The MedTech Podcast

Karandeep Singh Badwal

The MedTech Podcast shares the journey behind the path of the people shaping the MedTech industry and its future. Join me as I connect with industry leaders, thought providers and innovators.

Hosted by Karandeep Singh Badwal, Karandeep is a Quality & Regulatory Consultant specialising in the MedTech Industry. If you have any ideas for future episodes or would like to be on the podcast then feel free to connect with me via the links below

Follow Karandeep on LinkedIn: https://www.linkedin.com/in/karandeepbadwal/

Follow Karandeep on YouTube: https://www.youtube.com/c/KarandeepBadwal/

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20 episodes
Updated August 3

Episodes20

Newest first

August 3 · 24 min
#104 From Investor to Inventor with Joanna Nathan: Rethinking Early Stage Lung Cancer Surgery, Raising Capital and the Changing Face of the Disease
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 Question Connect 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/@KarandeepBadwal⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ Medical device training courses delivered by Karandeep through Bywater - ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.bywater.co.uk/
July 20 · 26 min
#103 Why Faster Is Not Always Better with Basant Bajpai: EU MDR vs FDA, the GCC Regulatory Landscape and Where Innovators Get Stuck
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 Clinicians Connect with Basant - https://www.linkedin.com/in/basant-bajpai-phd-63565961 Learn 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/@KarandeepBadwal⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ Medical device training courses delivered by Karandeep through Bywater - ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.bywater.co.uk/
June 1 · 25 min
#102 The End of the Amyloid Era with Isaac Stoner: Treating Alzheimer's as a Disease of the Immune System
Isaac Stoner, CEO of MindImmune Therapeutics, a drug discovery company pioneering a new class of medicines for Alzheimer's disease and other neurodegenerative conditions. Isaac has built his career moving between the founder seat and the investor seat. He was the founding CEO of Octagon Therapeutics, the first team member at liquid biopsy company Firefly BioWorks and has evaluated life science companies for investment at Slater Technology Fund, PureTech Health, KdT and Action Potential Venture Capital. At MindImmune Therapeutics, he is chasing one of the boldest ideas in neuroscience: that Alzheimer's may in fact be an autoimmune disease that presents in the brain. In this episode Isaac explains why the amyloid hypothesis that has dominated Alzheimer's research for 30 years has run its course, and why MindImmune is taking an immunology-first approach built on brain tissue donated by Alzheimer's patients. He breaks down the three biggest risk factors for the disease, how he pitched a 30 million dollar Series A on a condition where 99.9% of drugs have failed and what it would mean to develop a therapy bigger than the GLP-1 weight loss drugs. We also get into the founder-to-investor-to-founder journey, why a brilliant scientific founder is often the wrong person to sit in the CEO seat and the hard truths every aspiring biotech founder needs to hear before striking out on their own. Timestamps [00:02:50] Why a Career Investor Keeps Getting Pulled Back Into Building [00:05:25] Shutting Down Octagon Therapeutics and the Chip It Left Behind [00:07:10] Why MindImmune Treats Alzheimer's as an Autoimmune Disease [00:08:20] Why 30 Years of the Amyloid Hypothesis Has Run Its Course [00:10:05] The Three Biggest Risk Factors for Alzheimer's and What You Can Do [00:12:15] How He Raised a $30 Million Series A on the Hardest Disease in Medicine [00:15:30] Why 99.9% of Alzheimer's Drugs Fail and What Makes This Different [00:18:35] Why a Brilliant Scientific Founder Is Often the Wrong CEO [00:22:20] Where MindImmune Goes Next: AMD, ALS and Beyond [00:28:00] Final Advice: Get Into Biotech for the Right Reasons Connect with Isaac - ⁠https://www.linkedin.com/in/isaacstoner/⁠ Learn more about MindImmune Therapeutics - ⁠https://www.mindimmune.com/⁠ Get in touch with Karandeep Badwal - ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.linkedin.com/in/karandeepbadwal/ ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ Follow Karandeep on YouTube - ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.youtube.com/@KarandeepBadwal⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ Medical device training courses delivered by Karandeep through Bywater - ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.bywater.co.uk/
May 4 · 24 min
#101 When Great Technology Is Not Enough with Shai Policker: Why most MedTech Startups Still Fail, Venture Studios vs VC and the Israeli Edge
Shai Policker, Co-Founder and Managing Partner at Edge Medical Ventures, a medtech venture studio and fund focused on developing and investing in medical devices that address unmet clinical needs. With a BSc in Electrical Engineering from the Technion, an MBA from Columbia Business School and over 25 years building medical device companies, Shai has founded or scaled 18 companies across cardiovascular care, surgery and respiratory health, filing more than 40 patents along the way. In this episode, Shai cuts straight to something most investors won't say out loud: that even a great technology with strong clinical data can still fail. Not because the product is wrong but because the process takes too long and the funding runs out. He breaks down the fragmented decision-making landscape in healthcare, why physicians loving your product means almost nothing if the payer isn't on board and why reimbursement is the real gatekeeper that kills more companies than bad science ever will. We also explore what makes Edge Medical Ventures different from a traditional VC fund. Shai explains how their venture studio model starts from validated unmet needs with a strategic partner already at the table and how their hands-on go-to-market support continues well past the R&D phase. A combination that helped one portfolio company go from zero to FDA approval with distribution agreements and paying customers on just $2.5 million. We also get into the Israeli startup mindset, the right way to think about IP and patents and how to know when a founder should step aside. Timestamps [00:00:17] What Pulled an Electrical Engineer Into MedTech 25 Years Ago [00:01:48] What 18 Companies Taught Shai That One Never Could [00:03:04] How to Know If the Problem Is Painful Enough to Build Around [00:04:56] Why 80% of MedTech Startups Fail Even With Great Technology [00:07:53] What a Venture Studio Actually Is and How It Differs From a VC Fund [00:10:51] The $2.5 Million Company That Got FDA Approval and Started Selling [00:13:54] Why Israeli Startups Move Faster Than Everyone Else [00:17:28] How to Think About Patents Without Becoming Obsessed With Them [00:23:44] Balancing Speed and Discipline Without Creating Expensive Mistakes [00:26:20] Final Advice: What Shai Wishes Every MedTech Founder Knew Connect with Shai - https://www.linkedin.com/in/shai-policker-b8760a3/ Learn more about Edge Medical Ventures - https://edgemed.vc/ Get in touch with Karandeep Badwal - ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.linkedin.com/in/karandeepbadwal/ ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ Follow Karandeep on YouTube - ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.youtube.com/@KarandeepBadwal⁠⁠⁠⁠⁠⁠⁠⁠ Medical device training courses delivered by Karandeep through Bywater - ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.bywater.co.uk/
April 20 · 33 min
#100 Early Stage vs Commercial MedTech with Cristiano Fontana: The 97% of MedTech Nobody Talks About, Getting Innovation to Market and What MedTech Conferences Are Getting Wrong
Cristiano Fontana, founder and CEO of Three Bridges, a Milan-based advisory firm helping early-stage MedTech companies navigate the full journey from innovation to market. With over 25 years in the industry starting in the family warehouse handling surgical drains and prostheses as a teenager, Cristiano has a perspective on this business that very few people can match. In this episode, we kick things off with something a little different: a conversation about dressing well, the discipline behind it and why confidence is as much about how you present yourself as what you know. From there, we get into something both of us have strong opinions on. Cristiano breaks down why the conference ROI is so hard to measure, why ghosting has become an epidemic in the industry and why the real payoff from an event can take three years to materialise. He also delivers one of the most honest assessments you'll hear: that early-stage MedTech is just 3% of the industry and that the 97%, the commercial machine that actually drives revenue, is largely invisible to the innovation bubble. We also explore what a better event model could look like, why trust beats value proposition every single time in a crowded advisory market and what innovators consistently get wrong when they think one conference pitch will change everything. Timestamps [00:00:33] Why Dressing Well Is a Form of Discipline, Not Vanity [00:05:00] From the Family Warehouse to 25 Years in MedTech [00:07:48] The 97% vs 3% Split That Nobody in Early Stage Wants to Hear [00:08:37] What MedTech Conferences Are Getting Wrong [00:09:35] The Ghosting Epidemic and What It Reveals About Human Nature [00:10:14] Why Conference ROI Can Take Three Years to Show Up [00:12:30] You Don't Sell on Value Proposition, You Sell on Trust [00:13:17] The Uncomfortable Truth About So-Called Investors at Events [00:20:42] What a Better, More Targeted Event Model Would Look Like [00:30:41] Final Advice: Fill Your Gaps Fast and Stop Seeing Experts as a Cost Connect with Cristiano - ⁠⁠⁠https://www.linkedin.com/in/cristiano-fontana-medtech-businessdevelopment/ Learn more about ThreeBridges - ⁠⁠⁠⁠https://www.threebridges.it/ Get in touch with Karandeep Badwal - ⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.linkedin.com/in/karandeepbadwal/ ⁠⁠⁠⁠⁠⁠⁠⁠⁠ Follow Karandeep on YouTube - ⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.youtube.com/@KarandeepBadwal⁠⁠⁠⁠⁠⁠⁠ Medical device training courses delivered by Karandeep through Bywater - ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.bywater.co.uk/
April 6 · 21 min
#99 Stop Calling It AI: Machine Learning, LLMs and the Truth About Healthcare Automation with Manish Patel
Dr. Manish Patel, co-founder and CEO of Jiva.ai and Chair of the AI Subcommittee at the BIA, where he advises the UK Government on AI policy, data privacy and healthcare applications. With a PhD in Modelling of Complex Systems from UCL and nearly a decade building algorithmic trading systems in investment banking, Manish brings a rare depth of perspective to the most overhyped term in healthcare right now. In this episode, we cut through the noise on AI. Manish challenges the very language we use, explaining why most of what gets called "AI" is really machine learning, why large language models are fundamentally not intelligent and why that distinction has very real consequences when lives are on the line. We look at where AI genuinely adds value in healthcare, from radiology to NHS administrative workflows, and where it is being dangerously overhyped, including some very pointed thoughts on using consumer-grade LLMs to make clinical diagnoses. We also explore how clinicians should think about AI as an augmenter rather than a replacement, why the productivity gains are real and where Manish believes the biggest untapped opportunity in healthcare actually sits. He closes with a frank take on what impressive AI looks like in a real clinical environment versus a polished demo and why the world is heading toward a very small group of people who truly understand what is happening under the hood. Thanks for tuning in to Episode 99. Don't forget to subscribe and check the show notes to learn more about Manish's work at Jiva.ai and his advisory role shaping UK AI policy in healthcare. Timestamps [00:00:28] From the Human Genome Project to Machine Learning: Manish's Academic Origins [00:02:09] AI Has Been Around Since the 1950s: The History Most People Don't Know [00:04:09] Why Tacking "AI" onto Your Product Name Is a Problem [00:05:24] Where Healthcare AI Really Is: Step Three Not Step 100 [00:06:06] Why Using Grok for Medical Diagnosis IsDangerous [00:09:48] Should Clinicians Be Scared AI Will Take Their Jobs?[00:12:18] How to Actually Start Learning About AI: Where to Begin [00:14:01] Writing the Book on AI Agents in 2011 [00:18:04] The Biggest Untapped Opportunity: Administrative AI Not Diagnostic AI [00:20:40] What Real Clinical AI Success Looks Like vs a Polished Demo Connect with Manish- ⁠⁠https://www.linkedin.com/in/manish-patel/ Learn more about Jiva ai - ⁠⁠⁠https://jiva.ai/ Get in touch with Karandeep Badwal - ⁠⁠⁠⁠⁠⁠⁠⁠https://www.linkedin.com/in/karandeepbadwal/ ⁠⁠⁠⁠⁠⁠⁠⁠ Follow Karandeep on YouTube - ⁠⁠⁠⁠⁠⁠⁠⁠https://www.youtube.com/@KarandeepBadwal⁠⁠⁠⁠⁠⁠⁠
March 23 · 25 min
#98 The Hidden Cost of Bad MedTech Strategy: Women’s Health, Reimbursement and What Founders Miss with Jordan Pollack
Jordan Pollack, biomedical engineer, entrepreneur and CEO of Sub-Q Bionics. Jordan began his career at Boston Scientific, later founded VeinWay in Israel and is now focused on building a new treatment paradigm for lymphoedema in cancer survivors. In this episode, we explore what actually creates momentum in MedTech, from networking with intent to building the resilience needed to survive the founder journey. Jordan shares why conferences alone rarely deliver results, how warm introductions and targeted roadshows outperform generic networking and what he had to unlearn after leaving corporate structure behind to become a startup CEO. He also offers a brutally honest take on entrepreneurship, explaining why the role is not for everyone and why persistence, resilience and equanimity matter more than titles or ambition alone. We also go deep into the story behind Sub-Q Bionics and why Jordan chose to focus on lymphoedema, particularly in women recovering from cancer treatment. He explains the clinical reality of the disease, the lack of meaningful treatment options beyond maintenance, and why reimbursement, not just good technology, is often the deciding factor in whether a device company succeeds. Along the way, he shares sharp insights on women’s health being chronically underfunded, the differences between the U.S. and Israeli startup ecosystems, and why mission-led companies are far more likely to stay the course when things get hard. Timestamps [00:00:32] Why Generic Conferences Rarely Create Real MedTech Opportunity [00:02:05] How Networking Shaped Jordan’s Move from Boston Scientific to Israel [00:03:29] What Corporate MedTech Taught Him and What He Had to Unlearn [00:05:54] Why Being a Founder Is Not for Everyone [00:08:49] The Origin of Sub-Q Bionics and the Shift Toward True Disease Treatment [00:11:53] What Lymphoedema Actually Is and Why It Is So Devastating [00:14:06] Why Women’s Health Remains Underfunded and Where Innovation Is Emerging [00:18:25] Why Reimbursement Matters More Than Technology Alone [00:20:58] U.S. vs Israel: Two Very Different Startup Ecosystems [00:25:10] Balancing Founder Life, Health, Travel and Relationships Connect with Jordan - ⁠https://www.linkedin.com/in/jordan-pollack-81464827/ Learn more about Sub-Q Bionics - ⁠⁠https://subqbionics.com/ Get in touch with Karandeep Badwal - ⁠⁠⁠⁠⁠⁠⁠https://www.linkedin.com/in/karandeepbadwal/ ⁠⁠⁠⁠⁠⁠⁠ Follow Karandeep on YouTube - ⁠⁠⁠⁠⁠⁠⁠https://www.youtube.com/@KarandeepBadwal⁠⁠⁠⁠⁠⁠⁠ Subscribe to the Podcast
March 9 · 23 min
#97 Beyond Ablation For Pain Management: Diagnostic-First FDA Strategy, Dual-Use Electrodes and the The Next Wave of Neurotechnology with Dave Rosa
Dave Rosa, CEO and President of NeuroOne, medtech entrepreneur, board member and former executive at St. Jude Medical, Boston Scientific and C.R. Bard. With three decades in medical devices and more than $200 million raised, Dave brings a rare mix of operator, inventor and capital markets experience to the future of neurotechnology and pain care. In this episode, we unpack one of the biggest mistakes medtech companies make: building technology without enough real-world user feedback. Dave explains why innovation for the sake of innovation often fails, especially in larger companies, and why the best products are shaped by how physicians and patients actually use them. We also explore NeuroOne’s unique approach of combining diagnostics and therapeutics through the same electrode, and why that kind of multifunctional platform thinking can be both clinically powerful and commercially strategic. A major theme in this conversation is regulatory strategy. Dave walks through NeuroOne’s deliberate “diagnostic first, therapeutic second” FDA pathway, explaining why starting with an easier regulatory indication can de-risk the technology, shorten timelines and create a stronger platform for later therapeutic claims. We also discuss the value of reusing the same generator across multiple indications, how founders often wait too long to engage with FDA, and why platform leverage matters from both a business and development perspective. We also go deep on chronic pain and lower back pain. Dave shares why today’s pain solutions often fall short, how different triggers require different treatment approaches, and where technologies like ablation, stimulation and smarter electrode design could shift outcomes. He also highlights how seemingly small user-experience issues, like frequent recharging, can destroy patient adherence and wipe out billions in company value. Timestamps [00:00:08] Why MedTech Companies Fail When They Ignore Real User Feedback [00:02:04] Innovation vs Iteration: When “New” Adds No Real Value [00:02:22] Combining Diagnostics and Therapeutics With the Same Electrode [00:03:52] Why NeuroOne Chose a Diagnostic-First FDA Strategy [00:05:21] Pain Management Today: Ablation, Stimulation and Complex Back Pain [00:08:21] What Is Fundamentally Broken in Lower Back Pain Solutions [00:09:26] How Small Patient Frictions Can Destroy Adoption and Valuation [00:11:11] The Power of Reusing the Same Generator Across Multiple Indications [00:13:00] The FDA Mistake Many Founders Still Make [00:21:15] Where Neurotechnology and Pain Management Are Heading Next Connect with Dave - https://www.linkedin.com/in/daverosa/ Learn more about NeuroOne - ⁠https://nmtc1.com/ Get in touch with Karandeep Badwal - ⁠⁠⁠⁠⁠⁠https://www.linkedin.com/in/karandeepbadwal/ ⁠⁠⁠⁠⁠⁠ Follow Karandeep on YouTube - ⁠⁠⁠⁠⁠⁠https://www.youtube.com/@KarandeepBadwal⁠⁠⁠⁠⁠⁠ Subscribe to the Podcast
February 23 · 24 min
#96 Decentralising Healthcare: Hospital Buying, AI as Augmented Intelligence and Clinical Adoption with Dr. Amel Havkic
Dr. Amel Havkic, founder of EvoMed Consulting and a lung and critical care specialist, hospital clinical lead. Amel works at the intersection of bedside medicine and MedTech strategy, helping innovators build clinician-approved solutions that scale safely across real healthcare systems. In this episode, we unpack why “clinicians love it” is rarely enough to win adoption, and what hospital purchasing actually looks like when procurement, IT, finance, compliance and workflows all have a seat at the table. Amel breaks down why switching away from legacy tools is painful, how integrations can break care pathways, and why solutions that feel like a natural part of the hospital ecosystem win faster. He also shares a practical lens for building frictionless implementation by aligning with standards like HL7, FHIR and DICOM, while proving measurable value for patients and payers. We also go deep on decentralising healthcare. Amel explains how the Dutch model centralises high-end expertise while decentralising access through remote monitoring and home-based onboarding, and why this becomes a winning approach as staffing pressures rise. On AI, he makes the case for reframing it as augmented intelligence, not autonomy, and shows where decision support can raise the baseline of care by supporting clinicians in time-critical situations, as well as offloading admin burden that drains capacity. Finally, Amel shares the thinking behind the EMC StarMap framework, a navigation tool built from real-world patterns of what makes MedTech succeed or fail. His core message is simple: regulatory approval is a milestone, but clinical adoption is the real finish line. Timestamps [00:00:05] Clinician + Consultant Lens: Seeing Adoption and Safety Risks [00:01:22] Why “Physicians Love It” Does Not Mean Hospitals Will Buy [00:03:27] What Hospitals Consider Beyond Cost: Workflow, Integration and Training [00:05:09] Frictionless Implementation: Standards, EHR Fit and “Team Player” Products [00:06:24] Real Clinical Workflow: ICU Reality and Why UI Clicks Matter [00:07:31] Decentralising Care: Centralised Expertise With Home-Based Delivery [00:10:37] AI in Healthcare: Reframing as Augmented Intelligence [00:12:55] Staffing Shortages: Where AI Can Remove Waste and Scale Expertise [00:14:38] If You Could Change One Thing: Put the Patient Back at the Center [00:16:59] StarMap: Measuring What Drives Clinical Adoption Connect with Amel - ⁠⁠⁠⁠https://www.linkedin.com/in/a-havkic/ Learn more about Evomed Consulting - https://evomed-consulting.eu/ Get in touch with Karandeep Badwal - ⁠⁠⁠⁠⁠https://www.linkedin.com/in/karandeepbadwal/ ⁠⁠⁠⁠⁠ Follow Karandeep on YouTube - ⁠⁠⁠⁠⁠https://www.youtube.com/@KarandeepBadwal⁠⁠⁠⁠⁠ Subscribe to the Podcast
January 12 · 27 min
#95 The Future of Acne Treatment: At Home Injections, Teledermatology and Building ClearPen with Rick Bente
Rick Bente, co-founder and CEO of Indomo, the company behind ClearPen, an investigational at home corticosteroid injection for inflammatory acne. Rick brings over two decades of experience in drug delivery and diagnostics with previous roles at Medtronic, Insulet and YourBio. In this episode we trace Rick’s journey from insulin pumps, large volume wearable injectors and remote blood collection to tackling one of the most common yet under-served conditions in medicine: acne. Rick explains why dermatology has seen far less innovation than fields like diabetes, why 40 percent of acne sufferers in the US live with deep inflammatory lesions that topicals simply cannot reach and how ClearPen aims to replicate in-clinic injections safely in the home. We dig into how dermatologists and GPs perceive acne severity, the mental health burden of adult acne and why telehealth has become a critical tool when wait times to see a dermatologist can exceed three months. Rick also unpacks the technical and regulatory complexity of combination products, from tying drug and device design histories together to generating RCT-grade evidence that satisfies regulators, payers and prescribing physicians. Finally, we talk about the realities of building a direct-to-patient model in a regulated market, balancing unmet patient need with the gatekeeping role of clinicians and insurers, and Rick’s own transition from corporate engineer to founder. He shares candid lessons on focusing beyond the patient to the full healthcare ecosystem, designing devices that are “hard to misuse” and why turning ideas into reality ultimately requires taking the leap. Timestamps [00:00:21] From insulin pumps and wearables to dermatology and ClearPen [00:02:27] Why acne and dermatology have been under-innovated compared to other MedTech fields [00:05:25] Acne beyond teenagers: genetics, adult breakouts and mental health impact [00:07:16] How dermatologists versus GPs understand acne severity and burden [00:09:27] Typical US acne care pathway and why Accutane was the last big breakthrough [00:11:54] Using telehealth to address three-month dermatologist wait times [00:15:16] Investigational at-home corticosteroid injections and designing for safe use [00:17:21] Biggest technical and regulatory challenges in drug-device combination products [00:19:59] Where founders go wrong with direct-to-patient models in healthcare [00:24:13] Moving from engineer to founder and building around value inflexion points Connect with Rick - ⁠⁠⁠https://www.linkedin.com/in/rick-bente/ Learn more about Indomo - ⁠⁠⁠https://www.linkedin.com/company/indomotx/ Get in touch with Karandeep Badwal - ⁠⁠⁠⁠https://www.linkedin.com/in/karandeepbadwal/ ⁠⁠⁠⁠ Follow Karandeep on YouTube - ⁠⁠⁠⁠https://www.youtube.com/@KarandeepBadwal⁠⁠⁠⁠ Subscribe to the Podcast
Dec 22, 2025 · 24 min
#94 Reinventing Continuous Glucose Monitoring (CGM): Molecular Wearables, Micro Sensors and Building SAVA with Renato Circi
Renato (Ren) Circi, co-founder of SAVA, a London based MedTech company building a new generation of minimally invasive continuous glucose monitors and molecular wearables. In this episode we rewind to the underground labs at Imperial College London where Ren and his co-founder Raph first immersed themselves in biosensors and began questioning the status quo of health monitoring. Ren explains how their shared obsession with measuring the body more effortlessly led to SAVA’s founding and what it really looks like to push through years of scientific failure in order to build a complex medical device platform. We dive into why SAVA manufactures everything in-house, how their micro sensor architecture differs from traditional filament based CGMs and why controlling every layer from chemistry to algorithms is essential if you want to iterate fast on performance. Ren sets out SAVA’s long term vision of continuous molecular tracking for everyone, not just people with diabetes, and what could be unlocked once you can monitor many molecules in real time from a single patch. We also talk about regulatory expectations for CGMs, the reality of one way product decisions in medical devices and the difficulty of fundraising for a consumer facing yet highly regulated deep tech company. Ren closes with candid reflections on what he would do differently, how he protects time for family and why working on a problem you truly care about with people you genuinely like is the only way to survive the journey. Timestamps [00:00:21] Origins at Imperial and discovering biosensors [00:01:59] Long horizons, repeated failure and staying in the game [00:03:56] Why SAVA manufactures everything in-house [00:06:46] How SAVA’s micro sensor CGM platform actually works [00:09:36] From diabetes to universal molecular health monitoring [00:12:02] Patient experience and CGM adoption in healthcare systems [00:13:43] When CGMs become cheaper than finger-pricks [00:15:15] Misconceptions about CGM and continuous molecular sensing [00:17:21] Why building CGMs is one of the hardest engineering challenges [00:22:54] Fundraising in unconventional deep tech MedTech and advice for founders Connect with Ren - ⁠⁠https://www.linkedin.com/in/circi/⁠ Learn more about Sava - ⁠⁠https://www.sava.health/ Get in touch with Karandeep Badwal - ⁠⁠⁠https://www.linkedin.com/in/karandeepbadwal/ ⁠⁠⁠ Follow Karandeep on YouTube - ⁠⁠⁠https://www.youtube.com/@KarandeepBadwal⁠⁠⁠ Subscribe to the Podcast
Dec 9, 2025 · 25 min
#93 How QMSR Is Reshaping U.S. MedTech: ISO 13485, FDA Inspections and AI in Auditing with Dr. Yuan Li
Dr. Yuan Li, Director of Medical Business at DQS and a former medical device auditor with deep expertise across orthopaedic manufacturing and regulatory systems. In this episode, we discuss the sweeping regulatory transition coming to the U.S. with the introduction of the Quality Management System Regulation (QMSR), which formally aligns 21 CFR Part 820 with ISO 13485. Yuan unpacks what this shift means for U.S.-based manufacturers, why FDA is phasing out the QSR audit model and why contract manufacturers and software-based device firms are particularly vulnerable if they delay planning. We also explore the growing use of AI in QMS platforms, the pitfalls of template-driven compliance, and why “regulatory fatigue” is no excuse when patients’ lives are at stake. From post-market surveillance strategies to paperless QMS migrations and the validation grey zone, Yuan offers pragmatic, deeply informed advice for those navigating FDA audits, ISO certification and international expansion Timestamps [00:02:36] Why QMSR is a Big Deal for U.S. Manufacturers [00:04:09] Key Differences Between 21 CFR 820 and ISO 13485 [00:05:09] Why Companies Wait Too Long to Comply [00:07:19] Impact on Contract Manufacturers and Supply Chains [00:08:36] Do You Really Need ISO 13485 Certification? [00:10:18] AI-Generated QMS Systems: Useful or Risky? [00:11:52] Most Memorable Audit Story: Iterative Design Gone Wrong [00:14:46] How to Spot Proactive vs Reactive Post-Market Surveillance [00:17:03] Why Software Companies Struggle with The Regulatory Mindset [00:20:57] What Validation Really Means Under ISO 13485 Connect with Yuan - ⁠https://www.linkedin.com/in/yuan-li-phd-3bb14013/ Learn more about DQS - ⁠https://www.dqsglobal.com/en/ Get in touch with Karandeep Badwal - ⁠⁠https://www.linkedin.com/in/karandeepbadwal/ ⁠⁠ Follow Karandeep on YouTube - ⁠⁠https://www.youtube.com/@KarandeepBadwal⁠⁠ Subscribe to the Podcast
Nov 24, 2025 · 29 min
#92 From NASA to SaMD: Building Galen Data with Chris DuPont: Risk, Resilience & Regulatory Realities
Chris DuPont, a seasoned MedTech engineer, entrepreneur, and co-founder of Galen Data, which was acquired by Matrix One in late 2024. With a background in aerospace software from NASA and a career dedicated to medical device connectivity, Chris shares a rare behind-the-scenes look at starting a cloud platform with just $600, scaling it into an FDA compliant infrastructure solution and navigating both technical and financial risk. In this episode, we dive into the unexpected similarities between outer space and inner space, how “Twiddler Syndrome” inspired a connected care solution and why the future of SaMD relies on proactive, cybersecure, cloud native design. Chris opens up about managing through the SVB collapse, regulatory war stories from his days at Cyberonics, and what he learned about entrepreneurship that no incubator can teach. From minimal viable features to medical-grade quality systems, this episode is packed with real lessons from a founder who’s seen it all. Timestamps [00:01:05] From Space Station Freedom to Inner Space: NASA to MedTech [00:02:56] Launching Galen Data with Just $600 [00:06:21] Why They Built Their Own Incubator [00:08:36] Fundraising in a Non-VC Town (Houston) [00:11:33] The Silicon Valley Bank Collapse and Business Risk [00:16:25] Twiddler Syndrome and the Birth of a Connected Platform [00:19:35] Cybersecurity and Compliance in the Cloud [00:22:20] FDA Approval Without Reimbursement: A Regulatory War Story [00:24:32] Why Not Every Feature Deserves to Ship [00:29:13] “You Can’t Fake Science”: Betting on Yourself in MedTech Connect with Chris - https://www.linkedin.com/in/chris-dupont-38b5ba15/ Learn more about MatrixOne - https://matrixone.health/ Get in touch with Karandeep Badwal - ⁠https://www.linkedin.com/in/karandeepbadwal/ ⁠ Follow Karandeep on YouTube - ⁠https://www.youtube.com/@KarandeepBadwal⁠ Subscribe to the Podcast
Nov 3, 2025 · 25 min
#91 Ending Trial and Error Cancer Care with Jim Foote: Functional Precision Medicine, AI and Personalised Oncology
Jim Foote, CEO and Founder of First Ascent Biomedical a pioneer in functional precision medicine (FPM) that aims to eliminate guesswork from cancer treatment. After losing his son to cancer, Jim left a career in cybersecurity to build a data-driven platform that combines AI, robotics and real-time tumour testing to help doctors choose the right therapy for each patient. In this episode, we explore how FPM differs from traditional genomics-only testing, why tumours can respond differently even with the same patient and how AI can support rather than replace clinicians in treatment decisions. Jim also shares the economic impact of ineffective therapies, the challenges of scaling regulatory innovation in oncology, and why the future of cancer care depends on personalisation at the  cellular level. Timestamps: [00:00:45] What Is Functional Precision Medicine? [00:02:00] Jim’s Personal Journey from Tech to Healthcare [00:05:50] Overcoming Regulatory and Systemic Gatekeepers [00:08:13] From Reactive Care to Personalised Treatment [00:09:08] What Lab Findings Reveal about Cancer Cells [00:10:30] Why Genomics Alone Isn’t Enough [00:12:03] AI as Decision Support Not a Decision Maker [00:15:55] Cancer in Younger Populations and Misconceptions [00:20:25] Reducing Cost and Waste in Cancer Treatment [00:26:34] What Success Really Means to Jim Foote Connect with Jim - https://www.linkedin.com/in/jim-foote/ Learn more about First Ascent Biomedical - https://www.linkedin.com/company/firstascentbio/ Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/ Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal Subscribe to the Podcast
Oct 22, 2025 · 25 min
#90 The Metabolic Signal You’re Probably Ignoring with Jari Närhi: NAD Testing, Longevity & Cellular Health
Jari Närhi, Co-Founder and CEO of NADMED, a University of Helsinki spin-out revolutionising how we understand and monitor NAD levels. With a background in mechanical engineering and a career spanning medtech, diagnostics and hospital operations, Jari brings a unique systems-level view on cellular health and innovation in clinical testing. In this episode, we explore why NAD (nicotinamide adenine dinucleotide) is so vital for human health, from fuelling ATP production to supporting DNA repair and immune regulation. Jari breaks down the science of NAD+, NADH and glutathione and why traditional lab methods like mass spectrometry have long failed to make NAD testing practical or scalable. We discuss the real-world impact of measuring NAD levels, from chronic illness to long COVID, and how this simple test could become as common as checking haemoglobin in the future. Jari also opens up about NADMED’s regulatory journey, the ethical dilemmas of DIY supplementation, the rise of longevity tech, and how AI will transform personalised diagnostics through pattern recognition in metabolic biomarkers Timestamps: [00:00:45] Age vs Disease: What Really Impacts NAD Levels [00:02:28] Why NAD Is Essential for Life [00:03:52] How NAD Decline Signals Deeper Health Issues [00:05:05] From Niacin to NAD: Understanding the B3 Pathway [00:06:00] CE‑Marking and Regulatory Hurdles for Diagnostics [00:06:59] How NADMED Made Testing Faster and More Accessible [00:09:02] The Ethics of Supplementation Without Testing [00:10:16] The VC Path: Funding Deep‑Tech MedTech Innovation [00:14:02] Metabolic Fingerprints and Personalised Medicine [00:17:11] AI, Data and the Future of Longevity Diagnostics Connect with Jari - https://www.linkedin.com/in/jari-n%C3%A4rhi-38b44/ Learn more about NADMED - https://www.nadmed.com/ Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/ Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal Subscribe to the Podcast
Oct 6, 2025 · 27 min
#89 Reframing Fertility with Kirsten Karchmer: AI, Cycle Health, and FemTech’s Untapped Potential
Kirsten Karchmer, founder of Conceivable, is one of North America's first reproductive acupuncturists. With a career spanning clinical practice, software development and AI integration, Kirsten brings a fresh, deeply personal perspective to the future of women’s health In this episode, we explore the root causes of infertility and why simply timing intercourse isn’t enough. Kirsten breaks down the concept of the “Conceivable Cycle,” how subclinical symptoms reveal deeper fertility issues, and why most women are misled by generic wellness advice. She also shares the story behind building an AI-powered virtual care platform, one designed not to replace doctors, but to give millions of women access to tools that previously cost tens of thousands in clinical care. We also talk about IVF, when it should be used, and how even women in their 40s can significantly boost fertility outcomes by improving internal health metrics. The conversation ends with Kirsten’s advice to female founders, the role of automation and AI in running a business and how her unexpected obsession with houseplants helps restore balance in a founder's high-stress life Timestamps: [00:00:45] From MS Diagnosis to Reproductive Medicine [00:02:26] Why Fertility Monitors May Be Doing More Harm Than Good [00:04:22] How to Actually Know If You’re Fertile [00:05:00] What the “Conceivable Score” Reveals [00:07:04] Building an AI OS for Women’s Health [00:10:15] Signs of a Healthy vs. Unhealthy Menstrual Cycle [00:13:46] When IVF Makes Sense and When It Doesn’t [00:16:03] Fertility After 35: Misconception or Reality? [00:18:00] The Resistance (and Reception) from Clinicians [00:21:02] Advice for Female Founders and Women in FemTech Get in touch with Kirsten - ⁠https://www.linkedin.com/in/kirsten-karchmer-0139808/ ⁠ Learn more about Conceivable - ⁠https://conceivable.com/⁠ Get in touch with Karandeep Badwal - ⁠https://www.linkedin.com/in/karandeepbadwal/ ⁠ Follow Karandeep on YouTube - ⁠https://www.youtube.com/@KarandeepBadwal⁠ Subscribe to the Podcast
Sep 1, 2025 · 27 min
#88 Hydrogel Tech and Lab Automation with Sinan Golhan: Hydrogel Robotics, Startup Fundraising and Battlefield Medicine
Sinan Gölhan, Founder and CEO of GelTech is helping scientists develop life-saving hydrogel treatments faster through automation. From cancer-fighting gels to battlefield-ready biomaterials, Sinan’s journey fuses deep technical insight with an intensely personal mission. In this episode, we talk about why hydrogels, the “Jell-O of medicine”, are so important in modern biotech, and how Sinan’s frustration with repetitive lab work led him to build robotic systems to accelerate testing. He shares hard-won lessons from early fundraising, what labs get wrong about automation, and how he turned rejection into resilience. We also dive into the world of battlefield bleeding control, nanotech-based drug delivery, and the future of AI-driven materials science. Timestamps: [00:00:18] What Are Hydrogels and Why They Matter [00:02:30] A Personal Mission: Cancer, Family and Science [00:04:45] From Lab Frustration to Robotic Innovation [00:06:33] Fundraising Real Talk: Angels, Grants, and Grit [00:10:42] How GelTech’s Platform Actually Works [00:13:33] Hydrogels in Your Fridge and in the OR [00:14:54] Why Lab Automation Isn’t a Luxury [00:16:23] The Coming Wave of Smart Materials [00:20:11] Battlefield Nanotech: Bleeding Control with Gels [00:27:25] Advice to Founders: Obsession, Vision and Persistence Get in touch with Sinan - https://www.linkedin.com/in/sinan-g%C3%B6lhan-a49691b6/ Learn more about Exagen - https://www.geltechlabs.com/ Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/ Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal Subscribe to the Podcast
Aug 5, 2025 · 29 min
#87 Diagnosing the Undiagnosable with Dr. Brittany Partain: T-Cell Biomarkers, Clinical Trust and Women in Biotech
Dr. Brittany Partain, Associate Director of Clinical Affairs and Physician Education at Exagen has a background in biomedical engineering and a passion for problem-solving, Brittany has carved out a unique role at the intersection of diagnostics, clinical education and biotech innovation In this episode, we explore why autoimmune diseases like lupus and rheumatoid arthritis are so difficult to diagnose, and how Brittany is helping close that gap through physician education and the use of novel T-cell biomarkers. We also talk about building trust with clinicians, misconceptions around diagnostic tools, and the real challenges of advancing innovation in a field that’s historically lagging behind specialities like oncology. Finally, Brittany reflects on her journey as a female leader in MedTech, the importance of collaboration, and why passion matters when navigating a fast-paced, highly regulated industry Timestamps: [00:00:45] Why Autoimmune Diseases Are So Difficult to Diagnose [00:01:55] From Biomedical Engineering to Clinical Affairs [00:04:34] Why Rheumatology Has Lagged Behind [00:07:07] How T-Cell Biomarkers Work and What They Solve [00:09:18] What Autoimmune Diseases Are and How They Present [00:11:05] Common Misconceptions Among Clinicians [00:13:00] How Hospitals and Private Clinics React to New Tools [00:15:07] Building Clinical Trust Through Science [00:18:05] What Most People Don’t Know About Autoimmune Disease [00:21:58] Women in Biotech: Breaking Stereotypes and Leading Change Get in touch with Brittany - https://www.linkedin.com/in/brittany-d-partain Learn more about Exagen - https://exagen.com/ Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/ Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal Subscribe to the Podcast
Jul 22, 2025 · 29 min
#86 Sepsis, Speed and Saving Lives with Dr. Rolland Carlson: Gene Signatures, Clinical Trials, and the Future of Infection Detection
Dr. Rolland “Rollie” Carlson, CEO of Immunexpress is a veteran of the molecular diagnostics space. With over 25 years of leadership across Abbott, WaferGen, Asuragen, and more, Rollie is now focused on solving one of healthcare’s most urgent crises: Sepsis. In this episode, we explore why sepsis, despite causing more than 48 million deaths annually remains so poorly understood and misdiagnosed. Rollie breaks down why early detection is so difficult, how gene expression profiling can finally distinguish between infectious and non-infectious inflammation and the real-world barriers to clinical trial design, FDA approval and physician adoption. We also cover military use cases, the lack of gold standards in sepsis diagnostics and what needs to change in how hospitals are incentivised to tackle this condition Timestamps: [00:00:26] Why Sepsis Remains Underdiagnosed Globally [00:01:42] What Sepsis Actually Is and Why It's So Deadly [00:03:14] Who’s Most at Risk: Age, Immunity, and Beyond [00:04:25] Detecting Sepsis Through Gene Expression [00:05:39] Why Blood Cultures Aren’t Enough Anymore [00:09:14] FDA Approval Without a Gold Standard: The Regulatory Maze [00:12:39] Sepsis Isn’t Always Bacterial and Why That Matters [00:15:20] How Physicians Are Reacting to New Molecular Tools [00:17:35] Beyond Sepsis: Expansion Into Infectious Diseases [00:18:57] From Marine Biologist to Diagnostics Pioneer Get in touch with Rollie - https://www.linkedin.com/in/rollie-carlson-ph-d-059074a/ Learn more about Immunexpress - https://immunexpress.com/ Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/ Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal Subscribe to the Podcast
Jul 8, 2025 · 28 min
#85 Under the Skin with Martin Burns: Bedsores, Biology-Based Prevention & The Hidden Cost of Inaction
Martin Burns, CEO of Bruin Biometrics is a former management consultant who worked with Deloitte and PwC and has also served as a guest lecturer at UCLA Anderson School of Management, where he taught entrepreneurship in biotechnology At Bruin, Martin is leading the charge to bring pressure injury (bedsore) prevention into the 21st century. Bedsores are entirely preventable yet remain one of the most under-discussed threats in hospitals today, especially among patients with darker skin tones who are often overlooked by traditional visual assessments In this episode, Martin explains why a biology-first approach is needed to tackle these “silent killers,” the major cultural and systemic hurdles to adoption, and why he believes sensor technology should become as routine as checking blood oxygen levels. We also explore investor skepticism, the importance of diverse clinical validation and the operational realities of implementing new technologies in hospitals without disrupting workflows Timestamps: [00:00:18] What Are Pressure Injuries and Why They’re Deadly [00:02:12] The Moment Martin Saw the Real Problem [00:03:58] The Biology of Subepidermal Moisture [00:06:53] Turning a Science Project into a Scalable Product [00:10:06] Why Traditional Risk Assessments Fail [00:12:41] Addressing Skin Tone Bias in Wound Care [00:17:14] From Skepticism to Adoption: Changing Clinical Culture [00:21:55] Beyond Bedsores: Future Sensor Applications [00:24:17] The Nurse Assistant That Frees Up Hours [00:26:52] Mountains, Gym Days & Recharging Outside Work Get in touch with Martin - https://www.linkedin.com/in/martin-burns-9391a57/ Learn more about Bruin - https://sem-scanner.com/ Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/ Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal Subscribe to the Podcast