Weekly Rundown - 05.02.23

On the 3rd of February, the Department of Health and Social Care had landed a Medical Technology Strategy aimed at boosting NHS access to innovative medical technology. What will it mean to UK medtech sector? When unpacking the core pillars of the strategy, it is interesting to see what data is being presented to go alongside the solution, so here’s the backdrop:

-?????????Total current healthcare expenditure in the UK accounted for 12.0% of gross domestic product (GDP) in 2020, compared with 9.9% in 2019.

-?????????NHS alone spends an estimated ￡10 billion per year on medtech.

-?????????Small and medium-sized enterprises (SMEs) make up 85% of the companies in the UK medtech sector.

-?????????SMEs make up around 31% of medtech employment in the UK.

-?????????The UK medtech industry has an annual turnover of ?￡27.6 billion, provides 138,100 UK jobs, exports over ￡5 billion of products annually, and is comprised of 4,190 UK businesses.

UK medtech sector is reassuringly a big deal for the UK’s economy growth, as seen in the speech that Jeremy Hunt gave at Bloomberg last week. You can read my thoughts on what was presented in the ??UK economic growth plan, but as I said - I am a believer and my team and I are playing an active role in supporting medtech businesses in gaining market access.

UK Medical Technology Strategy is focused on general medical devices, AIMDs and IVDs as it sets a clear vision on three central objectives – right product, right price, and right place, centred on delivering the high quality of care for patients. Right Product is seen as Safe for all, Clinically effective, Innovative and Sustainable. I want to zoom into these points as this new strategy is aimed?to ensure products are clinically safe and effective for all by developing best-in-class regulations and upholding safety standards with emphasis on innovative and sustainable product development. There are just under 2 million products registered for use on the UK market. Surgical equipment account for 16% of NHS annual spend, taking a 2nd place after implants and prostheses with a 17% annual spend. Both these categories combined account for whopping 33% of total NHS spend on medtech. Let’s stay with surgical equipment category for a moment, using surgical instruments as an example. Surgical instrument manufactures must provide objective evidence to ensure that their products are safe and clinically effective. In fact, manufacturers wanting to obtain UKCA mark and place their product on the market in Great Britain must comply with the Medical Devices Regulations 2002 (UK MDR) and be registered with the Medicines and Healthcare products Regulatory Agency (MHRA). Devices with a CE mark (under the EU MDD) with a valid EC certificate, under the transitional arrangements, will be continued to be accepted on the GB market until 30th June 2024. This sets a hard to meet deadline as obtaining objective evidence of safety and clinical effectiveness takes time and investment. We see what is currently happening in EU, with more than 90% of currently valid AIMDD/MDD certificates that will expire in 2023-2024. In the MDCG report, 75% of all Notified Bodies have reported that more than half of all applications from manufacturers are incomplete i.e. missing objective safety and clinical evidence. NHS supply chain has 56 suppliers listed on the surgical instruments framework which will expire mid-August this year. If we were to apply the EU stats to this framework, 50 out of 56 of these suppliers have a CE certificate that will soon expire and around 25 of them will see pro-longed recertification time due to the mistakes in their technical file. This will leave NHS with fewer options and worsen supply chain issue which this Medical Technology Strategy is hoping to fix. Indeed, the first our of four priority areas discussed in the document is named as resilience and continuity of supply, to which I would add compliant medical device supply. EU is fixing this issue with MDR deadline extension, which, although welcomed by many, is causing confusion in the market and leaving some manufacturers, that already have an MDR CE certificate disappointed. In the strategy document, Department of Health and Social Care recognises that regulation is a fundamental part of realising their ambitions. They are promising to work closely with regulators to ensure that priorities are supported by the appropriate regulations and guidance.

Sustainability is being mentioned almost everywhere in the document. Without a doubt, sustainability is an important issue, and one which is highly relevant to medtech. NHS England is one of the largest contributors to greenhouse gas emissions in the UK, responsible for around 4% of the nation’s carbon emissions. Over 60% of the total NHS Carbon Footprint sits within the supply chain, with 10% attributed directly to medical equipment. I have shared my thoughts on ‘Net Zero’ National Health Service and what medtech need to deliver – NHS need more reliable, reusable and longer lasting medical devices. My team and I specifically focus on medical device material compatibility issue and the effect it has on product failure. In the strategy document, it was outlined that the high prevalence of single use devices supplied into the UK health and care system created additional pressure when responding to the rapid increases in patient demand created by COVID-19. ?It was recognised that some of this pressure could have been alleviated if products and supply models were designed to facilitate greater decontamination, reuse or remanufacture of devices. It is therefore accepted that devices that are designed to be decontaminated and reused would help to reduce our reliance on both raw material availability and the capacity of production and logistics. We see how the EU Regulation (MDR) heavily focuses on the safety and performance of a medical device for the lifetime of the product to minimise risk of failure as far as possible.

Cleaning, disinfecting and sterilising medical devices is an important component within healthcare settings to prevent infections. Even before Covid, the UK was seeing over 650,000 yearly cases of hospital-acquired infections, with around 5% of infected patients dying as a result. The survivors require extended hospital care, causing bottlenecks in hospital admissions and waiting lists, putting additional pressure on the healthcare system. Clearing the backlog of elective care by helping to reduce pressure on the NHS is mention in the strategy as it aligns with broader strategic aims. There’s a role that medtech play as there is a call to align and validate medical products instruction for use (IFU) with NHS infection prevention and control practices. We should see less medical devices companies suggesting ‘soap and water’ as their cleaning and disinfection recommendation, when in reality their products are exposed excessive wiping using disinfection wipes or 70% ethanol solution. I often joke that a ￡5 T-Shirt from a local store has more care conditions and recommendation to keep it from shrinking or discolouring than some medical devices worth millions of pounds. That just isn’t right. I highly recommend getting up to date with the Policy paper as it will set the tone for the years to come. This weekly rundown has severely exceeded the word count, so I leave other points mentioned in the strategy for future talks.

In the lab, we have finished our 1st month of 2023 strategy implementation. As I was on the mission to speak with as many medical device regulatory consultants as I can, the team was busy working on increasing our test service offering. You will be relief to hear that our offering is closely aligned with the UK Medical Technology Strategy. We are about to introduce medical device biocompatibility testing along with pre-compliance evaluation assessment service. Biocompatibility testing is growing in demand as many manufacturers are exploring different materials for their medical products with the added net zero focus. We’re also aligned our new IEC60601-1 pre-compliance assessment with the medical device reprocessing validation. Anecdotally, we are yet to hear that product pass they compliance assessment the first time, with many failing basic electrical safety and essential performance with a single cleaning step. Medical devices are cleaned more than once in its lifetime, right? So you should be testing your products after relevant simulated use to avoid disappointment and products failures down the line. More about this in the coming days.