Call for Initial NEST Demonstration Projects Fall 2017
The next round of Demonstration Project submissions are due on November 1, 2017. Submissions will be accepted and reviewed on a rolling basis.
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 both in the pre- and post-market space.
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
The NEST Coordinating Center will begin identifying NESTcc Demonstration Projects in the Summer of 2017. These first NESTcc Demonstration Projects 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.
Identification of at least the first two NEST demonstration projects; Additional Projects will continue to be identified on a rolling monthly basis thereafter until November 2017. 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 over the coming months to begin establishing 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.
Proposed Timeline for Next Round of Submissions for NEST Demonstration Projects:
The proposed timeline is for third-round submissions. These applications will be reviewed on a rolling basis.
|November 1, 2017||
Deadline for receiving the application form for next round of demonstration projects.
Applications will be reviewed by a NESTcc review committee; Applicants may be asked to submit further information on their project per request.
To apply please download the application form here, complete, save, and send as an attachment to NESTcc@mdic.org. The next round of submissions are due by or before 11:59 pm ET on November 1, 2017. Submissions will be accepted and reviewed on a rolling basis.