On April 21, 2021, 3D Dartmouth Device Development Symposium and MDIC co-sponsored the 3D EFS MDIC Symposium. The interactive virtual meeting focused on the Early Feasibility Studies (EFS) Initiative to facilitate first clinical use studies in the United States (U.S.). More than 250 people including representatives of device companies, clinical investigators, regulatory professionals, and investors attended the meeting.

 

The main symposium content consisted of three roundtable conversations intermixed with four interviews. The roundtable conversations covered:

• What Makes EFS Different - Key Issues & Stumbling Blocks: Indemnification, Reimbursement, Patient Recruitment

• Expanding EFS beyond Structural Heart - Learnings for other Disciplines

• Implications of the European Union Medical Device Directive (EU MDD) to the Medical Device Regulation (MDR) Transition on EFS

 

The interviews focused on the perspectives of a clinical site, a large company, an investigator, and the FDA.

​

Learn More

Read Key Insights from the Symposium

View the 3D EFS MDIC Symposium

View the Presentations, Round Tables and Interviews

On April 21, 2021, 3D Dartmouth Device Development Symposium and MDIC co-sponsored the 3D EFS MDIC Symposium. The interactive virtual meeting focused on the Early Feasibility Studies (EFS) Initiative to facilitate first clinical use studies in the United States (U.S.). More than 250 people including representatives of device companies, clinical investigators, regulatory professionals, and investors attended the meeting.

 

The main symposium content consisted of three roundtable conversations intermixed with four interviews. The roundtable conversations covered:

• What Makes EFS Different - Key Issues & Stumbling Blocks: Indemnification, Reimbursement, Patient Recruitment

• Expanding EFS beyond Structural Heart - Learnings for other Disciplines

• Implications of the European Union Medical Device Directive (EU MDD) to the Medical Device Regulation (MDR) Transition on EFS

 

The interviews focused on the perspectives of a clinical site, a large company, an investigator, and the FDA.

​

Read Key Insights from the Symposium

View the 3D EFS MDIC Symposium

View the Presentations, Round Tables and Interviews

On April 21, 2021, 3D Dartmouth Device Development Symposium and MDIC co-sponsored the 3D EFS MDIC Symposium. The interactive virtual meeting focused on the Early Feasibility Studies (EFS) Initiative to facilitate first clinical use studies in the United States (U.S.). More than 250 people including representatives of device companies, clinical investigators, regulatory professionals, and investors attended the meeting.

 

The main symposium content consisted of three roundtable conversations intermixed with four interviews. The roundtable conversations covered:

• What Makes EFS Different - Key Issues & Stumbling Blocks: Indemnification, Reimbursement, Patient Recruitment

• Expanding EFS beyond Structural Heart - Learnings for other Disciplines

• Implications of the European Union Medical Device Directive (EU MDD) to the Medical Device Regulation (MDR) Transition on EFS

 

The interviews focused on the perspectives of a clinical site, a large company, an investigator, and the FDA.

​

Read Key Insights from the Symposium

View the 3D EFS MDIC Symposium

View the Presentations, Round Tables and Interviews