Contract manufacturing
Hand’s personal expertise is in the manufacturing space, looking at the use of high-powered lasers to weld together parts with different physical properties, like optical glass and metals, often at a microscale. His Heriot-Watt colleague and a co-investigator in the MDMC, Professor Robert Thomson, is developing deep UV light technologies in collaboration with the universities of Edinburgh and Bath for a project named U-care. The project brings together engineers, physical scientists, clinicians and biomedical scientists, to investigate the potential of deep UV light to kill infection and to remove tissues with extreme precision. Look at U-care and the other medical technology research projects of Heriot-Watt staff – a laser scalpel for minimally-invasive cancer surgery and a microfluidic chip that could improve biomarker detection in liquid biopsies – and it’s not hard to see the value of an in-house manufacturing centre. But beyond that, the MDMC exists to help companies reach the point that they have a working product that can be commercialised, and having such varied expertise can be a boon here too. This is especially true considering the pool of knowledge doesn’t end with Heriot-Watt; the MDMC also includes partners Robert Gordon University and the universities of Edinburgh and Glasgow. “We’re a group of academics with different expertise, but all of us have this interest in medical devices in one way or another,” says Hand.
A helping hand
The Medical Device Manufacturing Centre addresses prototyping and manufacturing challenges.
Getting a leg up
Of course, these numbers are specific to the US regulator, but with a much more stringent regulatory framework in Europe now, courtesy of MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Medical Devices Regulation), it’s unlikely that the expenditure required to reach an approval is much less. In fact, in December 2022, Reuters reported that medical device companies were dropping Europe as a market for certain products due to the high cost. At Scotland’s Heriot-Watt University, Duncan Hand, professor of applied photonics, leads the Medical Device Manufacturing Centre (MDMC). It’s here that he and his colleagues assist Scottish start-ups and SMEs in accelerating their journeys from start-up to scale-up, and hopefully reducing their odds of failure along the way. “In all areas, companies struggle to go from some initial design concept and early prototype through to manufacturing something,” he says. “But in the medical device area, it’s even more difficult because you’ve got the additional regulatory hurdles. We saw that as an area we wanted to focus on, and it fit with a lot of our research activity.”
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In terms of what the MDMC provides to Scotland’s medical device SMEs, it can vary greatly between use cases, with some having a good idea of how to manufacture their product, but needing access to the advanced suite of machinery the MDMC has to offer. Others, Hand says, need help going from product concept through to initial small-batch manufacturing and testing. “It may be that a company has a prototype which they’ve 3D printed, but they need something made in the way in which it will ultimately be manufactured,” he adds. There’s value to be unlocked earlier along this journey too, as the ability to prototype and reach proof of concept can make all the difference when courting investors. To emphasise the value in this further, the MDMC’s services come at zero cost to the companies they work with, so they don’t have to weigh the cost of reaching proof of concept against the potential investment, nor do they have to worry about the financial risk of their design concept failing at the prototype stage. Instead, they have the advice of MDMC at hand and can take another run at it. That advice can come in handy for navigating the regulatory environment too, says Hand. “It can be very important to understand some of the basic issues
Medical Device Developments /
www.nsmedicaldevices.com
The Medical Device Manufacturing Centre
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