Usability engineering in practice: developing an intervention for post-stroke therapy during a global pandemic

Abstract

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. Presented is an outline and discussion of the challenges experienced in developing the SHAPES health technology intended for at-home use by stroke survivors and in implementing usability engineering approaches. Also highlighted, are the benefits that arose, which can offer easier involvement of vulnerable users and add flexibility in the ways that user feedback is sought. Challenges included: restricted travel; access to usual prototyping facilities; social distancing; infection prevention and control; availability of components; and changing work pressures and demands. Whereas benefits include: less travel; less time commitment; and greater scope for participants with restricted mobility to participate in the process. The paper advocates a more flexible approach to usability engineering and outlines the onward path for development and trialling of the SHAPES technology.

Keywords:

• Stroke
• stroke therapy
• usability engineering
• SHAPES
• intervention

Acknowledgements

The authors wish to acknowledge the team members, users and stakeholders who have shared their time, views and experiences during the evolution and delivery of the Sheffield Adaptive Patterned Electrical Stimulation (SHAPES) project.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Additional information

Funding

The SHAPES project is funded by the National Institute for Health Research (NIHR) Invention for Innovation (i4i) programme [ref: NIHR201642]. Professor Tindale is the Clinical Director of, and Dr McCarthy and Professor Moody are Theme Leads for, the National Institute for Health Research (NIHR) Devices for Dignity MedTech Co-operative. The Devices for Dignity MedTech Co-operative is funded by the National Institute for Health Research. Dr Nair receives support from the NIHR Sheffield Biomedical Research Centre and The Insigneo Institute for in silico Medicine. The views expressed are those of the authors and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health and Social Care.