RADIANT-CERSI Innovator Support programme: Suna Health turns regulatory complexity into a strategic advantage 

Suna Health is pioneering acoustic digestive state tracking through a wearable patch that continuously monitors gastrointestinal activity using AI-powered acoustic sensing. The discreet patch contains an acoustic sensor and a 200-hour battery, with on-device machine learning classifying gut sounds in real-time through a privacy-preserving app. 

Dr Chad Okay, Founder and CEO of Suna Health and a NHS GP Resident, joined the RADIANT-CERSI DigitalHealth.London Innovator Support Programme to address a critical knowledge gap in navigating regulation for an AI-powered wearable device. Chad was looking for structured, practitioner-led guidance to understand device classification. Additionally, they wanted to build a credible regulatory roadmap that could support investor conversations and avoid costly missteps. 

From a roadblock to a clear, structured pathway 

The RADIANT-CERSI DigitalHealth.London Innovator Support programme stood out to Chad for its delivery of operational insights from practitioners working directly with Medicines and Healthcare products Regulatory Agency (MHRA) and other notified bodies. Rather than academic theory, the sessions offered real-world guidance and curated resources that helped Suna Health avoid expensive mistakes, such as prematurely notified body engagement or misaligned consultant contracts. 

“The programme transformed regulation from an impenetrable black box into a structured process,” says Chad. “It gave me clarity on how intended use statements drive classification decisions and introduced open-source QMS tools like St. Thomas’ GitHub and OpenRegs.” 

Regulatory requirements, such as clinical evidence, along with post-market surveillance and management, were no longer regarded as administrative burdens. Instead, Chad recognised them as an essential means of embedding patient safety insights into products.   

Being a fully funded programme removes cost barriers and levels the playing field for bootstrap startups, strengthening UK digital health competitiveness globally. Without programmes like this, digital health innovation becomes a privilege of well-funded teams rather than accessible to any founder with a commitment to learn.

Understand regulation as a strategic asset 

Chad’s initial goal was to determine Suna Health’s regulatory classification, but the programme also helped the company to understand how use statements directly influence classification outcomes.  

Unlocking this knowledge reshaped Suna Health’s strategy, clarifying both wellness device positioning and medical device certification pathways. This clarity also helped the company achieve a sharper value proposition, a specific customer segment and clear evidence requirements. While their competitors concentrate on indirect proxies or clinical-only approaches, Suna Health can develop clinical proof and set a precedent for acoustic digestive state surveillance. 

“I now view regulation as a core startup competency and strategic framework for building investor confidence, accessing markets and creating defensible moats,” explains Chad. “The programme shifted my view from regulation as an obstacle to regulation as a strategic asset,” says Chad. “Understanding medical device classification complexity creates a strategic advantage that competitors can’t easily replicate.” 

Levelling the playing field for start-ups navigating the expensive world of regulation 

Early startups often negotiate expensive consultancy costs to access regulatory advice. For Suna Health, the fully funded programme helped them avoid expense mistakes, like premature notified body engagement, and saved the company an estimated £10,000 in consultancy fees through the curated resources alone.  

“The programme provides strategic frameworks, so you’ll still need consultants for specialised work, but you’ll engage with them far more effectively. For Suna, this delivered immense value, as creating the regulatory classification strategy and clinical evidence roadmap would have cost more than £20,000 from consultants.” 

The programme also prompted better financial planning and developing a phased approach strategy. By gaining insight into the true complexities, cost and resources involved in medical device certification, the team has been empowered to plan more effectively for long-term growth. 

Suna Health has been equipped with the tools to position its product for immediate launch while maintaining flexibility for future clinical pathways. The company is now focusing on their wellness launch, conducting a 20-patient pilot study with athletes and sleep optimisation users, and pursuing scientific validation studies with academic partners.  

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