MDIC Early Feasibility Study Symposium

Virtual Conference
April 21, 2021

MDIC Early Feasibility Study Symposium

The Medical Device Innovation Consortium (MDIC) 3D-EFS Symposium is a 3.5-hour interactive virtual meeting focused on the Early Feasibility Study (EFS) Initiative to facilitate the first clinical use studies in the United States, providing updates and examining the current roadblocks. The Symposium is co-sponsored by MDIC and The Dartmouth Device Development (3D) Symposium Office.

An early feasibility study (EFS) is a limited clinical investigation of a device early in development. The EFS Program at the Center for Devices and Radiological Health (CDRH), part of the Food and Drug Administration (FDA), facilitates the conduct of early feasibility studies in the United States to increase access for patients to potentially beneficial technologies and to support device innovation.

The Symposium is intended for people working on the development and/or evaluation of early medical device development including industry (Large Strategic and Start-up companies), clinical investigators, regulatory professionals, and investors.

Symposium Outline:

- EFS – Key Issues, Stumbling Blocks, Reimbursement, Contract Negotiation, Indemnification

- Structured interviews with EFS experts from: industry (large market leaders and start-ups), clinical sites, clinical investigators

- Expanding EFS Cardiovascular experience to other disciplines

- EFS compared with EU MDD-transition – perspectives from thought leaders

Key Speakers:

- Jeffrey E. Shuren, MD, JD | Director of the Center for Devices and Radiological Health at the Food and Drug Administration (FDA)

- David R. Holmes, Jr., MD, MACC| Mayo Clinic

- Andrew Farb, MD | Chief Medical Officer, Division for Cardiovascular Devices, CDRH

- Aaron V. Kaplan, MD, FACC | Founder & Chief Medical Officer, Dartmouth Device Development Symposia