The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has selected five technologies for its AI Airlock pilot scheme.
The scheme will explore how AI can be regulated in the medical device field to enable products to be delivered safely and quickly.
The technologies selected are considered to have potential in diagnostics and care, including for cancer and chronic respiratory disease patients, as well as for patients requiring radiology diagnostic services.
AI Airlock is a regulatory sandbox – a study that enables businesses and manufacturers to experiment with products with supervision from a regulator (in this case, the MHRA). The results can be used to support future approval applications.
The project seeks to benefit both manufacturers and the MHRA, offering them each additional insights into the safety, efficacy and regulatory needs of the developing space. The MHRA has said that it will lead to “a more bespoke and enabling regulatory framework”, as well as a simpler route to market and quicker adoption of potentially transformative technologies in the NHS.
Laura Squire, medtech regulatory reform lead and CO at the MHRA, said: “By examining the technologies announced today in a safe setting, in partnership with technology specialists, developers and the NHS, we can test and improve the rules for AI-powered medical devices, helping get products like these to the hospitals and patients who need them sooner.”
The medical AI market size was $81.8bn in 2022, according to GlobalData, which forecasts a compound annual growth rate (CAGR) of more than 31% between then and 2027. Leaders in the market include 3M, GE Healthcare and Medtronic.
At the 2024 MedTech Conference in October, Joselia Carlos, a senior medical device analyst at GlobalData, said of the use of AI in the sector: “The integration of AI in healthcare delivery is not just about automation but it is also about creating a more human-centred approach to medicine. When physicians are liberated from routine tasks, they can spend more meaningful time with patients, which ultimately results in better diagnoses, treatment plans, and patient satisfaction.”
