Abstract
Stroke is the leading cause of death worldwide. Carotid artery stenosis (CAS) is an early indicator of stroke, as well as a risk factor for vascular diseases. Currently, the preferred choice among non-invasive diagnosis tools for assessing CAS severity is carotid Doppler ultrasound; however, it is impractical for use in screening. In this study, the PulStroke project was initiated in our laboratory to transform the video motion analysis (VMA) developed by the authors into a commercial product using a user-centric design approach, with the goal of completing CAS screening with ease. A user takes a 20-second video clip with the PulStroke device, and with just one simple screen touch, the video clip is recorded and automatically uploaded to a cloud server for the assessment of CAS risk. VMA analyzes the video clip, and a risk report is sent to the user's account in 5 min. This process is achieved with an automated system featuring hardware integration and streamlined operation flow via backend/frontend software architecture. This paper presents the methodology used to advance the technology readiness level from 1 to 6, highlighting the evolution of the device and method, called the PulStroke as a potential brand name, from concept to product. As part of the technology maturity evaluation, the PulStroke was tested on target users, i.e., medical and non-medical professionals, for the user experience and post-screening feedback. Most users found the PulStroke to be fully functional and easy to use, and the satisfaction rate was higher than 88 %. The PulStroke device could be incorporated into future clinical practice to provide the general public with quick and cost-effective CAS screening for the first time.