One year after publication of the UK’s inaugural MedTech strategy in February 2023, the UK Department for Health and Social Care (DHSC) has published a reflection paper: The Medical Technology Strategy: One Year On (see our analysis of the original strategy).
The government’s analysis focusses on progress made over the past year and looks ahead to ongoing and future initiatives, including milestones. We have set out a few highlights from this below.
Some highlights from the analysis
The overall central objectives of the 2023 UK MedTech strategy of ‘right product, right price, right place’, and the four key priorities remain unchanged (resilience and continuity of supply; supporting innovation and dynamic markets; enabling infrastructure; and a specific focus on key issues and markets, eg diagnostics).
The government confirms that it views the ‘innovation pathway’ for MedTech (ie the steps from market entry through to adoption eg by the NHS and beyond) as the 'backbone' to the overall implementation plan for the strategy. The achievements and future plans detailed in the government’s analysis are primarily grouped around this innovation pathway theme.
Market entry
The report highlights the following achievements and plans:
- The launch in September 2023 of the Innovative Devices Access Pathway (IDAP) pilot, designed to provide ‘enhanced support to bring novel technologies to market’, with eight focus technologies announced in February 2024.
- The introduction of the MedTech innovation classification framework in April 2024, designed to establish a ‘common language’ and ‘clear criteria’ for a device to be described as ‘innovative’, following consultation with industry. This initiative is at a relatively early stage and remains under review, but it is anticipated that it may assist in the future with how technologies are assessed across the innovation pathway (eg suitability for funding, assessment for cost effectiveness, etc).
- Looking ahead, the government plans to flesh out its ‘Design for Life’ programme in 2024. This is intended to support a move to a circular economy as the default approach across MedTech systems with the objectives of ‘reuse, remanufacture and materials recovery’. Deliverables anticipated include a planned Roadmap for industry in 2024.
Approvals (including regulation)
- This category includes regulation as the 'central enabler' to deliver the UK’s MedTech strategy, and the report references the ‘ambitious reform’ planned for the UK’s medical device regulatory framework and led by the UK MHRA (see our further analysis).
- The government introduces an ‘international recognition framework for medical devices’ as one of the core proposed changes to the regulatory landscape. The proposed framework will enable certain internationally approved medical devices to more easily access the UK market.
- Reference is also made to the recent ‘Equity in Medical Devices’ independent review and to the UK government’s response, with the DHSC welcoming the recommendations made (see our further analysis).
Other aspects of the innovation pathway discussed in the review include progress and challenges related to: (i) NICE assessments (with Late Stage Assessments being introduced progressively); (ii) NHS procurement matters (including plans to develop value-based procurement methodology); and (iii) challenges in adopting new technologies within primary and secondary care settings in the NHS.
Comment
- The UK Health Tech Alliance welcomed the report, the commitments and the progress made, including the innovation classification framework and the IDAP pilot, but at the same time made clear that further progress is needed.
- The planned major reform of the UK medical devices regulatory framework is clearly central to this strategy but we cannot properly assess the impact on the MedTech industry until further information is provided concerning the proposed changes. The timings set out in the analysis are consistent with the recent government Roadmap (with core regulatory changes expected to be laid before Parliament at some point in 2025, see our further analysis).
- The discussion around the planned Design for Life programme – aimed at introducing circular economy plans to the MedTech lifecycle – may be of particular interest to industry stakeholders from an ESG / sustainability perspective. However, little detail has been provided so far and it remains to be seen if / how such aspects may be incorporated into any legislation or binding guidance in the awaited draft revised regulations.
- With respect to the proposed international recognition framework for medical devices, the UK MHRA has since formally confirmed this and published a statement of policy intent at the end of May 2024.
