Medical know-how technique


The position of medical know-how in bettering well being outcomes

Medical know-how, or ‘medtech’, is of important significance to the UK well being and care system. It consists of objects we depend on every single day, from a easy plaster for a scraped knee, to life-saving blood assessments that detect most cancers early and robots that may carry out extremely complicated surgical procedures. Medtech merchandise could be present in hospitals, ambulances, docs’ surgical procedures and even our personal houses and play an important position in the entire pathway of care, supporting folks from prevention, via to prognosis, remedy and ongoing administration of well being. Though medtech merchandise are available many shapes and types, all of them have one factor in frequent – they’re designed to assist us perceive and enhance folks’s well being.

This doc presents the inaugural UK medtech technique and the timing couldn’t be higher. The COVID-19 pandemic highlighted the very important significance of medtech, with ventilators and lateral stream assessments enjoying an indispensable position in our pandemic response. We should take the learnings from these experiences and use them to construct a stronger future. Efficient use of medtech can be important in transferring forwards from the pandemic, supporting the elective restoration plan by lowering diagnostic bottlenecks and ready lists, and by delivering new and improved methods to deal with and assist sufferers.

Medtech can cut back well being disparities by bettering the evaluation of well being dangers and assist us to raised handle long-term situations, supporting folks to stay longer, more healthy, extra impartial lives. Improvements in medtech may even assist the NHS in delivering its internet zero ambition in a wide range of methods, from utilizing supplies extra effectively to the introduction of extra sustainable fashions of care. As a big space of spend, medtech additionally has an necessary position to play within the long-term monetary sustainability of the UK well being and care system.

Medtech is a vitally necessary trade for the UK financial system, representing over half of all life sciences employment, with companies located throughout the UK and contributing billions of kilos to the financial system. As a rustic we’re identified for world-leading scientific analysis and growth capabilities, and the UK well being and care system is globally recognised as a profitable and trusted well being system, making the UK a serious participant on the worldwide healthcare stage. We should encourage bold, modern analysis and switch innovation into actual advantages for society, serving to safe the place of the UK as a world science superpower. Transferring forwards, we’ve got the chance to make the UK an much more engaging marketplace for companies by bettering entry, shaping our personal regulatory framework, main in analysis and growth, and sustaining a powerful worldwide market presence.

As we set out on this journey, I wish to prolong my because of our colleagues throughout the well being and care system, the medtech trade and devolved administrations for his or her invaluable enter. We’ve been exceptionally lucky throughout the growth of this technique to have the ability to interact and collaborate with a variety of individuals and organisations to assist us construct a broad and balanced image of how we are able to drive the sector forwards, and I’m assured this technique, and the continued collaborative effort behind it, will ship tangible advantages throughout the UK as a complete for sufferers and care suppliers in addition to the UK medtech trade and people working within the sector.

Will Quince

Minister of State (Minister for Well being and Secondary Care)


Medical know-how (medtech) is significant to serving to folks stay extra impartial, more healthy lives for longer. As an integral a part of our well being and care system, it has an important position in our potential to ship the most effective look after sufferers.

The UK well being and care system is at present dealing with a sustained improve in strain pushed by rising healthcare wants. The demographics of the nation are altering – the inhabitants is changing into older, individuals are dwelling with extra co-morbidities, and have increased expectations of the well being and care system. These monetary and supply pressures have been additional exacerbated by the COVID-19 pandemic.

Our strategy to medtech coverage should due to this fact go hand-in-hand with the numerous transformation taking place throughout the UK well being and care system and should complement and strengthen it. Regardless of the significance of medtech to the well being and care system, there has to not date been a central governmental strategy. Transferring forwards, we should co-ordinate and align motion throughout all our system companions, and drive enchancment in precedence areas to ship efficient and significant change that advantages sufferers.

Intention of the technique

This doc outlines how we’ll make sure the well being and social care system can reliably entry protected, efficient and modern medical applied sciences that assist the continued supply of high-quality care, excellent affected person security and glorious affected person outcomes in a manner that makes the most effective use of taxpayer cash.

The medtech sector is complicated, broad and various with a number of individuals and stakeholders. We’ll carry readability to this complicated panorama by focussing on a transparent imaginative and prescient, centred on a very powerful points. This can set the route of journey for medtech throughout the UK well being and care system.

Constructing on the broader Life Sciences Imaginative and prescient, this high-level doc evaluations the present UK medtech panorama and identifies and prioritises the areas for motion. This technique will type the idea of future implementation plans that may set out intimately how these priorities can be addressed, and the way these actions will construct in the direction of reaching the imaginative and prescient for medtech. In some areas present analysis and areas of greatest follow will present frameworks from which these implementation plans could be constructed, however it’s recognised that in some areas there’ll must be further work to find out the actions to take.

We recognise that any transformation of the medtech market is a long-term problem and can must be delivered incrementally via collaboration between the well being system, sufferers, and medical, educational and trade companions.

Definition of medical know-how

A medical gadget is any instrument, equipment, equipment, software program, materials or different article, whether or not used alone or together, along with any equipment, together with the software program meant by its producer for use particularly for prognosis or therapeutic functions or each and obligatory for its correct software, which is meant by the producer for use for human beings for the aim of:

prognosis, prevention, monitoring, remedy or alleviation of illness

prognosis, monitoring, remedy, alleviation of or compensation for an harm or handicap

investigation, substitute or modification of the anatomy or of a physiological course of

management of conception

A medical gadget doesn’t obtain its essential meant motion by pharmacological, immunological or metabolic means though it may be assisted by these – Medical Units Laws 2002 (SI 2002 No 618, as amended) ( UK MDR 2002). Medical units could be:

common medical units – reminiscent of syringes, dressings, coronary heart valves, ECG displays, CT scanners and dialysis machines, together with any software program used to drive them

displays, scanners and dialysis machines, together with any software program used to drive them energetic implantable medical units ( AIMDs ) – powered implants or partial implants which can be left within the human physique, reminiscent of implantable cardiac pacemakers, implantable nerve stimulators, cochlear implants and implantable energetic monitoring units

) – powered implants or partial implants which can be left within the human physique, reminiscent of implantable cardiac pacemakers, implantable nerve stimulators, cochlear implants and implantable energetic monitoring units in vitro diagnostic medical units ( IVDs ) – tools or programs meant to be used in vitro to look at specimens together with all devices, software program, reagents and calibrators, reminiscent of blood grouping reagents, being pregnant check kits and hepatitis B check kits

) – tools or programs meant to be used in vitro to look at specimens together with all devices, software program, reagents and calibrators, reminiscent of blood grouping reagents, being pregnant check kits and hepatitis B check kits digital well being and software program – reminiscent of standalone software program, choice assist and cell apps

Medical know-how is an evolving area, with scientific and engineering breakthroughs prompting new improvements and altering societal wants upsetting artistic approaches. On this technique we’ll concentrate on common medical units, AIMDs , IVDs , and the digital instruments that drive them instantly. This can embody their related makes use of and markets and offering assist in areas of overlap between bodily units and digital instruments.

Imaginative and prescient for medtech

Our imaginative and prescient focusses on 3 central targets:

proper product

proper worth

proper place

These ideas centre on delivering the best high quality of look after sufferers and work together with and steadiness in opposition to one another – usually, as concentrate on one part will increase, concentrate on the others can lower. Putting the very best steadiness between these targets is tough, however we’ll purpose to succeed in an optimum level the place all 3 components are weighted appropriately so the UK medtech sector greatest helps the UK well being and care system in delivering improved well being outcomes for sufferers (see determine 1).

Determine 1: the three core elements of the medtech imaginative and prescient

Determine 1 exhibits the three core elements of the medtech imaginative and prescient introduced as a Venn diagram. There are 3 circles:

proper product, which have to be protected for all, clinically efficient, modern and sustainable

proper worth, which have to be worth for cash, outcomes-focussed, entire pathway price and high quality information

proper place, which should embody entry, availability, adoptions and resilience

The realm connecting these circles represents a spot of optimum steadiness between the targets.

Proper product

We’ll guarantee merchandise are clinically protected and efficient for all by growing best-in-class laws and upholding security requirements. We’ll encourage modern and sustainable product growth to raised meet affected person wants, prognosis and outcomes.

The UK has a various inhabitants, and it’s vitally necessary that each particular person has well timed entry to efficient, protected, medical know-how no matter ethnicity, intercourse or some other attribute. We need to put medical management on the forefront of medtech, ensuring healthcare professionals and sufferers could make knowledgeable selections on medtech merchandise with readability and confidence. We need to assist innovation that meets the wants of the UK inhabitants, reminiscent of by addressing medical priorities and growing sustainability.

Proper worth

We’ll create an atmosphere that helps the understanding and supply of worth for cash and affordability throughout the entire affected person pathway, utilizing high-quality information to make sure that costs are cheap for each the well being system and sustainable for suppliers.

To make sure the most effective worth for public cash, the worth of medtech merchandise shouldn’t be thought-about in isolation however throughout the entire affected person pathway. Affordability, long-term worth and above all affected person outcomes should type a part of this evaluation, in addition to an acknowledgement that ‘lowest worth’ doesn’t all the time translate to ‘greatest worth’. Guaranteeing we’ve got clear, dependable information to underpin our selections will assist us to attain this.

The significance of getting the fitting merchandise on the proper worth can be much more necessary as we tackle the pressures on affordability introduced by elements reminiscent of altering demographics and inflation.

Proper place

We’ll make sure the UK is positioned internationally and domestically to extend entry, range and resilience within the provide market, to get know-how to the sufferers and healthcare skilled who want them.

Confidence within the availability of medtech merchandise on the time they’re wanted is important to the functioning of the well being and care system. Entry to the fitting merchandise, supply of them by way of a responsive and resilient provide chain and supporting their adoption into the UK well being and care system ensures everybody has entry to medical know-how as and after they want it.

The medtech panorama

UK medtech key information and figures

The UK has a big and numerous medical know-how trade, with a broad footprint throughout the UK. Medtech merchandise are utilized by tens of millions of sufferers every single day and are important to our well being and social care system. The medtech panorama is exclusive and complicated in lots of elements.

Medtech is an important UK trade

Whole present healthcare expenditure within the UK accounted for 12.0% of gross home product (GDP) in 2020, in contrast with 9.9% in 2019. Of this, spend on medtech makes up a big quantity – the NHS alone spends an estimated £10 billion a yr on medtech ( DHSC Estimate, 2021, based mostly on a number of information sources). The medtech sector is a vital supplier of alternatives for jobs and growth of specialist abilities in native areas throughout the UK.

For each the core medtech and repair and provide chain sectors, the South East, London and the East of England account for 41% of the employment, and 59% is positioned exterior of those areas, with important UK-wide regional clusters. A big quantity of medtech employment within the UK, round 31%, is in small and medium-sized enterprises ( SMEs ), which make up over 85% of the businesses within the UK medtech sector.

The UK can also be a serious participant within the worldwide market, exporting over £5.6 billion of medtech merchandise in 2021.

Determine 2: UK medtech trade key figures

Determine 2 illustrates the UK medtech trade figures. The UK medtech trade has an annual turnover of £27.6 billion. This consists of:

138,100 UK jobs

over £5 billion in exports yearly

31% of life sciences turnover

over 85% SMEs

4,190 UK companies

Sources: Bioscience and well being know-how sector statistics 2020, MedTech Europe’s information and figures 2021 and DHSC estimates 2021 based mostly on a number of information sources.

The industrial panorama is broad and extremely various

There are slightly below 2 million merchandise registered to be used on the UK market (Medicines and Healthcare merchandise Regulatory Company ( MHRA ) figures April 2022). Presently, round a 3rd of spend within the NHS (an estimated 33%) is on implants and prostheses, and surgical tools, which account for 17% and 16%, respectively, of annual spend within the UK on medtech ( DHSC inner evaluation) (see determine 3).

Determine 3: the highest 10 medtech product sorts by spend, 2021

Determine 3 illustrates the highest 10 medtech product classes by spend ( DHSC inner evaluation, December 2021). The determine is titled ‘relative NHS spend by medtech product kind’ and exhibits a hoop divided into 11 segments demonstrating the share of spend on medtech product sorts. These are:

implants and prosthesis 17percentsurgical tools 16%

laboratory tools 11%

sterile process packs 11%

IV tools 9%

tools 9% cardiovascular 7%

anaesthetic 5%

dressings 4%

radiology 3%

affected person monitoring 3%

different 13%

Sources: MHRA figures, April 2022 and DHSC inner evaluation, NHS buying for 12 months to December 2021. Early evaluation based mostly on NHS buy order information, categorised by eClass class, and additional grouped into customized medtech classes. Authentic information on file.

The availability chains for medical know-how merchandise are numerous

Provide chains usually contain a number of levels and may span throughout a number of nations, counting on in depth use of outsourcing for supplies, elements, meeting and supporting providers (reminiscent of sterilisation and logistics). Many medtech merchandise are comprised of a number of sub-components and uncommon supplies, and these additional add to the complexity of the availability chain. In 2021, the UK imported round £7.5 billion of medtech merchandise, excluding supplies and subcomponents.

Medtech is a high-paced space of innovation

In 2021, the UK made 471 medical know-how patent functions – 1 in 12 of all UK patents – to the European Patent Workplace. This concentrate on novel know-how is supported by a broad vary of funding and assist schemes. The need to stimulate and assist innovation has resulted in a variety of initiatives being arrange on this house. In 2021, there have been round 60 completely different programmes supporting modern applied sciences, representing over £1 billion of funding (estimates based mostly on NHS Accelerated Entry Collaborative information and DHSC inner evaluation, Could 2022).

Regardless of the a number of pathways and important funding, the innovation frameworks could be tough to navigate, with the bulk supporting solely one of many many steps within the path to market – it’s as much as the innovator to analysis and hyperlink completely different programmes.

The event of the technique

We’ve taken a multi-faceted strategy to technique growth to take into consideration the at present out there proof, the views and desires of our stakeholders, and the broader priorities of the federal government. In growing the technique, it has been a precedence for us to grasp and align with these very important factors. This technique seeks to assist the present work throughout the broader well being and care panorama and to keep away from duplicating any present actions the place these are already proving to be efficient. As a substitute, we want to concentrate on areas the place there are gaps and important alternatives for enhancements.

Collectively these approaches have given us a broad understanding of the sector from many alternative viewpoints and have allowed us to take these into consideration to construct an bold however achievable imaginative and prescient and technique.

Extra data on the event of the technique is accessible in Annex A: strategy to technique growth.

Participating with our stakeholders

By means of in depth engagement with stakeholders throughout the UK well being and social care system we’ve got recognized the coverage priorities which can improve UK strengths, probably the most urgent challenges we face, and the place we are able to result in probably the most important change for the UK medtech sector.

Trade, the well being and care system, and sufferers

Dialogue between authorities, trade, the medical and industrial healthcare neighborhood and affected person teams has proven a really constant image – the medtech sector at present has many strengths, and it’s our ambition to keep up and assist these whereas responding to the challenges we face. We’ve mixed stakeholder suggestions with an summary of initiatives throughout authorities and our supply companions to establish the coverage priorities we want to concentrate on on this technique.

Alignment throughout governments

Many elements of well being coverage and operational administration are devolved and due to this fact it’s for the devolved administrations to find out priorities and approaches for addressing these. Nevertheless, some areas of well being coverage are reserved. Consequently, it’s broadly recognised that actions and initiatives in a single nation are more likely to impact different components of the UK. That is notably true in England as a consequence of its bigger inhabitants, which in flip drives a a lot increased demand for medtech services.

In view of this, whereas the technique units out priorities and actions that can be taken ahead in England, we’re eager to make sure that the implications that this work could have for the opposite components of the UK are recognised, and that we proceed to work collaboratively throughout the nations in order that the UK as a complete can profit from the improved outcomes. This precept of continued engagement and collaboration additionally applies to particular initiatives inside the devolved administrations within the pursuits of sharing studying and drawing on the breadth of experience and expertise current from throughout the UK for the advantage of all.

In step with this, the technique has been developed via collaboration throughout the UK with trade, our supply companions and the devolved administrations. Though there are completely different organisations and approaches throughout Scotland, Wales, Northern Eire and England, there are various areas of synergy, and powerful consensus on the worth of medtech and the necessity for an elevated concentrate on this space.

We’ll proceed to work intently with the devolved administrations, the NHS in Scotland and Wales, Well being and Social Care Northern Eire, and all different well being and care organisations throughout the UK to facilitate supply of our imaginative and prescient in all components of the UK, with the purpose of bettering affected person outcomes for all.

Aligning with broader strategic goals

Wider authorities priorities

The significance of the medtech sector means lots of the top-level priorities of the federal government affect the sector, and in flip the sector can have important affect on these priorities. These priorities are mirrored in lots of authorities insurance policies and methods, together with however not restricted to:

The ambitions of the medtech technique have been designed to align with wider authorities priorities reminiscent of:

rising the UK financial system by supporting a vibrant medtech trade, serving to safe the place of the UK as a world science superpower

clearing the backlog of elective care by serving to to scale back strain on the NHS, utilizing fewer assets and delivering higher outcomes via informing efficient healthcare buying, championing sustainability, embracing modern know-how and bettering well being information

capitalising on post-EU exit alternatives by constructing our personal regulatory regime for medical units to enhance affected person security, improve transparency and promote innovation

levelling up by creating an atmosphere for the medtech trade to thrive, growing alternatives for careers that develop specialists in native areas throughout the UK

boosting analysis and growth and supporting innovation and adoption by encouraging bold modern analysis and supporting the processes to show modern concepts into tangible advantages for sufferers and healthcare professionals

strengthening the union by working collectively to share information and greatest follow to ship profit for the UK as a complete

For additional element on alignment with wider authorities technique, see Annex B: areas for shared engagement.

Constructing on supporting infrastructure

UK analysis and growth helps all the medtech product lifecycle, from early growth via to implementation, and this sustains and stimulates the pipeline of medtech merchandise, driving innovation whereas producing the proof required for adoption. UK analysis and growth funding, via funders such because the Nationwide Institute for Well being and Care Analysis ( NIHR ) and UK Analysis and Innovation ( UKRI ), represents an space of power the place a number of authorities initiatives and methods mix to ship a wider purpose.

The constructions in place have clear goals and powerful relationships with all components of the well being and care system. For instance, the NIHR analysis infrastructure, which facilitates early translational, medical and utilized well being analysis, brings collectively main teachers, clinicians and NHS suppliers to work with medtech innovators, to assist them generate the proof wanted by MHRA and NICE . This underlying analysis and growth system, coupled with sources of analysis and growth funding, make the UK a sexy place for each trade and academia to base their analysis, offering experience to ship analysis research and linkages to assist pull-through to the UK well being and care system. The UK analysis and growth atmosphere represents an space the place a number of companions work successfully collectively to ship a constant and complete panorama. As such, the technique doesn’t search to essentially change these present constructions, however reasonably to work with and construct upon them, as it’s recognised that they’re very important enablers in delivering the imaginative and prescient for medtech.

The assist of key enablers within the UK panorama supplies an atmosphere for medtech to thrive. Within the Medicines and Healthcare merchandise Regulatory Company ( MHRA ) and the Nationwide Institute for Well being and Care Excellence ( NICE ) we’ve got internationally revered regulatory and steering our bodies with world-class requirements and a powerful affected person focus. The path to market could be comparatively quick. Regulatory programs have proven their potential to reply with agility to world incidents – for instance, 22 important merchandise got distinctive use authorisation in a fast response to the COVID-19 pandemic. Work is already underway to maximise alternatives within the present panorama, reminiscent of new regulatory powers post-EU exit. The regulatory house has clear possession with work nicely underway to maximise alternatives within the present panorama. Nevertheless, we do recognise that regulation is a elementary a part of realising our ambitions, so we’ll work intently with our regulators to make sure that our priorities are supported by the suitable laws and steering.

We’ll proceed to work with system stakeholders to ship this bold imaginative and prescient, together with the NHS Transformation Digital Coverage Unit, on the areas of overlap between bodily units and digital instruments to implement this technique and information the event of future NHSE digital methods.

Supporting present sector initiatives

In addition to the numerous positives within the sector, there are some areas that might be additional strengthened. A number of of those areas have already been recognized and are the main focus of present initiatives which can be already nicely developed and resourced and are nicely aligned with our imaginative and prescient. These vary from sustainability initiatives to routes to market, from information programmes to frameworks to enhance affected person security. To call only some, some necessary examples embody:

the work in the direction of the brand new UK Medical Units Regulatory Framework

the NHS Core20PLUS5 strategy to tackling well being disparities at each nationwide and system ranges

progress to fulfill the NHS internet zero ambition

the work throughout the Accelerated Entry Collaborative ( AAC ) for ground-breaking improvements

) for ground-breaking improvements the actions following the publication of the Impartial Medicines and Medical Units Security Evaluate

These programmes are owned by lots of our supply companions throughout the medtech sector, and have well-developed proof, governance and implementation plans in place.

Sustainability is a vital difficulty, and one which is extremely related to medtech. In England, the NHS carbon footprint contributes as much as 4% of greenhouse gasoline emissions. Over 60% of the whole NHS carbon footprint sits inside the provide chain, with 10% attributed on to medical tools. There’s additionally the problem of single-use plastic, the place initiatives have proven the NHS can tremendously enhance waste and save prices via lowering its consumption, with out compromising affected person care or security (see the Nice Ormond Road Hospital lowering single use plastics case research).

We have to embrace sustainability, meet the NHS internet zero targets by 2045, and promote innovation that may ship clinically protected and efficient merchandise which can be higher for the planet. Sustainability is a broad and necessary space, with a transparent plan and proprietor within the type of Greener NHS. On this technique we’ll focus our concentrate on the place aligning with sustainable initiatives can assist medtech priorities reminiscent of provide resilience.

For extra element on these initiatives and the way they align with the technique, see Annex B: areas for shared engagement.

Our 4 precedence areas

Having thought-about the broader panorama and present exercise, we’ve got recognized the gaps and alternatives the place we want to prioritise further effort. Along with the present work within the sector, the next precedence areas will assist us in delivering the fitting product, for the fitting worth, in the fitting place.

Precedence 1: resilience and continuity of provide

Continuity of provide of medtech is important to the availability of ongoing care to sufferers and so have to be robustly assured. Medtech provide chains are reliant on a number of nations and susceptible to disruptions to world buying and selling agreements and fashions created by world occasions and actions of nation states. The capability of provide chains to reply to shocks is restricted, and when there are shortages, it’s usually tough to supply appropriate alternate options. There’s at present a excessive reliance on stockpiles to make sure continuity of provide. A number of organisations have a duty to make sure provide is powerful and that the availability of medical applied sciences continues within the occasion of rising points. There’s a clear have to set route of journey for the mid and long run in a manner that proactively addresses resilience and pre-emptively plans for and mitigates dangers to produce that exist within the present system.

Precedence 2: modern and dynamic markets

Modern medtech presents an necessary alternative to enhance affected person outcomes and assist ship greatest worth for taxpayer cash. Regardless of this, it’s not all the time clear what the well being and social care system needs and desires, and this may be additional difficult by excessive ranges of unwarranted variation in product use throughout the NHS, and limitations to switching between merchandise. There are lots of initiatives and pathways designed to deal with particular challenges, particularly new and transformative product improvements. The realm would profit from further coherence and co-ordination for brand spanking new and present merchandise within the system to assist guarantee sufferers have entry to the most effective merchandise, sooner.

Precedence 3: enabling infrastructure

In an effort to ship our ambitions within the medtech sector we’d like an underlying framework of enablers that may assist our work. A scarcity of enablers within the sector can restrict the alternatives for constructive change. A scarcity of clear information and metrics could make it obscure each the present scenario and rising tendencies within the sector. Unclear mechanisms for engagement can restrict the collaboration and collective motion achieved throughout authorities, trade and the broader well being and care system. Enhancing these areas will raise limitations to delivering affected person outcomes, and permit us to take clear, well-informed selections throughout the sector.

Precedence 4: particular market focusses

Medtech represents an exceptionally numerous space, so any strategy should recognise the complexity of this sector. Though there are various similarities throughout medtech, many points and challenges are particular to specific sorts of know-how, medical specialties, affected person populations and place of use. Making significant distinction means focussing on, understanding and tackling these particular issues in addition to working in the direction of an general imaginative and prescient. We’ll look to proactively establish these areas and guarantee we adapt our broader technique to greatest meet their particular wants.

The next sections define the important thing challenges in every of the precedence areas, and the way we plan to deal with them.

Determine 4: present exercise and recognized gaps for technique precedence areas that contribute to the medtech imaginative and prescient

Determine 4 units out which wider authorities priorities and chosen sector initiatives contributed to the event of the medtech imaginative and prescient, and the gaps recognized which can be addressed by the 4 precedence areas. The broader authorities priorities are throughout the entire of the UK and embody methods, white papers and studies reminiscent of construct again higher, the Life Sciences Imaginative and prescient, levelling up, UK analysis and growth roadmap, the UK innovation technique and the Cumberlege report.

Chosen sector initiatives are:

sustainability (NHS) – this consists of internet zero, single use plastics and useful resource effectivity

innovation ( NIHR and AAC ) – this consists of analysis funding, entry and horizon scanning

and ) – this consists of analysis funding, entry and horizon scanning analysis ( HRA ) – this consists of transparency, ethnical reviewing and selling affected person pursuits

) – this consists of transparency, ethnical reviewing and selling affected person pursuits regulation ( MHRA ) – this consists of security and UK MDR

) – this consists of security and provide and distribution (NHS Provide Chain) – this consists of procurement, vary administration and logistics

worldwide management ( DIT ) – this consists of exports, progress and inward funding

) – this consists of exports, progress and inward funding procurement (NHS) – this consists of functionality constructing, balanced analysis and competitors

medical high quality ( NICE , Well being Know-how Wales) – this consists of analysis and innovation

, Well being Know-how Wales) – this consists of analysis and innovation digital (NHS Transformation Directorate) – this consists of digitalisation, information, innovation and transformation

Precedence 1: resilience and continuity of provide

Continuity of provide of medical tools, units and consumables is important for the constant supply of protected, high-quality affected person care. The UK medtech sector has functioned nicely via a wide range of industrial and logistical fashions to keep up continuity of provide throughout an in depth vary of merchandise. The number of suppliers, provide channels and merchandise out there has offered a degree of systemic resilience that has largely insulated the well being and social care system from short-term provide disruptions.

Nevertheless, growing consolidation within the sector and globalisation of manufacturing and provide chains has lowered a few of this resilience, uncovered the sector to a broader vary of threats and made it extra susceptible to world occasions and actions of nation states. Current occasions together with the COVID-19 pandemic and the struggle in Ukraine, and the following disruption of worldwide buying and selling and logistics programs has delivered to gentle vulnerabilities inside many important medtech provide chains the place an over-reliance on single places or sources of supplies and supporting providers exists. It’s cheap to count on that extra of those world occasions will occur sooner or later. Current developments within the geopolitical panorama sign the potential for much higher disruption sooner or later. We should due to this fact put programs, plans and methods in place to proactively put together for rising dangers in a manner that may permit us to successfully mitigate impacts as and after they come up, in addition to bettering the general resilience of worldwide provide chains.

A shared duty for provide resilience

It’s recognised that authorities must play a component in securing continuity of provide, particularly within the face of main incidents and occasions. Nevertheless, provide resilience must be on the forefront of concerns for medtech companies’ sourcing, manufacturing and provide chain fashions, notably for probably the most important medical applied sciences.

Strengthening contractual necessities might assist this – nevertheless, we additionally acknowledge the worth that voluntary initiatives can herald establishing greatest follow rules of provide resilience administration extra broadly throughout the sector.

UK medtech versatile manufacturing capability and functionality

The globally prolonged nature of provide chains coupled with restricted UK based mostly manufacturing functionality and capability presents an extra vulnerability to produce. Whereas it’s recognised that not all merchandise can be wholly made within the UK, sustaining the essential capabilities to assist manufacturing of a broad vary of medical applied sciences requires higher focus. Present schemes, such because the Life Sciences Modern Manufacturing Fund, will assist this ambition to assist progress within the UK life sciences sector and to enhance the UK’s potential to reply to main shocks or buying and selling constraints.

Institution of those capabilities and capability additionally has a task to play within the realisation of our ambition to ascertain higher use of commercially viable and resilient round financial system fashions for medical applied sciences the place the supporting infrastructure for reuse, remanufacture and supplies restoration will must be positioned close to to the purpose of use.

Supporting interoperability

The widespread use of apparatus designed solely to work with proprietary consumables (solely out there from a single provider) will increase vulnerability to produce disruption occasions as it’s not potential to make use of different consumable merchandise and changing total programs shortly is commonly impractical given restricted availability of substitute tools, coaching necessities and financing pressures. The affect of this was felt sharply in intensive and important care areas on the peak of the pandemic and positioned undue strain on already overstretched logistics programs via the necessity to carry merchandise throughout duplicated ranges.

Whereas it’s recognised that in some instances designing bespoke consumables to work with tools might help design in security, experiences of the previous couple of years name for a recent have a look at the best way merchandise are designed and the scope to take away pointless inflexibility, particularly the place the availability preparations for these merchandise are insufficiently resilient. The place there are clear security advantages to proprietary fashions there’s a want to ascertain a spread of heightened resilience necessities for the suppliers of those programs that displays the chance to affected person lives and wellbeing introduced within the occasion of a disruption.

Trade has labored successfully prior to now with the well being system and authorities to develop common design specs and requirements which incorporate important security components – for instance, the event of ENFit and related normal ISO80369-3 to forestall probably deadly errors within the connection of enteral feeding tubes.

Useful resource safety and effectivity

The excessive prevalence of single use units equipped into the UK well being and care system created further strain when responding to the fast will increase in affected person demand created by COVID-19. In lots of instances manufacturing and logistics programs had inadequate capability to proceed supplying units in portions required. A few of this strain might have been alleviated if merchandise and provide fashions had been designed to facilitate higher decontamination, reuse or remanufacture of units. The heavy reliance on single use fashions of provide additionally heightens publicity to volatility and vulnerabilities within the provide of uncooked supplies and elements, as highlighted by commerce restrictions ensuing from the battle in Ukraine.

Transferring in the direction of units which can be designed to be decontaminated and reused, or that may be remanufactured, would assist to scale back our reliance on each uncooked materials availability and the capability of manufacturing and logistics. To realize long-term resilience in provide, the medtech trade more and more must design merchandise in a manner that reduces the demand on virgin supplies, makes higher use of recycled supplies and in the end will increase the extent to which the availability of medtech can shift to assist considerably increased ranges of reuse, remanufacture and supplies restoration.

Determine 5: causes and actions for precedence 1: resilience and continuity of provide

Determine 5 units out the trigger, downside, key impacts of precedence 1 and the corresponding actions required. These are:

lowered ranges of sector resilience and lack of constant resilience necessities for trade means there’s excessive reliance on authorities and well being system reserves. This causes a reactive strategy to resilience and inefficiency. To deal with this, we should steadiness the burden of resilience

main manufacturing functionality for consumables largely offshore means there’s restricted medtech manufacturing capability and functionality within the UK. This causes restricted potential to response to shocks and assist progress in UK life sciences. To deal with this, we should improve UK medtech manufacturing functionality and capability

tools is designed to work with proprietary consumables and restricted use of common requirements for important medtech programs means there’s publicity to single factors of failure in provide chains. This causes extremely restrictedability to keep up care provision within the occasion of disruption. To deal with this, we should improve resilience via interoperability

over reliance on single use provide mannequin and lowering entry to low cost supplies, vitality and labour imply publicity to useful resource shortages and worth volatility. This causes improve frequency and severity of disruptions impacting affected person care and security. To deal with this, we should enhance useful resource safety and effectivity

The goals of precedence 1 can be achieved by:

balancing the burden of resilience: we’ll work with NHSE on the event of procurement coverage to advertise the proportionate software of necessities for resilience, alongside an evaluation of the potential for voluntary initiatives and regulatory enhancements that may facilitate a proactive strategy to produce resilience

on the event of procurement coverage to advertise the proportionate software of necessities for resilience, alongside an evaluation of the potential for voluntary initiatives and regulatory enhancements that may facilitate a proactive strategy to produce resilience growing UK medtech manufacturing functionality and capability: we’ll work with trade, OLS , the Division for Enterprise, Vitality and Industrial Technique ( BEIS ) and the UK well being and care system in figuring out the manufacturing functionality and capability that’s wanted within the UK to substantively improve the UK medtech sector’s resilience, and to evaluate synergies with the broader Life Sciences Imaginative and prescient and different authorities goals to establish viable fashions for funding

, the Division for Enterprise, Vitality and Industrial Technique ( ) and the UK well being and care system in figuring out the manufacturing functionality and capability that’s wanted within the UK to substantively improve the UK medtech sector’s resilience, and to evaluate synergies with the broader Life Sciences Imaginative and prescient and different authorities goals to establish viable fashions for funding enhancing resilience via interoperability: we should clearly establish areas of care the place proprietary fashions are unwarranted. So far as potential, the well being system ought to undertake clinically acceptable standardisation specs to assist interoperable programs. The place this isn’t potential, we should always work with trade to ascertain minimal provide resilience requirements for proprietary programs

bettering useful resource safety and effectivity: we should cut back the amount of single use units used within the UK well being and care system via the elevated adoption of multi-use and remanufactured options, whereas sustaining high quality and security of affected person care. We should always cut back the general amount of plastics and the proportion of virgin fossil hydrocarbon-based plastics utilized in medtech merchandise, exploring the scope to make higher use of recycled supplies and biopolymers. We’ll search collaboration with trade and analysis companions to facilitate a shift to elevated useful resource effectivity. We’ll discover how we are able to create an atmosphere that helps commercially viable fashions that improve ranges of reuse, remanufacture and supplies restoration, considering supporting providers reminiscent of decontamination and conformity evaluation

These actions will assist ship the next advantages:

higher resilience to world shocks and lowered ranges of disruption of the availability of medtech will improve system efficiency via much less interruptions to the environment friendly supply of protected, high-quality care merchandise for sufferers, bettering affected person expertise and outcomes

Precedence 2: modern and dynamic markets

Whether or not regulation, procurement or product choice, the UK medtech market largely embodies the rules and approaches of a free and open market. Whereas regulation exists to guard sufferers by guaranteeing minimal requirements, selection and competitors are the first market mechanics.

Selection, whether or not exercised by sufferers or healthcare professionals, has pushed important advantages. Nevertheless, it’s not with out challenges, primarily the sheer quantity of merchandise in the marketplace. Right this moment MHRA have nearly 2 million completely different merchandise registered to be used within the UK, of which we estimate that round 500,000 completely different product sorts are recurrently used within the NHS. Most particular person trusts will use round 30,000 completely different merchandise – it is a super variety of merchandise to navigate.

To make it tougher, stakeholders report that of the five hundred,000 merchandise recurrently used, nearly all of these declare ultimately to be modern. Though these claims are usually real, they usually check with incremental improvements and enhancements. The problem for the UK well being and care system is intelligently exercising selection throughout such a various vary of merchandise and improvements in a manner that maximises worth for cash, the place affected person outcomes are a elementary part of that worth. To deal with this problem, a standard language and framework for discussing and speaking innovation is required.

This abundance of merchandise contributes in the direction of the broadly acknowledged ‘adoption problem’: merchandise could attain the market, however they will wrestle to be procured and used within the NHS when there are a number of competing merchandise, lots of that are claiming comparable improvements with competing advantages.

Earlier makes an attempt to deal with adoption have primarily focussed on establishing supplementary innovation assist, processes and funding streams that establish and implement merchandise in extremely particular precedence fields. These function along with the primary routes to market. This strategy has improved adoption in sure areas, however the proliferation of schemes created has elevated the complexity that innovators have to navigate. Critically, these schemes are primarily focussed on modern, particular person, pre-market units and are small in comparison with the general scale of the medtech market. Regardless of some particular successes, this strategy has not addressed the underlying structural adoption problem. Which means modern, new applied sciences take longer to succeed in sufferers than is perhaps obligatory.

Contracting and pricing levers might be able to sort out among the problems with the adoption downside. Nevertheless, to deal with the basis explanation for the problem, we have to create a coherent, finish to finish atmosphere that gives elevated readability, alignment and an inexpensive apportionment of danger for innovators, medical and industrial professionals.

Successfully exercising selection

Meaningfully evaluating product high quality, efficiency and pathway price is tough and useful resource intensive. Exercising this selection successfully throughout such a broad vary of merchandise is very demanding in a well being and care system which is already dealing with staffing and financial pressures.

Most assessments rely totally on studies performed by others however there are variations in specification, and requirements between evaluations. By the point they begin to be adopted into the market, most medtech merchandise have been evaluated a number of instances, by a number of completely different folks in opposition to a number of differing requirements, via each formal and casual pathways. There isn’t any nationwide repository of evaluations or consolidated NHS view of product high quality.

These a number of competing evaluations create important price, inefficiency, confusion and frustration for each the UK well being and care system and trade companions, making a scenario the place most suppliers can present at the very least one piece of proof that confirms their product is the most effective. Inappropriate comparators, lack of consideration of the price of change and a niche between theoretical and real-world expertise of utilizing the merchandise are sometimes cited as points. Adopting a brand new product also can require wider adjustments, reminiscent of further person coaching, affected person schooling and even modifications of medical pathways. The assets wanted to implement these could be important, and the system solely has a finite capability to make adjustments. The suitable use of real-world proof in assist of a strong, class based mostly, analysis course of is due to this fact important to assist efficient choice making and selection.

On this atmosphere, regardless of theoretically having important selection and a plethora of improvements to select from, lack of clear proof to permit significant comparisons throughout a category of merchandise means the dangers of transferring away from a identified product are sometimes perceived by the system to outweigh the potential advantages. This leads to comparatively low ranges of switching between merchandise and suppliers in follow. The excessive quantity of product variation and low ranges of product switching impacts the flexibility to attain the fitting product, in the fitting place, for the fitting worth (see Lord Carter’s 2015 report on productiveness in NHS hospitals). The suitable use of real-world proof in assist of a strong, class based mostly, analysis course of is due to this fact important to assist efficient choice making and selection. By focussing on a smaller variety of merchandise that signify the most effective choices for sufferers and the most effective worth for cash, the system might help information significant medical selection and cut back unwarranted variation.

Nationwide medical and technical product management

We have already got some areas of exceptionally sturdy medical management, the place nationwide medical groups construct consensus on specs amongst healthcare professionals, consider merchandise in opposition to greatest follow, affected person expertise and outcomes, and spotlight the place modern applied sciences are most wanted. Sometimes, this occurs for complicated surgical objects, though there are notable exceptions in different areas reminiscent of wound care. Nevertheless, many merchandise, particularly these that aren’t unique to particular person specialisms, don’t get pleasure from the identical degree of medical focus and management throughout a category of merchandise.

Even accounting for native variations in providers, there are extra similarities than variations in how the UK well being and care system makes use of most merchandise. Increasing this clinically led nationwide strategy throughout all areas of medtechwould considerably simplify the industrial panorama for each trade and the well being and care system.

Focussing innovation in the fitting locations

At a strategic degree, the UK well being and care system supplies trade with an general sign of future intent via excessive degree methods such because the NHS Lengthy Time period Plan and the healthcare missions of the federal government’s Life Sciences Imaginative and prescient. Along with this, the medtech trade takes many steps to grasp demand extra granularly, however given the numerous numerous communities of sufferers, healthcare professionals and different professionals throughout the NHS, these alerts could be divergent and disconnected from medical and industrial processes. Within the absence of a transparent central sign throughout the breadth of merchandise, it usually in the end falls to trade to drive the route of product growth.

Trade usually describes the problem of precisely predicting the place innovation can be broadly adopted. Given the chance, price and complexity, it’s logical for trade to prioritise incremental enhancements of present merchandise over growing transformative improvements, even when these might probably have a higher affect on NHS providers. The place trade does take an opportunity on these transformative improvements, the price of any commercially unsuccessful merchandise could be important.

The response to the COVID-19 pandemic has proven trade’s functionality to reply, at pace, to clear granular demand alerts from the NHS. Lateral stream assessments, ventilators and respiratory assist tools had been developed and manufactured quickly in opposition to nationally offered goal product profiles. We have to be taught from this expertise and supply trade with a clearer, extra granular demand sign for it to reply to throughout all merchandise, and the arrogance of intent to purchase via a transparent procurement and commitment-based course of to scale back industrial danger.

Determine 6: causes and actions for precedence 2 – modern and dynamic markets

Determine 6 units out the trigger, downside, key impacts of precedence 2 and the corresponding actions required. These are:

the medtech product panorama is continually altering and product experience exists primarily in specialist pockets – this implies there’s a lack of consistency in product use throughout the NHS. Because of this, the most effective merchandise usually are not all the time these which can be adopted – to resolve this we’d like nationwide medical management for merchandise

radical improvements could be excessive price and excessive danger for trade to pursue and there’s a big selection of divergent stakeholder views on innovation with the NHS, which implies trade will not be all the time assured in what the NHS needs. Because of this, improvements supplied could not replicate medical wants – to resolve this we’d like clear demand signalling

disconnect between analysis course of and real-world expertise of product use and lack of constant specification and requirements for detailed analysis imply NHS and trade assets are wasted on repeated analysis. Because of this, we’re unable to meaningfully examine product high quality and worth throughout lessons – to resolve this we’d like streamlined, class-based product analysis

there aren’t any clear standards to fulfill to explain a product as modern and advantages of modern merchandise usually are not all the time clearly expressed or understood. This implies it’s tough to prioritise probably the most impactful improvements. Because of this, transformative improvements are much less more likely to be prioritised – to resolve this we’d like an innovation classification framework

there’s issue evaluating high quality, efficiency and alter prices over a large product vary, and product adjustments have wider impacts, and capability of the system to make adjustments is finite. This implies there’s lack of switching between suppliers and merchandise and, in consequence, lack of industrial benefit of shopping for at scale. To resolve this, we have to converge actions round an end-to-end innovation pathway

The goals of precedence 2 can be achieved by:

nationwide medical management for merchandise: we should take the superb examples of sturdy medical product focus, consideration of the affected person voice, assist for specification setting, product analysis, and utilization steering, and undertake these rules extra broadly throughout product lessons

clear demand signalling: we should work in the direction of offering trade with a co-ordinated nationwide sign on detailed priorities for innovation by product section. We should search to replicate the precedence of those alerts inside established processes, together with regulatory, analysis, analysis and procurement processes – for instance, exploring choices for quantity commitments or buying at scale to assist trade confidence in bringing new improvements to market whereas securing the most effective worth for the well being and care system

streamlined, class-based product analysis: well being companions should work along with trade to develop a streamlined system of product analysis that’s regarded by each because the gold normal. Along with high quality and value concerns throughout the product pathway, evaluations ought to think about a broad vary of product comparators, the prices and dangers of transition, and incorporate real-world proof from product utilization in specialist NHS check services

innovation classification framework: we should work collaboratively with our stakeholders to agree a significant solution to classify innovation that ought to embody a generally agreed language and a solution to decide the worth of innovation when it comes to affect, be this worth for cash, effectivity, or affected person outcomes and expertise. This framework ought to help the system in understanding incremental versus transformative improvements and prioritising their analysis and adoption

converge actions round an finish to finish innovation pathway: we have to create a transparent, scalable, finish to finish pathway that meets the wants of the UK well being and care system and trade. This can assist the event of the Modern Units Entry Pathway (IDAP) which goals to allow producers to supply their modern units to healthcare professionals and sufferers on the earliest, protected alternative

These actions will assist ship the next advantages:

clearer alerts on what the well being and care system needs means higher readability for trade on the place innovation focus needs to be positioned, and sooner adoption of prioritised merchandise to sort out illnesses and well being points sooner

clearer communication round innovation will allow the NHS to concentrate on probably the most modern merchandise that make the most important affect on affected person outcomes

extra acceptable product choice will cut back the executive burden on well being and care professionals, and result in higher affected person outcomes and higher worth for cash. Sooner adoption of prioritised modern merchandise enhances the UK’s positioning as a terrific place to develop merchandise

Precedence 3: enabling infrastructure

Guaranteeing supply of the medtech imaginative and prescient may even require the additional growth of key enablers. In different comparable sectors, reminiscent of medicines, there are clear programs, processes and information collections. These cowl most merchandise in nice ranges of element and granularity and are underpinned by contractual relationships with trade. The medtech sector has not but developed these enablers to the identical degree of maturity or scope. This has been adequate whereas the sector has been in a comparatively steady and regular state, nevertheless the ever-increasing complexity of the market, the tempo of innovation and the challenges round main shocks such because the pandemic necessitate a brand new strategy that may construct a stronger infrastructure of enablers. This can permit us to be extra proactive within the sector – for instance, through the use of information and stakeholder engagement to drive higher demand signalling.

These very important enablers underpin all of the precedence areas we’ve got recognized, and if we’re to efficiently ship our imaginative and prescient, we should enhance and develop these sturdy foundations.


Present information initiatives

Information continues to be a precedence space for enabling enchancment within the well being sector. The Impartial Medicines and Medical Units Security Evaluate, chaired by Baroness Cumberlege, has resulted within the creation of a Pelvic Flooring Registry and extra concentrate on affected person security. DHSC and NHS Transformation Directorate revealed its closing information saves lives technique in June 2022, setting out how we’re harnessing the potential of knowledge in well being and care whereas sustaining the best requirements of privateness and ethics.

Since January 2021, all medical units have been required to be registered with the MHRA earlier than they are often positioned in the marketplace in Nice Britain. That is enabling a higher diploma of data to be shared throughout the healthcare system and public, whereas enhancing MHRA ’s market surveillance actions. There’s additionally a spread of economic information held by NHS organisations like NHS Provide Chain.

These initiatives (throughout security, regulation, procurement and industrial areas) have tended to be impartial of each other, leading to pockets of very wealthy information however with gaps and difficulties in making a extra joined up image.

Enhancing information requirements and linkages

Information assortment and administration in medtech is at present goal led reasonably than approached holistically for the sector – there are a number of registries, databases and survey collections maintained by completely different organisations on completely different subjects and sub-sectors for various finish functions. The decentralised nature of medtech information means there isn’t a single information normal, making it tough to cross-reference information from completely different sources at a nationwide scale. The size of the market (round 2 million merchandise) additional compounds this complexity. Lack of central oversight limits governance for information growth which means necessary information is commonly missed or tough to search out. The dearth of requirements additionally leads to decrease information high quality. This fragmented information panorama makes it tough to construct up a central image of UK medtech ina constant, clear and virtually helpful manner. Having increased high quality, joined-up, complete information for medtech will make it simpler to check merchandise, lowering search time and making it simpler to make knowledgeable decisions to pick out the fitting product, on the proper worth, in the fitting place.

Encouraging proactive information assortment

Information assortment in medtech is commonly pushed by short-term wants and responses to incidents. This was highlighted within the Impartial Medicines and Medical Units Security Evaluate, which famous that registries are sometimes established solely after questions of safety have been recognized. The flexibility to assemble and perceive information in a extra proactive manner might lead to important affected person profit within the medium time period.

One of the vital necessary classes from the pandemic was the necessity for a extra systematic and proactive strategy to information gathering on tools. There’s a clear want to achieve insights to reply retrospective, real-time or future wanting questions with adequate accuracy, in order that sound, well timed selections could be made routinely and flexibly. We want to construct on this momentum and drive additional enhancements on this house with the event of the Nationwide Gear Monitoring Info System (NETIS).

By encouraging proactive information assortment and bettering information requirements and linkages, we are able to work with our companions throughout the medtech trade and the UK well being and care system to construct the medtech information system over time and progressively cut back the hassle it takes to navigate the present medtech panorama and permit for a higher variety of precedence areas of focus.

Relationship with trade

Creating channels for trade and authorities to have interaction centrally

General, there are various examples of sturdy partnerships and dealing relationships between authorities and the medtech trade, on particular subjects, or in response to particular person occasions. In these relationships could be discovered gold requirements for greatest follow in collaboration, and proof {that a} collaborative mindset could be designed into the avenues via which we work. Nevertheless, many of those relationships concentrate on broader points than medtech alone, or conversely are focussed on responding to very particular wants or incidents. On account of this, authorities and trade can interact in inconsistent methods, pushed by their priorities and pressures at any given time limit, reasonably than constructing a broader strategic relationship centred across the wants of the medtech sector.

To progress our joint priorities, trade and authorities should discover a solution to interact in a extra open and collaborative manner that recognises and acknowledges and commits to sort out them with collective motion. This can solely be potential if the fitting supporting infrastructure to assist that is put in place.

We need to strengthen our collaborative working with trade more and more over time, constructing from particular moments of engagement into programs and processes that information each well being and care system and trade actions. We recognise that the range and scale of the trade makes it difficult to construct a central consultant voice, and that this can take time to develop and ideal – nevertheless, the advantages to the trade and authorities over the long term are more likely to be transformative.

Figuring out precedence areas for collaboration

We’ve already recognized a number of precedence areas the place a collaborative strategy with trade could be notably impactful. These embody:

joint growth of a round financial system strategy that may allow higher utilisation of reuse, remanufacture and materials restoration inside the medtech market, as a part of our actions recognized in precedence 1

working collectively to drive enhancements in information assortment and sharing, together with encouraging the strategy of ‘accumulate as soon as, use usually’

collaborating with trade to grasp inflationary pressures with the view to plan a long-term coverage place as a part of our overarching purpose of ‘proper worth’

We’ll proceed to work with trade on these and different necessary areas as a part of our ongoing dedication to collaborative working.

Determine 7: causes and actions for precedence 3: enabling infrastructure

Determine 7 units out the trigger, downside, key impacts of precedence 3 and the corresponding actions required. These are:

information is focussed on particular person functions (for instance, buying), there’s a lack of nationwide information requirements and ranging high quality throughout sources, common acceptance of lack of transparency, and information assortment is commonly reactive (for instance, a response to an incident) reasonably than proactive. This implies there’s a lack of compatibility between information sources, inaccurate and incomplete information, it’s time-consuming to get the fitting data and there are patches of knowledge with no holistic overview. Because of this, it’s effort intensive to undertake systemic information evaluation so can solely concentrate on a restricted variety of priorities – to deal with this we should construct a trusted information image

no structured mechanism for collective motion between trade and authorities, and authorities and trade select routes of engagement inconsistently in response to their priorities and pressures. This implies relationships are transactional reasonably than holistic and in consequence, it’s tough to agree and execute shared route and technique for the sector. To deal with this, we have to set up a collaborative partnership with trade

The goals of precedence 3 can be achieved by:

constructing a trusted information image – we should improve the proactive gathering of knowledge relating to medical know-how. We should champion elevated information high quality in addition to requirements and linkages and work with all stakeholders to encourage the strategy of ‘accumulate as soon as, use usually’. We’ll guarantee this information is constructed upon, shared and utilized in a constant method with out gaps or discrepancies. This have to be supported by a standard nomenclature and system of markers. We’ll work with our well being and care system companions to create a dependable and trusted image that informs what is required to ship on operational and strategic targets

collaborative partnership with trade – we should set up a tradition of collaborative working between trade, authorities and the medical and industrial communities of the well being and care system. We should create an atmosphere the place frank discussions and transparency are the norm, whereas respecting industrial sensitivities. We’ll use this collaboration to set shared imaginative and prescient and route for the medtech sector

These actions will assist ship the next advantages:

clear and well timed alerts when there are points with merchandise will permit us to take swift motion to make sure continuity of affected person care

extra environment friendly use of present tools and extra clear pricing will assist to attain higher worth for cash

stakeholder settlement on the info image will allow coordinated motion making it simpler to make use of information throughout completely different datasets. This can type a foundation for extra insights and proactive motion to be taken

Precedence 4: particular market focusses

Whereas medtech represents an exceptionally numerous vary of merchandise, nearly all of these are designed, developed, chosen and procured via broadly comparable programs and predominantly face frequent challenges. The overarching imaginative and prescient and priorities of the technique have been developed to be related to all components of this broad sector. Nevertheless, we recognise that some particular segments of the market face specific challenges. In these areas, we’ll work to use the rules of the technique at a extra granular degree. This can be within the type of tailoring the broader components of the technique to greatest match the wants of a specific market, or via supporting the goals of the technique via the addition of particular actions to sort out singular points.

This strategy has already been used with success in different areas of the well being and social care system. There’s important ongoing work round using digital and synthetic intelligence each in medtech merchandise and as standalone merchandise, and throughout the pandemic devoted methods had been adopted to make sure adequate respiratory, renal and enteral capability.

We count on that the areas of focus will change and develop over time as market situations and medical necessities change. At current, we imagine there are 2 essential medtech areas that will profit from an elevated focus:

medtech locally


Medtech locally (home equipment)

The overwhelming majority of medtech spend is in secondary care, however there’s additionally important spend, roughly £1 billion a yr, in neighborhood care, together with main care. These medtech objects are used day after day by sufferers locally and are also referred to as home equipment. They embody continence merchandise, reminiscent of stoma or ostomy luggage, dressings for long-term wound care, and reagent strips for residence testing (for instance, of blood glucose or ketones).

Determine 8: elements of the Half IX Drug Tariff

The determine illustrates the 4 elements:

IXA: common home equipment – for instance, wound care, lymphedema clothes

IXB: incontinence home equipment – for instance, incontinence belts, catheter values

IXC: stoma home equipment – for instance, ostomy luggage and programs

IXR: reagents – for instance, blood glucose testing strips, urine ketone testing strips

Though these merchandise are usually an identical to these utilized in secondary care, locally they’re sourced and equipped via essentially completely different provide chains and mechanisms to succeed in sufferers. Suppliers apply to be listed on Half IX of the Drug Tariff, sufferers are prescribed merchandise (in the identical manner as medicines) and have their prescriptions allotted both via native pharmacies or, given the specialist nature of lots of the merchandise, via devoted meting out equipment contractors (DACs).

The mechanics by which home equipment are offered to sufferers locally have modified little since they had been established within the Eighties, in stark distinction to the fast growth of medtech and the substantial evolution of neighborhood care providers over this similar interval.

Whereas the elemental rules of those mechanics, Half IX prescription and cheap selection stay usually sound, there’s alternative to overview and enhance these preparations to raised replicate as we speak’s operational atmosphere, and to ship higher outcomes for sufferers and the taxpayer.

The particular variations in mechanics and provide chain carry alternatives and challenges alike, and these must be factored right into a extra focussed technique for medtech locally:

selling significant selection: whereas the present system relies on selection, it’s not all the time simple for sufferers, healthcare professionals, or purchasers to train this selection in follow. We intend to assist selection via making it simpler to check, distinction and choose probably the most acceptable merchandise

modernising administrative preparations: as we speak’s system has its roots in a one measurement suits all strategy initially courting from the Eighties. There are important alternatives to rationalise present processes, creating sooner entry and programs which can be higher aligned throughout main and secondary care

embracing new industrial and repair fashions: since its inception, a wide range of new approaches have been developed that as we speak work in parallel to the Half IX system. We have to maximise the chance these present whereas maximising transparency and guaranteeing high quality

These actions will assist ship the next advantages:

sufferers and clinicians can be supported to make higher decisions in regards to the merchandise out there to them to deal with and handle their situations

modernised administrative preparations will streamline and improve the pace of our programs, permitting them to carry out extra effectively

transparency of programs throughout the NHS will allow higher selections and cut back variations in service between locations


Medtech merchandise play an important position in diagnostic providers, that are essential to supporting preventative care and the supply of world main, protected and efficient remedy. The NHS carries out over 1.5 billion diagnostic assessments yearly and greater than 85% of medical pathways contain a diagnostic check (see Merchandise 5: diagnostics capability). Diagnostics are a big a part of the UK Life Sciences sector, with £2.9 billion in turnover and using greater than 15,000 folks within the UK.

Determine 9: elements that sit underneath diagnostics

The determine illustrates the 5 elements of diagnostics are:

imaging providers – for instance, CT scans and MRI scans

scans and scans pathology – for instance, biopsies and blood assessments

endoscopy – for instance, colonoscopy and gastroscopy

physiological measurements – for instance, electrocardiograms or lung perform assessments

genomics – for instance, genetic uncommon illnesses screening

Diagnostic providers embody imaging providers, pathology, endoscopy, physiological measurement and genomics. All these providers are very important to making sure that sufferers get the fitting care shortly and effectively.

During the last 2 years, the COVID-19 pandemic has demonstrated the significance of quick and correct diagnostic testing, genome sequencing and the existence of strong diagnostic infrastructure to course of and share outcomes. The huge adoption of residence lateral stream testing has demonstrated the potential for elevated use of diagnostics exterior formal medical settings to assist earlier prognosis.

Demand for diagnostics is constant to rise and ready lists have elevated following the discount in availability of providers throughout the pandemic, so it’s vital that we proceed to enhance and develop our diagnostic capability. In tackling these challenges, we’ve got a chance to maneuver to a extra patient-centric mannequin of care, and to raised join our world-leading life sciences sector with the NHS to rework elective diagnostics with the newest applied sciences.

Prognosis nearer to the affected person

Neighborhood diagnostic centres ( CDCs ) present a spread of elective diagnostics away from acute services. These centres will cut back strain on hospitals, enhance sufferers’ entry to assessments, improve capability, and pace up prognosis and referral for remedy via a extra productive, environment friendly, personalised and built-in mannequin of care.

Digital and technological transformation

Innovation will play a important position in the way forward for diagnostic providers, so we should be certain that analysis and growth is directed in the direction of diagnostics in a manner that maximises affect. We have to ensure that we keep the concentrate on advancing diagnostic applied sciences and adoption throughout the NHS to assist higher remedy and outcomes for sufferers and assist the NHS to focus assets the place they’re most wanted.

Digital transformation of diagnostics via new applied sciences reminiscent of synthetic intelligence (AI) may even allow the present imaging and pathology workforce to optimise their working patterns and higher assist the expansion in capability of imaging providers. This can rework how folks obtain their assessments and check outcomes, delivering extra correct and well timed outcomes.

Based mostly on broad engagement throughout the diagnostics sector, 4 areas for precedence motion within the diagnostics sector have been recognized that may facilitate elevated entry, earlier prognosis, innovation adoption and effectivity.

These 4 diagnostic priorities are:

1. Elective restoration

We should assist the NHS to undertake extra environment friendly fashions of care that may assist sort out the elective backlog. We’ll set up as much as 160 CDCs by March 2025, supported by acceptable workforce plans. We’ll construct pathology community maturity, and ship enhanced digital infrastructure that may enhance effectivity, interoperability and availability of diagnostics throughout the well being system.

2. Early prognosis

We’ll work to enhance affected person outcomes via early detection and prognosis, which means sufferers can obtain remedy when there’s a higher likelihood of reaching a whole treatment. We’ll utilise further capability and elevated public consciousness and acceptance of self-administered testing constructed via the pandemic to extend uptake of early screening. We may even allow earlier prognosis of most cancers and detection of relapses via the fast introduction of recent genomic applied sciences.

3. Trade engagement

We’ll present clear demand signalling to trade to assist innovation within the UK diagnostics sector. The present NHSE Demand Signalling Programme will work with a medical advisory group to establish and drive improvements that assist early prognosis and may have the best affect on well being outcomes. An NHS-led overview of diagnostics commissioning will guarantee advantages throughout the pathway are recognised, and that regulatory and analysis processes are simplified and clarified. This aligns with the broader medtech priorities of nationwide medical management for merchandise, clear demand signalling and streamlined analysis.

4. Pandemic preparedness

We’ll use the legacy of funding throughout COVID-19 to make sure preparedness for any future pandemic. UKHSA , via the Centre for Pandemic Preparedness, will work together with NHSE and the pathology networks to make sure that diagnostic services are prepared for future pandemics and that present infrastructure and latent capability is able to being mobilised.

These actions will assist ship the next advantages:

offering extra environment friendly and efficient fashions of care and detecting and treating illnesses earlier will assist elective restoration within the well being and care system by lowering strain on acute providers and can enhance affected person expertise and outcomes

entry to CDCs will provide care to sufferers exterior of hospital settings in a manner that’s extra personalised, handy and helps improved affected person entry to healthcare

will provide care to sufferers exterior of hospital settings in a manner that’s extra personalised, handy and helps improved affected person entry to healthcare selling the UK as a thriving world hub of diagnostic innovation and development will assist and improve the UK’s fame as a terrific place to develop merchandise

supporting the well being system to scale up diagnostic testing and genome sequencing quickly and successfully will assist to mitigate the higher impacts on wider society and the financial system of any future illness threats

Conclusions and subsequent steps

Medtech is a big and numerous trade that performs a big position in each the UK financial system and the UK well being and care system. It has largely operated with out important central intervention and approaches to this point have been pushed by want reasonably than via a deliberate strategic strategy.

Medtech merchandise and markets have developed quickly, and along with the adjustments led to by the UK leaving the EU and classes we’ve got learnt from COVID-19 we have to act now to make sure that the sector is sustainable for the longer term, and that our assets are focussed the place they may enhance the general well being of the nation.

We’ll do that by ensuring the well being and social care system can reliably entry protected, efficient and modern medical applied sciences that assist the continued supply of high-quality care and glorious affected person outcomes in a manner that makes the most effective use of taxpayer cash, delivered by our imaginative and prescient of ‘proper product, proper worth, proper place’.

Recognising the work that’s already underway inside the sector, we see 4 key precedence areas for recent nationwide focus:

resilience and continuity of provide

modern and dynamic markets

enabling infrastructure

particular market focusses

This technique units our imaginative and prescient for medtech, and the central strategic components the place we count on to see completely different and elevated focus over the subsequent 5 to 10 years. In growing these plans, we’ll you should definitely think about a number of elements that can be important to success:

a joined-up strategy to the technique: we have to think about the technique as a complete and pay attention to how the completely different components and priorities work together. We can not work in silos

clear, significant metrics: we should set clear targets that instantly align to the core priorities of the technique and have a strong solution to measure progress

sturdy collaboration: we’ll set out a framework for trade collaboration and use this to develop detailed implementation plans for every workstream. Always we’ll be certain we search continuous engagement and suggestions from all our stakeholders together with one of the best ways to have interaction affected person teams

supported and empowered management: we should be certain that senior management throughout the sector is totally dedicated to the imaginative and prescient, and that we offer them with the assist they should embed engagement all through their organisations

implementation capability: lots of the transformations we need to obtain are important, each when it comes to ambition and timescale. We should be certain that we assist the change course of with the fitting assets and abilities

bold however sensible timelines: the imaginative and prescient set out here’s a long-term purpose that we might want to work in the direction of in levels. We should think about tips on how to divide this into milestones with out shedding the momentum that’s already in place

We’re dedicated to realising the advantages that advances in medtech can carry, each to the person affected person, and to the UK financial system. We name on our colleagues throughout trade and the UK well being and social care system to share our ambition and work with us to create lasting constructive change. We’ll proceed to have interaction collaboratively with all stakeholders and seek the advice of on proposed adjustments forward of supply and implementation.

The way forward for the medtech panorama

The medtech technique will ship the next actions:

the Medtech Directorate will arrange the suitable governance constructions to attain the goals set out within the technique

the DHSC Director for Medtech will oversee the governance, implementation and ongoing actions within the sector

Director for Medtech will oversee the governance, implementation and ongoing actions within the sector we’ll work with stakeholders to develop an implementation plan

An implementation plan for the technique can be revealed in early 2023, outlining the deliberate achievements for every precedence.

Precedence 1: resilience and continuity of provide

The implementation plan will purpose to attain the next:

medtech suppliers proactively undertake efficient contingency measures to make sure continuity of provide and interact early to resolve rising issues

a broad medtech sector positioned and led from the UK that excels in any respect levels of product life cycle, from analysis and growth, to design, manufacturing, upkeep, restore and remanufacture

medtech programs are interoperable by default, making exceptions solely the place there’s clear proof of overwhelming advantages for affected person outcomes and security

medtech programs assist reuse, remanufacturing and supplies restoration by default, lowering reliance on susceptible sources of uncooked supplies and the publicity this brings to cost volatility and hostile acts

Precedence 2: modern and dynamic markets

The implementation plan will purpose to attain the next:

for each product kind we’ve got a transparent, recognised medical voice articulating practitioners’ wants for medtech

we’ve got granular readability of the NHS’s priorities for innovation that are mirrored in programs and processes

we’ve got a transparent, readily accessible and clinically pushed nationwide view of the relative qualities of the merchandise out there

conversations have moved away from common phrases of ‘innovation’ to make use of extra particular and significant language

a transparent pathway from pre-registration via to industrial adoption which permits fast development for precedence, modern merchandise

Precedence 3: enabling infrastructure

The implementation plan will purpose to attain the next:

we’ve got in depth protection of medtech information from merchandise being put in the marketplace to their particular use. The info captured has the mandatory granularity and frequency for the chance it’s making an attempt to mitigate

we’ve got clear, readily accessible, constant, and a trusted view of medtech information. Merchandise are simply identifiable throughout datasets with minimal effort and medtech datasets could be linked and used for a spread of functions, not simply what they had been initially gathered for

the NHS and trade work as trusted companions with constant mechanisms to speak NHS demand, assist medical management in trade engagement, encouraging innovation in medical areas of biggest want, planning how improvements can be procured by the NHS to ship sufferers the fitting merchandise, on the proper worth and in the fitting place

Precedence 4: particular market focusses

The implementation plan will purpose to attain the next:

in addition to a big selection of product, clinicians and sufferers have entry to unbiased assets to assist them examine and choose probably the most acceptable product

the processes for entry, upkeep and exitfrom Half IX are modernised to replicate our trendy digital atmosphere and pace of modern product growth

there’s convergence in the direction of good follow working fashions

there’s prepared entry to diagnostic testing, no matter location, enabling earlier interventions and the improved affected person outcomes related to this

there are quick, correct, widespread and personalised diagnostics undertaken near the affected person via CDCs and on the level of care

and on the level of care the UK is a thriving world hub of diagnostics innovation and development, supporting improved and extra inexpensive healthcare right here within the UK and overseas

we’ve got a well being system that is ready to scale up diagnostic testing and genome sequencing in line with the fast and efficient response to infectious illness threats and pandemics

Annex A: strategy to technique growth

1. Establishing the Medtech Directorate

Through the pandemic response, an Oxygen, Air flow, Medical Units and Medical Consumables Programme was arrange collectively by DHSC and NHSE to ship a 4-phase programme of COVID-19 response. By means of the programme, everybody who wanted oxygen or medtech was in a position to entry it.

The pandemic highlighted the worth and have to have a focused, standalone medtech technique. The brand new Medical Applied sciences Directorate inside the division was introduced in Could 2021. Programme actions had been introduced into DHSC in September 2021 and clustered with different medtech coverage to type a brand new Medtech Directorate. The directorate has employees focussing in:

provide resilience and engagement


coverage and regulation


information and evaluation

Publish-COVID, medtech faces a distinct set of strategic challenges, and the aim of the directorate is to make sure that our long-term technique for the sector displays these.

2. Overarching technique growth

We’ve taken a multi-faceted strategy to technique growth that takes into consideration the at present out there proof, the views and desires of our stakeholders, and the broader priorities of the federal government. As a part of this course of, we carried out the next:

cross-government coverage evaluations to grasp the top-level priorities that would affect the sector, align our imaginative and prescient and actions with present coverage, and establish areas the place there was already well-established motion in place, and the place gaps existed the place we might instantly add worth via the technique

information evaluation of present tendencies in medtech throughout a number of present sources to ascertain broad industrial data and the form of the broader panorama

trade roundtables with a wide range of companies and commerce associations to debate probably the most urgent points for the sector, and to current and acquire suggestions on preliminary areas for exploration

worldwide evaluations to ascertain the strategy to medtech by our worldwide friends and decide any areas of consensus and greatest follow that would inform our coverage

focussed sustainability analysis together with a complete literature overview to develop an in depth understanding of the particular sustainability challenges dealing with medtech and floor potential paths to motion

focussed innovation pathway mapping following on from sturdy stakeholder suggestions on the realm, to seize the complete element of present funding and assist mechanisms and decide the diploma of alignment and ease of navigation for innovators

ongoing stakeholder engagement to achieve suggestions and information route of the technique because it developed

Collectively these approaches have given us a broad understanding of the sector from many alternative viewpoints and have allowed us to take these into consideration to construct an bold however achievable imaginative and prescient and technique.

3. Diagnostics

The pandemic gave impetus for the division to take an overarching view of diagnostics and to overview the challenges and alternatives within the sector. Because of this, final summer season ministers requested officers to develop a method for diagnostics that will carry collectively adjustments obligatory for the NHS to:

sort out the backlog in diagnostic assessments

enhance engagement with and use of the diagnostics trade

enhance the effectiveness of diagnostics

use the legacy from funding in COVID-19 testing

Following an preliminary roundtable together with representatives from throughout authorities and trade, the group spoke to over 100 stakeholders from throughout authorities, academia and trade. This included a survey of trade representatives and a sequence of trade webinars, and a medical advisory group led by the division’s Chief Scientific Adviser.

4. Medtech locally (home equipment)

The division began contemplating the necessity, and alternatives, to enhance utilization of medtech inside the neighborhood well being system in 2019. These concerns had been paused to allow the well being system to prioritise its COVID-19 response, and now type a part of the Medtech Directorate core remit.

The strategic focusses had been developed in session with a variety of well being system and trade stakeholders. Given the big selection of differing organisations concerned on this sector, efficient collaboration and engagement can be important: we sit up for working intently with related companions to develop growing readability on the main points of how greatest to attain these targets.

Annex B: areas for shared engagement

1. Alignment throughout authorities – additional element

Many organisations and programmes are already supporting elements of our imaginative and prescient and it’s aligned with, and complemented by, many different wider authorities methods. Throughout these initiatives, we’ve got recognized the next central themes:

levelling up

worldwide management and funding


demand signalling

bettering information

boosting analysis and growth

upskilling and re-skilling

internet zero

Additional element on the particular particulars of those insurance policies, evaluations and initiatives could be discovered beneath.

Levelling up

59% of medtech jobs are exterior South East England, with important UK-wide regional clusters. Elevated concentrate on this trade helps the federal government’s levelling up agenda and can improve job alternatives exterior the South East and London.

The technique will guarantee medtech is well timed, out there and accessible to all no matter location, ethnicity, intercourse or different attributes to deal with well being disparities.

Alignment throughout authorities:

Worldwide management and funding

The medtech technique will assist the ambition for the UK to be a science superpower and world chief. Analysis and growth is a authorities precedence, this can promote innovation inside medtech.

Alignment throughout authorities:


The medtech technique will prioritise and drive innovation inside the sector. It should additionally assist improved administration of SMEs and upskilling of employees to drive innovation and progress and guarantee merchandise are protected and appropriate for all.

Alignment throughout authorities:

Demand signalling

The medtech technique will prioritise clear demand signalling by the NHS and partnership between clinicians, trade and authorities to agree route of the sector. The technique will prioritise streamlined product analysis, and well being companions should work collectively to develop a coherent system of product analysis and establish the place precedence areas are.

Alignment throughout authorities:

Enhancing information

The decentralised nature of knowledge inside the medtech sector means there isn’t a clear single information normal, making it tough to cross-reference and share information. By growing the chance for information partnerships and offering real-world information alongside medical and genomic the medtech technique will assist demand signalling, effectivity, affected person security, worth for cash and innovation.

Alignment throughout authorities:

Boosting analysis and growth

The medtech technique will increase focus and funding in analysis and growth and assist extra collaboration between non-public companies and public companies to extend the potential for innovation. By championing innovation and quick stream applied sciences to market via lowered paperwork, the medtech technique will bolster output of modern merchandise and breakthrough applied sciences.

Alignment throughout authorities:

Upskilling and re-skilling

The medtech technique will assist innovation upskilling and coaching workers by encouraging a vibrant medtech trade. This can allow people to progress inside the trade and develop the talents of the medtech workforce. The technique will assist the voice of teachers inside the medtech trade utilising their understanding of the sector and innovation to make sure a holistic strategy to implementation of the technique.

Alignment throughout authorities:

Internet zero

The medtech technique will assist sustainability and assembly the NHS internet zero goal. The technique outlines the necessity to discover clinically protected and efficient merchandise which can be higher for the atmosphere via reuse and remanufacture.