The National Evaluation System for health Technology (NEST) is a voluntary data network of collaborators able to efficiently consolidate Real-World Evidence (RWE) from clinical registries, electronic health records, medical billing claims, patient-mediated data, and other sources to inform medical device development and evaluation, and to support regulatory decision-making throughout the total product lifecycle (TPLC).
The need for NEST was initially envisioned by a Planning Board convened by the Duke-Margolis Center for Health Policy in late 2015. In September 2016, the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) awarded a grant for the NEST Coordinating Center (NESTcc) to the Medical Device Innovation Consortium (MDIC), within which NESTcc operates today.
What is NEST Coordinating Center (NESTcc)?
The National Evaluation System for health Technology (NEST) Coordinating Center (NESTcc) provides the organizational framework to operationalize NEST. NESTcc was created to develop NEST and catalyze evidence generation in the medical device ecosystem.
NESTcc will catalyze the use of Real-World Data (RWD) and Real-World Evidence (RWE) for medical devices. Focused on identifying approaches for cost-effective and pragmatic evidence generation, NESTcc will be guided by these principles to support innovation and improve patient health outcomes.
The grant to operationalize NESTcc was awarded to the Medical Device Innovation Consortium (MDIC).
What is the Medical Device Innovation Consortium (MDIC)?
The Medical Device Innovation Consortium (MDIC) is the first-ever public-private partnership created with the sole objective of advancing approaches that promote patient access to innovative medical technologies. In September 2016, the U.S. Food and Drug Administration (FDA) awarded a grant to the 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.
What is Real-World Evidence (RWE), and why is it important?
Real-World Evidence (RWE) are insights gleaned from Real-World Data (RWD), or data generated in the routine course of care. This is different from evidence collected during pre-market research or clinical trials and takes into account real patient experiences. When collected and used effectively, RWE can benefit all members in the NEST ecosystem by informing and empowering patients, accelerating medical device innovation, and improving health care outcomes.
What is the NESTcc Governing Committee?
The NESTcc Governing Committee is comprised of members representing perspectives from across the medical device ecosystem, including those of patients, health providers, medical device manufacturers, regulators, and federal and private payers. This diverse set of perspectives includes leaders from both the private and public sectors. The Governing Committee provides a forum for multi-stakeholder input into NESTcc’s activities and the development of novel solutions for Real-World Evidence (RWE) adoption and dissemination. The NESTcc Governing Committee members collaborate to transform the ecosystem with patients and for the benefit of patients through enhanced collection and responsible use of RWE.
The Governing Committee is responsible for advising the NESTcc Executive Director on the development of the scope, strategy, and structure for the NESTcc, selecting demonstration projects for RWE collection and use, and developing a sustainability model with oversight from MDIC.
Will the information from NESTcc be used for regulatory decisions?
It is not yet determined how information from NESTcc might be used during the regulatory decision-making process. The information generated will deliver value to a broad group of stakeholders, including regulators, and how that information is used will be determined as NESTcc matures. Recently, the U.S. Food and Drug Administration (FDA) issued guidance for industry and FDA staff on the use of Real-World Evidence (RWE) to support regulatory decision-making for medical devices.