This is the third in a series of reports from the Planning Board to support the U.S. Food and Drug Administration’s (FDA) work to establish the National Evaluation System for health Technology (NEST). NEST is envisioned as a cooperative network of partners working to use data, advanced methodologies, and good governance to improve the state of medical device evidence generation.
This report outlines recommendations on organizational governance such as operational leadership, bylaws, and the creation of a representative governing board for a Coordinating Center (Coordinating Center) charged with building NEST. The Planning Board has also included priority areas and activities for the strategic development of the Coordinating Center including data governance and recommendations for high-value demonstration project areas.
The Planning Board previously proposed that a Coordinating Center be established to develop NEST’s shared resources which should include: 1) building a voluntary network of data partners with re-usable data use and sharing agreements; 2) fostering a network of methodological expertise and a clearinghouse of best practices; and 3) establishing an effective multi-directional communication platform for stakeholders and the broader public.[i]
The Planning Board recommends the Coordinating Center use demonstration projects as a way to develop these shared resources while also showing the value of a nationally coordinated approach to bridging efforts and closing the gaps in medical device evaluation. The Planning Board recommended that these projects take place in two phases with aggressive timelines for initiation and completion; phase one projects should be feasibly completed within three years, and phase two projects should be completed within five years.
The recommended goals of phase one demonstration projects include:
The recommended goals of phase two demonstration projects include:
These projects should be used to show the value of the Coordinating Center, build the shared resources of NEST, as well as be an opportunity to test and refine the Center’s foundational priorities, process designs, and governance policies.
[i]Daniel, G., Colvin, H., Silcox, C., Bryan, J., McClellan, M., (Eds).(2016, April). Better Evidence on Medical Devices: A Coordinating Center for a 21st Century National Medical Device Evaluation System. Duke-Margolis Center for Health Policy, Washington DC. Retrieved from https://healthpolicy.duke.edu/sites/default/files/atoms/files/med-device-report-web.pdf
While this project is supported through a cooperative agreement with FDA, the views expressed in these papers are those of the Planning Board members, and do not necessarily reflect the official policies of the Department of Health and Human Services, nor does mention of specific projects or organizations imply endorsements by the U.S. Government or other organizations.