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    Add as FriendFostering Innovation on the Critical Path to Medical Device Development

    by: Rogers

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    1 : Donna-Bea Tillman, Ph.D Director, Office of Device Evaluation Center for Devices and Radiological Health Fostering Innovation on the Critical Path to Medical Device Development BME-IDEA Workshop, September 28, 2005
    2 : FDA Mission: Historical Basis Protect the public from unsafe products
    3 :
    4 : FDA Mission Today Protect Promote
    5 : The world today… 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
    6 : Technology trends Miniaturization Smart devices Minimally invasive Biotechnology revolution Combination Products Home use Special Populations
    7 : Disruptive Technologies 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.
    8 : Challenges to Innovation Basic biomedical science investment & progress has surpassed medical product development investment and progress
    9 : Challenges to Innovation We are using the evaluation tools and infrastructure of the last century… to develop this century’s advances.
    10 : Challenges to Innovation This has resulted in a bottleneck at the “critical path” for delivering new products to patients
    11 : Critical Path Research Leverages basic science knowledge Leverages cumulative research experiences Does not compromise safety and effectiveness evaluations
    12 : Critical Path for Medical Devices Basic Research Prototype Design or Discovery Clinical Development FDA Filing/ Approval & Launch Preparation Preclinical Development The journey from medical product candidate to full-scale production and marketing Critical Path Approval Market Application
    13 : Why is FDA interested? 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
    14 : 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.
    15 : What are the Critical Path tools? The methods and techniques used for: 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?
    16 : Devices are not drugs!
    17 : Drugs Yesterday Drugs Today Drugs Tomorrow
    18 : Devices
    19 : Devices are Different: Development Drugs Pure molecules Discovered Devices Complex components Designed
    20 : Devices are Different: Life-cycle Drugs Long market life Short half-life Devices Short product life-cycle Durable equipment
    21 : Devices are Different: Adverse Events Drugs Drug interactions Wrong drug/wrong dose Devices Malfunction User error
    22 : Devices are Different: Regulatory Requirements Drugs Clinical trial Clinical endpoints Devices Risk-based Surrogate endpoints
    23 : Risk-Based Classification of Medical Devices Class I: simple, low risk devices General controls Most exempt from premarket submission
    24 : Risk-Based Classification of Medical Devices Class II: more complex, higher risk Special controls Premarket Notification [510(k)] Substantial equivalence 10-15% require clinical data Performance testing
    25 : Risk-Based Classification of Medical Devices Class III: most complex, highest risk Data “soup to nuts” Premarket Application [PMA] Establish safety and effectiveness Bench - Animal - Human May include post-approval study requirements
    26 : Critical Path is Different for Devices Device Regulation Least Burdensome Provision of FDAMA Quality Systems and Design Controls Device Innovation Process Biocompatibility Iterative Process User learning curve Performance and durability Device Industry is Represented by Small Manufacturers
    27 : Some Critical Path Tools… Biomarkers Bayesian statistics Animal models biomarkers Clinical trials design Computer simulations Quality assessment protocols Post-market reporting Suggestions???
    28 : Medical Device Critical Path Projects of Interest Validation of biomarkers Blood panel to assess sensitivity and specificity Peripheral vascular stents Computer models of human physiology to test and predict failure (before animal and human studies) Intrapartum fetal diagnostic devices Clear “Regulatory Path” -- with consensus from the Obstetrics community)
    29 : Medical Device Critical Path Projects of Interest Permanently implanted devices Practice guidelines for appropriate monitoring -- with medical specialty organizations Neural tissue contacting materials Extent of neurotoxicity testing
    30 : 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 Are you interested?
    31 : One does what one is; one becomes what one does. Robert von Musil Questions?

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