National Evaluation System for health Technology Coordinating Center posts Request for Information (RFI) 23-001 for Medical Device Real-World Evidence Marketplace

By: Medical Device Innovation Consortium via Business Wire

June 08, 2023 at 18:12 PM EDT

The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), is soliciting the interest of organizations to partner in generating high-quality solutions and expertise with real-world data (RWD) to support improved evidence for medical devices. Expertise is sought in five strategic areas to realize the vision of the NESTcc real-world evidence (RWE) Marketplace for the medical device ecosystem:

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

Given the complexity of working with RWD and transforming it into RWE, it is understood that many entities involved with RWD/RWE may provide services and technologies that do not fit neatly into these five areas. NESTcc is interested in learning of any relevant service or technology which may improve the ability of RWE generation.

The RFI can be found here.

To submit your response, click here.

This opportunity closes at 5:00 p.m. ET on June 30, 2023.

About the National Evaluation System for health Technology Coordinating Center

In 2016, the U.S. Food and Drug Administration (FDA) awarded the Medical Device Innovation Consortium (MDIC) funding to establish the National Evaluation System for health Technology Coordinating Center (NESTcc). NESTcc is advancing the use of real-world evidence (RWE) in medical devices for regulatory decision-making and committed to transforming the way medical device technologies are tested, approved, and monitored. The Coordinating Center combines RWE system infrastructure with the unparalleled expertise of its network collaborators to accelerate patients’ access to safe and effective medical technology and provide Quality Evidence by Design™. For more information, visit http://www.nestcc.org.

About the Medical Device Innovation Consortium

Founded in 2012, the Medical Device Innovation Consortium (MDIC) is the first public-private partnership created with the sole objective of advancing medical device regulatory science throughout the total product life cycle. MDIC’s mission is to break down barriers in the medical technology life cycle to accelerate innovation and adoption of safe, effective, and high-quality medical technologies. The consortium brings together medical technology manufacturers, researchers, regulators, payers, patients, and health care providers as trusted collaborators to solve complex challenges in the scientific and technical disciplines that propel medical technology development, approval, adoption, and access. MDIC’s work improves regulatory pathways, advances medical device quality, enhances patient safety and access, and facilitates the development of better evidence for approval, coverage, and utilization decisions. For more information, visit http://www.mdic.org.

Funding for NESTcc was made possible, in part, by the Food and Drug Administration through grant (U01 FD 006292). Views expressed in written materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government.