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

Mitchell W. Krucoff, Ralph G. Brindis, Patricia K. Hodgson, Michael J. MacK, David R. Holmes

Research output: Contribution to journalReview articlepeer-review

30 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)790-796
Number of pages7
JournalJACC: Cardiovascular Interventions
Volume5
Issue number7
DOIs
StatePublished - Jul 2012

Keywords

  • innovation
  • medical device
  • safety
  • society

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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