In June 2019, NESTcc announced twelve new Real-World Evidence (RWE) Test-Cases that reflect the diversity of types of medical devices available and the different uses of data in pre-market and post-market settings, in addition to the eight initial Test-Cases announced in November 2018.
NESTcc Test-Cases will address two primary objectives. First, they will explore the feasibility for medical device ecosystem stakeholders to work 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).
Test-Case concepts were solicited from stakeholders across the ecosystem, including health systems, government organizations, non-profit patient organizations, and medical device manufacturers. The projects below will be executed through collaborations with Abbott Diagnostics, Adhesys Medical, AventaMed, Becton Dickinson (BD), Cook Medical, Intrinsic Therapeutics, Johnson & Johnson Medical Devices Companies, Medtronic, Pear Therapeutics, and W.L. Gore & Associates, Inc. as industry partners, as well as the American Sleep Apnea Association (ASAA), U.S. Food and Drug Administration (FDA), the Women’s Health Technology Coordinated Registry Network (WH-CRN), and Yale-New Haven Health Center for Outcomes Research and Evaluation (CORE).
In addition to these 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.
NESTcc’s twenty Test-Cases include projects along the 510(k) and premarket approval regulatory pathways, across nine disease areas, and throughout the medical device Total Product Life Cycle (TPLC).