Welcome and Opening Remarks
Welcome and Opening Remarks
Creating a Viable National Medical Device Postmarket Surveillance System
Supporting Medical Device Innovation
Tens of millions of medical devices are used on a daily basis in the U.S., including pacemakers, knee replacements, and glucose test strips. It is critical for providers, patients, manufacturers and others to have access to better information about the performance of these devices. Not only will this information enhance patient safety, but it will also inform the development of new and more effective products. However, in today’s current market there are limited resources and tools available to collect this information. Through a cooperative agreement with the U.S. Food and Drug Administration (FDA), the Engelberg Center for Health Care Reform formed the National Medical Device Postmarket Surveillance System Planning Board; a multi-stakeholder group tasked with building this capability and designing a system to gather this information.
On February 23, the Engelberg Center hosted a discussion that highlighted the planning board’s long-term vision, identified key considerations and implications for stakeholders, and evaluated potential opportunities to support and sustain this initiative. The event included the release of the planning board’s preliminary report.
Vice President, Performance Improvement - American Medical Association
Chief Medical Informatics Officer - Cerner Health Services
Chairman and Chief Executive Officer - Medtronic plc
President and Chief Executive Officer - Medical Device Innovation Consortium
Executive Vice President, Clinical Advancement - UnitedHealth Group
Director, Eunice Kennedy Shriver National Institute of Child Health and Human Development - National Institutes of Health
Chief Executive Officer - Patient Advocate Foundation
Director, Office of Policy, Office of the National Coordinator for Health Information Technology - U.S. Department of Health and Human Services
Professor of Medicine in Cardiology, Director, Dartmouth Device Development Symposia, and Director of Research, Cardiology Section - Geisel School of Medicine and Dartmouth-Hitchcock Medical Center
Managing Director - Versant Ventures
Chairman and Chief Executive Officer - Edwards Lifesciences
Professor of Medicine and Cardiology; Director, Cardiovascular Devices Unit and eECG Core Laboratory - Duke University Medical Center; Duke Clinical Research Institute
Professor and Chair, Department of Population Medicine - Harvard Pilgrim Health Care Institute
Executive Vice President of Clinical Affairs and Strategic Planning - America's Health Insurance Plans
Executive Director - Patient-Centered Outcomes Research Institute
Vice President for Advocacy, Policy and Patient Safety - PatientsLikeMe
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