Implantable Medical Devices and Biocompatible Materials Industry Review

Published by: BCC Research

Published: Jun. 1, 2000 - 231 Pages

Table of Contents

Introduction

• Study Goals And Objectives
  
• Reasons For Doing The Study
  
• Contributions Of The Study
  
• Audience For The Study
  
• Scope And Format
  
• Methodology
  
• Information Sources
  
• Related Bcc Reports
  
• Bcc On-Line Services
  
• Internet
  
• Disclaimer
  

Executive Summary

• Market Segments
  
• Principal Market Forces
  

Industry Overview

• Importance Of The Industry
  
• Economic Perspective
  
• Research And Development
  
• Biomedical Engineering
  
• Basic Research
  
• Applied Research
  
• Developmental Research
  
• National Institution Of Health Bioengineering Study
  
• Artificial Hearts/Ventricular Assist Devices
  
• Heart Valves
  
• Pacemakers
  
• Defibrillators
  
• Dental Implants
  
• Breast Implants
  
• Eye Implants
  
• Cochlear Implants
  
• Biocompatible Polymers
  
• Biocompatible Metals And Alloys
  
• Biocompatible Ceramics
  
• Benchmark Events
  
• Industry Description
  
• Major Products
  
• Major Applications
  
• Pacemakers And Defibrillators
  
• Ventricular-Assist Devices (Vads)
  
• Heart Valves
  
• Artificial Joints
  
• Breast Implants
  
• Eye, Ear And Face Implants
  
• Competition
  
• Trade Associations
  
• Effects On The Future
  
• Cdrh Industry Trends Survey
  
• Computer-Related Technology
  
• Minimally Invasive Procedures
  
• Combination Device/Drug Products
  
• Organ Replacements And Assists
  
• Other Trends
  
• Impact Of Trends On The Implant Industry
  
• Keeping Pace With Medical Technology
  
• New Materials
  
• New Applications
  
• New Products
  

Regulations And Standards

• History Of Congressional Acts And Amendments
  
• Federal Food, Drug, And Cosmetic Act Of 1938
  
• The Medical Device Amendments Of 1976
  
• Clinical Laboratories Improvement Acts (Clia)
  
• Safe Medical Devices Act (Smda) Of 1990
  
• Medical Device Amendments Of 1992
  
• National Institutes Of Health Revitalization
  
• Act Of 1993
  
• Health Research Extension Act
  
• Export Reform And Enhancement Act Of 1996
  
• The Fda Modernization Act Of 1997
  
• Biomaterials Access Assurance Act Of 1998
  
• Assistive Technology Act Of 1998
  
• U.S. Government Bodies Involved With Biomaterials
  
• And Medical Devices
  
• Office Of Standards And Regulations
  
• Food And Drug Administration (Fda)
  
• Center For Devices And Radiological Health (Cdrh).
  
• Office Of Device Evaluation (Ode)
  
• Office Of Compliance (Oc)
  
• Office Of Science And Technology (Ost)
  
• Office Of Health And Industry Programs (Ohip)
  
• National Center For Toxicological Research (Nctr).
  
• Working Groups
  
• Regulations Relating To Approval Of Medical
  
• Devices
  
• Classification Of Medical Devices
  
• Preamendment-Device Equivalency
  
• Postamendment-Device Equivalency
  
• Premarket Approval For New Devices (Pma) - 510(K)
  
• Real-Time Review For Pma Supplements
  
• Product Development Protocol (Pdp)
  
• Investigational Device Exemption (Ide)
  
• Registering And Listing Products With The Fda
  
• Exempted From Fda Regisration
  
• Quality System Regulations (Good)
  
• Manufacturing Practices
  
• Good Laboratory Practices (Glps)
  
• Administrative Detention
  
• Fda Inspections
  
• Fda Reporting Requirements
  
• Repair, Replace, Refund, Recall, And Track
  
• Repair, Replace, Or Refund
  
• Recall
  
• Tracking
  
• National Cardiac Pacemaker Registry
  
• Orthopedic Implant Registry
  
• Medical Device Import And Export Regulations
  
• Importing Devices
  
• Exporting Devices
  
• How To Obtain Copies Of Fda Regulations
  
• Standards
  
• Generally Acceptable Medical Device
  
• Standards
  
• The International Electrotechnical Commission (Iec)
  
• The American National Standards Institute (Ansi)
  
• Association For The Advancement Of Medical
  
• Instrumentation (Aami)
  
• General Standards For Electronic Implantable
  
• Medical Devices
  
• Fda Testing Standards
  
• Blue Book Memorandum #G95-1
  
• The Medical Devices Standards Activities
  
• Report
  
• American Society For Testing And Materials
  
• (Astm)
  
• Astm Standards
  
• U.S. Pharmacopoeia (Usp)
  
• Usp Biocompatibility Tests
  
• General Compatibility Testing Standards
  
• Specific Standards For Device Implantation
  
• Fda Guidance Documents
  
• Japanese Standards
  
• European Standards
  
• Key Directives Issued By The European Committee For
  
• Standardization (Cen).
  
• Device Classifications
  
• Notified Bodies
  
• International Organization For
  
• Standardization (Iso)
  
• Applicable Standards For Implantable Devices
  
• Iso Medical Device Biological Evaluation
  
• Iso 10993-1: Guidance On Test Selection
  
• Iso 10993-2: Animal Welfare Requirements
  
• Iso 10993-3: Biotests For Genotoxicity, Carcinogenicity
  
• And Reproductive Toxicity
  
• Iso 10993-4: Test Selection For Interactions With Blood
  
• Iso 10993-5: Tests For Cytotoxicity - In Vitro Methods
  
• Iso 10993-6: Tests For Local Effects After Implantation
  
• Iso 10993-10: Irritation And Sensitization Test
  
• Iso 10993-11: Systemic Toxicity Test
  
• Iso 10993-14: Identification And Quantification Of
  
• Degradation Products From Ceramics
  
• The Iso Information Network
  
• Biocompatibility Test Data Sources
  
• Mutual Recognition Agreement (Mra).
  
• Corporate Concerns
  
• Regulatory Affairs
  
• Improving Or Retaining Quality Control
  
• Standards
  
• Product Liability
  

Markets By Product Types And Applications

• Prosthetic Devices
  
• Heart And Circulatory System
  
• Ventricular Assist Devices (Vads)
  
• The Market
  
• Growth Rate
  
• Factors That Influence The Market
  
• Devices
  
• Company Products And Innovations
  
• Thermo Cardiosystems, Inc.
  
• Baxter Healthcare
  
• Thoratec Laboratories
  
• Abiomed, Inc
  
• World Heart Corporation
  
• Heart Valve Prosthesis
  
• The Market
  
• Growth
  
• Factors Influencing The Market
  
• Devices
  
• Company Products And Innovations
  
• St. Jude Medical
  
• Sulzer Medica
  
• Medtronic
  
• Implantable Cardiac Defibrillator (Icd)
  
• The Market
  
• Factors That Influence The Market
  
• Devices
  
• Company Products And Innovations
  
• Guidant
  
• Medtronic
  
• St. Jude Medical
  
• Pacemakers
  
• The Market
  
• Growth Rate
  
• Factors That Influence The Market
  
• Devices
  
• Company Products
  
• Medtronic
  
• Guidant Corporation
  
• St. Jude Medical
  
• Orthopedic Implants
  
• Joint Replacements
  
• The Market
  
• Factors That Influence The Market
  
• Hip Prostheses
  
• Market Size
  
• Factors That Influence The Market
  
• Devices
  
• Hip And Knee Replacement Manufacturers
  
• Depuy
  
• Stryker Corporation
  
• Biomet
  
• Johnson&Johnson
  
• Knee Prostheses
  
• Market Size
  
• Johnson&Johnson
  
• Depuy
  
• Biomet
  
• Stryker Corporation
  
• Shoulder-Joint Implant
  
• Market Size
  
• Factors That Influence The Market
  
• Biomet
  
• Depuy
  
• Stryker
  
• Ankle-Joint Implant
  
• The Market
  
• Factors That Influence The Market
  
• Devices
  
• Wrist, Hand And Finger Implants
  
• Spinal Implants
  
• The Market
  
• Growth Rate
  
• Factors That Influence The Market
  
• Devices
  
• Sulzer Medica
  
• Depuy
  
• Biomet
  
• Stryker Corporation
  
• Bone Plates, Screws, Nails, Wires, And Other
  
• Internal Fixation Devices
  
• Growth Rate
  
• Factors That Influence The Market
  
• Devices
  
• Implant Products
  
• Bone Graft Substitutes And Bone Cement
  
• Market Size
  
• Factors That Influence The Market
  
• Devices
  
• Sulzer Medica
  
• Depuy
  
• Biomet
  
• Sofamor Danek
  
• Interpore Cross International
  
• Norian Corporation
  
• Breast Implants
  
• The Market
  
• Factors That Influence The Market
  
• Devices
  
• Cochlear Implants
  
• The Market
  
• Growth Rate
  
• Critical Assumptions
  
• Factors That Influence The Market
  
• Devices
  
• Cochlear Corporation
  
• Medical Electronics (Med-El)
  
• Advanced Bionics Corporation
  
• Intraocular Lenses, Ocular Implants, And
  
• Artificial Eyes
  
• The Market
  
• Factors Influencing The Market
  
• Devices
  
• Integrated Orbital Implants, Inc
  
• Staar Surgical Company
  
• Dental Implants
  
• The Market
  
• Growth Rate
  
• Critical Assumptions
  
• Company Products
  

Technology

• The Challenge
  
• Safety
  
• Efficacy
  
• The Bioenginering Consortium (Becon)
  
• Other Funding Sources
  
• The National Center For Biotechnology Information
  
• (Ncbi)
  
• Biomaterials Compendium Database
  
• Bioengineering
  
• The Biocompatability Issue
  
• The Encapsulation Process
  
• When Encapsulation Is Not Desired
  
• Biomaterial-Centered Infection
  
• Materials Biocompatibility
  
• Biodegradable Polymers
  
• Hemocompatible Materials
  
• Typical Implant Materials
  
• Biocompatible Metal Alloys
  
• Biocompatible Ceramics
  
• Biocompatible Polymers And Implantable
  
• Devices
  
• Characterizing Polymers
  
• Additives
  
• Physical And Mechanical Properties
  
• Considerations When Choosing A Material
  
• Medical-Grade Polymers
  
• Coatings
  
• Biopolymers
  
• Biohybrid Materials
  
• "Smart" Biomaterials
  
• Tissue Engineering
  
• Tissue Repair, Regeneration And Maintenance
  
• Fda Working Groups
  
• Quality System Regulations
  
• Quality Control
  
• International Standards And Guidelines For
  
• Biological Testing Of Medical Devices
  
• Biocompatibility Testing
  
• Research Activities
  
• Artificial Heart, Valves, Blood Vessels And
  
• Blood
  
• Blood Substitutes
  
• Synthetic Bone, Cartilage And Other
  
• Connective Tissue Structures
  
• Drug-Delivery Devices
  
• Drug Seeding
  
• Ocular Drug Delivery
  
• Specific Developments
  
• Materials
  
• Technology
  
• Artificial Organs
  
• Nanotechnology
  
• Biodegradable Polymer Scaffolds
  
• Implantable Drug-Delivery Computer Chips
  
• Artificial Retina
  
• Process Economics
  
• Industry Leaders In Research And Development
  
• Patent Significance
  
• Significant Patents
  
• European Patents
  
• Manufacturing Flow Chart
  

International Aspects

• Export Markets For Medical Technology
  
• Biomedical Materials And Implant Device Export
  
• Markets
  
• Major Import Markets
  
• Pacemaker Parts
  
• Import Market For Artificial Joints, Parts And
  
• Accessories
  
• The International Marketplace
  
• Selling Products To Europe
  
• Requirements For Products Marketed In Europe
  
• Impact Of The Euro
  
• Selling Products To Japan
  
• Selling Products To Asia
  
• Selling Products To Latin America
  
• Emerging Market Opportunities
  
• India
  
• China
  
• Chinese Hospitals
  
• Competition In China
  
• Southeast Asia
  
• Major Overseas Raw Material And Biomaterial
  
• Companies And What They Do
  
• Effects Of Foreign Investment And Technology In
  
• The U.S.
  
• Effects Of U.S. Investment And Technology Overseas
  
• By Country/Region
  
• Corporate Identity
  
• Effect Of Fda Regulations On Foreign Investment
  
• U.S. And European Approaches To Product
  
• Performance
  
• U.S. Distributors For Export Markets
  

Industry Structure And Competitive Aspects

• Raw Materials
  
• Competitive Aspects Of The Industry
  
• Driving Forces Of The Biomedical Industry
  
• Competing Technologies
  
• Rate Of Technological Advancements
  
• What Future Success Depends On
  
• Important Strategies For Staying Competitive
  
• Technologies
  
• Balancing Innovation With Cost Containment
  
• Improving Or Retaining Quality Control
  
• Improving Time From R&D To Market
  
• Containing R&D And Manufacturing Costs
  
• Increasing Profits
  
• Trade Associations
  
• Health Industry Manufacturers Association
  
• (Hima)
  
• American Society Of Artificial Internal Organs
  
• (Asaio)
  
• Society For Biomaterials (Sb)
  
• Biotechnology Industry Organization (Bio)
  
• The American Institute For Medical And
  
• Biological Engineering (Aimbe)
  
• Acquisitions And Mergers
  
• Hospitals
  
• Rehabilitation Centers
  
• Evolution Stage In The Life Cycle
  
• Impact On/Of Other Industries
  
• Manufacturers Of Materials For Human
  
• Implantation
  
• Market Segmentation And Market Forces
  
• The Coronary Market
  
• The Orthopedic Market
  
• The Market For Other Implantable Devices
  
• Distribution Channels
  
• Domestic Distributors
  
• U.S. Distributors For Export Markets
  
• Internet Marketing
  
• Strategic Decision-Making
  
• Site-Selection Tools
  
• Industry Economics And Pricing
  
• The Domestic Market
  
• The International Market
  
• R&D Costs
  
• Product Liability
  
• Managed Care
  
• Medicare Reimbursement
  
• Pricing
  
• Trade Initiatives
  
• North American Fairtrade Agreement (Nafta)
  
• Asia-Pacific Economic Cooperation (Apec)
  
• Japan
  
• China
  
• Russia
  
• Purchasing Influences
  
• Buying Trends
  
• Material Costs
  

Company Profiles

• Profiles Of Implant Manufacturers
  
• American Companies
  
• Heart Implant Devices
  
• Medtronic, Inc.
  
• Guidant
  
• St. Jude Medical
  
• Baxter Healthcare Corporation
  
• Thermo Cardiosystems, Inc.
  
• Thoratec Laboratories
  
• Abiomed, Inc
  
• Orthopedic And Other Implant Device
  
• Manufacturers
  
• Biomet
  
• Depuy, Inc.
  
• Stryker Corporation
  
• Bionx Implants, Inc.
  
• Johnson&Johnson Medical, Inc
  
• Advanced Bionics Corporation
  
• Interpore Cross International
  
• Medical Electronics (Med-El)
  
• Norian Corporation
  
• Foreign Companies
  
• Sulzer Medica
  
• Cochlear Corporation
  
• Sofamor Danek Group (Medtronic)
  
• Other Implant Manufacturers
  
• Conmed Corporation
  
• Mentor Corporation
  
• Integrated Orbital Implants, Inc
  
• Staar Surgical Company
  

Appendix I

• American Implant Companies
  
• Foreign Implant Companies
  
• American Implant-Related Companies: Materials,
  
• Tissue Engineering, Drug Seeds And Others
  
• Foreign Implant-Related Companies: Materials,
  
• Tissue Engineering
  

Appendix II

• American Associations And Organizations
  
• Foreign Associations And Organizations
  

Appendix III

• Relevant American Standards Organizations
  
• Relevant Foreign And International Standards
  
• Organizations
  

Appendix IV

• Relevant U. S. Agencies And Groups
  

Appendix V

• Glossary Of Terms
  

Appendix VI

• Bibliography
  

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