Handbook of Human Factors in Medical Device Design

Matthew Bret Weinger, Michael E. Wiklund, Daryle Jean Gardner-Bonneau

December 13, 2010 by CRC Press
Reference - 844 Pages
ISBN 9780805856279 - CAT# ER562X

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  • Describes the environmental issues that need to be considered in the process of designing effective and safe medical devices
  • Presents a broad assortment of anthropometric and biomechanical data in tables and figures
  • Takes a human factors–based approach to designing documentation to promote the safe, reliable, and effective use of medical devices
  • Gives guidance on principles for developing usability tests as well as advice on how variables are chosen, controlled, measured, and analyzed
  • Covers display types and software user interfaces, providing general guidance on their selection and use
  • Discusses connections and connectors, alarm systems, workstation design, label design, and packaging
  • Includes a detailed discussion of the differences among device users, ensuring that end-user differences are considered during the device specification, design, and development process
  • Highlights important human factors considerations in the design of mobile medical devices, including detailed design principles derived from human factors literature and professional experience
  • Addresses the special issues involved in designing medical devices for use outside institutional settings by caregivers, including patients, who may have minimal training and/or health literacy


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 on user-centric design supported by discussions of design issues, case studies, and examples.

The book sets the foundation with coverage of fundamental topics such as aligning the interactive nature of medical devices to the expected use environments ranging from hospitals and ambulances to patients’ homes, drawing on anthropometric and biomechanical data to ensure that designs match the intended users’ bodies and physical abilities, and conducting usability tests and other evaluations to ensure that devices perform as intended. It then focuses on applied design issues, offering guidance on the design of specific types of devices and designing devices for particular use environments. Adapted in part from established design standards and conventions, the design guidance presented in this work distills professional judgment extracted from the contributing authors’ years of experience in applied analysis and design.

Written in true handbook style, each chapter stands alone and includes tables, illustrations, and cross references, allowing you to quickly find the exact information you need. Most chapters begin with a general introduction to the selected topic, followed by the presentation of general and special design considerations and then specific, numbered design guidelines. The book also presents a listing of resources, literature, and website references. It not only focuses on the human factors issues that arise when developing medical devices, it supplies the necessary guidance to resolve them.