RFI: Data and Analytics Solutions for NEST
Request for Information: Data and Analytics Solutions for Medical Device Evidence Generation
Submissions Due September 1, 2017
Over the past decade, two societal trends have affected the way we think about clinical data for medical technology, and have driven the need for an organized strategy to collect and analyze data in near real-time to optimize patient health outcomes. First, the notion that we can predict the performance and clinical outcomes of medical technologies in common clinical settings via inference derived from a historical pivotal clinical trial, or set of pivotal clinical trials, has been challenged. Second, is the extensive and widespread digitization of medical information in clinical practice, although there are still significant challenges in converting clinical practice digital data into useable evidence for regulatory decision-making.
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 and reliable development of real world evidence associated with medical devices for pre- and post-market needs. NESTcc has the potential to support a pre- post-market paradigm shift with the balance shifting to virtual registries of secondary use data enabling a real-world evidence base healthcare learning system. For more information regarding NESTcc please visit About NESTcc.
While still early in its planning and development, NEST is being conceived as a decentralized and federated structure. One model for improved evidence generation for medical devices includes establishing collaborations with a range of third party collaborators from the academic, non-profit and private sectors who will compete for business. Under this model the NESTcc would focus on developing: (1) standards and processes for data, (2) certification that data warehouses and data integrators are conforming to data model standards and using appropriate methods, (3) audit to establish that device manufacturers in the evidence generation system are using certified data systems and can reproduce any analysis, and (4) access to the data and reports for FDA and third parties. By maintaining a modular system, NEST will be more flexible and can evolve, eliminating the need to overhaul entire systems to reach efficiency.
We are looking to the wider ecosystem to provide possible solutions that employ state-of-the-art data and computer science technologies and data flow infrastructure that will deliver low cost, high-quality, longitudinal medical device information in near real-time. The reliance on data use agreements (DUAs), data licensing, data standards and data processes to enable data flow models from decentralized data warehouses has the potential to create a responsive ecosystem of innovative data integration and data warehousing services.
Request for Information (RFI)
NESTcc is seeking to identify companies, organizations, collaborations and strategically coordinated registries from the private and non-profit sector that can offer third-party solutions to the problems described above. These solutions must develop, verify and operationalize methods of evidence generation and data use that are of high quality, cost-effective, and in near real-time, as well as contribute to informing NESTcc as it builds out its critical functions and processes for sustainability. We are interested in identifying a range of collaborators from the academic, non-profit and private sectors with access to high quality data 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 the medical device industry, the FDA and other key stakeholders in the ecosystem.
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 include or likely include:
- An initial call for Demonstration Projects, which 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.
- A separate call for targeted Demonstration Projectsin 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.
RFI Posted: July 14, 2017
Response Due: September 1, 2017