Sector
Background
One in five children is affected by poor eyesight, and in extreme cases, delays in treatment can lead to loss of sight. Early detection through screening allows many problems to be treated with glasses or patches to avoid future complications. Currently, eye tests are conducted in a clinical setting such as an optician’s office or hospital clinic, and require expensive, bulky equipment. However, there is an increasing need for portable solutions for use in mobile clinics or schools.
The Challenge
The DigiVis app platform was devised by ophthalmologist Louise Allen, working alongside the Paediatric Ophthalmology Team at Addenbrooke’s Hospital. She was keen to address the screening issue by leveraging advances in mobile imaging and connectivity technology. The aim was a platform to screen people’s vision, and eventually also hearing, without the use of expensive, bespoke equipment or training. eg technology were appointed to develop their idea from concept generation through to prototyping. The app was initially targeted for use with children, to be rapidly followed by 16-30 year olds. In many cases, the screening process would be guided by teachers or parents, so ease of use was key and the test needed to be short and engaging, capable of holding the attention of a child, to maximise the accuracy of results. Because schools and many other settings have either poor signal or locked-down WiFi networks, the app had to work independently. There was the usual, obvious requirement for the application to be fully compliant to all of the required standards in order to achieve CE Marking as a medical diagnostic.
| Requirement for a simple, highly intuitive user interface, designed to maximise engagement with children |
| Prototype tested to IEC 60601, IEC 62304, ISO 3897 & ISO 8235. Developed in accordance with ISO 13485 & ISO 14971 |
| Fully-managed & integrated, multi-disciplinary project with emphasis on software engineering |
Our Approach
eg technology undertook the entire end-to-end development of the DigiVis prototype app, from initial concept design and support with early phase funding initiatives through to proof-of-concept and usability testing in CUH. Acting as a fully outsourced engineering resource, our software and mechanical engineering teams worked together on a clearly defined, phased development programme to meet clinical and business goals. Extensive research of scientific papers, medical journals and regulatory standards was undertaken to gain a thorough understanding of best practice and the limitations of existing visual testing techniques.
We carried out informal usability testing and detailed risk analysis, through which we formulated both the User and Product Requirement Specifications. Our team developed the software using Microsoft tools on Surface Pros and designed the app to be cross-platform to facilitate future migration to iOS.
Full documentation was provided to the client throughout the programme, and early phases supported their funding initiatives.
Our Results
The Paediatric Ophthalmology Team at Addenbrookes were able to leverage our extensive experience in User Interface (UI) storyboarding and app development. The DigiVis prototype we created was developed in accordance with ISO 13485 & ISO 14971, and meets the requirements of IEC 60601, IEC 62304, ISO 3897 & ISO 8235.
Following our proof concept prototypes and with the technology proven, DigiVis went on to further expand their suite to incorporate audiometry screening. It was also extended for online use with a laptop and phone to help address “remote requirements” caused by the Covid-19 pandemic. The current DigiVis device has been used by Cambridgeshire Community Trust as a “catch-up” screening programme for approximately 10,000 four to five-year-old children across the country, who missed vision screening.
DigiVis and the Paediatric Ophthalmology Team at Addenbrookes were recently awarded the Discovery and Advances in Healthcare prize at the inaugural CUH awards 2022, as well as the innovation prizes of the Royal College of Ophthalmologist’s Congress 2021 and the British and Irish Paediatric Ophthalmology and Strabismus Association Conference 2021.
Are you ready to develop your product or idea?
For further information on how eg technology can support in getting your technology or ideas to market or to chat with one of the eg team about your product design and development requirements, please get in touch.
