Currently submitted to: JMIR Formative Research
Date Submitted: Nov 3, 2024
Open Peer Review Period: Nov 3, 2024 - Dec 29, 2024
(currently open for review)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Usability Testing of Medical Device Based on Virtual Reality-Based Upper Limb Rehabilitation Software through Cognitive Walkthrough
ABSTRACT
Background:
Intuitively recognizing risk factors caused by using software as a medical device is difficult because the interaction between the user and medical devices occurs in a virtual space. Therefore, user safety must be secured through usability enhancement using usability tests.
Objective:
A formative evaluation was conducted to derive improvements in the usability and safety of virtual reality-based upper-limb rehabilitation software as a medical device in its prototype stage.
Methods:
A formative evaluation was conducted using a cognitive walkthrough and survey. Occupational therapists (n = 6) who had some experience using medical devices similar to the upper limb rehabilitation software participated in the test, and quantitative and qualitative data were collected.
Results:
Through formative evaluation, the following possible improvements in usability and safety were identified for the upper-limb rehabilitation software: 1) graphical user interface improvements for convenience of use, 2) natural user interface improvements, and 3) improvements in the user manual for better identification and understanding of product information and instructions.
Conclusions:
The factors derived from this usability test will lead to improved upper-limb rehabilitation software, and better usability and safety of the product will be guaranteed by conducting formative and summative evaluations
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