UK Lifescience Industry

Issue 6

United Kingdom

Advances in health technology

INDUSTRY

Going Global

Enhancing opportunities for international life science trade

Enhancement: Improving medical technology Future watch: Potential healthcare game changers Made in the UK: Keeping manufacturing on home turf Meeting the unmet: Responding to unmet clinical needs

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2013 Medilink UK Award Winners Inside UK Lifescience Industry Magazine

Life science is in our blood Life science branding is important to us. It’s our life blood.

Creating compelling experiences through digital and print mediums is at the heart of what we do.

We can inject new life into tired brands, reinforce existing brands or create powerful new ones.

Give us a call or visit our website to see how we could Fisherand Editor improve yourJess message create brands to get your Jess Fisher Editor blood pumping.

“

A message from the chairman of Medilink UK

Trading outside the box Having just returned from a successful mission to the Issue 5 US, which was attended by the NHS and a plethora of UK companies, at the forefront of my mind is the 2012 ISSUE 4 importance of companies developing an effective international trade strategy.

Issue 5 2012 ISSUE 4

It is very tempting for busy organisations to take the Issue 5 obvious choices in respect of entering international markets or to go where business support organisations are already providing successful trade programmes.

Lorem ipsum sectetur adipisici However, this may mean developing trade activities that Lorem ipsum dolor sit amet, conare not best suited to a company’s products or services tempor incididun sectetur adipisicing elit,ased do eiusmod and by focusing here could company only be putting magna Ut Lorem ipsum dolor sit amet, itself up against greater competition and conmissing out aliqua. on tempor incididunt ut labore etopportunities dolore the growing number of significant in other sectetur adipisicing elit,adsed do eiusmod eu fugiat nulla pa magna aliqua.

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tempor incididunt ut labore et dolore eu fugiat epteur sintsignificant Althoughnulla some pariatur. of these markets may have magna aliqua.

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We cupidatat also showcase variety of new technologies nisi ut aliquip ex ea commodo consequat.

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I very much hope that you enjoy reading this edition.

consequat. Duis aute i veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip excommodo ea Lorem ipsum dolor sitDuis amet, consectetur adipisicing elit, sedin dovoluptate eiusmod commodo consequat. aute irure dolor in reprehenderit velit esse cillum dolore eu fugiat tempor ut labore et dolore magna aliqua.

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Excepteur orem dolorconsectetur adipisicing sit amet, veniam, nostrud adipisicing exercitationelit, ullamco nisitempor ut aliquip ex ea ut sit amet, quis consectetur sed dolaboris eiusmod incididunt labore et dolore magna aliqua. U commodo consequat. auteUtirure dolor in reprehenderit voluptate labore et dolore magnaDuis aliqua. enim ad minim veniam, quisinnostrud Chairman, Medilink UK exercitation ullamco laboris nisi velit esse cillum dolore eu fugiat nulla pariatur. ipsumDuis dolor exercitation ullamco laboris nisi ut aliquip ex eaExcepteur commodoorem consequat. aute irure dolor in reprehenderit sit amet, adipisicing elit, sed do eiusmod tempor aute irureconsectetur dolor in reprehenderit in voluptate velit esse cillumincididunt dolore eu ut fugiat nulla pariatur. Excepteur s laborenulla et dolore magna aliqua. Ut ad minim veniam, nostrud fugiat pariatur.

Excepteur sintenim occaecat cupidatat nonquis proident, sunt in exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in

Tony Davis

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The views expressed in this publication do not necessarily represent UKwww.teamworksdesign.com Lifescience Magazine the opinions of individual Medilink UK members unless explicitly stated. © MediWales Ltd. 2012

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United Kingdom

2012 ISSUE 4

4-8

Issue 5

“

A message from the editor

INDUSTRY

Advances in health technology

Going Global Enhancing opportunities for international life science trade

This edition

Lorem the ipsum dolor sit amet, 2013 conBeyond BRIC sectetur adipisicing elit, sedMedilink do eiusmod UK AWARDS tempor incididunt ut labore et dolore 10 Celebrating achievement magna aliqua. Ut enim ad ullamcoin in UK healthcare eu fugiat nulla pariatur. epteur sint More and more companies are looking to the world’s emerging, high-growth markets to drive their export because international trade is an increasingly vital part of life science business. On these lines, it is important to remember that international trade is not only confined to the exporting of products but comes in many different forms.

Therefore, the lead article focuses on how best to do business abroad whether that be with the more established markets of Europe andipsum the US, the BRIC countries orem dolor sit amet, consectetur adipisicing elit, sed do of Brazil, Russia, India and China or eiusmod tempor incididunt utthe labore et dolore magna aliqua. Ut Middle and Far East. It also investigates enim ad markets minim veniam, quis nostrud exercitation ullamco laboris Pharmerging and what these global landscape mean Duis for aute irure dolor in nisi utchanges aliquip in exthe ea commodo consequat. businesses with an international strategy. reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur.

Made in the UK 24 Right royal software solutions

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Enhancement

Excepteur occaecat cupidatatinnon proident, sunt in culpa qui officia Othersint British advancements the life science sector are through the deserunt mollit anim idexplored est laborum. themes of: 16 Early cancer diagnosis The battle against hospital l Enhancementmedical adipisicing elit,17 Lorem ipsum dolor sitimproving amet, consectetur sed do eiusmod infections technology tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim l Future watch- potential healthcare game veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea changers commodo consequat. Duis aute irure dolor in reprehenderit in voluptate l Made in the UK- keeping velit esse cillum dolore eu fugiatmanufacturing nulla pariatur. Excepteur orem ipsum dolor on home turf sit amet, consectetur adipisicing elit, sed do eiusmod tempor incididunt ut unmetresponding unmet laborel Meeting et dolorethe magna aliqua.

Ut enimtoad minim veniam, quis nostrud clinical needs exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiatLucinda nulla pariatur.

Excepteur sint occaecat cupidatat non proident, sunt in Dargavel Editor

Future watch

20 Virtual human anatomy 23 IT supports clinical decisions PUBLISHED FOR

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by Atlantic Teamworks Design &4DZ Marketing Tel: 029 2047 3456 Web: www.mediwales.com

The views expressed in this publication do not Contact: necessarily represent the opinions of individual Editor: UK Jess Fisherunless explicitly stated.

Medilink members © MediWales Ltd. 2013 jess@uklifescienceindustry.com

39 UK Lifescience Industry Event Calendar

27 28 31 32

Seeing is believing Great British research Edgbaston on the global stage Time’s up for hospital associated infections

Meeting the unmet 34 National wound care centres 36 Big push for battlefield haemostat 37 Pushing the boundaries of infection control 38 Devices for dignity

View an interactive version of this edition at www.medilinkuk.com

www.medilinkuk.com

Going global Enhancing opportunities for international life science trade

4

UK Lifescience Industry Magazine

Going global

Nothing

International trade is an increasingly vital

is more

be with the more established markets

expensive than a missed

part of life science business. Whether that of Europe and the US, the BRIC countries of Brazil, Russia, India and China or the Middle and Far East.

opportunity –

It is important to remember that international trade is not only confined to the exporting of finished product but could also be:

H. Jackson Brown Jr

the provision of services joint ventures or strategic alliances licensing or forms of technology transfer mergers, acquisitions or outward investment contract manufacturing or collaborative R&D We are seeing more and more companies look to the world’s emerging, high-growth markets to drive their export growth both today and increasingly in the future.

The BRIC markets continue to offer major opportunities for UK exporters, with healthcare expenditure forecast to continue to grow steadily in the future. Together, the four BRIC countries comprise more than 2.8 billion people or 40% of the world’s population, cover more than a quarter of the world’s land area over three continents, and account for more than 25% of global GDP. These markets are often heavily reliant on imports of advanced medical technology to fill this demand – Brazil is a great example of this, with over 80% of medical equipment currently being imported from overseas. We are also beginning to hear more about the CIVEST future markets, a grouping of Columbia, Indonesia, Vietnam, Egypt, Turkey and South Africa which are perceived to have reliable and sophisticated regulatory, political, financial and legal systems, young populations and a fast growing middle class. However pharmaceutical companies may prefer Mexico as the market on which to focus on in the next five years.

5

UK Lifescience Industry Magazine

Developed Markets: by 2016 developed markets will account for According to figures released 57% of global spending on life sciences

by TCS (Tata Consultancy Service), by 2016 developed markets will account for 57% of the global spending in life sciences. This being a decrease from 73% in 2006; a clear trend which should influence the development of future international strategies.

There are many concerns about exporting and expanding into new international markets. These include difficulties identifying a suitable partner, building relationships with decision makers, finding the time and/or resources to devote to business overseas, import tariffs and regulation as well as the issue of intellectual property.

Developed Brazil: Brazil: 80% of medicalMarkets: equipment imported However, companies looking to 80% offrom medical equipment overseas trade abroad should understand imported from overseas that there are support programmes Pharmerging markets: China, Brazil, India, Russia, Mexico, Turkey, and initiatives available to help Poland, Venezuela, Argentina, Indonesia, South Africa, Thailand, them to successfully break down Romania, Egypt, Ukraine, Pakistan and Vietnam (Lee to illustrate?)

Developed these barriers.

80%

80%

Pharmerging markets: China, Brazil, India, Russia, Mexico, Turkey, Poland, Venezuela, Argentina, Indonesia, South Africa, Thailand, Romania, Egypt, Ukraine, Pakistan and Vietnam.

Markets: by 2016

57%

With opportunities in major developed markets IMS Health defines pharmerging Developed international growth markets will account for countries as those having more Markets: byaccount 2016for continuing to prove lucrative, life 57% of global Developed Markets: by 2016 developed markets will than $1 billion in spending growth 57% of global spending on life sciences science and healthcare technology developed markets spending on life from 2012 to 2016 and a per companies should now be looking will account for 57% sciences capita gross domestic product of to their export portfolios as a of global spending less than $25,000 priority – not as an afterthought.

Pharmerging markets: China, Brazil, India, Russia, Mexico, Turkey, on life sciences Poland, Venezuela, Argentina, Indonesia, South Africa, Thailand, Romania, Egypt, Ukraine, Pakistan and Vietnam (Lee to illustrate?)

Developed markets Emerging markets Future markets

Europe & US Brazil, Russia, India and China (BRIC) Columbia, Indonesia, Vietnam, Egypt, South Africa and Turkey (CIVEST), and Argentina, Mexico, Asia and Latin America.

Pharmerging markets:

6

l China l Brazil l India l Russia l Mexico l Turkey l Poland l Venezuela l Argentina l Indonesia l South Africa UK Lifescience Industry Magazine l Thailand l Romania l Egypt l Ukraine l Pakistan l Vietnam

Developed Marke 57% of global spen

Going global

%

Peter Wheeler, Medilink UK International Sector Specialist

0

0

Businesses that trade internationally:

2012-2016

l learn from their customers

l become less dependent on their local & UK customer base l become more flexible in their approach and are more adaptable to

change

l are able to compete in an increasingly competitive global market l are more likely to have productivity growth

Advice:

16 -20 2 l remember to 1 never ignore your domestic market and existing clients l make exporting part of your business strategy

20

“

“Medilink works closely with UKTI to provide support to companies in growth markets: for example Medilink managed the UK pavilion at Hospitalar, the biggest healthcare technology exhibition in Latin America, and also took out the largest group of UK life science companies that we’ve ever taken to Brazil. Our relationships in this market are well established as reflected in a Memorandum of Understanding with ABIMO, the largest medical device trade association in Brazil, to help UK companies seeking reciprocal partnerships.”

Companies should not be blinkered into thinking that the BRIC markets are the only ones with high-growth potential – UKTI have a list of 20 highgrowth markets where they can offer increased levels of support to UK exporters. This list includes markets as diverse as Mexico, the UAE and Singapore. Grants are available through the Tradeshow Access Programme of up to £3k for companies going to shows in high-growth markets and the devolved countries each have similar support programmes in place.

1

l always research markets and their opportunities thoroughly - choose

those which offer the highest chances of success

l carefully select your agents or distributors and consider them as part of

£ bn

your working team

2012-2016

l establish strong relationships with your customers l always take advantage of any available advice and support

medical equipment imported rom overseas

1

$25,000

20

16 Developed -20 2 Markets: by 2016 1 developed markets will account for 57% of global spending on life sciences

GDP LESS THAN

£ bn

Pharmerging countries: IMS Health defines these as

$25,000

having more than $1 billion in spending growth from

GDP LESS THAN

2012 to 2016 Pharmerging countries: Defined by IMS Health as having a per capita gross domestic product of less than $25,000 from 2012 to 2016

UK Lifescience Industry Magazine

Alternative entry Emerging markets are highly attractive due to their sustained growth potential, capability for costeffective innovation and significant cost savings. However, there are issues such as: l immature logistics and

distribution

l difficult and slow regulatory

approval systems

l inadequate manufacturing

infrastructure l uncertainty in pricing and reimbursement l complex taxation structure and high import tariffs l shortage of skilled staff

An increasing number of UK companies are successfully trading with the BRIC markets. However, the regulatory procedures which they have had to navigate such as ANVISA in Brazil and SFDA in China, have been tortuously slow and import tariffs can also be high.

Therefore, a proposal for the BRIC countries would be alternative entry strategies or partnerships. The existence of these regulatory issues does not mean that we cannot work with the BRIC countries, it just means that we need to look at the wider perspective.

Alternative market entry strategies for BRIC Open innovation workshops Idea generation Collaborative R&D Contract manufacturing Delivery of finished products Producers

Healthcare Healthcare delivery is now one of the world’s largest and fastest growing sectors and healthcare technologies constitute some of the highest value commercial outcomes from national, public and private sector R&D. The UK Government has signalled its commitment to international trade and investment with the recent launch of Healthcare UK, a joint initiative between the Department of Health, the NHS and UKTI. This strategic initiative will help international customers from both the public and private sectors access the UK’s healthcare expertise and aims to boost the value of the UK’s trade in healthcare products and services.

8

There are four large markets for healthcare – Brazil, Middle East, India and China. The focus here is on delivery of high-quality healthcare in countries where populations are growing at a rapid rate. Healthcare UK has been set up to provide a one-stop-shop for governments and healthcare providers looking to access NHS expertise and in turn develop their own systems. Initially, it aims to address this in 5 main areas – primary care, medical education and training, digital healthcare,

UK Lifescience Industry Magazine

infrastructure (PPPs) and health systems development. The most predominant is that of the delivery of health systems and services. In promoting NHS expertise in emerging markets, it is also intended to provide a bridge for life science businesses to enhance their profile, through joint initiatives. For example, Healthcare UK recently organised an oncology mission to India, led by internationally renowned UK clinicians and including leading technologists and life science companies.

One of the reasons why the healthcare market is likely to double in size over the next 10 years is due to the fact that in emerging markets the demand will rise at a much faster

“

“there is a vast array of opportunities for selling UK healthcare skills and know-how overseas, and I’m really excited about doing that.”

Howard Lyons, Leader, Healthcare UK

To find out more about how Healthcare UK could assist you in developing your business in Brazil, India, China or the Middle East, please email the team at: healthcare.uk@ukti.gsi.gov.uk

rate than within those which are thought of as traditional. The Zhejiang province alone is currently a region of 55 million people.

Healthcare UHS in Brazil launched in 1988 and is actively looking to the UK for help in developing its primary healthcare systems knowing that the UK is recognised as number 1 the world over. The know-how is the key.

Zahid Latif, Head of Healthcare, Technology Strategy Board (TSB): The TSB choose markets which are a mixture of excellent market opportunities for companies and also act as innovation missions. They look to those which are world class investment opportunities – which is why they choose to attend those held in San Francisco and Boston. The proximity of the J. P. Morgan Conference to Advamed guarantees that high volumes of people will be in town at the same time which makes for a thriving investment community.

The norm is for companies attending these events to be earlier stage companies looking at what it might mean to do business internationally. In reality, they could be 3 years away from the actual…

The TSB’s missions focus on innovation.

The TSB aims to help companies understand what strategy actually looks like and to challenge those on their missions to think differently about innovation.

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2013 Medilink UK Celebrating the best in UK healthcare at the Medilink UK Awards The finest companies in the UK’s Life Sciences and Healthcare Technology sector have been celebrated at the 2013 Medilink UK Healthcare Business Awards.

The Medilink UK Awards, this year hosted at the NHS Healthcare Innovation Expo, at the ExCel Centre, London, is an annual event celebrating cutting edge technologies, outstanding business achievements and international successes across the UK’s Life Sciences sector.

Nominees were shortlisted from the regional awards which were selected by Medilink Uk’s network across the UK and the overall winners were then chosen and honoured at this prestigious event from the following five categories:

Start-up Innovation Partnership with the NHS Export Achievement Outstanding Achievement

Hosted by celebrated international broadcast journalist Edie Lush, guests recognised the achievements of the award winners and networked with some of the leading professionals from the life science sector, UK government, research institutes and overseas organisations.

This year the awards were supported by the NIHR Devices for Dignity Healthcare Technology Co-operative- the organisation which drives forward innovative new products, processes and services to help people with debilitating conditions preserve their dignity and independence.

Tony Davis, Medilink UK’s Chairman, said: “Set against the backdrop of innovation and wealth creation, driven by the Department of Health’s Innovation, Health and Wealth strategy, NHS Expo was a great opportunity to celebrate the excellence of the UK’s life science sector through the Medilink UK Awards.

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UK Lifescience Magazine

“I would like to extend massive congratulations to all of our winners. Their success is further proof that our sector is in excellent health and gives us great encouragement for the years ahead.”

AWARDS Start-up Award Winner of the Start-up Award, supported by NSF-DBA Medical Devices, was East Yorkshirebased Savantini, for its research, design and retailing of products to help men and women improve pelvic floor problems, bladderweakness and other health related issues. www.savantini.com

Innovation Award Edinburgh-based DySIS Medical won this year’s Innovation Award, supported by the HealthTech and Medicines KTN. DySIS Medical won the award for its development of ground-breaking technology for the evaluation of epithelial based cancers using dynamic spectral imaging. www.dysismedical.com

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UK Lifescience Magazine

Export Achievement Award The Export Achievement Award, supported

by The Engine Room, was awarded to Llanellibased Chromogenex Technologies. The company secured the award for its outstanding record in selling its range of laser and lightbased products for the medical and cosmetic market to more than 50 countries worldwide. www.chromogenex.com

Partnership with the NHS Award The Partnership with the NHS Award, supported

by Array Media, was awarded to Truro-based myClinicalOutcomes. The web-based clinical data collection and reporting platform, developed by clinicians, allows patients with orthopaedic conditions to monitor their progress remotely and long-term using clinically validated assessments. www.myclinicaloutcomes.co.uk

Outstanding Achievement Award Deltex Medical, based in Chichester, won this year’s coveted Medilink UK Outstanding Achievement Award, sponsored by Eversheds. Deltex Medical designs, manufactures and markets its CardioQ-ODM Oesophageal Doppler Monitor, a device that provides a solution to fluid management in surgery and intensive care.

Recommended by NICE in 2011 for use in over 800,000 NHS operations, it was cited within the Department of Health’s Innovation, Health and Wealth as one of the six high impact innovations to be adopted by the NHS in 2013/14. www.deltexmedical.com

UK Lifescience Industry Magazine

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UK Lifescience Industry Magazine

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Unlock Your Global Business Potential The UK has a rich heritage of life science discovery that has transformed scientific knowledge and continues to unlock clinical and commercial opportunities. From the building blocks of the new genomic age, to the secrets of cells, and the physics that makes magnetic resonance imaging possible, UK science is world-class, offering industry an opportunity to partner with globally recognised pioneers and innovators.

The UK offers your medical technology business: • • • • • • • • • •

A nationalised health service providing unrivalled access to a single healthcare market of over 60 million people World-class resources, academic institutions and research to prove concepts for innovative medical technology Manufacturing capabilities to design, prototype and engineer medical technologies A national clinical research infrastructure to translate research, access patients and validate and design, utility and effectiveness of your medical technology A fast and supportive regulatory system for CE Marking Health economic assessment to build evidence towards early adoption and market entry Access to anonymised patient data Access to government incentives and tax breaks A supportive investment environment for your business’ growth Support available from UK Trade & Investment (UKTI) to help launch your business into the UK and then into international territories.

With well characterised populations and integrated research, the UK can be a great launch pad for market access and adoption of your technology in Europe and beyond. The UK’s excellent reputation in research, clinical development, health regulation, and health economics combined with the UKTI Life Science Investment Organisation’s (LSIO) own global connectivity means that the UK can help your business maximise the potential of your health technologies or services.

The UKTI LSIO is here to help your business navigate the opportunity to partner with and invest in the UK, and to connect you to the wider UK life Science community.

For further information please contact the UKTI LSIO team at: T: +44 (0)20 7333 5442 | E: enquiries@ukti-invest.com www.ukti.gov.uk/lifesciences |

@UKTI_LSIO

ukti.gov.uk/greatbritain

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UK Lifescience Industry Magazine

ENHANCEMENT Improving medical technology

Early Identification Proves Positive

The early identification of cancer is a target for a great deal of research. Professor John Robertson from the University of Nottingham has recognised that autoantibodies from a patient’s immune system could amplify cancer cell signals and therefore act as a more easily measured indicator of the presence of early stage cancer; Oncimmune has been launched as a spin out company to commercialise these findings.

Oncimmune has developed this initial concept to produce a commercial EarlyCDT test for lung cancer which is non-invasive, well tolerated and has a much higher positive predictive value than current screening methods.

The company has also developed proprietary technologies in molecular biology, protein chemistry, immunochemistry and medical statistics in order to become the only company to launch a commercial assay.

Sales of EarlyCDT- Lung tests are rapidly increasing with strong demand from the US where the product recently gained US regulatory approval (CLIA). The EarlyCDT- Lung test was launched in the UK in 2012 and is currently part of a large scale clinical trial alongside CT screening, which will roll out across the NHS in Scotland over the next 6 months. Oncimmune anticipates that the test has the potential to be widely utilised for lung cancer screening in the UK for the high risk group.

Research facilities in Nottingham are currently supplemented by a fully compliant service lab in Kansas, USA and Oncimmune plan to build the business over the next three years with the introduction of at least two more early stage cancer tests (breast and hepatocellular).

Visit www.oncimmune.com for more information

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UK Lifescience Industry Magazine

Enhancement

Renfrew helps battle against hospital infections The fight in hospitals against Healthcare Associated Infections (HCAIs) and other infections such as C. difficile, MRSA and norovirus has been well documented over recent years. A collaborative effort has resulted in an innovative project to assist in this battle.

Over the last two years product design specialist Renfrew Group International has worked with the UK Department of Health and the NHS on a design and prototyping project to solve this problem. They

have devised a Temporary Side Room (TSR); designed to provide flexible temporary isolation facilities and airborne infection control. The TSR creates an effective barrier around the infected patient, enabling parts of open wards to be converted into single occupancy rooms, providing increased protection to other patients and encouraging behavioural change in relation to hand washing rates.

Renfrew say their Temporary Side Room embraces a direct need in the NHS and their aim is to revolutionise the way in which patients with infections are treated on regular wards. Side rooms are rarely available for isolating patients with infections and they say the TSR is showing the route forward to delivering a low cost solution

which can pop up within an hour, provides hand washing and air management facilities and has been shown to improve infection control procedures.

This TSR project recently won the ‘Service Challenge’ category of the Innovator’s Den competition at the NHS Healthcare Innovation EXPO.

“

Mike Phillips, Design Development Director at Renfrew Group International says, “Winning the award has been excellent for Renfrew as it has promoted our thinking to a wider audience of business and NHS leaders at the very time when we are looking for partners to develop a TSR3, ready to commercialise and deliver into the NHS to meet a substantial unmet demand.”

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UK Lifescience Industry Magazine

ADVERTORIAL

Unique Device Identification Service Delivering compliance to UDI Companies across the world manufacturing products sold into the US Healthcare marketplace, whether directly or via distribution, will soon be required to conform to a new Unique Device Identification (UDI) standard being introduced by the US Food and Drug Administration (FDA).

Getting Ready Now

on the device itself.

Challenges for organisations required to conform to this standard vary but at the most basic level, all suppliers must understand the FDA UDI requirement and the impact of the new UDI and DPM compliance requirements on their business. That includes being able to evaluate the cost of compliance. The FDA calculates the initial cost of compliance is between 1-8% of revenue. The cost to your company will depend on the number of products that need to comply and your readiness for UDI compliance.

Retaining the ability to export certain medical device types to the US going forward will require manufacturers to conform to this new standard.

Evaluating whether existing systems can be adapted to conform to FDA UDI / DPM requirements and maintain compliance over time also means reviewing data quality.

Initially the UDI will relate to the label and package of the device. However, the FDA will also require manufacturers of certain product types to implement Direct Part Marking (DPM), where the UDI must appear as a permanent marking

ADVERTORIAL

Enhancement

Validation systems will need to be in place to ensure each and every GS1 barcode produced, whether for packaging and/ or for DPM, can be validated at every stage of manufacture and retain appropriate audit trails to meet external regulatory inspections.

And of course, this all takes time-- with the average implementation time across a business of 6 months, there is much to consider with potentially very high stakes. So with the one certainty being that companies must engage on UDI and DPM at an early stage, or risk losing export sales rights to the US marketplace, solutions must come quickly and with high levels of reliability, flexibility and speed of implementation.

A ‘unique’ Unique Device Identification Service For the past several months Kodit Database Limited has been examining the requirements of the FDA UDI law and after discussions with both regulators and manufacturers, has devised a web enabled GS1 compliant UDI solution, built on the Kodit platform, conforming to new FDA UDI labelling standard. The solution will help Medical Device manufacturers to address the challenges the FDA UDI law.

Kodit is working with Swansea University’s Health Cloud project to deliver a pan-Wales, GS1-compliant Unique Device Identifier (UDI) solution. The Health Cloud project is supported by a £240K grant through the Welsh Government’s European-funded Academic Expertise for Business (A4B) programme and is hosted within Swansea University’s Health Informatics Group.

FUTURE WATCH Potential healthcare game changers

Virtually ahead of the rest Sponsored by NHS Education for Scotland, this successful partnership has put Scotland at the forefront of clinical technology and training. Digital designers in Glasgow have created a model of human anatomy which is claimed to be the most accurate in the world.

At its launch, First Minister Alex Salmond described the project as “an excellent example of partnership working, with the clinical expertise of the NHS and University of Glasgow working in tandem with the Digital Design Studio at Glasgow School of Art to produce a truly ground-breaking clinical training tool.”

The computer model has been designed to improve the training of students and clinical trainees

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and it took three years to create, using data gathered by scanning real human bodies. Its construction required the careful dissection of a cadaver, with laser scanning at each stage and includes accurate visualisations of the skeleton, nervous system, blood supply, muscles, supporting tissues and lymphatic drainage. To make the model as realistic as possible, the design team even went into operating theatres to collate accurate information on the colour of various parts of the anatomy.

They then used their expertise to reconstruct the head and neck and to develop software that could manipulate the model.

Director of the Digital Design Studio, Prof Paul Anderson, said that “this provides very safe training in a very dynamic and dramatic way. Our software works with a keyboard and mouse but we can also give someone a games

“

“an excellent example of partnership working, with the clinical expertise of the NHS and University of Glasgow working in tandem with the Digital Design Studio at Glasgow School of Art to produce a truly ground-breaking clinical training tool.”

controller, and they can take that and ‘fly’ into the skull and look around. That’s very exciting. It’s fantastic for learning - it’s providing an unforgettable experience.”

He explained that virtual reality means that various procedures

Future watch Future watch

PICTURES COURTESY OF DIGITAL DESIGN STUDIO

can be repeated without risk. If a student makes a mistake on this model they can fail ‘safely.’ For example, the 3D imagery can be connected to a ‘haptic’ needle, which reproduces the feeling of giving an injection to a patient. It also means that training times for the next generation of doctors and dentists can be greatly shortened.

As well as its obvious potential for medical training, surgeons are also interested in it for day-to-day use as it will allow them to plan and practice difficult operations virtually by overlaying a patient’s data on the model.

“Experienced surgeons can use this to consider how they’re going to approach a particular problem, so it’s got huge potential” said Mr McKerrow, an experienced ear nose and throat surgeon at Raigmore hospital in Inverness.

To enable dental teams and undergraduates to take full advantage of these new educational resources NES has also invested in state of the art 3-D teaching laboratories in, Glasgow, Dundee, Inverness and Stornoway.

Similar laboratories are being developed in Dumfries and Aberdeen to ensure that the 3-D packages are available to an even wider range of students. These allow students to experience a level of 3-D that until now has only been available to professional broadcasters and media, and as all the centres are linked it is possible for a tutor in one centre to lead a lesson with students at multiple centres simultaneously.

This already happens with hygiene/ therapy students in some areas of Scotland and the aim is that eventually students will be able to use it at home on their own games consoles.

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Exceptional Services

World-leading Research

Dynamic Research Environment

Future watch

IT Supporting clinical decisions According to Robert Hayward of the Centre for Health Evidence, “Clinical decision support systems link health observations with health knowledge to influence health choices by clinicians for improved health care.” iQudos report that their clinical decision support software, designed specifically for prostate cancer, is resolving clear clinical needs for large populations of patients in what is potentially a large market. Their system has recently been successfully registered as a medical device in Europe and it allows nonspecialist health care workers to look after men with stable prostate cancer with as little as a morning’s training compared with the traditional two years it takes to train an oncology nurse.

Mike Henley, Medical Director at iQudos and a practising consultant surgeon in Urology for Derby Hospitals Trust, says, “We have spent years training and testing this artificial intelligence software, which enables the management of long term care and stable prostate cancer. We have demonstrated that the system is 10 times safer than human assessment in our clinical studies.

The system is embedded in the NHS; the business has been supported by NHS Innovations Hub and sits within a secure NHS computer network. As the software is modular in construction we are well positioned to both update the system for changes in our understanding of prostate cancers and to introduce this approach into other specialist areas.”

The iQudos team feel they have achieved something of a holy grail by producing an e-Health system which is proven to operate safely, is registered as a medical device and is being used

in clinical practice. The achievement of a registered and operating product gives the opportunity for clinical commissioning groups in the UK to raise the standard of care while achieving significant cost and efficiency savings.

The implications for global healthcare may well be more significant than perceived, with the World Health Organisation highlighting a huge shortage of healthcare workers globally which is only going to get worse as populations age. A way of coping with these healthcare shortages could be the use of IT systems such as iQudos.

Dates for your Diary: April 2/3 2014

100% dedicated to medical device design and manufacturing Ricoh Arena, Coventry 2-3 April 2014

www.mtiexpo-uk.com Watch the video here

+44 (0)845 Supported by

Book your stand today to avoid disappointment, contact 0348901 or events@med-techinnovation.com

Med-Tech Innovation Expo is the largest show for the UK Med-Tech industry

MADE IN THE UK Keeping manufacturing on home turf

Royal approval Exeter-based business Simpleware has been awarded a Queen’s Award for Enterprise – the UK’s highest accolade for business success - for the second year running.

A computer model of the human torso.

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UK Lifescience Industry Magazine

Made in the UK

The company develops software solutions, allowing the generation of computational models of complex objects for which no computer aided designs (CAD) are available. This technology can be applied to structures such as the human body to assist in implant design and biomedical engineering.

Using computerised models of core samples, analyses of the flow of fluids like oil through the rock can be completed.

Not content with the two Queen’s Awards already under their belt, Simpleware was also selected as a winner in the 2013 International Trade category.

Over 90% of sales are export based, with their customer base consisting of a wide range of blue chip companies, leading research institutes and universities worldwide.

Philippe Young, Simpleware’s Founder and Managing Director, commented: “It is excellent news that we have once again received this national recognition, and the award is the icing on the cake after several years of strong growth. The business is continuing to expand and develop, and we are opening a second US office later in the year and plan another office in Germany. Our success as a business is a testament to our excellent team.”

A rock sample model for the analysis of the material’s strength and stiffness.

A finite element mesh of the human heart and lungs ready for simulation.

Representatives from Simpleware will receive the award at a reception hosted by the Queen at Buckingham Palace on 23rd July 2013.

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Current reforms in the NHS bring real risk but also significant opportunity. The changes are numerous, complex, and impact multiple areas of businesses; understanding and responding to their impact is becoming increasingly challenging for industry.

The ABHI MedTech 2013 conference will help companies understand and respond to changes in healthcare structures and delivery processes in a period of financial constriction.

Senior figures from Government, the NHS and industry will provide a comprehensive map of the key issues affecting future success. Delegates will leave the conference with a clear understanding on how to deploy resources, construct value propositions and develop strategic priorities.

Why attend? ● Practical insights into reforms that can be

converted into tactical business plans

● Understand critical strategic trends that will impact

your current and future business plans

● Gain practical benefit from issue focussed

workshops

● Network with senior NHS leaders, Government

officials, and Parliamentarians

● Gain a clear understanding of roles and

responsibilities of the new NHS organisations such as AHSNs, Clinical Senates and Specialised Commissioning

The Conference will have three different content streams- UK Market, Regulatory Policy, International affairs.

UK Market The UK Market stream of the conference will focus on the changes to the NHS and how they will impact on the medical device industry. Across two days the conference will look at a number of areas: procurement, commissioning and innovating at scale, payment systems and the future of health technology evaluation.

Themes covered in detail will include the Procurement Delivery Programme published in August; the strategic priorities of the new clinical commissioners in the NHS and the role of Academic Health Science Networks in scaling up the spread of innovation. Further insight will be provided on the proposed changes to reimbursement mechanisms led by NHS England and Monitor.

Speaker highlights ● Health Minister Dan Poulter will outline the future of NHS

procurement and the impact the ‘National Procurement Delivery Programme’ will have on industry.

● Professor Robert Harris, Director of Strategy NHS England will

give an insight into the strategic imperatives within the NHS.

Regulatory This content stream will look at the revision of the Medical Device Directives, the legislative process for which is due to be completed by May 2014. Delegates will be brought up to date on the latest proposals, with specific focus on the key changes that and how they will affect your business. Day two of the conference will focus on Unique Device Identification and what future requirements for labelling and barcoding will look like for manufacturers.

Speaker highlights ● Jackie Minor, Head of Representation (EU Commission London

Office) will explore the changes to the MDD.

● John Wilkinson, Head of Devices, MHRA, will discuss how the

MHRA will implement the changes to the MDD.

International The international content stream will explore changing global healthcare demand and provide a glimpse into what will happen in future helping inform your future international market strategy.

Understanding future healthcare demand, its drivers and understanding routes to market, accessibility and market prioritisation are key to ensuring international business success.

This session will also cover the Bribery Act and how you can protect your company and employees operating abroad. This stream will also provide hands-on practical advice to companies seeking to navigate international regulatory regimes.

Speaker highlights ● Earl Howe, Parliamentary Undersecretary of State for Health,

Department of Health Global Healthcare - UKs Strengths and importance of exports

● Cabinet Minister Ken Clark, will update on the UK’s

Government’s international priorities.

Event Details Date: 15 and 16 October 2013 Venue: Mermaid Theatre, central London (EC4V 3DB)

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Two day Rate: £495 for ABHI members, £650 for non-members.

Association of British Healthcare Industries

One day rate: £295 for ABHI members, £395for non-members.

UK Lifescience Magazine

Visit- www.abhi.org.uk for more details and information on how to book

Made in the UK

Seeing is believing A founder member of the Institute of Ocular Prosthetics in the UK, John Pacey Lowrie is something of a perfectionist.

For 36 years he has been making bespoke ocular prosthetics, constantly keeping up with improvements in materials and technology to make his artificial eyes as realistic as possible.

However there was one thing which he found a continual frustration; while his prosthetics could move convincingly, he was not able to simulate the very thing which makes eyes “the window of the soul”, that is the dilation and contraction of the pupils in reaction to light.

place a prototype prosthetic eye which dilates and contracts as required. A “Future Factory” grant is in process through the university which will hopefully lead to improvements so that the product can become a working bespoke ocular prosthetic which could be on the market in close to 18 months’ time.

Ever the perfectionist, John is not satisfied with progress yet.

Different people will have different dilation and contraction patterns

depending on their age, health and lifestyle. John’s vision is for the creation of a computer model which will allow him to tailor the reaction of the eye to the individual, giving them the confidence that their prosthetic is as lifelike as modern technology can provide.

This drive for perfection continues and John has found that the route to excellence in the future is collaboration and partnership with those at the forefront of materials and technology science.

Three years ago John engaged with the Healthcare and Bioscience iNet run by Medilink East Midlands who put him in touch with Dr Phil Breedon-a specialist in smart materials science at Nottingham Trent University. In the discussions which followed they realised that the image of a dilating and contracting pupil could be recreated through the use of electroactive polymer technology.

With the help of a Master’s student at the university, John now has in

Visit www.johnpaceylowrie.com for more information

Future Factory: Future Factory is part-funded by the European Regional Development Fund. It supports small and medium sized businesses (SMEs) in the East Midlands to become more sustainable in their product design processes. The Future Factory project offers up to 90% of the funding needed to realise a collaborative project. It can also help with funding a 25% subsidy of the cost of employing a recent graduate for up to one year. No minimum or maximum funding values are specified.

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UK Lifescience Industry Magazine

Great British Research volume of applied health research for the benefit of patients and the public, driven faster translation of basic science discoveries into tangible benefits for patients and the economy, and developed and supported the people who conduct and contribute to applied health research. The NIHR plays a key role in the Government’s strategy for economic growth, attracting investment by the life science industries through its world-class infrastructure for health research.

Together, the NIHR people, programmes, centres of excellence and systems represent the most integrated health research system in the world.

The National Institute for Health Research The National Institute for Health Research (NIHR) is funded by the Department of Health to improve the health and wealth of the nation through research. Since its establishment in April 2006, the NIHR has transformed research in the NHS. It has increased the

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UK Lifescience Industry Magazine

The mission of the National Institute for Health Research (NIHR) is to maintain a health research system in which the NHS supports outstanding individuals, working in world class

facilities, conducting leading edge research focused on the needs of patients and the public.

Professor Dame Sally Davies, as the head of DH R&D, is responsible for NIHR and the Advisory Board provides strategic advice on its direction, implementation and management .

Since its establishment in April 2006, the NIHR has worked with key partners involved in the different elements of NHS research to transform research in the NHS. It has increased the volume of applied health research for the benefit of patients and the public, driven faster translation of basic science discoveries into tangible benefits for patients and the economy and developed and supported the people who conduct and contribute to applied health research.

Made in the UK

The Institute manages its activities through four main work strands: l NIHR Faculty: supporting the individuals carrying out and participating in research l NIHR Research: commissioning and funding research l NIHR Infrastructure: providing the facilities for a thriving research environment l NIHR Systems: creating unified, streamlined and simple systems for managing research and its outputs.

National Institute for Health Research Room 132 Richmond House 79 Whitehall London SW1A 2NS www.nihr.ac.uk enquiries@nihr.ac.uk

Health Research Wales Health Research Wales has been established to provide a one-stop source of information and support for companies wishing to undertake clinical research in Wales. Their mission is to facilitate the successful delivery of commercial research in the NHS and promote Wales as an effective place to do research.

A dedicated team, working across Wales, has been put in place to ensure the delivery of a high quality and professional service. They work closely with the NHS Research and Development (R&D) teams and are able to provide advice and support for the establishment and management of studies. Health Research Wales‘ services include general signposting, a partnering service, costing advice and support,

feasibility co-ordination, contracts advice and support and support in study set-up and management.

Wales has a vibrant research culture involving the NHS, industry and academia which has been established to bring benefits to patients in the immediate term, as well as providing long term solutions to diseases. Many important initiatives have been undertaken to streamline the processes for undertaking studies, making Wales an attractive proposition to industry.

The integrated Welsh NHS also provides an excellent basis for research and innovation and, has the potential to play a significant role in creating better therapies and technologies that will bring immediate benefits to patients.

Health Research Wales aims to enhance the research environment, contribute greatly to improved care for patients and improved health and wealth for the population of Wales and those who decide to invest in it.

2nd Floor, 12 Cathedral Road Cardiff CF11 9LJ +44 (0) 29 20 230 457 www.healthresearchwales.com contact@healthresearchwales.com

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UK Lifescience Industry Magazine

Its vision is to ‘promote and enhance Scotland as a world-leading hub of innovative health research and development.’

Its objectives are: l To increase the level and quality of health research and development in Scotland l To improve and facilitate collaborative and innovative early phase clinical trials between academic and industry partners l To support NHS Research Scotland (NRS) to deliver highquality clinical trials in a rapid, efficient and timely manner.

Health Science Scotland Health Science Scotland was formed several years ago (previously called Scottish Academic Health Science Collaboration) as a partnership of medical universities and their associated NHS Health Boards in Scotland to promote excellence in the field of clinical and translational medicine. It is supported by Scottish Enterprise, the main economic development agency for Scotland, including its international development arm – Scotland Development International.

Health Science Scotland brings together the most senior figures from across Government, academia and the National Health Service and provides an operating structure that reaches across researchers in a wide range of disciplines, has access to all tiers of care, and can address virtually all of the chronic diseases that afflict developed countries.

l To increase the number of Scottish patients participating in and benefiting from clinical research l To increase the speed and adoption of high quality clinical and health improvements l To generate sustainable economic benefit to Scotland.

Health Science Scotland undertakes a range of activities to promote and enhance Scotland as a world-leading hub of innovative health research and development.’

Although not exclusively, the main activities are: l Health Science Scotland Action Group. Bringing together the most senior researchers and expertise in Scotland to identify the most appropriate and skilled researcher to work with potential research funders. This will typically lead to the development of specific research proposals to meet customer needs.

l Promotion of Scotland’s excellence and expertise.

Through a range of mechanisms including one to one meetings, attending conferences and most importantly supporting the internationally respected academics to help raise awareness and understanding of the extent of Scotland’s expertise and its abilities l Support the development and promotion of the Scottish health science sector. Assisting to develop and deliver innovative clinical and translational research solutions Health Science Scotland has been established to act as a portal to health research funders and is charged with providing a first point of contact for all customers and ensuring that they receive the most professional and quality response to meet their research needs. Health Science Scotland will: l Identify the most appropriate researcher to meet your research need l Work with lead researchers and their institutions to ensure that responses to any enquiries as well as any funding proposals and bids are completed within the timescales required l Ensure that the contractual and permissions process is delivered professionally and efficiently.

Health Science Scotland West Medical Building University Avenue Glasgow G12 8QQ +44 (0)141 330 7769 www.healthsciencescotland.com collaborate@healthsciencescotland.com Graeme Boyle, Senior Programme Manager: g.boyle@healthsciencescotland.com Diana Morgan, Industry Liaison Manager: d.morgan@healthsciencescotland.com

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UK Lifescience Industry Magazine

Made in the UK

Edgbaston on the global stage Edgbaston Medical Quarter is set to catapult the Birmingham district into the international spotlight. Officially launched at the inaugural Life Science Summit 2013, the Quarter will provide a global platform for world-class medical and healthcare provision in the district, as well as offering collaborative and commercial opportunities for businesses.

The Quarter will be managed and promoted by life science specialist Medilink West Midlands. Tony Jones, Medilink’s CEO, believes the area’s strong legacy of innovative healthcare will benefit from the new initiative, commenting: “This district offers a powerful combination of academia, clinicians and industry, all of whom are committed to

working collaboratively to drive farreaching innovation. Techniques, devices and services created within the Edgbaston Medical Quarter over the last decades have changed medical procedures across the world, dramatically improving patient care and outcomes. With the creation of the Edgbaston Medical Quarter we will be promoting this expertise to a global audience, encouraging inward investment and commercial growth.”

Edgbaston’s existing medical cluster consists of more than three hundred medical and life science organisations. It is hoped that the promotion of this international centre for medical excellence will attract world leading healthcare professionals to the region and provide a valuable platform for the exchange of knowledge and resources.

“As a business that delivers services to healthcare professionals and providers, we are keen to maximise the collaborative opportunities available within the Edgbaston Medical Quarter” added Richard Barnes, managing director of local company Select Research. “I have no doubt that the creation of Edgbaston Medical Quarter will provide a global platform for our revolutionary work.”

To find out more visit: www.emq.org.uk

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Time’s up for Healthcare Associated Infections A North West-based supplier of ultra high purity peptides and liposomes, Advanced Biomedical Ltd, is leading the battle to reduce Healthcare Associated Infections (HCAIs).

The control of HCAIs and the improvement of cleanliness of hospitals and also other areas such as care homes has been a primary objective not only of the Department of Health and the NHS, but increasingly worldwide. Current estimates place the cost of HCAIs in the NHS alone at approximately £1billion a year.

According to a 2012 NICE (National Institute of Clinical Guidelines) report, it is estimated that 300,000 patients a year in England acquire a HCAI as a result of care within the NHS. In 2007, MRSA (Meticillin-Resistant Staphylococcus Aureus) bloodstream infections and C. difficile (Clostridium difficile) infections were recorded as the underlying cause of, or a contributory factor in, approximately 9,000 deaths

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in hospital and primary care in England.

Advanced Biomedical Ltd (ABL) is now leading the battle to reduce HCAIs following the completion of an SBRI HcAI innovation call from the TSB (Technology Strategy Board). Dr Harmesh Aojula, ABL’s Managing Director, has developed an innovative Medical Device that dramatically speeds up the process of identifying infected surfaces within healthcare settings.

Current conventional laboratory tests take about three days to confirm whether a surface was colonised with an HcAI. ABL’s innovation is now able to ascertain MRSA and C. difficile contamination within 15 minutes. The device, which can be easily transported by infection control staff to any

desired location, requires only a short procedure prior to providing a positive or negative reading.

The hand held device utilises magnified images of fluorescent microspots to determine infectious disease.

With the successful completion of the SBRI project, ABL is now looking at the commercial aspects of the business with further innovation already in the pipeline.

“

“Developing a reagent to detect endospores with high sensitivity has been a difficult challenge. At the heart of the technology is a glow reagent to illuminate potentially viable endospores from within its nanocore compartments.

This, combined with a special detector device and the prospect to rapidly image and quantify an infection risk, is exactly the solution required in healthcare settings.”

Dr Harmesh Aojula, Managing Director, ABL

10th December 2013 The UK HealthTech Conference is to be held at the Hilton Hotel, Cardiff

Would you like to be a part of the UK Life Science Industry Conference?

The event will be a valuable day of briefings and networking for those within the life science and health technology communities.

Over 250 delegates are expected to come together to understand critical strategic trends that will impact on their businesses, receive the latest insights from key opinion leaders and network with clinical researchers and senior NHS and industry stakeholders.

Register to attend www.ukhealthtech.com

For more information please email: lucinda@uklifescienceindustry.com

029 2047 3456

Keynote speakers: • • • •

Richard de Souza, CEO, Martindale Pharma Tom Pellereau, Aventom, “The Apprentice Winner 2011” Dr Stephen Minger, GE Healthcare Professor Keith Harding CBE, Wound Healing Research Unit, Cardiff University

Plenary topics are set to include:

Seminar topics are set to include:

• • • •

• • • • •

Regenerative medicine Wound healing Diagnostics The future of the life science and health technology sectors in the UK - panel discussion

SUPPORTED BY:

UK Procurement Landscape MHRA and Regulatory Framework Changes Grants for SMEs - EU Horizon 2020 NICE Medical Technology Briefings Funding from the Technology Strategy Board and the Biocatalyst Programme Knowledge Transfer Network HealthTech and Medicines

DELIVERED BY:

MEETING THE UNMET Responding to unmet clinical needs

National centres for woundcare launched England

Pioneering treatments that could change the face of woundcare may soon be discovered thanks to newly-launched national centres for excellence across the UK in woundcare research.

Funded by the National Institute for Health Research (NIHR), the NIHR Wound Prevention and Treatment Healthcare Technology Co-operative (HTC) is one of eight new HTCs being launched across England with the aim of fostering innovation in areas of unmet need across the next four years.

Around 100 delegates attended the launch event which was also used as an opportunity for business managers, technology developers, clinicians, academics and other stakeholders to voice the challenges they see in wound management.

The event was set against the backdrop of woundcare treatments which are currently costing the NHS in England an estimated £3.1 billion per year and the focus was placed on discovering current challenges in woundcare and coming up with potential solutions to them.

Professor Vowden, Clinical Director of the NIHR Wound Prevention and Treatment HTC and a worldrenowned woundcare expert said “The NIHR Wound Prevention and Treatment HTC will look at medical device innovations that are patient led and focused – and the NHS will be a partner for delivery and adoption of new device technology.

“The HTC is very much a national institution with specialisms in product development, clinical trials, cell biology and research and patient focused trials – all of which provide a range of expertise that will support innovation.”

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Carole Bennett, a speaker at the event and member of the Pressure Ulcer Research Service User Network, who has Multiple Sclerosis, told the delegation how she had cared for her mother who had also suffered with the condition, and how pressure ulcers had been a major issue for her.

She said, “I am a member of the MS Society’s Research Network and also the Pressure Ulcer Research Service User Network – and we have discovered that solutions must be patient focused. What I hear patients and carers say is that what we want is not always what researchers think we want.

“For me, that this HTC is patient focused is really important in helping them (patients) get their lives back.”

Wales In Wales, a new £4million national centre of excellence in wound prevention and treatment is to be established with the dual aim of delivering health and wealth benefits for people in Wales.

The Welsh Wound Innovation Centre will have a strong commercial focus on job creation and business as well as delivering a full range of clinical research and knowledge transfer services to NHS and commercial customers.

The announcement was made

by Edwina Hart, Minister for the Economy, Science and Transport, when she addressed delegates attending BioWales 2013 where the theme was the future of healthcare.

The Minister said, “The Welsh Wound Innovation Centre provides us with a real opportunity to excel in this area. Wales has the expertise to provide a solution and the capability to become a world recognised leading nation in this important clinical area.

“Wound healing is a niche speciality identified by the Life Sciences Sector Panel and in our Science for Wales strategy as an area of genuine excellence for Wales.

“We have acknowledged global leaders in the field working here in Wales as well as a strong network which links the business, clinical and academic communities. The Welsh Wound Innovation Centre will build on this firm foundation.”

The collaboration will, she said, promote the reputation of Wales in this specific area and support the development of innovative business clusters.

Funding for the centre comes from the Welsh Government, all seven local Health Boards and the private sector, with the aim of becoming self-financing within three years, via revenue from academic grants; clinical service and commercial sources. Over its first five years the centre aims to deliver at least eleven inward investments to create a business cluster and up to 45 new jobs;, attracting external revenue to fund clinical research and to pay for other contract and commercial activities.

Dr Andrew Goodall, Chief Executive, Aneurin Bevan Health Board, said: “The NHS in Wales is pleased to be a key partner and founder of the new WWIC. In challenging financial times, we need to retain an approach which rewards research and innovation.

“This is an important development that brings together government, a university perspective and the NHS. It builds on existing work in Wales which has an international reputation for wound healing to bring health benefits and subsequent financial savings.”

The Welsh Wound Innovation Centre team, led by Professor Keith Harding CBE, Head of the Wound Healing Research Unit at Cardiff University, has already had encouraging in-principle discussions with a number of businesses, relating to partnerships as well as co-location within the Wound Innovation Centre. These include some companies already based in

Meeting the unmet

Wales, as well as a number of large multinationals and potential first-time inward investors.

On the healthcare side, the Wales Wound Innovation Centre will improve management and delivery of wound prevention and treatment, enhancing quality of life for patients through better diagnosis and treatment outcomes, resulting in fewer hospital admissions and shorter hospital stays, and reduce healthcare costs for the NHS Wales LHBs. Professor Harding, commented, “The new centre will act as a focus for research, clinical and commercial excellence in wound prevention and treatment.

This will position Wales in a global leadership position in addressing this growing healthcare issue.”

Cedar: Cardiff-based medical device research specialists Cedar is a healthcare technologies research centre led by Director Dr Grace Carolan-Rees and based in Cardiff Medicentre. Established in 1977, it is a combined Cardiff and Vale University Health Board and Cardiff University group, specialising in medical devices and diagnostics. The team are experienced in a range of methods including systematic reviewing, health economics, technical testing, statistical analysis, and questionnaire design and validation.

Cedar is an external assessment centre for the National Institute for Health and Care Excellence (NICE) working since 2010 on the Medical Technologies Evaluation Programme (MTEP). MTEP evaluates new or innovative devices and diagnostics, helping the NHS adopt efficient and cost effective medical technologies more rapidly and consistently.

Cedar, in partnership with the Cardiff Wound Healing Research Unit led

by Professor Keith G Harding (CBE), is currently running the first clinical trial resulting from NICE medical technology guidance recommendations.

The trial investigates whether an innovative wound healing technology, the MIST ultrasound therapy system (Celleration, US), is better than standard care in promoting healing of chronic venous leg ulcers. This study is a collaboration between Cardiff and Vale University Health Board and Cardiff University, funded through an unrestricted research grant from the device manufacturer. The randomised controlled trial aims to fill the evidence gap identified in NICE’s medical technologies guidance on MIST. Following completion of the study in Autumn 2013 NICE will review its medical technologies guidance on MIST when new and substantive evidence becomes available.

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Big push for battlefield haemostat MedTrade launches fastest acting battlefield haemostat MedTrade Products Ltd, developers of a range of advanced wound care products, has announced the European launch of Celox™ Rapid.

The fastest haemostat on the market, Celox™ Rapid has been developed with unique, patented technology, in response to the real needs of battlefield medics and represents the next stage in not only the development of the original Celox™, which is already standard issue for the UK military, but sets a new standard for haemostatic agents/control.

In combat scenarios, time is very much of the essence in cases of severe bleeding caused by gunshot wounds or explosions. The injured soldier has to be treated and evacuated from the scene as fast as possible; even a matter of minutes can be too long. Celox™ Rapid can control the most serious, life-threatening bleeding with just 60 seconds compression.

Easily carried in a slim-line pack, Celox™ Rapid comes in a strip of Z-fold gauze onto which Celox™ granules and Chito-R are bonded. The Chito-R, one of the

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distinguishing features of Celox™ Rapid, creates a unique adhesion (wet stick) to the source of the bleeding and works with the Chitosan already in the Celox™ to create a gel-like plug that stops the bleeding faster than any other treatment.

The Celox™ blood clotting technology was first developed

by MedTrade precisely for the purpose of dealing with battlefield wounds and has been tried and tested in both Afghanistan and Iraq.

Working independently of the body’s normal clotting processes, Celox™ generates no heat and does not burn the casualty or care giver. It has also been proven effective in situations where the blood does not clot normally, for example in cases of shock-induced hypothermia and in the presence of common anticoagulants such as warfarin.

Chris Marsden, Head of Marketing for Celox, said: “Speed is absolutely paramount in casualty care and Celox Rapid offers a radical change in the ability to deliver fast, effective treatment.

“Celox Rapid has had a great reception in the US and is already generating a huge amount of interest since its launch in Europe. We are very proud to support NATO troops and the emergency services with this new development.”

For further details on Celox™ Rapid, visit ww.celoxmedical.com

Meeting the unmet

Pushing the boundaries of infection control An exciting aspect of the development of the UK’s ever expanding life science sector is the extent to which expertise and technology from other sectors are being harnessed and applied to life science. One of the latest companies to develop a new life science division is B & V Group, originally established in 1977 to provide technically advanced water treatment products.

The new B & V Life Sciences division still has a strong element of water disinfection expertise but is also developing wound care products at its ISO 13485 certified production plant. Waterborne microbes remain a significant concern within the health care environment and key problematic organisms are legionella species, which can

Bacterial colonies of Pseudomonas aeruginosa grow on agar plate

cause Legionnaires’ Disease and pseudomonas aeruginosa which can cause skin and lung infections.

Vulnerable patients such as those with cystic fibrosis are at particular risk and pseudomonas infections are relatively common, with around 4000 cases reported to the Health Protection Agency per year. Legionnaires’ Disease has a fatality rate approaching 50% for nosocomial infections. B & V Life Sciences has developed technology, and has the application expertise, to significantly reduce the risk from harmful microbes such as pseudomonas and legionella bacteria. New generation

products such as Abulox are being used widely in the healthcare environment, including many high profile NHS hospitals where the combination of efficacy, ease of use, simple application with advanced monitoring ensures bacterial control.

Alongside the constant innovation of new products B & V Group has also established a Training Academy, which is the first approved training provider to offer one-day Ofqual accredited courses on legionella control. The increasing impact of regulation means that formal qualifications on compliance need to be developed for those working in the NHS and facilities management and the B & V Training Academy delivers courses for such specialist areas.

The movement into woundcare is a natural progression for a company which is an expert in disinfection and a leader in innovation. B & V Group remain at the forefront of infection control. The new B & V Life Sciences division will be focusing its expertise on developing new approaches utilising its core expertise. The challenge for the normally conservative health sector will be to encourage fast adoption

of the new water disinfection and woundcare products to ensure that the best available technology is being applied to their efforts to combat infection.

www.bvwater.co.uk

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Devices for Dignity A new national healthcare centre to preserve the dignity and independence for people living with long-term conditions has been launched.

Funded by the National Institute for Health Research (NIHR), the NIHR Devices for Dignity Healthcare Technology Co-operative (HTC) was launched at the NHS Innovation Expo in London.

NIHR Devices for Dignity HTC, one of eight new HTCs launched across the country, will drive forward innovative new products, processes and services in three main areas of unmet clinical need: Urinary Continence Management, Renal Technologies, and Assistive and Rehabilitative Technologies. In addition to this, it also offers a full range of professional services, including clinical engineering, prototyping, regulatory advice, health economics, market analysis, grant writing and IP management.

The NHS Expo enabled this HTC to build further relationships with other NHS trusts and increase knowledge among potential partners. It provided a platform on which it could showcase some of the leading products and services it has already helped to support from its three clinical focus areas.

The co-operative initially began five years ago as one of two pilot schemes in the country, and was recently unveiled as a fully funded HTC and will receive funding for the next four years after a successful submission.

Professor Wendy Tindale, Clinical Director for NIHR Devices for Dignity HTC, said, “We are delighted to be receiving further funding from the NIHR to become an HTC. “We are proud of the work we have already completed as a pilot scheme and of our commitment to working in partnership, which is helping us to translate research and innovation to the person’s bedside – at home or in a hospital.

“Working alongside our partners, we aim to build on our successes and become recognised as the national expert group in dignity-related unmet needs, by providing new medical technologies and inventions to help patients maintain dignity and improve their quality of life.”

www.devicesfordignity.org.uk

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Important dates for the diary October 15-16

ABHI: The MedTech Conference, London

December 10

UK HealthTech, Cardiff

December 12

Genesis, London

March 6-7

BioWales 2014, Cardiff, Wales

April 2-3

Med-Tech Innovation Expo, Coventry

UK Lifescience Industry EVENT CALENDAR 2013-2014 December

October 2 2

Biomat- IN SIG 5: Biomaterials in Cardiovascular Applications, Aachen, Germany

8

Welsh Wound Network Open Meeting, Wrexham, Wales

9

Medilink North West: New Medical Device Regulations, Stockport

10-11

Healthy, Happy, Fairer Communities: Welsh Public Health Conference 2013, Cardiff

15

Medilink East Midlands: Are you ruining your suppliers’ performance? Nottingham

15-16

4-6 5

11-13 13

ABHI and Medilink North West: AHSN Industry Contact Event - NHS Adoption and Spread, Manchester

30

KTN: Getting the product to the patient, Loughborough, KTN

30

Ausbiotech, Australia Medilink East Midlands: Medical Technologies Evaluation at NICE Nottingham

November BIO Europe Vienna, Austria Medilink West Midlands: The Perfect Pitch: The Art of Tendering for Public Sector Business, Birmingham Medilink UK: Technological Innovations in Mental Healthcare, MindTech HTC launch, London BIO China Convention, Beijing, China ABHI/ Life Sciences Scotland/ Medilink UK: Trends in Medical Technologies, Glasgow, Scotland

13-14

MDI 2013 - Medical Device Innovation Conference, Paris, France

20-23

Medica (Welsh Government Mission), DĂźsseldorf, Germany

21 27 27 28

8-11 9-13 10 10 12

Medilink East Midlands: Horizon 2020 Regional Information Day, Nottingham Medilink East Midlands: Healthcare Biomaterials SIG 1launch, Nottingham Medilink Yorkshire and Humber and 54 Degrees: Successful Presentations and Public Speaking, Sheffield Medilink East Midlands: Export Documentation for Life Sciences, Nottingham

Medilink East Midlands: Asia Pacific Lifescience Clinics, Nottingham BIO Pacific Rim Summit, San Diego, California Zdravo 2013- Healthcare Conference, Moscow, Russia UK HealthTech Conference, Cardiff MediWales Annual Innovation Awards Dinner 2013, Cardiff Genesis, London

January

ABHI: The MedTech Conference, London

22

31

11

4

IPH Open Conference 2013, Dublin, Ireland

8

HealthTech and Medicines KTN: Biopharmaceutical Innovation- A Vision for the Future: 10th Annual bioProcessUK conference, London

3-4

Horizon 2020 for Health, London, KTN

16

Medilink Yorkshire and Humber: Healthcare Business Awards 2013, Leeds

23

MediWales/KTN: Clinical Unmet Needs, Cardiff

27-30

Arab Health Exhibition and Conference (Welsh Government Mission), Dubai, UAE

February 1-6

UKTI: Medicon Valley (Welsh Government Mission), Malmo/Stockholm, Sweden

3-7

UKTI: Oncology Mission, Tokyo, Japan

6

Life Sciences Scotland Partnering and Funding Event, Edinburgh, Scotland

March 3-4

NHS Innovation Expo, Manchester

6-7

BioWales 2014, Cardiff, Wales

2-3 8-9

April Med-Tech Innovation Expo, Coventry BIO Asia, Tokyo, Japan

May 6-8 19-21

Africa Health, Johannesburg, South Africa

20-23

Hospitalar, Sao Paulo, Brazil

Saudi Health, KSA

June 11 23-26 25-26

Innovation Day 2014, Leicester BIO International Convention, San Diego, California Med-Tech Innovation Ireland, Athlone, Ireland

MedilinkUK

working together to raise the profile of the life science industry in the United Kingdom

UK Lifescience Industry Magazine Partners Medilink UK Member Organisations Medilink East Midlands BioCity Nottingham Pennyfoot Street Nottingham NG1 1GF Tel: +44 (0)115 912 4330 info@medilinkem.com www.medilinkem.com

MediWales 7 Schooner Way Atlantic Wharf Cardiff CF10 4DZ Tel: 029 2047 3456 info@mediwales.com www.mediwales.com

HealthTech and Medicines KTN c/o TWI Ltd Granta Park Great Abingdon Cambridge CB1 6AL Tel: +44(0) 1223 899 000 www.innovateuk.org/healthktn

Medilink North West Suite 1 5th Floor Kingsgate Stockport SK4 1LW Tel: +44 (0)161 477 7785 jamie.gill@medilinknorthwest.co.uk www.medilinknorthwest.co.uk

Medilink Yorkshire and Humber 3 Smithy Wood Drive Smithy Wood Business Park Sheffield S35 1QN Tel: +44 (0)114 232 9292 connect@medilink.co.uk www.medilink.co.uk

Life Sciences Scotland c/o SDI 5 Atlantic Quay 150 Broomielaw Glasgow G2 8LU Tel: +44 (0)141 228 2828 lifesciences@scotent.co.uk www.lifesciencesscotland.com www.sdi.co.uk

Medilink South West Bristol and Bath Science Park Dirac Crescent Emersons Green Bristol BS16 7FR Tel +44 (0)117 230 0459 info@medilinksw.com www.medilinksw.com Medilink West Midlands 4 Greenfield Crescent Edgbaston Birmingham B15 3BE Tel: +44 (0)121 452 5630 enquiries@medilinkwm.co.uk www.medilinkwm.co.uk

6

South East Health Technologies Alliance Tanglewood Well Street Loose Maidstone Kent ME15 0QF Tel: +44 (0)7833 224661 info@sehta.co.uk www.sehta.co.uk

UK Trade & Investment 1 Victoria Street London SW1H 0ET Tel: +44 (0)20 7215 5000 www.ukti.gov.uk

Partner Organisations Association of British Healthcare Industries 250 Waterloo Road London SE1 8RD Tel: +44 (0)20 7960 4360 enquiries@abhi.org.uk www.abhi.org.uk

UK Lifescience Industry Magazine

www.medilinkuk.co.uk