New £7 million fund to help UK HealthTech SMEs with regulation

CPI and the Association of British HealthTech Industries (ABHI) have announced the Health Technology Regulatory and Innovation Programme, funded by Innovate UK.CPI is part of the High-Value Manufacturing Catapult. This joint initiative with ABHI will help small and medium-sized HealthTech companies to navigate the HealthTech regulatory processes.The UK has a vibrant and rapidly-growing HealthTech sector, supplying a variety of products such as:syringeswound dressingssurgical robotsdigitally enhanced technologies.SMEs will benefitThis £7 million funding programme will see many UK small and medium sized enterprises (SME) benefit from funds to help meet their regulatory needs.Health technologies are highly regulated, with manufacturers needing to meet stringent requirements to sell goods into:UKEUUSother marketsThe UK’s regulatory landscape for HealthTech is changing, and manufacturers will need to prepare for a UK sovereign regulatory system. This is because the Medicines and Healthcare Products Regulatory Agency (MHRA)is currently consulting on the future regulation of medical devices and invitro diagnostics in the UK.New regulationsCompanies looking to sell into the EU market now must adhere to the new medical device regulations (MDR), and impending in vitro diagnostic medical device regulations (IVDR). This may lead to some UK companies finding their products no longer meet the regulatory requirements to be sold within the EU.In 2019, according to the Office of Life Sciences, the UK’s HealthTech sector turnover was £25.6 billion.SMEs play a vital role in this industry, representing:81% of the businesses20% of the turnover.If SMEs are not enabled to meet regulatory challenges, there is a risk that innovators will be unable to commercialise their ideas and the UK could lose out on vital investment in the HealthTech sector. As such, patients would not benefit from potentially life changing new technologies and devices.Providing assistanceSMEs seeking to commercialise their products often lack internal expertise and capacity to ensure regulatory compliance. This funding and support programme will help HealthTech SMEs access regulatory assistance and knowledge for medical technology and invitro diagnostics.The programme also offers guidance and education on regulatory systems and an opportunity to engage with industry regulatory experts.CPI has a wealth of experience in helping businesses of all sizes to develop and commercialise innovative HealthTech products that change lives.ABHI brings experience and knowledgeABHI brings HealthTech regulatory expertise as well as international market access knowledge.Both organisations have strong connections with:industrygovernmentthe NHSinvestorsacademiaregulatory bodies.