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
Filtered episodes(7)
- StandardSummaries onlyCase Study: FDA’s New Expectation for Use-Related Risk in Medical Device Submissions
Published Jun 19, 2026
Case StudyYou 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 Category 3 human factors validation may become the default concern when critical tasks are introduced or
- 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 onlyCase Study: The WATCHMAN TruSeal Recall and the Hidden Risk of Procedural Variation
Published Oct 20, 2025
Case StudyIn 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: Commercial success amplified rare risks as adoption expanded to community hospitals.* Narrative analytics: Tex
- StandardSummaries onlyCase Study: Comparing EU and FDA Cybersecurity Guidance for Medical Devices
Published Sep 22, 2025
Case StudyIn 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 medical devices and why cybersecurity is now inseparable from patient safety.* Where the EU and FDA gui
- StandardSummaries onlyCase Study: What AI/ML Device Recalls Reveal About Emerging Risks
Published Sep 8, 2025
Case StudyNote: 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 highlights* The Landscape: 1,247 FDA cleared AI/ML devices across 155 product codes; 38 recall events i
- StandardSummaries onlyCase Study: Contrasting U.S. and EU Approaches to AI Regulation
Published Aug 25, 2025
Case StudyIn 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 security imperative.* FDA Guidance: Good Machine Learning Practices, predetermined change control plans
- StandardSummaries onlyCase Study: When Clues to a Future Recall Hide in Plain Sight
Published Aug 11, 2025
Case StudyIn 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 early warning signals going back five years. Through deep narrative review, we uncover overlooked patte