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.
General
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