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Medical Device Coatings

REPORT HIGHLIGHTS

The global medical device coating market reached about $6.1 billion in 2013. This market is expected to grow to $6.3 billion in 2014 and $9 billion in 2019, with a compound annual growth rate (CAGR) of 7.3% from 2014 to 2019.

This report provides:

  • An overview of the global markets for medical device coatings and related technologies.
  • Analyses of global market trends, with data from 2013, estimates for 2014, and projections of compound annual growth rates (CAGRs) through 2019.
  • Information on the specific drivers, trends, and challenges for different segments of the market.
  • Valuable insight into future trends, details on products, and information on coating manufacturers who supply the materials, the medical device companies which use it and the members of the healthcare that influence purchases.
  • Details pertaining to technologies including alloy, ceramic, combination, energy-absorbing, energy-emitting, micro and nano, protective polymer, and surface treatment.
  • Comprehensive profiles of major players in the industry.

SCOPE AND FORMAT

This study looks at medical device coatings and surface treatments from the perspective of both the supply and demand side of the equation that is from coating manufacturers that supply the materials, the medical device companies that use it and the members of the healthcare community who influence purchases.

Consistent with the scope of the study, the format of this report is arranged to present its five-year forecasts as a series of tables. Each of those tables presents U.S. current dollar demand values for coatings and surface processes for 2012 and 2013, and the five-year period from 2014 through 2019.

Separate sets of forecasts are presented for the:

  • Eight types of coatings and surface treatment technologies.
  • Nineteen healthcare areas that correspond to FDA medical device review panels.
  • United States, European Union, other developed nations and the rest of the world.

In addition to forecast tables, the report includes informational tables. These summarize FDA Freedom of Information act data about generic types of devices, their use within each healthcare area, and the regulatory pathway and burdens imposed upon them. Supplier detail includes the global distribution of production facilities, location and coating-related proprietary names. An appendix contains the abstract of major coating-related patents, including their initial assignees.

ANALYST'S CREDENTIALS

Technology analyst James Wilson prepared the original BCC Research study, HLC049A Medical Device Coating, and its revisions. He is the author of more than 300 articles and several books dealing with science, medicine, technology and business. Formerly the editor of the Princeton Business Journal and a senior science and technology editor for Hearst Magazines, he is a past member of the National Association of Science Writers and American Medical Writers Association. He has served on the adjunct faculty of Temple University and on the staffs of Drexel University and the Academy of Natural Sciences.

Table of Contents

CHAPTER 1 - INTRODUCTION

  • STUDY GOAL AND OBJECTIVES
  • REASONS FOR DOING THE STUDY
  • INTENDED AUDIENCE
  • SCOPE AND FORMAT
    • TECHNOLOGIES
    • HEALTHCARE AREAS
    • COUNTRIES AND REGIONS
      • TABLE A: EUROPEAN UNION
      • TABLE B: OTHER DEVELOPED NATIONS
      • TABLE C: REST OF THE WORLD
  • METHODOLOGY
  • INFORMATION SOURCES
  • ANALYST'S CREDENTIALS
  • RELATED BCC WORK CREDENTIALS
  • BCC RESEARCH WEBSITE
  • DISCLAIMER

CHAPTER 2 - SUMMARY

  • SUMMARY TABLE: GLOBAL MEDICAL DEVICE COATING MARKET BY REGION, THROUGH 2019 ($ MILLIONS)
  • SUMMARY FIGURE GLOBAL REQUIREMENT FOR MEDICAL DEVICE COATINGS BY REGION, 2012-2019 ($ MILLIONS)

CHAPTER 3 - INDUSTRY OVERVIEW

  • TABLE 1: THE 25 COMPANIES THAT DRIVE THE MEDICAL DEVICE BUSINESS, BY REVENUE, 2014 ($ BILLIONS)
  • HOW HEALTH DRIVES DEMAND FOR MEDICAL DEVICE COATINGS
    • TABLE 2: HOW ILLNESS AND ACCIDENT RATES CHANGE WITH AGE (NUMBER OF U.S. FATALITIES)
    • TABLE 3: MOST COMMON PATIENT SURGICAL PROCEDURES FOR OLDER AMERICANS
  • HOW COATINGS IMPROVE MEDICAL DEVICES
    • TABLE 4: LIFE-SUSTAINING MEDICAL DEVICES (BASED ON JULY 2014 FDA DATA)
    • TABLE 5: IMPLANTED MEDICAL DEVICES (BASED ON JULY 2014 FDA DATA)
    • TABLE 6: MEDICAL DEVICES NOTING COATINGS IN THEIR PROPRIETARY NAMES (BASED ON FDA DATA AS OF JULY 2014)
  • INDUSTRY-DRIVEN STANDARDIZATION
    • TABLE 7: FREQUENTLY CITED ISO MEDICAL DEVICE AND COATING RELATED STANDARDS
    • TABLE 8: FREQUENTLY CITED JOINT ANSI/AAMI/ISO MEDICAL DEVICE AND COATING RELATED STANDARDS
    • TABLE 9: AMERICAN SOCIETY FOR TESTING AND MATERIALS MEDICAL DEVICE AND COATING RELATED STANDARDS
  • GLOBAL HARMONIZATION
    • TABLE 10: MAJOR U.S. MEDICAL DEVICE MANUFACTURING FACILITIES (BASED ON FDA DATA AS OF JULY 2014)
    • TABLE 11: MAJOR MEDICAL DEVICE MANUFACTURING FACILITIES OUTSIDE OF THE U.S. (BASED ON FDA OWNER OPERATOR RECORDS AS OF JULY 2014)
  • STRATEGICALLY IMPORTANT TECHNICAL DEVELOPMENTS
    • SELF-POWERING MEDICAL DEVICES
    • MID-FIELD WIRELESS POWER TRANSMISSION
    • 3D-PRINTING
    • TRANSLATIONAL MEDICINE AND THE FUTURE R&D AGENDA
    • CORPORATE INVERSIONS

CHAPTER 4 - HOW THE FDA STRUCTURES THE GLOBAL MARKET

  • CONTROL CLASS IS THE CRITICAL REVIEW PARAMETER
    • TABLE 12: FDA REGULATORY CONTROLS
    • CLASS I MEDICAL DEVICES
    • CLASS II MEDICAL DEVICES
    • CLASS III MEDICAL DEVICES
  • REGULATORY PATHWAYS TO THE MARKETPLACE
  • FIGURE 1 510(K) "SUBSTANTIAL EQUIVALENCE" DECISION-MAKING PROCESS
  • FIGURE 2 TRENDS IN SUBSTANTIAL EQUIVALENT DECISIONS
  • FIGURE 3 TREND IN PMA APPROVALS
  • MEDICAL DEVICE AND COATING SUPPLIERS
    • CONTRACT MANUFACTURERS
    • CONTRACT STERILIZERS
    • DEVICE MANUFACTURERS
    • FOREIGN EXPORTERS
    • INITIAL DISTRIBUTORS OR IMPORTERS
    • RELABELERS
    • REMANUFACTURERS
    • REPACKAGERS
    • REPROCESSORS OF SINGLE-USE DEVICES
    • SPECIFICATIONS DEVELOPERS

CHAPTER 5 - COATINGS AND SURFACE TREATMENT TECHNOLOGIES

  • TABLE 13: DEMAND FOR ALL COATINGS AND TREATMENTS BY REGION, THROUGH 2019 ($ MILLIONS)
  • ALLOY COATINGS
    • TYPES OF ALLOY COATINGS
      • Aluminum
      • Copper
      • Gold
      • Nitinol
      • Silver Compounds
      • Stainless Steel
      • Titanium
      • Zinc Oxide
  • CERAMIC COATINGS DESCRIPTIONS AND FORECAST
    • TYPES OF CERAMIC COATINGS
      • Alumina
      • Bioglass
      • Carbon-Based
  • COMBINATION COATINGS DESCRIPTIONS AND FORECAST
    • TYPES OF COMBINATION COATINGS
      • Bone Morphogenetic Protein 2
      • Cationic Steroid Antimicrobials
      • Collagen
      • Dexamethasone
      • Gore/Carmeda BioActive Surface Technology
      • Heparin
      • Hyaluronan
      • Hydrogels
      • Hydroxyapatite
      • Medi-Coat Carrier Technology
      • Nitric Oxide
      • Paclitaxel
      • Parylenes
      • Phosphorylcholine (PC Technology)
      • Polymer Drugs
      • Polyethylene
      • Sirolimus, Everolimus and Zotarolimus
      • Stem Cell Coatings
  • ENERGY-ABSORBING COATINGS: DESCRIPTIONS
    • TYPES OF ENERGY-ABSORBING COATINGS
  • ENERGY-EMITTING COATINGS: DESCRIPTIONS
    • TYPES OF ENERGY-EMITTING COATINGS
      • Bioactive
      • Conductive
        • TABLE 14: CONDUCTIVE COATINGS FOR MEDICAL DEVICES
      • Galvanic
      • Radioactive
  • NANO-COATINGS
    • MICRO- AND NANO-MATERIALS
  • PROTECTIVE POLYMER COATINGS: DESCRIPTIONS
    • TABLE 15: LUBRICIOUS MEDICAL DEVICE COATINGS
  • TYPES OF PROTECTIVE POLYMER COATINGS
    • Hexyl-PVP
    • PDMS poly(dimethyl siloxane)
    • Polyurethane
    • Polytetrafluoroethylene Teflon
    • Polyvinyl Chloride
  • SURFACE TREATMENT DESCRIPTIONS
    • TYPES OF SURFACE TREATMENTS
      • Direct Deposition Techniques
      • Plasma Techniques
      • Ion Implantation Techniques
      • Laser Activation
      • Texturing
  • COATING FORECASTS
    • TABLE 16: U.S. DEMAND FOR MEDICAL DEVICE COATINGS BY MATERIAL, THROUGH 2019 ($ MILLIONS)
    • TABLE 17: EUROPEAN UNION DEMAND FOR MEDICAL DEVICE COATINGS BY MATERIAL, THROUGH 2019 ($ MILLIONS)
    • TABLE 18: OTHER DEVELOPED NATIONS DEMAND FOR MEDICAL DEVICE COATINGS BY MATERIAL, THROUGH 2019 ($ MILLIONS)
    • TABLE 19: REST OF THE WORLD DEMAND FOR MEDICAL DEVICE COATINGS BY MATERIAL, THROUGH 2019 ($ MILLIONS)
  • MEDICAL DEVICE COATINGS PATENT ANALYSIS
    • TABLE 20: THE 25 MOST RECENTLY ISSUED PATENTS REFERENCING MEDICAL DEVICES AND COATINGS, AS OF MARCH 3, 2012
  • REGIONAL DEMAND BY MATERIAL
    • TABLE 21: U.S. DEMAND FOR MEDICAL DEVICE COATINGS BY HEALTHCARE AREA AND MATERIAL, THROUGH 2019 ($ MILLIONS)
    • TABLE 22: EUROPEAN UNION DEMAND FOR MEDICAL DEVICE COATINGS BY HEALTHCARE AREA AND MATERIAL, THROUGH 2019 ($ MILLIONS)
    • TABLE 23: OTHER DEVELOPED NATIONS' DEMAND FOR MEDICAL DEVICE COATINGS BY HEALTHCARE AREA AND MATERIAL, THROUGH 2019 ($ MILLIONS)
    • TABLE 24: REST OF THE WORLD DEMAND FOR MEDICAL DEVICE COATINGS BY HEALTHCARE AREA AND MATERIAL, THROUGH 2019 ($ MILLIONS)

CHAPTER 6 - COATING DEMAND BY HEALTHCARE AREA

  • TABLE 25: MEDICAL DEVICE REVIEW PANELS
  • ANESTHESIOLOGY FORECAST AND DEVICES
    • TABLE 26: COATING FORECAST FOR ANESTHESIOLOGY DEVICES, THROUGH 2019 ($MILLIONS)
    • TABLE 27: ANESTHESIOLOGY DEVICES
  • CARDIOVASCULAR FORECAST AND DEVICES
    • TABLE 28: COATING FORECAST FOR CARDIOVASCULAR DEVICES, THROUGH 2019 ($ MILLIONS)
    • TABLE 29: CARDIOVASCULAR DEVICES
  • CLINICAL CHEMISTRY FORECAST AND DEVICES
    • TABLE 30: COATING FORECAST FOR CHEMISTRY DEVICES, THROUGH 2019 ($ MILLIONS)
    • TABLE 31: CHEMISTRY DEVICES
  • DENTAL DEVICES AND FORECAST
    • TABLE 32: COATING FORECAST FOR DENTAL DEVICES, THROUGH 2019 ($ MILLIONS)
    • TABLE 33: DENTAL DEVICES
  • EAR, NOSE AND THROAT FORECAST AND DEVICES
    • TABLE 34: COATING FORECAST FOR EAR, NOSE AND THROAT DEVICES, THROUGH 2019 ($ MILLIONS)
    • TABLE 35: EAR, NOSE AND THROAT DEVICES
  • GASTROENTEROLOGY AND UROLOGY DEVICES AND FORECAST
    • TABLE 36: COATING FORECAST FOR GASTROENTEROLOGY AND UROLOGY DEVICES, THROUGH 2019 ($ MILLIONS)
    • TABLE 37: GASTROENTEROLOGY AND UROLOGY DEVICES
  • GENERAL AND PLASTIC SURGERY FORECAST AND DEVICES
    • TABLE 38: COATING FORECAST FOR GENERAL AND PLASTIC SURGERY DEVICES, THROUGH 2019 ($MILLIONS)
    • TABLE 39: GENERAL AND PLASTIC SURGERY DEVICES
  • GENERAL HOSPITAL USE FORECAST AND DEVICES
    • TABLE 40: AVERAGE LENGTH OF HOSPITAL STAY BY SEX AND AGE (DAYS)
    • TABLE 41: COATING FORECAST FOR GENERAL HOSPITAL USE DEVICES, THROUGH 2019 ($MILLIONS)
    • TABLE 42: GENERAL HOSPITAL USE DEVICES
  • HEMATOLOGY FORECAST AND DEVICES
    • TABLE 43: COATING FORECAST FOR HEMATOLOGY DEVICES, THROUGH 2019 ($MILLIONS)
    • TABLE 44: HEMATOLOGY DEVICES
  • IMMUNOLOGY FORECAST AND DEVICES
    • TABLE 45: COATING FORECAST FOR IMMUNOLOGY DEVICES, THROUGH 2019 ($MILLIONS)
    • TABLE 46: IMMUNOLOGY DEVICES
  • MICROBIOLOGY FORECAST AND DEVICES
    • TABLE 47: COATING FORECAST FOR MICROBIOLOGY DEVICES, THROUGH 2019 ($ MILLIONS)
    • TABLE 48: MICROBIOLOGY DEVICES
  • NEUROLOGY DEVICES AND FORECAST
    • TABLE 49: COATING FORECAST FOR NEUROLOGY DEVICES, THROUGH 2019 ($ MILLIONS)
    • TABLE 50: NEUROLOGY DEVICES
  • OBSTETRICS AND GYNECOLOGY FORECAST AND DEVICES
    • TABLE 51: COATING FORECAST FOR OBSTETRICS AND GYNECOLOGY DEVICES, THROUGH 2019 ($MILLIONS)
    • TABLE 52: OBSTETRICS AND GYNECOLOGY DEVICES
  • OPHTHALMOLOGY FORECAST AND DEVICES
    • TABLE 53: COATING FORECAST FOR OPHTHALMOLOGY DEVICES, THROUGH 2019 ($ MILLIONS)
    • TABLE 54: OPHTHALMOLOGY DEVICES
  • ORTHOPEDIC DEVICE AND FORECAST
    • TABLE 55: COATING FORECAST FOR ORTHOPEDIC DEVICES, THROUGH 2019 ($MILLIONS)
    • TABLE 56: ORTHOPEDIC DEVICES
  • PATHOLOGY FORECAST
    • TABLE 57: COATING FORECAST FOR PATHOLOGY DEVICES, THROUGH 2019 ($MILLIONS)
    • TABLE 58: PATHOLOGY DEVICES
  • PHYSICAL MEDICINE FORECAST AND DEVICES
    • TABLE 59: COATING FORECAST FOR PHYSICAL MEDICINE DEVICES, THROUGH 2019 ($MILLIONS)
    • TABLE 60: PHYSICAL MEDICINE DEVICES
  • RADIOLOGY DEVICES AND FORECAST
    • TABLE 61: COATING FORECAST FOR RADIOLOGY DEVICES, THROUGH 2019 ($MILLIONS)
    • TABLE 62: RADIOLOGY DEVICES
  • TOXICOLOGY FORECAST AND DEVICES
    • TABLE 63: COATING FORECAST FOR TOXICOLOGY DEVICES, THROUGH 2019 ($MILLIONS)
    • TABLE 64: TOXICOLOGY DEVICES

CHAPTER 7 - APPENDIX

  • SIGNIFICANT COATING PATENTS

LIST OF TABLES

  • TABLE A: EUROPEAN UNION
  • TABLE B: OTHER DEVELOPED NATIONS
  • TABLE C: REST OF THE WORLD
  • SUMMARY TABLE: GLOBAL MEDICAL DEVICE COATING MARKET BY REGION, THROUGH 2019 ($ MILLIONS)
    • TABLE 1: THE 25 COMPANIES THAT DRIVE THE MEDICAL DEVICE BUSINESS, BY REVENUE, 2014 ($ BILLIONS)
    • TABLE 2: HOW ILLNESS AND ACCIDENT RATES CHANGE WITH AGE (NUMBER OF U.S. FATALITIES)
    • TABLE 3: MOST COMMON PATIENT SURGICAL PROCEDURES FOR OLDER AMERICANS
    • TABLE 4: LIFE-SUSTAINING MEDICAL DEVICES (BASED ON JULY 2014 FDA DATA)
    • TABLE 5: IMPLANTED MEDICAL DEVICES (BASED ON JULY 2014 FDA DATA)
    • TABLE 6: MEDICAL DEVICES NOTING COATINGS IN THEIR PROPRIETARY NAMES (BASED ON FDA DATA AS OF JULY 2014)
    • TABLE 7: FREQUENTLY CITED ISO MEDICAL DEVICE AND COATING RELATED STANDARDS
    • TABLE 8: FREQUENTLY CITED JOINT ANSI/AAMI/ISO MEDICAL DEVICE AND COATING RELATED STANDARDS
    • TABLE 9: AMERICAN SOCIETY FOR TESTING AND MATERIALS MEDICAL DEVICE AND COATING RELATED STANDARDS
    • TABLE 10: MAJOR U.S. MEDICAL DEVICE MANUFACTURING FACILITIES (BASED ON FDA DATA AS OF JULY 2014)
    • TABLE 11: MAJOR MEDICAL DEVICE MANUFACTURING FACILITIES OUTSIDE OF THE U.S. (BASED ON FDA OWNER OPERATOR RECORDS AS OF JULY 2014)
    • TABLE 12: FDA REGULATORY CONTROLS
    • TABLE 13: DEMAND FOR ALL COATINGS AND TREATMENTS BY REGION, THROUGH 2019 ($ MILLIONS)
    • TABLE 14: CONDUCTIVE COATINGS FOR MEDICAL DEVICES
    • TABLE 15: LUBRICIOUS MEDICAL DEVICE COATINGS
    • TABLE 16: U.S. DEMAND FOR MEDICAL DEVICE COATINGS BY MATERIAL, THROUGH 2019 ($ MILLIONS)
    • TABLE 17: EUROPEAN UNION DEMAND FOR MEDICAL DEVICE COATINGS BY MATERIAL, THROUGH 2019 ($ MILLIONS)
    • TABLE 18: OTHER DEVELOPED NATIONS DEMAND FOR MEDICAL DEVICE COATINGS BY MATERIAL, THROUGH 2019 ($ MILLIONS)
    • TABLE 19: REST OF THE WORLD DEMAND FOR MEDICAL DEVICE COATINGS BY MATERIAL, THROUGH 2019 ($ MILLIONS)
    • TABLE 20: THE 25 MOST RECENTLY ISSUED PATENTS REFERENCING MEDICAL DEVICES AND COATINGS, AS OF MARCH 3, 2012
    • TABLE 21: U.S. DEMAND FOR MEDICAL DEVICE COATINGS BY HEALTHCARE AREA AND MATERIAL, THROUGH 2019 ($ MILLIONS)
    • TABLE 22: EUROPEAN UNION DEMAND FOR MEDICAL DEVICE COATINGS BY HEALTHCARE AREA AND MATERIAL, THROUGH 2019 ($ MILLIONS)
    • TABLE 23: OTHER DEVELOPED NATIONS' DEMAND FOR MEDICAL DEVICE COATINGS BY HEALTHCARE AREA AND MATERIAL, THROUGH 2019 ($ MILLIONS)
    • TABLE 24: REST OF THE WORLD DEMAND FOR MEDICAL DEVICE COATINGS BY HEALTHCARE AREA AND MATERIAL, THROUGH 2019 ($ MILLIONS)
    • TABLE 25: MEDICAL DEVICE REVIEW PANELS
    • TABLE 26: COATING FORECAST FOR ANESTHESIOLOGY DEVICES, THROUGH 2019 ($MILLIONS)
    • TABLE 27: ANESTHESIOLOGY DEVICES
    • TABLE 28: COATING FORECAST FOR CARDIOVASCULAR DEVICES, THROUGH 2019 ($ MILLIONS)
    • TABLE 29: CARDIOVASCULAR DEVICES
    • TABLE 30: COATING FORECAST FOR CHEMISTRY DEVICES, THROUGH 2019 ($ MILLIONS)
    • TABLE 31: CHEMISTRY DEVICES
    • TABLE 32: COATING FORECAST FOR DENTAL DEVICES, THROUGH 2019 ($ MILLIONS)
    • TABLE 33: DENTAL DEVICES
    • TABLE 34: COATING FORECAST FOR EAR, NOSE AND THROAT DEVICES, THROUGH 2019 ($ MILLIONS)
    • TABLE 35: EAR, NOSE AND THROAT DEVICES
    • TABLE 36: COATING FORECAST FOR GASTROENTEROLOGY AND UROLOGY DEVICES, THROUGH 2019 ($ MILLIONS)
    • TABLE 37: GASTROENTEROLOGY AND UROLOGY DEVICES
    • TABLE 38: COATING FORECAST FOR GENERAL AND PLASTIC SURGERY DEVICES, THROUGH 2019 ($MILLIONS)
    • TABLE 39: GENERAL AND PLASTIC SURGERY DEVICES
    • TABLE 40: AVERAGE LENGTH OF HOSPITAL STAY BY SEX AND AGE (DAYS)
    • TABLE 41: COATING FORECAST FOR GENERAL HOSPITAL USE DEVICES, THROUGH 2019 ($MILLIONS)
    • TABLE 42: GENERAL HOSPITAL USE DEVICES
    • TABLE 43: COATING FORECAST FOR HEMATOLOGY DEVICES, THROUGH 2019 ($MILLIONS)
    • TABLE 44: HEMATOLOGY DEVICES
    • TABLE 45: COATING FORECAST FOR IMMUNOLOGY DEVICES, THROUGH 2019 ($MILLIONS)
    • TABLE 46: IMMUNOLOGY DEVICES
    • TABLE 47: COATING FORECAST FOR MICROBIOLOGY DEVICES, THROUGH 2019 ($ MILLIONS)
    • TABLE 48: MICROBIOLOGY DEVICES
    • TABLE 49: COATING FORECAST FOR NEUROLOGY DEVICES, THROUGH 2019 ($ MILLIONS)
    • TABLE 50: NEUROLOGY DEVICES
    • TABLE 51: COATING FORECAST FOR OBSTETRICS AND GYNECOLOGY DEVICES, THROUGH 2019 ($MILLIONS)
    • TABLE 52: OBSTETRICS AND GYNECOLOGY DEVICES
    • TABLE 53: COATING FORECAST FOR OPHTHALMOLOGY DEVICES, THROUGH 2019 ($ MILLIONS)
    • TABLE 54: OPHTHALMOLOGY DEVICES
    • TABLE 55: COATING FORECAST FOR ORTHOPEDIC DEVICES, THROUGH 2019 ($MILLIONS)
    • TABLE 56: ORTHOPEDIC DEVICES
    • TABLE 57: COATING FORECAST FOR PATHOLOGY DEVICES, THROUGH 2019 ($MILLIONS)
    • TABLE 58: PATHOLOGY DEVICES
    • TABLE 59: COATING FORECAST FOR PHYSICAL MEDICINE DEVICES, THROUGH 2019 ($MILLIONS)
    • TABLE 60: PHYSICAL MEDICINE DEVICES
    • TABLE 61: COATING FORECAST FOR RADIOLOGY DEVICES, THROUGH 2019 ($MILLIONS)
    • TABLE 62: RADIOLOGY DEVICES
    • TABLE 63: COATING FORECAST FOR TOXICOLOGY DEVICES, THROUGH 2019 ($MILLIONS)
    • TABLE 64: TOXICOLOGY DEVICES

LIST OF FIGURES

  • SUMMARY FIGURE: GLOBAL REQUIREMENT FOR MEDICAL DEVICE COATINGS BY REGION, 2012-2019 ($ MILLIONS)
    • FIGURE 1: 510(K) "SUBSTANTIAL EQUIVALENCE" DECISION-MAKING PROCESS
    • FIGURE 2: TRENDS IN SUBSTANTIAL EQUIVALENT DECISIONS
    • FIGURE 3: TREND IN PMA APPROVALS
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