The National Evaluation System for Health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), announced a five-year strategic partnership with Aetion, a real-world evidence (RWE) analytics provider, to advance the use of RWE in the medical device and diagnostics ecosystem.
“NESTcc has made great strides over the last several years to advance the use of RWE,” says Sandra Siami, senior vice president at MDIC and head of NESTcc. “As we continue to develop the national evaluation system and establish standards for evidence generation, Aetion brings to NESTcc best-in-class analytics technology and expertise to accelerate RWE innovation and scale.”
As part of this strategic partnership, Aetion will serve as a collaborator in the development of NESTcc’s Analytics Core, an array of services, capabilities and partners that enhance the ability to catalyze RWE in medical devices.
Aetion’s technology, the Aetion Evidence Platform, will be used as an analytics engine in sponsor-funded NESTcc evidence generation. Under the agreement, NESTcc will also leverage Aetion’s expertise in the development and execution of the Active Surveillance Program, part of the U.S. FDA’s 2018 Medical Device Safety Action Plan.
In 2016, the FDA awarded a cooperative agreement to MDIC to establish NESTcc, and the Agency continues to be an active participant.
“This partnership reflects CDRH’s continued efforts to prioritize RWE in decision making as it relates to bringing new products to market, evaluating the safety and effectiveness of existing products for new uses, and ongoing surveillance of the performance and safety of products once approved,” says Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. “As NESTcc, Aetion and CDRH continue to build upon the industry’s use of real-world data, the goal will always be to protect and promote public health.”
Aetion first began working with the FDA in May 2020 through a research collaboration to advance the understanding of and response to COVID-19 using RWE medical device data. In October 2021, the Agency then announced that it would contract with Aetion to develop a framework and system of studies for the rapid assessment of COVID-19 inpatient medical products using the Aetion Evidence Platform.
“Providing the medical device and diagnostic ecosystem with a platform to generate high-quality evidence quickly and efficiently enables better clinical outcomes. We are honored to work with a leader like NESTcc, with a demonstrated track record of improving outcomes for patients,” says Carolyn Magill, CEO, Aetion. “We have the opportunity to transform how data from medical devices can be used to generate insights.”