Making Sense Of MedTech In The UK

Getting any new technology into the UK National Health Service (NHS) can be a painstaking and Kafka’esq process for even the most enduring of entrepreneur.  The Academic Health Science Network (AHSN) ostensibly exist to make such a process easier and therefore smooth the path of innovations into the NHS.

The challenge was highlighted by a report published last year that emphasized the difficulties in spreading even the most straightforward innovations across the NHS.  The report suggests that traditional approaches, including publicising them at conferences and producing toolkits, are not working, and instead advocates the need for more manpower to help do the vital work of spreading new innovation.

This manpower should consist of teams built around the innovators themselves to help with things like marketing, change management and investment appraisal. Suffice to say, the resourcing for such teams is not present in the NHS today, with just 0.1% of total NHS spending devoted to the adoption of innovation.

“As long as the NHS sets aside less than 0.1 per cent of available resources for the adoption and spread of innovation, a small fraction of the funds available for innovation itself, the NHS’s operating units will struggle to adopt large numbers of innovations and rapidly improve productivity,” the report says.

Navigating the maze

That suggests that there is plenty of innovation coming into the system, but it gets lost along the way.  The AHSN have recently published a new report that aims to demystify the process and therefore make it easier for entrepreneurs and startups to navigate it successfully and get their innovations in the hands of medics and patients.

The report identifies six key activities that form the innovation pathway into the NHS:

  1. Creation – The authors advocate the PICO method of evaluating the viability of your product. What population of patients will it address? How does it solve the problem? How is this problem addressed at the moment? What’s the difference between the new method and current treatments?
  2. Development (prototype) – The next step is to then develop a prototype that can be tested and refined based upon market data.
  3. Development (trials) – This is then followed by a clinical testing process that is well established for pharmaceutical products, but much less so for MedTech. Nonetheless, it’s increasingly common for regulators to require data to underline both the efficacy and safety of any medical product or technology.
  4. Regulation – The next stage is therefore to seek regulatory approval for your product, both for the UK and EU markets, which was historically aligned under the EU Medical Device Directives.
  5. Evaluation/reimbursement – Once the technology has secured regulatory approval, the authors advocate securing evaluation and endorsement by the National Institute of Health and Care Excellence (NICE) to help with reimbursement and selling into the market.
  6. Commissioning and adoption – The final step is to try and get your technology both commissioned and widely adopted. The paper suggests that the NHS has a new procurement model that aims to streamline matters, with procurement broadly aligned with 11 product categories.

“MedTech innovators often refer to a ‘Valley of Death’. This is part of the pathway where products have been developed but take anywhere between 5 and 10 years to navigate regulation, endorsement and procurement hurdles before they have the opportunity to generate significant revenues,” the authors explain.

The difficulties inherent in both getting new technologies into the NHS and then spreading them widely is something that has been acknowledged, and whilst this document does a good job of outlining the steps involved, the entire process can remain long and uncertain, with even successful navigation no guarantee of market adoption.

The report is designed not to be the final answer, but rather the first in an ongoing body of work to better support the introduction of new technologies into the NHS. Time will tell just how effective they prove to be.

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