National Evaluation System for health Technology Coordinating Center (NESTcc) Partners with Aetion to Transform the Role of RWE for Medical Devices

Leading RWE platform Aetion to support the development of NESTcc's Analytics Core offering, contributing to NESTcc's RWE initiatives

ARLINGTON, Va. and NEW YORK, April 21, 2022 /PRNewswire/ -- Today, the National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), announced a first-of-its-kind, five-year strategic partnership with Aetion, a leading 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," said 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. Food and Drug Administration's (FDA) 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. Leading the Analytics Core development efforts are NESTcc's Sandra Siami; Daniel Caños, Director, Office of Clinical Evidence and Analysis, OPEQ, Center for Devices and Radiological Health (CDRH) at the FDA; and Christian Howell, VP/GM, Medical Devices and Diagnostics at Aetion.

"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," said 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."

"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," said Carolyn Magill, CEO, Aetion. "We have the opportunity to transform how data from medical devices can be used to generate insights."

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 real-world 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^®.

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.

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 promote public health through science and technology and to enhance trust and confidence among stakeholders. MDIC works in the pre-competitive space to facilitate development of methods, tools and approaches that enhance understanding and improve evaluation of product safety, quality and effectiveness. Its initiatives improve product safety and patient access to cutting-edge medical technology while reducing cost and time to market. For more information, visit http://www.mdic.org.

Funding for NESTcc was made possible, in part, by the U.S. Food and Drug Administration through grant (U01FD006292). 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.

Aetion is a healthcare analytics company that delivers real-world evidence for the manufacturers, purchasers, and regulators of medical treatments and technologies. The Aetion Evidence Platform® analyzes data from the real world to produce transparent, rapid, and scientifically validated answers on safety, effectiveness, and value. Founded by Harvard Medical School faculty members with decades of experience in epidemiology and health outcomes research, Aetion informs healthcare's most critical decisions—what works best, for whom, and when—to guide product development, commercialization, and payment innovation. Learn more at aetion.com and follow us at @aetioninc.

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