During the project, RUBYnanomed has worked in the development of a new version of its technology platform towards achieving Milestone MM1 “Beta prototype and pre-series ready for clinical validation” and its regulatory approval towards achieving Milestone MM2 “IVD product ready”. The BRIGHT project successfully enabled the transition of the RUBYchip™ platform from a laboratory prototype to a production-ready, clinically validated system. The work focused on industrialisation, performance optimisation, quality assurance, and design refinement, ensuring compliance with ISO 13485 standards and supporting future CE-IVDR and FDA regulatory pathways.
The industrialisation phase was carried out in close collaboration with key partners, including foundries, subcontractors, and specialised service providers with extensive experience in the IVD sector. These collaborations ensured the robustness, scalability, and performance of all system components while aligning development with stringent regulatory requirements. A comprehensive set of industrialisation requirements was defined and subsequently implemented through the establishment of a large-scale manufacturing process for the RUBYchip, during which multiple geometries were designed and tested.
Significant advancements were achieved in the design of key consumables. The RUBYchip® was successfully redesigned, transitioning from a COP-based structure to a PDMS–glass architecture. This modification addressed prior limitations related to long-term stability and fluidic wetting, while enabling more reliable, leak-free tubing connections due to the elastomeric properties of PDMS. In parallel, the disposable cartridge was improved with enhanced ergonomics, including the addition of a dedicated handling tab suitable for gloved users, and design adjustments to ensure optimal interaction with the automated system’s valves for reliable sample processing.
On the instrumentation side, major developments led to the creation of a functional automated processing unit. Initial alpha prototypes were developed and validated, followed by a beta prototype capable of independently processing blood samples and handling up to four RUBYchips® simultaneously. Two engineering verification units were manufactured to support regulatory testing and preparation for upcoming clinical trials. Automation was further strengthened through the integration of advanced imaging and analysis capabilities. The OEM Allegro Plus system from Bioview was successfully adapted to enable high-throughput fluorescence analysis of the redesigned chips. Given the requirement to image through a glass substrate, new positioning, scanning routines, and safety measures were implemented to ensure stability, precise objective alignment, and accurate imaging of up to eight chips simultaneously.
