This application proposes creation of a major innovative initiative/program on medicalcountermeasures (MCM) within the Medical Device Epidemiology Network (MDEpiNet). The focus of theproposed initiative is advance the regulatory science and support MDEpiNet academic partnership throughcollaborative projects. The initiative has two major components; 1) A major collaboration within CornellUniversity through a Patient-Centered Comparative Research program; home of the International Consortiumof Orthopedic Registries initiative and MDEpiNet science and infrastructure center, 2) Collaboration withexternal partners such as Brookings Institution and MDEpiNet academic institutions. The mission is to improvethe evidence and infrastructure for medical device evaluation both in the context of MCM and overallregulation, We develop and use various data sources to advance the safety and effectiveness of devices andincorporate a total product life cycle (TPLC) approach while continuously improving it. Our application buildsupon the extensive experience accumulated by the Cornell during the past decade including AHRQ 'devicecenter' and MDEpiNet Science and Infrastructure Center. We plan collaboration with FDA for all requirementsof this project. We plan to assist FDA by using the 'Surge Model' for various CBRN events to propose strategyfor device prioritization. Then we propose six additional aims.
In Aim 1 we propose evidence reviews toillustrate the contribution of published literature to MCM device evaluation with examples of pacemakers,defibrillators and hip implants.
In Aim 2 we use claims/administrative databases or registries to fill in the gapsin evidence. Illustrative examples include cardiac pacemakers, ICD, ventricular assist devices, insulin pumps,vacuum assisted closure devices, surgical devices.
In Aim 3 we use electronic medical records (EMR) or otherelectronic resources for MCM device evaluation. Illustrative examples include the studies of safety andeffectiveness of pacemakers, hearing aids and equipment.
In Aim 4 we advance the TPLC framework fordevice evaluation using a recent and a novel international conceptual framework developed in collaborationwith FDA for application in device regulation. We use this approach to recognize the stage of the device in thecycle of its development and derive appropriate study designs and analytical strategies to further advanceTPLC.
In Aim 5 we propose collaborative projects with other MDEpiNet participants.These projectspromote innovation and collaboration within MDEpiNet. Finally, in Aim 6 we convene relevant stakeholdersfor discussion of key issues related to MCM-priority medical devices and disseminate results of thesediscussions in brief white papers. We collaborate with the Brookings Institution and FDA to hold stakeholdermeetings, think-tanks and workshops. Through this initiative, we will serve as a dependable, adaptable, andflexible device infrastructure; a vital resource not only for MCM and regulatory research, but also forstakeholders and public-private partners, in line with other national programs such as FDA sentinel initiative.
Medical Device Epidemiology Network: Applications for Medical Countermeasure- Associated Devices Project Narrative: This application proposes creation of a major innovative initiative/program on medical countermeasures (MCM) within the Cornell's Science and Infrastructure Center for Medical Device Epidemiology Network (MDEpiNet). The initiative is a major collaboration within Cornell University and New York Presbyterian Hospital as well as external MDEpiNET partners with a history of medical device infrastructure and science projects. The mission is to improve the evidence and infrastructure for medical devices both in the context of MCM and overall regulatory context;developing or exploiting various data sources to advance the safety and effectiveness of devices and incorporating total product life cycle (TPLC) approach while continuously improving it. .
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