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July 31 2021

The Benefits and Opportunities of Entering the UK Healthcare Market with MedTech Post-Brexit

['The Benefits and Opportunities of Entering the UK Healthcare Market with MedTech Post-Brexit']

We recently hosted a webinar in which we were joined by a host of excellent panellists, with expertise in different areas of UK MedTech uptake. The webinar was aimed at US MedTech companies, informing them on the opportunity for US companies in the UK healthcare market, as well as the best practices for gaining UK adoption.

A lot of useful information was shared in the webinar, so we have written down the main points that will help you to expedite your product’s adoption journey.

The opportunities for US MedTech companies in the UK

The NHS' need for new technology – John West, NHS Operational Manager

To set the context, before the Covid-19 pandemic hit, the NHS was already working flat out at 100%, but still not quite achieving what they wanted to achieve. They managed to keep on top of waiting lists, which weren’t growing at an alarming rate, but there was still a need to do things better.

Since Covid-19 and the shutting down of elective treatment, the NHS waiting list has doubled. There are 5.5 million patients awaiting treatment, and over 7 million more patients who haven’t yet come forward for their treatment.
Restrictions, like social distancing, have made the NHS less efficient and there is a need to get back to over 100% capacity. Unfortunately though, the issue is that there isn’t the infrastructure or the finances in place to facilitate that. Therefore, things have got to be done differently and NHS staff are tasked with working better, smarter and more efficiently, but the workforce is tired. Covid-19 has been extremely stressful for the whole workforce, not just physically, but mentally as well. There simply isn’t any possibility of increasing workloads.

That is why there is such a need for innovative new technologies in the NHS, to unload some of the burden. New technologies don’t just need to provide a new treatment, they’re needed to reduce bed days, move treatments out of primary care and cut costs wherever possible.

The Opportunity of NICE approval

As a government body, the NHS has to go through a rigorous approval process to implement spending and always justifying costs. Having recommendation from the National Institute of Health and Care Excellence (NICE) acts like a big tick on the approval process and provides a lot of leverage in getting funding.

NICE recommendation is so important because hospitals have to justify why they are not choosing to use a technology if it is recommended by NICE. A lot of the time, it provides peace of mind and gives payers of care the confidence to invest in your technology.

US MedTech companies entering the UK market - successful case studies

Mike Kujak, Former Chief Marketing Officer & SVP International Commercialization NxThera Inc

Mike was looking to bring a minimally invasive technology to market, that treated Benign Prostatic Hyperplasia (enlarged prostate), the value proposition was based on the fact that patients could be treated and discharged the same day, saving value bed days.

The technology was beneficial for patients, payers and care providers, so we were able to help them to identify key opinion leaders in the NHS trust and help in starting the NICE process. Prior to coming to the UK, the technology was CE marked but had not been used in the UK before, but we were able to help identify which hospitals were most in need of this technology.

NICE recommendation of the technology saw a massive uptake in its use in the UK, but also helped business in Europe and indeed the rest of the world. It helped to validate the product and reassure providers about the reliability of the technology.

Overall, the uptake of the product in the UK helped to drive revenue for the company and raise the valuation of the business. NxThera was sold to Boston Scientific in May 2018.

Mike’s advice for entering the UK market was that it does take and you will need to be patient. It is useful to fully understand the timeline of NICE and be able to communicate it back to your company, in order to set realistic expectations.

Amit Kukreja, Vice President, Corporate Market Access & Reimbursement at Masimo, Former Vice President, Global Marketing, Reimbursement and Patient Access at Second Sight Medical Products

Amit led market access for SecondSight for over 9 years. He discussed how his journey to adoption in the UK stood out particularly.

Primarily the problem with getting providers to take up the problem was trying to figure out exactly what they were looking for, as they often don’t break down into the specifics of what they want to see from you. For example, there is no clear guidance on figuring out what is needed in clinical trials which can leave a lot of unanswered questions.

Device Access is a META tool™ facilitator, which is a pre-health technology assessment analysis to check through your evidence and finds any gaps. This reduces the risk of going through the NICE process too early, without enough evidence.

The company started the NICE process in 2009 and Amit described the UK as ‘a doorway to prepare yourself to enter other markets’, because NICE recommendation is so widely acknowledged and META tool™ gives you an insight into how to improve your evidence offering. SecondSight was the highest paid out treatment in the US after UK adoption.

How the regulatory industry has changed post-Brexit - Dawn Smiles, Founder and Clinical Director at MedTec Consulting Ltd

As a result of Brexit, there are going to be some changes to regulations in the UK as European Union law no longer applies. Dawn is the founder of MedTec Consulting, who has spent over 22 years working in healthcare, she specialises in the UK regulatory landscape and was able to discuss what changes we will be seeing.

Despite the changes, the UK is still the easiest market to gain regulatory approval because legislation more closely follows the old EU directives.

Until the 1st of July 2023, the UK will continue to recognise the CE mark without any restrictions, but after that, all manufacturers – no matter where they are in the world- must have the new UKCA mark which was introduced in January 2021. This is different for Northern Ireland as they remain a member of the EU.

The UK will not be adopting the MDR or IVDR, but will be continuing with the Medical Device Directive (MDD), Invitro-Diagnostic Directive (IVDD) and Active Implantable Medical Device Directive (AIMDD).

The Medicines and Medical Devices Act was introduced in February of this year. It allows the UK to set its own level of legislation regarding medicines, medical devices and clinical trials. This has wide-reaching powers for the government to introduce a second legislation to amend the UKMDR 2002.

The MHRA is the UK’s competent authority and has been tasked to design, consult and implement new legislative framework which will support safe innovation and encourage developers to bring products to the UK market. The consultations is expected to be published by the end of October this year with relevant statutory instruments due by quarter 2 2022.

The plan was published on the 4th of July and stated how the MHRA want to retain and build on the safety and efficacy part of the legislation, but make the UK a very appealing market to prospective investors. They want to remove difficult red tape, without diminishing patient safety. The plan laid out 14 objectives, grouped into the six themes of: scientific innovation, healthcare access, patient safety, dynamic organisation, collaborative partnerships and financial sustainability.

The easy business environment and tax advantages of UK business – James Oury, Founding Partner, Oury Law

James is an British lawyer based in the USA who is also involved in building and scaling medical device companies.

Setting up a UK company is similar to setting up a C CORP or an LLC, and the process can be completed in about a week. You have non-resident directors, meaning directors can be based in the US, and the minimum capital needed is £1. It’s easy to set up and there are clear guidelines on directors’ duties.

Once you have set up a UK company, you have a vehicle that within the UK is seen as having a trading presence, which will make a significant difference in business development conversations and conversations with regulators.
The current tax rate in the UK is 19%, but there is an additional relief for MedTech companies. It is a research and development relief which is based on the idea of solving a technical uncertainty. If you meet the definition, you are entitled to claim £33 back in every £100 that is spent on eligible research. There does need to be a genuine reason to claim the relief, but your intellectual property and research teams don’t need to be based in the UK. Effectively, this means that you can have some of your research and development spending given back to you.

Enter the UK market with your medical device

Not only will entering the UK health care market set you up for your adoption journeys in the rest of the world, changes in the regulatory landscapes means that it is becoming easier than ever and tax reliefs mean that you can save money for doing the research you are already doing.

You can listen to the full webinar recording as a podcast, or view the session and Powerpoints on Youtube.

If you would like to talk to us more about your medical technology, you can contact us for a free consultation.

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