Upload
ralph-pearson
View
214
Download
0
Tags:
Embed Size (px)
Citation preview
11
Critical Path Research: Critical Path Research: Getting New Technology from Getting New Technology from
Bench to BedsideBench to BedsideA Device PerspectiveA Device Perspective
FDA Science BoardFDA Science BoardNovember 5, 2004November 5, 2004
Dan SchultzDan SchultzDirector, CDRHDirector, CDRH
Role of FDARole of FDA
Establish Establish reasonablereasonable
assurance of the safety and assurance of the safety and
effectiveness of medical effectiveness of medical
devices marketed in the U.S.devices marketed in the U.S.
33
HHS/FDA/CDRH
What is a “Device”?What is a “Device”?
44
A Computer You Can SwallowA Computer You Can Swallow
55
A Computer That Helps A Computer That Helps You HearYou Hear
66
Devices that Measure Glucose Devices that Measure Glucose Levels and Deliver Insulin to Levels and Deliver Insulin to
“Communicate”“Communicate”
77
Miniaturized Electrical StimulatorsMiniaturized Electrical Stimulators
Pacemakers
88
Drug-Eluting StentsDrug-Eluting Stents
ComponentsComponents
Stent Platform Stent Platform & Delivery & Delivery SystemSystem
Carrier(s)Carrier(s)
DrugDrug
99
New TechnologyNew Technology
Important TrendsImportant Trends– MiniaturizationMiniaturization– Intelligent DevicesIntelligent Devices– Designed for Consumer UseDesigned for Consumer Use– Minimally invasiveMinimally invasive– Biotechnology RevolutionBiotechnology Revolution
Genomics, ProteomicsGenomics, ProteomicsBiological Medical DevicesBiological Medical Devices
– New MaterialsNew Materials– Combination ProductsCombination Products– Disruptive TechnologiesDisruptive Technologies
That change how we do businessThat change how we do businessThat change how medical devices That change how medical devices deliver valuedeliver value
1010
CDRH Vision – Total Product Life CycleCDRH Vision – Total Product Life Cycle
1111
Devices are DifferentDevices are Different
DrugsDrugs– Pure moleculesPure molecules– ToxicologyToxicology– Short half-lifeShort half-life– Long market lifeLong market life– Drug interactionsDrug interactions– Wrong Drug / DoseWrong Drug / Dose– Clinically studiedClinically studied– Good Manufacturing Good Manufacturing
Practices (cGMP)Practices (cGMP)
DevicesDevices– Complex componentsComplex components– BiocompatibilityBiocompatibility– Durable EquipmentDurable Equipment– Rapid product cyclesRapid product cycles– MalfunctionMalfunction– User ErrorUser Error– Bench studiedBench studied– Quality Systems Quality Systems
(ISO 9000)(ISO 9000)
1212
Critical Path is Different for DevicesCritical Path is Different for Devices
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
1313
0
2000
4000
6000
8000
10000
12000
14000
16000
1998 1999 2000 2001 2002 2003 2004
Ophthalmic
Eletromedical
X-Ray
Dental
Surgical
Instruments
Diagnostics
Dun & Bradstreet Medical Device Firm Data
Medical Device Industry GrowthMedical Device Industry GrowthNumber of Manufacturers by YearNumber of Manufacturers by Year
1414
Sales Volume GrowthSales Volume Growth(Billions of Dollars)(Billions of Dollars)
0
50
100
150
200
250
300
350
1998 2000 2003 2004Year
Bil
lio
ns
of
Do
llar
s Ophthalmic
Electromechanical
X-Ray
Dental
Surgical
Instruments
Diagnostics
Note: No Economic Adjustment to Dollar Value
1515
Device Industry Continues to Grow Device Industry Continues to Grow in FY 04in FY 04
Dun and Bradstreet FY 04 data shows the device Dun and Bradstreet FY 04 data shows the device industry grew from 13,579 to 14,937 firms with about industry grew from 13,579 to 14,937 firms with about $320 billion in sales.$320 billion in sales.
Innovation is alive and well!Innovation is alive and well!
20% annual turnover in individual device firms. 20% annual turnover in individual device firms.
FDA-industry interaction is more important than FDA-industry interaction is more important than ever. FDA needs to keep guidances and reviewers ever. FDA needs to keep guidances and reviewers up to date.up to date.
1616
Innovative Science-based Strategies at Innovative Science-based Strategies at WorkWork
LeveragingLeveraging– Breast Cancer (DMIST): Screening and Digital Breast Cancer (DMIST): Screening and Digital
MammographyMammography– Medical Device Fellowship ProgramMedical Device Fellowship Program
Objective Performance CriteriaObjective Performance Criteria– Heart valvesHeart valves– Hip implantsHip implants
Novel Trial DesignsNovel Trial Designs– Bayesian StatisticsBayesian Statistics– ROC CurvesROC Curves
Guidance DevelopmentGuidance Development
1717
88
18
106
34
0
20
40
60
80
100
120
140
160
With Guidance Without Guidance
Mfr. Time
FDA Time
Da
ys
*Based on all 510(k)s (1,644) with SE decisions during FY 2002 that were for Class II devices eligible for third party review, excluding special and 3rd party 510(k)s
106
140
(n = 1,021) (n = 623)
Comparison of 510(k) Average Review TimesComparison of 510(k) Average Review Timesfor Devices With and Without Guidancefor Devices With and Without Guidance**
E Rechen, 5/03
1818
Original PMA Milestones:Original PMA Milestones:2-cycle Scenario2-cycle Scenario
Filing Rev
Scientific Review
Panel Planning
Closeout Review
PMA Received
Panel Go/NoGo
Panel Meeting
Filing Letter
Final Decision
320 days
Major Def.
Letter
Scientific Review
Clock Stops
Status Letter
Interactive Review
Consults Complete
1919
Original PMA Milestones:Original PMA Milestones:1-cycle Scenario1-cycle Scenario
Filing Review
Scientific Review
Panel Planning
Closeout Review
PMA Received
Panel Go/No Go
Panel Meeting
Filing Letter
Final Decision
180 days
StatusLetter
Consults Complete
Interactive Review
2020
The rest of the story…The rest of the story…
2121
Boston Scientific Stent Recall Grows to 96K Units
FDA Is Reviewing Reports of Trouble With
Taxus Stent Boston Scientific's Older Stents
Draw Scrutiny of FDA
Boston Scientific Expands Recall of Troubled Stent
FDA won't expand recall of stents
FDA Temperature up over Cordis
Drug-coated stents may face additional FDA scrutiny
FDA Advises Physicians of Adverse Events Associated with Cordis Cypher Coronary Stents
2222
Goal: Prioritize Actions on GMP Risks Correlating to Patient Risks
RISK
Pro
ces
ses
In
spe
ctio
n R
isk
RISK
Qu
alit
y (
Pat
ien
t)
Fa
cto
rs
GMP Patient
2323
Postmarket Questions of InterestPostmarket Questions of Interest
Long Term SafetyLong Term Safety
Performance in Community PracticePerformance in Community Practice
Change in User SettingChange in User Setting
Rare/Unexpected EventsRare/Unexpected Events
Rates of Anticipated Adverse EventsRates of Anticipated Adverse Events
Human Factors Issues – Use ErrorHuman Factors Issues – Use Error
Off-Label UseOff-Label Use
2424
Achieving Pre/Postmarket BalanceAchieving Pre/Postmarket Balance
2525
Why Balance WorksWhy Balance Works
Speeds Product to Market by Moving Some Speeds Product to Market by Moving Some Premarket Requirements to PostmarketPremarket Requirements to Postmarket
Offers Added Assurance to FDA and Offers Added Assurance to FDA and Advisory Panel Advisory Panel
Free Up ODE Staff for Premarket Review Free Up ODE Staff for Premarket Review
Generates Data for Next GenerationGenerates Data for Next Generation
Generates Data for Enhanced LabelingGenerates Data for Enhanced Labeling
2626
Postmarket Studies - PresentPostmarket Studies - Present
Ill-ConceivedIll-Conceived
Not InitiatedNot Initiated
Not CompletedNot Completed
Not TrackedNot Tracked
Not Enforced Not Enforced
2727
Postmarket Studies - FuturePostmarket Studies - Future
Better Designs Better Designs
Standardized Reporting SystemStandardized Reporting System
Better TrackingBetter Tracking
Make Status of Studies PublicMake Status of Studies Public
2828
Life Sciences LaboratoryLife Sciences Laboratory
Awards2004, GSA Construction Excellence, Projects Over $25 Million
2004, Washington Building Council, Craftsmanship Award (Mechanical / HVAC-Sheet Metal, Mechanical / Plumbing, Mechanical / HVAC-Piping)
2929
Critical Path Projects Being DevelopedCritical Path Projects Being Developed
Establishing a pedigreed and credentialed blood Establishing a pedigreed and credentialed blood panel that could be used for assessing the panel that could be used for assessing the sensitivity/specificity of new hepatitis assayssensitivity/specificity of new hepatitis assays
Developing computer models of human physiology Developing computer models of human physiology that allow testing and soft failure of peripheral that allow testing and soft failure of peripheral vascular stents before animal and human studies are vascular stents before animal and human studies are ever consideredever considered
Developing a clear regulatory path with consensus Developing a clear regulatory path with consensus from the Obstetrics community for intrapartum fetal from the Obstetrics community for intrapartum fetal diagnostic devicesdiagnostic devices
3030
Critical Path Projects Being DevelopedCritical Path Projects Being Developed
Establishing agreed pathways for the Establishing agreed pathways for the statistical validation of surrogate markersstatistical validation of surrogate markers
Working with Medical Specialty Working with Medical Specialty Organizations to develop practice guidelines Organizations to develop practice guidelines for appropriate monitoring of permanently for appropriate monitoring of permanently implanted devices implanted devices
Obtaining consensus on the extent of Obtaining consensus on the extent of neurotoxicity testing for neural tissue neurotoxicity testing for neural tissue contacting materialscontacting materials
3131
SummarySummary
Steady progress towards meeting review Steady progress towards meeting review performance goals and TPLC strategic goals performance goals and TPLC strategic goals
Success is achievable but highly resource-intensiveSuccess is achievable but highly resource-intensive
CDRH continues to seek innovative methods and CDRH continues to seek innovative methods and partnerships for evaluating new technology based partnerships for evaluating new technology based on sound science in a least burdensome manner on sound science in a least burdensome manner
Critical path will further our existing efforts to Critical path will further our existing efforts to achieve the right regulatory balance and ensure the achieve the right regulatory balance and ensure the safety and effectiveness of medical devicessafety and effectiveness of medical devices
3232
CDRH Vision – Total Product Life CycleCDRH Vision – Total Product Life Cycle