Humanizing Healthcare Human Factors For Medical Device Design

This book introduces human factors engineering (HFE) principles, guidelines, and design methods for medical device design. It starts with an overview of physical, perceptual, and cognitive abilities and limitations, and their implications for design. This analysis produces a set of human factors principles that can be applied across many design challenges, which are then applied to guidelines for designing input controls, visual displays, auditory displays (alerts, alarms, warnings), and human-computer interaction. Specific challenges and solutions for various medical device domains, such as robotic surgery, laparoscopic surgery, artificial organs, wearables, continuous glucose monitors and insulin pumps, and reprocessing, are discussed. Human factors research and design methods are provided and integrated into a human factors design lifecycle, and a discussion of regulatory requirements and procedures is provided, including guidance on what human factors activities should be conducted when and how they should be documented. This hands-on professional reference is an essential introduction and resource for students and practitioners in HFE, biomedical engineering, industrial design, graphic design, user-experience design, quality engineering, product management, and regulatory affairs. Teaches readers to design medical devices that are safer, more effective, and less error prone; Explains the role and responsibilities of regulatory agencies in medical device design; Introduces analysis and research methods such as UFMEA, task analysis, heuristic evaluation, and usability testing.

This book introduces human factors engineering (HFE) principles, guidelines, and design methods for medical device design. It starts with an overview of physical, perceptual, and cognitive abilities and limitations, and their implications for design. This analysis produces a set of human factors principles that can be applied across many design challenges, which are then applied to guidelines for the design of input controls, visual displays, auditory displays (alerts, alarms, warnings) and human-computer interaction. Specific challenges and solutions for various medical device domains, such as robotic surgery, laparoscopic surgery, artificial organs, wearables, continuous glucose monitors and insulin pumps, and reprocessing, are discussed. Human factors research and design methods are provided and integrated into a human factors design lifecycle, and a discussion of regulatory requirements and procedures is provided, including guidance on what human factors activities should be conducted when, and how they should be documented. This hands-on professional reference is an essential introduction and resource for students and practitioners in HFE, biomedical engineering, industrial design, graphic design, user-experience design, quality engineering, product management, and regulatory affairs.

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

Developed to promote the design of safe, effective, and usable medical devices, Handbook of Human Factors in Medical Device Design provides a single convenient source of authoritative information to support evidence-based design and evaluation of medical device user interfaces using rigorous human factors engineering principles. It offers guidance

Advocating a user-centered approach to medical technology design, Designing Usability into Medical Products covers the essential processes and specific techniques necessary to produce safe, effective, usable, and appealing medical systems and products. Written by experts on user-centered research, design, and evaluation, the book provides a range o