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

> **NIH FDA U01** · MEDICAL DEVICE INNOVATION CONSORTIUM · 2022 · $6,000,000

## Abstract

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.

## Key facts

- **NIH application ID:** 10383166
- **Project number:** 5U01FD006292-05
- **Recipient organization:** MEDICAL DEVICE INNOVATION CONSORTIUM
- **Principal Investigator:** Richard Smith
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2022
- **Award amount:** $6,000,000
- **Award type:** 5
- **Project period:** 2017-12-15 → 2026-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10383166

## Citation

> US National Institutes of Health, RePORTER application 10383166, NESTcc Renewal -Continuation of the National Evaluation System for Health Technology (NEST) Coordinating Center (CC) (5U01FD006292-05). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10383166. Licensed CC0.

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