Let's Talk Risk! Podcast

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...

In this audio brief, we unpack a recent Class I recall of Medtronic's Newport HT70 and HT70 Plus ventilators. These portable ventilators posed a grave risk—shutting down unexpectedly, potentially endangering patients on life support. But the story doesn't stop there. We take you inside the analytical process , examining over 2,000 adverse event reports from the FDA’s MAUDE database, and revealing...

Summary “When reviewing clinical evidence for off-label use, come up with a plan to systematically address it and build these processes into your SOPs.” In this Let’s Talk Risk! conversation , host Naveen Agarwal and Kristen Petersen discuss the complexities of off-label use in clinical evaluation, emphasizing its significance in the medical device industry. They explore the definitions, examples,...

Summary “You need to base your summary and conclusions based on facts, not assumptions. Work smarter, not harder.” In this Let’s Talk Risk! conversation , Dr. Queenita Fernandes shares her extensive experience in the healthcare industry, particularly in risk management and clinical evaluation. She emphasizes the importance of collaboration, leveraging technology, and the role of AI in enhancing cl...

FDA highlights the increasing relevance of cybersecurity in the context of medical device safety and effectiveness in the opening section of the final guidance issued on June 27, 2025: With the increasing integration of wireless, Internet- and network-connected capabilities, portable media (e.g., USB or CD), and the frequent electronic exchange of medical device-related health information and othe...

Summary “A major change proposed in the draft of ISO 10993-1 revision is the focus on foreseeable misuse and effect of cumulative device use for biological safety. ” In this Let’s Talk Risk! conversation , host Naveen Agarwal engages with Priyanka Murawala, an expert in biological evaluation of medical devices. They discuss the latest updates on ISO 10993-1, the differences in regulatory approache...

This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.com Summary “The EU MedTech Shark Tank helps bring new technology ideas on a roundtable, pitching in front of physicians and investors to support startups by creating a network.” In this episode of the Let's Talk Risk Podcast , host Naveen Agarwal speaks with Dr. Michael Lichtenberg about the challenges and opp...

Summary “MedTech in India is poised to generate $50 billion in revenues by 2030.” In this Let’s Talk Risk! conversation , host Naveen Agarwal engages with Sanjay Arudi, VP of Regulatory and Quality at GE Healthcare in India, to discuss the rapidly evolving MedTech environment in India. They explore the current state of the MedTech industry, government initiatives supporting healthcare, the regulat...

The DxI 9000 Access Immunoassay analyzer instrument and assays are used to diagnose serious conditions such as Hepatitis B and heart attacks, and to monitor levels of therapeutic drugs such as Digoxin used in treatment of heart failure and atrial fibrillation. In a recent warning letter, FDA cited several examples of incorrect severity assignments, Severity Rating has been incorrectly selected for...

Summary “The 2025 conference was held in Amsterdam and it really was an amazing success.” In this Let’s Talk Risk! conversation , host Naveen Agarwal engages with Bijan Elahi, a leading authority in medical device safety risk management. They discuss the recent 2025 International Medical Device Safety Risk Management conference held in Amsterdam, focusing on the evolution of patient-centric safety...