Chris Whitehouse, a political consultant and expert on medical technology policy and regulation at Whitehouse Communications, an advisor to MedTech suppliers, chair of the Urology Trade Association, and governor of the Anscombe Bioethics Centre, looks ahead at what the coming year holds for the MedTech sector.
The MedTech landscape in the UK and EU is set for significant developments in 2025, with a focus on regulatory changes, sustainability, innovation and the potential roll-out across the NHS in England of a switch to value-based procurement.
UK Developments
- Regulatory Changes: The UK is revising its medical devices legislation, with new regulations expected to be implemented in 2025. Further developments may include a framework to address advancements in medical device software and AI. NICE and the NHS are also developing a new MedTech pathway to streamline the approval and adoption process for innovative technologies.
- AI Integration: The Medicines and Healthcare products Regulatory Agency [MHRA] is developing processes like the "AI Airlock" to streamline the approval of AI-based medical technologies.
- Investment and Innovation: Reports suggest that tax incentives for clinical trials and changes to tax rules and pension regulation could attract more investment and skilled professionals to the UK HealthTech sector.
- Circular Economy: The UK MedTech sector is increasingly adopting circular economy principles, focusing on sustainable product design, reusable devices, and reducing waste - driven by environmental concerns and potential cost savings. 2025 will see rapid progress down the roadmap for change.
- Value-Based Procurement: The NHS in England is set to move towards value-based procurement [VBP], which focuses on the overall value and outcomes of medical technologies rather than just the initial purchase price, aiming to improve patient outcomes and reduce long-term healthcare costs. A new methodology for assessing VBP will be piloted by selected Integrated Care Systems and then rolled out across the NHS in England, becoming formal guidance by the end of 2025 and mandatory for use by end of 2026.
- Late Stage Assessments by NICE: NICE has developed a late-stage assessment approach to evaluate technologies already in widespread use within the NHS. This process aims to ensure these technologies provide value for money and meet clinical effectiveness standards. Some parts of the MedTech sector subject to this process are complaining it is burdensome and unreasonable in its timetable, but NICE is determined to continue.
- Drug Tariff Updates: The Department of Health and Social Care [DHSC] has proposed updates to Part IX of the Drug Tariff, which lists medical devices available for prescribing in primary care and sets the price to the NHS. The aim is to modernise the process and ensure the right products are available at the right price. Some product suppliers fear the changes could lead to restrictions on the freedom of clinicians to prescribe and patients to receive the most appropriate products, adversely impacting on patient experience and outcomes; and impacting on profitability and investment. The review could also lead to a new regulatory home for digital apps.
EU Developments
- Regulatory Overhaul: The EU is holding a consultation on the current regulations governing medical devices and in vitro diagnostic devices. Subject to the outcome of that consultation updates to the regulations will likely follow.
- Sustainability Focus: There is a growing emphasis on sustainability, with initiatives to develop reusable products and reduce waste in the healthcare industry.
- Procurement: the EU is holding a consultation on the reform of procurement regulations across the whole of the EU, affording opportunities for the sector to lobby for a greater emphasis on value-based procurement.
The MedTech sector is dynamic, innovative and evolving, poised for further growth in the coming year, but there’s a real danger that regulatory and other policy changes risk hampering as well as helping the sector’s opportunity to fulfil its true potential. The sector must continue to engage with the EU institutions and the UK’s government and its agencies to maximise opportunities and minimise threats.
The Author used AI in preparing this article. Comments upon or questions about this article can be addressed to chris.whitehouse@whitehousecomms.com.
