# Establishment of the National Evaluation System for health Technology Coordinating Center (NESTcc)

> **NIH FDA U01** · MEDICAL DEVICE INNOVATION CONSORTIUM · 2020 · $6,000,000

## Abstract

Project Summary/Abstract
The Medical Device Innovation Consortium (MDIC), a 501(c)3 Public-Private Partnership will continue its
work in bringing together device manufacturers, payers, regulatory agencies, patient groups, physicians,
providers and other relevant stakeholders to develop a National Evaluation System for health
Technology Coordinating Center (NESTcc). Our approach is to develop a CC that oversees the
development and operations of a collective modernized decentralized medical device evidence
generation system. We leverage and develop standards for data procurement, signal detection, data
processing, and reporting. The CC and governance system will be anchored on diverse stakeholder
inclusion, highest ethical standards, patient-centered outcomes, and a business culture of efficiency and
accountability to create the foundational principles of trust, transparency, scalability, sustainability and
accountability.
AIM 1: Launch the inaugural 15-member multi-stakeholder, patient-focused, expert, Governance
Committee to provide direction and support for the NESTcc. AIM 2: Continue to establish scope,
strategy (decentralization, stakeholder engagement, independence from bias, open science and data
sharing, objective prioritization), structure (primary data processes and secondary data and results
dissemination), standards (data, methods, reporting, and data access, audit and certification), in a
decentralized and federated NEST that will be built around a sustainable business model. AIM 3:
Manage NEST demonstration projects that develop, verify and operationalize methods of evidence
generation and data use, demonstrate scalability across healthcare systems and device types and
manufacturers, and prove out principles of NEST sustainability. AIM 4: Lead state-of-the-art methods
development work in critical areas for uses of patient-centered Real World Data and Real World
Evidence that are inclusive of the latest technological developments (mHealth etc.)
MDIC will continue to establish the NESTcc and create a sustainability plan for continued operations.
This will allow the use of real-world data in an efficient manner to accelerate patient access to safe and
effective devices quickly identify new safety problems for devices on the market and optimally and
appropriately rely on real-world evidence to support product approvals of public health importance, to
potentially shift premarket data collection to the postmarket setting, and to meet postmarket data
collection commitments through a modern system that leverage electronic health information
generated in the clinical and home setting.

## Key facts

- **NIH application ID:** 10161413
- **Project number:** 3U01FD006292-03S1
- **Recipient organization:** MEDICAL DEVICE INNOVATION CONSORTIUM
- **Principal Investigator:** Pamela Winer Goldberg
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2020
- **Award amount:** $6,000,000
- **Award type:** 3
- **Project period:** 2017-12-15 → 2021-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10161413

## Citation

> US National Institutes of Health, RePORTER application 10161413, Establishment of the National Evaluation System for health Technology Coordinating Center (NESTcc) (3U01FD006292-03S1). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10161413. Licensed CC0.

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