What is a Biology-gated Transistor? Is it enough to build a graphene biosensor or transistor and put some antibodies down and claim a breakthrough? No.

Demonstrations have been made in academia and by companies claiming a breakthrough, but every device either lacks the ability to use it effectively, misunderstands the complexity of the biology thus misinterpreting the data as truth, or forces the sensing assay into atypical steps and lose relevance.

This approach ends up exaggerating claims of technology readiness reducing credibility in the technology.

SYSTEM ENGINEERING IS EVERYTHING

Let us say I need to write a story. Fortunately, I have this Intel CPU, so I can do that, right? No, I need a computer and a Word Processor. Ideally it does not have some clunky user interface, or a malfunctioning keyboard, and it has auto-save features so I don’t lose everything if it crashes, as well as having the hundreds of other technologies that together make up a computer. Without the CPU I cannot write this, but it alone is not enough to solve my problem. More importantly, if someone came to me and said I could write better if I just bought their CPU which is ten times faster but I had to build my own computer and program my own Word Processor, I would ignore them. My lesser performing CPU is sufficient, available, more robust, likely cheaper, and comes with the rest of the computer and software I need to solve my problem. A chip with graphene Field Effect Transistors is not a biosensor. It adds capabilities no other biosensing technology can do, but alone it is just not enough. A biosensor is an entire system of electrical components making up a reader, mechanical components so it can be worked with, sample handling and processing, layers of software from user interface to back-end to firmware, and layers of analytics that not just determine a response, but remove background noise because life science is always messy and complicated and translate the response into a relevant answer that empowers a user to make an informed decision. Then you have to reproduce it thousands of times with the same result every time, which means a strong manufacturing chain that can produce your products with insightful quality control throughout. Cardea has taken the responsibility for the entire system and has built a Tech+Bio Infrastructure. Our patented design, utilizing liquid gating, is far more technically complex but works with how biology is found in nature, providing relevance. We have a long pipeline of commercial partners looking to develop hundreds of applications powered by Cardean Transistors. None would work with us if we did not carry the responsibility for the entire system and scalable manufacturing chain to deliver on the technology’s promises. Cardea has built that entire chain and continues to improve upon it. The focus on quality defined by the biologist and building the full system allows us to bring actual utility because our approach respects the biology.

QUALITY IS FOR CUSTOMERS

There is an ongoing discussion regarding quality in the graphene community and it was a key concern for us as we engaged with prospective graphene partners. This discussion takes many forms, such as the call for standards, or the utilization of terms such as “pure” or “pristine” or “uniform”. These discussions have not led to any material advancement of the graphene, because unfortunately we as the producers of a product or service do not get to define quality; customers do. ISO:9001:2015, the most recognized, cross-industry standard with regards to quality, defines quality as

“The totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs.”

If a product meets customers’ needs consistently and reliably, then it has quality, but in the absence of a customer application, quality has no real meaning. Cardea has more biologists than material scientists. We define ourselves as a Tech+Bio Infrastructure company and not a graphene company because we serve the biotech community. We run hundreds of bioassays every single week in our internal R&D and launched a product in 2016 to see how customers would experience it. We used both internal and external feedback to improve the chips and even define what “improve” meant. We built new quality control methods that analyze the chips at all angles, reduce waste in production, and correlate defects to sensor outcomes so we know what to get better at. Graphene is the critical development in the field of condensed matter physics. The science is challenging and difficult, and as a result many prospective applications of the material tend to impose the physics view on their customers. This process is disrespectful to the customer and will fail. By taking our customers’ perspective, we respect their view and solve their problems. With Cardean Transistors, only Cardea’s design has a fundamental respect of biology’s complexity built into the design, which has led to its success

CARDEA AND THE “TECH+BIO” VISION (Part I)