How Healthy is it for International Health-Tech Companies to Expand to the UK?

19 Nov

With its £33 billion medical technology (MedTech) industry, the UK is increasingly attractive for international MedTech companies. However, expansion involves navigating regulatory, financial, and strategic considerations unique to this market.

Fast-Track for International Health-Tech Approvals. The Medicines and Healthcare products Regulatory Agency (MHRA) sets rigorous standards for MedTech products, making compliance a crucial first step. Recent reforms under the Health and Care Act 2022 now offer easier pathways for international companies. The MHRA has introduced a faster process for approving overseas medical products called the “International Recognition Procedure.” This procedure allows products that have undergone a thorough assessment by a regulator with comparable standards, such as the FDA in the US, to be subject to minimal checks before being approved for the UK market.

Opportunities with the NHS. The publicly funded National Health Service (NHS) is the largest purchaser of MedTech in the UK, providing approximately 86% of the country’s healthcare services. Entering the UK market through the NHS presents significant opportunities, particularly for digital health solutions such as clinical efficiency tools, innovative apps, wearables, health analytics, remote consultation tools, and monitoring devices, all of which are in high demand. There are various routes to selling to NHS agencies, depending on the product or service. Successful engagements with the NHS require a thorough understanding of public-sector procurement laws under the Public Contracts Regulations 2015, which are often crucial for securing long-term adoption.

Data Privacy and Compliance: Navigating UK Data Protection Laws. The UK’s data protection framework, derived from the European General Data Protection Regulation, imposes stringent requirements for safeguarding patient personal data, which are classified as “special categories of data” requiring enhanced protection. Digital health firms must establish compliant data practices to avoid the significant penalties associated with breaches. Collaborating with legal advisors to ensure alignment with data protection laws and best practices is crucial for fostering trust and ensuring the security of patient information for UK-based patients.

Addressing Workforce Challenges with AI Solutions. The UK’s healthcare sector is grappling with significant workforce shortages, creating opportunities for AI-driven health-tech solutions. Companies offering automated diagnostic tools, for instance, can help alleviate the pressure on clinical staff by streamlining processes and improving efficiency. There are numerous opportunities for MedTech providers, but to successfully enter the market, it is crucial for these companies to comply with the various laws, regulations, and guidelines on AI products, as health regulators meticulously examine these technologies to ensure they meet safety and efficacy standards.

Regional Tech Hubs Outside London. Cities like Manchester and Cambridge offer thriving ecosystems for MedTech companies seeking cost-effective alternatives to London. A med-tech startup, for example, could leverage local research facilities and reduced operational costs, benefiting from government incentives in these hubs. As the first UK city to have devolved control of its £6 billion health and social care budget, Manchester has developed a more streamlined innovation adoption pathway overseen by Health Innovation Manchester. This initiative aims to deliver new health and social care innovations rapidly and at scale, presenting a unique opportunity for life science companies.

Initiatives to Help SMEs. The UK is an attractive market for MedTech companies as it offers substantial support to SMEs, an example being through initiatives such as Innovate UK. Innovate UK has identified that SMEs often struggle with regulatory barriers, which can create significant financial and time burdens when bringing innovative medical devices to market. To address these challenges, the Health Technology Regulatory Innovation Programme provides comprehensive support to help SMEs navigate the complex regulatory landscape. This support, combined with specialised legal assistance to ensure compliance with all relevant laws and regulations, can significantly enhance the chances of success for MedTech companies in the UK. By leveraging these resources, businesses can mitigate risks, streamline their market entry process, and ultimately thrive in the competitive UK MedTech market.

Conclusion

The UK offers a robust and supportive environment for international MedTech companies, particularly SMEs, looking to expand. With comprehensive regulatory support, thriving regional tech hubs, and significant opportunities within the NHS, the UK is well-positioned to help MedTech innovators succeed.

At Asserson, we are here to provide specialised regulatory guidance and support, ensuring your business complies with all relevant laws and regulations. We help you mitigate risks, streamline the market entry process, and ultimately make your business more successful in the UK MedTech market. We are happy to chat and discuss how we can assist you further.

Feel free to reach out to Deborah Tastiel at Deborah.tastiel@asserson.co.uk for more information.