title: Medical device innovation: prospective solutions for an ecosystem in crisis. Adding a professional society perspective.
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.
authors: Duke University Medical Center/Duke Clinical Research Institute, 2400 Pratt Street, Durham, NC 27705, USA. mitchell.krucoff@duke.edu
authors: Mitchell W
authors: MW
authors: Krucoff
authors: Ralph G
authors: RG
authors: Brindis
authors: Patricia K
authors: PK
authors: Hodgson
authors: Michael J
authors: MJ
authors: Mack
authors: David R
authors: DR
authors: Holmes
mesh_terms: D003299:Cooperative Behavior; D018795:Device Approval / Q000331:legislation & jurisprudence*; D004059:Diffusion of Innovation; D004864:Equipment and Supplies; D006301:Health Services Needs and Demand; D006801:Humans; D012306:Risk; D012958:Societies, Scientific; D013997:Time Factors; D014481:United States