donna-bea tillman, ph.d director, office of device evaluation center for devices and radiological...
TRANSCRIPT
Donna-Bea Tillman, Ph.DDonna-Bea Tillman, Ph.D
Director, Office of Device EvaluationDirector, Office of Device EvaluationCenter for Devices and Radiological HealthCenter for Devices and Radiological Health
Fostering Innovation on the Fostering Innovation on the Critical Path to Medical Device Critical Path to Medical Device
DevelopmentDevelopment
BME-IDEA Workshop, September 28, 2005
FDA Mission: FDA Mission: Historical BasisHistorical Basis
Protect Protect the the public from public from unsafe unsafe productsproducts
FDA Mission TodayFDA Mission Today
ProtectPromote
The world today…The world today…
Technological changes occur at lightning Technological changes occur at lightning speedspeed
Medical devices are more complex than everMedical devices are more complex than ever The Internet is the new “snake oil” salesmanThe Internet is the new “snake oil” salesman The American public is demanding great The American public is demanding great
control over healthcare decisionscontrol over healthcare decisions The global marketplace means global The global marketplace means global
regulationregulation
Technology trendsTechnology trends
MiniaturizationMiniaturization Smart devicesSmart devices Minimally invasiveMinimally invasive Biotechnology revolutionBiotechnology revolution Combination ProductsCombination Products Home useHome use Special PopulationsSpecial Populations
Disruptive TechnologiesDisruptive Technologies
That change the nature of medical devicesThat change the nature of medical devices That change how medical care is deliveredThat change how medical care is delivered That change health outcomes, hopefully for That change health outcomes, hopefully for
the betterthe better
……that change how the industry and that change how the industry and FDA do business.FDA do business.
Challenges to InnovationChallenges to Innovation
Basic biomedical science Basic biomedical science investment & progress investment & progress has surpassed medical has surpassed medical product development product development investment and investment and progress progress
Challenges to InnovationChallenges to Innovation
We are using the We are using the evaluation tools and evaluation tools and infrastructure of the infrastructure of the last century…last century…
to develop this to develop this century’s advances.century’s advances.
Challenges to InnovationChallenges to Innovation
This has resulted in a This has resulted in a bottleneck at the “critical bottleneck at the “critical path” for delivering new path” for delivering new products to patientsproducts to patients
Critical Path Research Critical Path Research
Leverages basic Leverages basic science knowledgescience knowledge
Leverages cumulative Leverages cumulative research experiencesresearch experiences
Does not compromiseDoes not compromise
safety and safety and effectivenesseffectiveness
evaluationsevaluations
Critical Path for Medical Critical Path for Medical DevicesDevices
Basic Research
Basic Research
PrototypeDesign or Discovery
PrototypeDesign or Discovery
Clinical Development
Clinical Development
FDA Filing/Approval &
LaunchPreparation
FDA Filing/Approval &
LaunchPreparation
PreclinicalDevelopmentPreclinicalDevelopment
The journey from medical product candidate to full-scale production and
marketing
Critical PathCritical PathCritical PathCritical Path
ApprovalApprovalApprovalApprovalMarketMarket
ApplicationApplicationMarketMarket
ApplicationApplication
Why is FDA Why is FDA interested?interested?
Because of the significant benefit of Because of the significant benefit of bringing innovative products to the public bringing innovative products to the public fasterfaster
Because of our unique perspective on Because of our unique perspective on product development -- we see success, product development -- we see success, failure and missed opportunitiesfailure and missed opportunities
Because it will help us to develop guidance Because it will help us to develop guidance and standards that foster innovation and and standards that foster innovation and improve chances of successimprove chances of success
What does FDA want to What does FDA want to accomplish?accomplish?
Work together with industry, Work together with industry, academia and patient care academia and patient care
advocates advocates toto
modernize, develop and disseminate modernize, develop and disseminate solutions (tools) to address solutions (tools) to address scientific hurdles impacting scientific hurdles impacting
industry-wide product industry-wide product development.development.
What are the Critical Path What are the Critical Path tools?tools?
The methods and techniques The methods and techniques used for: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?
Devices are not drugs!
Drugs Yesterday
Drugs Today
Drugs Tomorrow
HHS/FDA/CDRH
DevicesDevices
Devices are Different: Devices are Different: DevelopmentDevelopment
DrugsDrugs Pure moleculesPure molecules DiscoveredDiscovered
DevicesDevices Complex Complex
componentscomponents DesignedDesigned
Devices are Different: Devices are Different: Life-cycleLife-cycle
DrugsDrugs Long market lifeLong market life Short half-lifeShort half-life
DevicesDevices Short product life-Short product life-
cyclecycle Durable equipmentDurable equipment
Devices are Different: Devices are Different: Adverse EventsAdverse Events
DrugsDrugs Drug interactionsDrug interactions Wrong drug/wrong Wrong drug/wrong
dosedose
DevicesDevices MalfunctionMalfunction User errorUser error
Devices are Different: Devices are Different: Regulatory RequirementsRegulatory Requirements
DrugsDrugs Clinical trialClinical trial Clinical Clinical
endpointsendpoints
DevicesDevices Risk-basedRisk-based Surrogate endpointsSurrogate endpoints
Risk-Based Classification of Risk-Based Classification of Medical DevicesMedical Devices
Class I: simple, low risk Class I: simple, low risk devicesdevices General controlsGeneral controls Most exempt from premarket Most exempt from premarket
submissionsubmission
Risk-Based Classification of Risk-Based Classification of Medical DevicesMedical Devices
Class II: more complex, higher riskClass II: more complex, higher risk Special controlsSpecial controls Premarket Notification [510(k)]Premarket Notification [510(k)] Substantial equivalenceSubstantial equivalence 10-15% require clinical data10-15% require clinical data Performance testingPerformance testing
Risk-Based Classification of Risk-Based Classification of Medical DevicesMedical Devices
Class III: most complex, Class III: most complex, highest riskhighest risk Data “soup to nuts”Data “soup to nuts” Premarket Application [PMA] Premarket Application [PMA] Establish safety and effectivenessEstablish safety and effectiveness Bench - Animal - HumanBench - Animal - Human May include post-approval study May include post-approval study
requirementsrequirements
Critical Path is Different for Critical Path is Different for DevicesDevices
Device RegulationDevice Regulation Least Burdensome Provision of FDAMALeast Burdensome Provision of FDAMA Quality Systems and Design ControlsQuality Systems and Design Controls
Device Innovation ProcessDevice Innovation Process BiocompatibilityBiocompatibility Iterative ProcessIterative Process User learning curveUser learning curve Performance and durabilityPerformance and durability
Device Industry is Represented by Device Industry is Represented by Small ManufacturersSmall Manufacturers
Some Critical Path Some Critical Path Tools…Tools…
BiomarkersBiomarkers Bayesian statisticsBayesian statistics Animal models biomarkers Animal models biomarkers Clinical trials designClinical trials design Computer simulationsComputer simulations Quality assessment protocols Quality assessment protocols Post-market reportingPost-market reporting Suggestions???Suggestions???
Medical Device Critical Path Medical Device Critical Path Projects of InterestProjects of Interest
Validation of biomarkersValidation of biomarkers Blood panel to assess sensitivity and Blood panel to assess sensitivity and
specificity specificity Peripheral vascular stents Peripheral vascular stents
Computer models of human physiology to Computer models of human physiology to test and predict failure (before animal and test and predict failure (before animal and human studies)human studies)
Intrapartum fetal diagnostic devicesIntrapartum fetal diagnostic devices Clear “Regulatory Path” -- with consensus Clear “Regulatory Path” -- with consensus
from the Obstetrics community)from the Obstetrics community)
Medical Device Critical Path Medical Device Critical Path Projects of InterestProjects of Interest
Permanently implanted devices Permanently implanted devices Practice guidelines for appropriate Practice guidelines for appropriate
monitoring -- with medical specialty monitoring -- with medical specialty organizationsorganizations
Neural tissue contacting materials Neural tissue contacting materials Extent of neurotoxicity testing Extent of neurotoxicity testing
Web AddressWeb Addresshttp://www.fda.gov/oc/initiatives/criticalpathhttp://www.fda.gov/oc/initiatives/criticalpath
Open DocketOpen Dockethttp://www.fda.gov/dockets/ecommentshttp://www.fda.gov/dockets/ecommentsDocket # 2004N-0181Docket # 2004N-0181
CDRH webpage (under news and events) provides CDRH webpage (under news and events) provides links to the critical path white paper and docketlinks to the critical path white paper and docket
http://www.fda.gov/cdrhhttp://www.fda.gov/cdrh
Are you interested?Are you interested?
One does what one is; One does what one is;
one becomes what one does.one becomes what one does. Robert von MusilRobert von Musil
Questions?Questions?