How has the HealthTech sector evolved over the past 20 years – is the NHS still slow to adopt innovation, and how have events such as COVID and Brexit shaped the current landscape? Louise Frampton spoke to the Association for British HealthTech Industries to discover what has changed.
The Association for British HealthTech Industries (ABHI) works with industry and the healthcare system to improve the lives of patients and overcome barriers to people benefitting from medical technologies. Over the past 20 years, the organisation has witnessed some major changes in the sector, in terms of innovation and regulation, as well as across political, economic, and healthcare landscapes.
So, how is the role of the ABHI changing to reflect these shifting priorities, challenges, and trends? Furthermore, how can we improve technology adoption, by removing barriers and bureaucracy, while addressing the changing demands of patients and the NHS? CSJ spoke to some of the ABHI’s leadership team to gain an insight…
The ABHI was set up 34 years ago, initially with regulation in mind – including the need to demonstrate compliance with European directives. Regulation is still an important focus for the organisation, but its remit has become more ‘integrated’ and ‘holistic’ to reflect the increasing complexity of the issues facing the HealthTech sector. During this period, the organisation’s focus has widened to include:
- Shaping how data and technology will transform healthcare and the lives of patients in the future.
- Working with the industry and the healthcare system to show the value of health technology.
- Informing regulation (as opposed to being reactive to regulation).
- Supporting sustainability.
- Enabling a vision of an early and holistic diagnosis healthcare model.
- Creating a positive environment that encourages growth through international trade and SME support.
- Promoting equality, diversity and inclusion within the sector.
“There are many issues that are interconnected; issues such as sustainability impinge on the supply of products, for example,” says Andrew Davies, ABHI’s digital health lead. “Everything is much more complex than it used to be…The only thing that hasn’t changed is that the NHS keeps changing.”
However, he points out that COVID and Brexit have had the most significant impact on healthcare, over the past 20 years, and have fundamentally changed the political, economic and healthcare landscape.
These two landmark events have also seen major changes to HealthTech regulation and the processes that surround it. Luella Trickett, ABHI’s director of value & access, explains that the whole industry went through major transformation in the lead up to the European Union Medical Device Regulation (MDR)
“This transformation is now coming to an end, but we have the UK Conformity Assessed Mark (UKCA) that will also deliver transformation from a regulatory perspective. It cuts across everything: what happens around sustainability; what you do with recycled materials and how you look at the circularity of medical equipment. But everything we do must have patient safety at the heart of it,” she comments
Phil Brown, ABHI’s director, regulatory and compliance, adds: “When the MDR first came out, you could tick box your way to regulatory compliance, but regulation has now become a business process. It is about keeping your product in the market because there is a need – regulation is just the facilitator. This is going to be increasingly the focus with the UKCA mark.
“However, there needs to be urgent action on completing the necessary legislative processes such that we have a clear roadmap for the future, and align messages to potential investors. The current deadline of June 2023 for a fully operational UKCA process remains in legislation but the date is ever more unrealistic.”
He points out that regulation became increasingly bureaucratic during the past 20 years. This demanded a lot more energy and personnel, and costs increased as a result. 20 years ago, a regulatory department would have had 2-3 people; today it will have 15-20.
The HeathTech sector is now seeing innovations that demand different regulatory inputs along with a variety of regulatory overlaps. However, one major factor that has changed the approach to regulation has been driven by COVID, which accelerated the process of collaboration.
“We saw a shift, not just around vaccines, but also for ventilators, and PPE to some degree. There was a recognition that innovative products were needed very quickly. As a result, there was a lot of collaboration between many different stakeholders – developers, clinicians, manufacturers, and even those who do not normally manufacture medical devices (such as Airbus, Rolls Royce and Maclaren), as well as the regulatory and conformity assessment bodies. There was a much more integrated approach to how medical devices reached the market. Those lessons are certainly being learnt for future regulatory pathways
“It is an exciting time for change, and it is moving in a positive direction. We are now seeing outcome-focused, collaborative processes to streamline and speed up pathways. COVID was really transformative,” Brown continues.
It is now 20 years since Sir Derek Wanless described the NHS as ‘a late and slow adopter’ of technology. Trickett points out that one of the issues around technology adoption is that “innovation is everyone’s job; therefore, it is nobody’s job.”
However, she points out that there have been significant efforts to address the problem over the years. The Accelerated Access Collaborative was established to try and support the adoption and spread of innovation. In 2021/22, the initiative claimed to have provided “over 575,000 patients with access to proven innovations”.
Fifteen Academic Health Science Networks (AHSNs) have also been established across England to spread innovation at pace and scale – with the aim of improving health and generating economic growth. Each AHSN works across a distinct geography serving a different population in each region.
NICE has also now appointed a MedTech director and there is increased recognition that more must be done in the non-pharma space, evidenced by DHSC establishing a Medtech Directorate. There has been some significant progress achieved in terms of technology adoption during the past two decades – we have seen advances such as additives manufacture, artificial intelligence and robotic assisted surgery. Many of these areas have accelerated in recent years,” Jonathan Evans, ABHI’s associate director, communications, points out.“Although many of these advances will have some years to go, before they have a higher level of adoption and spread, technology has come a long way,” he comments. “At the same time, much has stayed the same. We are always going to have a need for wound dressings, surgical scissors, and sutures.”
The response to COVID-19 has shown that, with the necessary set of conditions, the NHS can rapidly implement new technologies and ways of working – although digital technology adoption was already underway, enabled by scientific advances in wider society, such as extra computing power and genomics.
“This coincided with the wider digitisation of our everyday lives,” Davies explains. “Healthcare has lagged behind wider society and the acceleration, during the pandemic, has perhaps brought us ‘up to par’. Adoption of innovation has got better, but it is still far from perfect
“There are still too many unnecessary bureaucratic processes, repeated hundreds of times across the NHS,” Davies laments. He believes that the system and culture are not yet “where they need to be”
“There are some great individual organisations, but there is not a systematic approach to using innovation to tackle key health and care issues,” he comments.
Going forward, the ABHI is calling for every NHS organisation to appoint a board level Chief Innovation Officer to share the success of technological innovation, drive clinical and patient enthusiasm, and support required transformational change.
One of the major changes during the past two decades has been funding: “If you look back to New Labour times, we didn’t have waiting lists because they invested a lot of money and the approach was made more systematic by putting reimbursement in place,” Davies asserts
Trickett agrees that sometimes “it does come back to funding” but adds there also needs to be a change in mindset, towards value-based procurement.
“We need to move away from always looking at innovations as an additional cost, rather than the potential to change the way things are done – to improve productivity, efficiency, and outcomes in the future, such as reduced revisions, reduced length of stay or reducing the need for the patient to come into hospital in the first place.
“This has implications for a better society; it is better for the patient, and better for the environment. However, the funding flow doesn’t recognise this. Sometimes, people know that the innovation can have a massive impact, but they just cannot work out how to get the money to pay for it. We need innovative strategic thinking among finance directors to support this. In the current NHS, where everyone is running to stand still, it is hard for people to find the headroom to drive this forward and get the technology adopted.”
Focus on prevention
In the past decade, there has been a lot of discussion around prevention and early diagnosis, and the use of technologies for ‘out of hospital care’. So, has the moment finally come, post-pandemic?
“We are certainly seeing more of this. It hasn’t taken off yet, but we may be reaching a tipping point,” says Davies. “Previously, it was all about novel medicines coming though. One of the big-ticket items that the NHS is talking about is large-scale diagnostics for detecting early cancer. The fact that money is being spent on this, suggests a slight shift in priorities. It is early days, but it is promising. “
To support the focus on diagnostics and prevention, the ABHI is calling on the Government to increase its per capita spend on diagnosis, compared to other European nations, and to guarantee equity of access to tests – including scans – across all regions of the UK.
“We have an opportunity to fundamentally change the way health and care are delivered if we have a shift towards prevention and remote management outside of the hospital,” Davies argues. “It is necessary, but it is also the right thing to do. However, in the short term, we have a backlog that needs to be addressed – it is going to take some time. We need to think about how we can do this. At the moment, we are making scant headway.”
He points out that we need to be more ambitious than simply returning to ‘preCOVID levels’ – even before COVID we had a large backlog.
“Technology is going to have a huge role to play, whether it is digital technologies or genomics, or precision medicines. COVID saw people’s attitudes towards prevention change and all of this builds on a wider societal shift towards being fit and well. COVID has made people more aware of the need to take care of themselves,” he continues.
The NHS’s ambition to provide more efficient and more integrated care will largely depend on improved connectivity and interconnected healthcare technologies – driving data into the electronic health record will be key.
“We are not gold standard, by any means, in terms of our use of electronic patient records and interoperability with HealthTech. However, progress is being made,” Davies comments. “It is not too bad in primary care, but secondary care is more fragmented and the interface between primary and secondary care needs more work
“Nevertheless, it is now a well-recognised issue, and the Digital Health and Care Plan recently highlighted this. Two billion pounds have been allocated to tackle the problem and a large amount of this is likely to be spent on sorting out the electronic health record. It is the fundamental building block for the digital ecosystem. If we don’t tackle this, it is never going to work. We still have a long way to go – other countries are better integrated and further ahead than we are. We have the potential with our data and our structures; we just need to get the technicalities right.”
The HeathTech sector has also seen significant changes in attitudes to sustainability. Brown points out that, in the past 20 years, the public’s perception of what sustainability is has changed completely – people are far more informed, and this is shaping the HealthTech landscape. In fact, it has become such an important issue, that the ABHI has appointed a fulltime sustainability lead to support this agenda
“The NHS in England has set out its Net Zero ambition for 2045. Suppliers of MedTech must respond for the NHS to deal with this,” Trickett explains. “The NHS has made it clear that it will be building this into its procurement strategy. If a supplier is not compliant with what is set out in the Road Map, the NHS will not be buying from them.
“Therefore, the industry must make some significant changes. ABHI’s board members have funded a collaboration with ARUP consultancy to develop a sustainability guidance framework to help members to be ready for this. Large companies may have had corporate sustainability programmes in place, for a number of years, because it has been important to their investors, while some SMEs will need help navigating this. We are taking this very seriously. But it isn’t easy.”
She points out that there is a lot of single use plastic in the health system but, in many instances, there may be good reasons for this. In addition, sometimes the carbon footprint of a single use product is not worse than the reusable alternative
“We need to carefully assess this, but we also need to ensure that people are doing what they say they are – as no one is policing them. It is easy for suppliers in some other regions to tick all the boxes for the NHS tender, and say they are doing all the right things, but who is going to check? The cost price may be very attractive, and the NHS may choose their product over one which has been manufactured responsibly – where the materials have been sourced responsibly, and the supply chain has considered the carbon footprint.
“It is a big topic, but I see this as our next ‘Brexit’. It is as significant and reaches into the supply chain globally; it will require global change for us to deliver on this. But everyone is taking this very seriously,” she continues.
“There has been a lot of waste generated from our COVID testing requirements. Even during this short time, you could see how the plastic kits got smaller and smaller and the plastic swabs became shorter. Everyone was trying to find ways to reduce the plastic. Industry is responding to the concern
“But technology also has an important contribution to reducing our carbon footprint in healthcare in other ways – we have remote management technologies; pacemakers can be managed remotely for example, so that the patient doesn’t have to come into hospital for unnecessary checks. This is also true of other technologies. Clinicians can make changes to the patients’ devices remotely.
“There are also technologies available to support self-care – eliminating the need for healthcare staff to come to the patient’s home. At any time, 4% of people in hospital are having IV antibiotics. They may be sat in a hospital bed for two weeks. There are technologies that allow this to be delivered via a device in the home. These technologies have a role to play in sustainability and the way in which we treat patients.”
Other key issues include human rights and security within global supply chains. These are extremely complex areas for discussion and ABHI is working to address these areas, in relation to the HealthTech sector. During the pandemic, supply chain issues came under particular scrutiny
“There were localisation behaviours during the COVID pandemic affecting the supply of some products. What we need is recognition from countries that healthcare is a human right and there needs to be fair allocation – not protectionism,” says Trickett.
“Some countries, including the UK, were better than others at not being protectionist. There was a lot of talk, following the pandemic, of ‘onshoring of manufacturing’. But it isn’t possible to onshore everything. Even if you can onshore the final manufacture, you cannot onshore the manufacture of all of the components and materials. We need to think about this from a procurement perspective. If you buy big, and only buy once, at low cost, you only have one supplier. This gives you less flexibility.
“For some products, we have relied on the Far East. We know that NHS supply chain is now keenly looking at their supply chain mapping. But the bottom line is that there are some countries where the expertise sits – that is really difficult to manage. If you are to address this, it requires Governments to make investment decisions. The fact is that manufacture in the UK is more expensive than in China. Is the NHS willing to pay for that? In tough times, the answer is usually no…” She points out that, although there has been a lot of talk of ‘how we can change things’, even production lines of domestic PPE are now having to shut down in some parts of the UK, as people are reverting to buying from sources in the Far East – because it is cheaper.
So, what will be the important trends for the future and how will HealthTech evolve over the next ten years? Trickett points out that HealthTech will continue to advance minimally invasive surgical techniques, bringing increased benefits for patients and healthcare providers alike – such as faster recovery, shorter bed stays, less pain and reduced risk of infection.
“20 years ago, laparoscopic surgery was new; now it is routine. Surgeons now think laparoscopic first and only move to open surgery when the complexity is a deciding factor. In the next 10 years, we can expect much more in the way of minimally invasive techniques and technologies to support this. We are just scratching the surface of robotassisted surgery. The robots are going to become even smarter, and we are going to do much more remotely,” she predicts.
Evans predicts that we will see a convergence of traditional medical devices, diagnostics, and internet technologies. “These technologies used to be siloed, but this trend for convergence is set to accelerate – as an example, this may include a smart inhaler that alerts you when you are entering a high pollen area.”
Brown says that patients will demand more as their knowledge and awareness increases with access to online information and digital resources.
“This will put pressure on manufacturers to think more about this – we will become more patient-driven in how we approach things,” he comments.
For Davies, the explosion of data offers huge potential. “It will all happen in the Metaverse,” he concludes.
Andrew is responsible for working with partners to ensure that the UK maximises the opportunities for citizen health and economic wealth by appropriate investment in data driven healthcare. A vital element of this is building on the unique opportunities delivered by the NHS to enable industry to access robust, well-curated data within a strong ethical framework. Coupled with close engagement with national bodies to evolve regulatory and reimbursement systems, the aim is to create a strong infrastructure and commercial environment that can support the development and widespread adoption of the best HealthTech solutions. He has over 25 years’ experience, having worked within MedTech divisions of household names such as Thorn EMI, Philips and Bristol-Myers Squibb.
Luella joined ABHI in 2019, with over 25 years’ experience in the pharmaceutical and HealthTech industries. Her career has seen her hold numerous specialist manufacturing and commercial roles at Baxter Healthcare, with responsibility for a range of product portfolios across the HealthTech spectrum within the UK, Europe, Middle East and Africa. In 2012, Luella was seconded to the Department of Health for nine months as the Industry Liaison for the NHS Procurement Review, a role which saw her engage with government and the wider Life Sciences sector to facilitate the sharing of ideas and best practice. From 2015, Luella led Baxter Healthcare’s Government Affairs and Public Policy agenda, where she was tasked with managing key policies impacting the HealthTech sector.
Phil started his career at Smith and Nephew qualifying as a Graduate of the Royal Society of Chemistry in 1984, before joining the Company’s Woundcare Regulatory Affairs team at the time when the Medical Device Directive was being enacted. Company moves to Genzyme Biosurgery, Quintiles, Wright Medical Technology and more latterly Kinetic Concepts Inc., (an Acelity company), included work with novel technologies, liaising with National Authorities, the European Commission, Trade Associations and standards bodies on issues related to regulation and ethics. Phil extended his Trade Association work by joining the ABHI in June 2016 as the director responsible for regulatory and compliance matters. Phil is a Fellow of TOPRA and lectures at the Sheffield Hallam University on medical device regulatory frameworks. He also chairs the UK BSI’s CH/210 working group.
Jonathan is responsible for setting and implementing ABHI’s communications strategy. As the public face of ABHI, it is critical that the communications function effectively relays the Association’s key priorities to members, the NHS, government and wider stakeholders, both nationally and internationally.
A member of MedTech Europe’s Communications Committee, Jonathan is also part of the Medical Technology Group’s management committee. A graduate of Cardiff University’s School of Journalism, in his previous role Jonathan led the communications department of Ataxia UK, the national charity for people affected by the neurological condition, ataxia. Prior to this, Jonathan worked in PR.
Jonathan was part of the BBC’s 2010 ‘Blast’ cohort, a national training scheme for budding communications professionals coordinated by the BBC.