EFS Program & Site Demonstration Pilot
MDIC, in collaboration with our member working group (WG) participants, held its Kickoff Meeting for Early Feasibility Study (EFS): Administrative & Clinical Practices on March 6, 2017. This WG initially (A) assessed EFS efficiency through the collection and dissemination of an EFS Performance Metrics Baseline, and subsequently (B) initiated development of EFS Best Practices and Tools for both sponsors and sites. In 2018, MDIC continues partnering with sponsors and clinical sites to launch an EFS Site Demonstration Pilot. In this Demonstration Pilot, MDIC looks to serve as a conduit connecting EFS sponsors and sites towards the following goals:
- Provide EFS tools to study sponsors and sites
- Collect metrics on EFS tool implementation and impact
- Disseminate collected metrics and identified trends
- Update EFS tools and best practices to further facilitate U.S. patient “First-in-World” access to innovative medical technologies
MDIC working group outputs from our three EFS focus areas act in synergy, facilitating U.S. patient First-in-World access to novel medical technologies. If you are a medical technology ecosystem partner with experience conducting feasibility studies through the FDA/CDRH EFS Program, we invite you to contribute to this effort by completing our EFS Short Survey (click on link).