Medical device innovation: prospective solutions for an ecosystem in crisis. Adding a professional society perspective.

Journal Article (Journal Article)

Barriers to medical device innovation compromise timelines and costs from bench to bedside. Fragmented strategies by individual competitors are no longer sustainable. Pragmatically focused pre-competitive collaboration across stakeholders approaches innovation as an ecosystem. Desiloing experience and expertise encourages high-impact infrastructure efficiencies unique to pre-competitive constructs. Alignment of processes and objectives across the regulatory, reimbursement, clinical research, and clinical practice enterprises, with particular attention to the total product life cycle and continuous accrual of safety information, promotes more predictable equipoise for speed of access relative to residual safety concerns. Professional societies are well positioned to convene pre-competitive dialogue, facilitate alignment, and add perspective to equipoise within the innovation ecosystem.

Full Text

Duke Authors

Cited Authors

  • Krucoff, MW; Brindis, RG; Hodgson, PK; Mack, MJ; Holmes, DR

Published Date

  • July 2012

Published In

Volume / Issue

  • 5 / 7

Start / End Page

  • 790 - 796

PubMed ID

  • 22814785

Electronic International Standard Serial Number (EISSN)

  • 1876-7605

Digital Object Identifier (DOI)

  • 10.1016/j.jcin.2012.03.023


  • eng

Conference Location

  • United States