Guiding HealthTech SMEs through new Regulations

A joint initiative to help small and medium sized HealthTech companies navigate regulatory processes in light of new changes that will affect the UK medical sector, has been announced by the Centre for Process Innovation (CPI) and the Association of British HealthTech Industries (ABHI),

The Health Technology Regulatory and Innovation Programme is supported by a £7m funding programme from Innovate UK to help companies prepare to meet a new UK sovereign regulatory system that is being guided by consultation with the Medicines and Healthcare Products Regulatory Agency (MHRA). This will require companies looking to sell into the EU market now adhering to the new medical device regulations (MDR) and impending in vitro diagnostic medical device regulations (IVDR), which could prove difficult to some UK companies.

The Office of Life Sciences reported that in 2019 SMEs played a vital role in this industry, representing 81% of the businesses and 20% of the turnover and any loss of businesses could impact on innovators wanting to commercialise ideas and a loss in vital investment into the UK sector.

The new funding and support programme aims to offer HealthTech SME’s access regulatory assistance and knowledge for medical technology and invitro diagnostics, guidance and education on regulatory systems and an opportunity to engage with industry regulatory experts.

Dr Arun Harish, Strategy Director at CPI, said: “At CPI, we have worked with many small HealthTech businesses and 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.”

Richard Phillips, Director of Strategy at ABHI commented: “A defining feature of the HealthTech sector is its diverse and innovative community of small and medium sized businesses. But often the cost, and sheer complexity of regulatory compliance, is a hinderance to growth. By partnering with CPI and Innovate UK, we are delighted to announce this package of tailored support, so that UK-based HealthTech SMEs can develop safe and effective technologies that save and enhance the lives of patients.”

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