April 8, 2019

This document provides an updated Literature Review for the Medical Device Innovation Consortium (MDIC) Science of Patient Input (SPI) Working Group for submission as a deliverable under the MDIC BAA contract.  This high-level review reflects a broad scan of publicly available information about relevant organizations, initiatives, materials and publications.  While it is up to date as of March 2019, this summary is not exhaustive and should be viewed as a representative snapshot of activities and resources within the highly active and evolving field of patient engagement in clinical research. As new organizations, resources, and publications are being developed and launched continually, this work should be updated regularly to ensure its completeness and relevance over time.

MDIC received funding for this project from FDA BAA HHSF223201810116C “Framework for Patient Input in Medical Device Clinical Trials.”