We leveraged our ability to design medical devices that look and operate like consumer products. FastDetect’s FD-1 system is a sleek, simple product designed from scratch to provide fast, accurate testing outside the controlled laboratory environment. Using a process called sample pooling, the system can process up to five tests at a time instead of one. Our simple, consumer-inspired workflow and design make the system incredibly easy to use: the operator simply drops each test subject’s nasal swab into a biosafe disposable cartridge, inserts it into the instrument, and presses the START button. The system delivers a fully automated swab-to-diagnosis solution, eliminating skilled laboratory operations such as pipetting, and automates data traceability and record-keeping.

We created an experience that considers the challenges of busy public environments, from extreme weather to large crowds. The SmartTest can be set up in any location with access to power and Wifi. Test subjects receive their results from the Cloud in a secure, encrypted mobile app.

With hundreds of people still dying every day from COVID-19, speed to market was critical. Karten Design changed its process, working closely as an embedded part of the FastDetect team, to bring this innovation to the world without delay. This new system changes the paradigm for COVID testing. The company expects that the material cost of conducting RT-PCR testing with FastDetect will amount to just a few dollars per person—significantly cheaper than current PCR tests. The device is currently in clinical testing for FDA Emergency Authorization.