Let's Talk Risk! Podcast
Let’s Talk Risk! brings together MedTech leaders and practitioners for thoughtful conversations on the challenges that shape risk, quality, innovation, and leadership. With 150+ episodes and more than 30K downloads, it helps professionals gain the clarity and confidence to lead through complex decisions. naveenagarwalphd.substack.com
All episodes(25)
- StandardSummaries onlyLTR 152: Omar Al Kalaa on Telesurgery and the Future of Remotely Controlled Medical Systems
Published Apr 24, 2026
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 therapy, these technologies are expanding what is possible in patient care—but they also introduce a very d
- StandardSummaries onlyLTR 151: Sarai Pahla on Managing Supply Chain Disruption Risk in Life Sciences
Published Apr 17, 2026
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 operations problem. It is a real risk issue for life sciences companies.Sarai brings a rare perspective
- StandardSummaries onlyCase Study: How Patient Preference Data Rescued a High-Risk Device
Published Apr 10, 2026
Case StudyImagine 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 executive team that the device failed to meet any traditional safety threshold.But what if the FDA didn
- StandardSummaries onlyLTR 150: Jonathan Kendler on Rethinking Human Factors Engineering for AI/ML-Enabled Devices
Published Apr 3, 2026
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 perspective to the discussion, blending decades of experience in user interface design, human factors, and m
- StandardSummaries onlyLTR 149: Lavanya Ramnath on Risk Analysis, IDE Strategy, and Patient-Centered Design
Published Mar 27, 2026
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 technology, SaMD, and closed-loop systems, Lavanya explains how regulatory, clinical, engineering, and usability
- StandardSummaries onlyLTR 148: Chris Daly on Companion Diagnostics, AI, and FDA’s Evolving Approach
Published Mar 20, 2026
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 whom.In this Let’s Talk Risk! conversation, host Naveen Agarwal sits down with Chris Daly to discuss how
- StandardSummaries onlyLTR 147: Richard Matt on Bringing Benefit–Risk Upstream in Design and Development
Published Mar 13, 2026
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 decisions are already locked, so risk management becomes cleanup, not guidance.His most valuable takeaway is
- StandardSummaries onlyLTR 146: Ganesh Sabat on Scaling MedTech Through Quality
Published Mar 6, 2026
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.Ganesh walks through SMT’s transformation from an innovative startup into a globally recognized cardiovascul
- StandardSummaries onlyLTR 145: Holly Cotter on Avoiding the QMSR Scramble with Smart Quality Planning
Published Feb 27, 2026
Smart Quality PlanningSummary“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 Podcast, host Naveen Agarwal sits down with Holly Cotter to talk about what this transition really mean
- StandardSummaries onlyLTR 144: Jean Blom on How Hazard-First Thinking Improves Risk Management
Published Feb 20, 2026
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 practical. We explore why many teams get stuck in the mechanics of risk tools (especially large, bottom-u
- StandardSummaries onlyLTR 143: Jennifer Mascioli-Tudor on Leading Proactive Quality in the QMSR Era
Published Feb 13, 2026
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, from companies that are fully prepared to those that haven’t started, and explains why being ISO 13485 cer
- StandardSummaries onlyLTR 142: Florian Tolkmitt on Clinical Evaluation, Risk, and the New ISO Draft Standard
Published Feb 6, 2026
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 clinical evaluation for medical devices.The conversation centers on the newly released draft ISO standard f
- StandardSummaries onlyLTR 141: Ashkon Rasooli on Applying an Agile Mindset to Risk-Based Quality Systems Under QMSR
Published Jan 30, 2026
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 hardware-centric quality thinking breaks down in software environments, where failures are deterministic,
- StandardSummaries onlyLTR 140: Pujitha Gourabathini on Connecting Risk Management and Design Controls
Published Jan 23, 2026
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 integrating risk management with design controls.Pujitha shares practical, experience-based insights on why risk f
- StandardSummaries onlyLTR 139: Steve Silverman on FDA Readiness for QMSR
Published Jan 16, 2026
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 acknowledges that the current environment inside the agency is marked by workforce reductions, loss of institu
- StandardSummaries onlyLTR 138: Michelle Lott on QMSR Readiness, Risk-Based Assurance and FDA Expectations
Published Jan 9, 2026
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 industry truly stands, highlighting a dangerous gap between awareness and action.The conversation explores ho
- StandardSummaries onlyLTR 137: Priya Setty on QMSR, Risk-Based Assurance, and Building a Future-Ready RA Career
Published Dec 19, 2025
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 product lifecycle. Priya shares how the FDA’s alignment with ISO 13485 elevates expectations for design c
- StandardSummaries onlyLTR 136: Adam Isaacs Rae on What QMSR Really Changes and What It Doesn't
Published Dec 12, 2025
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 consultant and a lead auditor for certification bodies. With trademark clarity and humor, he explains why focusi
- StandardSummaries onlyLTR 135: Allison Komiyama on Rethinking Benefit-Risk in MedTech
Published Dec 5, 2025
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 her ability to make complex FDA topics understandable and fun, Allison brings fresh clarity to one of the m
- StandardSummaries onlyLTR 134: James Pink on Responsible AI and Future of MedTech Safety
Published Nov 28, 2025
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 engineering and auditing, to his life-altering health experience that reinforced his passion for patient safet
- StandardSummaries onlyLTR 133: Megan Kane on Leading QMSR Readiness in MedTech Startups
Published Nov 21, 2025
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 explains how the shift from checklist compliance to process-based assurance challenges teams to think dif
- StandardSummaries onlyLTR 132: Bijan Elahi on Future of MedTech Safety and the 2026 Conference in Boston
Published Nov 14, 2025
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 Boston.Bijan shares the inspiring story of how a grassroots effort among passionate professionals has grown
- StandardSummaries onlyLTR 131: Rick Wedge on the Human Side of Safety Risk Management
Published Nov 7, 2025
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 career to depending on a glucose monitoring system to manage life without a pancreas. His story bridges
- StandardSummaries onlyLTR 130: Hannah Walter on Human Factors and Inclusive Design in Medical Devices
Published Oct 31, 2025
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 explains why human-machine interaction has become a critical design priority, and why early conversations
- StandardSummaries onlyLTR 129: Viral Thakkar on breakthrough innovation and the Lungpacer story
Published Oct 24, 2025
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 that helps patients on mechanical ventilators recover their natural breathing ability. Viral recounts how t