The National Evaluation System for Health Technology Coordinating Center (NESTcc) has selected 11 demonstration projects for their potential to provide proof of concept for innovative and scalable approaches to real-world evidence generation across the medical device total product life cycle. This group of demonstration projects explores diverse aspects of evidence generation methods and data use that have the potential to demonstrate scalability across healthcare systems, device types, and manufacturers.

“Through the demonstration project designation, NESTcc is engaging with national experts and leaders in the real-world evidence field from industry, academia, and the FDA, and leveraging the lessons from their pioneering work to support NESTcc’s launch. Not only will these projects shed light on challenges and lessons learned in the design and execution of real-world evidence studies, but they will also identify gaps where NESTcc can help accelerate the use of medical device real-world evidence to support regulatory, coverage, patient, and clinical decision-making,” says Rachael L. Fleurence, PhD, executive director of NESTcc.

The projects, already underway at participating organizations and expected to be completed by the end of 2018, employ a range of health technologies—including traditional medical devices, imaging technologies, and in vitro diagnostics—across pre-market, label expansion, post-market, and surveillance use-cases.

Real-world data sources include different combinations of administrative claims, electronic health records, and patient- and device-generated data, that will be linked when necessary to provide data suitable for generating robust evidence.

Projects mainly focused on pre-market requirements:

  • Lung-RADS Assist: Artificial Intelligence Model Verification, Reporting, and Monitoring
  • Registry Assessment of Peripheral Interventional Devices—Superficial femoral and Popliteal Evidence Development as first device evaluation project
  • SAFE STEMI for Seniors: An International CRN-based Prospective Randomized IDE Study of Labelling for Diagnostic and Therapeutic Devices Used in Seniors Suffering Heart Attack

Projects mainly focused on post-market requirements (including post-approval studies)

  • Developing and Implementing Sustainable Real-World Evidence Infrastructure for in vitro Diagnostics Through Systemic Harmonization and Interoperability for Enhancement of Laboratory Data
  • Electrophysiology Predictable and Sustainable Implementation of National Registries
  • Feasibility Study to Evaluate the use of mHealth as Data Source in Post-Market Surveillance
  • Post-Market Medical Device Surveillance with a Novel mHealth Platform
  • Use of EHR-Based Data Network to Support Evidence Generation Across the Total Product Life Cycle
  • Use of linked implantable device/Medicare data to assess association between device diagnostics and patient outcomes