MEDICAL TECHNOLOGY MedTech innovations have the potential to
address healthcare challenges and reduce NHS waiting lists, yet the industry faces significant
procedural and funding hurdles. SMEs specifically face significant barriers in developing and
bringing their technologies to market due to lack of regulatory understanding and costs
part of the MedTech Accelerator: Rapid Regulatory Support (MARRS) Fund, a programme funded by the UK’s Office for Life Sciences to provide grants for regulatory guidance and to enable growth in the UK MedTech industry. The findings and recommendations include the following:
Challenges & opportunities for UK MedTech The report Challenges and opportunities for the UK MedTech SME ecosystem 2025 includes insights from a diverse range of SMEs of different sizes at different stages in their regulatory and commercialisation journeys. MedTech innovations have the potential
to address healthcare challenges and reduce NHS waiting lists, yet the industry faces significant procedural and funding hurdles. SMEs specifically face significant barriers in developing and bringing their technologies to market due to lack of regulatory understanding and costs. Funded by the Office for Life Sciences (OLS), the MARRS fund has supported companies by providing grants of up to £30,000 for regulatory guidance, with 142 SMEs already benefiting in the programme. The report was developed based on a survey completed by all SMEs that received grant funding. The report findings cover a number of
key areas: Regulatory needs and engagement: Ony one in 10 SMEs have all their regulatory expertise in house and conversely nearly two-thirds have no internal expertise at all and therefore rely on external consultants. The main types of regulatory support needed by these SMEs included technical file development, QMS development, as well as support with development of their regulatory strategy. Generally, earlier stage support is needed. UK MedTech innovation ecosystem: The UK ecosystem is strong in supporting early-stage research and development but faces challenges in translating
research into commercial products and later moving to NHS adoption. Adoption was highlighted as a challenge – demand signals and access to clinicians was requested to support SMEs. SMEs called for beter coordination across ecosystem stakeholders, such as Innovate UK, Catapults, the NHS, universities, trade associations and regional actors to create a more cohesive support structure. Sustainability and circularity: While many SMEs recognise the importance of sustainability, only a minority have a formal sustainability strategy in place. SMEs identified the need for greater standardisation, external expert support, and accessible carbon reporting tools to help them meet their sustainability goals. High initial investment costs, lack of demand, and insufficient infrastructure were identified as major barriers to delivering circular MedTech solutions. Digital and Secure Data Envionments (SDEs): SMEs developing digital health products in the UK face complex regulatory requirements, limited funding, and fragmented NHS engagement. Navigating multiple compliance standards and inconsistent NHS IT systems adds cost and complexity. Clearer guidance, streamlined regulation, beter data access, and targeted funding are essential to support innovation and adoption. SMEs see SDEs as crucial infrastructure
for MedTech and AI innovation, but few have accessed them successfully. The current model is seen as valuable in theory but too slow, fragmented, and expensive in practice. Making SDEs more transparent, responsive, and SME-friendly could significantly enhance real-world validation and accelerate product development.
Key recommendations The report provides a number of key recommendations: Continue to provide support to SMEs through MARRS-like programmes: There is a high demand for rapid, high
quantity, lower value grant funding that SMEs can use to support them to solve a wide variety of regulatory problems. The most current MARRS funding call was oversubscribed. SMEs do not have much in the way of in-house regulatory expertise and rely on external consultants, supporting them over a regulatory barrier is being proven to significantly accelerate product development and launch. Provide more funding to the UK MHRA: Support from regulators is key, as they have the expertise SMEs need to accelerate product development. A freemium model could be one way to provide some extra funding (ie where basic services are free and more in-depth support is chargeable). A further approach could be an “arms- length” consultancy alongside a delivery partner such as a Catapult, which could enable more SMEs to gain more guidance and support than is allowed under the MHRA’s current remit. Enable more funding to SMEs through the Seed Enterprise Investment Scheme (SEIS) and the Enterprise Investment Scheme (EIS). Increase the R&D tax relief available for SMEs conducting and scaling up clinical trials in the UK to ~33%. Increase government co-investment for MedTech companies, specifically targeted at existing gaps. Innovation: Facilitate a more joined up innovation support ecosystem leveraging NHS, University, Government and Catapult support. With focus on end-to-end (including translational) support. Build the UK MedTech innovation council: Establish a council with representatives from UK funding bodies, universities, Catapults, the NHS, and trade associations to map out and coordinate innovation support. Link this group to an SME-led working group to continue enabling support for SMEs. Grow translational manufacturing innovation hubs: Expand government- supported innovation hubs with ISO13485/ GMP certified facilities to reduce the need for companies to look abroad to scale. Adoption: Enable the NHS to be more accessible for demand signals and innovation / clinical support. Create a national NHS priority and clinical register: Develop a combined National Priority and Clinical Register to publish NHS unmet needs and procurement intentions. This register will help SMEs focus their efforts. Sustainability: Standardise, reward and innovate in sustainability and circularity within the UK MedTech sector. Invest in a centre for materials sustainability in MedTech: Establish a centre to innovate in packaging materials, device materials, and more carbon-efficient
February 2026
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