1. 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 cases
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.
"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
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