InnovateUK funded Medical Regulatory Navigation Research

InnovateUK funded Medical Regulatory Navigation Research

November 28, 2021 Compliance, Funded Projects, Navigation, Standard CC Admin

Directors at Chilton Computing is celebrating a breakthrough in the company’s history in bringing Artificial Intelligence (AI) technology into the domain of medical regulatory navigation. The rise of digital health technology and the complexity of modern medical applications have led to an increased difficulty for medical regulatory bodies globally. It is funded via the InnovateUK’s digital regulatory navigation platform competition which recognises the urgent need for the UK to develop its own capability to support health product innovators in developing commercial oriented medical devices.

Products designed for use in the health sector cover a very wide range of form and function. There are approximately 600,000 medical devices on the UK market. They are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA). In the EU, there are approximately 500,000 types of medical devices and In Vitro Diagnosis (IVD devices) . In the USA, which is biggest medical device market in the world representing approximately 43.5% of the worldwide market, there are approximately 240,000 medical devices being regulated by the Food and Drug Administration (FDA) department. Whilst there are clearly differences in terms of what and how a product is classified as a medical device, navigating medical device regulations is clearly an area presenting great challenges for technology developers who are increasingly coming from non-medical domains.

The project enables Chilton to work with the leading medical regulatory experts in the UK to develop a AI-powered language analysis platform to guide a user through the maze of regulations for health related products and on the basis answers to questions about

* What the product is designed to achieve
* How the product achieves its goal
* The claims the developer wishes to make for the product
We will use a combination of publicly available data regarding medical device, medicinal compound and disease classification, and structured understanding of medical device regulations and guidance documents to identify the most appropriate classification for the product i.e. is it a medical device (Medical Device, IVD or active implantable medical device) or some other form of regulated product?

The platform also identifies any other regulations which the product must comply with. Once the platform has determined the type of product it will then determine the options and pathways available for obtaining a relevant conformity marking for a product in a given market, including EU CE mark or FDA approval required to sell the product.