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Bringing Medical Devices to the Market Paths and Pitfalls. By Daniel R. Matlis and David J. Lennard February 21 st , 2007. Agenda. Business Issues Facing The Device Industry FDA Requirements For Medical Devices Medical Device Submission Vehicles Same Or Novel? - PowerPoint PPT Presentation
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AXENDIA
Bringing Medical Devices to the MarketBringing Medical Devices to the Market
Paths and Pitfalls
By
Daniel R. Matlisand
David J. Lennard
February 21st, 2007
Copyright 2007 by Axendia, Inc. Prepared for UCKIZ, February 21st, 2007 2
AXENDIA
AgendaAgenda
Business Issues Facing The Device Industry
FDA Requirements For Medical Devices
Medical Device Submission Vehicles
Same Or Novel?
Design Changes: Knowing When To Stop
Discussion
Copyright 2007 by Axendia, Inc. Prepared for UCKIZ, February 21st, 2007 3
AXENDIA
About the SpeakersAbout the SpeakersDavid J. Lennard
30 years experience in Life-Sciences25 years with Johnson & JohnsonWorked in project management, manufacturing, product/process development, clinical research, medical device reporting, product liability, regulatory affairs and quality assurance and complianceHolds two U.S. Patents
Daniel R. Matlis16 Years Experience in Life-Sciences
Involved in projects spanning R&D, Manufacturing, Regulatory Compliance, Business Development Sales, Marketing and Information Technology. Governance, Risk Management and ComplianceComputer System and Software Compliance
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Business Issues FacingBusiness Issues Facingthethe
Device Industry Device Industry
Copyright 2007 by Axendia, Inc. Prepared for UCKIZ, February 21st, 2007 5
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Business IssuesBusiness IssuesMarket Factors
ReimbursementIntellectual PropertyManufacturing FactorsImport / Export Laws
40% of approved device firms manufacture abroadSales, Marketing and Licensing
Better to be first than BestKnow your buyerKnow your competition
Regulatory FactorsDevice DevelopmentStudies conducted world-widePost Marketing Vigilance is a world-wide networkApplication formats are becoming harmonizedInspectional Methods are converging
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FDA RequirementsFDA Requirementsforfor
Medical DevicesMedical Devices
Copyright 2007 by Axendia, Inc. Prepared for UCKIZ, February 21st, 2007 7
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FDA’s Role in Technology and FDA’s Role in Technology and InnovationInnovation
Technology and Innovation Challenges
Role of FDA Meeting the Challenge
Accelerated Pace of Technology and Innovation
Complexity of New Technology
Establishing safety and effectiveness of complex technologies faster and cost-effectively
Assuring postmarket medical device safety by identifying adverse events so rare or that occur under specific conditions
Communicating medical device existence and usefulness to the public
CDRH Strategic Planning
Meeting MDUFMA Goals
Strengthening our workforce for the 21st century
Enhancing knowledge management
Achieving pre/postmarket balance
Conducting business in an open and transparent manner
Copyright 2007 by Axendia, Inc. Prepared for UCKIZ, February 21st, 2007 8
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Regulatory Process DifferencesRegulatory Process Differences
Drugs Biologics Devices
FDA Center CDER CBER CDRH
R&D Discover Identify Design
Primary mode of effect Chemical Metabolic Mechanical or
Electrical
Biological issuesPharmacokineticT
oxicitySystemic
ToxicitySystemic & Local
BiocompatibilityLocal
Good Manufacturing
Practice
cGMP21 CFR Part 210,
211
cGMP21 CFR Part 211
QSR21 CFR 820
Manufacturing Process
Batch (Solid Dose, creams, ointments,
injectable)Batch (Injectable)
Batch (Simple)Serialized (Complex)
Adverse Event Reporting
Adverse Event Reporting System
(AERS)
Adverse Event Reporting System
(AERS)
Medical Device Reporting
(MDR)
Copyright 2007 by Axendia, Inc. Prepared for UCKIZ, February 21st, 2007 9
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Patchwork of Regulatory RequirementsPatchwork of Regulatory Requirements
Food and Drug AdministrationSafetyEffectivenessClinical utility
Hospital and Clinical LaboratoryFDAHealth Care Financing Administration (HCFA) Clinical Laboratory Improvement Amendments (CLIA)Mammography Quality Standards Act (MQSA)
Other AuthoritiesFederal Communications Commission (wireless, telemetry)Nuclear Regulatory Commission (Nuclear radiation)
Rinse and Repeat for every country you plan to market in
Copyright 2007 by Axendia, Inc. Prepared for UCKIZ, February 21st, 2007 10
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The Basic Regulatory RequirementsThe Basic Regulatory Requirements
Manufacturers of medical devices distributed in the U.S. must comply with:
Premarket Notification 510(k), unless exempt, or Premarket Approval (PMA),
Establishment registration on form FDA-2891
Medical Device Listing on form FDA-2892
Quality System Regulation (QSR)
Labeling Requirements
Medical Device Reporting (MDR)
Copyright 2007 by Axendia, Inc. Prepared for UCKIZ, February 21st, 2007 11
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Pre-ApprovalPre-Approval510(k) Submission Components
Medical Device User Fee Cover Sheet
CDRH Premarket Review Submission Cover Sheet (voluntary)
510(k) Cover Letter
Executive Summary
Indications for Use Statement
510(k) Summary or 510(k) Statement
Truthful and Accuracy Statement
Class III Summary and Certification (if Applicable)
Financial Certification or Disclosure Statement
Device Description
Substantial Equivalence
Labeling
Sterilization and Shelf Life
Biocompatibility
Software (if Applicable)
Electromagnetic Compatibility and Electrical Safety (if Applicable)
Performance Testing
Copyright 2007 by Axendia, Inc. Prepared for UCKIZ, February 21st, 2007 12
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Post-ApprovalPost-Approval
Quality System Regulation 21 CFR Part 820
Regulates methods used in & facilities and controls used for:Designing
Purchasing
Manufacturing
Packaging
Labeling
Storing
Installing
Servicing
Manufacturing facilities undergo FDA inspections to assure compliance with the QSR
Copyright 2007 by Axendia, Inc. Prepared for UCKIZ, February 21st, 2007 13
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Risk-based InspectionsRisk-based Inspections
RISK
Pro
ce
ss
es
In
sp
ec
tio
n R
isk
QSR
RISK
Qu
ali
ty (
Pa
tie
nt)
F
ac
tors
Patient Safety
No Correlation
RISK
Pro
ce
ss
es
In
sp
ec
tio
n R
isk
RISK
Qu
ali
ty (
Pa
tie
nt)
F
ac
tors
QSR
High Correlation
Risk Based Inspection Approach
Traditional Inspection Approach
Patient Safety
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Medical Device Medical Device Submission VehiclesSubmission Vehicles
Copyright 2007 by Axendia, Inc. Prepared for UCKIZ, February 21st, 2007 15
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No GuaranteesNo Guarantees
Even if you do all the right things, there are no guarantees
FDA is “people”
Target submission to facilitate review
Focus your energies on meeting requirements, not working around them
Copyright 2007 by Axendia, Inc. Prepared for UCKIZ, February 21st, 2007 16
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Who Decides Device Classification?Who Decides Device Classification?
FDA established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels.
868 Anesthesiology870 Cardiovascular862 Clinical Chemistry and Clinical Toxicology872 Dental874 Ear, Nose, and Throat876 Gastroenterology and Urology878 General and Plastic Surgery880 General Hospital and Personal Use864 Hematology and Pathology866 Immunology and Microbiology882 Neurology884 Obstetrical and Gynecological886 Ophthalmic888 Orthopedic890 Physical Medicine892 Radiology
Copyright 2007 by Axendia, Inc. Prepared for UCKIZ, February 21st, 2007 17
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Class I: less stringent classificationClass I: less stringent classification
47% of medical devices fall under this category Subject to general controls
Premarket Notification 510(k), unless exempt74% of the Class I devices are exempt from the premarket notification process
Establishment registrationDevice Registration & ListingQuality System (QS) regulation (Good Manufacturing Practices –GMP’s) Labeling requirements
Misbranding
Copyright 2007 by Axendia, Inc. Prepared for UCKIZ, February 21st, 2007 18
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Class I DeviceClass I Device
Root canal post
Dental floss
Tongue depressor
Surgeons glove
Copyright 2007 by Axendia, Inc. Prepared for UCKIZ, February 21st, 2007 19
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Class II: Need to meet performance Class II: Need to meet performance standardsstandards
43% of medical devices fall under this category
In addition to general controls Class II require:
post-market surveillance
Copyright 2007 by Axendia, Inc. Prepared for UCKIZ, February 21st, 2007 20
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Class II DevicesClass II Devices
Oxygen mask
Powered wheelchair
Skull clamp
Ultrasonic imager
Copyright 2007 by Axendia, Inc. Prepared for UCKIZ, February 21st, 2007 21
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Class III DevicesClass III Devices
10% of medical devices fall under this category
Class III are those devices for which there is not enough information to show that general controls and performance standards would ensure their safety and effectiveness these include:
devices implanted in the bodylife supporting or sustaining devices
Copyright 2007 by Axendia, Inc. Prepared for UCKIZ, February 21st, 2007 22
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Class III DevicesClass III Devices
Intraocular lens
Heart valve
Infant radiant warmer
Ventricular bypass device
Blood cell separator
Pacemaker
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Same or NovelSame or Novel
Copyright 2007 by Axendia, Inc. Prepared for UCKIZ, February 21st, 2007 24
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Same or NovelSame or Novel
The 510(k) paradox Proving EquivalencyDifferent but not too different
If you goal is to run a businessLet the pendulum swing to approvableThen iterate for improvements
Systems Approach to bringing device to marketInvolve all the key stake holder from the beginning
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Dealing with Design ChangesDealing with Design ChangesKnowing when to StopKnowing when to Stop
Copyright 2007 by Axendia, Inc. Prepared for UCKIZ, February 21st, 2007 26
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Knowing When to StopKnowing When to Stop
Drawing the line in the sand
Don’t wait for perfect!Safe and effective
Be strict on setting release date goals
Copyright 2007 by Axendia, Inc. Prepared for UCKIZ, February 21st, 2007 27
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Key PointsKey Points
Be familiar with the 510(k) regulationsCheck for CDRH Guidance Documents:
AdministrativeDevice SpecificGeneral Scientific Concerns
SoftwareEMCMaterial Safety
Submission ChecklistsConsider FDA-recognized consensus standards
Copyright 2007 by Axendia, Inc. Prepared for UCKIZ, February 21st, 2007 28
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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
Don’t look for ShortcutsDon’t look for Shortcuts
Copyright 2007 by Axendia, Inc. Prepared for UCKIZ, February 21st, 2007 29
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DiscussionDiscussionContact Information
David J. Lennardemail: [email protected]: (215) 262-3582
Daniel R. Matlisemail: [email protected]: (215) 262-8037
website: www.axendia.com
Journal: http://LS-Panorama.axendia.com