NESTcc Renewal -Continuation of the National Evaluation System for Health Technology (NEST) Coordinating Center (CC)

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PROJECT SUMMARY/ABSTRACT The Medical Device Innovation Consortium (MDIC) is applying to continue its role as the National Evaluation System for health Technology Coordinating Center (NESTcc). NESTcc is a cooperative network that consists of a coordinating center (MDIC), the U.S. Food and Drug Administration (FDA/CDRH), Network Collaborators, and a Governing Committee that represents the FDA, industry and their relevant trade associations, clinicians/clinician groups, academic health systems and research organizations, digital health and technology companies, payors, and patients/patient advocacy groups. The objectives of NESTcc are to: (1) Support implementation of NEST through sustainable multi-stakeholder partnerships; (2) Develop new systems of data collection/analysis to permit prospective active medical device postmarket risk identification; (3) Support the development of and access to high quality data sources that can be used in comprehensive evaluation of medical device performance and associated outcomes by multiple stakeholders; (4) Develop methodological approaches/systems that facilitates the use of real-world evidence for regulatory decision-making, and for uses by other stakeholders, throughout the entire device lifecycle. As NESTcc, MDIC will continue to provide robust scientific oversight and proven support for the next cycle of this grant, with key responsibilities for leadership in real-world evidence (RWE) research for the Research Network, operational and project management of research studies and projects, medical device safety (MDS) for active surveillance, Collaborative Community (CC); development and deployment of innovative infrastructure and tools; novel approaches for study design and statistical methodologies; and management and distribution of NEST funds. NESTcc will manage relationships among its partners to facilitate the use of RWD in understanding medical devices in a way that is meaningful for the stakeholder communities. NESTcc will monitor, promote, and facilitate infrastructure development for use of RWE for medical device evaluation, not just for regulatory decision-making but for the wider community of stakeholders. NESTcc will optimize the cost of, access to, quality of, and sharing of data related to medical device evaluation; promote the adoption of best practices using RWE; develop a transparent and streamlined process for evaluating and disseminating medical device safety and effectiveness information; and develop a sustainable business model. Our proposed approach represents a strong, experienced leadership team to ensure efficient scientific and administrative support to NEST using advanced and innovative technologies. A multiple PI leadership plan is proposed shared by Pamela Goldberg (MDIC CEO) and Flora Sandra Siami (MDIC SVP and head of NESTcc), with clearly delineated roles and responsibilities for leading and directing NESTcc.