HEALTHTECH LANDSCAPE OVERVIEW - MAKING SENSE OF THE MEDTECH INNOVATION MAZE - EASTERN AHSN
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HealthTech landscape overview Making sense of the MedTech innovation maze
2 3
Contents
Foreword 4
Introduction 6
What is MedTech? 8
The MedTech industry in England 10
Navigating the MedTech innovation pathway 14
Identifying and developing regional strengths 42
Achieving growth 46
About the AHSN Network & The MedTech initiative 52
Acknowledgements 54
References 56
4 Foreword 5
Foreword
The Secretary of State for Health UK’s economic growth. It is now require greater collaboration and the NHS Innovation Accelerator • Health Data Research UK Innovation in the HealthTech
has spoken at length about his the largest employer in the an easier exchange of information – to identify the innovations with (HDR UK) brings together 22 space is often hindered by the
vision for a more technology- broader UK Life Sciences sector, between clinicians and patients. the biggest potential impact research institutes across the complex and dynamic wider
driven NHS and the benefits that employing 127,400 people in 3,860 This is a complex journey and we if scaled nationally. UK in a one-institute approach healthcare system, which can
this approach will bring. We are companies, with a combined are still in early stages. • The Accelerated Access to ensure large scale data and be difficult to navigate. For
at the early stages of technology turnover of £24bn. New HealthTech Collaborative (AAC) has advanced analytics benefits this reason, I am delighted to
adoption at scale in the NHS but innovations are coming to market Given our universal single-payer established a new dedicated every patient interaction, clinical introduce this practical guide
the NHS Long-Term Plan has made daily. Some of these, such as system, and our complete national unit within NHS England and trial, biomedical discovery and which sets out the MedTech
it clear that innovation in general, blood pressure monitors, activity datasets, the UK would appear NHS Improvement to promote enhance public. innovation pathway, providing
and technological innovation in monitors and blood glucose uniquely placed to play a leading cross-sector partnerships • Digital Innovation Hubs are innovators from the UK and
particular, are fundamental to the monitors, are aimed directly at the role globally in setting the way in accelerating access to being established, involving wider afield a step by step
goal of delivering improvements consumer for disease prevention, in best practice deployment transformative HealthTech. representatives from academia, practical guide for launching
in clinical outcomes patient care management and fitness of innovations in HealthTech. The AAC is currently supporting industry, patient groups, products in the UK market
experience, whilst responding tracking. Others, such as the use We have already put in place the development of 12 exciting research and the NHS to exploit and a more informed view
to the significant budgetary and of AI in radiology and pathology, several collaborations to harness new HealthTech products that the potential of anonymised of the UK MedTech ecosystem.
workforce pressures faced by are aimed at healthcare HealthTech advancements to will meet the needs of targeted clinical data for driving research
health and care systems the professionals and have the achieve our aims: patient cohorts and innovation.
world over. potential to enable faster and • The Life Sciences Industrial
more informed disease diagnosis • Academic Health Science Strategy, published in August A collaborative approach
One of our the UK government’s and precision treatments. Networks (AHSNs), established 2017, engaged industry, the is important as we bring
first steps towards achieving in 2013, form a key innovation third sector and the NHS to together expertise from various
this vision has been to create an HealthTech is fast evolving to arm of our healthcare system, publish a vision and strategy stakeholders across the healthcare
Accelerated Access Collaborative meet the changing needs and bridging gaps and strengthening for the life sciences sector, ecosystem. No single body
(AAC), which brings industry, expectations of the public. the connections between which includes collaboration has the ability to capitalise
government and the NHS together Consumers are seizing the research, life sciences industry with industry and facilitates alone on technology to deliver
to remove barriers to the uptake opportunity to become more and healthcare systems. better care for patients through healthcare for the future. We will
of innovations in health and empowered to take control of AHSNs also work with many better adoption of innovative continue to pursue and promote
technology (HealthTech), so their own health needs and national bodies including the treatments and technologies. collaborations across government,
that NHS patients have faster there is a growing policy shift Association of British HealthTech • The UK Government has industry, academia, charities,
access to innovations that can towards wellbeing and disease Industries (ABHI), Association partnered with industry to set patient groups and the wider
transform care. prevention. Treatments for many of the British Pharmaceutical out a series of life Sciences NHS. We will continue to explore
illnesses are now becoming Industry (ABPI), British In Sector Deals to help ensure all avenues of opportunity to
HealthTech spans across personalised thanks to advances in Vitro Diagnostics Association that pioneering treatments harness HealthTech to transform
the continuum of wellbeing, genomic medicine and long-term (BIVDA) and the BioIndustry and medical technologies are healthcare and to ultimately,
disease prevention, diagnosis, maintenance programmes for Association (BIA). AHSNs have produced in the UK, improving bring about better health
treatment and maintenance. chronic conditions are frequently also developed systems – patient lives and driving outcomes and lead the way Piers Ricketts, Chair, AHSN
It plays a significant role in the available. All these developments notably SBRI Healthcare and economic growth. in ensuring healthier lives. Network and CEO, Eastern AHSN
6 Introduction 7
HealthTech is defined by the
World Health Organisation
(WHO) as ‘the application of The review is split into
organised knowledge and
skills in the form of devices,
five main sections:
Introduction
medicines, vaccines, procedures
and systems developed to solve What do we mean by MedTech?
a health problem and improve 1 A description of how MedTech
quality of lives’. This umbrella is defined
term incorporates a diverse
range of products ranging from
An overview of the MedTech industry
over the counter consumer
devices for health monitoring 2 in England, outlining sector distribution,
turnover and employment
(e.g. smart phone apps,
pregnancy testing) to complex
robotic surgical systems A step by step guide to navigating the
MedTech innovation pathway, outlining
used by specialist clinicians.
HealthTech spans across the
3 key organisations and bodies that can
support innovators during the process
entire health continuum of
disease prevention, diagnosis,
treatment and maintenance An overview of MedTech regional strengths
incorporating a number of 4 across England, focusing on established
and emerging clusters of innovation
industrial sectors including
MedTech, digital, Artificial
Intelligence, Robotic Process An overview of routes to achieving growth,
Automation, and consumer
health, with recent advances
5 and a selection of case studies of companies
that have successfully navigated the
MedTech innovation pathway
often sitting at areas of
convergence between
different clinical disciplines
and between industries.
The sheer diversity of the step to demystify this maze pathway, signposting some
HealthTech sector, means by providing an in-depth how key organisations who can
that while there are common to guide for innovators in the support innovators in their
aspects to the innovation MedTech space. endeavours. It also sets out
pathway, the journey for some case studies, which
innovators in this space It incorporates an in-depth bring to life how MedTech
remain somewhat a puzzle, view of the UK’s MedTech innovations are being
with ambiguity around ecosystem and provides a harnessed and implemented
actions and approvals practical comprehensive within the UK healthcare
required in order to bring guide for innovators system to bring about
their products to market. attempting to navigate patient benefits and
This report takes the first the MedTech innovation health outcomes.
8 What is MedTech? 9
The MedTech sector Fresh opportunities are opening Companies within the MedTech
comprises businesses up in the MedTech sector sector can be broadly classified
developing, manufacturing driven by the growing need for into two groups:
and selling medical healthcare systems to deliver
technologies, supported greater value and fuelled by
What is
by an extensive network advances in science and the Core
of service and supply convergence of technologies.
businesses2. The sector sits Healthcare systems globally MedTech
within life sciences alongside are looking for solutions
MedTech?
biotech and is characterised that enable earlier diagnosis Includes all businesses whose
in particular by the influence of disease, new precision primary business falls under
of medical device regulations treatments and improved developing and producing
and by the health economic patient experience, such as the their own MedTech products.
considerations that impact ability to take high quality care
on adoption and diffusion in closer to home, enabling patient Core MedTech accounts
key customer groups such empowerment. Significant for 70% of the companies
as the NHS. trends in recent years include and 80% of the turnover
the evolution of drug-device in the MedTech sector
Medical technologies are products, (excluding digital).
It is estimated that there combinations, the convergence
services or solutions used to save are more than 500,000 of digital and medical
and improve people’s lives1 different MedTech technologies in connected
products on the market, medical devices, especially
available in hospitals, in the in new forms of diagnostic MedTech
community-care setting
and in patients’ homes.
testing, the application of
artificial intelligence, and the
Service and
MedTech crosses all parts of emerging fields of precision Supply
the care pathway including and regenerative medicine.
prevention, diagnosis, Scientific advances such as Includes Contract Research
monitoring, treatment and nanotechnology and robotics and Manufacturing
care. The product range is are also opening up new Organisations, suppliers of
vast, ranging from sticking possibilities. Medicine is moving consumables and reagents,
plasters, to wheelchairs, towards a more preventative providers of specialist legal
to total body scanners to approach, and MedTech plays and regulatory expertise,
joint replacements. a crucial role in this. medical device design,
analytical, IT, recruitment and
logistics services as well as
finance businesses specialising
in MedTech investments.
10 The MedTech industry in England 11
£6bn NHS annual spending on MedTech
£3bn £3bn
The MedTech
industry
Medical consumables – Complex devices –
dressings, syringes hip joints, cardiac devices
MedTech is a national 10 segments account for
in England
endeavour 75% of employment
MedTech sector company Core MedTech segments
distribution employment
The MedTech sector covers a wide range of 0 1,000 2,000 3,000 4,000 5,000 6,000 7,000 8,000 9,000
technologies, serves global markets and accounts Orthopaedic
devices
for around 40% of Life Sciences employment Single use
technology
in England. Assistive
technology
Hospital
hardware
Working with the NHS in England offers significant Distribution
IVD
technology
market opportunities for MedTech companies of companies Re-usable diagnostic
by postcode
as well as a globally respected ecosystem equipment
Wound
for conducting research and development. care
Anaesthetic and
respiratory technology
Ophthalmic
devices / equipment
Medical imaging /
ultrasound
100+ science and Providing facilities for MedTech
innovation parks companies to grow
12 The MedTech industry in England 13
2,150 86,000 £16.8bn 13,000+
companies jobs
Companies in the core 40% of the total Turnover MedTech patents filed
MedTech (less digital) life sciences including services with the European Patient
sector in England employment Office in 2017
Less than
23,000 3%
98% jobs
of the MedTech companies
SMEs 27% of employment across England have
in the sector a turnover of
over £50m
84% £5.7bn
are small companies Around a third of the
1,819 companies total turnover
employ less than comes from small
50 people companies
Sources:
• PA Consulting analysis of company data from “Strength and Opportunity 2017: life sciences companies data”
published by The Office for Life Sciences
• 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 Cole
14 Navigating the innovation pathway 15
The MedTech innovation pathway
The innovation pathway for MedTech products is formed of 6 steps:
Development Development Evaluation / Commissioning
Creation (Clinical Regulation
(Prototype) reimbursement and adoption
evaluation)
Navigating The aim of this section is to navigate developers and other interested parties through a MedTech
innovation pathway, highlighting key activities to be undertaken at each step, and signposting the
specialist support potentially available to ensure that new innovations achieve both patient benefit
the innovation
and commercial success.
The key activities underpinning each step of the MedTech Innovation pathway are outlined below:
pathway Creation
Development
Identification of market value of concept, impact on outcomes
and market access barriers
Development and refinement of product ready for regulatory
Page
16
Page
(Prototype) assessment and clinical evaluation 21
The MedTech landscape is shifting, with challenges in Development Clinical evaluation of product to demonstrate that it is safe Page
the form of new regulatory requirements, and strong (Clinical and performs as intended 22
evaluation)
market forces driving the need for more competitively
priced profitable products into a complex and
Assessment of product to ensure it conforms to the requirements for the Page
increasingly diverse healthcare procurement landscape. Regulation
relevant legislation in each jurisdiction in which the product is to be marketed 25
Evaluation / Evaluation and endorsement of the health and economic case, Page
reimbursement clarification of reimbursement approach 28
Commissioning
Preparation for, and entry to market, development of business case Page
and adoption 34
The information in this guide relates to the innovation pathway steps and core activities for the
MedTech sector. However, in some instances some information is also applicable to other healthcare
sectors. The MedTech Innovation pathway steps are aligned to published OLS guidance3.
16 Navigating the innovation pathway 17
Creation
It is important to consider
the MedTech market at an
early stage of development to
Q: What outcomes
will the product
deliver?
However, the longer-term
impacts of technologies on the
health and care economy, such
Q: What data will
be required to
enable the NHS
products and understand the
value of the innovation. NICE
endorsement of the product
its use, or where additional
regulatory assessments
are required to enable
avoid unnecessary investment as an increased life expectancy and a vocal stakeholder certification in the target
to buy?
A:
of time and expense for of a particular patient cohort group will add weight to the market. Consideration at this
The economic case
innovators in maturing (and the concomitant increase case for procurement. point will avoid costly issues
for the product must
technologies that offer in the duration and cost of care
A: It is advisable, at this further downstream in the
Q:
also be extended to take into
limited market value. provision) as a consequence of stage, to understand Are there any innovation pathway. NICE’s
consideration impacts of the
improved diagnostic capability, how healthcare providers Office for Market Access
Q: What is the technology on outcomes through
are more difficult to estimate. in the target market buy barriers to (NICE OMA) provides expert
the lenses of the patient, the Patient involvement in research MedTech products. In a market access? advice on market access.
market value user of the technology and and development is increasingly climate of significantly high Further information on
of the product?
A:
the health and care system a priority for regulators and other cost pressures, and a healthy In addition to market access can be found
as a whole. It is relatively easy
A: Identifying consumer official bodies. Involving patients competitive landscape, identifying drivers in later sections of this guide.
to determine the short-term and other relevant stakeholders market access for MedTech for market uptake, it is also
wants and needs, and
benefits of those technologies at this early stage will ensure products is challenging. A wise to consider hurdles to
subsequently developing the
impacting on patients and a holistic view of the relevance convincing economic case, market penetration at this
product or service to meet
providers, e.g. increased speed of the final product, identify its underpinned by supporting stage. These may include
them, is an initial step that
and accuracy of procedures, value, highlight any accessibility clinical data, will be needed situations where a MedTech
must be completed before
moving onto other steps in improved recovery rates, issues and ultimately strengthen for procurement teams to product requires a change
the process. improved bed utilisation. the business case. overlook cheaper competitor to Government policy for
• Will the MedTech concept
deliver a product that is
novel to the market, or Patient PICO methodology NICE Office for
deliver a product with
technology offering a and user Focusing on the problem itself and trying to address it with the Market Access
competitive advantage engagement technology enables a higher rate of success of getting a product into (NICE OMA)
over existing products the health and social care system. PICO is a framework methodology
in the market? Patient and user employed by National Institute for Health and Care Excellence (NICE) NICE OMA7 provides expert
can be accessed to evaluate a MedTech product for the NHS. Employment of this advice to the life sciences
• Will the existing technology through a range of methodology early on in the innovation pathway will help validate the industry, helping innovators
align to published NHS mechanisms, including potential case for a technology having a successful entry to the NHS. to understand the impact
priorities and/or address an direct engagement with on their technology, of
unmet need for providers NHS Trusts, the AHSNs, programmes such as the
and patients? The NHS Five through medical charities Population What population of patients will your AAC, and the wider life
Year Forward View4 and and through the NIHR national technology address? sciences strategy. NICE
OMA helps navigate the
the recently published NHS advisory group, INVOLVE6. Indication What does your technology do? How does it work? differing approaches to
Long-Term Plan5 provide a INVOLVE is a large public participation How does it solve the problem?
strong indicator of the focus charity aiming to put people at the heart market access, considering
for NHS investment going of decision making. INVOLVE ensures the views of patients Comparator What happens at the moment in the healthcare the implications for the
forward, highlighting where and the public are incorporated during the research phase system and how are those patients treated? technology offering.
innovators need to match of the innovation pathway. www.nice.org.uk/about/
the value of their products. www.involve.org.uk Outcome What is the difference between the current what-we-do/office-for-
therapy and your new technology? market-access
18 Navigating the innovation pathway 19
Q: How will this
phase be funded? Q: What opportunities
are there to
collaborate at
Innovate UK
A: Sourcing investment is Innovate UK10 is the UK’s innovation agency. It drives productivity
almost always one of this stage? and economic growth by supporting businesses to develop and
the first challenges that arises. realise the potential of new ideas. Innovate UK has a strong
Many investment avenues
are available at this stage A: A number of organisations
and national programmes
are in place to support
business focus and funds business and research collaborations to
accelerate innovation and drive business investment into research
and development. It helps turn ideas into commercially successful
including, but not limited to,
seed, angel, patient capital, innovators in their networking products and services by connecting businesses with partners,
venture capital, research with potential customers, customers and investors through two innovation networks -
grants, and family and friends. partners and investors, driving the Knowledge Transfer Network (KTN) and Enterprise Europe
UK Research and innovation collaboration at this early Network (EEN).
The National Institute of Health stage of innovation. These www.gov.uk/government/organisations/innovate-uk
Research (NIHR)9 is the largest include Innovate UK10 and its
national clinical research network partner, the Knowledge
Transfer Network (KTN)11, Knowledge Transfer Network (KTN)
funder in Europe, with a
budget of over £1 billion, and the newly launched NIHR A network partner of Innovate UK, the KTN11 links innovators with
although it concentrates on Applied Research Collaborations expertise, markets and finance through a network of business,
discovery science and applied (ARCs)14. In addition to these universities, funders and investors. The Health KTN provides
scientific research rather national initiatives, the AHSN in-depth knowledge and an established network with the added
than on technology per se. network operate local innovation advantage of being able to connect innovators in this space
UK Research and Innovation exchanges which support the with peers from other sectors.
(UKRI)8 and its research development of HealthTech https://ktn-uk.co.uk
councils also have access to solutions to meet specific local
a wide range of government health and care challenges,
funding for early stage ensuring the needs of the local Knowledge Transfer Partnership (KTP)
research and development. community are met.
Development of a KTP12 has been shown to increase profitability
for business partners as a direct result of the partnership through
improved quality and operations, increased sales and access
UK Research and Innovation (UKRI) National Institute of Health to new markets. The three-way partnership also includes a
Established in April 2018, UKRI works in partnership Research (NIHR) qualified graduate who supports the company for the duration
with universities, research organisations, businesses, of the programme, an arrangement which typically lasts
charities and the government, offering a diverse Known as the ‘research arm of the NHS’, NIHR is a between 12 and 36 months.
range of funding opportunities. It enables the Government body funded to improve the health http://ktp.innovateuk.org
fostering of international collaborations and offers and wealth of the nation through research. It has
access to facilities and infrastructure to support the infrastructure and expertise to support early
research and innovation. Current UKRI funding stage research and development, and to identify
opportunities are publicised on its website and health and care provider and patient needs.
are accessed via a competitive process. www.nihr.ac.uk9
www.ukri.org820 Navigating the innovation pathway 21
Development (Prototype)
Once the value proposition and other fundamentals have been defined, a MedTech concept can
Innovation advance through to product development in readiness for regulatory submission and market launch.
Exchanges The development step of the innovation pathway is formed of two phases: Prototyping and testing
through clinical trials
The AHSN Network operates
Q:
innovation exchanges13 to How is a MedTech prototype
link ideas with existing local
healthcare system challenges, product developed?
to ensure the local needs
of the Sustainability and
Transformation Partnership A: Development of a product prototype is an iterative process with multiple versions often
developed, refined and tested until a final ‘market ready’ product is developed. Facilitation
of a close working relationship between the engineering team and the manufacturer during the
(STP) and Integrated Care
Systems are met. Funded by design phase, with a clear focus on the needs of the end user, is critical to delivering a successful
the Office for Life Sciences viable end product. This collaboration builds value into the product and ensures that the product
(OLS), the innovation exchanges can be manufactured in a cost-effective manner, providing evidence to support the product’s value
bring people and organisations proposition. Catapult centres18, the NHS Innovator Accelerator programme19 and SBRI Healthcare20
together, speeding up the all provide innovation opportunities at this step of the pathway.
spread of innovation in the local
area, saving the NHS money,
generating economic growth NHS Innovation Catapult centres
and getting technologies to Accelerator (NIA)
more patients faster. Catapult centres18 facilitate UK businesses, scientists and engineers
The NIA19 supports the to work side by side on late-stage research and development.
uptake and spread of high There are 11 Catapults in total including cell and gene therapy,
impact, evidence-based digital, high value manufacturing and medicines discovery.
innovations across the www.catapult.org.uk
NIHR Applied Research Collaborations (ARCs): Industry
NHS and wider healthcare
In July 2019, NIHR announced a £135 million investment in 15 new
associations system, benefiting patients,
ARCs14, which will join up some of the country’s best universities, leading Various industry associations populations and staff. An NHS
innovators and local authorities, universities, private companies, charities and trade bodies e.g. ABHI15, England initiative, delivered SBRI Healthcare (SBRI)
and academics to solve some of the biggest issues facing health and BIVDA16 and TechUK17 support in partnership with AHSNs,
social care in their region over the next five years. the innovation of medical it currently supports over Supported by the AHSN network, SBRI Healthcare20 is a programme
https://www.nihr.ac.uk/explore-nihr/support/collaborating-in- technologies in the UK and 30 ‘Fellows’ representing an jointly funded by NHS England and NHS Improvement which seeks
applied-health-research.htm the wider EU market. equal number of innovations. to improve patient care and drive efficiency of delivery. Through
Since its inception in research and development, SBRI Healthcare acts as an enabler
2015, the NIA has raised for the NHS to accelerate access to new innovations in their early
over £80m of external stages of maturity, to help solve identified healthcare challenges
funding, and supported and unmet needs. The programme also aims to support economic
over 50 innovations to growth by boosting wealth creation through the adoption of UK-
scale nationally, with just sourced innovations. The programme has been running since 2013
under half of these selling and has awarded around £10million annually through contracts for
internationally. Over 1800 development awarded to innovators, including a recent investment
NHS organisations currently of £5.6 million to support 6 pioneering HealthTech innovations
use NIA innovations. in the fields of mental health and surgery.
https://nhsaccelerator.com https://sbrihealthcare.co.uk22 Navigating the innovation pathway 23
Development (Clinical evaluation)
Q: What evidence is required to clinically
evaluate MedTech products? Q: What support is available to
innovators during this phase?
A: Whilst the clinical trial protocol for pharmaceutical drugs has long been established, the level of
clinical evaluation required to gain regulatory approval for MedTech products is less mature. The
clinical data required by the regulators to demonstrate that a MedTech product performs as intended
A: A number of initiatives are in place to support innovators during the clinical development phase
of their MedTech product. The MedTech and In vitro diagnostic Co-operatives (MICs)23 offer an
alternative to the contract research organisation clinical testing route, whilst the recent launch of the
and is safe to use is dependent on the class of technology (outlined on the Medicines & Healthcare Digital Innovation Hubs will provide innovators with access to real world patient data. NICE operate
products Agency (MHRA) website)21, with higher risk MedTech products requiring more extensive a number of tools and services including the NICE Scientific Advice consultancy27, the MedTech Early
clinical evaluation before they can be launched onto the market. This is summarised below: Assessment (META) tool29 and the HealthTech Connect28 ‘horizon scanning’ database. Support in this
phase of development has been enhanced through the recent launch of the NIHR Clinical Research
Network Health Services Research Toolkit30 and Invention for Innovation (i4i) programme31.
In Vitro diagnostic Level of evidence
Medical devices
medical devices required
Leeds Newcastle
MedTech and In Vitro NIHR Leeds In Vitro NIHR Newcastle In Vitro
Examples: Examples:
Pacemakers Hepatitis B blood- Expected level of diagnostics Diagnostics Co-operative Diagnostics Co-operative
Heart valves donor screening clinical evaluation
Implanted cerebral
Class III Class D HIV blood required: Clinical Co-operatives (MICs) NIHR Surgical MedTech
simulators diagnostic test: Co-operative Sheffield
ABO blood grouping investigations
The newly-formed MICS23 act as NIHR Devices for Dignity
centres of expertise, bringing MedTech Co-operative
Examples: Examples: Nottingham
Bood glucose
together patients, clinicians, NIHR Children and
Condoms NIHR Mental Health
Lung ventilators self-testing researchers, commissioners MedTech Co-operative Young People MedTech
Class IIb Class C PSA screening: Co-operative
Bone fixation plate and industry to support the
HLA typing
development and evaluation of
MedTech products in a clinical Birmingham Cambridge
Examples: Examples: Expected level of NIHR Trauma Management NIHR Brain
Pregnancy setting. Each MIC has a specific
Dental fillings clinical evaluation MedTech Co-operative Injury MedTech
Surgical clamps self-testing theme and is hosted by an
Class IIa Class B Urine test strips required: Literature Co-operative
Tracheotomy tubes
Cholesterol review and/or identified lead NHS organisation.
Class I medical self-testing London
devices will require
Clinical investigations NIHR Cardiovascular
involvement of a Examples: MedTech Co-operative
Examples: Oxford
Notified Body if they Clinical chemistry
Wheelchairs NIHR Community Healthcare MedTech NIHR London In Vitro
are sterile, have a analysers
Stethoscopes Class I Class A
measuring function Specimen receptacles: and In Vitro Diagnostics Co-operative Diagnostics Co-operative
Spectacles
or are re-usable Prepared selective
surgical instruments. culture media Geographical locations of MICs across England
MedTech classes and level of clinical evaluation required Patient Data The landscape for accessing safe and responsible use of health-
for Research ‘real world’ patient data for both related data at scale for research
retrospective and prospective and innovation. www.hdruk.ac.uk
Medicines and MHRA22 regulates medicines, https://www.gov.uk/ research is changing incredibly In the meantime, the Clinical Practice
Healthcare products medical devices and blood government/organisations/ quickly. Supported by £37.5m of UKRI Research Datalink (CPRD)25 facilitates
components for transfusion in medicines-and-healthcare- Industrial Strategy Challenge Fund observational studies, clinical trial
Regulatory Agency the UK. MHRA is an executive products-regulatory-agency (ISCF) funding, Health Data Research feasibility and protocol optimisation
(MHRA) agency, sponsored by the UK (HDR UK)24 is leading the delivery by making de-identified patient data
Department of Health and of the Digital Innovation Hubs – available from a network of GP practices
Social Care. a UK-wide initiative to enable the across the UK. www.cprd.com24 Navigating the innovation pathway 25
Regulation
Q:
Contract Research Partnership with a CRO or another to a standard sufficient to meet What are the regulations
authorised clinical testing body regulatory requirements. Information
Organisations (CRO) for the completion of the clinical is available through the Clinical and for MedTech products?
testing of MedTech products will Contract Research Association26
ensure that the process is completed www.ccra.org.uk
A: As stated previously, there are a number of regulatory requirements that must be met before
a technology can enter the UK and EU market. Until recently, this conformity was in the form
of alignment to one of three EU Medical Device Directives (MDDs).
NICE Scientific Advice NICE SA27 is a fee-based consultancy support the development of evidence
service available to developers of that demonstrates product value and In May 2017, new EU regulations for medical devices were put into force to overcome perceived
(NICE SA) MedTech, working with innovators during provide detailed feedback on clinical, flaws and divergences in the existing MDDs, increasing patient safety via a robust, transparent
the early stages of product development economic development and evidence and sustainable regulatory ‘fit for purpose’ framework.
to encourage consideration of relative generation plans.
clinical and cost effectiveness of www.nice.org.uk/about/what-we-do/
products. NICE- appointed experts life-sciences/scientific-advice Regulation of MedTech products
HealthTech Connect by local AHSN systems, it will reduce MedTech Early Directives • The Active Implantable Medical Devices (AIMD) Directive (90/385/EEC)
the duplication and complexity • The In Vitro Diagnostic (IVD) Medical Device Directive (98/79/EC)
HealthTech Connect28 (previously involved in getting health Assessment (OLD) • The Medical Devices Directive (93/42/EEC)
known as MedTechScan), a new technology to market in the UK. (META) Tool
‘horizon scanning’ database Access to this database will permit
of MedTech products at any improved NHS planning around The META tool29 is an online
stage of development, was introduction and adoption of new service that helps medical
launched in February 2019. This technologies, including those technology developers optimise Regulations • The Medical Device Regulation (MDR) (2017/745)
secure online system replaces through the Accelerated Access their development plans for their (NEW) • In Vitro Diagnostic Medical Device Regulation (IVDR) (2017/746)
and unifies existing sources of Collaborative (AAC), and encourage medical technology. It provides
MedTech information, improving early engagement of innovators a structured framework to
the identification and tracking with the industry. Although not help identify potential gaps
of new and emerging MedTech mandatory, market access may be in product development plans
in development across the UK. delayed if an innovation is not on and the next steps to bring EU member states have competent authorities validity. Manufacturers with a
Developed by NICE, with NHS the HealthTech Connect database. a product to market; been given a 3 to 5-year (MHRA in the UK) During this product already on the market
England funding, and supported www.healthtechconnect.org.uk https://meta.nice.org.uk transition window, with transition period, MedTech will need to update their
the new regulations (MDR can be placed on the market technical documentation and
and IVDR) expected to under either the current EU processes in order to meet
be fully implemented by MDDs or the new regulations. the requirements of the new
NIHR Clinical Research Network NIHR Invention for Innovation (i4i)
26 May 2020 and 26 May However, MedTech devices regulations by the dates above.
Health Services Research Toolkit Programme 2022 respectively32. The placed on the market after
(NIHR CRN HSR toolkit) This funding programme31 supports the pre-clinical implementation of these new the transition period will need In the UK, regulation of
and clinical development of medical devices in regulations have introduced to fully comply with the new medicines, medical devices
Launched as a national resource in July 2019, additional responsibilities regulations, unless they wish and blood components for
the toolkit30 is designed to bring together ideas, areas of existing or emerging patient need. Its main
aim is to de-risk early stage projects that have for the European Medicines to make use of the extended transfusion is overseen by
guidance and practical support together in one Agency (EMA)33 and national period of CE certificate the MHRA10.
place, helping researchers undertake clinical demonstrated proof-of-principle and have a strong
studies in both the NHS and the wider health potential for adoption and commercialisation, making
and social care environment. them attractive to follow-on funders and investors.
https://sites.google.com/nihr.ac.uk/hsrtoolkit/ https://www.nihr.ac.uk/explore-nihr/funding-
programmes/invention-for-innovation.htm26 Navigating the innovation pathway 27
Medical
Devices
Devices class
In Vitro
Diagnostic
Notified body
approval required?
Post-market monitoring
and surveillance Q: How are
products marketed
outside of the
Medical Devices Once a MedTech product has
been placed in the UK market, EU regulated?
I A No the manufacturer is responsible
Increasing risk
for monitoring the product and
A:
IIa B Yes
reporting serious adverse incidents Manufacturers planning
IIb C Yes to the MHRA, to ensure the to launch their product
technology is safe to use. in markets outside of the EU
III D Yes
will need to ensure regulatory
Custom-made devices requirements for each of
MedTech conformity assessment routes the product destinations are
NHS organisations often produce met. The regulatory burden
diagnostic tests in-house or modify for market access to some
Conformity Manufacturers will be issued MedTech to allow clinical teams to countries has been alleviated
assessments with a CE certificate which can respond rapidly to new or emerging by Mutual Recognition
be placed on their product to threats, and to promote the Agreements (MRAs) between
Manufacturers need to show that it has passed the development of more innovative the EU and third-country
demonstrate that their MedTech conformity assessment. solutions through collaboration authorities concerning the
product meets the requirements by medical researchers with conformity assessment of
in the MDR or IVDR by carrying Quality Management peers. Guidance on compliance regulated products. These
out a conformity assessment. requirements for custom-made trade agreements facilitate
The conformity assessment route System (QMS) devices can be found on the UK market access through greater
depends on the classification Companies submitting a Government website36. harmonisation of compliance
of the device (and the risk MedTech product for regulatory standards, and reduced need
Q:
class determines whether or approval in the UK will need to Traceability for duplicated inspections upon What is the implication of Brexit
not a conformity assessment demonstrate alignment to the importation of products. The EU
is required). Undertaken by Manufacturers complying with has MRAs with United States, on MedTech regulation?
ISO Standard 1348535 and other
notified bodies, conformity applicable standards. This is the new regulations will be Australia, Canada, Israel, Japan,
A:
assessments include the review facilitated by the development of required to assign a Unique Device New Zealand and Switzerland39. The EMA moved its Further information on the
of clinical and scientific data, a QMS, a repository of business Indentification (UDI) to the label and/ headquarters from implications of Brexit on the
manufacturing processes and processes, policies, documented or packaging of their product to London to Amsterdam in March UK HealthTech industry can be
the quality management system. information and resources enable traceability within the global 2019. At the time of writing this found in the MedTech Europe
Manufacturers can certify their relating to the development and market, improving the effectiveness guide, it is unknown whether position paper40. Contingency
products with any notified body manufacture and procurement of the post-market safety of the UK will leave the EU with planning guidance for the event
in the EU. The MHRA retains an of the MedTech product. MedTech products and security of a deal. The effect of Brexit on of a no-deal Brexit has been
up to date list of notified bodies the supply chain37. Manufacturers HealthTech regulations in the developed by the Government
for MedTech34. Compliance will also be required to register their UK will be largely dependent and shared with HealthTech
organisation and technology, upload on the deal agreed, if any. manufacturers41.
Most class I medical device Manufacturers are required relevant information, apply for clinical
and Class A in vitro diagnostic to have at least one person investigations and performance
devices do not need to pass available with responsibility studies, and upload post-market
a conformity assessment. for regulatory compliance who surveillance documentation to the
However, they will still need to possesses expert knowledge European databank on medical
be registered with the MHRA. in the field of MedTech. devices (Eudamed)38.28 Navigating the innovation pathway 29
Evaluation and reimbursement
Once a MedTech product has An overview of the NICE evaluation programmes is shown below:
received a CE mark, the manufacturer NICE42 is an executive non- reduce costs and provide whole
is free to sell, lease, lend or gift the departmental public body of the system benefits. NICE helps the
product across Europe. Although Department of Health in the UK, NHS to adopt effective and cost- Clinical performance Better Non-inferior
not mandatory, it is widely accepted responsible for providing national efficient technologies through a
that the case for reimbursement of guidance on medicines and review of evidence and advice from Cost Higher Less overall
MedTech products in the UK (and wider MedTech products and advice to experts and patients, leading to
field) is made fundamentally easier improve health and social care, the publication of market briefings,
through evaluation and endorsement Evaluation method Cost effectiveness (QALY) Cost consequences
highlighting a product’s potential guidance and guidelines relating to
of the health and economic case by to improve patient outcomes, the technologies/topics of interest.
the National Institute of Health and
Care Excellence (NICE)42. NICE guidance Technology Diagnostics Medical Technologies
programme Appraisals Assessment Evaluation Programme
Q: How does NICE Programme (TAP) Programme (DAP) (MTEP)
evaluate MedTech products?
Technologies Devices Diagnostics Devices
A: It takes approximately 38
weeks to develop a piece
of HealthTech guidance. NICE
initially assessed by the NICE
topic oversight group, who
determine if a topic briefing on
offered by the technology
and evidence available.
Diagnostics
is informed of new MedTech the technology and/or MedTech MedTech products likely to result NICE evaluation programmes for MedTech products
products requiring evaluation, Innovation Briefing (MIB) should in an overall increase in resource
either through notification from a be produced. NICE will only costs to health and social care
sponsor (manufacturer, clinician, review technologies which have are routed through either the NICE assesses a product on the limited evidence base before being finalised and
patient or other interested party) a CE mark or equivalent, or if it Technology Appraisal Programme both a benefits and cost basis: available for MedTech products, published on the NICE website.
or through sources (for example, is expected within one year. (TAP) or the Diagnostics a permissive approach is In collaboration with NHS
the National Institute for Health Assessment Programme (DAP), • How well does the adopted to allow consideration England and others, NICE has
Research Innovation Observatory If selected, the topic oversight depending on product type. technology work compared of unpublished as well as recently implemented, an
(NIHRIO) which identify group route the product through Those products likely to deliver to standard practice in published information. Evidence Standards Framework
technologies likely to have the one of three NICE programmes a cost saving or to be cost the NHS? The outcome of the EAC for digital health technologies43.
most benefit to patients and the for full assessment to ensure neutral are routed through the • How much does this assessment is collated into Aligned to the recently updated
health and social care system. that guidance is appropriate Medical Technologies Evaluation course of action cost a report which is reviewed Government’s Code of conduct
Notified MedTech products are for the value proposition Programme (MTEP). compared to standard by the Medical Technologies for data-driven health and care
practice in the NHS? Advisory Committee (MTAC), technology44, the framework
which is responsible for making describes standards for the
MedTech
Innovation Briefing NICE guidance NICE guideline External Assessment Centres the final decision on NICE evidence that should be
(EAC) are employed by NICE recommendations for use available or developed to
to critique the submission and of MedTech products. Draft demonstrate the technology’s
• Product specific • Product specific • Condition / population undertake any further technical guidance recommendations are value to the health and
NICE advice • Systematic review specific
evaluations. Recognising subject to public consultation care system.
• Summary of key of clinical and cost • Systematic review of
clinical evidence evidence clinical evidence
• Summary of existing • De novo economic • Key areas prioritised for
economic models modelling economic modelling
(if available) • Product specific • Recommendations unlikely
• No recommendations recommendations to be product specific
MedTech product journey through the NICE evaluation pathway30 Navigating the innovation pathway 31
MedTech Innovation Briefings (MIBs)
Commissioned by NHS England, MIBs provide evidence-based advice
45
Q: How are MedTech
products
reimbursed?
UK NHS reimbursement
Clinical Commissioning CCGs grant access to the
to those considering the implementation of new medical devices or Groups (CCGs) are clinically- product in their region. NHS
led statutory NHS bodies funding and reimbursement
A:
diagnostic technologies. By making this information available, NICE One of the most common
helps to avoid the need for NHS organisations to produce similar responsible for the planning for products recommended by
mistakes made by and commissioning of the NICE Technology Appraisal
information for local use. MIBs are designed to be fast, flexible companies is the assumption
and responsive to the need for timely information on innovative healthcare services in their Programme, however, is
that, by assigning a price and local area. Responsible for obligatory within three months
technologies. See www.nice.org.uk/about/what-we-do/our- successfully gaining market
programmes/nice-advice/medtech-innovation-briefings approximately two thirds of of guidance being published.
entry, a product will be bought the total NHS England budget, Typically, CCGs will go to
and reimbursed fully in that CCGs exert a significant tender to select formulary
country. It is imperative to influence over the prescribing devices. Progressively CCGs
consider a product’s pricing and reimbursement of are forming larger regional
The National Institute for Health Research strategy, reflecting the MedTech products for use decision-making groups
Innovation Observatory (NIHRIO) different market drivers and by their population. for evaluating devices for
reimbursement policies at this inclusion on formulary, and for
The NIHRIO46 is hosted by the National Innovation Centre for stage of the process to ensure NICE- approved products are devices which are used in both
Ageing, National Institute for Smart Data Innovation, and Newcastle the attractiveness of product not reimbursed until individual hospital and out of hospital.
Academic Health Partners (a collaboration involving Newcastle in the market and maximal
University, Newcastle Upon Tyne Hospitals NHS Foundation Trust and market uptake.
Northumberland, Tyne and Wear NHS Foundation Trust). It undertakes by NHS England, centralises £100 million that can be
‘horizon scanning’ identifying topics and aims to inform NICE of new To understand how reimbursement High-Cost Tariff-
the procurement of a range reinvested back into NHS
MedTech early in development to enable NICE to publish guidance as works, it is important to Excluded Devices of specialist commissioned services. Operated through
close as possible to product launch. www.io.nihr.ac.uk understand how the money (HCTEDs) programme high-cost MedTech products the new NHS Supply Chain
flows. In the UK, MedTech through NHS Supply Chain to OM, providers are now able to
manufacturers sell their products The prices paid by the NHS for
the same high cost MedTech achieve national transparency procure HCTEDs at zero cost,
broadly through three channels: of pricing and combine future with reimbursement by NHS
products can vary up to 50%
between Trusts. The High-cost purchasing power through England. HCTEDs included in
• To an NHS or private aggregation. The programme this programme are set out
healthcare provider to use in Tariff Excluded Devices HCTED
programme47, commissioned expects to release over in the National Tariff.
the secondary care services,
either directly, through
wholesalers or the NHS
Supply Chain;
• To a company who uses Innovation and supports the NHS to adopt proved their clinical effectiveness
the MedTech product in the Technology Payment innovative market-ready MedTech and are ready for nationwide
delivery of their service to which have demonstrated spread. Recognising the concerns
a healthcare provider. (ITP) improvements in the quality and of the sector, NHS England is
• Directly to patients (private In light of the findings from the efficiency of patient care, by committed to funding CCGs to
sale, prescriptions); Accelerated Access Review, NHS removing financial or procurement implement these innovations
England launched a programme barriers to uptake. Each year, for a fixed one-year period,
to support innovative MedTech NHS England carefully selects which maximises the spread
products in the penetration of the a number of cost-effective of these innovative products
NHS market. The ITP programme48 innovations that have already in the NHS market.32 Navigating the innovation pathway 33
Q: What is the Accelerated Access
Collaborative? HeartFlow: A non-
invasive diagnostic
UroLift: A minimally
invasive alternative
A pre-symptom
diagnostic test
A: The new umbrella
organisation for UK
health innovation, the AAC49
clinicians and patients so
innovators understand the
problems to be addressed
test for heart disease52
Artery blockage is currently
treatment for the lower
urinary tract symptoms
for pre-eclampsia54
Pre-eclampsia is a condition
will act as the front door and by establishing a testing measured in the NHS by of benign prostatic by which the placenta
for innovators looking to infrastructure to support an angiogram, an invasive hyperplasia53 does not develop properly,
get their products funded innovators in the generation procedure where a tube leading to barriers for
by the NHS, and identify of evidence required to is inserted into the heart Enlarged prostates are an the normal development
and support the best new enable product adoption. of the patient to measure extremely common condition of the foetus. The main
innovations to benefit The AAC will draw on the arterial pressure. HeartFlow that occurs with age, leading symptoms of pre-eclampsia
patients, driving their uptake capabilities of the AHSN has engineered a unique patients to have difficulty are high blood pressure
and adoption within the Innovation Exchanges to computer programme that passing urine. The NHS currently and proteinuria, which are
health and care system. The enhance the spread of can determine the severity of delivers Transurethral Resection also experienced by healthy
Collaborative, commissioned products over the established artery blockage by analysing of the Prostate (TURP) surgeries pregnancies, making it a
in 2018 by NHS England supply chain channels. CT scans of the heart. The to relieve a patient’s symptoms. very difficult condition to
and NHS Improvement in doctor can use this non-invasive This is an invasive surgery diagnose. A new blood test
response to the findings Since its inception, the AAC NICE approved computer that can damage nerves and developed by Roche and
of the Accelerated Access has selected and supported 12 programme to accurately surrounding tissue. UroLift is a Quidel can predict with
Review50, brings together Rapid Uptake Products (RUPs)51 determine which treatment medical device which anchors 99% accuracy whether
leaders from across the to increase their use within the a patient needs, avoiding the the enlarged prostate in place a pregnant woman will
healthcare landscape, NHS. These include a blood need for an invasive procedure using a 25-minute technique, develop pre-eclampsia
including government, test for early pre-eclampsia or unnecessary stent reducing invasiveness and risk before the occurrence of
NHS, industry and AHSNs. diagnosis and an implant to treatment. for patients. This alternative symptoms. Early diagnosis
The AAC, hosted by NICE, alleviate the lower urinary procedure offers a number of means that the NHS can
utilises existing platforms tract symptoms of benign benefits to the patient including accurately identify high-risk
including HealthTech prostatic hyperplasia. This £2 a reduced hospital stay, quicker pregnancies and redirect
Connect and the NIHRIO, million investment is estimated recovery and fewer post- money to prevention rather
to identify innovations to save the NHS up to £30 operative complications. than treatment.
appropriate for acceleration million and improve the lives
through the scheme. As of around 500, 000 patients.
it matures, the AAC will A selection of these Rapid
support innovators through Uptake Products are outlined
the innovation pathway further on in this report.
by signalling the needs of https://www.nice.org.uk/aac34 Navigating the innovation pathway 35
Commissioning and adoption
Q:
Category towers
How does the NHS supply
Intelligent client £
chain operate? Tower 1 Ward Based Consumables
coordinator
Tower 2 Sterile Interventions and
A: The NHS Supply Chain has achieve significant benefits for and deliver the best products 11 Procurement Associated Consumables
a new operating model the NHS through: at the best value for the NHS. category towers Tower 3 Infection Control and Wound Care
that has been introduced to Logistics
Tower 4 Orthopaedics, Trauma and Spine,
deliver improved procurement and • Increasing uptake/volume Currently only 40% of the and Ophthalmology
logistics support to the NHS. In a of products purchased via NHS’s £6bn spend on everyday Tower 5 Rehabilitation Disabled Services, Women’s
strategic response to the findings the national route to market hospital consumables, common Health and Associated Consumables
outlined in the Carter report55, in order to aggregate goods, high value healthcare
Tower 6 Cardio-Vascular, Radiology, Audiology
the new operating model will national demand, and secure consumables and capital
and Pain Management
enhance procurement efficiency value for money for the equipment goes through NHS
and effectiveness across the NHS, NHS and taxpayers; Supply Chain. Implementation Tower 7 Large Diagnostic Capital Equipment
Transactional including Mobile and Consumables
delivering clinically safe, high • Increasing use by the NHS of of the new operating model is
quality products for the a standard range of clinically expected to double this to 80%, services Tower 8 Diagnostic, pathology and therapy
best possible value. appropriate products to reduce releasing an estimated £2.4bn technologies and services
unwarranted variation in the of savings in its first five years Tower 9 Office Solutions
Supporting technology
Transformation and system; and of operation, which can be used infrastructure Tower 10 Food
re-procurement of the NHS • Using increased buying power by the NHS for reinvestment Tower 11 Hotel Services
Supply Chain is expected to to affect purchasing behaviours in front line services.
NHS supply chain procurement
category towers Q: How are MedTech products
commissioned by the NHS?
10%
Fourteen separate contracts
have been awarded to service
providers that will manage
A: There are six main routes
to market for companies
interested in supplying their MedTech
• Aggregation of demand could offer
suppliers larger volume opportunities
than the current NHS Supply Chain;
20% 10% the Category Towers, and product directly to the NHS: • Lowered sales and marketing
40% 80% the procurement of logistics, costs by reducing the number of
transactional services and IT • Selling direct to trusts or primary
interactions with Trust procurement
care organisations;
40% services for the NHS for a three-
• Selling through the new NHS
teams, as the NHS Supply Chain
year period. Oversight and can act as a single point of contact
operational management of the Supply Chain;
for supplying into the NHS;
new contracts and services along • Selling through collaborative
• Clinical assurance that products are
with customer engagement purchasing arrangements;
being procured on the basis of user
activities will be delivered by • National framework collaborations
requirements, not simply unit price;
the management function of and contracts;
Hubs • Sales commitment making
the NHS Supply Chain, The • Government tenders and contracts;
NHS Supply Chain business and production planning
intelligent Client Coordinator. • Selling to a company which then
Trust Procurement Teams (200+) Changes to the NHS procurement landscape easier for suppliers;
uses the MedTech product in the
• CTSP incentivisation to reduce
The NHS supply chain is centrally delivery of their service
The procurement function of the NHS Supply Chain is managed through 11 Category Towers. These to an NHS provider. total cost in the system, not just
funded and the price of goods reduce unit price; and
towers are operated by a Category Tower Service Provider (CTSP) who has specialist knowledge are passed onto trusts with
of that product category to enable them to undertake the clinical evaluation of products, run The new operating model is expected • A streamlined procurement
no additional margin. to promote a number of opportunities landscape will reduce the burden
compliant procurement processes on behalf of the NHS and create strategies that sustainably
provide the NHS with clinically assured products that drive the best value. for suppliers when selling to the NHS: of multiple tenders.You can also read
