NESTcc Demonstration Projects

Initial Demonstration Projects Address Key Use Cases for the NESTcc

The NESTcc has selected the first-round of Demonstration Projects that address several key use-cases to demonstrate the feasibility and value of generating Real-World Evidence for clinical studies across the Total Product Life Cycle. Details on the selected projects are available here.

Call for NESTcc Demonstration Projects Fall 2017

The current submission cycle for NESTcc Demonstration Projects is now closed. Please contact NESTcc@mdic.org with any questions, or click here to learn more about NESTcc’s selected Demonstration Projects.

Context

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

In 2016, the FDA awarded a grant to the Medical Device Innovation Consortium (MDIC) to establish the National Evaluation System for health Technology Coordinating Center (NESTcc). NESTcc’s mission is to serve as a catalyst within the ecosystem to support the timely, reliable and cost-effective development of real-world evidence associated with medical devices both for pre- and post-market requirements. While still early in its planning and development, NESTcc is being conceived as a decentralized and federated organization. By maintaining a modular system, NESTcc will be more flexible and can evolve, eliminating the need to overhaul entire systems to reach efficiency. For more information regarding NESTcc please visit About NESTcc.

NESTcc Demonstration Projects

NESTcc is in the process of selecting Demonstration Projects that will serve to develop, verify, and operationalize methods of evidence generation and data use, demonstrate scalability across healthcare systems and device types and manufacturers, and build out critical functions and processes for a sustainable NESTcc. To learn more about Projects selected to date, click here. Reviews are currently under way for second- and third-round submissions and will be announced this winter.

Moving forward, additional Projects will continue to be identified on a rolling monthly basis. This call for submissions is for an initial set of NESTcc Demonstration Projects and targets mature projects currently underway that have existing sources of funding for core activities.  Preference is for projects with multiple partners including one or several medical device industry stakeholders. NESTcc may provide limited financial support for activities related to sharing processes and results through meetings and other mechanisms.

This will be one of several activities undertaken by the NESTcc in the coming months to establish the critical partnerships needed to build NEST. Additional planned activities will likely include:

  • A separate call for targeted Demonstration Projects in areas that have been identified as mission-critical for the development of a sustainable, efficient medical device evidence generation evaluation system. Funding from the NESTcc may be available for these projects.
  • A Request for Information to identify third party collaborators from the academic, non-profit and private sectors with access to high quality data warehouses that can integrate such areas as cloud services, data aggregation, data storage, and data analytics to provide high quality, near real time and cost-effective solutions to the NESTcc to support the needs of medical device industry, the FDA and other key stakeholders in the ecosystem.

If you have any additional questions please contact NESTcc@mdic.org.