Events

Wednesday, April 21, 2021 | 12:00 – 3:30pm ET

3D-EFS MDIC 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 intended for people working on new technology and/or the 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-MDR transition – perspectives from thought leaders

Key Speakers:

• Jeffrey 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 | Director, 3D Dartmouth Device Development Symposia, Dartmouth-Hitchcock Medical Center & Geisel School of Medicine at Dartmouth
• Jaime Walkowiak, JD | Chief Operating Officer and Senior Vice President of Research, Baylor Scott & White Research Institute
• Pamela Goldberg, MBA | President and CEO, MDIC

Who Should Attend:

• Clinical research personnel in medical device companies and investigational sites
• Clinical investigators
• Regulatory affairs personnel
• Investors
• The Symposium is co-sponsored by MDIC and The 3D Dartmouth Device Development Symposium Office.