A new £7 million health tech programme, funded by Innovate UK, has been launched to support small and medium-sized enterprises (SMEs) with regulation.
The Health Technology Regulatory and Innovation Programme has been announced as a joint initiative by CPI and the Association of British HealthTech Industries (ABHI), and will help SMEs to navigate both the costs and challenges of regulatory processes within the UK health tech sector.
According to UK Research and Innovation (UKRI), of which Innovate UK is part, ‘health technologies are highly regulated, with manufacturers needing to meet stringent requirements to sell goods’, specifically into markets such as the EU, UK and US.
The body also notes that the UK’s ‘regulatory landscape’ is changing, with manufacturers needing to ‘prepare for a UK sovereign regulatory system’, as the Medicines and Healthcare Products Regulatory Agency (MHRA) is ‘currently consulting on the future regulation of medical devices and invitro diagnostics in the UK’.
There are also further complications of selling into the EU market, which now requires adherence to the ‘new medical device regulations (MDR), and impending in vitro diagnostic medical device regulations (IVDR)’, which could lead to some UK companies ‘finding their products no longer meet the regulatory requirements’.
To avoid a scenario where innovators are ‘unable to commercialise their ideas’, with the UK then potentially missing out on investment and patients on ‘potentially life changing new technologies and devices’, the new programme is seeking to guide SMEs through potential roadblocks.
Support provided by the scheme, through the expertise of CPI and ABHI, will provide – as well as funds – regulatory assistance and knowledge, guidance and education, the opportunity to ‘engage with industry regulatory experts’, international market access knowledge, and the benefit of connections in industry, academia, investors, government, the NHS, and regulatory bodies.
Dr Michael Kipping, Health Innovation Lead at Innovate UK, said of the new funding programme: “We’re delighted to partner with CPI and ABHI on this initiative that is a direct response to two reports commissioned by Innovate UK to evaluate the regulatory readiness of UK HealthTech businesses (IVDR report and MDR report).”
Dr Arun Harish, Strategy Director at CPI, commented: “We know how hard it can be for SMEs to find the financial and knowledge resources to navigate complex and ever-changing health technology regulatory systems.
“We are therefore delighted to be working with ABHI and Innovate UK to offer financial support and a programme of education to small businesses who are ready to commercialise innovative health technologies of the future.”