Medical device design for six SIGMA : a road map for safety and effectiveness

Medical Device Design for Six Sigma: A Road Map for Safety and Effectiveness presents the complete body of knowledge for Design for Six Sigma (DFSS), as outlined by American Society for Quality, and details how to integrate appropriate design methodologies up front in the design process. DFSS helps companies shorten lead times, cut development and manufacturing costs, lower total life-cycle cost, and improve the quality of the medical devices. Comprehensive and complete with real-world examples, this guide:

Integrates concept and design methods such as Pugh Controlled Convergence approach, QFD methodology, parameter optimization techniques like Design of Experiment (DOE), Taguchi Robust Design method, Failure Mode and Effects Analysis (FMEA), Design for X, Multi-Level Hierarchical Design methodology, and Response Surface methodology

Covers contemporary and emerging design methods, including Axiomatic Design Principles, Theory of Inventive Problem Solving (TRIZ), and Tolerance Design

Provides a detailed, step-by-step implementation process for each DFSS tool included

Covers the structural, organizational, and technical deployment of DFSS within the medical device industry

Includes a DFSS case study describing the development of a new device

Presents a global prospective of medical device regulations

Providing both a road map and a toolbox, this is a hands-on reference for medical device product development practitioners, product/service development engineers and architects, DFSS and Six Sigma trainees and trainers, middle management, engineering team leaders, quality engineers and quality consultants, and graduate students in biomedical engineering.

Author Notes

Basem S. El-Haik, PhD, is the CEO and President of Six Sigma Professionals, Inc. (www.sixsigmapi.com) in Canton, Michigan, and the author of many bestselling books on Design for Six Sigma. Dr. El-Haik is well known in the DFSS domain and has been a featured speaker at many technical conferences. He has seventeen years of experience in contemporary design and quality engineering methods and has trained, certified, coached, and monitored over 600 belts (Green Belts, Black Belts, and Master Belts) in DFSS and Six Sigma in both tracks: product and service (transactional). basem.haik@sixsigmapi.com

Khalid S. Mekki is a Quality Manager at Baxter Healthcare Corporation, where he has served in various capacities since 2001. He is working toward his PhD in industrial engineering at the University of Illinois at Chicago. Khalid holds a master's degree in mechanical/quality engineering and a bachelor's degree in mechanical engineering. He has led and completed numerous Design for Six Sigma projects.

Foreword	p. xvii
Preface	p. xix
1 Medical Device Design Quality	p. 1
1.1 Introduction	p. 1
1.2 The Essence of Quality	p. 2
1.3 Quality Operating System and the Device Life Cycle	p. 5
1.3.1 Stage 1: Idea Creation	p. 6
1.3.2 Stage 2: Voice of the Customer and Business	p. 7
1.3.3 Stage 3: Concept Development	p. 8
1.3.4 Stage 4: Preliminary Design	p. 9
1.3.5 Stage 5: Design Optimization	p. 9
1.3.6 Stage 6: Verification and Validation	p. 9
1.3.7 Stage 7: Launch Readiness	p. 10
1.3.8 Stage 8: Mass Production	p. 10
1.3.9 Stage 9: Consumption	p. 11
1.3.10 Stage 10: Disposal or Phaseout	p. 11
1.4 Evolution of Quality	p. 11
1.4.1 Statistical Analysis and Control	p. 12
1.4.2 Root-Cause Analysis	p. 13
1.4.3 Total Quality Management	p. 13
1.4.4 Design Quality	p. 14
1.4.5 Process Simplification	p. 15
1.4.6 Six Sigma and Design for Six Sigma	p. 15
1.5 Business Excellence: A Value Proposition	p. 17
1.5.1 Business Operation Model	p. 17
1.5.2 Structure of the Medical Device Quality Function	p. 18
1.5.3 Quality and Cost	p. 22
1.5.4 Quality and Time to Market	p. 23
1.6 Summary	p. 23
2 Design for Six Sigma and Medical Device Regulation	p. 25
2.1 Introduction	p. 25
2.2 Global Perspective on Medical Device Regulations	p. 25
2.3 Medical Device Classification	p. 28
2.4 Medical Device Safety	p. 29
2.5 Medical Device Quality Management Systems Requirements	p. 31
2.6 Medical Device Regulation Throughout the Product Development Life Cycle	p. 34
2.6.1 Design and Development Plan	p. 36
2.6.2 Design Input	p. 42
2.6.3 Design Output	p. 44
2.6.4 Design Review	p. 46
2.6.5 Design Verification and Validation	p. 47
2.6.6 Design Transfer	p. 49
2.6.7 Design Changes	p. 50
2.6.8 Design History File	p. 50
2.6.9 QSIT Design Control Inspectional Objectives	p. 51
2.7 Summary	p. 52
3 Basic Statistics	p. 53
3.1 Introduction	p. 53
3.2 Common Probability Distributions	p. 53
3.3 Methods of Input and Output Analysis	p. 56
3.4 Descriptive Statistics	p. 58
3.4.1 Measures of Central Tendency	p. 59
3.4.2 Measures of Dispersion	p. 61
3.5 Inferential Statistics	p. 63
3.5.1 Parameter Estimation	p. 63
3.5.2 Hypothesis Testing	p. 65
3.5.3 Experimental Design	p. 69
3.6 Normal Distribution and Normality Assumption	p. 70
3.6.1 Violating the Normality Assumption	p. 72
3.7 Summary	p. 72
4 The Six Sigma Process	p. 73
4.1 Introduction	p. 73
4.2 Six Sigma Fundamentals	p. 73
4.3 Process Modeling	p. 74
4.3.1 Process Mapping	p. 74
4.3.2 Value Stream Mapping	p. 75
4.4 Business Process Management	p. 76
4.5 Measurement Systems Analysis	p. 77
4.6 Process Capability and Six Sigma Process Performance	p. 78
4.6.1 Motorola's Six Sigma Quality	p. 82
4.7 Overview of Six Sigma Improvement	p. 84
4.7.1 Phase 1: Define	p. 84
4.7.2 Phase 2: Measure	p. 84
4.7.3 Phase 3: Analyze	p. 85
4.7.4 Phase 4: Improve	p. 85
4.7.5 Phase 5: Control	p. 85
4.8 Six Sigma Gose Upstream: Design for Six Sigma	p. 86
4.9 Summary	p. 86
Appendix 4A Cause-and-Effect Tools	p. 87
5 Medical Device Design for Six Sigma	p. 89
5.1 Introduction	p. 89
5.2 Value of Designing for Six Sigma	p. 91
5.3 Medical Device DFSS Fundamentals	p. 94
5.4 The ICOV Process in Design	p. 96
5.5 The ICOV Process in Product Development	p. 98
5.6 Summary	p. 100
6 Medical Device DFSS Deployment	p. 101
6.1 Introduction	p. 101
6.2 Medical Device DFSS Deployment Fundamentals	p. 102
6.3 Predeployment Phase	p. 103
6.3.1 Predeployment Considerations	p. 105
6.4 Deployment Phase	p. 125
6.4.1 Training	p. 126
6.4.2 Project Financials	p. 127
6.5 Postdeployment Phase	p. 128
6.6 DFSS Sustainability Factors	p. 129
6.7 Black Belts and the DFSS Team: Cultural Change	p. 132
6.8 Summary	p. 135
7 Medical Device DFSS Project Road Map	p. 137
7.1 Introduction	p. 137
7.2 Medical Device DFSS Team	p. 139
7.3 Medical Device DFSS Road Map	p. 143
7.3.1 Phase 1: Identify Requirements	p. 144
7.3.2 Phase 2: Characterize Design	p. 148
7.3.3 Phase 3: Optimize Requirements	p. 151
7.3.4 Phase 4: Verify/Validate the Design	p. 152
7.4 Software DFSS ICOV Process	p. 154
7.5 Summary	p. 157
8 Quality Function Deployment	p. 159
8.1 Introduction	p. 159
8.2 History of QFD	p. 160
8.3 QFD Fundamentals	p. 161
8.4 QFD Methodology	p. 161
8.5 HQQ Evaluation	p. 164
8.6 HQQ 1: The Customer's House	p. 165
8.6.1 Kano Model	p. 167
8.7 HQQ 2: Translation House	p. 170
8.8 HQQ 3: Design House	p. 171
8.9 HQQ 4: Process House	p. 171
8.10 Application: Auto 3D	p. 172
8.11 Summary	p. 175
9 DFSS Axiomatic Design Method	p. 177
9.1 Introduction	p. 177
9.2 Axiomatic Method Fundamentals	p. 179
9.3 Introduction to Axiom 1	p. 183
9.4 Introduction to Axiom 2	p. 185
9.5 Axiomatic Design Theorems and Corollaries	p. 189
9.6 Application: Medication Mixing Machine	p. 192
9.7 Application: Axiomatic Design Applied to Design Controls	p. 193
9.8 Summary	p. 196
Appendix 9A Matrix Review	p. 196
10 DFSS Innovation for Medical Devices	p. 198
10.1 Introduction	p. 198
10.2 History of the Theory of Inventive Problem Solving	p. 198
10.3 TRIZ Fundamentals	p. 200
10.3.1 Overview	p. 200
10.3.2 Analytical Tools	p. 204
10.3.3 Knowledge-Based Tools	p. 204
10.4 TRIZ Problem-Solving Process	p. 209
10.5 Ideal Final Result	p. 210
10.5.1 Itself Method	p. 210
10.5.2 Ideality Checklist	p. 211
10.5.3 Ideality Equation	p. 211
10.6 Building Sufficient Functions	p. 212
10.7 Eliminating Harmful Functions	p. 212
10.8 Inventive Principles	p. 213
10.9 Detection and Measurement Concepts	p. 219
10.10 TRIZ Root Cause Analysis	p. 220
10.11 Evolution trends in Technological Systems	p. 221
10.12 TRIZ Functional Analysis and Analogy	p. 224
10.13 Application: Using Triads to Predict and Conceive Next-Generation Products	p. 225
10.14 Summary	p. 234
Appendix 10A Contradiction Matrix	p. 234
11 DFSS Risk Management Process	p. 240
11.1 Introduction	p. 240
11.2 Planning for Risk Management Activities in Design and Development	p. 241
11.3 Risk Assessment Techniques	p. 244
11.3.1 Preliminary Hazard Analysis	p. 245
11.3.2 Hazard and Operability Study	p. 245
11.3.3 Failure Mode and Effects Analysis	p. 245
11.3.4 Fault Tree Analysis	p. 246
11.4 Risk Evaluation	p. 248
11.5 Risk Control	p. 250
11.6 Postproduction Control	p. 250
11.7 Summary	p. 250
Appendix 11A Robust Design Failure Mode and Effects Analysis	p. 251
11A.1 Parameter Diagram	p. 252
11A.2 Robust Design FMEA Elements	p. 253
12 Medical Device Design for X	p. 259
12.1 Introduction	p. 259
12.2 Design for Reliability	p. 262
12.3 Design for Packaging	p. 265
12.4 Design for Manufacture and Design for Assembly	p. 269
12.4.1 DFMA Approach	p. 269
12.4.2 DFMA in the ICOV DFSS Process	p. 271
12.4.3 DFMA Best Practices	p. 274
12.4.4 Example	p. 280
12.5 Design for Maintainability	p. 281
12.6 Design for Serviceability	p. 282
12.6.1 DFS Guidelines	p. 282
12.6.2 Application: Pressure Recorder PCB Replacement	p. 285
12.7 Summary	p. 290
13 DFSS Transfer Function and Scorecards	p. 291
13.1 Introduction	p. 291
13.2 Design Mapping	p. 292
13.2.1 Functional Mapping	p. 293
13.2.2 Process Mapping	p. 294
13.2.3 Design Mapping Steps	p. 297
13.3 Design Scorecards and the Transfer Function	p. 297
13.3.1 DFSS Scorecard Development	p. 299
13.3.2 Transfer Function Life Cycle	p. 299
13.4 Transfer Function Mathematics	p. 302
13.5 Transfer Function and Optimization	p. 306
13.6 Monte Carlo Simulation	p. 308
13.7 Summary	p. 309
14 Fundamentals of Experimental Design	p. 311
14.1 Introduction	p. 311
14.2 Classical Design of Experiments	p. 314
14.2.1 Study Definition	p. 314
14.3 Factorial Experiment	p. 324
14.3.1 Mathematical Transfer Function	p. 325
14.3.2 Interaction Between Factors	p. 325
14.4 Analysis of Variance	p. 327
14.5 2[superscript k] Full Factorial Designs	p. 332
14.5.1 Design Layout	p. 333
14.5.2 Data Analysis	p. 334
14.5.3 DOE Application	p. 334
14.5.4 The 2[superscript 3] Design	p. 341
14.5.5 The 2[superscript 3] Design with Center Points	p. 342
14.6 Fractional Factorial Designs	p. 343
14.6.1 The 2[superscript 3-1] Design	p. 344
14.6.2 Half-Fractional 2[superscript k] Design	p. 345
14.6.3 Design Resolution	p. 346
14.6.4 One-Fourth Fractional 2[superscript k] Design	p. 347
14.7 Other Factorial Designs	p. 349
14.7.1 Three-Level Factorial Design	p. 349
14.7.2 Box-Behnken Designs	p. 350
14.8 Summary	p. 350
Appendix 14A	p. 351
14A.1 Diagnostic Plots of Residuals	p. 351
14A.2 Pareto Chart of Effects	p. 351
14A.3 Square and Cube Plots	p. 351
14A.4 Interaction Plots	p. 352
15 Robust Parameter Design for Medical Devices	p. 353
15.1 Introduction	p. 353
15.2 Robust Design Fundamentals	p. 354
15.2.1 Robust Design and DFSS	p. 355
15.3 Robust Design Concepts	p. 357
15.3.1 Concept 1: Output Classification	p. 357
15.3.2 Concept 2: Quality Loss Function	p. 358
15.3.3 Concept 3: Signal, Noise, and Control Factors	p. 361
15.3.4 Concept 4: Signal-to-Noise Ratios	p. 362
15.3.5 Concept 5: Orthogonal Arrays	p. 363
15.3.6 Concept 6: Parameter Design Analysis	p. 365
15.4 Application: Dynamic Formulation	p. 368
15.5 Summary	p. 376
16 Medical Device Tolerance Design	p. 377
16.1 Introduction	p. 377
16.2 Tolerance Design and DFSS	p. 378
16.2.1 Application: Imprecise Measurements	p. 380
16.3 Worst-Case Tolerance	p. 382
16.3.1 Application: Internal Pressures in Disposable Tubing	p. 383
16.4 Statistical Tolerances	p. 388
16.4.1 Relationship of Tolerance to Process Capabilities	p. 389
16.4.2 Linear Statistical Tolerance	p. 389
16.4.3 Nonlinear Statistical Tolerance	p. 391
16.5 Taguchi's Loss Function and Safety Tolerance Design	p. 394
16.5.1 Nominal-the-Best Tolerance Design	p. 394
16.5.2 Smaller-the-Better Tolerance Design	p. 396
16.5.3 Larger-the-Better Tolerance Design	p. 397
16.6 High- vs. Low-Level Requirements' Tolerance Relationships	p. 398
16.6.1 Tolerance Allocation for Multiple Parameters	p. 399
16.7 Taguchi's Tolerance Design Experiment	p. 400
16.7.1 Application: Tolerance Design	p. 402
16.8 Summary	p. 404
17 Medical Device DFSS Verification and Validation	p. 405
17.1 Introduction	p. 405
17.2 Design Verification Process	p. 408
17.2.1 Building a Verification Prototype	p. 416
17.2.2 Prototype Testing	p. 417
17.2.3 Confidence Interval of Small-Sample Verification	p. 418
17.3 Production Process Validation	p. 419
17.3.1 Device Verification Analysis	p. 427
17.4 Software Validation	p. 428
17.5 Design Validation	p. 429
17.6 Summary	p. 430
18 DFSS Design Transfer	p. 431
18.1 Introduction	p. 431
18.2 Design Transfer Planning	p. 432
18.3 Process Control Plan	p. 433
18.4 Statistical Process Control	p. 434
18.4.1 Choosing the Control Chart	p. 435
18.4.2 Interpreting the Control Chart	p. 437
18.4.3 Taking Action	p. 438
18.5 Process Capability	p. 438
18.6 Advanced Product Quality Planning	p. 439
18.6.1 APQP Procedure	p. 440
18.6.2 Product Part Approval Process	p. 444
18.7 Device Master Record	p. 446
18.7.1 Document for Intended Employees	p. 449
18.7.2 Adequate Information	p. 451
18.7.3 Preparation and Signatures	p. 452
18.8 Summary	p. 453
19 Design Change Control, Design Review, and Design History File	p. 454
19.1 Introduction	p. 454
19.2 Design Change Control Process	p. 455
19.2.1 Pre- and Postdesign Transfer CCP	p. 455
19.3 Design Review	p. 457
19.4 Design History File	p. 459
19.5 Summary	p. 460
20 Medical Device DFSS Case Study	p. 462
20.1 Introduction	p. 462
20.2 DFSS Identify Phase	p. 462
20.3 DFSS Characterize Phase	p. 467
20.4 DFSS Optimize Phase	p. 470
20.4.1 DOE Optimization Analysis	p. 476
20.4.2 DOE Optimization Conclusions	p. 476
20.4.3 DOE Confirmation Run	p. 479
20.5 DFSS Verify/Validate Phase	p. 480
20.6 Summary	p. 487
Glossary: DFSS Terminology	p. 488
Appendix Statistical Tables	p. 497
References	p. 510
Index	p. 523

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