Real-World Evidence to Assess Medical Devices: Advances through the National Evaluation System for health Technology (NEST)

Background: The Food and Drug Administration funded the Medical Device Innovation Consortium to create the National Evaluation System for health Technology (NEST). The mission of the NEST Coordinating Center (NESTcc) is to accelerate the development and translation of new and safe health technologies, leveraging Real-World Evidence (RWE) and innovative research. NEST has created a Data Network with over 13 Data Partners.

Objectives: To provide an overview of the NEST initiative, the NESTcc’s role in facilitating the timely, reliable and cost-effective development of high-quality RWE, the NESTcc test cases and demonstration projects, and their values from the perspectives of regulators, health systems, and industry. Anyone who is interested in learning the latest regulatory initiative in RWE innovation would benefit by attending.
Description: This 90-minute symposium will bring together leaders representing key stakeholders across the medical device ecosystem involved in NESTcc programs. 
Moderators:
Shumin Zhang, MD, ScD, Director Regulatory RWE & Epidemiology at Johnson & Johnson
Panelist presentations (12 minutes each):
• Daniel Caños, PhD will discuss considerations for the use of RWE for regulatory decisions for medical devices and how NEST supplements this. Dr Caños is Acting Director, Office of Clinical Evidence and Analysis at the FDA Center for Devices and Radiologic Health
• Robbert Zusterzeel, MD, PhD, will describe the network of research collaborators created by NESTcc, the test cases selected for funding by NESTcc, and the process for allocating funds for research. Dr Zusterzeel is a Director at the NEST Coordinating Center.
• Joseph Drozda, MD, will describe the experience of a healthcare system in implementing NESTcc test cases using their electronic medical record and supply chain databases and lessons learned about data quality and suitability to address research questions.  Dr Drozda is the Director of Outcomes Research at Mercy Health, St Louis, Missouri.
• Danica Marinac-Dabic, MD, PhD, FISPE, will present how the MDEpiNet, which is a public-private partnership of coordinated registry networks led by the FDA, is coordinating with the NEST initiative for using registry data.  Dr Marinac-Dabic is Associate Director, Office of Clinical Evidence and Analysis, at the FDA Center for Devices and Radiologic Health
• Paul Coplan, ScD, MBA, FISPE, will present examples of how the NEST test cases are being used to enhance safety surveillance of medical devices and assess whether comparative safety and effectiveness studies using electronic medical record data can be used  for label extensions of medical devices.  Dr Coplan is VP and head of Medical Device Epidemiology & Real World Data Sciences at Johnson & Johnson.