Overview

Mission

The mission of the National Evaluation System for health Technology Coordinating Center (NESTcc) is to catalyze the timely, reliable, and cost-effective development of real-world evidence (RWE) to enhance regulatory and clinical decision-making.

Vision

NESTcc’s vision is to be the leading organization within the health technology and medical device ecosystem for conducting efficient and timely high-quality RWE studies throughout the total product life cycle (TPLC).

Role

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.

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.

History

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.

  • September 2016

    FDA awards MDIC grant for NESTcc

  • July 2017

    NESTcc establishes Governing Committee

  • February 2018

    NESTcc announces full portfolio of Demonstration Projects

    Read more about NESTcc’s Demonstration Projects.

  • April 2018

    NESTcc establishes Research Network

    Read more about the Network Collaborators in the NESTcc Research Network.

  • November 2018

    NESTcc announces eight initial Test-Case research projects

    Read more about the NESTcc Test-Cases.

  • June 2019

    NESTcc announces 12 additional Test-Cases

    Read more about NESTcc’s Test-Cases.

  • December 2019

    NESTcc accepts proposals for development of active surveillance cloud infrastructure

  • February 2020

    NESTcc publishes Data Quality and Methods Frameworks

    Read more about the Frameworks.