Medical device design: innovation from concept to market

Front Cover......Page 1
Medical Device Design......Page 4
Copyright Page......Page 5
Contents......Page 8
Preface......Page 16
Acknowledgements......Page 18
1.1 What Is Design?......Page 20
1.2 The Design Life Cycle......Page 23
1.3 Medical Devices Definitions......Page 24
References......Page 28
2.2 Classification Rules......Page 30
2.3 Classification Case Study......Page 32
2.3.1 EU Classification......Page 33
2.3.2 USA Classification......Page 36
2.3.3 Special Cases......Page 40
2.4 Classification Models......Page 41
2.5 Classification and the Design Process......Page 42
2.6 Summary......Page 44
References......Page 45
3.1 Design Process versus Design Control......Page 46
3.2 Design Models......Page 48
3.2.1 Pahl and Beitz, and Pugh......Page 49
3.2.2 Divergent–Convergent Model......Page 51
3.3 Managing Design......Page 57
3.3.1.1 Serial Design......Page 58
3.3.1.2 Ad Hoc Feedback......Page 59
3.3.1.3 Concurrent Design/Concurrent Engineering......Page 60
3.3.1.4 Collaborative Models......Page 63
3.3.1.5 Holistic Models......Page 65
3.3.1.6 Which Model Is Best for Me?......Page 66
3.4 Cross-Reference with Regulatory Requirements......Page 67
3.5 Summary......Page 69
Further Reading......Page 70
4.1 Introduction......Page 72
4.3 Overall Procedure......Page 73
4.4 Audit /Review Procedure......Page 76
4.5 The Design Process......Page 80
4.5.1 New Product Procedure......Page 81
4.5.2 Clarification/Product Specification Procedure......Page 82
4.5.4 Design Verification/Validation/Evaluation Procedure......Page 84
4.5.5 Design Changes......Page 85
4.6 Implementing a Procedure......Page 87
References......Page 89
5.2 Developing the Statement of Need (or Brief)......Page 90
5.2.2 Formalizing the Statement of Need......Page 91
5.3.1 Essential Elements of a PDS......Page 94
5.3.1.2 Regulatory and Statutory......Page 97
5.3.1.3 Technical......Page 98
5.3.1.4 Performance......Page 99
5.3.1.4.1 Biomechanics......Page 100
5.3.1.6 Manufacturing......Page 102
5.3.1.7 Packaging and Transportation......Page 103
5.3.1.8 Environmental......Page 105
5.4.1 Focus Groups......Page 106
5.4.3 Immersion......Page 109
5.4.4.2 Journals and Learned Publications......Page 110
5.4.4.3 Books......Page 111
5.4.7 Conferences and Symposia......Page 112
5.4.8 Others......Page 113
5.5 Summary......Page 119
References......Page 120
6.2 The “Engineer’s Notebook”......Page 122
6.3.1 The White Room......Page 123
6.3.2 Personal Space......Page 124
6.4 Generating Concepts/Ideas......Page 125
6.4.1 Radial Thinking......Page 126
6.4.2 Inversion (or Word Association)......Page 127
6.4.3 Analogue......Page 128
6.4.5 Discretizing......Page 129
6.4.6 Morphological Analysis......Page 130
6.4.8 We Have Ideas!......Page 131
6.5.2 Criteria Assessment......Page 132
6.5.3 Weighted Criteria Assessment......Page 134
6.6 Summary......Page 136
References......Page 137
7.2 Optimization......Page 138
7.3 Design of Experiments/2k Factorial Experiments......Page 143
7.4 House of Quality......Page 150
7.5 Failure Mode and Effect Analysis (FMEA)......Page 153
7.5.1 Fault Tree Analysis......Page 162
7.5.1.1 Ishikawa Diagram......Page 167
7.7 Six Sigma......Page 168
7.8 Summary......Page 169
References......Page 170
8.2 The Process to Design Realization......Page 172
8.2.6 How?......Page 173
8.3 Assemble Your Detailed Design Team......Page 174
8.3.2 Phases of a Team......Page 175
8.4 Design Calculations......Page 177
8.4.1 Computer-Aided Analysis......Page 179
8.4.2 Computer-Aided Analysis Disciplines......Page 180
8.5 Materials Selection......Page 181
8.5.3 Precedent......Page 183
8.5.4 Research......Page 184
8.5.6 Standards......Page 185
8.5.7 Materials Search Engines......Page 186
8.5.10 Animal Products......Page 189
8.5.11.2 Definition(s) and Standards......Page 190
8.6 Computer-Aided Design......Page 191
8.6.1 Cloud Computing......Page 193
8.6.3 Collaboration......Page 194
8.6.5 Engineering Drawings......Page 195
8.6.6 Part Numbering......Page 198
8.6.8 Sign Off......Page 199
8.6.10 3D Visualization......Page 200
8.7 D4X......Page 201
8.7.1 Design for Manufacture (DFM)......Page 202
8.7.2 Design for Assembly (DFA)......Page 206
\n8.7.4 Design for Sterilization (DFS)......Page 209
8.7.5 Design for Environment/Sustainability (DFE)......Page 210
8.8 Design for Usability (DFU)......Page 213
8.8.1 Ergonomics......Page 215
8.8.2 Man-Machine Interface......Page 216
8.8.3 Design for Desirability......Page 217
References......Page 218
9.1.1 Clinical Trial or Clinical Evaluation: What Is the Difference?......Page 220
9.1.4 Relationship with the PDS......Page 221
9.2 Risk Analysis......Page 222
9.2.1 Identifying Risks/Hazards......Page 223
9.2.2 Assessing Level of Risk......Page 227
9.3 Criteria-Based Evaluation......Page 233
9.3.2 Accelerated Life Tests......Page 235
9.3.2.2 Cyclic Loading......Page 236
9.3.2.4 Humidity and Temperature......Page 237
9.3.2.5 Normal Use......Page 238
9.3.3 Calibration......Page 239
9.3.3.3 Repeatability......Page 240
9.3.3.5 Resolution......Page 241
9.3.3.7 Summary of Calibration......Page 242
9.3.4 Surface Evaluation......Page 243
9.3.4.1 USB Microscopes......Page 244
9.3.4.4 Hardness Testing Machines......Page 245
9.3.4.7 Beam Profile Reflectometry (BPR)......Page 247
9.4.2 Dynamic Simulation......Page 248
9.5 Value to “Healthcare” Analysis......Page 249
9.5.1 Distinct Health Benefits......Page 250
9.5.2 Stating Clinical Benefits......Page 252
9.6.1 The Hypothesis......Page 253
9.6.2 Investigation Specification......Page 255
9.6.2.1 Study Types......Page 258
9.6.4 Relationship with Regulatory Bodies......Page 260
9.6.5 ISO 14155 and EC–FDA Guidelines......Page 261
9.6.6.2 Correlation......Page 262
9.6.6.3 Averages and Confidence Limits......Page 264
9.6.6.4 The Student t-test......Page 265
9.7 Literature Review......Page 267
9.7.1 Conducting the Review......Page 268
9.7.2 Format for Literature Review......Page 269
9.8 Format for Formal Clinical Evaluation Report......Page 271
References......Page 272
10.2 Identifying Potential Suppliers......Page 274
10.2.1 Samples......Page 275
10.2.3 Contractual Arrangements......Page 276
10.3 Packaging......Page 277
10.3.1 Sterile Packaging......Page 278
10.3.2 Nonsterile Packaging......Page 280
10.3.3 Packaging Testing......Page 281
10.3.4 Storage Considerations......Page 282
10.4 Procurement......Page 284
10.4.2 Costing......Page 285
Further Reading......Page 286
11.1.1 The Rules......Page 288
11.2.3 Single Use Item......Page 290
11.2.7 Catalog Number/Part Number......Page 291
11.2.9 Prescription Only......Page 292
11.2.12 EC Representative......Page 293
11.3.1 Outer Packaging Labels......Page 294
11.3.3 Bar Codes......Page 295
11.3.5 Crossover of Symbols between USA and EC......Page 296
11.4.1 Company Identification Mark......Page 297
11.5 IFUs and Surgical Techniques......Page 298
11.6 Surgical Technique......Page 299
11.6.2 Warnings and Contraindications......Page 301
11.7.1 Declaration of Conformity......Page 302
11.8 Translation......Page 303
References......Page 304
12.1 Introduction......Page 306
12.3.1 Process Control Chart......Page 307
12.3.2 Reliability – Bathtub Curve......Page 309
12.3.3 Weibull Plot......Page 310
12.3.4 Measles Chart......Page 313
12.4.1 Early Adopters and Key Opinion Leaders......Page 314
12.4.2 Focus Groups......Page 315
12.6 The Good, the Bad, and the Ugly......Page 316
Further Reading......Page 317
13.1 Introduction......Page 318
13.2.1 Patent......Page 319
13.2.1.1 Filing......Page 320
13.2.1.2 Examination......Page 321
13.2.1.3 Other Countries......Page 322
13.3 Keeping Mum......Page 323
13.5 Summary......Page 325
References......Page 326
14.2.1 EC Application......Page 328
14.2.2 FDA Registration......Page 330
14.4 FDA Process......Page 332
14.4.1 Substantial Equivalence (SE)......Page 334
14.4.3 Process......Page 335
14.5.1 Advice......Page 336
14.5.5 Stock Control......Page 337
14.6.1 Unique Selling Points (USP)......Page 338
14.6.5 Insurance......Page 339
References......Page 340
FDA Medical Devices......Page 342
Appendix B: Tables......Page 344
Appendix C: ISO 14971 Annex C Pre–Risk Analysis Questionnaire......Page 346
Appendix D: Generic Codes for Class I Medical Devices (MHRA)......Page 352
FDA Class I and II Exempt Devices......Page 356
E.2 Stress and Strain......Page 358
Index......Page 362