What to Consider When Designing Human Factor Studies

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Human factor studies are an integral part of any device or drug delivery system submission. The Food and Drug Administration requires them to fulfill the requirements for device safety.

As such, pharmaceutical and medical device executives should understand what human factor studies are, what regulations govern human factor studies, what factors to consider when designing human factor studies, and how to conduct human factor studies.

What is a Human Factor?

”Human factor" is a term used to describe the application of the knowledge of human abilities and limitations to the design of devices. It has to do with the usability of devices and how it determines the efficacy, efficiency, and the ease of learning and satisfaction of the user.

The Food and Drug Administration is concerned with studies of human factors because human factors influence the safety and efficacy of a device. The Food and Drug Administration expects device manufacturers to conduct a comprehensive risk assessment of the device, identify and decrease risks, and conduct human factor and design validation studies designed to decrease any risks. Device companies should then document these studies in the design history file.

Regulations and Guidances that Pertain to Human Factor Studies

The need for the inclusion of human factor studies is governed by 21 Code of Federal Regulations Part 820.30. This regulation contains provisions for the design input, verification, and validation of a device. The design input refers to the needs of the patient as they relate to the safety and efficacy of the device.

Through the testing of the design input, researchers ascertain whether users can operate the device without injuring themselves or others and in a manner consistent with its intended use.

Through the application of human factors methods, manufacturers should attempt to eliminate errors of use and failures of the device to the greatest possible extent. Through verification and validation of the design, researchers determine whether they made the device correctly and whether the device suits the needs of the population for which it was made.
Other guidances of interest include AAMI/IEC 62366-1:2015 and IEC 60601-1-6 third edition.

AAMI/IEC 62366-1:2015 provides a structured approach to conducting human factor studies. Specific features include an overview of the design process for human factor studies, planning of human factor studies, and methods and techniques for conducting human factor studies. IEC 60601-1-6 third edition includes general provisions for the risk management process for medical electrical equipment and the usability engineering process.

 
 
 

Factors to Consider When Designing Human Factor Studies

When designing human factor studies, device companies should consider the population for which the device is intended, the environment, and possible interface issues. Device companies should determine whether the population using the device comprises professionals or nonprofessionals, what the users’ education levels are, what age the users are, what functional limitations they may have, and what mental and sensory conditions they may have.

The environment in which the device will be used should also be considered. Some possible environments include a hospital; transitional care center; home; a community setting such as a school, office, or park; and a mobile environment such as a car or ambulance.

Interface issues include the set-up, cleaning, maintenance, and disposal of the device; interactive features of the device such as plugs, touchscreens, and knobs; and sensory components such as displays, alarms, and vibration.

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Topics: Process