AXENDIA Bringing Medical Devices to the Market Bringing Medical Devices to the Market Paths and Pitfalls By Daniel R. Matlis and David J. Lennard February

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

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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


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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


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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


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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


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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)


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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


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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)


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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


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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


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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


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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


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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


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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


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Class I DeviceClass I Device

Root canal post

Dental floss

Tongue depressor

Surgeons glove


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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


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Class II DevicesClass II Devices

Oxygen mask

Powered wheelchair

Skull clamp

Ultrasonic imager


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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


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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


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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


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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


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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


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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


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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