Author + information
- Received November 3, 2011
- Revision received March 22, 2012
- Accepted March 22, 2012
- Published online July 1, 2012.
- Mitchell W. Krucoff, MD⁎,⁎ (, )
- Ralph G. Brindis, MD, MPH†,
- Patricia K. Hodgson, BA⁎,
- Michael J. Mack, MD‡ and
- David R. Holmes Jr, MD§
- ↵⁎Reprint requests and correspondence
: Dr. Mitchell W. Krucoff, Duke Clinical Research Institute, 508 Fulton Street, Room A3006, Durham, North Carolina 27705
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.
The authors have reported that they have no relationships relevant to the contents of this paper to disclose. Dean Kereiakes, MD, served as Guest Editor for this paper.
- Received November 3, 2011.
- Revision received March 22, 2012.
- Accepted March 22, 2012.
- American College of Cardiology Foundation