We concentrated in the first month to finish the design and specifications of the MVP. This cumulates in Early Adopter Testing with one laboratory, starting in July 2020. Since then, about 50.000 samples have run through our system which delivers traceability and transparency in the customer’s daily routine.
Since the summer, our focus is on preparing the market launch with a CE-certified, GDPR compliant and scalable solution. We designed and implemented the software backend and frontend to be based on massively scalable micro-services architecture. Hardware components were transferred from prototype to industry components going through the process of industrial design and preparation for massive manufacturing with external partners.
In preparation of the market launch in early 2021 with a CE-marked product, we performed a regulatory requirement analysis with respect to MDR/IVDR and FDA, prepared the necessary technical evaluation report according to international guidelines and directives that apply (e.g. low voltage directive LVD, electromagnetic compatibility devices EMC, etc.) and technical documentation, covering every aspect relating declaration of conformity, design, performance data, safety, development and manufacture of the product.
Concerning IP rights, S4DX patent applications are in the final negotiation phase with the European Patent Office. Several registered designs and trademarks have been submitted in addition. We have done a freedom to operate search, obtaining professional search updates in 6-month steps and establishing a patent monitoring system for identification of relevant patents.
As continuous effort to monitor the performance of our system, we generated several internal reports on the usage and effectiveness of our system. The data generated by S4DX was complemented by the customer’s data to obtain wholistic picture. A journal paper has been submitted for publication to the Clinical Chemistry and Laboratory Medicine.
