Abstract
The majority of commercially oriented microfluidic technologies provide novel point-of-use solutions for laboratory automation with important areas in the context of the life sciences such as health care, biopharma, veterinary medicine and agrifood as well as for monitoring of the environment, infrastructures and industrial processes. Such systems are often composed of a modular setup exhibiting an instrument accommodating rather conventional actuation, detection and control units which interfaces with a fluidically integrated “Lab-on-a-Chip” device handling (bio-)sample(s) and reagents. As the complex network of tiny channels, chambers and surface-functionalised zones can typically not be properly cleaned and regenerated, these microfluidic chips are mostly devised as single-use disposables. The availability of cost-efficient materials and associated structuring, functionalisation and assembly schemes thus represents a key ingredient along the commercialisation pipeline and will be a first focus of this work. Furthermore, and owing to their innate variability, investigations on biosamples mostly require the acquisition of statistically relevant datasets. Consequently, intermediate numbers of consistently performing chips are already needed during application development; to mitigate the potential pitfalls of technology migration and to facilitate regulatory compliance of the end products, manufacture of such pilot series should widely follow larger-scale production schemes. To expedite and de-risk the development of commercially relevant microfluidic systems towards high Technology Readiness Levels (TRLs), we illustrate a streamlined, manufacturing-centric platform approach employing the paradigms of tolerance-forgiving Design-for-Manufacture (DfM) and Readiness for Scale-up (RfS) from prototyping to intermediate pilot series and eventual mass fabrication. Learning from mature industries, we further propose pursuing a platform approach incorporating aspects of standardisation in terms of specification, design rules and testing methods for materials, components, interfaces, and operational procedures; this coherent strategy will foster the emergence of dedicated commercial supply chains and also improve the economic viability of Lab-on-a-Chip systems often targeting smaller niche markets by synergistically bundling technology development.
Highlights
Since their inception between the late 1970s and early 1990s [1,2,3], the field of microfluidics has tremendously advanced from creating sheer miniaturised versions of conventional pumps, valves and analytical equipment to harnessing specific, typically micro-confinement-related effects that enable a broad repertoire of novel applications
Cost reduction and packaging seem to be amongst the main industry drivers for MEMS. While it is a prerequisite for higher-level functional integration of Lab-on-a-Chip applications, miniaturisation is generally considered to hit technological boundaries even earlier than MEMS; one of the fundamental reasons for this restraint is constituted by basic hydrodynamics leading to a massive reduction of the flow rate with the channel cross section and the related technical challenge of its fine control; other severe roadblocks might be hitting the limits of detection for shrinking volumes
While microfluidic technologies have been developed over approximately three decades, true killer apps have not surfaced
Summary
Since their inception between the late 1970s and early 1990s [1,2,3], the field of microfluidics has tremendously advanced from creating sheer miniaturised versions of conventional pumps, valves and analytical equipment to harnessing (and managing) specific, typically micro-confinement-related effects that enable a broad repertoire of novel applications. The lion’s share of this market is related to microfluidics-enabled products for decentralized, fully automated preparations and/or (bio-)analytical testing as addressed in this work [7]. This work considers a significant subset of micro-fluidic technologies for automating and parallelising liquid handling protocols comprising sample preparation, reagent management and/or detection as the backbone of common bioanalytical laboratory procedures. Such technologies frequently involve a modular setup made of a single-use polymer microfluidic chip interfacing with a reusable instrument. Successful commercialisation of microfluidic technologies is tightly coupled to the operational performance, robustness, development and manufacturing cost of the disposable, usually a microstructured and fluidically sealed polymeric chip
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