FDA Awards CMTP Contract to Build Partnership for Medical Device Evidence Development
BALTIMORE, Maryland (April 12, 2011) The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) recently awarded a contract to the Center for Medical Technology Policy (CMTP) for developing the public-private partnership (PPP) for Medical Device Epidemiology Network (MDEpiNet).
By building a scientific infrastructure, the MDEpiNet PPP aims to bridge evidentiary gaps and develop new methodological approaches to advance FDA’s understanding of safety and effectiveness of medical devices.
This collaborative effort will leverage resources and expertise from multiple experts, decision makers and stakeholders to significantly improve the credibility, relevance and efficiency of clinical research regarding medical devices.
“MDEpiNet Initiative is indicative of FDA’s innovative approaches toward building scientific infrastructure and methodologies to facilitate decision-making and next generation product development” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “CMTP is very well suited to assist us in this endeavor.”
With its strong background in building project infrastructure and working with multiple experts and stakeholders, CMTP will assist the FDA in achieving the following fundamental objectives:
- Develop the scientific and administrative infrastructure to support a series of scientific projects under the MDEpiNet PPP.
- Identify and establish relationships with key experts in the field from multiple stakeholder groups for collaborative efforts under this partnership.
- Develop an Executive Committee to lead activities under the auspices of the MDEpiNet PPP.
- Establish and facilitate the necessary committees and working groups to ensure appropriate project implementation, management, and oversight for all projects under MDEpiNet PPP.
- Identify additional resource needs to support the partnership’s activities, including sustainable funding source(s).
- Devise a mechanism to collect and communicate feedback from partners on the development and results of implemented projects.
A critical requirement for the long-term success of the MDEpiNet PPP will be to ensure that the scientific framework and specific research questions are responsive to the needs and perspectives of decision makers, including patients, clinicians, payers and regulators.
“We are extremely pleased about this new collaboration with the FDA, and are excited about the opportunity to bring our experience in partnership development to help improve regulatory science for medical devices,” said Dr. Sean Tunis, Founder and Director of CMTP. “We believe this initiative will develop into a productive partnership to significantly expand our knowledge of medical device safety, and effectiveness.”
CMTP is a non-profit organization whose goal is to support the design and implementation of new prospective research that helps patients, clinicians and payers make informed treatment and policy decisions. CMTP serves as a neutral forum where a broad range of stakeholders can collaborate to identify important clinical questions, design appropriate studies, and develop innovative partnerships to implement these studies.
Contact:
Laura Esmail
410-547-2687 ext. 122
401 East Pratt Street, Suite 631
Baltimore, MD 21202
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