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).

Total Product Life Cycle
All
Pre-Market
Label Expansion
Post-Market
Surveillance
Coverage
Data Source
All
Claims
Electronic Health Records (EHR)
Registries
Patient-Generated Data (PGD)