IMed Consultancy enabling innovation in the mental healthcare sector with Limbic –
Limbic is a London-based start-up that is using world-leading, clinically validated Artificial Intelligence and beautiful product design to make psychological therapy accessible for everyone, everywhere.
Mental health services are facing challenges as demand for talking therapy rises. A result of this crunch is that patients can experience long wait times, which may lead to poor satisfaction and high drop-out rates. Limbic thus developed Limbic Access, an AI-enabled mental health referral chatbot, to support patients in overcoming the stigma associated with referring into services. In addition, Limbic Access enables a comprehensive mental health assessment, releasing Health Care Practitioner (HCP) time so staff can concentrate on delivering the best care possible. With Limbic Access, patients experience shorter wait times for both assessment and treatment and are more likely to get put on the right treatment course, significantly reducing drop-out rates between referral and assessment and onto treatment.
Limbic reached out to IMed Consultancy in Spring 2022. Limbic Access was getting upgraded with novel AI capabilities that required additional regulatory support. Introducing AI to their innovative mental health referral chatbot, in fact, meant going from a Class I to a Class IIa device, subject to different regulatory requirements, including external UK approved Body audit. In addition to this, it was the first time an AI-enabled mental health referral device was being externally evaluated to obtain UKCA-marking, adding an extra layer of uncertainty.
“IMed Consultancy was really open to working with a start-up looking to responsibly and safely innovate in the mental health space. Ours is the first and only approved medical device using AI to support mental health assessment decision making, and we valued IMed’s expertise to make sure all documentation was in order,” says Ben Carrington, Special Projects Director at Limbic.
In addition, as a start-up, Limbic needed to move incredibly quickly to maintain competitive advantage and obtain compliance smoothly, to differentiate themselves from the countless unregulated AI mental health apps and services available to the public.
“Especially now, with AI gaining awareness, all the unregulated apps available on the app stores and other mental health software lacking fundamental clinical evidence, it is imperative for us to continue to demonstrate that AI can be implemented safely and effectively in a mental health care setting,” continues Ben.
With IMed’s support Limbic became the world’s first UKCA-marked AI-enabled medical device to support referrals and clinical assessment in psychological therapy in only 9 months, gaining an important market advantage on competitors.
“We’re proud to have contributed to Limbic’s UKCA marking. We’re fully aware of the difficulties medical device start-ups have to deal with, especially when it comes to regulatory compliance. This case was particularly interesting as AI is still very much a novelty when it comes to medical devices, and regulations were not written with such devices in mind,” declares Leeanne Baker, Founder of IMed Consultancy.