Podcasts about Medtech

In this episode of Let's ComBinate, Subhi Saadeh sits down with Jeff Gensler, a quality and regulatory leader with 30+ years in MedTech, pharma, and combination products.Jeff takes us inside FDA warning letters, consent decrees, and massive remediation efforts—including the 1,400 DHF Zimmer Biomet project and achieving 99.999% reliability with the EpiPen. He shares the CAPA playbook he's refined over decades, the high-stakes negotiations with FDA, and the critical role of containment, third-party reviews, and inspection readiness.The conversation shifts to Quality 4.0 how electronic batch records (EBRs), AI, and digital systems can move quality from reactive to preventive. Jeff also introduces his new Quality 4.0 Consortium, designed to bring proven digital solutions to small and mid-sized pharma companies.Timestamps:00:00 – Introduction & Guest Welcome00:42 – Facing a Warning Letter: The Zimmer Experience02:05 – Remediation Strategies & Challenges06:03 – Orthopedic Industry Insights09:58 – Transition to Pfizer & Meridian12:54 – Navigating FDA Negotiations16:18 – Balancing Risk & FDA Visibility16:55 – Implementing Quality Systems & Processes18:15 – Leveraging Third-Party Reviews & Audits20:26 – Inspection Readiness & CAPA Processes25:08 – Mergers, Acquisitions & Facility Upgrades27:32 – Digital Transformation in Quality Management31:12 – The Future of Quality Systems & AI Integration33:01 – Benefits of Electronic Batch Records34:13 – Conclusion & Contact InfoJeff Gensler is a veteran quality and regulatory executive with more than 30 years of leadership experience in MedTech, pharmaceuticals, and combination products. Over his career, Jeff has navigated some of the industry's most complex compliance challenges, including FDA warning letters, consent decrees, and large-scale quality system remediations. He has held senior leadership roles at Zimmer Biomet, where he oversaw the remediation of 1,400 design history files involving $300M in resources and 1,500 contractors, and at Pfizer's Meridian Medical Technologies, where his team achieved 99.999% reliability for the EpiPen through advanced quality processes and close FDA engagement. Jeff later served as Vice President of Quality at Kindeva Drug Delivery, where he helped lead a state-of-the-art facility buildout recognized by ISPE as a Facility of the Year finalist. A recognized advocate for modernizing quality systems, Jeff has championed Quality 4.0, integrating electronic batch records, AI, and advanced analytics to shift organizations from reactive to preventive quality management. Most recently, he founded the Quality 4.0 Consortium, a collaborative platform bringing proven digital solutions to small and mid-sized pharma companies.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode, Duane Mancini welcomes to the show Aaron DeGagne, Healthcare Senior Analyst at PitchBook. From quarterly reports to market dynamics, Aaron sheds light on significant healthcare investments, including the rise in surgical tools, devices, and the blurring lines between healthtech and medtech. They delve into the impact of global market uncertainties, interest rates, and the noteworthy deals like Neuralink's $600 million raise. The conversation also explores themes like consumer health advancements, cancer diagnostics, and the potential shifts in IPO activities.Aaron DeGagne LinkedInPitchBook WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedIn

On this episode of The Medical Alley Podcast, we're diving into the rapidly evolving world of contract manufacturing with Jesse Jensen, VP of Operations at Switchback Medical. Switchback Medical is pushing the boundaries of innovation and growth in medtech. From trends in vertical integration and process innovation to global expansion strategies, including a recent expansion into Costa Rica, the company is navigating some of the most dynamic shifts in the industry. Send us a message! Follow Medical Alley on social media on LinkedIn, Facebook, X and Instagram.

Was tun, wenn das rohstoffarme Deutschland im globalen Ranking als Arbeits- und Lebensstandort dramatisch abrutscht – und gleichzeitig 20 Millionen Babyboomer kurz vor der Rente stehen? Gülsah Wilke kennt beide Seiten: Als Co-Founderin des Tech-Netzwerks Two Hearts und Partnerin beim Growth-Fonds DN Capital weiß sie, wie hart der „War for Talent“ mittlerweile wirklich ist – und warum Deutschland ihn gerade verliert.Im Gespräch mit Carsten Puschmann zeigt Gülsah, wie positive Vorbilder und „Safe Spaces“ für internationale Gründer:innen eine völlig neue Willkommenskultur schaffen können, warum amtliches Englisch und radikal digitale Visa-Prozesse längst überfällig sind und wieso wir dringend Milliarden aus Pensionskassen in heimische Wachstumsrunden lotsen müssen.Außerdem verrät sie:Drei Quick Wins, mit denen sich Deutschlands Bürokratie sofort entschlacken ließe – vom FDA-inspirierten Fast-Track für Med-Tech bis zu estnischen e-Government-Standards.Welche Rolle Diversität ≠ Nice-to-have, sondern echter Innovations-Turbo spielt.Weshalb ein attraktiver Kapitalmarkt das einzige Gegenmittel ist, damit künftige Biontechs nicht in New York statt Frankfurt an die Börse gehen.Hört rein, wenn ihr wissen wollt, welche Stellschrauben Deutschland jetzt drehen muss, um wieder ganz oben mitzuspielen – und was jede:r Einzelne heute schon beitragen kann. Hosted on Acast. See acast.com/privacy for more information.

Have you ever wondered what it's really like to work as a medical device consultant or ISO 13485 auditor? In this episode of the Medical Device Made Easy Podcast, I sit down with Adam Isaac, an industry expert who made the leap from engineering student to successful entrepreneur in the MedTech world. Adam's journey is a masterclass in career transformation. Without prior experience in Regulatory Affairs & Quality Assurance (RAQA), he navigated the complex world of compliance and built a thriving consultancy business — all without traditional advertising. What you'll discover in this episode:

Dhruv Agrawal is CEO and president of Aether Biomedical. Discover Dhruv's unique journey from studying medicine in New Delhi to creating life-changing bionic limbs. Under his leadership, Aether Biomedical has achieved significant milestones, including CE certification and FDA registration for its Zeus V1 bionic limb. Dhruv shares his personal story of transitioning from medical school to MedTech innovation, the obstacles faced and lessons learned as a young entrepreneur, and the hope and inspiration of seeing Aether's prosthetics transform lives, especially in war-torn regions.   Guest links: https://www.aetherbiomedical.com | https://www.linkedin.com/company/aether-biomedical | https://www.instagram.com/aether_biomedical/  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 & Editor: Lindsey Dinneen Producer: Velentium Medical   EPISODE TRANSCRIPT Episode 061 - Dhruv Agrawal Dhruv Agrawal [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I'm excited to introduce you to my guest, Dhruv Agrawal. Dhruv is the CEO and president of the management board of Aither Biomedical. He studied medicine in New Delhi before dropping out to pursue a bachelor's in business management. He also has a postgraduate diploma in Medical Device Development Regulatory Affairs from University of California Irvine, and a Master's in Data Science from the University of London. Under his leadership, Aither Biomedical has achieved CE certification and FDA registration for the Zeus V1 bionic limb, and established distribution across nine European countries, the US, and India. Additionally, Aither has raised over 12.5 million US dollars in private capital from leading VCs and has been a part of multiple European grants and research programs for an additional 6.5 million US dollars in non-dilutive capital. All right. Well, thank you so much for being here. Welcome to the show. I'm so excited to speak with you today. [00:01:49] Dhruv Agrawal: it's a pleasure to be here, Lindsey. Thank you so much for inviting me. [00:01:52] Lindsey Dinneen: Of course, of course. Well, I would love, if you wouldn't mind just starting by sharing a little bit about yourself and your background and what led you to Med Tech. [00:02:02] Dhruv Agrawal: Yeah, absolutely. So I'm Dhruv Agrawal. I'm the CEO of Aither Biomedical. We are a company based out of Poznan in Poland, so on the western part of Poland. It's a little bit chilly here. As a company, we are a team of about 55 people right now, currently present in the US, Europe, Middle East, as well as India. And we focus on making bionic hands for upper limb amputees. [00:02:25] Lindsey Dinneen: Amazing. Yes. So I wanna get into everything amazing that your company does, but going back for just a little bit, in your own personal history, can you share a little bit about maybe growing up and what experiences led you to think, "Hey, in the future, maybe I wanna do X, Y, and Z." [00:02:43] Dhruv Agrawal: Mm-hmm. So first of all, entrepreneurship was never a plan for me. I didn't even knew that there was a thing called an entrepreneur until I was easily into high school. Both my parents are doctors. My dad's a pediatrician, mom's a gynecologist, and as it happens in India, if your parents are doctors, you kind of know that you have to become a doctor as well. So I went to the coaching classes to pre, to prepare for medical entrance examinations. I actually met my co-founder there about 10 years ago. We both got into medical school. I was generally comfortable with medicine, you know, growing up in a hospital with doctor parents around. So I was generally comfortable in a clinical setting, but I realized that I was much more interested in the technological aspect of medicine rather than the clinical aspect of it. And that was when I was getting into the second year of my university. And luckily my dad, for my 18th birthday, bought me a 3D printer, like a very simple 3D printer from China as my 18th birthday gift. 'cause I was really wanting to get into that world. And that's where the story begins. So even till today, my dad jokingly says that that's the worst gift he has ever bought for me, because that made me drop out of medical school. [00:03:57] Lindsey Dinneen: Oh no. Okay, so you were given this gift and you started, I imagine, tinkering with it, learning how to use it. So tell me about that. [00:04:06] Dhruv Agrawal: Yeah, the thing with my co-founder as well, even though we went to the same medical university, we were not really friends in the first year. We were just colleagues. But when I got this 3D printer, it was like one of those things that you assemble, you get a kit and you assemble. And I was asking around people in my university and they were like, "Come on, what are you doing? Like, I don't wanna come to your apartment to assemble a 3D printer." And my co-founder was the first one who said yes to coming down and assembling that printer with me. So that's how our friendship essentially started in the university, even though we had known each other for three years by that point. And then we started, of course, by very basic things like printing mobile phone covers and key chains and we were just in awe with the fact that I have something in my room, in a studio apartment, where I can just build physical things, right? And this was back in 2018, so 3D printer was not such a consumer product where, you know, if it was of course used in industry, but it was not something that you would imagine having at your home, at least not in India. And then we actually found out that there's a society called Enable, which is an NGO that makes very simple basic prosthetic designs for kids. So we started by printing those and started going to some amputee clinics around and trialing that out with patients, just purely out of technical curiosity. We didn't really had a draw towards amputation, so to speak. We were more driven by the technical curiosity of, you know, it sounds interesting to make a prostatic hand. So that was the beginning. And then slowly, slowly things happened very organically that we went from wanting to 3D print basic things to starting a biomedical innovation club in our university, to incorporating a company in India, then to coming all the way over to Poland and now having 55 people. [00:05:49] Lindsey Dinneen: Holy cow. That's an amazing story. Thank you for sharing about that. So, okay, so, so you started off with this curiosity, like, "Hey, let's see what we could do with this printer and, and how we can make it work for people." And I love that your initial pull with it was to actually provide something that does help people. So that's obviously a core value, something that you hold very dear. So can you speak a little bit more, did you have sort of any personal experience or within your family or what led you to say, "You know what, hey, I've got this really cool tool at my disposal. Let me start using it by actually doing something that helps others." [00:06:27] Dhruv Agrawal: I mean, the honest answer, I would love to say I had some personal experience, but the honest answer is no, not, not really. I don't have one of those stories where I can tell you that, like I met an amputee 15 years ago, 20 years ago, and have had that motivation for that time. It was just pure technical curiosity to begin with. But of course, as we started building basic devices and giving it out to people and seeing the response of what a very simple, you know, $50 thing can do for a person who's missing a limb in an impoverished family in a village in India, that's a very powerful thing. So at that point, we realized that we started getting more and more close to upper limb amputation as a field, as a clinical specialty within itself. Of course, both me and my co-founder coming from medical school growing up in family of medicals, we've always had it in our heart to work in the clinical side of things. We've always liked working around, helping people get healthier and better. But amputation specifically was an area that we were very lucky that we found as an area of interest that developed within the both of us. [00:07:31] Lindsey Dinneen: Yeah, of course. Okay, so, so you started printing these limbs, and then you realized, "Oh my goodness, there's such a need for this. There's so much opportunity here to really help people." So, so tell me a little bit about the evolution over time of how you have made it better and better, more technologically advanced, more ergonomic, all the things that go into that. Can you speak a little bit to that learning curve and process? [00:07:56] Dhruv Agrawal: Mm-hmm. Yeah, it was a very long learning curve because not only did, me and my co-founder had zero background in business. We were 18-year-old, 19-year-old kids, right? We were just teenagers and we really had no idea what we wanted to do. And not only that, we also were not engineers, so we didn't have any engineering experience or expertise either. So everything that we did in the very beginning, at least, was self-taught. I just knew I had an inclination towards electronics and programming. My co-founder was much more towards mechanical CAD design and things like that. So we started learning these courses for free on edX and Coursera and all these, you know, MOOC platforms. And that's how we built up the very first prototype of the product by getting some small grants here and there in India. Of course, the situation is very different right now. We have R&D team of 30 people, very experienced, a few PhDs here and there. So I don't really design anymore in my day-to-day life, but that's how we started. And same was the side of the journey of coming from India to Poland. Again, that was not something that was planned at all. We had no experience in business. We had no experience in raising funding or raising money and things like that. We just learned on the go, applied to over a hundred different programs 'cause most of the investors said no to us back then in 2018 to funding 'cause why would they say yes? And we looked at like, "Okay, can we get some grants and things like that?" Applied to over a hundred programs. Luckily got selected in this program in Poland, which was like a $50,000 program back in 2018 and decided, "Yeah, let's try that place out." And came to Poland. I literally came with a backpack with stuff for two months 'cause there was a plan, come for the grant, stay for two months, go back to my family in India, and it's been seven years since then. [00:09:44] Lindsey Dinneen: Oh, there you go. Oh my goodness. That's great. So Poland, and you get along it sounds like just fine. Excellent. Excellent. Okay, so, I really appreciate you sharing about, especially, you were both so young and but so eager. It sounds like just, "Yes, let's learn, let's develop the skills that we need to along the way." I would imagine though, coming into it, perhaps that young and not having as much business experience, or, or any really in, in the past, I-- something that I really admired when I was kind of looking through your LinkedIn profile was when you post, a lot of times you share stories about areas that, that may be considered I, I guess mistakes or stumbling blocks or things that, that you've overcome on your path. And I would love if you would share maybe just a couple of things that come to mind, as an early founder, because your story is amazing and unique, but there are lots of other founders too who find themselves in similar situations where they're like, "Whoof, I've got this great idea. I know what I want, but here's maybe what I should look out for to avoid." could you share a little bit about that? [00:10:49] Dhruv Agrawal: Yeah, absolutely. I mean, the first thing is mistakes are unavoidable, right? it doesn't matter whether you're coming from a background of a medical school dropout, or if you have 10, 15, 20 years of corporate experience and things like that. 'Cause I do find myself thinking a lot about, you know, wouldn't it have been better if I would've graduated and then did a MBA and then started a company? Yes, it might have been better, but the things that I deal with in my day-to-day life in the startup, I don't think this is taught anywhere. So the first and foremost thing, which is of importance, is that mistakes are unavoidable. It's okay to make mistakes. The biggest learning that I have is mistakes are unavoidable, but it's up to you to be decisive enough to pivot as quickly as possible. So don't look back at the mistakes that we have made, because one of the worst things that we have done in this company, or where we have failed the most, or where we have seen that like, "Ah, this is where we could have done things better," are not about making a wrong decision. They were just about being indecisive and being in a dilemma for a long, long time. It would've been far better if we would've made certain decisions quickly, gotten feedback and quickly pivoted, instead of just being in a dilemma and trying to balance two sides for a long time period. An example of that would be when we launched the first version of our product into the market, we realized that we had made some errors from the point of view of what should be the feature set in this product. And so, for example, the product was available only in a medium size hand in terms of the dimensions, but majority of the market is for a small size hand. So at that point we couldn't really just miniaturize things because there's a physical limitation. So at that point we had to make a decision of do we scrap this thing completely and build a new hand from scratch that starts with a small hand and then has a medium sized option as a grow up? Or do we continue to work on the medium sized hand, and then launch a small sized hand separately? Finally, we decided to do the second option. But looking back again, I, I don't think it would've been better or worse either way. I think both of these options are fair. It's just the fact that we spent over nine months going back and forth between, "Okay, let's continue putting our efforts in energy into the medium sized that we have right now" versus, "Okay, this month we are now suddenly feeling, ah, that's not gonna work out. Let's start building the second version." So that dilemma of indecision is probably the worst thing that you can do. Just make a decision, own up to it, move on. If it works out, great, if it not, if it doesn't work out, you're gonna have learnings and you'll be stronger at the end of the day. So that's, I would be an I would say would be an example of one of the key errors that we made. [00:13:23] Lindsey Dinneen: Yeah. Well, thank you for being willing to share that, and that's such valuable advice and feedback. And so, as you recognize this and go, "Okay, so that didn't work as planned, or in the way that I would prefer," what did you end up deciding? How do you go now, moving forward, when you are in a position of "I have a major decision to make. I feel like both options have value and merit." How do you end up deciding, "Okay, I I'm not gonna leave this just in this hazy middle ground, I'm gonna make a decision." How do you go about that now differently? [00:13:54] Dhruv Agrawal: I think the first and foremost thing that entrepreneurs, or anybody who wants to build a new product, or anybody who just wants to build something new, is be very, very, very honest with yourself about, "Am I solving a real problem?" As founders, as creators, as developers, it is so easy to go into that mindset of you find a problem that you can relate to or you somehow think that this is a real problem. It doesn't matter what feedback you're going to get. You're going to convert that feedback, or create a narrative or story from that feedback, that is going to align with the impression that you have built in your own head about what the real problem is. So one thing that we really do right now is just focus on problem market fit at the very early stages of launching a new software, building a new product, building the next version of the hand, or whatever else we do is really try to question, "Are we solving a real problem?" And in a completely unbiased manner, "Do people agree with me that I am solving a real problem?" So that's what I would say would be a primary thing that we do differently right now. Of course at this point, we start getting users involved much earlier into our development process. That is something that we did not do in the past, and hence the surprise that we got at that point. So we start involving users, different stakeholders, and things like that much earlier, but at the same time, I would say that it's not to say that I would penalize myself for the historical decisions that I took. We did the best that we could potentially with the resources that were available at that point. Now we have much more resources so we can do all these things. So don't feel pressured to do everything on day one. You know, start with something, move forward and build that maturity as you grow. [00:15:38] Lindsey Dinneen: Oh, I love that. That's excellent advice. Thank you for sharing. Yeah, so you know that's a great segue and I love the fact that you were talking about the end user and the importance. And it's so funny because of course, ultimately your goal is to help these end users and improve their quality of life and whatnot. But to your point, it does get easy to get so bogged down in the details of what you're creating and innovating that perhaps you forget sort of the bigger picture at times. So, speaking of these end users, can you share any stories that might stand out to you as really reinforcing to you that, "Hey, gosh, I am in the right industry, doing the right thing at the right time." [00:16:17] Dhruv Agrawal: Yeah, no, absolutely. So we have had many phenomenal end users that have reiterated our belief in the product that we are building, the problems that we are solving, the company, and the organization that we are building as a whole. I mean, generally speaking, patients change their devices every three to five years, and that's really our entry point of getting a device into the hands of the patients. But even with those, a patient is using another prosthetic device, they start using ours, they will see a step change in the functionality, and that's always empowering. But the most interesting stories are where we have really seen patients who, for example, congenital amputees tried a prosthetic device 10 years ago, 15 years ago, and then made a decision to live their life without any prosthetic device. So got used to a life for 15, 20, 25 years of living a life without a prosthetic device, just with an amputated limb or a limb difference. And then, we come in with our product, they see it, they use it, and they are ready to adopt that again. And that's a much powerful validation for us because somebody who has used a device, looked at all the advancements over the last two decades, decided actively decided to not use any of those advancements, and looks at our product and says, "Ah, this really solves the problems that I was waiting for someone to solve for the last two decades." Like we had this situation with a very famous Polish guy, Marek Kamiński, who is the youngest Polish person to go to both poles, North Pole and the South Pole, and he's a bilateral amputee on legs and he has a unilateral amputation to one arm. He has not used a prosthetic device in, I think 15 or 20 years, something like that. So for a very long timeframe. He met with an ambassador of ours and was finally convinced after 15 long years to give another try. And we fitted him over three months ago and he's been performing phenomenally with the device and he's so happy with that. So those are the moments that really give us more confidence or give us a boost of confidence in the product that we are building and the company that we are building. [00:18:19] Lindsey Dinneen: That's incredible. Wow. What a story. Yeah, and I love hearing those kinds of stories and that just to reinforce, " Hey, you really are making a difference." And I'm sure that helps on the days that are a little bit harder, a little trickier, you know, it helps to have that to hold onto, so you know your impact goes so far beyond even the places that you've mentioned before. I was reading about how you've worked with the Open Dialogue Foundation and there's been some work in Ukraine, and I'm wondering if you could share a little bit about perhaps that collaboration, and or some of the other exciting collaborations you have going on with these amazing organizations all over the world. [00:18:54] Dhruv Agrawal: Absolutely. I mean, the work that we do in Ukraine is something which is very close to our heart and what you just mentioned a moment ago, it's exactly that type of work that keeps us going on the hardest of days. I have so many amazing stories from the patients who have been fitted with our device 'cause at this point in the last year or so, we have already fitted over a hundred patients with our bionic hands in Ukraine. We primarily work with Superhumans, which is NGO based out of Kyiv, a great place, really the mecca for prosthetics at this point, I would say. They're doing a phenomenal job of getting these patients in, rehabilitating them, fitting them with our device and then training them on how to use the device. In fact, even supporting them in the post rehabilitation, acquainting them to back to the real world as well. And we send teams of doctors from the US, from Poland, to Ukraine to actually fit these devices to patients. And we have had a lot of success stories come out of it. We have people who have amputations, even at the level of shoulder who are amputated all the way up to the shoulder or four quarter amputation, and they are successfully able to live a independent life with our device. I think the best story that I've had, or the part that really made me tear up, was when one of the soldiers got fitted with our device and his really, really big wish was to be able to do the first, to dance with his wife, with both hands. And I got to see that and it was, it was the most amazing feeling ever. [00:20:20] Lindsey Dinneen: Oh my goodness. Yes. I don't know how you couldn't just have the waterfall start with that kind of story. That's incredible. Thank you for sharing about that. So, as you look toward the company's future and your own, what are you excited about moving forward? [00:20:34] Dhruv Agrawal: I mean, we are currently in the process of getting a new version of our hand in the market, which has all the learnings of the last four years or so. So we are definitely really excited about that. You have to keep in mind when we launched the first product, we didn't even have enough money to-- because prosthetics are expensive-- so we didn't really have had enough money to buy our competitor devices, or the devices from the past to look around to see, touch, feel, how they are built. Everything that we built was purely out of our imagination and based on what we could find on the internet. And, you know, go visit a doctor who fits these devices, have that 10, 15 minutes to look around that device, and so on and so on. I mean, four years later, now we have the experience of fitting close to seven, 800 patients with our device. All that feedback that has gone into the next version product that we are gonna be building. So very excited about that. We continue to develop the software platform, so we are not just a company that is focused on providing a device to the patient, but we provide an entire software platform that's like a digital twin for the patient. So it supports the patients throughout their end-to-end journey. Because it's not just about giving a device to the patient, but it's all about can we improve their quality of life? Can the patient pick up a glass of water? Can he tie his shoelaces? Can he water a plant? Can he do the activities that he really wants to do? And from that perspective, the software platform that we continue to build focuses on things like adherence, occupational therapy, physical therapy, monitoring of the usage of the device. Because the thing in prosthetics industry is, the day you give the device to the patient is not the day you have won the battle. That's the day the battle actually begins, 'cause now it's all about making sure that you deliver on the promise of helping him get better quality of life. [00:22:20] Lindsey Dinneen: Yeah. Yeah. I'm sure that's an exciting challenge, but it's a continually evolving challenge too. And there's probably variations, I would imagine, on people embracing the technology a little bit differently and how you handle all that. Yeah. Excellent. Well that is a very exciting future and it's so much fun to hear about, and you know, you've had a great career so far. I'm sure it's wildly different than what you may have imagined as a kid. But what a cool gift that you're bringing to the world. You've been recognized quite a bit. You're 30 under 30 for Europe, and you've been involved in lots of different cool organizations. You've been a TEDx speaker. What are some of those moments like, have they been surreal? Is it just like, "Oh, thank you." Just confirmation that, hey, you are on the right tracker. What are those kinds of moments like for you? [00:23:08] Dhruv Agrawal: I mean, definitely the first round of funding that we raised in Poland was was a huge check mark for us, because it's that moment at which you realize, "Ah, somebody wants to give me money and somebody wants to give me a quarter of a million dollars." I've never seen that much money together on a single bank account or in any way, shape or form, right? I come from a normal middle class family. We don't have that. So, that was definitely the first micro checkpoint, let's say. I mean, both the things that you mentioned, the TEDx thing, the Forbes 30 Under 30 thing, coming from a background in India where these things are really important, although they're not so important for me as a person, but they're much more important for some reason to my parents and to society. It is a different place. We put a lot of emphasis on these types of things. So from six, seven years ago, looking at these lists coming out or looking at, "Oh, this cool guy spoke on a TEDx talk, sending him an email about, 'Do you want to be an advisor in my company? I'll give you 5% shares,'" and so on and so on, to actually doing those things by yourself, that's definitely pretty well as well. But again, at the end of the day, there is nothing better than seeing a new patient get fitted with the hand, seeing the reaction of their family members. They have a daughter, they have a son who they hold their hand for the first time. They hug their wife. I mean, just, just being around amputees and patients who use your device, something that you built and that helps them get better at their daily life, that's, I would say, the most rewarding thing ever. [00:24:39] Lindsey Dinneen: Yeah, of course. That's, that's wonderful. Yeah. So, oh my goodness, this is so great and very inspirational, but pivoting the conversation a little bit just for fun. Imagine that you were to be offered a million dollars-- speaking of those wonderful sums of money-- to teach a masterclass on anything you want. It can be something within your industry, but doesn't have to be, what would you choose to teach? [00:25:03] Dhruv Agrawal: I have two topics in mind. One is I would probably teach a masterclass on pitching, especially for first time founders. I think that is something which I'm good at, and we have obviously raised a pretty decent amount of capital up 'till now. So that would be the one thing that I would say. So kind of a combination of pitching and starting a startup for the first time, especially in the field of hardware, medical devices, things like that. And the second thing that I would really like to talk about is just probably trying to put my thoughts together and making a masterclass on how to never give up, because I think that that's a very underrated quality. But that's a very important quality. There have been complex times in the history of our company where we have felt that like, "Ah, this might be it." But it's all about what you do in those moments and how you go beyond those. I think it's all about that. [00:25:47] Lindsey Dinneen: Yeah, absolutely. And how do you wish to be remembered after you leave this world? [00:25:53] Dhruv Agrawal: Just as a positive change maker. I really would like all these patients that we are helping and giving these devices to. I, I just want to be a small part of their lives. Just as I was part of the life of the veteran who got married, I, I just wanna ha have those small moments club together amongst these different individuals that we are privileged to work with. [00:26:13] Lindsey Dinneen: Hmm. Yes, of course. Wonderful. And then final question, what is one thing that makes you smile every time you see or think about it? [00:26:22] Dhruv Agrawal: Oh, that's very simple. Patients getting fitted with our device. Today we see a patient getting fitted with our device, and that smile on their face and things like that. And, you know, that's even much bigger, much more interesting in Ukraine because many times when you go to these hospitals, and when I go to these hospitals in Ukraine, you have to understand that these people have gone through a lot. These soldiers who are putting their body on the line for their country. There, of course, there's a certain sort of low morale that they have when they're amputated and when they're in these hospitals and things like that where they don't really think that there is ever a possibility for them to regain something back. And you go in there and you show them a bionic hand, and they're not sure if this thing works, and you put the electrodes on them and they open the hand or close it for the first time, and then you suddenly see those expressions change from like, "Ah, what has happened to me?" to, "Oh, what can I achieve?" That is also an amazing feeling. [00:27:16] Lindsey Dinneen: Yeah. Oh, I love that. What an amazing gift to be able to help somebody bridge that gap and witness it. How cool is that? Oh, well, I think this is incredible. I am so grateful for you and your co-founder for starting this company and just being able to give so many people hope and new life, really, just a new way of experiencing life. So thank you for all of the incredible work you're doing. I'm so excited to continue to follow your work, support your work, as I'm sure all of our listeners are as well. So, gosh, I just really appreciate you sharing all of your advice and stories and wisdom with us. So thanks again so much for being here. [00:27:55] Dhruv Agrawal: Of course, Lindsey, thank so much for having me. [00:27:56] Lindsey Dinneen: Of course, of course. 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. I just wish you continued success as you work to change lives for a better world. And thank you also so much to our listeners, and if you're feeling as inspired as I am right now, I'd love it if you share this episode with a colleague or two and we'll catch you next time. [00:28:43] 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.

What if the key to solving the provider burnout crisis wasn't adding more hours in the day—but using technology to give them back? In this episode of Med Tech Gurus, we meet David Norris, Co-Founder and CEO of Affinion Health. David shares how his company is building an AI-powered clinical inbox that helps clinicians manage the overwhelming flood of lab results, patient messages, and admin tasks. With measurable results like five hours of reclaimed time per week per provider, David explains how Affinion's solution is not just about efficiency—it's about restoring balance, improving care, and preventing burnout. From his work with the Coalition for Health AI to his lessons in entrepreneurship and team-building, David offers practical wisdom for every MedTech innovator in this episode.

In this episode of Medsider Radio, we sat down with Joanna Nathan, CEO and co-founder of Prana Surgical — a startup developing image-guided surgical platforms for precision oncology.  Joanna's career spans translational research at Texas Heart Institute, product development at Saranas, and portfolio management at Mercury Fund and Johnson & Johnson's Center for Device Innovation. She mentors founders through her not-for-profit organization Enventure and teaches entrepreneurship at Rice University's Jones School of Business.In this interview, Joanna shares her framework for evaluating which medtech ideas merit pursuit, revealing three critical signals every founder should look for: clinical urgency that requires no convincing, favorable asymmetry between value and technical risk, and optimal market timing. Joanna also demonstrates how systematic grant applications and strategic resource allocation can extend runway while building investor credibility, and addresses the unique psychological challenges of building life-critical devices.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Joanna Nathan.

In this milestone episode, I reflect on what it's taken to record, edit, and release 200 episodes focused on medical devices, pharma, and combination products.I share three hard-earned lessons not just about the industry, but about how we grow, lead, and keep learning inside it. From the sheer scope of the work to the surprising, non-linear paths people take, and the difference between credentials and true insight this episode is about what finally clicked… and what still hasn't.It's a thank-you to you, the listener, and a reminder that mastery isn't a finish line it's a mindset.

In this episode of RCA Radio, host Brandon Miller is joined by cybersecurity experts Jason Tugman of Regulatory Compliance Associates® and Mustanger Ali of BSI to unpack the evolving landscape of cybersecurity in medical devices. Together, they explore the latest FDA and EU guidance, the growing expectations for connected device security, and the top gaps companies face when bringing products to market. From threat modeling and SBOMs to legacy device challenges and global regulatory alignment, this episode offers practical insights for MedTech developers navigating today's complex cybersecurity requirements. Whether you're launching a new device or updating an existing one, this conversation is packed with actionable advice to help you stay secure and compliant. 

Dr. Brittany Partain, Associate Director of Clinical Affairs and Physician Education at Exagen has a background in biomedical engineering and a passion for problem-solving, Brittany has carved out a unique role at the intersection of diagnostics, clinical education and biotech innovationIn this episode, we explore why autoimmune diseases like lupus and rheumatoid arthritis are so difficult to diagnose, and how Brittany is helping close that gap through physician education and the use of novel T-cell biomarkers. We also talk about building trust with clinicians, misconceptions around diagnostic tools, and the real challenges of advancing innovation in a field that's historically lagging behind specialities like oncology. Finally, Brittany reflects on her journey as a female leader in MedTech, the importance of collaboration, and why passion matters when navigating a fast-paced, highly regulated industryTimestamps:[00:00:45] Why Autoimmune Diseases Are So Difficult to Diagnose[00:01:55] From Biomedical Engineering to Clinical Affairs[00:04:34] Why Rheumatology Has Lagged Behind[00:07:07] How T-Cell Biomarkers Work and What They Solve[00:09:18] What Autoimmune Diseases Are and How They Present[00:11:05] Common Misconceptions Among Clinicians[00:13:00] How Hospitals and Private Clinics React to New Tools[00:15:07] Building Clinical Trust Through Science[00:18:05] What Most People Don't Know About Autoimmune Disease[00:21:58] Women in Biotech: Breaking Stereotypes and Leading ChangeGet in touch with Brittany - https://www.linkedin.com/in/brittany-d-partain Learn more about Exagen - https://exagen.com/ Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/ Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwalSubscribe to the Podcast

In 2025, we're embarking on a MedDevice Training Journey: From clinical trials to standard of care. Join us all year long as we explore training at each stage of the product life cycle.Need help developing your clinical trial training strategies? Contact us at training@cumbyconsulting.com.Related Resources:Tony Recupero is President, Commercial Operations of SI-BONE. Tony leads SI-BONE's commercial operations, including sales, market access, reimbursement, professional education and international. He is a proven commercial leader, responsible for the company's go to market strategy that has led to exponential revenue growth. Prior to SI-BONE, Tony was formerly the President of Catalyst Performance Advisors where he advised several medical device companies on commercial strategy. Tony was previously President and CEO of Baxano, Inc. Tony was also the Vice President of Sales for Kyphon from startup in 1999 through the end of 2004. Kyphon was acquired by Medtronic for $4.2 billion dollars. Early in his career, Tony progressed to senior sales management roles at United States Surgical Corporation and Sulzer Spine-Tech, Inc. Tony earned a B.A. in Communications from State University of New York at Albany and attended The General Management program at Harvard Business School.Subscribe to our newsletter to hear more about the journey from clinical trials to standard of care! Click here to subscribe! Connect with us on LinkedIn: ⁠⁠⁠⁠⁠⁠⁠⁠⁠Tony Recupero⁠⁠⁠⁠Cumby Consulting⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Rachel Medeiros⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Liz Cumby⁠⁠⁠⁠⁠About Cumby Consulting:Cumby Consulting's team of professionals deliver innovative MedTech training services for physicians, sales representatives, teaching faculty, key opinion leaders and clinical development teams. Whether you need a complete training system developed to deliver revenue sooner or a discrete training program for a specific meeting, Cumby Consulting will deliver highly strategic, efficient programs with uncompromising standards of quality.

Health Connective COO Justin Bantuelle and company president Scott Zeitzer join host Michael Roberts to share insights into what medtech companies need to be thinking about when working with a developer to create a prototype for their app. Find out what you should and shouldn't include, the questions you should be asking of your development partner, and red flags to look out for. Hosted on Acast. See acast.com/privacy for more information.

Heartflow, a California-based medtech company specializing in AI-driven cardiac diagnostics, plans to list on the Nasdaq under the ticker HTFL, offering 12.5 million shares at $15 to $17 each and targeting a valuation up to $1.3 billion. The company received FDA approval in 2022, expanded its market through Medicare and AMA regulatory changes, and has assessed over 400,000 patients as of March 2025. Heartflow reported $125.8 million in 2024 revenue, a 44% increase from the previous year, but posted a net loss of $96.4 million and expects continued losses. Major investors include Bain Capital, Panorama Point Partners, and Capricorn Investment Group. The IPO follows a previous canceled SPAC plan and recent public listings by other medtech firms.Learn more on this news by visiting us at: https://greyjournal.net/news/ Hosted on Acast. See acast.com/privacy for more information.

Il était une fois un business…Mais aujourd'hui, ce n'est pas n'importe quelle entreprise que nous allons découvrir. C'est celle de Louis-Philippe Broze, cofondateur de Spentys. L'histoire que nous allons vous raconter n'a rien d'un conte inventé : c'est le parcours atypique, mais bien réel, d'une start up qui est née sur les bancs de l'université et qui a réussi à percer dans des marchés complexes, ceux de la MedTech et de la santé connectée. Un récit inspirant, mêlant philosophie humaine à appliquer dans chaque expérience, et conseils concrets pour gérer l'hypercroissance d'une scale-up (marketing, finance, recrutement, produit et commercialisation).Quand les stratégies business d'une scale up s'alignent avec la philosophie inspirante d'un CEO : on vous dit tout dans ce 24ème épisode. Hébergé par Ausha. Visitez ausha.co/politique-de-confidentialite pour plus d'informations.

Local political announcements; Highway 113 relocation projection now completed; firefighters respond to weekend blaze; pilot instruction school opens at Morrilton airport; MedTech employees earn awards; we talk with Alisha Koonce of Sacred Heart Catholic School.

The $600 billion MedTech industry is undergoing a technological transformation. From AI-powered medical imaging to smart diagnostics and remote monitoring tools, artificial intelligence and machine learning are reshaping how care is delivered — and increasingly how patients manage their own health. In this episode of the BioRevolution podcast, we are joined by our guest, idalab's MedTech expert Julian Beimes to discuss how this AI-driven wave aligns with broader shifts in medicine: virtualization, personalization, and prevention. But alongside the innovation, we also unpack the challenges — especially the complex and often fragmented regulatory environment. Are policies like the EU AI Act promoting safety, or holding back progress? Find Julian here: https://www.linkedin.com/in/julian-beimes/ Find idalab here: https://idalab.de/ Disclaimer: Louise von Stechow & Andreas Horchler and their guests express their personal opinions, which are founded on research on the respective topics, but do not claim to give medical, investment or even life advice in the podcast. Learn more about the future of biotech in our podcasts and keynotes. Contact us here: scientific communication: https://science-tales.com/ Podcasts: https://www.podcon.de/ Keynotes: https://www.zukunftsinstitut.de/louise-von-stechow Image: Igor Saikin via Unsplash

What if surgeons could eliminate the guesswork from complex procedures and walk into the OR with a personalized, pre-fitted solution ready to go? In this episode, we meet Vikram Ahuja, Co-Founder and CEO of OsseoLabs, who is transforming orthopedic and maxillofacial surgery using AI and 3D printing. Vikram reveals how his platform builds patient-specific implants using biomechanical data—dramatically reducing OR time, complications, and the need for revision surgeries. With over 170 successful cases and 40 hospital partners across Southeast Asia, Vikram shares what's next, what's needed for U.S. expansion, and how OsseoLabs is pushing the boundaries of surgical precision. If you're serious about MedTech innovation, this one's essential listening.

Avner Spector is the founder of Curespec, a MedTech company that developed a non-invasive device using low-intensity acoustic shockwaves to restore kidney function and lower blood pressure. Avner brings over 30 years of medical technology experience and has led advanced R&D in leading medical instrument companies worldwide. Avraham and sat down with Avner to discuss how their technology works, how he came up with the idea, how he got funded, how he's marketing their product, tips for startup founders and much more. Do you have a great innovation? We'd love to hear from you. Contact us by going to https://jmbdavis.com/startup/contact. Learn more at https://jmbdavis.com and https://jmbdavis.com/startup. Also available at https://soundcloud.com/jmbdavis/ avner-spector-of-curespec. Listen to all of the episodes at https://jmbdavis.com/podcast.

In this episode of Medsider Radio, we sat down with Greg Lipschitz, CEO of Firefly Neuroscience. Firefly's FDA-510(k) cleared Brain Network Analytics (BNA™) technology objectively measures brain function through EEG analysis. With a proprietary database spanning twelve cognitive disorders, the company serves both clinical practitioners and pharmaceutical partners.Greg brings extensive experience in private equity, investment banking, capital markets, and finance to his leadership role. As Managing Director of Old Stone Advisors and former Vice President of Lazer Capital, Greg has advised on over $1 billion in transactions. He is a Chartered Financial Analyst.In this interview, Greg shares insights on strategic fundraising approaches, platform prioritization decisions, and building commercial momentum in healthcare through direct sales and customer feedback loops.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Greg Lipschitz.

Niche markets and small populations don't get the attention they need for medtech and healthcare.  Medtech Talk host Swaril Mathur speaks with Eric Chehab, founder and former CEO of Novonate and director of business development of Laborie OB/GYN/NICU, and James Wall, pediatric surgeon and founder of Impact1 at Stanford University, about how they're bringing medtech innovation to small towns and other low-population areas. They delve into their experiences of founding their own niche market companies and the lessons learned, including how they navigated commercialization and acquisition processes, convinced the right investors, determined capital efficiency, and more. They also share their thoughts on investors who think niche solutions for niche markets are uninteresting. Medtech Talk Links:  Cambridge Healthtech Institute   Medtech Talk  Gilde Healthcare  MicroTransponderLinks: MicroTransponder Stanford University Links: Stanford Healthcare Stanford Medicine Children's Health Stanford University Laborie Links: Laborie 

What if the way you've been selling is working against you, and your customer can feel it? In an industry built on outcomes, many MedTech reps still get caught up in pitching features, checking boxes, and pushing for yeses. In this week's episode, sponsored by Physician Growth Accelerator, sales coach, author, and founder of Kiinetics, Brendan McAdams shares how shifting from a sales-first mindset to a fit-first mindset changes everything. From running smarter discovery and setting up collaborative problem-solving to wrapping the call with radical clarity, he explains how trust is built not through persuasion, but through partnership. Whether you're in a startup or a Fortune 500, this episode will challenge how you think about selling—and give you practical tools to do it better. What we discuss in the episode: Why thinking beyond the immediate buyer leads to better customer alignment How to run a sales call that builds trust instead of resistance The power of curiosity and collaborative problem-solving in MedTech Why wrapping up the call with clarity is essential The underrated art of “killing the deal” when it's not the right fit Why premature selling can backfire and how to slow down for strategic success Resources from this episode: Get the free MedTech Talk Tracks for Action Get Brendan's Book Physician Growth Accelerator Social Media: Connect with Brendan on LinkedIn Connect with Zed on LinkedIn

The focus of this podcast episode is the critical importance of evaluating Electronic Quality Management Systems (EQMS) platforms at the appropriate stages of product development rather than waiting for a crisis to prompt action. I explore how proactive medtech teams that prioritize early evaluation of EQMS platforms position themselves for success, ultimately enhancing their capacity to bring safer and more effective medical devices to market. Joined by industry expert Andy Rogantino, we delve into the intricacies of when and how teams should consider EQMS solutions, emphasizing the necessity for a foundational quality system that supports regulatory compliance and operational efficiency. Our discussion also highlights the essential collaboration among product development, quality assurance, and leadership to ensure that the chosen EQMS aligns with the unique needs of each organization. By understanding these dynamics, we aim to equip medtech professionals with the knowledge to make informed decisions that will positively impact patient outcomes and organizational success.naTakeaways: The most effective medtech companies evaluate EQMS platforms early in their development process to avoid regulatory headaches later on. Quality management systems should be viewed as the backbone of medical device development, essential for improving patient outcomes and compliance. Companies need to adopt a proactive mindset in quality management, as waiting for issues to arise can lead to dire consequences. A successful EQMS implementation requires collaboration across various departments including regulatory, quality, and product development. It is crucial for medical device teams to consider the user experience of the EQMS software, ensuring it is intuitive and effective for everyday use. Evaluating the ROI of an EQMS should encompass not only financial metrics but also improvements in efficiency and compliance readiness. Links referenced in this episode:www.greenlight.gurupodcastreenlight.guruCompanies mentioned in this episode: AbbVie Signal Therapeutics Second Nature Greenlight Guru

Nidhi Oberoi is a dedicated medtech executive with over 17 years of experience and currently serves as Business Leader, Imaging Franchise at Terumo Medical Corporation. She discusses her journey from India to the heart of the medtech industry, her impactful work on innovative heart valve treatments while at Medtronic, and her advocacy for women's health. Nidhi shares her leadership philosophy centered on empowerment, the importance of mindfulness in business, and her vision for a future in cardiology and women's health.   Guest links: https://www.linkedin.com/in/nidhi-oberoi-278a111/ Charity supported: Save the Children Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 060 - Nidhi Oberoi [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I'm excited to introduce you to my guest, Nidhi Oberoi. Nidhi is a seasoned MedTech executive dedicated to the mission of serving clinicians and patients. With over 17 years of experience working on commercialization of innovative technologies, She has led various strategic and operational initiatives that have transformed standard of care. Her bold, collaborative, and empathetic leadership style allows her to push boundaries and inspire teams to create durable value. She currently leads business initiatives for the structural heart business in Medtronic, which serves patients with heart valve disease. She's also an advocate for evidence based care for women's health. Nidhi has an undergraduate degree in economics from India and an MBA in marketing and entrepreneurship from Syracuse University. Thank you so much for being here, Nidhi, I'm so excited to speak with you. [00:01:44] Nidhi Oberoi: Yeah, thanks for having me. [00:01:46] Lindsey Dinneen: Of course. Well, I would love, if you don't mind just starting off by sharing a little bit about yourself and your background and what led you to MedTech. [00:01:56] Nidhi Oberoi: Yeah, absolutely. I was born and raised in India, and just like any typical Asian Indian household in those days, if you were a bright student, you were generally expected to pursue a track in sciences, medicine or engineering, or maybe a second option in accounting and finance. Predictably, after I completed my high school, I was on my path to pursue a career in sciences. But then I changed courses and ended up pursuing an undergraduate degree in economics, and eventually an MBA in marketing and entrepreneurship from upstate New York. Now, as I reflect back and realize that what attracted me to business eventually, it was this realization that it's both in art and a science. The science aspect helps to ensure that the business can financially run smoothly with a strong P&L, while the art side of the business is the ability to set the vision, the direction, inspiring people, innovating, connecting with people. So what I really was interested was in a career in marketing and general management. You asked me what led me to medtech, I'd say my entry into the healthcare industry was by chance. I got recruited into this industry through a summer internship when I was doing my MBA with a company called Conva Tech, which was part of Bristol Myers Squibb then. And by the time I had completed my internship, I already knew I wanted to be in the healthcare industry given the impact you have on the patient's lives. I did have opportunities to interview with other companies like Philip Morris and others, and I just decided that this is what I wanted to do. And after I graduated, I started working for a company called Covidian, which was then a spinoff from TCO International. And Covidian was eventually acquired by Medtronic. It's been 16, 17 years since I've been working for this company and it has a really strong mission of elevating pain, restoring health, and extending life of patients around the world. So that's that's my story there. [00:04:07] Lindsey Dinneen: Excellent. Thank you so much for sharing that. I'm curious. Of course your career trajectory has been really interesting and you've had a lot of different experiences along the way. So what are some of the key things that say maybe your schooling or your early career really set you up for success for what you're doing now? [00:04:29] Nidhi Oberoi: Yeah, so there's just so many different experiences that either have shaped my interest, where I wanna go, or has shaped my leadership style. Now, as I mentioned, I decided to move away from sciences to a more kind of social sciences field, economics and then business, and that was due to the fact that I was not the person who could just crunch numbers sitting on the table. I liked connecting with people. So I think some of those personality traits helped me decide what I wanted to do. And I would say one of my core value is impact, purpose. And so healthcare, it was just natural for me to gravitate towards healthcare because you are truly impacting people with different technologies. And I'd also say, as I grew further along in my career, early on when I joined Covidian, I had some great leaders who gave me a lot of ownership, and that shaped my leadership style as well. And that's how I operate. I empower my teams. I coach them along, but give them a lot of accountability. So there's so many different experiences, but these are some of the experiences that come to mind as. As as I reflect back now what that has shaped my career and also my leadership style. [00:05:55] Lindsey Dinneen: Yeah, absolutely. And speaking maybe more into your leadership style, I'm really curious if you could tell us a little bit more about that philosophy of yours. I love that ownership mentality. It sounds very counter to what a lot of folks don't appreciate, and that's micromanagement. And so I'm curious, how do you bridge the gap yourself as a leader between making sure that, your team stays on track and the goals and really key, important performance indicators are met, while also giving them that ownership and that empowerment to make decisions and do things in a way that best aligns. [00:06:35] Nidhi Oberoi: Yeah. So I think there's so many different facets of leadership, and let me highlight some of the others that feeds into the third aspect, which is the empowering team. So I think as a leader, first thing first, you need to provide clarity, direction, focus. I've been part of so many different teams where if people can relate to what they're doing, why they're doing, they can get lost, right? So I think that's the first thing. You need to have the ability to cut through the noise, provide direction to the team, organization you're leading. And then the second part is inspiring and bringing people together to execute on that vision. So this is the culture piece. You are listening to others, you're hearing others' perspectives and being inclusive. And the last thing, which I mentioned early on, is empowering your teams and making them accountable. So to your question of how you bridge the gap, I think you have to give clear direction. And when you empower teams doesn't mean that you don't coach them, right? You are just telling them that you trust them to do the job and you are here to help them. And one of the technique that I use is I ask questions, so I don't give answers. When you ask someone in your team to lead the project, they come to you. Then you ask questions. And I've seen, based on my experiences, that gives them a sense of ownership that this is something they're thought through. And oftentimes I've heard from people that they feel like they become a better version of themselves because I ask a lot of questions. I make them think. So that's my approach on how I kind of bridge the gap, but also make sure along the way that you're supporting them in the right direction. [00:08:24] Lindsey Dinneen: Absolutely. Yeah, and you mentioned as you were speaking a little bit towards how your past experiences shape who you are and how you kind of relate to the world now, you mentioned core values, and I would love, if you don't mind, if you would share a little bit more about your core values. I noticed that on your LinkedIn profile, that was something that was very highlighted as being extremely important to you, which I love. I'd love if you would share a little bit about maybe how you developed your core values and how those play out for you. [00:08:57] Nidhi Oberoi: Yeah, absolutely. I think core values is something that you always have, but you just sometimes need a little bit of handholding to unfold those, right? And so in my case, a few years back, I had an opportunity to work with a coach, and she really helped me understanding what I'm good at. These are things that you already have, but you may not realize or you may not know how to articulate. So for me, the number one thing that came out was purpose. And I'm like, "No wonder I'm in the healthcare industry. I'm big on impact. I like building things." And so that's where it's coming from. The other core value of mine is excellence. I like to do things with excellence. I put my heart and soul into things. I'm a very passionate person. But also you gotta have an eye on quality versus decision making, right? Over time, I've learned excellence is my core value, but it's a journey, it's a process. It's not a destination. So you don't have to dwell on things. Sometimes things go wrong and you just have to keep moving on and have a growth mindset. So there's a good aspect of the value, but there could be a blind spot, like in this case for excellence and I've learned to manage that as well. And yeah, so I think these are some of the core values, which is, I think, also part of being a leader. You have to have self-reflection. You need to dig deeper and understand what you stand for. And, this has just guided me along the way. And yeah, so those are some of the things that I'd say has really helped me all along in my career. [00:10:41] Lindsey Dinneen: Yeah, of course. So, tell me a little bit more about your current position and what are you looking forward to as you move forward in your own career as well? [00:10:53] Nidhi Oberoi: Yeah, currently I'm in the structural heart space, and these are really old and sick patients. And it's just amazing to see these patients getting impacted by our technology, getting back to their day-to-day life. And as part of structural heart, also, most recently I've been able to work on therapies. I've been focusing on the congenital portfolio, which is, these are devices that are used to treat patients that have congenital disease, and it's very impact driven because you're dealing with children here who tend to get multiple surgeries throughout their lifetime. So my role right now is to focus on business initiatives. Some of it is expansion across geographies. Some of it is increasing supply for these products. I mean, there's not a big business case for these kind of products, but the impact is huge. So that's my current focus. And, moving forward, in my career, I'm looking to grow into a general management track, and that's what attracted me to marketing because I consider marketing as running a business within the organization. So for me, running a business would be something that I would be looking forward to. And that's why I have spent time in so many different kind of roles, whether it's marketing, it's commercial transformation, whether it's global roles. So that's how I've been building my skillset so that I can one day lead a business. [00:12:25] Lindsey Dinneen: Yeah, that's very exciting. Okay, so you're building all of these skill sets. You're working towards this incredible goal. Do you have an idea of what kind of business you would want to get into? Or is this, " We'll see," and I'll interview you again when that happens? [00:12:38] Nidhi Oberoi: Yeah, I think cardiology, there's so much opportunity in cardiology. There are so many people getting impacted by cardiovascular disease around the world, and there's so much innovation too happening, not just on the treatment side, but also on the diagnostic side. So I would say either something in the cardiology space would be very attractive because it's innovative. There's such a huge population that gets impacted by it. Or the other area of interest for me is women's health, and I think it just makes me smile how there's progress being made. I know there's so much work that needs to be done. We know there's not enough evidence, it's underfunded, but I think the work is starting there, and better evidence generation will lead to better decision making, which will lead to better outcomes. So I would say either in the cardiology space or the women's health space, these are the two areas of interest to me. [00:13:38] Lindsey Dinneen: Yeah. And I noticed again, with LinkedIn, you are very passionate about women's health and I love that. And I am wondering if you could speak a little bit towards some of themes that I kind of picked up on, things like stigma with women's health, medical gaslighting and self-diagnosis. And I know there's a lot to that and it's probably too much for one conversation today, but can you highlight a couple of the areas that you particularly find concerning, that are things that we can all do better? [00:14:11] Nidhi Oberoi: Yeah. Yeah. I think first of all there's such lack of education and awareness. As women transition through different stages of life, I feel like a lot of it is taken for granted. We don't question it. And as someone who's been following this for a little bit of a time, I almost feel like it's my duty and being in the healthcare industry, to raise awareness about this or encourage them to be more educated patients. When they go to a doctor, if they don't get answers, they should ask more questions. So I think, so that's that lack of education and awareness piece. There's a lot of work happening. There's so many advocacy groups. Women are coming together, supporting each other, so I think that's happening as well. The other thing that really bothers me is on the diagnostic side. I wrote an article around women get mammograms. Just because there's not enough evidence out there, sometimes you just have to go through a number of tests to have a diagnosis, either a positive or a negative. So I also feel like maybe the advent of technologies like AI in the diagnostic field can help improve that, because it starts with the diagnostic side, and we just don't have enough right now. And like I said, it can either be a good thing or bad thing. I've also heard of women going through a number of tests to find out that they don't have anything, which is fine, but it's just a lot of money along the way getting to the diagnosis. And then, the third thing I'd say is as we get more intelligent with evidence, it will lead to better awareness among the physician community too. And that's what gaslighting comes because there's not a lot of evidence, there's not a lot of awareness. Even physicians sometimes can't guide you in the right direction. But if you have more studies coming out, it will make them more aware and guide their patients in the right direction. So there's just so many different things, but I feel like you could start being a self-aware patient and not just assume as you go through different stages of your life that this is what it comes being with a woman. Be more proactive, ask questions, research, talk to other people and get help. [00:16:32] Lindsey Dinneen: Yeah. Yeah, that's really great advice, and I appreciate your perspective in sharing with us a little bit about maybe even some of the things that we all can do as we're trying to hopefully push the quality of women's healthcare forward and make it more widely available and whatnot. So thank you for sharing. As you have been going throughout your career-- and you obviously care so much about purpose and you have a lot of passion for helping people and for the healthcare industry in general-- are there any moments that really stand out to you as affirming, "Hey, I am in the right industry at the right time?" [00:17:11] Nidhi Oberoi: Yeah, there's been so many moments and I would say most of these moments are when I've interacted with patients. When I started with Covidian, I was leading an initiative which would help a lot of women who were having open hysterectomies-- this is like 10, 15 years back-- to have a minimally invasive hysterectomy through a new procedure technique. So it was called single incision surgery. And I happened to talk to some patients, and it was just amazing to hear those stories where they were telling me how they could get back on their feet, travel, within just a week after the procedure. So that's the defining moment. And then, when I was working on one of the businesses where patients have very varicose veins, I met a patient who was a mom of four. So she had four kids within a span of six, seven years, and she had very visible varicose veins on her legs. And that impacted her quality of life. And when she got the procedure done with our technology, she was just so happy. It was not just cosmetic, but also less painful, and being more present with her kids because of that. And then I'd say most recently in the cardiology space, these are really sick patients, older patients with multiple conditions, and just hearing their stories of getting a new heart valve, it's amazing to see how, again it's getting back to life. So it's always, when you meet these patients, those are the defining moments, and it just reaffirms why you're in healthcare and why you need to continue to work in the healthcare space. [00:18:58] Lindsey Dinneen: Yes. I love that so much. Yeah, so pivoting the conversation a little bit just for fun. Imagine that you were to be offered a million dollars to teach a masterclass on anything you want. It can be within your industry. It could be related to anything your background, your experience, but it doesn't have to be. What would you choose to teach? [00:19:19] Nidhi Oberoi: Yeah, that's a great question. I don't think I have an expertise right now, but maybe something on mindfulness and yoga. One of my goals is to do a yoga teacher training, but the importance of mindfulness in business. There's so many things you can do: power walks, taking a break, journaling. These are so underrated, but I think these things are necessary. It's more important than ever now, given the fast change. There's so much, so many changes happening at such a fast pace. So I would say that would be my topic, but I don't think I'm ready yet to have that masterclass. [00:20:03] Lindsey Dinneen: Fair enough. Fair enough. So I'm curious, how long have you been incorporating these kinds of really important mindfulness practices into your own life and your own routine. Is this something that you've had for years and years or is it a more recent development? [00:20:19] Nidhi Oberoi: Yeah, I think it's more recent. I would say three to four years, although I wonder why I did not do that. I think within the organization, as you are managing multiple things, it just forced me at that point of time when I was juggling a lot of things in my life and I wanted some pause and clarity. And I actually, years back, I had take a yoga class and then I started doing core barre yoga as well. So I realized that it really has a big impact on me. And then I just try to be more disciplined and try to take out time, if not every day, maybe every two days, but I would say it's more of a recent phenomena. It does require a lot of discipline. Earlier you start, the better it is because you're not going to get it right away. It takes a lot of discipline and commitment to incorporate these. And you won't be able to do it all the time, but at least starting that and trying to incorporate day to day life is a good start. [00:21:26] Lindsey Dinneen: Yeah, absolutely. I found personally that starting my day with a much more intentional routine that includes things like meditation and those kinds of mindfulness practices makes a huge difference in how I feel throughout the whole day and the week in general. So, and that's a more recent development for me too. So it's one of those interesting things about how that evolves over time. So I love that. Thank you for sharing about your own journey. All right, and then how do you wish to be remembered after you leave this world? [00:21:59] Nidhi Oberoi: As I said purpose is my core value, big on impact. So I just want to leave the world a little bit better and do my bit. And whether it's working on things, like working on technologies and providing access to health care to patients, probably globally. So it's just continuing to make an impact in the healthcare space and leaving the world a little bit better than I inherited it. [00:22:27] Lindsey Dinneen: Yes. Excellent. And final question, what is one thing that makes you smile every time you see or think about it? [00:22:37] Nidhi Oberoi: Yeah. There are so many different things. As you start meditating or focusing on mindfulness, it's the small things in life that you start enjoying. Being in Minnesota, the good weather is difficult to come by. So sunshine really makes me happy. But yeah, I think being present makes you more joyful. You just start enjoying everything in life. The other thing I would say is just simple acts of kindness. People helping other people is also something that just moves me and touches me. [00:23:11] Lindsey Dinneen: Yeah, of course. I'm really curious. Okay, so I said final question, but then I have a follow up. So when you said being present helps bring you joy, could you share a little bit more about what you mean by that? [00:23:24] Nidhi Oberoi: Yeah. So I think being present means that you are not thinking about your past and you're not thinking about your future. And so what that means is all you're focusing is what's in the now, and I'm going to start speaking the language of someone who teaches yoga or meditation, but being present really is you're not in the past. You're not in the future. You're just enjoying your day, the moment, as it comes by, it's as simple as that. You're centered. You're aligned with yourself and you just focus on what's in your control. You don't dwell on things either of the past or in the future. So I think that's a very, that's a beautiful moment to be in. [00:24:11] Lindsey Dinneen: Yes, I couldn't agree more. Well, thank you for sharing a little bit more about that. I really appreciate it. And thank you so much for your time today. This has been such a great conversation. I've loved learning about you, and I'm so excited about your career future, especially with your goal of starting your own company at some point. So I will be cheering you on for that whole process. I know that's no small undertaking. But in the meantime, I just want to say thanks again for your time, and thank you so much for working hard to change lives for a better world. [00:24:45] Nidhi Oberoi: Well, thank you so much. Thank you for the opportunity. It's been so fun chatting with you. You're joyful. [00:24:52] Lindsey Dinneen: Thank you. Well, excellent. We are so honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational, and safe environment. So thank you so much for choosing that charity to support. Thank you also so much to our listeners for tuning in. And if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two. And we'll catch you next time. [00:25:30] 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 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.

Paris Panayiotopoulos, Senior Managing Director at Blackstone Life Sciences, shares how the firm's broad life sciences strategy has been advancing innovation across the life sciences ecosystem in three key ways: late-stage product financing (Collaboration) and new company creation (Ownership), and non-dilutive financing (Credit and Royalties). He explains how Blackstone is bridging the innovation funding gap through high-conviction partnerships with larger BioPharma and MedTech companies, and targeted investment in late-stage trials.

What turns a brilliant idea into a market-ready medical device? Jennifer Palinchik, CEO of SageMar Medical, has spent over two decades guiding innovators through that exact journey. In this episode, Jennifer shares the critical factors that determine whether your device gets adopted—or ends up on the shelf. From navigating regulatory hurdles and defining market value to aligning R&D with commercialization from day one, Jennifer reveals the strategic playbook that every MedTech founder should know. We also explore trends like AI, mixed reality, and the growing role of M&A in accelerating innovation. If you're building in healthtech, Jennifer's insights will help you avoid costly missteps and build a business that truly scales.

In this episode of Medsider Radio, we sat down with Maulik Nanavaty, CEO of Anumana. Anumana, an AI-driven health technology company focused on cardiovascular care, is taking a pragmatic approach to scaling AI in medicine.Maulik is a seasoned healthcare executive with over 30 years of global experience in the medical device industry. He spent 18 years at Boston Scientific, where he led its $1B+ Neuromodulation division and served as President of Boston Scientific Japan. Prior to that, he held leadership positions at Baxter. Known for driving innovation in implantable and artificial intelligence (AI)-powered technologies, Maulik also serves on the board of Rani Therapeutics.In this interview, Maulik shares why building a strong risk-benefit case and designing around real-world clinician needs are key to adoption. With data from over 20 million patients and a focus on transparency, Anumana is reshaping how AI reaches the point of care.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Maulik Nanavaty.

Ron Richard, author and founder of BLD Consulting, joins hosts Michael Roberts and Scott Zeitzer to discuss what it's like to launch new medtech products in the current landscape. With over 35 years of experience in medtech business strategy, Ron shares his insights on how companies can adapt their strategies to the changing times. Hosted on Acast. See acast.com/privacy for more information.

In this episode of The Med-Tech Talent Lab, I sat down with Caleb Polley, founder & CEO of Cubby Beds, to talk about how he's bringing empathy and engineering together to create safer, smarter sleep solutions for kids with special needs.We covered:The personal journey that sparked the Cubby Beds missionHow to build products that truly serve underrepresented populationsBalancing speed, scale, and regulatory rigor as a MedTech startupWhat it means to lead with empathy and how it shapes hiring and cultureKey lessons for any founder building mission-first, market-ready solutionsIf you're a founder, product leader, or operator in MedTech (or beyond) looking for perspective on how to build with both precision and purpose Caleb delivers the blueprint.Caleb Polley on LinkedIn: https://www.linkedin.com/in/calebpolley/Cubby Beds on the web: https://cubbybeds.com/

In this insightful episode, Mike Drues joins host Etienne Nichols to dissect the FDA's most frequently cited compliance issues, challenging the notion that many are strictly "pre-market" concerns. They delve into the nuances of software changes, design creep, and off-label marketing, providing a critical look at how companies can avoid common pitfalls. This discussion is vital for MedTech professionals seeking to understand the true nature of FDA expectations and build more robust quality systems.Timestamps00:04 – Introduction to common FDA compliance issues02:02 – Discussion on FDA's policy of not naming individuals05:45 – Mike Drues challenges the "pre-market" classification of common issues09:20 – Documentation requirements for different device classes11:35 – Mike's take on the most common FDA issues (beyond the presented three)15:40 – Root causes of common compliance problems and industry responsibility20:00 – The role of regulation and FDA's responsibility in clarity27:05 – Deep dive into design change and design creep31:40 – Software changes and the "bug fix" mentality35:45 – Marketing beyond authorized intended use with a real-world example41:00 – Key takeaways and proactive compliance strategiesStandout Quotes"If the regulation makes sense, we shouldn't need it. If the regulation doesn't make sense, we shouldn't have it." — Mike Drues. This quote encapsulates Mike's philosophy on regulatory compliance, emphasizing that true professionalism means understanding inherent needs rather than just following rules."You have a piece of software, you have a bug, you fix the bug… Is your job done? Absolutely not." — Mike Drues. This highlights a critical oversight in software development within MedTech, stressing the importance of holistic post-fix validation to prevent unintended consequences.Top TakeawaysRegulatory Misclassification: Many issues labeled by the FDA as "pre-market" (e.g., marketing beyond intended use, design creep) are fundamentally post-market compliance challenges. This distinction is crucial for companies to allocate resources effectively.Beyond Administrative Review: While administrative incompleteness accounts for a significant portion of 510(k) rejections (around 38%), the scientific and substantial equivalence reviews are major hurdles, with approximately 75% of 510(k)s rejected initially, primarily due to lack of substantial equivalence (85% of those rejections).Top Post-Market Violations: Historically, the most common reasons for FDA 483s and Warning Letters relate to CAPAs (12.5%), design controls (12.5%), and complaint handling (10.5%), collectively accounting for roughly 35% of all post-market issues. Companies should prioritize these areas.Software Change Management: Fixing a software bug is only the first step; a holistic review is essential to ensure no new problems are introduced and the device's safety, efficacy, and usability remain uncompromised.Intentionality vs. Compliance: Marketing a device beyond its authorized intended use, even if the device functionally performs beyond its cleared claims, carries significant regulatory and product liability risks. Companies should seek appropriate clearance for expanded claims rather than relying on off-label promotion.References & LinksEtienne Nichols' LinkedInGreenlight GuruCall to...

Send us a textGenerative AI is transforming the way clinicians interact with technology. In this episode, Dr. Holly Urban, VP of Business Development at Wolters Kluwer, joins John Driscoll to discuss how AI, ambient listening tools, and trusted medical content like UpToDate are improving clinical workflows, easing documentation burdens, and making healthcare delivery more precise, efficient, and human-centered.

In this episode of the Healthy, Wealthy and Smart podcast, host Karen Litzy welcomes Elizabeth Chabe, MBA, MS, CEO of High Touch Group and author of "The Giant's Ladder, The Science Professional's Blueprint for Marketing Success." Elizabeth shares her expertise in marketing within the science and technology sectors, particularly focusing on biotech and MedTech. She discusses the challenges faced by innovators in getting their ideas noticed and provides insights on how to market groundbreaking work effectively. Listeners will gain valuable strategies for building brand awareness and achieving market traction, making this episode a must-listen for health and wellness professionals looking to amplify their impact. Join Tara and Elizabeth as they explore the intersection of science, storytelling, and strategy in marketing. Time Stamps:  [00:01:43] Marketing strategies for science professionals. [00:04:33] CRISPR and corporate strategy. [00:10:58] Fractional wet lab space. [00:12:08] Storytelling in scientific marketing. [00:15:50] Founders and product-market fit. [00:19:24] Selling scientific products effectively. [00:25:20] Business strategy vs. marketing gloss. [00:29:43] Science marketing for founders. [00:34:40] Marketing strategies for researchers. [00:38:04] Philanthropic support for dog rescue. [00:39:19] Importance of mission in business. More About Elizabeth:  ELIZABETH CHABE (MBA, MS) is an author, entrepreneur, and recognized strategic marketing consultant for science, engineering, and technology organizations. Her work has been featured in The New York Times, Popular Science, Entrepreneur, CNBC, Composites World, and 360Dx, among others.   As the founder and CEO of High Touch Group, Elizabeth oversees a team that develops marketing and PR strategies for advanced science, engineering, and technology organizations. Through High Touch Group's holistic, comprehensive marketing services, clients generate more leads, drive revenue, and elevate their brands into the global B2B space.  Her work as a strategic consultant has been instrumental to biotechnology, energy, advanced materials, advanced manufacturing, robotics, and automation companies.  Since her first business venture at the age of nine, Elizabeth has built and overseen countless successful research programs and marketing teams. As the former senior manager of digital and strategic marketing at the Jackson Laboratory (JAX), she developed the marketing strategies for its mouse model portfolio, model generation (CRISPR), and in vivo contract research services.  Prior to joining JAX, she oversaw global communications for the Advanced Structures and Composites Center in Maine. There, she managed projects including the center's offshore wind research program, the largest research and R&D program in Maine's history.  Since 2018, Elizabeth has been a governor-appointed director of the Maine Venture Fund.  An inveterate traveler, she splits her time between the US and developing world communities. She currently resides in Mexico with her husband and rescue dogs.  Resources from this Episode: July 17th Jane Q&A Webinar High Touch Group Elizabeth's Website Elizabeth on LinkedIn Giant's Ladder Book   Jane Sponsorship Information: Book a one-on-one demo here Mention the code LITZY1MO for a free month Follow Dr. Karen Litzy on Social Media: Karen's Twitter Karen's Instagram Karen's LinkedIn Subscribe to Healthy, Wealthy & Smart: YouTube Website Apple Podcast Spotify SoundCloud Stitcher iHeart Radio

This panel was recorded June 26, 2025.⁠⁠⁠⁠ We hope you'll join us live in the future to ask your own questions and participate in the attendee chat! See similar events on demand and read other free MedTech resources at RQMplus.com.SummaryHear leading neurology innovators discuss how to navigate complex regulatory pathways, accelerate approvals, and reduce risk in bringing groundbreaking neurological devices to market.LinkedIn panelist and moderator profiles 

  Background: From IT in India to MedTech in Norway  You have a pretty fascinating background – you studied computer applications/IT back in India and now you're a Quality/Regulatory Manager in the Norwegian medtech scene. Can you walk us through that journey? How did you go from an IT degree in India to working with medical device regulations in Norway? (What prompted the move and career change?)  What were the biggest challenges when you switched into the medical devices field? For example, was there a steep learning curve with all the medical and regulatory jargon?  And conversely, do you think your IT background gives you any unique advantages in QARA? (Maybe in handling technical documentation or bringing a fresh perspective?)  Day-to-Day as a QARA Manager   Let's talk about what a QARA Manager actually does. What does a typical day or week look like for you as a Quality and Regulatory Affairs Manager? (For instance, are you reviewing a lot of documents, meeting with engineers, training colleagues, dealing with audits… all of the above?)  It would be great if you could mention some of the tools or software you use regularly. Are there specific QMS (Quality Management System) tools, document control systems, or even simple spreadsheets that are part of your daily routine?  We often hear that QA/RA folks are like the “internal police” in a company – some colleagues think you just spend days reading boring regulations and chasing them to follow rules (laughs). How true or untrue is that stereotype? How would you describe the role to someone who thinks it might be dry or overly bureaucratic?  On that note, an article I read actually said quality and regulatory roles are among the most dynamic and diverse in a company. You have to know a bit of everything – the tech, the laws, writing skills, you name it. What parts of the QARA role do you find most challenging, and which parts are the most rewarding?  (For example, is it challenging that the scope is so broad – one moment you're deep in engineering specs, next moment you're updating a regulatory policy? And rewarding perhaps when a product finally gets approved or when you prevent a big issue?)  First MedTech Role at Hy5Pro AS  Let's dive into your work experiences. Your first QARA role in Norway was at Hy5Pro AS, a startup developing a pretty cool product – a hydraulic prosthetic hand for amputees. What was it like stepping into Quality/Regulatory at a company making robotic hands?  (Feel free to explain what Hy5Pro's product was and your role there, e.g. implementing the quality system, getting certifications, etc.)  Do you have any memorable anecdotes from Hy5Pro? Perhaps a big challenge you faced early on or a funny incident while working on the prosthetic hand project. For instance, a lot of startups at that stage are trying to get their first ISO 13485 certification or pass initial regulatory hurdles – any story around that?  (e.g. “the day the auditors came for ISO certification” or a time something went wrong and how the team fixed it – anything that was a learning moment for you.)  Leading QARA at RemovAid AS   After Hy5, you moved on to RemovAid AS, which is another fascinating company – they created a device for removing contraceptive implants (a small gadget to help doctors remove those under-the-skin birth control implants). And I believe you were Head of Quality Assurance & Regulatory Compliance there. What were your main responsibilities at RemovAid, and how did it differ from your previous role?  RemovAid's product is a Class IIa medical device and was CE-marked under the new EU Medical Device Regulation. That sounds like a huge regulatory achievement. Can you share a proud moment from your time at RemovAid? For example, leading the company to ISO 13485 quality certification, or getting that CE approval, or the first time the device was manufactured at scale.  (We saw on LinkedIn you celebrated the first RemovAid device coming off a high-volume production line – feel free to tell that story!)  On the flipside, any tough or funny moments while at RemovAid? Perhaps juggling multiple roles in a small startup, or an unexpected problem that popped up (like a quirky product test failure or a documentation marathon just before a deadline)?  RemovAid is in women's health tech. Did working on a product aimed at female healthcare bring any special perspective or motivation for you? (Given it's about making contraceptive care easier – that's quite impactful.)  Consulting Experience at LINK Medical   Now, currently you're working at LINK Medical as a Medical Device Manager in their Quality/Regulatory team. So you went from being in-house at startups to a consulting role where you support multiple companies. What has that transition been like? How is life as a consultant different from working within a single company?  I imagine as a consultant you get to see a variety of projects – different devices, different teams – which can be exciting. Can you share any interesting experiences from your consulting work so far? Maybe an example of a cool project you helped on, or a common mistake you see companies making with QARA that you help fix, or even a humorous experience of jumping into a new company's project mid-stream.  Also, how do you manage your time and sanity when juggling multiple clients or projects? That sounds challenging – any personal tricks you've learned for staying organized when everyone needs your expertise at once? (laughs – “the consultant life”)*  Diversity and International Career Insights   I'd like to touch on diversity and your international experience. You're a woman in the medtech industry and you've built your career across two countries and cultures. Have you faced any unique challenges as a woman working in medical devices and QARA? And what about being an international professional – any cultural adjustments or advantages you've noticed working in Norway compared to India?  The medtech industry, especially in leadership, still isn't very diverse – I read that less than a quarter of executive roles in medtech are held by women. How do you feel about the state of diversity in our field? Are things improving, and have you seen progress during your career?  What advice would you give to companies or teams to foster a more inclusive environment, especially in fields like quality and regulatory? (Since those teams often work with all departments, they can influence company culture too.)  Rapid-Fire Round   Host: Okay, Pardeep, to wrap up on a fun note, we have a rapid-fire round! I'll ask you a series of quick questions and you answer with the first thing that comes to mind. Ready? (brief pause) Go!  Question 1: What's one thing about your job that most people would be surprised to learn?  Question 2: What's the coolest medical device or gadget you've worked on or seen so far?  Question 3: Are you team coffee or tea? (What fuels your workdays?)  Question 4: Is there a quality/regulatory jargon or acronym you think is funny or confusing (and what does it actually mean)?  Question 5: If you weren't in QARA, what alternate career could you see yourself in?  Question 6: What's one Norwegian word or phrase you've picked up that you love to use? (Bonus: translate it for us!)*  Question 7: If your career journey were made into a movie title, what would it be? (Just for fun!)  (Guest gives rapid-fire answers with laughter and brief commentary.)  Advice and Closing   Now, before we sign off, I want to circle back to a more reflective note. What advice or words of inspiration do you have for junior professionals, students, or even folks thinking of switching careers into Quality and Regulatory in medtech? For someone listening who says, “This sounds interesting but also a bit overwhelming,” how can they prepare and what should they expect?  (For example, should they get familiar with certain regulations or take courses? Find a mentor? Be ready to continually learn? Share any practical tips.)  And maybe equally important, what should they not be scared of? People might think “Oh, I'm not a science or law expert, can I do this?” – any encouragement to help them overcome that hesitation?      Podcast Interview Questions for Pardeep Kaur (Reg compliance manager Oslo University Hospital)  Welcome & Setup  Can you briefly introduce yourself and describe your current role as a Quality & Regulatory Affairs Manager?  Career Journey  How did you go from earning a Computer Applications/IT degree in India to a QARA career in Norway?  What motivated you to switch into medical device regulations, and what were the biggest initial challenges?  In what ways has your IT background helped you excel in QARA?  Day-to-Day Responsibilities  What does a typical day or week look like for you as a QARA Manager?  Which tools or software (QMS systems, document controls, etc.) do you rely on most?  Is it true that QA/RA professionals are the “internal police”? How would you describe the role to someone who thinks it's all paperwork?  Which aspects of QARA do you find most challenging, and which are the most rewarding?  Hy5Pro AS Experience  What was it like implementing QARA at Hy5Pro, developing a hydraulic prosthetic hand?  Can you share a memorable “learning moment” or funny anecdote from your time there?  RemovAid AS Experience  At RemovAid, you led Quality & Regulatory for a Class IIa implant-removal device—what were your core responsibilities?  Describe a proud milestone (e.g., ISO 13485 certification or CE marking) and the story behind it.  Any unexpected or humorous challenges you overcame in that role?  How did working on a women's health product impact you personally?  LINK Medical Consulting  How has transitioning to a consulting role at LINK Medical differed from in-house QARA positions?  What's a standout project or recurring compliance issue you help clients solve?  How do you stay organized when juggling multiple clients and deadlines?  Diversity & International Insights  As a woman in medtech QARA, have you faced any unique challenges or opportunities?  What cultural adjustments did you experience moving from India to Norway?  How can medtech teams become more inclusive, especially in QA/RA?  Rapid-Fire Round  (Answer quickly with the first thing that comes to mind.)  One surprise fact about your job?  Coolest device or gadget you've worked on or seen?  Favorite (or funniest) QARA acronym—what does it mean?  Alternate career you might have chosen?  Norwegian word or phrase you love—translate it for us!  If your career were a movie title, what would it be?  Closing Advice  What practical steps should students or career-changers take to break into QARA?  What misconceptions shouldn't they be afraid of when considering this field?   

In this episode, Liz and Rachel dive into the interview with Sarah Keenan about commercial training. They discuss their thoughts on a competency model, how and why to certify (or not), and the benefits of developing a learning culture. The episode ends with a reflection how training starts with trust: without it, your training just won't be effective. In 2025, we're embarking on a MedDevice Training Journey: From clinical trials to standard of care. Join us all year long as we explore training at each stage of the product life cycle.Need help developing your commercial training? Contact us at training@cumbyconsulting.com.Related Resources:Sarah Keenan InterviewSubscribe to our newsletter to hear more about the journey from clinical trials to standard of care! Click here to subscribe! Connect with us on LinkedIn:   ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Cumby Consulting⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Rachel Medeiros⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Liz Cumby⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠About Cumby Consulting:   Cumby Consulting's team of professionals deliver innovative MedTech training services for physicians, sales representatives, teaching faculty, key opinion leaders and clinical development teams. Whether you need a complete training system developed to deliver revenue sooner or a discrete training program for a specific meeting, Cumby Consulting will deliver highly strategic, efficient programs with uncompromising standards of quality.

Edited June 6th, reloaded June 7th. Thursday, June 5th, MBN was On The Road to Delta Township, (SW Lansing metro) as IONETIX Invests $25.75M in Delta Township Facility, Creating 53 High-Tech Jobs and Advancing Lansing's MedTech Leadership Expansion includes new cyclotron, advanced isotope lab, and strengthens Lansing's position as a national MedTech innovation hub In this video remarks are shared by officials and leaders involved ahead of the ribbon cutting ceremony. Please bear with occasional wind noise on the video's audio. Lansing, Mich. (June 6, 2025) — Yesterday, IONETIX, a leader in advanced radiopharmaceutical technologies, is investing $25.75 million to expand its Delta Township facility. The project will add a second cyclotron, and an advanced isotope processing laboratory. The expansion is expected to create 53 high-tech jobs and further accelerate innovation in life sciences and nuclear medicine manufacturing. “IONETIX's expansion is creating high-skill, high-value jobs and elevating the Lansing Region within the global medical technology landscape,” said Bob Trezise, president and CEO of the Lansing Economic Area Partnership (LEAP). “LEAP is proud to support this project and the ecosystem of innovative MedTech companies making our region a destination for biomedical research and economic opportunity.” IONETIX marked the milestone with a community event at its Delta Township facility, bringing together company leaders, regional partners, and officials from across the state. Speakers included representatives from IONETIX, LEAP, the Michigan Economic Development Corporation (MEDC), and Delta Township. Founded in 2009 from technology developed at the MIT Plasma Science and Fusion Center, IONETIX has pioneered the world's first commercial compact superconducting cyclotron, the ION-12SC, which is used to produce N-13 ammonia, one of the most accurate positron emission tomography (PET) imaging agents for detecting coronary artery disease (CAD). The company has also expanded its focus to targeted alpha therapy (TAT), an emerging cancer treatment utilizing high-energy alpha particles to target cancer cells while preserving healthy tissue. "Delta Township and the Lansing region offer the ideal environment for IONETIX's continued growth. The area's highly skilled workforce, robust infrastructure, and strong spirit of public-private collaboration make it the perfect location for our expansion,” said Kevin J. Cameron, Chief Executive Officer of IONETIX. “We are honored to invest in this community and proud that it is in the forefront of creating diagnostic and therapeutic innovations.” This expansion aligns with IONETIX's broader strategy to grow its radiopharmaceutical manufacturing network, advance commercialization of new therapies, and reinforce Michigan's leadership in life sciences and medical technology innovation. The State of Michigan, through the Michigan Business Development Program, awarded IONETIX $750,000 in incentives to support this expansion, ensuring a strong pipeline of skilled talent and continued innovation in the region. We are thrilled with the company's commitment to Michigan and the Lansing community by investing over $25 million to accelerate the efforts to one day cure cancer,” said Matt McCauley, Senior Vice President for Regional Development at the MEDC. "Team Michigan welcomes IONETIX Corporation's expansion, furthering Michigan's leadership in the life sciences and medical technology industries. We applaud the company's vision to Make it in Michigan. » Visit MBN website: www.michiganbusinessnetwork.com/ » Subscribe to MBN's YouTube: www.youtube.com/channel/UCqNX… » Like MBN: www.facebook.com/mibiznetwork » Follow MBN: twitter.com/MIBizNetwork/ » MBN Instagram: www.instagram.com/mibiznetwork/

Thought leader Julio G. Martinez-Clark shares how his company in helping to bring medical innovation to the market sooner by conducting clinic trials in Latin America. About Julio: Julio G. Martinez-Clark stands at the forefront of clinical research transformation as the Ambassador of IAOCR/GCSA in the Americas and CEO of bioaccess®, where he bridges global quality standards with the world's growing MedTech, BioPharma, and Radiopharmaceutical ecosystems. With over two decades of cross-industry leadership spanning healthcare, telecommunications, and venture capital, Martinez-Clark has become the trusted partner for 100+ companies seeking accelerated regulatory approvals and cost-effective clinical trials worldwide. His unique fusion of technical expertise from Johns Hopkins Hospital infrastructure projects, regulatory acumen honed through UNESCO-aligned accreditations, and operational mastery of diverse global clinical trial landscapes positions him as the definitive authority on risk-mitigated medical innovation in emerging markets. Resources: Products discussed in the podcast: ReGelTec: https://regeltec.com/regeltec-chooses-colombia-bioacce-for-first-in-human-clinical-trial-of-hydrafil-system/   Spine Stabilization Technologies (SST): https://thespinemarketgroup.com/spinal-stabilization-technologies-ltd-announces-start-of-lopain-2-clinical-trial-in-south-america-for-lumbar-degenerative-disc-disease/   bioaccessla.com   Show sponsor:  The Cox 8 Table by Haven Medical

A new micro-credential course to encourage sustainability in the medtech, pharma and public sector in Ireland has been launched at University of Galway. The Green Labs initiative has been spearheaded since 2019 by Dr Una FitzGerald, Associate Professor of Biomedical Engineering in the School of Engineering and a Principal Investigator within CÚRAM, the Research Ireland Centre for Medical Devices. Green Labs develop medtech sustainability course The new 10-week microcredential programme is aimed at Ireland's extensive laboratory industry, including medtech and pharma, healthcare and science and the research sector and builds on the success and impact of the Green Labs initiative, which aims to reduce the environmental impact of laboratory practices. Dr Una FitzGerald said: "Once I took on board the considerable contribution that sustainable lab practices can make to global efforts to reduce GHGs and different kinds of waste, I felt compelled to act, because I supervise and teach many different cohorts of students. I feel I have a duty to do all possible to mitigate the climate and biodiversity crisis and feel fortunate that I am in a position to help. "As Ireland's medtech and pharma sectors continue to grow, so too does the responsibility to operate in an environmentally sustainable fashion. Laboratory testing is a crucial part of operations in these organisations, as well as for hospital and environmental testing - just think of how many lab tests are require to diagnose disease or to prove that the water you are drinking is safe. Medical device manufacturers also need lab tests to prove that implantable devices are sterile, and pharma companies use labs characterise the properties of drugs." The green labs journey commenced in 2019 with CÚRAM becoming the first laboratory in Europe certified as 'Green' by American non-profit, My Green Lab. Meeting this standard required raising awareness of the impact of lab work on the environment and prompted efforts to reduce plastic waste, energy and water usage and adopt green principles of synthetic and analytic chemistry. One fact learned was that a single ultra-low temperature freezer, used to store lab samples, uses as much energy as the average household. In 2020, Dr FitzGerald developed a course module for postgraduates on green lab principles and practice, which more than 170 students have taken to date, including online at universities in England, Scotland, Germany and Denmark. On Earth Day in 2022, Irish Green Labs (IGL) was launched by Dr Fitzgerald, in collaboration with Sustainable Energy Association of Ireland and Dublin City University to promote sustainable methods within public and private laboratories on the whole island of Ireland. The new online microcredential programme Green Labs Principles and Practice, will go further to address the lack of awareness of the impact that lab practices and behaviours have on the environment. Employees in corporate and public sector are being targeted through this course and the first 20 places are funded through Springboard. The first students enrol in September. Microcredential courses are short and accredited to meet the demands of learners, enterprise and organisations, created by Irish Universities Association (IUA) partner universities in consultation with industry and enterprise, under the MicroCreds project. Green Labs Principles and Practice will allow employees to examine how the organisation of, and practices in, scientific laboratories can be reformed to reduce their environmental footprint and be established on a more sustainable basis. The Irish Green Labs network is run on a voluntary basis, supporting more than 37 organisations within the public and private sectors, including all the higher education institutes, the Environmental Protection Agency, 10 hospitals and seven companies. Dr Fitzgerald's work in this area ultimately led to inclusion of sustainable lab practices in Taighde Eireann/Research Ireland's Climate...

Jessica Richter is a medtech executive and a board member with MedtechWOMEN. Jessica shares her inspiring journey from B2B sales to becoming a leader in the medtech industry, including overseeing a wide range of vital functions such as clinical trial strategy, regulatory affairs, and market access. Jessica provides insightful advice on overcoming common industry challenges, and underscores the value of quality systems, expert team-building, and fostering a supportive network for women through MedtechWOMEN.   Guest links: https://www.linkedin.com/in/jessica-richter-5aa43517/ | https://medtechwomen.org/ Charity supported: Save the Children Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 059 - Jessica Richter  [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I'm excited to introduce you to my guest, Jessica Richter. Jessica is the Executive Vice President and General Manager at Veranex, a global provider of end-to-end solutions that accelerate MedTech innovation through deep expertise and integrated resources. As the leader of Veranex's contract research organization and consulting services business unit, she oversees clinical trial strategy and execution, clinical data services, regulatory affairs, quality and compliance, market access and reimbursement. She also manages operations, client engagement, business development and performance tracking. A seasoned leader in medical devices and diagnostics, Jessica has extensive experience in software as a medical device, surgical innovation, oncology, aesthetics, cardiology and gastroenterology. Her tenure at Medtronic and Becton Dickinson shaped her expertise in commercialization, sales strategy, physician education, patient advocacy, and change management. Beyond her current role, Jessica serves on the boards of medtech, women and UCLA's technology development group. She actively advises startups, accelerators, and universities, including medtech innovator UC Berkeley's Master of Translational Medicine Program, the Mayo Clinic's Executive Steering Committee for the Surgical Innovation Summit, and UCLA BioDesign.   Thank you so much for being here, Jessica. I'm so excited to speak with you. [00:02:15] Jessica Richter: Likewise, Lindsey, thank you so much for having me. [00:02:18] Lindsey Dinneen: Of course. Well, I'd love if you wouldn't mind sharing a little bit about yourself and your background and what led you to medtech. [00:02:26] Jessica Richter: Awesome. Yeah, happy to. So, I was born and raised in California. I am the youngest of three girls and my entire family is really in the healthcare delivery field. So both my grandfathers were surgeons. My mother is a nurse. Both my sisters are clinical psychologists. And so when I went to school, I had aspirations at one point to get into medicine, and then through a really challenging organic chemistry class, kind of started to realize that maybe the practice of medicine wasn't where I belonged. And so I initially graduated from Berkeley, had my sights set on potentially doing something in communications, and started off in business to business sales in the telecom industry. So as far from medtech as maybe one could think. Had some experience with software, this is when Blackberries were a thing, if you remember those. And then a friend of mine was a recruiter and reached out and said, "Hey, I, I know that you're into medical and into medicine, and that was something you were interested in. Have you ever considered a career in medical device sales?" And frankly I didn't even know that that existed. I mean, this was 20 years ago, so this was before, you know, internet and all of those things existed, obviously, but it wasn't as pervasive as it is now. And so I wasn't even aware that these jobs existed. The fact that you could be working on the delivery of care but not be a healthcare provider was an eyeopening moment. And so I got in and started actually working at a surgical company called Deval. It's part of CR Bard, which is now part of Becton Dickinson, and I cut my teeth in medical device sales. And then I went on to work in a commercial role within other companies Given Imaging, Covidian, Medtronic. I ascended to sales leadership, working with key opinion leaders, working on the patient advocacy side. And then about eight years ago, I had the opportunity through an organization that we'll talk a little bit more about, called MedtechWOMEN, that I was involved in to learn about a consultancy that was looking for a head of business development marketing. It was a small group called Experian Group. I joined them and then within nine months was promoted to Chief Operating Officer, which was a position that I absolutely loved because we were working on the pre-commercial side of things and regulatory quality systems, clinical trials. And I had always had experience in the post commercial side. So eyes open to what happens, everything leading up to commercial. And I got a masterclass from my colleagues there, learning so much about what happens again, pre-commercial. But then one of the other things that came out very quickly is I've always been someone who loves operational efficiency. And I know that's not sexy or cool, but I just like seeing something that isn't working optimally and get it working optimally is something that brings joy. So I had the opportunity to do that within Experian Group, and then really help the organization, which was already very successful, go from a very successful kind of local consultancy to a much larger, broader group with a broader footprint, more global client base. And then we were acquired by the firm that I currently work with called Veranex, and that really exploded capabilities of what was a 50% consultancy to now over a thousand people with a much broader global reach in the US, in Europe, and in India. [00:05:36] Lindsey Dinneen: Wow. That is incredible. Well, first of all, thank you for sharing your story and your background and all the amazing things that led you to where you are right now. That's incredible. So many questions, in a good way. But let's dive in a little bit about, yeah, so, so tell us a little bit more about your role right now, and what are you excited about as this consultancy continues to grow and new opportunities arise. What's on the future for you? [00:06:02] Jessica Richter: So now I lead one of three business units here at Veranex. So I lead our CRO and Consulting Services Business Unit, and that encompasses regulatory, quality, and clinical, as well as commercial strategy, market access reimbursement, things like coding, coverage, payment. So we help mid-size, early stage, and some of the largest strategic medtech companies, as well as some biopharma as well with companion diagnostics, navigate sometimes the tumultuous waters needed to bring a device from inception all the way through to commercialization. Veranex also has two other business units in preclinical as well as extensive design, development and engineering. So there's leaders in each of those capacities. And what we do on CRO and consulting services is really consultative. So we work with clients to develop strategies in all of these areas, and then we roll up our sleeves and work alongside them to make sure that those strategies are actually executable, so to help them along the way. And some of our clients have teams, so it's strategic and we're advisors. Other clients, if they're early, early, may not have extensive expertise or the ability to build out teams in that way. So we go in, or our team goes in, and really provides them that support along the entire continuum. It's interesting, just today, we have a client we've been working with for two years. They're in Switzerland, but they've been working with our US and global team. They just got news from FDA that they obtained FDA clearance. And I'll tell you, I think our team is as excited as theirs because, when you're in a company, it's all that you're living, breathing, doing. When you're consulting, you're a little bit at an arm's length. So when our clients achieve their results, and it's their work, but in concert with ours, the feeling of accomplishment really is just, it's one of those that's explosive. So we've celebrated that. We ring a bell. We'll share a lot, we'll do some marketing around it with this client. But it's really fun. That's the part that really drives not just me, but members of our team as to "How can we help more companies get more products to patients?" [00:07:58] Lindsey Dinneen: I love that. First of all, congratulations, that's exciting, and I'm thrilled for your clients and for you guys because it matters so much and what a great milestone. So that's wonderful. But yeah, so I'm curious, you've seen a lot of different sides to medtech and to the business side of things, and I'm curious what are some potential stumbling blocks that you have seen that companies, especially when they're perhaps a little bit younger or earlier on in the process, what are maybe one or two stumbling blocks that you see that you think, "You know what, hey, if we put a little bit of thought into this, we can overcome this very easily, but we need to be thinking about this from the start." [00:08:36] Jessica Richter: Okay. There's two things. One of them is gonna be a shameless plug, but I swear it's true, and that's quality. I think companies don't focus enough on quality systems 'cause it's just not the fun or sexy thing, but it's literally where we see companies struggle because they think about it too late. They do just in time. They think an EQMS is the answer, and it's not the only answer, it's a component. So quality would be the short answer. The longer answer is people. So what we see is oftentimes, people, especially in a cost constrained environment, which we are today, where fundraising is tough, people do need to be financially astute as far as what they're spending and how they're spending it. But sometimes you get more by spending a little bit more to get the right advice. So for example, if somebody is expert in engineering or expert in regulatory, excellent. Know where your expertise is not, and then supplement. So either hire a consultant or bring on an employee or have a member of your board that can advise them that way. More often than not, we see people trying to just kind of figure it out as they go, which isn't a bad strategy, but there are critical decisions and inflection points along the way. For example, if you're developing a clinical trial, thinking only about your regulatory strategy and not about your commercial goals or the claims you're going to make, you are gonna have to ultimately spend twice as much when you have to do secondary studies that you could have avoided by including that in endpoints. So there's little things like that along the way where if you don't know what you don't know, it's really difficult to see those hurdles. It's helpful to bring in people, even in an advisory capacity, to help you say, "Okay, these are the hurdles that you're gonna face." You're gonna have new hurdles that maybe that you won't know or people won't know, but it's really making sure that you surround yourself with experts in those key areas. [00:10:25] Lindsey Dinneen: Mm. That's great advice. Experts in those key areas. Well, speaking to the advisory point, I'd actually love to talk about your involvement with MedtechWOMEN, and tell us a little bit about that organization and how it serves women in this industry. [00:10:39] Jessica Richter: Absolutely. Thank you for asking. It's something that I could literally talk about for this entire podcast. So, I alluded to it earlier, but MedtechWOMEN, I got, and I say "roped in" lovingly, but I was introduced to this organization, gosh, maybe a decade ago now when I was at Covidian and then Medtronic, and a mentor of mine, Amy Belt Raimundo, was one of the founders of MedtechWOMEN. And she had mentioned to me, because there weren't a lot of female leaders within that section of my business at the time, so I was paired with her and it feels like kismet because she was this spark of like, this is what badass female leadership looks like. She knew her stuff, she was really focused on the issues. She made time and said yes anytime I had a question or wanted to meet. Our conversations were really meaningful and actionable. Sometimes we just talked as friends. It wasn't always so agenda based, but she introduced me to MedtechWOMEN and shared with me that there's this organization. It's all volunteers. It's kind of membership based and it's literally women getting together talking about the issues in our industry. And it wasn't as focused on things like work-life balance, which quite frankly is a challenge, no matter what your gender is. There are great forums for talking about work-life balance and how you prioritize your health and your mental wellbeing, and that is really, really important. But some of the events that I had gone to as far as women in leadership or women in medtech were really focused on those things and that wasn't what I wanted to talk about. I wanted to see incredible pioneers or trailblazers in our industry talking about the things that mattered in industry and sharing their perspectives. And that's exactly really the thesis of MedtechWOMEN. And so it was an organization founded over a decade ago. It started really as just an annual event, this MedtechVISION event, where we brought women together on a podium talking about the issues impacting healthcare today. It evolved. So after a couple of years and a couple of different topics, what we started to see is that there was a real thirst in the community that we had beyond just that individual or that one time a year we got together for the event. And so we developed a kind of MedtechWOMEN 2.0. We brought on an Executive Director. And we essentially launched a much, much grander vision of what MedtechWOMEN was. So it included membership. It included mentorship, so formal pairings. We created a board of directory, kind of a pathway to get to more women on boards. We also have local events, networking events, virtual events in partnership with our sister organizations like MedTech Color and Diversity by Doing. And then of course we still have our annual event. And then just this past month we actually brought on a new executive director. Her name is Yvonne Bokelman. She is a longtime industry veteran, tremendous leader in medtech, and someone who's really passionate about the organization, the mission, the vision. So we're excited to see what she will do in her role here. [00:13:38] Lindsey Dinneen: Yeah. That's incredible. Thank you so much for sharing a little bit about the organization and its history and who it is serving, and it really resonated because I agree with you that there's wonderful platforms for being able to talk about some of the. Some of the topics that tend to come up quite a bit for women, especially women leaders, and I love the fact that you are fully acknowledging that those things are great as well, but that your focus is a little bit different. And so I'm curious, what are some interesting stories or things that have happened maybe unexpectedly from this network of incredible women supporting each other, learning from each other. Can you share a little bit that? [00:14:17] Jessica Richter: Oh yeah, absolutely. And I'll tell you, many of us that have been members for a long period of time will attest to the fact that job opportunities come via this network, learning opportunities, sales and business opportunities. I mean, we network in the same way that we would in any other conference or any other meeting, but deals certainly have gotten done within and at MedtechWOMEN and MedtechVISION events. But most importantly, and one of the things that I always tout, is that MedtechWOMEN is a sisterhood that will take that call. And what I mean by that is if you have a question, if you need to phone a friend-- going back to what we were talking about earlier of that network of you don't know what you don't know, but somebody probably does-- within MedtechWOMEN, someone definitely does. And so what we encourage our members and our mentors and anyone that's a part of the organization to do is reach forward and reach back. And so when I say take that call, if someone calls-- and I just had literally three conversations in the last three weeks-- with more junior people looking for career advice or wanting to have a question about regulatory or their thinking about a decision point in their job, and what should they do? I always take that call and, you know, we're all busy. We all have things to do, but that 30 minute conversation can have a really big difference. And I know for me, likewise, when I have a question, when I'm coming up against something where it's helpful to have a thought partner, sometimes you want that outside of your own company, or outside of your boss, or outside of your team. And so the MedtechWOMEN Network is incredibly powerful and very supportive. And in my experience, and I've tried it both ways, we will always take that call. [00:15:53] Lindsey Dinneen: Oh wow. That's incredible. So, okay, so mentorship and leadership is obviously a key component of your life, something that you're passionate about. From your own experience as a woman in this industry, are there any things that come to mind that you would say, just pieces of advice-- let's say for other women who might be younger in their career and they're looking to grow, they're looking to become leaders, they're looking to become maybe thought leaders, or own their own company, things like that-- what are some things that you might suggest to them from your own experience would be helpful? [00:16:27] Jessica Richter: Oh yeah. It's, it's a great question, Lindsey, because there's a lot of things. I wish we could just mind share. First and foremost, I would tell women to go for it. I think sometimes we self-sabotage or hold ourselves back if we don't have all of the information or feel like we're a hundred percent qualified. And there's been tons of studies that demonstrate that. So first and foremost, go for it. I had this conversation with one of my mentees who was taking on a new role and I said, "It's okay that you're feeling this way or that way. Do it and do it scared." Like it's okay to not feel like you have all of the confidence, right? And it doesn't mean fake it till you make it, although there's a little bit of that too. But I would say don't let fear hold you back. So that would be the first piece of it. The other piece of it is make sure that you have, really, your own board, meaning advocates, mentors, coaches, thought partners, people that you can reach out to and rely upon. And that has to work both ways. I will tell you, I have learned as much from mentees as I have learned from mentors. And so recognizing that knowledge is shared both ways, no matter what your seniority is. For people that are junior, they have their on the pulse of things that I'm not as privy to, and sometimes I feel, feel that even more strongly. Likewise for people that have been in this industry 40, 50 years, they have institutional knowledge that I only wish that I had. And so, being at this midpoint in my career, I'm sandwiched between both and really appreciate, so I would implore people that are hoping and wanting to pursue leadership, go for it. [00:18:00] Lindsey Dinneen: Yeah. Thank you for that. I, I love that advice. I really appreciate it. So, you have had such an interesting career and going from communication and sales, and then to this new role and Chief Operating Officer, all these cool things. For your own leadership style, what would you say are maybe one or two key things that you have found to be really helpful for you as a leader in the industry in the way that you approach the people that you lead? [00:18:30] Jessica Richter: Another great question, Lindsey. So I would say, well --first maybe I'll share some lessons learned 'cause I've made a ton of mistakes. So I think one of the things that I didn't appreciate early on as a leader that I definitely appreciate now, is that we all have our own lens, our view with which we take on and see the world, and that's the view in which, you know. And so as a leader, initially, my thought was, "Well, everyone kind of sees and feels it this way with their own flavor." That is not true. Everyone has their own view and that's really shaped by their family, their background, their culture, lots of different aspects. And so I think for me, some advice as a leader would be, be humble, take the time to really seek to understand, and then, even if you are heightening your communication, multiply that times three or four and then you're probably scratching the surface, 'cause people need to hear things different ways, multiple times. And it doesn't mean you need to micromanage or drill things down, but when you're leading an organization and bringing people along on a change, especially, it is important that people understand the why, the who, the what, the how come, and that they hear that re repeatedly so that they can understand it, they can buy into it, and that you're creating an environment to make sure that their questions are addressed. So, lesson learned kind of recommendation on the leadership piece. I think the other just piece of advice is that sometimes people aspire to leadership because they think it's glamorous or there's gonna be a lot of money there, or it looks like the leader doesn't have to do that much work, they're just delegating. What I would say is leadership is not glamorous. It's often thankless. It's super hard. I work tons of hours and I love the team that I work with, and so for me the why is that. But if you are not loving that, don't do that. There's plenty of opportunities that you can contribute meaningfully as an individual contributor or a principal or a subject matter expert, and that's great too. So know that if you want to lead people and be involved on that side of leadership, I welcome it. I think it's fantastic. I think there's a lot of people that get into it with a misconception of what it will look like. And I'll tell you it's worthwhile, but it's hard. [00:20:43] Lindsey Dinneen: Yeah, absolutely. Yeah, when you were talking about that it, the glamor side of things, I just remember so vividly and I, I joke about it because I think it's funny-- but very quickly, I used to own my own dance studio and I built that from the ground up. And people would say things to me like, "Oh my goodness. What you're doing, you're living your dream. That's amazing! Oh my gosh, how cool is that?" And inside, I'm like, "Ha, yeah, I mean, I spent the first two hours as the janitor this morning, and then the next two hours as the CEO. And then, you know..." And it's funny, but it's true, you wear a lot of hats as a leader and sometimes your job is literally getting down into the nitty gritty and cleaning up, and that's fine too. So I love that. [00:21:24] Jessica Richter: My quip is always from the janitor to the GM, like, "What needs to get done? There's no task too big or too small." And ultimately, I think that what you described in yourself, and I love that, is servant leadership, right? Like for me, I've always responded well, when a leader isn't above any task and doesn't ask for something that they themselves would not be willing or aren't willing to do along with their team member. And so again, that's, that's not the definition of leadership, but in my eyes, that's a definition of leadership that really resonates with me. [00:21:55] Lindsey Dinneen: Mm-hmm. I agree. Yeah. Well, speaking of stories and those kinds of fun things too, are there any that stand out to you, perhaps along your career or with MedtechWOMEN, or anything really, that just affirm to you that, "Hey, I am in the right industry at the right time, doing what I should be doing?" [00:22:14] Jessica Richter: Oh yes. So there's a couple of different specific examples. So firstly, one of the things that has happened as of late, and I feel like-- not to get too woo or California on you-- but these synchronicities where you'll be thinking about something or remembering something, and suddenly a project and people come together around it-- and again, I think that's part of the power of the network. But there was a friend of mine that I had run into at a conference, we were talking about a specific aspect of their business that was really needing some, some development, and it turned out that after that conversation, literally not a week later, I got a call from a prospective client that was interested in working in this specific space. We were able to connect them with this person that was in need of that exact thing. And it was with software and with AI and so a partnership was forged and now they are literally about to embark in this really explosive and announcement will be forthcoming about it. But there's so many examples of little nuances and synchronicities like that, that again, happen because of staying open, staying curious, that powerful network right place, right time. But I also think it's the magic of our industry. It's really small. People sometimes fail to appreciate because you have these large organizations that are hundreds of thousands of people, but the leaders within the organization are fairly connected and tight. It's really an interconnected ecosystem. So that's just kind of one broad example. There's also other really small examples of the power, I think, of MedtechWOMEN in just how it ignites and how it brings people together, especially across senior and junior roles. So when we do our networking events, we try to do them regionally, just to try to bring different people together. And you can have like the CEO of sometimes a large organization, like Lisa Earnhardt from Abbott is a member and an active participant. She often will come to events talking to someone who's their very first year in medtech. And when you see these examples of sponsors of ours really showing up and demonstrating a commitment to giving back, and you see these people that are junior that may not even know the seniority of the leader that they're speaking to, recognizing that we're all people at the end of the day, trying to really ideally propel healthcare and help patients in their journeys to health and wellness. And so when you see examples of those sparks and those little ignites, it reinforces why we're here, what it is we're doing, and really the power of the organization. [00:24:41] Lindsey Dinneen: Yeah! Well, I think that the more times that you get to see those connection points, and those synergies or whatever we wanna call them, I think that that does impact us in a way that goes, "Yeah, the work that I do matters and it's impacting people's lives and maybe in very different ways." So some of it is, yeah, that end user and that patient, and oh my goodness, what this device can do for them and their quality of life. And sometimes it's the person behind the invention and what does that journey look like for them personally and the impact on their own family and their life. So I love hearing about those connection points. [00:25:16] Jessica Richter: Well, and that's the joy of working also with, I mean, large strategics for sure, but the startup companies, oftentimes it's a physician and engineer. The physician is seeing the unmet need because of the patients coming into their clinic. They're feeling hopeless 'cause they can't address it, but also empowered because they know what to do. So those are the really fun, kind of feel good projects, especially because there is no one better equipped than a clinician, right, to say, "Okay, here's the gap." Engineers can help to design and develop, but oftentimes that's where the teams are sort of left in the lurch to say, "Okay, what do we do from here?" And so it is incredibly powerful to enable these innovators, no matter what their backgrounds are along that journey. And it's not a quick one as you know, being on the manufacturing side. It's not something that's quick or easy. It's not something that is a high success rate. And when it works, there is no better feeling. When you commercialize a device or when you get it through the FDA, that's just the start. When it's actually used in patients and you start to hear those patient advocates and those stories, and you expand indications and are able to help more patients, that's the thing that makes it worthwhile. And when the going gets tough, 'cause it does that, those are the stories, right, that really inspire us to continue. [00:26:33] Lindsey Dinneen: Yes, absolutely. Amen to that. So, okay, so I have so many thoughts swirling around, but I do want to pivot the conversation a little bit just for fun. So 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? [00:26:53] Jessica Richter: Oh, I love this question. I'll try to make it not about our industry 'cause it's something I've been working on a lot lately, and it's a testament to patience, which is something that I think we could all use more of, but I could definitely use more of. So we rescued a dog in Covid. She's a Doberman pit mix. Her name is Poppy and she's delightful. And she was severely neglected. So when we got her, we knew she was really shut down and that we would have to do work to bring her out of her shell. My husband and I don't have kids. We have a quiet home. I knew that we could take that on. And so while I won't say I am the expert, what I have done in the four years we've now had her, is extensively worked with her on the, what I would call the "Art of the Dog Walk." So we have learned how to really master exercise, training, and discipline as a way to show affection, 'cause for a dog that shut down like that, that's really what she needed to thrive. It was humbling and very educational for me. I've always been a huge animal lover. I used to volunteer when I had a lot more time with an animal rescue. And so I was able to parlay that and work with a trainer really on honing those skills so that Poppy could not just be social in the world, but be less shut down. So it would be so fun to share a masterclass on that 'cause I had so many reflections and learnings on patience. The art of going slow, the art of taking in the world, of just slowing that down, not being on my phone, right, being really present with her. And I sort of joke with my husband, I feel like now when I walk her-- I dunno if you've seen the movie "Avatar"-- but like we connect our avatars and we like go on into this world, and it's meditative. It's our morning practice and it's something that for me has been incredibly rewarding, and challenging, and a huge learning experience that, that I would love to share. [00:28:50] Lindsey Dinneen: Oh, that's wonderful. Oh my goodness. Yes. I am a huge dog lover, so anytime someone's telling me about their dog, it's just instant happiness. [00:28:59] Jessica Richter: Likewise. And for my, my favorite thing that it will always bring a smile to my face is the unlikely animal friends, like if you see like a squirrel a dog or a kookaburra or something, you're like, "Ahh!" [00:29:10] Lindsey Dinneen: It's so cute. It's precious. Yes. I love it. And to me it reinforces, "Hey, we can actually all get along if we try." I mean, I know it's a little different in the animal kingdom, but still, I still love that. Oh my goodness. Great. Well then, how do you wish to be remembered after you leave this world? [00:29:32] Jessica Richter: You know, legacy is something, that I think is important. It's funny, I've been working with my niece on her college essays and college admittance, and reflecting back to my views when I was 18 versus my views today in the world now. And even speaking to my mom about legacy, 'cause it's something, you know, she's approaching her eighties that she thinks more and more about. So it's conversations that we have a lot. I really would love to be remembered as an enabler, as someone who really enables those around me to be successful, to achieve more, to obtain what they want right to, to drive forward. I love being around creative people and innovators and people with really expansive imaginations, and I think my superpower is kind of capturing and enabling those things. So it would be great to be able to enable more people around me. And that's true with patients and healthcare and the clients that we support as well. You know, one of the things that has always been pointed out to me-- and again, my grandfather was a huge proponent of this-- is when things aren't going well in the world, you can focus on what's going wrong or you can look for the helpers. And so, as a surgeon, he was one of those helpers. And so I think he ingrained that in me very early on. And so I'd love to be remembered as someone who is a helpful enabler. [00:30:51] Lindsey Dinneen: Hmm. Yes. That's a beautiful legacy. I love that. [00:30:54] Jessica Richter: I am curious, Lindsey, I know this is like, you're the, you're the interviewer, but how would you like to be remembered? [00:31:02] Lindsey Dinneen: Oh, thank you for asking. First time! You know, there are so many things, so many things that I love doing for other people. But I really actually resonated with your idea of enabling. And I would say mine is very similar. And that is that I love helping people achieve their dreams. And that can look like lots of different things to lots of different people. So it's when I'm working with a company, it always started with one person's idea, right? All these big companies started off as this tiny little one person's idea that became something. And I think just helping that, those sparks, especially when maybe they're eager, but they're not quite ready. They're scared, they're nervous, they're whatever, and helping them see a clear path to achieving those dreams and goals is one of my favorite things. And whether that's just a personal, I wanna run a marathon, I don't even how to know how to get started, or whether it's, I have this great idea for a book, but I am concerned about, like, "Nobody will read it, no one will care." Well, that's not the point. Let's start somewhere. And so I think for me, it's about empowering people to live the life that they want to live and hope that they can live. That's what I would love to be remembered for. [00:32:16] Jessica Richter: Well, that's beautiful. I hope that via this and the other things that you're doing, it seems like you're already on that track. [00:32:22] Lindsey Dinneen: Well, thank you. I appreciate that. I really appreciate you asking me too. Thank you. Well, and then final question, and you've sort of perhaps alluded to this-- I'll see if it's different than your first time-- what is one thing that makes you smile every time you see or think about it? [00:32:37] Jessica Richter: Oh, well, definitely the unlikely animal pairings for sure. [00:32:41] Lindsey Dinneen: Yes. [00:32:42] Jessica Richter: Anytime with family. Family is super important to me. So anytime I can spend time with our family, that is for me, a smile doesn't go off of my face. And also kind of what you said, celebrating other people's wins. And I celebrate my own as well-- I think it's important that we do that-- but there is nothing like, it's a grin, like when someone on our team has an accomplishment, the grin is twice as big, right? Because you just, to see that reflected, that success, that attainment, that win reflected for the people that you work alongside, that brings a smile to my face every time. [00:33:20] Lindsey Dinneen: Yeah, nothing quite like it, and it's so powerful. Yeah, huh. Oh my goodness. Well, this has been an amazing conversation. I don't really want it to end, but I know we have other things we have to get to today, so I just wanna take some time to say thank you so very much for being here with me, Jessica. Thank you for sharing all about your incredible career so far and all the exciting things that are to come, and speaking to MedtechWOMEN and that incredible organization. So I'm really excited for our listeners who might not have been familiar with it to go check it out, lots of opportunity there. And gosh, I just wish you the most continued success as you work to change lives for a better world. [00:34:01] Jessica Richter: Thank you, Lindsey, for hosting and I would encourage anybody who's unfamiliar with MedtechWOMEN, if you're new to industry or if you've been here a while, there is a place for you within MedtechWOMEN. Membership is super low cost. It's $150 for standard membership a year, $75 for junior members. You can follow us on LinkedIn, but highly, highly encourage everyone to join the network. And thank you for the opportunity to share a little bit more about MedtechWOMEN today. [00:34:26] Lindsey Dinneen: Of course. We are so honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational, and safe environment. So thank you so much for choosing that charity to support. Thank you also to our listeners for tuning in, and if you're feeling as inspired as I am right now, I'd love it if you share this episode with a colleague or two, and we'll catch you next time. [00:34:57] Jessica Richter: Thanks, Lindsey. [00:34:59] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Dans cet épisode, j'ai rencontré Jonathan Benassaya, qui après avoir cofondé Deezer, se lance un nouveau défi de taille : sauver des vies avec SkinBeat, sa startup dédiée à la détection précoce du cancer de la peau par IA. De ses débuts dans la publicité intégrée aux jeux vidéo à son expérience fondatrice dans la musique en streaming, Jonathan partage les coulisses de la création de Deezer, les défis d'une ambition mondiale, et les raisons pour lesquelles la France n'a pas su faire émerger un « Spotify ».Mais ce podcast est aussi une histoire personnelle : celle d'un mélanome qui aurait pu lui coûter la vie. Ce choc devient le point de départ d'un nouveau combat entrepreneurial. Avec SkinBit, il développe une technologie de scan corporel capable de détecter les anomalies cutanées en quelques secondes, et espère doubler la capacité de diagnostic dermatologique aux États-Unis. SkinBit montre comment l'intelligence artificielle peut transformer la médecine préventive : en répliquant à l'échelle industrielle l'œil expert d'un dermatologue et en libérant du temps médical précieux. Cette approche bouscule le modèle de soin traditionnel avec un jumeau numérique et l'IA, qui promet une réduction des coûts de santé, une meilleure détection des cancers, et une amélioration des conditions de vie pour des millions de personnes.Une conversation lucide, inspirante et nécessaire sur l'entrepreneuriat, la santé, la tech et les choix stratégiques qui peuvent tout changer. Un épisode à ne pas manquer si vous vous intéressez à la MedTech, à l'innovation de rupture, et à l'impact réel des startups sur nos vies. Hébergé par Acast. Visitez acast.com/privacy pour plus d'informations.

Dr. Paul Hanona and Dr. Arturo Loaiza-Bonilla discuss how to safely and smartly integrate AI into the clinical workflow and tap its potential to improve patient-centered care, drug development, and access to clinical trials. TRANSCRIPT Dr. Paul Hanona: Hello, I'm Dr. Paul Hanona, your guest host of the ASCO Daily News Podcast today. I am a medical oncologist as well as a content creator @DoctorDiscover, and I'm delighted to be joined today by Dr. Arturo Loaiza-Bonilla, the chief of hematology and oncology at St. Luke's University Health Network. Dr. Bonilla is also the co-founder and chief medical officer at Massive Bio, an AI-driven platform that matches patients with clinical trials and novel therapies. Dr. Loaiza-Bonilla will share his unique perspective on the potential of artificial intelligence to advance precision oncology, especially through clinical trials and research, and other key advancements in AI that are transforming the oncology field. Our full disclosures are available in the transcript of the episode. Dr. Bonilla, it's great to be speaking with you today. Thanks for being here. Dr. Arturo Loaiza-Bonilla: Oh, thank you so much, Dr. Hanona. Paul, it's always great to have a conversation. Looking forward to a great one today. Dr. Paul Hanona: Absolutely. Let's just jump right into it. Let's talk about the way that we see AI being embedded in our clinical workflow as oncologists. What are some practical ways to use AI? Dr. Arturo Loaiza-Bonilla: To me, responsible AI integration in oncology is one of those that's focused on one principle to me, which is clinical purpose is first, instead of the algorithm or whatever technology we're going to be using. If we look at the best models in the world, they're really irrelevant unless we really solve a real day-to-day challenge, either when we're talking to patients in the clinic or in the infusion chair or making decision support. Currently, what I'm doing the most is focusing on solutions that are saving us time to be more productive and spend more time with our patients. So, for example, we're using ambient AI for appropriate documentation in real time with our patients. We're leveraging certain tools to assess for potential admission or readmission of patients who have certain conditions as well. And it's all about combining the listening of physicians like ourselves who are end users, those who create those algorithms, data scientists, and patient advocates, and even regulators, before they even write any single line of code. I felt that on my own, you know, entrepreneurial aspects, but I think it's an ethos that we should all follow. And I think that AI shouldn't be just bolted on later. We always have to look at workflows and try to look, for example, at clinical trial matching, which is something I'm very passionate about. We need to make sure that first, it's easier to access for patients, that oncologists like myself can go into the interface and be able to pull the data in real time when you really need it, and you don't get all this fatigue alerts. To me, that's the responsible way of doing so. Those are like the opportunities, right? So, the challenge is how we can make this happen in a meaningful way – we're just not reacting to like a black box suggestion or something that we have no idea why it came up to be. So, in terms of success – and I can tell you probably two stories of things that we know we're seeing successful – we all work closely with radiation oncologists, right? So, there are now these tools, for example, of automated contouring in radiation oncology, and some of these solutions were brought up in different meetings, including the last ASCO meeting. But overall, we know that transformer-based segmentation tools; transformer is just the specific architecture of the machine learning algorithm that has been able to dramatically reduce the time for colleagues to spend allotting targets for radiation oncology. So, comparing the target versus the normal tissue, which sometimes it takes many hours, now we can optimize things over 60%, sometimes even in minutes. So, this is not just responsible, but it's also an efficiency win, it's a precision win, and we're using it to adapt even mid-course in response to tumor shrinkage. Another success that I think is relevant is, for example, on the clinical trial matching side. We've been working on that and, you know, I don't want to preach to the choir here, but having the ability for us to structure data in real time using these tools, being able to extract information on biomarkers, and then show that multi-agentic AI is superior to what we call zero-shot or just throwing it into ChatGPT or any other algorithm, but using the same tools but just fine-tuned to the point that we can be very efficient and actually reliable to the level of almost like a research coordinator, is not just theory. Now, it can change lives because we can get patients enrolled in clinical trials and be activated in different places wherever the patient may be. I know it's like a long answer on that, but, you know, as we talk about responsible AI, that's important. And in terms of what keeps me up at night on this: data drift and biases, right? So, imaging protocols, all these things change, the lab switch between different vendors, or a patient has issues with new emerging data points. And health systems serve vastly different populations. So, if our models are trained in one context and deployed in another, then the output can be really inaccurate. So, the idea is to become a collaborative approach where we can use federated learning and patient-centricity so we can be much more efficient in developing those models that account for all the populations, and any retraining that is used based on data can be diverse enough that it represents all of us and we can be treated in a very good, appropriate way. So, if a clinician doesn't understand why a recommendation is made, as you probably know, you probably don't trust it, and we shouldn't expect them to. So, I think this is the next wave of the future. We need to make sure that we account for all those things. Dr. Paul Hanona: Absolutely. And even the part about the clinical trials, I want to dive a little bit more into in a few questions. I just kind of wanted to make a quick comment. Like you said, some of the prevalent things that I see are the ambient scribes. It seems like that's really taken off in the last year, and it seems like it's improving at a pretty dramatic speed as well. I wonder how quickly that'll get adopted by the majority of physicians or practitioners in general throughout the country. And you also mentioned things with AI tools regarding helping regulators move things quicker, even the radiation oncologist, helping them in their workflow with contouring and what else they might have to do. And again, the clinical trials thing will be quite interesting to get into. The first question I had subsequent to that is just more so when you have large datasets. And this pertains to two things: the paper that you published recently regarding different ways to use AI in the space of oncology referred to drug development, the way that we look at how we design drugs, specifically anticancer drugs, is pretty cumbersome. The steps that you have to take to design something, to make sure that one chemical will fit into the right chemical or the structure of the molecule, that takes a lot of time to tinker with. What are your thoughts on AI tools to help accelerate drug development? Dr. Arturo Loaiza-Bonilla: Yes, that's the Holy Grail and something that I feel we should dedicate as much time and effort as possible because it relies on multimodality. It cannot be solved by just looking at patient histories. It cannot be solved by just looking at the tissue alone. It's combining all these different datasets and being able to understand the microenvironment, the patient condition and prior treatments, and how dynamic changes that we do through interventions and also exposome – the things that happen outside of the patient's own control – can be leveraged to determine like what's the best next step in terms of drugs. So, the ones that we heard the news the most is, for example, the Nobel Prize-winning [for Chemistry awarded to Demis Hassabis and John Jumper for] AlphaFold, an AI system that predicts protein structures right? So, we solved this very interesting concept of protein folding where, in the past, it would take the history of the known universe, basically – what's called the Levinthal's paradox – to be able to just predict on amino acid structure alone or the sequence alone, the way that three-dimensionally the proteins will fold. So, with that problem being solved and the Nobel Prize being won, the next step is, “Okay, now we know how this protein is there and just by sequence, how can we really understand any new drug that can be used as a candidate and leverage all the data that has been done for many years of testing against a specific protein or a specific gene or knockouts and what not?” So, this is the future of oncology and where we're probably seeing a lot of investments on that. The key challenge here is mostly working on the side of not just looking at pathology, but leveraging this digital pathology with whole slide imaging and identifying the microenvironment of that specific tissue. There's a number of efforts currently being done. One isn't just H&E, like hematoxylin and eosin, slides alone, but with whole imaging, now we can use expression profiles, spatial transcriptomics, and gene whole exome sequencing in the same space and use this transformer technology in a multimodality approach that we know already the slide or the pathology, but can we use that to understand, like, if I knock out this gene, how is the microenvironment going to change to see if an immunotherapy may work better, right? If we can make a microenvironment more reactive towards a cytotoxic T cell profile, for example. So, that is the way where we're really seeing the field moving forward, using multimodality for drug discovery. So, the FDA now seems to be very eager to support those initiatives, so that's of course welcome. And now the key thing is the investment to do this in a meaningful way so we can see those candidates that we're seeing from different companies now being leveraged for rare disease, for things that are going to be almost impossible to collect enough data, and make it efficient by using these algorithms that sometimes, just with multiple masking – basically, what they do is they mask all the features and force the algorithm to find solutions based on the specific inputs or prompts we're doing. So, I'm very excited about that, and I think we're going to be seeing that in the future. Dr. Paul Hanona: So, essentially, in a nutshell, we're saying we have the cancer, which is maybe a dandelion in a field of grass, and we want to see the grass that's surrounding the dandelion, which is the pathology slides. The problem is, to the human eye, it's almost impossible to look at every single piece of grass that's surrounding the dandelion. And so, with tools like AI, we can greatly accelerate our study of the microenvironment or the grass that's surrounding the dandelion and better tailor therapy, come up with therapy. Otherwise, like you said, to truly generate a drug, this would take years and years. We just don't have the throughput to get to answers like that unless we have something like AI to help us. Dr. Arturo Loaiza-Bonilla: Correct. Dr. Paul Hanona: And then, clinical trials. Now, this is an interesting conversation because if you ever look up our national guidelines as oncologists, there's always a mention of, if treatment fails, consider clinical trials. Or in the really aggressive cancers, sometimes you might just start out with clinical trials. You don't even give the standard first-line therapy because of how ineffective it is. There are a few issues with clinical trials that people might not be aware of, but the fact that the majority of patients who should be on clinical trials are never given the chance to be on clinical trials, whether that's because of proximity, right, they might live somewhere that's far from the institution, or for whatever reason, they don't qualify for the clinical trial, they don't meet the strict inclusion criteria.  But a reason you mentioned early on is that it's simply impossible for someone to be aware of every single clinical trial that's out there. And then even if you are aware of those clinical trials, to actually find the sites and put in the time could take hours. And so, how is AI going to revolutionize that? Because in my mind, it's not that we're inventing a new tool. Clinical trials have always been available. We just can't access them. So, if we have a tool that helps with access, wouldn't that be huge? Dr. Arturo Loaiza-Bonilla: Correct. And that has been one of my passions. And for those who know me and follow me and we've spoke about it in different settings, that's something that I think we can solve. This other paradox, which is the clinical trial enrollment paradox, right? We have tens of thousands of clinical trials available with millions of patients eager to learn about trials, but we don't enroll enough and many trials close to accrual because of lack of enrollment. It is completely paradoxical and it's because of that misalignment because patients don't know where to go for trials and sites don't know what patients they can help because they haven't reached their doors yet. So, the solution has to be patient-centric, right? We have to put the patient at the center of the equation. And that was precisely what we had been discussing during the ASCO meeting. There was an ASCO Education Session where we talked about digital prescreening hubs, where we, in a patient-centric manner, the same way we look for Uber, Instacart, any solution that you may think of that you want something that can be leveraged in real time, we can use these real-world data streams from the patient directly, from hospitals, from pathology labs, from genomics companies, to continuously screen patients who can match to the inclusion/exclusion criteria of unique trials. So, when the patient walks into the clinic, the system already knows if there's a trial and alerts the site proactively. The patient can actually also do decentralization. So, there's a number of decentralized clinical trial solutions that are using what I call the “click and mortar” approach, which is basically the patient is checking digitally and then goes to the site to activate. We can also have the click and mortar in the bidirectional way where the patient is engaged in person and then you give the solution like the ones that are being offered on things that we're doing at Massive Bio and beyond, which is having the patient to access all that information and then they make decisions and enroll when the time is right.  As I mentioned earlier, there is this concept drift where clinical trials open and close, the patient line of therapy changes, new approvals come in and out, and sites may not be available at a given time but may be later. So, having that real-time alerts using tools that are able already to extract data from summarization that we already have in different settings and doing this natural language ingestion, we can not only solve this issue with manual chart review, which is extremely cumbersome and takes forever and takes to a lot of one-time assessments with very high screen failures, to a real-time dynamic approach where the patient, as they get closer to that eligibility criteria, they get engaged. And those tools can be built to activate trials, audit trials, and make them better and accessible to patients. And something that we know is, for example, 91%-plus of Americans live close to either a pharmacy or an imaging center. So, imagine that we can potentially activate certain of those trials in those locations. So, there's a number of pharmacies, special pharmacies, Walgreens, and sometimes CVS trying to do some of those efforts. So, I think the sky's the limit in terms of us working together. And we've been talking with corporate groups, they're all interested in those efforts as well, to getting patients digitally enabled and then activate the same way we activate the NCTN network of the corporate groups, that are almost just-in-time. You can activate a trial the patient is eligible for and we get all these breakthroughs from the NIH and NCI, just activate it in my site within a week or so, as long as we have the understanding of the protocol. So, using clinical trial matching in a digitally enabled way and then activate in that same fashion, but not only for NCTN studies, but all the studies that we have available will be the key of the future through those prescreening hubs. So, I think now we're at this very important time where collaboration is the important part and having this silo-breaking approach with interoperability where we can leverage data from any data source and from any electronic medical records and whatnot is going to be essential for us to move forward because now we have the tools to do so with our phones, with our interests, and with the multiple clinical trials that are coming into the pipelines. Dr. Paul Hanona: I just want to point out that the way you described the process involves several variables that practitioners often don't think about. We don't realize the 15 steps that are happening in the background. But just as a clarifier, how much time is it taking now to get one patient enrolled on a clinical trial? Is it on the order of maybe 5 to 10 hours for one patient by the time the manual chart review happens, by the time the matching happens, the calls go out, the sign-up, all this? And how much time do you think a tool that could match those trials quicker and get you enrolled quicker could save? Would it be maybe an hour instead of 15 hours? What's your thought process on that? Dr. Arturo Loaiza-Bonilla: Yeah, exactly. So one is the matching, the other one is the enrollment, which, as you mentioned, is very important. So, it can take, from, as you said, probably between 4 days to sometimes 30 days. Sometimes that's how long it takes for all the things to be parsed out in terms of logistics and things that could be done now agentically. So, we can use agents to solve those different steps that may take multiple individuals. We can just do it as a supply chain approach where all those different steps can be done by a single agent in a simultaneous fashion and then we can get things much faster. With an AI-based solution using these frontier models and multi-agentic AI – and we presented some of this data in ASCO as well – you can do 5,000 patients in an hour, right? So, just enrolling is going to be between an hour and maximum enrollment, it could be 7 days for those 5,000 patients if it was done at scale in a multi-level approach where we have all the trials available. Dr. Paul Hanona: No, definitely a very exciting aspect of our future as oncologists. It's one thing to have really neat, novel mechanisms of treatment, but what good is it if we can't actually get it to people who need it? I'm very much looking for the future of that.  One of the last questions I want to ask you is another prevalent way that people use AI is just simply looking up questions, right? So, traditionally, the workflow for oncologists is maybe going on national guidelines and looking up the stage of the cancer and seeing what treatments are available and then referencing the papers and looking at who was included, who wasn't included, the side effects to be aware of, and sort of coming up with a decision as to how to treat a cancer patient. But now, just in the last few years, we've had several tools become available that make getting questions easier, make getting answers easier, whether that's something like OpenAI's tools or Perplexity or Doximity or OpenEvidence or even ASCO has a Guidelines Assistant as well that is drawing from their own guidelines as to how to treat different cancers. Do you see these replacing traditional sources? Do you see them saving us a lot more time so that we can be more productive in clinic? What do you think is the role that they're going to play with patient care? Dr. Arturo Loaiza-Bonilla: Such a relevant question, particularly at this time, because these AI-enabled query tools, they're coming left and right and becoming increasingly common in our daily workflows and things that we're doing. So, traditionally, when we go and we look for national guidelines, we try to understand the context ourselves and then we make treatment decisions accordingly. But that is a lot of a process that now AI is helping us to solve. So, at face value, it seems like an efficiency win, but in many cases, I personally evaluate platforms as the chief of hem/onc at St. Luke's and also having led the digital engagement things through Massive Bio and trying to put things together, I can tell you this: not all tools are created equal. In cancer care, each data point can mean the difference between cure and progression, so we cannot really take a lot of shortcuts in this case or have unverified output. So, the tools are helpful, but it has to be grounded in truth, in trusted data sources, and they need to be continuously updated with, like, ASCO and NCCN and others. So, the reason why the ASCO Guidelines Assistant, for instance, works is because it builds on all these recommendations, is assessed by end users like ourselves. So, that kind of verification is critical, right? We're entering a phase where even the source material may be AI-generated. So, the role of human expert validation is really actually more important, not less important. You know, generalist LLMs, even when fine-tuned, they may not be enough. You can pull a few API calls from PubMed, etc., but what we need now is specialized, context-aware, agentic tools that can interpret multimodal and real-time clinical inputs. So, something that we are continuing to check on and very relevant to have entities and bodies like ASCO looking into this so they can help us to be really efficient and really help our patients. Dr. Paul Hanona: Dr. Bonilla, what do you want to leave the listener with in terms of the future direction of AI, things that we should be cautious about, and things that we should be optimistic about? Dr. Arturo Loaiza-Bonilla: Looking 5 years ahead, I think there's enormous promise. As you know, I'm an AI enthusiast, but always, there's a few priorities that I think – 3 of them, I think – we need to tackle head-on. First is algorithmic equity. So, most AI tools today are trained on data from academic medical centers but not necessarily from community practices or underrepresented populations, particularly when you're looking at radiology, pathology, and what not. So, those blind spots, they need to be filled, and we can eliminate a lot of disparities in cancer care. So, those frameworks to incentivize while keeping the data sharing using federated models and things that we can optimize is key. The second one is the governance on the lifecycle. So, you know, AI is not really static. So, unlike a drug that is approved and it just, you know, works always, AI changes. So, we need to make sure that we have tools that are able to retrain and recall when things degrade or models drift. So, we need to use up-to-date AI for clinical practice, so we are going to be in constant revalidation and make it really easy to do. And lastly, the human-AI interface. You know, clinicians don't need more noise or we don't need more black boxes. We need decision support that is clear, that we can interpret, and that is actionable. “Why are you using this? Why did we choose this drug? Why this dose? Why now?” So, all these things are going to help us and that allows us to trace evidence with a single click. So, I always call it back to the Moravec's paradox where we say, you know, evolution gave us so much energy to discern in the sensory-neural and dexterity. That's what we're going to be taking care of patients. We can use AI to really be a force to help us to be better clinicians and not to really replace us. So, if we get this right and we decide for transparency with trust, inclusion, etc., it will never replace any of our work, which is so important, as much as we want, we can actually take care of patients and be personalized, timely, and equitable. So, all those things are what get me excited every single day about these conversations on AI. Dr. Paul Hanona: All great thoughts, Dr. Bonilla. I'm very excited to see how this field evolves. I'm excited to see how oncologists really come to this field. I think with technology, there's always a bit of a lag in adopting it, but I think if we jump on board and grow with it, we can do amazing things for the field of oncology in general. Thank you for the advancements that you've made in your own career in the field of AI and oncology and just ultimately with the hopeful outcomes of improving patient care, especially cancer patients. Dr. Arturo Loaiza-Bonilla: Thank you so much, Dr. Hanona. Dr. Paul Hanona: Thanks to our listeners for your time today. If you value the insights that you hear on ASCO Daily News Podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. More on today's speakers:    Dr. Arturo Loaiza-Bonilla @DrBonillaOnc Dr. Paul Hanona @DoctorDiscover on YouTube Follow ASCO on social media:      @ASCO on Twitter      ASCO on Facebook      ASCO on LinkedIn    ASCO on BlueSky Disclosures: Paul Hanona: No relationships to disclose. Dr. Arturo-Loaiza-Bonilla: Leadership: Massive Bio Stock & Other Ownership Interests: Massive Bio Consulting or Advisory Role: Massive Bio, Bayer, PSI, BrightInsight, CardinalHealth, Pfizer, AstraZeneca, Medscape Speakers' Bureau: Guardant Health, Ipsen, AstraZeneca/Daiichi Sankyo, Natera

In this episode, I go over 8 lessons to maximize your first 90 days in Life Sciences. These include understanding the impact of their roles, adopting a professional mindset, passing the first 90-day test, avoiding the 'silent trap,' finding mentors, valuing feedback, mastering systems, and taking responsibility for their careers. Subhi emphasizes that these lessons can significantly accelerate growth and career advancement for newcomers to the industry.Link to course: subhisaadeh.gumroad.com/l/6figurebiomedical00:00 Introduction: Starting Your Career Journey00:54 Lesson 1: Your Role Can Have a Big Impact02:55 Lesson 2: Adopting a Professional Mindset04:06 Lesson 3: The First 90 Days Are Crucial05:09 Lesson 4: Avoiding the Silent Trap06:35 Lesson 5: Finding the Right Mentors07:14 Lesson 6: Embrace Feedback as Fuel07:51 Lesson 7: Mastering the Systems08:47 Lesson 8: Taking Responsibility for Your Career09:19 Conclusion and Additional ResourcesSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode of Medsider Radio, we had a fascinating chat with Mary Lou Jepsen, founder and Chairman of Openwater, a medtech company developing breakthrough diagnostic and therapeutic wearables for cancer, stroke, mental illness, and beyond. Openwater is rethinking how medical devices are built — not as single-purpose machines, but as flexible platforms that function more like smartphones. A physicist and prolific inventor, Mary Lou holds nearly 300 patents and has launched over 50 products across VR, AR, holography, and consumer electronics. Previously, she led engineering at Intel, Facebook, and Google, taught at MIT, and now serves on the boards of Lear Corporation and Luminar Technologies. She has been named to Time magazine's list of the 100 most influential people. In this interview, Mary Lou explains why the traditional “one disease, one device” model falls short, and how her team is applying consumer electronics and open-source principles to develop scalable, software-driven tools. Backed by renowned investors including Khosla Ventures, Vitalik Buterin, and Esther Dyson, Openwater is aiming to make advanced care more accessible worldwide.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Mary Lou Jepsen.

In this episode, Duane Mancini welcomes Bob Roda, President and CEO of HemoSonics, to discuss the essential components of building a successful and purpose-driven career in the medical device industry. The conversation explores Bob's formative experiences at Johnson & Johnson and Becton Dickson, the critical need for purpose as a guiding principle, and the continuous process of learning and absorbing information. They delve into practical strategies for building brand equity, the intricacies of the selling process, and the thinking behind acquisition strategy and innovation, including his commercial due diligence on CareFusion. The episode also introduces the value of context and being humbled, highlighting how vulnerability creates connection and why adapting your communication style like a "chameleon" is crucial for impactful leadership.Bob Roda LinkedInHemoSonics WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedIn

As global clinical trials become more competitive and data-driven, Latin America is stepping up with a new global standard in clinical trial quality. In this episode, Etienne Nichols speaks with Julio Martinez-Clark, CEO of BioAccess and a key advocate for clinical site certification in Latin America. They discuss the launch of the GCSA certification and IAOCR accreditation now available in the Americas, exploring how these standards improve site credibility, de-risk clinical trials, and offer faster pathways for medtech market access. From regulatory advantages to site selection strategies, this episode is essential listening for sponsors, CROs, and MedTech leaders navigating global trials.Key Timestamps00:02 – Introduction to Julio Martinez-Clark and episode overview02:10 – What is GCSA and IAOCR certification?06:00 – Why certification is emerging now: volume, complexity, and patient safety09:42 – Certification structure: site vs. individual requirements13:45 – The Colombian model: First mover in Latin America17:55 – Global harmonization vs. local certification pitfalls21:30 – Measuring ROI of certified vs. non-certified sites26:15 – Future of global site certification and Latin America's role30:00 – Regional differences: speed vs. patient pool in trial site selection36:15 – Final thoughts on FDA trends and LATAM's emerging positionQuotes“It's appalling that in an industry that deals with lives, there was no global standard to certify site or individual competency—until now.”– Julio Martinez-ClarkWhy it matters: This underscores the critical gap in clinical research infrastructure and the urgent need for standards like GCSA.“You can't measure quality without a shared framework. Certification levels the playing field globally.”– Julio Martinez-ClarkWhy it matters: This highlights how global certification allows consistent benchmarking across clinical sites, benefitting sponsors and patients alike.Key TakeawaysGCSA Certification Elevates Site Credibility: Clinical sites with GCSA certification are fast-tracked for sponsor consideration, leading to better trial access and more robust patient recruitment.IAOCR Accreditation Validates Individual Competency: For investigators, coordinators, and site managers, individual accreditation under the UNESCO-backed IAOCR framework offers a portable, verifiable skillset.Latin America Offers Dual Advantages: With rapid recruitment and cost-effective data generation, LATAM is uniquely positioned to lead in globally certified trials—especially Colombia, which already mandates certification.Global Harmonization is Critical: Fragmented local certifications can deter sponsors. A unified global framework like GCSA simplifies compliance, increases efficiency, and builds trust.The FDA Bottleneck May Shift Market Entry: With regulatory delays in the U.S., more medtech firms may turn to Latin America for first-in-human trials and initial commercialization.ReferencesJulio Martinez-Clark on LinkedInBioaccess LATAMIAOCR – International Accreditation Organization for Clinical ResearchEtienne Nichols on LinkedInMedTech 101: What

Send us a textWhen people talk about clinical trials, they usually think of drugs, but what about the tools that deliver, diagnose, and detect? Medical device Innovation often flies under the radar despite being essential to modern care. In this episode of the HealthBiz Podcast, Jason Monteleone, CEO of Avania, discusses how his firm helps medtech, diagnostics, and digital health companies navigate clinical trials and regulatory hurdles.

In this episode of Medsider Radio, we sat down with Anthony Fernando, President and CEO of Asensus Surgical.Asensus is expanding the role of robotics in the OR with its performance-guided surgery platform — a digital-first, AI-enabled system designed to enhance precision and real-time decision-making. A mechanical engineer by training, Anthony has more than two decades of experience spanning medtech, robotics, and global operations. He joined Asensus in 2015 and previously served as Chief Operating Officer and Chief Technology Officer. Earlier in his career, Anthony held leadership roles at Stryker, Becton Dickinson, PerkinElmer, and Varian, where he focused on advancing automation and medical device innovation across international markets.In this interview, Anthony shares how the Durham, NC–based Asensus navigated uncharted regulatory territory for a first-of-its-kind technology and proactively made the case for acquisition — well before KARL STORZ came to the table.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Anthony Fernando.

In this episode, Duane Mancini welcomes Brian Morley, CMO of Native Orthopaedics, and returning guest Tino Chow, CEO and Founder at Giant Shoulders, to discuss the critical aspects of building and growing a medtech brand. The conversation explores Brian's journey into Native Orthopaedics, the importance of a clear, operationalized vision for startups, and how to effectively balance creative ideation with execution. They delve into practical strategies for achieving brand alignment, identifying when a rebrand is necessary, and leveraging the digital age for reach. The episode also introduces the valuable concept of visionary and integrator roles, highlighting how a strong brand can serve as an integrator to connect a company's vision with its team and partners.Brian Morley LinkedInNative Orthopaedics WebsiteTino Chow LinkedInGiant Shoulders WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedIn

MedTech graveyards are full of clever devices that never made it past the demo. Dr. Tori O'Daniel (OB/GYN, Medical Director, Oklahoma City) walks us through the five adoption pillars that separate shelf-ware from standard-of-care.In This Episode• The “ease-of-use” litmus test every new device must pass• Why education is a FOREVER activity, not a launch event• How to spot (and empower) your Champion-for-Change• Talking cost: shifting the conversation from unit price to total value• Template-driven VAC submissions that save months of back-and-forth

As drug abuse rises globally, organizations and governments are turning to preventive solutions. With over 450 active accounts across 24 countries, Intelligent Bio Solutions (Nasdaq: INBS) is making a significant impact through its Intelligent Fingerprinting Drug Screening System.In this interview, Doug Heath, VP of Global Sales, and Anna Turkington, VP of Marketing, discuss how the company is advancing portable, rapid, and pain-free drug testing using its fingerprint-based screening technology.They also share insights into Intelligent Bio Solutions' business model, growth outlook, market opportunity, and global expansion strategy.Find out more: https://ibs.inc/Watch the full YouTube interview here: https://youtu.be/qHeVoWcBU_U And follow us to stay updated: https://www.youtube.com/@GlobalOneMedia?sub_confirmation=1