Rachael Fleurence, PhD
NEST Coordinating Center Medical Device Innovation Consortium (MDIC)
Improving Evidence Generation for Medical Devices: The New National Evaluation System for Health Technology (NEST)
Pragmatic clinical trial; Clinical research; NEST; real world evidence; medical devices; MDIC
- Safe and effective devices, as well as quality of life for patients, are top priorities for NEST and the healthcare ecosystem as a whole.
- Many stakeholders in the medical device ecosystem can benefit from improved use of real-world evidence generated in routine care.
- A shifting paradigm to a “National System” approach will embed clinical research into routine care and will move from passive to active surveillance.
- NEST aims to establish partnerships that provide data to support timely and reliable development of high-quality real-world evidence.
- NEST will soon reveal its first set of demonstration projects on the use of real-world evidence in medical devices, and will identify existing gaps to target for future projects.
Health systems have identified the benefits of finding brand-specific information on devices to see how well certain types of devices function compared with others.
NEST plans to work with diagnostics and predictive technologies and is currently forming plans within that space.
The NEST Coordinating Center will collaborate with MDEpiNet, a public-private partnership with both academic and industry members, to conduct device methodology work in the future.
The role of NEST within the clinical trials space will be dependent on what its partners put forth in terms of appropriate research questions to answer.
For More Information
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