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

Healthc (Amst). 2017 Dec;5(4):158-164. doi: 10.1016/j.hjdsi.2016.10.004. Epub 2016 Dec 6.

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.%.

Keywords: Data standards; KeywordsInformatics; Medical device; Product lifecycle; Unique device identification.

MeSH terms

  • Advisory Committees / trends
  • Cooperative Behavior*
  • Equipment Design / methods*
  • Equipment Design / standards
  • Equipment Safety / standards
  • Equipment Safety / trends
  • Equipment and Supplies / standards*
  • Humans
  • United States
  • United States Food and Drug Administration / organization & administration
  • United States Food and Drug Administration / trends