The final prototype series is completed, ready to be used in clinical validation studies
The optical path, the precision mechanics have been almost fully industrialized. The final drawings in Solidworks format, the technology instructions and the machining center programmes have been developed. The modifications that will prove necessary during the final industrialization process will be now much easier and faster to execute and document. The purchased optical element suppliers are now chosen, following a careful selection and test of several sources (camera, objective, filters). The objective holding/moving mechanism and drive has been completely redesigned, in line with the current dedicated slide design and the resulting Z movement need during the focus plane search.
The hardware has been completely redesigned, the topology has been changed from a central PCB – sensor/motor configuration to a modular, bus backbone master-slave configuration. The 6 slave distributed intelligence PCBs are much easier to be produced, as they are almost identical, and this structure significantly simplifies the internal cabling and thus reduces noise sensitivity. This of course involved the rewriting of the related firmware completely. The only DC motor used in the previous generation has been replaced to decrease the number of technologies used and to allow selection of a smaller number of suppliers.
Certain crucial algorithms of the artificial intelligence software have been completely rewritten, or completed. The new contour detection, skeleton detection, sub-pixel based algorithms are significantly more robust and sensitive then the previous version. By adding computing power with a more powerful All In One computer, the processing time of this much more sophisticated algorithm still fits within the timeframe of the mechanical movement, integration time window, thus allowing for maximal throughput. The internal QC test completed with 131 samples and confirmed both by manual fluorescent microscopy and culture results have produced extremely promising results.
And finally the test production batch of our latest design of the dedicated slide has also arrived from our partner in Bombay, Florotek Biosystems. This considerably decreases the number of problems to be handled by the mechanics due to the huge spread in dimensions of commercial slides and helps the optical path in determining the correct focus plane on a negative sample as well, in a well defined and reproducible way.
During the production, the assembly, the adjustment of the three prototypes, we have obtained valuable experiences for the slight modifications and dedicated tools to be designed, for the planned final production test batch, to ease the process of final assembly and QC. As the mechanical/optical module contains almost 400 individual components, this is a valuable pool of information to speed up the setup of mass production. The Things-To-Do list needed for the last phase of the development before mass production – the industrialization phase – is now open.
The three identical prototypes are now ready to be used in clinical validations, in demonstrations and to be shown to the public and the industry.