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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. 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. Review: \"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. Review: A ‘human factors toolbox’ that guides users through the process of integrating human factors into medical device design. About the Author: 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 hum Key topics: • 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)\n• Explains technology development and the application of human factors throughout the development process\n• Covers FDA and MHRA regulations\n• Includes case examples with each method