Human factors engineering is focused on the user (ergonomics) and the use (usability) of medical devices. The utilisation of medical devices in hospital and home environments is on the rise due to the current economic and demographic challenges: ageing population, technology advancements and attempts to reduce the healthcare costs. It is usually overlooked that use error is everyone’s responsibility and in order to design a successful medical device, one must meet the requirements of the manufacturer, regulatory bodies, healthcare provider, but also of the end user.
Usability (or user) studies offer an insight into use-related errors; this is achieved by evaluating the user interface: how does the user interact with the medical device? At MD-TEC, we ensure that we engage representative end users in realistic scenarios and environments while operating the medical device, hence their feedback is highly relevant for medical device improvement. Depending on the development stage of the medical device, a usability study can vary between focus groups, iterative improvement and validation.
By performing usability studies, the manufacturer can assure medical device safety and suitability for lay users, healthcare professionals or patients. Both quantitative e.g. success rate, number of errors, and qualitative data e.g. 1:1 interview, questionnaire, are essential in order to identify areas for improvement. Finally, use-related errors can be mitigated via medical device design, protective measures, packaging, labelling or instructions for use. Our team can make you further recommendations in this sense and help you design an efficient and intuitive user interface.