Podcasts about medtech innovator

Maria Artunduaga is the founder & CEO of Samay, the winner of the 2024 MedTech Innovator accelerator, as well as a groundbreaking physician, scientist, and inventor. Maria discusses her inspiring journey from a small town in Columbia to leading a top MedTech company in the US. After pivoting away from plastic surgery training, she channeled her efforts into creating Sylvee, an AI wearable sensor for COPD patients. Maria shares her relentless determination, innovative problem-solving strategies, and the creation of a company culture that emphasizes learning and diversity.    Guest links: https://www.samayhealth.com/home | https://www.linkedin.com/in/drartunduaga/  Charity supported: ASPCA 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 057 - Maria Artunduaga [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 delighted to welcome as my guest today, Maria Artunduaga. Maria is a physician, scientist, and inventor with 60 plus prizes, including becoming the first woman to lead a US LATAM company to win MedTech Innovator, the world's most competitive accelerator for medical technology surpassing over 1300 global companies. A top 1% student in Columbia, her country of birth, she relocated to the US to pursue plastic surgery training, but abandoned it to dedicate herself to solve the problem that killed her grandmother-- a lack of home technologies that can detect COPD exasperations early. Maria has raised 5.2 million, almost 60% in non-dilutive capital from NSF and NIH to build Sylvee, an AI wearable sensor that can provide COPD patients with continuous data on pulmonary functions similar to what continuous glucose monitoring sensors do for diabetic patients. Her invention has been featured by a hundred plus media outlets, including Forbes, TechCrunch, Bloomberg, Fierce Healthcare, and more. Before Samay, Maria completed postdoctoral studies in human genetics at Harvard Medical School, started a plastic surgery residency at the University of Chicago, and completed two master's degrees, one in global public health at the University of Washington, and another in translational medicine at the University of California at Berkeley and San Francisco. She lives in Mountain View, California with her husband, 2-year-old daughter, and four pets. In her free time, she enjoys flamenco dancing, bolero singing, traveling the world, and fostering diversity in and outside the workplace by mentoring underrepresented scientists and entrepreneurs. All right. Well, thank you so much for being here, Maria. I'm so excited to finally get a chance to speak with you. I'd love if you would share a little bit about your background and your career trajectory. What led you to MedTech? [00:02:40] Maria Artunduaga: Sure. So it's gonna be a little long and I'm gonna tell you everything about my life because the personal history is very important to me and for my company too. So, as you have noticed, I have an accent. So, I grew up in Columbia in a very small town in the southern part of the country. My parents were both doctors and I'm the oldest of four kids and two of us followed their lead. So my life in my city was pretty chill. Everyone knew everyone. I spent most of my days at a Catholic school studying very hard on weekends where I usually spent tagging along my parents to doctor events. One of the things that I really like to tell, it's how my parents work as entrepreneurs really shaped my life. They were real pioneers. They built in my hometown the first big clinic back in the eighties and the nineties. And my mom was the only woman in that group, and she actually was the CEO for a while, which was a big deal. She was the only woman in a partnership of 10 people. And watching them build that clinic, that hospital really taught me a lot about dealing with uncertainty and finding solutions. Every day we'll have supper or lunch and I'll just hear all of these challenges and stories, their struggles and how they solve things. Something that was, that is definitely super helpful in what I do now, right? So, and then I was 16 and after high school I moved to Bogota, the capital, which is up in the mountains, it's very cold. I got a scholarship 'cause I was always a very good student. You know, career I spent my last year, I spent nine months in the US. Honestly, coming to the US blew my mind. The technology that I got to see, the speed, effects on science, it was nothing like I've ever seen before, and that was true inspiration for me. So I knew that I had to come to the US. I needed to come back to learn from the best, of course. And it's interesting because my parents didn't want me to relocate to the US. I was the oldest. I was supposed to follow into their footsteps and obviously, like inherited that clinic, right? That hospital, we call it clinic, it's actually a hospital. And I was a very contrarian. I didn't listen to them. I told them, you know, I really wanna be where the best people are. And what I did was that I, it took me three years to save the money to come to the US, to get Harvard to actually sponsor me my visa because they wouldn't pay me for the first year. So I remember I had to save $30,000, which in pesos is significant. So back in 2007, so many years ago, I made it to Boston, and the original idea was that I wanted to become a pediatric plastic surgeon and bring that level of care back to Columbia. I spent four years of researching a genetic ear condition that's called microtia. And with that work, I was able to land a plastic surgery residency spot or position at the University of Chicago. And I shared this with a lot of people. I actually had a really negative experience. Things didn't go as planned. I actually faced discrimination. I eventually, you know, had to leave and I made the top choice to never ever go back into clinical practice. And I changed paths. I was 32 years old and yeah I decided to switch gears. I retrained into public health and tech. And then in 2016, I moved to the Bay Area where I am right now. And I got another scholarship to finish master's in translational medicine at UC Berkeley and UCSF. And during the courses that I took, some of them with business class etc., etc., I decided to found Samay in 2018. I really wanted to build something that would really make a difference in respiratory medicine. And this is where my grandmother comes. So my, the grandmother, my abuela, her name was Sylvia and she had Chronic Obstruct Pulmonary Disease or COPD and she's the reason behind my company. So, she often couldn't tell when her symptoms were getting worse. That's a huge problem. Catching the respiratory attacks, exacerbations is definitely key to keeping people outside of the hospitals, and obviously feeling their best to have a better quality of life. So, that's what we are trying to solve with a company, right? If we are able to catch those exacerbations even with a day or two notice in advance, right, that we can all make a difference. And so by missing these exacerbations, we are having really high expenses in hospitalizations and ER visits and the problem we trying to solve is that today technologies that are adequate enough to be used outside of the hospital because the ones that are considered to be the gold standard, they are very expensive. They are confined to their hospitals and they are very difficult to complete for the patient, especially when they're exacerbating. They need to blow out forcefully for about 10 seconds, 21 times. So what we are doing is, we are developing a sensor that makes it super simple for people to use it at home to track their lung function without doing those forceful maneuvers and ideally in the future to warm them, right? Like to let them know when things are starting to go south or obviously, you know, not going very well, and that's what it's all about. I mean, that's what we do with Sylvee right here. And it's wearable sensor and we have done significantly well over the past couple of years. We actually just won MedTech Innovator. [00:08:04] Lindsey Dinneen: Yeah. Significantly well over the last few years. Yes. So congratulations on that, and I want to dive into all of those exciting milestones in just a second. But I am, first of all, so inspired by your story. Thank you for just sharing that your resilience and your grit and your determination are really admirable. So thank you for sticking with something that was not easy, not an easy path. [00:08:29] Maria Artunduaga: I know. I know. [00:08:31] Lindsey Dinneen: It continues not to be, ironically, as we've kind of touched on before, but just going backward a little bit in your story. So I, it sounds to me like getting the opportunity to watch your parents have this incredible impact on their community and the healthcare and the opportunity is just so valuable for you. And even just learning about how your mom was the CEO and those kinds of things, did that help shape the idea for you that not only is entrepreneurship possible, is innovation and healthcare possible, but you can also be this in incredible leader as a woman in whatever capacity? I would just love to dive into that. [00:09:13] Maria Artunduaga: Yeah, it's super interesting, right? My mom really taught me a lot about leadership. She's a surgeon, so you can imagine how good of a leader she is in the operating room at home, everywhere, right? I mean, she's definitely the general, that's how I call her. And I honestly, I try to replicate, so my leadership and styles pretty much shaped by her. So I always call her my best role model whenever somebody asks me about the question, right? So I'm just like her. I lead from the front. I like setting the pace by working the hardest. So I really like to lead by example and I also, just like she did, and obviously because of her surgical training, I hold myself to a really high standard, and I expect everyone on my team to do the same. So people in my company know that I'm very strict, I'm very disciplined, and they know that from the beginning. It's so funny because when I interview all of them, at the final interviews with me, and I actually do the anti sale to join Samay. It's like, this is, these are all the reasons why you shouldn't join. I start describing myself as a very intense, obsessed CEO with insomnia, which I still have, because I really wanna make this work, right? So, yeah, I, ask them, and most of them say yes. I really like, I attract people that like challenges, especially intellectual challenges. So, yeah, to this point, most of them say yes. Some of them have obviously, you know, because probably too much. But at the same time, I tell them, "Look, this is going to be very hard in terms of the deliverables, the things that we're expecting from you." But at the same time, my goal is to not only help people with respiratory problems, I try to sell the company as a company where everyone that gets hired can be themselves and thrive. So, so for example, I tell them," Look, I'm trying to be the boss that I never had." And this goes obviously very tied to the very negative experience that I had during my surgical residency and even before, right? So, I never had a boss that really supported me, who recognize my true self and those characteristics as good things, right? So they always try to tone me down. I'm very energetic, as you can notice, and I'm also super ambitious. I'm really ambitious. I wanna do all of these great things. And they always thought that I was aiming for too much, especially for a woman. It's like, " You need to lean in, Maria. You need to behave." So I remember my residency, they were criticizing like, "Why are you behaving like this, Maria? Why are you asking so many questions? You're asking too many questions. You look more as an internal medicine doctor. Why are you always smiling, Maria? Why are you so happy?" So now, with everyone that I hire, what I try to do is that I focus on understanding their dreams and I try to figure out how this job is gonna help them get there. So if they wanna become a top engineer, maybe they wanna learn managerial skills, or they wanna run operations, or they eventually wanna become a founder themselves. So I try to create a partnership with them where they obviously help me succeed with the company, build Samay, but at the same time they get to do this personal growth. So it's extremely important that they get to place where they wanna be. [00:12:32] Lindsey Dinneen: Yeah, that's wonderful. And such a gift to your employees. And I also honestly, that sort of anti interview or whatever technique is brilliant because you do want it to be a fit for everyone, and it's so much better to have aligned expectations from the start. So, oh my goodness, that's so interesting. So, okay, so then. Speaking into that, how do you develop a company culture for yourself? You've learned from some pretty negative experiences, so obviously that's what not to do, but you know, as you're crafting your own company culture now, what kinds of things are sort of your core values, other than of course, your hard work and your excellence and holding yourself and others to high standards, but what kinds of things do have you developed that make it special to be where you are? [00:13:19] Maria Artunduaga: Yeah, I mean, that's a really good question. I'm very true to myself, and one of the things that I wanna do with Samay, it's I wanna create legacy. If you go to my WhatsApp, that's exactly the little logo or the slogan that's below my name: I'm creating or building my life's legacy. That's how I pitch myself. So I really wanna be remembered as someone that made healthcare more accessible, especially for the people that get left behind. So growing up in Columbia, I saw firsthand how unfair things will be and I wanted to change that. So that's how the values of Samay go, people first. I think legacy, it's extremely important, right? It's about getting those life changing tools and opportunities into the hands of people who really need them. And again, it's not necessarily, the group that we're building. It's the own experience of building a company with me, learning from the company, from the people that are working with. I really wanna make it accessible for people. And I wanna also be obviously a source of inspiration. You don't necessarily need to be this perfect person to be a CEO. You know, life is a struggle and that's totally fine. Just be very passionate about building legacy, right, your work and how you're impacting other people. And especially for me, I do a lot of work with women and minorities. I really wanna empower them to chase their dreams in science and technology. I really care about people. I don't know, I'm selfless about me. It's all about the others and creating legacy and being remembered. So, yeah, that's how I, that's how I roll. [00:14:59] Lindsey Dinneen: I love that. I love that. So speaking of you embracing the CEO role, when you first started your company, did you feel ready to step into this kind of position? Or was it something where you just were like, "You know what? I see the need. I know I can make a difference in this field. I'm gonna do it and I'll learn along the way." [00:15:19] Maria Artunduaga: No, not at all. And let, so there's a very good anecdote that I'm sharing. Again, back to all of these life changing experiences. I got into medtech because of, I don't know, somehow the planets got aligned, right? So I was doing a master's in public health because I thought that was going to be my real call, working for Gates in Seattle, because that's where I actually lived for about two years. Then I came to realize that it was very bureaucratic. It's very, was very slow. I have a type A personality. I really like to fix things very quick. I like to implement stuff. So I decided to do a second master's degree, and as I mentioned, here in Berkeley, I decided to join one of Atma METs minority programs for students, right? It's called SMDP. And I remember that was back in 2016, and they sent me to Minneapolis for the big conference. And that's where I got my first real taste of MedTech. And I remember watching the MedTech Innovator finals with Paul Grand. He was introducing the program, the finalist. I remember clearly seeing all of his pitches and how Green Sun Medical CEO won, and it was a game changer to me because when I saw them pitch, it was very exciting. You know, all these technologies, the many millions of people they could definitely impact, I saw that, and it clicked. I could turn the scientific ideas into something that helps millions in a way, the way how I would practice medicine, but in a more impactful way. So interesting story though. So the other thing that was very inspiring or at least that motivated me, I was the only person in the room who looked like me and spoke with an accent from South America, from Latin America. So it was like two reasons behind it. For me, it was I wanna be a medtech entrepreneur, but at the same time I wanna be able to break the glass ceiling, right? The first Latina physician CEO building a company that has hardware, software, and AI, this is what we actually do. And yeah, so it, it's mainly that. I really like challenges and I'm very motivated to show people that I can do things that might seem impossible or too difficult. So I really like showing people that anything is possible with a lot of hard work and determination. So yeah, that's mainly it. [00:17:47] Lindsey Dinneen: I love that. Embracing those challenges, running full steam at them and having that, I don't know, that gumption is fantastic too. And the desire, like... [00:17:57] Maria Artunduaga: Thank you. [00:17:57] Lindsey Dinneen: ...you said, to break through those ceilings and to represent and say, "No, it is possible." It is, and I love that. So, excellent. Okay, so can you share a little bit about the journey that the company has gone under recently and some of the really exciting milestones? I know there have been bumps and whatnot, but maybe some of the exciting things that have been developing and what you're looking forward to as you continue down the road. [00:18:24] Maria Artunduaga: Sure. I mean, whew. There are so many things that have been happening for the last couple of months. So it's been a long journey. It's been six years so far. Initially, you know, I wanted to build a company with an idea that was inspired, obviously, by the fact that I lost my grandmother to exacerbation and also because, at the time, I didn't know what I wanted to build. When I was doing an interview with a pulmonologist, what I realized was that I could actually build a technology that could be inspired by consumer devices, so hearing aids for example. And funny story is that my husband who is also Columbian, and went to MIT, he's been working at Google for over a decade and he's an auto engineer. He does a lot of things. He's very smart and he's one of the main architects. What I decided to do back then was, let's repurpose hearing aid technology by sending signals through the chest, and let's use the physical principle of acoustic resonance to understand what's going on inside of the lungs. And that's exactly what we are doing. We have 10 granted patents so far. We have 20 more pending on pulmonary so far. So we've done a lot of things. So we've tested that device on 450 people almost. All of our numbers of accuracy are over 90. Sensitivities and specificities are also between 82 to 98. Right now we are starting to see changes a few days before an exacerbation is actually diagnosed by a physician, which is extremely exciting. We have data from two people. Obviously it's a small sample size. We are following eight of them, and we're aiming to finish at 60 to hundred people in the next year or so. So that's our main goal. We've raised 5.2 million, 60% of that money is coming from grants, federal grants, and we just submitted a breakthrough designation to the FDA about a week ago, so fingers crossed, though, we get it right? There are a lot of things in the pipeline, things that are very exciting. Right now I'm super excited 'cause those six years were very hard. I was running a science project with my nails, getting money from grants, help from people who have known me forever. It was very hard for me to recruit a full-time CTO. So my husband has been helping me with some hours here and there. And we have right now 12 people in Columbia. So for developers, designers, clinical researchers, we are running most of our operations in Latin America because it's extremely, well, obviously cost efficient, and more importantly, we have access to people that are patients especially that are, that exacerbate more often. So we are to leverage all the different angles that we can get. [00:21:04] Lindsey Dinneen: Yeah. Wow. So lots of exciting things in the works and in the future, and oh my goodness, I'm so excited, can't wait to continue to celebrate all those wonderful accomplishments. So I'm curious, as you've taken this journey and even before with your other health experiences and finding this path, are there any moments all along the journey that really stand out to you as affirming, "Yes, I am in the right place at the right time, in the right industry." [00:21:31] Maria Artunduaga: Yeah, beyond the MedTech Innovator, the experience eight years ago, I mean, every day I find that this is the perfect fit for me. I always tell people, "Look, entrepreneurship is not for everyone. It really needs to be a fit of personality." So when I talked to my parents, because at the beginning they weren't very agreeable with the idea of me becoming an entrepreneur 'cause physicians don't do this, right? I was sort of like a black sheep of a family, 'cause my sister, she's successful and she's a pediatric radiologist as she's working for an academic center in, in Dallas. So, my personality, I'm Type A. I'm very anxious. I really like doing things super fast. I really like to get things done, right? So, I dunno if I picked the wrong career, probably could have done a better job as an engineer, as a scientist myself. So at heart, I'm a true scientist. That's what I really enjoy. I like practicing medicine, sort of miss it a little bit, but I'm more in the quest of solving questions and discovering, right? That's what really excites me. And then, every day is a new day when you're building a company. And the challenges that I have every day, all of the problems I have to solve, I really enjoy the process of solving them. And this is a little crazy. Who gets excited with problems, right? So, I don't know, that's probably me. So I guess every day, the moment I go home or that I go to sleep, I say, "This is perfect. I don't think I'll be as happy as I am right now if I had stayed medicine. I don't think so." [00:23:10] Lindsey Dinneen: Wow. And that says a lot. And that just affirms to you on a daily basis, "Yeah. I am doing what I'm supposed to be doing. That's wonderful. [00:23:17] Maria Artunduaga: Exactly. Right. It's like, yeah, I'm good at this thing. You know? I like solving problems. I got, I really enjoy the fires. I really like them. I's like, I don't know. I'm, yeah. I'm addicted to them. [00:23:30] Lindsey Dinneen: I love that. Well, and that is unusual, and I'm curious, do you? But it's a great thing. No, it's a wonderful thing. Yeah, no, absolutely. I love that. So, so when you're at finding yourself up against a problem, do you start with any particular kind of established framework? Do you like to just brainstorm solutions? How do you approach problem solving? [00:23:53] Maria Artunduaga: Gosh, this is a really good question. It's like, you know, if I had to teach something, right? So I'm very good at solving problems, at connecting different disciplines, right, to solve those issues. So for example, the way how I go about them, first of all, I don't get frustrated or too anxious about it. I always try to think first, right? And then, yeah, I start brainstorming. I'm very quick at thinking, my mind goes super quick. I have a whiteboard right behind me. I do a lot brainstorming on my own. I ask a lot of questions too. So I rely on a lot of people, and I get a lot of feedback on the way, how I think a problem needs to be solved. And obviously with time and experience, the older that you get, the better you become, right? So yeah, honestly, every problem is different. I just like seeing it from different angles, right? I'm very good with social stuff. I'm very good with arts too. I really like doing science, learning a about engineering. I really like different ways of solving problems. For example, I remember that I we had this NIH grant and we were working collaboration with a big, famous academic center right here. And things weren't working very well. That was through during a pandemic and I was getting charged things that we actually didn't approve. So things were getting a little awkward. I decided to finalize that agreement. But then I got through this situation that I had no access to patients here in the States, and at the time, I didn't have my clinical site in Columbia opened up. So what I did was the craziest thing, which is what I did, was that I bought an $80,000 machine and I came into an agreement with a friend from medical school who has a pulmonary practice in South Florida, one of the largest pulmonary practices. He's a partner with nine other guys, and they see probably a hundred patients every day. Can you imagine that? So respiratory patients, and I told him, "Look, I don't have any money to pay your rent, but I'm gonna give you equity for that rent, and you're gonna use this machine from Monday through Thursday, and I'm going to test your patients from Friday to Saturday. And I'm going to bring people, I'm going to become my own CRO, right? So I'm gonna bring people, doctors, from Columbia on a J1 visa as a research scholar visa. I'm gonna train them and I'm gonna get them to do the recruitment, review everything, test the patients. We are going to become our own CROs, and we are going to do as many people as we can every single week." So we were able to do 430 people in a span of a probably a year and a half. Something that usually would cost us thousands of dollars. I dunno how much money I spend, probably just 300,000 to do everything. Can you imagine? I mean, that's significantly cheap compared to any other quote that I've been getting from an academic center. So, I sometimes go for the crazy idea, right? Like, what's the craziest thing that I could think of? I literally, I write it down, right? And then I just try to double check with my lawyer. "Am I doing something illegal here?" And I, yeah, I cross reference with other founders. " I'm thinking of doing this, how that's that sound?" And they're like, "This is pretty non-traditional, Maria, but I mean, if you can get it done..." I'm like, "Yeah, of course I can get it done." And I just get it done. I just don't take a no for an answer. I'm very good at also finding, convincing people to jump on board with the vision, the mission. This excitement, this energy, people really get very engaged with Samay and with me as a founder, and they love it. Most of these people either have invested in the company, they are helping me many more hours, pro bono, literally free, and we are building together. [00:27:43] Lindsey Dinneen: Wow, that is so cool. And what a fantastic story. Thank you for sharing that one as well. Oh my word. [00:27:50] Maria Artunduaga: I have way too many stories to share. This is the one I really like to, to tell people. [00:27:55] Lindsey Dinneen: I love that, and I love the willingness to come up with those crazy ideas. And it might be just so crazy that it works. So, hey, you never know until you try, and that's fantastic. Oh my gosh, I love that approach. Alright, so pivoting the conversation a little bit just for fun. Imagine you are to be offered a million dollars to teach a masterclass... I know! ...to teach a masterclass on anything you want. What would you choose to teach? [00:28:22] Maria Artunduaga: Yeah. So, good question. So, gosh, I, I tackle problem. So my, my brain again is very good at figuring stuff out. That plus the fact that I'm very stubborn. So if I'm into something, I don't give up easily. And now I'm gonna tell the story about our winning MedTech Innovator. We beat 65 companies globally, right? And I still like, sort of, I cannot process that we won. So the story goes like this, but a year ago, I tried to raise five millions, my very first institutional round, and I totally flopped. [00:28:55] Lindsey Dinneen: Oh. [00:28:56] Maria Artunduaga: I only got $200,000 because multiple funds that I was talking to, they wanted me to feel half of the round before weighing any money or signing anything. So you can imagine. So do I got, you know, chicken or the egg problem? I failed. And instead of crying or mopping, I thought, "Okay, wait. I got into Medtech Innovator. You know what? I'm just gonna win that competition, still $350,000." And why not? So obviously people, my advisors, my best friend, "Like, you're crazy. It's the most competitive thing ever. You're not established in the field. People know who you are, but it's not like you have exited a company or anything, right? You're not even an engineer, Maria." So what I did was, again I went back to my whiteboard. Again, I probably should have become an engineer before, I dunno. I'm really good at solving problems. So I was like, "You know, this is a problem. These are the different ways how I can tackle this." And more importantly, I'm very good at the studying stuff. I really like, again, knowing, wisdom, information. I just love that. I really love that. So what I did was, I treat it like a big project, and I talked to the past winners, anyone who had done or won any sort of like prize with MedTech Innovator, and I figure out their secret sauce. So I either talk to them, I studied every single video, every single pitch. I spend many hours studying everyone who had one or had done significantly well throughout the accelerator. So what I discovered was the accelerator was kind of a school, like a school. So the harder you work, the better you do. And one of the things that I realized was that mentors and reviewers were key players. So I focused on building those connections. I met with many of them. I probably spent about, I don't know, probably four to five hours meeting with mentors, anyone who I thought could help me somehow, obviously, for free, because a lot of the help that they give used for free. And I also spent a lot of time doing homework, the webinars, et cetera, et cetera. I ask a lot of people for advice. I really got people excited about Samay. I recruited my mentors and they got on board from day one. Because of that, I started building those relationships and it was authentic. I mean, don't get me wrong, this wasn't like, you know, I'm trying to play anybody. I really care about what they had to say, and I incorporate all that feedback into my company to this day. So the other thing is, I make sure to go to everywhere, every webinar, every event, everything. My camera was always on, because most people, when they do their webinars, they don't even turn on their cameras, right? So I was very engaged. I was asking questions, I was getting involved with everything. Same thing with the Slack channel that we have for MedTech Innovator. I was helping people, I was sharing stuff. I was even offering to make introductions. I really made sure that people knew who I was. And I obviously also asked the MedTech Innovator people, the staff, for help, feedback, right? Am I doing this right? What do you think I should do? Anything that you can share with me that you think. I was very clear with them. I wanna go to the, I wanna get to the finals. I told them, and I remember they telling me, "Oh, Maria, about getting to the finals, it's so hard. It depends on the strategics and the sponsors." And I was like, " I'm gonna get there. What do you think I should do?" So I literally ask a lot of people how I needed to get there. And with the finals, the way how they pick the finalist, it's actually the mentors who go in front of the strategics, and they sort of champion your company. And they really went to bat for us. They told them how committed I was, the many people that from my team were actually going for participating to the winner because I brought people from my team... [00:32:45] Lindsey Dinneen: Yeah. [00:32:46] Maria Artunduaga: You know, very few founders did that. I brought people from Colombia, obviously online, people who barely could understand English. But, I made them prepare questions. "You need to do this and that we need to be super engaged. We need to help other people." And they saw it was hard work. And at the end, we got into the finals and what I realized was, okay, so after the finals, I understood that the game was, obviously it changed. The way how the winner is chosen is that the audience votes, right, during The MedTech Conference. So what I did was, I went all in on social media. We made an awesome video for the best video competition. I remember that that was the first thing that I did back in June. I scheduled two weeks. I flew to Columbia. I hired right people. I made sure that I was perfect, so I was part of the creative team. I designed everything. Again, I really like arts, right? That's why, one of the reasons why I didn't, I was in pleasantry and that's why I really like dancing too, right? So I'm obsessive with everything that we do. I really am into the details and I supervise everything. And we also got into the finals for the best video competition. So I was going to this problem from every single angle. I didn't let anything up to chance. I, yeah, I'm a freak. I'm a control freak. That's what I did. I remember that even for the pitch, the four and a half minute pitch, I practiced, I don't know how many hours, but every single thing that I say that was obviously memorized, needed to be perfect. The way how I, let's go back to dancing since you're a dancer yourself, the way how I moved my hands, right? The way, how I walked on that stage, everything was rehearsed. So, yeah, I mean, I just I worked my ass off. I mean, everything was the way it needed to be and that's how we won. [00:34:39] Lindsey Dinneen: Yeah. Wow. That's great. What a fantastic story. Yeah. Amazing. Yes. I love how it's so choreographed. Yeah, that's [00:34:48] Maria Artunduaga: great. It was choreographed, [00:34:50] Lindsey Dinneen: I love that. Excellent. Well, I know you have touched on the importance of legacy and how much that means to you, but how do you wish to be remembered after you leave this world? [00:35:03] Maria Artunduaga: Oh gosh. Yeah. I mean, so I have a little daughter, I want to some somehow replicate the same experience that I had with my mom. Maybe she doesn't even realize how much of the inspiration and the impact that she had on me. And again, leading by example, I don't spend a lot of hours with my daughter, right? I have a nanny for 12 hours. So my salary goes to her payment, right? Yeah, I wanna be remembered as somebody who tried very hard, who literally, instead of saying things, I walked the talk. The things that I said I was going to say. For example, I'm very opinionated with anything diversity and inclusion because, as I've said, I've experienced discrimination myself. So I walk the talk, I build a product, I build the change. I worked really hard. I impacted a lot of people. And more importantly, the world has changed somehow because I existed. So that's that. It's as simple as that. I wanna help other people get to fulfillment of their lives and their dreams. And yeah, and I obviously wanna be happy while I do all of these things. And more importantly, I wanna feel that I learned a lot. I really like learning. The process of learning every single day, learning a new thing makes me super happy. So if I don't learn something new, I consider day as, you know, as like a flop or something. So yeah, it's very simple. I'm actually a very simple person, I'm not that complicated. [00:36:30] Lindsey Dinneen: Yeah. Okay. And then final question. What is one thing that makes you smile every time you see or think about it? [00:36:39] Maria Artunduaga: Oh, cute. I mean, obviously my daughter. So I'm a mom. I'm 44, well, almost 45, and I had her at 42. So just thinking about her makes me smile every single time. She's a miracle baby. She's, you know, after four years of IVF, eight retrievals, it finally happened. I finally had her, and having her in my life has turned my world upside down in the best way. She's determined, and she's only three. She's diving into doing all sorts of things. She's doing gymnastics, she's building Legos, she's doing engineering stuff. I really like that "I can do anything attitude" and obviously I'm sort of like reinforcing her to do anything she wants to try. So seeing her try all these new things, all this confidence that I, that she has. It's like, I don't know. I mean, that inspires me. That motivates me to be a better mom, a better CEO, and to do exactly the same thing with the people that I work with. So everyone in my company, I I tell them I'm a mom, right? So, remember that, and I try to do the same with them. It's like I tell them, what do you wanna do? What do you wanna learn this month? What do you need? Right? My work as a CEO is getting the resources and put out the fires. Just tell me, and this is your playground, so I'm trying to do exactly the same with my daughter too. But yeah, I'm very happy with her. [00:38:07] Lindsey Dinneen: Aw, that's wonderful. I'm so glad. Well, oh my goodness, this conversation has been amazing. I kind of wish it didn't have to end, but I also wanna respect your time 'cause obviously you have so much going on. But thank you so much for sharing about your story, your advice. You're so inspiring, and I know this is gonna inspire so many people to go for it, and not to have the fear, to have that problem solving mentality, and growth mindset and learning and, hey, look where curiosity got you. [00:38:37] Maria Artunduaga: Yeah, exactly. That's a perfect slogan. It's all about that curiosity and it gets you places. Look at me. [00:38:43] Lindsey Dinneen: Yeah, exactly. Yeah. And this is just the start. [00:38:47] Maria Artunduaga: Yes, of course. [00:38:48] Lindsey Dinneen: Indeed. So I just wanna say thank you again for your time today, and we just wish you the most continued success as you work to change lives for a better world. [00:38:58] Maria Artunduaga: Thank you so much and thank you again for invitation. I really enjoyed it. [00:39:02] Lindsey Dinneen: Yeah, absolutely. Me too. 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 you choosing that organization to support and thank you just again, so very much for your time here today. Yeah, and holy cannoli, 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'll catch you next time. [00:39:44] 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 this episode of the DeviceTalks Weekly Podcast, Host Tom Salemi talks with Dr. Maria Artunduaga, the founder and CEO of Samay, a startup that's using acoustic energy to get a clearer picture of the lung's performance. Family tragedy and professional frustration set Dr. Artunduaga on a course that won MedTech Innovator's Grand Prize. She has the giant check to prove it. This episode was sponsored by DeviceTalks Boston. You can register at Boston.DeviceTalks.com. Rachel Robinson, COO of MassMEDIC, joins us on the Newmarker's Newsmakers. Before we hit the news of the week, Robinson gave a preview of the upcoming MassMEDIC's Symposium & Gala on March 6. Go to MassMEDIC.com for more information. MassDevice Executive Editor Chris Newmaker then delivers news on - Boston Scientific, ResMed, Globus Medical, BD and Baxter. Hilarity ensues. Thanks for listening to this episode of the DeviceTalks Weekly Podcast. Subscribe to the DeviceTalks Podcast Network so you don't miss a future episode.

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.

This episode discusses a huge unmet need in the medical device space: treatment for mixed urinary incontinence. Millions of patients, primarily women, suffer from this condition, and there is no effective treatment on the market. Current treatment options leave care gaps and patients resorting to over-the-counter products for symptom management.Juniper Biomedical is a company that is developing a new type of treatment for mixed urinary incontinence. They are developing a unique neuromodulation micro implant that can be implanted with a minimally invasive procedure to deliver a very precise therapy. This has the potential to solve the problems of mixed incontinence, eliminate issues with inaccurate diagnosis, and importantly, provide a solution that patients are more likely to accept.CEO and co-founder, David Constantine joins us to discuss their exciting progress, from extensive preclinical studies, to upcoming clinical trials. After a year of multiple highlights, including award winning on the stage of Medtech Innovator, the future looks bright for Juniper Biomedical. Their technology has the potential to make a real difference in the lives of millions of patients with pelvic health conditions, a story sure to leave you, informed and inspired.

In this episode of the DeviceTalks Weekly Podcast, Host Tom Salemi opens by making a strong case for MedTech people to attend DeviceTalks West, which is happening on Oct. 16-17. Go to West.DeviceTalks.com to register. MassDevice Editor Chris Newmarker brings his Newmarker's Newsmakers – Women's Health, Philiips, Nyxoah, CMR Surgical, and Johnson & Johnson MedTech. Finally, Paul Grand, CEO of MedTech Innovator, introduces DeviceTalks listeners to the five finalists who will compete for the 2024 Early-Stage Grand Prize. The winner will be voted for at the AdvaMed annual meeting in Toronto. Thank you for listening to the DeviceTalks Weekly Podcast Subscribe to the DeviceTalks Podcast Network so you don't miss a future episode.

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.

Deep brain stimulation (DBS) is a neurosurgical procedure that treats neurological conditions by implanting electrodes into the brain to produce electrical impulses. These impulses can control abnormal brain activity and chemical imbalances that cause conditions like Parkinson's disease, essential tremor, and dystonia. Despite the benefits of DBS, less than 1% of the 25 million patients who are eligible to undergo the procedure opt-in due to the invasiveness of and risk associated with traditional open brain surgery. Nicky Driscoll, CTO of NeuroBionics, joins this episode to share how their team is on a mission to change the status quo through bioelectronic medicine. NeuroBionics is developing devices that seamlessly integrate with the human body and aim to offer DBS with a minimally-invasive approach. As well as learning about this exciting technology, Nicky shares insights into the journey from academic researcher to entrepreneur, and how they decided to focus on a challenging commercialization journey that could positively impact patient lives. As one of the top startups in the M2D2 accelerator program and recent winners the 2024 Vision Award with Medtech Innovator, the NeuroBionics story is definitely one to follow, and is sure to leave you informed and inspired.

As a startup venturing into the dynamic landscape of medical technology innovation, the road ahead may seem riddled with obstacles. From fierce competition to ever-evolving regulatory landscapes, the journey to success can be fraught with uncertainty. I'm your host, Kevin Blevins. In the last episode, Jim Gernatt and I were speaking with Paul Grand founder and CEO of Med Tech Innovatory. We left off discussing Paul's background, the remarkable journey of Med Tech Innovator, and its pivotal role in shaping the future of healthcare. Today, we continue this conversation with Paul diving into innovative initiatives driving this transformative organization.  In this part, you will gain insights into the pivotal role of organizations like MedTech Innovator in guiding companies through the complexities of commercialization, including navigating investment challenges and addressing payment and coverage issues. By the end of this episode, you'll have a comprehensive understanding of the MedTech Innovator landscape and actionable advice for making a significant impact in healthcare. What You'll Learn in This Episode: Challenges faced by MedTech startups, including lack of guidance and funding. (04:16) MedTech Innovation ecosystem, including peers, key opinion leaders, investors, strategic partners, and payers. (07:02) The value of working with a partner like Siemens. (14:05) The importance of getting out of echo chambers and seeing different perspectives. (20:20) The importance of fixing investment and payment systems in the medical technology industry. (31:49) Connect with Paul Grand: LinkedIn Website  Connect with Jim Gernatt: LinkedIn Connect with Kevin Blevins: LinkedIn

In this episode, Charles Allan at MY01 and Duane Mancini discuss his background in the Medtech industry, what MY01 is working on, the Medtech Innovator program, focus on collecting clinical data for commercialization support, fundraising strategies as you advance rounds, the Canadian Medtech ecosystem and so much more.

Accelerators provide essential coaching, resources, mentorship, and networking opportunities to startups, enabling them to navigate challenges and scale effectively in the competitive landscape.  I'm your host, Kevin Blevins, and I have a co-host, Jim Gernatt. He leads the Innovation Partnership ecosystem for Siemens, working with incubators and accelerators.   Today, we're speaking with Paul Grand, founder and CEO of MedTech Innovator, one of the foremost MedTech accelerators globally, dedicated to fostering innovation in digital health, medical devices, and diagnostics. In this part one of a two-part episode, you will gain valuable insights into the unique challenges and opportunities faced by startups in the MedTech space. From understanding the funding dynamics and investor sentiments to the genesis of MedTech Innovator as a platform to support and guide healthcare startups, this episode offers a deep dive into the world of medical technology entrepreneurship.  What You'll Learn in This Episode: MedTech industry funding challenges and exit opportunities. (2:28) Entrepreneurship, resilience, and persistence in the MedTech industry. (7:29) The evolution of a venture capitalist in the MedTech industry. (13:17) The challenges faced by MedTech startups in gaining visibility (16:27) MedTech innovation and its impact on healthcare. (21:35) Connect with Paul Grand: LinkedIn Website Connect with Jim Gernatt: LinkedIn Connect with Kevin Blevins: LinkedIn

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.  

Every day, we see technology improving the systems and industries all around us. From finance to environmental science and more, technological advances are allowing us to make great changes to the way we live and work. The medical field is no exception, with scientists and inventors working tirelessly to improve healthcare across the board. Crystal Nyitray, the CEO of Encellin, is here today to talk about how her company is changing the game by introducing cell-based therapies, allowing healthcare to become even more personal. This week's episode 107 of How Women Inspire Podcast is about revolutionizing medicine with cell-based therapies! In this episode of How Women Inspire Podcast, Crystal Nyitray is sharing the importance of disruptive technology to improve our lives and actionable steps you can take right now to get involved with Encellin. Crystal Nyitray is the Founder and CEO of Encellin. She is an alumna of UCSF, Sanofi, and Y Combinator. She led Encellin's over $5M seed raise, authored over 10 patents, and is an awardee of MedTech Innovator, Rosenman Innovators, and American Diabetes Innovator. Some of the talking points Julie and Crystal go over in this episode include:The potential of encapsulated cell replacement therapy to revolutionize medicine.How startups have the luxury of risk and can experiment with emerging technologies to benefit everyone.Embracing inexperience as a strength and building networks from scratch.How being comfortable with being different can lead to disruptive innovation and impactful change.Thank you for listening! If you enjoyed this episode, take a screenshot of the episode to post in your stories and tag me!  And don't forget to follow, rate, and review the podcast and tell me your key takeaways!Learn more about How Women Inspire at https://www.howwomenlead.com/podcast CONNECT WITH CRYSTAL NYITRAY:LinkedInEncellinCONNECT WITH JULIE CASTRO ABRAMS:LinkedIn - JulieHow Women LeadHow Women InvestHow Women GiveInstagram - HWLLinkedIn - HWLFacebook - HWL

Join us in a discussion with Diane Bouis, director of MedTech Innovator, the world's largest life science startup accelerator program.

We'll open this week's episode with Paul Grand, CEO of the MedTech Innovator. Grand issued a last call for medical device entrepreneurs to apply to be part of this year's program. Lots of good stuff come with it. Listen to the episode and apply at MedTechInnovator.org. Then Co-Hosts Tom Salemi and Chris Newmarker interview successful startup CEO Bill Gruber about his new book, The Leadership Blueprint. Gruber shares some experiences and lessons, but entrepreneurs are encouraged to buy the book on Amazon. Finally, Tom Salemi interviews Ahmet Tezel, Company Group Chairman and Global Head of J&J MedTech Innovation and R&D about his path into medtech and what the future holds for Johnson & Johnson and the medical device industry. Thank you to the sponsor of this episode – Tecan. Here's a message - Tecan brings all the healthcare OEM pieces together with fully integrated solutions across the entire MedTech and life sciences spectrum from idea to implementation. Partner with us to revolutionize the way you develop medical technology with the Emphysys approach and turn your visionary ideas into a tangible reality in a matter of months, not years. www.emphysys.com/ Thank you for listening to the DeviceTalks Podcast Network. Subscribe now to the DeviceTalks Podcast Network.

Paul Grand is the founder and CEO; Ayelet Marom is the Program Director for BioTools Innovator, which focuses specifically on biotools; and Jim West is the Associate Director, BioTools Innovator, who was previously the Co-Founder and CEO of, Clara Biotech, which was founded in 2018 and was acquired by Innovaprep in the summer of 2023. Jim was the first founder to go through the biotools program. In this episode of lab to startup, we first discuss some of the challenges that affect medtech and biotool technology startups, and then go into ways that medtech innovator, an accelerator program is helping founders in this space, especially around lessons learned and how the program has evolved into one of the best accelerators in this space. https://medtechinnovator.org/about-us/ Founding story of Medtech Innovator Things medtech startups struggle with: Articulating value proposition; understanding reimbursement; having the wrong CEO; staying in stealth mode; choosing the wrong indication Medtech innovator “Value program” Value coaches from established companies like J&J How startups get accepted to the program No equity, no fees and no strings attached for being a part of the program Bringing the right investors to the table to support founders Biotools innovator program: https://biotoolsinnovator.org/ Challenges in the biotools space How investors are different in this space Pay for Service as a model Story of Jim West, Founder and CEO of Clara biotech, that went through the program Advice on slide decks Info session videos: https://www.youtube.com/@Medtechinnovatorchannel

In this episode of The Brand Called You, let's dive into the world of MedTech innovation as Dr. Aditya shares insights into her journey from being a scientist to a MedTech entrepreneur. Discover the challenges faced and overcome, the impact of mentorship, and the groundbreaking projects focusing on women's health. Learn about Novo Connect, Dr. Aditya's entrepreneurial platform supporting women in STEM, and her vision for cross-border collaborations in the ever-evolving field of medical technology. [00:43] - About Dr. Sangeeta Aditya  Sangeeta is the president of GWASE.  She's the owner of Novo Connect and Novo Analytics.  She is a MedTech Innovator, a mentor and an entrepreneur.  Sangeeta is building an entrepreneurial platform for women in STEM. And she's a mentor of change at the Niti Aayog. --- Support this podcast: https://podcasters.spotify.com/pod/show/tbcy/support

Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here's what you need to know for today, October 12, 2023. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. Novo Nordisk has announced that it acquired all shares of drug delivery device maker Biocorp. Fast Five host Danielle Kirsh and guest cohost Jim Hammerand discuss the deal, including when the acquisition talks began. Ambu named its new chief financial officer for 2024. Find out who is taking over and what some of their career history is that supports this appointment.  The FDA has approved a next-gen intrathecal drug delivery system from Medtronic. Kirsh and Hammerand talk about the technology and what sets it apart from previous iterations of the device.  Medtech Innovator announced the 2023 Grand Prize winner at AdvaMed's Medtech Conference in Anaheim. Hear who the winner is and what their technology does in today's episode.  Boston Scientific won an expanded indication for its spinal cord stimulation system. The Fast Five hosts talk about the technology, some of the features and the optimism that executives have after this approve. Bonus: Sean Whooley brings his insights from the AdvaMed Medtech Conference. His biggest takeaway from Day 2 is about building innovative business models and disruptive technologies, as well as what big companies are thinking about mergers and acquisitions. Tune in to hear what he had to say and check out the rest of his coverage on MassDevice here.

This week's episode is dedicated entirely to the 10 Finalists of MedTech Innovator's Pitch Competitions. The final winners will be selected by the audience on Oct. 10 at the upcoming AdvaMed annual meeting. The finalists for MedTech Innovator's grand prize of $350,000 are listed below. Click on the link to watch their 1-minute pitch video. Dr. Tom McClellan - Fingy3D - https://www.youtube.com/watch?v=KCoj_ZALf3c Amanda French - IFPx - https://www.youtube.com/watch?v=8B3j2weOkNo Jay Shah/Vivek Ganesh - Neurava - https://www.youtube.com/watch?v=lyUB9WCLeww Dr. Alex Woods - Newrotex - https://www.youtube.com/watch?v=MEhP_Ack32c Alex Ballatori/Shane Shahrestani - StrokeDx - https://www.youtube.com/watch?v=tdkl5QyDfD8 The companies listed below are vying for MedTech Innovator's Execution Award. The winner will receive $25,000. Click on the link to watch their 1-minute pitch video. Harlee Sorkin - InterShunt Technologies - https://www.youtube.com/watch?v=QPi5FSRSjUQ Michael Ebner - Hypervision Surgical - https://www.youtube.com/watch?v=oTz-AXfwJgw Lori Arakaki - Opticyte - https://www.youtube.com/watch?v=AECmlLpv0hE Joanna Nathan - Prana Thoracic - https://www.youtube.com/watch?v=myjUp3Gg4mQ Dushyanth Surakanti - Sparta Biomedical - https://www.youtube.com/watch?v=wvS9PwpkT_c DeviceTalks's Tom Salemi and Kayleen Brown visited with the founders and CEOs of each of the 10 companies. We'll run through those interviews with Paul Grand, CEO of the MedTech Innovator program. Thanks for listening to the DeviceTalks Weekly Podcast Subscribe to the DeviceTalks Podcast Network on any major podcast application.

Join us on a compelling episode of BioTalk as we sit down with three dynamic leaders from groundbreaking MedTech companies based in the thriving BioHealth Capital Region. These companies, JuneBrain, Xcision Medical Systems, and Sonavi Labs, were recently selected for the prestigious MedTech Innovator Accelerator, the world's largest accelerator of medical technology companies. Discover their innovative solutions and the transformative impact they are making in healthcare. In this episode, we delve into the cutting-edge advancements and game-changing technologies developed by our esteemed guests. Dr. Samantha Scott, Founder, and CEO of JuneBrain, shares insights on how their remote diagnostic tools utilizing retinal image data are revolutionizing disease progression evaluation, particularly in underserved communities. Ellington West, Co-Founder and CEO of Sonavi Labs, discusses the power of AI in respiratory disease detection and management and its future implications in transforming diagnostics. Michelle Crawley, President of Xcision Medical Systems, sheds light on the GammaPod system and how it disrupts the traditional breast cancer treatment model by delivering higher doses of radiation. Our conversation also explores the significance of being part of the MedTech Innovator Accelerator, the opportunities it offers, and how it helps these companies connect with leading manufacturers, providers, and investors in the industry. We delve into the rigorous application and selection process that set these companies apart from over 1,150 applicants, highlighting their unique contributions to the field of MedTech. We discuss the invaluable role of the BioHealth Capital Region in nurturing and propelling these companies forward. Discover how the region's ecosystem, resources, and talent have facilitated their growth, allowing them to impact patient care and medical advancements. Join us for this captivating episode as we explore the future of MedTech innovation, the power of AI, and the transformative potential of cutting-edge technologies in the BioHealth Capital Region.

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.

Last call for DeviceTalks Boston! In this episode we'll preview our upcoming conference by talking with Paul Grand, CEO of Medtech Innovator, Rebecca Whitney, SVP at ZimView, Holly Scott and Joe Mullings at the Mullings Group. We'll have Fastball Pitches from two Medtech Innovator companies that will be presenting on May 10-11. Register at DeviceTalks.com. Use the code DTWeekly25 to save 25% Chris Newmarker delivers his #newmarkernewsmakers featuring 3M, Zimmer Biomet, Stryker, Medtronic and Casana, maker of a now FDA-approved smart toilet seat. Thanks for listening to the DeviceTalks Weekly Podcast. Subscribe to the DeviceTalks Podcast Player on any major podcast application.

In this episode, Tom Salemi interviews Mark Dickinson, worldwide president at Cerenovus, the neurovascular business at Johnson & Johnson Medtech. Mark Dickinson shares his unique entry into the medical device industry, how he built his career at the global company, and what the company is doing to develop its devices to treat stroke patients. In addition, we'll also have interviews with Paul Grand, CEO of Medtech Innovator, and Jeff Alvarez, chief strategy officer at Moon Surgical. Both will be speaking at DeviceTalks Boston on May 10-11. Go to DeviceTalks.com to register. This episode is sponsored by the Medical Business Unit at TE Connectivity. For more information go to TE.Com/medical. Thanks for listening to this episode of the DeviceTalks Weekly Podcast. You can subscribe to the DeviceTalks Podcast Network on any major podcast application.

Angel Scale Biotech: Learn More   Finding a less noxious way to sterilize medical devices is the goal of CL Tian, winner as MedTech Innovator '22. She founded Phiex to commercialize a sterilant that allows devices to sterilize themselves in the presence of light. Industry is listening to this compelling founder.   Sponsored by Purdue University entrepreneurship and Peter Fasse, patent attorney at Fish and Richardson.   Highlights: Sal Daher Introduces CL Tian What Problem Phiex is Solving "... The moat is how do you deliver it without using capital equipment, with plastic packaging material as the delivery system, and how do you deliver it when it's activated by light? Our materials, once they see ambient light, start to release a sterilant..." “... I don't think I mentioned, but the amount of devices that are sterilized with this cancer-causing technology's half of the industry. That's 20 billion devices in the US a year. There's no alternative for most of those devices…” CL Tian's Background How CL Tian Came to the Issue of Sterilization Message to the Audience Topics: biotech, discovering entrepreneurship, founding story, product

In this episode, Celine Martin, company group chairman, Cardiovascular & Specialty Solutions Group, offers insights from her career at Johnson & Johnson. What are the four variables you need to consider to thrive in a global company. Martin also shares insights on cardiac ablation, neurovascular, and where the company is headed following the acquisition of Abiomed. Paul Grand, CEO of Medtech Innovator, joins as a co-host offering insights on Chris Newmarker's Newsmakers – Moon Surgical, Butterfly Network, Medtronic, Avail Medsystems, Dexcom, and Fresenius Medical. Grand shares a personal connection to one of the companies. Grand, Newmarker and Tom Salemi also share their thoughts on the retirement of Mike Mussallem, CEO of Edwards Lifesciences. Thank you to Nordson Medical for sponsoring this episode. Go to NordsonMedical.com for more information. Thank you for listening to the DeviceTalks Weekly Podcast You can subscribe to this podcast on any major podcast player.

Guest: Edmund Wessels is a PhD candidate at UCT MedTech and the cofounder of VAS MedTech. He joins Zain to celebrate his position on the shortlist for the Africa Prize for Engineering Innovation.See omnystudio.com/listener for privacy information.

In this week's episode, we'll visit with CL Tian, co-founder and CEO of Phiex Technologies, Medtech Innovator's 2022 Grand Prize winner chosen by attendees at this week's AdvaMed conference in Boston. Tian details the pending problems facing the medtech industry due to concerns about current sterilization practices and shares how Phiex could help alleviate the problem. At the start of the episode, co-hosts Tom Salemi and Chris Newmarker are joined by Associated Editor Sean Whooley and Pharma Editor Brian Buntz to revisit the high points of last week's DeviceTalks West conference in Santa Clara. Thanks to all of our speakers, sponsors and attendees! To read the report mentioned in the podcast go here. https://www.bcg.com/publications/2022/us-ahead-in-medtech-regulation You can find ongoing coverage at MassDevice. Thanks for listening to the DeviceTalks Weekly Podcast. Subscribe to this podcast on every major podcast player.

Just a short visit today. Paul Grand of the Medtech Innovator introduces us the five finalists of his start-up program. They'll compete for the top spot at AdvaMed's meeting next week. in Boston. Remember to join us at DeviceTalks West THIS week. Register at DeviceTalks.com.

In this week's episode, host Mike Moore talks to Anna Lisa Somera, CEO of Rhaeos, and the 1st female winner of MedTech Innovator, the largest medical device competition in the world. With the effect of the COVID-19 pandemic in the medical industry, Rhaeos has responded to the big transition of the care setting with their wireless wearable device, FlowSense – a non-invasive thermal sensor that is set to solve a really big problem in Hydrocephalus management. Today, Mike and Anna Lisa discuss how Rhaeos started out, how FlowSense works and how it addresses the need for Hydrocephalus management. Notable Quotes “I had the fortune of meeting a mom of a hydrocephalus patient and she told me how she couldn't work anymore, how her daughter missed so many days of school, how there've been countless times that she's been to the ER, and how her life is hard. But she, as a mom, and her primary caregiver works hard day and night so that her daughter has a normal life as possible. And as she was telling me her story, I had to think of happy thoughts because I'm a mom of two and I'm like, Anna Lisa, don't cry, just keep it together. I wasn't prepared for that. I can read about it, but then when someone is in front of you telling you how hard their life is and then how what you're working on can help them, that's like a different feeling.” - Anna Lisa (15:27) In This Episode (01:39) How Rhaeos started (06:27) Anna Lisa as Rhaeos' employee number one (08:21) What makes FlowSense unique and how does it work? (15:18) The moment Anna Lisa realized that Rhaeos was the company for her (17:30) What engineers do in the lab is making a difference and changing lives (20:26) The challenges that Rhaeos faced (24:05) Rhaeos' experience with the FDA (25:55) The lack of funding on the academic side for hydrocephalus (33:20) The biggest challenge that Rhaeos will face from a commercial perspective Our Guest Anna Lisa Somera is the Co-founder and Chief Executive Officer of Rhaeos, Inc. She is an entrepreneur with deep experience in startups, venture capital, technology transfer, biomedical research, and life science consulting. She specializes in early-stage, cutting edge technology businesses and has been a part of the entrepreneurial community for 18 years. Resources & Links Mike Moore https://www.linkedin.com/in/michaeljeffreymoore/ https://www.linkedin.com/company/thebleedingedgeofdigitalhealth/ The Bleeding Edge of Digital Health Apple Podcasts Google Amazon Spotify YouTube Anna Lisa Somera  https://www.linkedin.com/in/anna-lisa-somera-5058482/ https://www.linkedin.com/company/rhaeos/ https://www.rhaeos.com/

We're continuing our season topic: The F Word (Fundraising) On today's episode, we welcome back host Isabella Schmitt as she speaks with Paul Grand, CEO of MedTech Innovator, one of the largest accelerator of medical technology companies in the world. Finding and selecting the right investors for your business, product, or idea can be a stressful and grueling process. There is so much vetting to do on both sides on the street that it can make it hard to focus on the big picture. Hmm... this almost sounds a little like dating. Today's episode: The Investor Dating Game.    

Radiation oncologist Dr. James Mitchell joins the BackTable Innovation podcast to discuss the development and acquisition of his medical devices; first, an integrated needle/guidewire system called Redsmith, and then a smart vascular access port called Oncodisc. --- EARN CME Reflect on how this Podcast applies to your day-to-day and earn AMA PRA Category 1 CMEs: https://earnc.me/XfXBqO --- SHOW NOTES In this episode, physician-entrepreneur and radiation oncologist Dr. James Mitchell joins our host Dr. Bryan Hartley to discuss the development and acquisition of his medical devices– first, an integrated needle/guidewire system called Redsmith, and then a smart vascular access port called Oncodisc. Dr. Mitchell first explains how he met his co-founder, interventional radiologist Andy Thoreson, while they were both practicing medicine at the Keesler Air Force base. They connected due to common interests in business and investing. Eventually, they began to discuss clinical needs that they saw in their everyday lives and potential devices to address them. To protect their medical device ideas, they filed IPs and addressed patents to a company, rather than themselves as individuals. Dr. Mitchell emphasizes that this method is highly favorable when there are multiple inventors of a device, since assigning the patent to a separate entity will prevent legal issues and de-risk the business for future acquirers. When forming a new company, Dr. Mitchell believes that good corporate governance is key. This involves asking fundamental questions about the business goals, location of incorporation, type of corporation, and fundraising strategies. Eventually, Drs. Mitchell and Thoreson launched Redsmith, which was purchased by BD. Due to external factors, the purchase took two years. Next, the co-founders embarked on a mission to develop Oncodisc, a port that would automatically notify doctors when cancer patients' physiological signs indicated high risk for sepsis. Dr. Mitchell described a new mindset for this second product– He wanted to build a business out of this technology instead of selling it to a larger company. Taking a product through commercialization would allow him to have more influence over the final product and result in a larger impact on the healthcare system. Additionally, he wanted to explore applications of Oncodisc beyond cancer care, since ports are utilized in many chronic conditions such as end-stage renal disease and congestive heart failure. What started as a simple addition to chemotherapy ports became a larger digital health mission. Finally, Dr. Mitchell discusses the mechanics of his fundraising process. The seed round mainly included friends and colleagues who were clinicians, since they recognized the utility of Oncodisc. Having this network of investors also allowed the co-founders to obtain clinical advice during R&D. The subsequent Series A round presented different challenges, since Dr. Mitchell was presenting to investors from highly specialized business backgrounds, and little clinical expertise. He had to learn how to address extensive questions over regulatory strategy and effectively communicate his clinical ideas during his pitches. Dr. Mitchell ends the episode by advising entrepreneurs to expand their networks to include people of all different professions and valuable, diverse insights. --- RESOURCES PAVmed: http://www.pavmed.com/ Biomerics: https://biomerics.com/ BD: https://www.bd.com/en-us HealthTech Capital: https://healthtechcapital.com/ Society of Physician Entrepreneurs: https://sopenet.org/ Innovator MD: https://www.innovatormd.com/ UCSF Rosenman Institute: https://rosenmaninstitute.org/ MedTech Innovator: https://medtechinnovator.org/

DeviceTalks Boston is here! Win a free registration. In this week's episode, we'll give you a little taste of what you'll see at the Boston Convention & Exhibition Center on May 10-11. Friend and colleague Steve Crowe, editorial director of the Healthcare Robotics Engineering Forum, will share what attendees will see at that meeting, which is co-located with DeviceTalks Boston. Then, we'll talk with Peter Stebbins about his Opening Keynote Interview with medtech veteran Peter Doyle, who is now dean of Harvard John A. Paulson School of Engineering and Applied Sciences. We'll also get a final update from Paul Grand, CEO of Medtech Innovator, about the 22 mid-stage medical device companies that will be presenting at DeviceTalks Boston. A selected few will then compete at Medtech Innovator's Pitch Contest on May 11. And to demonstrate we're not just selling you on an event, we talk with Dave Evans, co-founder and CEO of Fictiv, a technology company that has raised nearly $200 million to fix – or disrupt – the supply chain. Finally, a contest for loyal and attentive DeviceTalks Weekly Podcast listeners. Win free registration to DeviceTalks Boston!

In this week's podcast, we'll speak with Sally Saba, MD, Medtronic's chief inclusion and diversity officer, about the company's work to create a more welcoming – and better performing – workplace. Paul Grand, CEO of MedTech Innovator, returns to take part in Executive Editor's Chris Newmarker's Newsmaker session. We talk about hour industry's response to Russia's invasion of Ukraine, Ryan Egeland, MD, joining Big Sky Innovator, the top-performing companies of 2021, the collapse of another SPAC deal, and an eye-opening approval. https://www.medicaldesignandoutsourcing.com/how-medtech-and-pharma-are-responding-to-russias-invasion-of-ukraine/ https://www.massdevice.com/former-cardiovascular-systems-chief-medical-officer-joins-big-sky-biomedical-incubator/ https://www.massdevice.com/these-10-medtech-companies-stocks-performed-best-in-2021/ https://www.massdevice.com/memic-innovative-surgerys-spac-deal-is-off/ https://www.massdevice.com/alcon-launches-clareon-intraocular-lens-in-u-s/ BUY A MAMMOTH TOOTH FOR A GOOD CAUSE - https://www.newburyportnews.com/news/mammoth-find-for-gigantic-ukrainian-cause/article_bed30a28-a093-11ec-a3a2-370b99bd241b.html LEARN ABOUT DEVICETALKS BOSTON https://gateway.on24.com/wcc/eh/2927718/lp/3691568/were-back-an-insiders-look-into-bringing-back-a-better-devicetalks-boston SIGN UP to try to present at DeviceTalks Boston though the MedTech Innovator Program https://medtechinnovator.org/apply/

In this episode, Giovanni Lauricella and Peter Vranes discuss his background as an entrepreneur, how they founded Nutromics, what the company is doing, where does Australia fit in the global MedTech industry, the advantageous clinical trial environment in Australia, their experience raising capital and closing their most recent round, the lack of investors and how that affects startups in Australia, their experience with Medtech Innovator, why Peter always takes investor meetings, and so much more. Peter Vranes LinkedIn Nutromics Website Giovanni Lauricella LinkedIn Project Medtech LinkedIn Project Medtech Website

In this episode, Giovanni Lauricella and Peter Vranes discuss his background as an entrepreneur, how they founded Nutromics, what the company is doing, where does Australia fit in the global MedTech industry, the advantageous clinical trial environment in Australia, their experience raising capital and closing their most recent round, the lack of investors and how that affects startups in Australia, their experience with Medtech Innovator, why Peter always takes investor meetings, and so much more. Peter Vranes LinkedIn Nutromics Website Giovanni Lauricella LinkedIn Project Medtech LinkedIn Project Medtech Website

We drill down on diagnostics – including COVID-19 testing – with Dave Hickey, newly promoted executive vice president and president of the life sciences segment of BD and Brooke Story, who took over his post as worldwide president of integrated diagnostic solutions. How did BD handle the crushing demand for at-home tests and where is diagnostics headed in the future. Paul Grand, CEO of Medtech Innovator, sits in with Chris Newmarker and Tom Salemi on this week's Newmarker's Newsmakers. He also delivers some important deadlines for medical device startups. This week's Newsmakers include Medtronic, Edwards Lifesciences, Distal Motion, Respironics and ZimVie. Find out more about Medtech Innovator at MedtechInnovator.org. Register for DeviceTalks at devicetalks.com. Use the discount code mentioned in this episode! Subscribe to this podcast on any major podcast channel.

Welcome to Season 3 episode 2 of the KnowStroke Podcast.In this episode we sat down for a stimulating conversation with Sandra Saldana, CEO and co-founder at Alva Health. Sandra launched  Alva Health as a spin out from Yale University entrepreneur fellowship program in 2017. Alva Health's mission is to develop, commercialize, and make accessible a first-in-class medical device that accurately detects strokes using patient-worn wearables. 2021 was a milestone year for Alva Health as they were selected as the winners of the Medtech Innovator accelerator program - the industry's global competition and accelerator for early and mid-stage medical device, diagnostic, and digital health companies. The device is shown below and looks like a livestrong band which is meant to be worn 24/7 - currently it detects hemiparesis which is a common biomarker of stroke. The more a user wears the device, the more it learns about the movement of that specific user. For any irregularities the device will alert the patient and notify 911. In the future they will be iterating on the product to incorporate speech and facial recognition technology.Born in Monterrey, Mexico, she moved to the US at 12 years old and grew up in Houston, Texas. Sandra's father ran a successful business so from a young age she remembers having the itch to start her own company one day. She began her studies at Cornell University in upstate New York and then moved back to Houston to study a PhD in Cancer Biology. After a few years in academia Sandra made the move into industry and had her first taste of the med-device / pharma industry while running sales for a start-up in Boston.After a few years of the C-Suite she was eager to start her own company. Not long after being accepted to Yale's MBA in healthcare program she met her co-founders and being validating a concept for a wearable to detect stroke. It was a long journey, one that she explains in detail in this episode and speaks to the hurdles along the way.Sandra has a true understand of what is wrong with the current stroke care pathway, this will become evident when you hear her answer to our Magic Wand question. Alva Health will be launching clinical trials in the second half of 2022. We encourage you to reach out and get involved!  See links below if you'd like to learn more and get in contact with Sandra or the team. Alva Health - https://www.alva-health.com Reach out to Alva Health - https://www.alva-health.com/cover-page-1Twitter - https://twitter.com/alvahealthLinkedIn - https://www.linkedin.com/company/alvahealth/Watch the YouTube Videocast with Sandra here : https://youtu.be/s49Pvj9Nd2YEpisode 3 is going to be a special one as we welcome back our good friend and stroke THRIVER Caroline Goggin alongside her husband Travis.We also wouldn't be able to get these episodes churned out so quickly without our great podcast producer Jake Dansereau. Thank you Jake!Music Credit and Podcast Production by Jake Dansereau, connect at JAKEEZo on Soundcloud  @user-257386777Please connect with us on social.  We appreciate your comments.  We are here to help you!Connect with Team EnableUs and the Know Stroke Podcast Hosts:https://www.enable4us.comhttps://twitter.com/Enable__Ushttps://www.instagram.com/enable.us/For more information about joining our show or advertising with us visit: https://enable4us.comSupport the show (https://paypal.me/SmartMovesPT)

Paul Grand is the CEO of Medtech Innovator which is an accelerator for startups in the medical technology space. It has been going for many years and the companies that they select to go through the 4 month process have gone on to be very successful. Apply for this year's cohort, deadline January 31st https://medtechinnovator.org/apply/  Top 3 Takeaways: "MedTech innovator as an accelerator is the world's largest accelerator for medical technology" "1,800 companies applied last year across all of our cohorts.  We accept around 4% of that." "Some of the benchmarks we've got: over 90 products in the market, $3.5 billion in follow on funding to our companies post-MedTech innovator, and we've had 21 acquisitions." 0:45 "Do you want to introduce yourself?" 3:00 "What is MedTech innovator for? Who is it for?" 6:00 "Is there exclusion criteria or is there some kind of a framework where certain companies would be better fits?" 9:30 Are there companies that would be too big for you? 10:30 "How do you find these companies?" 12:30 "How do you help find investment and how do you help people guide through this process?" 16:45 "What are some of your favorite success stories?" 22:15 Do busy CEOs have to drop everything in order to attend the 4 month workshop? 24:00 "What advice do you have for companies who want to get into Medtech Innovator?" 31:00 "Is there anything that we didn't mention that you wanted to talk about?"  

In this episode we'll explore potentially life-saving treatments for hypertension and stroke. First, we'll talk with Sandra Saldana, CEO of the start-up Alva Health, which is developing a wearable system that can detect strokes. Alva Health won the 2021 Global Competition of the Medtech Innovator program. Then we'll explore renal denervation, the exciting but vexing method of lowering hypertension by ablating nerves in the kidney. We'll talk to the leaders in this space including Andy Weiss, CEO of Recor Medical, a division of Otsuka Holdings, that's developing the Paradise Renal Denervation system. Weiss, a medtech veteran, shares his long-term views, one why he still sees Renal Denervation as a game-changer. Then, we'll run an excerpt of the MedtronicTalks podcast interview with Jason Weidman, senior vice president and president of the coronary and renal denervation business at Medtronic. Weidman details Medtronic's latest regulatory hiccups but, like Weiss, explains why he sees renal denervation as an important new therapy that can save the lives of people struggling to control their hypertension. You can listen to the entire interview with Weidman here. https://www.devicetalks.com/weidman-talks-us-through-the-long-road-to-get-symplicity-ready-to-help-patients-with-hypertension/.

Gregory Montalbano speaks with Paul Grand who is the Founder and CEO of MedTech Innovator. Paul runs MedTech Innovator as a stand-alone non-profit which is also the largest accelerator of medical technology in the world. Together, Greg and Paul discuss the methods of mentoring and support offered to the entrepreneurial groups spanning medical device, digital health, and diagnostic applications. Paul will also outline the various MedTech Innovator industry as well as venture partner networks that support their members. Greg and Paul's discussions will also include what MedTech Innovator looks for in a startup and how they can apply to the MedTech Innovator programs. Lastly, this podcast will also cover new MedTech innovative initiatives and exciting breakthroughs that are expected on the horizon from the MedTech Innovator member network.

In this episode of Outcomes Rocket MedTech, we are excited to host Mike Ricci, CEO at Spect. Mike discusses how Spect offers screening for eye diseases, so patients can receive early diagnosis and treatment. He shares the company's genesis, value proposition, and the three key metrics which fit Spects in the workflow. He also talks of the business model and his long-term vision for the company. Spect is a multi-awarded startup data science company. It is a finalist in MedTech Innovator 2018. Spect has officially capped its seed fund, hired people for key positions, and is already getting a lot of commercial traction. Whether you are somebody who wants to work at a startup or an investor, this is a great opportunity, so make sure to tune in! Click this link to the show notes, transcript, and resources: outcomesrocket.health

In this episode of Outcomes Rocket MedTech, we have the privilege of hosting Andy Doraiswamy, founder and CEO of Koya Medical and a finalist in Medtech Innovator in 2019. Koya is a transformative healthcare company developing breakthrough treatments for lymphedema and venous diseases to increase movement mobility and personalized care that is unavailable with traditional compression therapy. Andy discusses how his company's reimagined treatment delivers improved quality of life for patients with movement and mobility problems. He talks about Dayspring's advantage over existing solutions, the recent 501k clearance from the FDA, and the new CMS code. He shares his thoughts on some important things an innovator needs like having the right backers, having a fantastic team who understands your mission, and being transparent with them. Get your notes ready because there's plenty of things to learn from this interview with Andy. Please tune in! Click this link to the show notes, transcript, and resources: outcomesrocket.health

In this episode, Giovanni and Paul discuss Medtech Innovator, how they add value to a start-up company, common errors he used to see in start-up companies, the mechanics of how Medtech Innovator works, how they prepare their companies for external capital and more. Paul Grand LinkedIn Medtech Innovator Website Giovanni Lauricella LinkedIn Project Medtech LinkedIn Project Medtech Website

In this episode, Giovanni and Paul discuss Medtech Innovator, how they add value to a start-up company, common errors he used to see in start-up companies, the mechanics of how Medtech Innovator works, how they prepare their companies for external capital and more. Paul Grand LinkedIn Medtech Innovator Website Giovanni Lauricella LinkedIn Project Medtech LinkedIn Project Medtech Website

In this episode of the Outcomes Rocket MedTech, we are excited to feature Kate Dilligan, the founder and CEO at Cooler Heads and one of the five finalists in the MedTech Innovator 2021 competition. Kate shares the story behind Cooler Heads and how her experience as a cancer patient pushed her to find ways to eliminate chemotherapy-induced hair loss more affordably. She discusses the value prop of her product and the difference over the existing standard of care. Kate also talks about setbacks and insights, and she strongly emphasized the importance of working with the FDA. There are so many things to learn from this insight-packed interview with Kate so please tune in! Click this link to the show notes, transcript, and resources: outcomesrocket.health

In this week's episode we are joined by Alex Alguire Senior Manager in Strategic Marketing at Intellijoint Surgical, a Canadian orthopedics start-up. This episode materializes the article the "Engineer: Sales? I didn't know that was an option" that Alex contributed to our Medtech Innovator blog by Medtalkcracy. We explore his choice to forego a Masters degree and dive right into Sales with no business background, the skills you can pickup during school for sales roles, how to sell medical devices and the future of Canadian MedTech. Alex's Article: https://medtalkcracypod.medium.com/engineer-sales-i-didnt-know-that-was-an-option-36e06cb1753 Alex's LinkedIn: https://www.linkedin.com/in/alex-alguire-38298766/ Co-Founders: Alia Myers - https://www.linkedin.com/in/aliamyers/ Zion Maynard - https://www.linkedin.com/in/zionmaynard/