UK Trade & Investment is the Government Department that helps UK-based companies succeed in the global economy. We also help overseas companies bring their high-quality investment to the UK’s dynamic economy acknowledged as Europe’s best place from which to succeed in global business.

UK Trade & Investment offers expertise and contacts through its extensive network of specialists in the UK, and in British embassies and other diplomatic offices around the world. We provide companies with the tools they require to be competitive on the world stage.

Part of the UK Government’s portfolio of Solutions for Business

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Published in September 2013 by UK Trade & Investment © Crown Copyright URN 13/1127

Unlock Your Global Business PotentialUK Medical TechnologyUKTI Life Science Investment Organisation (LSIO)

www.ukti.gov.uk/lifesciences

INNOVATION IS

Market Success

Join other international businesses in accessing UK expertise and opportunities to ensure patient benefit and business success.

Johnson & Johnson opens a global Innovation CentreJohnson & Johnson established one of its four regional innovation centres in London. The Innovation Centre, serves as a European Hub to accelerate innovation across the healthcare landscape. The Centre will serve as a regional hub focused on identifying early-stage innovations, and establishing novel collaborations to invest in and speed development of those innovations to solve unmet needs in patients.

The innovation centres will help to deepen our relationships with the communities in key innovation hotspots and better support local entrepreneurs. Ultimately, they will serve to help us more quickly identify and tap into technological advancements that have the potential to benefit the health of people in the future.”

Patrick Verheyen, Head of the London Innovation Centre

NOCRI brings Vidacare Corporation to the UK for clinical researchVidacare Corporation, a medical device company based in San Antonio, Texas, has developed the OnControl® Bone Access System. This is a handheld rotary-powered device that has been shown to improve the safety, control and comfort of biopsy procedures.

The NIHR Office for Clinical Research Infrastructure (NOCRI) supported Vidacare by linking it with the right clinical research experts in the UK, who are currently working to help the company develop and set-up a randomised controlled trial.

NOCRI was able to communicate the benefits of doing research through the NIHR, including where to find relevant MedTech expertise in the NIHR Clinical Research Network, and make the necessary introduction.

Thanks to NOCRI’s expert help, the development of a study within the NIHR will benefit not only Vidacare, but patients within the NHS. We’re very keen to work with the NIHR and look forward to when the trial is developed and can fully progress.”

Dr Thomas Philbeck, Vidacare’s Senior Director, Science & Clinical

Whereas every effort has been made to ensure that the information given in this

document is accurate, neither UK Trade & Investment nor its parent Departments (the Department for Business, Innovation and Skills, and the Foreign & Commonwealth

Office) accept liability for any errors, omissions or misleading statements, and no warranty is given or responsibility accepted

as to the standing of any individual, firm, company or other organisation mentioned.

Unlock Your Global Business Potential: UK Medical Technology

Market OpportunityThe global medical technology market is expected to double to approximately £300bn by 2015. Despite a difficult economic climate in which other sectors have struggled, the UK medical technology sector has rapidly grown.

Between 2009-12, the UK medical technology sector:

• Increased its combined turnover by 50%

• Increased the number of medical technology companies based in the UK by 12%

• Increased the number of people employed in the sector by 40%.

The three largest segments in the UK offer your medical technology company access to a range of opportunities. They are:

1. The UK National Health Service (NHS) which in 2011-12 spent approximately £128bn across the UK. Treating almost 1 million ethnically diverse patients on a daily basis, the NHS is the largest unified healthcare system in the world.

2. The UK private healthcare market is growing and is estimated to reach £35bn by 2015.

3. The UK social care market, dominated by assistive technologies, is set to grow from £2bn in 2012 to £6bn in 2020.

Ease of Doing BusinessThe UK Government continues to improve the business environment to help companies succeed.The UK offers businesses:

• Low corporation tax rate – 23% dropping to 20% from April 2015

• Patent Box – companies are now able to apply a corporation tax of 10% to profits earned from their UK-registered patents

• R&D Tax Credits – providing up to 27p back per £1 of qualifying R&D expenditure for SMEs

• Access to soft funding – £180 million Biomedical Catalyst non-dilutive funding for translation and commercialisation and the Invention for Innovation (i4i) funding for the development of innovative medical technologies.

3,129 UK based medtech

companies employing over

71,000 individuals

UK medical devices market rising by

7.3% per year reaching £9.1bn

by 2018

UKTI Life Science Investment Organisation (LSIO)UKTI has established a dedicated unit, the Life Science Investment Organisation (LSIO), to act as your interface with the UK life science sector. The LSIO is your guide to identifying research, development and delivery partners and will support you through every step of investing in and working in the UK. The UKTI LSIO team will work closely with you to understand your needs and requirements, partnering you with the right people in the UK.

For further information please contact the UKTI LSIO team at:

03The UK Medical Technology Opportunity

ContentsThe UK’s Commitment to Medical Technology 4

The UK’s Medical Technology Market Opportunity 8

Ease of Doing Business 10

Rich and Diverse Ecosystem 14

ResearchandDevelopmentBasedonUnmetClinicalNeeds 14

Design,PrototypeandManufacture 19

ClinicalResearch 25

RegulatoryApproval 31

HealthTechnologyAssessmentandMarketEntry 33

How UK Trade & Investment (UKTI) Can Help Your Business 37

R&D based on

unmet clinical needs

Design, prototype and manufacture

Clinical studies

Regulatory approval

Health technology assessment and market

entry

Determine gaps in care

Iterative development

Test

effica

cyValidate

Show

val

ue

Clinicians and patients

Anonymised patient data

Supportive funding and investment environment

The UK offers your medical technology business:■ Anationalisedhealthserviceprovidingunrivalledaccesstoasingle

healthcaremarketof62millionpeople

■ World-classresources,academicinstitutionsandresearchtoproveconceptsforinnovativemedicaltechnology

■ Manufacturingcapabilitiestodesign,prototypeandengineermedicaltechnologies

■ Anationalclinicalresearchinfrastructuretotranslateresearch,accesspatientsandvalidateanddesign,utilityandeffectivenessofyourmedicaltechnology

■ AfastandsupportiveregulatorysystemforCEMarking

■ Healtheconomicassessmenttobuildevidencetowardsearlyadoptionandmarketentry

■ Accesstoanonymisedpatientdata

■ Accesstogovernmentincentivesandtaxbreaks

■ Asupportiveinvestmentenvironmentforyourbusiness’growth

■ SupportavailablefromUKTrade&Investment(UKTI)tohelplaunchyourbusinessintotheUKandthenintointernationalterritories.

Health economics appraisal to build evidence towards early adoption and market launch The UK is a world leader in health technology assessment and home to the National Institute for Health and Care Excellence (NICE). With an increasing focus on clinical and cost effectiveness globally, and the need to demonstrate value to the patient and to health systems, your business can leverage the UK’s expertise to develop an evidence base to support market access, uptake and diffusion. The newly formed Academic Health Science Networks (AHSN) present a new mechanism to facilitate the adoption and spread of innovative technologies.

A fast and supportive regulatory system for CE marking The Medicines and Healthcare Regulatory Authority (MHRA) is one of the most heavily utilised Competent Authorities in the European Union. By undertaking health research in the UK and being assessed by a rigorous and globally renowned health regulator, your business can ensure better portability and prestige of your medical technology across the rest of the world.

A single healthcare provider open to working with universities and industry to define clinical unmet needs The highest number of skilled engineers and scientists in Europe and home to four of the top six universities globally, this wealth of talent provides your business the opportunity to collaborate with clinicians, scientists and engineers to develop innovative technologies to meet patients needs. Manufacturing capabilities to design,

prototype and engineer medical technologies

UK medical technology companies benefit from a comprehensive supply chain offering professional support, contract services for product development, design and prototyping, through to manufacture, supply and distribution. Four dedicated UK Centres of Excellence in Medical Engineering are already working with international companies to provide access to this supply chain.

Access to patients, data and a national research infrastructure to validate your technology infrastructure to support and progress prototyping, iterations and product development The NIHR Office for Clinical Research Infrastructure (NOCRI) supports medical technology companies by offering a fast, easy and consistent point of access to clinical research infrastructure to support and progress product development. Access to well-characterised cohorts of patients within the 60 + million people who use the NHS further enables you to test your products with the right patient groups. Similar research infrastructures provide access to clinicians and patients within Scotland, Northern Ireland and Wales.

Healthtechnologyassessment and market

entry

R&D based on

unmet clinical needs

Design prototype and manufacture

Regulatory approval

Clinical studies

E: enquiries@ukti-invest.com www.ukti.gov.uk/lifesciences @UKTI_LSIOT: +44 (0)20 7333 5442