The project finalized the product development of the two product components (disposable sensor and reusable monitor).This included product development of said components, as well as full verification activities that confirm that the results of the development process were in line with the requirements. Additionally, the system underwent usability and clinical validation activities.
A number of technical problems had to be solved. On the sensor it was necessary to minimise or remove storage degradation, variability, drift, biochemical interferences, and readiness time resulting in a disposable product with a one year lifetime and a one point calibration. The focus on the monitor development were the electrical safety aspects and the signal and data processing. Additionally, signal and data processing needed to be done in real-time. Finally the entire system had to be compliant with critical standards.
The final system was tested with users in a usability trial, in animal trials and in a clinical trial on ICU patients. At the end of the project the trial was still ongoing, although preliminary results were above expectations.
In addition to system safety and performance, the project focused on manufacturability; manufacturing sprints were done throughout the project period, to ensure yield stayed high (≥90%) despite technical optimization of the sensor, and that labour time per sensor went down.
During the project three patent applications have been submitted. These form an important basis for the commercialization of the technology. The patents have been reviewed by the European patent office and only minor modifications had to be done for the PCT applications. A fourth patent application was not ready for submission by the end of the project.
An important achievement in the project was a financing round led by venture capitalist investors. This equity financing was critical to the success of the project.
