Podcasts about Medtech

Clinicians saying they love your product doesn't mean hospitals will adopt it — and that gap is where clinician-led MedTech companies burn cash and lose momentum.In this episode, Hakeem is joined by Mark Tudor (20+ years in commercial leadership and advisory roles in medical devices) to break down why technically strong products stall after launch, how hospitals really decide what to buy, and how to build the commercial foundations that drive adoption, sales, and export readiness.Learn why commercial planning must run in parallel with product and regulatory workUnderstand what hospitals actually buy (risk management, simplicity, and economic clarity — not “better performance”)Get a practical lens for stakeholder mapping, validation beyond friendly opinions, and avoiding “inventor syndrome”Helping clinicians simplify their go-to-market strategy so they can stop guessing and turn their working prototypes into international MedTech businesses.Decision point scenario: You're advising a clinician founder with regulatory approval, two pilot sites, one keen-but-unproven distributor, limited runway, and 90 days before board pressure. You can only prioritise one focus — what do you choose and why? (Mark answers in the next episode.)If you tell me whether you want this episode to lean harder into adoption, hospital buying decisions, or export/distributor readiness, I'll pick the best 3 titles from above and tighten them even more.Message me via DM on LinkedinBook a 30 min discovery call for the Healthcare Export Accelerator ProgrammeThis podcast is for clinicians turning medical devices into real businesses, with practical insight on go to market strategy, exporting, and scaling in international MedTech.

What if the next medical breakthrough could be undone—not by biology—but by a hacker? In this episode of Med Tech Gurus, we sit down with Christian Espinosa, CEO and Founder of Blue Goat Cyber, a leading medical device cybersecurity consultancy helping innovators protect patients by securing the technology behind modern healthcare. With over 30 years of experience spanning the U.S. Air Force, Department of Defense, and MedTech industry, Christian brings a rare perspective on precision, resilience, and empathy in cybersecurity After a personal health scare revealed vulnerabilities in his own implanted device, Christian turned mission into movement—founding Blue Goat Cyber to transform cybersecurity from a regulatory afterthought into a strategic advantage Christian shares how patient safety—not data protection—must be the heart of every cybersecurity strategy, why "bolting on" security late in development can derail innovation, and how emotional intelligence drives his leadership in high-stakes medtech environments. Whether you're a startup founder, RA/QA leader, or healthcare executive, this episode delivers powerful lessons on building trust, protecting patients, and creating a culture where security saves lives.

If you only had 14 months of runway left, no international sales team, and one shot at entering a new export market… would you choose the one that looks impressive or the one that actually gives you the highest probability of revenue?Most MedTech founders believe they're making rational expansion decisions but under pressure, choices get driven by ego, investor optics, or the allure of a “big” market. With limited runway, one wrong move can quietly burn capital and delay global traction.In the previous episode, you built your export business plan. Today, we pressure-test it. We walk through the exact scenario I posed and reveal which market actually wins when you apply disciplined strategy instead of ambition.In this episode, you'll see exactly how to eliminate two markets and confidently choose the one most likely to generate traction within 12 months.By listening, you'll:See how to apply your export business plan to eliminate the wrong markets with confidenceLearn how to balance ambition with execution probability inside a 14-month runwayUse a 180-day reality filter to validate traction before committing capital and credibilityPress play now to learn how to choose the export market that compounds your growth not the one that drains your runway.Message me via DM on LinkedinBook a 30 min discovery call for the Healthcare Export Accelerator ProgrammeThis podcast is for clinicians turning medical devices into real businesses, with practical insight on go to market strategy, exporting, and scaling in international MedTech.

In this episode of Medsider Radio, we sat down with Rick Bente, co-founder and CEO of Indomo.Indomo's flagship device, ClearPen, is an investigational at-home corticosteroid injection designed to treat inflammatory acne.Rick has over 20 years of experience as an engineer and operator across medtech and pharma, with leadership roles at Medtronic, Insulet, and YourBio, focused on drug delivery and combination products. He is an inventor on more than 50 patents and has generated over $150 million in investments.In this conversation, Rick discusses how Indomo translated an in-office dermatology procedure into at-home care, why usability had to be engineered rather than trained, how the company decided when to exit stealth mode, and how proof-based milestones shaped its fundraising.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.And if you're ready to level up your medtech game, you should check out Medsider Courses — 8-week masterclasses covering topics like fundraising, M&A and exit planning, design and development, clinical and regulatory strategy, and commercialization.These courses, featuring hard-earned lessons from elite medtech CEOs, can be purchased individually or come free with our All-Access Pass.If you'd rather read than listen, here's a link to the full interview with Rick Bente.

Join us for a special 250th episode of The Project Medtech Podcast as host Duane Mancini and Director of Marketing and Engagement, Lindsey Dinneen, flip the script. Duane shares the journey from the podcast's inception during the height of COVID-19 to becoming a consulting, networking, and education resource for medtech startups. They delve into the core philosophy of creating value, the realities of team-building, and the exhilarating moments of client success. This episode is a candid reflection on the impact of the Project Medtech mission, the importance of a value-driven approach, and exciting future prospects. Lindsey Dinneen LinkedInDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law and JumpStart Inc.

This episode features Ivanny Franklin, Managing Partner at MedSight Capital, who brings a wealth of experience from her background in molecular biology and her decade-long tenure at NAMSA. The conversation centers on the shifting paradigms of medical device investment, specifically how the industry is moving away from service-based models toward a focus on clinical outcomes.Etienne and Ivanny explore the critical intersection of global regulatory bodies—such as the NMPA in China and the FDA in the US—and the necessity of a cohesive clinical evidence strategy. Ivanny emphasizes that for startups, understanding market-specific data requirements is not just a regulatory hurdle but a fundamental component of commercialization and investor conviction.The discussion also dives into the "patient empowerment" movement, fueled by the convergence of wearables, AI, and at-home monitoring. Ivanny shares her bullish outlook on technologies that give patients control over their data, while acknowledging the tension this creates for physicians and the ongoing need for rigorous regulatory oversight to ensure safety and effectiveness.Key Timestamps[03:15] Global Regulatory Strategy: Insights into the NMPA (formerly CFDA) and why China requires in-country clinical evidence.[07:42] Leveraging Data: How to run a single clinical trial to satisfy multiple global regulatory bodies.[10:18] The At-Home Monitoring Shift: The rise of wearables and OTC testing in the wake of COVID-19.[13:45] The "Data Gap": Addressing the friction between patient-gathered data and physician adoption.[18:22] Investment Non-Negotiables: Why revenue-generating companies and clear regulatory classifications are key for MedSight Capital.[23:10] Diligence and Deception: The importance of honesty regarding reimbursement codes and 510(k) vs. PMA paths.[27:45] SPV vs. Hedge Fund Models: A breakdown of how Special Purpose Vehicles allow family offices to be nimble in MedTech.Quotes"FDA and NMPA, for example, are quite strict in clinical evidence coming from in-country... as a startup, you really need to understand can we run a single trial with multiple global sites to achieve clearance cohesively." - Ivanny Franklin"I'm an advocate for [at-home monitoring]. I do think that's the future. However, there is concern around what types of information should patients be receiving and how are they going to act on that information?" - Ivanny FranklinTakeawaysRegulatory is the Roadmap: An investment is often "de-risked" based on the clarity of the regulatory path. If a founder cannot distinguish between a 510(k) and a PMA, it is a major red flag for investors.Harmonize Your Trials: To achieve "economies of scale" in clinical evidence, work with consultants to design trials that meet the stringent requirements of both the FDA and international bodies like the NMPA early on.

Dr. Amel Havkic, founder of EvoMed Consulting and a lung and critical care specialist, hospital clinical lead. Amel works at the intersection of bedside medicine and MedTech strategy, helping innovators build clinician-approved solutions that scale safely across real healthcare systems.In this episode, we unpack why “clinicians love it” is rarely enough to win adoption, and what hospital purchasing actually looks like when procurement, IT, finance, compliance and workflows all have a seat at the table. Amel breaks down why switching away from legacy tools is painful, how integrations can break care pathways, and why solutions that feel like a natural part of the hospital ecosystem win faster. He also shares a practical lens for building frictionless implementation by aligning with standards like HL7, FHIR and DICOM, while proving measurable value for patients and payers.We also go deep on decentralising healthcare. Amel explains how the Dutch model centralises high-end expertise while decentralising access through remote monitoring and home-based onboarding, and why this becomes a winning approach as staffing pressures rise. On AI, he makes the case for reframing it as augmented intelligence, not autonomy, and shows where decision support can raise the baseline of care by supporting clinicians in time-critical situations, as well as offloading admin burden that drains capacity.Finally, Amel shares the thinking behind the EMC StarMap framework, a navigation tool built from real-world patterns of what makes MedTech succeed or fail. His core message is simple: regulatory approval is a milestone, but clinical adoption is the real finish line.Timestamps[00:00:05] Clinician + Consultant Lens: Seeing Adoption and Safety Risks[00:01:22] Why “Physicians Love It” Does Not Mean Hospitals Will Buy[00:03:27] What Hospitals Consider Beyond Cost: Workflow, Integration and Training[00:05:09] Frictionless Implementation: Standards, EHR Fit and “Team Player” Products[00:06:24] Real Clinical Workflow: ICU Reality and Why UI Clicks Matter[00:07:31] Decentralising Care: Centralised Expertise With Home-Based Delivery[00:10:37] AI in Healthcare: Reframing as Augmented Intelligence[00:12:55] Staffing Shortages: Where AI Can Remove Waste and Scale Expertise[00:14:38] If You Could Change One Thing: Put the Patient Back at the Center[00:16:59] StarMap: Measuring What Drives Clinical AdoptionConnect with Rick - ⁠⁠⁠⁠https://www.linkedin.com/in/a-havkic/Learn more about Evomed Consulting - https://evomed-consulting.eu/Get in touch with Karandeep Badwal - ⁠⁠⁠⁠⁠https://www.linkedin.com/in/karandeepbadwal/ ⁠⁠⁠⁠⁠Follow Karandeep on YouTube - ⁠⁠⁠⁠⁠https://www.youtube.com/@KarandeepBadwal⁠⁠⁠⁠⁠Subscribe to the Podcast

Dr. Stuart Grant, founder of Archetype Medtech, shares his journey designing and delivering breakthrough orthopedic and surgical innovations across the UK, US, and China. Stuart recounts how an early internship led him into medtech, what kept him there, and how building the ASPAC Innovation Center in China helped accelerate a total knee instrument system that dramatically reduced time to market. He explains the leap from corporate leader to entrepreneur: planning for years, earning a PhD in Medtech Product Innovation, and building a consultancy that helps startups and scale-ups turn early clinical unmet needs into market-ready, regulator-approved devices through a network of experts and an “expertise for equity” model.    Guest links: https://archetype-medtech.com/  Charity supported: Sleep in Heavenly Peace Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com.  PRODUCTION CREDITS Host & Editor: Lindsey Dinneen Producer: Velentium Medical   EPISODE TRANSCRIPT Episode 074 - Stuart Grant [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of the Leading Difference podcast. I'm your host Lindsey, and today I'm delighted to welcome Dr. Stuart Grant. Dr. Grant is a chartered engineer and the founder of Archetype Medtech, a consultancy and innovation studio helping medical device startups and scale ups transform early clinical, unmet needs into market ready products. With nearly 25 years of experience, Stuart has led global teams across the UK, US, China, and emerging markets delivering breakthrough innovations in hip, knee, shoulder, and trauma surgery. A highlight of his career was establishing the ASPAC Innovation Center in China, where he built R&D capability from the ground up and launched a pioneering total knee instrument system that dramatically reduced time to market. Passionate about advancing medical technology and mentoring future engineers, he bridges creativity, engineering, and regulation to accelerate safer, smarter medtech innovation worldwide. All right. Welcome to the show. It's so great to have you here today. Thanks for joining me. [00:01:57] Stuart Grant: It's lovely to be here, Lindsey. [00:01:58] Lindsey Dinneen: Yeah. Excellent. Well, I was wondering if you could start by sharing a little bit about yourself, your background, and what led you to medtech. [00:02:08] Stuart Grant: Yeah. So, I was actually, I'm obviously, as you can tell from my accent, I'm British, but I was born in Germany because my, my dad was in the military in the 1970s when I was born. So I was born actually in Berlin, which is quite interesting to be a place to be, grew up in. So I traveled around a lot here in the UK, in Germany with my dad getting posted everywhere. My mom's a nurse. So I was in medtech, not really knowing I was in medtech as a kid, but I, my family was, so yeah. And then obviously went to school, all the places I was at university. I went to university to do product design, and my goal was to be a product designer, a cool product designer, designing fancy products like Johnny Ive. And when I was looking for a job as a co-op, or an intern as you call them in the US, I was just really unsuccessful finding a job. I was doing a lot of interviews, getting turned down, sending my CV out a lot, and j happened just to advertise on the Board of University, and it said Johnson Orthopedics and no one really knew what that was in. And none of my fellow students at applied because they thought it would be designing baby bottles for putting talcum powder in and shampoo in and stuff like that. So they're like, "I'm not doing that job." So I desperately applied for it and luckily found out about all this medtech, and I've been here doing medtech for 25 years. So they gave me a job. I had to work hard to keep the job and get reemployed over and over again. But yeah, joining originally Johnson Orthopedics a long time ago is how I found out about medtech. I never knew when I was 18 that really it was a thing that existed. [00:03:47] Lindsey Dinneen: Yeah. So, okay. So you thought product design, and then when you got into medtech, what were some of the things that attracted you and that actually compelled you to stay and make a career out of it? [00:04:00] Stuart Grant: Ha. So I was a young guy with the student debts. What compelled me, I was getting paid to stay, but not to be too flippant about it, but, you know, when I was doing this engineering and design work in my early days in the CAD system, it was just so interesting. I was designing these products that were going into people or the instrumentation to make help the surgeon and going to these ORs and watching the surgeon do their job and trying to figure out how how I can make it better from their input was really interesting. I could apply it straight away, basically. In the early two thousands, there wasn't all these regulations and standards that slowed you down. So you could go and design an instrument, get it machined in the machine shop, get it clean, take it to the surgeon, he can use it, you know, probably be frowned upon 25 years later. But that's what we used to do and really adapt. And probably more interesting than going into product design and fast moving consumer goods where you're designing a, a kettle or a toaster or something, a plastic casing. It was actually much more interesting to do that. And I stayed because I spent four years here in Leeds, in the UK, was getting a bit bored and wanted to find something else to do, and then an opportunity came up in the US. So I moved over to Warsaw, Indiana, the orthopedics capital of the world, as you might know it. Worked there for, stayed there for seven years. Really enjoyed it.. People sort of bemoan Warsaw for being in the sticks in just a bunch of cornfields around it. But I enjoyed it. It's got, we had a good bunch of young friends there. I was in late twenties, early thirties at the time. There was Noah and Spikes. You'd go for a drink and some nice food. It was all right. I enjoyed my time and after that I was, after seven years, I was like, "Okay, what do I do next?" And I was looking around for jobs in medtech. Then another opportunity came up in and we were looking for people to go over and help set it up, train the staff on what MedTech product development was. And so I jumped to the chance and spent five years living in China, in Shanghai. After five years is your limit, so I had to come home. I couldn't stay. I wanted to stay, but they wouldn't allow me to. So, so I came back to the UK. And then started MDR for five years as leading the Joints MDR program, which was lots of fun, as you could probably tell, wasn't really R&D, was a lot of leadership and project management and dealing with a lot of people and a lot of problems on a day-to-day basis. And so, yeah, after that I I left J&J about three years ago and started my own product development agency. And we can talk about a little bit about that later. So that's where I am and where I got to. [00:06:50] Lindsey Dinneen: Excellent. Yeah, I definitely wanna talk about that as well. But going back a little bit-- and perhaps this is actually something that's occurred since you started your own company as well-- but are there any moments that really stand out to you along your journey of affirming that, "Hey, yeah, I actually am in the right place, in the right industry?" [00:07:12] Stuart Grant: That's a really hard one is sort of the, is the grass always greener somewhere else, type of question. Right? I guess compare, you shouldn't compare, but comparing to my friends at my university, my product design and what they've done and what I've done they've moved into the car industry a lot. Went to the car development and car industries always had its ups and downs and its problems. And you know, they've had some really cracking jobs working for McLaren and Ferrari and you know, but I think just the interesting things that medtech do that nobody really knows about is really what keeps me moving along and having conversations with people when they, you tell them like, "I used to design hips and knees and shoulders and things like that," and they're like, "Oh, my mother's got a hip and knee" and blah, blah, and you really talk about it. Actually, my mother does have a hip now and she's going in a couple months time to get the other hip done. I do know what brand she's got, so. [00:08:10] Lindsey Dinneen: See, that's really cool. Yeah. Okay. So, so, on your LinkedIn I noticed that you describe yourself as a fixer, a challenger, and a change maker, which I love. But I'd love to hear from you exactly what you mean by all those things as you have developed in your career, and now as you're doing, of course, your own consulting. [00:08:34] Stuart Grant: Yeah, so in Johnson and my colleagues are probably, I agree with this, I had a bit of a reputation of getting the more difficult projects. The, that's probably why I got MDR in the end 'cause I would always get the projects that had problems and I enjoyed that. I liked digging deep and solving the problem and wrangling everyone together and pushing everybody along to help. And that was actually one of the reasons why I moved to the US 'cause the original project I moved to was the project leader left and it was in a bit of a shambles. So I went over to sort of, sort of try and get it together and just ended up staying and working on multiple projects. So I like that. Really challenging, not just the engineering side. The engineering side is obviously really interesting, but the challenging project management and people management and process management in a big corporation, all of those things, people, product, process, all come together just to cause a big headache sometimes, you know, herding cats as say and going, trying to solve those problems as an engineer, always trying to solve these problems, right? So it's you're always trying to figure out how you can move forward. [00:09:52] Lindsey Dinneen: Yeah. Yeah, absolutely. So, okay, so that kind of brings us to the company. So what was it like going from employee to entrepreneur? Were you, did you feel ready and prepared for that leap? Or what has that transition and pathway been for you? [00:10:10] Stuart Grant: So I've, I was a long-term planner. I was planning for this for five years whilst I was working for Johnson. So I went and got, when I came back to the UK I started my PhD and I knew getting a PhD was a real way of building credibility immediately, right? Before you step in a room and have a conversation with you, if you've got a PhD in the subject you're about to talk about, people pay attention, hopefully. Right? So I did my, so I did my PhD in Medtech Product Innovation, what the process is. So I spent seven years part-time working for Johnson, getting my PhD, knowing that eventually in my mid forties, there'll be an inflection point, which usually isn't people in big corporations, right, that either stay to the end for until you're six, mid sixties. If you hit 50, usually stay for the next decade, right? Or you leave and do something else. And I was like, "Okay, 45, I'm gonna pull the bandaid, go in, get my PhD, set up my own company plan, get the plan to do it, get the savings," and so I was working on MDR and a new MDR was coming to an end, and then they'd have to find me a new project, which probably didn't exist. So I also knew that J&J would be like, "Ah, Stuart, you've been here for 23 years. There's not really anything of your level here." I'd be like, "Great, let's go." So this was all a, you always it's a big step, right? I have a family. I can't just sort of walk in, not come in the office anymore. So it was a big plan that my wife and I had for quite a number of years to execute. So it's still a struggle. I've been doing it for three years. It's still hard work, still building the company, finding clients, understanding what their pain points are and improving your picture and all those other things, still is still a challenge, but it's a new challenge. [00:12:06] Lindsey Dinneen: Yeah. [00:12:07] Stuart Grant: And as I say, as I said, when people worry about the risk, it's like I can easily just go and get a corporate job again as a move back and have all this new relevant experience. So it's a risk, but you have to balance that by the benefits. [00:12:21] Lindsey Dinneen: Yeah, calculated risk that you've planned for, so good for you. So, okay, so tell us a little bit about your company now and who you help and kind of where in the development or even ideation process that you can come in and really make a difference. [00:12:40] Stuart Grant: So, yeah, so Archetype MedTech is a product development, product innovation agency. And what we do, we usually work with startups or scale ups. Startup side, they'll have a proof of concept. They've already defined the unmet clinical need. They've sort of wrangled the technology and validated the actual technology does what it they're trying to make it do, but they just dunno how to make this a medical device product, right? They've they've got the technology, but they dunno how the product make a product that's sellable is releasable and it gets approved by FDA or here in the, i'll say here in the EU, I know I said in the UK, but MDR and I help them work out that product innovation strategy. So take them all through either they need to do the frontend innovation and understand their needs and the insights and the business case, and then the engineering requirements and specifications. The design and engineering part I help them with, and this is not just me. I have a network of experts, a sort of consortium of experts that come together and bring all these different specialties and then we help them with the testing, what testing they need to do, their risk management, usability, all that fun stuff. And then contact and help them work with the manufacturers. So contract manufacturers, then their regulatory approval. So really what we try to do is, 'cause we're bringing all this expertise as a group of people together, the entrepreneur, usually a salesman or surgeon at this point, who may be a university spin out, can spend a lot of time and money trying to find these experts, trying to find these resources, trying to understand the product development, the MedTech product development process, which is all written down in various books, but when you get down to the details, it gets really complicated. So what we do is help them go through that as fast and as efficiently as a possible, so they're not wasting capital fishing around for those experts. We already have that network of experts that we can bring in and take them through the process as quickly as possible. So that's what Archetype Medtech do for our clients. And has been successful. We have quite a number of clients, mostly in orthopedics and surgical 'cause that's my specialty in medtech. And what we also do, we just don't want to be a management consultancy firm. Well, we do if it's right, we share what we call expertise for equity. So we'll take some equity from the company, but we'll cut our day rates or maybe do it for free, do and help them go through the process as quickly as possible. That means we've got skin in the game, right? We're not just taking their money and going, "Great. This is great. Good luck on the commercialization. Not our problem." [00:15:29] Lindsey Dinneen: Right. [00:15:30] Stuart Grant: It is our problem. 'cause we want a return on our risk and our investment as well. So, yeah, that's what we try to do. And along with that we do a load of pro bono work with surgeons in the NHS who have had ideas. We help them just get their idea a bit further along so they can start looking for funding and investment, and I can share that with you later 'cause it's a really important program that the NHS run it. If there's any mentors out there that want to get involved I can point them in the right direction. [00:16:00] Lindsey Dinneen: Actually that's fantastic and I would love to hear a little bit more about the organization and yeah, how people can get involved and help and what do they all do. [00:16:10] Stuart Grant: Yeah. So the NHS have set up this called NHS Clinical Entrepreneurs Program. This is not my company. This is a completely separate organization. And what it is, clinicians, anybody who works in the NHS-- you know NHS is a 1.6 million people who are employed in the NHS. It's a massive company organization. They come up with clinical needs 'cause they're in the problem and they start working out how they solve it, even through medical device or health tech or an app or anything, right? And they can go into this, it is basically the equivalent of an accelerator program over about nine months. And we have mentors like myself who work with those clinicians to help them develop their idea. So I've got a couple of clinicians that I work with. One is developing a neurosurgical device for helping him cut out tumors in the brain. At the moment, they use two tools. They use a scalpel and a cordy, a bipolar cordy, and they're very basic tools. And what he has to do, he's under a microscope, and he has to swap these one by one, does this scalpel to cut the vascularization of the tumor. Then he has to seal it. And he has to pass the nurse has to pass in these tools and he can't see a, see the nurse passing him. So he is like, "Can I develop a tool that's in one a scalpel and a bipolar" so he doesn't have to keep changing the tool in his hand? And you can know by the cognitive load and changing that tool in the field that these surgeries take eight to 12 hours to cut out a tumor from the brain. So he's saying every, he swaps his tool about 200 times and it takes three seconds. So you can start doing the maths. [00:17:59] Lindsey Dinneen: Yeah. [00:18:01] Stuart Grant: Yeah. And then the other, so the other is a doctor, actually, the doc is a neonatal doctor and he's trying to develop a langoscope for neonatal babies. The langoscopes at the moment haven't really improved in the last 60 years. The Muller blades, they're called, and they're the stainless steel things that basically adult ones have been shrunk down to baby size and changed a little bit. They're not very good. And when you've got a newborn baby who's struggling to breathe, the mother's there obviously upset, so the father's probably there and you're trying to get langoscope down their throat, it's not a great, it is a very stressful situation, so he's kind of developed a, trying to develop a better one, right? Even the simple things. These things are made of stainless steel and you put a piece of metal on a baby's tongue. A newborn baby's obviously never experienced cold before, so they obviously start freaking out and squirming and you're trying to get this thing down her throat. It's crazy. So I'm helping him to see if he can come up with a better solution. He's got a, got an idea at the moment. He's developed some prototypes and we're gonna help him get it, see if we can get it a bit further along, and hopefully get to the market and solve this real small unmet clinical need, but really important one. [00:19:16] Lindsey Dinneen: Yeah. That's incredible to hear about both of those stories. That is really exciting. I love I-- this is partly why I love this industry so much is the innovation coming out of it is always amazing. People care so deeply about making a difference and improving patient outcomes, and then to hear about those kinds of innovations, ugh, that's awesome. [00:19:38] Stuart Grant: Yeah. Yeah. So if there's any experts out there listening who wanna get involved in the N-H-S-C-E-P program, I know Australia does one too. So yeah, get involved and share your knowledge freely to some clinicians who wanna, who have found an unmet clinical need and wanna solve it, but don't know how to. [00:19:56] Lindsey Dinneen: Yeah. Love it. That's fantastic. So it, it seems like, you know, from your career trajectory and your continuing education all this time that you are not someone who sits still very well. And I think you mentioned this a little bit in your LinkedIn profile, you like to keep moving. So one of the things that I noticed that you do, and I'd love if you share about it, is you do lectures on the history of innovation. Could you share a little bit about that? [00:20:24] Stuart Grant: Yeah. So. I I really, so I sort of got into reading about innovate. I love reading innovation books, right, nonfiction, innovation books, which I got in about 10 years ago. I read probably one of the first one was "The Idea Factory," which is about Bell Labs. And that was how Bell Labs has invented the telephone system and invented the transistor, won a load of Nobel Prizes. Shockley and Bardine were there. They just had this crazy Medici effect going on in Bell Labs. The Medici effect when you collect everybody together in a small area and they just start bouncing ideas and coming up with some hugely creative solutions. And that comes from Florence when DaVinci and Michelangelo and Raphael were all kicking about Florence and they were all paid for by the Medici family, so this why it's called the Medici. There's a book about it actually called "The Medici Effect." So I started reading all this and started just going backwards in history and getting to the industrial revolution and how the industrial revolution happened. And going further back to these group of men called the Lunar Men who were in Birmingham here in the UK who basically, it was James Watt, who invented the steam engine, Wedgewood, who was the pottery guy. It is Rasmus Darwin, who was Charles Darwin's great-grandfather. Yeah. All these people, they were called the Lunar Man 'cause they met every month in the full moon and discussed ideas and I think probably got drunk. [00:22:00] Lindsey Dinneen: I mean... [00:22:03] Stuart Grant: So yeah, I just love reading it and you know, I love, I'm now a little bit of a brag. As of last month, I'm a fellow of the Institute of Mechanical Engineers, and that is quite prestigious that was created by George Stevenson, and George Stevenson was the guy who created the steam train. [00:22:23] Lindsey Dinneen: Okay. [00:22:23] Stuart Grant: So we took Watts' idea of the steam engine, put it on wheels, figured out how to work. And I love, I just love steam trains and that's very dorky of me, I know. But I love, as a mechanical engineer, just seeing all the bits move and actually seeing them chug around all the noise and the steam. And here where I live in Yorkshire, in the UK, up the road in York is the National Railway Museum, which all the steam trains are at. Darlington is west. George Stevenson had his the original railway, the Darton Stock Railway. So George Stevenson created the Institute of Mechanical Engineers 'cause he was a mechanical engineer and his son created the rocket the first really fast once, Robert Stevenson. So learning all this and then figuring out how, then I went back-- I'm, so this is a long answer to your question-- then I went back went back and like understood why the industrial revolution happened and it was all about the banking system here, how people could get capital. And then the legal system grew up to protect that capital. And then agriculture improved in the UK so people weren't just stuck on farms, subsistence farming. There was enough food being produced to support the population so the population could go and work in factories and obviously James Watt creating the steam power created more power. So people in horses and everybody didn't have to work so hard. And then there was politics involved with the Hugonos, which were the Protestant, the French Protestants came over and they had all, they had the ability to make all these machine parts, 'cause that's our skill. Some of them came to the UK and the others went to Switzerland. And that's where the watch industry in Switzerland created. And then, you know, and then the scientific approach and the enlightenment came in the UK and it all just sort of bubbled up into the industrial revolution and then cascaded through the 19th century and the 20th century in. Here we are in the 21st century. So I just love knowing that whole pathway of somebody said "We need more legal," and then somebody said, "We need more banking" and as startups, right, investment is the king. So it all started 300 years ago with the UK banking system. [00:24:35] Lindsey Dinneen: Fascinating. Oh my goodness. That is so interesting. Yeah. Okay. One other interesting thing I caught from your LinkedIn profile is that you are a painter, but you are an exhibited painter, yes? [00:24:51] Stuart Grant: Yeah, I, well, I try. [00:24:54] Lindsey Dinneen: Okay. [00:24:54] Stuart Grant: So yeah. Obviously I did product design right? And I did product design because at school, I was good at art and I was good at maths and physics. So I was looking around going, "What discipline do those three things fit together?" And it looked like it was product design. I was like, "Okay, I'm half an engineer, half an artist, not good at either." So about 10 years ago I decided to pick up art again. It was, started to go to classes and doing landscapes and actually sadly the industrial decline of Britain's, so the old buildings of the industrial revolution and stuff like that. So I paint that stuff. [00:25:36] Lindsey Dinneen: Oh, that's so cool. [00:25:37] Stuart Grant: Put it into exhibitions and sometimes get rejected, sometimes get accepted, and try and sell a couple so I can at least call myself an artist. [00:25:45] Lindsey Dinneen: There you go. I love it. Yeah. Well, and that creativity and that artistry does, you know, impact your work in general, because I think sometimes having that outlet actually spurs some just creative solutions outside of the box that, you know, might have not come to you immediately if you were just like, you know, head down, really working hard on this project. And then if you could take a step back do you feel that it helps you in that way at all? [00:26:15] Stuart Grant: Yeah. Yeah, it definitely does. Not thinking about work is and just having it percolate in the background and not actually, 'cause it's a very slow deliberate process painting, right? So it does, you just lose hours and hours painting something, which is really nice. Obviously I've got a, I've got a 5-year-old at the moment running around, so I don't do that much painting. I usually just reserve it for when I go to my art class on Wednesday nights 'cause trying to focus is not a thing for a 5-year-old. [00:26:46] Lindsey Dinneen: Yeah, That's fair. Okay. Well, all right, so pivoting the conversation just for fun. Imagine that you were to be offered a million dollars to teach a master class on anything you want. It could be within your industry. It also could be your history of innovation, but what would you choose to teach? [00:27:08] Stuart Grant: So I thought about this when you gave that question because I was like, "Well, I've already talked about the history of innovation and that can pretty boring." So my other boring side, when you do a PhD, you always wish you did another subject. That's the thing is like, I wish I studied that instead. So my, as you go through the PhD, you learn other things and you're like, "Oh, that's really interesting." And you go down rabbit holes and you're like, "Oh, well stop. That's not my job. That's not what I'm trying to do here." One of the ones was how technology and society are interlinked. So technology drives society, and we've got lots of examples of that. Steam engines, trains, telephones, electricity, light bulb, broadband, and now AI. And so technology affects society. Then society drives technology. They're a virtuous circle. Some people say it not virtuous at all, but they, that's what happens. And understanding how those two things, society and culture and technology all interact is really interesting to me. And obviously not all technologies are adopted. Some are abandoned. Sometimes the better technology is abandoned for an inferior technology for lots and lots of reasons. There's examples. In the eighties, it was VHS and beta max, Blu-ray and HD DVDs. And what else? The keyboard, QWERTY keyboard is meant to be terrible. And that was designed 'cause of typewriters at the time. So the keys didn't smash together, but obviously that's not needed anymore. So those things interest me and I like to study that more, but I like to study it. Thinking about medtech and how our technology in medtech has affected society and using that lens 'cause we also always talk about clinical needs, right? What's your unmet clinical need? What are you trying to solve here? But there's also a social and cultural need that you are maybe not addressing directly, but you are addressing it. And how that drives medtech, and you know, it's we talk about like medtech equality and democratizing medtech and making it more accessible, but there's always the flip size of medtech inequalities. The big one probably at the moment is robotic surgery. Hugely expensive. Only available to very few. So how will that filter through society? How does that affect society? Will it just be for the rich developed countries to use robotic surgery? How will that affect it going forward the next 10, 20 years? Because it uses a capital equipment, right? They can't be diffused through society very easily. So that, that's one thing I would like to study and sort of talk about a little bit more, 'cause I think it's really interesting, especially now AI is being talked about and how digitizing healthcare is gonna happen over the next decade. Interesting if we're overclaiming that at the moment and a lot of startups are overclaiming, what they can really do and is it gonna, is there gonna be a backlash? Who knows? Let's see. In our, maybe in a decade, I'll present a course on it. [00:30:23] Lindsey Dinneen: There you go. Okay. And time will tell. Alright. I like it. Very cool. Okay. And how do you wish to be remembered after you leave this world? [00:30:34] Stuart Grant: Yeah. My PhD was like, I would probably like, I'd like to remember my PhD findings, but I'm like, no, who cares? [00:30:44] Lindsey Dinneen: Oh. [00:30:45] Stuart Grant: I, I've got, of course, my family, making an impact on my, what I've done here with my family, but, and I was really thinking about this question earlier. I was like, "Well, I hope this isn't the end. I hope I haven't peaked." [00:31:02] Lindsey Dinneen: Yes, that's fair, okay. [00:31:06] Stuart Grant: So maybe the next 20, 30 years, hopefully I'll be remembered for something, I hope. [00:31:12] Lindsey Dinneen: Okay. To be determined. I like that. I like that a lot all right. [00:31:18] Stuart Grant: It's a positive. [00:31:20] Lindsey Dinneen: Yeah. It's, and it's a forward way of thinking that, you know, you don't have to limit yourself to what you've already done or accomplished or seen. Who knows? The world is exciting. Yeah. I like it. Okay. [00:31:33] Stuart Grant: Well, yes, I'm yeah, definitely. [00:31:35] Lindsey Dinneen: Yeah, all. [00:31:36] Stuart Grant: One of the things we're doing-- I was looking at the Australian MedTech market and really just trying to figure out what's going on to see if there's anything I can do there. And talking to my wife, we decided, 'cause my daughter's not at school yet, we decided, "Let's go to Australia for an extended holiday." And it was gonna be like a month and we'll start working it all out, like we're just gonna go for three months, March, April and May this year, to sort of experience Australia, experience the MedTech market, go meet a lot of people, understand and just sort of grow and try to understand another way of people. I know Australia, they've got a similar culture to the UK and the US. But they do, they are far away. So they have a different take on things. And I wanna see what a difference is and see if I can get involved. So we're off to Australia on the MedTech market, so if anybody's listening, reach out to me on LinkedIn. It'll be we'll hopefully when I'm over there, we are in Brisbane. We can meet up. [00:32:32] Lindsey Dinneen: Excellent. Yeah, no, that's really exciting. And I actually have a few people I can connect you with as well, so, yeah. Okay. And then final question. What is one thing that makes you smile every time you see or think about it? [00:32:48] Stuart Grant: Oh. I think it's, it is back to my old answers, it's back to the steam trains. I just love watching the mechanism going around. My, me and my daughter who's exhibiting engineering characteristics, shall we say. Love, we love going to the railway museum and running around 'cause you can go and touch the trains, you can get on them, you can get your hands greasy if you want to, if you touch the wrong bit of it. She loves seeing them. And they're just, so when these engineers designed all these big bits of metal, they didn't have FEA or CAD or anything. They just sort of took a guess at the curves and how it should look. And some of these parts they designed are so beautiful when you start looking at them, it just makes me smile, like there was a person, a man, we'll have to say a man, right, 'cause it was 200 years ago... [00:33:44] Lindsey Dinneen: Right. [00:33:44] Stuart Grant: A engineer who decided he was gonna make it like that out of wood. And they were cast into iron and they just they were just sitting in their shop and just did what they thought was right. And most of the time it didn't break. [00:34:00] Lindsey Dinneen: Most of the time. There you go. Yeah. That's great. I love that. Well this has really been a fantastic conversation. I'm so grateful for you joining me today and sharing just some of your history and you know, what you're looking forward to next. I think it's, I think it's really incredible when you get to combine all the different things, like you said. You've got sort of that design and problem solving and you've got the engineering and you've got all these cool things that just make you an incredible help to the MedTech industry. And we're excited to be making a donation on your behalf, as a thank you for your time today, to Sleep in Heavenly Peace, which provides beds for children who don't have any in the United States. So thank you for choosing that charity to support. Thanks for joining and thanks for everything you're doing to change lives for a better world. [00:34:52] Stuart Grant: Yeah, thanks, Lindsey. It's been a real pleasure talking to you. [00:34:55] Lindsey Dinneen: Yeah, absolutely. Thank you again. [00:35:00] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world.

Do you actually have an export strategy or just international ambition?In this episode, Hakeem breaks down the five-step commercial system that turns export from a hopeful expansion into a revenue-driven growth plan. Because export rarely fails due to market difficulty, it fails due to lack of structure.If you're a clinician-founder building a Medical Device business, this episode will show you how to stop drifting between markets and start executing with clarity.Learn the 5-step framework to build a structured, revenue-led export systemDiscover how to prioritise markets using probability and potential (not attention and hype)Understand how to engineer distributor behaviour and adoption triggersHelping clinicians simplify their go-to-market strategy so they can stop guessing and turn their working prototypes into international MedTech businesses.Hit play now to build an export plan that survives commercial pressure.Message me via DM on LinkedinBook a 30 min discovery call for the Healthcare Export Accelerator ProgrammeThis podcast is for clinicians turning medical devices into real businesses, with practical insight on go to market strategy, exporting, and scaling in international MedTech.

In this episode of Disruption/Interruption, KJ sits down with Gennadi Seko, founder and CEO of Oxilight, who is revolutionizing wound care diagnostics by transforming smartphones into powerful medical imaging devices. Gennadi shares his personal journey from Bay Street finance to medical physics, driven by his grandmother's diabetic foot amputation. He discusses how his company is disrupting the medical device industry by making diagnostic technology portable, affordable, and accessible—moving critical wound care assessments from expensive hospital labs to patients' homes. This conversation explores the intersection of deep tech innovation, healthcare accessibility, and the power of multimodal diagnostics in saving lives and limbs. Four Key Takeaways [26:19] Multimodality is the Game Changer - Instead of multiple expensive single-purpose devices sitting on shelves, combining three technologies (multispectral imaging, fluorescence imaging, and thermal imaging) into one $200 smartphone attachment provides a 360-degree view of wound health and dramatically improves diagnostic specificity. [9:29] The Diabetes Crisis is Escalating - 27% of seniors (65+) in the United States have diabetes, and the disease is now affecting people as young as 25. Diabetic foot complications account for 80% of all non-traumatic amputations, making early detection critical. [21:44] Mobility Saves Lives and Money - Moving diagnostic technology to patients' homes solves the compliance problem and enables early intervention. Preventing one amputation saves healthcare systems 10x in costs while dramatically improving patient quality of life. [14:50] Physiological Imaging Beats Anatomical Measurement - Traditional wound measurement with rulers only tracks size over time, requiring multiple visits. Physiological imaging provides immediate prognostic information from a single snapshot, identifying whether a wound will heal normally or requires intervention. Quote of the Show (23:27): “I don't want to improve hospital healthcare. I want to improve healthcare in general." - Gennadi Seko Join our Anti-PR newsletter where we’re keeping a watchful and clever eye on PR trends, PR fails, and interesting news in tech so you don't have to. You're welcome. Want PR that actually matters? Get 30 minutes of expert advice in a fast-paced, zero-nonsense session from Karla Jo Helms, a veteran Crisis PR and Anti-PR Strategist who knows how to tell your story in the best possible light and get the exposure you need to disrupt your industry. Click here to book your call: https://info.jotopr.com/free-anti-pr-eval Ways to connect with Gennadi Seko: LinkedIn: https://www.linkedin.com/in/gennadisaiko/Company Website: https://oxilight.ca How to get more Disruption/Interruption: Amazon Music - https://music.amazon.com/podcasts/eccda84d-4d5b-4c52-ba54-7fd8af3cbe87/disruption-interruption Apple Podcast - https://podcasts.apple.com/us/podcast/disruption-interruption/id1581985755 Spotify - https://open.spotify.com/show/6yGSwcSp8J354awJkCmJlDSee omnystudio.com/listener for privacy information.

Industrial Talk is onsite at MD&M West and talking to Frederic Borne, VP at Resonetics about "Medtech manufacturing and microfabrication solutions". Fred Borne, a physics engineer and leader at Resonetics, discussed the company's expertise in medtech manufacturing, particularly in interventional cardiology, advanced diagnostics, minimally invasive surgeries, and bioelectronics. Resonetics specializes in microfabrication, including laser micromachining, and has expanded its capabilities through acquisitions, such as MemorySays for nitinol production. Borne highlighted the company's role in developing fiber optic sensors and implantable batteries, emphasizing their applications in neuromodulation and cardiac devices. He also touched on the potential of brain-computer interfaces and the future of neuromodulation technology. Outline MD&M West Event Introduction Industrial Talk, sponsored by MD&M West and the News and Brews team.Highlights the importance of MD&M West in delivering medtech automation, packaging, plastics, and design under one roof.Emphasizes the innovation, energy, and conversation at the event.Thanks the listeners for tuning in and celebrating the people driving industrial innovation. Welcome to Industrial Talk Podcast Scott reiterates the podcast's dedication to celebrating industry professionals worldwide.Encourages listeners to put MD&M West on their calendar for next year.Mentions the importance of meeting people like Fred Borne at the event. Introduction of Fred Borne Fred shares his background as a physics engineer specializing in fiber optics.Mentions his education at Laval University in Quebec City, one of the top photonics optics schools in North America.Discusses his career in fiber optics and the acquisition of memory says by Resonetics. Resonetics and Market Solutions Fred explains that Resonetics is a top 10 contract design manufacturing company for the medtech industry.Specializes in interventional cardiology, advanced diagnostics, minimally invasive surgeries, and bioelectronics.Highlights the company's expertise in microfabrication and the acquisition of memory says for the production of nitinol.Discusses the company's ability to provide micro components of nitinol, stainless steel, and other materials. Microfabrication and Medical Applications Scott and Fred discuss the concept of microfabrication and its applications in medical devices.Fred explains the use of laser micro machining for creating extremely small components.Mentions the company's ability to handle various materials and the importance of precision in their work.Discusses the challenges and innovations in the medical device manufacturing process. Fiber Optic Sensors and Medical Implantable Batteries Fred explains his role at Resonetics, managing the fiber optic sensors and medical implantable batteries divisions.Discusses the use of fiber optic sensors in blood pressure monitoring and other medical devices.Highlights the applications of fiber optic sensors in diagnostics and heart pumps.Explains the use of medical implantable batteries in cardiac applications and neuromodulation devices. Neuromodulation and Future Technologies Fred discusses the growing field of neuromodulation and its applications in medical devices.Explains the use of neuromodulation devices to treat conditions like urinary incontinence and asthma.Mentions the use of neuromodulation devices for sleep apnea...

You've come back from a medtech conference with five potential distributors. They all sounded good. Some were enthusiastic. One was keen. One asked hard questions.So who actually deserves your time in the next 30 days?In this episode, Hakeem walks through the real-world distributor scenario from the previous episode and breaks down why enthusiasm, speed, and confidence are often misleading signals. Instead, you'll learn how to identify execution capability before you commit time, energy, and commercial momentum.Learn how to distinguish between interest and true intent in distributor conversationsDiscover the early warning signs of misalignment that cost founders 6–12 monthsGet a practical 30-day framework to test real execution before signing anythingHelping clinicians simplify their go-to-market strategy so they can stop guessing and turn their working prototypes into international MedTech businesses.Hit play now to stop chasing noise — and start selecting distributors based on execution.Message me via DM on LinkedinTake the Export Readiness QuizThis podcast is for clinicians turning medical devices into real businesses, with practical insight on go to market strategy, exporting, and scaling in international MedTech.

In this episode of Medsider Radio, we sat down with Shaun Bagai, CEO of RenovoRx. The company is developing targeted oncology therapies and is currently commercializing RenovoCath, which is focused on pancreatic cancer. Before joining RenovoRx in 2014, Shaun spent over a decade in the cardiovascular space, including leading global market development at HeartFlow and helping establish the European renal denervation market at Ardian, which Medtronic acquired for approximately $1 billion. He began his career in clinical research and device sales at TransVascular and Medtronic. In this interview, Shaun discusses how testing markets with minimal infrastructure reveals what leads to commercial success, why clinical trial enrollment benefits from sales discipline, and what founders should understand about going public when traditional capital isn't available.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.And if you're ready to level up your medtech game, you should check out Medsider Courses — 8-week masterclasses covering topics like fundraising, M&A and exit planning, design and development, clinical and regulatory strategy, and commercialization.These courses, featuring hard-earned lessons from elite medtech CEOs, can be purchased individually or come free with our All-Access Pass.If you'd rather read than listen, here's a link to the full interview with Shaun Bagai.

Et si l'on pouvait sentir l'odeur des phénomènes physiques ? Détecter une anomalie avant qu'elle ne devienne critique, anticiper l'emballement d'une batterie ou suivre précisément les étapes de fermentation ?Dans ce nouvel épisode du Lab, Émilie Bialic, Data Scientist Senior chez Capgemini, nous explique comment le nez électronique, un dispositif inspiré de notre odorat et amplifié par l'IA, parvient à décoder l'empreinte olfactive des phénomènes physiques. Les applications sont nombreuses et prometteuses dans la santé, l'industrie ou encore l'agroalimentaire. À la croisée de la physique, de la modélisation mathématique et de l'intelligence artificielle, cette technologie apprend à reconnaître des signatures olfactives complexes pour révéler ce que le monde réel émet sans que nous ne puissions le percevoir.

In this episode, Duane Mancini sits down with Louise Yochee Klein to explore the fundamentals of fostering courage and innovation in the MedTech industry. Louise shares her journey from Canada to Philly, co-founding Courage Growth Partners, and emphasizes the importance of understanding and overcoming fear in business. The conversation highlights the critical need for aligning team objectives, adhering to detailed plans, and maintaining positive energy for personal and business success.Louise Yochee Klein LinkedInCourage Growth Partners Website“Courage to Champion” BookDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law and JumpStart Inc.

In this episode, Etienne Nichols sits down with Edwin Lindsay, a seasoned MedTech operator and QARA leader, to discuss the systemic challenges facing the pediatric medical device market. Following a personal experience in a neonatal ward, Edwin highlights the stark reality that many pediatric treatments rely on adult devices adapted off-label, often leading to safety risks and clinical inefficiencies.The conversation delves into the "mismatch" of the pediatric market: these devices require the same rigorous regulatory and quality standards as adult products but offer significantly lower financial upside due to smaller patient populations. This creates a barrier for investors and manufacturers, leaving clinicians and nurses to "work miracles" with tools that aren't always fit for purpose.Despite these hurdles, Edwin shares an optimistic vision for the future. He discusses his initiative to build a collaborative network of experts—including regulatory consultants, testing houses, and grant writers—willing to provide pro-bono or at-cost support for pediatric startups. The goal is to create a streamlined regulatory roadmap that prioritizes patient safety without the prohibitive costs that currently stall innovation.Key Timestamps00:45 – The "Pediatric Gap": Why pediatric devices have adult-level requirements but lower ROI.03:12 – Personal Insight: Edwin's experience in the hospital and the "Guinness philosophy" of giving back.05:30 – The danger of adhesives and adapting adult materials for newborn skin.08:15 – Building a pediatric volunteer network: Testing houses and consultancies stepping up.11:40 – Regulatory Roadmaps: Navigating the age variability from premature infants to adolescents.14:50 – Off-label usage risks and the "mindset shift" required for manufacturers.18:25 – Micro-timestamp: The FDA's Humanitarian Device Exemption (HDE) and P-Sub programs.21:10 – Real-world clinical friction: Alarm fatigue and sensor sensitivity in NICU settings.25:40 – The hidden costs: Manufacturing complexity, multiple SKUs, and low-volume production.Quotes"We need to give clinicians the correct tools to work their miracles. They don't want to use products off-label; they want devices actually designed for the children they are saving." - Edwin Lindsay"If you have a pediatric project, there is a community behind you. We are breaking down the barriers of risk and cost because these babies deserve a chance." - Edwin LindsayTakeawaysRegulatory Flexibility: Utilize specific FDA pathways like the Humanitarian Device Exemption (HDE) and the Pediatric Submissions (P-Sub) program to gain early feedback and specialized guidance.Collaborative Cost-Sharing: Seek out "altruistic" partners; many testing houses and manufacturers are willing to work at-cost or under different financial models for pediatric-specific innovations.Design for Sensitivity: Pediatric innovation isn't just about miniaturizing adult tech—it requires solving unique issues like alarm fatigue and skin sensitivity (e.g., non-damaging adhesives).Workflow Integration: Engage the "head nurse" early in R&D to ensure the device fits into the high-stress environment of a pediatric ward without adding to clinical fatigue.ReferencesFDA HDE Program: A regulatory pathway for devices intended for diseases or conditions that affect small populations.Greenlight Guru: The industry-leading platform for QMS & EDC solutions, helping MedTech companies maintain...

In this episode of Investor Connect, Hall Martin speaks with Nader Fathi, CEO of Enlil Technology, about the innovative strides his company is making in the MedTech industry. Based in Campbell, California, Enlil Technology emerged from the Shifa Fame Innovation Hub. Their AI-powered platform brings compliance, product lifecycle, and regulatory traceability into one unified system for medical device and digital health companies. Designed to reduce complexity and enhance operational efficiency, Enlil's platform streamlines processes from concept to commercialization, empowering MedTech companies to navigate FDA and other regulatory pathways efficiently. Nader delves into the genesis of Enlil, explaining how it spun out from the internal needs of Shifa MedTech's portfolio companies. Initially developed to aid in internal compliance and process management, Enlil was commercialized in early 2022 and has rapidly gained traction, adding over 34 companies to its user base. The platform leverages a proprietary AI called Lilly, which aids in search functionalities, report generation, and even automates critical tasks such as FDA submissions, significantly accelerating product development timelines and reducing costs. The conversation also highlights Enlil's go-to-market strategy, including their expansion efforts on the global stage. Despite focusing primarily on the U.S. market in 2022, Enlil has garnered international interest from countries like India, Singapore, and Japan. Nader emphasizes the necessity for startups to implement robust systems early to avoid scalability issues and successfully navigate the complex regulatory environment. Reach out to at nader@enlil.com ________________________________________________________________________ For more episodes from Investor Connect, please visit the site at: http://investorconnect.org Check out our other podcasts here: https://investorconnect.org/ For Investors check out: https://tencapital.group/investor-landing/ For Startups check out: https://tencapital.group/company-landing/ For eGuides check out: https:/_/tencapital.group/education/ For upcoming Events, check out https://tencapital.group/events/ For Feedback please contact info@tencapital.group Please follow, share, and leave a review. Music courtesy of Bensound.

You've booked the flights, paid for the stand, and printed the brochures but do you actually have a distributor strategy?In this episode, Hakeem breaks down why conferences so often fail to deliver real export outcomes for clinician-led MedTech companies. He reveals the old way of approaching distributor meetings (scattergun, vague, hopeful) versus the new way (focused, qualified, strategic), and gives you the exact questions you must answer before attending your next event.Learn how to define your distributor strategy before you show up at a conferenceDiscover how serious MedTech teams use conferences to execute, not exploreGet a practical framework for turning random interactions into real pipeline progressHelping clinicians simplify their go-to-market strategy, so they can stop guessing, and turn their working prototypes into international MedTech businesses.Hit play now to stop hoping conferences will save you and start using them to close distributor gaps strategically.Message me via DM on LinkedinTake the Export Readiness QuizThis podcast is for clinicians turning medical devices into real businesses, with practical insight on go to market strategy, exporting, and scaling in international MedTech.

SPONSORMedboard: https://www.medboard.com/EUROPE New Harmonization Standards -  Implementing Decision 2026/193: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202600193Neurosurgical implantsEN ISO 14155:2020 on clinical investigationsEN ISO 18562 series on Biocompatibility for Breathing gas pathways Germany: Transition from DMIDS to EUDAMED - March 19, 2026:https://www.bfarm.de/DE/Aktuelles/Veranstaltungen/Termine/2026-03-19-registrierung-mp.html?nn=986770EUDAMED mandatory by May 28th, 2026  High-Level Conference on Medical Devices - March 16th, 2026 - Brussels:https://health.ec.europa.eu/events/high-level-conference-medical-devices-innovation-and-patient-safety-16-march-2026-brussels-belgium-2026-03-16_enThe conference will feature three breakout sessions focusing on:Enhanced predictability for conformity assessments: combining certainty with flexibilityClinical evidence at EU level to support the regulatory framework: the key role of Expert PanelsBreakthrough technologies for better care: turning guidance into realityTeam-NB: Letter on Cybersecurity - MDR and IVDR proposal draft version:https://www.team-nb.org/wp-content/uploads/2026/02/Team-NB-Letter-on-cybersecurity-20260205.pdfSwitzerlandSwissmedic inspection on Importers -30 importers, 232 product samples, RESULT?:https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/infos/smc-ueberprueft-ch-importeure-2025.pdf.download.pdf/md-schwerpunktaktion-importeure-2025_en.pdf Swissdamed Webinar - May 28th, 2026:https://www.swissmedic.ch/swissmedic/en/home/services/veranstaltungen/swissdamed-webinar.htmlUKUK to exempt Health Institution - Not a priority for nowhttps://www.gov.uk/government/publications/health-institution-exemption-for-general-medical-devicesTrainingTeam-NB: Training on MDR technical Documentation - For manufacturers on April 19th, 2026:https://www.team-nb.org/new-session-mdr-technical-documentation-training-for-manufacturers/EasyIFUCreate eIFU and Labels easily - Compliance to EU MDR/IVDR:Https://easyifu.comRoWNorth AmericaFDA: General Wellness devices - Guidance by the FDA:https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-wellness-policy-low-risk-devicesFDA: Cybersecurity in Medical Devices - QMS and Pre-market submission:https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-medical-devices-quality-management-system-considerations-and-content-premarketAPACMalaysia: Electronic Certificates issued by MDA - For FSC, Manufacturing Certificates and Export Certificateshttps://portal.mda.gov.my/index.php/announcement/1746-implementation-of-electronic-certificates-for-certificate-of-free-sale-manufacturing-certificate-and-export-certificate-issued-by-medical-device-authority-mda-malaysiaIndia: Import of IVD - Online Portal: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTM4NDE%3DAfricaEgypt: Database for Product Registration -Online Electronic Service: https://eservicesdata.edaegypt.gov.eg/MedicalDevicesMiddle EastSaudi Arabia: SFDA inspection of QMS requirements - Process that would be followed:https://www.sfda.gov.sa/sites/default/files/2026-01/MDS-REQ10E.pdfPodcastEpisode 372 - How to remediate a Design History File (DHF): https://podcast.easymedicaldevice.com/372-2/Episode 373 - QMSR is coming: Why FDA inspections with change completely in 2026: https://podcast.easymedicaldevice.com/373-2/Episode 374 - Validation & Supplier Management in MedTech: https://podcast.easymedicaldevice.com/374-2/ServicesConsulting support: info@easymedicaldevice.comAuthorized Representative: EO@easymedicaldevice.comSocial Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldeviceThis podcast is powered by Podcastics, the easiest platform to create and publish your podcast.

In this episode, we explore why hyperconnected, orchestrated supply chains are critical, covering visibility, disruption management, talent, AI, collaboration, and how SAP and Deloitte help leaders modernize. Download the ⁠⁠⁠⁠⁠⁠episode transcript⁠⁠⁠⁠⁠ ===== This week we, together with Deloitte's Jagjeet Singh discuss the shift toward hyperconnected, orchestrated supply chains. They discuss today's top challenges - limited visibility, constant disruptions, and talent gaps - and how to break silos, align planning with execution, and use AI, control towers, and collaboration platforms to improve decisions. ===== Guest 1: Jagjeet Singh, US SAP Supply Chain Market Offering Leader, DeloitteJagjeet is a principal (equity partner) in the Deloitte US firm providing Consulting Services to clients in several industries including MedTech, Pharma, Consumer and Manufacturing. In his experience of more than 25 years, he has led global and complex enterprise transformation programs creating value for organizations through simplification, standardization, AI-enabled innovation and automation with SAP. He leads the US SAP Supply Chain market offering for the firm driving external relationships, internal talent enablement, and asset development for the supply chain domain. His end-to-end transformation expertise includes advising companies on implementing best business strategies to maximize revenue, minimize cost and improve margins. ⁠ Host 1: Richard Howells, SAP ⁠⁠Richard Howells⁠⁠ has been working in the Supply Chain Management and Manufacturing space for over 30 years. He is responsible for driving the thought leadership and awareness of SAP's ERP, Finance, and Supply Chain solutions and is an active writer, podcaster, and thought leader on the topics of supply chain, Industry 4.0, digitization, and sustainability. ===== Show Links: Deloitte: https://www.deloitte.comSupply Chain Management: ⁠⁠⁠⁠SAP Supply Chain Management⁠⁠⁠⁠ ⁠⁠⁠⁠SAP Insights: Supply Chain⁠⁠⁠⁠   Follow Us on Social Media  Richard Howells: LinkedIn, SAP Digital Supply Chain: LinkedIn   Please give us a like, share, and subscribe to stay up-to-date on future episodes!   =====  Chapters:   00:00:00: Intro00:01:25: Guest introduction00:02:19: Key 2026 challenges: visibility, disruptions, talent00:04:19:   What makes it difficult to react quickly and efficiently to disruptions? 00:09:06: Real impact of  internal silos and disconnected systems00:10:33: What leaders need: orchestration, risk mindset, and decision frameworks00:12:56: Using data and AI to automate and orchestrate end-to-end
00:16:36: Collaborating beyond the four walls and multi-tier visibility00:18:52:  Best practices & Quick wins: more agile and orchestrated supply chain00:22:00: How SAP and Deloitte partner on orchestration 00:24:32 What's the future of the supply chain?00:25:38: Outro

If you're a clinician building a MedTech business, the real question isn't just “Does my product work?” , it's “Can my business operate without me doing everything?”In this episode, Hakeem breaks down five key takeaways that will help you stop surviving loudly and start scaling smart. You'll learn how to fix the true bottlenecks in your business, free yourself from low-value admin work, and use virtual assistants not just to save money but to build an operating model that actually supports adoption, sales, and export.Learn how to break your business into 4 stages to identify where progress actually slows downDiscover the simple task audit that shows exactly what you should never be doing yourselfGet practical steps to set up lean workflows and delegate with confidence using VAsHelping clinicians simplify their go-to-market strategy, so they can stop guessing, and turn their working prototypes into international MedTech businesses.Hit play now to stop defaulting to hiring and start designing a business that scales without burning out.Message me for Virtual Assistant Recommendations via DM on LinkedinTake the Export Readiness QuizThis podcast is for clinicians turning medical devices into real businesses, with practical insight on go to market strategy, exporting, and scaling in international MedTech.

In this episode of Medsider Radio, we sat down with Justin Zenanko, co-founder & CEO of SynerFuse.SynerFuse is developing the e-TLIF procedure, which combines spinal fusion with neuromodulation by placing leads directly at exposed nerves during surgery.A certified public accountant and serial entrepreneur, Justin previously served as CFO and senior vice president of corporate development at Recombinetics, where he led fundraising efforts totaling $68 million.In this interview, Justin discusses approaching FDA interactions as negotiations, validating procedures with off-the-shelf components before investing in custom devices, and structuring private raises through investment banks to preserve control while delaying institutional venture capital.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.And if you're ready to level up your medtech game, you should check out Medsider Courses — 8-week masterclasses covering topics like fundraising, M&A and exit planning, design and development, clinical and regulatory strategy, and commercialization.These courses, featuring hard-earned lessons from elite medtech CEOs, can be purchased individually or come free with our All-Access Pass.If you'd rather read than listen, here's a link to the full interview with Justin Zenanko.

In this episode, Duane Mancini welcomes Aileen Helsel, Director of Innovation at Carilion Clinic, to discuss the exciting advancements in healthcare innovation in Roanoke, Virginia. Aileen shares her journey from academia to technology transfer and ultimately to her current role, emphasizing the transition from research to real-world application. They explore Carilion Clinic's unique position serving a diverse population, including rural communities, and how this drives impactful healthcare solutions. Aileen Helsel LinkedInCarilion Clinic InnovationDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law and JumpStart Inc.

In this episode, Etienne Nichols sits down with Dr. Kristy Katzenmeyer-Pleuss, President and Founder of KP Medical Device Consulting, to unpack the complexities of the medical device life cycle. The conversation centers on how manufacturers often overlook critical phases of a product's journey, such as transportation, shelf life, and the decommissioning phase, focusing instead solely on the point of patient use.Dr. Katzenmeyer-Pleuss highlights the significance of the upcoming ISO 10993-1:2025 standard and its renewed emphasis on life cycle-based risk assessments. She explains how the transition between global markets—particularly between the EU and the US—can lead to unexpected FDA deficiencies when manufacturers rely on justifications that worked for notified bodies but do not meet more stringent FDA testing expectations for reusable or in situ curing devices.The discussion concludes with actionable advice on early design decisions, such as narrowing down material suppliers and reprocessing options to reduce testing burdens. They also explore the critical need for cross-functional communication and quality system integration to ensure that learnings from one project or regulatory interaction are captured and applied across a company's entire portfolio.Key Timestamps01:45 – Introduction of Dr. Kristy Katzenmeyer-Pleuss and the mission of KP Medical Device Consulting.04:12 – Defining the Medical Device Life Cycle: Concept to decommissioning and the "hidden" phases in between.05:30 – ISO 10993-1:2025: The impact of the new biological evaluation standard on risk-based approaches.09:15 – Global Regulatory Discrepancies: Why a device approved in Europe might face hurdles at the FDA regarding "worst-case" testing.13:40 – Reusable Devices & Reprocessing: Managing the "permutation explosion" of cleaning agents and sterilization cycles.17:22 – Early Design Decisions: How limiting options in the IFU can significantly decrease your regulatory testing burden.21:05 – In Situ Curing Devices: The unique testing challenges of materials that change states during use.25:10 – Quality System Integration: Strategies for linking regulatory deficiencies and materials across multiple projects.Quotes"The life cycle is really the concept of the medical device from when it's a concept all the way through to the end where you are disposing or decommissioning... shelf life and transport are steps that usually don't get a lot of focus, but they are very important." - Dr. Katzenmeyer-Pleuss"You might have one device where literally they don't ask these questions at all, and then other times they're very, very picky... the longer you go in that process, the harder it is to pivot without spending a lot of time and money." - Dr. Katzenmeyer-PleussTakeawaysFront-load Risk Assessments: Don't wait for FDA deficiencies to consider how shelf life or reprocessing affects device safety; integrate these into the biological evaluation plan from day one.

Rachel Knutton, founder and CEO of Alluvia Studio, shares how a 30-year healthcare journey—from hospital marketing and public relations (PR) at HCA Healthcare to medical device commercialization, product launches, and sales—shaped her belief that everything in MedTech ultimately comes down to storytelling. Rachel explains how her “been there” experience in hospitals, cases, and value analysis environments helps her create messaging that's compelling, compliant, and built to endure. She also opens up about becoming an “accidental entrepreneur,” discovering unexpected fulfillment in leading people, and building an agency culture grounded in authenticity, humor, and joy.    Guest links: www.alluviastudio.com | www.linkedin.com/rachelknutton | www.linkedin.com/alluviastudio  Charity supported: Sleep in Heavenly Peace Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com.  PRODUCTION CREDITS Host & Editor: Lindsey Dinneen Producer: Velentium Medical   EPISODE TRANSCRIPT Episode 073 - Rachel Knutton [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I'm delighted to welcome Rachel Knutton. Rachel is founder and CEO of Alluvia Studio, a strategic medtech marketing agency based in Tennessee that supports some of the largest medtech brands in the world. Her experience in healthcare spans 30 years, including hospital marketing and PR for HCA Healthcare, as well as various roles in medical device commercialization, sales and marketing. Right. Well, welcome to the show, Rachel. It's so nice to you for having me. Of course. I would love if you would start off by just, uh, telling us a little bit about yourself, your background and what led you to medtech. [00:01:36] Rachel Knutton: Yeah, so I actually have a pretty interesting background and I bet I'll cover a little bit more of it as we go through the discussion, but currently I have an MedTech marketing agency. We have 16 employees. been in business technically since 2011, so 14 years. And just really focused on this industry. My path to getting into MedTech actually came through HCA Healthcare. I started working in hospital world back in 1996. And actually it was accidental. I, you know, I was pretty new outta school, a couple years outta school and I'd answered an ad and I dove right into a really exciting world. It's, you know, of course headquartered here in Nashville. Learned all about hospitals. I supported I think eight different hospitals at that time that were in region, the Nashville region, doing marketing and public relations, walked into my first open heart surgery case, helped feed employees at midnight, handled all kinds of interesting PR events because we're hearing Nashville, a lot of country music stars might get hospitalized. And I did that for about 10 years. And then I ended up moving into devices a recruiter, and it's when Kimberly Clark Healthcare had gone into the medical devices arena through the purchase of Ballard. so honestly I really didn't know much about it. But I had, you know, I did have my MBA, I had been working in healthcare, which sort of met the qualifications at that time. And I got a early start in marcom. Learned so much, got back into the hospital through that role from the other side of the coin and I had the chance to do product management, launch a product, and then I moved into sales and sold the product a whole bag and then got back into the hospital, you know, working through the whole value EIS ecosystem and working with physicians and being in cases. So it's been a very interesting path for sure. [00:03:37] Lindsey Dinneen: Yeah. Yeah. Thank you for sharing that. And so I'm curious about a lot of things, but I'll start with this. So what do you find are some of the differences and similarities between marketing and PR for the hospital side of things versus the device side of things? [00:03:55] Rachel Knutton: I mean, certainly I think PR piece is a much bigger aspect, the community aspect. Um. Every hospital is such an important part of the community. So there's a heavy weight there on that. And then of course, the regional aspect of it. So whereas in the device world, you know, all targeting like very large geographies, maybe either the US or outside of the US. And so in the hospital world, that tends to be more regionalized. I would say. That's like one of the big differences for sure. And then honestly, hospital world, it's more business to consumer. is a lot of physician related marketing as you're trying to drive preference to, you know, using your hospital for surgeries or trying to recruit physicians, but it's a lot more B2C in the, medtech world. world. [00:04:44] Lindsey Dinneen: Yeah. Yeah. So, okay, so you mentioned know, you responded to an an ad and that led you to was sort of like, well, a say, um, synergy, whatever you wanna say. that was was marketing and communications something that you always had a passion for or what led you to kind of pursue that? [00:05:05] Rachel Knutton: Yeah. Well actually I was a little bit more of a writer. would say telling stories is origin story. So I wanted to work in magazines. This is back when we still did print and newspapers and things like that. And always wanted to work in the magazine um, industry and I, and it started out writing for a business magazine. Started working for an agency for Ford, doing writing for a sales focused magazine. And so it just sort of morphed into that. I would say in the marketing and PR world, we were telling stories about patient stories, pitching those to newspapers. We were telling stories about physicians doing new types of procedures employees, you know, trying to promote them within the hospital world. That's also important to that ecosystem. And so I think that's kind of where that transition happened. And I would say that's still what I do today. So it's taken a lot of different forms and product management and working in Excel files and figuring out demand forecast isn't really about telling stories what it is, right? Everything is about telling a story in the end. [00:06:06] Lindsey Dinneen: Yeah. Yeah. So it sounds like you have the strategist side, the analytical side, and the creative side, which doesn't always, you know, align. And so tell us a little bit about your approach maybe to, say, there's a client of yours that is interested in bringing a product to market, and story tell to help them achieve their goals, and within compliance, because obviously that's a component. [00:06:35] Rachel Knutton: yeah, I mean, that's certainly in our industry, you know, figuring out are the guardrails. course in marketing, I always think, you know, we, know the rules. But we're also going to make sure that we're not self-limiting within those rules. So I let the regulatory people and the legal people push back. But I know what not to risk, right? So I think one of the things that's very helpful is having sold devices, having launched devices myself, having worked in the hospital system, I spent a lot of time on the floors watching how devices are used. I spent time in ICU collecting data. I think really having been part of that environment helps feed the story building process. It's almost like a natural part of what goes into building that story. So because of that experience, because I've walked those halls, I've been in those shoes, I kind of know what some of those limitations are and that just automatically configures into the storytelling process. I know what the product managers are up against when they're trying to launch a product. And theoretically, I should know the right questions to ask and how they got to the product that they have today and how they've, you know, customer feedback has fed into that. And then how do we take that and make sure that the messaging meets the same requirements? Like you have a, you know, you have design requirements, well, your messaging should have the same requirements and achieve a goal. So I think that's the analytical side is making sure, does the message achieve the goal? Are we being very committed to what's the business objective? How is the marketing objective supporting that? And then is the, how is the messaging fitting into that? I think that's a very important part of the discipline. We also are very familiar with, you know, claims matrices and the importance of having, you know, data and research to support claims. And so kind of knowing that framework, I think is helpful when you're building messaging because helps you think through like, okay, here's how the client is going to need to organize the messaging. Here's how they're gonna have to reuse the messaging. You know, how can we be very consistent in how we roll that out so they're not having to go back through and through their approval process every time. It's really important part of the discipline in the medtech world that we have to deal with that industries as well, of course, but it's certainly very important in ours. [00:09:01] Lindsey Dinneen: Yeah. Yeah. I, I really appreciate that insight and I think, you know, it's so interesting to see-- you're totally speaking my language about the consistency of, it's something I've, I've preached so much is you have to be consistent with your messaging and your branding. And it's not like everyone has to have the same cookie cutter language, but when you're aligned, that really translates. [00:09:25] Rachel Knutton: And it works. this is, you know, I, think this is a little bit of a, it's not a pet peeve, it's a passion project rather of mine is to get people to be consistent because I think what happens is internally, people get tired very quickly of their messaging or their creative. And I do think you need creative variability. We know with AI you need some of that, like that's gonna be important. But probably your customer, your target audience isn't tired of it and they might not have even seen it yet. And it's that very old, like nine times someone has to hear a message. And so my favorite clients are the ones that work very hard to get the messaging right in the first place. They go through the discipline process of doing it, knowing why we're doing it, getting full buy-in from an extended team, and then just keep with it, with some obviously refinement and tweaking when you get customer feedback. But you know, sadly, I'm sure we've all had this instance where it's like, "Oh, Dr. like this ad. We need a new ad campaign." And it's like, "Well, that's okay. I'm really glad he noticed it." You know? That's all right. That, might be okay. So, it, I think that the best companies are consistent and, you know, one of our clients is um, intuitive Surgical, and one of the things that we see is like, of course there's fresh creative. Of course there's brand evolution, but the overall message is very consistent and that's, it's fun to see how fruitful that consistency has been for them. [00:11:06] Lindsey Dinneen: Yeah, absolutely. Love that. So you worked for other companies and then you took a leap and became an entrepreneur and a leader of your business. What was that like? Were you prepared, so to speak? I'm not sure anyone's actually prepared to be an entrepreneur, but you know, how did that go for you? [00:11:24] Rachel Knutton: Yeah. was certainly an accidental entrepreneur. Some lifestyle choices, particularly marrying someone in the military at the time when we didn't do Zoom calls forced me to look at my career path and go, you know what? I'm not gonna climb the corporate career ladder moving. At that time, it wasn't a thing. And I thought, you know, I'm gonna need to do consulting in order to, you know, support family and then keep my business going. So I had lifestyle reasons that I became an entrepreneur and wasn't really sure how it was gonna work out, to be perfectly honest with you. And, you know, felt like a lot of people say, "Well, I'm consulting," which just means they don't have a job right now. And I, I know, you know, nothing bad about saying that, that can be very true, but for me, I was like, this is actually something I'm gonna need to do. And I did it as a as a solo consultant for several years, and then when I, we finally settled down and stopped moving said, "Well, it's time for me to get some help." The thing that was really interesting to me is I never really wanted to manage people even when I was in the corporate world, I just wanted to do great work. I wanted to, you know, I, felt like people slowed me down. You know, I just, I'm like, "Just let me go. I'm a star player." And it was really nothing that I was interested in at all. And now I have, you know, all these employees and I spend a very large portion of my time managing people. And the thing that has been so surprising is how gratifying that is, how fulfilling it is. One, to, you know, go beyond your comfort zone and find, I've learned so much. I've made a lot of mistakes. I've thought about other leaders that I've been lucky to work with in the past and follow what they do. And maybe some people who had some tendencies that I try not to do or I'll check myself and go, "Oh, am I, you know, am I doing that?" But I think managing team, developing people is the most exciting piece of it. always loved helping clients, so as I started out in this venture, I had a couple of offers to go work full time for those clients, but at that point I had been helping a few people and I was like, "Well, I can't say no to to the guy at this company, I can't say no to her because she needs my help. And if I have a full-time job, I'm not gonna be able to do that." So I really just wanted to help as many people as possible and I felt like owning my own business will allow me to do that. Now that I have a team, we are able to help so many more people and that is really gratifying. The other thing is. Where I am, my community is outside of Nashville and we're a micropolitan, which means we're kind of just far away for our commute to Nashville to be impractical. We have a local university here, and so one of the things I wanna do early on was work with the local university talent for people who wanna stay in this upper Cumberland area and have a great profession. And it's somewhat limited still. It is growing, but there's not a lot of big corporate jobs. So what I love to do is I bring that corporate experience into my small business in terms of professional development, evaluations, how we coach people. And then I try to get rid of all this stuff that I didn't really care about working in the corporate land, you know, and increased flexibility. Let's not have politics and things like that, and so that people can just grow and flourish. And so it is, I'm very passionate about it. I love helping clients and I love helping my team, and so it's really like the best of both worlds for me. [00:14:58] Lindsey Dinneen: Yeah. Excellent. So you have an interesting name for your company and I would love if you would share a little bit what led to that? [00:15:07] Rachel Knutton: Yeah. Thank you for asking about that, actually. So when I was the first name for my company was called Good Day Marketing, and when I realized I was really going to stay in medtech, at that time when I launched it, I was like, well, maybe I won't do medtech. Maybe I'll just do other marketing. I was like, "Well, medtech is where people want me. This is what I know. I have expertise. This is where I need to be." It made a lot of sense. I was like, okay, I need to rebrand, and I had gone through a period of testing. And so I'm a Christian and I'm familiar with scripture. You know, where you're like, you get refined in the fire, you're refined like silver and like gold. And I was like, "Okay, I need to have something about gold." And I discovered there's a type of gold called alluvial gold. And it's the kind of gold that you find in riverbeds. And soil in uh, riverbed is very, very rich because you have so much, you know, marine life and you know, plant life flowing over it, but then there's gold deposited there, and I was like, "That's we do, right?" Like when we're working with medtech companies, there's so much rich content, there's so much intelligence and innovation baked into what they're doing. Our job though, is to find the pieces of gold that will really help them tell that story and distill that, right? And like purify it. And it goes through a refining process to make sure the message is really clear. leave the extra behind. And then once we get it into a good spot, we shine it and we just like make the best part of that messaging, pull that forward. So it just made a lot of sense for the agency to be called Alluvia Studio. [00:16:42] Lindsey Dinneen: That's, that's perfect. That's such a great story too. I love the intentionality behind it and the thought process of it. Um. So yeah, so you have some core values with the company, and I'm assuming this also derives from yourself, and three me were the values of authenticity, joy, and humor. Can you speak to those and how you came up with that? [00:17:06] Rachel Knutton: Sure. Well, authenticity is, I, I just can't not be authentic. So one of the things you and I had talked about before is, I have a hard time talking about myself. just am naturally a little bit humble and I have to ask other people to tell me what I'm good at, right? And they're like, "Well, such a thought leader. You know what this industry so well, you're so great at telling this story." And I think just being able to say, "Hey, I don't know how to frame myself is something that's just innate to me." [00:17:40] Lindsey Dinneen: Hmm. [00:17:42] Rachel Knutton: I think I wanna work that way with people. It means that if you need to have a tough conversation with a client, you can have it. something doesn't feel right, I wanna pick up the phone and say, "Hey, this didn't feel right to me. I don't like how this conversation went. I don't like how this project's going 'cause I don't, I sense that you're dissatisfied, I wanna talk about it, I wanna understand it." from the client side, that's how authenticity works. And then with my team as well. So, for me, their personal lives are very important. I know we all bring our personal life into our work. If we say that we don't, we're lying. And so I ask that, you know, if someone's having a rough day or going through something as much as they're comfortable, at least just let us know so that other people aren't impacted by maybe, you know, a down day or, or take it personally because you know how we all do that, right? We read into it, go, "Oh, did I do something to upset them?" "No, I'm just, I'm not here today." And so I just think it's really important one, and I want people to feel comfortable with them, to feel themselves. And I think it helps with like diverse perspectives well. And then fun. So like humor, fun to me are lumped together and I just think when you have fun at work, you do your best work. And reminded of a couple of stories with our clients. So a lot of times we think in medtech, like everything's so serious. Everything, you know, and it is, it's a serious business. We're doing important things. There's nothing flip about what we do. However, we're all human beings. And we all need to have fun while we're working together. So we like our clients to have fun working with us, and I like sharing things that are fun about me. I had someone just this week who is from a very high level financial position in a big company comment that he loved that I had a roller skater in my LinkedIn profile. Now, I never would've thought that, right? I never thought that person would have really appreciated that, but that just goes to show that we all need to have fun. And even if we're working hard, we just like work hard, play hard, like let's just, and when we're stressed, let's just laugh it off and keep going. [00:19:58] Lindsey Dinneen: Yeah, and the joy aspect, just curious because that is, uh, the huge core value of mine, and so I would just love to hear your take on it. [00:20:06] Rachel Knutton: It is my purpose life. I have identified that. I got go through a leadership development class about 20 years ago with Kimberly Clark, and we identified our purpose, and bringing joy into other people's lives was mine and what that means for me-- it is funny, early on in my career I, didn't think I was gonna work in medtech. I thought it was more in like hospitality, tourism, something, you know, that's fun, you know, obvious fun. But what I really realized is that joy, um, joy comes from completing a project, feeling very good about what you do. We are often a very important part when people are presenting about themselves. So they do a lot of presentations. They're presenting to their boss or to a board. We wanna make them look good. We wanna make them feel very confident and relieving that stress is a joyful experience for them. So for me it's very personal. know, as much as we can, we want to help them feel that and experience that, and that comes down to how we communicate with them. You know, let's laugh a little bit. Our job is to look good. We, this business is not about Alluvia. This business is about you, and we are here to be a partner with you in that process. [00:21:29] Lindsey Dinneen: Yeah. Oh my goodness. Yes. That resonates very much. Um, yeah, so, you know, you've you've had an amazing career and you've worked, like you said, on the hospital side, you have had the device side and now your own business. Are there any moments along your journey that really stand out as affirming to you that "Yes, I'm in the right place at the right time?" [00:21:52] Rachel Knutton: Definitely. When I started my consulting business, I wasn't sure that I was going to be in medtech. So I had been in the hospital world for about 10 years and I had been in medtech for about 10 years, and I thought, "Well, am I supposed to be doing something different?" You know, that's that's a nice time to like, and my relationships and my reputation drew me back in. So it was almost one of those like. I'm meant to be here because I do have the experience that people value and I do have a way of thinking that's very helpful for people and it's a unique perspective that help. And so through my consulting business, I ended up launching two more products through very large publicly traded companies. And I thought, "Well, okay, obviously I'm supposed to be doing this." [00:22:48] Lindsey Dinneen: Yeah. Yeah. Excellent. Yes, and I think makes sense too because it's, it's also rather niche, you know? So, so having the skill sets really play a good part into-- it's, it's-- basically what I'm trying to get at is it's not an necessarily an easy path. So it's helpful to have had that background to, you know, you've got the communications and the marketing, but also the nitty gritty of, you know, I remember when I first joined, you know, somebody would say a sentence and it was like, half of it was acronyms and it was, it's just such a steep learning curve, [00:23:21] Rachel Knutton: Yeah. Mm-hmm. [00:23:21] Lindsey Dinneen: Yeah. [00:23:22] Rachel Knutton: It's, it really, and it still is. I mean, there's no way to know about every specialty in the world or all of the, you know, technical or clinical issues that our clients customers need to deal with. But being able to figure out which parts you need to understand and which you don't, I think is good. Like, what do you need to filter? do you really need to go in order to help them communicate their message is. Is helpful. And I think having that experience does provide that filter. And you know, it's funny because I was thinking about your podcast and I love what you're doing with it. Like I love that you're trying to shine a light on our community and it is about so many people trying to help people and save lives. And yes, I mean, I work so heavily with the investor community and startup community that sometimes it starts to feel a lot like it's about money. think money follows great ideas, right? Because there's an economic value to an innovation that's gonna save our healthcare system money, save lives and outcomes and, things like that. So I think it's all important. One of the things that I've thought about though is. Our unique position is we help people that help people save lives. So, you know, we are not on the frontline innovating new devices. We are not really on the frontline working with the patients. But if they don't tell their story, if there's not awareness of their solution, if it's not implemented correctly-- we think, I think a lot about that at the at the sales level, having been in, in those shoes-- if those things aren't done correctly, then the patient's not gonna be helped and making sure that we make that as easy as possible. people don't really wanna think about marketing, right? Like they wanna think about the clinical aspect. They wanna think about the innovation and the know, technical issues that they need to solve. And new product development, but the marketing piece is really important. All [00:25:28] Lindsey Dinneen: Yeah. Yeah, and it's just a fun, well, it's really a special role to play, I think. And I've always felt really grateful for that because, right, if somebody doesn't know that it exists, then they can't buy it. And so even though my role is small in comparison to maybe the scientists and the engineers and everything like that, I still get to play a part, and I think that's just delightful. Yeah. [00:25:55] Rachel Knutton: Yeah. Yeah, it really is. And it's really helpful too. So, you know, running an agency, I have a lot of creative people. Well, in our industry, we don't get to be quite as creative as other industries, right? Because as you mentioned, you know, we have regulatory reasons and it's a slightly more conservative industry for sure and should be. We're always looking to figure out how do we inject that joy? How do we inject that fun and authenticity into something that still feels as professional, as innovative, and as buttoned up the product is, as the quality process has been, as the clinical study has been, but still, how do we have a unique voice within that? And so that's really helpful with my creative team too, to say, right, like our guy boundaries are a little bit different, but what we're doing is so much more important than selling a consumer product. Maybe like a luxury item or jewelry or marketing a, I don't know, something sexier, you know, like a vacation. I don't know. To me that'd be like the ultimate, send me around the world and have me market a travel. That'd be very good. [00:27:05] Lindsey Dinneen: You go. [00:27:06] Rachel Knutton: But at the end of the day, like it, it's making a really big impact and I think that's really helpful to help people in that. We're always looking for ways to try to get that experience. Like I'm always looking for ways to get experience from my team to be able to do that. I think that's probably my next big goal is like, how do I get them into the hospital? How do I expose them to what the day-to-day life is of a sales rep? You know? think that's really important in our industry to have some sort of exposure to feed on the streets in the hospital setting, how it works, what the sales rep has to go through to get the product implemented, how long it takes for it to actually succeed, right? Because it's not just one sale, it is a long process, a long journey, and an ongoing journey to make sure that that it sticks and that people understand how to use it. And I think having that like empathy or at least point of view can be really helpful to anyone marketing in our industry. [00:28:10] Lindsey Dinneen: Yeah. Yeah. I I really like that. That's, that would be a really helpful thing for anyone, especially if they're newer to the industry, to have that sort of boots on the ground, this is what it's actually like, kind of experience. [00:28:24] Rachel Knutton: Yeah. [00:28:25] Lindsey Dinneen: So, okay, so pivoting the conversation just for fun. Imagine that you were to be offered a million dollars to teach a masterclass on anything you want. It could be within your industry, doesn't have to be, what would you choose to teach? [00:28:39] Rachel Knutton: I think it would really be about this, like how to find joy. Like how to find joy in everything. You know, how do you cultivate a joyful outlook on life so that even when you're sitting in traffic or doing something you don't really love to do, how can you integrate that? You know, I think that one thing that's really important to me is my faith. So my values, I'm, Christian, and I really believe the only true joy that we have is when we have a relationship with Jesus Christ. And so that's not part of my business, that's part of my life mantra, but like if I could help people get to the real joy, that would be like the ultimate goal, right? If I can't get them there, if I can get them to, you know, experience joy in the day to day or experience joy in their trials, think that would be something worth, I'd do it for free. I don't even need a million dollars. a million dollars would be great. [00:29:34] Lindsey Dinneen: Yeah. Right. Excellent. Excellent. Yes. Okay. And then how do you wish to be remembered after you leave this world? [00:29:43] Rachel Knutton: I think it's that point I just made there, right, is that, maybe, I mean, it's so cliche, but I left things better than I found them. I left people better than I found them. And, you know, and ultimately, you know, if I lead them to Jesus, that is like the ultimate goal for me as a Christian. So for me, that would be a metric that if it was, you know, one person, if it was 1 million people, it doesn't matter. That's the goal. [00:30:13] Lindsey Dinneen: Yeah. Yeah. And then final question, what is one thing that makes you smile every time you see or think about it? [00:30:22] Rachel Knutton: It is my business. It really is. I mean, okay, obviously my family and my pets and things like that, but I really love coming to the office. This, we have our own building. Every time I come here, my spirits are lifted. I love seeing my team members and I love working with the clients and just hearing from them and building those relationships. Everything about this is so deeply personal to me that the money piece of it is like the very last thing that I think about. It's the last way that I run my business. It's the last way that I measure success. It's the last way I hire. It is really just follows that, that positive feeling of making an impact and having fun. I, it's just, I know it sounds crazy. We keep saying that, but I think it's really fun to do what I do. I'm [00:31:18] Lindsey Dinneen: Yeah. I love that answer. That's that's wonderful. And it, I think that's one of those affirmations that yeah, you are in the right place at the right time because you're having fun and you're joyful. I love that. [00:31:30] Rachel Knutton: Sometimes it's temping to work from home, and then I work from home, and then I come to the office. I'm like, "Why did I wanna work from home? It's so much lighter here. We have a disco ball here and I don't have a disco ball at home." [00:31:40] Lindsey Dinneen: Oh. Brilliant. I love it. Oh my goodness. Well, this has been such a fantastic conversation, Rachel. I so appreciate you and your time today, and I love the way that you bring joy and fun into medtech and into the lives of the people that you touch. And we're excited to be making a donation on your behalf, as a thank you for your time today, to Sleep in Heavenly Peace, which provides beds for children who don't have any in the United States. So thank you for choosing that charity to support. Again, thank you so much for everything you're doing to change lives for a better world. [00:32:18] Rachel Knutton: Thank you. This is a great interview, so I appreciate it. You made it easy. [00:32:23] Lindsey Dinneen: So glad to hear that. Alright, well thank you so much again, and thank you also to our listeners for tuning in and if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two and we'll catch you next time. [00:32:40] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world.

If you think scaling means hiring fast and locally, this episode will make you think again.Hakeem is joined by Bob Lachance, founder of REVA Global Med, to explore how virtual assistants and lean operational systems can help clinician-founders grow sustainably — without burning out or bloating the business. This episode isn't about outsourcing for the sake of cost-cutting. It's about fixing bottlenecks, building reliable processes, and designing a business that scales without you doing everything.Learn how to separate clinical work from clerical work — and why it's essential to scalingDiscover the 4-phase framework for identifying operational bottlenecks in your businessGet real-world strategies for building a virtual team that increases margin and capacityHelping clinicians simplify their go-to-market strategy, so they can stop guessing, and turn their working prototypes into international MedTech businesses.Hit play now to stop surviving loudly — and start scaling intentionally.Message me via DM on LinkedinBook a 30 min discovery call for the Healthcare Export Accelerator ProgrammeThis podcast is for clinicians turning medical devices into real businesses, with practical insight on go to market strategy, exporting, and scaling in international MedTech.

Validation is a cornerstone of medical device compliance — yet it remains one of the most challenging areas for manufacturers. In this podcast episode, Simon Foeger, Founder of SIFO MEDICAL, shares real-world experience and practical guidance on validation, risk management, and supplier development.Key topics discussed include:Test Method Validation: definition, regulatory expectations, and when it is requiredFDA warning letters and the risks of non-compliant validation approachesCommon pitfalls and best practices for Test Method ValidationProcess Validation and Packaging ValidationThe role of statistics in MedTech, including sample size justificationRisk management linked to validation activitiesSupplier management, from sourcing components to audits and long-term supplier developmentSimon also explains how SIFO MEDICAL supports medical device manufacturers through consulting and online training focused on:Process validation and equipment qualificationTest Method Validation trainingISO 13485 and 21 CFR 820.30 complianceSupply chain development, including injection molding and cleanroom manufacturing environmentsThis episode is essential for quality managers, regulatory professionals, validation engineers, and MedTech manufacturers looking to strengthen compliance, avoid warning letters, and build robust validation strategies.Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.LinkSimon Foeger Linkedin: https://www.linkedin.com/in/simonfoeger/Social Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldeviceThis podcast is powered by Podcastics, the easiest platform to create and publish your podcast.

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The University of Galway has today launched its new Medical Device Prototype Hub, supported by medical device company Medtronic. The development of the facility is part of the five-year €5 million signature innovation partnership between Medtronic and the University, announced in 2023, which focuses on three pillars: developing the MedTech ecosystem, STEM engagement and research. President of University of Galway, Professor David Burn, said: "The launch of the Medical Device Prototype Hub at University of Galway marks a hugely significant milestone in our signature partnership with Medtronic but it also sends a strong message to all those in the sector and all those who are driving innovation – University of Galway is creating the ecosystem in which our partners in research and innovation can thrive. We look forward to celebrating the breakthroughs and successes that this initiative enables." Ronan Rogers, Senior R&D Director, Medtronic, said: "Today's launch of the Medical Device Prototype Hub represents an exciting next step in our long?standing partnership with the University of Galway. Medtronic has deep roots in the west of Ireland, and this facility strengthens a shared commitment to advancing research, accelerating innovation, and developing the next generation of medical technologies. We are proud to invest in an ecosystem that not only drives technological progress but also supports talent development. This Hub will unlock new avenues for discovery and accelerate the path from promising ideas to real?world medical solutions for patients." The Medical Device Prototype Hub forms part of the Institute for Health Discovery and Innovation, which was established in the University in 2024, as part of the signature innovation partnership. It will be further supported through collaborations with government agencies and industry leaders. The Medical Device Prototype Hub sits within the University of Galway's new Technology Services Directorate, which provides shared research infrastructure and technical expertise to underpin activities across both the Institute for Health Discovery and Innovation and the Institute for Clinical Trials, established in 2024 and 2023, respectively. The Hub will be further enhanced through partnerships with government agencies and industry leaders, creating a collaborative environment that supports translation, innovation, and regional growth in life sciences and medical technologies. The development is part of an integrated ecosystem at the University of Galway, which enables sustained, research-led development, further positioning Galway as the centre of Ireland's global MedTech hub and the University as integral to research for the public good on the world stage. Aoife Duffy, Director of Technology Services Directorate at University of Galway, said: "The Technology Services Directorate brings together key research facilities that support fundamental research at University of Galway. It aims to advance our research excellence by bringing together state-of-the-art core facilities and making strategic decisions on infrastructure and investment. The new prototype hub significantly enhances the innovation pathway available for the university research community and wider, and we look forward to working with Medtronic on this partnership". Professor Ted Vaughan, Director of Institute for Health Discovery and Innovation (IHDI), said: "The Medical Device Prototype Hub will serve as a central core facility, providing the engineering infrastructure and expertise to design, build and test new devices. It adds to the vibrant healthtech and medtech ecosystem in the west of Ireland and provides fertile ground to drive its growth. "Our vision is to make sure we have the best possible conditions for the R&D of new technologies for healthcare. Our aim is to address remaining gaps in the development pipeline, from discovery to innovation." The Medical Device Prototype Hub has expert staff to facilitate concept c...

Innovation in medical technology (MedTech) has always been driven by curiosity, creativity and the pursuit of better patient outcomes. Today, however, the pace of change is accelerating, and technology is no longer simply supporting innovation in MedTech – it is helping power it. As populations age and chronic diseases become more prevalent, the demands on those working in healthcare will intensify. Clinicians and patients alike are seeking innovative solutions that offer increased levels of precision, faster recovery times and more personalised care. Meeting these expectations requires more than leadership and talent alone; it demands new ways of thinking and new tools to drive progress. Technology has emerged as one of the most powerful catalysts of change. Advances in engineering and manufacturing are fuelling a new wave of innovation and new ways of designing and delivering medical solutions. By enabling smarter healthcare solutions, we can assist clinicians worldwide to deliver better outcomes for patients and ultimately improve lives. Digital technology transforming care Up until recent years, MedTech innovation has relied on incremental improvements, such as the enhanced surgical instruments and more precise implants. While these remain critical, companies across the sector, including Stryker, are leveraging technology to reshape what is possible. Across the industry, we are seeing firsthand how engineering is transforming not just medical devices, but patient care, hospital workflows and the future of health itself. Robotics, for example, is no longer a futuristic concept. They are integral to operating rooms worldwide, enabling minimally invasive procedures and providing surgeons with precision and control. Likewise, AI is changing how clinicians approach patient care by improving the speed and accuracy of diagnostics. The engineering behind these systems is incredibly complex, yet it is designed with one goal in mind – to improve patients' lives. Innovation is not without its challenges. Engineering cutting-edge solutions demands rigorous testing and close collaboration across industry and practice. As a leader in MedTech innovation in Ireland for over 27 years, Stryker views these challenges as opportunities to push boundaries in a thoughtful and considered way. A new era of MedTech manufacturing Advanced manufacturing is redefining how MedTech companies design, build and deliver solutions to clinicians and patients. Technologies such as additive manufacturing and 3D printing are enabling levels of precision, consistency and customisation that were once not possible. These technologies allow for faster development cycles, enabling us to move from concept to production in days or weeks rather than months. They also support more personalised solutions, such as patient-specific implants and surgical instruments. Ultimately, advanced manufacturing is more than a production method; it is a medium for increased innovation, helping us to respond to clinical challenges faster and improve solutions that support better patient care. Stryker has been a pioneer in the field of advanced manufacturing, and we are particularly proud of the progress we have made in the field of 3D printing. Stryker's AMagine Institute at our Anngrove site in County Cork is home to one of the world's largest and most advanced 3D printing facilities and a key hub in a global network. Equally important is inspiring the next generation of MedTech innovators. That's why we're proud to collaborate with I-Form, Research Ireland's Centre for Advanced Manufacturing, on the 'Manufacturing a Healthy Future' programme, which introduces students to 3D printing at an early stage and has seen more than 2,000 students participate since its launch in 2021. Accelerating innovation One of the most important and exciting technological advancements in recent years is digital twins. More than a simple simulation, digital twins create precise virtual replicas of patie...

You've got solid clinical evidence. People say they love your product. But adoption still isn't happening. Why?In this episode, Hakeem breaks down key insights from his conversation with Julian Moore on why so many clinically sound MedTech products struggle to gain traction in real-world settings. If you're a clinician-founder trying to cross the gap between “good product” and “actual uptake,” this episode is your blueprint.Discover why adoption is a system wide behaviour change, not just an individual “yes”Learn how to identify hidden blockers - including overlooked people in the workflowGet tactical: match your strategy to the real barrier, not the one you assumedHelping clinicians simplify their go-to-market strategy, so they can stop guessing, and turn their working prototypes into international MedTech businesses.Hit play now to find out how to move from barriers to behaviour change and finally see your evidence turn into adoption.Message me via DM on LinkedinTake the simple adoption risk quizThis podcast is for clinicians turning medical devices into real businesses, with practical insight on go to market strategy, exporting, and scaling in international MedTech.

In this episode, Duane Mancini sits down with Stan Glezer, Managing Director at Outcome Capital, to dive deep into the roles of strategic advisory and investment banking in driving innovation within the life sciences sector. Stan elaborates on his multifaceted career, from his beginnings as a physician to leading roles in biopharma and MedTech companies. He discusses the importance of aligning a company's value proposition with market dynamics, the art and science behind M&A deals, and why realistic, transparent goals can unlock transactional success. Stan Glezer LinkedInOutcome Capital WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law and JumpStart Inc.

In this episode, Etienne Nichols sits down with Thor Rollins, a leader at Nelson Labs and the convener of the committee revising ISO 10993-1. The conversation centers on the newest 2025 version of the standard, which represents a massive philosophical shift from a "checkbox" testing mentality to a rigorous, risk-based approach aligned with ISO 14971.Rollins explains that modern medical devices are far more complex than the metal and hard plastics of the past. With the rise of degradable materials, coatings, and nanomaterials, traditional animal testing often fails to provide the best science. The new standard introduces critical concepts such as biological risk estimation, foreseeable misuse, and a comprehensive lifecycle evaluation that looks beyond "time zero" safety.The duo also discusses the practical implications for manufacturers, including the controversial requirement to evaluate biocompatibility at the end of a product's lifecycle—a particular challenge for reprocessed devices. Rollins provides insider knowledge on the US's stance on the revision, the timeline for FDA recognition, and how companies can leverage biological equivalence to potentially reduce their testing burden.Key Timestamps01:45 – The shift from "checkboxing" to a risk-based approach.03:10 – The rapid timeline of the 2025 revision and the influence of ISO 14971.04:22 – Lifecycle Evaluation: Assessing safety beyond the "brand new" state.06:50 – Chronic toxicity vs. acute reactions: Why front-end evaluation matters.08:15 – Foreseeable Misuse: When doctors use scopes outside their intended anatomy.12:10 – The concept of Bioequivalence: Using existing data to justify reduced testing.13:45 – Breakthrough: The removal of material-mediated pyrogenicity testing for known materials.15:30 – Why the US voted "No" on the current draft: A call for better guidance.18:50 – Notified Bodies and MDR: The 2025 version as "State of the Art."21:15 – Practical chemistry tests for aging polymers (DSC, GPC, FTIR).25:40 – Advice for small vs. large companies on building material databases.Quotes"The testing that we developed back in the 50s and 60s actually doesn't really work the best with some of these complex devices... we've been moving the standard away from what we call checkboxing." - Thor Rollins"I only say that expensive tests always impact innovation. We don't want to over-test, but we want to do the right tests." - Thor RollinsTakeawaysLifecycle is the New Frontier: You must now evaluate biocompatibility throughout the product's life, especially for reprocessed devices that

In this episode, we sit down with Becca Meehan, a certified coach and advocate for gender equality in the MedTech industry. Becca shares her journey from corporate marketing and sales to founding her coaching practice focused on empowering women in medtech. Together, they explore authentic leadership, self-care, navigating career transitions, and why investing in yourself isn't selfish- it's essential. EPISODE CHAPTERS 00:00 – Welcome & Introduction 03:17 – "Go-Get-Hers" Origin Story 06:38 – The Importance of Sales Experience in Marketing 08:31 – Defining Moments in Leadership 09:55 – Early Career Lessons in Communication and Mindset 15:53 – Building Resilience Through Challenges 18:26 – The Ripple Effect of Caring Leadership 21:21 – Self-Care: The Key to Caring for Others 22:24 – Navigating Redundancy: It's Not Personal 28:39 – Embracing Change: The Path to Coaching 32:45 – The Transition to Coaching: A New Chapter 36:03 – Empowering Women in MedTech 39:55 – Women in MedTech Navigating Noise in the Modern Workplace 41:46 – Past Mentor's Advice: The Importance of Running to the Fire 44:10 – Uncovering Personal Narratives and Mindset - Face vs Fiction 47:58 – The Power of Reflection and Self-Discovery 50:16 – Investing in Personal Growth and Community 53:56 – Morning Rituals and Getting Your Ducks in a Row 55:31 – Mentoring with Care and Presence 59:45 – CTA - Becca's Offer SPECIAL OFFER FOR MEDTECH MENTOR LISTENERS This February, Becca is offering: 30-minute complimentary connect call for all Medtech Mentor listeners 25% off all coaching packages for the month of February '26 CONNECT WITH BECCA Website LinkedIn: Becca Meehan

This episode explores the transition from the Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR) and the foundational elements required for medical device compliance. Host Etienne Nichols and guest Mike Drues discuss the philosophy of building a usable system rather than a "museum of SOPs," emphasizing that the standard list of QMS sections should be viewed as a starting point rather than an exhaustive checklist.The conversation examines the critical differences between 510(k), De Novo, and PMA pathways regarding manufacturing requirements. While a 510(k) submission may not strictly require detailed manufacturing information at the time of filing, Mike explains why companies must remain audit-ready from the moment they register their establishment with the FDA. The discussion clarifies the timing of registration and the "radar" companies enter once they become commercially active.Finally, the dialogue focuses on a "triage" approach for resource-constrained startups. By prioritizing Design Controls and Risk Management during early development, teams can remain compliant and ethical without over-investing in post-market systems, such as complaint handling, before they have a product on the market. Mike warns against the dangers of "copy-and-paste" quality systems, urging manufacturers to use professional judgment to tailor their processes to their specific technology.Key Timestamps00:00 - Introduction to QMS requirements and guest Mike Drues.03:45 - The core sections of a QMS according to the Quality System Regulation.05:12 - Why the QSR list is a starting point, not a stopping point.08:20 - Regulatory vs. Ethical vs. Economical: The three legs of the medical device stool.10:30 - Do you need a full QMS for 510(k) vs. PMA submissions?13:15 - Understanding the timing and strategy for FDA Establishment Registration.15:40 - The Triage Approach: Which QMS sections matter most during early development?19:00 - The dangers of boilerplate SOPs and non-specific quality manuals.Quotes"This is a starting point. This is not a stopping point... Use your own good judgment." — Mike Drues"The goal is not really to build a museum of SOPs; the goal is a quality management system that teams will actually use." — Etienne NicholsTakeawaysPrioritize the Big Four: During the development phase, focus your limited resources on Design Controls, Risk Management, Document Control, and Supplier Quality Management.Understand Pathway Nuances: While 510(k) submissions don't require manufacturing details, you must be fully compliant and ready for inspection once your establishment is registered and the product is launched.Avoid Boilerplate SOPs: Quality systems must be specific to your organization. Including irrelevant device types or procedures in...

Insightec est une entreprise de pointe dans le domaine des Medtech, spécialisée dans les équipements médicaux pour la neurochirurgie fonctionnelle.Hébergé par Audiomeans. Visitez audiomeans.fr/politique-de-confidentialite pour plus d'informations.

#procurement #logistics #supplychain #medicaldevice #biotech #hightech #ai #resilience Welcome to the latest episode of Supply Chain Pioneers with Kevin Nelson, Senior Operating partner and advisory board member at Bio Stream Medical Consulting. Kevin shares his 35 years of experience in procurement and supply chain, spanning high tech, biotechnology, and medical technology sectors. He discusses his accidental journey into procurement, his progression from operational roles to consulting at IBM, and his strategic insights in the med tech space. Kevin also highlights the transformative role of AI in procurement and supply chain, the importance of stakeholder relationships, and the evolving nature of leadership. Tune in to learn how embracing technology and fostering meaningful relationships can elevate the supply chain industry.   00:00 Introduction to Supply Chain Pioneers Podcast 00:35 Meet Kevin Nelson: Career Overview 01:58 Falling into Procurement 03:31 Transition to Consulting 05:50 Finding Purpose in Life Sciences 07:23 Strategic Purchasing Insights 09:58 Leadership and Team Building 14:22 Embracing AI in Procurement 17:47 Future of Supply Chain Roles 20:53 Personal Insights and Conclusion

(02:20) Pills that communicate from the stomach could improve medication adherence(07:13) Innovative Solutions for Tracking Medication(10:46) The Technology Behind the Smart Pill(13:42) Conclusion and Future Implications This episode was brought to you by Mouser, our go-to source for electronics parts for any hobby or prototype. Click HERE to learn more about making healthcare smarter with electronics. Become a founding reader of our newsletter: http://read.thenextbyte.com/ As always, you can find these and other interesting & impactful engineering articles on Wevolver.com.

In this episode of Medsider Radio, we sat down with Marina Pavlovic Rivas, co-founder & CEO of Eli Health.The company is focused on making hormone data accessible in real time through its saliva-based testing system that delivers results through a mobile app. A data scientist by training, Marina previously founded Gradiant AI, a machine learning company that was acquired in 2019. In this interview, Marina discusses how to evaluate form factor options without locking into a design too early, what beta testing reveals that years of lab work can't, and how existing consumer spending patterns influence positioning and pricing strategies. She also shares how regulatory considerations shaped product decisions from the outset and why building in-house proved more efficient than outsourcing when external partners said the company's goals were impossible.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.And if you're ready to level up your medtech game, you should check out Medsider Courses — 8-week masterclasses covering topics like fundraising, M&A and exit planning, design and development, clinical and regulatory strategy, and commercialization.These courses, featuring hard-earned lessons from elite medtech CEOs, can be purchased individually or come free with our All-Access Pass.If you'd rather read than listen, here's a link to the full interview with Marina Pavlovic Rivas.

In this episode, Duane Mancini sits down with Katie Brinkman to discuss the nuances of biocompatibility, the critical role of biological evaluation plans, and the evolving regulatory landscape, including the importance of risk assessment. Katie also shares her experience with biocompatibility evaluation during significant regulatory changes such as EU MDR remediation and the 10993 standard updates.Katie Brinkman LinkedInHohenstein WebsiteHohenstein Group LinkedInDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law and JumpStart Inc.

In this episode, host Etienne Nichols sits down with Ashkon Rasooli, founder of Ingenious Solutions and a specialist in Software as a Medical Device (SaMD). The conversation previews their upcoming session at MD&M West, focusing on the critical intersection of generative AI (GenAI) and quality assurance. While many AI applications exist in MedTech, GenAI presents unique challenges because it creates new data—text, code, or images—rather than simply classifying existing information.Ashkon breaks down the specific failure modes unique to generative models, most notably "hallucinations." He explains how these outputs can appear legitimate while being factually incorrect, and explores the cascading levels of risk this poses. The discussion moves from simple credibility issues to severe safety concerns when AI-generated data is used in critical clinical decision-making without proper guardrails.The episode concludes with a forward-looking perspective on how validation is shifting. Ashkon argues that because GenAI behavior is statistical rather than deterministic, traditional pre-market validation is no longer sufficient. Instead, a robust quality framework must include continuous post-market surveillance and real-time independent monitoring to ensure device safety and effectiveness over time.Key Timestamps01:45 - Introduction to MD&M West and the "AI Guy for SaMD," Ashkon Rasooli.04:12 - Defining Generative AI: How it differs from traditional machine learning and image recognition.06:30 - Hallucinations: Exploring failure modes where AI creates plausible but false data.08:50 - The Autonomy Scale: Applying standard 34971 to determine the level of human supervision required.12:15 - Regulatory Gaps: Why no generative AI medical devices have been cleared by the FDA yet.15:40 - Safety by Design: Using "independent verification agents" to monitor AI outputs in real-time.19:00 - The Shift to Post-Market Validation: Why 90% validation at launch requires 10% continuous monitoring.22:15 - Comparing AI to Laboratory Developed Tests (LDTs) and the role of the expert user.Quotes"Hallucinations are just a very familiar form of failure modes... where the product creates sample data that doesn't actually align with reality." - Ashkon Rasooli"Your validation plan isn't just going to be a number of activities you do that gate release to market; it is actually going to be those plus a number of activities you do after market release." - Ashkon RasooliTakeawaysRight-Size Autonomy: Match the AI's level of independence to the risk of the application. High-risk diagnostic tools should have lower autonomy (Level 1-2), while administrative tools can operate more freely.Implement Redundancy: Use a "two is one" approach by employing an independent AI verification agent to check the primary model's output against safety guidelines before it reaches the user.

Are you wondering why your clinically sound medical device still isn't being adopted—even after pilots, approvals, and glowing data?If you're a clinician founder ready to take your MedTech prototype to market, this episode breaks down the overlooked reason most devices fail to gain traction. It's not the product—it's your go-to-market execution. Learn how behavior change, system fit, and implementation science play a bigger role than your evidence ever will.Discover the #1 mistake clinical founders make after running pilotsLearn how to identify all the “whos” involved in adoption—and why missing one can ruin your rolloutUnderstand how to turn barriers into behavior-changing strategies that scale across bordersPress play to learn the proven system for moving your MedTech device from “great pilot” to international success—without wasting cash or time.Message me via DM on LinkedinBook a 30 min discovery call for the Healthcare Export Accelerator ProgrammeThis podcast is for clinicians turning medical devices into real businesses, with practical insight on go to market strategy, exporting, and scaling in international MedTech.

Howard “Hojo” Johnson is one of the most accomplished commercial leaders in medical device sales, known for being the first hire trusted to build markets from zero and scale teams into category leaders. In this episode of the Chase MedSearch Podcast, Howard shares how he helped launch and grow organizations at Nevro and Axonics—turning early-stage companies into national forces in neuromodulation.We dive into what it takes to build high-performance MedTech sales teams, how to lead people through rapid growth, and why servant leadership and belief drive sustainable results. Howard breaks down his approach to hiring elite talent, developing future leaders, executing go-to-market strategies, and avoiding the common mistakes new managers make.This conversation is essential listening for medical device sales reps, managers, and executives who want to scale markets, build winning cultures, and grow long-term careers in MedTech.RESOURCES:

Shaun Bagai is the CEO and Director of RenovoRx, and a seasoned MedTech leader whose path began with a Silicon Valley startup internship that ultimately pulled him away from medical school and into building life-changing technologies. Shaun shares how early experiences in clinical research, physician training, and commercialization—from Medtronic to multiple high-growth startups—shaped his leadership philosophy around mentorship, hiring for “fit,” and balancing empowerment with accountability. Shaun reflects on legacy, values-driven leadership, and why networking rooted in genuine curiosity can become one of the most powerful tools in a MedTech career. Guest links: https://renovorx.com/contact-us/ | https://www.linkedin.com/in/shaun-r-bagai/   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 072 - Shaun Bagai [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I am delighted to introduce you to my guest, Sean Bagai. Sean has served as Chief Executive Officer and Director since 2014 of RenovoRx. Prior to joining, he led global market development for HeartFlow, Inc from 2011 to 2014, which included directing Japanese market research, regulatory payer collaboration, and key opinion leader development to create value, resulting in a company investment to form HeartFlow Japan. During his tenure at HeartFlow, he successfully orchestrated their largest clinical trial to date and contracted HeartFlow's first global customers. In addition, Sean has launched innovative technologies into regional and global marketplaces in both large corporations and growth phase novel technology companies. Sean is a graduate from the University of California Santa Barbara with a Bachelor of Science in Biology / Pre-med. All right. Well, thank you so much for being here, Sean. I'm so delighted to speak with you today. [00:01:54] Shaun Bagai: Thanks for the opportunity. I really appreciate it. [00:01:55] Lindsey Dinneen: Of course. Well, I'd love, if you wouldn't mind starting off by just telling us a little bit about who you are, what your background has been like, and what led you to MedTech? [00:02:07] Shaun Bagai: I really appreciate the question 'cause it's really my background and kinda the early part of my journey that landed me where I am today. I actually did an internship at a medical device startup company in Silicon Valley between what would've been college and med school. And while I was applying to med school, my goal was to get some experience in the industry, in a medical technology space, and then go out to med school. And the founder of my company and CEO really advised me not to go to med school once I got in to become, someday an entrepreneur like his own self. And I ended up following his footsteps with the goal of, just like he, did build companies that really make a major impact on medicine. [00:02:44] Lindsey Dinneen: Wow. [00:02:45] Shaun Bagai: So from, yeah, so from that early kind of intro to medical technology and learning what an entrepreneur could do in building new therapies and technologies, I ended up running clinical research at that company once I declined med school. We exited to Medtronic where I learned the sales side of things. So, this physician founder CEO along with my mentor, said, look, if you want to build and run companies, you have to really understand what the market's like and how you get a product into the hands of physicians to treat patients and what it takes to really sell the product. So I spent a couple years flying around the country training physicians on the technology that I learned as a proctor-- which I've done in every company that I've worked with and for-- then went on to sales for about five years and launched Medtronic's first drug coated coronary stent as a sales representative. And then transitioned out of Medtronic after several years, cutting my teeth on the big company dynamics and the sales revenue aspect of it to a startup company called Ardian, which developed a new way to treat high blood pressure using a device. There I led physician training, transitioned them from clinical research into commercial in Europe. We exited to Medtronic for about a billion dollars and went on to another startup company to help develop their market. And really that was a disruptive technology in how to assess coronary artery disease in leading international market development. They hired me about 15 years prematurely to commercialize them, so I helped them with physician training, market development in Japan, clinical research and left to join RenovoRx where I took over 11 and a half years ago. That company actually went public for about 2.5 billion this last year. So, and all three of these technologies have really already made a major impact on patients, and I feel that RenovoRx, this has probably my biggest one yet in terms of major impact. [00:04:26] Lindsey Dinneen: Yeah. Okay. So I can't wait to dive into that, but there's a lot before that too to talk about. So, when you were growing up, was medicine and science always a huge interest to you or did that develop later on? [00:04:41] Shaun Bagai: You know, it's funny you asked 'cause I've done a lot of interviews and that question has never come up. So I've gotta, I've gotta pause for a second. It's interesting. My, my background was really business oriented growing up. I loved business. I loved the idea of how you get something marketable. As a very young child, I had very embarrassing stories of trying to sell things as a kid that I used to bring back from India, for example, like bouncy balls or crocheted place mats or whatnot. But then sustaining a football injury in high school, I found that physicians couldn't treat me. And I learned that there's gotta be a different way to treat patients. And I arrogantly thought, "Well, I could be a better doctor than you guys and someday treat young athletes like myself." So, my passion went immediately and complete a hundred percent into become a physician to help patients. So that kind of transitioned me to being med school bound from the age of about 15, and didn't look back until I got into med school and got pushed back to business. And now I get the best of both worlds. [00:05:37] Lindsey Dinneen: Yeah, no, absolutely. So you have so many diverse experiences with a bunch of different companies and you know, everything from it sounds like a quite the small team to obviously these huge enterprise type companies. What are some of the key lessons you learned along the way that help you in your current role? [00:05:58] Shaun Bagai: I think the biggest aspect I've learned along the way, and what I'd definitely tell the younger entrepreneurs, is to be very open and receptive to different ideas. Also look for mentorship and leadership examples. And I've been lucky throughout my career, I've been able to identify leaders who are not perfect because no one is, but I found skill sets and activities and thought processes that I wanted to emulate, and I feel like I've been successful because I've been able to take the best of those and also look for mistakes and weaknesses and to see how I could either surround myself with people to fulfill my lack of strengths in areas and or improve on myself to help be a better leader by emulating them. [00:06:37] Lindsey Dinneen: Yeah. And speaking of leadership, as you kind of grew into all of these, you know, more and more responsibility laden roles, were there any moments along the way where you kind of just had these learning curves of, you know, either witnessing something that you were like, "Oof, I don't wanna do that." Or the opposite of it sounds like you had maybe some really great mentors in your life that showed you perhaps a better way of doing things. But in terms of your overall leadership strategy, how did the various good, bad, and ugly shape how you show up as a leader? [00:07:16] Shaun Bagai: You know, that's a four hour discussion probably, but, but to, to tackle some of the high notes that I learned, it's --and I continue to always learn-- the biggest challenge we face as leaders is trying to find out what makes people work in the right fit for your organization. And as, as you mentioned aptly, I've worked for very large and small teams, big companies, small companies, and not everyone's fit for those positions. You have very talented, enthusiastic, passionate people that could really flourish in a big company structured environment and would die in a startup company. And vice versa. You have very structured people that cannot understand the idea of progress ahead of process in small companies as well, and finding that balance of trying to get the best out of what someone likes to do and what their fit is. And further really identifying if you can align their passions and their career goals, what the company's goal is, you find the dynamite employee. So I try to find that balance has been difficult and challenging. My biggest challenge I think, in learning curve for me was trying to have both the non micromanaging skillset and then also the oversight and ability to let people run and to be successful and grow and learn and make mistakes. And then teach them from the mistakes, they'll become stronger leaders under you as well. [00:08:32] Lindsey Dinneen: Yeah. Yeah, absolutely. All right, well, bringing us to the present day, what does your company do? What are the innovative solutions that you're providing? Because I know you are on the cutting edge of a lot of really amazing technology. [00:08:48] Shaun Bagai: Yeah, it's been very exciting. We are finding a different way to treat cancer patients, and if you think about therapeutics in general, we as a medical industry and society have really looked at, "Okay, how do we kill a tumor? How do we prolong life?" And a lot of times we forget that there's a patient that's harboring that tumor and maybe the life isn't really worth it when you beat them up with chemotherapy every day and they're on a couch, not eating, not spending time with family. And what we've developed invented and really built out now commercial with a clinical research program as well, is how to localize therapies such that you don't have the systemic toxicities, but you do have the effect for patients live longer. And tumors that really don't behave well when it comes to cancer therapy, like pancreatic cancer is where we spent the bulk of our time so far. [00:09:31] Lindsey Dinneen: Okay. And then can you talk a little bit more about what makes your approach so innovative? [00:09:39] Shaun Bagai: It's really by accident like most great medical are. It's a physician who had an idea based off a single patient where he saw a challenge. And Dr. Ramtin Agah, the founder of the company, had a pancreatic cancer patient, and as a cardiologist his cardiac patient had pancreatic cancer and had a bleeder. And he scrubbed in with a radiologist to treat the bleeder and found that there's no good device to isolate segments around the pancreas because of the way the anatomy is. So what differentiates us is it was after an unmet need first, and then came the device technology and then clinical data, and now adoption where tumors like pancreatic cancer tumors don't have high blood flows posing them not susceptible to chemotherapy and not a good target for local delivery. So he developed and invented this therapy and technology to really get high doses of chemotherapy in these types of tumors in a manner and mechanism that's very different than we've ever seen before. And that's looks like it's being successful. [00:10:34] Lindsey Dinneen: Wow, that's amazing. So you have had some clinical validations, clinical trials as well? Yeah? [00:10:41] Shaun Bagai: Yeah, we did. Yeah, for sure. We did a phase one two trial initially in pancreatic cancer, non-metastatic. We found that patients that are expected to live between 12 and 20 months, let's say, or even narrower these days, about 14, 15, 16 months-- our patients were living over two and a half years and we were starting to push survival where many patients were 3, 4, 5 years since diagnosis. Since then, we've launched a phase three trial based on that, and that's wrapping up enrollment soon. And based on the success of the therapy and technology in terms of toxicities, a lot of physicians have said, look, we want to treat patients today with this. And given that the device is FDA cleared, we've now begun to commercialize the device component for physicians to use at their discretion, where we're starting to see benefit for patients across the spectrum. [00:11:25] Lindsey Dinneen: Wow, so, so this is a very highly targeted-- it's able to get right to the source, right, so that there, it kind of helps to-- like you mentioned, there are some cancers that are much harder to treat by just sort of your, well, more standard practices with chemotherapy. So can you explain a little bit more about how it works in terms of the delivery? [00:11:50] Shaun Bagai: Yeah, think about tumors like pancreatic cancer tumors as cities with freeways next to them with no off-ramps. And that's one of the biggest issues is that when we think about tumors in general, we think of a ball of blood vessels with a lot of tumor cells. So blood supply gets there, they feed the tumors, but it also creates a, you know, off ramps or a highway to the tumors where chemotherapy reaches. Other tumors like pancreatic tumors, glioblastoma or brain tumors, non-small cell lung cancer bile duct cancer, uterine tumors, many others, they don't have this large blood supply. So it's like there's a freeway going next to a tumor and the chemotherapy doesn't see that tumor. So the way we've developed our technology, it's a double balloon catheter based system, so it's minimally invasive. It goes in through the patient's leg artery. And the patients are-- it's not a full surgery. It's more of a minimally invasive, same day outpatient procedure where the device isolates blood flow next the tumor, and uses pressure to force the chemotherapy to leave the vascular system to then bathe and saturate the tumor with chemo. So again, if you think about that freeway without an off ramp, we basically are forcing and creating and finding these micro channels like an off ramp to actually access the tumor. And this is where all our patents lie as well. So we developed this whole new method and mechanism of delivery of drugs and chemotherapy. [00:13:07] Lindsey Dinneen: That is amazing. So I'm sure that there are probably many stories as you've done this and just throughout your whole career. But are there any moments that really stand out to you as kind of affirming for you that, "Wow, I am in the right industry at the right time." [00:13:26] Shaun Bagai: I, I've luckily been validated with that thought process my whole career. As as a son of Indian parents, many say, "How did you not go to med school once you got in? Were you a disappointment to your family? Do you regret not gonna medical school and becoming a physician?" And I've been very lucky that I spent my whole career successfully helping technologies treat patients. The first moment was my first job going from declining med school through running clinical research and being the lead physician proctor, I used to fly around the country and teach doctors how to open up leg arteries that otherwise would be amputated. And by with this new technology, it was great to see how great patients were doing because of our technology. And every company I've worked on since has had that same effect on patients. So luckily, it's been always along the way, and very luckily, it was very early in my career to validate this this was the right pathway. [00:14:13] Lindsey Dinneen: Yeah. You know what you've mentioned too at the beginning that it sounds like a huge passion of yours, and maybe it has always been the case, but is making a difference in people's lives, being a part of companies that are, you know, actively improving and helping save lives. And so, I'm curious too, where did that passion come from? Was that part of that sort of, "I'm gonna be a physician, I'm gonna, you know, I'm gonna do this whole thing, I'm gonna save the athletes," but then, you know, kind of evolved from there? Or is that more deep seated? [00:14:46] Shaun Bagai: You know, it's interesting, I think it evolved along the way. I've always tried to be a helpful person in general, just as a human being. The, again, the, I think the initial idea was I wanna help patients because they couldn't help me as an athlete. So orthopedic surgery or cardiology were kind of the two i ideas or areas I wanted to specialize in when I thought the med school route. And then it was a matter of, I love the science, I love the technology, I love the medical science as well, and I love the business aspect of it. So I learned that there's this whole industry called medical technology that allows you to do all of that. And after seeing the benefit to our patients as a young clinical researcher, I really got the the addiction to trying to find ways to treat patients better. [00:15:29] Lindsey Dinneen: Yeah. Well, and I think I'd be curious to know too, 'cause I think, you know, that passion also comes from probably some core values that you hold that have sort of guided you. And I would wonder too is with, as having had such a diverse amount of really cool industry experience, what are some things that have been the guiding lights as you've gone around, you know, just things that you come back to as core values for how you wanna show up in the world? [00:15:59] Shaun Bagai: It's a very interesting question. I think one of the most interesting books that I have opportunity to be exposed to is "True North" and it's basically CEO's paths on aligning values with the company values and goals and making sure that that what you're doing is the right way to do things and the right thing to do. Often people can misstep as leaders in taking shortcuts and how you treat people. And there are no shortcuts. It's the hard work, it's the lead by example. It's putting in the late hours and demonstrating this is how you get things done. So I think that's probably a biggest part of making sure you align well with the company goals and having those values in place. And also how you treat people. We have a lot of leaders who are not the nicest people to their employees. I'm not gonna name any current companies, but, we all hear stories, they all exist. And I find that back to the, one of the original ideas is that when you align yourself and when you actually care about the people you work with and like the people you work with, they work harder and you work better as a team. And at the end of the day, all of us who work hard spend more time working than with our families and loved ones. And you want to actually make that fun and challenging and interesting and successful and it's almost like a second family, the people you work with. And it's important to keep that in mind 'cause people lose that a little bit. [00:17:12] Lindsey Dinneen: Yeah. Well, and I wanna go back to something you said too because this is actually a timely, interesting topic because of something that recently happened that I heard, and, you know, basically it was this idea of, if the personal goals aren't aligned with the company goals, they're not really worthwhile. And I was really struck by that comment and I was surprised by it because I don't feel that is true. Basically, to your point, part of it is you are spending, you're a hard worker, right? And so you're motivated to come in, you know you're doing things that matter. So it makes sense that you're going to have sort of, what would we call it, sort of innate personal goals that would hopefully align with the company's goals? But I'm curious, as a leader yourself, when you're helping your team maybe even develop or nurture those kinds of personal goals, how do you help them succeed both, you know, personally and professionally themselves, but then for the company so that as a whole, we are successful? [00:18:13] Shaun Bagai: I, I believe honestly, that's easier to do in a smaller startup type company than the large organizations. And the reason is because people who choose these types of companies have really strived to learn and grow, be exposed to, they're passionate about what they're doing 'cause it is so hard to be successful and there's always risk. And so I feel like building, running, working with and for companies that are kind of in a growth smaller phase, it almost weeds out the wrong types of people in terms of their ability to be passionate and work hard enough for that common goal. Because pretty quickly, and I've heard this before, and we've gone through this with our own companies, "This is too much work." And I've got someone else who was working 90 hours a week because they were so passionate about what we're doing with patients and they were touched by cancer. We've had cancer patients in the company, we've had family members with the cancer, so I feel like by nature you almost weed out the people that aren't the right fits. And there's also personal goals, and you know, people always have selfish motives at the core in certain areas, but being in a small company, you can identify where someone like to grow. And being in a small company, everyone does everything. In large siloed companies, you kind of miss that. And some people like that. They like the control, they like the punch and punch out, which is great. But when you're trying to build a small organization that's growing and pivoting and shifting, people like that fast-paced environment, and that's how I got lucky in how I grew. I got to do everything as a young, you know, post undergrad where I did clinical research and clinic, preclinical research and marketing and a little bit of sales and physician training, and that really allowed me to spread my wings and everyone I've mentored and guided and worked with feels the same way. [00:19:48] Lindsey Dinneen: Yeah. Yeah. I love that perspective. I think you touched on something that's really key is the alignment of goals in the sense of, we all know we're striving towards the same things, like we all want our patients to be healthier and live longer, better lives, you know, or what, whatever the mission statement is, per se, but being aligned and having that shared passion makes such a difference. So, okay, 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, but it doesn't have to be. What would you choose to teach? [00:20:28] Shaun Bagai: You know, it's I used to think about that question when I was younger and thought "I have no talents." [00:20:31] Lindsey Dinneen: Oh, no. [00:20:33] Shaun Bagai: Yeah. But I've learned over the years that the things that make me successful are the ones that you don't think about. At least I didn't think about forefront. I think networking is probably the biggest piece, is really thinking about people who can have a positive impact and influence, and keeping in touch and not judging people, not dismissing people, not holding grudges. And you find along the years that you end up collecting a lot of interesting people that could be helpful for you down the road or you could help connect them. So I like connecting other people who can help people. And it's amazing. Throughout my career, I come back and I remember a fellow in Germany, I worked with my first company and he was in town for a conference. Fast forward 15 years, I'm like, "Hey, Dr. Naber, I'm in town. Why don't we meet? What are you up to these days?" "Oh, I'm working with this company called HeartFlow, and we have a new medical technology on looking at coronary artery disease. What are you up to?" "Oh, I'm the head of the hospital system in Frankfurt." It's like, wow, a lot's changed in 15 years and all of a sudden he became one of our biggest investigators and it's, and it wasn't because I thought I'd get something out of him. It's just I like keeping in touch with people and who knows where your path cross, and I've been able to connect other people to other people in the same regard. So, I remember I gave a talk about nine years ago on, on how I got to become a CEO of this company and I had this kind of Brady Bunch PowerPoint presentation. "Well, this person got me a job as an intern at this company. I met this doctor here. I met this company there," and there was like this spider web of how I got here. And it's amazing how all these people had an impact on my life at some point or another. And a lot of my team members are the same thing. It's amazing how many people you end up knowing if you're friendly, nice nonjudgmental, don't hold grudges, and people learn, grow, mature, change careers, and it's good to really treat everyone well and it comes back. [00:22:12] Lindsey Dinneen: Yeah. Could not agree more, and oh my goodness, I was just thinking about, yeah the, also the fact that, you know, as, as large as the industry is, it actually is also very small, so people know each other and so you also need to be cognizant of that as you're interacting. But I'm curious, just real follow real quick follow up to your point, what would be your advice for somebody who feels a little bit, maybe awkward or they're introverted, so it's a little bit harder to start those conversations. What would be a piece of advice for somebody who might either be new to networking or just not be comfortable with it very much? [00:22:52] Shaun Bagai: It is interesting 'cause I've been an extrovert mostly, but I'm also shy, which is oxymoronic. And I've got team members who have no problem walking up to, let's say a famous CEO or person and saying, "Hey, I'm i've got a question for you." And I think it's a matter of trying to break outta your comfort zone and ask questions because I find that most leaders do like to give back and do like to mentor. And a lot of them are very intelligent and a lot of 'em think a lot of themselves. And people like to talk and to teach. So, and that's more often the case than not. So for someone a little bit shy or trying to break into that idea is finding the right mentors and asking questions. People like to talk usually. And using that and being confident there, and also understanding that you may get blown off. You may get a no, you may get, you know, and not being disgruntled and going after it again and again, even though it's, it's difficult sometimes, but just to push yourself forward and be out there. [00:23:47] Lindsey Dinneen: Curiosity and persistence. I like it. There you go. There we go. All right. And how do you wish to be remembered after you leave this world? [00:23:59] Shaun Bagai: You know, I think about one of my first mentors, Dr. Josh McElroy. He has made an impact on medicine-- yeah, get emotional when I think about it-- that's mentored so many young people and built so many technologies that helps patients, and leaving this world having an impact on medicine where I help build therapies and technologies that made an impact for generation lives to come is really important. [00:24:23] Lindsey Dinneen: Yeah. And that's a beautiful legacy. Yeah. All right. And then final question. What is one thing that makes you smile every time you see or think about it? [00:24:33] Shaun Bagai: You know, I think it's the comradery with my team at work. And it's interesting 'cause the best days I work, it doesn't matter what's happening. If we're aligned and we have the same mission and we are pushing for the same direction. When you have 10 people wrong go about in the same direction, it feels amazing. And that's something that I really enjoy. And of course, it's not gonna be like that every day, every minute. And the challenges are always big and there's always, especially with an intelligent senior staff, there's always disagreements and arguments. But being open-minded and aligning and they, we always come around and align, those are the things that really make me smile. [00:25:08] Lindsey Dinneen: Yeah. That's great. That's awesome. Well, this has been a fantastic conversation. I really appreciate your time and your insights. I really appreciate, especially you going a little bit deeper into, yeah, kind of, kind of the lessons learned and what makes you tick and your passion for this industry and your current role. And we're so honored to be making a donation on your behalf as a thank you for your time today to the American Society for the Prevention of Cruelty to Animals, which is dedicated to preventing animal cruelty in the United States. So thank you for choosing that organization to support and we just wish you continued success as you work to change lives for a better world. Shaun Bagai: Thanks for the opportunity, Lindsey. Lindsey Dinneen: Thank you also to our listeners for tuning in, and if your feeling is 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. [00:26:01] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world.

Design History File (DHF) remediation is rarely planned — yet it is a recurring challenge for many medical device manufacturers, especially during audits, inspections, acquisitions, or regulatory framework changes.In this podcast episode, we provide a structured and practical discussion on:The definition and purpose of a DHFKey differences between FDA QMSR and ISO 13485 requirementsHow the DHF concept is addressed within ISO 13485When DHF remediation becomes unavoidableTypical causes of remediation, including accumulated DHF debtHow to remediate a DHF without creating new compliance risksCommon pitfalls and practices to avoidHow to define a realistic and defensible remediation strategyRegulatory communication considerations with:National Competent AuthoritiesNotified Bodies This episode is based on an article developed by Wega Informatik AG and is intended to help MedTech professionals approach DHF remediation in a controlled, transparent, and compliant way.If you are responsible for design controls, quality systems, or regulatory compliance, this episode will help you avoid costly mistakes and build confidence in your remediation approach.LinksRichie Christian Linkedin: https://www.linkedin.com/in/christianrichie/Social Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldevice

In this episode of Medsider Radio, we sat down with Greg Walters, co-founder & CEO of Excision Medical. Excision is developing a leaflet modification system to enable lifetime management of aortic stenosis.Greg has almost 40 years of experience in cardiovascular devices, holding leadership roles at Kensey Nash Corporation where he led the development of Angio-Seal and several endovascular programs. He later co-founded Essential Medical, which was acquired by Teleflex in 2018, and is an inventor on more than 75 U.S. and European patents.In this interview, Greg discusses why early-stage teams should build to learn rather than to impress, using functional prototypes to generate real feedback and fundraising momentum. He outlines how disciplined safety work — not perfection — defines first-in-human readiness, and what makes a pre-revenue company attractive to strategic acquirers. Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.And if you're ready to level up your medtech game, you should check out Medsider Courses — 8-week masterclasses covering topics like fundraising, M&A and exit planning, design and development, clinical and regulatory strategy, and commercialization.These courses, featuring hard-earned lessons from elite medtech CEOs, can be purchased individually or come free with our All-Access Pass.If you'd rather read than listen, here's a link to the full interview with Greg Walters.

In this episode, Duane Mancini speaks with Matt Wunzin, a biomedical engineer from Ohio with nearly 20 years of experience in the medtech industry. Matt shares his career journey from earning his degree at the University of Akron to working at various medical device companies, both large and small, and also discusses his transition to consulting with his firm, Five Design and Development. He shares the importance of quality management and documentation in the medtech field, and highlights the opportunities available in Ohio's medtech ecosystem. Matt Wunzin LinkedInFive Design & Development WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedIn

Dr. Jenny Hoffmann, MedTech executive and author of Open Up: Step Into the Leader You Are Meant to Be, joins host Etienne Nichols to discuss the evolution of leadership in the medical device industry. Drawing from her experience as a bioengineer and CEO, Dr. Hoffmann explains why the traditional model of the "rigid, perfect leader" is no longer sustainable. She shares her personal journey—from being one of the first IVF babies in the U.S. to navigating life-threatening health complications—and how these experiences shaped her mission to help others lead with authenticity.The conversation centers on the concept of "SOS moments," which Dr. Hoffmann defines as those critical points of distress or crisis that occur in both personal lives and product development. By applying her CEC framework—Curiosity, Empathy, and Connection—leaders can transform these high-pressure moments into stories of strength. This approach is particularly vital in MedTech, where the ultimate goal is to serve patients during their own most vulnerable SOS moments.Etienne and Jenny also explore the intersection of human leadership and emerging technology. While AI continues to streamline technical workflows, Dr. Hoffmann argues that human empathy and curiosity remain irreplaceable assets for innovation. The episode concludes with a practical look at the return on investment (ROI) for "opening up," demonstrating how personal connection leads to higher quality products, better team retention, and the resilience needed to survive the "messy middle" of product development.Key Timestamps00:00 - Introduction of Dr. Jenny Hoffmann and her background in MedTech and innovation.01:28 - Motivation for writing Open Up: Scaling impact through vulnerable storytelling.04:23 - The shift from the "perfectly composed" leader to the vulnerable leader.05:45 - Dr. Hoffmann's personal origin story: Being one of the first IVF babies in the U.S.08:30 - Listening to the "whisper" and the courage required to respond to inner intuition.10:14 - The ROI of Vulnerability: How personal connection drives higher quality and team motivation.14:39 - Defining SOS moments: Turning distress signals into leadership strengths.18:42 - The CEC Method: Breaking down Curiosity, Empathy, and Connection.20:25 - AI in MedTech: Why human empathy is the one thing machines cannot replace.25:57 - Strategic Sharing vs. Oversharing: How to lead by example without losing professional boundaries.28:52 - The power of storytelling for engineers and data-driven professionals.Quotes"The leader is the first one to step out on the bridge that no one's sure if they want to cross. You paint that vision of the bridge, and then you're the first one to step out on it." - Dr. Hoffman"If we can put empathy first and think about how we are each a patient first... then we can uncover the real needs to

Is your medical device vision actually helping you grow - or silently holding you back?If you're a clinician founder with a working prototype but struggling to scale or export your medical device, the problem likely isn't your product — it's your vision. In this episode, Hakeem Adebiyi breaks down why most healthcare innovations stall commercially and how to fix it using a proven, clinician-friendly framework.Here's what you'll learn:Why your current vision might be too generic — and how that's stalling your commercial growthThe DAMP framework: a 4-step system to pressure test your vision for direction, alignment, motivation, and peopleA practical on-the-go exercise to sharpen your vision and guide real business decisions immediately

Fundraising isn't a pitch deck moment—it's a process. And if you treat it like a last-minute sprint, you'll lose more than equity.In this 5 in 5 episode, Hakeem Adebiyi shares five hard-earned lessons every founder needs when raising capital, especially at pre-seed, seed, or early Series A. From avoiding diluted equity to knowing what investors actually care about, this episode helps clinician-founders and MedTech entrepreneurs approach funding with strategy—not desperation.You'll learn how to:Approach fundraising as a structured process, not a one-off eventGet in front of investors without relying on warm introductionsLead with the problem—not the tech—when pitchingAvoid damaging credibility by targeting the wrong investorsUnderstand what investors look for right after they say “yes”Use preparation as your best defence against unnecessary dilutionWhether you're building a medical device, a healthtech platform, or preparing to scale internationally, this episode gives you the mindset and tactics to raise smarter and protect what you've built.