ABSTRACT
This chapter covers several of the relevant considerations that a project must consider. The use of human factors is mandated by the Food and Drug Administration (FDA) when documentation is required on devices; thus this is an important design consideration. Human factors engineering emerged as a recognized discipline during World War II while focusing primarily on military system performance, including problems in signal detection, workspace constraints, and optimal task training. Numerous medical device companies have established human factors engineering programs to ensure the usability and safety of their devices. These companies also believe that their human factors engineering efforts enhance the marketability of their products. The human element addresses several user characteristics, including memory and knowledge presentation, thinking and reasoning, visual perception, dialog construction, individual skill level, and individual sophistication. The hardware element considers size limitations, the location of controls, compatibility with other equipment, the potential need for portability, and possible user training.
