Contributed Commentary By Chris Myatt
July 26, 2018 | Microfluidics promise an entirely new medical world to the consumer, where diagnostic answers are delivered on-the-spot, in real time. Complex issues could be resolved within a single visit—eliminating delays for getting results from a distant laboratory, layers of consultations, and the go-around of today’s medical system. This is a compelling vision, and one can get a taste of it at your local pharmacy chain. Go get a cholesterol test, and your results will be provided before the end of your 15-minute appointment. Imagine if the full range of tests were available. The vision is so attractive, in fact, that the grocery chain Safeway invested $350 million to build in-store clinics for on-site comprehensive diagnostics, and hundreds of millions more were invested in rapid testing by the likes of Walgreens and Blue Cross/Blue Shield. These are consumer driven investments, aiming to respond to what consumers wish for.
The investments toward sample-to-answer automated testing in pursuit of this opportunity have been staggering. But there have been remarkably few big successes. If we look at the top 10 public companies today where microfluidics is key to the function of their technologies and products, they have collectively spent nearly $4 billion to develop their technologies and grow their businesses. For this input of capital, these companies generated just over $400 million in revenue in 2017. And there is an active list of private companies coming behind these leaders. At MBio, when we have successfully licensed our technology to companies that have done extensive due diligence on available technologies, we have been compared with over 100 other companies and their technologies—a sobering thought for bringing a new technology to market!
The challenges of microfluidics in biomedical applications are numerous, particularly for measurement devices where subtle interactions can lead to inaccurate results. The interplay of complex materials, such as plastics, adhesives, and other materials can radically alter assay function. Just recently Becton-Dickinson performed a wide-scale recall of blood tubes due to a plasticizer leachant that affected lead tests. If you include the additional complexities of a system employing pumps and valves, there are myriad permutations of how to configure a device, and plenty of ways that Murphy’s Law can show up. And all this functionality must be achieved with aggressive cost-of-goods targets that are reflective of the cost pressures on diagnostics tests.
With a huge opportunity and a challenging path to success, how can companies navigate the rough waters of technology and product development to achieve success? First, the microfluidic technologies have to be rooted in practical approaches that are manufacturable. Second, it takes a highly inter-disciplinary team to design and produce microfluidic devices: fluidic expertise (flow in microchannels is quite different from traditional flow at high Reynolds numbers), assay scientists, materials experts, key plastics vendors, and an instrument team that can deliver the required functionality. Third, the plan must be fundable to attract the capital it takes to commercialize these technologies—combining the freshness of new technology with grizzled experience in hardware, devices, and diagnostics.
Ever since the introduction of smart phones, we have come to a new expectation for accessing information quickly. The consumer is driving demand for instant answers: why can’t this hold for our health status? The field of microfluidics holds great promise; the challenges aren’t insurmountable. Although there haven’t been major wins yet, the value of delivering on this vision is worth sustained research efforts.
Editor’s Note: Chris Myatt is founder & CEO of MBio Diagnostics, Inc. He and several colleagues will be further exploring microfluidics and lab-on-a-chip devices for point-of-care testing next month during a dinner short course during the Next Generation Dx Summit in Washington, D.C. The short course will provide an overview of microfluidic techniques, including valved and valve-less devices, pumped systems, and capillary flow approaches. Practical examples will keep the discussion grounded in the realization of commercializable devices. Myatt and his colleagues will link the science with the commercial case for these devices, including a full discussion of a recent success story of a centrifugal microfluidic molecular assay system.