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?