[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