RADIANT-CERSI Innovator Support programme: Omnilabs Research accelerates regulatory roadmap through expert-led support

Omnihuman VR is a personalised telerehabilitation tool that uses music stimulation to improve compliance with upper-limb rehabilitation exercises for stroke survivors. The product supports clinicians by tracking patient progress through a dashboard, collecting data across hospital and home settings.

Lucie Legrandois, Co-founder at Omnilabs Research, joined the RADIANT-CERSI DigitalHealth.London Innovator Support Programme to deepen her understanding of Software as a Medical Device (SaMD) regulation and anticipate future frameworks. Her goal was to build a robust regulatory roadmap early in the product lifecycle, ensuring safety, reliability and readiness for international expansion. Lucie was also keen to explore AI integration in digital medical devices and understand which regulatory guidance to monitor, alongside gaining clarity on data protection laws.

Developing foundational regulatory knowledge with accessible, expert-led sessions

The programme’s accessible, expert-led sessions were a key draw for Lucie. As an early-stage startup, Omnilabs Research faced the common challenge of fragmented guidance and limited resources to engage regulatory experts. The RADIANT-CERSI DigitalHealth.London Innovator Support programme bridged this gap, offering practical insights and tools to kick-start their regulatory journey.

Blüm, Acorn Compliance, Assuric Compliance, Hardian Health and 8fold Governance were amongst the facilitators that provided deep dives on foundational topics, from identifying intended purpose to navigating clinical evaluation. A session delivered by Anil Mistry, Senior Clinical Scientist in AI at Guys and St Thomas’ NHS Foundation Trust, was particularly useful for the early-stage company, as it offered clear, actionable insights on Quality Management Systems (QMS).

I would recommend the RADIANT-CERSI DigitalHealth.London Innovator Support programme to innovators who are working with digital products, such as Medical Devices, and are unsure of the steps to go through the regulatory compliance process.

Transforming regulatory insights into a long-term roadmap  

The programme served as a catalyst for initiating their regulatory journey. As a result, Omnilabs Research successfully developed a long-term roadmap and began designing their QMS and clinical trials in line with best practices and standards. 

“This programme was perfect to push us to kick off our regulatory journey. We developed a long-term roadmap, started our QMS and clinical trial design according to best standards and regulations,” says Lucie. 

The programme helped increase Lucie’s confidence and comprehension of regulatory pathways by filling in knowledge gaps and providing the necessary guidance to execute regulatory steps accurately. It also offered access to a network of experts and peers, as well as the wider RADIANT-CERSI DigitalHealth.London Innovator Support Programme. These ongoing connections stand as a testament to the programme’s collaborative design, which aimed to foster a community of innovators and industry experts. Connections built through the programme will help to empower teams like Omnilabs Research to navigate complex challenges, such as AI integration and certification planning, with confidence and shared insight. 

Recognising regulation as a necessity 

Lucie’s perspective on regulation evolved significantly through the programme. While she acknowledges the administrative burden, she now sees documentation as essential for patient safety and product reliability.  

“By breaking down in smaller pieces all the elements to consider for regulation and certification, the programme made this work more concrete and achievable: it gave us a thread to follow and progress steps-by-steps towards our final goal.” 

Given the high costs and complexity of certification, the programme has helped Omnilabs Research to access the right tools and expert guidance from the outset, helping them to avoid common pitfalls and accelerate their regulatory roadmap. Next steps include designing and running a clinical evaluation, finalising their QMS for product development and applying for CE marking.  

The RADIANT-CERSI DigitalHealth.London 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