Emerging Trends in Medical Plastic Engineering and Manufacturing
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Markus Schönberger, Frank Plastic AG, Marc Hoffstetter
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Emerging Trends in Medical Plastic Engineering and Manufacturing
Markus Schönberger
Frank Plastic AG, Waldachtal, Germany
Marc Hoffstetter
MAVIG GmbH, Munich, Germany
Table of contents
Series Pages
About the Authors
Preface
Acknowledgments

  1. Introduction
    1.1. Introduction
    1.2. The Books Target Group
    1.3. User’s Manual
    1.4. Medical Device Engineering—Advantages of Polymers
    1.5. Medical Devices—a Conservative World?
    1.6. Forces behind Future Design and Manufacturing Trends
  2. Regulations for Medical Devices
    2.1. Special Requirements within the Biomedical Field—Fundamentals
    2.2. Biological Demands
    2.3. Legal Demands
    2.4. Regulatory Affairs—Upcoming Restrictions
    2.5. European versus US-Regulations
    2.6. China—The Future Major Regulator?
    2.7. Medical Device Industry Goes Pharma?
  3. Design of Plastic Medical Devices
    3.1. Product Development Process
    3.2. Emerging Influences Plastic Medical Device Design
  4. Generative Manufacturing Technologies—The Future?
    4.1. Fundamentals of 3D Printing
    4.2. Manufacturing of Individual Medical Devices
    4.3. Individual versus Mass Production of Medical Devices
  5. Emerging Manufacturing Technologies
    5.1. Emerging Sterilization Methods
    5.2. Autosterile Manufacturing and Packaging
    5.3. Antimicrobial Device Design
    5.4. Nanomaterials for Medical Devices
    5.5. Miniaturization of Medical Devices
    5.6. Fully Integrated and Automated Device Manufacturing
    5.7. Anticounterfeiting for Medical Devices
  6. Emerging Trends
    6.1. Preventing Reprocessing of Medical Devices
    6.2. IVD Medical Devices
    6.3. LOC Devices
    6.4. Thermoplastic Elastomer the Better Elastomer?
    6.5. Emerging Biopolymer Materials
    6.6. Drug Delivery Devices
    6.7. Health-Related Wearables
  7. Looking through the Crystal Ball
    7.1. Contemporary Medical Device Life Cycle
    7.2. Future Integrated Product Development Processes
    7.3. The Perfect Future Medical Device
    7.4. Future Medical Devices as Part of Smart Living
    7.5. Grand Unified Well-Being1
    Glossary
    Index
    Glossary
    AAL Ambient Assisted Living
    ABR Antibiotic resistance
    AIDC Automatic identification and data capture
    AKF Arburg plastic freeforming
    AMR Antimicrobial resistance
    BRICS Brazil, Russia, India, China, and South Africa
    CAD Computer-aided design
    CAE Computer-aided engineering
    CAI Computer-aided innovation
    CBER Center for Biologics Evaluation and Research
    CDER Center for Drug Evaluation and Research
    CDRH Center for Devices and Radiological Health
    CFDA China Food and Drug Administration
    CNC Computer numerical control
    CNT Carbon nanotube
    D-value Decimal reduction time value
    DLP Digital light processing
    ERP Enterprise recourse planning
    ETO Ethylene oxide
    EUDAMED European Database on Medical Devices
    FDA Food and Drug Administration
    FDM Fused deposition modeling
    GDP Gross domestic product
    GLP Good laboratory practice278 Glossary
    GS1 Global Standards One
    GUDID Global Unique Device Identification Database
    HA Hydroxylapatite
    HAI Health-Associated Infection
    HIBCC Health Industry Business Communications Council
    HRI Human readable interpretation
    ICCBBA International Council for Commonality in Blood Banking
    Automation
    ISO International Organization for Standardization
    IT Information technology
    LED Light-emitting diode
    LOC Lab-on-a-chip
    MAF Master file for devices (technical file/design dossier for FDA
    approval processes)
    MAUDE Manufacturer and User Facility Device Experience
    MDD Medical Device Directive, common name for 93/42/EWG
    MDR Medical Device Regulation
    MJM Multijet modeling
    μTAS Micro total analysis system
    OPC Office for Combination Products
    PDM Product data management
    PEEK Polyetheretherketone
    PMOA Primary mode of action
    QMS Quality management system
    RODAC Replicate Organism Detection and Counting
    ROS Reactive oxygen species
    SCENHIR Scientific Committee on Emerging and Newly Identified
    Health RisksGlossary 279
    SEM Scanning electron microscope
    SLS Selective laser sintering
    STL Stereolithography (language)
    SWOT Strengths, weakness, opportunities, and threats
    TC Technical Committee (of ISO)
    TIPS see TRIZ for explanation
    TRIZ A Russian acronym for “Teoria reschenija isobretatjelskich
    sadatsch,” which is regularly translated to “Theory of Inventive Problem Solving” (TIPS)
    UMDNS Universal Medical Device Nomenclature System
    UV Ultraviolet radiation281
    Index
    A
    Acquiring geometric data, 112–114
    Additives, 81–82
    Aggressive ambient media, 83
    Ambient assisted living (AAL), 216–218
    Antibiotic resistance (ABR), 242
    Antimicrobial device design
    antibiotic resistance, 189–190
    antimicrobial coatings, 196–198,
    196f–197f
    antimicrobial compounds, 193f
    antimicrobial modified resins,
    195–196
    colloidal silver, 193–194
    finely dispersed particles, 193–194
    photocatalytic reactions, 194–195
    reactive oxygen species, 194–195
    titanium dioxide, 194–195, 195f
    antimicrobial monomers, 191–192, 192f
    antimicrobial resistance, 189–190
    antimicrobial surfaces, 190–191, 191f
    health associated infection (HAI), 190
    ideal approach, 198
    implant infection, 189–190
    urinary catheters, 189–190
    Antimicrobial monomers, 191–192, 192f
    Antimicrobial resistance (AMR), 189–190
    Antimicrobial surfaces, 190–191, 191f
    Application optimized devices, 138, 139f
    Arburg plastic freeforming (AKF),
    125–127, 127f
    Artificial DNA, 231–233, 232f
    Artificial heart valve, 257–258, 258f
    As low as reasonably practicable
    (ALARP), 40
    Assembly injection molding, 212–213
    Automated flying drone, 16–17, 17f
    Autosterile manufacturing/packaging
    aseptic production, 184
    blow-fill-and-seal-technology, 187–189
    effects and development potential, 187,
    188t
    ethylene oxide, 183
    Geobacillus stearothermophilus,
    187–189
    GMP-A level, 187–189
    hygienic regulations and standards,
    184, 185t
    ISO 13408, 187–189
    medical single-use products, 184, 186f
    γ-radiation, 183
    B
    Biocompatibility, 26, 26f
    Biodegradable polymers, 252f
    bulk erosion, 251–252
    polyanhydrides, 253
    polycaprolactone (PCL), 253
    polyglycolide (PGA), 252
    polylactic acid (PLA), 253
    polylactic-co-glycolid (PLGA),
    253–255
    surface erosion, 251–252
    Biopolymer materials, 251
    biodegradable polymers, 252f
    bulk erosion, 251–252
    polyanhydrides, 253
    polycaprolactone (PCL), 253
    polyglycolide (PGA), 252
    polylactic acid (PLA), 253
    polylactic-co-glycolid (PLGA),
    253–255
    surface erosion, 251–252
    engineering, 257–260
    shape-memory polymers (SMPs),
    255–256
    Bioresorbable electronic stent (BES),
    209–210, 210f
    Bisphenol-A, 15–16
    Blow-fill-and-seal-technology, 187–189
    Note: ‘Page numbers followed by “f” indicate figures and “t” indicate tables.’282 Index
    Bonded joint technology, 172
    Bone cement, 200–201
    Boron neutron capture therapy (BNCT), 202
    Bovine spongiform encephalopathy
    (BSE), 237
    C
    21 CFR part 11, 44–45
    Chemical vapor deposition, 196–197
    Chinese Food and Drug Administration
    (CFDA), 58–59
    CliniCloud, 265–266, 267f
    Colloidal silver, 193–194
    Colony forming units (CFUs), 32–33
    Complex three-dimensional (3D)
    geometries, 114, 115f
    Contemporary product development
    process, 269–271, 270f
    Continuous glucose monitoring, 219f,
    221f–222f
    artificial pancreas, 220–221
    automated and continuous
    measurement, 220–221
    finger prick, 219–220
    insulin, 218–219
    prevalence, diabetes, 218
    primary benefit of therapy, 221–222
    secondary benefit of therapy, 221–222
    Cyborg, 262–263
    D
    Dalkon Shield, 12
    Digital light projection (DLP), 121–122,
    121f
    Drug delivery devices, 260–262
    E
    Electron-beam sterilization, 182, 183f
    Emerging sterilization methods
    definition, 178–179
    D-value, 178–179
    emerging technologies, 182–183
    environmental issues, 181–182
    Geobacillus stearothermophilus, 178–179
    injection molding/extrusion, 180
    material issues, 181
    single-use and reusable devices, 178, 179t
    Endotoxins, 25, 25f
    Ethylene oxide (EO), 181–182
    EU medical device directive (MDD), 49–51
    EU medical device regulation (MDR),
    49–51
    Extractables, 22–23
    Extrusion principle, 86–87, 87f
    F
    Finely dispersed particles, 193–194
    Foreign body reactions
    endotoxins, 25
    path of access for a Life Science
    product, 23, 24t
    pyrogens, 25
    Fused deposition modeling (FDM),
    124–125, 125f
    Future integrated product development
    processes, 271–273, 272f
    G
    Generative manufacturing technologies
    3D printing. See also Three-dimensional
    (3D) printing
    approaches, 117, 119t
    Arburg plastic freeforming, 125–127,
    127f
    digital light projection, 121–122, 121f
    fused deposition modeling, 124–125,
    125f
    multijet modeling, 122–123, 122f
    razor-blade business model, 118
    selective laser sintering, 123–124, 124f
    stereolithography, 118–121, 120f
    individual medical devices
    approval process, 143–144
    current applications, 144–152
    emerging design and technical
    challenges, 153–160
    legal challenges, 160–162
    vs. mass production, 162–174
    Geobacillus stearothermophilus, 178–179
    Grand Unified Well-being, 275–276, 276f
    H
    Healthcare-associated infection (HAI), 190
    Health-related wearables
    CliniCloud, 265–266, 267f
    cyborg, 262–263Index 283
    LOHAS, 265
    Metria™ IH1, 265, 266f
    robotic system HAL I, 263–264, 264f
    Steven Mann, 262–263, 263f
    I
    Import Medical Device Registration
    Certificate (IMDRC), 58–59
    Individual medical devices
    approval process, 143–144
    current applications, 144–145
    device production, 145–147
    manual treatment planning, 145–147
    surgical treatments, 147–148
    virtual planned 3D-printed devices,
    149–152
    emerging design and technical
    challenges, 153–155
    3D-printer and hygienic design,
    157–158
    hygienic handling, 158–160
    liable planning, 160
    material selection, 156
    process chain, 160
    process stability, 158–160
    testing, 156–157
    treatment options vs. market volume,
    153–154
    legal challenges, 160–162
    vs. mass production, 162–163
    restriction, 166–168
    standard mass production, 164–166
    unification, 168–174
    Injection molding/extrusion, 86–87, 180,
    88f, 180f
    Innovative problem-solving methods,
    99–100
    open innovation, 103–105
    TRITZ methods, 103, 104f
    TRIZ-theory
    overview, 103
    patents and technical documents, 100
    solution path, 101–102, 102f
    Integrated/automated device
    manufacturing
    automated sensor integration
    ambient assisted living, 216–218
    bedside lamp, 215, 215f
    blood sugar level, 214–215, 216f
    inlay molding, 215
    single-use sensors/electronics,
    214–215
    autosterile manufacturing, 211–212
    continuous glucose monitoring, 219f,
    221f–222f
    artificial pancreas, 220–221
    automated and continuous
    measurement, 220–221
    finger prick, 219–220
    insulin, 218–219
    prevalence, diabetes, 218
    primary benefit of therapy, 221–222
    secondary benefit of therapy, 221–222
    Luer-Lock, 211–212
    mechanical assembly
    assembly injection molding, 212–213
    multicomponent injection molding,
    212–213
    tooth brushes, 212–213, 212f
    International Medical Products AntiCounterfeiting Taskforce
    (IMPACT), 222–223
    International Organization for
    Standardization (ISO)
    ISO 10993, 33–34, 46, 81–82
    animal welfare, 47–48
    biocompatibility testing, 46
    design, 34–35
    ISO 10993-2, 47–48
    ISO 10993-5, 35–37
    ISO 10993-10, 35–37
    nanomaterials, 48
    process, 34–35, 34f
    respiratory devices, 48
    specific issues, 47
    technical committee, 47
    tested materials, 35–37
    ISO 13485, 48–49, 69, 90
    ISO 14971, 39–41, 78–79
    Invisible tagging, 230–231
    In vitro diagnostics (IVDs), 62–64, 63f
    antibiotic resistance, 242
    definition, 240–241
    fully automated PCR desktop-analysis,
    243–244
    PCR, 242, 243f284 Index
    K
    Kinegram®, 225–226
    L
    Lab-on-a-chip (LOC) devices
    complex micro/nanofluidic systems,
    244–245
    inkjet technology, 246–248, 247f
    low-cost lab-on-a-chip devices,
    245–246, 247f
    microfluidics, 244
    micro total analysis systems (μTAS),
    244
    monocyte activation test (MAT), 246
    Leachables, 22–23
    Life style of health and sustainability
    (LOHAS), 265
    Lightweight construction and medical
    devices, 140–141
    Limulus amebocyte lysate (LAL), 31
    Lotus effect, 190–191
    Luer-Lock, 211–212
    M
    Manufacturer and User Facility Device
    Experience (MAUDE), 98–99
    Materials selection
    biological aspects
    biocompatibility, 83
    designated market, 84
    material stability, 84
    positive biological evaluation, 83
    commercial aspects, 85–86
    definition, 82
    regulatory aspects, 84, 85f
    technical aspects, 83
    Mechanical bonding, 172–174
    Medical devices, 273–275
    anticounterfeiting
    apparent visible security label, 233
    artificial DNA, 231–233, 232f
    dot matrix, 225–226
    embed holographic effects, 226–227
    holograms, 225–226
    IMPACT, 222–223
    invisible tagging, 230–231, 234
    kinetic images, 225–226
    RFID, 229–230
    security printing, 224–225, 224f
    special inks/intaglio, 224–225, 224f
    surface structuring, 227–228, 228f
    true color holograms, 225–226
    complexity, 11–12
    consumer markets, 16–18
    contemporary product development
    process, 269–271, 270f
    cost reduction, 14–15
    demographic trend, 14–15
    engineering developments, 16–18
    future design, 14–18
    future integrated product development
    processes, 271–273, 272f
    health insurance systems, 15
    legal and ethical liability, 12
    legislative measures, 15–16
    manufacturing, 2–3, 14–18
    medical work environment, 12–13
    miniaturization, 207f
    bioresorbable electronic stent,
    209–210, 210f
    extrusion, 205–206
    heart support system, 208–209, 209f
    injection molding, 206–208
    interventional therapies, 205–206
    lotus effect, 204
    Moore’s Law, 204
    multilumen microtubing, 205–206,
    206f
    novel middle ear implant, 208, 209f
    surface structures, 206–208
    nanomaterials, 198–199
    antimicrobial modification, 199
    dentistry, 200
    enhanced biointegration, 201–204
    reinforcement, 200–201
    surface modification, 200
    polymers, advantages, 8–11
    profit margin vs. innovations, 13
    regulatory efforts, 15–16
    reprocessing prevention, 236
    reusable medical devices, 236–237
    SUDs
    laser systems, 238–239
    prefilled syringe, 239–240, 240f
    reprocessing, 237–238
    ultrasonic scanners, 238–239Index 285
    Medical Device Single Audit Program
    (MDSAP), 38
    Medical grade, 2–3
    Metria™ IH1, 265, 266f
    Micro color codes, 230
    Microfluidics, 244
    Micro total analysis systems (μTAS), 244
    Molecular tagging, 230–231
    Monocyte activation test (MAT), 31
    Moore’s Law, 204
    Multicomponent injection molding,
    212–213
    Multijet modeling (MJM), 122–123, 122f
    Munich Procedure Model, 73
    N
    Natural rubber, 248–249
    O
    Ozurdex® drug delivery system, 261–262,
    262f
    P
    Parylene, 196–197
    Patient individualized medical devices,
    138
    Pharmacopeia of the United States (USP),
    29–30, 30f
    Plastic 3D-printing, 117t
    Plastic medical device design
    complex design validation and
    verification, 97–99
    cost and time reduction
    device design, 94
    error margin reduction, 94
    vascular implant company, 93–94
    design changes, 91
    design transfer, 89–91
    employee education and liability
    factors, 95–96
    high volatile end-consumer markets,
    91–92
    individualization, 96–97
    innovative problem-solving methods,
    99–105
    master file for devices, 67
    methodical approaches
    decision-making, 77–78
    identifying solution ideas, 75–76
    Munich Procedure Model, 73
    objective achievement protection,
    78–79
    objective analyses, 74–75
    objective planning, 73–74
    problem structuring, 75
    properties determination, 76–77
    quality and risk management, 69–73
    style format, 68–69, 68t
    risk analysis, 65–66
    safeguarding, quality and risk
    management tools, 89
    specific requirements
    additives, 81–82
    adequate change policy, 80–81
    biocompatibility evaluation, 81
    disinfectant and sterilization agent, 82
    extrusion principle, 86–87, 87f
    injection molding principle, 86–87,
    88f
    long-term market availability, 80–81
    materials selection, 82–86
    medical grade, 80
    patient and operator protection,
    79–80
    unobjectionable ingredients usage,
    81–82
    technical file/design dossier, 67
    Point-of-care testing (POCT), 63, 63f
    Polyanhydrides, 253
    Polycaprolactone (PCL), 253
    Polyetheretherketone (PEEK), 82, 181
    Polyglycolic acid (PGA), 252
    Polylactic acid (PLA), 253
    Polylactic-co-glycolic acid (PLGA),
    253–255
    Polymerase chain reaction (PCR), 242
    Polymerize antimicrobial monomers,
    191–192
    Polymers, 22, 22f
    Prefilled syringe, 239–240, 240f
    Printing individualization, 170f
    actual bonding, 169–170
    advantages, 170
    disadvantages, 171
    Process validation, 44f
    Pyrogens, 25, 25f286 Index

    -Radiation, 181–182
    Radioactive cobalt-60 isotopes, 181–182
    Radio-frequency identification (RFID),
    229–230
    Rapid diagnostic tests (RDTs), 63, 63f
    RapidNAM technology, 151–152
    Rapid prototyping, 128–129
    Rapid tooling, 141–142, 142f
    Reactive oxygen species (ROS), 194–195
    Regulations, medical devices. See also
    Medical devices
    biological demands, 29f
    biocompatibility, 26
    biological safety, 27
    shape and surface, 28
    surface-area-to-volume ratio, 28
    toxicity, 26–27, 27f
    China, 58–60
    combination products, 61–62
    European vs. US-regulations
    global harmonization, 55–58
    market structures and potentials, 53–54
    process of approval, 54–55, 56f
    extractables, 22–23
    foreign body reactions
    endotoxins, 25
    path of access for a Life Science
    product, 23, 24t
    pyrogens, 25
    IVDs, 62–64, 63f
    leachables, 22–23
    legal demands
    21 CFR part 11, 44–45
    colony forming units, 32–33
    ISO 10993, 33–37
    limulus amebocyte lysate (LAL), 31
    Pharmacopeia of the United States
    (USP), 29–30
    quality management systems (QMS),
    29, 38
    risk management, 39–41
    standards and regulations, 37–38
    validation, 41–44
    regulatory affairs
    EU medical device directive (MDD),
    49–51
    global harmonization, 45–46
    ISO 10993, 46–48
    ISO 13485, 48–49
    Unique device identifier (UDI)
    system, 51–53
    regulatory issues, 60, 61f
    special requirements, 21–25
    Regulatory affairs, 3–4
    EU medical device directive (MDD),
    49–51
    global harmonization, 45–46
    ISO 10993, 46–48
    ISO 13485, 48–49
    Unique device identifier (UDI) system,
    51–53
    S
    Selective internal radiation therapy, 202
    Selective laser sintering (SLS), 123–124,
    124f
    Shape-memory polymers (SMPs),
    255–256, 256f
    Single-use devices (SUDs), 180, 236–237
    laser systems, 238–239
    prefilled syringe, 239–240, 240f
    reprocessing, 237–238
    ultrasonic scanners, 238–239
    Standard mass production, 164–166
    Stereolithography (STL) technology, 114
    development, 118
    procedural principle, 118, 120f
    Styrene-butadiene rubber, 248–249
    T
    Thermoplastic elastomers (TPEs)
    injection molding of liquid silicone
    rubber, 249
    natural rubber, 248–249
    silicone materials, 249
    styrene-butadiene rubber, 248–249
    Three-dimensional (3D) printing
    acquiring geometric data, 112–114
    displacement procedure, 110–111
    generative manufacturing technologies
    approaches, 117, 119t
    Arburg plastic freeforming, 125–127,
    127f
    digital light projection, 121–122, 121f
    fused deposition modeling, 124–125,
    125f
    multijet modeling, 122–123, 122fIndex 287
    razor-blade business model, 118
    selective laser sintering, 123–124,
    124f
    stereolithography, 118–121, 120f
    individualized standard devices,
    110–111
    opportunities, 133
    application optimized devices, 138,
    139f
    complex geometrical design,
    136–137
    cost reduction opportunities,
    134–136
    for engineers, 133–134
    ideality, 137–138
    lightweight construction and medical
    devices, 140–141
    patient individualized medical
    devices, 138
    rapid tooling, 141–142, 142f
    tissue optimized medical devices,
    139–140
    preprocessing geometric data, 114–116,
    115f
    printing machine preparation, 116
    printing sequence, 116
    qualitative analysis, 109, 110f
    rapid manufacturing technologies, 112,
    113f
    trends and potential, 127
    general trends and potential,
    128–130
    improvement potential, 131–133
    Tissue engineering, 257–258
    Tissue optimized medical devices,
    139–140
    U
    Unique Device Identifier (UDI), 51–53,
    52f
    Urinary catheters, 189–190
    V
    Validation, 44f
    Virtual planned 3D-printed devices
    aligner principle, 151
    incremental aligner device, 149–151,
    150f
    RapidNAM technology, 151–152
    virtual planned nasoalveolar molding
    devices, 151–152, 152f
    W
    Welding, 171–172

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