Printed Physically Unclonable Functions for Enhanced Security of Biomedical Devices

Principal Investigator: 
Vamsi Yadavalli, professor, chemical and life science engineering, Virginia Commonwealth University

Co-Principal Investigators: 
Carl Elks, associate professor, electrical and computer engineering, Virginia Commonwealth University

Peter Beling, professor and associate director Intelligent Systems Lab, Hume Center for National Security and Technology, professor, Grado Department of Industrial and Systems Engineering, Virginia Tech

Erdem Topsakal, professor, electrical and computer engineering, Virginia Commonwealth University; director, CCI Central Virginia 

Printed physically unclonable functions for enhanced security of biomedical devices Project Description: 

Counterfeiting is a major security problem that causes significant financial damage and poses threats to individuals, companies, and governments worldwide. In addition to consumer products, counterfeit medical devices, referring to biodevices that falsely represent their provenance, are increasing in volume and sophistication. Current circumstances have exacerbated vulnerabilities in the medical device supply chain. Counterfeit diagnostics, such as COVID-19 tests and N95 masks, are examples from the pandemic. Tampering with authentic devices opens up risks of compromising stored sensitive health information. Further, counterfeit components are susceptible to malfunction, or can carry out malicious acts. In addition to putting patients at risk, counterfeit medical devices harm manufacturers, and impose a great economic toll on the system. The global economic loss due to counterfeiting has been increasing annually and is estimated at $1.9 trillion by 2022. Recent legislation such as the “Safeguarding Therapeutics Act” was proposed to expand the Food and Drug Administration’s (FDA) mandate. However, this is just a small step that highlights the increasing urgency to ensure implementation and improvement of high security measures, e.g., by securing supply chains, tracking or marking genuine devices, and having systems in place to document suspected counterfeits.

Secure-by-design principles provide a strategy to get ahead of the problem, and help distinguish between counterfeit and genuine devices. An approach to increase the data security is the use of functional materials and physically encrypted hardware. For instance, advanced packaging by the incorporation of digital information can be used to identify, trace and authenticate products. Security labels with physical unclonable functions (PUFs) offer a practical solution, as well as a viable, commercializable path to combat the increasingly serious security challenge. A PUF is an object with a unique, random intrinsic physical feature generated in a nondeterministic process. This feature produces a response to a challenge that can be easily evaluated, but guarantees defense against duplication. PUFs have become common over the past decade to provide secret fingerprints. These fingerprints can be generated from manufacturing variations and are typically in electrical or optical forms. Optical PUFs have received a lot of interest because they can generate fingerprints based on visual inspection and image processing without the need for complex and expensive physical readers. This is particularly beneficial in keeping costs low and providing broader access to end-user customer validation. However, to date there has been limited work at addressing the issue of biomedical device and biosensor security using flexible, biofriendly methods. This proposal seeks to address this problem by developing biodegradable secure PUFs using printed electronics based on biocompatible inks developed by the CCI research team. This will be accomplished via the following specific aims: Aim 1 – Fabrication and demonstration of mechanically flexible PUF labels Aim 2 – Statistical validation and performance characterization of the PUF labels Aim 3 – Digitization and authentication of the PUF labels