Let's Talk Risk! with Dr. Naveen Agarwal
BookmarkCasual and informal conversations about practical aspects of medical device risk management.
Let's Talk Risk! with Dr. Naveen Agarwal is a technology podcast hosted by Casual and informal conversations about practical aspects of medical device risk management.. It has 161 episodes, with the latest published April 2026.
Every Friday, Dr. Naveen Agarwal leads a Let's Talk Risk! conversation with industry colleagues to discuss practical challenges and share best practices in risk management. In the highly regulated world of medical devices, most practitioners struggle with the "how" of risk management. Regulatory requirements are complex, confusing and ever changing. Establishing an effective risk management process that satisfies the scrutiny of regulators and auditors without creating barriers to innovation is a significant challenge in the industry. Dr. Agarwal believes that no single "expert" has all the answers, and it is only when we connect, share and learn from each other that we all become better. Let us keep learning together! naveenagarwalphd.substack.com
technology ·en ·161 episodes
Case Study: How Patient Preference Data Rescued a High-Risk Device
LTR 150: Jonathan Kendler on Rethinking Human Factors Engineering for AI/ML-Enabled Devices
LTR 149: Lavanya Ramnath on Risk Analysis, IDE Strategy, and Patient-Centered Design
LTR 148: Chris Daly on Companion Diagnostics, AI, and FDA’s Evolving Approach
LTR 147: Richard Matt on Bringing Benefit–Risk Upstream in Design and Development
LTR 146: Ganesh Sabat on Scaling MedTech Through Quality
LTR 145: Holly Cotter on Avoiding the QMSR Scramble with Smart Quality Planning
LTR 144: Jean Blom on How Hazard-First Thinking Improves Risk Management
LTR 143: Jennifer Mascioli-Tudor on Leading Proactive Quality in the QMSR Era
LTR 142: Florian Tolkmitt on Clinical Evaluation, Risk, and the New ISO Draft Standard
LTR 141: Ashkon Rasooli on Applying an Agile Mindset to Risk-Based Quality Systems Under QMSR
LTR 140: Pujitha Gourabathini on Connecting Risk Management and Design Controls
LTR 139: Steve Silverman on FDA Readiness for QMSR
LTR 138: Michelle Lott on QMSR Readiness, Risk-Based Assurance and FDA Expectations
LTR 137: Priya Setty on QMSR, Risk-Based Assurance, and Building a Future-Ready RA Career
LTR 136: Adam Isaacs Rae on What QMSR Really Changes and What It Doesn't
LTR 135: Allison Komiyama on Rethinking Benefit-Risk in MedTech
LTR 134: James Pink on Responsible AI and Future of MedTech Safety
LTR 133: Megan Kane on Leading QMSR Readiness in MedTech Startups
LTR 132: Bijan Elahi on Future of MedTech Safety and the 2026 Conference in Boston
LTR 131: Rick Wedge on the Human Side of Safety Risk Management
LTR 130: Hannah Walter on Human Factors and Inclusive Design in Medical Devices
LTR 129: Viral Thakkar on breakthrough innovation and the Lungpacer story
Case Study: The WATCHMAN TruSeal Recall and the Hidden Risk of Procedural Variation
LTR 128: Edward Ball on AI, Vigilance and Future of MedTech Regulation
LTR 127: Ajay Dankar on Proactive AI Governance in MedTech
FDA CSA Debate: Streamlined Assurance or Audit Ambiguity?
LTR 126: Adam Foresman on Proactive Compliance and Future of MedTech
LTR 125: Kevin Schawinski on Building Trustworthy AI and MedTech Readiness
Case Study: Comparing EU and FDA Cybersecurity Guidance for Medical Devices
LTR 124: Omar Al Kalaa on Wireless Coexistence and Risk in Connected Medical Devices
LTR 123: Richard Matt on Effective Risk Communication
Case Study: What AI/ML Device Recalls Reveal About Emerging Risks
LTR 122: Tibor Zechmeister on PSUR Best Practices
LTR 121: Michelle Lott on Risk, CAPA and FDA Inspections under QMSR
Case Study: Contrasting U.S. and EU Approaches to AI Regulation
LTR 120: Atty Chakraborty on India's Rising MedTech Sector
LTR 119: AI, Risk and Regulatory Strategy with Dr. Jay Vaishnav
Case Study: When Clues to a Future Recall Hide in Plain Sight
LTR 118: Off-Label Use with Kristen Petersen
LTR 117: Queenita Fernandes on Smart Use of AI for Clinical Evaluation
A Quick Primer on FDA's Final Guidance for Cybersecurity in Medical Devices
LTR 116: Priyanka Murawala on ISO 10993 Update, Biocompatibility, Learning from Recalls
LTR 115: Startup Lessons from EU MedTech Shark Tank
LTR 114: What QA/RA Professionals Need to Know About Rapidly Growing MedTech in India
Case Study: When Underestimating Risk Leads to a Warning Letter
LTR 113: Highlights from the International Medical Device Safety Risk Management Conference
LTR 112: Overcoming organizational barriers to risk management through collaboration
LTR 111: How to sustain and grow a community of practice in risk management
Case Study: A Warning Letter Exposes Issues in Risk Analysis
Loading reviews...
Loading similar podcasts...