PLAY PODCASTS
Let's Talk Risk! with Dr. Naveen Agarwal

Let's Talk Risk! with Dr. Naveen Agarwal

Where MedTech professionals gain clarity and confidence to navigate complex risk, quality, and leadership challenges.

Casual and informal conversations about practical aspects of medical device risk management. · Where MedTech professionals gain clarity and confidence to navigate complex decisions.

185 episodesEN

Show overview

Let's Talk Risk! with Dr. Naveen Agarwal has been publishing since 2023, and across the 3 years since has built a catalogue of 185 episodes. That works out to roughly 85 hours of audio in total. Releases follow a weekly cadence.

Episodes typically run twenty to thirty-five minutes — most land between 26 min and 34 min — and the run-time is fairly consistent across the catalogue. None of the episodes are flagged explicit by the publisher. It is catalogued as a EN-language Technology show.

The show is actively publishing — the most recent episode landed 1 weeks ago, with 38 episodes already out so far this year. The busiest year was 2025, with 70 episodes published. Published by Where MedTech professionals gain clarity and confidence to navigate complex decisions..

Episodes
185
Running
2023–2026 · 3y
Median length
30 min
Cadence
Weekly

From the publisher

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

Latest Episodes

View all 185 episodes

LTR 164: Susan Neadle on Combination Device Risk Management

Oct 2, 202626 min

Deep Dive: When the Risk Baseline and the QMS Both Break Down

Sep 25, 202621 min

Deep Dive: When FDA Qualifies the Ruler

Sep 18, 202619 min

Deep Dive: What FDA’s QMSR Warning Letters Are Revealing

Sep 11, 202621 min

Deep Dive: The PFAS Substitution Risk Paradox in Medical Devices

Sep 4, 202620 min

Deep Dive: When Patient Preference Becomes Regulatory Evidence

Aug 28, 202632 min

Deep Dive: Designing Safety Into Autonomous Robotic Devices

Aug 21, 202620 min

LTR 163: FDA’s New Risk Lens Under QMSR

Aug 14, 202627 min

Deep Dive: First FDA Warning Letter Under QMSR

Aug 7, 202620 min

LTR 162: Using HHE for Risk-Based Decisions

Jul 31, 202627 min

Deep Dive: FDA's RWE Guidance

Jul 24, 202620 min

LTR 161: AI Governance by Design

Jul 17, 202625 min

Case Study: Why FDA Cybersecurity Expectations Are Really QMS Expectations

Jul 10, 202617 min

LTR 160: IMSC26 Highlights - From Compliance to Proactive MedTech Safety

Jul 3, 202647 min

LTR 159: The Evolving Regulatory Landscape for AI in MedTech

Jun 26, 202642 min

Case Study: FDA’s New Expectation for Use-Related Risk in Medical Device Submissions

Jun 19, 202641 min

LTR 158: Three Questions To Keep Risk Connected to Decisions

Jun 12, 202628 min

LTR 157: Why Risk Doesn't Get Heard and How to Change That

May 29, 202627 min

LTR 156: Using AI as a Thinking Partner in Product Development Without Losing Control

May 22, 202627 min

LTR 155: Leverage VIP to Move from Compliance to Capability

May 15, 202626 min
Naveen Agarwal, Ph.D.