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(1)
- 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