Medical Device Coatings

Summary

INTRODUCTION

STUDY GOALS AND OBJECTIVES

This study examines the most rapidly changing sector of the global medical device business. It describes technological and regulatory developments that have influenced the direction of this dynamic industry and also forecasts the global and regional requirements for coating and kindred treatment technologies through 2014.

REASON FOR DOING THE STUDY

In 2006, BCC Research published Medical Device Coatings (HLC049A), a comprehensive study that quantified the extent to which coating materials were being used to improve the functionality, longevity, and cost-effectiveness of medical devices. At that time, BCC noted several key trends. Chief among these was the rapid acceptance of drug-eluting coatings by the medical community, which had spurred interest in the technology on the part of both coating suppliers and device makers. Responding to the new technology, the regulatory community began to proactively adapt itself to encourage the development of coated devices. In the U.S., the Food and Drug Administration (FDA) had created a new office to focus on combination products (e.g., coated stents) that had crossed the regulatory boundaries between drugs and devices.

The earlier BCC study also noted the emergence of pure-play medical device-coating enterprises, several of which were the outgrowth of university-based commercialization programs. Finally it predicted that the future path of development would be typical of many new technologies in that it would be strewn with unanticipated difficulties that would emerge only as products moved off the lab bench and into the commercial pipeline.

Since that 2006 study, the medical device coatings industry has developed more or less along the path that most had anticipated. There have also been reversals, including highly visible product recalls. Not surprisingly, bureaucratic realities have dampened initial optimism regarding swift product approvals. Blue sky projections for rapid growth have been clouded by unanticipated patent litigation, and in the case of start-ups, competition from larger and more financially robust companies has created obstacles. A dearth of financial assistance for initial public offerings has further contributed to dampening enthusiasm. Nonetheless, the secular trends driving the industry remain strong. As the Baby Boom generation ages, the medical outcome advantages of coated implants become more evident, and the spirit of innovation continues to infuse the industry with fresh ideas and institutional support from universities and government funding agencies.

The net effect has been that the medical device coating industry has been growing at less than the predicted 12.4% compound annual growth rate (CAGR), although still at an impressive rate. In this study, which covers the period from 2009 through 2014, BCC forecasts a 9.9% CAGR as this promising industry matures into an essential sector of the world economy.

INTENDED AUDIENCE

This study will be of interest to the medical device industry; the coating industry; suppliers of alloys, ceramics, polymers, and other materials used in the manufacturing of coatings; manufacturers of chemicals, pharmaceuticals, and energy sources that can be incorporated into coatings; coating and medical device importers; and medical device contract manufacturers. It will also provide useful insights for those exploring investments in this vibrant and growing segment of the medical device industry.

SCOPE OF REPORT

The scope of this study is the same as our 2006 investigation of the industry. It looks at medical device coatings industry from the perspective of the coating producer, the manufacturer, and the end-user. This study differs in the way the data have been organized. In the previous report, regional demand was divided on the basis of national income with the U.S. separated as a distinct market. Since then, the medical device coatings industry has begun to divide itself along regional patterns that follow similarities in regulatory behavior.

As a result, this report adopts a regional division consisting of the North American Free Trade Agreement (NAFTA) countries, the European Union (E.U.), Other Developed Countries outside of those two major trade locks, and the Rest of the World. Coating technologies are separated on the basis of their underlying chemistry and physics, resulting in eight categories. Finally, the demand in terms of devices used in the 22 areas of medical specialty is examined. The result is a report containing nearly 150 tables, 55 of which provide U.S. dollar-value requirement coatings for 2005, 2008, 2009, and 2014.

We present requirement forecasts by type of technology, by regions of the world in which the devices are used, and by medical specialty. To this end we distinguish among:

• Eight technologies
• Four regions of the world
• Twenty-two medical specialties

The eight technologies, which comprise seven classes of coatings, are grouped on the basis of their most noteworthy chemical or characteristic and all treatment processes that do not use coating materials. For example, chrome plating is considered an alloy. Surface texturing, regardless of whether it is the product of acid etching or laser vaporization, is considered a surface treatment.

The technology groups are:

• Alloy
• Ceramic
• Combination
• Energy-absorbing and optical
• Energy-emitting
• Micro and nano
• Protective polymer
• Surface treatment

The four regions in which devices are used are:

• 1. North American Free Trade Agreement (NAFTA) countries, (i.e., Canada, Mexico, and the U.S., including Puerto Rico)
• 2. European Union (E.U.) (i.e., the 27 member countries as of September 2008)
• 3. Other Developed Nations (i.e., the 39 countries that BCC considers to have economies and medical device regulations comparable to those of NAFTA and E.U. countries.
• 4. Rest of the World

TWENTY-TWO MEDICAL SPECIALITIES

The BCC listing expands upon the FDA medical specialties grouping by separating several areas that are combined by the FDA. For example, the FDA treats gastroenterology and urology as one group for the purpose of device review. In the table entitled Medical Devices By Type and Variation, BCC follows the FDA practice of using combined areas in reporting the number of types of devices (i.e., 4,432) and device variations (i.e., 106,768), but the study provides separate dollar-value forecasts for gastroenterology and urology products. Similarly, many devices used in hospital settings are also used by outpatients. The FDA combines hospital and personal use products for device review purposes. Here, BCC also provides separate forecasts. Some products have significant use in several medical specialties. In those cases, the study includes those devices in the listings for that specialty. Forecasted values proportionately reflect use in that medical specialty. Forecasts are therefore provided for the following 22 medical specialties.enty-two Medical Specialties

• Anesthesia
• Cardiovascular
• Clinical medicine
• Clinical toxicology
• Dental
• Ear, nose, and throat
• Gastroenterology
• General hospital
• General surgery
• Hematology
• Immunology
• Microbiology
• Neurology
• Obstetrics and gynecology
• Ophthalmology
• Orthopedics
• Pathology
• Personal use
• Physical medicine
• Radiology
• Respiratory therapy
• Urology

The country groupings have also been changed. In BCCs 2006 study, regions were grouped in a manner that reflected World Bank income levels. Since then, considerable efforts have been undertaken to consolidate and harmonize device regulation among the two major trade blocks-the North American Free Trade Agreement (NAFTA) nations and the European Union (E.U.) nations. As a result, trade in medical devices is now more strongly driven by regulatory than gross economic conditions. Reflecting that reality, this study reports the U.S. as part of NAFTA and identifies the E.U. as a separate region.

The study also includes more precise forecasts for medical specialties. In BCCs earlier report, only values for those medical specialties that were expected to make significant use of coatings within the original forecast period, which concluded in 2010, were reported. Since then, coatings have come into general use in 22 medical and healthcare specialties for which comprehensive FDA data is available. Hence, in this report, BCC is able to provide separate use by coating technology and use by region forecasts for all 22 areas.

Finally, to harmonize the present work with the 2006 study, BCC has included a column showing 2005 forecast values as redistributed to reflect the previously described NAFTA/E.U. regional reporting format. The redistributed data for 2005 presented in this report is also more accurate than that available when the 2006 report went to press. Consequently, the value for coatings at the producer price level has been adjusted downward by $16 million (i.e., from $2,960 million in the 2006 report to $2,944 million).

A special note to purchasers of the 2006 study:The mostobvious change is that BCC now presents forecast values at the million-dollar rather than billion-dollar level.

METHODOLOGY

The FDA recognizes more than 106,000 different types of medical devices distributed among nearly 4,400 general types of products. In this study, BCC focuses on the subset of those products that are currently benefiting or will soon benefit from the addition of coatings (e.g., drug-eluting polymers) or surface treatments (e.g., texturing) to improve performance or enhance patient safety.

In this study, BCC reports values at the producer price level, shown to the nearest $1 million. Values are in current U.S. dollars and are not adjusted to compensate for inflation.

INFORMATION SOURCES

BCC Research studied approximately 250 companies to obtain data for this study, including coating manufacturers, medical device manufacturers, and pharmaceutical companies. Also reviewed were reports and studies prepared by the FDA and comparable foreign regulatory agencies; organizations representing physicians, surgeons, hospital administrators, and trade and professional associations; foreign government trade associations; and insurers. In addition, data were compiled from the FDA medical device data registry, the U.S. Security and Exchange Commission corporate filings database, and the U.S. Patent and Trademark office.

Contents

Chapter One: Introduction

Study Goal and Objectives
Reasons for Doing The Study
Intended Audience
Scope of Report
Twenty-Two Medical Specialties
Methodology

Chapter Two: Summary

Summary Table Global Medical Device Coating Market,by Region, through 2014 ($ Millions)
Summary Figure Global Medical Device Coating Market,by Region, 2009 and 2014 ($ Millions)

Chapter Three: Industry Overview

Industry Overview
The Evolving Medical Device Coating Industry
International Cooperation and Harmonization
International Standardization Organization
Table 1 Iso 10993 Standards Pertaining to Medical Device Coatings
American Society for Testing and Materials
Table 2 Proposed Standards under Consideration by Astm International Committee on Medical and Surgical Materials and Devices
Table 3 Astm Coating-Related Standards

Chapter Four: The Medical Device Coatings Community

Nationally Based Organizations
The Continuing Importance of Academic Research
Coating Purchasers and Buying Influences
Contract Manufacturers
Contract Sterilizers
Device Manufacturers
Foreign Exporters
Initial Distributors
Relabelers
Remanufacturers
Repackagers
Reprocessors of Single-Use Devices
Specification Developers
Coating Suppliers

Chapter Five: The Fda and The Coating Industry

The Fda and The Coating Industry
Control Class Designation
Class I Medical Devices
Class Ii Medical Devices
Class Iii Medical Devices
Coatings Lead to A New Product Category
Fda Panel Assignments Segment The Market
Table 4 Medical Devices, by Type and Variation Coating-Related Recalls
Table 5 Fda Recalls Involving Coatings

Chapter Six: Patent Analysis

Table 6 Medical Device Coating Patents Issued since 1976
Table 7 Key Drug-Related Coating Patents
Table 8 Heparin-Related Coating Patents
Table 9 Stent-Related Coating Patents

Chapter Seven: Factors Driving Coating Demand

Boomers Reach Medicare Age
Boomers Reach Medicare Age (Continued)
Table 10 Global Growth in Older Populations (% of Population Age 65 or Older in 2015)
Table 11 Most Common Inpatient Surgical Procedures for Older Americans
Table 12 Average Length of Hospital Stay by Sex and Age (Days)
The Medicare Nosocomial Infection Initiative
Uncertain Impact of Medical Tourism on Coatings

Chapter Eight: Assessing Coating Requirements

Assessing Coating Requirements
Table 13 Three Perspectives on The Coatings Market
Regional Definitions
Table 14 Global Requirement for Medical Device Coatings Used in All Medical Specialties, by Region, through 2014 ($ Millions)
Figure 1 Global Requirement for Medical Device Coatings Used in All Medical Specialties, by Region, through 2014 ($ Millions)
North American Free Trade Agreement Countries
Table 15 Nafta Countries
European Union
Table 16 European Union Countries
Other Developed Nations
Table 17 Other Developed Countries
Rest of The World
Table 18 Rest of The World

Chapter Nine: 2009 to 2014 Requirement Forecasts byCoating Technology

Table 19 Requirement for Medical Device Coatings, by Technology, through 2014 ($ Millions)
Figure 2 Global Requirement for Coating Materials, 2014 ($ Millions)
Table 20 Requirement for All Coating Technologies, by All Medical Specialties, through 2014 ($ Millions)
Alloy Coating Technologies
Aluminum
Gold
Nitinol
Silver Compounds
Stainless Steel
Titanium
Zinc Oxide
Global Requirement Forecast for Alloy Technologies
Table 21 Requirement for Alloy Coating Technology, by Medical Specialty, through 2014 ($ Millions)
Ceramic Coating Technologies
Alumina
Bioglass
Carbon-Based
Global Requirement Forecast for Ceramic-Based
Technologies
Table 22 Requirement for Ceramic Technology
Coatings, by Medical Specialty, through 2014($ Millions)
Combination Product Coating Technologies
Table 23 Active Agents and Carriers Used in Combination Product Coatings
Medi-Coat Carrier Technology
Bone Morphogenetic Protein 2
Cationic Steroid Antimicrobials
Collagen
Dexamethasone
Gore/Carmeda Bioactive Surface Technology
Heparin
Hyaluronan
Hydrogels
Hydroxyapatite
Nitric Oxide
Paclitaxel
Parylenes (Poly-Para-Xylene)
Phosphorylcholine (PC Technology)
Polymerdrugs
Polyethylene
Polyethylene (Continued)
Sirolimus, Everolimus, and Zotarolimus
Stem Cell Coatings
Global Requirement Forecast for Combination Product Technologies
Table 24 Requirement for Combination Product Technologies, by Medical Specialty, through 2014($ Millions) Energy-Absorbing Technologies
Global Requirement Forecast for Energy-Absorbing Coating Technologies
Table 25 Requirement for Energy-Absorbing Technology Coatings, by Medical Specialty, through 2014 ($ Millions)
Energy-Emitting Technologies
Global Requirement Forecast for Energy-Emitting Technologies
Table 26 Requirement for Energy-Emitting Technologies, by Medical Specialty, through 2014($ Millions)
Micro- and Nano-Coatings Continuing Uncertainty on Health Risks
Global Requirement Forecast for Micro and Nano Technologies
Table 27 Requirement for Micro- and Nanotechnology Coatings, by Medical Specialty, through 2014($ Millions)
Protective Polymer Coatings
Hexyl-Pvp
Pdms Poly(Dimethyl Siloxane)
Polyurethane
Ptfe Polytetrafluoroethylene Teflon
Pvc Polyvinyl Chloride
Global Requirement Forecast for Protective
Polymer Technologies
Table 28 Requirement for Protective Polymer Technologies, by Medical Specialty, through 2014($ Millions)
Surface Treatment Technologies
Direct Deposition Techniques
Plasma Techniques
Ion Implantation Techniques
Laser Activation
Texturing
Global Requirement Forecast for Surface Treatment Technologies
Table 29 Global Requirement for Surface Treatment Technologies, by Medical Specialty, through 2014($ Millions)

Chapter Ten: 2009 to 2014 Requirement Forecasts by Medical Specialty

Table 30 Factors Influencing The Requirement for New Coatings Anesthesia Device Coating Requirements
Table 31 Anesthesia Diagnostic Devices
Table 32 Anesthesia Monitoring Devices
Table 33 Therapeutic Anesthesia Devices
Table 34 Miscellaneous Anesthesia Devices
Technology Requirement for Anesthesia Device Coatings
Table 35 Global Coating Requirements for AnesthesiaDevices, by Technology, through 2014 ($ Millions)
Regional Requirement for Anesthesia Device Coatings
Table 36 Regional Coating Requirements for Anesthesia Devices ($ Millions)
Cardiovascular Medicine
Table 37 Cardiovascular Diagnostic Devices
Table 38 Cardiovascular Monitoring Devices
Table 39 Cardiovascular Prosthetic Devices
Table 40 Cardiovascular Surgical Devices
Table 41 Cardiovascular Therapeutic Devices Technology Requirement for Cardiovascular Device Coatings
Table 42 Global Coating Requirements for Cardiovascular Devices, by Technology, through 2014($ Millions)
Regional Requirement for Cardiovascular Device Coatings
Table 43 Regional Coating Requirements for Cardiovascular Devices, through 2014 ($ Millions)
Clinical Medicine
Table 44 Clinical Chemistry Test Systems
Table 45 Clinical Laboratory Instruments Technology Requirements for Clinical
Chemistry Device Coatings
Table 46 Global Coating Requirements for Clinical Medicine Devices, by Technology, through 2014($ Millions)
Regional Requirement for Clinical Medicine
Device Coatings
Table 47 Regional Coating Requirements for Clinical Medicine Devices, through 2014 ($ Millions)
Clinical Toxicology
Table 48 Clinical Toxicology Test Systems
Technology Requirements for Clinical Toxicology Device Coatings
Table 49 Global Coating Requirements for Clinical Toxicology Devices, by Technology, through 2014($ Millions)
Regional Requirements for Clinical Toxicology
Device Coatings
Table 50 Regional Coating Requirements for Clinical Toxicology Devices, through 2014 ($ Millions)
Dentistry
Table 51 Dental Diagnostic Devices
Table 52 Dental Prosthetic Devices
Table 53 Dental Surgical Devices
Table 54 Dental Therapeutic Devices
Table 55 Miscellaneous Dental Devices
Technology Requirement for Dental Device Coatings
Table 56 Global Coating Requirement for DentalDevices, by Technology, through 2014 ($ Millions)
Regional Requirement for Dental Device Coatings
Table 57 Regional Coating Requirements for DentalDevices, through 2014 ($ Millions) Ear, Nose, and Throat
Table 58 Ear, Nose, and Throat Diagnostic Devices
Table 59 Ear, Nose, and Throat Prosthetic Devices
Table 60 Ear, Nose, and Throat Surgical Devices
Table 61 Ear, Nose, and Throat Therapeutic Devices Technical Requirements for Coatings for Medical Devices Used by Ear, Nose, and Throat Specialists
Table 62 Global Coating Requirement for Ear, Nose, and Throat Devices, by Technology, through 2014($ Millions)
Regional Requirements for Coatings for Medical Devices Used by Ear, Nose, and Throat Specialists
Table 63 Global Coating Requirement for Ear, Nose, and Throat Devices, by Region, through 2014 ($ Millions)
Gastroenterology
Table 64 Gastroenterology Diagnostic Devices
Table 65 Gastroenterology-Urology Surgical Devices
Table 66 Gastroenterology-Urology Therapeutic Devices Technology Requirements for Coatings for Gastroenteric Devices
Table 67 Global Coating Requirement for Gastroenterology Devices, by Technology, through
2014 ($ Millions)
Regional Requirements for Coatings for Gastroenteric Devices
Table 68 Regional Coating Requirement for Gastroenterology Devices, through 2014 ($ Millions) General and Plastic Surgery
Table 69 Surgical Devices
Technology Requirements for Surgical Device
Coatings
Table 70 Global Coating Requirement for General and Plastic Surgery Devices, by Technology, through 2014($ Millions)
Regional Requirements for Surgical Device Coatings
Table 71 Regional Coating Requirement for General and Plastic Surgery Devices, through 2014 ($ Millions)
General Hospital Use Devices
Table 72 Monitoring Devices for General Hospital Use
Table 73 Therapeutic Devices for General Hospital Use
Table 74 Miscellaneous Medical Devices for General

Hospital Use
Technology Requirements for General Hospital
Medical Device Coatings
Table 75 Global Coating Requirements for General Hospital Devices, by Technology, through 2014($ Millions)
Regional Requirements for General Hospital Medical Device Coatings
Table 76 Regional Coating Requirements for General Hospital Devices, through 2014 ($ Millions)
Hematology
Table 77 Hematology Instrumentation
Table 78 Automated and Semi-Automated HematologyDevices
Table 79 Manual Hematology Devices
Table 80 Blood Bank Supplies
Technology Requirements for Coatings for Hematology Devices
Table 81 Global Coating Requirements for HematologyDevices, by Technology, through 2014 ($ Millions)
Regional Requirements for Coatings for Hematology Devices
Table 82 Regional Coating Requirements for Hematology Devices, through 2014 ($ Millions) Immunology
Table 83 Immunology Laboratory Equipment and Reagents
Table 84 Tumor Associated Antigen Immunological Test Systems
Technology Requirements for Coatings for Immunological Devices
Table 85 Global Coating Requirement for ImmunologyDevices, by Technology, through 2014 ($ Millions)
Regional Requirement for Coatings for
Immunological Devices
Table 86 Regional Coating Requirement for Immunology Devices, through 2014 ($ Millions)
Microbiology
Table 87 Devices Used in Microbiology Devices Technology Requirements for Microbiology

Device Coatings
Table 88 Global Coating Requirement for Devices Used in Microbiology, through 2014 ($ Millions)
Technology Requirements for Microbiology Device Coatings
Table 89 Regional Coating Requirements for Devices Used in Microbiology, through 2014 ($ Millions)
Neurology
Table 90 Neurological Diagnostic Devices
Table 91 Neurological Surgical Devices
Table 92 Neurological Therapeutic Devices
Technology Requirements for Neurological Device Coatings
Table 93 Global Coating Requirements for NeurologyDevices, by Technology, through 2014 ($ Millions)
Regional Technology Requirement for Neurological Device Coatings
Table 94 Regional Coating Requirements for NeurologyDevices, through 2014 ($ Millions)
Obstetrics and Gynecology
Table 95 Obstetrical and Gynecological DiagnosticDevices
Table 96 Obstetrical and Gynecological MonitoringDevices
Table 97 Obstetrical and Gynecological ProstheticDevices
Table 98 Obstetrical and Gynecological SurgicalDevices
Table 99 Obstetrical and Gynecological TherapeuticDevices
Table 100 Assisted Reproduction Devices
Technology Requirements for Obstetrical and
Gynecological Device Coatings
Table 101 Coating Requirement for Obstetrics and Gynecology Devices, by Technology, through 2014($ Millions)
Regional Requirements for Obstetrical and Gynecological Device Coatings
Table 102 Regional Coating Requirement for Obstetrics and Gynecology Devices, through 2014 ($ Millions)
Ophthalmology
Table 103 Ophthalmic Diagnostic Devices
Table 104 Ophthalmic Prosthetic Devices
Table 105 Ophthalmic Surgical Devices
Table 106 Ophthalmic Therapeutic Devices
Technology Requirements for Ophthalmic Device Coatings
Table 107 Global Coating Requirement for
Ophthalmology, by Technology, through 2014($ Millions)
Region Technology Requirements for
Ophthalmic Device Coatings
Table 108 Regional Coating Requirements for Ophthalmology Devices, through 2014 ($ Millions)
Orthopedics
Table 109 Orthopedic Diagnostic Devices
Table 110 Orthopedic Prosthetic Devices
Table 111 Orthopedic Surgical Devices
Technology Requirements for Orthopedic Device Coatings
Table 112 Global Coating Requirements for Orthopedics Devices, by Technology, through 2014($ Millions)
Regional Requirements for Orthopedic Device Coatings
Table 113 Regional Coating Requirements for Orthopedics Devices, through 2014 ($ Millions) Pathology
Table 114 Pathology Instrumentation
Table 115 Automated and Semi-Automated PathologyDevices
Table 116 Manual Pathology Devices
Technology Requirements for Pathology
Device Coatings
Table 117 Global Coating Requirements for PathologyDevices, by Technology, through 2014 ($ Millions)
Regional Technology Requirements for
Pathology Device Coatings
Table 118 Regional Coating Requirements for
Pathology Devices, through 2014 ($ Millions)
Personal Use
Table 119 Personal Use Monitoring Devices
Table 120 Personal Use Therapeutic Devices
Table 121 Miscellaneous Personal Use Medical Devices
Technology Requirements for Personal Use Device Coatings
Table 122 Global Coating Requirements for Personal Use Devices, by Technology. through 2014 ($ Millions)
Regional Requirements for Personal Use Device
Coatings
Table 123 Regional Coating Requirements for Personal Use Devices, through 2014 ($ Millions)
Physical Medicine
Table 124 Physical Medicine Diagnostic Devices
Table 125 Physical Medicine Prosthetic Devices
Table 126 Physical Medicine Therapeutic Devices
Technology Requirements for Physical Medicine Device Coatings
Table 127 Global Coating Requirements for Physical Medicine Devices, by Technology, through 2014($ Millions)
Regional Requirements for Physical Medicine Device Coatings
Table 128 Regional Coating Requirements for Physical
Medicine Devices, through 2014 ($ Millions)
Radiology
Table 129 Radiology Diagnostic Devices
Table 130 Radiographic Therapeutic Devices
Technical Requirements for Radiology Device
Coatings
Table 131 Global Coating Requirements for RadiologyDevices, by Technology, through 2014 ($ Millions)
Regional Requirement for Radiology Device
Coatings
Table 132 Regional Coating Requirement for RadiologyDevices, through 2014 ($ Millions)
Respiratory Therapy
Table 133 Respiratory Diagnostic Devices
Table 134 Respiratory Monitoring Devices
Table 135 Therapeutic Respiratory Devices
Table 136 Miscellaneous Respiratory Devices
Technical Requirements for Respiratory Device
Coatings
Table 137 Global Coating Requirements for
Respiratory Therapy Devices, by Technology, through 2014 ($ Millions)
Regional Requirements for Respiratory Device
Coatings
Table 138 Regional Coating Requirements for
Respiratory Therapy Devices, through 2014($ Millions)
Urology
Table 139 Urology Diagnostic Devices
Table 140 Urology Prosthetic Devices
Table 141 Urology Surgical Devices
Table 142 Urology Therapeutic Devices
Technology Requirements for Urology Device
Coatings
Table 143 Global Coating Requirements for UrologyDevices, by Technology, through 2014 ($ Millions)
Regional Requirements for Urology Device
Coatings
Table 144 Regional Coating Requirements for UrologyDevices, through 2014 ($ Millions)

Appendix A: Businesses with Significant Industry

Involvement
4TH State
Abbott Laboratories
Accord Biomaterials
Acrymed
Adhesive Consultants
Advanced Medical Optics
Advansource Biomaterials
Aeonclad Coating
Affinergy
Agion Technologies
Alcon
All-Chemie
Allvivo Vascular
Angiotech Pharmaceuticals
Armoloy of Connecticut

Ast Products
Bacterin International
Baxter Healthcare
Biocoat
Biocompatibles International
Biomet
Biophan
Boston Scientific
Bristol-Myers Squibb
Cardiotech International
Carmeda
Cerac
Ceragenix Pharmaceuticals
Conor Medsystems
Cordis
Corin Group
Covalon
Curtiss-Wright Metal Treatment
Cv Therapeutics
Depuy Orthopaedics
Edwards Lifesciences
Hemoteq
Hydromer
I-Flow
Japan Medical Materials
Johnson & Johnson
Lombard Medical Technologies
MC3
Medtronic Cardiovascular
Micrus Endovascular
Miv Therapeutics
Nanocopoeia
Nerites
Nippon Electric Glass
Novartis Pharma
Nucryst Pharmaceuticals
Para Tech Coating
Parylene Coating Services
Polymerix
Smith & Nephew
Sono-Tek
Specialty Coating Systems
Spire
St. Jude Medical
Stryker
Surface Solutions Labs
Surmodics
Techni-Met
Thoratec
Tyrx Pharma
Wright Medical Technology
Wyeth
Zebra Technologies
Zimmer Holdings

Appendix B: Abstracts of Key Coating Patents

Adherent Flexible Hydrogel and Medicated Coatings
Aminoguanidinyl- and Alkoxyguanidinyl-Substituted
Phenyl Acetamides as Protease Inhibitors
An Apparatus for Coating Tubular Members
Angiotensin-(1-7) Eluting Polymer-Coated Medical
Device to Reduce Restenosis
Antibiotic Bonding of Vascular Prostheses and
Other Implants
Anti-Infective Covering for Percutaneous and
Vascular Access Device and Coating Method
Antithrombogenic Membrane Mimetic Compositions
and Methods
Antithrombogenic Retentive Catheter
Apparatus and Method for Electrostatic Spray
Coating of Medical Devices
Apparatus and Process for Coating Articles
Apparatus and Method for Coating ImplantableDevices
Bactericidal Coatings for Implants
Bi-Laminar, Hyaluronan Coatings with Silver-Based
Antimicrobial Properties
Biocompatible Carrier Containing Actinomycin D
Ceramic Cardiac Electrodes
Bioactive Agent-Release Coating
Biomedical Material for Improving The Adhesion and
Proliferation of Cells and A Modified Artificial Vessel
Bioactive Coating Composition and Methods
Bioabsorbable Brachytherapy Device
Bioprosthetic Heart Valves with High Calcification Resistance
Biostatic Coatings for The Reduction and Prevention of Bacterial Adhesion
Blood Circulation Apparatus Coupling Device That Improves Biocompatibility of Inner Surfaces with Treated Blood
Methods and Implants for Providing Radiation to A Patient Coated Orthopedic Implant Components
Collagen-Impregnated Dacron Graft
Coated Endovascular Stent
Coating Dispensing System and Method Using A
Solenoid Head for Coating Medical Devices
Coating Intraluminal Stents
Coated Orthopedic Implant Components
Composition Comprising Heparin as A
Nonthrombogenic Surface Coating Agent
Composition for Coating An Implantable Prosthesis
Coronary Stent with A Radioactive Radiopaque
Coating
Device and Process for Coating Stents
Device for Protecting Medical Devices during A


Coating Process
Drug-Release Stent Coating Process
Drug-Polymer-Coated Stent with Pegylated Styrenic
Block Copolymers
Echogenic Coatings
Eptfe Small Caliber Vascular Grafts with
Significant Patency Enhancement via A Surface
Coating Which Contains Covalently Bonded
Heparin
Ethylene Vinyl Alcohol-Dimethyl Acetamide
Composition and A Method of Coating A Stent
Fibrin-Coated Polymer Surfaces
Fluorinating Polymer Surfaces
Functionalized Polyurethanes
Glaucoma Shunt and A Method of Making and
Surgically Implanting of Same
Graft Polymerization of Substrate Surfaces
Grafting of Biocompatible Hydrophilic Polymers
onto Inorganic and Metal Surfaces
Hemocompatible Coatings on Hydrophobic Porous
Polymers
Heparin Delivery Method
Highly Crosslinked, Extremely Hydrophobic Nitric
Oxide-Releasing Polymers
Hydrophilic Polyvinylbutyral Alloys
Hydrophilic Polymer Blend
Intravascular Stent and Method

Local Drug Delivery
Lubricious Hydrophilic Coating for An
Intracorporeal Medical Device
Mechanical and Acoustical Suspension Coating of
Medical Implants
Medical Device with Surface Modification with
Superoxide Dismutase Mimic
Medical Devices with Durable and Lubricious
Polymeric Coating

Method and Apparatus for Polymer Application to
Intracorporeal Device
Method for Attachment of Biomolecules to Medical
Device Surfaces
Method for Coating An Implantable Device and
System for Performing The Method
Method for Coating Implantable Devices
Method for Delivering A Therapeutic Substance to A
Body Lumen

Method for Etching A Micropatterned Microdepot
Prosthesis
Method and Apparatus for Coating An Implantable
Device
Methods of Coating An Implantable Device Having
Depots Formed in A Surface Thereof
Method of Forming A Therapeutic Coating onto A
Surface of An Implantable Prosthesis
Medical Device Having Surface Modification with

Superoxide Dismutase Mimic
Methods for Coating Implants
Method of Improving The Biocompatibility of
Synthetic Polymers
Method of Reducing Protein Deposition in Sight
Correction Devices
Methods and Clinical Devices for The Inhibition or
Prevention of Mammalian Cell Growth
Method for Fine Bore Orifice Spray Coating of

Medical Devices and Prefilming Atomization
Method for Imparting A Bioactive Coating
Method for Making and Measuring A Coating on The
Surface of A Medical Device Using An Ultraviolet
Laser
Method for Manufacturing Medical Articles
Composed of Silicone Rubber Coated with
Collagen
Method for Growing An Alumina Surface on

Orthopaedic Implant Components
Method of Fabricating A Biocompatible Stent
Method for Microporous Surface Modification of
Implantable Metallic Medical Articles
Method for Pretreating The Surface of A Medical
Device
Method for Roll Coating Multiple Stents
Method for Spray Coating A Medical Device Having A
Tubular Wall Such as A Stent

Method for Spray Coating Medical Devices
Method for Spray-Coating A Medical Device Having A
Tubular Wall Such as A Stent
Method for Treating Medical Devices Using Glycerol
and An Antimicrobial Agent
Method of Making Antimicrobial Polymeric Surfaces
Method to Stabilize Tdmac Heparin Coating
Methods for Polymeric Coatings Stents
Methods for Surface Modification

Methods of Forming A Coating for A Prosthesis
Methods of Polymer Impregnation
Microporous Covered Stents and Method of Coating
Nonirritating Antimicrobial Coating for Medical
Implants
Nucleic Acid Coating Compositions and Methods
Optimized Dosing for Drug Coated Stents
Palladium-Coated Implant
Photoactivatable Nucleic Acids

Physical Vapor Deposition of Radiopaque Markings
on A Graft
Sterilization of Bioactive Coatings
Plasma-Crosslinked Hydrophilic Coating
Porous Prosthesis and A Method of Depositing
Substances into The Pores
Polybifunctional Reagent with A Polymeric
Backbone and Latent Reactive Moieties and
Bioactive Groups

Polycarbonate-Polyurethane Dispersions for
Thrombo-Resistant Coatings
Polymer-Coated Stent Structure
Polymeric Coatings Containing A Ph Buffer Agent
Polyurethanes Grafted with Polyethylene Oxide
Chains Containing Covalently Bonded Heparin
Preparation of Ophthalmic Compositions
Process for Coating A Surface of A Metallic Stent
Process for Coating A Surface of A Stent

Process for Coating A Surface of A Stent
Process for Impregnating A Porous Material with A
Crosslinkable Composition
Process for Preparing Surface Modification
Substances
Radioactive Balloon for Dilation Catheter System
and Process for Preparation
Radioactive Medical Devices
Radioactive Seed Implants

Resin Composition and Manufacturing Method
Selective Coating of Medical Devices
Semiautomatic Coating System Methods for Coating
Medical Devices
Silyl and Heparin Compositions
Soft X-Ray Emitting Radioactive Stent
Stent Coating Device
Stent Coating
Stent with Antithrombogenic Coating

Stent with Radiopaque Coating Consisting of
Particles in A Binder
Surface Coating Agents
Surface Features of An Implantable Medical Device
Surgical Lubricants
Therapeutic Use of Polymers
Therapeutic, Diagnostic, or Hydrophilic Coating for
An Intracorporeal Medical Device
Thrombo-Resistant Nonthrombogenic Objects

Formed from Resin-Graphite Mixtures
Triggered Release Hydrogel Drug-Delivery System
Variable Surface Area Stent
Vascular Biomaterial Devices
Vascular Biomaterial
Vascular Prosthesis and Method of Making The Same
Vascular Prosthesis Having A Composite Structure
Water-Soluble Coating Agents Bearing Initiator Groups
Zwitterionic Materials
Zwitterionic Polymer Blend Materials
Zwitterionic Polymers
Summary Table Global Medical Device Coating Market,by Region, through 2014 ($ Millions)
Table 1 Iso 10993 Standards Pertaining to Medical Device Coatings
Table 2 Proposed Standards under Consideration by Astm International Committee on Medical and Surgical Materials and Devices
Table 3 Astm Coating-Related Standards
Table 4 Medical Devices, by Type and Variation
Table 5 Fda Recalls Involving Coatings
Table 6 Medical Device Coating Patents Issued since 1976
Table 7 Key Drug-Related Coating Patents
Table 8 Heparin-Related Coating Patents
Table 9 Stent-Related Coating Patents
Table 10 Global Growth in Older Populations (% of Population Age 65 or Older in 2015)
Table 11 Most Common Inpatient Surgical Procedures for Older Americans
Table 12 Average Length of Hospital Stay by Sex and Age (Days)
Table 13 Three Perspectives on The Coatings Market
Table 14 Global Requirement for Medical Device Coatings
Used in All Medical Specialties, by Region, through 2014($ Millions)
Table 15 Nafta Countries
Table 16 European Union Countries
Table 17 Other Developed Countries
Table 18 Rest of The World
Table 19 Requirement for Medical Device Coatings, by Technology, through 2014 ($ Millions)
Table 20 Requirement for All Coating Technologies, by All Medical Specialties, through 2014 ($ Millions)
Table 21 Requirement for Alloy Coating Technology, by Medical Specialty, through 2014 ($ Millions)
Table 22 Requirement for Ceramic Technology Coatings, by Medical Specialty, through 2014 ($ Millions)
Table 23 Active Agents and Carriers Used in Combination Product Coatings
Table 24 Requirement for Combination Product Technologies, by Medical Specialty, through 2014 ($ Millions)
Table 25 Requirement for Energy-Absorbing Technology Coatings, by Medical Specialty, through 2014 ($ Millions)
Table 26 Requirement for Energy-Emitting Technologies, by Medical Specialty, through 2014 ($ Millions)
Table 27 Requirement for Micro- and Nanotechnology Coatings, by Medical Specialty, through 2014 ($ Millions)
Table 28 Requirement for Protective Polymer Technologies, by Medical Specialty, through 2014 ($ Millions)
Table 29 Global Requirement for Surface Treatment Technologies, by Medical Specialty, through 2014 ($ Millions)
Table 30 Factors Influencing The Requirement for New Coatings
Table 31 Anesthesia Diagnostic Devices
Table 32 Anesthesia Monitoring Devices
Table 33 Therapeutic Anesthesia Devices
Table 34 Miscellaneous Anesthesia Devices
Table 35 Global Coating Requirements for AnesthesiaDevices, by Technology, through 2014 ($ Millions)
Table 36 Regional Coating Requirements for AnesthesiaDevices ($ Millions)
Table 37 Cardiovascular Diagnostic Devices
Table 38 Cardiovascular Monitoring Devices
Table 39 Cardiovascular Prosthetic Devices
Table 40 Cardiovascular Surgical Devices
Table 41 Cardiovascular Therapeutic Devices
Table 42 Global Coating Requirements for Cardiovascular Devices, by Technology, through 2014 ($ Millions)
Table 43 Regional Coating Requirements for
Cardiovascular Devices, through 2014 ($ Millions)
Table 44 Clinical Chemistry Test Systems
Table 45 Clinical Laboratory Instruments
Table 46 Global Coating Requirements for Clinical Medicine Devices, by Technology, through 2014 ($ Millions)
Table 47 Regional Coating Requirements for Clinical Medicine Devices, through 2014 ($ Millions)
Table 48 Clinical Toxicology Test Systems
Table 49 Global Coating Requirements for Clinical Toxicology Devices, by Technology, through 2014 ($ Millions)
Table 50 Regional Coating Requirements for Clinical
Toxicology Devices, through 2014 ($ Millions)
Table 51 Dental Diagnostic Devices
Table 52 Dental Prosthetic Devices
Table 53 Dental Surgical Devices
Table 54 Dental Therapeutic Devices
Table 55 Miscellaneous Dental Devices
Table 56 Global Coating Requirement for Dental Devices, by Technology, through 2014 ($ Millions)
Table 57 Regional Coating Requirements for DentalDevices, through 2014 ($ Millions)
Table 58 Ear, Nose, and Throat Diagnostic Devices
Table 59 Ear, Nose, and Throat Prosthetic Devices
Table 60 Ear, Nose, and Throat Surgical Devices
Table 61 Ear, Nose, and Throat Therapeutic Devices
Table 62 Global Coating Requirement for Ear, Nose, and Throat Devices, by Technology, through 2014 ($ Millions)
Table 63 Global Coating Requirement for Ear, Nose, and
Throat Devices, by Region, through 2014 ($ Millions)
Table 64 Gastroenterology Diagnostic Devices
Table 65 Gastroenterology-Urology Surgical Devices
Table 66 Gastroenterology-Urology Therapeutic Devices
Table 67 Global Coating Requirement for
Gastroenterology Devices, by Technology, through 2014 ($ Millions)
Table 68 Regional Coating Requirement for Gastroenterology Devices, through 2014 ($ Millions)
Table 69 Surgical Devices
Table 70 Global Coating Requirement for General and Plastic Surgery Devices, by Technology, through 2014 ($ Millions)
Table 71 Regional Coating Requirement for General and Plastic Surgery Devices, through 2014 ($ Millions)
Table 72 Monitoring Devices for General Hospital Use
Table 73 Therapeutic Devices for General Hospital Use
Table 74 Miscellaneous Medical Devices for General
Hospital Use
Table 75 Global Coating Requirements for General Hospital Devices, by Technology, through 2014 ($ Millions)
Table 76 Regional Coating Requirements for General Hospital Devices, through 2014 ($ Millions)
Table 77 Hematology Instrumentation
Table 78 Automated and Semi-Automated HematologyDevices
Table 79 Manual Hematology Devices
Table 80 Blood Bank Supplies
Table 81 Global Coating Requirements for HematologyDevices, by Technology, through 2014 ($ Millions)
Table 82 Regional Coating Requirements for HematologyDevices, through 2014 ($ Millions)
Table 83 Immunology Laboratory Equipment and Reagents
Table 84 Tumor Associated Antigen Immunological Test Systems
Table 85 Global Coating Requirement for ImmunologyDevices, by Technology, through 2014 ($ Millions)
Table 86 Regional Coating Requirement for ImmunologyDevices, through 2014 ($ Millions)
Table 87 Devices Used in Microbiology Devices
Table 88 Global Coating Requirement for Devices Used in Microbiology, through 2014 ($ Millions)
Table 89 Regional Coating Requirements for Devices Used
in Microbiology, through 2014 ($ Millions)
Table 90 Neurological Diagnostic Devices
Table 91 Neurological Surgical Devices
Table 92 Neurological Therapeutic Devices
Table 93 Global Coating Requirements for NeurologyDevices, by Technology, through 2014 ($ Millions)
Table 94 Regional Coating Requirements for NeurologyDevices, through 2014 ($ Millions)
Table 95 Obstetrical and Gynecological DiagnosticDevices
Table 96 Obstetrical and Gynecological MonitoringDevices
Table 97 Obstetrical and Gynecological ProstheticDevices
Table 98 Obstetrical and Gynecological Surgical Devices
Table 99 Obstetrical and Gynecological TherapeuticDevices
Table 100 Assisted Reproduction Devices
Table 101 Coating Requirement for Obstetrics and Gynecology Devices, by Technology, through 2014 ($ Millions)
Table 102 Regional Coating Requirement for Obstetrics and Gynecology Devices, through 2014 ($ Millions)
Table 103 Ophthalmic Diagnostic Devices
Table 104 Ophthalmic Prosthetic Devices
Table 105 Ophthalmic Surgical Devices
Table 106 Ophthalmic Therapeutic Devices
Table 107 Global Coating Requirement for Ophthalmology, by Technology, through 2014 ($ Millions)
Table 108 Regional Coating Requirements for Ophthalmology Devices, through 2014 ($ Millions)
Table 109 Orthopedic Diagnostic Devices
Table 110 Orthopedic Prosthetic Devices
Table 111 Orthopedic Surgical Devices
Table 112 Global Coating Requirements for OrthopedicsDevices, by Technology, through 2014 ($ Millions)
Table 113 Regional Coating Requirements for Orthopedics Devices, through 2014 ($ Millions)
Table 114 Pathology Instrumentation
Table 115 Automated and Semi-Automated PathologyDevices
Table 116 Manual Pathology Devices
Table 117 Global Coating Requirements for Pathology Devices, by Technology, through 2014 ($ Millions)
Table 118 Regional Coating Requirements for Pathology Devices, through 2014 ($ Millions)
Table 119 Personal Use Monitoring Devices
Table 120 Personal Use Therapeutic Devices
Table 121 Miscellaneous Personal Use Medical Devices
Table 122 Global Coating Requirements for Personal Use Devices, by Technology.through 2014 ($ Millions)
Table 123 Regional Coating Requirements for Personal Use Devices, through 2014 ($ Millions)
Table 124 Physical Medicine Diagnostic Devices
Table 125 Physical Medicine Prosthetic Devices
Table 126 Physical Medicine Therapeutic Devices
Table 127 Global Coating Requirements for Physical Medicine Devices, by Technology, through 2014 ($ Millions)
Table 128 Regional Coating Requirements for Physical Medicine Devices, through 2014 ($ Millions)
Table 129 Radiology Diagnostic Devices
Table 130 Radiographic Therapeutic Devices
Table 131 Global Coating Requirements for RadiologyDevices, by Technology, through 2014 ($ Millions)
Table 132 Regional Coating Requirement for RadiologyDevices, through 2014 ($ Millions)
Table 133 Respiratory Diagnostic Devices
Table 134 Respiratory Monitoring Devices
Table 135 Therapeutic Respiratory Devices
Table 136 Miscellaneous Respiratory Devices
Table 137 Global Coating Requirements for Respiratory Therapy Devices, by Technology, through 2014 ($ Millions)
Table 138 Regional Coating Requirements for Respiratory Therapy Devices, through 2014 ($ Millions)
Table 139 Urology Diagnostic Devices
Table 140 Urology Prosthetic Devices
Table 141 Urology Surgical Devices
Table 142 Urology Therapeutic Devices
Table 143 Global Coating Requirements for UrologyDevices, by Technology, through 2014 ($ Millions)
Table 144 Regional Coating Requirements for UrologyDevices, through 2014 ($ Millions)

List of Figures

Summary Figure Global Medical Device Coating Market, by Region, 2009 and 2014 ($ Millions)
Figure 1 Global Requirement for Medical Device Coatings Used in All Medical Specialties, by Region, through 2014 ($ Millions)
Figure 2 Global Requirement for Coating Materials, 2014($ Millions)