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Donna-Bea Tillman, Ph.D Director, Office of Device Evaluation Center for Devices and Radiological Health Fostering Innovation on the Critical Path to Medical.

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Presentation on theme: "Donna-Bea Tillman, Ph.D Director, Office of Device Evaluation Center for Devices and Radiological Health Fostering Innovation on the Critical Path to Medical."— Presentation transcript:

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 Protect the public from unsafe products

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4 FDA Mission Today Protect Promote

5 The world today… Technological changes occur at lightning speed Technological changes occur at lightning speed Medical devices are more complex than ever Medical devices are more complex than ever The Internet is the new snake oil salesman The Internet is the new snake oil salesman The American public is demanding great control over healthcare decisions The American public is demanding great control over healthcare decisions The global marketplace means global regulation The global marketplace means global regulation

6 Technology trends Miniaturization Miniaturization Smart devices Smart devices Minimally invasive Minimally invasive Biotechnology revolution Biotechnology revolution Combination Products Combination Products Home use Home use Special Populations Special Populations

7 Disruptive Technologies That change the nature of medical devices That change the nature of medical devices That change how medical care is delivered That change how medical care is delivered That change health outcomes, hopefully for the better 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 Basic biomedical science investment & progress has surpassed medical product development investment and progress

9 Challenges to Innovation Challenges to Innovation We are using the evaluation tools and infrastructure of the last century… We are using the evaluation tools and infrastructure of the last century… to develop this centurys advances. to develop this centurys advances.

10 Challenges to Innovation Challenges to Innovation This has resulted in a bottleneck at the critical path for delivering new products to patients 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 basic science knowledge Leverages cumulative research experiences 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 MarketApplication

13 Why is FDA interested? Because of the significant benefit of bringing innovative products to the public faster 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 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 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 HHS/FDA/CDRH Devices

19 Devices are Different: Development Drugs Drugs Pure molecules Pure molecules Discovered Discovered Devices Devices Complex components Complex components Designed Designed

20 Devices are Different: Life-cycle Drugs Drugs Long market life Long market life Short half-life Short half-life Devices Devices Short product life-cycle Short product life-cycle Durable equipment Durable equipment

21 Devices are Different: Adverse Events Drugs Drugs Drug interactions Drug interactions Wrong drug/wrong dose Wrong drug/wrong dose Devices Devices Malfunction Malfunction User error User error

22 Devices are Different: Regulatory Requirements Drugs Drugs Clinical trial Clinical trial Clinical endpoints Clinical endpoints Devices Devices Risk-based Risk-based Surrogate endpoints Surrogate endpoints

23 Risk-Based Classification of Medical Devices Class I: simple, low risk devices Class I: simple, low risk devices General controls General controls Most exempt from premarket submission Most exempt from premarket submission

24 Risk-Based Classification of Medical Devices Class II: more complex, higher risk Class II: more complex, higher risk Special controls Special controls Premarket Notification [510(k)] Premarket Notification [510(k)] Substantial equivalence Substantial equivalence 10-15% require clinical data 10-15% require clinical data Performance testing Performance testing

25 Risk-Based Classification of Medical Devices Class III: most complex, highest risk Class III: most complex, highest risk Data soup to nuts Data soup to nuts Premarket Application [PMA] Premarket Application [PMA] Establish safety and effectiveness Establish safety and effectiveness Bench - Animal - Human Bench - Animal - Human May include post-approval study requirements May include post-approval study requirements

26 Critical Path is Different for Devices Device Regulation Device Regulation Least Burdensome Provision of FDAMA Least Burdensome Provision of FDAMA Quality Systems and Design Controls Quality Systems and Design Controls Device Innovation Process Device Innovation Process Biocompatibility Biocompatibility Iterative Process Iterative Process User learning curve User learning curve Performance and durability Performance and durability Device Industry is Represented by Small Manufacturers Device Industry is Represented by Small Manufacturers

27 Some Critical Path Tools… Biomarkers Biomarkers Bayesian statistics Bayesian statistics Animal models biomarkers Animal models biomarkers Clinical trials design Clinical trials design Computer simulations Computer simulations Quality assessment protocols Quality assessment protocols Post-market reporting Post-market reporting Suggestions??? Suggestions???

28 Medical Device Critical Path Projects of Interest Validation of biomarkers Validation of biomarkers Blood panel to assess sensitivity and specificity Blood panel to assess sensitivity and specificity Peripheral vascular stents Peripheral vascular stents Computer models of human physiology to test and predict failure (before animal and human studies) Computer models of human physiology to test and predict failure (before animal and human studies) Intrapartum fetal diagnostic devices Intrapartum fetal diagnostic devices Clear Regulatory Path -- with consensus from the Obstetrics community) Clear Regulatory Path -- with consensus from the Obstetrics community)

29 Medical Device Critical Path Projects of Interest Permanently implanted devices Permanently implanted devices Practice guidelines for appropriate monitoring -- with medical specialty organizations Practice guidelines for appropriate monitoring -- with medical specialty organizations Neural tissue contacting materials Neural tissue contacting materials Extent of neurotoxicity testing Extent of neurotoxicity testing

30 Web Address Web Addresshttp://www.fda.gov/oc/initiatives/criticalpath Open Docket Open Dockethttp://www.fda.gov/dockets/ecomments Docket # 2004N-0181 CDRH webpage (under news and events) provides links to the critical path white paper and docket CDRH webpage (under news and events) provides links to the critical path white paper and dockethttp://www.fda.gov/cdrh Are you interested?

31 One does what one is; one becomes what one does. Robert von Musil Robert von Musil Questions?


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