RADIANT-CERSI Innovator Support programme: MedForce AI unlocking new opportunities for business development through enhanced regulatory knowledge 

MedForceAI creates specialist diagnostic generative artificial intelligence (GenAI) products, which are designed to reduce waiting lists and prevent adverse events. 

Jay Liu, Co-founder and CEO at MedForceAI, enrolled on the RADIANT-CERSI Innovator Support programme with the ambition of strengthening his regulatory knowledge for AI as a medical device (AIaMD), as well as developing a clear regulatory roadmap, including timelines and costs. From here, the company aims to secure Class 2b status and is in the process of building a multi-site NHS Trust pilot to collect the required data. 

Unlocking regulatory confidence through expert-led sessions 

The RADIANT-CERSI Innovator Support programme brought together regulatory organisations to lead accessible presentations for innovators looking to take the next step on their journey. This access to the latest regulatory information directly from experts set the programme apart for Jay, who developed the confidence to navigate the complex web of documents and processes needed before and after certification.  

A webinar led by Dr Paul Jewell, Co-Founder and CEO at Assuric, was especially helpful for MedForceAI’s understanding of AIaMD. The session provided a comprehensive overview of UK-specific frameworks for digital tools, examining key regulatory policies such as Medicines and Healthcare products Regulatory Agency (MHRA) and NICE guidance; Digital Technology Assessment Criteria (DTAC); NHS England DCB standards; and NHS AI governance.  

This was especially relevant and insightful for MedForceAI, which tests and builds clinical GenAI products for pathways across primary and secondary care, as Jay explains: “The programme has provided certainty, which cannot be underestimated when planning timelines, revenues and resources. This is especially relevant when talking to investors.” 

I would recommend the RADIANT-CERSI DigitalHealth.London Innovator Support programme if you want to de-risk your commercial roadmap – you need a lot of regulatory information and support.

Spreading benefits of RADIANT-CERSI Innovator Support programme to the wider industry 

Aside from improving understanding of the regulatory landscape and compliance process for AIaMD, the programme has led MedForceAI to change its business model. The company are exploring how they can spread the knowledge it unlocked through the programme by simplifying the go-to-market process for other GenAI builders. This includes expanding their offer so future partners, such as medical associations, can piggyback on their infrastructure and processes. By acting as a blueprint for others in the sector, MedForceAI is helping to accelerate innovation, as well as make cost, time and resource efficiencies across the sector.  

“Simplifying the GenAI go-to-market process for doctors, for example, is a better use of everyone’s time – and means they can simply focus on building and testing patient impact on specific clinical pathways,” says Jay. 

Now, they are not only helping clinicians on the frontline, but also the innovators behind the scenes who are driving the shift from analogue to digital. 

Positioning regulation as more than just a bureaucratic burden 

The breadth of information covered by the programme reinforced the importance of getting regulation right the first time for Jay. “Ignorance isn’t bliss. I have met so many companies that focus on their AI benefits but not the risks that regulation mitigates against. If you don’t put patient safety at the core of your offering, you’re clearly not going to make it in this industry…  

I wouldn’t go as far as regulation will act as a competitive moat, as some companies think – more like a non-negotiable… The programme made me realise how expensive and time-consuming medical device regulatory compliance is, and how most companies will fall at this step due to a lack of financial and regulatory support to achieve certification…”  

Programmes like RADIANT-CERSI DigitalHealth.London Innovator Support programme aims to make specialised knowledge accessible. On a personal level, Jay has unlocked new knowledge and confidence in relation to regulation. For MedForceAI, this new understanding has developed their business – not only supporting their roadmap to regulatory credibility but also positioning their product as a blueprint to save clinical innovators time, money and resources in their own regulation journey. 

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