title: Advancing medical device innovation through collaboration and coordination of structured data capture pilots: Report from the Medical Device Epidemiology Network (MDEpiNet) Specific, Measurable, Achievable, Results-Oriented, Time Bound (SMART) Think Tank.
abstract: The Medical Device Epidemiology Network (MDEpiNet) is a public private partnership (PPP) that provides a platform for collaboration on medical device evaluation and depth of expertise for supporting pilots to capture, exchange and use device information for improving device safety and protecting public health. The MDEpiNet SMART Think Tank, held in February, 2013, sought to engage expert stakeholders who were committed to improving the capture of device data, including Unique Device Identification (UDI), in key electronic health information. Prior to the Think Tank there was limited collaboration among stakeholders beyond a few single health care organizations engaged in electronic capture and exchange of device data. The Think Tank resulted in what has become two sustainable multi-stakeholder device data capture initiatives, BUILD and VANGUARD. These initiatives continue to mature within the MDEpiNet PPP structure and are well aligned with the goals outlined in recent FDA-initiated National Medical Device Planning Board and Medical Device Registry Task Force white papers as well as the vision for the National Evaluation System for health Technology.%.
authors.affiliation: U.S. Food and Drug Administration, Silver Spring, MD, USA. Electronic address: terrie.reed@fda.hhs.gov.
authors.forename: Terrie L
authors.initials: TL
authors.lastname: Reed
authors.affiliation: Mercy Health System, Chesterfield, MO, USA.
authors.forename: Joseph P
authors.initials: JP
authors.lastname: Drozda
authors.affiliation: Society of Interventional Radiology, Pittsburgh, PA, USA.
authors.forename: Kevin M
authors.initials: KM
authors.lastname: Baskin
authors.affiliation: Duke Clinical Research Institute, Durham, NC, USA.
authors.forename: James
authors.initials: J
authors.lastname: Tcheng
authors.affiliation: Global Healthcare Exchange, Louisville, CO, USA.
authors.forename: Karen
authors.initials: K
authors.lastname: Conway
authors.affiliation: Arizona State University, Phoenix, AZ, USA.
authors.forename: Natalia
authors.initials: N
authors.lastname: Wilson
authors.affiliation: U.S. Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Danica
authors.initials: D
authors.lastname: Marinac-Dabic
authors.affiliation: Cook Medical, Bloomington, IN, USA.
authors.forename: Theodore
authors.initials: T
authors.lastname: Heise
authors.affiliation: Duke Clinical Research Institute, Durham, NC, USA.
authors.forename: Mitchell W
authors.initials: MW
authors.lastname: Krucoff
mesh_terms: D026683:Advisory Committees / Q000639:trends; D003299:Cooperative Behavior; D004867:Equipment Design / Q000379:methods* / Q000592:standards; D004869:Equipment Safety / Q000592:standards / Q000639:trends; D004864:Equipment and Supplies / Q000592:standards*; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration / Q000458:organization & administration / Q000639:trends
keywords: Data standards; KeywordsInformatics; Medical device; Product lifecycle; Unique device identification