Let's Talk Risk! Podcast

Summary “Just having a policy in place is one thing. Having a QMS that aligns to it is the next.” In this Let’s Talk Risk! conversation , host Naveen Agarwal speaks with Sherita Black about one of the most challenging and often misunderstood topics in ISO 14971: creating a policy for risk acceptability. The conversation goes beyond the standard’s wording and gets into the practical questions that...

Summary “FDA is still asking the same core question here: can the sponsor demonstrate that the full system is safe and effective for the patient?” In this episode of the Let’s Talk Risk Podcast , host Naveen Agarwal sits down with Dr. Omar Al Kalaa to talk about one of the most important emerging frontiers in MedTech: remotely controlled medical systems. From telesurgery to connected infusion ther...

Summary “Loss of service or device is loss of benefit, which means it naturally increases the risk of our device.” What happens when a highly regulated medical device depends on a tiny, single-sourced component buried deep in a fragile global supply chain? In this Let’s Talk Risk! conversation , host Naveen Agarwal speaks with Dr. Sarai Pahla about why supply chain disruption is no longer just an...

Imagine you are running a pivotal clinical trial for a novel implant. The data comes back, and it is rough: 80% of your patients have suffered a serious adverse event, and 40% have developed acute kidney injury. If you are sitting in the regulatory or risk management seat, you are likely drafting the project’s post-mortem. In a traditional risk management paradigm, you are preparing to tell the ex...

Summary “AI brings novel risks and addressing them will require a more creative approach to human factors engineering.” In this Let’s Talk Risk! conversation , host Naveen Agarwal speaks with Jonathan Kendler, a seasoned medical device human factors and UI design consultant, about how artificial intelligence is changing the practice of usability engineering in MedTech. Jonathan brings a rare persp...

Summary “The clinical study is actually where your risk analysis is going to meet reality.” In this Let’s Talk Risk! conversation , host Naveen Agarwal speaks with Lavanya Ramnath , Senior Regulatory Affairs Specialist at Insulet, about what it really takes to prepare for an IDE and why early-phase risk work is far more than a documentation exercise. Drawing on her experience in diabetes technolog...

Summary “Test, test, test - and don’t accept the outcome unless you’re fairly confident in the level of uncertainty that remains.” Companion diagnostics (CDx) are inherently high-consequence because they can directly shape treatment decisions. That reality drives a higher bar for clarity: intended use boundaries, evidence expectations, and tight specificity in what the test is claiming and for who...

Summary “Look at how benefits and risks are allocated among different design options and pick a product architecture that minimizes risks and maximizes benefits.” In this Let’s Talk Risk! conversation , Richard Matt shares a simple but uncomfortable observation: most organizations do risk “correctly” on paper, but too late to matter. By the time the DFMEA/PFMEA is polished, key architecture decisi...

Summary “A company can become world class the day the quality team decides.” In this Let’s Talk Risk! conversation , host Naveen Agarwal engages with Ganesh Sabat, former former CEO of Sahajanand Medical Technologies (SMT) and now Founder & Managing Partner of MedArtha Capital about a simple but hard truth: global scale in MedTech is earned through quality execution, not marketing narratives. Gane...

Summary “You don’t want to be implementing QMSR while the FDA is waiting in the lobby.” As the FDA transitions from the Quality System Regulation (QSR) to the new Quality Management System Regulation (QMSR), confusion persists across the MedTech industry. Is ISO 13485 certification enough? Does MDSAP cover everything? What exactly will FDA inspectors expect? In this episode of the Let’s Talk Risk...

Summary “Risks occur. They happen but they don’t exist … hazards do.” In this Let’s Talk Risk! conversation , host Naveen Agarwal sits with Jean Blom , a QMS & Audit Specialist and risk management trainer with deep experience across ISO 13485 auditing, ISO 14971 risk management (including usability), and certification/accreditation perspectives. Our conversation is deliberately informal and highly...

Summary “Management review is no longer a check-the-box exercise. It’s the most powerful lever leaders have to drive proactive quality.” In this episode of the Let’s Talk Risk Podcast , Naveen Agarwal sits down with Jennifer Mascioli-Tudor , an experienced Quality and Regulatory leader, to unpack what QMSR readiness really means in practice. Jennifer shares what she’s seeing across the industry, f...

Summary “For years, clinical evaluations were mostly a story. What was missing were clearly defined outcome parameters, something measurable that connects the state of the art to benefit–risk conclusions.” In this Let’s Talk Risk! conversation , host Naveen Agarwal welcomes back Florian Tolkmitt , Managing Director of Pro-Liance Global Solutions, for a timely and highly practical discussion on cli...

Summary “Delaying a product that is adequately safe and effective is itself a risk, one we rarely acknowledge in our quality systems.” In this episode of the Let's Talk Risk Podcast , host Naveen Agarwal speaks with Ashkon Rasooli, a seasoned SaMD and AI/ML quality strategist, about what QMSR readiness really means for software-heavy medical device organizations. Ashkon explains why traditional ha...

Summary “Risk management should not be a compliance checkbox. It must actively govern design decisions and feedback loops across the product lifecycle.” In this Let’s Talk Risk! conversation , host Naveen Agarwal sits down with Pujitha Gourabathini , Quality Assurance and Risk Management leader at Becton Dickinson , to explore one of the most persistent challenges in MedTech: effectively integrati...

Summary “QMSR isn’t about regulatory obligation; it’s about managing business risk, protecting customers, and preserving market share.” In this episode of the Let's Talk Risk Podcast , host Naveen Agarwal is joined by Steve Silverman to explore a question that’s often left unspoken: Is the FDA ready for QMSR? Drawing on his experience as a former FDA leader and industry policy expert, Steve acknow...

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...