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MedTech landscape review March 2019
2 3
Foreword
This guide has been produced • Robustly assessing and This guide is the first step. This is an exciting time for the the NHS, in common with many In terms of finance, patient
because the AHSN national prioritising game-changing It focuses specifically on the Medical Technology (“MedTech”) other health systems, is looking capital has emerged in recent
network thought that there technologies for national support; MedTech innovation pathway industry. Healthcare systems for solutions that will enable years as one solution that could
might be an opportunity • Facilitating access to cutting- and opportunities in England. around the world are increasingly earlier diagnosis of disease, help companies survive through
to adopt a systematic and edge R&D, spanning regional It builds on the work done by looking for innovative solutions address unmet needs in mental the long process of securing
coordinated national approach boundaries to complement the Office for Life Sciences in the that will address pressing needs, health, offer new solutions to regulatory approvals and
to supporting MedTech the work of AHSNs; Accelerated Access Review by while advances in science cancer and rare diseases, and for economic endorsements based
innovation, building on the • Connecting companies to incorporating recent changes. and technology are opening complex multi-morbid patients. on real-world clinical evidence.
support provided by the 15 high-tech manufacturing advice; This guide provides signposting up new possibilities. Often Some of these needs are more Patient capital is a very long-term
Academic Health Science • Partnering with leading NHS to some key organisations who these advances sit at areas of obvious candidates than others form of investment that offers
Networks (AHSNs) to the providers seeking to adopt can offer up-to-the-minute convergence: between different for MedTech innovations and all a support mechanism for highly
NHS and to industry. There game-changing innovations; advice. In the future the AHSN clinical disciplines and between are likely to involve new devices promising scientific ideas. The
are opportunities to do this • Offering guidance to AHSNs Network intends to look at the industries. The boundaries of some sort for diagnosis, drug prize for companies able to access
throughout the innovation as they support MedTech innovation landscape in Europe of MedTech are increasingly delivery or as aids to support patient capital is the potential
journey by focusing on the innovators through market to understand what aspects we blurred by convergence with bio- independent living. for large, long-term returns from
following potential themes: access activities. can learn from and import here. technology, telecommunication, servicing global markets for
artificial intelligence and even The sheer diversity of the their products.
consumer health and wellness. MedTech sector means that,
while there are common aspects But the goal to support the
It is right to look some way into to the innovation pathway, MedTech industry to thrive is not
Acknowledgements the future, as the new ideas of there is no standard approach just about finance. The recent
today will enter the market to that all can follow. Some Life Sciences Sector Deals take
We are grateful to the members of the AHSN MedTech INN steering committee – Piers Ricketts, Rob Berry, address the pressing needs of innovations provide immediate forward ambitions set out in
Mike Burrows, Professor Mike Hannay, Malcolm Lowe-Lauri and Richard Phillips. From AHSN Chief Officers some years hence. Companies patient outcomes and financial the Accelerated Access Review
we also received insightful comments from Professor Gary Ford and Liz Mear. Gary’s expertise on atrial with game-changing innovations benefits that make them readily to make the entire MedTech
fibrillation was invaluable, as was the support of Faye Edwards and Dr Amanda Buttery in this area. Julie that incorporate cutting-edge adoptable, while other highly innovation pathway work better
Hart provided helpful insight on the Oxford diagnostics cluster. science have the potential to promising scientific ideas will for patients, clinicians and
achieve significant population- require significant market- innovators and for UK plc.
We are also grateful to the companies who are the subject of the case studies in this document for their level health impacts. These are making activities through
time and support. Finally, warm thanks to the team at PA Consulting for their tenacity and attention to the innovations with greatest service change and financial Piers Ricketts
detail – Jonathan Pearson, George MacGinnis and Caroline Wright. potential to scale and address reforms before they can sustain Chief Executive at Eastern
global markets. In particular company growth. Academic Health Science Network
4 5
Contents 1 What is MedTech?
The MedTech sector comprises the convergence of digital and Companies within the MedTech
Foreword 3 businesses developing, medical devices in connected sector can be broadly classified
manufacturing and selling medical devices, especially into two groups:
1 What is MedTech? 5 medical devices, supported by in new forms of diagnostic
an extensive network of service testing, the application of
2 The MedTech industry in England 8 and supply businesses1. The artificial intelligence, and the “Core”
sector sits within Life Sciences emerging fields of precision and
alongside Bio-Tech and is regenerative medicine. Scientific MedTech
3 Navigating the innovation pathway 10 characterised in particular by advances such as nanotechnology
the influence of medical device and robotics are also opening Includes all businesses whose
regulations and by the health up new possibilities. More primary business falls under
4 Identifying and developing regional strengths 29 economic considerations that generally, medicine is moving developing and producing
impact on adoption and diffusion towards a more preventative their own MedTech products.
5 Achieving growth 31 in key customer groups, such and personalised approach,
as the NHS. The diversity of and MedTech has a crucial Core MedTech accounts for
MedTech has resulted in an role in this. 70% of the companies and 80%
6 References 35 innovation pathway that is of the turnover in the MedTech
less clearly defined than that Medical devices remain central to sector (excluding digital).
for pharmaceuticals. understanding the scope of the
medical technology sector, and
This guide sets out key features the World Health Organisation MedTech
of the industry, the innovation (WHO) definition serves as a
pathway, some regional clusters useful guide to what is covered “Service and
and some examples of UK by this wide-ranging sector:
companies who have achieved Supply”
successful growth. “An article, instrument,
apparatus or machine that Includes Contract Research
Fresh opportunities are opening is used in the prevention, and Manufacturing
up in the MedTech sector diagnosis or treatment Organisations, suppliers of
driven by the growing need for of illness or disease, or consumables and reagents,
healthcare systems to deliver for detecting, measuring, providers of specialist legal
greater value and fuelled by restoring, correcting or and regulatory expertise,
advances in science and the modifying the structure medical device design,
convergence of technologies. or function of the body for analytical, IT, recruitment and
Healthcare systems globally some health purpose” logistics services as well as
are looking for solutions that finance businesses specialising
enable earlier diagnosis of In keeping with this broad in MedTech investments.
disease, new treatments and definition, the MedTech sector
improved patient experience, covers technologies ranging
such as the ability to take high from single-use consumables
quality care closer to home. to complex hospital equipment
Significant trends in recent and including both digital
years include the evolution of health and In-Vitro Diagnostics
drug-device combinations, (IVD) products. ➜
6 What is MedTech? What is MedTech? 7
Academic Health The MedTech Government policy in England
Science Networks Innovation National is on increasing the emphasis
Precision on achieving an impact from
medicine Network innovation on the health and
Academic Health Science
Networks (AHSNs) are care system, rather than just
Treatments may The AHSNs have established a
be approved pioneering new ways sponsoring the development
MedTech Innovation National of the innovations (although
subject to use to spread and adopt
of a companion Network (INN) to enhance the this clearly continues). A
innovations in healthcare.
diagnostic awareness and support given to particular focus for the AHSN
Stand-alone Biotech First licensed in 2013, they
the MedTech sector in England Network will be on identifying
software and pharma have become a vital part
by the AHSN Network to and supporting innovations
of the country’s health
can be a Medical device; Innovation increasingly accelerate the development of with the potential to scale and
involves co-development of economy, connecting and
while many ‘health apps’ innovations and their adoption achieve significant population-
devices for manufacturing, brokering partnerships
are not regulated they can by the NHS. It is one of nine level impacts in the NHS within
be subject to the same delivery and monitoring between health and care,
‘networks of networks’ to the next 5-10 years. This
health market economic outcomes of novel academia, the third sector
support developments in areas means working with industry
considerations. treatments and industry. AHSNs have a
of national priority. These nine associations such as Association
dual regional and national
include INNs for Digital and for of British HealthTech Industries
perspective – providing a
Medical link into the regional health
Genomics and personalised
medicine. The specific focus for
(ABHI)2 and The British In Vitro
Diagnostic Association (BIVDA)3
and care community and
technology understanding patient
the MedTech INN is therefore
on physical devices and in-
to accelerate the development
of a flourishing market by
needs while also operating
vitro diagnostics, i.e. excluding pulling through successful
as part of a national
the more consumer-focused innovations into mainstream
Engineering Health promotion network. The AHSN licence
digital technologies at one end
was renewed in 2018 use. Potential will be judged
advances and wellness and large devices such as MRI by considering both the
and has increased the
Reducing the size and Extend the scope of scanners at the other. demand and supply sides
emphasis on achieving an
cost of once complex devices, services beyond what of the innovation cycle. It will
making them available is considered medical and impact on the NHS from
Ultimately the AHSN Network include consideration of:
at the point of care, offer some innovations the adoption of innovation.
– through the INN or more
and for consumer a route to less regulated
generally – will seek to • The technology maturity
wellness markets early adopter markets
Digital champion game-changing – what is the scientific
technologies that combine basis of the innovation and
Intelligent devices
connect to networks cutting-edge science from our what more must be done
and provide data for universities and leading clinical to demonstrate a mature
artificial intelligence research from the NHS with solution?
and electronic innovative companies seeking • The degree of innovation –
patient records to grow in England. These are what is the health economic
the innovations with greatest value proposition?
potential to scale and address • The dynamics of adoption
global markets. We will do this – does the technology
by facilitating access for the require a wholesale change
relevant parties to: to care pathways and
reimbursement, or can it
What matters most for our current purposes is the impact that innovations will have on health and • Cutting-edge R&D be deployed into existing
care systems. While a definition such as the above is helpful, it should not be used to discourage • High tech manufacturing advice services?
innovators working at the boundaries with other sectors. Indeed, the MedTech market is evolving • Leading NHS providers • The competitive landscape -
rapidly as convergence enables many innovations to exploit the synergies between traditional sectors, seeking to adopt game- how unique and protectable
as highlighted in the diagram above. changing innovations. is the innovation?8 9
2 The MedTech
industry in England 2,150 84%
53
large companies
companies
The MedTech sector covers a wide range of technologies, serves global markets and accounts for around Companies in the core
are small companies Companies with a turnover of
over £50m include UK companies
40% of Life Sciences employment in England. MedTech (less digital) 1,819 companies employ and inward investment in
sector in England less than 50 people R&D operations by global
Working with the NHS in England offers significant market opportunities for MedTech companies as well MedTech corporations
as a globally respected ecosystem for conducting research and development.
£6bn NHS annual spending on MedTech
86,000 23,000
£3bn £3bn jobs jobs
40% of the total 27% of employment A particular challenge faced
Medical consumables – Complex devices –
life sciences in the sector in developing the sector is
dressings, syringes hip joints, cardiac devices
employment and the gulf in size between the
small number of multi-national
MedTech is a UK-wide 10 segments account for MedTech companies with a
endeavour 75% of employment presence in the UK and the large
number of SMEs and start-ups.
Core MedTech SMEs account
MedTech sector company distribution Core MedTech segments employment for nearly half (47%) of the total
0 1,000 2,000 3,000 4,000 5,000 6,000 7,000 8,000 9,000 number of life sciences SMEs.
Orthopaedic
devices £16.8bn £5.7bn
Single use
technology
Turnover Around a third of
Assistive including the total turnover
technology services comes from small
Hospital companies
hardware
IVD
Distribution technology
of companies Re-usable diagnostic
by postcode equipment
Wound
care
Anaesthetic and
98%
respiratory technology
Ophthalmic
devices / equipment
Medical imaging / SMEs
ultrasound
Sources:
100+ science and Providing facilities for MedTech • PA Consulting analysis of company data from “Strength and Opportunity 2017: life sciences companies data”
published by The Office for Life Sciences
innovation parks companies to grow
• NHS procurement data from “Operational productivity and performance in English NHS acute hospitals:
Unwarranted variations”, an independent report for the Department of Health by Lord Carter of Cole10 11
3 Navigating the 3.1 Creation
innovation pathway Before investing a significant
amount of effort in developing
What outcomes will
the product deliver?
technologies on the health
and care economy, such as an
a MedTech concept, it is increased life expectancy of a
The MedTech landscape is shifting, with challenges in the form of new regulatory requirements, and strong important to understand The health economic case particular patient cohort (and
market forces driving the need for more competitively priced profitable products into a complex and the market in which it will be for the product must also the concomitant increase in
increasingly diverse healthcare procurement landscape. The aim of this section is to navigate developers and placed. Considering the market be extended to take into the duration of care provision)
other interested parties through a MedTech innovation pathway, highlighting key activities to be undertaken at this early stage will avoid consideration impacts of the as a consequence of improved
at each step, and signposting the specialist support potentially available to ensure that new innovations unnecessary investment of technology on outcomes diagnostic capability, are more
achieve both patient benefit and commercial success. time and expense in maturing through the lenses of the difficult to estimate. Patient
technologies that offer limited patient, the user of the involvement in research and
market value. technology and the healthcare development is increasingly
Development Development Evaluation / Commissioning system as a whole. It is a priority for regulators and
Creation
(Prototype) (Trials)
Regulation
reimbursement and adoption What is the market relatively easy to determine other official bodies. Involving
value of the product? the short-term benefits of patients and other relevant
those technologies impacting stakeholders at this early stage
Whether offering a MedTech on patients and providers, e.g. will ensure a holistic view of the
The MedTech innovation pathway solution to the NHS or a private increased speed and accuracy relevance of the final product,
The key activities underpinning each step of the MedTech Innovation pathway are outlined below: healthcare provider and its of procedures, improved identify its value, highlight
patients, its value to the recovery rates, improved any accessibility issues and
market must first be identified. bed utilisation. However, ultimately strengthen the
Identification of market value of concept, impact on outcomes Page Paramount to moving the the longer-term impacts of business case.
Creation
and market access barriers 11 MedTech concept forward is
remembering that it will not be
of worth if nobody wants to buy PICO methodology
Development Development and refinement of product ready for regulatory Page it. Identifying consumer wants
(Prototype) assessment and clinical evaluation 14
and needs, and subsequently Focusing on the problem itself and trying to address it with the
developing the product or technology enables a higher rate of success of getting a product into
service to meet them, is the health and social care system. PICO is a framework methodology
Development Clinical evaluation of product to demonstrate that it is safe Page
(Trials) and performs as intended an initial step that must be employed by NICE when evaluating a MedTech product for the
15
completed before moving onto NHS. Employment of this methodology early on in the innovation
other steps in the process. Will pathway will help validate the potential case for a technology having
Assessment of product to ensure it conforms to the requirements for the Page the MedTech concept deliver a successful entry to the NHS.
Regulation
relevant legislation in each jurisdiction in which the product is to be marketed 17 a product that is novel to the
market, or deliver a product
with technology offering a
Evaluation / Evaluation and endorsement of the health and economic case, Page competitive advantage over Population What population of patients will your
reimbursement clarification of reimbursement approach 19 existing products in the market? technology address?
Will the technology align to
published NHS priorities and/ Indication What does your technology do? How does it work?
Commissioning
Preparation for, and entry to market, development of business case Page How does it solve the problem?
or address an unmet need for
and adoption 22
providers and patients? The Comparator What happens at the moment in the healthcare
NHS Five Year Forward View5 system and how are those patients treated?
and the recently published
The information in this guide relates to the innovation pathway steps and core activities for the MedTech sector. NHS Long-Term Plan provide a Outcome What is the difference between the current
However, in some instances some information is also applicable to other healthcare sectors. The MedTech strong indicator of the focus for therapy and your new technology?
Innovation pathway steps are aligned to published OLS guidance4 NHS investment going forward.
➜12 Navigating the innovation pathway Navigating the innovation pathway 13
What data will be required to enable Innovation Exchanges
UK Research and Patient and user
the NHS to buy? Each AHSN operates an Innovation
Innovation (UKRI) engagement
Exchange which has the potential
It is advisable, at this stage, to understand how healthcare providers in Established in April 2018, to link MedTech solutions with
the target market buy MedTech products. In a climate of significantly UKRI works in partnership existing local healthcare system Patient and user engagement
high cost pressures, and a healthy competitive landscape, market with universities, research challenges, to ensure the local can be accessed through
access for MedTech products is challenging. A convincing health organisations, businesses, needs of the STP and Integrated a range of mechanisms,
economic case, underpinned by supporting clinical data, will be needed charities and the government, Care Systems are met. Funded by including direct engagement
for procurement teams to overlook cheaper competitor products offering a diverse range the OLS, the Innovation Exchanges with NHS Trusts, the AHSNs,
and understand the value of the innovation. NICE endorsement of the of funding opportunities. are able to bring people and through medical charities
product and a vocal stakeholder group will add weight to the case for It enables the fostering of organisations together, speeding and through the NIHR
procurement. We cannot over-stress the importance of understanding international collaborations up the spread of innovation in the national advisory group,
how the NHS determines the costs and benefits of a product in order and offers access to facilities local area, saving the NHS money, INVOLVE. INVOLVE is a large
to inform the buying decision. and infrastructure to support generating economic growth and public participation charity
research and innovation. getting technologies to more aiming to put people at the
Are there any barriers How will this phase Current UKRI funding patients faster. heart of decision making.
opportunities are publicised on INVOLVE ensures the views
to market access? be funded? of patients and the public
its website and are accessed The implementation of innovation
via a competitive process. exchanges varies from region to are incorporated during
In addition to identifying drivers Sourcing investment is almost the research phase of the
for market uptake, it is also wise always one of the first problems www.ukri.org region but see www.ahsnnetwork.
com/innovation/innovation- innovation pathway.
to consider hurdles to market that arises. Many investment www.involve.org.uk
penetration at this stage. These avenues are available at this stage exchange and for example
may include situations where including, but not limited to, seed, www.innovationexchangeeast.org.
Innovate UK
a MedTech product requires a angel, patient capital, venture
change to Government policy capital, research grants, and family Innovate UK is the UK’s NICE Office for Market
for its use, or where additional and friends. The National Institute innovation agency. It drives Knowledge Transfer Network (KTN) Access (NICE OMA)
regulatory assessments are of Health Research (NIHR) is the productivity and economic
required to enable certification largest national clinical research growth by supporting businesses A network partner of Innovate UK, the KTN links innovators with NICE’s Office for Market Access
in the target market. Considering funder in Europe, with a budget to develop and realise the expertise, markets and finance through a network of business, provides expert advice to the life
market hurdles at this point, of over £1 billion, although it potential of new ideas. Innovate universities, funders and investors. The Health KTN provides in-depth sciences industry, helping innovators
will avoid costly issues further concentrates on discovery science UK has a strong business focus knowledge and an established network with the added advantage to understand the impact on their
downstream in the innovation and applied scientific research and funds business and research of being able to connect innovators with peers from other sectors. technology, of initiatives such as
pathway. NICE’s Office for Market rather than on technology per collaborations to accelerate https://ktn-uk.co.uk the Accelerated Access Review
Access (NICE OMA) provides se. UK Research and Innovation innovation and drive business (AAR), and the wider life sciences
expert advice on market access. (UKRI) and its research councils investment into research and strategy. NICE OMA helps navigate
Further information on market also have access to a wide range development. It helps turn ideas the differing approaches to market
access can be found on page 24 of government funding for early into commercially successful access, considering the implications
of this guide. stage research and development. products and services by for the technology offering.
connecting businesses www.nice.org.uk/about/what-
with partners, customers we-do/office-for-market-access
and investors through two
innovation networks - the Industry associations
Knowledge Transfer Network
(KTN) and Enterprise Europe Various industry associations and
Network (EEN). trade bodies e.g. ABHI2, BIVDA3
www.gov.uk/government/ and TechUK6 support the
organisations/innovate-uk innovation of medical technologies
in the UK and the wider EU market.14 Navigating the innovation pathway Navigating the innovation pathway 15
3.2 Development Phase 2: Testing through clinical trials
Whilst the clinical trial protocol for pharmaceutical drugs has long been established, the level of clinical
Once the fundamentals described evaluation required to gain regulatory approval for MedTech products is less well known. The clinical data
here have been defined, a Catapult centres required by the regulators to demonstrate that a MedTech product performs as intended and is safe to use is
MedTech concept can advance dependent on the class of technology (outlined on the Medicines & Healthcare products Agency (MHRA) website)
through to the development Support in the design phase is strengthened by the presence being evaluated7, with higher risk MedTech products requiring more extensive clinical evaluation before they can
for readiness for regulatory of Catapult centres which facilitate UK businesses, scientists be launched onto the market. This is summarised below with an additional look at In Vitro diagnostic devices:
submission and market launch, and engineers to work side by side on late-stage research
depending on the complexity of and development. There are 11 Catapults in total including cell
the innovation and its adoption. and gene therapy, digital, high value manufacturing, medicines In Vitro diagnostic
Medical devices
We have divided this development discovery and precision medicine. medical devices
phase of the innovation pathway www.catapult.org.uk High risk
Examples: Examples:
into two phases: Prototyping and Hepatitis B blood- devices
Pacemakers
testing through clinical trials. Heart valves donor screening Expected level of
Class III Class D HIV blood
Implanted cerebral
Knowledge Transfer NHS Innovation simulators diagnostic test: clinical evaluation
required: Clinical
Phase 1: Prototyping Partnership (KTP) Accelerator (NIA)
ABO blood grouping
investigations
Examples: Examples:
As is well known, development Development of a KTP has been The NIA supports the Bood glucose
Condoms
of product prototypes is an shown to increase profitability update and spread of high Lung ventilators self-testing
Class IIb Class C PSA screening:
iterative process with multiple for business partners as a direct impact, evidence-based Bone fixation plate
HLA typing
versions often tested and result of the partnership through innovations across England’s
refined until a final product is improved quality and operations, NHS, benefiting patients, Low-to-medium
developed to progress to the increased sales and access to new populations and NHS staff.
Examples: Examples: risk devices
Dental fillings Pregnancy
self-testing Expected level of
market. Facilitation of a close markets. The three-way partnership An NHS England initiative, Surgical clamps
Class IIa Class B
Tracheotomy tubes Urine test strips clinical evaluation
working relationship between also includes a qualified graduate delivered in partnership with Cholesterol
Class I medical required: Literature
the engineering team and the who supports the company for AHSNs, it currently supports self-testing
devices will require review and/or
manufacturer during the design the duration of the programme, a significant number of involvement of a Examples: Clinical investigations
Examples:
phase, with a clear focus on the an arrangement which typically ‘Fellows’ representing Notified Body if they Clinical chemistry
Wheelchairs
are sterile, have a analysers
needs of the end user, is critical lasts between 12 and 36 months. over 30 innovations. Stethoscopes Class I measuring function Class A Specimen receptacles:
Spectacles
to delivering a successful viable http://ktp.innovateuk.org www.nhsaccelerator.com or are re-usable Prepared selective
surgical instruments. culture media
end product. This collaboration
builds value into the product and
ensures that the product can be
MedTech classes and level of clinical evaluation required
manufactured in a cost-effective SBRI Healthcare (SBRI)
manner, providing evidence
to support the product’s value Supported by Innovate UK, SBRI Healthcare is a programme 100%
proposition. funded by NHS England which both seeks to improve patient care National Institute of
and drive efficiency of delivery. Through research and development, Health Research (NIHR) MedTech and In Vitro diagnostics
SBRI Healthcare acts as an enabler for the NHS to access new Co-operatives (MICs)
innovations in their early stages of maturity, to help solve identified Known as the ‘research arm of
healthcare challenges and unmet needs. The programme also aims the NHS’, NIHR is a Government The newly-formed NIHR MedTech and In Vitro diagnostics
to support economic growth by boosting wealth creation through body funded to improve the health Co-operatives (MICs) act as a centre of expertise, bringing
the adoption of UK-sourced innovations. The programme has been and wealth of the nation through together patients, clinicians, researchers, commissioners
running since 2013 and has awarded around £10million annually research. It has the infrastructure and industry to support the development and evaluation of
through contracts for development awarded to innovators. and expertise to support early stage MedTech products in a clinical setting. Each MIC has a specific
www.sbrihealthcare.co.uk research and development, and to theme and is hosted by an identified lead NHS organisation8.
identify health and care provider
and patient needs. www.nihr.ac.uk
➜16 Navigating the innovation pathway Navigating the innovation pathway 17
Leeds
NIHR Leeds In Vitro
Diagnostics Co-operative
Newcastle
NIHR Newcastle In Vitro
Diagnostics Co-operative
NICE Scientific Access 3.3 Regulation
(NICE SA)
NIHR Surgical MedTech
Co-operative Sheffield NICE offers a fee-based Changes to regulation for MedTech products
NIHR Devices for Dignity consultancy service to
MedTech Co-operative developers of MedTech, working As implied previously, there are a number of regulatory requirements that must be met before a technology
Nottingham can enter the UK and EU market. Until recently, this conformity was in the form of alignment to one of three
NIHR Children and with innovators during the early
NIHR Mental Health EU Medical Device Directives (MDDs):
MedTech Co-operative Young People MedTech stages of product development
Co-operative to encourage consideration
of relative clinical and cost
Birmingham Cambridge effectiveness of products. NICE-
• The Active Implantable Medical Devices (AIMD) Directive (90/385/EEC)
NIHR Trauma Management NIHR Brain appointed experts support the Directives
MedTech Co-operative Injury MedTech • The In Vitro Diagnostic (IVD) Medical Device Directive (98/79/EC)
development of evidence that (OLD) • The Medical Devices Directive (93/42/EEC)
Co-operative
demonstrates product value and
provide detailed feedback on
London clinical, economic development
NIHR Cardiovascular However, in May 2017, new EU regulations for medical devices were put into force to overcome perceived
MedTech Co-operative and evidence generation plans.
Oxford www.nice.org.uk/about/ flaws and divergences in the existing MDDs, increasing patient safety via a robust, transparent and
NIHR Community Healthcare MedTech NIHR London In Vitro sustainable regulatory ‘fit for purpose’ framework:
and In Vitro Diagnostics Co-operative Diagnostics Co-operative
what-we-do/life-sciences/
scientific-advice
Geographical locations of MICs across England
Contract Research MedTech Early HealthTech Connect Regulations • The Medical Device Regulation (MDR) (2017/745)
(NEW) • In Vitro Diagnostic Medical Device Regulation (IVDR) (2017/746)
Organisations Assessment (META) Tool
HealthTech Connect (previously
Partnership with a Contract Research The META tool is an online service known as MedTechScan), a new
Organisation (CRO) or another that helps medical technology ‘horizon scanning’ database
authorised clinical testing body for developers optimise their of pre-launch phase MedTech EU member states have been given In the UK, regulation of medicines, assessments include the review
the completion of the clinical testing development plans for their medical products, was launched in a 3 to 5-year transition window, medical devices and blood of clinical and scientific data,
of MedTech products will ensure technology. It provides a structured January 2019. The secure online with MDR and IVDR expected to be components for transfusion is manufacturing processes and
that the process is completed to a framework to help identify potential system will replace and unify existing fully implemented by 26 May 2020 overseen by the The Medicines the quality management system.
standard sufficient to meet regulatory gaps in product development sources of MedTech information, and 26 May 2022 respectively9. and Healthcare product Manufacturers can certify their
requirements. Information is available plans and the potential next steps improving the identification and During this transition period, Regulatory Agency (MHRA)10 products with any notified body
through the Clinical and Contract to bring a product to market; tracking of new and emerging MedTech can be placed on the in the EU. The MHRA retains an
Research Association www.ccra.org.uk https://meta.nice.org.uk MedTech in development across market under either the current Conformity up to date list of notified bodies
the UK. Developed by NICE, EU MDDs or the new regulations. assessments for MedTech11.
with NHS England funding, and However, MedTech devices placed
Patient Data for Research supported by local AHSN systems, on the market after the transition Manufacturers need to Most class I medical device and
The landscape for accessing ‘real world’ patient data for both retrospective digital and face-to-face meetings, period will need to fully comply demonstrate that their MedTech Class A in vitro diagnostic devices
and prospective research is changing incredibly quickly. Health Data it will reduce the duplication and with the new regulations, unless meets the requirements in the do not need to pass a conformity
Research UK (HDR UK) is leading the delivery of the Digital Innovation Hubs complexity involved in getting they wish to make use of the MDR or IVDR by carrying out assessment. However, they will
– a UK-wide initiative to enable the safe and responsible use of health- health technology to market in the extended period of CE certificate a conformity assessment. The still need to be registered with
related data at scale for research and innovation. www.hdruk.ac.uk UK. Access to this information will validity. Manufacturers with a conformity assessment route the MHRA.
permit improved NHS planning product already on the market depends on the classification
In the meantime, the Clinical Practice Research Datalink (CPRD) facilitates around introduction and adoption will need to update their technical of the device (and the risk Manufacturers will be issued
observational studies, clinical trial feasibility and protocol optimisation of new technologies and encourage documentation and processes class determines whether or with a CE certificate which can
by making de-identified patient data available from a network of GP early engagement of industry in order to meet the requirements not a conformity assessment be placed on their product to
practices across the UK. www.cprd.com with the NHS. of the new regulations by the is required). Undertaken by show that it has passed the
www.healthtechconnect.org.uk dates above. notified bodies, conformity conformity assessment. ➜18 Navigating the innovation pathway Navigating the innovation pathway 19
Devices class
Obtaining regulation
3.4 Evaluation and reimbursement
Medical In Vitro Notified body
Devices Diagnostic approval required? for products
Medical Devices Once a MedTech product economic case by the National a product’s potential to improve
marketed outside has received a CE mark, the Institute of Health and Care patient outcomes, reduce costs and
I A No
of the EU
Increasing risk
manufacturer is free to sell, lease, Excellence (NICE)19. provide whole system benefits. NICE
IIa B Yes lend or gift the product across helps the NHS to adopt effective and
Manufacturers planning Europe. Although not mandatory, NICE is an executive non- cost-efficient technologies through a
IIb C Yes to launch their product in it is widely accepted that the case departmental public body of the review of evidence and advice from
III D Yes markets outside of the EU for reimbursement of MedTech Department of Health in the UK, experts and patients, leading to
will need to ensure regulatory products in the UK (and wider responsible for providing national the publication of market briefings,
requirements for each of field) is made fundamentally guidance on medicines and MedTech guidance and guidelines relating to
MedTech conformity assessment routes the product destinations are easier through evaluation and products and advice to improve the technologies/topics of interest,
met. The regulatory burden endorsement of the health and health and social care, highlighting as outlined below:
Compliance Post-market monitoring for market access to some
Manufacturers are required to and surveillance countries has been alleviated
have at least one person available by Mutual Recognition
Once a medical device has been placed Agreements (MRAs) between
with responsibility for regulatory in the UK market, the manufacturer
compliance who possesses expert the EU and third-country
is responsible for monitoring the authorities concerning the • Product specific
knowledge in the field of MedTech. product and reporting serious conformity assessment of NICE advice • Condition / population
adverse incidents to the MHRA, to regulated products. These • Summary of key specific
Quality Management ensure the technology is safe to use. clinical evidence NICE guidance
• Systematic review of
trade agreements facilitate
System (QMS) market access through greater
• Summary of existing clinical evidence
Custom-made devices economic models • Key areas prioritised
harmonisation of compliance (if available) • Product specific for economic modelling
Companies submitting a MedTech
standards, and reduced need • No recommendations • Systematic review of • Recommendations
product for regulatory approval in NHS organisations often produce clinical and cost evidence
the UK will need to demonstrate diagnostic tests in-house or modify for duplicated inspections unlikely to be product
• De novo economic modelling specific
alignment to the ISO Standard MedTech to allow clinical teams upon importation of products.
• Product specific
1348512 and other applicable to respond rapidly to new or The EU has MRAs with United MedTech
recommendations
States, Australia, Canada, Innovation Briefing
standards. This is facilitated by the emerging threats, and to promote
development of a QMS, a repository the development of more innovative Israel, Japan, New Zealand NICE guideline
of business processes, policies, solutions through collaboration by and Switzerland16.
documented information and medical researchers with peers.
resources relating to the development Guidance on compliance requirements
and manufacture and procurement for custom-made devices can be found MedTech and Brexit MedTech product journey through the NICE evaluation pathway
of the MedTech product. on the UK Government website15
At the time of writing this guide, the
regulations governing MedTech in The NICE evaluation Research Innovation Observatory be produced. NICE will only
Traceability the UK were under consideration in (NIHRIO) which identify review technologies which have
light of the planned departure of the process technologies likely to have the a CE mark or equivalent, or if it
Manufacturers complying with the new regulations will be required to UK from the EU. Further information most benefit to patients and the is expected within one year.
assign a Unique Device Indentification (UDI) to the label and/or packaging of on the implications of Brexit on the NICE is informed of new health and social care system.
their product to enable traceability within the global market, improving the UK MedTech industry can be found medical technologies requiring If selected, the topic oversight
effectiveness of the post-market safety of MedTech products and security in the MedTech Europe position evaluation, either through Notified MedTech products are group route the product through
of the supply chain13. Manufacturers will also be requried to register their paper17. Contingency planning notification from a sponsor initially assessed by the NICE one of three NICE programmes
organisation and technology, upload relevant information, apply for clinical guidance for the event of a no-deal (manufacturer, clinician, patient topic oversight group, who for full assessment to ensure that
investigations and performance studies, and upload post-market surveillance Brexit has been developed by or other interested party) or determine if a topic briefing on guidance is appropriate for the
documentation to the European databank on medical devices (Eudamed)14. the Government and shared with through sources (for example, the technology and/or MedTech value proposition offered by the
MedTech manufacturers18. the National Institute for Health Innovation Briefing (MIB) should technology and evidence available. ➜20 Navigating the innovation pathway Navigating the innovation pathway 21
MedTech products likely to result in an overall increase in resource costs to health and social care are routed UK local NHS UK National NHS
through either the Technology Appraisal Programme (TAP) or Diagnostics Assessment Programme (DAP), whilst Product reimbursement reimbursement
those products likely to deliver a cost saving or to be cost neutral are routed through the Medical Technologies reimbursement
Evaluation Programme (MTEP). An overview of the NICE evaluation programmes is shown below: CCGs are clinically-led statutory Some devices associated with
One of the most common NHS bodies responsible for the specialised services are reimbursed
Clinical performance Better Non-inferior mistakes made by companies planning and commissioning by NHS England at a national
is the assumption that, of healthcare services in their level with a funding mandate
Cost Higher Less overall by assigning a price and local area. Responsible for for specialised commissioners.
successfully gaining market approximately two thirds of the Classification of a product for
Evaluation method Cost effectiveness (QALY) Cost consequences entry, a product will be bought total NHS England budget, CCGs specialised commissioning is
with the structure of the exert a significant influence over determined by the following factors:
NICE guidance Technology Diagnostics Medical Technologies reimbursement system of the prescribing and reimbursement
programme Appraisals Assessment Evaluation Programme that country. It is imperative of MedTech products for use • The number of individuals who
Programme Programme (MTEP) to consider a product’s by their population. require the product (less than
(TAP) (DAP) pricing strategy, reflecting the 500 nationally);
different market drivers and NICE- approved products are not • The cost of providing the
Technologies
✔ Devices ✔ Diagnostics ✔ Devices reimbursement policies at this reimbursed until individual CCGs product and/or associated
✔ Diagnostics stage of the process to ensure grant access to the product in service for use;
the attractiveness of product their region. NHS funding and • The number of people able
NICE evaluation programmes for MedTech products in the market and maximal reimbursement for products to provide the service;
market update. recommended by the NICE • The financial implications for
NICE assesses a product on both allow consideration of unpublished Technology Appraisal Programme, CCGs if they were required to
a benefits and cost basis: as well as published information. The MedTech To understand how however, is obligatory within arrange for provision of the
outcome of the EAC assessment is reimbursement works, it is three months of guidance being product and service themselves.
• How well does the technology collated into a report which is reviewed Innovation Briefings important to understand how published. Typically, CCGs will
work compared to standard by the Medical Technologies Advisory (MIBs) the money flows. In the UK, go to tender to select formulary Products are evaluated on clinical
practice in the NHS? Committee (MTAC). The Committee, MedTech manufacturers sell devices. Progressively CCGs are effectiveness, finance and activity
• How much does this course of comprising of clinicians who develop Commissioned by NHS their products broadly through forming larger regional decision- impact assessments, prior to public
action cost compared to standard and use MedTech, scientists and England, MIBs provide three channels: making groups for evaluating consultation and final decision by
practice in the NHS? people providing a lay perspective evidence-based advice devices for inclusion on formulary, NHS England. Further information
on health and social care issues, to those considering the • Directly to patients (private and for devices which are used in on this process can be found on
External Assessment Centres (EAC) is responsible for making the final implementation of new sale, prescriptions); both hospital and out of hospital. the NHS England website20.
are employed by NICE to critique decision on NICE recommendations medical devices or diagnostic • To an NHS or private
the submission and undertake for use of MedTech products. Draft technologies. By making this healthcare provider to use in
any further technical evaluations. guidance recommendations are information available, NICE the secondary care services,
Recognising the limited evidence subject to public consultation before helps to avoid the need for either directly, through
base available for MedTech products, being finalised and published on NHS organisations to produce wholesalers or the NHS
a permissive approach is adopted to the NICE website. similar information for local Supply Chain;
use. MIBs are designed to be • To a company who uses
fast, flexible and responsive the MedTech product in the
The National Institute for Health Research to the need for timely delivery of their service to
Innovation Observatory (NIHRIO) information on innovative a healthcare provider.
technologies.
The National Institute for Health Research Innovation Observatory, hosted
by the University of Newcastle, undertakes ‘horizon scanning’ identifying See www.nice.org.uk/about/
topics and aims to inform NICE of new MedTech early in development to what-we-do/our-programmes/
enable NICE to publish guidance as close as possible to product launch. nice-advice/medtech-
www.io.nihr.ac.uk innovation-briefings22 Navigating the innovation pathway Navigating the innovation pathway 23
3.5 Commissioning and adoption Category towers
Intelligent client £
Tower 1 Ward Based Consumables
coordinator
The NHS supply chain Transformation and re-procurement • Using increased buying power Tower 2 Sterile Interventions Equipment
of the NHS Supply Chain is to affect purchasing behaviours 11 Procurement and Associated Consumables
The NHS Supply Chain has a expected to achieve significant and deliver the best products category towers Tower 3 Infection Control and Wound Care
new operating model (herein benefits for the NHS through: at the best value for the NHS. Logistics
Tower 4 Orthopaedics, Trauma and Spine,
referred to as the ‘NHS Supply Ophthalmology
Chain’) that has been introduced • Increasing uptake/volume of Currently only 40% of the NHS’s Tower 5 Rehabilitation Disable Services, Women’s
to deliver improved procurement products purchased via the £6bn spend on everyday hospital Health and Associated Consumables
and logistics support to the national route to market in consumables, common goods, high
Tower 6 Cardio-Vascular, Radiology, Audiology
NHS. In a strategic response order to aggregate national value healthcare consumables and
and Pain Management
to the findings outlined in the demand, and secure value capital equipment goes through NHS
Carter report, the new operating for money for the NHS Supply Chain. Implementation of the Tower 7 Large Diagnostic Capital Devices
Transactional including Mobile and Consumables
model will enhance procurement and taxpayers; new operating model is expected
efficiency and effectiveness • Increasing use by the NHS of to double this to 80%, releasing services Tower 8 Diagnostic Equipment and
across the NHS, delivering a standard range of clinically an estimated £2.4bn of savings Associated Consumables
clinically safe, high quality appropriate products to reduce in its first five years of operation, Tower 9 Office Supplies
Supporting technology
products for the best unwarranted variation in the which can be used by the NHS for Tower 10 Food
infrastructure
possible value. system; and reinvestment in front line services. Tower 11 NHS Hotel Services
NHS supply chain procurement category towers
Fourteen separate contracts have Commissioning of The new operating model is expected
10% been awarded to service providers MedTech products to promote a number of opportunities
that will manage the Category for suppliers when selling to the NHS:
20% 10% Towers, and the procurement of through the new
40% 80% logistics, transactional services operating model • Aggregation of demand could offer
and IT services for the NHS for suppliers larger volume opportunities
40% a three-year period. Oversight There are six main routes to than the current NHS Supply Chain;
and operational management of market for companies interested • Lowered sales and marketing
the new contracts and services in supplying their MedTech costs by reducing the number of
along with customer engagement product directly to the NHS: interactions with Trust procurement
activities will be delivered by the teams, as the NHS Supply Chain
management function of the • Selling direct to trusts or can act as a single point of contact
NHS Supply Chain, The intelligent primary care organisations; for supplying into the NHS;
Client Coordinator. • Selling through the new NHS • Clinical assurance that products are
Hubs Hubs Supply Chain; being procured on the basis of user
NHS Supply Chain NHS Supply Chain The NHS Supply Chain will be • Selling through collaborative requirements, not simply unit price;
Trust Procurement Teams (200+) Trust Procurement Teams centrally funded from 1 April 2019, purchasing arrangements; • Sales commitment making
where the price of goods will • National framework business and production planning
be passed onto Trusts with collaborations and contracts; easier for suppliers;
Changes to the NHS procurement landscape no additional margin. • Government tenders and • CTSP incentivisation to reduce
contracts; total cost in the system, not just
The procurement function of the NHS Supply Chain is managed through 11 Category Towers. These towers are • Selling to a company which reduce unit price; and
operated by a Category Tower Service Provider (CTSP) who has specialist knowledge of that product category to then uses the MedTech product • A streamlined procurement
enable them to undertake the clinical evaluation of products, run compliant procurement processes on behalf of the in the delivery of their service landscape will reduce the burden
NHS and create strategies that sustainably provide the NHS with clinically assured products that drive the best value. to an NHS provider. of multiple tenders. ➜24 Navigating the innovation pathway Navigating the innovation pathway 25
Increasing market This set of consequences is likely to The role of the AHSNs
be true of the most disruptive – and Case study: optometrists and podiatry clinics
adoption of innovative hence potentially the most beneficial in supporting market Normal Sinus Rhythm
Atrial Fibrillation - Regular Wave Pattern and ‘Safe and Well’ checks
MedTech products innovations. adoption and diffusion carried out by the fire service.
Uniform Distance
Atrial Fibrillation (AF) is an Since January 2018, all 15
MedTech innovators often refer to The challenge of getting MedTech The importance of AHSNs in the irregular heart rhythm that AHSNs have been distributing
a ‘Valley of Death’. This is part of products to market in a timely manner successful spread of innovations causes one in five strokes. AF over 6,000 of these devices (of
the pathway where products have has been nationally acknowledged has been documented in a is often asymptomatic and can five different types) to primary
been developed but take anywhere with the recent publication of the recent King’s Fund study23, and is occur intermittently, which makes and community care settings
between 5 and 10 years to navigate Accelerated Access Review by the highlighted in the following case diagnosing it a challenge. in order to understand how
regulation, endorsement and Office for Life Sciences22. Since study. Whilst roll-out is still ongoing, It is estimated that 400,000 best to diffuse and encourage
procurement hurdles before they then, NHS England has invested this case study illustrates the people in England are unaware adoption of this technology at
have the opportunity to generate in MedTech-specific procurement impact of how technology needs that they have the condition. scale. Evidence suggests that,
significant revenues. The timeframes initiatives which aim to simplify and to be incorporated into a much Furthermore, there are currently Atrial Fibrillation for primary prevention of stroke
are often longer than typical speed up adoption of particular wider service redesign in order to in excess of 140,000 people - Irregular Wave Pattern in AF patients, about 25 strokes
investors are prepared to wait for groups of MedTech products. These demonstrate lasting impact on who have a confirmed diagnosis and about 12 disabling or fatal
Irregular Distance
returns. Successful navigation of include the High-Cost Tariff-Excluded healthcare outcomes. of AF and hence are at risk of strokes would be prevented
these hurdles does not automatically Devices (HCTEDs)20 and Innovation stroke, who are not receiving yearly for every 1,000 AF patients
guarantee market adoption. and Technology Payment (ITP)21 Healthcare teams using a new anticoagulation therapy. This given OACs.1
Innovators need to achieve replication programmes. Whilst these initiatives MedTech product will often need would reduce their chance of
at scale to exploit the full potential are encouraging, they are only to adapt their existing ways of experiencing a stroke by at least AF is detected in primary care Although the introduction of the
of a product, requiring a significant relevant to a small percentage working, develop new skills and one third, depending on whether and to give rise to significant mobile ECG devices has provided
investment of time, skill, resource of MedTech products. potentially change their culture or they are already taking either reductions in the incidence a valuable contribution to the
and finances, with the innovation build new relationships to ensure aspirin or another anti-platelet of strokes through better number of people being diagnosed
itself sometimes undergoing CTSPs will be designing category optimal use of the technology in drug, or not on medication. detection and treatment. The AF with AF, their health outcomes will
substantial revision and refinement in strategies through engaging with their organisation. There is work programme is one of the seven not change and strokes will not
the process. the market and horizon scanning to be done to support market The traditional method of two-year programmes being be avoided unless individuals with
upcoming innovative products. adoption through the development of detecting AF is with manual rolled out nationally by all 15 newly identified AF at risk of stroke
A recent report by the Health Manufacturers of innovative MedTech standardised User Guides/Standard pulse palpation. However, the AHSNs on the basis of research are prescribed anticoagulation
Foundation highlights the products that can demonstrate Operating Procedures for prioritised effectiveness of this can be which showed the benefits of therapy and are supported
complexities of replicating even proven whole system value to the innovations that can be used at a limited, as it does not detect all anti-coagulation. The programme with long-term adherence. The
simple, well-designed innovations NHS will be able to discuss these local level by healthcare providers cases of AF and many patients is an excellent example of proven mobile ECG devices are therefore
between sites21. More often than with the relevant CTSP. to support implementation, thus with an irregular pulse on mobile technology, strong only a small part of the much
not, successful market diffusion of reducing duplication of effort palpation do not in fact have AF. national commissioning and a wider pathway change that is
innovations requires the design of The NHS Supply Chain is designed across organisations. The diagnosis is then confirmed national implementation pathway, required in AF stroke prevention.
programmes to spread them in more to provide the infrastructure for using a 12-lead ECG. Given that which is being rolled out with Notwithstanding this (and the
sophisticated ways. This is particularly adoption of transformative products The AHSN Network will maintain manual pulse palpation is not local variation where necessary. programme is still underway),
important for those complex through its customer engagement a view of MedTech adoption and 100% effective, this can lead it is an excellent example of the
innovations that lead to a domino function. Working with the AHSNs diffusion nationally, by tracking to unnecessary 12-lead ECGs The mobile technology is a effectivess of new technology
effect, triggering a series of changes and the Accelerated Access Review update of products by individual being undertaken. portable or pocket-sized ECG being implemented in tandem
to diagnosis, treatment and the roles programme, NHS Supply Chain has healthcare providers. device which enables a pulse with awareness campaigns
of staff and patients and revealing been exploring ways in which it can However, this is an area where rhythm check for AF to become and changes to the clinical
new patient needs, all of which help with the early stages of the the introduction of new mobile an everyday part of patient pathway, resulting in improved
impact on the wider health system. innovation pathway. technology, followed by a assessments in a variety of health outcomes.
clearly-defined anti-coagulation settings where it may not have
pathway, is starting to been considered previously; for 1
https://www.ncbi.nlm.nih.gov/
revolutionise the way in which example, community pharmacies, pubmed/16034869
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