Design of Biomedical Devices and Systems, 4th Edition

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Library of Congress Cataloging‑in‑Publication Data

Names: King, Paul H., 1941- author. | Fries, Richard C., author. | Johnson,
Arthur T. (Arthur Thomas), 1941- author.
Title: Design of biomedical devices and systems / Paul H. King, Richard C.
Fries, Arthur T. Johnson.
Description: Fourth edition. | Boca Raton: Taylor & Francis, 2018. | “A CRC
title, part of the Taylor & Francis imprint, a member of the Taylor &
Francis Group, the academic division of T&F Informa plc.” |
Includes bibliographical references and index.
Identifiers: LCCN 2018025828 | ISBN 9781138723061 (hardback: alk. paper)
Subjects: LCSH: Biomedical engineering.
Classification: LCC R856 .K53 2018 | DDC 610.28—dc23
LC record available at https://lccn.loc.gov/2018025828

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 Whose friendship, support, and love
make me whole.
Richard C. Fries
and
In appreciation for the special people in my life who
have greatly helped me to get this far.
Arthur T. Johnson
Contents
Preface..........................................................................................................................................xxvii
Acknowledgments..........................................................................................................................xxxi
Authors........................................................................................................................................ xxxiii

Chapter 1 Introduction to Biomedical Engineering Design..........................................................1

1.1 What Is Design?..................................................................................................1
1.2 What Is the Thrust of This Text?........................................................................2
1.3 What Might Be Designed?.................................................................................2
1.4 The Essentials of Design—Overview................................................................3
1.5 Biomedical Engineering Design in an Industrial Context................................. 3
1.6 An Overview of the Industrial Design Process..................................................5
1.7 How This Text Is Structured..............................................................................7
1.8 The Real Purpose of This Text...........................................................................7
1.9 Case Study..........................................................................................................7
Homework Exercises.....................................................................................................9
Notes���������������������������������������������������������������������������������������������������������������������������10

Chapter 2 Fundamental Idea Generation Techniques, Process Analysis Tools, and

Evaluation Methods..................................................................................................... 11
2.1  undamental Idea Generation Techniques....................................................... 11
F
2.1.1 Immersion........................................................................................... 11
2.1.2 Removal............................................................................................... 12
2.1.3 Group Brainstorming.......................................................................... 12
2.1.4 Method 635.......................................................................................... 13
2.1.5 Delphi Method (Expert Opinion Extraction)...................................... 13
2.1.6 Synectics.............................................................................................. 13
2.1.7 Thinking Caps..................................................................................... 14
2.1.8 Conventional Solution Searches.......................................................... 14
2.1.8.1 Web-Based and Print Literature.......................................... 14
2.1.8.2 Solutions in Nature and Analogies...................................... 15
2.1.9 SCAMPER.......................................................................................... 15
2.1.10 Beyond SCAMPER, Design Cards..................................................... 17
2.1.11 Introduction to TRIZ........................................................................... 17
2.1.12 Extended TRIZ Design Techniques.................................................... 18
2.1.12.1 The Use of Innovation Workbench...................................... 18
2.1.12.2 Ideation Process................................................................... 19
2.1.12.3 Summary............................................................................. 22
2.2 Function Analysis............................................................................................. 22
2.2.1 Simple Process Charts......................................................................... 23
2.2.2 Clinic Flowcharts................................................................................ 23
2.2.3 Flowcharts with Decision Points.........................................................24
2.2.4 Case Study: Cancer Clinic Charting...................................................26
2.2.4.1 Background..........................................................................26
2.2.4.2 Problem Statement...............................................................26
2.2.4.3 Problem Solution.................................................................26

vii
viii Contents

2.3  lementary Decision-Making Techniques.......................................................26

E
2.3.1 Selection Chart....................................................................................28
2.3.2 Evaluation Charts................................................................................ 29
2.4 Objective Trees................................................................................................. 29
2.5 Introduction to QFD Diagrams........................................................................ 30
2.6 Prototyping....................................................................................................... 32
2.7 Summary.......................................................................................................... 32
Homework Exercises................................................................................................... 32
Suggested Reading...................................................................................................... 33

Chapter 3 Design Team Management, Reporting, and Documentation...................................... 35

3.1 Design Team Construction and Management (Industry-Based)...................... 35
3.1.1 Definition of a Team............................................................................ 36
3.1.2 Characteristics of Teams..................................................................... 36
3.1.3 Team Success Factors.......................................................................... 37
3.1.4 The Team Leader................................................................................ 38
3.1.5 The Design Team................................................................................ 39
3.1.5.1 The Core Product Team....................................................... 39
3.1.5.2 The Working Design Team..................................................40
3.2 Student Design Team Construction and Management.....................................40
3.2.1 Definition of a Student Team..............................................................40
3.2.2 Characteristics of Student Teams........................................................40
3.2.3 Team Success Factors.......................................................................... 41
3.2.4 The Team Leader................................................................................ 41
3.2.5 Special Considerations for Student Design Teams.............................. 41
3.3 Reporting Techniques: Presentations, Posters, Reports, and Websites............ 42
3.3.1 Progress Reports: Written................................................................... 42
3.3.1.1 P rogress Report: EKG Transmitter Project—
Week 7 of 11�������������������������������������������������������������������� 42
3.3.1.2 Progress Report: Transmitter Project, Week 12 of 11
(Sorry This Is Late!)����������������������������������������������������������� 43
3.3.2 Oral Reporting.................................................................................... 43
3.3.3 Poster Presentations............................................................................44
3.3.4 Websites............................................................................................... 45
3.3.5 Expectations for Communications...................................................... 45
3.4 Introduction to Design Project Data Management........................................... 47
3.4.1 Excel Spreadsheets.............................................................................. 47
3.4.2 Databases............................................................................................. 47
3.4.3 Example 3.1: Pain Clinic Database Development............................... 48
3.4.4 R EDCap.............................................................................................. 49
Homework Exercises................................................................................................... 51
Suggested Reading...................................................................................................... 51

Chapter 4 Product Definition....................................................................................................... 53

4.1  hat Is a Medical Device?............................................................................... 53
W
4.1.1 Food and Drug Administration Definition.......................................... 53
4.1.2 The European Union Medical Device Directives Definition.............. 54
4.2 The Product Definition Process........................................................................ 54
4.2.1 Surveying the Customer...................................................................... 54
Contents ix

4.2.2 Defining the Company’s Needs........................................................... 55

4.2.3 What Are the Company’s Competencies?........................................... 55
4.2.4 What Are the Outside Competencies?................................................ 55
4.2.5 Completing the Product Definition..................................................... 55
4.3 The QFD Process............................................................................................. 56
4.3.1 The Voice of the Customer.................................................................. 56
4.3.2 The Technical Portion of the Matrix................................................... 56
4.3.3 Overview of the QFD Process............................................................. 58
4.4 Summary of QFD............................................................................................. 61
4.5 Requirements, Design, Verification, and Validation........................................ 62
4.5.1 Refinement of Requirements...............................................................64
4.5.2 Assimilation of Requirements.............................................................64
4.5.3 Requirements Versus Design.............................................................. 65
4.6 The Product Design Specification....................................................................66
4.7 The Student Product Specification................................................................... 68
4.8 Conclusion........................................................................................................ 70
Homework Exercises................................................................................................... 70
Suggested Reading...................................................................................................... 70
Suggested Web References.......................................................................................... 71

Chapter 5 Product Documentation............................................................................................... 73

5.1 Documents........................................................................................................ 74
5.1.1 The Business Proposal........................................................................ 74
5.1.1.1 Project Overview, Objectives, Major Milestones, and
Schedule������������������������������������������������������������������������������ 74
5.1.1.2 Market Need and Market Potential..................................... 75
5.1.1.3 Product Proposal.................................................................. 76
5.1.1.4 Strategic Fit.......................................................................... 76
5.1.1.5 Risk Analysis and Research Plan........................................ 76
5.1.1.6 Economic Analysis.............................................................. 77
5.1.1.7 Core Project Team............................................................... 77
5.1.2 Product Specification.......................................................................... 78
5.1.3 Design Specification............................................................................ 79
5.1.4 Software Quality Assurance Plan.......................................................80
5.1.4.1 Purpose................................................................................80
5.1.4.2 Reference Documents..........................................................80
5.1.4.3 Management........................................................................80
5.1.4.4 Documentation.....................................................................80
5.1.4.5 Standards, Practices, Conventions, and Metrics..................80
5.1.4.6 Review and Audits...............................................................80
5.1.4.7 Test....................................................................................... 81
5.1.4.8 Problem Reporting and Corrective Action.......................... 81
5.1.4.9 Tools, Techniques, and Methodologies................................ 81
5.1.4.10 Code Control........................................................................ 81
5.1.4.11 Media Control...................................................................... 81
5.1.4.12 Supplier Control................................................................... 81
5.1.4.13 Records Collection, Maintenance, and Retention............... 81
5.1.4.14 Training............................................................................... 81
5.1.4.15 Risk Management................................................................ 81
5.1.4.16 Additional Sections as Required......................................... 81
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5.1.5
 oftware Requirements Specification................................................. 81
S
5.1.5.1 Purpose................................................................................ 82
5.1.5.2 Scope.................................................................................... 82
5.1.5.3 Definitions, Acronyms, and Abbreviations......................... 82
5.1.5.4 References............................................................................ 82
5.1.5.5 Overview.............................................................................. 82
5.1.5.6 Product Perspective............................................................. 82
5.1.5.7 Product Functions................................................................ 82
5.1.5.8 User Characteristics............................................................. 82
5.1.5.9 General Constraints............................................................. 83
5.1.5.10 Assumptions and Dependencies.......................................... 83
5.1.5.11 Specific Requirements......................................................... 83
5.1.6 Software Design Description.............................................................. 83
5.1.6.1 Introduction......................................................................... 83
5.1.6.2 References............................................................................84
5.1.6.3 Decomposition Description.................................................84
5.1.6.4 Dependency Description......................................................84
5.1.6.5 Interface Description...........................................................84
5.1.6.6 Detailed Design Description...............................................84
5.2 Records.............................................................................................................84
5.2.1 The DHF..............................................................................................84
5.2.2 The DMR............................................................................................ 86
5.2.3 The DHR............................................................................................. 86
5.2.4 The TDF.............................................................................................. 86
5.3 A Comparison of the Medical Device Records................................................ 87
5.4 Expectations for Student Project Documentation............................................ 87
5.4.1 Example 5.1 Design Notebook Grading��������������������������������������������� 87
5.4.2 Final Design Project Written Report Grading Sheet Example 5.2........ 90
5.4.3 Senior Design Project Poster and Paper Grading Sheet, ABET
Based, Example 5.3���������������������������������������������������������������������������� 91
Homework Exercises...................................................................................................92
Suggested Reading......................................................................................................92

Chapter 6 Product Development.................................................................................................. 95

6.1  roduct Requirements...................................................................................... 95
P
6.2 Design and Development Planning..................................................................96
6.2.1 Design and Development Plan............................................................97
6.2.1.1 Program Goals.....................................................................97
6.2.1.2 Design and Development Elements.....................................97
6.2.1.3 Organizational and Key Interfaces...................................... 98
6.2.1.4 Deliverables and Responsibilities........................................ 98
6.2.1.5 Design and Development Schedule..................................... 98
6.2.1.6 Approve Design and Development Plan..............................99
6.2.1.7 Incorporate Updates to Design and Development Plan.......99
6.3 System Requirements Specification.................................................................99
6.4 Design Input.....................................................................................................99
6.4.1 Product Requirements....................................................................... 100
6.5  esign Output................................................................................................. 100
D
6.5.1 Intermediate Design Output.............................................................. 101
6.5.2 Final Design Output.......................................................................... 101
Contents xi

6.6  ormal Design Review................................................................................... 102

F
6.6.1 Action Tracking and Issue Resolution............................................... 102
6.7 Design Verification......................................................................................... 102
6.7.1 Design Verification Plan.................................................................... 102
6.7.2 Design Verification Test Methods..................................................... 102
6.7.3 Design Verification Report................................................................ 103
6.8 Design Validation........................................................................................... 103
6.8.1 Design Validation Plan...................................................................... 103
6.8.2 Design Validation Test Methods....................................................... 104
6.8.3 Design Validation Report.................................................................. 105
6.9 Design Transfer.............................................................................................. 105
6.10 Role of the Intern............................................................................................ 105
6.11 Student Project Development Expectations.................................................... 105
Homework Exercises................................................................................................. 106
Suggested Reading.................................................................................................... 106
Web References......................................................................................................... 107

Chapter 7 Hardware Development Methods and Tools............................................................. 109

7.1  esign for Six Sigma...................................................................................... 109
D
7.2 Methodologies................................................................................................ 110
7.3 Structure......................................................................................................... 111
7.4 DFSS Tools..................................................................................................... 111
7.4.1 Robust Design................................................................................... 112
7.4.1.1 Why Use the Robust Design Methodology?...................... 112
7.4.1.2 Typical Problems Addressed By Robust Design............... 112
7.4.1.3 Robustness Strategy........................................................... 113
7.4.1.4 Quality Measurement........................................................ 113
7.4.1.5 S/N Ratio........................................................................... 114
7.4.2 Quality Function Deployment........................................................... 115
7.4.3 Robust Design Failure Mode and Effects Analysis.......................... 115
7.4.3.1 Benefits of a Robust DFMEA............................................ 116
7.4.3.2 The Parameter Diagram.................................................... 116
7.4.3.3 Performing a Robust DFMEA........................................... 117
7.4.3.4 Conclusion......................................................................... 121
7.4.4 Axiomatic Design.............................................................................. 121
7.4.4.1 What is Axiomatic Design?............................................... 121
7.4.4.2 Mapping of Axiomatic Design.......................................... 122
7.5 Component Derating...................................................................................... 124
7.6 Safety Margin................................................................................................. 125
7.7 Load Protection.............................................................................................. 126
7.8 Environmental Protection............................................................................... 126
7.9 Product Misuse............................................................................................... 126
7.10 Reliability Prediction...................................................................................... 127
7.10.1 Parts Count Prediction...................................................................... 127
7.10.2 Parts Count Example......................................................................... 129
7.10.3 Summary of Reliability Prediction................................................... 132
7.11 Design for Variation....................................................................................... 133
7.12 Design of Experiments................................................................................... 133
7.12.1 The Taguchi Method......................................................................... 133
7.13 Design Changes.............................................................................................. 133
xii Contents

7.14 D esign for Manufacturability......................................................................... 134

7.14.1 The DFM Process............................................................................. 135
7.15 Design for Assembly...................................................................................... 135
7.15.1 Overall Design Concept.................................................................... 135
7.15.2 Component Mounting....................................................................... 136
7.15.3 Test Points......................................................................................... 136
7.15.4 Stress Levels and Tolerances............................................................. 136
7.15.5 Printed Circuit Boards....................................................................... 136
7.15.6 Miscellaneous.................................................................................... 136
7.15.7 DFA Process...................................................................................... 136
7.16 Design Reviews.............................................................................................. 137
7.17 Expectations for Student Projects................................................................... 138
Homework Exercises................................................................................................. 138
Suggested Reading.................................................................................................... 139
Web References......................................................................................................... 139

Chapter 8 Software Development Methods and Tools............................................................... 141

8.1  oftware Design Levels.................................................................................. 141
S
8.2 Design Alternatives and Tradeoffs................................................................. 142
8.3 Software Architecture.................................................................................... 142
8.4 Choosing a Methodology................................................................................ 144
8.5 Structured Analysis........................................................................................ 144
8.6 Object-Oriented Design.................................................................................. 145
8.7 Choosing a Language..................................................................................... 145
8.8 Software Risk Analysis.................................................................................. 147
8.9  he RTM........................................................................................................ 147
T
8.10 S oftware Review............................................................................................. 148
8.11 Design Techniques.......................................................................................... 150
8.12 P erformance Predictability and Design Simulation....................................... 150
8.13 M odule Specifications.................................................................................... 151
8.14 C  oding............................................................................................................ 151
8.14.1 Structured Coding Techniques.......................................................... 151
8.14.2 Single-Entry, Single-Exit Constructs................................................ 152
8.14.3 Good Coding Practices..................................................................... 152
8.14.3.1 Review Every Line of Code............................................... 152
8.14.3.2 Require Coding Sign-Offs................................................. 154
8.14.3.3 Route Good Code Examples for Review........................... 154
8.14.3.4 Emphasize that Code Listings are Public Assets.............. 154
8.14.3.5 Reward Good Code........................................................... 154
8.14.3.6 One Easy Standard............................................................ 154
8.14.4 The Coding Process.......................................................................... 155
8.14.4.1 Start with a PDL................................................................ 155
8.14.4.2 Writing the Routine Declaration........................................ 155
8.14.4.3 Turning the PDL into High-Level Comments................... 155
8.14.4.4 Fill in the Code below Each Comment.............................. 155
8.14.4.5 Check the Code Informally............................................... 155
8.14.4.6 Clean Up the Leftovers...................................................... 156
8.14.4.7 Check the Code Formally.................................................. 156
8.14.5 Using Static Analysis to Check Code................................................ 156
8.14.6 Implementation Checklist................................................................. 158
Contents xiii

8.14.7 C oding Examples.............................................................................. 158

8.14.7.1 Example 1.......................................................................... 158
8.14.7.2 Example 2.......................................................................... 159
8.14.7.3 Example 3.......................................................................... 159
8.15 Design Support Tools..................................................................................... 160
8.16 Design as the Basis for Verification and Validation Activity......................... 160
8.17 Design Case Study 8.1.................................................................................... 160
8.18 Notes to Students............................................................................................ 161
8.19 Conclusion...................................................................................................... 161
Homework Exercises................................................................................................. 162
Suggested Reading.................................................................................................... 162
Web References......................................................................................................... 162

Chapter 9 Human Factors.......................................................................................................... 163

9.1 What Is Human Factors?................................................................................ 163
9.2 The Human Element in Human Factors Engineering.................................... 164
9.3 The Hardware Element in Human Factors..................................................... 165
9.4 Software Element in Human Factors.............................................................. 167
9.5 The Human Factors Process........................................................................... 168
9.6 Planning.......................................................................................................... 169
9.7 Analysis.......................................................................................................... 169
9.8 Conduct User Studies..................................................................................... 169
9.8.1 Observations...................................................................................... 169
9.8.2 Interviews.......................................................................................... 170
9.8.3 Focus Groups..................................................................................... 170
9.8.4 Task Analysis.................................................................................... 171
9.8.5 Benchmark Usability Test................................................................. 171
9.8.6 Write User Profile.............................................................................. 171
9.8.7 Setup an Advisory Panel................................................................... 171
9.9 Set Usability Goals......................................................................................... 171
9.10 Design User Interface Concepts..................................................................... 172
9.10.1 Develop Conceptual Model............................................................... 172
9.10.2 Develop User Interface Structure...................................................... 172
9.10.3 Define Interaction Style..................................................................... 172
9.10.4 Develop Screen Templates................................................................ 172
9.10.5 Develop Hardware Layout................................................................. 173
9.10.6 Develop a Screenplay........................................................................ 173
9.10.7 Develop a Refined Design and Final Design..................................... 173
9.11 Model the User Interface................................................................................ 173
9.12 Test the User Interface.................................................................................... 173
9.13 Specify the User Interface.............................................................................. 174
9.13.1 Style Guide........................................................................................ 174
9.13.2 Screen Hierarchy Map....................................................................... 174
9.13.3 Screenplay......................................................................................... 174
9.13.4 Specification Prototype..................................................................... 174
9.13.5 Hardware Layouts............................................................................. 174
9.14 Additional Human Factors Design Considerations........................................ 175
9.14.1 Consistency and Simplicity............................................................... 175
9.14.2 Safety................................................................................................. 175
9.14.3 Environmental/Organizational Considerations................................. 175
xiv Contents

9.14.4 Documentation.................................................................................. 176

9.14.5 Anthropometry.................................................................................. 176
9.14.6 Functional Dimensions...................................................................... 177
9.14.7 Psychological Elements..................................................................... 178
9.14.8 Workstation Design Considerations.................................................. 178
9.14.9 Alarms and Signals........................................................................... 179
9.14.10 Labeling............................................................................................. 181
9.14.11 Software............................................................................................ 182
9.14.12 Data Entry......................................................................................... 182
9.14.13 Displays............................................................................................. 183
9.14.14 Interactive Control............................................................................. 184
9.14.15 Feedback............................................................................................ 184
9.14.16 Prompts............................................................................................. 185
9.14.17 Defaults............................................................................................. 185
9.14.18 Data Correction................................................................................. 185
9.15 Fitts’ Law........................................................................................................ 185
9.15.1 The Model......................................................................................... 186
Homework Exercises................................................................................................. 186
Suggested Reading.................................................................................................... 187

Chapter 10 Industrial Design....................................................................................................... 189

10.1 Set Usability Goals......................................................................................... 190
10.2 Design UI Concepts........................................................................................ 190
10.2.1 Develop Conceptual Model............................................................... 191
10.2.2 Develop UI Structure........................................................................ 192
10.2.3 Define Interaction Style..................................................................... 192
10.2.4 Develop Screen Templates................................................................ 193
10.2.5 Develop Hardware Layout................................................................. 193
10.2.6 Develop a Screenplay........................................................................ 193
10.2.7 Develop a Refined Design................................................................. 193
10.2.8 Develop a Final Design..................................................................... 193
10.3 Model the UI.................................................................................................. 193
10.4 Test the UI...................................................................................................... 194
10.5 Specify the UI................................................................................................ 195
10.5.1 Style Guide........................................................................................ 195
10.5.2 Screen Hierarchy Map....................................................................... 195
10.5.3 Screenplay......................................................................................... 195
10.5.4 Specification Prototype..................................................................... 195
10.5.5 Hardware Layouts............................................................................. 195
10.6 Additional Industrial Design Considerations................................................. 195
10.6.1 Consistency and Simplicity............................................................... 195
10.6.2 Safety................................................................................................. 196
10.6.3 Environmental/Organizational Considerations................................. 196
10.6.4 Documentation.................................................................................. 196
10.6.5 Alarms and Signals........................................................................... 197
10.6.6 Displays............................................................................................. 199
10.6.7 Interactive Control.............................................................................200
10.6.8 Software............................................................................................ 201
10.6.9 Data Entry......................................................................................... 201
10.6.10 Feedback............................................................................................202
Contents xv

10.6.11 Error Management/Data Protection..................................................202

10.7 FDA Thoughts................................................................................................202
10.8 Lessons for Students.......................................................................................203
Homework Exercises.................................................................................................204
Suggested Readings...................................................................................................204
Web References.........................................................................................................205

Chapter 11 Biomaterials and Material Testing............................................................................207

11.1  he FDA and Biocompatibility......................................................................208
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11.2 ISO 10993....................................................................................................... 211
11.3 Device Category and Choice of Test Program............................................... 213
11.4 Preparation of Extracts................................................................................... 214
11.5 Biological Control Tests................................................................................. 215
11.5.1 Microbiological Control Tests........................................................... 215
11.5.2 Tests for Endotoxins.......................................................................... 215
11.5.3 Test for Nonspecific Toxicity............................................................. 216
11.6 Tests for Biological Evaluation....................................................................... 216
11.6.1 Cytotoxicity....................................................................................... 216
11.6.2 Sensitization...................................................................................... 216
11.6.3 Skin Irritation.................................................................................... 217
11.6.4 Intracutaneous Reactivity.................................................................. 217
11.6.5 Acute Systemic Toxicity.................................................................... 217
11.6.6 Genotoxicity...................................................................................... 218
11.6.7 Implantation...................................................................................... 218
11.6.8 Hemocompatibility............................................................................ 218
11.6.9 Subchronic and Chronic Toxicity...................................................... 219
11.6.10 Carcinogenicity................................................................................. 219
11.7 Animal Testing............................................................................................... 219
11.7.1 Animal Models.................................................................................. 220
11.8 Nanotechnology.............................................................................................. 220
11.9 Alternative Test Methods............................................................................... 222
11.10 Endnote........................................................................................................... 223
Homework Exercises................................................................................................. 223
References................................................................................................................. 223
Suggested Readings...................................................................................................224
Web References.........................................................................................................224

Chapter 12 Risk Analysis—Devices and Processes.................................................................... 225

12.1  afety.............................................................................................................. 225
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12.2 Risk................................................................................................................. 226
12.3 Deciding on Acceptable Risk......................................................................... 228
12.4 Factors Important for Medical Device Risk Assessment............................... 228
12.4.1 Device Design and Manufacture....................................................... 229
12.4.2 Materials............................................................................................ 229
12.4.3 Device Users...................................................................................... 229
12.4.4 Human Factors.................................................................................. 229
12.4.5 Medical Device Systems................................................................... 230
12.5 Risk Management........................................................................................... 230
12.6 The Risk Management Process...................................................................... 230
xvi Contents

12.6.1 Identifying the Risk Factors.............................................................. 230

12.6.2 Assessing Risk Probabilities and Risks on the Project..................... 231
12.6.3 Developing Strategies to Mitigate Identified Risks........................... 232
12.6.4 Monitoring Risk Factors................................................................... 232
12.6.5 Invoking a Contingency Plan............................................................ 232
12.6.6 Managing the Crisis.......................................................................... 233
12.6.7 Recovering from the Crisis............................................................... 233
12.7 Tools for Risk Estimation............................................................................... 233
12.7.1 Hazard/Risk Analysis....................................................................... 233
12.7.2 Failure Mode and Effects Analysis................................................... 235
12.7.3 Fault Tree Analysis............................................................................ 237
12.7.3.1 The FTA Process............................................................... 237
12.7.3.2 Example of an FTA........................................................... 238
12.8 Risk Analysis and Systems............................................................................. 239
12.8.1 Medical Case Example......................................................................240
12.8.2 Safety in Design................................................................................ 242
12.8.3 Medical Case Example—Revisited.................................................. 243
12.8.4 Process Improvement........................................................................244
12.8.5 Miscellaneous Issues......................................................................... 245
12.9 ISO 14971....................................................................................................... 245
12.10 Other Process Issues.......................................................................................246
12.11 Risk and the FDA........................................................................................... 247
12.12 MAUDE and MDR.........................................................................................248
12.13 Summary........................................................................................................ 249
Homework Exercises................................................................................................. 249
Notes�������������������������������������������������������������������������������������������������������������������������249
Suggested Reading.................................................................................................... 250
Web References......................................................................................................... 250

Chapter 13 Testing....................................................................................................................... 251

13.1 Testing Defined............................................................................................... 251
13.2 Parsing Test Requirements............................................................................. 252
13.3 Test Protocol................................................................................................... 253
13.4 Test Methodology........................................................................................... 254
13.4.1 Time Testing...................................................................................... 254
13.4.2 Event Testing..................................................................................... 254
13.4.3 Stress Testing.....................................................................................254
13.4.4 Environmental Testing...................................................................... 254
13.4.5 Time Related..................................................................................... 254
13.4.6 Failure Related.................................................................................. 255
13.5 Purpose of the Test......................................................................................... 255
13.6 Failure Definition........................................................................................... 255
13.7 Determining Sample Size and Test Length.................................................... 256
13.7.1 Example 13.1..................................................................................... 256
13.7.2 Example 13.2..................................................................................... 257
13.8 Types of Testing.............................................................................................. 258
13.8.1 Verification........................................................................................ 258
13.8.2 Validation.......................................................................................... 258
13.8.3 Black Box.......................................................................................... 258
13.8.4 White Box......................................................................................... 258