Overcoming technological barriers in microfluidics: Leakage testing.

The miniaturization of laboratory procedures for Lab-on-Chip (LoC) devices and translation to various platforms such as single cell analysis or Organ-on-Chip (OoC) systems are revolutionizing the life sciences and biomedical fields. As a result, microfluidics is becoming a viable technology for improving the quality and sensitivity of critical processes. Yet, standard test methods have not yet been established to validate basic manufacturing steps, performance, and safety of microfluidic devices. The successful development and widespread use of microfluidic technologies are greatly dependent on the community's success in establishing widely supported test protocols. A key area that requires consensus guidelines is leakage testing. There are unique challenges in preventing and detecting leaks in microfluidic systems because of their small dimensions, high surface-area to volume ratios, low flow rates, limited volumes, and relatively high-pressure differentials over short distances. Also, microfluidic devices often employ heterogenous components, including unique connectors and fluid-contacting materials, which potentially make them more susceptible to mechanical integrity failures. The differences between microfluidic systems and traditional macroscale technologies can exacerbate the impact of a leak on the performance and safety on the microscale. To support the microfluidics community efforts in product development and commercialization, it is critical to identify common aspects of leakage in microfluidic devices and standardize the corresponding safety and performance metrics. There is a need for quantitative metrics to provide quality assurance during or after the manufacturing process. It is also necessary to implement application-specific test methods to effectively characterize leakage in microfluidic systems. In this review, different methods for assessing microfluidics leaks, the benefits of using different test media and materials, and the utility of leakage testing throughout the product life cycle are discussed. Current leakage testing protocols and standard test methods that can be leveraged for characterizing leaks in microfluidic devices and potential classification strategies are also discussed. We hope that this review article will stimulate more discussions around the development of gas and liquid leakage test standards in academia and industry to facilitate device commercialization in the emerging field of microfluidics.

Accelerating innovation and commercialization through standardization of microfluidic-based medical devices.

Worldwide, the microfluidics industry has grown steadily over the last 5 years, with the market for microfluidic medical devices experiencing a compound growth rate of 22%. The number of submissions of microfluidic-based devices to regulatory agencies such as the U.S. Food & Drug Administration (FDA) has also steadily increased, creating a strong demand for the development of consistent and accessible tools for evaluating microfluidics-based devices. The microfluidics community has been slow, or even reluctant, to adopt standards and guidelines, which are needed for harmonization and for assisting academia, researchers, designers, and industry across all stages of product development. Appropriate assessments of device performance also remain a bottleneck for microfluidic devices. Standards reside at the core of mature supply chains generating economies of scale and forging a consistent pathway to match stakeholder expectations, thus creating a foundation for successful commercialization. This article provides a unique perspective on the need for the development of standards specific to the emerging biomedical field of microfluidics. Our aim is to facilitate innovation by encouraging the microfluidics community to work together to help bridge knowledge gaps and improve efficiency in getting high-quality microfluidic medical devices to market faster. We start by acknowledging the progress that has been made in various areas over the past decade. We then describe the existing gaps in the standardization of flow control, interconnections, component integration, manufacturing, assembly, packaging, reliability, performance of microfluidic elements and safety testing of microfluidic devices throughout the entire product life cycle.

Proceedings of the First Workshop on Standards for Microfluidics.

In the last two decades, the microfluidics/lab-on-a-chip field has evolved from the concept of micro total analysis systems, where systems with integrated pretreatment and analysis of chemicals were envisioned, to what is known today as lab-on-a-chip, which is expected to be modular. This field has shown great potential for the development of technologies that can make, and to some extent are making, a big difference in areas such as in vitro diagnostics, point of care testing, organ on a chip, and many more. Microfluidics plays an essential role in these systems, and determining the standards needed in this area is critical for enabling new markets and products, and to advance research and development. Our goal was to bring together stakeholders from industry, academia, and government to discuss and define the needs within the field for the development of standards. This publication contains a summary of the workshop, abstracts from each presentation, and a summary of the breakout sessions from the National Institute of Standards and Technology Workshop on Standards for Microfluidics, held on June 1-2, 2017. The workshop was attended by 46 persons from 26 organizations and 11 countries. This was a unique and exciting opportunity for stakeholders from all over the world to join in the discussion of future developments towards standardization in the microfluidics arena.

Product qualification: a barrier to point-of-care microfluidic-based diagnostics?

One of the most exciting applications of microfluidics-based diagnostics is its potential use in next generation point-of-care (POC) devices. Many prototypes are already in existence, but, as of yet, few have achieved commercialisation. In this article, we consider the issue surrounding product qualification as a potential barrier to market success. The study discusses, in the context of POC microfluidics-based diagnostics, what the generic issues are and potential solutions. Our findings underline the need for a community-based effort that is necessary to speed up the product qualification process.

Standards for connecting microfluidic devices?

The field of microfluidics is maturing slowly but steadily and new products are entering the market, showing a bewildering number of technologies and formats. This article states the need for standards for microfluidic interconnections, chip dimensions and a vocabulary. It also explains where and why those standards might be useful. A description of the ongoing standardization activities is given and the need for further work is explained.