Human Factors Engineering and the Design of Medical Devices

Human Factors Engineering (HFE) involves the application of knowledge about human capabilities to the design of products. Through good design practice, HFE aims to assist users to accomplish their tasks efficiently, effectively, and safely as they interact with the product. The design of medical devices requires particular attention to good HFE practice, due to the complexity and variability of their environments of use; the need to gain regulatory approval on HFE practice before the device can be used; and the high-risk role that devices play in diagnosing and treating patients who may be suffering from severe medical conditions. Indeed, it is likely that failures to employ good HFE practice result in a significant number of cases of patient harm when using medical devices each year.