There is a clear and urgent need for the development, provision and widespread use of affordable, portable, reliable and rapid Point-of-Care (PoC) diagnostic devices, especially for early diagnosis of diseases, so as to enable time-sensitive, life-saving therapeutic interventions. The intrinsic advantages of miniaturization and integration from microfluidics and Lab-on-a-Chip (LoC) devices has seldom been translated into commercial products due to various challenges. M3DLoC has established a hybrid manufacturing pilot production line, to link flexible micro-fabrication and multi-material use, aiming to address challenges in PoC diagnostics. This hybrid manufacturing process enables the fabrication of high aspect ratio microfluidic features on polymer substrates with high accuracy and repeatability, while conductive functional components of micro-structured carbon-based electrodes by inkjet printing technology with pico-litre dispensing capabilities. The conclusions of M3DLoC include:
- An innovative pilot line for advanced manufacturing of affordable and scalable microfluidic MEMS for LoC and sensing applications was established.The modules are:
- Industrial extrusion-based 3D printer with multi-material capabilities a four times production capacity, utilising synchronised printing heads.
- Micro-milling system with a high-precision positioner for the high-speed spindle for small-scale fabrication and low surface roughness.
- Inkjet deposition system with multi-material capability using 8 distinct nozzles, utilizing a proprietary non-contact acoustic technology.
- Laser modules, for polishing and surface texturing through ablation, employed for reduction of surface roughness and the creation of high-resolution features, for structures down to 11μm.
- In-line X-ray laminography and radioscopy platform for inspection and QA, utilising a novel image analysis algorithms.
- Microwave probe microscopy for nanoscale material evaluation.
- System integration through bespoke automated transport system, together with tailored software with scheduling capabilities.
- Demonstration of a low-cost alternative to ultra-precision machine tools for micro-machining and multi-material use.
- Demonstration of cutting-edge technologies and functional (nano)materials in industry-relevant applications.
- Clinical sample measurements showcasing the performance of devices produced using the pilot line, with detection protocols and assay processes that were developed in the project for viral (HIV, SARS-CoV-2), bacterial (drug resistant Tuberculosis bacterial strains) and cancer biomarker (epidermal growth factor receptor mutations).
The case studies demonstrated the feasibility of the design, materials and manufacturing technologies and their relevancy for the PoC diagnostic market. The pilot line is available for end-users requiring a microfabrication facility in an industrial setting for the pilot fabrication of medical devices, allowing the development and validation of new products, filling the gap between R&D and pre-commercial production, which can subsequently be transferred to mass production technologies.
