today. I'm so excited to speak with you. [00:01:17] Scott Burwell: Great. Thanks so much for having me, Lindsey. Thanks. [00:01:19] Lindsey Dinneen: Of course. Well, would you mind by starting off and tell us a little bit about yourself, your background, and maybe what led you to MedTech? [00:01:28] Scott Burwell: Sure. Yeah. So, I have a background in experimental psychology, a PhD in psychology from the University of Minnesota. And kind of what led me to that was experience: my family had a liquor store growing up and I worked there for many years. And so I saw firsthand from behind the counter people with substance use disorders occasionally, and just knowing from extended family, substance use disorders, and it was an interesting observation to me to see different people, how they get to a substance use disorder. Some through genetic propensity and some through experiences in their life. And that led me to get a PhD in psychology where I really focused on the genetics and physiology underlying substance use disorders. And during this time of getting my PhD, I was always trying to think of, where does my skill set and my interest align in the future? What kind of job am I going to have after this? So I looked around. I had some experience, thought, "Could I go the academic route? Could I apply for grants, be a professor at a university?" That approach, which is a very good approach for some people, where your main outcome are publications and grants and dissemination of science. And then I also looked at industry, but a lot of the companies in industry weren't doing exactly what I wanted to do, which was take these biomarkers that we were studying in psychology and transforming that into medical device or medical innovations. And then the third path that I didn't quite see at the time was this sort of like rabbit hole, this unknown path of medical device innovations or startup innovations. And it was an eye-opener to me through some programs at the National Institute of Health, National Institute on Drug Abuse, that led us to this opportunity that actually, I could start my own startup in this space. And and I'm happy to talk a little bit more about that, that later. But really, this opportunity to make something new, based on the science that we know today, and based on the opportunity and the gap in terms of what people are being treated for with these substance use disorders. So that's kind of what led me down the path, and happy to talk about it today. [00:03:41] Lindsey Dinneen: Yeah, excellent. Well, thank you for that. And yeah, I'm so excited to delve into so many aspects of your story. So going back just a little bit, you had this childhood where you were observing and you were seeing what was happening to some folks and you thought, "Okay, maybe there's a better way, or at least I'd like to understand more about this." But now, were you always sort of science minded and kind of interested in going into psychology, or did that come about as a result? How did that interest develop? [00:04:10] Scott Burwell: Yeah, really, I never saw myself getting a PhD, never saw myself going to an academia setting. People with graduate degrees, people with doctoral degrees-- all those people seem to be other people and not something that what we did. But my parents really instilled an appreciation of higher education in myself and my two older sisters. But again, it was never this plan for me to go out and get an higher education, PhD degree. I think that what really led me to the path was just try to understand myself. I think that's what led me to psychology. It was a psychology class in behavior genetics that I took in undergraduate that, you know, behavior genetics is the field of understanding how your genes and your rearing environment lead to who you are and influence who you are. And it was one of these, this realization that actually it's not just your experiences, it's not all just the soft, mental processing and soft psychological experience. There's really a physical, biophysical basis, to a lot of who you are and who you turn out to be. And I think that was really eye-opening to me and helpful for me understanding who I was and how I am in the world. And I think, you know, just that little bit of information of understanding, there's this objective information that is programmed in your genes or programmed in your physiology that influences who you are in everyday life, that I found super interesting and eventually led me to work at the Twin Study at the University of Minnesota. And then and then while I was there, I realized there's a lot of people getting PhDs that I'm not that much different from and we're all just curious people. And it's an opportunity for me to, you know, if I apply myself, it was an opportunity for me to pursue a field. [00:06:06] Lindsey Dinneen: That's very cool. Yeah. Okay. So, so you're pursuing this field and you've already had this background and interest in helping folks who have these substance abuse disorders, and I'm wondering, what were you observing as you have now developed this company? And I'm so excited to dive into that as well, but a little bit before that, what were your observations when you started realizing, "Okay there's a gap in the way that we're treating this or handling this or responding to this." And then what was the outcome for you that you thought, "Okay, let's try something different." [00:06:42] Scott Burwell: Yeah. So a couple of things. I think the first thing is that, the treatment of substance use disorders and all behavioral addictions and to some degree mental health is been sort of a parallel development. It's been a, it's been a parallel field that's been outside of the rest of the way that medicine is traditionally done. And so, even though we have for some substance use disorders medications for management of the substance use disorder. Or there are social support groups, AA, Narcotics Anonymous also, that help provide social support to people with substance use disorders. These are sort of groups and services that have been built outside of traditional medicine. And with the exception of these services, there haven't been too many medical innovations, FDA regulated innovations that doctors can prescribe for people with substance use disorders. And this is despite decades of research that are showing there are biological underpinnings of substance use disorders. There are biological interventions that, that can potentially help people with these afflictions. And so, that was one of the pieces that during my training, I was just constantly looking for companies that were doing this kind of work to treat disorders from a biological or psychobiological perspective. And I just wasn't finding anyone. And also at that same time, the DSM Five, the Diagnostic and Statistical Manual for substance use disorders, the criteria that sort of outline what it takes to get a diagnosis had just included the symptom of craving. It might be surprising to people, but it's only been since about 2013 or so, that craving has been an official symptom of a substance use disorder. And I mean, that's despite again, decades, many years of people reporting cravings being an issue that they deal with day in and day out. And so I was aware of this addition of a new symptom, but also I'm aware of the fact that the way that substance use disorders are diagnosed, they're assessed, they're monitored, is entirely subjective, meaning that people are reporting these symptoms in an interview in a one on one kind of subjective interview that people can report what they believe, report what they experience, which is valid information. But sometimes what you're aware of, what the clinician is aware of, might not be what's going on an objective biophysical level. And so I was aware of a certain biomarker that you can measure with brain waves using electroencephalogram or EEG and this biomarker is what leading science says is the biomarker underpinning of craving. And so I felt, well, you know, if there was a way that clinicians had this in their hands as either a diagnostic assistant or as a way to treat people with craving, this could be a valuable medical device that people can use. And so, I can talk more about the specific biomarker, but these were two realizations that I saw that there's a lacking and a need for innovation in this field. [00:10:03] Lindsey Dinneen: Great. Yeah. Okay. So yeah, could you share a little bit more about the biomarker and then how you have found, how you have discovered to affect this and what this device is and how it works? [00:10:14] Scott Burwell: Yeah, so Neurotype Inc., we were founded in 2019. We were founded after we were participating in this workshop at Yale University called Innovation to Impact. It's funded by the National Institute on Drug Abuse. And we really pitched this idea to them as kind of a off the cuff, last day of the workshop pitch event and won first prize in that thing. And that's really what gave us the steam to go ahead and apply for these federal grants to support further development of this biomarker. What the biomarker is, basically we put a headset on you and that headset is kind of like a fitness tracker except other than being like a fitness tracker that's tracking your steps from, you know, a watch or, you know, being a glucose monitor that's on your arm, that senses how much blood sugar you have, this fitness tracker is on your head. It measures the electro physiology that's generated by your brain. And it's entirely passive in that regard. We're not putting any like, you know, electrical stimulations in, but it's just measuring how your brain is acting at all moments. And what we do is that's different from other companies is we're actually recording how your brain responds on a millisecond scale in response to pictures. So we hand somebody an iPad while they're wearing one of these headsets, and we show them a flip book of pictures. Some of those pictures are like chocolate cake, puppy dogs, you know, cute, emotional pictures. Some of those things are boring things like kitchen supplies, office supplies, whatever they might be. And then some of those things are like opioid pill bottle, right? And so, for opioid use disorder, if you are liable for craving, and if you're likely to start reusing after being discharged from treatment, your response to that opioid pill bottle, the brain response, the objective brain response, is going to be very similar to how it responds to, for instance, chocolate cake, than a person that's not at risk for returning to opioid use or other kinds of craving. And so this biomarker is really a biomarker of what's called 'motivated attention.' How interesting you find that stimulus on the screen and how much it grabs your attention. And what we know from psychology is that if something grabs your attention, you're likely to behave in a way that is going to correspond with that. So if it grabs your attention, you're going to act a certain way around that stimulus. And so for people with opioid use disorder, it might be that it stimulates some thought process or some behavioral process in your body that leads you to seek that substance, affiliate yourself with people that have that substance, you know, all sorts of indirect ways that eventually lead you to start using that substance again. And so, we have done a few different research projects funded by the National Institute on Drug Abuse, and these are different projects over time that have really established the core assessment capabilities of the device. And now we're working towards clinical trial validation through a small business innovation research project from National Institute on Drug Abuse that will be a pivotal clinical trial for us. [00:13:30] Lindsey Dinneen: That's really exciting. When does that happen? [00:13:32] Scott Burwell: So, that is part of what's called a fast track project, and we are finishing up our phase one portion of that. And the phase two portion will probably start sometime this coming summer. Yeah. [00:13:45] Lindsey Dinneen: Great. Okay. That's great. And so what is your dream or ultimate ideal goal for the company and for this device? What are you hoping to affect or where are you hoping this device will be used? [00:13:58] Scott Burwell: Yeah. So, our main goal or our first sort of beachhead market, if you will, is the intensive outpatient treatment clinics for substance use disorders or other mental health. It's a certain kind of clinic where people are seen on a pretty regular basis during early recovery when they're still in a kind of high risk period. And in this group of patients, they tend to be in a scenario where they are living at home or living in the wild, so to speak, it's no longer a residential treatment setting. But they are living and being challenged day to day with the triggers in their environment that, that can lead to risk for problems. And the interesting thing about this space though, and this market is that in that space, there really are not many regulated, or any regulated devices, that are being used to manage specifically certain symptoms. And especially none that are applying to brain physiology like ours. And so, it's a pretty big step to bring our device to these spaces because they might be familiar with a blood pressure cuff or people might get blood work done from time to measure other health related risks. But for us, we are bringing an EEG system, and it's a portable EEG with a software device, into a clinic where they've never been before. And so my grand vision for this is really to be, you know, we're not a fix all. We're not a cure-all solution, but we are solution to help one specific slice of somebody's condition, and be a fix for craving in these settings. But if we can get the device in these clinics settings, it opens the door for a whole lot of other biomarker solutions to take place. And so right now, we're just focused on craving, monitoring the craving, but also treating the craving through what's called closed loop biofeedback. But the but the long term vision for this is to do-- we can additionally build out with the same brain kind of assessment, we can build out other kinds of biomarkers. So, those that are related to genetic risk. So we don't have to do like a full genetic test, but we could use that same brain data to to study what are called endo phenotypes, but basically a genetic marker of risk for a certain disease type or a certain disease progression. We could also measure other aspects of distress or you know, other depressive symptomatology or things like this with our measures. So, I think if I were to, at minimum, if we were to be able to make a dent or just get our device into these intensive outpatient clinics, that would be a huge success for me and the company. But, I think much grander speaking, it would open the doors for a lot of more transformative addiction treatment care. [00:16:56] Lindsey Dinneen: Yeah. Yes. Okay. Well, that's incredible and thank you for sharing your vision, 'cause I always love hearing, all right, what's the longterm heart for this company in this project. So that's great. Yeah. Are there any moments that stand out to you, maybe as you're developing this device or maybe even before as you're studying the biomarker and you're thinking through, you know, how can I make a difference in this particular indication? So are there any moments that stand out to you as really affirming to you, "Yes, I am in the right place at the right time. Doing what I'm supposed to be doing." [00:17:32] Scott Burwell: Yeah, I think one piece was when we won first place at that at the Yale workshop that we did. I would say another was just getting each of these grants. We've applied for grants over and over again. And you don't get every one of those grants. But when you get certain projects, and when you're awarded these monies, it is incredibly validating because, you know it's gone through scientific review at the NIH. You know that also at the specific institute, so National Institute on Drug Abuse or Alcoholism or Mental Health-- they're different -- that this is an intense area that they see value. And so when you get these projects, and we've gotten over a million dollars now in these projects, that there's some validation behind it from federal and also a scientific level. So that's one area, but then I would also say that, when talking to clinicians, we talked to clinicians and we talked to some patients about the device, and we demo the device and demo the technology with some clinicians and patients. And, people will come back and be like, "Wow, why is this not out there already? Why don't we have this kind of data?" And to me that is incredibly rewarding to just see people and their immediate responses to the technology, because I don't think anyone really knows that this science or this technology is readily available. It just needs to be packaged in the correct way. And it also has to go through the correct regulatory and reimbursement pass. I mean, to just say "just," I think that's probably an understatement for sure. But, the science has decades of work behind it. And really it's up to us now to move that, to make it to that next milestone, that next goalpost. And that work isn't really science. It's just hard work. [00:19:14] Lindsey Dinneen: Yeah. Yeah, indeed. Well, speaking of hard work, you know, forming a company on its own, working in the medtech field on its own, all of those things are difficult challenges to choose. And I'm curious, how has your personal path been in terms of growing into this leadership role where you are directing this company and directing people. How's that journey been for you too? [00:19:43] Scott Burwell: You know, I think it's been a journey. And when people say that you can't do it on your own, that is 100 percent true. And even if you hear it and you believe it, sometimes I think it takes a lot for me to come to the realization to put that into practice. I tried to do a lot on my own. In the team, I am the CTO, the CEO, the COO, all these different roles that I've assigned myself. We participated and were awarded into the-- NIH has this program called Innovation Core, iCore. And we did this program and one of our mentors there was really harping on the idea of leaning into your what are called core competencies. So what are you actually really good at as a team and as a company? And what are you less good at? And and I think that the more that I've learned to lean into my core competencies, which are really around the science, the translation of the neuroscience, the translation into a clinical tool that can be used, thinking about the vision of our technology. And tried to offload some of the other things, whether it be regulatory or whether it be some aspects of business strategy or other otherwise to, to other people that can help in a fractional sense or whatever to help us out. That's helped me both maintain my role as a leader and keep on doing the work that I think that I can actually contribute to and be useful contributing to, as well as keeping the company afloat in terms of funding and just hitting our milestones on all the different projects that we've been awarded and need to produce for. So, so I would say that, you know, I'm no, I'm not a perfect leader. I'm not a perfect CEO by any means. But I, but as I go on, I kind of learned that you can't do it all yourself, and you can't accomplish everything to the same degree as another person possibly could. And so trying to build good teams, trying to lean on team members that can do certain things, finding the strengths in certain team members and asking them to do the right kind of work given their skill set. But I think that's been a crash course for me. [00:22:00] Lindsey Dinneen: Yes, indeed. Well, that makes complete sense because, you know, like you said at the very beginning, it is a journey, and it is a constant learning and growing process. So yeah, that's, that's fantastic. Well, pivoting the conversation just for fun, imagine that you were to be offered a million dollars to teach a masterclass on anything you want. It can be within your field. It doesn't have to be. What would you choose to teach and why? [00:22:29] Scott Burwell: Oh my gosh. Well, You know, I think that-- I'm not sure anyone would offer me a million dollars for this. But if I had the time, I think If I had the time, I would actually really love to teach a masterclass on how to do this sort of neuroscience innovations. There's a lot. This is a really hot area for startups and innovations, the idea of using neuroscience tools as products. There are companies out there like the Muse headband or there's Nurable, which makes these smart sort of headphones that also measure brainwaves. Neurocity is another company that's doing things for productivity. And I know people at these companies. They're all great companies. And these are some very successful examples. But there's other companies out there too that, that are doing things that I feel are led by engineering first. So, just because you can do something, it doesn't mean that you should do something. And it doesn't mean that there's any validity to what it is that you're doing. So, you know, there's a lot of interest in that. Around developing brain computer interfaces or other kinds of neurological or brain diagnostic or treatment devices. They're doing brain stimulation or brain sensing or biofeedback or all these sorts of buzzwords. I think we're kind of part of that group, honestly, but the difference between us and the others is that we are science led and a lot of these other companies are engineering or technology led. And when you lead through something, when you start by innovating by technology and innovating by engineering, that's great from a perspective of showing others that you have a tool. But without a use for that tool, and without evidence from science that tool actually does something useful, then it's kind of useless. And so a lot of those companies go broke because they don't have a user for that tool or the tool that they built doesn't actually do what they intended it to do. So one thing that I think I would do in this course, if I were to do this course, is to really emphasize like, here's how you can approach certain kinds of biomarkers. Here's the types of biomarkers that people actually think is correlate with a disease, major depression, ADHD, substance use disorders, whatever it is, and actually have a scientific grounding versus building a headset that does XYZ first and not really having a scientific basis. One, one tip I would just offer people is just get a PhD that has the background in that content space first on your team, because they will tell you what the field thinks of it. And a lot of times, the field thinks that a lot of the products that are being developed out there are just snake oil. And so, so really, you know, do your diligence on the science before diving into something. [00:25:27] Lindsey Dinneen: Cool. Yes. I'm sure that would be a fantastic masterclass and very needed. So, all right. Sounds good. All right. And how do you wish to be remembered after you leave this world? [00:25:40] Scott Burwell: Great question. You know, I would love, like I mentioned earlier, for Neurotype to play its part in establishing these kinds of brain biomarkers in the treatment for behavioral and mental health disorders. I would love for us to be a building block for what the future looks like. I think we're using the most current science available to build our innovation. And if we can be sort of that first step into the future, I think that would be so great. And the science will change in the future, but I think that if we can be that stepping stone, that would be ideal. I think on a more personal level, I think I would love for anyone I know, anyone that I come into contact though with, I really want to be remembered as a person that's just been kind to you. If you can remember one moment that that you felt like, "Oh, Scott made me feel good in that scenario" or "Scott was helpful in that scenario." I think that would be a more realistic grab or a closer term grab. So, so, you know, both those things I think would be great. But in the day to day, I really work to at least hope that people remember me and felt that I was kind to them. [00:26:48] Lindsey Dinneen: Yeah, absolutely. Kindness makes all the difference. Yeah! Okay, and then, final question. What is one thing that makes you smile every time you see or think about it? [00:27:00] Scott Burwell: Oh, geez. I think, you know, Is it is it okay to say cute animal memes from Twitter or something? But so... [00:27:08] Lindsey Dinneen: Sure! [00:27:09] Scott Burwell: I love cute animals. I love any cute animal or cute baby thing on Instagram or wherever. But I will also just say, back to the impact aspect of our company, we do research with people. We do early demo testing with people with substance use disorders. And some people struggle, they're in and out of treatment programs five, six times before something really starts to click. And they put in so much hard work and so much effort to keep on their pathway, unique pathway to recovery. And so, you know, I think that I'm really encouraged and really puts gas in my tank when I see people that are doing well and that they're happy. And because there's some degree of pride that person carries around and some, and and maybe that pride was not necessarily there beforehand. And so, you know, I think that I will, regardless if they are achieving their goals and living a happier life because of what Neurotype is doing, or something else, really doesn't matter to me. When I see people that are doing better, it is warming to my heart to see somebody that has made some sort of sustained change in their life that is impacting them in a positive way, because it really does show that people can change. People can do what they want to do and live the life that they want to live in many cases when they. are given the opportunity. And so that's heartwarming to me. [00:28:38] Lindsey Dinneen: Absolutely, yeah, absolutely. Ah, that's wonderful. Well, yes, and also, awesome little cute memes are the best, especially with animals, oh my gosh. [00:28:48] Scott Burwell: I know. Yeah. [00:28:49] Lindsey Dinneen: I spend way too much time looking at baby animals, but I always smile, so, you know, win. [00:28:54] Scott Burwell: Yes, it is. It's the main, it's the main way I get my little like boosts of dopamine throughout the day for sure. [00:29:00] Lindsey Dinneen: Yes, absolutely. Well, Scott, this has been a fantastic conversation. I so appreciate you joining me and sharing more about the work that your company is doing and all the innovation. I'm so excited to watch it continue to succeed. So thank you for spending some time with me today. I appreciate it. [00:29:18] Scott Burwell: Absolutely. Thank you, Lindsey. Thank you. [00:29:20] Lindsey Dinneen: Of course, and we're so honored to be making a donation on your behalf as a thank you for your time today to the Equal Justice Initiative, which provides legal representation to prisoners who may have been wrongfully convicted of crimes, poor prisoners without effective representation, and others who may have been denied a fair trial. So thank you so much for choosing that charity to support. We just wish you continued success as you work to change lives for a better world. And thank you also to our listeners for tuning in. And if you're feeling as inspired as I am at the moment, I would love if you would share this episode with a colleague or two, and we will catch you next time. [00:30:02] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development. ​

Isabella Schmitt is a prominent life science, AI, and regulatory affairs leader, and was recently named one of the top 100 MedTech Leading Voices Worth Following on LinkedIn in 2025. Isabella shares her diverse career journey—from aspirations of neurosurgery to becoming a regulatory expert in MedTech and biotech. She emphasizes the importance of early regulatory involvement, strategic use of pre-submissions, and understanding the voice of the customer in product development. Isabella also discusses the critical role of communication skills in regulatory affairs and offers invaluable advice for aspiring professionals.   Guest links: https://www.linkedin.com/in/isabella-j-schmitt/ Charity supported: Polaris Project Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 048 - Isabella Schmitt [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey. And today I am so excited to introduce you to my guest, Isabella Schmitt. Isabella is a life science, artificial intelligence and regulatory affairs leader with expertise in navigating the intersection of science, technology, policy, and innovation. With a robust background in medtech and biotech regulations, she has contributed to over 200 projects ranging from hardware and software medical devices to AIML products. Isabella holds an MBA from Texas A& M and is pursuing advanced studies in AI management and policy at Purdue University. Known for her engaging communication style, she is a sought after speaker, author, and consultant on AI regulation and innovation. All right. Well, welcome to the show, Isabella. I'm so excited that you're here. [00:01:41] Isabella Schmitt: I'm excited to be here. I feel like it's been a long time coming as we just talked about a second ago. We've been needing to connect for a while so I'm glad we're finally getting to do it. [00:01:50] Lindsey Dinneen: Me too! Well yes. Thank you for taking some time today. And I wonder if you would be willing to start off by sharing a little bit about yourself, your background and actually what led you to medtech. [00:02:00] Isabella Schmitt: Yeah. So it's an interesting story because I actually have a pretty varied background in general. Like if we start back, back in high school, even so we'll go that far back, I wanted to be a neurosurgeon originally in life, and... well, originally I wanted to be marine biologist, but that was when I was in elementary school. No, I wanted to be a neurosurgeon probably from the time I was like, 14 to like, 21. And then I did a surgical externship and I didn't love it. And so then I had a quarter life crisis where I was just like, "What do I do? This is what I've wanted to do for so long." And then I found myself going into research, so I did a lot of lab work in primarily healthcare type things. So, with nanomaterials for oncology, you know, specific targeting of tumors and things like that. But then I found with that, I liked the design of the experiments and like the design of new inventions and all of that, but I didn't actually enjoy the lab work. So like the actual part of being a researcher was not fun for me. And so, I shifted gears, had a little kind of a stray off of the, this normal trajectory, I guess. And I was like, "Oh, well, maybe I want to do veterinary medicine." I love animals, so I did that for a little bit. And then I felt like there was always this drive for me to do something that felt good, aligned with my values, right? But was also intellectually stimulating so that I felt like I was constantly challenged. There was something new. It was very diverse. A little bit of ADHD there, right? So like I need, I need lots of inputs and stimuli. And so I, with veterinary medicine, I felt like I really liked this. It was ticking the sort of values box, but it wasn't really ticking the other boxes for me. And so then I kind of went back and was like, "Well, maybe I want to go to medical school. I'll revisit that." So I took a job at a pharma company, a midsize biopharma company. And I started off in the clinical research side. I didn't know anything about the industry at this point, 'cause they don't really teach you anything about biopharma or medtech in school. I don't even know what I thought about how products like drugs and devices got to market. I just kind of assumed someone was checking over that, I guess. And so I had no idea and I took the job thinking it was more truly clinical related. Like, I was going to be, I don't know what I thought I was going to be doing, but something clinical, and it was, it was a CRA position. But what they noticed about me, was that I started trying to analyze the patient data and I unblinded myself in doing that. And so they were like, okay, well, maybe you need to do something that's a little bit, not that there's, you know, that being a CRA is not intellectually stimulating, but not in alignment with exactly where I was. And so they put me towards regulatory affairs. And so I started helping kind of just general regulatory affairs. Then the guy that was running the product side of things, all the manufacturers and getting the product ready, was retiring. And so they promoted me to that position. And so what was happening at that time was I was getting intellectually stimulated. I was doing well. It had the diversity that I liked where it was ticking the altruistic box and helping people and it's, you know, scientific, it's medical, it's writing, it's reading, it's understanding. And so it was kind of scratching that itch for me, so I didn't go back to school. I well, actually I did, but that's later down the line. But I, I stayed there. That company got bought by Allergan and I left at that point and I went to a medtech startup company and that was my first foray into medtech. So I moved from biotech to medtech. And, you know, some of those things can translate, right? The cultures between biotech and medtech are very different, but a lot of the foundational knowledge of how you think about things can translate. So at that company, I learned more about medtech, but I could apply the biotech lens to it, which I think ultimately helped me from a strategic standpoint in the medtech world. And then I left that company and I started at Proxima, which was the company where I first met you. And I was like employee four there, and I ultimately built their regulatory consulting group and that whole kind of department from me to 15 people and over 200 projects. Loved working there. I did a lot of talking, BD, consulting, all kinds of things. I then started running their clinical department as well, and then I left Proxima and now I work at a AIML company as their VP of clinical and regulatory. So I manage all of their suite of products for global submissions and kind of all the clinical collaborations that are ongoing there. There's a long background, but it's a trajectory and I feel like people feel like they need to know what they're going to do at some point, like early on. And when you go to college, you're like 18, you don't know, and you barely know about what's out there, right? But you feel like 'I should know the answers to all of these things,' and you don't. And sometimes you find yourself in places that you didn't really expect and I know that a lot of people also want to get into regulatory affairs, and it is difficult sometimes to get your foot in the door. It's a competitive type of role largely because it, it is so diverse and stimulating and you have to have a lot of different types of skills to actually be successful in it. But, you know, what I would suggest people do is look for smaller companies to kind of go towards, because those are the types of companies that'll maybe take a chance on you with leadership that helps and guides you through that transition. So when I was running Proxima, I like to hire people kind of earlier in their career because one reason was selfish. You don't have to reteach or get them out of bad habits, right? And then the other part was I just liked kind of, I liked the, the helping and the molding and the growing of them. And it's really nice to see them be successful there or afterwards as they move on into other places. And we have lifelong relationships now. You know, I've left and I still talk to them and they still come and they ask me for advice about things. And so that's really nice. [00:08:42] Lindsey Dinneen: Yeah, that's incredible.,Well, first of all, thank you for sharing a little bit about your background. That was really cool to hear about your career trajectory and so many things popped up for, for me right away. But one of the things that really stood out was this idea-- I love how you talked about the fact that you don't have to know at the very beginning of your career or really, I don't know, even in the middle of it, is this what I'm going to do for the rest of my life? I mean, it's okay to kind of. stumble into a path you didn't expect and see where it leads you. And, I'm curious too, you know, you've had such an interesting, diverse background and you've had all of these different skill sets. So when you first started, I know throughout different places you've been, you've done a lot of business development, but can you share a little bit about the skillsets and the things that you've learned through business development that actually really do translate to... Yeah. [00:09:35] Isabella Schmitt: So, so business development is... so weirdly I had this sort of side thing where I was doing marketing work kind of just as like a side hustle for a bit. And so at Proxima, I really helped with market. So, business development and marketing, particularly for the consulting side of things reported into me as well. So I did a lot of that work, and I think in those cases, business development and marketing, if you're good at it, is all about communication, right? Like, it is about communicating effectively with other human beings, whether that's through talking to them or through writing. And understanding the audience that you're talking to, whether it's talking to them or through writing. So, you know, in a conversation, you get good at reading people, right? Like you can kind of hear what they're saying and you start to learn like, okay, this is their pain point. They're saying this one thing, but what I'm getting from it is this other thing that I know a little bit more about that they're not necessarily picking up on. And so you, you start to be able to take on more of an advisory role, I think? There's different approaches to sales and marketing, right? There's the hard sales approach where it's like sell, sell, sell, which is, there's nothing wrong with that. It's just not my approach to business development and marketing. Mine is much more advise, educate, relationship. What is it that you actually need? How can I meet your needs? And I think that skill set translates really well into regulatory affairs. There's different types of ways you can be involved in regulatory affairs. If you're doing high level strategy type things, you need to have these communication skills. You need to be able to see the forest and the trees and be able to redesign a forest if you need to. But there's also the very by the book administrative side of regulatory affairs where I think these skills probably aren't as necessary and there's nothing wrong with that. Some people really like that sort of structure. I'm not that way. So I really like the strategy communication talking aspects of it. And I think the business development and marketing, the crux of it all is the communication aspect. And that is incredibly important when you're pulling together regulatory submissions, and you're engaging with regulators, you need to understand your stakeholder there, who you're talking to, the audience, what they're interested in what they're not interested in and be able to read that in that instance as well because you want to give them enough information, but not too much information about what it is that they need to understand in order to clear or approve your product. For the people that I would bring in, you know, when they were early in their career, I think them being in a more of a consultative environment was probably beneficial to them in the long term because they had to learn those skills in the context of engaging with clients, right? And so we would do different things, you know, as they were training, I would be on the calls with them, but sometimes we'd do sort of like the mic in the ear thing, but through Teams, I would send them messages like, 'say this, ask them that.' And then I would explain, you know, or if I said something that seemed unexpected, you know, like that was a different direction from the conversation or they expected me to respond to something that I didn't respond to, I would explain it to them afterwards so that they could learn and kind of absorb those skill sets so that they could then take that forward and apply it whether it's with clients or with regulators, or just with teammates, whomever it is moving forward, they would understand the communication aspect is so incredibly important in the strategic side of regulatory affairs. [00:13:38] Lindsey Dinneen: Yeah. Yeah. Yes. Thank you for, for sharing more about that. I can absolutely see the critical importance of the communication skills, being able to translate, but, but building those skills. And honestly, it's probably just great advice across the board. You know, anyone, especially young in their career. Those are the skills to build. [00:13:57] Isabella Schmitt: Yeah. [00:13:58] Lindsey Dinneen: Yeah. [00:13:59] Isabella Schmitt: Yeah. [00:14:00] Lindsey Dinneen: So. [00:14:01] Isabella Schmitt: Nothing, nothing better than relationship building and communicate and clear communication in your personal life, in your professional life, everywhere. So, yeah. And I think, you know, it's interesting too because there are things about my childhood and growing up that also translated into having a skill set associated with communication and understanding people and dynamics that was like a long term training, you know, from being a little kid to now, which maybe not everybody gets and that's okay, but they can learn it. It's something that, it's learned. It's not innate. You can learn it at any point if you're willing. [00:14:48] Lindsey Dinneen: Yeah, I, I love that. So, you know, okay, so now you've had all this incredible experience. You've helped a lot of companies and, you know, regulatory affairs is your jam. What kinds of things do you see that are kind of common, perhaps stumbling blocks for, especially smaller medtech companies that are trying this for the first time and this is their big hurrah and it's really exciting, but what are some things that you see that, that maybe we could help mitigate? [00:15:16] Isabella Schmitt: Mm. Yeah, I think the first things that come to mind and it's kind of like two opposing flavors. One, is... and they're both around pre-subs, right? So pre-subs are the big talking point, I think, all the time, and you will often hear people say like 'just do a pre-sub 100 percent of the time.' I think generally, that's true. There are cases where you don't necessarily need to do a pre sub. But as you go into a pre sub, it's again about communication. You want to make sure that you're not saying something that you can't get yourself out of in the future. So, like, you know, oversharing or oversharing erroneously too. You can share things that maybe are not particularly relevant to what you need to convey but then can cause a flag that sticks in the minds of the reviewers. So you want to go to a pre sub typically with someone who has done them before successfully, and you probably want to find, if you're an innovative company that's doing this for the first time, someone who works with innovative companies a good bit more on the strategy side, even if they're not the one that's writing the pre sub, but that it is overseeing the sort of process with it. Like I said, there's, there's a very administrative side to regulatory affairs too, and there are people who can turn, turn, turn submissions out and that's great. But when you're dealing with an innovative type product, that sort of administrative part of it== it's still important, but it becomes less important-- because you're basically navigating a new landscape and you need someone who has done it before, who can kind of understand how the regulators, whether it's FDA or notified body might think about it so that you can convey the information adequately or answer their questions adequately too. The flip side of it is... so do a pre sub, but do it smartly. The flip side of that is don't do too many pre subs. So one of my friends in the industry and I were just talking recently about ' death by pre sub,' where you do so many pre subs that you've kind of painted yourself into this corner and you maybe don't want to be in that corner and you have to figure out a way to kind of claw yourself out of it. It, it can become very restrictive. So if you go, you know, if you're on pre sub eight, you're probably too far, too far or too deep in at that point. So you want to be smart about the pre-subs and generally speaking, I think that was the first comment, death by pre-subs is usually if you're not being smart about the pre-subs. And then I think people go in maybe without a pre-subs at all thinking that, "Oh, I have a 510 K. It's straightforward." Maybe they're using a predicate. If your predicate's really old, they may have changed their thinking on it, so you probably still want to do a pre-sub even if it seems straightforward. Those are the things that I think are are probably major pitfalls. I'd also say companies not involving someone with regulatory expertise early enough on, so even if you're not engaging with FDA, companies can get kind of stuck in a perpetual loop of product changing and advancement to the point that is detrimental and that a lot of that doesn't actually help in the long run, from a regulatory standpoint, understand your minimal viable product. And then from there, once you understand what that is, right, then you should really start engaging someone who has regulatory expertise. Or maybe you need someone to help you figure out what the minimal viable product is through, you know, some sort of regulatory lens as well. But I wouldn't spend 10 years going through design iterations and all of that before you get someone in to level set with where you are from a regulatory standpoint, [00:19:31] Lindsey Dinneen: Mm hmm. [00:19:32] Isabella Schmitt: And then I think shifting a little bit from regulatory, also involving regulatory and clinical, is understanding the voice of the customer. You design a product, you kind of want to design a product that people want and will use, because you can get through regulatory right? But if nobody wants that product, you've wasted years developing it, and a lot of money, and so getting with whoever the, the end user is going to be and understanding what their actual needs are and having them kind of look and touch and feel the product is, I think, incredibly important, even in the earliest stages, because you don't want to spin your wheels, designing something that nobody ultimately wants or can use. [00:20:19] Lindsey Dinneen: Yeah, absolutely. So design with the end user in mind, talk to the end user in mind, and then talk to an expert such as yourself to really help guide you through that regulatory process. And it sounds like the earlier the better just to start that process going so you have an idea of where you need to head. [00:20:39] Isabella Schmitt: Exactly, yeah. That's exactly right. Yeah. [00:20:41] Lindsey Dinneen: Yeah, excellent. So, you know, you have had such a very cool diverse background and, you know, you've been honored a lot. You're, you know, a Houston Woman to Watch. You have gotten a business award, multiple ones. You just recently got named to MedTech Leading Voices, you know, 100 MedTech Leading Voices. That was really cool. So congratulations. [00:21:02] Isabella Schmitt: LinkedIn's been blowing up from that. I was like, yeah, [00:21:06] Lindsey Dinneen: That's awesome. Yeah. [00:21:07] Isabella Schmitt: I haven't looked at it on my own LinkedIn yet. And it's, I opened it today. I wasn't on it all weekend and I had like 50... [00:21:14] Lindsey Dinneen: Oh! [00:21:14] Isabella Schmitt: ...requests. I was like, what? So yeah. [00:21:17] Lindsey Dinneen: Amazing. Well, congratulations! That's really exciting! [00:21:21] Isabella Schmitt: Yeah. [00:21:21] Lindsey Dinneen: You know, like, just looking back, could 10 year old Isabella have ever anticipated this is where you would be right now? [00:21:29] Isabella Schmitt: No. Well, you know, not exactly, but I was Student of the Year when I was 10, so maybe that was an early hint, I guess. [00:21:42] Lindsey Dinneen: I love it. [00:21:43] Isabella Schmitt: Yeah. [00:21:44] Lindsey Dinneen: Yeah. [00:21:45] Isabella Schmitt: Yeah, 10 year old Isabella I don't know. 10 was a weird age. [00:21:51] Lindsey Dinneen: Yeah. Fair enough. Fair enough. [00:21:54] Isabella Schmitt: I definitely wouldn't have seen myself in this industry and even, you know, 18 year old Isabella wouldn't have seen myself, because I didn't know it existed, [00:22:03] Lindsey Dinneen: Right. [00:22:04] Isabella Schmitt: But, you know, being highly on the business side of things too, because regulatory is very deeply integrated with all should be with all aspects of a product, right? And so I have to understand the voice of customer and I have to understand if there's a market for this and I have to understand the engineering and be able to translate all that information and, you know, and then on the other side of it with Proxima, I built the actual business. So, you know, I had to design pricing strategy and marketing stuff. And so I never really saw myself being so heavily involved in the business world and that may have like honestly come from, not to get all political or whatever, but like a lens of sort of my vision of business person was male, you know, and so I just didn't have a lot of exposure to women in, in business roles and I don't, I don't think I ever had imposter syndrome because I always felt pretty confident in my abilities. I felt more like the world of business was male dominated, which it largely probably still is. But, but I think that kind of maybe held me from having that vision. And I mean, surgeons are male dominated too, but I was thinking I was going to be a surgeon. So, so, but I also had a vision of the business world as being more like Wall Street kind of world. And you grow up, you know, and you learn new things and get exposed to new people. I'm very thankful for the people that I have met who have given me opportunities to, to shine, I guess who have trusted me, like Kevin with Proxima trusted me to build the department. The company that I work for now basically trusts me to do all the regulatory stuff. Obviously, hundreds of clients have trusted me with their regulatory, with their babies. So it's one of those things where it's a combination of your own aptitude, but also other people. And, and I think for me, and that's why I wanted to also bring in, you know, green people who are coming new into the industry, to give those people opportunities to live up to their potential too, because a lot of it is having the opportunity and having someone trust you in order to, to show what you can do or can't do, I guess, but you learn either way, right? Failures are learning opportunities too. So. [00:24:40] Lindsey Dinneen: Yeah. Well, I love that because you, you saw people, you know, 'cause sometimes it feels, especially as a job seeker, if you're young, or you don't have the industry experience, it just feels so invisible. So I love the fact that you were willing to do that. And then mentorship sounds like a really strong pull for you. Like, you very much care about that and helping the next generation of folks... [00:25:02] Isabella Schmitt: Yeah, yeah. [00:25:02] Lindsey Dinneen: ...find their footing too. So I love that. [00:25:05] Isabella Schmitt: I, I love doing that. And I was teaching at Rice. I would teach a lecture a semester at Rice when I was at Proxima, maybe I'm going to do it now, I don't know. And then A&M a little bit too, and so even just kind of meeting students, I just, I like to give people opportunities, so if people are listening to this and they want to understand how to get into regulatory affairs or really anything, I am happy to have a conversation. Lindsey will tell you that I might reschedule it, but I will have the conversation. [00:25:40] Lindsey Dinneen: I can attest to this. She will, she will. Absolutely. [00:25:43] Isabella Schmitt: I do want to do it. It's just, yeah. [00:25:49] Lindsey Dinneen: MedTech has become sort of, at least it sounds like your calling, for lack of a better word. And so I'm curious, you know, you are obviously very passionate. You are one of the leading voices in the industry. You are a thought leader. Along the way have there been moments where you just thought, "Wow, this really cinches it for me. I am in the right place at the right time doing the right thing." [00:26:11] Isabella Schmitt: I mean, I think, in general, I feel that way. I, I'm the type of person who, though, is kind of always looking to grow and advance and more and more and more. And so I think it's, it's always kind of a learning experience. I think I will stay in this industry till I die, but for for a long time and it kind of just like, it clicks in my brain. Like, it just, it sort of makes sense with how my brain works. But, you know, I have also expanded a little bit into AI kind of generally speaking as well. So, I work at an AI company now and I've worked with many AI products before. But I also am in a master's for AI, and I've been doing some policy work with it. So I, I try to, I try to go deep and broad at the same time, which I think is hard and maybe tends towards workaholism, workaholicism? But, but it keeps me stimulated and feeling like I'm productive and moving forward. And so, you know, I, I guess, to answer your question succinctly, I do think I've found a place that I really love. I think that I will continuously look to expand and grow, just how I am, whether that's in specific with regulatory affairs or whether it's spinning off another consulting company or whatever, you know, my own product company one day, whatever it might be. I think this space is what I like. And I, I like growth personally, and I like growing people and I like growing businesses. So I think all of that, I guess if there was a moment, honestly, Proxima. My experience at Proxima with growing, growing there, myself, the company, clients, employees, marketing, whatever it was that, that probably sealed the deal for me staying and not kind of looking to do something else. There was a short stint where I was very confused again before I started at Proxima. I was like, "I don't know if this is right for me." I was thinking about leaving the industry and going and doing psychology and all of that. And, I got the job at Proxima, it just kind of checked everything for me. And so I think that, that, you know, if you're a person that likes a lot of diversity, I think getting into a strategic regulatory affairs role, particularly if you're able to work with multiple companies is, is the sweet spot. But yeah, that was one of the best places I've ever worked, one of the best experiences I've ever had. [00:29:02] Lindsey Dinneen: That's incredible. Well, great. I'm so glad and thank you for sharing about that experience. Yeah, that's wonderful. So, okay, pivoting the conversation a little bit just for fun. Imagine that you were to be offered a million dollars to teach a master class on anything you want. It can be in your industry, doesn't have to be at all. What would you teach? [00:29:21] Isabella Schmitt: would I would probably teach AI policy with specific towards regulated industries. So meaning, obviously, medtech, biotech to o, aviation, aerospace defense. So I kind of want to take it, sort of a broad approach, of how we think about regulatory with regards to AI, and the differences in regulating that type of product versus more standard types of products. So, that would probably be what I would would like to do if I were teaching a master course. [00:30:06] Lindsey Dinneen: That sounds incredible and very needed, very timely. [00:30:10] Isabella Schmitt: Yeah, [00:30:11] Lindsey Dinneen: Yeah. Excellent. How do you wish to be remembered after you leave this world? [00:30:18] Isabella Schmitt: That's a big question. So, and it's a tough question. I want to have made an impact on the industry, on people's lives, on an industry because, you know, with AI, it could be multiple industries, I guess, too. Probably sticking closely with medtech. It's what I like, and it feels like the best again, like value kind of. I think if I were to like make up this dream scenario of where I ended up, eventually I would have my own product company. I would sell that off. I would probably start another consulting company that I helped people with still. And then I would do like philanthropic things with money. And largely focused probably on pediatric type devices, rare diseases and conditions, and probably veterinary medicine, which those areas I don't think get enough attention. I have a lot of experience with with pediatrics in particular and I think I would like to be able to work closely with getting more of those products to market. They're, you know, difficult funding opportunities there because such a small, still large burden, but such a small group of patients that the ROI is not typical of what you would see, you know, a lot of VCs investing in. So something like that, I think, and being remembered for those, those things, I think, would be great to me. [00:31:50] Lindsey Dinneen: Yeah. [00:31:51] Isabella Schmitt: Also, if I influenced policy in some kind of way that was fundamental, I think that would be pretty cool too. [00:31:57] Lindsey Dinneen: Absolutely. Yeah. Very cool. And then final question. What is one thing that makes you smile every time you see or think about it? [00:32:06] Isabella Schmitt: Oh, that's a good question. Not work related or work related? [00:32:10] Lindsey Dinneen: Oh, both, either. [00:32:12] Isabella Schmitt: I, probably my dogs would be, that's an easy not work related answer, although sometimes they drive me nuts too. So there's a spectrum of emotion with them, but generally dogs. Dogs are just the best. I'm, I'm a dog person. They're just so loving and understanding. Work wise, obviously, anytime I have a successful submission, or there's an exit, any success, it always makes me smile. So, and then, you know, I also really like-- I haven't been to many over the last year, just with the change and the dynamics of my world-- I love networking events. So, like, thinking about networking events, I just, I really enjoy those types of interactions. They've always been really fun. I've been thinking about going to them just for fun, just to see people again because it's been a while. And I used to love, like, my favorite thing was Medtech Innovator. So I'm answering this question, and I'm thinking of the answers I'm talking about. So MedTech Innovator, I love MedTech Innovator. It was almost like when you're a kid, and you go, and you have the summer off, and you don't see anybody or any of your friends, and then you go back to school, and you're sort of excited to see them again. That's what that community felt like, really to know the people there so well. So MedTech Innovator, that's my answer. [00:33:35] Lindsey Dinneen: I love it. Great answer. Great answer. Fantastic. Well, oh my word, this has been so much fun. Thank you so much for taking some time today just to share with me about your life and your experience and all the wonderful things that you're bringing to the world. I just really appreciate it. And, just thank you for your time. [00:33:56] Isabella Schmitt: 'Course, thanks for having me. [00:33:58] Lindsey Dinneen: Yeah, and we are so honored to be making a donation on your behalf as a thank you for your time today to the Polaris Project, which is a non governmental organization that works to combat and prevent sex and labor trafficking in North America. So thank you for choosing that organization to support, and I just wish you the most continued success as you continue to work to change lives for a better world. And just also thanks to our listeners for tuning in. And if you're feeling as inspired as I am, I'd love it if you'd share this episode with a colleague or two and we'll catch you next time. [00:34:36] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Steven Collens, CEO of MATTER, an incubator & innovation hub, discusses his journey and the impactful work MATTER does in healthcare innovation. Steven shares his transition from Abbott Labs and Capitol Hill to leading MATTER, emphasizing the importance of collaboration in accelerating healthcare advancements. He provides insights on how MATTER supports both startups and large companies and also reflects on personal moments that confirm his career path and the strengths that help him lead in the industry. Guest links: https://matter.health   Charity supported: Innovation Development Institute Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 047 - Steven Collens [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I'm delighted to introduce you to my guest, Steven Collens. Steven is the CEO of MATTER, the premier healthcare incubator and innovation hub. MATTER opened in February 2015 and nurtures entrepreneurs and innovators building next generation health IT, medical device, diagnostic, and biopharma technologies. MATTER has worked with more than a thousand healthcare technology ventures and the company partners with dozens of industry leading companies, health systems, and universities. Steven holds an MBA from Northwestern University's Kellogg School of Management and a BA from Washington University in St. Louis. He chairs the board of Hubbard Street Dance Chicago and serves on the boards of 1871 and the Chicago High School for the Arts. He is a member of Chicago Next, the Chicago Mayor's Council of Technology and Innovation, a Leadership Greater Chicago Fellow, and a member of the Economic Club of Chicago and the Commercial Club of Chicago. Well, thank you so much for joining us, Steven. I'm so excited to be here talking with you today. [00:01:57] Steven Collens: It's a pleasure to be here. Thanks for having me. [00:01:59] Lindsey Dinneen: Of course! Well, I would love if you would start off by sharing a little bit about yourself, your background, and maybe what led you to MedTech. [00:02:09] Steven Collens: So myself, I guess it's all intertwined together, so after business school, I went to work at Abbott and I was at Abbott labs for about 10 years. That was my introduction into healthcare and medical technologies of any sort. And after that, I went to work at an investment firm. On behalf of them, started an incubator that was not focused on healthcare, and then had the opportunity to do what ultimately became MATTER, which was starting something that could really help accelerate the pace of change of healthcare and figuring out how to combine elements and do that. And our basic thesis at MATTER is that collaboration is the way to accelerate the pace of change of health care. And so MATTER is structured as a not for profit entity. We functionally incubate startup companies. They are different types of technology. It's primarily software and devices. They're all over the world. It's a membership model and we've got a suite of resources to help them at different stages of growth. And then on the other side of it, we work with big companies, so big life sciences companies, health systems, insurance companies, and we help them innovate more effectively. We help them collaborate with entrepreneurs. We help them harness innovation in ways that they're otherwise not necessarily wired to do. And by putting all of that together you know, almost 10 years in, we like to think and certainly hope that we're helping make a change in healthcare. [00:03:40] Lindsey Dinneen: Yeah, I know you are and I know that by your mission and the way that you go about your organization, and it's very exciting to see how the companies that have come through the program have continued to thrive. And I was wondering if any of those, particularly companies that you've worked with, really stand out to you in terms of making a huge difference in the way that you could come alongside them and work with them to make that difference. [00:04:09] Steven Collens: Yes, for sure. There are companies where people come in and they come from the healthcare industry and they know a lot, and the ways that we help them are different than companies where the entrepreneurs come in and they're not necessarily from the industry. And we love working with all of them. We will work with entrepreneurs, but we don't have anywhere near the level of screening that a venture capital firm would do, where it's a more of a democratized approach. We look for companies that are trying to solve something that's meaningful in healthcare. So if they are successful, they will help advance healthcare in a direction that's meaningful. We look for entrepreneurs and teams that give us some reason to believe they can be successful. Could be prior success, it could be that we're just so impressed by how smart they are. It could be their passion. It could be some combination of a variety of things. It could be somebody else has invested in them already. And like, "Well, we know they did a lot of diligence." And then the only other criteria is like people we want to work with and be around and that are going to increase the general level of joy and happiness in our environment. And so, there's one guy who met his co founder at MATTER. He's more of the business guy. The co founder was more of the inventor, scientist guy and, you know, it's an example of a company that's solving one of these problems that if you're not in healthcare, you just sort of scratch your head as to, which in healthcare, there's like an endless number of these problems where if you look at it with a more rational lens or from an outside perspective, you're like, "Huh, that's how healthcare works? I don't, that's so strange." It's a device for when a surgeon is putting screws into a bone, the way that they need like a, some sort of a depth gauge to determine what size screw to use. And it's like a reusable thing that they all use. It's totally analog. It's not a sophisticated piece of technology. They learn how to use it when they're doing their training and they just keep using it. And obviously they wash it and sterilize it, but you know, it's not ideal for a lot of reasons. And so this company developed a digital and disposable version that is more accurate, more sanitary, obviously, you know, we don't always want to advocate for things that are disposable versus reusable, but in this case, having this combination of accuracy and not dealing with any issues around sterilization and cleanliness, is a big improvement. And, it's a medical device, took a couple of years to develop. Again, he met his co founder at MATTER. He met a lot of other people who provided different guidance and advice and support and financing through MATTER. And so now the products in market and doing great, and they're working on other other products. So that's one of the companies that, that pops to mind. I mean, I, we could use up the entire time talking about different companies, but I'll pause there. [00:07:27] Lindsey Dinneen: Yeah, I'm sure that we could. So, at the beginning, you talked about collaboration and how that can be the key to success for these companies that you're working with. And I'm wondering, I feel very strongly that collaboration is the key in so many ways to amplify success, and even to get to a point of success, because we don't know everything ourselves, but how do you get past-- and or help up maybe some of the companies that you work with-- get past sometimes a more competitive mindset where it's hard because you're very protective of your IP, you're very protective of your process and your business. So how do you help companies understand the value of collaboration and what we can do together to rise together? [00:08:11] Steven Collens: I think it's such an interesting question, and I'll take you all the way back to when we first were creating MATTER. And so I had just recently built this other incubator, not focused on healthcare, more like web mobile tech stuff at the time. And I was working with the same architecture firm and real estate people. And one of the things that we were trying to figure out, because we knew it needed to be different, for that because healthcare is different. It's a different set of people. It's different archetypes. In some cases, it's even different motivations. It's just, it's a different milieu. And one of the things that we spent a lot of time trying to figure out was, IP is so much more important when you're dealing with medtech as compared to your average software company, which is more about speed of execution. And I mean, it's about a lot of things, but it's, in the early days of most software companies, IP isn't top of mind. Whereas in the early days of most medtech companies, IP is top of mind. And how is that going to work? Are people going to be collaborative? And so we spent a lot of time, we talked to lots of people, tried to figure out how to deal, it turns out it like doesn't even matter. For 95 percent of the entrepreneurs out there, obviously they care about their IP, but there's collaboration in two veins. One is, other entrepreneurs are not doing the exact same thing. They're almost never directly competitive. Knock on wood, we've supported a thousand companies who've been around for 10 years, and we have not had one entrepreneur steal another entrepreneur's technology and try to run with it. God forbid that we land in that stage. The more complicated question is in dealing with the large players in the industry. And so on that dimension, some of the entrepreneurs are reasonably a little bit careful. Our basic thesis is that if you are building a new technology that you're trying to put into the healthcare system, you need to know more than you probably think that you need to know about how that system works, how things get paid for workflow solutions, decision making processes. It's just, there's so many areas of healthcare. Even if you've been in healthcare, unless you're just exactly in the space that you know inside out and backwards and forwards, there are so many areas and aspects of healthcare that are not intuitive, that frankly, if you were coming up with a design system, you'd never design something that way, because this doesn't make a lot of sense. But that's how it works. And you need to understand all of that if you're an entrepreneur in order to be successful. And so, one of the ways that we help with that, we've got lots of mentors and executives and residents and folks, but we also have lots of relationships across the industry with payers and with providers and with medtech companies and pharma companies and software companies, big ones. And they are immense sources of knowledge and resources and understanding. We have actually had one case where a large company met with one of our startups that was not really a medtech company. It was not a regulated device and they didn't have any IP. Just had an idea, they had a prototype of it, and the company basically went and did it on their own and it was really quite disappointing. And so we did not bring them back for anything. And, that was disappointing. So far, it's a one in 1000 events and that still more than we want to have, and hopefully we won't have that again. And we spend a lot of time with these large companies, and for the most part, they understand what the dynamic is, and they come and work with us for multiple reasons. One of those reasons is that generally large companies cannot innovate as fast as technology is evolving. And so if they want to capitalize on new and emerging developments, new and emerging technologies, one of the best ways to do that is find entrepreneurs to work with, maybe eventually by the company, it depends on the dynamics could be, you make an investment, could be you just collaborate, could be you buy it. I mean, there's all sorts of different structures, but that is a tried and true way of accelerating innovation within a large company to advance goals. The challenge is that large companies don't necessarily know how to find the right entrepreneurs. Once they find them, they don't necessarily know which ones to work with. It's not as straightforward as picking Deloitte or Accenture or something with a massive track record. And so it's more complicated than that. And then once they do decide to work with one, working with an early stage startup is a very different experience than working with a very large company. And a lot of large companies just aren't very good at that. And so that's, we help them. And again, 99. 9 percent of the time so far, it's been successful. [00:13:39] Lindsey Dinneen: Yeah. Well, thank you for sharing about that and your philosophy behind it. And also, I appreciate you being willing to share that one story because it's, you know, even though of course we wish that would not happen and never did happen, but the idea that you can still be successful in collaboration and there's still so much opportunity for mutual growth and learning. And yeah, you might have the bad actor every once in a while, but for the most part, to your point, 99. 9 percent of people really have that spirit of collaboration, which is great. So now you come into MedTech from a different background than some other folks. And so I was wondering if you might share a little bit about your early career and how that actually helps you now, because those skills I'm sure translate a little bit, but I would just be curious to know a little bit more about how that has played into your career. [00:14:35] Steven Collens: Yeah, well, my early career, so I in college, I studied political science and French literature, like the farthest thing from, I walk by the engineering building and be like, "I don't, I have no idea what's going on in there. I'm going to go back to my French literature class where I feel comfortable." And then I went to work on Capitol Hill. So I, I was an aide to a Senator for almost six years. Spent most of that time working on education policy and transportation policy, loved it, but sort of looked around at a certain point and there weren't a lot of people where I, I looked and I said, " In 20 years, I want to be like that." And it wasn't obvious to me what my longer term trajectory is. I didn't have the faintest idea what I wanted my longer term trajectory to be. So, you know, I sort of, tried and true strategy went to grad school. So that's when I went to business school and I ended up at Abbott because, when I came out of business school Abbott at the time had a kidney business, a renal business, and they made a drug for dialysis patients. At the time it was a 300 million or so product and Medicare, and this was a long time ago, the structure of how dialysis treatments get paid, get are paid for as different now than it was then. But at the time, this drug had was in the process of replacing a generic version, which Abbott also sold and it had been engineered and tweaked in a way that ultimately some researchers at Harvard that we had nothing to do with showed that it had a survival benefit compared to the old one. But before we, before they showed up on our doorstep with this New England Journal of Medicine study that they were, it hadn't been published yet, but they said, "Hey, just FYI. We're, we've done this massive analysis and the New England Journal of Medicine is going to be publishing it and your drug prolongs life and there's a survival benefit based on all these." And we're like, "We thought that, but thank you for proving it." Before that, Medicare looked at these two drugs and they said, "These are basically the same thing. One of them is way more expensive than the generic one. And we want doctors to stop prescribing that because we don't see the evidence." And, you know, obviously we believed in our own data and we showed it, but they did whatever analysis they did and they came to a different conclusion. And so they were trying out these different tools that they've never used before, because Medicare doesn't have the right, the ability today, and certainly not back then even less, but not today, to dictate what doctors can use and what they can't use. And they were trying out these new tools to effectively get around that and force doctors to use the generic. And so the business unit within Abbott was looking for a couple of people who had a mix of business and an understanding of politics and policy and how Washington works, and so I joined that team and focused for the first year and a half or two years on trying to solve this problem that Medicare was trying to essentially put this business out of business. And then after we've solved that, I had a more traditional marketing job and then I kind of moved around within the company. Some of those jobs I had within the company are directly tied back to the experience I had in Washington. So I wouldn't have gotten that job, first of all, had I not had that Washington experience. After my sort of stint as a normal product marketer I went and wrote speeches for the CEO, which I was only qualified to do because I'd written a thousand speeches when I was in Washington. And so that moved me then into sort of a role around messaging and communications for the company, which I was in for a while in different roles. Fast forward, when I left Abbott, I went and I joined this investment firm. I was effectively the chief of staff to the to the guy who was running or one of the two guys who was running the firm. I certainly wouldn't have, without that foundation from what I learned in DC, which was partly about messaging and communications and policy and things like that, but also it was a really strong foundation in two other things. One of just understanding how the world works and how people and groups interact with each other to advance their goals and how that happens. And also how to mobilize other people and organizations to help accomplish one's goals. And so that was part of what fed into me getting that job at the investment firm. Building MATTER, and even the incubator before, I approached as very much a listening exercise to the community. Now I would say it was very much following a design thinking or a lean startup or those sorts of things where it's, we'd come up with some ideas and then go bounce it off the market and see what entrepreneurs or other stakeholders wanted. And they don't call it that in politics, but I certainly learned how to do that on Capitol Hill, because in order to get anything done, you need a lot of different stakeholders to both be bought into what you're doing. In some cases, you need them to think it's their idea. And so, so certainly that was very helpful and continues to be really helpful in building and then operating and running MATTER. [00:20:33] Lindsey Dinneen: Yeah. Yeah. Well, thank you for sharing a little bit more about your background and how it has actually aided you getting a few different of the roles that you've had. I think there's always, if you look back, maybe some purpose to the meandering that sometimes happens where you go, "Oh, okay, here I am in MedTech!" And maybe didn't expect it, but I love how it worked out. So are there any moments that stand out to you as confirming along your career, maybe especially with MATTER, but even beforehand, as confirming that "I am in the right place at the right time in the right industry?" [00:21:13] Steven Collens: Yes. I mean, there's so many. When I left the firm to, and then was starting MATTER, I assumed I would do this for two or three years. I kind of get it up and running and everything. And then I go do something different. I'm still here, just about 10 years later, which sounds to me like a really long time. And I, so I think about, and I have for probably the last five or six years, regularly think about, "Is this really what I want to be doing?" I've been doing this for a long time and, is this really the direction I want to go? And so there's a lot of things that, that keep me engaged and enthusiastic about what I'm doing. So one of those is, it's probably hyperbolic to say every day, but every week, the kinds of people I get to work with and the kinds of things that they are thinking about and trying to solve, I find very energizing. I love working with entrepreneurs. They, for the most part, are people where their passions are aligned very closely with what it is that they're doing and building. If you want to build a successful startup, you have to be all in. You have to just be passionate about it and committed to it and dedicated to it. And you're giving a part of your life to building this thing and this company. I find that archetype just really energizing to be around, and to be able to help folks like that, I find endlessly enjoyable and and satisfying. And on the other side of what we do, the people within these large companies that we work with are, almost by definition, trying to push the company in ways that it's not already going. They're trying to push boundaries. They're trying to change things because they are driven by this mission. It's much easier if you're in a big company to just go with the flow. And a lot of people do that. And you need a lot of people to do that in a large company. The things that large companies do really well, they don't do really well because every single person in the company is trying to constantly push the boundaries and innovate and change things. The company couldn't work like that. But there's a subset of people who are trying to do that and they're trying to push harder. And they're trying to go in different directions and experiment and try things, and we get to help them. And I also find that endlessly engaging and interesting and rewarding. A couple of years ago I did a-- I love personality tests and all these different kinds of things. And so I did one, it wasn't really a personality test, but it was a fairly detailed exercise of, "Are you in the right role in the right industry and are you doing the thing you should be doing?" And I went through this whole thing and what came back was a resounding "yes" that when you just, when you look at it in a whole bunch of different dimensions, this really fits. Is it the only thing that I could be doing that? Of course not. Would I be just as happy and in other roles? For sure. But I get a lot of satisfaction and joy from the work that we're able to do, from the team that I'm able to do it with, and the people that we're able to help. [00:24:43] Lindsey Dinneen: Yeah. Yeah. That's incredible. Thank you for sharing about that. So pivoting the conversation just for fun, imagine that you were to be offered a million dollars to teach a masterclass on anything you want. It can be in your industry, but it doesn't have to be. What would you choose to teach? [00:25:03] Steven Collens: Wow. A million dollars to teach a class on anything I want. There's some interesting triangulation of of what I'm actually capable of doing, but I guess if I had a million dollars to do it, I could become a lot better at something. It's an interesting way of asking about passions and things like that. It would probably be something around hiking and outdoors and camping and functioning in nature, which is how I spend a lot of my free time. But I'd also would love to teach a masterclass on healthcare innovation and healthcare technology. I think more people would probably benefit from that than a class on hiking. But I like to think that I've learned a lot over the last 10 years about what makes healthcare innovations go farther, go faster and be successful, even if they're coming from different lenses. They're coming from large companies, if they're coming from entrepreneurs, if they're coming... and our healthcare system just needs an endless amount of innovation and technological advancement and, you name it, it needs everything. And so if I could impart some of what I hope I've learned over the last 10 years doing this, plus 10 years at Abbott labs and other things, but I would love to do that. And it would probably be more useful than a class on the outdoors. [00:26:36] Lindsey Dinneen: Okay, well I think both sound like good classes, so we can do both. It can be a yes and! [00:26:42] Steven Collens: Excellent. [00:26:43] Lindsey Dinneen: Alright, and how do you wish to be remembered after you leave this world? [00:26:48] Steven Collens: You know, I'm not a religious person, but one of the 613 rules in the Old Testament is basically like a catch all for other things, but if you take aside from all of the prescriptive, very specific ones, there's one that is just, "be holy." And the point of it is that, in this case, God, writes all of these rules about how people are supposed to act in order to create a functioning society. But the people will always get around that if given the opportunity. It doesn't matter how many rules you have. It doesn't matter how prescriptive they are. People have the innate ability, and a lot of people will, figure out work arounds and ways to get around it. And so this one is supposed to be the catch all for that. Again, I'm not a religious scholar. I'm not even religious, but this is my understanding, and I love this as a concept. And so by being holy, you're supposed to think about what is the intention of all of the different rules or the rules that are tangential or this, what am I trying to accomplish? And is my behavior and action going to contribute to the kind of world that I think that I want to live in. And so, I would love to be remembered for somebody who is acting that way. And that's hopefully people see that or look back, the kinds of decisions I've made, the kinds of things I've done, the kinds of actions I've taken, and see it as a form of being holy in that sense. [00:28:44] Lindsey Dinneen: I love that. That's a very thoughtful answer. Thank you for expounding on that too. I really appreciate that. And final question, what is one thing that makes you smile every time you see or think about it? [00:28:58] Steven Collens: I mean, every time is a challenge. Most of the time, our six year old kid. Probably dog, most of the time, maybe even... the dog's a lot less complicated than the six year old. And so the level of feelings are not as quite as depth, but also it's a more of a pure, she's just a sweet, lovable dog. So maybe it's the dog. [00:29:25] Lindsey Dinneen: I love it. Dogs are wonderful. [00:29:28] Steven Collens: I don't mean to say that I love the dog more than the kid. It's just very specifically your question about. [00:29:35] Lindsey Dinneen: it is specific. [00:29:37] Steven Collens: Yeah. [00:29:38] Lindsey Dinneen: I love that. I love that. Great answer. Well, I just really appreciate your time today. Thank you so much for joining me. Thank you for sharing about your background, your career, MATTER and how you are encouraging people to do things that matter. I really appreciate the way that you have this collaborative spirit and are helping to propel these companies to success. So thank you for all of the work you're doing. Thank you for joining me. And we just wish you the most continued success as you work to change lives for a better world. [00:30:10] Steven Collens: Well, and thank you so much for having me. It's been a pleasure. [00:30:13] Lindsey Dinneen: Excellent. And thank you also to our listeners for tuning in. And if you're feeling as inspired as I am at the moment, I would love it if you would share this episode with a colleague or two, and we will catch you next time. [00:30:28] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Justin Bantuelle (COO) and Michael Roberts (CMO) of Health Connective discuss the company's role in supporting medtech firms by developing custom web applications for surgical planning, post-operative reviews, and other solutions. Justin and Michael share their personal journeys into medtech, highlighting the rewarding experience of contributing to life-saving technologies. The conversation touches on common challenges in medtech like security and user experience, emphasizing the importance of empathy, active listening, and adaptability in solving complex problems.    Guest links: https://www.healthconnectivetech.com/ Charity supported: Save the Children Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 047 - Justin Bantuelle & Michael Roberts [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.  Welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and I'm so excited to introduce you to my guests today. Justin Bantuelle and Michael Roberts. Justin is the Chief Operations Officer and Michael is the Chief Marketing Officer for Health Connective. Both have been working with the company for more than 10 years. Health Connective supports web application development for medtech companies, including online interfaces for pre surgical planning and post operative review, streamlined systems for customer orders, and training portals. They understand that every company's needs are unique, and your solution should be too. Well, welcome, Justin and Michael. I am so excited to have you guys today. Thanks for joining me. [00:01:35] Justin Bantuelle: Yeah. Thank you for having us. [00:01:36] Michael Roberts: Very excited to be here. Thank you. [00:01:38] Lindsey Dinneen: Awesome. Awesome. Well, I would love if you wouldn't mind starting off by just sharing a little bit about your background, maybe what led you to medtech and your heart for it. So I'll start with you, Justin. [00:01:51] Justin Bantuelle: Sure. It was, I kind of fell into it, I guess, initially, which I think on the tech side, probably a lot of people end up doing that. I had a computer science background. I got my bachelor's degree and I started at the company we're at now, Health Connective, out of college. And I've been there for 16, 17 years or something, but we were healthcare focused. And so they needed web development skills. I was a programmer, and that's how I started, but I've learned a tremendous amount since then. So I think coming from that technical angle, this is like where I fell into it. And I've moved up to the company. I manage a lot of people. I manage a lot of client interactions, help build systems that support medical devices, robots, things like that. So I've gathered a tremendous amount of information about this field as a result of that. And I've stuck with it cause it has been very rewarding. It's something that matters so much to so many people. You see the real Impact that it makes when you help get these products to market. And you see all the research studies that show how much this is transforming these different fields of care. And then just, I think we all have personal experiences with these healthcare systems and the challenges people face, the uncertainties about it. Just talking to like my parents or to friends who know less about the sector and just that I have any kind of insight into it helps assuage fears. And yeah, it just, it matters. And that's very rewarding. [00:03:18] Lindsey Dinneen: Yeah, absolutely. Thank you. [00:03:20] Michael Roberts: Yeah. I did not set out necessarily to be in medtech as well. Like Justin, long story short, when I got into marketing, I was working more in the hospitality industry, hotels, restaurants, all that kind of stuff. Decided I didn't want to do that anymore and thought, "Where can I get as far away from the hospitality industry as possible?" And so, the funny thing there was some non compete things that I had to deal with from my previous employer. And so I was literally looking for a place that had no overlap with the previous company that I'd worked with as a marketer. And so I found the company, found Health Connective, and jumped into it and try to bring in the same skill sets. I'll just do some of the SEO and I'll do some digital advertising and some of that kind of stuff. And some of that worked and some of it was just so drastically different, right? Like this is such a different experience for people. So my first thing that I worked on here at the company was working with orthopedic physicians, helping them out with their marketing. And it was very similar in small business marketing in a lot of ways, but again, drastically different in so many ways. And then one of the first things that I ended up working on within the first few years was working with Olympus on a campaign that they were doing about raising awareness around gastroenterology around going to get your colon checked and all of that fun kind of stuff.  I have a family member that has a Crohn's disease. And so this was something that very quickly became like, "Oh, this is a part of what we're all experiencing." I was able to go and ask people questions at Olympus. We went to Digestive Disease Week, which I had no idea was a thing, went there and I got to meet with the Crohn's and Colitis Foundation, just purely as a dad. Being there and just going like, "Can you just tell me how to help my daughter, how to help understand it?" So that was kind of the thing that really clicked, "This is where I need to be. This is what I need to be doing." Because so many of us are experiencing something like this somewhere in our family, whether it's us as patients, family members, whomever. So that was kind of the big click moment for me. [00:05:20] Lindsey Dinneen: Awesome. Wow. Yeah, that's powerful. Thank you for sharing that. So could you tell us a little bit about the company and maybe also a little bit about your goals as it continues to grow.? [00:05:33] Michael Roberts: Yeah, so, you know, we, as a company, we're out there to help MedTech companies with a couple of different kinds of things. So we end up helping the product and sort of R&D side of things. And that may be with robotic devices, if there's different types of data coming off of the device that they want to be able to show back to the different physicians, the different people that are involved with the procedure, that's the type of work that we do. And I'm super glossing that over and saying that very quickly, but there's a lot of different people that we share this information with that comes off the robot, everybody from physicians to engineers, to field service teams, all those different kinds of folks. And the goal there is just, "Hey, you're obtaining an immense amount of data out of every single procedure. What can you do with that data? How can we help you better utilize that information and improve outcomes and do all those kinds of things?" so that kind of product development and like I said, R&D side of things that's kind of where we fit. And then on the marketing side I, I kind of refer to it as like the, "Wouldn't it be cool if?" kind of group. It's like, "Wouldn't it be cool if this process that we had didn't suck? That would be awesome. How could we get somebody to help us with that?" So anything from ordering online kinds of processes where, because it's not as simple as just setting up an e commerce solution and just letting it run, you have to have different pricing for every sector and you have to have different contracts with everybody and all of those kinds of things. We can marry a lot of that messy data and make it a seamless experience for people so it doesn't suck. And so that's what we're hoping for. And then also like, "Wouldn't it be cool if these things could be that much better?" So a lot of efficiencies, a lot of things where again, these systems don't natively talk to one another. How can I get my CRM and all of these other unique data sources that I have to actually cooperate with one another. So, that's the kind of stuff that we set out to do. Again, I'm saying it super simply as opposed to how Justin would be able to define it. But, but those are the things that we're setting out to do for people is improve that customer experience and then get better data coming back from their procedures, that sort of thing. [00:07:41] Lindsey Dinneen: Yeah. Well, I would love to dive a little bit more into what does it look like when somebody starts working with you? How do you go from, you know, taking them through lead all the way to your day to day? What does that look like? [00:07:57] Michael Roberts: Yeah, I'll start the conversation. And then Justin, 'cause Justin takes over at a certain point and I just go, "Hey, let me know if you need anything." But a lot of it is, these kinds of things are very trust driven, right? So we have a lot of messaging out there. We have a podcast, we have advertising that we're doing, we're going to be at a few different trade shows through the rest of 2024, figuring out which ones to be at for next year, but a lot of it does come down to relationships. So somebody has introduced us. We've started having those kinds of conversations because any of these kinds of things that you're talking about there, there's kind of big, messy problems that aren't easy to fix. They aren't something that you just sign off on quickly that's a 5, 000 a month subscription and off you go. It's a bigger, more thought out process. So a lot of it is that sort of process of, "Hey, let's get to know one another. And then really digging into what problem are you trying to solve?" Everything that we do is a custom solution. So it's not, you don't have to use XYZ systems in order for us to work with you. We can be very flexible on that, but then, so we really get into that kind of problem definition stage, and then Justin, I'll let you kind of take it from there once we get into the problem itself. [00:09:05] Justin Bantuelle: Sure. Yeah. I mean, the initial touch point with it is really just listening and reassuring that, "I've heard your problem before something similar to it. Okay, you have these different technologies. These are the things that are unique about what you're trying to do in this space. And here's how I can craft a solution for you." So it's a lot of listening, helping them along the process of requirements gathering, usually this part of it, this front end data visualization after the fact for a lot of medical device, I find that's not their core competency. Their core competency is the device itself. They've built the device. The device works very well. It achieves something and it solves a problem in the medical space, but then there's all this stuff you have to do after the fact. And so it's like, "Great, this work, the procedure is amazing. And now there's all these things that we need to take action with," and that's where we kind of step in and provide that end of it. And we augment their teams that they already have. They have several very technical people. They've got brilliant engineers, they probably got brilliant developers involved in a lot of the software written around the device itself. And that's where we understand what their needs are, solutions are, their implementations where there's gaps. And then we help shape that for them and make sure it matches what they need. Yeah, like Michael said, never any one size fits all. It's always very customized. And that's where we shine is helping just lead them through that. They don't need to micromanage it. They're not just hiring a handful of developers and needing to tell them what to do. It's like, we take it kind of from, "You articulated the problem. We'll fully craft and implement a solution for you and then work alongside you for assessing how that works, how much it's solving your problems, what emergent needs are there, what maybe needs iteration." So we also view this as long term engagements typically, and we find that's what works well for our customers as well. Usually you're not just building something and then just abandoning it. Hopefully this goes for years and years as a successful product that you continue to iterate on, improve in the field, and then you necessarily need these other systems to work alongside it. So, I find that a lot of people have a bit of a fear that. We'll build something for you and then kick it over the wall, and then now your team has to manage it. Good luck. And I don't like operating that way. I enjoy continuing to see the success of something I build. I like standing by what we have built. And so that's kind of our outlook on it, I guess, and how we try to assist people a little bit on the side, I guess, maybe, but hopefully that made sense. [00:11:37] Lindsey Dinneen: Yes. No, that's incredible. Thank you so much. So, you know, I know you said that one of the strengths that your company brings is having this flexibility, being able to, like you said, be very customized with your approach to different companies and really help them because no problem is exactly the same. But I am curious, have you come across some themes that are a little bit common, especially in the medtech industry, that perhaps folks who are in the process of developing something could be aware of. What are some of the things that you commonly see that your company could help or they should be thinking through. [00:12:15] Justin Bantuelle: I think that security is a big one that tends to get overlooked until the project is finished. And then you're going through some final regulatory steps and the security team comes in and assesses it and goes, "You didn't think about any of this." And now you're re architecting like half of what you built. I think that's probably the biggest pain point I see. There's like a major gap in looking at that. And it's important everywhere, but a lot of fields aren't as highly regulated, so they get away with not sweating it as much until it bites them. Whereas you can't really do that here. You're not launching if you didn't put these considerations in place. And that's something that I think it's more unique to a handful of sectors where, and medtech is one of them, where you're really hurting yourself if that's not at the forefront of your mind. And so somebody who's not used to those considerations is probably not going to build you the right thing up front. And you're maybe not knowing how to articulate for this part of what's being built as a client that "No, you really need to think about this. We're going to be doing this as part of the process afterwards." Usually it's a completely separate team and it's all part of the documentation, filing it, getting it all in right at the end. And that's a terrible time to find out that you should've thought about something. So that's the biggest one that comes to mind up front. [00:13:37] Michael Roberts: Yeah, I can jump in as well. I think one of the big things that we don't see a lot of medtech companies do that, that we ended up helping, right? If they had this right, they probably wouldn't need our help as much with it. But one of the things is that I think that, because this is such a complicated industry, everybody kind of gets used to sort of a cruddy experience. You know, it's like, "Well, man, this system is really slow, but you know, it's okay. It's just an internal tool." Or, you know, "Just the physicians are using this one so it's not as bad. We can make it too complex, too messy to whatever." And everybody just seems to say like, "Ah, well, that's good enough." And I think that, one of the things I've been surprised by that people aren't considering more, is just how much we are all acclimating to an Amazon experience, to all of these kinds of things where we just expect it to work. And then as more and more of these AI systems catch on and we get used to being able to just talk to the systems and they just do what we want them to do, I think that that frustration is going to get more and more apparent even on systems that have nothing to do with AI, even if they never touch it. We're just getting used to faster and faster systems that intuitively work. And there are so, so many in medtech that don't across the board. And it's not just the stuff that we work with, but I think that there's a lot of pain points in that area. [00:15:00] Justin Bantuelle: That's a really good point as well. Yeah. Yeah. I think most people are familiar at this point with Amazon being able to measure exactly how much money they lose per a 10th of a second longer the page loads, right. And you're right, Michael, that this platform isn't the, like what we're building, these visualizations, these like post procedural dashboards, things like that. Those aren't the product. Those are supplementing it. Those are where you're getting augmented value after the product has done a very good job performing a procedure. And, so yeah, it's much more-- pretty much every system that physicians use in hospitals, like when you're on a computer in there, if you're a physician, if you're working the desk, whatever you're doing in there, those systems are often ancient, very slow, bad interfaces. And so I think Michael's right that a lot of companies sort of overlook that because they sort of assume this is the norm in this space. It's like, "No, we can do a lot better than that." And that's sort of baseline for us. And that's easy for me to forget that a lot of people are trying to cut corners on that front or not prioritizing that aspect of it. And you do see fall off in usage as a result of it. And yeah it's not something to be neglected. [00:16:19] Lindsey Dinneen: Yeah. So just in general user experience and being able to help companies navigate that. And you know, actually, that goes back to what you were saying earlier, Michael, the idea of "wouldn't it be cool if," you know, so "wouldn't it be cool if this worked really well"... [00:16:37] Michael Roberts: Right. [00:16:38] Justin Bantuelle: Right. [00:16:38] Lindsey Dinneen: ...instead of settling for, like you said, a cruddy experience. Maybe there's something else we could do. And I love that sort of "what if" idea, because it just opens you up to all these possibilities. [00:16:50] Michael Roberts: Absolutely. [00:16:50] Justin Bantuelle: There's some things that are sort of corollaries to that, where a lot of groups don't consider. A lot of developers, I find as part of the user experience, so much of that is there's accessibility considerations and how severe a look it is if you're borderline non compliant with ADA, when you're in the medical field, like that's embarrassing, right? And potentially outright illegal. [00:17:16] Lindsey Dinneen: Right. [00:17:17] Justin Bantuelle: And these things often also can get overlooked if you don't have somebody who's used to doing this in the space with the interfaces that they're building. [00:17:25] Lindsey Dinneen: Yeah. That makes a lot of sense. Yeah. So I'm curious as you've worked with all these different companies and you've had very cool experiences, are there any moments that stand out to you as really confirming to you? Yes, I'm in the right place in the right industry at the right time. [00:17:45] Michael Roberts: This is a big question. You know, it's interesting. We've been involved in a variety of different types of projects. And as we've talked about stuff going into COVID, you know, when we were prepping for that there was work that we were doing with physicians directly, the stuff that I was, that I started off doing at the company, we still do work with physicians directly. And then we do work with some of the companies that were involved at various stages of vaccine creation process and all that kind of stuff. And so as we were sitting home during COVID and everything's going down and everything's happening all around the world, it's like, "Well, hey, we're at least helping some of these groups navigate this process." We're at least helping out some of these institutions continue running, or helping them get their messaging out or helping them in one way or another. We actually had a podcast previous to the one that we have now, and it was called The Paradigm Shift of Healthcare. And we named it that before COVID hit. We had no idea that was coming. It was just like, hey, consumers are more of a part of the healthcare process. People are making decisions more on their own and then everything changed about healthcare. And so, definitely made for some interesting conversations about, "Yeah, we had no idea that this is what was coming." But I do think that going through that process, seeing the provider side of it, what they were dealing with, we dealt with a lot of orthopedic surgeons who had to close their practice during the worst of it, right, when everybody had no clue what was happening. So there was that process. It was a lot of getting communication out on their websites, getting information out that way as they were trying to figure out any kind of remote appointments that they might be able to do. Figuring out that for short term, helping them just get some of that information on their sites and everything. And then, yeah, like with working with the companies as they were going through all this mess and trying to figure out how to allocate resources and all that. So that was probably one of the big times I think of like, "Okay, again, we're in the right space, beyond just this is how it's impacting my family, but it's impacting all of our families right now." [00:19:43] Lindsey Dinneen: Yeah. Thank you for sharing. Yeah. How about you, Justin? [00:19:47] Justin Bantuelle: Yeah, I think I touched on this a little bit in the intro, but something that really stands out to me is working on supporting this robot. I didn't work on the robot itself, but obviously we're working on these systems that are ancillary and critical to the overall business operation of it. And it wasn't at market yet when we were coming in and assisting, and so seeing that process where it went through to market and seeing all of the studies that are continually coming out as they're performing this to submit to the FDA, and the actual tangible data showing the massive improvement in patient outcome and realizing that like, "Yeah, we're working on things that really are transformative for care." I had no idea how bad the space was in terms of outcomes before this robot was coming in and how much it was going to make things better for patients. Seeing the actual, tangible impact that it was going to have and that it has have since coming to market was really remarkable and something that it was like really proud to be involved in some capacity. And it just made me that much more excited about continuing to support these groups as they're doing this. [00:20:55] Lindsey Dinneen: Yeah. [00:20:56] Justin Bantuelle: It matters. And seeing the numbers on it really drive it home for me. [00:21:00] Lindsey Dinneen: Yeah. Yeah, absolutely. Both of you have said at various points, things like "it matters," like "matters" has been like a big theme so far. And I think there is so much to that. But I am curious to dial a little bit more into it because, obviously, work in general matters. There's ways that you can make an impact in any field, but what drives you when it's a particularly difficult problem, or frankly, or a difficult client where it's a little bit challenging to maybe see eye to eye. So what continues to motivate and drive you to this work that you know matters so much? [00:21:41] Justin Bantuelle: I think, for me, it's wild to see that some of this is actually life and death. I never worked on something where like, and even some of what I'd done within medical device was just quality of life, which matters a lot too. But then some of this is about like diagnostics where a delayed outcome, a delayed assessment of the diagnostic and a misdiagnosis due to challenges with diagnostics, these things could be the difference if somebody survives or not, or like how quickly it gets them into treatment. So that's a weightiness that I never dealt with before prior to this. And so that was different than any jobs I had before where, I mean, I cared about things in like retail, but it's still, hopefully nobody's dying as a result of anything if they don't get the right thing. So there was a weightiness to that, that I guess carries a commensurate responsibility on the same side, is there anything to talk about what keeps me going with it. For me, I don't find myself necessarily pushing through. I don't find client engagement to be that challenging. I find that everybody does care, but miscommunication can happen, but I try not to center myself in any of that. And I find that giving others the benefit of the doubt as well on that usually leads to a pretty comfortable resolution. I'm there to help solve their problem. I'm not there to win an argument or be right on the direction we take, and I've definitely recommended pathways before from a technical standpoint and they just disagree or overrule and I don't think that's necessarily the best pathway, but I defer to their judgment on what they want in this field. And we're still working towards an end goal. If I ever feel like what we're doing is not helpful, then I don't want to take their money and build something that's they're going to be unhappy with. So, yeah, that, that part of it, I don't really necessarily personally experienced or feel that much, but it does help me just for from a personal motivation standpoint to see the outcomes on this. I don't think you always necessarily get to see that information. Some of our prior retail jobs, I don't know how happy somebody is with something once they go home with it, like unless they're coming in to return it, right? But here, it's not so much about the customer satisfaction the same way. There's very measurable. Improvements to treatment, diagnostic outcome. These things are very measurable, so you can see the results of it. And it's nice to see that you're achieving something with this, that you can [00:24:16] Lindsey Dinneen: Yeah. [00:24:17] Justin Bantuelle: estimate and keep with you as opposed to just hoping that it it's impacting somebody positively. [00:24:22] Lindsey Dinneen: Oh, yeah. Excellent. Do you have anything to add to that, Michael? [00:24:26] Michael Roberts: Yeah, I'll just quickly touch on-- so I actually came from a ministry background, from a faith background. And so part of, I guess my heritage in that field is this idea of service and this idea of trying to better people's lives in some way. And the concept of, when I started working with the physicians directly and still kind of applies with medtech companies same way is like, in my mind, I frame it as helping the people who help people. You know, really helping equip them so that they don't have to worry about that. They can go do their job. They can focus on the serving that they're doing. I don't enjoy being the frontline person. So, when I was working for churches and stuff like that, I did some stuff where, you know, I did a mission trip and we built a house in Mexico and you see that like, "Man, this makes such an impact." But it's exhausting and it's hot and it's really tough to do. And, "Wow, what if I could help equip people that are going to be in those kinds of areas?" I could never work in a hospital. I could never be that person. I don't have that mental fortitude. I don't have that emotional fortitude to do that every day. But if we can help make that process easier, I can deal with a lot of stuff in the meantime to help that part, you know, and let them do their job well. So that's the framework that I kind of bring to it. [00:25:45] Lindsey Dinneen: Oh, I love that. Yeah. Thank you both. Well, pivoting the conversation just for fun, imagine that you were to be offered a million dollars to teach a masterclass on anything you want-- could be in your industry, doesn't have to be. What would you choose to teach and why? [00:26:03] Justin Bantuelle: Yeah, okay. It's kind of similar to what or it's related to what we just talked about those frustrations of the customer. I'd really want probably to teach something along the lines of empathy and listening, like active listening. I feel like so many of the problems that I see in the workspaces and personal exchanges boils down to a form of miscommunication and boils down largely to making bad assumptions about what the other person is thinking or feeling. And I find that you can alleviate a lot of that. And I think it's just being able to really put yourself in their shoes, understand their motivations, understand what their pain points are, what they're trying to achieve. I've seen people butt heads just so many times and often felt it was unnecessary. They're not, neither of them's wrong about anything, but I think they kind of lose sight of the common goal that they share. And I've often helped my own employees who maybe feel like they're getting antagonized and help them reframe like what's going on and why it's not about them. It's not a personal attack kind of thing. I've seen Issues with clients where two different departments are having an issue. And I have less control over helping ameliorate that, but maybe sometimes helping to talk through it and just bring an outside perspective on it. Just with friends, family that struggle, often I find that advice to try to take a step back and reframe what's going on and think about that. I think there's a lot of techniques that, and it makes your life better, right? You're not getting the outcome you want if you're in conflict with somebody else and that's something that I think is one of the most unnecessary friction points often in a work environment or in a personal environment that I really try to put at the forefront of my mind when I see something kind of going wrong or when I'm experiencing something where I feel like I'm not getting my point across or somebody is not really understanding. And there's probably something going on their side where I'm not communicating well myself and taking that step back and understanding what's happening. Just, I feel it makes a big difference in the outcomes for everybody. [00:28:25] Lindsey Dinneen: I, and I really appreciate that perspective. It goes back to something you said earlier too. It's kind of, you know, you're on your client's team. It is you all against the problem. It's not you against each other. And it should never be. So trying to always remember that, or even in a work situation where it's maybe colleague to colleague, again, you're on the same team. So how do we go us against the problem rather than us against each other? So I really appreciate that perspective. [00:28:54] Justin Bantuelle: Yeah, I think, yeah, I find that it's not that frequent that somebody's actually acting in bad faith. It's not that it doesn't happen, but I think it happens a lot less than we may be assumed. I do think that how much of our communications now are via text instead of verbally where you can hear tone a little bit more, I think it becomes a little easier to misread something and that can help contribute to the miscommunication that can then boil over into something. So yeah, it's a challenge probably we all face. I certainly like for all that I care about this and I'm talking about it, it's a challenge I face as well, but I think that awareness kind of helps to check yourself and reevaluate and maybe change how you're communicating that. [00:29:42] Lindsey Dinneen: Yeah. Amen to that. Michael, what would you teach? [00:29:46] Michael Roberts: I should have gone first. That was, that's like sets the bar so high. I think that the thing that I would try to teach is focusing on learning different types of skillsets that you've had before. I think that the next 10 years, we're just going to consistently see that need for everybody to keep reshaping how we interact with our work world with just the world in general. There's just so much that's changing and happening right now. And so I see this some for just basic literacy of the world that we're going to need this. But also, you know, I had to transition from one job to another. I started out in ministry and it was not for me and I needed to do something else. And it was hard. It was a good long while before I found the right fit and skilled up enough in that area for it to work. And so bought myself a book on HTML, code your first site in 30 days kind of thing. And did that and figured out how to put together a very crude website. It was just not great, but it worked. And but that kind of stuff, you know, what's possible today for people to keep on learning, to be able to shift from career path to career path. And then knowing how much you actually do bring with you because you very much feel out of your depth in so many ways. And I felt out of my depth at Health Connected for a good long while. But finding these experiences, these things that I'm bringing to the table, helped shape me and helped me deserve to be here in a way. And I think that everybody has that. It's just unpacking all that stuff, you know, and so getting the skills we need and then being able to figure out how like to actually like match up with where we're trying to go. [00:31:22] Lindsey Dinneen: Absolutely. Well, and you know, that's such a good point too, because sometimes I think it can feel, especially when you do transition jobs or even broader industries and you do feel a little bit out of your element. And I think the thing that you can also remember is, though, it is a strength to draw from all of these different sources of information and experiences that you've had over the years and maybe actually it is a really positive thing for you because you can go, " I don't know if MedTech has ever considered X, Y, and Z, but we did this in hospitality and let's just try it, you know?" And so I love that idea of bringing all the things together and allowing it to help shape you. [00:32:04] Michael Roberts: Yeah. Watching customer experiences be bad in healthcare just kills me. It just, 'cause you'd automatically lose in hospitality. You're automatically out if you don't have your customer experiences solid. That's the benchmark you have to start there. So [00:32:19] Lindsey Dinneen: Excellent. Yeah. Well, how do you wish to be remembered after you leave this world? [00:32:25] Justin Bantuelle: I, I think more than anything, I would just want to be thought of as somebody who was kind. It really matters a lot to me. I care about how people feel. I care about helping people. I'd like people to think that I always did right by them and helped where I could. So, that's at the forefront a lot of what I try to make decisions on in my personal life. So hopefully I live up to that. [00:32:56] Lindsey Dinneen: I love that. [00:32:57] Michael Roberts: I would add something similar to that, I guess, would be willing to invest in the people that I cared about, that I was willing to disrupt my day, ' cause I can get so focused on a thing. When I was a kid, I wanted to be an artist of some sort, and that you think about the artists that have kind of stood through time and it's like, "Oh, well that's the pinnacle of what it means to be a person is you're remembered through time for some major achievement." And it's like, well, yes, there are a handful of people that do that, but I think being able to be remembered that you valued other people as being more valuable, as being more worthy than whatever project you had at the moment, 'cause so many projects come and go. It's something that we all need to do, is something we all need to work on, but yeah, investing in those relationships [00:33:45] Lindsey Dinneen: Absolutely. And I think that's a good reminder. Both of your points are very good reminders, especially for entrepreneurs who, I'm sure that most of them feel that everything kind of weighs on them. And so it is easy to get deep into project mode and maybe forget sometimes that they are human. So being kind and investing and willing to disrupt your day. But yeah that's really powerful. Thank you both. And then final question. What is one thing that makes you smile every time you see or think about it? [00:34:16] Justin Bantuelle: Sure. I think for me it's, I like animals a lot. I have my pets that I'm very fond of. I spent a lot of time looking at animal photos and videos online as I'm sure everybody does. I'm particularly fond of ones where it's two completely different species of animal that seem to be best friends. That is what really helped shape a positive day for me in the morning, if I come across some of those and that is just the cutest thing in the world. [00:34:40] Lindsey Dinneen: Absolutely. How about you, Michael? [00:34:44] Michael Roberts: For me, it's just being out, out somewhere where I'm just surrounded by nature and just getting that moment. And it's not, it doesn't make me smile in the same way, I guess, Justin, but it does kind of bring that peace every time I'm there of, no matter what else is going on, it's like, "Okay." Grounded, in a way and it's like, "Okay I'm here. I'm ready. And I can go face the day." [00:35:04] Lindsey Dinneen: Yeah. Yeah. Excellent. Well, thank you so much, both of you, for sharing your stories, your insights, your experiences, and even some advice. I really appreciate you taking the time today. This has been such a great conversation. And we are so honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational, and safe environment. So thank you so much for choosing that charity to support, and I just wish you both the most continued success as you work to change lives for a better world. [00:35:46] Justin Bantuelle: Thank you so much. [00:35:48] Lindsey Dinneen: All right. And thank you also to our listeners for tuning in. And if you're feeling as inspired as I am at the moment, I'd love it if you'd share this episode with a colleague or two and we'll catch you next time. [00:36:01] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Chad Bareither is the owner and principal consultant of Bareither Group Consulting. Chad shares his journey from working as a civilian engineer in the U.S. Army to becoming a Lean Six Sigma Master Black Belt and consultant for medtech and pharma companies. Chad discusses his process improvement framework, the importance of understanding both systems and people, and insights from his recently published book "Improve LESS." He also covers the transition from being an employee to an entrepreneur and the qualities essential for leadership in the industry.    Guest links: https://www.linkedin.com/in/chadbareither/ | https://www.bareithergroup.com/ | https://www.youtube.com/channel/UCTjC2ZBL3mqnriCeAIkmSlQ Charity supported: Polaris Project Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 045 - Chad Bareither [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome to another episode of The Leading Difference Podcast. I'm your host, Lindsey, and I am so excited to introduce you to my guest today, Chad Bareither. Chad is the owner and principal consultant of Bareither Group Consulting. He partners with med device and pharma company leaders to boost productivity. This is delivered through the Focus and Align Framework, the subject of his book, "Improve LESS.". Chad is a Certified Lean Six Sigma Master Black Belt and holds a Bachelor's degree in Mechanical Engineering from Michigan Technological University, as well as Master's degrees in both Industrial and Systems Engineering and Applied Statistics from Rutgers University. He has over 10 years of experience in the med device and pharma industries and almost 20 years of professional experience. All right. Well, welcome to the show, Chad. I'm so excited to talk to you today. [00:01:42] Chad Bareither: Yeah, thanks for having me on. [00:01:45] Lindsey Dinneen: Of course! I'd love if you wouldn't mind by starting off telling us a little bit about yourself, your background, and maybe what led you to what you're doing now. [00:01:54] Chad Bareither: Sure. So I started my career in the US Army as a civilian engineer. So my background's in engineering, mechanical, I have a degree in mechanical engineering and also industrial engineering. So I started out in the U. S. Army as a civilian doing acquisition projects. So we would design and then purchase componentry for our warfighters from various defense contractors. And so my role in that was quality. So understanding are we designing all of the elements correctly. Then when they're being produced, are they meeting our specifications? And then once they're in stockpile, do they continue to work before we hand them to the brave men and women that are defending our freedom. And so I worked there for a while and pretty early found my niche that I was really into process improvement. So I would visit defense contractors, and if we had an issue, what I was really seem to have a knack for was helping to understand the process and make it better. So we could either expand capacity or have better quality. And so that kind of bridged right into a unique program they were introducing at the time, which was called Lean Six Sigma, which is a corporate program for reducing variation and improving efficiency of processes and the corporation at large. So I was pretty lucky that these two things coincide at the same time is that I was finding my niche and they were rolling out a program that really focused in that. So I was able to get into one of those programs, get trained and certified. And then I followed that path on to several other industries, including med device, pharma, and then was also a corporate employee in some utility, electric, natural gas. After my last corporate engagement, I went off on my own and I began consulting. So delivering the same services I had internally to those larger organizations. But now I have the ability to target smaller or growing organizations. In my consulting engagements, if you combine corporate experience and consulting engagement, it's somewhere around eight industries that I worked in. But I really enjoy the work and the challenges in med device and pharma a lot more. There's the purpose behind it of serving patients, and there's also some really significant technical challenges that I just find are fascinating to learn about. So for the last-- oh, it's six years now-- I've been consulting delivering those services in various industries, but really trying to focus my space into the medtech arena. [00:04:46] Lindsey Dinneen: Nice. Well, first of all, thank you for sharing a little bit about your background. I appreciate it. And it's fascinating to hear how you started off with one focus and then it just continued to evolve and twist and turn into this amazing consulting career that you have now. So many questions, but the first is could seven year old Chad have possibly anticipated what you're doing now, since it's different than what you started off with. [00:05:15] Chad Bareither: Yeah, no, I think seven year old Chad probably wanted to be a professional baseball player. But if I zoom forward a little bit from that, once middle school and high school, I always. naturally gravitated to our math and science was thinking it was going to be engineering. And I did, I studied engineering and most of my day is not engineering. It's really understanding people. But what's fascinating is if I look back, I think what all of my engineering education taught me was really a system for solving problems, right? So the problems that we solved happen to be mechanical design or industrial design. Got it. But taking that mindset of problem solving and now saying, well, the systems that I work with on a daily basis with my customers are a little bit more complex because you have mechanical systems, but you also have people systems that are intertwined with that, right? So, whether I've worked across the spectrum and still do of research and development, clinical trials, manufacturing and post market surveillance and across that. You can have systems set up, but people still operate it. So, it's difficult to just analyze your way into the perfect solution. Even if I can show on paper that it works, like you still need to understand the people elements of it. So I think that's been the biggest evolution through my career is early on, it was like, "I don't understand why we're doing this. It makes sense on paper." And it's like the change management component of that has been really something I've been able to develop personally, I'd say, over the last 6 to 10 years. [00:06:51] Lindsey Dinneen: Yeah. And I'm curious, so bridging that gap between systems and people and understanding that what looks good on paper might not translate as perfectly into real life as one would hope, because we're people and people are complex. So were there certain learning opportunities that you had that helped bridge that gap of gaining your expertise and knowledge in that way? Or what led you to be able to do that so efficiently now? [00:07:23] Chad Bareither: Oof, well, you're assuming I do it efficiently now, so but I'd say I still believe we learn more from failures than we do from success, right? So, there are specific projects or engagements I can look back to. So I'll talk about one specifically. This was a medical device assembly plant. And the particular production line that we were working on, we were trying to increase capacity on, and we even had the team engaged, right? So we were doing everything right in terms of the engagement project, had the teams involved, understood their pain points. We were trying to make it easier for them. And then like on paper again, showed we could do the production line, with the main assembly line, with three operators instead of four. And so we were really pushing for that because being just transparent, looking back now, it's like the productivity gain would have looked really sweet to management. But we had the operators telling us like, "I don't think it's going to work. I don't think it's going to work that way." And we're like, " No, it's going to work," right and pushing for it. And I don't know, you, you get a little focused on your own goals or whatever you, however you want to phrase that. And yeah it was a struggle to launch. And they ended up having to cover some of that with overtime. They made some adjustments long term, but that was a big learning for me of, I mean, if the people actually doing that work eight to 10 hours a day are telling you it's not going to work, like you should probably pull back and either, you've got more explaining to do, more improvements to do, or you should just maybe listen to them a little bit more. But you know, there's other scenarios I can look at that were. You know, when I say failure, right? Not everything means it's a flaming dumpster fire, but sometimes you don't get exactly what you expect out of it. And a lot of it can, I can point back to and say, " Ooh, you know, I could have done a better job. It's not that the analysis was wrong. It's not that the tool we put in place or the management technique or the visualization, it's that we didn't have the right level of buy in or the right people buying in." [00:09:35] Lindsey Dinneen: Okay. Well, I, thank you. I appreciate your honesty and transparency. But I do think to your point, failure or whatever we perceive to be as failure because it didn't work out quite the way we hoped for, is such a powerful learning tool if you can take it and go, "Okay, here's what worked. Here's what didn't. Here's what I can do better next time." And you don't have to go, "Okay, that was a waste." It's never a waste if you can learn from it. [00:10:01] Chad Bareither: A hundred percent. And I think only in recent years, I'd say the last four to five years, that I've really gotten into that of more of a bias for action of, " What's the worst that's gonna happen?" And honestly, I'm not talking about changes that are gonna bankrupt a company, right? It's if you're changing the direction, but " Well, let's try it." So having a bias for action and thinking, just like you pointed out, that it's going to be a learning experience, right? So if you treat it more of an experiment, success isn't necessarily binary-- it was a success or it wasn't-- we learned something. Maybe we got better. Maybe we didn't. But that means the next round, the engagement that we talked about before we started recording, I'm just coming back from-- we had two weeks of not going so well. And then the last week there was finally a breakthrough. And it was like, but I'm comfortable with it. The team was getting disengaged and I'm like, "We're going to get there! You guys stay positive, 'cause I know we're going to get there." And the failures we learned, we know so much more about that process now than we did three weeks ago. [00:10:59] Lindsey Dinneen: Yeah. Yeah. And that brought up an interesting point. So persistence and the willingness or the bias to action, which I really liked the way you put that, the willingness to experiment is something that does take a level of comfort that maybe not everyone is so excited about. But I'm wondering what you have seen over the years as being some of the top qualities of a leader that contribute to that success and that willingness to experiment. [00:11:33] Chad Bareither: Yeah. So, it helps me to think about specific leaders when I, that are like embodying that rather than just speak generically about it. And there was an R&D manager that I work with, his first name was John, but really took the stigma of failure, and I think not even using that word as much, out of it, and just saying, " Let's try and see what happens." And kind of building that learning mindset of, I'd rather move fast and learn something than move slow and get it perfect. And in industries, especially like a bunch of the medtech fields, I know in some of the pharma clients I've worked with, they're looking at things like new technologies, new modality of disease and I'm not a scientist, but these are things that we've never done before. And so the mindset of trying to get it perfect-- like this leader I work with previously, John is like, "Why are we wanting to get it perfect? We won't get it perfect the first time. And if we try to, we're going to be moving too slowly." so that's kind of the first thing that I think of is taking the stigma out of failure and turning it more into trying, learning mindset, things like that. I think the other thing is keeping open communication. And what I mean by that is there's another leader I'm thinking of and his first name was Mickey. And trying to have more open conversations. Information can be used for power, in some cases, or if you're harboring information or knowledge, like, " I'm the conduit, right? So then I become what puts it all together." And he was big on breaking down some of those and having more open conversations about what we're learning and what works and what doesn't work. And I mean, you see teams grow together faster. And so then when you take those two qualities, if I take the stigma of failure off of the organization as a whole, and I work to build more open lines of communication and you build trust, right? So then I'm more, I don't want to say confident-- that's not maybe the right word to go after-- but there's less hesitancy, less fear, maybe. So not being confident doesn't mean I'm not fearful, but if I can take a little bit of that fear, a little bit of the stigma of failure out, I'm willing to try. I'm willing to go off on something new. And as we look at this industry of new advances in technology, new challenges of diseases, we're going to have to keep moving fast and do it in areas that are pretty uncertain. So those are some things that I think help, of saying that we're not going to get it right every time, opening up lines of communication to build trust in the team. And then we can really move faster to a shared goal. [00:14:08] Lindsey Dinneen: Yeah. I really like that. Thank you for that advice and insight. That's really helpful. So now with your own company, consulting, well, a couple of questions, but the first is what stage of business do you usually typically come in on? Or is there not necessarily a stage that's your sweet spot? [00:14:28] Chad Bareither: There's, I wouldn't say right now there's a stage where I could say I have a, a litany of business cases for one stage, so multiple stages. I work with some organizations that are still in-- I mean, so if you think about the business, the corporate stage, established businesses, so they're past what would that be? Series two funding. So commercialized product. So I'm either working with the R&D pipeline on next generation products, next innovation, or in the operation space of improving manufacturing operations are typically the two areas that I'm working in the most. [00:15:09] Lindsey Dinneen: Yeah. Was there an interesting learning curve going from being an employee to being an entrepreneur? [00:15:18] Chad Bareither: Yeah, so let me answer that two ways. The first is moving from being an internal employee to being a consultant, right? Because it's just a different, you're of a different role in the company, right? And then there's also to your point is great moving from being an employee to an entrepreneur. So if you don't mind, I'll kind of tackle both of those. The first is moving from employee to consultant is interesting. Because I was on the employee side when you would have consultants come in. And so leaving the bad taste in my mouth from some consultants we had worked in, they're there to make an impact so that they can either upsell their services or whatever. And I can remember being on engagement. So it's like pushing so hard and just, " I have to work with these people when you leave. So you're kind of creating a mess for us." And just trying to meet people more where they're at. But you know, there's an adage of "a prophet isn't recognized in their hometown." It's sometimes they just need someone from the outside to point out what everyone has showing. And I know that sounds simple, but sometimes you just need to come in and say, "Independent third party here. And yes, that is the problem." So it's nice that you have that sense of authority, but I am personally, I am very cautious about the fact of, look, these people need to live with the solution when I walk away. The worst thing in my mind could be helping a client solve a problem, and then it returned for them. So even if they did want to call me back, that would be seen as not ideal in my mind. I want to help them get to a solution that then they can buy in and sustain. So that, that first change is going from internal employee to consultant where, you do have to make an impact, a splash, a return on investment, whatever you say. But, I'm cautious to also say, but they need to adopt the change. They need to own it. It can't just be my great idea. The other side that you talked about is going from employee to entrepreneur, which is also an interesting transition. As an employee, there's some perceived safety and stability, and I say that just perceived, because depending upon the industry that you're in, as markets change and things like that, layoffs come, things of that nature. So job security is never a hundred percent, but there is some perceived job security and stability there. But as you get past the startup stage, you start to specialize, which means your job responsibility narrows, right? So in a larger organization, typically you become a specialist, but not very broad in thinking, and, and so that can be comfortable as well. You develop some technical expertise. Moving into the entrepreneurial space, which you probably have dabbled in a little bit as an, as a business owner yourself is, you are simultaneously the chief marketing officer and IT support and delivery services, and fill in the blank. So you're wearing a lot of hats. And it can be difficult to gravitate towards the stuff you're really good at. So, I am best at the delivery, the actual client engagements. But I recognize if I'm not doing sales and marketing, and building new connections like that, eventually that work goes away. So it's trying to manage yourself and not stay where you're comfortable, if that makes sense. And not just deep dive all the way down to specialty in one area and have to learn some of these things. Or, you know, find the right people to do it for you. [00:18:49] Lindsey Dinneen: Yeah. Yeah. Yeah. That's very insightful. So you are also a published author and I was wondering if you could share a little bit about your book. [00:18:57] Chad Bareither: Yeah. So the name of the book I wrote in the fall of 2023, it was released, is called "Improve LESS" and intentionally thought provoking title that I got to it in a very roundabout way. The whole concept of the book started behind that, when I launched my consulting firm, I was still working full time as a corporate employee. So a friend of a friend asked if I can help. And I said, "Sure!" And that was a side gig. And then had another one come up and another one come up and then one of those clients wanted something more. And eventually I didn't have time to do a full time corporate job anymore. But then I had three clients that were all kind of different phases and asking for different things. And so I had one client that was really focused on strategy. And, " We need to align our strategy. We need a better way to cascade that in the organization." Another client that was really focused on process improvement. "We want to build our problem solving and process improvement skills for the organization." And I had a third client that really wanted to have better eyes on the business, so we would call it a daily management system, visualization of metrics and understanding the business so we can diagnose problems. Well, once you get good at strategy, then you actually have to go improve the processes. Once I'm pretty good at process improvement, I should probably align those strategically. Once I can see the problems in my business, I need to-- so essentially all of those three clients needed the three parts that were together. So I sat back and I said, "Well, this is starting to become a little bit of a mess. What would I do if I had a new client? What, where would I start?" So I started writing down the process really for my own benefit. And then working with a business coach, I was like, "I'm going to give this away as like a PDF or whatever." They're like, "No, you should turn this into a book." And I'm like, "Like a book?" And they're like, "Yeah." And I had no idea how to do that. So, you know, back to our conversation about entrepreneurs is, so I found someone who did. And I'm work with someone else, a publishing strategist helped me go through everything, which I thought it was pretty good, in terms of editing, that was not the case. So, went through some content editing and professional editing, and then, hired a professional illustrator from my hand drawn drawings. So, yeah, it was a journey, but that's how it started was me saying, " Well, what's my process?" And so really the purpose of the book is it is a framework. Anyone can pick it up and follow it. And I also tried to keep it short. I don't like to be very verbose in the communications to my clients because they need to understand it. So it's literally something that you could read in a weekend and start on Monday. [00:21:39] Lindsey Dinneen: I love that. Okay. So yeah. Yeah. So you've written this book, and you have your consulting firm, and what are you excited about coming up? Maybe both personally and professionally. [00:21:53] Chad Bareither: Yeah. Oh, I think it's easier for me to answer personally. So I'll start there. So my wife and I have three children and they're all pretty active in different competitive endeavors, gymnastics. We talked before, my middle daughter is a dancer, the two girls, the gymnast and the dancer, also play volleyball. And then my youngest son is on a baseball and a soccer team. And so, I mean, I just love supporting them in those. Now I say all that academics are also important. They're doing well academically. That's kind of the condition for doing the sports and stuff like that, but really pouring into them right now. It's It's going to sound so cliche, but our oldest is 13 right now. And some pictures came up, memories on my phone, and it's goes by quick. So personally, I'm just excited about in them right now. And they're turning-- I use this term and my coworker laughs at me-- but they're turning into real people, with their own personalities and their own likes, and it's frustrating at times because they have their own thoughts. Yeah. But it's fascinating right now. And just being able to spend more time investing in them is, is great. Professionally is exciting to really I'm niching back down into this medtech area, right? So I'm carrying a pharma client. I came off a pharma engagement. That was just at the beginning of this year and I've worked in other industries, but I'm just really fired up about the work, the technical challenges in these areas. So getting back into some client engagements that are med device and pharmaceuticals, and then, pharmaceuticals has stuff going on that I don't, I can't begin to understand. Bio therapeutic proteins and cell therapy stuff, which is-- it's fascinating technology, but it's still process, right? And so I might not understand the science, but I do understand process. And I've been able to help in those areas. And it's just, it's humbling to be contributing to the field. So I'm really excited to niche back down in that area and do some more work in this medtech field. [00:23:56] Lindsey Dinneen: Yeah. And when it comes to medtech, are there any moments working with clients that stand out to you as just confirmation that you are in the right place in the right industry at the right time? [00:24:10] Chad Bareither: Yeah. So, I know very little about cell therapy, but basically, you grow stem cells and you make them into other type of cells that would be beneficial. If there's people in cell therapy listening to this, you can correct me if I'm wrong. But I mean, it's just, it's mind boggling the science, but I was working with that group and so they were building up their pilot capabilities. And I'm looking at for more like an industrial engineering, manufacturing point of view, developing standard work. And so they're like, "Oh, this is so helpful." And I'm just thinking, I'm like, "I don't even understand what you guys do. So the fact that I can be of any contribution here is..." But I think, pulling back on that is, you need to invest in your strength. So here's, very skilled multi year experience, PhD scientists. And sometimes they just need someone to help them with structuring up the process flow and the capacities and the standard work that they need to do this consistently. And I'm good at that. And so this kind of harkens back to our conversations about entrepreneurship, right, of knowing what you're good at and knowing what you need help with. And I just, I know what I'm good at. And if I find clients that need help in that area, I'm thrilled to support it. But that was one engagement where it was like, "I understand about zero of what you just explained to me, but I think I can help you." [00:25:36] Lindsey Dinneen: I love that. That's fantastic. One of the things I've noticed and really appreciated about the medtech industry is everybody is really good about celebrating and acknowledging how we all fit into the efforts to make it successful. So even if you are not the scientist, or you are also an engineer, but say in my case, I'm not a scientist, I'm not an engineer, but I do have a marketing ability. And the respect mutually that occurs for everybody's contributions, I think is really special in the medtech industry. I'm wondering if you experienced that too. [00:26:17] Chad Bareither: Yeah. You know, I think there's definitely times it's kind of like a family, right? Families fight, the families get along together. There's definitely times where it's like people are like, "Ah, sales department doesn't know what they're doing," or and you're like, but at the end of the day, you recognize you do need all those parts. Unfortunately, these technologies and this research is expensive. So you do need to sell, right? I mean, that's a reality. So you're right. They do all need to get to, and if people slow down, I think you're right. Eventually everyone's, " Yes, we need all these parts to work." I think there's definitely times where people are having a bad time and they get a little grumpy and they're like, "That department doesn't know what they're doing." But it's, but no, I think all the departments are actually really good at what they're doing. So, you just look at the growth that you're seeing in the industry and the valuation of some of these companies and it's, they know what they're doing and they're serving a need that, that we have supporting our health and wellness. And so it's cool. It's really cool to see that all come together. I think you get a very interesting view of that at some of the smaller organizations 'cause there is a lot more of that trust and that team camaraderie, but even, you know, I worked for a fortune 500 company when I was in in med device, as a corporate employee. And you still have that, within the product teams, within the production teams, that they're there to support each other, they're there for the win. There's also a healthy dose of competition in the industry, I think, that makes it a really driven. So it's, it's fun to be a part of it's fast paced because of the personalities. It's fast paced because of the science. It's fast paced because of the competitiveness with other competitors in the industry. So yeah, it's a fun space to be in. [00:28:00] Lindsey Dinneen: Yeah, absolutely. Yeah, so pivoting the conversation just for fun, imagine that you were to be offered a million dollars to teach a master class on anything you want. It could be in your industry, but it doesn't have to be. What would you choose to teach? [00:28:17] Chad Bareither: Yeah. So this is maybe, I'm hopefully not being risk averse here, because I would teach something that I'm already good at teaching. So some of my favorite things to teach are structured problem solving. So most people that are in any type of leadership position got there because they were probably good at solving problems. And I think where we have challenges in, as organizations grow, is that not everyone solves a problem the same way. So how do you develop the new talent coming up to be like those next leaders? And you can't, you shouldn't just rely on individual people to be like, "We'll just find the good problem solvers and they'll go up." I've seen in organizations where you can really multiply, even exponentially grow, the pace of improvement by having structured problem solving in. So that's what I would do. Personally, that's DMAIC formatted problem solving. It's a five phase problem solving approach: Define, Measure, Analyze, Improve and Control. So that's something that I love teaching because I love the lightbulb moment that goes off in people's heads and we teach them that. There is a portion of that is statistics and I love teaching statistics because most people think this is going to be the worst thing ever and I tried to make it a little bit fun and they're like, "Oh, that was fun. And I learned something." And that's what fires me up. So yeah, it would be structured problem solving. That's what I would teach a masterclass on. [00:29:43] Lindsey Dinneen: Okay, I like it. And how do you wish to be remembered after you leave this world? [00:29:49] Chad Bareither: Oh, my. So my love language that I express as in service. Helpful, that's, I think that's the main thing. Whether it's in a client engagement or in the neighborhood or the family, I enjoy helping people. And so whether that's consulting on the launch of a new diagnostic device or helping someone repair their tractor, right? I enjoy engaging and learning with people and solving problems together. So I really like helping people. So I think I'd like to be remembered in that way. Helpful. [00:30:27] Lindsey Dinneen: Yeah, I like it. Absolutely. And then final question. What is one thing that makes you smile every time you see or think about it? [00:30:38] Chad Bareither: One thing. Well, I don't know. I've smiled a lot this week, seeing pictures of my kids when they were younger, because I don't know, maybe my iPhone's just paying tricks on me. It keeps showing pictures of my kids when they were little. So that's it. I think right now, just the point of life that I'm at right now as kids, two of my brothers just had babies as well. So little kids and just me realizing like my kids are never going to be that age again. I've been on travel and seen a lot of little kids in different cities, and it's sweet because it's so simple. Their world is so simple at that age. So I think it makes me smile just because the innocence is there. Yeah. I'm gonna stick with that. [00:31:17] Lindsey Dinneen: Yeah, great answer. It's, it's special to witness and it always brings a smile too. Especially little kids at airports that are dragging their tiny little backpacks or rollie bags behind them and they've got their best stuffed friend. Oh my gosh, it's so cute. [00:31:35] Chad Bareither: So one thing that's been interesting to see is when people have younger kids, and maybe they're misbehaving or maybe they're just excited, right? And the parents are kind of flustered. It's just it's, it brings a smile to my face. Not because the parents are flustered. It's just because I can remember being a parent and you make a big deal out of it, and it's man, but I just appreciate the innocence and the genuine joy that this small human is trying to have right now. And it's, I think, that's the thing right now in my life. That's bringing a smile every time I see it or think about it. [00:32:05] Lindsey Dinneen: I love it. I love it. Well, Chad, this has been an incredible conversation. I really appreciate your insights and advice and everything that you're doing. If anyone's listening and needs some outside support, please definitely get in touch with Chad. We are so honored to be making a donation on your behalf as a thank you for your time today to the Polaris Project, which is a non governmental organization that works to combat and prevent sex and labor trafficking in North America. So thank you for choosing that organization to support. And we just wish you the most continued success as you work to change lives for a better world. [00:32:42] Chad Bareither: Thanks a lot. And you got a lot going on. So I wish you continued success in all your endeavors as well. [00:32:49] Lindsey Dinneen: Awesome. Well, thank you so much. And thank you also to our listeners for tuning in. And if you're feeling as inspired as I am right now, I would love it if you would share this episode with a colleague or two, and we will catch you next time. [00:33:04] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Dr. Silvia Blemker is a distinguished professor of biomedical engineering at the University of Virginia and co-founder and Chief Scientific Officer of Springbok Analytics. Silvia discusses her fascinating journey from a curious child who loved learning about anatomy to now leading groundbreaking research at the Multi-scale Muscle Mechanophysiology Lab. Learn how her innovative AI-driven muscle analytics technology is reshaping fields ranging from sports medicine to neuromuscular diseases. Silvia shares her passion for mentorship, the rewards of pushing scientific boundaries, and the thrill of solving complex challenges.    Guest links: https://www.springbokanalytics.com | http://www.uvam3lab.com Charity supported: Sleep in Heavenly Peace Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 044 - Dr. Silvia Blemker [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I am very excited to introduce as my guest, Sylvia Blemker. Sylvia is the Robert Thompson Distinguished Professor of biomedical engineering at the University of Virginia. She leads the Multi-scale Muscle Mechanophysiology Lab, which develops multi-skill computational and experimental techniques to study skeletal muscle biomechanics and physiology. The lab explores a range of applications including speech disorders, vision impairments, aging, muscular dystrophies, and human performance. New projects include developing models that incorporate for sex differences in musculoskeletal structure and simulating the effects of estrogen levels on muscle regeneration. Dr. Blemker is also Co-Founder and Chief Scientific Officer of Springbok Analytics, a company commercializing image based muscle analytics AI technology for many applications from muscle diseases to sports medicine. All right. Well, welcome. And thank you so much for being here. I'm so delighted to talk to you today, Sylvia. [00:01:55] Dr. Silvia Blemker: Thank you. I'm excited to be here also. [00:01:58] Lindsey Dinneen: Awesome. Well, would you mind starting off by telling us a little bit about yourself, your background, and maybe what led you to medtech? [00:02:08] Dr. Silvia Blemker: Sure. So I am born and raised in Lawrence, Kansas, a child of two immigrants who are from Argentina. And they're both professors. So from a very early age, I was exposed to the world of academia. My dad was a mathematician. My mom was a math person also. So, math and STEM was always from the get go part of my life and I knew it would be in the future. And when I was trying to decide what to study as an undergraduate student, I learned of this field called biomedical engineering that was somewhat of a new discipline at that point. I started college in 1993. And I just thought it sounded perfect because I was really interested in medicine. I loved anatomy. I was one of those geeks that had anatomy parts, like models. I had an ear and I had an eyeball and a heart, all these different things. I just thought anatomy was really interesting and cool. And I always thought being a doctor of some kind would be really cool because it would mix my interest in biology and anatomy with wanting to help people, but I don't think that was the right path for me, and it also wouldn't really leverage my interest in math and physics and stuff like that. So once I learned about biomedical engineering, I thought, "Wow, that sounds really perfect for me." And so it turned out it was because I did my undergrad in biomedical engineering from Northwestern University. I did my master's degree there, and then I went on to Stanford University. I got my PhD in mechanical engineering. But honestly, I would have been bioengineering, but back then there was no bioengineering department. So I was in mechanical engineering, but focused on biomechanical engineering. And now I'm a professor of biomedical engineering at the University of Virginia. Been that since 2006. And I also, it's been about 10 years now, co founded a company that's in the medtech industry. It's called Springbok Analytics, and it's commercializing software to go from a rapid MRI scan to a fast assessment of muscle health and fitness. [00:04:22] Lindsey Dinneen: Amazing. Well, thank you for providing some background and whatnot. That was so fun to hear about, you know, your interest in biology from even a young age and having all these models and that's just, that makes me smile. I love that. [00:04:35] Dr. Silvia Blemker: like collecting bugs, too. That's weird. [00:04:39] Lindsey Dinneen: Hey, you were interested in it. I love that. So I have so many questions, but the first thing that comes to mind: I love the name of your company and I'm curious why you chose Springbok. [00:04:50] Dr. Silvia Blemker: Yeah, that is a great question. So, it was inspired by the springbok, the animal. It's very fast moving antelope that runs fast. It's very agile, jumps high. And the reason why we went that direction is our first market at Springbok was in human performance and elite athletes. And so we were using this technology to help athletes recover from injury and get to their maximum performance. So that's where that went. And, you know, honestly, when we first started it, we just kind of like dreamt that up and didn't know if it would stick, but now it has. And so here we are. [00:05:32] Lindsey Dinneen: Excellent. So, yeah. So, okay. With the origin of that company, you brought something to market that has previously not existed in the way that you're doing very uniquely. Could you share a little bit more about what makes what you do so unique and how it's helped solve or covered a gap in the market, basically? [00:05:54] Dr. Silvia Blemker: Sure. So I guess maybe while I answer that question, I'll tell you a little bit about where it came from in terms of the initial ideas. So I think that really answers your question too. So, so we're actually, it started as a research project in a combination of my lab and a few other collaborators at UVA. So started pure research funded by an organization that pro wanted to promote translational research. So research that starts on the very academic basic setting, but is translated to the outside world. You know, we do a lot of research that's very impactful, but it stays in the lab. And the idea is that some of it is ready to go out there. So, having said that, the basic idea for the company actually really came out of some conversations I had with a collaborator, an orthopedic surgeon, who treats children that have cerebral palsy, in particular helps in terms of improving specific movement disorders that kids with cerebral palsy have. And so I've had a longstanding interest in understanding what's happening with muscles in these children because though it's an injury to the brain kind of right around birth which leads to these abnormal movement patterns, that ends up influencing their muscles and bones because muscles and bones grow based on the way you use them. And so this happening as a child means their muscles have a fair number of issues. And so I've been interested in that question, obviously, is if we know that, then we can help better improve mobility and treatments for these children. And so, in my research, I've been making use of MRI a lot to study muscle, because that's a great way to do that in humans. If you're studying a mouse, which we do somewhat in my lab also, you can do a lot with a mouse muscle. But if you want to study human muscles, there's only so much you can do unless you're studying a cadaver, which obviously is not relevant. So, we use MRI and develop these fancy imaging techniques or interesting ways to get a bunch of information about the muscle from the MRI machine, MRI pictures, and do lots of different modeling and things like that. So I was pretty young professor and I was developing new research ideas and this clinician said, his name is Dr. Abel said, "You know, all these interesting ideas about what you can learn about muscle from MRI is cool, but you know this is not something we could ever use in the clinic because the way that you're doing these scans is very hard. It's very research oriented. You're only studying one muscle, and really in cerebral palsy and impacts all the muscles of the in the body, but in particular for movement of the leg. And we don't have a way to, to quantify that or understand that. And that's what I really need to have in order to figure out how to treat these kids." 'Cuz ultimately he's has to do surgeries on a bunch of muscles and he has to make the decisions about which muscles to do surgeries on just by looking at the outside of the child and not really having a sense for what's going on at the muscle level. So I was like, "Okay, well, maybe we'll try to solve that problem." Cause it seems like the problem I wanted to solve maybe isn't all that useful to you right now. So, that, that really was the basis for Springbok the initial idea was to develop a way to collect MRI rapidly and then transform that into a assessment of all the muscles of the lower extremity in particular for these kids because there's really no other way to get information at the muscle level. We have ways to kind of assess how strong people are. But that's what we say in biomechanics, we call it at the joint level, you know, but like, for example, if you wanted to see how strong your knee is, you extend your knee for example, to get your quadriceps, but there's four quadriceps muscles. So if there's a weakness, which muscle is the one that is, you would have no idea what that was if from the outside. Same thing for all other joints. So, that's the idea is like to get to that detailed information and in this particular application it's very obvious why you need that because they're going to go in and do surgery on individual muscles. So they want to do the ones that actually need it. And then, you know, the premise of where we went from there is that, the need to have information at the muscle level has a lot of different applications outside of that. And so that's sort of one thing led to another. And again, because we were funded by this grant agency called The Culture Foundation that wanted to promote translational research, one of the early pieces of feedback they gave us was the market that we was associated with the application we were first exploring in cerebral palsy was too small to start with. And there's too many barriers of entry in terms of being able to actually implement in practice. So that's what led us to shift to other areas in particular. And in particular, elite sports because some of those barriers don't exist. The financial aspects are not nearly as challenging to start. And so it's actually a path I've heard of a lot of other healthtech or medtech companies to go start in sports and then veer into once they've gotten a bunch of data and validation, veer into the medical tech, and then that's precisely our path as well. [00:11:12] Lindsey Dinneen: Yeah. Excellent. Well, well, thank you for sharing more about that. That was such a great explanation specifically about the quadriceps. I really latched onto that because what an interesting problem, but then what a great solution that you all have developed. And, you know, I'm wondering, looking back before you started the company and really dove in, could you have anticipated that you were going to become this entrepreneur? And did you expect that this might be part of your path or was this kind of just a happy coincidence after the research developed? [00:11:49] Dr. Silvia Blemker: Definitely did not expect it to be part of my path. [00:11:52] Lindsey Dinneen: Okay. [00:11:53] Dr. Silvia Blemker: Absolutely. By no means, my brother was the one that went, like he was an engineer too, and he worked for IBM and he became more of a business man. That's what I would call him. But, yeah, it was really, you know, a multitude of things, the encouragement. I had some really good, you know, co founders. Craig Meyer and Joe Hart were both colleagues and they were excited. It was sort of like at that point, it was like, "Well, I don't want to be the limiting factor here. We should all do this together, right?" Found some really fantastic people to help it get started because, of course, when you first start something, there is a lot of risk there. And also, the three of us co founders had day jobs. We're still professors. And so we found a great actually grad of our program. To be our first CTO or first official employee. You really need to have that team around you. It's not just one person or two people, there's a lot that goes into this type of effort. And so I think without that, for sure, wouldn't have done it. And then one thing led to the other, I guess. It's definitely has pushed-- I can speak for myself-- out of my comfort zone a lot, you know, and it still does. But I think that's why I keep doing it also is I've learned a lot. [00:13:10] Lindsey Dinneen: I love that. Yeah. Well, and I think that it brings different challenges than you're probably experiencing in the academic side of things, and that's its own challenge too. But I love the fact that, speaking with leaders such as yourself, you're always pushing yourself to the next thing. You're not really just happy being. [00:13:29] Dr. Silvia Blemker: My husband might appreciate it more, but [00:13:31] Lindsey Dinneen: Okay. Yes, this is fair. Yeah. Well, okay. So, so just briefly switching sides to the academic journey that you've taken. So can you speak a little bit more about the program that you are in and helping to continue to develop? And what are you excited about even just with the university as you continue to grow? [00:13:56] Dr. Silvia Blemker: So I am a professor at heart. Right now I'm in a particularly interesting kind of stage of my career where I'm still a professor at UVA, but I'm actually part time professor and I'm also officially employed by Springbok. I'm a co founder, but I'm right now working as Chief Science Officer. So I do have two jobs. [00:14:15] Lindsey Dinneen: Yeah. Nice. [00:14:17] Dr. Silvia Blemker: Yeah. [00:14:18] Lindsey Dinneen: Oh. [00:14:20] Dr. Silvia Blemker: Sons to o, but it's all good. It's, you know, it's nice full life, but so anyways, I have a research lab called, we call ourselves the Multiscale Muscle Mechanophysiology Lab. It's a mouthful. So we just call her, we say M3 Lab or M cubed. And we have PhD students, be it biomedical engineering, PhD students who are doing research and with in my lab going towards their PhD. I have postdoc, so students that have finished their PhD and continuing training for research in my lab, and then a whole bunch of undergraduate students who are getting involved in research for the first time. And the mentorship there that I do is ultimately, I think, honestly, what I love the most. And I joke with them because I now encourage all of my students to do internships while they're in their graduate program. I think it's incredibly valuable for a lot of different reasons that I could chat through. But I tell them, "You know, I never did that. And I did my internship in my late 40s. Fortunately, I realized that I made the right career choice, but I did it a little late. You should do it earlier." [00:15:25] Lindsey Dinneen: Right. Oh, nice. [00:15:28] Dr. Silvia Blemker: So anyways, I love my students all the way from ultimately in the lab, like exploring, you know, I talk a lot about with them, "You know, what we're doing is exploring the boundaries of knowledge together, pushing it and understanding where the boundaries are and figuring out how to push them in ways that can advance the world, really." And doing that with the student together and essentially I find myself like right behind them. I'm like, "Okay, keep going, teach me while you do it." I just find that, I just love doing that. It's very rewarding. And it's a real impact to be able to train other people to do this work. And there's the relationship aspect of it that is very valuable to me. So I just love teaching and hopefully inspiring new students to get involved in the kind of work I do, or help them figure out what they want to do. I think in the industry in the startup setting that mentorship is also a big part of it, but you know, it's just it's different. So one of the big projects we have that is actually the cool thing is, it's empowered by the startup company. So there is a synergy there which I think is really cool. So we are in the lab creating the next generation versions of computer models of the body that account for differences between men and women, between males and females. So in the world of movement biomechanics, in addition to using MRI as a common tool, another way that we study human movement and to try to figure out what's happening on the inside of bodies is to use computer modeling where we have models that sort of help try to describe the person in as much detail as possible from the inside, their bones, joints, muscles, everything, how their muscles move, and combine that with measurements of motion from the outside and physics and use all that to figure out how the person, how their muscles are working. There's a lots of different questions that you can answer once you have a model like that. The problem is that the model that everybody uses is based on data from like a 5'10 man. And then we scale it to fit anybody. So it doesn't even actually probably represent the 5'10 man, honestly. It's kind of an average. We're doing a big study where we collect MRI data of a large number of males and females, and we're doing a whole bunch of other measurements to allow the field to put that model aside and do a much better job at representing the population in particular, and accounting for the differences between male and female, because a lot of clinical problems, conditions, questions, issues that are the answer to them are different between male and females. And as a field, we don't really have ways to handle that. And I think that we need to do better than that. So it's an interesting project because It's a very, it's, there's a lot of interesting technical thing problems that we're solving to do that, to do these modelings, models at scale and stuff like that. But it's also a bit of like a public service model or a project where we're answering these questions, but ultimately going to give these models to the community so that they can do their research better too. [00:18:37] Lindsey Dinneen: Wow. It, you know, it continues to boggle my brain when I hear things like this, where it's like, "Yeah, we forgot to consider half the population." And I, you know, shouldn't make me laugh very much, I'm just very thankful, is really what I'm going to get to, of people like you who are going, "Wait a second, maybe this one thing that we've used all this time could be done more effectively and represent, like you said, just a better understanding of humans." So I... [00:19:07] Dr. Silvia Blemker: Yeah. It's interesting. You know, I've wondered about this myself a lot, how do we come to be? And I think it's this interesting difference between thinking about the impact of what your science is versus how to do the science well, because as scientists were trained, take out all other extra variables so that you can answer the question, you can control for everything that's your questions not to do with so that you can answer your question or test your hypothesis. And so, if you add sex as a variable, that confounds your question. And then, if anything, it just means that you have to double your sample size, you have to account for that. And so to do it well, but maybe with less resources, it would make sense scientifically to go to one sex. So that's why that happens, right? But then, if you're thinking about, "Well, yeah, but then I only answered that question for one sex," then you would do it differently. So I think that's where it comes from. Honestly, I don't think my predecessors were necessarily sexist or anything. I think they were doing things in the way that made sense scientifically by keeping things constant and wanting to have clean results. So that is what it is, but I think in a world where we're thinking more about the impact of what we do, we can't do that anymore. [00:20:30] Lindsey Dinneen: Yeah, well, and I thank you for sharing that. I think that's a really great perspective and realizing that sometimes It's easy to get annoyed by something that when we don't understand maybe where it came from or why somebody chose the route they did and maybe there was a very just practical reason for it. And so I love that you shared that. Thank you for doing that. [00:20:53] Dr. Silvia Blemker: But I will say that I have gotten annoyed though when you ask the question, like, "Why did you just do men?" Sometimes the answer is just, "Well, that's just how it's done." Not reasonable. I don't think that's, I don't think that's an... [00:21:07] Lindsey Dinneen: A lazy answer. [00:21:08] Dr. Silvia Blemker: Absolutely. Yeah. [00:21:10] Lindsey Dinneen: Yeah, that's fair. That's fair. So, you know, either in your academic journey or perhaps in your entrepreneurial journey, are there any moments that stand out that really kind of affirm to you, "I am in the right industry, doing the right thing with my life?" [00:21:29] Dr. Silvia Blemker: Oh, huh. That's an interesting question. I'll tell you when I know that I'm doing the right thing, when I'm excited to get up and do it [00:21:39] Lindsey Dinneen: Yeah. [00:21:40] Dr. Silvia Blemker: Morning, I'm like, "Oh yeah, I'm going to work all this. This is exciting. I want to figure this out." That's usually what gets me up. Like my husband knows when I'm, we call it "locked in" because, you know, we have Gen Z kids, when I'm really trying to figure something out. And that, that really like gets me like figure something out that I know is important and impactful. I just love doing that. I think ultimately that's what I like and being creative and coming up with solutions and questions and stuff like that. That's not, I don't know if that's answering your question though. [00:22:13] Lindsey Dinneen: It actually, well, it does though, because I mean, everyone answers that in different ways, but what I love is the fact that it's your daily life. That's a great answer to that question. It's, " I'm curious. I'm excited. I want to work with these students and solve these problems." And that's a dream. [00:22:32] Dr. Silvia Blemker: That's what I, that's what gets me up in the morning. I mean, obviously not every day can be filled with these super intriguing things. There's a lot about a daily routine of any job that involves other things. And I try to learn to do those. Like one example of that for me was when I first started as a graduate student. As a scientist, a researcher, you have to present your results or give presentations a fair amount, whether it be to your lab group or to your thesis committee or in at a conference or a seminar. And then ultimately as a teacher, you have to do that all the time too. And early on, I really did not like doing that. It was really painful for me. I was really anxious about it. I loved sitting there working stuff out on my computer. That I loved, I knew, but I did not think I could do any-- presenting was scary. The first time I had to go presented a conference, I literally memorized every single word of the presentation to the word, and even my friends, my graduate student friends who I shared a hotel room with, they could give my presentation. They literally could, but now I absolutely love presenting. It's something that I've come to really enjoy all aspects of it. So that's an example of maybe not everything initially seems like that's what I'm going to love doing, but sometimes you can surprise yourself. [00:23:57] Lindsey Dinneen: Yeah. Well, and I actually, to expand on that, I think the idea of you never know what your next sort of joyful surprise is going to be. So try the things and we'll discover that not everything is for you, but that's such great advice also for students, I feel like in particular, or maybe those young in their career is, "Just experiment, try it." You know, use it as this exciting time to just see. And yeah, you might even hate it the first couple of times, but you never know. [00:24:27] Dr. Silvia Blemker: Yeah. Yeah. You never know. You never know. Absolutely. [00:24:30] Lindsey Dinneen: Yeah. Well, this is going to be an interesting one because I'm going to pivot the conversation and ask you something that I ask all my guests, but in your case, you are used to teaching and giving classes. So the question is, if you were to be offered a million dollars to teach a master class on anything you want, what would you choose to teach and why? [00:24:52] Dr. Silvia Blemker: Oh, a million dollars. Oh, but I, like, I love teaching, [00:25:03] Lindsey Dinneen: Yeah, I know. That's why I was like, oh man, this is gonna be interesting. [00:25:07] Dr. Silvia Blemker: I think it was last year I was so proud of the undergraduate students. They give these awards to professors and I got the Lecturer of the Year award. So that was fun. And then I brought it home and my teenage son was like, "Oh yeah, yeah, that tracks. Mom's the lecturer of the year." [00:25:26] Lindsey Dinneen: Oh! [00:25:27] Dr. Silvia Blemker: Momly lectures. So anyways, it's hard to turn it off, but let's see, what would I give it about? I mean, it would probably be something about how muscles work 'cause I love talking about muscles. Honestly, like at the end of the day, that's now I'm kind of all in it. So I, I like talking about that stuff. Randomly about tennis too. I love tennis. I play tennis as a very low level tennis player, but I've become a tennis nerd. So if I had another job, I would love to be like a tennis announcer, but the science tennis announcer to talk about the physics and stuff like that, biomechanics. I would love that. [00:26:05] Lindsey Dinneen: Oh, I would love that. That would make it so much even more interesting to me because I'd go, "Oh my word, I had no idea that this was what's happening here." And yeah, that's cool. Excellent. Okay. Well, I like it. Well, how do you wish to be remembered after you leave this world? [00:26:23] Dr. Silvia Blemker: Ultimately for my children, like Mom to Jack and Daniel Blemker, number one, then wife to Wes and the rest of my family. I think, ultimately, that's the most important, right? And then as a mentor to my students. [00:26:41] Lindsey Dinneen: Yeah. [00:26:42] Dr. Silvia Blemker: And then for like, you know, doing things that help people. Products that we've put out there, I feel like we've had an impact and we continue to see the potential impact. But honestly, that isn't really about me. It's about the impact. So I don't know that I-- I guess it's good to get credit for stuff like that, but ultimately it's just cool to know that it's had an impact and it's really connected to a lot of people not just me, so I think it's cool like sometimes I do reflect on, when I see cool stuff that the company's doing like "Wow, that was my idea. That's cool." But it's like not just that, right? An idea is just an idea. There's so much more. And the people that we have at Springbok doing, it's just a fantastic team of just ridiculously smart people who are also great, work well as a team and really value having a positive environment and they're fun. They're funny. So that's all cool. [00:27:39] Lindsey Dinneen: That's awesome. That is so cool. Yeah. Yeah. I love that. And then final question. What is one thing that makes you smile every time you see or think about it? [00:27:50] Dr. Silvia Blemker: I have a few different things, maybe. Well, the first one that comes to mind, honestly, is every time, and this is one of my favorite things about doing Springbok, is every time we get like an interesting new scan in, and we look at a large range of individuals now from people with muscle disease, neuromuscular disease, and all the way to NBA players and everywhere in between. But whenever I see one that's different, I'm like, "Ooh, that's cool. That makes me smile." So I guess that's muscles. And then also, I guess the other one is just seeing like a mentee or student shine in some way. One of my former student just defended her PhD two weeks ago, and just sitting there watching her do her PhD defense, she's phenomenal. It was just amazing. I mean, who wouldn't smile at that? But [00:28:43] Lindsey Dinneen: Yeah. Oh, that's amazing, and I love how it all ties together, just your answers are consistent, but I, what I love about hearing that is this just thread of appreciation for muscles and anatomy and impact and the students and the lives that you're touching. So I, you know, I definitely, I love that you're doing what you love and that it brings you joy. That's the best. Yeah. [00:29:11] Dr. Silvia Blemker: That's so nice. That makes me smile. [00:29:15] Lindsey Dinneen: Oh, I love that. Well, thank you so much for your time today. This has been such a joy for me actually, to get to talk to you and learn more about your background and what gives you energy, what gets you up in the morning. And so I just really appreciate you sharing about all the great work that you're doing. And I just wish you the most continued success as you work to change lives for a better world. [00:29:38] Dr. Silvia Blemker: Well, thank you. Thank you very much. Thanks for producing such a cool podcast. So very much appreciated. [00:29:45] Lindsey Dinneen: much. Thank you. Well, thanks for bringing a smile to my face. And thank you also to everyone who is tuning in today. And if you're as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two and we'll catch you next time. [00:30:01] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Nile Harris, a seasoned leader with two decades of experience in the MedTech industry, is the founder and CEO of HVG Executive Solutions and currently serves as a director in the life sciences practice at Alvarez & Marsal. Nile shares her diverse career journey from financial services to MedTech, including roles at Medtronic and Abbott, and her current work in management consulting. Emphasizing the value of lifelong learning, Nile discusses her philosophy on leadership, blending strategy with tactical execution, and the importance of adapting rapidly. She also reflects on pivotal moments, like nearly quitting due to the emotional challenges in medtech sales, and her passion for closing healthcare disparity gaps.  Guest links: https://gapdemystified.com | https://hvg.llc Charity supported: Opportunity International Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 043 - Nile Harris [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and I'm so excited to introduce you to my guest today, Nile Harris. Nile is a highly skilled and versatile leader who has made significant impact in the medtech industry for two decades from the C suite to the operating room and companies such as Medtronic and Abbott. Her agility was forged through a successful cross functional career, spanning corporate strategy and development, product marketing, field sales and marketing, strategic market insights, commercialization, market access, and executive coaching. Nile is an expert advisor and mentor for Life Science Tennessee and the Nashville Entrepreneur Center focused on early stage startups. She is the CEO and Founder of HVG Executive Solutions and currently serves as Director in the life sciences practice at Alvarez and Marsal. All right. Well, thank you so much for being here, Nile. I'm so excited to speak with you today. [00:01:48] Nile Harris: Thank you. I'm happy and excited to be here as well. [00:01:53] Lindsey Dinneen: Awesome. Well, I was wondering if you wouldn't mind starting off by telling us a little bit about yourself and your background and what led you to MedTech. [00:02:03] Nile Harris: Yeah. Interesting story. Happy to share my journey to MedTech. I tripped into it and loved it. I began my career out of undergrad in financial services, actually interned all through undergrad and financial services. And I loved being on a trading floor-- I was actually a licensed broker at one point-- loved working on trading floors. I'm originally from Chicago, worked at the Board of Trade, Chicago Board of Options Exchange, but it wasn't a cultural fit. And I felt like I wanted to give more or put more out into the world other than making more money, essentially. And I went to business school at the University of Michigan and did my internship at Lily in Indianapolis and absolutely loved healthcare. And it had never occurred to me that healthcare was an option. And I spent my summer there as IT Project Manager supporting clinical trials. And I was like, I thought this was just amazing. And so I was recruited to Medtronic coming out of Michigan and they had an IT rotation, leadership rotation program. They're sort of a internal consulting group. And I was in that program for two years. And when I came out of that program, I went to the strategy and corporate development group within Medtronic. And that's when I really saw what we did as a company there. I really have more exposure to the products, the lives that we were saving, and the impact that we were having. And I had really no idea what it took to get a product from bench to bedside. Like, what does it take to get a product designed and into a patient? And I decided to go from corporate strategy and development to field sales and marketing. So I was like, I thought that there was no better way to learn it than just to roll up my sleeves and get into it. And so I went from making PowerPoints and Excel spreadsheets to being out in the field. So I went from being in Minneapolis to Nashville, where I was doing Therapy Development Specialist. So it was a hybrid between sales and marketing. And I spent a lot of time in hospitals. And the part of my job was essentially to grow the pie for thoracic and abdominal aortic aneurysm stent grafts, and then grow our piece of the pie. So I was in surgeries, but I was also doing strategy and sort of marketing and attracting customers and refer referral patterns. And it was great. This was like, this was magical to me. And I had no idea before I got into Medtronic that this was a world that was even open to me. And so I just got deeper into it. I did product management, did value based healthcare and pricing. I did a stop for a couple of years in K 12 education. I'm very passionate about closing the health, wealth, and education disparity gap in America. And so I was a Broad Resident for the system management of school systems. And so I led strategy for a charter school system in Nashville, but went back into working with, with life science companies at a small consulting firm, and then was doing some independent consulting, started doing executive coaching, specifically within medtech for those people who are trying to get to that next level of leadership and trying to figure out how do you run multi generational teams? And then I was at Abbott for a little bit as a Global Director there and built a team there. And now I do management consultant. And so I've been in medtech now for 20 years. And what I love about being a consultant is that I get to take all of those experiences and how companies bring innovations to life. [00:06:20] Lindsey Dinneen: Wow. Yeah. Well, first of all, thank you for sharing about your background. What an amazing breadth of experience you have. And also I love the thread of your lifelong learning and curiosity. And, oh my gosh. I mean, so I looked at your, LinkedIn profile and I was like, okay, so you have a BA, a BS, an MEd, and an MBA. So clearly education. [00:06:50] Nile Harris: I do I believe education is important and so the BS in finance and the BA in communications happened because at the University of Illinois, you can get a BA in Finance or a BS in Finance. And so I went the BS route, but it was very technical. We had these highly technical economic classes, statistical modeling, all these things. There weren't a lot of soft skill classes, and I wanted to incorporate that into my experience. And then I realized, well, if I earned a certain number of hours, I could be a dual degree versus dual major. And my junior year, I had no idea, but my junior year, I got this letter from the university saying that all of my advanced placement classes from high school transferred and I had a semester's worth of additional hours. So I spent an additional summer after I finished one degree and then I was able to finish the second degree. So I did both in four years. [00:07:52] Lindsey Dinneen: Wow. Holy cannoli. Okay. [00:07:54] Nile Harris: I'm a lifelong learner. I believe you need to always be learning. And the curiosity is, I think a lot of times I've gotten the feedback of, "Well, you're kind of all over the place." But not really. I am curious about what people do and how they do their jobs. And I would, when I was in strategy and development, my role was to lead the strategic planning process, and I had access to all of the business leaders, all of the presidents, all of the leaders that they worked with. And that was just awesome. That in itself was just a college education. I had ready access to ask them about their businesses. But I also asked him, "Well, how can I be a better partner for you? If I'm in corporate, how can I be a better partner for you?" And one of the things that came up over and over again was, "Understand my business better. I understand that you have to run the process and you're focused on getting all of the parts and pieces together. But what would help me is if more people in corporate understood my business." And I was like, "Okay, I'm going to go into sales." [00:09:04] Lindsey Dinneen: Yes. Wow, that is so incredible. And, leadership and management, and now with your executive coaching, obviously that's a been a running theme and will continue to be. And I'm really curious what is maybe your top couple pieces of advice for those who are looking to either become better leaders or to even start being a leader? [00:09:32] Nile Harris: That is a great question. I think, first of all, I counsel people to develop your personal leadership philosophy. What type of leader do you want to be? What is the legacy that you want to leave with people? What is it that you want them to remember you for? For me, it was being a servant leader. I see myself as, "People don't work for me. I work for them." My job is to remove obstacles, build them up, set a vision, set the container in which they work and then support them in that. Set the example, model the example and and I always say, you know, the book "Leaders Eat Last." Well, I say, "Leaders eat last and they're the first to the fire." And so you develop that philosophy and talk to people. Like I said, I had access to some amazing leaders and I watched them and I talked to them and I asked them and so, interview people, talk to people who you think are great leaders. The second thing I would say is learn from people who you think are not great leaders. Let them teach you about what you don't want to be as a leader. Right? And the third thing is talk to people. I had one mentor who used to say his version of a quote from Abraham Lincoln, which was, "You can't lead without the consent of the followers. Find out what the followers need and give them that." And leadership is for the people who are following you. Promotions or accolades or rewards are for you as an effective leader, right, for getting results. The leadership is what you are providing to others. [00:11:19] Lindsey Dinneen: Yeah, that's great advice. Thank you for sharing that. I think especially your middle point about learning from leaders that you don't look up to, but that have actually a lot to teach you is such a good point too, because, in general, we look up to the people that we go, "Oh my goodness, I love the way that this person leads. I really admire what they bring to the table." And then, that's great, but it is also such an experience to learn from somebody that doesn't have maybe the leadership qualities that you aspire to have. And so you're able to go, "Okay, so this is what doesn't work. Let me figure out what does." [00:11:58] Nile Harris: Exactly. And even the leadership style, even if it doesn't work for you, even if it doesn't work for 95 percent of the organization that person has been put in charge of, that there's something that they do that you might like. So don't necessarily throw the baby out with the bathwater and just say, "Oh, they're a terrible leader." What they're doing something, they did something to be able to get in that, into that position. Learn from that as well. [00:12:25] Lindsey Dinneen: Yeah. Ooh, taking it a step further. I love it. You know, one thing I really enjoy-- oh, I very much enjoyed reading your LinkedIn profile, by the way-- but one thing that really stood out to me, and I would love if you could talk a little bit about was somebody at some point told you that you have an amazing ability to "seamlessly switch between strategy and tactical execution." Could you speak a little bit to that? That is so cool. [00:12:51] Nile Harris: So this is funny. This is a very funny thing. So that was a manager who I did not get along with. We did not see eye to eye. And we had a facilitator come into our team meeting one day and help us to figure out how do we work together and collaborate as a team. Like, how do we pull out the gifts right in each other? And so the facilitator went person to person and asked, "What's your gift? What's your gift? What's your gift?" And so when he got to me, I said, "Oh, my gift is my organizational skills. I'm very organized and I can connect all these dots." And so my manager, who I did not get along with, says, "Your gift is effortlessly going from strategy to tactical execution. You can be in the clouds and then on the ground. And it is a clear stream and it is effortless." And everybody in the room was like, "Yeah, well, where did you get organization from?" I was like, "Wait, where'd you get that from?" I didn't see that in myself. It didn't, it didn't occur to me that's what I was doing. When they pointed it out, I didn't realize it was a gift. Because I just do it. And then they were like, "Not everybody can do that." And I thought it was so odd that this person who I had sort of like this ongoing strife with was the one to point it out. [00:14:27] Lindsey Dinneen: Yeah, that's irony for you, but what a gift though, because then yeah, to understand, "Oh, this isn't something..." I think that happens a lot where you get to it's really helpful to have somebody who's outside perspective who can say, "Actually, this is your superpower because most people can't do what you think just comes naturally to everyone." If only. [00:14:51] Nile Harris: Yes. And 'cause a lot of times I actually got this question, somebody else was going through my LinkedIn profile and they were like, "Well, how did you develop that skillset?" And I told him, "You know, I didn't do it intentionally. I didn't set out to say,' I'm going to go from strategy to execution effortlessly.'" I think it was the act of doing it. So being able to say, "Well, I don't want to be in financial services, but now I have that financial skill and acumen. I'm going to leverage it to change industries." And then being in this tactical position of putting together models and PowerPoints. And I was putting together PowerPoints for like our executive committee. So I'm this very, I'm doing something very tactical, but at a strategic level. And then to go from that to say, "Well, I want to really understand how these things connect together." All right. And so I go to sales. And so I think it was just the, I followed the trail of the curiosity and I learned something along the way by doing that. And so it ultimately, it just sort of naturally, I think cultivated what I do know that I'm really good at is seeing patterns and connecting dots. And I think it just sort of came from that. [00:16:11] Lindsey Dinneen: Yeah, I think that makes a lot of sense. And I think, to your point of you having demonstrated your willingness to continue to learn and to step into different roles, so that you were able to continue to expand your knowledge and your skill sets, I mean, you know, it's funny. And I know a lot of people talk about the idea of generalist versus specialist. And being a generalist does have a lot of advantages in terms of, when you have this crazy diverse skillset and even experience in multiple industries, then all of a sudden you can draw from, "Oh, you know what? I remember this really random thing back in when I was doing financial services that actually would really apply here. I don't, I wonder if anyone has ever thought about that!" And then you keep connecting those dots, like you said, so. [00:17:03] Nile Harris: Exactly. And that's exactly how it happens in my brain. Right? Like my brain will reach back to, "Remember when you worked on this project and you did this really random thing." And I'm like, "Yeah!" My brain's like, "It applies here." I'm like, "Okay." But I did Strength Finders and one of the strengths, it was described as, I didn't necessarily agree with the word that they use, but when I read the description, in the description, it said, "I am a collector of information." And I'm like, yes! I have every notebook that I used to take notes for work. I have every notebook going back to my first job out of college. And I use Evernote to collect, literally collect articles across the internet. If I'm like, "Oh, this is interesting," I'll clip it into Evernote. And so now I've got sort of this encyclopedia of information. And so if I want to, think about, "Oh, I read this article about this medtech company that was doing this thing," I can search my little encyclopedia and find out. So that also is the whole connecting the dots. And Steve Jobs had a, and I'm going to butcher the quote, but he had a quote about "being innovative and being creative is about having enough experiences that you can connect." [00:18:32] Lindsey Dinneen: Oh, I love that. Oh my goodness. Yes. I cannot agree more, and I think the ability to be creative does often come from being able to draw from lots and lots of different sources and then putting them together in a new way. So, oh my gosh, I love this So, you know another thing that stood out in your profile was, you have a wonderful ability to "plan meticulously and then adapt rapidly," and obviously your career path has really demonstrated that but I'm wondering is that in particular a skill set that you developed over time, or have you always had a tendency towards very careful planning, but at the same time holding those plans loosely enough that you can adapt quickly? [00:19:21] Nile Harris: Yeah, there's a little bit of both. It's inherent in me to want to plan, want to know where things are. That just gives me a sense of comfort. I did not always adapt rapidly. That was working in the strategy and corporate development, working with a bunch of C suite, the CEO, the COO, the presidents of all the businesses, adapting rapidly was a requirement. And things would change super fast. The meeting might start off about one topic and then it ends on a totally different topic. So having to pivot, having to go. But then that also helped me with, "Okay, I'm going to have a plan a and plan B and a plan C," because then I started to learn how to anticipate and I would know, "Okay, if we're going to go through this particular presentation, which is about this piece of the strategic plan, it could go one of three ways. And I want to be prepared for all three ways." And so over time, I became known for my ability to pivot real quick or have something in my back pocket. So people would always then be like, "Oh, Nile, we know that you have a plan B. We know that." And we were doing a sales meeting. I worked under the president of the cardiovascular business, and we were doing a sales meeting and his video or presentation clip, whatever was on this sort of --this was a long time ago. So it wasn't transferred digitally. It had to physically be burned onto a tape or a CD or some medium. And I had to physically transport it with me from Minneapolis to Las Vegas, where the meeting was. And I said, " Could you make another one so I have a backup?" And the guy was like, "Come on." And I was like, "Nope." So I gave the first copy to the person I was supposed to hand it off to. Get to Las Vegas, and they called me over to the hall for rehearsal. And they're like, "Hey, we can't find the first copy." And I was like, "No worries." I pull out the second copy out of my little bag. And the president of the business was like, "Yep, that's Nile." And they were sitting there and they said, "Yeah, the president, he wasn't worried at all. Like we were freaking out and he was like, 'Nah, just call Nile.'" [00:21:36] Lindsey Dinneen: Oh. [00:21:37] Nile Harris: And they were like, "Wow." And he was like, "I told you." And so then being in sales is nothing but adapting rapidly. That is what, that is all day, every day. So that adapting rapidly was, it was taught. But I think being planful was my natural inclination. [00:21:57] Lindsey Dinneen: Yeah. Well, what a great reputation, too, to have. "Just call Nile. It'll be great. It'll be fine." [00:22:03] Nile Harris: "It'll be fine. Nile's got covered." [00:22:05] Lindsey Dinneen: I love that. Yeah. So what are you really looking forward to maybe both personally and professionally in the next couple of years? [00:22:15] Nile Harris: Now that I'm in a bigger management consulting firm not doing the independent piece, but I'm part of this bigger entity, there is so much happening in medtech and medical device and life science in general, with generative AI, health care equities, just so much happening. And I think that we are reaching a really a big pivot point also with like digital health care and collecting data and on patient care, predictive medicine. We are at this next evolution of care, and I'm really excited to help usher that in by working with other, with companies, with innovators in this space. The AI with imaging and streamlining workflows and helping to close healthcare disparity gaps, to be able to contribute to that in a much deeper way that you can't when you are a independent consultant. The other piece is, I really love helping to build those high performing teams. And I, there's like with coaching, I love that aha moment, that moment when somebody is like, "Oh, wow." That moment I had when my manager said my gift is going from strategy to execution. I love helping other people have that moment. So I'm looking to help build that next level of leaders that will be better leaders than I am, better leaders than I had. And then that the next stage for me is how do I again, take everything I've learned and pay that forward. , leave a legacy. That's, and I might be talking about like, it might seem like I feel like I'm old because in two years I'm still going to be working. I'm still going to be doing things, but that's when I feel you start to get into the part of your career where you're leaving that mark, you're leaving that legacy. That's the thing that we want to know Nile for in the medtech space. And then really also outside of work, more personally is, I feel very strongly about the health, wealth and education disparity gap and America and being able to contribute to health and equity where we have two demographics of people who get a disease at the same, same rate, but they don't have the same outcomes, the same treatment outcomes. Like, why is that? So how can I contribute to that? [00:24:57] Lindsey Dinneen: Yeah. Yeah. Yeah. Those are all wonderful things to be thinking about and working towards. So yeah, I really appreciate just-- you talked about how you are a servant leader, but you just have such a beautiful heart of service. And I mean, I could see that throughout even your volunteering and your mentorship and things that you do. So, gosh, yeah. Thank you for sharing about that. [00:25:21] Nile Harris: Yeah. [00:25:21] Lindsey Dinneen: So I'm curious. Along this journey, especially in medtech, have there been any moments that stand out to you as really clarifying to you, "Wow, I am in the right place, at the right time, in the right industry?" [00:25:36] Nile Harris: Oh, oh. There is a moment where I almost quit and it was when I was in sales. And again, it was a hybrid sales marketing role, but I was, it was doing my field training and I'm so excited to be out there. And I, you know, completely committed to the mission and we help people in these devices. They go in people and they restore health and they do all of these things and these things are great. And I was, In the hospital one day with one of my training reps, and we got a call to the E. R. There was a patient in there with a ruptured aneurysm, aortic aneurysm, and he was, I don't know, in his eighties, mid eighties. And we looked at the film to see if the device, the stent graft, it's minimally invasive. The other way you repair an aortic aneurysm is to open somebody all of the way up and take out their aorta and put in a different type of graft. And when we looked at the film, this was a ruptured something like a 10 centimeter aneurysm. And this patient was actively bleeding out. And the rep asked me, " What do you see?" And that's what I said I saw. And she said, "Well, okay, so what are we going to do?" And I'm like going through my training, flipping through my training and everything in my training said, "There's nothing that we can do for this patient." And so I say it to her and she was like, "Correct." And so essentially once you've ruptured to this point, they were just making him comfortable at this point and he was going to expire. And I conceptually understood that people pass away. We can't save everybody, but to have to sit there in that moment and look at looking at this film and you are dealing with a human, is a human being on the table and you are saying it's "Wow. This is the moment where you can't do anything." So we left there and I just went back to my hotel and I was like, " This is stupid. Like, why am I doing this?" And my manager called me and I told him, I was like, "You know what? I don't think I'm cut out for this. I can't do this. I can't not save people. I got into this to save people." And he said, "If you had any other reaction, I would be worried about you." He's like, " Give it 48 hours and call me back." So I gave it 48 hours. I called him back and I was like, " No, I'm supposed to be here. I'm in the right place. I love this work. I love what I do. I would not have been so upset if I didn't. If I didn't love what I do, if I wasn't in the right place, I would not have been so upset. So that was to me was a defining moment of that's why I love this work." [00:28:41] Lindsey Dinneen: Wow. Oh my goodness. What a powerful story. Thank you for sharing that. [00:28:46] Nile Harris: Yeah. You're welcome. [00:28:47] Lindsey Dinneen: You know, I really appreciate-- that's such a human moment to have. And of course we all have them, but we don't always talk about them because it doesn't always feel good, but that is so powerful that you were able to take what, it was such a difficult moment but use it as a little bit of motivation for your why as well. Wow. Yeah, that is amazing. Thank you. [00:29:09] Nile Harris: Yeah. And yeah, you're welcome. And I had two primary trainers in Tennessee. They were like in different parts of Tennessee, and the primary trainer told me when I, first day of training, he said, "If you always do what's right for the patient, everything else will come. [00:29:24] Lindsey Dinneen: Yeah, there you go. That's "great. [00:29:27] Nile Harris: Yep. [00:29:28] Lindsey Dinneen: Yeah, well, pivoting the conversation just for fun, imagine that you were to be offered a million dollars to teach a masterclass on anything you want. It can be in your industry, but it doesn't have to be. What would you choose to teach and why? [00:29:44] Nile Harris: Oh, this is such a great question. I don't know how I would do it. But I would teach people how to, how do I put this? I would teach people how to go from like strategy to execution but in a, I think maybe in a broader way, I would teach people like how to connect thoughts or how to be curious or how to always be learning. I don't know exactly how I would do it, but I would teach people to be explorers their life. [00:30:13] Lindsey Dinneen: Yes. Oh, I love that so much. Yes, amazing. Yeah, well, whenever you put that together, let me know because that sounds incredible. [00:30:24] Nile Harris: Yeah. I mean, I just wrote it, like I wrote it down, right? Like, I like, that's what I would do. I would teach people to be explorers, because then if you teach people to be explorers of their own life and curious about their own life, they're going to end up where they're supposed to end up eventually, right? So whether it's medtech or whether it's this or that, like you're going to end up where you should be because you've been curious about your life. And, yeah, that's what I teach. [00:30:52] Lindsey Dinneen: Yeah, I love it. And also, I think the benefit of the explorer mindset is that you are, because you are choosing to view life as an adventure and you're constantly learning and growing, there really isn't such a thing as failure. You're exploring. So if something doesn't go the way that you hoped it would or planned it would or whatever, you go, "Okay, that exploration didn't go as planned. What did I learn from it though?" And then let's move forward. [00:31:21] Nile Harris: Yeah, that's exactly how I look at it. Somebody asked me If I have a fear of failure, and I said, "I don't." And they're like, "That's crazy. Everybody has a fear of failure." And I was like, "No, because I tried something didn't work out. And now I know." Right? Or, "I didn't do it the right way. Now I know the right way, you know?" So I was like, "I don't have a fear of failure. I have a fear of doing things badly, not performing well." But failure? No, it's all exploration, it's all learning." [00:31:46] Lindsey Dinneen: Yeah. Ah, perfect mindset. I love it. So, and then you touched a little bit on this, but just to dive a little bit more into it, how do you wish to be remembered after you leave this world? [00:32:01] Nile Harris: As a servant. Yeah, I, that's a, yeah, I don't think there's more... I want people to remember that I contributed, that I gave more than I got, that I helped others, and I'll be happy with that. [00:32:22] Lindsey Dinneen: Yeah, absolutely. Yeah, and then final question. What is one thing that makes you smile every time you see or think about it? [00:32:32] Nile Harris: Dogs! Dogs! [00:32:36] Lindsey Dinneen: The end. [00:32:37] Nile Harris: The end! See him on the street? Smile. Go to the dog park? Smile. Look at my own dog? Smile. Dogs are our partners in life. They are like four legged dopamine molecules. They are just amazing. And, they're always such a good energy boost, mood boost. Somebody asked me this, " If you quit MedTech tomorrow, what would you go do?" And I'm like, "I would open a doggy daycare." [00:33:06] Lindsey Dinneen: Amazing. I love it. Yeah, they're just little bundles of joy. I mean, how can you not just be so excited to see... Well, I view it that way. How could you just not fall in love? I fall in love all the time with dogs. [00:33:17] Nile Harris: Yeah, the dogs are amazing, I always feel like they make a family complete. I love, and you specifically said "see," so when I see dogs, but I think what gives me energy, I'm kind of, I'm kind of adding a part B to this. I think what personally gives me energy is being around my family. I come from a really big family. And so being able to share that family energy is energizing. But when I see a dog, I'm insta happy. [00:33:46] Lindsey Dinneen: I love it. And I love your part B too. That's a really compelling secondary answer too. So yeah. Thank you for that. So, yeah. Well, Nile, this conversation has been amazing. You are amazing. You're such a powerhouse, and it's, it's such a joy to get to talk with you today and learn from you. So thank you so, so, so much for your time. And we are so honored to be making a donation on your behalf as a thank you for your time today to Opportunity International, which works to end global poverty by creating and sustaining jobs while also providing small business loans, savings, insurance, and training to more than 14 million people in the developing world. So thank you so much for choosing that organization to support. And we just wish you the most continued success as you work to change lives for a better world. [00:34:40] Nile Harris: Thank you so much. I enjoyed our conversation. This was so much fun. Thank you for the invitation. [00:34:46] Lindsey Dinneen: Absolutely. Yes. And thank you so much to our listeners for tuning in. And if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two, and we will catch you next time. [00:35:01] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Dr. Jay Anders, Chief Medical Officer of Medicomp Systems, shares his career transition from an internist to a leader in healthcare IT, emphasizing the importance of usable technology for clinicians. He discusses Medicomp's mission to enhance clinicians' efficiency and patient care through advanced tools. Dr. Anders also explores the challenges of incorporating AI in healthcare, the disparity of healthcare access in rural areas, and the rewarding experience of international medical missions. He highlights the importance of change management in reducing physician burnout and aims to teach coping mechanisms for managing constant healthcare changes.   Guest links: www.medicomp.com | https://www.linkedin.com/in/jayandersmd/ Charity supported: Feeding America Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 042 - Dr. Jay Anders [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to The Leading Difference podcast. I'm your host, Lindsey, and I am so excited to introduce you to my guest today, Dr. Jay Anders. As Chief Medical Officer of Medicomp Systems, Dr. Anders supports product development, serving as a representative and voice for the physician and healthcare community. He is a fervent advocate for finding ways to make technology an enabler for clinicians rather than a hindrance. Dr. Anders spearheads Medicomp's knowledge based team and clinical advisory board, working closely with doctors and nurses to ensure that all Medicomp products are developed based on user needs and preferences to enhance usability. As the host of a popular, award winning Healthcare NOW radio podcast, "Tell Me Where IT Hurts," Dr. Anders has discussed the topics of physician burnout, EHR clinical usability, healthcare data interoperability, and the evolving role of technology in healthcare with a variety of industry experts and pundits. Well, hello, Jay. Thank you so much for joining me today. I'm so excited you're here. [00:01:53] Jay Anders: I'm very glad to be here. [00:01:54] Lindsey Dinneen: Excellent. Well, I would love if you wouldn't mind starting off by telling us just a little bit about who you are and your background and maybe what led you into MedTech. [00:02:06] Jay Anders: Well, I am an internist by training, and after practicing medicine in a large multi specialty group practice for almost 20 years, I decided to have a little career shift, and the reason I shifted careers was I had a little computer science background, so I said, "Let's see if we can put that to work." And about that time is 2004, I'll date myself. We started getting into electronic health records, and when they first started to come out, they were just these read only, do nothings, electronic versions of paper. And I thought, "Well, this is not going to work out really well. Let's see what we can do about that." So my big clinic decided we'd be one of the first to hop in the pool. So we did with a company called Integrate. And when we got that all installed and rolled out and everybody using it, they came to me and said, we really need a physician to really help lead what do physicians want or need in healthcare IT. So I said, "Well, we'll just part time." Well, that lasted about six months. And I said, "I can't be in two places at once. I can't practice full time medicine and do this at the same time." So I switched careers and one of the biggest questions I get asked all the time is "Why in the world you do that?" I mean, I saw, you know, five, six thousand patients a year, big practice. And they said, "Why'd you get out of practice?" And I said, "Well, think about it for a minute. So I can see those five or six thousand patients and affect their lives and help their health get better, or in this industry, I can make the lives of hundreds of thousands of patients better. And not only them, the providers that actually take care of them." So to make a really long pathway short, that company got purchased by another company, which got purchased by a company, probably everybody knows called McKesson. And I worked in the big corporate medicine world for a while. I got kind of tired of that. And I wound up with working with Medicomp. We use some of their products and the Integrate product that we had. So I've known him for quite some time and he always told me, he said, "When you're ready to make a change, let me know." So I was ready to make a change and I joined Medicomp. It's now been 11 years working at that particular organization. Love it. It's great. And it's got the right mission. So I was looking for where can I really make a difference? And this company really makes a difference. [00:04:36] Lindsey Dinneen: That's incredible. Thank you for sharing a little bit about your background. And I'd really love to dive into exactly what you ended with because I think that mission is such a key aspect of maybe a lot of things, and probably opinions vary, but I have found that it is really helpful to have something that drives you so that on the difficult days you go, "Yes, but I am here for this reason." So I'm curious, can you expand a little bit about your current company and how it is so missionally driven? [00:05:08] Jay Anders: Well, Medicomp has a single purpose that has multi facts blended into it. How can I say that a little bit better? It's just, it's got a lot of tentacles, but it does one thing. It was started to actually assist the providers at the point of care to actually take care of their patients. It started out 46 years ago. We're one of the oldest healthcare IT companies out there. We're older than Epic. I love to say that. So we started out to how do you really assist clinicians to, to do what they do. And through multiple iterations and years of development and things like that, we have come up with a set of tools that I think really puts the joy back in the practice of medicine for the providers that have to do it. It also has a mechanism to get the patients involved. So my goal when I first started this is, when I first started looking at electronic health records, I said, "This is not going to work," like I said before. And that's what we're doing now. We're making it work. And it's interesting to see the acceptance or push back, however you want to talk about it. But we have but one mission: is to make the lives of the clinicians that use electronic healthcare work for them. [00:06:29] Lindsey Dinneen: Yeah, absolutely. My mind immediately goes to perhaps some of the challenges that the company faces with these electronic records, things like cybersecurity and HIPAA. And I'm so curious to know how you have been able to navigate that and adapt and evolve because, oh dear, those are hot topics. [00:06:51] Jay Anders: Well, yeah, in healthcare, it's probably one of the most regulated things on the planet at least in the United States. And it just got a little bit more complex because the Office of the National Coordinator keeps rolling out more regulations which we have to comply with. It's interesting how Some of these regulations have morphed throughout the process. I'll take HIPAA as an example. You brought it up. The privacy act had a very simple mission is to protect people's medical records from being shared with the wrong people. It went completely over the falls, meaning you can't share anything. And it's really tough to get permissions and all of that. One of the problems we've had that my company helps solve because we're in the exchange information business is being able to share that medical information when it's needed and where it's needed and in a format that's usable. So when people say, "I don't want my medical record shared," it's interesting because if you really ask patients, they say, "Oh yeah, if my doctor who is in the next town needs what I have, wrong with me, send it. I don't want to have to fill it out again." And one of the biggest bugaboos that I've seen with patients, including myself, is that every time you go to the doctor now, they ask you the same set of questions over and over again. Has that information changed? Probably not all that much. So it spends a lot of time going through machinations of making sure everything is okay and shareable and all of that. I have noticed that lately things are starting to loosen up a little bit along those lines. So people are not so scared that their information is going to get in the right hands or wrong hands, needs to be in the right hands. So I see that kind of fading in, in the United States. And what's interesting is our company is international. So we have installations in Thailand and Indonesia and other places. And over there, there's no problem with sharing information, which is a big plus when it comes to really taking care of patients, and that's why we're in this business as a clinician, either on the healthcare IT side like I am now or on the other side before. It's all about taking care of the patient. [00:09:10] Lindsey Dinneen: Yeah. Yes, absolutely. Yeah, and it's cool to think how you have been one of the first providers of such a service because that must have been, I feel like a barrier of entry would have been challenging. What kind of pain points did you have to solve for, especially clinicians who might have been hesitant to adopt the technology? [00:09:31] Jay Anders: Good question. One of the biggest challenges was the breadth of medicine itself. If you think about all the different conditions that a human can have, you have to have support for all of it. Well, getting to the all of it has taken 46 years. So it's not as if it happened yesterday. So the challenge was actually making it work every time, all the time, for the breadth of medicine. Now, one of the things about physicians especially, nursing not so much, but physicians particularly. We all know that we know everything on the planet and we are the absolute arbiter of everything you have as a patient, and we don't need any help at all. We can handle it. We're trained that way, which is really not true. Even in the old days, I would dismiss myself from a patient's room because I knew I had to go look something up. My knowledge is a little diminished in that area, so I have to go look it up. Well now, medicine's expanded so much that there's no way on the earth you can keep track of it all in your head. So, what can keep track of vast amounts of information, both patient information as well as medical information, pretty easily? A computer! So how can we make that computer act and think like a clinician. And that's what we've done at Medicomp. We've actually done that process. So when you walk in with diabetes or whatever condition, I can give you on a screen everything you need to ask and answer about that particular condition and make it easy for you to take care of that patient and document what you need to document and get all the information you need and sort it out. So computers can do that. It's gotten better through time, and now we have the world of AI we have to deal with in healthcare, which is also a little scary, but it does have a great potential. [00:11:34] Lindsey Dinneen: Well, and to that point, to explore it a little further, what is your opinion of incorporating it? How do you feel that the safety or ethical implications of it, I think there's always a lot of great uses for AI, but I'm curious about how do you feel that maybe it would be best utilized for situations like yours or for companies like yours? [00:11:57] Jay Anders: Well, AI is nothing more than a large program that's trying to predict what the next word will be in any given text. That's what it does, basically, down to the ground. The issues with AI is it's not trained as a clinician. You can read it every medical text on the planet, but it still does not really think like a physician thinks. So, along those lines, it's a great augmentation, easy retrieval of data, easy refreshing your memory about something if it's a little esoteric. It's great at that. It's also great at picking up synonymy, which is picking up every different medical term that you try to use in a particular situation. It can do that very well. The issue is it's not trained medically and it really doesn't have the intuition of a well trained physician So I'll tell you a little bit about myself again. When I started as an intern, I had a white coat with every conceivable little pocket manual I could stuff in it, including my stethoscope and tongue depressors and lights and things like that. I passed all my boards. I knew medical text. I knew all that. But it came down, I have to take care of patients now. A little different. And the experience that I developed over 20 years of doing that is something that you really can't stick into a computer. So, I think AI is going to be great about summarizing different sets of information, filtering it, presenting it, doing things like that. I don't think it's going to be used a whole lot to actually diagnose patients. I've seen people try to do that. It scares me a little bit. The other issue is, who's responsible? If a computer makes a diagnosis, who in the world is responsible? It's not the computer, it didn't care less. It's not the programmer who programmed the computer because they didn't know anything about what you were doing. So who's going to be responsible? So there's that one one step. So it can take you so far. It can really help you to get there, but you have to take the training the intuition, all of the knowledge over time, and apply it. So I think it's going to be a good augmentation, not ever a replacement. I just don't see that happening, at least in my lifetime. [00:14:28] Lindsey Dinneen: Yes, we'll see where it goes, but I, yes, that, that makes a lot of sense, and it's a great tool. I think that's a good way of thinking about it, not as a replacement, but just add it to your arsenal, so to speak, and yeah. Now you are a fellow podcaster and I would love if you would share a little bit about your podcast and how that all came about. [00:14:50] Jay Anders: Well, it's been, oh, it's been three years now. Wow. We were thinking about other ways that we could get the word out about what we do as a company, because my podcast is sponsored by the company I work for. But I also have a little bit of thespian in me. I was in plays in college and high school and all that nonsense. That kind of thing really didn't bother me. He says, "Well, let's give it a shot. What would it be like?" And he said, "Okay." So we had our first guest, second guest, things are kind of coming along. You get into a flow, really enjoy doing it, and the conversations are so stimulating. And then I had my conversation with Mickey Tripathi, who's the National Coordinator of Healthcare IT, and I wound up winning a Power Press Award for that particular interview. [00:15:39] Lindsey Dinneen: Congrats. [00:15:40] Jay Anders: It's been a lot of fun. It's engaging. And the feedback I get from it is that they like the conversation. Everybody likes to talk at you, not with you. And I've really tried to get out of that mode of just talking at somebody, but let's have a conversation about a topic. And I've learned a lot. I hope my listeners have learned a lot and it's been a great deal of fun. [00:16:08] Lindsey Dinneen: Yes, that's great. And I also recognize that you are a featured speaker on healthcare IT. And was that, well, you said you have this background in theater. So was public speaking something that came easily to you? Was it something you developed over time? [00:16:28] Jay Anders: It came pretty easily to me, I think. One of the things I did back three companies ago is I got to introduce a keynote speaker and talk about a keynote speaker in front of an M. G. M. A. Conference, and there had to be 6000 people in that audience. It was huge. But I walked out there and I said, "Okay, they're gonna listen to what I'm gonna have to say, and that's gonna be it. It's not gonna affect me." And it was a lot of fun, too. But so big crowds like that, it really doesn't affect me if I'm well prepped. If I'm passionate about talking about, it kind of rolls out of me naturally. So I don't have any problem with it. It's a lot of fun as well. [00:17:12] Lindsey Dinneen: Good. Yeah. Yeah. Just another opportunity to continue spreading that message. You know, I very much enjoyed looking at your LinkedIn profile and learning a little bit about you. And I wondered if you could share a little bit about, I saw that you do or have done in the past, some medical mission work to various countries. I would love if you would share a little bit about that and your heart for that. [00:17:38] Jay Anders: Well, in the past, I've not done it a lot recently, but I have taken several trips to Asia with a medical team and it had to be one of the most rewarding things I think I've ever done. And we were in the country of Kazakhstan, and we were seeing people who really don't have access to healthcare. And what healthcare they have over there was really not all that good. But we went over with a team of five. Had a physical therapist, a nurse, and probably 15 bags full of medications of which all went through customs without a hitch, which I was very surprised. But I got up in the morning, got there right at daybreak, and I would see 250 people a day and work till the sun went down. And there were still people to see. They were so appreciative of any kind of information, any kind of healthcare, any way you could help them. All done just, it was, like I said, one of the most rewarding things that I think I've ever done. And one of the best parts about that trip is I went and went to an orphanage that had, the kids needed health screenings. And there were about 200 kids. So we started early in the morning and I saw child after child after child after child ' till we finally got through the whole thing. And at the end of the day, it's now hanging in our kitchen. One of the little boys came up and said, "I want to give this to you, doctor." And it was a wooden plaque of an, with an urt on it, a camel and a little star. And in that part of the world, that's how they live is these urts, these very unique, tent like structures. And I just broke down. I couldn't, I, it was one of those things where that is going to me, to the nursing home because of that experience. But I highly recommend if anybody in healthcare and I'm not part of Doctors Without Borders, but I support them. If you have a chance to do that, do it. And you can do it as a non medical person because you always need support people. So if you think you want to do it, get yourself involved. It's great to do. It's massively rewarding and an experience that will last you a lifetime. [00:19:59] Lindsey Dinneen: Yeah, life changing. Yeah. Thank you for sharing about that. I thought that was really neat to see that's something that you've done in the past and you're passionate about. And speaking of passions, I know kind of a similar thing, but I think perhaps even in the US, this is something that you advocate for is, something that seems to bother you is the disparity of access to healthcare in more rural settings. And this is something that I feel like, on occasion, maybe some Americans don't realize that even in the United States, there is this disparity. And I was wondering if you could talk a little bit about that and your passion for that. [00:20:37] Jay Anders: Oh, absolutely. I grew up in a town of 20, 000 in the middle of Illinois. And I'll just give you a little progression. So in the town I grew up in, when I was a little boy at six, seven, we had two hospitals, nice size hospitals in that community. Roll ahead to 2024. One is a derelict building that looks horrifying. It's about to fall down. The other has merged with a larger system, which is about 40 miles away. It's coned down in size. They still do a lot of work there, but it's a lot of the major cases get shipped out to the mothership, which is in an adjacent city. But this plays out across rural areas all over the country. Hospitals are closing, they're under pressure, both cost of care as well as reimbursement for that care. Specialists in certain areas are very hard to come by. And when you look about the delivery of care, this is one of the things that bothers me the most. The people who get better in the hospital the quickest are the people who have support groups around them. They have parents, they have children, somebody to come and visit them and be with them, give them a reason to get better. When you move some of these rural hospitals and put them out of business or reduce them to the point they're just an aid station and you ship that patient to a medical center that's 50, 100 miles away, that support group goes away. It's very hard for that to even exist. So if you take into consideration the lack of real reimbursement at that level, at those types of hospitals, the lack of specialty care, which is still needed, and really the lack of primary care, things are headed downhill with that as well. It really is a disparate way of delivering healthcare in the United States. Not everybody can go to a Cleveland Clinic or a Mayo to get their healthcare. I live here in Western Pennsylvania. We have two massive institutions, both of which are wonderful, but not everybody can come here. People that are out in the Northern Pennsylvania, in the middle of the state, they got to travel because their hospitals are closing. And that I think is a travesty of the system. It's something that needs governmental intervention and it needs intervention in several different modes, meaning increased reimbursement, training physicians that want to practice in that type of environment. There are programs out there that are to start to do that, but it needs attention because people out there are not getting the same healthcare as I can get 15 miles up the road in the city of Pittsburgh. [00:23:28] Lindsey Dinneen: Yeah. Yeah. Thank you for sharing a little bit about that, and even some suggestions for ways that this can be helped. I know it's a long road, but I appreciate that you are bringing light to it and helping to start those conversations that will hopefully lead to change down the road. So. [00:23:49] Jay Anders: And technology does have a place to play in doing that as well. Telehealth, distance, ICUs, things like that. There are ways that technology can augment that medical care, but it's expensive. There has to be some type of support for it, both at the state and federal levels. [00:24:09] Lindsey Dinneen: Absolutely. So I'm curious on your path and your journey so far, and obviously you've had a really interesting career path 'cause you've done a few different things over your career and you continue to, I'm sure, learn and grow. But are there any moments that stand out to you as really affirming that, "You know what, I am in the right industry at the right time, at the right time? I'm doing what I was meant to do." [00:24:36] Jay Anders: Boy, that's a great question. One of the things that really drew me to working at the company I'm working at now at Medicomp was the fact that they truly had the physicians and the providers of healthcare's best interest in mind. Foremost, everything we do, and I mean, everything we do, is geared to make their lives better, more effective, and deliver better care. That's what we do. So in my pathway, which came kind of went around in different ways and different companies, different sizes through acquisition and other things, I really wound up in a place where we're not a large company, but we're all of one mind. And that is an absolutely fabulous place to work when you're all pulling the rope in the same direction. And it's all for a great purpose. And when I have providers come up and tell me, "Well, we installed this or we're using this, and it really did help what I'm doing." I had nurses come up to me and at one of our installations that say, "I've got 50 percent more time to spend with my patients. I'm not spending it in an inefficient electronic health record. That's been fixed." And when people say that it's like, "Okay, I'm in the right place at the right time." [00:26:04] Lindsey Dinneen: Yeah, that's incredible. What great testimonies too. Oh my word. Thank you for sharing that. So pivoting the conversation just for fun. Imagine that you were to be offered the opportunity to teach a masterclass on anything you want. It can be in your industry, but it doesn't have to be. And you'll get a million dollars for it. What would you choose to teach? [00:26:30] Jay Anders: I would teach physicians and other clinicians change management theory and how to manage change. That's what I would teach. I've had the luxury in my career of having a professional coach for two years, professional training and leadership. It's been a great thing to have, but not everybody has that. I would love to be able to teach clinicians how they can manage all the change that comes at them every day. It's patience, it's technology, it's knowledge base, all of that. It's changing all the time. You got to have a method. You got to have some skills. You got to have some coping mechanisms to go through that. It can't overwhelm you every time you go to work. And I think that's part of our burnout problem is that there's the skill set of managing change just isn't there to the degree it ought to. And physicians throw their hands up. I'm going, "I'm retiring. I'm going somewhere. I can't do this anymore." And I think that's wrong. So, that's what I do. I would teach coping skills around change in healthcare. [00:27:46] Lindsey Dinneen: I love that. Excellent. And then, how do you wish to be remembered after you leave this world? [00:27:53] Jay Anders: I want to be remembered as somebody who made a difference. You know, a lot of people get into the healthcare IT business because they want to revolutionize this or revolutionize that. I don't want to revolutionize anything. I want to make a difference. And if I can make a difference, I've pretty much done what I went into this profession to do was make a difference with patients, make a difference in my colleagues, and in the industry I'm in now. That's what I want to be remembered as. [00:28:23] Lindsey Dinneen: Yeah. Yeah, I love that. And then, final question. What is one thing that makes you smile every time you see or think about it? [00:28:33] Jay Anders: I'm going to go back to my story in Kazakhstan. Every time I think of that little boy coming up, grabbing my coat, jerking on it, to hand me that little plaque, that gives me a smile every time I think about it. It actually gives my wife a smile, too. Because we'll look up at that plaque in the kitchen and go, "I know where that came from. That was a good time." That makes me smile almost every time. [00:28:59] Lindsey Dinneen: Yeah. What a powerful memory and just such great motivation, something to come back to on the difficult days and then you look at that and go, "Yeah. Okay. I can make a difference here. I did make a difference here." [00:29:14] Jay Anders: I did. [00:29:15] Lindsey Dinneen: I love that so much. Well, this has been an amazing conversation. I am so grateful to you for spending some time with me and just telling me about your background and the amazing work that you're doing, that your company is doing. And we are honored to be making a donation on your behalf as a thank you for your time today to Feeding America, which works to end hunger in the United States by partnering with food banks, food pantries, and local food programs to bring food to people facing hunger, and they also advocate for policies that create long term solutions to hunger. So thank you for choosing that organization to support. And we just wish you the best continued success as you work to change lives for a better world. [00:30:00] Jay Anders: Thank you. It's been a pleasure. [00:30:02] Lindsey Dinneen: Absolutely. And thank you also so much to our listeners for tuning in. And if you're feeling as inspired as I am right now, I'd love it if you would share this episode with a colleague or two, and we will catch you next time. [00:30:16] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

In today's episode, we will be talking for a 2nd time with our good friends, Axel Wirth and Chris Gates.  Axel is the Chief Security Strategist at MedCrypt.  Chris is the Director of Product Security at Velentium.  Together, they have authored a second edition of the book Medical Device Cybersecurity for Engineers and Manufacturers (https://www.amazon.com/Medical-Device-Cybersecurity-Engineers-Manufacturers/dp/1630818151). When you go to the site, you can get 25% off using the promo code WIRTH25.You can connect with Axel and Chris in the following way:LinkedIn: https://www.linkedin.com/in/christopher-gates-8912a81aLinkedIn: https://www.linkedin.com/in/axelwirthAt Tech & Main, we want to be YOUR technology partner. Let our 20+ years of expertise help you achieve the outcomes that are best for your business: cybersecurity.  We have engineers and project managers available to assist you. Call our office at 678-575-8515, email us at info@techandmain.com or visit us at http://www.techandmain.com/.  Thanks for listening!

Hannah Went, a pioneer in epigenetics, is the co-founder of TruDiagnostic and founder of Everything Epigentics. She shares her journey from the early days of TruDiagnostic to its burgeoning role in healthcare. She reflects on the rapid evolution of epigenetics, the challenges of making groundbreaking science accessible, and the gratifying shift towards mainstream acceptance. Hannah also delves into her personal growth, emphasizing the transformative impact of "The 15 Commitments of Conscious Leadership" and her desire to be remembered as loving and impactful.  Guest links: trudiagnostic.com | everythingepigenetics.com Charity supported: Equal Justice Initiative Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 041 - Hannah Went [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and I am so excited to introduce you to my guest today, Hannah Went. Hannah has a lifelong passion for longevity and breakthrough disruptive technologies that drive radical improvement to the human condition. She attended the University of Kentucky and graduated with a degree in biology. During that time, she had multiple research internships studying cell signaling and cell biology. After graduation, she worked for the International Peptide Society as their Director of Research and Content. Through work in the integrative medicine industry, Hannah saw an opportunity for a methylation based age diagnostics and started TruDiagnostics in 2020. TruDiagnostic is a company focused on array based methylation diagnostics for life extension and preventative healthcare serving functional medicine providers. TruDiagnostic has a commitment to research with over 30 approved clinical trials investigating the epigenetic methylation changes of longevity and health interventions. Since TruDiagnostics' inception, they have created one of the world's largest private epigenetic health databases with over 75, 000 patients tested to date. Hannah has since created Everything Epigenetics, where she shares insights on how DNA regulation has an impact on your health. All right, well, welcome to the show, Hannah. I'm so excited to talk with you today. Thanks for taking some time. [00:02:14] Hannah Went: Thanks, Lindsey. I'm excited to speak with you. [00:02:17] Lindsey Dinneen: Awesome. Well, would you mind starting off by sharing a little bit about yourself and your background and what led you to MedTech? [00:02:25] Hannah Went: Yes, absolutely. I've known since I was a little girl that I've always been interested in science, how the world works, how the body works. I remember being a little girl and going in our backyard, lifting up rocks, finding roly-polies and worms and getting all down and dirty. I was definitely a tom girl, if you will, growing up. I love sports. I loved connecting with people. So I also loved the social aspect of understanding how the body works as well. And I was very athletic growing up. So I played track soccer, basketball, sports all year round, essentially. I knew I wasn't good enough though, to go to like a D1 or probably even D2 college for sports. So I was like, "All right, well, I'll just go to a larger university, maybe play some club soccer and really focus on my academic route." And I ended up going to University of Kentucky. It wasn't too far from me. I'm just from Ohio, north of Dayton, a small town called Piqua. And I did end up playing soccer, club soccer there, got involved in a lot of other activities. Ended up actually going into veterinary work, animal science. UK has a really good program for that. They have a really good agriculture department. I ended up shadowing a vet one summer and I hated it. It was one veterinarian clinic. So a lot of work, a lot of late hours. And I knew I wanted to have a family growing up. So I was like, "Eh, let me just switch to general biology. Let me just open my doors." And fast forward to senior year. I was really interested in genetics and you know, how do we have these predispositions that are passed on throughout our family? How does that affect our health outcomes essentially? So I applied to genetic counseling school, which is a very new program. It's a master's program. It is where you get your master's essentially in genetics and counseling. So it's like the best of both worlds, exactly what I loved growing up. You have the science aspect, but you're sitting down and helping people actually understand their risk. Applied to school, Lindsey, and didn't end up getting in. So I was like, "Oh, I'm heartbroken. I'm still super young. My life's over!" type of deal, a big eye roll ,and thought it was the end of the world. But really where my career took a huge turning point was at that failure point. I took a job, my best friend got me a position at a compounding pharmacy in Nicholasville, Kentucky, which is just a little bit South of Lexington. And that was when I was opened up into this entire medtech space of healthcare providers and the integrative functional medicine journey who were focusing on healthcare, like true healthcare, not sick care, not taking care of sick people when they're already sick, they're already doomed and just trying to bill them for all of these medications through insurance. So that's really how I've gotten to where I am today. [00:05:23] Lindsey Dinneen: Oh, that is so cool. Well, first of all, thank you for sharing a little bit about your background. It was fun to even hear about your childhood and how that theme of interest in all those different aspects has woven its way through your story. And I would love to hear a little bit more then about, okay, so what does present day look like and how did you end up where you are? [00:05:43] Hannah Went: Yes, so I'll try and keep it short and concise. So this pharmacy was very innovative. It was the fourth fastest growing healthcare company in the nation in 2019. And it's really focused on the unique peptide products. It was again a compounding pharmacy by trade, meaning you can compound anything in all different dosing as long as you have a prescription from a healthcare provider by it. They grew really fast. So, you know, we always had regulatory agencies come check in, make sure we were doing everything correctly, which we absolutely were. But there was always this worry that these products made people feel better, but there wasn't a lot of quantitative data behind it. So we were like, "All right. Well, what can we measure in clinical trials and institution review boards to really prove to people out there, 'Hey, these are having a massive underlying biological effect on people.' They don't just feel better." We used to joke and say, "People can become tan, they can become skinny, they can increase their libido from these products, but they also actually save people's life." They stabilize insulin sensitivity. They can help people lose weight who have metabolic disease. They can mediate a lot of the effects of specific autoimmune diseases. So there are massive impacts that these products had. And we're like, "All right, well, if you had one test, like if you could measure one thing that really relates to all of those items I just mentioned, it's aging," right? These age related diseases. So, "how do you even measure age" is the follow up question and you can do that in all sorts of different ways. But there are actually these DNA regulation markers, like these on and off switches, called your epigenetics that seems to be the best way to measure aging. So we really started measuring and doing clinical trials with these epigenetic aging biomarkers to prove the efficacy of these products. And what we ended up doing is just selling the pharmacy in 2019. It became-- oh-- pretty boring, I guess, for lack of a better word, because there were new rules and regulations in place by regulators on what you can and cannot compound. And then you have built my company now, TruDiagnostic, from the ground up. We have our laboratory in Lexington, Kentucky, and we started out with one goal, which was essentially to offer the best age testing. And now we're doing a lot of different things. So that's what I'm really involved in now on a day to day basis. [00:08:10] Lindsey Dinneen: Wow. Well, thank you for sharing about that. And okay, so, so you embrace this entrepreneurial endeavor, which is a whole second set of-- I mean, obviously you have all the skills from your experience and your education and whatnot, but then to compound that with owning your own business and then setting up a brick and mortar, it's an actual lab and whatnot. How was that transition? Did you feel prepared for it? Did it catch you off guard? What was that like? [00:08:38] Hannah Went: We were kind of creating TruDiagnostic behind the scene when we had the pharmacy. So like end of 2019, we were really creating it. But I do think it caught me off guard looking back where it was like, "Okay, pharmacy sold, full time TruDiagnostic. How the heck do we set up this lab at the beginning of 2020?" It was go mode. So we bought a building in Lexington. It was an old insurance building. We completely knocked out the top floor, which was offices, carpeted, not usable lab space and built the lab again, like I mentioned, from the ground up. So I joke and say, "I'm a construction worker. I was an interior designer." I was doing all of these other things. And of course I had a lot of amazing people helping me all throughout the way, but testing SOPs for standard operating procedures, creating those. I remember the first day we were running samples in like trialing the protocol. I was here till 5am because we were thawing things and freezing things as part of the protocol and didn't even realize that was part of the step once we started to get into it. So yeah, it definitely took me off guard. And I think furthermore, we launched right before COVID 19. So it was the worst timing in history to launch. And you know, we did it anyways. And then the first year and a half, two years, it was a lot of follow up. It was a lot of cold calling. It was chasing or following up with these healthcare providers to use these kits that we sent out because we did a really nice promotion to get the product out there, but it was hard to balance because when COVID 19, this nasty pandemic, came into the U. S., you almost felt guilty asking the healthcare providers to focus on anything else, right? You're like, "That is not what you should be worrying about right now." So it was definitely hard to balance. [00:10:23] Lindsey Dinneen: And yeah, my goodness. And honestly what resonated with me too is, you know, you're talking about, you've worn so many hats, obviously, as a business owner and setting this up. And I used to joke that, when I had a brick and mortar business and I was like, "On any given day, I'm everything from the CEO to the janitor." [00:10:40] Hannah Went: I can relate. I can definitely relate to that. I remember we needed some kind of-- I don't even know what we need this for-- it was like some type of part that had to regulate water temperature or something like that. So a traditional thermometer wouldn't work. I remember I drove across the street to a pet store and I got something that belonged in a fish tank. And I'm like, " I don't even know if this will, will work." But I mean, we are just piecing everything together. It was like you were doing yet literally everything and anything that you could just because you wanted it to work so bad. You had that passion, that, that push. And you realized that the end goal in mind, which for us, it's really just to help our people, you know, people who are working with us, and our clients, whether that's anyone from now a healthcare provider offering our services or a researcher or academic collaboration, it's someone doing third party processing at our lab or even down to the end consumer client patient, whatever you'd like to call them that come directly to our website and do our testing. [00:11:40] Lindsey Dinneen: Yeah. Great. And that actually addresses my next question, which was going to be, so do you only work with healthcare providers? Is it a B2B enterprise? But it sounds like you also do the B2C and you can sell directly to them, to people who are interested. [00:11:55] Hannah Went: Definitely. Yeah. When we opened, we had that one goal in mind, which is what we knew, which were our healthcare providers that we really transitioned from the pharmacy over to TruDiagnostic. So that was like our main customer at the time. And I think we completed that goal of offering the best aging diagnostic tools at the end of last year with a large study we did with Harvard. But now what we've noticed and, of course-- we kind of got lucky in this sense, we would have never imagined where we are now-- is that epigenetics, these DNA markers, these on and off switches are really great for creating new and novel biomarkers. So you can predict almost anything with them. You can predict even how much you've smoked across your entire lifetime, how much alcohol you've consumed, your zip code based on where you live, just because of the environment you're exposed to and your behaviors in that environment. So it's pretty crazy, obviously we, we didn't expect that and I mean it's just being really blown up and everywhere you, you look, I mean it's related to every aspect of life and of course changeable as well. So even, providers who are using this test on a patient once, they'll retest them every 6 to 12 months. And then of course people coming from our website, we just released actually a subscription model a couple days ago so people can start to retest this in more of a hands off fashion. even every three to four months if they wanted to. [00:13:19] Lindsey Dinneen: Wow. So when somebody does your test and they get the results, is this something that you walk them through and say, okay "Here's where things stand now. If you make these tweaks, here's how things could stand?" Or how does it work from that perspective? [00:13:34] Hannah Went: Definitely. So just to walk you through the process, you would get your kit, we'd ship it to you, you would prick your finger. So just a little blood spot card about the size of a quarter, you ship that sample back to our lab in Lexington and we get results back to you in about two to three weeks from the time we receive it. Then you would get all these different age related reports, some of those characteristic and trait based reports I mentioned, like this smoking and alcohol. And we, we do, so we can project you out saying, "Hey, if you still stay on this trend, whether it's aging faster or aging younger, here's where you're, where you'll be in six months, 12 months." So it may be exciting to some, it may be scary to some, depending on where they are. Regardless, it's changeable. So if anyone's listening and they're like, "Oh my gosh, I don't want to know that. I'm so scared." If you've tested your genetics, that's in my opinion, even scarier. That doesn't change, right? You know your risk, you know your predisposition. So, this can all be mitigated through lifestyle factors, through supplements, medications, procedural based therapies as well. So we do give you recommendations on the report on what to do. You can absolutely again take it by yourself, but we can always help you and connect you with a healthcare provider if you're really wanting to go on this journey. But I always say, Lindsey, the first test is really fun. It's sexy. It's really trendy right now. But it doesn't mean much. It's just a baseline. It's telling you where you are, just like your hormones and your CBC panel, your second test is more important than your first third, more than the second fourth, more than the third. And so on and so forth. [00:15:09] Lindsey Dinneen: Okay. Yeah. And you addressed something else that I was going to ask. So when people are interested, they'd like to do it, but they have this like, "Ooh, I don't know if I really want to know," how do you help overcome that? Is it because things are changeable? Like everything can be changed? [00:15:26] Hannah Went: Yeah. Yeah. I'll even give you to an extent, I would say most of it, right. For the purpose of this conversation, yes. There are of course some exceptions, but my grandmother, for example, passed away from Alzheimer's when I was senior in high school. Right after that happened and what started some of my interest in genetics is I went and got my genes tested. I'm like, "Oh my gosh, that was awful to watch her go through. Am I doomed, right? Am I going to have that same risk?" And my results came back. Well, I have this specific snip. It's a single nucleotide polymorphism. So this specific variant on my genes that's APOE 3-4. So this means I'm at a more increased risk to have Alzheimer's, and even at a younger age as well. I would say you have an even further increased risk if you're at APOE 4/4. So I'm not the worst, but I'm the second worst, essentially, and I'm like, "Well, this obviously isn't good. But this can't be it, right? This can't be the end of this story." And you hear a lot of people say that too, people with metabolic disease or diabetes in their family. And, they may shrug and just say, "Oh, well, you know, I can eat whatever I want, right? I don't have to work out, like I'm doomed anyways, type of thing." And we know now that's not true, right? You're no longer really the victim of your genetic predisposition that we may have thought due to these epigenetic changes or the fact that it's changeable. So there are even peer reviewed published papers that come out showing estrogen, so optimizing your hormone levels can actually reduce your risk of Alzheimer's from an epigenetic standpoint along with everything else, exercising, eating very healthy, no artificial foods, flavoring. So you're, of course, always going to have that genetic risk, but you also have all of these other types of risks and you have this epigenetic risk, which should really be the main focus, because you're in the driver's seat again. You're no longer in the passenger seat. And that's really empowering to have all of that knowledge. [00:17:22] Lindsey Dinneen: Yeah. Yeah, absolutely. I know that the test is really important in terms of telling an individual exactly what's going on and how things can change, but in doing all this research and data collection, are there certain lifestyle things that pretty much everybody regardless should pay attention to. Is that a thing? [00:17:45] Hannah Went: Of course, that's the multimillion dollar question and a very frequent one that we get. And the answer is, "Sure, yes and no, kind of, maybe so." And what I mean by that is you can look at all of these general population studies that come out, right? These clinical trials and look at what really moved the needle. But again, those are populational trials, so you really need to find out what works for you. I can tell you what works for me. There is a study on this, which is why I wanted to try it first. So again, you can start to maybe trial some things based on results that are already out there, but I've tested my aging before and what I've noticed that really slows it down is caloric restriction. So it's not necessarily intermittent fasting or time restricted feeding or skipping an entire meal, it's just continual, 10 percent caloric restriction. So if you're on a 2000 caloric based diet, take out about 200 calories, which if you're eating healthier anyways, you may not even be hitting your intake of calories based on your metabolic rate and what your specific goals are. And I've noticed that helps slow down my aging. I've also noticed that I need to do more aerobic based exercises. So things like VO2 max, increasing FEV1, we can actually quantify those on our test. So really VO2 max is your oxygen uptake, so how much oxygen you can get into the body. Your FEV1 is your forced expiratory volume, so how much oxygen you can get out in and out of your lungs. Swimmers have a really good VO2 max and FEV1. So I noticed I was doing maybe too much like weightlifting, too much HIIT type of workouts. So you can get a lot of feedback from those reports. So for me, personally, that's what works. [00:19:30] Lindsey Dinneen: Wow. That's great. That is amazing what you can test and gain knowledge about and then make those changes based off of. So on your LinkedIn profile, something that I was really intrigued by is you are a founding member of an organization, I believe, called Opscotch. Did I get that right? Okay. And one thing that really stood out to me, and I'd love to just hear your take on the organization as a whole, but you said part of your mission is to make biohacking accessible to everyone. And I really appreciated that. And I'm curious if you would share a little bit maybe more about that. [00:20:05] Hannah Went: Yeah. Obscotch is a really cool community. So it is really democratizing the way healthcare I think has been viewed, even healthcare, like the model where we should go towards rather than that sick care. So it's making it a lot less scary. And I know that the founders of Obscotch, Spencer Coppin and Matt Christensen, and they're amazing people. They really set up this community as a way for people to have a support system. I think it can be really scary when you're entering really optimizing your overall health, what do you do? You see all of these ads, what protein should you take? What supplements should you take? They're just everywhere. Whose supplements really match the label? There are a lot of studies that show, that they don't even have promised ingredients on the label included in the supplement itself. So it's really confusing. And then you go down these rabbit holes and after a while, you don't know what you're looking at. So if you're part of this community, you can choose to get a Whoop and to start tracking a lot of these markers. You probably know the quote by Peter Drucker, "You can't manage what you're not measuring," so they measure a lot of things. They do the biological age testing through TruDiagnostic, and then they do some other laboratory based testing as well. So there's different levels of the membership that you can actually get depending on how involved you want to be, but they also do these monthly quarterly type of challenges. So it could be to get your Whoop fitness score above 12 for 15 days of the month. So again, it really encourages people to come together and I love that community aspect of it. They've done a really nice job. And again, are just amazing people there. They're located in Canada too. [00:21:46] Lindsey Dinneen: Oh, nice. Yeah. So taking ownership of your health, but within a community, which makes it a lot, well, more fun, at least. [00:21:54] Hannah Went: Yeah. And the community is awesome. That's probably a really good group for you to even look into, Lindsey. It's a lot of founders and entrepreneurs and people who have like wild backgrounds. And they're from all over the world too. So it's not just like, oh, you have to be in Canada. They do have a lot of like local meetups in Canada, which is really cool for things like cold plunging or running or, you know, scheduling dinners or seeing like Andrew Huberman, he was in town like a couple of months ago or something. So they put together the events and they also send you even like recommended podcast or YouTube videos to watch. So it's really curated health information if you're looking to optimize your own health. [00:22:35] Lindsey Dinneen: Wow. Amazing. Yeah. And then, so another thing that I really enjoyed reading about you and your experience is, you mentioned that you appreciate taking complex scientific ideas and translating them into narratives that resonate with the intended audience. And I love that, and I think that's really important, but I'm wondering if you could tell us a little bit about your process in doing that, translating very technical engineering science speak into maybe what other people who aren't in that world could relate to. [00:23:14] Hannah Went: Yeah, definitely. So I have my personal company too, called Everything Epigenetics. So this is a, something TruDiagnostic wanted to do for a while is just educate others on epigenetics and what that means because there's a lot of education lacking out there. There's not much you can find. With all things that kind of got pushed under the rug in our early days, but I was just, " Screw it. I'll just make it mine." And I set up all of the social, the website domain and didn't do much with it for the first couple of months. And I was like, "Okay, I really want to get into this." And I think I started it at the end of 2022, so almost two years, which is crazy to say. And, I used it as a way to really keep myself honest and involved in the research. So I'm not as involved in our research on a day to day. So I work with a lot of postdocs or PhDs who have created epigenetic algorithms or interpretations. And basically, hopefully break those conversations down for people to easily understand. It's still very high science and not as applicable, so it can be tough sometimes. But my real goal is just educating those on this massive paradigm shift we're seeing with epigenetics in terms of not only taking over traditional lab testing, but just medicine in general. I mean, it's causing a massive wave and really, I think, flipping our understanding of how this field works, how even really the body works. So I don't monetize that at all. It's just something I do on the side. I have a podcast that runs every other week. And then I also am pretty active on Instagram doing these Journal Club Friday kind of spiels. That's where it's usually a video that's anywhere, I think, they're at least 90 seconds, but 90 seconds to four minutes long, just highlighting some type of research paper in the space and trying to do it in really simple terms that way people can understand it. So it's not maybe always going to be applicable to everyday life. I think it's absolutely going to get there where we are able to measure epigenetics, see our exact plan, have everything served us on a silver platter. But we're a little bit far away from that now. And I think that's can be really frustrating to some people, but I think it's also as equally as exciting. And you have to keep in mind that this came out after the iPhone, after the first iPhone. So it only came out about, or I would say only became popularized about 10 years ago, which is very new. So we just have to be a little bit patient. [00:25:51] Lindsey Dinneen: Yeah, that's fair. Well, thank you for helping translate some of these crazy things into more digestible pieces of information for those of us who maybe don't have that same background. So I do appreciate that. [00:26:05] Hannah Went: Yeah, of course. It's really fun to just continue the conversation and start to break these complex ideas down. [00:26:12] Lindsey Dinneen: Yeah, absolutely. Yeah. So, within your journey you know, as a scientist and researcher and entrepreneur and everything else, are there any moments that stand out to you that, that really affirm to you that you were in the right place at the right time in the right industry? [00:26:34] Hannah Went: Ooh, that's a good question. I, I think yeah, I think probably a couple months ago, three months ago. So, we've actually joined with some other clinics on really pushing forward epigenetics. And I think we're starting to see everything coming together. So I think it is hopefully becoming mainstream. And that is just huge, because the vision for epigenetic testing is to be able to use one blood spot card, so really simple, easy collection method at a really cheap cost and getting every single biomarker back that you could possibly imagine: clinical lab values, hormones, inflammatory markers, vitamin levels, minerals, proteins, metabolites. And I think, I remember just a couple months ago, when we really started to get an increased volume and testing, more healthcare providers just saying yes and super open to this idea. So I usually spend my day to day on calls with healthcare providers or our partnerships that we have with, whether it be wholesale or like resellers of these kits. And people are just starting to get it more. Like I remember at the beginning of TruDiagnostic, we always had to set up a call with every single account. It was, Hey, start from the top. What is epigenetics? Even before epigenetics, what is aging? How do you measure this? This is a really weird idea. And now we're starting to see where people set up accounts with us and they don't even set up a call and they just start ordering, right? Or they set up a call and they're like, "Hey, I know what aging is. I know what epigenetics is. Help me market this to my patients. How do I sell this?" So, so we're starting to see that change and that's definitely not been overnight. To answer your question, right time, right room with the right people. But I think probably at the beginning of this year is when we started to really see that change, which has been super exciting. [00:28:35] Lindsey Dinneen: Yeah, that is. It is because it's hard to-- it's great to educate-- but it is hard when that is your entire job day in and day out. And eventually maybe the science will catch up or the understanding of the science will catch up so that you finally get to this, you know, "we're getting there" stage. [00:28:54] Hannah Went: I think it's hard, yeah, because you know, with us we speak with the healthcare providers. We speak with the academics, but we may not actually be seeing the end user, the end patient. So sometimes it can be hard. It's like, "Hey, what difference are we actually making?" And that can be a little bit of a pain point or a struggle. I think not so much anymore because our providers will come back and give us case studies or, you know, talk to us about some of their findings, which is really exciting. And that, continues to expand as we do these clinical trials and dive deeper into the research. But I think we're TruDiagnostics sits right now is just an awesome opportunity because we are in between collaborators in terms of universities and academics and healthcare providers and patients. So we really bridge that gap as new algorithms, as new research is happening. We really do feel like we're at the centerfold and it's our responsibility to push that out to healthcare providers because there's no one really there to merge the two. So we'll start to see our type of healthcare providers we work with are willing to try anything, and willing to want the newest, latest, and greatest information as well to test on their patients. So they make for a really great group. [00:30:04] Lindsey Dinneen: Yeah, that's incredible. And it's so great to hear about the ability to bridge the gap between an individual being able to take ownership of their own health versus-- doctors are amazing. I'm so thankful for every medical person-- but also it's nice to be able to feel a little bit empowered to take ownership as well. So I appreciate that you're able to start bridging the gap and, and help them make be more accessible. So that's great. [00:30:30] Hannah Went: Yeah. Yeah. Definitely. [00:30:32] Lindsey Dinneen: Yeah, so, pivoting the conversation just for fun, imagine that you were to be offered a million dollars to teach your masterclass on anything you want. It can be in your industry, but it doesn't have to be. What would you choose to teach and why? [00:30:47] Hannah Went: Ooh. What would I choose to teach and why? I think the ,there's a book that's really good that I think everyone should read and it's called "The 15 Commitments of Conscious Leadership." And have you ever heard of it before, Lindsey? [00:31:00] Lindsey Dinneen: Nope, but I'm writing it down. [00:31:02] Hannah Went: Yeah. It's awesome. So there, there are a couple of authors on the book, but yeah, Jim Dethmer, he would previously go to all of these companies and understand how their leadership worked. And it's a super readable book, super short, breaks it down in all of these chunks, depending on what you want to really focus on. He actually came and spoke to our company and it was really cool to learn from him about this. He doesn't do it much anymore. So, we felt very special to, to be able to have him. And It can act in all areas of your life. So it's not necessarily just leadership . It really extrapolates out to relationships, whether it be a romantic one, or not, or kind of a family one. It is really I think changed my outlook on a lot of things in life. So I think I would want to teach something that has to do with that, that book. Jim's wife actually does a lot of the Enneagram work too. So the Enneagram test and understanding really your, kind of, why you're wired the way you are almost. Everyone has this conception of life. And you get to learn more about the way people think and how they work and why they do the things they do. So everyone did that test, the Enneagram test, in our company, and you can start to see these patterns and things. And it's just very useful information and it just makes everyone, I think, work together and flow together a little bit better too, which is awesome. [00:32:25] Lindsey Dinneen: Yeah. It sounds like a great masterclass and I have it written down. I'm going to, I'm going to look it up right after so I can secure my copy. Yeah. So, and then how do you wish to be remembered after you leave this world? . [00:32:39] Hannah Went: Oh, how do I wish to be remembered? Hopefully as someone who is loving and fun and taught the world something. Doesn't necessarily have to be epigenetics related, but I think people probably see me right now as someone who is like very busy running around all of the time, going from place to place, and I don't think I like that. That's just what I think my interpretation of me maybe would be from the outside. But it doesn't feel like I'm busy, right? It feels like I'm doing the things that I want to do right now and I don't think I necessarily even like the word busy, right? What does that mean? Everyone's busy. Everyone's doing something to a degree. So, yeah, I just want to be remembered as fun, loving you know, I think would also be remembered, though, just as hardworking, determined and yeah, willing to work hard to reach specific goals. [00:33:32] Lindsey Dinneen: I love that. Yeah. And then final question. What is one thing that makes you smile every time you see or think about it? [00:33:41] Hannah Went: Just my family, my husband, my sisters, my mom, my stepdad, everyone. So I get to hang out with them next weekend. I'm super, super excited. We'll be with them at their lake house. So I'm excited to be with the family. [00:33:55] Lindsey Dinneen: Nice. Oh yeah. That's going to be wonderful. Well, Hannah, this has been such a great conversation and I so appreciate your spending some time with me today and sharing about your incredible journey and everything that's coming up too. And I'm so excited for you and for this mission and to see the company continue to grow and expand, so I do really appreciate you. being here. And we are so honored to be making a donation on your behalf as a thank you for your time today to the Equal Justice Initiative, which provides legal representation to prisoners who may have been wrongly convicted of crimes, poor prisoners without effective representation, and others who may have been denied a fair trial. So thank you for choosing that organization to support and we just wish you the most continued success as you work to change lives for a better world. [00:34:49] Hannah Went: Awesome. Thank you, Lindsey. I appreciate your time. [00:34:51] Lindsey Dinneen: Absolutely, you too. And thank you also to our listeners for tuning in and if you're feeling as inspired as I am right now, I would love it if you would share this episode with a colleague or two and we will catch you next time. [00:35:06] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Ruba Sarris Sawaya is a distinguished medtech executive with over 20 years of experience. Ruba discusses her journey from pre-med research to leading roles in market access strategy and consulting for medical device companies. She emphasizes the importance of curiosity, lifelong learning, and strategic thinking in her career. Ruba shares insights on women's empowerment in a male-dominated industry and the significance of broadening skillsets beyond assigned roles. Guest links: www.MediStrat360.com | www.rizlabhealth.com  Charity supported: Save the Children Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 040 - Ruba Sarris Sawaya [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Welcome back to another episode of The Leading Difference podcast. I'm your host Lindsey, and I am so excited to introduce you to my guest today, Ruba Sarris Sawaya. Ruba is a medtech executive who has been passionately committed to the medtech industry over the last 20 years. She is a leader with a reputation for cultivating loyal, engaged, and collaborative teams and who carries a visionary mindset with the ability to conceptualize and execute effective strategies that have contributed to transformative growth and innovation in the medtech space. She is currently leading market access strategy for RizLab Health portable diagnostics devices, enabling access for patients with the greatest healthcare disparities. Concurrently, she is the managing partner for MediStrat360, medical device consulting firm with a mission to accelerate the journey from concept to market for groundbreaking medical devices. Her educational background includes a bachelor of arts from Austin College with a major in biology and a double minor in chemistry and physics, a master's in public health in epidemiology from the University of Texas Health Science Center, in addition to her acceptance and completion of the leadership studies program at the highly competitive Posey Leadership Institute. Ruba brings a wealth of corporate strategy expertise, and a track record enabling successful device commercialization and market access. All right. Welcome to the show, Ruba. I'm so excited to talk with you today. [00:02:16] Ruba Sarris Sawaya: Thank you very much, Lindsey. I'm excited to be here. I appreciated the invite. [00:02:19] Lindsey Dinneen: Sure. Oh, absolutely. I'm so glad we got connected. So I was wondering if you could start by telling us just a little bit about yourself and your background and maybe what led you to medtech. [00:02:32] Ruba Sarris Sawaya: So, I mean, I've spent the last 20 years working explicitly and specifically focused on medtech, dedicated to commercialization of really cool technologies that have a profound impact on patients' lives. And I'm grateful for the opportunity this career gave me to work on some really disruptive technologies and collaborate with some brilliant minds across the industry. I had a front row seat to seeing how the incredible impact to the medtech industry can have on transforming healthcare. So what brought me into it, I initially wanted to go to med school, like a lot of people. I covered all of the basics and then graduated. And then, I was doing preclinical research at UT Southwestern Medical Center. And I completed all the requirements for pre med the summer before, took the MCATs, did all of it. The summer before I was supposed to start, decided I had a soft heart and that may not be the best decision. And so there was a moment there of, I'm going to start with research and kind of see where I go. And ended up working with a lot of reps and connected with a lot of people within the medical device industry. So I started looking for jobs 'cause it felt like the perfect opportunity with the intent that the pre med thing was this sincerely and authentically with a focus on wanting to help patients, right? And the beautiful opportunity med device provided me is that it enabled me to do that without the risks and consequences tied to direct patient care. That soft empathy piece or the super empathy piece on mine wasn't at risk from that standpoint. So I was doing research at UT Southwestern in the physiology department, interacting and engaging from a folks working on trials perspective and then medical devices that were being used at that medical center and then started applying for jobs within medtech. Took one managing preclinical research way back when at Orthofix, transitioned and got promoted to running clinical affairs there, and then got promoted again and managed clinical affairs, government affairs, health economics outcomes, research and reimbursement for that organization. And that was a really long time ago and then moved into different career roles from there. But that's the story on that one. [00:04:52] Lindsey Dinneen: Oh, that's incredible. So, okay. So let's bring it up to present day, and you are doing some fractional work and I know that you have, I'm sure quite a full schedule just in looking at your LinkedIn profile. I could see that you're extremely active in many avenues and I just love to hear some of what you're up to these days. [00:05:13] Ruba Sarris Sawaya: So I'm currently leading market access strategy and advising for a diagnostics company called RizLab Health, and they have a portable hemo analyzer that's really focused on enabling access for patients with the greatest healthcare disparities, which is really cool. I'm the managing partner for MediStrat360, so it's a consulting firm hyper focused on just medical device and accelerating that journey from concept to market for disruptive groundbreaking medical devices. So those are the two things that I'm currently focused on, and then I have some senior advising positions for quality regulatory and clinical for a couple of additional companies, one that's focused on sleep apnea devices. And that one's under an NDA. And then another diagnostics company. So I've got four fractional-- with RizLabs is to focus on device commercialization, go to market strategy. And then the focus for some of the other ones very much centered around regulatory clinical quality. [00:06:13] Lindsey Dinneen: Okay. Yeah. So, so with that you mentioned that you were doing this preclinical research and decided to switch gears a little bit. And now you've got such a, an amazing breadth of skill sets and experience and expertise. And I'm kind of wondering, within medtech, what was the journey like to learning, all these different aspects that now you are such an expert in. For example, say regulatory. [00:06:43] Ruba Sarris Sawaya: I think for me, because you don't see that often, you see a lot of folks that start in one specific area with respect to medtech, and they develop a pretty comprehensive depth in that area over the span of 20 years. I would argue that I've had an extraordinary career and that has not been my journey. And that has not been my journey mainly because I took roles within companies that were either smaller or midsize, and there was always a willingness to proactively volunteer, not even volunteer, but proactively volunteer, raise my hand when people left or when certain gaps existed that needed to be filled, and then proactively choosing to look at issues that were going on within an organization more holistically outside of my department. So just because my roles and responsibilities said I covered clinical didn't change the fact that I paid attention to a dynamic that said, there are reimbursement challenges that are happening. One, we were getting coverage and pushback from an insurance company tied to certain devices, engaging with an industry coalition to try and get some of those policies overturned, and recognizing that the information that I gained as a result of that experience identified certain gaps for the evidence portfolio for clinical affairs. So how did that happen? I think that happened because I had a habit of, I'm choosing to pay attention to what the organization needed and choosing to see the links for the existing roles and responsibilities that I had, and how they bridged across the organization. And then being proactive, quite frankly, about when I was really dedicated to every company I worked for and readily dedicated to the mission that they had and choosing to take roles that I may not have been ready for or may not have had full core competencies for in an effort to support that organization. So in a lot of cases I took it on and I was, I became an obsession and I learned everything I could and I addressed certain gaps by bringing in additional expertise with the intent that we still got the organization's mission accomplished in spite of the deficiencies or gaps or turnover that was going on. [00:08:59] Lindsey Dinneen: Wow. Yeah, that's incredible. I love that. You have been so curious and eager to learn and willing to step outside your roles and responsibilities and seek to understand what the organization needs. I'm sure that really helps now with your consulting work, because you're probably way better able to, and equipped to, find those gaps that you mentioned in a company's strategy or whatnot. And so I, what a strength to be able to bring that breadth of knowledge. [00:09:34] Ruba Sarris Sawaya: It's interesting when clients approach me about a dynamic that says, "We have this challenge." It is a prism where that challenge ties to different additional facets of the organization or facets of their market commercialization strategy. So we end up providing value and feedback that's not only solving the problem they came to us with, but providing recommendations that have an impact across different facets within that organization or within that product commercialization strategy. And I'm telling you it's, it is, that is one, I would argue, differentiating value prop that I bring to the table on the consulting side is offering that feedback where it's not it's not one sided. It's got depth to it and it touches different dimensions because we're not looking at it just within the scope of the problem as it's presented. [00:10:23] Lindsey Dinneen: Yeah, absolutely. That's awesome. That's great. That's something very unique to be able to offer. And so, you know, that curiosity and growth mindset, willingness to fill in the gaps and figure out how to, where did that come from? Have you always been a very sort of curious, eager to learn, lifelong learner type individual, or is that something you developed over time? [00:10:50] Ruba Sarris Sawaya: Both, I'll say both. The lifelong learner piece, definitely a part of my personality my whole life, one. Two, I will also say I was lucky in having some phenomenal mentors and strategic leaders that drove that value and the importance of that value, and enforcing us to see the bigger picture and think more holistically. And so I started out with that as part of who I am. And then on top of that, it was further reinforced by having some fantastic leaders that I was lucky enough to work with and for that emphasized the importance of that. [00:11:24] Lindsey Dinneen: Yeah. Yeah. And, you've mentioned having some amazing leaders that were in positions to really help mentor and guide and lead. And I'm wondering, what are some of the most impactful pieces of advice that you've received from leaders that you look up to and or now as accomplished leader yourself, what do you see as being some of the best pieces of leadership advice? [00:11:54] Ruba Sarris Sawaya: So I'm gonna I'm gonna share with you some of my favorites on what makes a good leader and things to pay attention to as a good leader. So to me, anybody who's trying to explore a leadership role within medtech-- it's to everything we just talked about-- it's unbelievably important to choose to see beyond the expected. So have a deep understanding. If you're a project manager for R&D and you want to get promoted to, you want to move up the ladder, you having a deep understanding of the technical aspects of medical device is important, but it's just as important to cultivate a deep understanding of not only the technical, but the technical and business aspects. So the willingness to learn beyond the scope that you are assigned to, the willingness to recognize the importance of strategic thinking, is really important from a leadership standpoint. Additional aspects that are important with respect to strategic thinking, don't be afraid to voice ideas, but be strategic about how and when you do that. So navigating a leadership role to me really requires developing a good acumen on knowing when to assert your ideas and when to hold back, learning how to read different situations and understand the dynamics at play. I think some of the most important advice I was ever given was that we all, especially when you join a new organization, we all have a proclivity for wanting to prove our value or demonstrate our value as soon as possible. And some of the best advice I've given that I've passed along is to be strategic, is to be really good about proactively recognizing when it's a good opportunity for you to do that. And when you're better off holding back and listening and observing and understanding the dynamics of play and choosing your moments wisely on when you make impactful contributions, right? Doing that, you maximize the effectiveness of the input you provide and the influence that you end up having and sometimes holding back initially, choosing to observe and listen gives you insights that better inform your strategy for what to do or how to do it. Building a network is also really important. That's another really good piece of leadership advice. We tend to keep our head down. Early on in my career, I definitely did that. I treat networking and the relationship management as a mandatory part of the job with roles I've had where I'm within an organization and outside of that. So I think that part is unbelievably important for leadership and success. And it's not just the creating a network offers job opportunities. It's creating a network offers opportunities to seek advice and to learn and to stay plugged in from an industry standpoint. So continuous learning is about being proactive and seeking those opportunities to challenge my current thinking, quite frankly, and expand my horizons from that standpoint. [00:14:57] Lindsey Dinneen: Yeah. Oh my goodness. That was so much great advice. Thank you for sharing all of that. I think even the first thing you said, I really appreciated about, see beyond the expected. And I think that's such, I have never heard it put quite like that before, and I really like that of your willingness to go beyond your scope, so that you keep learning and I like your idea of continuing to even challenge your own beliefs and thoughts and processes. All those things. If you can keep doing that, then you're growing, you're learning, you can't stay stagnant that way. So yeah, I appreciate that advice a lot. [00:15:38] Ruba Sarris Sawaya: One, to be clear, it comes from tons of mistakes made and lessons learned over a couple of decades for starting out in a technical role and a technical career. Those are common mistakes I see made, which is you're presenting to management on a project update, and the tendency for us technical folks, for people that started their careers out in science, is to very much focus on the technical aspects of what are going on without taking into account how that information is being presented, the impact that it's having on the politics and the different players in the room and their intent. So it's choosing to see things in a different light than the way that you're used to processing them is very important. Strategic thinking. It's different. [00:16:27] Lindsey Dinneen: Yeah, absolutely. And being willing, like you said, to look beyond and to approach things in a different way and maybe take a step back sometimes. Say, "Okay, I need to keep observing before I dive in with my solutions." [00:16:43] Ruba Sarris Sawaya: Well, and take stretch rules. I think that's the other thing from a career development. Nobody owns your career. You own that. And If you love medtech, if you love whatever your profession may be, if your goal is advancement and leadership positions within that, but then that profession or that role, it's recognizing that you have to learn other things beyond just R&D if your goal is to manage a division or manage a sector . So I think, it's saying you're going to fulfill your roles and responsibilities and focus on accomplishing those goals, but be selfish about raising your hand for stretch opportunities that provide you exposure to other areas and dimensions of medtech that are outside of your scope, right? With the intent that you're getting that exposure is unbelievably important. [00:17:32] Lindsey Dinneen: Yeah. Yes, I could not agree more. One thing that I noticed from just looking at your LinkedIn profile is you are very passionate about a lot of issues facing our society, our community. And, I saw some speaking opportunities and things where you focus on women's empowerment and whatnot. And I was wondering if you might share a little bit about your passions outside of work that do speak to it. So even with women's empowerment, encouraging women in the medtech field and whatnot, because we have listeners who might really appreciate some of your perspective and advice on that. Would you be willing to share? [00:18:14] Ruba Sarris Sawaya: Yeah, I mean, absolutely. Let's be very frank and transparent. I'm a woman that's been predominantly working in a male industry, and I've had some wonderful experiences, but I've also been granted some wonderful obstacles that tested my resilience and determination. I learned over time to see those challenges as an opportunity to strengthen my resolve and even my commitment. And so to me, a few pieces of advice to empower women as they navigate their own paths in leadership is to embrace your unique perspective. I think as women, we bring diverse experiences and insights to the table. And we should never underestimate the value of that viewpoint that we bring as women, right? Early in my career, and I've run into a lot of women that feel this pressure, to posture, to present themselves with a set of characteristics that are more akin to male dominated characteristics versus owning their executive presence, and recognizing the value they bring in authenticity for presenting who they are authentically and not underestimating the value of their own viewpoint versus others complying with the mass or succumbing to the pressure. So I think it's unbelievably important to honor and respect and embrace that unique perspective that you bring as a woman, trusting your instincts and not being afraid to voice your ideas. But again, unbelievably important to be strategic about when you choose to do that. And that piece of advice applies across both. And I think women have a tendency to coming into, especially high level, higher level management roles, a desire to want to prove our worth and prove we have a seat at the table. You have earned the right to sit at that table by default of the fact that you have been offered the job and you have it. Be smart, strategic about when and how you choose to weigh in, recognizing the politics at that same table, right? Is important. And then advocating for yourself and others to the point that you made about, I do quite a bit of speaking. I am on a mission to drive transformative technologies within healthcare. I'm also on a secondary mission to enable an increase in the number of extraordinary women and their commitment to that mission, right? So advocacy, empowerment, education, training on communications and engagement for women is a focus and how I choose to spend my time with the intent that I sincerely believe the more women that you have, more women and more diversity, quite frankly, that you can have in medtech, the better devices and the higher the impact that you can have with respect to innovation in medtech and an impact that MedTech can have on healthcare. So to me, that is a focus. [00:21:10] Lindsey Dinneen: Yeah. Well, and I very much appreciate your perspective and your willingness to share about it. And the fact that this is a mission for you. So, thank you for continuing to support and elevate women in medtech, 'cause it's a need. And to your point, I appreciate you saying that women bring a unique perspective. And so that can be your superpower and you don't need to shrink. [00:21:37] Ruba Sarris Sawaya: 100 percent and authenticity, Lindsey. I think women bring a unique perspective and value the power of authenticity. Resist the urge to position or posture or present yourself as "A" because you believe that "A" is what they want to see. There is unbelievable power in an executive presence of a woman leader that is authentic in the way she presents herself. [00:22:07] Lindsey Dinneen: Yes, could not agree more. Yeah, so, your career has been so interesting and I love the running theme of you being willing to continue to learn and grow and step out of the current role so that you can fill in the gaps. And I'm wondering if there are any moments that stand out to you where it just made you go, "Wow, I am really in the right place, at the right time, in the right industry." [00:22:36] Ruba Sarris Sawaya: So there's been a few of those, but I think one of the most memorable was when-- I have had a few leadership roles within Medtronic, and there's an annual event that gets held there where patients will are willing to share their stories with company employees. And listening to those stories, you realize what a difference we were making to the daily lives of those individuals. It was unbelievably moving and it gives you a renewed sense of hope. So we all in that office, especially, it's an extraordinary group of people that are working unbelievably hard and all of us were running at 90 and it's a constant hurricane of work, right? You lose sight. of how those hundred little activities we do every day are contributing in a transformational way to the lives of others. And sitting through that two hour testimonial set with those patients was a really emotional experience that kind of puts everything in perspective. That was a good what seven years plus now since I sat through that and it still resonates with me. I still think about it all the time. [00:23:47] Lindsey Dinneen: Yeah. Yeah, I think that's really powerful too, to have those moments of realizing the impact that you're making and it is easy to get caught up in the daily grind. And, and forget that, oh my goodness is actually, this impacts somebody's life. [00:24:05] Ruba Sarris Sawaya: It brings it to focus, Lindsey. I loved that whole experience because, and I'm telling you, on the days when getting up in the morning is a little harder than others, it's a nice reminder to just force myself to recalibrate against that. And that we tolerate the craziness, we tolerate the difficulties, we tolerate the barriers and the more difficult days because we have an impact on the back end of the lives of other human beings. And that's the reason I've stayed in medtech for the last 20. There's something extraordinary about that. The ability to do that for someone else is amazing. [00:24:41] Lindsey Dinneen: Yeah, it's a gift and it's something to come back to when the days are hard and long and frustrating, because you really do know what you're doing matters. Yeah. [00:24:52] Ruba Sarris Sawaya: Exactly right. [00:24:53] Lindsey Dinneen: Yeah. Absolutely. Well, pivoting the conversation just for fun, imagine that you were to be offered a million dollars to teach a masterclass on anything you want. It could be in your industry, but it doesn't have to be related to it. What would you choose to teach and why? [00:25:15] Ruba Sarris Sawaya: Honestly, I would teach exactly what I'm, a lot of the time I'm teaching now, which is device commercialization. And, to your earlier question about give me a couple of things that inspired you and told you were right where you needed to be, I taught a course at University of New Mexico, their innovation center a few weeks ago. And one of the nicest comments I've ever gotten from a career perspective is somebody came up to me afterwards and said, "I've been working with folks for a decade plus, and this is the first time in my life I have gotten such a good training that I walked out having a solid understanding of how these pieces tie together from a regulatory perspective and commercialization perspective." So what would I teach exactly what I'm what a lot of the time I'm teaching now from a consulting perspective, which is device commercialization. I picked a career that, that I'm lit up by and that I'm inspired by. I'd be doing the exact same thing, Lindsey. I wouldn't change a thing. [00:26:13] Lindsey Dinneen: I love that. That's so great. [00:26:16] Ruba Sarris Sawaya: Yeah. [00:26:18] Lindsey Dinneen: That's very special. I love that. Yeah. Okay. And then how do you wish to be remembered after you leave this world? [00:26:26] Ruba Sarris Sawaya: That I do quite a bit of mentoring. That I had an impact, that I inspired a group of people to maintain this mission to transforming healthcare. It's not just putting out and launching additional devices. It's sincerely a focus on looking at the areas across our healthcare system here in the U. S. and otherwise, and looking for opportunities to change the dynamic in a positive way. So after I die, what I want to be remembered for that the folks that I have, and I've taken on quite a bit over 20 years that I've tried to help grow and advance career wise that I inspired them to keep doing this. And I inspired them to do it well, and do it with integrity and do it right. [00:27:16] Lindsey Dinneen: I love that. Yeah, absolutely. And then final question, what is one thing that makes you smile every time you see or think about it? [00:27:27] Ruba Sarris Sawaya: I mean, personal, probably my cat. We have a British short hair that has an insanely cute face and it's impossible-- I don't care how stressful of a day I've had-- impossible not to crack a smile thinking about that fluff ball. So yeah, our cat for sure. [00:27:46] Lindsey Dinneen: Oh my word, I love that. Animals are the best. [00:27:49] Ruba Sarris Sawaya: Yes, well, and she's a recent addition. So we've had her a year. And it is definitely the stress buster. [00:27:57] Lindsey Dinneen: That's perfect. [00:27:59] Ruba Sarris Sawaya: For sure. [00:28:00] Lindsey Dinneen: That's perfect. Animals are inherently just happiness. Well, this has been an incredible conversation. I am so thankful for your willingness to share about your background and what you're up to now, but especially all of your advice. It was so packed full of just amazing pieces of advice to take away. And I really appreciate that you're willing to share all of that with us. So, gosh, thank you so much for your time and thank you for being here and and doing that. I really appreciate it. [00:28:33] Ruba Sarris Sawaya: Well, and likewise, thank you for doing this again. I'm a huge advocate for getting more folks and more people and more women and more individuals involved in medtech, and recognizing the phenomenal opportunities that medtech brings from a career standpoint. And so thank you for doing this because you're spreading that message and educating people on other career options besides, you know, firefighter, doctor, lawyer, engineer. So we appreciate what you're doing too, Lindsey, this is great. [00:29:03] Lindsey Dinneen: Thank you. That made my day [00:29:05] Ruba Sarris Sawaya: It's important. We got to spread the message. [00:29:09] Lindsey Dinneen: it's very true. It's very true. And we are so honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational, and safe environment. So thank you so much for choosing that charity to support, and we just wish you the most continued success as you work to change lives for a better world. And thank you also to our listeners for tuning in and if you're feeling as inspired as I am right now, I would love it if you would share this episode with a colleague or two, and we will catch you next time. [00:29:55] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Translating “engineer-speak” into marketing messages can get tricky when marketers don't have the depth of knowledge around the technical aspects of the project. Lindsey Dinneen, a fractional CMO and former brand engagement manager at Velentium, joins our hosts Michael Roberts and Ashley Hohensee to discuss how marketers can work with engineers and expand their own knowledge to craft the right message for the right audience. Hosted on Acast. See acast.com/privacy for more information.

Harout Markarian, founder and CEO of MARKBOTIX, shares his journey from Lebanon to the US, transitioning from a professional basketball player to a skilled roboticist. He discusses his educational background in mechanical engineering, robotics, and business, leading to the creation of MARKBOTIX. The company develops GRACE, an assistive robot for the elderly and disabled, aiming to reduce falls and improve quality of life. Harout's passion for engineering and helping people drives his mission to enhance independent living and accessibility. Guest links: https://www.linkedin.com/in/haroutmarkarian/ | https://www.markbotix.com/ Charity supported: Save the Children Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 039 - Harout Markarian [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and I am so excited to introduce to you as my guest today, Harout Markarian. Harout is the founder and CEO of MARKBOTIX, an innovative assistive robotics startup focused on transforming care for the elderly and individuals with disabilities. Harout, a skilled roboticist with multiple patents, holds a bachelor's degree in mechanical engineering, a master's in robotics, and an MBA. His professional path has been marked by significant leadership roles in engineering at top firms, including the Boeing company, where he designed the air refueling flight controls algorithm for the Boeing C 17. At MARKBOTIX, Harout's team is developing GRACE, Ground Robotic Assistant for Care Enablement, robot designed to reduce risks of falls, hospital readmission rates, and caregiver burnout, while providing support for everyday tasks. Under his leadership, MARKBOTIX has garnered significant interest, including over a hundred letters of intent from various facilities and is currently involved in beta testing with organizations like the VA Hospital. Harout is also a published author and speaker, advocating for the right use of robotics to improve independent living and accessibility through his book, "Mobility and Inclusion." His work extends beyond business as he actively contributes to the community, particularly through support for organizations aiding the elderly and individuals with mobility challenges. All right. Well, welcome Harout. Thank you so much for being here today. I'm so excited to talk with you. [00:02:23] Harout Markarian: Likewise. [00:02:24] Lindsey Dinneen: Excellent. Well, I wondered if you wouldn't mind starting off by just telling us a little bit about who you are and a little bit about your background and maybe how you got into medtech. [00:02:36] Harout Markarian: Sure. So I, I am an immigrant from Lebanon, a former professional basketball player, danced ballet for a little bit, and at one point ,my parents decided to immigrate to the United States. Needless to say that my academic career was a tremendously suffering when I was busy with the basketballs and the ballet dances of the world. So, so when they decided to immigrate to the United States. States. I was strongly against it, but deep down I knew that my parents always did things for the benefit of me and my sister. So, unwillingly I followed them. I came to the United States in 2008. I was 23, about to be 24 years old. And at that time, basically everything that I knew disappeared from my life. Everything that was normal to me disappeared. So I had to do something. I had no money. My parents didn't come with money. So I had to support, I had to help, so I worked full time as a waiter and I was also going to school full time to continue my undergrad in mechanical engineering. Mind you that I already completed three years of engineering back in Lebanon. When I got here, they said, "Oh the institution that you attended is not accredited." And my luck, I guess the institution got accredited a year after I left. [00:04:02] Lindsey Dinneen: Oh, no. [00:04:05] Harout Markarian: But it was a blessing in disguise. As I said, I wasn't the best student at the time. So the grades were reflective of that too. So, now that everything is no, no more distractions were in my life, I focused on my studies, finished three years of undergrad in mechanical engineering in a year and a half. My GPA went from 1. 8 to 3. 5 by the time I graduated. And during my final year when I was developing the senior design with my team, I experienced a tremendous shift in my life because I was part of this project where we built a six foot tall, fully autonomous robot. And we won the first place internationally in the autonomous unmanned system vehicle international competition. And that was a really a shift in my career in the way I viewed engineering, I viewed education, because up until that point, it was just to satisfy my parents. I'm like, "Here you go. This is the paper you wanted. Get off my back." But ,but right after that, it was like, okay, I want to know more about this robotics world because I really enjoyed it and I'm very curious individual. So robotics has different disciplines, sub disciplines I should say. So there's a mechanical design team, there's the cognition vision team, there's the electrical team, there's a navigation team. So, and I wanted to learn it all and I got involved with everything. And I really enjoyed it. So I ended up pursuing my master's immediately right after I graduated my bachelor's degree. I pursued my master's in robotics, and I was the only one in my cohort or not just cohort, in that year, that opted out of the, the comprehensive exam and wanted to do a thesis dissertation. Because I really enjoyed it. For me, theory alone doesn't mean anything. I need to see it in application. And that's kind of how I pursued it. I was able to build a stair climbing wheelchair. And that's a scale prototype of a stair climbing wheelchair that I presented it to my thesis committee and I learned a lot. I learned a lot and I graduated, but mind you at this time, I'm already working, I'm five years into my, my career in aerospace and defense. So things are going well. Really nothing medtech or healthcare related in my life yet. Except for that stair climbing wheelchair. And, and the reason for that is because I had the opportunity to work with a severely paralyzed person on brain computer interface technology that allowed him to propel his wheelchair through his thoughts. And when I got signed up to this project, I said, "Oh, moving things with your thoughts. That's cool. Let's do it." So, but I was approaching it like so mindlessly, if you will, because I didn't understand the impact that could have on individuals, especially individuals with disabilities, individual with limited mobility and elderly and everything in between. So while we were testing this technology with this individual, it required some training, basically. It's like an electrode that attaches to your skull. So it's a helmet that you wear. And as you think thoughts, it transfers to electrical signals that moves, that propels the wheelchair, moves the motors, right? A very simplistic way of explanation, of course. And, I was trying to test it by myself. So wearing the helmet, trying to move this wheelchair one way or the other. And it was very difficult because it's not second nature to me. I don't, I'm not a wheelchair user. So I, that's not a thing in my mind, but for this individual who was a paraplegic, it was, that was his legs basically. So for him, it was very second nature, right? So, and he got on there and I put the helmet on, set up everything for him and he was driving his wheelchair like I drive my car. That, that, that's how second nature it was for him. And for a moment there, I felt like I was the one with the disability. I couldn't even move a freaking wheelchair with my, so that was a big lesson for me in terms of understanding how limited we can be in, in different aspects of our lives, right? So, at that point I was, that was the first time I realized when I saw how independence and accessibility, what it meant to that individual. That was the first time in my life I said that I want to start a robotics company to help people become more independent. So, so to, to make their environment more accessible for them and to o for the elderly, to have them age with dignity. And that was the purpose. But nothing happened. I just continued with my life, with my job in the aerospace and defense industry. And then sometime later I decided, okay, I think I have a decent background in the technical side of things. I don't know much about business. Let's go get an MBA. So, so, so I went back to school. I did MBA at Pepperdine University. And I loved it because Pepperdine, at least the cohort that I was in and the teacher that I had, everybody was industry professionals and had their PhDs in their respective fields. So it wasn't, I wasn't just learning theory. I was learning how to apply that theory to real world problems. And that's how I learned that. That's where I thrive, right. And once, once I graduated with my my master's degree from Pepperdine, I, next day I went and incorporated the company. Literally the next day I went there and I was like, "Okay, I'm going to incorporate the company." And that's how MARKBOTIX was born. I'm not a hundred percent medtech. I'm approaching medtech from a different angle, if you will. But part of that, when I incorporated the company, I didn't really know what products or service I was really gonna offer. I knew who I wanted to serve, who were the people with disabilities, elderly, people in home cares, assisted living facilities. But I didn't know how to best serve them and with what. So I took a year and a half of going around and talking to people, basically doing customer discovery. And part of that customer discovery session, I stumbled upon the Ground Robotic Assistant for Care Enablement, which we call GRACE now. And all that robot does it initially, at least all that it did, was to pick items up, retrieve items for individuals so they don't risk a fall and then now they're in back in hospital or they injured something. And we're talking about fragile people, right? So when they injure something, the repercussions from it is really could, it could be hefty basically. And as I kept on talking to people, I built this prototype that retrieves items initially, and I tested it with over 300 people, and the more I tested it, the more apparent the need was. People were actually helping me feature up. So, we started with item retrieval, it went to real time video and audio interaction, remote operability, and other stuff that were included in the robot that right now is in development mode. And that's brings me to today where we're raising our first round of funding to bring this to life. We have a bunch of letters of intents from assisted living facilities and somewhere along the way that the DOD got interested in it. We got in contact with the Veterans Hospital. So everybody seems very interested in working with us. So we're, so today we're raising our first round of funding to bring this to life. [00:11:59] Lindsey Dinneen: Oh my goodness. That's incredible. Well, there's so much to your story. I'm so excited to dive in deeper. But first of all, congratulations on your company and its success and the interest, and I'm so excited because I know you're going to be helping so many people and there's such a need for it. So kudos. [00:12:18] Harout Markarian: That's the goal. Yep. Thank you. [00:12:20] Lindsey Dinneen: Yeah. Yeah, absolutely. So, okay. So your story is so interesting and it has so many different twists and turns. And I'm kind of curious, especially knowing, you started off with basketball and ballet and you did your academics of course, but maybe that wasn't quite the focus, could eight year old you have ever pictured you now doing what you're doing? [00:12:44] Harout Markarian: No. So two things. So I knew I wanted to be an engineer, even though I didn't know what that meant at that time. Ever since I was young, I knew I wanted to be an engineer, but I can confidently tell you that I didn't know what that meant. I just, my dad was a mechanic body shop person. He was an entrepreneur. He has his own place. So I thought that was, that's what I was going to be doing if I studied engineering. So that was stupid I was. The other thing is that, no, I mean, my dad was also a professional basketball player. [00:13:15] Lindsey Dinneen: Okay. [00:13:15] Harout Markarian: So, so having those two in mind, eight year old me would never picture me being here today, let alone leaving the country, right? [00:13:23] Lindsey Dinneen: Yeah. So, do you still do anything with either basketball or ballet or has? [00:13:29] Harout Markarian: No, I don't actually want. So once I left both ballet or dancing in general and basketball, I just completely abandoned it. [00:13:40] Lindsey Dinneen: Ah, okay. Fair enough. Do you miss it? [00:13:43] Harout Markarian: No, I don't, because I mean, it was good while I did it and I did it for a long period, I mean, relatively long period of time. So I did dancing for about 10, 12 years. And basketball, I did it from 16 when I went to professional to 23 years, 23 years old. I mean, relatively short career. But for me, my biggest passion was basketball. Just seeing my dad play, and then me being in that world. It was the biggest passion, and when it was taken away from me, or however you want to look at it, or I gave it up. I didn't give it up. I didn't want to give it up. Even long after it was over, I didn't want to accept that was not part of my life anymore. I was passionless for a while. So, finding that robotics world where I'm interested in something again, was a big shift for me. [00:14:36] Lindsey Dinneen: Yeah. Yeah. That's a really big deal. And that is hard, but I feel like it speaks a lot also to your resilience and your willingness to, to change and to pivot, as much as that word is overused. But you know, the thing is you have such a growth mindset, clearly. I mean, you're such a lifelong learner, you've gone and done the things that you wanted to do, but those aren't easy things that you've decided to do and you've had such a robust career so far. I mean, I love the fact that I think you're such a great testament to the ability to keep learning and keep enhancing your skillsets and keep going even when it is frustrating or you feel like you've lost this crucial part of you, but you still are able to keep going and do something amazing with your life. I think that's... [00:15:24] Harout Markarian: Absolutely. [00:15:25] Lindsey Dinneen: ...courage. [00:15:26] Harout Markarian: I mean, I mean, you have to do that because the only constant in your life is change. So you either adapt or you just fall behind and become miserable. And everything bad that goes, that follows that, right? So, if you don't change, time is moving forward, so you're just falling behind. [00:15:43] Lindsey Dinneen: Yeah. Yeah, absolutely. You started off in your career working for others and you had a amazing experiences, it sounds like, with very well known companies and brands, and then you switched to starting your own business and I know you got your MBA and I'm sure that helps you feel more prepared, but I do feel like there's often this-- once you actually do it, how much you have to learn on the job, so to speak. So I would love if you wouldn't mind speaking about your entrepreneurial journey and how that has changed and grown over time. [00:16:15] Harout Markarian: Yeah, so, so I'll tell you that college education doesn't mean that you're going to be able to thrive in the business world, right? Whether it's a technical side of thing or the business side of things. Unless you dive in there and do it yourself, you're just going to be dumber than a bag of rocks. So, I'm sorry for the expression, but that's that's how it is. Basically what engineering taught me is how to figure things out. They didn't teach me to find a job and hit the road running with that job, right. So everywhere I went, every company I worked for, I had to restart from scratch, go into my baggage of tools that college education gave me and depending on these knowledges, just figure out how to do my current job today and how to learn more. Because what you learn in school is just a baseline thing. It's just nothing really. And nowadays you can learn anything and everything online. I would even argue that nowadays, unless you're a doctor or an engineer a lawyer, maybe you don't really have to go to school. Everything else can be learned online. And there's a lot of resources today that back 10, 15 years ago, we didn't have. So on the job learning is the most real thing anyone can ever think of. Pepperdine came really close because I did my actual business plan to the company that I'm building today, I did it at Pepperdine. So it was a benefit for me because I studied, I got my education at the same time I worked on my business, so that's why I liked it a lot. But don't think that you're going to go to college and you're going to take a job. And all employers know, by the way, all employers know that they're going to teach you a lot when they hire you, they're just hiring you based on, I don't know, your enthusiasm, the willingness to learn, willingness to be adaptable, your demeanor, your behavior. That's what they're hiring. And I'm a Director of Engineering right now at different companies. So I hire people all the time. So that I don't hire them. I don't expect them to know things. I expect them to know basic things, but I don't expect them to hit the ground running regardless of where they are in their career. [00:18:30] Lindsey Dinneen: Sure. Sure. So when you stepped into this, this entrepreneurial journey, and you're the owner of a company, you are the leader of this vision-- did you find that to be a relatively easy transition because of the past experiences that you'd had? Or was that element of stepping into this high leadership role, was that, yeah, difficult in any way? [00:18:56] Harout Markarian: In different things that I tried in my life, I felt like I was always adaptable. I was always willing to learn. And I never quit. I failed a lot, but I never quit. Right? So I feel like that definitely contributed to, to how I'm managing myself in this role. Is it easy? It's not easy at all. It's difficult. Whoever tells you starting a company, building a company is easy, it's out of their mind, especially in the beginning stages. Because having other people get on board and see your vision, it's the toughest challenge a founder can embark on. So if you overcome that, then you definitely have what it takes to lead a company. [00:19:44] Lindsey Dinneen: Agreed. Yeah. Yeah. And so are there any moments that stand out to you as you've started this company or even prior to that, where it just kind of confirmed to you, "Yes, I am in the right industry, at the right time for a purpose." Was there like a moment that you thought, "Wow, this is why I'm here." [00:20:05] Harout Markarian: Well, first and foremost, I pray to God every day. I asked God for his guidance. If it's not part of his plans, please give me a sign. So I just go do something else, right? And till now he didn't give me any sign to abandoning it, but or I'm that, I'm just that's too but that i'm not realizing it but no, that's that's my first go to right? I always embark on my day, on my journey, by asking God to guide me through it. Having said that, the countless numbers of interviews and research that I've done-- and this, mind you, this is not leveraged research-- this is me talking to people one on one. So over 1000 interviews over the past year and a half, or almost two years talking to people, it was reassuring to me that, okay, this is needed and I'm going to be helping a lot of people. And that's really what kept me on this journey. Just now I feel responsible for all the people I talked to. I have a responsibility to see this through. If I focus on the competitors, the market, the investment, the investor, then I would give up long time ago. Then that's not the right way because the market, the investor, the Investment, they didn't do the work I did in terms of talking to the end user and how it's going to benefit them. So they don't really know that, they don't understand that. So it's my job to, we talked about vision, it's my job to clarify the vision to the investor, in this case. So it sees that how many people is going to benefit from this. So that was the reassuring factor. Conducting that customer discovery was so important. Because that sets the expectations for myself and everyone I talk to. [00:21:58] Lindsey Dinneen: Yeah, absolutely. Thank you for sharing that. I think it's helpful, so helpful to have those moments, something to hold on to when it does get hard because it's inevitably going to get hard and frustrating and discouraging at times. So being able to go, "Oh, wow. But I know this is impacting people. And if I don't do it, will anybody else?" That's, but that's powerful to motivate you. [00:22:22] Harout Markarian: Yeah, and I mean, I want more people to do what I'm doing because the market supports it, right? Just, we're talking right now, a little left brain, right? Logic. The market supports it, there's gonna be more people older people. The elderly population is increasing, is going to get bigger. So there should be more companies like mine addressing the same need because one or two or three companies are not going to be able to close the gap. [00:22:50] Lindsey Dinneen: Yeah, absolutely. So what are you most looking forward to both perhaps personally and then professionally with your business? What is on the horizon that you're excited about? [00:23:02] Harout Markarian: Personally, I just want to enjoy my family, enjoy my wife, my kids, my parents before they're gone, because of everyone, everyone's going to leave at one point. So I would love to have some quality time with my parents, with my kids, with my wife. That's on the personal side. That's what's really meaningful to me. On the business side, I just want to add value to people. Hopefully this will be the vehicle, how I'd be able to do that. And as I said, I feel like I have the responsibility right now to see this through just because of all the conversations that I've had with people with different disabilities, with different challenges that this technology could help them overcome that. [00:23:45] Lindsey Dinneen: Yeah. Yeah. And it's exciting. You're in a really exciting growth phase too. So there's a lot to, a lot to be joyful about, I suppose. [00:23:54] Harout Markarian: Yeah. [00:23:55] Lindsey Dinneen: Yeah, that's amazing. Well, pivoting the conversation just for fun, imagine that you were to be offered a million dollars to teach a masterclass on anything you want. It could be in your industry, but it doesn't have to be. What would you choose to teach and why? [00:24:12] Harout Markarian: For them to be connected with God more because I feel like, and I don't know if I'm the right person to teach that, right? But because everything else doesn't matter. Everything else is temporary. I think the divine is, is the only thing that is not temporary. Your spirit, your soul is the only thing that is not temporary. Your challenges, your difficulties, your tough times, your good times, your money, your lack of money, all of that is temporary. What's not temporary is your soul and spirit and what happens to it afterwards. So, a lot of people today are behind social media and the fakeness of the world. And that's what I want to separate myself from, and see if I had the opportunity, I would just teach people to be more authentic and more connected to God. [00:24:59] Lindsey Dinneen: Yeah, absolutely. And then how do you wish to be remembered after you leave this world? [00:25:05] Harout Markarian: I don't know if I want to be remembered, but if I do good to people, if I serve people in this world, in my time here hopefully I'll I please my God. And that's what's important to me, because pleasing God is serving others. So that's what it means to me. If I do that, then hopefully I'm pleasing God and helping people in the way. That's my thing. I don't know what being remembered means really who's remembering me, right? That's the question that I always ask and I wasn't always I didn't always think this way. I didn't always think this way. I always said to myself, okay, I want to be remembered like this great athlete, for example, right, when I played basketball. Or I want to be remembered like the person who founded the biggest assisted robotics company in the world. All that doesn't mean anything, because all that is material stuff, in my humble opinion. And I'm not saying I'm right, right? This is how I think. As, as long as I'm serving others, I'm helping others, hopefully doing it in a gracious way, that's what I'm looking for. [00:26:04] Lindsey Dinneen: Yeah. Yeah. Well, I think that's incredible and that's, I frankly wish that more people felt that way. So I think that's a, I [00:26:15] Harout Markarian: Well, I, it's a hard thing to do and I'm not saying I'm doing it perfectly. Sometimes we have a lot of distractions. That's not the norm So if we follow what's around us, then we're not going to think that way and I struggle with it too. So I constantly strive to keep myself true to what I just said right now. [00:26:32] Lindsey Dinneen: Yeah. Yep. There you go. And then, final question, what is one thing that makes you smile every time you see or think about it? [00:26:42] Harout Markarian: Oh, my kids. My son is five, my daughter is two ,and they're hilarious, even when they're a pain in my ass, so. So, sometimes the things they say is, and then, I like to also I'm a light guy. I like to think that I'm a light guy, so everything is a joke to me. I don't take a lot of things seriously. So I'm always giving people hard time kind of in a humorous way. So I like to pick on my wife, pick on my sisters. So these kinds of things make me smile. Sometimes it's stupid. Sometimes it's makes others smile to you, but it's just light stuff. I just enjoy my life, enjoy the time I have with the people I love the most. [00:27:20] Lindsey Dinneen: I love that. That's fantastic. Yeah, well, first of all, again, thank you so much for sharing your story and your insights. And, it's so interesting to me how you have had such resilience and a growth mindset and now discovered this sense of humor as well. I mean, I'm sure that helped exponentially as you had to go through so many different iterations or stages or seasons, whatever you want to call it of your life. And some of them sounds quite difficult. So I just want to say thank you for sharing that story and thank you for talking about it and giving inspiration and hope to somebody else who might also be in maybe a transition period or something like that, where it might be a little harder. So I, anyway, just... thank you. [00:28:05] Harout Markarian: And I, I don't downplay the challenges, right? Of course I recognize them, but I just choose to take it lightly because as I said, nothing is permanent. Everything is temporary, so don't think too much about it. Just, pray and move along. [00:28:23] Lindsey Dinneen: That should be on a t shirt that you sell or something. [00:28:26] Harout Markarian: Yeah, that's a good idea. I might I'm that might be merchandise. I'll say I sell on MARKBOTIX's website. [00:28:32] Lindsey Dinneen: Please do. That's amazing. I love it. Oh my gosh. That's so fun. Well, this has been such a great conversation. I've enjoyed it so much and I'm very appreciative of you spending some time with me today and talking, and we are so honored to be making a donation on your behalf as a thank you for your time today. And that is to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational, and safe environment. So thank you for choosing that charity to support, and we just wish you continued success as you work to change lives for a better world. [00:29:11] Harout Markarian: Thank you so much. And thank you for your time as well, Lindsey. [00:29:14] Lindsey Dinneen: Of course. And thank you also to our listeners for tuning in. And if you're feeling as inspired as I am right now, I would love if you would share this episode with a colleague or two, and we will catch you next time. [00:29:25] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Ashley Mooneyham and Jennie Lynch are the co-founders of Momease. Ashley, a PhD-trained scientist and melanoma survivor, shares her journey from cancer biology research to developing an innovative breast pump solution inspired by her own motherhood challenges. Jennie, a serial nonprofit entrepreneur, discusses her transition to the MedTech industry and the importance of supporting new mothers. Together, they highlight their mission to create a pumping bra with warmth and massage, aiming to improve the breastfeeding experience for women. Their story is one of passion, innovation, and dedication to advancing women's health.   Guest links: https://www.momeasesolutions.com/ | www.linkedin.com/company/momeasesolutions/ | www.instagram.com/momease_solutions/ | https://www.facebook.com/MomeaseSolutionsInc/ Charity supported: Save the Children Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 038 - Ashley Mooneyham & Jennie Lynch [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and I am so excited to introduce you to my guests today. They are Ashley Mooneyham and Jennie Lynch. Ashley is the CEO and co founder of Momease with experience as a mother and as a PhD trained scientist to lead research and development. Jennie is the president and co founder of Momease. She is a serial entrepreneur in the nonprofit space with customer base experience leading operations. Well, thank you so much for being here, Ashley and Jennie. I'm so excited to speak with both of you today. [00:01:33] Ashley Mooneyham: Thank you. [00:01:34] Jennie Lynch: Yeah, thank you for having us. [00:01:35] Lindsey Dinneen: Yeah, absolutely. Well, I would love if you wouldn't mind starting off by sharing just a little bit about yourself, your background, and maybe what led you to MedTech. Ashley, do you want to start us off and we'll go from there?   [00:01:48] Ashley Mooneyham: Yeah, sure. So my background is in kind of your traditional laboratory research science. I did choose to pursue a PhD in cancer biology, and that was motivated both by my own personal experiences as a melanoma survivor, as well as, of course, knowing so many people who suffer from cancer and are impacted by cancer. I really wanted to make a difference there. And I very much intentionally chose a laboratory for my thesis work that focused on ovarian cancer research because I've always been really passionate about how scientific discovery can impact human health. And of course, as we're all aware, women's health kind of lags behind. So we need more women in science to be asking those questions and pursuing those answers when it comes to translating scientific discovery into impacting women clinical outcomes. And I really enjoyed my thesis work, but I felt far from making that clinical impact. I was doing the traditional bench work, working with mice in the basement of my university, and I just wanted to get a bit closer to the action. So after my PhD, I became a medical writer at Superior Medical Experts, which is a Minnesota small business focused on medical writing and research support. And I actually was quickly promoted to their Director of Grants, where I helped small businesses in the medical device industry pursue federal grant funding to de risk their medical innovation. So I got to learn a lot of varieties of discipline within scientific medical device and technology innovation, and got really excited at helping them secure funding to see their idea come to life. And I've actually worked with a few companies that since working with them have made it to clinical use of their innovative technology, which was super rewarding. Then in April 2021, I had my daughter, she's 3 years old now. And I kind of naively thought it would be easy to go back to work after that experience. But a huge pain point in my going back to work was. trying to maintain my breast milk supply for her via the breast pump. So that kind of leads into the origins of Momease solutions, but I'll save that for after Jennie gets a chance to introduce herself as well. [00:04:12] Lindsey Dinneen: Amazing. Thank you. Jennie? [00:04:15] Jennie Lynch: Yeah, so my background is I'm a serial non profit entrepreneur. So I founded two Minnesota based non profits focused on child development and family well being. So mostly doing the business operations and development for those two non profit organizations. The first one is Monarch Montessori School, a traditional children's house Montessori that's really rooted in the literature that supports best pedagogies for optimal child development, as well as Kaleidoscope Learning. That's my second non profit, which is a family community and resource center, just a one stop shop for families to be able to get all the best practices associated with raising their children ages birth to six years old. I frequently work with the population that is going to be Momease solutions' customer base. So I love working with mothers, women who are pregnant or newly postpartum and are going through the very wonderful, but very precarious kind of transition into motherhood. So that's kind of where my background is. I do not have a medtech background. But I'm somebody who's really passionate about looking at the literature when it's related to child development. So what is the optimal strategy in order to really nurture a person's early development related to cognitive, physical, social, emotional development. I originally got connected with Ashley through Mutual Business Connections and I instantly loved the idea. I saw how it would be used by the women who I currently work with and just really recognized that it was a really special product. So I officially joined the team in 2023. [00:06:05] Lindsey Dinneen: Wow. Nice. Well, congrats. How exciting. Yeah. So I love it. So would you mind telling us a little bit more about Momease and just maybe the origin story. [00:06:19] Ashley Mooneyham: So yeah. So like I said, I had my daughter in April of 2021. I was able to nurse her without issue for eight weeks during my maternity leave and I was so excited about that because the American Academy of Pediatrics, the World Health Organization, they all recommend exclusive breast milk nutrition through six months of age. To Jennie's point to try to promote the health of our next generation with cognitive ability and various health indications that research shows are improved with that breast milk nutrition. And I really wanted that for my daughter if I could achieve it. I was grateful to not have issues nursing, but when I went back to work, I thought kind of naively that I would be able to use the breast pump to continue to feed her breast milk, even though I was remote and away. And unfortunately, that was not the case, which is a super common issue with women. I had to pump three or four sessions to get one bottle for my daughter, so I was really working overtime, trying to do enough breast pump sessions to maintain my breast milk supply. And I was sitting at the breast pump for far too long, usually 20 to 30 minutes a session, increasing the suction power to a level that caused discomfort just in my attempt to provide my daughter with the nutrition I felt that she needed. And I was really frustrated by that because I knew, based on my successful nursing journey, that I did provide enough breast milk for her. I simply wasn't able to collect it. So the issue was with the collection mechanism. And with my background in science, I immediately sought answers. How can I improve this experience, just for me personally, on the onset. And I did find academic studies that showed if you apply a warm compress while using a breast pump, you get more milk in less time. If you use a hand massage technique while using a breast pump, you get more milk in less time. And anecdotally, that was true. If I applied a warm compress, if I put pressure on my breasts while using a suction based breast pump, it worked. And that made sense to me because a nursing infant is doing a lot more than sucking breast milk. They're also using the warmth of their mouths and the pressure of their jaw and hands in a combination to efficiently nurse. So adding these elements back in made perfect sense. The issue is it's not convenient. Using a breast pump is already not convenient and having all of these extra tasks while using a breast pump certainly wasn't convenient. So I literally went to Google and looked for a product that could warm and massage the breasts while I was using a breast pump in order to maintain these improved results. And I didn't find one. And I was really shocked by that. I was like, "How could this not exist when there is evidence that it works?" And I'm having personal anecdotal experience that it works. I was so disappointed. And I sat with that disappointment for a couple of months and then realized, "Well, it doesn't exist because people like me just sit disappointed." You kind of have to get up and get going to solve the problems, especially that you see personally. And the whole first year of business before we had a lot of funding in the door, I made sure to broadly collect women's experiences with the breast pump, and I learned really quickly that I was not alone. Our first customer discovery survey received 1, 200 responses in 24 hours, which is incredible and unexpected. I just put it out over my personal Facebook to start and it got picked up and got a lot of responses. And that alone, I think, really speaks to how passionate women are about wanting a solution and how desperate they are for wanting a solution. And every day that keeps Jennie and I going. Every day that we pitch this, every day that we talk about this, more and more women say how much this is needed and how much they're rooting for us. And that, that's our big motivation. [00:10:22] Lindsey Dinneen: Yeah. Wow. That is incredible. Thank you for sharing that story. And even the, I love the personal connection, but then the fact that just within 24 hours, like you said, of your own personal network, you've got this amazing response of all these women saying, "Yes, I am in the same boat or I've experienced this. Please help." I love that. So then Jennie, you're coming into this from your business development, business strategy background. And I'm wondering, how have you been able to to bring Momease along as it continues to grow and opportunities continue to come for it. And then what are you excited about as we go towards the future? [00:11:06] Jennie Lynch: Yeah. So that's a really good question. Momease is pre launch. So, I'm continuously just having conversations with mothers, continue to get that feedback, that customer discovery. Again, being pre launched most of my focus at the moment is long term business development strategies. So just thinking about those things ahead of time, but also just day to day operational things. I'm definitely excited as we move towards launch of the product. I think that I would love to see this product in people's hands. We're currently prototyping. So just seeing women use it, as well as getting their initial feedback is something I'm just very excited about. [00:11:46] Lindsey Dinneen: Amazing. So in this pre launch stage, I know you have a bazillion things going on, I'm sure, and there's lots to think about and a lot of exciting things happening, but what's the next step for you at this point? You have some funding, it sounds like, but now what's coming up, the very next thing? [00:12:08] Ashley Mooneyham: Yeah. So I don't know that we've said explicitly, but just in case anyone isn't aware, we are trying to create a pumping bra with built in warmth and massage. So that's the product that we're seeking to create. And we did receive funding last year from the National Institutes of Health to pursue this, which is really exciting. So the National Institute of Child Health and Human Development awarded us a Phase I grant to do the prototyping that we're currently underway with and achieve our proof of concept ahead of validating it and then launching the product. So right now we're definitely in that proof of concept prototyping phase. We have seen promising early results that we were hoping to see. And now it's a matter of kind of fine tuning the product at this early stage so that when it hits the market it's more than functional, it's convenient to use. We want this to be very clear that it is a product with integrity that was also designed by a mother for mothers, designed by women for women. I think that is something that this market is looking for, and women's products are booming right now. So I feel like this is right place, right time for us to enter and hit that inflection point. [00:13:25] Lindsey Dinneen: Absolutely. Well, congratulations on all of the success so far. I know it's not been an easy road. I'm sure there have been lots of late nights and stressful days, but you're doing it. So that's amazing. And thank you for bringing this to market because it's so needed. And I'm curious, is your goal to be able to provide this directly to consumers? Are you hoping to have an intermediary? What are your thoughts with that? Because I'm sure some people are so excited to go, "When is this going to be real?" [00:13:59] Ashley Mooneyham: That's such a good question. [00:14:00] Jennie Lynch: Yeah, absolutely. So we have two ways we would love to enter the market. The first one is traditional business to consumer channels, so sales directly through our website, maybe at brick and mortar stores, big box stores, boutiques, being listed on online retailer websites. Just the traditional ways you can get a consumer good into your hands. The second channel is more business to business. We would love to sell directly to NICU units. We have heard from NICU units or individuals who work in NICU units that this is something that would be really beneficial, as well as we would love to reach out to breast pump manufacturers who might be interested in bundling our product with their breast pumps to have that kit mothers can buy right away that will have a synergistic effect right from the get go. So those are two go to market strategies. [00:14:56] Lindsey Dinneen: Amazing. Well, that is very exciting. So as you've been going on this journey, and I'm sure you've had amazing days. I'm sure you've had some discouraging days. Are there any moments that stand out to you as really clarifying to you that you are in the right place at the right time doing what you are meant to do? [00:15:18] Ashley Mooneyham: Yeah, absolutely. I think one that I already mentioned was that first customer discovery survey. That's one of the first things I did after formally launching this business. And it's been a through line ever since. It's a touch point that we can constantly go back to that validates why we're doing what we're doing and that it's worth pursuing. And then shortly after that, I did start participating in pitch competitions where I was able to present this idea more widely. And the first competition that we ever entered was the HyVee Opportunity Summit, which was hosted at US Bank Stadium. And we were selected as, I think, a top nine finalist to pitch from over 900 applicants. And during that pitch contest, we took home grand prize. So out of the top nine, we got the number one prize slot. And I distinctly remember getting down from that stage so shocked that we were able to secure the grand prize our first pitch competition, but feeling so proud that what we're trying to do resonated and literally women came up to us with tears in their eyes. And I, it just, it was so buoying. It really felt like, "Oh, this is something that matters. It's something that is beyond a solution for just myself." But 97 percent of our survey responders said that they were dissatisfied with the breast pump. And that's such an incredible dissatisfaction rate for such an essential piece of technology. So those were two big wins for us early on. And then later last year when we were able to receive validation also from this huge federal scientific body that what we're doing is beyond like a feel good mission. It has scientific merit. It has significant potential to impact not only women's health, but human health by nourishing that next generation. That was a big win as well. And we're so excited for all of that collective experience to be really able to dig in this year to the research and development and start to make this idea a reality. [00:17:25] Lindsey Dinneen: Yeah, absolutely. And Jennie? [00:17:30] Jennie Lynch: Yeah, kind of echoing Ashley, she hit some of our big milestones in 2023. This year, I've had a couple friends and family members who've had little ones, and it's just been really interesting seeing a lot of my friends and how they're coming into motherhood. And how this product is something that they're probably not going to be using it for this child, but maybe in the future. And they're just really excited for us to be able to launch our product and for them to use it in the future. So that's something, just that verbal reassurance from our community is something that I think is what keeps us going. [00:18:08] Lindsey Dinneen: Yeah, of course, that makes so much sense, and I'm so glad you have that, so much social proof, the stories of the people who are coming up to you, and then you've also, like you said, have this tangible grant that really did help say, "Yeah, this is very important, this is very needed," and I'm sure those things really help on the difficult days, so I'm so glad you have all of that. But speaking of difficult days, I am wondering, in this journey, I'm sure there have been lots of ups and downs. What are some of the things that you have maybe been surprised about as you have gone about this new journey? And I know, Jennie, there's a lot of entrepreneurial endeavors in your background, but just in general, when you're getting into a new thing, there's always unexpected things that pop up. So just curious as anything come up for you yet? [00:19:02] Jennie Lynch: Something that I have found unexpected and slightly challenging at times, something that Ashley and I constantly are thinking about is, how we're kind of in this in between space where we're kind of known as a consumer good, yet we are a medical device, and it's been really hard to communicate some of the challenges related to being in that in between space with a lot of either investors or cheerleaders or people who are just interested in our product. We're more complicated than that average consumer good, yet we're not going to be put into the body. We're not as technical as maybe other medical devices that are on the market. So we really are in this in between space and there aren't too many players who are as well, at least that we've come across in our own journey. So that is a weird thing that we've run into is how do we effectively communicate where we are on the market and the importance of the product. [00:19:57] Lindsey Dinneen: Yeah. Yeah, absolutely. And Ashley? [00:20:01] Ashley Mooneyham: Yeah. Jennie hit the nail on the head that continues to be a thorn in our side, but we are getting better and better at navigating this middle ground and explaining that's actually our secret sauce in a lot of ways, that we're not a simple consumer good, and we're not a complicated medical device. We exist in this elegant in between to hopefully be that solution. And then I think just what a lot of founders can relate to, the only other major challenge is fundraising for the effort and being really careful with the funds that we have raised to make sure that we can go as far as possible and really time the spends strategically. So that's been something that we're constantly evaluating, making sure that we're using our funds responsibly and constantly have our eye on future fundraise efforts to make sure that there's no major gap in funding that could hinder our progress. And I will just say having a co founder like Jennie through this experience has made every challenge much more bearable. So, I'm so glad that we get to go through it together. The hard days are much easier having a co founder like Jennie by my side and the good days are even more fun to celebrate. [00:21:11] Lindsey Dinneen: Oh, I love that. So you both are absolute powerhouse women. I got to take a look at your LinkedIn profiles and I was just really admiring everything that you have done in your past, your education, your expertise, and then your commitment to community and the fact that you're still actively volunteering and you're doing all of these things. And it really struck me as not only incredibly impressive, but also I just have to ask, do you sleep? [00:21:42] Ashley Mooneyham: I mean, I have a two month old at home, so no. But I will say, that gives me extra waking hours in the day, so that's always good. I don't know how Jennie does it. [00:21:55] Jennie Lynch: Man, I think similar to Ashley, I do have a good support network and I think that makes all the difference. I don't think that I could achieve what I have without the friends and family who continue to uplift me. So that's what keeps me going too. [00:22:10] Lindsey Dinneen: Yeah. Yeah. Good reminder about the importance of community, absolutely. That's phenomenal. What is your top piece of advice you have for other women medtech founders specifically, or women medtech leaders. [00:22:27] Ashley Mooneyham: Yeah. I mean, it's something I constantly think about and learned through this journey is that being a woman founder is a strength. It's not a weakness. You don't need to justify being a woman founder. You don't need to justify pursuing a women's health problem with a women's health solution. I actually think all of that is a strength. And the second I stopped defending myself as a founder and defending my product and instead presented it as the opportunity it is and found like minded, passionate individuals like Jennie to join the journey, the more success we had. So I would just encourage all women founders, women entrepreneurs to remind yourself that you are doing something exceptionally valuable and your perspective is exceptionally valuable. And it's not something that you need to make excuses for or feel like you need to be on the back foot about. [00:23:24] Lindsey Dinneen: Yeah. Yeah. Jennie, do you have anything to add to that as well? [00:23:29] Jennie Lynch: Wow. Yeah, absolutely. The main takeaway that I have since starting entrepreneurship is create a community with people around you who will continue to support you. And mostly what I mean by that is Ashley and I have already established a community, both in Minnesota and nationally, that incorporates women health founders, and the amount of just brainstorming and good ideas that we get bouncing ideas off of one another is really wonderful. And it's great being able to connect with women who are in a similar position. [00:24:06] Lindsey Dinneen: Yeah, that's great advice. Thank you both. Yeah, so pivoting the conversation a little bit, just for fun. Imagine that you were to be offered a million dollars to teach a masterclass on anything you want. It could be in your industry, could be about what you're currently doing, but it doesn't have to be. What would you choose to teach and why? [00:24:27] Ashley Mooneyham: Well, I can give an industry specific answer right away if Jennie wants a couple more minutes to think. This might be the more boring answer, but Jennie leads an exciting life, so she can back end this with something more fun. But like I said, my expertise originally was in helping companies secure that non dilutive grant funding. Honestly, I want to spread that message more to small businesses, because I hear over and over again how much funding ends up being a barrier to small businesses, especially in the earliest stages of ideation and de risking whatever it is that they think matters and should be introduced to the market space. And that ends up stopping so many great ideas from getting a chance even to move forward in the market. So I am constantly working on this now without a million dollars, but if I had a million dollars I'd love to just be able to spread that message more, especially to the businesses that have that mission and heart behind them. So right now there's that White House initiative, as well as the National Institutes of Health Initiative to fund women's health research. Every female entrepreneur I meet in women's health, you can't get me to stop talking about federal grant funding and pursuing grant funding to really maintain ownership over your idea, ownership over that direction, which is going to be important for any founder, but particularly those that are trying to represent disadvantaged populations or underrepresented populations. You get to maintain your ownership and you get to de risk your idea so that you can move it forward. That's just where my mind goes to right away. [00:26:09] Lindsey Dinneen: Yeah, excellent. Very needed too, so. [00:26:13] Jennie Lynch: I guess if I had to teach a master class, I can come in with something a little bit more fun. So a couple years back, I spent a lot of time traveling. I was doing the digital nomad thing, so maybe a master class on all the ins and outs that come with how to work. And live on the road and you know how to organize your life a little bit to make that a little bit more streamlined. There was some trial and error for a couple years and I have this wealth of knowledge that's all living in my head, but it would be really cool to bring that to life in a master class, I think. [00:26:48] Lindsey Dinneen: Absolutely. Yes, as a digital nomad myself, I fully understand what you're talking about and getting, that learning curve can be a little steep sometimes accidentally you think, "Oh yeah, I'm prepared." [00:27:03] Jennie Lynch: Yeah, exactly. You never know what, what's going to come up when you're traveling around. [00:27:09] Lindsey Dinneen: I always say there's never a dull moment. And then, how do you wish to be remembered after you leave this world? [00:27:17] Ashley Mooneyham: Jennie, your turn to go first. [00:27:20] Jennie Lynch: Sure, I can go first. Yeah, well, I guess if there was something that I would love for, I would love to be known as a very loving person, a kind friend, somebody who's always positive, and gives everybody the benefit of the doubt. I guess a distinct characteristic that I would love to be remembered for is maybe what my partner calls "activator energy." I really love just immediately tackling a project, bringing something from zero to one. So if I had one characteristic, it would be that kind of activator energy characteristic. [00:27:56] Lindsey Dinneen: I love that. [00:27:58] Ashley Mooneyham: I do too. And that's a perfect answer. Yeah, I agree with Jennie. What matters most are those interpersonal relationships and connections that you have in close community with. Those are the things that matter most to me. It's way more important to be a good wife, good mother, good friend, good daughter in the time that we have. But also obviously, I'm hoping with Momease to leave a legacy that does make an impact in women's health one way or another. And I try to keep that in perspective with our business goals always that any win that we have is a win for women's health. Anything that we achieve is validation that funding women's health is worth it and that this field is worth pursuing. And I hope that it continues to improve after our journey ends with Momease, wherever that ending point is. And I hope that's a way that we can leave our thumbprint outside of our families with something a bit greater. [00:28:58] Lindsey Dinneen: Yeah. Yeah. Those are beautiful answers. Yeah, and then my final question. What is one thing that makes you smile every time you see or think about it? [00:29:11] Ashley Mooneyham: Well, my answer is easy. I have children, so that's obviously a joy in my life. And another thing that keeps me going every day, I want my kids to know that if they have an idea that you should bet on yourself and pursue it. And I hope that I can model that for them, even in an uncertain, scary landscape like entrepreneurship. So yeah, grateful for my kids. I have a daughter and a son. [00:29:38] Jennie Lynch: For me, it's just a nice cup of coffee, but immediate smile. [00:29:44] Lindsey Dinneen: I can relate to that, especially in the morning first thing when you're just like trying to get recombobulated and here we go. [00:29:52] Jennie Lynch: Absolutely. [00:29:53] Ashley Mooneyham: Yeah, that first cup isn't even a smile. It's just necessity. And then if I get an afternoon cup, that's where then the joy comes in. [00:30:01] Jennie Lynch: Yes. [00:30:02] Lindsey Dinneen: That's fantastic. That's amazing. Well, thank you both so very much for spending some time with me today and sharing your stories and your advice, and I am so excited to see Momease continue to succeed, and I love what you're doing, and this is so needed, and you have this wide open space for it, and that's insane, but I'm so thankful that you guys are taking the time and the effort and the funds and everything to make it come to life because it is so needed. So, gosh, just thank you for what you're doing. [00:30:36] Ashley Mooneyham: Thank you for being a platform. [00:30:39] Lindsey Dinneen: Of course, and we are so honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational, and safe environment. So thank you so much for choosing that charity to support, and also thank you for continuing to work to change lives for a better world. We're grateful, and I wish you the most amazing continued success. [00:31:11] Ashley Mooneyham: Thank you. [00:31:12] Jennie Lynch: Thank you. [00:31:13] Lindsey Dinneen: Absolutely. And thank you also to our listeners for tuning in. And if you're feeling as inspired as I am at the moment, I would love if you would share this episode with a colleague or two, continue to spread the word about these amazing innovations, and we will catch you next time. [00:31:31] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Dr. Shoreh Ershadi is the founder of ANITAGING Institute of California and a renowned expert in clinical biochemistry and pharmacology with over 40 years of experience. Dr. Ershadi shares her compelling journey from Iran to the United States, highlighting her unexpected entry into medical technology and the numerous challenges she faced as a woman in science. From setting up clinical labs and pioneering AIDS testing to founding her own antiaging company, Dr. Ershadi discusses her relentless pursuit of scientific innovation and passion for improving human health. The conversation also touches on her entrepreneurial ventures, the role of art in her life, and her vision for a healthier future driven by natural apoptosis-promoting supplements. Guest links: www.Apoptosis.us | www.facebook.com/apoptosisnutraceuticals | www.instagram.com/apoptosisnutraceuticals | www.threads.com/apoptosisnutraceuticals  Charity supported: Save the Children Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 037 - Dr. Shoreh Ershadi [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I'm so excited to introduce you to my guest, Dr. Shoreh Ershadi. With over 40 years of expertise in clinical biochemistry and pharmacology, Dr. Ershadi stands at the forefront of scientific innovation in the field of nutraceuticals and supplements. Board certified by the American Academy of Antiaging Medicine and holding dual doctorate degrees, Dr. Ershadi brings a wealth of knowledge and experience to the world. Dr. Ershadi's distinguished credentials, including National Registry in Clinical Chemistry and Toxicology and American Society of Clinical Pathology certifications, underscore her dedication to precision and quality in laboratory practices. Her visionary leadership and unwavering passion for advancing human health has made her a trusted authority in the field. All right. Well, Shoreh, thank you so much for being here today. I'm so excited to speak with you. [00:01:51] Dr. Shoreh Ershadi: Thank you for having me. I'm very excited to talk to you, especially that you're going to talk about medical technology. And that is something that I have been doing or working at for, I would say over 30 years, easy. 1988, I got my license in California. So it's what, 32 years? [00:02:17] Lindsey Dinneen: Yeah. Excellent. Oh my goodness. Well, this leads perfectly into my first question and that is, can you tell us a little bit about yourself and your background and how you got into medtech? [00:02:29] Dr. Shoreh Ershadi: Okay. That is interesting because I was born in Iran and I studied pharmacology. And before I was graduated, the Department of Health in Iran was hiring pharmacists, pharmacologists. So we all went and took the exam and we passed the exam. We were still at the final stages of doing the thesis and going through final stages of graduation. And then they called me and a few other people for an interview. Apparently I had a high mark in the test, which I did not know. So when we went for the interview, and I went to an American school and then later to a British school in Iran, so I was speaking English. At the interview, there was a gentleman who was back in Iran from United States, and he was a PhD in clinical biochemistry, and he asked me to read something in English. And I read it, and he thought that I had it by heart or something, so he flipped the book and found a more difficult page and said, "Okay, read this," and I read that, and he said, "Okay, I'm hiring you for the reference lab." I had absolutely no clue what he was talking about, what was reference lab. I had no intention to even work for Department of Health because I was not even graduated at that time. And then they said, "Okay, start on such and such date." And when I went there the first day, he said he spoke in English and he said, "You're overqualified." Oh my God. What? I mean, it was funny. Without even planning to get into laboratory, I got into the reference lab of Department of Health. And what he was planning to do was to bring College of American Pathologists, the proficiency testing to all the laboratories in Iran. And he wanted someone who would speak English and who could communicate. So first day of my job, I wrote a letter to College of American Pathologists and I said, "Hi, hello, I'm Shoreh Ershadi, I want to buy a thousand proficiency kits." And of course they responded. So just like that, I got into clinical laboratory. And I became the Director of the Quality Control for Department of Health. And that was before the revolution. So, that was my exciting start into laboratory. [00:05:25] Lindsey Dinneen: Yeah, that's an incredible story. Thank you for sharing that. And [00:05:28] Dr. Shoreh Ershadi: Not voluntarily, but serendipitously, yes. [00:05:34] Lindsey Dinneen: There you go. So then at some point, you came to the U. S. and was that transition really difficult? Was it frustrating? Were you excited? Nervous? [00:05:47] Dr. Shoreh Ershadi: There was a part in between before coming to U. S. There was another test by W. H. O., World Health Organization. So I took that test and I passed that test and I got a scholarship to go to medical school in England to do a master's degree. And when I went there, I told them, "I already have a doctorate in pharmacology. I don't want master's. I want to do PhD." And after a few weeks, they said, "Okay, fine, go to PhD. You don't need to do master." So I was in England for about four years. I did my PhD in clinical biochemistry. And I went back to Iran. That was exactly during the revolution. So while I was studying in England, the country in Iran was on fire. It was, things going crazy everywhere. But I went back and I got married. I had my son in Iran, and I was working in a clinical laboratory in one of the best hospitals in Iran, and it got very difficult for women to work. They were saying, " Now you have to wear a scarf. Now, you can't see male patients, you can only talk to female patients." It was not right. So, 1984, I came to United States, I came to California, and with some friends in Iran who had a clinical laboratory, and they were here before me and had started a lab in Orange County, California. I started a branch of the lab in Westwood, in Los Angeles. So that was my first job or position and that was my entrepreneurial side, which now I wouldn't dare to start a life, but then I did. [00:07:51] Lindsey Dinneen: You didn't know the difference then. [00:07:53] Dr. Shoreh Ershadi: Well, yes, I didn't know. I mean, it was a lot easier, I would say. At that point. The lab was not even accepting Medicare or Medi Cal. It was private insurance. I was doing the billing. I was getting the information. I was drawing the patients. I was separating the samples and sending them to the reference lab that was actually running the tests. But I was doing stat CBCs and I was in a medical building and so all the doctors were so nice to send the samples down to me. It worked. So [00:08:33] Lindsey Dinneen: Amazing. Oh my. [00:08:34] Dr. Shoreh Ershadi: Amazing. Yes. Now it sounds really amazing. It's surreal in a way. Yeah. [00:08:42] Lindsey Dinneen: Yeah. Yeah. Well, so, so with that lab and embracing this entrepreneurial journey, and I'm so thankful it worked out so well for you, but were there any moments where you just thought, okay, I've, I, you have such an amazing background. You're so highly educated, you're brilliant. And then you're starting this entrepreneurial journey, which is kind of a different skill set in a way. How was that transition of becoming kind of your own boss and being in charge of everything? [00:09:12] Dr. Shoreh Ershadi: That was pure ignorance. I mean, now I can say then, I thought I knew what I was doing, but it was a fast learning. First that I was in a different country, that I had never been in the United States. Second, that I had a three year old son that I brought with me and my then husband never came, so I got a divorce and I became a single mom. So, and nobody else was from my family was here. So it was very difficult because I had to take him to daycare and then come work and then go pick him up. And then there was a war, the Iraq war had started in Iran and my parents were in Iran and I was going through a divorce, so it was turmoil. And I had to work and learn in a way it was good because it didn't give me time to think about anything else. It was just forward, no looking sideways, no looking backwards. It was just moving forward. But then again, something else happened that made it even more interesting. One of the days that I was at the lab, some guy came and said, "CDL, Central Diagnostic Lab, is looking for a technical director and they've asked me to come and talk to you." I had absolutely no clue if anyone knew me or knew of me or it was the, I mean, a lot of things happened, which, I mean, I'm happy now, but then it changed my life tremendously. And I don't think I've ever talked to anyone about this in this detail. So, Lindsey, I would say you're the first person I'm telling the story of my life. But anyways, I went for an interview and I got hired right away. I had the lab, so I hired someone to do the work that I was doing in the lab. And then I started working at CDL, Central Diagnostic Labs, which was the largest privately owned lab in the United States at that time. There were 1, 200 employees. So that was a very interesting experience on its own because I was introduced to a world that I did not even know what was going on. So, and that was during AIDS testing. Bio-Rad had just come up with Western blot testing and we did the clinical trial, which was very easy in those days. We had AIDS patients and we had a lot of AIDS samples accumulated or saved frozen and we used them to validate the Western blot by Bio-Rad and I went on National TV 1988 and I said, "CDL is the first lab in the world that is doing a confirmation for HIV AIDS testing." So then, that was major. [00:12:40] Lindsey Dinneen: Yes. [00:12:43] Dr. Shoreh Ershadi: But then, then my family came. My father passed away here. It was, again, a lot of complications going on. And one of the other people that I knew asked me to go and partner with them in a lab. Again, my entrepreneurial part took over and I went for the partnership, and I started from scratch. I started Path Labs practically from scratch. There were two pathologists working with Los Alamitos Hospital, and I went there and I started a lab from just buying test tubes, buying, from absolutely nothing. I was there for six years, I think. six or eight years with Path Labs. That was not so successful. After that, I went to Specialty Labs, which is now Quest. Specialty wanted to start a toxicology lab. So, Path Lab was sold. But there was no money made with the partnership and all that. So that was not a very successful six, eight years of my life. Specialty was good. I went to Specialty and I started Department of Toxicology. I don't know if you remember or you were familiar with specialty. Dr. Peters was there and he was the founder, James Peters. He did only immunology testing. They would receive samples and send out everything else to other labs and only do the immunological tests or some specialty tests. When I started the toxicology department, we started getting samples from all over the world. We were running heavy metals and all that. We had an ICP MS and I started running ICP, and the main test that I developed there was measuring iron in the liver biopsy of patients with hemochromatosis. So we would get one spot, in tip of the needle of the liver and then do a measurement and measure the amount of toxicity with iron in hemochromatosis, which was great. I wrote a paper and we were working with Mayo Clinic and they developed the test. So that was very exciting. Then I started the automated lab because all the chemistry. And all the hematology was going out, was sent out. So that brought a lot of money into the lab, but that was not my lab. It was Dr. Peter's lab. It was wonderful. It was nice. But he was the entrepreneur there. So in the year 2000, I started ANTIAGING Institute of California. After passing the specialist chemist license in California, I got National Registry in Certified Chemistry, Certified Toxicology, and then I took the board exam with American Academy of Antiaging Medicine. And that was again entrepreneurial and I started the company, that would be 25 years ago. I've done a lot of consultation. I've been director of lab during COVID. I went back to city health. And I was Director of City Health running 4, 000 COVID patients a night for airports, for schools, for traveling, for a lot of stuff. And then I worked with Siemens Healthineers on regulations for IVDR. So all the kits that Siemens had, over 700 reagent kits that were sold to the laboratories, they need to get the CE mark to be able to be sold in Europe under the new IVDR regulations. And a lot of it had to go through FDA as well because FDA had to approve if there were any changes made to the kits. So I've done a lot of regulation works. I've done a lot of hands on COVID tests, covered it all. Actually, something else that was very interesting. And this, for MedTechs, I would think this would be interesting to know that it's not just one position. And there's so much you can do, if you want to expand your horizon. For about a year, I helped set up extremely high complex laboratory for testing mother's milk, for making milk bank from mother's milk for NICU for children who were born early and the formulas did not work with them. Some of them were so tiny, less than a pound. And so mother's milk bank, it's called Prolacta Bioscience, the company. And I worked there to establish the clinical lab and to get a license for clear and stuff like that. So. [00:18:21] Lindsey Dinneen: Oh! [00:18:21] Dr. Shoreh Ershadi: A lot of good work going into my up and down career, I would say. [00:18:28] Lindsey Dinneen: I love it. Well, first of all, I'm so honored that you were willing to share so much with me. That is. I really appreciate it. And I really appreciate you being willing to talk about some of the amazing moments you've had and the really high, " Yay, we did this," but also some of the moments where it was a little bit tougher and even you being honest and transparent about, the one company didn't do as well as you would have hoped, but you kept going and you are a living testament to resilience and adaptation. [00:18:59] Dr. Shoreh Ershadi: There is no other choice. I would hope that people would have many choices. I mean, you always make choices in life. Even now, this is a choice to talk to you and I appreciate the opportunity because, if I would choose or if I wouldn't know about you, that would be a totally different episode in my life. So I'm open to take chances. You can say that with my experience, living in three different continents and moving and just leaving Iran and coming to us with a three year old, not being here ever before. And then, just jumping in and, but there was no other choice except for moving forward, or we can say, except for success. Because failure was not an option. What would I do? There was nowhere to go back. Sometimes you may have an option to make a U turn and say, "Okay, I don't like this. I want to do something else. I want to stay home." There was no option, no going back. So it was only forward. [00:20:09] Lindsey Dinneen: Yes, absolutely. So, coming here and like you said, having to move forward and I appreciated what you said, you kind of, you couldn't look to the side, you couldn't look back. You had to keep moving forward. How did you go about building a community that could support you, that you could be friends with, and colleagues with, and feel supported coming in from, not having that. [00:20:36] Dr. Shoreh Ershadi: And that was not very difficult. There were many difficult times during that, that I mean, I don't mind talking about it, being a woman, being a young woman, being from a different background there was a lot of resistance. And I see that today as well. I mean, I can't say, "Oh, here I'm in L. A. and Los Angeles is so easy." It's not. I am hoping that women would not maybe experience all the difficulties that I went through. But we're talking about 40 years ago. I came to The States actually July 22nd would be exactly 40 years. I left Iran July 1st, 1984. So this is the 40th anniversary. Being a woman, I thought, when I went to England one of the first things, the professor was my direct supervisor when I worked with him. And I know you can see my face. This is 40 years later. I have no claims, but the professor told me, "You're a beautiful woman. Why do you want to study? Why are you here for PhD?" And I thought that was the greatest insult in my life. So I fought with that professor for four years. [00:22:15] Lindsey Dinneen: No, I'm sorry. [00:22:17] Dr. Shoreh Ershadi: That wasn't easy, but it was so difficult to prove that I am not just a woman or a pretty girl or a young girl or a young woman, or. That was a major fight. I would say that was as difficult as fighting the revolution in Iran, because you wouldn't expect a British professor to say that to you. And I was the only girl, a PhD student, all the others were guys, and this was medical school. And to me, that was very surprising because when I went to University of Tehran, we had probably more girls than guys in the class. Girls were very prone to education in Iran, and they still are. There's still, I think, 60, 65 percent girls in universities, even here. But to hear that was very difficult. That experience repeated itself. in United States over and over till today that I can say I don't feel old. I'm antiaging, but now that I'm an old woman, I still feel that I have to prove myself that I am equal. And sometimes I would say I'm better, but, just to be honest and modest, you want to be treated equal. And that is very difficult. [00:23:53] Lindsey Dinneen: Yeah. Yeah, you're absolutely right. And As much as I would wish things were improving rapidly, I'm not so sure that they are, but what have you found has been helpful in terms of, helping people understand who might come with a bias, but who, helping those people understand, "No I have this education. I am very capable." What are some strategies that you have found that have worked really well for you? [00:24:22] Dr. Shoreh Ershadi: Not many. I have to be honest with you. I mean, if there are a few people, few women, a few even men who are, would be following the conversation, I want them to know that this is not easy. And maybe a part of my success is that I'm a fighter. And I didn't surrender, but I didn't smile my way up. I fought with everyone that went in that direction. And I don't want to get into details, but many of the stronger men would think that if they flirt with you, if they take you out, if they buy dinner for you, then you're going to do what they say. And my story is, just, I have my guards up and I fought. I wouldn't recommend people to fight. Maybe they can find a better solution. I did not find many. Maybe the reason of working separate and starting my own company, maybe one of the major reasons was that I would not have to say yes to power that I did not want to say yes. I worked very hard. I worked hard, long hours. Medtechs, you have to stay there to get the results out. One Christmas. I stayed from December 24th for I would say 72 hours in the lab, maybe two, three hours shower and sleep and go back because we had a lot of toxicology tests that were waiting and results had to go out. And the probe in the I-C-P-M-S was broken. There was no one to replace it during Christmas. It was, we had to borrow from somewhere, FedEx shipping it. Those things happen, you know that, and you have to work hard. It wasn't an easy journey to say, "Oh, I worked four hours a day." And they said, "Thank you. You're so good. Go home." It wasn't like that. [00:26:44] Lindsey Dinneen: Right. Right. Yeah. Well, thank you. I appreciate you sharing that. And so one thing that was really interesting to me, I was looking at your LinkedIn profile and I see that art is a big part of your life in addition to the science and I saw you listed painting and sculpting and I'm wondering how-- well a couple of things-- how did you first get involved in art? And secondly, do you feel that is helpful in terms of having a sort of therapeutic thing to do that kind of maybe helps with some of those harder moments where it's a little frustrating? [00:27:23] Dr. Shoreh Ershadi: Very helpful. But I was as a kid, I started painting at a very young age. And I was always coloring and painting and making things and all that. And my father, a very educated father, he had two master's degree from a University of Texas and came back to Iran. And that's why, we spoke English and we went to English school. So my father was educated and open minded, I can say. But he always said that "You should study art. And don't go to medicine, you'll get old." He passed away in 1988, and I always, when I started Antiaging, I always said "Okay, if you're looking, you will see that I'm antiaging, I didn't age, I went to medical school, I did all the studies." But my logic, first that I love to do this, I mean, it wasn't just you know, forcing myself. I love science. And to this day I do a lot of research. I play with science. You can see the labels are all fancy. I do the paintings. I do all of that. But my logic, more than being scientific, was that this was a career and art would not be a self supporting career, even at younger age. But I always said that if I was a doctor, I could paint, but if I was an artist, I could not do the scientific part or the medical part that I was interested in. But after the divorce, I was in a relationship for 14 years. And I was working hard, raising a son, being a single mother and all that. When that relationship ended after 14 years, the art just popped out. I started painting, sculpting. It was not under control. You can see that, things happen to me, things come out in a certain period. Maybe, I push them down, force them to stay within me, and then they just pop out in different directions. So art came out itself. But there was a period in between that there was no art. Maybe there was too much stress. Maybe there was a lot of, and right now there's no art. Right now it's more entrepreneurial, starting, scientific, all that. But the art pops out every now and then. [00:30:07] Lindsey Dinneen: That's great. Yeah. So speaking of, what you're doing now, I was wondering if you could share a little bit about your company and maybe what you're excited about for its future as you continue along this path. [00:30:19] Dr. Shoreh Ershadi: Okay. That is, this is now where all the passion is. So everything that I have forced inside for all my life is now just coming out into Apoptosis. Apoptosis is a Greek word and it means "falling of the leaves." In science apoptosis, if you Google it, you'll see it means "programmed cell death." So in our bodies in creation or creator or whichever you wanna put it, and I'm sure being a medtech and all the audience, they know there are thousands of reactions inside the body are happening for me just to sit here and breathe and talk. There are thousands and thousands of enzymes and catalysts and metals and oh, whatever is going on. Programmed cell death or apoptosis is a main part of survival. So it's the future of antiaging because we all-- first of all that life expectancy is much longer now. Longevity is longer and younger people do not want to get old. So, at some point I would say my grandmother's generation and my mother is now 95 years old and she's, thank God, healthy and walking and all that, but even she does not want to get old. So, the image of being old and sick is combined together. But we can age without being sick, without getting Alzheimer's, without losing our memory, without getting all these different kinds of diseases. And one major problem is cancer that was much higher with older people and now the statistic is showing that cancer is happening in younger and younger generations. So what apoptosis does is that it's a program in the body. I did not make it. I wish I did, but it's happening all the time. And apoptosis is getting rid of cancer cells, getting rid of damaged cells, getting rid of neurons that cannot connect and synapses with other neurons to take the message over. So if we encourage apoptosis, then all the damaged cells are removed just like falling leaves. They're removed from the body and they're replaced with new energized healthy new cells. Every 10 years, our entire body is regenerated. So why do we get old? We should always stay at a 10 year age. So at 20 years old, we have recycled cells that even though we're growing, growth and youth is defined as between 20 to 25. From 25 to 30, it's sort of stable. There's a plateau. After 30, we start the aging process. So now, as 30 to 60, is still considered not so deep slip going down. It's sort of a plateau up to 60. And then after 60, 70, 80, 90, people are beginning to age. And it shows, I mean, with different diseases, with wrinkles, with memory loss, with all that. So what I'm doing, I'm using nature's product, plant based products, and this has been proven in science that these plants support apoptosis. So, as we get older, just like all the other reactions, apoptosis does not happen at its ultimate way that it should happen. But if we encourage it, for example, we have here, this one is brain beet. This is all beet roots, and it's an organic product. It's all plant based, but it releases nitric oxide. And it works the same way that Viagra works, but it opens all the arteries, it opens the circulation to the brain, to the heart, so why not use it? Why not promote apoptosis the way nature has programmed it in our body, just help it to work better. So that is all my passion right now. [00:35:28] Lindsey Dinneen: Excellent. Excellent. Well, I love that. Thank you for sharing a little bit about it. I'm excited for our listeners to go and learn more about it and, see how they can maybe also take part in the antiaging movement. [00:35:41] Dr. Shoreh Ershadi: Yes, they can partner with us and I would be thrilled. Actually, this is something that maybe I have learned during the long life experience, is that the more partners you have, the more friends you have, the more you share your knowledge, the better it is. Because at some point, it was like people wanted to keep everything to themselves and they didn't want to share or, but right now it's totally different. If they go to Apoptosis.us, they can go to the science section, they can read the papers. And if they would like to partner, I'll be thrilled to work with as many people as possible and take the message out. Yeah, this is a healthy message. This is something that we should all be talking about. [00:36:36] Lindsey Dinneen: Indeed, we should. Yes. Thank you. Well, pivoting the conversation just for fun, imagine that you were to be offered a million dollars to teach a master class on anything you want. It can be in your industry, but it doesn't have to be. What would you choose to teach? [00:36:56] Dr. Shoreh Ershadi: Well, the million dollar would be great. [00:36:59] Lindsey Dinneen: Indeed. [00:37:00] Dr. Shoreh Ershadi: Yes. Yeah. Would we all want that. But yes, I think that right now, as I said, I would use the million dollars to talk about apoptosis all over because I see even young children, every time I see St. Jude's children, and thank you for your donation to Save the Children. I admire that. And I'm hoping that all the children in the world would have a good, healthy future. The world is crazy. You can look at it right now and see that, I can say my experience has been crazy. It doesn't get any better. It's always up and down. Things are happening all over everywhere in the world. And I would like to talk about health, talk about antiaging, talk about Apoptosis and educate more and more of the young people to learn and to avoid all the toxins that we are creating and we have created, with what we're doing with industry and go back to a plant based life, go back to nature, enjoy nature, go back to art, if possible, all the good things that we can do with our lives. [00:38:21] Lindsey Dinneen: Yes, absolutely. And then, how do you wish to be remembered after you leave this world? [00:38:29] Dr. Shoreh Ershadi: Oh, wow. That's a very difficult... a fighter? Survivor? Yep. Strong women? I would support women all the way. Now in Iran, they're saying, Woman Life Freedom. I'm sure you've heard about that. And I cannot tolerate, to see women covered all over with a window to see outside. To me, that is very disturbing. So I would like to see equal opportunity for women and I would like to maybe be remembered as a survivor. [00:39:14] Lindsey Dinneen: Yes, absolutely. And then, final question, what is one thing that makes you smile every time you see or think about it? [00:39:24] Dr. Shoreh Ershadi: Oh, my granddaughter and my grandson. Yes, I have a five year old granddaughter. Her name is Julia and she is my sunshine. She is my life. The grandson is three months old. He's still too young, but he's getting there. [00:39:45] Lindsey Dinneen: Aw! [00:39:48] Dr. Shoreh Ershadi: Getting emotional. [00:39:51] Lindsey Dinneen: I'm so glad. It's that's beautiful. That's wonderful. [00:39:56] Dr. Shoreh Ershadi: Yes, that is continuation of the fight. That is when you see that what you've done is worth the fight, worth the hard work. [00:40:08] Lindsey Dinneen: Absolutely. Absolutely. Yes. Well, this has been amazing. I so appreciate you telling your story and sharing some of it that maybe you haven't done before, and that's I feel very honored. [00:40:23] Dr. Shoreh Ershadi: Yes. [00:40:24] Lindsey Dinneen: Thank you. Thank you for trusting me. [00:40:28] Dr. Shoreh Ershadi: Well, thank you for bringing all of this out. This has been sitting there suffocating, maybe. [00:40:36] Lindsey Dinneen: Yeah. [00:40:37] Dr. Shoreh Ershadi: Thank you. [00:40:38] Lindsey Dinneen: Absolutely. And we are so honored, you mentioned this, but to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational, and safe environment. So thank you for choosing that organization to support. And we just wish you the most continued success as you work to change lives for a better world. [00:41:06] Dr. Shoreh Ershadi: Thank you so much, and thank you for having me, and thank you for making me tell the story. Thank you, Lindsey. [00:41:15] Lindsey Dinneen: Of course. And thank you also so much to our listeners for tuning in. And if you're feeling as inspired as I am right now, I would love if you would share this episode with a colleague or two, and we'll catch you next time. [00:41:29] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Tom Salemi, editorial director of DeviceTalks shares his accidental yet fulfilling journey into the medtech industry. Tom reveals his passion for storytelling, building communities, and highlighting the human aspect of medical device innovation. He discusses the evolution of DeviceTalks, its focus on collaboration and education, and the importance of personal connections within the industry.    Guest links: devicetalks.com Charity supported: Feeding America Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 036 - Tom Salemi Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to The Leading Difference podcast. I'm your host Lindsey and I am so excited to be speaking with my guests today. Tom Salemi. Tom is the editorial director of DeviceTalks. He tells medtech stories with wonder, humor, and great respect. He hosts podcasts, conducts video interviews and organizes events, both virtual and in-person to ensure our innovative medtech ecosystem stays strong and saves lives. All right. Well, thank you so much for being here, Tom. I'm so excited to talk with you this morning. Tom Salemi: Oh, it's my pleasure. Thanks for having me. It's great to be on this other side of the podcast interview experience. Lindsey Dinneen: Yeah, absolutely. Well, I would love if you wouldn't mind starting off by sharing just a little bit about yourself and your background and how you wandered into medtech. Tom Salemi: Sure. I'm a Massachusetts native, lived here my whole life. Always was aware of the healthcare industry, but I can't say I had a long time love for it or anything like that. My parents were not doctors. I am not an engineer, nor ever could be, but I did go to journalism school. And I wasn't quite sure why, it just always appealed to me. I went to visit a newspaper once, the Boston Herald, and I fell in love with the newsroom. It just seemed like the most fun place to be in the world. So I wanted to work there for a living, but later on, I think I found out it was more, I really enjoy building communities and that's gonna, I think, develop later on. I found my way into medtech quite accidentally. I was at a local paper in Massachusetts and wanted to get a job at the Boston Business Journal 'cause I was tired of covering city council meetings and planning board meetings about the height of fences and things like that. And the only beat that was open was healthcare. And at the time, this was '97, that included all the Boston hospitals, the biotechs, and the medical device companies. So it was a lot, but it was intriguing. And, I'll say my parents at the time were older and starting to see doctors more and more. So I was like, "Well, it wouldn't be the worst thing in the world to understand that industry a bit better." So I took the job at the Business Journal and then that led to an invitation to edit a venture capital newsletter that focused again, broadly on healthcare. So, that was in '98, it's called Venture Capital and Healthcare. Very very descriptive name. And from there, I just really grew to love medtech. I mean, biotech, is of course bigger and fascinating in its own right, but I never quite understood the whole molecule thing, whereas devices, you could see what this thing did and what it looked like. And how the pump worked and why I moved the blood this way or that way. It was just I think an easier and a better story for me to tell. So that's how I wandered my way into healthcare and into medical devices. Lindsey Dinneen: Wonderful. Thank you for sharing. Well, and now with DeviceTalks, can you tell us a little bit about DeviceTalks, and maybe a little bit about what you're excited about for it for the future? Because I know there's just so much in the works and it just keeps growing and it's so exciting to watch. Tom Salemi: Yeah, no, it's been an interesting development. So I joined actually DeviceTalks in 2019. It existed prior to me. It's been around for 10 years or so. It was a sort of the events business related to the Mass Device news site. So, prior to that, I was writing for magazines, wrote for InVivo and Startup. And then decided in 2014, I was I was done with writing. I just wanted to do something different. And at the same time, the company that acquired our magazine decided they wanna lay off the editorial staff. So it was it was quite a good bit of timing for me 'cause I don't think I ever would've got off the branch without a little boot in the butt. So I started doing conferences for a smaller company, medical device conferences, and podcasts. And then the opportunity to join DeviceTalks again happened in 2019 to, to run their three meetings. Of course, 2020 came around. I joined November, 2019, four months later the world shut down and we didn't have our events. So, we pivoted and launched our podcasts and our webinars and went back to events in 2022. DeviceTalks' mission has been really focused on the people who make medical devices, who design them, who manufacture them, who get them through the regulatory process. Anyone who touches a medical device from inception to handling it to a physician to have it implanted in a patient. We try to track that whole process. We do a bit of sort of the venture capital stuff, which was where my interests were lying previously. But DeviceTalks' goal is really again, to focus on the engineers and manufacturing folks, those who were really on the front lines of making medical devices. DeviceTalks has sort of morphed over time from just an events business to our podcast business, which is not only our weekly podcast, but we're working with a lot of the major OEMs to help them tell their stories through podcasts. We're continuing to roll out new series focused on specific OEMs or specific areas. We'll have a neuro one coming out soon. We'll have a structural heart one coming out soon. And we still, the DeviceTalks Tuesdays program that we launched in May 2020, because we couldn't meet the person, we did virtual like everybody else. I thought it would be something that would go away when we went back to in person, but it's only grown. So we'll continue. We continue to do about 35 of those a year. We take a month off in August and then a few days here and there for holidays. But next year we're going to be expanding that to bring some more kind of issues and OEM oriented conversations. So people seem to have responded to the opportunities to talk about medtech all the time and to listen to medtech all the time. So, as the host of a podcast, it's a pretty great time to be producing stories like these. Lindsey Dinneen: Yeah, absolutely. Well, thanks for sharing a little bit about DeviceTalks and its trajectory. It's so exciting to see how it continues to grow and evolve over time. And yeah, it's been interesting to watch how so many companies have changed, obviously because of the pandemic, but then sometimes it's been a really interesting change where, what you thought was going to happen doesn't actually happen the way, but it's exciting. And, you just keep moving with it. So that's great. Tom Salemi: I was listening to the first podcast we did in March 2020,. Chris Newmark and I were talking about, "Well, what does this mean? Like, are we not going to go to meetings? Are we going to have these conversations online? Like digitally? That's crazy. That doesn't make any sense." And we just literally described the world today, but we were both just flabbergasted, "This is nuts. This is just not going to work." So you're right. Things are evolved quickly. Lindsey Dinneen: Yeah. Yeah. And it's great. So, you're coming at the medtech industry from a really unique perspective, and you are telling stories and sharing stories about people's, incredible devices and innovations and the journey from concept to actually producing something. And I'm curious how does that storytelling process work for you? Like how do you go about finding the hidden gems within a founder's story, and then being able to take that and really run with it so that it's not just a matter of, "Hey, this device is incredible. Look at all the shiny, cool, amazing things it does. But here's the purpose and the reason behind that, too." Tom Salemi: That's a good question. I mean, I, like you, start the podcast with the stories about the guests, 'cause I'm really intrigued by their path into medtech. 'Cause I don't think it's, we know the industry itself isn't extraordinarily sexy. It's not on the front page of the Wall Street Journal. We're not talking about, well, these stupid app names that are missing vowels and people seem to get excited about it. We're a very kind of, I don't know, low key industry, but we're the industry, the people who make these devices, are literally saving lives. So I think the guests that we talk to, you know, come to it come to this industry for a purpose. You obviously can build a very successful career for yourself. But I really do enjoy trying to find out what that why is and how it came to be, how it came to lead to a career in medtech. And then I really focused down on, we've all had those moments where we've made life decisions and we could have gone this way or that way. And we chose that way. And it worked out, but what was that? What was the thought process at that fork in the road? And why was that decision made? 'Cause I think really, I think that's something that everyone can connect with. I remember talking with Mike Mahoney, the CEO of Boston Scientific at DeviceTalks Boston last year, talking about his indecision as to whether he was going to take the job at Boston Scientific. He was obviously a senior medtech guy at J& J. Why leave J& J for Boston Scientific, which was struggling at the time? And he just told this great story of how he had hired a consultant to review the situation and to give him a recommendation. The consultant was like, "No way, man, stay at J& J, you're doing great." And he was going to interview at Boston with the intention, I think, of saying no. And then he just took a moment and walked off and just looked in a mirror and said, "Do you want to do this or not?" And he said, "Yeah, I want to do this." And he just went for it and look what happened. So, I think finding those human moments in medtech is important because, more so than tech, in other industries, I think it is a very human industry because, again, people are here for a personal reason. Many people have personal stories as to why they entered medtech. Talk to people who have lost childhood friends, when they were teenagers and that drove them to medtech, obviously the state of our parents, in my case, draws you here. I think very often there's a compassionate thread. I mean, sometimes people just, maybe they go into sales 'cause they see the cars in the parking lot of, and I think there's that and that's fine too, but I think those people also come around to, "Oh wait, this is, I can have my cake and eat it too. I can actually do some good while doing well." So, I do like to focus on the human part of our industry. And I think it's one that needs to be told more because too often it's a conversation focused on FDA approvals or recalls, and we're just talking about the machinery and not the people who make it. Lindsey Dinneen: Yes. Very well said. And I completely agree with you. I think there's, oftentimes a little bit of, because to your point, it's not sort of on the front pages every day. And I will venture to say that sometimes when it is, it's for the reasons we don't want it to be. So, so it's so important to tell these stories. And the thing is, I came in from also from an outside perspective and my background is marketing and business development, business strategy. And so when I came in, it was a whole new world as well. And one thing that I realized is from an outside perspective, sometimes there's this sort of unfair stigma about people are in it solely for the money. And honestly, It's a really hard industry to be in if that's your only goal. So I think, telling these stories about these founders and the why behind it is just so compelling. And I love being able to do that. I'm so glad that you do that all the time as well. Yeah. Tom Salemi: Yeah, no it's just, those are things that need to be reported on and focused on more, so I'm glad we're both shining a light on it. Lindsey Dinneen: Yeah, absolutely. So, okay. So I know that DeviceTalks, it has so many different facets to it. One of the really interesting things that you guys do is put on events. And I was wondering if you could speak a little bit to that process and even just there, there are a number of different industry events available, but DeviceTalks pretty special. So I was wondering if you could talk to a little bit about that element and what makes it unique. Yeah. Tom Salemi: Yeah. No. So when I joined in 2019, I came aboard to help find a direction, a different direction for the meetings to focus it more on the engineering and the device making, which was going to be challenging for me. 'Cause my, again, I really focused more on who raised series A, and who raised series B, and who's a late stage investor, and who's an early stage investor. And for me, for a long time prior, medical device coverage was just, you report on the company's financings, your report on their FDA approval. And then, I don't know, all that stuff in between and who knows what happens there. So, COVID in a way presented an opportunity because we were able to focus on the podcasts and really give me an opportunity to learn about the industry, to learn about the engineering and the manufacturing about it, but also to get to know the device companies themselves and the comms teams there. So, by the time we resumed things in 2022, it sort of afforded me the opportunity to really work with the comms teams at the big companies, and the engineers and the folks who had on podcast, and try to get those stories that we told on the podcast on stage and maybe a grander fashion. Maybe there's a PowerPoint vote. Maybe there's two or three people who can talk about pulse field ablation, who can talk about the orthopedic business, who can talk about surgical robotics. So DeviceTalks, although we include some of that in our conversations, partnership and financing, especially in Boston, we've got The Medtech Innovator there and they run a great innovation, sort of forum investment forum. I just love working with Paul Grand and I love The Medtech Innovator crowd. And I still love startups, the folks who start companies are just absolutely insane in a good way. God bless them. I love it. And so, but I really wanted to give an opportunity for the Strykers, for the Boston Scientifics, for the Medtronics to come and sit down in sort of a collegial atmosphere and say, "Look, this is, this is the device we're working on. These were the challenges we had in developing it. This is how we're looking at the patient population." And just go over different challenges that that they had overcome. So it really, I think, is an opportunity for everyone to sit down and talk about the designing, the making, even the selling. We're actually getting more into the selling of medical devices to talk about the business of medical devices in a very, almost. I don't want-- collegiate sounds weird-- but just a very educational, sort of open setting. So we'll do, we have our keynotes, we'll have our big CEO keynotes. We'll have a venture panel from time to time. And like I said, we'd love to have the startups present, especially in Boston with MedTech innovator. We do that a little less of that at DeviceTalks West, but our bread and butter can sit continues to be engineering and manufacturing. And we really want folks to come down and talk about the intricacies behind their very cool and important and lifesaving devices, so people walk away with a better understanding of how to make their life saving device. And hopefully if they've taken the time to get to know this person who's achieved something great, and maybe they connect on LinkedIn, and it leads to a company being started five or six or 10 years down the road or two or three years down the road. Who knows? So we're all about again, open conversations about medical device development and about fostering the opportunity for personal connection as well. Lindsey Dinneen: I love that. Well, and I love your focus on collaboration, and education and that, the knowledge is shareable and it's really important and I think it's really impressive that you've created an atmosphere where people do want to come and share and talk about the good, the bad, and the ugly of their process and being able to share those stories, like you said, could very well inspire the next generation of innovators because it's important to be honest and transparent when you can be. So I think that's really incredible that you've fostered this atmosphere that, that leads to that. So. Tom Salemi: No, thank you. No, and I'm really grateful to those companies that take advantage. Sometimes folks will come and maybe their presentation is a little scripted. But I think just having that person in the room, the Chief Technology Officer or the Director of Engineering for some valve program is important. And it just gives people, I think as much as-- if I were to create a pie chart for the importance of stuff that goes with a bar graph that happens on stage versus like the 10 minutes after someone's on stage, it's probably the bars are probably pretty close. I'm not sure which is more important, but I think just getting everybody together and we've actually, I initially fought this, I'll admit it, but first couple of conferences, we had like five minutes in between sessions 'cause I just wanted to pack so much in. This year, our conference team was like, "Can we do 15 minutes?" And I was like, "No!" If you add it up, you've probably lost like 30 minutes of programming, but the 15 minutes was really great for just to give people some comfortable time to like, "Hey, I heard what you said about X. Here's something I'm working on, what do you think about that?" I think that those kinds of conversations are are very important and you can lead it up. You can leave it up to serendipity that, "Oh, if I'm at the conference and the Chief Technology Officer from major medtech is going to be there, I'll bump into him in the cocktail reception," but it's not always easy to do. So we try to, we really try to foster those connections so people get the insights they need and go home with some really positive insights and feedback. Lindsey Dinneen: I love that. Yeah, I absolutely love what your company does for that. That's incredible. Tom Salemi: Thank you. Lindsey Dinneen: So along your journey, have there been any moments where it stood out to you that you had this realization that "Yes, I am in the right industry at the right time." And just something, like a story that you got to share or something that just made you go, "Oh yes, I'm in the right place here." Tom Salemi: Interesting question. I mean, I have a lot of those moments. Some of those singular moments, I think, some are a just collective moment. Like I've said before, when I was covering the Newburyport City Council, there was literally a moment where they were arguing about the distance-- I was there supposed to be covering this meeting-- and they were talking about the height of fences. And I literally got up and just left. And I was like, "I can't spend, I don't want to dedicate another minute of my life to this." And I've never done anything like that before. I am this Joe Earnest, like I'm gonna stay to the end and make sure it goes. I had the whole journalism thing going on. But I was just like, "I just can't spend my life doing this." I've never, ever had that moment in medtech. I've never come to work and said, "Why am I writing about this? Or why am I talking to this person? Or what, what is this even about? What's the point?" I've never even thought that. And I would have that conversation if I were covering insurance or even, when I was at my newsletter, got a company by Dow Jones. And I thought my only path up was really to like get into news wires and start covering earnings and things like that. And I was like, " I don't want to be covering earnings and being measured by like, did I beat AP or whomever or Bloomberg by 35 seconds?" No, that's not what I want to do. I want to write about cool tech and talk to cool people. So that's when I left Dow Jones and joined EnVivo and Startup, cause I really wanted to focus on medtech. But, there are a lot of those moments where I'm really glad to be doing what I'm doing and there's singular moments too, where, I'm sitting in a plane and I look across the aisle and the woman next to me is just reading an EnVivo Magazine and she's got my article open. And I'm like, ah, I just want to tap her in the shoulder. " What do you think? What do you think about Right Medical, huh? Pretty interesting stuff, huh?" That was very cool. I remember interviewing Kevin Lobo at the early medtech conference I did in Minnesota. It just went super well. He's a really great guy to talk to and very easy to talk to, very open and honest, and will answer any question. But just getting off the stage was like, "Wow, that was a lot of fun. I want to go up and do another one." Which is weird, 'cause I wasn't a big stage guy before, but I don't know, the opportunity to dig and find some cool stories and really see the humanity in these medical device folks is a great challenge and a great privilege for me. I'm really blessed to have the access that I have. So I'm very grateful. Lindsey Dinneen: Amazing. Oh my gosh, I loved that so much. And yeah, I totally, it would be hard not to go, "Hey, what do you think?" Tom Salemi: Exactly, right? Yeah. Then what? Then like, "Oh yeah." Then she's like, "Sure. Sure. You're Tom Salemi." And then it gets really weird. "Oh really?" I let it be, but it's one of those forks in the road moments. What would have happened if I just asked her if she liked the right medical story and maybe who knows? I don't know. Lindsey Dinneen: That's so great. Tom Salemi: I might've had, I might've met a future CEO and then had a great story to tell with her someday. So. Lindsey Dinneen: It's still a possibility. Tom Salemi: it still happen. Lindsey Dinneen: Maybe you'll run into again. Tom Salemi: She's hearing this, maybe. She's like, "Wait a minute, I did read an EnVivo Magazine on the plane once next to some weird guy who was..." Lindsey Dinneen: "...weirdly watching me while I was reading it." Tom Salemi: Exactly, while was reading a magazine. Lindsey Dinneen: That's so funny. I love it. Well, pivoting the conversation just for fun. Imagine that you were to be offered a million dollars to teach a masterclass on anything you want. It can be within your industry, but it doesn't have to be. What would you choose to teach and why? Tom Salemi: Wow. People say "that's a great question" to me all the time. And I always like, "I don't really have that many great questions. Like one or two of them are great!" But that's a good, that's a really great question. Oh, wow. I think For me, learning to speak publicly and enjoy the time on stage, I think has been a real blessing for me. So, and I know a lot of people have that ability as well. I think that would be great thing to, to share with folks. But I think moreover, I mean, it's crazy to me that like people look to me like some sort of storytelling expert where I really just like, it's like, "You're really interesting. I'm not conjuring magic. You have a great story that you just don't know exists. I'm not some wizard who's just waving my wand and saying something in broken Latin and it all happens. It's all in you." And I wish folks could look inside and see their own stories and see the stories of others as well. And they're probably too busy designing that next great device that they don't really have that ability to look inward. But, I think helping people identify their own stories, not necessarily to tell them in a podcast form, but just to have a better sense of, of who they are. I mean, I've talked to a few people who like you, I'll say, "Oh, I'll start the conversation learning about you." And they'll say, "Well, I'm boring. Just talk about the company." And I said, "You're not boring. I've never talked to a boring person." Believe me, like everyone has great stories and everyone has great decisions that they made and, it's just a matter of telling it, or at least knowing those stories are in there. So, because I can't teach on anything of technical value, I guess I'll focus on that. Just helping people identify their own stories and and sharing them in the world in a way that's appropriate for them. Again, they don't have to have a YouTube channel, but they could just say, "Hey, I do important work. I'm interesting. And, I've made a difference in the world." That's pretty awesome. Lindsey Dinneen: Yes. Well, I love that. And I actually think the wizardry component of it comes in with allowing people to feel safe enough to tell their stories, and comfortable, because it can be harder, especially when you're maybe telling a story that is challenging for you, that talks about something where maybe things didn't go the way that you hoped they would, or you failed at something. And so, so giving people, providing that safe space, basically, to allow people to share those stories and encourage it is, I think you've got that wizardry component. Tom Salemi: Oh, I appreciate that. And that's a great point. And I think, like with the keynotes, when you're talking with someone who's willing to trust you a bit and say, "Look, when I do keynotes," I'm like, "Look, these are the things I want to talk about." Just allow me to, if I hear something interesting, I go, "Wait a minute, can I just pull that thread a moment," and just to have someone trust you that you're not going to take it in a really weird way, that you're going to see the positive, I think, is when you really have done your job and have a great keynote. Those are the moments, especially like at a conference where people walk away and say, "That was great." Keynotes should be really great and interesting. They can be informative as well, but if you're just focusing on, why you designed this over that and why that, why it's important to help people with this dreadful disease, all of that's important, but I think the stories that really resonate with people are the ones when they, where the people in the audience can really form a connection with the person on stage. I think that's when you really hit the home run. So, just trying to do that. Lindsey Dinneen: Yes. Yes. Yeah, absolutely. And I think to your point, another component that you do really well and that I think is important in that sort of wizardry aspect, is the respecting and honoring of the person's choosing to tell that story. So it is, like you said, drawing out the positive and honoring the fact that they've decided to share with you. And so therefore they continue to feel safe, and respected in sharing their insights and stories and whatnot. So I think you're absolutely right that it has to have multi layer components. And, and I love your thing. You've never met a boring person. That's so great. That's so true. Tom Salemi: It's true. I mean, just talk to people. My son is going to be an engineer and he's like already 10 times smarter than I am technically. I teach him how to jump a car battery and he's explained to me, "Oh yeah, that's why the red has to be attached to the black." And I'm like, "I don't know that. I just know red and black. Don't tell me why the battery works. I don't really need to know that. I just need to know how not to set my car on fire." That's where my technical knowledge. But there are people in the world who understand how things work. And I just-- that's witchcraft. To understand, why planes fly and why batteries work. That stuff's amazing to me. Lindsey Dinneen: I agree. I agree. All right. And so, on a bit of a more serious note, how would you like to be remembered after you leave this world? Tom Salemi: Oh, wow. I mean, like I said at the start, I got into journalism cause I thought it would be fun. And I was also a shy kid and I didn't want to be in a cubicle all my life, 'cause I think, I don't think I'd ever climb out of it. I wanted to really force myself into the world. But then I came to realize that what I really liked was helping people connect and I think that's becoming harder and harder for people to do, not to get too heavy about it, but I think there are a lot of lonely people in the world who aren't finding connection or the connections they are finding aren't necessarily the most productive. So I hope, I hope I, I ease that somewhat and I'm always --just last week, actually, I got a couple of great messages and I don't get a ton of these. It's just weird timing, but someone who said that they enjoy the podcast, and they're college students, and they went into biomed because of the podcast. They joined a startup competition. It's like, "Wow. I, with my stupid stories, I had an impact on someone in a positive fashion!" And I told this person, " Great. When you invent the lifesaving technology," I said, "I will take total credit because I'm the one who stirred you into medical devices." I'm getting a few of those nice messaging, and it's, I hope that people remember that, we have a lot more in common... I hope people will think that I've reminded people that we have a lot more in common than we do differences, and that we have a lot more positivity to rally around the negativity. And it's the only way we're going to get things done in this world is if we're working together on it. So if I could help that happen a little bit, I think I'd be happy with that as a life lived. Lindsey Dinneen: Yeah. Yeah, absolutely. Wow. And thanks for sharing that story. That's incredible. That is so exciting. Tom Salemi: I'm so grateful. I told him, I'm so grateful that person wrote, "thank you so much," 'cause that, yeah, that people don't do that very frequently. So it's awesome. Lindsey Dinneen: Yeah, and final question. What is one thing that makes you smile every time you see or think about it? Tom Salemi: Huh. My first thought was my, my kids just seeing them find their way through life, seeing them find the things that energize them. It's great when you see that. Dogs, of course would be a good one. Lindsey Dinneen: Yes. Tom Salemi: I love a good dog. I don't know, everything that's coming to mind, it sounds kind of corny. I mean, obviously when you see people take a kindness on somebody else, or be kind to someone else when they don't need to be, I think is extraordinarily uplifting. So my kids, my dogs, my dog, any dog, actually most dogs will do... Lindsey Dinneen: Yes. Tom Salemi: Yeah. But my dog in particular, but no, I think I just, those moments that, unfortunately, we're not shining enough light on where people are overly kind and helpful to each other. I think we need to see more of that at this time. Lindsey Dinneen: Yeah. Agreed. Well, I think that's phenomenal. I, I also am a huge dog lover. So anytime, I mean, really, it's like an instant happiness. Tom Salemi: Yeah. Lindsey Dinneen: Instant. So happy. So. Yeah, they are the best. Well, I just want to say this has been an incredible conversation. It's been so great to get to know you a little bit and also get to know a little bit more about the incredible work that DeviceTalks is doing. So I just want to thank you so much for being here and being willing to share your stories. This has been great. Tom Salemi: Oh, thank you so much. It was an honor to be asked. It doesn't happen frequently and it was-- you've got some great questions. I may steal a couple of them. So. Lindsey Dinneen: Absolutely. Well, thank you again. We are so honored to be making a donation on your behalf as a thank you for your time today to Feeding America, which works to end hunger in the United States by partnering with food banks, food pantries, and local food programs to bring food to people facing hunger. And they also advocate for policies that create long term solutions to hunger. So thank you for choosing that organization to support and thank you for all the work you do to change lives for a better world. Tom Salemi: Okay. Thank you so much. Lindsey Dinneen: Thank you also to our listeners. And if you're feeling as inspired as I am right now, I'd love it if you would share this episode with a colleague or two, and we will catch you next time. Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Jennifer L. Horspool, a communication and public relations expert, global brand strategist, and founder of Engagement PR & Marketing, shares her journey from aspiring scientist to a leading figure in MedTech PR, emphasizing the importance of storytelling, branding, and patient persistence in the industry. She highlights how she helps startups and Fortune 100 companies turn their innovative ideas into well-known brands. Jennifer also discusses the transformative role of AI in MedTech and PR, providing valuable insights and practical advice for startups looking to make their mark.   Guest links: https://engagementpr.com/ | https://www.linkedin.com/in/jenniferlhorspool/ | https://www.facebook.com/EngagementPR Charity supported: Paw Prints in the Sand Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 035 - Jennifer L. Horspool Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to The Leading Difference podcast. I'm your host, Lindsey, and I am so excited to introduce you to my guest today, [00:01:00] Jennifer L. Hoorspool. Jennifer is a communication and public relations expert, a global brand strategist, international speaker, and founder of Engagement PR and Marketing. As a brand growth and turnaround specialist, Jennifer has been employing her skills in PR, media, marketing, and messaging for more than three decades to grow companies from vision to multimillion dollars and "turn best kept secret brands into the go to experts of their industries." Jennifer works with companies of all sizes from startups to Fortune 100. She's been working with medtech, biotech, and pharmaceutical companies for more than 15 years, and has helped to bring some pretty cool products to market. All right. Well, thank you so much for being here, Jennifer. I'm so excited to speak with you today. Jennifer Hoorspool: Thank you, Lindsey. I'm so honored to be here. I'm excited. Lindsey Dinneen: Wonderful. Well, would you mind starting off by telling us just a little bit about yourself and your background and maybe what led you to MedTech? Jennifer Horspool: [00:02:00] Sure thing, actually. So I've been running Engagement PR and Marketing since 2015. I've actually been in the field of public relations marketing since the nineties, right? I'm 24 years old. I don't know how that mouth works. I don't really have to do numbers. I do words. Healthcare has been my vertical deep for all those 30 years, right? I've worked with some other people outside of health care, but for the most part, health care. I started off doing a lot in patient services and really like direct to consumer about health and wellness and stuff like that. And then got into drug approvals but from a PR perspective, right? So bringing drugs to life. And then that led me into devices, medtech. And then as AI has expanded, it's just been really fascinating in the medtech world. And I've gotten to work with medtech that does need FDA approval and medtech that does not need FDA approval. So there's all different kinds of stuff. And one of the most fascinating things that I've gotten to do is work with a couple of different contract [00:03:00] research organizations. And so those are the companies that hold the hands of the inventors so that they can get their products through the FDA and to market in the United States. It's a fascinating journey. There's all kinds of different avenues to go down. And it's just been really spectacular of the things that I've gotten to learn in the inventors and getting inside the inventor's minds. Lindsey Dinneen: Yeah, I can only imagine. Well, thank you so much for sharing a little bit about your background and whatnot. And so, okay. So I'm curious when you first, maybe as a kid, like would seven year old Jennifer have said, this is what I want to do with my life, or did seven year old Jennifer not know yet? Jennifer Horspool: Well, seven year old Jennifer thought she was going to be a scientist. I was the girl that had all the, like the, I made my own soaps. I made my own potions and lotions. I did not think of myself as a witch. I thought of myself as a science, a scientist. And so I was always inventing this and inventing that and [00:04:00] constantly spilling things on my poor mom's brand new floor. And, you know, "Mom, I cleaned it up as quickly as possible," you know. Lindsey Dinneen: Oh Jennifer Horspool: No, I've always enjoyed science and I've just found it to be fascinating. And then and then I got lost along the way. I forgot about science. Quite honestly, I was taking it, but like those were hard and communication just came so easily to me. And then it became more about storytelling. And so I love to tell stories and one thing after another, I got into branding and brand building. And this is like in the nineties is when that terminology kind of first started maturing outside of your brand mark, which is your logo. Before the, like the early nineties, early to mid nineties, we talked everything about a brand was really just your brand mark was your logo. We thought that was a brand. And then we came down to, no, it's actually-- the brand is the emotional components of who you are and who you are as a company and all the different things. And so I got to get into all of that and I got all into the words and the storytelling and the feelings and emotions of it. And now I got to represent [00:05:00] scientists. And so it's really been a really good match because I think I'm a natural communicator. Lindsey Dinneen: Yeah. That's wonderful. And I think it's so helpful sometimes to bridge the gap because you have that background and that interest in science. And sometimes perhaps not all scientists can communicate as well as they want to maybe those of us who don't have that background and do need to understand what it is you're bringing to market so that we can purchase it. Jennifer Horspool: Right, right, right. And it's uncomplicating the complications that they find simple, right? So it's, how do you take that scientific language and turn it into common language that everyone can get behind? And so, I've always said like really smart people can simplify everything. Lindsey Dinneen: I love that. Yeah. I, there's a saying that something along the lines of "simple isn't easy, but simple is worth it." And I... Jennifer Horspool: I love it. Lindsey Dinneen: ...think a really good thing to, to remind yourself of is, when you can simplify processes or communication or whatnot, it [00:06:00] is worth it in the long run, even though, you know, like that famous, was it Mark Twain, who said something like, "I didn't have time to write a short letter..." Jennifer Horspool: Yeah, "...so I had to write a long one." Exactly. Exactly. Because it's the truth, you know? And that's funny because in marketing all the time, they're like, "I need 11 words to fit right here." And people don't understand that it's much harder to write 11 words about something than it is to write 700. 700 is I get to explain it all. 11, I have to be impactful and those words really matter. And so it's actually much more difficult to write 11 impactful words than it is to write 700. Lindsey Dinneen: Yes, it is. I love that. That's a good analogy too. So now what are you currently doing and excited about and what are you looking forward to as you continue to build the business and move forward? Jennifer Horspool: Yeah. So because we do marketing, PR, branding, brand experience, love to work with brand new startups, love to [00:07:00] help them get their whole-- figure out that whole identity, get their websites going. Everything that's in the beginning, you would be surprised at how many emotions are tied into that first coming out brand. And it, people think it matters so much and it does matter, right? But it's like sometimes, "Get out what you know right now. Let's get something up. And then as your science matures, we can mature your brand. We can mature your website." First thing we want to do is get something out there where we can start getting presence, getting you seen, known, trusted, and found, right? Getting found is the most important thing, and it's not the easiest, right? So, so there's all these different strategies that you do to get found first by your name, you know, by who you are, your company name, the founders' names, and also by what you do or what your promise of your technology is going to do. And so I really enjoy working with people at all stages. I've, I've had the great fortune of [00:08:00] working with startups that are unfunded, startups that are funded, and then all the way through to Fortune 14 companies, right? So the entire gamut, I know who and how to work with. with. And we work with all of them. But our sweet spot really is in just either just launching or have already launched and are just starting getting ready to get known, really building that brand and pulling people to you, to your sites, to your social media, to the studies that you're doing, to all the different things so that we build that rise. And then you're found more easily because at the end of the day, if you're the best kept secret, you could have the best science in the world, but then no one gets to use it. So we take you from the best kept secret to the best known experts in the industry. Lindsey Dinneen: Ooh, I love that. Nice. Jennifer Horspool: Thank you. Lindsey Dinneen: And I think it's so true too, because I think sometimes working with engineers, for instance, who are beyond brilliant and sometimes there's this, [00:09:00] there can be a disconnect of, "Well, it's so great. Like the product is so great and it should just be known." And we're like, "Yes, you're right. It should be, but there actually has to be a process to go through." Cause unfortunately the whole, "if you build it, they will come..." Jennifer Horspool: Yeah, that movie threw everybody for a loop when websites came about because all of a sudden everybody thought, "Oh, if I build it, they will come." And it's like, no, that's a movie. The dream, if you remember, it was the dream field. Lindsey Dinneen: Right. Jennifer Horspool: So if you build it, then you have to market it so that they even know to come. And there's a lot of variety, like it really, it should be. fun. And it needs to be fun first and foremost, right? Like the excitement, you know, there's an acronym that I do about media. How do you get in the media, MEDIA, right? So your message is your magnet. The "M" is your Message. Your message is your magnet and your magnet is your magic that really pulls people to you. And then the "E" is Excitement. You have to deliver it with excitement cause if you're not excited about it, [00:10:00] how is anybody else going to be? But that passion really pulls people to why this is such an exciting breakthrough. What's it going to do that's different than something that's on the market today. Then you have to distinguish yourself. The "D" in media is that: Distinguish. How are you different than what's already on the market? Why is that important? You know, you have to be interesting. The "I" is Interesting. It's like you deliver it with excitement. But how are you differentiating from everyone else? You have to distinguish yourself. You have to describe what's so important. How is it interesting. And then you really do that for your Audience. Who is the main target audience? And it's easy when your audience niche is small, but when people see it as a broad alternative to a lot of things, they get clustered, right? Like, it's like, "Oh my goodness gracious. No, it's all these people. It's everyone." And the sad part is when you serve everyone, then you have to still niche [00:11:00] down into little buckets because everyone is not listening the same way. And when you start talking to everyone, you start talking to no one because it's too generic. People don't know to stop and listen. The whole thing is you're trying to stop that scroll. Everything, it doesn't matter if it's your video, if it's a meme, if it's a white paper, if it's your blog, whatever it is, we're all in the same scrolls right now, right? It doesn't matter if it's social media or on email or you're trying to stop that scroll. How do you get them to open your thing? And really, so the MEDIA: the message, the excitement, you know, all of that just really comes into play. Lindsey Dinneen: That was amazing. Thank you so much for sharing that. You're obviously brilliant at all of this and I really appreciate that summary. I could not stop nodding my head because I was just like " yes." So thank you. And I love your acronym. That's perfect. Oh my goodness. Easy to remember. So what are some of the challenges or roadblocks that you see, [00:12:00] maybe especially with some of these startups, because a lot of startups are listening to this podcast. And so speaking of niching down, speaking to your people, but so, so what advice would you have? What kinds of challenges and roadblocks do you see? And what kind of advice would you have for somebody who is in this situation of, "Okay, I'm ready to start being known. I don't want this to be a secret anymore." What do you see and how can they overcome some of those issues? Thanks. Jennifer Horspool: Yeah, that's an excellent question because patience is a virtue still today and we have less and less of it. Right? We think like, "We've been working on this for a year and a half and here we are, ta da!" And everybody's gonna be like, "Oh my god, they're here!" Right? You know what I mean? But that's not really how it is. We all, we have trust issues. issues. And in today's world, because there's so much online and because we have so much accessibility and because there's always new things being invented all the time, where's the credibility, right? So, and even if you're [00:13:00] the most credible person in the world, where's the credibility in the product? Where's the credibility in your launch? Where's the credibility? And sometimes it's much slower to ramp up than you want it to be than, you think it's going to be. So the first initial, sometimes even press releases or outreach to media introductions to media, and you might get interviews, you might get like all different kinds of things where you're seeing a lot of groundswell, but it hasn't turned into stories yet. It hasn't turned into articles on the web. And it's very frustrating because you're like, "I gave them my time. I gave them all my expertise. I was as transparent and authentic as possible. I shared all this, like, where's our story?" But they might still be just accumulating information on you and watching and waiting. They're seeing how your science matures because if they come out with it, it's an endorsement by their publication that this is authentic, that this is a real thing. And so, especially in credible publications, which is what you're trying to get into, right? And so [00:14:00] they're waiting and watching for the right time to release your story. They might interview you three, four, five times, collecting the data, building up the story before they actually cover you, before they actually release the interview notes, before they actually do something that you can really use on your site and to build out your stuff. So in the meantime, you do the media interviews. You build the relationship with your key media who are writing about your topics. And you really, that's what you're doing is building the relationship. You're making them feel comfortable enough with you, your science, the results, your white papers, like everything that you're putting out, all of your studies, especially if you're presenting, by all means, share that with your media without necessarily expectation. You want the expectation, right? You want the story to come out of it, of course. But they might still be just collecting information and building up your [00:15:00] file and then what, once it happens, it could be something grandiose. It could be something really great that then you can really use. And then don't be afraid to repurpose these when you get stories. Don't be a one and done. "Oh my God, we were the Wall Street Journal. Here it is." You're done. I think it's 8%, you know of LinkedIn followers even see your posts or even if they're exposed to your post, whether or not they're on social media that day. And it goes through down and through your feed. It's still in your social media, but repurpose it all the time. Pull out quotes from it, pull out interesting tidbits, share your infographics, like share that thing. Don't be afraid like 20, 30, 40 times throughout the year, you can take one study and really dissect it and share different pieces to it. Different people are going to see it. They're going to absorb the, and the same people are going to absorb it differently each time. It's like watching your favorite movie over and over again, and you grab new tidbits every time you're like, "I never even noticed that before." It's the same kind of concept with your [00:16:00] science. Lindsey Dinneen: Oh, brilliant. Thank you. That was great. I really appreciate you sharing that advice with us too. Yeah, and I think to your point, it is hard to be patient because you're so excited about whatever it is that you're building and working on. And patience is such a wonderful thing to keep in mind. Like it's okay, you know, it will come just, you know, one step at a time. Jennifer Horspool: When you get started on your marketing, it can take like three, four months before you really are starting to see real results because it's like AB testing all the time, right? What are people responding to? What are they not responding to? It's kind of the same thing with traditional media when you're trying to get in with a media. Lindsey Dinneen: Yeah. Excellent. Thank you. Well, so I'm curious, are there any moments or a series of moments that stand out to you because they clearly reminded you why you chose this field and why you're specifically doing it for healthcare, medtech and whatnot. Jennifer Horspool: So I think I feel like we're at kind of a pivotal point in health care right now. It's been [00:17:00] very much like one specific way. We've been a pill popping society for lack of a better way of putting it. We all wanted a pill to solve all of our problems. In fact, there was some show in the nineties and it was like all about the year 2025. And we were such a pill popping society that by the year 2025, you pressed a button and this pill came out and that was your entire meal. And you took your pill and that was your meal. And you just went on, you had all the proper nutrition. Like we thought, "Oh, we're not even gonna have to bother to eat anymore." Well, foodies hadn't really come about yet. So foodies came about and they're like, "No we want to eat. Eating is the great part. Like, why would you take that away? Nobody wants to eat a pill." So I think with medtech, where it, is we're able now, especially combining it with AI, is that we're able to create new things that, that test the body in new ways. We're able to create new things that show us like even where your body's misaligned. And the part that's so important about the way your body is aligned is that has to do with nutrient delivery. [00:18:00] It has to do with injuries. Most injuries we think, "Oh, it's because I was playing soccer and I twisted my knee this way." But it was actually because, well, your hip and your ankle were out of joint to begin with. You went and you played soccer and your body was already misaligned. You slept wrong or you had poor posture while you were watching television. You got all cranked up the wrong way. And then you went out and you played basketball, cause you always play basketball on Saturdays, cause you're a weekend warrior. Weekend warriors are the ones that get the most injuries. And that's because we don't do the training all the way along. And then you go out and you play and then you have injuries. So it's like getting ahead of all those things. Medtech today has such an opportunity to change the entire trajectory of the way we look and analyze the body, that I think there's no more fascinating industry than medtech right now. Lindsey Dinneen: Yeah. Oh, I love that. And Thank you for sharing a little bit about some of the, even the technology that you get exposed to too, because that is [00:19:00] just so cool. And I am curious, you mentioned at the beginning how, and this is a hot topic because it's on everyone's mind, of how is AI impacting medtech? And I'd be curious to know how AI is impacting even the work that you do for medtech and healthcare. Jennifer Horspool: Right. So two totally different things, right? Like when you say AI, to anybody today, they just go, "Oh, ChatGPT, right?" Lindsey Dinneen: Right, right. Jennifer Horspool: There's so much more than ChatGPT, right? I've been fortunate, I've actually been working with AI for 15 plus years because we didn't call it AI back then. We called it different things. We just talked about what it did. We didn't say, well, "the artificial intelligence is putting it together." Like we didn't do that. It's a term now, right? What we talked about was the application of it and taking all this data and getting the analysis out in an intelligent analysis that's going to help people. Or now [00:20:00] you can use AI processes that were developed for something else. You can plug and play it into your application and it can vascularize things that never were vascularized before. I mean, that's one of the things in certain types of medtech that people are working on galore is really in creating 3D printing organs, for example, 3D printing life saving aspects. I'm working with one company and they're developing a, it's a 3D printed bio biopolymer wrap that actually, it's got bio absorbable materials. There's just, there's new materials, there's new stuff, there's new technologies. And AI is really the ability to speed up data analysis, the ability to combine mass amounts of data or mass amounts of processes and simplify it into something that humans can do, but nowhere near at the speed. So we're taking things that might have taken three months or three years, and we're able to get it down to three seconds or even [00:21:00] less. We're able to take things like military applications or there's the God awful bombings that are going on, how are we getting medical care to areas where they're so remote that there's no medical care? So AI is actually able to connect things up where there is no technology. There's no wifi, there's no this, there's no that, but then you can do x rays and you can actually get your x rays and upload them and get them, get a diagnosis. get like intelligent insight back when you don't have access to the internet and to other things. And so it's really, AI is the ability to dream bigger and make those dreams actually truly happen. And then in my field, It's a really great way to never have to start with a blank piece of paper. The blank piece of paper is the hardest thing in the world to start with AI right now, especially if you're going like ChatGPT, it's great for content. It's not so great for context yet. You still have to personalize [00:22:00] everything. Never take what AI does and just use it straight out. Everyone knows, first of all, everyone knows the way it writes. So then you just look lazy. And you look like you didn't really share your own stuff. No one cares what AI had to say. They care what you, the expert, had to say. So, we do a lot of ghostwriting. We write a lot in other people's words. We might take it to AI to get that started or maybe get some ideas. It's fabulous for ideas for blog posts. It's fabulous for ideas for social media. It's fabulous for ideas, you know, then take those ideas. It's fabulous to get started, but not to finish. You need to take it and spend a good hour with it and really make it yours. Lindsey Dinneen: absolutely, wonderful, thank you for sharing a little bit about that too, I, it's just always such an interesting, it will be a discussion point for years and years, probably forever, I don't know, but it is so exciting, I love the way that you described it too, of being able to not approach it out of a fear [00:23:00] or concern, but approach it out of, "Oh my goodness, I can actually make these dreams come true. And I can have a bigger, even more positive..." Jennifer Horspool: ...impact, right? We, every, we're looking for impact and it's really, don't be afraid of it. I talked to some people and they're like, "Well, everything we do is just so personalized." Everyone wants to think that everything is so different, what we do is so unique. I know everybody's is so unique. It's so unique. We're all the same uniquely, but... Lindsey Dinneen: Yeah. Jennifer Horspool: ...we're all uniquely the same. I don't know, you know, whichever way you want to put it. But it's really about amplifying who you are. You can take it and create avatars to let it think in a certain person's tone. And then you can feed it that avatar. And you're saying like, you're telling it, "I want you to be this avatar, in this way of thinking with this tone and these personas, these personality traits" that you're giving it, "I want you to create now. something spectacular" and it can give you something that could might, it might even be 70, 80 percent done, right? But just never take it [00:24:00] straight out and just plain old use it. But what it's also really good for is in finding gaps, right? Where you're like, "Here's everything I know about this and here's everything I know about this. Why aren't they, why aren't they working together? Find the gaps in this for me." Excellent at doing that, especially in medtech, where you can really then find out like what's happening today. What are the problems that we have with the medtech that's out there today. If you want a product, but you want it to go even bigger, maybe you want to change standard of care somehow by making something, taking what we have now and amplifying it to a whole another realm where you're taking the aspects of maybe three other products and you're marrying it with standard of care today. And you're saying, "this is how it's going to go that much better." It will find all those gaps for you, right? You can create programs. There are AI program writers that you tell them, "I need this as my end result and they can design a program that's intelligent, that continues to [00:25:00] learn." There's a, another gentleman that I've been working with and he developed, it basically helps you make decisions and it helps you weigh all the decisions. And it's not like it's so profound that you couldn't have done it on your own, but you don't do it on your own, right? You plug the things in and now you get the answers back. And that's AI. Lindsey Dinneen: Ooh, fascinating too. That is so cool. Yeah. I mean, the possibilities are endless and it's just the beginning, so it's going to be exciting to, to stay on it. Yeah. Well, pivoting the conversation just for fun, imagine you were to be offered a million dollars to teach a masterclass on anything you want, could be in your industry, but doesn't have to be. What would you choose to teach? Jennifer Horspool: That is a fascinating question. I would talk about-- I, I would talk about the power of being you. You know, we are, we're born uniquely us. That is the one thing where you really do get to own the unique. You are [00:26:00] uniquely you for a reason. I grew up in the seventies and eighties. Like I said, I'm 24 years old. I'm sure you know that math. But it wasn't the time for girl power. It really was not the time for girl power. And then girl power came about and it was so great because watching the transition of girls into sports and really owning sports, right? And girls into science and STEM, like now females are owning STEM and there's femtech. Femtech is a real, true industry, not just a word, but an entire industry. And that is how are we serving women? So we've been marketing to women for years because women are the caretakers of the family, but we haven't been taking care of those women. We've been empowering those women to take care of their families. So it's, we've been shamed, " Oh, you can't be conceited. If you love yourself, you're conceited." That's what growing up in the seventies and eighties was like, it was very much about, you're not allowed to love yourself and loving yourself in today's world, as we know, is the key to everything. [00:27:00] And so the more uniquely and fantastically you are you, the better innovations you're going to bring to your life, to the people who know you, to the scientific world, if that's where you belong. You didn't get into science by accident. You didn't get into inventing by accident. That is part of what is uniquely you. You have a curious mind. And one of the things that we forget to do, we do it in science all the time. The hypothesis is designed to be proven incorrect. Incorrect. We think, "Oh, I'm trying to prove my science." No, you're trying to prove it incorrect. And if you can't prove it incorrect, the assumption is that it must be true until we can find something else or something better. The same thing applies to your life. The same thing applies to yourself. And in fact, I'm going to challenge, but the same thing applies into the way that you're researching your politics. The same thing applies to the research and you're applying to your beliefs about everything in life. And if you can start to say that, "This is my [00:28:00] current hypothesis. This is what I believe based on all these things. And I haven't been able to prove myself wrong. Therefore, I believe these to be true." And if you start researching everything like that, you're going to find so many more discoveries in life and you're going to find so much more of your sweet spot and where, what makes you really happy and find your people who are going to go on this journey with you. And so I think that's what I would like to do. And thank you for the million dollars. Lindsey Dinneen: Yeah! Well, that's a brilliant sounding masterclass, and I totally want to sign up, so let me know when you offer it, because I'll be there. Jennifer Horspool: You got it. Lindsey Dinneen: And then, how do you wish to be remembered after you leave this world? Jennifer Horspool: Gosh, that's another nice question. I think as an empowering person who helps people to see the value in being truly and authentically themselves. I think the more we really embrace who we [00:29:00] are and all of our flaws and all of our own cuckoo, cause everybody gets some. We love to point the finger, right? And one of the, one of the greatest things I learned, and I don't even remember which coach I learned it from, but you know, when you're pointing the finger at everyone else, you've got three more pointing back at you. And so the most empowering thing about that is it puts you in charge. And that means it puts you in charge of being able to fix anything. And so, yeah, that. Lindsey Dinneen: I love that. Yeah. Excellent. And then final question. What is one thing that makes you smile every time you see or think about it? Jennifer Horspool: My dog, Bruno. Lindsey Dinneen: Yay. Jennifer Horspool: My dog, Bruno. He's the greatest thing that ever happened to me. He was homeless. He was sleeping under my friend's truck for about three weeks. She posted, "Hey, I have to find this guy his forever home." And and we met and it's just been a fabulous engagement ever since. He's the greatest thing ever. Lindsey Dinneen: So sweet. I love that. Dogs are the best. [00:30:00] They're perfect companions. Jennifer Horspool: Yeah. Lindsey Dinneen: Excellent. Well. Jennifer Horspool: He's spoiled now. He went from outside to a couch and a bed and all these other beds and he's a happy guy. Lindsey Dinneen: Yeah, I love it. I love it. That deserves some love and attention and, yeah, pampering. Jennifer Horspool: Right. Lindsey Dinneen: That's phenomenal. Well, Jennifer, thank you so much for being here today. Seriously, it was value after value. It was nonstop amazing advice, amazing insight. We are so honored to be making a donation on your behalf as a thank you for your time today to Paw Prints in the Sand. Paw Prints in the Sand Animal Rescue is an all animal foster based animal welfare organization with a mission to give at risk animals a second chance at life by providing medical care behavior training and loving forever homes. Thank you for choosing that organization to support! Thank you for joining us and thank you for everything that you do to change lives for a better world. Jennifer Horspool: Thank you. [00:31:00] And thank you for doing this. This was fantastic. I really appreciate the opportunity to come and speak with you and talk medtech to all the scientists out there. It's one of my favorites. It's always fascinating. And thank you for doing the podcast. It's fantastic. Lindsey Dinneen: Yeah, excellent. And for those startups and founders that might need some assistance, where could they find you? Jennifer Horspool: Email me at jennifer at engagementpr. com or or just go to engagementpr. com, fill out the form or you can go to LinkedIn, Jennifer L. Hoorspool, everywhere I am, get my L in the middle. It's I say, whether it's my middle initial or my last name, please put the L, it's really important. Lindsey Dinneen: Okay. Excellent. Sounds good. Well, again, thank you for being here. And thank you also to our listeners. And if you're feeling as inspired as I am right now, I'd love it if you would share this episode with a colleague or two, and we will catch you next time. Jennifer Horspool: You're the best.   Ben Trombold: The Leading Difference is brought to you by [00:32:00] Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Dasha Tyshlek, founder of StratCraft and strategic advisor to life science and healthcare tech companies, shares her inspiring journey from a dance teacher to a leading entrepreneur in MedTech. She discusses her passion for technology and problem-solving, and how she helps companies innovate and commercialize groundbreaking products. Dasha also highlights her podcast, "Biomedical Frontiers," which showcases transformative technologies and offers hope for the future of healthcare. Tune in for a compelling conversation on entrepreneurship, innovation, and making a difference in the world.    Guest links: http://stratcraftpartners.com | https://rss.com/podcasts/biomedicalfrontiers/ | https://www.engineering.virginia.edu/centers-institutes/coulter-center-translational-research/podcast  Charity supported: Polaris Project Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 034 - Dasha Tyshlek Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello and welcome to The Leading Difference podcast. I'm your host, Lindsey, and I am so excited to be speaking with my guest today, Dasha Tyshlek. [00:01:00] Growing up, Dasha knew she wanted to become an entrepreneur, leading people to change the world through innovative products and services. Her love for technology and problem solving led her to study engineering science, focusing on biomedical engineering and product development at the University of Virginia. Today, Dasha is the founder, president, and chief strategic advisor of StratCraft, and is a strategic partner for growing life science and healthcare technology companies. Dasha has developed a strategy for advanced manufacturing spinouts such as Core Composites and MicroAnt GPS. She has led company wide strategy development and unique growth initiatives across multiple high tech industries, including biomedical device, pharmaceutical, translational research, automotive, financial, satellite, and defense. Dasha is the director and host of "Biomedical Frontiers: Stories with Innovators in Healthcare," a life sciences and biotechnology commercialization podcast hosted by the Wallace H. Coulter Translational Research Foundation at University of Virginia, and she is a lecturer [00:02:00] at University of Virginia's Biomedical Engineering Department. Due to her deep technical understanding and ability to forge complex, multi company partnerships and agreements, she is a sought after advisor to innovative companies working to commercialize their new technologies. All right, Dasha. Thank you so much for being here. Dasha Tyshlek: Lindsey, it's such a pleasure. Lindsey Dinneen: Awesome. Well, I was wondering if you would be willing to start off by just telling us a little bit about yourself and how you got started in the medical device field and what led you to what you're doing today. Dasha Tyshlek: Yeah, absolutely. I think one of the things that's been a defining trajectory in my life is, is entrepreneurial pursuit. And I actually started out, I think you and I connected on this earlier, as a dance teacher early on in my life and decided even in high school since I was learning dance to, to try coming up with my own dance aerobics programs and try to pitch that to local Golds [00:03:00] Gyms. And so that, that's been something I've, I've endorsed and participated in and tested out various forms of entrepreneurship over my life. But I'm also an engineer and I love interesting new technologies and the scientific approach to problem solving, kind of methodical, process driven, deeply curious ways of creating solutions. And so, when I started my engineering degree, I met some people who were entrepreneurial engineers. And that really excited me that you could be a technologist who is working on solving a problem and you're not doing it just to then maybe write a paper and hope somebody notices, but then you do the steps necessary, bring the team together, find the customer, and, and then do it, do that transition, that bridging. And so that really put me on a path even when I was studying to start exploring that. And I got to [00:04:00] participate with an organization called Venture Well, which is really famous for supporting STEM entrepreneurship even at undergraduate level. And at my university, I worked to create an organization that would help sprout kind of entrepreneurial innovation roots into the student community. So we created a Maker Space. We hosted a Medical Hackathon took people to startup trips to visit companies that were doing new technology developments. And, and also did some expos and speakers and things like that to expose students. And that had some really great success. A lot of people got very involved. A lot of the people that went through that with me are now entrepreneurs themselves-- not all medical device entrepreneurs, although most of them were biomedical engineers-- but all of them, very entrepreneurial, and working on some really interesting technologies now, so I think that's that's kind of the defining piece of where my career began. And then today I'm [00:05:00] consulting and helping companies, particularly companies with large portfolios of new technologies, who are trying to come up with ways to commercialize products, come up with that strategy for commercialization, taking one product, one technology at a time. Lindsey Dinneen: Wow, that is an amazing backstory. Thank you for sharing all of that with me. And it is so cool to see how, first of all the synergy, the fact that you did have a dance background as well. And you were so entrepreneurial, even back then in creating this program. So I do have to ask, did that program ever get sold to a gym or to anyone. Have you developed it? Did you fully do that? Dasha Tyshlek: Yeah, I actually had two Golds Gyms that I taught on a regular basis two different types of programs. And then since I was already a teacher with Golds Gym, they wanted to introduce some other dance programs from kind of well known brands. So they picked me as their [00:06:00] flagship dance instructor. So I actually ended up picking up some new classes and certifications through that. I also had a private class, just my dentist and her friends wanted to do dance, but they didn't want to enroll in a gym. So I was like, "Here, I'll come over, you know, everybody pitch in, here's the price and I'll just bring the gear and everybody dances at someone's living room." So we even had and they were all really busy women. So. So I think it worked well for them to just, you know, be in the neighborhood and use a living room rather than have to kind of travel. So you know, and, and we did, did some, there was two Golds Gyms, but there was also I was a substitute teacher and actually partnered with another dance trainer who was testing out ballroom dancing for people with disabilities. And so I was his like dance partner demo. So I just got to explore so many different opportunities through that and kind of see how you do business development and relationship management and new product rollouts and have to get, you know, prove that my class will bring in new [00:07:00] customers. So it was very fun. Lindsey Dinneen: Oh, that is incredible. I absolutely love that. Oh my goodness. So, so you have always had this entrepreneurial bent, but then of course, like you said you've also-- you're so curious. You like exploring you like learning new things and you're clearly not afraid to go out and pitch those ideas to whoever will listen. So I'm curious, how did you come to the pathway of "I want to be an engineer. I want to go to school for this and develop that skill set as well." Because it's not that they're not compatible. They obviously are. But a lot of times people don't necessarily put the two together. So I'm curious how that worked for you. Dasha Tyshlek: Yeah, when, when I was-- so, deciding to be an engineer was a little bit tough. I, I really like chemistry and I thought maybe to go into the chemistry side of things. But a lot of the people in my family are engineers. My grandmother is an engineer. Both my parents have kind of a practical math backgrounds. So, there was a lot of engineering in the [00:08:00] background of my family. And it seemed to me that the engineering focused a little bit more on kind of what's here and now, what you can build now. Science may be focused more on fundamental discovery. And so that that seemed to be kind of the difference for me is is I thought, "I'm probably like a little bit more like practical here and now rather than thinking in these like 20 year timelines." And so I think it was just a better personality fit. And then once I got into engineering school, that turned out to be really a great fit because I loved learning about the technology. I loved working with other engineers who were very building, creating, designing oriented. And the way that you look at problems and investigate in engineering is very similar to scientific approach, but also tends to be then, you have to then think through, "Okay, great, we found out how this spring works or something like that, but how do you use this spring to do something now in the world?" And so I, I love that [00:09:00] translation from kind of, "We have a technology, we have an approach to, it has to work for people in the world in reality." Lindsey Dinneen: It's so interesting because I love talking to people who are multi passionate and have a lot of different avenues that they have pursued over the years because I do think, overall, the more generalist you can be-- not that you shouldn't really hone in on some specifics-- but the more that you can have a lot of general experience and knowledge and skill sets, it seems to all end up working really well together in the end. And it helps you be a little more creative maybe when you're solving problems or approaching a new idea or a difficult conundrum and you're going, "Okay, well, you know what's interesting is, I have this background in science and engineering, and I have this background in dance and entrepreneurship and then blending it all together." I just love the stories of how it comes together. Dasha Tyshlek: One of the things I learned when I was [00:10:00] in engineering school is, for a lot of the projects-- so I took some project types of courses, and the first one I did that was like a year long course-- what I learned is, first semester, there was somebody to train me how to do the thing, but then everybody left the class, and I was the only one left. And so, the second semester on the project, I was basically spearheading, like, this kind of modeling project, and I had only been doing it for a few months. And I noticed right in that project that I was able to keep a team really organized, really clearly articulate goals, and at the end of the project, aside from the technical work that I was doing on it, I was actually the person synthesizing the results and communicating. And it led me to think, "Is there something there that's a real strength for me? And should I be doubling down on that?" And that, that's an area I've pursued a lot in my career is technology communication: clearly articulating what we're trying to achieve at the onset, developing requirements, [00:11:00] understanding the use case, et cetera. And then on the back side of it, once we've developed something, there's an entire kind of art and science to it, to talking about technology because there's a lot of detail. A lot of the people who work in the detail of the technology want to share that science and process. But a lot of the people who then make decisions want to hear other information about the technology that might not relate to how it works or how it was built. And so by, by actually having some of those experiences in engineering school, I was able to see that this technology communication and crafting of project goals was something that was really needed for engineering teams, and it really benefited when there was an engineer who was doing that, but you had to be in a different mindset and develop a different set of skills in addition to the design work. Lindsey Dinneen: Yeah, absolutely. Now, when you, and thank you for sharing that. I love that, that bringing it all together and again, how things work [00:12:00] together to help you. I, and I'm curious. So you are, you were so well prepared, from an outside perspective at least, to go out on your own and become this high level, amazing consultant for these companies. Did you also feel ready, or was it still this sort of leap of faith when you said, "Okay, I'm going to go in, full time for myself." Dasha Tyshlek: No, I was, I was very ready. I think, like any entrepreneur, I'm going through a process of discovery by learning exactly what it is my customer really needs help with, what industries and specific technologies I'm able to bring my skills to the best. And also what types of companies are looking for help I provide. So I can't say that I knew all of that information when I started out, but I had a good experience in, in the role I left. When, when I started my business, having had walked into an engineering company that had great innovative products, but was sort of [00:13:00] underperforming in the market relative to their potential and the quality of the technology they provided and going through the process systematically of creating a company strategy with them helping them understand what pieces were missing from their business development side, and working through the marketing and the business side of things to help them better articulate their technologies. But also taking a look at the portfolio of technologies and recognizing that some of the technologies there didn't quite fit their main business model, but were really valuable, helping them figure out a path to get those out to market separate of their company, but in a way that still contributed to the overall value of the business. And after I did that, I had several years of success and meaningful impact to look back on. And I said, "I've done it, I've proven it in one place." But in my experience doing this, I just kept meeting more and more companies [00:14:00] that struggled with a similar kind of problem. They had all the innovation. They had an amazing, talented engineering team, but they either lacked focus on which products had the most potential, or they would develop a lot of stuff that they didn't know how to move forward into the market. And so I could see the problem all around me. I was solving it. And so, after I've done enough at one company. I said, "Okay, I see the need and I know that I have the skills to solve it. Now I just need to kind of open that up and create a firm around this concept that helps other companies succeed in the same way." Lindsey Dinneen: Wonderful. Wonderful. Thank you for sharing. And so since starting your own consultancy, what has been maybe one of the most impactful, or things that really stand out to you as one of the most exciting things that you've gotten a chance to work [00:15:00] on? What kind of goes, "Oh, this is why I'm doing it this way in this industry." Dasha Tyshlek: Yeah. So, just generally, I get to meet so many interesting innovators who are changing, particularly healthcare. There are very interesting transformative technologies coming to the market that utilize virtual reality, that utilize AI technologies, to do things we weren't previously able to do in medicine to make me visualize your body in a way that no amount of human brain power could have done because of the way these models can work with data. But the project or the specific thing that I think I am most excited about in terms of its general impact is, it's called Biomedical Frontiers: Stories with Innovators in Healthcare. And it's a podcast i'm producing on behalf of University of Virginia's Coulter Center for [00:16:00] Translational Research. It's a center that focuses specifically on biomedical research that has potential for commercialization, or you could say translation, into the clinic, and they fund that research. They help with the business development efforts to bring that research into the world. And the podcast supports that mission by both highlighting the technologies that are a part of that portfolio, as well as that are connected to that portfolio, but also by educating people not only on the process of invention and the process of innovation in the medical and life sciences industry, but I think, very importantly, about what is coming: the hope and the good news about some of the incredible things that are coming to the market and to the world to help solve some of our intractable problems. So, I think in terms of human impact, that's probably the, something that I'm working on with, with a tremendous [00:17:00] vision that is available to all to participate in, to listen or, to be interviewed on. Lindsey Dinneen: Excellent, excellent. And can you just share a little bit too about your experience becoming a podcast host because you have kind of an interesting, unique story with that. And then how can people listen to this podcast? Where is it available? Dasha Tyshlek: Yes, of course. So public speaking and presenting technology, something that I've been interested in for a long time. And even before I started my business, in the Director of Marketing kind of roles that I've done, I've realized that video and audio communication, kind of deep diving in technology, helping create content that educates people because in a lot of engineering, even deep engineering technology areas-- you're working with other engineers who are deep in some technology area that you don't necessarily understand. There's a lot of miscommunication that happens because of that and podcasts are just such a [00:18:00] powerful way to bring more education and deep conversations about various topics, including very niche topics into the world. So I've kind of experimented with interviewing video interviews for some time now. But when I started my business, I was working alongside another business, Sales Chasers, and the founder of that business, Michelle Page, she and I were just kind of throwing around ideas. How do you grow your business? How do you find customers? What things we were interested in? We started kind of collaborating because you know, when you're starting a business, it's just you and headphones and your computer and it you know, you kind of miss-- especially if you're in a business development communicator role-- you're like, "Ah, I need people." I'm, I, I need some, some sort of co working to go on because it's, it's too lonely. So she and I were each other's co workers in that way, kind of similar stages in our, in our different consulting firms. So she and I decided to do a project called Go Go Grow, focusing [00:19:00] on business to business scaling with each of us coming up with some lesson plans on kind of key frameworks, tools, or ideas that are really important to business to business type of business growth. And so she and I developed that Go Go Grow together and put out a season focusing on kind of the fundamentals that we think are the most important, with some interviews of experts as well as some content that she and I kind of lesson planned together. And she's continuing on with that into other kinds of topics, but I was already working on this podcast, and I was teaching at University of Virginia, a class in the biomedical engineering department focused on engineers' professional development skills. And so when I was talking to my co lecturer who is the professor at the University and the head of the Culture Translational Research Center, he had this idea of "We should do a podcast." And I said, "Let [00:20:00] me help you. Can I please do this?" So I created a vision for what we could do, tying his foundations' mission and the goals that we were both pursuing in the class in terms of professional development for biomedical engineers. And then presented it to the engineering department, to the biomedical engineering department, and that's how we got started. Lindsey Dinneen: Amazing. Well, thank you for sharing that. And yes, please go check out her podcast. It's going to be just really informative. You'll learn a lot and you'll also get a lot of inspiration, like she said, about the fact that there's so many new amazing technologies emerging, there's a lot of reason for hope and optimism, and that's a good reminder, especially nowadays. So absolutely. Well, I'm curious, are there any moments or any one moment that stands out to you as just this [00:21:00] realization that you chose the right industry, you chose medtech for a reason, that it just kind of clicked into place, "Yes, this is why I'm here." Dasha Tyshlek: I think there's been a couple small moments, but each meaningful. I think when I got my first client that was really outside of my existing network. It was somebody I met through the work I was doing of developing my business, and not somebody who I'd previously known or worked with or anything like that. I think that was a real key moment. That's like a line that you cross. You're like, "Okay, this is not about my network or the people who sort of know me. My value and the skills are clear. I can clearly articulate them to somebody else, and somebody else can put the trust in me to help them deliver something." So I think that was one is that first client that's sort of outside of of anybody you knew at the moment you started your business. [00:22:00] I think the second one was really landing my first kind of big client, a company that really does a lot of technologies and they're not necessarily like a startup. They're mature. They have a lot of technology. They have a lot of process. That was, that was something that was like, "Okay, now I know that I'm starting to get into the kinds of companies that I'm envisioning helping and they are seeing the value that I can provide them back. So we're in agreement and it's starting to make sense." I think the third moment was when, so I have an analyst on my team. I also have some different suppliers and people, other consultants that I work with, so kind of distributed network plus starting to build my internal team. And the first time a client approached me to actually hire somebody, my junior consultant, from my team on a project based on something that this person did for a project that I was primarily working on. And so really starting to [00:23:00] see that some of the processes and systems and ideas I'm putting in place, that it's no longer just because of me, but now it's starting to say, it's because of the company and, and their skills that other people on my team have that, you know, knowing that I manage them and knowing their skills, they, they want to hire them and me because of them. Now I know that I'm moving beyond sort of sole openership and into-- there's a company here and we're developing a shared capability. So that sort of reinforces the vision and opens up a lot of possibilities. Lindsey Dinneen: Yeah. That is incredible. First of all, you know, congratulations because it's hard enough when you venture out on your own, but then to go ahead and have so much success and I'm sure-- you know, you have that daily grind so it's not always all sunshine and rainbows-- but to be able to grow your team and to have that moment of, "Oh my goodness, this is a company. It's not just me now, it's a company and there's other team members and we're all providing such [00:24:00] value to our clients." That is amazing. Congratulations. That is just the first step. So I'm really excited for you. Dasha Tyshlek: Thank you. Yes, me too. Lindsey Dinneen: Yeah, absolutely. Well, pivoting the conversation just for fun. Imagine you were to be offered a million dollars to teach a masterclass on anything that you want. It can be in your industry. It doesn't have to be. What would you choose to teach and why? Dasha Tyshlek: Oh, that's a tough one. I actually have a competing hobby that I would probably choose from, and that is how to set up a wonderful backyard garden that produces food and flowers for the season. I think we I think we need more backyard gardens and more gardeners. But I think I would have to spend that entire million dollars on getting people to attend. So maybe not the best choice of a million dollars, but professionally speaking, I think I would love to teach about setting up frameworks [00:25:00] for thinking about-- any kind of problem really-- but business development related problems. I think there's, there's a lot of really great frameworks out there teaching people how to use them in order to anchor your thinking and your decision making in kind of a shared understanding of priorities that requires a framework. So we could start with the frameworks that exist, but teaching people how to think outside the box and create their own framework for the situation, how to be basically their own strategy consultant in PowerPoint or on paper and help them think through problems that are complex and chaotic by creating frameworks would be, I think, really valuable to many people. I don't think it's taught very often. And certainly it's it's such a huge leg up on any kind of problem solving that you have to do to be able to kind of anchor yourself in a structure before you go and start making [00:26:00] decisions. Lindsey Dinneen: Yeah, I love that. I love that idea too, because especially something that you said really struck a chord with me about solving the idea of chaotic and overwhelming problems and creating a framework for that. There's so much of life is, I mean, life is a learning curve, right? So there's so many times where it might be very helpful to approach even a personal problem or a personal challenge that comes up with the idea of a framework where you can say, "Okay. Yes, this feels overwhelming and anxiety inducing, and whatever other big feelings you have about it that make it feel so overwhelming you can't even get started." But what if you think about it in terms of a framework and how could that help you take it out of all of the emotion, maybe, and help you transform it into, okay, this can be resolved is some creative problem solving strategy. I think that'd be amazing. Dasha Tyshlek: Yeah, and sometimes [00:27:00] when you put things in a framework, you discover that either pieces of information that you need to actually make a decision or a path forward are just missing. You put it in a framework, you're like, "Oh, of course, it makes sense, I'm missing this whole thing of information." Or, alternatively, so it can actually stimulate that aspect of creative thinking, but also it can prompt more idea generation. And, and I do find sometimes-- it's like the problem diagnosis-- sometimes if I come into a scenario where there's a lot of confusion about, "What do we do? How do we move forward? What product should we choose? What business model should we choose?" The first thing to do is to create a framework for decision making because, you go and you do the research and you get the information, you still don't know which one to do because the information by itself, you know-- unless the information's like there's zero opportunity here, but there's never information like that. The information's always that there's some pros over here, and some [00:28:00] pros over here, and some cons, and some cons. So without the framework you just drown in the amount of knowledge. Facts without a framework don't lead to a decision, they just lead to a lot of facts. So learning how to step back, when do you actually go back to a framework, and how do you create a framework for this situation, because sometimes it feels like you don't have a framework for this situation, the situation's unique. But you can then come up with your own framework, merging ideas from other frameworks, or utilizing your own creative skills to kind of draw up a structure within which you can make decisions. So. I think that would be, that would be a very fun master class. Lindsey Dinneen: It would be fun and super valuable So I'll sign up for that when you give that Well, how do you wish to be remembered after you leave this world? Dasha Tyshlek: I always focus on three areas of growth for myself. When people ask me what I want to be, I think "kinder, wiser, and more courageous" is what I want to be over time. And [00:29:00] so I would hope that, I don't know that those things have a definite end, but if I can be remembered as having worked towards that in a way that people felt in their lives, then that will be good. Lindsey Dinneen: Yeah, that's a beautiful answer and finally, what is one thing that makes you smile every time you see or think about it? Dasha Tyshlek: Flowers. I love, especially on the side of the road, when you're driving somewhere, and sometimes you see that nowadays on highways, there's been some wildflower planting. That's just so good. It's good for the environment, it's beautiful on the eyes, it's good for the bees. So, so always happy to see more flowers being planted for a more beautiful world. Lindsey Dinneen: Yeah. Oh, I love that so much. Great answer. Well, thank you so very much for joining me today, Dasha. This has been such a pleasure, and I'm just so impressed with you and [00:30:00] everything that you're bringing to the world to help these amazing companies become even more effective, and this creative problem solving that you bring to it with your frameworks and whatnot. So, I just want to say, you know, a huge kudos to you for everything that you're doing: the podcast, I hope that all of my listeners go and check hers out as well. And yeah, just thanks for being here. Dasha Tyshlek: Thank you for having me. Lindsey Dinneen: Of course. And we are so honored to be making a donation on your behalf as a thank you for your time today to the Polaris Project, which is a non governmental organization that works to combat and prevent sex and labor trafficking in North America. So thank you for choosing that organization to support. And we wish you continued success as you work to change lives for a better world. Dasha Tyshlek: Thank you very much, and thank you for that donation on my behalf. Lindsey Dinneen: Oh, yeah. And thank you also to our listeners for tuning [00:31:00] in. And if you're feeling as inspired as I am right now, we would love if you would share this episode with a colleague or two, and we will catch you next time. Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit [00:32:00] velentium.com to explore your next step in medical device development.

Meet Holly Rockweiler, CEO of Madorra. This episode explores the transformative journey of Madorra from a Stanford Biodesign fellowship project to a pioneering force in women's health aiming to revolutionize the treatment of vaginal atrophy and dryness without hormones. Holly's story is not just about groundbreaking medical devices, but also about the passion and determination that drive the quest for better healthcare solutions. Through engaging storytelling, this episode unveils the challenges and triumphs of bringing novel technologies to market, the power of female leadership in STEM, and the broader impact of MedTech on improving lives.  Guest links: www.madorra.com | https://www.linkedin.com/company/madorra-inc-/ | https://www.facebook.com/MadorraMedical | https://twitter.com/MadorraMedical Charity supported: Equal Justice Initiative Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 033 - Holly Rockweiler [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. [00:00:51] Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host Lindsey, and I'm so excited to introduce you to my guest today, Holly Rockweiler. Holly is co-founder and CEO of Madorra, a woman's health company dedicated to changing the treatment paradigm for vaginal atrophy and dryness. She co-founded Madorra as a spin out of the Stanford Biodesign fellowship, where she implemented ethnographic research to identify unmet clinical needs and define user market and product requirements for solutions and women's health, urology, and infectious disease. Prior to Biodesign, she worked as a Senior Research Scientist at Boston Scientific, where she developed therapies to enable more efficient care for patients living with heart failure. Her preclinical and clinical research has led to more than 20 pending and issued patents. Holly holds an MS and a BS in Biomedical Engineering from Washington University in St. Louis. Welcome, Holly. It's so wonderful to have you here today. Thanks so much for joining us. [00:01:49] Holly Rockweiler: Thanks for having me. [00:01:51] Lindsey Dinneen: Yeah, absolutely. Well, I was wondering if you wouldn't mind starting off by telling us a little bit about yourself and your background and maybe what led you to the medtech industry. [00:02:02] Holly Rockweiler: Sure. So let's see. So my background is in biomedical engineering. I majored in biomedical engineering. Maybe I can say why, like I, I knew that I wanted to be an engineer. I felt like, well, first of all, as a woman in math and science growing up, when I did every teacher told me to be an engineer, but I didn't really know what that meant until I got to college, but I liked it. Pursued engineering and I started undecided, but very quickly found that I was, most just excited about the problems in the biomedical engineering field. I remember one of my classes was like "calculate the torque of a drill on a tooth," I was like, "Wow, that's amazing. I think I found it." [00:02:41] So majored in biomedical engineering, got my master's and bachelor's at Wash U in St. Louis, and then I went to work for Boston Scientific. And so they are a medical device company. And so that's obviously how I got into it, but I did seek that out. When I was thinking about what did I want to do, I thought about... chemistry was never an area I felt very strongly about. I liked stuff I could hold in my hands and really conceptualize. And so I think that's what led me more in the device road and then had a incredible opportunity to work at Boston Scientific. [00:03:15] And so I worked there for several years in their implantable cardiac division. So that's pacemakers and ICDs, working in the research department. So that was also really cool because we were on the front end helping to define the next generation products and was able to also work very cross functionally. So just because research conceived of an idea didn't mean it was going to be in the product development had to help it go forward, and obviously we were keyed in very closely with the marketing team to understand. What were the needs that we were solving. [00:03:45] So it was an incredible introduction to our industry. And then I decided that I wanted to try a smaller company. There was just some broader themes of working in a large company that didn't totally jive for me. And so I was like, "Well, I don't know the first thing about startups." So I had heard about the Stanford Biodesign program, which is where I went next. And the company that I started, Madorra, is a spin out of that program. [00:04:14] Lindsey Dinneen: Wow. Okay, so your path is really cool, and I love that you are an engineer, and I love your passion behind it too, just hearing you talk about that one random problem and your excitement about it. I adore that. I do. Because that is not my leaning. So whenever I hear somebody just get really excited about that kind of thing, I'm like, "Yes, tell me more." [00:04:40] Holly Rockweiler: Well, then you're in the right field too, I would say. [00:04:42] Lindsey Dinneen: Indeed. Indeed. Indeed. So, yeah. I'm just curious. Okay. So, so going back just a little bit, you started off at Boston Scientific and kind of developed this appreciation for the medical device space and innovation. And then with Stanford Biodesign, can you tell me a little bit about being a part of that and then how you were able to spin off into your own company? I mean, that's not, that's like a one sentence thing that you put in there, but I know that it took a lot of work, and I'd just love to hear about that process, and your experience. [00:05:17] Holly Rockweiler: So, absolutely. So, the Stanford Biodesign program has many different facets. I was part of the fellowship, but they also have classes they teach and books and online resources. And then other universities have kind of sister programs around the world, frankly. So I was very interested in joining the program, like I said, to kind of-- what I was telling myself was like a way to dip my toe in the water of what a smaller company would be like. Now that's not at all what Stanford pitches the biodesign program as. Really what it is a an academic training program for an innovation process. And that's what they teach you. Now there are a lot of companies that end up spinning out of it. [00:05:56] And so I thought, "Well, maybe, like I said, this is a way to dip my toe in the water, but also if I decided to come back to a larger company setting, this skill set still would be highly useful given what I want to do in my career. So that's what I set out to do. And so the program I love, I think is fantastic. It's as described initially, it's this innovation process and they teach you that in a very hands on way. So first you start with really understanding and building a list of unmet needs, and so that starts by looking for problems in Stanford Hospital. You kind of have this unfettered access as an engineer. It was the 1st time I had that, you know, observe and ask questions and talk to physicians and patients and other health care professionals and then. you end up with, obviously, a long list of problems that you can find, just like any, anywhere in the world, right? This could happen. But also this, in healthcare, it happens. [00:06:55] And then you translate those problems into what the program calls need statements, to really-- there's a lot packed into that, but once you have those, then you spend the bulk of the program actually learning how to filter that long list of problems down into a couple key top unmet needs that you're working on. And so again, this is their goal is academic. They want to teach them their product is the people. They want to teach people this process and have them go out and share this process and use it to be successful in whatever, you know, vein they end up going down. [00:07:32] And so I was like, I was just having a conversation with my husband this weekend. I was like, we were talking about something interpersonal and I said, "Well, the unmet need here really is..." So it certainly has, you know, I've drank the Kool Aid completely and love to share it. So, but anyways, so, but what happens because you're working hands on these projects you very often, which was the case for myself and my co founders, by the end of the year, you may have something that you're pretty passionate about. [00:08:00] And so what has now become my about me description is working in women's health. I had no idea how passionate I would be about. I feel like I kind of backed my way into it, but now kind of reviewing that history, it's like, "Oh, maybe I was always kind of destined for this given my interest in, in, you know, activism." So kind of combining all of this together is what led us here. So, spinning it out was a consequence of having a lot of hard work with my team throughout the year. And we had other projects too, but this became the one that kind of survived every stage gate. And we ended up spinning out. into the company, Madorra. [00:08:42] Lindsey Dinneen: Wonderful. Well, thank you for sharing a little bit about that. And also, I love the crossover into real life, not that's not real life, but I do your daily life as well. Oh my gosh. That's great. I'm going to start doing that. Okay, so can we talk now a little bit about your company and the product that you've developed and where you're kind of looking to take it in the future? [00:09:05] Holly Rockweiler: Certainly. So, again, being born out of Stanford, we started with an unmet need around creating a treatment for vaginal dryness and atrophy for postmenopausal women that didn't rely on hormones. So this is a problem that I had never heard of before we literally met patients with this problem and talk to providers about this problem. And as we started researching, "Wow, up to 75 percent of all postmenopausal women are dealing with some, you know, degree of this. How have we not heard of this before?" That is a striking number of people. [00:09:39] And so as we continued to do our research, very quickly learned the gold standard treatment here is hormone therapy, but even though this market is huge, only 7 percent of the market is using hormones today. And so that... there's a lot of reasons why, but that's really what motivated us to say, "Wow. There needs to be another option." Because if you don't want hormones right now, the only other FDA cleared product or category for treating this are over the counter lubricants and moisturizers. And those are like, both of the products that exist today are really, those categories are really great, but they're not enough. [00:10:16] And again, with 43 million women in the United States with this problem, like we need more than just those two categories. And it really felt like no one had really looked at this. I mean, hormones, again, are a good solution for the patients who want to or can use them. But for patients who can't, for example, breast cancer survivors, they're stuck with, you know, just kind of subsisting off these over the counter products that really are not enough when your case is more moderate or severe. [00:10:43] And so we said, "Well, let's look at this and see if there's a better way or, you know, something we could combine," and ended up developing the idea for what is now the main product that we're developing at Madorra, which is a home use device that uses ultrasound to really rekindle the body's natural lubricating process. And so our whole goal has been to be very supportive of the other products in this category. We think hormones should be used more often than they are, frankly, but that women shouldn't have to make a compromise. If they don't want to use hormones, then they should have other options, and that's where we come in. [00:11:21] So our product, we will, it's not on the market yet. We're working towards that, but when it's out there, what we envision is a prescription happens from the gynecologist, and then the patient uses the product at home on a regular basis to, like I said, kind of revitalize that natural process. And what patients have told us they like about this is that It is restarting their own natural lubrication rather than some exogenous hormone or chemical. And there's less of a kind of a goop ick factor, you know, than having to use these over the counter things, which again, they like say that not to say that those don't have their place because they absolutely do, but it's not enough. [00:12:01] And so, we're pre FDA clearance, but we have a breakthrough designation from FDA. So that's feather in our cap and will help us get through the agency more expeditiously. And we have done several clinical trials and look forward. We've published one of those trials in our first manuscript, and we look forward to putting more of our data out there to help really lay the foundation to say, "Yeah, ultrasound is an appropriate approach to treating this and has virtually no side effects." So this should be a great option to be available to as many people as possible. [00:12:36] Lindsey Dinneen: Oh, that is incredible. Oh my goodness. Well, yeah, first of all, again, you know, it boggles my mind and it probably shouldn't anymore, but it continues to when you tell me statistics like this, that 75 percent of women who've are in this situation or have this concern or whatnot. And you're just think, you're addressing it in a way that's so innovative. And yet that hasn't really been addressed yet and it happens again and again with healthcare for women. And I'm wondering, you know, you mentioned earlier being very passionate about this. So I'm wondering if you can speak a little bit to fem tech and women's health and how you're involved in helping to push the conversation forward 'cause I know that can be a little challenging at times. [00:13:23] Holly Rockweiler: Absolutely. Yeah. And well, it's super fascinating too, because we spun out of Stanford in 2014. So we're coming up on 10 years here and the conversation is so different today than it was just, well, just 10 years. I mean, it was a decade, but it feels like yesterday. Like a lot has changed. When we first were starting Femtech wasn't a hashtag, like that was not a conversation. And people would say like, "Ooh, that's a niche." Yeah. And that doesn't happen anymore, which is really great. So while that's, that's certainly progress, so we should acknowledge that and be proud of everyone who's worked towards creating that progress. So I think what's been interesting, though, it's like the pace of progress, maybe? [00:14:09] So it's very exciting to know that there are, for instance, obviously I spend a lot of my time fundraising, there are women's health focused venture groups now. They, that's fantastic. That we just need bigger and bigger funds to be focused on that. We just need more and more We need more of everything, right? I mean, one of many things I've been very surprised to learn is how little training physicians get on menopause specifically. And so that has to change. And so there's just like a lot. [00:14:40] And so to the point of activism, like there's a lot to say, and so I think, it's... being raised by parents who are feminists, that helps, I think, me just start by saying, "Well, no, this shouldn't be . We can do better, and we will do better." So that's helpful, and I think that's also what really keeps me going-- obviously, every job is hard, and in our startup world, this is certainly a lot emotional rollercoaster. And so when I think about when I have harder days, it's like, "Wow." We've had patients tell us, for example, "I can't believe you're even paying attention to this. I can't believe you're listening to what I have to say." And so one, that's disturbing that's, as little as it's needed to make someone feel better. Secondly, it's "Wow, we can have such an impact by just being out there." So like the fact that we exists, I always think is helpful and that we do things like this and have open conversations about vaginal health for an aging population. [00:15:39] I will also say that, a year ago at the Super Bowl last year, there was an ad for a hot flash drug. And so that's like, you know, the world stage, menopause is being discussed. That was not happening 10 years ago. There is real progress being made. The last thing I want to say is that one thing I, I have also really appreciate about working in women's health and how supportive everyone is of everyone else. Every, anytime, even like our closest competitor, when I met their CEO, she was wonderful to me and, you know, shook my hand and said, "How can I help you?" And it's like, "Where else does that happen?" That's incredible. I think 'cause we all see there's a lot of work to be done. We can't do it alone. We want to support each other. [00:16:19] Lindsey Dinneen: Oh, I love that. Yeah, that is something that I have really admired and appreciated about the medtech industry. I think because people are curious, and their mindset is very innovation problem solving, "how can I help?" It seems like even with competitors. Yes, we're maybe vying for similar people to sell to. However, there's this idea of camaraderie, which I don't find in a lot of industries. So yeah, to your point, I think it's really helpful to have those allies in the space because that's, it's a little different. [00:16:53] Holly Rockweiler: Totally. [00:16:54] Lindsey Dinneen: Yeah. So yeah. And I, I love what you were saying about these conversations are happening more and they're becoming more mainstream and less embarrassing or taboo, which sounds hilarious because it's 50 percent of the population or whatever. But anyway, the point being, it is exciting to see this continue to move forward. And I'm wondering, even as a company, obviously your next big hurdle is getting that FDA approval, going to market and whatnot. But as you continue down the road, what other kinds of problems are you looking to solve? Or are you not even there yet? This is just like, "Let's start here. We'll get into that later." [00:17:38] Holly Rockweiler: Yeah. No, it's a great question. I think like what kind of harkening back to the just the prior question about the community of women's health. It's like you can't go a day without finding five other problems that you want to solve. So absolutely. I think that yeah, I mean, like with Madorra, we are very focused obviously on this technology and developing it, but we certainly have a roadmap of where this technology could go and other ideas of where to take it. And then what I find fascinating is that there is no menopause "brand." Like no one owns menopause, which I, if I worked at Procter and Gamble or Kimberly Clark, I would be like, hopefully 15 years ago, I would have said, "Guys, let's do it." So it's very surprising to me. So I think there's a lot of opportunities. [00:18:23] So would Madorra be that brand? I would love that. We would need a lot of other products that come together with us. So what I really see is a roll up in the future of multiple women's health products together. So I think that's exciting. In terms of, also a little bit maybe more broadly speaking, and this is no surprise to you, I'm sure, or your listeners, that reimbursement is an area that needs massive... I don't know, I was gonna say like overhauling, but that sounds pretty drastic. [00:18:53] It just needs to be clearer and cleaner and simpler. In terms of a process. I'm not saying that we should be handing out reimbursement left and right, but any investor conversation I have is, we go there immediately. And it's like, "Okay, what's the path? Well, why do you think that's going to happen?" And when, you know, X, Y, Z, other company had this happen and I can, we have a good strategy. I think I have a good pitch, but, oh, just... it just is an area that is really murky, and given that's a really critical piece in any business is how are you going to get paid? That's an area that I think there's a lot of good work being done. It just moves at a pace that is painfully slow. I don't have anything insightful to say about it except that, thank you to the people who are working on it, and I support you. I think the TCEP program is a step in the right direction, but even that has been very slow, and not without its own issues, so. [00:19:53] Lindsey Dinneen: Yeah. Still work to be done, but thankful for the work that is being done. [00:19:58] Holly Rockweiler: Well said. Yes. [00:20:00] Lindsey Dinneen: So, yeah, so, okay. So obviously, listening to you speak about your background and about the industry, it's really clear how passionate you are about this. And I, I wonder if there are any moments or series of moments that stand out to you as kind of confirming that, "Yes, I am in the right place at the right time. I'm here for a reason." [00:20:23] Holly Rockweiler: Oh, good question. Yeah. I'm trying to think like, there are plenty. There's plenty of times in the moment where it's like, "Of course, yes." And then there's like quickly like, "Oh, what's the next fire I'm trying to put out?" So it's hard to really think. I wish I had a super answer right away. I'm thinking, I guess I always come back to the patient and so like hearing-- so we've done some clinical trials in Australia and various team members of ours have gone over and been able to support the trials and be a part of them. And just hearing the stories that they bring back, it's just like, "Yes, we have to keep doing this." [00:21:01] One of our employees was there and came back with a couple stories of one of them was just like after the study visit, the patient was speaking to her and was saying, "It's a conspiracy of silence. This is a huge problem. So many of us are suffering. We're so glad you're here." And then it's other things like we did, for instance, a human factors study that was really helpful to us. And we learned a lot from, and in that study, it was like patients came in to do mock use of the device so we could improve our training materials and also, you know, all parts of the user experience. And it was amazing to me. [00:21:38] So patients, you know, participants, I should say, got zero benefit theoretically about being in that study. It was all for us to learn how to do this better. I mean, we did compensate them, but marginally, right? And so many people wanted to be in that study. And even if it was the early on patient who had-- I'm going to make it up. I had like, "Oh, the user manual didn't make sense to them" or something. They were still like, "I'm so glad to be here to help you because this product needs to be out there." And so it's like, " This is incredible. Yes!" And that part is really rewarding to me. [00:22:09] For me, it's the patients and their feedback and just their enthusiasm. And then, I was gonna say also for the healthcare providers too, we have a lot of wonderful physicians that we work with and their support has been helpful. Like for instance, as I mentioned, we put a paper out there and one of our clinical advisors was highlight, or I think a couple of them highlighted to us that like, "We need to do a second paper on a specific subset of that data because it's super valuable and hasn't been out there before," which may be the clinicians do that for everything they do 'cause they, they know the scene and they know what needs to be published, but it just felt like we have a lot of people who really are rowing in the same direction and really want to make an impact like we do. [00:22:49] Lindsey Dinneen: Oh, wow. Yeah, that's incredible. Thank you for sharing those stories. I think, you know, as you alluded to earlier, because your role has so many components, because that's the space you're in and you've got so much going on, I think it's really compelling to have something to hold onto when it gets hard and go, "You know what? I remember that patient who was so thankful just to have the opportunity to be a part of it and just wait until this gets into the hands of so many more." [00:23:15] Holly Rockweiler: Totally. [00:23:17] Lindsey Dinneen: Yeah. Yeah. Yeah. And so for you, you know, you obviously have a very strong background in engineering and innovation. How was it for you going from that to also now being an entrepreneur, and having a business, and having to also learn all of those skills as well. How was that transition? [00:23:42] Holly Rockweiler: Fun. I think that-- there's a lot of personal growth, and I've learned a lot about myself and what where I find passion. So I think there's definitely a lot of hard parts too, but what, well, one thing is that I think there's also a heavy dose of naivete that was important. I didn't know what I didn't know. And so here I am 10 years later I think, you know, in the beginning too, I was not... what do I say? I wasn't convinced, yeah, I wasn't convinced that I could be a CEO, that I should be or could be. And so I think that was, and is maybe still a definitely a continuous journey to it. So why is, why did I think that? What does that mean to me? And where am I now? That's been certainly a learning process. [00:24:31] But that's also like why I said fun, because I, I get to do such a variety of, like, I get to have this opportunity to speak to you on this podcast. I get to work with our clinical advisors on a paper. And I also get to apply for grants. And there's a lot of hard things that come with all those things, but I feel like it's been a really, I don't know, just an incredible opportunity to have a job that It requires so many different things. It also requires me to do financial modeling, which I'm terrible-- well, was terrible at-- have learned and much better at, but also don't really love doing. [00:25:04] So it teaches you what, what you might look for in a future chapter of your life as well. But I'm someone who really thrives on, I have a very curious mind. So trying new things and figuring out new things. And that, I think that curiosity is well satiated by an entrepreneur's life. The managing your own psychology is really difficult, but that's why you have a great community of people around you, both within the entrepreneur community and outside of it. [00:25:36] Lindsey Dinneen: Oh my word. I think I just need to take what you just said those last couple of sentences and just make it into a quote because that was so well articulated. [00:25:45] Holly Rockweiler: Oh, thank you. [00:25:47] Lindsey Dinneen: I cannot think of a better way to describe that journey. So thank you for, but also thank you for being vulnerable and willing to share that, because it is such a journey and it is a learning curve, but kudos to you for embracing it with an attitude of fun, like, "Let's just learn something new and it might not go great the first time, but that's okay. I'll try again." [00:26:10] Holly Rockweiler: Yeah, I was thinking, I was like, "Well, if any of my investors are listening, I have gotten really good at a lot of these things, so y'all don't need to worry." But I do think that's maybe the blessing and the curse of being a first time entrepreneur. So I think, you know, there's certainly a lot of benefits for having done it before and knowing exactly what to expect. But I think with anything in maybe any regulated industry, or maybe any startup, really, there's always going to be curveballs. So that keeps you excited. [00:26:41] Lindsey Dinneen: it's never boring. It keeps you on your toes. There's at least that. [00:26:45] Holly Rockweiler: Yes, absolutely. [00:26:47] Lindsey Dinneen: Excellent. Pivoting the conversation just for fun. Imagine that you were to be offered a million dollars to teach a masterclass on anything you want. It can be within your industry, but it doesn't have to be. What would you choose to teach and why? [00:27:04] Holly Rockweiler: Oh, that's interesting too. And that's a nice paycheck. [00:27:08] Lindsey Dinneen: Right? I [00:27:10] Holly Rockweiler: Let's see. It's getting right to what do I think I'm good enough at to teach a class about. So, I mean, I think one thing that I've been thinking about a lot recently is scientific communication and how, how different voices get amplified and how the kind of stereotypical scientific persona is, it's not the one that wants to be necessarily on social media with a gazillion followers and all these TikTok videos. So I think that I would like to teach the class in concert with, I have a lot of ideas of like, who would be a great way, who would be great people to collaborate with in order to teach or really to help promote more scientific discourse in a conversation that's appropriate and approachable for anyone. [00:28:04] I think that obviously our country has faced a lot of division and I don't think that's really true. I think that a lot of that is-- well, there certainly is a lot of division. I don't mean that. I just mean that I think there's a path to human connection via communication and that, wouldn't it be cool if we could help bridge conversations. And obviously I'm, I am a scientist. I think of myself as a scientist, so I want to think about ways to provide other voices out there to be amplified as well, or perhaps amplify the right voices to help promote just a more enriched dialogue than what is often presented as the country's dialogue today. [00:28:48] Lindsey Dinneen: I love that. [00:28:50] Holly Rockweiler: It's kind of rambling. I can get back to you with my course description, but that's probably where I would go. [00:28:56] Lindsey Dinneen: Syllabi due Tuesday. No, I think that is absolutely incredible. And I love that because I think that is something that's missing and there's some translation error that occurs. And one of the things that I'm passionate about is helping to bridge that gap between-- so I'm right on board with you-- but to bridge that gap between maybe taking some what are traditionally considered complex ideas, concepts, whatever, and distilling it down to a more accessible format. And because everyone learns differently, it's just helpful to have a wider range of options. [00:29:35] Holly Rockweiler: Totally. [00:29:36] Lindsey Dinneen: So I love what you would be passionate about sharing. I mean, I would sign up for that masterclass. [00:29:41] Holly Rockweiler: You can help me teach it, I think. [00:29:43] Lindsey Dinneen: Okay. Deal. We'll get back on that. [00:29:45] Holly Rockweiler: Okay. [00:29:47] Lindsey Dinneen: Excellent. Yeah. How would you wish to be remembered after you leave this world? [00:29:53] Holly Rockweiler: You have some great questions. Yeah, let's see. You know, I've honestly never thought about that. I think that I would, what would I want people... well, I think about like what I would want my friends to think. That, like, they were loved and that they hopefully shared that love broadly. But then, well, let's see, that's not really, like, remembering. Yeah, I guess, maybe it is. So, yeah. That I'm a lover, a curious person, and that I, there is a lot of beauty in the everyday, and so there's a lot to be excited about even on the hard days, [00:30:32] Lindsey Dinneen: Yeah. I love that. And then, final question. What is one thing that makes you smile every time you see or think about it? [00:30:41] Holly Rockweiler: Certainly my family. I have a four year old son and he is, keeps me very present and cracks me up continuously. And so, my husband and I are very lucky to have him. And obviously my husband makes me laugh. A lot. And so I really appreciate them. And so even when, you know, the work day is hard, I feel really fortunate to have a very rich personal life outside of that. So my family and then my friends also. [00:31:09] Lindsey Dinneen: Oh, yes. Of course. That's wonderful. And I'm so glad you have that amazing support system to bring that smile to your face, especially on the tough days. [00:31:19] Holly Rockweiler: Absolutely. [00:31:20] Lindsey Dinneen: Well, Holly, this has been a wonderful conversation. I'm so thankful for you and what you're doing in this space and the fact that you're tackling an issue that affects so many people, and that you're just bringing all this innovation to, and you're so passionate about sharing that in a way that resonates with people. So I just want to first say, you know, thank you so much for the work that you're doing. I know it's not easy and there are probably days where you, you just kind of want to, you know, toss something in the trash, but honestly, thank you for continuing to do the work you're doing. It's not nothing. And I want to appreciate that. [00:31:59] Holly Rockweiler: Well, that is very kind. Thank you. And that means a lot. And thank you for doing what you're doing, too, to give people like me a chance to share, and also us to listen to others sharing their stories. And for asking, I will say, asking questions that are more about me as a whole person too. I think that when I've been in other conversations sometimes are really-- and there's nothing wrong with those, but it's fun to have, we can ask these questions. I'm like, "Wow, I would do some thinking this weekend about how I want to be remembered" because I've never thought about that. [00:32:30] Lindsey Dinneen: Yeah. There you go. I love it. Well, and we are so honored to be making a donation on your behalf as a thank you for your time today to the Equal Justice Initiative, which provides legal representation to prisoners who may have been wrongly convicted of crimes, poor prisoners without effective representation, and others who may have been denied a fair trial. So thank you for choosing that organization to support, and we just wish you continued success as you work to change lives for a better world. [00:32:59] Holly Rockweiler: Well, thank you. It's been a pleasure. Thank you. [00:33:03] Lindsey Dinneen: Me too. And thank you so much for our listeners for tuning in. And if you're feeling as inspired as I am right now, I would love if you would share this episode with a colleague or two, and we will catch you next time. [00:33:16] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Mark Oreschnick, a MedTech industry leader and the founder of Evolve Engineering, shares his journey of nearly 30 years in engineering and leadership, starting in aerospace before landing in the medical device industry. With a passion for mentoring and helping startups, Mark discusses the importance of right-sizing staff and systems for success. This conversation not only showcases the human side of technology, but also highlights the power of networking and building relationships for personal and professional growth. Guest links: https://www.linkedin.com/in/mark-oreschnick-82367a8/ | marko@evolve-engr.com | www.evolve-engr.com | https://www.linkedin.com/groups/14248328/ Charity supported: Feeding America Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 032 - Mark Oreschnick [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. [00:00:50] Welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey and I am so excited to introduce you to my guest today, Mark Oreschnick. Mark is the founder, owner, and president of Evolve Engineering, LLC. With over 25 years working in and leading engineering and operations in small, such as four employees, to large, such as 15,000 plus employees, companies, he has gained valuable experience he will use to complete your project as efficiently as possible. Mark's career has focused on developing products, processes, people, and businesses. Mark, thank you so much for being here. I cannot wait to talk with you all about what you're doing and your background. So thanks for joining today. [00:01:36] Mark Oreschnick: Thank you. I'm happy to be here. [00:01:39] Lindsey Dinneen: Wonderful. Well, I would love if you wouldn't mind starting off by sharing just a little bit about yourself and your background and maybe what led you to MedTech. [00:01:47] Mark Oreschnick: Okay. I've been an engineer and leader for nearly 30 years. I started in the aerospace industry in college, and while I was an intern, I was offered a full time position to work as an engineer for my last year of college. So I did full time school and work, which I think very much set me up for my life in startups because I was sleeping about two and a half hours a night. [00:02:15] Lindsey Dinneen: Oh my word. [00:02:16] Mark Oreschnick: So, after that, I just kept having bosses challenge me with a variety of different projects. I've designed and built buildings for two different companies, automated. Equipment doing 16 million packages in four months, shipping out of a company, totally different industry and 20 years ago, coming this Valentine's day, I started the medical device industry. So, I'm coming out of my 20th anniversary right now. And within the medical device industry, I've been in really large and really small companies, both on the operations and manufacturing side and the R&D side. And I'm currently working with my seventh startup. So that's, like I said, the world of startups I've really enjoyed. [00:03:02] And now I've moved into consulting full time, and I'm working with startups as a fractional CTO. So I'll put together their technology roadmap, help build their R&D team, work with the founder on what I've learned from my experience. What are the good things to do? What are the bad things to do? And how to right size your staff and your systems to be successful. [00:03:26] Lindsey Dinneen: Oh, that's incredible. Well, thank you for sharing about that. It's so much fun to see how little bits of threads throughout your career kind of interweave, and then all of a sudden they've produced this really cool thing. And that's now you doing this on your own and consulting. And I just love hearing about that. Several things just stood out to me and I'm curious. Okay. So, so you said you sort of set yourself up for success by being like full time college student, full time working at the same time. And then yes-- so can you start by: where did this drive in this passion come from, because clearly your work ethic is astronomical and wonderful, so maybe start there. [00:04:11] Mark Oreschnick: I would say it comes from my parents. Definitely did not grow up on the rich side. So everything that we had in our lives, we worked hard for. And I learned that if I wanted something, I needed to go out and get it. So, I think that was a good attitude that my parents put into me. And then they also, I won't say over expected things from us, but it was more, if you say you're going to do it, you're going to do it, figure out how to get it done. Just live up to what you say you're going to do. And that I think automatically put a drive behind me to just, all right, and you offered me a full time job. I'll be successful at it, but I'm graduating. So I got to be successful there and I'll just figure out how to make it happen. [00:04:59] Lindsey Dinneen: Yeah. Yeah. And then you alluded to the two and a half hours of sleep a night. I hope that's still not the case moving forward. [00:05:08] Mark Oreschnick: No, it's better than that now, but I've had 24 hour days as things come up throughout a career, and it's, you do what you need to at that point for your company and to get things done or you're having a team work extra hard. You get in there, you work with them, make sure that they're getting the support they need and they know you're there for them. So, sometimes it's insane. Other times you get to relax a little bit, but that's also, like I said, the life of a startup, you have your big pushes and then you get to relax for a little while and then you hit your next push. [00:05:47] Lindsey Dinneen: Yeah, so true. It seems like you have quite a passion for helping startups in particular, and you obviously also have your own entrepreneurial bent and endeavors. And so where did the interest in helping startups in particular come about? Because I know that's a, can be a different skillset in terms of you often wear a lot of different hats and you end up pitching in so many different ways. So, so tell me about your heart with startups and entrepreneurship. [00:06:17] Mark Oreschnick: Someone who has now become one of my best friends, we, my very first medical device job, I worked with him and when I left to go to another company, we looked for a position for him to join me. There wasn't a good fit, but a couple of years later, he went to a startup, which he had already been in startups previously, and asked me to come over and work with him there. And I came in, I saw that I could do a lot of things to help people. And that's kind of been my career also is how can I help people do things easier, better, just make their life easier. So if I saw a gap where there wasn't someone to jump in, I just jumped in and filled it. And that's what you do in a startup and it just really worked with my attitude of, I get to help a lot of people because, today I'll work on documentation with the quality side, next week I'll go build a fixture for production and whatever was needed at that moment. It let me get that joy of helping people. [00:07:23] Lindsey Dinneen: Oh [00:07:23] Mark Oreschnick: And that's ... If you get joy out of everything you do in work, it makes going to work really nice. [00:07:29] Lindsey Dinneen: That is so true. I love that. That is so true. And so, you know, then you also have the skill sets to be able to help in lots and lots of different ways. And one common theme as I've been doing some of these interviews is that it seems like having that generalist background-- I mean, obviously you're highly specialized as an engineer. You're incredibly incredibly gifted and talented in that way. And you've built that skillset, but then you also have the opportunity to draw from multiple different industries that you've been a part of. So how has those various other kinds of influences in your life maybe contributed to your success now? [00:08:13] Mark Oreschnick: I would say one of the ways that definitely benefited me a lot was getting into a non technical industry. The industry where I did the packaging automation and built my first building is called Consumer Fulfillment. Literally at that time, you were getting in buckets of mail, manually sorting it, data entering information into a computer, typing in UPC codes, like not technical, not anything like that. But it made me look at that world in a big picture format. And how could I help the process and make things flow from department to department much easier. And I just had to step back and kind of, all right. By making this process easier, I'm helping on the finance side. By making this less labor intensive, we have less workman comp. [00:09:14] And it was just, what affects each piece of it? And as you kept digging deeper and deeper, you got to learn what the IT group did and how they could change the software to make it better. You'd figure out what the shipping companies are doing. We actually figured out how to load semis and make sure that the addresses were in the order of the post offices that they were going to. So the last bag onto the mail truck was the first bag that they took off. And we built that into our computer system so the trucks could drive direct and never have to backtrack or unload extra things. So it's just, you have to start looking at that big picture and you got to learn about every department to see how they all work together and make sure everyone's efficient, not just your little group. [00:10:05] Lindsey Dinneen: Yeah. Well, and I love that approach. Being able to look beyond maybe what you feel like is the daily task or the task most important at hand and have that zoomed out view of, okay, this isn't just important for the success of this one department. It affects everybody else. And I love that. So now in your current role and in your current business with Evolve Engineering, you get to have that more eagle eye perspective again. Is that true? So when you're coming in, you're able to help? [00:10:36] Mark Oreschnick: At the beginning, yes, if it's a new founder, and there tend to be two new founders that I've met lots of. They've, almost all of them have never been in a startup before. So that's a common theme. And they either come from not within the medical device industry or from a very large company within the medical device industry. So changing the mindset and getting real expectations and real realistic goals and budgets is where you kind of start with that. So I work with them to talk about, here's how much you can expect to spend on this project. Here's how long it's really going to take. [00:11:21] If you're from a big company and you're still having five different computer systems that are managing your inventory and your sales and everything else, we're going to be running on QuickBooks and Excel, and that's what we're going to live by. Because if you want to put those systems in, you're going to hire 20 people to manage those systems rather than 10 people to get the product out the door. And get this design finished. So it's teaching them to just have a total different mindset about everything. And still knowing how all those systems have to work together. But trying to get it down onto the micro, basic scale, rather than going on to buying a great enterprise system, but we're not actually going to sell anything for five years, so we don't really need it. [00:12:15] Lindsey Dinneen: Yes. Yeah. Yeah. Thank you for sharing a little bit about the two different types of these startup leaders that you're encountering. And I'm wondering, so part of your role, it sounds like, is not just getting into the very specific nitty gritty details of the actual company operations and technology and whatnot, but it's also having a little bit of this even broader range of, how do I help you as the leader develop the skills and priorities that you need to. So it sounds like you're in a, you're in a very Diverse mentorship kind of role in addition to like, let's get down to the nitty gritties, but you're also helping them develop those skill sets. Yeah? [00:13:00] Mark Oreschnick: Yep. That's my goal is to help them become a good leader of a startup and understand what it takes. And I met with a doctor who had found me on LinkedIn about his company. And I wasn't sure exactly what he wanted, but as we were talking through things, I told him, "if you plan on being the CEO, we are going to figure out what day you fire yourself from that position." I said, we will do it to save money in the beginning, but you're a doctor. Be a doctor. Let's bring in a professional CEO when we get to the point where you stop saving the company money and possibly cost us money." And, he didn't want to be the CEO. [00:13:43] So it wasn't a conversation that had to be had, but trying to put the mindset of, you're a great inventor, kick me out of my job, become the company CTO, drive development once we get to that point. I'm totally fine with that because it's the best for the company and it'll get us to the sale of the company or commercialization spending the least amount of money and getting there as quickly as we can. So being part of it's, be open, have those conversations with people and do that type of mentorship in the beginning. And if somebody said, "no, I'm going to run this thing until the end, I'm going to be the greatest CEO." I probably know from the beginning, I'm not the one to work with them. [00:14:29] Lindsey Dinneen: Sure. Yeah. [00:14:33] Mark Oreschnick: We probably won't gel in the end. [00:14:36] Lindsey Dinneen: Yeah. And do you find that it's partly because perhaps the idea of, the things that got you to where you are not the same skill sets that are going to get you to the next level? Is it partially just because usually that somebody who comes up with this great idea and has the passion and the vision for the company can really get it off the ground and maybe get those first rounds of investment, but then they might not possess the skill sets to get them to continue growing and scaling. Is that part of it? [00:15:10] Mark Oreschnick: That's 100%. [00:15:11] Lindsey Dinneen: Okay. [00:15:12] Mark Oreschnick: What normally it is and truly that passion in the beginning as the CEO gets your team driven. You get a lot done. It is a wonderful thing. But once you start to look at the commercialization and how do you grow a business, that creativity and passion don't directly translate. Now it's getting into nuts and bolts, black and white, a little more ruthless and you have to do what's right to make the company commercial. [00:15:43] And the, I think it's lots of times not even ego of the founder. It's the passion. It's their baby, and they don't want to give up control and worry that somebody is going to ruin it. But that's why if you move yourself out, but stay within the leadership role in a different way, you're hand in hand with the CEO and you can move the company forward together rather than having a board kick you out because you're not doing your job and then you've lost all connection to your company. [00:16:20] Lindsey Dinneen: Right. [00:16:21] Mark Oreschnick: So I look at it as a, here's a way you can grow and you can learn from that CEO so the next time you do this, maybe you are the person who can take it another step, bring in the new CEO, one step farther down and finally you'll get to be that person who runs the company from start to finish, but you got to learn it. You got to live through it and protect your baby by moving into a different seat. [00:16:46] Lindsey Dinneen: Oh my goodness. Yeah. What a challenging thing to overcome. So it's helpful that's your perspective from the start so you can help people prepare for that and that this is actually a wonderful thing. It's a growth thing. It's not a demotion. It is not a, you are any less important. You aren't. You're as still as important, but you're just moving into a role that suits you and suits what the company needs. Yeah. That's really interesting. [00:17:13] Mark Oreschnick: And there are some investors who, if they hear that day one, that you know you're the one to bring it up to a certain point and then you will transfer it that will give them more faith in you because they know that you understand where your skills are and that you need the commercialization person to move the company to sale and they're going to appreciate that. [00:17:37] Lindsey Dinneen: Yeah. Yeah. And so with your consultancy now, can you tell me a little bit about how that came about? And then I'd also love to hear, because I know that you've started, or co-founded, a very successful networking group in Medical Alley. And I would love, if you wouldn't mind sharing just a little bit about that, because that's a really cool opportunity for people in the area. But I would just love to hear a little bit about your origin story as well. [00:18:04] Mark Oreschnick: So my origin actually started about eight years ago. [00:18:07] Lindsey Dinneen: Aha. [00:18:09] Mark Oreschnick: And the gentleman that I talked about who brought me into my first startup, we were at two different startups and he asked me if I could do a side project for him for his company to help it out. So I started Evolve Engineering. [00:18:24] Lindsey Dinneen: Okay. [00:18:25] Mark Oreschnick: And they brought me into interview to see if I was the right guy to do this project for them. And they liked my overall skill set and offered me a permanent position. So I wound up not consulting. [00:18:39] Lindsey Dinneen: Sure. [00:18:40] Mark Oreschnick: But it was something that I'd always thought, yeah, someday I'll get into this because one of the things great about startups is doing lots of short term projects. Even if your company lasts for seven years that you're there, you've jumped around a lot in it because that's what the company needed. So the idea of consulting and knowing that I'm going to be jumping around is exciting because you're always doing something new. So that got me hooked. [00:19:07] Lindsey Dinneen: Yeah. Yeah. [00:19:09] Mark Oreschnick: And then I was with a startup and I was looking for, what do I want to do next. I knew it was time to be moving out of that startup. And I started researching consulting and got myself connected with a bunch of people. And then another company offered me a permanent position. [00:19:27] Lindsey Dinneen: Okay. [00:19:29] Mark Oreschnick: So that postponed me for about another 16 months. And then in late 2022, I made the decision that "No, it's really my passion. I want to get back helping as many startups as I can." And I just dove into it. One of my former employees became my first client. And then another group called me up of a bunch of employees that I used to work with at a different startup, and I started working with them. And then, like I'd mentioned, a doctor called me up, so I have a deal going with that company. And it's all these little pieces just coming together. And right now, I have two different companies that are submitting me for projects that they're just waiting on funding for. And someone that I connected with through this networking group. He called me up and said, "Hey Mark, in, in February, I'm going to need your help on one of my projects." So he used to be the founder of a startup. Now he's doing the exact same thing I'm doing and he's my competitor. And he called me up and said, "I want you to work with me." [00:20:37] Lindsey Dinneen: Phenomenal. [00:20:39] Mark Oreschnick: Yeah, it's good competition and those are the people that I still have around me are people I've worked with in the past or met in the past. We don't look at each other as competitors. It's, "You're going to be better at this one than me. So you take it and you'll tell me about one that I'm better at than you." So, so that's got me kind of up to today. And you had mentioned my networking group, which is called The Twin Cities Medical Device Networking Group. I was in a group pre COVID that actually died before COVID. So COVID wasn't the killer, but it made starting a new networking group a real challenge during COVID. I tried bringing the old group back. We had one event and then a new spike, and it died again. [00:21:32] Lindsey Dinneen: Yeah. [00:21:33] Mark Oreschnick: So working with one of the startup accelerators that I'm involved with, I went to a medical presentation that they were having a showcase about all of their startups that they were working with, and met a gentleman named Kris Bauerschmidt. And he and I actually already had a call scheduled for the next day through a different networking group and we just happened to run into each other in person. So we started off, we did the call the next day, and I toured his company a couple weeks later. And I brought up, "Hey, I'm thinking about starting a networking group." And he said, "Oh, I'd love to be a part of that, can I help you?" And that was on Thursday, so April 29th, which was a Saturday, I started the group. And it took about 16 days to get up to 100 people. [00:22:24] Lindsey Dinneen: Wow. [00:22:26] Mark Oreschnick: About another month to get to 200. And then it started slowing down a little bit. So now we're at eight and a half months since we started it, and we have almost 850 people. [00:22:38] Lindsey Dinneen: Wow. [00:22:39] Mark Oreschnick: So it's growing basically a hundred a month. [00:22:42] Lindsey Dinneen: That's amazing. Congrats. [00:22:45] Mark Oreschnick: So each month we just post on LinkedIn, "Hey, we're doing a happy hour at this brewery." People come out, get together. We normally have around 70 people show up to each of our events and people sit around and you talk a little bit of business, you know, "Hey, what do you do for a living? What cool projects are you working on?" that type of stuff. And many of these people have now got to the point of, "So how's your son's basketball game last night?" And we've become friends and we're building relationships. Business is going to come out of that naturally because now we've actually built trust in 70 other people that we meet, and really it's probably about 150 people rotate through our events, but there's always around 70 that show up. So this 150 out of 850 is getting to be a tighter network every month. [00:23:40] Lindsey Dinneen: That's incredible. [00:23:42] Mark Oreschnick: And out of that, we wound up doing a presentation at startup week, Kris and I, for other people, we did a panel discussion on Networking 101. [00:23:50] Lindsey Dinneen: Nice. [00:23:52] Mark Oreschnick: A college brought out their entrepreneur program and we had 20 plus students from that, and it was a total of, like, 80 people showed up to hear us talking about networking. [00:24:03] Lindsey Dinneen: Nice. [00:24:04] Mark Oreschnick: And that's one of the keys in the med device industry, or actually in any industry, network, know the people you're working with. If you ever get laid off, fired, you're in transition, you instantly have a group of people to go talk to. But the big thing that we've seen in our group, lots of the people are there really just to help. [00:24:26] Lindsey Dinneen: Yeah. [00:24:27] Mark Oreschnick: Much less about, "What can I get out of this," and it's, "What can I do for you?" So, it's really nice that, you know, people are saying, "Hey, let me introduce you to this recruiter. Hey, let me introduce you to this person. They might be able to help with your project." And it's much more of the giving side of things. And it gets kind of funny when you have two people who are both givers, who have are meeting for the first time and trying to talk about something, and both of them are trying to give and neither wants to receive. [00:24:59] Lindsey Dinneen: Yes. [00:24:59] Mark Oreschnick: So eventually somebody has to just step out of the zone that they're in and say, "This person's honest and trying to be helpful. I need to accept that." [00:25:10] Lindsey Dinneen: Yeah. [00:25:11] Mark Oreschnick: It's quite funny when you start to see these interactions of people who really network on a regular basis and are out there just to meet and help people. [00:25:21] Lindsey Dinneen: Yeah, that's incredible. And I love that. I love that that's the spirit of the group because I think a lot of times where networking groups can get challenging is it seems to be kind of the opposite. And it's sort of "what can I get from this group" versus "how can I give and contribute," but that's, that's such a part of who you are. In fact, you've recommended a couple of books to me that I have thoroughly enjoyed. And I wonder if you wouldn't mind telling a little bit about maybe how that philosophy has impacted even your own life and the way that you've approached your entrepreneurial endeavors and your networking endeavors. Would you like to share about that? [00:26:02] Mark Oreschnick: Sure. So, similar to the words that I was just saying. [00:26:06] Lindsey Dinneen: Yup. [00:26:07] Mark Oreschnick: I know the book she's talking about right off the bat and that is " The Go Giver" and it's tells the story of how somebody is out there trying to get sales and bugging everyone trying to get leads, trying to just close the deal, worrying about the end of the quarter. And eventually he meets a series of people who talk about being in things for the right reason, and you can't sell something to someone, someone has to want to buy from you. So you have to give them value, and then they will choose to purchase from you, because you cannot force a sale. You can't make somebody sign on that dotted line. [00:26:54] Lindsey Dinneen: Yeah. [00:26:56] Mark Oreschnick: So it's all about: connect with people, meet them, figure out how you can help them. Karma's going to come back, help you in the end. And I have definitely seen that in my career, you know, like I'd mentioned earlier, somebody who is a direct competitor of me calling me up and saying, "I want you to work on my project." I was trying to help him find investors at his last company. And I didn't have any stake in the game in that, but he seemed like a really good person doing a good thing. So I wanted to help him. [00:27:30] Lindsey Dinneen: Yeah! [00:27:30] Mark Oreschnick: The thing that for me about "The Go-Giver," I read it and I went, "Okay, this reinforces what I've been doing. And here's a few ways I can do it a little bit better and a little more intentionally." So I highly recommend, read the book. The guy who I founded the networking group with, I gave him a copy. He absolutely loved it. He now recommends it out on LinkedIn. The author wound up seeing that we had been recommending it to people and connected with us and commented. So, and I'm actually in another group that has about 230 people, and the first time you meet with the founders of that group, they're going to say, "You need to go by "The Go Giver" and read it." So right off the bat, that's just their first conversation. It's kind of, "If you go forward with this attitude, your business will be successful." [00:28:22] Lindsey Dinneen: Yeah. [00:28:22] Mark Oreschnick: And then the other book, it's from the same authors and it's called, I believe, it's "The Go Giver Guide to Marriage." [00:28:28] Lindsey Dinneen: Huh. [00:28:29] Mark Oreschnick: And I actually read it while I was on my 10th anniversary with my wife in Napa. And it was again about intention. You can tell your spouse that you love them, you can tell them they're beautiful, all these things, but why are you doing that and making sure you do it with reason and not just because I should say I love you every time I walk out the door. [00:28:53] Lindsey Dinneen: Yeah. Right. [00:28:55] Mark Oreschnick: And there are lots of really good tips in it that is just kind of, okay, I'm doing things good, but I can do it better. Here's a way to do it better. And it's the reminder of why you're in your relationship, why you love the other person. And it was a fun book to read. And the fact that I chose to do it on our anniversary weekend was a really good thing. [00:29:15] Lindsey Dinneen: Nice. [00:29:17] Mark Oreschnick: It was the right time to reinforce everything. [00:29:19] Lindsey Dinneen: There you go, folks. Life and business advice all wrapped up into one. It is a great series of books. I recently finished "The Go Giver Leader" too and that's another brilliant book. I was listening to it on audio book and I kept having to rewind so that I could take notes because I was like, there are too many amazing quotable quotes in this book. It's, [00:29:43] Mark Oreschnick: Yes. [00:29:43] Lindsey Dinneen: Highly recommend. Yeah. So just out of curiosity, looking back over your life, do you think six year old Mark could have ever imagined being where you are now? Or is this engineering and business and creativity? Has this always been a thread of your life or has this evolved over time? [00:30:07] Mark Oreschnick: So engineering and creativity, yes. The business side, no. If you would have asked six year old Mark, what he was going to be doing, I actually know the answer from my parents and I was going to be a garbage man. [00:30:20] Lindsey Dinneen: Yes! Coolest job ever! You get to hang on! [00:30:25] Mark Oreschnick: I love trucks. I loved big equipment and that part of me has never changed. I am a mechanic. I have two cars in my garage, one up on the lift, one underneath it. I'm always working on something mechanical. And that mechanical side of me, along with the creative side of me has helped me design different devices and keep that vision. And I know how things work on the inside, and now I can design something because I know the different pieces, and I can put them to use for a different reason. So one of my products was an upper arm orthotic that helped people eat and drink and do activities of daily living when they had upper limb weakness from muscular dystrophy. So I was able to watch a lady who couldn't put her, push her glasses up. She put our device on and held a bottle of water for three minutes. [00:31:19] Lindsey Dinneen: Oh. [00:31:19] Mark Oreschnick: Another lady went back to painting. [00:31:22] Lindsey Dinneen: Oh. [00:31:24] Mark Oreschnick: And she hadn't painted in five years since her injury. So, but it was a completely mechanical nut and bolt type system, my side of it that I worked on, and my brain just knew how to make that stuff work. [00:31:38] Lindsey Dinneen: Yeah. I love it! [00:31:41] Mark Oreschnick: That's from when I was a little kid building with Legos and working on lawn mowers and mini bikes, and it's never stopped. [00:31:49] Lindsey Dinneen: Yeah. Sure. [00:31:52] Mark Oreschnick: The business side of things, I think it still fits with my analytical brain and, you know, you can have things in columns, things have a right way of doing it. There's a process to everything that just, so that aspect of it fits me, but no, I would have never thought of that when I was a kid. [00:32:10] Lindsey Dinneen: Sure. [00:32:10] Mark Oreschnick: It doesn't sound like fun to a six year old. [00:32:13] Lindsey Dinneen: Okay. Well, I have to nerd out for just a minute because as a, I think I was maybe a little older than six years old, but for one of my early birthdays, it would have had to have been like seven or eight, or actually for Christmas, I asked for a bunch of office supplies, because I am that nerd and so I was like setting myself up to play office ever since I was six or seven. And I would have, I had my little fake phone and my little fake receipt thing. I, it was a blast. So yeah, I, I... [00:32:48] Mark Oreschnick: And your organization skills have led through to this day. [00:32:52] Lindsey Dinneen: I know. Yeah. Yeah. All the hard play worked out in the end. It's really paid off. So anyway, you've actually shared a couple of very touching moments, even those last two stories that you shared were really sweet. And I'm wondering if there are any moments like those that kind of stand out to you as reinforcing the idea that, "Hey, you're in the right industry doing the right thing at the right time." [00:33:18] Mark Oreschnick: Yeah, they're definitely, I remember the first time that I had that moment. I had always thought once I got into medical device that I was in the right field. It fit me really well. It worked with how my brain worked. We have to do all these steps to prove everything because it's a human. We need to do the right stuff because we're dealing with people and we want to save lives, not hurt lives. But the first startup that I was in, we had a whole bunch of patient videos of interviews of patients that had used our, had our device used on them and how it affected their life. [00:33:54] And the one that I always remember, there was an older gentleman who had bad circulation in his leg and a doctor told him he needed to have a below knee amputation. And he was going to be in a wheelchair for the rest of his life. Luckily he didn't like his diagnosis and he got referred to a doctor who is using our product, and the doctor was able to go in and clear out the blockages in this gentleman's leg and get blood flowing to his foot again. So all of his sores healed, all of the swelling went away. His foot became normal again. And in a very short period of time, he went out, and golfed nine holes, pulling his bag. He walked for nine holes. [00:34:44] Lindsey Dinneen: Oh. [00:34:44] Mark Oreschnick: So he went from, "I'm going to have my leg chopped off and be in a wheelchair" to going back to the sport that he loved. And being able to actually walk, not even have to ride a cart. [00:34:56] Lindsey Dinneen: Wow. [00:34:57] Mark Oreschnick: That was that moment that's kind of, "Yep, I'm where I belong." [00:35:02] Lindsey Dinneen: Yeah. Oh my goodness. Thank you so much for sharing that. That's a powerful story and what an amazing testament to the power of medtech and being able to be a part, even play a small part, in those developments and realize that you're impacting lives. Like there's, you hear these incredible stories of, you know, even if it's just one person, which it never just is, but even if it's just one person, you change their life. That's incredible. Yeah, nothing more rewarding. [00:35:36] Mark Oreschnick: Yeah, I said, that story, I'm never going to forget. I can still picture the guy and this is 14, 15 years ago. So. [00:35:46] Lindsey Dinneen: I love that. Well, so, so amazing and pivoting completely for fun. Very different. Okay. Imagine you were to be offered the opportunity to teach a masterclass on any subject you want. It can be in your industry. It doesn't have to be, but you're going to get paid a million dollars to do so. What would you choose to teach and why? [00:36:11] Mark Oreschnick: So it's actually what we've already talked about and it would be networking. My experience with networking is it can have a huge effect on your career from day one. And luckily I've always liked talking to people. So I've been networking as long as I can remember, but people always say, "it's not what, you know, it's who you know." There is a, I'm going to say that should not be a truth. And if you actually live that way, there's a little problem there, because you should get the job because of what you know, and you should not take a job because it's just who you know and you're not qualified. But as long as you are qualified for that position, the who you know is going to introduce you to so many more opportunities, and if you go into all of those relationships trying to figure out how you can help others, people are naturally going to help you. [00:37:10] But as a student, you know, one of the things from our networking one on one class, we had the student saying, "what do I have to give to people when I'm networking? I'm still in school. I just, I'm about to graduate." During the conversation, ask them the type of people they want to meet at that event. And when you're walking around talking to others, if you meet that person, bring them over and introduce them. You can be their ears and talk to more people for them. You always have something to give no matter what. [00:37:46] Maybe they have a kid who's thinking about going to school and you could talk to their kid about what school you went to. You always have something. So going out, having that attitude, but every job I have gotten throughout my career, someone has introduced me to that position. My first internship was one of my lab partners in college. " I'm doing an internship. Would you like to meet my boss?" So yeah, I wasn't networking to do that, but we were friends from a class, so it was the who I knew. [00:38:24] Lindsey Dinneen: Yeah. [00:38:25] Mark Oreschnick: And every, like I said, every job has been that way. The doctors that found me on LinkedIn, they found me because of my posts about networking. [00:38:37] Lindsey Dinneen: Nice. [00:38:38] Mark Oreschnick: So direct indirect, my networking had me meet those doctors and turned into a client. [00:38:46] Lindsey Dinneen: Yeah. [00:38:47] Mark Oreschnick: So it's just, it always happens. Go out, meet people, talk to them, learn how to do things out of the goodness of your heart, and it will take you a very long way in your career. And when I think of people you and I both know that we've worked with, how many relationships have those people made throughout their lives that have now become business? It's just always happening. And so, yeah, that would be my courses to, especially with young engineers, young anyone, teach them, "You're getting into industries, start networking, learn the people in your company, learn the people at your suppliers, build your network, be good." And it will help you. [00:39:34] Lindsey Dinneen: Yeah. And be a go giver. I love it. Yeah. I love that. That's a great idea for a masterclass and it does not surprise me at all that's what you chose. [00:39:44] Mark Oreschnick: Yeah. So during startup week, I did two classes. It was the networking and "Key Considerations When Starting a Medical Device Company." [00:39:54] Lindsey Dinneen: Nice. Yeah. That seems accurate. Phenomenal. Phenomenal. [00:40:00] Mark Oreschnick: Go to your strengths. [00:40:01] Lindsey Dinneen: Yeah. Yeah. I love it. Yeah. Okay. How do you wish to be remembered after you leave this world? [00:40:10] Mark Oreschnick: Definitely want to be known as someone who took care of his family because family is obviously important, but within my career, I was the guy that helped. Whatever it was, I figured out a way to help people. [00:40:25] Lindsey Dinneen: I love that. [00:40:26] Mark Oreschnick: So. [00:40:27] Lindsey Dinneen: Yes. Absolutely. Okay. And final question. What is one thing that makes you smile every time you see or think about it? [00:40:36] Mark Oreschnick: My daughter. [00:40:38] Lindsey Dinneen: Aww. [00:40:39] Mark Oreschnick: So, that's an easy one. I have a 17 year old daughter. And I'm the first person to have a female in my family. I'm one of three brothers. My brothers have three sons and then I have the daughter who's the youngest of all of us. So I'm thinking, "Okay, I'm Mr. Mechanical. I love working on things. I love nuts and bolts and stuff." When she was two, she grabbed a screwdriver when I was working on the refrigerator and put it on the screw. So it's kind of, okay, there's my kid. She's definitely mine. And as I've watched her growing up, she has the same analytical mind as me, likes to divide things into even sections, things must be uniform, must be organized. But as she's growing up into a young woman, she is now a member of our church's youth group and she is a mentor to all of the other students. So she goes out and works with other kids and helps them at camp and does confirmation and she's just become a really good person. So looking at her, always smile. [00:41:57] Lindsey Dinneen: Oh, that's so special. Yes, and you're her up for massive success and sounds like she's just a lovely human, so. [00:42:06] Mark Oreschnick: She is. [00:42:08] Lindsey Dinneen: That's incredible. Well, this has been so much fun, Mark. I am so thankful for you and your time today. And, you know, we are so honored to be making a donation on your behalf today to Feeding America, which works to end hunger in the United States by partnering with food banks, food pantries, and local food programs to bring food to people facing hunger. And also they advocate for policies that create long term solutions to hunger. So thank you so much for choosing that charity to support and... [00:42:40] Mark Oreschnick: Thank you. [00:42:41] Lindsey Dinneen: Yeah. Well, and thank you so much for everything that you're doing. I just wish you such continued success with your business, with your networking group as you work to change lives for a better world. [00:42:54] Mark Oreschnick: Thank you very much for having me on. I enjoyed this. [00:42:57] Lindsey Dinneen: Excellent. And thank you so much to our listeners for tuning in. And if you're feeling as inspired as I am right now, I'd love if you'd share this episode with a colleague or two and we will catch you next time. [00:43:10] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Tim Balz, a former SpaceX engineer turned CEO of Kalogon, shares that his passion for MedTech began in high school when he founded a wheelchair refurbishment charity, Freedom Chairs. From creating the Intel connected wheelchair, endorsed by Stephen Hawking, to running a company developing innovative seating technologies, Tim's story is one of relentless innovation and profound impact. His mission? To enhance the quality of life for people with disabilities and beyond. This episode is a testament to the power of engineering and empathy in creating a better world. Guest link: https://www.kalogon.com/   Charity supported: Save the Children Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 031 - Tim Balz [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. [00:00:50] Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host Lindsey, and I am so excited to introduce you to my guest today, Tim Balz. Tim is a former SpaceX engineer with over a decade in the wheelchair seating space. He has 12 years of firsthand wheelchair experience. He founded a wheelchair refurbishment charity at the age of 15 and has donated over 150 wheelchairs, including orchestrating an international expansion into Moldova. He created the Intel connected wheelchair endorsed by Stephen Hawking, and has been invited to design a custom wheelchair for Hawking himself, which has been named the number one IoT device of the year by Intel. Currently Tim serves as the CEO of Kalogon. [00:01:37] Well, Tim, thank you so much for being here today. I'm so excited to talk to you and hear more of your story. [00:01:44] Tim Balz: Yeah, I'm excited to be here. Thanks so much for having me. [00:01:46] Lindsey Dinneen: Of course. Well, I would love if you don't mind starting off by sharing a little bit about yourself and your background and maybe what led you to MedTech. [00:01:56] Tim Balz: Yeah, absolutely. So, so I'm Tim Balz. I'm founder and CEO of Kalogon. So I've been working in and around the wheelchair space specifically for well over a decade now, starting with a nonprofit in high school now leading up to Kalogon where we make the world's most innovative seating for people, such as people use wheelchairs and really anyone who has to sit for long periods. [00:02:17] Lindsey Dinneen: Yeah, that's incredible. Would you mind starting a little bit at the beginning and sharing, how did you even come up with the idea to start the nonprofit, and you were so young and that's such a wonderful thing. How was that even received? Just what led to that whole part of your journey so far. [00:02:33] [00:02:33] Tim Balz: That's, yeah, it's actually kind of an interesting story, 'cause I was a part of a robotics team in high school, and so I kind of started learning to, to build things with my hands. I didn't really have any plans to go to college or anything like that, and my grades weren't the highest, but I had a neighbor that actually found a wheelchair in a dumpster, and he gave it to me to mess around with the robotics team, but I noticed there was this student in the school, Steven, and he would pull the recycling behind his manual wheelchair, and he'd go from classroom to classroom, and they would dump the recycling in it. [00:03:01] But after a while it would get so full that he would just be stuck there waiting for someone to come wheel him back. And so I asked his teacher, why didn't he have an electric wheelchair? And he actually his teacher actually said that the insurance company denied it, because he could move something like a hundred yards under his own strength. And apparently there's this, like, in the home rule and because of some unnecessary red tape he wasn't given the equipment that he very clearly needed. [00:03:24] So that first wheelchair was unfixable. So I traded my moped for a wheelchair on Craigslist. I tricked it out. I added like a sound system to it, added leg rest, added a hitch so he could pull his recycling, put his name on it, and really made it custom for him. And it totally changed his life. And then from there, I just had a bunch of people start coming to me in need. And, I was always raised to not necessarily have to wait for someone to ask for help in order to offer it. And I was raised that if there's something you can do to solve a problem for someone else, you should do that. And that's how I started out my nonprofit Freedom Chairs. [00:03:58] Lindsey Dinneen: That's incredible. What an amazing story too. Thank you for just sharing about that. And being willing, like you said, I love your emphasis on, you don't necessarily even have to be asked. You saw a need, you saw a way that you could help, and then you just took it and ran. And I love that. Yeah. So since then, you know, since that was sort of the inspiration, but then since then you have done so much with this organization. Do you mind sharing a little bit more about the work that you all do now, even with that? [00:04:28] Tim Balz: Yeah. Yeah, so Freedom Chairs would refurbish and we give away primarily power wheelchairs, but also some like manual wheelchairs and scooters. So we still run that. It's not at the same scale, you know back when I was in high school and college I a lot more free time than I did now, so we still probably give away five six seven chairs a year. But we actually took Freedom Chairs all the way to going international. We actually took a bunch of wheelchairs into Moldova, and that was a really cool project went over there a few times and then so still run that. [00:04:59] And then actually off of that, I realized I learned a lot about how these chairs work from repairing them and actually got hired by a design firm that was designing an all terrain wheelchair because of that experience. And so working with them, I got my name on the patent and actually helped design a wheelchair that's on the market today. I'm not associated with the company in any way. I was employed by the design firm, but that was where I started figuring out that, oh, I could give away these wheelchairs, but if I can actually improve the products that are available, I can help a lot more people than what I ever could hope to with a small nonprofit. [00:05:31] Lindsey Dinneen: Wow. Yeah, that makes a lot of sense. And so you then from starting this nonprofit, then from there, you've obviously had quite a bit of really amazing experience. You've been a SpaceX engineer and whatnot. Can you share about how those past experiences and your desire to help people have merged with all of your technical expertise over the years to create your company and what that has looked like? [00:05:58] Tim Balz: Yeah, absolutely. So, you know, I became an engineer because of what I learned with Freedom Chairs. I learned that with engineering, you can change a lot of people's lives. And so, the first thing I did was I knew that technology for people with disabilities was way behind the rest of the world. So that's where I did the the proposal for the world's first smart wheelchair and actually got that funded by Intel. They sponsored the project,, and then Stephen Hawking endorsed it, and it was named the number one smart device of the year by Intel. So that was really cool. That was where I was able to take technology and really advance the state of technology and in the space, but from there I knew that I still had a lot to learn before I could go start a company or something like that in the space. [00:06:36] And so I knew SpaceX was the place where my friends would go and they would learn so much more working there than other places, partially because you work such crazy hours. When you're doing 80 to 100 hour weeks, you're learning twice as much as someone that's working 40 hours. And that's what I wanted. I wanted to learn as quickly as possible, and I wanted to be at the forefront of technology so that I could take those learnings back to the back to people with disabilities so that they didn't need to have technology that was a decade plus behind what the rest of us get in our day to day life. [00:07:03] And so I stayed at SpaceX and actually moved to multiple different teams that were different phases in the product development and commercialization cycle so that I could learn how is it that SpaceX, this scrappy startup, was able to completely disrupt a space that was dominated by multi billion dollar companies. And with those learnings, that's where we started Kalogon and we actually structured a lot of our processes based on the learnings I had from working there. [00:07:30] Lindsey Dinneen: Yeah. Yeah. That's incredible. And so now can you share a little bit about what your company does and the products that you're really excited about and... yeah, I'll stop there, 'cause I, I'll ask too many questions all at once. [00:07:46] Tim Balz: Oh, no worries. I'm so, I love geeking out on the technical side. [00:07:49] Lindsey Dinneen: Excellent. [00:07:50] Tim Balz: So, you know, Kalogon, when we started Kalogon, what was really important is focusing on the need first and then building the technology for it. So many people just love technology and they're like, "We just want to shove technology into the end user's face. And we'll try to find a need based on the technology we want to build." And we didn't want to do that. So, we first went out and just started interviewing as many people as possible and said, " What are the big challenges that you have in your day to day life because of your disability?" [00:08:16] And we talked to everyone from the clinicians to the end users to even the family members to try to understand what are the largest unmet needs for people with disabilities. From there, we discovered pressure injuries. And we did this actually while I was still working at SpaceX full time, I even bought a house and all the co founders with me, they all moved in the house and we made it where their rent was able to pay for the mortgage on it. And we started using that to prototype and really start building the team. So we start with the team and the need. And when we found out that this need, these pressure injuries killed more people than any cancer in the US other than lung cancer, we were like, "That's crazy. Someone else has got to be solving this problem. We're probably way behind on this because of how big this is." [00:08:59] And then we looked and we're like, "Oh my gosh, there hasn't really been any innovation in like 50 years." And it just was mind blowing this something at the scale of cancer And the, still the leading technology that was being used to try to prevent these sores for people in wheelchairs was like twice my age at that point. And that was just crazy. So, so we said, "All right, there's the problem we're going to solve. Now let's go dive into that, become experts in that, and try to figure out how we can start iterating a solution to solve that problem." And that's how we created Kalogon Smart Seating technology. [00:09:30] Lindsey Dinneen: Wow. That's incredible. Was there ever a time as you're creating this technology and you're talking to the people who are going to be using it and so deeply affected by it, was there ever a time when you just kind of had this moment of realization where you went, "Yes, this is why we're doing what we're doing." This is a moment that really kind of enforced that. [00:09:53] Tim Balz: It's almost like a weekly basis. Like some of the early ones, we had early prototypes that we, we didn't expect them to succeed, because they were so early. And we had a, an individual where their, their wound care doctor came to us and was like, "Hey, I've tried every cushion on the market, their wound's not healing. It's probably going to take them out. And so I heard about what you were doing from, you know, some of the people that you were asking questions in the community to try to understand this problem. I was wondering, do you have anything?" [00:10:21] And we're like, "We have this prototype. It's completely unproven, but if you want to try something, if you're at the point of, almost, it felt like giving up, let's give it a shot." And being able to see that progression and finally hear from-- actually, what my favorite part with that one was-- a couple of months after we provided that, that cushion I was out at at a lunch with a prospective investor. And all of a sudden I had someone like call over to me. I turned around and it was the individual that we given this cushion. I'm like, "What are you doing out?" And she was saying that the cushion was so successful, that they let her go out for lunch with her friends and then come back to the rehab facility, and that she thought she wasn't ever going to get to do that again. [00:10:58] And that, that along with the fact we get multiple Christmas cards every year from people that say we changed their life and that they thought they wouldn't be able to go visit their grandkids again, or that they're able to now, instead of sitting in a chair for two to three hours a day, and that's all they get to go live their life, because of the pain reduction from the technology, they're able to be out for eight to 12 hours. Those instances always really fuel the passion because start ups a rollercoaster. [00:11:23] Lindsey Dinneen: Yeah. [00:11:23] Tim Balz: There's ups, but there's typically a lot more downs than ups in a startup. You're trying to solve problems that have never been solved before. And that's hard. That's really hard. And that's the startup kind of journey. It's lonely. You've got your co founders, but it's tough. And those moments are always the ones that make it all worth it. Every, any one of them is enough. [00:11:38] Lindsey Dinneen: Oh, I love that. Yeah. And I love your perspective on that too, where you said all of it matters. And it's just one, you realize how many times that one person has made a difference, and that one person matters so much. And I love that perspective because like you said, it is such a roller coaster and that's a lot of challenge that you're dealing with on a daily basis. It would be easy to get discouraged or feel like, "Oh my goodness, is it worth it?" So being able to talk to a human being who goes, "Yeah, it is worth it." You know, that's, there's nothing quite like that. That's very rewarding. Wow. [00:12:15] Tim Balz: It's true. And then at the end of the day, the people that change the world are the optimist. And so knowing that, I'm not going to give up, the team's not going to give up, until we succeed. That's that along with the positive reinforcement from hearing these stories, people's lives were changing, it really does make it all worth it. 'Cause at the end of the day, if we were in it for the money, I should have stayed at SpaceX. I walked away from a lot of SpaceX stock that was still left unvested, and I regret nothing because at the end of the day, I'm doing what I need to be doing in the world. My goal is, let's say, when I die, I want to know that I put in more than I took out. And so I want to create the largest net positive on the world possible. And I think Kalogon is my way to be able to do that. I'm solving problems that wouldn't likely get solved if Kalogon wasn't doing it. [00:13:04] Lindsey Dinneen: Yeah. That's incredible. And so what are you looking forward to as you continue to grow the company and even for yourself, you are continuing to grow in this role too. But, for yourself and then for the company, what excites you coming up? [00:13:22] Tim Balz: Yeah, we've got a, we've got a Series A coming up in 2024. So we're really excited about that. One of my favorite things about the job is, in a startup, especially when you're a first time founder, you've got to make sure you grow personally at a rate faster than what the company is growing otherwise it's going to outgrow your competence.And so I'm always looking for and getting feedback from our board, for example, and then the team is, "What are the things that I'm going to need to do six months from now? What are the skills I'm going to need to have to be able to successfully run this company?" [00:13:53] And then that means I get to do tons of learning. And with that learning, I know I'm growing as an individual. It's going to make it where someday, post Kalogon, I'm going to want to start something else and solve more problems. And the learning I'm getting is one that's, it means having a new challenge every day where I don't already know what the answer is when the challenge pops up. That keeps me motivated. [00:14:15] Like this morning I woke up at 3am and I was like, that's what we need to do for our CNC machining on that part. And even though I'm the CEO of the company, I literally was like texting one of our engineers. I'm like, "Oh yeah, here's what, like check this out," like moment of clarity. "This is going to totally improve the efficiency and solve that challenge that we have in the organization." [00:14:34] And while typically I'm not solving challenges at that level anymore, I'm more equipping people and putting the right people in the places, and they're truly the ones doing the innovation now, I still like to try to make sure I understand what are the challenges that are limiting Kalogon's ability to impact more people's lives. And and that's like my personal litmus test. I've always said, even when I was at SpaceX and one of the reasons I left was, if I'm not doing something that's so interesting and challenging me so much that I, that it doesn't keep me awake at night thinking about it, then it's probably not, it's probably not the right thing for me to be doing. [00:15:09] Lindsey Dinneen: Yeah. And so how was that transition for you? Did you enjoy going from sort of more of a doer role to a leader role? Was that an enjoyable thing or was it really challenging at times to sort of, you know, you have the heart of the company. So was it a little hard to go from being so hands on to being at a little bit of a higher, eagle eye view? [00:15:32] Tim Balz: Yeah. I'd say the process was a bittersweet one. At the end of the day, if my goal is to have the largest net positive impact, this is what I need to be doing. So from a, from being a rewarding side, it's so rewarding. I would say like, it was something where, of course, there were times when I had a hard time letting go of specific tasks that really I'd outgrown that as being something that I should have been doing in my role. There were times where I had a hard time emotionally giving it up, but I never had a time where I like wanted to jealously guard something just because I enjoyed doing it. [00:16:04] At the end of the day, I look at my job as, I wear a lot of hats, and if I'm doing my job effectively, I'm setting other people up so I can take that hat off, give it to them, so that I can be putting on a new hat for what the company needs next. And so if I'm not doing that, then I'm not doing my job. And so being able to take a job that I love doing and equip someone else and see them be successful in it, that's where I get my rewards now. [00:16:30] Lindsey Dinneen: Yeah. Oh, I love that. I love that perspective too, and I think it's very telling about your leadership that you are so willing to learn and grow at a pace that will enable you to continue leading at such a high level, because it is, that is challenging and, I'm sure that there will, like you've mentioned, every day you have a new opportunity to solve a problem that might have been a little just out of left field, but if you're continuing to help grow your own skills and you're able to continue to lead the company well. So out of pure curiosity, what kinds of learning tools have you found to be particularly effective? [00:17:10] Tim Balz: Yeah. So one, I'm a big reader, but like audio books. So I'll look at what are the skills I need. And I'll go, so one, mentorship is huge for me. I have a ton of mentors, and often I'm working directly with those. I have a technique I call verbal iteration, where I just like, will throw ideas at people who have good insights. And I'll have them tear it apart, throw it back. And I have no ego about things needing to be my ideas, so I steal the best of their ideas. And now I change my new idea, and then I'll throw it at someone else. And that way I can get a lot of diverse opinions and diverse perspectives. And so that's one way where I'll kind of change my mental models for how I look at the world. [00:17:47] And then another thing I do is, so lots of audio books, I listen to very specific podcasts. I'm a big fan of podcasts. When I'm driving, I often you use audio books and if I'm doing like tasks around the house, I'm always listening to podcasts. And I go on runs in the morning, always got a podcast on, but besides that mentorship is the big one. And then I do have a strategy coach 'cause strategy is one of those things that, it's so abstract, it's hard to truly absorb it from just a one way transfer of information from audiobooks. And so I do have a strategy coach that, we look at like case studies and, and he'll help me apply those to our business and make sure that I'm truly leading the company in the right direction. [00:18:26] Lindsey Dinneen: Yeah. Yeah. That makes a lot of sense. Thanks for sharing that. I'm always just intrigued because it's fun to keep learning and growing and everyone has different methods of doing so, and I'm always just fascinated to hear how someone wants to do that, enjoys doing that. So you know, looking back over your life so far, could your six year old self have possibly imagined what you'd be doing now, or is this completely out of left field? [00:18:53] Tim Balz: I love that you use that analogy there because one of my favorite things, whenever things are going rough, like I have to do a ridiculous amount of travel. And I think a lot of people romanticize work and business travel. We're a startup. I'm sharing hotel rooms. I'm trying to get the cheapest I can get. I'm flying Spirit, back row, middle seat, red eye to save money. [00:19:16] Lindsey Dinneen: Yeah. [00:19:16] Tim Balz: Because at the end of the day, we're a startup and any dollar I can put back into the business is, it's more innovation. And so for me, when I'm in those moments, I'll always think back, would younger me be proud? And I'm like, man, younger me would have been so jealous of being able to fly on an airplane. I got to fly on one or two airplanes when I was a kid. And I'd be like, okay, younger me would be pretty proud of and pretty, pretty jealous that the older me gets to go fly around the world to have business meetings and go try to solve engineering problems. So I really do think that six year old me would never believe that I would be so fortunate to be in the position I am to be able to build and innovate and change people's lives. [00:19:58] Lindsey Dinneen: Yeah. Yeah. That's incredible. And it's helpful to have those perspectives too. We talked about earlier a little bit about knowing because you can, and because people send you cards and they talk with you, it's like being able to know that your younger self and the people that you're currently affecting are grateful and proud and whatnot. It just, it really does help, like you said, because those red eyes are not always super fun, I'm sure. And there are days where it's a little more demotivating than others. So [00:20:30] Tim Balz: Absolutely. [00:20:31] Lindsey Dinneen: So what kinds of other big engineering challenges would you be thrilled to help solve? [00:20:40] Tim Balz: I mean, one thing we've kind of realized is, our initial goal was to take technology for people with disabilities and try to at least bring it up to the level of what's provided to people without disabilities. And one thing that ended up happening was, we truly went to solve this need and did such a good job of it, that we realized our technology can solve problems for a lot of other areas in the world where people have to sit for extended periods. And that was something that wasn't the initial intent. We just went to go build what was right, not what was easy. [00:21:12] And what's exciting for me is we've now got contracts outside of the wheelchair space where we're able to keep funding and putting more money and effort into R&D to just understand and become the world experts in seating. And so the way I look at it is, there's no one in the world that knows more about dynamic seating and seating that actually changes based on the user, no one can do anything like what we're able to do. And so I'm excited for things like. airplanes, automobiles, long haul truckers, construction equipment. [00:21:41] There's so many different areas where people have such a negative impact on their health and wellbeing because they have to sit for long periods. I mean, look, office chairs. And so I am really excited to, to make Kalogon's technology available to those people so that they can, at the end of the day, go home and play ball with their kid, or pick up their kid without, without back pain, or without one of the many other medical issues that can arise from sitting so much in our days. [00:22:09] Lindsey Dinneen: Yeah. Yeah. Oh, I love that. And I'm very thankful for what you're doing. I love that the work that you all do and that you are so passionate about becoming experts to help solve some problems that have-- like you said it's kind of wild when you think about it-- that the technology hasn't evolved, or maybe emphasis hasn't been placed on this kind of technology, and lots of people are affected by it. [00:22:35] Tim Balz: The average person sits more than they sleep, which is crazy to think about, yet the research in the space on sitting is so narrow, and it's still in its infancy. Like the fact that a company our size can become leading experts so quickly, it's post a testament to the team we have, but it's also, it just shows that there's so much runway here because this is a problem that it's just going to keep getting bigger as the world ages and as more people are sitting as part of their job. [00:23:06] Lindsey Dinneen: Yeah, of course. Well, I just think it's really amazing what you guys are doing. And it's cool to hear all about it. So I'm, I just, I want to pivot just for fun. Imagine you were to be asked to give a masterclass on any subject that you want to. It can be in your field. It doesn't have to be, but you're going to get a million dollars to do it. What would you choose to teach and why? [00:23:31] Tim Balz: I believe. So I think I would start with, what is the criteria that would help me decide what area to teach? And I would say, what is a skill that I've had to build where I was not able to find a lot of resources to help me learn how to do that. And so, there's a lot of things out there. There's 20 masterclasses in leadership and project management and those things. So no one needs another, no one needs another masterclass in that. And there's a lot of people, a lot smarter than me at that stuff. [00:24:00] I would say, how to innovate as a hardware company, and how do you do that in a cost effective manner? I think one of the things I learned at SpaceX, I have a very different approach to product development, especially with hardware products. We at Kalogon, we treat hardware like software in a way that very few companies do. And I think sharing that so that other startup founders who are afraid to go do a hardware starter, 'cause typically people think you need a huge amount of capital, and people build products without properly iterating with customers in the loop. So like empathy driven design and early product manufacturing, test, and iteration, I think is something that there's not a lot of great resources out there. And I think a lot of people could learn from it. [00:24:49] Lindsey Dinneen: Yeah. Yeah, I think that would be an incredible masterclass, exactly for all the reasons that you mentioned. And it is a difficult subject area, so that would be phenomenal. [00:25:02] Tim Balz: Where a lot of companies die too, is they don't get the product market fit right. They don't create a system to be able to validate and do a bunch of tiny pivots to make sure that they truly build a product that solves a problem, and solves a problem that's worth solving. So, so I think there's a lot of companies that have to fall into those traps. [00:25:22] Lindsey Dinneen: Yes. "Solving a problem worth solving." I really like that. So, how do you wish to be remembered after you leave this world? [00:25:32] Tim Balz: For me, I don't care super much about what people think about me. I care about my reputation, and I think that's really important. But for me, I more care about building lasting businesses that, when I'm gone, continue to drive value, and specifically drive value for their customers above all else. That would be a pretty cool way to be remembered. The teams I've been a part of if, if they're continuing to be successful, I'd love to have people in that business remember me because a lot of people I work with are like family. You spend more time with their coworkers a lot of times than your significant others during a week, especially in a startup. [00:26:09] And so, so definitely would like to be remembered as someone that always put the customer first and made sure that. That I was providing value for others above all else. And then, of course, I want to make sure my family remembers me fondly. I want to make sure that one day I can actually throttle back and, have kids and be a good dad. And hopefully they can feel that I did a good job raising them one day. But right now I have no kids. So. [00:26:30] Lindsey Dinneen: Yes. Okay. Perfect. And then, final question. What is one thing that makes you smile every time you see or think about it? [00:26:40] Tim Balz: I mean, it's going to be my wife. She's pretty amazing. Totally out of my league, way smarter than me. And, and having a startup founder as a husband is-- it's, I don't know what it's like. I can assume I have, I know I can be pretty difficult sometimes not knowing if I'm gonna have to stay super late to help with a product launch or the stress of doing an investment round is, it's a lot. So I would say anytime I actually get to see her and spend time with her, that's, that's my favorite activity in life. [00:27:09] Lindsey Dinneen: That's special and it is worth holding on to. I love that. Amazing answer. Well, I just want to say, this has been so much fun to get to know you, get to know your company, and get to know the heart behind everything that you're doing. I love hearing the story of what first sparked your interest in this particular thing that you couldn't have necessarily predicted would end up being something that you really chose to focus on. But I love the synergy that has occurred throughout your life so far and that you've been able to take all these little pieces and put them together, and it's just really cool to see that. And so I just wanna, again, just say, thank you for the work you're doing. I know being in a startup, , running a startup, is a lot of work, is really hard. But, thank you for being here. [00:27:59] Tim Balz: And thank you for sharing the stories. There's a lot of founders out there that, they're out there solving problems that are, they're really important. And I love the perspective you're trying to bring so that people, understand that a lot of people, especially in the medical space, they're out here not just in it for the money. We're in it because we want to change the world. If we're in it for the money, it's so much easier to just go work for Johnson and Johnson or GE Health or something like that. And it's it's a tough road. So I appreciate you putting the spotlight on on founders. [00:28:25] Lindsey Dinneen: Yeah, sure. Absolutely. My, it's my pleasure. I get to meet amazing people like you and I love that. So, I'm happy. Well, again, thank you so much for joining us. We are so honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational, and safe environment. So thank you so much for choosing that charity to support. And we just wish you continued success as you work to change lives for a better world. [00:28:59] Tim Balz: Absolutely. Thanks so much. [00:29:01] Lindsey Dinneen: Thank you. And thank you also to our listeners for tuning in. And if you're feeling as inspired as I am at the moment, I'd love it for you to share this episode with a colleague or two, and we will catch you next time. [00:29:14] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Roy Morgan, CEO of Eagle Medical, shares his unique journey in the MedTech industry, starting from a pivotal one-question interview in 1997 that set the trajectory of his career. He reflects on his experiences in leading groundbreaking projects, emphasizing his deep-seated desire to improve and save lives. Roy's approach to leadership is both inspiring and intellectual, demonstrating a commitment to excellence and a profound understanding of the impact of his work.  Guest link: www.eaglemed.com Charity supported: Sleep in Heavenly Peace Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 030 - Roy Morgan [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. [00:00:51] Hello, and welcome back to The Leading Difference podcast. I'm your host Lindsey, and I'm so excited to be speaking with my guest today, Roy Morgan. Roy has had a distinguished career at multiple medtech corporations. His experience includes team building, platform strategy, intellectual property filings, project management, budgeting, and scheduling. His project design and engineering skills are highly sought after in the medical device field, and Roy has a BS in Mechanical Engineering, a BA in Semiotics from Brown University, as well as a degree in project management from the University of California at Berkeley. Roy currently serves as the CEO of EagleMedical. [00:01:32] Roy, thank you so much for being here. [00:01:34] Roy Morgan: Well, it's wonderful to be here, and thanks for having me. [00:01:36] Lindsey Dinneen: Course. Well, I would love if you don't mind starting off by sharing a little bit about yourself and your background and what led you to MedTech. [00:01:45] Roy Morgan: Sure. So, my journey into medtech started in 1997 with a one question interview phone call. And it was an amazing moment in my career. I'll never forget it because it was only one question, and the question was, "Can you invent?" And I'll never forget it because I'd never heard that question asked before. You know, looking back now on a 30 plus year history in med device, I think I answered the question right. But some days I'm still not sure. [00:02:15] I started out after that working for the Stryker endoscopy division of the Stryker corporation, was the lead innovator commercializer of their, I guess it's currently called the Crossfire Electrosurgical System. So I drove, you know, those things into market. I worked on their sports med team for a while, went on from there to work for some small startups doing other RF innovations in you know, tissue excision spaces, treatment spaces, then did some interesting work for Abbott diabetes care that launched I think people can see that now on television, it's called Freestyle Libre, it was originally known as Navigator. I was part of that development team in the early 2000s that got that off the ground and into the market [00:03:07] Subsequent to that, went to do additional in vitro diagnostics and diabetes work for some startups in florida And then came back to the Bay Area, and found myself kind of wanting to do something a little bit different, and chose to work with a company called Eagle Medical to drive sterilization, packaging, and innovations in assembly technique and you know, speed to market from the last operations process standpoint. And that's where I find myself today. [00:03:42] Lindsey Dinneen: Very nice. Well, thank you for sharing a little bit about your background. Did you always think that you might be an inventor or was this something that kind of came about over time? [00:03:53] Roy Morgan: Well, you know, it's interesting. That question, if you can imagine yourself taking a phone call and thinking like the recruiter building this up as like, "Wow, this is the next greatest company since, you know, I don't know, Johnson and Johnson" or something like that. And you feel all this pressure. And then it's one question. And I can't tell you exactly how I answered it. It was something to the effect of, "Well, I can't be 100 percent certain, but I believe with every cell of my being that I can do it." And I guess it was good enough to get the next round of interviews. It worked out. [00:04:29] And today I'm blessed to have been part of just an amazing industry. The things that I have been able to participate in, that I've seen done that are going on today, and that we continually, through Eagle, help produce for the greater global community, just amaze me. It's remarkable what we are able to do. It's even more remarkable the things that we're targeting to do in the coming years. [00:04:56] And so all of that just kind of makes me think: I hope I can continue to invent and do things. I've been blessed and fortunate to have more than a few patents to my name at this point. So I think there's some truth to the answer I gave, or at least I, you know, I kidded myself into believing it and it worked out. [00:05:15] Lindsey Dinneen: Well, yeah, you believe it and then you do it, right? So hey, you're just... [00:05:19] Roy Morgan: There's lots of phrases for that. I won't use them here, but you know, it worked out is what I'll say. [00:05:25] Lindsey Dinneen: Fantastic. Well, if you wouldn't mind sharing just a little bit about your work today with Eagle and just share a little bit about your heart behind it. I know you're very missions and values driven, and I would love to hear more about that too. [00:05:39] Roy Morgan: Sure. I'll start with our why, because I think that's the biggest and most important thing to understand. Our mission here at Eagle is to provide just the absolute best quality of service to our customer base, and our customer base comes in layers. But I always try diligently to remind our staff at every level in the company that the most important layer of customer that we have is the end recipient of the products that we package here. [00:06:15] They, as I like to tell them, they don't get a say. They're under anesthesia. They're unconscious. They can't see the quality of our work. They don't know, perhaps, even that it's part of the surgical process that there'll be receiving on any given day, of course, there's an implicit faith in our system that these products will be delivered in sterile conditions, that they are able to provide all of the benefit that surgeons, clinicians and support staff say that they can, and because our patients don't get a say, we have to do it right every time, all the time, without exception. [00:06:56] And that's something that we really try to drive home here to, to everyone that works at Eagle. It's part of what we do, and the other thing that I remind people about is that everything that comes through our facility has UDIs and part numbers on them, but that's really a misnomer. Each and every product that comes through here really has a name on it. And that name could be a sister, a brother, father, mother, could be your own name. And so remembering that, I think, really brings home the importance of what we have to get right every day. [00:07:33] Lindsey Dinneen: Yeah. Yeah. And have you had any particular moments where it just really stood out to you as confirmation that you were in the right place at the right time in the right industry? This awareness of, "Oh, wow, yes, this is why I do what I do here." [00:07:51] Roy Morgan: Wow, that's a great question. It's I don't know that there's like one moment. There are strings of moments that, that I can piece together in my mind. Most of it I think comes down to something that's deep seated in myself that has to do with desire for spreading good health to everyone around me, and I think it's... how do I say this? It's really something that's almost unconscious for me. There's a desire to see healing in people. [00:08:28] Without going into it really in my own background, there's healing that's had to go on for me and others in my family that are important things to support, to encourage, and to help along in the world. And those I think are, they're just very powerful beliefs for me. And so the moments in my career that kind of lend themselves to that, have been moments in operating theater with patients that are conscious. [00:08:58] Without getting too much into it, some very high profile athletes that have thanked me for the innovations that we brought into that operating theater that would enable them to continue their championship level sports endeavors. So it's about giving people a continued opportunity in life to do what they love to do to restore the life that they want and to have second chances when injury or misfortune might befall us, as it does all of us. [00:09:30] So I think those moments really stand out in my mind as, "wow moments" where, you know, you may not be expecting it, you, it catches you off guard and it gives you a little bit of introspection about your own why. Why am I doing this? What's my mission? So, yeah, those are the kinds of things that, that count. [00:09:51] Lindsey Dinneen: Yeah, and I love the way that you put it earlier where you were saying how-- and I think it's very human nature-- we get into the nitty gritty of the details and, and sometimes it does feel like, well, it's just, it's a component, it's a part number, it's whatever. And I love the way you put it about how actually those are, they get assigned to people. Those are humans who are affected by each and every one of the things you produce. And I love your emphasis in general, just listening to you speak, your care for human life and bettering it and helping the next generation. [00:10:26] So I just want to say thank you for your perspective, because it's easy to lose sight of that when you're having to do such detailed work, I think, and I love that you continue to remind the folks that work with you and yourself, I assume, too, about how important this is, and it's, it's not just another day for somebody who's affected directly by what you're doing. And I think that's pretty cool. [00:10:49] Roy Morgan: Yeah. Yes. Thank you. It's really my honor to serve in this role. [00:10:54] Lindsey Dinneen: Yeah. Well, what are you excited about next as your company continues to grow, you continue to invent and innovate. What's exciting for you? [00:11:03] Roy Morgan: Well, so, you know in our industry, the past couple of years with the pandemic and other industry related challenges have made it a difficult time for a lot of med device manufacturing . Just to, to name a few, you've had supply chains that have gone upside down and sideways and every other way you can imagine. You've seen sterilization modalities come under intense environmental pressure, forcing closures throughout the industry of certain types of modalities, and putting pressure on the balance of the system to rise to the occasion and meet the excess demands, which of course, something like a pandemic raises to an entirely new level. I don't know if we understood it, prior to 2020, in the visceral manner that I think we do now that a strong healthcare supply chain, a strong healthcare technology sector is really a matter of national security. It's really a matter of being able to sustain our population and sustain our society at a level that is functional. [00:12:14] I think the events of the past two years have highlighted for everyone that importance. So, I speak about those things in terms of how it's raised awareness. The excitement that it creates within me for the coming years is that I see tremendous innovation in how we're going to make things more resilient, how we're going to make them more capable, more scalable. And here at Eagle, what we're doing specifically, is implementing new digital transformations of this last operations process workflow so that we are able to spool up to demand levels that might seem insane. But to do it without breaking the machine, if you will. [00:13:02] And I think a lot of a lot of companies out there, a lot of my compatriots that I speak to, CEOs across the industry, I hear the same echoes that, wow, there was just so much that had to be done that it was very difficult and nearly broke us to try and reach those levels of production. So I think building those systems now and putting those in place for us, really is exciting to look at the future to say, "Okay, we'll be much more ready next time around." [00:13:32] Lindsey Dinneen: Yeah, I mean, fingers crossed and all, there won't be that same. But I love that you are actively working towards it because I think you're absolutely right. It took so many people completely off guard and without having come up with a way to handle it ahead of time, it was very difficult for many people. So I love that you're going ahead and putting those systems in place to be prepared and, tackle it head on in the future. [00:14:00] Roy Morgan: One, you know, one of the things that we're doing just as part of evolutionary innovation in the packaging space, we've developed a new system that's called the "PATH System." It's our Packaging Accelerated Timeline Help. And what it is, it really represents the first step of digital transformation of packaging validation. Traditionally packaging validations have been thought of as the rigor that terminally sterilized device has to be subjected to, to get all the way through distribution to actual operating theater, and it is and has been so for many decades. But, we have continually been testing the same types of packaging for decades. [00:14:43] We, Eagle, just ourselves within our own production database, we've got millions of test data points that we can mine and use to our advantage. And in fact, we've done that. And what we've created is our own engineered proxy device that we validated inside of a packaging solution. So, PATH is really, I call it a time machine because what you're buying is not a pre validated sealed package that contains nothing but air. You're getting a full digital data package of a validated proxy device. [00:15:21] It can be adopted as a worst case for any product family that's out there. The short story is, you're buying time, which helps a lot of companies out there that are trying to bring life altering technologies to market. They can save that time and that money, of course, because they both go hand in hand, getting to market sooner and being able to deliver that life altering technology to potential patients so they can benefit from it. [00:15:47] We saw this as a natural innovation in the space of time compression, of the utilization of massive amounts of data in the historical canon that we have, and that other companies also have. So really, it just kind of made sense for us to move forward with it. It's now available. And we're seeing lots of interest and we expect to see a few companies take advantage of it in 2024 to get to market much more rapidly. [00:16:12] Lindsey Dinneen: So exciting. Oh my goodness. Yeah. Thank you for sharing about that. I'm excited to look into it a little bit more too, but it's great to see all the innovation coming out of this space and keeps the hope very much alive that there continues to be passion and innovation moving forward. So, you know, throughout your career, you've held multiple leadership roles, of course, and I'm wondering how you view leadership. What is your own leadership style or philosophy and what's your advice for someone who might be looking to get into a more of a leadership role in the medtech industry for themselves? [00:16:50] Roy Morgan: Sure. I'd say my leadership style is, I lead with inspiration and I follow with intellect. So it's pretty straightforward, but not easy to do. The inspiration is, I think, been popularized lately by Simon Sinek, who talks about start with "why." Well, that's what it is. Inspiration is the why. The intellect, that's what I call the mechanics of how to get it done. And that's really how I've gone throughout my career in tackling the various leadership roles that I have had the privilege of being a part of. [00:17:30] I guess what I would say is to anyone looking and thinking about how to be an effective leader, it's a, it's as much an exercise in vulnerability as it is an exercise in your commitment to your own mission. You've got to know what that is. If you're going to be a leader, you want to be a leader in some particular endeavor, it's going to require a personal commitment to believe in that, to move toward it, and to live up to it. You're going to lead by example, which is generally the best way. But you're going to put your own success in the hands of others. [00:18:16] I can't say that as a leader, the success is all mine, it's not. I've worked with some of the most amazing teams, the most talented engineers, the most amazing people who help make things happen in a way that leads to that success. And so that's the exercise in vulnerability. I often tell people being a leader means that you're willing to underwrite failure after failure without loss of enthusiasm. [00:18:43] Lindsey Dinneen: Yes. [00:18:45] Roy Morgan: And if you're, you know, if you're able to do that you'll get there. So. [00:18:49] Lindsey Dinneen: Yeah. Thank you so much for that advice. I really appreciate your perspective too. Yeah. And so how do you see that play out especially nowadays where, you're in this obviously top leadership role, and one of the things that you are so passionate about is this sense of mission and core values and why we're doing what we're doing. And so I'm wondering, what are some ways that you have found to be effective in shaping culture to reflect the core values and help ensure that alignment, because I know sometimes, it's lovely to write those statements and we believe in them and we want them to be true, but it can be hard in the day to day operations when things get tough and difficult decisions have to be made to really adhere to them. So I'm wondering, how do you go about that particular component of leadership? [00:19:43] Roy Morgan: You've caught me at an opportune juncture in my career. Let me give you the setup and then I'll tell you what's going on. For the past 20 plus, 30, almost 30 years now, I guess, yeah, 30 years, I have used a performance management system, a goal system, which most people are familiar with, that I'll work with individual team members, my direct reports and their sub teams, et cetera, to establish a set of goals. That's worked very well. It's been successful and has provided a great amount of accomplishment over that time period. [00:20:17] But recently I felt like I was getting stuck in a rut, that the goal system as effective as it is has become-- I'm not sure what the best way to put it-- other leaders out there who go through this sort of self check in or appraisal, if you will, will understand what I'm getting at. You're just wondering if, "Gosh, I haven't innovated myself in a long time." And I would say that this is the other challenging thing about being a leader: if you let yourself get stuck in a rut, you develop complacency. Just like teams, just like company, it all happens, but it can happen to you. And I think in 2023, I took a look in the mirror and I said, "You know what? I'm feeling a little complacent. I'm feeling a little bit like this goal system is just my go to thing. I've done it for 30 years." [00:21:09] And so this year, I am trying something very different. We're trying the Four Disciplines of Execution, the 4DX approach, to how we're going to run our team goals. So, people out there who are familiar with it will know what it is. I'm not going to go, it's not going to go into the details of it here. But Lindsey, what I'll tell you is, for me, it's terrifying at the outset because it feels like I'm taking my hand off the wheel. I'm entrusting my teams to develop their goal set, to set their timing, to set their commitments. [00:21:50] Sure, I took part in setting the what they call the "WIG," the wildly important goal for the year, right? But I didn't set it by myself. I had to call the team in and say, "Look, guys, this is where we are. This is the struggles we're going through. This is what we want to achieve going forward. Is this the right goal for us to focus on?" I created a proto goal, but it was modified and I was okay with that. So, it's basically a starting line, a finish line and a deadline, right? [00:22:21] And so we did that. They changed it. It's now created and I'm uncomfortable. I'm in that, I'm in that gray space of uncomfortableness where I'm trusting that the system, which has many successful reports is going to work for us in the same way. It's knocking me out of my comfort zone. And I did that to myself on purpose. I'm doing this because, for me, I know that's a growth zone. I'm going to have to stretch. I'm going to have to grow. I'm going to have to think differently moving forward. It's terrifying. [00:23:00] And I would say to other leaders out there, this is what you have to do. This is what you have to do to achieve growth, having mentors, having other inputs, those are valuable, and they work for me too. But really this is a question of courage. It's a question of courage. You have to step up to the plate. I'm taking a swing. I'm hoping I hit the ball and if I do, I hope it goes over the fence. [00:23:28] Lindsey Dinneen: I love it. Thank you. Thank you for sharing that. I I really appreciate first of all, you being willing to talk about that because it is uncomfortable when you're going through a growth season maybe whether it's your choice or not, but even more so, when it's your choice and you're going, "I'm doing this because it's like you know taking your daily vitamins or whatever, maybe something you don't love, but you know it's for your benefit in the long run," and, but I understand that curve of, "Oh boy, this is, there's a lot of change and we're gonna, we're gonna see how it goes." But I commend you for that. I really do. And I'm excited. I hope we get to check back in a year and all things, "Say, hey, how's it going?" [00:24:08] Roy Morgan: Great. Yes. I hope to have great reports for you. [00:24:11] Lindsey Dinneen: I love it. Well, that was great. I really appreciate that. Pivoting just a little bit for fun. Imagine someone were to offer you a million dollars to teach your masterclass on anything you want. What would you choose to teach and why? And also, it doesn't have to be in your industry. It can be, doesn't have to be. [00:24:31] Roy Morgan: Sure. I think for me it would be it would be about creativity. It would be about, it would be about how to organize your life to have creative moments at as many turns as you possibly can, because creativity in itself, people ascribe for whatever reason, I guess in Western culture, we talk about it as a, an element of productivity or an element that's woven into capitalism, if you will, in a way that I don't think it's necessarily-- no, in fact, I know this-- it's absolutely not meant to be that. [00:25:11] Creativity is a source of fun by and large at its core, at its absolute core. It's like being... How do I say this? Well, this happened to me the other day. I was out on my, my, on my bicycle and I came over this hilltop after a long, hard climb and I began this descent and it was it was so overpoweringly filled with joy, that for a moment, you forget what you're doing. You have to get back on task quick 'cause it's a mountain road and you don't wanna make mistakes. But in that moment, it's, it's just about the joy and the fun. [00:25:45] I think I would teach about that because there are so many, I guess, so many challenging moments in human life for so many people, that to have a structure to help themselves to bring themselves joy, well, that would be really rewarding. Yeah, so I think that would be what I would talk about: how those elements in, in my own life got me through some difficult periods and, saw me through to the other side. [00:26:26] Lindsey Dinneen: Yeah. I love that. [00:26:28] Roy Morgan: That would be it. [00:26:30] Lindsey Dinneen: I would totally take that masterclass. I'm all about creativity and joy, so, yeah. That sounds like a fabulous class to teach. How do you wish to be remembered after you leave this world? [00:26:41] Roy Morgan: Ooh, wow. That's, that's a question that combines both austerity and optimism in the same note. How would I like to be remembered? I guess if I had to put it in one sentence, as a song. I don't know, I don't know that, yeah, I don't know that song is fully written yet. [00:27:04] Lindsey Dinneen: Yeah. [00:27:06] Roy Morgan: Yeah, I think that's how. [00:27:07] Lindsey Dinneen: Okay. Now, would it be instrumental or would it be a lyric-ed song? [00:27:15] Roy Morgan: It would probably have few lyrics and it would be mostly music. [00:27:21] Lindsey Dinneen: Okay. I'm digging it. That's by far the most creative answer I've ever gotten for this question. So I I'm loving it. [00:27:29] Roy Morgan: Well, it's, there you go, creativity, right? [00:27:32] Lindsey Dinneen: There you go. [00:27:33] Roy Morgan: That's what it's all about. [00:27:34] Lindsey Dinneen: Reoccurring theme. I love it. Yeah. And, and final question, what is one thing that makes you smile every time you see or think about it? [00:27:45] Roy Morgan: Oh, wow. One thing, there's so many things I'm lucky like that, that do that for me. I, well, the one thing that pops into my head right now is the sunrise. And I guess that, that kind of ties it in for me. I have this saying that I tell people, in fact, I was just doing a whole bunch of it here on New Year's Day. I say this all the time to myself and to others, "Well, here is another 365 chances to be great." [00:28:15] Lindsey Dinneen: Yeah. [00:28:16] Roy Morgan: So with each sunrise, a new chance to be great. [00:28:21] Lindsey Dinneen: Yes, and that's definitely a reason to smile. There's new hope every day. I love it. [00:28:28] Roy Morgan: May sound a little corny, but it works for me. [00:28:29] Lindsey Dinneen: I'm all about the corny when it works. Sometimes even just the corny for corny's sake. Let's be real. Yeah, well this has been an amazing conversation. I really appreciate you. I love the work that you're doing, but I especially resonate with and so value the emphasis that you put on remembering that what you're doing and the work that you're producing matters so much and it matters to humans and it's not just another part coming out. And so I just want to reiterate again how much I appreciate the way that you talk about that and the way that your company actively works to change lives for a better world. [00:29:09] So thank you for what you're doing and what you're bringing to the world. And I just really appreciate it. And we're excited to be making a donation on your behalf, as a thank you for your time today, to Sleep in Heavenly Peace, which provides beds for children who don't have any in the United States. So thank you for choosing that charity to support. And thank you again so much for being here. This has been a wonderful conversation. [00:29:36] Roy Morgan: It's been my pleasure, Lindsey, and I wish you and all your team there a wonderful 2024. [00:29:42] Lindsey Dinneen: Thank you. And thank you also to our listeners for tuning in. And if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two, and we will catch you next time. [00:29:55] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Annmarie Ison, Vice President and Head of Service at Elekta, share her remarkable career focusing on life-saving medical technology. Annmarie reflects on her initial aspiration to be a doctor, her pivot to physics, and the serendipitous turn that led her to a startup revolutionizing radiation oncology. With a personal touch, she shares insights from her childhood fascination with science, her transition from aerospace to the dynamic world of Silicon Valley startups, and her commitment to improving patient care through technology. The conversation not only showcases Annmarie's technical expertise but also her deep passion for making a tangible difference in people's lives. Guest links: https://www.elekta.com/ | https://www.elekta.com/products/oncology-informatics/elekta-one/ Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 029 - Annmarie Ison [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. [00:00:50] Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host Lindsey, and I am so excited to introduce you to my guest today, Annmarie Ison. Annmarie serves as the Vice President and Head of Service at Elekta. With over 25 years of experience as a software development professional, Annmarie specializes in product development and software architecture for information management systems and radiation therapy delivery devices, specializing in software, inter connectivity, machine functionality, and clinical workflow. She is highly effective and directing all aspects of the software development life cycle. And is passionate about new technology, customer relations, and products that have the potential to enhance the standard of care in oncology. [00:01:37] Welcome to the show, and thank you so much for being here. [00:01:41] Annmarie Ison: Oh, thanks for having me, Lindsey. I'm really excited to be here and chat with you and see where this goes. [00:01:49] Lindsey Dinneen: Absolutely. Well, I would love, if you wouldn't mind starting by telling us just a little bit about yourself and maybe your current role. [00:01:58] Annmarie Ison: So my current role is Head of Service for the software products at Elekta. And these products support radiation therapy and medical oncology and for clinics to deliver therapy, both chemo and radiation therapy, in a more efficient, safe, and effective manner. I actually for many years was in engineering and this role in service is fairly new to me. It's only been about a year that I've been in this role. I sometimes wonder how I got here, but I think it really comes from the fact that I love interacting with customers. [00:02:42] I started with the company as a startup, and there were only about 20, 25 people when I joined. And so you did a little bit of everything. And one of the things that got me really excited was working with our customers, talking to them, finding out what they need, why they need it, what they're doing. And also occasionally having those uncomfortable conversations on why things aren't working and how we can make 'em better and how we can fix stuff. And so I think over the years I've done different, as I said, different roles. [00:03:22] I did some product management and went back to engineering again, and then recently took on this challenge of service because, yeah, I just love interacting with the customer for good and for bad, and I really want to help them be better, help us be better by helping them be better and do their jobs in a easier way so that they can focus more time on the patients and less time on the stuff that they have to do. The computer systems are everywhere. We all have to use 'em, right? We have email and we have everything. And I don't want our software products to be burdensome to them. I want them to be easy and streamlined and make their life easier, and again, so that they can make the patient's lives easier. [00:04:19] Lindsey Dinneen: I love that. Oh, thank you so much for sharing a little bit about yeah, your story and how you ended up in this new role. This sounds like a wonderful blend because you have this, I can already tell, this heart for other people making a difference. And then you have that combined with your love of people and your enjoyment with working with them and that's not always easy. So I love the fact that you're able to combine some of those passions. And I'm curious, how did you start getting involved with the company at the beginning, when it was first a startup? How did that all come out? [00:04:58] Annmarie Ison: That was really just by happenstance. I'm gonna go back even further and say, as a child, as a kid, nine, 10 years old, I loved science. I was always into science. I had experiments. I had a chemistry set in my bedroom. But I always just assumed that I would be a doctor. And I, it wasn't, this is gonna sound really weird. It wasn't that I wanted to be a doctor. I just assumed that's what one did. If you were good in science, you became a doctor. That's, that was the only path, and I really never gave my career choice-- it wasn't a choice, actually. It was the only path. [00:05:40] I never really gave it much thought until I got to college and of course I was pre-med and I started meeting my new classmates and talking with them about what, why they wanted to be a doctor, why they were drawn to the practice of medicine. And I realized really quickly that I wasn't, that wasn't me. That isn't what I wanted to do. I didn't have that-- I didn't aspire to practice medicine. And so I kind of pivoted and I went away from that completely and I studied physics. And I focused on physics. And to me, I picked physics because to me it's foundational. And plus, physicists have the best toys. We get to play with all sorts of cool things. [00:06:26] But to me it was foundational and it really helps you understand a lot of other disciplines, and at the same time I was into mathematics and other staff and-- this was many years ago, for those younger folks listening-- computer science as a degree, as we know it today, didn't actually exist back then, or at least not at a lot of universities, and certainly not the small liberal arts college that I went to. And the, but the courses around computer science were taught outta both the physics and mathematics departments, and so I was really fortunate to have these great professors who were, I consider on the forefront, at least to me, they were on the forefront of figuring out how to use computers, and I'll really say PCs, as a tool to connect the physical world and the digital world, and use it to do the things that computers are really good at and let humans do what humans are good at. [00:07:35] And, you could focus on the physical situation and the data collection and data analysis was all done by the tools that we take advantage of or take for granted today. Excel and things like that didn't exist back then. It's a long time ago. So anyway, it, kind of pivoted away from that, from healthcare and being a doctor altogether and focused on physics, went to graduate school. And when I left graduate school, I really wanted to do exciting things like pay rent and eat. [00:08:09] So I found myself in aerospace and it was really interesting. I, I also found myself in Silicon Valley. I met my husband who grew up there, so that's where we wound up, and in aerospace I had, like I said, it was a cool job. I liked it. I was working on satellites. I, GPS was kind of a new thing then. It was really just coming into its own. And I even got to work bit on the space shuttle, so I, I was very excited. I was happy to stay in that role, but unfortunately the job moved out of the Bay Area and I had found myself going what do I wanna do with my life now? [00:08:58] But there were so many exciting things happening in Silicon Valley at the time that I I mean, it looked, it felt like there was a startup on every corner or really in every garage, right? And I just really, by happenstance, found this startup. And during my discussions with 'em, I met the principals and they shared their vision with me and it just resonated. They were working to change the face and the trajectory of radiation oncology, and when they explained their vision, I saw it, and I also saw a path to get to that vision. [00:09:48] Even more so, I felt like I saw how I could bring everything that I had done up to this point-- my physics background because there's a lot of physics in radiation oncology, my safety background for man's space flight, and my desire to do good and help people from when I was a little girl thinking about being a doctor-- I was able to bring all of that together into this one job. And I'm gonna say I was hooked and I haven't looked back. I've been doing, I've been with the company aiming for that vision really for the last 29 years. And I'm still striving for that vision because it really was a visionary that we're not quite there yet. There were paradigm shifts along the way, and we hit those and helped change how things are done and really form a market, but we're still striving. We're still striving to do better. [00:10:48] Lindsey Dinneen: Yeah. Yeah. Thank you. Thank you for sharing about that background. I love how, I just love when a pathway isn't, isn't as straight as we necessarily think it's gonna be. It's kind of funny how, you said looking back, it was almost like this expectation of, I'll be a doctor. And then you were able to, yeah, to take your interest in science, but your interest in lots of other things as well, and then form this career path that's probably looked unexpected, but seems to have wound you up in a place that you feel at home? [00:11:23] Annmarie Ison: Yeah totally. I do feel at home and sometimes I wanna go back to that nine, 10 year old self and go, "see, see, there isn't one path, there are options." There are so many different people and disciplines and viewpoints and technologies that are all needed to change healthcare, to advance the standard of care and the standard of practice. And you can make that difference by bringing your own set of skills, your own viewpoints, your own passion, and by just being you. And I hope that people hear that and realize that there isn't one path. [00:12:06] Lindsey Dinneen: Yes. . Thank you. I am completely in agreement with you, but I also just appreciate that, that you shared that particular advice because I think you're absolutely right. There are always multiple avenues to a dream and what might work for one person might be a different path for someone else. Well, so are there any moments that stand out in particular as just having this moment of realization that you are where you're supposed to be, like you're in this field, you're at this company, you're doing this particular work. Just any, anything that stands out in particular as, "Yes I am, I am in the right place at the right time." [00:12:51] Annmarie Ison: Oh goodness. I mean there, it's been a long career. So there are so many things that I'm proud of, but there's a moment that sticks in my head from many years ago. Maybe about two or three years after I joined the company, there was a new forum, a new technique in radiation therapy that was trying to become --I'm gonna just call it mainstream or standard clinical practice-- but there was a challenge there that the amount of data that was involved in preparing the patients for the treatment was huge. Hundreds, thousands of pieces of data that the medical physics team had to check and recheck and do measurements on. And it took a lot of effort and we were working with some of our customers to tried to streamline that process and provide them the confidence. Some of these checks, again, people can do those checks, but computers can do those checks really fast. And so we were working with a number of customers and there was one night, and like I said, it sticks in my head. I was in a, can I say I was in a bar in Saddlebrook, New Jersey of all places? [00:14:06] Lindsey Dinneen: Of course. [00:14:07] Annmarie Ison: You're up in New Jersey, so maybe that's why it sticks out. But where I was talking with a colleague, a customer, and we were gonna give a seminar the next day, and he had just, he was putting his slides together and going over them with me, and he had told us that he was able to get this effort that took him like 30 to 40 hours down to about an hour, and we were like, "Wow, that's awesome. That's fantastic." And we were really excited about that. But it was the thing that he said next that really stuck with me. And there's two points on it. The first is he said, "And now we don't have to choose. If the clinical indication requires this kind of treatment, we can offer it." [00:14:54] And that just hit me and I was like, "Wow, we moved the needle. Right? We really moved the needle." And I just, I was really excited about that statement, but it also hit me in a slightly different way. It reminded me that in all the rush to, in the day-to-day responsibilities of getting these features to the market, and who has to sign what paper, and what form has to be done, and what project plan has to be completed, and all those things that I actually didn't think about the patient. I'd forgotten about the patient. [00:15:35] And really since that day-- I actually felt bad about myself when he said it. I was frustrated and angry at myself for not thinking, not keeping that patient and that set of patients in mind-- that really since then, every day I think about the millions of patients that are impacted by the products that we work on. And I also think about each individual patient. When I'm never sure about, "Is this the right thing we should do? Are we working on the right thing? Is it good enough?" I think about the patient, the individual who could be anyone. It could be your brother, your sister, your spouse, your next door neighbor, child as well as I think about that vast set of patients that can be impacted. [00:16:24] And it helps recenter me and refocus me to make sure that I know I'm doing the right thing. And it's just stuck with me all those years. I'm a little bit of a broken record at work when I say, "Two and a half million patients, two and a half million patients," , or I say, "What about the patient? What about the patient?" But, I think in the end, it serves us well to do that, to always keep that in mind. [00:16:52] Lindsey Dinneen: Yes, absolutely. And, thank you so much for sharing that story. That's powerful. And so I know that women's health and advocacy for femtech, whatnot, that's something that you are interested in and passionate about. And I was wondering if you could share just a little bit about maybe your experience. [00:17:13] [00:17:14] Annmarie Ison: Yeah, so I think that access to care is really the key thing. And, whether it's women's health-- which I think is a huge issue of getting access to care-- but it can be anyone really. As I mentioned in the previous discussion about bringing these advanced techniques to the clinical setting, there are areas of the world that, that don't have the resources. And the resources could be basics like electricity and access to power and things like that. But also, the resources of skills. Right? [00:17:56] As I mentioned, medical physics is a big part of radiation therapy and if you don't have really skilled medical physicists around, it can be difficult to use these really advanced techniques that can, provide better care, fewer side effects, shorter treatment times. Again, when if you're looking at someone who has to travel a long way to get to care, you don't want them to have to come back every day for 25 or so days. If you can shorten that down into a week or so, which we can with some of these really advanced techniques. [00:18:35] But again, you need those resources, you need those expertise, and I think that's where I. The digital world comes into play again. And if anything, the pandemic taught us that we can do so much remotely. I can be, and we have this already today, can have medical physicists from some of the leading clinics in the world, here in the United States as well as in Europe, looking at and supporting countries that don't have that same baseline of resources and technical expertise. [00:19:10] And I think, women's health comes into play there a lot in that there are many indications in that are managed by radiation therapy. So I think, again, being able to offer these advanced techniques, shorter timelines, hopefully higher cure rates, or at least control rates, to these emerging markets, and expand access to care is really important to me. And I feel that's the direction that we have to go with in the, in healthcare in general. Access to care is the key. [00:19:47] Lindsey Dinneen: Yeah. Yeah. Thank you for speaking to that and elaborating a little bit on, on that, and I, I, I appreciate the fact that that you and your company in particular are aware of those issues and are thinking through them and talking about them and, that's how change is gonna happen. So, it's always exciting to see that. [00:20:08] Annmarie Ison: Yes. [00:20:09] Lindsey Dinneen: Yeah, absolutely. So, pivoting the conversation, just for fun. Imagine someone were to offer you a million dollars to teach a masterclass on anything you want. It could be within your industry, but it doesn't have to be. What would you choose to teach about and why? [00:20:30] Annmarie Ison: Oh my goodness. I think fundamentally I have a hard time with this question because I don't consider myself a master of anything. I always consider myself an intermediate, because as I learn, I realize how much more I don't understand about them. But for the million dollars, and I'll take it, I think it would have to be something around cooking. I love to cook, but I wouldn't want to talk about technique, mastering a specific chopping technique or sauteing technique or whatever. But I think I'd call it "collaborative cooking." I have so many friends who are intimidated by cooking and, "Oh, I don't know how to cook. I don't have a recipe." But I just can't think of anything more fun than to work as a team, bring everyone's different perspectives and skillsets and passions, if you wanna use that word, together, to bring a nice meal on the table and if things go wrong, well, that's part of the experience. [00:21:38] I also think that if you don't cook and you can still be a part of the team. My, my family does this, my family and friends, we do this all the time. Someone, we have three or four people in the kitchen, all cooking together. Someone made the menu, someone else has picked the wine, someone setting the table. Hopefully someone's pouring the wine too, but we all come together and it makes everything less, like I said, intimidating. You don't, you shouldn't be intimidated by cooking. It's fun and there's nothing better than enjoying a nice meal prepared by all of us together. [00:22:16] And that's my feeling about a team also is when you have a team working with food, like I said, dinner, it's no one's thing. It's everybody's thing. We all came together to make it so it's no longer, "I cooked this." It's, " We cooked this, we did this, and we made this wonderful evening or afternoon or whenever it is." You're enjoying it. So that would be my theme of the masterclass, if I could. [00:22:50] Lindsey Dinneen: I love that. Oh, I love that. [00:22:52] Annmarie Ison: Yeah, just, cooking with my nieces and nephews is always fun, and everyone coming together to enjoy and celebrate. [00:23:01] Lindsey Dinneen: Yes. . Yes, that is very exciting. And hopefully, like you said, the, the teamwork component of it will be joyful as all the families get together . [00:23:11] Annmarie Ison: It can also be, I call it, "passionate." It can be . It can also be passionate at times, like... [00:23:19] Lindsey Dinneen: I love it. [00:23:20] Annmarie Ison: ...someone can feel strongly about the temperature that cookie should be cooked at. I don't know. [00:23:25] Lindsey Dinneen: Yeah, that's right. And we're all working together towards a common goal, so gotta figure it out. . Amazing. Amazing. How do you wish to be remembered after you leave this world? [00:23:38] Annmarie Ison: This question, I'm gonna have a hard time with answering without getting very emotional. My husband passed away a few years ago, and he was in medical devices as well. We actually have a very similar background, he was a physicist, went into medical devices and we actually talked about this when we knew the end was nearing. And his answer was, "I want to be remembered that I helped." And I can't think of a better answer. I would love to be remembered that way, that I helped in some way, in all sorts of ways, that I helped my family and friends in times when they needed help, whatever that was, might be cooking something for them. But also that I helped forward this vision that the founders of the company had that I helped clinicians help their patients, and that I had some small impact on the standard of care and the direction of oncology. Yeah, that's the way I would like to be remembered, that there was some help. I can't think of anything better than that. [00:24:51] Lindsey Dinneen: Yeah. That's beautiful. That's a wonderful thing to aspire to. Thank you for sharing those stories, really appreciate it. And last but not least, what is one thing that makes you smile every time you see or think about it? [00:25:07] Annmarie Ison: Oh man. I feel like I should say something honorable like my family and friends and things like that, but they would all know that I was lying if I said that. They know the answer. The answer is pandas. [00:25:25] Lindsey Dinneen: Yes. [00:25:27] Annmarie Ison: I love pandas. As a little girl, I had a stuffed panda instead of a teddy bear, and I became a bit obsessed, and I consider myself now a recovering panda- holic. I had a rough week when the pandas left The National Zoo. It was very emotional for me, but I still lean towards pandas. I can't help but smile and laugh when I see them, and if you were to look under my desk on my early morning teams calls, chances are that I'm wearing my big fuzzy panda slippers while I'm taking those morning meetings. [00:26:09] Lindsey Dinneen: Oh. [00:26:09] Annmarie Ison: You dunno that, but I've got my big fuzzy panda slippers on most days. [00:26:15] Lindsey Dinneen: I love it! Thank you so much for sharing that. That just makes me smile. I love pandas, oh my word, and I just, every time I see those videos of those care takers trying wrangle the babies, oh my goodness. I love it. [00:26:34] Annmarie Ison: I, I, if I wasn't doing what I was doing and helping people this way, I, that's my dream job. [00:26:40] Lindsey Dinneen: Yeah. I have often said my retirement gig is gonna be a animal caretaking in some way. Oh my word. Well, this has been such a pleasure to speak with you today, Annmarie. I really appreciate you sharing a little bit about yourself and your background, how you came into this industry, and just your heart and passion for people, and making a difference. I really commend you and I just I thank you. Thank you for everything that you're doing to change lives for a better world. [00:27:10] Annmarie Ison: Oh, thank you. Thank you for having me. And I've actually listened to a number of your podcasts, so I feel honored to be a part of the group that you've talked to. And thanks. Thanks for inviting me here. I really enjoyed it. [00:27:24] Lindsey Dinneen: Thank you so much and thank you so much also to all of our listeners, and if you're feeling as inspired as I am right now, I would love it if you would share this episode with a colleague or two and we'll catch you next time. [00:27:39] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development. ​  

Essa Abdool-Karim, an emerging companies lawyer specializing in medical technology, shares his intriguing journey from sports and entertainment law to finance law, before finding his passion in MedTech legal affairs. He discusses the vital role of contracts, liability considerations, and the complexities of navigating regulatory landscapes, especially when expanding into international markets. Essa offers invaluable insights into the importance of strategic investor relationships and the distinction between "smart money" and "dumb money." His optimistic outlook and dedication to facilitating breakthroughs in MedTech make this a must-listen for aspiring and established entrepreneurs. Guest links: https://www.linkedin.com/in/essa-abdool-karim/ Charity supported: Sleep in Heavenly Peace Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 028 - Essa Abdool-Karim [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. [00:00:50] Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host Lindsey and I am so excited to introduce my guest today, Essa Abdool-Karim. Essa is an emerging companies lawyer who helps his clients build their businesses. This can be through raising capital, producing the correct contracts or structures, navigating regulatory hurdles, or purchasing new businesses that will either expand or open a new market for their current businesses. [00:01:17] Essa, welcome to the show and thank you so much for being here. [00:01:21] Essa Abdool-Karim: Thank you for having me. [00:01:23] Lindsey Dinneen: Absolutely. I'd love if you wouldn't mind starting off by telling us a little bit about yourself and your background. [00:01:30] Essa Abdool-Karim: Yeah. So a little bit about myself. I am an emerging company's lawyer, some would say a venture capital lawyer as well. I, I have sort of like a general practice, but my emphasis are in several technology companies, but I have a special interest in medical technology companies, representing them from their early sort of incubation stages all the way up into hopefully one day, some IPO or other form of exit. And a lot of my practice is helping sort of build that out and almost acting as fractional general counsel to a lot of the activities that they do. [00:02:03] Lindsey Dinneen: Excellent. And then would you mind telling us a little bit about your background, maybe how you got into this field and specialty in the first place? [00:02:11] Essa Abdool-Karim: Yeah, my journey is quite interesting actually. It is not, it's not a straight line by any means, right? So, I actually started as a, so after I finished law school, I went and worked for sports and entertainment law firm where I was representing athletes, entertainers, at sort of international tribunals and contracts sort of negotiations, mediations. There was contract drafting as well. So it was really cool. It was a lot of fun and I don't know what possessed me to say, "Hey, I want to go leave this and go to the exciting world of finance." [00:02:41] So I ended up in the the finance industry. I worked for an broker dealer in Montreal. So I did sort of a quasi-legal role there. But at some point I just missed private practice. So I left, ended up starting my own shop and then joining up with the firm I'm currently with. And yeah, so as I was developing my practice, I realized that I loved working with startup companies and growth companies or companies in a growth stage. I found it to be very exciting. [00:03:11] How the medical technology thing sort of happened. It sort of lined up with my interest and I had one client that sort of reached out to me that was sort of a larger, they had a more established medical technology company than they all also had an early stage medical technology company. They had a couple. And it sort of through that, I really sort of delved into the world of medical technology and all of the legal issues that these companies typically face, both in local markets and international markets. Prior to that, however, I've always been interested in the space. I just didn't know exactly what the space was or meant. Right? So yeah, that's that's a bit of background about me and sort of how I ended up where I'm now. [00:03:51] Lindsey Dinneen: Yeah. And so out of curiosity, did you growing up think, "oh my goodness. One day I'm gonna be a lawyer?" Like, was this always a goal and interest of yours or has that evolved over time? [00:04:03] Essa Abdool-Karim: Yeah, weird. It's kind of weird how that happened. Law has always been sort of something of interest to me and from a very young age. And it is something that I've often entertained. I did wanna do something a little bit different, but it was like, "oh, it would be nice to be like a marine biologist. What do they do? It'd be nice to be an astronomer, but I do just look at the stars all day?" I'm not sure, right, what that sort of entails. So I was like, "okay, I understand what lawyers do, I think for the most part. So I'll just do that". So, yeah, how that happened. [00:04:32] Lindsey Dinneen: Okay, . Okay. So, so first was just sort of, okay, I have an idea of what you do, but then, I mean, that's a huge commitment in terms of education and time and all sorts of things. So, how has becoming a lawyer and then going from sort of industry to industry, how has that been a compelling thing in your life in terms of career trajectory as you've gone from one industry to another? [00:05:00] Essa Abdool-Karim: Yeah, Yeah, Yeah it's been interesting. I kind of like it personally just because when I first started, and even a little bit right now, I'm sort of industry agnostic. I wouldn't have been where I am today, if not for the journey that I've had. I kind of done everything that I wanted to do. Like prior to law school, I taught, I was a teacher because it was always like, maybe I should become a teacher. Then I went to law school, wanted to work in sports entertainment. I think every entry class has about 30% of the students want to enter into that. I was very fortunate that I ended up in there. So, and then I went, I've always wanted to try the world of finance. I tried that, got to see what that was about. It was interesting. Not interesting enough for me to stay, but interesting, so. [00:05:43] Lindsey Dinneen: Sure. [00:05:43] Essa Abdool-Karim: So it was, it's good. It's been a very good journey in that regard. And I'm just happy that I ended up dealing with medical technology as one of my major verticals. So that's been, it's been really cool and I've been very fortuitous to have that experience, and it's exciting. I enjoy the pace of it. [00:06:01] Lindsey Dinneen: Yeah, for sure. So with medical device companies in particular, I imagine that each industry, and of course each company has different focus points in terms of legal considerations, but MedTech is a very heavily regulated industry, so what are some of the top considerations that you help-- especially very young startups, maybe it's their very first invention or product-- what are some of the considerations that you always help them to think through from a legal perspective? [00:06:35] Essa Abdool-Karim: It's a loaded question and I don't wanna, don't wanna. No, it's a very loaded question. It's a good question though. I don't wanna give you the lawyerly answer and say it depends but in, in a way it does, but I think the essentials are, there's, there's a few. [00:06:50] So, you know, contracts are very important. Obviously having the right contracts in place is, there's a very good starting point, especially with your founders. You, everyone sort of starts your relationship thinking, oh, this is sort of like a "kumbaya kind a moment. We're all gonna be fine. Everything's gonna work out." But the reality is, you know, I'm not paid to think about the kumbaya moments. I'm paid to think about, you know, what's the worst that can possibly happen and how do we account for that, unfortunately, right? So that's one thing that's very important. Understanding where everyone's responsibilities are, outlining that in a document is a very good starting point. [00:07:22] The other critical starting point I would say is liability, particularly in the medical technology industry. It's a highly regulated industry. There's a lot of money flowing around, and with that, there's a ton of risk. So, as an example for Canadian companies they will be receiving any sort of regulatory approvals that you need to receive from the relevant Canadian authorities. And once you obtain that, you have it, you're in the market, but more often than not, you're looking to expand to the United States, as an example. [00:07:54] Now there are a number of considerations when you're having to do that. There's obviously FDA regulations that you have to worry about, certain sort of disclosures that are required to be made. And this isn't even going into the intellectual property element of patents and other sort of important intellectual property issues. But just both focusing right now on the corporate side. When, and I'll speak from a Canadian perspective and I'll transition into the US, but when a Canadian looks at the US the, they're, the biggest thing they're afraid of is getting sued and understandably so. The United States is the most litigious society on earth in the entire world. I think I saw a statistic where it said there's a lawsuit literally every second. And. [00:08:38] Lindsey Dinneen: Oh my word. [00:08:39] Essa Abdool-Karim: Yeah, so it's understandable. There's a high risk, high reward because the United States is such a large market, and there's so much promise here, people want to enter into it, but they wanna be very careful when entering into it. And I typically advise them the relevant corporate structure to enter in to this market for it. Now there's a distinction, right? There's the early stage elements where we're dealing with startups, making sure the contract correct contracts are in place. There is a basic corporate structure in place. And you're working towards some sort of intellectual property ownership because that's critically important, particularly in this field, although I'm not an intellectual property lawyer. [00:09:17] I do, I shouldn't say-- I'm not a patent lawyer. I do some intellectual property work. I'm not a patent lawyer specifically. You know, I'm familiarized with trademarks, copyrights, but patents that are very sort of technical area of law. But it's critically important to have your eye on the prize and want to work towards that. So I do liaise with patent agents, patent attorneys and other relevant legal minds. So that's all part of the process. [00:09:45] I think building your vision very early, understanding how you want to get there and where you want to go is all critical and part of the process. In my experience, patents take a very long time relatively to secure, but I think that's the end goal. And even with that, there's time limit after you obtain it to, to file for it in other countries. So it becomes a global thing as well. But yeah, so at the early stage you wanna work primarily on the structuring, get the right team together, make sure that everyone has the right documents in place. Could be employment agreements, could be independent contractor agreements. [00:10:15] It depends on how you wanna structure your company, how much appetite you have for it, what's your relationship with the employees or independent contracts ought to be. anD even the boring stuff like share classes, understanding how those work. And then there's raising money, and that's a big one because everybody needs money to operate their company, and to get it off the ground. So those are some of the early stage considerations. When you're sort of like at a growth stage, what you're looking at is market entry, how to enter into foreign markets, which obviously I help my clients with as well. [00:10:48] Lindsey Dinneen: Yeah, so lots of considerations. So we can just barely scratch the surface, and folks should hire you if they need additional supports. [00:10:56] Essa Abdool-Karim: For sure. [00:10:58] Lindsey Dinneen: You know, it's so interesting. Thank you for sharing some of those considerations and bringing to light some things that you might not think of initially, especially like you mentioned, it, it does feel very exciting when you start a company and you have all of these like celebratory moments, 'cause everything is exciting and a big deal. And then like you said, but you have to think it is your job to think about what could go wrong though, and then prepare for that. So I am curious though, that sparked a question for you personally in your own life, how are you able to separate or negotiate the fact that a lot of what you need to do is look for worst case scenario, when probably you wouldn't wanna do that in your personal life all of the time. So I'm curious how that works where it's like your work is so heavily focused on being proactive in a preventive way, however, at the same time, for you personally, how do you balance that? [00:12:00] Essa Abdool-Karim: Yeah. Yeah, it's interesting. It's a good question too because we have... listen, I'll be honest with you, lawyers are pessimistic by nature, right? I think generally speaking, we just think of the worst case scenario. I'm not like that personally. I'm an optimist. I'm a cautious optimist, a realistic optimist, whatever you wanna call it, right? My philosophy is always hope for the best, but prepare for the worst. I think it's critically important to do that. I do that in my personal life. I do it in my professional life. And just because you're thinking of the worst case scenario, it doesn't mean it's gonna happen, right? You just have to calculate for it. My job is to make sure we don't get to that point, right? But you have to account for it nonetheless. [00:12:39] Lindsey Dinneen: Yeah. So, so you are able to keep the perspective of we're doing this as a, as something to be prepared for as a preventative and not get to that point, so therefore it can be a little bit more optimistic and a little less... [00:12:54] Essa Abdool-Karim: Yeah, and it's so difficult. It's so difficult too, to be honest with you, just because so much of my job is, you know, thinking about that stuff, [00:13:04] Lindsey Dinneen: Yeah. [00:13:04] Essa Abdool-Karim: It's very easy to get down on yourself outside of work. So you need to be really good at sort of detaching. And I have a good support system in place. I think that's very important. I didn't marry a lawyer. I know a lot of people that do, like lawyers marry other lawyers. So I think the fact that I'm not married to one probably helps. [00:13:21] Lindsey Dinneen: Yeah. [00:13:23] Essa Abdool-Karim: I know me if I was married to one, we just bought talk shop when I got home. So, and I know a lot of lawyers that are married to other lawyers and it works for them. I think they probably make it a point to probably detach and they probably understand each other in, in that sort of capacity. But I'm married to an accountant, so very different world and I think is beneficial for me. [00:13:45] Lindsey Dinneen: Yeah, that makes a lot of sense. . Yeah. So with the medtech industry specifically-- when you do get to work with those clients, what are some of the things that stand out to you as being particularly noteworthy or enjoyable? What in particular do you like about this industry? [00:14:04] Essa Abdool-Karim: Oh, I love how brilliant everyone is. Everyone is so smart, so much smarter than I am. Like it's It's amazing. [00:14:11] Lindsey Dinneen: Yeah, [00:14:12] Essa Abdool-Karim: It's [00:14:12] Lindsey Dinneen: I get that. [00:14:13] Essa Abdool-Karim: It's really cool. It, there's so many smart people in this industry. Watching, not only watching, but also being in that room with people who are trying to solve a problem makes such a massive difference because I feel it pulls myself up as well. I really have to be on my A game. And because of that, it's just so enjoyable working with them. So yeah, definitely. It's definitely the intelligence. That's one thing. [00:14:37] Another sort of element is-- and I went to law school with this intention-- I always wanted to be able to provide for my family, but I always wanted to do good. I wanted to be able to sleep at night and knowing that I was doing good. And, when I'm servicing medical technology companies, I know, yeah, obviously you have to care about the bottom line. That's, that's part of the business side of it. But a lot of the founders I met their intentions aren't just the bottom line. [00:14:59] Their intentions are, we wanna change the world for better and we want to make the world a better place. We want to make it easier for, for everyone who's going through this particular difficulty and we want to make their life easier. And I think that's remarkable. So one of the greatest pleasures I have is I'm trying to help 'em achieve that goal and I'm trying to help them realize that success and that is really cool for me. [00:15:22] Lindsey Dinneen: Yeah. Yeah, absolutely. Yeah. Thank you for sharing that. I think those two things are-- I agree with both of them. I really enjoy both those elements. I also really like-- I don't know what your experience has been-- but one thing that I very much enjoy about the industry is how friendly people tend to be, and they tend to be just very welcoming. And us about you, tell us, you know, it is, it's just a very inclusive place for the most part. And I hope it will continue down that pathway because [00:15:47] Essa Abdool-Karim: I think, yeah, I for sure. I think the people I've met are very receptive, and that's, and I think that's really cool. Typically, and I'll be honest with you, in some industries there's almost, I wanna call it a fraternity, where they try to keep people out. But I haven't found that in the medical technology industry. I found that people are very receptive, very open, and I think the worldview actually is a little bit different from other industries in that sense. There's very human side to this that I think everyone appreciates. And I think that's really cool. [00:16:18] Lindsey Dinneen: Yeah. Yeah, absolutely. And so, are there any moments along your lawyerly journey where you had this realization, maybe you were helping a client, or it could really could be anything, where you just had this thought of, wow, this is why I do what I do. [00:16:38] Essa Abdool-Karim: Yeah, that's a very good question. There's a really basic one I had recently a couple of months ago. So I drafted up an independent contractor agreement for a client and things didn't work out. Independent contractor got upset. They parted ways. Independent contractor comes back threatening to sue. Client goes, "Hey, look at the contracts. You can't do that." And I was like, "yeah I drafted that. So this is what I do. Okay, cool. So there's purpose to my job and the work I do." So that was, so that was good. That was a full circle moment. That was really cool. [00:17:16] Lindsey Dinneen: Yeah, exactly. Seeing it in real time, the protections that you've put in place, actually helping your clients, which of course you want them to, but if they're not tested... there you go. [00:17:27] Essa Abdool-Karim: For sure. And when, and one of the other, one of the other things I think that was really cool recently was one of my clients launched in in another jurisdiction. And I helped set that up and knowing that, and I've seen testimonies about the product and the treatments that the clients were receiving, and to be a part of that is really something special. [00:17:44] Lindsey Dinneen: Yes. Yes. Absolutely agree. Absolutely. Yeah. And so, coming down the line, what are some of your things that you're looking forward to with with your firm, with your clients, or, you know, continuing to expand? What are some things to look forward to? [00:18:00] Essa Abdool-Karim: Yeah, it's it's an exciting time for me just because I'm expanding my, my practice a little bit in the sense that I'm really digging into sort of medical technology community, even to an extent the health tech community. So it's exciting for me because I'm moving in that direction. And I'm really doubling down on helping my clients open up their companies into international markets. So that's been really exciting. We do quite a bit of work in the Middle East, for example. But I. The United States for a lot of people is a big, a big market. So expansion here is very important, and even for US clients, expanding outwards is still really good for simply diversifying your portfolio. And there's many companies that do this. [00:18:40] The Canadian market is really good for that as well because we do have a robust economy. We do have a good set of regulations in place. Market entry is a little bit difficult because of the regulations, but we have a very sophisticated consumer market and a very good infrastructure, which is the appeal of Canada, which is something I didn't realize until earlier this year, I, in my mind it was, why come to Canada when you can go to the US, right? And it still very much is the case. And if you just look at the consumer market, ours is smaller naturally. The US has, I think, the second largest consumer market in the world behind China. So, makes sense why companies would wanna open up in the US over Canada. But for us, companies that are already established here, I think it's a very good move for them to establish themselves in Canada, just because there is a very sophisticated user base and consumer base for the products that you would launch there. [00:19:30] Lindsey Dinneen: Yeah, so continuing to expand even more into helping those clients as they look towards more global reach essentially. And yeah, continuing to build up that medtech portfolio. That sounds good. [00:19:44] Essa Abdool-Karim: Yeah. Yeah. And it's a lot of fun, again, just because of the people you meet. Super, super exciting. I mean, there's been. There's been there's so many anecdotal stories. There's a saying amongst lawyers, we'll do everything for you. Just give us the book rights, right? Waive-- your story is so phenomenal-- just waive your book rights, so when, you know, at the end of my career, I can put it in my book and tell people about it, sort of thing, right? Because we do a lot of that and... [00:20:08] Lindsey Dinneen: Right. [00:20:09] Essa Abdool-Karim: Some of the stories we see are truly sort of remarkable. And a lot what we do, it's kind of sad, but funny at the same time because like my, one of my mentors says, and one of the principal lawyers in my firm, he says, "Listen, they're either gonna get us on the way in or the way out. You know, one way or another, you're gonna need us. Either when you're starting the company, you're gonna hire us or you're gonna make a mistake down the line and you're gonna need us down the line." And unfortunately, I've seen the latter situation where down the line things have gotten really bad. And have you had just spent a little money upfront, this wouldn't have cost you a million dollars later on. And that has, and it has happened. I've seen it happen firsthand and it's super unfortunate. [00:20:47] Lindsey Dinneen: Yeah, so in general, I it, I'm not putting words into your mouth, but it sounds like one of the first things if you establish your own company is to consult with a lawyer. [00:20:57] Essa Abdool-Karim: I think so. I think I, I think as far as... and obviously I have my bias here, but you know... [00:21:03] Lindsey Dinneen: Sure. [00:21:03] Essa Abdool-Karim: Again, I've seen, I've, I've seen companies, that started barely anything, right? And they built into this thing that they never thought they'd be, like this massive company. And not to say that they never wanted to reach that point, or they never wanted to get to that point, but it grew into something that they never thought, even dreamed possible, right, in a very good way. The problems, the foundational documents and the relationships they had with maybe vendors or licensees, weren't the best in nature. And then I have to come in and I'm doing crisis management at this point. I'm either managing their litigation or if I'm not managing their litigation, I'm trying to diffuse the situation so it doesn't get worse, could be through mediations and out of court discussions, right? Even though I'm not a litigator, I do this sort of litigation management. All that to say in long-winded way of answering your question is, yes, please consult a lawyer as early as you possibly can, as early as you can afford it. [00:22:00] You want to be able to resolve issues before they get to court, generally, right? When you're not the offensive side, but even when you are suing, right? Because obviously if you have a patent interest in something or someone's infringing on your patents or you know, maybe there's a commercial disagreement. Even if you are the party suing, you have to be very careful when going to court. And the reason for that is you cannot tell who the judge is gonna be and how they're gonna view things. It's always, you always throw the ball up in the air. [00:22:29] You know, even we as lawyers, we can do as much case law research as we want. We can look at the legislation as hard as we want. We can really scrutinize it. We can go into the wording, we can make our arguments, but we cannot guarantee that things will end up in your favor even if you have a really strong case. Because when you go into court, anything can happen. From witnesses to, to, to the judge's opinion, maybe their own personal experience in something, you don't know. So even in that situation, it often is better to settle outside of court or have some sort of discussion. But yeah, it's it's an important sort of strategy to note that dispute resolution is a critical part of any legitimate litigation strategy, in my view, at least. [00:23:14] Lindsey Dinneen: Yeah. Yeah, that makes a lot of sense. I absolutely see the value, of course, in that. And then, and like you said if you end up sort of inviting in non-controllable human elements into the mix, if you do end up.... yeah. Yeah. Okay. Yeah. All right. [00:23:32] Essa Abdool-Karim: it's not I think. I think if a lawyer tells you, "This is a slam dunk," you should be very cautious. Yes. I think that's a big, I don't like, maybe it's a red flag. It's definitely like an orange flag. Not even a yellow. It's like an orange flag, right? So you definitely wanna watch out for that because a lawyer's telling you, "oh, this is a slam dunk. This is not a problem." I like, okay, are like, "are you a psychic? Do you know the judge person?" Like, you know what-- there's a lot of things that can go wrong. [00:24:01] And by the way, it's all very expensive to go to court. It is very expensive. And this bothers me 'cause even lawyers are expensive, right? I know this. It's unfortunate because access justice is something very important to me. But the problem is there's a big paywall behind it. So, and it's one of the things a lot of early stage companies struggle with. So how can you get legitimate and valid legal advice when you can't afford it? [00:24:23] So there's actually two ways I have in my mind and I guess I share with you right now. And perhaps your listeners will find value in it. One of them is obviously to join some sort of incubator or accelerator. Those are always good, because the network you can build in them. Even, so one of the other thing is, and perhaps if you'd like, we can talk about investing right after this, you'd be able to connect with, you know, could be venture capitalists, could be angels, but what's important, you open up sort of a new network for yourself in a myriad of different ways. So that's the first element. [00:24:55] The second element, and I posted on this on LinkedIn a couple months ago. It's, you can have an advisor committee where you give maybe one or 2% of your equity or whatever the advisor wants. But you can bring a lawyer onto that advisor committee for equity. That way you're not actually paying liquidable cash for that advice, but you're actually bringing them in to advise you on how to set things up while giving maybe one or 2% of your company away, which maybe a lot, maybe a little, depending on how valuable the lawyer is, but it's a good way to save upfront cost. [00:25:28] Lindsey Dinneen: Those are great suggestions. Thank you for that. That's great advice. And then you mentioned the investing side. Do you wanna talk a little bit more about that too? [00:25:35] Essa Abdool-Karim: Yeah, absolutely. So financing is a difficult thing, right? Because you're very sort of, subservient to the markets in a sense, right? And we're in a little bit of a down market right now, but people are still raising capital. I know people are, that completed about a $50, $60 million raise like about four or five months ago. So, I mean, money is still being moved. [00:25:53] But the sort of important thing here is, and I cannot emphasize this enough, there is an important distinction between smart money and dumb money. And what I mean by that is, it's sounds crazy, but anyone can go out and get money. I, you know, you can go and you get in front of the right person and they'll just give you, they'll write a check for a 300,000, $400,000, whatever, right? The problem is you don't want to just take cash. I mean, you can. But it's not gonna open up a network if that person doesn't have the network that you need. [00:26:24] The smarter way to go about it is to make sure to get it, bring in an investor that can actually open up a network for you, because at some point they might want a board seat and those shouldn't be given away just to anyone. It has to be very strategic. And one of the important things I find is that if you have a very good investor, someone who actually has a market behind them. And since we're talking about the medical technology space, we want someone in that invests into medical technology companies that understands the vertical. Because when they come in they likely already have an ecosystem that you can use. [00:26:57] They might, I don't wanna say have a relationship with the regulators, but they might be familiar with the regulators and maybe familiar with certain professionals that they can introduce you to. They may have in their own portfolio connections to distributors. That could be huge, that could be more valuable than the million dollars they just gave you because it might open up a $10 million market for you, just by virtue of the fact that you got introduced to distributor because of this person's reputation. So you have to scrutinize your investors as much as they scrutinize you. [00:27:24] And I know that's difficult sometimes because obviously there's a huge power dynamic between early stage companies, even growth companies, growth stage companies, and an investor when you're literally might be on fumes and your runway is at its the very end, maybe like a month or two away from giving out. So it's very difficult to sort of stand there and tell them like, "look, you need to open this and this door for me, you to bring me in." Very difficult to put yourself in that position, but that's the position you ideally wanna be in. Connect with someone who can open, open market for you. And I think that's one of the most important things about bringing investors in, [00:28:01] Lindsey Dinneen: Yes. Thank you. That's really great advice and that's the first time I've heard that particular advice, so I really appreciate you sharing that. [00:28:08] Essa Abdool-Karim: You are welcome. [00:28:10] Lindsey Dinneen: Yeah, I think I, that brings a lot of value to when people are looking for those resources. And like you said, maybe the million dollars, I mean, it is cash, it's gonna be useful, but might not be, as you said in the long term, as impactful to your business as those relationships in this context can be. So something to really think about, and take seriously. [00:28:31] Essa Abdool-Karim: It can be very difficult sometimes to remove those investors that have invested into the company that you don't want anymore. And they're just taking up a spot in your cap table... [00:28:42] Lindsey Dinneen: Yeah. [00:28:42] Essa Abdool-Karim: ...with not one really bringing anything. And that's very difficult. And this is one of those other issues, is if you don't have something in writing that allows for you to both parties to sort of set the step away amicably, they'll be stuck on there. [00:28:57] Lindsey Dinneen: Yeah. [00:28:58] Essa Abdool-Karim: And that's happened and I've had sort of like these business divorces that I deal with, which is not fun, but it is sort of part of the game as well. But there are strategies you can employ at a high level without breaking any laws that will help remedy that. But again, situation by situation [00:29:17] Lindsey Dinneen: Absolutely. So you have shared lots of great advice, but I would just say when I summarize it in my mind, one of the biggest things is talk to a lawyer early and often. [00:29:28] Essa Abdool-Karim: Yeah. [00:29:28] Lindsey Dinneen: Yeah, there you go. There you go. Amazing. [00:29:34] Essa Abdool-Karim: Play the long game. You know, make a friend, be like, "Hey listen, you'd make a great lawyer one day" and just kind of push them to law school. Yeah, just push them into law school. [00:29:43] Lindsey Dinneen: And maybe, maybe offer to contribute to the law school tuition a little, just you know. [00:29:48] Essa Abdool-Karim: I just believe in you so much [00:29:53] Lindsey Dinneen: That's amazing. I love it. Pivoting a little bit, just for fun. Imagine you were to be offered a million dollars to teach a masterclass on anything you want. It could be in your field, but it doesn't have to be at all. What would you choose to teach and why? [00:30:10] Essa Abdool-Karim: I think I'd want to teach people how to motivate themselves. I have a background in coaching, coaching sports. So I've always found it and no matter what sort of industry I've been in, what position I've been in I find great value, in, in being able to motivate others. I think it's very important and I find great satisfaction in it. And it's really, it feels really good when you, when you see people becoming successful, perhaps not, I don't wanna say as a result of it, your advice, but partly as a result of your advice or your encouragement. So I would probably put together some sort of masterclass on how to get out of bed in the morning, how to set your goals, how to set your visions, and how to execute on those visions. [00:30:54] Lindsey Dinneen: Yeah, that's a great masterclass and one that I'm sure a lot of people would sign up for, because it's so important. I recently actually listened to just a snippet-- I need to go back and listen to the whole thing-- but of a TED talk where the woman was talking about how we often treat confidence as a" nice to have" instead of a "must have." And what a difference it makes when you do treat it as a must have. And anyway, that I thought of that immediately when you were talking about the motivation and sometimes you need a coach to kind of come alongside you and help with that and say, "Yeah, no, you can do this. Let's figure out how we're gonna do this together." [00:31:31] Essa Abdool-Karim: Yeah, Lindsey, it takes, honestly, it's, it can just be one person, just one person that says, I" believe you can do this." It makes an entire, huge difference. And I don't think some people maybe do realize this, others don't realize how big that can be. [00:31:46] Lindsey Dinneen: Yeah. Yep. Absolutely. And I just kept thinking though, , is a very, that was a very good point and a serious one, but the first thought that popped into my mind was like, "Okay, who do I know that I can tell, ' Yes, I think you'd make an excellent lawyer.'" Oh man. [00:32:03] Essa Abdool-Karim: You're always giving, Lindsey. It's really good. I like the way you.... [00:32:05] Lindsey Dinneen: Yeah. So giving. [00:32:07] Essa Abdool-Karim: Helping propel everyone forward. It's really good. [00:32:11] Lindsey Dinneen: Yeah, exactly. Exactly. Oh my word. Oh my goodness. Okay. Yeah. So how do you wish to be remembered after you leave this world? [00:32:21] Essa Abdool-Karim: Yeah, it's a good question. You know, I deal with some incredible entrepreneurs that at this point in their careers, they're not even thinking about, you know, exits or companies. They're thinking about legacy and they want to be sort of remembered as luminaries and experts, not just experts in the field, but people who sort of change the world. So for myself, I do eventually want to get to the point where I can change the world. I don't know what that's gonna look like or how it's gonna happen, but I want some sort of positive lasting influence in the world that I played a part doing. Now interestingly mentioned like how do I want to be remembered? I don't necessarily have to be remembered for doing it. But I want to know to myself that I was a part of it. [00:33:02] Lindsey Dinneen: Yeah. Absolutely. Yeah. And then final question, what is something that makes you smile every time you see or think about it? [00:33:15] Essa Abdool-Karim: My life. Just... [00:33:19] Lindsey Dinneen: Yes! [00:33:20] Essa Abdool-Karim: You know, retrospect really is 2020. And it's this crazy, life is just crazy thing, right? You know, we go through so many difficulties and everybody does. You just can't see it, right? We all go through these difficulties, these ups and downs, these mountains and valleys, these peaks and valleys, and no, not everybody sort of broadcast what they go through, right? A lot of times you only share the good things particularly with social media today, and that can have a negative effect on a lot of people's mental health. [00:33:49] But I look back on my life, and I think, if that hadn't happened, I wouldn't have ended up there. And I really was happy doing that over there. But, and if that didn't happen, if that did happen, I wouldn't have ended up there and I probably would've been miserable over there in that sort of situation. And I realized, and I look back and there's this puzzle forming, this beautiful tapestry, and I realized how beautiful it all is. [00:34:09] And I smile because I like to sort of sit and think, like I can sit in front of an ocean or something or some sort of skyline view and just sit and just think about this sort of stuff in retrospect about all of this sort of stuff and how all these sort of things happen. And in the moment you can't see it, you're blind because we can't see forward. We can only imagine forward. Right? But, when you look back on everything, everything happens for a reason. I truly do believe that good and bad and a better day will come. [00:34:37] I smile because you can't see it then, I probably can't see it now in whatever situation I'm in now, right? But, you know, there might be a day where I'm gonna look back, laugh at it, smile at it like I often do. So yeah, my life is probably one of the things that I smile at one of the one of the most, just looking back in retrospect. [00:34:55] Lindsey Dinneen: Yeah. I love that answer and I'm so glad to hear it. I love that enthusiasm for life and that perspective of there's a reason for things, and if this didn't happen, then I wouldn't be where I am today. [00:35:06] Essa Abdool-Karim: Yeah. [00:35:06] Lindsey Dinneen: Yeah. And I think that helps. Go ahead. [00:35:09] Essa Abdool-Karim: Absolutely. No, and I think that intro spec is critically important because it, you have to try to make sense of things, right. And I, the problem is, in my view, right, we're so caught up in the grind that we don't take that moment to just go to sort of reflect. And I think if you do there, you achieve some sort of clarity. Everything seems clouded right now. And entrepreneurs will tell you this, they're doing a million things at once and I'm not even exaggerating. They probably have a hundred things on their to-do list. And you get so bogged down in it, you can't look up. [00:35:39] But one of the best solutions to that is to step back and think about how things have played out in your life thus far, and where you are today and how that happens. And even if you're not where you want to be today, tomorrow is still there. So I think taking that moment for introspection not only helps you sort of process everything that happened in the past, but you know, also helps you move forward into a better future. [00:36:01] Lindsey Dinneen: Yes. Absolutely, could not agree more, great perspective. And it keeps you sane too 'cause there's so much out of our control that if we can control our attitude and our perception and the way that we choose to process and reflect, then we can still choose to see the good even when it's, when it might be a little bit tricky 'cause it doesn't feel good in the moment. [00:36:27] Essa Abdool-Karim: Absolutely. Absolutely. And there's an interesting sort of, I don't know, I don't know if I wanna call it a theory, but scarcity mindset versus an abundance mindset. And I, for a long time was part of the scarcity mindset model. And for those who may or may not know, scarcity is where you think there's just, "oh, there's never enough business out there for me. I'm never gonna be able to make, you know, enough money. Or make the right connections or people." And when someone else does it, you're like, "oh no, how could they have done it? Now I can't get it anymore," sort of thing. But that sort of thought process is very defeatist. It's self-defeating, actually. Where, whereas if you come from the thought process of an abundance mindset where like, "oh, okay, they did that's great for them. I can do it too! There's more than enough people. There's more than enough business and more than enough opportunities for me to execute on. And sort of take advantage of. And, we're all gonna make it one day." So, [00:37:18] Lindsey Dinneen: Yes. Yep. I Fully agree with that and could talk about that forever, so I'll have to restrain myself this time. I fully agree with you this has been a fantastic conversation. I so appreciate you sharing your advice, your background, some things to consider, and just your very positive outlook on life. I think that's incredible. So we are really honored to be making a donation on your behalf as a thank you for your time today... [00:37:48] Essa Abdool-Karim: No, thank you. [00:37:50] Lindsey Dinneen: ... to Sleep in Heavenly Peace, which provides beds for children who don't have any in the United States. So thank you very much for supporting that particular organization, and I just wish you the best continued success with your abundance mindset and your and your zest for life as you work to change lives for a better world. [00:38:10] Essa Abdool-Karim: Thank you. Thank you so much. Thank you for having me, and you're a wonderful host and I love what you're doing with the podcast. And I hope for your success in the future, for continued success. [00:38:20] Lindsey Dinneen: Well, thank you! very much appreciate that. And thanks also to our listeners for tuning in, and if you're feeling as inspired as I am right now, I'd love if you share this episode with a colleague or two and we'll catch you next time. [00:38:33] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Meet Alexander Ballatori and Shane Shahrestani, two innovative minds revolutionizing the medtech industry with their groundbreaking company, StrokeDX. Their story is not just about technological innovation; it's a tale of resilience, determination, and a deep-rooted desire to enhance stroke care. Amidst financial hurdles and skepticism, their commitment to transforming stroke diagnosis and treatment shines through. Their episode is a must-listen for anyone intrigued by the confluence of medical technology, entrepreneurial spirit, and the profound impact of personal experiences in shaping healthcare solutions.   Guest links: https://www.linkedin.com/in/shane-shahrestani/ | https://www.linkedin.com/in/alex-ballatori/ Charity supported: Sleep in Heavenly Peace Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 027 - Alexander Ballatori & Shane Shahrestani [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. [00:00:50] Hello, and welcome back to The Leading Difference podcast. I'm your host Lindsey, and I am so excited to introduce you to my guests today, Alex Ballatori and Shane Sharasani. They are the creators and innovators extraordinaire behind StrokeDX, and I'm so excited just to talk with them, find out more about the innovation and see where they're going from here. So thank you all so much for being here. [00:01:11] Alexander Ballatori: Yeah. Thank you so much for having us. We're really excited to be here. [00:01:15] Lindsey Dinneen: Excellent. Excellent. I'd love if you two wouldn't mind starting off by just sharing a little bit about yourself, your background and, well, let's stop there. Let's do that first. [00:01:26] Alexander Ballatori: Great. I'll go ahead. So, I'm Alex. I'm originally from upstate New York, from Rochester, so very grateful to be in sunny California at the moment. Now that we're entering the winter period. But I went to the University of Rochester to study biology and chemistry. I was really interested in medtech and medicine in general. And I want to take some time before deciding what type of graduate degree I was going to pursue as well as learn a bit more about the startup ecosystem. So I ended up living in San Francisco for a few years. I really got to see a lot with respect to medtech in general, predominantly in the orthopedic in the pediatric health space, and then I ended up choosing to go to medical school where I met Shane is my first roommate in medical school and we hit it off right away started. [00:02:07] This is our 2nd business together and yeah very passionate about stroke. Stroke has impacted my family numerous times and when I saw this creative solution that Shane developed during his PhD and also just given my long lasting interest in medtech, it was a no brainer to start this company with him, but I'll let him kind of take over from there, give him some background, and then we can dive into more about our story as a company. [00:02:32] Shane Shahrestani: Thanks, Alex. Yeah, so my name is Shane Sharasani. I grew up in sunny Southern California, very different from Rochester. And I was at UCLA for undergrad. I studied neuroscience and then I did my MD PhD, my MD at USC and my PhD at Caltech. And the way they designed that is you do 2 years of med school, you do the full PhD and you come back and you finish med school. So in the first 2 years, I saw the effect that stroke had on patients. And when I went into my PhD, I wanted to develop technology that can solve that problem. Namely, having timely access to stroke care diagnosis that you receive faster treatment because time is brain. So that's where this idea came about. [00:03:13] We pivoted this tech from the aerospace industry and developed this tech for stroke detection. And when it came time to spinning out of Caltech, there was no other partner that I wanted on this other than Alex. He's my best friend and also my first roommate, as he said. So it made sense to work together and we work very well together. So since then, it's been a exciting journey since the end of 2020 when we spun out and filled with highs and lows. And we're happy to be here today on this podcast. Thank you. [00:03:46] Lindsey Dinneen: Yes, of course. Again, thank you all so much for being here. And it's just fun to hear how you guys got connected in the first place, and the fact that, you know, this roommate, which could be so hit or miss, let's be honest. And it just turned into this fantastic friendship and now business partnership. So I love hearing those kinds of background stories. So, you know, Alex, you mentioned having a personal connection to stroke, and perhaps Shane, you do as well, but I would love if you would share a little bit about your, your own experience and kind of what really motivated you all to tackle this issue and to try to make a difference in this arena. [00:04:26] Alexander Ballatori: Yeah, so, I mean, it started really close to home with my grandfather, actually, as well as a couple other uncles and great uncles, unfortunately. And, you know, my, so both my family, both my parents are clinicians by training. And so, when I saw them, and I saw the care that they received, my, my family was always, my, both my parents were very strong advocates for anyone in my family that became ill. And when I saw my family members go through stroke care, I saw that even if you have the best advocate at one of the best hospitals, there's still so many inefficiencies in the care that we can deliver. [00:05:00] And then going to medical school and seeing it firsthand when we are now. I was functioning as the provider at that point, there's just so, it's just so many issues. And despite all the advancements we've made from surgical technique and therapeutics, we haven't put a dent in stroke outcomes in multiple decades. So, you know, when we, when I first saw what this technology could do, the chain had developed at the price point that it can, also at the safety level and in the amount of time that it can deliver this information, I saw all of those problems from at my, within my family and within my medical training. That could be solved just with this simple, elegant, low cost solution. [00:05:42] Lindsey Dinneen: Yeah, that's incredible. And Shane, do you have anything to add to your own experience with stroke and what motivated you to develop this? [00:05:51] Shane Shahrestani: Yeah, of course. So I briefly touched upon the fact that I went to the PhD, I already had some experience with stroke in terms of dealing with patients in medical school and really looking at the inefficiencies there. Why are we ordering so many CTs? There has to be a better way to monitor at the bedside. And why do we not have that? Right? And now I work as a neurosurgery resident and those problems still exist. So many patients every day have to be sent back to the scanner just because something changed about their exam, and we have no idea what happened until we send them down to this big, bulky, expensive machine that requires transport. It uses radiation and there have to be better ways to solve these problems and provide the information at a point of care at a efficient cost to the patient in the hospital system. [00:06:41] Lindsey Dinneen: Yeah. And so I would love if you both or one would share a little bit about the technology itself, kind of where you are in process with approvals and all that fun regulatory excitement and just, you know, what do you envision for your company as it grows? [00:07:01] Shane Shahrestani: So from a tech perspective, there are sensors that they use in aerospace to look for cracks in airplane wings. And we have methods for non destructive detection. That's what they call it: "non destructive testing and detection" that we use every day in other fields. So what we did is, we took this technology and we optimized it for the human body, specifically for the brain and by doing so you can create a non invasive handheld, small, cheap, portable, non radiating technology that you can use anywhere to quickly assess objectively how the brain is doing in terms of its cerebrovascular health, right? [00:07:52] And the idea is it works a lot like a metal detector, right? And in stroke, you can either have too much blood in the hemorrhage or too little. And in ischemic stroke, where you're literally stopping blood flow. And if you have a metal detector that's tuned for the human body and for blood, then you can quickly assess how is the blood flow changing and what are we going to do about it? So that's the technology, and I'll pass it over to Alex to talk about the rest. [00:08:17] Alexander Ballatori: Yeah, so absolutely. So given that this technology can differentiate, localize, as well as produce an image of where the lesion is, and in stroke, again, there's two types of stroke. You need to know what type of stroke they're having. And then once they have the stroke can progress over time. So back in 2020 and 2021, when Shane was first validating this technology with an NIH funded grant awarded to Caltech and USC, we saw that it could provide all of that critical information in a very compact form and in a very low cost form. [00:08:48] So once we published that information in Nature Scientific Reports, we went out and started the company. We went out and started to raise money. And one of the, one of the things that we knew is that our basis, the basic form of our technology the common baseline principle, how it works could impact the entire stroke continuum. Right? So the stroke space has a lot of problems. So, for example, 1 out of 6 stroke patients in an ambulance goes to the wrong hospital because we can't evaluate their brain. Often stroke patients are just found down. Right? [00:09:20] So as an EMS personnel, all you want to do is get them to the closest hospital. But unfortunately, not all hospitals can manage stroke patients. So, one out of six times they're wrong, and that leads to hours in their delays in care. And like Shane said, time is brain. Every minute that passes, you lose a million neurons irreversibly. So, that's the first problem. It's kind of like the EMS. [00:09:38] Then in the emergency department, it still takes quite a while to rule in stroke, because we rely on CT scans. And there's also just a whole slew of things that have to happen for a patient in that process of getting admitted to the hospital. So stroke on average takes over two hours to diagnose from the initial symptom onset. So that's kind of the pre hospital, early hospital problem within stroke care. [00:10:01] The other big problem in stroke care is we don't have any way of monitoring patients at the bedside with a disease that's rapidly progressing. And so currently we just send patients back down to CT, on average four times for admission. And so 80%, unfortunately, these repeat scans are negative. Nothing had changed in the brain, but we require objective information to manage these patients appropriately. So we keep sending them back. [00:10:26] The other problem not to get too into the weeds with this is that most stroke patients are above the age of 65. They are enrolled in Medicare and the Medicare bundled payment system. Ever since it came out, hospitals have been losing money across the board route on stroke care, and a big contributing factors are inability to monitor and image the brain in a timely manner. So that problem also goes into the neuro rehab setting where hospitals are now pressured to push patients into neurorehab where they're getting paid, you know, per diem. And also can kind of close the DRG. [00:10:56] So you can kind of look at the stroke continuum as two problems. The early hospital, pre hospital, and then the inpatient inability to monitor this rapidly progressing disease. We have built an automated device for that second space, the inpatient and neurorehab space. Which is an automated, lightweight device that takes our sensor and has two mechanical arms that move it around the patient's head in a completely automated fashion, removing the human element to the path and the scanning path. [00:11:23] And so what that enables us to do is it enables us to put this device-- it sits right at the head of the bed-- all you have to do as a user is set them up in it, which takes less than a minute. You press go on a tablet and it scans everything and tells you all the information that's happening right at the point of care. It also enables us to leave it on and monitor patients over time, which is going to be a game changer in inpatient stroke care, where currently it takes quite a while to get patients to CT. [00:11:48] And again, 80 percent of the time it was a negative scan. So it's a completely inefficient process. That's actually we estimate to be over a 6 billion in efficiency in the U. S. alone. So we're first pursuing that, but not to say that we're not interested in the pre hospital space. We still are very interested in prehospital stroke ruling and so a lot of our diluted first round of our first round of funding, which was just about a year ago, we came to our 1 year mark, like 4 or 5 days ago, is spending a lot of time on improving our sensors capabilities, which we've improved about 3 X from what it was back in 2021. [00:12:21] So ultimately we are pursuing the inpatient space first, because there's a very clear problem for us to solve that we can solve, but it's not to say that we're not going to go for the outpatient space at a later date. We are still very actively pursuing it because our technology will be the one to solve that problem as well. [00:12:39] Lindsey Dinneen: I love it. And I love how bold and confident y'all are in your ability to do this because it's exciting to see that there are such amazing innovations and there's progress in this space. So thank you for doing the work to make that happen. I know that's going to impact so many people's lives. And also, I want to say congratulations because y'all are winning so many awards. I was looking at your LinkedIn pages and it was so fun to see, you know, post after post. So tell me a little bit about some of your recent wins, if you'd love to share that. You've been part of the MedTech Innovator Accelerator cohort for a year ish now. So yeah, just tell me about your experience and what you're celebrating. [00:13:25] Alexander Ballatori: Yeah. I mean, it's been an incredible process. MedTech Innovator is by far the most significant thing we have participated in since forming our company. The doors that were completely shut and locked and sealed that we could never potentially even knock on are now wide open because of MedTech Innovator. So yes, we've been participating for the past year and it's been a wonderful experience. First, starting off at the the pitch events at UCLA, where we pitched to the judges, where they narrowed it down. They had about 1200 early stage companies. I think a total of 1900 applications in total. And they, after those pitch events, which there were five, they narrowed it down to 61 companies total and about, I think it was 40 early stage companies. [00:14:06] So we enrolled in that program and got assigned to some incredible mentors, got to meet all of these amazing alumni that were either first time founders or seasoned, seasoned founders that have been through a lot. And we just had this complete access to this amazing network of people that we could talk to. And so, you know, it started off with Wilson Sonsini, the Innovator Summit, and the Wilson Sonsini medical device conference where we were picked to be in the top five for the vision award, which is based on the criteria, "would you invest in this company? And would you want to work for them? And do you find them inspirational?" [00:14:38] So we made it into the top five, which we're pretty surprised about, honestly, because it was a cohort wide boat. And then we had 7 minutes to pitch very similar to the finals, which I'll get to in a second. And we won that, and that was the first kind of wave of, you know, just increased interest in us, a lot more visibility for us, and a lot of validation. Our 2022 was a very very trying time for us, which we can talk about later. But anyways, that was the first big win for us. [00:15:05] And then we participated in the cohort and got to know the MTI team and our mentors and go through the value proposition program. It was so helpful for us in so many ways, and it culminated in us making it to the finals at the AdvaMed medtech conference, whereas a similar setup, we had about 7 minutes to pitch, try to explain all of the wonderful things about our technology in just a couple of minutes. After a crowd vote, we ended up winning. And so, it was really special for us because in 2022, as young innovators, you get a lot of doubt, you get a lot of no's, you get a lot of people saying you're crazy. And so to win that was really special. And I want to give Shane a moment to say anything else with respect to that too, but it was just a really sweet moment for us after what we've been through. [00:15:48] Shane Shahrestani: Yeah, a hundred percent. You know, we were two young guys in medical school, no previous business experience, trying to spin out a medtech company while also being in medical school. And the number of times we got said no to, we completely lost track. So to be able to build back up and to make it to a point where we're actually the top startup in medtech in the world was, you know, we didn't even believe it. And also, you know, a couple other things it was, Alex and I just went so much. It was awesome working together as a team over the last year and figuring out all these other problems that came up. And at the same time, at MedTech Innovator, we met so many other people going through similar problems as us. And there are so many amazing cohort companies that we got to meet who are going to change how medicine is provided in the U. S. and globally. So it was an absolute pleasure to work with all of them and to work together to solve so many problems in MedTech Innovator. It's cool. [00:16:47] Lindsey Dinneen: Yeah, that's incredible. I'm so glad that you guys had such a great experience with the cohort. And again, yeah, congratulations for winning the whole thing. That's fabulous. And I think it does speak to the innovation that y'all are bringing to the world and how important it is. And obviously you're getting some really good external validation. I mean you know the value that you're bringing, but it's always nice to have an outside person saying, "yes, we agree," you know, and to that point, I'm really curious about your 2022, because you kind of mentioned that that was a little bit more trying. So if you'd be willing to speak to that, I'd love to hear a little bit about that. [00:17:28] Alexander Ballatori: Yeah, absolutely. So like Shane mentioned, we were both full time in medical school. We were in the hospital for, I don't even want to admit how many hours. I don't think I'm allowed to say how many hours. And you know, trying to form a pitch deck. And, we're both heavy in science and research and we know how to build the presentation typically for the scientific community, right? And so, and again, we're clinicians, like, one of the reasons why I mentioned before, I think, before the recording, one of the reasons why we're so excited to come to this podcast is that this podcast is really about increasing and bringing technology to increase human health and improve human health. [00:18:05] And, you know, one of the things that we were passionate about, and still are very passionate about, is that we want to bring this product to market because we know it's going to help a lot of people. But one of the things that we had to learn is that we needed to pitch a company, right? We needed to pitch a vision and a mission, which we had the vision and the mission. It's gotten much more refined. But we had, that was our, I think our first learning curve, which we give a lot of, we have got to give a shout out to Helen McBride and Julie Schoenfeld from Caltech, as well as our lead investors at Freeflow for helping us with that one. [00:18:33] But it was tough. We were pitching during our lunch breaks and we were pitching on the weekends and we had investors lined up and then unfortunately, the day before the round of funding was supposed to come through, the markets went south and they said, "Hey, we're not investing right now. So sorry." And we were in a good amount of debt. And so, it speaks to one of the value or one of the most important things when starting a company is kind of faith in your mission and faith in your founder. [00:18:57] We were sitting and just looking at each other like, "man, what are we gonna do right now?" Like, we were still fully deep in school studying for our board exams, and we were in debt and we couldn't even build anything. And so, you know, we kept going at it and we really believed in what we could do. And we ended up finding Freeflow Ventures with David Fleck and Kevin Barrett who believed in us and, and saw our vision as well as the individuals at Caltech, and then we ended up finding quite a few other angel investors who are all directors of stroke centers, neuroradiologists, triple board certified neurologists, and you know, experts in clinical trial neuro design. [00:19:34] And they all believed in us. And so we got the money that we needed. And we've been sprinting ever since, which is why we've been able to accomplish so much in the last year. And, you know, now looking back, Shane and I were just talking about this, after we'd won MedTech Innovator finals and we were like, you know, 2022 was really tough, but it put us in a really good position because it forced us to study everything about the market, learn everything about our competitors. And really hone in on where are we going to bring this thing first? Right? Because like I said before, there's an entire continuum of stroke care where the sensor could be applied and we will apply it to all of those areas. [00:20:12] But what did we want to do first? Right? And so I think us having to go through that tough time is one of the reasons why we're so successful in such a short amount of time. So it was a tough time, but we're obviously, I think we're doing much, much better out of it. Now we can, you know, when you look back at it, we're grateful more than anything else. It's taught us a lot and definitely earned our stripes. [00:20:35] Lindsey Dinneen: It sounds like it. Shane, do you have anything to add to that? [00:20:39] Shane Shahrestani: Pressure makes diamonds. I mean, we felt the pressure. We definitely felt the pressure. It's an understatement, but you know, we learned a lot and we were able to thoughtfully revise our pitch decks, our business plans, our engineering plans with all the no's that we were getting and the feedback that we were getting underlying those no's and that's how we were just able to learn and grow. And I think there's something to be said about being young and trying to run a business. I think a lot of people don't necessarily believe in you, especially when you're asking for millions of dollars. So, we learned that we, as Alex said, earned our stripes and proved ourselves and that we were serious and we knew what we were doing. [00:21:27] Lindsey Dinneen: Yeah. And you know, what's so interesting is, when I was looking at both of your LinkedIn profiles and just seeing, I kept thinking, do you guys sleep? Do you have time to sleep? [00:21:40] Alexander Ballatori: We're sponsored by caffeine. That's actually, so Shane and I, before we even started this. We, I don't know, Shane, how many papers we published together and like 30 at least and so many conferences. And it was honestly like that, that the number of nights where we consumed hundreds of milligrams of caffeine, just working together is how we knew we were going to be great business partners. And so, you know, again, we're StrokeDX is sponsored by caffeine. [00:22:06] Lindsey Dinneen: Amazing. Can we get that official so that you actually don't have to pay for your coffee or whatever? Your caffeine of choices. Incredible. So this journey from, and obviously you probably wouldn't consider it a complete pivot or anything, but this journey from clinician to entrepreneur, and everything that entails, you know, obviously, like you said, 2022 was this huge learning curve. What would be some advice that you might have now looking back and being able to say to somebody who might be in a similar situation, maybe what's a one or two pieces of advice that you would say would be beneficial? [00:22:49] Shane Shahrestani: All right. A couple of things. One, find a co founder that you trust with your life, who is your best friend, that you'd rather be awake drinking Monsters at 3am than being asleep. That's very important. Two, every time someone says, no, that's an opportunity to learn and grow. And if you have the resilience and grit to keep your head up when you're being told no and to learn from it and to keep going forward, it will always work out. [00:23:20] Alexander Ballatori: Yeah, that's exactly, literally exactly what I was going to say. You know, someone gave us a good piece of advice. They said, expect to receive 200 no's. And so when you get your 113th, you know, you're barely, you've just barely crossed the halfway mark. Just keep going, because you should expect 200, right? And that was something that, you have to be a little crazy to do this. But also, I think, in addition, like what Shane was saying, you need to have someone that when you hit a low, you know that you can trust the person next to you and you just say, "okay, let's learn from this. Let's refine our approach. Let's , amend our deck and our plan. And let's keep going." Right? [00:23:58] And also, I think really taking the time to understand the market is really-- what you have, first of all, this is before you even get to this point-- you need to understand what you have, how it will be applied. And I think that was actually one of the one of our biggest benefits is that we work in medicine and we understand clinical utility, clinical need and as well as what we've learned that was very easy for us to learn because of we are clinicians is the whole pay/ payer system, right? [00:24:25] And, you know, price points and pricing strategies, it's all kind of coming from a clinical side. And seeing these products that I know how people use them. I've seen them use. I've used them. It just made it a lot easier for us. But yeah, ultimately boils down to having a strong partner. And and not taking things too to heart when people tell you that you're crazy. [00:24:51] Lindsey Dinneen: Yes, indeed. You know, that reminds me, I remember one time somebody saying, " when you hear no it's very rarely no forever. Never going to consider it, the end, close the door, slam it, and lock it." It's usually, "no, not right now." So if you can take that with a grain of salt, if you can take those no's with a grain of salt, eventually, you'll get to either them changing their mind or somebody else saying, no, I agree with you, you're absolutely right. [00:25:22] Alexander Ballatori: Yeah, we got a lot of "not nows." And I think it really boiled down to the fact that our first prototype was handheld. And so we were confident in our decision to go into the inpatient setting. And so now the pendulum has swung the other way. And now that we've validated that our automated device has worked in this translation, translational project of automating this technology has been successful, all of those people that were the not nows are the, "are you raising money now?" questions, which is obviously a great feeling. But yeah, no, definitely. We learned a lot. There were-- also be frank. There are many times where they ask us questions that we studied for weeks afterwards and learned so much from so all those not now is really they shaped us in such a positive way. [00:26:07] Lindsey Dinneen: Yeah, yes, I can imagine. Anything to add to that, Shane? [00:26:13] Shane Shahrestani: No, I totally agree. As Alex was saying, a lot of the previous no's are now reaching out to us. So table turn for sure, but it just takes hard work, great resilience. Got to keep your head up, keep fighting and it works out. [00:26:30] Lindsey Dinneen: Yeah. Yeah. Excellent. Out of curiosity, going back to your childhoods, could you have possibly imagined where you are now, back in the day? I mean, did you always have an interest in medicine? Is this something that sort of developed over time? Did you think you were going to be a business owner? [00:26:50] Shane Shahrestani: So ever since I was in fifth grade, I always loved the brain. I knew I wanted to do something related to the brain and now I am working in neurosurgery, but my deep passion is medtech. That's what I wake up for every day. I look forward to working with Alex and our team and solving complex problems and creating new devices that can save brain. Right? So I knew I'd be somewhere in this field, but I had no idea that I'd be able to work on a product so amazing that can really just change the paradigm and stroke care, which affects so many people every year. So, so, I never thought I'd be a business owner. I knew I'd be in the brain somewhere, but this is super exciting. [00:27:35] Alexander Ballatori: Yeah, and for me, I, so I grew up with two rockstar parents. Both came from nothing from, you know, farms in Italy, but both were very naturally gifted when it came to science and medicine. And so my parents actually met while my dad was completing his PhD at the University of Rochester. My mom was finishing up her MD. And they both saw that they had Italian last names, and then the rest is history. And then I grew up in Rochester, New York, and clouds and snow for the first 22 years of my life. But, I was very, whether it's nature or nurture, I was always very drawn to science and medicine, and both my parents actually were both entrepreneurs as well in the medical space. [00:28:13] So my dad was a pioneer in lipid and bile metabolism in the liver and developed a lot of enzymatic targets and a lot did a lot of the early work in understanding bio reabsorption. And my mom is a surgeon with multiple devices under her belt and actually is pursuing, it just gotten one of her products just got FDA cleared at the moment. They're launching right now. So I grew up in a very unique household where this is kind of dinner conversation, but I didn't know what I wanted to do. I knew I wanted to be in medtech. I knew I wanted to some sort of degree in medicine. [00:28:44] And so I took time off after I graduated and I got a degree in biology and chemistry. And so I kind of went into my time off just trying to explore as much as possible. I got my hands on so many different startups. I also got to learn from kind of the bigger medtech corporate world is getting more in respect to the orthopedic world. And so I knew it was for me, but then I was deciding PhD or MD. And for me, I liked kind of the wide breadth of knowledge that you get from the MD because there's so many problems in medicine that need to be solved. [00:29:16] And one of the things that really sticks with me is that this whole definition of "gold standard" or "standard of care," or "this is the best that we got" that I just don't, I don't like accept fully, maybe that's just kind of how I was raised or what, but I knew that I was going to, I wanted to go to medical school because I knew that there were so, there's so much more I could learn with respect to how we take care of patients that is so behind with respect to where it should be and can be, especially when you look at what's happening at some of these top universities, like a Caltech and USC and at the lab or at the benchtop. [00:29:52] So, of course, the PhD would have kind of pigeonholed me into one very specific area that I couldn't decide what I was super interested in. So to tell to go back to your question, if I, if you ask me 5 years ago, if I would be doing exactly what I'm doing right now. No, there's no way. But given my background, given my experience with stroke and then, you know, working with Shane, it just really harmoniously kind of just worked out very well. [00:30:17] And I'm really looking forward to the next few years and seeing where we can take this and then the next one as well. And the next one after that. Shane and I have a very common, one of, one of the we're I keep saying we're crazy. We kind of are in many ways where when a finish something a little bit, when we finish a task and we like finish our to-do list, the next thing we say is not like, "let's go grab lunch or grab dinner or something." It's "alright, what's next? What do we do next?" Right? And so I know the day... [00:30:40] Shane Shahrestani: I'll call Alex at like 6, 7 p. m. and be like, "Alex, I'm itching to do something. Like, just tell me something to do. What needs to be done?" He's like, "dude, you just worked a 14, 16 hour day. Why do you want more work?" I don't know. I just, it feels wrong. [00:30:56] Alexander Ballatori: I was like, Shane, go to sleep. [00:30:57] Lindsey Dinneen: It's all that caffeine. You've got your system wired, ready to go. Oh my word. Oh, that's incredible. Oh, my goodness. So out of curiosity, are there any moments or maybe one moment or whatnot that kind of stand out to you? It could be through medical school, it doesn't necessarily have to be with StrokeDX, but just a moment that stands out to you as saying, "yes, I know exactly why I'm here. This is it." It's reinforced for you: "I am in the right place at the right time doing the work that I really feel passionate about." [00:31:37] Alexander Ballatori: Yeah, you know, I think there wasn't one specific moment, but more so a process over 2022. And being told no, so so many times. And then finally battling through debt, and thank you so much to our lawyers for being very flexible with us on that. But when we finally got the amount of investors that we needed and the amount of money that we needed, everything, just we were on fire. We were so ready and we had such a strong plan. The moment the money came in, it was we were already starting to send it out the door to our engineers to start paying. And we started working that the same day that the money came in, we had a meeting with our engineers to start working. And I think just that transition point from going from trying to sell the mission to actually executing it was definitely a highlight for us. So I don't think there's one specific moment. But I think it was that kind of transition and seeing all of our incremental improvements in our sensor and seeing this device come to life. It's just been, it's, I think it's almost the whole process is really just validated that this is where I'm supposed to be. [00:32:45] Shane Shahrestani: Yeah, I think to the families of people who had a stroke and explaining to them what a stroke is and the prognosis and what's going to happen to their loved one, and then seeing people unfortunately pass because of stroke, and maybe they live too far from a hospital and their life could have been saved if they came in a little bit sooner, or they didn't know that they were having a stroke and they tried to sleep it off and woke up and couldn't move half their body. Right? And the stories go on and on. You see it in every permutation and every variation. But then, at the end of the day, these are people and their loved ones are in the hospital with them and you're trying to keep them alive and all our odds are against you and it's a function of losing brain cells and that is a function of time and efficiency, right? [00:33:41] So a big why is just so much suffering, sadness, loss can be prevented by creating new technologies that can just make healthcare more efficient for people, right? Faster, cheaper, better diagnostics, better assessment tools, better ways to monitor. And you know, that's another reason why I think Alex and I, you know, share that in common and we just work tirelessly just to create new things to just change the paradigm, change the standard of care, make things better for people. 'Cause that's just where our heart and our passion lies. [00:34:20] Lindsey Dinneen: Yeah. Yeah, absolutely. I'm very glad that you both did not let all the no's deter you. I'm glad you were willing to come back to your why and just keep at it. Yeah, that's, that takes a lot of grit and determination, but glad y'all are doing what you're doing. So, pivoting just for fun, imagine that you were asked to teach a masterclass on anything that you want. You're going to be given a million dollars for this. What would you choose to teach and why? It also doesn't have to be related to your industry at all, although it could be. [00:34:58] Alexander Ballatori: I, so my family and my my, just family events and cooking is, and my Italian heritage, is very important to me. And so I, it's, when I'm not working, I'm cooking or I'm spending, I make wine for fun. It's just it's all the traditions from my family. So I think if I had to teach a class, it would probably be sharing some of my family recipes, and also I love to cook and host all the time. So I like have had cooking classes at my house with friends and every year I make wine. It's always a big event and always have people over it. It's a really simple process. It seems so daunting, but it's quite simple, especially when you do it the old world way. And so, yeah, I guess I guess that would probably be mine. [00:35:45] Shane Shahrestani: First of all, I would go to Alex's masterclass. I'd pay however much he charged. I'd be there. His wine is like the only wine I drink now. If I had to teach a masterclass, so there's two things about me that I don't even know if Alex knows. I can identify the Latin name for any insect, any insect. And also I can classify like any saltwater fish, like tropical fish. So, somewhere between insects and tropical fish, just like, you pointed out, I'll just tell you what it is. [00:36:17] Alexander Ballatori: No way. Get out of here. We gotta go to the Galapagos. We're going on a trip. [00:36:23] Shane Shahrestani: Dude, I'm ready. We'll be the new Charles Darwins. [00:36:28] Lindsey Dinneen: Okay, so if I were to just take a random photo of a bug, I could just send it to you and you'd go, yeah, that's a... [00:36:34] Shane Shahrestani: A hundred percent. I can tell you like what order and like species that bug is. [00:36:41] Lindsey Dinneen: Amazing. [00:36:41] Shane Shahrestani: Yeah. [00:36:42] Alexander Ballatori: Incredible. [00:36:45] Lindsey Dinneen: We learn something new every day. I love it. [00:36:48] Shane Shahrestani: Just when you thought I couldn't be more nerdy, Alex. [00:36:52] Alexander Ballatori: No, so the reason why I'm laughing is because I used to do the exact same with any, you could show me any dinosaur skeleton and I knew I could do the exact same thing. I definitely can't anymore. I definitely cannot anymore. [00:37:05] Shane Shahrestani: That's so funny. [00:37:06] Alexander Ballatori: That's definitely just harsh parenting on like repeated flashcards. It was some genuine interest there, but [00:37:15] Shane Shahrestani: That's incredible. [00:37:17] Lindsey Dinneen: Amazing. I see how, you know, your, some of your childhood interests or pastimes have led you to successful careers in medicine, 'cause that amount of memorization must be daunting, but it clearly isn't because y'all have been doing it your whole life. [00:37:32] Shane Shahrestani: It's been the journey, from insects to here, you know. [00:37:38] Lindsey Dinneen: Amazing. Alright, on a slightly more serious note, how would you like to be remembered after you leave this world? [00:37:46] Alexander Ballatori: That's a great question. You know, I had a mentor at UCSF that was in a very similar position to where I kind of see myself in the later years of my career and it's very difficult to be a clinician full time and still spin technologies out, run the kind of the business end of things. And, he was someone that did it. He was someone that did both, and that's something that I also aspire at some point. And, we had this conversation where you kind of have to view it as, "do you want to be the person that takes care of the tree? And you can see the impact from your own hands on that one person? Or would you rather maintain the forest and drive things that can impact the entire forest?" It's something that sticks with me always. [00:38:35] And like I was mentioning before, just this whole concept of standard of care or gold standard, the best way to do something that I never really fully accept. So I think it's kind of not fully concrete, but I think continuing to spin out technology that these amazing technologies that are stuck at the benchtop. And through this kind of bureaucratic tech transfer process, I really see myself down the line. I would like to be remembered by our ability to take these amazing technologies and not accept that things are just the way that they are because they never are, right? We used to operate without gloves and not that long ago and wondered why our infection rates were so high. So I think for me, just down the line, I'd love to be able to be remembered by bringing new technologies and not accepting that what we currently considered the best way to do it, the actual best way to do it. [00:39:23] Shane Shahrestani: Yeah, I think, similarly, I think we all have family and friends that we love and we cherish. And I think everyone's biggest fear is losing someone that they care about. And I think we have one shot in life and my personal mission statement is just to do whatever I can just to spread positivity, happiness, ways to, to maximize that love and keep people around. Right? And I really think that medical devices and medicine and new technologies are the way to just create new solutions to problems that affect everyone. Or will affect everyone at some point in their lives. So, it would be great to be remembered as innovators, someone who can create that device that saved my brother or my mom, you know? And I think that's also a big dream or aspiration that, that we work towards every day. [00:40:26] Lindsey Dinneen: Yeah, absolutely. Yeah, and final question: what is one thing that makes you smile every time you see or think about it? [00:40:36] Alexander Ballatori: I mean, I love seeing a big table filled with food anytime, because it's, again, it's my family. We used to get together every Friday, every Sunday, no exceptions. Everyone is there, 50 to 100 people. And so every time we open a table and it's like I'm going back to upstate New York for Thanksgiving and for Christmas. And so every time I see there, I think about it, you know, we've all grown now and we're all kind of all over the place. So we don't get together as much. So anytime I think about that's definitely that's definitely my, my, what makes me smile for sure. [00:41:06] Shane Shahrestani: Lately I've been smiling, looking at that big check we won at MedTech Innovator. [00:41:16] Alexander Ballatori: Me too. Me too. Me too. [00:41:17] Shane Shahrestani: Yeah. So we'll leave it there. [00:41:20] Alexander Ballatori: And our new device rendering also makes me smile. [00:41:22] Shane Shahrestani: That's oh yeah. Yeah. That makes me smile. [00:41:25] Alexander Ballatori: It's also both of our phones screensavers. So we're smiling a lot. [00:41:31] Lindsey Dinneen: I love it. That's fantastic. It's just motivation day in and day out. You just look at it and go, "yeah, this is great. This is what we're doing." Oh my word. That is absolutely incredible. And this has just been so much fun. I really appreciate you both joining me today and sharing more about your backgrounds and your passion and all of the really exciting innovation coming out of your company. Again, thank you. Thank you for what you're doing for the world. It matters. And it's really cool to see you take the challenge and get past the no's to get to those yeses. So thanks. [00:42:08] Alexander Ballatori: Yeah, no, thank you so much for allowing us to share our story and make sure you follow us as we are moving very quickly and starting to collect clinical data. And so it's a very exciting time to, to start following us. If you aren't already, it's now is the best time to start. [00:42:22] Lindsey Dinneen: Yeah. Yeah. Yes. [00:42:23] Shane Shahrestani: Appreciate you for having us today. It's been a pleasure chatting and hopefully we do this again soon. [00:42:29] Lindsey Dinneen: Yeah, absolutely. And we are so honored to be making a donation on your behalf as a thank you for your time today to Sleep in Heavenly Peace, which provides beds for children who don't have any in the United States. So thank you for choosing that organization to support. And yeah, we just wish you continued success as you work to change lives for a better world. [00:42:52] Alexander Ballatori: Thank you so much. Thanks again. [00:42:53] Lindsey Dinneen: Of course. And thank you also to our listeners for tuning in. Please go follow StrokeDX. Like they said, they are moving quickly and you will definitely want to be on top of that. And if you're feeling as inspired as I am, I'd love if you'd share this episode with a colleague or two, and we will catch you next time. [00:43:14] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.  

Laura Yecies, CEO of Bone Health Technologies, shares her journey from a tech and marketing background to leading a company that's revolutionizing the treatment of osteoporosis with Osteoboost, a wearable device using NASA-proven vibration technology. Laura's diverse professional experiences highlights her personal motivation to improve people's lives. Her story illustrates a passionate commitment to developing non-pharmacological treatments and fostering better patient support, emphasizing the significance of technology in advancing healthcare. Guest links: www.bonehealthtech.com Charity supported: Equal Justice Initiative Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 026 - Laura Yecies [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. [00:00:50] Hello, and welcome to The Leading Difference podcast. I'm your host Lindsey, and I'm excited to introduce you to my guests today, Laura Yecies. Laura is the CEO of Bone Health Technologies, makers of Osteoboost, which is the first clinically proven, safe and effective non-pharmacological treatment for low bone density. Osteoboost puts NASA proven vibration in a wearable, comfortable, convenient belt form factor. Laura, thank you so much for being here today. I'm so excited to chat with you. [00:01:23] Laura Yecies: Me too. Really happy to be here. [00:01:25] Lindsey Dinneen: Wonderful. I would love, if you wouldn't mind starting off by telling us a little bit about yourself and your background and maybe what led you to the medtech industry. [00:01:35] Laura Yecies: Sure. My background's in business and tech primarily. I went to college on the east coast and after business school, in 1988, I came to California. I grew up in New York, but my husband was from California and so we decided to give it a shot out here for a little bit. And I started working in tech doing marketing, first in enterprise software, relational databases, and developer tools. And then I moved into consumer softwares, started off at Netscape. And when I was at Netscape, I took on larger roles and responsibilities. I was Vice President of the browser division, managing a group of over 200 engineers, and we were responsible for Netscape 6.1 and 7.0 and the Mozilla spin out. I then led the mail team at Yahoo, when we were sort of the number one email provider. [00:02:30] And then I also worked at a tech startup and spent some time at Checkpoint, which is a large internet security company heading up marketing there as well. And then I was CEO of two different tech startups, Sugar Sink, which is a sink and share company, and that's now owned by J2 Global. And then I became CEO of a small company called Catch. We had a note taking app and we were able to sell that company to Apple and the Catch team became the core part of the Apple Watch team. So that was very exciting. [00:03:03] And after that when I was thinking about what I wanted to do next, I worked on some ideas for my own startup with some colleagues and, some things that happened in my life that really drew my attention to healthcare. And also I grew up in a family of doctors, both my parents, two of my siblings. And then at that point, my two older sons were in medicine, and I'd always been interested in that and had a bit of flexibility because of this exit and decided that, I'm gonna, I'm gonna make a pivot. And so I switched and started looking for roles in the healthcare area. [00:03:40] And everyone sort of wanted me to work in more of the pure software side of healthcare more of the billing and receiving and revenue cycle management and staffing and logistics. And that's interesting and important. But I found that I really wanted to work on something that had directly a health or therapeutic or diagnostic benefit for patients. And so I started consulting. I consulted with companies in the genomics field, MS. And then I was lucky to get my first CEO role at a concussion diagnostic company. And that company, now called NeuroSync had great science. I think they went on to get an FDA clearance for diagnosing concussions. But after a couple years, the board and I had different ideas of what to do. It sometimes happens. [00:04:26] And so I left, I spent a year consulting at Achille Interactive and at Fabric Genomics and a couple of other companies while I was looking for my next CEO role, and I was really excited to have the opportunity, just over three years ago, to join Bone Health Technologies. I knew a marketing consultant that had been there and was connected to the company, and as soon as I saw what they were trying to work on and solve and have, frankly really make a dent in this issue of osteoporosis, I was interested. [00:05:01] I mentioned that my parents were doctors. My dad had been Medical Director of a nursing home, and I worked a couple of summers during college as a nurse's assistant. And people seemed, my recollection was that they were in the nursing home typically for one of two reasons: Alzheimer's, or they broke their hip. And, my grandmother had osteoporosis. I'm a small person. It certainly runs in my family. And so I recognized that it was an important problem, a big problem, an unsolved problem. [00:05:30] And so my really, my only question for the company was, does it work? We had this innovative treatment for osteoporosis and the founders shared the data with me. It was not a sure thing, but I found the data to be very compelling and so I joined and we're three years down the line from that point in time. And one of the most important things that's happened is we finished our pivotal trial and we got the results. Now it takes a while to do a trial for osteoporosis, but we had excellent results from the treatment. [00:06:03] Lindsey Dinneen: Yeah. First of all, thank you so much for telling us a little bit about your background. You have such an incredibly diverse background. So many questions just emerge from that, but I would love to hear about your current device and the way that it works and whatnot. [00:06:18] Laura Yecies: Sure. So it's a wearable treatment. It's a belt that has a vibration pack that you wear over your lumbar spine, specifically at the sacrum. And so we're applying vibration to the hips and lower back, and those are to the key areas that experience fractures from osteoporosis. So hip fractures are very life impacting, deadly for almost 30% of people. Spine fractures, you can imagine, are very painful and debilitating. And so we're focusing vibration, which has been proven to improve bone density on the vulnerable anatomy. And, there's a body of evidence from NASA where they did whole body vibration to try to reduce bone loss for astronauts. [00:07:05] So when astronauts spend time in space, they lose bone. And what they proved was that standing on a whole body vibration platform can improve bone density. But those companies that make these platforms, they have very good products. I'm a believer in the science, but those products haven't gone mainstream. They're people that tend to not comply very well with them, and the good ones are expensive. And so we're aiming to take this proven science-- and by the way, before NASA did the whole body vibration studies, there's a lot of studies in animals and cellular research showing the same thing. There's really a lot of science to support this. [00:07:45] But our device, we aim to solve the ease of use challenge by making it something wearable. And then most importantly, the vibration is applied locally to the vulnerable anatomy. So that's what we do. And what we showed in our pivotal trial is that we reduced bone loss by over 80%. So we measured the lumbar vertebra with a CT scan at baseline in one year. And the patients who were on the active treatment lost about a half a percent of their bone strength. And those on the placebo or sham treatment lost just under 3%. Our patients, we kept them clinically, essentially stable and slow this bone loss so you don't outlive your bones. [00:08:29] Lindsey Dinneen: Wow. That's incredible. I am. . I . I say this a lot and I know it's used as sort of a more tongue in cheek manner, but for real, what a time to be alive. That is so cool how so much innovation is just constantly coming through and the, there's this, people like you are doing this incredible work to bring new devices that are really impacting patients' lives. So that sounds like incredible results. You guys must have been thrilled with those numbers [00:09:03] Laura Yecies: Yes. And this was really our first attempt. We had done a pilot study, but this was our first one year study and we just applied for a grant to do another study with in basically a longer treatment duration, essentially a higher dose of vibration. So from my point of view, this is a great result, but this is like the beginning. [00:09:26] Lindsey Dinneen: Yeah. Yes, which is so exciting too, because it just leaves room for so much more as you continue to go down this path. So that is exciting. And so that's your next step. I'm imagining, is this, next level of treatment and what do you envision the company to, to do or be doing in say, three, five years from now? [00:09:50] Laura Yecies: So in three to five years, my goal is first of all, that we have this device very widely used in the market or with patients. So there's 52 million patients with osteopenia and other 12 million with osteoporosis. Our trial was for patients with osteopenia, and so there are a lot of patients out there who I think would benefit from this device. We also want to start to develop a relationship with those patients. Not just sell them a device, but support them in their overall bone health optimization. So we today have created an OsteoBoost application. So we help patients remember and comply and we remind them and give them encouragement to use the device. We help them get the optimum amount of calcium by tracking that exercise. [00:10:41] And then, our vision is to add community and other elements of optimizing bone health and potentially to have other services. We never wanna get in the way of a patient's relationship with their doctor. So if their personal physician is supporting their treatment of their bone density issues, that's great. But in many cases they're not. And so we wanna have services available for that as well. And it's interesting if you look in the app store or look at a lot of startup activity, there's many companies doing these kinds of solutions for diabetes or cardiovascular disease or asthma or depression, but there's really not much out there for bone health. And yet it's really a key part of staying well and independent and living, living healthily, and it's such a common problem. So we're excited, that we have something unique, yet very much needed and not in a, in a small group it's not a rare thing. It's very common. [00:11:46] Lindsey Dinneen: Yes. Yes, absolutely. And is your plan to sell directly to the consumers or will you be going through, insurance companies, doctors, whatnot, or do have you gotten that far yet? [00:12:00] Laura Yecies: We haven't finalized the details of that. So we're not ready to share them. But but what I will say that I think we are quite certain about is first of all, it is a prescription device, so there will be a doctor involved to write prescription and some of the details, and we will certainly have a way where the personal physician can write that prescription. We may have some other options for patients, but a doctor's involved, which is appropriate because they have a condition that puts them at risk of fractures and other health issues. [00:12:34] But the other thing that I am confident about is that we are going to want to appeal to patients to generate interest. We have seen tremendous inbound interest into the company with not a lot of marketing. I mean, I've done things like this podcast and I speak at conferences, but we have not spent money on advertising or things like that because the product's not on the market yet. And I hear from patients all the time, they are searching for an innovative treatment. They're searching for ways safely to slow their bone loss. I, I'm a member of a number of Facebook groups for osteoporosis and hear how patients talk about this, and so I believe there's tremendous interest by patients and that we wanna tap into that to build the business. [00:13:24] Lindsey Dinneen: Yeah. Yes. And part of the reason I brought it up, the question in the first place was exactly for that reason. I was thinking there's gotta be so many people who are searching for a solution and yours is so innovative and accessible. I'm so excited to see where it leads. Yeah, that's gonna be incredible. And it really struck me, you talked about your background being heavily in marketing back in the day and so obviously those skills are still very present today. So it's fun to see how, elements of things that you've done throughout your life will lead to this success, in this next endeavor. [00:14:01] And I'm actually very curious also. yoU talked about some really amazing positions that you had, and then those led you to have these CEO roles. So I'm curious, how was that transition for you stepping into your first CEO opportunity? Was that exciting, daunting, energizing? How are you feeling in those moments? [00:14:25] Laura Yecies: Those, you captured many of the feelings. So you know, a bit of context. So it was the very end of 2008. And so the world from a financial markets point of view was kind of falling apart. I had led large groups. I had been a general manager, but I'd not been CEO. I had never raised money before, and so I stepped into a company that had been through some trauma. They were supposed to be acquired. The acquisition, the plug got pulled out because of the markets collapsing. The founder had left before I got there. So it was, the company was really in a crisis, I would say. The employees were very afraid for their jobs. We didn't have money and, the financial markets were terrible. It was really challenging to go in and stabilize things and kind of pull the team together and then, build the business in a challenging environment. [00:15:23] Existing investors gave us some runway, but it was limited. They had already kind of been in investing quite a while, and so I had to find outside money, which in 2009 was challenging. But it was exciting. I loved the product that I was working on. I had been a user of it. It was something that was in my wheelhouse of, I had worked quite a bit on productivity tools for workers and business people and consumers. And, and I, we had great technology. So it was exciting. But it was It was intense. But we built that business. When I joined we had essentially zero revenue and we got to essentially in the 20 million run rate in four years. [00:16:07] Lindsey Dinneen: Wow. [00:16:08] Laura Yecies: That was great. [00:16:09] Lindsey Dinneen: Yes. That is great. That is kudos to you and your leadership for being able to step into such a challenging situation and it around. Yeah. [00:16:19] Laura Yecies: You know, one thing I learned then, because we did have all these challenges, but we also had a market where the latent demand and need was growing. It was a rising tide. Just to be specific a bit-- and then I'm gonna give an analogy to bone health technologies. So at that time we had a sink and share solution. We were a little bit more niche, but you could think of it as it was quite similar to a Dropbox or a box.box, what was then box.net, and that was also the time that iPhone sales, laptop, Netbook sales were growing very quickly, and so the need to get your data into the cloud was I mean, you could argue that it was always useful to be able to access your data remotely. And there, there were always kind of some niche solutions like, Go To My PC. [00:17:12] But suddenly, because the environment was changing where people were having these devices the market demand and the market opportunity was growing. Okay, so fast forward, oh, 14 years, 13 years, and osteoporosis and osteopenia is growing. But the other thing that's growing is awareness. And our target demographic, postmenopausal women, I'd say our typical patients are in their sixties. I don't know, what's the joke? Sixties is the new fifties or the new forties. Like these are women who wanna stay active, right? They may be still working if they're not working. They're very involved in the community, they're very involved with their family. They may have, they may be at a point where they've educated their children, they've saved some money, so they have disposable income that they want to take care of their health. And so it's a demographic that spends money on their health. They also are very social and community minded. [00:18:16] Let's imagine a six year old woman with osteopenia and she's going on a hike or a walk with her girlfriends. What are the chances that her female friends also have osteopenia That's probably 80%, right? If similar in age, and so I see this set of patients and who we're going after as being very interested in safe non-pharmacological solutions that are easy to access. You can call it the Amazon effect. They're used to things being convenient and seamless. And they, they want this type of solution to help them stay kind of active and healthy and be in a way preventative of the need for medication. So I see this as in a very different way than Sugar Sink, still a rising tide market. [00:19:08] And oh, by the way, at the same time talking about health concerns related to menopause is suddenly, and as it should be not just socially acceptable. It's a hot topic, right? Oprah, Michelle Obama, Gwyneth Paltrow, they're all talking about menopause symptoms. And by the way, osteopenia is very much a result of menopause. You're losing bone density slowly typically starting your thirties, but in the five years after menopause, there's rapid bone loss, and that's typically when women get into that osteopenia stage. [00:19:44] Lindsey Dinneen: Yeah, absolutely. [00:19:46] Laura Yecies: Oh, by the way the women who are in their sixties today, when they were going through menopause 10 years ago, or 12 years ago, or 15 years ago, they were told no. Hormone replacement therapy unless you're completely miserable because of findings in the Women's Health Initiative. And that pendulum has now swung back to a more moderate position. But today's 60 somethings are less likely to be on HRT or to have even been on HRT, so they're more likely to have bone loss. [00:20:21] Lindsey Dinneen: . Yeah. And. Speaking of this, and you were talking about thankfully, there's much more awareness, there's much more conversation happening about women and menopause and going through symptoms and whatnot. I've just been reading lately how much it is still a struggle despite that for women founders, especially of medtech companies to get the funding that they need. And I'm curious, what was your experience when you were fundraising, what were your challenges? What were your triumphs and maybe even suggestions for other women founders who are gonna be going through this soon too? [00:21:01] Laura Yecies: There's no controlled experiments on these questions, right? So if my fundraise on a difficulty from zero to 10 was a seven. Right? Would it have been easier or harder if I were a man? I really don't know. I know that women, there's less funding going to women, but I have felt that, at least for this company, I don't have any reason to assume that to be the case. If anything. I believe that investors, many of them, they even talk about this, they're looking for founder product or founder market fit. And I'm not the founder of the company. I was brought in as CEO after it started, but I feel like a founder. I operate that way. This is my adopted child. And I love it no less than if... [00:21:56] Lindsey Dinneen: Yeah, of course. [00:21:58] Laura Yecies: ...if I gave birth to it. [00:21:59] Lindsey Dinneen: Right, right. [00:22:00] Laura Yecies: I am a user of our product, right? And I empathize with very deeply and connect with our patients. And I think if a, a 25 year old man were sitting in my shoes trying to raise money, maybe he would've even had a harder time. So I, I know. I don't know. Women's health has been under invested in, I believe it still is under invested in. And why is that? It's very hard to tell. I will also say that devices are a harder field to raise money for, independent of gender. There's more investors investing in digital solutions or pharma than devices for a variety of reasons. The size of the device investor market has shrunk. [00:22:51] And I think that's unfortunate and because I think there are a lot of solutions that are less invasive, less systemically invasive. Osteoporosis or osteopenia is one example. But we see devices for other women's health areas like pelvic prolapse or stress urinary incontinence, or a number of things that are of concern to women, but also things that affect everyone like migraine and these device solutions are very safe. They don't completely replace pharmacological solutions, but I think it's really important to have other options and so I do think it has been challenging, especially in the early stages in that field. [00:23:37] Lindsey Dinneen: Yes, exactly. Yeah. But I thank you for your perspective too. It is, I think quite refreshing to hear from somebody who was a woman who went through this raising capital and actually did have a really good experience, 'cause you hear so many of the opposite, so sometimes it's easy to go, "oh gosh, it's not changing fast enough." But it is so encouraging to hear from somebody who has had a really good experience, so I appreciate your telling me about that. [00:24:03] Laura Yecies: Yeah. And for women's health if most of the investors are men, a good investor should be able to appreciate concerns outside of their personal experience. But I think human nature is such that we tend to connect with problems that we've had. And so the fact that most of the VCs and investors are men makes the whole women's health field, I think, more challenging for fundraising. But we'll see. That's changing too. [00:24:35] Lindsey Dinneen: Yeah. Absolutely. Yeah. . So what are some things that you are excited about, either personally or professionally in the coming, coming couple of years? What are, what's gonna, what's gonna get you up and ready to just tackle the day? [00:24:52] Laura Yecies: Yeah. It kind of goes back to what we were talking about before that most of my career I've spent more on the commercial and marketing and sales side. And since I've been at BHT, we've been very much in sort of science and research mode, which has been very interesting, fascinating. I've enjoyed it, but I'm really looking forward to this next phase where we can get the product on the market. I mean, I hear from patients multiple times per week. "When is this gonna be available?" And I don't like saying "it's not available today." [00:25:27] Lindsey Dinneen: Yeah. . Yeah. [00:25:29] Laura Yecies: I wanna say today, and that feels tantalizingly close. I'm very much looking forward to that. And, first doing it at a small scale, we have a waiting list of patients. And I wanna, kind of put a shout out on that. We will first go to the waiting list. To make the product available and people can sign up at bonehealthtech.com and the front of the line are the patients who, the citizen scientists who participated in our pivotal trial, and they're, we have another trial going on. They're first in line. They have contributed so much and did it really out of a total generosity of spirit. They had minimal compensation. And then of course to get to the next level of, hitting the gas and growing the availability and distribution of the product. I'm imagining, I talked about hiking before and that's because I love to hike and I'm imagining, osteo boosting hiking groups or something like that. I know that sounded corny, but. [00:26:27] Lindsey Dinneen: Oh, I love it. . No, it's fun. And that is so exciting. I am really cheering you on as this next phase comes to reality. That's, yeah. That's incredible. Pivoting just for fun, imagine you were to be offered an opportunity to teach a masterclass on any subject you want. It doesn't have to be in your industry, but it can be, and you'd get a million dollars for doing so. What would you choose to teach and why? [00:27:00] Laura Yecies: I think I would want to teach around marketing and commercialization, sort of product management, and then really the full life cycle of bringing products to market. I've been doing it for 35 years. I hate to say that. Sounds like a long time in various formats. I mean, I've, some of it has leaned heavily on the digital marketing. Some of it has been more B2B sales, business development. So I feel like I've spent a lot of time in that area and I have lessons learned to share. I actually enjoy teaching. I spent some time, when I first came out to the Bay Area, I taught marketing at Santa Clara Business School. I enjoyed it, but I enjoyed working in the marketing field more, and I had young kids, and so between a full-time job and kids, there wasn't also time for teaching. But I would love to get back and do more teaching. And I do executive coaching and I informally coach and that's a very rewarding part of my job. [00:28:07] Lindsey Dinneen: Yeah, absolutely. That sounds like a great masterclass and very needed. So we would sign up for that one. [00:28:13] Laura Yecies: Thank you. [00:28:15] Lindsey Dinneen: And how do you wish to be remembered after you leave this world? [00:28:22] Laura Yecies: Oh I mean, I'm a family first person and I am lucky to have great husband, four kids and today's six grandchildren. And the first thing that goes through my mind when you ask that question is, to have had just a really positive impact on them and the other family members and friends in my life. And then, work-wise if this device or our solution is effective it provoke small changes, but in our field, small changes over time can have big results. And, if we've prevented fractures and help people, I would be really honored to be able to be known for that. [00:29:00] Lindsey Dinneen: Yeah, of course. And final question. What is one thing that makes you smile every time you see or think about it? [00:29:10] Laura Yecies: My grandchildren getting to play with 'em when they want, when they come through the door every Friday. [00:29:16] Lindsey Dinneen: Aw. [00:29:17] Laura Yecies: We have a family dinner almost every Friday night. And I look forward to it all week and when they walk through the door. So that's my mental image and I for sure smile with that one. [00:29:29] Lindsey Dinneen: Oh, I love that . What a great tradition. And I, it's so lovely that all your families, or at least some of your family, is close enough to be able to do that. How fun. [00:29:40] Laura Yecies: Yes, it's really fun. It's fun. And I grew up with that so I'm trying to continue, with the next generation. [00:29:47] Lindsey Dinneen: Yeah. Yes. That's fantastic. Laura, thank you so much for joining us and sharing about yourself, your background, and the incredible work that you and your company are doing. I'm so excited to see it come to market and just really impact lives. Thank you for the work you're doing. [00:30:06] Laura Yecies: Oh, my pleasure. And thanks for the chance to share it with people and for inviting me onto your show. [00:30:11] Lindsey Dinneen: Of course, and we're so honored to be making a donation on your behalf as a thank you for your time today to the Equal Justice Initiative, which provides legal representation to prisoners who may have been wrongfully convicted of crimes, poor prisoners without effective representation, and others who may have been denied a fair trial. So thank you so much for choosing that charity to support. We just wish you continued success as you work to change lives for a better world. [00:30:40] Laura Yecies: Thank you very much. [00:30:41] Lindsey Dinneen: Thank you, and thank you also to our listeners for tuning in and if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two, and we will catch you next time. [00:30:55] Ben Trombold: ​ The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Richard "RJ" Kedziora, co-founder of Estenda Solutions, dives into the inspiring world of digital health solutions, where innovative minds are not just developing technology, but also saving and improving lives. RJ shares his journey from early software development days to creating impactful healthcare technologies, highlighting the importance of understanding patient and provider needs. With a focus on people and process management, RJ's story is a testament to the power of technology in making a tangible difference in healthcare through human compassion and the drive to better lives. Guest links: https://www.linkedin.com/in/rjkedziora/ | https://estenda.com/  Charity supported: Save the Children Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 025 - Richard "RJ" Kedziora [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. [00:00:50] Hello, and welcome back to The Leading Difference podcast. I'm your host Lindsey, and I am so excited to welcome as my guest today, Richard "RJ" Kedziora, co-founder of Estenda Solutions, focusing on people and process management which also provides strategic technical direction, guidance, and innovative insights, creating digital health solutions that improve patient outcomes, reduce costs, increase efficiencies, and improve patient provider satisfaction. RJ received an MBA from Westchester University and a BS in Computer Science from Duquesne University, where he received the excellence in computer science award. RJ is a frequent podcast guest, has spoken at numerous technology and healthcare conferences, and has coauthored articles in technology and peer reviewed clinical journals. [00:01:37] Welcome to the Leading Difference, RJ. And RJ, I would love if you would start by telling us just a little bit about yourself and your background. [00:01:46] RJ Kedziora: Yeah, Lindsey, thanks for having me. It's a pleasure. I look forward to our conversation. My background is through software development. Graduated with a computer science degree back in, in the early nineties before web and mobile and internet. So crazy days. And came up through those software development racks. Started out programming, got into requirements analysis, understanding what a solution is about, project management, general management. And then in 2003, with a good friend, we were working with together at a large consulting company in the pharmaceutical space, we went off and started our own company called as Estenda Solutions and remain there today. We just hit our 20th anniversary, which is always crazy when I can talk about decades, but it has definitely been an interesting journey. So my day to day is, I think of it as a digital solution architect. So helping a mix of large companies and small companies, startups develop tools, technologies, algorithms, better ways of looking and dealing, handling data, to make a difference in the lives of people. [00:02:56] Lindsey Dinneen: Wonderful. That's incredible. So 20 years. Congratulations. That's no small task. . So I commend you for that. That's really exciting. I. Yeah. So how did the idea to start your own company come into being? Did you identify a gap basically in the market? [00:03:15] RJ Kedziora: It's something probably even early on as I was graduating from college, always in, in the back of my mind to make a difference, to go off and try something new and really drive what I wanted to do. Even before starting my own company, as I worked in various different roles, I'd be hired by a company, I'd come in with a defined role, and then I'd always just find a niche. They'd be like, "okay, where does this company need help? Where can I make the biggest impact?" [00:03:40] And that's how I went from software development into like more of the analysis and project management , 'cause I quickly realized software development, developing a digital product, it, you know, technology is important and you have to understand how to program and how to test, but it's very much about the people, the process, understanding what they're going through, and realizing those things. It was sort of a natural evolution of like, "okay, I need to strike off on my own and really drive projects and things like that with my talents and capabilities and now our team's talents and capabilities." [00:04:17] We were fortunate in those early stages to have a Congressional grant for the development of a diabetes disease management application for military healthcare. That's how we got our start. So we worked with people like Walter Reed Army Medical Center, the Boston VA, the Indian Health Services, which is responsible for the Native American population here in the United States. Still working with 'em 20 years later, which is crazy that we have 20 year clients-- bunch of other clients that we've been working with, 10, 11, 12 years a across the board. So, it's been enjoyable from that perspective. [00:04:53] And I always talk about, I've developed accounting systems, I've developed inventory management systems. And even a railroad car scheduling system, it's like, "Hey, great. We need to get that railroad from here to here. It's important!" You know, it's essential and the economy's important. But healthcare, there's that sense of giving back, of making a difference. [00:05:16] Lindsey Dinneen: Yes. Absolutely. Yeah, I, that is one of the things that I really enjoy about being in this industry is you're right all of those things matter that you could do with your skills, because obviously you have those skills and can use them in all sorts of capacities but in healthcare and med tech, it's this really great extra layer of feeling like you really are able to impact people's lives directly. And it, it just, it has a different sort of feel to it. [00:05:46] RJ Kedziora: Yeah. And our projects are typically on the R&D side, work, working with the R&Ds, working with academic medical centers, work with PhDs, with doctors, where they'll have an idea. It's like, okay, here's a different way of treating a patient with diabetes. A different way of looking at the data that you can collect around diabetes or other chronic conditions. I, I wear the Aura ring. It's there's a lot of data that's available there now. And so as we develop those solutions, it's one thing for us and the doctors, the PhDs, the corporations we work with to say, "okay, yes, this really works." But they, you know, they have to go to clinical trial. They have to go and do, they work in the real world. So we also have a couple PhDs on staff to help drive those discussions and do the planning around those clinical trials. [00:06:34] And ultimately, in certain situations, things then have to go to the FDA to be approved and validated. These days, there's a new terminology called digital therapeutics that we're getting heavily involved with. It's a relatively new term, probably 2017, 2018 that came around. And if there's probably 300,000 digital health applications out there. Systems, you know, some of which we've helped create over the years. But there isn't extensive clinical evidence that they work. There's some, but not extensive, and I think of it as the difference between, supplements and prescribed medications. And so there's lots of supplements out there. You can go to your CVS, your Rite Aid and pick them off the shelf, and there's some evidence they might work, but the evidence isn't exactly clear. [00:07:25] But then you go to prescribed medications, go through a very extensive, rigorous process of development of clinical trials, and then the FDA or other global regulatory bodies look at these and say, "okay, yes, this does make a difference." And that's the idea of digital therapeutics today is there are lots of digital health applications out there, but now people are taking these digital therapeutic applications: evidence-based, clinically validated, approved by regulatory bodies that can be prescribed by your doctor, by your provider. And more importantly than reimbursed by the insurance company. So making a difference. [00:08:05] You know, and we talk about health, healthcare, and being able to make a difference. There's not enough healthcare professionals out there, particularly in mental health. There's a mental health crisis in the United States. We just can't train enough people fast enough. Digital health is a way to approach that, to scale, to increase access and equity to these systems, to the care and treatment people deserve, and so that's the idea of digital therapeutics. They can get out there, provide this treatment, share the information with your provider, and make a difference. [00:08:38] Lindsey Dinneen: Yeah, absolutely. So what does it look like when somebody comes to you and says, "Hey, I have this idea for this app, for this software, whatever." And then how does it work when they start approaching you, and this is a brand new, never before , you know, project and you step alongside them. How does that work? [00:09:00] RJ Kedziora: Yeah, it is. It is a great question. And we work with a mix of Fortune 50 clients, so big customers, global customers, lots of people, processes, technology. We do happen to be ISO 1345 certified, which quite simply means we have a, well-developed quality management process of how we do software development, very template driven, process driven. It's like, here's how we're going to do it, and then we demonstrate that we do it. We get audited regularly by external third parties, by our clients. [00:09:32] But then we also work with startups who, in some cases don't really understand software and don't understand regulations and what's required to create one of those digital therapeutic applications. So when a customer does come to us in the, in those early stages, it's very exploratory. It starts out with prototyping understanding the problem in the domain space. One of the things that differentiates Estenda from a lot of other companies is we are going to provide the entire development team, software developers, QA from the ground up, educational training, medication training. So if you're working in diabetes or congestive heart failure or lupus, multiple sclerosis, the better the entire team can understand the condition, have empathy for the patient, can understand the provider, the care professional's journey about what they're dealing with and how they can care and treat that patient, the better off they're gonna be. [00:10:27] So it's those early stages of experimenting and playing and we start with, you know, black and white wire frame diagrams and really get those going and gradually build them up. And I think about it as you, you have a problem and you want to get across town as fast as you can from one end to the other, and you can walk. Great. Okay. But it's not very fast. Okay? I have this idea for a car. I can get across town really fast, but it's gonna take a long time to build that car and realize value. So, let's first build a skateboard. Very simple, can do it very quickly, provide value, get feedback, from the stakeholders, from the customers, from the patients, from the doctors, the nurses, whoever we're developing that application for. [00:11:15] And so you figure out the unknowns, you know, so what, aren't we sure? What areas are showing promise? So we build that skateboard and then it becomes a scooter with a handlebar, you know, okay, I'm getting across town faster. It's not the ultimate goal. But I can get there. And then you can build a simple motor on it,, and then you build a body around it and you progress gradually until you get to that car. But along the way, you're adding value very quickly, which is important. [00:11:47] Lindsey Dinneen: Absolutely. Yeah, that sounds like a really good process to work through. And I love your illustration. That's such a great way of capturing the essence of the process and the way that you go through all of that. So, I'm curious, have you always had an interest in and passion for computers, technology, software development, or is this something that evolved over time? [00:12:08] RJ Kedziora: Yeah, I was very fortunate. My parents were able to buy an IBM PC Junior when I was in probably seventh grade in the mid eighties. I went to a local parochial school. They had a computer lab, you know, as one computer in the classroom. But, for the eighties, that was phenomenal. And so I knew going into college that I wanted to do software development. A good friend had a Commodore 64, which is typically a gaming, and so I'd be over there and it's like, "okay, games are fun, but what can we make the computer do?" You know? So I was very early driven by what can I do and the possibilities of digital everything. [00:12:49] College, I really thought I was gonna go and get the PhD in artificial intelligence. Very much enamored with that idea. Ultimately as I got ready to graduate, I got offered a job and was like, huh, money and so that, that turned my, you know, immediate trajectory there. You know, I did start working in programming kind of thing, but always followed AI and things and applied those ideas and principles and what AI is, has evolved a lot over the years. We've developed some AI systems in the past, but you know, now when you look at them, they're really like rules engines, and think things of that nature. And they were considered AI at the time, but nowadays it's like, "okay, that really wasn't AI." [00:13:36] But you know, the idea is, and the principals were there, and one of my senior thesis projects was genetic algorithms and how do you apply the idea of genetic algorithms to solving computer problems? And that was at the early stages of the internet kind of thing, just as a browser were coming out. So that made research interesting 'cause you could even at that early stage reach out globally to people and seek ideas and thoughts and stuff like that which led me down that road. But fast forward 30 years now and AI is everywhere. It's all that, that the media can talk about these days. Rightfully so. [00:14:15] Lindsey Dinneen: Yeah, and actually that brings up a great question that I had for you, because I did notice on your LinkedIn, you do share a lot of articles about AI, and you're obviously very involved in that. How have those tools helped your work or how has it changed your work or whatnot? How do you feel about all of that? [00:14:33] [00:14:33] RJ Kedziora: It really comes down to data. That's the core of AI. In the past and today, you need data to be able to train the AI systems to do what they're capable of. And it's interesting, our journey as Estenda is, as I've been reflecting on it was one of data scarcity. You know, 20 years ago, getting data was the difficult challenge. In diabetes, it was typically finger sticks, and people would, you know, do it a couple times a day and EMRs were there. They existed. We were lucky working with government organizations that had them, the military, the VA had them. Now it's, you know, fast forward 20 years later, there's an overwhelming amount of data. So early on it was like, how do you make decisions with limited data? Now it's like, okay, how do you use all of this data and pick out the important, salient things to be able to make decisions on and drive recommendations, [00:15:29] And the same thing is true with AI today. As you're developing a system, you need a robust set of data to train the AI systems. The broader data that you have, the better off you're gonna be. Day-to-day. I think today, generative AI, you know, the Chat GPTs, the Bards, what everybody's really, the media is talking about are amazing. You need to know and understand how to use these tools today. And it's not so much where they are today because there are challenges, there are problems, you know, they make up stuff. It's called hallucinations. And so you do have to fact check what they do. It was interesting is I was sharing, we do a monthly all staff meeting kind of thing, and I was sharing my experience with chat GBT and one of the people on the call sort of googled, like, tell me about Estenda. And it made him the president of the organization kind of thing. It was like, he's a great guy, does amazing work us, he's not the person. And it was just one of the odds of that, in that moment, kind thing. It was like, yeah, that's not true. [00:16:34] Lindsey Dinneen: Right. [00:16:34] RJ Kedziora: So you do have to fact check it. But that's today and where we are. And so imagine where we're gonna be 10 years down the road. And Bill Gates said a long time ago, "Humanity overestimate what technology will be capable of in, in the 18 months, two years, underestimate where it's gonna be in 10 years." And I think about Estenda, if the iPhone didn't exist, Facebook didn't, Instagram, Twitter, X, none of these things existed when we started, and here we are a short 20 years later and the world's changing. In terms of AI now it's really an efficiency thing. And it's like, "okay, I need to do some blog posts." And yeah, I can sit there and come up with the blog, post ideas, but it's like "Hey, ChatGPT, gimme 10 ideas for blog posts," you know, and I might not like four of 'em. Okay, "gimme four more." I don't like this. "Gimme four more." [00:17:29] You know, and it's just, it's an efficiency thing. Even in healthcare, that's what we're seeing. So there are, a lot of, I think it's over 400 now, approved, FDA approved AI algorithms very much in the idea in the area of radiology and looking at images. That's by far the biggest use of . Today, if you have those images, you can train systems to recognize certain things, you know, whether it's breast cancer or diabetic retinopathy. You can train systems to recognize what you need to see in those images instead of a person looking at them all the time. So, again, you can scale much more effectively, which is nice. But in, in healthcare it's very much, it's that efficiency question. [00:18:09] Lindsey Dinneen: Yeah. [00:18:10] RJ Kedziora: It's like, okay, I know how to write a prior off letter for this patient, but that takes time. So have ChatGPT write the prior off letter. And then you as the physician, the trained professional, have to look at that and evaluate. And you can't just send it off. You do have to look at it, but you know, EMRs, there's a plethora of data in the EMR. Let the AI systems... [00:18:35] Lindsey Dinneen: Yeah. [00:18:35] RJ Kedziora: ...you know, surface what is important, is a challenge. EMRs is a general idea, are very much around capturing data for billing, not the best, usable experience. If you can use AI that's just listening in the room to then document that encounter, that provider's now not heads down on the computer typing, trying to make sure they get everything in and not looking at the patient and not paying attention to the patient. [00:19:02] Lindsey Dinneen: Right. [00:19:03] RJ Kedziora: It can reverse this kind of thing. It's like, okay, the doctor can now pay attention to the patient and look at that person and really understand their situation better and pick up on those cues of just their body language kind of thing, and not have to worry about typing away at the computer. And then there's a lot of duplication in clinical records. So it's like, let the AI systems get rid of that duplication, make it better. And then just, you know, enhance. And I saw an article, I think I posted about it, the idea of collaborative intelligence, but a lot of people are asking is, AI going to replace Doctors, software programmers, software developers, insert profession X, is AI gonna replace it? And then people are like, "AI is not quite there. AI makes mistakes. It has biases. AI Hallucinates." [00:19:50] I love my doctor, but my father has said over the years, " the doctor that graduates last in his medical school, what do they call him? Doctor!" You know, they're human. That, and that's what it amounts to. It's, they provide a great service, but they're human too. And they might not recognize everything. And so if we work collaboratively with the AI to balance that out we can improve overall care and treatment. So. [00:20:18] Lindsey Dinneen: Yeah, so a lot of potential for it, and I love your idea of using it for some of those more tedious, time consuming tasks and just giving you your first draft because it's not, like you said, it's not gonna replace the human. Let's look through this. But it can help. And if you're using it appropriately, there's a lot of good uses for it too. So, yeah. So, you know, there's a couple of things that I noticed from your LinkedIn profile I'd love to chat with you about. One of the things that stood out to me was in your headline, you mentioned Chief People Officer as being most important. So I would love if you would speak a little bit to that and why you feel that way. [00:21:00] RJ Kedziora: I can do a lot, but I can't do everything. So I, the people that work for us are very important. I can make an impact. A team can make a much bigger impact. A company can make an even a bigger impact. So that is, that's why they are important. I talk about family first a lot. And, we provide fully paid healthcare benefits for you and your family. You want to have that sense of safety, want people to feel that they can take risks, and do their best work kind of thing. And the better they feel, that emotional safety, that the better off we're gonna be as an organization. They'll be able to provide more value to that customer, be more productive, 'cause ultimately that's what it amounts to is we need to get software out the door. We have customers and clients that have needs and demands and we have to meet those, but you know, you have to balance that with life. So. [00:22:02] Lindsey Dinneen: Yeah, absolutely. And I love the emphasis on people first, and I'm, I'm wondering if that's something that, is that an ethos that developed over time for you as well as how did your leadership skills evolve? Because going from starting a business to then and then growing it, I mean, it's a whole thing. So, yeah, I'd love to hear a little bit about that. [00:22:24] RJ Kedziora: Yeah, it definitely has grown and evolved o, over the years. It there, there's this concept of being a 10x software developer, one person making the impact of 10 people. And that's somewhat of a myth, but there are people that are more productive than others. And the idea of empathy and understanding that other person's perspective and experience is what's driving to that next level to become that 10x developer. You're not developing for yourself. You're developing for the end user, but we embody it in, we have a professional development process, and the idea of helping others is embedded in that. [00:23:01] You'll see that we do one-on-ones, not as great, as frequently, as I would like. But we try and do those. But as part of our structured plan, we do a self-assessment and we ask everybody that question, "how have you helped other people?" as part of the goal process, "how are you helping others?" But even as you're developing in that day to day when you're writing code, "how is it helping you in the future understand what you're doing? How does it help the tester better test that software? How does it help the support person provide better support?" [00:23:37] So it's really thinking about how you're helping others along the way. And ultimately the whole company is driven by that of working in healthcare. But it starts at that bottom of every person. It's like, "how, what you're doing, helping the next thing?" So we try and constantly reemphasize that when we can. [00:23:54] Lindsey Dinneen: Yeah, that's a great approach. And so, and because that is so much the heart of your company and your people, I'm curious if there's any particular moment that stands out to you as you've gone along this journey, that kind of really reinforced, yes, this is why I am here doing this work. Is there anything that, or a series of moments, just things that really stand out as being a very sure "yes, this is correct" for you? [00:24:20] I [00:24:21] RJ Kedziora: Yeah. It, I would say it's more a series of moments, because as we've developed software and then it's used by the care providers or patients, we've constantly over the years, hear those anecdotal stories of "Hey, I was using your software, what you developed for us, and found this and helped this patient." There's a series of those, but then it even goes up, it bubbles up that we do those clinical trials and we've done five year NIH funded National Institutes of Health funded RO one study. So it's like a five year study to then demonstrate that the software we produced does make an impact kind of thing. [00:25:00] But even more importantly, as we're part of that process, we've had several customers put our names, our developers' names on patents, or as those articles have gone to clinical journals, peer review journals that our software developers and QA, other staff have been authors on those. That, that's just rewarding where, okay, yes, we are helping people, but then our customers are also recognizing how much of a part of this journey we are. You know, if you really know what you wanna do and have it, here's my 10 requirements kind of thing. We're probably not the company for you. Let's explore and create something together. [00:25:38] Lindsey Dinneen: That's really cool. So it's always a collaboration it sounds like with your clients. It's not just a one way or the other, them dictating to you or you dictating to them. It's this, let's figure out the best way for us to work together. [00:25:50] RJ Kedziora: Yeah, it says how do we add value? How are we, you know, we want to contribute. [00:25:56] Lindsey Dinneen: Yeah. That's amazing. Yeah. So, one other kind of random question. Based on your LinkedIn profile, when's your next triathlon? [00:26:04] RJ Kedziora: How much time do you have? [00:26:06] Lindsey Dinneen: Yeah. [00:26:06] RJ Kedziora: I, yeah, that's a whole 'nother podcast. [00:26:08] Lindsey Dinneen: Yeah, sure. [00:26:09] RJ Kedziora: I think I'm, I think I'm, I think I'm done for this year. I live in the Philadelphia area, the temperature's getting, yeah, temperature's getting a little colder and that type of thing. But, you know, take a little rest for a month or two before I get back into training. And, but there are definitely ones I do every year. There's one escape from Cape May, Cape May, New Jersey. You jump off the back of a boat, the ferry, into the ocean and swim to shore. I did escape from Alcatraz two years ago, which is interesting because they take you out in a boat, in, into the. And jump off the boat from Alcatraz and swim to shore. Always interesting kind of thing to, to do those, but it's very much-- it's interesting because my day-to-day at Estenda, my own company, and how I get involved in projects is 'cause I enjoy the challenge of it. [00:27:00] And in triathlon, yes, there, there's a definitely a physical aspect of training and, but it is also very mental to, and that's really what I think drives me in the sport of triathlon. It's like, "okay, I need to get up at 4:30 and go jump on the pool and swim for 45 minutes and then hop on a bike" time and time again. And I thoroughly enjoy it. But yeah, it is that mental challenge. I've done just pure marathons in the past and it's like, "okay, get to the next telephone pole. Get to that next half pot." It's that mental, keep pushing kind of thing is drives me. [00:27:34] Lindsey Dinneen: That's incredible. It just reminds me-- tangent very quickly-- it reminds me, I remember I was running a 10k with my husband and I'm not a runner, I don't claim to be, but I was doing this challenge for myself, and I just remember we, we were getting close and I was so exhausted and, you know, kind of miserable at that point. And he was like, "it's all downhill from here. It's all downhill." And I was like, "it's literally sloping up!" [00:28:00] RJ Kedziora: Yeah, but it's, you know, it's like, yes, for me, try, it's hard. It's difficult kind of thing. but I'm also good enough that I'm not out there it's like, for a a marathon, I can-- in the past it was like 3:20 for a marathon. [00:28:16] Lindsey Dinneen: Wow. [00:28:17] RJ Kedziora: But there are people out there that are five hours, six hours. I think that is so much harder, so much dedication for that individual to be out there for five hours. It's kudos to you for being out there for, you know, it's like, yeah. I'm not saying I, I have an easy time of it by any means, but I'm not out there for five hours and they did it. So I just, I'm astounded by those people and they're not on the couch. And I know I, I look to have a long lifespan and a long healthspan. I want to hit a hundred years, but with a good quality of life. And I have a couple friends that are in, still out doing that 5k at 70 years old, and they're like, "I won my age group! I was the only one in my age group..." but you weren't on the couch! Like you did it! And that's motivation to, to keep going out there as well. So hopefully I'll be that person. [00:29:10] Lindsey Dinneen: I love it. That's brilliant. Excellent. So, pivoting just for fun, but imagine you were to be offered a million dollars to teach a masterclass on anything you want. It can be in your industry, but it doesn't have to be. What would you choose to teach and why? [00:29:29] RJ Kedziora: Oh wow. It would probably be about health. [00:29:34] Lindsey Dinneen: Okay. [00:29:35] RJ Kedziora: Which, which combines sort of everything I do. The triathlon, the training, the fact that I'm in software development in the health field. It brings all of those things together. And just a lot of people don't know what they don't know. And so if I could impart that knowledge on more and more people, I think that would make an impact that would make a difference. So yes, I could teach a software development course on cybersecurity. Interesting.. I could teach one on AI. Yes, interesting. But if it, if you really just focused around the idea of eating better, moving. You don't have to do a triathlon, you don't have to do a 5k. And it's like park a little further away from the supermarket and walk. You're gonna be better off, have that longer lifespan, longer health span. So yeah, it's, if I have that million dollars and it is probably health in in general, which encompasses a lot. But yeah, it would be health. [00:30:37] Lindsey Dinneen: Yeah, absolutely. Yeah. And then, how would you like to be remembered after you leave this world? [00:30:44] RJ Kedziora: Huh. Wow. Then I've made an impact and I've made a difference in, in some small way. I don't have to win the lottery, I don't have to be the billionaire kind of thing, but that, that I've made a small impact and, the lives of the people around me and hopefully a bigger audience through the work that I've done, that our company's done. And yeah, I've made a small difference and made a few people laugh. [00:31:12] Lindsey Dinneen: Yeah. Yeah. I mean, I've already laughed today. So , you're succeeding. Excellent. And then final question, what is one thing that makes you smile every time you see or think about it. [00:31:26] RJ Kedziora: Family, I, that's, you know, wife. I have two daughters, 24 and 21, doing very well. Yeah, any chance I get to see them? Family. [00:31:36] Lindsey Dinneen: Yeah. [00:31:36] RJ Kedziora: And oldest of six. So you get to see them and their family kind of thing. Family's important, yeah. Yeah. [00:31:43] Lindsey Dinneen: Yeah. And you've mentioned that several times: family first and people first. So it's a running theme. . That's great. RJ, this has been so much fun. I really appreciate your time today and just thank you so much for joining us. We are so honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational and safe environment. So, thank you so much for picking that, that organization to support and we just wish you continued success as you work to change lives for a better world. [00:32:24] RJ Kedziora: Thank you very much. This was a great interview. Thank you. [00:32:27] Lindsey Dinneen: Excellent, excellent, and thank you so much to our listeners for tuning in and if your feeling is inspired as I am right now, I'd love if you'd share this with a friend or two and we will catch you next time. [00:32:38] Ben Trombold: ​ The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Dr. Scott Bertrand, the inventor of the AllCore360 therapy optimization platform, shares his journey, beginning with two significant spinal injuries that led him to question conventional physical therapy methods and ultimately steer his career towards chiropractic care and MedTech innovation. He discusses his invention, which revolutionizes core training by focusing on isometric exercises, benefiting a wide range of individuals, from spinal injury patients to elite athletes. Scott's personal experiences and challenges fuel his passion for MedTech and his desire to impact lives positively. His story is one of perseverance, innovation, and the power of using personal challenges as catalysts for creating solutions that can change the world. Guest links: www.allcore360.com Charity supported: Sleep in Heavenly Peace Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 024 - Dr. Scott Bertrand [00:00:00] Lindsey Dinneen: ​ [00:00:05] Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:14] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:20] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:33] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:43] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:47] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. [00:00:55] Hello, and welcome to The Leading Difference podcast. I'm your host Lindsey, and I'm so excited to introduce you to my guest today, Dr. Scott Bertrand. Scott is the inventor of the AllCore360 therapy optimization platform, and currently the chief research officer with AllCore360 America. He is retired after 35 years of caring for the chiropractic needs of a wonderful community in south Atlanta. He is a proud a 101st Airborne veteran and honored member of Mensa, but most importantly he's married to his wonderful wife, Lori, has two incredible children, Stephanie and Luke, who have blessed him forever with five precious grandchildren. Thank you so much for joining us today, Scott. I'm so excited to have you on the show and hear from you. [00:01:40] Dr. Scott Bertrand: I appreciate the opportunity to speak with your audience and to you. [00:01:45] Lindsey Dinneen: Excellent. I would love, if you wouldn't mind starting off by telling me just a little bit about yourself and your background, and let's start there and then we'll get into some of the other fun things. [00:01:58] Dr. Scott Bertrand: Let's go back to where probably my medtech life started. I had two separate spinal injuries that kind of thrust me into the healthcare world. One when I was 19 years old and I had a fracture in my lumbar spine, and when I was 19, I was brought up in a blue collar, middle income family and my parents, you know, believed that medical providers were set next to the Pope. I, it was whatever they said, whatever they did, that's how we looked at it. And I thought, I felt no other way. I had, I'd injured my spine and fortunately I wasn't paralyzed at all, but I was definitely beat up and pretty painful. [00:02:36] But I went into the therapy process at that time just excited to recover. In my mind, the medical doctor would fix me. That's all. I mean, I knew I was broke, but that was his job, and I believed that's what he would do. He goes on and, you know, I'm not putting fingers at anybody. I realize that he was doing the best he could with what he had at the time he had. So I, I'm not, this isn't anything negative, but he refers me to a physical therapist, of course, which he would. I excitedly go to my physical therapist and instantly he requests me to do things that were incredibly uncomfortable, very painful. And I remember kind of leaning back and going, "whoa, wait a minute, that this problem isn't a good thing. This is quite similar to the trauma. Let's probably not do that." But, you know, he kept insisting that I needed to do these movements, and these movements were brutal. [00:03:30] I was 19. I was an athlete. I had been in the 101st Airborne. I was a, I guess you could quote, kind of a tough guy, but, you know, this was incredibly uncomfortable. And I, I finally, after several visits going back and forth with him and complaining that this was obviously not the right approach, he just looks at me and says, "Hey, you know what, Scott, what you need to do is suck it up." And, you know, this really wasn't a suck it up thing. I mean, I know what suck it up is, [00:03:57] Lindsey Dinneen: Yeah. [00:03:58] Dr. Scott Bertrand: That really wasn't it. And I was incredibly disappointed and everything just kind of fell into my like, oh my gosh, maybe they don't know everything. It was kind of a, oh my gosh moment for me, but I ended up going, you know, this isn't gonna work for me. I'm gonna have to, I'm gonna have to quit. [00:04:14] And so I look over at him and he takes a stamp and puts "non-compliant patient" stamp on my file. I remember going, wait a minute, I'm not "non-compliant." There's nobody that wants to get healthier than I do. He released me and that's how I was. That's my name. I'm a noncompliant patient. So I was really frustrated at that time and I thought, this is really not right. I, but what it did do though, is it focused me in healthcare. You know, I'm a young man and I'm not sure what my career is gonna be. I don't know what I want to do in life exactly. But I went, oh my gosh, some missing links here. And I, at least I need to know more about it for my own self, you know, my own health. [00:04:54] So I started pursuing a career in health, and I ended up going into the chiropractic profession because I had injured my spine. And these people seem to be the ones that were the spinal professionals. So I go to school I'm going through this process. I'm learning about the spine and the body, the miracle machine we drive, which these are the first kind of early things that are going off in my mind going, oh my gosh. We're blessed with a miracle and we're just trying to learn how to take care of it. [00:05:23] I'm getting ready to graduate from chiropractic school. I'm at my brother's wedding. I dive off the high dive. I shouldn't have been up there to begin with. I hit somebody in the pool and I break my neck. Okay? It's like, oh my gosh. Here we are again. I'm thrust into this space again. I'm not paralyzed, [00:05:38] Lindsey Dinneen: Oh [00:05:39] Dr. Scott Bertrand: and I say that because I've treated and worked with so many people who are... [00:05:42] Lindsey Dinneen: Yeah. [00:05:43] Dr. Scott Bertrand: That I don't wanna put myself in that basket. I wasn't, but I was, you know, it was a shocking experience to say the least, and incredibly uncomfortable, and it took a long time to heal, but it's been a good eight, nine years since the first trauma, and now I'm almost a chiropractor. I'm graduating from chiropractic school. So I've got a really strong background, at least anatomy and physiology and how the body works, and excitedly. I go off to therapy again, and I look across the table and he asked me to do the same movement again that they recommended 10 years ago. [00:06:13] I'm like "whoa, wait minute. I know that doesn't work. Let's not do that. What else do you have?" " No, that's what we do." And I go, " no." And we went back and forth. And then he said to me, Scott, "you need to suck it up." The second "suck it up" got me to walk out of there and say, "look, there's something massively wrong with how we're treating this. I don't know what it is yet, but there's something wrong and it needs to be corrected." [00:06:36] Medtech is coming up with some innovation that addresses a concern in the medical world that hadn't been addressed that way before. So there's a long process between "I have a problem and I'm trying to figure it out," and "I come up with a solution." I don't wanna underestimate the time that requires. There's a long gap of time in there, but then, okay, now we have a solution. And I guess really, Lindsey, that's kinda where it starts. I invent the AllCore360. That's an interesting conversation if you wanna go into that. But that's what threw me into the MedTech industry. [00:07:10] And that's where I realized that, when you come up with something in MedTech industry, it's not like a better windshield wiper, which Lord knows we might need better windshield wipers, and that's good. But when you're impacting people's lives and the way that we got to do that, and it's a global reach. It's not just like across the street, across the neighborhood. When you can impact a human being, there's a strong possibility you can impact us all. The awareness of knowing that I can help the world was the motivation in everything. That really was, I think, that's what drives everybody in the medtech industry. [00:07:44] It's an innovation that can impact society in a way that it needs, but it can do it on such a grand scale and it's not . I know you have a lot of medtech industry, so I know I'm preaching to the choir, but it's not about money. You'll be rewarded certainly, but you'll spend your money, but I'll never be able to spend the hug from the mother who I took care of their daughter and help her to walk. Not only does, I can never spend that, that just gets interest. That just gets better and better, and then they tell somebody else and it grows and it's, it's a, it's just a wonderful industry to be in. Tough, hard, really hard, but oh my gosh, are the rewards amazing. [00:08:24] Just anybody in that space and is struggling and Lord knows I know how hard that is, please don't give up. It's so worth it. You know, we all say if we could just take care of one person. Back to what I said, if you can take care of one person, you can probably take care of 'em all. And that's, that is pretty exciting. And I've been able to do that. That's where we're at now. I've, you know, it's taken my whole life to get here and decades, but, you know, we're here now and we're really, I'm really proud and I could not be more happy with what the company and our team has been able to do. [00:08:57] Lindsey Dinneen: That was fantastic. I loved hearing it. I love hearing your background and what motivated you to get into this field, so thank you for sharing, especially some of those really personal stories of challenges that you had to overcome, which ended up being the catalyst for. This new stage. So I wouldn't, I certainly wouldn't wish those injuries upon you by any means, but I am, I want to recognize and thank you for taking those kinds of really challenging periods of your life, but using them as catalysts for good. I think that is very commendable and not easy. [00:09:34] Dr. Scott Bertrand: No, and I appreciate you saying that. And I kind of joke, but only a little joke that this kind came to me. This invention came to me after months and months of studying on all the issues I was trying to resolve in that kind of hypnagogic state. You know, that's that dream state. It actually came to me in a dream, and when I realized what it was, I realized that was a gift. I'm giving this gift, and now the job is to share that gift. You know, in medtech it's a lot easier said than done, but that's kind of the next step. And they know we've been able to do that. We finally have and it's been a blessing that I've thoroughly enjoyed. [00:10:14] squadcaster-bf62_2_10-20-2023_140435: Yes. Yes, absolutely. And like I said, thank you so much for sharing about that. And there's so many questions that I have that popped up from it. But I'll start with, I would just love to hear more about your company now and your incredible device and how it works and how it's changing lives. [00:10:32] Dr. Scott Bertrand: Oh, wow. Thank you for even giving me the opportunity to share that because that's unique and that's why, I guess it's an invention. It's not been out there before. So to do this real quickly, the, the design of the device is to train the core. And when I started, the core was an apple core. People didn't know what cores were. We used to call it the trunk, but anyway, it was, it's the core. And so what we're gonna call "the core" is from the base of your skull to your pelvic floor, that tube of muscles that is who you are. We plug arms and legs into it, and if you're an animal of flippers or fins or wings or whatever, but we're all just this tube of muscles that is that core. [00:11:12] And so the design of our, my device is to train that core. And so the, here's how we do it contemporarily. We take the core instead of, you know, really realizing we're a tube, we're a round tube. We call ourselves a box. I'm not sure where we came up with that, but now we say our tube has its front and a back, and a right and a left when tubes don't have front and back and right and left. But for some reason we called ourselves a square and then, and that was our first mistake, but we just all just accepted that like, "okay, um, our eyes are pointing forward, so let's make our box pointing that way." So what we did is we took this square, we decided what the square could do. [00:11:54] The square could bend forward at the waist. It can bend backward at the waist. It can bend to the right at the waist. It can bend to the left at the waist, and we're gonna challenge it that way to make it better. You know, I think what happened was people did that and they got better. There were, it does that kind of works. It wasn't a horrible thought. It was just a, an incomplete thought. So what the AllCore does is it takes this 360 degree machine, it's really a 360 degree machine that can go in any direction. It can bend and twist in any direction, and it takes it and challenges it in every direction. If we took our box example and we bend forward, bend backward, bend right, and bend left, that's four degrees. That's four separate degrees of movement. [00:12:40] We've only left out 356. What about all those other movements we just left out? And I'll tell you where one of the lights went off that I, this is kind of what makes it so unique, I believe. We are, we train the core isotonically, and by isotonically, I mean, we bend and twist and move. So right now, 99% of the people that run down to their local workout gymnasium center, they go in to do their core and they bend in half. Let's call it like a sit-up. They do sit-ups. When I was like 15, we were doing sit-ups, so you know, that's not anything new. Okay. And then they, we got really clever and we started calling our sit-ups "crunches." That's the same thing. A crunch is a sit-up, but we somehow thought that was even better. And then we went we can make a machine to do that. And then we had a crunch machine. But what we have, it's the same concept. It's bending in the middle of our bodies. [00:13:40] This was one of the, oh my gosh moments. They, one of these things that eureka moments, if you will. I walked out of the gym one day and I'm a gym rat. I live there. I, that's what I did. And I realized that . If for some reason I'd never walked into the gym, I would've never done a sit-up in my life. Sit-ups are not things we do. These are not positions we get our bodies into. There's no sport where everybody lays on the ground and bends it half 50 times. I started to go, "why in the world are we working so hard to do this one movement when we never ever do that movement?" [00:14:19] And I thought, "oh my gosh." My next Eureka moment comes in. Now I'm outta chiropractic school and I'm working really hard and I realize we're working with this miracle machine body and I, all of a sudden, I had to start laughing at the way we treat the body 'cause I was reading old medical journals and old history medical journals. I mean, there was a time when they thought smoking cigarettes made you a criminal. I mean, I know that medicine only took what we could take and we believed it and we taught it and we treated it. But what I really realized now, the things we think are true now may not be true in the future, unfortunately, but what I realized, what medical providers and medtech providers really need to do this to me became the bottom line. [00:15:02] We were blessed with this incredible healing miracle machine. To ever think that somehow our brain that read that book knew better than our body did on how to take care of our body was ludicrous. Our body knows how to do everything. We're the best survival machine on the planet. This machine knows how to heal. It knows how to do everything. In fact, it's a lot better if we just stay the heck outta the way. The more we get involved, the more we screw it up. So here's what I think physicians really need to do, and this is what I kind of decided to do at the medtech, is realize what the body does to survive. [00:15:43] Because that's really all it's about. It's about survival. There's no extra parts on the body. I mean, everything on the body has a survival value. And if you want to improve the body, you help the body in its ability to survive. So what I did was I looked at the core, and this is, these are these eureka moments. I looked at the core and I said, "what really is the survival value of the core? Why am, why do I have a core? I mean, what do I do with it that helps me survive?" [00:16:12] It dawned on me almost immediately. The core, as much as we think the core is designed for movement, there's not a lot of survival value to movement. I'll take that back and say, if a rhinoceros was coming after me, I need to step outta the way. So I understand there is a survival, I gotta move, but let's say I didn't move when the rhino hit me. How was I damaged? I was damaged by being bent around the rhino's head. My body went beyond its normal range of motion. So what really is the core designed for? [00:16:48] And here's the key. It's designed to isometrically maintain your posture in the most efficient, safe position possible. Your perfect posture is so perfect. It's almost hard to get damaged where you're in that perfect posture. When you bend to the left and pick up a weight, you took yourself out of the perfect posture and oh my goodness, he blew a disc. You know, you took your posture, got it out of position, and then challenged it. So that's not how you should challenge your posture. You should take your posture, put it in a perfect position, and then isometrically challenge it because that's how we use it: isometrically in the 360 degrees of its potentiality. [00:17:31] It needs to be able to do all those things isometrically, and at the end of the day, the AllCore360 takes your body, your only athletic ability has to have the ability to sit. You know, sometimes you go to the gym, you look across the floor and you go, "oh, that looks like a great exercise, but I know I can't do that." The AllCore, all you gotta do is sit and what that does is that adds everybody on the planet. That's your senior citizens. That's people in wheelchairs, that's people that don't have legs. It addresses so many people in the population. All you have to be able to do is sit and we can make your core better. [00:18:10] At the end of the day, like I said, the core is everything. So what's the survival value of the core? It's not to bend. It's to stop from bending too far, 'cause if you bend too far, something breaks. So what you do is you stop it from bending and you stop it from bending in every direction, and you do that isometrically. That's how you need to challenge the core in the way it was designed to perform. Once you do that, once you develop a very balanced, coordinated strong core, that core can go hit golf balls and baseballs and do anything it wants, but you can't train a core by hitting golf balls and baseballs and all those things. [00:18:49] You train the core the way it's designed to perform. You make it efficient and strong and high endurance and balanced. What you're really doing is taking your God-given miracle machine and making it the best it can be. As opposed to what most of us do is we take this incredible miracle machine and we beat it up until we kill it. So it's a better way to look at it. We really should take care of it. But yeah, so it allows most of the population, and 99.95% of the population treat their core in a balanced, optimal fashion and it only takes 10 minutes, three times a week. [00:19:29] One of the problems with therapy, and one of the problems with fitness is always I don't have the time. I don't have the time. My goodness. 10 minutes. It takes you longer to put your gym shorts on. All you gotta do on this machine for 10 minutes. That's how it works. And because of that, people really -- they're compliant. Back to my non-compliant patient status, if it's only 10 minutes, you can kick people to come and do 10 minutes. [00:19:56] Lindsey Dinneen: Yeah. [00:19:56] Dr. Scott Bertrand: To have someone come in and do an hour and a half, and now they need all kind of other things in their life that they can use for excuses. [00:20:02] Lindsey Dinneen: Right. [00:20:02] Dr. Scott Bertrand: 10 minutes isn't a big commitment for the remarkable, miraculous results it gets for some people. That's kind of how it works. And it's, like I said, it's a it's a blessing, and it started in this spinal cord injury space because what it did for people who only have their cores, I mean, this is what they have. They don't sometimes have arms and legs. This is what they have. So it started in that space, but when those patients and clients started sporting six packs and losing 10 pounds, all of a sudden, everybody wanted it. Everybody wants a six pack, everybody wants to lose 10 pounds. And that's great. [00:20:39] So we definitely are in this spinal cord injury space, this extreme rehab space, this weekend warrior rehab space. But we're also in that elite athlete space. We're at a lot of colleges, university, sporting clubs. They're seeing that, it's much better to prevent injury than always trying to fix it. Doctors go into the world praying that they get to take care of people and they teach 'em how not to get hurt. But really what they do, they get thrown into this world of broken bodies, the people that don't take care of their bodies and they don't listen to you and you never get a chance to teach them even how to take care of it. Right? So it was an opportunity for us to really impact lives. We don't need a lot of time, we just need you to show up and this, and it works that way. [00:21:21] Lindsey Dinneen: Wow, that is incredible. And yeah no, it is incredible, and I love that there are two extremely important case uses for-- more than two-- but I was thinking about it in terms of, like you said, injury prevention, just in general, health, wellbeing, physical optimization, versus also, then you have the Yeah, versus also, then you also have treating, [00:21:47] Dr. Scott Bertrand: Right. [00:21:48] Lindsey Dinneen: Right. Yeah. So I think it's incredible [00:21:51] Dr. Scott Bertrand: That opens up such a big market. [00:21:53] Lindsey Dinneen: It could exactly right because everybody could benefit from this. This is literally something that could impact everybody's life who participates. Holy mackerel. [00:22:02] Dr. Scott Bertrand: And the nice thing was, it's if you knew where there was one or you used one, I. What I get to do every day, although oftentimes it's cry because these stories are so overwhelmingly wonderful, but I get to hear on a daily basis almost about these recovery stories and it's because we weren't doing it right. It's not that-- I mean, I appreciate the fact the AllCore is the, it's my device and our device, and it's doing what we said it would do-- but it's the body. The body-- if you treat the body right, it just does the right things. It just needs someone to kind of just help it a little bit. It's a miracle. We just need to kinda encourage it sometimes, and that's what this really does. [00:22:43] And the, again, because it's the results and the responses are so rapid, people enjoy maintaining the schedule. And the longer you maintain the schedule, the more and more of those results improve. And once you finally develop a balanced core, like I said, I've been an athlete my whole life. But I didn't have a balanced core. I thought I did, but I didn't. And when I developed a balanced core, I was, I'm overwhelmed and I can, I can't tell you how many athletes that are starting to experience those same things. You would think an athlete would come in and get on our device and max it out, you know, show me something that, wow, only an Olympic athlete can do. But I can have an Olympic athlete come in and when they get on the machine, I can say to them straight to their face, "I've got a woman in a wheelchair that can make you look horrible." And that is the honest to goodness truth. What the core actually can do when it's taken care of is an amazing thing. [00:23:43] I wanna make this one really quick story. So I had a beautiful woman come in that was, had been in a wheelchair for decades. And we had to transfer her from her wheelchair to our chair. It's just a matter of lifting her and setting her down here. And I don't wanna sound negative when I say this, but when I lifted her up the first time, she was soft, you know, fluffy, kind of, you know, 'cause she couldn't, she didn't have a lot of muscle tone and Lord knows, how could she? She spent her life in this wheelchair. So I, it didn't surprise me. I would put her in the wheelchair or we put her in the machine. [00:24:19] Lindsey, I will say probably in three months, maybe, when I would reach over to help her, instead of reaching around somebody that was fluffy, I was reaching around somebody that felt like a granite statue. She was solid rock, and I saw that happen and I saw what that did for her life. She could get in and on and off the commode on her own now. She could get in outta the car. These things that make a difference with independence, these things that are so important that we take for granted. [00:24:49] Lindsey Dinneen: Yeah. [00:24:49] Dr. Scott Bertrand: I saw these incredible recoveries and I knew then that I was absolutely on the right path. It wasn't about our six packs and our low back pain. It was about these people that had been almost forgotten and deserved so much, and now they're having an opportunity with hope and getting some great results. So that's the reward of MedTech. That's why, and all your listeners, hang on. It's worth hanging on. It's taken me three decades. I mean, you can't expect to go out and be tampering with people's lives and not expect it to take a long time to get there. People aren't just gonna let you start messing with them until you can prove you're doing the right thing. But it's so, but don't give up. Do the research, keep doing it. And that one person that you help, maybe you'll be a million. [00:25:33] Lindsey Dinneen: Yeah. [00:25:34] Dr. Scott Bertrand: I know that's what's gonna be happening to us. [00:25:37] Lindsey Dinneen: Yeah. Oh, yes. And thank you for that encouragement because I, like you said, it's a long road. So it's helpful to have people on the other side of it going, "Yes, it's possible. It's absolutely it. It'll take time, but you can do it." yeah. So, looking back ?Over your life, I'm just always curious about this, you know, do you think, is there any way that six year old Scott could have possibly had an inkling of what was to come in the future? What your path may have turned out to be? [00:26:09] Dr. Scott Bertrand: I, you know what's funny? I'm so that, that's such an interesting question. I'm writing a book and the book is, you know, it kind of goes through some of my life and I was just doing this the other day and, yeah, there was a six year old Scott that had an occurrence that happened to him that made him stop and think and go, "my God, I'm driving a miracle." and I was only six. And I remember it like it was yesterday, and it stuck with me. Long story short I was, I shouldn't probably be alive, but due to just natural reflexes, I got outta the way of something. And what I had to say, and I realized is I moved on from that potential horrible trauma that my body moved me out of the way. [00:26:50] Scott didn't, little six year old Scott wasn't smart enough. My body pulled me outta the way. And that reflexive action, that right there is what the AllCore relies on. So I don't know if that was the very first little thing, the very, you know, the little spark that said, Hey this machine you're driving is not just a bucket of bolts. You know, this is pretty impressive. And I got to, I still get to see that miracle every day. It's amazing. [00:27:17] Lindsey Dinneen: Yeah. Yes, it is amazing. Yeah, thank you for sharing that story. That's pretty, pretty interesting how that ended up being a, you know, of course, like, like you said, six year old Scott wouldn't have known where that would've led, but hey, It's, it's just, it's cool to see those threads looking back. [00:27:35] Dr. Scott Bertrand: Yeah. That's what they're the little seeds that found some fertile ground somewhere down the road that'll let 'em grow. But they, it's all those little things. And I can go through my life and point out about a dozen of those and that. You know, you go through life with all kinds of paths that present themselves, and you right or left. And where you are today is dependent on all those choices you made. But I can go back and look at so many of those and go, "thank God I turned that way because that allowed me to get here." And [00:28:05] Lindsey Dinneen: Yeah. [00:28:06] Dr. Scott Bertrand: That's almost pure luck. I don't know. So, [00:28:09] Lindsey Dinneen: Or Destiny or both? [00:28:12] Dr. Scott Bertrand: You know, I prefer to say that too. I think we're all put on this world for a reason. I think one of the things I say to people all the time, and the two biggest moments or greatest things in your life is the day you were born and the day you realize why you were born. And that, I realized that day, when it finally came to my mind why I was here that my job on this planet was to make sure that people knew that there was an alternative, and just make sure it happened before I died. You know, I just I remember one time sitting on a couch and all of a sudden realizing that if I don't do this, it might not get done. That was a frightening place, it really, it scared me. I was kind of thinking in my mind that someone else will come up with it, and I was okay if somebody else did. I just knew it needed to happen, but all of a sudden I realized maybe somebody else isn't going to, and I knew it was my job, so. [00:29:09] Lindsey Dinneen: Yeah. Yeah, that, that brings up an interesting point. I mean, my initial thought was that quote from Spider-Man where there's the whole " with great power comes to great responsibility." And, you know, and it's not exactly applicable here, but the idea of when you've been presented with a series of challenges that have led you to a possible solution. Yes, I think there is some sort of feeling of I have this responsibility to, to help because this isn't just about me anymore. This is about the planet. Who else could I impact if I can bring this successfully? And there are, and that's probably something really helpful because, I'm sure as a founder and you know, and you're leading your company, there are days where it's tough and you have to go back to your why of, you know, why are we here? Why are we, you know, going to all this effort and expense and whatnot. [00:30:12] Dr. Scott Bertrand: Right, right, right. You know? Yeah, exactly. It's every company, and I think a lot of people have, we all have dreams, you know, we have dreams, we wanna do this and do that, and dreams and goals, and those things and they all drive us forward, and they're good motivation. But when it goes to a mission, when it goes from a dream to a mission, it's a total different thing. It's a mission is one of those things that you think about it when you go to sleep, but it wakes you up in the morning and starts beating you on the back until you go ahead and get it done. I was almost fearful of if I didn't do it, God was gonna throw me off another roof and break something else. I needed to get this done. [00:30:50] Lindsey Dinneen: Oh no. [00:30:51] Dr. Scott Bertrand: Hit me twice. He told me what to do. He's like, pay attention here, gotta get this together. So, but anyway, I did. It took me a little while, but you hit me in the head a few times. I'll wake up . so, we did, and here we are. [00:31:06] Lindsey Dinneen: I love your honesty. That's fantastic. In the end, you followed that calling or leading or whatever you wanna call it. So go. This is so much fun just to hear all of your stories and whatnot, but I wanna pivot and take it in a slightly different direction completely for fun. If you were given the opportunity to teach a masterclass on anything that you want, it can be within your industry, but it doesn't have to be. You get paid a million dollars for this. What would you choose to teach and why? [00:31:40] Dr. Scott Bertrand: I'd listened to the offer. What I've learned, and I could probably share better than most things would be, how important perseverance is at the end of the day. It's the ability to focus and not give up. It's that day to day responsibilities that lead to the final goal. It's, I just know, like I said before, it's not going to be easy. So if you want something easy, you need to pick something else. I would think I would just explain to people not only how to persevere, and by that I mean sticking to a recipe, maintain your vision and your passion because you are the one who has to protect that vision. And then do everything you can again, I guess, to make it happen. But that it's, you just don't give up. No one said it'd be easy and, you know, you gotta do it again tomorrow. But it's there. It's there. It's there. There is a ladder and the rungs are hard, but one step up is one more than yesterday, and I'll take that. [00:32:40] Lindsey Dinneen: Yeah. That sounds like a fantastic masterclass. So yes. How would you like to be remembered after you leave this world? [00:32:48] Dr. Scott Bertrand: You know, this is a powerful thing that we're doing here with the AllCore360 and to possibly able to be the inventor of a device that can really impact millions upon millions of lives. I don't think there's any legacy anybody could ever ask for that could be greater than that, but I think what's every bit is important and I think in medtech and all these innovative companies, I really know that-- it took me a while to realize this-- but you can't do big projects alone. You can't take on gigantic projects of changing the world by yourself. So you really need to develop a really good team. And I took a little too long to develop that good team. But the legacy I would like to leave, not just for the device and my name, this group took on that mission of changing lives just like I did. And they've invested their energy just like I did. So my legacy needs to include their legacy. They need to be just as proud of changing the world 'cause they have, and I could not have done it without the help. So it's that it's all of us, you know, it's that legacy. You know, two generations from now, their granddaughter needs to say, "daddy, you worked on that, didn't you?" "Yes, I did." And I want them to have that pride. I really do. That'd be a great legacy. I could wouldn't ask for more than that, you know. [00:34:16] Lindsey Dinneen: Yeah. Yeah. That is a great legacy. Absolutely. And final question, what is one thing that makes you smile every time you see or think about it? [00:34:28] Dr. Scott Bertrand: Gosh, there's several of those. You obviously can go to the birth of children and grandchildren. Those are hard to beat, but I, in, in, if not down that line. Yeah. Yeah. I'm a, I'll tell you a really quick story that, and I'll try not make it too long, but it was one of these individuals that had been in a wheelchair and were working with me on the device. And like I said, these things are always so rewarding and I love them so dearly, and I have many memories, but one that I will always smile. The girl's name was Lori, and like I said, I love Lori. [00:34:59] But so, you know, it's hard to explain, but the device is a, it's a challenging device, and so, I could put it at a certain angle and it would be more difficult than maybe the angle you did got on. So we could compete, you know, I could do more than you, or you could do more than me. So I was using the device, obviously myself, and so I had a certain range that I went to that I was proud of. In fact, I, you know, I'm pretty tough. I'm down here. I'm doing a really good job. Here comes this gal on the wheelchair, by the way, the gal I'm talking about that turned into a granite statue. It's that gal. But so we start out, and I am way ahead of her, you know, and I am, I'm way ahead of her. Of course I am. But then like a two weeks later, she's gaining on me and three weeks later she's gaining on me and six weeks later she's on my rear end and I'm going, oh my gosh. I finally had, I stopped one day and I just had to look at her and I said, "Lori, How in the world are you doing this?" Because you know, I knew where I was at and she took her finger and put it in my face and went, "how are you not?" [00:36:07] And I will never quit smiling on that day because she struck me to the ground and basically said, "here I am sitting in a wheelchair and I'm kicking your rear end. What is your excuse?" I mean, she brought me to my knees and I will never forget that. And I'll smile because that showed me power that I've never seen. And I only pray I can be as motivated as she is someday, you know? But I will always smile. It was a wonderful day. [00:36:36] Lindsey Dinneen: That is incredible. I love that story and I also love the fact that that makes you smile that sort of Very much, you know, confrontation. And this is, she's gonna speak her truth to you. And you know, you took that as a good thing, as a challenge to keep, you know, doing what more of what you can do. And I, [00:36:56] Dr. Scott Bertrand: She was right. Yeah, she was right. She hit me right where I live and I thought, you know, I don't think there've been many people on the planet that would even do that or even try that, you know? Yeah. It was came right at me. [00:37:10] Lindsey Dinneen: I, love her boldness. [00:37:11] Dr. Scott Bertrand: Love her dearly for it. [00:37:12] Lindsey Dinneen: That's fantastic. Oh my goodness, this has been so much fun. You are incredibly inspiring. I love hearing what you're doing to really make a difference. I'm so thankful it has made a huge difference for you personally. But then, like you said, all of the ripple effects and all the lives you're touching, I think it's absolutely incredible. So I just wanna really, you know, basically say thank you. Thank you for the way that you are choosing to lead your life, and thanks for joining us today. [00:37:43] Dr. Scott Bertrand: No, that's I really appreciate it and I hope in the time we spent, I could leave your listeners with maybe there is some hope for some of the people that mo so many people I know, people have had a stroke or in a wheelchair and loved ones that could, there's, I just want them to know that, hey, reach out, look around. We're growing as fast as I can grow it, but there may be one close by and I would like to at least try because it's for some, it's remarkable and I appreciate you giving the opportunity to share that. [00:38:09] Lindsey Dinneen: Yeah. Yes, of course. We are also so honored to be making a donation on your behalf as a thank you for your time today to Sleep in Heavenly Peace, which is an organization that provides beds for children who don't have any in the United States. And so just thank you for choosing that one in particular to support, and we just wish you continued success as you work to change lives for a better world. [00:38:35] Dr. Scott Bertrand: Lindsey, I so much wish that and to you. I've enjoyed your podcast. I know you're gonna do wonderfully well as you do more and more. Keep me in the loop and I'll look forward to talking with you next time. [00:38:45] Lindsey Dinneen: Sounds great and thank you also to our listeners for tuning in and if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two, and we will catch you next time. [00:38:59] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Marina Daineko, a biocompatibility expert with a background in analytical chemistry, shares her journey from a research assistant in physical chemical problems to a prominent figure in the medtech industry. Marina discusses her passion for understanding the regulatory compliance and quality management systems in medical devices, reflecting on her curiosity and desire to make a difference in people's lives. She also shares her commitment to increasing women's representation in the medtech field. Guest links: https://www.linkedin.com/in/marinadaineko | https://www.intrinsicmedicalgroup.com Charity supported: ASPCA Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 023 - Marina Daineko [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. [00:00:52] Hello, and welcome to The Leading Difference podcast. I'm your host, Lindsey, and I'm excited to introduce you to my guest today, Marina Daineko. Marina, a certified biocompatibility subject matter expert with an MSc in analytical chemistry, shines as a dynamic figure at the intersection of medtech and chemistry. Her knack for seamlessly bridging biocompatibility, regulatory compliance and materials science, sets her apart. Marina's captivating presentations at conferences, including the prestigious Women in Tech Global Conference 2023, underscores her multifaceted expertise in the medtech industry. [00:01:31] Welcome. Thank you so much for joining us. I'm so excited to have you here today. [00:01:36] Marina Daineko: Hello, Lindsey. Nice to meet you. Thank you very much. [00:01:40] Lindsey Dinneen: Yes, absolutely. I was wondering if we could start off by you just sharing a little bit about your background and yourself and how you got into the medtech industry. [00:01:51] Marina Daineko: Oh, yeah, absolutely. Actually, it's very interesting story because I have started with medical device industry, not from the very beginning. But since I was young, I have always had a keen interest in learning more about the properties and different forms of matters and understanding how this undergo changes. So all in all, I fell in love with chemistry while I was in high school, and knew that I need to proceed with chemistry in my adult life. So anything that can be touched, tasted, smelled, seen, or felt is made of chemicals. And I was inspired by this fact and yeah, so I decided to connect my life with it. [00:02:36] And it's interesting because I started my career as a research assistant in the Research Institute for Physical Chemical Problems. And here I had a really scientific background because I published several articles, put my hands into patent work, and so on and so forth. And everything related to non resist photocatalytic lithography and nanoelectronics. So far away from medtech industry. And yeah, but it was interesting for me. And it was sometime after that it was time of self discovery through challenges, because I wanted to do something in my career that is challenging, interesting, and makes a difference in people's lives on a daily basis. [00:03:23] And actually around this time, I found out that my ancestor, Vladimir Galalyev, was a researcher in medicine and published academic papers dedicated to rheumatism and the morphology of allergy. So, I found it interesting and I decided that I might delve into this area, into this domain. So all in all, I started look for opportunities and found out RNC position. And that's why I joined MedTech industry as R&D and my background in chemistry and material of science helped me a lot here. And I'm a curious person, so when I was working as R&D, I also was trying to understand, "Okay, what are the sources of different requirements?" What are these come from, what are all these regulations that some people are talking from time to time. [00:04:20] And as a result, yeah, that was really interesting for me. Okay, I need to understand the source. I need to understand the matter, what I'm doing, why I'm doing. So, and as a result, I started to look into regulatory compliance area and overall, like, quality management system, just understand how the things work and to understand medical devices from different areas, right? Because it can have very different requirements depending on what aspect you're looking from, right? [00:04:51] So I was really fascinated and thankfully I had the chance to, to join biocompatibility and biological evaluation team as R&D also understands the requirements with chemical background in chemistry. So I started to look into biological evaluation to, because it's so interesting for me, look here, it's mixture of science, also medical device, and additionally some investigation, some topics that are not discovered or something like this. So it's really nice. And also next step I decided, okay, I'm pretty aware like what are things with medical devices that contain hardware for instance, but how make this medical device life. Because it's really interesting and fascinating to see how their lives can be changed. [00:05:45] So that's bring me to software in the medical devices. So software and firmware is something that could help to make medical devices live so they can be used in some analysis, predictions, and so on and so forth. And that's why I'm here in the medical device industry, really enjoying what I'm doing and understanding the medical device from different perspectives. [00:06:10] Lindsey Dinneen: Yeah, that's wonderful. Thank you so much for sharing your background too. It's so fun for me to hear about how you go from so many different, yeah, because you're so multi talented, and you're so interested in so many things, and I love hearing that. I love hearing about your background in chemistry and then you went into R&D and now you're doing software and firmware. Oh my goodness, you are a lifelong learner! [00:06:38] Marina Daineko: Yeah, I believe it's very important because we are living in book of world. It means that, there are a lot of changes around us. And additionally, for me, it's really interesting. I'm really fascinated to see is a medical device from different sites. Okay, we have compliance. Compliance means like this requirements, right? We have R&D and product quality and biological relations and those requirements may be applied, and when touching one topic, it's very interesting to see what is beyond this topic. For instance, as I said, okay, R&D requirements, design input, design verification activities, and so on, according to, for instance, ISO 13485 or CFR part 820. But what about regulatory, right? What about FERS? [00:07:27] Moreover, it's also, yeah, one thing that I'm proud right now is that this year I took a very bold choice to become a student one more time and I selected a program that focused on the medical sterilization engineer. So I believe it helps me to understand medical device even deeper because biocompatibility and sterilization are things that lay near each other. So just to deep my knowledge in the sterilization and disinfection areas, I picked this program. So I'm a student again. It's a very nice feeling. [00:08:09] Lindsey Dinneen: Oh good, yeah. I love how you said that, it's a nice feeling. [00:08:15] Marina Daineko: Like back to school, yeah! [00:08:17] Lindsey Dinneen: Yes, that is ,incredible though and it is so Interesting to hear how you just keep developing your skills, and like you said, you're a curious person, so you're going continue to explore different ways and help the industry move forward. So, good for you. [00:08:35] Marina Daineko: New choices for industry, [00:08:36] Lindsey Dinneen: Nice. Nice. Okay. So, I know that you also are an advocate for women in medtech, and I would love if you would share a little bit more about that and your involvement. How did all that get started, and what are you optimistic about with that? [00:08:56] Marina Daineko: Oh yeah, it's great questions. Thank you very much for asking it. So it has started actually recently when I was invited to speak at Women in Tech conference. So I was really excited here because in my experience, I-- all right, some time ago, long, long time ago, I don't remember even how many years it was-- I tried to start a business as a woman and unfortunately, I have got quite a lot of pushbacks with said words, like for instance, "okay, you need to sit down at home and growing up children and I don't know, cooking," and for me it was like a question, "okay, I can do it truly, but I have like other perspective and other ambitions and willing motivation to grow like a professional, like an expert." So for me it's very important to show an example for other people, women said, "okay, we can, surely we can grow up children. Surely we can take care of some other people and cooking and cleaning, like this man." [00:10:09] So it's very important to show an example that I can do it. So everyone can do it. Everyone has own voice and this voice shall be heard. It's very important. So it started quite innocent for me, just invitation to, to talk at the conference, but I was so proud of it. And I shared this news with my colleagues, with my family, friends like with everyone, I believe, and trying to support this. [00:10:39] Moreover, recently I has been nominated for Women in Tech nomination. So, and I'm so excited of it because my presentation, I was talking about Internet of Medical Things actually, and compliance and risk aspects within IoMT. So, my, my talk as a speaker and I was congratulated with this nomination, so I'm so proud to, to show again other people that, "okay, look it start, it has started really innocently, but where I am now." [00:11:13] I'm nominated and I am growing awareness regarding women in tech and asking for collaboration here as a women to join this network because I could see a lot of opportunities with it like to support each other, to help each other to grow together, because when we are sharing our expertise, when we are given advices, when we are providing areas for improvements, it is really also very important, actually, our points of growth here. So I believe it's very valuable network and really could see a lot of improvements while taking part in this Women Tech Network. [00:11:54] Lindsey Dinneen: That's incredible. And first of all, congratulations on that nomination! [00:11:59] Marina Daineko: Thank you. Thank you so much. [00:12:01] Lindsey Dinneen: That's incredible. Yeah, I'm so excited to see where that leads, but in general, I [00:12:06] Marina Daineko: Yeah. [00:12:08] Lindsey Dinneen: Yeah! And you're like, oh my goodness, "yes, me too!" Ha Yeah, but I just I love the fact that, it started off with an ask of you do this talk, and then you just said, "okay, and I'm diving into this too." So, [00:12:25] Marina Daineko: It's exactly how it works with me. [00:12:26] Lindsey Dinneen: Okay. Excellent. Yeah. And, I know from being connected with you on LinkedIn that you are very passionate about helping to spread knowledge about the industry. Yeah, and so you do this Mondays, you do like a coffee chat or coffee talk. Yeah. Can you tell us a little bit more about that? [00:12:50] Marina Daineko: Absolutely. So it's again interesting story because sometime ago, actually I have started to be pretty active on my LinkedIn, like just around the year or so. And how I, why I decided to be active and why, how it's actually started. It started because I felt like I'm so full of expertise, knowledge, advice that I can't just hold them with myself so I need to somehow to share them and I found LinkedIn platform very useful and comfortable for such knowledge sharing because here there is a community of different experts and that's why we can share opinions, advices, comments, because it's also valuable to see from some things from our perspective, right? [00:13:43] And on Mondays, I'm doing like Monday news. And I remember when I'm using actually my own picture. I took this picture when I had a coffee and croissant, like dreaming, "okay, what would I like to read on Mondays?" And for me, it was kind of a digest of important things. And I usually connect in this important available things around biological evaluation, because I could see quite a lot of information regarding compliance, quality management system, risk management clinical evaluation, like really ocean of news and updates and knowledge sharing regarding clinical evaluation. [00:14:24] But for some reasons, I saw that biological evaluation is kind of underestimated, meaning that-- and it's quite, it's not too easy to find some valuable information or clarify something or, to make it transparent and traceable why we need to go like this direction or this direction, and what are updates in the industry and so on so forth. And I know that quite a lot of people are too shy to ask directly or they simply don't know whom to ask, right? Because if you are known as a subject matter expert in this domain, nobody would ask you even if you are right. [00:15:03] So, and it helped me to understand like, okay, maybe I could put myself in this niche and provide some updates like I'm doing here on Mondays, like taking one topic and provide small basic, maybe basic, maybe not too basic things, around this topic. Like for instance, biological evolution, but inside of biological evolution, we have a lot of things to talk. And to be honest, I can talk about a biocompatibility like all days and nights. It can be unstoppable. So, yeah. [00:15:42] Lindsey Dinneen: Okay, so you have lots of things in the works and you're a student still. What is coming up for you? What is next that you're particularly excited about either personally or professionally or whatever you want to talk about. [00:15:55] Excellent [00:15:56] about [00:15:56] marina_1_10-18-2023_190318: My God, I swear a lot of things, to be honest. Yeah. First of all, maybe from professional side, I'm really excited to take part in the MedTech Summit. Flying to the United States, and I'm really excited because there would be a lot of professionals and subject matter experts within the summit like from biological evaluation, as well as regulatory affairs. So I'm very interested to make like connection in real life, not only like online, looking at people's heads and that's it. [00:16:34] Lindsey Dinneen: Right? [00:16:37] Marina Daineko: So, I'm really excited of it. Also I will have panel session about post market surveillance. And it's very interesting, actually, format because it would be different experts here at this panel, like from regulatory, clinical, risk management. And I will represent biological evaluation aspect. So, and we would be talking about post market surveillance for medical devices. It's also hot topic and I'm excited because in such format is it, that would be my first time in such format with other experts, but I find it really valuable because this cross functional team usually, it's like kind of brainstorming, negotiation, discussion. So I expect like a vivid discussion around this topic and again I believe that would be very interesting insights here during this panel. Yeah. [00:17:34] Lindsey Dinneen: Yeah. Yeah. And, speaking to that, when you are involved in these these panel discussions or conversations or things where you might, where like you said, you're going to be surrounded by experts and you have your area of expertise too and whatnot and you're sort of all collaborating, is there ever a moment where, does it ever feel overwhelming when you're just " oh, I don't know enough about this topic?" I'm just curious because I know sometimes we have those moments as humans. We go into this situation that's not 100 percent our realm, and I'm just curious how you handle those moments of " how can I contribute to this conversation?" [00:18:13] Marina Daineko: Yeah, that's a great question because I wouldn't be honest if I say that I don't have such moments. Surely I have and as I'm quite active as a speaker in different conferences. So surely I have such moments in my life. And yeah, so, how I deal, I'm trying to be logical, first of all, and structured. Actually, I'm a super structured person. I have folder and folder, all the reminders and so on. Organized and structured. But, yeah, so I'm trying to think in this way, "Okay, here is the question. How can I decompose it for the parts that I can understand, right?", And I can provide some feedback, insight or advice, for instance, right? Because usually a person who is asking a question, this person usually has some background or circumstances or conditions why this question is asked. So I'm trying to decompose this question if it's still unclear. So I'm trying, I'm asking to ask maybe in a different way. It gives me additional time to think actually, so well, right? [00:19:19] So, and in that for, I would say for 100% cases with this decomposition or, and for instance, asking to reward the question, I can answer it because it gives me time to think the decomposition can gives me the base, " okay, we are talking about XYZ or ABC or what we are talking about, right? What area from what perspective?" So all the things help me to answer, but usually, yeah decomposition and additional time to think helped me each time. [00:19:57] Lindsey Dinneen: Yeah, and thank you for your honesty, because I really love listening to other people's strategies, because I think we all have those moments sometimes, right? [00:20:04] Marina Daineko: Absolutely. It's very nice because I also can understand, okay, what are my weakness? What my, what are my areas for improvement? Maybe I need to dive deeper into this topic. But, I am, I consider myself brave enough to say, I don't know if I really don't know something, right? Not to, not to make a not proper conclusions, for instance, or advices and so on, so forth, because it's very important to, to say such things because we are talking about medical devices. Medical devices are used when people are in need some help. It might be even the question of life and death so it's very important to say if I don't know so I'm saying I don't know, please ask this I need additional time to investigate. So I need to so I need this additional time, right? [00:20:56] And also what is very important for me as again as a woman and as immigrant, right? Not to be shy, but to talk, to speak up because yeah, I can be, I am an expert. And I need to show my expertise to others because others, other people can, for instance, they just simply maybe not aware that I'm expert, right? So it's very important to speak up and to be brave here. [00:21:26] Lindsey Dinneen: Yes, a hundred percent. And I kept thinking about that when you've been telling us about your life and your trajectory and how curious you are. And I was going to say that bravery is such a strong theme. I, it really is though, because it is hard sometimes to be willing to speak up and say, "I don't know, or I let me go back and research or whatever." And so I really, I think that's really powerful what you said, and I appreciate your candor there. And I'm, I am also curious myself, so if, let's say that you are in a sort of mentorship position. What kind of advice would you give somebody, maybe especially a woman or, somebody who is coming from a different background who may not have the same access basically, how would you advise that person to participate and to keep moving forward with their own career, even if they're feeling a little uncertain or they don't fit in. [00:22:30] Marina Daineko: Oh, yeah. No, I love this question. Thank you for asking it. So, I believe that we are living in such a world where hard skills shall be complemented with soft skills. And as far as I could see, listening is very important. Listening and communicating properly. And listening, I believe that listening to others is a part of communication. So, regarding listening, it's very important to listen,: like kind of correctly what I mean on this is for instance, not multitasking when someone is listening to another person, right? Because sometimes we are doing something and listening not attentively. And we, for instance, can mix up topics or don't understand something or just don't miss some part of, conversation. And that's why it's very important to, to listen attentively, really deep really diving into the topic and understanding what is going to be, like, what we are talking about, what is the topic, what is the ask. Maybe something is hidden between rows, so it's very important. [00:23:44] Sometimes we are listening with a goal in mind. What it means? We have we are talking to each other, right? But I have my goal in, into my mind, so it doesn't matter actually what you are talking about. So. I have something and that's it. I don't care. So it doesn't work. It doesn't work actually. So especially for leadership, but not only for leadership, it's just for, for real life. It doesn't work. We need to listen and trying to understand what another person is trying to say here. [00:24:20] And one more, maybe things that I noticed is judging. So when something, when someone is saying something, so we are judging. We are like, okay, there is just black and white and that's it. But fortunately, no, we have different colors, so like rainbow colors, there is no black and white, so we don't, we should, we shall not judge, we need to listen attentively, accurately, and trying to get rid of maybe some negativity when talking to a person, so it's very important because collaborating with different people may be challenging, especially in these cross functional teams because I could see more and more that we are working in remote world. [00:25:08] So I'm from Poland, you're from the United States. Someone is from the United Kingdom, someone from Australia and it's really amazing and I love it. But people are from different cultures. People have different, I don't know, mood, time zones, different things in their private life. So it's very important to switch off this as, as much as possible, this emotional thing and don't judge, just take the information as it is. And actually it helps me also a lot when I'm doing internal audits. So as it's written, I could see, and I could just, yeah, ask for some evidence as it's written not judging here. [00:25:50] And maybe one more topic here I would like to raise, it's about preparing your response. So when, for instance, my colleague is talking to me and I just codes the first sentence, for instance, right? And I'm answering to this sentence, not to whole speech or whole things that this person is trying to say, but to this sentence . Please don't prepare your response and improve your listening skills. I believe that this listening skills, first of all, when we are collaborating with other colleagues from other, I don't know, departments, for instance, like product quality or clinical affairs, regulatory affairs, R&D manufacturing, so it's very good, marketing, some other. So it's very important to listen and to listen to the messages because there are a lot of valuable information. It shall be filtered accordingly and taken into account for, taken for consideration. [00:26:51] And when we have like good listening skills, we can proceed with improving our communication because I believe that communication is just powerful tools that can resolve any, simply any issue, challenge, whatever, if we can communicate effectively so it helps. It helps a lot in professional life, in not only professional , so it's very important to work on this. [00:27:17] But coming back to your question, I believe that any person can entry medical device industry because there are a lot of directions here. This directions depends on people background. So here we need like mechanical engineers to be able to prepare drawings and actually work on new product development or modifications of existing medical devices, for instance, right? Someone with a chemistry, biology background needed for like specific things like biological evaluation, clinical evaluation, right? [00:27:49] But even people without technical background, someone who is like a good communicator is very nice. It's very valuable person in the project because such person can help with communication between different departments, because someone needs to orchestrate all this work for medical device. So don't be afraid, listen carefully, and improve your communication skill. And I believe, yeah, it would help in any industry, including medical devices. [00:28:21] Lindsey Dinneen: Yes, that's great advice and thank you for sharing that. I think you're right that in many aspects, so one of them, [00:28:29] Marina Daineko: Thank [00:28:30] Lindsey Dinneen: I just want to clarify, agree with you, one thing that stood out to me is, you said that it, It is definitely possible for people to come into the medical device industry. And I think you're absolutely right. There are lots of avenues within the industry. So if your background is in engineering, there's plenty of places for you to go, but if your background is in marketing and sales, I mean, people have to know your device exists in purchase it. So all of the roles are are useful. So I think you're absolutely right in finding the area where you fit in. But the industry is really friendly, is what I have, yeah. [00:29:12] Marina Daineko: Absolutely. Because if I can, yeah, add here, for instance, for marketing and sales, so, I love these people because they help me a lot. Why? Because I am doing, for instance, biological evaluation, I need, this is my documentation, I need to explain other people from notified bodies who, for instance,. Can audit this documentation how this medical device works. And what happened here? Look, I need these people from notified bodies or like from like auditors, right? They can have really different background. They can have background in clinical or they may not have this background. They may just have, I don't know, absolutely different background, right? They are not familiar with this specific medical device. [00:30:01] So, and within my biological evolution, I need to explain how this medical device works. And it's known fact that a lot of people can consume the information with their eyes. So it's visual. So it means that the information shall be visualized, and visualization is the best tool to explain some things to people. That's why I love marketing, people from marketing and sales, because they can prepare these great pictures of medical device, how it works, for instance, on YouTube, like video or whatever, right? As well as, yeah, to make it understandable for everyone. It's simple, not with all these tons of words. But usually it, it shall be described as well, right? But visualization as well. So, that's why, yeah, I triggered so much when you mentioned marketing and sales, because yeah, it's really important to explain complex things in pictures. [00:31:02] Lindsey Dinneen: Yes. Indeed. Yes. And I'm glad to have an advocate for that. [00:31:12] Marina Daineko: Absolutely. Yeah. Yeah. [00:31:13] Lindsey Dinneen: Yeah, absolutely. Pivoting the conversation just a little for fun. Imagine you were to be offered a chance to teach a masterclass on any subject that you want to. You would be paid a million dollars to do so. It can be about your industry, but it doesn't have to be. What would you choose to teach and why? [00:31:35] Marina Daineko: As I said, I can talk days and nights about biological evaluation. So maybe it would be the simplest answer because it really, it really works for me. I mean, like I can talk about biocompatibility a lot and I am more than happy to share some insight with people, especially taking into account that this buzz and noise regarding biological evaluation recently, and I could see a lot of people that are coming in this aspect, this domain, I mean, in biological evaluation in medical devices, so I would be more than happy even be paid properly for this. [00:32:18] Lindsey Dinneen: There you go. [00:32:20] Marina Daineko: Yeah. [00:32:22] Lindsey Dinneen: You could put the million dollars to, your research or something fun, so. [00:32:27] Marina Daineko: Yeah. No, absolutely. When I was younger, I had actually a dream to organize a kind of, research center and to have some equipment, to have some databases, and so on for scientists who can, for instance, like scientists, startups, and so on so forth who can actually try, say, ideas on this on this research center. So if you, for instance, I don't know, invented something, you can go to my research center and I, we can first of all, test it and also provide like scientific background if required to help with patents and so on and so forth. So I believe this million dollars can be used for this goal. [00:33:12] Lindsey Dinneen: Ooh, I like it. Okay. Excellent. All right. And how do you wish to be remembered after you leave this world? [00:33:24] Marina Daineko: This is important question and I'm thinking from time to time exactly on it. So, it's very personal for me because it's also a funny story. When I was a student at the university, I was, I have been providing kind of mentorship for people who would like to study chemistry. So, and usually I was working with, mentorship, blaming the fire for chemistry. So showing that chemistry is not just something boring, boring science, but also very interesting and it can be kind of fun. So, I had a case when one boy he needed he needed improve his knowledge for chemistry just for his marks because he intended to, to get in British College. And, we were having the studies with him. I was explaining things and providing real life examples where and how chemistry can be utilized and improved. And in the end, this boy decided to utilize chemistry in his life, so he switched from math as well as physics to chemistry and connected his life with chemistry. [00:34:40] And for me, it was like, "Oh my God, it seems like I changed someone's life." And it was so, so inspiring for me that I decided for myself that I would like to proceed with it, that I like how I can make this connection to show people the beauty of different things, like for instance chemistry to this boy. And yeah, I believe that I'm pretty successful in such things, so I would say that I would like to be remembered as a person who can connect people with beautiful and inspiring things, changing lives in this matter. [00:35:26] Lindsey Dinneen: Ooh, that is a beautiful goal. I love it. That just gave me chills. [00:35:33] you [00:35:34] Marina Daineko: Yeah, no, I feel the same, actually, because for me, this boy, it was like a changing moment for me. Yeah, it's very powerful. Even this even this memory is very powerful for me. [00:35:47] Lindsey Dinneen: Yes. Thank you for sharing that story. It's a fantastic story, and I love that because it's so, that just speaks to you and your willingness to, to help somebody understand something that doesn't come naturally or maybe easily to them. And what a difference you made in that person's life, so, yes, I think that's incredible and a beautiful life goal of yours. [00:36:11] Marina Daineko: Thank Thank you, Lindsey. Oh yeah. To explain like complex things into simple, understandable steps is my favorite entertainment, I would say [00:36:21] Lindsey Dinneen: Ah, okay, I love it, alright. What is one thing that makes you smile every time you see or think about it? [00:36:32] Marina Daineko: Oh, I believe it's my dog. I have pitbull, but she reminds me a cat, mostly, because, yeah, no, really, because, for instance, when I have a door opened to join other room, to go into other room, for instance, but when I close the door she needs to come back immediately. And it makes me smile because it's behavior of a cat and also yeah she's sleeping and she is snoring from time to time and when I have a meeting for instance with my colleagues So I am asked all the time "Marina, please don't sleep." Yeah. So, yeah it's funny and I adore her. I am working with her, actually, I like, I love walking like 10 kilometers or so. She's not happy with this distance, but she has just simply no choice with it. Yeah. So, yeah, no, believe useful for her heart, so that's my, yeah. [00:37:35] Lindsey Dinneen: Mutually beneficial for both of you. [00:37:37] Marina Daineko: Yeah. [00:37:38] Lindsey Dinneen: Yeah. Very good. Oh my goodness. That's fantastic. Yeah. This has been so much fun. Thank you so very much for joining us today. I'm just so thrilled to have you and you're so inspirational. So thank you for doing what you're doing and how you're continuing to learn and evolve with the industry, but evolve your own skills too. Yeah. And we're, [00:38:05] Marina Daineko: Thank you. [00:38:06] Lindsey Dinneen: Of course. And we're so honored to be making a donation on your behalf as a thank you for your time today to the American Society for the Prevention of Cruelty to Animals, which is dedicated to preventing animal cruelty in the United States. So thank you for choosing that organization to ,support and we just wish you continued success as you work to change lives for a better world. [00:38:30] Marina Daineko: Thank you. Thank you so much, Lindsey. It was a pleasure. I really enjoyed our conversation, a lot of, love and insight. So thank you very much for invitation and yeah I'm really happy to meet you. [00:38:45] Lindsey Dinneen: You too. And thank you also so much to our listeners for tuning in. And if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two, and we will catch you next time. [00:38:58] [00:38:59] Ben Trombold: The leading difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Today, we chat with Dan Purvis, CEO & Founder at Velentium, a Technology Expert  and Entrepreneur who designs and develops Medical Devices. Dan is also the Author of "28 Days to Save The World". About the book: In 2020, engineering firm Velentium faced an unprecedented ask: partner with a small medical device company and a very large vehicle manufacturer to increase emergency ventilator production from hundreds per month to thousands per week—in just 28 days.    https://benbellabooks.com/shop/28-days-to-save-the-world/

In this episode, Ken Hoyme, a semi-retired product security expert, talks in-depth about his 40-year career focusing on safety-critical systems, which spanned across commercial aviation, aerospace, and medical devices, with a particular focus on medical device security. Ken reflects on the personal impact of his work, and also talks about his continued involvement in the field through consulting, teaching, and volunteering post-retirement. He also discusses troubleshooting solutions, his pride for his family, and his passion for pipe organs. Guest links: https://www.linkedin.com/in/kenhoyme/ Charity supported: Save the Children Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 022 - Ken Hoyme [00:00:00] Lindsey Dinneen: [00:00:01] Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:08] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:13] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:27] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:37] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:41] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. [00:00:47] Hello and welcome to The Leading Difference podcast. I'm your host, Lindsey, and I am excited to introduce you to my guest today, Ken Hoyme. Ken is the semi retired former Director of Product security at Boston Scientific. His 40 year career spanned commercial aviation and aerospace and medical devices with specific emphasis on medical device security. In retirement, Ken continues to consult, teach, and volunteer. Welcome, Ken. Thank you so much for joining us today. I'm so excited that you're here. [00:01:20] Ken Hoyme: Thanks, Lindsey I'm happy to be here. [00:01:22] Lindsey Dinneen: Wonderful. If you wouldn't mind just starting off by telling us a little bit about yourself and your background, I would love to hear more about you. [00:01:31] Ken Hoyme: Sure, I'd be happy to. Being semi retired, I have had a career that spans close to 40 years, or actually I think I just passed 40 years about a month ago from when I started working. So I went to grad school, did four years of grad school at the same time my wife was in vet school, so four years of marriage that we were both studying like crazy. I never finished my dissertation on a PhD, so I'm the classic PhD, ADD person. Pretty much my entire career has been spent in safety critical, life critical systems, which has been a fascinating area. You gotta do the right job or people might die. [00:02:08] I started, split 50 /50. My first 18 years was at Honeywell Corporate Research Labs, where I ended up working on various things between integrated circuit projects, but a lot of it was focused on control systems for commercial aircraft, and so building safety critical systems that made the pilot interface to the airplane was fascinating, tough, but interesting problems. [00:02:32] Touched a bit on industrial controls and automotive controls, and then mid career, I got recruited away by former Honeywell folks who had gone to Guidant, medical device company at the time, that was later purchased by Boston Scientific, and where I ended up working initially on cardiac pacemakers and defibrillators and then shifted into remote patient monitoring, and that kind of evolved into more detailed interactions with how security can impact patient safety. [00:03:02] So a large fraction of the last 12, 15 years has been in medical device cybersecurity. Did a brief stint, three and a half years, at a small R&D company doing research on medical device cybersecurity, and then returned to Boston Scientific in 2016 to lead the product security program at Boston Scientific, which is what I was doing when I officially retired. [00:03:25] Lindsey Dinneen: Nice. Okay. So lots of cool twists and turns throughout your career. I wanted to touch on a couple things. The first is, you've actually talked about how one of the running themes was safety and safety critical systems and whatnot. And I'm curious, have you always had an interest or a passion in safety and security. Where did that come from? [00:03:49] Ken Hoyme: Given some of my behavior as a kid, you wouldn't think so. I certainly did my share of foolish things as you grew up. My, my interest in grad school was in computer architecture, kind of a foot between hardware and software, though I was in electrical engineering as a degree. So as I ended up at Honeywell, Honeywell was at that time focused on control systems. And control systems are cyber physical systems, they are computers touching the real world physically. And almost all aspects of cyber physical systems-- which are pervasive and now what's viewed as US critical infrastructure-- there's a safety aspect of whether you're talking about nuclear power plants or oil refining and things that can explode to commercial aviation, automotive. All of those things, if they don't work correctly, the people that are interacting with them that run the risk of being harmed. [00:04:44] So it really was that culture at the original research center of thinking about how you interact with the physical world. And so that really grew that interest. And that was the skill set in doing safety analysis that drew guidance to recruit me because it really was obviously another safety critical environment in cardiac devices. So it was a an early budding interest that was really nurtured by the projects and things that worked on for Honeywell. [00:05:14] Lindsey Dinneen: Yeah, absolutely. And then you obviously continued to grow in your career, you continue to be involved in safety and security. And then you had your stint at Boston Scientific. And I wonder if you could share a little bit more about some of the projects that you worked on that were particularly impactful or just moments that stand out perhaps. [00:05:36] Ken Hoyme: My first project, I knew nothing about things that bled. I had avoided them. In junior high, I had to dissect a frog, I really didn't like it. And so in high school, when you needed to have some science stuff, and I knew I was planning on going toward electrical engineering, I skipped biology and took chemistry and physics. And by working on cyber physical systems, aircraft and automotive and industrial controls, nothing bled, but I also had no pets growing up. [00:06:09] And when I started dating my now wife of 44 years, she had a quarter horse, 4 Shetland ponies, a dog and two cats at a 10 acre hobby farm she had talked her parents into buying so that she could have horses. And as a veterinarian, everything in her life bled, so we really had this difference in backgrounds, but interest in learning from each other. [00:06:35] And so when I first went to Guidant, the company recognized I didn't have that domain knowledge. And so I ended up being put on projects specifically with the goal of rapidly bringing me up to speed. I went to various classes on how the heart works, how you pace it, all the various different things. And I can tell you that the dinner conversation changed considerably as I was starting to learn these things and my wife knew these things. So it was kind of an exhilarating mid career change because of having to learn the domain. [00:07:05] So, because of my safety background, Guidant was working on a new architecture for their pacemakers and defibrillators. And I got put on the redundant safety core, which was a redundant hardware pacemaker and defibrillator. If anything failed in the rest of the device, the hardware would kick in and keep the patient pink. And so I got to work on that, and I ended up with several patents. [00:07:30] And so in 2006 or 7, I believe, my brother in law, my wife's brother, ended up with a viral cardiomyopathy and his ejection fraction was down at 15%. It's normally in a healthy human should be up around 70. He ended up getting a resynchronization defibrillator that I had worked on, as well as being put on the home patient monitor that I had been the lead system engineer in developing. And so that was that first family connection of recognizing that what you're doing is personal. [00:08:04] And a few years back, my now 95 year old mother in law has a pacemaker in her and I have four patents on the technology. So you're recognizing that people that you love and care for are using these things. And the people who get these things are loved and cared for by somebody, so it really becomes a passion of building something that works correctly and is safe. Those kind of things stand out in terms of things that are meaningful. [00:08:29] Lindsey Dinneen: Yeah, of course. Yeah, because when you are able to see the results in real time in real life, by people who you know personally who are affected by it, that's such a full circle moment of just recognizing that what you do isn't confined to this silo. It actually does impact lives. And that's a pretty cool thing to be a part of. [00:08:52] Ken Hoyme: And I crossed over into security. I can recommend the devices that I was involved in developing because I am personally familiar with the level of detail that had been done in terms of securing them. So I don't have fears that my family members or others are going to have hackers going after them, which is a paranoia in the industry. The idea of hacking pacemakers became, as Dr. Kevin said, " sucks the oxygen out of the room." It's theoretically possible, but very difficult to do, compared to devices that might be connected to a hospital network, which are exposed to more. [00:09:24] Lindsey Dinneen: And to that point, if you don't mind sharing a little bit more about how you were able to develop those skills and awareness of the importance of medical device security. I know that you are an expert in this field and there is a lot more education and knowledge these days, but it still seems like something every once in a while that you have to remind people, this is actually a critical thing. Do you mind speaking a bit to that? [00:09:52] Ken Hoyme: I started out as an electrical engineer, but evolved to a systems engineer, particularly working in aviation. I worked on the design of the flight deck of the Boeing 777. And Boeing is the-- at least they used to be, they've lost some of the secret sauce-- but they were the premier system engineering organization in the world. And working on a critical system for an aircraft with the master of system engineering, you start learning the techniques. So my, my evolution into system engineering was very much on the job training, certainly a lot of reading and things that went on at the same time, but it was also interacting with experts. [00:10:31] Similar thing happened when security came along is, I got recruited into Guident because of my safety skills. And then within the first year of being there, Guident was putting a remote patient management system together, which was a bedside monitor for every patient with the radio links to the device links up to a server that would analyze all the data for potential alerts that the physician should know. [00:10:56] The system has more than a million patients on it. So it's a scalable protected health information, all of that. Program Manager on that project understood the importance of the various ilities that sit around system engineering and deal with the development. So he hired in a PhD psychologist to do human centered design and machine interface, he had been dealing with all of those issues. And in the medical device world, user interfaces also touch safety, because if you have confusion and a physician or patient makes a mistake in using something, harm can happen. So it's another branch of safety. And he recognized the security implications of what we were doing and hired in security experts. [00:11:43] And so we had this old grizzled, bearded, absolutely canonical look of a computer geek that had been a chief architect at a company called Secure Computing and had been security. And he was titled our Security Curmudgeon and as Lead System Engineer, I worked with these various groups as we balance the design. And it really was interacting with real experts in this field who had no compunction about correcting me whenever I said anything that was inaccurate. [00:12:15] In that environment, I started absorbing. The methods of doing security and the importance of it and what those kind of, so it really was one of those cool opportunities in your career where you get to a Vulcan mind meld with experts and absorb the information and integrate it with what you know. [00:12:32] Lindsey Dinneen: Yeah, absolutely. And at the time of this recording the FDA has finalized their guidance and I'm curious to know what your thoughts are on that and how you feel it's going to affect everybody moving forward. [00:12:50] Ken Hoyme: It's interesting because both the original pre market guidance and the post market guidance came out relatively quickly. The time between the draft pre market and the issuance of it, I think was just less than a year, which everyone who were involved with guidance has said was light speed for the FDA. And the post market was similar, but they've done a couple of iterations in 2018 and 2022 of drafts. And, was in a meeting earlier today where two of the FDA people who had been working on that were mentioning that in both cases, they got more than 100, 000 comments back to the FDA related to it. [00:13:28] You know, the push by Congress to have it out by October 1st really pushed, I don't think anybody thought that it would be feasible to get it done. And yet they did it. It seems like they have clarified many of the concerns that were still in the 2022 draft, had some clear definitions about things like exploitability. So I think it really will anchor, and everyone is scrambling this week to read it and adapt to what's in there. But, the good news is it's not a giant leap from what they issued in 2022. So it's not going to have everyone doing a 90 or 180 degree turn on what they've already assumed it was heading for. So it's just good to have that out in its definitive form. [00:14:14] Lindsey Dinneen: Yeah, absolutely. And it'll be exciting to see how the industry adapts. [00:14:19] Ken Hoyme: As one example, the Health Sector Coordinating Council had published in 2018, I believe it was, their joint security plan, because the non formal standard, but kind of a guide, particularly helpful for smaller companies for what they need to do, incorporate cybersecurity into their quality system and their development. And a lot has changed, and so we have been working since middle of 2022, this is one of my retirement volunteer efforts that I'm involved in, to bring it up to date. [00:14:54] And there was a real goal for the JSB version 2 to be out by the end of this year. And we were worried about the race condition with the FDA getting their final set pre market guidance out. And so one of the activities now is adapting what we've written in the joint security plan to make sure that it is in sync and in line with the finalized guidance. By getting it out now, we have time over the next couple of months to make whatever changes we need to based on that change. Which will be good, it means when that guide is updated, it will not be anchored in an old guidance, but will properly reflect the new update from the FDA. So it's really great to see them do that. [00:15:38] Lindsey Dinneen: Yeah, absolutely. So circling back to something you mentioned, because I'm curious how you were able to overcome it. You mentioned you hadn't dealt early on in your career with anything blood related and you didn't necessarily want to go after that when you were in college. So how are you able to overcome that and say, "No, this is fine. I'm gonna, I'm gonna make it happen." [00:16:05] Ken Hoyme: Thankfully, I didn't have to personally do any implants. Okay. I didn't have to handle a knife or deal with that and get flashbacks of my frog experience. When I left Honeywell, I thought I was going to retire out of the company. I was in an absolutely great position at the research center. I was invited to the strategic planning sessions for the entire aviation business as a technical expert. Honeywell was bought by Allied Signal, which was quite a culture shift. They were far more prescriptive. You're telling research center, here's what you're going to do rather than asking you to partner with the businesses, determine how to best apply the skills. And the other aspect is because I had become an expert in commercial aviation, I was not learning at the rate that you used to. It's like, you know, a lot of things, you're doing more mentoring than individual personal learning. So when I shifted domains and got hired in because I was a senior fellow at Honeywell, they hired me in at the top technical rank that Guidant had at the time to be competitive. I felt a huge obligation to learn the domain as quick as possible. [00:17:19] I needed to feel like I was providing value. It's just not a good feeling to feel like you're taking a paycheck and not providing something for that. It's just not the way I was raised. And so I really took it on that I needed to learn this domain. And the reality, all kidding aside, is the work in understanding the physiology and the behavior of cardiac devices is really more about electrochemistry and how the muscles work and how arrhythmias occur and how they can be cleared. And so it was more of a learning a new technical domain than really dealing with the bleeding side of it. [00:17:57] Yes, when I was at Honeywell, we had a program where if we were working in the commercial aviation side, we had, it was pre 9/ 11, we had jump seat privileges. So I got to be in the jump seat of aircraft so that you could see how the pilots who use the systems you develop, how they interact with them, just as an experience base. And one of my cool things, just as an aside to talk about, along with the family members using cardiac devices is, I got to jump seat a 777 from Dulles to Frankfort, and that's the aircraft that I did a fundamental invention to enable how the flight deck works. So that was cool to actually see the pilots interact with what you did. [00:18:39] The same thing happened in the cardiac world is you got the opportunity to go and experience implants and see the doctors using and interacting with the devices. Again, part of that system's knowledge of how does the end person, the actual user, use those devices and how do you use that knowledge to get better. So the closest thing you get to bleeding is to watch somebody else do one but I never had to actually directly deal with blood. [00:19:10] Lindsey Dinneen: Okay. That's fair. That's a really good hybrid situation right there. Well, nowadays I understand that you are quote unquote retired, however, you are still quite active. So I would love to hear about your current initiatives and frankly, if you don't mind sharing, why you're still so involved, obviously you care, but I'd love to hear it from your perspective. [00:19:35] Ken Hoyme: So I've always been a bit of a workaholic. I gained a lot of my intellectual stimulation through the people I interact with. When I started a corperate research center, it was 25% PhDs, 50% master. It's a great learning environment because there were brilliant people are all around you. [00:19:52] One of my career advices I've given to the young people is go to a place where you are not the smartest person in the room, surround yourself with people you can learn from. Now you want to have your niche. You want to have something that you feel is your area of expertise that you build, but being or thinking you're the best person in the room isn't necessarily a good learning experience. So, I've always enjoyed interacting with people at various stages in their career. [00:20:20] So when I retired, I don't know how many different serious and semi serious reach outs I had from people asking what I was up to and what I was interested in. It was a dozen or something, but I had been interacting for several years at the company called MedCrypt out of San Diego, a company that focuses on initially tools to help secure medical devices, comes out of the medical device world and tools for software build of materials, things of that nature. And while I'm not a software engineer developing tools, they were also starting to build a service business to work with clients on how to improve their quality system. [00:20:59] When I was at Adventium Labs, that three and a half year stint I did between my two Boston Scientific experiences, along with doing government funded research on medical device security, I also did consulting with companies, and so I had formed a reasonably strong opinion about how you can best organize cybersecurity into a quality management system in a medical device company. And so being able to apply those skills, very lightweight, I've tried to keep my consulting to no more than one day a week so that I still can do some retirement activities. [00:21:36] And Mike Kijewski, who's the CEO of that, I've interacted with him for many years and he had been pursuing me before I retired. So they have some people on staff, two of them are ex FDA. One of their FDA people, Seth Carmody, had written the post market cybersecurity for the FDA and I think he did the first draft of the updated cybersecurity pre market. And then they have another gentleman, Axel Wirth, who I've interacted with for a decade and has written textbooks in the space. And so it was a way to continue where you got to really work with smart people and continue to have that intellectual stimulation that watching TV or picking up whittling doesn't give you. [00:22:16] Lindsey Dinneen: Fair, but those two activities on occasion could be good for your mental health, which we were talking about. So you can have both. You can have both. [00:22:26] Ken Hoyme: So my eldest daughter, when she was going through undergrad, wanted to take a class. She went to Luther College in Iowa, which was a very Scandinavian Norwegian school, and there was a class on Scandinavian whittling. And she really wanted to take it, and she did, but she was going into dental school, and so there was this paranoia about her slicing something important in her hand when she was whittling. She whittled with Kevlar gloves on! [00:22:54] Lindsey Dinneen: Oh! [00:22:55] Ken Hoyme: So there's a certain amount of connection, potentially, between whittling as a hobby and that blood thing that I didn't like, so that hasn't necessarily attracted me retirement hobby. [00:23:04] Lindsey Dinneen: That's a fantastic story. I love that. I wonder, you know, with her whittling skills, did those help her in her dental practice? [00:23:12] Ken Hoyme: She stopped it after undergrad. She also no longer plays the oboe, though she had an oboe scholarship along with her sciences because the finger stretching on the oboe ,she has all of the finger exercises she gets at work and doesn't really think she should be taking the risk of fatiguing it more. And so yeah, being safe in that environment has been important. So I think the thing that actually did the best for her is playing video games. She played things like Mario World, where you're having to constantly in your brain translate going around sphere things and jumping. And that's when you're looking through a mirror and drilling in the back of the mouth, you're constantly doing these translations. And so I'm convinced that all the video games she played growing up really gave her the spatial skills that help, particularly as she took the exams to get in, they do try to assess whether somebody is capable of that before you get into dental school, because you don't want to get in there and start getting into drilling and having somebody who just can't make their brain do that. [00:24:17] Lindsey Dinneen: Thank goodness. [00:24:19] Ken Hoyme: Exactly. [00:24:20] Lindsey Dinneen: That's fantastic. [00:24:21] Ken Hoyme: No wonder why people are afraid of the dentist. Maybe they had one of the bad ones. [00:24:25] Lindsey Dinneen: Right. Yeah, exactly. Oh, my goodness. Oh. [00:24:28] Ken Hoyme: And then I had already alluded to the fact that I'm, I'm doing volunteer work at HSCC on the joint security plan. And then the other thing that I did this last winter, and we'll be repeating this, is I had developed and taught a master's level class in medical device cybersecurity through the University of Minnesota's Technological Leadership Institute. And so after giving it once, they decided to make it a core curriculum for their medical device innovation. So it will be scheduled to be given annually. Things like the FDA keep coming out with new guidances, even while we were giving it last winter, one of the things that would happen each week is, this week, this got replaced. It's kind of this constantly changing environment that happens in this space. [00:25:13] Lindsey Dinneen: It keeps you on your toes and it keeps you learning and growing. I guess that's a great thing. [00:25:18] Ken Hoyme: I can't claim I've been bored. [00:25:22] Lindsey Dinneen: Brilliant. All right. Pivoting just for fun. Imagine someone were to offer you a million dollars to teach a masterclass on anything you want. It can be in your industry, but it doesn't have to be. What would you choose to teach and why? [00:25:37] Ken Hoyme: My first thought might be a master class in how to hide out with somebody's million dollars and not get caught. Being realistic, if I was teaching in my domain, I would probably want to expand out things related to security and safety and how that really is my technical expertise. If I was going to jump out of domain, you know, just something that, might seem off the wall would be a masterclass on the design and physics of the pipe organ. [00:26:09] Lindsey Dinneen: Oh, tell me more. [00:26:12] Ken Hoyme: When I was growing up, I studied the classical organ and sang in choir, was in the all state choir in high school and came out of high school thinking, music major, engineering, music, and I ultimately decided I could do music on an engineer's salary a lot easier than the other way around. And so I had twice been on pipe organ projects at churches I've attended where they brought in and bid and had a pipe organ builder install. So I've been close to that process. When I've been over in Europe, I seek organ recitals. So I've gotten to hear many instruments in Europe that are older than the United States. [00:27:00] And so, yeah, that's always been a passion and fascination of mine because there's such a engineering aspect of that and yet so much of it is musicality. And I've learned a lot interacting and talking with these builders. If I had a million bucks, I would be able to dive deeply into the topic and try to flesh out something that would actually be more comprehensive. [00:27:23] Lindsey Dinneen: Amazing. Okay. So I have to ask you, since you are a pipe organ enthusiast, how do you feel about the fact that there's quite a lot in pop culture of, it's being a vilified instrument, you know, you have the Phantom of the Opera, and there's like a Disney something that has a pipe organ that's a bad character. And how do you feel about the fact that pipe organs are used as villains? [00:27:48] Ken Hoyme: It's always an interesting thing when popular culture adapts something that is so much deeper. As a totally different but slight example, the accordion has always made fun of it. I don't remember how I tripped across it, but there is a very famous organ work by Olivier Messiaen, a French composer, which is-- I think it translates from French to English, "The Epiphany of the Lord." It is a multi-part work related to the Christmas story, and it is incredibly complex, somewhat challenging to listen to, you have to be quite into it. But there is a movement called Du Parmanu, which is, " God Descends and Becomes Us." And it is one of the most bombastic, just these big, huge chords. It's just exciting to hear. [00:28:40] And back 20 years ago, I heard or saw something about a Russian woman who had recorded the entire suite on accordion. And here in the Twin Cities, and it's nationally distributed, but I don't know how many different places, there's a gentleman by the name of Michael Barone who works for Minnesota Public Radio, who for 30 years plus has produced a weekly radio program called Pipe Dreams, all about the pipe organ and that. [00:29:10] So I ended up ordering, because I had a friend who was Russian and was only available on a Russian Amazon kind of equivalent, copies of it and sent a copy to Michael Barone and he actually played an excerpt. I think he did the Du Parmenu section on his radio program. And it's in countries like Russia, the accordion is treated very much differently than in Western countries, where it's more of a polka accompaniment. And so it's different instruments have the different faces, depending on how they're viewed and who's viewing them. So I just tend to look at the mass media view of it as the unwashed heathen. [00:29:48] That said, there is a woman who is bursting onto the scene, she's 26, I think, British, name is Anna Hapwood, and she has been making TikTok videos of her playing the organ, including at the, the Albert Great Hall that they do the BBC proms, and she is popularizing the instrument through her TikTok videos. I think it was CBS Sunday Morning, I saw her interviewed about how she's popularizing the instrument. You never know with the modern media and music distribution, how somebody might reinvigorate interest in something that was viewed as old fashioned before. [00:30:26] Lindsey Dinneen: Yeah, I love that. I love that. And I think it always depends on context. All sorts of instruments, for instance, could be used to be very light hearted and fun or very serious and mysterious. And part of it is just, yeah, are you playing in the major or minor keys? And, all the things that go into it. But anyway, it's just funny because pipe organ, I feel is one of those instruments that is a little polarizing [00:30:50] Ken Hoyme: I understand that. I was warped as a child and the interesting merging there is my father was a serial hobbyist. And when he went into a hobby, he went in 110%. And when I was growing up in my formative years, he was into gardening and breeding his own Asiatic lily types. And we had flowers everywhere and garden clubs would come through and tour the garden. [00:31:23] Then he went cold turkey on it and decided to build him an electronic organ in the basement and he built it from initially a kit and then through other designs that he did. And so I was in fifth or sixth grade with the soldering iron in my hand, helping build this electronic organ. And it was, part of what I view, my dad, his dad died in the Great Depression. He came out of World War II and really had to support his mother and sister, and never really had the money for college-- he would have been a great engineer-- but instead he manipulated my brother and I to both become electrical engineers, and part of it was by these, so part of my interest in organ was also my father's manipulation of getting my brother and I both interested in electrical engineering. [00:32:11] Lindsey Dinneen: Hey, it worked out. I love it. Okay. [00:32:14] Ken Hoyme: My brother has a church organ in his basement, so it took a little heavier with him than it did with me. I enjoy it being played but I don't play it myself anymore [00:32:22] Lindsey Dinneen: Ah, understandable. Well, what is one thing you wish to be remembered for after you leave this world? [00:32:24] Ken Hoyme: Number one would be that I didn't overstay my welcome. I would hope to be remembered that I made lives better, I made lives safer. That attention to detail matter and I worked on things that were significant, that actually had meaning for people's lives. When I moved from Honeywell to Guidant, I said, I used to be worrying on things that if they failed, people might die, 375 people at a time. And then you get into medical devices and now you're working to save their lives, one at a time. I would hope to be remembered that I worked to make a difference and had positive impact on people's lives. [00:33:03] Lindsey Dinneen: Yeah. Of course. Yeah. And then final question, what is one thing that makes you smile every time you see or think about it? [00:33:14] Ken Hoyme: I would have to say my children. Yep. I'm incredibly proud of them. They're both, both professionals, a dentist and an audiologist, they have remarkably snarky sense of humor that I presume they got from their mother. My story on that one was, I was telling my eldest one time, she said something snarky and I said, "Kirsten, you are the queen of snark." And her instant response was, "Yep, broke it, you bought it." But yeah, as you think about what you leave behind in the world, and I'm incredibly proud of them and the things that they've learned. They both secure, use individual passwords on every website and deal with the internet with the sufficient paranoia that they should, so I'm proud of that as well, but yeah. [00:33:57] Lindsey Dinneen: Excellent. Well, It sounds like you raised them right. [00:34:01] Ken Hoyme: They're great kids. They had to live with growing up with their dad being an engineer. [00:34:06] Lindsey Dinneen: Yeah. But it looks like it all worked out beautifully. So I'm very glad to hear all that. Ken, this has been so much fun. I really appreciate you joining me today. It was great to hear about your background and your advice, and I loved especially hearing about some of the little nuances that I wouldn't have gotten to otherwise, like pipe organ interests. So that's fantastic. We are so honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational, and safe environment. So thanks so much for choosing that organization to support. And we just wish you continued success as you work to change lives for a better world. [00:34:54] Ken Hoyme: Thanks, Lindsey. I really enjoyed chatting with you. [00:34:57] Lindsey Dinneen: Yeah, same. And thank you so much to our listeners for tuning in. And if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two, and we will catch you next time. [00:35:10] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Dr. Kenneth Brown is a private gastroenterologist with a clinical research division at Atrantil. Dr. Brown shares his journey from traditional medicine to a more holistic approach, blending natural therapeutics with traditional methods to treat gastrointestinal issues. He also discusses the advantages of being a generalist, how to care for your microbiome, and the need for more education about the link between gut health, brain health, and overall wellbeing.  Guest links: https://www.linkedin.com/in/kennethbrownmd/ | https://atrantil.com/ Charity supported: ASPCA Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editor: Tim Oliphant Producer: Velentium   EPISODE TRANSCRIPT Episode 021 - Kenneth Brown Lindsey Dinneen: Hi, I'm Lindsey with Velentium and I'm talking with MedTech industry leaders on how they change lives for a better world. Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome to The Leading Difference Podcast. I'm your host, Lindsey, and I am excited to introduce you to my guest today, Dr. Kenneth Brown. Dr. Brown is a private gastroenterologist with a clinical research division. In his practice, Dr. Brown uses a mix of traditional medicine and natural therapeutics to treat patients suffering from gastrointestinal issues. He hosts the Gut Check Project podcast where he and his team address topics surrounding gut health, healthcare economy, patient safety, nutrition, and more. Thank you so much Dr. Brown for joining me today. I am so excited that you're here and welcome. Dr. Kenneth Brown: Thank you so much, Lindsey. I'm super excited getting to be a guest on The Leading Difference podcast. Awesome. I typically am always asked to do medical stuff, so this is a little bit out of my scope, but very exciting nonetheless. Lindsey Dinneen: Great. No I'm very excited to have you and talk with you, and I would love if you would start by just telling us a little bit about yourself and your background and how you got to where you are today. Dr. Kenneth Brown: Yeah, absolutely. So I'll take you way back. I was in medicals, I basically raised in Omaha, Nebraska. I was in medical school scraping ice off my car and realized one day, "I don't have to do this." And so I immediately drove down to Texas as quickly as I could, did my residency and fellowship, and became a gastroenterologist and still residing in Texas. I seemed to like the warm a little bit more than that scraping ice off cars. So I started my practice about 20 years ago. Initially, I started doing clinical research specifically for the pharmaceutical industry. And I was helping launch some small biotech firms that were developing products. We were doing research for them, and in that time I realized there was this unmet need. In other words, no drug was being developed, or no drug existed for this big space called irritable bowel syndrome. I started to do research for the first drug that was trying to address this when I was in training. IBS, Irritable Bowel Syndrome, was considered more of a psychological diagnosis and literally I was taught that if you do tests on people and everything is normal, then more than likely, it is a psychological thing. We used to think the same thing about ulcer disease. Whenever it was 50 years ago, if you got an ulcer, it was because you were too stressed. You need to back off work, do something like that. Then we found out that it was probably due to a bacteria called Helicobacter, H Pylori. And the person that discovered that got a Nobel Prize. That same massive paradigm shift was starting to take place when I was doing this research about 15 years ago. And that was that a doctor had shown that irritable bowel syndrome is actually caused by bacteria growing where it shouldn't be. And that's called small intestinal bacterial overgrowth. So it's just that bacteria growing where it shouldn't be. And I was doing the clinical trial for them to look at treating people that had irritable bowel with diarrhea and in passing, I was having a conversation with the lead investigator and he said, unfortunately we'll never be able to help the bloated person with constipation because the type of bacteria that is causing it is a very old, ancient type called archaebacteria, and no modern antibiotics affect it." And that was kind of interesting. And and he said, "the issue is that this type of bacteria produces a gas called methane." So I'm writing on my whiteboard in my office, "archaebacteria methane." And I start thinking, I started the story in the very beginning, 'cause I said I was raised in Nebraska and I scraped ice off my car to come down in Nebraska, the prime export would be agriculture. And what they were trying to do is mandate that these ranchers and farmers give different feed products to the cattle to decrease methane production that they're admitting for the Greenhouse Effect. And I looked at that and I just went, "they've been trying to do this in Nebraska for a really long time. What is it that they're giving these cattle and can it be transferable to humans?" And so that sort of started the "aha!" moment of a bloated cow producing methane could be something eventually that might help the millions of people, and I mean millions, like 20% of the US population suffers from some form of irritable bowel syndrome and many more suffer from bloating and have never been diagnosed. So I spent the next several years, me and my research manager, and we were looking at all the data in animals, and then we came across this combination of three large polyphenols, which are the molecules that make vegetables and fruits colorful. And realized that one of the major ones in there is something called Quebracho Colorado that had never been used in a supplement before, but it is used in wine making and beer making and many other things that humans are already consuming. Went through some trouble of trying to get some Quebracho. This is in the like, weird things that happen with entrepreneurs. The only place that it is being developed is Argentina. And I happen to be half Argentinian, so I'm emailing, I'm calling, I'm trying to do anything to get hold of somebody to get me some of this product up just so I can do a clinical trial on it. And nothing was happening, I'm getting no response. And so I actually called a cousin who's a physician in Argentina. She physically drove to the manufacturing facility, walked in an office and said, "there's a doctor in Dallas that's needs your product. He thinks he found a reason to give it to humans." And so that started this whole domino effect. And then eventually I get this shady bag of material sent to my office and I had to spend a lot of money to have analyzed and everything because they're used to working in the agricultural business where they would just send bags of stuff. And so I was able to get this analyzed and all this other stuff, and then we encapsulated it and then put it with a few other things, and then ultimately did two clinical trials and found that it was remarkably successful in this patient population. And, we were able to launch this company called Atrantil. And that was about seven years ago that we were able to actually launch the company. And we have just been learning more and more about the science of all of this. I've been fortunate enough to do this at the exact time where you and I were talking off air about where there seems to be this push for more awareness about nutrition, more awareness about doing things naturally, and not always relying on drugs to do everything. So I feel like I'm very fortunate to be in this great space, learning a ton. And being able to help millions of people at the same time. So that's where we're at now. Lindsey Dinneen: Yeah. I love your story. Thank you for sharing that. There's a few different things that really stood out. First of all, I'm curious, did you always want to be a doctor? Is that something that was always a bit of a goal for you, or what made you decide to go into the medical field? Dr. Kenneth Brown: I don't know how detailed you want to get into this, but I will tell you another quick story since this is, that one's very specific because, when I was in eighth grade, summer of eighth grade, my childhood friend got severely burned when he was on vacation with his mom. Third degree burns, ICU, whole nine yards, both him and his mom. And I get a call, you know, I was in touch with him, this is back before cell phones, so it's landlines. I get a call from him and he goes, "they say that I need to get outta the hospital because, mom needs to stay in here a little bit longer." Like they were in the ICU for a long time, so he had skin grafts and everything. And I said, " just come live with us." And didn't even ask my parents and I just said, "Junior's gonna come live with us." And so he came and ended up spending a year living in our house and I was changing his bandages and all this other stuff. One night, at like 8:00 PM at night, doorbell rings and it's a guy-- introduced himself, his name was Leonard Woods. He said, I'm a physical therapist. I hear you have a young man who could use little help. I'd like to volunteer my services. So he just basically rehabbed and then we all became friends, all of us. And of course I'm watching this guy that comes over and volunteers his time and I for sure am gonna be a physical therapist now. And I'm like in ninth grade, go through high school, always kinda shadowing and then during college doing some internships and stuff. And this guy saves my friend and he's this super cool dude and this is what I'm gonna do. And then he pulled me aside and he just said, "Hey, I know that you think this is what you should do, but I really think your calling is to be a doctor and I think you need to apply for medical school." So I went, "okay." I just, at this point, I'm gonna do something in healthcare, just to help people. And the fact that your hero slash mentor is telling you to not do the job he's doing that he loves, I'm like, "okay, I guess I'll apply to med school." And then I ended up graduating college early, so I got a chance to spend a year, and I worked officially for him and he knew I was going to med school and then he spent that year teaching me how to manage employees, teaching me how to manage patients, how to run a busy clinic. And he just said, " dovetail me so that you can see how the business side of this stuff works." And I was fortunate enough to go to medical school already having some idea of how I would do this and then I thought I would be a surgeon and then quickly realized that's a horrible lifestyle. I think I need to shift gears and was internal medicine. And then found gastroenterology and that fit me like a glove. So a gastroenterologist is an internal medicine trained doctor, so they already have a predisposition for a little bit of intellectual curiosity, but you get to do procedures. So you get to get in and immediately fix or help or prevent various diseases. And so as a gastroenterologist, you basically are treating things from the esophagus to the anus. So I got into fellowship to be a gastroenterologist. I'm loving it. And then that's when I started realizing, "wait a minute, all health begins and ends in the gut." I was seeing all these people, they had gut issues years before they had something else. Everybody would complain that they had something else, and so, when I started private practice, that's how come I was drawn immediately after just a few years, I started the first research division of our company and I did research for about 10 years and it was just this beautiful sequence of events that led up to that point where I'm thinking about a bloated cow. I mean, it took a really nice physical therapist to show up and then physical therapist to tell me to do something different-- possibly more, depending how you look at it-- and me to realize that all health begins and ends in the gut. And I basically continued that with that complete curiosity. And I'm continuing to learn all the time as everyone else is, as we're all learning that the gut is probably the root of disease and health. Lindsey Dinneen: Yeah. Thank you for going to that story. I love hearing the why, what prompted somebody's interest or passion in what they're doing, and it really struck me-- both kind of stories you've shared with me so far about how synergistic from an outsider's perspective your life has been in a few different ways where like, seemingly no connection. So grew up in, in Nebraska and just you didn't like the snow, which I totally relate to by the way, side note. And then drawing from that experience is what helped you translate that into your work more recently. And that, that seems so disjointed, but it actually was this synergistic connection. And then you also have something like, you mentioned the one random place in Argentina and you had the connections, and I just love those stories when what's meant to be comes together in such a way that you could never predict. Dr. Kenneth Brown: For sure. And the other thing about it, you say the story, but I look back and it was months and months of just radio silence. But I knew that we had something there. So it was me asking around, call my mom, "do we have anybody in this part of Argentina?" And so it took that continual pursuit of doing that. It wasn't just, oh, dumb luck. It's there, but it's the knowledge that it's there and it's the knowledge that you have an angle and it's the knowledge to utilize your network to try and get there. The story sounds like it just kind of fell in place, but I think with every entrepreneur that you speak with, there's that classic line, "it only took 10 years to be an overnight success." There's so much more that happens back over here. And I look at this and I realized that some of these decisions that were made-- I don't know if you gave me another shot at this. Do you ever think about this? I mean, you have this incredible dualistic career of being a ballerina and then being in the medtech, entrepreneur space and marketing and it's funny 'cause you love your life and you've got this great situation that you have going, when people say, "would you ever do it again?" I'm like, "no, no way. 'cause I don't know if I would make the right decisions, even though I know what decisions I made. I don't know if I would make the right decision to get exactly where I'm at right now, 'cause I kind of feel like I'm just beginning about where we can go with all this." Lindsey Dinneen: Yeah. But that's the fun part, right? So it is kind of an interesting exercise to look back and think about the "what ifs." And if you were to redo it, would you make the same decisions? I've thought about that many times with different aspects where I chose between two seemingly really good options, but I'm so thankful I went with the one I did because that got me to where I am now. But you know, I was chuckling about your overnight sensation comment and I have thought about that so many times where, agree-- from an outside perspective it always looks different-- but I've always appreciated the quote, something like, "the harder I work, the more luck I have," or something like that, Dr. Kenneth Brown: Exactly. Lindsey Dinneen: I also think there's something to be said-- you talked about drawing on your network and the months of work that it did take. But I do think that there is something to be said to being open to possibilities that you wouldn't ordinarily pursue, or opportunities that you wouldn't ordinarily consider, because sometimes those, again, seemingly random, disconnected moments, somehow do all come together. And it might not be this overnight thing, but... Dr. Kenneth Brown: Have you heard of a book called "Range" by David Epstein? Lindsey Dinneen: Nope, but I'm writing it down. Dr. Kenneth Brown: So the book is called "Range: Why Generalists Triumph In a Specialized World." It's really interesting because it's an analysis-- who's looking like business leaders and things like that, and generalists that learn a little bit-- it's always thought like in medicine it's " jack of all trades, but master of none." So it's that whole thing of jack of all trades, but master of none. And so in my field, you wanna become the most specialized of subspecialists that just, you're the expert. And I think because of my path coming in, there was never this devotion to this one thing immediately or I'm gonna be the experts' expert. I'm a generalist in life and I eventually end up in this space of a specialized world. But I seem to be better off 'cause I was a generalist. And what I mean by that is in his book, what he describes is that when you have lots of life experiences-- if you've been in marketing for a little bit, and then of course you did have that, brief minor in accounting during college, and then you dabbled into sales over here-- and what he showed is that if you are adept at looking at this and you're still passionate about everything, you make the neural connections between these different experiences so you can see a connection between something where others are not. And almost by definition, that's kind of what genius is, where you can continually see things and go, "yes, this idea over here relates to that article that I read five years ago." I see where this happens, and that's how you end up having an electric car company and a rocket company and a whatever that Elon Musk does, right? He's just pooling from all this knowledge and forming something. So I think that is probably the most important thing, and I'm, and I say all this because my massively transformative goal for the rest of my life is to cure something that to me is the, like, the worst thing that can happen, which is robbing you of your memories. So dementia, it's an epidemic and it continues to go on, and I feel like what you lose when you have any type of brain trauma, even minor trauma, CTE, when you have toxins, when you start developing Alzheimer's and things, you lose the dendritic, meaning the connections between the neurons that allow that use of prior knowledge to now be integrated with new knowledge. And so that's why I think it's so important to protect the brain through the gut. Is any of that making sense? I feel like it just went down a rabbit hole. Lindsey Dinneen: No, I love rabbit holes, first of all, so that's great. But also I think that is such a fantastic goal and it's so important and actually very encouraging to hear people working on these kinds of things, and the losing your memories and not being able to recognize people you love but realizing that maybe there are ways to slow that process or reverse or cure, that's a wonderful, hopeful thing. Dr. Kenneth Brown: So that's the thing. Nobody's talking about that, but there's so much evidence out there. So one of my most frustrating things being in this space-- so what's happened since the-- I did, traditionally trained gastroenterologists, and then I'm doing pharmaceutical research and then I figure out that there's this space where maybe natural products can start filling the void, and that has really just shifted me to what I would consider myself more of a functional gastroenterologist. I still do traditional gastroenterology stuff, but I sure would like to find a more natural solution before we just knee-jerk and put you on drugs. And one of my most frustrating things when talking to colleagues is, and I'm not throwing any individual under the bus here, but I start talking about, "oh, did you see this?" For instance, "hey, I just read a great article on the neuromodulatory effects of flavonoids, polyphenols, my world and gut microbiota through the gut brain access and how we can ultimately start healing our brains by having the right microbiome plus flavonoids. So that's an article. Just reviewed it. Super cool. Neat." And discussing that amongst my colleagues would be like there's no data on that. And I went to a meeting recently and I was preparing to give a talk on, if you keep your microbiome young, you'll stay young. And, and it's all about manipulating your microbiome. And there's evidence to show that our supercentenarians, the ones that live past 95 or whatever, they actually have a microbiome, the microbiome is the collection of bacteria in your body, the collection of bacteria primarily in your colon that they have their own genome. You and I have a 99% identical genome, but we could have a 90% different genome in our microbiome, which may be one of the reasons why I age quick and you don't, one of the reasons why I get cancer and you don't, got it? The microbiome, it's the collection of the bacteria in our body. So I was in a meeting, so I'm already preparing for this talk about the microbiome. And so I'm going to Croatia to give it. So I'm like really excited and it's, it's motivating 'cause I'm learning and everything. And I go to a meeting where a professor emeritus is gonna give a talk on probiotics and he gets up and the actual title of the talk was the "Probiotic Guide to the Gastroenterologist in 2023." And he said, "I think we can finally agree to this," and this is his words, "that the data does not support the use of traditional probiotics and we need to move away from this, and this is data. So some people do well in probiotics, but the data really is showing that probably traditional probiotics don't survive the digestive tract." And he said, "but what we really need to start thinking is we need to work on our microbiomes, but unfortunately, there's no data out there." I'm in the audience and I have a folder of about 200 articles and a Mendeley. Mendeley is a journal repository on my computer of like another 300, and I'm like, "no data out there?" And it just got me thinking. I'm like, unless you have a specific desire to go look at something, the data that you're referring to is when a drug rep shows up at your office and gives you a detail piece 'cause that's how we're being reminded that there's new research. Here's the new drug, not are there any new, because this is like bench research that's going on all over the world. Now we live in unprecedented times. I can find an article that hasn't even been translated in English yet, translate it from some postdoc candidate in Thailand doing crazy work on the stuff that I'm working on. And this is a true story. This is exactly what happened, and it's helping me develop more products because I'm like, "Oh, this person did do the heavy lifting already." And it was done 10 years ago and nobody's probably even heard of this. It's out there. It's just, do you have the motivation and the time to go look for things? Right now doctors are super busy and the time that they have is the five minutes they get with the person that brings them lunch. Lindsey Dinneen: Wow. Yeah. So pivoting just slightly. I'm so thankful again that there are people like you doing this research and analyzing this data and helping us live healthier, fuller lives. So first of all, just thank you for that. I am curious if there are any moments that stand out to you throughout your career as really affirming that this was the right career path for you. Dr. Kenneth Brown: Yeah. There was a-- I can't call it "aha moment" or anything. It is a, " you cannot not do this" moment, is what it came down to. So I'm an adult doctor and a woman who quit her job brought her 18 year old, severely autistic son in to see me. And I don't have any particular specialty in autism or anything like that. And what she said to me is, she goes, "I need help, 'cause he's now a young man. He's big and he's strong." And she said, "Nobody will take him. Like nobody will babysit him because he can be aggressive. And he's getting much worse with his autism and things are very rough on me, I had to quit my job. I have to spend all my time with him at home." And I said, "I'm just curious, why here?" Now this is years ago, so it isn't like I was really deep into the functional medicine yet. And she said, "I've noticed one thing. I've noticed that when he eats, he's much more combative, and he's non-verbal so his communication is just really limited." And she said, "There has to be something with his gut if it's doing this." it didn't take very long to realize that he was getting super bloated after he ate and his belly hurt and he couldn't say, "I'm hurt, I'm hurting." And so now we're in my wheelhouse. I started doing some research real quick and it's very evident that people on the autism spectrum disorder can have dysmotility or changes in the motility of their intestines, which can predispose to developing bacterial overgrowth, which is exactly my space now. And so we treated him and we treated him with both an antibiotic and my product and then changes diet. Changed lifestyle, change his diet, just made some changes. No processed foods. Don't open a bag. It's whole foods. I personally, with the way that we grow our crop, I really try and get patients to avoid gluten as well. I think it's very neuroinflammatory. And so she came back three months later and she was crying. And she was so happy. And this young man was calm. He was talking. She's like, "he can eat." She's like, "I haven't seen him like this in 10 years since he was like a little kid." And I'm like, "Okay, this is the n-of-1 that tells you, the brain and gut are connected and you have to keep pursuing that." And so that was oof, I dunno, six, seven years ago or guess well, like shortly after we launched. So I guess about, yeah, I dunno, six years ago or so. Yeah. So when you say that, I always think about that, if that's ever a case. I've heard that many other times since then and I don't think it's just the product or the antibiotics, I think it's the lifestyle change as well. Lindsey Dinneen: Yeah. And how it all comes together to support Oh my word. Wow. Thank you for sharing that story. That is really powerful and I can see why it would be such a moment that would make you say, "yeah, this is what I'm meant to do, this is the impact I can potentially have on changing someone's life." There's nothing quite like that. Dr. Kenneth Brown: Yeah. And then the more that you get into it, it just more reaffirming. So then it just becomes all consuming. You're like, you have to do this. And I think everybody that owns a business or is an entrepreneur-- I'm the visionary. We need an implementer to make things run at the company and all this. So if I had all the time and all the money in the world, it would just be 24/7 trying things out, looking at these natural products. The beauty is we're learning that the modulation of the microbiome, the gut microbiota, the thing that seems to positively affect them the most are these large, stable polyphenols. And it's these large, stable polyphenols that get broken down into smaller phenolic compounds that work in an anti-inflammatory way and can cross the blood brain barrier, which is what I think is happening. Just go ahead and name any neuro-inflammatory disease from anxiety, A D H D, dementia, autism spectrum. There's different neurologic mechanisms primarily excitability and overactivity due to inflammation, creating all of it. So knowing that's the root cause, where does most of the inflammation come from? It actually can start in the gut. So knowing that, how do we stop that inflammation? And then how do we improve the microbiome to produce anti-inflammatory aspects that then heal the brain? And the science is mapping out there. I think the traditional scientists will say that we don't know enough about it. And that's true, 'cause you can't manipulate it in a way that people wanna manipulate it, but, I'm kind of taking that functional approach. Let Mother Nature figure it out. Just give your body what it wants, give it the foundation. Make sure you have a good sleep. Make sure that you socialize. Make sure that you exercise a little and make sure that you eat the right foods and all of it will sort of work itself out If you have your foundation right. Lindsey Dinneen: Yeah. So last year, I had the opportunity to spend a little bit of time in Puerto Rico and there was this beautiful rainforest that we did a hike in. And it was really interesting, our guide was telling us that with the hurricane that they had just a few years back, had destroyed like, I wanna say maybe 80%, it was a very high percentage of the flora and fauna of the rainforest. And when we were there, there was no way we would've known that had she not pointed it out. And it really struck me how resilient living things are. I think about this with humans as well. And when you intentionally try to nurture and cultivate and take care of yourself or other living things, how much we can bounce back from and how much we can heal and regenerate and make new, and I just thought of that when you were talking about the possibilities that if we can heal our gut, maybe we can heal our brain and heal some of these other things that come from, from that inflammation. Dr. Kenneth Brown: Yeah, for sure. So let's use that same analogy with the hurricane, because what we do to our microbiome is a tropical forest. Exactly what you are walking through. There's trillions of bacteria. There's thousands of species. The more diverse it is, the healthier it is. Just like the rainforest you were walking through. Now you take antibiotics, you eat a highly processed diet, you do something to disrupt it. That's equivalent to that hurricane disrupting the rainforest. The difference is we continue to do that and what we try to do is, we try to take control of it and take drugs or take different things to try and say, "oh, I'm gonna heal it with this." So the equivalent would be, when the rainforest was knocked down, somebody comes in and goes, "the rainforest was destroyed, but what I'm gonna do is I'm going to plant anything, name it, corn. I'm gonna plant grass, anything." And so now you have a big lush field of grass. Now on the one side is just grass, and on the other side is a dense tropical forest. The dense tropical forest is the healthier version. We tend to focus on one bacterial species. That's where the science is. It's like, how do we grow more of this? How do we do more of this when it's the diversity that has to happen? They left the rainforest alone and it figured it out. And grew back quickly. The more that they would intervene with that, the slower that process would be. Lindsey Dinneen: Yeah. Thank you for taking my own thoughts and putting it in, into exactly what we're talking about 'cause I appreciate that. Okay, so I am gonna take the conversation slightly differently, so just for fun, imagine you were to be offered a million dollars to teach a masterclass on anything you want. It could be in your industry, could be related to your work, but it doesn't have to be. What would you choose to teach and why? Dr. Kenneth Brown: Oh my goodness, it's gonna be so boring 'cause it's, I mean, the masterclass would be this exact same topic. It's, you can protect your brain through your gut, would be what it is just because there's too much evidence that so little people are talking about it. And would it be a masterclass, 'cause I'm still learning? You'd pay me a million dollars and we would have to share it, 'cause it would be a group learning session. That's what it would be like. Everybody that attends, we all teach each other and share the million. Lindsey Dinneen: There you go. You can use part of it to further your work because you were saying, if you had unlimited resources, how much more could you do? So, we can share the love. Dr. Kenneth Brown: Yeah, I just, immediately was thinking, "my ego would not allow me to accept a million dollars to give a class". I'm like, "oh my gosh." What kind of a, like, there's my PowerPoint. Could never be that good deserving a million. Lindsey Dinneen: Oh, yeah. Like We'll just give it to your organization and I'm sure you could find good ways to use it. I'm sure that would be a worthwhile masterclass to take, and it would be just a good learning experience for everyone. So, good answer. What is the one thing you wish to be remembered for after you leave this world? Dr. Kenneth Brown: I wanna be remembered as a curious and kind person. Lindsey Dinneen: Yeah. I like that. And then final question, what's one thing that makes you smile every time you see or think about it? Dr. Kenneth Brown: Dude, I'm so boring on these questions. Like my knee jerk is like, oh, my family. I want to give something cooler than that. Oh my gosh. I try to practice some mindfulness type things. Have you heard of neurolinguistic programming? NLP? And so you know how there's an anchoring technique so that you can get yourself excited or happy? I will say that my happy memories would be, I took my family to Spain and we went to a Michelin star restaurant and had a chef's tasting menu there. And just thinking about that is my, anchoring to be happy. And then this summer, we went to Portugal and did the exact same thing, except the kids are older and all this other stuff. And so something that makes me smile immediately. Alright, there we go. It doesn't even have to be me. Something that makes me smile immediately is when people are loving and caring and they're breaking bread with each other over a nice Mediterranean meal. Lindsey Dinneen: That is a great answer. Yes. I would have to say that I, I can fully support that. I love both Spain and Portugal, and some of my fondest food memories would have to be there too. So see this. Dr. Kenneth Brown: It's just that feeling of, just openness and enjoying and discussing. There's something primal about breaking bread with other humans in a way that is, I don't know. And of course, it's a chef's tasting menu, so you don't know what's coming. There's that dopamine anticipation, and then it gets put down and it's like nine courses. It's just stuff like that that's awesome. Lindsey Dinneen: Oh, I love it. That's amazing. Thank you so very much for joining me today. This has been such a great conversation, and I learned a lot. I'm very thankful for the work that you do and just all the ways that you finding to help people live their best lives. I just wanna, again, say thank you for your time and as just a small token of that, we're honored to be making a donation on your behalf to the American Society for the Prevention of Cruelty to Animals, which is dedicated to preventing animal cruelty in the United States. And we just appreciate again, your time, your efforts, and we just wish you continued success as you work to change lives for a better world. Dr. Kenneth Brown: Thank you so much, Lindsey. Thank you so much for having me on. And I really enjoyed this and I enjoyed our 10 minute off the record banter and I feel like you would be a great guest on the Gut Check Project, my podcast, and we can talk about the ballerina days and all that. Let's do it. Lindsey Dinneen: That sounds amazing. Alright, well, thank you also to our listeners for tuning in and if you're feeling as inspired as I am right now, I'd love if you'd share this episode with a colleague or two and we will catch you next time.  The Leading Difference podcast is brought to you by Velentium. Velentium is a contract design and manufacturing firm specializing in the development, production and post-market support of diagnostic and therapeutic active medical devices, including implantables and wearables for neuromodulation and other class three indications. Velentium's core competencies include electrical design, mechanical design, embedded software, mobile apps, contract manufacturing, embedded cybersecurity, OT cybersecurity, systems engineering, human factors and usability, and automated test systems. Velentium works with clients worldwide from startups seeking seed funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Allison London Brown is the CEO of LUMINELLE 360, a company focused on improving women's health through innovative medical technologies. In this episode, she discusses the challenges of fundraising, particularly for startups and women-led organizations, and the importance of personal mission and storytelling in leading a company and securing financial backing. Allison also emphasizes her commitment to changing diagnostic practices for women's health, particularly uterine biopsies, by developing a device through LUMINELLE 360 that enables physicians to perform these procedures more effectively. Guest links: https://www.linkedin.com/in/allisonlondonbrown/ | https://www.luminelle360.com/  Charity supported: Tunnel to Towers Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Production: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 020 - Allison London Brown [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey with Velentium and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:10] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:39] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:43] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello and welcome back to The Leading Difference Podcast. I'm your host, Lindsey, and I am so excited to introduce you to my guest today, Allison London Brown. Allison is the CEO of LUMINELLE 360. She is a visionary leader with a passion for changing the lives of patients, providers, and caregivers and inspiring teams to achieve their full potential. She has experience working with startups, venture backed organizations, global partnerships and corporations, as well as associations, NGOs, and global government agencies. Thank you so much for being here. I'm so excited to talk with you. [00:01:28] Allison London Brown: I'm excited to be here. It's, it's great to meet you, Lindsey, and to talk to your audience, and I look forward to it. [00:01:35] Lindsey Dinneen: Wonderful. Well, I'd love if you wouldn't mind starting off by telling us a little bit about yourself and your background. [00:01:43] Allison London Brown: Yeah, so I am currently the co-founder and CEO of a company called Luminelle. And we in essence are a company that's focused in women's health. And we do that using our insights into what happens for women in diagnosis, especially in the office place. And we have a proprietary visualization system that physicians can use in their office. I wouldn't say it's just my job. It's actually a mission for me. [00:02:17] So a little bit about me. I am a recovering scientist. I started in chemistry and engineering, so I still have a little bit of that, I'm a nerd, whatever, and I was with J&J for a lot of years in GE and some really great, amazing companies and was trained in both the medical device and as well as in the consumer and pharma world. So I've had some really spectacular experiences with tremendous people and great physicians and their patients. And, I've been in the women's health industry for a really long time. [00:02:53] And in the company I'm in now, a few years ago, some physicians came to us and started talking about a problem that they were having and I had to say, I really didn't understand or believe it because I've been, again, been doing this for forever, and they were telling me that the difficulties of something as simple as getting a uterine biopsy. What we started looking into is that the failure rate for uterine biopsies is 50%. And that just seems really unacceptable, right? [00:03:29] And so then the more I dug into it, the more I was learning about uterine cancer and how it's the fastest growing mortality rate. And that African American women, if they're diagnosed with uterine cancer, they have a 90% mortality rate. Hispanics have a six times mortality rate. [00:03:50] So, just doesn't make sense, right? What is going on? And really what I discovered was that the way we do endometrial biopsy is they do it blind. So it's like this little straw that goes in to, to try to take a sample and you're not taking the right spot and you're not taking enough tissue. And so we get these really high failure rates. And the reason I'm saying all this about that is it was shocking to me, A: as a woman and B: as a person who felt like I was extremely knowledgeable and had been doing this for forever. So I was honestly shamed, that I didn't realize that this is such a major but small, a simple problem, right? [00:04:40] So we've shifted all of our efforts really into creating this new device that we are going to launch any minute now which is allowing physicians to do very easy sampling. And I will tell people it's the most meaningful thing I've ever done in my career. And again, had great opportunities to work on major launches, but this is, I feel like is kind of that legacy moment, people talk about that legacy moment and I feel like that's this for me. [00:05:10] Lindsey Dinneen: Oh, I love that. Yeah. You talk so much about it being so important and underrepresented and can't believe that there's this gap, and you know, that seems to be coming out more and more. There's so much more awareness, there's chatter, there's emphasis on women's health. However, there's also, it feels like there's still such a barrier to progress. Yeah, and I was wondering if you could touch on that, because obviously you're at the forefront of this. You are the one who is paving the way, but it is tough. [00:05:45] Allison London Brown: Yeah, so people always ask me this question about, oh, as a CEO, my job is 99% of the time I'm raising money. Right? That's what you do when you're in a startup. You're raising money. You can never have enough money. You're always raising money. And so the question inevitably is talking about all of the statistics about how women founders don't get cash and the VCs don't fund us, and blah, blah, blah, blah, blah. [00:06:11] Yes. Okay. So all of that may be true, but I do think that the bigger challenge is not 'cause I'm a woman, but because of the fact that I'm dealing in women's health. And, it's difficult. I've worked in a lot of different male down there care issues, and I have difficulty understanding all of it. And I'm sure that for investors ,who are predominantly male, are also struggling to understand why this is so impactful. I think the other thing is there's been so much legality in the United States around women's health. There's, lawsuits left and right, and so it does make some investors a bit wary. So on a positive side, we are seeing some significant wins when it comes to reimbursement. And so doctors are actually getting paid for their work. I think we're seeing some innovation come. But it's a whole lot too late maybe. I dunno, can I say that? [00:07:15] Lindsey Dinneen: Yeah, that's fine. . Yeah. But now you have a bit of a unique fundraising experience if I ascertained correctly through some of your posts, and one thing that really stood out to me is there was a comment at one point where you said something to the effect of, if you're not comfortable raising money or asking for money or whatnot, then maybe you need to find a different occupation or different job title. Yeah. Yeah. I love the boldness of that. I was wondering if you could elaborate a little bit on that, because obviously, like you said, that's a huge component of what you have to do. [00:07:54] Allison London Brown: Yeah, I mean, I think. The essence of all that anybody does really is we're all storytellers, right? We should all be telling a story. If you want someone to buy into what you're doing, whether it's to write you a check or to join your team, or to stay on your team, we talk about leadership and loyalty and recruiting and all these things, but in essence, all of those things really go down to, you gotta tell a good story. You gotta believe your story. And I don't mean like making up a story, I mean, you're sharing this common experience with somebody, or you're sharing how you've come to something with somebody. [00:08:28] And so I think the challenge is it's easy for some people to ask for a sale, right? I'm selling you a product, I'm selling you a widget, I'm selling you a contract, whatever that is. But when you are raising funds for your company, you're kind of selling yourself. You are saying to an investor, trust me. Trust my team. Trust that I am going to take care of your money. I'm a good steward of your money and that I will not waste your money. And not only that, but that I will give you a good return. [00:09:09] And I think when I talk to a lot of younger, newer entrepreneurs, the idea of selling yourself in a way and then getting the close on the deal, getting that check right? You gotta close the deal for whatever reason is very troubling for some people. And I mean, that's the whole point, "I'm telling you my story so you can understand why am I doing this, why I know I can be successful, why my team can be successful, and write me a check. Show me the money." [00:09:46] Lindsey Dinneen: Yeah. And now you have approached it in, well, my perspective, a little bit of a unique way, and that is that you mentioned at one point that you raise a lot of capital through your own networks and through maybe not just Angel Investors or VCs or whatnot, but that you have been able to draw on your own social network, and so I was wondering if you could share a little bit about that process and if it's still an option, what opportunities still exist for people to invest in your company? [00:10:18] Allison London Brown: Well you're welcome to invest, of course I'm always raising money, so, yes, thank you for asking. So the first part of that question, though it's kind of personal and I think people talk about doing like a friends and family round. That's not what I'm talking about here. The way that I have approached our fundraising, done a lot of Angel Funds, we've done a lot of high net worth individuals. We've been very judicious in our spend. We've been very fortunate. I mean, raised very little money, and have four or five, 10Ks, five patents, we're commercial, we've got contracts. [00:10:55] But we are now at that stage that so many startups find themselves in, which is, I hate this word, but it's the "valley of death" where you finally have got everything ready to go and you run outta cash. A lot of us are in that boat. This has been a horrific year for raising money. So I, earlier in the year really tapped into my network. But I raised actually a little bit over a half a million dollars in two weeks, and most of it was from people in my church and their contacts. [00:11:28] Lindsey Dinneen: Wow. [00:11:29] Allison London Brown: So when I talk about it being personal, when we say this is missional, it is missional on a mental, emotional level, but for us it's also on a spiritual level that we really believe in what we're doing and we believe that kind of, for such a time as this, is why we're doing it. There's a reason why this idea came to us at this time with this group of people, with these physicians, with the technology that's available today. And honestly, that's not lost on a lot of people who know me personally, they understand why we are doing what we're doing. We will not quit. we will do whatever it takes to keep us going. And so in terms of fundraising, yes, we are still fundraising. We have a note that's out. We are opening up a seed round in the first quarter. And we have some very big plans for how we are going to launch this product. Not expensive plans, but big plans. Anybody who's interested, you can find me on LinkedIn. I think I'm on the only last name, London Brown. So easy to find. [00:12:46] Lindsey Dinneen: Amazing. Yeah. I love what you said, and you've now said it a couple of times, of being so mission focused. Like this is not just a job to you, it's not just a company to you. This is a life's work and I love that. And I'm wondering if you can speak a little bit to, you've found this purpose, you've found this goal, and this mission to orient around and then how are you able to, like you said, story tell and express that to people who may not have experience or concern? [00:13:21] Allison London Brown: The organ! They, they don't have a uterus! That's OK. [00:13:25] Lindsey Dinneen: Exactly so, so, right, or people who might think, oh well, "I'm healthy, I'm fine." But that doesn't necessarily mean anything. So I just love to hear how do you share that heart and that passion and really help people care and understand like you do. [00:13:39] Allison London Brown: Yeah, I mean, it does depend on the audience and everybody will say that, " it depends," but it does. I mean, you have to know kind of who you're speaking to and what's gonna matter for them, what's gonna get them to a, yes. Typically when I'm meeting with a group of, especially let's just say older gentlemen, it's easier for people to think about, "oh, have you had a colonoscopy?" Right? "Have you had a skin biopsy?" Have you had, all these different things that we kind of take for granted, right? [00:14:08] These wonderful abilities to do diagnoses, and it's all driven by the ability to see. My business development manager, Jamie Harding, she goes on rant all the time about how sight is one of the most critical things in medicine, and yet here we are doing something blind. And, for a typical biopsy, the failure rate is 2%. So I think for a lot of guys they can get their head around, "oh, can you imagine no anesthesia, and the doctor starts just using some probe, and no camera, and it's just like digging around to try to figure if you have a problem." Okay. [00:14:56] Or, you know, it's hard sometimes, but it's like getting a root canal without anesthesia and he's not looking. I mean, it's, there's a lot of different ways could say this, but at the bottom of this, it's like you gotta be able to see, right? So that's not a hard thing, I think for a lot of them to understand. Many times I'll spend more time talking about the technology, or I'll talk about the dollars, the actual economics of the situation versus the problem itself, because that can be, again, it can be a little bit distressing for some audiences. [00:15:30] But, get 'em in the mindset of what if this was happening to you, and then what if this was your mother or your sister or your daughter or your granddaughter, you know? And she goes in, she has this horrific experience. It's extremely painful. And then. You wait a couple weeks and the doctor says, "oh well, either we didn't find anything or we are not really sure because it was Inconclusive." Inconclusive! That is the word that nobody wants to hear, right? [00:16:05] Lindsey Dinneen: Yeah. Yes. [00:16:06] Allison London Brown: Inconclusive. What does that mean? You can't tell me what's wrong with me. So yeah. [00:16:13] Lindsey Dinneen: Yeah, so part of it definitely is sort of putting it into almost like, like you gave some great examples of putting it into terms where it's like, yeah, "can you imagine if you had a root canal where the dentist wasn't looking at you , and you had no anesthesia, what would that feel like?" That's ridiculous , and there's a solution for that. [00:16:35] Allison London Brown: The other one is, I like this one, is a skin biopsy. You go in, you have something on your arm, you can see it, it's on your arm. Everybody can see it. It looks weird. Your wife has said to you, "you need to go get that thing checked. You need to go get that thing looked at," as we would say in the south. You go into your doctor, the doctor sees it, the doctor gets out a tool, then the doctor turns off the light and then tries to find where it was. I mean, it's kind of that same thing. Things you don't do blind. This is like a whole, like if I had a bazillion dollars, I'd be doing commercials about things you don't do blind, right? [00:17:10] Lindsey Dinneen: Yes. Oh, I love that though. . I'm already starting to think of so many great ideas with that particular... [00:17:17] Allison London Brown: Exactly. [00:17:19] Lindsey Dinneen: You know, looking back, let's say years ago, and I recognize this as a little bit of a, a newer venture, although you've been very involved in med tech and science your whole life, did you always have an interest in science and healthcare from an early age? Is this something that you thought you might ever do or was this sort of a, an evolution over time? [00:17:39] Allison London Brown: I can tell you the exact time where I decided this is what I wanted to do. So in high school, I thought I was gonna be a musician. I actually had a full scholarship in music and piano, voice and drama and really thought, that was my journey. And I took a chemistry class. I had put it off until my senior year. And fell in love with chemistry. I mean, I always liked math and then, at the time there were all these really interesting things going on around genetics and just so many different breakthroughs in medicine and I just felt like that was my path. So I started studying in chemistry. I started looking at the different careers in chemistry. I knew I didn't really wanna be in the lab, I didn't wanna be like a bench top scientist or anything like that. [00:18:37] But medicine was so intriguing, I kind of thought that I was gonna go be a researcher at like NIH or National Cancer Institute or something like that. Some big, huge impact on the world. And, over time, I just, I found myself feeling more and more drawn to really understanding another form of science, which is understanding, "why do people make the decisions they make and why do they buy the way they buy?" Which, you know, behavioral decision making. And so marketing and sales was very intriguing to me. So I think I've I just leveraged a different part of my brain on the commercial side to really figure out how do you get someone, again, you get somebody to that yes. [00:19:26] Lindsey Dinneen: Yeah. So very multi-passionate and multi gifted. Do you still do anything with music, voice, or drama, out of curiosity? [00:19:36] Allison London Brown: I don't do drama anymore. I mean, well, ask my friends-- might tell you I'm dramatic all the time. I don't, I dunno that I am, but don't like drama. Let's just that way. I try to avoid drama in my life. Look, I'm very comfortable in front of an audience, and think all that upbringing of being on the stage, and I had the opportunity to sing at the Grand Ole Opry, so it wasn't a foreign concept to be in front of a large audience. I think that's very helpful. I'm in a band at church and I do that kind of stuff, but I don't have time anymore. I, you know, I'm trying to raise money. Right. I don't have time for that. [00:20:12] Lindsey Dinneen: Right. But I love how that performer background may have helped contribute a little bit to your comfort on stage and giving presentation, being in front of people because that would be a very useful skill that, that, would intimidate some other people sometimes if they're suddenly in this role where, oh my gosh, now I have to be the face of the company, which means I have to do Y, and Z. [00:20:34] Allison London Brown: Yeah. Right. Isn't that like the number one fear I think people have is speak in front of a crowd? [00:20:39] Lindsey Dinneen: Yeah, . So there you go, you already had a little bit of an edge there 'cause you had that comfort, that's amazing. . [00:20:46] Allison London Brown: Yeah, I mean, I think that's helpful, but and I tell people this all the time, again, if you cannot communicate your ideas or your story, then it is gonna be very difficult for anybody to buy in. I may have been a scientist, but again, that training in drama I think helped because a lot of people in science, they have a hard time articulating their ideas at a level that if you're not a PhD, you can't understand it. I am not a PhD. There are many brilliant people around me all the time and I'm like, "can you please dumb it down for me." Like I can't communicate it back to you in a way that makes sense, it's not gonna stick with anybody. [00:21:29] Lindsey Dinneen: Yeah. And speaking of not having time anymore, you are a board member of multiple other organizations. Can you share a little bit about that? And also, do you get a chance to sleep or... [00:21:43] Allison London Brown: Yeah. Yeah, I've actually had to back off some of my work. I've been involved with CED, which is the Council for Entrepreneurial Development here in Raleigh, for a long time. I guess 10 years. And this year I've had to really back off of that work, even though it's a passion of mine to help other entrepreneurs. I do sit on the board of Clayco Therapeutics. I really believe in what they're doing. They're working on a new biologic for necrotizing enterocolitis, and I know that's a big word, right? Basically it's when babies are low birth weight or premature, we talk a lot about like lung development, right? They can't breathe well or whatever. A lot of times their gut doesn't work, so their stomach doesn't work, and there's not a good diagnosis for it at all. And there's also a really not a great therapy for it. There's not like a drug. Some of these kids end up having multiple surgeries, it can lead to slow development, it can cause, just a myriad of other really horrific things for kids. And so they have a product that we believe is gonna be able to literally reset the gut, and allow the children to be able to feed properly. So I mean, these are like itty bitty little babies, right? So it's, I guess, adjacent to the women's health world, but it's, I just think it's a fascinating area of medicine, which is biologics, using natural substances to heal our bodies. [00:23:15] Lindsey Dinneen: Yeah. [00:23:16] Allison London Brown: Not synthetic things. And its a great mission, yes, I do get to sleep. [00:23:20] Lindsey Dinneen: Okay, good. [00:23:22] Allison London Brown: I do get to sleep. But I do try to get involved in things that, A) where I think I can add value. I try to get involved in things where I really know make a difference or help the entrepreneur, and it's something I, I believe in. [00:23:34] Lindsey Dinneen: Yeah. Oh, I love that. Yes. And paying it forward is such a wonderful thing. So what are you looking forward to, as the company continues to move forward, either personally, professionally, what are some things that you're looking forward to? [00:23:48] Allison London Brown: I'm looking forward to a vacation I don't, dunnah know if that's a good thing to say, but I'm looking forward a good, a vacation, that would be nice. We did not do a vacation this year 'cause it's just been one of those years. No, so in terms of the company, I have this vision in my head of having a building and having 20-30 people and 10 to 15 sales reps and just this humming, working, hive of people all focused in the same direction, working and aligned on the same outcomes, and just this community of believers that have come together to really make a difference. So I kind of have this idea of that place where we are all together doing something. And I think that could happen for us this year. So I'm extremely excited about that and giving people jobs, right, and giving people an opportunity to join with us in this mission. So that's exciting for me. [00:24:53] Lindsey Dinneen: Absolutely, are there any moments in particular that stand out to you, that really solidified for you, "yes, this is why I'm here doing what I'm doing"? Because of something that happened that just was such a reinforcement of, "yes, I'm in the right place at the right time." [00:25:13] Allison London Brown: Yes, I have. Two things. The first thing is we were doing research around this new biopsy tool and listening to physicians talk about what they're doing today, how they're doing it today, and hearing. doctor, after doctor say, "what I'm doing today is just fine, not good, not great, just fine." And I thought, "you gotta be kidding me." Like, how is that an acceptable answer? And not trying to diss the doctors, please. That's not at all what I'm trying to say. To me that just sounded like they have acquiesced or they don't feel like anybody's gonna pay attention to them or their plight or their concerns. And so why bother? And it felt very defeatist. Again, for people who-- my friends who know me, like, give me a challenge. Like, just go ahead, tell me, "no." let's see where that goes. So that was one thing. [00:26:20] The second thing is much more personal. And in my prayer time, in my devotional time, in my, crying out to God to ask him is "Is this really real? Is this really gonna happen? I'm running outta money." All those fun things that we think about as entrepreneurs, "what am I supposed to do?" kind of at your wit's end and just having this huge sense of, " yes, move forward. Yes, go forward. Yes, I'm here with you. Yes, I'm in it." And I know that sounds kind of kooky, for people who are not maybe into that kind of thing, but a few years ago I would've said, "that's crazy." But I will tell you, it was extremely meaningful event for me and it stays with me. It keeps us going because I just, I believe in us. I have faith that this is what we're supposed to be doing. [00:27:19] Lindsey Dinneen: Thank you for sharing those stories. Those are both very meaningful and it is encouraging because feeling that belief and that reassurance that "yes, you're in the right place, doing the right thing at the right time" is so important because it's not easy. Nothing about what you're doing is easy , so you have come back to that. [00:27:40] Allison London Brown: Yeah, and I feel extremely blessed that I do have that, because I, a lot of my friends are thinking through what is their purpose? What should I be doing? How blah, blah, blah, it's tough when you are seeking for something that's meaningful, right? And I do believe that we've been given that opportunity. [00:28:00] Lindsey Dinneen: Oh. I love that. I, yeah, absolutely love that. Pivoting just for fun, imagine someone were to offer you a million dollars to teach a masterclass on anything that you want. It can be in your industry, does not have to be. What would you choose to teach and why? [00:28:20] Allison London Brown: Yeah. There's a lot of things I think I would like to teach people. It's something my girlfriends and I have been talking about quite a bit lately, which is, as a woman-- and it's probably not a masterclass, it may be more of discussion group-- but it's, how do you move through those different periods of your life physically, emotionally, mentally, all of those things and still be true to yourself. And I think, I look back on my twenties and my thirties and I think "well, wow, was that really who I was? Did I have to evolve through that to get to where I am?" And if there's a way to impart any knowledge to someone to say, here are some skills you can use, here are ways to leverage your brain or deal with hormonal issues, or deal with the fact that you're having to take care of your family or whatever it is. I feel like we chunk it up a lot. We talk about, oh, mothers in the workplace, or we talk about now the big thing is menopause in the workplace, which I think is hilarious. But it's great that we're talking about all these things, but there's not a kind of path, how do you go from being an 18 year old to a 22 year old, to a 30 year old, to a whatever year old, right? So to me it's really sitting down and thinking through how do you go through each stage of your life. That would be one thing that may sound kooky, but... [00:29:50] Lindsey Dinneen: Nope. I would sign up for that Masterclass. No, I love that. And because that's not something that is really talked about and like you said, each stage is different and it brings its own unique sets of excitement and challenges and considerations and you don't really hear enough people saying, "Hey, here's some things to think about. Here's some things to watch out for." So, yep. I'm on board. [00:30:16] Allison London Brown: Yeah, I have a friend that she's in her thirties and she listens to a group of us talk and she's like, "oh, so this is what I have to look forward to." And I'm like, "oh, yes." [00:30:25] Lindsey Dinneen: Yes. Indeed. Indeed. Yeah. So, what do you wish to be remembered for after you leave this world? [00:30:35] Allison London Brown: Well, besides what we're doing here at Luminelle, I certainly would love to have that as a legacy as something that really impacted how, maybe not just how women were diagnosed, but how physicians started thinking about diagnosis differently. But, I guess I would like to be thought of as somebody who liked to have fun and laugh and brought joy to other people. [00:30:56] Lindsey Dinneen: I love that. I love that answer. That's a wonderful thing, . And then final question, what is one thing that makes you smile every time you see or think about it? [00:31:08] Allison London Brown: I probably should say my husband's face. I get points for being a good wife to say that. And it's true. It's true. It's not-- I'm not making it up. It's true. I'm a sucker for I really am a sucker for the movie "Elf." [00:31:23] Lindsey Dinneen: I love that movie. [00:31:26] Allison London Brown: I have three movies I watch every holiday, " Elf," " Scrooged" with Bill Murray and "Die Hard." And I'm not allowed to get those movies out until after Thanksgiving. [00:31:41] Lindsey Dinneen: Oh, So what works for, what works for our family is my husband and I have a tradition of always on Thanksgiving Eve, so to speak, we break bread to get it ready for stuffing so it can, kind of dry out overnight. And we spend the evening watching "Elf," and that's like the start of our holiday season. It's like a really fun tradition, do you think you could get away with that? [00:32:06] Allison London Brown: I don't know, because I will watch it like 500 times during the holidays. [00:32:12] Lindsey Dinneen: Fair enough. [00:32:13] Allison London Brown: I am a sucker for like --not stupid comedy, so I'm not, I don't like slapstick or anything like that, but I just think "Elf" is such, I mean, it's a great story. It's got great songs. It's got Will Ferrell's hilarious. It's got a great ending. It's kind of that. It's, it, I just, and I love James Kahn. Let's just, okay, sorry, but love me some James Conn. I think he's amazing. [00:32:39] Lindsey Dinneen: That is a fabulous answer. Definitely, that goes to the top of the most unique and that is so fun. I'm so glad you enjoyed that. Oh, my word, Allison, this has been such a fun conversation. I'm really inspired by what you're doing and by your focus on mission and impact and the way that you are working so diligently, even when it's tough and it's gonna be tough to share your story, to bring this to market, to change lives. [00:33:10] And we are so excited to be making a donation on your behalf Today to the Tunnel to Towers Foundation, which since 9/11 has been helping America's heroes by providing mortgage-free Homes to Gold Star and fallen first responder families with young children, and by building specially adapted smart homes for catastrophic injured veterans and first responders. They are also committed to eradicating veteran homelessness and helping America to never forget September 11th, 2001. So, thank you so much for choosing that organization to support. And we just really appreciate your time. [00:33:47] Allison London Brown: Thank you. I really appreciate it. And I hope that if one person hears this one post, one mention can sometimes change a life. And so if you're a woman out there, and if you've had abnormal uterine bleeding. That is your warning sign. And so go get checked. Don't wait. Do not pass go. Do not collect $200. Go to your physician and do not accept a subpar answer. [00:34:17] Lindsey Dinneen: Yeah. [00:34:18] Allison London Brown: So I think if I can get, just as important as it is to get physicians doing the right thing is for us to be asking for the right thing and being our own advocate. And write me a check. while y'oure at it, write me a check, I'm not sure I'm actually allowed to say that. There's probably some like SEC violation I just did. But [00:34:40] Lindsey Dinneen: Write the company a check. It's important. [00:34:42] Allison London Brown: Yes. Write the company a check if an accredited investor, please. Yes, no, I'm happy to talk to anybody who would like to know more. [00:34:51] Lindsey Dinneen: I love that. Well, thank you again. I just wish you the most continued success as you work to change lives for a better world and thank you also to everyone who has listened to this episode, and if you're feeling as inspired as I am, I would love if you would share this -episode with a colleague or two, and we will catch you next time. [00:35:11] The Leading Difference podcast is brought to you by Velentium. [00:35:17] Velentium is a contract design and manufacturing firm specializing in the development, production and post-market support of diagnostic and therapeutic active medical devices, including implantables and wearables for neuromodulation and other class three indications. [00:35:32] Velentium's core competencies include electrical design, mechanical design, embedded software, mobile apps, contract manufacturing, embedded cybersecurity, OT cybersecurity, systems engineering, human factors and usability, and automated test systems. [00:35:49] Velentium works with clients worldwide from startups seeking seed funding to established Fortune 100 companies. [00:35:56] Visit velentium.com to explore your next step in medical device development.

Joe Landolina is the co-founder and CEO of Cresilon, a biotech company that developed a plant-based gel technology to stop bleeding within seconds. Joe shares his unique journey from inventing this groundbreaking technology at the age of 17 to building a manufacturing facility in the heart of New York City. The gel, known as Vetigel, has saved numerous animal lives and recently received FDA clearance for human use. Joe discusses the challenges of building the company, the importance of community support, and his passion for helping the next generation of entrepreneurs. Guest links: https://cresilon.com/ | https://www.linkedin.com/company/cresilon/ Charity supported: ASPCA Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editor: Tim Oliphant Producer: Velentium   EPISODE TRANSCRIPT Episode 019 - Joe Landolina Joe Landolina Lindsey Dinneen: Hi, I'm Lindsey with Velentium and I'm talking with MedTech industry leaders on how they change lives for a better world. Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome to The Leading Difference podcast. I'm your host, Lindsey, and I am excited to introduce you to my guest today, Joe Landolina. Joe is the co founder and CEO of Cresilon, a Brooklyn based biotech company developing and manufacturing a plant based gel technology that stops bleeding in seconds. The revolutionary technology, which was created by Joe, recently received its first FDA clearance in human use. Well, welcome, Joe. Thank you so much for being here. I'm so excited to talk with you. Joe Landolina: Definitely, Lindsey. Thank you so much for having me on. Lindsey Dinneen: Of course. I would love if you don't mind by just starting by telling us a little bit about yourself and your background and how you ended up in medtech. Joe Landolina: Sure. So I have a bit of a unique story coming into medtech because I got a really early start. But to start from the basics, I'm a chemical engineer by training. I did both my undergrad and my graduate work at NYU in New York. I'm a New Yorker, born and raised. And my grandfather was a Hoffman LaRoche executive, that in retirement, started a vineyard. And he also learned lab safety in the sixties. And so that meant the day I learned how to walk, I was taken into a chemistry lab with my grandfather and told, "Mix some things together, don't kill yourself, kid." And so, from a very early age, I got an intro into lab research. And so that led to me inventing the technology that Cresilon was based on at the age of 17 when I was a freshman at NYU. And over the last 13 years, I've taken that passion and that invention and turned it into what Cresilon is today, which is a biotech company that has sold our products in 30 countries outside of the US. And we do all of our manufacturing and are headquartered here in Brooklyn, New York. Lindsey Dinneen: Wow. Oh my goodness. Well, first of all, the fact that you started off in a lab and we're just kind of told, "Go have fun." Okay. So what are some of your first memories of experimentation? Joe Landolina: So, I'm not sure if I can tell all of the first memories on a podcast as upstanding as this one. But what I can say is that my, my first several experiments created such fear and anger in my parents that they cut me a deal, and the deal was I had to go learn how to do lab research the right way, anywhere, please, quickly. And so, the end result of that was at the age of 13 or 14 years old, I did a summer research program at Columbia University in tissue engineering. And that program really opened my eyes up to the field of medtech, because at that time, I had a simple worldview where career paths were either doctor, lawyer, accountant, and so on. And so realizing that there were so many other shades of possibility within this industry was something that, that I realized thankfully at that age, and it started this path of really falling in love with this type of research and I dove headfirst into it. Lindsey Dinneen: Yeah, absolutely. It sounds like in general that you've had a passion for basically what you're doing now from a very young age. So how did Columbia help you narrow down this passion into a more specific area of focus? Joe Landolina: Definitely. And so let me talk a bit specifically about what I was working on at Columbia, because there was a lab there that was using plant based scaffolding. Meaning polymers that come from plant based materials to grow stem cells that come out of a human patient and have them differentiated into a target tissue. And this lab was working specifically on chondrocytes or cartilage. And so it was just amazing for me to see this material taken completely from nature that was able to be repurposed to take a patient's own stem cells and turn them back into cartilage that could potentially be put back into that same patient. And so it set me down this path where at the time I only had access to-- the internet was good for a lot of things, but not really finding information yet at that point. And so if you wanted to learn, you had to go to a library, you had to, whether it was a public library or a university library. And so I surrounded myself with Eastern medicine books, and books that looked at how pharmaceuticals derived from nature around us, because the one thing that I had, I grew up on a vineyard. And so I was able to grow anything or collect anything that I wanted to. And so I had a real interest in finding solutions to the experiments that I was trying to run in nature. And I got fairly good at identifying these sources of material, because again, no one would sell a winery lab or a 13, 14, 15, 16, 17 year old, agents to do these types of experiments. So, I had to get creative. And so that was really my entry point into that and Columbia opened my eyes that that was being done at the highest levels. Lindsey Dinneen: Wow. Okay. So nature based solutions. And as you have continued to go down this path and then of course develop your company and your products, can you tell me a little bit about the origin story of the company? Because, gosh, doing this at 17 years old, that must've been a remarkable breakthrough. I'd love to hear more about that. Joe Landolina: Sure. So, to start with, I was running this experiment in the winery lab where I was trying to make a plant based scaffold to effectively replicate some of the stuff that I had seen at Columbia. And that experiment went terribly because instead of having a multimillion dollar university funded lab, I had a winery lab, which you can interpret that as effectively a glorified kitchen counter with a bunch of equipment that was "borrowed" from Roche in the late 70s when my grandfather retired. And so it wasn't very fancy by any means. And so I didn't get the result that I wanted. But what I did get was this material that was this mess that came out of algae that would form a gel that would simply stick to skin and wouldn't let go until you wanted it to. And I had this idea, which was, what if you could take a material like that, inject it into a bullet wound, and at least plug up that bullet wound from bleeding so you can get a patient and move them from point A to point B without them bleeding out. And at around the same time, as a freshman, this was my first week of school, there was a poster in the engineering quad at NYU that said "best business plan idea $75,000 top prize." And what really drew my eye was that they would give free MBA classes to anyone who got into the quarterfinals. And I thought, you know what? There's no way I win, but I wanted to be a doctor and I was an engineer's engineer and I was really looking for things that were around me on my resume. And I thought that this stuff isn't going to work and it's not going to become a company, but I may as well join this competition. And worst case scenario, maybe I can talk my way into getting some free business classes and get me an internship over the summer. And so I met my co founder, Isaac, who was a student at the business school at NYU at the time, and we entered the competition and we ended up taking first place at the engineering school, and second place at the business school where he was at, and and the rest was history. Lindsey Dinneen: Wow. Oh my word. Well, congratulations. That's a fantastic origin story. And I love the fact that you just went into it with this mindset of, even if we don't necessarily win, we're still going to see the benefits from this other education. And I think that's so important to have a lot of cross experiences that eventually help lead into the success, and sometimes you don't see how they all interrelate, but eventually they do. I love that that's how you approached it. What a great mindset. Joe Landolina: Thank you. Lindsey Dinneen: Yeah. Well, so, okay. how many years have you been in business? Joe Landolina: 13 years later. Lindsey Dinneen: 13 years later. Okay. So 13 years later and you have now gone through several rounds of funding. And so I'm curious how that process has gone for you, 'cause that's a whole other kind of learning curve as well. How has that been for you? Joe Landolina: So we've been very unorthodox in a number of ways here at Cresilon. And the way that we raised funding was was no exception to that rule. And so we've done over a hundred million dollars in funding to date across several rounds of funding. Our first round was in 2013. So our seed run was raised from angel investors, high net worth individuals that read about us in social media. We were lucky in those early years, we had a lot of press coverage, both because of my age and really just because this technology is unlike anything else that I've seen in that you can, in a 20 second video, understand exactly what it does and what the value is. And we had this video of a steak that I cut and we pump blood through it and it's this massive bleed. You put the product on it, it stops instantly. And that video had over 140 million views on it, all in all, so we get a lot of attention in the beginning there. But then, those investors that we brought in to raise a couple million dollars in our seed round, ended up reinvesting time and time again, just all the way through the company's history, and so those same investors-- along with some other investors that we collected along the way-- ended up being the bulk of the funding that we brought in. And that's incredibly rare in this industry, especially in biotech, where there are usually different VC funds that come in at each stage, it's not like we don't have venture investing or investment here at Cresilon, but primarily our largest investors and the average investor is a private individual. And that's very rare for this type of funding, but it's allowed us to build a cohort of investors that primarily are end users. We have a number of surgeons and doctors and veterinarians who have used the product and who were very vocal in helping us design the product in the very beginning, and it allowed for this healthy conversation where if there's an investor who has money behind something, that they're not going to pull their punches when they tell us what they like. And then more importantly, what they don't like about the product. And it allowed us to get really raw, involved feedback from day one effectively. Lindsey Dinneen: Yeah. Which is so important and what an interesting funding experience you've had, like you said, it's definitely unique. Now looking back over the last 13 years: what has been one of the biggest challenges in either starting or building the company. What has been either unexpected or the largest obstacle to overcome so far? Joe Landolina: So I think that the biggest obstacle by far has been the middle phase of the business. And so when I say the middle phase, from the end of 2015 until the end of 2020. And so if we look at the business in sort of five year packets of time, from, 2010, which is when we founded the company and had the idea, to 2015, we were building a product that worked. And so at the end of 2015, we had Vetigel. We knew Vetigel would work and we were able to manufacture it. But we realized that the market demand far exceeded our ability to manufacture. And in fact, we were too reliant on third parties. And so, in 2015, the goal was to effectively outsource everything that we could. And unfortunately, when you make a highly novel product like this, we were finding that we were unable to find partners that could outsource. So in fact, there was not a single manufacturer that could manufacture Vetigel gel. We had to do everything ourselves, but there weren't even labs that could do the testing that we needed. And so we were getting false positives and false negatives. And so in 2015, we were ready to launch and I made one of the hardest decisions that I ever had to make. I pulled the plug on the whole thing. I went back to our investors and told them, "Look, if we can't do this the right way, if we can't ensure the safety of our product, we're not launching." And we raised 10 times the amount of money that we'd raised up to that point, just to build brick and mortar manufacturing. We brought in individuals who had built quality labs and done this at scale for large vaccine manufacturers. And Cresilon at that point became the very first or the very only sterile manufacturer in the five boroughs of New York, something that we're proud of. But it took us five years, and that was a very hard, onerous time where, frankly, we didn't know if it was perfectly possible or completely possible to do what we needed to do. And so the entire time we were working on perfecting, on validating, on standing up this factory where we had to design all of the equipment from scratch. Our product is like the consistency of hummus. So it's not incredibly viscous and there are lots of machines and manufacturers that make vaccines and lots of machines that manufactures and make hummus, but no one dumb enough to do it together. And so, we were lucky enough to be the first and we had to figure out a way to get it done. And so we had to design clean rooms. We were one of the first production clean rooms that had to be made in New York City under New York building code. So we had to even custom design things like sprinkler heads to comply with FDNY regulations, but also maintain the sterility of our clean rooms. And so it was literally nuts to bolts. Like every test that's run on a syringe today was designed by a Cresilon employee and something we're proud of, but it was hard. We were going effectively month to month where we couldn't sell. We couldn't make revenue until we got these pieces put together. I mean, obviously when you're doe eyed and naive, you think it's an 18 month process to stand up a factory, but it took all of five years and it culminated with launching in the very best time to launch a new product to a direct customer in an operating room, which is at the height of the COVID pandemic in October of 2020. Lindsey Dinneen: Oh, my goodness. Yeah. All those years of just waiting and planning and executing, but not, not quite being there. Oh, my word. Your patience and your stress. Good for you to have gotten through that. I would love to hear about what you consider your biggest win, but I recently read something that I wonder if we'll be on the same page here with that, but tell me what your biggest win is so far to date. Joe Landolina: So frankly, Cresilon's mission is saving life lives and the biggest win still to this date, right, it's saving our first animal life, right. I'm, my guess is that you're going to mention that the recent FDA approval for humans, but what I tell my team is it's not about the paperwork. It's not about the regulations and that's an amazing accomplishment that I don't want to minimize by any means. It's about what we do for our patients and what we do for our clinicians. And so, you know, for me, I'm an engineer by training, and so that means I'm a natural pessimist. And so I always look for flaws in products because I like to fix flaws. And the thing that you can't argue with is when you take a patient that would have not survived a procedure and translate that into a successful outcome. And we've now done that over 45,000 times on the Vetigel product line. And what I'll say is that excitement doesn't diminish. And we're now ever closer to being able to do it for the first time in a human patient. And that's something we're looking forward to. But we still have some some ways to go before we can achieve that. Lindsey Dinneen: Yeah. First of all, that's incredible how many lives you've already impacted through what you're doing. And I love your mission statement. I think you're so right to get back to the heart of it. But also I do want to say congratulations for the FDA approval, because I know that was no easy feat. That's really exciting that you're there now too. So on both ends, lots of lives being saved. Thank you for what you're doing. Joe Landolina: Yeah, thank you so much. It was a journey and a half to get to that point. It takes a lot, especially for the first time on a new technology to get it through. But I can take no credit for it, it was all my team. And they were the ones who put in the countless hours and overnights to get it done. But for now, that means we can start growing. Lindsey Dinneen: Yeah, absolutely. Is there any specific instance or memory that stands out to you as reinforcing the idea that you were in the right place at the right time? Like, this is your field, what you're doing, your specific path. Did you have a moment that was just like this affirmation of, "Yes, I'm in the right place." Joe Landolina: I'd say that's a really good question. What I'll say is that we've been very lucky throughout the entire journey. I think that the silver bullet that allowed us to stand up our factory was something that was only invented itself in the same year that we implemented it, meaning that if we had gotten there, even a year earlier after developing the technology, the thing that allowed us to solve our problems wouldn't have been there. And to get it back to, to what I was mentioning earlier, I think that there are definitely cases where surgeons that we've just trained have a case come in that day, where on a Monday, we teach them about the product and on Tuesday morning, they have a dog that's been hit by a car that would have been unsavable a couple days before without our product. And, and there are countless cases like that that we hear about and it just shows that the world keeps turning whether or not our products are out there, but the fact that we can be there and make a difference and truly save lives is something that, that just is validation enough. Lindsey Dinneen: Yeah, Oh, absolutely. Speaking about being able to use this product with animals, I noticed on LinkedIn that you seem very passionate about animals and especially shared some really heartwarming rescue stories and whatnot. So I have to ask, have you always loved animals? Is this always been a passion of yours? Joe Landolina: So I grew up on a vineyard with a bunch of property and I always joked that my parents had a menagerie at home and so we always had everything from dogs and cats to llamas and alpacas and ducks and they're interesting animals going around and and so I've always been a lover of animals. It's hard living in Brooklyn now. My wife and I recently took a plunge last year. We adopted a German shepherd puppy who very quickly grew to 85 pounds. She keeps me fit. We do 10 miles a day together. So she's adapted well to the Brooklyn lifestyle. But it's it's definitely nice to be able to do that in the city because I went for years without having a pet of my own. Lindsey Dinneen: Oh, yeah, and dogs are just such great companions. It's hard to not fall in love with them. So what's next for you and for your company and what are you excited about coming up? Joe Landolina: So on the back of this FDA clearance of of our technology, what's next is translating that into our first human life saved. And there's a lot of work that still needs to be done. We still have to scale everything up and get ready for that launch to do it the right way. But it's coming; it's scheduled for next year. And it's something that, that we're looking forward to is it just allows us to extend and expand our mission beyond what we've already been doing. And then on the Vetigel front, we've been seeing really amazing results in indications that frankly, when I came into this market, I never thought that we would be doing surgery. And so Vetigel is being used today in brain surgery, is being used in spine surgery to help dogs that were paralyzed that now can walk again because their surgery time is short enough that they're no longer at risk of of going under that procedure. And so really amazing things that are coming out of that market that we've been working with commercial partners to make sure that we're able to get that in the hands of any vet that is able to use Vetigel, or willing to use Vetigel. And so a lot of growth is ahead of us and it's just trying to put our heads down and come back to mission which is making sure that we can save lives. Lindsey Dinneen: Yeah, I love that. So is the plan to continue for both animals, and now because you'll have the opportunity to test with humans as well. So is the goal to always have both things going simultaneously? Joe Landolina: Definitely. And because we're in the human market, it doesn't mean that animal becomes an afterthought in any way. And so our team in animal health-- we have a direct sales force here in the US, the partners that we have abroad are still staying. And so we're still growing those teams pretty substantially. It just means that, for better or for worse, we have a lot of hiring to do. We have like 45 open positions right now as we start to beef up the human commercial side of our business. Lindsey Dinneen: Wow. Well, that's exciting. So anyone listening could potentially go to your website and learn more about working with y'all. Joe Landolina: Exactly. We have a careers page on Cresilon.com and if anyone interested checks that out, we have a number of roles open for for people who are interested and willing to join our team. Lindsey Dinneen: Awesome. So one thing that I noticed also on LinkedIn was I saw a couple of different posts about various speaking or resources that you seem very passionate about helping the next generation of professionals in the field to level up their skills, feel comfortable, gain the experience and the knowledge. Would you want to speak anything to that and in terms of your interest in helping the next generation? I really appreciated seeing that. Joe Landolina: Definitely. I think that I'm not the only one by far that's doing this, but it's just, founder resources are tricky because there's a level of healthy competition that happens in startups. And so something that's been very near and dear to my heart is just talking openly about sharing of resources, talking openly about mental health challenges that the founders go through, and being there for the communities that I'm a part of, and that may mean the New York community, that may mean the NYU community, or that may just be the larger entrepreneurship community as a whole, but in my opinion, this only works if the community comes together and supports one another. And I think that I've gone through this journey and there were resources that I had that were amazing, and there were resources that I didn't have, and what I'm trying to do is if there are entrepreneurs out there that don't have the same resources that I did have or that are looking for something that I also couldn't find, if I can be a little part in helping alleviate something, then I'm all for it. Lindsey Dinneen: Yeah. Yeah. Well, I love that. Thank you for paying it forward. I think that's really important and it's very encouraging to continue to see people speak out about various struggles and obstacles. And when you're real and honest and transparent with those kinds of things, you can really help somebody else who might be going through similar challenges. So thank you. I appreciate what you're doing. Joe Landolina: Definitely. Yeah, it's been a lot of fun. And in fact, I have much younger siblings. So my parents, when I was in high school, wanted to try for a daughter and ended up getting triplets, two boys and a girl. And one of the triplets who turned 18 last week has just founded his first company. And so it's it's nice to see it run in the family. Lindsey Dinneen: Oh my goodness. Yes. Congratulations. That's pretty cool. All right. Well, pivoting and just for fun, imagine someone were to offer you a million dollars to teach a masterclass on anything you want. It can be in your field or industry, but it doesn't have to be. What would you choose to teach and why? Joe Landolina: I think, negotiation would be what I talk about . Because it leans into entrepreneurship, right? And what I find is both in young entrepreneurs and in candidates that come to work for us, or members of my team, or even myself, people don't realize that the way to affect change, whether it's in, in their personal lives, in, in their work or as they're starting a company, it all comes down to how you position it and what you ask for. And so I think that it's something that people realize maybe too late on average that if you want something, all you have to do is ask for it. And one of the best learnings I had early on was that the beauty of New York is that there's so many resources just around us and at our fingertips. And if you want something, most people, their tendency is to say, "I'm going to keep that hidden. And I'm not going to, I'm not going to tell anyone else that I want this thing, but the worst you can get is 'no'." And if you ask enough people, odds are, you'll find someone who will say "yes" at the end of the day, right. And that's how we got our first lab space. That's how we got our first checks. That's how we started putting the pieces together to build the business. And so understanding how to do that is just such a great launch pad. And maybe I'm not the best professor or teacher of that in myself, but it's been a skill set that I find has helped me greatly and that people, on average, don't seem to realize that, that it's a possibility in pretty much in any circumstance. Lindsey Dinneen: Yes. Great. Great answer. And I would definitely attend that masterclass. I'm really passionate about this topic too. I think there's so much hidden power in just asking. And like you said, the worst someone can say "no". And a lot of times that "no" is "not yet". So if you've got a great idea, if you have something you need or want and you do put it out there, there are so many people that are willing to help. So yeah. I love that. What's one thing that you wish to be remembered for after you leave this world? Joe Landolina: I think that I feel bad giving the same answer, but it's true. So I so I'm going to say it again, but it's just-- if there is one patient that had their life or had a family member affected because of technology that we put out, that's enough. And so the way that I view what we do, right, I want to have made a difference in someone's life. I want to have made a product that swings the needle in, in, in the direction of good, rather than worse. Lindsey Dinneen: Yeah. And just think of all of those animals already. That alone to me is very cool as well. And this is just the beginning. So yeah, that's exciting. And final question: what is one thing that makes you smile every time you see or think about it? Joe Landolina: I'm going to say my German shepherd. Yeah. She's been a a massive positive influence in my life. So I think doing what I do, it's hard to stay grounded and stay present. And having a dog forces you to be grounded and present at least for a good part of your day. And there's something here that relies on you. And so she, she makes my day every day. Lindsey Dinneen: I love that. Well, thank you so much for joining us today, Joe. This was so much fun. I'm so excited about the work that you and your company are doing. Obviously you're making a huge difference in people's lives, you're living out your mission, and I just commend you for that. Thank you for contributing so positively to the world. We're honored to be making a donation on your behalf as a thank you for your time today to the American Society for the Prevention of Cruelty to Animals, which is dedicated to preventing animal cruelty in the United States. So thanks for picking that organization to support and we just wish you continued success as you work to change lives for a better world. Joe Landolina: Definitely. Well, thank you so much, Lindsey, for having me on. This was an absolute pleasure. Lindsey Dinneen: Wonderful. And thank you also so much to our listeners for tuning in. And if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two, and we'll catch you next time.  The Leading Difference podcast is brought to you by Velentium. Velentium is a contract design and manufacturing firm specializing in the development, production and post-market support of diagnostic and therapeutic active medical devices, including implantables and wearables for neuromodulation and other class three indications. Velentium's core competencies include electrical design, mechanical design, embedded software, mobile apps, contract manufacturing, embedded cybersecurity, OT cybersecurity, systems engineering, human factors and usability, and automated test systems. Velentium works with clients worldwide from startups seeking seed funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Rebecca Whitney is the Spine Global President for ZimVie. The episode explores Rebecca's journey into MedTech, her leadership philosophy centered around trust and mutual respect, and the profound impact of innovative spinal solutions, such as the Tether device for pediatric scoliosis. Rebecca also shares personal insights, including her love for travel and the daily ritual of morning lattes with her husband, emphasizing the importance of finding joy in everyday moments. Guest links: https://www.zimvie.com/en  Charity supported: Opportunity International  Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editor: Tim Oliphant Producer: Velentium   EPISODE TRANSCRIPT Episode 018 - Rebecca Whitney Lindsey Dinneen: Hi, I'm Lindsey with Velentium and I'm talking with MedTech industry leaders on how they change lives for a better world. Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello and welcome to the Leading Difference podcast. I'm your host Lindsey, and I am excited to introduce you to my guest today, Rebecca Whitney. Rebecca is a tenacious and passionate business leader with over 20 years of experience leading both large and small organizations in the MedTech space. As ZimVie Spine Global President, Rebecca leads a team that designs, develops, and commercializes spinal implants to treat patients with spine related disabilities. ZimVie is the market leader in motion preserving solutions for the spine, and Rebecca and her team are passionate about expanding patient access to these innovative technologies. Hello. Welcome to the show, Rebecca. I'm so glad to have you here. Rebecca Whitney: Thank you, Lindsey. I'm really looking forward to this. Lindsey Dinneen: Absolutely. I would love, if you don't mind starting off by telling us just a little bit about yourself and your background and how you got into MedTech. Rebecca Whitney: Sure. So I grew up in a suburb of Salt Lake City, Utah. I'm the oldest of three children and have always been kind of inherently pretty driven. And so what happened is, just because of my age and a bunch of AP credits, I was done with college at the University of Utah at age 20 and realized that was too young for me to jump into the workforce. And so I went straight into grad school to get an MBA. And while I was there, I took a summer internship with BD Medical that turned into a full year opportunity and it was really great. I learned a ton about product management, the medical device industry, and when I was in the final spring of my MBA, they actually offered me a full-time position. And so, I jumped right into it and didn't realize at the time just how fortunate I was to launch this career into medtech. But I've always felt very fortunate to have found a career in an industry that I enjoy so much. It's been love at first sight, and I've never left the medtech space since. So, professionally it's been just a great run. And then personally, I live in Boulder, Colorado with my husband James, and we definitely embrace a work hard, play hard approach. We love the outdoors, we love adventure travel, and are always looking to find ways to optimize our life to the fullest. So, we actually met a guy on a backpacking, hiking trip about three or four years ago in Escalante National Park. And this has always stuck with me because he said to us "Every day, do something that makes you feel more alive." And that resonated with me because we've always tried to live our life that way. And so, it's been really great. So my job is a huge part of who I am. But also I like to have as much fun as possible, as many adventures as possible when I'm not working. Lindsey Dinneen: Yeah. Oh, I love that. Yeah. Feel more alive. That's such a great way of capturing it. I've heard variations on that. One of my favorites is " do something every day that inspires your soul." I love that too, of the feel alive, because there are some days too where you might not be feeling super inspired by whatever your circumstances happened to be at the time, but the "feeling more alive" seems very attainable because you could just go out into nature if that's something you very much enjoy, or maybe you put on some of your favorite music and you just let that absorb. Okay, I'm getting carried away. But I love that. Rebecca Whitney: No, I agree. And to your point, it can be five minutes, it can be, you know, a huge adventure. But I think just that mentality, and it stuck with me, I think about it every day. So anyway, it's just a nice reminder that life is short and take advantage while we can. Lindsey Dinneen: Yeah. So looking back at growing up-- and obviously I love the fact that you dove kind of straight into the medtech world and that sounds like a happy coincidence, so to speak. But looking back, would you have ever anticipated that's a field you might end up in, or was it kind of a surprise? Rebecca Whitney: No, it was totally a surprise, a very happy, lucky one. I have always said my life and my career has followed a series of happy accidents, if you will. And so this was one of those where I was getting my MBA, I actually thought I was going to go into finance and I had interned at Merrill Lynch and so had full intentions of going down the finance path. And when I took this internship in marketing, I realized that, okay, there are a couple things about this that are really clicking for me. One, marketing brought that data and analytical elements together with the commercial and strategic elements that I love. And so I kind of found a sweet spot in product marketing at a very early age. And in the medtech space, I remember the boss that hired me, he said medical devices are recession proof. And while that's not always the case-- especially when it comes to elective surgeries in times of COVID-- for the most part, that's been true. And so, I kind of fell into the industry, but feel so very fortunate that I hopefully am helping to impact patient lives at the other end of all this. So, I never looked back and never, ever even thought about making a switch. Lindsey Dinneen: Yeah. Yeah. So what exactly does your role entail these days? How are you combining some of those interests and your passion for this particular industry? Rebecca Whitney: So what I'm doing now is I lead our global spine organization and we make and manufacture, produce spinal implants. And so we help people with back pain or related pain to any type of back or spinal cord injury. And I love the global responsibility. I can get into that a little later. But international travel has always been a passion of mine, and so being able to work internationally is just fantastic because I think it brings just a whole different perspective to healthcare and patient needs and some of those variable aspects as you work throughout the globe. And I also love leading teams, and so having this cross-functional responsibility to, to set the strategy and then mobilize the various functions and team members to get behind the strategy and execute is just really great. I've been in all different parts of medtech throughout my career. I will say that working in the spine space has been one of the most rewarding, just because you are able to see firsthand that the impact that these products are having on patients' lives and whether it's alleviating pain or getting their lifestyle back. It's just very rewarding when we hear from patients who benefits from the products and the solutions that we've been able to bring to market. Lindsey Dinneen: Yeah, I can only imagine. Are there any particular moments that stand out to you as clearly confirming that this was the right choice of industry for you? I know you're so passionate about the space and the spinal aspect in general. So I'm curious what kind of moments have you had where you thought, oh my word, I know why I'm here. Rebecca Whitney: Yeah, it's a great question and I will tell you that in this particular job, in this industry, there is a product that, that we have brought to market that is unique and it treats pediatric scoliosis. So these kids that are coming in and are needing basically to be addressed because they've got a curve in their back, the traditional standard of care is to put a bunch of rods and screws up and down their back and then fuse their spine into alignment. And while that clinically solves the problem in most instances, we have developed, an innovative way to, to basically provide the same procedure for these patients that are properly indicated. But we do it without fusing their back. And so we have this product called The Tether that we brought to market in 2019. And leading up to 2019, we partnered with thought leading surgeons, the FDA, parent advocates, and a whole slew of others to advocate to bring this technology to market. And when we hear from these kids who have had the surgery and they're back to gymnastics and cheerleading and horseback riding, skiing, snowboarding, when we hear from these kids and their parents, it is such a wonderful endorsement. And, I can't take the credit for the innovation. Those are our very talented engineers and researchers. But to know I've had a small hand and our company has had a hand in helping change the trajectory of these kids' lives, it is truly inspiring. And we bring in patients all the time to speak to our internal team members. And it just really kind of puts the context behind all the hard work, whether it's the engineers or the shipping and operations teams who are making sure the product gets to the right spot, the salespeople who are out selling it. It's just really impactful. So I would say that's probably the clearest example of every time I hear from a patient, it is just another reinforcement that I made the right choice and that there's something really special about this medical device industry when you can see how it helps patients. Lindsey Dinneen: Oh my goodness. Yes. As an adult, I'm sure that kind of an operation or procedure would be just as impactful. But I got a little choked up thinking about a child who has this condition that maybe is inhibiting their dreams of becoming a gymnast or even just as a hobby, but something that they love. And then to have that hope restored again, that's that's, immeasurable. That impact is immeasurable. Rebecca Whitney: You know, it, it really is, and I say this all the time, this is a true passion project for so many of us. And internally we have a team saying, and kind of a mantra, if you will. It's "having the courage to do things that haven't been done before." And we all kind of got behind this starting several years ago to say this is the right thing to do and we're gonna keep advocating to, to get this technology to market because no one's done it before. We were the very first. And to be able to actually see this materialize in the lives of these kids-- yeah, to your point, it's just, it's very inspiring for all of us that have worked on it and we're not gonna stop. We really are very passionate about continuing to develop this space. Lindsey Dinneen: That is wonderful. Well, I know that you are also really passionate about leadership and leading teams. I know that's an aspect of your job that is enjoyable to you. And I wonder if you wouldn't mind sharing a little bit about how you got into that leadership role and a little bit about your philosophy towards leading and managing teams. Rebecca Whitney: Yeah, so I'll start with my philosophy. I think everyone has a slightly different take on what does leadership mean to them, and to me, first of all, I've always felt very humbled and honored to be in a leadership role and I take that responsibility very seriously. As I've worked throughout my career and observed leaders, I have found that the most effective and the most admirable leaders are those that take a true interest in the individual. Because at the end of the day, we're all people, and I personally believe that the basic principles of healthy and strong relationships are the same, whether it's a sibling, a spouse, a friend, a colleague, a boss, or an employee. And so I think that you've got to start with two basic principles. For me, trust and mutual respect. And it's very important to me that I build and establish and maintain trust with the teams I lead, as well as my colleagues and my leaders. And so that's kind of number one. Those are table stakes for me. I think too, I have learned over the years that leadership does not necessarily mean being liked all the time. And early on when I was starting out, that was difficult for me to learn. And it was hard. And I remember it was about six months into my career and at Becton Dickinson, BD Medical, we'd just gone through a pretty major layoff and I was eating lunch in the cafeteria and the division president came and joined my colleague and me, which was intimidating 'cause I was fresh into the role. And he was just making conversation with us and asked how we were feeling about these layoffs that had just happened. And I said to him, "Yeah, I dunno how you do it. I can't imagine having to lay off all these people." And I'll never forget this. He looked at me and he said, "You know, you really can't call yourself a leader until you've hired and fired. You have to be able to make the tough decisions." and as a young 22 year old product manager, I remember sitting there thinking, "Wow. I can't imagine what that must feel like." But he wasn't wrong. And I think what I've learned over the years is, if you can operate with those principles of mutual trust and mutual respect, it builds up that bank account with these individual relationships that you have as a leader. And so when you have to make the tough calls and you have to make the unpopular decisions, hopefully, if you can at least help people understand the "why" behind some of these decisions. I've seen people do this really well and I've seen people do it very poorly. And I am by no means perfect at it, but I'm constantly striving to be as transparent as possible. So that people at least understand the "why." And then finally I would say, leadership is so much about creating the right environment for healthy teamwork. And so for me, I always love it when I start to see my various leaders on a team click and start to build those connection points without me in the middle of it. Because to me, that is an indicator that this team is starting to really work together in a high performing, high trust fashion. And that is the secret sauce behind every team I've ever led is creating that environment, getting the right chemistry between the various team members in the group, and then watching those connection points really take hold. To me that's where the magic happens, and I think that's what makes it all worth it. Lindsey Dinneen: Yeah. Yeah. So you've obviously had a really lovely career so far, and I'm sure will just continue. But you know, one interesting element is it sounds like you had opportunities to lead fairly young into your career, and I'm wondering how you approached perhaps teams that had a diversity in terms of ages. And was that ever intimidating to you if maybe you were coming in as a younger leader than some of your followers? Was that ever a challenge or how did you handle that? Rebecca Whitney: You know, it was, and that absolutely happened. I was probably 26 years old when I started managing people that were older than I was. And the whole team was, it wasn't just one or two. And initially I was extremely intimidated because I felt I had that imposter syndrome, you know, what right do I have? And it did take me a little bit to, to feel comfortable. I think for me, I just told myself, "Look, somebody had confidence in me and somebody put me in this role for a reason. I have to trust myself and I'm going to prove to my team through my actions and earn their trust and show that they're in good hands with me." And luckily I had a team that was very receptive, and I think when they saw how I approached it and what I brought to the table, they were very supportive. But yeah, initially I had to get over my own internal talk track that said, "You know, this doesn't make any sense. Why in the role would somebody take direction from me when I'm 10, 20, 30 years younger than they are?" But it was a great learning opportunity and frankly, it continued for, not so much now 'cause I'm a little further on in my career, but that was the case for at least the first decade of my leadership opportunities and so it was important for me to learn that early on. Lindsey Dinneen: Yeah, absolutely. As a woman leader in a field that isn't predominantly women led usually, what are some of the pros and cons you've seen? What are some of the exciting elements about that? And then what are some of the opportunities for growth as the industry continues to evolve and change over time? Rebecca Whitney: That is a great question, especially in the orthopedic spine world. It's extremely male dominated, at least historically it has been. And just like managing team members that were older than I was, I had to learn very early on that, especially when I started out, I was likely going to be one of, if not the only females in the room. And I had a boss fairly early on that, that gave me some great advice because, by default, I remember-- first of all, I have horrible handwriting. I'm probably the worst scribe you could ever pick out of a group. I've just never, ever had good penmanship and I was constantly being asked to take notes on flip charts. And I was doing it, and my male boss pulled me aside and he said, "You know, we teach people how to treat us." And he said, "I know that you're just being collaborative and helpful, but you've been taking notes for the last six times we've been in a group." He said, "The next time you're asked to take notes, say no." And that seems like a little thing, but I did, and not because I was refusing to take notes, but I just was making sure I was a little more balanced of an approach. That's a silly example. But I think that for me, I had to learn early on that there was nothing wrong with me being one of, or the only woman in a room, just like there was nothing wrong with me being on the younger side of people in the room. And again, there's that imposter syndrome. But I think having confidence in my abilities and recognizing that the more I could be comfortable in my own skin, that was what would enable me to bring probably a different and unique perspective. I was told in my twenties that I should dress in subtle tones and black and gray and navy blue suits. This was from kinda a leadership coach, and I remember thinking about that, and I thought, "I don't want to wear black and gray and navy blue suits." And so I've always tried to keep my own brand and my own authenticity while at the same time recognizing that it is difficult to kind of be the one outlier of a group. I will say that as time has gone on, I'm very pleased that the workforce is starting to better reflect our society. And I think that, that gender diversity certainly is expanding, which is nice. But my advice for anybody out there, regardless of gender or ethnicity or even just diversity of thought, is recognize that we are put into these roles because of what people see in us, our abilities and our potential. And if we stifle that in any way, shape, or form, the company and our teams and our customers are not getting what we have to offer. And I think the more comfortable I got with that, the more effective I've been able to be. Lindsey Dinneen: Oh my goodness. That is excellent advice. Really, thank you for sharing that, that really hit home. I appreciate that perspective that you've had. You've had such an opportunity to really grow in your role and I just love seeing that progression. So yeah, thank you for that advice. That was really good. I'm curious, how do you, these days, continue prioritizing your own learning and growth as a leader? Are there still things that you keep doing in order to sharpen those skills? What does it look like now for you? Rebecca Whitney: Yeah, so I'll start with something that probably is an obvious answer that most people give you. But podcasts are amazing and I'm probably a little late to the party on this because I didn't start listening to podcasts until Covid. But I have found that is a fantastic way-- I mentioned-- I live in Colorado. I will spend Saturdays and Sundays out on very long walks, either around Boulder where I live, or even up in the mountains. And I will just binge listen to podcasts on all different types of topics: leadership, business, life skills, you name it. And they're not all work oriented, but I have found that to be a really good way to just get a sampling of advice, opinion, and learnings from a wide variety of people. So that's one. And I think for me, being able to do that on the weekend, disconnect a little bit and really dig into these podcasts that I compile and save up. It, it's just it's a major reset for me in a very good way. I'm sure I drive my team crazy 'cause I'm constantly sending them these podcasts over the weekend as I listen to them as well as my family. But that's been really great for me. I would say the second major thing is, I love to travel. My husband and I look to enhance our lives any way we can, and I have found that one way that helps me learn is looking for those connection points between my personal life and my professional life. And what I mean by that is I try to be very authentic and consistent. So whether I'm in the workplace or at home with my family or on my own, the more consistent I can be is a healthier place for me, because you're not having to put on one persona versus the next. And so the more I can find those connection points, meaning if I learn something in my personal life, I can apply it into my professional life. And to me, that's where I get a lot of my continuous growth and development. So if it's tackling a big aggressive hike I haven't done before, I find myself, while I'm training for that and doing the hike, I find myself thinking about ways I can push the team at work or push myself. So strangely, as I've continued to grow in these roles and in my personal life, that balance between work and life has blurred, but I think that's been to my benefit, both personally and professionally. So I'm always looking for opportunities to enrich my personal life, because I do think that transfers back into the workforce as well. Lindsey Dinneen: Yeah. So what are you looking forward to next in terms of maybe both personally, professionally, and as your company continues to innovate and develop new things, what are you excited about these days? Rebecca Whitney: So our company, ZimVie, is relatively new. We were spun out from Zimmer Biomed, our former parent company, not even 18 months ago, and it's been really fun to help shape this new identity and this new culture. And talking about this tethering device I mentioned earlier, we have another device that allows us to treat cervical neck issues with a disc replacement which, long story short, means we're able to preserve motion for these adults who are looking to have their pain addressed. And so, what we're trying to do, and we do have a mission: we've got a number of patients that we're trying to treat in 2023 for both this cervical disc replacement device, which we call Mobi-C, as well as this tethering device for pediatric scoliosis patients. And so, what's next for us is continuing to develop these markets and make sure that we bring these amazing solutions to every patient who is indicated to receive it. And so, that's gonna keep us busy for quite some time. I'm sure we have work to do beyond that, but we're just also passionate about it. That's definitely what's next for us, at least professionally, is continuing to carry that forward. And then personally, it's always about the next adventure to, to push ourselves. So, we're actually headed to the Grand Canyon in December, my husband and I are, with my sister and brother and their spouses, and we're going to do a multi-day hike backpacking trip. So really looking forward to that and just looking forward to being outdoors with my favorite people, doing something that challenges us physically and spending a lot of good quality time together as well. Lindsey Dinneen: Oh, that sounds so exciting. Both the company's trajectory and then your upcoming adventure, that all sounds really fun. So I'm sure that will be a lot to look forward to. Rebecca Whitney: It's busy, but that's the way we like it. Lindsey Dinneen: Absolutely. Oh, I would always rather be busy than bored. Well, pivoting just for fun, imagine someone were to offer you a million dollars to teach a masterclass on anything you want. It doesn't have to be in your industry, but it could be. What would you choose to teach and why? Rebecca Whitney: So, I will say that my dream job, if I weren't doing my current dream job has always been to be a travel writer. I would love to travel the world and then write about my experiences. And so if I could do that and then teach a masterclass on it, to me that would just be the most amazing opportunity. I am driven by two things. One is influence or language and ideas. I love to communicate and I love to inspire others by speaking and sharing, whether that's talking or writing. And so to me, to share that know-how and knowledge and passion about travel-- and not just the regular beaten path, but having these adventures that are off the beaten path and the food and the culture and the people and the adventures-- I would love to, to master that and then teach people how to go tackle that so that others can share in that passion and see what the world has to offer. So, that to me just sounds like a dream come true. I would love to do that. Lindsey Dinneen: Yes. Yes. That sounds like an amazing masterclass and yes another dream job for sure. I'm just curious because I completely agree with you that in traveling internationally is such such a gift and it is so important if you can do it in terms of broadening your horizons. But I'm curious, what do you think are the main one or two things that, that you find are the most important elements of traveling abroad? Rebecca Whitney: So I would say the first thing is don't be afraid to say yes. My oldest nephew just graduated from high school and in my letter that I wrote him, as part of his graduation gift, I said, " Bias yourself towards saying yes when you're out on these trips and these adventures." And I think that when you're on an international trip, it can be really easy to just stay in your comfort zone. I'll give you an example. My brother and I were traveling in Africa several years ago and we had a driver pick us up when we landed in, where were we? It was off the coast of Tanzania. And it just happened to be the last day of Ramadan and he invited us back to his home-- we never met this man before-- to break fast after 30 days of Ramadan. And I think if we had been less open to trying new experiences, we both would've said "no way." But we said yes, and we had the most incredible experience that enriched our whole time. It was Zanzibar, that's where we were, and it was just one of the most incredible travel days of our lives. And so I think the first thing is being open to the experiences and biasing yourself towards saying yes, whether it's a dish or a food that looks terrifying to, to try. Or seeking something out that enriches the experience. I think that's one. And then two is staying flexible because travel these days, especially international, it's going to be fraught with setbacks, whether it's a train strike or a ferry schedule. So just being very flexible to kind of roll with it. Because I've seen, myself included, too many instances where some of those glitches can unfortunately ruin the experience. And so, being open to the new experiences and saying yes-- and then staying flexible to just roll with it, and take the trip as it comes, and let it go down whatever path presents itself-- I think are two really important ingredients for maximizing a global travel experience. Lindsey Dinneen: Could not agree more. Yes. Okay. What is one thing you wish to be remembered for after you leave this world? Rebecca Whitney: So this is probably a very cliche answer, but it's really true. I, I've thought about this and I do want to be remembered for the way I make people feel. And I say that because speaking about the job first, I feel like people have a choice. And any job that we take has the day-to-day tasks and requirements. But when I look back on my career, by far the most rewarding and the most challenging elements have involved people. And so I think whether it's a tough situation or a very successful celebratory situation, I want to be remembered for how I made people feel, and hopefully that's a positive thing. And that translates outside of work too: my nephews, for example, and my nieces. I want to be remembered for enriching their lives and giving them new experiences, but I also want them to know that I was there for them and the people that matter most to me. I think it's just very important. It's that old cliche saying, "people won't remember what you said, but they will remember how you made them feel." So, to me, if I'm doing my job right, inside and outside of work, hopefully people's impression after I'm gone is net positive in terms of how I made them feel. Lindsey Dinneen: Yes. And that ties right into your discussion earlier about leadership and having that bank, right? And putting in those credits and and so when things do get a little difficult sometimes you have had a net positive in the end. Rebecca Whitney: Yes. Yeah, that's right. Yes, exactly. Lindsey Dinneen: Yeah. And then final question, what is one thing that makes you smile every time you see or think about it? Rebecca Whitney: So I am a big believer that yes, we all have these milestone events and these big trips and things that come up, but I really look for the little things that bring joy on a daily basis. And when I took this role about two and a half years ago, my husband and I said, "Okay, we, we've got to find a way to stay connected because my days get busy." Even evenings are not that predictable. And so we've started getting up very early, which isn't as awful as I thought it would be. So we're typically up by about 4:30 in the morning. And one of the reasons we do this is because we have this daily ritual now where my husband makes the lattes, he's much better than I am. And we just sit together for about 30 minutes every morning. And if I'm on the road, we do it through FaceTime and it's just this dedicated little moment of time before the day gets crazy and busy where we connect, we have our coffee, we watch the sunrise and we talk. And I look forward to it when I open my eyes in the morning and throughout a busy, stressful day or trip, knowing that we have that daily touchpoint to kind of anchor with both always puts a smile on my face and it just starts the day off on the perfect tone. And I look forward to it all the time and it definitely makes me smile. Lindsey Dinneen: Yeah. Oh my goodness. That sounds like such a lovely time set aside to prioritize your relationship and get that special connection time. And of course a good latte never hurts. Rebecca Whitney: That's right. Lindsey Dinneen: That's amazing. Well, Rebecca, thank you so very much for joining us today. I really appreciate your perspective and your advice, especially for those who might be younger in leadership roles, maybe women who are coming into the medtech world, so thank you for that. And we are honored to be making a donation on your behalf as a thank you for your time today to Opportunity International, which designs, delivers and scales innovative financial solutions that helps families living in extreme poverty, build sustainable livelihoods, and access quality education for their children. So thank you for choosing that as the organization, and we just wish you the most continued success as you work to change lives for a better world. Rebecca Whitney: Thank you so much, Lindsey. I so appreciate the opportunity. Lindsey Dinneen: Yes, my absolute pleasure, and thank you also to our listeners for tuning in. And if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a friend or two and we will catch you next time.  The Leading Difference podcast is brought to you by Velentium. Velentium is a contract design and manufacturing firm specializing in the development, production and post-market support of diagnostic and therapeutic active medical devices, including implantables and wearables for neuromodulation and other class three indications. Velentium's core competencies include electrical design, mechanical design, embedded software, mobile apps, contract manufacturing, embedded cybersecurity, OT cybersecurity, systems engineering, human factors and usability, and automated test systems. Velentium works with clients worldwide from startups seeking seed funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

In this episode, Randy Armstrong at Velentium and Duane Mancini discuss innovations, breakthroughs, and challenges in IPG development and so much more. Randy Armstrong LinkedIn Velentium Website Project Medtech Website Duane Mancini LinkedIn

In this episode, Dan Purvis at Velentium and Duane Mancini discuss his background in the Medtech industry, how and why he founded Velentium, the importance of why and who, culture and so much more. Dan Purvis LinkedIn Velentium Website Project Medtech Website Duane Mancini LinkedIn

Dr. Kyle Flanigan is the co-founder and CEO of US Specialty Formulations. In this episode, Dr. Flanigan discusses the importance of providing specialized formulations that aren't typically addressed by larger pharmaceutical companies, shares about the company's focus on developing a unique oral vaccine platform called Kinder, and expresses his passion for leadership and innovation.  Guest links: https://ussfgmp.com/  Charity supported: Equal Justice Initiative  Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editor: Tim Oliphant Producer: Velentium   EPISODE TRANSCRIPT Episode 015 - Dr. Kyle Flanigan Lindsey Dinneen: Hi, I'm Lindsey with Velentium and I'm talking with MedTech industry leaders on how they change lives for a better world. Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello and welcome to the Leading Difference Podcast. I'm your host Lindsey, and I am so excited to introduce you to my guest today, Dr. Kyle Flanigan. With more than 25 years of experience, Dr. Kyle Flanigan, co-founder and CEO of US Specialty Formulations, LLC is an expert in pharmaceutical and medical performance materials development stages. He consults with companies providing robust, stable solutions and services for formulation, scale-up technology, contingency planning, supply chain issues, quality systems implementation, and new facility design. He brings this knowledge and guidance to his company's clients and their pharmaceutical and medical developments on the best path to market. Thank you so very much for being here, Kyle. I'm so excited to speak with you today. Kyle Flanigan: Yes, thanks for having me. It's a pleasure. Lindsey Dinneen: Yeah, absolutely. I would love, if you wouldn't mind starting out by telling us just a little bit about yourself and your background and how you got to where you are. Kyle Flanigan: Sure. I'm Kyle Flanigan, CEO of US Specialty Formulations. I'm a co-founder with my business partner, Gary Moorefield. The two of us founded US Specialty Formulations with the idea of being able to provide specialized formulations to the public at large. So formulations that aren't typically picked up by the larger pharmaceutical manufacturing companies. And being able to provide those to, to patients or to doctors who are treating patients with compounds and formulations that they otherwise wouldn't be able to get ahold of. And that's kinda what started US Specialty Formulations. In addition to that, both of us have deep foundational knowledge in specialty materials processing, pharmaceuticals processing, clean room operations, SOPs, setting up and building groups that work on a variety of different types of technologies like this. So we also looked at how do we further a vaccine project that my co-founder had going. And in doing that, we just, we decided to set up this company and make this service available to other people. In addition to providing just your standard formulations used to treat certain diseases out there, we also provide a service for producing investigational drugs that new inventors may come to us and ask us to make, to deliver a high quality, clean, sterile high quality product into their investigations so they can continue with their clinical trials. So that's kind of where we are. And then out of that, we developed a vaccine platform, Kinder, which is the oral vaccine platform which we just got into, we just finished up its clinical trial out of New Zealand. And we got some awesome results out of because we adapted the platform from its original intended purpose, which was strep, and into a COVID 19 targeted vaccine. And this oral vaccine actually shows improvement over the existing mRNA vaccines that are out there as far as protection capability. It operates on a slightly different regime. It's a mucosal vaccine, which is really interesting and part of a new wave of vaccines that are gonna start showing up in the next decade. And also, it's really easy to take. It's so great because this allows treatments without needing to stab someone with a needle. That's as simple as it gets. It's you don't need to have a needle to, to administer a therapeutic. Lindsey Dinneen: Wow. That is very exciting for somebody like me who hates needles. Kyle Flanigan: Yes. Both of us. I hate needles. Also, it's, that's part of the reason I got into this was to avoid-- when I was little, getting a battery of boosters and that was such an unpleasant experience. Part of the kinder thought process, and the reason we call it Kinder is because it's a "kinder" way to administer a vaccine. It's a much more pleasant patient experience. Lindsey Dinneen: Yeah, absolutely. Backing up just a little bit, you mentioned founding the company, but I would love to hear the inception story of, how did you get connected with your co-founder, and then how did you guys come up with " this is what we want to do with our careers"? Kyle Flanigan: Right. So Gary and I met through our daughters and we're in gymnastics and they're on the same gymnastics team. Anyone listening who is from a gymnastics family will know this very well. And what happens is, the person doing the gymnastics is maybe performing for a whole 30 minutes, maybe 50 minutes total time on the floor. But at a gymnastics event, typically with all the teams and everything out goes on for easily four to six hours. And so Gary had his other company that he was working with, I was employed by another company. But we were both very interested in technology . And so while we sat in the stands trying to be supportive of our daughters as they're doing these crazy death defying moves, to kind of pass the time we would just talk shop sometimes. And, over the course of a couple of seasons, we recognize that one, we got along, but two, we both had very strong and clear ideas of how to do a variety of things. So that's key. And our vision and our goals kind of align with, "Hey, if I had the ability to do this, this is what I would do and here's how I'd run it." And as we work through those casual conversations, we recognized that we were aligned in kind of our thinking of what we wanted to do with our careers. And an opportunity came up so that I was able to leave what I was doing and devote some time to some business planning, business modeling and things like that. We developed the model and then incept the business in 2013. And bring it up and just begin to build our clean rooms and things like that. We built everything by hand at first. Just the two of us again. With such intimate knowledge of the space, the operational side, as well as the development side, as well as the business side from our past lives, the two of us were able to do what typically you would expect a high powered team of, 10 to 12 people to do, just to start the company up and running. So we were able to do that, and that was, that's really what started, USSF off in this pharmaceutical space. It's really a cool story. I think our first clean room looked a little-- you could tell it was hand-built-- but it was very functional. It worked very well. Our next set of clean rooms is a lot better, and then our third set that we're still in the planning stages for our expansion, those look much more much more we'll say professionally built. Lindsey Dinneen: That's amazing. Kyle Flanigan: It was a good story because, again it's kinda like the two of us had the vision, put a business model together. And we've worked through it and surprisingly from our original business model, the environment and everything else hasn't changed all that much. So our model has held consistent through the test of time over these past what is it, 10 years? 10 years now. Lindsey Dinneen: Great. Wow. Yeah that's amazing. I love those kinds of stories where it's just a person or a couple of people with big dreams and big goals, and they just set out to do what they know that they were meant to do. And sure, sometimes it looks a little wonky at the beginning, but it works. Kyle Flanigan: Yes, we were very happy. The first formulation we had for sale was a very celebratory day. I think it was just, I think our first product was saline. We had saline for injection and it was a monumentous day when we got it packed and ready to ship to a customer. Lindsey Dinneen: Oh, yeah. I can only imagine. That's so exciting. I love those moments. So I'm curious, is there a particular moment that stands out to you because it clearly confirmed that this was the right career for you? Now, that's a broad question. So it could be related to your experience in the industry as a whole, or it could be specific to your company. But in general, is there a moment or a series of moments that just said, "yes, this is it." Kyle Flanigan: Yeah. I think, one of them actually happened fairly recently. We made an investigational drug for a customer. And they used it. And this particular one was made to enhance the survivability of organs during transplant. From that, you know, it's still in development and it's still being going through its processes. But we had to refine the formulation, develop the formulation really quickly to get it available for a-- I think they were going for a compassionate care use, I'm not entirely certain-- but you know, we were able to get the team trained and ready to go and we were able to get this formulation out the door to the customer. And we received a note later that was forwarded from their CEO to us, and it was, " Hey, you just wanna let the team know that because of your diligence and capability this, this was used and we applied it to an organ. And the surgeon let us know that the organ would not have been viable if not for the additive that you guys supplied to us and the transplant was successful because of what you provided." Otherwise, I think it was a girl of like 17 or something, she would not have made it if it, if they had not used this. I did not think it would have such a big impact in my thought process, and then after it, as it kind of sunk in what we were able to accomplish. This really is one of the satisfying things about what we do. We were able to successfully get this out. We were able to produce a high quality thing and it saved someone's life. That makes the entire team as you're going through it, it focuses you and allows you to say, "Hey, this is the goal, this is why we do this. This is why this is important." And the results are very tangible at the end. And that just affirmed that, so it was, it was awesome. But I would say that's the moment that was, you know, a couple years ago, but it let me know that, "okay, you're in the right field. This is what I like doing." You know, putting a team together that can do that. Having, the technology and the bits and parts that all come together to culminate in being able to provide that lifesaving action is really important. Lindsey Dinneen: Yeah. It is so important. And I can only imagine too, being a father yourself and realizing, you have a daughter too, and that like connection-- yeah-- of, of this is so impactful to somebody. And it could be somebody that you know personally in the future, who knows, but the point is you're making a difference. And that's-- ugh. Yeah. That's a good feeling. Kyle Flanigan: Right, it's one of the feelings-- when we thought about why does USSF exist? And that's one of the things is we handle a lot of the formulations that the big companies don't handle. For a variety of business reasons, they don't. But really, when it comes down to it, when you're a patient sick and your physician prescribed a certain medication, if that medication's not available, then it's effectively you don't have any healthcare, right? That's the problem. That's one of the reasons USSF is here, is to be able to provide, certain medications or vaccine technology, so that we are able to provide this healthcare when the larger companies have passed on providing for that. Lindsey Dinneen: Yeah. Yeah. That's great. So growing up, was medicine always of interest to you or chemical formulas or whatever, like was that always of an interest or is that something you kind of developed? Kyle Flanigan: It was always an interest. It was always, we'll say an ancillary interest. Truth be told, I'm a pilot and I love flying and anything aviation or space related. So I always wanted to go into space to do pharmaceutical research on the space station or zero G or microgravity type stuff. So , chemistry has always been a part of my training and my background. Both my parents are chemists. My dad was big pharma, my mom was analytical lab chemist, so, so it's always been there. My training is as a chemist. But I think, I always want to do from the beginning is, it's that explore and build kind of drive in me. Go into unchartered territory where I am the first, or only among the very few, that actually have blazed the way down a certain technology path or being able to introduce new things to the market. And I think that drive is one of the things that influenced my spin up into deciding to found effectively a startup, and then grow it into a much larger entity. And it's not for the faint of heart, right? As we discussed earlier, this is extraordinarily challenging. You need the technology, you need the chemistry chops, you need the science chops. But there's also more, you also need a energy and an underlying drive in order to really do this. It's that goal to explore, create, and bring people up behind me as I keep charting a path. And that's kinda the drive that's pointed me in this direction and laser focused me in this direction. Lindsey Dinneen: Absolutely. Yeah. And I love your idea that you brought up of exploring and creation and sort of being the first to go into some uncharted territory. I think that's a common theme I've noticed in this industry of people who are curious and they're interested in learning and they're interested in growing not only themselves and their own abilities, but also the industry as a whole, pushing it forward and whatnot. Kyle Flanigan: I was gonna say it's that, read everything. I think when I was growing up, the net was still-- it wasn't the net that we know now. But, reading The American Scientific or whatever business journals my dad brought home from the office. But just picking up those magazines and devouring them and reading, even though I didn't have the background in training for them, I would still read them and pick up little bits of knowledge here and there. And even today, I think one of the things that separates the kind of people on our team that do really well are those that if they don't know something or there's a meeting where there's some bit of information that they don't know offhand, the behavior that I see that really makes me proud is, they'll just go look it up. Yeah. No one goes, "Oh, I dunno," and then move on. No, you've got three or four people go look it up and like, "Oh, okay, here's what it is, now we understand it, let's proceed with this new knowledge." Those are the kinds of people that enable technology to grow rapidly because, to commercialize any technology, it's not a one man show. You might come up with certain things, but once you try to commercialize it or bring it into production or run it through a regulatory process, it becomes a major team effort, and the curious make that effort much easier than if you just have people who just do exactly what they're told all the time. That works for very large kinda sustaining type companies. But for these, the leading edge-- although as they say, the bleeding edge-- of technology, it's those kinds of people that is what's required for companies to be successful. Lindsey Dinneen: Yeah, absolutely. I'm curious how your own leadership abilities have evolved over time and how would you define leadership or what does it mean to you? Kyle Flanigan: You know, initially when we first found it, it was the two of us, then three of us, then five, and now we hover around between 13 and 16 at any given time. And I think it's gone from, initially when you first found, you're a doer, a planner, but you're focused on daily ops with a little bit of strategic stuff in there. And now it's shifted with more of a team. What has shifted is into being able to lay out a roadmap for people so that the team leaders understand where we're going. And, I'm not, and Gary's not focused on, explaining to people how to do a certain task. It's more of a "Here's where we're going, here's the task that you need to accomplish. You guys know how to do it. We've trained you how to do it, or you've got the training on how to do it now, just execute to your training, but here's where we're trying to go." So that's how it's shifted. It's shifted from the tactical to the strategic. I think for me, a leader is a person who can identify the strategic direction that the team should go. And usually that's getting input from a lot of people, not just in the company, but you know, knowing the lay of the land, right? Being out in the industry, taking in the voice of the customer, all that great stuff, and then saying, "Here's the direction this company should go. Here's what's required for us to go there, and here's what I need each of you to do to get us there." And being able to lay that out. That's kind of the strategic side. The other side as a leader is to be able to remove roadblocks from your team, meaning reading the team, how does this particular team member operate? What are their buttons? What is preventing them from accelerating and providing that feedback to them. And if it's something that you can address, addressing it. So, removing roadblocks. Again, as I say to my logistics person when he says, " We can't get this our, our supplier doesn't have this anymore." Then it's working with him and saying, "Okay, let's work through this and find some alternates and we'll work through our process for identifying alternates and picking new ones." That's a basic one, but you know, it could be as simple as, "Hey, my childcare person just quit." Right? "I have no one to babysit my child and so I can't do what we're doing." Okay, let's figure out how you can still do what I need you to do, but also your home stuff is taken care of so that you can focus, you're not worried about that while you're executing your other duties. And I think a leader has to be aware of the different challenges their team members are facing and be able to, one, create an environment to make it pleasurable to work. But two, help them overcome those different things. And so I call it just removing roadblocks, whether that's on the business side or the personal side. What are the roadblocks that I need to assist with? And sometimes you just can't do anything, right? And you have to say that. But if there's things within your power to, to help with, then I believe a leader should do that. So set the direction strategically. Empower the people to do what you're asking them to do, right? Don't tell someone to do something and then give them no power to do it or authority to do it, right? That's pretty poor leadership. And then remove any roadblocks that are coming, whether it's professional or personal, if you can help with that. Lindsey Dinneen: Yeah. That's great. Thank you so much for that advice. I think that's really important to have all those components, like you said, because people are multidimensional, so it can't just be one thing that you're trying to help manage, say. So it's not just the strategic side as a good leader, although that's extremely important. But like you said, the roadblock, I really like that analogy of helping someone to do their very best. And that could be through the work. It could be through the personal lives or whatever, but since people, it's all intertwined for us, it's so helpful to have a leader who understands that and can put it all together. So I really like your 360 approach to that for sure. Kyle Flanigan: Ah, thanks. And again, both Gary and I come from large corporate environments. So we know how not to manage people. Lindsey Dinneen: Yeah. I hear ya. Kyle Flanigan: We've both experienced that. Yeah. Lindsey Dinneen: Yep. That is sometimes not a lesson that you would prefer to learn that way, but it is a good teacher. Yeah, absolutely. Pivoting just a little bit. Just for fun, imagine someone were to offer you a million dollars to teach a masterclass on anything you want. It can be in your industry, but it doesn't have to be. What would you choose to teach and why? Kyle Flanigan: Oh, I think, yeah, for me it would be how to commercialize a product. And I say that because a lot of the world, when you hear notes about technology and the challenges associated with just being a human today, right? You'll have people say, "Oh, well someone invented X, Y, and Z." Okay. And then you have a large company, many years ago that will say, "All right, we produced 80 million of these widgets a year, and we're providing them to, to these people to make their lives better." Okay. That's two ends of a very long spectrum. Very few people are familiar with what has to happen between the person in the lab saying, "Yes, I now have a working model of what we're going to ultimately produce" to when you can go buy it on a shelf somewhere, right? And here's an example. I think, during Covid, a lot of people were saying, "Oh, we're gonna throw all this money at this problem. And we should be able to then have it go away." And it's that in between having something in the lab to having it on a shelf ready to use, that's a very long time period or a very complex period. Not necessarily long, but complex period. In some cases it is actually a fixed amount of time between certain steps in that, that have to occur, and no amount of money that you throw into it is going to speed that up. So I see this a lot in the investor discussions and other types of discussions with politicians and things where, okay, if you throw a million dollars at a given problem, it doesn't mean it's gonna be fixed tomorrow or in six months. And so teaching that class of what are the things that actually have to happen at the high level. For instance, I talked a lot about teams and building and things like that. If you were to throw up a new facility, you have to staff it. That takes time. You have to find these people. Even then, once you have the people, you have to train them on all the new equipment you put in the facility, right? So all that takes time. And that could be six months, it could be a year. The team has to get comfortable working well together, so they're probably gonna take another eight months before of actually doing it, before everyone knows what each person's supposed to do. So now you're in a, a 24 month time period from someone just throwing a lot of money at something. So, I would love to teach a, a masterclass on when we say we're gonna commercialize and start up as an entrepreneur or something like that, here's what that involves, right? Here are all the considerations that, that are gonna go into this, and these are the choices you're gonna have to make. Some, you can make early on to make your life easier on the backend. Some, you won't be able to make until the day or the month you actually have to make that decision. Some are instantaneous. But these are the kinds of things that you have to consider while going through. While I was at grad school, actually took an entrepreneur course. We used Guy Kawasaki's book. But it talks about that, that beginning cycle. How do you pick what you're gonna do? But the commercialization side, I think a lot of people who are in the field, looking at it as industry specific. But I think it could be taught a lot broader. That would be my, my thing. But how do you, commercialize looking at supply chains? We saw a perfect example of broken supply chains, right? So how do you design for those? And these concepts have been around for a long time. Certain industries are better at it than others, but it's not something that is ubiquitous in the industry. It's not a regular thought process for people. And I think in a masterclass set up, those are the things that, that if they're called out and actually focused on with a little bit more attention on stabilizing, or teaching people these considerations, it'll go a long way to mitigating those scale up risks in the future for all the other really cool inventions and technologies that are out there. But, everyone depends on a supply chain. So that's what I would teach, I would devote some serious time in examples into trying to teach people about that. Lindsey Dinneen: Yeah, that's a great subject and very important, so that would be a great class to take. What is one thing you wish to be remembered for after you leave this world? Kyle Flanigan: Yeah, again, we go back to having daughters and things like that, but as I look at them growing up and maturing, I think it's really having left the world, let's say, a better place. And by being in a better place, meaning the human condition is a lot more pleasant than it was when I entered the world. And I contributed to that. So again, vaccinations, you don't need to get stabbed every time you get vaccinated. I just hate needles. But, you know, that goes a long way at making the deliverance of healthcare process more pleasant, and making it more available to people who otherwise would not have access to it in using conventional methods. So I think that is improving the human condition considerably. And enabling a lot better care and opportunities for people throughout the world. Lindsey Dinneen: Yeah. I love that. Yeah. And I love that you're actually living what you are passionate about and so you're building your legacy as you go. So, final question. What is one thing that makes you smile every time you see or think about it? Kyle Flanigan: So many things. I'll give you two things I can't decide between them. Lindsey Dinneen: Sure. Kyle Flanigan: One is both my daughters are competitive in their sports. So one is a cyclist. And when I see her racing around the track on her bicycle, winning or placing and medaling, I am thoroughly thoroughly proud of that. And the other daughter is a gymnast, like I said. And when I see her out competing and again, medaling and things like that, I'm just immensely proud of their dedication and focus that allows them to do that. And I would say at least I married someone who was able to teach that to them probably. So I smile whenever I think of the two of them. And then drone drops, drone dropping of medications and essential supplies to the outback, places where there are no roads and things like that. I think that's just awesome. It's the combination of multiple technologies to again, improve people's lives and it's gonna be the start of something. Right now we're talking about little packages, right, for those things. But as the tech gets better and people get more and more comfortable with trusting the robots. Again, that has some science fiction implications, but I think as people get more familiar with the technology and work some of the bugs out of it, more and more things will begin to be employed that way. And it makes me smile because it is reducing the risk for people living out there and for the delivery people who have to deliver that stuff. You know, all around it's a risk reduction exercise. And it embodies everything I love about technology, aerospace, pharmaceuticals, and drones and logistics. So it's just awesome. So, I do smile when I think about drone dropping of stuff. Lindsey Dinneen: I love that. What a great answer. So relevant to what you do, but also just such a unique answer. That's fantastic. Kyle, this has been so much fun. I really appreciate you joining me today and sharing your story and your insights. So, thank you just for the time that you spent and we're honored to be making a donation on your behalf as a thank you for your time today to the Equal Justice Initiative, which provides legal representation to prisoners who may have been wrongly convicted of crimes, poor prisoners without effective representation, and others who may have been denied a fair trial. Thank you for choosing that. And again, just thank you for being here. We wish you continued success as you work to change lives for a better world. Kyle Flanigan: Okay, thank you. Thanks, Lindsey, for having me. And I appreciate it. I'm honored to always be asked to speak about various topics. Lindsey Dinneen: Absolutely. Yeah, of course. And thank you also to our listeners for tuning in, and if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two, and we will catch you next time.  The Leading Difference podcast is brought to you by Velentium. Velentium is a contract design and manufacturing firm specializing in the development, production and post-market support of diagnostic and therapeutic active medical devices, including implantables and wearables for neuromodulation and other class three indications. Velentium's core competencies include electrical design, mechanical design, embedded software, mobile apps, contract manufacturing, embedded cybersecurity, OT cybersecurity, systems engineering, human factors and usability, and automated test systems. Velentium works with clients worldwide from startups seeking seed funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

In this episode, Christopher Gates at Velentium and Duane Mancini discuss embedded cybersecurity for medical devices, the importance of addressing cybersecurity early, hackers, and so much more. Christopher Gates LinkedIn Velentium Website Project Medtech Website Duane Mancini LinkedIn

Dr. Ben Freedman and Dr. David Wu are the founder and advisor of Limax Biosciences, respectively. In this episode, they discuss their breakthrough innovation of novel biomaterials to transform healthcare, why collaboration and mentorship are so important, and how slugs inspired their work to the point of Ben being featured in a German TV show as the superhero Snail Man.  Guest links: https://www.limaxbiosciences.com/  Charity supported: Save the Children Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editor: Tim Oliphant Producer: Velentium   SHOW NOTES Episode 016 - Dr. Ben Freedman & Dr. David Wu Lindsey Dinneen: Hi, I'm Lindsey with Velentium and I'm talking with MedTech industry leaders on how they change lives for a better world. Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello and welcome to the Leading Difference Podcast. I'm your host Lindsey, and I am very excited to introduce you to my guests today. They are Dr. Ben Freedman. He is the founder of Limax Biosciences, and along with him I am honored to have Dr. David Wu, who is an advisor for Limax Biosciences. Gentlemen, thank you so very much for joining me. I am so delighted that you're here. Thank you for being here. Dr. Ben Freedman: Thanks so much for having us. It's great to speak with you today. Lindsey Dinneen: Absolutely. Dr. David Wu: Thank you for having us. Lindsey Dinneen: Yeah, absolutely. Well, I would love if you all wouldn't mind starting by sharing just a little bit about yourself, some of your background, how you got into the industry, and what you're excited about right now. Maybe we can start with Ben, and then David, I'll turn it over to you after that. Dr. Ben Freedman: That sounds great. Yeah, so for me, I was always interested in science and technology in high school and prior to that point in time, and when I was looking at opportunities for what to major in as an undergrad, I came across bio-medical engineering, which at the time was really an emerging field that kind of blended a lot of the interests that I had between medicine and engineering and technology. And I got involved with a number of different courses. Had a number of different research experiences as an undergraduate and a lot of really fantastic dedicated research mentors that really pushed me to start to explore so many different areas within the field and industry and get a sense for all the different neat and exciting activities that were going on. And I really enjoyed research at the time, in the bioengineering space that led me to do a PhD in Bioengineering at the University of Pennsylvania where I was asking a little bit more basic science questions but had really strong interest in translation, in developing new therapies. So, after that point in time, I continued to do a postdoc at Harvard and the Wyss Institute where we started kind of combining a lot of my interests from my PhD in soft tissue biomechanics with developing new therapies to try to improve the healing process. And one of those therapies that we came across very early is that we realized that for material to deliver something, whether that be a some cells or other type of drug therapy, two tissues. It really needed to be coupled to tissues locally. So we started exploring this area bioadhesive, quickly realized that this was a really exciting area, not for just areas within the orthopedic space, but really many different types of diseases throughout the body. And it basically led us to kind of explore not only the academic path, but also a lot of the translational paths as well. That's really what's brought us here today. Lindsey Dinneen: Amazing. Thank you. David? Dr. David Wu: Hi everyone. So, I am right now a clinician scientist at Harvard University and what got me interested in the space, so during high school and an earlier part of undergrad, I was really fascinated by this idea of biotechnology and the fusion between the biomedical engineering, biology, as well as healthcare. So I did my undergraduate training in anatomy and cell biology at McGill University in Montreal. And during that experience, being fascinated as a student to learn more about research, I was involved in several different aspects of research, including stem cell biology, tissue engineering and immunology. Wanted to explore a little bit more about how these things were intertwined together. At the same time, through working with the local community on certain humanitarian initiatives and community initiatives, I got exposed to the field of dental medicine actually because I was interested in having a very direct impact on each individual patient's lives, on a daily basis, as well as learning more about research and how to advance the field. As a scientist, I managed to combine both. So during my dental school at McGill University, as well, I was involved in a project in stem cell biology and regenerative medicine, looking at how we use bone marrow cell extract to help patients who have oral cancer and have undergone a radiation therapy. So as a result of these type of radiation therapy, patients would have their salivary gland destroyed, and that could lead to a lot of oral complications, including rampant caries, different types of infections, so making these patients lives very difficult. And exploring different regenerative therapies, and that introduced me to the field of tissue engineering. So, fast forward a couple of years in terms of graduation from dental school, I had the option of pursuing specialty training to become a specialist. And the specialty that I chose was the field of periodontology or periodontics. And for those of you who don't know what that entails, periodontology is basically a specialty treating gum diseases and building a good foundation of supporting structure, supporting your teeth. So your jawbone, your mandible, your gum. And right now what we do is a series of plastic surgery, a reconstructive surgery, to help patients with severe disease to build them back to a health condition to allow them to smile and chew. And part of that involves regenerative medicine and tissue engineering. So when I started at Harvard University, I had the privilege of meeting professor David Mooney, who was a world expert in tissue engineering and bio materials, and decided to start my doctoral thesis at the lab. And at the same time, that's how I met Benjamin Freedman, who was postdoc at the lab at the time, and we started collaborating on these projects, exploring the application of bio adhesives in different indications. And one of the indications we're exploring has to do with the cranial facial complex. So that kind of attracted me to the MedTech industry as well. Lindsey Dinneen: Wonderful. Yeah. And so I would love to hear then more about Limax? Dr. Ben Freedman: Yeah. A number of existing topical adhesives such as the super glues, the cyanoacrylate-based adhesives that are used commonly for superficial wound closure actually don't perform very well once you start using them in any sort of wet or actively bleeding environment that those types of glues become very rigid and don't bond well to the underlying tissue surface. A lot of existing tissue pieces are very weak. They're brittle upon any interaction with dynamically moving tissues or organs, compression, which is very common inside the body where a lot of these materials simply crumble upon any sort of mechanical stimulus that you place on them. That is coupled with a lot of the complications and challenges with the human body. There's a lot of wet tissues, a lot of tissues that are bleeding or exuding other fluids. And while these materials are really designed to try to prevent leaks and things like that, when they actually don't perform very well once they start to interact with wet surfaces. So for all these reasons they certainly demand for new materials. There's also, of course, a number of complications that have been reported for other types of bio adhesives, depending on their cross-linking mechanisms that include areas where they're toxic to underlying tissues. They can create all sorts of catastrophic embolization events and many other areas which are reported in the literature, which has really driven a big demand for developing new materials. But there's been a limitation in the field and kind of a breakthrough that we had made a number of years ago before I had started working in the lab with Dave Mooney at Harvard and the Wyss Institute. There was a discovery that was made for generating materials with really unique mechanical properties. And this was actually something that we didn't realize was gonna be as important for adhesives until recently. Because the reason why existing adhesives fail is that there's been a huge amount of efforts placed on generating strong adhesion to underlying tissue surfaces. But there has not been as big of an emphasis on generating materials that have strong cohesion such that the materials may be sticking strongly, but they have such weak matrix properties that they will fracture upon any sort of mechanical stimulus. And it turns out that you actually need really strong, cohesive properties first before you can generate really strong adhesive properties. So it turns out that a number of years ago, about 10 years ago at this point there was a discovery made at Harvard University where a new form of hydrogel was created. So hydrogel is a swollen polymer network. It's about 90% water, and It was discovered that if you created a dual interpenetrating network of two different types of polymers, one that dissipates energy and another that has high elasticity, that either one alone has relatively weak mechanical properties, but if you couple the two together, they interact synergistically to create a material with very high what we call material toughness. And these tough hydrogels have really enabled us to reimagine what we can do with a biomedical tissue. This same high toughness principle was later applied in around the year timeframe of 2016, 2017, when the bioadhesive were first developed in the Mooney group by a very talented postdoc, genuinely, who was now faculty at McGill. And this is around the time that I was starting in the lab and since then we've been working to, to create new versions within materials that have really interesting new properties, but it's really the synergistic interactions between this interpenetrating network with high toughness that's then added, coated with an adhesive layer that allows us to generate strong adhesion. And where all this came from is we were inspired by nature. We are coming from the Wyss Institute for Biologically Inspired Engineering at Harvard where we tried to turn to nature for new ideas to create new materials that have unique properties. So here we actually turned to the slug. And when slugs feel threatened, they secret a very sticky mucus that prevents 'em from being taken away by a predator. If you analyze the composition of this mucus, there's a whole series of slug slime researchers out there who have done a fantastic job quantifying some of the compositional and mechanical properties of this mucus, that it has actually very tough mechanical properties. You can stretch slug slime about 10 to 15 times its initial length without breaking, and if you analyze the composition of that same slime, it's about 90% water. It's a hydrogel, and it has a dual interpenetrating network of ions, proteins, and sugars that give it its unique mechanical properties. So, once we started realizing this, it, became clear that, hey, we have actually a material already in the lab that has really high material toughness, our tough hydrogel. Maybe we could actually couple that to tissues by applying some of the same principles of this interpenetrating network with a very amine rich bridging polymer, which we try to recapitulate in the lab. So we don't use any slug components. Full disclosure, no slug components. It's inspired by slugs and actually, Limax is Latin for "slug." So we have kept the slug theme all the way up to the creation of this entity. So it's something that we, hold very closely near and dear to our hearts. And something that we think has a really unique strategy to solve a very pressing, unmet clinical need. Lindsey Dinneen: Well that is amazing and I love the story behind it. And so I just have to ask, are you ever gonna have a snail mascot or is that a thing? Dr. Ben Freedman: That's a great question. That's a great question. But before we all laugh, we do integrate a little bit of the slug with our logo. So if you go back and look at the logo now, you'll probably notice there's a little component that does have some slug- like characteristics. And actually for fun back in 2017, a TV show based in Germany, which is essentially the Discovery Channel of Germany, came by to do a segment on our materials and they actually turned me into a snail superhero that they coined Snail Man. So, that is online someplace. But it's a fantastic snippet of what our materials can do and how they may have a, what we hope a great impact on healthcare. Lindsey Dinneen: That's amazing. I love that and I am definitely gonna have to Google that later because that's pretty fantastic. Well, I'm curious for both of you, are there any particular moments or a moment that really stands out to you as something that reinforced the idea to you that this is the right industry for you? Dr. David Wu: I think I can get started on this one. So my interest to get into the medtech industry is as a clinician, as a surgeon, you are doing a lot of surgery. You see a lot of different cases where you need a certain technology to make a treatment available to the patient in order to obtain the best results. But sometimes these treatment modalities or these technologies are not yet available. There's some maybe basic science research that demonstrated certain effects that are promising for clinical application, but in clinic, there's no such thing available. So my goal as a clinician, as a scientist, and entrepreneur is basically bridging the gap between benchtop research as well as clinic. And in order to translate this technology, I think the involvement of the medtech industry is so critical because it's a long, arduous journey to translate a basic science discovery all the way to benefit each individual patients. It involves a regulatory process. It involves manufacturing, design, marketing, so many different steps. So that was the main catalyst and my mission that drives me to not only doing these translational type of research, but also to building a strong line of, of products, of technologies to change how we treat patients and how patients benefit from these type of treatment in terms of quality of life, as well as successful outcome. Lindsey Dinneen: Yeah, that's great, Ben? Dr. Ben Freedman: And for me it was, I don't know, going back to when I was really young. When I was in fourth grade, I think I, I had a kind of this toy robot that I was trying to build and the instructions kind of had a relatively basic design of the wrist of the robot. So it was pretty much fully rigid. The hand could open and close, but it couldn't exhibit the other types of range of motion that our human wrist could have. So I added some other motors and gadgets and things like that to kind of re-engineer the wrist. I think maybe that was an early sign that I was I was going to be a bioengineer cuz I was kind of curious to innovate, curious to try to develop new solutions that could better represent the actual human condition. And through that in a number of different projects that had been going on for a number of years, well before PhD undergrad projects, early on I took a technical entrepreneurship course. Kind of got involved with what would go into a business plan relatively early, got the chance to enter some competitions very early, which were great learning experiences and kind of left me hungry for more. And I think all these experiences, have kind of added up where, I definitely wanna be an innovator. I want to inspire new scientists, train new students, and develop new solutions for really pressing unmet needs that exist. I think, talking to so many folks, clinicians in this space, having family members that have also experienced a number of these terrible diseases and disorders that there's certainly so much work that still needs to be done and not enough folks out there developing new solutions here as we're running out of time to, to do all these things. So, certainly feel kind of the time pressure to develop new and an important solutions. And really to try to think big. I think that's really the most exciting part is to have a problem and really develop a solution that can really address that, that specific problem in the best possible way. Lindsey Dinneen: Yeah. Yeah. Absolutely. So both of you have had really interesting career paths that have led you to where you are today, and it sounds like leadership has been a winding thread through various different avenues for you both. So, I'm curious, two things. One is what does leadership mean to you? And then the second thing would be what advice would you have for someone who might be interested in doing something similar to what you're doing or is looking for a leadership role within the medtech industry? So whoever would love to take that, I'd just be curious to know your thoughts. Dr. David Wu: Yeah, I can start. I think the most important part of leadership is finding a common mission and enabling people on your team to achieve that common mission together, whether it is teaching them the skills to do so or encouraging them. I think just bring everybody to achieve a same mission, the common mission, the common goal. For example, in the MedTech industry, it could be developing a new biomedical device to, to solve a particular technical or surgical issue in order to improve treatment outcome for a specific population. It could even be broader, right? Tackle aging or tackle specific type of cancer. So, having the ability to really gathering the team and to inspiring every individual team member, who are from different backgrounds, who have different priorities and different level of life experiences and skills. And how do you find the common denominator and how do you motivate them? I think that's the key to success to leadership. Dr. Ben Freedman: And I think just to add to that, there's certainly different types of leaders, different types of leadership positions, even within a single organization. I think just finding the right people that can help build that positive work environment, that can help motivate a group and inspire group to go after a common goal. And I think if you can get everybody on board with not only the mission, but but really have the drive to where it doesn't necessarily feel like work. It feels like everybody's going after something that's gonna be extremely impactful. You know, award credit when credit is due. All these things are really important characteristics of what I think goes into making somebody be a good leader. Certainly lots of things that you could learn in a class, but also a lot of it is practice and learning how to manage a lot of things going on at the same time, communicating really effectively, really recognizing accomplishments and achievements for those in the team. And being organized and focused to define goals that are within reach are all the different kind of important qualities that will go into being a successful leader. I think, we're relatively both early in our careers. So I think we're still trying to learn some of the key things here and in talking to some of our mentors about how they may handle situations and learning from others. There's always things to learn in this space to further advance our own careers. Lindsey Dinneen: Of course. And what about any advice you might have for somebody who's interested in, again, either doing something similar or obtaining a leadership role, just maybe somebody who's even earlier on in their career. What would you say to them? Dr. Ben Freedman: So, I mean, I think there's a number of things here. A number of different little key bits of advice. Certainly, people will say that you need a lot of grit, you need to work hard, you need to be determined. It's easy to say those things, but it's also, you have to practice going through those different things too, where not every day's going to be winning a competition, where there's gonna be a lot of failure. There's gonna be a lot of unanswered questions. There's gonna be a lot of things where it may not feel like you're making a huge amount of progress. You might be making a little bit of progress. You might be taking steps forward, you might be taking steps backward. But hopefully, you just have to keep your eye on the goal. And I think a lot of these skill sets with grit and determination and, not just working hard but working smart. Being really efficient with hours and time are some of the things that we've developed during this postgraduate, graduate training which, I think has been helpful probably for us as young, aspiring scientists and entrepreneurs to really have an eye on where things can go. Appreciate that it's not necessarily a straight line and things can go in all sorts of directions. But just to, try to keep a focus and we heard an analogy last night, we were at the Resolve Mass Challenge event and taking place in Boston. One of the keynotes was talking about thinking about approaching problems with kind of a bandpass filter. Filtering out the really good things and how that might affect you and the really bad. So just to keep kind of a more moderate response to a lot of the different things that are coming. And I think, part of that is true. Keep a steady pace and surround yourself with folks that, that share in your, mission and that can hear your stresses and successes and you know, just surround yourself with the people, great people and that can push you to do new things. And I think that's really an important part for folks in this industry and other industries. Where you're not doing this in a silo. I heard once that, the hardest job of somebody in these, top leadership positions, whether that be CEO or academic professors is not necessarily the company, or the lab or the whatever. It's managing your own mental health. And I think, that's certainly, an important part and something that we all have to work toward. And I think if you do that in addition to doing really good science and really good in innovative technology development, hopefully that will be something that leads to success, but it's not an easy path. It's a lot of factors that can be out of your control as well, depending on industry dynamics and people, et cetera. But until that point we're certainly in this interesting phase of great determination and surrounding ourselves with fantastic people that, that share in our vision. Lindsey Dinneen: Absolutely. David, anything to add to that? Dr. David Wu: Yes, I think one of the advice to, to any young folks either in the industry, in academia or in clinical practice is be open-minded. There's a lot of things we currently don't know. So having the foresight to network within your own industry, but also in adjacent industries. And really exploring what are the different innovations, the different discoveries going on, and how to cross pollinate and how to collaborate with each other because we have to acknowledge that we only have so much time and so much expertise in, in our domain. So having the opportunity to collaborate with people outside of our immediate field, that could be really beneficial. A second point I'd like to touch on is a mentorship. As young, aspiring leaders and inventors in the industry, entrepreneurs, it's important to seek mentorship and to learn from those veterans who have been there, done that. They have a lot of advice to share. How did they start their own journey? So by talking to these different mentors and really building your core group of mentors, or for example, there's one particular term in the literature I'd like to refer to as your "personal board advisors." So identify these people that play a certain role in your own growth, in your own development that could really expand your horizons in terms of knowledge as well as network. And the third point I'd like to touch about is dream big and also act on it. And recently, I heard somebody in my network talk about this concept. When opportunities come knocking on your door, you gotta be ready and you gotta be there to open that door. So, when you have a dream, you're not gonna be able to foresee what's gonna be coming towards you next year or the year after. But what you can do is to build a set of skill, to build a network within the industry and to understand what are some key areas of opportunity and aligning yourself up for that. And when you're presented with these opportunities, see those opportunities. Lindsey Dinneen: Absolutely. Yeah, that is great advice. Thank you very much both of you for that. I think you've touched on something that is really important and kind of a running theme of the interviews I've done so far is the concept that there are many avenues to a dream, and if you're open and you're willing to explore the opportunities that come your way, whether or not you initially thought that's how it would work out, I mean it leads people to some pretty amazing opportunities and experiences if you're willing to be open and you're willing to be humble enough to know that you're gonna be learning and growing your whole life. Well, on a different note, for both of you, just a fun question. Imagine someone were to offer you a million dollars to teach a masterclass on anything you want, doesn't have to be in your industry, but it could. What would you choose to teach and why? Dr. David Wu: If I were offered an opportunity to teach a masterclass, and this might be coming from a totally different angle, but I would teach the art of Japanese sushi and sashimi making. And part of the reason why is first, it's full of art and history. And as the culinary arts is embedded in history. There's also a lot of knowledge you need to know and a lot of training. So just out of interest, for background knowledge, a Japanese chef for a Japanese sushi chef, when they undergo through training, it takes them about three years just preparing the rice for the sushi. And that is the amount of detail, technical knowledge, repetition, and perseverance. And once they're passed onto that stage, they move on to, to teach 'em how to make it a piece of omelet or egg. And that process also takes years. So to really become a master and to hone your skill to reach that level of master sushi chef it takes, 20, 30, even 40 years. And one of the most famous chef in Japan actually is well into his eighties and still perfecting his craft. And that is an analogy to my specialty, which is periodontal surgery. We do a lot of plastic surgery and a lot of the techniques in plastic surgery is very refined. You need to have fine control of the surgical blade. You need to master different levels and tiers of techniques. So that's kind of in parallel to, to the art of sushi making. So if I was offered a million dollars, I will definitely teach a class on these different aspects. Lindsey Dinneen: I love it. Ben? Dr. Ben Freedman: Yeah. So before I was-- I guess in parallel, actually, while I was doing science, I had a side job of teaching sailing. I grew up doing some water sports and got really passionate about teaching sailing and not just competitive sailboat racing, but I just loved the whole concept of working with somebody that's never been on the water, may have just learned how to swim and teaching them an entirely different skillset. It's not necessarily like walking or riding a bike, it's something where there's a lot of controls. You're on a boat that's floating and, and the ocean, there's lines to pull, there's ways you have to maintain your balance. All these things that, that go into place so that the boat goes forward, doesn't go in circles and you don't flip the thing over. And I've had such an enjoyable time working with younger students, adults. I volunteered for a number of years for the Sailing Special Olympics, working with athletes of all different backgrounds that, I would, in a heartbeat, love to build a, a whole career out of sailing. Probably not even pay me to do it. I would, certainly do it for free just because it's been such a strong passion of mine over the years. I think there's a lot of similarities to sailing a boat and doing a lot of things in life, whether that be entrepreneurship or learning a new skill or working harder in a class or doing a PhD, et cetera. A lot of times with sailing, it's not like driving a motor boat where you can go from point A to point B, you have to zigzag through the wind. You have waves, you have unintended obstacles that you'll hit, and you have to sometimes adapt on the fly. You can't predict what the weather is going to be or what might be out on the water. And I think that certainly resonates closely with me and the different activities that I'm doing in academia and the industry. And something which I think is true for a lot of us in life. So, without a doubt, I would teach a masterclass in sailing and I would do it for free. Lindsey Dinneen: Well, we could put the million dollars towards your business. How about that? Dr. Ben Freedman: Sounds good. Lindsey Dinneen: Or a cause that you care about? One of the two. Dr. Ben Freedman: Perfect. Lindsey Dinneen: Oh, amazing. That is awesome. Thank you both for that. What is one thing that you wish to be remembered for after you leave this world? Dr. Ben Freedman: I think certainly, we're in this area because we certainly wanna make a difference and we don't wanna necessarily have any regrets of not going after something that could be, a chance to improve healthcare, improve our environment, improve world peace, et cetera. So, I think that we wanna be remembered as or at least I want be remembered as something that goes after challenging problems that are facing the world, going after them in ways that are, of course ethical and, creating a great community and, and group along the way. I'm also really passionate about training folks and enabling them to be successful at whatever they do and solve other really important pressing problems that we're facing. Hoping to make a mark in many different areas I'm gonna hopefully be remembered for those things and hopefully they do result in some new novel device. But if they don't, the way that we're going about it, just wanting to do that in the best possible way that enables others to have a great impact on the world. Dr. David Wu: And as for me in terms of one thing I wanna be remembered for, as a clinician and a scientist, and I teach a lot students along the way, and I had a lot of mentors who have played this role in my life. I want to be remembered as somebody who really encouraged people to pursue their dreams and provided them with concrete advice, resources, and opportunities so they can find a fulfilling career-- whether it is in the medtech industry developing new devices to help patients, or whether it is to become a scientist to advance their research project or become becoming a clinicians to treat patients-- to help these trainees and students find the ideal career path and the ideal sense of fulfillment for themselves. So as a mentor and as a leader, that's one thing I wanna be remembered for. Lindsey Dinneen: Yeah. Those are great answers. Thank you. And then my final question is, what is one thing that makes you smile every time you see or think about it? Dr. Ben Freedman: Oh, right now the number one thing that makes me smile-- we just had a our first child a few months ago. And seeing our baby smiling or crying makes me smile every single time. Lindsey Dinneen: Aw, congratulations. That's wonderful. Dr. David Wu: And for me, also in terms of you were talking about personal milestones. So this past summer I just got married to my wife. We've been dating for almost 11 years now. So it's a long time coming. And just being able to spend time together, whether talking about our future or going on new adventures, exploring different parts of the world, that's something that makes me smile. Lindsey Dinneen: Those are great answers. Well and clearly, great reasons to smile, so I'm so glad to hear about those things. Dr. David Wu: I'm smiling right now. Lindsey Dinneen: I love it. Well, I just wanna thank you both so, so very much for your time today. We are very honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational and safe environment. I am truly inspired by what you all are doing and the different solutions that you are developing for a whole variety of different uses. And thank you for your passion and your drive to change lives for a better world. I just wish you both massive, continued success as you go along your paths, and thank you, thank you for being here. And thank you so much to our listeners for tuning in and if you're feeling as inspired as I am right now, I love it if you'd share this episode with a colleague or two and we will catch you next time.  The Leading Difference podcast is brought to you by Velentium. Velentium is a contract design and manufacturing firm specializing in the development, production and post-market support of diagnostic and therapeutic active medical devices, including implantables and wearables for neuromodulation and other class three indications. Velentium's core competencies include electrical design, mechanical design, embedded software, mobile apps, contract manufacturing, embedded cybersecurity, OT cybersecurity, systems engineering, human factors and usability, and automated test systems. Velentium works with clients worldwide from startups seeking seed funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Haven Tyler is a Senior Client Relations Executive in medical device development at Boston Engineering and an aspiring interior designer in her spare time. In this episode, she discusses her innate curiosity about the world, why she decided to focus primarily on the medtech industry, her passion for furthering women's health, the power of mentorship, and the time she starred in a horror film. Guest links: https://www.boston-engineering.com/industries/medical/ | https://www.linkedin.com/in/haventyler/ Charity supported: Polaris Project Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editor: Tim Oliphant Producer: Velentium   SHOW NOTES Episode 015 - Haven Tyler Lindsey Dinneen: Hi, I'm Lindsey with Velentium and I'm talking with MedTech industry leaders on how they change lives for a better world. Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello and welcome to The Leading Difference podcast. I'm your host Lindsey, and I'm excited to introduce you to my guest today, Haven Tyler. Haven is a senior client relations executive at Boston Engineering, a consulting and technology development firm based in Boston. Haven brings over 30 years of a consulting experience to her clients and she has worked with such consulting firms as IDEO and Continuum. Haven appreciates the variety in her work, especially the broad range of technical business and regulatory challenges her clients face. In her varied career she made the personal professional shift eight years ago to focus on medical device development because of the impact her teams have on improving patients' lives. The path her current role has not been traditional. Haven has a BA from Sarah Lawrence College, studied history of art and fashion, and is an aspiring interior designer in her spare time. Along the way, she also had a short-lived acting career and starred in a horror film in her senior year in college. What knits it all together is an innate curiosity in the world around her and solving tough problems. Well, hello, Haven. Thank you so very much for joining us today. I am so excited to learn more about you. Thanks for being here. Haven Tyler: Oh, Lindsey, thank you for inviting me. I'm excited to go through this with you. Lindsey Dinneen: Yeah, absolutely. Well, I was wondering if you wouldn't mind starting by just telling us a little bit about yourself and your background and maybe how you got into the industry. Haven Tyler: Oh, sure, I'd be happy to. So I have to say, in perfect honesty and transparency, my path to where I am has not been a straight one. So it's quite varied. I started out by going to college in New York. I went to a small liberal arts school called Sarah Lawrence. And I studied art history actually. But I think that the thing that education, and also in my family, that was instilled was the sort of innate sense of curiosity. So I think that's a thread that runs throughout my career. I ended up in the Boston area and started actually working for an industrial design firm and learned about industrial design, which is something that was totally new for me. So I'm clearly more of a visual sort of design person, but I've appreciated the sort of messiness of the creative process and the complexity of problems and I've really always loved that kind of, there's a problem and everyone's brainstorming and coming up to a solution as a group. So that's always been something that I've really enjoyed and I learned a lot from an industrial design perspective. And I was really lucky I got to work at some pretty amazing places. I was able to work at IDEO as their Head of Business Development on the East coast in what I would consider the halcyon days, if you will, of design and design thinking and innovation. And, you know, a lot of those words are buzzwords now, but we were actually living them, you know, back in the day. And that was just such an exciting sort of heady time . And it really just opened up my eyes to how our work could make a difference in the world. And at that point I was professionally focusing on a range of products including consumer products as well as some medical. But then during the course of basically 30 years, at some point, maybe about eight or nine years ago, I had reached a sort of apex in my career and in my life and just really thinking about what my-- "legacy" is a big word and it's not exactly how I was thinking about it. I don't know what the correct word is, but I was thinking about what difference I could make in the world. And that's when I made the professional and personal decision to shift to focus just on developing medical devices. And at Boston Engineering, I've been able to do that, which has just been a great privilege to be on the team. And I've loved the complexities of the problems we face and our clients face on a daily basis. I have things that come across my desk that are fascinating and they're disease states that you didn't know about, and understanding about that and sort of diving into what those patients experience, what the doctor's experience, what the hospital's experience in terms of purchasing equipment, what our clients experience in terms of their business needs and their regulatory hurdles and reimbursement hurdles, and the challenges are really complex. And that's what I love is cuz then you have lots of different people with lots of different areas of expertise contributing. I hope that helps answer the question. That was a long-winded, long-winded answer, I apologize. Lindsey Dinneen: No, I love it. I love that your story is not linear and that you have so many different really interesting twists and turns in your path. I think that's really exciting. And then, I really appreciated the sort of theme of curiosity is being what kind of ties it all together and I'm sure keeps you interested and motivated every day. Haven Tyler: It does. And you know, it's interesting because in preparation for this, I've been thinking about how I ended up where I am. And I grew up in an academic family in New Haven, Connecticut, and my parents were-- their upbringing, they were born after World War II, so it was like forties and fifties. So their upbringing was very strict and restricted. And then when it came to their own children, it was the seventies and the eighties, so it was hands off parenting. It was very different than it is today. But it was also explore your bliss, like find your passion. There was never a sense of you're gonna have to pay the rent or have a career. There was no thing involved. Lindsey Dinneen: So, so that was a wonderful thing growing up and maybe a slightly rude awakening as an adult, or were you prepared? Haven Tyler: Well I think I was prepared in the sense that they instilled a sense of, "you can figure it out." You have the tools to figure anything out, no matter what it is. And it was a question of perseverance and grit and, all of those things. So, I think that it was definitely a little bit of a rude awakening, but you could figure your way out of it. Lindsey Dinneen: That's fair. I think no matter how prepared you think you are, you're not, anyway, you know, it's always a learning curve, but that's what keeps life interesting. Haven Tyler: Exactly. Yeah. It's interesting too because I love the fact that if you had asked me at 20 or 21, when I was graduating school, where do you think you'd be? This is not what I would've predicted at all. And I'm also grateful for that because I've ended up in a place that's really great and I, I couldn't have made that up. I couldn't have fantasized that. So, I think that the fact that I get to go to work every day and feel like possibly I'm being helpful to the planet or the world, and maybe we can make a difference in people's lives. And I work for a company that has a ton of integrity and they believe that, they really do. It's not just some kind of byline. It's something that the whole group lives and breathes and that's pretty incredible to be able to say that, right? So, I feel lucky to have landed in a place that feels authentic, you know? Lindsey Dinneen: Yes. I completely agree. That's one of my very favorite parts about being in the industry is knowing that even if your role is a little bit on the fringes, perhaps it's not the actual engineering of the product, but you're still helping to talk about the product and introduce it to the world, or however you fit into it, you're still making a difference. And I think that's a really powerful motivator and makes it fun to come to work every day because you just know inherently that you're doing good. So that's really special. Haven Tyler: It is special and I don't think everybody gets to say that, you know? And I have friends who do a variety of different things and I have friends I've known since I was a kid and they're scratching their head going, "you do what for who," you know? How did you get there? And I was like, "I know it doesn't really make a ton of sense, but it's really where I should be." And I don't know if everyone gets to say that. Lindsey Dinneen: Yeah. It's a special situation when you do, for sure. And especially if you've been through other seasons of your life when perhaps you didn't feel quite as connected to what you were doing. All work is valuable, but sometimes, your personal connection, if it's not there, makes it a little bit harder to be excited about getting up every day and going to work. Haven Tyler: Yeah. And there was a large part of my career where there was a a focus on really sexy products, if you will. But they were more based in the consumer realm. I loved being a part of that. And it was really cool. And it definitely had its attractions. But at the end of the day, I was like, I'll be walking down the aisle in Target or whatever with my kids going, "Yeah, I helped make that," and I just, I don't know, it wasn't moving the needle or helping the way I wanted to help. So I think that kind of spurred me on to look at medical a little bit more closely. Lindsey Dinneen: Yeah, absolutely. Is there a particular moment or series of moments that stand out to you because it clearly confirmed that this was the right next career choice for you? Haven Tyler: Yeah, I think you're right-- the word "series" is probably the best. It's a lifetime of experience, and I can say this now cause I'm getting towards the tail end of my career. I had some health concerns in my own family that we had to address and I think my gratitude for the help that we got living in the Boston area-- I mean-- how fortunate are we to live in that area? You know? So I have access to some of the best minds and medical community. And I grew up in a medically privileged environment. My stepfather is a medical doctor. And our pediatrician was Uncle Sid and Uncle Sid would just like come on over to the house, and it was just amazing that you had access like that. And anyway, my, my appreciation and my gratitude for the people who are helping me and helping my family through a couple of different medical things was really profound, and it gave me a new line of sight into how complex that world was and how complex it was to get to the point where you were able to receive that kinda help. So I think that was definitely an aspect of things. I think that also having certain people put into my life. So certainly working with my colleague, Paul O'Connor, who heads the medical business unit at Boston Engineering, that has been a really wonderful partnership, and I appreciate working with him. And he's, he has much more experience and depth in the medical arena than I do. But I think that we have a skillset that really complements each other and I rely heavily on him for aspects of building our business. And I hope that, I hope the inverse is true. So, I think, having a combination of those types of things. I think one thing I wish that I had, and this is something that I talk to my own children about, is finding a mentor. And I didn't have that. So everything I did was really either sort of self-guided and I was just following my curiosity. Or something got put in front of me, and maybe it was fate, maybe it was, who knows? Something was in front of me. I think that large part of that was the product of my upbringing, of the sort of "follow your passion" kind of thing versus the " I'm trying to find a different kind of balance for my own children" and thinking about it with them as they're embarking on their careers. And maybe there could be a little bit more planning involved than there was in my career. Yeah, so I think the value of having mentors in your life, professional mentors, is something that could really be a great tool. Lindsey Dinneen: Yeah. Oh, a hundred percent agree. And that brings me to-- I'd love to hear some of your advice for perhaps somebody who is interested in coming into the medtech field. Maybe as a, either a young career person who would be interested in growing into a leadership role or somebody who is switching careers. Is there any advice that you would relate to that person to help them as they begin that process? Haven Tyler: Yeah, I think, the notion of a mentor is really the strongest drum I would beat in that regard. I may not also be the best person to ask that question just because I've always been on the consulting side of things. I have not been a part of a larger corporation, like a big med device firm. So I don't really have that perspective necessarily. I do know what I hear at conferences. I do think, and I'm gonna really stress this, that we need more women. I think that the more women we can have in medtech leadership, the better. I've been going to a number of conferences and doing my own research and women's health has been sorely underrepresented for a long time. I think we're getting slightly better and I think we're talking about women's health in a different kind of way, which is fantastic. But the numbers of research and development dollars that are spent globally on women's health is very low. I mean, I think the percentage is about 2%, which somebody said at a conference is a rounding error. I would love to see that change with the next wave of leadership and I would love to see more women writing checks and making those decisions to expand those conversations and learn more about the different phases of women's health that we go through cuz there are topics that we talk about and there are topics we don't, and I think there's been a decent amount of conversation around women's health, particularly around childbearing years. But, the topic of, let's just say menopause, is one that's very complicated and I think it's a potentially huge market. So from a business perspective, I think big companies should perk up about that. But I think we need to know more because I think that we don't know enough about that. It's not necessarily a disease state, if you will, but there are lots of varied symptoms with that phase of life and it can be quite confusing. So, I'd love to see that improve. So I guess, mentorship. If you're a younger person, maybe be a little bit more strategic with the help of someone who can guide you through so that you can attain the goals that you, you want to achieve. Lindsey Dinneen: Yeah, absolutely. Mentorship is such a wonderful gift when you find a good match and are able to learn from that person and benefit basically from their own experiences and things that they would've done differently looking back or whatnot. You know, you talked a little bit about how-- because you didn't have a mentor-- you were self-taught and self-motivated or whatnot. And I'm curious: you have such a interesting eclectic background and you've had lots of different experiences. So how do you personally prioritize your own continued learning and growing, cuz obviously that's just been part of your life along with your curiosity, but I'm just curious how you prioritize it. Haven Tyler: Oh, it's such a funny question because it's, it's not even a question of prioritization. It just happens. I'm just a curious person. I mean, I'm constantly taking classes that may have nothing to do with my professional life. I think I mentioned I'm pursuing a certificate in interior design because I like it. It's just interesting to me. Color and how colors relate to each other, and color theory. I go down these little rabbit holes that I think are very interesting and I go from there. I love architecture, I love gardening. It's never a dull moment, unfortunately for my family. But yeah, I mean, it's always been that way. It's definitely fun. So I know a little bit about a lot of things which I think has actually served me well in my particular role, because my role at Boston Engineering is to identify where opportunities might be, develop the appropriate program, and I get engineers to help me with that. And that's creative in a way 'cause if you're looking for an opportunity, I'm looking for the negative space, right? I'm looking for where the hole is and, can I go in there and, is there a problem there we can help solve? And so, as I said, it's messy, but it, it ends up being not messy once you find the solution, if that makes any sense. So no, I don't really have any sort of prioritization. The one thing that I have gotten better at though is, and I think Covid taught us all a lot, but it's just personally that I've gotten better at is boundaries. So, I start my workday at a specific time. I end my workday at a specific time. And so that allows me to have the space to do the other things I get curious about. So, during Covid, I personally found it a little hard because I think like a lot of us, there was a lot of fear. We didn't know what was coming around the corner from a health perspective, from an economic perspective. It was just scary for everybody. And so I was just very driven. And I think that while it's great to be driven, it can also be unhealthy. So, yeah. Lindsey Dinneen: I'm just chuckling because I relate to that so much. Haven Tyler: Yeah, exactly. And you can burn out and burnout's not good. I have a 18 year old who is going to be a college freshman, and she's incredibly driven. And she's just a good student. I've never had to check her homework. I've never had to do anything. And she can burn out. And I, I see this cycle in her and I think she's getting much better at having a balance, but I think left to her own instincts, that's where she goes. And so while that's a great thing in a lot of ways, how do you temper that, so, yeah. Lindsey Dinneen: Yeah. And that is a really hard balance. But like you said, trying to put in some specific boundaries really does help. It sounds like you are boxing yourself in, but it's actually a freedom generating exercise. Haven Tyler: Absolutely. I do think that one of the things that I've learned over life is that because I have three children and I, I've been a single parent for most of my children's lives, and taking care of myself was something that I didn't do very well for a long time. And making that a priority is really important. And that can come in many different forms. That can come with, I need to get enough sleep, I need to drink enough water, I need to exercise, I need to make time to walk the dog or sit outside in the woods or whatever it is that I need to do, to be able to do everything else effectively. It's like that analogy where they give you the instructions on the airplane. And it never made sense to me that you would put the air mask on yourself first before the child. And I always thought that was just the complete opposite. I was like, "this is crazy." And then the reality is no, if you can't breathe, you can't take care of your child. So if you're a crazy person and you haven't slept and you're not eating well and you're not exercising, then you're not gonna be able to take care of anyone else. So, that's been something that has been a priority for a number of years for me. And like finding those balances and saying to people who need my time, like, "Yes, I really want to talk to you. That is very important. I have to get back to you in an hour." Or whatever that is. " But I can't have that conversation right now. I want to have that conversation, but let's do it in a little bit." And creating those guardrails has been helpful. Lindsey Dinneen: Yeah. Yeah, that makes a lot of sense. Yeah. And not to pivot too dramatically, but I really do have to ask you about your short-lived acting career. Okay. First of all, how did this even come about? And second of all, what was that experience like? Haven Tyler: Yeah. So it's, it was a little surreal, but yes. So I, as a part of my schooling, I took my senior year in Italy for art history. It was just an amazing experience. And that's one thing I encourage everyone to do. Try and study abroad if you can, or live abroad for a little bit. Anyway, while I was there, I was doing a lot of, and I had been doing while I was in school in New York, a bunch of kind of modeling and that was a great way to make money, but it was painfully boring. So I wanted to get out of that, but I still needed to figure out a way to support myself. So, an American woman, who I met in Rome through a friend, was a casting agent, and she said, "You know, let me send you on a few things." And she sent me on one audition and it was funny because my mother, who is a dean of a college at Yale, she's like a serious person. She had flown in, we were gonna spend two weeks together and she had flown in and I said, "Oh, before we go, I have to go on this audition." And she is looking at me with her blue eyes going, "What the heck is this?" And I said "No, no, no, it's fine." And we went into this place that kinda looked like a dentist office, but it had these big posters with monsters. And these guys come out and they don't speak any English and they say, "Come with me." And so I go back there and all I had to do was scream. So my poor mother was waiting in the lobby and all she hears is me scream. And so, I got the part. But I think that largely had to do with the fact that I had red hair and freckles and Sigourney Weaver was a thing at the time and the movie was a very specific genre. It was sort of a mashup, which was common then. It was a mashup between sort of "Aliens" and "Terminator." Anyway, it was just an absolute blast. I'm so grateful I had the experience. I am a horrible actress. But it was just really fun. And we spent two months filming in abandoned nuclear power plants. We spent a week in Venice filming overnight. I mean, it was just incredible. Lindsey Dinneen: Yeah. Oh my gosh. Thank you for sharing about that, because that is an amazing story and such a unique opportunity. I love that you did that. Haven Tyler: It was very fun. And I think two years ago, it was the 30th anniversary or something of the film release, and it has this unusual kind of, but very fun, cult following cuz it's this bad, bad horror movies. It was a part of a big drive-in movie theater movie festival up in upstate New York. So we all went, my family all went, we had our beach chairs and we got to watch it. And we had posters and signing autographs. It was just, it was very funny. Lindsey Dinneen: That is amazing. I love it. I love it. Well, okay. That is fantastic. Just for fun, imagine someone were to offer you a million dollars to teach a masterclass on anything you want. It can be in your industry or related to your education, but doesn't have to be. What would you choose to teach and why? Haven Tyler: That's a really fun question, and it's a big question. I think it would be a combination of teaching people to be their authentic self, and curiosity and creativity, all jumbled up together. And how to explore those and find them in yourself. Lindsey Dinneen: Yeah. So when you say finding your authentic self, is there a specific thing that you would highlight? Or how would you talk more about that? Because I think that's an important thing that, that isn't always talked about as much. Haven Tyler: Yeah, I think that I'm fortunate to have landed in a place professionally where I feel comfortable being myself. I think that when you're starting out your career, there's this feeling that you might misstep or you might make a mistake, and you clam up, you don't speak up, because you are concerned that you might say something wrong or you might embarrass yourself. Or you know, I mean, and I was guilty of this too. I'm not saying this with any judgment. I just think that it's, it's a natural thing. But to encourage people to feel, especially younger folks, to feel more confident in sharing because like 99.9% of the time us old folks in the room, we wanna hear what you have to say. But to let go of that fear to allow yourself to, to shine, whatever the topic is. Lindsey Dinneen: Yeah, absolutely. Yeah. And I think that's especially something-- in fact, I was just having a conversation about this yesterday of the tendency and I think-- maybe not all women, but a lot of times for women-- especially the tendency to shrink and not show up as your full, authentic self. Not because you don't want to, but because you're not sure if you're gonna be accepted or if your opinion's gonna matter or count or any of those things that, that kind of keep you a little bit more quiet when actually you have a voice. You have things to say. And your contribution matters. Haven Tyler: Yeah, it absolutely matters. And I've had the privilege of having younger folks on our teams and having these conversations with them and then once they start to feel encouraged and more supported, the solutions and the things that the ideas they have are just fantastic, really great stuff. And I see this with my own children as well. I love talking to my adult children. I'm like, "Wow, that's really interesting that you thought about it that way." Or they'll know something profoundly different than I do. And I think it's fascinating. So I would encourage people to find a place where you feel safe enough to be able to express yourself that way. Lindsey Dinneen: Yeah, and I absolutely agree with you. And conversely, I think that's a good reminder also for leaders to, to provide that space, to provide that encouragement for especially younger folks to speak up and that it's safe, it's accepted. So kind of on both sides, like yes, encourage the younger career folks to, to speak up more and also encourage those who do have the privilege of being in leadership to do their part to foster that environment too? Haven Tyler: Absolutely. And I think it's our responsibility to do that, actually. Lindsey Dinneen: Yeah. Well, you know, you mentioned legacy a little bit earlier and that ties in very well to one of my questions, and that is, what is the one thing you wish to be remembered for after you leave this world? Haven Tyler: So again, a very big question. I think I would really appreciate if people could think of it as like, "Oh, she was helpful." I don't need to be a rock star. I don't need to be a shining star. I just wanna be helpful. Lindsey Dinneen: Yeah. Love that. Yeah. And then final question, what is one thing that makes you smile every time you see or think about it? Haven Tyler: Oh, my dog. A hundred percent. Lindsey Dinneen: Okay. Tell us about your dog, because I love dogs. Haven Tyler: No, she's a total punk. I love her dearly but she hates people except for us. And she's just, yeah she's wonderful, little cuddle bug. But she's a Boston Terrier, but she's sort of the wrong colors. They're normally black and white and she's brown and white, and so she's a little offbeat, which makes me like her even more. Lindsey Dinneen: I love it. She is her own dog. Haven Tyler: Exactly. Lindsey Dinneen: That's fantastic. Well, I love hearing your stories and your insights and your advice. Thank you just so very much for taking the time today to speak with me and for sharing just a little bit about yourself and what's important to you. I just really value that. So, so thank you. Haven Tyler: Thank you, Lindsey. I appreciate this, and I appreciate before we jumped on the recording, you describing your motivation for starting this podcast. And I think that it's really important the work that you're doing, and I think that getting at the underlying motivations for people being in this industry is really interesting. I mean, yes, at the end of the day, it is a business and we do live in a capitalistic society. I mean, that's just like baseline. However, within that there's a lot of choice that people have to make, and how you go about achieving those goals can be very different. And I think that on our side of the fence, on the consulting side of the world, none of us are ever going to be the next Bill Gates. But it's such a motivator to think that, " Okay, this might make a difference in somebody's life." And it just gives me goosebumps to think about, like that we can say we helped make that. It's really pretty cool stuff, so I'm glad to talk about it. Lindsey Dinneen: Yeah, absolutely. Well, we are honored to be making a donation on your behalf as a thank you for your time today to the Polaris Project, which is a non-governmental organization that works to combat and prevent sex and labor trafficking in North America. So thank you for choosing that organization to support and really appreciate that, and we just wish you continued success as you work to change lives for a better world. Haven Tyler: Thank you so much, Lindsey. Lindsey Dinneen: Absolutely. And thank you also to our listeners for tuning in ,and if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two, and we will catch you next time.  The Leading Difference podcast is brought to you by Velentium. Velentium is a contract design and manufacturing firm specializing in the development, production and post-market support of diagnostic and therapeutic active medical devices, including implantables and wearables for neuromodulation and other class three indications. Velentium's core competencies include electrical design, mechanical design, embedded software, mobile apps, contract manufacturing, embedded cybersecurity, OT cybersecurity, systems engineering, human factors and usability, and automated test systems. Velentium works with clients worldwide from startups seeking seed funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Alex Condon is the COO and co-founder of Galen Data. In this episode, he discusses how his background working with small businesses prepared him to grow and scale Galen Data, why he occasionally looks outside of the medtech industry to gain inspiration and insight, and how showing up and being a good person will write your legacy for you. Guest links: http://www.galendata.com Charity supported: Opportunity International  Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editor: Tim Oliphant Producer: Velentium   SHOW TRANSCRIPT Episode 014 - Alex Condon Lindsey Dinneen: Hi, I'm Lindsey with Velentium and I'm talking with MedTech industry leaders on how they change lives for a better world. Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello and welcome to The Leading Difference podcast. I'm your host Lindsey, and I'm excited to introduce you to my guest today, Alex Condon. Alex is the COO and co-founder of Galen Data, a medical device cloud data platform. Prior to starting Galen, Alex was the Chief Strategy Officer at Tietronix Software, a longtime NASA contractor. Alex is originally from Scottsdale, Arizona, having attended Arizona State University, but now calls Houston home. Thank you so much for being here today, Alex. I am so excited that you're here and talking with me and welcome! Alex Condon: No, thank you for the opportunity, Lindsey. Sincerely appreciate it. Lindsey Dinneen: Absolutely. Well, if you don't mind starting off by just telling us a little bit about yourself and your background and maybe how you got into the medtech industry, I'd love to start there. Alex Condon: Sure. So I'm originally from Scottsdale, Arizona. That's where I grew up. I went to school at the WP Carey School of Business at Arizona State University for finance. So something way outside of MedTech. When I was 19, I got hired at a private investment management firm that was there in Phoenix and worked there until I was about 27. And then parted ways and took a job at NASA, Johnson Space Center, working for a NASA contractor, Tietronix software. They've been around for a long time. I usually focused on advanced technology across a wide spectrum of use cases. Things from system modeling and system engineering, all the way to augmented reality and blockchain applications and things like this. And one of the things that a lot of NASA related kind of space flight software companies do down in Houston where offices is, is they moonlight doing medical device software because the compliance rigor of NASA space flight software is very close to class three medical device. So, the NASA contractor was splitting maybe 50% NASA related work and 50% custom medical software. And from that we saw a pattern merge of companies that needed cloud connectivity as part of their medical device offering. And typically if you're going to engage in that kind of work, it tends to be very costly and take a lot of time to develop. But the requirements from project to project are very similar. Everyone needs a way of seeing their device data, showing it to stakeholders, whether that be patients or clinicians or maybe someone else in the value chain. They needed a way to run algorithms, create notifications against the data. And from there we saw the opportunity to create a product and that's where Galen Data got started. So, went from finance to working with a NASA contractor and now in MedTech. Lindsey Dinneen: Wow. Oh my goodness. Yeah. So you have had quite the exciting background. When you first started, could you have imagined that you would be now a COO of a company that you helped get off the ground from the very beginning? I mean, was that ever an idea of yours or was this just a complete surprise? Alex Condon: I've always worked for small companies. When I worked for the investment management firm, I was the first employee, it was a team of three. And then when I left, I wanna say we were somewhere north of about 30. I think that number sounds right. When I started working for the NASA contractor, they'd always been small by design, liking to take on projects that they could really dedicate a lot of time and focus to. And it was about, I wanna say 75 people. And when I entered, I was in a Director of Strategic Initiatives role, and then moved up into Director of Strategy role. So, always worked for small companies. When the opportunity to create Galen rolled around, it felt very comfortable. So, no real surprises. But the journey itself was the surprise. Lindsey Dinneen: Right. Getting from point A to point B was the surprise. Very nice. Is there a particular moment that stands out to you that this was the right career for you specifically? It could be Galen Data specific, but just in general working within the medtech industry, are there any moments or a series of moments that stand out to you as just, "Yes, I'm in the right place?" Alex Condon: I think that the product was launched out of a need that we saw out in the world. So I think that being able to analyze the gap and seeing that these medtech companies were having to take on a large burden when it came to their cloud software. So those companies would have to, like I said, put up a lot of money, a lot of time, but there's an operation side of kind of owning cloud infrastructure and medical device that a lot of them might not be able to wrap their heads around. So when you have the software, that can connect your device to the cloud, you're responsible for all the data that ingests, so you're responsible for all of the privacy concerns, the regulatory concerns. On the IT side, you're responsible for things like cybersecurity. You're responsible for things like disaster recovery. And in all of those landscapes, things change all the time. There's new regulations. There's new cybersecurity threats and all of those things can tend to morph a medtech company into an IT company. And that seemed like kind of a growing risk concentration, especially as more medical devices started leveraging the cloud for whatever they needed. So, seeing that gap and seeing that the team we put together the CEO, Chris DuPont, the CTO of Abbas Dhilawala, both of 'em have very deep industry experience and by the work we'd done together, working at the NASA contractor, we all came out of the same place. I believe the team had the ability to execute. So if you marry that idea of product that has a need could seriously help people get their device to market in a safe and de-risked way, and then also have the team to execute on it, that to me solidified this is something that I wanna do and I think that it benefits the greater good. Lindsey Dinneen: Yeah, absolutely. So could you tell me a little bit about the history of starting the company and where you are now and where you're looking to be? I'm always curious of the evolution of a small business and how you can go from that very first idea to reality and beyond. Alex Condon: So, Abbas Dhilawala, our CTO, had the idea of creating this platform. Chris DuPont, our CEO, he has always had an entrepreneurial bent, and so they both latched on this idea of this is something that they want to do. But there was no kind of execution arm to get it done. And that's when I entered in. So, far before we became an actual company. But this idea of, well, Alex has this background in helping companies grow and seeing how a company should come together at an early stage. So putting some kind of, some meat on the bones. From then, we registered the company. The name, Galen Data, it doesn't really mean anything and it was by design. We knew that it was going to be in medical device or healthcare. So we picked an ancient Greek physician, Galen, to tack onto the name and then data, because we knew we were gonna have big data in some respect. Took those ideas, made the name, and then when the product came around it seemed to fit fairly seamlessly: a medical device cloud product for kind of cloud data management. So Abbas had the idea and then a lot of it existed in his head. So from the time that we started the company in terms of kind of filing all the documents, we raised some funding and then Abbas just hunkered down and it went radio silent for a long time pouring his evenings into making an MVP for us. And from then it was okay, now we have this product, now it's time to try to scale it a bit. So we brought in a VP of IT Ops and started trying to attract some kind of initial clients. And when you have a company like ours that's housing a lot of this medical device data and the medical device companies who are our clients are reliant on our ability to execute, our ability to persist as a company, you have to knock on a lot of doors to find early adopters. As a small company that's being entrusted with a huge piece of operational infrastructure for a medical device that might have raised tens of millions of dollars and employ dozens of people, it requires a tremendous amount of trust. And one of the things that's not lost on me is the amount of trust that those early clients put in us. The idea was relatively new to the space. Connectivity as a platform idea was something relatively new. Prior to that, everything was like what we were doing, kind of built the spoke. So, I look back and I love all of our initial clients, do anything for them. But awed by the amount of risk they took on working with a startup. And actually, one of the greatest days of Galen's existence was when we finally looked at the books and realized that we could persist through time. And that you were making enough money to pay all the bills and it was a huge sigh of relief across the company. And that is a, a great day that I'll always remember. Lindsey Dinneen: That is a great day. Oh I love hearing those stories because I know how hard it is to get a company up and running and to be profitable and actually viable. So, so kudos to you because that is no small feat. So I am curious, you come from a finance background and found your way into the medtech space, which I think is fantastic. Do you have advice for others who might be in a similar situation, come from a background that is different, maybe not engineering, but that might be interested in being a part of the industry? Do you have any advice for those kinds of folks who might wanna make that leap? Alex Condon: I think that this is a small industry that is very welcoming. And they put a lot of emphasis on knowledge. And so I think that if you are looking at becoming a leader in the medtech space, understand where your niche is, right? Go deep in that area. Network. People will respect you for the depth of knowledge you have and whatever it is you choose to pursue. And I think that's an easy way of integrating into the greater ecosystem. I think that the medtech in general, it spans so many different facets, right? From the people who are going out there and creating the product or the scientists behind the reason for the products to exist all the way through things like quality, regulatory, in our case, software supply chain, all of these different things. And I think that as long as you can show that you know your stuff in where you fit in the greater big picture, that people will naturally gravitate towards you. And I think that if people naturally gravitate towards you, it's also a good sign of trust and I think that, you know, if you have trust and you have people who believe in you, that's what kind of takes you places in this industry. Lindsey Dinneen: Yeah. That is really a great perspective, and I think that you're completely right in terms of, when you know your own area of expertise, it doesn't have to be the same as anyone else's. In fact, it's helpful to have a bunch of complementary skillsets. And you're right, I think this is a very welcoming, it's very respectful industry and sort of allowing each person to have their own area and own it and people are really friendly here. Alex Condon: Agreed. And I think that it's one of those-- the kind of the beauty of the space is that, everybody is aligned towards inevitably the goal of helping people. Even if you work in some aspect of supply chain and you're far removed from maybe the doctor with an idea, everyone is moving in that same direction. And I think that when you have all of those people paddling the same direction, not only do you rely on each other, but you can also create a lot of momentum. And I think that momentum has a pervasive way of working into people and bringing people together. Lindsey Dinneen: Yeah, absolutely. And you mentioned at the very beginning of answering that question, that knowledge is such an important component, and I couldn't agree with you more. And I'm curious how you as a leader in this space, and as somebody who has had a couple different iterations of your career so far, how do you prioritize your own learning and growing as a leader, as a individual, as a contributor to this field? Alex Condon: So I think that again, kind of knowledge in the space being important. I always try to focus on, be the best that I can be in the space that I'm in, right? So we probably work right now with 20% of large companies, 80% kind of startup companies, and so understanding the value that we add in both places. Always trying to stay on top of new happenings that would affect either our company or kind of the state of the industry, both from the big company kind of perspective and also from the small company perspective. And always trying to take time to also study things on the periphery, right? How we can improve as a company. How I can be a better part of the greater team. And really keep the focus there. And I think that a lot of my job also is going out and talking to different folks in both places, the small companies, the big companies, and trying to be an active listener. And understand what their pain points are. Pain points can evolve over time. And they're usually unique to each individual conversation, right? And then try to take those things and formulate them in a way that I can then better my own learning by turning actionable, right? Where are my gaps by listening to the outside world and trying to chase after that information or that answer, or try to seek out that key opinion leader or something like that who might be able to add more to to the story that I can ingest and then put into practice. Lindsey Dinneen: Yeah. Great answer. I also think, sometimes it's helpful to look beyond your own industry's standards when it comes to any aspect of the business and to sometimes look at other industries and see how they're being successful in various ways and see if you can't grab some of those ideas and make them your own. And I'm curious if that's ever happened for you too, where you can get stuck in, "Oh, this is how everyone in the industry does it." But there's a lot of great resources outside too that can sometimes apply. Alex Condon: Sure. Absolutely. I think that we are a SaaS product, right? Software as a service. And there isn't a lot of that in the medtech space, right? You have some quality management system companies that are doing things, maybe you have some supply chain platforms and things like this. But medical device in general has been a laggard when it comes to adopting new technology on the operational level. So when we first entered, you had to look around and see other areas where connectivity was more widespread. So, when I was looking at how my piece of Galen would form itself, I looked at the Internet of Things space. So looking at how companies had been successful in connecting devices in energy or in consumer devices in the home and things like that. And seeing how we could turn those ideas and those success stories and try to make them a part of our narrative with a MedTech flavor. And it's been interesting. The perspective that you get today is based off a lot of success stories, right? So right now, when you look at how other people were successful, you have to remember that it's winners biased, right? You don't hear about the mistakes that companies made that no longer exist, right? And in our case, we were bringing a product that was new to the market. This idea of cloud data management for medical devices, a very compliance heavy industry, wasn't something that a lot of people had kinda pursued wholeheartedly. There might have been some fleeting attempts but not enough documentation to make something useful. So, looked in those areas and tried specifically to find why people failed. And why is it that some of these companies that were hot in the connected device industry didn't make a mark? And then also I think that goes back to your question about kind of understanding your industry. Why, if at all, is MedTech different, right? And it is. The product life cycle is so long. The funding cycles for the startup companies, the decision cycles for the large companies. In both instances, the slightest hiccup can throw you off for months. So being able to appreciate the buying cycle, work it into kind of a greater business plan. And then making sure that we had realistic expectations heading into it was something that I think was critical that we learned as a result of both knowing our space, but also looking out and seeing where other people had success in aligned areas like IoT. Lindsey Dinneen: Yeah. Yeah. That's great perspective and I really appreciate you sharing about that because, just in terms of what you were saying regarding winner's bias and things like that, where we have a tendency, even from an outside perspective, to only look at the wins or to only hear about the wins, right? And so I think it's really helpful to also be able to have those honest and transparent conversations, when appropriate, to say, "Yeah, we tried this and it flopped, and here's why. And that's okay cuz we learn from it." Alex Condon: Absolutely. And I think that to your point about transparency, that's probably one of the most core pieces about Galen Data everywhere that I've ever worked has been a very transparent and flat kind of organization. And that's very much the culture that we have with Galen Data. Try to value everybody's opinion, always make them feel like they're a part of the team. Always allow ourselves to be open to criticism, even if it's from the lowest person on the org chart all the way up. And always think about the feedback that we get. And like you said, approaching problems with kind of introspection and brutal honesty. Lindsey Dinneen: Yeah, that's just been a reoccurring theme that I, I keep hearing from folks that I've been talking to is that idea of curiosity being such an important component to not only your own personal learning and growth and whatnot, but also as an organization. And if you can stay curious, then you can stay teachable and you can stay humble too, actually, which is not a bad thing. Alex Condon: No, I think that I kind of find myself to be a naturally curious person. And I think that everything amazes me. I'm one of those people. I have a million interests. Everything amazes me. And I think that if you can bring that to a job or to a company, whatever, that it'll really take you places because you get out of your own kind of mental trench, right? It's important to pop up and look around every once in a while. And I think just being a naturally curious person creates that naturally. If that makes sense. Lindsey Dinneen: Absolutely. I will say, when you were talking about popping up and looking around for a minute, I had this instant vision of this meerkat, so we can have our meerkat moment, you know, where we pop up and look around... Alex Condon: That is a perfect example. I'm a huge outdoorsy person and one of my favorite things to do is just go out and look at Prairie Dog Towns. And so, sometimes you're digging and you're digging and digging in the dark, and every once in a while it's important to pop up and see what's going on around you. Lindsey Dinneen: I love it. Oh my gosh, that's amazing. Well, okay, pivoting just for fun. Imagine someone were to offer you a million dollars to teach a masterclass on anything you want. It can be about something in your industry, but it doesn't have to be. What would you choose to teach and why? Alex Condon: So I grew up-- my family, me, mom, my dad, and my sister-- we did road trips a lot to the national parks. And I've always been, like I mentioned, a huge fan of the outdoors. And so I think that if I were to teach a masterclass on anything, it would probably be maybe national parks and kind of conservation in general. And this is not just something that's talking about here domestically in the US, but you know, national parks exist everywhere and every national park has a narrative around it. And I think that also, the outdoors kind of needs to fit inside of that work-life balance. And so for me, one of the things that I'm passionate about, and I try to do as often as I can, is go see the national parks, get some fresh air, take in the beauty that's around us and try to exist in that moment. Try to kind of take things in for the wonder that they are before you go back to work or family life and things like that. So, I love telling or reading about the narratives behind some of the big national parks here, hearing stories about the ones that are overseas, and I think that if I can share that passion with other people and get them more outdoors and enjoying that side of life, that's something that I would do if I had my druthers. Lindsey Dinneen: Yeah. Oh, I love that. And that would be a great masterclass because it seems like not a lot of people necessarily prioritize as much, but when you've had the privilege to grow up and visit those places and experience what it's like to be in nature, and like you said, just take a moment and slow down and just be present. That is so important. So yeah, I would attend that masterclass. Alex Condon: Sure. No, absolutely. Knowing a bit about your travels, I'm sure that you feel the same. It's, it's an important part of of our short time here. And so, make the most out of it. See all the things, do all the cool stuff. Try to soak in as much as you can and at the same time, if you're passionate about something like I am about Galen Data, you can have your cake and eat it too. Lindsey Dinneen: Yes. Amen to that. Well, what's one thing you wish to be remembered for after you leave this world? Alex Condon: So this is not something that I think about too often. I think that, it would be great to be remembered by friends and family as just a good person. Again, I have a lot of interests and when you extrapolate out, if I could take my experience in the business world, or maybe socially, and apply them to all these various interests that you have, there's probably a narrative that gets left as a residual if you're able to pursue those paths, right? And so I think that if you show up and treat people well, the legacy will write itself. And in our case, one thing that's not lost on me is our product, it's a great accelerant when it comes to medical devices coming to market. And when I think of medical devices-- we'll take a startup perspective-- there's a lot of education, a lot of late night working, investor money, time spent, creating these medical device products. And if we can help those companies get to where they need to go in a de-risked way, maybe they come to market far faster, that means that their impact can be by more people, right? More people sooner who need these kinds of products. So in that vein, we're a small piece of the puzzle. But our kind of legacy I guess would probably live on through the devices that we service, right? So that's one thing that's extremely gratifying about the role, right? We have many devices, devices on four continents, dozens and dozens and dozens of companies that are using us. Being a piece of that narrative, even if the champion is the inventor, happy to carry them on our shoulders as best we can. And at the end of the day, we'll never really have an idea of the number of people that we help. But it's satisfying to know that we've been a piece of the process for so many device companies. Lindsey Dinneen: Yes. Absolutely. Couldn't agree more. That's fantastic. And final question, what is one thing that makes you smile every time you see or think about it? Alex Condon: I laugh as I say it because a lot of it has been talking through it with you is, how we end up where we are, right? So, from working in Phoenix, Arizona, and essentially a basement with two founders of a investment management firm, and grinding my teeth there for years. And then, working with astronauts as part of this NASA contractor and getting to meet a whole lot of interesting people. And now being surrounded by some of the brightest people in the medtech space. I'm always happy to be the dumbest guy in the room. And looking at that play out in your own life is something that I smile about. And then, outside of that, for me again, hearing positive feedback from the companies that we help, where they tell me something that was tangible to them: "we were able to save this much time, money or whatever we were able to launch our product this much quicker," or something like that. Going back to the last answer, hearing the results of your work. Again, being able to pop up from being that prairie dog digging in the ground and looking around and hearing people have liked what you've put a lot of sweat equity into and hearing how it really helped 'em, that always brings a smile to face a hundred percent of the time. Lindsey Dinneen: Yes. Oh yeah. That's a great answer. Well, thank you so very much for joining us, Alex. We are honored to be making a donation on your behalf as a thank you for your time today to Opportunity International, which designs, delivers, and skills innovative financial solutions that help families living in extreme poverty build sustainable livelihoods and access quality education for their children. So, we appreciate you picking that organization to support and thank you again so very much for your time today and we just wish you continued success as you and Galen Data work to change lives for a better world. Alex Condon: Thank you so much for having me. Yeah, I sincerely appreciated it. Lindsey Dinneen: Oh, absolutely. Thank you also to our listeners for tuning in and if you're feeling as inspired as I am right now, I'd love it if you share this episode with a colleague or two and we will catch you next time.  The Leading Difference podcast is brought to you by Velentium. Velentium is a contract design and manufacturing firm specializing in the development, production and post-market support of diagnostic and therapeutic active medical devices, including implantables and wearables for neuromodulation and other class three indications. Velentium's core competencies include electrical design, mechanical design, embedded software, mobile apps, contract manufacturing, embedded cybersecurity, OT cybersecurity, systems engineering, human factors and usability, and automated test systems. Velentium works with clients worldwide from startups seeking seed funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Kevin Saem is a brand leader at Zapyrus, a lifelong learner, and a passionate problem solver. In this episode, he shares stories from his early childhood in Cambodia and how that inspired his interest in medtech and healthcare, why he's so passionate about creating impact wherever he goes, and why he places a high value on curiosity.  Guest links: https://www.linkedin.com/in/kevin-saem/ | https://welcome.zapyrus.com/ Charity supported: Save the Children Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editor: Tim Oliphant Producer: Velentium   SHOW TRANSCRIPT Episode 013 - Kevin Saem Lindsey Dinneen: Hi, I'm Lindsey with Velentium and I'm talking with MedTech industry leaders on how they change lives for a better world. Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello and welcome to The Leading Difference Podcast. I'm your host, Lindsey, and I am so excited to introduce you to my guest today, Kevin Saem. Kevin is a brand leader at Zapyrus, a lifelong learner, and a passionate problem solver. Having lived in Asia, North America and Europe, Kevin is a leader that values diversity and believes that the small differences are what give intrinsic value to an individual. Kevin, thank you so very much for being here. I'm just so excited to have you here and learn all about your background and what you're up to these days. Kevin Saem: No problem, Lindsey. It's a pleasure to be here. Thanks for having me. Lindsey Dinneen: Of course. I would love starting off by just sharing a little bit about your background. I know that, even from your bio, you have had such a cool life so far, all sorts of places that you've lived, and I'd just love to hear a little bit about that and maybe what brought you to where you are today. Kevin Saem: Yeah, absolutely. How far do you wanna go back? Lindsey Dinneen: Whatever would make sense in terms of inspiring you to do what you're doing now. Kevin Saem: Yeah, absolutely. When I look back right in my life, I always think of it as like the movie Inception. I don't know, have you, if you've seen Inception? Lindsey Dinneen: I love that movie, one of my favorites. Kevin Saem: So it's like a, yeah, so it's like a dream within a dream. When I look back at my life, cuz I grew up in a third world country. I grew up in Cambodia and it's almost like a different life there. So I almost see like a life within a life when I made the transition over to Canada. I was born in Cambodia, lived there for 10 years, lived through the nineties. And during the nineties, Cambodia experienced a couple things. So in the early days in the seventies, eighties, we experienced the Khmer Rouge, the genocide which my parents and my grandparents lived through. And then right outta that, when I was growing up in the nineties, we experienced the HIV/AIDS epidemic, which was a delayed onset from what North Americans experienced in the eighties. And so because of the whole genocide and internal warfare, the country was in already recovery while being compounded with a healthcare crisis, right? Super chaotic. Hospitals were not a thing at the time. There were like some, and I lived in the Capitol, and just seeing people that you knew, like neighbors or friends and family be affected by this disease. And nobody kind of knew what was going on until the UN stepped in and brought some aid and support through portable kind of diagnostic testing for this disease, which kind of helped brought the spread down and help control the spread of the disease. And seeing that impact of what healthcare technology, especially in the MedTech space, diagnostic specifically, could do to a small population in a third world country like that really stuck with me from the early days. So when I moved to Canada in 2000, started studying here, really gravitated to the STEM field. So science engineering, was able to put my thinking cap on in that space, so to speak. So I went to university and studied chemistry. I went in with a life science background and then specialized in chemistry and decided to go to grad school and do my PhD in chemistry and infectious diseases specifically for diagnostics and medical devices, for testing of infectious diseases because I had that in the back of my mind growing up in Cambodia and seeing the impact that those technologies could make. And I'm a firm believer in chasing impact and creating value at every stage of your life. Like within your inner circle, what value you could create before you move on, what long lasting impact that you could create. So from Cambodia to Canada to my graduate days I was fortunate enough to meet a bunch of intelligent people, be taken in by very talented researchers in the space. I did my studies in McMaster University, which has now become, I believe, the most research intensive university in Canada, if I'm not mistaken, a few years back. So I studied under professor Jose Moran-Mirabal and I had a bunch of other professors as mentors, and they were really great. I was able to touch a lot of different topics in research, which is unconventional from a graduate experience. Usually you're narrowed down into kind of one scope, but I was able to start with kind of material science, materials engineering, like making novel, conductive, stretchable, elastic materials. Moved from there to nanotechnology, biosensing, and then eventually closed off my graduate degree in doing some work on premature 3D printing and tissue engineering work to create synthetic scaffolds for testing or biomimicry, which that work has been able to mature over time. So that's like my graduate experience. So when I was, I would say in the last year of my graduate study, again going back to the impact theme. I wanted to understand, what was the next step after a research paper. Like how do you go beyond just benchtop work into actually creating a product that could affect people's lives on a day-to-day? And I wasn't able to get that just being in research. And so that got me thinking about the startup path going into industry, you know, the typical challenges you come across as you're nearing your graduation, right? What is the next step? Do I pursue a career in academia, become a lifelong researcher, and just stick in that space? Or do I take a step out and look at the rest of the world and see what other cool things people are doing? So putting on my curiosity cap again. Got a chance to network when I was doing a sabbatical research with my professor at the time, Dr. Jose Moran-Mirabal. He had a sabbatical in the south of France and he took me along. It was really great experience, right? We had a lot of great wine, traveled everywhere. So again, unconventional, I would say, graduate experience. So I was very lucky to have had all those sorts of experiences. And it was like a France/Canada collaborative research internship where we were starting kind of new project in tissue engineering and really novel biomaterials, right? And this was like at the very start of the early days of 3D printing for medical devices. And so, got a chance to meet a bunch of cool people. And then one professor that sponsored us there started this liquid biopsy startup company out of the institute that we were working in. And so nearing my graduation, I was presented with an opportunity to be a part of that early day kind of startup life or this novel liquid biopsy startup company that was in the south of France. And so, I spent a bit of my time there again, wearing multiple hats, helping raise capital, managing R&D strategy, managing relationships with industry. So I did that for a little bit of time and got to know the medical device system from an OEM's perspective at an early stage and then the pandemic hit and it threw a wrench in everybody's plan, not just my own. And so at that time, our Prime Minister gave out a signal to all foreign workers to come back home. So I had to come back home and it was another reset. And I was looking at kind of new opportunities in the space and I stumbled upon this local Toronto bootstrap SaaS company. At the time it was called Zymewire and I did a little bit of digging and found that it was bootstrapped by a couple of guys. The CEO, Pete Bastedo, he came from the pharmaceutical side of the business. And then the co-founder Ryan, the CTO, he had a technical background. So I was really fascinated by this kind of bootstrap company model. And I took a look at their site and fell in love with the culture that they represented. And it aligned really closely with the philosophy that I had as well. And so that got me even more interested and took me down a rabbit hole of like, all right, what are they about? And so, I made the connection between Pete, the CEO, and a good friend of mine that came out of the same graduate program. And I pinged my friend Faheem. I was like, "do you know anything about this guy, Pete? How is he?" And then he gave me nothing but great reviews on Pete. He's a really intelligent guy, really smart, and he's doing cool, exciting things with the company, right? And so, eventually ended up speaking with both Pete and Ryan and they were telling me about their plans for the company and kinda where they wanna go. And given kinda my background in MedTech, they wanted to expand the product offerings beyond Biopharma and into MedTech. And that's how I came about into Zymewire at the time. But now we recently rebranded to Lumerate. And now Zapyrus was born just last year around this time as a premium MedTech business intelligence tool specifically for the MedTech industry. And so now we have that. Now it's real. Lindsey Dinneen: Wow. Oh my gosh. That is amazing. First of all, your story is incredible. Thank you for sharing all of that, and it's so fascinating to me to learn about how someone's background and often childhood can really shape who they end up becoming. But it's interesting because for a lot of the guests that I've had so far, there's been something that says, " I wanna make a difference in this area." But then their career trajectory and their education has allowed them to sort of weave in and out of all sorts of avenues of pursuing their dreams in very interesting ways. So I just love hearing about that. So thank you so much for sharing and I would love to hear a little bit more about your company and how it helps MedTech companies now. Kevin Saem: Yeah, absolutely. The industry is made up mainly of these small players. I would say 80, 85% of MedTech companies are small, medium size businesses, and then they eventually get acquired by the big ones, right? Basically, our platform helps to connect MedTech service providers with MedTech OEMs at the right stage and at the right time so that they can be supported to bring their lifesaving technology to market. And as you know, a lot of medical device companies come from maybe a doctor had an idea, right, that there's this unmet need and they need this device to come to market, but they don't have any business background or they don't know how to get device to market. And so there's a lot of mess that goes into the early days that a lot of service providers can't help these companies and get this medical technology to market and actually affect people's lives in a positive way. And so for us, we wanted to humanize business development. We were seeing a trend where there's all these solutions that would give you lists of companies, lists of contacts, and then a way to just bulk email them or bulk spam them. And with a industry like MedTech and the community is so small, that doesn't really tend to work well, especially because you're talking to founders and CEOs that are passionate people that are looking to bring medical technology to help and enable patients and better their lives. So we wanted to create something that was a tool, yes, to help the salesperson and the marketing team in service provider companies to be able to identify the right companies to help at the right time. But we wanted a way for them to do it where it reflects the industry-wide belief of like, "hey, we're passionate people helping other people and that's our community." And so our tool was designed for that, right? That's what our philosophy is. That's how it was based around. We have this mission to bring humanity into MedTech business development. And we do so through suppliers. Lindsey Dinneen: Love it. That's awesome. That is a very needed service that y'all provide, so I'm so glad that you are out there doing that work. And thank you for sharing about it because it's great to learn about the various resources that are available. Kevin Saem: Yeah. Yeah, definitely. Lindsey Dinneen: Well, I'm curious, is there a particular moment that stands out to you because it clearly confirmed that this was the right career path for you? Kevin Saem: That's, that's a very tough question, Lindsey. For me to pick a time point in my life, honestly, I keep thinking back to a theme. I don't know if there's a particular moment, but I think there is a theme where, for me, I'm always looking for a way to create impact whether it's big or small, whether it reaches globally or it reaches my inner circle. That's always been my driving force of how can I do something that would benefit others around me in a positive way, and that would be long lasting? If I was gonna build something, it should be the best thing and it should do good. It's not enough to just do well. I think we should also focus on doing good. And so that's been my primary driver. And so a particular moment in my life that I remember, this was back in my Cambodia days, from a very young age, I was always interested in building new things. So if I was presented with some sort of toy I would be disengaged really quickly because the toy was already built. I'm just playing with something like a finished product. I gravitated more towards building new toys out of clay, that was more my style. And so that theme just recurred. Like through research I was building out new projects, new process, I was developing new things. In this role as well, bringing a brand to market, you have to build things. And so that I think is in my DNA, that theme of creating impact through building new things. Lindsey Dinneen: I love that. Well, And I know you've talked quite a bit about the creating impact theme throughout your life, and I just love that. I think that has clearly shown throughout your career and the various different things that you've done. It seems like having that running theme is really helpful because it guides you as you maybe look towards the next thing or how do I go about this project? If your goal is creating impact, then you always have that guiding light and I think that's really valuable. So I'm curious, how has that affected your leadership philosophy, or is that part of the way that you interact with others including in a leadership capacity? Kevin Saem: Yeah, that's a great question, Lindsey, and I think it, it does, it really does because in a leadership role I'm always looking to create positive, lasting impact as well for the people and for the business that I'm with. So it helps me to separate leadership from management in a way, if that makes sense. Lindsey Dinneen: Yeah. Kevin Saem: So for me, that helps me to put people at the heart of it all and then it manifests outside of that. So if you're leading a team of people you're constantly thinking and you got your worried hat on of like, "are these people being fulfilled? Is their work enriched? Are they doing well? Am I helping them unlock the next stages of their progression?" That type of stuff lives in my mind when I think about leadership. Essentially empowering people to do great things and helping them achieve their goals. I think that's what it's all about if you're serious about leadership. Lindsey Dinneen: Oh, I love that. Oh, that's a great definition of leadership. Amazing. How do you prioritize your own continued learning and growing as a leader? Kevin Saem: Yeah. That's also another great question. You're coming with the heavy hitters here. So, I just wanna take a step back. And I think two people that kind of help me understand what good leadership looks like. The first person was my PhD. supervisor professor, Jose Moran-Maribal. He had a way to approach leadership where it's like an extra layer of inclusion that he has in the back of his mind and his ability to help support his students was amazing. I learned passively just through watching. Another person that currently I report to actually, Pete, I respect as a leader and I emulate a lot of my thinking through these key figures and mentors. Throughout my career, I always have at every stage several mentors that I like to learn from, either passively or actively. And so I guess that's helped shape the meaning of what leadership looks like, and I use that to surround myself with those types of people. Lindsey Dinneen: Yeah. And so emulating has been a huge component in your own growth as a leader. Do you find that there are other resources that have helped you or continue to help you, or is looking towards those models of great leadership, is that primarily your source? Kevin Saem: My source is actually in the people that I surround myself with. It's silly to say, but I think throughout my graduate school days I've really finally learned how to learn or how to ask questions the right way. And I guess to summarize that, it's how to think versus what to think. Leading up all the way to graduate school, you're told you know what to think. This is right, this is wrong. And then throughout my graduate school experience, I really understood the mechanisms of how to think. And for me, my philosophy at continuous learning for leadership is trying to be the dumbest person in the room. It helps to protect me in a sneaky way where if you're the dumbest person in the room, you know there's only one direction, it's up, and you just learn so much. You just absorb everything, you soak everything in like a sponge. I learn things every day from the intelligent people that I have the opportunity to work with. And so yeah, I take that dumbest person in the room approach and ask tons of questions. That's the only way, I think, to really learn. And leadership is a funny thing where it's almost like trial by fire and you have to just go through it. You can read a lot of stuff-- obviously, I do read stuff-- but you kind of have to go through it and experience it and figure it out as you go and continuous process improvement along the way. Lindsey Dinneen: Yes, absolutely. Yep. Great advice. Okay, just for fun, imagine someone were to offer you a million dollars to teach ambassador class on anything you want. It can be in your industry, but it doesn't have to be. What would you choose to teach and why? Kevin Saem: Oh, there's so many bad answers to this and there's very few good answers to this question. I don't know if I am skilled enough to teach a quote unquote masterclass in anything, but if I were to pick one thing to teach, and this is probably another unconventional answer, it's probably the application of curiosity to fuel success in anything that you pursue. I think that's very underrated. As as a trait in people that are successful, I think they're intrinsically curious and they continue to be lifelong learners. Lindsey Dinneen: I love that answer. Yeah I absolutely agree with you. I had the good fortune when I was young, I was very curious and I was asking a lot of questions all the time. And I had an adult one time say to me, " You know, it's so good that you ask questions because then you'll always keep learning, so don't be embarrassed about it. Always keep asking those questions." And I'm so glad that someone thought to acknowledge that and point it out because it helped me retain that curiosity and not be afraid to be, like you said, the dumbest person in a room so that I could keep learning. So I love your advice. Curiosity is underrated and it's hugely important. Kevin Saem: Yeah, absolutely, and I think there was a drastic contrast when I was going to school in Cambodia and when the country was in recovery, it was very authoritative interaction between students and teachers. It was seen as like the teachers know all the answers and you should just be quiet, right? And just absorb knowledge from this beacon of wisdom, so to speak. And I would get in trouble in class all the time, I would be sent home with notes saying, " your son is just a troublemaker. He is asking too many questions in class. He, he is disruptive." And they don't like challenges to what they know in that kind of culture at the time. I'm sure it's changed a lot now, now that it's more modernized as a country. But when I came here, I was very surprised as to how much encouragement in Canada and in North America as a whole to like question ideas and question what's right and what's wrong. And always be very inquisitive and almost skeptical of what's presented in front of you. And I really appreciate that philosophy over in North America. Lindsey Dinneen: Yeah. Yeah, and that's really interesting perspective to have experienced both, so you can contrast and compare. What is the one thing you wish to be remembered for after you leave this world? I think I have a pretty good idea of your answer, but I'd still love to hear it from you. Kevin Saem: Oh my gosh. I'd love to hear you guess. Lindsey Dinneen: Okay. I'm gonna guess that it has a lot to do with impact in the various areas, whether it's personal or professional. But I will let you go into detail. Kevin Saem: You got it. I think you summarize it pretty well. You know, being remembered for having created something or opportunities or memories that has changed the lives of those around me in a positive way, I think that's enough for me. I don't need much more than that. Lindsey Dinneen: I love that. Absolutely love it. Okay, final question. What is one thing that makes you smile every time you see or think about it? Kevin Saem: Oh, that's a good question also, and it's a good one to end off on. There's one fond memory and like I said, it's like life-ception. It's like a life in a life. When I was living in Cambodia versus here, you had to really mature quickly when you're living in a developed country. As a young child, you'll understand kinda the risks when you take a step outside. There's dangers all around you. You learn to be quite self-aware at an early age. And I just remember there was a relative that came from France to visit the country and they brought a pair of roller skates back. And this was like a size 10 and we're like eight years old. And there's a group of just street kids playing around on the rooftops and stuff cuz we had concrete buildings with flat rooftops and that's where all the kids would hang out. And there's like about 10 of us and we remember just, we had a pair of roller skates and we were just taking turns using one each, actually, cause we didn't know how to ride roller skates. We're each just taking turns using one roller skate and just having the best time of our lives. And that reminds me of this, I guess, mantra that I have in my mind of " it's not about what you have, it's about who you share it with" and it's like that part of my life, we didn't have much, but we were so happy. We didn't know that there was anything outside of that. And so it's all about perspective, I think, and that's the memory that comes back to me that makes me smile every time. And I don't think anything else matters once you have things like that, that type of experience. Lindsey Dinneen: Yeah. Oh, I love that story that I'm just smiling thinking about it too. Thank you so much for joining us, Kevin. I just really appreciate your perspective and advice and bringing such a powerful background to the industry. I'm so thankful for the work that you do. We are honored to be making a donation on your behalf as a thank you for your time today to Save The Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational and safe environment. That was the organization that Kevin chose to support. So thank you so much for your time and thank you for all of your great quotable quotes. Kevin Saem: Quotable. Yeah. No, thank you, Lindsey, for putting all this together. I think what you're doing is incredible. I think you're highlighting the other side of MedTech, right, that is probably less technical, but is just as important. And I think you'd know, as better as I know, that storytelling is a big part of passing on knowledge and sharing with the community. And our community is so small that I think this is gonna really help bring us all together, especially coming outside of a pandemic years. This is a great, refreshing podcast. Lindsey Dinneen: Oh, thank you. I appreciate that feedback and yeah, that is the hope. It was so fun earlier when you were talking about bringing the humanity into MedTech, I just had to smile 'cause I was like, "there you go." We're very aligned. Kevin Saem: Yeah, that's right. That's right. Yeah. Lindsey Dinneen: Oh man. Again, thank you so very much. We just wish you continued success as you work to change lives for a better world. I know that impact is really important to you, and I know that you're gonna continue to make an impact on the world, so thank you. And thank you also to our listeners for tuning in and if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two, and we will catch you next time.  The Leading Difference podcast is brought to you by Velentium. Velentium is a contract design and manufacturing firm specializing in the development, production and post-market support of diagnostic and therapeutic active medical devices, including implantables and wearables for neuromodulation and other class three indications. Velentium's core competencies include electrical design, mechanical design, embedded software, mobile apps, contract manufacturing, embedded cybersecurity, OT cybersecurity, systems engineering, human factors and usability, and automated test systems. Velentium works with clients worldwide from startups seeking seed funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.   rjwA2u2Sx2mukDo1jErj

Lindsey Jardine is a Senior Clinical Research Associate at FARAPULSE, Inc. In this episode, she discusses her love of designing and organizing clinical trials, her zest for life and continual learning, and the very human moment in her career when she realized she had to make a major change from academia to industry.  Guest links: https://www.linkedin.com/in/lindsey-jardine-5a0985103/ Charity supported: Opportunity International  Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editor: Tim Oliphant Producer: Velentium   SHOW TRANSCRIPT Episode 012 - Lindsey Jardine Lindsey Dinneen: Hi, I'm Lindsey with Velentium and I'm talking with MedTech industry leaders on how they change lives for a better world. Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello and welcome to The Leading Difference podcast. I'm your host Lindsey, and I am so excited to introduce you to my guest today, Lindsey Jardine. Lindsey is a clinical trial manager renowned for her exceptional leadership and groundbreaking achievements in the healthcare industry. With a passion for advancing medical technologies, Lindsey has successfully managed two breakthrough innovations: one at Farapulse Inc. which was acquired by Boston Scientific in 2022, and another at Shockwave Medical that went public in 2021. Her entrepreneurial spirit has also led her to contribute to the success of Cala Health, now commercially available. Lindsey has earned a reputation for excellence in leadership throughout her career in clinical research. Lindsey, thank you so very much for being here. I am so excited to have you as my guest and welcome. Lindsey Jardine: Yeah, super excited to be here. Thank you so much for having me. Lindsey Dinneen: Yes, absolutely. I would love if you don't mind starting out by telling us just a little bit about yourself and your background and how you got to where you are. Lindsey Jardine: Oh yeah. I work in medical device. I work in clinical research. So the story of me, it's a long and twisty one, but I'm currently the Clinical Trial Manager at Boston Scientific in the electrophysiology division. So in electrophysiology, you kinda split in between cardio and neuro. So I've worked in both cardio and neuro. But yeah, just closed out my study for a atherectomyectomy device. Lindsey Dinneen: Yeah, that's great. I'd love to hear how you either intentionally explored the medical device industry or whether you meandered in, either way I just love hearing the background of what got you to where you are. Lindsey Jardine: Yeah. So my background was originally in biochemistry. So I went to school to get a degree in biochemistry, and in biochem there's only basically two ways that you can go in any kind of industry. So you can go into academia and do a PhD, or you can go into medicine. So in a PhD you'd usually go into genetics, which is a fascinating topic. Genetics is super fun. So I did work in a genetics lab after I graduated college, but with the intention of going into medicine, so while I was working in the lab doing a lot of like really interesting genetics work at UCSD, I was also studying for my MCAT, which did well, got into med school. While I was filling out the financial paperwork, I looked around and I was like, "everyone in medicine is miserable." And then I had this moment where I was just like, "you know what? I don't know if this is what I want." Because in medicine you have this grind and it's like the glory is in the grind. And you sacrifice, and then eventually maybe you'll save some lives and your time on this earth will be worth it. But that seemed like a really bad idea because I love being outside. I love my family. I love my friends. I wanted to love life in a very profound way, so I decided that sacrificing everything for maybe some kind of hope that I'm going to further the human race was probably not best served in a hospital. So I got very lost for a long time. Continued working in the lab doing genetics. I was like, "okay, maybe I can help figure out some cures. Maybe I can figure out some other way to help humanity at not costing me my life." So started working in research, decided that I was not a lab person, not because I don't love the problem solving of the lab, it's just more of a very isolated not as personal. So, I was at lunch one day and somebody who works in clinical research at UCSD, she's "oh, why don't you come into our office and our clinic and figure out what clinical research is all about?" I was like, "Oh. That's a thing. Clinical research, I don't even know what that means." That's not really a degree that you can have in undergrad. It's not really something that you really hear about. At least when I was in college or immediately after post college, that's not really something that was, I'd never even heard of before. So, I started working at the Chelie Eye Institute, which was also like, not to get into too many too much detail, but a lot of genetic abnormalities present in the eye. So there was like a really strong genetic component. But also I got to work with patients in clinic, which was really fun. So on the hospital side, you get to implement a lot of other people's research and you get to interact with people and you get to see the benefits of research on a daily basis. So I fell in love with clinical research. Then eventually I was recruited to work on a project at Stanford. So then I moved from San Diego up to the Bay area, started working on the baseline project at Stanford, which was a collaboration with Google and Duke University. So, that was a lot of fun. That was a lot of logistics that project was logistically super complicated, which was fun. I love that. That one was trying to figure out how all the puzzle pieces fit together and then also getting a really good deep dive into like data science. So that was my first like foray into like data science which was really fun. And then also I got to see what industry is like. So from up until that point, my entire career was in academia. And I did like academia, but it was definitely still that grind that no matter what you do, it's never really gonna matter. You might serve somebody at some point in some time and then your life's gonna be worth it. It's like this noble sacrifice basically. But so then I got to see what industry is like and how innovative it can be, and like that really tickled my creative process and that was something that I really fell in love with was being able to move really fast, help a whole lot of people, and be creative in the process. And you get to put together all these like logistics puzzle pieces and understanding the science and really deep diving into something that gets noticed and that helps people in the immediate. So that's that juxtaposition with academia and industry is-- academia you grind forever and then maybe someday you'll get a card saying, "You saved my life 10 years ago and my grandkids are now amazing people and it never would've been possible without you." But in industry you get that immediate kind of reward, like you see it come to market and you see your project. All that sacrifice, all that immediate hard work that you put into something, you see it come to market. And it's really fun and it's really great and you get to see it from not that 10,000 foot view where we're all contributing in the greater scheme of things. It's-- you get to see it, like you run a study of 20 people and you see the immediate effect of those 20 people. So that's why I chose MedTech specifically. But yeah, so, after Stanford, I moved into the startup space. I started working at Cala Health which was neuro. So, that was my first transition into the electrophysiology, neuro cardio kind of space. For anybody listening who doesn't understand what electrophysiology is, it's basically understanding the way electricity governs your body, which is a really fascinating topic to me 'cause I'm a physics nerd. I love physics. So, being able to take all of my physics information, all my physics, like chemistry background, and then getting to split that time between the brain and the nervous system and, and the heart was really interesting. So that's when I fell in love with the heart and the brain. But yeah, so Cala Health is doing really great. They're commercialized. I was part of the team that put together some of their early feasibility trials and also their pivotal trial, which was a lot of fun to work with them. And then almost immediately after that they got commercialization and being able to understand and talk through or hear the leadership team strategize for something like that was really interesting. And that was a whole new thing that I had never even seen before. Like, how do you bring a product to market and what capacity, who are we gonna reach? Who is this best suited for? So listening to all that strategy was really fun. And then after that I worked for a company called Shockwave Medical, which is an atherectomyectomy device. So that's a cardio. So electrophysiology in the heart space. And that was a super fun, that was a breakthrough IDE/PMA trial. So it was huge. It was global. It was a lot of moving pieces that, all those logistics that I loved with the electrophysiology portion of it and I got to work with great leaders, and that's one thing that I find like really consistent about when I'm choosing my next job or my next project. I look at the leadership team and I get to see how they approach problems and that is how I make my decision of who I wanna work for, is if you approach problems in a methodical and innovative way, I love seeing that. I love being inspired by that. Those are the kind of leaders that I look up to is how well they approach problems in their thought process and their ability to innovate in a space that's either new or has been done a thousand times, either one. But yeah, so worked at Shockwave, we were able to go IPO, the company went public and then we closed our trial. We started moving into the post-market trials, and I just still have that adrenaline high from the breakthrough study. We can get into this a little bit later, but those breakthrough PMA/ IDE trials are huge and they are a lot of logistics. It's very intense. It's a lot. It's a lot. And it's a grind, but in a fun way. For me, I love this. I love. So yeah, the thing that attracted me to medicine also attracted me to the breakthrough kinda trials, those breakthrough pivotal trials. And so after that I was like, " I need another one." So I started looking. I got approached by a recruiter and this recruiter sent me a bunch of stuff and then I saw the Farapulse offer come across saying that they were looking for a clinical trial manager for their pivotal breakthrough trial. And I was like "That company looks like it's gonna change the game." Same thing with Shockwave, also changed the game. So I got on board with Farapulse which is another cardio EP, electrophysiology technology. And it was magic from the very beginning. And we just closed our trial-- which that trial had its own complications. It was a blinded trial and all the sites and like trying to figure out how to do all that through Covid, through all the things. So that's how I got to where I am now. Eventually, last year we were acquired by Boston Scientific. So, yeah, that's the very short background of how I got here, and now moving on to my next adventure, which is gonna be back in the neuro space. Lindsey Dinneen: Nice. Oh, that's so exciting. That is something that kept resonating with me as you were talking, was just your enthusiasm and passion for this particular industry and for your role within it. And it's just so much fun to hear how all of your different interests and passions are coming together in a way that, it sounds like just keeps you constantly engaged with the process, and you know that you're making a difference as you get to see it right in front of you. It sounds fabulous. Lindsey Jardine: Yeah, it is. It is. I really do enjoy my job, even like the daily logistics, and not every day is magic. Some days are just the grind, but then two days later or a week later, you're back inspired. So I do love what I do and I love the pace in which the trials that I do sign up for go and it's really fun. Lindsey Dinneen: Yeah. So, in your role as manager for someone who doesn't know what a typical clinical trial might look like. How does it work? Is there like a typical process or it, I'm sure it varies per trial, but I'd just love to hear a little bit more about how you go about even organizing it to start with. Lindsey Jardine: Yeah. Oh man. Oh, that's a good question. So there is, the FDA does have a reasonably prescribed way to put together a trial. So, when you're working in the startup space, what happens is you have somebody with a great idea. That person usually doesn't know how to build it. They usually don't know how to commercialize it. They usually don't know how to run a trial with it. So they have this great idea and then they go about trying to build this leadership team. So you'll try and find a CEO, you're gonna find funding, you're gonna start like prototyping some stuff. And then once you get to a point where you think that what you're building is viable, you bring on some engineers that work in the space, that are professional, they work in the startup space, kind of the same way I work in clinical trials. There's definitely people who work specifically in startups to engineer and build stuff like this. So you bring on an engineering team, they build it, they test it, and then once they've gotten it to a point where, It's a viable product in a lab they usually bring on somebody like me, clinical trial manager, preclinical trial expert to start testing it in larger animals before we go into humans. So then you start putting together your preclinical data. And a lot of the times that's where somebody like me would jump in as a clinical trial manager or a clinical trial expert in some way. So it's usually not necessarily a clinical trial manager, but a clinical trial expert. In the service space, it's a fluid term. You could call 'em clinical trial specialist, whatever you want, but again, it's just somebody who has the expertise of bringing something from an engineering perspective all the way through market. So, in that process, I get to build the protocols. I get to ask the questions. I get to set up the preclinical work so I can inform my clinical work, if that makes sense. So when we're putting together the preclinical work, you're putting together the studies, you're understanding the device, you're understanding the product, you're understanding the demographic that you're going after. So, the disease space basically. So that's one thing about clinical research, as somebody who specializes in clinical research, is the disease space changes with the technology. So I've worked in electrophysiology and neurology, so, atherectomy, ablation, therapy, neuromodulation. So the disease space changes, the technologies change, but how you think about your job and how you approach things should be consistent, so it's that innovation. I think that's really what the difference is when you go into academia is you focus on as a very specific disease space and you focus on one very specific and you get into the minutiae of one specific thing. So if you're going into medicine you specialize, you subspecialize, and then you really understand that one protein of that one gene. So, coming back to where I am now, I don't necessarily understand one specific disease, I have the opportunity and the privilege to work with a lot of different disease spaces. There's a lot of different products and I get to understand and innovate and build my knowledge as I move through my career. So I've worked in a lot of different types of medical devices and it's really fun being able to learn from the engineers and learn from the physicians, and learn from all of my colleagues as I go through my career. So I'm building my knowledge as I go along. So my specialty is building clinical trials. So to answer your question, there is a reasonably prescribed way to do it, but that prescribed way is driven a lot by your logic. The FDA is your partner in all of this. So they have regulations that you have to follow. So as you're going through and you're building this process, as you're building these clinical trials, you have to make sure that you're adhering to all of the regulations that the FDA has set forward. So that's everything from building your internal standard operating procedures at your company to making sure that all of your regulatory documentation is above board and your operations, all of that stuff. So the FDA's your partner through all of this and making sure you're putting together a clinical plan and/ or protocol that is safe, effective, gets at the correct end points, targets the right demographic of people, disease state, and making sure it's safe and effective as you go through all of these steps from preclinical all the way through clinical. Lindsey Dinneen: Yeah. And that actually brings up a question that I had, and that is, have there been any moments that have been scary in clinical trials because part of it from my understanding, please correct me if I'm wrong, is that you are trying to establish, not only does this product work as intended, but is it safe? And of course you hope you've done enough pre-work with that to have a solid idea. But are there moments where you've just been like, whew, that did not go as planned? Lindsey Jardine: We have a term for that. It's unexpected adverse events or unexpected device malfunctions, but that's a good question. So it's yes and no. To be clear: one, you want to make sure that you study your device in the preclinical setting as thoroughly as possible. So that's your engineers. And your engineers are also going to the FDA for pre-submission and the FDA's double checking everything. But with that being said, that's why we do so much diligent testing before we put it in humans in order to make sure that once we get into clinical trials, it is absolutely safe. So, protocols, they test out for years after a procedure. But to make sure that we have all of our ducks in a row, all of our T's crossed and I's dotted, we're not gonna hurt anybody. I've never been a part of a product that I was ever afraid was going to hurt somebody. That being said, there are definitely times in lab where just " Oh, that happened." So there's definitely times where you're just like, "Oh my God, how did that happen?" In a lab setting, but never in a clinical setting to be very clear, I've never been a part of that. So in a startup, you'll have like your engineering on one side of the building and your operations or something on the other side. But when you're going through user testing or trying to design user interface, the engineering department will bring somebody in you're like, "Hey. I'm gonna teach you how to use this. Let me know if this makes sense to somebody who doesn't build it." So, I've definitely been in a few situations where I was using something and something unexpected happened. I was like, "What was that?" They're like, "Oh, we found a bug!" So, stuff like that definitely happens, but I've never been clinically in fear of any of the devices that I've worked with. But I also work with really amazing engineers and really amazing physicians. So that's another really great part about what I get to do is I get to collaborate with physicians who do this for a living, who do that very specific, very granular work in one very specific disease state. So they also inform and help, and it's ultimately their responsibility to make sure that whatever they're using on their patients is safe and effective. So that's why we work really closely with all of our physician surgeon collaborators to make sure that we aren't doing anything that could hurt anybody, cuz that's obviously, that's the opposite of what we wanna do. So yeah, that's another thing that I love about my job is the collaboration. Lindsey Dinneen: Yes, it does seem the more that you've talked, the more I can sense how much you enjoy working with people and having that collaboration, that problem solving, we're in this together trying to make a difference. That's really cool. Another thing that you brought up that I really liked and something that I tend to ask my guests is about how you as a leader in the industry continue to prioritize your own learning and growing. And it sounds, because you get to work on so many different devices and with so many different indications, you really have this opportunity. It's almost built into your job. And then it just sounds like you as an individual are just a really curious person. So you're probably getting to learn and grow all the time. There's no stopping it. Lindsey Jardine: Yeah, that's true. It's true. There is no stopping it. Honestly, that's why I chose the space that I'm in is I love learning. It's one of my favorite things in life is just expanding my knowledge base, learning fun new things. And even in my personal life, I'm always going out exploring, doing new things like learning and absorbing the world that we live in. And that's one consistent theme of my life is I just want to love the life that we have right now. And so learning and exploring and doing and driving yourself to, to a point of excellence is something that I truly enjoy doing. But yes, that learning is my job. And if I ever stop learning, I think that I would stop being good at my job. And hopefully by that time I can retire and learn something new, learn something that I haven't learned or even attempted to learn before. So, to answer your question, learning is definitively what I get paid to do. Lindsey Dinneen: I love it. I love that. That is fantastic. Yeah. So is there a particular moment during your career that stands out to you as kind of a defining moment of "Yes, this is the right industry for me." Just confirmation that you really chose and that it was fulfilling some of those deep desires that you've had. Lindsey Jardine: Yeah. That's a really good question. I can't say that there was ever one like lightning moment that told me that I was on the right path, but I do recall one specific moment where I knew I was on the wrong one. I think that the consistent feedback that I get throughout my career now is a continuing affirmation that I've chosen the right path and the fact that my personal happiness gets more-- like I, I gain more and more happiness with every passing day of my job. Not to say that you have to be happy every single day. I think that there is definitely something to be said with the highs and the lows in a moderated way, not the extreme highs and lows. But I consistently reaffirmed that I made the right decision. But I remember probably the lowest point of my career that I had to take a step back and say, "This is not okay for me." I was working at that, the baseline project, and a lot of my mentors would call me probably more of a racehorse kind of personality, where I want to do stuff, I wanna improve, I wanna run it at full speed. And working on a project that was that logistically complicated with that many people and that many things, it was really fun. But, in the academic space, slow and the hierarchy, and it was definitely not my my favorite place because I remember there was this one instance where we had this intern and I was helping him and he and I were collaborating on a project and I was like, "Okay, this is how I'm gonna put all this stuff together." And I have, like I'm known for my spreadsheets. I have this 80 tab spreadsheet and we're putting all together and we're putting all these formulas together. And he was helping me and it got to a point where I was like, "Man, I am super proud of this." I was really excited that I got to learn something about putting all of this stuff together. And I got to teach it as I was learning it. And I did it and then I got to teach it and then I got to see him like do some stuff and he felt very rewarded by it. And I felt very rewarded by that too. So that particular project had lots of different principal investigators. So we had four different principal investigators that I can remember. And so we're in a room of 30 people. All of them are my superiors and obviously his superiors. But I'd found out that he had taken my work and he had presented it to my boss's boss as his own. And I had no idea that this was happening. And so I'm sitting in this meeting and he's presenting my work and you can't really stand up and be like, "Hey, get outta here, that's mine. I taught you that." And I was just fuming in this meeting. And there's just so much bureaucracy in that context that even if I were to say something, it would've fallen on deaf ears. And I did say something to my supervisor and they're like "Sorry, it's for the greater good." So, oh no, and I was just furious. And so I talked to him after and I was like, "Hey, you just put your name on my work." And he's, " I've changed the color scheme." And I was like, "Did you now? That's so cute." But there was like, there was no repercussion. There was no anything. So I probably did an immature thing and just stopped talking to him. And he didn't take that very, he was an intern. It's fine, but so I'm just like, I'm not working with you anymore. I can't trust you. So he brought me flowers and he put them on my desk and I threw them. And that was brought like, but I remember like taking these flowers and throwing 'em at a wall and I was like, "This is a bad spot. I should not be here. I'm setting myself up for failure." So, that's when I decided that I needed to leave. So I moved into the private industry, which was much more intimate. Everybody saw everybody else's work. Everybody knew, everyone was all striving towards the same thing, and it was never an ego trip for anybody, if that makes sense. And there's always that greater good feeling like we're all trying towards the greater good, but you personally are not sacrificing for somebody else's glory. And that's the thing that really got me about academia and that kind of " grind until you die" space. I was like, but. I did that. I feel good about that. Not that person gets to present my work and they get to feel good about it. So, to answer your not question. That was the moment where I knew I was in the wrong place. Lindsey Dinneen: Yeah. But those moments are just as important cuz they're teaching you what doesn't work and what does not align with who you want to be or, or how you wanna show up in the world. So I think actually, I really appreciate you sharing that story in that very just sort of human moment because I think it's so important to be honest about those kinds of moments that also are exactly what you said, " this is not the right path for me." And then it sounds because of that experience, you were able to go, okay. It's not like I have to get rid of the entire industry or anything like that. It was just, this isn't the right place for me and I'll find the right place for me. And I think that's really important too. So. Yeah. Lindsey Jardine: Yeah. And I do get reaffirmed by my job every day, and I love that. So it wasn't some shock, like lightning bolt moment, like this is the one. It was a slow burn that keeps burning brighter over time for me. Lindsey Dinneen: And I love that too, because how wonderful is that? It's not just this one flash of inspiration, which could be the catalyst to continue on the path and do something great and whatnot. But I love that you're in a position now where you can just be constantly, maybe in very tiny little ways, but just constantly reaffirming this is right. And that's special. That's really cool. Lindsey Jardine: Yeah. That is special. It is. And being invited on a podcast like this, I'm like, "When did this happen? When did I become the leader?" Like yesterday I was throwing flowers at people in a violent way. And all of a sudden I've been getting interviewed for a leadership podcast. Yeah, there's definitely been some significant changes that, all of a sudden, you turn around and you're like, I am the person that I wanna be. I did get here. This is amazing. Lindsey Dinneen: Yeah, absolutely. I worked hard for this and it is paying off. And yeah, I can change and grow. That's great. That's fantastic. Lindsey Jardine: Yeah, it is. Yeah, it is very special. Yeah. Lindsey Dinneen: Just for fun, I'm gonna take the interview in a slightly different direction, but imagine someone were to offer you a million dollars to teach a masterclass on anything you want. It can be in your industry, but it doesn't have to be. What would you choose to teach and why? Lindsey Jardine: Oh man, that is another really good question. You're making me think. I like it. I would say if I could teach a masterclass in anything, it would be confidence. When I was sitting there watching my work that I've been, the project that I've been working on for months, being presented by somebody else, and then my reaction to it, that was a deep feeling of insecurity. And I think building confidence is a very important thing and building the appropriate confidence is another very important thing. I mean, for many years I was a "fake it till you make it" person. But having all of that insecurity being presented and then having somebody else take credit for my work, and then everybody else saying " So what, who are you?" If I had more confidence in myself, I would've reacted differently. And if I would've had more confidence in my ability to figure out problems, I would have not put myself in that position. I would have figured out how to get out earlier or figured out that "grind until you die" was not the right path. So if I could build a masterclass, if I could help people understand, knowing their own personalities and finding that confidence in themselves. And I think that is an invaluable skill in any industry is not that you don't have to be the person up on stage presenting the project. You can have your own confidence in building something and saying " that's mine" and owning it as opposed to having that insecurity and exploding all over everybody. So I would say that, yeah, I think that is definitely something that we are facing in a society that is troubling to me is the we're gonna go meta completely away from my specific story, but I see so many people with anxiety, I see so many people with imposter syndrome. So many people that even like Instagram, all these like social media feeds, it feels like a very deep-seated insecurity. And I dislike that. I dislike how we have to look a certain way or have to act a certain way or like all of these different movements to make people be seen and understood. And if we could collaborate and if we could speak with confidence, if we could speak with understanding that everyone here has some issues and if we could speak confidently about what we know, if we could be confident about who we are, then I think we could solve a lot of problems and not erupt into this, this really controversial space. So I know that having confidence also means having compassion and having that ability to reach out and say, "these are my flaws, but that doesn't mean I'm incompetent. I'm confident in myself. I'm confident that I know that this is the space that I don't know anything about and I need somebody to teach me, and that has so much confidence." And that's another thing that I've learned over my years of working in clinical research is there is no space, there's no time to fake information. You have to learn information and you have to have the confidence to say that, "I don't know this. I need to learn it." No matter how stupid that question is. "I need to learn that piece of information so I can do my job confidently and I can be confident in the product that I'm putting forward." So, if I was going to teach a masterclass, I choose confidence. Lindsey Dinneen: Yeah. I love that. That was really insightful too. I appreciate your perspective on confidence and, like you alluded to, appropriate confidence too with empathy, with compassion, with collaboration. Lindsey Jardine: You can't possibly know everything. But somebody else knows something. And if they don't know it, you have to have the confidence to be able to figure it out. Lindsey Dinneen: Right. And that curiosity is a strength. Because you don't know everything. Like you are highly specialized in, in many different ways, and you have this fantastic capacity to learn, but it doesn't mean that you're necessarily an expert in every single thing you come across and so having the confidence to be curious and to say "I, I didn't know this. Tell me more." That's fantastic. Lindsey Jardine: That's truly it. That really is the curiosity and the confidence . You said it really beautifully. Just tell me more. Teach me everything and then we can change the world together and we can be better people to each other. Lindsey Dinneen: Yes. I love it. What is one thing that you wish to be remembered for after you leave this world? Lindsey Jardine: Oh my goodness. That's a really good one. The one thing that I wanna be remembered for I would say, my confidence. Yeah, I would say my confidence. And that's my all-encompassing confidence, compassion, and curiosity, because I roll all of those things up into confidence, if that makes sense. So my confidence doesn't come from perceived understanding of myself, but it comes from the feedback that I get on a daily basis from my family, my friends. My confidence is something that I hope inspires and I hope that people remember me for the type of confidence that I have. How about that? The type of confidence. Lindsey Dinneen: Yes. I like it. Awesome. Okay, final question. What is one thing that makes you smile every time you see or think about it? Lindsey Jardine: Oh, man. Okay. The one thing that makes me smile. I would say, life. That's not too tacky. Yeah. Life makes me smile. I am continuously impressed by the world around me. And that comes with all of the changes that life brings, and it's not always pretty. It's not always great. I've definitely had some times where I didn't wanna do it anymore, and I want to encourage anybody who's listening, who does not have that passion for life to just wait cuz it does get better. Because I, I threw flowers at people, and not in a fun way, in a very violent way. There's definitely times where I was not happy or impressed with life and I didn't wanna do it anymore, and I just I didn't think the next thing was gonna be any better than the last. But I can honestly say right now, life makes me happy, not on a daily basis because I think it's a misconception that you have to be happy every single day because you don't really understand happiness and you don't really understand what life has a capacity for until you know what the bad looks like. So having bad times is just as important as having good times and understanding that the next piece of your life has the potential to be the best, has potential to be better than anything you've been through so far. But it makes me smile every day knowing that I get to keep doing this in this space and time that we're in right now. And in the world right now, there's turmoil everywhere, but I am very encouraged about life and it makes me happy because I get to see how hard everybody works. I get to see that we are going through something very profound and I'm very confident in the future. And life makes me smile. Lindsey Dinneen: Oh, I love that. That's the first time anyone has said that, so I love it. Beautiful answer. Lindsey Jardine: Thanks. It's kinda meta, but that's the one thing, yeah I don't know. Boyfriends, girlfriends, family, the sunshine. All of it's nice. All of it's good. Life makes me smile even when it's making me cry. It's the pain and the struggle and the future that, that just inspires me. And I love that and that makes me happy. Lindsey Dinneen: Absolutely. Lindsey, it has been an absolute pleasure to have you on the podcast. I just really appreciate you taking the time to join me today. We are really honored to be making a donation on your behalf as a thank you for your time to Opportunity International, which designs, delivers and scales innovative financial solutions that helps families living in extreme poverty build sustainable livelihoods and access quality education for their children. So thank you for choosing that organization to support, and seriously, thanks again for your time. I just wish you the most continued success as you work to change lives for a better world. I love the fact that you have such a passion for life and for your work, and I know what you're doing makes a difference, so thank you. Lindsey Jardine: Thank you. I really appreciate you having me on. This was a lot of fun. All your questions were so good. I loved it. Lindsey Dinneen: Good. Glad to hear that. Lindsey Jardine: Thank you for doing this, for doing you. It's very inspiring. Lindsey Dinneen: Appreciate that. I appreciate that. And thank you also to our listeners for tuning in, and if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two and we will catch you next time.  The Leading Difference podcast is brought to you by Velentium. Velentium is a contract design and manufacturing firm specializing in the development, production and post-market support of diagnostic and therapeutic active medical devices, including implantables and wearables for neuromodulation and other class three indications. Velentium's core competencies include electrical design, mechanical design, embedded software, mobile apps, contract manufacturing, embedded cybersecurity, OT cybersecurity, systems engineering, human factors and usability, and automated test systems. Velentium works with clients worldwide from startups seeking seed funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development. B5IkdlvEu8YlwXbE9H3a

Miguel Adao is a passionate leader in the medical devices, internet of things and consumer wearable spaces, and serves as the Senior Vice President of Sales & Marketing for Voler Systems. In this episode, he discusses how living in nine countries and traveling to over 65 has impacted his life, the difference between managing and leading people, and the importance of having a "North Star" to guide your decisions and actions. Guest links: https://www.linkedin.com/in/migueladao/ | https://www.volersystems.com/ Charity supported: Save the Children Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editor: Tim Oliphant Producer: Velentium   SHOW TRANSCRIPT Episode 011 - Miguel Adao Lindsey Dinneen: Hi, I'm Lindsey with Velentium and I'm talking with MedTech industry leaders on how they change lives for a better world. Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello and welcome to The Leading Difference. I'm your host Lindsey, and I am excited to introduce you to my guest today, Miguel Adao. Miguel is a passionate leader in the medical devices, internet of things and consumer wearable spaces, and works for Voler Systems. Miguel, thank you so much for being here today. I'm so excited to chat with you. Miguel Adao: Yeah, Lindsey, thanks for having me. I'm really looking forward to our chat as well. Lindsey Dinneen: Absolutely. Well, I was wondering if you don't mind starting by just telling us a little bit about yourself and how you got into this industry. Miguel Adao: Sure. Yeah. Oh my, where do I start? It's been an interesting ride. I've lived in nine countries. I was born and raised in Portugal, in Lisbon. Went to high school in Rome, Italy, and then I lived in Paris, France, in London, England, in Munich, Germany. Spent many years in Rio and Sao Paulo in Brazil. Lived in Buenos Airs in Argentina. I went to college in Florida and grad school in Ohio and doctorate school in New York. And I've worked for some fantastic companies. I worked for Proctor and Gamble and Pepsi, and Hewlett Packard and Petco, the retailer, and Cigna Healthcare. That was my first kind of exposure to the healthcare side in a way. And now I live in San Diego. I'm married to Lindy. She's British and we have two teenagers. Olivia's 15 and Nico is 13. And I joined this company called Voler Systems almost a year ago in May of 2022 and we focus on medical devices. We help healthcare and medical and wearable and IOT companies develop and design their prototypes and their devices. And I just love where I am in my career at this point in my personal life with with my family and geographically. We love San Diego. So yeah it's been a very interesting journey, indeed. To your second question, the whole medical healthcare side obviously touches all of us personally, right? We have parents and relatives who get older and unfortunately sometimes sicker. So it touches us on the personal side. I lost my father years ago due to a health condition. So, on that personal side, I have obviously strong affinity to this industry and to this space cuz I want to make the world better. And it's almost a cliche, but I also wanna help people live longer and healthier lives. And then on the professional side, I'm trying to think. I've worked so closely with healthcare and medical devices and pharmaceutical companies through the years. When I was at Hewlett Packard for 12 years, I worked for a company called VMware as well. I was with Cigna Healthcare Insurance for three years, and now at Voler Systems, 80% of our business is around medical devices and medical wearable devices as well, not just the FDA classes one, two, and three. So not just on the scan, like a wearable watch or ring or a skin patch. But also other types of devices that actually go inside the body, like a stent or a catheter or perhaps devices that are used in robotical arms for surgery, et cetera. So I'm very close to the medical device world and the MedTech Industry as the Head of Sales and Marketing here at Voler. And yeah, from a personal side, I'm very passionate about this industry as well. Lindsey Dinneen: Yeah. Well first of all, your background is so cool, and I love that you've lived in so many diverse places. I, I have to ask, is there a favorite? Miguel Adao: I get that question all the time and my, my kind of cheesy answer-- my wife thinks this is so cheesy, Lindsey-- I love the most the place where I am currently. Lindsey Dinneen: Oh. Oh, that's great. Miguel Adao: I always say that. I always try to at least, I don't always succeed, but I try to live in the here and now, so I try to enjoy the most the place where I am currently. But certainly looking back, I'm very biased to Portugal. I love going back. I go back twice a year to visit my mom and my friends and family. In fact, I told you before the recording, I'm going to Portugal next week to visit my mom for a big 80th birthday. I'm so excited about that. So I always like going back to Portugal, but my favorite country in the world is by far Italy. Both because of course, historically and culturally, and in terms of beauty and architecture and food and fashion, it's astounding. But also just because I lived there from the ages of 14 to 18, went to an American high school in Rome, and those are formative years. That's when you start to become an adult and you start to really define who you're gonna be and, and who I am today is in large part because of that time in, in Italy. So I absolutely love my time there and I love living in California now. Lindsey Dinneen: Yeah, absolutely. Well, I love that perspective. I think that's a great way to go about life and just enjoy where you are in the moment and I guess also take the good from the various other places you've gotten to experience along the way as well. So I love that. But I agree with you that Europe definitely has some particular charms. Miguel Adao: For sure, as does the US, as does Asia. Lindsey Dinneen: Of course, as everywhere does. Miguel Adao: But it's interesting. Yeah, this whole thing, I've been talking a lot with my wife about this as well. She's a life coach and it's very interesting how, isn't it true? Isn't it just so absolutely true that we in our lives spend most of our time revisiting the past with regrets or anger or sadness or whatever. Or pre-living the future with anxiety and doubt and insecurities. We're never in the moment. Right? I've been talking about this with my teenage children as well. We're always worried about what's going to happen next and sad or regretful or upset about something happened in the past and I think that's just something I've been working on myself and it's been an interesting topic for my family as well. If you can live in the here and now, just enjoy this moment and just learn from this moment-- don't have to enjoy it, not everything is joy in life and thank God, because you need to have a balance. But it's an interesting challenge that I'm presenting to myself, and I'm using this podcast on industry with you, Lindsey, to remind myself, just enjoy this moment, enjoy this podcast and nothing else matters. Enjoy this podcast right now. Lindsey Dinneen: I love that. I love that perspective. Well, and that actually brings up an interesting thought. So, you know, as you were talking about that I absolutely agree with you, but what's interesting is in the medtech industry specifically, there's of course such an emphasis on innovation and it is partially to either solve past dilemmas or perhaps anticipate future ones. So, how do you think about that in terms of your role of sales and marketing for Voler? How are you able to stay present and grateful for the here and the now, but also think about it in terms of the industry, which sort of naturally has to be both problem solving and problem anticipating? Miguel Adao: That is such an interesting way to look at it. Yeah. Let me think about that for a second. I really like that. And I guess it could apply to most themes in our personal family or professional lives, right? You gotta learn from your past, obviously. You gotta just not repeat the same mistakes of the past. I think that's a definition of insanity, right? So you wanna learn from that. And obviously you are looking to the future. We all want in the medtech industry to cure cancer, right? And obviously you wanna have a future goal and you want to learn from the past experiences, failures and successes, and certainly I'm a marketer before being a business development guy. Really, my entire career was in marketing. And marketing is nothing more than storytelling. It's about basically bringing folks along with you on a journey so that they can find what you're presenting or delivering or selling impactful and beneficial and insightful. And so as a storyteller, whether we're storytelling from a brand perspective, from a digital podcast, a program or whether we're talking to a potential customer or existing customer, you wanna be able to tell that story and to be able to articulate that vision of how exactly your organization will help them accomplish that future goal. Learning from the past experiences, but we're doing it today, right? So, the present in a way is the bridge between the past and the future. Right? And so in my day-to-day, although I haven't really thought about this in this light, but your question kind of makes me think about it-- both from a business development and from a marketing standpoint, what we wanna do is help our organizations or partners or customers essentially help their end users, right, i.e. either consumers or their patients with better outcomes and so what does that better outcome mean? It means curing a disease or it means extending the life of someone or resolving a medical problem of sorts. And so from my company's perspective, If our engineering prowess can help a medtech company develop a device and launch and improve a device that will make people's lives better, healthier, and longer, then that's it. What else is there that more aspirational than to help people live a better life. I don't think there's any other industry that can come close to the medical and the MedTech industry in terms of making the planet and the inhabitants of the planet better. Lindsey Dinneen: Yeah, absolutely. That's a great answer to that question. And I think that like you said, it's just such a unique industry in that way. And so it, it definitely brings up different considerations perhaps than other jobs or careers. Okay. Well, is there a particular moment that stands out to you because it clearly confirmed that this was the right career path for you? Miguel Adao: Yeah, certainly as family members have become ill or even lost their life because of medical conditions that certainly raised my awareness as I was growing up and becoming more and more aware of my mortality and others, the people I love and their mortality and their lives. So certainly the fact that I've been touched as perhaps have all of your listeners and, and folks that we know been touched by illness and by medical conditions, if not ourselves, and by those we love. That always was in the back of my mind. And although I've worked in soft drinks and hair care, when I was with Procter and Gamble, I worked with Pantene and Head & Shoulders, and that's not saving lives necessarily. It's making you, I guess, feel better about yourself And that's also important for mental health, et cetera. But really throughout my career, as I got exposed, as I said with Hewlett Packard, a lot of engagement with hospitals and medical groups in England, I worked with HP in the UK and also in Germany, and that was my first exposure and it was, it's just so, what's the word I'm looking for? Empowering and rewarding. That's it. It's so rewarding to work with a company with a customer and providing a solution, a technical solution or whatever, when you know that solution is going to make people's lives healthier and longer and better. More, more than just, I don't know, build a better golf club which is important too, certainly if you're a golfer. But my exposure at HP to hospital groups, medical organizations was the first time where I really got this personal satisfaction of seeing that what we're doing with our HP computers and printers and devices was actually helping the hospitals and the surgeons and the nurses and the practitioners make things better for their patients. And so when I was approached by a head hunter last year to join this company that is focused on MedTech and medical device development, Voler Systems, I met the founder and the president, still my boss, Walt MacLay, and we just hit it off and I wake up in the morning, the alarm goes off at six, and I'm excited because I feel like, "okay, we're gonna work not on a chip or a sensor or we're not gonna work on a wireless connection or power management solution. We are working on something that will make somebody's mom, daughter, sister, friend, live longer and live better." And so, that makes me want to get up and makes me want to put in another good day of work. And approach it with a lot of passion. If I may say this, Lindsey, it's an analogy I always like to say also when I'm talking to new employees who join my team or others, there's this old story of the king visiting these folks, brick layers putting bricks down on this construction. And the king asks the brick layer, "what are you doing?" "Oh, I'm just laying my bricks." Day after day for the last 40 years, and I'll lay my bricks. And then the king asks the second brick layer, "oh, I'm building dreams. I'm helping to build cathedrals and visions that will last generations long after I'm gone." And it's like if you have that vision, that what you're doing is more than just a stupid little brick, then your contribution is so much bigger than that, and therefore your passion about it will be commensurate to your vision of what your contribution is. Lindsey Dinneen: Yeah. I love that. I also love that story. Thank you for sharing that. I think I'm in a similar situation in that I'm also in marketing and being able to be in this industry is one of the coolest things I've ever gotten to do because it is so impactful. And I agree with you. You know, you wake up in the morning and go " it's really not a cliche to say I am a part, maybe a small part, but I am playing a part in hopefully helping someone live a better, healthier, longer life. And my role is letting people know about what we do." And it's not engineering itself, but I do play a small role and that's really cool. Miguel Adao: Yeah, and it's not so small. I'm sure in the grand scheme of things, it's not so small a role. Lindsey Dinneen: There you go. Yeah. Well, I'm curious, I know your career has been really eclectic. Essentially, you've gotten to work in a lot of different industries and for different companies, and I would imagine that along the way you've picked up some good sort of leadership tips and tricks. Do you mind sharing your perspective on leadership? Miguel Adao: Yeah, sure. I think there's a big difference between being a leader and being a manager, right? That's a cliche of articles and other podcasts perhaps, but you don't want to be just a manager going through the motions and ticking off the boxes and the to-do list. But a leader actually brings folks along on a common vision. And by definition, folks will come to the party with a different point of view, a different perspective, a different vantage point that is influenced by their personality, by their upbringing, by their history, by their preferences and passions. And so you need to be respectful. And I must say I was not a good leader earlier in my career. I learned through the years, through good leaders of mine, by replicating and mirroring their behaviors and their attitudes that you need to be more empathetic and more understanding that not everybody, in fact, you don't want people to be exactly like you. I'm very outwardly enthusiastic. You can tell, right? I'm outwardly passionate and energetic. At first I used to think, "why aren't those folks equally rah, rah, rah?" They can be just as committed to the vision and even more so in their own way, and they're absolutely happy and passionate inside, and they don't have to demonstrate outwardly. So the extrovert versus introvert dynamic, et cetera. And so I've learned to appreciate that as a leader, what you want is people to rally behind and align with a vision and in their own way and in their own rhythm to follow along and to help build that. Not only follow along, but in many ways lead the leader, right? And help move the organization towards that common goal. I also like this notion that not everybody needs to agree, but everybody needs to align, right? So you don't always need to agree. How can you expect a larger team of dozens and hundreds and thousands of people to agree on everything? It's impossible and thankfully so, but as long as folks align, then they can go towards that common goal with give and take and compromise, et cetera. So I think the biggest role of a leader is to bring those folks along on that journey with a combination of resolve and focus but also empathy. The empathy part is what I learned later in my career cuz I was always, "come on, let's do it." If you're not doing this, get out of the boat and all those cliches, right? You're either with me or what is it? Or you're in front of me and if so, step out of the way or something like, and it's just so harsh and, and there can be cultural differences. There can be gender differences, that can be historical differences. And so, I've learned and I continue to learn more about empathetic and more kind of generous understanding of leadership. Because folks will contribute in, in different ways. I always find that there are fundamentally three major drivers in life, and I always go back to my personal life as a father, as a husband, as a son, as a brother. But also at work, there's three key senses or key drivers. One is a sense of purpose. You want to get up and you want to have a sense that what you're doing matters. We all want to feel that what we do matters, hence the cathedral analogy. Hence the, we're here to help people live longer lives that matters. So a sense of purpose. The other thing is a sense of achievement. A sense of accomplishment. So it's not just that kind of more ethereal sense of purpose and meaning to life and to what you do, but a sense of achievement. You're growing as a company. You're in percentages and in dollars and in market share and in number of customers and successful partnerships. So a sense of achievement that's the athletic kind of sports men like approach to not necessarily that you're competing and putting somebody else behind you, but that you're competing against yourself and you are getting better. And then I think the third big driver in life is sense of connection, of human connection. Right? And we are very collaborative and gregarious and tribal animals. And that's why the pandemic was so tough. It was tough on us. It was certainly tough when my kids and children in particular suffered with skipping a year and having to do it at home. I'm just saying being away from other human beings is tough. And so in this new day and age, especially post COVID, we're still very much doing Zooms and Teams and podcasting, which is great. But every chance I get in the car, like I told you I'm gonna do in about 15 minutes, and I drive an hour and a half to see somebody. I live in northern in Delmar, north of San Diego. I'm driving up to San Clemente in Orange County, just south of LA to meet somebody for 40 minute lunch, cuz I need that human connection. So yeah, sorry, another long elaborate answer to your question, but for me, leadership is about connecting. It's about giving folks a sense of purpose and meaning, and it's about allowing folks to also accomplish and celebrate accomplishments and achievements. Lindsey Dinneen: Yeah. Yeah. I love that. And so how do you continue to prioritize your own learning and growing as a leader? And perhaps, as a manager as well? Miguel Adao: Yeah, I'm very big on this. I love learning and I love teaching. I always try to remember when I lie down in bed at night, I'm trying to remember, "okay, what did I learn? What are two highlights from today? And, and what did I teach? What, is something that I share with somebody today that I think will also maybe improve their lives or their journeys?" And I do the same thing with my kids when I pick 'em up at school. Three highlights. "What did you learn today and how did you make your school day better for your teachers, for your classmates?" I've been doing this since they were kids, and I only speak Portugese with my kids. It's so funny. Because if I speak English with them, they'll just say, "Papa, that's weird. Don't do that." Even though they're 15 and 13. And one was born in England, the other was born here in San Diego. I only speak Portugese with them and so, I'm always prioritizing continued learning. I got a doctorate in business years ago in New York and in Paris, not because I need it for business. I only did it because I wanna publish and I want to teach one day. I'm very big on mentorship. I'm training four different people now in different companies, in different countries. I'm also mentoree, if that's the word. I like to mentor. I always seek out mentors, and right now I have two, one helping me on more strategic financial P&L, managing the financial health of a company, which is not something that I was ever that close to. And one is helping me more on those topics I mentioned earlier about empathy and about those emotional intelligence as well, which historically has been a little bit of a blind spot for me. So those are two areas. That one is more hard skills, financial skills, strategic, running a business. And the other is more about how to be a better, more empathetic human. And so that's something I do all the time. I also, whenever I can, I. I I do an executive program. I'm looking forward to doing a short program at Stanford University up in the Bay Area soon. And it's great to, to be able to do these programs, to be around like-minded individuals or maybe even unlike-minded individuals, but folks who also are looking to improve themselves and, and learn regardless of age. I'm 55, but I still want to learn as much as when I was 25. And just as I like to learn, I like to teach, so I love to present at different events and also mentor, as I said, I'm advising different entrepreneurs on their organizations as well when I have the time and the opportunity. So, yeah, continued learning both ways is a must, otherwise, you're a bike, and a bike if it stops moving, it falls over. Lindsey Dinneen: I love that. Yes. What a perfect illustration. Thank you for that. My next question ties into that actually pretty well, so I'm happy about this. So for fun, imagine someone were to offer you a million dollars to teach a masterclass on anything you want. It doesn't have to be in your industry, but it could be. What would you choose to teach and why? Miguel Adao: For a million dollars I can do anything at all, I'll make it up as I go along. Lindsey Dinneen: Right, right, right. Miguel Adao: We'll use ChatGPT to really learn about it 15 minutes before the masterclass. Lindsey Dinneen: Oh my gosh. Miguel Adao: But I probably wouldn't be as knowledgeable and therefore not as passionate about it, and they wouldn't want to give me the full pay for the events. No, but on the professional side, the more corporate side, I'm passionate about marketing, about helping organizations, helping my organization move from awareness to consideration, to preference to purchase. And I feel that I'm very comfortable talking about this theme of growing brand awareness and generating leads and pipeline, and ultimately, like we were talking about, storytelling, helping folks come along on that journey with you so that you were saying the right thing to the right person at the right time and the right particular need, whether it's a B to C consumer need or a B to B kind of business need. And so I can talk about marketing in all its different aspects and tactics and vehicles till the cows come home, but nobody would pay even $10,000 for that cuz there's a lot of knowledgeable people who know a lot more about that than I do. One area that I find I'm equally passionate more on the personal side, but that it touches obviously businesses and corporations and organizations as well, it's a combination of international intercultural experiences. Having lived in nine countries, speaking five languages, and having been exposed-- I've visited about 65 countries. I actually took the time to count one day. I've understood that actually the world, as diverse as it is, at the end of the day, everybody wants the same thing, right? It's just in a different way, in a different language, in a different approach, but everybody just wants to live a meaningful life. I'm not even gonna say happy life because happiness is relative, but a meaningful life, and they want to give their children or their loved ones the opportunity to do so as well. And so I'm, I've always been very big on inclusion and diversity, not so much from the kind of catchphrases, which are so topical today and can generate all kinds of emotions, both positive and negative, but more from the point of view that from an early age I moved around the world. I had to learn different languages. I have to learn different habits and different attitudes. And so I find that I adapt myself easily to who you mentioned, different industries and different types of organizations from a Fortune 10 company to a small boutique engineering services firm. So that's something I would love to teach a masterclass about how to adapt to different scenarios and certainly in terms of moving abroad, my friends and colleagues always check in with me if they're either visiting a place or moving to a place, what are some tips and tricks? So that's something I'm very passionate about, international and intercultural experiences. Lindsey Dinneen: Oh, I love that. Well, and that is so cool too, because of your background , like you said, you have had such cool opportunities to, to travel to different places and experience different things. So I really think that adaptability is such a good skill to learn. I can say that from personal experiences as somebody whose natural inclination is towards the more sort of routine driven, you know, learning to adapt and be flexible is so important. Yeah, Okay. What is the one thing you wish to be remembered for after you leave this world? Miguel Adao: I'm never gonna leave this world. I'm immortal. Lindsey Dinneen: Alright. Miguel Adao: Yeah. It's, it's so stupid, isn't it? We come to this existence. We live 80, if we're lucky, 90 years, and then we're gone. It can't be, it can't be. When we were in our twenties and thirties, we think we're gonna live forever. And then certainly as friends and elderly parents or relatives leave this world too, you realize, "yeah, this not, this is, this gig is not gonna last forever." I do want to be remembered as more than anything, as a good father and a good husband, and a good son, and a good brother. I'm not always, as those relatives would happily testify. I'm not always living up to my promise and my aspiration, but that's certainly my aspiration to be remembered as a good parent and husband above all, but also is a good friend and a good son and brother. That's, that's kind of the journey in the here and now that I'm on at all times. And so I try to remind myself in moments of stress, anxiety, sleeplessness, whatever, try to remember, this is your ultimate goal. What is the right behavior and the right thought, the right action for the moment. Also, just more generically with Voler Systems, the company that I work for, that helps organizations build their medical devices and their wearable devices. And we talked about this at the beginning, how I'm so happy that I work for a company that's making organizations better so they can make their patients better. I want to leave Voler Systems better than when I arrived. Just as every other company that I worked for, I wanted to leave the company and the team as the organization, the department, better than when I arrived. And I think that's my summary is to just leave this place, quote unquote place, whatever the place is, a company, a city, a community, a planet, better than when I first got there. That's, that's my legacy. Now I am far from this, but certainly it doesn't hurt to have a wish and a desire and an aspiration, kind of a north star to help guide. I fall down time and time again in this goal, but, but it's still my goal. I'm not letting go of it. Lindsey Dinneen: Yeah. Oh, I love that though. I, I love the perspective. In fact, I don't think I've heard anybody else say it quite like you did in terms of, if you have a goal and it's your north star, and this is how you wanna be remembered-- when you're feeling not at your best, you still have something to look at and go, "you know what, here's my ultimate goal." So here are the behaviors or the things I should say or not say to help get you closer to that goal. I think that's a beautiful way to put it. So it's not this aspirational idea that feels somewhat insurmountable or even unquantifiable. But instead you're doing tiny steps, tiny decisions make a big difference. So I love that. Miguel Adao: Absolutely. Everyone should have a North Star. Everybody should have an ultimate goal, both in their personal, family, professional, financial, romantic, religious, spiritual, whatever. Everyone should have a goal and then you have many goals and many objectives to get there. And the line from here to that goal, to that north star is never a straight line. It's a zigzag. Sometimes it goes backwards. Sometimes it stalls for two years. But you should always be aspiring to get there. And so if you have a goal, aspirational and unreachable but still possibly reachable, then it's gonna keep you motivated and focused. And you will make mistakes and as you will invariably, cuz we're human, but you'll learn from it. And at least one thing, you can rest easy in knowing that at least that North Star does not change. Lindsey Dinneen: Yes. Great advice. Thank you. And then final question, what is one thing that makes you smile every time you see or think about it? Miguel Adao: Oh, that's so easy. My kids and my wife, they crack me up. They're the three most incredible people I've ever met. And yeah, and it's just so interesting-- for those listeners who have kids-- you had this little baby that you shaped and molded and pretty soon that baby becomes an actual human being with thoughts and opinions and perspectives and intelligence and humor and wit, and some of it does not match what you say. And you're like, "where's this coming from?" And it's like, oh, I'm in awe. So, yeah, Olivia and Nico, and Lindy that's who makes me smile the most every day. And I, I live a blessed life because of them. Lindsey Dinneen: Oh, I love that. What a great answer. Miguel Adao: They'll like it too when they hear the recording. Lindsey Dinneen: Yeah. Miguel Adao: Awkward. Lindsey Dinneen: Nice. Well, this has been an amazing conversation. I'm so thankful that you joined us today, and I just really appreciate learning more about your background and your experience and your passion. And so I really appreciate your time, and we're honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational and safe environment. That was your choice of charity to support and I am just so thankful that you chose that one. So, thank you again so much. This has been amazing. Miguel Adao: I loved it. Thank you so much. Thank you for that charitable contribution as well. And thanks for the engagement, Lindsey. I really enjoyed it. Let's do it again next week, shall we? Lindsey Dinneen: Yeah, there you go. Absolutely. Well, thank you again. We just wish you continued success as you work to change lives for a better world. And thanks also to our listeners for tuning in and if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two, and we will catch you next time.  The Leading Difference podcast is brought to you by Velentium. Velentium is a contract design and manufacturing firm specializing in the development, production and post-market support of diagnostic and therapeutic active medical devices, including implantables and wearables for neuromodulation and other class three indications. Velentium's core competencies include electrical design, mechanical design, embedded software, mobile apps, contract manufacturing, embedded cybersecurity, OT cybersecurity, systems engineering, human factors and usability, and automated test systems. Velentium works with clients worldwide from startups seeking seed funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Description:During the Houston leg of our True Quality Roadshow series, we had the opportunity to sit down with Dan Purvis, CEO of Velentium and author of "28 Days to Save The World." Dan tells the story of how his company weathered the early days of startup life, and how the pandemic - which took so many companies down - turned out to be the springboard that tested the culture that Dan and his co-founder had molded from the very beginning.If you're not familiar with our True Quality Roadshow - you should definitely check it out! It's a free half-day event at one of 6 cities across the world. Links below!Some of the highlights include:The role Velentium played in upscaling the production of ventilators during the pandemic - this was a significant achievement and showcases Velentiums leadership, collaboration, and company responsiveness during this worldwide crisis.Real-life challenges faced by companies, especially dramatic stories like the purchase of parts without a PO and the personal involvement of the leadership, and paint a vivid picture of commitment and dedication.The central theme of a company's mission ("We exist to change lives for a better world") and how it guides its decisions is foundational and deeply impactful.The pivotal role that company culture plays, even when compared to strategic planning.The long-term vision of a company, and we emphasize that while actions and technologies change, the core mission remains constant.The decisions Dan was faced with, such as how (or if!) to pay employees during a crisis, and we highlight the ethical considerations a company has to make, and how to stay aligned with a company's core values.The emphasis on finding clients to fund growth rather than relying on investors - this is not only pragmatic advice for startups but also provides a unique perspective on business growth.Quote:"Because as a leader, if you don't clearly know where you're headed, it's really hard to get a bunch of people to follow you. And I don't want people to follow me. I want them to race me up the mountain, which is the one that we've all decided to ascend together."Reference Links:Dan Purvis LinkedIn28 Days to Save The World bookEtienne Nichols LinkedInTrue Quality RoadshowVelentiumTexas Medical Center for Innovation

Zoe Lalji is a junior at UT Austin studying neuroscience with a minor in entrepreneurship on a pre-med track, and she is working to make virtual reality accessible to ALS patients. In this episode, she discusses what it was like when her dad was diagnosed with ALS and how that changed the trajectory of her career, her work with advancing virtual reality technology to better support patients' lives, and how hardship has developed an essential self-awareness.   Guest links: https://www.linkedin.com/in/zoe-lalji/ Charity supported: ALS Heroes Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editor: Tim Oliphant Producer: Velentium   SHOW TRANSCRIPT Episode 010 - Zoe Lalji Lindsey Dinneen: Hi, I'm Lindsey with Velentium and I'm talking with MedTech industry leaders on how they change lives for a better world. Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello and welcome to The Leading Difference. I'm your host Lindsey, and I am so excited to introduce you to my guest today, Zoe Lalji. Zoe is a junior at UT Austin studying neuroscience with a minor in entrepreneurship on a pre-med track. Her passion for neuroscience began when her father was diagnosed with a Amyotrophic Lateral Sclerosis (ALS) in 2017. And since then, she has been constantly searching for ways to improve his quality of life and expand his avenues of connection with the world around him. As part of this work, she is working to make virtual reality accessible to ALS patients and other highly disabled populations as a way to provide them with autonomy in the form of novel experiences and immersive activities that they're unable to engage in physically. Zoe, oh my gosh, thank you so very much for joining us. I am just so very delighted that you're here and I just can't wait to hear more about your story and your background. But first, thank you just so much for being here. Zoe Lalji: Aw. Thank you, Lindsey. Thank you so much for inviting me. It's awesome to be a part of this great podcast you have. Lindsey Dinneen: Awesome. Well, I was just wondering if you wouldn't mind starting by just telling us a little bit about yourself and your background and what led you to what you're doing now. Zoe Lalji: Sure. So, right now I'm a junior at UT Austin and I'm studying neuroscience on a pre-med track and minoring in entrepreneurship. And as far as what kind of got me to where I'm at and-- I've been passionate about medicine for as long as I can remember. Both of my parents are in medicine. My dad was a dentist and my mom studied as a gynecologist and transferred into functional medicine. And they both had their own practices, so I've had that business background as well. But that all shifted, I would say, when my dad was diagnosed with ALS in 2017. And from there it was a pause button if you could say on on my entire scheme of my life, my plans. You know, I think with pre-meds there's a track that is a starting point and you have a series of events that are lined out for you until you reach medical school and get that MD. And that kind of stopped me in my tracks and made me reassess what was truly important because I had to spend a lot of time caring for my dad, caring for my family, and it definitely shifts your priorities and makes you reassess your life. And although, everything was still of in line with my values growing up, which was, I've always wanted to help people and that's what drew me to medicine. That's what I had really admired about my parents is the impact they had made on others' lives that were struggling, that had health conditions and needed guidance in that area of their lives. And I think watching my dad undergo one of those health conditions and just doing everything in my power to make it better for him in any way that I can. It just truly strengthened that core value for me. And I think when you're in pre-med, there's kind of a tendency to get tunnel vision. And, kind of that check mark mentality where you go, "Do I have the grades? Do I have the volunteer hours, the extracurriculars," all that stuff. And I think, you lose sight of the why of medicine, until even after residency when you're actually in the field where you actually meet the patients and you actually you know, talk to the people that are struggling and realize how important it is. And until then, it's more about, memorizing facts and figuring out how the body works without really putting it into the context of the bigger picture. So I think studying medicine alongside actually understanding what it's like to be on the other side, on the patient perspective, was a real driver for me. I guess the turning point for me for where I really realized that making an impact for medical problems is where my heart really lies. Lindsey Dinneen: Yeah, that is such a powerful story, so thank you for sharing that. I was wondering if you would be willing to share a little bit more about ALS and how that affects people's lives. I know it's a very difficult disease, but just from your perspective, especially having experienced it and trying to help someone who is dealing with it-- I would just love to hear a little bit more about it. Zoe Lalji: Yeah, absolutely. So ALS is a neurodegenerative disease. It impacts the motor neurons in the body, which effectively causes people to lose their ability to walk, talk, move any part of their body and eventually breathe on their own. And it's a interesting disease in that there's not much known about the pathophysiology of it, in that like they don't know what causes it. They don't know how to even approach treatment. Only 10% of ALS cases have been found to be connected to a gene. And even then they haven't really found a way to reverse any of that. So it's a completely uncured disease, the treatment is very limited, in that there's maybe a few months of life expectancy increased by the treatment, but in contrast you get a lot of side effects from it, which effectively makes you pretty much zombified. You know, it's a lot of fatigue, a lot of nausea, and a lot of patients just opt not to do it because the quality of life is really reduced from just being on those treatments. And so it's just a hopeless disease. And when you're given that diagnosis and told that it's always fatal and there's nothing that really you can do, you just feel completely helpless. And then as you lose your agency over your body, your ability to do things on your own, that helplessness sort of grows and consumes you. It's a very difficult disease to be diagnosed with on the patient and the family. Lindsey Dinneen: Of course. Yeah. Well, and I know part of your work, something that you are doing right now is working to make virtual reality accessible to ALS patients. And I love this idea, and I would love if you would be willing to share more about this and what brought that idea about and where is it taking you. Zoe Lalji: Yeah, of course. I love talking about it. This idea came from just my desire and my constant searching for things to do with my dad or things to bring him happiness in his life, or greater quality of life. And it came about from actually an internship I had during my gap year, which I took before college. And I was at a startup accelerator and there was a XR lab in the accelerator where they had virtual reality headsets, and I had talked to the head of the lab and he let me use one of his headsets and I ended up using Google Earth on the headsets. And I don't know if you've ever used virtual reality, but for whoever has used it, it's very life like, like you actually feel like you're there. You feel like you're walking the streets of Rome or you're in, you're in Paris, or so many different places that you can just click a button and just be fully immersed there. And that's just Google Earth. There's so many other immersive scenarios that you can dive into in virtual reality. And with the immersion of the Metaverse and so many different concepts of the growing interest in virtual reality as a way to have a life outside of the physical life. And just from seeing that Google Earth scenario, immediately I thought, "Wow, this would be incredible for my dad." Because for patients that have all of these life support machines, when they lose their breathing, you have to get a surgery and you have to be basically connected to a machine that controls your breathing. And obviously with that, you can't travel, you can't get on a plane. And for many of these patients, like my dad, you have all these hopes of where you would like to travel one day, things you would like to do one day, and life just happens and you don't end up doing it. But you always think there's time. You always think, " Maybe when I retire, I'll go and travel the world." The common notion that people say. When something like this happens and puts your life in pause where you realize you're never gonna be able to travel again, or you're never gonna be able to skydive or bungee jump or do those bucket list things that you said that you would one day do. And like, even further than that, it's more the things that you used to do every day that sort of defined you, that sort of made you feel like-- for example, my dad would, for as long as I can remember, probably my earliest memory of him is him waking up every morning and going for a run. And he never missed a day. And it was so important to him, like being who he is and his day working out the way he wanted it to, that he had that run, he had to start his day off feeling like himself. And I feel like we all have those hobbies and habits that really all together define who we are. And when you get a disease, not only is it like you're losing all of those things all at once, you start to define yourself as your disease then, because there's nothing else really left. I think for me, virtual reality meant giving those back this semblance of who they once were that they've lost. I think we're all the sum of what we do every day and our dreams and hopes for the future. And when those are taken away, it's who are we really? And that's not even considering the communication that patients lose. So you can't even really express yourself either. So with that, it's like there's this huge disconnect with their identity and I, I just see VR as a way for these patients to enter the world where they don't have to be defined as their disability, where they can do everything that anyone else can in virtual reality. And the problem lies with the modes of interaction with the devices where VR right now has remote controls that you need to use to interact with the environment, and you have to walk around to see the full environment, which for all quadriplegics, there's no really way to do that. So I'm trying to make that aspect accessible for that population so that they can have access to those virtual life-like immersive experiences that can tie them to the things that they used to love or would love to do one day. Lindsey Dinneen: Yeah. So essentially taking some of the existing tech, but putting it into a new method of delivery, I suppose? So that folks who can't, like you said, walk or that can't necessarily interact through a series of controllers or something like that, would be able to still experience those wonderful, immersive things. Is that... Zoe Lalji: Yeah. Yeah, exactly. Lindsey Dinneen: Ok. Wow. Yeah. Oh my goodness. Okay. This is so exciting, just to hear all about this. I know that you are still pursuing medicine and then now you're also pursuing this sort of tech side of things. I understand the background of you coming into it and why, but how have you found these interactions? Have they played out easily? Has it been an odd transition, or how has that all worked out? Zoe Lalji: Yeah, as you can imagine, it's like I have two sort of big things that I love and I'm passionate about and they both take a lot of time and effort and energy. And to say the least, it has been difficult to prioritize one or the other and find the time in the day for both. What I love about medicine is that the hope that we can bring to the patient. I love the innovation of it. I love coming up with solutions that aren't out there, that for the patients like my dad that don't see hope in existing medicine. I wanna be the hope for those patients. And that's, that's how I feel right now. I, I know I will always love every aspect of medicine, but that's what really drives me is that notion of helping those people that are feeling the medicine has failed them, and providing them with unconventional solutions that maybe they didn't think to look for or didn't think that there was one, you know? I think that until there's a cure for some of these diseases, technology can bridge that gap of function and bring back what people have lost. And I've seen it, I've worked with Paradromics as a BCI company in Austin and that was my first exposure since developing my startup into the, the medical technology world. And they're just such a amazing team and they have such a noble cause that they're fighting for and they just wanna help people like my dad. And to be surrounded by people that want to do that and the technology and seeing how impactful it has the potential to be. It really inspired me, especially coming from such a hopeless diagnosis that we had, it really gave my family hope. It gave me hope, and that's the feeling I wanna give to other people. And so my plan right now is to finish out my pre-med prerequisites in college and take a gap year or two to really work on my startup, really work on things like put myself in different environments in the medical technology world, get more experience and really understand my passion and what I can offer to the field. And from there I'll really decide if an MD is the right path for me or if I want to go a different route to get a different degree, you know, and still work within medicine, but not maybe bedside and not maybe in a hospital and not maybe with direct patient care. So yeah, I think that's the route I'm thinking right now? Yeah that's the plan. Lindsey Dinneen: Yeah. That's a great plan. And I love, I love your willingness and your openness to explore and continue to evolve, perhaps, over time in terms of, when you go into a new path and you've had this set of expectations for yourself for a while, that this is where you were going to head. And then things change and I just think it's quite remarkable when someone like you who is obviously very talented, smart, multi-passionate, is able to pivot and say, " I love this aspect, but I also love this aspect and maybe I can do both in a really creative way." I think that's fantastic. Zoe Lalji: Yeah, I mean, it was such a difficult thing for me since I had wanted to do medicine my whole life. It was something that was so ingrained in who I thought I was. Everyone asks you when you meet them, like "What do you wanna do with your life? What are you majoring in? What's your path?" And always it's pre-med, ever since I was a kid, I'd say pre-med, and it's strange to change that. And I think what really helped me get there is my life has been so turbulent and I've had to really get used to things not being how I planned, you know? And like that with my dad's diagnosis, throwing us into a spiral. And then after that actually, the gap year itself was another event that I had not planned for. I had decided to take one because my dad really needed me, and I found in my value scope that really came first before anything else. And then it became a serendipitous decision because in December, after I had taken my gap year, my mom was diagnosed with breast cancer. And luckily she's cancer free now, but we had to go through chemo, radiation, surgery and I could not have dealt with that at college. I had to be home, I had to be with her. And somebody had to take care of my dad. Somebody had to help her keep everything together and keep herself together. And I think, that was probably one of my biggest teachers is that, things are gonna happen. You can't avoid change, and I think that was really difficult to realize that maybe my plan wasn't the right plan for me, and maybe I need to take a second and let myself sit in the ambiguous unknown, which is really uncomfortable, but sometimes it's necessary in order to figure out where you really belong. But yeah it's definitely not easy. I definitely have not figured everything out. It's definitely some days I'm like, I just want to go back to the known, it's so much easier. But yeah, I think it's just getting used to the unknown and getting used to change. Lindsey Dinneen: Yeah. Yeah. And kudos to you for that viewpoint. And I'm sure, I'm sure some days are easier than others. I certainly understand that. But seriously, kudos to you for being willing to adapt to changing circumstances that you didn't plan for and you wouldn't have wished for, but this is really amazing to me as to how you've taken something that is so incredibly difficult and challenging, but you've really embraced the challenge-- and maybe that was a long time in coming-- but you've embraced that challenge and then you're not just helping your own family, which is incredibly important, but you're doing work that's gonna help so many people. And I think that is just amazing. Thank you for doing what you're doing. Zoe Lalji: Absolutely. Like you said, it definitely was a long time of really a lot of self-awareness, a lot of self-work, to get to a place where I was ready to embrace it, like you said, like it's something that has been difficult, has been so trying on our family, so trying on my dad. And a lot of days I am like, why did this happen? And I feel a lot of grief and a lot of sadness and unwillingness to embrace it. But for the most part, I've reached a point where I've realized that this is something that we've come a long way from, and we try to make the best out of the situation and make every day as bright as we can, given everything. And that's all we really can do. And I think watching my dad overcome it himself has been just what has given me the strength I need to get out of that sort of pity, out of that grief of like, why me? Why has this happened? And anger because when you think about what ALS patients go through, it's like you just can't even imagine what it could be like to be in that position. And to watch my dad really take that in stride and be this ferocious warrior through it and keep fighting no matter what life throws at him. He's almost at six years since his diagnosis and he's still fighting and he's still finding a reason to smile every day. And when I think about that it reminds me that it's okay. If he can fight like he's been fighting, then we all have that strength in us and that's, I think, what inspires me to want to help people like him, to want to bring more light into others' lives that are going through what we've gone through. And I think it's our duty really. I think I've gotten a very unique experience to watch somebody rise from the ashes and learn from that and I think that hardship, it sucks, and I'm not gonna say it doesn't at all like it, it does suck. All of it sucks, but it's an opportunity to learn. It's an opportunity to grow and it's an opportunity to become the best version of yourself through it. And there's moments when you don't want to learn , you know, you just, "I'm done with the lessons," like "I've had enough!" I think at the end of the day, it's like everything that I am and everything that I've learned it's valuable, regardless of what I have to go through to get me here. It's who I am. And so I think the best thing I can do with that is use it as a way to empathize with others in a way to really understand what's needed and how to help people that go through similar things that I've seen with my dad. Lindsey Dinneen: Yeah. Yeah. That's absolutely beautiful. Well, I'm wondering is there a particular moment or perhaps series of moments that stands out to you because it clearly confirmed that this was the right career path for you, even though it's been a bit of a meandering one, a pivoting one. Is there any particular moment where you thought, "Okay, this is why I'm here." Zoe Lalji: Like you said, it's a lot of moments. I mean, I would say the first moment was definitely when my dad was diagnosed. But even then I didn't really make that shift of " I'm definitely gonna do this for the rest of my life." It was more of a shock where I realized this is something I really care about. But I think really working on my startup has been so empowering. And then also my internship at Paradromics. I think the main moment that recently has made me realize that kind of clarify what exactly about medicine really drives me is I was invited to speak at a brain computer interface conference at the Chamber of Commerce. And through that I met so many key players in the the ecosystem. And I spoke to a lot of them about what I was passionate about, what I was doing, my story. And it was remarkable to me that so many people really cared and it was so obvious that everyone genuinely cared about the patient and about helping that person. It wasn't about the product, it wasn't about the business. It was about how can we help people the best way that we can and how can we use the potential of this technology to really help people's lives. And I think that energy and being in that space of like people just wanting to help, that was just so new for me because I think when something happens like that, you feel so incredibly alone and nobody could ever really help you, and it's like there's no hope. And people can try to support you and they can try to take care of you, but there's no way that they can actually help. And then even from the medicine side, there really wasn't anything there. And to enter into a room where so many people were making things actively that could help, for me as a daughter of somebody that was going through it, it wasn't so impactful and it made me think what about for others that are like me or for others that are like my dad to be exposed to this world of increasing potential and technology. And I was like, this is where I wanna be. This is home. Lindsey Dinneen: Wow. Yeah. That is a very powerful story. Thank you for sharing that. I have been personally so inspired by people in the medtech industry and healthcare because, you know, you start talking to them and it's easy to see how much they care. It's like you said, it's not just about the product, it's not just about the business, it's not about making money, although everyone needs to to make a living but it's about truly helping people, and I think that's just one of the most inspiring things that I have personally gotten to witness by meeting truly remarkable people through this field. That makes sense to me that, that was a moment that stood out for you. Well, that's amazing. Well, I'm curious, so you're in a really interesting new phase. Yeah. And I, I'm curious as you continue to develop your startup and whatnot, how would you define leadership? Or what does leadership mean to you? Zoe Lalji: I think for me, and from my experience with it, leadership is really about empathy and understanding your team. And the analogy I would use is like a wolf pack. The leader of the wolf pack is always walking behind the pack and making sure nobody gets lost and making sure everybody has purpose and a destination. And I think that as a leader, it's your responsibility to make sure that the team is whole, in a way, where everybody on the team-- you understand them enough to know their strengths and to know their tendencies and set them up to succeed and set them up to benefit the full team and have everybody on the team feel like their strengths are building the team into the best version of itself. And I think having that ability to really understand people really qualifies someone as a great leader. And I, I would liken a leader to a mentor in a way, because it's not about you, if you're leading a team, your success is the team's success, right? And your goal is to inspire success in each of the individual people on the team so that the team can be greater than the sum of its parts. Because everyone's strengths play in a way that they add to each other and compliment each other. And I think from what I've found is that when people realize that you truly understand them and you see what really makes them unique, they're more willing to devote those strengths to whatever cause you're going for. And they're more attentive to the goals you place for the team, the end goal. And I think another thing that a leader really has to do is understand the why of the team and really show that or really demonstrate that to the team and align them under the same why. Because I think what makes a team really unique is their ability to align themselves under that goal and all fight for that goal together. I think those are two things that I find are really important in a leader. Lindsey Dinneen: Yeah, absolutely. Agreed. Yeah. So pivoting a little bit, just for some fun. Imagine someone were to offer you a million dollars to teach a masterclass on anything you want. It can be in your industry or something you're working on now, but doesn't necessarily have to be, what would you choose to teach and why? Zoe Lalji: Wow. That is a fun question. Wow. Okay. I think I would probably want to teach a class on self-awareness through hardship. I think that is one of the biggest things that I have struggled with especially when I think in my gap year was the biggest moment where I realized, I am really defining myself as a caregiver. I'm defining myself as someone that cares for others because I did that every day. And it was so difficult to have my own identity, to have my own sense of self, and I think that really finding that balance of what do I need to be the best version of myself and to do the best for others because of that. I think that journey for me of really finding what's important to me, reprioritizing, because I think moments like these shift your priorities so much. They shift your view of the world. They shift who you are. And to catch up with that is there's so much change going on in your life to keep a pulse on you and who you are, what you stand for, is so incredibly difficult. And I think if you're not careful and you're not placing importance on that, you become misaligned and you don't live in your true values. You don't live within your true values because you don't have that alignment within yourself. And I think, once you've gone through a phase where you've completely lost sight of that and it's a phenomena with caregivers that we tend to forget about ourselves completely. And we place focus on others, on the people we're caring for. And I think in my gap year with both of my parents needing me to be there for them, it made me feel like this is more important, right? Because before the diagnosis with my dad, my highest priority was always family. And caring for others and giving back was such a huge thing that had been instilled in me, and it's still a huge priority for me. But I never had to take care of myself. I never had to place importance on that because there was never a point where I was gasping for air and gasping for care. And I think it also just felt like I didn't know who I was anymore, and that's such a terrible place to be in. And that's why I can say that for, for patients that undergo this, it's that to a totally different extent, and that goes back to my VR project. But I've done so much, coming into college and really getting the space to put myself in different scenarios and see who I am.  I think that sitting with myself and taking that time and doing that work has really allowed me to be there better for my parents, be there better for my family, because I'm just more aligned. I'm more me. And being around my dad when I'm not even me is not helping him. He wants to spend time with me. I think when you neglect yourself, it's hard to be you, you know, it's hard to explain, but I think just having that alignment through something so pivotal in your life, something so earth shattering that happens to you, that kind of shifts who you are. And keeping track of that shift and keeping yourself in your care and treating yourself as a child, because you are. You have to nurture your inner child and really take care of that child and not think that child is perfect because they're not. And the thing about this particular class would be that I haven't figured it out. But I have done a lot of work and I would want to help people that are trying to navigate that because I feel like there's been a lot of trial and error and if I can help people in any way with my experience with it and what's worked for me, and how I went about figuring out what works for me, I think finding that balance within such a all-consuming situation and hardship, that I would wanna help people through that. That's been monumental for me in realizing that myself was important, in defining myself and being aware of myself and who I was. And so yeah, I think realizing that was important through all of this hardship. I think that's one of the biggest learning moments for me, and I'd really wanna share that. Lindsey Dinneen: Yeah. Yeah, absolutely. And like you said, there are so many people who are going through similar things that could really benefit from that. So that would be an amazing masterclass. So I'll look forward to that whenever that comes up. What is one thing you wish to be remembered for after you leave this world? Zoe Lalji: Honestly, I feel like my impact will be in the lives that I've impacted, and if I can be remembered as a friend, as an advocate, and as a mentor for those people, I would be fulfilled. I feel like I would just want to at least help one life that needs that guidance, you know, that feels so alone and feels so hopeless, to bring that small amount of hope, even if nothing at all. And I think where my fulfillment comes is that I want to help people like my dad, people like me, people that have been struggling, that can't find what way is up, which way is the light, either guide them or provide them with some semblance of hope. Or just be a friend, or just be support. Because coming from someone that's been there, coming from someone that can empathize and make them feel like, "Hey, you're not alone. It might feel lonely and it might suck, but you're not alone." Lindsey Dinneen: Yeah. Yes. Absolutely. That is very powerful. Final question, what is one thing that makes you smile every time you see or think about it? Zoe Lalji: Well, I think that one is easy because it's my dad. He's my inspiration. He has so much light within him that only comes from overcoming something like this. And his energy is just so incredible, and he is the reason I keep doing what I do. And I think also, the memories I have of him, the memories of him as my father when I was a kid and things that he used to do with me and things that just really showed that he loved me so much. And those memories that are just so sacred to me and every time I think about it, it's bittersweet, but it always makes me happy to remember what he means to me. Lindsey Dinneen: Yeah, absolutely. Well, Zoe, oh my gosh, you are so very inspirational. I would not wish the path that you have taken on you in the way that it has happened, but I just admire you so much for taking a very hard path, but making so much good come from it and embracing the light and embracing choosing to help others see that light and see hope in a difficult time. Gosh, I cannot wait to continue following your work and seeing what you do because I know you're gonna be impacting a lot of lives. Oh my gosh. Zoe Lalji: Thank you. Yeah, and I really loved being on your podcast. I loved talking to you. This form is amazing and I can't wait to see what other amazing speakers you get on here. Lindsey Dinneen: Awesome. Well, thank you, and we are so honored to be making a donation on your behalf as a thank you for your time today to your family's organization, which is ALS Heroes. This organization honors the heroes amongst us who have stared devastation in the face, only to say, "you do not define me." The organization hopes to guide those heroes in navigating their resources and provide them with hope in the midst of a seemingly hopeless disease. And I'm so excited to continue to learn more about the organization and how we can get involved. So thank you for bringing our attention to it, and thank you again for being here. We wish you continued success as you work to change lives for a better world. Zoe Lalji: Thank you so much, Lindsey. It's been a pleasure. Lindsey Dinneen: Absolutely, and thank you also to our listeners for tuning in. If you're feeling as inspired as I am right now, I would love it if you would share this episode with a colleague or two, continue to pass along the word, and we will catch you next time.  The Leading Difference podcast is brought to you by Velentium. Velentium is a contract design and manufacturing firm specializing in the development, production and post-market support of diagnostic and therapeutic active medical devices, including implantables and wearables for neuromodulation and other class three indications. Velentium's core competencies include electrical design, mechanical design, embedded software, mobile apps, contract manufacturing, embedded cybersecurity, OT cybersecurity, systems engineering, human factors and usability, and automated test systems. Velentium works with clients worldwide from startups seeking seed funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Today's entrepreneur has helped the blind see and the sick breathe. He overcame serious limitations to help people during the pandemic - and now he is here to tell us the story of his epic 28 days to save the world on The Business of You! Dan Purvis is a serial entrepreneur and the founder of six companies. He is the CEO and co-founder of Velentium, a professional engineering firm that specializes in the design and manufacturing of therapeutic and diagnostic active medical devices. He has 25 years of practical know-how in creating corporate environments that people want to work in and clients want to engage with. The theme throughout his professional and nonprofit endeavors has been an intense love for people, which led Dan to become a student of culture. Dan's passion is building things. His background is in automation, controls, and software. When working with people, he identifies possibilities for what they can accomplish. Dan Purvis is doing remarkable things. Velentium designs and develops plantable neurostimulator devices that change lives for a better world. One of the companies Velentium partners with is called Second Sight. Together, they help the blind see - using a special pair of glasses that senses light, the imagery is played on the wearer's optic nerve. At Velentium, what began as a two-person operation grew to a multimillion-dollar-firm within three years. From 2014 on, Velentium has averaged 50% annual growth year over year. Velentium has executed 1,500 projects in 15+ countries, working with over 100 clients. Velentium has recently been named to the 18th Annual Aggie 100™, honored as fastest-growing company. Rise to the occasion Velentium exists to change lives for a better world - and they stick to their promise to rise to the occasion when things get hard.  When Velentium scaled up and took on manufacturing, Dan was proud of their dedication and hard work. But nothing could have prepared him for what came next. When the pandemic hit, Dan realized that one of their partner companies was going to have to begin producing thousands more ventilators, at a rate they'd never been able to deliver before.  With his own family in mind, Dan decided to be part of the solution. He made some phone calls and specifically requested to fly from Houston to Seattle where the first COVID deaths had occurred - just in time for Ventech Systems' 8am morning meeting. In partnership with General motors, Ventech took the 100 units a month they were producing and turned it into 10,000 units a month in just 28 days. Radical transparency forges strong bonds When Velentium initially received the massive, record-breaking order from General Motors for thousands of ventilators, Dan Purvis turned it down. Everyone thought he was crazy.  Shocked, the purchasing department called him on the phone. So far, he had risen to every request and need they had - so why was he turning this one down? Dan was honest with them: He could not deliver what they were asking for, by the date they had requested. They asked him for a new date, but he still could not give a definitive answer.  After ramping up production to unprecedented speeds, Dan was still wary of making promises he could not follow through on. Essentially, he asked them to work with him. He would push his team as far as they could go and produce as much as they could - and he would promise to brief them daily on Velentium's progress.  While this was different from what General Motors had dealt with in the past, they appreciated Dan's transparency. He hired his own personal friends for their purchasing team, asked his employees to go above and beyond and still required that every ventilator be thoroughly tested. He wrote a book, 28 Days to Save the World, to tell the story of what it looks like when an entrepreneur has to rise to an extraordinary challenge, overcoming all obstacles.  Enjoy this world-changing conversation with Dan Purvis - about work culture, guiding principles, teamwork and courage. Quotes “We were a contract design and development house that is now a contract design, development and manufacturing house. It's really important for your listeners to know that as they get more and more successful in their entrepreneurial cycle, just understand that growth eats cash. The more you grow, the faster you grow, the less cash you'll have. With manufacturing, we can now finish the project, hand it into our manufacturing shop, and now we can have revenue for the life of the product that we just developed!” “Thinking as entrepreneurs: How do I get my business model into a place where there is perpetual repeatable revenue and I don't have to go through the whole sales effort again and again to keep revenue up?” “I could not have a time where it's your mom and my mom, and they both have COVID - but there's only one ventilator left. I thought, if we can make a difference in that, we need to. So I flew out there.” “We doubled the size of the company in about a week, and through that process, just stepped in over and over and over again. We ended up writing a book about it, 28 Days to Save the World. One of the things I say in that book is that you're going to have all-in moments that come across you in your career as an entrepreneur. In those moments, it is absolutely critical that you step in and volunteer yourself - why not me? Why not you? When it comes, you have to not just dip your toe in the water. You've got to cannonball. And we did.” “We had 120 people in what was a company of about 48…working 16 hours days, seven days a week. And then I called several of my friends who were all at home watching The Office reruns because they were bored, wondering what's going to happen with the world. I was like, Are you bored? They're like, I'm bored out of my mind. I was like, well, join our purchasing team!” “We wrote 28 Days to Save the World, to tell that story, but more importantly, to give entrepreneurs like your listeners a good, hard perspective of the culture. Work we have been doing for ten years is what enabled that story.” “At Valentium, we have four principles that govern all that we do: Our passion, honor, humble charisma, and the commitment to changing lives for a better world.” “When you say, how do you build culture? Know your principles.” Links mentioned in this episode: Visit the website for Velentium at https://www.velentium.com/  Purchase Dan's book, 28 Days to Save the World: https://www.amazon.com/28-Days-Save-World-Crafting/dp/1637741901  Follow Dan Purvis on LinkedIn at https://www.linkedin.com/in/dan-purvis-velentium/

Etienne Nichols is a mechanical engineer, PMP-certified project manager, the host of the Global Medical Device Podcast, and the builder of the Greenlight Guru MedTech Excellence Community. In this episode, he shares a plethora of advice and great stories, including why gratitude and curiosity matter so much, how writing helps you to identify what you truly believe, his passion for furthering the medtech industry, and how an article he read changed his life.  Guest links: https://www.greenlight.guru/podcast | https://www.greenlight.guru/etienne-nichols-thankyou | https://www.linkedin.com/in/etiennenichols/  Charity supported: Polaris Project Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editor: Tim Oliphant Producer: Velentium   SHOW TRANSCRIPT Episode 009 - Etienne Nichols Lindsey Dinneen: Hi, I'm Lindsey with Velentium and I'm talking with MedTech industry leaders on how they change lives for a better world. Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello and welcome to The Leading Difference. I'm your host Lindsey, and I am excited to introduce you to my guest today, Etienne Nichols. Etienne is a mechanical engineer and PMP certified project manager with a wealth of experience in the medical device industry. He's worked with Fortune 500 and startup medical device companies and has taught classes on quality management systems and design controls for Regulatory Affairs Professional Society and American Society for Quality. He is a frequent speaker at MedTech conferences, the host of the Global Medical Device Podcast, and the builder of the MedTech Excellence Community. Thank you so very much for joining us, Etienne. I'm so excited to have you here on this show today. Welcome. Etienne Nichols: Thank you. I'm excited to be here as well. I'm super pumped to be with you today. Lindsey Dinneen: Awesome. Well, I would love, if you wouldn't mind starting by just telling us a little bit about yourself and your background and how you got to where you are now. Etienne Nichols: Sure. I guess if I was to break down as simple as possible, I'm the host of the Global Medical Device Podcast, and I say that partly because we just interviewed Dan Purvis, the CEO of Velentium on his book, "28 Days to Save the World." Loved that, but, anyway, just had to throw that out there because I'm just such a big fan of you guys as well. Okay. To your question, specifically, my background, the word background can meet a lot of things. I just finished a book called "Livewired" by David Eagleman. He's a neuroscientist at Stanford. He basically says, our brains aren't so much observers of reality, but filters. So we filter out our past, we hone in on certain things. Okay? I say all that to say when I think of background, I imagine a picture of Mona Lisa, what's in the background? You think Mona Lisa, what's in the background? Only things that matter to Da Vinci. So I'd like to tell you a quick story. It might not seem super relevant, but this is a story of kind of help shape who I am. When I was in my early twenties, I thought I was in love, but it turned out that it wasn't meant to be. So as an early 20 something without a fully grown prefrontal cortex, I did what any self-respecting Oklahoman would do. I signed up for Terry Don West School of Bull Riding. Terry was a world champion bull rider 1985 to 2003, and he had a school outside in Henrietta, Oklahoma. So I went there. I was the only city kid there. After a few rides, like I literally got on multiple bulls and I got on one where it laid down in the shoot, it was bucking around and laid down in the shoot and it, it was dark down there. And my brain immediately said, "abort mission, jump outta here, jump outta the shoot." And I jumped out and I was terrified. Terry ran over, he yanked me by the collar, he stuck his gloved finger in my face, and he said, "you never ever ever get off a bull in the shoot." And so I, I'd say that story to say, when I think about background, that was a pivotal moment in my life when I thought, you never give up. You know, no matter how dark or scary it is, you never give up. So that, that was one of the things that before I was engineer, that was one of the pivotal moments.  I'll talk about my real background, I guess that's more traditional. I'm a mechanical engineer by trade. Before coming to MedTech, I worked in aerospace, the steel industry, so both regulated and unregulated. I'm gonna close my window because I actually have a rooster right outside my window. Lindsey Dinneen: I've been enjoying him. Etienne Nichols: But I've worked in manufacturing regulatory. I actually got my project management, professional certification on a regulatory project product development. Finally was a project manager of a drug delivery combination product. So, all of those things before I came to Greenlight Guru, which is where I am now. I've worked with dozens of companies to help them set up and implement their quality management system. And so as I mentioned before now, I manage the Global Medical Device Podcast. So it's been a really fun ride. Lindsey Dinneen: Awesome. Yeah. And a very eclectic ride. It sounds like you have come at this in a very unique way. Okay. I would love to hear a little bit more about your story on joining Greenlight Guru, because I recently read a post on LinkedIn about it. I just thought, "wow, what a great story." I'd love if you'd share that with us. Etienne Nichols: Sure. This was several years ago. I was working as a project manager for a drug delivery combination product company. I walked into the VP of Engineering's office. He and I were talking about some things that were going on, and I thought, I need to do a little bit of research. I went back to my computer. I started looking for an article, and that was when I first stumbled across Greenlight Guru. I came across the article, "DHF Versus DMR Versus DHR." It's a helpful article because FDA and their acronyms, if you're familiar with those. So after reading that article, I did what anyone would do. You know, you reach out to the author, thank them for their writing. And so I, I reached out to Jesseca Lyons who was the author on LinkedIn, and I told her I really appreciated the things that she had written, and she just responded, "yeah, you're welcome." The very next day she posted, "Hey, we had a great quarter last quarter, and by the way, we're hiring" and I thought "hiring?" So I clicked on the link and it looked really interesting and I just applied on the whim. I was not looking for a new job. I wasn't interested in getting a new job, but I wanted to learn more about this person and their company. And after my first interview with her, she literally put a Zoom meeting on my calendar that afternoon. Three days later I had an interview with Tom Rish. Four or five days later, I had an interview with Fran Cruz, who was the VP of Customer Success at the time. And I basically had an offer in less than 10 days, I I believe.  So, Jessica and I joke about that article changing my life a little bit, but it's a really good article. But it's been a fantastic ride and I've really enjoyed my time at Greenlight Guru. And I'll say one other thing, it felt like a big risk at the time to move because I was in a great position. I loved the company I was working for. I really respected the CEO. But after looking at this company, it felt like a risk, but the more I thought about it, it was so in line with what I really loved doing: content creation, interacting with customers directly, and the potential to get on stage and speak on the podcast or at conferences. I felt like it was a bigger risk not to take this job. So this is something that I would throw out to some of the listeners is you may be facing different career steps and there's always a risk no matter what you do, but you always have to think about the risk of not taking a risk. And I think that's something we sometimes forget. So I dunno if that answered your question. That's the story as least as it's coming to me at the moment. Lindsey Dinneen: No, That's a great answer. Yeah, I love those collisions, I like to call them. All of a sudden, things work out, but it takes intention, right? You read an article and then you reached out to the author and that led to a series of events, and here you are. But, I just love when those, those kinds of things happen. Those stories are my favorite. Etienne Nichols: Yeah. It makes me think-- oh, I'm probably gonna butcher this-- but the definition of luck is when preparation meets opportunity. Lindsey Dinneen: Yes. Etienne Nichols: And I think if you're always preparing, you, you may or may not be lucky. The opportunity may or may not arise, but when they do, you know, you almost have an obligation to take that sometimes. Lindsey Dinneen: Absolutely agree. Yeah. A theme that I have picked up on from following your work on LinkedIn and whatnot is gratitude. And I would love if you would share just a little bit maybe about your philosophy behind it, because it seems like something that you often express gratitude, whether it's to the author of an article that you appreciated or it's to an interviewee that had a particularly inspiring thing to share. I just have noticed that theme throughout your work, and I would just love to hear your perspective on it. Etienne Nichols: Wow. I actually got like little chills when you were saying that because I don't think anybody, nobody's ever mentioned that or called that out. So I'm glad that's showing through, for sure. I'm really thankful, I'm thankful that's showing through. It's funny, let me rewind to a period in my career that I thought this was one of the toughest parts of my career. It, looking back, it was one of the toughest. I was in a situation where I was leading a project that if this project did not succeed, many, probably dozens of people would be laid off because the company wouldn't be able to support them if this project didn't succeed. That was my perception. And I think even looking back, I think it's accurate. So, I was really stressed at the time. We were working 60 plus hours a week, me and my team, And during that time, I honestly thought a lot about giving up. I never gave up. I told my wife, no matter how hard it is, I've gotta finish this. And then, if it's still difficult, after we're done, we're gonna move on. And that is what happened. We brought the project to fruition and moved on. But during that time, I remember standing outside a conference room and I stared at an empty whiteboard and I looked at that whiteboard and I thought someone should put something in there. So I put just a question. "What is your definition of success?" I believe that was the first question. A few days later, I walked by again and lots of people had answered that with their different definitions, and I thought, huh? I took a picture, went home, and I wrote a memo. I said, "what is your definition of success? This is what you said." I went back to work and I sent this out to, I don't know, 20 different people. I didn't know who had answered on the whiteboard and I wrote a lot of these different things and people kept telling me you know, appreciate you translating our words into this memo. Just kinda your giving it your own thoughts. By the time I left that company, I had over a hundred people who I was, you know sending a Monday memo to, and I learned somewhere along the way that people don't mind getting a little bit of encouragement. During that time, the way I was able to get through the stress was every morning I would write that Monday memo. I would think about those things people were saying, and I would try to focus, what am I really grateful about these people? And that's really what helped me get through. So, that was kind of a circuitous way of answering your question, so I'd like to be a little bit more succinct here in the, my last couple phrases here. There is, there's a lot of scarcity in the world, but gratitude really shows you what you have. When you start looking and comparing your life to other people's, it's easy to wish you had this, wish you had that. When you're grateful for what you have, you start recognizing all the things that you do have. And so it's more of an abundance mindset. So that's been my philosophy. I believe gratitude is at the heart of of an abundance mindset. Lindsey Dinneen: Yes. I love that. Thank you for sharing that. And that story is pretty awesome. So was that maybe the start of your content creation journey? Etienne Nichols: Yeah, I do think that. Oh,, if you'll let me go through another story, which is Lindsey Dinneen: Yes, please. Etienne Nichols: When it comes to content creation I'm a big believer in writing and having a writing practice of some sort. So, to answer your question just directly, yes. that was the beginning and I learned the value of writing every morning. In fact, at that time I was very disciplined. I have three kids now, I'm not quite as disciplined. I would get up at 4:45 every morning. I would go work out and then I would stop at a coffee shop on my way to work. I would write for 30 minutes, and then I would go to work. That was before the pandemic, coffee shops closed. And it was before kids and all these different things, but that's when I started writing. Fast forward to Greenlight Guru. I was working with different customers and I was loving what I was doing. Occasionally I would post on LinkedIn just a long form article about, this is something I learned about, I don't know 21 CFR part 820.40 document controls. Why do you need to show a Rev A to Rev B? Why do you justify those changes? All these different things. I've just wrote an article about that, and I would do that every now and then. Well, while I was in that position here at the company at Greenlight Guru, the CMO, Nick Tippmann reached out to me and said, "Hey, we're thinking about building a community and we want you to build the community. I've been watching what you post on LinkedIn." So this is a guy I'd never met before. He's within my company, but he saw what I was doing on LinkedIn, the content creation. At the same time, the founder of the company, Jon Speer reached out to me and said, "Hey, I've watched some of the things you wrote on LinkedIn. Wondered if you'd be interested to be a co-host on the podcast." And so these are two separate situations happening at the same time because of the content creation. Now I'd been writing for years up until this point. And I'll tell you one more thing about writing is it helps you identify what you truly believe, what you actually think. You may think something, but once you write it out, you may change your mind or tweak it slightly. And so that really helps. And so I've been doing this for multiple years and it got me to a point where two different people approached me and I was able to accept that, and it's been really fun. Lindsey Dinneen: Yeah. I love that story. When you had the opportunity to do the podcast, was that something that you felt immediately comfortable taking on? Was that something that took a little bit of a learning curve, or how did that work for you? Etienne Nichols: The way I would describe it was terror. I had never met the founder of this company. And not only was I meeting the founder, we were interviewing the best in the field-- people like Mike Drews or your CEO, Dan Purvis. Every time I saw those names on my calendar, the pit of my stomach would ball up and I'd go through some breathing exercises, do some squats, whatever. And it's okay, we could do that. But, when you get scared like that, to me, you, you have to qualify it a little bit, but a certain amount of that fear, to me says this is the right direction for me. And the same thing happened at multiple points in my career that sort of confirmed this is the right thing and that little bit of fear is one of 'em. You can look at it as fear, but you can also be excitement because I'm reaching beyond my grasp, and if I keep reaching, I'll grow and I can actually reach this thing. So that's how I looked at that. Lindsey Dinneen: Yeah. Yeah. I love that. I was once told by a friend that she felt that whenever you were nervous it was because you cared. And so use that nervous energy to do a really good job because it can be harnessed, right? That fear, that, that nervousness, but it's not a bad thing, it's just along for the ride. It's there to help give you a little extra boost and that's okay. And I've always kinda liked that. Etienne Nichols: So I'm curious about you because I love talking to other podcasters, so I just, if we could flip the script just for a minute. I'm curious how you handle that nervousness or is, are there any specific things you do? Lindsey Dinneen: That is a great question. Yes, I still do get nervous. And it does depend on the situation, but I think one thing that I have learned is that being yourself, being just normal and natural and a little vulnerable and a little bit not polished is actually a lot more relatable to people than being perfect. And I'm not perfect. My interviews will never be perfect, but I can do my best and I can be me. And the more that I embrace that, the more comfortable I am. Etienne Nichols: Oh, yeah. I think that's great. The one thing that I I can't remember who told me this but curiosity-- you talk about like what is the opposite of love? Is it hate? Some people may say hate, but I actually think it's indifference. Indifference to me is the opposite of love. So what's the opposite of cowardice or being afraid? The opposite of that isn't courage, because you have to be afraid in order to have courage. To me, the opposite of being afraid is curiosity. Someone may disagree with me, but that's the way I banish fear is, man, be really curious. " Why did I react that way? Or what are they really trying to tell me?" And instead of thinking, oh, this person's title is this, and this, I'm like, "what are they actually saying?" This is really interesting. So that's how I look at that. Lindsey Dinneen: I love that. That's great advice too, just in general because curiosity allows you to explore and exploration is always a success, right? It doesn't lead to failure, it's just a way to learn more about the world around you. Etienne Nichols: Absolutely. Lindsey Dinneen: Well, okay, so you have mentioned that there have been a couple of moments along your journey that I guess confirmed to you that this is the right path. But I'm curious, specifically in the medtech industry, what is it that drives you, that gives you that passion to continue doing what you're doing? Etienne Nichols: Yeah, I can tell you a couple different things. So the spark I would say happened when I was in college. I broke my arm and it was a go-karting accident. And I went to school with arm in a cast. But before I got my arm in a cast, the guy's name was Garrett Watts, the hand doctor who put me back together, and he knew I was a mechanical engineering student. He talked to me about the Synthes DePuy, I don't can never pronounce that word, but the little piece that was going to be placed into my arm with different screws and talked about the physics of it really fascinated me. I thought, man, as a mechanical engineer, I could contribute to this industry. That would be great. That was a spark. Then when I met my wife, she has had a pacemaker since she was 11. So, I've seen her through multiple surgeries to get new pacemakers. And every time I see that, it's man, I am so thankful somebody developed this medical device. There have been other times when I had to watch a loved one go back to the OR, and just talking to the surgeons afterwards and learning about the things that they have to go through. I want their life to be easy. I want them to be able to do their job efficiently. And so I really am passionate about the medtech industry for those reasons. You know, I love all of the things that go into engineering. I will never be the best at those things. And I kind of had to realize that somewhere along the way. The people who are really the best at anything are the people who do it for a living and also do it for a hobby. And those are the people you want in your life in different roles leading technically and things like that. But when it comes to MedTech, I realize I could be passionate about this product because I know the end user is going to be truly affected by this. Not only some unknown person, it could even be my wife, my son, anybody I love could be affected by this. To me, MedTech is really personal, and that's what confirmed this industry. For different roles, I see myself as, I just want to help the industry and so whatever role I can be in, whether that's mechanical engineer or a project manager, or a regulatory consultant or a podcaster. However I can help further the industry to where we work more efficiently and more streamlined in a way that produces safe and effective medical devices. That's the role I want to be in, whatever that role is. Lindsey Dinneen: Yeah. Yeah, absolutely. You've mentioned having opportunities to be in leadership roles, to lead teams, and we've had that discussion in regards to gratitude specifically, but I'm curious, how would you define leadership? Or what does it mean to you? Etienne Nichols: That's a good question. And so two things come to mind. And they're actually both books, and so you don't have time to quote an entire book, but all my best thoughts came from someone else. And so even that's a line from someone. But the two books I could think of first one is "Leaders Eat Last," I believe it's by Simon Sinek. And it's really the idea that leaders are meant to build others up. In fact, actually, a third book comes to mind. That's "28 Days to Save the World" by your CEO dan Pervis. That's a fantastic book. I really recommend that one as well. And I'm not just saying that because it's your, it's your guy. He covers so much ground in that book. It really was something that you almost need to read multiple times. But the second book that I recommend is "Captain Class" by Sam Walker. So he talked about the captains of teams. So usually when we think of a leader, we might think of the CEO, we might think of the executive team, and those certainly are incredibly important. But the "Captain Class" by Sam Walker, he's actually a sports journalist, if I'm remembering all of this correctly. He analyzed all of the great sports dynasties, not just someone who wins one off, but he gave certain parameters as to what he would define as a team sport and a team and a dynasty, and all those different things at the beginning of his book. But he talks about " what do they have in common?" And he looked at the coaches, he looked at the budget, he looked at the manager, he looked at the location, all these different things. And the thing that he found that was really consistent across all of these dynasties was the captain of the team. It might not be the best player. It might not be the person who's most outspoken, but it's that person who brings a certain energy and can recognize when things are going sideways or things are changing, and he somehow tweaks the team in such a way that they can reorient and get back on track. So you want your best player shooting hoops, shooting those free throws. They don't have to lead, they just do what they do. Put your best players in the positions where they can excel. But the captain, like I said, they may not be the best player. They may not be the best person on the team, but they're the person who's kinda like the glue, who gels everybody together. And so those two different concepts are what I think of a real good leader. Number one, leaders eating last, and the second one being that glue who's able to look at a bird's eye view and determine what direction we need to go in, what attitude adjustment needs to happen. I'll give you one more little anecdote that you may have heard before, say you have a bunch of people working their way through a woods cutting with axes trying to get through the woods. The manager is the one running around saying, "Hey, do you have the right ax? Do you need this sharpen? Do you need this? Let's help you out." It's still a servant role, but the leader is the one who climbs the tree and looks up and says, "Hey guys, I think we need to go in this direction." So that's the leader in my mind. Lindsey Dinneen: Yeah. So the visionary and the person who is the cheerleader and motivator and helps bring people together towards a vision. Etienne Nichols: Yeah, so my, my dad actually told me something once that he probably got this from someone else, I'm not sure, but he said, " you know, Etienne, a leader without followers is just a guy taking a walk." And some of us are just taking a walk, but a leader is someone who people are willing to follow too. So yeah, there's lots of different facets. It's a good question. Lindsey Dinneen: Yeah. So you mentioned curiosity before, which I think is a really important theme. And so I'm wondering how that plays into your continued growing and learning as a leader yourself. Obviously, you have had a bunch of different roles even within the industry and through various companies and I'm sure each one of them has prompted you to learn and grow in different ways. So, how do you continue to prioritize that these days? Etienne Nichols: Yeah, that's a good question. I've gotta speak to your question about curiosity first. In every role that I've been in, one of the things that's really important to me is to understand how this role that I'm working in interacts with every other role in the organization. I'll give you a quick anecdotal story, I guess, for that. I was at one company where they put me in a cubicle that was right outside the break room, and that's a terrible idea. You do not put an engineer right outside the break room. The people had to walk out of the break room and either turn left or right or go straight into my cubicle. Since I was new, they told me that my cubicle was cursed. Nobody had managed to be there for more than three months. And nobody knew why. It's just cursed. I'm like, okay. Well, I figured out pretty quick why. It's because I started writing down how many people came into my cubicle to say hi to me, and it was in the 30 to 50 people a day and I was not getting things done. Just a few minutes with each person, and that becomes hours a day. So I realized quickly that this is a problem or an opportunity. And so I tried to treat it like an opportunity. The next engineer who came into my desk or came into my cubicle, I said, "Hey, can you help me with this thing I'm working on my spreadsheet?" And they said, "oh yeah, you just do this, and this." And my 15 minute task turned into a one minute task. And so that happened multiple times. Pretty soon I was getting more things done than pretty much anyone else on my row. And so being curious about what that person knew was really important to me. And I realized it clicked in that role early on in my career. And I said, man, I need to learn what everybody in the company does. And so I started actually making a running list of who is everyone in the company and who do I know. And I put a check mark next to their name and I said, "okay, I gotta meet this person and find out what they know. Meet this person, find out what they know." It wasn't all me. When I came to that company, this is actually a really fantastic practice that this manufacturing company had done. They gave me a list of every machine in the entire company. And so we had multiple buildings, you know, out there. And they said your first job is to find every machine, learn who runs it and what product it touches and how that machine interacts with that product. And that's a big homework assignment. So if I wasn't interested, that would've been hard to accomplish. So, between my situation being outside the break room and my forced interest in the manufacturing floor, I decided to make it a personal goal of mine to meet everyone in the company and to learn exactly what they do, a little bit selfishly, to see if I could make my job a little bit easier to learn what they knew and so forth. And so that really helped. And that really reinforced the importance of curiosity. Lindsey Dinneen: That's a great story and I'm sure you looking back are also quite aware, obviously of how things evolved in your own career. But it's fun to hear it from an outside perspective and go, okay, I see how certain things that you did, maybe just because you were curious, led you to be in a position now where you are comfortable-- maybe still get nervous-- but in general comfortable talking to all sorts of different people cuz hey, you were just going around meeting everybody, learning what they do anyway. Etienne Nichols: Oh yeah. It's crazy to look back. When we look back, we can connect the dots easily, but when you're in that soup, you're in the moment you're like, oh, my life is a mess. You're not really exactly sure. But yeah, yeah, you nailed it, that's true. Lindsey Dinneen: Yeah. And then nowadays your continued learning and growing as a leader in the medtech industry? Yeah. Etienne Nichols: So the way I answer that, the way I prioritize it is it's true. We all, we only have so much time in a day. It's difficult to get those things in. I try to double dip as much as possible. And so what I mean by that is, let me give an example. The best way to learn something is to teach it, right? When I was approached, I looked at myself, I said, "Etienne, you don't have what it takes to do these things." And that was just my honest assessment of myself. But I said, but I'm gonna take this on and I'm going to get what it takes. And so, after I was in the role a little bit, I started looking at the different conferences I could potentially go to learn more about these things. And you might make the argument, okay, going to a conference. That's a continuing improvement, right? You can learn there. Well, that wasn't good enough for me. So, I have a specific story about this. There's a conference called CMX. It's the number one conference for community building, I believe. I found that and I thought, "okay, I want my company to send me to this conference, but I don't just want them to send me, I want to speak on stage, even though I've been in community for only a few months." I'm going to come up with a problem that I've faced and a problem I've solved, and I'm going to write a proposal for me to speak at this conference. So I sent it in. I sent my proposal in and they wisely said, "no, but you can moderate a panel." I thought, "okay, well that's good enough." So I went to the industry. I moderated the panel, but because I was speaking and I was gonna be on stage, I now had access to all of the voices in the industry who were speaking. So I sent them all messages, tried to socialize with them prior to going to that event. And I now have dozens and dozens of really valuable connections in the industry to that specific subset of an industry. So that's one example. Another example I'd give is double dipping. I gotta describe something real quick. So there's something that I learned early on. Have you ever heard of " The Seven Spoke Wheel of Life" by Zig Ziglar? Lindsey Dinneen: I don't know that I have. Etienne Nichols: Oh, man, you've got to check that out. Lindsey Dinneen: Okay. Etienne Nichols: So I learned this in college, lets see if I can remember them all. But see, he has the Seven Spoke Wheel of Life. Essentially, what he says is there's seven spokes. You have family, career, intellectual, social, financial, physical and spiritual. I think I did it unless I repeated something. So all seven of those spokes essentially make up your life. If you have a broken spoke, you have a flat tire, just think of it that way. So I looked at that and I said, "okay, well, I go running with different people and we usually chat about the same old thing." So I said, I'm gonna start using this Seven Spoke Wheel of Life as much as possible. And so the next guy who I went running with, I told him about the seven spokes. I said, why don't we pick a different spoke every time? We'll just talk about that while we run our 10 mile run or whatever it is. And so we would do that and we'd cover more ground. And so when I say double dip as much as possible it's making those different spokes cross over each other. So that was, let's say, intellectual. Maybe I'm gonna meet with some engineers to go running. So that's a physical thing. That's an intellectual thing. It's a social thing. I have now met three needs in one interaction. Or maybe I'll go to a coffee shop in the morning. I have a book club that I meet with every week to discuss a book that we're talking about. So there's a social interaction, there's our intellectual interaction and it forces me to be reading. If you can double dip, even the podcast-- I get to practice my public speaking. I get to extend my career perhaps. But also meet with people like you, Lindsey, and other people in the industry, and it's really fun. So double dip as much as possible and don't feel bad about it. Lindsey Dinneen: Oh, that's great advice. I really like that. I like, I like the double dip because that's a little better than multitasking, right? Because we're actually not wired to do that. But I really like your idea of combining a couple of different things together for the win. So. Etienne Nichols: Yeah, and I love that categorization. It helps me anyway to kinda have that seven spokes, so you kind of differentiate for yourselves. Okay. This truly is doing multiple things. it's beneficial for me anyway. Lindsey Dinneen: Yeah, absolutely. Just pivoting a little bit, just for fun. Imagine someone were to offer you a million dollars to teach a masterclass on anything you want, doesn't necessarily have to be in your industry, but it could be. What would you choose to teach and why? Etienne Nichols: A million dollars! Oh, okay. Well, So the thing that comes to mind for me is listening and I know it's a soft skill. And if I thought long enough, maybe I could come along something technical and specific to medtech. But for right now, listening comes to mind. So few people really listen. And sometimes I struggle with this myself, but most of the time we're just waiting for our turn to talk and you've actually done a really good job. I'm actually pretty impressed with your capability and your listening. It's really cool, Lindsey.  But a lot of times when we think we're listening, we're coming up with that next thing to say, but instead if we're able to ditch those lines and listen with your whole body, your whole mind, your whole soul, make this person in front of you the most important person in your life. That changes everything because what I've realized is people are willing to give me the amount of attention I give them and not a whole lot more. And so, you've really gotta learn to listen to, to really succeed. Lindsey Dinneen: Yeah. I love that. And actually to your point, I'm curious how do you manage that as a podcast host and when you're moderating panels and things like that because part of your job does entail a certain amount of preparation. So how do you balance the two? Because you, you wanna get to the questions that are important for you, but then you also, of course, wanna be actively listening so that you can have a real conversation. Have you found a good way to balance that? Etienne Nichols: It is really difficult. If anyone ever says moderating a panel or moderating a podcast is easy, I don't know that they really know what they're talking about. It takes a lot of focus. I go back to a quote, I guess, I think it's, was it Eisenhower who says "planning is everything, plans are nothing." And when you go to a, an interview like that or a panel is a good example. I'm glad you mentioned that. When you go to a panel, you probably have a list of questions that you want to get to, but it's hard for our brains to remember every one of those little points that we want to ask. So if you instead focus on the overarching theme that you want to cover, and this is the advice I give people, is focus on the overarching theme and then when you're talking to those people, you have your initial question, you'll ask that question and they'll answer, really listen, because most likely the gold is somewhere in that question that they asked. I'll see if I can think of a example. If they're answering a question about the time that they, took a company public and it was pretty stressful at the time. They managed to get it public. They signed all the papers and now they're retired, but they're really excited because now they're advising other people. I'm like, okay, there's something stressful. I heard them say that. I wanna know, what did your wife think when you decided to take that public? What did your executive team, or what did the people who work for you think? I may have a list of questions, but I really want to dive in and just treat it like a conversation keeping in mind the overarching theme of the panel. So I dunno if that answers your question, but that's how I approach it. Lindsey Dinneen: Yeah, I really like that. And something that came to mind as you were talking about the overarching theme was sort of in tandem to that-- maybe the idea of what do you hope the audience will gain from it? So if you have that perspective of I want the audience to feel inspired or I want them to know more about this particular topic by the end or whatever, then that can help guide the conversation too. Especially if it doesn't go quite the way you anticipated. Etienne Nichols: Yes. I love that you said inspired or I want to make them feel inspired because that's a really good point. I told someone this recently, man, everything on the panel you could probably Google. Sometimes there's really good tidbits, but for example, Dan Purvis and I, we did the the interview a few weeks ago and it was a fantastic interview and you could go and read his book and maybe get a lot of the anecdotes that he told us about. But you're not gonna get the feeling of passion for the industry or excitement for the future and all these things. And so, that's really what a lot of these live events will give you. It gives you a feeling to move you forward and we think, "oh, that's wishy-washy. We're technical, we're engineers," but you can't forget that we're humans. We're driven in a certain way. And so these interactions that make our job easier, a lot of that is softer skills or softer experiences and not necessarily hard technical things. As important as those are, you have to have the things that pull you forward. So I love that you mentioned that inspiring the audience and things like that. Lindsey Dinneen: Yeah, definitely. So speaking of inspiration, I suppose, what is the one thing you wish to be remembered for after you leave this world? Etienne Nichols: I think it's interesting that we even want to be remembered. When I'd step outside myself and look at myself, I'm like, why do you wanna be remembered? But you do. And so I can't really get rid of that. That's fine. So when I think about that, the answer I think I would have is the strength of my kids. I heard someone say this once. See if I can remember exactly how it goes. I want my son to be the strongest man at my funeral. It's my job to make that happen. When I think of being remembered, I think about being remembered through my kids. There's another ancient writing that goes something like, "like arrows in the hands of a warrior so are the children of one's youth." So being a good dad, that's probably the most important thing to me in my life. Lindsey Dinneen: Yeah, absolutely. And then final question, what is one thing that makes you smile every time you see or think about it? Etienne Nichols: Oh, It would have to be my daughter. She's 13 months old now, and if a rainbow could become a person, that person would be Darcy, my daughter. Lindsey Dinneen: That's wonderful. I love it. Oh my gosh. Thank you so very, very much for joining me today. This has been so much fun. Speaking of inspiration: lots of it, lots of great advice and your stories are fantastic. So thank you so much for sharing all of that with us. Etienne Nichols: Absolutely. Yeah. Thank you so much, Lindsey. I really appreciate you inviting me onto the podcast and excited to work together in the future. Lindsey Dinneen: Yeah, and we are honored to be making a donation on your behalf as a thank you for your time today to the Polaris Project, which is a non-governmental organization that works to combat and prevent sex and labor trafficking in North America. So I really appreciate you choosing that organization to support and just again, thank you so much. We just wish you continued success as you work to change lives for a better world. Etienne Nichols: You're so welcome. Take care. Lindsey Dinneen: Of course, and thank you also to our listeners for tuning in and if you're feeling as inspired as I am right now, I'd love it if you share this episode with a colleague or two and we will catch you next time.  The Leading Difference podcast is brought to you by Velentium. Velentium is a contract design and manufacturing firm specializing in the development, production and post-market support of diagnostic and therapeutic active medical devices, including implantables and wearables for neuromodulation and other class three indications. Velentium's core competencies include electrical design, mechanical design, embedded software, mobile apps, contract manufacturing, embedded cybersecurity, OT cybersecurity, systems engineering, human factors and usability, and automated test systems. Velentium works with clients worldwide from startups seeking seed funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Diane Bouis is a scientist-turned-startup leader and ecosystem connector with MedTech Innovator. In this episode, she shares how accelerator programs can make a big difference in the success of a medtech startup, her passion for mentoring scientists leaving academia, her unique ability to "switch" easily and effectively, and why she self-identifies as a "nerd in a suit." Guest links: https://medtechinnovator.org/ | https://www.linkedin.com/in/diane-bouis/ Charity supported: Save the Children Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editor: Tim Oliphant Producer: Velentium   SHOW TRANSCRIPT Episode 008 - Diane Bouis Lindsey Dinneen: Hi, I'm Lindsey with Velentium and I'm talking with MedTech industry leaders on how they change lives for a better world. Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello and welcome to the Leading Difference Podcast. I'm your host Lindsey, and I am so excited to introduce to you as my guest today, Diane Bouis. Diane is a scientist turned startup leader and ecosystem connector. She is the director of the US Program of MedTech Innovator, which is the largest accelerator for MedTech in the world. Diane, thank you so much for being here. I'm so excited you're here. Diane Bouis: I'm very excited to be here. Thank you for the invitation. Lindsey Dinneen: Absolutely. Well, I would love if you would just start by introducing us to you. Let us know a little bit about yourself and your background, kind of what led you to this industry and this field. Diane Bouis: Thanks for that question. Quite a few years ago. I told my parents at age 14 that I wanted to become a medical scientist and solve HIV/ AIDS, and cancer. No lack of ambition there. And I'll say unfortunately, I have not managed to solve either of these two problems so far. But I became a medical scientist, did my PhD in the Netherlands and then moved to the US right after my PhD to do a postdoc at University of Michigan. So, classic scientist trajectory, you do a PhD, you go to the US to do a postdoc and then you go back to Europe to become a professor. I'm originally from France and so, so any European country would've done, but really loved it, loved the research that I was doing in cardiovascular research and stuck around and eventually left academic research by way of an MBA. And discovered startups and discovered the fact that science and business folks don't always speak the same language. And I often jokingly describe it as the dichotomy between the scientists who look at the business people just as suits, and the business people who look at the scientists as nerds. And so I always say, I'm a nerd in a suit. I am business and science, and that's an excellent place to be. So my motivation remains to save lives, but it has broadened a little bit from two very specific diseases to saving and improving lives across the industry. Lindsey Dinneen: Oh, I love that. And oh my goodness. Yeah, you were definitely ambitious right from the get-go. I love it. I love it. And I love how your path has changed along the way, but you have clearly stayed open to all sorts of different opportunities and that has led you to experience some really amazing things, and like you said, you get to be a part of a lot of different discoveries and innovations and I think that's awesome. Well, thanks for telling us a little bit about your background. I am curious what you do now and how has that all come about? Diane Bouis: So I'll take a step back and tell you a little bit about MedTech Innovator. And I appreciate that you mentioned in your introduction. We're the largest accelerator for MedTech in the world. And MedTech Innovator has been around for a decade. I am rather new into my job. I'm less than a year with the organization, so I don't really have merit in building this fantastic organization. However, we run an accelerator program between the month of June and October. But taking that a step back to, to really where we are and what we do. We work with startups in MedTech and we define that as medical devices and healthcare IT. And we work with startups in MedTech between the seed stage and the series C, so that's a very broad swath, I would say our cohorts are roughly split in two between the earlier stages, so seed and series A. And the later stages, B and C. And we work closely with our strategic partners. MedTech Innovator is a nonprofit, and so we're not asking for equity, we're not asking folks to relocate. We are really the conduit to great partners and mentors. And that is with great names in the industry and as well as investors. Basically, we connect you to people who can help you get to the next level. That's what an accelerator does, and we do it uniquely in MedTech. And so I run the US program. That is the largest one, the flagship one. But I'd be remiss if I didn't mention the other two programs. We have an Asia-Pacific program that Sakeena Tan runs out of Singapore. And we have a BioTools program that Ayelet Marom runs. She's also in LA and so, specifically BioTools and MedTech innovator, we're in the same geography. We are working very closely together as we are recruiting startups. BioTools is adjacent and between the two programs, sometimes the applications overlap. MedTech is anything that impacts patients, whereas the BioTools application could be a startup that is in research tools or that is in platform technologies for personalized medicine. So those are the three programs. That's that's really where we play. And I personally run the West program, which means finding great startups, soliciting applications from great startups, and then facilitating some of the review. We have fantastic partners and reviewers and judges as well as then creating the program that really helps those companies accelerate. Lindsey Dinneen: Thank you so much for that background, because that does provide a lot of context for our conversation and obviously for the amazing work that MedTech Innovator does and I can personally say from having attended just one event last year, that included some of the MTI companies that are part of this experience-- oh my goodness. I mean, it was so inspiring to hear from these inventors who are coming up with just amazing, life-changing devices. And wow, those stories must inspire you every day. Diane Bouis: I agree. I always say I got into the business to save lives and it is incredibly motivating to work with people who are in that same business: saving or improving lives. And the inventions and technologies are fascinating and so are the people who work with them. And so I get to work with the greatest people. Lindsey Dinneen: Well, so you mentioned a little bit when you were talking about your background, and I think this is a great thing to touch on, there can, not always, but there can often be a little bit of a disconnect between what you referred to as suits versus, did you say nerds or geeks? Diane Bouis: I said nerds. I self-identify as a nerd. Lindsey Dinneen: Okay, perfect. So what have you found that has really helped bridge the gap between those two, especially for, say these brilliant scientists and nerds, who, you know, have fantastic ideas, but maybe don't have as much of the business background to really bring those ideas to market , to actually market them, so that people can actually know that they exist and things. So, how has your interconnectedness of those two elements played out through your own career and as you are now in this role. Diane Bouis: There's a couple of things that come to mind. One: it is very hard for all of us to know what we don't know. And so if I know, I don't know something, I can seek knowledge. I can ask someone questions. I can go and find a book and read it. I can get a course. If I don't know that I don't know, something, that's much harder. And so, every single one of us can strive to uncover the unknown unknowns. And one of the ways to do that is to surround yourself with people who are somewhat different from you and who know different things than you. And so to come back to the inventor who has found a really fascinating phenomenon or who has invented a really interesting device but may not know a good way to get it into the world, to bring it into the market. In many ways, it's a matter of asking questions because when I meet someone for the first time, I don't know if they have perhaps previously held commercialization positions and know what they're talking about or not. And so asking questions: " who would use this? Do you know what the need is out there?" Depending on the situation and the level of comfort, it crystallizes to "who cares?" but saying, "who cares?" can feel adversarial. And so you've gotta pick your words wisely there. But asking questions and learning and than bringing up the concept of the unknown unknowns to simply put that out there, you, and I say you in this case, to an inventor, maybe the world leader in a particular area of science. And while during my days in the lab, I was definitely very conversant in my particular scientific niche, I also recognize that there are areas of science that I'm not that conversant about, and so everybody understands that they're very good at something and maybe less good at other things. And so just opening that conversation. Once we both agree, maybe you don't quite know how to get to market, then we can have the conversation around, "okay, well what are the resources available to you here and elsewhere to learn about this and to learn what you might be missing?" And then sometimes I can connect someone to resources, accelerators are a good one, but very often there's grant funding opportunities. There are local economic development entities. There are other entrepreneurs. There are entrepreneurial organizations from whom you might be able to learn a thing or two. We learn a lot from our peers and so even recognizing that you may need a peer group can be helpful. Lindsey Dinneen: Yeah. Yeah, absolutely. Thank you for that. So I'm curious, is there a particular moment that stands out to you because it clearly confirmed that this was the right career for you? Diane Bouis: I will say for me, there have been several interesting moments of change and getting into accelerators was not an obvious choice. While a lot of our world was was slowing down due to the pandemic, I had the opportunity to help someone I know design a curriculum for a digital health accelerator and had a ton of fun with that. That person knew that I've done programming. I co-founded a healthcare hackathon nonprofit. I've run events that help healthcare innovators in many different ways. And so they knew that I could help with that and and so I did. And I had a ton of fun designing a curriculum and running a curriculum. And while that was supposed to be a one-off during the pandemic in my spare time, I recognized I had a ton of fun with it. And I think whenever, in our careers we realize, I'm doing something that is valuable, that people appreciate and that I'm really enjoying, ask yourself, is there a job where I can do more of that or where I can do that all the time? And so I, I did what any reasonable person would do. I Googled top "10 medtech accelerators." Lo and behold, as you would imagine the top result was MedTech Innovator and I had run across some social media posts from MedTech Innovator before so it wasn't completely new, but I thought, "gee, that seems to be the right organization for me, let me reach out to them." And I'm very fortunate that a little over a year later, here I am. Lindsey Dinneen: Oh, I love that. What a great story. Do more of what you love when you can. Well, now obviously you have held a variety of different positions throughout your career, and it sounds like leadership has been a running thread, and so I'm curious, how would you define leadership or what does leadership mean to you? Diane Bouis: I would say leadership is defining a shared goal and aligning one's self and one's actions to it, which then in turn also means aligning a team towards those goals. And so when the goals are very clear, we can all move in unison towards them. A friend of mine once said, "just hire great people and get out of the way." And I think that is correct, but that only works if you have a great shared vision where everybody intuitively knows we're all moving in this direction, therefore this is the correct action even if I don't have the opportunity to ask you for direct feedback. And so give a lot of feedback in the beginning and then align to that shared vision that we're all pursuing. So, to summarize, set a shared vision and and then go after it together. Lindsey Dinneen: Oh, I love that. Very good. Yeah. And then what would be your best piece of advice for someone who maybe is early on in their career or is looking for the next step or whatnot, then they're interested in obtaining a leadership role within the medtech industry. What would you say to someone who might be wanting to do that? Diane Bouis: The advice I always give to my mentees is, of course, get your name out there. And so say yes to opportunities, even if it's not immediately obvious how they will benefit you and in ways that are somewhat transparently self-serving. When you have opportunities to, for example, participate in ecosystem events. When you can give advice to a budding startup, when you have an opportunity to be on a panel or in a speaking role at a conference, those are ways in which you can showcase your leadership in the field, showcase the leadership, thought leadership of your organization. That's one of the ways a rising manager, a rising person in our industry really can get out there. I would also highly recommend joining professional organizations and joining a committee. It is about giving back to the industry, but it is also about the other members of that committee. We are at the same time, a large industry as well as an industry small enough where you will encounter people again, maybe not next year, but maybe 2, 3, 5 years from now. And so, be a good citizen and involve yourself in things that are directly useful to you professionally, as well as not immediately useful to you, but perhaps useful to others. It's a great practice to grow oneself, but it's also leading by example for the people you work with. Just because telling people to do something is one, doing it is the other. People will observe what you do and what you prioritize and will make similar choices. Lindsey Dinneen: I love that. So, being a model, even if you are not yet in that position, but you are modeling the kinds of behavior that a good leader would want to exude anyway, so you can start doing that no matter what your job title is or where you are in your career. Diane Bouis: I would agree especially , with the complexities in the MedTech industry, nobody knows everything and we sometimes don't know what other people know. And so, speaking up when you have knowledge that could benefit someone, is really helpful. I consider that as I still mentor scientists leaving academia. I consider that one of the biggest differences between academia and the business world. In academia, you only speak up when you truly know. In the business world, nobody has time for that, to wait until the last person might have gotten enough data to make a call. And so if you know something, speak up. There's opportunity to be heard. And if you have something to contribute, it would be a mistake to not contribute it. Together, we can truly make a bigger difference than individually. Lindsey Dinneen: Yes. I love that advice. And I'm curious because you've mentioned you don't know what you don't know, adopting kind of a growth mindset and your own continuous learning and growing as a person. And I'm curious, as a leader, how do you prioritize your own learning and growing? Diane Bouis: While I was still a scientist and contemplating getting an MBA, a friend of mine who had walked that path from PhD to MBA before suggested spending 10 to 20% of one's time on personal growth and personal growth is sometimes giving back to the ecosystem. So sometimes that's giving somebody else career advice, but also spending time reading something that is not directly pertinent to your work. And so, it can be a newsletter from a different industry. It can be a scientific article, it can be a book. Often concepts from other industries can really help. And so, making sure that you take the time to grow yourself beyond just the ability to make interesting small talk at the next conference, but really thinking about what the future looks like, the future of our industry, but your personal future and the world can lead to choices of books, of courses, of where is the world going to be in 10 years, and where do I want to be in 10 years? And the answers to those questions should lead to a couple of steps to do every week, every month to keep growing. Lindsey Dinneen: Yes. Good advice. Thank you for sharing that. So for fun, imagine someone were to offer you a million dollars to teach a masterclass on anything you want. It doesn't have to be in your industry. It absolutely could be if you'd like, what would you choose to teach and why? Diane Bouis: I think, I would enjoy designing a masterclass in switching, and that might sound funny at first, but I have come to realize that is something that I happen to be quite good at and that not everybody else is good at. And switching for me can be switching between different industries. I've worked industry agnostic almost for the past decade while I come from the biomedical sector. And so I can bring an analogy out of agricultural technology or petroleum refining that someone in the medical industry may not have thought about. So that's switching in terms of switching industries. But far more personally, I happen to be a speaker of several languages. I speak both French and German to my parents, and that's where the accent is from that, that usually tricks somebody up. So it's worth saying. And what I've realized since a very young age is many people speak languages quite well. I happen to be really good at switching and translating in real time, and so I can keep up a conversation with 2, 3, 4 people in 2, 3, 4 different languages simultaneously. And so switching is often the hard part and learning and teaching to really seamlessly go from one language to another or one area of science or a business to another, I think is a useful skill more of us could have. Now I would need at least a month to actually really design that course, but it would be a ton of fun. I think I'd enjoy that. Lindsey Dinneen: Yeah. Oh, well I love that. That sounds like a wonderful skill to have. It peaked my curiosity a little bit because you had mentioned before that transition and for yourself and helping other people with a transition from say, the academic world for scientists or whoever to transition out of that. And I'm wondering for yourself or the people that you mentor, and this is a huge, I would think, shift for anyone. I mean, I've undergone various shifts as well, and it's sometimes it kind of impacts your identity. Do you find that's a component, that is something that you would talk about, say in your masterclass or even that you talk about in real life in your mentoring other people? Is that a component of it that you have found has been something to consider as you're making these life changes, these switches? Diane Bouis: Absolutely. That's a really great question. We spend the largest part of our waking time at work, and so what we do professionally largely defines us, for better or worse, and that also means that if we make substantial changes that will almost invariably impact how we see ourselves and how others see us. And both of those, how we see ourselves and how others see us have a big impact on our psyche and how we perform in what we do. So it's important to be cognizant of that. And for me, that first step was leaving academic science. I'd been a scientist for a decade, and so "I am a scientist" stops being true when you're an MBA student. So then you're a former scientist, but you haven't quite arrived to, what am I now? And so, so, how do you define yourself? And I will often say "I'm lean startup" and working with startups is far more who I am these days and how I define myself. So helping startups is really the nutshell. But how we define ourselves is important. And it's important to spend some time on it because what we signal to the world, and especially people earlier in their careers, where you have been is evident from your resume, but who you want to be your next step is yours to tell. And so that is really important. And the past informs the future, but doesn't automatically define it. Lindsey Dinneen: Yeah. Yeah, absolutely. I think that's a subject that is not talked about a lot. But it is so important because it is, it's a huge component of making those switches and being able to make those switches effectively in terms of how you see yourself and like you said, how others see you. It does play a role and so it's nice to have honest conversations about that and, " let's think through that. Let's work through that." Thank you for sharing that. What is the one thing you wish to be remembered for after you leave this world? Diane Bouis: I would say probably for caring. I care deeply and so most people and organizations and startups I interact with I cannot help but care, but that also often means I lean in and I, I truly do want to help sometimes in unconventional ways. Startups are unconventional, so caring. I think if there's one thing to be remembered for, it would be caring. Lindsey Dinneen: I love that. That is a wonderful thing to be remembered for. And then final question. What is one thing that makes you smile every time you see or think about it? Diane Bouis: I would say what fills me with joy and therefore makes me smile-- but it is a more profound feeling of joy-- it is good people coming out of the woodwork when asked. That is the very definition of community. Somebody needs help and asks, and the community comes to the rescue. I am part of a number of local communities, obviously with MedTech Innovator, for example, we just had a call earlier today with a 2022 cohort. So those are folks, most of them I haven't seen since October. And about 25 or so of the startups, of the 50 startups that went through the cohort, showed up just for updates. But then there's always someone who has a question as in, "Hey, have you heard of this conference? Hey, do you know someone who can help with this? Hey, do you know about this?" And there's always somebody who has an answer. And so it's community. It is asking for help and receiving help. That'll make my day every day of the week. Lindsey Dinneen: Oh, I love that. What a great answer. I just absolutely love that. Well, I just wanna say thank you so, so very much for your time today. Thank you for sharing your advice, your insight a little bit more about MedTech Innovator and everything that they provide to this industry. I just really appreciate it. We are very honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational, and safe environment. That was Diane's choice of an organization to support. And I just wanna say thank you so very much for doing that, Diane, and we just wish you continued success as you work to change lives for a better world. So thank you again so much for being here today. Diane Bouis: Thank you very much for having me. Lindsey Dinneen: Of course, and thank you also to our listeners for tuning in and if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two, and we will catch you next time. The Leading Difference podcast is brought to you by Velentium. Velentium is a contract design and manufacturing firm specializing in the development, production and post-market support of diagnostic and therapeutic active medical devices, including implantables and wearables for neuromodulation and other class three indications. Velentium's core competencies include electrical design, mechanical design, embedded software, mobile apps, contract manufacturing, embedded cybersecurity, OT cybersecurity, systems engineering, human factors and usability, and automated test systems. Velentium works with clients worldwide from startups seeking seed funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

In this podcast episode Dan Purvis, CEO and co-founder of Velentium, shares his experience of building 30,000 ventilators in just 28 days during the COVID-19 pandemic. He emphasizes the importance of taking risks and volunteering oneself in times of crisis, and the significance of having a strong company culture that puts people and results before profit. Dan's book, "28 Days to Save the World: Crafting Your Culture to Be Ready for Anything," provides insights on how to build a resilient company culture.   Dan also discusses the importance of practicing culture in a company, rather than just having it as a set of values on a website or conference room wall. He emphasizes the importance of principles-based leadership and creating a "you decide" culture, where employees are empowered to make decisions based on the company's principles and values. Dan encourages listeners to pursue simplicity in their lives, and to ask themselves if they have reached it. If not, then they need to simplify their lives.   Dan Purvis is the CEO and co-founder of Velentium, a professional engineering firm that specializes in the design and manufacturing of therapeutic and diagnostic active medical devices. A serial entrepreneur and the founder of six companies, Dan has fulfilled his dream of building a company that puts culture before function, results before profit. “Improving lives for a better world” is more than a slogan; it means Velentium's staff doing meaningful work on clients' behalf so they can bring life-changing products to market. By building a company that talented people want to work for and other companies want to work with, Dan has led Velentium to become a world-class engineering firm averaging 50% year-over-year growth.Dan has more than 25 years of experience in software, electronics, test systems, and medical devices. He earned a B.S. in Electrical Engineering from Texas A&M University and a Jones Scholar MBA from the Jones School of Business at Rice University. He is the coauthor of 28 Days to Save the World: Crafting Your Culture to be Ready for Anything.   You can connect with Dan via Linkedin: https://www.linkedin.com/company/velentium   Whether you are a C-Suite Leader of today or tomorrow, take charge of your career with confidence and leverage the insights of The CEO's Compass: Your Guide to Get Back on Track.  To learn more about The CEO's Compass, you can get your copy here: https://amzn.to/3AKiflR    Other episodes you'll enjoy: C-Suite Goal Setting: How To Create A Roadmap For Your Career Success - http://bit.ly/3XwI55n Natalya Berdikyan: Investing in Yourself to Serve Others on Apple Podcasts -http://bit.ly/3ZMx8yw Questions to Guarantee You Accomplish Your Goals - http://bit.ly/3QASvymSee omnystudio.com/listener for privacy information.

Frank Jaskulke is the VP of Intelligence at Medical Alley, leading the company's startup and global business platforms. He discusses how he got involved ("serendipitously") in the medtech industry, how Minneapolis became known as the United States' "Medical Alley," why he's comfortable with discomfort, and why he advocates that everyone take public speaking classes.  Guest links: www.medicalalley.org Charity supported: ASPCA Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editor: Tim Oliphant Producer: Velentium   SHOW TRANSCRIPT Episode 007 - Frank Jaskulke Lindsey Dinneen: Hi, I'm Lindsey with Velentium and I'm talking with MedTech industry leaders on how they change lives for a better world. Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello and welcome to the Leading Difference Podcast. I'm your host Lindsey, and I am excited to introduce you to my guest today, Frank Jaskulke. Frank is the VP of Intelligence at Medical Alley, a consortium of 800 plus global healthcare companies. He leads the company's startup and global business platforms. Thank you so much for being here today, Frank. Frank Jaskulke: Thank you. It's a pleasure to be on the podcast. Lindsey Dinneen: Oh, I'm so thrilled that you are here. Well, if you are willing, I would love for you to share just a little bit about you and your background. How did you get into this industry? Frank Jaskulke: Yeah. I got into this industry coming up on 18 years ago now, totally serendipitously. Out of college, I was working at our state capital, was just a page, the entry level staff job. And I got assigned to our commerce committee, which at the time was working on legislation to fund joint research between Mayo Clinic and the University of Minnesota on the topic of genomics. I found that interesting, learned a bit more about it. And when session ended, I needed to find another job until the next session, stumbled on Medical Alley. And honest to God, I got a job at Medical Alley the same day as I got a job at Home Depot across the street from our office and Medical Alley had health insurance. So I went with that and here we are, 18 years later. Lindsey Dinneen: Oh my word. Oh my goodness. What a great story. Okay, so very different potential career paths, and you went with Medical Alley. And obviously that turned out to be a great fit for you, but tell me a little bit about growing up. Was MedTech or healthcare something of particular interest? Was it a family interest or sort of what led you to say, yes, this could be the right choice? Even not knowing that you'd be with them 18 years. Frank Jaskulke: Yeah, on the background of it, nothing would suggest this is where I would end up. No family history of it. My mom's a teacher and an artist. My dad's a mechanic. I studied American Indian law in school. Like, that was my focus and that is a family thing. But coming out of the session, landing at Medical Alley, what I learned very quickly was we have this community in Minnesota of healthcare leaders, you know, Mayo, Medtronic, United Health Group, 3M, and so many others, that it's kind of, it's the hometown team. If you are gonna be in healthcare, This is a really good place to do it. And I fell in love over time with all of the innovation and the creativity and most importantly, the commitment that the people had. These are all people who are super smart. They could go do anything, they could go do a lot of other things and make more money, have a less stressful life, but they choose to be in this industry and to do the work, whether it's as a doctor or nurse, or as an engineer, as a business leader. Because they choose that, I just found there was such a deep passion and being around that is motivating and enlivening. Lindsey Dinneen: Yeah, absolutely. And so can you tell me a little bit about your career progression, even through Medical Alley? Where did you start and what are you up to today? Frank Jaskulke: Yeah. I started at the front desk, was the receptionist and staff assistant. At the time, opening the mail, sending faxes. The way we promoted most of our activities was to send the fax to our member companies. It still weirds me out to think when I started, I didn't have a smartphone. I didn't have a computer for work at home, and we were sending faxes and that-- I'm not that old, it wasn't that long ago. But how quickly it changes. But the thing that really kept me was, I got lucky early on and I had a boss, woman by the name of Liz Rammer and a CEO, a guy by the name of Don Gerhardt, who just passed away a couple of months ago, who were totally on board with, bring smart people in and let 'em try things out. So from day one, they were having me meet with the companies. They were having me join in legislative sessions. They got me involved in the different aspects of the business. And when I wanted to try something, they let me try it and if I stumbled, they'd let me stumble and then they'd help me out. And for 18 years now as I've progressed up the organization, that has been a truism of Medical Alley as a company, that we've always had leadership who embraces bringing in smart, creative people with diverse backgrounds and then unleashing 'em and letting them figure things out, being there to help 'em. But you know, saying, if you wanna do it, go for it. Lindsey Dinneen: Wow. That sounds like an absolutely perfect company culture in terms of allowing individuals to grow and be themselves and make mistakes and learn from 'em. I think that's pretty amazing. I can see why you've been there for that long. Frank Jaskulke: It's not that we don't have challenges, but on that one aspect, I think we've done it really well and it's paid off. Former coworkers who are running businesses, have started companies, are executives in other healthcare organizations, have gone into the legislature. We have a state senator that came out of our office. Like great people have come in, done great work and then gone on to bigger things along their journey. Lindsey Dinneen: Wow. Yeah, that is fantastic. Well, I'm curious, is there a particular moment that stands out to you because it clearly confirmed that this was the right career for you, that being in the medtech industry was your path? Frank Jaskulke: I don't know if there was an exact moment, but I do know the string of moments. There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. That simple. That we go and meet with the CEOs of startups, of big companies, of hospitals, of insurance companies, drug companies, and we listen to their problems, and then we come up with creative solutions to resolve those problems as an industry, right? Instead of you having to solve the same problem I had to solve, we solve it once. Once that clicked, it became really easy. I'm gonna hang out with smart people doing great things and my work is gonna make it easier for them to do more great things. Lindsey Dinneen: Yeah, I can understand that. And that brings up an interesting question, presumably-- although you'll have to tell me from your own experience-- but presumably, I would imagine it may have taken a little bit of time to grow into being comfortable in that role. I mean, was this something that you were just naturally extroverted or-- whatever the right word would be-- confident enough to just go into those conversations and, tackle them with ease or is that some element of the job that, you did sort of grow into? Frank Jaskulke: Yeah, definitely grew into. I'm very introverted. Confidence wanes by the day, right? Sometimes good, sometimes not. But I've never been afraid to be wrong. The idea of the more you're wrong, the more likely you are to learn something, I've always embraced. And so I was super comfortable going into meetings and just saying, "I don't know what you're talking about. What does this mean? What's important to you?" And I took advantage of, especially early on in my career-- I was very young, relatively fresh outta school-- a lot of the CEOs were very open to the idea of they wanted to pay it forward, help the next generation, and were willing to just share their knowledge and help me learn more quickly. So the, definitely not confidence, not extraversion, but just purely being interested and being okay with being wrong. Probably longer than most people are comfortable with being wrong. Lindsey Dinneen: I love that. And so can you share a little bit about how Medical Alley does assist its members? I know you have a whole membership platform. I know you do a lot of educational material, you hold events, but I would love to hear from your perspective. Why do people, why do companies want to be a part of Medical Alley and how do you all work together to better the industry? Frank Jaskulke: Yeah. So companies fundamentally get involved for two reasons. One is they care about their ecosystem and community. They wanna make sure that there is this healthcare and health technology industry, particularly in Minnesota, for the next generation. The other reason is they need help for themselves, for their company. They have challenges they're confronting. That they understand can be better resolved together than individually. So the, fundamental operating model of Medical Alley I would describe as, convening to solve common challenges. So back up just a moment. Medical Alley is the only group in the country that has healthcare providers, healthcare payers, and the technology firms, medical device, biopharma, diagnostic and digital health as co-equal partners in the consortium. By doing that, we're able to get these sometimes conflicting groups. I develop a device. I need a payer to pay for it. I need a provider to use it. The payer's trying to manage costs and outcomes. The provider is trying to grow patient volume and deliver better quality. Sometimes those things are aligned, sometimes they're not. We're the only group that can bring that whole ecosystem together and work on getting to better alignment, to ultimately deliver better patient outcomes at lower cost. And what we recognized a long time ago, and this goes back to Earl Bach and one of their founders who was also the founder of Medtronic. He recognized that there were often problems that a company would have that a lot of other companies had as well. And instead of one company solving that problem and then another company having to solve it, and another having to solve it, and a lot of wasted resources that don't help the patient get better. He brought the industry together and said, "Hey, we could identify those problems, distribute our resources and work on them collectively. And we'll more rapidly remove those roadblocks and we'll be able to help more patients as a result." And that is still the rallying cry today. Bring this industry together to solve some of the most challenging problems in healthcare that haven't been solved when we've operated separately, when it's only been hospitals or only medical device, or only the insurance companies. We think if we come together as an industry that's all of healthcare, we can have a bigger impact. Lindsey Dinneen: Yeah, absolutely. Yeah. I know that the organization does a lot of good for a lot of people. So thank you for being here and for being so supportive of the medtech, the healthcare, all of those industries. That is really an amazing thing. So it's cool to hear from an insider perspective too, exactly what you all are passionate about and why you're here. So thank you for sharing that. Frank Jaskulke: Oh yeah. Thank you. Lindsey Dinneen: And then how would you define leadership? Or what does leadership mean to you? Frank Jaskulke: I always feel like that's one of those questions that we all should have an easy path answer, but it's really hard. I think, for me at least, leadership means one working on things that matter. There are lots and lots of things we could do. There aren't as many things that we should do. And so I think leaders are the kind of people, regardless of where they are in an organization, that get us focused on what we should do. I think the second thing is, I would have always the idea of leaders make leaders. That the true sign of a good leader is the people that come out of their mentorship in support and development and become better leaders than you know, the person they were working with. And then maybe the last piece, I think a lot about is, not just being the person willing to make the hard decisions, but being the person who enables your colleagues or your team members to make hard decisions and not worry about it. And I think we've all been in that situation. If something didn't go quite right, then now we gotta tell the boss about it and we're worried about the consequence. I think leadership is creating an environment in which when mistakes happen or when hard decisions have to be made, it's recognized, it's celebrated, it's accepted, not denigrated or punished. Lindsey Dinneen: Yeah, and for folks who might be interested, maybe, especially people that are younger in their careers, what is your best piece of advice for that person who is interested in obtaining a leadership role within the medtech industry? Frank Jaskulke: Ah, learn how to manage sideways and manage up, early. And by that I mean, I see a lot of people who get really hung up on proving their worth and showing like how good they are at a thing or how valuable they are. And you realize, eventually if you get into a management or a leadership role that like the great ones are the ones who help others be better, not who do great work themselves. And so that, early on, learning about how you help others do their work better, how you help elevate your team members and your leaders and your company. I think that's one of the fastest tracks to then become a leader including the promotions and the pay and the title and all of that stuff that goes with it. Because ultimately that's the leader's job. They're not the one necessarily out making the sale or building the project, but they are marshaling the resources and getting the teams motivated to accomplish things they didn't think were possible. That can be done very junior in an organization. You can make others around you better by your presence and by your leadership, regardless of your title or your role in a job. Lindsey Dinneen: Yeah, that's true. I think there's a lot of perhaps, haziness, around the idea of a leader. And I think you're right, it doesn't have to be in your job title or even your job description. You don't have to be, directly managing people underneath you are leading people underneath you. You can be a leader in your own right. And set a good example and make a difference without necessarily having the title to match it yet. There are still many opportunities. Frank Jaskulke: And that's a really good thing you said about setting the example, like modeling the type of culture we wanna have in an organization can be a very powerful part of leadership regardless of your level in an organization. Living the values, making decisions based on those values, and helping others to do the same. But, and I think it's, it sometimes is a big mindset shift for people to make. You know, when you're in an individual contributor role to a great degree, you are measured on what you deliver in the work. Whereas a leader or a manager is measured on what their team delivers or what the organization delivers. And so getting that early mindset of" I'm gonna model those behaviors, I'm gonna help the others around me to be better." I think that's how you get on the rocket ship. Lindsey Dinneen: Yes, and to that point, something that you mentioned earlier, which I really loved was that you essentially, when you were having those initial meetings with CEOs and whatnot early on in your career, and you weren't coming from a place of extroversion or confidence, but you were coming from a place of curiosity and genuine interest and a willingness to learn. And I love that. I think that that's a wonderful trait because it can help you continue to learn and grow your whole life. But I'm curious, how do you prioritize your continued learning and growing as a leader today? Frank Jaskulke: Oh yeah. I don't think it's a matter of prioritization. Learning just has to be all the time. You know, if you're not learning, I don't think you're getting ahead. The world changes far too much. This community and industry is so complex. There's always something new to learn. But then I think even more importantly, it's the mindset of being a learner. You know, if you have a fixed mindset, a mindset of scarcity, you're gonna have a hard time, I think, getting ahead in this world and making a real meaningful impact. Versus a mindset of abundance, of we can make more, and of being open to new ideas and new perspectives, new ways of approaching a problem. So, like for me, learning is my hobby and I don't have other hobbies. I don't play sports. I don't do art. I don't do other stuff. I talk to smart people, ask them questions and learn from them. And I always think of " How to Win Friends and Influence" guide. Lindsey Dinneen: Yes. Dale Carnegie. Frank Jaskulke: Dale Carnegie. Thank you. He had a line in the book where he is " the best way to be interesting is to be interested." Lindsey Dinneen: Yes. Frank Jaskulke: And if I had a life motto, it'd be that. I am just interested in anything and everything, and that has been the difference maker. So it's never a prioritization. It just always is. Lindsey Dinneen: Yeah. So I suppose that in your capacity in getting to continue to interview people because you're also a podcast host. Yeah, I was gonna say, so you get paid to do this, is basically the wonderful aspects of your job. Frank Jaskulke: Bingo. Yep. And that is why I get passionate. I am paid to every day learn something, if not some things new. And by doing that it works out. And I mean, in a lot of ways it's kind of an old sales thing, right? Like people don't like to be sold, but people like to buy stuff. People may not want to hear your story, but people love telling their story. I want people to tell their story, I want to hear their stories, I wanna learn from it. And then that actually makes the business work even better. Lindsey Dinneen: Are there any particular episodes or moments from an episode that really stand out to you in terms of either light bulb moment or a story that just kind transfixed you or something? I'm always curious what about from your perspective, are those moments? Frank Jaskulke: Yeah we've had some fun ones over the years. Recently we had Dr. Bill Maurice, who runs Mayo Clinic Laboratories, and during the pandemic became very prominent because he's a massive, massive sports guy. And he started going on some of sports radio shows to talk about Covid and talk about vaccination. And this is an MD PhD, incredibly smart person, but who also is really into hockey and basketball and football and everything. He was able to connect with a group of people who were not as receptive to the traditional way of communicating about public health and vaccination. And have honest, thoughtful, open conversations about what was going on. And I would argue I probably made as big of a public health impact as anyone as a result. And it, it just really struck me how humble and honest and authentic he was about it. You know, It wasn't an air for him, it was legitimately him and he was excited to be on ESPN sports radio programs, like he was nerding out about it and able to then make a public health impact. So that has stuck with me. The other one I've always liked, and I've interviewed her a couple of times, Lee Jones, who is the co-founder of a company called Rebiotix, and a longtime Medical Alley board member. She was a Medtronic executive in the medical device industry and started a biotech company in a state that is not known for biotech. But what's crazy, when they started the company, she thought she was starting a medical device company, and so it set it up as a medical device company, did all the normal stuff, and then the FDA said, "actually, you're a drug." And they had to pivot on the fly from a device company to a drug company. And the way she handled that pivot, the people she got involved, she was doing remote and hybrid work back in 2015 with this well before it was much of a trend. That company got FDA approval in September last year. They had a nice exit, great return for the investors, and hearing her story of a successful entrepreneur, a corporate executive, and pivoting from med device to drug and just going with it, I have found very inspiring. Lindsey Dinneen: Yeah, that is amazing. Wow. Well, on a bit of a less serious note, so I've always wondered this, why Minnesota, why is Minnesota Medical Alley, just out of curiosity. I think Minneapolis is a cool city, but I'm just curious, what is the attraction? How did that become what it is?. Frank Jaskulke: The honest to God, glib answer, but it's correct, is two things: the Mayo brothers stopped in Rochester 150 years ago, and Earl Bachan was born in Northeast Minneapolis. That was it. Like it wasn't planned. It wasn't a grand design, it was, Earl Bachan born here, started the modern medical device industry, Mayo brothers here, start the modern healthcare system and then we doubled down on it. The industry existed. And then we had thoughtful leadership, Earl Bachan, the Mayo Clinic leadership, a guy named Lee Berlin who came out of 3M, and at the time, Governor Rudy Perpich, back in 1984, they got together and they said, "Hey, we have something here we should build on it." So they created Medical Alley, the company, to organize and promote the industry. So we got lucky. And then if anyone out there, if you've read "Good to Great," we capitalized on our luck, right? We maximized our return on luck by doubling down on the industry, building it up, and creating an environment where if you're here, if you're doing medical device, you're gonna find the workforce, you're gonna find the suppliers, you're gonna find the investors, and you're gonna find the companies that might buy your company. If you're in digital health, you're gonna find the same thing. And increasingly, that's even becoming true if you're doing a biopharma startup here. Over time, a complete ecosystem is built up. But as Warren Buffet used to say, "we hit the genetic lottery" in having Earl Bachan born here and having the Mayo brothers stop here. Lindsey Dinneen: Very nice. Okay. There we go. Now I know. Well, speaking of not quite as serious questions, but imagine someone were to offer you a million dollars to teach a masterclass on anything you want-- does not have to be in your industry-- absolutely anything. What would you choose to teach and why? Frank Jaskulke: Oh, that, that's easy. I would teach a class on the fundamentals of public speaking. Yeah. It's a skill that, no matter what you do, whether it's big business, a nonprofit, government, anywhere, public speaking, communication is so fundamental and a lot of people are scared by it. And then there's a lot of people who aren't scared by it, but do it poorly. And, harm their ability to drive their cause forward. So yeah, I'd do that one for free, but I'd certainly do it for a million dollars. Lindsey Dinneen: Amazing. Well, okay, so that does generate a follow-up question then. Did you take extensive public training courses or classes or Toastmasters or anything like that? Or is your own experience over the years led you to a place where you would be confident in teaching a class. Frank Jaskulke: Yeah. In high school I got very lucky and was recruited onto the debate team, had no idea what it would be about, fell in love with it and then joined the speech team and that has been more useful and a bigger contributor to my success professionally and personally than my undergraduate degree, than my graduate degree, than anything I've done. High school speech and debate is the best thing I've done in my education. Lindsey Dinneen: Agreed. Yeah. I will second that. I actually also did speech and debate in high school . Yeah. And I do agree it is one of those, or two, of those classes or activities that you can do that actually do carry over substantially throughout your life, so. Frank Jaskulke: Anyone out there if you've got kids that are thinking about stuff, it is well worth encouraging your kids to check it out. It is such a force multiplier. Lindsey Dinneen: Yes. Agreed. What is the one thing you wish to be remembered for after you leave this world? Frank Jaskulke: I don't really care if I'm remembered or not. It kind of gets to the why, like the only thing I'm really interested in is that the impact happens. Whether or not people know I had a part in it, I'm okay with, I'll know. Lindsey Dinneen: Yeah. Okay. And then final question. What's one thing that makes you smile every time you see or think about it? . Frank Jaskulke: Oh, that's easy. That'd be my cats. We've got two cats, Astra and Zeneca. They're getting up there in age, but they're still, get home. They come and welcome me. Sleep on the bed all night. If days are warm or cold, they're always there. The cats. Lindsey Dinneen: Aw. Well that's amazing. And it sounds like they're actually rather social for cats cause I think sometimes that's at risk. Frank Jaskulke: Yeah. They're a little bit dog-like in how like clingy they can be. Um, not the aloof cats that we normally would think. Lindsey Dinneen: Oh my gosh. Now, did you grow up with cats or was that something that you had, as an adult or where'd your love of cats come from? Frank Jaskulke: I've always had pets. Yeah. We always had at least two cats and at least one dog forever. Lindsey Dinneen: That's wonderful. Well, Frank, I just wanna say, this was so much fun to hear about you and your background, why you're passionate about the industry, what Medical Alley has done, not only for you personally, which is wonderful, but obviously for the world, how it's impacting lives. So I just wanna say thank you for sharing all of those stories and the behind the scenes. I love hearing that. And we are honored to be making a donation on your behalf as a thank you for your time today to the American Society for the Prevention of Cruelty to Animals, which is dedicated to preventing animal cruelty in the United States. We really appreciate, Frank, you choosing that organization to support and thank you just again, so very much for your time here today. It was so much fun to talk to you and get the behind the scenes, and I just wish you continued success as you work to change lives for a better world. Frank Jaskulke: Thank you. I really appreciate you having me on and letting me share a bit about what we're up to, and I appreciate that Velentium is collecting these good stories to share more broadly, and has been a part of the Medical Alley community. And to everyone out there, thank you for listening to this story and helping to spread it. Medical Alley is always here at your service. Lindsey Dinneen: Yes. Thank you again, Frank, and thank you also to our listeners for tuning in, and if you're feeling as inspired as I am right now, I'd love it if you share this episode with a colleague or two, and we will catch you next time.  The Leading Difference podcast is brought to you by Velentium. Velentium is a contract design and manufacturing firm specializing in the development, production and post-market support of diagnostic and therapeutic active medical devices, including implantables and wearables for neuromodulation and other class three indications. Velentium's core competencies include electrical design, mechanical design, embedded software, mobile apps, contract manufacturing, embedded cybersecurity, OT cybersecurity, systems engineering, human factors and usability, and automated test systems. Velentium works with clients worldwide from startups seeking seed funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

The "Consolidated Appropriations Act of 2023" (more commonly referred to as the Omnibus Act) was passed and signed into law on December 29th, 2022. This amendment to the Food and Drug Cosmetic Act has expanded the scope of the FDA beyond just "safety and efficacy" to include the cybersecurity of medical devices. This amendment resembles a watered-down version of the PATCH Act, which failed to pass in late 2022.As a result, on March 29, 2023, the FDA gained the legal authority to define and enforce medical device cybersecurity. So for today's episode, we got THE leading minds in MedTech cybersecurity together to discuss what we need to do next. Chris Gates, Director of Product Security at Velentium, Chris Reed, Vice President of Product Security at Medtronic, and Ken Hoyme, CEO of Dark Star Consulting, join the podcast today to discuss the new guidelines, what the FDA can and can't say about it, and what kinds of deficiencies you'll be seeing in the future because of the new legislation.Some of the highlights of this episode include:How the FDA tried to clear a path for routine patches and updatesThe minimum that the omnibus bill is talking aboutNo longer needing to make the link between cybersecurity and safety and effectivenessWhen they have the legal authority to enforce cybersecurityWhy the document took so long to go throughSecurity architecture analysisWhy you should be referencing the April 2022 draftUnpatched vulnerabilities at the time of submissionThe effort needed to understand the FDA's intentionsMemorable quotes from this episode:“Literally, if you're not aware of this already, you're already behind the 8-ball right now and there's things you've got to do.”“Basically, if you think it might be a cyber device, it is a cyber device.”“Don't sit there and try to be pedantic about this and say “I don't need to do this because there's a comma here.” It ain't gonna work for you.”“A synonym for threat modeling really is security architecture analysis.”Links:Christopher GatesChris ReedKen HoymeVelentiumMedtronicDarkStar ConsultingMedical Device Cybersecurity in 2023 and Beyond SlidesEtienne Nichols LinkedInGreenlight Guru

Shannon Clark is the founder and principal of UserWise, a consultancy that helps medical device manufacturers and startups to design safe and easy-to-use medical devices. In this episode, Shannon discusses her experience founding her company, the importance of human factors engineering, her love of history, and why she's so happy about her recent "demotion." Guest link: www.UserWiseConsulting.com Charity supported: Equal Justice Initiative Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editor: Tim Oliphant Producer: Velentium   SHOW TRANSCRIPT Episode 006 - Shannon Clark Lindsey Dinneen: Hi, I'm Lindsey with Velentium and I'm talking with MedTech industry leaders on how they change lives for a better world. Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello and welcome to the Leading Difference Podcast. I'm your host Lindsay, and I am excited to introduce you to my guest today, Shannon Clark. Shannon is founder and principal of UserWise, a consultancy that helps medical device manufacturers and startups to design safe and easy to use medical devices. Before founding UserWise in 2014, Shannon was a human factors engineer at Intuitive Surgical and Abbott Laboratories. Shannon graduated from UCLA with a BS in Mechanical Engineering and a technical breadth in technology management. Shannon is additionally a certified professional industrial engineer, holds two patents and has written and published three books. Clearly an absolute rockstar, thank you so much for being here, Shannon. Shannon Clark: Yeah, thanks for having me. Lindsey Dinneen: Of course. Well, I would love, if you don't mind just sharing a little bit about your background and maybe how you got to where you are. I know, you've gotten to do some really amazing things. You have an amazing company. I would just love to hear a little bit of that backstory. Shannon Clark: How far back should we go? I think it's interesting that on my application to USC, I ended up going to UCLA, but I did apply and get into USC, just for the record, and on my application. I said that my dream job, I was 17 years old, would be to run a product design firm in Spain. It's pretty interesting that I kind of ended up there and I kind of had that idea so early on, but I didn't really fall in love with human factors or even know about it until I was working at Abbott Laboratories and I had this unique opportunity to apprentice one of the world's leading experts in human factors named Ed Israelski. He was the Director of Human Factors for Abbott for many years, and laid all the groundwork for the international standards and it informed the FDA guidances around human factors, so it was a really unique opportunity to work for him. And from there I was able to really dive into human factors with that practical experience at Abbott. And I knew that I wanted to run my own company basically. And I think I, I finally made it there in 2014 when I saw some great opportunities to help fledgling companies out of Stanford Biodesign and Fogerty Institute for Innovation. And I started out with just myself consulting, and then from there built a practice and pretty soon it was 30 human factors engineers, recruiters, and operational staff as of 2022. Lindsey Dinneen: Wow. That is amazing. Congratulations. That's, that is no small accomplishment. That is amazing. So human factors engineering specifically wasn't necessarily, it sounds like, the first intention that you may have had going into school. So it's awesome to hear that having that experience is what sort of led you into your career path, but I'm kind of curious, were you always very technically minded, kind of interested in user experience growing up or what was, even going back a little further, what was the spark that interested you in that field in general? Shannon Clark: Well, I had actually never heard of engineering. My mom's a lawyer, my dad's an accountant. So I didn't know what engineering was going into college, and so I was gonna, study Latin or Spanish or something. But then I thought I don't really know what I'm gonna do after college if I study that. And I had an uncle who was an engineer who said, "you really should check this out." So I took some coursework and I thought I could probably do this. And to be honest, mechanical engineering was a big struggle for me, having not taken any of the AP courses. I took AP Latin, AP Music Theory, all the APs that you don't need for engineering. So I came into school pretty behind and feeling behind, but I made it through and I kind of had my eye on this goal of making user experiences easier for people. I was going back even further, I was really inspired by my uncle Peter Skillman, who's now with Phillips I think in their Design Center of Excellence. And he worked at IDO at the time and he was 35 years old and contributed to this project that was featured on 60 Minutes to redesign a shopping cart. And it was really inspiring to me at the age of 10 or seven or however old I was, to watch someone take something so mundane as a shopping cart and uncover all these issues that exist with shopping carts everywhere, and then completely rethink the design and improve it. And rewatching that video I can now kind of see with another lens that they even started on the basis of safety and designed for safety, which I believe is so important when prioritizing design efforts to think about, " well, how many injuries are there to toddlers every year in shopping carts and how can we address this and how can we make it better?" And then just a month ago, I actually had my toddler in a shopping cart and she got stuck because the seatbelt wouldn't unlatch. And then it made me think that's interesting, full circle. Lindsey Dinneen: Oh, that is interesting. Oh, the irony. Oh my gosh. Okay. Yeah. So designing for safety first. So I'd love to hear the evolution of you just starting this consultancy by yourself. And I mean, so you were literally doing all the things, you were marketing, you were doing the actual consulting, you were doing the accounting, I'm assuming. How did that all evolve and how did your leadership ability evolve as you've grown your business? Shannon Clark: Well, I started out with no management experience, quite young. I started out with just myself. I hired some contractors here and there in 2015 . 2016, hired my first employee and I gotta tell you, I was the worst manager. And she was like, patient zero, she's now at Intuitive Surgical. But I think overall it was a great step in her career, but good for her for getting through, I think, four years of reporting to me as I was learning to be a manager. And I think over time through trial and error, I became a better manager. That was sort of a learning experience for me. And something that people were always telling me as I was starting my company was, " you should learn on someone else's dime. Don't start a company and then learn these hard lessons on your own dime." But I'm happy that I didn't listen to them and sure there were a lot of really expensive life lessons, like the time we didn't expense $150,000 of expenses because I didn't realize that someone wasn't doing their job for four months. There's all kinds of things that happen as you're start a company. But you just have to learn from them and then embed processes to address any gaps that you uncover along the way. And so at this point, we're just such a strong company with so many internal processes and trainings and rigor, and it's really exciting to see how much it's matured over the past eight years. Lindsey Dinneen: Yeah, absolutely. Well, and correct me if I'm wrong, but it seems like you recently, in fact, had a bit of a transition even for yourself, for your role. Is that correct? Shannon Clark: Yes, we brought in a new CEO. I was able to secure significant private equity investment from a private equity firm called NaviMed. And so we're forming a new umbrella organization called ClariMed. And so that's sort of a broader quality by design thesis where we're bringing together a bunch of like-minded organizations to help support product development, specifically in the medical space. And we're starting that organization with two human factors consultancies. So it started with UserWise, my company, which was acquired in August of 2022. And then in January this year, 2023, we acquired Harvey Medical, which is a seven or eight person human factors consultancy in the UK and the Netherlands. So, that's where we're at today and I'm thrilled. I, I probably put on LinkedIn that I'm thrilled about this quote- unquote "demotion" to Principal Human Factors Engineer, 'cause previously I was Director of Human Resources, CFO, CEO, and Principal Human Factors Engineer, and it was a lot. Yeah. Let's just say I didn't get a maternity leave. But now I'm just really excited for the future and I have a CEO with 17 years experience running and growing a regulatory consultancy. So I, I'm just really excited to report to her and she's an inspiration to me every day, Kelly Kendall. Lindsey Dinneen: Awesome. That's fantastic. How has the transition been for you? Did it take a lot of transition or did it come easily? How was it for you? Shannon Clark: It's been a huge transition, cuz Kelly runs the business based on data and I think when you have investors involved, you have to really present a lot of data to them. Whereas before I didn't have to report to anyone or speak to anyone or ask anyone any questions about what I'm doing, which I think we're a lot better off now cause I'm not just making decisions as I go along. I have a, a whole support system to help me through all the decisions on a day-to-day basis. So, that's been really relaxing to share the responsibility and, and have support. But yeah, it's been a lot of work to try to come up with the data. We're trying to integrate Salesforce. We're just kind of like a small company, quickly growing, so there's a lot there to work on. Lindsey Dinneen: Yeah. Absolutely. I'm curious, is there a particular moment that stands out to you because it kind of clearly confirmed that this was the right career path for you or the correct industry? Shannon Clark: It just immediately clicked. Back when I was working for Ed Israelski at Abbott and contributing to standards committees and submitting feedback to the FDA and draft guidances on behalf of Abbott, all of that work really created a spark within me, I'd say. And I think I would pinpoint it on one project I worked on, which was to review all recalls of medical devices by the FDA over the course of time that were due to human error. So, for example, an automated external defibrillator that was on the market, I think this was 2009, where there was a low battery indicator that would blink and falsely cause individuals to cease use of the device unnecessarily. So the idea that they were confusing this red indicator light to mean, "oh, this is broken, don't use it," versus "it's just low battery. Change the battery when you have a chance, but you could have resuscitated the patient." And I wrote this 80 page internal report. All these events that had happened and it really brought to life the importance of the then new FDA focus on human factors. And the fact that you need to really intentionally bake safety into the design of products from the get-go. It's not something you can just add on post-market or even figure out through human factors validation at the end of the process. It's something that you need to think about constantly throughout design, and again, prioritize those design efforts according to risk and safety and according to patient harm and user harm so that you can, at the end, have a product that doesn't result in a recall like that. So when I saw all that data, it really centered my focus and brought clarity to me that this is something that I wanna do for the rest of my life, 10 years, 20 years. I don't know. I guess I wouldn't say for the rest of my life. But I really was super inspired to do something about it cuz I also read that there were half a million deaths every year due to preventable medical errors in hospitals alone, just in the United States. So we basically have a whole pandemic happening every year in hospitals. And some of that is due to medication errors and hospital processes. But that figure doesn't even capture instances where they amputated the wrong leg. I mean, these are deaths. And so I'm, I'm really dedicating my career to reducing that number of half a million to something lower. Lindsey Dinneen: Wow. Yeah. That's amazing. I'm so thankful for people like you that are doing that research and like you said, safety first, building it into the design from the very get-go. That's fantastic. Yeah. Shannon Clark: And I love what Velentium's doing with regards to cybersecurity. I think that definitely follows the same kind of premise of protecting users and ensuring safety. Lindsey Dinneen: Yeah, absolutely. Yeah. There is so much that goes into it. So any angles that we can take to help protect people is absolutely worth it. So, how would you define leadership or what does leadership mean to you? Shannon Clark: I think leadership to me is inspiring others to be their best selves and fulfill their own missions, whatever it may be. So sometimes I can spark someone to be inspired to follow my footsteps and become a human factors engineer. Or maybe someone wants to pursue something a little bit different and just letting them uncover their own truths and pursue their dreams. That's probably the main thing I ask in interviews, " what is your dream job?" Because I wanna make sure that you're in your dream job, whatever that may be. So I guess that's what leadership means to me. Lindsey Dinneen: I love that. Yeah, absolutely. And then what would be your best piece of advice for someone interested in obtaining a leadership role, either within the medtech industry, or very specifically following a similar career path to what you've done? What would you say to someone who that's a goal of theirs? Shannon Clark: Well, my specific path, I believe, can in fact be replicated, in that, I saw an opportunity to uniquely become an expert in a field that was emergent. And there's many emerging fields that result from regulatory shifts. And in this case, UserWise, came out of the 2011 draft guidance about human factors issued by the Food and Drug Administration that was later published as final in 2016. And so there from my position at Abbott in 2010, 2011, I was able to see that coming down the pike and I saw the huge amount of opportunity at hand, and I saw where industry was and where it would be going. And out of that, I was able to found my consultancy. So I worked tirelessly to transform myself into an expert, not only by working 12 hour days at Abbott and giving them everything I had, but also reading all the textbooks on the syllabus for human factors master's degrees at various universities and had a stack of 20 books that I was working through. So it was all sort of self-taught, but ultimately I saw this opportunity due to a shifting regulatory landscape and things like that happen all the time in all industries. And there's all these opportunities that exist that are just a great opportunity to create a new business around it whether it's consulting or software as a service. Yeah, tons of opportunities out there. Lindsey Dinneen: So sort of being open to maybe opportunities that you wouldn't have originally pinpointed for yourself, but being aware of various trends and kind of responding to the situation. Is that part of it? Shannon Clark: Yeah. I mean, ultimately, I guess I'd describe my business model, if it were to be replicated, if you wanted to have success in this manner is to uncover regulatory trends and then find an opportunity, a business opportunity within that. But I guess more generally, if you're looking for a leadership position in the medtech field, I think that expertise certainly is highly valued. And engineering abilities is also highly valued. So, I think you need to go deep before you go broad. I think I do see a lot of like marketing experts, that maybe haven't gone scientifically deep, end up as CEOs of these companies, but I think the best background of all the CEOs that I work with, I always enjoy working with CEOs that have a technical background cuz they can truly understand the ins and outs. And I, I see limitations among some of these CEOs that maybe just have sales backgrounds. Lindsey Dinneen: Sure. Yeah, that, that makes a lot of sense to me. I can understand that. Shannon Clark: I think I'm talking to a salesperson right now, so I hope I haven't offended you. Lindsey Dinneen: Not at all. I am more on the marketing engagement side of things, but I wouldn't be offended regardless, because you're right, you need both to be successful. So, absolutely. Shannon Clark: Go deep first and then go broad. That's kind of the advice that was given to me as well and I followed that advice. Lindsey Dinneen: I like it. I like that a lot. Yeah. Well, so I know from your bio that you are a published author three times. Right? I would love to hear about that and what have you written about and how did that all come about? Shannon Clark: Well, nothing too impressive, and it's quite off topic, but I really enjoy history. So I authored a history of a local neighborhood, which is actually where UserWise is located in San Jose. And so I wrote this 150 page history book and we sold I think 3000 copies. And all the funding went to fund local farmer's markets as well as ultimately the annual 4th of July parade for San Jose. So I wrote that book and then wrote a follow on, a sequel about parades in the Bay Area, California. Have you ever heard of the Pasadena Tournament of Roses? Lindsey Dinneen: I have. Shannon Clark: So, we used to have one of those in Northern California. There's a whole Northern California, Southern California rivalry. That was huge when I went to UCLA. But we used to have our parade and our parade died out with the Great Depression, and we tried to resurrect it in 1960, but it didn't work out. So it was just kind of an interesting forgotten history that I wanted to capture in a book before it got lost forever. Lindsey Dinneen: Yeah. That is awesome. Very cool. Shannon Clark: And then the third book is how to get a job in management consulting. It's called "College2Consulting." It's a silly book, but I think it's pretty helpful if you wanna get a job at LEK or some management consultancy. I didn't come up with all the material for that, but I was the ghost writer. Lindsey Dinneen: Oh, so cool. That's awesome. So what are some interesting industry trends that you are looking forward to as you continue on with UserWise and beyond? Shannon Clark: I guess when I think of industry trends, I immediately think of what's happening with Europe, with MDR, and where's the FDA headed specifically with regards to human factors cuz that's ultimately what's gonna guide where UserWise is going next. With the FDA, there's been a lot of turnover with their human factors review team over the past five years, and it's created a shift towards requiring more and more. I think that's always the story with regulations where before maybe we didn't submit a full 60 page human factors engineering submission report for a lower risk device and just submit a protocol. These days they're just rejecting a protocol if there's no full backup for all the elements found in a human factors engineering submission report. So I think overall, I guess as always there's just more and more regulations. I do hope to make some progress. I'm headed to the International Standards Committee later this month in Germany, and I hope that I can kind of start socializing some ideas around reducing the burden from an international standards standpoint for human factors. So, I guess another industry trend that's a little more specific is that we just finished our multi-year study on training decay, whereas in collaboration with the Food and Drug Administration. And to date for combination products, so drug delivery devices, you're basically required to conduct human factors testing with untrained users. And it's created a context where there's some drug delivery devices where if they were pure medical devices, they would easily get clearance. But since they're a combination product, they have a drug, they're reviewed by DMEPA, CDER, a different human factors team. They're just unapprovable because untrained users are not capable of using them successfully. So I'm hopeful that with our research, we can further promote the concept of trained usability testing and invite more devices to the table instead of requiring perfect use for combination products. That's a hope of mine. But again, with more and more regulations we'll see if that comes to fruition. Lindsey Dinneen: Yeah, of course. Yeah, that sounds like a really good path forward. So it'll be interesting to see, like you said, how the landscape changes over time. So how do you prioritize your own continued learning and growing as a leader these days? I know you mentioned having stacks of textbooks, which I love, but nowadays, how do you continue to develop your own skills and knowledge? Shannon Clark: Well, I think I mentioned earlier that I am thrilled to report to Kelly Kendall, CEO of our company. And so I learned from her every week by watching the way she runs the company, the way she makes decisions. I've just learned a ton. It's been drinking through a fire hose with regards to key performance indicators and everything to do with running a business in a more formal manner. Cuz I ran my business based purely on intuition and not really on data. And when you really get a grasp of all the data associated with a business, like she says, it's about turning knobs up and down and adjusting and fine tuning once you know what the knobs are. And so, I feel like myself professionally, I've grown so much just having a mentor continuously working with me. I have in the past had executive coaching, but that, that, pales in comparison to what I'm now able to experience having a seasoned and experienced CEO to report to. Lindsey Dinneen: Yeah, and it's completely a hundred percent relevant to you and your business, which is awesome that you get that experience. Very cool. Okay, so just for fun, imagine that someone were to offer you a million dollars to teach a masterclass on anything you want, doesn't have to be in your industry. What would you choose to teach and why? Shannon Clark: Well, I think the answer that I might be supposed to say is moderating. So I have a lot of experience moderating usability testing and minimizing bias for participants so that you can extract truth. So basically, as a moderator, you don't wanna get in the way of the truth of what a participant is experiencing or feeling or demonstrating through their interaction with a product. So we just launched a moderator course, which I'm really excited about. But I guess after having done all that work for the past months to launch that course, I need a break. So if I could teach a masterclass, I guess it would be on the history of the Maya, which right now I'm trying to learn Mayan hieroglyphs. And I have an interest in archeology. And to be honest, I know nothing about the Maya, but maybe I have a kind of a crazy overconfidence going on where I feel that I wanna learn everything about it. And I, I feel like I've done this in a couple of areas of my life where I'll learn everything about a subject and then kind of become like an expert. And so that's kinda my next side hobby. I have some ideas there about what I'm gonna do. Lindsey Dinneen: Oh, that's awesome. So what sparked your interest specifically in that? Shannon Clark: I think in part it's because I've been to Mexico a number of times. I speak Spanish. And then I have an aunt who's Mayan who was involved in kind of raising me at an early age. So, that definitely sparked my interest. And then I've been honestly, like watching a lot of TV about Ancient Apocalypse and all those shows. I don't know if you've seen them, but I was just like, oh yeah, this is so cool. Lindsey Dinneen: I love it. Yes. Isn't it great to have something outside of your main, day-to-day job life focus that just kind of brings you this other level of passion and joy-- I'll just put it, put it that way. Shannon Clark: Yeah. This is certainly, it really stems out of being able to share the burden of running a company with others namely my boss Kelly, and it opens up my time to actually think about other things. And that has been a focus for me since the transaction in August. It's something I'm excited about just to have some extra hours in my week to think about things that aren't related to work. Lindsey Dinneen: Yeah. That's fantastic. So what is the one thing you wish to be remembered for after you leave this world? Shannon Clark: I guess being a good mom and that's really all I care about. I have one daughter, her name is Emily, and she is 22 months old. And she's great. So that's definitely my focus to be a great mom. And it'd be cool to be remembered as a good contributor to the industry of human factors, but I think more importantly, I wanna be a good mom. Lindsey Dinneen: Yeah. Yeah. Absolutely. Aww. Oh my gosh. I love it. What is one thing that makes you smile every time you see or think about it? Shannon Clark: Well, my daughter Emily, obviously, lemme try to come up with a different answer. Lindsey Dinneen: Ok, it's a great answer though. Shannon Clark: Yeah, that's gotta be my answer, sorry. Lindsey Dinneen: No, that's fantastic. Well, I just want to say thank you so much for sharing a little bit about your background, about your company, about the industry, where you think things are going, and your advice. I just really appreciate your time today, and I love hearing the why behind how you got into this and what makes you tick. So, thank you. And plus, it's really fun to hear about your hobbies outside of work too. And Emily, and course Emily. So, we are honored to be making a donation on your behalf as a thank you for your time today to the Equal Justice Initiative, which provides legal representation to prisoners who may have been wrongly convicted of crimes, poor prisoners without effective representation, and others who may have been denied a fair trial. So Shannon, thank you so much for picking that organization to support today. Thank you so much for your time. We wish you continued success as you work to change lives for a better world. Shannon Clark: Thanks so much. Thanks for having me. Lindsey Dinneen: Of course. And thank you also to our listeners for tuning in and if you're feeling as inspired as I am right now, I'd love if you'd share this episode with a colleague or two, and we will catch you next time.  The Leading Difference podcast is brought to you by Velentium. Velentium is a contract design and manufacturing firm specializing in the development, production and post-market support of diagnostic and therapeutic active medical devices, including implantables and wearables for neuromodulation and other class three indications. Velentium's core competencies include electrical design, mechanical design, embedded software, mobile apps, contract manufacturing, embedded cybersecurity, OT cybersecurity, systems engineering, human factors and usability, and automated test systems. Velentium works with clients worldwide from startups seeking seed funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Duane Mancini is the CEO managing partner and founder of Project Medtech. In this episode, he shares how Project Medtech quickly evolved from one industry podcast to two, then to consulting for medtech startups, and now to hosting events. He also discusses his passion for the industry, his background as a scientist, and how his family, friends, and the startups he helps motivate him and always prompt him to smile.  Guest links: https://www.projectmedtech.com/ | https://www.linkedin.com/in/duanemancini/ Charity supported: Save the Children Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editor: Tim Oliphant Producer: Velentium   SHOW TRANSCRIPT Episode 005 - Duane Mancini Lindsey Dinneen: Hi, I'm Lindsey with Velentium and I'm talking with MedTech industry leaders on how they change lives for a better world. Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.  Hello and welcome to the Leading Difference Podcast. I'm your host Lindsey, and I am very excited to introduce you to my guest today, Duane Mancini. Duane is the CEO managing partner and founder of Project Medtech. He has extensive experience in go-to market strategy, including regulatory and reimbursement, biocompatibility, preclinical efficacy testing, and clinical trial design and execution. As a result of his unique background, he has developed a comprehensive understanding of what early stage startups need to do in order to be successful. And I am just so thrilled that you are here today. Thank you so much for joining us. Duane Mancini: Yeah, thanks. Thanks for having me, Lindsey. This is super exciting. Congratulations on launching the podcast as well. I know the work that is required to do that. Lindsey Dinneen: Yes. And in fact, that is where I would love to just dive in because you have such a cool story about the way that Project Medtech has come about and I would just love to hear it, if you don't mind sharing it. Duane Mancini: Yeah, for sure. So you know, my background as a chemist, I got my start at a company called NAMSA, and NAMSA is just a CRO in the medical device space, but phenomenal company when I was there that invested in their employees and so they allowed me to learn a lot of different aspects what a medtech company needs to do to bring a product to market, which was super nice. I had left there, though, in April of 2020 and went to a company called Covance, which was then acquired by LabCorp, and I think now just recently spun off again. But in between me leaving there, I wanted to continue to give back to startups and learn the way I learned, which was talking to people, experiences, that sort of thing. And I had found podcasts really interesting and there was no one really out there doing a podcast on what it took to run a medtech company. So I said, "well, I'm gonna do this." It'll keep me close to the startup scene where all the innovation is happening. I'm gonna do this podcast. So I worked with one of my buddies from high school to do the design of the Project Medtech logo. And I worked with another friend who was up in Chicago to do the jingle. And that's where I started, April 2020 right in the middle of everything shutting down cuz of the Covid pandemic. Yeah. So, launched the podcast and there was always this greater idea of what I really wanted to do, which was launch a organization around really specific vertical of medtech startups. And the podcast was just the first idea of it. And so yeah that's really where it started. Lindsey Dinneen: That's a fantastic start. And I do want to hear the details too, because, relatively speaking-- although I'm sure there were times that did not feel like this to you-- but from an outsider's perspective, I look and go, wow, a lot has happened really quickly for your organization. So I would just love to hear more about how it's evolved. Duane Mancini: Yeah. And I'm happy to share and I'm an oversharer, so I'm gonna share some of the personal details as well and hoping that it inspires other entrepreneurs and people with ideas and whatnot, cuz that's really important as well. So I start the podcast and like I said the pandemic kind of shuts everything down so people stop going to events. And so I stay really consistent on it. That was the whole idea. It was weekly podcast, no matter what, get it out. And so I started doing that. And about six months in, I had some people reach out and say, "Hey, how do I sponsor the podcast?" And I said, "interesting idea. I don't know." So I took that back, reflected on it and said, "well, it makes sense, right?" We're getting way more listens than a webinar would get, and it's weekly, so it's amplified even more than that. And so I gave it some thought. I worked out an agreement with the first person to come in and sponsor. And then that's when I said, "Hey, you know what? I maybe need to think about the other ideas I had for the rest of the company." And so that's when I approached a co-founder named Aaron TenHuisen, who was a guy I knew from a doubles volleyball league I played in and just someone I had conversations with. So I approached him, told him the ideas, and he joined in November of 2020 to help with some of these ideas and I guess the concepts of what I wanted Project Medtech to be. So I worked with him to work out some of those kinks, sell him on the idea, and really kinda what we settled on was, "Hey, let's keep going after this media piece of this podcast and continuing to grow this brand." And so in the same year my wife gave birth to our first daughter in December of 2020. And so, it was just crazy with personal life, working a full-time job and then trying to get this podcast that was gonna be the launching pad for our larger company off the ground. Lindsey Dinneen: So then you're a new dad? Duane Mancini: Yeah. Yep. Yep. Lindsey Dinneen: And you've partnered up with Aaron and then and then what? Duane Mancini: Yeah. So, so that continues to go really well. The podcast continues to expand. That is when I had reached out to another person in my network, Rich Mazzola. I knew his sister back in college. She was friends with my wife, and we had just been in the same area. He was doing fractional CFO support for medtech companies, oddly enough. And so I reached out to him and said, "Hey, this is our idea, we have our media company that we're gonna do this podcast and do some events within, then I have this idea for this consulting advisory group." But I have my background from NAMSA and LabCorp, but I'd love to get how CPA firms run their practices and law firms, right? Maybe there's some mix of how we need to be doing this. And so I of talked to him and sold him on the idea of, "Hey, why don't you come in and just be a co-founder here with us and help us conceptualize the idea?" And so, he was the next co-founder to, to really come in and be a part of helping me conceptualize how we would eventually launch this consulting advisory service. So, I'll leave that one there, but he comes on in May of 2021. I gotta back up real quick, and this is part of that personal journey. So, in March of 2021, my wife comes off of maternity leave. She's a physical therapist and gets laid off. And so, besides what everyone's probably thinking of, "there's a lot that's probably illegal," was. So all of 2021, I'm reaching out to Rich, and when I reach out to Rich, I'm having these personal discussions with my wife of, "okay, well, she just got laid off. Does she go back to work full-time? What does that look like?" And oh, by the way, Project Medtech going towards this path of I'm gonna have to make a decision to either step back from my LabCorp position and do this full-time, or Project Medtech stays at just a podcast. And so we're having those personal discussions as well of, "okay, we have the comfort of a nice job at LabCorp, but this is what I really want to do." So all of this is of going on for me personally as well, beyond just the Project Medtech evolution, which is super exciting, but also super scary. So there's this. Lindsey Dinneen: Oh my gosh, yes. Duane Mancini: Yeah. So, we progress further in that year, and by June, it's almost apparent that starting in 2022, I'm going to have to quit my job at LabCorp and go in to Project Medtech full-time if we really want to make a go at this, based on the positive momentum we're having. But also within June, I reach out to Giovanni Lauricella, who's part of Lifeblood Capital now, and approach him and say, "look, I'm getting a ton of people reaching out about raising and investing capital in medtech. You have this a presence on LinkedIn, as well, about raising and investing capital. Why don't you come do the podcast called Medtech Money for us at Project Medtech and host it. I don't have time to host another episode or another podcast series, but I do have time to produce it. So, would you be interested in that?" And he's, "oh my gosh, a hundred percent, let's do it." And so, Giovanni comes on board and hosts the Medtech Money podcast series powered by Project Medtech and centers it around investing and raising capital specific to medtech. And so, it's been an absolutely wonderful partnership. He has Lifeblood Capital now, which is a recruiting firm and does this for us, and we both share in the benefit of putting out this podcast and giving back to the community. So that's where Giovanni comes in and is really an awesome partner. Flash forward to the end of 2021, and in October we do this soft launch of, "Hey, I'm gonna go full-time. Can I fill out some consulting hours?" And it happens like within that month, and so, I put in my six week notice in the middle of November. And then from all of November and December, it was just like this scary moment of having a one-year-old and quitting my full-time, stable position at LabCorp to go full-time into Project Medtech. So yeah, that takes us to Project Medtech and then I can tell you about where we're at today and that kind of thing. Lindsey Dinneen: Yeah. I was going to ask you a little bit more about the consulting side of the business. I would love to hear your take on that. Duane Mancini: Yeah. Yep. So 2022, I go full-time in January. Aaron comes full-time in September. Rich comes full-time in August. We flash forward to where we're at today in 2023. We have 14 consultants on our team, a handful of which are full-time. The rest do part-time work with us. So what we did for our consulting group we had this theory that what startups really needed were fractional resources across finance, commercial, operations. And that's an overall business strategy and that's the areas we had originally thought in 2022. So we used 2022 to work with clients, continue to bring people in that were willing to give this three month old consulting firm a chance based on what we were telling them and the people we had on our team. And from there we spent all of 2022 really looking at trends of how we supported companies, were there are different things we were doing, were there similar things we were doing that we can be more efficient on? And so, what we came out of that year with was, there is a huge need for this. And what's appealing about the group is it's all under one roof, right? So if you go to a CPA firm and say, "I need fractional CFO support," they're gonna tell you they should be their next hire, right? And you're gonna go on retainer with them, and you're gonna pay for that person when you don't need them. Same with a commercial person, same with an operations person. And what our value is, is that it's a peel on, peel off service. If you don't need us, then you don't need us. If you don't need a person, then you sub another person in. And so our idea was we ride with that. We've built a consulting firm for medtech startup companies rather than a consulting firm that's built around generating as much profit as possible and tries to slam startups into how that consulting firm is run. And so we've done the opposite, which has been frustrating at times to try to scale. But in the long run it'll be super valuable and we think we'll have a unique value proposition for these medtech companies. Lindsey Dinneen: Yeah. Okay. So what I love about what y'all do, and to what you're saying is, it's so highly focused on coming alongside these companies who, they're probably founded by people who are brilliant at what they do, but they might not have the experience of a business background just to supplement that, or, we can't all be all the things as much as we'd like to be. So it sounds to me like the way that you all are able to come alongside and partner with these companies to provide them the support they need at the time they need it, is a brilliant offering to the community. Duane Mancini: Yeah. That's a big piece of it, right? Startups don't need more advisors. Like they don't need more people to be coaches or tell 'em where to go dig the trench or how to climb the mountain. They need that, but they also need people who are gonna get in there and execute the game plan with them, or go dig the trench, or go help them climb up Mount Everest. Right? Like they need those individuals too. And to our knowledge, there was no organization that did both of that. And so that's what we set out to be for these early stage startup companies. And I think at first we thought we'd be a great fit for first time entrepreneurs and then we started to look back and go, well, we have a lot of first time entrepreneurs, but we also have a lot of entrepreneurs who are on their second, third, fourth company who are like, "Yes, I need you" because they know the power of the team. And so, what we end up becoming for these people is filling in the gaps. We become their extended team members. And, to take that one step further, what we've eventually found is that our core areas were finance, where we're supporting budgets, proformas, cap table dilution scenarios, but that was spilling into operations where we're doing supply chain logistics and bill of material support and helping to be that internal owner for the startup company as they talk to groups that are contract manufacturers or the suppliers or your quality systems management. The CEOs of these companies don't have time to be managing that. So we were fractionalizing that role and that spilled over into product fit, product messaging, and go to market strategy, and commercialization, and how to sell to a hospital system, and actually where we can put a fractional sales leader in place for you until you can go out and hire that first time salesperson. And that's spilled into investment strategy where we've built a great investment network, but we understand how to build pitch decks, executive summaries, how to target what investors you wanna raise from and why you wanna raise from those individuals. How do you do that? We help with warm introductions and then that kind of just spills over an overall business strategy because we have this end-to-end service where we can help you think about, okay, your regulatory consultant's telling you this but that's gonna affect reimbursement, which is going to affect your clinical strategy, which is gonna affect your commercial strategy. And so we are those early consultants who understand all those things, but then we'll go help you execute those things that you can't execute on your own. And our model is incredibly flexible, right? We meet the startup where they're at. And again, that makes it harder to scale, but that's okay because we're laying the groundwork for a company that just will know how to work with startups over time. It'll just take a little more time. Lindsey Dinneen: Right, exactly. That's awesome. Duane Mancini: Yeah. And then beyond that, we do events. And so our whole thing with our events group was, we don't want to go be another conference that's already out there. So how can we differ ourselves? So last year we did our Startup Symposium. We're going back to Houston in October of this year, October 25th and 26th, 2023. The whole idea from the Startup Symposium is we want to take companies from back of the napkin through exit with panel discussions on all the major topics that need to happen from ideating the idea all the way through exiting the company. And so that's exactly what we set out to do. And then we sprinkle in pitches from startup companies all within that timeframe, plenty of networking sessions. And really the whole goal was, okay, let's connect this ecosystem. A lot of times startups get hung up on "well, I need to be in front of 10 investors." No, you don't. You need to be in front of 160 medtech nerds who are going to take what you need and connect you to the rest of the ecosystem. And that's true value. And so that's what we set out to do and that's what we did last year with our first Startup Symposium in Houston where we had 160 people from Singapore to Australia to all over Europe, to coast America, all in Houston, Texas for a couple of days. And so, that's our one event. And then our second event we're gonna do this year, which is actually before that one is in August. That's a little more of a passion project for me. I'm an Ohio guy. I grew up in Youngstown, Ohio, on the east side of the state, went to school on the west side of the state in Toledo for my bachelor's and masters, and then now live in Cleveland, and so love the Midwest. And so we're going to do a Midwest showcase where the idea is to show off the innovation, connect the different startups, innovators, service providers, companies in the healthtech, medtech ecosystem from western PA, all the way to Iowa, up to Wisconsin and Minnesota, even South and North Dakota, Michigan, Illinois, Indiana, Ohio. And just connect those regions where there's some really cool innovation going on. They don't happen to be in Boston or San Francisco where most people think of Medtech hubs. Yeah. That's more of a passion and just wanting to do our part in connecting the regions. Lindsey Dinneen: I love that. Well, as a Kansas City gal for 10 and a half years, I fully support this endeavor. Duane Mancini: Yeah, exactly, right. Yeah. So you get it . Lindsey Dinneen: Yeah, I do. And it's exciting to see because there are really great companies and there is an ecosystem in the Midwest, but it doesn't have the same visibility always or maybe the same options, cuz trade shows tend to be on the coasts. Yeah. So this is exciting. Very cool. So if we were to rewind and let's say the start, either the end of 2019 or the start of 2020, could you have possibly imagined what this would have become by today? Duane Mancini: Oh, no, not a chance. I tell all the co-founders and the advisors, that I couldn't imagine being here right now, where we have an office space in downtown Cleveland that we work out of. And it's pretty surreal just because it started as a podcast and I, I think I originally said it was like, "Hey, five year plan, I'm gonna go full-time into this." And then it was, "well, maybe it's three years." And then it was, "well, we'll launch a consulting practice and I'll go full-time, but you guys come full-time in a couple years. Let me build this more." And then nine months later, they're both full-time. And so it's, yeah every step of the way we've far outpaced where we thought we'd be. And every time there's another milestone, I always think it's further off than it is. Lindsey Dinneen: Yeah. That's pretty cool. And I love to hear that kind of success story. It's nice to hear that, because everyone's story is so unique, but it doesn't always have to be the slow burn. Sometimes it can just be a rocket ship, I guess? Duane Mancini: Yeah. And well, and like to your point too, like, the slow burn, we always looked at as, we were as risk adverse as possible, right? Like no risks, or at least not as big of risks, each step of the way, right? And we've bootstrapped this, so we're different. We didn't raise any money. And so that's made it a little more challenging as well. But we've also felt like each step of the way, it was as de-risked as it could possibly get before it's " okay, well you either gotta do it or don't do it." And so it's been a wild ride. Lindsey Dinneen: Yes. I can only imagine. Yes. Well, so I am curious, is there a moment or maybe a series of moments that stands out to you? It could be with what you're doing now, but it could be in the past. I'm just curious, is there anything that particularly stands out to you as confirming that yes, this is the right industry for me? Duane Mancini: That's a good question. Yeah, I would say back to the early NAMSA days. My background is theoretically set up for more of a pharmaceutical background, but when I got into NAMSA and then worked with with so many different companies, so you got to see so many cool products. There was one that stood out in 2015, and we had done the biocompatibility for a company that was working on a disease where kids are born and their esophagus doesn't connect to their stomach. And so there was a lot of surgical procedures done, but this company had developed magnets that you essentially do one procedure where you inserted in the stomach, inserted in the throat, and then eventually the esophagus and stomach would fuse together. And we did the biocompatibility for that, which is like a small piece of medtech innovation. But I remember getting that story where they did it at their first clinical trial and the baby had two procedures and went home in seven weeks, which was like unheard of for this type of condition. And some of those details could be butchered a little bit. So no one hold me to it, but that was the general concept of it. And I just remember feeling like a sense of, "that's pretty cool how that paid off and I had a part to play in that." And from there on out, it was just like an absolute addiction to the industry of, "wow, we can make a lot of big differences in people's lives here." And, part of it was like, saying it tongue in cheek, but I used to be like, "what better industry than where I get to wake up every day and just save people's lives, affect people's lives in a positive way." And, it's part tongue in cheek, but it's also serious. Like we all play a really big role in affecting people's lives in a really positive way that we don't get to see all that often cuz most of us aren't on the frontline of treating patients like the clinicians are, but we're giving them the tools to do that. And so, that was the earliest time I can remember where I said, "oh I'm gonna be in this for the long haul." Lindsey Dinneen: Yeah. Oh my gosh. What a powerful story. Thank you for sharing that. I can see how that would easily cause a healthy addiction to the industry. Duane Mancini: Yeah. I should say healthy addiction. Right? And cuz there's other things that are probably not so healthy, but that's one of them. Lindsey Dinneen: Right, right, right. Yeah. Yeah. Absolutely. Well, throughout your career and of course now being the primary founder or the first founder of your company, you've had opportunities to demonstrate leadership and be a leader within the industry. How would you define leadership? Or what does it mean to you? Duane Mancini: Yeah. This is something too that I spent a lot of time, especially like stepping into the role of, I founded the company, but then it was discussed that I was gonna be the CEO and take this primary leadership role. And I think that it was something that I took really serious about, okay, well how do I want to be a leader and part of it was, okay, I want to be hands off-ish. I want people to feel like they have their creative freedom to, to take an idea and run with it. And I've tried to instill that from the very beginning of, "Hey, here's my ideas. What are your thoughts on this? Take it back. Take your time. Add to it." It's a free space to put your idea out there and let people do what they're good at. I think sometimes people fall victim to, "well, I'm the leader, I have all the answers." And you don't. You have to know where you're weak and put stronger people around you to fill those types of gaps you have. So I've made a pretty big effort to try to do that. And I think if you met Aaron and Rich you'd totally understand. We all excel at different things and Project Medtech doesn't happen without all of us. And so, I think, being humble in that sense is pretty important, which I see a lot of people struggle with, where they think they have to have all the answers, they want to do it by themselves, and that's not fun. Doing it as a team, that's fun!  Yeah, so that was the early thoughts around leadership and then, a lot of it was, just little things here and there that you pick up on, you read about. I, I did a lot of reading around psychology and how people make decision and what motivates humans. And I did a lot of reading from folks who did a lot around decision making and thinking and they did a lot around behavioral economics. And so, I spent a lot of time reading those books and thinking about those. And, it's funny how little things stick, but there's a video that floats around one of the social media platforms, one of the short videos that talks about how the Navy Seals make decisions on who they want on their team. So this guy draws a graph on the whiteboard and says, on one of the lines, it's "performance." On the other lines, it's "trust." And it says, obviously you want high performance, high trust. Right? That's an ideal person for your team. But then he says, "you would think that performance would be more important." But one of the most organized organizations in the world, the Navy Seals, actually would rather take high trust, medium performance, and even potentially high trust, low performance over a high performer with low trust. And that was something that, I watched and like anything, I'm a scientist. Every time I see something like that, I question it. And then I thought about it more and I'm like, "wow, that's actually makes a ton of sense." And so that was something that we talked about from the very early days of even adding 1099's of, they could be a high performer, low trust. We just have to identify that really quickly. But we'd rather take those high trust, medium performers cuz they're gonna make great consultants as well because the clients are gonna like them. And so we thought about those types of things really early on too. And that was a video that I just always go back to. The only difficulty with that is there's metrics out there to measure performance. There is not a ton of metrics out there to measure trust. And so that's been the issue of like right now, trust measurements is kind of on gut, and that's not the best formula. But anyways, that I wanted to share that because we have a whiteboard here I'm looking at in our office and we draw that graph on that whiteboard more than anything else to talk about people we're thinking about adding to the team and whatnot. Lindsey Dinneen: Amazing. Yeah. And so, if somebody were to be interested in obtaining a leadership role within the industry, potentially even follow a path somewhat similar to yours in terms of founding a company or something like that, what would be your advice for that person? Duane Mancini: Yeah, so I, I'll give you the advice that-- so Tim Blair is one of our advisors here. He's a consultant for us, but he is also someone that is an advisor for me as well and the company at Project Medtech. His dad, Jeff Blair, was the CEO of NAMSA at one point in time. And Jeff was a guy I talked to while I was at NAMSA and I talked to him a little bit and I got sit down with him for just a 30 minute discussion and I said, "Hey," I said "this is what I wanna do with my career." And he said, "you better go learn how to sell." Cuz I was a technical person who was stepping into technical sales and he said, you have to go learn how to do true sales and business development if you want to be a leader at a company," which is what I really wanted to do. And so that is my piece of advice for folks who are in the space, that are maybe in a technical role who want to get into leadership. They may have a low opinion of sales because I know I did before I was in it, right? I was that scientist who was like, "what do we need salespeople for?" And then, I get into sales, marketing, business development, and I was like, "oh my gosh, I was such an idiot. I was so wrong." That was advice that I look back and go, "yep, a hundred percent, totally get it." You have to go do that. Because if you don't have those skills or haven't done that, running a company is gonna be really hard because when you're running a company, you're selling internally and externally all the time, and so you better learn how to do that. Lindsey Dinneen: Yeah. Yeah. Great advice. I can definitely understand, and it is funny, I have talked to people who are quite skeptical of sales and marketing sometimes, and coming from a different background and I try to gently remind them, "well, the thing is if people don't know your product exists, they can't buy it." Duane Mancini: Yeah, right. A hundred percent. I mean, like even take an example, not related to medtech, but if you look at the Apple iPhone versus like an Android, right? I think most people who are really tech savvy or are engineers who really understand it will be like, "oh gosh, the Android is so much better than the iPhone from a performance standpoint." But the iPhone owns the majority of the market. And it wasn't because someone built a better product. It's because their sales and marketing and their brand development was that much better. And they own the market for that. I brought this up one time and someone brought up the example of, I think it was like an 8 track or cassette or something like this, from like in the past with music. And it was another example of like someone had a superior product, but the branding and marketing of another product that maybe wasn't superior, crushed them. They eliminated them out of the market. And so, that is always the truth is that you have to have those sales and marketing people and you have to be good at what you do there. Lindsey Dinneen: Right. Yep. Unrelated a little bit, taking a turn, imagine someone were to offer you a million dollars to teach a masterclass on anything you want, doesn't have to be in your industry, but it could be. What would you choose to teach and why? Duane Mancini: Good question. I think I'd probably honestly stay in medtech, stay in the masterclass of everything you need to do to make this medtech company successful. I think I have to stay there. I don't think I know enough about anything else to teach. I think that's my issue there. I'd love to say what worked for me for staying motivated or a lot of the mental things I've read about or like having a really, worry free kind of mindset. But that's just what's worked for me, and there's other experts and it's just been like I've pulled that from so many other people. I'd probably have to stay in Medtech, I think that's where I have to sit. Lindsey Dinneen: Yeah. Well, hey, and you live it, so that's a great one to do a masterclass on. Duane Mancini: Yeah. Yeah. Yeah. Lindsey Dinneen: What is the one thing you wish to be remembered for after you leave this world? Duane Mancini: Well, one, I hope that my daughters remember me as a great father, first and foremost. So, we have our second daughter on the way. I will tell you that being a father and even maybe more specifically, like to my two daughters, has just absolutely changed me as an individual: way more sensitive, closer to my emotions being just a dad in general. So hopefully, that's first and foremost, is that they look back and go, "yeah, boy, dad was awesome." That'd be my first thing. And then after that, Project Medtech has consultants. We're not gonna be remembered for bringing a specific product to market, right? That's gonna be that founder. But just the fact that they made a difference in, in helping innovators bring really good ideas to market. And that's what I want to be remembered for personally is that I helped play a role in allowing people that have really good ideas to see their idea through to as far as they want. What kills me sometimes is when an innovator has a really good idea and they don't get to see it as far as they wanna see it, right? When they're forcefully said, "Hey, some other CEO needs to take this role, or someone else needs to take the leadership reins" and they wanna do that. I don't want that ever to be the case. I want it to be that they've made that decision cuz they had the resources to do what they wanted to do. And so I just wanna play my role in, in bringing innovative products to market to improve patients' lives. That's the mission of Project Medtech. So, I guess in a way, if you're gonna be the founder and CEO of a company, that mission better be something you personally live by. And that's a hundred percent what I wanna be remembered for. Lindsey Dinneen: Yeah. Yeah, that makes a lot of sense. And it's really cool that you get to live that out now, you get to see impact that you're making in various peoples' and various companies' lives because of the role that you do get to play. So that's pretty cool. Duane Mancini: Yeah. Yeah. Yeah. Lindsey Dinneen: Well, this will be the final question, but I am curious to know how it's gonna tie in. So, what is one thing that makes you smile every time you see or think about it? Duane Mancini: I'll stay on the same track. It's family for me. Family and friends, which I bucket together because anybody who knows me will tell you that like my group of people that maybe aren't blood related, are still family for me. And so that goes all the way down from my wife, to my kids, to my parents, to my in-laws, to all of my friends. That is the one thing that just consistently brings joy to me. And then in the most cheesy entrepreneur way, it's Project Medtech and the development of Project Medtech, and more so the companies we are supporting and when they have success. I'd love to see the success of Project Medtech, but even more so when a company hits a milestone or raises funding, gets to market, sells into a hospital, benefits a patient-- that's honestly for me, even a bigger moment to smile than the success of just Project Medtech because that's why we're here is to support those companies. And so, that's more than one, but those are those three things that consistently bring me happiness and make me smile. Lindsey Dinneen: I love it. Great answer. Thank you so much again, so much for joining me today. I really appreciate your stories, your insight, your advice. It's really cool to see Project Medtech's story, and I just thank you again for sharing it with all of us because it's very inspiring and it's so cool what y'all are doing, so I really appreciate it. Duane Mancini: Yeah, thank you. Yeah, thanks for having me. Thanks for starting your podcast series as well. It's funny, one last comment is, I talk to so many people who think starting another podcast would be competitive. And it's not, right? There's how many billion people in this world? There's a lot of ears for us to reach out to. And so, I always think it's so cool when people are starting podcasts in the industry and especially on more of the human side of things like this, Lindsey. I thought you did a fantastic job on the interview and just making me feel comfortable, which I know is not easy to do as the sitting on the other side of the table. And I think the more of these things that exist where people can actually get to know folks in the medtech space like this is really exciting. It makes the industry a little bit closer. So kudos to you for taking the plunge and starting this podcast. It's a heavy lift. Lindsey Dinneen: Well, thank you. I really appreciate that and I value that feedback too. Well, we are honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational, and safe environment. So thank you very much for choosing that organization to support. And of course, I just wish you continued success as you work to change lives for a better world. Duane Mancini: Thank you. Lindsey Dinneen: Absolutely. Thank you also to our listeners for tuning in and if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two and we will catch you next time.  The Leading Difference podcast is brought to you by Velentium. Velentium is a contract design and manufacturing firm specializing in the development, production and post-market support of diagnostic and therapeutic active medical devices, including implantables and wearables for neuromodulation and other class three indications. Velentium's core competencies include electrical design, mechanical design, embedded software, mobile apps, contract manufacturing, embedded cybersecurity, OT cybersecurity, systems engineering, human factors and usability, and automated test systems. Velentium works with clients worldwide from startups seeking seed funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.