Recently, leading medtech suppliers had the chance to attend the British Healthcare Trade Association (BHTA) conference, ‘UK Health and Social Care Landscape: How will UK policy decisions impact patient experience?’.
Both BHTA members and non-members were invited to the spring conference to discover how current policy decisions are shaping the future of health and social care, impacting UK patients, and what this change means for businesses.
Sponsored by Verlingue, the sell-out conference took place on 11 May 2023 at the Manor Hotel in Meriden, Solihull.
The conference saw an impressive roster of senior government and sector leaders present engaging sessions throughout the day to suppliers about future policy directions, new UK Government priorities, and how collaboration and innovation will ultimately improve the patient experience.
Attendees gained invaluable insights into the changing health and social care landscape, asked questions to the high-profile speakers, and networked with key stakeholders and peers.
Below are the highlights from the afternoon sessions from David Lawson, Director of MedTech; Purvi Patel, BSI Regulatory Lead for Medical Devices & IVDs; and William Lee, BHTA Head of Policy & Compliance.
Topics in these sessions included tackling procurement inconsistencies, keeping up government engagement with the medtech industry, and the complex UK regulatory landscape regarding medical devices.
The first set of morning presentations from David Stockdale, BHTA CEO; Steven Ferguson, Head of Market Access at IQVIA; and Paul Gaffney, Director of Tendo Consulting, can be found here.
These sessions explored how the BHTA is successfully lobbying on behalf of its members, how tackling NHS waiting lists with innovative technology is a priority, and how the changing political landscape is impacting healthcare policy.
The second set of morning talks from Simon Williams, Local Government Association Director of Social Care Improvement, and Alan Wain, COO at EPSCOT can be read here.
These presentations looked at social care reform, how better use of technology could improve the lives of millions of social care users, and how social value in public procurement impacts suppliers.
David Lawson, Director of MedTech, discussed the UK MedTech Strategy and its implementation plan.
He reinforced a key theme that was discussed throughout the conference: that innovation adoption within the healthcare sector is an immediate priority. There is lots of opportunity in medtech and a sense of urgency in the sector to tackle NHS issues.
“When I’ve spoken to people in the industry, NHS England, NHS Supply Chain, MHRA, NICE, and life science, my sense is there’s a general consensus about what the challenges are in medtech,” he commented. “There’s also a consensus about potential solutions. The challenge is trying to get things done.”
David reflected on what he presented at the BHTA Integration and Sustainability Conference 2022 in September last year. One of the things he discussed at that event was about a commitment to industry engagement from the Department of Health and Social Care (DHSC).
“I feel that has been quite positive for me to get different views, meeting with different suppliers, and meeting with the BHTA numerous times,” he said. “I’m keen that I keep that engagement up.”
The UK Government’s priorities are technology as an enabler and the importance of the life science industry. David highlighted that the Secretary of State sees medtech as a key priority and a solution to the NHS’ challenges, especially in regard to innovation adoption. The government also sees medtech and life sciences as an opportunity for growth in the economy.
“If we look at the Autumn Statement from last year, the Chancellor announced additional funding for MHRA to support them under their regulatory reform work and provide immediate access in terms of innovation,” he explained. “It’s unusual for a chancellor to talk about medtech in an Autumn Statement, but it reflects the fact that politically medtech has got quite a lot of momentum behind it.”
David noted challenges have been raised by industry around procurement inconsistencies, such as social value, inflation, and net zero. This is creating frustration within industry, as it means suppliers have to keep taking different approaches to tenders.
A key catalyst for improvement in this area, he said, is the NHS Central Commercial Function (CCF). He pointed towards Jacqui Rock, who is the chief commercial officer for NHS England and the CCF.
“There is a lot of leadership now in the system at that level that recognises these challenges and wants to engage and sort them out,” he continued. “Jacqui’s been having forums around SMEs, social value, and other areas. Jacqui is in an ideal position to drive improvement across the procurement landscape.”
David added that there is an issue with adopting innovation at scale in the NHS.
“This is an area of genuine frustration when you’re shown around hospitals where there’s great medtech solutions and you ask when they’re being deployed across the country and they don’t have an answer,” he explained. “We’re passionate about solving the adoption problem.”
He also recognised that the innovation pipeline for medtech is not joined up and there is a lack of clarity about what the process is. This is an area of particular focus for getting greater clarity of the process in terms of innovation adoption.
“For new innovations coming through,” he added, “how do we assess them and how do we make informed decisions? Once we’ve made the right impact, how do we get through levels of reimbursement and adoption?
“For solutions already on the market, how do we make important decisions about assessment and clarify the adoption of the most effective products in the market?”
David also delved into the MedTech Strategy, emphasising that it is centred around the vision of “right product, right price, right place”.
“The right product is about what is the most effective product to use?” He commented. “The challenge with medtech is that there are half a million medical devices being used in the UK. How do we measure what is the most effective products to use?
“Right price is about value-based healthcare. How do we understand the impact of products on patient outcomes? How do we get consistency across this area?
“Right place is partly about resilience but also about equity to access as well.”
The delivery of the strategy is led by different agencies: NICE, DHSC, NHSE, NHS Supply Chain, and MHRA. David said a key goal is about aligning this collaborative work across the agencies.
He explained: “For example, product evaluations are led by NICE. What we want to do is make sure there’s a connection between what NICE do with NHS England from a commissioning perspective but also if there are class-based evaluations impacting on products that NHS Supply Chain manage that the outcomes of those assessments feed into the category strategy and relations that the supply chain has. Otherwise, what’s the point in doing it? It’s about having a joined-up approach to tenders.”
David also discussed the strategy’s part IX tariff and its three areas of focus: the ability to review listed products, the assessment process to list products, and prescribing practice (second phase). A targeted consultation is due to come out at the end of July 2023 on part IX of the MedTech Strategy.
Purvi Patel, BSI Regulatory Lead for Medical Devices & IVDs, spoke about the UK regulatory landscape regarding medical devices.
She said that Brexit has had a big impact on the UK medtech regulatory landscape. Placing a medical device on the GB market with the UKCA mark is now mandatory from 1 July 2025; anything that is CE-marked and placed on the UK market is valid until 30 June 2025, after that point, medical devices need a UKCA mark.
“That’s through registration with the MHRA, having a conformity assessment done through an approved body, and then you’re able to place your device on the GB market,” commented Purvi.
“If we look at Northern Ireland, the route BSI offers for placing medical devices on this market, as an approved body, is the CE mark. There is something called the CE+UKNI mark. That’s not something that BSI offers because the UKNI mark isn’t recognised by the EU.”
She continued: “There was a change in March 2023. The European Journal published a legislation – 2023/607 – and this is dealing with those devices that have been certified under the directives having an extension granted with the timelines of 31 December 2027 for Class III devices or IIb implantables that are not well established technology, which are allowed to be, under the directives, on the market until 30 June 2028.
“So we have the EU timelines with what’s valid under the directives up until 2027/2028, but then we also have now the UK legislation saying that we have until the 30 June 2028 for medical devices complying with the new UK legislation. Then 30 June 2030 by which we need to have IVDs complying with the new UK legislation.”
This has caused complexity for medical device manufacturers around: what they need to do with their directive certificates, because they’ve got extended validity now based on certain conditions; what to do with devices that are certified under current UK legislation; and thinking about future UK legislation and timelines.
“To place devices on the UK market, you need to have registration with the MHRA, a declaration of conformity, UK designated standards, an appointed UK responsible person, and labels showing a UKCA mark or CE mark,” she added. “Those are the extra UK requirements.”
Purvi helpfully explained what conformity assessment looks like for UKCA at BSI and detailed various scenarios:
“The other two options are if you combine the applications,” Purvi continued. “We do see applications where manufacturers have got their MDR assessment in and they’re formally applying for a UKCA certification at the same. We would follow the MDR certification processes look for the UK-specific requirements as well – we’d assess that at the same time – so we’d do things like combine the QMS audits and combine microbiology audits.
“The final scenario is if you’ve got a combined application with UKCA with IVDs – so if you’ve got a certificate under the IVDR and you’re looking for UKCA certification, which we’d leverage off the IVDD – we’d combine the QMS audits and the microbiology audits, but we’d have to do standalone technical documentation reviews because of the differences in classification with the IVDs between the directives and regulations.”
Purvi explained that there are three lists of designated standards in the UK: medical devices, IVDs, and active implantable medical devices. These standards can be found on the UK Government website.
She then discussed UKCA placement on medical devices.
In Great Britain, UKCA placement needs to be on the device or on the sterile pack (where appropriate), any sales packaging for the device, and instructions for the device. For products being placed in Northern Ireland and the EU as well as in Great Britain, both the CE mark and UKCA mark will need to be placed on the medical device.
Importantly, she reminded firms that they need to approach BSI as early as possible when getting devices UKCA marked because it is very busy and capacity is not limitless.
The last presentation of the day was delivered by William Lee, BHTA Head of Policy & Compliance.
He noted that while the MHRA aims for new medical device regulations to be in place for 1 July 2025 in its guidance, this date does not appear in statutory instruments (SIs).
Bill also discussed medical device transitional arrangements.
“The transitional arrangements have changed slightly,” said Bill. “CE-marked devices under the EU MDR can, under certain conditions, stay on the GB market until the new regulations take effect, i.e., 1 July 2030. It seems clear that MHRA intends to make a further change that would mean that you needed to apply the phrase ‘whichever is sooner’ under the EU MDR.
“Similarly, medical devices CE-marked under the EU MDD can stay on the GB market for three years, under certain conditions, after the regulations take effect, which takes us up to 2028.
“Our understanding was that the previous transitional arrangements applied to all classes of medical devices.
“I think the biggest change and the most relevant change for BHTA members is that for Class I products that do not require third-party conformity assessments – so standard Class I products that aren’t sterile, don’t have a medical function, and that aren’t reusable surgical instruments – the new transitional arrangements will not apply. These Class I products will need to comply with UK regulations and display the UKCA mark from the new date of inception.”
Bill explained that the SI has been laid before the House of Commons and the House of Lords in a draft affirmative. If the medical device SI is approved, it passes into law on 30 June 2023.
BHTA is currently seeking clarity from MHRA regarding the 1 July 2025 inception date, Class I device transitional arrangements, labelling requirements, and securing MHRA guidance webinars for members.
The association will issue a guide to BHTA members on UK medical device regulation and laws in the coming weeks.
Last month, the British Healthcare Trades Association (BHTA) invited members and non-members to its spring conference to discover how current policy decisions are shaping the future of health and social care, impacting UK patients, and what this change means for businesses.
The sell-out conference, ‘UK Health and Social Care Landscape: How will UK policy decisions impact patient experience?’, took place on 11 May 2023 at the Manor Hotel in Meriden, Solihull.
Sponsored by Verlingue, the conference saw an impressive roster of senior government and sector leaders present engaging sessions throughout the day to suppliers about future policy directions, new UK Government priorities, and how collaboration and innovation will ultimately improve the patient experience.
Attendees gained invaluable insights into the changing health and social care landscape, asked questions to the high-profile roster of speakers, and networked with key stakeholders and peers.
Below are the highlights from the other two morning sessions from Simon Williams, Local Government Association Director of Social Care Improvement, and Alan Wain, COO at EPSCOT.
Topics covered by these two presentations included social care reform, how better use of technology could improve the lives of millions of social care users, and how social value in public procurement impacts suppliers.
The first set of BHTA morning presentations from David Stockdale, BHTA CEO; Steven Ferguson, Head of Market Access at IQVIA; and Paul Gaffney, Director of Tendo Consulting, can be found here. These sessions explored how the BHTA is successfully lobbying on behalf of its members, how tackling NHS waiting lists with innovative technology is a priority, and how the changing political landscape is impacting healthcare policy.
The remaining afternoon presentations from the conference will be shared on the BHTA website and social media over the coming days.
Simon Williams, Local Government Association (LGA) Director of Social Care Improvement, gave an overview of the LGA’s perspective on social care.
He underlined that there are millions of social care users whose lives could be improved by better usage of technology. It has a huge role to play in tackling social care challenges and realising the sector’s vision.
He advised that technology needs to be accessible to staff without going through formal assessments and that it should help properly reduce the need for intensive staffing or deploy staff more efficiently.
“Social care is a priority for government and the NHS because the NHS is saying it is not going to be able to find the capacity to get on top of its waiting lists unless there is investment in social care,” Simon noted.
People are unnecessarily admitted into hospital, as there are not reliable alternatives. People stay in hospital for too long as the right solutions are not in place in their homes. Often, people are admitted into care homes instead of going home because the right solutions are not in place, he added.
818,000 people receive adult social care through local authorities. Most spending on social care is made via tax. With all this pressure within the social care sector, especially post-COVID, councils are looking for ways to make savings and meet user needs.
Simon continued: “There has actually been a decline in the number of people who receive long-term care through local authorities, and that particularly affects older people. That’s despite our ageing population.”
LGA estimates that £13 billion is needed to get social care on a sustainable, long-term footing.
Workforce pressures were also highlighted in Simon’s presentation, as he stated that there are currently 165,000 vacancies in the social care sector. Social care is now on the shortage occupations list for immigration.
“Vacancy levels are a massive constraint on meeting demand at the moment, particularly care,” he said.
Simon then moved on to a discussion around social care reform.
As part of this, since April 2023, councils are subject to CQC assessments for their adult social care function for the first time since 2010. That has been brought in primarily because the government says it is going to be delving more into care and there needs to be more transparency around outcomes.
Importantly, Simon explained that the upcoming social care charging reform – which has been pushed back from October 2023 to 2024 at the earliest – would have major consequences for how the care market operates.
“There will be a cap on how much anyone is expected to contribute to their own care,” he said. “Councils have changed the thresholds in which charging applies, so there will be more generous thresholds before people are asked to contribute to their own care or pay for all of it.
“Then there’s the duty on councils to assess self-funders, who ask councils to assess for their care. One of the key issues on that last point is that will potentially erode the differential between providers. Typically, providers will charge more to their self-pay market than to their local authorities. As this duty comes in, you can see that differential being eroded.
“Either providers are going to be squeezed, and I don’t think there’s a lot of profit in many providers to be able to support the loss of that differential. Or local authorities are going to have to find the money to put into that. Then the question is who’s going to pay for that?”
Alan Wain, COO at EPSCOT, presented next at the BHTA spring conference 2023. His session was all about the importance of social value in public procurement.
All public NHS tenders must now have a minimum of 10 percent of the total award scoring to social value, he outlined. This is a significant step change from the traditional price and quality criteria.
“Now that social value has come into it, price and the social value will be taken into account in the evaluations,” Alan explained. “Social value encompasses a lot of initiatives that are going on in society at the moment, such as sustainability, corporate social responsibility, ESG, wellbeing, carbon reduction planning, and so on.”
“The implementation of social value is really about generating additional value in UK plc,” he added. “It’s not about generating additional value in the organisations themselves, it’s about UK plc.
“When social value is being measured, there are two things people are looking at. One is what I call the ‘rear-view mirror’, which asks companies: What are you already doing around social value? And then comes the forward-looking bit: What are you prepared to commit to if you get this contract that’s being awarded?
“The backwards bit is looking for evidence that you’re already doing it and really that supports the credibility of the forward-looking bit.”
Alan said it is important for firms to look at what contracting authorities want when tendering so their proposition is relevant.
He continued: “For you, as an organisation, when you look at what social value touches on, it touches on all parts of your organisation. It goes across all the functions of your organisation. Whereas, when you were looking at price, it may not have quite gone across all the same functions.
“It also goes outside of your organisation. Social value guidance talks about collaboration, using SMEs, and using innovation to make your own products and processes better.”
Large organisations will need to provide data about how many SMEs they work with and what percentage this accounts for in terms of total cost. This data needs to be collected, so organisations can answer these questions sensibly.
In operations where manufacturing occurs in the UK, Alan noted that a lot of manufacturing operations are not doing a lot in their local communities, or it is not recorded anywhere. This data is also important for tenders.
Looking outside of the organisations, NHSE’s net zero targets are very significant in public procurement, including reducing emissions within the supply chain and not just within the organisation.
He underlined that NHS net zero guidance states that the carbon footprint of third parties needs to be removed by 16.5 million tonnes CO2e from supply chain. Scope 1 emissions are direct emissions, scope 2 emissions are indirect emissions, and scope 3 emissions are supply chain emissions.
“Current carbon reduction planning only asks you account for 5 out of 15 scope 3 emissions,” he commented. “Where are the other 10 going to come from? The other 10 get more challenging.”
When EPSCOT did the calculations for tender evaluations, if companies are not accounting for the minimum 10 percent social value, the product’s price must be significantly lower to get the same evaluation score, which would significantly impact suppliers’ gross margins.
Alan added that implementing social value is about improving UK plc. He said social return on investment (SROI) tells a story of how change is being created by measuring social, economic, and environmental outcomes. However, he nodded to the fact that the UK Government’s social value guidance is complex and open to interpretation.
To help with social value, EPSCOT has an affordable social value tool available, which makes it easier for suppliers to quantify the impact of their social initiatives and insights for improving future strategies.
On 11 May 2023, the British Healthcare Trades Association (BHTA) brought together key healthcare leaders and suppliers at its spring conference to discover how current policy decisions are shaping the future of health and social care, impacting UK patients, and what this change means for businesses.
The sell-out conference, ‘UK Health and Social Care Landscape: How will UK policy decisions impact patient experience?’, took place at the Manor Hotel in Meriden, Solihull and was sponsored by Verlingue.
It saw an impressive roster of senior government and sector leaders present engaging sessions throughout the day to suppliers about future policy directions, new UK Government priorities, and how collaboration and innovation will ultimately improve the patient experience.
Both BHTA member and non-member companies were invited to the conference to gain invaluable insights into the changing health and social care landscape, ask questions to the high-profile roster of speakers, and network with key stakeholders and peers.
Below are the highlights from the first set of morning presentations from David Stockdale, BHTA CEO; Steven Ferguson, Head of Market Access at IQVIA; and Paul Gaffney, Director of Tendo Consulting.
Topics covered in the first set of morning sessions included how the BHTA is ensuring its members’ voices are heard by government, the NHS’ readiness to adopt innovative technologies, and how the changing political landscape is impacting healthcare policy.
The remaining presentations from the conference will be shared on the BHTA website and social media over the coming days.
Kicking off the BHTA’s spring conference 2023 was the CEO, David Stockdale. After welcoming everyone to the event, David talked about how the association is striving to create, demonstrate, and deliver member value and underlined that membership is centred around what members want.
He explained that a big part of the BHTA’s work is lobbying and advocating for members on important issues.
“We’ll hear from Tendo this morning, who we’re working with really closely in terms of developing our political muscle,” said David. “We’re able to advocate better on your behalf at the highest level to government, get your voices heard, and make sure that we’re representing the industry and really have that foothold in current and future government and in the key parts of the health and social care sectors as well.”
Some of the association’s key goals are to develop more activity within its sections and to improve communication with members internally and with key stakeholders externally.
He added: “We’re looking at how to develop and modernise the Code of Practice to ensure that it’s robust and right for the world we’re now operating, as online continues to develop and become a bigger part of what we’re doing across the sections.”
Next to present was Steven Ferguson, Head of Market Access at IQVIA, a global clinical research organisation that compiles data and insights.
A big focus of Steven’s presentation was around the NHS’ readiness to adopt firms’ innovative technology. Medtech spends approximately £9.5 billion of the NHS budget.
While acknowledging that technology can make the NHS more agile, he explained that the NHS is not always good at adopting new innovations. Steven noted that sometimes the NHS is not ready for new technology, so quick “plug and play” solutions are sometimes required.
Firms need to have an understanding of the whole pathway of care for their technology to add value to the NHS. Technologies should address unmet local needs and challenges at an integrated care system (ICS) level, rather than firms submitting solutions for challenges and needs that are already being met, he explained.
When submitting solutions to the NHS, firms need to collect data to build an evidence base. This will make it more likely for their technologies to be adopted, Steven highlighted.
He prompted suppliers to ask themselves whether their products help people stay out of hospital. This should be part of firms’ strategies based on NHS data showing that it is struggling with patient backlogs.
Another big part of Steven’s discussion was around the headwinds, crosswinds, and tailwinds for the life sciences sector for 2023-2024 and beyond.
Headwinds for firms include post-Brexit challenges, COVID disruption, NHS workforce issues, economic instability, access, and HTA challenges.
“We’ve got about seven million people on waiting lists, and that’s not getting better,” Steven underlined. “Again, anything that companies can do to address that will get people interested.
“The NHS workforce, we all know about that. There’s about 20 percent of the workforce that are no longer here. That’s not going to change; we won’t be able to recruit our way out of this. This is about using technology and innovation. Anything where you can talk about where your innovation adds value to make things smarter is going to get you an audience with the NHS and with your stakeholders.”
Crosswinds for firms include new policy issues, regional devolution, and the post-Brexit conformity assessment mark (UKCA).
Tailwinds for firms include population health management and health inequalities, the NHS digital transformation agenda, NICE HTA methods, NHS resourcing, and virtual care wards.
Steven also discussed integrated care systems (ICSs).
He said: “At IQVIA, we’ve been tracking ICSs for the last 18 months to two years, before they became legal entities and now they are legal entities. We’ve been tracking their performance around who is new and who has been established for a long time. They’re all at different levels of sophistication and governance, so when you start putting out value propositions and communications, what might work in one area might not work in another area. We see a targeted approach working better.
“With the companies that we work with, their strategies are based around where the ICSs have got strengths and problems. It’s about understanding at a local level what the key priorities and struggles are for that ICS.”
Paul Gaffney, Director of Tendo Consulting, was next to present. He discussed the changing political landscape and the implications for healthcare policy.
Paul explained that the Conservatives are losing seats in local elections but that the opposition is split quite equally between Labour and Liberal Democrats. This means that planning for BHTA requires building relationships with Labour and Liberal Democrats, as well as Conservatives, Paul said, because he believes it is likely there will be a coalition government at the next general election.
He underlined that the BHTA perspective and engagement when approaching the elections and UK Government should be focusing on immediate issues and headlines around cutting waiting lists, workforce pressures, and Brexit issues.
He added that cutting NHS waiting lists will be a major topic at the general election, alongside discussions around innovation within the NHS.
“The other issue that will come up at the general election is social care,” Paul stated. “Nobody has a solution to social care.”
With all of this political change and major issues in the health and social care sector, BHTA has been increasing its presence and voice in the political space in the last six months.
“One of the things we did very successfully were the Parliamentary drop-in events,” he said. “BHTA members in the room emailed their MPs. A lot of them turned up. As a consequence, a number of MPs were greeted by the BHTA who discussed what their key issues were. A lot of people were interested in the MHRA issue. There were a lot of figures from the Conservatives and Labour that came in. It shows that there is a space for that.”
Paul continued: “I’d like to draw your attention to a Conservative MP called Henry Smith, who is the MP for Crawley. He will be an advocate for you if you’ve taken him round your sites. He’s already tabled a number of questions and written to ministers. If you are willing to do it [constituency visits], that is probably one of the biggest tools we’ve got in our arsenal.”
He added that the BHTA, and its members, should start thinking about what it wants from government, articulating this, and ensuring that its wants are deliverable.
“All politics is local,” continued Paul. “We need to work with you [BHTA members] to get to the MPs and candidates that we think will be influential. We need to influence all of the parties, and all of the parties’ policies, to make sure that we are covered.”
The three key pillars of political engagement are explaining what the association wants and why, how much it costs, and what the MP or government gets from it – i.e., if it is a political win, he concluded.