JMIR Publications

ABSTRACT

Background:

Errors while using medical devices, owing to flaws in the user interface design and implementation, can be a risk for users. Accordingly, increasing emphasis is being placed on usability evaluations by actual users in the design and development stages of medical devices to minimize the risk factors that may cause usage errors. Moreover, a usability evaluation is a mandatory requirement for medical device regulations in countries that follow the IEC 60601-1 standard.

Objective:

This study aimed to conduct a formative evaluation using focus group interviews (FGIs) and satisfaction surveys with healthcare professionals in the field of rehabilitation medicine to identify areas for improvement to enhance the safety and convenience of an electrically-powered orthopedic exerciser, a lower-extremity medical rehabilitation device, in the prototype stage.

Methods:

Quantitative and qualitative data were collected through formative evaluation conducted using FGIs and satisfaction surveys with participants; participants consisted of rehabilitation doctors (n=5) and physical therapists (n=5) with experience in using similar medical devices.

Results:

During the formative evaluation, the following three categories were derived to reduce exerciser usage errors: 1) product upgrades to ensure safety, 2) hardware and software improvements for convenience of use, and 3) improvement of the manual for better identifiability and understanding of the product and instructions.

Conclusions:

Improvement areas to ensure safety, convenience of use, and clarity of instructions were identified through a formative evaluation based on FGIs and satisfaction surveys with healthcare professionals with experience in using similar medical devices. The factors derived from this formative evaluation are expected to contribute to the development of an improved electrically-powered orthopedic exerciser, and repeated formative and summative evaluations of the improved version will eventually lead to the development of a safe medical device.