Filtration and fluid control
“Those are the two important factors that really still drive all of this,” says Gadegaard. “The chips themselves have long been touted for point of care diagnostics and point of care treatment.” Microfluidic devices have a further advantage, in that they can test for several biomarkers simultaneously, enabling you to build up a complete picture of a disease. In this regard, microfluidics could have a key role to play within personalised medicine, for instance by stratifying cancer patients into treatment groups based on biomarker profiles.
Barriers to commercialisation This said, there remains something of a gap between the promise and the reality. For many start-ups in the field, it can be tricky to scale up production and translate a great research idea into a commercial product. As Gadegaard points out, this has to do in part with the costs of injection moulding. “Microfluidic devices really need to be injection moulded for volume production, and the key component is not so much the machine as the tooling that is required,” he says. “Each product requires its own tooling, and I think that’s the limiting factor – every time you need to make a change to one of your devices, you need a new tool. These can cost tens to hundreds of thousands per design and device.”
Henne van Heeren, owner of enablingMNT and secretary of the Microfluidics Association, works with microfluidic start-ups to help them bring their products to market. According to his statistics, the average time needed for success at a microfluidic company is about 11 years, and $50-200m in funding is required for a new diagnostic device. It’s a protracted process with no guarantees and a lack of dedicated testing protocols. “Two problems people have nowadays are finding the right components, and the qualification of their products by an authorised body like the FDA,” he says. “The protocols are not there. If you buy a car, you know it fulfils safety regulations, and that when you go to a petrol station, you’ll get the right petrol for your car
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– there’s an infrastructure behind it. All those things have yet to be developed for microfluidics.” He remarks that, for the market to realise its potential, it needs to get easier for businesses to buy microfluidic parts off the shelf, integrate and test them. A good industry to emulate here would be consumer electronics, in which the vast majority of components used are standardised, and development is much faster.
“Saying that, I think the number of new products you can put on the market in a certain time frame in consumer electronics is much higher than in medical diagnostics,” says van Heeren. “Medical diagnostics is more conservative in that respect – it
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