Accelerating Innovation and Commercialization Through Standardization of Microfluidic-Based Medical Devices

Published

January 5, 2021

Author(s)

Darwin R. Reyes-Hernandez, Henne van Heeren, Suvajyoti Guha, Luke Herbertson, Alexios P. Tzannis, Jens Ducr?e, Hugo Bissig, Holger Becker

Abstract

The microfluidics industry has grown steadily over the last 5 years worldwide, with the market for microfluidic medical devices experiencing a compound growth rate of 18%. The number of submissions 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 transparent tools for qualifying microfluidics-based devices. The microfluidics community has been slow, or even reluctant, to adopt standards and guidelines, which will create harmonization and assist academia, researchers, designers, and industry across all stages of product development. Qualifying the accuracy and precision of target parameters such as dimensions and device performance remains a bottleneck for microfluidics devices. Standards reside at the core of mature supply chains, forging a consistent pathway to match stakeholder expectations and create 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. We describe existing gaps in the standardization of flow control, interconnections, component integration, manufacture, assembly, packaging, reliability, and safety testing of microfluidic devices throughout the entire product life cycle. Our aim is to help facilitate innovation by encouraging the microfluidics community to work together to help bridge these gaps and improve efficiency in getting high-quality microfluidic medical devices to market faster.

Citation

Lab on A Chip

Volume

21

Issue

1

Pub Type

Journals

Download Paper

https://doi.org/10.1039/D0LC00963F

Local Download

Keywords

microfluidics, lab on a chip, standards, ISO, medical devices

Citation

Reyes-Hernandez, D. , van, H. , Guha, S. , Herbertson, L. , Tzannis, A. , Ducr?e, J. , Bissig, H. and Becker, H. (2021), Accelerating Innovation and Commercialization Through Standardization of Microfluidic-Based Medical Devices, Lab on A Chip, [online], https://doi.org/10.1039/D0LC00963F (Accessed October 8, 2025)