Let's Talk Risk! Podcast

Autor: Where MedTech professionals gain clarity and confidence to navigate complex decisions.

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

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1. LTR 166: Building a MedTech Career in the Age of AI – Let's Talk Risk! Podcast
2. Executive Brief: PCCPs as a Competitive Strategy – Let's Talk Risk! Podcast
3. LTR 165: Managing Characteristics Related to Safety – Let's Talk Risk! Podcast
4. Executive Brief: What FDA is Looking For in Your Tox Data to Ensure Safety – Let's Talk Risk! Podcast
5. LTR 164: Susan Neadle on Combination Device Risk Management – Let's Talk Risk! Podcast
6. Deep Dive: When the Risk Baseline and the QMS Both Break Down – Let's Talk Risk! Podcast
7. Deep Dive: When FDA Qualifies the Ruler – Let's Talk Risk! Podcast
8. Deep Dive: What FDA’s QMSR Warning Letters Are Revealing – Let's Talk Risk! Podcast
9. Deep Dive: The PFAS Substitution Risk Paradox in Medical Devices – Let's Talk Risk! Podcast
10. Deep Dive: When Patient Preference Becomes Regulatory Evidence – Let's Talk Risk! Podcast
11. Deep Dive: Designing Safety Into Autonomous Robotic Devices – Let's Talk Risk! Podcast
12. LTR 163: FDA’s New Risk Lens Under QMSR – Let's Talk Risk! Podcast
13. Deep Dive: First FDA Warning Letter Under QMSR – Let's Talk Risk! Podcast
14. LTR 162: Using HHE for Risk-Based Decisions – Let's Talk Risk! Podcast
15. Deep Dive: FDA's RWE Guidance – Let's Talk Risk! Podcast
16. LTR 161: AI Governance by Design – Let's Talk Risk! Podcast
17. Case Study: Why FDA Cybersecurity Expectations Are Really QMS Expectations – Let's Talk Risk! Podcast
18. LTR 160: IMSC26 Highlights - From Compliance to Proactive MedTech Safety – Let's Talk Risk! Podcast
19. LTR 159: The Evolving Regulatory Landscape for AI in MedTech – Let's Talk Risk! Podcast
20. Case Study: FDA’s New Expectation for Use-Related Risk in Medical Device Submissions – Let's Talk Risk! Podcast
21. LTR 158: Three Questions To Keep Risk Connected to Decisions – Let's Talk Risk! Podcast
22. LTR 157: Why Risk Doesn't Get Heard and How to Change That – Let's Talk Risk! Podcast
23. LTR 156: Using AI as a Thinking Partner in Product Development Without Losing Control – Let's Talk Risk! Podcast
24. LTR 155: Leverage VIP to Move from Compliance to Capability – Let's Talk Risk! Podcast
25. LTR 154: From Procedures to Judgment - Leading Through QMSR Inspections – Let's Talk Risk! Podcast
26. LTR 153: Sherita Black on Building a Practical Policy for Risk Acceptability – Let's Talk Risk! Podcast
27. LTR 152: Omar Al Kalaa on Telesurgery and the Future of Remotely Controlled Medical Systems – Let's Talk Risk! Podcast
28. LTR 151: Sarai Pahla on Managing Supply Chain Disruption Risk in Life Sciences – Let's Talk Risk! Podcast
29. Case Study: How Patient Preference Data Rescued a High-Risk Device – Let's Talk Risk! Podcast
30. LTR 150: Jonathan Kendler on Rethinking Human Factors Engineering for AI/ML-Enabled Devices – Let's Talk Risk! Podcast