Software as a Medical Device
Second Edition
x Regulatory Affairs Professionals Society
Chapter 9: Open Source and Third-Party Software. .........................................................................................................99
Siegfried Schmitt, PhD
Introduction. ...................................................................................................................................................................................99
Terminology. ...................................................................................................................................................................................99
Discussion. ......................................................................................................................................................................................99
What Are the Concerns About Open-Source Software Components?....................................................................................100
What Are the Concerns About Third-Party (Commercial) Software Components?. ..............................................................100
AI components..............................................................................................................................................................................101
Case Studies. .................................................................................................................................................................................102
Conclusion. ...................................................................................................................................................................................104
Chapter 10: User Experience Design. .............................................................................................................................107
Koen Cobbaert, MSc
Introduction. .................................................................................................................................................................................107
Why User Experience Design?......................................................................................................................................................107
Simpler and Smarter. ....................................................................................................................................................................107
Human Oversight. ........................................................................................................................................................................108
Automation Bias............................................................................................................................................................................109
Transparency and Interpretability of Output.................................................................................................................................109
Design for Happiness....................................................................................................................................................................111
Usability and User Interfaces.........................................................................................................................................................112
Intended User................................................................................................................................................................................112
Personas.........................................................................................................................................................................................112
User Needs, Requirements, and Specifications. .............................................................................................................................112
Roles and Responsibilities. ............................................................................................................................................................113
User Experience Design Specialist. ...............................................................................................................................................114
Identifying Usability-Sensitive User Needs...................................................................................................................................115
Use Scenarios. ...............................................................................................................................................................................115
Usability Goals. .............................................................................................................................................................................116
Documenting Usability Goals. ......................................................................................................................................................116
Usability Evaluation. .....................................................................................................................................................................117
User Interface Requirements and Design Specifications. ..............................................................................................................117
Formative Evaluation. ...................................................................................................................................................................118
User Observation...........................................................................................................................................................................118
Walkthrough Evaluation. ..............................................................................................................................................................119
Heuristics Analysis........................................................................................................................................................................119
Severity Scale.................................................................................................................................................................................120
Design Principle #1: Focus on Core Functionality........................................................................................................................121
Design Principle #2: Understandability Before Simplicity. ...........................................................................................................121
Design Principle #3: Self-Evident and Self-Learnable. ................................................................................................................122
Design Principle #4: Mobile First. ................................................................................................................................................122
Information Architecture Principles..............................................................................................................................................123
Verification and Validation. ...........................................................................................................................................................123
Number of Testers. ........................................................................................................................................................................123
Tester Training. .............................................................................................................................................................................123
Single Ease Question. ...................................................................................................................................................................123
Product Reaction and Word Association Cards. ...........................................................................................................................123
System Usability Score. .................................................................................................................................................................124
Acceptance Criteria.......................................................................................................................................................................125
Product Safety Risk Management.................................................................................................................................................127
Regulatory Standards and Requirements......................................................................................................................................127
Conclusion. ...................................................................................................................................................................................128
Acknowledgement.........................................................................................................................................................................128
Chapter 11: Artificial Intelligence..................................................................................................................................131
Koen Cobbaert, MSc
Introduction. .................................................................................................................................................................................131
Second Edition
x Regulatory Affairs Professionals Society
Chapter 9: Open Source and Third-Party Software. .........................................................................................................99
Siegfried Schmitt, PhD
Introduction. ...................................................................................................................................................................................99
Terminology. ...................................................................................................................................................................................99
Discussion. ......................................................................................................................................................................................99
What Are the Concerns About Open-Source Software Components?....................................................................................100
What Are the Concerns About Third-Party (Commercial) Software Components?. ..............................................................100
AI components..............................................................................................................................................................................101
Case Studies. .................................................................................................................................................................................102
Conclusion. ...................................................................................................................................................................................104
Chapter 10: User Experience Design. .............................................................................................................................107
Koen Cobbaert, MSc
Introduction. .................................................................................................................................................................................107
Why User Experience Design?......................................................................................................................................................107
Simpler and Smarter. ....................................................................................................................................................................107
Human Oversight. ........................................................................................................................................................................108
Automation Bias............................................................................................................................................................................109
Transparency and Interpretability of Output.................................................................................................................................109
Design for Happiness....................................................................................................................................................................111
Usability and User Interfaces.........................................................................................................................................................112
Intended User................................................................................................................................................................................112
Personas.........................................................................................................................................................................................112
User Needs, Requirements, and Specifications. .............................................................................................................................112
Roles and Responsibilities. ............................................................................................................................................................113
User Experience Design Specialist. ...............................................................................................................................................114
Identifying Usability-Sensitive User Needs...................................................................................................................................115
Use Scenarios. ...............................................................................................................................................................................115
Usability Goals. .............................................................................................................................................................................116
Documenting Usability Goals. ......................................................................................................................................................116
Usability Evaluation. .....................................................................................................................................................................117
User Interface Requirements and Design Specifications. ..............................................................................................................117
Formative Evaluation. ...................................................................................................................................................................118
User Observation...........................................................................................................................................................................118
Walkthrough Evaluation. ..............................................................................................................................................................119
Heuristics Analysis........................................................................................................................................................................119
Severity Scale.................................................................................................................................................................................120
Design Principle #1: Focus on Core Functionality........................................................................................................................121
Design Principle #2: Understandability Before Simplicity. ...........................................................................................................121
Design Principle #3: Self-Evident and Self-Learnable. ................................................................................................................122
Design Principle #4: Mobile First. ................................................................................................................................................122
Information Architecture Principles..............................................................................................................................................123
Verification and Validation. ...........................................................................................................................................................123
Number of Testers. ........................................................................................................................................................................123
Tester Training. .............................................................................................................................................................................123
Single Ease Question. ...................................................................................................................................................................123
Product Reaction and Word Association Cards. ...........................................................................................................................123
System Usability Score. .................................................................................................................................................................124
Acceptance Criteria.......................................................................................................................................................................125
Product Safety Risk Management.................................................................................................................................................127
Regulatory Standards and Requirements......................................................................................................................................127
Conclusion. ...................................................................................................................................................................................128
Acknowledgement.........................................................................................................................................................................128
Chapter 11: Artificial Intelligence..................................................................................................................................131
Koen Cobbaert, MSc
Introduction. .................................................................................................................................................................................131