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PubMed

Patient Preference Information (PPI) in Medical Device Development: A Cross-Industry Review of Use-Cases.

PMID: 42323480 ·

Jonah Golder, Vanessa DeBruin, Alissa Hanna, Ellen Janssen, Korinne Jew, Barry Liden, Amy Pavlock, Dan Stephens, Liliana Rincon-Gonzalez

JournalTherapeutic innovation & regulatory science
Year
PMID42323480

Abstract

Patient Preference Information (PPI) is increasingly applied across the medical device lifecycle to inform product design, clinical trial planning, regulatory submissions, labeling, and shared decision-making. However, cross-company learnings remain fragmented. This review synthesizes five recent industry case studies illustrating diverse applications of PPI: Edwards Lifesciences (transcatheter tricuspid valve replacement), CVRx (Barostim neuromodulation therapy for heart failure), Medtronic (re

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