Avril D McCarthy, Louise Moody, Mark L Reeves, T Jamie Healey, Tim Good, Lise Sproson, Adewale Adebajo, Wendy Tindale, Krishnan Padmakumari Sivaraman Nair
This paper provides an overview of the usability engineering process and relevant standards informing the development of medical devices, together with adaptations to accommodate situations such as global pandemics where use of traditional face-to-face methods is restricted. To highlight some of those adaptations, a case study of a project developing a novel electronic rehabilitation device is referenced, which commenced in November 2020 amidst the COVID-19 pandemic. The Sheffield Adaptive Patterned Electrical Stimulation (SHAPES) project, led by Sheffield Teaching Hospitals NHS Foundation Trust (STH), aimed to design, manufacture and trial an intervention for use to treat upper arm spasticity after stroke...
August 2022: Journal of Medical Engineering & Technology