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OverviewApplied 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. Full Product DetailsAuthor: Mary Beth Privitera (Director, Medical Device Engine, University of Cincinnati Medical Center, Cincinnatti, OH, USA)Publisher: Elsevier Science Publishing Co Inc Imprint: Academic Press Inc Weight: 0.770kg ISBN: 9780128161630ISBN 10: 0128161639 Pages: 368 Publication Date: 18 June 2019 Audience: Professional and scholarly , Professional & Vocational Replaced By: 9780443417061 Format: Paperback Publisher's Status: Active Availability: Manufactured on demand ![]() We will order this item for you from a manufactured on demand supplier. Table of Contents1. Background on the application of HF in medical device design 2. Contents of a HF Toolbox 3. Contextual Inquiry Methods (TIR 51) 4. Heuristic Evaluation/Cognitive Walkthroughs 5. Task Analysis 6. Competitive Ergonomic Analysis 7. Known Use Error and Post Market Surveillance 8. Applied Ergonomics for UI/UX Product Design (HE 75) 9. Applied Ergonomics in Instructions for Use 10. Formative Usability Testing 11. User focused Risk Analysis 12. Summative Usability Testing 13. Preparing an HFE Report for agency submission 14. Special casesReviews""Overall, this text is a very good contribution to the literature and is recommended for those persons entering medical device design. It gives a very good overview of the need for and use of human factors in medical device design, especially as experienced in the United States. All information is logically presented and is, as is necessary, very patient-centric."" --IEEE Overall, this text is a very good contribution to the literature and is recommended for those persons entering medical device design. It gives a very good overview of the need for and use of human factors in medical device design, especially as experienced in the United States. All information is logically presented and is, as is necessary, very patient-centric. --IEEE """Overall, this text is a very good contribution to the literature and is recommended for those persons entering medical device design. It gives a very good overview of the need for and use of human factors in medical device design, especially as experienced in the United States. All information is logically presented and is, as is necessary, very patient-centric."" --IEEE" Author InformationDr. 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. Tab Content 6Author Website:Countries AvailableAll regions |