The National Evaluation System for health Technology Coordinating Center (NESTcc) seeks to support the sustainable generation and use of timely, reliable, and cost-effective Real-World Evidence (RWE) throughout the medical device lifecycle, using high-quality Real-World Data (RWD) and methodological guidelines developed by NESTcc’s Data Quality and Methods Subcommittees.

The current fragmented health care ecosystem does not support the seamless, near real-time, cost-effective use of health data to generate high-quality evidence needed for regulatory decision-making in both the pre- and post-market medical device spaces.

Stakeholders across the medical device ecosystem stand to benefit from improved use of RWE and RWD generated in the course of clinical care and everyday life by patients, providers, or payers. Opportunities include increased patient awareness of device safety issues, low-cost efficient evidence generation for regulatory review, and improved patient and provider ability to make care decisions based on robust data.

Read the full, open-access article on the role of NESTcc in advancing RWE for medical devices.

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

  • December 2017

    NESTcc develops Strategic & Operational Plan

    Read more about NESTcc’s Strategic & Operational Plan.

  • February 2018

    NESTcc announces full portfolio of Demonstration Projects

    Read more about NESTcc’s Demonstration Projects.

  • March 2018

    NESTcc launches assessment of appropriate uses of RWE for medical devices

  • April 2018

    NESTcc establishes Data Network

    Read more about the Network Collaborators in the NESTcc Data 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.