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عدد المساهمات : 18928 التقييم : 35294 تاريخ التسجيل : 01/07/2009 الدولة : مصر العمل : مدير منتدى هندسة الإنتاج والتصميم الميكانيكى
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أخواني في الله أحضرت لكم كتاب Emerging Trends in Medical Plastic Engineering and Manufacturing Markus Schönberger Frank Plastic AG, Waldachtal, Germany Marc Hoffstetter MAVIG GmbH, Munich, Germany
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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 Rγ -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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