TY - JOUR
T1 - Medical device innovation
T2 - Prospective solutions for an ecosystem in crisis: Adding a professional society perspective
AU - Krucoff, Mitchell W.
AU - Brindis, Ralph G.
AU - Hodgson, Patricia K.
AU - MacK, Michael J.
AU - Holmes, David R.
PY - 2012/7
Y1 - 2012/7
N2 - 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.
AB - 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.
KW - innovation
KW - medical device
KW - safety
KW - society
UR - http://www.scopus.com/inward/record.url?scp=84864060430&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84864060430&partnerID=8YFLogxK
U2 - 10.1016/j.jcin.2012.03.023
DO - 10.1016/j.jcin.2012.03.023
M3 - Review article
C2 - 22814785
AN - SCOPUS:84864060430
SN - 1936-8798
VL - 5
SP - 790
EP - 796
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 7
ER -