Let's Talk Risk! Podcast

You cannot bolt cybersecurity onto a medical device at the end of development. FDA’s cybersecurity guidance makes a clear shift: cyber risk is now a quality system issue, a patient safety issue, and a lifecycle management issue. For connected and software-enabled devices, it is not enough to show that the software works as intended. Manufacturers also need to show how cybersecurity risks were iden...

Summary “The biggest takeaway was realizing that our perspectives on risk and safety are not isolated. They are shared, validated, and strengthened by others in the field.” In this special episode of the Let’s Talk Risk! conversation , host Naveen Agarwal brings together a panel of medtech safety and risk management leaders to discuss key takeaways from IMSC26 in Boston. The conversation highlight...

Summary “Stop thinking of AI as replacing humans. Think about humans staying in charge while AI is placed in the loop” Artificial intelligence is no longer a future concept in MedTech. It is already inside medical devices, quality systems, regulatory workflows, post-market processes, and product development decisions. In this episode of the Let’s Talk Risk Podcast , host Naveen Agarwal sits down w...

You cannot reverse engineer your human factors regulatory strategy at the 11th hour. FDA’s new human factors guidance is not just about what goes into a marketing submission. It changes the way teams need to think about use-related risk, critical tasks, labeling, training, post-market evidence, and design change control across the product lifecycle. In this audio case study, we walk through why Ca...

Summary “Tools do not remove uncertainty” In this Let’s Talk Risk! conversation , host Naveen Agarwal speaks with Vilma Nasteckiene, PhD , founder of Holistic Business Risk , about a broader and more human view of risk management. Vilma brings experience from banking, fintech, operational excellence, consulting, research, and business transformation. Her work focuses on reconnecting risk managemen...

Summary “Quality and risk people need to translate safety into business terms.” In this Let’s Talk Risk! conversation , host Naveen Agarwal speaks with Eric Sugalski about how MedTech professionals can communicate safety, risk, and innovation more effectively to senior leaders. Eric brings a broad product-development perspective across engineering, manufacturing, regulatory strategy, commercializa...

Summary “AI can be a powerful helper, but it should not be the decision-maker.” In this Let’s Talk Risk! conversation , host Naveen Agarwal speaks with David Grilli about how MedTech teams can use AI responsibly in product development without losing control of risk, quality, or accountability. David brings experience across medical device risk management, system safety, reliability engineering, an...

Summary “Compliance alone does not drive quality” In this Let’s Talk Risk! conversation , host Naveen Agarwal speaks with Mike Cook about the the Voluntary Improvement Program (VIP), and how it can help MedTech leaders go beyond inspection readiness toward true quality maturity. Mike explains how VIP grew out of FDA’s Case for Quality initiative, why the program uses a maturity-appraisal model rat...

Summary “FDA isn’t just inspecting procedures anymore. They are looking at how risk-based decisions are actually made.” In this episode of the Let’s Talk Risk Podcast , host Naveen Agarwal speaks with Michelle Lott about what early FDA 483 observations under QMSR are already revealing: a clear shift from procedural compliance to evaluating how well companies actually make risk-based decisions acro...

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...