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New spinout from Engineering Science aids navigation of medical device regulations

Data-driven digital tool RegMetrics supports health technology innovators on their regulatory journey by helping them interpret complex regulations

RegMetrics graphic showing tool's four steps: 1) Device description 2) Medical device 3) Classification 4) Result

RegMetrics, a digital tool to support health technology innovators in navigating medical device regulations, has been created as a spin-out company from the Department of Engineering Science by the Natural Interaction Lab at the University of Oxford.

The tool, previously called Oxford Global Guidance, already has 830 users worldwide in the MedTech industry, including academics, SMEs, incubators, accelerators and investment companies. The spinout aims to use £800K in funding secured from Innovate UK to release new features such as incorporating the next steps on the regulatory journey, which consists of device-specific safety and performance requirements, conformity assessment route, suggested standards and accredited organisation.

Rita Hendricusdottir, RegMetrics CEOThe tool was developed by the Natural Interaction Lab (NIL) at the University of Oxford as a solution for a need that was observed within the community of innovators. RegMetrics CEO Rita Hendricusdottir (pictured left) explains, “By performing a need-led study, we found that there were many academics and start-up companies that needed to better conform to the regulations earlier on in their development. This would allow them to place their innovation onto the market and make patient impact within a short timeframe”.

She adds, “Using a needs-led, bottom-up approach, we developed a free-to-use digital tool in order to support as many innovators as possible at a global scale”.

“This tool is really useful, it would have saved us many months trying to classify our device, if this tool was available 12 months ago”

User testing of RegMetrics has confirmed excellent usability of the tool, with most participants agreeing that they would use it frequently during the development of a medical device.

Group Leader of the Natural Interaction Lab and Associate Professor of Engineering Science Jeroen Bergmann (pictured right) says, “It is great to see that the leading research in regulatory data science at the University of Oxford is being translated by RegMetrics into an impactful platform that can support users on their regulatory journey”.

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