Truscreen

Designing a cervical cancer screening technology.

A Global Demand for a breakthrough device

The Global Cancer Screening market is estimated to be worth more than AUD$3 billion per annum. With 500k new cases and 250k deaths, it is estimated that 90% of those deaths occur in developing countries. TruScreen founders were holding the pieces to a puzzle that could aid one of the deadliest health issues affecting women worldwide. A traditional Pap test that can take weeks to deliver a diagnosis. TruScreen’s technology accurately detects pre-cancerous and cancerous cervical cells and provides immediate, precise results. TruScreen’s technology works by detecting pre-cancerous change, or cervical intraepithelial neoplasia (CIN), by optical and electrical measurements of cervical tissue. The system uses low levels of electricity and light to examine the cervix. Unlike a Pap test, tissue samples are not collected, which minimises discomfort and increases the likelihood the patient will return for a repeat screen.

Entrepreneurship-led Design

The first iteration of the device was positively received but also faced a significant number of challenges. Developed as two part system, a wand and cradle connected by a long cord, the product had proved unwieldy and cumbersome in high volume testing scenarios with limited opportunity for digital integration. As the demand from specialists around the globe intensified, it became clear the device needed to adapt.

In February 2014, IDE took on the challenge to develop TruScreen’s next generation product. TruScreen wanted to develop a product that could disrupt the market and drive the company’s next wave of accelerated growth.

CEO Martin Dillon said the new device was the result of an 18 month ‘miniaturisation and mobilisation’ program to address customers’ increasing demand for integration and usability. To achieve this, TruScreen needed to move the entire technology into one single, compact, handheld device and fit the new needs of the market through improved appearance & functionality. Most importantly, the device needed to be comfortable and easy to hold, incorporate wireless connectivity, wireless charging and touch screen technology.

Big challenges, bigger rewards

IDE researched other devices to investigate alternative ergonomics. Working in partnership with Truscreen, the team proposed a design that emphasised ergonomics. The the final concept was tested on-site with a Medical Advisory Committee consisting of prominent colposcopic surgeons. Clinical feedback confirmed and validated the final design.

Manufacturing @IDE

TruScreen considered IDE as a trusted entrepreneurial partner and was confident IDE had the capability to deliver the product in a quality assured way consistent with ISO 13485 certification. Halfway through the project, TruScreen asked IDE to take on the challenge and responsibility of manufacturing and delivering the product.

A key challenge was coordinating both the technical aspects of production whilst addressing issues arising from external stakeholders across multidisciplinary teams. “Since IDE operates internally as a multidisciplinary team incorporating the design and development of electronics and software, the team had been there before and knew the right questions to ask” said Richard Sokolov, the Product realisation Director at IDE Group.

Accelerating the commercialisation process, we took advantage of our fully developed supply chain and ensured the design team was in regular and consistent contact with resources developing the optical front end. IDE quickly locked in their capability to assemble all of the parts for the electronics and optics in a clean and open production space on-site at The Connectory. This provided TruScreen and their investors added confidence that each product would be assembled, monitored and checked by the team to ensure the highest quality standards were maintained.

IDE’s continued partnership with TruScreen looks forward to keep making an important positive contribution to health of women worldwide.