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(6)
- StandardSummaries onlyLTR 159: The Evolving Regulatory Landscape for AI in MedTech
Published Jun 26, 2026
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 with Priya Setty and Atty Chakraborty for a wide-ranging discussion on how AI is changing medical device
- 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 127: Ajay Dankar on Proactive AI Governance in MedTech
Published Oct 10, 2025
Summary“Ethical and compliant AI adoption isn’t a barrier to innovation. It makes your business stronger and more resilient.”In this Let’s Talk Risk! conversation, host Naveen Agarwal reconnects with longtime friend and Silicon Valley tech leader Ajay Dankar, Co-Founder of Trussed AI. Ajay shares insights from his career at Google, AWS, Adobe, and PayPal, and explains how generative and agentic AI are reshaping industries from healthcare to finance.Together, they explore the promise and uncertai
- StandardSummaries onlyLTR 125: Kevin Schawinski on Building Trustworthy AI and MedTech Readiness
Published Sep 26, 2025
Summary“EU MDR is the spiritual ancestor of the EU AI Act”.In this Let’s Talk Risk! conversation, host Naveen Agarwal welcomes Kevin Schawinski, astrophysicist turned AI entrepreneur and CEO of Modulos AG. Kevin shares his journey from studying black holes to building AI governance solutions, and explains how the EU AI Act is modeled after the EU Medical Device Regulation (MDR). He highlights the parallels between product safety regimes in MedTech and emerging AI regulation, offering practical i
- 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