The 21st Century Cures Act and Early Feasibility Studies for Cardiovascular Devices: What Have We Learned, Where Do...

Area of Science:

• Medical device development
• Clinical trial management
• Regulatory science

Background:

• Early feasibility studies (EFS) are crucial for evaluating novel medical devices in the U.S.
• The 21st Century Cures Act emphasizes the importance of these studies.
• Despite regulatory improvements, clinical site-level barriers hinder EFS performance.

Purpose of the Study:

• To review existing impediments in U.S. early feasibility studies.
• To propose a clinical site consortium to address these challenges.
• To improve the overall U.S. clinical trial ecosystem for medical devices.

Main Methods:

• Review of current challenges in early feasibility studies.
• Description of a proposed clinical site consortium structure and function.
• Analysis of the U.S. clinical trial landscape.

Main Results:

• Identified significant hospital and clinical site-level impediments to EFS.
• Outlined a model for a clinical site consortium.
• Highlighted the need for systemic improvements in the U.S. clinical trial ecosystem.

Conclusions:

• Addressing site-level barriers is essential for successful early feasibility studies.
• A clinical site consortium can streamline the evaluation of new medical technologies.
• Improving the EFS process facilitates patient access to innovative medical devices.