EPSRC IAA funding has allowed researchers in the Department of Engineering Science to develop a new tool to help innovators navigate medical device regulation – helping to ensure new medical technologies comply with industry requirements and reach patients as fast as possible.
Complying with medical device regulations is essential to bring new medical technologies into the market. However, early-stage innovators, academics, and spin-out companies often find it difficult to understand what’s needed – which can delay the introduction of technologies and compromise commercial activity.
“Researchers can get confused and frustrated trying to follow the regulations,” explains Dr Rita Hendricusdottir. “And investors may be reluctant to put money into a device which ultimately may not be compliant. The result is that new technologies don’t get to healthcare settings fast enough, and patients miss out on life-saving treatments and diagnostics.”
But now researchers at the Department of Engineering Science have developed a digital tool to support innovators to navigate the regulations. “The idea was inspired by my own experience of translating biomedical research for healthcare applications,” explains Professor Jeroen Bergmann. “I thought others must have the same experience and wondered if we could develop a tool to support the process.”
An initial session testing the idea of an algorithm to help researchers navigate the regulations showed an appetite among innovators for such a tool. Taking the idea from concept to product then involved a two-year process of research, development and testing with industry stakeholders, including the Medicines and Healthcare products Regulatory Agency (MHRA).
The team talked to innovators and academics about the ‘pain points’ involved in navigating the regulations and what they needed from a potential tool, and then developed, tested, and modified a prototype. A series of workshops involving stakeholders from academia, healthcare, and commercial companies provided further feedback, and helped to share knowledge, identify connections and opportunities, and embed the tool in innovation practice.
The software RegMetrics is now available to innovators and is currently being used by leading academic institutions and by over 1700 (academic) researchers and commercial companies. It has been endorsed by major players in the regulatory field, including the Medical Research Council. RegMetrics has received ongoing recognition through winning an MPLS Division Commercial Impact Award from the University of Oxford, and being named a finalist in the SME National Business Awards 2023.
Professor Bergmann says: “We’re delighted by the reaction to RegMetrics. Feedback from innovators indicates that researchers really struggle to understand and navigate the complex regulations surrounding new medical technologies, and that this hampers innovation and development. Our practical approach provides a simple, easy-to-use framework and we’re delighted to see so many organisations and companies picking it up.”
Rita Hendricusdottir, CEO of RegMetrics, says: “I’m passionate about sharing knowledge between disciplines to enable innovation and the IAA scheme provided vital early-stage funding to allow us to bridge the knowledge gap between law and engineering as we started to develop RegMetrics. It’s hard to secure funding for research related to data science and law and, in this instance, the IAA really filled a gap!"
“Now users should be able to progress their technology faster towards real-world applications and attract investment in the confidence that potential devices will be compliant. And, crucially, patients will have earlier access to life-enhancing medical devices and ultimately achieve better outcomes – which is what it’s all about.”
The projects, Cybernetic Engine for CE Marking (CE2) and Medical Device Regulation Impact Workshops, were funded by the EPSRC from April 2018 to March 2020.
Quotes from end users:
“I could do this [regulatory compliance] myself, but after using RegMetrics, I found it saved me so much time that I can’t be without it.”
Academic Research Services, UK
“RegMetrics is helpful when scoping grant submission activities, de-risking the proposal, and ensuring sufficient budgetary requirements. RegMetrics also helped us with our regulatory strategy, and I would recommend using the tool.”
West Midlands Academic Health Science Network, UK
“Great and in-depth tool which is easy to use and gives lots of insight into the classification.”
MedTech innovator, Germany
“I really like your app, I’m sure it will be used in a lot of companies and start-ups soon! Great job.”
MedTech innovator, Germany
Project team:
Jeroen Bergmann is Associate Professor of Engineering Science at the Department of Engineering Science and Director Oxford Healthtech Labs
Dr Rita Hendricusdottir is Chief Executive Officer of RegMetrics
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