Transcript Fostering Innovation on the Critical Path to Medical Device

Fostering Innovation on the Critical
Path to Medical Device
Development
BME-IDEA Workshop, September 28, 2005
Donna-Bea Tillman, Ph.D
Director, Office of Device Evaluation
Center for Devices and Radiological Health
FDA Mission:
Historical Basis
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Protect the
public from
unsafe
products
FDA Mission Today
Promote
Protect
The world today…
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Technological changes occur at lightning speed
Medical devices are more complex than ever
The Internet is the new “snake oil” salesman
The American public is demanding great control
over healthcare decisions
The global marketplace means global regulation
Technology trends
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Miniaturization
Smart devices
Minimally invasive
Biotechnology revolution
Combination Products
Home use
Special Populations
Disruptive Technologies
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That change the nature of medical devices
That change how medical care is delivered
That change health outcomes, hopefully
for the better
…that change how the industry and
FDA do business.
Challenges to Innovation
Basic biomedical science
investment & progress
has surpassed medical
product development
investment and progress
Challenges to Innovation
We are using the
evaluation tools and
infrastructure of the last
century…
to develop this century’s
advances.
Challenges to Innovation
This has resulted in a
bottleneck at the “critical
path” for delivering new
products to patients
Critical Path Research
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Leverages basic science
knowledge
Leverages cumulative
research experiences
Does not compromise
safety and effectiveness
evaluations
Critical Path for Medical Devices
Market
Application
Basic
Research
Prototype
Design or
Discovery
Preclinical
Development
Clinical
Development
Approval
FDA Filing/
Approval &
Launch
Preparation
Critical Path
The journey from medical product
candidate to full-scale production and
marketing
Why is FDA interested?
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Because of the significant benefit of bringing
innovative products to the public faster
Because of our unique perspective on product
development -- we see success, failure and
missed opportunities
Because it will help us to develop guidance and
standards that foster innovation and improve
chances of success
What does FDA want to
accomplish?
Work together with industry, academia
and patient care advocates
to
modernize, develop and disseminate
solutions (tools) to address scientific
hurdles impacting industry-wide product
development.
What are the Critical Path tools?
The methods and techniques used
for:
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Assessment of Safety – how to predict if
a potential product will be harmful?
Proof of Efficacy - how to determine if a
potential product will have medical
benefit?
Industrialization – how to manufacture a
product at commercial scale with
consistent quality?
Devices are not drugs!
Drugs Yesterday
Drugs Today
Drugs Tomorrow
Devices
HHS/FDA/CDRH
Devices are Different:
Development
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Drugs
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Pure molecules
Discovered
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Devices
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Complex components
Designed
Devices are Different:
Life-cycle
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Drugs
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Long market life
Short half-life
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Devices
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Short product life-cycle
Durable equipment
Devices are Different:
Adverse Events
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Drugs
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Drug interactions
Wrong drug/wrong dose
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Devices
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Malfunction
User error
Devices are Different:
Regulatory Requirements
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Drugs
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Clinical trial
Clinical endpoints
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Devices
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Risk-based
Surrogate endpoints
Risk-Based Classification of
Medical Devices
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Class I: simple, low risk devices
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General controls
Most exempt from premarket
submission
Risk-Based Classification of Medical
Devices
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Class II: more complex, higher risk
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Special controls
Premarket Notification [510(k)]
Substantial equivalence
10-15% require clinical data
Performance testing
Risk-Based Classification of Medical
Devices
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Class III: most complex,
highest risk
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Data “soup to nuts”
Premarket Application [PMA]
Establish safety and effectiveness
Bench - Animal - Human
May include post-approval study
requirements
Critical Path is Different for Devices
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Device Regulation
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Device Innovation Process
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Least Burdensome Provision of FDAMA
Quality Systems and Design Controls
Biocompatibility
Iterative Process
User learning curve
Performance and durability
Device Industry is Represented by Small
Manufacturers
Some Critical Path Tools…
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Biomarkers
Bayesian statistics
Animal models biomarkers
Clinical trials design
Computer simulations
Quality assessment protocols
Post-market reporting
Suggestions???
Medical Device Critical Path
Projects of Interest
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Validation of biomarkers
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Peripheral vascular stents
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Blood panel to assess sensitivity and specificity
Computer models of human physiology to test
and predict failure (before animal and human
studies)
Intrapartum fetal diagnostic devices
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Clear “Regulatory Path” -- with consensus from
the Obstetrics community)
Medical Device Critical Path
Projects of Interest
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Permanently implanted devices
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Practice guidelines for appropriate monitoring -with medical specialty organizations
Neural tissue contacting materials
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Extent of neurotoxicity testing
Are you interested?
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Web Address
http://www.fda.gov/oc/initiatives/criticalpath
Open Docket
http://www.fda.gov/dockets/ecomments
Docket # 2004N-0181
CDRH webpage (under news and events) provides
links to the critical path white paper and docket
http://www.fda.gov/cdrh
Questions?
One does what one is;
one becomes what one does.
Robert von Musil