Contract manufacturing
Hand. “We can give them the parameters we use, details of the equipment we use, and they can go to a third party that can provide this as a service.”
Vast expertise
Hand and his colleagues have been developing their expertise in injection moulding with the BOY35E
before spending too much money on developing [the device], because they might find they have to go back and redo some testing because it’s not been done in accordance with what’s required in order to get the medical device certification,” he adds. The advice the MDMC provides is not exhaustive, and Hand says companies will still likely have to engage with a consultant, but the few days of focused sessions it does provide “gets them off the starting block”. Beyond the manufacturing side of things, the MDMC also has the equipment required to test products in a variety of ways, simulating the wear and tear they’d go through with age as well as the temperatures they might reach when shipped in different climates. “Standard testing procedures they need if they’re developing something that’s going to be used in a particular environment, say a hospital or for home use,” says Hand. “We can also do more analysis type testing,” he adds, including inspecting welds and profiling the surfaces of a device, as well as a failure analysis to find out where a company went wrong with their prototype. Although the MDMC can’t certify that a product has been tested from a regulatory point of view, having the option to run a product through these sorts of analyses gives companies greater confidence going into certified testing. “We can make sure the company gets to a stage where they’re certain the product will survive the testing and they won’t have to pay for it and then redo it,” says Hand. Once a product reaches the stage where it can be manufactured at scale, beyond the capabilities of the MDMC’s small-batch manufacturing, they can take the knowledge gained and a detailed technical report to start the next step of finding a contract manufacturer that can produce the scale of output they need. “We’re dealing with pretty micro-sized companies that are probably not going to get the technology in-house, at least not for some time,” says
42
Although the expertise at the MDMC is vast, starting it has been a learning experience for Hand and his colleagues as well as the companies they work with, and they’ve found themselves acquiring new capabilities to meet the evolving needs of fledgling medical device companies. “Injection moulding is something that was new to us, but we’ve been developing our expertise in,” says Hand. “We can manufacture a mould initially using 3D printing to test it out, then we can manufacture one out of tool steel using our electrodischarge machine.” This can be a huge advantage for a company looking to manufacture using injection moulding, as the step of making a mould can be very expensive, Hand adds. In this case, along with the technical document explaining the manufacturing process, companies that have a product made using injection moulding get a mould they can take on to a contract manufacturer when they’re looking to scale up production. Hand says there are several ongoing projects at the MDMC and no shortage of companies looking to join the list of successful projects, of which he says there are about 20. Among the success stories are an improved radiofrequency coil for use in MRI research and a diagnostic device for prostate cancer. “Our main challenge at the moment is getting renewed funding to go forwards,” says Hand.
The MDMC was made possible largely by a grant in 2020 from the EU’s European Regional Development Fund (ERDF), with other sources of funding being the Advanced Manufacturing Challenge Fund (managed by Scottish Enterprise), Edinburgh and South East Scotland City Region Deal, and the partner universities. With the UK’s withdrawal from the EU, the ERDF is no longer an option, and to make things worse, a caveat to obtaining that funding in the first place was that the MDMC is not allowed to charge companies for its services for a further three years after the transfer of funding finishes. “We can’t immediately go to a business model of charging companies even now that we’ve built up a reputation, that’s why we need some follow-on funding,” says Hand.
In the future, the MDMC will move towards a model of charging larger medical device companies for their services to both expand its capabilities and offset the cost of helping start-ups, but in the meantime, Hand says it’s hoping Scottish Enterprise will support its work in the interim, with a proposal already under review there. With the amount of cost savings and free expertise on offer, Scotland’s medical device start-ups should be hopeful too. ●
Medical Device Developments /
www.nsmedicaldevices.com
The Medical Device Manufacturing Centre
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