Overview

Mission

NESTcc’s mission is to catalyze the timely, reliable, and cost-effective development of 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 real-world evidence (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.

About Us - The NEST Ecosystem

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.