The NEST community is passionately committed to transforming the way medical device technologies are tested, approved and monitored.
We envision a world in which people are empowered to make informed medical choices that enable patients to live their lives to the fullest extent possible.
NESTcc serves a dual role in the medical device ecosystem:
As a coordinating center offering services to organizations seeking to sponsor medical device/technology research based on high-quality real-world data (RWD).
As a collaborative community comprised of representatives from across the medical device ecosystem, including FDA, working together to coalesce teams of diverse stakeholders around common needs and initiatives.
Leveraging our unique position, we combine real-world evidence with unparalleled expertise to accelerate patients’ access to safe and effective medical technology.
Daniel Caños, PhD, MPH, Director, Office of Clinical Evidence and Analysis, OPEQ, CDRH, FDA, discusses the aim of NEST and the role of NESTcc in advancing real-world evidence.
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.
In 2017, NESTcc established its inaugural Governing Committee, comprised of stakeholders across the medical device ecosystem. In the years since, NESTcc has led a number of initiatives to advance the innovative use of Real-World Evidence.
Read more about NESTcc’s Demonstration Projects.
Read more about the Network Collaborators in the NESTcc Research Network.
Read more about the NESTcc Test-Cases.
Read more about NESTcc’s Test-Cases.
Read more about the Frameworks.
Read more about the launch.
Read more about the Network Collaborator.
Read more about the UDI Initiative.