Cambridge Launches High-Value Med Device Institute

The Institute for Biomedical Innovation (IBI) will bring together engineers, clinicians and manufacturers in a facility designed to help researchers develop and manufacture medical technologies to the point where they are ready for clinical trials and, ultimately, real-world use.

Part of Cambridge's Department of Engineering, the new institute has been created by transforming the University's NanoScience Centre on the Cambridge West site into a specialised facility for moving medical technologies from proof-of-concept towards clinically usable products.

The team behind the Institute say the facility is not only unique in the UK, but will support high-value manufacturing and economic growth.

"There's a real gap in the UK between a clever prototype that works in a lab and something that's suitable for clinical trials," said Professor George Malliaras from Cambridge's Department of Engineering, who will serve as Director of the new institute.

"Cambridge has almost everything you need for translation - the science, the clinicians, the entrepreneurs, the supporting organisations - but the pieces weren't connected, and one critical element was missing: the ability to prototype medical devices properly, with patients and regulation in mind."

That conclusion emerged from a series of studies conducted by the Department of Engineering last year, which tracked how early-stage medical technologies are developed into real-world clinical devices.

The findings showed that while early-stage research at Cambridge is exceptionally strong, researchers and spin-out companies often have to look overseas to develop devices suitable for clinical testing.

The IBI aims to change that by offering facilities that will enable medical devices to be developed in ISO-certified environments: a requirement for technologies destined for use in patients.

Unlike typical university workshops, the institute will support what is called 'batch prototyping': producing tens or hundreds of devices, rather than just one or two, to standards suitable for pre-clinical and clinical evaluation.

"It's not just about making something that works once," said IBI co-Director Professor Ronan Daly, from Cambridge's Institute for Manufacturing. "It's about learning how to make it reliably, safely and at a quality level that is traceable and regulators will accept. That's where so many good ideas fail - not because the science is wrong, but because there is no opportunity to test out the manufacturing challenges early enough."

The IBI will support a range of technologies, including implantable devices such as neural interfaces, in-vitro diagnostics, surgical tools and wearable sensors. It will also include specialised facilities to help researchers test how medical devices interact with living cells, and a human performance lab to test wearables with healthy volunteers.

Another feature of the new institute is its focus on sustainable medical devices - an issue of growing importance to the NHS and UK Government. The NHS is committed to achieving net zero by 2040 and in its broader supply chain, including medical devices, by 2045. However, they have already introduced net zero measures into their procurement processes. The Government has said it has a vision of reaching net zero while generating cost savings and improving resilience in part by transitioning away from all avoidable single-use MedTech products by 2045.

"There's huge pressure on the NHS to decarbonise, but very few people know how to design medical devices with sustainability built in from the start," said Daly. "By addressing that at the prototyping stage, we can help create devices that meet future NHS requirements - rather than trying to retrofit sustainability years later."

The institute will explore ways to design devices that can be safely disassembled, sterilised and reused, reducing waste and long-term costs.

Although based in Cambridge, the Institute for Biomedical Innovation will operate as an open-access facility, available not only to University researchers but also to start-ups, SMEs and industry partners.

For early-stage companies, access to specialist equipment and regulatory expertise can be prohibitively expensive. Malliaras and Daly say they hope the IBI will help de-risk innovation by allowing companies to test and refine devices without having to build their own facilities.

"There really aren't many places in the UK where academics or small companies can do this kind of work," said Malliaras. "If you're a start-up developing a medical device, your options are extremely limited."

In the longer term, Malliaras and Daly say they want the IBI to become a national, and eventually international, centre for medical device development, helping to strengthen the UK's manufacturing base.

"We're very good at inventing things in this country," said Daly. "But we often lose value by manufacturing them elsewhere. High-skilled medical manufacturing is something the UK should be doing more of."

"I'm excited that the Department of Engineering is leading the way in this field, in a way which will demonstrably benefit society," said Professor Colm Durkan, Head of the Department of Engineering. "We have a unique opportunity here to rewrite the rule book on how universities interface with healthcare professionals and industry."

The University has committed staff, space and existing equipment to get the IBI started, and the facility is already hosting early users. However, further investment is needed to realise its full potential. The IBI is seeking support from industry, government and philanthropists to expand the institute's equipment and capabilities over the coming years.

An official launch event and national workshop are planned for later this year, bringing together researchers, clinicians, policymakers and industry figures to shape the institute's future direction.

"If we can shorten the journey from lab to clinic - even by a few years - that can have an enormous impact, and make a real difference to people's lives," said Malliaras.