Sector | MedTech
Background
Co-founded in Edinburgh by Adam Christie (CEO) and Bruce Vernon (CTO) in 2012, CALCiViS is focused on
modernising the management of dental demineralisation by providing a real-time, chair-side assessment of the
caries (dental decay) disease process. With insight from international specialists in caries and erosion, Calcivis has developed a completely novel imaging technology that enables clinicians to visualise active decay early, when it can be stopped and potentially reversed so that patients can be treated before a cavity develops that requires drilling and filling.
The CALCiViS Gen 2 device developed by eg technology is a wireless, rechargeable, handheld point-of-care device, designed to diagnose early signs of tooth decay. The system applies a patented photoprotein to the surface of the tooth which, in the presence of free calcium ions, produces a very short, low-level light flash. An integrated intraoral sensor immediately detects the luminescence (light flash) and presents clinicians with a clear demineralisation map.
Dental decay (caries) is the most prevalent and preventable disease in the world, affecting 35% of the global population.
How we developed a biotechnology-based dental imaging system through integrated design principles:
Understanding the problem
CALCiViS approached eg technology to design Gen 2 of their imaging system with a focus on reliability and cost. The brief for the initial design phase was to create an ergonomic, professional-looking, wireless, handheld device, which incorporated the existing reagent and syringe but with more reliable delivery mechanism, electronics and software, all within a smaller, more ergonomic handset.
Revolutionising the world of preventive dentistry
We needed to initially get a detailed understanding of the use-case, and the shortcomings of the existing product. This understanding allowed us to identify a problem statement around which we could structure our initial product ideation sessions.
Stepping into the user’s shoes
Although we did not carry out formal usability studies, we were able to use the pre-existing work carried out by CALCiViS to gain an understanding of the user requirements. The primary issues that needed addressing were:
- The size of the device
- The noise made by the device
- The limitations caused by the 2m cable
Therefore, the aim was to create a device which not only performed technically but was also wireless, quiet, easy to use and hygienic for the patient and operator. The main handheld part of the device needed to be easy to hold and small enough to fit comfortably in a patient’s mouth, whilst still operating within the technical parameters.
Designing a Solution
With a target user and problem statement in mind, our design team set about exploring a range of concepts. This project required complete collaboration across disciplines and as such, the initial ideation workshops involved group ideas sessions where a large number of possible solutions and features were explored. Getting creative input from the diverse team at the early stages of the project helped to ensure a broad solution map was considered. We were able to provide CALCiViS with a number of concept ideas – demonstrating our understanding of the detailed brief – and then work with them to identify the preferred solution. The project was delivered over a phased approach.
Early ideation works well with a broad, multidisciplinary team
Engineering the Solution
With a design direction identified, mechanical, electronics and software teams set about resolving the key technical challenges by developing a cohesive design. Each element of the development, be that circuit board development, optics, casework design or software, directly impacted each other, meaning that collaboration between the engineering teams was pivotal to the success of this project. As such, this device is therefore a good example of integrated product design.
One of the biggest challenges we faced involved the reagent application. It was imperative that the photoprotein was applied to the tooth’s surface in an even mist, to ensure sufficient reaction with the calcium ions. The mechanism behind this application had to be small enough not to affect the overall size of the mouthpiece (which had to fit comfortably in a patient’s mouth) and reliable, with no routine maintenance expected to be performed. Due to the very nature of the CALCiViS device, the patient contact components needed to be ‘single-patient use’ to maintain hygiene, whilst delivering the reagent and not obstructing the imaging process.
Imaging the tooth posed its own problems. The device needed to provide a live video stream under controlled, ‘white light’ illumination for the clinician to undertake their initial assessment, and then switch to a ‘dark light’ mode to capture the faint bioluminescent flash. We designed the optics system from scratch, creating a low-tolerance, compact camera, illumination and custom lens system, all controlled by adaptive software to provide optimum imaging with minimal latency. Our team used their experience in wireless connectivity to automate the device pairing and high-speed data transfer.
The industrial design team worked collaboratively with the electronics and mechanical engineers to create a casework which integrated the camera, reagent dispensing, control electronics and antenna. The attractive, hygienic handset is easy to manufacture, assemble and test, integral to keeping the device cost down.
eg technology also developed the docking station, which charges the handset and provides a temperature-controlled storage space for the reagent when not in use.
Prototypes of various types were produced to de-risk key aspects of the development process. Early in the process for instance, space model 3D prints were used to test with user groups to ensure that the size/proportions of the mechanical design elements were suitable. Towards the end of the design process, high-quality, pre-production prototypes were produced to give a realistic representation of the look.
A variety of prototyping methods are used across the development process to derisk different elements of the design
End Result
This project included key phases of technical due diligence, risk management, concept generation, proof-of-principle designs/models, alpha prototyping, beta prototyping, pre-production prototyping, informal formative testing and finally transfer to manufacture. All of this work was carried within eg’s own ISO 13485 framework and in accordance with ISO 14971, IEC 60601 and IEC 62304 regulations.
Calcivis is now setting its sights on US growth having secured pre-market approval (PMA) from the US Food and Drug Administration (FDA). As the first Scottish medical device to secure the coveted accreditation, the Calcivis Imaging System aims to revolutionise the dental sector by enabling the move to a more preventive treatment model.
CALCiViS received a commercial product for which they applied initially for FDA approval, with the aim to seek CE marking for release into the European market in due course. In 2020, eg and CALCiViS received an honourable mention at the European Design Awards for the CALCiViS oral imaging device.
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.
