Written evidence submitted by Association of British HealthTech Industries (DEL0119)
About ABHI and Reason for Submitting
- The Association of British HealthTech Industries (ABHI) is the leading health technology industry association in the UK. We are a community of over 280 members, from small UK businesses to large multi-national companies. We champion the use of safe and effective medical devices, diagnostics and digital health technologies. The work of our members improves the health of the nation and the efficiency of the NHS.
- The health technology (HealthTech) industry makes a vital contribution to economic growth in our country. The industry employs over 127,400 people across 3,860 companies, mostly small and medium sized enterprises (SMEs). Many companies are working closely with universities and research institutions. The industry is generating a turnover of over £24 billion and has achieved employment growth of greater than 5% in recent years. ABHI’s members account for approximately 80% of the value of the sector as measured by sales to the NHS. As the most highly regarded universal healthcare system in the world, the NHS in turn is dependent on technology produced by the industry to enhance the efficiency of services and drive continuous improvement in their delivery. The NHS has grown and developed partly on the basis of the UK’s historic ‘can do’ approach to engineering and problem solving.
- HealthTech is accordingly an engineering-based industry, characterised by rapid, often iterative product design and development, and a large number of SMEs. It is one of two distinct subsectors of the broader Life Sciences. Future growth and success will mean the HealthTech sector being recognised in its own right. The sector has evidence, regulatory and adoption needs that differ significantly from those of the other, biopharmaceuticals.
- During the pandemic, ABHI and its members have worked closely with officials in NHSE/I and DHSC to minimise supply chain disruptions for critical products and played an active role in initiatives such as the ventilator challenge, testing programme and increased capacity to supply personal protective equipment. In recent weeks we have also started to work on the restoration of routine NHS services from a supply of products perspective.
- The UK will not be alone in restarting routine activity, health systems across the world will be going through the same thought processes about how to safely ramp up elective procedures and which specialties can be started and when. There will likely be a corresponding increase in the demand in for certain categories of products, such as prosthetic knees and hips and optical lenses, associated theatre consumables, anaesthetics, analgesics and surgical instruments. The latter is likely to be a particular concern as the majority of the world’s instruments are produced in Pakistan, which, at the time of writing, is only just beginning to consider easing lockdown restrictions. The UK will need a robust plan to ensure product shortages are avoided, recognising that there will be increased global demand. The situation is likely to impact on any contingency planning for EU exit in December. It will be very difficult to undertake a similar stock building exercise to that undertaken previously, as we anticipate that ordering patterns throughout the world are likely to take some time to return to normal.
- The range of products that will needed to be considered for planning purposes will be significant and will involve a variety of global supply chains, distribution arrangements and procurement routes. It will need to be considerably more wide ranging than previous contingency planning exercises. Another consideration is that many organisations manufacturing products used in the delivery of planned care have scaled back operations during the pandemic, whilst others, who have been able, have transferred their activity to make other products. It will take time for manufacturing volumes to return to pre-crisis levels.
- Planning for the restart of routine activity will almost certainly need to be conducted by the NHS at a local/regional level. However, to ensure equitable distribution of products likely to be in short supply, national oversight will be vital to assess and aggregate demand and determine where such products are allocated. During the early phase of COVID, many ABHI members reported being placed in the untenable position of being chased by as many as 100 individual organisations for equipment that simply did not exist. Companies should not, and cannot, make decisions on which areas of the country are in the most need.
- The crisis has highlighted the critical role industry plays in the delivery of many treatments, through the supply of equipment, providing resource to support interventions and the service and maintenance of equipment. What has also become clear is that a number of elements are required to ensure that the NHS receives the HealthTech products its needs, not just during the crisis, but as routine activity is restored. Firstly, national oversight of product demand, utilising lessons learnt from COVID planning and shared with suppliers at the earliest opportunity. There will be product areas that are required in both COVID and routine work (PPE, Anaesthetics etc) and clear prioritisation will be required. There should be an integrated planning process, with supplier involvement, and visibility of key data between industry and the NHS to ensure the necessary support and supplies are available. Industry must be able to forecast and schedule manufacturing and work across the supply chain to inform the NHS on lead times for critical items.
- The ability to restart routine activity will vary depending on local circumstances and to what extent services have already been reconfigured as part of the crisis response. Treating patients in the “shielded” population will require particular thought and planning. A number of high volume, low risk procedures such as joint replacements and cataracts, which might instinctively seem ones which should be restarted quickly, are also those where the age profile of patients will be that of the shielded population. A response to this might be to expand the capacity of clean, cold elective centres. These would be COVID free hospitals carrying out routine, low risk procedures. The availability of testing will clearly be important in protecting the integrity of such centres. Screening protocols will need to reflect local circumstances and the cohort pf patients being treated.
- Technologies that facilitate the treatment of patients remote from traditional healthcare settings have been available for some time, but their benefits have never been fully realised. The scope of these technologies is wide, and it is an area that is burgeoning with rapid advancements in digital healthcare. From allowing remote consultations to monitoring vital signs, such technologies can reduce unnecessary contacts, something that will be important if social distancing needs to be continued for some time to come. Many outpatient appointments are now being conducted remotely, and we understand that this is something that is working well and is sustainable for many, even the majority of patients. A fundamental change in the delivery of outpatient services has enormous potential to free up space and human resource in the NHS. It has been widely recognised that during crisis, the NHS has embraced the use of technologies and new ways of working at a pace and scale it has often not been able to manage in normal times. It is important that this momentum is not lost in the restoration and recovery phase the NHS will hopefully shortly enter.
- Amongst a number of important elements necessary to maximise the potential of digital solutions, ABHI would like to highlight two, public confidence in the use of data and the interoperability of platforms and tools. In our Manifesto ahead of the last General Election, we suggested that there should be a public awareness campaign to highlight the positive aspects of data sharing. Not least are the immediate benefits to an individual inputting data to inform an algorithm that will guide their own treatment. The potential of initiatives such as “test, track and trace,” are now well rehearsed in the public domain, and this presents an opportunity for a national debate. As more and more digital applications become available, it will be important to ensure a degree of interoperability between different platforms and allow patients to blend a number of technologies to best suit their own needs.
- Underpinning the introduction of new technologies, is the need for a flexible and enabling regulator for the sector. The Medicine and Healthcare Products Regulatory Agency has long been regarded as one of the pre-eminent regulators in the world and, in its response to the ventilator challenge, new tests and PPE, has demonstrated admirable flexibility and pragmatism. This will be even more important as we seek to ensure patient safety in a new, digital age. Pharmaceutical products tend to iterate over a period of 10-12 years, whilst for traditional medical devices this period is 12-18 months, which itself presents challenges for regulators. Digital technologies, based on AI and deep learning, may iterate instantaneously with each piece of information that is entered into an algorithm. As the largest single payer healthcare system in the world, the NHS has the ability to lead the way in the use of these technologies, not just for the benefit of its own patients and staff, but to turn the UK into a global leader in the development and export of digital health. This will require a new approach to regulation, including an empowered and adequately resourced regulator.
- It should be noted that national screening programmes have been suspended during the lockdown period. This is potentially storing up a backlog of patients who will require interventions more urgently than might have otherwise been the case. Uptake in some of these programmes has always been sub optimal, will likely be affected by the pandemic and consideration will need to be given to how to ensure the public has the confidence to access healthcare facilities.