Deep Dive: When Patient Preference Becomes Regulatory Evidence

Podcast: Let's Talk Risk! Podcast · Where MedTech professionals gain clarity and confidence to navigate complex decisions.

Opublikowano: 2026-08-28

Patient preference is no longer a soft qualitative afterthought. What if a device carries significant risks, but patients are willing to accept them for a meaningful clinical benefit? This Deep Dive examines how FDA’s evolving approach to Patient Preference Information (PPI) can turn those tradeoffs into quantitative evidence for regulatory benefit-risk decisions. Key highlights covered in the audio: * PPI is not the same as a patient-reported outcome. PROs describe what patients experience. PPI asks what risks patients are willing to accept to obtain a particular benefit. * Risk tolerance ca...