July 18, 2014 - Mitchell Krucoff, MD, will serve as principal investigator for the coordinating center.July 21, 2014
Medical device evaluation, especially for high-risk and implantable devices, is associated with multiple methodological and interpretative challenges. No medical device is risk-free, yet benefit/risk metrics remain controversial. This controversy reflects differences in stakeholder expectations—how patients, doctors, manufacturers, regulators, and payers consider the risks and the benefits of each device. These disagreements have the effect of hindering device innovation, technical optimization, clinical best practice, adoption, and even reimbursement decisions, and can undermine both public confidence and public health.
The Medical Device Epidemiology Network Initiative Public Private Partnership (MDEpiNet PPP), formed in 2013, provides global leadership to advance a sustainable infrastructure for patient-centered regulatory science, surveillance, and quantitative methods to improve medical device safety and effectiveness. As the network’s coordinating center, the DCRI manages a diverse group of stakeholders who are joining efforts, resources, and expertise to further knowledge about medical devices and apply innovative methods to patient-centered research and surveillance. The DCRI’s Mitchell Krucoff, MD (pictured), serves as principal investigator of the coordinating center.
Last month in Washington, DC, the Food and Drug Administration’s Center for Devices and Radiological Health announced the launch of the National Medical Device Registry Task Force, an improved national medical device surveillance system. In its role as the coordinating center for MDEpiNet, the DCRI conducted the call for nominations, the formation of an independent selection committee, and the first face-to-face meeting of the task force. Over the course of the coming year, the task force will outline a pragmatic plan for linking electronic medical device registries into a more informative national infrastructure supporting device benefit/risk evaluation and safety surveillance.
“With broad stakeholder participation in a collaborative atmosphere, the potential is to promote a national system that yields better evaluative information, less cost, and faster times to bedside by truly accruing performance and safety information through all stages of the product life cycle,” Krucoff said. “The focus of the task force, and MDEpiNet PPP more generally, is to extend this model of linked infrastructure to regulatory decisions and safety surveillance with a system that provides patients, practitioners, and other stakeholders with a unique national treasure that they can mine for their own purposes.”
“This partnership focuses on the collaborative leveraging of resources to improve and enhance evaluation of device safety and related risk/benefit issues,” Krucoff said. “The emphasis is on adding efficiency and quality to such evaluations through information gathering strategies that eliminate current gaps and fragmentation of efforts, data, and knowledge.”
In addition to Krucoff, the MDEpiNet coordinating center team at the DCRI includes Britt Barham, Terrie Reed, Brian McCourt, Princess Grimes, LaWillette Wilkins, Suzanne Pfeifer, Matthew Brennan, MD, MPH; David Kong, MD; Sana Al-Khatib, MD, MHS; James Tcheng, MD; and Kevin Schulman, MD.
The PPP recently approved a charter that defines the core of the governance and sustainability of the PPP and its mission, providing context and the organizational structure of the PPP. Think tank incubator programs and projects that focus on device-specific/disease-specific initiatives are being planned to help translate and disseminate generalizable principles that advance regulatory science in medical devices. The first think tank, scheduled for October 14-15, will launch the Predictable and Sustainable Implementation of National Registries (PASSION Registries) for cardiovascular devices program. The International Medical Device Regulators Forum reviewed and plans to approve a PPP-submitted Work Item on “Essential Informatics & Analytic Methodologies for Electronic Registry and Related Data Linkage for Medical Device Evaluation & Surveillance.”
For more information, please visit www.mdepinetppp.org/wp.
This article originally posted on the DCRI website.