Essentials of usability engineering in point-of-care devices

When developing novel technologies for point-of-care medical devices it is important to keep in mind that use errors are a significant source of harm to patients. Some have estimated that a third of medical device incident reports to the US Food and Drug Administration involved use error. In order to make these novel point-of-care devices effective in developing countries, engineers must carefully consider usability engineering for distinct use environments and user populations unique to that country. The usability engineering process is a common-sense structured approach that is recognized by both US and international regulatory bodies. Key elements of the process include planning, obtaining feedback from real or simulated users in real or simulated environments, carefully considering risks due to use error and mitigating these risks, leveraging well known research in anthropometry, cognitive and behavioral sciences, and usability validation studies. Usability engineering should be applied intentionally to minimize the use errors that can reduce the effectiveness of introducing point-of-care healthcare technologies into both developed and developing countries.