Lucie Wellington, Innovation Manager, shares how a new partnership with regulatory technology company fsub is helping health tech innovators across North West London navigate one of the hardest parts of their journey.
At Imperial College Health Partners (ICHP), we support innovators at every stage of their journey, from idea to implementation and scale. Across that journey, one challenge comes up more often than almost any other: understanding and meeting regulatory requirements. That is the challenge our new partnership with fsub is designed to address.
Why regulation is a barrier for innovators
Medical device regulation is one of the hardest things an early-stage health tech company has to get right, and one of the easiest to get wrong. A recent UK survey of software and AI developers, published as a preprint, captured the problem in one participant’s own words: the process feels like “walking through a foggy, unmarked minefield”. Only around a third of developers in that survey felt confident in their knowledge of the regulation that applied to their products, and many said affordable, reliable advice was difficult to access.
For many innovators, specialist regulatory advice is needed long before they have secured investment, built a team or generated revenue. Yet this is exactly when expert support is most expensive and hardest to reach. The result is an uneven playing field, where access to regulatory expertise can depend more on available funding than on the strength of the innovation itself. A peer-reviewed study of innovators, consultants and certification bodies found that the burden falls hardest on small and medium-sized enterprises, with participants describing it as holding back, and in some cases killing, innovation.
How the partnership came about
fsub first came to ICHP as an early-stage company seeking support through our innovator offer. As we got to know their work, we recognised the value of their Regulatory Navigator platform, not just for fsub but for the wider community of innovators we support. Working in partnership means we can now offer structured regulatory guidance to far more companies than one-to-one support alone would ever allow. It is also a good example of what a healthy innovation ecosystem looks like: one startup helping other startups succeed.
What the Regulatory Navigator does
The platform focuses on UK regulation through the Medicines and Healthcare products Regulatory Agency (MHRA) and the UK Conformity Assessed (UKCA) route. It helps innovators understand which requirements apply to their product, develop the key documents needed for compliance, and build quality and risk management foundations to recognised standards such as ISO 13485 and ISO 14971, which are used across the UK, EU and US. Crucially, the reasoning behind each recommendation is explained and linked to the relevant regulatory requirement, so innovators build genuine understanding rather than simply accepting an answer.
“We aim to make regulatory support accessible, so that regulation is not a barrier to innovation but something innovators can approach with confidence.”
~ Linh Nguyen, co-founder and CEO, fsub
What we are seeing so far
We began with a small invite-only pilot through our Innovation Exchange programme. Eleven innovators registered, and several have returned repeatedly to work through their regulatory requirements, with four completing seven or more sessions on the platform. We have also interviewed six users, and their insights are directly shaping how the platform develops. It is early days, but the signs are encouraging: innovators are spending real time building regulatory understanding, not just exploring a new tool.
“Before using the Regulatory Navigator, I had very little understanding of which regulatory requirements applied to my product. The platform helped me understand where we stand, which standards we need to work towards, and the likely investment required. That clarity has been invaluable in helping us plan our next steps, build credibility, and prepare for growth.”
~ Varun Srivathsan, Founder, Kaapu AI
What happens next
The partnership is now live across our Innovation Exchange programme, and we are continuing to gather feedback and refine the support available. By combining specialist expertise, digital tools and real-world insight from users, we want to make high-quality regulatory guidance accessible to every innovator who needs it, at the stage when good decisions matter most.
To find out more about our support for innovators, visit our Innovation Exchange page, follow us on LinkedIn or sign up to our newsletter.
