Efficient Development of Commercially Viable Lab-on-a-Chip Solutions by a Platform-Based Design-for-Manufacture Strategy

Abstract

Integrated microfluidic technologies have demonstrated significant benefits for a range of applications, mostly in the context of decentralised bioanalytical multiparameter testing at the point of use with primary applications in healthcare, pharma, veterinary medicine, agrifood and life-science research as well as monitoring of the environment, infrastructures and industrial processes. To decisively accelerate development, FPC@DCU (www.dcu.ie/fpc) - the Fraunhofer Project Centre for Embedded Bioanalytical Systems at Dublin City University, pursues a coherent, design-for-manufacture (DfM) themed platform approach; new, microfluidics-enabled sample-to-answer solutions are generated from a common library of geometrically parametrized fluidic elements for flow control, e.g. valves and routers, coordinating sequential and parallelized liquid handling protocols comprising of mixing, metering, aliquoting, reagent storage and particle removal steps. The impact of tolerances of manufactured, multi-scale geometries and materials properties experimental are considered through a Monte-Carlo simulation to advise on (fluidically) robust designs assuring operational robustness towards larger-scale (functional) integration (LSI) and automation. The entire palette of manufacturing schemes along scale-up ranging from prototyping by ultra-precision milling (UPM) to tooling / mould inserts, polymer replication (e.g. by injection molding) and system assembly are considered. The DfM paradigm thus facilitates seamless scale-up from pilot series for fluidic design optimization to bioassay development and large-scale production, thus substantially supporting regulatory approval and significantly de-risking commercial product development. This presentation will illustrate the DfM to reach high technology-readiness levels along the example of FPC@DCU's centrifugal microfluidic Lab-on-a-Disc (LoaD) platform.