The future of medical device safety and innovation
Past Event
Welcome and Opening Remarks
Welcome and Opening Remarks
Creating a Viable National Medical Device Postmarket Surveillance System
Supporting Medical Device Innovation
Congressional Leadership in Innovation and Regulation
Leveraging Current Efforts to Build a Long-Term System
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.
Click here to download the National Medical Device Planning Board’s February 2015 report.
Agenda
Opening Remarks
Jeffrey Shuren
Director, Center for Devices and Radiological Health - U.S. Food and Drug Administration
Creating a Viable National Medical Device Postmarket Surveillance System
Kathleen Blake
Vice President, Performance Improvement - American Medical Association
J. Marc Overhage
Chief Medical Informatics Officer - Cerner Health Services
Omar Ishrak
Chairman and Chief Executive Officer - Medtronic plc
Bill Murray
President and Chief Executive Officer - Medical Device Innovation Consortium
Lewis Sandy
Executive Vice President, Clinical Advancement - UnitedHealth Group
Alan Guttmacher
Director, Eunice Kennedy Shriver National Institute of Child Health and Human Development - National Institutes of Health
Alan Balch
Chief Executive Officer - Patient Advocate Foundation
Jodi G. Daniel
Director, Office of Policy, Office of the National Coordinator for Health Information Technology - U.S. Department of Health and Human Services
Supporting Medical Device Innovation
Aaron V. Kaplan
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
Ross A. Jaffe
Managing Director - Versant Ventures
Michael Mussallem
Chairman and Chief Executive Officer - Edwards Lifesciences
Closing Remarks
Welcome
Congressional Leadership in Innovation and Regulation
Clay Alspach
Chief Health Counsel - U.S. House of Representatives
Wade Ackerman
Senior FDA Counsel - U.S. Senate
Eric Flamm
Detailee, FDA - U.S. House of Representatives
Grace Stuntz
FDA Policy Advisor - U.S. Senate
Lunch
Clay Alspach
Chief Health Counsel - U.S. House of Representatives
Wade Ackerman
Senior FDA Counsel - U.S. Senate
Eric Flamm
Detailee, FDA - U.S. House of Representatives
Grace Stuntz
FDA Policy Advisor - U.S. Senate
Leveraging Current Efforts to Build a Long-Term System
Mitchell Krucoff
Professor of Medicine and Cardiology; Director, Cardiovascular Devices Unit and eECG Core Laboratory - Duke University Medical Center; Duke Clinical Research Institute
Richard Platt
Professor and Chair, Department of Population Medicine - Harvard Pilgrim Health Care Institute
Carmella Bocchino
Executive Vice President of Clinical Affairs and Strategic Planning - America's Health Insurance Plans
Joe Selby
Executive Director - Patient-Centered Outcomes Research Institute
Sally Okun
Vice President for Advocacy, Policy and Patient Safety - PatientsLikeMe
More Information
To subscribe or manage your subscriptions to our top event topic lists, please visit our event topics page.
