Towards industrialisation of microfluidic sample-to-answer solutions enabling point-of-use testing of biosamples: A design-for-manufacture LED platform approach

The commercial development of many microfluidics-enabled commercial devices requires rapid, optimization and cost-efficient development of competitively priced, and still very rugged, mostly single-use devices. A key challenge remains the seamless scale-up of manufacture from laborious prototyping techniques based on low-throughput machinery and frequently expensive materials to pilot series and industrializable (polymer) mass replication, (bio-)functionalization and assembly schemes. Furthermore, the timescales and budgets involved from idea to product are often hard to accept for investors, in particular when considering that many microfluidics-based products will, at least initially, be restricted to comparatively small niche markets or rather tiny fractions of larger markets; hence, economy-of-scale effects are difficult to reach for recovering (sunk) for research and technology development as well as set up of manufacture. This paper presents a platform approach adopted from many mature industries like automotive or microelectronics for assuring cost-efficient, significantly expedited development of process integrated and automated, microfluidics-enabled solutions at high technology readiness levels (TRLs) with typical application in decentralized ""point-of-use"" handling and testing of biosamples. Key paradigms supporting this platform approach towards industrialization of microfluidics-enabled solutions are design-for-manufacture (DfM) for seamless scale-up from prototyping to production, quality-by-design (QbD) for robust operation and readiness for scale-up (RfS) towards mass fabrication.