The University of Cambridge is establishing a new institution focused on tackling one of the most challenging issues in U.K. medical research—turning promising laboratory discoveries into regulated devices that can be tested with patients.

The Institute for Biomedical Innovation (IBI) will unite engineers, clinicians, and manufacturers in a facility designed to help researchers develop and manufacture medical technologies so they can be 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 specialized facility for moving medical technologies from proof-of-concept towards clinically usable products.

The team behind the Institute said the facility is not unique in the United Kingdom, but will support high-value manufacturing and economic growth.

“There’s a real gap in the U.K. 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 lead the institute. “Cambridge has almost everything you need for translation—the science, the clinicians, the entrepreneurs, the supporting organizations—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 the ways in which 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 resolve such a shortcoming by offering facilities that 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,” stated 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 specialized facilities to help researchers test the ways 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 the U.K. 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 procurement processes. The government has said it wants to reach 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 decarbonize, but very few people know how to design medical devices with sustainability built in from the start,” Daly noted. “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, sterilized, 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 startups, SMEs, and industry partners. For early-stage companies, access to specialist equipment and regulatory expertise can be prohibitively expensive. Malliaras and Daly 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 U.K. where academics or small companies can do this kind of work,” Malliaras stated. “If you’re a startup developing a medical device, your options are extremely limited.”

In the longer term, Malliaras and Daly said they want the IBI to become a national, and eventually international, center for medical device development, helping to strengthen the U.K.’s manufacturing base. “We’re very good at inventing things in this country,” Daly commented. “But we often lose value by manufacturing them elsewhere. High-skilled medical manufacturing is something the U.K. 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,” added 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 realize its full potential. The IBI is seeking support from industry, government, and philanthropists to expand the institute’s equipment and capabilities in the next few 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,” Malliaras concluded.