The EU-funded project FABIMED (Fabrication and functionalisation of biomedical devices) has developed innovative mass manufacturing processes for the next generation of medical devices. With the latest moulding technology, devices can be customised in bulk batches, driving down costs. ‘New medical technology will help tackle the challenges of an ageing society with growing comfort standards. Digital, wearable devices enable universal, cost-effective and constant care, and our project could help make them accessible for everyone,’ says Pablo Romero, FABIMED Project Coordinator. The manufacture of medical devices is complicated by the fact that they often have disposable elements, whilst other microcomponents such as pumps and sensors need to be integrated. Previously, the technology used to produce innovative prototypes could not scale-up to mass production. But FABIMED has bridged this gap for three products - a microneedle patch, a microfluidic film and an ultrasound sensor - by developing micro-moulds that can replicate the product at high speed and low cost. ‘The moulds were micromachined and then nanostructured with very specific patterns, allowing the replicated part to incorporate customised behaviours without the need to assemble multiple microparts. This cuts costs and complexity whilst it also simplifies certification processes,’ explains Romero. The project also developed a ‘quality monitor’ used during the manufacturing process. This system can take such fast readings that it can measure with micron accuracy every single part in an injection moulding line. This approach dramatically reduces the time it takes to put a product on the market once a change or improvement to it has been made. One of the products developed under the project was a drug delivery patch which, unlike conventional patches, does not deliver a continuous stream of drugs. It is a digital device which can store a variety of drugs in sealed drug-wells, releasing them at set rates, times and sequences. The patch can be managed via a Bluetooth connection with a mobile phone, and the microneedles in the patch are so small that they don’t produce any pain or bleeding. FABIMED used the multipart adjustable mould to produce a patch with many microneedles with one single injection moulding shot, in just a few seconds. ‘This high-precision product can now be made quickly, at high quality and at low cost,’ says Romero. The project also developed a microfluidic film which can analyse blood, and a miniaturised ultrasonic transducer for intravenous medical imaging. The three FABIMED products are now being planned for wider commercial deployment. ‘With FABIMED we have contributed to lowering the manufacturability barriers for many innovative medical SMEs in Europe. Their products can be much more easily manufactured in Europe, at very competitive costs and with the highest quality,’ concludes Romero. FABIMED project partners are still collaborating to improve parts of the manufacturing process. Meanwhile, Romero is hopeful that the technology developed by the project can be extended to new uses other than medical devices.
FABIMED, micromedical device, mass production, microneedle patch, microfluidic film, ultrasound sensor