The product design was improved based on inputs on the external setup, functionality, manufacturability, and performance in order to bring the design to a level that the product will function and look as commercial product. Components were tested for functionality, mechanically and in the usability aspect. In the communication process, we successfully examined its two most important indicators, which are: time and the percentage of lost signal frames. As the greatest value provided by the Neuroon-MED system is the biological data collected during sleep from the patient at home - it is absolutely crucial that the data loss in the transmission process has to be minimal.
We have developed all individual modules of our innovative system that have been successfully tested and prepared for implementation in the final device. As our system consists of several devices, we have implemented a global time synchronization, thanks to which all collected data does not have time stamps shifted. Synchronization is performed by the docking station wirelessly at a fixed time interval. We have implemented a special module for estimating the energy consumption planned for the upcoming test to avoid the situation of discharge of the device during the test and data loss.
Based on long research on every aspect of physiological measurements at home and constant contact with doctors, we developed a complete system prototype that meets the latest telemedicine standards. A device was created, whose dimensions are the smallest on the market, which was refined not only in technical terms, but also in terms of ergonomics.
An optimal production process has been developed from scratch to ensure successful production. We have realized a pilot production of 100 devices with 98% efficiency and a production reject of no more than 2%.
We have analyzed the currently applicable certification standards and prepared the required documentation and samples for testing.
The design of our final device have received a positive opinion from the Bioethics Committee of the Institute of Psychiatry and Neurology in Warsaw, Poland.
The clinical study model of our system has been successfully defined. Patients and volunteers recruitment/exclusion criteria, confidentially agreements, consent forms, and participant remuneration have been set. The purpose of the clinical study was to compare the automatically scored NeuroOn-MED results (nRDI) to the manually scored polysomnography RDI (PSG-RDI). The NeuroOn and polysomnography data have been recorded simultaneously in a time-synchronization manner. Our research shows that the effectiveness of the automatic sleep analysis performed by our system is 76.36% and is comparable to the effectiveness of the assessment made by a doctor, which on average is 76.90%
In the commercialization and communication field, comprehensive market analysis and communication plan have been prepared. The plans details the strategy to communicate the development and launch of the product to ensure success of NeuroOn – MED mask and to publicize the funding received by the EU Horizon 2020 grant. As part of those activities, we attended several conferences dedicated to the problem of sleep disorders and reached broad audience using social media, mainly Facebook, our you tube channel, company’s website, video content, promotional materials. Meetings were conducted with several specialists and engineers in order to create a user community and a partner ecosystem. In the course of talks and meetings as well as in-depth market research, we were able to define our client segments better and choose the optimal way of communication for them.
A patent application has been filed that will provide protection at a general level - describing the entire Neuroon-MED system and an application providing protection at a detailed level - the most innovative part of the system, the respiratory analysis module with EOG measurement and wireless communication.
