Background
Based in Cambridge, Cyted provide novel diagnostic tests to drive the earlier detection of cancer. Using sampling technologies and AI-driven biomarkers they aim to unlock clinical insights and improve patient outcomes and access.
Cyted uses unique AI-driven diagnostics to identify patients at risk of developing cancer. Their cancer detecting technology provides a quicker, more comfortable and more accessible way to identify those at risk of oesophageal cancer than the current standard of care, which relies on endoscopy. Through their unique clinical pathway and biomarker data platform, they are positioned to change the patient journey for upper gastrointestinal (GI) disease management.
Every year, over 5 million people are diagnosed with cancer in their digestive system.
Understanding the problem
Cyted’s capsule sponge test is based on a simple cell sampling mechanism using a capsule that is swallowed by the patient. The capsule dissolves in the stomach releasing a sponge which upon retrieval collects cells from the oesophagus in a process that takes less than ten minutes. It can be used to monitor patients suffering from chronic heartburn and Barrett’s oesophagus, who are at risk of developing oesophageal cancer, to ensure early detection and potential treatment. The procedure is performed on conscious patients by a nurse in a clinical setting and the sample then sent to the Cyted laboratories for analysis. Cyted approached eg to generate innovative ideas to optimise the full process and improve upon the way the test was administered using an applicator.
Designing a solution
This project required in depth knowledge and navigation of the patent landscape as we were developing a device which enhanced the clinical pathway, without drastically changing it. We provided the client with user study guides which were used to conduct the studies and gain an understanding of user requirements. The aim was to design a single-use applicator which was easy to hold, comfortable for the patient and reliably dispensed the capsule, housing the thread and sponge. With a target user and problem statement in mind, we were able to provide Cyted with a number of concepts and then work with them to identify the preferred solution.
Cyted’s tests are more comfortable and accessible than conducting endoscopies
Engineering the Solution
Our previous experience in designing a range of delivery devices, including auto-injectors was instrumental in our approach to this project. Having created detailed user and product specifications, we generated a series of concepts for the device. We prepared a risk management plan and conducted a design FMEA to identify possible failure modes and resulting risks to the user(s). We then cycled through prototyping stages in order to ensure risks were addressed and usability insights incorporated resulting in a small, robust attachment mechanism for the sponge and string in a patent-heavy landscape.
During the follow-on phases of this project, our industrial design team incorporated feedback from the user studies to develop a robust, single-use, cost-effective applicator. Ergonomics – incorporating how the applicator is held, button positions and the degree of haptic feedback – were heavily incorporated. Clinicians specified that they would like to be able to inspect the capsule for any defects prior to administration, so we engineered a transparent applicator, with branded details.
Prototypes were produced throughout the project to de-risk key aspects of the development process. Space model 3D prints were tested with user groups to ensure that the design elements were suitable and the mechanism worked correctly. Following this, high quality, pre-production prototypes were produced to give a realistic representation of the look.
Our understanding of the manufacture and assembly process meant that during the design of the attractive, single-use applicator, we naturally considered how assembly sequences, robustness and tolerances would be accommodated. Ensuring the end product was easy to manufacture, assemble and test was integral to keeping the device cost down.
A variety of prototyping methods are used across the development process to de-risk different elements of the design.
End Result
Following the multiphase programme, we provided Cyted with a number of beta-prototypes and the required manufacturing documentation in order to commission mould tools and applicator parts from their chosen manufacturer. We supported them with initial testing, verification and validation throughout the development process, whilst supporting with design refinements that were required for manufacture.
Through this development, Cyted was able to launch the EndoSign® capsule sponge test to market within a constrained time period. The UKCA and CE-marked diagnostic device – which will be deployed in both clinical and community settings – could save the NHS millions of pounds as well as significantly reduce endoscopy waiting lists. An independent report from Unity Insights calculated that a single NHS Integrated Care System, of which there are 42 in total, could save as much as £3.86m over five years by adopting the technology.
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.
Further examples of our work in MedTech
Every project we work on is tailored to the needs of our clients. This extends to their privacy requirements and as such this selection of case studies includes those which our clients are happy for us to share. For more information, please get in touch.
