NESTcc has selected 8 initial Real-World Evidence (RWE) Test-Cases. These Test-Cases were submitted in January 2018 through a public call and will address two primary objectives. First, they will explore the feasibility for the medical device industry to work with Real-World Data (RWD) sources and NESTcc’s initial set of Network Collaborators. Second, the Test-Cases will help identify areas where NESTcc could play a role in reducing transaction costs (e.g., contracting, IRB, data sharing agreements, publication policies).
The projects below will be executed through collaborations with Abbott, Adhesys Medical, Johnson & Johnson Medical Devices Companies, and W.L. Gore & Associates, Inc. as industry partners. In addition to the industry groups working through independent collaborations, the American Academy of Orthopaedic Surgeons (AAOS) is serving as a neutral convener, bringing together DJO Global, DePuy Synthes, Smith & Nephew, Stryker, and Zimmer Biomet for a Test-Case that will bring together NESTcc Network Collaborators with the American Joint Replacement Registry (AJRR) which is housed at AAOS.
The first round of Test-Cases includes projects along the 510(k) and premarket approval regulatory pathways, across five disease areas, and throughout the medical device total product lifecycle.
The second round of Test-Cases is scheduled to be awarded in February 2019. The second round of Test-Cases included two calls for concepts that were posted in July 2018: a broad announcement and a targeted announcement seeking concepts to utilize patient-generated health data (PGD). Both announcements were open to concepts from stakeholders across the ecosystem, including health systems, government organizations, non-profit patient organizations, and medical device manufacturers.