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EXECUTIVE SUMMARY

 

Medical Technology (MedTech) has the potential to transform the delivery of health and care in our country. It can increase the efficiency and productivity of services in traditional settings, as well as allowing care to be offered in alternative, less resource intensive locations.

MedTech is an engineering based industry, characterised by rapid, often iterative product design and development, and a large number of small and medium sized enterprises (SMEs). The industry is, rightly, highly regulated, operating in a European-wide system which has evolved with significant input and leadership from the UK. For future growth and success, the MedTech sector must be recognised in its own right, with evidence, regulatory and adoption needs that differ significantly from those of biopharma.

Multinational or small, MedTech companies effectively have only one customer in the UK: the NHS. The NHS is the biggest single payer health system in the world, and recent developments are precipitating the joining up of all public services which determine health status. This gives the UK the potential to become the best place in the world to develop, launch and assess the value of innovative medical technology. This, in turn, becomes a significant engine for economic growth.

To realise these opportunities, the MedTech industry needs an integrated domestic and trade policy, offering a degree of certainty whilst leveraging the flexibilities that leaving the European Union may bring. The NHS must also provide a local market that is receptive to, and values, innovation.

The recommendations in this paper aim to provide a platform from which those policies can be developed.

 

If this platform can be achieved, there is scope for building a stronger sector. For that to happen a focus is needed in two areas particularly.

Firstly there should be a specifically tailored programme to support the growth of British MedTech SMEs, including a focus on commercialisation and early stage dissemination, building on the rich experience from the healthcare programme of the Small Business Research Initiative. A targeted NHS spend on SMEs and financial support / carve-outs is needed for small companies, to ease any increased regulatory burdens following Brexit.

Secondly the commitment of the NHS to play a full role in the economic growth of our country can best be demonstrated by a more enlightened attitude towards procurement. What is needed is a series of initiatives that pursue a more strongly data driven approach, that is less reliant on the use of intermediaries and is linked to health outcomes as well as price. This might be Innovation Partnership Procurement exemplars specific to MedTech, Individual technology tariffs, linkages to the GIRFT programme and the repatriation of NHS Supply Chain which would reduce costs for both suppliers and the NHS.

With these in place, it should be possible to achieve much more for the NHS and the wider economy as well as for the companies in the sector. We also propose a MedTech specific ‘catapult’ with access to large, regional data sets and a receptive local market. Data should be collected on real world and real time outcomes specific to MedTech evidence needs and outputs. This could support and enhance meaningful acceleration of some of the Grand Challenges themes and include risk/reward share and a commitment to adapt working practices.

 

 

THE RECOMMENDATIONS

 

ABHIs recommendations represent a clear view for UK MedTech, focused on five themes:

  1. 1. Ensuring regulatory stability and leveraging the global reputation of UK regulators

 

  1. 2. Maintaining favourable terms for trading within and outside the EU, along with an integrated domestic policy to support investment, competitiveness and export performance
  2. 3. Support for manufacturing, including continuing to address the domestic skills gap and ensuring that the UK can attract the best talent globally
  3. 4. Bespoke support for our vibrant SME community

 

  1. 5. Enhanced collaboration with the health and care system.

 

 

Our recommendations fall into two categories and are summarised below: A. Relating specifically to the MedTech sector.

  1. B. Applying across all manufacturing sectors, including MedTech.

 

 

  1. A. MEDTECH SECTOR-SPECIFIC

 

Ensuring regulatory stability and leveraging the global reputation of the UK

 

  1. 1. A pragmatic UK approach to compliance with the current and future European regulation for medical devices
  2. 2. The UK remaining part of the CE marking regime for MedTech. This requires mutual recognition of the CE-mark between the UK and EU and, where practicable, similar arrangements with other jurisdictions
  3. 3. UK Notified Bodies (NBs) remain within the existing European network and oversight mechanisms. They should continue to be designated to assess devices for the EU and UK markets
  4. 4. Authorised Representatives of manufacturers based outside the EU should still be allowed to be domiciled in the UK
  5. 5. MHRA retains influence over, and oversight of, the EU regulatory system, through formal engagement with the European Commission’s new stakeholder body, the Medical Devices Co-ordination Group (MDCG), and has full access to Eudamed
  6. 6. MHRA increases influence over global regulatory harmonisation, through UK membership of the international medical device regulators forum (IMDRF).

 

  

Maintaining favourable terms for trading within and outside the EU, along with an integrated domestic policy to support investment, competitiveness and export performance

  1. 7. Increased MedTech specialists in the overseas Consulates and Embassies

 

  1. 8. Launch a MedTech Export Campaign – a designated, long term, country by country strategy for UK MedTech companies, led by market specific MedTech champions
  2. 9. ABHI is represented in ministerial negotiations where those negotiations relate to new MedTech trade deals.

 

Support for manufacturing, including continuing to address the domestic skills gap and ensuring that the UK can attract the best talent globally

10.Continued application of International Standards for Quality Management Systems (ISO 13485) and Risk Management (ISO 14971)

  1. 11. An assessment of the training places available to support MedTech companies and a focus on the training of Regulatory Affairs professionals.

Bespoke support for our vibrant SME community

 

12.Cabinet Office targets for spend on SMEs should be included as part of the inspection regime for all NHS organisations

13.The NHS should pursue a more strongly data-driven approach to procurement that is less reliant on the use of intermediaries

14.Appoint a high profile, cross-government MedTech SME Champion to address policy anomalies. Enhanced collaboration with the health and care system

15.A statement of intent, from the highest level of both NHS England and NHS Improvement, to leverage the full potential of the service to drive economic growth

16.A clearly signposted “front door” for technologies to be incorporated into the “NHS test bed”

 

  1. 17. Utilise the whole systems thinking inherent in the Sustainability and Transformation Plan (STP) approach to inform the intelligent, outcomes-based procurement of MedTech

18.Facilitate pre-procurement discussions with companies to develop criteria and methodology for awards, and create new contracting methods which allow dialogue and negotiation during the tendering process

19.Alter the payment and incentive systems to support the adoption of MedTech via individual technology tariffs, reconfigure the NICE Technology Appraisal Programme to support wider inclusion of MedTech and the funding mandate and introduce a “comply or explain regime” for all NICE guidance

20.Create an “Innovation Fund” to “pump-prime” technologies at a STP level where upfront expenditure is needed to release future savings

21.Remove duplicative procurement arrangements, ensuring that any intermediaries provide added value.

 

 

  1. B. FOR ALL INDUSTRY SECTORS, INCLUDING MEDTECH

 

Maintaining favourable terms for trading within and outside the EU, along with an integrated domestic policy to support investment, competitiveness and export performance

22.Ensure free trade with Europe on the most beneficial terms possible 23.Protect other Free Trade Agreement benefits with non-EU countries 24.No increased customs duties against imports into the UK

25.Ensure UK Customs laws facilitate trade without onerous barriers to duty reliefs or fair customs treatments

26.Align regulation to facilitate trade

 

27.Minimise any increased administrative costs and border delays

 

28.Allow transition measures to provide for a reasonable time-frame for change implementation without resulting cost increases

29.Facilitate less regionalisation/duplication of funding and human resource for exporters 30.Increased grant funding for SMEs to support export activity

31.Introduce a UK Export Tax Credit Scheme.

 

Support for Manufacturing, including continuing to address the domestic skills gap and ensuring that the UK can attract the best talent globally

32.Ensure the continued availability of skilled labour and access to the best talent globally 33.Create better opportunities to access funding for manufacturing outside the EU 34.Impose no additional regulatory requirements with respect to manufacturing

35.Expand the scope of regional growth funding to increase support for manufacturing relative to research & development

36.Take urgent steps to reduce business operating costs, through both real terms reductions in taxation and a moratorium on further stealth or indirect tax impositions.

 

 

CONTEXT

 

When we began this report, the UK was firmly in the European Union, and had a strong life sciences industry based on outstanding biomedical research in both world-class universities and internationally-renowned teaching hospitals. We also perceived the NHS as being a potentially crucial asset in further developing the life sciences industry. It was not unreasonable, we believe, to assume that some of the £120 billion spent annually on the NHS should be helping to drive success in this sector, fuelling economic growth and generating increased tax income

on which to base our public services. Since the UK voted to leave the European Union, the importance of these principles have, if anything, been amplified.

Given the uncertainty for the financial sector and heavy manufacturing in a future potentially outside the single market, it seems clear that the life sciences industry will provide a crucial pillar for future economic growth. This will, of course, require a targeted industrial strategy and may benefit from a future regulatory regime. These ‘sunny uplands’ are not likely to be easily reached. More effort and resource will be needed to ensure the success of this sector both by creating a system in which the NHS is allowed to be a receptive market for useful innovations and by ensuring that the commercial entities that are required to support economic growth are viewed as partners in making the UK a global hub for innovation in healthcare.

 

Professor, Sir John Bell

Regius Professor of Medicine, Oxford University

Introduction to the Accelerated Access Review of Innovative Medicines and Medical Technologies

 

 

 

 INTRODUCTION

 

ABHI is the leading medical technology industry association in the UK. We are a community of over 250 members, from small UK businesses to large multi-national companies. Technologies produced by our members are essential to the delivery of modern healthcare and contribute to improvements in the quality and efficiency of care provided by the NHS. The sector also has an important role in contributing to the growth of “UK PLC”, employing around 90,000 people in 3,000 companies with a turnover of some £17 billion, and has seen employment growth of 11% in recent years (Department for Business Innovation & Skills, 2011; 2012;2016; Department of Health, 2011). The MedTech industry is an engineering sector, characterised by rapid, iterative product development, a large number of small and medium sized enterprises (SMEs) and truly international ownership. The implications of Britain’s decision to leave the European Union, and the development of an industrial strategy through this lens, may play out differently for companies depending on their circumstances:

  • Large multinationals these companies consider potential locations for investment in new, and the renewal of existing facilities and activity, in a global context. Whilst they are used to managing

currency fluctuations, a consistently weaker exchange rate will impact on such plans. A recent survey of ABHI members has indicated that current uncertainty is already impacting on investment decisions. Products manufactured, assembled or distributed in the UK will typically have touched many other countries in the source of raw materials, components and processes

  • Disruptive SMEs these companies rely on strong research & development inputs, close collaboration with innovators in the health and care space and a receptive local market
  • Established, manufacturing SMEs for these companies, the terms of trade and support for manufacturing are fundamental. A weak exchange rate impacts on imported raw materials and ingredients and risks offsetting advantages for finished product pricing. Companies also need a receptive local market to establish credibility for exports.

 

 

THE RECOMMENDATIONS

 

Ensuring regulatory stability and levering the global reputation of UK regulators

 

ABHI recommends a pragmatic approach by the UK to the regulation of medical devices to replace current European arrangements. Such an approach would be built on specific elements of existing regulations that are beneficial for UK MedTech and need to be fully compatible with those regulations as they evolve.

The principles crucial to this would include:

 

  • The UK remaining part of the CE marking regime, requiring mutual recognition of the CE mark (at least for MedTech) between the UK and EU
  • UK Notified Bodies (NBs) remaining within the network of 50 EU NBs, overseen by MHRA and designated to assess devices for the EU and UK markets, and for remaining members of TEAM-NB (EU network)
  • Authorised representatives of manufacturers outside of the EU continuing to be based in the UK

 

  • MHRA retains influence over, and oversight of, the EU regulatory system, through formal engagement of MHRA in the European Commission’s new stakeholder body, the Medical Devices Co-ordination Group (MDCG); and full access to Eudamed (EU-wide pre, and post-market data, registration of economic operators, details of clinical investigations etc.)
  • MHRA increases influence over global regulatory harmonisation, through UK membership of the international medical device regulators forum (IMDRF).Whilst alignment with other industry sectors (particularly New Legislative Approach products) is desirable, it should under no circumstances be to the detriment of patient safety or innovation.

In the short and medium term, this approach would require a large degree of continuity with the current and future EU system, whilst in the longer term we believe it would provide opportunities for the UK to negotiate bilateral deals, such as mutual recognition agreements (MRAs) with non-EU countries and membership of the medical device single audit programme (MDSAP). MDSAP is a global initiative to allow for some mutual reliance on device assessments in other systems and is not presently available within the EU. Our suggested approach would also allow the UK to negotiate mutual recognition with other countries, and with the EU as part of any future trade deal.

Facilitating access to our own impressive post-market data could improve such deals, as well as increasing the pool of data used to make important patient safety decisions. Aligned regulation will also facilitate trade.

Furthermore, we believe that the MHRA is widely acknowledged as perhaps the pre-eminent competent authority globally. There is also a trend to the global harmonisation of regulatory processes which is based on the “New Legislative Framework” pioneered in Europe with significant input from the UK. With carefully crafted policy in this area, there is no reason why Britain’s global leadership cannot be only be maintained, but also be used as a significant engine for growth. Future regulatory approvals in the UK need not be light touch and certainly no less robust than in other jurisdictions, but they could be quicker, better, and, aligned to a receptive NHS (see below), create the environment for the UK to be the world’s best location for MedTech.

 

 

Maintaining favourable terms for trading with and outside the EU along with an integrated domestic policy to support investment, competitiveness and export performance

These recommendations consider two fundamental impacts of tariffs and any changes in the existing regime: • Their potential to impede trade

  • Their impact on the supply chain for manufactured goods, with a large part of finished product value currently being imported from Europe.

The UK currently trades with the EU and the rest of the world as part of the EU Customs Union, and on terms set by the EU. Tariffs on trade between the UK and the EU would lead to higher costs for manufacturers and higher prices for consumers, including the NHS. Customs controls would increase the administrative burden on companies, and revised border controls could make crossings between the UK and continental Europe less predictable, resulting in longer lead times.

Manufacturing of medical devices often includes the importing and exporting of components to be incorporated into finished products. Likewise, finished or unfinished goods are shipped around Europe for other manufacturing processes, such as sterilisation, packaging, cleaning or maintenance.

The imposition of tariffs on these activities will significantly increase the financial burden on manufacturers, as well as impacting on those contract and component manufacturers and services who are often seen as industry leaders in their own right.

Post-Brexit, ABHI seeks arrangements that support trade and that do not impede the supply chain for manufactured goods.

This would mean:

 

  • Free trade with Europe on the most beneficial terms

 

  • No loss of other Free Trade Agreement benefits with non-EU countries

 

  • No increased customs duties rates assessed against imports into the UK

 

  • UK customs laws that generally facilitate trade without onerous barriers to duty reliefs or fair customs treatments
  • Aligned regulation which facilitates trade (our regulation recommendation is relevant) • Minimising increased administrative costs and border delays
  • Transition measures to provide for reasonable time-frame for change implementation without resulting cost increases.

We also believe that there is considerable scope for improved support for trade and export. The Department for International Trade has great expertise in supporting companies in overseas markets, and should use this opportunity to build on what has proven to be most impactful. We believe that there is the opportunity to work more closely with organisations such as ABHI who can provide “in-UK” support, thereby releasing resources to individual markets where they are most needed and best deployed.

 

 Our detailed recommendations would be:

 

  • Dedicated and expert support in UK overseas posts, provided by people who understand MedTech and can build (or have built) long-term relationships. Additional resource requirements can be offset in the UK, where the industry associations can do this in cooperation with Government
  • There needs to be both more focused and less duplicated support in UK regions for MedTech. For example, at present, there is much support available but it is very difficult to navigate, particularly for SMEs, and there is also much variability across the UK –Wales, Scotland and Northern Ireland all do more to support SMEs to export than does England. In England support from Local Enterprise

Partnerships (LEPs) is stronger in some areas than others – effectively “a postcode lottery”. There is need for well-resourced signposting, balancing individual, local initiatives against a national offer. We believe that a helpful forward approach would be to focus regional resources on inward investment, whilst coordinating support for export at a national level

  • Grant support for companies to export has declined. Trade Access Programme grants (TAPs) for trade shows and missions remain accessible, but support is now very limited. These changes will have a significant impact if sterling remains at a low level. ABHI has seen a fall in companies going to Arab Health and other long haul trade shows. Under the 2010-15 Government, TAPs went from £7 – 15m, with a large increase in companies going overseas
  • Colleagues in the industry association, GAMBICA, surveyed their members during this period and concluded that every £1 of TAP support generated £70 in business won. This has now reduced, a TAP budget of £30M across all sectors 15 years ago, is now just £6M
  • We believe DIT should build designated, long term, country by country strategies for MedTech exports, with market specific MedTech champions, possibly drawn from industry, in each. Priority markets currently focus on size of market without consideration of accessibility, barriers to entry or suitability for British SMEs. BRIC economies, for example, with high import tariffs and regulatory hurdles

and whose geography is logistical challenging, may not necessarily be priority markets for a SME dominated sector

  • For the long term, a cross-government approach, involving, for example, MHRA and the National Institute for Health and Care Excellence (NICE), could help target MedTech markets with a bespoke approach. ABHI’s work in Texas, with support from DIT has been helpful in this regard, and has also opened up opportunities for inward investment from Texan companies and healthcare systems.

 

Support for manufacturing, including continuing to address the domestic skills gap and ensuring the UK can attract the best talent globally

Current government policy has recognised the skills gap in UK industry and plans have been put in place to address this. This has the potential to address company growth limitations as well as maintaining the existing skills base in an ageing workforce.

 

While the UK’s manufacturing sector continues to suffer from a significant skills gap, new immigration policy is also needed within the context of Brexit, to allow manufacturers to recruit the workers they need. One ABHI member with a large manufacturing and R&D facility in the north of England, for example, has 15% of its skilled workforce composed of non-UK nationals. Uncertainty of continued UK citizenship or residency may exacerbate a shortage of skilled labour.

Skills specific for the MedTech sector and the availability of training places also need consideration. There are, for example, recognised shortages of polymer process engineers and regulatory professionals available to the sector.

Investment and competitiveness will be encouraged by policies that help early stage companies and established SMEs to refine their products and incorporate materials and technologies in ways that add the maximum value for end-users at the best possible price.

ABHI’s recommendations relate to support for R&D, manufacturing and particularly strongly to the unique UK relationship between the MedTech industry and the NHS.

Implications for government policy flow from all aspects of this, particularly:

 

  • Support for R&D input into medical device technology should continue and expand. This needs to cover basic research, translation and clinical evidence acquisition
  • Specifically for manufacturing, aspects of R&D will be relevant but it will be important also to ensure the continued application of globally accepted International Standards for Quality Management Systems

(ISO 13485) and that for Risk Management (ISO 14971). These standards have recently been updated to include new responsibilities and applicability to the current and future EU regulatory regimens. It will be important to avoid adding additional regulatory requirements with respect to manufacturing

  • Compared with support for R&D, limited State Aid compliant funding is available for manufacturing in the UK. Regional growth funding scope should be expanded to all areas provided agreed criteria are met. This has the potential to enable investment in existing infrastructure, and to prevent closure of UK based manufacturing facilities, as well as leading to new manufacturing investment.

Over and above these points, urgent steps are required to reduce business operating costs, through both real-terms reductions in taxation and a moratorium on further stealth or indirect tax impositions.

Operating costs for manufacturing industry are high and, even with the planned reduction in Corporation Tax, are likely to remain at around 22% by 2020 according to the Confederation of British Industry. These are fundamental to the cost of doing business and include:

  • High input costs, such as energy (highest in Europe) water and carbon reduction impositions

 

  • Existing demands from customs duty, including the operational costs of documentation with some processing only taking place during working hours and concerns that SMEs won’t reach ‘trusted partner’ status for customs purposes
  • Business rates, which are among the highest in Europe

 

  • Other recent tax burdens, including the Apprenticeship Levy and insurance tax premium of 2%.

 

 

Bespoke support for our vibrant SME community

 

SMEs face several peculiar challenges at the current time. Small companies are particularly vulnerable to currency fluctuations. The cost of imported components increases immediately, whilst MedTech is not a sector which can quickly turn on new customer bases to capitalise on favourable exchange rates. The general uncertainty associated with Brexit has made access to finance difficult, and increased regulatory burdens have fallen disproportionately on smaller companies.

Significantly, the NHS has become an increasingly hostile environment for suppliers. NHS Supply Chain has an explicit policy of reducing the number of suppliers, and decisions are increasingly made on acquisition cost with no reference to overall value. Such initiatives are particularly damaging to MedTech companies as they only have one customer, the NHS. As well as the economic cost of companies failing, there is a cost

to the health of our nation. SMEs provide a disproportionate amount of innovation in niche and low volume areas, where larger players tend not to operate. Any loss of companies results in a corresponding loss of developments in medical care. We recommend:

  • Cabinet Office targets for spend on SMEs should be included as part of the inspection regime for all NHS organisations. In 2010 a target was set for 25% of central government’s contracts to be awarded to SMEs. In 2013-14 26% of central government spending reached SMEs, achieving the aspiration a year early. In August 2015, the target was extended to 33% by 2020. According to research by the Centre for Local Economic Strategies every £1 spent by a local authority with local SMEs generated an additional 63p of benefit for their local economy, compared to just 40p generated by large local firms. When combining the data for countries for which reasonably good data are available, SMEs account for 52% of private sector value added. A review by the Greater Manchester Academic Health Science Network has demonstrated that merely focusing on the accurate collection of data on local SME spend can contribute to NHS organisations being significant vehicles for local economic growth
  • Whilst EU procurement procedures owe a lot to UK policy input, and would be widely regarded as largely sound and helpful, aspects of UK contracting patterns are unhelpful and especially so for SMEs. Use of frameworks tends to kill the market and to exclude the SMEs which have both

contributed to, and benefited from, the development of the NHS. It is the intermediary organisations that have facilitated this, and ABHI recommends that the NHS should pursue a more strongly data-driven approach to procurement that has the potential to render intermediaries less significant, possibly taking their costs out of the value chain

  • SMEs in all sectors often cite frustration that some elements of government policy advance small companies as critical elements in the growth of UK plc, whilst others seem designed perfectly to make the costs of doing business prohibitive. MedTech SMEs are unique in that they have only one customer and that customer is, in effect, the government. There is a need for a high profile, cross government MedTech SME Champion to address these anomalies and maximise the contribution of the sector to the UK economy
  • A key stage in the growth of any indigenous company is the point at which it begins to export. This allows companies to scale up, which has consistently been identified as a problem for the UK. ABHI believes that the government should offer tax credits for SMEs against costs related to their export activities.

 

 

 

Enhanced collaboration with the health and care system

 

The biggest opportunity for the UK to develop, nurture and attract MedTech companies of all sizes is the NHS. It is the biggest single payer health system in the world, and represents an almost unlimited opportunity to provide a test bed for innovative medical technology. It is widely acknowledged that the NHS has failed to take this opportunity. As early as 2004 the Healthcare Industries Task Force described the NHS as a “late and slow adopter” of new technology. Since then numerous initiatives have aimed to improve the pull of innovation into the NHS, most recently the Accelerated Access Review (AAR). Despite this, seldom a week goes by when the ABHI does not hear of members exiting the UK. A fragmented, complex market, slow decision making,

the inability to spread proven treatments and a hostile procurement environment, are all frequently cited as reasons. Integrated domestic policy needs to encompass the £120bn of public spend on the NHS, which has played a large part in creating the vibrant ecosystem for medical technology that exists in the UK. Now is the time to realise that potential.

The NHS has failed to use procurement to buy solutions that reduce costs and improve outcomes, and has, instead, focused almost entirely on simple cost-harmonisation and standardisation. This is exacerbated by the fact that the fragmented nature of NHS organisations means that investments in one part of the system that produce benefits in another, cannot be recognised. Investments that have a clear, whole systems benefit, simply do not happen.

The potential for this to change for the NHS in England now exists with the creation of the 44 Sustainability and Transformation Plan footprints (STPs). Each of the STPs is required to manage its combined health and social care budget with a view to achieving financial balance as a system, rather than as atomised parts.

STPs have the opportunity to use procurement as a lever, both for local innovation and cost reduction in patient pathways. These pathways have historically been fractured by the separation between the

commissioning and provider parts of the NHS. This has led to care which is poor for many users and has beggared some parts of the NHS at the expense of others.

The opportunity for STPs is to create pathways which are end-to-end. This would mean the rigorous identification of costs, such as those generated by length of stay and infection, across geographies and the reduction of those costs, through procurement of innovative and appropriate evidence-based technologies. MedTech, thus, contributes to the reduction of both costs and variation. This approach has already been trialled in Sweden, for example, and the methodologies, as reported by the Boston Consulting Group in 2015, are in place to make it work.

One of the features of NHS accounting is its ability to record ‘programme costs’. This means that there is good understanding of different costs for the same treatments, associated with different outcomes across geographies. These differences have however been hard to act on, despite the concept of ‘Right Care’ and the publication of the NHS Atlas of Variation. STPs make it possible to see these bundles of costs and outcomes across the system.

 

 

Our specific recommendations in this regard include:

 

  • A stated commitment at the highest level from NHS England and NHS Improvement to leverage the full potential of the service to drive economic growth
  • A clearly signposted “front door” for technologies to be incorporated into the NHS “test bed”. This may be through the medium of the Academic Health Science Networks
  • Utilise the whole systems thinking inherent in the STP approach to inform the intelligent procurement of MedTech
  • Facilitate pre-procurement discussions with companies to develop criteria and methodology for awards, and create new contracting methods which allow dialogue and negotiation during the tendering process
  • Alter the payment and incentive systems to support the adoption of MedTech via individual technology tariffs, a reconfiguration of the NICE Technology Appraisal Programme to support wider inclusion of MedTech and the funding mandate, along with a comply or explain regime for all NICE guidance
  • Innovation Fund to pump-prime at STP level where upfront expenditure is needed to release future savings
  • Remove duplicative procurement arrangements, ensuring that any intermediaries provide added value.

 

 

CONCLUSION

 

The MedTech industry has the ability to create a virtuous circle for the NHS, the patients it serves and “UK PLC”. Innovative medical technology increases the efficiency of healthcare delivery and improves patient outcomes. The NHS could potentially be the global destination of choice for such technologies and the associated development of indigenous companies, and associated economic growth. Achieving this needs a coherent, integrated set of domestic and trade policies. This paper has outlined what some of those policies need to be.