Applied Human Factors in Medical Device Design
- 1st Edition - June 15, 2019
- Imprint: Academic Press
- Editor: Mary Beth Privitera
- Language: English
- Paperback ISBN:9 7 8 - 0 - 1 2 - 8 1 6 1 6 3 - 0
- eBook ISBN:9 7 8 - 0 - 1 2 - 8 1 6 1 6 4 - 7
Applied Human Factors in Medical Device Design describes the contents of a human factors toolbox with in-depth descriptions of both empirical and analytical methodolo… Read more
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Request a sales quoteApplied 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.
- Focuses on meeting agency requirements as it pertains to the application of human factors in the medical device development process in both the US and the European Union (EU)
- Explains technology development and the application of human factors throughout the development process
- Covers FDA and MHRA regulations
- Includes case examples with each method
Medical device industry professionals in human factors, design, engineering, marketing and regulatory agencies. Students in human factors, experimental psychology, industrial design, design research, ergonomics, and biomedical engineering. Consultants and specialists of health technology assessment. Clinical engineers and health technology managers
Chapter 1. Background on the application of HF in medical device design
a. Applicable international standards
b. Incorporating HF in early product development and design control (TIR 59)
Chapter 2. Contents of a HF Toolbox
a. Brief description of each tool
b. Overview of when to use/when not to use tools
Chapter 3. Contextual Inquiry Methods (TIR 51)
Chapter 4. Heuristic Evaluation/Cognitive Walkthroughs
Chapter 5. Task Analysis
Chapter 6. Competitive Ergonomic Analysis
a. Subtle differences in design, manufacturing impact the “feel” of a device
Chapter 7. Known Use Error and Post Market Surveillance
a. Database searches
b. Internal quality reporting
Chapter 8. Applied Ergonomics for UI/UX Product Design (HE 75)
a. Hardware
i. Fit: anthropometry
ii. Physical Interactions: biomechanics
b. Software
Chapter 9. Applied Ergonomics in Instructions For Use
Chapter 10. Formative Usability Testing
Chapter 11. User focused Risk Analysis
a. AFMEA
b. Other tools
Chapter 12. Summative Usability Testing
a. Root Cause Analysis
Chapter 13. Preparing an HFE Report for agency submission
Chapter 14. Special cases:
a. Combination Products
b. At- Risk User Populations
a. Applicable international standards
b. Incorporating HF in early product development and design control (TIR 59)
Chapter 2. Contents of a HF Toolbox
a. Brief description of each tool
b. Overview of when to use/when not to use tools
Chapter 3. Contextual Inquiry Methods (TIR 51)
Chapter 4. Heuristic Evaluation/Cognitive Walkthroughs
Chapter 5. Task Analysis
Chapter 6. Competitive Ergonomic Analysis
a. Subtle differences in design, manufacturing impact the “feel” of a device
Chapter 7. Known Use Error and Post Market Surveillance
a. Database searches
b. Internal quality reporting
Chapter 8. Applied Ergonomics for UI/UX Product Design (HE 75)
a. Hardware
i. Fit: anthropometry
ii. Physical Interactions: biomechanics
b. Software
Chapter 9. Applied Ergonomics in Instructions For Use
Chapter 10. Formative Usability Testing
Chapter 11. User focused Risk Analysis
a. AFMEA
b. Other tools
Chapter 12. Summative Usability Testing
a. Root Cause Analysis
Chapter 13. Preparing an HFE Report for agency submission
Chapter 14. Special cases:
a. Combination Products
b. At- Risk User Populations
- Edition: 1
- Published: June 15, 2019
- Imprint: Academic Press
- No. of pages: 368
- Language: English
- Paperback ISBN: 9780128161630
- eBook ISBN: 9780128161647
MP
Mary Beth Privitera
Dr. Mary Beth Privitera, M.Design, FIDSA, is internationally known as an expert in medical product design, specifically in the area of applied human factors. She is a Professor at the University of Cincinnati’s Department of Biomedical Engineering and works collaboratively among the Colleges of Medicine, Engineering and Design. She is a consultant to the medical device industry with expertise in user interaction design and human factors. Additionally, she serves as faculty and co-chair of the Association for the Advancement of Medical Instrumentation’s Human Engineering Committee.
As a Professor at the University of Cincinnati’s Department of Biomedical Engineering, she is a Co-Founder of the Medical Device Innovation and Entrepreneurship Program. Her previous academic appointments include industrial design and in the Department of Emergency Medicine.
She has worked on devices which are intended for use across the practice of medicine and in home health situations. Her current research focuses on applied ergonomics and design interpretation. She has conducted contextual inquiry studies throughout the hospital with results intended to inform the design of devices, including physiologic monitoring and clinical decision making, software-based tools including intraprocedural augmented reality. In addition, she currently has had research funding supported by the Gates Foundation and US FDA CDER Division. She is a Fulbright Scholar in collaboration with the University of Nottingham.
Affiliations and expertise
Director, Medical Device Engine, University of Cincinnati Medical Center, Cincinnatti, OH, USARead Applied Human Factors in Medical Device Design on ScienceDirect