[name of file], 1
Lessons In Device Innovation
An Academic View
Mitchell W. Krucoff, MD, FACC Professor, Medicine/Cardiology
Duke University Medical Center
Director, Cardiovascular Devices Unit
Co-Director, CSRC
Duke Clinical Research Institute
Cardiac Safety
Research Consortium
Medical Device Innovation:
Is There A Crisis in the USA?
Rising manufacturing costs
Rising R&D costs
Dropping reimbursement
Saturated markets
OUS research “exodus”
Medical Device Development & Dissemination:
Precompetitive focus: What everyone wants
Advance of public health through innovation
Response to unmet medical needs
Better, safer devices
Efficient, predictable, transparent regulatory &
reimbursement pathways & decisions
High quality data:
Safety
Effectiveness
Clinical benefit
Best practices
Healthy & inventive medical device industry
Educated, reasonable professional & public expectations
Medical Device Development & Dissemination:
Precompetitive focus: What nobody wants
Unnecessary barriers to innovation:
Redundant, burdensome
Time delays (device “lag”)
Added R&D expense
Restricted reimbursement
Unnecessary or unsafe devices
Unrealistic professional or public
expectations
Device Innovation & Safety R&D: An Ecosystem
Regulatory authorities
Clinical trials
infrastructure
Pre- & Post-market design
& deliverables
Reimbursement
Practice guidelines &
adoption
Investment community
Pre-competitive, collaborative focus:
From “barriers” to innovation to solutions
Advances with unexpected impact
on device innovation:
Improved clinical outcomes
More sensitive safety reporting
High quality OUS research
True barriers: Economic instability
Fiscal constraints
Resource constraints
Novel study designs
Electronic infrastructure
Global collaboration
Efficiencies
ARC LAST: >500 reported trials
Cypher
Cypher Select
Taxus
Taxus Liberte
Xience
Endeavor
Resolute
Costar
Nevo
Biomatrix
Biofreedom
Absorb
Global Alignment
Professional Societies: How Can We Help?
1) Equipoise for device innovation:
How fast is fast enough?
How safe is safe enough?
2) Interface with all stakeholders: cultivate
pre-competitive collaboration
3) Align clinical & clinical research
enterprises
4) Align with regulatory and reimbursement
processes & deliverables
5) Global alignment
[name of file], 12
Lessons In Device Innovation
An Academic View
Mitchell W. Krucoff, MD, FACC Professor, Medicine/Cardiology
Duke University Medical Center
Director, Cardiovascular Devices Unit
Co-Director, CSRC
Duke Clinical Research Institute
Cardiac Safety
Research Consortium
