Podcasts about Medtech

What if the next cyberattack didn't just steal data... but endangered someone's life?Every heartbeat monitored. Every infusion pump connected. Every medical device trusted.Now imagine what happens when those systems are compromised.In this eye-opening episode of The Raygacy Show, host Rayson Choo sits down with Christian Espinosa, a leading MedTech cybersecurity executive, to uncover the invisible threats lurking behind modern healthcare technology.This isn't a conversation about passwords and software updates. It's about the human cost of cyber vulnerabilities, the ethical responsibility of innovation, and why leadership—not technology—is the strongest defense against the next crisis.Together, they explore:

Could the wrong export distributor cost your MedTech business years of growth?Choosing an export distributor is one of the biggest commercial decisions a MedTech company will make. Yet many founders focus on impressive presentations instead of proven capability, give away exclusivity too early, or mistake a distributor for a complete go-to-market strategy. In this episode, Hakeem shares the five most common mistakes he sees and explains how to choose a distributor who becomes a genuine commercial partner.Listeners will discover:The five biggest mistakes MedTech companies make when selecting export distributorsHow to distinguish distributors with real capability from those who simply make a convincing sales pitchThe key questions every MedTech company should answer before signing a distributor agreementPlay this episode now to learn how to choose an export distributor who can accelerate adoption, support your commercial strategy, and help grow your MedTech business in international markets.If you want help with an underperforming distributor DM me on Linkedin saying "Distributor Support"This 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.

Dr. ⁠Basant Bajpai⁠ CEO of ⁠Compliance MedQRA⁠, a UAE-based consulting company specializing in Quality Assurance, Regulatory Affairs, AI governance and compliance for medical devices, SaMD, AI/ML health technologies and digital health solutions. He holds a PhD in Neuroscience focused on brain monitoring and neurotechnology and has more than 12 years of international experience supporting MedTech and digital health companies across Europe, the Middle East and the United States.He explains why regulatory and quality is still one of the most misunderstood functions in MedTech and why so many innovators treat it as a documentation exercise until it becomes an expensive problem at the worst possible moment. We get into the question every founder asks, how long will this take and what will it cost and why there is genuinely no straight answer without first building a proper regulatory strategy.We also tackle the growing trend of companies choosing the US over EU MDR simply because it looks faster. Basant makes the case that regulatory approval alone does not guarantee commercial entry, why reimbursement codes should shape your market choice more than approval timelines and why he now finds EU MDR more convenient than many people expect. He also shares a contrarian view on device classification and why staying in the lowest risk class is not always the smart play.Finally, we explore the GCC regulatory landscape, which Basant argues is not less regulated but differently regulated, with data compliance requirements he found tougher than GDPR or HIPAA. He closes with a clear message on AI in healthcare and why he does not believe regulators will ever allow a clinician to be replaced.Timestamps[00:01:23] From Biomedical Engineering to a First Audit That Changed Everything[00:03:33] Why Everyone Thinks Regulatory Is Just a Documentation Department[00:06:07] How Long Will It Take and What Will It Cost: The Impossible Question[00:09:35] EU MDR vs FDA: Why Reimbursement Should Drive the Decision[00:12:19] Regulatory Approval Does Not Guarantee Commercial Success[00:14:36] Why Staying in the Lowest Risk Class Can Backfire[00:16:00] The GCC: Not Less Regulated, Just Differently Regulated[00:18:24] Why Data Compliance in the Gulf Is Tougher Than GDPR[00:23:30] Who Should Not Pursue a Career in Quality and Regulatory[00:29:17] Final Advice: AI Will Transform Healthcare but Not Replace CliniciansConnect with Basant - https://www.linkedin.com/in/basant-bajpai-phd-63565961Learn more about Complaince MedQRA - https://www.compliancemedqra.net/Get in touch with Karandeep Badwal - ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.linkedin.com/in/karandeepbadwal/ ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Follow Karandeep on YouTube - ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.youtube.com/@KarandeepBadwal⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Medical device training courses delivered by Karandeep through Bywater - ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.bywater.co.uk/

What if the success of your MedTech product was determined months before launch?Many MedTech founders believe that strong clinical evidence and a great product are enough to drive adoption. In reality, successful launches begin long before launch day. In this episode, Hakeem shares the five biggest lessons from his conversation with Holly Miller, revealing how to prepare the market, build demand, and move your product from a "nice-to-have" to a "must-have."Listeners will discover:Why clinical evidence alone doesn't create adoptionHow to position your MedTech product as a must-have for the right audienceThe five practical lessons that help founders build demand before launch and improve their chances of commercial successPlay this episode now to discover the five lessons that will help you prepare the market, accelerate adoption, and give your MedTech product the strongest possible commercial launch.Full episode with Holley - #211Book 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.

Aaron Timm, CEO of Openwater, is driving the shift from single-purpose, room-sized equipment to multi-purpose, portable, light-weight medical devices designed on an open-source platform. Some tools use infrared light to measure blood flow in real time for applications such as stroke detection. Another device uses focused ultrasound to modulate tissue in the brain for treating neurodegenerative diseases and psychiatric conditions. The platform is designed so that a single hardware device can run multiple applications, allowing researchers to adapt and develop applications specific to their work, bringing innovation into the marketplace similar to the smartphone app environment. Aaron explains, "So we have two primary devices. One uses infrared light to measure blood flow and blood volume in real time. So that one is being used, for example, to measure blood flow to the brain to help determine whether someone is having a stroke. At the University of Pennsylvania, there was a study done using that device, where our device outperformed the existing stroke scales. The other device that we have is a focused ultrasound device. And what that device does is it uses sound waves or focused ultrasound to target and modulate tissue in the brain and elsewhere in the body. That's being used in research today for all sorts of neurodegenerative diseases, psychiatric diseases. And there's just a lot going on in the world of focused ultrasound, including using our devices."   "So this focused ultrasound device and the science behind it eliminates the need for drugs or surgery and just uses focused ultrasounds to modulate or stimulate things within the brain, for example. It's used for everything from depression, anxiety, Alzheimer's disease, and addiction. Many different indications are being addressed in research using these kinds of devices, including ours." #OpenwaterHealth #MedTech, #NonInvasiveCare, #PortableHealthcare, #PatientAccess, #HealthcareInnovation #FocusedUltrasound #LIFU #Hemodynamics #Openwater #OpenLIFU #OpenMotion #DigitalHealth #Neurotechnology #StrokeCare #AIinHealthcare #OpenSourceMedicine #ClinicalResearch #WearableMedicalDevices #HealthcareInnovation openwater.health Listen to the podcast here

Aaron Timm, CEO of Openwater, is driving the shift from single-purpose, room-sized equipment to multi-purpose, portable, light-weight medical devices designed on an open-source platform. Some tools use infrared light to measure blood flow in real time for applications such as stroke detection. Another device uses focused ultrasound to modulate tissue in the brain for treating neurodegenerative diseases and psychiatric conditions. The platform is designed so that a single hardware device can run multiple applications, allowing researchers to adapt and develop applications specific to their work, bringing innovation into the marketplace similar to the smartphone app environment. Aaron explains, "So we have two primary devices. One uses infrared light to measure blood flow and blood volume in real time. So that one is being used, for example, to measure blood flow to the brain to help determine whether someone is having a stroke. At the University of Pennsylvania, there was a study done using that device, where our device outperformed the existing stroke scales. The other device that we have is a focused ultrasound device. And what that device does is it uses sound waves or focused ultrasound to target and modulate tissue in the brain and elsewhere in the body. That's being used in research today for all sorts of neurodegenerative diseases, psychiatric diseases. And there's just a lot going on in the world of focused ultrasound, including using our devices."   "So this focused ultrasound device and the science behind it eliminates the need for drugs or surgery and just uses focused ultrasounds to modulate or stimulate things within the brain, for example. It's used for everything from depression, anxiety, Alzheimer's disease, and addiction. Many different indications are being addressed in research using these kinds of devices, including ours." #OpenwaterHealth #MedTech, #NonInvasiveCare, #PortableHealthcare, #PatientAccess, #HealthcareInnovation #FocusedUltrasound #LIFU #Hemodynamics #Openwater #OpenLIFU #OpenMotion #DigitalHealth #Neurotechnology #StrokeCare #AIinHealthcare #OpenSourceMedicine #ClinicalResearch #WearableMedicalDevices #HealthcareInnovation openwater.health Download the transcript here

Kunstmatige intelligentie belooft de gezondheidszorg sneller en beter te maken. Een bedrijf als Philips ontwikkelt bijvoorbeeld technologie om scans te begeleiden, beelden te verscherpen en artsen te ondersteunen. Maar het wantrouwen blijft groot. Willen we dat een computer meebeslist over onze gezondheid? Zijn de patiënten daar klaar voor, en hoe zien de zorgverstrekkers dat zelf? We spraken voor deze podcast onder meer met Tom Braekeleirs, professor medische technologie aan de UGent en auteur van het boek ‘Acceptable AI' over de toekomst van medische technologie. Links: Hoe technologie de zorg kan verlichten: AI moet artsen helpen, niet vervangen IBM komt met AI-platform dat je vertelt hoeveel je codeerproject gaat kosten Plots zijn goedkope AI-modellen overal prioriteit: ‘AI-labs voelen de hete adem van opensource' Microsoft-CEO Satya Nadella gooit OpenAI onder de bus Identificatie-app itsme krijgt vanaf volgend jaar verplichte gezichtsherkenning   Trends is een podcastkanaal van de redactie van Trends.--- --- Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

Today, we're joined by Richard Meehan, CEO of Velico, the Boston-founded medtech company that has established its international headquarters in Ireland and is developing a groundbreaking dry plasma manufacturing system that could transform emergency trauma care around the world.From ambulances and military operations to mass casualty response, Velico's technology enables blood centres to produce spray-dried plasma that can be rehydrated within minutes when every second counts.With recent support from the French military—a global leader in dried plasma production—the company is gaining international recognition for its innovative approach.In this episode, Richard shares his journey from leadership roles across FMCG, real estate and ICT into the fast-moving world of MedTech, discusses the challenges and opportunities of scaling a healthcare technology company internationally, and explains why Ireland is playing a central role in Velico's global growth strategy.Visit www.thinkbusiness.ie for more news and supports for start-ups and SMEs in Ireland. If you want to start and grow a business, ThinkBusiness.

What if the future of surgical training doesn't happen in the operating room? In this episode of Med Tech Gurus, we sit down with Dr. Danny Goel, orthopedic surgeon, clinical professor at the University of British Columbia, and CEO & co-founder of Precision OS, to explore how virtual reality and AI are transforming surgical education. Today's training environment is under pressure—reduced clinical hours, increasing procedural complexity, and a relentless focus on operating room efficiency are limiting opportunities for hands-on learning. The traditional "see one, do one, teach one" model is no longer enough. Dr. Goel shares how Precision OS is addressing this challenge with immersive VR simulation that allows surgeons to practice procedures on demand, receive objective performance feedback, and improve skills outside the operating room. With over 100+ orthopedic training modules and the ability to capture detailed performance data, the platform is redefining how surgical competency is measured and developed. We explore the shift from subjective evaluation to data-driven skill assessment, the importance of workflow integration for adoption, and how just-in-time training can improve both surgeon confidence and patient outcomes. If you're interested in medical education, surgical simulation, AI in healthcare, virtual reality training, or MedTech innovation, this episode offers a compelling look at how technology is reshaping the future of surgical training.

Antoine Pouppez co-founded neuroClues six years ago. Today it's raised over £25M and employs 40+ people across Belgium and France, building MedTech that treats neurological disorders through eye tracking.His approach from day one: if it's core to the product, you build it yourself, no matter how much longer or more expensive that is. James and Antoine get into why that decision holds up outside MedTech too, how he kept investors on side through a year long delay, and the one question that decides what's worth doing properly versus what can wait.More from James:Connect with James on LinkedIn or at peer-effect.com 

What if the success of your MedTech product is decided months before you ever launch it?Many clinician founders believe commercialisation begins once regulatory approval is achieved and the product reaches the market. In reality, the companies that achieve the strongest adoption are already building demand, educating the market, and creating advocates long before launch. In this episode, Hakeem unpacks Holly Miller's decision-making framework and explains why belief—not just evidence—is the foundation of successful MedTech adoption.Listeners will discover:Why clinical evidence builds credibility but doesn't automatically create adoptionHow to market the problem before marketing your MedTech productWhy building advocates and demand before launch gives MedTech companies a significant commercial advantagePlay this episode now to discover how to build belief, create demand, and give your MedTech product the best chance of commercial success before it even reaches the 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.

https://www.amazon.co.uk/Villain-Venice-Steampunk-Adventure-Expanded/dp/B0GYVW1ZM3?source=ps-sl-shoppingads-lpcontext&ref_=fplfs&psc=1&smid=A3P5ROKL5A1OLE Written By: Jonathan S Powell, Georgia Cook, Jonathan Morris Starring: Paul McGann, Tamsin Greig, Nicola Walker Duration: 221 minutes Colony Sunlight has been destroyed, ravaged by a ruthlessly aggressive galactic weed known only as the Krynoid. As the planet turns cold, sinister forces descend on the surface, and time runs out for the scattered survivors. Could salvation lie a hundred years ago - with a Doctor, a MedTech and a big blue box? 2.1 The Hunt by Jonathan S Powell Blackmailed by the unscrupulous Raynor Cross, Sunlight survivors Tiro Hart and Letty Hodan must battle the icy remains of the life they left behind. But they are not the only ones with their sights set on a pod. 2.2 The Harrow by Georgia Cook Nobody knows what really happened to Station One, Verdana's first, doomed colony. But after materialising in the path of a Krynoid, the Doctor and Liv are about to find out. 2.3 The Harvest by Jonathan Morris When a band of survivors reach a mysterious settlement, they are promised food, shelter and harmony. But deliverance in Greenhaven comes at a price - and Father Nature is ready to collect. This release will have a limited CD pressing of 1000 copies. On making her Big Finish debut, Tamsin Greig said: "This is my first audio Doctor Who - it's amazing how it's taken so long for Big Finish to ask me! Amesus Vail is on this distant planet and is pretty stressed with the isolation, the abandonment and having to keep this show on the road. If you go green on this planet, you're dying - it's a lovely inversion!" Producer, director and writer Jonathan S Powell said: "I'm thrilled to be back on the Krynoid homeworld for three more terrifying tales set soon after the events of Nightfall. Our scattered survivors are running on borrowed time in the present, while the Doctor and Liv battle another Krynoid incursion a hundred years before. "I'm especially delighted with the performers we've brought into the series this time around, not least the enormously talented Tamsin Greig in her Big Finish debut as Overseer Amesus Vail. Alongside Tamsin and our returning survivors, listeners will be treated to star turns from Karl Theobald and Simon Kane as a pair of deluded monster hunters, Juliet Aubrey as a ruthless executive, and Angus Wright as a fanatical plant-loving priest, who harks back more than a little to Harrison Chase. That's not to mention Paul McGann and Nicola Walker as the always dependable Eighth Doctor and Liv. "There's so much to enjoy here, and more story yet to be told - if anyone survives, that is." Writer Georgia Cook said: "I love the myriad of different ways that the Krynoid can be a monster. There's the body horror aspect, the transformative aspect, and it can just eat you! And then, it can also control you through your mind. So it's kind of a triple threat! With my story, I remember the producer Jon saying, minimal body horror, we're focusing on the horror of the plants as monsters in their own right. "Writing for the Eighth Doctor and Liv was great fun, because I've not written for those two before. Liv is such a steely personality and really can be in charge. Even with the Doctor gone, she can hold her own." Nicola Walker, who reprises her role as companion Liv Chenka from the Eighth Doctor Adventures series, said: "I like these stories when it gets very odd, with plants growing and killing us! But, you can draw real-world parallels too - it's otherworldly and imaginary, except there's something in there that has the bite of truth." Paul McGann (The Doctor ) Tamsin Greig (Overseer Amesus Vail) Nicola Walker (Liv Chenka) Abbie Andrews (Nurse Clarke Boyd) Juliet Aubrey (Raynor Cross) David Ault (Phillip) Gina Bellman (Katarina) Melody Chikakane Brown (Bryn Forrester) Ian Conningham (Fletcher Hart) David Hounslow (Wendalos) Simon Kane (Saber) Lara Lemon (Dr Felicia Chester) Jack Myers (James Hurcotte) Nye Occomore (Tiro Hart) Jonathan S Powell (Console) Em Prendergast (Letty Hodan) Christopher Ragland (Captain Kaleb / Darius) Karl Theobald (Mason Latch) Sarah Whitehouse (Maggie Hart) Angus Wright (Pater Dowlish) Becky Wright (Eleena Fitzgerald)

Die Schweiz erleichtert den Handel mit dem Verieingten Königreich – besonders im Dienstleistungsbereich. Das BAG verhindert eine Medtech-Regulierung für die Branche. Warum der Solarstrom nichts mehr wert ist. Warum ein Deutscher an die Spitze von Meteoschweiz kam.

In this episode of the Beautifully Broken Podcast, Freddie Kimmel talks with Jon Hacker, co-founder of Zenbud, about the broken incentive structures inside MedTech and academia — from the unnecessary gatekeeping around credentials and funding, to an insurance system that rewards defensibility over efficacy. Jon shares his personal path from an eleven-year-old fascinated by the nervous system to building a company focused on non-invasive, science-backed nervous system technology, and the two explore what it really means to "meet people where they are" instead of demanding a total lifestyle overhaul. The conversation then turns to Zenbud itself: how the device uses ultrasound (not electrical stimulation) to support the vagus nerve, the history and research behind vagus nerve stimulation, early tolerability and reaction-time data, and why Jon is skeptical of HRV as a standalone metric. They close out with a candid look at frictionless, daily-life-compatible wellness tech, Zenbud's 90-day guarantee, and where the product is headed next — including future plans for real-time brain activity feedback. Episode Highlights 00:01 Welcome to the Beautifully Broken Podcast and introduction of Jon Hacker 01:55 What drew Jon into health, wellness, and integrative technology 03:29 Why Jon believes MedTech is broken 06:14 Barriers to innovation in MedTech and academia 09:20 Insurance, reimbursement, and misaligned incentives 12:04 Freddie's perspective on the longevity and health optimization space 14:18 Meeting people where they are and building for real life 20:12 Introduction to Zenbud 23:36 How Zenbud works and why it uses ultrasound 27:00 The history of vagus nerve stimulation 32:58 Early results, tolerability, and reaction time data 36:07 Why HRV is a limited metric 39:50 Passive, frictionless use in daily life 42:43 The 90-day guarantee 49:52 Future vision for Zenbud 52:45 Where to find Zenbud and closing thoughts Get Zenbud: https://zenbud.health/beautifullybroken Use code BEAUTIFULLYBROKEN  Upgrade Your Health LightPathLED: https://lightpathled.pxf.io/c/3438432/2059835/25794 Code: beautifullybroken Silver Biotics Wound Healing Gel: https://bit.ly/3JnxyDD 30% off with Code: BEAUTIFULLYBROKEN MaxGen Labs: https://maxgenlabs.com/BEAUTIFULLYBROKEN CONNECT WITH FREDDIEWork with Me: https://www.beautifullybroken.world/biological-blueprintWebsite and Store: (http://www.beautifullybroken.world) Instagram: (https://www.instagram.com/freddie.kimmelYouTube: https://www.youtube.com/@beautifullybrokenworld Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

Robotics and automation are accelerating across healthcare, but scaling innovation still depends on having the right people in place. In this episode, Joe Solari, Managing Director at ZRG Partners, and Lori Prehar, Managing Director of Embedded Recruiting at ZRG, discuss how robotics, automation, and AI are transforming medtech, healthcare operations, and talent strategy. Joe explains how robotics can improve efficiency, reduce clinician burnout, and help healthcare organizations scale as automation expands. Lori shares why embedded recruiting has become an effective solution for companies navigating uncertain hiring needs and growth plans. They also explore the opportunities and risks of AI, including its impact on recruiting, compliance, security, and robotics. Tune in to hear how robotics, automation, AI, and flexible recruiting models are shaping the future of healthcare growth! Resources: Connect with and follow Joe Solari on LinkedIn Connect with and follow Lori Prehar on LinkedIn. Follow ZRG on LinkedIn and explore their website!

How can Europe ensure that groundbreaking health innovations actually reach patients? At the MedTech Forum 2026, we spoke with Niklas Blomberg, Executive Director of the Innovative Health Initiative (IHI), about the critical challenge of bridging the gap between innovation and patient uptake. We explored the role of public-private partnerships in accelerating medtech innovation, the importance of real-world evidence and health data, the opportunities and challenges presented by AI, and the need to move from policy discussions to practical implementation. The conversation also highlighted sustainability, competitiveness, and collaboration as essential drivers of Europe's future health innovation ecosystem. Learn more about IHI and its health innovation projects: https://www.ihi.europa.eu/

Brent Lavin, principal at Ironwood Medtech Partners, shares how he helps early-stage medtech companies build commercial strategies from concept through commercialization and exit. Brent reflects on his path from electrical engineer to launch expert, including lessons learned after seeing how overbuilt product features can complicate V&V and FDA review, and why founders must make early decisions with the end in mind. He discusses common startup pitfalls, the importance of pairing technical innovation with a strong commercial plan, and practical leadership insights on hiring “the right seat,” delegation, and setting clear standards while allowing teams flexibility in execution.    Guest links: https://www.linkedin.com/in/brent-lavin/ 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 084 - Brent Lavin [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 Brent Lavin. Brent is currently principal at Ironwood Medtech Partners, where they help build the commercial logic into medtech startup innovation from concept through commercialization and exit. As an engineer turned launch expert, Brent has helped commercialize 20+ 510K PMA products and led the buy side of four M&A transactions, so he knows what buyers value beyond the science. With a diverse background from GE Healthcare to C.R. Bard to BD to now leading Ironwood Medtech Partners, he thrives on helping early-stage companies navigate the complex healthcare landscape and build successful companies. All right. Brent, welcome to the show. So glad to have you here today. [00:01:39] Brent Lavin: Yeah, great to be here. Thanks so much for the invite. I appreciate it. [00:01:42] Lindsey Dinneen: Absolutely. Well, I'd love if you would start by just sharing a little bit about yourself, your background, and what led you to medtech? [00:01:50] Brent Lavin: Yeah. So, I'm Brent Lavin. I live here in Phoenix, Arizona. I've recently founded Ironwood Medtech Partners, which is my company helping early-stage medtech. But I spent nearly 20 years in strategic medtech, and so I originally came to the industry through the engineering function. I was an electrical engineer in product development and innovation. And after three or four years of that, decided I wanna move over into what was, what is traditionally product management. And so, through my MBA program and then starting with GE Healthcare, I've spent the last 20 years at this intersection of R&D innovation, strategy, business development, and marketing. And so, really great run. Have been on the buy side of several M&A transactions, and I try to bring all of that experience to the early stage so that, you know, companies as they start out, can be building for the future. And so, it's been a great journey in medtech, and I've loved it so far. [00:02:46] Lindsey Dinneen: Yeah. Okay, so, so many things to ask about, but I'll, I'll start here. So, all right, so you're sa- you know, as you, you mentioned building towards the future and especially with these young startups that might not have a lot of experience in that particular kind of environment, or they're leading their company for the first time. What are some of the things that you see that maybe are pitfalls to avoid? Just, just like maybe some of the things that you've seen startups struggle with a little bit, and how can we help them mitigate those risks? [00:03:17] Brent Lavin: Yeah, there is a lot there, but let me just start by saying there is no linear path, and it is a very circular, ongoing process as you work through those early stages. And we call it the fuzzy front end for a very good reason. And sometimes you need to go down paths to realize that's not the right path, and you need to be comfortable with that. But at the end of the day, one of my goals is to help early-stage companies build with the end in mind because whether you acknowledge it or not, you're making decisions today that are ultimately gonna affect how you commercialize in the future. And so at least being able to make those decisions with your eyes wide open and understanding the trade-offs that are going on. And so for somebody that's been at the very end of that process, I, I can help inform, you know, those early stages so that you make priority decisions and trade-offs, you know, with full-scale information. [00:04:17] Lindsey Dinneen: Okay. Yeah. Well, I, I love the fact that you highlighted it's not a linear path, and there are a lot of things that go into, of course, the success of a startup. I'm wondering, in, in your role now, what are some of the areas which you see successful startups really thrive in as they're working with, with somebody like you to help make them successful from the start? [00:04:42] Brent Lavin: Yeah. Thanks for that question. I love working with early-stage founders that are passionate about their technology but especially those that realize where they may need to supplement their technical background with more of a commercial mindset. And so the, the people that work, that I work best with, are open to inputs and consideration of other options as they go through that process because you know, the, the famous saying, "What got you here is not what's going to get you there." And so while technical innovation is, is key that may not lead to an acquisition if you can't tie it to a strong commercial plan. [00:05:22] Lindsey Dinneen: Mm, mm-hmm. Yeah, so actually this is an area that I'm very curious about even in your own journey is, so you started off with that technical background as an electrical engineer, and I'd love to hear a little bit more about that as well. But maybe if you don't mind sharing a little bit about the transition or the learning process of going from that as a really good base to also being able to understand the full life cycle and how to make something succeed. [00:05:47] Brent Lavin: Yeah. Well, let me kind of go back to those engineering days and talk a little bit about how I made that pivot from engineering into product management. And to be honest, I didn't know exactly what I was doing at the time, but a-as an engineer, I was working with a product development team where we were creating a project. I was at a s- a contract design manufacturing company, and we were working with an outside company that owned a patent for a laboratory blood culturing instrument. And so we were their engineering partner, and what I saw firsthand was unfortunately, this customer at the time did not have full insight into the workflow and how the device was used in practice. And so as an engineering team, we frankly overbuilt many options into the product in order to try to s-satisfy everybody. And that seemed attractive at the time, but ultimately when we got to V&V, verification validation, and the FDA review process, it was a real struggle to get this on market. Now we ultimately did, but the epiphany for me was, I am really good at understanding engineering trade-offs and working with engineering teams to go through the process of evaluating different options. But I also really like working with customers and understanding what moves the needle and what's the difference between a nice to have and a need to have. And so, it was that kind of experience firsthand that led me to say, "I wanna operate at this intersection and really operate in both sides of that equation." And so ultimately I decided I needed to get an MBA in order to do that. So I left a, a good paying engineering job right after I got married and we moved to Madison and I got my MBA and then, you know, that ultimately led to GE Healthcare and, and then, you know, continued career in medtech. So thanks for asking that question. [00:07:43] Lindsey Dinneen: Yeah. Well, okay, so your leadership journey, of course, has, has evolved over time as, as often happens, and, and you've gone from leadership positions within other organizations to, of course, now leading your own. And I'd love if you'd just share a little bit about that journey of, of growth and discovery, maybe some, you know, lessons learned along the way. [00:08:06] Brent Lavin: Yeah. So, let's talk a little bit about kind of my formal leadership in the, you know, corporate structure and organization. I would say, we were chatting beforehand that, you know, I really moved through slowly at the beginning of my leadership from one person to three people to five people. And as an ambitious person, I always felt like that was too slow. And so, but I think it was those foundational aspects of working very closely one-on-one with people, hiring, deciding who to hire, selection, onboarding having crucial conversations about performance management and how to put people in the right seat to be successful, all occurred when my leadership span was frankly smaller than probably I was hoping it would be. But at the proper time, my leadership expanded very quickly from five to seven and ultimately 22 people within about an 18-month period. And if I had not had those slow steps along the way, I don't think I would've been ready for that and I, I would've struggled. And so, even though my ambition was high, the pace was just right in order to be successful in that. Now, to your second part of the question of, you know, how do you then transition to this, this new role? That has been a learning experience, and I'm not sure I have it mastered but it is all about influence. And so, you know, leadership, even in a formal organization, while you can be connected on the org chart, ultimately boils down to influence. And so my goal is to influence early-stage companies to understand the trade-offs that they're making and hopefully help them chart the best path forward for the goal that they have, you know, individually. Every company is built differently, and so I try to channel what their goals are into my recommendations. [00:10:02] Lindsey Dinneen: Absolutely. So you mentioned something that is brought up often, but I think it's a concept that would be worth diving into, and that's the concept of the right seat, and I would love if you would share a little bit more about your philosophy behind that and how, as a leader too, if you know that there's perhaps somebody who's a great fit for your organization but isn't in the right seat, how do you help make that happen? [00:10:29] Brent Lavin: Yeah. So this is back to the seminal Jim Collins book. You know, get the right people on the, on the bus and then get them in the right seat, correct? And so I always tried to select the person first and then find the opportunity. And there are times where you need to pivot people. So let me tell a, a quick anecdote about, you know, a situation where we had somebody on my team, and this person had progressed through different product management roles, but this person also had a project management background and was really passionate about project management and brought those skill sets to product management. But they are different, and that... Her passion was in project management, and so I knew of some upcoming and different opportunities in the organization that would be very project management focused and that, that position was not even on the org chart at the time. But as I had discussions and, and understood that that was becoming a reality, then I turned and, and offered that to the, to the person and ultimately they, they took that new opportunity. And so, it's really understanding really their long-term goals as well as, you know, their strengths, their natural strengths. Not just where they're operating, but what their natural strengths are, and then sometimes even creating an opportunity for them. [00:11:51] Lindsey Dinneen: Mm-hmm. Yeah. Yeah, and so, okay, so, so you've had kind of, a really cool opportunity to get a really good look into some of these startup companies who, you know, their founders might not be in a place where they're able to necessarily hire a whole bunch of people right away. How can you come in and support them when they're, say, like really young, maybe pre-seed, trying to figure out what the next right step is and, and able to sort of help lead them also in that transition of, you know, perhaps single founder to also a leader of a company? [00:12:32] Brent Lavin: Yeah. That's a great question, and I'm early in that journey, right? And so, maybe not some specific examples around that, but certainly again, you know, leadership is influence. And you know, I try to understand as a leader of people in a, an organization what everybody's goals are, personal and professional goals are, and then match, you know, again, what I can do to, to their, to their interests. And so when you talk about, you know, early stage CEOs, sometimes it's just a matter of listening as an unbiased outside observer who has no money in the company. And so, it can just be providing perspective from years of experience and asking insightful questions, you know, even before there's a relationship, a business relationship, between, you know, my company and theirs. And the goal is to help everybody be successful. Like, I'm a passionate medtech leader that wants, you know, th- these innovations to reach market. And so, people have lifted me up along the way, and if, if I can do that just in, in conversations and mentorship, certainly willing to do that and have done that. But as, you know, a CEO transitions then into seed and Series A, just providing, you know, again, leadership perspective from, you know, my corporate experience can be helpful. Because ultimately people are not gonna do things exactly the same way that you've done them as an individual contributor, and you have to become comfortable with allowing people, giving people the, the guardrails, and then allowing them to operate in their own style to achieve the results that you've laid out for them. [00:14:20] Lindsey Dinneen: Hmm. So yeah, and th-that's been something that's been talked about quite a bit is that art of delegating, and how do you give your people the right guardrails without making it so narrow that it feels like you're kind of micromanaging, but you ha- you have to maintain culture and brand, you know, like tone in the way that you speak. So, what are some strategies or tips that you might have for, for a leader who is in the position, needs to delegate? This is maybe a first time. It's a little bit hard to let go of the baby, as it were. So, so how do you help them navigate that? [00:14:55] Brent Lavin: Ye- yeah, I, I would go back to my own experience where, you know, I probably didn't do this the best the very first time that I had people on my team and was delegating. And I would say that most high achievers struggle with delegation for the first time because people are going to do things in a different way than you did. And I tried to teach my way, but as I grew and expanded and got, you know, mentorship and, and learned through that process, I started to go f- you know, higher o- on the ladder to, you know, values and culture and expectations, to your, to your point before. So, as a leader you have to be consistent and just unending in your communication of expectations, values, and standards, and then hold people to those. And so I, I say this often. I live in South Chandler, Arizona, and Scottsdale is maybe 40 minutes away. You know, a new leader would say you know, "You gotta go up the 101, you need to take Exit this and that to get to the coffee shop." Where as I grew more comfortable and confident, I would say, "We're gonna meet at this coffee shop in Chandler." And if they wanted to take surface streets and hit all the stoplights, so be it. And so you gotta become comfortable with that. But at the same time, our standard is "We're gonna meet at this coffee shop at 11 o'clock sharp, and I expect you to be there." [00:16:26] Lindsey Dinneen: That's a great analogy. I love the way you put that. Thanks for sharing it. Yeah, that's-- and that's a really interesting way of thinking about it, is there's, there's many avenues to getting something done correctly and to meet those expectations that you set forth, but there can also be room for creativity on how that's done, how that's accomplished. [00:16:46] Brent Lavin: Yeah. You know, one of the team values that, that I had with my most recent team was around this idea of, of play to win. And you know, over time, I actually adjusted that with some feedback and some further, you know, kinda study on leadership toward striving for excellence. And so I think the play to win was a little bit narrow in that you can't always control everything around you. And winning is an outcome that may be dependent on some other factors that, that you can't influence. And so that was a little bit narrow and, and too outcome-focused. But strive- striving for excellence was something that we could talk about daily, and you may not win, but as long as you strive for excellence in whatever we're asking you to do, like that's the standard. And so, that became a lot more robust, I would say, in the conversations that we had around setting and ensuring expectations. [00:17:45] Lindsey Dinneen: Yes, I love that. Excellence over perfection, especially for those of us who are what I would fondly refer to as a recovering perfectionist. So. [00:17:53] Brent Lavin: Mm-hmm [00:17:54] Lindsey Dinneen: I love that. [00:17:56] Brent Lavin: Yeah, it's a present tense recovering, right? Because we're never fully recovered. But... [00:18:01] Lindsey Dinneen: That's right. That's right. Absolutely. No, I love that. So just out of pure curiosity, when you were, say, I don't know, seven, eight years old, could you have possibly imagined becoming an engineer and/or doing what you do now, which is so much even more robust? [00:18:18] Brent Lavin: Oh my gosh, Lindsey, I love this question, because I couldn't, you know? I didn't. I grew up in small town USA and you know, I, I was really focused on it, you know, being the best at any single sport I could play. I, I was just a ball kid and, and but I loved entrepreneurship. And it's funny you say this because I think in high school, you know, they have those like, "What are you gonna do when you grow up?" I wanted to own a sports bar. And yeah, so like I wanted to help serve good food and, and just have a lot of TVs around and and be an entertainment spot. But I just kind of had that entrepreneurial, you know, itch. And so I, I pretty well knew I was gonna be an engineer just because I was good at technical things, and I loved it. Like, it wasn't work to me. But I didn't even understand what medtech was. And I was 22 years old in my first engineering job. I was six months into the job, and I ended up in the ER on the weekend, and excruciating abdominal pain. And they ran a CT scan, and they found the problem, they relieved the symptoms, they sent me home, and they said, "You need to see the surgeon on Monday morning." Not really understanding what was going on, but I distinctly remember being in that surgeon's office the next week and seeing the axial image of the CT scan on the light box, like the physical light box back then. And I was fascinated. I was fascinated that they chopped my body like a loaf of bread, and within about 30 seconds they could identify the issue. And you know, the surgeon said, "Y- you have this recurrent diaphragmatic hernia, and you're gonna be in surgery in two days." And so I was not scared. I was more fascinated than anything, and that is what crystallized, you know, my need to get into, to medtech. I didn't even know it existed, but I said, "I wanna go do that." And if you fast-forward about five years, there I was working for GE Healthcare, you know, the maker of those CT scanners. And so, I think medtech is really hard. It is not the most glamorous industry. So we all need that why, and for me, again, that Monday morning in the surgeon's office is my why. [00:20:31] Lindsey Dinneen: Hmm. I love that. Yeah, and I love that that's your why, and sort of a follow-up question to that then is, are there any moments that stand out to you along your journey being in medtech that particularly reinforced to you, since making that decision, say, that you are in the right place at the right time? [00:20:52] Brent Lavin: Yeah, and, and I don't mind talking about this. I'll tell this other story. About 12 or 13 years ago, I ended up learning that I had an autoimmune condition, and if you fast-forward, I, I was on some pharmaceuticals, and I've recovered, and I'm all back to normal, but I still live with that. But you go to today, and there are neuromodulation solutions that are addressing autoimmune conditions. And so we're now giving patients a choice between a device-based intervention and a pharmaceutical intervention or a pharmaceutical treatment. And I did not love those pharmaceuticals. They, they had certain side effects and I didn't wanna be on them the rest of my life. Now, I've weaned off of most of them, but patients today are getting an option for a device-based intervention, and so that's what medtech is about. And so when I hear stories of like th- like this, I'm like, "I'm exactly in the right place." And so, there's so much opportunity for us to innovate and impact pa- impact patient lives whether that's ourselves, you know, our family members, or people we may never meet. [00:22:03] Lindsey Dinneen: Yeah. Yeah, thank you for sharing that story. That's-- it's incredible to see. I think one of the best parts about being in the industry is getting to feel hope on a daily basis, yeah? 'Cause there's always something new coming out. These, like you said, medtech is really hard. There are a lot of really tough days, sometimes very not glamorous, and you just... if you have that why, that helps pull you through those days. But I really love what you touched on there of how those innovations that are coming through, that is reason for hope and just optimism again, especially in a, in a world that needs that really badly. [00:22:45] Brent Lavin: Yeah, I think it's easy to be cynical about healthcare. But I guess I choose hope. And yes, we have some structural things that we need to work through. Yes, we have a reimbursement climate or regulatory structure. But to me, that's just a great puzzle, and the, the innovations that do have an impact, not only on healthcare patients, but also economics, are the ones that are gonna win. And so I don't mind that it's a high bar, you know? And so, that just means that we need to all be a little bit better, 1% better, and continue to make a difference. [00:23:20] Lindsey Dinneen: Yeah. No, that's, that's so great. I really love that. Okay, so pivoting the conversation a little bit just for fun. Imagine that you were to be offered a million dollars to teach a master class on anything you want. It can be within your industry, but it doesn't have to be. What would you choose to teach? [00:23:41] Brent Lavin: Yeah. I love that you asked this question, and I could go a lot of different directions. I, I think I'm gonna say, you know, I would love to teach the process of structured customer insights. And so I'm thinking back to the whiteboard of an early stage and then throughout the con- the, the journey of a company. But I think there's a big gap between asking questions to learn and asking the best questions that can ultimately influence your business decision. And so it's not only what you're asking, it's how you're asking it, why you're asking it, and then doing the proper follow-up during the conversation in order to learn the true insight. And so I love baking and I love barbecue, maybe back to my, you know, sports bar dreams. But I think there's a big difference between following the recipe of a baking, you know, process, and doing barbecue, which is very process-oriented and no two things are the same. And so I think we need to approach customer insights a little bit more like barbecue, where you definitely have a goal and a process, but you're willing to adjust and make the changes as you learn in order to affect, you know, the business decisions. [00:25:06] Lindsey Dinneen: Hmm. Yeah. Okay. I really like that. I also like the illustration of the barbecue analogy. That's, that's fun. So okay, so I do have to ask a follow-up question then. So how did this skill set come about for you? Is this something that you, you learned, say, during observations? Or how did you develop this, this masterclass, shall we say? [00:25:28] Brent Lavin: Yeah. I, I think it's, some of it's through my own kind of learning in having conducted just hundreds of physician interviews. And I think, again, early in my career, I used to go through a questionnaire step by step and, and I'd get to the end and I'd have a report, but I may not have the insight. And I think as, again, as I became more comfortable with that process, I would, I would take U-turns or I would take the fork in the road, depending on where the physician was going, and continue to learn maybe not something that was on my roadmap, but something I still needed to learn. And then as I became in- came into leadership, I, I think I just saw it again with early product managers that wanted to follow a recipe and wanted to check a box toward customer insights rather than, again, truly getting in the customer's shoes. I think one of the most fun things of my job in upstream and innovation marketing is when I can interview enough physicians about a particular narrow procedure or product concept, if I can interview enough of them, s- typically between 20 and 30, depending on how complex, and I can start to think like them. And that's the ultimate of a product manager, is to think like the physician. Again, it all depends on how complex the procedure is and whatnot, and we should always be striving to learn. But when you can achieve this secondary kinda personality that mirrors what you've heard from all of these conversations, there's nothing better. [00:27:10] Lindsey Dinneen: Really cool. Okay, excellent. Thank you All right. And then how do you wish to be remembered after you leave this world? [00:27:19] Brent Lavin: Wow. I haven't thought about this in a while. I think, how do I wanna be remembered? Obviously, you know, for my family by, like, leaving, you know, a good family legacy, and also just, I showed up. I just put my shoulder down, did the best I could, certainly wasn't perfect. But I tried to just do the best with what God gave me, and it happens to be in the medtech world right now. And I think I'm uniquely gifted for where I'm at. But I still wanna make more impact over, you know, the next couple of decades. [00:27:55] Lindsey Dinneen: Mm, mm-hmm. Yeah, absolutely. Okay, and then final question. What is one thing that makes you smile every time you see or think about it? [00:28:06] Brent Lavin: Yeah, I, I guess I gotta just go back to my family right now. I got four teenagers, you know, and we're just in an awesome period of life, and I was traveling last week, and just being able to come home, you know, see my wife, see the kids, can't help but smile. So, you know, my two boys are twins, are graduating high school, and those days are, are kinda short, so I'm just trying to soak up every minute of that right now. [00:28:30] Lindsey Dinneen: That's wonderful. I love that. Well, this has been a really great conversation, Brent. Thank you so much for joining me today. We are so honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational, and safe environment. So thank you so much for choosing that charity to support, and also thank you for continuing to work to change lives for a better world. I'm grateful for you and for your impact on the industry. [00:29:07] Brent Lavin: Well, thanks for this conversation. I've really enjoyed it, and I, I can't wait to continue to stay in touch. [00:29:11] Lindsey Dinneen: Absolutely. Thank you so much. [00:29:14] 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.

Have you ever wondered why a clinically proven MedTech product can achieve regulatory approval, generate positive feedback, and still fail commercially?Many clinician founders believe that strong clinical evidence is enough to drive adoption. Unfortunately, healthcare doesn't work that way. In this episode, Hakeem speaks with Holly Miller about why adoption is engineered long before launch and how behavioural science, market conditioning, and stakeholder alignment help transform innovative MedTech products from interesting ideas into the new standard of care.Listeners will discover:Why clinical evidence alone rarely changes behaviour or guarantees adoptionHow to move your MedTech product from a "nice-to-have" to a "must-have" for the right audienceThe practical adoption strategies that successful MedTech companies use before launching into the marketPlay this episode now to discover how to engineer adoption before launch and give your MedTech product the best chance of achieving commercial success and becoming the new standard of care.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.Visit Holleys website for launch assessment belaunchready.com

Medical technology is moving quickly, and the companies that succeed will be the ones that stay connected, think strategically, and solve the right problems. In this live episode from DeviceTalks Boston, Etienne Nichols, MedTech Guru at Greenlight Guru and host of the Global Medical Device Podcast, discusses the major shifts shaping the medical device industry. He shares insights on global regulatory harmonization, tougher funding conditions, the growing role of AI, and why data strategy matters more than ever. Etienne also explains why companies need to understand their true user population, challenge assumptions in product development, and prepare for a future where medical devices work together as connected systems. Tune in to learn how medical device companies can navigate change, use data more strategically, and build solutions that better serve users and the broader healthcare ecosystem! Resources: Connect with and follow Etienne Nichols on LinkedIn. Follow Greenlight Guru on LinkedIn and explore their website. Listen to the Global Medical Device Podcast here. 

Great technology doesn't win—visibility does. In this episode of Med Tech Gurus, we sit down with Lauren Schafer, Founder of Lakehouse Digital Media, to explore why so many MedTech and life sciences companies struggle to gain traction—not because of weak innovation, but because of weak visibility and storytelling. Lauren works with founders and leadership teams to turn expertise into credibility, helping companies show up where investors, clinicians, and decision-makers are actually evaluating solutions. From LinkedIn thought leadership to modern SEO strategies shaped by AI, her approach focuses on one core idea: if you're not part of the conversation, you're not part of the decision. We dive into why traditional SEO is rapidly evolving, how platforms like LinkedIn and podcasts are becoming primary drivers of discovery, and why long-form, conversational content is now critical for AI search visibility. Lauren also shares practical strategies for repurposing content, maximizing conference ROI, and building a scalable marketing engine through fractional teams. If you're a MedTech founder, healthcare executive, or startup leader looking to break through the noise and accelerate growth, this episode delivers a practical playbook for turning visibility into real business momentum.

Regulation gets you approved. A go-to-market strategy gets you adopted.The question is: are you spending more time preparing your medical device for approval than preparing it for commercial success?Many clinician founders believe launching a medical device starts with regulation, manufacturing, or raising investment. But by the time you're thinking about those things, many of the decisions that determine commercial success have already been made. In this episode, Hakeem shares a practical seven-step framework to help you validate the problem, build the right evidence, develop a go-to-market strategy, and create the foundations for successful commercialisation and future expansion into export markets.Listeners will discover:The seven stages every clinician should complete before commercialising and exporting a medical deviceWhy validating the problem, evidence, and go-to-market strategy matters more than rushing to launchHow to identify the biggest commercial constraint holding your MedTech business back and prioritise the next step towards adoption, sales, and international growthPlay this episode now to benchmark your progress against the seven-step framework and discover the next step that will help you commercialise, export, and grow your medical device business with confidence.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.

La inteligencia artificial es una rama de la informática que simula procesos de inteligencia humana mediante algoritmos y modelos de aprendizaje automático. En medicina, se aplica para el diagnóstico, pronóstico, personalización de tratamientos, análisis de imágenes médicas y gestión de datos clínicos, entre otros. Nuestro invitado es el Dr. Jhonatan Bringas Dimitriades, un experto en el tema y que nos acompaña desde Holanda.  El es médico peruano y líder reconocido a nivel mundial en salud digital, inteligencia artificial e innovación transformadora en el cuidado de la salud. Es el CEO y cofundador de Lapsi Health, una empresa de tecnología de la salud que está redefiniendo la auscultación y la interpretación de signos vitales mediante diagnósticos basados en sonido impulsados por IA y biomarcadores digitales de próxima generación. En 2025, el Dr. Bringas fue nombrado uno de los 25 mejores ejecutivos de MedTech del mundo por The Healthcare Technology Report, y una de las 50 principales voces en salud por Medika Life en 2022. Instagram: @‌digitalhealthdoc www.keikku.health ¿Tienes algún comentario sobre este episodio o sugerencias de temas para un futuro podcast?  Escríbenos a pediatrasenlinea@childrenscolorado.org.

In this episode of Medsider Radio, we sat down with Dr. Sudhir Srivastava, founder, chairman, and CEO of SS Innovations (Nasdaq: SSII). The company's SSi Mantra surgical robotic system supports a variety of surgical robotic procedures, including cardiac surgery. Sudhir brings more than three decades of experience in minimally invasive and robotic cardiac interventions, having served as Director of Robotic Cardiac Surgery at the University of Chicago and founder of the International College of Robotic Surgery. A pioneer in the field, Sudhir has performed more than 1,400 robotic procedures, including over 750 beating-heart totally endoscopic coronary artery bypass (TECAB) surgeries.In this interview, Sudhir discusses what it takes to democratize robotic surgery beyond affordability, how SS Innovations built teleproctoring, telesurgery, and the supporting infrastructure for its robotic platform, and his milestone-based approach to financing a capital-intensive medtech company. 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 Sudhir Srivastava, 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(03:01) - Sudhir's journey from performing the world's first beating-heart robotic bypass to founding SS Innovations (07:14) - The 22-year-old patient who became the catalyst for Sudhir's affordable robotic surgery platform (08:59) - Building Mantra 3 from the ground up in just five months (12:14) - Inside the engineering process that eliminated months of costly iteration (16:20) - The question that shaped SS Innovations: "How do you democratize access?" (27:10) - From one office to performing 24 telesurgeries in 12 hours across India (29:29) - How a mobile training bus became part of Sudhir's answer to make robotic surgery accessible (33:49) - Lessons from commercializing a surgical robotics platform across developing markets (39:43) - Starting with just $5 million: Sudhir's milestone-based approach to fundraising

Nederland kan jaarlijks ruim 350.000 ziekenhuisopnames en bijna 500.000 consulten voorkomen door patiënten thuis te volgen in plaats van in het ziekenhuis. De technologie is er, werkt en groeit hard, maar de brede opschaling komt moeizaam van de grond. De grootste obstakels zitten niet in de zorg zelf, maar in de manier waarop die wordt bekostigd en in de versnipperde uitwisseling van patiëntgegevens. In deze aflevering van BNR Beter bespreekt Nina van den Dungen de opkomst van thuismonitoring en de virtuele verpleegafdeling. Te gast zijn Michael van Herwerden, internist-intensivist bij het Erasmus MC en initiatiefnemer van de virtuele verpleegafdeling, en Jan Willem Spijkman, sectorbankier gezondheidszorg bij ING en medeauteur van een themastudie over thuismonitoring in ziekenhuizen. Van Herwerden legt uit hoe de virtuele verpleegafdeling werkt: de diagnose wordt in het ziekenhuis gesteld, maar het herstel verplaatst naar de huiskamer. Patiënten meten thuis een paar keer per dag zelf hun bloeddruk en zuurstofgehalte en vullen een vragenlijst in; een gespecialiseerde telenurse beoordeelt die waarden binnen het uur en schakelt bij afwijkingen de behandelend arts in. Bloedafname loopt via een regionale prikdienst, en zelfs een infuus met antibiotica kan thuis, met hulp van een technisch thuisteam. Het Erasmus MC blijft medisch verantwoordelijk alsof de patiënt is opgenomen. Zorgpaden voor onder meer hypofyse-operaties, bacteriële infecties en hartfalen laten zien wat al kan en waar de grenzen liggen, bijvoorbeeld bij medicijnen met een nauwe marge. Spijkman schetst de urgentie: het personeelstekort loopt op van zo'n 70.000 vacatures nu naar ruim 240.000 in 2034, terwijl de zorgvraag door vergrijzing en multimorbiditeit blijft groeien. Ongeveer de helft van de ziekenhuiszorg zou thuis kunnen plaatsvinden. Toch remt de bekostiging de opschaling af: een patiënt die naar het ziekenhuis komt, levert via de diagnose-behandelcombinaties meer op dan een belletje of een meting op afstand. Volgens Spijkman ligt de sleutel bij afspraken tussen ziekenhuizen en zorgverzekeraars, zoals een aanneemsom voor complexe zorg, zodat ziekenhuizen ruimte krijgen om zorg thuis op te schalen. Transitiegelden uit het Integraal Zorgakkoord en de komende doorbraakmiddelen van VWS moeten die verschuiving verder aanjagen. Ook de uitwisseling van patiëntgegevens komt aan bod. Nederland koos ooit tegen een landelijk EPD, wat volgens Van Herwerden een grote misser was. Waar België en Finland met systemen als Kanta vooroplopen, werken initiatieven als Digizorg, Zorgviewer en CumuluZ hier nog aan een landelijk dekkend netwerk, met de Europese EHDS-verordening in 2031 als stok achter de deur. Over deze podcast BNR Beter is het wekelijkse programma van BNR Nieuwsradio over een toekomstbestendige zorgsector. Elke week bespreekt presentator Nina van den Dungen met zorgprofessionals, ondernemers en beleidsmakers hoe de Nederlandse zorg met technologie, innovatie, regelgeving en wetenschap beter kan worden. BNR Beter is elke maandag om 15:30 op de radio te beluisteren bij BNR Nieuwsradio, en vanaf dat moment ook als podcast via deze feed. Over de makers Nina van den Dungen (1987) is freelance journalist en als radio- en podcastpresentator al ruim 15 jaar verbonden aan BNR. Zo is ze regelmatig te horen als presentator van de nieuwsprogramma's in de ochtend- en avondspits en daarnaast presenteert ze wekelijks de beleggingspodcast Doorgelicht en BNR Beter over de zorgsector. Stijn Goossens (1996) is de redacteur van BNR Beter en plaatsvervangend presentator. Bij BNR houdt Stijn zich bezig met onderwerpen over tech, wetenschap en innovatie. Hij presenteert ook de podcast Op de zaak en test elke vrijdag een nieuw techproduct in de Ochtendspits op BNR. Hiervoor was Stijn werkzaam voor NTR Wetenschap en techplatform Bright.See omnystudio.com/listener for privacy information.

MedTech companies invest heavily in acquiring customers, but many still lack a clear strategy for retaining, expanding, and learning from them. Fortunately,  SaaS and tech already solved this years ago through the creation of a commercial function called Customer Success. In this episode, Rupal Ayer, Senior Director of Customer Success at Solventum, discusses why Customer Success should become a formal business category in healthcare. He explains how combining customer experience with customer outcomes can strengthen retention, guide enterprise decisions, and improve commercial performance. Rupal also shares how Customer Success connects sales, marketing, and service around the customer journey while helping organizations move from transactional vendors to trusted advisors. And building a culture that translates customer reality into enterprise action. Tune in to learn how embedding the voice of the customer at the center of enterprise decision-making can improve business performance and create better experiences for clinicians and patients. Resources: Connect with and follow Rupal Ayer on LinkedIn. Follow Solventum on LinkedIn and explore their website.

Have you ever wondered why some MedTech products achieve adoption and international success, while others never make it beyond regulatory approval?Many clinicians believe that solving a genuine clinical problem is enough to build a successful MedTech business. In reality, commercial success starts long before regulatory approval. In this episode, Hakeem shares five key lessons from his conversation with Jordan Morrison, covering the mindset, commercial strategy, funding, and adoption principles that help turn innovative ideas into commercially successful MedTech products ready for export markets.Listeners will discover:Why solving a clinical problem alone won't guarantee adoption or commercial successHow to build commercial thinking into your MedTech product from day one to support future export opportunitiesThe founder mindset, validation strategies, and decision-making principles that help move products from innovation to international growthPlay this episode now to discover the five lessons that can help you commercialise your MedTech product with confidence and build the foundations for successful expansion into export markets.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.

Duane Mancini, Founder and CEO of Project Medtech, a Cleveland-based platform helping medical technology companies move from promising invention to real patient impact.What began as a podcast has evolved into a broader ecosystem of consulting, events, education, investor connectivity, and community-building for Medtech founders navigating the difficult path from idea to market.In our conversation, Duane and I explore his path from science and research into entrepreneurship, how Project Medtech grew from a curiosity-driven podcast into a larger platform, and what founders often underestimate about building in Medtech. We talk about regulatory strategy, reimbursement, clinical validation, fundraising, the importance of team over product, and why Ohio may have a unique opportunity to become a more important node in healthcare innovation.Duane is thoughtful, mission-driven, and deeply committed to helping more life-changing technologies reach patients. Please enjoy my conversation with Duane Mancini.00:00 Building Trust Through Storytelling07:53 The Evolution of Project MedTech12:30 The Entrepreneurial Journey Begins20:37 The Founding Team Dynamics23:43 Lessons from 250+ Conversations28:58 De-risking in Life Sciences33:38 Navigating Capital in Life Sciences38:35 Redesigning the Market Entry Process41:24 Understanding Economic Impact in Healthcare44:18 Measuring Impact and Success48:11 Optimism in Life Sciences and Med Tech50:46 Opportunities for Ohio's Life Sciences54:44 Building Supportive Ecosystems59:23 Outro-----LINKS:https://www.linkedin.com/in/duanemancinihttps://www.projectmedtech.com/-----SPONSOR:Cerity PartnersCerity Partners, a full-service investment and wealth management firm serving high-net-worth individuals, entrepreneurs, and business owners, is proud to sponsor Lay of The Land. The firm has local roots in Cleveland and across Ohio, and like this podcast, Cerity Partners advisors specialize in serving the interests of local entrepreneurs and business leaders. The firm's national presence means it can offer the resources and specialized knowledge of the largest institutions with the independence and service of a neighbor. The Cerity Partners Cleveland team understands the complexity that comes with wealth, and they adhere to fiduciary standards. Discover the financial lay of your land.Learn more at https://ceritypartners.com/NPR or call 216-464-6266.Roundstone InsuranceRoundstone Insurance is proud to sponsor Lay of The Land. Founder and CEO, Michael Schroeder, has committed full-year support for the podcast, recognizing its alignment with the company's passion for entrepreneurship, innovation, and community leadership.Headquartered in Rocky River, Ohio, Roundstone was founded in 2005 with a vision to deliver better healthcare outcomes at a more affordable cost. Over the past two decades, Roundstone has grown rapidly, creating nearly 200 jobs in Northeast Ohio. The company works closely with employers and benefits advisors to navigate the complexities of commercial health insurance and build custom plans that prioritize employee well-being over shareholder returns. By focusing on aligned incentives and better health outcomes, Roundstone is helping businesses save thousands in Per Employee Per Year healthcare costs. Roundstone Insurance — Built for entrepreneurs. Backed by innovation. Committed to Cleveland.Learn more at https://roundstoneinsurance.com/-----Stay up to date by signing up for Lay of The Land's weekly newsletter — sign up here: https://layoftheland.ck.page/5f0c1e28faConnect with Jeffrey Stern on LinkedIn — https://www.linkedin.com/in/jeffreypstern/Follow Lay of The Land on X @podlayofthelandhttps://www.jeffreys.page/

Life sciences are at a critical inflection point, where scientific innovation, regulatory demands, and patient expectations converge with advances in data and artificial intelligence, positioning IT as a central driver of faster and more effective drug discovery and clinical development.This week, Dave and Rob continue with part 3 off the Life Sciences mini-series with Predrag Angelovski, VP, CTO at Healthcare Informatics at Philips to exploring how MedTech products are more and more becoming connected platforms, combining hardware, software and services.TLDR00:21 – Introduction with co-host Thorsten Rall01:00 – Hang out: Esmee joins and Rob is lost at a train station03:00 – Dig in: Life Sciences mini-series, Part 304:57 – Conversation with Predrag Angelovski50:56 – Travelling to Europe, agents vs. agentic, and the age of intelligence GuestPredrag Angelovski: https://www.linkedin.com/in/predrag-angelovski/ HostsDave Chapman:  https://www.linkedin.com/in/chapmandr/Esmee van de Giessen:  https://www.linkedin.com/in/esmeevandegiessen/Rob Kernahan:  https://www.linkedin.com/in/rob-kernahan/ ProductionMarcel van der Burg:  https://www.linkedin.com/in/marcel-vd-burg/Dave Chapman:  https://www.linkedin.com/in/chapmandr/ SoundBen Corbett:  https://www.linkedin.com/in/ben-corbett-3b6a11135/Louis Corbett:   https://www.linkedin.com/in/louis-corbett-087250264/ 'Realities Remixed' is an original podcast from Capgemini

Are broad product claims slowing down your MedTech product's route to market without you even realising it?Many MedTech companies assume that regulatory delays mean they need more clinical evidence, more funding, or more time. But in many cases, the real issue is that their product claims are broader than the evidence they already have. In this episode, Hakeem unpacks Jordan Morrison's decision-making framework and explains why narrowing your claims could help you achieve regulatory approval, generate revenue sooner, and build momentum for future growth.Listeners will discover:Why regulatory hurdles aren't always the biggest obstacle to getting your MedTech product to marketHow to match your product claims to the evidence you already haveWhy securing one well-supported claim can accelerate commercialisation and create a platform for future expansionPlay this episode now to discover how a more focused regulatory strategy could help you get your MedTech product to market faster and build commercial momentum.This keeps the focus where your audience is: commercialising MedTech products, rather than getting lost in the technicalities of regulation.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.

Christy Brown has spent her career leading high-performing teams, driving strategy, and delivering results at the highest levels of medical technology. But nothing prepared her for the day her four-year-old son, Alexander, was diagnosed with an aggressive form of pediatric brain cancer. In this deeply personal conversation, Christy shares how one moment changed everything—her perspective on leadership, success, pressure, and what truly matters. She also sheds light on the heartbreaking reality of childhood cancer research, why pediatric cancer receives less than 5% of federal cancer funding, and how families can make a difference through awareness, advocacy, and action. This is a conversation every healthcare leader—and every parent—should hear.RESOURCES:AlexanderStrong.org

LearUp: Driving MedTech Innovation Through Digital Technologies

In this episode of Medsider Radio, we sat down with Aditya Rajagopal, co-founder and CEO of Esperto Medical.Esperto is a Caltech spin-out utilizing compressed sensing technology with ultrasound to continuously and non-invasively measure blood pressure.Before Esperto, Aditya co-founded ChromaCode, a molecular diagnostics company, and was a researcher at Google[x], where he worked on novel medical imaging methods. Aditya also serves as part-time faculty at Caltech and USC, and holds BS, MS, and PhD degrees in Electrical Engineering from Caltech. In this interview, Aditya discusses why great science doesn't necessarily make great companies, what it takes to win as a fast-follower in medtech, and how to sequence a platform technology without spreading resources too thin.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 Aditya Rajagopal, 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(02:44) - Aditya's journey from Caltech and Google to tackling one of medicine's hardest engineering problems at Esperto (05:17) - How Esperto is trying to solve a 50-year-old problem: continuous blood pressure monitoring without an arterial catheter (07:17) - Why Esperto was okay with being a fast-follower in an established market instead of creating a new one (16:12) - "Great science doesn't necessarily make great companies" and other lessons Aditya learned at ChromaCode (24:02) - Three hurdles every medical device must clear before clinicians will actually adopt it (27:44) - How Aditya determines whether a technical problem actually has a "there there" (37:51) - Esperto's pitch strategy and how it raised from a position of strength (43:18) - What first-time founders often misunderstand about how venture capital actually works

Allison Komiyama, a consultant and senior regulatory strategist at DuVal & Associates and founder of Bluestocking Health, shares her journey from neuroscience and an FDA reviewer role into regulatory affairs and consulting. Allison explains why companies should educate FDA about their device by telling a compelling, respectful story, and discusses why “getting through FDA” is often the starting line. She highlights the post-clearance work of launch, adoption, and promotion while staying within FDA marketing rules. Allison also reflects on leadership, relying on community and advisory boards, her volunteer work, and the moments that affirm her impact when devices reach patients.  Guest links: https://www.bluestocking.health/  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 083 - Allison Komiyama [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, Allison Komiyama. Allison is a consultant focused on getting medical devices to market and helping them stay there. She frequently presents at conferences, is an advisor at numerous technology incubators, and teaches students around the world about the regulatory submissions as a faculty member at SDSU Global Campus. She received her doctorate in neuroscience in 2009, was an FDA reviewer from 2010 to 2011, received her Regulatory Affairs Certification US in 2014, and became a RAPS Fellow in 2024. Throughout her career, she's been actively involved in hundreds of pre-submissions and pre-market submissions for a wide variety of medical device companies. She recently started a medical device hype company called Bluestocking Health, where she continues to elevate and amplify the message of exciting technologies entering the market. She's also a senior regulatory strategist at DuVal & Associates, where she helps companies navigate the FDA pre-market process. Alright, well, welcome to the show. I'm so glad you're here today. [00:01:59] Allison Komiyama: Thank you so much. I'm so glad to be here. [00:02:02] Lindsey Dinneen: Well, I've been looking forward to this conversation very much. I got to meet you, I think it was maybe last fall, and it was after watching a video where I believe you were chopping wood while explaining a medtech concept, I and was like, "I have to meet this person." [00:02:21] Allison Komiyama: I like that that is how we, we, yeah, that you were introduced to me is through a wood chopping video. But yes, that was me. I love... I am a lumberjill, so yeah. [00:02:31] Lindsey Dinneen: See? And we will get into this, let's start with just a little intro into who you are, your background, and what led you to medtech. [00:02:39] Allison Komiyama: Sure. So background's actually biology, neuroscience. Left academia after graduate school and went and worked at FDA. I was just there for a brief period of time, but it was very instrumental in having me understand what I wanted to do with my life. I knew I loved regulatory affairs. I knew that I loved med devices and the intersection of medtech and innovation and regulatory and, and, and, and, and, right? Like, so all the things I was just super excited to be part of this space. But after leaving FDA, sort of tried to figure out what... You know, did I wanna work at a company? Did I actually wanna be at a specific industry job? Tried that on. Tried that hat on for a little over a year at an IVD company and just sort of missed all the stuff I got to work on at FDA. So I kind of saw it as the second-best thing after FDA is to go into consulting. So really worked with a lot of startups and companies that were bringing their technologies to market, and yeah, never looked back. I did sort of change positions over the years from going from a small consulting company to my own consulting company to a large consulting company, and now I'm sort of back at a, a smaller regulatory law firm. It's not that small, but, you know, 15-some people at DuVal & Associates working with companies that need help with strategy and regulatory support as well. And also started my passion project, which is Bluestocking Health. It is a medtech hype company, is what I call us. And we really work on helping companies after they've made it through FDA onto what... you know, what does, what does their launch look like? How do they get people to adopt their technologies and not sort of flounder and, and fail, right? So I, I love seeing really cool, nerdy, geeky tech get to market, and I think we all have a sort of inner geek that loves stuff like that, and it's my happy place where I can just kind of talk about those things and share it with patients and caregivers alike. [00:04:47] Lindsey Dinneen: Amazing. I love that. Yeah, and so much to dive into. But one of the things also I remember, so so I, I watch this video and you're chopping wood, and you're, you're clearly super passionate about medtech. And then I think the next one, were you possibly like baking or doing some sort of maybe chopping? [00:05:08] Allison Komiyama: Yes. I do flower arranging, so it might've been that one. I, I-- That's a great idea, though. I love to bake. I love protocol, so I think you're onto something. I need to come up with a video maybe where I'm talking about, like, the de novo process and, like, baking a cake or something. So. [00:05:27] Lindsey Dinneen: Amazing. And you're right, it was flower arranging, and I was thinking at the time, "Is there anything you don't do?" [00:05:35] Allison Komiyama: Yes. I-- There's a lot of things I don't do or don't even dare to do. Mostly dangerous sports. I, I'm a rower, so I love to row where no one's touching you. You know, like no one... There's no physical contact. You're just in a boat pulling an oar, and it's quiet and peaceful and, you know, also you're working hard. So, but otherwise, yeah, don't want any contact sports in my life. And but there's a lot of things I don't do, of course. I just have a lot of hobbies and things that I enjoy doing. [00:06:10] Lindsey Dinneen: Okay. So did the idea for Bluestocking Health come from? I mean, I know you explained a little bit about what the company does and who it helps, but first of all, I'm really curious about the name, and second of all, I'm just curious about, yeah, what made you go, "Gosh, this is the right time for this"? [00:06:27] Allison Komiyama: Yeah, great question. I-- So Bluestockings were... I'll, I'll go first into the origin story 'cause I think it kind of helps explain why I picked up that name. The Bluestockings were a group of mostly women in the 1700s in England who were, you know, kind of tired of sitting around playing card games and, you know, learning new dance routines-- not that there's anything wrong with that-- I love doing all of those things. But they decided they wanted to pursue some more intellectual and intellectually stimulating conversations with people. So they would invite women and men into their salons to have these conversations, and they would talk about botany and, yeah, science, art, literature, theater, all of the things that sort of sparked their interest. And they would say, you know, "Don't worry about wearing your black stockings," which were, like, the highly fashionable, expensive stockings of the day. They said, "Just come in your blue stockings. It's fine." You know, which were wool and, you know, cheaper. And I was like, oh, I love that idea of just people getting together, talking about stuff that they find interesting, and having it be like, "Come as you are. Wear your sweats," you know? "Don't worry about getting fancy." And that resonated with me. And so I thought, you know, what I want to build is something similar to what the Bluestockings had, but have it be more medtech or health-focused, and so hence Bluestocking Health was born. I, yeah, I really... A-as I said earlier, I saw a lot of companies feel like getting through FDA was the finish line, and I s- you know, I would tell them, like, "No, that's kind of the starting line with a lot of what you're going to now need to build." You know? It's-- I, I think historically FDA was seen as, like, the hardest thing to get through, which isn't always the case, right? The, the 510K program is historically very successful with getting devices cleared. You know, FDA does wanna work with you, and that was my narrative and my mantra always was like, you know, "How do you work with FDA to get through FDA?" And then once you're through FDA, what's next? And I wanted to have those honest conversations, you know, as these companies were considering the product development, their quality system, their regulatory, and, you know, even reimbursement is also part of that post-market conversation. And I wanted them to also think about, "How are you gonna get patients to know about this? Like, what are ways that you can promote yourself and promote what you're doing without misbranding or mislabeling or adulterating anything, right?" You wanna stay within FDA's regulations and not do anything wrong marketing-wise. But it's also something to get really excited about, and I think we've often forgotten that a lot of these medtech devices do really, really cool things, do really amazing work to help people, help people s- you know, improve their quality of life. Let-- Help them survive, get them to live longer, let kids actually make it to adulthood, right? So there's so much good that I wanted to amplify that more. I wanted to get people to not just focus on the negative, right? There is, there is a lot of harm that can come from any sort of drug, device, anything, but there's also a lot of good. And so I think especially right now in the world we need more good things to talk about. Not that I wanna, you know, look at everything through rose-colored glasses. But I do think if we can focus on some of the good that's going on in the world and the things that we have in common, what a great conversation to have. [00:10:14] Lindsey Dinneen: Oh, yeah, I couldn't agree more. And I love the fact that and you're so much fun. You're helping these companies also get excited too, because I think sometimes it's really easy-- I mean, we need to take our industry seriously. It's a serious industry and real life consequences, good and bad, from innovation... [00:10:29] Allison Komiyama: Yes. [00:10:30] Lindsey Dinneen: ...But I think you know, we've, we've talked a lot about this recently, even ar- along amongst just some of my colleagues, is like we're gonna take, we're gonna take our actual work very seriously, of course, but we're gonna not take ourselves super seriously. We're gonna have fun. We're gonna celebrate. We're going to each other why we're here and why we're doing this, 'cause otherwise it can get easy to get kind of bogged down in the, the nitty-gritty. [00:10:52] Allison Komiyama: Oh, it's so easy to spiral. I-- And I feel like a lot of media allows us a-and, and capitalizes on that doom scroll/spiraling of, "Oh gosh, everything's bad." And I wanna be informed, but I also, as you said, I don't wanna take myself that seriously. Like, I have so many hobbies. I laugh a lot. I have really great conversations with people, and I think that's what I, you know... the legacy I wanna le- leave behind is that I made the world a little better than when I started here. And also that I had a lot of joy to share. So yeah. [00:11:31] Lindsey Dinneen: Okay. So I-I'm curious, going back to your days at the FDA, what are some of the common things that you saw where perhaps there's either a misconception about the process of approval or just mistakes you might have seen that were kind of common that maybe those who are listening who are trying to, you know, get through it as, as easily as possible could benefit from? [00:11:54] Allison Komiyama: I think one of the biggest misconceptions and it wasn't anyone's fault, was that FDA are the experts in what you're building. And maybe, maybe folks knew that that wasn't the case. You know, they walk in and they know that they're living and breathing their technology and their device day in and day out. They've been building it for years oftentimes. And so to think that FDA understands your patient population, understands the, the sensor technology or whatever technology you're building understands your software, your materials, all, all the various things that go into a s- a pre-market submission, is a terrible assumption to make, right? Not that you wanna treat FDA like a bunch of dummies, that you're like, "Oh, you guys don't know anything. I'm gonna have to start from, you know, square one here to really walk you through everything." But you definitely want to communicate and be able to tell a really solid story to FDA about what you're building or what you've built, and why you believe it's either safe and effective, or why you believe it's substantially equivalent, or why you believe the benefits outweigh the risks. And so I think if you can be that storyteller, if you can really walk FDA through what it is you've built, and why you think it should be, you know, allowed to enter interstate commerce, you've w- you know, you, you're already ahead of the game. So I think any company that really is trying to figure out what's that first interaction they're gonna have with FDA, whether it be at a pre-submission or just straight to pre-market submission, right? They're just gonna file the, the, the 510K or what have you. Really making sure that you've explained your product and they know why you're there. Otherwise, you are going to cause more questions than answers from FDA, and that's a big concern when you have somebody who doesn't understand what you're doing or why you've built it the way you've built it. That can really set you back. [00:13:56] Lindsey Dinneen: That's great advice. So, so being really prepared to kindly educate while telling the story, but you know, doing so, of course, in a, like you said, a respectful way. But, but having those answers ready, having the narrative really thought out so that you can walk in with that authority, but also explanation and storytelling. Yeah. Okay. [00:14:19] Allison Komiyama: Exactly. Yeah. It is. I mean, I always my-- I've actually, I have a podcast that I f- a few of my guests recently, they've all been expert or experts in how we tell stories, which I love even just... I mean, how we tell stories to our children is very different to how you tell a story to a colleague at work or, you know, the... and there's a way that, once you know your audience and once you know what it is you're trying to convey, there's a very clean path that you can follow. I'm still working on it. I have to, I have to confess, I am not a great storyteller. I have a tendency to get sidetracked and off topic, probably like what I'm doing right now. But, but you know, bringing it back and, like, what are, what are we trying to do? What are we trying to accomplish? And that I think that storytelling is really valuable when you have FDA as your audience. [00:15:15] Lindsey Dinneen: So I know, like you said, you have many hobbies and lots of things that keep you occupied, but you also do a lot of volunteering for boards. And I was wondering if you could share just a little bit about some of that experience and what you're passionate about there. [00:15:29] Allison Komiyama: Yeah. I think I've always been a big fan of volunteering. I think it's one of the ways that I I meet new people, I get involved in s- things that are outside medtech, which I think is extremely valuable. There's so many voices that even if it's not directly in medtech, everyone's impacted by medtech in some way, right? Like I always say, "You're either gonna start in a hospital or end in a hospital, and you're probably gonna go into a hospital at many different times or use a medical device, whether it be on your phone or, well, while you sleep or," you know, for any-- I don't know, there's a million purposes that people use medical devices. And I wanted to have more voices around me that that are, that are helping humanity, but in a different way. So, one of the boards that's always been near and dear to my heart, of course, my rowing club. I love... It's the oldest women's rowing club in the world. It's called Slack Rowing Club, based here in San Diego, and I help with a lot of the programs, but also fundraising, membership, and just, you know, having this really dynamic group of 400 women that some of them row, some of them are just there to be part of a community and help each other, which is pretty marvelous. And we do a lot of actually talks. Like we'll have a speaker series and we'll bring in physicians or we'll bring in people who are talking about sleep and perimenopause and menopause or, you know, various topics that definitely impact our our cohort. It, it's actually kind of similar to Bluestockings, like the original Bluestockings, where we'll have someone come in and talk about architecture. Like there's various things. So I love doing that. It's also-- They're-- The members are from like 12 years old to 102 years old. It's pretty amazing, and just, like, this great dynamic group of women who are fun to volunteer with and also sit in a boat with. The other one that I've joined last year was the International Relief Teams, which works on helping bring some sort of relief to an emergency situation, whether it be floods or fires or famine or war. Like, there's, They partner-- We partner with different organizations that are, like, boots on the ground in those areas to either build houses or get m- meals or get water to where it needs to be in an emergency. So IRT is fantastic. They get, like, one of the highest ratings of nonprofits. The other one is Indy Medtech. Really cool. That's a very medtech-based one. It's a virtual board, but it is building a community of medtech suppliers and people who are just needing support from each other or you know, either hiring or, "Hey, I have a question. Can someone help answer this 'cause I don't know where to go to get the answer to this?" So really cool, and they, they're doing a podcast as well. I love it. And then last but not least is the San Diego Regulatory Affairs Network. So I have been in San Diego, moved here back here, I should -- i'm from San Diego-- but moved back here in 2011, 2012, and I joined the San Diego Regulatory Affairs Network. It's the SoCal... Like, there's a similar one in Orange County, the Orange County Regulatory Affairs, so OCRA, and then there's also, of course, RAPS, and there's a Southern California chapter. And it's just a group of regulatory folks that love to meet up, love to support each other. "Hey, I have this job opening coming up. Hey is there a mentee that would like a mentor?" And so I'm now the VP of programs for that, and once a month we try to have a speaker either virtually or in person. There's gonna be some in-person ones. And I love it. It's just a great way to network, to support each other, and also to learn more cool stuff going on in regulatory. So yeah, that's a smattering of the ones that I'm part of. So, you know, as, as you said, like, it's kind of like they're all over the place, but it definitely makes me feel more connected with humans, with our-- you know, like, and, and not doomscroll. I'm, I'm too busy to doomscroll. So. [00:19:44] Lindsey Dinneen: That's, that's a good thing, I feel like. So, I love that. Okay. Those are g- those are such cool organizations. Thank you for sharing a bit about them. [00:19:51] Allison Komiyama: Yeah. Thanks for asking. [00:19:52] Lindsey Dinneen: Yeah. So all right, I'm curious. Going back, could eight-year-old Allison have ever imagined what you're doing now? [00:20:02] Allison Komiyama: Never in a million years. Yeah, I think I, I knew I loved biology and bugs and science at a very young age, so I knew that I was probably on that trajectory. But if you asked eight-year-old-- or actually, I-- if you asked five-year-old Alison what she wanted to be, the first was hummingbird, and I did... That did not pan out. [00:20:29] Lindsey Dinneen: Dang it. [00:20:29] Allison Komiyama: But and then I would say florist 'cause I love flower arranging, so that is something that I've s- I've kept up with, as you said, like you saw the video of me arranging flowers. I still love doing that. I, I enjoy that creative outlet. But not in regulatory. I didn't really know that regulatory affairs existed as a career especially until I was 26. I mean, which is crazy to think, like I was in grad school, and I took a course on the history of FDA, and I was like, "What is this? This is so exciting, so interesting." And I knew that was something, that something along those lines is what I wanted to do with using my biology and, and neuroscience background, but also how do I maybe get closer to medicine in a certain way? Like, I, I didn't wanna be a medical doctor, but I knew I wanted to help people. Like, I think most people wanna help people. And that was, that was the right pivot for me at that point. [00:21:32] Lindsey Dinneen: Amazing. So, all right. So you've had a bunch of different leadership positions now over the years. And of course, you have led your own company now a couple different iterations, I suppose, of, of what you've been doing. But what has that leadership journey been like for you, especially perhaps how different it is between working for another company where you might be in a leadership role versus leading yourself and your company? [00:21:56] Allison Komiyama: Great question. I-- what was it, what's it been like? I would say there's like equal parts fearlessness, excitement, and terror. I don't know, like I-- maybe those are all kind of, of the same like ilk of those, those feelings. My daughter always says, she's like, "I'm nervous and I'm excited," like before she goes on stage in the talent show, and she's like, "I'm nerve-cited." And I, I, I use that a lot now too 'cause, you know, before I give a talk or before I you know, go on a podcast like this, I'm like, "I'm nerve-cited," 'cause it's gonna be something that I haven't done before, right? Every day is a little different and... But it's also exciting to do. I Yeah. I, I feel like it was not always easy. Like, people are like, "Oh, you made it look so easy and, and just, you know, seamless." And oof, there were moments that I really struggled. It's... You know, there have been times that I really relied on my family, on therapy, on my friends to really help me. And even just, you know, something as simple as I had a friend who made my first website for me. He was like, "You're so busy and stressed," like, "Let me help you." And so I think calling on others and really having people be your community that you've built, right? Like, I think sometimes we try and go it alone, and maybe that's the worst thing to do when you're building something 'cause you really need to rely on others to help you out. And so I've had, you know, I've, I've, I've worked really hard on my network and to build the friends and colleagues that I want to surround myself with, and then I have reached out to them when I knew I need them. So I, for example, I think with Bluestocking Health, I... When I was-- Before I launched in last year, so September of 2025, I called a bunch of folks that I really trusted to tell me if I was going off course or to also help me build stuff. And my advisory board for Bluestocking Health is amazing. Like, they're not all in regulatory, 'cause that's not what I wanted to build. They're in media. They're in quality system, reimbursement, business strategy. Like, there's such a diverse group of folks that will also help be my sounding board, right? Like, I had a couple medical doctors that I reached out to that are on the advisory board that I was like, "I'm thinking of doing this. Can you give me, like, your thoughts pro/con?" And they always are so willing to help, right, if they have the time. It's been extremely rewarding. So I would say that leadership journey, again, not the easiest at times, but also when it gets hard calling on those friends to really support me has been really marvelous. [00:24:49] Lindsey Dinneen: Yeah. You know, that's such an interesting thing because this has come up a lot, especially in the last few episodes and just conversations I've had in the industry of the importance of community and mentorship and surrounding yourself with those good people who you can call and go, "Okay, I have this, I have this, I think maybe crazy idea. What do you think?" Or just, "Hey, life is a little tough right now. Can we just, can we just talk?" So that's... [00:25:15] Allison Komiyama: Yeah. [00:25:15] Lindsey Dinneen: ...Really cool. [00:25:17] Allison Komiyama: Yeah. Absolutely [00:25:19] Lindsey Dinneen: Yeah. Okay. So as you've gone through your career, and especially within the medtech industry, which seems like you've really just, you know, fell in love with and, and stayed, so that's wonderful. Are there any moments that stand out to you as really affirming that, "Yes, I am in the right place at the right time"? [00:25:40] Allison Komiyama: I think every clearance De Novo granting that I've ever been part of, even if my name's not on the file, has been one of those moments where, oh, it feels so good. It feels so great to see those companies make it through FDA. And then also, you know, to the next point or d- you know once they are selling and they're, they're helping patients, I've had clients reach out to me and say, "I just got this amazing testimonial from somebody and I wanted to share it with you because you were part of that journey." And oftentimes I'll say, "Can I share that with the FDA reviewer that helped us 'cause they're still there and I really think that they would value that, that piece of information, just that commentary and that validation." I mean, w- I've had ones where the testimonial was like, "Because of this device, my kid is alive today. My kid would have been-- would have died two years ago if it hadn't been for this product." And like, I even just got chills. Like I-- honestly, it feels like even though I'm not a medical doctor, even though I was, you know, integral maybe in putting their 510K together or their submission together, and I've never touched the device necessarily, I feel so rewarded that it's like, we did it. We did it together, right? And I, I wanna share that with others. I think that's part of what I'm trying to do with Bluestocking Health is like we all are part of this community, and it's not that we just like clock in and we, you know, do document control or, you know, work on our risk assessments and, you know, clock out for the day. It's like, no, we, we do all help save lives, right? What a, what a powerful thing to be part of and to know that that's, that's something that you helped do. I don't know. I, I-- maybe that sounds again a little too like look how great we are. Like how, you know, look at, look at how amazing this space is, but oh, it is. It 100% is, so. [00:27:43] Lindsey Dinneen: No, I could not agree with you more. I've, I've always felt the same way of just like, "Okay, I'm, I'm not the scientist, I'm not the engineer, I'm not the regulatory affairs person. I, you know, I play a very small role. I, I help talk about the devices." I sh- you know, the marketing... [00:27:59] Allison Komiyama: Yes. [00:28:00] Lindsey Dinneen: ...And that's, you know, that's, that's not the biggest component of bringing these devices to market by any stretch of the imagination. But I do get to play a role, and I think that is the coolest thing ever. Yeah. [00:28:12] Allison Komiyama: Yeah. Well, and think of-- I mean, I'm gonna be your hype woman for a second because think of all the people who learn about that tech or understand, "Hey, this might be something right for me or my loved one, and if I hadn't learned about it or if I hadn't you know, been exposed to this idea or even knowing that this is in clinical trials, okay, now I'm gonna go look into the clinical trial." Like, that information sharing and even just talking to people or talking to laypeople, like, there's such an important piece of the marketing and the strategy around that, that it's huge. I-- you know, like, directly or indirectly, you've saved a life, right? How cool is that? [00:28:56] Lindsey Dinneen: Yeah, exactly. How cool is that? It's, it's remarkable. Okay. So, all right. Pivoting the conversation a little bit just for fun. Imagine that you were to be offered a million dollars to teach a master class on anything you want. [00:29:09] Allison Komiyama: Ooh, yes. [00:29:10] Lindsey Dinneen: What would you choose? [00:29:10] Allison Komiyama: I mean, all of the things in my header, I think at LinkedIn. So I lo- but I'll, I'll give you a real answer in a second. I think, I mean, all of the... I love my creative outlets. So I love flower arranging, I love face painting, I love chopping wood. I love cross-stitch and needlepoint, and my daughter and I just started doing crocheting together. So I feel all of those things are so I... Not that I'm a master in any of those things, but maybe it's being willing to try new things or having that, I don't feel, I don't consider myself to be a totally fearless person, but maybe channeling some of that fearlessness and a willingness to try new things, and where do we find that and how do we kinda overcome some of that activation energy sometimes to get to try those new things? And I think innovators have that in spades, right? So a lot of the companies that we work with, they're like, "I have an idea, and I don't know if this is gonna work, but I'm gonna go for it." And I think a lot of those cre- it, it's a creative outlet for them as well, right? They're trying something new. And so maybe it's giving people more more support or more confidence that they can try new things. I feel like I don't love change. Like I, I, as a child, I like, I liked the things that just stay the same. But when you look at my arc and my, my origin story, it has been all about very unsettling moments or, you know, like where I was felt, feeling very unsettled or like trying something new, and I'm so grateful for all of those things, and I'm also really grateful that I did it, right? So a- and again, it came down to a lot of my community, my friends, my family that supported me and said, "Yeah, you can do this," right? Having those hype people to help me. So maybe a masterclass in just like being the hype person for people who wanna try new things and try leadership, right? Or try a new path that they hadn't thought about yet. [00:31:24] Lindsey Dinneen: Like, I think to your point too, the more that you're willing to do that and kind of step a little bit outside of your comfort zone and have that potential for quote unquote "failure." But, you know, first of all, the more you do that, the more resilient you get, which means it's easier and easier and easier to take those first steps, right, into something new. [00:31:43] Allison Komiyama: Yes. [00:31:44] Lindsey Dinneen: But I also think-- I, I often think about it in terms of if you can frame those kinds of moments as "I am exploring, this is an exploration" and not like pass-fail, if you're exploring, there's, there's no chance of failure, right? You can, you can explore something and go, "Ugh, not for me," or you can go, "Oh, I actually love this, but it's hard and I'm gonna have to keep working at it." But I think if you can like kind of maybe take it in a slightly different mental direction, that also helps, you know? [00:32:13] Allison Komiyama: Ooh, I like that. Yeah. Like reframing. This is not, this is not something that's gonna, you know, end in failure, 'cause I agree with you. You know, I've called it failure in the past where it's like, "I'm gonna try things. If this fails, then I'll go do something else," right, which then it's not really a failure. You learned something. But it is being able to change directions. It is the ability to say, "Okay, I figured out that I something from that, and then what am I, what am I gonna do with that information?" So I love that. [00:32:48] Lindsey Dinneen: Oh, that'll be a masterclass. I can't wait. okay. And how do you wish to be remembered after you leave this world? [00:32:55] Allison Komiyama: Oof. I hope I... It's, oof. I, I, I hope to be remembered. Yeah. What does my dash look like? Isn't that what they say? Like, what is the dash between the, the birth year and your the year of your death? I definitely wanna be remembered for, like, what my kids are doing, 'cause I'm pretty proud of, like, how badass both of those girls are. But back to your question. I would like to be remembered as somebody who helped innovators and people who were building in the medtech space to grow their brand, to get their message out there, and to really bring awareness to the benefits of medtech. I think it's so easy, as I said earlier, it's very easy for us to get caught up in the bad and the negative, and here are the risks, and we really are so nervous about the risks of things, as we should be. We should be a res- risk-averse population. Like, they-- I don't wanna be walking towards something that's gonna cause me harm. And at the same time, there's a lot of benefit to what we're doing, and I think if we can I guess what we were just talking about, reframe a little bit and say, "Yes, there's risk. There's inevitable things that are gonna happen, but here's the potential benefit," and how do we h- in a human way, weigh those things so that we can get other people to also see that this is something that could benefit them. So it's sharing that message. I wanna know, be, you know, considered somebody who also didn't take herself too seriously, made people laugh. You know, maybe they showed their, their kid a, a video of me doing something silly, but also maybe there's some kid out there that's like, "Oh, she was talking about regulatory affairs. What's that? Maybe I should look into that as a career option." So, yeah, I hope some of it is inspiring to others. [00:34:48] Lindsey Dinneen: Okay. That's, that's great. And then final question: What's one thing that makes you smile every time you see or think about it? [00:34:59] Allison Komiyama: I wanna say my kids, but really it's probably hummingbirds. I have never lost the total fascination with hummingbirds. They are so interesting. They're so beautiful. There's a lot of them here in San Diego where I live, and I kid you not, last year, a mother hummingbird built her nest right outside of our front door. And so we'd have-- we told our guests, like, "Come through the, the side gate 'cause do not walk close to, to our sweet hummingbird." And she laid two eggs, and I was able to watch these two little hummingbirds grow and fledge. And I... It was just one of-- again, it makes me smile every time I think about it. Every time I see a hummingbird, I'm like, "That might be our girl that, that had, that had her nest right here." So yeah, I think that whimsy, the, the, the fun and just how gorgeous they are. They always bring... sparks me joy, for sure. [00:35:58] Lindsey Dinneen: Absolutely. Me too. I adore hummingbirds. One of my favorites. Yeah, love that. Oh my goodness. Well, this has been an amazing conversation. Allison, thank you so much for taking time today to speak with me, 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. Oh my gosh, and just thank you so much for everything you're doing to change lives for a better world. We're grateful for you. [00:36:42] Allison Komiyama: Thank you. It's so nice to be here. Thank you so much for having me on. [00:36:45] Lindsey Dinneen: Absolutely. Until next time. [00:36:49] 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.

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.

Glenn Hunzinger, PwC's US Health Industries Leader, speaks with James Woods, PwC's US MedTech Leader, about the forces shaping MedTech dealmaking in 2026. Despite capital market pressures, supply chain challenges, and geopolitical uncertainty, companies continue to invest in innovation, portfolio transformation, and growth opportunities. The conversation explores where capital is flowing, how companies are reshaping portfolios, and what dealmakers should watch in the months ahead.Discussion highlights:Continued MedTech deal activity despite capital market pressures and economic uncertaintyInvestment focused on cardiovascular technologies, robotics, connected care, and ecosystem-enabling solutionsPortfolio transformation as a driver of growth, shareholder value, and strategic repositioningConnected care's role in improving efficiency, patient outcomes, and healthcare deliveryPrivate equity activity across take-private transactions and portfolio carve-outsStrategic priorities for MedTech leaders balancing organic growth, M&A, and capital allocationSpeakers:Glenn Hunzinger, US Health Industries Leader, PwCJames Woods, US MedTech Deals Leader, PwCFor additional insights on the medtech deals landscape, check out our Medtech: US Deals 2026 midyear outlook https://www.pwc.com/us/en/industries/health-industries/library/medtech-deals-outlook.htmlFor more information, please visit us at: https://www.pwc.com/us/en/industries/health-industries/health-research-institute/next-in-health-podcast.html.

Suspect in custody following fatal shooting in Morrilton; Victim ID'd in Hector homicide; Med-Tech adding to fleet amid high call volume; SCCSD reports improved K-2 ATLAS scores; Local project to benefit from AARP Community Challenge grant; Boozman introduces "Farm Bill 2.0"; AAA dead period underway; Jerry Smith with the Conway Co. Bicentennial Committee discusses County Roadshow Kickoff

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

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.

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.

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.