Anti-counterfeit technologies for microfluidic “Lab-on-a-Disc” systems

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Non-genuine medical products, including diagnostic devices, have become a lucrative business for fraudsters, causing significant damage to revenues and reputation of companies, as well as posing a significant risk to the health of people and societies. Along a “digital twin” representing centrifugal microfluidic flow control on exemplary “Lab-on-a-Disc” (LoaD) systems, a novel, two-pronged strategy to safeguard miniaturized point-of-care devices by means of secret features and manufacturing challenges is outlined; such “hardware encryption” is flexibly programmed for each chip during production, and deciphered from a secure, local or online database at the time of use. This way, unlicensed copying can be efficiently deterred by an unfavorable economy-of-scale, even in absence of legal prosecution. • As many medical products, lab-on-a-chip systems represent an attractive target for counterfeiting. For the first time, this paper introduces two independent, but combinable fluidic techniques to unmask illegitimate copies. Without knowledge of hardware encoded secret features for the first, and high manufacturing quality for the second, forgery will lead to failure of the microfluidic device. Based on a digital twin model for liquid handling on exemplary, centrifugal microfluidic “Lab-on-a-Disc” devices, these novel design principles are illustrated. The paper illustrates the intricate coupling between economic and technical factors to underpin how for the unlicensed supplier can be disincentivized by vanishing profit margins.