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 |  موضوع: كتاب Emerging Trends in Medical Plastic Engineering and Manufacturing الجمعة 03 نوفمبر 2023, 11:49 am | |
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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
و المحتوى كما يلي :
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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