Case Study
Let's Talk Risk! Podcast
Case Study: How Patient Preference Data Rescued a High-Risk Device
- Published
- April 10, 2026
- Duration
- 20:37
- Summary source
- description
- Last updated
- Apr 29, 2026
Discusses Imagine you are running a pivotal clinical trial for a novel implant. The data comes back, and it is…
Summary
Imagine 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 …
Show notes
Imagine 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