HomeTechUK agencies want new rules for an integrated, medtech pathway for evaluation...

UK agencies want new rules for an integrated, medtech pathway for evaluation and roll-out of innovative devices in the NHS

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Implementation of the UK government’s MedTech Strategy, launched 15 months ago, has seen another major leap forward with the publication of plans for a coordinated new approach for getting innovative medtech evaluated, rolled out and taken up throughout the NHS.

The project, driven by NHS England, NICE and the Department of Health and Social Care’s MedTech Directorate, seeks to create an environment for innovators to thrive, and harnesses the NHS, they say, as “a powerful driver of innovation”.

The launch of a new consultation, open for comments until 15th August, and launched the day [22nd May 2024] Prime Minister Rishi Sunak announced the dissolution of parliament for the general election, received little fanfare as it was inevitably drowned out by other news. But the initiative is being seen as hugely important in delivering on the cross-party commitment to promote British medtech, both as a vital part of the economy and as a means of rapidly improving patient outcomes and experiences whilst driving cost efficiencies in health and social care.

The UK medtech sector, with an annual turnover of 34 billion GBP, and over 4,400 UK businesses, supports 154,000 UK jobs.

The consultation is the first stage in a project to develop the new rules, which is scheduled to involve public, patient, clinician, industry and NHS system input well into 2025; and is in part set to address the challenge that, the consultation document argues, “The category of medtech is incredibly broad and varied, and there is often limited clinical evidence to assess clinical and cost effectiveness. As the pace of innovation accelerates, there is now an opportunity to provide greater coordination for new and existing products, and clarity on what to expect from a NICE evaluation and the role the NHS plays”.

Respondees to the consultation are being asked to comment on five foundational principles upon which the new approach is set to be modelled:

  • Principle 1 – the pathway should be supported by evidence-based advice and guidance from the National Institute for Health and Care Excellence (NICE), focused on technologies with the greatest impact on patient outcomes and the most compelling cases for clinical and cost-effectiveness
  • Principle 2 – the pathway requires a lifecycle approach to support new, early-stage technologies as well as driving greater value from existing technologies in widespread use
  • Principle 3 – the pathway should lead to automatic identification of funding to support routine commissioning and adoption for clinically and cost-effective and affordable technologies
  • Principle 4 – the pathway should support the transformation of clinical pathways and services
  • Principle 5 – the pathway should drive up the quality and use of evidence, helping tackle ethnic and unfair biases in medtech

Important to remember is that this new set of rules is not being developed in isolation, but alongside the new value based procurement methodology for purchasers which moves away from the undue focus on price per item and takes into account impact on patient outcomes, NHS whole system costs and such factors as environmental impact and supply chain resilience.

There will be challenges for all businesses, but particularly for SMEs in finding the resources to meet the demand for evidence to support claims of innovation and improvement, and it’s vital that the medtech sector engages with this process in effective dialogue as the new rules are developed – since they will define the future of the environment and main UK market in which companies operate.

Comments upon or questions about this article can be addressed to chris.whitehouse@whitehousecomms.com

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