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%.

Limitations with cell cultures and experimental animal-based studies have had the scientific and industrial communities searching for new approaches that can provide reliable human models for applications such as drug development, toxicological assessment, and in vitro pre-clinical evaluation. This has resulted in the development of microfluidic-based cultures that may better represent organs and organ systems in vivo than conventional monolayer cell cultures. Although there is considerable interest from industry and regulatory bodies in this technology, several challenges need to be addressed for it to reach its full potential. Among those is a lack of guidelines and standards. Therefore, a multidisciplinary team of stakeholders was formed, with members from the US Food and Drug Administration (FDA), the National Institute of Standards and Technology (NIST), European Union, academia, and industry, to provide a framework for future development of guidelines/standards governing engineering concepts of organ-on-a-chip models. The result of this work is presented here for interested parties, stakeholders, and other standards development organizations (SDOs) to foster further discussion and enhance the impact and benefits of these efforts.

Heart-on-chip systems are one of the tools at the forefront in the race to develop alternative in vitro preclinical testing for disease modeling, drug toxicity and efficacy assessment. Further innovation and standardization will accelerate their use.

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.

Blood is a complex sample comprised mostly of plasma, red blood cells (RBCs), and other cells whose concentrations correlate to physiological or pathological health conditions. There are also many blood-circulating biomarkers, such as circulating tumor cells (CTCs) and various pathogens, that can be used as measurands to diagnose certain diseases. Microfluidic devices are attractive analytical tools for separating blood components in point-of-care (POC) applications. These platforms have the potential advantage of, among other features, being compact and portable. These features can eventually be exploited in clinics and rapid tests performed in households and low-income scenarios. Microfluidic systems have the added benefit of only needing small volumes of blood drawn from patients (from nanoliters to milliliters) while integrating (within the devices) the steps required before detecting analytes. Hence, these systems will reduce the associated costs of purifying blood components of interest (e.g., specific groups of cells or blood biomarkers) for studying and quantifying collected blood fractions. The microfluidic blood separation field has grown since the 2000s, and important advances have been reported in the last few years. Nonetheless, real POC microfluidic blood separation platforms are still elusive. A widespread consensus on what key figures of merit should be reported to assess the quality and yield of these platforms has not been achieved. Knowing what parameters should be reported for microfluidic blood separations will help achieve that consensus and establish a clear road map to promote further commercialization of these devices and attain real POC applications. This review provides an overview of the separation techniques currently used to separate blood components for higher throughput separations (number of cells or particles per minute). We present a summary of the critical parameters that should be considered when designing such devices and the figures of merit that should be explicitly reported when presenting a device’s separation capabilities. Ultimately, reporting the relevant figures of merit will benefit this growing community and help pave the road toward commercialization of these microfluidic systems.