NESTcc issues request for partners in generating real-world data to support improved evidence for medical devices

The National Evaluation System for health Technology Coordinating Center is inviting new partners to catalyse and enhance real-world data and evidence generation for medical devices through the Request for Information 23-001 entitled ‘Medical Device Real-World Evidence Marketplace’.

On 8th June 2023, the National Evaluation System for health Technology Coordinating Center (NESTcc) issued a Request for Information (RIF) 23-001 inviting interest from organizations to partner in generating high-quality solutions and expertise in research with real-world data (RWD) to support improved real-world evidence (RWE) for medical devices. The RIF defines five strategic areas NESTcc has identified for partnership to realize its vision of the NESTcc Medical Device RWE Marketplace, an ecosystem in which the right data sources can readily be paired with best-in-class research techniques and platforms. Organizations wishing to participate should submit their requests to NESTcc by 30th June 2023.

NEST was established in 2016 through a cooperative agreement between the Food and Drug Administration (FDA) and the Medical Device Innovation Consortium (MDIC) as the first public-private partnership created with the sole objective of advancing regulatory science of medical devices for patient benefit. The purpose of NEST is to increase quality and efficiency in the generation of RWE to inform medical device development and evaluation, as well as support clinical, patient, regulatory and reimbursement decisions throughout the total product lifecycle. Funding of NESTcc by the FDA comes through user fees generated via Medical Device User Fee Amendment (MDUFA) V and contributes towards the FDA’s commitment to advancing RWE.

NESTcc’s work to-date with its initial Research Network on RWE test-cases and sponsored research projects has demonstrated gaps in its infrastructure and capabilities. NESTcc is now seeking additional strategic partners to enhance and build on the strengths of its existing Research Network to create and host a marketplace of organizations engaging in various aspects of RWE. The goal of the marketplace is to provide the broadest range of solutions for all stakeholders: NESTcc will understand the strengths of each organization and partner across organizations to garner the best fit solution for each RWE study.

NESTcc requires the effort of the community of stakeholders, strategic partnerships and solution providers to exemplify fit-for-purpose RWE today and to envision best practice RWE generation in the future.

NESTcc has identified five strategic areas for partnership to realize its vision of the NESTcc RWE Marketplace:

1. Data platforms: providing a foundation for data gathering and curation, especially platforms that put the patient in the driver’s seat, to gather health data into one place and share with the device community
2. Data sources: creating a national resource mirroring the experience of patient care in the United States and general experience of health throughout an individual’s life
3. Data connectors: deliver continuity of care and experience between data sources (e.g., via aggregation/linkage) while maintaining patient privacy and protections
4. Data science and research methodology: design and analysis expertise and experience necessary to obtain the epidemiological, informatic and statistical rigor inherent in fit-for-purpose RWD analysis
5. Analytic cores: conducting analyses of ingested data or packaging analytics for data sources to conduct analyses, ensuring rapid, valid and verified analysis suitable for RWD research

Organizations selected to join the marketplace will have, in addition to payment for their work, the opportunity to showcase their skillsets, contribute their expertise to RWD studies, and participate in collaborations which set the standard for best practice RWE generation going forward.

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