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TruScreen
Client
Category
MedTech - ISO 13485
Services
Regulatory Compliance
Every 2 minutes, a woman dies from cervical cancer. Of the 600,000 people diagnosed every year around half die, even though cervical cancer is a largely preventable disease. Countries with effective screening programs are able to greatly reduce mortality rates. However, screening using traditional methods, such as Pap testing, requires substantial infrastructure, highly trained human resources, and robust quality assurance processes. Almost 90% of global deaths occur in low and middle income countries with poor infrastructure. TruScreen provides an alternative screening solution that addresses these barriers and delivers real-time detection of pre-cancerous and cancerous cervical cells.
The TruScreen device uses optical and electrical sensors to gather data on a patient’s tissue at multiple points on the cervix. An AI-enabled algorithm then analyses the data, comparing it to known tissue signatures to provide an immediate “Normal” or “Abnormal” result. This enables the physician to immediately plan appropriate patient care. The handset includes a touchscreen display to operate the device and read results immediately, as well as wireless connectivity to download information for export into other systems.
Genesys took the bulky first-generation product and turned it into a sleek and easy to use system with an integrated charging dock. A key challenge was to maintain diagnostic integrity from the first-generation device in order to minimise commercial and regulatory risks in the transition. However, being wireless and battery powered, as well as having a wider memory range, the system had to be reengineered for the new configuration. Genesys redesigned the circuitry to reduce power consumption and to integrate a Wi-Fi module. Industrial design for this project was delivered by IDE Group.
Since the product was launched in 2016, Genesys has made continual improvements to the device. Genesys has provided ongoing support including the implementation of new features such as reducing the time required to recharge the unit's internal battery, and implementing automated self-calibration of optical characteristics to extend the time between factory re-calibration events.
Production support was also supplied including the streamlining of manufacturing processes, addressing occasional component end-of-life issues and substituting components to address global chip shortages. More recently the cybersecurity of the device has been upgraded, in line with newly released standards and increasingly stringent requirements of regulatory authorities.
A key service has been the implementation of multiple language versions of the graphic user interface as TruScreen entered new markets, including Chinese, Vietnamese, Russian and Spanish. Challenges addressed include dealing with the limited string length on the display and the need to incorporate language glyph sets into the device's embedded software.
A world without cervical cancer
Image: Key TruScreen people, courtesy of its 2023 AGM presentation
Martin Dillon, former CEO of TruScreen during the project, said “We sought a partner with the required electronics, software and embedded software skills required to help us modernise TruScreen. After looking at several options, we chose Genesys Electronics Design due to their expertise, responsiveness and exceptional internal quality assurance program.
“We were highly impressed with Genesys Electronics Design. From our first engagement to delivery of the final product, their ability to understand the requirements and adapt everything to fit was brilliant, as was their ability to quickly locate and rectify any minor flaws during the testing process.”
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