MDIC Video Series: How to Maximize Patient Input in the Design and Development of Medical Device Clinical Trials

Jun 22, 2021Clinical, Discovery & Ideation, Patient Participation in Clinical Trials, Post-Market Monitoring, Regulatory Decision, SPI Guiding Principles

Patient Introduction

MDIC created a “How-To” video series to accompany its report on Maximizing Patient Input in the Design and Development of Medical Device Clinical Trials. The goal of this video series is to help medical device sponsors understand how to implement key recommendations from the report to maximize patient input in the design and development of medical device clinical trials.

Summary

The first video trains viewers on how to involve patients to improve trial enrollment and aspects of trial protocols and design. The second video provides a case study example of how one sponsor has implemented these steps. The last video presents and question-and-answer session with FDA-CDRH Patient Engagement leaders about how patient input can improve trials and generate information that can be used during regulatory discussions.

Speakers include:

  • Barry Liden, JD, Edwards Lifesciences
  • Michelle Tarver, MD, PhD, FDA
  • Owen Faris, PhD, FDA