Medical Plastics

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Medical Plastics
Published on June 2010

Report Summary

The U.S. medical plastics market is expected to reach almost 3.5 billion pounds by the end of 2010 and will grow at a compound
annual growth rate (CAGR) of about 5%, consuming about 4.4 billion pounds by 2015.

Commodity thermoplastics dominate the market with a little more than 55% of total volume. This sector is estimated at nearly 2 billion
pounds in 2010 and should increase at a compound annual growth rate (CAGR) of 4.8% to reach 2.5 billion pounds in 2015.

TPEs, engineering resins, and thermosets will show the most significant growth rates over the next 5 years although they only
constitute about 20% of total volume. Of these, TPEs will experience the highest compound annual growth rate (CAGR) of 6.2%, from
68 million pounds in 2010 to 92 million pounds in 2015.

Table of Content

Chapter- 1: INTRODUCTION -- Complimentary

STUDY GOALS AND OBJECTIVES 1
REASONS FOR DOING STUDY 1
SCOPE OF REPORT 1
METHODOLOGY 2
ABOUT THE AUTHOR 2
RELATED BCC REPORTS 2
BCC ONLINE SERVICES 2
DISCLAIMER 3

Chapter-2: SUMMARY

SUMMARY TABLE U.S. MEDICAL PLASTICS MARKET BY RESIN, THROUGH 2015 (MILLION POUNDS) 4
SUMMARY FIGURE U.S. MEDICAL PLASTICS MARKET BY RESIN, 2009-2015 (MILLION POUNDS) 5
SUMMARY (CONTINUED) 6

Chapter-3: HEALTHCARE INDUSTRY

BACKGROUND 7
CONSUMER CHARACTERISTICS AND FACTORS AFFECTING DEMAND 8
CONSUMER CHARACTERISTICS AND ' (CONTINUED) 9

Chapter-4: MEDICAL DEVICE INDUSTRY

BACKGROUND 10

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OVERALL STRUCTURE OF THE MEDICAL DEVICE INDUSTRY 11
OVERVIEW 11
TABLE 1 U.S MEDICAL INDUSTRY: PRINCIPAL MATERIALS, PRODUCER TYPES, MAJOR PRODUCTS AND PRINCIPAL
CONSUMERS 11
VALUE OF SHIPMENTS OF MEDICAL DEVICES 11
TABLE 2 VALUE OF SHIPMENTS OF MEDICAL DEVICES, 1980-2010 ($ BILLIONS) 11
MAJOR MEDICAL DEVICE COMPANIES 12
TABLE 3 TOP MAJOR MEDICAL DEVICE COMPANIES, 2008 ($ BILLIONS) 12
KEY MEDICAL DEVICE COMPANY MERGERS AND ACQUISITIONS 13
TABLE 4 KEY SELECTED MEDICAL DEVICE COMPANY MERGERS AND ACQUISITIONS ($ MILLIONS) 13

Chapter-5: MARKETING ASPECTS OF THE HEALTHCARE INDUSTRY

OVERVIEW 14
LARGE PURCHASING/MARKETING GROUPS CHANGING THE FACE OF MEDICAL DEVICE MARKETING 14
OFFSHORE COMPETITION 15
CONTRACT MANUFACTURING 15
BACKGROUND 15
THE DECISION VARIABLES FOR CONTRACT MANUFACTURING 16
CHOOSING A CONTRACT MANUFACTURER 17
OFFSHORE OUTSOURCING 17
CHANGING DEMOGRAPHICS AND LIFESTYLES 18
HEALTHCARE COST CONTAINMENT 19
OVERVIEW 19
MANAGED CARE 19
HOME HEALTHCARE 20
SHIFTS IN PLASTIC USAGE 21

Chapter-6: LEGISLATIVE AND REGULATORY ISSUES

OVERVIEW 22
BACKGROUND 22
BACKGROUND (CONTINUED) 23
PLASTICS TESTING PROCEDURES 24
BIOCOMPATIBILITY ISSUES 24
OVERVIEW 24
SCOPE 25
RECENT DEVELOPMENTS 25
BAYESIAN STATISTICAL METHODS 25
THE FDA SHORTENS STERILITY 'DELAYS' 25
THE FDA ALSO REVIEWS USAGE OF COMPLICATED MEDICAL DEVICES AT THE HOME 26

Chapter-7: ENVIRONMENTAL ISSUES

BACKGROUND 27
SPECTER OF MEDICAL WASTE 27
SOURCE REDUCTION 28
RECYCLING 28



SOLID WASTE DISPOSAL 29

Chapter-8: PATENTS

OVERVIEW 30
RECENT SELECTED MEDICAL DEVICE-RELATED PATENTS 30
RECENT SELECTED MEDICAL ' (CONTINUED) 31
RECENT SELECTED MEDICAL ' (CONTINUED) 32

Chapter-9: MEDICAL DEVICE PLASTIC PROCESSES

INJECTION MOLDING 33
BACKGROUND 33
DETAILS 33
EXTRUSION 34
BACKGROUND 34
SINGLE- AND TWIN-SCREW EXTRUSION 34
EXTRUSION AND MELT FILM FABRICATION 34
BLOWN FILMS 35
FILM CASTING 35
SOLVENT CASTING 36
BLOW MOLDING 36
OVERVIEW 36
EXTRUSION BLOW MOLDING 36
INJECTION BLOW MOLDING 37
STRETCH BLOW MOLDING 37
THERMOFORMING 38
HISTORY 38
OVERVIEW 38
APPLICATIONS 38

Chapter-10: STERILIZATION TECHNIQUES

OVERVIEW OF METHODS 39
ETO GAS STERILIZATION 39
RADIATION STERILIZATION 40
GAMMA RADIATION 40
E-BEAM RADIATION 41
VAPORIZED HYDROGEN PEROXIDE 41
DRY-HEAT STERILIZATION 41
GAMMA RADIATION VS ETO 41
THE MOVE TO GLOBAL STERILIZATION STANDARDS 42
POLYMER REACTIONS TO STERILIZATION METHODS 42
BACKGROUND 42
PVC 42
POLYPROPYLENE 43
POLYETHYLENE 43
ABS AND SAN 43



POLYCARBONATE 43
POLYSTYRENE 44
POLYESTERS 44
RADIATION RESISTANCE 44
TABLE 5 RADIATION RESISTANCE OF KEY MEDICAL PLASTICS 45

Chapter-11: VALIDATION TESTS FOR MEDICAL THERMOPLASTICS

BACKGROUND 46
RATINGS AND TESTS 46
TABLE 6 SELECTED TESTS FOR PLASTICS USED IN MEDICAL APPLICATIONS 47
SELECTED STERILIZATION STANDARDS FOR MEDICAL DEVICES 48
TABLE 7 SELECTED/RANDOM EXAMPLES OF STERILIZATION STANDARDS FOR MEDICAL DEVICES 48

Chapter-12: APPLICATIONS

BACKGROUND 49
POINT-OF-CARE TESTING 49
INFUSION DRUG DELIVERY THERAPY 49
OTHER APPLICATIONS 50
WASTE REDUCTION 50
STERILIZATION AND BIOCOMPATIBILITY 50
MEDICAL DEVICE CATEGORY CRITERIA 51
ECONOMIC ASPECTS AND OUTLOOK 52
APPLICATION MARKET ESTIMATES AND FORECASTS 53
TABLE 8 U.S. MEDICAL PLASTICS MARKET BY OVERALL APPLICATION, THROUGH 2015 (MILLION POUNDS) 53
NONDISPOSABLES 53
OVERVIEW 53
MARKET ESTIMATES AND FORECASTS 54
TABLE 9 U.S. NONDISPOSABLE MEDICAL PLASTIC MARKET BY APPLICATION, THROUGH 2015 (MILLION POUNDS) 54
SURGICAL INSTRUMENTS 54
Overview 54
Specific Products 55
Technical Requirements 55
Materials Used 56
Sutures 56
Other Surgery-Related Plastic Medical Devices 57
Blood Centrifuge Bowls 57
Blood Oxygenators 58
Cardiopulmonary Supplies 58
Trocars 58
Surgical Procedures Will Affect Medical Devices and Eventually Resin Selection 59
Examples of Plastic Surgical Instruments 59
Manufacturers of Surgical Instruments 59
TABLE 10 SELECTED KEY MANUFACTURERS OF SURGICAL INSTRUMENTS 59
TABLE 10 (CONTINUED) 60
Market Estimates and Forecasts 60
TABLE 11 U.S. SURGICAL INSTRUMENT/RELATED EQUIPMENT MARKET BY RESIN, THROUGH 2015 (MILLION POUNDS) 60



TABLE 12 U.S. COMMODITY THERMOPLASTIC SURGICAL INSTRUMENTS/RELATED EQUIPMENT MARKET, THROUGH 2015
(MILLION POUNDS) 61
TABLE 13 U.S. STYRENIC RESIN SURGICAL INSTRUMENTS/RELATED EQUIPMENT MARKET, THROUGH 2015 (MILLION
POUNDS) 61
TABLE 14 U.S. MARKET IN OTHER RESINS IN SURGICAL INSTRUMENTS/RELATED EQUIPMENT, THROUGH 2015 (MILLION
POUNDS) 62
TESTING AND DIAGNOSTIC EQUIPMENT 62
Overview 62
Diagnostic Equipment 62
Examples of Diagnostic/Testing Equipment 63
The Medical Testing Business 63
Key Medical Testing and Diagnostic Companies 63
TABLE 15 KEY SELECTED MEDICAL TESTING AND DIAGNOSTIC COMPANIES 64
Electromedical Equipment 64
Clinical Laboratory Equipment 64
Polymers Used 64
Overview 64
Specific Examples 65
TABLE 16 U.S. TESTING/DIAGNOSTIC EQUIPMENT MARKET BY RESIN, THROUGH 2015 (MILLION POUNDS) 66
TABLE 17 U.S. COMMODITY THERMOPLASTIC TESTING/DIAGNOSTIC EQUIPMENT MARKET, THROUGH 2015 (MILLION
POUNDS) 66
TABLE 18 U.S. STYRENIC RESIN TESTING/DIAGNOSTIC EQUIPMENT MARKET, THROUGH 2015 (MILLION POUNDS) 67
TABLE 19 U.S. MARKET IN OTHER RESINS IN TESTING/DIAGNOSTIC EQUIPMENT, THROUGH 2015 (MILLION POUNDS) 67
IMPLANTS AND PROSTHETIC DEVICES 67
Background 67
Overview 68
Scope 68
Thermoplastic Materials Used 68
Overview 68
Use of Ultra-High Molecular Weight Polyethylene (UHMWPE) 69
Organ Replacements 69
Implanted and Ingested Drug Delivery Systems 70
Examples of Prostheses and Implant Categories Using Plastics 71
New Plastic Developments Related to Artificial Limbs 71
An Example of a Plastic Supplier's Prosthetic Products 72
New Developments 72
Plastic Coatings on Neural Implants 72
Above Knee Prosthesis Fabrication Developments 72
Prosthesis that Can Mimic the Resilience and Flexibility of the Human Hand 73
TABLE 20 U.S. PROSTHESES/IMPLANTS MARKET BY RESIN, THROUGH 2015 (MILLION POUNDS) 73
TABLE 21 U.S. COMMODITY THERMOPLASTIC PROSTHESES/IMPLANTS MARKET, THROUGH 2015 (MILLION POUNDS) 74
TABLE 22 U.S. MARKET IN OTHER RESINS USED IN PROSTHESES/IMPLANTS, THROUGH 2015 (MILLION POUNDS) 74
DENTAL AND OPHTHALMIC PRODUCTS 74
Overview 74
Polymers Used 75
Plastic Lenses 76



Contact Lenses 77
Dental Restorative Materials 77
Amalgams 77
Composite Resins 77
Glass Ionomer Cement 78
Dentures 78
TABLE 23 U.S. DENTAL/OPHTHALMIC MARKET BY RESIN, THROUGH 2015 (MILLION POUNDS) 78
TABLE 24 SPECIFIC RESIN USAGE IN U.S. DENTAL/OPHTHALMIC MARKET, THROUGH 2015 (MILLION POUNDS) 79
DISPOSABLE MEDICAL DEVICES 79
OVERVIEW 79
REUSE OF MEDICAL DISPOSAL CONTROVERSY 80
SOME RECENT OBSERVATIONS 80
Plastics vs. Metals for Single-Use Devices 80
Plastics Medical Device Molders Views 81
TABLE 25 U.S. DISPOSABLE MEDICAL PLASTIC MARKET BY APPLICATION, THROUGH 2015 (MILLION POUNDS) 81
MEDICAL BAGS 82
Background 82
Intravenous Solution Bags 82
Fluid Administration Systems (Including Collection Bags) 83
Background 83
Related Products 83
Enema Bags 83
Blood Bags 84
Pouches and Other Applications 84
Alternatives to PVC in Medical Bags 85
Overview 85
Viable PVC Replacement Materials 85
Medical Bags Manufacturers 86
TABLE 26 SELECTED KEY MEDICAL BAG MANUFACTURERS 86
TABLE 27 U.S. MEDICAL BAG MARKET BY RESIN, THROUGH 2015 (MILLION POUNDS) 87
TABLE 28 U.S. BLOOD BAG MARKET BY RESIN, THROUGH 2015 (MILLION POUNDS) 88
TABLE 29 U.S. MARKET IN OTHER FLUID ADMINISTRATION BAGS BY RESIN, THROUGH 2015 (MILLION POUNDS) 88
TABLE 30 U.S. IV BAG MARKET BY RESIN, THROUGH 2015 (MILLION POUNDS) 88
SYRINGES 89
Background 89
Products and Applications 89
Syringe Alternatives 90
Syringe Innovations 90
Syringe Innovations (Continued) 91
Prefilled Syringe Historical Aspects 92
Materials Used 92
Polymer Usage 92
Recent Developments of Plastics Usage in Syringes 93
Self-Administration Becomes a Major Issue 94
Warnings against Reuse of Plastic Syringes 94



No Needles 94
An Interesting Observation 95
Major Syringe Manufacturers 95
TABLE 31 OTHER SELECTED SYRINGE MANUFACTURERS 95
TABLE 32 U.S. MEDICAL DEVICE MARKET BY RESIN: SYRINGES, THROUGH 2015 (MILLION POUNDS) 96
LABWARE 96
Background 96
Resins Used 97
TABLE 33 EXAMPLES OF DISPOSABLE MEDICAL PLASTIC LABWARE 97
TABLE 34 SELECTED PLASTIC MEDICAL LABWARE SUPPLIERS 98
TABLE 35 U.S. MEDICAL LABWARE MARKET BY RESIN, THROUGH 2015 (MILLION POUNDS) 98
CATHETERS 99
Background 99
Manufacturing a Foley Catheter 100
Property Criteria 100
TABLE 36 RESIN PROPERTY CRITERIA ¾ CATHETERS 101
Cardiac Usage 101
Demand for Plastics 102
Materials 102
Intravenous Products 102
Catheter Trends 103
Overview 103
Smaller and Smaller Catheters 103
Shifts in Plastic Usage 103
Catheter Manufacturers 104
TABLE 37 SELECTED KEY CATHETER MANUFACTURERS 104
TABLE 38 U.S. CATHETER/IV UNIT MARKET BY RESIN, THROUGH 2015 (MILLION POUNDS) 105
KITS 105
Overview 105
Performance Criteria 106
TABLE 39 MATERIAL PROPERTY CRITERIA¾ KITS 107
Surgical Kits 107
TABLE 40 U.S. MEDICAL MARKET BY RESIN: KITS, THROUGH 2015 (MILLION POUNDS) 108
TUBING 108
Products and Applications 108
Stainless Steel Medical Tubing Increasing 109
Plastic Medical Tubing Niches 109
Properties 109
Resin Components and Requirements 109
PVC Usage 110
Features of Medical Tubing 111
TABLE 41 COMMON FEATURES OF AND SELECTED APPLICATIONS FOR PRIMARY RESINS USED IN MEDICAL TUBING 111
Applications 112
TABLE 42 SAMPLE APPLICATIONS FOR FLEXIBLE MEDICAL TUBING BY MAJOR CATEGORY 112



Current Status of PVC Replacement 112
Multilayer Tubing 113
Material Advancements 114
Selected Plastic Medical Tubing Extruders 114
TABLE 43 SELECTED PLASTIC MEDICAL TUBING EXTRUDERS 114
Recent Developments 114
Bioabsorbable Medical Tubes 114
Complex Composite Tubes Moving In 115
Endoscopic Microtubes 115
Thinner Tubing 115
TABLE 44 U.S. MEDICAL PACKAGING MARKET BY RESIN: TUBING, THROUGH 2015 (MILLION POUNDS) 116
GLOVES 116
Background 116
Medical Gloves 117
Glove Protection Standards 117
Polymers Used 117
Latex Allergy Issue 117
Alternatives to Latex Rubber for Gloves 118
Medical Gloves Manufacturers 119
TABLE 45 SELECTED KEY MEDICAL GLOVE MANUFACTURERS AND MAJOR PRODUCTS 119
TABLE 46 U.S. MEDICAL GLOVE MARKET BY RESIN, THROUGH 2015 (MILLION POUNDS) 120
UTENSILS 120
Background 120
TABLE 47 U.S. MEDICAL UTENSIL MARKET BY RESIN, THROUGH 2015 (MILLION POUNDS) 121
TRAYS 121
Background 121
TABLE 48 RESIN PROPERTY CRITERIA ¾ TRAYS 122
Sterilization 122
Thermoform or Injection Mold' 122
Property Parameters for Choosing Tray Materials 123
Tray Designs for Different Environments 123
Medical Tray Manufacturers 124
TABLE 49 SELECTED PLASTIC MEDICAL TRAY MANUFACTURERS 124
Recent Developments and New Products Related to Medical Tray Packaging 124
Rigid Trays Should Have High Impact Qualities 124
Tray Films 125
Secondary Trays 125
Custom Trays 125
New Medical Tray Designs 125
Multi-Resin Trays 125
Polypropylene Usage 126
HIPS Involvement 126
TABLE 50 U.S. MEDICAL DEVICE MARKET BY RESIN: TRAYS, THROUGH 2015 (MILLION POUNDS) 126



Chapter-13: RESINS USED IN MEDICAL DEVICES

BACKGROUND 127
MATERIAL SELECTION 127
TARGETED AREAS FOR MEDICAL PLASTICS 128
RESIN OVERVIEW 128
BACKGROUND 128
COMMODITY THERMOPLASTICS 128
STYRENICS 129
ENGINEERING RESINS 129
THERMOSET RESINS 129
ELASTOMERS 130
MISCELLANEOUS RESINS 130
CHANGING REQUIREMENTS 130
PROPERTY REQUIREMENTS 131
OTHER DEVELOPMENTS 131
FAILURE OF PLASTIC MEDICAL DEVICES 132
PHYSICAL PROPERTY EFFECTS ON RESIN MATERIALS 133
OVERVIEW 133
IMPACT STRENGTH 133
STRESS-STRAIN BEHAVIOR 133
HEAT RESISTANCE 134
CHEMICAL RESISTANCE 134
CLARITY OR TRANSPARENCY 135
BONDABILITY 135
SUMMARY OF PHYSICAL PROPERTY CHARACTERISTICS OF MEDICAL PLASTICS 135
TABLE 51 PHYSICAL PROPERTY ADVANTAGES AND DISADVANTAGES OF MEDICAL PLASTICS 136
USE OF PLASTICS IN MEDICAL DEVICES 137
OVERVIEW 137
OVERALL RESIN USAGE 137
TABLE 52 SELECTED RESIN USAGE BY TYPE OF MEDICAL DEVICE 137
MEDICAL PLASTICS MARKET ESTIMATES AND FORECASTS 138
TABLE 53 U.S. MEDICAL PLASTICS MARKET BY RESIN, THROUGH 2015 (MILLION POUNDS) 139
TABLE 54 U.S. DISPOSABLE MEDICAL MARKET BY RESIN, THROUGH 2015 (MILLION POUNDS) 140
TABLE 55 U.S. NONDISPOSABLE MEDICAL MARKET BY RESIN, THROUGH 2015 (MILLION POUNDS) 140
COMMODITY THERMOPLASTICS 140
POLYVINYL CHLORIDE 140
Overview 140
Forms of PVC 141
A Versatile Resin 141
Producers 141
PVC Medical Device History 142
Medical Applications 142
Sterilization of PVC 143
PVC Still a Favorite for Medical Disposable Devices 143
PVC ENVIRONMENTAL PROBLEMS 144
Overview 144



A Little History 145
THE PVC REPLACEMENT ISSUE 145
Background 145
Potential PVC Replacement Resins 146
PVC Replacement Candidates 147
Overview 147
Polyolefins 147
Ethylene Vinyl Acetate (EVA) 147
COPEs 147
Laminated Polyolefins 147
Polyolefin Blends 148
Functionalized Polyolefins 148
TPEs 148
Polyurethanes 148
Nylon 148
MORE RECENT DEVELOPMENTS 149
Researchers Claim Techniques to Keep Plasticizers from Migrating 149
PVC Alternatives to Medical Tube Market 149
POLYPROPYLENE 149
Overview 149
Applications 150
Properties 151
Polypropylene Producers 151
TABLE 56 U.S. MARKET SHARES OF LEADING POLYPROPYLENE PRODUCERS (%) 151
Upgraded Polypropylene 151
Advances in Polypropylene Technologies 152
Highly Crystalline Grades 153
Reinforced Polypropylenes 153
Overview 153
Hi-Impact Grades 153
Random Copolymer Polypropylenes 154
Techniques Used to Impart Clarity 154
Sterilization of Polypropylene 154
Advantageous Medical Properties 155
Examples of Medical Devices 155
New Colorants for Medical Grade for Polypropylenes 155
High Clarity Metallocene Polypropylenes 156
POLYETHYLENES 156
Background 156
Need For Additives 156
Polyethylene Producers 156
TABLE 57 SELECTED MAJOR HDPE PRODUCERS AND CAPACITIES 157
Properties Useful for Medical Devices 157
Specific Examples of Medical Devices 157
Sterilization of Polyethylenes 158
Joint Replacements Depend on Polyethylene Resins 158
High Density Polyethylene (HDPE) 159



Overview 159
Background 159
Low Density Polyethylene (LDPE) 159
Overview 159
Markets and Applications 160
New Developments 160
TABLE 58 U.S. COMMODITY THERMOPLASTIC MEDICAL MARKET, THROUGH 2015 (MILLION POUNDS) 161
TABLE 59 U.S. COMMODITY THERMOPLASTICS BY DISPOSABLE MEDICAL APPLICATION, THROUGH 2015 (MILLION
POUNDS) 161
TABLE 60 U.S. DISPOSABLE COMMODITY THERMOPLASTICMEDICAL MARKET BY RESIN, THROUGH 2015 (MILLION
POUNDS) 162
TABLE 61 U.S. DISPOSABLE PVC MEDICAL MARKET BY APPLICATION, THROUGH 2015 (MILLION POUNDS) 163
TABLE 62 U.S. DISPOSABLE POLYPROPYLENE MEDICAL MARKET BY APPLICATION, THROUGH 2015 (MILLION POUNDS)
163
TABLE 63 U.S. DISPOSABLE HDPE MEDICAL MARKET BY APPLICATION, THROUGH 2015 (MILLION POUNDS) 164
TABLE 64 U.S. DISPOSABLE LDPE/LLDPE MEDICAL MARKET BY APPLICATION, THROUGH 2015 (MILLION POUNDS) 164
TABLE 65 U.S. COMMODITY THERMOPLASTICS BY NONDISPOSABLE MEDICAL APPLICATION, THROUGH 2015 (MILLION
POUNDS) 165
TABLE 66 U.S. NONDISPOSABLE COMMODITY THERMOPLASTIC MEDICAL MARKET BY RESIN, THROUGH 2015 (MILLION
POUNDS) 165
TABLE 67 U.S. NONDISPOSABLE PVC MEDICAL MARKET BY APPLICATION, THROUGH 2015 (MILLION POUNDS) 166
TABLE 68 U.S. NONDISPOSABLE POLYPROPYLENE MEDICAL MARKET BY APPLICATION, THROUGH 2015 (MILLION
POUNDS) 166
TABLE 69 U.S. NONDISPOSABLE HDPE MEDICAL MARKET BY APPLICATION, THROUGH 2015 (MILLION POUNDS) 166
STYRENICS 167
OVERVIEW 167
POLYSTYRENE 167
Background 167
General Purpose Polystyrene 167
Background 167
Characteristics of General Purpose Polystyrene 168
Processing 168
TABLE 70 FABRICATION METHODS AND USES FOR POLYSTYRENE 168
HIPS 168
PRODUCERS 169
MEDICAL APPLICATIONS OF POLYSTYRENE AND HIPS 170
THERMOPLASTIC STYRENE BLOCK COPOLYMERS 170
Background 170
Producers 171
Processing 171
Properties 171
Polymer Processes 172
TABLE 71 SBC MAJOR PRODUCTS SEGMENTED BY POLYMER PROCESS 172
Medical Properties and Applications 172
ACRYLONITRILE-BUTADIENE-STYRENE (ABS) 173
Background 173
Properties 173



Processing 174
General Grades 174
Producers 175
Overview 175
Capacities 175
TABLE 72 ESTIMATES OF NORTH AMERICAN ABS CAPACITIES 176
General ABS Applications 176
Overview 176
Medically Related Properties 177
Medical Product Applications 177
STYRENE-ACRYLONITRILE COPOLYMERS (SAN) 177
Overview 177
Properties 178
Producers and Suppliers 179
TABLE 73 U.S. STYRENIC RESIN MEDICAL MARKET BY TYPE OF RESIN, THROUGH 2015 (MILLION POUNDS) 180
TABLE 74 U.S. DISPOSABLE STYRENIC RESIN MEDICAL MARKET BY TYPE OF RESIN, THROUGH 2015 (MILLION POUNDS)
180
TABLE 75 U.S. STYRENIC RESINS MARKET BY DISPOSABLE MEDICAL APPLICATION, THROUGH 2015 (MILLION POUNDS)
181
TABLE 76 U.S. DISPOSABLE POLYSTYRENE/HIPS MEDICAL MARKET BY APPLICATION, THROUGH 2015 (MILLION POUNDS)
182
TABLE 77 U.S. NONDISPOSABLE STYRENIC RESIN MEDICAL MARKET BY RESIN, THROUGH 2015 (MILLION POUNDS) 182
TABLE 78 U.S. STYRENIC RESINS MARKET BY NONDISPOSABLE MEDICAL APPLICATION, THROUGH 2015 (MILLION
POUNDS) 183
TABLE 79 U.S. NONDISPOSABLE POLYSTYRENE/HIPS MEDICAL MARKET BY APPLICATION, THROUGH 2015 (MILLION
POUNDS) 183
TABLE 80 U.S. NONDISPOSABLE ABS MEDICAL MARKET BY APPLICATION, THROUGH 2015 (MILLION POUNDS) 184
ENGINEERING RESINS 184
OVERVIEW 184
POLYCARBONATES 184
Background 184
Property Advantages and Disadvantages 185
General Grades 185
Alloys/Blends 186
Properties 186
Impact of Bisphenol A on Polycarbonate Usage 186
Producers and Capacities 186
TABLE 81 NORTH AMERICAN POLYCARBONATE PRODUCERS AND CAPACITIES (MILLION POUNDS/YEAR) 187
Recent Capacity Developments 187
Specific Examples 189
Renal Dialysis 189
Surgical Instruments 189
Cardiac Surgery Products 190
Polycarbonate Sterilization 190



Bayer Material Science 190
NYLON 190
Background 190
Properties 191
Major Types of Nylons 191
Nylon 66 191
Nylon 6 192
TABLE 82 NYLON PRODUCERS AND CAPACITIES (MILLION POUNDS PER YEAR) 192
Nylon Sterilization 192
Nylon Process Makes Medical Prototype 193
POLYESTERS 193
Background 193
PET Resins 194
Engineering-Grade PET 194
TABLE 83 KEY NORTH AMERICAN PET PRODUCERS AND CAPACITIES (MILLION POUNDS/YEAR) 195
Polybutylene Terephthalate (PBT) 195
Background 195
Properties 196
Producers 196
TABLE 84 GLOBAL PBT PRODUCERS AND CAPACITIES (MILLION POUNDS) 197
Polyester Properties and Medical Applications 197
Sterilization and Disposal 198
POLYACETALS 198
Background 198
Grades 199
Properties 199
Processing 199
Producers 199
Medical Products 200
Recent Polyacetal Producer Activities 200
Ticona 200
Sabic to Build New Polyacetal Plant 200
POLYSULFONES 201
Background and Properties 201
Types of Polysulfones 201
Applications 202
Producer Scenario 202
BASF 203
Solvay 203
Sumitomo Chemical 203
Specific Polysulfone Medical Products 204



POLYIMIDES 205
Background 205
Polyetherimides (PEI) 205
POLYPHENYLENE SULFIDE (PPS) 206
Background 206
Properties 206
Producers 206
Applications 207
POLYKETONES 207
Background 207
Overview 207
PEEK Implants 208
New Polyketone Medical Products 208
PEEK Competes with Metals for Medical Implants 208
Evonik in Germany Introduces New PEEK Grades 209
PEEKs for Spinal Market 209
TABLE 85 U.S. ENGINEERING RESIN MEDICAL MARKET BY RESIN, THROUGH 2015 (MILLION POUNDS) 209
TABLE 86 U.S. DISPOSABLE ENGINEERING RESIN MEDICAL MARKET BY RESIN, THROUGH 2015 (MILLION POUNDS) 210
TABLE 87 U.S. ENGINEERING RESINS BY DISPOSABLE MEDICAL APPLICATION, THROUGH 2015 (MILLION POUNDS) 211
TABLE 88 U.S. DISPOSABLE POLYCARBONATE MEDICAL MARKET BY APPLICATION, THROUGH 2015 (MILLION POUNDS)
211
TABLE 89 U.S. DISPOSABLE POLYESTER MEDICAL MARKET BY APPLICATION, THROUGH 2015 (MILLION POUNDS) 212
TABLE 90 U.S. NONDISPOSABLE ENGINEERING RESIN MEDICAL MARKET BY RESIN, THROUGH 2015 (MILLION POUNDS)
212
TABLE 91 U.S. NONDISPOSABLE POLYCARBONATE MEDICAL MARKET BY APPLICATION, THROUGH 2015 (MILLION
POUNDS) 213
THERMOSETS 213
ACRYLICS 213
Background 213
Properties and Typical Products 213
Sheet 214
Applications 214
Commercial Acrylic Polymers 215
Producer/Supplier Activities and Developments 215
Background 215
Cyro Industries 215
Lucite International 215
Medical Products and Sterilization 216
Use in Medical Devices 216
New Medical Acrylics form Evonik 216
SILICONES 217
Background 217
Technology 217
New Products 218



Silicone Medical Device Producers 218
TABLE 92 SELECTED KEY SILICONE MEDICAL DEVICE PRODUCERS 219
POLYURETHANES 219
Overview 219
General Medical Applications 219
Market Estimates 220
TABLE 93 U.S. THERMOSET RESIN MEDICAL MARKET BY RESIN, THROUGH 2015 (MILLION POUNDS) 220
TABLE 94 U.S. DISPOSABLE THERMOSET RESIN MEDICAL MARKET BY RESIN, THROUGH 2015 (MILLION POUNDS) 221
TABLE 95 U.S. THERMOSET RESINS BY DISPOSABLE MEDICAL APPLICATION, THROUGH 2015 (MILLION POUNDS) 221
TABLE 96 U.S. DISPOSABLE ACRYLIC MEDICAL MARKET BY APPLICATION, THROUGH 2015 (MILLION POUNDS) 222
TABLE 97 U.S. DISPOSABLE SILICONE MEDICAL MARKET BY APPLICATION, THROUGH 2015 (MILLION POUNDS) 222
TABLE 98 U.S. THERMOSET RESINS BY NONDISPOSABLE MEDICAL APPLICATIONS, THROUGH 2015 (MILLION POUNDS)
223
TABLE 99 U.S. NONDISPOSABLE THERMOSET RESIN MEDICAL MARKET BY RESIN, THROUGH 2015 (MILLION POUNDS) 223
TABLE 100 U.S. NONDISPOSABLE ACRYLIC MEDICAL MARKET BY APPLICATION, THROUGH 2015 (MILLION POUNDS) 224
THERMOPLASTIC ELASTOMERS (TPEs) 224
OVERVIEW 224
TYPES OF TPEs 224
ADVANTAGES 225
DISADVANTAGES 225
PROCESSING 225
APPLICATIONS 225
RECENT TPE DEVELOPMENTS IN MEDICAL APPLICATIONS 225
Phthalate-Free TPEs for Medical Applications 225
TPEs for Medical Industry Masks 226
TPEs May Have Opportunities in Parenteral Closures 226
THERMOPLASTIC OLEFINS (TPOs) 226
Background and Properties 226
Competitive Scenario 227
COPEs 228
Background 228
Properties and Medical Applications 228
THERMOPLASTIC POLYURETHANES (TPUs) 228
Background 228
Medical Properties and Sterilization 229
TPU-SILICONE COPOLYMERS 231
TABLE 101 SELECTED MEDICAL SILICONE-POLYURETHANE COPOLYMER PRODUCTS 231
TABLE 102 U.S. TPE MEDICAL MARKET BY TYPE, THROUGH 2015 (MILLION POUNDS) 232
TABLE 103 U.S. DISPOSABLE TPE MEDICAL MARKET BY TYPE, THROUGH 2015 (MILLION POUNDS) 232
TABLE 104 U.S. TPE MARKET BY DISPOSABLE MEDICAL APPLICATION, THROUGH 2015 (MILLION POUNDS) 233
TABLE 105 U.S. DISPOSABLE TPU MEDICAL MARKET BY APPLICATION, THROUGH 2015 (MILLION POUNDS) 233
MISCELLANEOUS RESINS 234
OVERVIEW 234
FLUOROPOLYMERS 234



Background 234
Fluoropolymer Medical Device Suppliers 235
TABLE 106 SELECTED FLUOROPOLYMER MEDICAL DEVICE SUPPLIERS 235
LIQUID CRYSTAL POLYMERS 235
Background 235
Medical Properties, Products and Sterilization 236
POLYETHERIMIDES (PEI) 236
CYCLIC OLEFIN COPOLYMERS (COCs) 237
POLYMER ALLOYS/BLENDS 237
BACKGROUND 237
PPO/HIPS 238
Overview 238
Grades 238
Processing 239
Applications 239
Properties and Advantages 239
PC/ABS 239
Background 239
Trade Named Products 240
Capacities 240
Use in Medical Devices 240
BIOPOLYMERS 241
BIODEGRADABLE POLYMERS 241
Overview 241
Types of Biodegradable Polymers Used in Medical Applications 242
POLYMERS FOR CONTROLLED DELIVERY 243
Background 243
New Developments for Drug Delivery Systems 243
More on Biodegradable Polymers for Medical Implants 244
Important Companies Involved in Biodegradable Polymers for Medical Applications 244
Durect (Pelham, AL) 244
Surmodics (Birmingham, AL) 244
TABLE 107 U.S. MISCELLANEOUS RESINS MARKET BY MEDICAL APPLICATION, THROUGH 2015 (MILLION POUNDS) 245
TABLE 108 U.S. MISCELLANEOUS RESINS MARKET BY NONDISPOSABLE MEDICAL APPLICATION, THROUGH 2015
(MILLION POUNDS) 246
TABLE 109 U.S. MISCELLANEOUS RESINS MARKET BY DISPOSABLE MEDICAL APPLICATION, THROUGH 2015 (MILLION
POUNDS) 246

Chapter-14: PLASTIC MEDICAL DEVICE MOLDERS

BACKGROUND 247
OUTLOOK FOR INJECTION MOLDING OF MEDICAL DEVICES 247
RECENT MEDICAL MOLDER DEVELOPMENTS 248
MACK MOLDING 248



MOLL INDUSTRIES 248
TESSY PLASTICS 248
APEC INDUSTRIES 249
LEADING U.S. MEDICAL INJECTION MOLDERS 249
TABLE 110 LEADING U.S. MEDICAL INJECTION MOLDERS ($ MILLIONS) 249
LEADING MEDICAL FILM AND SHEET MANUFACTURERS 250
TABLE 111 LEADING U.S. MEDICAL FILM AND SHEET MANUFACTURERS ($ MILLIONS) 250
LEADING MEDICAL BLOWMOLDERS 250
TABLE 112 LEADING U.S. MEDICAL BLOWMOLDERS ($ MILLIONS) 250
LEADING U.S. MEDICAL THERMOFORMERS 251
TABLE 113 LEADING U.S. MEDICAL THERMOFORMERS ($ MILLIONS) 251

Chapter-15: MEDICAL RESIN PRODUCERS

TABLE 114 SELECTED RESIN PRODUCERS AND THEIR TRADE NAMED PRODUCTS USED IN MEDICAL DEVICES 252

Chapter-16: SUMMARY OF CURRENT ISSUES IMPACTING THE MEDICAL DEVICE INDUSTRY

MEDICAL DEVICES 254
OVERVIEW 254
UNIQUE DEVICE INDENTIFICATION (UDI) 254
U.S. MEDICAL DEVICE MARKET BENEFITS FROM OUTSOURCING 254
SIGNIFICANT GROWTH EXPECTED IN MEDICAL IMPLANTS 254
MORE AND MORE MEDICAL DEVICE MANUFACTURERS 255
FUTURE GOVERNMENT ESTIMATES ON THE OVERALL HEALTHCARE INDUSTRY 255
AN INTERESTING 2009 VIEW OF THE MEDICAL DEVICE MARKET 255
CHINA'S IMPACT ON THE GLOBAL MEDICAL DEVICE MARKET 256
MEDICAL POLYMER DEVELOPMENTS 256
BACKGROUND 256
PLASTIC BLOOD 256
MEDICAL SUPER PLASTIC 257
PERSONAL TEST DEVICES 257
PLASTIC WRAP KEEPS PREMATURE BABIES WARM 257
SEVERAL LARGE POLYMER COMPANIES ACCELERATE MOVE INTO 'BIOMEDICAL' POLYMERS 257
Solvay 257
DSM 258
BIOCOMPATIBILITY IN POLYMERS CITED IN MEDICAL DEVICE DEVELOPMENT 258
STERILIZATION ISSUES 258
GETTING A PLASTIC MEDICAL DEVICE TO MARKET IS STILL COSTLY AND TIME CONSUMING 259
SMALLER AND MORE COMPACT PLASTIC MEDICAL DEVICES ON THE RISE 259

Chapter-17: COMPANY PROFILES OF KEY SUPPLIERS, PROCESSORS AND COMPOUNDERS OF

ADVANCED POLYMERS 260
ALLERGAN 260
ALPHAGARY CORPORATION 260



APEX MEDICAL TECHNOLOGIES 261
AVAIL MEDICAL PRODUCTS 261
AVERY DENNISON MEDICAL 262
BARD MEDICAL DIVISION (C.R. BARD, INC.) 262
BD MEDICAL-PHARMACEUTICAL SYSTEMS 263
BOEDEKER PLASTICS, INC. 263
B.BRAUN MEDICAL, INC 264
COORS TEK, INC. 264
COVIDIEN 265
DA/PRO RUBBER 265
DUNN INDUSTRIES, INC. 266
ETHOX INTERNATIONAL, INC. 266
FILTERTEK, INC. 267
FLUORTEK, INC. 267
GW PLASTICS 268
GLS THERMOPLASTIC ELASTOMERS 268
W.L. GORE & ASSOCIATES 269
HARMAC MEDICAL PRODUCTS 269
HELIX MEDICAL, INC. 270
INTERNATIONAL POLYMER ENGINEERING 270
MANAN MEDICAL PRODUCTS 270
MEDEGEN, INC. 271
MEDICAL PLASTIC DEVICES, INC. 271
MEDICAL POLYMERS, INC. 272
MEDPLAST, INC. 272
THE MED-TECH GROUP 273
MICROLUMEN, INC. 273
NDH MEDICAL, INC. 274
NEW ENGLAND URETHANE, INC. 274
PRECISION EXTRUSION, INC. 274
PROFESSIONAL PLASTICS 275
PUTNAM PLASTICS COMPANY LLC 275
SAINT GOBAIN PERFORMANCE PLASTICS 276
SPIRE BIOMEDICAL, INC. 276
TELEFLEX MEDICAL 277

Chapter-18: SELECTED KEY ACRONYMS

SELECTED KEY ACRONYMS (CONTINUED) 279
SELECTED KEY ACRONYMS (CONTINUED) 280


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