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Applied Human Factors in Medical Device Design

Langue : Anglais

Coordonnateur : Privitera Mary Beth

Couverture de l’ouvrage Applied Human Factors in Medical Device Design

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. 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

Medical device industry professionals in human factors, design, engineering, marketing and regulatory. 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.

Privitera’s research focus is in collaborative medical device design and the application of human factors in design. She is a member of the Association for the Advancement of Medical Instrumentation Human Factors Committee and has coauthored various sections in HE 75 and recently a TIR on Contextual Inquiry. To date, she has been associated with more than 40 product releases, holds several patents and provisional patents, and has published and lectured on a variety of topics including design research, transdisciplinary/collaborative design, innovation methodology, and surgical techniques.
  • 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

Date de parution :

Ouvrage de 368 p.

19x23.3 cm

Disponible chez l'éditeur (délai d'approvisionnement : 14 jours).

146,54 €

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