Podcasts about Medtech

Your medical device has regulatory approval, clinical evidence and manufacturing in place but does that actually mean customers are ready to buy it?This doesn't diagnose their problem. It challenges the assumption that the three green ticks automatically equal commercial readiness.A MedTech product can be completely ready to launch and still not be commercially ready to sell. Before spending heavily on salespeople, distributors, exhibitions or new export markets, you need to know whether customers have genuine demand, how your medical device actually gets bought, and what could make adoption harder than expected. In this episode, Hakeem explains how to assess your commercial readiness before scaling a go-to-market strategy that may not yet work.In this episode you'll discover:How to distinguish genuine customer demand from positive feedback and interest before investing heavily in commercialisation.Why understanding the complete buying pathway—from clinicians and other decision-makers to evidence, procurement and budgets—is critical to turning interest into revenue.How to identify adoption friction and stress-test your go-to-market model before adding more salespeople, distributors or export markets.Listen now to discover whether your MedTech product is genuinely ready to sell—and what you need to fix before investing more money in commercialisation, adoption and international growth.Message me via DM on LinkedinTake the CPI Quiz to see how commercially ready your product isThis podcast is for clinicians feeling stuck in turning medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, and to scale up their international sales in MedTech.

What if quality management could be the key to driving medtech innovation, not holding it back? In this episode, Ashkon Rasooli, Founder and Principal of EnGenius Solutions Consulting, breaks down how medtech companies can build quality systems that go beyond compliance to support innovation, efficiency, and long-term growth. The conversation dives into the challenges of keeping quality and regulatory strategies ahead of rapidly evolving technologies like software, cloud platforms, and AI, while exploring how companies can avoid costly mistakes, scale effectively, and prepare for the complexities of entering the U.S. market.Ashkon Rasooli LinkedInEnGenius Solutions LLC LinkedIn "Never Split The Difference" by Chris Voss "Million Dollar Consulting Toolkit" by Alan Weiss Duane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.

If you had £500,000 to enter the US with your MedTech product, where would you spend it first?For clinician founders looking to export a medical device to the US, the size of the opportunity can make it tempting to think big from day one. But entering the US MedTech market and scaling across it are two very different decisions. In this episode, Hakeem and international growth and commercialisation consultant Craig T. Ingram explore whether you should build a US sales team, appoint a distributor, raise more capital or prove your commercial model in one defined market segment first. In this episode you'll discover:Why treating the US as one enormous MedTech market can lead to expensive commercial and export decisions.How proving your commercial model in one defined US customer segment can help you understand acquisition costs, adoption pathways and whether your product can actually make money before you scale. Why hiring a sales team, appointing a distributor or raising more capital shouldn't substitute for first understanding exactly where, how and why your medical device will sell in the US. Listen now to discover how to approach US MedTech market entry, prove your commercial model and make your export budget work harder before committing significant capital to scaling.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.

Howie Chan is an influence strategist, branding expert, and marketing consultant who specializes in the psychology behind human decision-making. After losing a $10 million pitch early in his career, Howie became obsessed with understanding the invisible forces that shape behavior, communication, leadership, storytelling, and negotiation. Today, he helps MedTech companies and professionals build stronger brands and attract better opportunities by applying behavioral science and influence psychology. On this episode we talk about: The $10 million pitch Howie lost and how it sparked his obsession with influence psychology How getting laid off after 20 years in the corporate world pushed Howie into entrepreneurship Why experts should use LinkedIn to build a professional brand and attract opportunities The difference between a personal brand and a professional brand—and why solving problems matters more than follower counts How podcasts, strategic associations, and social proof can build trust and accelerate your influence Top 3 Takeaways Turn failure into a learning opportunity. Instead of dwelling on a loss, ask, “What do I not know?” and figure out what you can learn to prevent the same mistake from happening again. Make your professional brand clear, not clever. Your LinkedIn profile should immediately communicate who you help and what problems you solve. Focus on the quality of opportunities you attract rather than vanity metrics like follower counts. Build influence through a flywheel of visibility, trust, and association. People first need to notice you, then remember you, trust you, and ultimately choose or recommend you. Podcasting can accelerate that process by allowing you to consistently demonstrate expertise and associate your brand with respected experts. Notable Quotes “There are a lot of hidden things that we don't know about. We think we know, but we don't, that's influencing decision making every single day.” “Make it clear. Not clever.” “Every transaction moves at the speed of trust.” Connect with Howie Chan: LinkedIn: Howie Chan Website: https://www.howiechan.com/ Other: Expert Influence Quiz — Take Howie's free quiz to identify gaps in your influence flywheel. Podcast: Influence Anyone A Word from Our Sponsors: - The most successful business owners don't do it all themselves — they delegate. Upwork lets you build a team of highly skilled specialists for every function your business needs, so you can focus on what you do best and let experts handle the rest. Visit Upwork.com right now and post your job for free! - Go to Leesa.com for 30% OFF select mattresses (through September 13, 2026) PLUS get an extra $50 off with promo code TMM, exclusive for my listeners Learn more about your ad choices. Visit megaphone.fm/adchoices

What if spending more money on sales isn't actually the fastest way to grow your MedTech business?For clinician founders looking to commercialise and export a medical device internationally, growing a MedTech business takes more than regulatory approval, investment and an expensive sales team. If the market doesn't understand the problem your product solves or have a reason to change, adding salespeople can simply increase your burn rate without increasing adoption. In this episode, Hakeem speaks with international growth and commercialisation consultant Craig T. Ingram about creating demand before launch, entering new export markets and building a commercial model capable of sustainable international growth.By listening you'll discover:Why MedTech commercialisation needs to start long before regulatory approval and product launch.Why spending heavily on salespeople isn't the same as building a market—and what needs to happen first to create demand.Why proving your commercial model, controlling your burn rate and executing consistently can be more important than trying to scale quickly.ActionListen now to discover how to grow your MedTech business by creating demand first, spending your commercial resources more intelligently and building a model that can scale sustainably.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.

Cambridge Tech Week's pitch competition is back, and this year's shortlist might be the strongest yet. James and Faye sit down with four of the five finalists ahead of their head-to-head on the main stage of the Cambridge Corn Exchange on 16 September 2026. It's a special, quick episode, a reunion of sorts: four of the five companies have featured on the podcast before, many as #21toWatch winners. The fifth - an Edinburgh-based AI company - proves that Cambridge Tech Week's reach now stretches well beyond the city.This episode introduces the finalists:Phil Spence, HotHouse Therapeutics (Norwich) - engineering plants to produce entirely new-to-nature vaccine adjuvants. Their target? Replacing QS-21 - with a scalable, less toxic, bioengineered alternative of similar efficacy.Dr Monica Saavedra's, Lambda agri (Cambridge) - an additive embedded into greenhouse paint and polytunnel sheeting that converts damaging UV light into red light, boosting photosynthesis and delivering up to 20% more yield per crop.Sam Kamali, Myonerv (Cambridge) not present on recording - a wearable medical device, to monitor and treat stroke induced paralysis, allowing stroke patients suffering from upper limb paralysis, to regain real-time control of their hand.Ruben Ruiz-Mateos Serrano, Polytecks (Cambridge) - a novel conducting polymer woven into e-textile electrode arrays that map the body's electrical activity in high-density detail - their first product, stages the most common cardiac disease in dogs.George Arden, Xplore Intelligence (Edinburgh) - simulates real operational environments to train and benchmark entire AI agent systems - catching hallucinations and errors before they reach users in regulated sectors like MedTech and logistics.Why Are They Competing?The answer is consistent across all finalists: it's not just about the prize money.Fundraising momentum - multiple founders are mid-round and treating the stage as a high-quality investor touchpointEcosystem reach - Cambridge Tech Week draws a global audience; and creates a deliberate bridge across the UK deep tech communityThe live final is sponsored by Mills & Reeve, and joined by PwC, and Julius & Clark. Judging on the day: Zickie Lim (Partner & Head of VC & Investments, Mills & Reeve), Marilena Ioannidou (British Business Bank), Richard Lewis (Foresight Group), and Emmi Nicholl (Cambridge Angels).Two prizes are up for grabs: Judges' Award and People's Choice Award.Be there in person: Wednesday 16 September, Cambridge Corn Exchange. Tickets at cambridgetechweek.co.uk Subscribe on all major podcast platforms or visit cambridgetechpodcast.com.Headline sponsor Holden PolestarProduced by Cambridge TV#CamTechPod Hosted on Acast. See acast.com/privacy for more information.

Send us Fan MailMichael Brooks is the founder and CEO of BayCath Medical, a Silicon Valley medical-device company specializing in the design, development, and contract manufacturing of catheter-based products. BayCath was created to give startups and fast-moving R&D teams a more collaborative manufacturing partner—one capable of supporting rapid prototyping, iterative development, pilot production, and smoother transfers into manufacturing. Michael launched BayCath after seeing catheter development lead times grow and watching delays interfere with customer timelines. His vision is to create an environment where engineers, physicians, and manufacturing specialists can work closely together, explore multiple solutions, and make informed design decisions without wasting valuable time or capital. Before becoming a founder, Michael held program management, engineering, and manufacturing roles throughout the medical-device industry. Across those positions, he gained experience in braided and coiled catheters, material selection, process development, design for manufacturing, validation, manufacturing transfers, fixture development, supplier management, and regulatory support. He also led high-priority customer programs, helped establish project-management processes, and coordinated complex work across technical, operational, and customer-facing teams. Michael earned his bachelor's degree in biomedical engineering from the University of California, Davis, along with a minor in technology management. His career has placed him at the intersection of hands-on engineering, customer communication, program leadership, and entrepreneurship—giving him a valuable perspective on what it takes to move medical-device ideas from early prototypes toward production and, ultimately, patient care.  LINKS: Michael Brooks LinkedIn: https://www.linkedin.com/in/micbrooks10/ BayCath Website: https://www.baycath.com/ Innovation Week: https://www.baycath.com/workshops MedTech Bay Area Networking LinkedIn: https://www.linkedin.com/company/medtech-bay-area/  Aaron Moncur, host PDX 2026 is October 20-21 in Phoenix, AZ.  Learn more and register at https://pdexpo.engineer/  Subscribe to the show to get notified so you don't miss new episodes every Friday.The Being An Engineer podcast is brought to you by Pipeline Design & Engineering. Pipeline partners with medical & other device engineering teams who need turnkey equipment like cycle test machines, custom test fixtures, automation equipment, assembly jigs, inspection stations and more. You can find us at www.teampipeline.usWatch the show on YouTube: www.youtube.com/@TeamPipelineus 

Thinking about exporting your MedTech product to the GCC? Are you actually ready to build a market there or are you simply looking for a distributor?Successfully exporting a MedTech product to the GCC takes more than appointing a distributor and waiting for sales. You need clear clinical value, the right commercial partner, a plan for creating demand, meaningful measures of early progress, and ongoing manufacturer support. In this episode, Hakeem shares five key lessons from his conversation with experienced GCC distributor Sameh Salama to help you prepare for commercialisation, adoption and sustainable sales across the region.Listen to discover:Why strong clinical value and evidence need to come before approaching GCC distributors.How to choose the right distributor, create demand and measure the activities that lead to adoption and sales.Why successful MedTech export requires ongoing manufacturer support rather than expecting your distributor to build the market alone.ActionListen now to discover the five things you need to get right before exporting your MedTech product to the GCC and give yourself a stronger foundation for adoption and sustainable sales.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.

If a great export distributor had four MedTech products to choose from today, why would they choose yours?MedTech manufacturers spend a lot of time asking whether a distributor is capable of selling their product. But there's another question that's just as important: why should a good distributor choose you? Taking on your product means investing their sales time, clinical resources, customer relationships, marketing activity and reputation. In this episode, Hakeem unpacks a real decision with experienced GCC distributor Sameh Salama to reveal what good export distributors actually look for before deciding whether a MedTech product represents a genuine commercial opportunity. Listen to this episode to discover:Why strong clinical evidence matters to export distributors but isn't enough on its own to create a compelling commercial opportunity.What good distributors assess before agreeing to represent your MedTech product—and why a distributor who challenges you can actually be a very positive sign.Why successful MedTech commercialisation and export depends on the manufacturer and distributor working together to create demand, rather than expecting the distributor to build the market alone. Listen now to discover what good export distributors really look for and how to make your MedTech product a commercial opportunity they'll want to invest their time, resources and relationships in.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, Joe Tumolo shares why the best medtech companies don't just build innovative products; they build relationships that drive commercialization. Drawing on more than 25 years in healthcare and life sciences, Joe reveals how founders can strengthen fundraising, hire the right sales team, navigate healthcare adoption, and create commercialization strategies that lead to lasting success. Discover why aligning with customers, investors, and partners may be the most valuable competitive advantage a startup can have.Joe Tumolo LinkedInJTSC, LLC LinkedInJTSC, LLC Website“Thinking Fast and Slow” by Daniel Kahneman Revisionist History Podcast with Malcolm Gladwell “The Undoing Project” by Michael Lewis Duane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.

Thinking about exporting your MedTech product to the GCC? What if finding a great distributor is only the beginning of what you need to succeed?The GCC can be an attractive export market for MedTech companies, but you can't simply take the strategy that worked in the UK, Europe or US, appoint a distributor and expect the same results. In this episode, Hakeem speaks with GCC MedTech distributor Sameh Salama about what manufacturers need to understand before entering the region, from choosing the right commercial partner and navigating local purchasing dynamics to clinical education, KOL engagement and supporting your distributor after launch. By listening you'll discover:Why the GCC isn't one MedTech market and what manufacturers need to understand before choosing where and how to enter. How to choose a distributor with the right portfolio, relationships and capacity to successfully commercialise your MedTech product. Why successful MedTech export requires an ongoing partnership between manufacturer and distributor, including clinical education, training, market development and clear activity plans that lead to sales. Listen now to learn how to commercialise and export your MedTech product successfully in the GCC by choosing the right partner, supporting them effectively and building the market for long-term adoption and growth.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.

Dr. Austin Chiang has built one of medicine's most distinctive public platforms. He is a triple board-certified gastroenterologist, Chief Medical Officer for Medtronic's Endoscopy business and Associate Professor of Medicine at Thomas Jefferson University. He is also one of healthcare's most influential physician voices online, with hundreds of thousands of followers across TikTok, Instagram, YouTube and LinkedIn. That makes him an ideal guest for Season 11 of Fixing Healthcare with cohosts Dr. Robert Pearl and Jeremy Corr. This season asks what patients, clinicians and healthcare leaders are saying now that feels meaningfully different from the past. Chiang hears those concerns from several vantage points: as a practicing physician, medical technology leader, educator and public-facing doctor. For Chiang, three issues stand out: Clinician burnout and loss of autonomy Chiang says physicians are struggling with administrative burden, documentation demands, prior authorization, staffing shortages, reimbursement pressure and a growing sense that medical decisions are no longer fully in their hands. Pearl pushes further, asking whether clinicians must take more responsibility for affordability rather than simply objecting to the oversight created in response to rising costs. Chiang agrees that physicians need a better understanding of the broader healthcare ecosystem if they want to help change it. Medical misinformation and social media Chiang has spent more than a decade learning how to communicate across platforms and audiences. He explains that accurate medical information must now compete with sensationalized claims from people who are not held to the same professional standards as clinicians. For doctors, the challenge is to be credible without being boring, engaging without becoming irresponsible and platform-specific without compromising the message. That tension is especially important in areas like gut health, diet, probiotics and the microbiome, where uncertainty creates space for simple but potentially misleading answers. Clinician-led innovation As Medtronic's Chief Medical Officer for Endoscopy, Chiang works at the intersection of clinical practice and medical technology. He explains that innovation in medicine is slow for good reason: new tools must prove safety, clinical value, workflow fit and real-world usefulness before becoming mainstream. But he argues that clinicians need to be more involved in that process because they understand the nuances of patient care, staff experience and adoption better than outsiders can. The conversation also explores colorectal cancer, which is rising among younger adults. Chiang explains why colonoscopy remains the gold standard for prevention, while also noting that lowering screening ages further would create major capacity challenges. He also discusses AI-assisted polyp detection, the future of endoscopy and why fully autonomous colonoscopy remains difficult given the complexity of human anatomy. There's much more in this conversation, including physician career paths beyond traditional practice, how doctors should respond when patients bring AI-generated information to appointments and what people with chronic GI conditions need from clinicians, platforms and online communities. Tune in to hear one of medicine's most visible digital physician leaders explain how doctors can help shape a future where technology, social media and medical innovation better serve patients. * * * Fixing Healthcare is a co-production of Dr. Robert Pearl and Jeremy Corr. Subscribe to the show via Apple, Spotify, Stitcher or wherever you find podcasts. Join the conversation or suggest a guest by following the show on X and LinkedIn. The post FHC #224: Austin Chiang on burnout, misinformation and the future of med-tech appeared first on Fixing Healthcare.

Cybersecurity in healthcare is no longer an IT issue—it's a patient safety issue. In this episode of Med Tech Gurus, we sit down with Skip Sorrels, Field CTO and Chief Information Security Officer at Claroty, to explore how cyber threats are evolving from data breaches into full-scale clinical and operational disruptions. With a unique background as both an ICU nurse and healthcare cybersecurity leader, Skip brings a rare perspective on what actually happens inside a hospital when systems go down. From electronic medical records shutting off to clinicians reverting to paper processes, these events don't just slow operations—they fundamentally impact patient outcomes. We dive into the growing risks tied to connected medical devices and hospital infrastructure, including operational technologies like HVAC systems, water filtration, and building controls—areas increasingly targeted as the "path of least resistance" for attackers. Skip also shares why healthcare organizations must begin treating cybersecurity like disaster preparedness, focusing on operational resilience, recovery planning, and real-world readiness—not just prevention. For MedTech innovators, this episode delivers a critical message: security is no longer a feature—it's a requirement for trust, adoption, and patient safety. If you're interested in healthcare cybersecurity, medical device security, hospital operations, digital health risk, or MedTech commercialization, this episode offers a powerful and timely perspective on one of the most important challenges facing healthcare today.

If your MedTech product isn't selling as quickly as expected, are more salespeople really going to fix the problem?When a MedTech launch underperforms, hiring more salespeople, recruiting another distributor or attending more exhibitions can feel like the obvious answer. But if the market hasn't been prepared and customers don't yet see a compelling reason to change, more sales activity won't solve the underlying problem. In this episode, Hakeem explains why successful MedTech commercialisation and export starts long before launch—and why understanding and preparing your market can save you from trying to force adoption later.In this episode you'll discover:Why MedTech commercialisation should begin months before your product launches, rather than after regulatory approval.Why adding salespeople or export distributors won't fix a market that isn't ready to adopt your product.How understanding what keeps your customers awake at night can help you create demand, prepare the market and accelerate adoption.ActionListen now to learn how to prepare your market before you commercialise or export your MedTech product, so your sales team can convert demand rather than having to create it from scratch.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.

Medical device leadership becomes deeply personal in this conversation with commercial executive Don Donnelly.For more than two decades, Don has helped build commercial organizations, launch disruptive neuromodulation technologies, and develop high-performing sales teams. But the greatest leadership lesson of his career didn't happen in a boardroom—it happened when his nine-year-old son suddenly became seriously ill.Don shares how his family's two-year search for answers ultimately led to a diagnosis of PANDAS (Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal infections), and how that experience transformed the way he thinks about leadership, physicians, patients, and advocacy.Jordan and Don also discuss:• Building startup commercial organizations• What separates good sales leaders from great commercial leaders• Why the best leaders listen first• Lessons learned from launching breakthrough neuromodulation technologies• The future of neurotechnology• Patient advocacy and navigating rare diseases• Why "sometimes behavior is biology"Whether you're in medical devices, healthcare leadership, or simply love stories about resilience, this episode is filled with practical wisdom and genuine humanity.Resources:To purchase "Navigating PANDAS: A Family's Journey to Healing and Advocacy" by Don Donnelly, click here: https://bit.ly/4wFklO7To connect with Don: https://bit.ly/3TFzJeT

Dave Rosa shares how a lifelong drive to help others and his own health challenges led him into 32 years across orthopedics, cardiovascular, and neuro. Dave walks through his path from early marketing roles to becoming a CEO, and explains the innovation behind NeuroOne's electrode platform designed to combine diagnosis and treatment in a single procedure—starting with epilepsy, expanding to trigeminal neuralgia, and now targeting lower back pain. He also discusses early work using the same technology for precise drug delivery to the brain, including a program focused on glioblastoma. Dave closes with leadership lessons on vision, culture, learning from mistakes, and giving back.    Guest links: https://nmtc1.com/ | https://www.linkedin.com/company/n1mtc/ Charity supported: Opportunity International 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 086 - Dave Rosa [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, Dave Rosa. Dave is an entrepreneur with three decades of experience in the medical device industry, spanning a variety of technologies and products. In addition to CEO roles with early-stage medical device companies, Mr. Rosa's background also includes senior roles with C.R. Bard Inc., Boston Scientific Inc., and St. Jude Medical, where his responsibilities included marketing, product development, and business development. He has been named as an inventor on multiple medical device patents, serves on seven corporate boards, and has raised 200 million in the capital markets. Well, Dave, thank you so much for being here today. I am absolutely delighted to have you on the show. [00:01:33] Dave Rosa: Well, thanks for having me. [00:01:34] Lindsey Dinneen: Yeah, of course. I would love, if you wouldn't mind, by starting out and just telling us a little bit about yourself, your background, and what led you to medtech? [00:01:45] Dave Rosa: Yeah. So, born and raised in a small town called Richport, Pennsylvania, outside of Philadelphia. And really was in love with the medtech industry from the time I was much younger. So I, I have been in medtech now, it's going on 32 years and that's everything from large medical device companies to, to startup companies. I've been in so many different areas of medtech. I've been in orthopedics, cardiovascular, and I mean everything involving the heart, I've been in it in some way, shape, or form, a-a-as well as neuro, which is what I'm in now. And, and I think, you know, why did I get into medtech? I think this all goes back to when I was a little kid. You know, I, I was the little kid that was walking street people to my house and bringing them into my home for my mom to make a meal. I don't know that she always appreciated that me doing that, but, but there, there were more than enough times where she sat me down and I was maybe only four or five years old, and she's like, "Honey I, I, I know you wanna help people, but you can't bring everyone home." And I was like, "Oh, oh, you know, okay, Mom." Of course, until the next time. But, you know, I think it started at an early age and, and really has carried through you know, the rest of my career [00:03:07] Lindsey Dinneen: Yeah. Yeah, okay. So you've always been interested in helping people, and you've had a really nice variety of experiences within medtech. But tell us about your path from that early just interest and care in, in people and their wellbeing, to perhaps your educational journey and maybe, like, the first little bit of your career that led you to where you are now. [00:03:32] Dave Rosa: Yeah. So, in high school I was involved in sports and, and even prior to high school, and I had so many physical issues. So I had initially a shoulder problem that was I'll, I'll say pretty complicated, at least back in those times. And what I found is by the time I got to college, and, you know, I'm still trying to figure out what I wanna do with with my life and what career I wanna take. I, I was actually in chemical engineering, but came, came to the conclusion that I hated chemistry, which, which didn't help things out. And, and I really knew, you know, my, my passion was on the medical side, and a lot of it, you know, was driven because of my own issues, my own shoulder issues, because it really put a damper on, you know, any, any potential I had at especially playing baseball. So, so, i- in college, I went to Drexel University, there really wasn't a course for biomedical, undergraduate biomedical engineering that was, like, a graduate program. And, you know, I, I decided that I would take courses in electrical engineering and a program called commerce and engineering, which kinda merges both the business and engineering side of the equation. So, I, I actually started out not in medical. I was in electrical engineering, and I was probably one of the worst electrical engineers working at Westinghouse at the time. And I remember one of the managers saying to me, he's like, "You know, all, all the other engineers and marketing people really like working with you. Why is that?" And I said, "I, I really don't know other than, you know, I've always been a passionate person about whatever I'm doing." So, you know, so at that point, I started thinking that engineering was not the path for me, that you know, that I was really more, much more passionate about medical because it was impacting my life with my shoulder. And then by that time, you know, my knees and everything else started to go as well. But I graduated with a degree in commerce and engineering, and then after working a few years in electrical engineering for Westinghouse Electric I just started knocking on doors because I, I really-- my passion was, you know, helping others, and I wanted to be involved in an area that might help me being orthopedics. So that, that's kinda how I got my first job, knocking on doors, and Stryker Instruments decided they would take a chance on me, and that, that was kind of the beginning. [00:06:12] Lindsey Dinneen: Very nice. And so when you found medical device, was it this really exciting moment of realizing that it could marry your interests in engineering and your desire to help people? Was that like just this cool moment of going, "Oh, wow, like I, I can do both"? [00:06:31] Dave Rosa: Yeah. I, I, you know, I remember actually praying about this, like, "What am I supposed to do?" Like, you know, and, and "How do I go about this?" And I don't know, you know, it, it, it brought back some memories you know, of when my father was you know, was at the end of his life, and he was this stern Italian man. Never, you know, never-- there, there was no discussion about feelings or anything like that. It was like, "You do what I tell you to do. You, you talk when I tell you to talk. Otherwise, you know, you say nothing." So my, my dad's literally on his deathbed, and he says to me, "You know, I, I really wanna thank you, son, for taking care of your mother and I all these years with, you know, medical decisions." And he said, "You know, you, you always were helping people from the time you were a little boy." And it actually stunned me that my dad, who never appeared to be paying attention to anything regarding me, was like, "Hey, you know, you, you know, you really cared about helping people, not just us, but, you know, this, this goes back to the beginning for you." So it, it was also more of a reinforcement of like, "Yeah, I've, I've really gotta be in medtech, and I'm gonna start with, you know, how I can help my own issues and/or, you know, family's members' issues that they may have." [00:07:52] Lindsey Dinneen: Mm-hmm. Yeah. Yeah. I think sometimes we don't realize the impact that we're making at the time and being able to just do what we feel is right and, and what we know helps others can actually make an impact, and then hopefully we get those opportunities like you got with, with your father to s- realize eventually, "Oh, okay, yeah, I, I am, I am on the right path doing, doing the right thing at this time." So yeah, it's great to have those moments of reinforcement, but. [00:08:26] Dave Rosa: And if you fast-forward, you know, to something again, just more reinforcement, although it's much later in my career and I've had other moments like this, but this was just last month. I was at, at a memorial service for one of the physicians that used our product to treat a, a young lady, she was 17 years old at the time for epilepsy. And so the doctor that performed a procedure on her had a tragic accident, passed away, and we were all at this memorial service for him. And the father along with the mother and, and this young lady who's now in college, they came up to me you know, we were, you know, just chatting about how unfortunate the situation is. And when I got ready to, you know, go back to the service he said to me "Sir, I, I just wanna thank you for giving my baby girl her life back." And I mean, those kinds of things, when, when people say those things to you, and like I said, it's happened more than once, and, and it's because of something, you know, that you've you know, committed the, the company to accomplishing, and then you see results like this, there's nothing more rewarding than that. [00:09:39] Lindsey Dinneen: Yeah, of course. Yeah. Thank you for sharing that. So, all right, so in fast-forwarding a little bit you, you started in medtech with Stryker, and then what gave you-- and, and there's probably maybe some things in between-- but what gave you the the idea for what you're doing now? And can you just take us along that journey from starting out in medical device to where you are now, including that just pathway to even, to even higher roles in leadership and that learning curve as well? [00:10:12] Dave Rosa: Yeah, that's-- boy, that's a long story when you've been in it for 30-some years. You know, I, I started out in marketing. I always liked the interaction between customers, meaning, you know, physicians, patients, when, you know, we had the opportunity to, you know, to speak to the patient. And then, you know, I, I I would like to think that maybe some of my decision-making and, and some of my ideas, you know, led to success in some of these companies. And you know, I think upper management you know, wa-was able to identify that I might have some of the, the qualities that they were looking for really in the next generation of leaders. And this goes back to you know, my, my first job in the cardiovascular industry. Gosh, this was in 1995, so, about 30 years ago with Boston Scientific. And I was able to go from a Product Manager to a Director of Marketing. And I was there for a total of about four years, and I, I really enjoyed the strategic part of the job, and I, I wanted to be more involved in that. And I got an opportunity to go to a startup to run sales and marketing also in the cardiovascular space. And that was a, a great experience because, you know, in smaller companies, and this, by the way, was my first opportunity in a smaller company, you know, you, you have to wear a lot of hats. And I liked, I always liked to be more hands-on and still am, to be honest, and, you know, th-this gave me an opportunity to really you know, get involved in more than just what the job detail or the job description called for. And, you know, the-these things all, sometimes, you know, require some luck but definitely, you know, the right timing. And an opportunity in the startup company that I left Boston Scientific for became available at the CEO level, and the the investors-- the company was funded by venture capitalists-- met with me and said, "You know, we, we think you can take the company to the next level." And I think that was back in 2003, and pretty much been a CEO ever since then. But I, you know, I think a lot of the success comes from and confidence from, you know, the, the hiring companies. I, I think what people notice about me is my passion, my, my commitment, and, and probably the fact that you know, I, I think one of the things I'm strong with is developing a, a, a vision. I mean, that's, that's something that I think is really critical with leaders is that you, you've gotta develop a vision for the company, a strategy for the company so that others can understand what the goals are. So that, that's kinda my path. It's, you know, it's, it's I would say every four to five years I've had an opportunity to either start a company or run a company. And then NeuroOne, which is, you know, my current company, I was actually retired when I was approached by a few individuals who had this idea. And what started out as me just, you know, helping them turned into "Gosh, we would love you to run the company." And I really thought there was an opportunity there, you know, to help people who suffered from these neurological disorders, primarily brain-related disorders. But, you know, that, that vision has kind of expanded beyond just the brain into other areas of the body. [00:13:56] Lindsey Dinneen: Wow. Yeah. Okay, yeah. I appreciate you sharing more about your journey. I love the fact that you're both an engineer and you have this creative side with marketing, and you're able to marry all that together. That's, that's really cool, and gives you such a unique perspective on, you know, I would say product development and then commercialization. But okay, so let's talk about your company now, and what are you excited about? What are some of the innovations coming out of it? You mentioned that it sort of s- it started in one place and one focus, and now we get to see it expanding. And so I'd just love to hear all about your company as well. [00:14:33] Dave Rosa: Sure. So, we started out with the intention to develop this electrode technology, and initially it was primarily to be used for brain-related procedures for patients, initially at least, that were suffering with epilepsy. And this, this technology, the, the idea was "Let's combine functions with this" in that it, it, it would have the ability to perform a diagnostic function. And for these patients, the diagnostic function was finding the area in the brain that was triggering these issues. And then once you were able to accomplish that, then using the same device, destroy that brain tissue that was causing the problem in an effort to eliminate the seizures that patients were having. So that, that's kind of where we started. We, we are selling that technology. We have a distribution partner, Zimmer Biomet, that is our exclusive distributor for that technology, and we've had great success in treating patients. You know, the story that I told about the father you know, who thanked me for getting his daughter's life back, that's what that technology is used for. And the-- really what patients had to face before this technology was available is they would have to have a very invasive surgery just for the diagnostic part of the procedure. So the part where you're just trying to identify the problem area, that was one surgery. And we're, we're talking about, you know, drills that are drilling holes, you know, through the skull with these devices being placed in the brain. And then once that part was done, the patients would go home, and they would be scheduled for a follow-up procedure where they would have to come back again, have an invasive procedure in-into the brain, and then that, that second procedure would be the one where they would eliminate or destroy the problematic brain tissue. So if you're a patient, two invasive surgeries, two hospitalizations, two separate devices, and we said, "Why can't you do it with one?" And, and that's, that's where we are. We then more or less leveraged that technology to treat a a condition called trigeminal neuralgia, which is this excruciating facial pain that patients will experience. And it, there-- it's very well known to carry a a high rate of suicide because of how painful this condition is. But we were able to leverage the same system and provide the neurosurgeon you know, with, with a very unique tool to treat that condition. We also-- what I'm also excited about is these-- the, the same platform we're using now to develop technology to treat lower back pain. There's different types of lower back pain. We, we happen to be focusing on two. One that involves issues with the basivertebral nerve, which is a l- a nerve in the lower spine. And then the more common back pain where you have pain that's traveling down the leg, that's sciatic nerve pain. So we've been able to use the same electrode to to develop technologies, unique technologies that would be able to treat that condition. And then finally, drug delivery. These electrodes have a hollow center and we've been able to demonstrate in animals so far that not only can you use it for diagnostics and stimulating through, but you can also deliver therapeutic agents directly into the brain, specifically where you would like to deliver them. And we, we've initiated a program to try to improve really the care for patients that suffer from glioblastomas, which are those brain tumors that carry high rates of mortality. [00:18:45] Lindsey Dinneen: Wow. Wow. Well, there is an incredible amount of innovation coming out of the company, and I'm so excited to follow along and just see all of the difference that you're gonna make in patients' lives. So gosh, first of all, thank you for what you're doing. I, I'm curious, you know, you, you've had such a great career and so many different opportunities to grow into more and more leadership roles. And I, I'm wondering, first of all, what your own leadership philosophy is, sort of as a whole, and then maybe some examples of both good and not as ideal leadership that helped to shape it. [00:19:28] Dave Rosa: Yeah. So, I mean, for me, you know, the, the people that I've always looked at that I think are great leaders are, are those people that can communicate a vision and, and really instill a passion to inspire others in the company to have the same sort of passion to achieve this, this overall vision or this overall strategy. And, you know, I, you know, I-- there, there have been clearly people that I've worked for in my life that I've said, "Gosh you know, they, they really were inspirational to me to be better," not just I would say as a leader, but just more effective overall. And, you know, I, I, you know, I, I-- when I look at my own areas that when I think about leadership and what I can do to, to be more effective, you know, I some of the areas that I've personally looked at i- are things that can make the company more efficient. And artificial intelligence is probably the one that gets, you know, the most attention today. And, and I'm looking to using it, and took a course in this actually to, to really become more efficient and help the company be more efficient in, in developing these technologies and getting them to market as, as quickly as possible. And, and I think, you know, for myself, I'm, I'm very fortunate to be surrounded by a board of directors that I look at that I think have excellent leadership qualities, and it's, it's really, you know, meeting with them on a... and, and just talking to them on a fairly regular basis, picking their mind to see how they would handle things because, you know, I'm, I'm really the, the product of stealing ideas from other people that, that I think you know, have worked well and led to the success of companies and people that they've led. So it's, it's not necessarily taking a course on leadership, but it's surrounding yourself with people that have been successful in leading groups and, you know, getting ideas from them on how to be more efficient, whether it's, you know, taking classes you know, in, in things like AI or, or just, you know, learning from their own success as to how to inspire people to, you know, to really finish the goal for whatever that goal is. [00:21:58] Lindsey Dinneen: Yeah. Yeah, and speaking of inspiring people, how do you as a leader intentionally help shape the company culture that you feel is best for, for people to thrive in? [00:22:13] Dave Rosa: Yeah. So I've, I've always been of the mindset that companies that perform the best utilize ideas that others on the team have. So there, there are, I, I'll give you a great example. I-I find that people that come from big companies have more of a mindset of execution, meaning, "So whatever the boss tells me to do, I do and I'm, I'm not gonna challenge them." So it's, it's one more of, "I, I find out what I need to do and, and and I execute that." You know, in, in our company, one of the things I try to foster is that it's okay to have a, a different opinion. We're all here, you know, trying to be successful, and none of us have all the answers. Now, there's gonna be times when we as a, a team just can't agree, and when those times occur, then, you know, the, the CEO is going to have to make the final decision because that's in my mind, that's, that's really one of the roles of the CEO. But I can tell you, in our company and in other companies I've been in, a lot of the, the great ideas on what to do, you know, have really come from others. They haven't, they haven't come from me. I'm-- I may be setting the overall vision, but sometimes, you know, you, you take a small detour because someone in the group who wasn't afraid to speak up, you know, has an idea or a thought that you know, makes the, the outcome more successful, whether it's shortening the time or coming up with a different idea, a different concept. I constantly try to hi- hire people that have skill sets that I don't have. So for example, I recently, within the last two months hired a guy that had great experience in the pharma space and really how to navigate that space and understands the, the therapies that are out there. And in a very short period of time you know, I realized, "Gosh, this guy, you know, knows so much more than I know and I'm gonna learn a lot from him." So I think it's, it's, it's really empowering the people that you hire, you know, to express what their thoughts and their ideas are because I don't care what CEO you're talking about, none of us, you know, have all the answers. [00:24:33] Lindsey Dinneen: Yes. And recognizing that is, is definitely, I think, key. I think a lot of the leaders that I've been talking to recently talk about exactly what you've mentioned. It's, it's recognizing that y- you know, you, you, you do have your blind spots or your just, your areas of weaknesses, and that's okay 'cause we all do, right? But as long as you're willing to say, you know, "Okay, this might not be my area, but I trust the person whose area I know it is," then, then that's just such a great way to, to handle that and empower the next generation of leaders. So yeah, I love that that's your approach. [00:25:10] Dave Rosa: I also, you know, I, one other area that I think is also critical, and it goes back to what I said about individuals that I've met in larger companies, and I experienced this when I was in a larger company as well. You know, the focus becomes not making a mistake. And and, and it's because you know, the, these employees don't wanna make a mistake that's going to cost them their career in that company. So the safest thing to do is to do what your supervisor tells you to do, as opposed to take a chance and, you know, offer a different idea or a different concept. It's seen as risky and it's because there's this fear of making a mistake. I think it's smaller companies, especially in companies that I've run, you know, my, my philosophy is it's okay to make a mistake, but let's not make the same mistake more than once. I mean, they're, they're there to learn from. So let, let's, let's be smarter the, the second time, you know, because of that experience. But if people are afraid to make mistakes, you'll, you know, you're, you're never gonna get different ideas or different concepts you know, out, out, out amongst the group because of the fear of making a mistake. [00:26:26] Lindsey Dinneen: Mm-hmm. Right. Yeah, absolutely. Providing that, that opportunity and I, I know it's a bit of a cliche, but the, the idea of a safe environment at least to present those ideas and potentially counter opinions, and that's where creativity thrives is when you can iterate and bounce ideas off each other and, and come up with something that's, you know, you couldn't have done by yourself. Yeah, I love that approach. [00:26:50] Dave Rosa: Yeah. [00:26:51] Lindsey Dinneen: Yeah, so okay. This is, this is marvelous. I really appreciate all of this so far. But I'm gonna pivot the conversation a little bit just for fun. So imagine that you were to be offered a million dollars to teach a master class on anything you want. It could be within your industry, but it doesn't have to be. What would you choose to teach? [00:27:13] Dave Rosa: Yeah, this this doesn't fall under maybe necessarily, you know, a a class that you would see in a, a normal curriculum. But, you know, I-- it's, it's something that I've tried to talk to my own children about, and that's teaching them about being thankful for what they have and also, you know, giving back to others that are less fortunate. I-- you know, there's a saying that, that "comparison i- is the thief of joy." You know, the-- I, I think the human race in itself just has a way of always dwelling on, like, what we don't have as opposed to being, you know, thankful to God for all that we do have. And I, and I, I, you know, I, I really think that o- one of the things that I've tried to instill in, in, you know, my, my children, and now they're all grown, is you gotta be grateful for what, what you have, but you gotta find ways to find common ground with people and, and be sure to give back to others that, you know, haven't been as fortunate as you. I, I think that's, you know, what this world should be more focused on than, you know, all, all you hear about today is what we don't agree with and why this side or that political party, you know, is ruining the world. I think if we all focused a lot more of our energy on helping others you know, the, the world would be and this'll sound cliché, a much better place to live in. So if I could teach a course on instilling thankfulness and and the importance of helping others, that's what I would do [00:28:49] Lindsey Dinneen: Yeah. No, that I couldn't agree more. Gratitude and giving back are, are key and, and the world needs more of it, so I love that idea of a masterclass for sure. And how do you wish to be remembered after you leave this world? [00:29:06] Dave Rosa: Yeah, it's-- it kind of goes back to, you know, what my dad said to me, and that was you know, as, as a, a youngster and, and that is, you know, my, my passion and interest to really help others. Yeah, that sums it up the best. [00:29:23] Lindsey Dinneen: Yeah, absolutely. Okay, and final question: What is one thing that makes you smile every time you see or think about it? [00:29:33] Dave Rosa: I, I would say you know, there, there are people that will doubt you and put you down in your career and tell you why, you know, you'll never do this or you'll never do that. And I can honestly say I never thought, you know, I would ever stand in Nasdaq, you know, on Wall Street and take a company public. And, you know, the, the one thing I, I do kind of cherish is I've been able to do this twice, but the first time I remember standing on the stage before the activity started at Nasdaq and one of the people in the company said to me, they said like, "You know, you just had this smile, you know, on your face. You know, it looked like you were thinking of something." And I said, "Yeah, you know, I, I was thinking about all those times that people told me that, you know, I, you know, I would never be successful in my career," and you can define success in different ways, but it, it kind of made me feel good. It was the first time I think I really felt, you know, proud of myself that, "Wow, you know, I'm, I'm one of a very small percentage of people that have been fortunate enough to, to actually you know, take a company public." So, it always makes me smile. [00:30:52] Lindsey Dinneen: Yeah. Yeah, absolutely. Great answer, and that, that's a really cool moment to reflect back on. Well, Dave, this has been a great conversation. I so appreciate your willingness to, to talk with me today, but also to share about the, the incredible work that your company is doing and your heart for helping people from the very beginning of your childhood, and obviously a huge passion of yours throughout your life. And we are so honored to be making a donation on your behalf as a thank you for your time today to Opportunity International, which works to end global poverty by creating and sustaining jobs while also providing small business loans, savings, insurance, and training to more than 14 million people in the developing world. So thank you so much for choosing that organization to support, and thank you for everything that you're doing to change lives for a better world. [00:31:47] Dave Rosa: Well, thanks for having me on the show as well. [00:31:49] Lindsey Dinneen: Of course. [00:31:51] 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.

Move faster without losing focus: why medtech innovation must balance agility, regulation, and patient needs. In this episode, Mike Stuedemann, Co-Founder and Principal Consultant at agilityIRL, discusses how medical device companies can use agile techniques to accelerate product development while maintaining FDA compliance. He explores the regulatory challenges surrounding AI-enabled devices, particularly as technologies continue to learn and evolve after launch. Mike also explains how AI can support quality and regulatory teams by identifying potential risks, flagging requirements for review, and reducing manual work without replacing human expertise. Finally, he shares why personalized medicine, responsible data use, and practical applications of "boring AI" can drive more meaningful innovation while keeping accessibility, affordability, and patient outcomes at the center. Tune in to learn how agile development, human oversight, and patient-centered innovation can help medtech companies navigate a rapidly changing industry! Resources: Connect with and follow Mike Stuedemann on LinkedIn. Follow agilityIRL on LinkedIn and explore their website. Listen to the Take5 IRL podcast here.

Are you pricing your MedTech product based on evidence and value... or simply making an educated guess?Pricing is one of the most important commercial decisions you'll make, yet many MedTech founders spend years developing their product and only a few hours deciding what it's should cost. In this episode, Hakeem shares a practical five-step framework to help you understand your market, quantify your value, validate your pricing, and develop a pricing strategy that supports successful commercialisation and export.In this episode, you'll discover:Why competitor pricing should inform your thinking, but never determine your pricing strategy.How to assess the value your MedTech product creates and use it to justify your price.A practical framework for validating your pricing with clinicians, procurement teams, distributors, and customers before commercialisation and export.Listen now to learn how to price your MedTech product with confidence, strengthen your commercialisation strategy, and avoid costly pricing mistakes before entering new markets.If you need help with your pricing, message me on linkedin with the words "pricing supportThis 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.

How do you turn a lab-born regenerative medical device into a solution that surgeons actually want to use and investors want to back? The path from academic innovation to clinical adoption is full of practical hurdles and strategic pivots, where compelling science alone isn't enough.David Brühlmann welcomes back Eva-Maria Balet, whose journey spans tissue engineering research at EPFL to leading Regenosca through first-in-human trials, fundraising, and an executive MBA completed while running the company. This conversation covers the practical realities behind that journey, from quality control to clinical setbacks to investor pitches.Topics discussed:Defining TissueSpan's regulatory path and quality control as a medical device (02:49)The significance of first-in-human studies and what early clinical experience reveals (04:11)Selecting an initial clinical indication and opportunities for technology expansion (05:50)Realistic assessment of where soft tissue repair technologies apply—and where they do not (07:18)The stepwise progression from in vitro to animal models in product development (08:18)Navigating setbacks, including the impact of Covid-19 on clinical trials, and the value of adaptability (10:36)Bridging science and business in biotech fundraising and communication (12:15)Key takeaways from pursuing an executive MBA alongside building a biotech company (13:42)The importance of collaboration, mindset, and meaningful networks in driving biotech innovation (15:19)Smart insight: The transition from scientist to founder brought its own learning curve. Eva-Maria pursued an executive MBA while running Regenosca, and points to financial and business vocabulary as the skill she'd have built earlier if she could. For a technical founder or CMC lead, the lesson isn't to become a business generalist, it's that the moment you're translating a manufacturing process or clinical dataset into an investor pitch, fluency in the language of accounting, market strategy, and cost structure becomes as load-bearing as the science itself.This week's episode with Eva-Maria Balet steps out of bioprocessing into MedTech, following a collagen scaffold from EPFL lab bench to first-in-human implant. These back-catalog picks cover similar ground: what it takes to win investor buy-in beyond the science, the discipline of turning a lab process into GMP manufacturing, why regulatory classification shapes a product's whole trajectory, and what it really takes to commercialize a lab discovery.Episodes 259 - 260: Why Strong Science Isn't Enough to Get Funded: What Investors Actually Look For with Michael RomeEpisodes 257 - 258: Why Regulatory Affairs Belongs in Drug Design: 30 Years of CMC Lessons from Discovery to GMP Manufacturing with Milan TomicEpisodes 105 - 106: From Proteins to Cell Therapy: Why ATMPs Aren't Just Complex Biologics with Oliver KraemerEpisodes 183 - 184: From Lab to Market: Secrets to Commercializing Cutting-Edge Biotech Innovations with Chervee HoConnect with Eva-Maria Balet:LinkedIn: www.linkedin.com/in/eva-maria-balet-72561737 Regenosca website: www.regenosca.comSupport the show

Why do breakthrough medical technologies still fail to get adopted? In this episode of Med Tech Gurus, we sit down with David Neale, Co-Founder and CEO of Argá  MedTech, to explore what it really takes to bring a differentiated cardiac technology from concept to clinical adoption. Argá is advancing next-generation pulsed field ablation (PFA) for the treatment of atrial fibrillation, with early data showing 100% procedural success, strong safety, and high lesion durability. But as David explains, great clinical data alone isn't enough. Drawing on decades of experience in cardiac rhythm management, David shares why so many promising technologies fail—not because of engineering, but because they ignore physician workflow, hospital operations, and real-world usability. From designing a single, multi-configurable catheter platform to simplifying complex EP lab environments, Argá's strategy is built around one principle: innovation must fit the workflow to win adoption. We dive into lessons from first-in-human trials, the importance of disciplined execution, and why companies must design for three critical stakeholders: clinicians, operational teams, and administrators. David also shares practical insights on site selection, physician alignment, and how to move from strong data to real-world adoption. If you're interested in cardiac electrophysiology, pulsed field ablation, MedTech commercialization, clinical trials, or healthcare innovation, this episode delivers a powerful playbook for turning technology into adoption.

Start earlier than you think: why proactive quality and regulatory planning can save medtech companies time, money, and costly remediation. In this episode, Joseph McGonnigal, Account Manager at Rook Quality Systems, discusses how medtech companies can build stronger quality management systems and better prepare for regulatory submissions. He explains how AI can help teams lay the foundation for high-quality documentation, while emphasizing that experienced professionals remain essential to review outputs, address technical details, and ensure compliance. Joseph also explores the growing regulatory complexity surrounding software-as-a-medical-device, AI-enabled technologies, and de novo submissions. Finally, he shares why startups should document decisions early, establish quality processes from the outset, and avoid waiting until regulatory issues become costly problems. Tune in to learn how early documentation, expert guidance, and proactive quality management can help medtech companies move toward regulatory approval with greater confidence! Resources: Connect with and follow Joseph McGonnigal on LinkedIn. Follow Rook Quality Systems on LinkedIn and explore their website!

Is your MedTech product genuinely ready for commercialisation and export, or are you simply working through a checklist?Many MedTech founders believe that regulatory approval, clinical evidence, patents, and distributor interest mean they're ready for commercial success. But commercial readiness is about far more than ticking boxes. In this episode, Hakeem explains why successful commercialisation depends on multiple factors working together and introduces a structured way of assessing whether your MedTech product is truly ready for commercialisation and export before investing significant time and money.In this episode, you'll discover:Why regulatory approval, clinical evidence, and distributor interest don't automatically mean your MedTech product is commercially ready.The key questions that reveal whether your product is ready for commercialisation, adoption, and export.How to identify commercial risks early so you can make better investment, launch, and export decisions with greater confidence.Listen now to learn how to assess your MedTech product's commercial readiness, strengthen your commercialisation strategy, and export with greater confidence.Message me with CPI on Linkedin, to really see if your product is ready for commercialisationThis 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.

Imagine a wound too large for the body to close on its own. That's the problem Eva-Maria Balet set out to solve, not with living cells, but with a structural bridge that lets the body's own healing mechanisms do the rest.In this episode, David Brühlmann welcomes Eva-Maria Balet, Co-Founder & CEO of Regenosca. Trained at EPFL, Eva-Maria brought her fascination with cellular "factories" from academia straight into entrepreneurship. Rather than chasing elegant science for its own sake, she built her company around a single principle: start with a real clinical need and build backward, collaborating with clinicians from day one so every experiment serves a patient.Highlights & Topics:Why starting with clinical needs—not just scientific excitement—creates meaningful real-world impact in life sciences (02:38)How Eva-Maria's fascination with biotechnology guided her from cell factories to developing scaffolds for tissue repair (03:51)The unmet challenges in current soft tissue repair treatments and where new solutions are needed (05:51)What makes Regenosca's fully-engineered collagen implant, TissueSpan, different from existing meshes and biological materials (07:09)The biological mechanisms behind tissue regeneration using a temporary collagen scaffold (08:28)Translating lab-scale research into a robust, scalable, and regulatory-compliant production process (10:34)The practical realities and hurdles of navigating the medical device vs. biologic regulatory pathways (11:59)Advice on building regulatory expertise into your founding team or leveraging consultants effectively (13:31)The importance of interdisciplinary teams and trust when forming biotech startups (14:36)Smart insight: Eva-Maria put it plainly: what works in the lab has to work reliably every single time you produce it for a patient. That shift, from proving a concept to controlling a process, from raw materials through in-process controls to final product testing, is the same discipline any CMC scientist recognizes: science alone doesn't get a product to patients. Reproducibility does.This week's episode with Eva-Maria Balet steps out of bioprocessing into MedTech, following a collagen scaffold from EPFL lab bench to first-in-human implant. These back-catalog picks cover similar ground: what it takes to win investor buy-in beyond the science, the discipline of turning a lab process into GMP manufacturing, why regulatory classification shapes a product's whole trajectory, and what it really takes to commercialize a lab discovery.Episodes 259 - 260: Why Strong Science Isn't Enough to Get Funded: What Investors Actually Look For with Michael RomeEpisodes 257 - 258: Why Regulatory Affairs Belongs in Drug Design: 30 Years of CMC Lessons from Discovery to GMP Manufacturing with Milan TomicEpisodes 105 - 106: From Proteins to Cell Therapy: Why ATMPs Aren't Just Complex Biologics with Oliver KraemerEpisodes 183 - 184: From Lab to Market: Secrets to Commercializing Cutting-Edge Biotech Innovations with Chervee HoConnect with Eva-Maria Balet:LinkedIn: www.linkedin.com/in/eva-maria-balet-72561737 Regenosca website: www.regenosca.comSupport the show

What makes a country truly AI-ready in 2026? In this episode of UC Today, host Christopher Carey sits down with John Durcan, Chief Technologist at IDA Ireland — Ireland's Foreign Direct Investment Agency — to explore how enterprises are approaching AI adoption, what's driving global tech investment decisions, and why regulation might actually be Europe's secret weapon.John shares insights from his conversations with multinational companies on the ground in Ireland, covering:What separates AI-ready countries from the restHow the EU AI Act is shaping enterprise strategyThe rise of agentic AI across financial services, MedTech, and life sciencesWhy digital sovereignty is now a boardroom conversationThe real impact of AI on jobs — and what companies are doing about itWhether you're a technology leader, investor, or enterprise decision-maker, this is a conversation you won't want to miss.

What does it take to successfully commercialize medical technology in today's rapidly evolving healthcare landscape? In this episode, Mike Monovoukas, CEO and Co-Founder of AcuityMD, shares how a failed startup inspired him to build one of medtech's leading commercialization platforms. From leveraging AI and data to helping companies launch products more effectively, to raising an $80M Series C and building a mission-driven business, Mike offers valuable insights for medtech founders, innovators, and commercial leaders. Tune in to learn why commercialization starts long before product launch and how AI is changing the future of medtech. Mike Monovoukas LinkedInAcuityMD LinkedInAcuityMD WebsiteAcuityMD Press Release Biodesign Book Link Duane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.

In this episode of Medsider Radio, we sat down with David Veino, President and CEO of Neuros Medical.Neuros is commercializing the FDA-approved Altius Direct Electrical Nerve Stimulation System for chronic post-amputation pain.Before Neuros, David held senior commercial leadership roles at Cardiovascular Systems (CSI) and Stryker, and helped grow CSI's coronary and peripheral business from approximately $50 million to more than $250 million in annual revenue while leading key amputation-prevention initiatives. He also serves as a private equity advisor with Sectoral Asset Management. In this interview, David discusses how commercialization begins by mapping the patient journey upstream, what it takes to generate gold-standard clinical evidence for a novel therapy, how investors assess scalable medtech businesses, and how to build an investor pitch that earns the next meeting.  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 David Veino, 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(03:02) - David's 30-year medtech journey from cardiovascular devices to leading Neuros (04:38) - How Neuros is treating chronic post-amputation pain with on-demand neuromodulation (11:08) - Why Neuros completely changed its strategy halfway through the pivotal trial (15:36) - Why commercialization starts with referral pathways, not end-users (18:09) - How prosthetists became one of Neuros' most important referral sources (26:11) - What it takes to generate gold-standard clinical evidence for a first-of-its-kind therapy (37:41) - Building an investor pitch that earns the next meeting (41:42) - What gets David excited enough to invest in a medtech company

Joanna Nathan, CEO and co-founder of Prana Surgical, adjunct professor at Rice University and a former MedTech investor who spent years at the J&J MedTech Center for Device Innovation before crossing over into building herself. Her company recently secured FDA clearance for the Prana System, a tissue-sparing platform rethinking how early stage lung cancer is diagnosed and treated.In this episode, Joanna shares the deeply personal story behind her move from investing back into operating, having lost her four year old son in 2021 and wanting proximity to patient impact rather than evaluating innovation from the sidelines. It is an honest and moving conversation about what actually drives someone to take on a decade-long mission.We get into what she learned watching hundreds of pitches from the investor seat, why a no is very often about portfolio construction and timing rather than the quality of your idea, and why a fundraising pitch is a vision document backed by evidence rather than a journal article. Joanna then breaks down the problem Prana is solving, why removing large portions of lung for a tiny early stage nodule is no longer justifiable and how the system is right-sized for the level of risk these smaller lesions present.We also explore the changing face of lung cancer, the rise of never smokers now approaching one in three patients, why the disease is getting younger and more female, the role of mobile screening in rural areas and where AI genuinely helps rather than replaces clinical judgement. Joanna closes with hard-won advice for anyone thinking about founding a company and why community is what carries you through.Timestamps[00:01:38] From Research to Investing to Building: The Path Back to Operating[00:03:33] Why a No From an Investor Is Rarely About Your Idea[00:05:29] Why a Pitch Is a Vision Document Not a Journal Article[00:07:16] The Problem With Early Stage Lung Cancer Surgery Today[00:09:22] The Rise of Never Smokers and a Disease That Is Changing Fast[00:11:03] Why Women Under 50 Now Face Higher Lung Cancer Rates[00:13:18] Getting Creative on Access: Mobile CT Screening in Rural Areas[00:17:21] AI in MedTech: Assisting Clinical Judgement Not Replacing It[00:19:22] How Houston Became an Unlikely MedTech Powerhouse[00:24:06] Who Should Not Become a Founder and the Decade-Long QuestionConnect with Joanna - ⁠linkedin.com/in/joannacnathan/Learn more about Prana Surgical - https://www.pranasurgical.com/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/

From generic implants to patient-specific solutions: how additive manufacturing is expanding what is possible across medtech. In this episode, Anekant Jain, Manager, Polymer Technologies at EOS, discusses how industrial additive manufacturing is transforming healthcare by enabling the production of customized implants, prosthetics, dental devices, and other patient-specific technologies. He explains why additive manufacturing extends far beyond traditional 3D printing, requiring scalable production, qualified materials, reliability, and repeatable outcomes. Anekant also explores how advances in sensors, materials, and manufacturing are creating more responsive prosthetics with haptic feedback and stronger integration with the human body. Finally, he examines the barriers to broader adoption, including qualification processes, reimbursement, cost, and access, and explains why the industry must rethink what is possible rather than simply reproducing traditional solutions. Tune in to learn how additive manufacturing, customization, and cross-industry collaboration are pushing the boundaries of medical innovation! Resources: Connect with and follow Anekant Jain on LinkedIn.  Follow EOS on LinkedIn and explore their website at eos.info.

What do clinicians actually want before they'll adopt your MedTech product?Many MedTech founders focus on product features, clinical evidence, and regulatory approval, believing these alone will drive adoption. But clinicians evaluate new technologies through a very different lens. In this episode, Hakeem shares the five biggest lessons from his conversation with Dr Tangwan Azorfor, giving you a clinician's perspective on what really influences adoption and how you can better align your commercialisation strategy with the realities of clinical practice.In this episode, you'll discover:Why improving patient care is the first thing clinicians look for when evaluating a new MedTech product.How workflow, training, and real-world clinical experience influence adoption more than many founders realise.Five practical lessons to help you position your MedTech product for stronger clinical adoption from a clinician's perspective.Listen now to understand what clinicians really want before adopting a new MedTech product and learn how to apply these insights to improve adoption and commercial success.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 Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we're reviewing the list of top health technology hazards identified by ECRI. ECRI is an independent, nonprofit organization that improves the safety, quality, and cost-effectiveness of care across all healthcare settings. Each year, they publish this Top 10 list to help bring awareness to problem technology concerns and encourage improvement. During this conversation, the following questions are addressed:We discussed this in a podcast in March 2024. Why are we discussing this again?What is ECRI, and what is the purpose of this list?Why is this topic important to device manufactures and to patients?What's on the current 2026 hazards list?How do the hazards in the 2026 list compare to previous years?At the end of the day, what, if anything, have we learned? Are we going in the right direction or simply treading water?What are today's takeaways?Listen to this discussion and see if you have issues you should address based on this list. If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com, and we'll see if your ideas/inquiries/suggestions align with a future episode.Send us Fan Mail For more medtech news and information, visit https://www.mpomag.com. 

What does it really mean to put the patient at the center of healthcare innovation? In this episode of Med Tech Gurus, we sit down with Stephanie Hunter-Banks of Jazz Pharmaceuticals, a leader in medical learning, patient engagement, and rare disease advocacy. But what makes this conversation truly powerful is that Stephanie doesn't just study the patient journey—she lives it. As a rare disease patient herself, Stephanie brings a deeply personal and professional perspective to how healthcare systems, MedTech companies, and clinicians engage with patients. Her journey—spanning more than two decades without a definitive diagnosis—offers a raw and honest look into what many patients experience but few organizations truly understand. Stephanie shares why scientific innovation alone isn't enough—and how empathy, trust, and meaningful engagement are critical to driving better outcomes. From the challenges of the "diagnostic odyssey" to the importance of resilience, she provides a framework for how healthcare leaders can rethink patient-centricity—not as a buzzword, but as a real partnership. We also explore the role of medical affairs in translating complex science into real-world clinical decisions, the gaps that still exist between providers and patients, and how leaders can build teams grounded in trust, connection, and growth. If you're interested in rare disease, patient engagement, medical affairs, healthcare leadership, or MedTech innovation, this episode delivers a powerful reminder: the future of healthcare isn't just about better technology—it's about better understanding the people it serves.

What separates companies that consistently grow from those that simply launch products? In this episode, Caitlin Mayer, Senior Director of U.S. Marketing for Medtronic's Acute Care & Monitoring business, shares the go-to-market principles that have helped her team build stronger customer partnerships, align cross-functional teams, and accelerate growth through portfolio-based marketing. Drawing on real-world experience leading commercialization strategies in one of healthcare's fastest-growing care settings, Caitlin explains why today's customers expect more than products. They expect solutions that improve workflows, deliver economic value, and solve meaningful operational challenges. She also shares the planning process her team uses to unite marketing, sales, clinical, and product teams around a single business objective, creating the alignment needed to execute consistently and drive measurable results. What you'll learn: 1. Why portfolio selling creates stronger customer partnerships than product-centric selling. 2. How customer insights should shape positioning, segmentation, and go-to-market strategy. 3. How cross-functional alignment creates better execution and measurable business results. 4. A practical framework for moving from product launches to sustainable revenue growth. About Caitlin Mayer: Caitlin Mayer is the Senior Director of U.S. Marketing for Medtronic's Acute Care & Monitoring business. With more than 15 years of experience in healthcare marketing, she specializes in customer-centered go-to-market strategy, cross-functional alignment, and building commercial programs that drive measurable growth. Resources: • Connect with Caitlin Mayer on LinkedIn • Follow Medtronic on LinkedIn • Explore the Medtronic website

If your MedTech product already has strong clinical evidence, why are clinicians still hesitant to adopt it?Many MedTech founders assume that if adoption is slow, the answer is to generate more clinical evidence. But from a clinician's perspective, the real barrier is often confidence rather than proof. In this episode, Hakeem unpacks a real commercial decision with consultant cardiologist Dr Tang Wan, revealing why trusted local reference sites can have a greater influence on adoption than another published study, and how founders should use this insight to strengthen their commercialisation strategy.In this episode, you'll discover:Why clinicians don't always need more clinical evidence before adopting a new MedTech product.How trusted local reference sites reduce the perceived risk of adopting an innovative medical device.Why your first customers can become your most influential commercial asset by accelerating future adoption.Listen now to discover why trusted reference sites often matter more than additional clinical evidence and learn how to use your early customers to drive wider MedTech 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.

Most agency owners say they serve everyone. The ones building real, sustainable profit say the opposite. In this episode, Rachel Knutton, CEO and Founder of Alluvia Studio, shares how she built a thriving niche agency in one of the most regulated and complex industries in the world: MedTech. You'll hear how her background inside hospital C-suites, operating rooms, and medical device sales became the foundation of everything her agency does today. Rachel also covers her conference strategy for LSI Life Science Intelligence events, how she built a referral network with investors and strategic partners, and why core values like Joy and Continuous Improvement are two of her most powerful business tools.Key takeaways:Deep industry experience. Rachel Knutton built Alluvia Studio on firsthand knowledge of hospital systems.Niching in a highly regulated industry. MedTech marketing requires understanding regulatory issues, reimbursement systems, and payer complexity.Conference strategy is a long game worth playing. Sit in sessions and generate media assets through sponsorships.Your best referral sources may not be your current clients. Most valuable relationships at industry events.Pitch deck expertise in the MedTech space. Ability to simplify complex data clearly.If your agency is still trying to be everything to everyone, this episode is your wake-up call. Tune in to the full episode of Med Tech Marketing with Rachel Knutton.Find more podcast episodes on our website: anderscpa.com/learn/podcasts/  Episode resources:●       Anders Virtual CFO website: anderscpa.com  ●       Love our content? Sign up for our newsletter:  https://anderscpa.com/learn/    ●       Check out the Virtual CFO Playbook Course:  https://anderscpa.com/virtual-cfo-services/vcfo-playbook/     Quotes-Rachel Knutton: "Once you identify your core values, you're going to attract the right clients, partners, and team members." -Jamie Nau: "You're only as good as the work you've done, the people you've met, and the books you've read."Rachel Knutton is a medtech marketing strategist and founder of Alluvia Studio. She has 30+ years in healthcare and leads a 17-person team serving startups and global medtech brands. Rachel is the CEO and Founder of Alluvia Studio, a MedTech marketing agency based in Cookeville, Tennessee. With a background spanning hospital C-suite leadership, medical device launches, and direct device sales, Rachel brings rare, firsthand industry knowledge to every client engagement. Alluvia Studio specializes in branding, content development, and presentation design for medical device startups, investors, and large strategics in the life science space.LinkedIn: http://linkedin.com/rachelknuttonCompany: Alluvia StudioWebsite: http://www.alluviastudio.com FB: https://www.facebook.com/alluviastudio/ LI: https://www.linkedin.com/company/alluviastudio/ IG: https://www.instagram.com/alluviastudio/?hl=en  The Creative Agency Success Show helps service-based business owners master the financial side of growth. Hosted by Jamie Nau, Director of Virtual CFO Services/ Virtual CFO, and Jody Grunden, Partner and Virtual CFO Practice Leader at Anders, the podcast dives into essential financial strategies for scaling creative agencies.  Website: https://www.buzzsprout.com/2458889    FB: https://www.facebook.com/vcfobyanders    LI: https://www.linkedin.com/company/vcfobyanders/   IG: https://www.instagram.com/vcfobyanders    YT: https://www.youtube.com/@vcfobyanders     Jamie Nau, CPA, Director of Virtual CFO Services/ Virtual CFO, is a seasoned financial expert with a deep understanding of business growth stages.  Jamie has worked extensively with middle-market and large companies, providing key financial insights.  Website: https://anderscpa.com/    FB: https://www.facebook.com/vcfobyanders   LI: https://www.linkedin.com/in/jamienau/   https://www.linkedin.com/company/vcfobyanders/  IG: https://www.instagram.com/vcfobyanders/ YT: https://www.youtube.com/@vcfobyanders 

In this episode of Medsider Radio, we sat down with Vijit Sabnis, co-founder and CEO of Adaptyx Biosciences.Adaptyx is a Stanford spinout developing wearable technology for continuous molecular monitoring.Over the past 20 years, Vijit has worked at the intersection of deep technology as an inventor, founder, and investor. Before Adaptyx, he was a Partner at Khosla Ventures and co-founded Solar Junction to commercialize high-efficiency solar cell technology. He holds a Ph.D. in Electrical Engineering from Stanford.In this interview, Vijit discusses how to recognize when a scientific idea is worth building a company around, how to build startup-style learning cycles when spinning technology out of academia, and designing products that are easy for clinicians and consumers to adopt. 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 Vijit Sabnis, 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(03:17) - Vijit's path from Stanford, solar energy, and venture capital to building Adaptyx (07:25) - How Adaptyx is trying to do for hormones what continuous glucose monitors did for diabetes (13:50) - The signals Vijit looked for before founding Adaptyx (25:35) - How Adaptyx turned academic research into startup-speed learning cycles (32:15) - Why cortisol became the company's first clinical application (36:26) - How Adaptyx is designing new molecular data to fit existing clinical workflows (42:12) - Why new consumer health platforms opened new paths to commercialization (47:24) - Fundraising in an era of shorter attention spans

Breaking into medical device sales—or landing your next opportunity—has never been more competitive.In this episode of the Chase MedSearch Podcast, Jordan Chase sits down with recruiter Jay Waggoner to share three decades of hiring experience and discuss what separates candidates who consistently receive offers from those who never make it past the interview.Whether you're trying to break into medical device sales, advance your career, or simply understand how top MedTech companies evaluate talent, this conversation is packed with practical, real-world advice from professionals who interview thousands of candidates.In this episode, you'll learn:How to stand out in today's competitive medical device job marketThe biggest mistakes candidates make during interviewsWhat hiring managers actually look for beyond the résuméHow networking can accelerate your careerThe habits and characteristics shared by top-performing sales professionalsAdvice for recent graduates, experienced reps, and career changersWith more than 30 years of executive recruiting experience and thousands of successful placements, Jordan shares lessons learned from helping many of the industry's leading medical device companies build high-performing commercial teams.Whether your goal is your first medical device sales role or your next leadership opportunity, this episode will help you approach your job search with greater confidence and a clearer strategy.Connect with Chase MedSearch

As AI and software become embedded in more medical technologies, companies must balance the pressure to innovate quickly with the responsibility to protect patients. In this episode, Suzanne Levy Friedman, Partner at Honigman, discusses how medical device and digital health companies can navigate evolving FDA regulations and bring products to market more efficiently. She explains how regulatory counsel helps organizations determine whether products fall under FDA oversight, distinguish wellness technologies from regulated devices, and build effective commercialization strategies. Suzanne also explores the growing tension between rapid innovation, particularly in AI, and the FDA's responsibility to protect public health. Finally, she shares how clearer regulatory guidance and early legal involvement can help manufacturers avoid costly setbacks and better operationalize compliance. Tune in to learn how early regulatory planning can help medtech companies innovate responsibly, reduce risk, and bring valuable technologies to patients more efficiently! Resources: Connect with and follow Suzanne Levy Friedman on LinkedIn. Follow Honigman on LinkedIn and explore their website. Contact Suzanne at sfriedman@honigman.com.

Have you ever stopped to ask yourself how clinicians really decide whether to adopt a new MedTech product?Understanding how clinicians make decisions is one of the most overlooked aspects of MedTech commercialisation. Product features and clinical evidence matter, but they're only part of the decision. In this episode, Hakeem explores what really influences clinician adoption, from patient outcomes and workflow to trust, ease of use, and perceived value, helping MedTech founders better prepare their products for commercial success.In this episode, you'll discover:How clinicians really evaluate whether to adopt a new MedTech product.The key factors that influence clinical adoption beyond evidence alone.Practical insights to strengthen your commercialisation strategy and improve MedTech adoption.Listen now to discover how clinicians make adoption decisions and learn how to position your MedTech product for stronger commercial success and wider clinical 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.

Many medical device startups assume they're audit ready because they have documented procedures, completed templates, and a Quality Management System in place.However, successful audits require much more than organized documentation.In this episode of the Medical Device Made Easy Podcast, we welcome Chiratana Pot from Enlil to discuss what true audit readiness looks like and why continuous compliance is far more effective than preparing only when an audit is scheduled.What You'll LearnWhat Is an Audit Really?Many organizations view audits as exercises designed to uncover mistakes.In reality, audits evaluate whether your Quality Management System is implemented effectively and consistently—not simply whether procedures exist.Compliance vs. Audit ReadinessBeing compliant and being audit ready are not always the same.The discussion explores how companies can move beyond documentation and demonstrate that their processes are actively followed throughout the organization.Common Startup MistakesDrawing from experience working with MedTech startups, Chiratana shares the most frequent challenges organizations encounter before their first audit, including assumptions that often lead to unexpected findings.Why Traceability MattersOne of the central themes of the episode is traceability.We examine how effective traceability connects requirements, risks, design decisions, verification activities, and documentation—making change management more efficient and strengthening overall compliance.How Enlil Supports Connected DevelopmentThe conversation concludes with an overview of Enlil's approach to connected development, explaining why integrating quality into product development from the beginning helps organizations maintain continuous audit readiness rather than relying on last-minute preparation.Key TakeawayAudit readiness is not a checklist completed before an inspection.It's the result of building a culture where quality, traceability, and compliance are embedded into everyday work.For MedTech startups, developing this mindset early can simplify audits, improve product quality, and create a stronger foundation for long-term regulatory success.Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.Who is Chiratana (CP) Pot? Chiratana (CP) Pot is Senior Director of Product at Enlil, a cloud-native, AI-driven development traceability platform built for medical device and life sciences organizations. Enlil connects quality, regulatory, R&D, manufacturing, and operations teams through a unified system of record, enabling traceability, auditability, and regulatory readiness across the product lifecycle. CP works with MedTech organizations to strengthen design controls and audit readiness. He is a frequent contributor on topics including design controls, lifecycle traceability, and regulatory readiness, helping organizations move beyond documentation compliance to evidence-based product development.LinkChiratana's linkedin: https://www.linkedin.com/in/chiratana-pot/Website: https://enlil.com/Enlil's LinkedIn: https://www.linkedin.com/company/enlil-inc/Social Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldeviceThis podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

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:

In fast-moving technology markets, innovation only creates value when companies can connect it to real business outcomes and bring people along through change. In this episode, Danny Chu, VP of High Tech at Globant, shares what he is seeing at the intersection of AI, robotics, and medtech from the floor of DeviceTalks in Boston. He discusses how minimally invasive technologies are reshaping care delivery and why AI represents a major inflection point for both service providers and customers. Danny explains that successful adoption requires more than advanced technology, emphasizing change management, human safety, and measurable business outcomes such as revenue growth, cost reduction, and operational efficiency. He also highlights the importance of modeling edge cases before scaling automation and maintaining a people-first approach throughout technology transformation. Tune in to learn how leaders can approach AI and robotics with a stronger focus on people, outcomes, and long-term adoption. Resources: Connect with and follow Danny Chu on LinkedIn or reach out via email. Follow Globant on LinkedIn and explore their website.

Quality is often treated like a necessary function rather than an exciting career path. But working in quality can give professionals in pharma, biotech, and MedTech a much broader understanding of how regulated businesses actually operate.In this video, Subhi Saadeh explains three reasons everyone in the industry should consider spending time in quality:You learn how the business works. Quality follows the product across its lifecycle from development and suppliers through manufacturing, operations, regulatory changes, and post-market activities.You develop judgment. Quality professionals regularly make structured, risk-based decisions in gray areas and document those decisions so they can withstand audits, inspections, and future review.You learn to influence without owning everything. Quality is often accountable for outcomes without directly controlling every activity, which requires strong questions, clear communication, and the ability to help teams navigate competing priorities.Even if you do not spend your entire career in quality, the experience can make you a stronger decision-maker, collaborator, and leader throughout the rest of your career.00:00 Why Quality Matters00:35 Why Work in Quality01:41 Reason One: Learn How the Business Works02:47 Reason Two: Make Defensible Decisions05:23 Reason Three: Influence Without Authority07:43 Key TakeawaysAbout SubhiSubhi Saadeh is a consultant, trainer, auditor, and the founder and principal of Let's Combinate. He has spent his career across medical devices and pharmaceuticals, with experience spanning research and development, industrialization, quality systems, and combination products. Through Let's Combinate, he helps professionals and organizations better understand the intersection of drugs, devices, quality, and regulatory requirements.

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.

At this year's Medtech MVP, a panel of industry experts explored how robotics are changing healthcare beyond the operating room. Robotic technologies are being deployed across inpatient care, rehabilitation, logistics, and remote patient support. Moderated by Virginia L. Giddings of Edwards Lifesciences, the panel includes Amanda Baumann of Stryker; Nir Goldenberg of Mayo Clinic Ventures; Kate Jackson Hobbs of Intuitive; and Maggie Nixon of Capstan Medical. Together they discuss the workforce, financial, and reimbursement considerations shaping adoption and how AI advancement will affect the future of robotics. Medtech Talk Links:  Cambridge Healthtech Institute   Medtech Talk  Medtech MVP Edwards Lifesciences: Edwards Lifesciences Stryker: Stryker Mayo Clinic: Mayo Clinic Intuitive: Intuitive  Capstan Medical: Captstan Medical  

In this episode of Medsider Radio, we sat down with Bob Paulson, President and CEO of Sonex Health. Sonex's UltraGuideCTR device is a minimally invasive technology that enables ultrasound-guided carpal tunnel release procedures to be performed outside the surgical suite using local anesthesia, expanding patient access and reducing the cost of care.Before joining Sonex, Bob led multiple venture-backed medical device companies through commercialization, including NxThera, acquired by Boston Scientific, Restore Medical, acquired by Medtronic, and VentureMed Group. Earlier in his career, he held senior leadership roles at Medtronic, Advanced Bionics, and Endocardial Solutions, which was acquired by St. Jude Medical.In this interview, Bob explains how to build a reimbursement strategy before your first clinical study, drive physician adoption when introducing a new care pathway, and raise capital aligned with value inflection points. 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 Bob Paulson, 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(03:19) - Bob's path from Medtronic to multiple medtech exits before joining Sonex (05:38) - Why 80% of eligible carpal tunnel patients avoid surgery — and how Sonex is changing that (11:11) - The reimbursement challenge that reshaped Sonex's clinical evidence strategy (19:07) - Reimbursement is a three-leg process: FDA, CPT, and payer coverage (22:07) - Reverse engineering your company from the exit you're trying to achieve (29:35) - How Sonex helped surgeons move carpal tunnel procedures out of the OR (39:06) - Sonex's "pitcher-catcher" approach to physician and patient adoption (41:59) - Bob's framework for choosing investors who can finance the entire journey, not just the next round

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.

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.

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!