Let's Talk Risk! Podcast

Summary “The industry is aware of QMSR, but they’re not moving. Many are still holding their breath, hoping something will change.” In this episode of the Let's Talk Risk Podcast , host Naveen Agarwal is joined by Michelle Lott for a deep and practical discussion on QMSR readiness as FDA’s February 2026 deadline rapidly approaches. Michelle shares a sobering view of where the medical device indust...

Summary “FDA isn’t asking whether you followed the procedure. They are asking whether your system can assure consistent outcomes in the real world.” In this episode of the Let's Talk Risk Podcast , Priya Setty joins host Naveen Agarwal to unpack why QMSR represents more than a procedural update; it’s a mindset shift toward assurance, credibility, and risk-based decision making across the entire pr...

Summary “Under QMSR, FDA will still be FDA, but they’ll finally have broader authority to cite what they’ve always cared about.” In this Let’s Talk Risk! conversation , host Naveen Agarwal sits down with Adam Isaacs Rae to unpack one of the most misunderstood aspects of FDA’s new QMSR rule: the parts that aren’t changing. Adam brings a unique dual-lens perspective as both a medical device consulta...

Summary “We talk about risk all the time, but we forget to talk about the benefit. FDA’s job is to protect and promote public health, and benefit–risk is how those two missions meet.” In this episode of the Let's Talk Risk Podcast , host Naveen Agarwal sits down with Dr. Allison Komiyama , neuroscientist, former FDA reviewer, regulatory strategist, and founder of Bluestocking Health . Known for he...

Summary “With great power comes great responsibility. The innovation in AI is incredible, but our assurance models must catch up if we’re to keep patients safe” In this thought provoking Let’s Talk Risk! conversation , host Dr. Naveen Agarwal welcomes James Pink , a global leader in medical device safety, risk, and regulatory strategy. James shares his deeply personal journey, from clinical engine...

Summary “If you’re a small company and feel stuck in the QMSR transition, use that startup energy. Get creative, tap your network, and find the experts who can help you get unstuck.” In this episode of the Let's Talk Risk Podcast , Megan Kane joins host Dr. Naveen Agarwal to unpack what the FDA’s new Quality Management System Regulation (QMSR) means for startups and small MedTech companies. She ex...

Summary “This conference is really by the community and for the community - a place where people passionate about MedTech safety can come together to share ideas, learn, and make a difference.” In this Let’s Talk Risk! conversation , host Dr. Naveen Agarwal welcomes back renowned safety risk management expert Bijan Elahi to discuss the upcoming International MedTech Safety Conference 2026 in Bosto...

Summary “Be diligent, because one day, you might rely on the very device you helped design.” In this deeply personal and technically insightful episode of the Let's Talk Risk Podcast , host Naveen Agarwal speaks with Rick Wedge , a seasoned expert in risk management and design control for drug-device combination products. Rick shares his remarkable journey - from developing biosensors early in his...

Summary “Talk to the people you are building the device for. Assumptions may speed development, but they often miss the human realities that determine whether a product succeeds or fails.” In this Let’s Talk Risk! conversation , host Dr. Naveen Agarwal sits down with Hannah Walter to explore the human side of medical technology. From robotic surgery consoles to AR/VR-assisted procedures, Hannah ex...

Summary “You can’t walk away from risk. If people did, no one would ever develop a product this complex. The key is learning how to manage risk intelligently through data and a structured process.” In this episode of the Let's Talk Risk Podcast , host Dr. Naveen Agarwal sits down with Viral Thakkar , Chief Operating Officer of Lungpacer Medical, Inc. , to explore the inspiring story of a device th...

In this audio brief, we unpack a recent Class I recalls of the Boston Scientific Watchman TruSeal Access System . What began as a rare but catastrophic risk of air embolism evolved into a global procedural-safety lesson for the entire MedTech industry. Key themes: * Procedural vs. device risk: How the true hazard emerged from workflow variation, not product failure. * Scale-driven exposure: Commer...

Summary “Risk management is nothing without asking questions. And just as important, we need to create a culture where people aren’t afraid to ask them, because without that, everything grinds to a halt.” In this Let’s Talk Risk! conversation , host Naveen Agarwal welcomes Edward Ball, Manager of Intelligence and Strategic Execution at RQM+. Ed shares insights from his 20+ years in medical devices...

Summary “Ethical and compliant AI adoption isn’t a barrier to innovation. It makes your business stronger and more resilient.” In this Let’s Talk Risk! conversation , host Naveen Agarwal reconnects with longtime friend and Silicon Valley tech leader Ajay Dankar , Co-Founder of Trussed AI. Ajay shares insights from his career at Google, AWS, Adobe, and PayPal, and explains how generative and agenti...

In this audio brief, we unpack the practical implications of the FDA’s Final Guidance on Computer Software Assurance (CSA) , issued September 2025. The debate highlights two perspectives: * Quality professional’s view : CSA cuts unnecessary documentation, aligns validation with patient safety risk, and supports agile manufacturing. * Auditor’s view : CSA’s reliance on qualitative judgment, binary...

Summary “Compliance can’t just be a once-per-year audit anymore. It has to be continuous, proactive, and built into the way we work every day.” In this Let’s Talk Risk! conversation , Naveen Agarwal speaks with Adam Foresman , Co-Founder and CEO of Ryden Solutions, about building the first platform for continuous compliance gap analysis in the life sciences industry. Adam shares his journey from l...

Summary “EU MDR is the spiritual ancestor of the EU AI Act”. In this Let’s Talk Risk! conversation , host Naveen Agarwal welcomes Kevin Schawinski, astrophysicist turned AI entrepreneur and CEO of Modulos AG. Kevin shares his journey from studying black holes to building AI governance solutions, and explains how the EU AI Act is modeled after the EU Medical Device Regulation (MDR). He highlights t...

In this audio brief, We unpack an academic study that compares the EU’s MDCG 2019-16 and the FDA’s cybersecurity guidance , benchmarking them against international best practices. Both documents cover the basics, but each leaves troubling gaps, especially in areas like authentication, secure coding, network security, and resilience. Key points in this audio brief: * The biggest risks of connected...

Summary “Wireless coexistence is not a checkbox. It’s a risk management approach”. In this Let’s Talk Risk! conversation , Dr. Naveen Agarwal sits down with Omar Al Kalaa, PhD, Founder of Inovectrum and former FDA wireless scientist, to explore the challenges and opportunities of integrating wireless technology into medical devices. Omar shares his journey from academic research on wireless coexis...

Summary “Management listens when you connect patient risk to product requirements and business goals.”. In this Let’s Talk Risk! conversation , host Naveen Agarwal and Richard Matt delve into the complexities of communicating risk to senior executives. They explore the common challenges faced by risk practitioners in effectively conveying risks and the importance of framing these discussions in te...

Note: this is an updated version of the original article first published on Sep 8. It has been corrected for an error in the number of AI/ML enabled medical devices cleared by the FDA mentioned in the original article. In this audio brief, we unpack recalls data on AI/ML enabled medical devices to gain insights on emerging vulnerabilities from a risk management point of view. Here are a few key hi...

Summary “The PSUR should be a snapshot showing if your medical device is really safe, not just a 200-page report for auditors”. In this Let’s Talk Risk! conversation , host Naveen Agarwal sits down with Tibor Zechmeister, Head of Quality and Regulatory at Flinn.ai, to unpack the complexities of the Periodic Safety Update Report (PSUR) under EU MDR. They discuss key takeaways from the RAPS Euroconv...

This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.com Summary “Don’t wait. You need time not just to update your procedures, but to generate the records FDA will expect to see the day they walk through your door.” In this episode of the Let's Talk Risk Podcast , host Naveen Agarwal and Michelle Lott from Lean RAQA discuss the upcoming Quality Management System...

In this audio brief, we unpack the rapidly evolving AI regulatory landscape in the U.S. and EU. While the U.S. emphasizes rapid innovation with lighter-touch oversight, the EU is implementing a strict, risk-based framework. Here are a few key highlights * U.S. AI Action Plan (July 2025): Prioritizes speed, innovation, and global leadership; promotes a “try first” culture; frames AI as a national s...

Summary “The opportunities in India’s MedTech sector are tremendous. Start networking, join incubators and get involved!” In this Let’s Talk Risk! conversation , host Naveen Agarwal engages with Attrayee (Atty) Chakraborty, a quality systems engineer specializing in regulatory affairs. They discuss the rapidly evolving medical device landscape in India, the importance of networking for young profe...

This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.com Summary “In this world that is changing really fast, your greatest superpower is your ability to learn new things.” In this episode of the Let's Talk Risk Podcast , host Naveen Agarwal and guest Dr. Jay Vaishnav discuss the dynamic regulatory landscape in the MedTech industry, particularly focusing on AI-po...