Guiding Innovative Medical Devices Through the UK’s Regulatory Process and Into the Marketplace

Our Client & Their Goals

Our Client had developed an innovative medical device that could be used to diagnose a specific ailment without requiring the existing invasive and painful diagnostic procedure. They wanted to make this medical device available in the United Kingdom, but they were unfamiliar with the regulations and certification processes for new medical devices in this market. They asked for our guidance on navigating the UK’s medical device certification processes and positioning their device in this marketplace, and our expertise in identifying potential manufacturing and distribution partners.

CamIn’s Solutions

We assembled a project team including 12 world-class experts drawn from science, medicine, and industry. Our team provided expert insights regarding how our Client could prepare for the UK’s regulatory processes, and identified the best approach that they could take to commercialise their new device. We also identified and evaluated potential manufacturing and distribution partners in the United Kingdom who would be well qualified to help our Client introduce their device in this new market.

Our Client was impressed by the speed of our analysis—which we had delivered in just six weeks—and appreciated the quality and detail of the advice that we provided. They are now pursuing clinical trials for their innovative medical device.

The Impact

The advice and insights that we provided helped our Client prioritise their remaining technical development work on their device, and prepared them to succeed in the subsequent certification processes. After guiding them through the regulatory environment, we also identified an effective strategy for positioning their innovative device in the UK’s medical device market.

Our Client was impressed by the speed of our analysis—which we had delivered in just six weeks—and appreciated the quality and detail of the advice that we provided. They are now pursuing clinical trials for their innovative medical device.