Overview of Program:

MDIC and its partners are collaborating to improve our ability to include patient perspectives in the development, pre-market approval, and post-market evaluation of medical devices. The vision of the MDIC Science of Patient Input Steering Committee is to provide a venue for continued collaboration to advance the art and science of patient engagement in regulatory science, including advances in methodologies and tactical considerations for integrating the patient’s perspective and preferences in the design, clinical development and regulatory review of innovative medical technologies.

This project expands on the MDIC Patient Centered Benefit-Risk (PCBR) project, which was launched in 2013 with the vision “to establish a credible framework for assessing patient preferences regarding the probable benefits and risks of a proposed medical device and for incorporating patient preference information into pre-market and post-market regulatory submissions and decisions.” The Framework report “A Framework for Incorporating Information on Patient Preferences Regarding Benefit and Risk into Regulatory Assessments of New Medical Technology” was published in May 2015.