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Human Factors & Ergonomics
OUR SERVICES: We can assist you with all aspects of human factors and
ergonomics (HF&E) design & analysis of your medical device or health information
system. We use standard tools (e.g., function & task analysis software), as well as
proprietary analytic tools and templates to conduct efficiently a comprehensive
HF&E analysis of your specific medical device or information system, its intended
user(s) and intended use environment(s). We then use this to assist you in your
HW, SW, and labeling design, risk management, and testing efforts. We also can
help you design, execute, analyze, and document HF&E validation studies, including
labeling studies, usability studies, and clinical use trials.
OUR PRINCIPALS: One of our principals is a board-certified human factors
engineer with extensive medical device design & analysis experience. The other is
a clinician with extensive human factors experience and real-world experience using
medical devices and healthcare information systems.
System Use and user errors may be the last bastion of equipment and process
safety and effectiveness problems. The source of use and user errors can be the
result of problems with equipment development, deployment, and maintenance
and/or can be the result of problems with user training, work structure, and the work
environment (see upper figure on the right and a recent article by one of our
principals describing 3 case studies). While it was previously thought that design
problems could be alleviated with labeling and training, this is now generally
recognized not to be the case. The discipline of human factors & ergonomics
(HF&E) has a body of knowledge to deal with the interaction of humans and their
artifacts and with the design of systems in which people participate.
HF&E engineering is fundamentally about developing, deploying, and maintaining
products, processes, and services for human use. The discipline can be roughly
divided into sets of 4 major areas (see lower figure on right): physical ergonomics,
information management ergonomics, social ergonomics, and cultural ergonomics.
For greater detail, please see recent article by both of our principals. HF&E
engineering considerations participate in a manner similar to hardware, software,
and economic considerations in the development of requirements, in compliance
with appropriate regulations and standards, and in the engineering of system
reliability and system safety & security (please refer to middle figure on
mechatronics page). HF&E considerations are important at all stages of the system
lifecycle (development, deployment, maintenance, and disposal). Two critical
activities for medical device developers are: “formative” evaluations (design
verifications; 21 CFR 820.30f) and “summative” evaluation (design validation; 21
CFR 820.30g). The FDA requires specific HF&E design documentation, as shown in
the lower table on the right.
HF&E engineering is not merely about usability or user experience, although these
are important factors. "Cradle to grave" HF&E engineering addresses not only
physical, behavioral, social, and cultural factors of the intended user(s) (e.g.,
clinicians, BMETs, managers, etc.) in the intended use environment(s), but also
addresses the HF&E issues during development (e.g., integration of hardware,
software, and human factors design and testing) and during deployment (e.g.,
selection, installation, maintenance, and disposal). Please refer to Figure 5 in a
recent article by one of our principals on avoiding system use errors during
development and deployment.