ARLINGTON, Va. — The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), today announced MedStar Health as the newest network collaborator to join the NESTcc Research Network.
NESTcc’s research network of internationally recognized health organizations supports the generation of real-world evidence and collaboration with stakeholders across the medical device ecosystem. In partnership with its network collaborators, NESTcc curates diverse data sources and research expertise, applying rigorous methodologies and data standards to enable efficient, high-quality studies of medical devices. Studies have been developed across multiple disease areas, device classes in the 510(k) and premarket approval (PMA) pathways and all stages of the total product life cycle. NESTcc recently opened access to its research network for sponsored studies.
“MedStar Health is pleased to join as a NESTcc Network Collaborator, and we look forward to our exciting and important work together,” said Neil J. Weissman, M.D., FACC, FASE, chief scientific officer for MedStar Health and president of MedStar Health Research Institute. “Our partnership with NESTcc will allow us to utilize our clinical research expertise to advance health using real-world evidence from the delivery of care, as well as expand the scale of our impact for patients and clinicians.”
Leveraging access to electronic health records, claims, and other relevant data from 4.2 million unique patients across MedStar Health’s 10 hospitals and 300 service centers, is the executive research organization for MedStar Health, headquartered in Maryland. The Research Institute provides scientific research infrastructure and administrative and regulatory support for programs conducted at MedStar Health facilities. From bench to bedside to community, MedStar Health plans and conducts studies that advance medical knowledge and translate research into improved patient care. With more than 300 active investigators, research areas of focus include cardiovascular, health care delivery, cancer, neuroscience and rehabilitation, diabetes, women and infant service and orthopedics and sports medicine.
“NESTcc continues to transform the paradigm of clinical research, expanding access to high-quality evidence and informing clinical and regulatory decision-making to empower people with safe and effective technologies,” said Sandra Siami, MPH, senior vice president, NESTcc, MDIC. “Our growing research network is helping NESTcc set the standard for real-world evidence innovation, and MedStar Health’s diversity of data and caliber of investigators will make them a key partner and driver of excellence for us and our research sponsors.”
With the addition of MedStar Health, the NESTcc Research Network is now comprised of 16 network collaborators with access to data from more than 161 million patients.
About MedStar Health Research Institute
MedStar Health Research Institute is the research arm of MedStar Health, the largest health care provider in Maryland and the Washington, D.C., region. MHRI provides scientific, administrative and regulatory support for research programs throughout the MedStar Health system. MHRI’s expertise includes translational research into disease prevention, diagnosis and treatment. These programs complement the key clinical services and teaching programs in the 10 MedStar hospitals and other MedStar entities. For more information, visit www.MedStarResearch.org.
About MedStar Health
At MedStar Health, we use the best of our minds and the best of our hearts to serve our patients, those who care for them, and our communities. Our 30,000 associates and 4,700 affiliated physicians are committed to living this promise through our core SPIRIT values—Service, Patient first, Integrity, Respect, Innovation, and Teamwork—across our more than 300 locations including 10 hospitals, ambulatory, and urgent care centers. As the medical education and clinical partner of Georgetown University, MedStar Health is training future physician leaders to care for the whole person and is advancing care through the MedStar Health Research Institute. From our telemedicine and urgent care services to the region’s largest home health agency, we’re committed to providing high-quality health care that’s also easy and convenient for our patients. At MedStar Health—It’s how we treat people. Learn more at MedStarHealth.org.
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). The Coordinating Center seeks to support the sustainable generation and use of timely, reliable and cost-effective Real-World Evidence (RWE) throughout the medical device lifecycle, using high-quality Real-World Data (RWD) that meets robust methodological standards for the purpose of enhancing regulatory and clinical decision-making. 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 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 Food and Drug Administration through grant (3 U01 FD006292-03S1). 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.
Communications & Planning Manager, MHRI