Human Factors

Human factors is a discipline that seeks to improve human performance in the use of a device/equipment by developing a hardware and software design compatible with the user's abilities. It is often referred as human engineering or ergonomics. A medical device can be used safely and effectively only if the interaction between the operating environment, user capabilities, stress levels, and device design is considered when the manufacturer designs the device.

Device design should take into account the basic physical and sensory capabilities, perceptional and cognitive abilities, device expectations, user's mental model of the device capabilities and design, use environments, and all possible categories of users, including the patients themselves.

User interface designing is an important aspect of an ergonomic design. Some basic considerations include,
* Control/Display Layout and Design
* Simple device logic, microprocessing and software design
* Design and code systems to avoid device mis-installation
* Alarms and alert systems
* Device maintenance
* Packaging

The following figure gives a brief outline of the steps involved in usability engineering or human engineering.

Human Factors Standards and Resources
AAMI HE75 – Design Reference
AAMI HE74 – Human Factors Process
IEC 62366 – (Process) Application of usability engineering to medical devices
FDA.gov; FAA.gov