Regulatory breakthroughs for first cohort of RADIANT-CERSI Innovator Support programme

After an exciting few months of collaboration, learning and regulatory light-bulb moments, the RADIANT-CERSI DigitalHealth.London Innovator Support Programme has concluded its first cohort. From simplifying medical device regulation to empowering digital health innovators across the UK, the programme has been an example of how the right support at the right time can transform potential into progress. 

Sam Kyffin, Senior Project Manager at DigitalHealth.London, and Dr Gabriella Spinelli, Director – Innovation & Digital Health at Brunel University of London, reflect on the programme’s impact and share how key learnings will shape the future of regulation.

Building a specialised support network for innovators navigating regulation

Software as Medical Device (SaMD) and AI as Medical Device (AIaMD) for healthcare are developing at such a rate that regulation is struggling to keep up. As this technology reshapes healthcare, from diagnostics to decision support, the rules around how to safely develop, validate and monitor these tools can be difficult to navigate.

For those immersed in the MedTech world, regulation can often be both a helpful safeguard and a complex stumbling block. For startups in particular, the list of hurdles can be daunting, from identifying whether your software can be defined as a medical device to understanding which policies apply. This often leads to companies facing longer development timelines, higher compliance costs and greater uncertainty about approval pathways.

The impact of this isn’t just on the product itself, but on the wider healthcare system. Regulatory hurdles can slow down the implementation of innovation and deter investment, making it harder for digital health companies to bring safe, trustworthy SaMD and AIaMD to market.

Connecting regulatory experts with innovators

The Innovate-UK funded RADIANT-CERSI (Centre of Excellence in Regulatory Science and Innovation in Transformative Digital Health and AI) recognised this frustration, working in partnership with MHRA, NHS and academia. It exists to bridge the gap between cutting-edge healthcare technology and the complex world of regulation, so innovation and safety can go hand-in-hand. 

Supporting innovators in this space isn’t just helpful; it’s essential. It ensures that promising technologies aren’t derailed by uncertainty, and that developers build safety, ethics and transparency into their products from day one. This approach not only empowers innovators but also ensures that innovation thrives responsibly, transparently, and in ways that truly benefit patients and healthcare staff. 

That’s where the RADIANT-CERSI DigitalHealth.London Innovator Support Programme came in. It was born from the idea that brilliant digital health solutions shouldn’t falter because of regulatory confusion. The RADIANT-CERSI DigitalHealth.London Innovator Support programme team recognised a gap in support for early-stage innovators, so they collaborated with the Health Innovation Network South London and DigitalHealth.London to design a safe space to learn, collaborate and share knowledge.  

Across nine webinars, 65 participants were encouraged to share experiences, test ideas and connect with peers facing the same challenges. Funded places meant that even small teams with big ambitions could take part, accessing high-quality regulatory guidance without the expense of consultancy services. Participants gained clarity on foundational topics, and the spirit of collaboration transformed what could have been an uninspiring compliance course into something genuinely energising and supportive.  

The programme brought together a rich mix of perspectives, from university researchers and NHS clinicians to regulatory experts, data scientists and entrepreneurs. 8fold Governance, for example, delivered an insightful overview of the regulatory landscape for SaMD and AIaMD, later returning to explore international frameworks for regulatory compliance. Assuric shared practical guidance on NHS-specific compliance requirements and AI regulatory considerations, while Hardian Health unpacked how to define intended use and determine risk classification.  

Some of the content related to regulatory actions that participants would encounter later in their regulatory journey. To support this, the sessions were accompanied by a dedicated bank of resources, which participants could access beyond the duration of the programme. This is especially important, as continued access to expert insights enables participants to revisit, reference and build upon the material as they progress. 

The session [on quality management systems] opened our eyes to QMS approach for compliance. We know how expensive and timely it is to find a QMS. The advice was HUGE in terms of value, and we have utilised this and started to implement it, which will help us in so many different aspects of our medical device journey.”

– Participant

Today’s session was quite revealing, there is a limit to how much the regulatory consultants can tell us. But actual businesses or organisaitons going through the process shows us how it’s done from a first-person perspective.

– Participant

Outcomes of the RADIANT-CERSI DigitalHealth.London Innovator Support programme

So, what did participants take away? Beyond a boost in regulatory knowledge, many also defined clear pathways to progress their regulatory activities. Companies gained the confidence to navigate the regulatory landscape, plan evidence generation earlier in development and engage with regulators in a more informed way. Perhaps most importantly, companies that participated left feeling connected with peers, as well as a part of the RADIANT-CERSI DigitalHealth.London Innovator Support Programme Network.  

NPS category: Great

100% of participants surveyed said the programme was appropriate for their stage of the regulatory journey.

86% of participants surveyed have or will change their approach to regulatory compliance as a result of being on this programme

Programmes like this don’t just change the trajectory of individual companies; they influence the wider landscape too. RADIANT-CERSI DigitalHealth.London Innovator Support programme’s contributions to MHRA’s software and AI governance ensure that feedback from the programme, such as questions on classifying adaptive AI tools and how to manage software updates without triggering re-approval, will actively inform future policy development. The team will also be sharing insights and impact at events, such as BMJ Future Health, while finding new ways to bring the resources and tools developed through the programme to as many innovators as possible.  

As the first cohort concludes, we take this opportunity to say a huge congratulations to all the innovators who took part, as well as a big thank you to the partners, experts and mentors who made it possible. The RADIANT-CERSI DigitalHealth.London Innovator Support Programme has proven that when we bring innovators and regulatory experts to the same table, great things happen. Here’s to more clarity, more collaboration and a future where innovation and regulation move forward, together. 

The RADIANT-CERSI Innovator Support Programme is funded by Innovate UK in partnership with the Medical Research Council, the Medicines and Healthcare Products Regulatory Agency (MHRA) and the Office for Life Sciences (OLS). It is delivered by the Health Innovation Network (HIN) South London in partnership with RADIANT-CERSI and experts in regulation.

For more information, please visit https://digitalhealth.london/programmes/radiant-cersi