Challenges and opportunities for the UK MedTech SME ecosystem 2025

The MedTech sector has significant potential to help address healthcare challenges and ease NHS pressures, but SMEs often struggle with high costs and limited regulatory expertise. To address these barriers, the Office for Life Sciences (OLS) funded the MedTech Accelerator: Rapid Regulatory Support (MARRS) programme, providing grants of up to £30,000 for regulatory guidance. To date, 142 SMEs have benefitted, spanning a wide variety of medical technologies including combination devices, diagnostics, and Software as a Medical Device (SaMD). This report is based on a survey of all funded SMEs, designed by CPI with input from advisory partners such as BIVDA, ABHI, OLS, DHSC, and industry representatives. The findings reflect the experiences and needs of SMEs at different stages of their regulatory and commercialisation journeys.