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Commercialisation of dental medical device for measuring salivary pH

Periodic Reporting for period 1 - Medika (Commercialisation of dental medical device for measuring salivary pH)

Reporting period: 2018-08-01 to 2019-01-31

Oral hygiene is very important for health and well-being of humans. The global market of home dental hygiene products is more than 30 billion USD world-wide, with an estimated increase of 8% annually (CAGR). Several recent studies have proved that salivary pH is a diagnostic biomarker of oral and even some gastroenterological diseases. The deviation of salivary pH from the normal value of ±7.2 indicates pathological status. However, the self-measurement of salivary pH is very difficult, even impossible, since no device is commercialised for this purpose. Salivary pH is now usually measured from spittle using pH indicator paper (lacmus which is toxic if placed into the mouth). This measurement is not accurate enough, and difficult to carry out by patients at home. We have designed and developed an easy-to use medical device for measuring the salivary pH in the mouth. The new device is revolutionary, ergonomic, have data storage and transfer capabilities, connection to smart devices, accurate (0.1 pH), ball-pen-sized and accessible for the visually impaired (Braille writing). We have protected the design and participated in several start-up events, where we won different local awards. The Medika device is ground-breaking, creating new market, as it will be the first self-measurement device for measuring salivary pH at home. As a medical device (with official certification) it will help dentists to measure and record the pH of saliva for large number of patients routinely and remotely before and after dental surgery. Its use by the wide public will prevent or avoid worsening of several oral and gastroenterological diseases. The aim of the phase 1 project was to make a feasibility study for both the technical and business development actions planned for the commercialisation of the Medika device: to specify the software and the prototype, to prepare for clinical validation, to refine our business plan and to prepare the project plan for an SME Instrument Phase 2 application.
We examined the technological and business feasibility of Medika device, and we assessed the relevant risks of our project development. First, we further improved the prototype based on our continuous consultation with dental experts. Our method now makes better representation of samples while the new design and the sensor unit are more ergonomic, and their serial production is easier. Upon these modifications we have made a more precise estimation on the production costs that was fed into our commercialization plan. We have negotiated with potential manufacturing partners for initiating the trial production and chosen a company which manufactured Medika Pro for conducting further trials. Parallel to the hardware development, we made a detailed specification for the mobile application, prepared a plan for clinical validation and negotiated with potential test sites. We carried out a market survey including a customer behaviour study based on interviews with practitioners (dentists, oral surgeons, general doctors). We have further detailed our business plan that includes risk analysis, company development strategy and product line extension possibilities. Based on the results, we concluded that our project is technologically feasible and economically reliable, therefore we shall continue our work to make a dynamic market entry with the Medika devices in Europe and worldwide. We made detailed plan for an EIC SME Instrument Phase 2 proposal.
Our proposed product is ground-breaking, as no self-measurement device is available for home measurement of salivary pH today. Our product would be revolutionary and will create a new market. We shall continuously promote the technology at medical forums and increase public awareness through propagative campaigns the importance of salivary pH control. These actions will promote the generation of the new market. Upon the completion of a Phase 2 project it is expected that Medika Pro will enter the market niche that has not been covered yet. The solution will help maintain a good oral hygiene and will also assist practitioners and patients in the prevention and early-stage diagnosis of periodontal and other common diseases of our society. Regarding our company, the success of the project would promote our growth, reaching expectedly 14.5 million euros revenue, 4.6 million euros of profit and create 130 new jobs by 2025.
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