A Planning Board convened by the Duke-Margolis Center for Health Policy in late 2015 envisioned NEST as a voluntary network of data partners able to efficiently consolidate RWE to inform medical device evaluation and support regulatory decision-making throughout the total product life cycle (TPLC).
In September 2016, FDA awarded a grant for the NEST Coordinating Center (NESTcc) to the Medical Device Innovation Consortium (MDIC). MDIC is a 501(c)(3) public-private partnership with the objective of advancing approaches that promote patient access to innovative medical technologies. 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.
NESTcc named Rachael L. Fleurence, PhD as its Executive Director in April 2017 and established its inaugural Governing Committee, comprised of stakeholders across the medical device ecosystem, just three months later. By the end of 2017, NESTcc finalized and began execution of its Strategic and Operational plan, a five-year approach to building a fully operational and sustainable Coordinating Center.