Applied Human Factors in Medical Device Design describes the contents of a human factors toolbox with in-depth descriptions of both empirical and analytical methodologies. The book begins with an overview of the design control process, integrating human factors as directed by AAMI TIR 59 and experienced practice. It then explains each method, describing why each method is important, its potential impact, when it's ideal to use, and related challenges. Also discussed are other barriers, such as communication breakdowns between users and design teams. This book is an excellent reference for professionals working in human factors, design, engineering, marketing and regulation.
1. I. Introduction - p. xxvii 2. Chapter 1. Introduction & background - p. 3 3. Chapter 2. Overview of a human factors toolbox - p. 19 4. Chapter 3. Strategy, planning, documentation & traceability for human factors - p. 27 5. Chapter 4. How to use this book - p. 39 6. II. Discovery & input methods - p. 41 7. Chapter 5. Contextual inquiry methods - p. 45 8. Chapter 6. Task analysis - p. 63 9. III. Human factors in design - p. 81 10. Chapter 7. Applied human factors in design - p. 85 11. Chapter 8. Combination devices - p. 117 12. Chapter 9. Applying design principles to instructional materials - p. 139 13. IV. Formative design evaluation & reporting - p. 162 14. Chapter 10. Heuristic analysis, cognitive walkthroughs & expert reviews - p. 165 15. Chapter 11. Simulated use formatives - p. 181 16. V. Safety related risk - p. 204 17. Chapter 12. Use-focused risk analysis - p. 207 18. Chapter 13. Root cause analysis - p. 219 19. Chapter 14. Known use error analysis & post market surveillance - p. 237 20. VI. Usability validation & reporting - p. 246 21. Chapter 15. Human factors validation (summative usability) testing including residual risk analysis - p. 249 22. Chapter 16. Human factors validation testing of combination products - p. 271 23. Chapter 17. Preparing an HFE report for agency submission - p. 285 24. VII. Special cases - p. 298 25. Chapter 18. Special cases: introduction - p. 301 26. Chapter 19. The Human Factors of Reprocessing Reusable Medical Equipment - p. 303 27. Chapter 20. Considerations for users with limitations - p. 315 28. Chapter 21. Augmented reality in medical devices - p. 327 29. Index - p. 339
Applied Human Factors in Medical Device Design describes the contents of a human factors toolbox with in-depth descriptions of both empirical and analytical methodologies. The book begins with an overview of the design control process, integrating human factors as directed by AAMI TIR 59 and experienced practice. It then explains each method, describing why each method is important, its potential impact, when it's ideal to use, and related challenges. Also discussed are other barriers, such as communication breakdowns between users and design teams. This book is an excellent reference for professionals working in human factors, design, engineering, marketing and regulation.
1. I. Introduction - p. xxvii 2. Chapter 1. Introduction & background - p. 3 3. Chapter 2. Overview of a human factors toolbox - p. 19 4. Chapter 3. Strategy, planning, documentation & traceability for human factors - p. 27 5. Chapter 4. How to use this book - p. 39 6. II. Discovery & input methods - p. 41 7. Chapter 5. Contextual inquiry methods - p. 45 8. Chapter 6. Task analysis - p. 63 9. III. Human factors in design - p. 81 10. Chapter 7. Applied human factors in design - p. 85 11. Chapter 8. Combination devices - p. 117 12. Chapter 9. Applying design principles to instructional materials - p. 139 13. IV. Formative design evaluation & reporting - p. 162 14. Chapter 10. Heuristic analysis, cognitive walkthroughs & expert reviews - p. 165 15. Chapter 11. Simulated use formatives - p. 181 16. V. Safety related risk - p. 204 17. Chapter 12. Use-focused risk analysis - p. 207 18. Chapter 13. Root cause analysis - p. 219 19. Chapter 14. Known use error analysis & post market surveillance - p. 237 20. VI. Usability validation & reporting - p. 246 21. Chapter 15. Human factors validation (summative usability) testing including residual risk analysis - p. 249 22. Chapter 16. Human factors validation testing of combination products - p. 271 23. Chapter 17. Preparing an HFE report for agency submission - p. 285 24. VII. Special cases - p. 298 25. Chapter 18. Special cases: introduction - p. 301 26. Chapter 19. The Human Factors of Reprocessing Reusable Medical Equipment - p. 303 27. Chapter 20. Considerations for users with limitations - p. 315 28. Chapter 21. Augmented reality in medical devices - p. 327 29. Index - p. 339
