At the recent British Healthcare Trades Association (BHTA) Conference 2024, Laura Squire, Chief Healthcare Quality & Access Officer at Medicines and Healthcare products Regulatory Agency (MHRA), discussed where UK medical device regulation is at now and what the future looks like.
The BHTA Conference 2024 focused on the UK healthtech landscape over the next five years. It was a chance for BHTA members to hear from senior government and NHS speakers about how the changes made today will impact the future of the health service.
Laura began by explaining the MHRA’s purpose in delivering the future regulatory framework of medical devices in the UK. Its goal is to deliver a robust and leading regulatory framework that prioritises patient and public safety. In delivering this regulatory framework, the MHRA’s chief goals are to deliver:
The new regulatory framework has been implemented via a series of Statutory Instruments (SIs), Laura explained. Further details are in the slide below.
Laura also provided details of where MHRA is at now with UK medical devices regulation and plans for 2024-2025. The slides below provide more information.
“We’re trying to be more transparent about our timescales,” Laura commented. “But it’s very difficult to be transparent about timescales when you’re doing legislative work, because there are certain things that are not within our gift in terms of timescales.”
A key point from Laura’ presentation was around international recognition. MHRA recently published a statement of policy intent, which outlined MHRA’s intention to recognise medical device approvals from Australia, the EU, Canada, and USA. It contained further details for the access routes depending on the device type, class, and prior approval.
“We are also working actively with Japan to bring them into the international recognition,” added Laura. “It’s slightly more complex there because of the population and understanding how they apply some of the international standards, but there is no doubt that Japan is a rigorous regulator, so we would trust it.
“We’re calling these comparable regulators, because I don’t like the phrase ‘trust’. It implies we don’t trust everybody else, and we do trust quite a lot of other regulators. It’s about the practicalities of making it work. At the moment, these countries are the ones that we think we can get to work, and we’ve worked with all these countries to try to design the framework.”
MHRA is testing the proposed framework in collaboration with industry and approved bodies, using a range of devices with existing approvals from these countries. Market access via international recognition would only be formally granted once the future core regulations are in force, Laura explained. The proposed framework may be updated based on these activities.
At the recent British Healthcare Trades Association (BHTA) Conference 2024, Barney Willis, Deputy Head of Life Sciences at the Department for Business and Trade (DBT), explained how DBT provides practical support to UK medtech SMEs with exporting.
The BHTA Conference 2024 focused on the UK healthtech landscape over the next five years. It was a chance for BHTA members to hear from senior government and NHS speakers about how the changes made today will impact the future of the health service.
Barney began by explaining what the DBT does. The department brings together business and trade in a single department. Export and investment are the two pillars of the department. DBT also opens up new markets for businesses by removing barriers and negotiating trade deals, which can lead to practical opportunities opening up.
Barney provided some insightful UK medtech sector statistics. See them in the slide below.
Despite the UK having an innovative, productive, and fast-growing medtech sector, UK medtech exports are low relative to international comparators, he said. The UK imports more than it exports.
The key point from Barney’s presentation is that the DBT provides practical advice and support to SMEs to help them grow and export, which involves non-stop engagement. Barney outlined some of the practical support available to SMEs in the slide below.
Barney said: “We will competitively recruit between 10 and 14 companies, which will be UK SMEs that have got something competitive that we think has a chance of being successful in an overseas market.
“For example, I’m flying to Saudi Arabia with about 10 companies, which we recruited from across the assistive tech and medtech sectors, and we will use the convening power of the British Embassy to get them into rooms they wouldn’t otherwise get into.”
Importantly for SMEs, DBT has a network of international trade advisers across the south, midlands, and north of England, Barney explained. These advisers provide businesses with free and impartial export support. Additionally, they can help firms develop their export strategy, access masterclasses, link firms to specialist export advisers, and help firms make the most of DBT’s global network so they can grow their business overseas.
DBT’s overseas network spans over 100 markets with a global reach in more than 170 countries. These include Canada, the US, Germany, UAE, Japan, Spain, New Zealand, China, and more.
Barney added: “DBT has embedded staff in most of the markets you’re likely to care about, and certainly the large ones. These will be, in many cases, specialists who know the sector in their country. They will often be locally engaged.”
At the recent British Healthcare Trades Association (BHTA) Conference 2024, Mark Chapman, Interim Director Medical Technology Digital & Diagnostics at the National Institute for Health and Care Excellence (NICE), delved into the NICE healthtech assessment lifecycle approach and innovative vs iterative healthcare products.
The BHTA Conference 2024 focused on the UK healthtech landscape over the next five years. It was a chance for BHTA members to hear from senior government and NHS speakers about how the changes made today will impact the future of the health service.
Mark began by explaining how NICE is transforming by developing guidance that is more:
Progress has been made on these changes, which are detailed on the slide below.
An important topic from Mark’s presentation was around whether products are innovative or iterative.
Mark said: “A product starts off massively transformative and innovative. Then, over time it iterates. By the end, it’s got a lot of additional items added to it. It’s the additional items that make it different to the predecessor, but you wouldn’t class it massively as innovative.
“The reason why it’s important to think about this is, for so many years, we’ve tried to polish what may just be another pair of shoes and convinced someone that they’re the better thing to have. That might be the case, but it’s not always the case.”
The MedTech Strategy touches on the right product for the right patient at the right time.
“When we think about innovation without differentiation, that’s what holds us back,” Mark explained. “Far too often, innovation has gone into the system, and the next innovation has come along. You don’t know whether the first one was the game-changer or the second one was the game-changer, because we’ve rarely done any full assessments.
“That’s what we want to shape NICE to be looking at more intentionally.”
With this in mind, NICE has introduced and refreshed its topic prioritisation programme. This allows NICE to select the right technologies for consideration of a NICE assessment, dependent on the evidence, availability, the access to it, and the need in the health and social care system.
Then, through various stages, NICE will start looking at how much this would cost, the system impact for that investment, population impact for that investment, and these may be cost saving. Whereas historically in the healthtech programme, everything was forced into proving cost saving.
“Once a product has been selected, we’ll embark upon a health technology assessment,” continued Mark. “A health technology assessment is a collective term that describes a set of methods and approaches to assess the value proposition of a technology.”
A key point from Mark’s presentation was around NICE’s life cycle approach to healthtech assessments. See the slide below for further details.
Where possible, real-world evidence (RWE) will be prioritised for late-stage healthtech assessments, added Mark.
At the recent British Healthcare Trades Association (BHTA) Conference 2024, Andrew New, CEO of NHS Supply Chain, explored how NHS Supply Chain will change over the next five years to make it better to work in and with.
The BHTA Conference 2024 focused on the UK healthtech landscape over the next five years. It was a chance for BHTA members to hear from senior government and NHS speakers about how the changes made today will impact the future of the health service.
Andrew explained the fundamentals of the organisation: “NHS Supply Chain exists to try to simplify the way marketplaces work; to try to engage trusts on a collective basis so we get consistent decision-making, and it’s not sporadic as it has been historically; and to make these markets work more effectively.
“We’ve been doing a lot over the last year or so to reorganise the way we work at the same time as continuing to run very fast in delivering the benefits that all of our supply base offer to the NHS. None of this can be done without the whole system working together, and that’s a key principle of everything we’ve done.”
Andrew highlighted that NHS Supply Chain initially started out doing a fantastic job of focusing on what it was asked to do but not doing the job the NHS needs in the future. The slide below details some of the areas where NHS Supply Chain has built on solid foundations to ensure it is fit for the future.
In one year, NHS Supply Chain and suppliers have achieved a lot, Andrew explained. Headline achievements include:
He underlined that there is an opportunity to save £40 million across the NHS, but there is a backlog of work, and it requires clinical intervention.
Andrew shared NHS Supply Chain’s strategy and corporate priorities. See the slide below for further details.
One key point from Andrew’s presentation was around NHS Supply Chain’s work to enhance the clinical voice across the organisation.
“We need to enhance that voice both in the conversations we have with trusts as well as with suppliers,” he continued. “We’ve brought in a new national clinical director, Michelle Johnson, who is bringing together a clinical community to make sure we have clinically led decision-making everywhere. That is hugely valuable to us as an organisation, and we’re already seeing the benefits.”
NHS Supply Chain is going to clinically segment products in terms of priority, importance, value, and making a difference in healthcare outcomes. The organisation also wants to simplify prices so that there are not 10 different prices for the same thing.
See the slides below for an outline on the work NHS Supply Chain is doing to transform its commercial capabilities, strengthen the supply chain, and improve processes.
At the recent British Healthcare Trades Association (BHTA) Conference 2024, Fiona Hilton, Director of Commercial Best Practice & Engagement for NHS England, discussed The Procurement Act 2023 and the Strategic Framework for NHS Commercial.
The BHTA Conference 2024 focused on the UK healthtech landscape over the next five years. It was a chance for BHTA members to hear from senior government and NHS speakers about how the changes made today will impact the future of the health service.
Fiona highlighted the NHS Commercial portfolio and how it all links together. This revolves around four central initiatives: the NHS Central Commercial Function (CCF) service offers, the Commercial Efficiencies Programme, the Procurement Act, and the Strategic Framework for NHS Commercial. See the slide below for further details.
“We’re trying to link the NHS much more into how the whole of central commercial government works, so that we can collaborate and engage with some of the standard practices that are already in place,” Fiona said.
One key point from Fiona’s presentation is that healthcare procurement is set to transform in 2024 with the introduction of two new procurement regimes: the Procurement Act 2023 and the Provider Selection Regime (PSR).
Fiona emphasised that the NHS believes that the Procurement Act 2023 is key to transforming procurement in the medtech sector. The Act will go live on 28 October 2024.
“We believe that the Procurement Act is a fundamental catalyst to enable change,” added Fiona. “It’s really key for us to be able to establish what we want to do on innovation, working with SMEs, and enabling greater transparency with our suppliers.”
The Procurement Act 2023, she said, will introduce a new competitive and flexible procedure that will enable the NHS to work innovatively and faster with suppliers. It simplifies the regulations that govern public procurement and promises increased commercial flexibility.
Additionally, within the Act, the Competitive Flexible Procedure will allow contracting authorities to design processes that best suit their needs, rather than follow suboptimal standardised procedures.
Importantly, Fiona stressed that the Act will give the NHS an enhanced to take into account poor performance suppliers and the potential debarment of those that do not improve, which will help the NHS improve outcomes.
Additionally, Fiona encouraged medtech suppliers to become familiar with the PSR, which launched in January 2024. It represents a new set of rules governing healthcare services in England. The PSR exempts healthcare contracts from the formal public procurement regime. Fiona added that the regime enables a more flexible, proportionate process when awarding healthcare contracts.
Another important topic from the presentation was around the Strategic Framework for NHS Commercial, which aims to be globally renowned, supporting the delivery of the world-class Commercial Function in healthcare, in patient care, and in outcomes. See the slide below for more information.
Fiona explained: “The Strategic Framework was put together originally in order to be able to support the whole of commercial healthcare for outcomes, not just about value for money upfront. It was about benefitting the whole of the life cycle, and the outcomes across all of commercial.”
At the recent British Healthcare Trades Association (BHTA) Conference 2024, David Lawson, Director of MedTech for the Department of Health and Social Care (DHSC), presented an engaging presentation on value-based procurement and a MedTech Strategy update.
The BHTA Conference 2024 focused on the UK healthtech landscape over the next five years. It was a chance for BHTA members to hear from senior government and NHS speakers about how the changes made today will impact the future of the health service.
In his presentation, David remarked that it is a very active time in the procurement and medtech sectors, and that there is a genuine desire for DHSC to engage with industry, including BHTA members, to ensure its proposals are grounded and well thought-out.
David reflected on the ‘The medical technology strategy: one year on’ report, which reflects on the MedTech Strategy and provides an update on where the medtech sector is headed. Since the MedTech Strategy was published, there are multiple medtech initiatives in flight, such as the Innovative Devices Access Pathway (IDAP).
One of the central themes in David’s discussion was around value-based procurement. He stressed that the lowest price does not always equal best value.
He also highlighted some of the key problems DHSC is trying to solve in the medtech sector. See the slide below.
One issue David particularly emphasised with evaluating procurement is around validating evidence submitted by suppliers.
He said: “Can we believe the claims from industry? How do we validate that? How do we trust the information? Having good data is part of that validation process.
“At the moment, there’s an absence of clarity in terms of validation. That leads to a lack of consistency. Different trusts across the country apply value-based procurement assessment of medtech in different ways. There isn’t a methodology to set a common way of doing this. That makes it inefficient for everyone.
“It’s quite difficult to do validation on medtech, because medtech doesn’t stand still. A product is developed, it then gets iterated, more data is collected, and more evidence is collected. It’s quite hard to make a validation process that’s dynamic and that reflects the way that medtech operates, alongside the scope and scale of medtech.”
David underlined that it may take a while for DHSC to come up with an appropriate, robust, and sustainable process for validating medtech.
In addition, David outlined potential options to move work forward. See the slide below.
David said: “This question about validation of evidence, our thinking at the moment is that we need a system solution. We need some sort of portal where suppliers can submit their information, there’s a validation process, and it can be updated.”
Moreover, David underlined some of the key issues DHSC is trying to iron out to make the medtech sector work more seamlessly. See the slide below.
“From a UK perspective, the majority of our medtech industry is SME-based, so we need to make sure that at a government level and a system level that we are doing everything we can to support SMEs, not make it harder,” he commented.
The British Healthcare Trades Association (BHTA) recently hosted another successful conference that brought together healthcare leaders and suppliers to discuss how the changes made today will impact the future of the health service.
The sellout BHTA Conference 2024, ‘Health Tech in the UK: The next 5 years’, took place at the Northampton Town Centre Hotel on 21 May and was sponsored by Verlingue.
Boasting an impressive roster of key government and NHS speakers, engaging presentations throughout the day included topics on the MedTech Strategy one year on, the Procurement Act 2023, late-stage medical device assessments, practical export support for UK SMEs, UK medical device regulation changes, and much more.
Attendees had the chance to ask the speakers important questions during two Q&A panel discussions throughout the day.
The conference kicked off with a welcome from BHTA CEO David Stockdale, who highlighted some of the BHTA’s successful campaigns, how the BHTA lobbies to government to ensure its members’ voices are heard, and an overview of the BHTA Conference 2024.
Next, Lord Markham, Parliamentary Under-Secretary from the Department of Health and Social Care (DHSC), shared his opening remarks. Lord Markham outlined that the UK has massive potential to transform the medtech landscape over the next five years and highlighted relevant and successful government initiatives like Innovative Devices Access Pathway (IDAP), the MedTech Strategy, and late-stage medtech assessments.
David Lawson, Director of MedTech for DHSC, delivered a presentation titled ‘Value Not Cost’. He discussed the ‘The medical technology strategy: one year on’ report, the issues DHSC is trying to solve when it comes to the medtech sector, and value-based procurement.
Fiona Hilton, Director of Commercial Best Practice & Engagement for NHS England, discussed the Strategic Framework for NHS Commercial. Her presentation delved into how the Procurement Act 2023 will significantly change how the NHS works with suppliers and the Strategic Framework for NHS Commercial.
Andrew New, CEO of NHS Supply Chain, presented ‘One Year On – More to Come’. He talked about how NHS Supply Chain will change over the next five years to make it better to work with, and how it aims to enable an optimised, resilient, and sustainable supply chain.
Mark Chapman, Interim Director Medical Technology Digital & Diagnostics at NICE, commenced the afternoon presentations. His presentation was titled ‘NICE HealthTech Assessment: Focus on What Matters Most’. Mark explained the NICE HealthTech Assessment lifecycle approach and late-stage medical device assessments.
Barney Willis, Deputy Head of Life Sciences for the Department for Business and Trade (DBT), explained how DBT provides practical support to UK medtech SMEs with exporting. Barney provided an insight into how DBT promotes innovative UK medtech companies in key global export markets.
Before the closing remarks, Laura Squire, Chief Healthcare Quality & Access Officer at Medicines and Healthcare products Regulatory Agency (MHRA), delivered the final BHTA Conference 2024 presentation. Her talk, ‘How Regulation of Medical Devices in the UK is Changing’ explored where UK medical device regulation is at now and what the future looks like, alongside international recognition of medical devices.
Positive feedback from the day included:
“An excellent set of speakers and some thought-provoking questions. Given the make-up of BHTA membership, it was good to see several references to the importance of SME business from the speakers.”
“A very good event with really good Q&A sessions. The speakers and the topics they covered should have been of real value to members. I always go looking for 3 or 4 golden nuggets at a day like this, and there were several.”
“It was a really informative day, great speakers, content, location, room, and lunch.”
“It was obvious from how well it went that a lot of work has gone into it, so I hope all the team involved are justifiably proud of the day.”