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: SHAPES; Stroke; intervention; stroke therapy; usability engineering.

Figure 1.

NIHR Devices for Dignity MIC innovation process [22].

Figure 2.

Development pathway of SHAPES.

Figure 3.

Illustration of the relative size and positioning of SHAPES system in order for the treatment to be administered (stimulator in yellow, electrode array in green, arm sleeve in blue).

Figure 4.

Models created for pre-pandemic usability studies of showing different shapes and forms for the stimulator (A). Models incorporating different control options were later produced (B) [40].

Figure 5.

(A–C) Illustrative components parts.

Figure 6.

Push fit connector with additional grip as used in previous studies.

Figure 7.

Electrode array mock-ups slotted into and secured in the model stimulator.

Figure 8.

Options for stimulator control.