The MedTech Podcast

• #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 expansionTimestamps[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 13485Connect 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/@KarandeepBadwal⁠⁠Subscribe to the Podcast

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• #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 MedTechConnect 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/@KarandeepBadwal⁠Subscribe to the Podcast

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• #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 FooteConnect 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/@KarandeepBadwalSubscribe to the Podcast

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• #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 biomarkersTimestamps:[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 DiagnosticsConnect 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/@KarandeepBadwalSubscribe to the Podcast

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• #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 healthIn 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 lifeTimestamps:[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 FemTechGet 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/@KarandeepBadwal⁠Subscribe to the Podcast

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