January 9, 2014 – These calls for nominations come from the Brookings Institution and the DCRI.
|Attached to this communication are calls for nominations for two coordinated, high priority initiatives intended to integrate expertise across stakeholders involved with the medical device ecosystem. In both cases the explicit intention is to emphasize broad and balanced representation of stakeholder groups.
From the Brookings Institution comes the call for nominations to the National Medical Device Postmarket Surveillance System Planning Board (Planning Board). The Planning Board will provide a mechanism to engage content experts and the public in a wide array of strategic issues, such as high-level system design considerations, creating a sustainable business model, legal and privacy policies, infrastructure stability and flexibility, high level methodological focus to support the public private partnership, as well as governance, data use and sharing, and communication concerns. This 12-month process will be coordinated through the Engelberg Center for Health Care Reform at the Brookings Institution.
From the Duke Clinical Research Institute comes the call for nominations to the National Medical Device Registries Task Force (Task Force). This entity is tasked to address the implementation of registries in postmarket surveillance and throughout the Total Product Life Cycle (TPLC), formulated through five committees targeting specific aspects of registries such as their cataloguing, informatics issues, potential linking and leveraging, and general as well as device/disease specific applications over the TPLC. This 12 month process will be coordinated through the MDEpiNet Coordinating Center at Duke University.
To ensure coordination between these efforts nominees will be reviewed, as indicated in the Calls attached, through a common process but individuals should be serving only on one of these committees.
The mandated deliverables from both the Planning Board and the Task Force efforts will be critical in the implementation of the strategy to establish national system for postmarket surveillance for medical devices.
Timelines are tight, priorities for these activities are high. We hope that you will consider both nominating yourself as well as conveying this call to other relevant experts who you think could contribute to enhancing our innovation ecosystem.
Mitchell W. Krucoff
Professor, Medicine/Cardiology Duke University Medical Center Director, Cardiovascular Devices Unit Director, eECG Core Laboratory Duke