Podcasts about Medtech

Have you ever built a MedTech solution that clinicians praised, only to discover that praise doesn't automatically lead to adoption, funding, or sales?Many clinician founders believe that solving a genuine clinical problem is enough to guarantee success. Unfortunately, healthcare is full of innovative products that never make it beyond a pilot programme. In this episode, Jordan Morrison explains why adoption must be designed into your MedTech product from day one and how founders can avoid the common traps that prevent great innovations from reaching patients.Listeners will discover:Why solving a clinical problem is only the first step towards successful MedTech adoptionHow to validate whether clinicians will actually use, fund, and champion your productThe commercialization, funding, and adoption strategies that should be considered long before regulatory approvalPlay this episode now to learn how successful clinician founders turn clinical insight into commercially viable MedTech products that stand the best chance of real-world adoption.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.

Are you focusing on distributors, regulations, and trade shows before you've even confirmed that Japan is the right market for your MedTech product?Many MedTech companies approach Japan by immediately looking for distributors, regulatory support, or commercial partners. But as Hakeem explains in this episode, the most successful companies start somewhere else entirely. Drawing on key lessons from his conversation with Japan market expert Curt Jennewine, this episode explores how to evaluate market opportunity, avoid costly assumptions, and build a market-entry strategy that matches your resources and objectives.Listeners will discover:Why market understanding should always come before market activityHow Japan's quality expectations can strengthen your overall international businessThe key factors to consider when selecting distributors and planning your export strategyPlay this episode now to discover the lessons that can help you avoid costly mistakes and improve your chances of successfully exporting your MedTech product to Japan.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.

In this episode of Medsider Radio, we sat down with Eric Kau, co-founder and CEO of Climatic.Climatic is commercializing L Max, a daily inhaled system that proactively supports lung function.Before Climatic, Eric served as COO of Seed Health and was part of the foundational team at Chewy. Earlier in his career, Eric held growth and operational leadership roles across consumer, wellness, and e-commerce businesses, including Amazon, BoxyCharm, Target, and Best Buy. In this interview, Eric discusses what it takes to build a consumer category that doesn't yet exist, how Climatic approached clinical validation and consumer education simultaneously, and how early user behavior helped identify the company's strongest initial customer cohorts.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 Eric Kau, which includes a link to ScottBot — an AI version of host Scott Nelson trained on every Medsider interview and playbook. Feel free to ask ScottBot any questions you'd like!KEY MOMENTS FROM THE INTERVIEW(02:49) - Eric's path through Amazon, Chewy, Seed, and the consumer health experiences that led to Climatic (05:49) - Why Climatic is treating lung health like hydration, sleep, or nutrition (11:47) - How Climatic rapidly iterated on formulas, delivery systems, and prototypes to launch a product for a new category in under 2 years (14:56) - Climatic's approach to product design, which is built around gym bags, vanities, and existing wellness routines (19:59) - How early users shaped both Climatic's clinical strategy and its go-to-market focus on endurance athletes and biohackers (23:56) - Why Climatic spent more time teaching consumers about lung health than selling the product itself (34:07) - What investors needed to believe before funding a category that didn't yet exist (40:27) - How Climatic built a 15,000-person waitlist through Strava run clubs instead of paid ads

How can pharmaceutical, MedTech, and life sciences companies structure global operations capable of supporting sustainable international growth, regulatory consistency, and successful market integration?Global expansion is no longer only a commercial opportunity. For companies operating in highly regulated sectors, entering and integrating international markets requires strategic coordination between regulatory affairs, quality systems, supply chain management, local partnerships, risk governance, and operational execution.In this episode of International Pharma Talks, Dr. Diogo Sousa-Martins, Founder and President of ELS Group, explores the strategic role of Global Operations Management and the practical approaches companies should consider when expanding across different jurisdictions. The discussion examines how organizations can move from fragmented international activity to structured, resilient, and coherent global operations.You will gain a clearer understanding of:How global operations management supports international expansion in regulated healthcare sectors;Why regulatory alignment and local adaptation must work together when entering new markets;How supply chain visibility, traceability, and operational coordination reduce disruption and improve resilience;Why risk management, scenario planning, and diversified sourcing are essential in multinational operations;How harmonization frameworks, quality systems, local partners, and advisory support can help companies integrate markets more effectively.For pharmaceutical, MedTech, healthcare, cosmetics, food, and other life sciences companies, internationalization requires more than identifying market potential. It requires the ability to connect strategy, compliance, quality, logistics, and execution into one coherent operational model.When global operations are poorly structured, companies may face regulatory setbacks, supply chain disruption, increased costs, inconsistent quality, delayed market access, and loss of competitiveness. When they are properly designed, global complexity can become a source of resilience, operational predictability, and sustainable growth.Tune in to understand how practical Global Operations Management strategies can help companies integrate international markets, strengthen cross-border execution, and build scalable operations capable of supporting long-term success.Learn more at: https://www.els-solutions.com/This episode was recorded in 2026. Some information discussed may have been updated since the recording. The podcast was developed based on multiple bibliographic sources. The views expressed reflect the professional experience of ELS members and the referenced materials consulted.#ELS #ELSGroup hashtag#Podcast #InternationalPharmaTalks #GlobalOperations #OperationsManagement #InternationalMarkets #MarketEntry #InternationalExpansion hashtag#Pharma #MedTech hashtag#LifeSciences #Healthcare #RegulatoryAffairs #SupplyChain hashtag#RiskManagement #Compliance hashtag#BusinessStrategy

Why Medtech Commercial Strategies Stall and How to Fix Them One of the most common and costly mistakes in medtech commercialization is confusing clinical buy-in with commercial buy-in. A surgeon who loves your device, peer-reviewed data supporting it, and a field rep with a 20-year relationship can all be in place, and the deal can still stall out completely. Why? Because the doctor is not the buyer. On this episode host Adam Turinas sits down with Todd Laderach, a medtech commercial strategy veteran with over two decades of experience across sales, marketing, and go-to-market leadership. Todd now runs his own firm helping device companies get life-saving products off the shelf and into the hands of clinicians, and he brings a clarity to the commercial realities of medical device selling that I think will resonate well beyond the device world. Find all of our network podcasts on your favorite podcast platforms and be sure to subscribe and like us. Learn more at www.healthcarenowradio.com/listen/

Are you spending time evaluating distributors, regulations, and trade shows before you've even confirmed you're targeting the right export market?Many MedTech companies assume international growth starts with finding distributors or navigating regulations. But the reality is that choosing the right market is often far more important than deciding how to enter it. In this episode, Hakeem breaks down the lessons from his conversation with Japan market expert Curt Jennewine and explains why market understanding should always come before market activity.Listeners will discover:Why market selection is often more important than market entryThe three key questions every MedTech company should answer before exportingHow to avoid costly mistakes that waste time, money, and momentum when expanding internationallyPlay this episode now to learn how to identify the right export markets for your MedTech product before investing valuable time and resources into expansion.This one is particularly strong because it reinforces your core positioning around MedTech exporting while giving listeners a practical framework they can apply immediately.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.

MedTech innovation succeeds when bold ideas are matched with disciplined execution, strong teams, and a clear purpose. In this episode, James Corbett, transformational MedTech CEO and Board Advisor, joins Saul to share the leadership lessons, operating principles, and industry changes that have shaped his decades-long career. Drawing on experience leading companies including Boston Scientific, ev3, Alphatec Spine, CathWorks, and AVITA Medical, Jim explains why people and purpose are the foundation of lasting success in healthcare. He discusses the future of MedTech, including the creation of new clinical categories, the importance of operational excellence, and the growing role of AI in leadership and business transformation. Jim also shares why many organizations are underutilizing AI, how his AI command center captures decades of operating knowledge, and why great people remain the ultimate competitive advantage. Tune in and learn how purpose-driven leadership, operational discipline, and AI-enabled execution can help shape the next generation of MedTech innovation! Resources: Connect with and follow James Corbett on LinkedIn. Explore Jim Corbett AI!

AI can analyze data faster than any human—but strategy still requires judgment. In this episode of Med Tech Gurus, we sit down with Joe Luminiello, Founder and CEO of RCG Intel, a competitive intelligence firm operating at the intersection of healthcare, biopharma, and AI-driven decision making. With more than 40 years of life sciences leadership experience—including helping launch Takeda's Canadian business and leading a 650-person commercial organization responsible for over $1B in annual sales—Joe brings a unique perspective on what separates data from real strategic insight. Joe explains why many life sciences companies struggle to translate information into action. While AI can rapidly analyze clinical data, market signals, and competitive activity, it cannot replace the contextual intelligence that comes from human conversations with physicians, key opinion leaders, and frontline healthcare professionals. We explore how commercial teams can avoid the common disconnect between product development and market strategy, why cross-functional communication is critical for successful product launches, and how companies can use AI to enhance—not replace—human decision-making. If you're a MedTech founder, biotech executive, investor, or commercial leader navigating AI, competitive intelligence, and product commercialization, this episode offers powerful insights into turning data into strategy and strategy into execution.

One of the hardest parts of auditing is not knowing what to look for.It is deciding where to start. Do you trace a deviation? Walk the process? Focus on one department? Audit CAPA across the organization? Or pull on a thread that does not quite make sense?In this video, Subhi walks through six audit strategies from the ASQ Certified Quality Auditor Body of Knowledge and explains how they apply in real-world pharma, biotech, and combination product audits.The six strategies covered are:1. Tracing2. Process Approach3. Process-Based Management4. Department Method5. Element Method6. Discovery MethodThese approaches are useful whether you are auditing a supplier, a manufacturing site, a testing laboratory, or a quality system that spans drug, device, and combination product responsibilities.Need support with combination product quality, auditing, supplier quality, or quality system strategy?Schedule a Let's Combinate intro call:https://calendly.com/letscombinate/let-s-combinate-intro-sessionLearn more about Let's Combinate:https://letscombinate.comPreparing for the CQA exam?Check out the CQA Master Class here:https://cqeacademy.teachable.com/p/the-cqa-master-class-courseChapters:00:00 Six Audit Strategies Overview01:12 Tracing Method Explained02:59 Process Approach Workflow04:27 Process-Based Management05:46 Department Method Deep Dive06:27 Element Method Across the QMS07:12 Discovery Method: Pull the Thread08:55 Summary: Pros and Cons11:31 Final Tips and Next StepsSubhi Saadeh is the Founder and Principal of Let's Combinate, where he helps teams develop and control drug-device combination products by aligning quality systems, development, and regulatory expectations across drug and device domains. He is a consultant, auditor, trainer, and speaker with experience across pharma, biotech, medical devices, and combination products.#Pharma #Biotech #Quality #Auditing #QualityAudits #CQA #GMP #CombinationProducts #QualitySystems #ISO13485

Have you ruled out Japan because you've been told it's too difficult, too expensive, or takes too long to enter?Many MedTech companies overlook Japan because they assume the regulatory process is complex, the culture is difficult to navigate, and market entry requires significant resources. But the reality has changed. In this episode, Japan market expert Kurt Jenewin explains why many of the traditional barriers are no longer as challenging as they once were and what MedTech companies need to understand before entering one of the world's largest healthcare markets.Listeners will discover:Why success in Europe or the US doesn't automatically guarantee success in JapanHow Japan's regulatory, reimbursement, and distributor landscape has evolved in recent yearsWhat MedTech companies should look for when selecting partners and building a successful export strategy for JapanPlay this episode now to discover whether Japan could be a faster, more accessible, and more commercially attractive export market than you think.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.

In this episode, Dr. Malcolm Townes breaks down how WashU is building a more execution-focused commercialization engine through its Gap Fund, designed to advance non-drug, non-therapeutic technologies by funding the technology (not startups) to avoid conflicts and drive sharper development decisions. He shares why hands-on, milestone-based funding and rigorous customer discovery are essential to uncovering “unknown unknowns,” preventing expert blindness, and aligning products with real clinical workflows. The conversation also explores how WashU leverages EIRs and Venture Fellows to add commercialization horsepower, why “coachability” is the strongest predictor of success, and what innovators most often miss: FDA clearance isn't enough—market access and reimbursement require different proof, data, and strategy.Dr. Malcolm Townes LinkedInWashington University in St. Louis Gap Fund WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law and JumpStart Inc.

Dr. Amel Havkic, founder and Managing Director of EvoMed Consulting and a practicing physician, unpacks why so many amazing medtech solutions never reach the patient bedside, along with advice on how to change that. Driven by frustration from frontline care, Amel built EvoMed to guide companies from development through real-world clinical adoption, and shares how his MBA research became the StarMap framework: seven success factors spanning workflow alignment, implementation friction, ecosystem fit, quality of care, and economic viability. He explains why staying in clinical practice matters as medical knowledge rapidly evolves, offers a real example of digitalization increasing clinician burden, and discusses AI as “augmented intelligence” that supports—not replaces—human decision-making.  Guest links: https://evomed-consulting.eu/ | https://www.linkedin.com/in/a-havkic/ | https://www.instagram.com/evomed_consulting?igsh=aTlyaGVmeXYybGt3 Charity supported: Save the Children Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com.  PRODUCTION CREDITS Host & Editor: Lindsey Dinneen Producer: Velentium Medical   EPISODE TRANSCRIPT Episode 082 - Amel Havkic [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 my guest, Amel Havkic. Amel is founder and MD of EvoMed Consulting, Department Head for Weaning and Home Ventilation. Dr. Amel is also a consulting medical director for many companies, apart from being an educator, mentor, author, and currently working physician. All right. Well thank you so much for being here. Welcome to the show. I'm delighted to talk with you today. [00:01:23] Amel Havkic: Thank you so much. It's a pleasure being here, and thank you for having me. [00:01:27] Lindsey Dinneen: Of course. I'd love if you wouldn't mind starting off by sharing just a little bit about yourself, your background, and what led you to medtech. [00:01:37] Amel Havkic: Okay, so my name is Amel Havkic. I am still a practicing physician. But on top of that, I'm a advisor in medtech. I am in medtech since something like six, seven years, and it actually came from the frustration that I had in everyday work on the patient bedside. I was already consulting some medtech companies on specific topics. And I've seen this huge gap between amazing medtech solutions which, however, for whatever reason, never made it to the bedside. So I ended up, I ended up fund founding EvoMed Consulting consultancy, which helps medtech companies with clinical adoption, pretty much helps them guide from the development all the way to the patient bedside. The solutions really getting adopted, really having an impact. We've had quite some success with this. We've been named best Market Access Consultancy in '25 in medtech. I personally also celebrated recently award for Best Rising Star of the industry. And yeah, all of this came from the idea that I wanted to see a world where no patient is left behind and independent of geography or economy or economic status. Every patient gets the best care imaginable. And yeah, what better way to deliver that than medtech, right? [00:03:05] Lindsey Dinneen: Yes, that was the perfect plug for medtech right there. That was excellent. So first of all, congratulations on all of your success and these recent achievements. That is really exciting and incredible and I, I know that your motivation goes obviously so much deeper than that, but I love the fact that you're getting recognized and it's, it's nice to have those moments of affirmation, so. [00:03:31] Amel Havkic: Yes, it is. I said it on the interview, which I got after the, after the award. It's not even about the award itself. It is actually about what I stand for and that is the human side of medtech. I mean, it is technology, but we're still doing it for humans. And as a doctor getting recognized and not as a founder, it is something it, it is a signal. So that's the, I think that's the positive, the good part about it, and that's what makes me proud. [00:04:03] Lindsey Dinneen: Yeah. Yeah, absolutely. So did you always have an interest in medicine? Did you always think you were gonna go this route? [00:04:11] Amel Havkic: In medicine, yes. I think as far as I can remember, thinking I wanted to be, I wanted to be a doctor. I was trying to cater to wounded animals as a, as a kid with, I don't know, four or five, six years old. Then I went to med-- no, before I went to med school, I was doing basically nursing school. I grew up in Bosnia, in Sigovina There it's after eighth, eighth grade, you decide what you actually want to do. So I decided I wanted to go into medicine and at that time, Dr. House came out and or house MD in, in the English, English terminology. And I was a huge fan. So that was pretty much my, my route was set from that. I was al also always tech savvy, so if I wouldn't have done medicine, I would've probably done IT. And at one point it kind of merged. [00:05:09] Lindsey Dinneen: Wow. Okay. All right. So Dr. House, I can totally understand why that became an, an inspiration. Do you have any examples that you could share that are like, is, is the medical world ever as wild as some of those stories on Dr. House? [00:05:27] Amel Havkic: Oh yes. Oh yes. It is specifically. So besides working in the hospital, I work in a private practice, and funny enough that private practice is focused on difficult to diagnose and rare diseases of, obviously for, for that reason. I was also working in a hospital department, which was working with with or in discovering rare diseases specifically when it comes to, to respiratory diseases. So, yeah, it is like that. I can share a story of one patient, which came to me because she had thoracic pain every now and then. And it was reoccurring, came again and again. I did an ultrasound, and so she was at a cardiologist, she couldn't find anything. The, the whole thing. And it, I did an ultrasound of the chest and I found a, a little a little mass, which is not supposed to be there. So I sent her to a CT. Funny enough, the CT came back negative because it was so small that you couldn't see it on a ct. However, when you know exactly where to look, you could still like see outlines of it. And then in the, in the discussion came out that she had an endometriosis at one point. So, we said, "Okay, this might be somehow connected." We took a tissue sample, so in the end it was indeed an endometriosis, which got discovered after 20 plus years of or, or 10 years of, chest pain every now and then. So, it's just one of the examples of the, of the, so yeah, it's Dr. House specifically is quite realistic. [00:06:57] Lindsey Dinneen: Oh my goodness. That is wild. I, wow. Okay. That is, that is really cool. So, so do you also have these these moments, I could just imagine you just feel like you've solved a mystery and you can help this patient and you know exactly how, is that just like the best feeling? [00:07:13] Amel Havkic: For, for me it is, for me, it is, I always have to describe or, or tell to my assistants in a or, or not assistants, my residents. Please don't misunderstand me. I get excited by this, not because I want the patient to be sick, but because first of all, we find a way to help after so many people could not. And yeah, just for the pure love of the game, so to say. [00:07:37] Lindsey Dinneen: That's amazing. Okay, so, well, I feel like we can go off on many tangents, but I'll, I'll try to, I'll try to stay focused because I, but I love that. I love that. So you're a practicing physician and you're, you're seeing these instances of medical technology that I imagined isn't getting adopted in the way that you know it should, that would have clients or patient impact. So you're, you're seeing this for a while. So did that lead to direct opportunities to consult for some of these companies that needed a physician's perspective or how did, how did that go from, "Hey, I, I, gosh, I'm seeing this gap" to, "Okay, I know where to go from here." [00:08:19] Amel Havkic: So, it exactly like that. So I was brought into a medtech company to consult them as a clinical medical expert on, at that point, risks associated to their solution. Of course it makes sense to have someone who is still in the trenches, so to say, because the logic behind certain workflows in hospitals or in healthcare environment is not the same logic that it guy would have when talking workflows similar. So that's how it started. And then a pattern started emerging. When I did my MBA thesis, I basically took, took these two, these two, that, that gap that I saw and made it a topic of my MBA thesis. I was looking specifically on success factors in healthcare and what makes a solution gets adopted or delivery system healthcare path, what makes it get adopted in the real world and what does not. And what emerged was basically knowledge graph constellation, so to say, of seven success factors. And that constellation also showed how they're connected with each other, so, and how they interact how they impact one another. So I put that to the, to the to the test, the findings, running multiple times the most profitable hospital unit in basically every hospital I went to, starting my private practice, which got profitable from day one. Consulting clients on the same on the same, framework who were able to triple their, their revenue from 30 to 90 million. And so on, so forth. And ultimately then just about half a year ago, I made the framework public, and that's the StarMap framework which is the moment when everything kicked off. So everything I I said after all the awards and all the recognition came after I shared what I've been holding back up until that point. [00:10:25] Lindsey Dinneen: Okay. Alright. Wow. All right. Can you share a little bit about this framework and what makes it so unique and impactful? [00:10:34] Amel Havkic: So what the eye recognized is that it works because it's basically backwards engineered. I had the benefit of hindsight and had the benefit of seeing the solutions, which really made it to, to the patient bedside. So this is a challenge that many medtech companies, specifically the medtech startups face. You know, they come actually from the other side trying to pick one of the hundreds, if not thousands of ways to to, to navigate, to come to that one point where they want to be. For me, it was exactly the other way around. I was already where they want to be and was able to backwards and engineer those factors. And it is, when you think about it or when you read through it, it's almost common sense. Factors like specialization, cooperation and ecosystem fit, workflow alignment, predictability of services. But also implementation, friction digitalization, quality of care, and specifically economic viability. So pretty much a 360 view on the, the, on the solution because when you, when you come to think of it, for something to get adopted in the clinic, there is a lot of different stakeholders involved. So it's not just the doctors, it's not just the clinics, it's the insurance companies, it's the the procurement, IT. Does this at all integrate into my ecosystem and so on so forth as a whole bunch of stakeholders and questions that need to be answered. And the StarMap is the first framework, which basically has a, a structured way of looking through all of these. [00:12:16] Lindsey Dinneen: Okay. Yeah. So this is, this is a framework that you have, I imagine, developed and refined over time as you've been consulting. So when you first started consulting, what are some of maybe the lessons that you learned in terms of being able to really help these companies succeed? [00:12:35] Amel Havkic: This is a bit more of a personal one because, I founded a consulting company. So my thought I had, I have no clue about marketing. I have no clue about those things. I'm a doctor, right? So, I imagined that what I should be is a consultant, right? After all, I'm consulting. It turns out that the, the biggest impact I could make, in fact as a doctor, because in the end, that's what I am, it's what is most natural to me, and that is what is bringing most impact to the clients. And then there's one specific thing which I have, which many other consultants in healthcare, also good consultants, don't have. And it is the fact that I'm still practicing. Fact is that today medical knowledge doubles every 73 days. In theory, that means if you are out of the healthcare delivery for 73 days, your knowledge is almost obsolete. It was way less, it was a few years when I studied. And now it's, it's became so exponentially big. What that means is that if you would take a doctor, and make him a consultant, drag him out of the hospital, he would be an expert for 73 days, and that's where it would stop. And this is the, this is pretty much the, the mindset that I adopted and everyone consulting in the EvoMed is still a practicing, practicing healthcare practitioner. So yeah, that's what makes EvoMed specifically different and that's how I saw the world before and how I see it now. [00:14:09] Lindsey Dinneen: That's incredible. Okay. Yeah. And, and it makes so much sense that if you're practicing then you're, you're needing to keep up on all that. But just on a very practical level, how do you stay on top of so much new information coming out so regularly? I mean, it's not like, you know, you don't have three major career things going on right now. [00:14:33] Amel Havkic: Yeah, I think by now it's a flywheel, and luckily I, I am the very, in the, in the very lucky position that my, that my hospital knows and accepts what I'm doing outside of the hospital and also supports this. So, I get updated regularly through through people talking to me, reaching out to me, showing their solutions, asking for my opinion. And on the other side, so, so that's, that's what keeps me updated on a regular. And on the other side, I still I still see the challenges that you would have in a hospital implementing those solutions. So, recently the one specific thing happened, just as an example. We, I, I was involved or I'm involved in a digitalization pro project of an ICU and of operating room. For that they have now from, from paper, from from paper notes, they're switching to digital. Problem is the paper notes they could fill out within five minutes while the digital have all kinds of mandatory fields. And, and it's kind and, and the time it takes a physician to fill out those, those digital forms is six times... [00:15:47] Lindsey Dinneen: Hmm. [00:15:47] Amel Havkic: ...More, so it's 30 minutes roughly if you're fast. So although you would think that something which gets digitalized is automatically better, this specific thing proves that just because someone thought, okay, I need this information, it need, this needs to be mandatory. But because the system maybe doesn't communicate with other parts of the system, legacy systems, legacy data from somewhere, it makes the job of the doctor living hell. So you, you can imagine how it is when you have like one person doing, I don't know, 40, 50, 60 pre-medication a day, and then from like five to 10 minutes pre-medication, it goes to 30 minutes, 60 minutes. That's, that's a problem. [00:16:31] Lindsey Dinneen: Yeah. So yeah, that is, that's, that is so interesting. It's, it's kind of, I suppose that goes into a lot of innovation. There are sometimes, you know, the things that we think, "Oh, well, this is, this is progress" and, and it might be, but just because you can doesn't mean it's always perhaps the most efficient or we should at least stress test it and decide, you know, how to make it the best it can be. So, all right, what are some, what are some trends and innovations that you're seeing that you're really excited about in terms of the future of medical care? [00:17:08] Amel Havkic: Well, obviously AI is a, is a great trend. I am really hoping that it'll take the, the proper route. I am, I've, I've been saying this a lot and I will repeat it again. When I say AI in healthcare context, I don't like AI as artificial intelligence, but as augmented intelligence, because what it's supposed to do, it's supposed to support our natural decision making process. And a decision in a high stakes environment like healthcare still needs to be in the hands of humans because there's much more to it than just a simple yes or no, or a statistic, or it's most probable that and that is a trend. So, so that is a technology which has huge potential. But so far, I must say oftentimes I see it implemented in the wrong way. It's trying to automate certain things either not good enough, or at certain points, or in such a way that it's not a livable in daily life or meets resistance. Specifically in healthcare, it's a very inert system because innovation in healthcare is perhaps dangerous is, it introduces new risks. That's why healthcare evolved to be a very inert system and to resist changes unless those changes are definitely proven to be better than what we have right now. So as an example, we had IBM Watson Oncology, huge player, huge possibilities. But somehow the, the way that Watson Oncology did things was not the way that clinicians wanted to use it. So in the end, they ended up selling it off. And that is just one example of many, many. So what I would really like to see for the future is AI is augmented intelligence, which really is positioned at the right places in a workflow of healthcare practitioners and help support their decisions rather than trying to automize or making them obsolete. [00:19:24] Lindsey Dinneen: Yeah, that makes a lot of sense. And it's, it's something that of course we hear a lot about, you know, and, and a lot of times I think that what I've been hearing, exactly like you said is, you know, if it can help, if it can help minimize some workflows or make something more, a process more efficient or those kinds of things, that is great help. But I don't think anyone wants AI to replace the expertise and the hands on learning that you do. And, and you obviously every 73 days, like you said, you're constantly building up your, your knowledge bank. And literally having been in the, in the medical setting for so long, you've, you've gotten to see this play out in real life and AI can't do that. So yeah, that's really interesting. [00:20:12] Amel Havkic: True. What, what it can do however, is just like every other job, healthcare also has a bell curve. So you have 5% or a percentage of the practitioners who are massive under performers, a percentage which are massive over performers, and then there's an average in the middle. And what, what AI can do is it can help even out the bell curve and move it as far to the expertise side as possible. There's also other repetitive tasks which, which can be taken over. So I do see potential in the, I do see a lot of potential in that technology specifically. But just as another example in my private practice, I have a. I have a AI scribe. It is specific for medtech. It's not something that I misuse, foreseeable misuse, for all the regulatory people. But it is an AI scribe. Still, most of my colleagues are not using it because they say, "Okay, this does not fit our needs. And it is not that specific scribe that we use." You cannot tweak the way how it gives you the output. It's preset. You can optimize certain things, but you cannot, for instance, train on your on the way you like your letters to look, for example. Then there's errors. So although you think, "Okay, you save a lot of time typing," right? You add at another point another a few work steps with the solution and ending up being shelved again because it's not really helping. Although from the, from the first glance, on the first glance, you would think, "Okay, this is revolutionary." [00:21:55] Lindsey Dinneen: Hmm. Yeah. Yeah. Okay that. Yeah. So it's gonna be interesting to see how it evolves and how it becomes hopefully even more useful in the future. So are there any moments that along your journey, either as a physician or even as a consultant, are there any moments that really stand out to you as affirming, "Wow, I am in the right place at the right time." [00:22:23] Amel Havkic: So it happened on, so speaking of the doctor part, yeah. It happened to me quite often. And I was first thinking of it as having bad luck. But ultimately maybe I was supposed to be there. So for some reason I run on a regular, into, into big car accidents happening. And car accidents or motorcycle accidents or so on, so forth, at least maybe 6, 7, 8 of them through, throughout my life with people really being injured and me being there as a first responder. So, so those were for instance, moments where I thought, "Okay, well, I understand this happens once or twice," but now and, and keeps keeps getting more. It's a bit maybe I wouldn't say well, it, it seems that I am supposed to be there at that time. That's how it feels to me. On the, the consulting side as well, specifically now that medtech is gaining more traction and more impact, and also with the award recently and similar things happening, that also made me feel like, "Okay, maybe I can with this make impact on more lives than just the lives I treat directly." Because if you manage to help a medtech startup launch a revolutionary idea and then survive and really make it all the way to the market and then thrive there, you impact thousands hundred, thousands, maybe millions of lives. And the, it being accepted the way it is right now is for me as well a similar sign. [00:24:05] Lindsey Dinneen: That's really cool. Yeah. I, I think, you know, I, I talk about it a lot. My role within medtech industry, you know, is, is small. I don't have that same level of impact at all. I'm, I'm helping, I'm, I'm in marketing, so I'm helping people tell their stories and get the, the word out. But I think getting to even just think about the fact that no matter kind of where you fit into the ecosystem you're helping hopefully impact patients' lives for the better and it's, it's so special getting to feel like even though it's a small role, I got to play a role. Yeah. [00:24:42] Amel Havkic: It is a, i I wouldn't even downplay it that much to be honest, because if no one hears about the solution, if no one knows that it exists there's more and more and more we're getting overloaded with all kinds of information. So, marketers who help certain things break through and reach the right people are doing their share just as anyone else in the industry is. It's maybe just as important. So yeah, I, I would encourage you to continue what you're doing up until now. [00:25:12] Lindsey Dinneen: Well, thank you. That's, that's, that is very encouraging. Okay, so, pivoting the conversation a little bit. Just for fun. Imagine that you were to be offered a million dollars to teach a masterclass on anything you want. It could be within your industry, but it doesn't have to be. What would you choose to teach? [00:25:31] Amel Havkic: Oh, that's a relatively easy one for me. I would teach clinical adoption masterclass and clinical adoption simply for the reasons we already mentioned. I would really like to help good solutions survive the reality of everyday clinical life. [00:25:50] Lindsey Dinneen: Amazing. [00:25:51] Amel Havkic: I think survive is the right, right word for this. [00:25:54] Lindsey Dinneen: Yes, I think so too, especially in having conversations with startups that are currently in the midst of this and, and trying to navigate the best approaches. So, yeah. That's incredible. Okay. And how do you wish to be remembered after you leave this world? [00:26:11] Amel Havkic: Well, that's a more difficult one. How do I wish to be remembered? Well, I would like to be the, so I would like to be the guy who everyone thinks left the world a better place than I found it. Maybe, quite short, not that extensive, but the implications are huge. You know, you can make the world better in many different ways. I do have certain skills and talents which naturally got me to where I am today. But it ultimately doesn't matter how much better the world is after I'm gone as long as it is better and this became clear to me also recently. So, while the, the awards night was going on, my wife couldn't come with me because our kid got sick, so she stayed in a hotel and, but they were watching the live stream and in the amidst of it all, when, when I came up and I went front to get the award, the little one got up, although she was sick and she was like laying in bed all day and couldn't get up. She went to the screen and pointed to the screen. So yeah, ultimately I want also my my daughter to think of me as someone who made this world a better place one way or the other. [00:27:29] Lindsey Dinneen: Yeah. I love that. That's a beautiful legacy and yeah, you're, you're doing just that, so that's amazing. That is so amazing. Okay. Okay. And then final question, what is one thing that makes you smile every time you see or think about it? [00:27:48] Amel Havkic: Oh, that's also an easy one for me. It's definitely my daughter, also my wife. It's, yeah, it's an amazing it's, it's amazing just seeing her growing up and develop all of these new skills and all of the new things that you didn't, that she didn't know how to do the day before. Also the way she goes through the world. She's fascinated by everything. Everything around is somehow magical and new and, yeah, so she can just like sit, sit in a, in a baby carriage and look around and everything is so, so awesome. She doesn't even need more. And that makes me remember that we actually should be more, way more, way more aware of the world around us and maybe not so, rushing all the time. [00:28:39] Lindsey Dinneen: Mm-hmm. Yes. I, I love that. I think I think about this sometimes of the idea of everyday magic, and those are just those moments of, I don't know, a butterfly, you know, flying by and you just see how beautiful its wings are or, you know, nature is, is very much that way for me in general. I, I, you know, you go on a walk and you go, "Oh my gosh, you know, those, those daffodils weren't there yesterday, and how beautiful are these things?" And to me, that's everyday magic. [00:29:09] Amel Havkic: Well, it, it is, and we, I, I do think that we don't take enough time to appreciate it. With always being busy with what's in the future, where we have to be and what we still have to do, that we maybe forget sometimes to appreciate what's right in front of us. [00:29:25] Lindsey Dinneen: Yeah. Yeah. I love that. Well, this has been a wonderful conversation. I'm so thankful you joined me today. Thanks for sharing your time and your experience and your stories. We are so honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational, and safe environment. So thank you so much for choosing that charity to support, and also thank you for continuing to work to change lives for a better world. We're grateful, and I wish you the most amazing continued success. [00:30:06] Amel Havkic: Thank you so much. It was a pleasure being here and looking forward to part two. [00:30:12] Lindsey Dinneen: Yeah. There you go. Alright, well thanks again and we'll talk again later. [00:30:20] 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.

A non-invasive Alzheimer's therapy is moving closer to patients, and it could reshape how brain health is treated. In this episode, Christian Howell, CEO of Cognito Therapeutics, joins Saul live at DeviceTalks Boston to discuss how the company is advancing a novel Alzheimer's therapy that uses sensory stimulation through light, sound, and touch. He shares insights from Cognito's HOPE study, the largest non-pharmacologic clinical trial in neurodegenerative disease, involving 673 participants across 70 sites. Christian explains why a strong evidence strategy is essential not only for regulatory approval but also for reimbursement, clinical adoption, and patient access. He also reflects on leadership lessons centered on service, humility, humor, and the importance of aligning stakeholders across the healthcare ecosystem to improve Alzheimer's care. Tune in to hear how Christian Howell and Cognito Therapeutics are working to bring new hope, stronger evidence, and a more accessible path forward for Alzheimer's patients and families! Resources: Connect with and follow Christian Howell on LinkedIn. Follow Cognito Therapeutics on LinkedIn and explore their website.

Have you ever experienced a failed pilot, rejected investor pitch, or disappointing commercial outcome and wondered whether you're cut out to build a MedTech business?Many clinicians spend years training in environments where mistakes must be avoided because the consequences are significant. But building a MedTech company requires a completely different relationship with failure. In this episode, Hakeem explores why setbacks are often the fastest route to growth, how resilience is developed, and why many of the world's most successful innovations emerged from ideas that didn't work the first time.Listeners will learn:Why failure is often a critical part of becoming a successful clinician founderHow setbacks build the resilience needed to lead and grow a MedTech companyHow to turn rejected pitches, failed pilots, and commercial challenges into valuable learning opportunitiesPlay this episode now to discover why learning faster—not avoiding failure—may be the key to building a successful MedTech business..Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.

Health economics is not just about reimbursement. It is about proving how a technology reduces the total cost of care. In this episode, Betty Tsai, President of Cardiology Services International, explains why medtech companies must think beyond existing CPT or MS-DRG codes when shaping their commercialization strategies. Speaking with Saul at the MedTech Innovator event, she highlights how health economics reveals the true cost of a patient journey, from initial admission through readmissions and long-term care. Betty explores how value-based care and CMS performance metrics are reshaping hospital revenue and influencing adoption decisions. She also discusses alternative reimbursement pathways, such as the New Technology Add-on Payment, and emphasizes that companies demonstrating both clinical and economic value are more attractive to providers and investors. Tune in and learn why proving economic value may be one of the most important steps in driving medtech adoption. Resources: Connect with and follow Betty Tsai on LinkedIn.

Have you ever received great feedback on your MedTech product, only to discover that positive conversations don't translate into adoption?Many MedTech companies assume that solving a genuine healthcare problem is enough to drive adoption. Unfortunately, that's rarely the case. In this episode, Hakeem explains why customers only act on problems they see as priorities and shares a practical four-step framework to help you assess whether your solution is likely to secure attention, budget, and adoption.By listening you'll discover:Why solving a healthcare problem doesn't automatically create demandHow to determine whether your target customers see the problem as a genuine priorityA simple framework for identifying the people, consequences, and behaviors that drive adoption decisionsPlay this episode now to learn how to identify whether you're solving a problem customers can live with—or a priority they can't afford to ignore.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.

Engineering a solution is one thing; making it work in a high-stakes clinical environment is another. This panel discussion features the minds who build the tech and the hands that use it. Leading bioengineers and frontline clinicians from NYU, NYU Abu Dhabi, the University of Michigan and the University of Maine deconstruct the challenges of medical device innovation. The topics include glaucoma and other chronic diseases such as metabolic, cardiovascular, and neurologic diseases. The discussion also touches on AI, robotics, and wearable technology to improve patient care. Panel Members Andreas Hielscher, Professor of of Biomedical Engineering, NYU Tandon School of Engineering Shy Shoham, Professor of Neuroscience and Ophthalmology, NYU School of Medicine and Tech4Health Giovanna Guidoboni, Professor of Electrical and Computer Engineering and Dean of Engineering and Computing, University of Maine Manjool Shah, Clinical Associate Professor of Ophthalmology and Visual Sciences and Associate Chair of Innovation, University of Michigan Sefy Paulose Joshi, Assistant Professor of Ophthalmology, NYU Langone Health Moderated by Yong-Ak (Rafael) Song, Professor of Mechanical Engineering and Bioengineering and 19 Washington Square North Faculty Fellow, NYUAD

In this episode, Megan Shaw, CEO of the Pittsburgh Life Sciences Alliance, and Will Kaigler, co-founder and CEO of SovaSage, join the Project Medtech podcast to unpack what it really takes to build, scale, and ultimately create optionality in health tech startups. Megan shares her journey from being the first employee at HemoSonics to launching PLSA in 2024 to accelerate Pittsburgh's life sciences ecosystem. Will reflects on his experience with multiple startups, and explains how sovaSage is reimagining sleep apnea management to improve outcomes and lower costs. Together, they discuss why customer value—not fixation on an exit—drives success, how to hire the right early team without over-hiring, and why systems and rigorous user discovery can make or break a company. They close with a deep dive into Pittsburgh's unique strengths and upcoming opportunities to plug into the region's innovation community.Will Kaigler LinkedInMegan Shaw LinkedInsovaSage WebsitePittsburgh Life Science Alliance WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law and JumpStart Inc.

In this episode of Medsider Radio, we sat down with Kara Egan, founder and CEO of Teal Health.Teal Health is the company behind the first FDA-authorized at-home cervical cancer screening wand.Before founding Teal, Kara worked in healthcare and software investing at .406 Ventures and Emergence Capital, and held product and marketing roles at Zendesk and Stitch Labs.  In this interview, Kara discusses building support and follow-up into at-home screening, how Teal expanded its comparative clinical study to support broader market adoption, and how healthcare incentives, reimbursement, and institutional trust shape new care models.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 Kara Egan, which includes a link to ScottBot — an AI version of host Scott Nelson trained on every Medsider interview and playbook. Feel free to ask ScottBot any questions you'd like!KEY MOMENTS FROM THE INTERVIEW(02:49) - Kara's background in health technology investing and software that shaped Teal's consumer-first approach (05:14) - How Teal turned the traditional Pap smear into the first FDA-authorized at-home screening product (07:30) - Turning at-home testing, telehealth, and clinician follow-up into a single care experience (13:48) - Raising Teal's first $1M with mockups and consumer-grade design (22:17) - Teal's comparative study that matched physician-collected screening with 96% sensitivity (23:40) - How asking women what they actually wanted changed Teal's view of the market opportunity (32:05) - “Take off the healthcare hat” — Kara's framework for fundraising, incentives, and commercialization (41:48) - What investors actually care about beyond the company's mission

One of the most common and costly mistakes in medtech commercialization is confusing clinical buy-in with commercial buy-in. A surgeon who loves your device, peer-reviewed data supporting it, and a field rep with a 20-year relationship can all be in place, and the deal can still stall out completely. Why? Because the doctor is not the buyer.I sit down with Todd Laderach, a medtech commercial strategy veteran with over two decades of experience across sales, marketing, and go-to-market leadership. Todd now runs his own firm helping device companies get life-saving products off the shelf and into the hands of clinicians, and he brings a clarity to the commercial realities of medical device selling that I think will resonate well beyond the device world.We dig into why clinical validation is necessary but not sufficient, how to map a hospital buying committee and figure out who actually holds the yes, and how to arm your clinical champion to sell internally to stakeholders you will likely never get in front of directly. We also get into where commercial revenue gets stuck in mid to large device companies, how ABM applies in a world of complex IDN accounts, and where AI is genuinely moving the needle on account prioritization versus where it is mostly hype.If you work in medtech or want to better understand the device commercial landscape, this one is worth your time.Key Topics:"(00:00:00)" Introduction"(00:03:00)" Todd's background"(00:04:00)" The biggest shift in go-to-market"(00:05:00)" Why "the doctor said he'd use it tomorrow" is one of the most dangerous things to hear"(00:06:00)" Linking clinical benefit to economic outcome"(00:07:00)" Following the money"(00:08:00)" Arming the clinical champion"(00:09:00)" Anatomy of a hospital buying committee"(00:10:00)" Journey mapping stakeholders"(00:11:00)" Best practices for gathering actionable insights from sales teams and market research"(00:12:00)" ABM in med devices"(00:13:00)" The critical role of sales and marketing alignment"(00:15:00)" Is the field-rep-dominant model still fit for purpose? "(00:17:00)" Where commercial revenue actually gets stuck"(00:18:00)" Account prioritization"(00:19:00)" Breadth versus depth"(00:21:00)" AI in medtech commercialization"(00:22:00)" Using AI to make existing data actionable"(00:24:00)" Unlocking non-traditional data sources"(00:25:00)" What separates companies getting commercial strategy right"(00:26:00)" Four key takeaways from the conversationIf you are interested in discussing this or any other topic, let's have a chat.  Reach out to me directly to schedule a no-obligation discussion. This isn't a sales call, but rather an opportunity to talk through your questions and challenges.Follow me on LinkedIn.Subscribe to The Healthtech Marketing Show on Spotify or watch us on YouTube for more insights into marketing, AI, ABM, buyer journeys, and beyond!Thank you to our presenting sponsor, HealthcareNOW, 24/7 expert shows, interviews, and podcasts, powering healthcare leaders with innovation, policy, and strategy insights.

What started as a one-year break from surgery became a global medtech movement. In this episode, Dr. Dylan Attard, CEO and Co-founder of MedTech World, shares how his journey from surgical training to entrepreneurship led to the creation of MedTech World, now a global platform hosting events across Europe, Asia, the Middle East, and North America. What began as a single event in Malta has evolved into a multi-region ecosystem connecting startups, investors, and healthcare leaders. He highlights the strategic expansion into Florida, a growing yet underrecognized medtech hub, and emphasizes the importance of creating spaces where companies can raise capital and enter new markets. Dr. Attard also reflects on the personal “why” behind his work, sharing how exposure to cardiac innovations, especially after losing his father, reinforces the mission to accelerate life-saving technologies. Tune in to hear how Dr. Dylan Attard scaled MedTech World across continents, and the personal story driving his mission to accelerate life-saving innovation! Resources: Connect with and follow Dr. Dylan Attard on LinkedIn. Follow MedTech World on LinkedIn and explore their website!

Have you ever finished a busy week in your MedTech business and wondered whether you've actually made any meaningful progress?Many MedTech companies don't struggle because they're working too little. They struggle because they've confused strategy, planning, and execution. In this episode, Hakeem shares a simple four-step framework to help clinician CEOs identify the real challenges holding their business back, create a focused strategy, build an effective plan, and execute with purpose.Listeners will learn:How to identify the root cause of growth challenges instead of treating symptomsThe critical difference between strategy, planning, and executionA practical framework for turning business challenges into measurable progress over the next 90 daysPlay this episode now to learn how to stop being busy, start making progress, and build a MedTech business that grows with purpose and focus.Message me on Linkedin - 90 day template pleaseThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we're speaking about how to best determine the efficacy of regulatory and quality team members. A variety of real-world examples are provided that demonstrate the need to “trust but verify” the actions of these team members. During this conversation, the following questions are addressed:Why the need to measure the safety and efficacy of the regulatory and quality team?What can happen if you put too much trust or reliance on your regulatory consultant?Can you give a specific example where there was too much trust?Can you give us another regulatory example, perhaps involving clinical trials?Can you provide a quality or manufacturing example, perhaps involving AI?What are today's takeaways?Listen to this discussion and see if you need a plan to verify your regulatory and quality team members' actions. If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com, and we'll see if your ideas/inquiries/suggestions align with a future episode.Send us Fan Mail For more medtech news and information, visit https://www.mpomag.com. 

On this episode of the SPOT Radio podcast, Charlie Webb CPPL speaks with Jeff Devich BSME, MBA about the Sterile Start™ program, together they break down why so many medical device manufacturers struggle with the complexity of the ISO 11607 framework and how gaps in understanding can lead to costly delays, failed validations, and audit findings. They share real world insights, practical strategies, and clear explanations that help teams strengthen their sterile packaging programs and avoid common pitfalls.About Jeff Devich BSME, MBAJeff's background includes serving as Director of Operations for a combination of device contract manufacturers. He has extensive experience in equipment and process validation within the MedTech industry. Jeff applies his mathematic and engineering expertise to for the Sterile Start™ program creating Design of Experiments and characterization reports for Van der Stähl Scientific sealers, helping customers understand how process parameters affect their specific products. Email me: jeffrey.devich@gmail.comLinkedIn: https://www.linkedin.com/in/jeffrey-devich-1b6b2788

Dagens ämnen: 0:00 Intro 2:48 Sivers 12:04 Rymd 17:22 Octave 23:24 Medtech 25:33 Alphabet 30:40 Electrolux 33:38 Biotech 35:35 Iran 39:02 Lätt att dras med i hajpen 40:25 Veckans Fill or Kill www.instagram.com/fillorkillpodden   Tack RoboMarkets! https://open.spotify.com/show/7nqoFzFNOZHoQDUnrwKf4L     @RoboMarketsSE Tack @avanzabank! http://avanza.se 

Are you focusing on growth while ignoring the operational decisions that could quietly derail your MedTech business?Scaling internationally isn't just about entering new markets or adopting the latest AI tools. It requires operational discipline, strong leadership, and the ability to make difficult decisions consistently. In this episode, Hakeem shares the five biggest lessons from his conversation with Joshua Gould, CEO of The Big Word, and explains how MedTech companies can avoid the mistakes that often emerge during periods of rapid growth.You'll Discover:Why operational discipline matters more than speed when scaling internationallyHow to use AI as a commercial advantage rather than a marketing buzzwordThe leadership, compliance, and infrastructure decisions that support sustainable international growthPlay this episode now to discover five international growth lessons that can help you build a stronger, more scalable MedTech business and avoid costly expansion mistakes.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.

In this episode, Mark Domayhn, Partner at JD Lymon Group, joins Duane Mancini to unpack what medtech innovators often miss most: reimbursement isn't a box to check after FDA—it's the commercial foundation that determines whether hospitals and physicians can adopt your technology. Drawing on experience across Medtronic, Zimmer, and St. Jude/Abbott, Mark breaks down the “three-legged stool” of coverage, coding, and payment, why clinical evidence must satisfy payer standards (not just FDA), and how to “follow the money” across fragmented U.S. systems. The conversation then dives into the New Technology Add-On Payment (NTAP) program, why it matters for inpatient launches, how breakthrough designation has increased NTAP success, and the major implications of CMS proposing to repeal the alternative pathway—plus what companies can do before the June 9 comment deadline. Mark Domyahn LinkedInJD Lymon Group WebsiteRAPID Coverage Pathway InformationDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law and JumpStart Inc.

In this episode of Medsider Radio, we sat down with Karthik Ganesh, CEO of OnMed.OnMed is the healthcare technology company behind OnMed CareStation, a “Clinic-in-a-Box” designed to expand access to primary and urgent care. Before OnMed, Karthik served as CEO of EmpiRx Health, leading the company through rapid growth and a successful private equity transaction in 2021. Throughout his career, he's held leadership roles at QualCare, CareAllies, and Aetna, and advised healthcare organizations through Deloitte and EY.In this interview, Karthik discusses why hybrid care models still require a human touch, how enterprise healthcare buyers evaluate value propositions differently, why brand and culture should shape execution early, and how operating under constraints can sharpen innovation.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 Karthik Ganesh, which includes a link to ScottBot — an AI version of host Scott Nelson trained on every Medsider interview and playbook. Feel free to ask ScottBot any questions you'd like!KEY MOMENTS FROM THE INTERVIEW(03:04) - Karthik's obsession with healthcare access, and the “broken doorway” problem behind OnMed (05:51) - How OnMed combines telemedicine and brick-and-mortar care into a “Clinic in a Box” (09:04) - The OnMed metrics that surprised Karthik most, including a 37% patient return rate, and the reasons behind the company's success (09:22) - What OnMed designed differently after realizing that patients approach healthcare with their guard up (15:27) - The pitfalls of B2C healthcare and how OnMed was built as a B2B company by intention (22:01) - How Karthik reshaped OnMed around clarity, structure, and high performers (30:23) - What “brand” actually means to Karthik (39:37) - How OnMed tailored its value proposition for payers, providers, employers, and universities (45:45) - Karthik's fundraising philosophy: constraints keep companies inventive

Staci Miller, founder of Gen UX Consulting, shares her winding path from fashion design and psychology to human factors engineering in MedTech. Staci explains what human factors is—through stories from World War II aviation and modern healthcare—and why the FDA now mandates usability work to reduce catastrophic use errors. She breaks down formative versus summative/validation studies, the role of risk documentation (URRA/UFMEA), and why founders should think about usability as early as they think about risk. Staci also opens up about the challenge of starting a second business after losing her first in 2008, how she built Gen UX from $0, and the leadership lessons behind year-over-year growth.   Guest links: https://www.genuxconsulting.com/ | https://www.linkedin.com/company/gen-ux-consulting/  Charity supported: Feeding America Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com.  PRODUCTION CREDITS Host & Editor: Lindsey Dinneen Producer: Velentium Medical   EPISODE TRANSCRIPT Episode 081 - Staci Miller [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 as my guest, Staci Miller. Staci is the founder at Gen UX Consulting. Her expertise is in applying user-focused research to develop innovative solutions, and it's essential to the growth of any technology organization. As a detail-oriented and tenacious executive in human factors engineering and UX design, she has a proven record of elevating the end user experience and achieving targeted client outcomes. She has created innovative medtech and big tech solutions through a comprehensive user-centered development process, leveraging artificial intelligence and industry agnostic design tools to optimize products and services. In her current role with Gen UX, she's a key leader facilitating strategic company growth plans and service offerings while managing the capacity and workflow of the UX HF design team. Well, Staci, welcome to the show. I'm so excited to talk with you today. [00:01:49] Staci Miller: Me too. I've been looking forward to it all week, so I'm very excited to be here. And I don't know what the day has in store. I, I know that there was like a, a, a kit that you sent out and I didn't read it on purpose, so everything's gonna be organic. [00:02:03] Lindsey Dinneen: Perfect. Those are my favorite conversations anyway, so I'll take it and run. Some people I know really love to have the questions ahead of time, and others are just like, "Yeah, I don't want to know. I'm just gonna go off the cuff. Here we go." So, brilliant. All right, well, let's start, if you don't mind, by sharing a little bit about yourself, your background, and what led you to medtech. [00:02:24] Staci Miller: That is, those are my favorite questions. So, I have a background in fashion design, psychology. I spent most of my classes in cognitive psych, but it wasn't like a difference of degree, it was just psychology. And then I have a master's degree in human factors and ergonomics. So I went the psychology route and the design route. That's kind of my background. So when I graduated my master's degree, through my master's program, I was able to intern for both years and one was in tech, big tech. I interviewed and landed a, great one year long internship at Samsung, which was actually supposed to be just three months, and I stayed there for a full year. So they kept me through my whole, my whole semester, which is something they don't normally do, which was really fun. I mostly just said, "Hey, can I stay here for the year?" And they're like, "Great, no problem. Sure. We'll figure it out like that seems like a good option. We like you, you like us. Cool. We'll do that." And my second internship was in medical device at a company called Interface and Analysis. My, that was actually my internship. My second one was at Samsung, so I got to really look in like I, I guess you got the curtain. If you think about Wonderland and Oz and the curtain and being able to pull back the curtain between both industries, what did I like better? I ended up liking medical better, mostly because the research was more structured and not necessarily conversations about, "Yeah, so how do you feel about that? Did you like it?" Like to me, that's not really. What I would consider the best opportunity to gain data. Data to me, like there has to be like a clear objective as to what you're doing, the whys behind it, and what do you wanna learn. And I found that in, when I worked with engineers in medtech, they definitely had things that they wanted to learn, whereas in tech, they just had so much money. They were like, "Yeah, let's just see what people think about this." And I'm. Okay. And then when I would be really structured and I was working with people who didn't have backgrounds in research, had very strong, very good backgrounds in design, like legitimately awesome, they were leading the research and they were missing the boat. So the narratives started to be focused on the N of one. This one person said this really interesting thing, so let's base our whole design off of what they said. And I'm like, "Dude, wait a second. Wait a second. All of them said this thing about the design though, and like we have four or five data points about when you ask this question." They're like, "Yeah, but that's not interesting." And I was like, "Okay, keep my mouth shut. I got it. Move on." Like from that moment forward, I, it wasn't like "Staci, don't talk, it was more like this is how we design based on the narratives that we've learned how to, how to research on." And so it wasn't as I would say-- it wasn't considering the actual 360 view of the user. It was considering the really cool thing that happened this one time that was like totally an outlier. And it happened consistently when I was working in big tech. So I was like, uh, medtech, probably more my speed. And then my first job was at Abbott. [00:05:39] Lindsey Dinneen: Nice. [00:05:40] Staci Miller: And I ended up there. Yeah, [00:05:41] Lindsey Dinneen: Okay, great. Well. [00:05:42] Staci Miller: Cool. [00:05:43] Lindsey Dinneen: Lots of questions based on this incredible background. I want to go back a little bit. So fashion design, was this something that you grew up thinking, "Oh, this is what I wanna do and be okay?" Right. All right, so... [00:05:57] Staci Miller: it's all I ever wanted and I did that. So... [00:06:00] Lindsey Dinneen: Yeah. [00:06:02] Staci Miller: That's a, that's a great question. I think that my interest in fashion peaked around when I was 12 years old and during the time, Cindy Crawford and Naomi Campbell, and I was so fascinated by how beautiful these women were. And, and fashion was a thing in the nineties. There was like a lot of Dolce and Gabana around, and I loved it. And I couldn't wait to get my new print of Vogue every, every season. I loved Harper's Bizarre, and I would just pull pictures out of these models and what they were wearing. And then I would start you know, freehanding stuff and things like that. And I think a lot of people do that when they're really interested in clothing and things like that. And if you really think about it, fashion is art that people wear. So I was very attracted to that part of it. And it's all I wanted to do. So after high school, I went to FIDM and studied fashion design. And right outta FIDM, I started my first company in fashion design, and I was a clothing manufacturer, and we had 500 open doors in the United States and in Canada, and I was hoping to expand, but unfortunately 2008 hit and they hit it hard and fast and I lost most of my managing capital in the year that I think was my tipping point. So it was the, the year that I finally got a lot of traction and had a lot of repeat business and a lot of new business as well. And a lot of those new businesses just refused orders. Just from the east coast to the west, and it was just tons of money out that wasn't gonna come in. So there was really no way to, make that work after that, like I lost literally all the money I had in my business in like the span of, I would say three, four weeks. It was just mortifyingly scary. But I was young and people who are young are resilient and they move on and they find a new dream. And it took me a minute, like I didn't really know what the french toast I was gonna do. And I was like, well, I was still planning on staying in fashion and long, short, I was offered a job to do and run production for a one, a different company. So make sure that their goods were produced on time. Deal with the, the timing of all the orders, making sure the product line. So it was basically operations for manufacturing. And I was super excited about the job and I moved back to my parents' house at the time because things were just that tight financially for me. My parents were like, "Yeah, just, you know, come back, we'll figure it out." And I remember saying to my mom and dad, I'm like, "If this job falls through, do you mind if I just go back to school and stay here?" And they both started to laugh at me like, "Your job is fine, but if the sure why, why not?" And they, they thought it was crazy. And then I ended up back in school. So, they were like, "Whoa, that was really insane," 'cause that was in the end of 2008, starting 2009. And so the company rescinded their offer and they were really like, so sad about it, but they went to a market to sell their clothes and they got zero orders that year or something like close to that. So it was just, it was just a really intense time in the fashion industry and I was looking for jobs and I wasn't getting anywhere. So I only had an AA, and at the time that really didn't matter, but I went back to school and I'm like, "If I'm going back to school this late in age, I'm getting a master's degree." I had no idea what I was gonna get a master's degree in. I was like. I like clothes and design. We'll figure it out from there like that. And I was like, "Well, maybe I'll be..." this is crazy. But I was thinking about being a lawyer, like a property law lawyer. So, because when you are a designer in clothing, people can just knock you off. And you've seen that happen like pretty much everywhere. And people can just take advantage of your intellectual property and never pay you for it if they change enough of it. And so I was like, "You know, this would be something I'd probably be good at." So I went back to school thinking I was gonna go into that type of law. I took psychology courses and I took philosophy courses. And philosophy courses really do lean you, get you thinking very specifically about law. That's what philosophy was basically geared towards anyways. And you take these psychology courses and they're about people and how people process information, how people behave based on their behavior and things like that. So I thought the combination would be really good. Well, I ended up not liking, I did like philosophy, but philosophy's "let's think about thinking about it." And psychology is-- which is great. It's great, but psychology is like more applicable when you're interacting with others. And I found it super fascinating. And then I got really into like cognitive psychology and I'm like, "What the french toast am I gonna do with this? I can't do anything with cognitive psychology. Like I need to make money. I'm a grownup. This isn't ah, I'm gonna study underwater basket weaving and come out and go work in communications at Fox." Like I had to have an actual plan. So in my college at the time, there were these classes and they were like introductory to what you can do with your degrees. And that's literally where I found human factors. And there weren't very many schools that did it, but I was taking most of my classes at that point in cognitive psychology, which is how people process information, not their feeling based stuff. Like I didn't wanna have conversations with people about their feelings. Get that off of me. Like that's not, that's not my jam. I'm like, "Sorry, you're sad, but I'm not sad and I don't wanna be sad, so I'm gonna keep, keep going." And I'm like, "How am I gonna work this into my, you know, I love design, I wanna keep that in my background, and how am I gonna, what am I gonna do?" And so the study of human factors really is the intersection of design and research, and how people interact with said products based on the design. And you get to research that. And I'm like, "Sold. Good. I'm, I can do this. This is like this, I didn't even know this thing existed." This is crazy good. And I never looked back. [00:11:49] Lindsey Dinneen: Yeah. [00:11:50] Staci Miller: I got into a master's program the next year. I, and because I was in that specific program in San Jose State, that's why it was so easy for me to work for Samsung because it was in my backyard. And that's why it was easy for me to work for Interface Analysis because Tony was the owner of that company. Tony, he was my professor. So he just was like hiring people and I, I answered his response and I was like, "Hey, I, I'm looking for something." Do you like, he didn't say it was his company. He said, "I have a friend looking" and I'm, you know, like when I know I need to make some money, I'm gonna try to hustle up and make some money. So I'm like, "Hey, I'm open to that." He's like, "Why don't you come by my office and we'll talk?" And I was like, "That's weird." He said It was for some other, I'm like, "Sure, no problem." So I go to his office and he offered me an internship right then and there 'cause it was for me. "I just wanted to see who would respond," 'cause you are the only person that responded. I'm like, "Guess you're gonna hire me then." [00:12:37] Lindsey Dinneen: Amazing. All right. That's great. Thank you so much for that background. And it is so interesting how sometimes our paths are very, very windy to get to where we end up being and we Yeah, exactly. What, what ends up being a really good fit. But, so can you explain a little bit more about human factors, especially, maybe to help folks who have maybe some misconceptions or don't fully understand what it is just in general, but then also relate it specifically to medtech and why it's so important within the medtech industry? [00:13:11] Staci Miller: I can give you a story that probably would do both. So human factors was, was actually founded pretty recently in our timeline of psychology and understanding people. In World War II, there were a whole bunch of fighter pilots ejecting themselves from planes that caused, even in World War II, millions of dollars to produce and nobody could figure out what the problem was. They checked the planes. The planes were operating correctly. They did psychology, like psychological backgrounds on the people who are fighter pilots. I mean, they have to, to get into the military and to fly those planes, you have to be pretty good under pressure. They interviewed them, they were fine. They didn't have any breakdown of stress, and it wasn't happening on a small scale. This was happening on quite a large scale. So they, again, they went, they're like, "Okay, okay." Well, the military went back and " Well, it has to be the plane." So they looked through the plane, wasn't the plane, talk to the people, wasn't the people. So then the psychologist started to ask questions. They're like, "Well, if you're saying that it's not the person's emotional state and you're saying it's not the plane, well then what happened? Something had to happen. Something changed. What changed?" It turned out that the engineers had moved the throttle button with the ejection button in the planes. [00:14:31] Lindsey Dinneen: Oh. [00:14:31] Staci Miller: So the pilots were originally trained to hit the throttle button on the certain side that the throttle button was in the cockpit. So instead of hitting the throttle, because that was their original training, they hit the ejection button. So they ejected themselves out of the planes, which is why human factors was born. Those little changes that people don't understand about human beings. So when we learn something for the first time, because like even if you think about being a kid or being a baby, or learning a really tough lesson, right? You remember that lesson. And so what happens is that's your default setting. "This is the lesson I've learned. This is how I react." Now for that lesson, it doesn't matter if it's like an emotional exchange or if it's a physical one. So because they were taught where the, the pilots were taught specifically where the throttle was in the first place when they were under attack and they were in a high cognitive loaded space, they went back to their original training. [00:15:30] Lindsey Dinneen: Mm-hmm. [00:15:32] Staci Miller: And then the engineers were like, "Well, we told them. We told them." So, so, because they didn't wanna take the blame, right? Nobody wanted to take the blame ruining millions of dollars of planes. So this same type of thing happens in the medical industry. I mean, you can see it pretty easily, right? So you're trained on System X. There's an update, a 510K release to it. The system works differently. Errors are made, people are hurt. [00:15:57] Lindsey Dinneen: Mm-hmm. [00:15:58] Staci Miller: That's how it translates to medical. So aviation was a really big part of human factors and it still is to this day. Like NASA used to hire quite a few of my classmates. And I know that Boeing and a lot of those other, even BMW hire people that do what I do for a living and test the responses during drive time. And if you think about it, if you look at a Tesla versus a BMW, those are very different driving experiences. Like I had to relearn how to drive a Tesla, right? And like it has a one pedal situation. So now when I get into regular cars, I'm like, "Wait, what? What am I doing? What? What kind of car is this? Like how do I drive this thing again?" I know that sounds silly, but it, it's true 'cause you kind of just get used to the thing that you have. And that's exactly why human factors is prevalent in medical device or in aviation or in, you know, like any kind of like navigation systems. The reason the FDA mandated it is because a lot of products were coming to market and there was a very large influx of critical catastrophic errors in hospitals. People were suffering consequences of bad interfaces or lack of instructions on products. I know that there were a lot of intravenous medications given that weren't supposed to be IV medications in like in certain-- yes, you're supposed to inject it, but not. Intravenously and those charged caused people to perish. So that's when the FDA stepped in and said, "Okay, we were asking you as a favor to do these usability studies, but now officially they're part of your risk requirements and they're part of your requirements to get to market." And I think that happened about the time I graduated grad school, around that time. So about 15, 16 years ago. [00:17:50] Lindsey Dinneen: Okay. Yeah. Well that's a fascinating story, and I'm sorry that that is the impetus for the results that we have today, but also how incredible that that is something that's being prioritized and mandated now. And I'm wondering too, when a startup company is developing their technology, how soon should they be thinking about human factors, usability, UX/UI. [00:18:17] Staci Miller: As fast as they're thinking about risk. if you're already thinking about risk at phase zero, that's when you should be thinking about usability and UI and interactions based on user processes, because that's when this kind of conversation really needs to start with regulatory, with your team, with the engineers. So even if you don't have a human factors engineer on staff, like you can find a company that can give you like some fractional support, just, you know, to talk to and to understand what their, what, what their responsibilities are, and what their requirements are to get to market. I have found that a lot of founders don't think that it's a requirement. And I, and I'm really not sure why, but that's been happening a lot lately. [00:18:59] Lindsey Dinneen: Yeah. So because it's a requirement, because you should be thinking about it from the get go, what are some things that you've seen work really well in terms of, putting together this kind of this testing and whatnot versus things that might seem like they could work. Like perhaps somebody feels that they could maybe do some of this testing themselves. You know, just, just things that maybe people who aren't really familiar with all the regulations would perhaps do, and that could cause problems down the road. [00:19:32] Staci Miller: So there's a, these are all really great questions and let's, let's unpack the idea of research, right? So some people think that research is finding out if somebody is happy about a product and would use it, like product market fit, right? Some people do marketing for that, and I can, that's the type of research that is not technically human factors, but it is something that Gen UX can do, right? So it's just research. I, I call it like insert white meat or insert protein. We can do the research, right? So when it comes down to it, there's, I would say that research is split into two buckets, which is UX/UI, which is very popular and people understand that, which is a formative in the FDA guidance and then validation slash summative. So the validation studies are very clean cut. So I'll explain those first. And they are to validate that the user can use the system in its environments safely. So the alpha for that is the user is successful at using this product and the uses, uses and use environments correctly and safely. And this is all based on your risk documentation from your URRA or your UFMEA. Some people use ADFMEA, which is based on design, and I suggest that they don't use that because that focuses more on the system than it does on the user. And the FDA has really cracked down on that. So if you are a founder and you think you can get just one system, ADFMEA, you are probably already starting off on the wrong foot. Make sure you have your own usability. Because human factors work really focuses on two things in the medical industry. One, it focuses on helping develop the device while breaking down risks. So if you have mitigations and your system's designed a certain way to avoid a risk, that's very important, and that's really also usability testing. And I can explain this in two ways. I've worked at Meta, I've worked at Samsung, I've worked at a lot of different big tech companies, and I've worked at a lot of medtech companies. So I think that people think that human factors is different than user research, and they're right. Human factors is much harder than user research. And you really actually need a background in research methods and an understanding of how the application of research works. Formatives can be used for two reasons. One, to support the need of the product in use and to check how people are actually using the system in real life. So sometimes people are really good at thinking-- so engineers are amazing at building systems, right? I can't do what they can do. I'm not gonna pretend like I can. What I can do is help them build it for their end user, because a lot of the times engineers think very differently than the average human being. They're much more educated. Schooling for engineering is extremely difficult. A lot of it's mathematical computations, understanding actual physical properties of things in their environments and how that they work, right? So those are the things that engineers think about all day long. That's fine. I think about the user all day long. So you can create a system that an engineer thinks that is fine, but then the user is " I don't really know how to use this. What are you talking about?" Right? And so that's what user research informatives avoid. They avoid, they break down risk and they are able to help form the product. So those, those user research studies, like before, let's say phase zero to phase four in a market cycle, if phase five is market release, are for those things. And then as you get later in the cycle, you wanna do more rigid research, that's really breaking down the risk and really focusing on the user interactions within the system and med device. And making sure that they're assessing the risk based on your user, but they're very specific to the user interactions that are critical tasks and higher. Or things that lead up to the critical test and come away. So like you have to be able to do the steps before, do the thing that's really hard to do, that could hurt somebody and then make sure coming away from them you don't cause any harm either. That's the best way to look at these types of tests. And we do the exact same thing in validation for systems. So, in software you test to see if the software can do the thing that it's supposed to do. When you check that box, the software does the thing and it did it, and we're good to go. You do the same thing with mechanical engineering. The system has this, this range of motion here and this range of motion here, and it doesn't deviate from plus X to plus Y and therefore the system does what it's supposed to say. So you're verifying and validating that the system does what the system is planned to do. It's really no different in users, it's just that you're dealing with human beings and it's not, it doesn't work the same way, right? Because like people are variables no matter what. And that was really long worded. So there's like tons of different research to do, but if you don't do your summative and you don't do your risk documentation, you're not getting to, you're not gonna get to market approval. Just, there's no way. [00:24:34] Lindsey Dinneen: Yeah. Thank you. Yeah, that is incredibly helpful insight. And you know, so I wanna go back to, you had this company before, right? So you had already built a business and it was thriving, and then unfortunately life intervened a little bit. When you went to start Gen UX, did you have moments... [00:24:57] Staci Miller: Of PTSD? [00:24:58] Lindsey Dinneen: Of, yeah. [00:25:01] Staci Miller: Yes. [00:25:01] Lindsey Dinneen: Yeah. [00:25:02] Staci Miller: Yeah. I had major PTSD. Like I, so the concept of Gen UX was a play on words like, so I'm a Gen Xer, no biggie, but like I think that every Gen Xers, millennials, I feel like both of our generations very much identify with our generation. And I thought it would be kind of a fun play on words to identify to people that are also Gen Xers that, yeah, we do UX work and we're Gen UX, as a Generation X, like it was very important, right? So I kind of came up with that idea, thought it was cute. But at the time I was working for Meta, and Meta had been doing quite a bit of layoffs at the time. Nothing wrong with that, that happens with every company. But I have survived in Medtronic and Abbott and all these other companies. I had survived so many rounds of layoffs. I'm like, "One day my number is gonna be, it's just, it's just gonna happen." So, we started at Meta internally, really like they, they were very open and honest with people. They're like, "This is when this is gonna happen. We are gonna lay off more people. This is when this round is gonna happen. We're gonna lay off more people, and then this is the final round and this is when we're gonna lay off these people." So each of our groups of things like, so it was like engineers, lawyers, researchers. Like we, we had timelines that we knew if, if it was gonna happen, this is when it was gonna happen, this would be the day. [00:26:17] Lindsey Dinneen: Yeah. [00:26:17] Staci Miller: So I started to really think about what that meant, and I'm like, "Okay, well I'm not gonna start looking for jobs right away because I want my severance package." I definitely wanted that 'cause I, and then I wanted a break if I could have it. So I was like, okay. I, in between working at I was working at EDA as a contractor and that was super fun. Like I had my own time kind of, and I enjoyed the work and I got put on other projects whenever they needed me. And it was like, but I was constantly on a project, so I'm like, "I, maybe I'll go into doing IC work by myself" and I'm like, "No, I can't make enough. If I'm gonna do this, I'm gonna build something." And then I'm like, well, I started to talk to my friends every single one of my friends, including Interface Analysis' owner, Tony Andre was like, "Start your own business, Staci. Start your own consulting firm, just do it. Don't even look back. Just do it. People will end up coming to you because you know how to do this." He's like, he's it's, "You know, the first years they are what they are and everybody knows what that looks like. It's, it's rough. You have, it's like a mental game. You're like, I am gonna do this. And you just have to be consistent and can continue down your path. And more and more people will show up." And that's been true every year. But that's how GenX was started. And yes, there was this whole trepidation about, "Am I gonna make it? Am I gonna make it through this?" And I was like, "You know what, Stac, you're starting in a recession in your, in your industry. If you can get it done, if you can get two years in and be successful, you're fine." I'm in year three. [00:27:50] Lindsey Dinneen: Yeah! [00:27:51] Staci Miller: Yeah, I mean, year three, woohoo. And we're increasing 50% year over year in year three, and I started it with $0. So, and I'm not, I'm not saying like a hundred to 50, like $50 to a hundred, we're, we're talking a couple hundred thousand dollars here, a couple hundred thousand there. But it's modest and I do expect that growth, and I do expect that to continue. And the other thing I think about is becoming very malleable in, in your spaces, like what's working for you and what doesn't work for you. But I feel like that's kind of off topic from what you asked. But yeah, I had PTSD gave myself at least two years and I'm like, "I can do anything for two years. If it doesn't work out, you know, like I have everything that I have and I can go back into corporate if I need to." And I really, I really was tripping, like just to be nineties about it, I was tripping. Like I was really like, "You know, I don't know." And my husband was like. He was my biggest cheerleader. He was like, "You've gotta do this. He's you're gonna, you're gonna be able to do this. You have something that I don't have. You're really great at networking people like you." I'm like, "Do they really like what?" And he's, " No, people like being around you. You make friends easy and people really do enjoy being around you and they like know that you're smart and you're gonna be able to do this." So, that's how this all started. And yes, I was really freaked out when I first started, but every day when I had bad days, I'm like, "Everything always works itself out." [00:29:14] Lindsey Dinneen: Yeah. [00:29:14] Staci Miller: "Have you ever not been in a situation where everything works itself out?" "No. No." So I'm like, "Well, if I, if it doesn't, I'll get a new dream, but I don't-- once you hit this, this year, like year three and you know you're still growing, you don't have to get a new dream, you just keep going and you're like, this dream is happening. I'm gonna keep it going." [00:29:34] Lindsey Dinneen: Yeah. What was it like building a team? Did you start off as a one-woman show, or did you have support at the beginning? How did that work? [00:29:43] Staci Miller: So at first, actually my designer's father was working with me and he called me out of the blue and he's " Hey. I have this client, she doesn't have any human factors person working with her, but I know that she needs it and do you wanna talk to her? I know you're not working at Meta," because I put on my, oh. LinkedIn profile Open to Work. So he called me like within two days, like seriously, like people started to call me and that was when I was already like, "I'm gonna do my own thing. I'm just gonna do my own thing." So the universe just brought me a gift, right? And I met this first client and I started to work with her, and at first everything was super cool. The first year it was great, and I really liked working with her, but she also needed a couple of other things. She needed an IFU and she needed design quality assurance. I'm like, "Check, check. I can get both those things done." So I called my friend Maria, "Hey, do you wanna work with me? She's " Hey. Yeah, totally." Because we had already worked together and we knew each other pretty well. So it wasn't like it was difficult to make that connection. And, and she knows my personality. I know her personality, and I know we both work extremely hard and we have that in common. So I wasn't, never, would I be worried about Maria. And then I found I wasn't, I didn't even have a designer yet on staff. And I found someone who used to do instructions for use for a different company I worked for. I called him like, "Hey, can you do this?" He's " Yeah, yeah." So I got all that done for this other client. I'm like, "I can do this. I can do this. I can, I can find people." I know so many intelligent people who love what they do and have a fire for it every day. And then the evolution started to happen. And then I asked someone to work with me to do sales, and then they said, "Yes." And then we started to pitch people that I was friends with and knew, and sometimes they said yes, and sometimes they said no. I think the first year, I think I pitched over like $4 million in business and I got 20,000. No, I got, I got 80,000, something like that. Something, something small and I'm like, "Why am I pitching so much? This is like taking so much time outta my day," that I found someone to work with me. His name was Adam and I still actually work with Adam and he, but he's a big picture guy and he started to work with me a little bit and help me like navigate through some things. Even to this day, we talk and he's not fully, fully, fully on onboarded, but if, if some. Of the clients that he lands do come on board, he will be back on board and he will be working with me again. And then I had a salesperson this last year and I realized just I needed more of a hunter-gatherer. So like we're just going in a different direction, right? So I had that, and then last year my goal was to bring my designer Maddie on full-time. And I was able to do that too. So everything that I've kind of just said, "I'm gonna do this this year, I've been able to do this year." And I'm not taking this lightly. Like I have a board of directors, which are people who are, have different perspectives on finance because that's my weakest link, I would say. A professor at UCLA, his name's Sean Pat, also a good friend of mine. He's on my board. And my brother-in-law and my nephew, who is new in his life and on his journey, is on my board as well, and I kind of wanted him on my board so he can see what it looks like to be an entrepreneur and see what growth looks like year over year because he is already working for companies. He's, he's like 25, I think, and he's already being groomed to be in upper management. He's got upper management written all over him as like the, as like people would say in like cute little circles. And then my my brother-in-law, he is one of the CFOs at Mayo Clinic, so these are people who have some in medical, some in finance, some in finance, in medical, just helping me like grow. I throw things past them and they help, you know, make decisions for the year. And they tell me like, they give me feedback and, and work through things that I'm doing and what they think is right, what they don't think is right. And sometimes I listen, sometimes I don't. You know, like... [00:33:28] Lindsey Dinneen: Well, yeah. [00:33:29] Staci Miller: Just really depends like where I'm at and what I wanna do and where we wanna grow. [00:33:34] Lindsey Dinneen: Yeah. Excellent. Okay. So I'm curious, especially within medtech specifically, are there moments that really stand out to you as just affirming, "Oh my goodness, I am in the right place at the right time." [00:33:49] Staci Miller: Things keep happening, so, every time I speak, like I, I spoke at Project Medtech, people bombarded me. They're like, "We wanna work with you. We wanna work with you. We should talk, we should talk." Anytime I go to a symposium I walk away with two or three leads. People coming up to me, "Oh, do you do this thing? We should really talk. We should really talk." So, just being in the situation like that kind of tells me that I'm in the right direction. And the other thing is we're growing year over year. If you take a 10,000 foot view of where I was year one versus year three now, very, very different. Extremely different. And like I said, I do have, I do have other consultants that work with me. I don't want you to think it's just like a two person shop. It's not, there's other consultants that work with me but they're as needed. They're not full employees, which I think is really helpful in a situation like this. If you're a founder starting up from scratch and you're not, you don't have, I'm not trying to get angel investors. I'm not trying to get people to push money into my company. I am building it literally from zero to whatever it is that I make. And so that, that's a, what I would call like a slow burn of, you have to build your foundation, you have to manage to the capital that you do have, and then you, then you go to the next level and you do the same thing and then you do the same thing. And there's a lot of consistency with the business now, and I see a lot of people targeting me for that consistency. And as, as we are growing, like people are engaging with us on a different level, which is exciting to see. That's always exciting. [00:35:20] Lindsey Dinneen: Yes. [00:35:20] Staci Miller: That's kind of how I know. Yeah. [00:35:23] Lindsey Dinneen: I love that. Awesome. Okay, so pivoting the conversation a little bit just for fun. [00:35:28] Staci Miller: Cool. [00:35:30] Lindsey Dinneen: Imagine that you were to be offered a million dollars to teach a masterclass on anything you want. Could be within your industry, but it doesn't have to be. What would you choose to teach? [00:35:40] Staci Miller: That's a great question. I love, I think it's very important when you do what you do for a living to have something that isn't that for yourself. So I, there's very specific ways as to how I unwind at the end of the day. One of those things is cooking. I would totally do a masterclass in being a home chef. Like I'm, I'm not even a chef like that. I've never gone to culinary school, but I absolutely, I make my own breads. I make chutney sometimes when, when I want some. I would do a masterclass on-- I'm not Gordon Ramsey. I'm not Thomas Keller. Here's what it looks like to be a home cook. And here's the, the five things that you actually need. And this is what you should learn how to make first. Like I remember the first time I was trying to make pasta or something, I boiled the water to death. There was no water left in the pond. Like I didn't even know what I was doing. I, maybe I walked away from it, I don't know, but I destroyed the pot. My mom's " What were you doing?" I was like, "Making pasta." And she's " What, what, what happened? You ruined the pot." I'm like, "I'm not, I just did it wrong." So I would probably do a masterclass in how to just take that first step learning how to make your own food, right? And talk about food 'cause I like food. There you go. That's what I would do. [00:36:52] Lindsey Dinneen: Love it. I love food and I love talking about it. So, that sounds like a great class. [00:36:58] Staci Miller: I would do, I would totally do it. [00:36:59] Lindsey Dinneen: Okay, and then how do you wish to be remembered after you leave this world? [00:37:07] Staci Miller: This might be dating me, but Roy Orbison who wrote the song, "Pretty Woman" that was also in the movie, "Pretty Woman" wrote that he "just wanted to be remembered." And I thought that was really interesting. And I think that everybody knows that song knows that it's the guy like, I don't know if you know like the artist, but I think even to this day, that song, generationally, people know that song. I don't know how I wanna be remembered, but this is how I wanna impact the world. So it's kind of like that, but kind of not. I believe that knowledge transfer is the most powerful thing that we have amongst generations. And I want the next generation to be better than me, which is probably, in my opinion, I'm kind of kind of strict about this, probably a tall order, 'cause I'm like very picky. But, I have mentored and, and taught people my craft, and I want them to be better than me so they can mentor people and be better at this craft. So if I leave one mark on this world, it's that I have taught somebody what I know how to do and I expect them to do it better than me. And I don't mentor just anybody. So if I'm mentoring you is, and I'm putting all this energy into you, you better, you better bring it. And the people that I have worked with and have mentored are doing extremely well in their careers, and that's, that's kind of a thing that I like about, like what we do and how I do it. So I don't know if I would be specifically remembered for that, but I do know that it would move our industry forward and that makes me happy. [00:38:39] Lindsey Dinneen: I love that. That's a beautiful legacy. All right, and then final question. What is one I know, what is one thing that makes you smile every time you see or think about it? [00:38:52] Staci Miller: When I see what I'm building or, or how I'm building it in the future and I really go deep within my, my consciousness about this is what I'm gonna do next. This is how I'm gonna do it. This is what makes me feel really alive. I get so excited. I get like goosebumps. I start smiling. I, I'm a big-- I don't know if you do this, Lindsey, but I do this-- I kind of dance around a little bit. Like I dance when I'm making food, I dance and most people dunno that about me. But I, but my closest friends I remember I was working with this one guy and he looks at me, he's " Do you ever stop dancing?" I'm like, "Nope. Nope, Nope. Gotta dance." So all that stuff like starts to happen. And I just get really excited about the things that I'm trying to build, what I'm trying to master in my own world, what I'm trying to create. And that's what gives me like so much excitement. And then a number two would be my cats, because they're ridiculous and I love them and they give me so much love and they make me smile all the time too. [00:39:52] Lindsey Dinneen: Oh yes, those are great answers. I love that so much. It is exciting to see. Dreams come true. I can totally understand that answer of getting the, the excitement, the tingles, and then yeah, I, yeah, I, I obviously relate to dancing around all the time, and especially like celebratory dances. They're, my celebratory dances are the goofiest, most ridiculous things you've ever seen, but I'm happy! So. [00:40:20] Staci Miller: As long as you're happy, that's all that really matters, right? Like that vibe that you're putting out there and the happiness and the giddiness, like the things that I'm building in my mind, like they haven't happened yet, but I'm dancing like they have, you know, because I hope that they do. Like there you go. And I think that's important. I love it. [00:40:35] Lindsey Dinneen: True embodiment of the vision. I love it. Well, well, Staci, this has been a great conversation. Thank you so much for your insights and your stories, and we are so honored to be making a donation on your behalf today to Feeding America, which works to end hunger in the United States by partnering with food banks, food pantries, and local food programs to bring food to people facing hunger, and also they advocate for policies that create long term solutions to hunger. So thank you so much for choosing that charity to support. And gosh, I just wish you the most continued success as you work to change lives for a better world. [00:41:15] Staci Miller: Thank you, thank you. It was so much fun being with you today. I appreciate this and it was so much fun to talk about. And yeah, I can't wait to see you in the next couple weeks too. So we'll see each other soon. [00:41:26] Lindsey Dinneen: Yay! Sounds good. Well, thanks again and have the best rest of your day. [00:41:32] 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.

Great medtech innovations win because patients actually use them. In this episode, Ken Nelson, Partner and Founder at Nelson Jennings Ventures, shares his journey from cardiac device sales at Boston Scientific to helping commercialize major players in cardiac monitoring, including iRhythm, BioTelemetry, and Bardy Diagnostics. He highlights how innovations such as wearable cardiac patches have transformed patient adoption and reshaped the monitoring market. Ken reflects on Medtech Innovator's impact in accelerating commercialization, partnerships, and investor readiness. He advises early-stage companies to leverage accelerators and industry events like Life Science Intelligence to strengthen their path to market and fundraising success. Tune in to hear how decades of experience in cardiac monitoring and startup scaling translate into practical advice for founders navigating commercialization and growth! Resources: Connect with and follow Ken Nelson on LinkedIn.

Are you expanding your MedTech business internationally too fast without realizing the operational risks you're creating?Many clinicians assume international growth means entering as many markets as possible as quickly as possible. But in reality, aggressive expansion often destroys operational focus, stretches infrastructure too thin, and exposes weaknesses inside the business. In this episode, Hakeem breaks down why controlled scaling beats reckless expansion and how smart MedTech companies use strategic market entry to reduce risk instead of increasing it.Listeners will discover:Why entering multiple international markets at once can quietly damage business growthHow strong domestic execution creates a competitive advantage when exporting internationallyThe difference between scaling strategically versus scaling emotionally through excitement and FOMOPlay this episode now to learn how to expand your MedTech business internationally without losing operational control, focus, or profitability.Source transcript:Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.

TEATIME WITH MISS LIZ SERVES: Lindsey Dinneen Title From Vision to Impact: Transforming Ideas into Action in a Changing World Tagline When purpose meets strategy, ideas don't just stay ideas—they change lives. Description On May 28th at 3 PM EST, Teatime with Miss Liz welcomes Lindsey Dinneen—Director of Marketing & Engagement at Project Medtech, business consultant, and global digital nomad. With a background spanning business strategy, marketing, and leadership, Lindsey has built and scaled ventures from the ground up—including a dance studio and nonprofit organization—often with little to no budget. Her ability to turn vision into action has become her signature strength. Now rooted in the medtech industry, she works alongside mission-driven teams to bring life-changing innovations to patients around the world. Her T-E-A: Transforming Energy into Action reflects her belief that ideas only matter when they move. This Teatime is about purpose, innovation, and turning passion into real-world impact. Opening Introduction Welcome, everyone, to Teatime with Miss Liz—where ideas are not just shared… they are brought to life. Today, we sit with someone who understands that vision alone is not enough—it's what you do with it that matters.Lindsey Dinneen is a catalyst—someone who takes energy, ideas, and purpose, and turns them into action that creates real impact. From building businesses from the ground up… to working in an industry that directly impacts lives… her journey reminds us that creativity, strategy, and heart can come together to do something meaningful. Because ideas don't change the world—people who act on them do. Lindsey, welcome to Teatime. Closing Summary What an inspiring and forward-thinking conversation. Lindsey Dinneen reminds us that purpose is not just something we feel—it's something we act on. Her journey shows us that even with limited resources, creativity and determination can create powerful results. It's not about having everything—it's about using what you have with intention. So today, we leave with this: What idea have you been holding onto that's ready to be put into action? Because the world doesn't need more ideas—it needs more people willing to bring them to life. Now we open the floor to you—your thoughts, your voice, your reflections. Lindsey Dinneen is Director of Marketing & Engagement at Project Medtech, a business consultant, and marketing strategist. She specializes in building and scaling mission-driven ventures, often with limited resources. Passionate about innovation, she helps bring impactful solutions to life, particularly in the medtech industry, improving outcomes for patients worldwide.#TeatimeWithMissLiz#WomenInLeadership#MedtechInnovation#PurposeDriven#TakeAction

Why do so many MedTech innovations fail to gain traction—even when the technology works exactly as designed? In this episode of Med Tech Gurus, we're joined by Erin Rollenhagen, Founder and CEO of People-Friendly Tech, UX strategist, and author of Love at First Launch. With experience leading over 200 successful technology launches across healthcare and other regulated industries, Erin brings a unique perspective on what truly drives product adoption. Erin explains why usability and emotional connection often matter more than features alone—and why success depends on how both clinicians and patients feel when interacting with new technology. We explore how companies can preserve the original vision behind their innovations while navigating compliance, scaling challenges, and evolving market demands. From designing onboarding experiences that build trust to using AI thoughtfully without overwhelming users, Erin shares how MedTech leaders can create solutions that align with real-world workflows and deliver meaningful outcomes. If you're a founder, executive, or investor looking to improve clinical adoption and scale innovation without losing the magic of your original idea, this episode offers practical insights into building technology people actually want to use.

Part 2 with Joe DeVivo, the MedTech CEO who sold InTouch to Teladoc for over $1B and promised himself never to do another turnaround. Two years later, the board of Butterfly Network called w/12mo cash left. Here's how he did it.

Most medtech startups fail before market. The ones that succeed? They plan for it from day one. In this episode, Amanda Helgeson, Business Development Manager at Forj Medical, discusses her work at the CDMO, which helps medtech startups navigate the critical transition from development to manufacturing. She notes that standout companies at Medtech Innovator pair meaningful clinical innovation with the passion and persistence needed to reach the market. Forj differentiates itself by integrating design and manufacturing early, helping companies avoid costly downstream issues. Her core message is to take a holistic, long-term approach, aligning product design, regulatory pathways, and reimbursement strategies from the outset while staying flexible to adapt. Tune in to learn how a holistic, future-focused approach can turn promising ideas into scalable medical devices! Resources: Connect with and follow Amanda Helgeson on LinkedIn. Follow Forj Medical on LinkedIn and explore their website!

Are hidden operational mistakes putting your MedTech export strategy at risk before you even enter a new market?Exporting a MedTech business internationally is far more complex than simply finding distributors or translating documents. In this episode, Joshua Gould explains the operational, compliance, AI, and scaling mistakes that cause companies to lose momentum when entering global markets — and what leaders need to do differently to scale successfully.Listen to discover:The operational mistakes that cause international expansion to break downHow AI can become a real commercial advantage instead of just another buzzwordWhat MedTech companies must understand about compliance, infrastructure, and market-entry strategy before scaling globallyPlay this episode now to discover the costly mistakes MedTech companies make when exporting internationally — and how to scale globally without losing control of your business.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.

In this episode of Medsider Radio, we sat down with Dr. Connie Lehman, founder and CEO of Clairity.Clairity is the first FDA-authorized AI platform that predicts a woman's five-year risk of developing breast cancer using only a routine screening mammogram.A physician scientist with over 300 peer-reviewed publications, Connie is a Professor of Radiology at Harvard Medical School and Breast Imaging Specialist at Massachusetts General Brigham (on leave). She holds an MD and PhD from Yale and was named to Forbes' 50 Over 50 Innovators and TIME 100 World's Most Influential Leaders in Health.In this interview, Connie discusses her experience translating academic research into a commercially viable startup, the massive undertaking of generating clinical evidence when you're creating a new category, and how Clairity is approaching adoption on two fronts: fitting into physician workflows and building access pathways for patients.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 Connie Lehman, which includes a link to ScottBot — an AI version of host Scott Nelson trained on every Medsider interview and playbook. Feel free to ask ScottBot any questions you'd like!KEY MOMENTS FROM THE INTERVIEW(03:04) - The broken screening paradigm Connie saw in clinic — and the gap that became Clairity (05:09) - How Clairity rolls the clock back from detection to predicting risk in healthy women (07:31) - Why "more data is better" turned out to be wrong and how that shaped Clairity's product scope (21:57) - How physicians can translate grant-generating discipline into building a company (24:56) - What 18 months of pre-sub meetings revealed about navigating a de novo pathway (26:49) - Why Clairity validated its technology in over 250,000 mammograms when FDA required far less (34:43) - How Connie flipped the natural question from "how can doctors offer this?" to "how can women access it?" (43:47) - How relationships, not pitches, drove Clairity's $43M Series B

In this episode, pulmonologist, intensivist, and advanced bronchoscopist Huzaifah Salat joins Duane Manicini to unpack what's changing in lung cancer care, and why the biggest constraint in MedTech isn't the FDA, funding, or clinician adoption, but founders building for clinicians instead of with them. Huzaifah shares how robotic bronchoscopy, advanced imaging, and better CT quality are enabling diagnosis of tiny, moving lung nodules, and why the next wave may be non-invasive diagnostics like blood-based, saliva, or bronchial secretion testing. He offers an inside look at serving as a regional medical director and physician voice to the C-suite, where “no margin, no mission” meets patient-first priorities, and explains how diverse frontline perspectives, beyond physicians alone, shape products that truly fit real clinical workflows.Huzaifah Salat LinkedInDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law and JumpStart Inc.

Transformational medtech innovation needs more than a great idea. It needs the right engineering, clinical evidence, reimbursement strategy, and commercialization support to reach patients. In this episode, Peter Lewis, Executive Vice President of Business Development at Hydrix, joins Saul Marquez at the MedTech Innovator Radar Forum to discuss what it takes to bring complex, safety-critical medical devices to market. Peter shares Hydrix's evolution from its origins in Australia to becoming a global medical product development company supporting cardiac, surgical robotics, imaging, neurostimulation, and other advanced technologies. He highlights why clinician-led innovation is especially powerful, what distinguishes today's most promising medtech startups, and why AI, reimbursement, and human clinical evidence are now essential pillars for growth. Tune in to learn what medtech innovators need to consider early if they want to build solutions that truly change care. Resources: Connect with and follow Peter Lewis on LinkedIn or reach out via email. Explore the Hydrix website here!

Are you frustrated that your clinically sound medical devices aren't gaining traction in healthcare?In this episode, we challenge the notion that clinician agreement equates to adoption. You'll learn that adoption is a complex behavioral change that requires understanding multiple roles and barriers.By listening, you'll discover:The key barriers to adoption and how to address them effectively.The importance of tailoring your evidence story for different audiences.Actionable steps to create a behavior change plan for your medical device.Tune in now to transform your medical device strategy and enhance clinician adoption!Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.

A medical device's intended use is not just a regulatory formality — it is the foundation of the entire product strategy.In this podcast episode, Monir El Azzouzi speaks with Karandeep Badwal about how intended use influences classification, clinical evaluation, risk management, labeling, and ultimately market access.The discussion explores why many companies underestimate the importance of intended use and how poorly written statements can create major downstream regulatory problems. From Software as a Medical Device (SaMD) to AI-driven products, the episode highlights real-world examples where unclear intended use created challenges during certification and compliance activities.The episode also provides practical guidance for manufacturers on:Defining a robust intended use statementAligning intended use with clinical evidence and risk managementAvoiding “labeling tricks” that may trigger regulatory scrutinyBuilding internal collaboration between regulatory, clinical, and product teamsThis is an essential discussion for MedTech startups, QA/RA professionals, and manufacturers navigating MDR, IVDR, FDA, or global regulatory pathways.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.Linkkarandeepbadwal linkedin: https://www.linkedin.com/in/karandeepbadwal/qra-medical linkedin: https://www.linkedin.com/company/qra-medical/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 hosted by Podcastics, the easiest platform to create and publish your podcast.

Successful medtech commercialization requires founders to know what only they can do best, then bring in the right partners to help scale the rest. In this episode, Dan Purvis, Chairman and Co-Founder of Velentium Medical, joins Saul Marquez at the MedTech Innovator Radar Forum to discuss the evolution of complex medical device development. Dan explains how Velentium was designed to integrate engineering, firmware, mechanical design, cybersecurity, testing, and manufacturing under one roof to better support OEMs from development through production. He also reflects on how medtech innovation has matured, with more companies arriving at events with working technology, animal data, and clearer paths to human use. Finally, Dan emphasizes that successful commercialization requires founders to focus on their strengths, build expert teams, and delegate specialized work. Tune in and learn how medtech companies can move from promising technology to scalable, secure, and patient-impacting solutions. Resources: Follow Velentium Medical on LinkedIn and visit their website here. Connect with Dan Purvis on LinkedIn.

Are you frustrated that clinically approved medical devices aren't gaining traction in healthcare?This episode dives deep into the gap between evidence and execution, revealing that it's often not the product, but the behavioral changes required for adoption that are overlooked. We challenge the common assumption that education alone will drive change.By listening, you'll discover:The key barriers to the adoption of medical devices in healthcare.How to approach behavior change for successful implementation.Strategies for improving clinician engagement.Tune in to discover how to turn your medical device into a success story in the healthcare market.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.

On this episode of the Medical Alley Podcast, host Ben Wagner sits down with the leaders of Mobius Medical — co-founder Stefan Czyniewski and VP of clinical operations David Pomfret — for a behind-the-scenes look at the regulatory and clinical strategies shaping the future of medtech innovation. From early feasibility studies in Australia, to scaling operating in the United States, the conversation explores the realities of clinical research, the biggest mistakes founders make when building regulatory strategies, and why bringing medical technology to market is "not just hard — it's really, really, hard." Send us a message! Follow Medical Alley on social media on LinkedIn, Facebook, X and Instagram. 

Most medtech startups don't fail because of bad technology; they fail because no one built the market for it. In this episode, Ken Nelson, Partner and Founder at Nelson Jennings Ventures, and Omar Khateeb, CEO of MarketCraft, share how judging at MedTech Innovator sharpens their perspectives as investors, operators, and mentors by exposing them to diverse expert insights across regulatory, reimbursement, and commercialization. They emphasize that medtech success today requires far more than a great product; founders must actively build market demand and prioritize commercialization early. A major mistake many startups make is assuming acquisition will come easily after FDA approval without demonstrating real market pull and adoption. Ultimately, the best founders balance conviction with coachability while leveraging ecosystems like MedTech Innovator to accelerate growth and de-risk their path. If you're building, investing in, or advising medtech companies, this conversation will challenge how you think about commercialization, growth, and what actually drives valuation! Resources: Connect with and follow Ken Nelson on LinkedIn. Connect with and follow Omar Khateeb on LinkedIn. Follow MarketCraft on LinkedIn and explore their website! Check out the State of Medtech podcast!

In this episode of Medsider Radio, we sat down with Antony Odell, co-founder and CEO of Echopoint Medical.Echopoint is a London-based UCL spinout developing iKOr, an optical microcatheter for coronary diagnostics.Antony brings over 30 years of medtech experience across Johnson & Johnson, Fresenius, and Stryker, before transitioning into startups as CEO of Tayside Flow Technologies and Tissue Regenix. He holds a BSc in Physiology and Biochemistry.In this interview, Antony discusses translating academic IP into a commercial device, choosing early clinical sites to balance speed and learning, managing non-dilutive funding as a long-term discipline, and outlines the most important responsibilities of an early-stage medtech CEO.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 Antony Odell, which includes a link to ScottBot — an AI version of host Scott Nelson trained on every Medsider interview and playbook. Feel free to ask ScottBot any questions you'd like!KEY MOMENTS FROM THE INTERVIEW(03:06) - How Antony's career centered on translating clinical insights into commercial reality (05:54) - What Echopoint's iKOr does, and why 40% of cath lab patients leave without a diagnosis (12:13) - How Echopoint landed its first U.S. clinical site, and what that means for the company (13:48) - What to assess before spinning out an academic idea, and why clinician input is the first real test (20:14) - Why Echopoint chose Barts over typical sites for its first-in-human study (22:58) - How getting too close to one clinical site can lead to dangerous groupthink (30:54) - Why non-dilutive funding belongs on the board agenda permanently (39:54) - How CEOs should manage boards, control information flow, and avoid becoming a “glorified note-taker”

Are you frustrated with stagnant growth despite having an experienced distributor?This episode uncovers the common misconceptions surrounding long-term distributor relationships and highlights how reliance on these partnerships can lead to hidden underperformance. You'll learn why it's essential to reassess your distribution strategy for optimal success.By listening, you'll discover:The key criteria for selecting effective distributors in your marketHow to evaluate if your current distributor is truly the right fitActionable steps to boost underperformance and increase market growthTune in to transform your medical device strategy and unlock growth potential.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.

The future of medtech is built by the people who keep moving ideas from concept to care. In this episode, Tom Salemi, editorial leader, podcast host, and longtime medtech community builder behind DeviceTalks, shares how his path from community journalism eventually led him into healthcare reporting, medical devices, conferences, and podcasting. He reflects on discovering purpose in serving industry communities and launching DeviceTalks Weekly during the pandemic to keep conversations going when in-person events stopped. Tom also discusses the importance of continuing to move forward during career pivots and uncertain moments that require people to bet on themselves. He explains why DeviceTalks focuses on the people behind medical innovation and shares his excitement about advances in neuromodulation, stroke care, clot removal, and surgical robotics. Tune in to hear how community, persistence, and purposeful storytelling continue to move medtech forward. Resources: Connect with and follow Tom Salemi on LinkedIn. Explore the Device Talks website!

Strong medtech innovation is not just about building great technology. It is about solving a real market problem, proving product-market fit, and creating a path to sustainable growth. In this episode, Darcy Bachert, CEO at Prolucid Technologies, joins Saul Marquez at the MedTech Innovator Radar Forum to discuss how medtech companies can bring promising technologies to market. Darcy shares how Prolucid supports organizations across the medical and nuclear sectors, with a strong emphasis on imaging and diagnostics. He reflects on the strength of the MedTech Innovator ecosystem and the momentum of companies progressing through the program with impactful innovations. Darcy also explains that today's funding environment demands more than IP and regulatory progress; investors want real-world, market-ready, and monetizable solutions. Tune in and learn why medtech companies need to stay close to customers while building technologies that can truly succeed. Resources: Connect with and follow Darcy Bachert on LinkedIn. Follow Prolucid Technologies on LinkedIn and explore their website here.

Are you struggling to grow your medical device business while juggling the pressures of visibility and adoption?In this episode, we challenge common assumptions about growth strategies in healthcare. Many companies mistakenly believe that chasing patients through marketing is the fastest path to success, but this often leads to stalled growth and missed opportunities.By listening, you'll:Understand why meaningful partnerships outperform visibility in driving adoptionLearn how to assess the true value of your offering and its impact on customer retentionDiscover strategies to recalibrate your growth approach for sustainable successTune in now to uncover the secrets to building a thriving healthcare business by prioritizing value over noise.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.