1st Edition

Handbook of Human Factors in Medical Device Design

    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.

    Introduction, M.E. Wiklund
    General Principles, M.E. Wiklund and M.B. Weinger
    Basic Human Abilities, E.W. Israelski
    Environment of Use, P. Carayon, B. Tzion Karsh, C.J. Alvarado, M.B. Weinger, and M.  Wiklund
    Anthropometry and Biomechanics, W.G. Allread and E.W. Israelski
    Documentation, J.W. Gwynne III and D.A. Kobus
    Testing and Evaluation, E.W. Israelski
    Controls, S.B. Wilcox
    Visual Displays, W.H. Muto and M.E. Maddox
    Connections and Connectors, J.F. Dyro
    Alarm Design, S.B. Wilcox
    Software User Interfaces, M.E. Wiklund
    Workstations, M.E. Wiklund
    Signs, Symbols, and Markings, M.J. Kalsher and M.S. Wogalter
    Packaging, M.E. Maddox and L.W. Avery
    Device Life Cycle, M.E. Maddox and L.W. Avery
    Hand Tool Design, R. Botney, M.B. Privitera, R. Berguer and R. Radwin
    Mobile Medical Devices, R. Stein and M.E. Wiklund
    Home Health Care, D.J. Gardner-Bonneau
    Cross-National and Cross-Cultural Design of Medical Devices, U. Hoelscher, L. Liu, T. Gruchmann, and C. Pantiskas


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

    "... interesting, well-written, and achieves the goal of raising the reader's awareness of important design issues. I loved the book and now that I've told my colleagues they want to read it as well, so we'll buy one for our library since I'm not giving up my copy! Although it is not intended to provide specific solutions to design problems, even a reader with experience in equipment design will most definitely gain new insights into the man-machine interface of medical devices."
    — Jonathan A Gaev, Biomedical Engineering Online

    "… the chapters go far beyond the design process guidance of AAMI’s ANSI standard. It provides expanded discussions of design issues, presents product design case studies, and gives supporting illustrations. … Readers are given a particularly nice treat near the end of this voluminous handbook in the form of a set of photos and short bio sketches about the three editors and the 22 contributors."
    —Gerald P. Krueger, ergonomics in design, July 2013