Applied Human Factors in Medical Device Design describes the contents of a human factors toolbox with in depth descriptions of both empirical and analytical methodology. The book aims to improve the ability of designers and auditors to determine the safety and efficacy of a product through the use of design controls and methods. It begins with an overview of the design control process integrating human factors as directed by AAMI TIR 59 and experienced practice. It then goes on to explain each method and describes, in detail, why each method is important, the potential impact, when it is ideal to use or not use, and challenges that may occur. Also discussed are the challenges wherein barriers, such as communication breakdowns between users and design teams hindered integrating human factors in medical device design. Applied Human Factors in Medical Device Design is an excellent reference for Medical device industry professionals in human factors, design, engineering, marketing and regulatory. 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 in consideration of the healthcare environment.Covers FDA and MHRA regulations.Case examples included with each method. INDICE: 1. Background on the application of HF in medical device design2. Contents of a HF Toolbox3. Contextual Inquiry Methods (TIR 51)4. Heuristic Evaluation/Cognitive Walkthroughs5. Task Analysis6. Competitive Ergonomic Analysis7. Known Use Error and Post Market Surveillance8. Applied Ergonomics for UI/UX Product Design (HE 75)9. Applied Ergonomics in Instructions for Use10. Formative Usability Testing 11. User focused Risk Analysis12. Summative Usability Testing13. Preparing an HFE Report for agency submission14. Special cases
- ISBN: 978-0-12-816163-0
- Editorial: Academic Press
- Encuadernacion: Rústica
- Páginas: 352
- Fecha Publicación: 01/06/2019
- Nº Volúmenes: 1
- Idioma: Inglés