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24 Feb Designing a COVID-19 Cartridge and Test Platform

Posted at 15:37h in Engineering Challenges, featured, IVD by

Key Tech has a long history of developing complex IVD cartridges and instruments for infectious disease testing.  When COVID-19 appeared, it didn’t take long for Key Tech to become involved with many of the world’s leading companies to help innovate and optimize COVID-19 testing platforms.  We couldn’t be more thrilled with playing a role in the multi-pronged solutions that the world is undertaking right now to help all of us safely move through this pandemic.

Being a part of R&D on COVID-19 cartridge and their associated test platforms for companies such as GenMark, Quidel, and Thermo Fisher has shown us that there are some common themes to all of these projects.  First, time to market is everything.  Although that statement may be cliché and arguably true on any product, COVID-19 is causing deep pain worldwide right now.  It’s not an option to spend the next two years developing a new solution to this pandemic.  The world needs solutions right now.  So when it comes to a new COVID-19 instrument or cartridge, there isn’t time for high risk R&D that will take years to complete.  This isn’t to say that there isn’t room for innovation.  Quite the opposite; innovation is what will make COVID-19 tests more reliable, more accessible, and more readily adopted into our daily lives.  But this innovation needs to be balanced by mitigating high-risk aspects of the development as early in the process as possible. If you’re adding a new feature to a COVID-19 cartridge, ask yourself: can this feature can optimized in a short set of iterations?  If it looks like the type of feature that will take 12 months of an equal number of injection mold iterations, you need to go back to the drawing board.  Balancing innovation with risk is critical to getting COVID-19 products out to the public right now so that we can end this.

Second, usability of COVID-19 products has an even higher bar than your average IVD device.  We have all heard stories that labs are stretched thin, running three shifts a day, processing volumes of nasal swabs on a scale that the world has never seen before.  Many of these labs are struggling to find qualified staff to run all of these tests.  In an ideal world, we could assume that every COVID-19 test device is being run by someone who went through adequate training.  But these are not ideal times we’re living in, and the reality is that the user of your product in a lab may have only gotten bare-bones training.  All of this means that usability of a COVID-19 cartridge needs to be exceptional to compensate.

Finally, so rarely do you help design a product that has the potential to bring such a positive impact on yourself, your family, friends, and the entire community around you.  The drive to find creative solutions to hard problems has never been stronger.  We can all put our entire heart into helping to improve testing and treatments, knowing that the impact is so real.  We see the passion in our teams at Key Tech and on our client teams with whom we are collaborating.   I hear the sincerity in their voices as they announce excitement at finding a new design that solves the urgent problems of today.  We couldn’t be more proud of Key Tech and the larger medical device community for how quickly innovation is being brought to ending the pandemic as soon as possible.

Brian Murphy
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