The current fragmented health care system lacks adequate infrastructure to enable high-quality, near real-time, and low-cost Real-World Evidence (RWE) generation for medical devices. The inability to access and integrate longitudinal datasets has slowed medical device innovation, delayed the detection of safety signals, and created regulatory inefficiencies, impacting stakeholders across the medical device ecosystem, including industry, regulators, payers, patients, clinicians, and health systems. Solving these challenges could improve patients’ timely access to safe medical devices and their quality of life.
To change the current ecosystem, the National Evaluation System for health Technology (NEST) was designed to serve as a catalyst in establishing functional and efficient pathways for key stakeholders to generate lower-cost, nearer real-time RWE of sufficient quality for regulatory, coverage, patient, and clinical decision-making.
In September 2016, FDA awarded a grant to the Medical Device Innovation Consortium (MDIC) to establish the National Evaluation System for health Technology Coordinating Center (NESTcc). The selection of a third-party entity was important given the need for NESTcc to establish relationships and agreements between partners in a neutral, objective manner, and to solicit a balanced representation from stakeholders.