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Past Event

The future of medical device safety and innovation

Past Event

Welcome and Opening Remarks

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.


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


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

Closing Remarks


Congressional Leadership in Innovation and Regulation


Clay Alspach

Chief Health Counsel - U.S. House of Representatives


Eric Flamm

Detailee, FDA - U.S. House of Representatives



Clay Alspach

Chief Health Counsel - U.S. House of Representatives


Eric Flamm

Detailee, FDA - U.S. House of Representatives

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


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