UK Lifescience magazine Issue 7

Issue 7

United Kingdom

Advances in health technology

INDUSTRY

Scoping the landscape of the life science sector AHSNs

Open for business

Obsolescence management Planning ahead for changing technology

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 Going Global: Cracking global markets

7

2014 Medilink UK Awards ďŹ nalists inside UK Lifescience Industry Magazine

Life science is in our blood

“

A message from the chairman of Medilink UK

A new head for Medilink UK

Life science branding is

2012 ISSUE 4

Gary Stapleton, Business Director of 3M Health Issue 5 Business Group, West Europe, has been Care 2012 ISSUE 4 appointed as Chairman of Medilink UK.

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 improve yourJess message Fisherand Editor create brands to get your Jess Fisher Editor blood pumping.

Issue 5

Issue 5

Mr Stapleton, who becomes the first external industry chair of Medilink UK, will lead his first major task when he chairs a meeting to agree a new three year strategy for Medilink UK.

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conduit in ensuring the success of this sector over

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Ut enim ad minim veniam, quis nostrud Chairman, Medilink velit esse cillum dolore eu fugiat nulla UK pariatur. Excepteur orem ipsum dolor aute irure dolor in reprehenderit exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. sit amet, consectetur adipisicing elit, sed do eiusmod tempor incididuntDuis ut fugiat nulla pariatur. Excepteur s aute irure dolor in reprehenderit in voluptate velit esse cillum dolore labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrudeu fugiat nulla pariatur. occaecat cupidatat nonconsequat. proident, sunt exercitation ullamco Excepteur laboris nisisint ut aliquip ex ea commodo Duisin

Gary Stapleton

aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in PUBLISHED IN PARTNERSHIP WITH

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Excepteur sint occaecat cupidatat non proident, sunt in Dargavel

Strength and Opportunities

14

Medilink UK AWARD Nominees

18

Editor

Obsolescence management

Managing risk and minimising disruption

PUBLISHED FOR

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

Fisher © MediWales Ltd. 2014

jess@uklifescienceindustry.com

43 UK Lifescience Industry Event Calendar

Going Global Data obtained

ines artment for Bus ernment’s Dep

from the UK Gov

28 Sweet answers for wound care 29 British companies look to growing African health care market 31 Quadralene takes on the US 31 Exports double for Cornish consultancy 32 Introduction to clinical trials in Latin America

Made in the UK 34 Mediplus celebrates Queen’s Award 34 Virtual Health wins virtual office in the US 35 Speedy Breedy speeds up testing

Meeting the unmet 36 B & V Group broadens horizons 39 CYPs herald faster drug discovery 40 Insight for all 41 SoundSpace Online: a new initiative at The Ear Foundation

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

www.medilinkuk.com

Academic Health Science NetworksOpen for business Issue 5 of UK LifeScience Industry examined the opportunities created by the establishment of the long promised Academic Health Science Networks (AHSNs) across England. In May 2013 NHS England confirmed the designation of the 15 licensed AHSNs and since then the infrastructure and operations required to deliver on their approved plans have been set up.

Gwyn Tudor takes a look at what has been achieved.

There are almost 5,000 health technology companies across the UK each of which understands the importance of close engagement with clinical academics and healthcare providers. From the identification of unmet clinical needs, through product development, evaluation, and as the end user of their products, the clinical community is an essential partner in health technology innovation. The UK NHS is one of the world’s largest healthcare providers; it spends over £140bn on healthcare each year, which represents around 9.6% of UK gross domestic product. The NHS is both a key component of the national economy and a significant commercial partner, collaborator and opportunity for health technology companies.

In 2008, Lord Ara Darzi produced the influential report for the Department of Health High Quality Care for All. The report focused upon concerns that the NHS was poor at innovating and it stressed the need for innovation in order to “enable pioneering new treatments and models of care to be developed and then delivered directly to patients”. He highlighted the role that a partnership between the NHS, universities and industry would play in achieving this goal.

4

UK Lifescience Industry Magazine

Sir David Nicholson’s 2011 report, Innovation, Health and Wealth, built on these recommendations and stressed the importance of the Life Science and Healthcare sectors to the generation of new economic growth. It then went on to recommend the creation of the Academic Health Science Networks.

The 15 licensed AHSNs, covering every part of England, are now operational. Some are led by a single institution while others are managed by wider ranging consortia. All NHS organisations are expected to be affiliated with an AHSN and in this sense the AHSNs together will act as a ‘network of networks’ across the NHS, academia, industry and other major stakeholders. Medilink UK partners in England (Medilink Y&H, Medilink West Midlands, Medilink East Midlands, Medilink South West and SEHTA) are all forming links with the AHSN’s in their regions, ranging from formal agreements to close collaborations.

These links will provide companies with a new route which will allow them to engage with and collaborate with the new networks.

Lars Sundstrom, Director of Enterprise and Translation at West of England Academic Health Science Network

AHSN Core Objectives 1

to focus on the needs of patients and local populations: support and work in partnership with commissioners and public health bodies to identify and address unmet medical needs, whilst promoting health equality and best practice.

2 to build a culture of partnership and collaboration: promote inclusivity, partnership and collaboration to consider and address local, regional and national priorities.

3 to speed up adoption of innovation into practice to improve clinical outcomes and patient experience – support the identification and more rapid spread of research and innovation at pace and scale to improve patient care and local population health.

4 to create wealth through codevelopment, testing, evaluation and early adoption and spread of new products and services

AHSN Key Functions l Research participation l Translating research and learning into practice l Education and training l Service improvement l Information l Wealth creation

AHSNâ&#x20AC;&#x2122;s

North East and North Cumbria North West Coast Greater Manchester Yorkshire & Humber East Midlands West Midlands Eastern West of England Imperial UCL Partners South London Oxford Kent, Surrey and Sussex Wessex South West Peninsula

Contact points for the rest of the UK

Leicestershire

www.healthsciencescotland.com www.healthresearchwales.com www.biobusinessltd.org

Somerset

Devon

;;;

UCL Partners AHSN

5

UK Lifescience Industry Magazine

explains that “the AHSNs will play an important role in the NHS’s engagement with industry. Large corporations can work with the AHSNs alongside groups of SMEs to provide complete solutions to community needs. AHSNs can match technology companies with the right clinicians, evaluate project outcomes and provide clinical evidence.” He stressed that “AHSNs are not a route to fund companies but that they can help to get products into commissioning.”

Beyond the four common core objectives and the six key functions the 15 AHSNs are intentionally very different. Each one focuses on the different clinical priorities which reflect the needs of their regions and the strengths of their organisations.

The creation of AHSNs is an English initiative with regional delivery: Scotland, Wales and Northern Ireland each have their own approach to the

“

David Parry, Chief Executive of South East Health Technologies Alliance (SEHTA) explains that “a regional approach allows the AHSNs to address specific local needs and priorities. Allowing for an in-depth approach to conditions such as dementia; to understand the issue from a clinical and industry perspective; to ‘co-develop’ the best possible solutions; and to create the opportunity for products and services to be properly evaluated for adoption or further investment. The AHSN includes all of the partners required to deliver real change in healthcare delivery.”

challenge of bringing academic, clinical and industry stakeholders together to address healthcare innovation.

Companies tend to focus on specific clinical or technical specialisations and for this reason, companies across the UK, including the devolved areas, would be well advised to seek out and engage with the AHSNs whose clinical priorities fit with their own products and future plans as well as engaging with their local Network.

The establishment of the AHSNs is a bold step in addressing the need to transform service delivery through innovation and the adoption of new technologies. Success in this mission will require the strategic participation of the UK life science business community. While the name AHSN may be a lost opportunity to demonstrate that this partnership is at the heart of NHS thinking, early moves to integrate industry with many of the new AHSNs do suggest a very positive start.

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Others

Obesity & Mental Health

Enhanced Recovery, Pneumonia, Acute Kidney Injury, Preventable Emergency, Community Acquired, Patient Safety Obesity & Mental Health

Wealth Creation and innovation

6

UK Lifescience Industry Magazine

Out of hospital/older people; Medicines Optimisation, Maternity; Children

Children, Young People & Maternal Health; Neuroscience

Urgent & Acute Care

Drug Safety

Robotic Surgery; Healthy Active Living Wound Care; In-silico Science; Neuroscience; Medtech Adoption

Going global

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ISO 13485 UK Lifescience Industry Magazine

ISO 9001 Registered

Quality Management

Registered

Medical Devices 015

Hand held diagnosis for COPD Swansea scientists pioneer search for technology-based solution to diagnose COPD disease

spectroscopy as a rapid, cost-effective and non-invasive technology for COPD diagnosis and prediction of exacerbation.

Welsh-based Glyconics Ltd and Swansea University’s Centre for NanoHealth have set up a partnership to develop a handheld miniaturised device to diagnose and predict the exacerbation of Chronic Obstructive Pulmonary Disease in patients.

With the support of the Swansea team, Glyconics have been awarded an SBRI grant for an initial feasibility study to assess the clinical performance of the miniaturised FTIR device. The Small Business Research Initiative for Healthcare (SBRI Healthcare) is an NHS England initiative, championed by the Academic Health Science Networks (AHSNs), who aim to promote UK economic growth whilst addressing unmet health needs and enhancing the take up of known best practice.

However, current FTIR equipment is prohibitively expensive, restricting any widespread and cost-effective uptake of the methodology. The recent availability of miniaturised components for low cost instruments now offers the opportunity to transform clinical accessibility.

Dr Paul Lewis with handheld device

Chronic Obstructive Pulmonary Disease, or COPD, is a common, progressively disabling disease and a major health burden worldwide. It is not a single disease, but an umbrella term used to describe a spectrum of chronic lung diseases that cause limitations in lung airflow, and includes chronic bronchitis and emphysema.

Within the next seven years, COPD is predicted to be the third leading cause of death worldwide and the fifth most common cause of disability in the world.

The technology, which has been developed

by Dr Paul Lewis of Swansea University’s Centre for NanoHealth (CNH), will be commercialised by Glyconics with Dr Lewis who will be responsible for co-ordinating all technology evaluation, development and clinical programmes.

Dr Berwyn Clarke, CEO of Glyconics Ltd, said: “In the UK, COPD is estimated to affect some six million people causing 24 million working days to be lost, at a cost of nearly £4 billion per year from reduced productivity and is responsible for more than 25,000 deaths annually.

8

“As the disease progresses patients develop increasingly frequent and severe exacerbations and have an increased rate of hospitalisation. This hand-held technology not only allows more accurate diagnosis of COPD at the point-of-care

UK Lifescience Industry Magazine

Dr Lewis’ team are a leading laboratory in the study of infrared spectroscopy for analysis of mucin structure and glycosylation relevant to respiratory disease. They lead the Medlung UK multicentre trial for respiratory diagnostics and have identified patterns in the sputum of patients which are unique to COPD and which have been filed for patents. Further research into other specific respiratory disease patterns are already underway and show promising potential.

The contract from SBRI will enable the implementation of a feasibility study to explore the potential to provide a technology-based solution that can be simply introduced as a means to identify disease severity, disease progression and an early indication of exacerbation.

SEM image taken at the Centre for NanoHealth of Sputum sample

but is also able to detect the onset of exacerbations very early. This is extremely important to the NHS since exacerbations are a major factor in the £1 billion per annum cost of managing COPD.” COPD is currently an under-diagnosed condition, with some 50% of sufferers unaware of their diagnosis. Poor recognition and treatment of respiratory failure increases the risk of mortality; there is thus a currently un-met need to improve diagnostic rates, reduce the burden of exacerbations and prevent the need for hospital admissions.

However, there is currently no existing goldstandard or state-of-the-art technology available to identify early markers of disease exacerbation in COPD. Dr Lewis has identified the potential of using Fourier transform infrared (FTIR)

“

Dr Lewis states “Utilising infrared COPD biomarkers and modern electronic and optical components, the ultimate goal is to develop a hand-held, miniaturised FTIR device for easy detection and monitoring by healthcare workers at the point-of-care. This Phase 1 study will hopefully prepare the ground for a full Phase 2 project, through evaluation of the technical, clinical, regulatory, and commercial viability of the technology, and the preparation of a full implementation and commercial strategy.”

7

UK Lifescience Industry Magazine

Strength & Opportunities The landscape of the medical technology, medical biotechnology, industrial biotechnology and pharmaceutical sectors in the UK

Medical Technology Sector

Medical Biotechnology Sector

The largest segments in terms of employment and turnover are single use technology, in-vitro diagnostics, orthopedic devices, wound care and professional services.

Economic activity is concentrated in the South and East of England with other significant concentrations in Scotland, Wales and the North West of England.

3309

companies

1073

17.6bn turnover

76,700 employees

companies

4.2bn

26,900

turnover

employees

........................................................................... of the total companies are active in R&D

...........................

6-8%

1-5%

annual employment growth between 2009-2013

annual turnover growth between 2009-2013

Employment grew from 2010 onwards with a CAGR of 4.6%.

All the largest segments grew turnover and employment except for professional services.

...........................................................................

The five fastest growing segments based on turnover were: Cardiovascular devices ICT & E-health Infection control Mobility access Anaesthetic technology

The majority

Over the period 2009-2013 the medical o f co m p a n i e s biotechnology sector achieved < 1 0 ye a r s a 22% positive trend in turnover growth with strong performance in the small molecule segment. Over the same period there was a trend of decreasing employment of 3.1%.

48%

The largest segments are drug discovery and development companies involved in antibody and small molecule technologies.

The specialist supplier segment that provides products and services to both the pharmaceutical and medical biotechnology sectors consists of:

of the sector companies

99% staff and 85% with turnovers less than ÂŁ5m are SMEs with

employing less than 250

Economic activity for the sector is more widely dispersed across the UK compared to other life science sectors but with significant concentrations of companies in the East and West Midlands of England and the Southeast and East of England.

903

companies

ÂŁ4.2bn

combined turnover

23,350 employees

The top 50 specialist suppliers include a high proportion of contract research and manufacturing companies and account for 76% of all specialist supplier employment.

4,980

176K

52bn

Event Calendar

In 2013 a total of 4,980 companies employed around 167,000 people and generated a turnover of over ÂŁ52bn.

Industrial Biotechnology Sector

The Pharmaceutical Sector

The biofuels segment along with specialist services and companies providing products into the food & drink sector are the largest in terms of turnover and employment.

The sector is supported by a network of 189 specialist supply companies providing clinical trials, manufacturing, equipment, and regulatory services. This segment employs 6,200 people.

121

companies

477

605m turnover

1,790

employees

The specialist services segment is composed of a range of suppliers of reagents, equipment, engineering services and specialist advice.

The largest companies in this segment are those that supply enzymes and enzyme technology.

.............................................

..........................................

70,310

turnover

employees

...........................................................................

Employment has shown a

5%

CAGR growth over the last

20

The top global pharmaceutical companies account for

Over the period 2011-2013 a subset of

226

5 years

companies

who together account for over

emerging sector SMEs <250

62%

sector employment All of them have activity in the UK.

..........................................

Excluding the Top 20, there are:

53%

turnover increase The group of companies in the sector that represent >75% of all turnover and employment has shown positive increases in both measures. The strongest growth was in the biofuels and specialist services segments.

reduced employment by 2.7%.

This was driven by a large reduction in employment in the global Top 20 companies.

182

companies

16,400 employees

involved in the discovery, development and production of pharmaceuticals

. ...................................................

The distribution of industrial biotechnology activity across the UK shows limited evidence of concentration The sector exhibits the profile of an probably demonstrating the emerging with most companies classified as nature of the with sector. employees.

2009 to 2013

29bn

companies

The sector has a higher proportion of large companies than the national average with

15%

of companies employing

250 or more

Data obtained from the UK Governmentâ&#x20AC;&#x2122;s Department for Business, Innovation and Skills report entitled 'Strength and Opportunity Annual Update 2013'

INNOVATION IS Unlock Your Global Business Potential The life science industry faces increasing challenges, from the rising costs and increasing complexity of research and development to marketplaces that are evolving in response to ageing populations, the prevalence of chronic diseases, and escalating healthcare costs.

guides industry in identifying research, development and delivery partners and provides support through every step of investing in and working in the UK. Industry leaders from the private sector in the LSIO team bring with them a wealth of knowledge, networks and kudos.

That, combined with UKTI’s government insight and navigation skills, is a powerful combination for attracting and securing potential investors.

Dr Mark Treherne is CEO of the LSIO and has been a leading light in the biopharmaceutical industry for 25 years.

He was a co-founder and Chief Executive of Cambridge Drug Discovery Limited and

how it could be implemented. We also found recommended locations and drew up tailored propositions to support them.”

Mark added: “People want to come to the UK and tap into our unique resources, and the LSIO is definitely helping to make that a smoother journey.”

The specialist services offered by the LSIO have recently been extended to incorporate trade opportunities alongside that of investment. This will bring even stronger synergy with support for companies to launch into other international markets once based in the UK.

led the neurodegeneration research group at Pfizer’s research facility.

“We have a 50-50 mix of public and private sector people in the LSIO, and this mix provides the sector credibility together with the civil service skills we need to make things happen,” he said.

Supporting the Government’s Industrial Strategy to help meet these challenges and to signal the importance of the life science sector to the UK economy, UKTI’s Life Science Investment Organisation (LSIO) brings together the public and private sector to create a specialist team for landing inward investment in UK life sciences. The LSIO, established in 2012 to catalyse and co-ordinate life science UK Lifescience Industry Magazine investment across the whole of the UK,

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One of its first successes has been in digital autopsies, developed by Malaysian life sciences company iGene. The UK’s first digital autopsy centre will open this year in Sheffield, with a network of 18 centres across the UK planned within the next couple of years.

Mark said: “We achieved this thanks to a virtual team that included the Commercial Officer in Malaysia and a project team in the UK. The LSIO came into its own as we needed to understand the current clinical practice and talk to leading pathologists to introduce the technology and understand

The UK is a proven route to the European and North American markets, and is expanding reach into the emerging markets. UK companies can also benefit from access to foreign capital and equity investment. Trade wins for UK SMEs can directly impact UK growth potential and value and job creation.

By bringing trade together with investment under the LSIO remit more impact will be made and direct connectivity will be offered for businesses in specific subject matters and to experts across the life science and healthcare sector in the UK. In the UK, partners work together to support a research and innovation culture that spans sectors and geographies, and supports the creation of a fully integrated life science and healthcare ecosystem that places the patient at the heart of the system.

This is all part of the LSIO core focus and is supported by a series of thematic propositions that have been developed with industry consultation to showcase the comparative strengths of UK life sciences. The thematic propositions position the UK on a global perspective and highlight the areas of opportunities and the rich and diverse ecosystem of UK life sciences in the following key areas: Stratified Medicine (launched January 2013): Globally, there is a growing demand for stratified medicines and companion diagnostics. With first class research and expertise, world leading data & translational infrastructure and an established value chain, the UK has a great deal to offer in this space. Today 7% of industry R&D budget is spent on the integration of genomics research into R&D. By 2020 it is estimated that 20% of industry R&D budget will be spent on genomics research to discover and develop new tailored drugs.

Dementia (launched March 2013): An estimated 35 million people globally are living with dementia and this figure is set to double by 2030. The UK recognises the importance of this issue and in 2012 the Prime Minister launched the Dementia Challenge. With world-class research on disease mechanisms and early diagnosis, as well as specialist clinical networks to support translation and access to patients, the UK offer is compelling.

Medical Technologies (launched November 2013): The UK has a rich heritage of medical technology development and despite a difficult economic climate, the sector has grown rapidly over the past 4 years. The UK medical devices market is rising by 7.3% per year and is estimated to reach £9.1 billion by 2018. There are now 3,129 UK based medtech companies employing over 71,000 individuals. With a thriving ecosystem of researchers, scientists, engineers, designers and NHS clinicians, coupled with a proven route to market for innovative technologies, the UK offer in this space is competitive.

Regenerative Medicine and Stem Cells (launched December 2013): Regenerative medicine is one of the most exciting and promising areas of life sciences and UK scientists have been involved since the outset. Europe

has the second largest regenerative medicine ecosystem in the world with 400+ companies related to regenerative medicine. Nearly one in three of SMEs active in Europe’s Advanced Therapy Medicinal Product (ATMP) market are based in the UK. Experimental Medicine and Clinical Trials (launched January 2014): The UK offers a fast, cost-effective and high quality location for experimental medicine and clinical research. This is supported by translational research expertise, unrivalled access to data and leading research facilities. Clinical Research Networks are embedded in the NHS supporting the delivery of multicenter clinical studies. 630,000 patients were recruited in 2013 into clinical research studies. This has trebled since 2010.

Digital Health and Care (launched March 2014): The global digital health and care market is expanding rapidly and the UK will continue to dominate the EU telehealth market with the largest market revenue in Europe. The UK is a worldleader in open data and the global market for Big Data is expected to soar to £30 billion by 2015. Research partnerships are growing across the UK.

The UK’s excellent reputation in research, clinical development, health regulation, and health economics combined with UKTI’s own global connectivity mean that the UK can help businesses maximise their trade and investment potential.

To receive copies of the thematic propositions for UK life sciences contact the UKTI LSIO team at: E: enquiries@ukti-invest.com W:www.ukti.gov.uk/lifesciences @UKTI_LSIO

The latest proposition being developed will highlight the strengths of the UK in Medicines Manufacturing and this will launch by May this year.

The LSIO recognises the need to support every component of the pathway. From bench to bedside, they are making it easier to discover, develop and deliver healthcare innovation in the UK. Business benefit from the support and investment they provide and the opportunity to use the UK as a launch pad to other international markets, whether in Europe or beyond.

ukti.gov.uk/greatbritain

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Medilink UK Awards nominees Every year the eyes of the UK’s Life Sciences sector focus on the Medilink UK Healthcare Business Awards.

This year the awards will take place at the Med-Tech Innovation Expo at the end of Wednesday 2nd April in the centre of the Exhibition.

The shortlisted companies are

Partnership with the NHS Spirit Healthcare About: Spirit Healthcare works with the NHS to improve the lives of patients in the UK. Having started four years ago it now delivers diabetes, dermatology and telehealth products and services to NHS partner organisations.

Why Shortlisted: Spirit Healthcare has developed a telehealth system which flags early warning clinical criteria in the area of COPD – saving the NHS £1,000s through prompt interventions.

drawn from the regional winners

www.spirit-healthcare.co.uk

of the Medilink Awards from

Medilink Region: East Midlands

across the United Kingdom in five categories.

“

Gary Stapleton, Medilink UK’s new Chairman and Business Director of 3M Health Care Business Group, West Europe, said: “This year’s Medilink UK Healthcare Business Awards, which partners with Med-Tech Innovation Expo, is the perfect platform to celebrate those at the very forefront of our sector.

“We’re looking forward to celebrating the outstanding achievements of the national award winners on April 2.”

Vernacare About: Vernacare is a global market leader in single-use medical pulp products, including bedpans and wash bowls for hygienic patient care. The pulp is used in conjunction with the Vernacare manufactured pulp disposal unit to improve infection control and environmental performance in hospitals across 50 countries, including 95% of NHS Trusts.

Why Shortlisted: VernaFem reduces the infection risk of reusable plastic bottles or catheterisation whilst promoting self-toileting to free up nurses’, bringing significant energy and waste savings. www.vernacare.com Medilink Region: North West

Zilico About: Zilico specialises in the design and manufacture of real-time medical diagnostics to address specific clinical needs. Zilico was set up in 2006 on the back of six years research and development within the NHS and University of Sheffield in its first product.

Why Shortlisted: ZedScan™, Zilico’s flagship product, has been developed in collaboration with gynaecologists to improve the ability to detect Cervical Intraepithelial Neoplasia (CIN) in women. ZedScan has many benefits including reducing the number of diagnostic biopsies, facilitating better implementation of “See & Treat” and reducing follow-up appointments. www.zilico.co.uk Medilink Region: Yorkshire & Humber

Innovation Cellnovo About: Cellnovo is a Mobile Diabetes Management System comprised of the world’s smallest insulin patch pump, the first mobile touch-screen handset with built-in glucose meter and Cellnovo Online web-based clinical management tool.

Why Shortlisted: The innovative Cellnovo system allows the information required to manage type 1 diabetes to be stored in a handheld device that acts also a blood glucose meter and sent automatically to a secure website to be accessed by patients and healthcare professionals. www.cellnovo.com Medilink Region: MediWales

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Medilink UK Awards

Medtrade About: Medtrade develops and manufactures unique and innovative wound care and consumer health products for brands owners, providing fast market access with cutting edge technology.

Why Shortlisted: Medtrade’s Celox Rapid Gauze is a new haemostatic bandage used in traumatic injuries that stops the most severe bleeding after a total treatment time of just 90 seconds.

Export Chromogenex Technologies About: Chromogenex Technologies is the UK’s leading developer and manufacturer of advanced light and laser technology systems for use in medical and cosmetic procedures.

www.medtrade.co.uk

Why Shortlisted: With a significant increase in export sales Chromogenex has seen major growth from two of the company’s target markets, Brazil and China.

Medilink Region: North West

www.chromogenex.com Medilink Region: MediWales

TexRAD About: TexRAD Ltd develops and markets novel medical imaging software. TexRAD assists the clinician in managing important diseases such as cancer by quantifying ‘heterogeneity’ from routine diagnostic radiological images and provide an Imaging Biomarker.

Why Shortlisted: Modelling studies have demonstrated that the use of TexRAD to analyse medical images for quantifying tumour heterogeneity can assist clinicians in making decisions such as the suitability for cancer chemotherapy - thus improving the ability to accommodate patient preferences and saving costs of inappropriate treatments. www.texrad.org Medilink Region: South East Health Technologies Alliance (SEHTA)

Quadralene Group About: Quadralene is an independently owned company manufacturing a wide range of high quality, specialised cleaning detergents and disinfectants into the healthcare, dental, food, automotive, and micro-electronic engineering markets.

Why Shortlisted: Quadrelene has seen a substantial increase in its export sales in 2013 from both existing and new market growth from across Europe and Asia. www.quadralene.co.uk/index.html Medilink Region: East Midlands

Sidhil About: Sidhil provides high quality solutions focused on the changing requirements of acute, community, nursing/residential home and GP environments. Sidhil’s range includes electrically operated profiling beds, dynamic and static surfaces, overbed tables, aids for daily living and a selection of specially engineered bariatric products.

Why Shortlisted: Sidhil’s export sales saw a phenomenal increase in 2013 compared with 2012, with a large proportion of those sales coming from new market developments. www.sidhil.com Medilink Region: Yorkshire & Humber

Start-Up Digital Life Sciences Ltd About: Digital Life Sciences Ltd is a whole lifecycle digital business, focused on helping clients within the healthcare sector.

Why Shortlisted: Digital Life Sciences has clearly defined the Digital Health and Care market though rigorous market research. This research has enabled them to successfully penetrate the Digital Health and Care Market and become involved in various new projects. www.digitallifesciences.co.uk Medilink Region: West Midlands

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FLI Medical Innovations About: FLI is a ‘spin-out’ from a well established design, development and manufacturing business. They were initially established to develop ‘FLOTE’, a novel piece of surgical equipment to assist surgeons in a particular approach for Total Hip Replacement, known as the ‘Direct Anterior Approach’.

Outstanding Achievement EKF Diagnostics About: EKF Diagnostics is a worldwide manufacturer of point of care equipment for the measurement of glucose, lactate, haemoglobin, hematocrit and glycated haemoglobin.

www.fliuk.com

Why Shortlisted: EKF had three major influences on their achievement; a new strategy to drive growth in primary markets through its core product range, two significant OEM deals with major distributors that provided access to challenging markets and a new business division, EKF Molecular Diagnostics.

Medilink Region: East Midlands

www.ekfdiagnostics.com

Why Shortlisted: The company has secured significant export orders, supply agreements and surgical trials in a number of markets across the globe (including UK, France, Germany, Australia and USA) in just it’s second year of trading.

Medilink Region: MediWales

TrakCel About: TrakCel is a Clinical Orchestration technology platform designed to efficiently safeguard patients and orchestrate processes across regenerative and cell-based therapies.

Why Shortlisted: TrakCel is a three way joint venture between Biotec Worldwide Supplies Group Limited, AwenID and Scalaris Technologies Ltd. As TrakCel grows and expands it will generate further revenue for each one of the joint venture companies which in turn will create jobs, wealth and clinical expertise for the South Wales region. www.trakcel.com Medilink Region: MediWales

Moor Instruments About: Moor Instruments is a medical device manufacturer, specialising in the development, manufacture and marketing of monitoring and imaging products for blood flow and tissue oxygen measurements.

Why Shortlisted: Moor Instruments has been advancing laser Doppler imaging technology from a purely research tool to a dedicated medical device for burn assessments in clinical settings. In the last two years, the device has generated revenue and increased Moor’s turnover significantly.

To date, the company has supplied Burn Assessment systems to hospitals in over 20 countries worldwide. www.moor.co.uk Medilink Region: South West

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Preventx About: Preventx Limited is an integrated diagnostics company that specialises in making patient diagnosis in the field of sexual health easier, accessible and cost effective. Preventx works with the NHS to provide Chlamydia testing to young people in over 150 local authorities via www. freetest.me, with circa 80,000 tests being completed per annum.

Why Shortlisted: From 2008-2010 Preventx were processing around 30,000 laboratory tests per annum.

These tests were being subcontracted which represented one of the largest company outgoings. In 2011 Preventx opened an in-house microbiology to reduce these costs. The Preventx Laboratory has allowed Preventx to drastically reduce the cost of testing by 70%, whilst improving control over sample turnaround times. www.preventx.com Medilink Region: Yorkshire & Humber

Knowledge Transfer Network HealthTech and Medicines

Building a Healthy Nation through Business Innovation

FINANCE FOR INNOVATION

The Health KTN (www.healthktn.org), now represented by KTN Ltd, maintains an in-depth oversight of the public funding schemes of relevance to UK businesses. Many schemes are exclusive to small organisations but a good number are relevant to large organisations as well, and they can span a product development pipeline from very early stage idea and market development (Smart) to late stage clinical trials (BioMedical Catalyst). Funders include Research Councils to develop people, technologies and novel approaches; Technology Strategy Board and Devolved Administrations to support businesses and generate wealth creation; Department of Health/National Institute for Health Research to support programmes that improve health and social care outcomes and then the European Commission to support innovation at European level (i.e. Horizon 2020). The accompanying diagram gives a simplified view of the range of supporting mechanisms. If you are innovating in the UK, there will often be something relevant to you, so explore the opportunities by contacting narpal.sihra@health-ktn.org.

Excellence in Science

Europe

www.FP7uk.co.uk

Business Angels

Leadership in KEITs

H2020

Societal Challenges

Innovation Platforms

TSB

BioMedical CatalystR&D

Collaborative R&D

National

KTP

Catapults

www.FP7uk.co.uk

SBRI

Venture Capitalists

TSBSmart Smart: Scotland

Devolved Administrations/ Regional Funding

Manufacturing Advisory Service (MAS)

R&D Grant: Scotland

Regional Growth Funds

i4i

DOH/NIHR

www.nihr-ccf.org.uk

Research Councils

www.rcuk.ac.uk

Private Investors

HTCs

HICF

Responsive Mode Research

Industrial CASE AWARDS

Managed Programmes

Case Awards

KTA

IKCs

TECHNOLOGY READINESS LEVEL (TRL)

1

2 Basic Research

3

4

5 Applied Research

6

7

8 Commercialisation

9

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Technology Strategy UK Lifescience IndustryBoard Magazine Driving Innovation

Obsolescence Management A proactive approach to managing risk and minimising disruption to production.

The life span of many modern consumer electronic devices, such as a mobile phone or tablet is relatively short. This can be from a matter of months to a few years. The need to change and an inherent ability to fall out of fashion is driving the development of new components within consumer electronics.

This rapid rate of change has generated a particular problem of obsolescence management in industries where long-term manufacturing of a product may be required for periods of 5, 10 or even 20 years.

Medical device manufacture is one such industry where obsolescence management is a vital role played by the electronics manufacturer.

The drive for smaller, faster and more flexible devices with more functionality is one thing, however, set this against a background of decreasing healthcare budgets and the result is a system which will utilise equipment which still performs adequately, with an added premium on the maintenance programmes which are vital to ensure continued reliable service. The present system encourages medical OEMs to focus on a long term manufacturing strategy rather that continuous upgrades or revisions.

The key observation that “many medical devices have longer lifecycles than the components used to make them” highlights just how critical managing obsolescence is.

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What is Component Obsolescence in the Medtech Industry?

Obsolescence in the medical industry generally occurs as a result of the “slowly evolving” Medtech industry relying upon a supply chain that has been developed to support a rapidly changing industry like consumer electronics. This problem is further exacerbated by considerably lower production volumes over longer timescales compared to consumer electronic for example where OEMs expect a quick turnaround in significant volumes.

There are a number of factors which drive obsolescence: Market Change – All markets change, demand alters for many different reasons.

With electronics generally piggybacking on the consumer products, markets are dynamic thus changing the demand for components. In a slow burn market like medtech this change in demand for components or in some cases the cessation of production of components because of a lack of demand is common.

Technological Evolution – A new and mostly further developed generation of technology will inevitably replace older technologies impacting on availability.

Technologies with a high rate of innovation will inevitably suffer higher rates of component obsolescence.

Technological Revolution – In an increasing number of cases old technology is being completely replaced by new. Consider the implication of this on a medical company who after a design phase build prototypes, secure CE marking and then enter a period of clinical trials. This can last beyond 18 months and it is well known that advances in technology do not stand still.

Obsolescence and Medical Devices Most consumer electronics have lifecycles of 18 months, whereas many medical devices have a product life in excess of 10 years. This simple statement of comparison between consumer electronics and medical devices illustrates the complexities of obsolescence management in this area.

It is important to consider just what this statement means and why obsolescence management is such a vital component provided to any OEM. Medical devices are typically not subject to technology upgrades.

High costs and long development times associated with the product development cycle make this prohibitive. In medical device manufacture it is common to encounter some considerable obstacles to modification and systems upgrades in order to maintain a device.

The first obstacle to consider is based around the number of medical devices which contain “safety critical” components. The critical components are subject to a lengthy and costly qualification and verification process even for minor changes before the manufacturing phase can begin.

One of the key roles for any Electronics Manufacturing Solutions (EMS) provider is sourcing components for their customers. As discussed the components are rapidly undergoing technology advancements both in performance and size. These rapid changes present a challenge to every EMS provider in keeping

Obsolescence Management their customers up to date with changes especially when dealing with components which are approaching obsolescence. This is especially relevant when working with OEMs who manufacture medical devices.

Jackie Beresford, Operation’s Manager at Elite Electronics Systems in Enniskillen, Northern Ireland outlines the processes Elite have implemented to keep their customers ahead of the game.

The process of obsolescence management begins at the quoting stage. An experienced quoting team with an excellent understanding of component management will work closely with key suppliers to identify components which may face obsolescence in the short to medium term, or which may be hard to source as production approaches. At that early stage in the process, Elite will pass this information to potential customers and in some instances make recommendations on alternative components.

Jackie explains “as manufacturers we understand the process and financial implications of components going obsolete, during production.

The excellent relationships we maintain with suppliers enable us to identify component sourcing and obsolescence at a very early stage and present that information as part of the quote.”

Raising the issue of obsolescence early in the process has major benefits for the OEMs whether they choose to work with Elite or not.

Obsolescence is a more pressing issue with Elite’s existing customers, most of whom have been manufacturing with Elite for a considerable period of time.

Component obsolescence for many of these longstanding customers is inevitable and Elite work very closely with suppliers and customers to manage obsolescence and reduce any risk associated with it.

www.elitees.com

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ENHANCEMENT Innovative solutions for pathology modernisation Collecting hard data from histopathologists (doctors who specialise in studying the changes caused by disease in human tissues) is a problem that is increasing with the amount of information required to manage patients who have been diagnosed with cancer.

Histopathology historically has been a descriptive discipline and consultants are currently trained to examine specimens and then to write a descriptive text report. This is because the clinicians treating these patients increasingly need a range of information in a fairly standard format in order to select the most appropriate treatment for an individual. The collation of this data is considered crucial in order to facilitate analysis of outcomes for multiple patients with the same diagnosis.

Obtaining such information from a histopathology report is difficult because there is little, if any, standardisation in reports produced by the same pathologist and even less between several consultants.

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Derbyshire headquartered AES Medical have developed ‘PathoSys’ with the help of consultants pathologists and clinicians to remedy this situation. PathoSys is an innovative Clinical Decision Support System which produces a traditional text report whilst collecting all the relevant data items and structuring and storing them in a relational database. This ensures that all the important features of a histopathology report are included in a descriptive report and also allows for the distribution and analysis of high quality data items. No data mining is required; the histopathology “black hole” is filled.

PathoSys has the highest level of accreditation offered by the Royal College of Pathologists and helps to achieve compliance with the Pathology Cancer Standards including Cancer Standard 3D-105. The system enables uniform and more accurate diagnosis and reporting of cancer specimens, including standardisation of cancer reports, pathological staging data and

associated coding (SNOMED). Moreover, it contributes to achieving the cancer awaiting time target from referral to treatment by allowing monitoring and audits of turnaround times.

Haematologists work as a team to treat patients with blood diseases and in a similar vein ‘HaemoSys’ has been developed to help them to do this both efficiently and effectively. This system allows the whole of the team to work with the same real time information, ensures that the correct diagnostic tests have been undertaken and tracks their progress. It also allows for the collection of clinical notes and the progress of a patient is recorded throughout their treatment and this means that the individual can be analysed at every stage of their illness. Like PathoSys, the HaemoSys system collects data to allow for clinical audit and research.

PathoSys and Haemosys are proving today to be the essential pre-requisites of several pathology modernisation programmes.

www.aesgrp.com/medical

Enhancement

Detectors fit for epilepsy Medpage Limited trading as Easylink UK, specialises in the design and manufacture of Epileptic Seizure movement detectors.

The original model the Medpage MP5 was first introduced to market in 1996 and since then has been a market leader in the UK. Using analogue circuitry to amplify the signals detected from a sensor positioned under a patient’s mattress, the scope of seizure detection was limited- prohibiting detection of more complex seizure types, especially from younger patients and patients with lower body mass. To increase its suitability and reliability to a wider patient range, a new sensor technology with a means of accurately

interpreting a patient’s movement during sleep had to be developed.

Initial research identified that the use of piezo electric materials could be used not only to detect seizure typical movement, but that they could also detect breathing movements from the patient’s bed. This technology was patented by the company in 2006 and the first model it produced had improved sensitivity and did dramatically improve seizure rate detection for patients experiencing Tonic or Clonic seizures. However, from data supplied by epilepsy professionals, further improvement was required if the more complex seizures were to be reliably detected.

Extensive research was then conducted using various grades of plastics to ascertain the best medium for detecting resonant frequencies produced by seizure movement from a person’s bed. Neil Dines, the company’s product development manager, embarked on the development of sophisticated software algorithms to accurately interpret and identify seizure movement from normal sleeping movements, such as breathing, turning over etc. With the aid of funding from Medilink, the company is now set to launch a seizure movement monitor with new sensor technology that has already proved successful in all trials.

www.easylinkuk.com

Award winning partnership provides unique software solution Software and web development company Switchstance has developed a unique solution to help integrate innovative diagnostic medical products with the UK’s main clinical IT systems.

In order to achieve this, Switchstance collaborated with diagnostic medical product supplier Numed Healthcare.

Numed currently supplies products which integrate with the three leading clinical systems providers, including EMIS and TPP, which cover over 10,500 GP practices across the UK. Switchstance worked with Numed to redesign and streamline how its products integrate with the key clinical systems, providing a future-proof, global platform within primary care. This created an overall process improvement as the products from Numed such as blood pressure, ECG and Spirometry devices were integrated into the system.

Prior to the collaboration, Numed had separate software solutions for each of their products to integrate with each clinical system, which proved time consuming to maintain individually.

The bespoke system developed with Switchstance provides significant time saving as its centralised application means that individual software applications do not have to be opened for each product. In addition, Switchstance addressed the increasing trend of GP practices moving to the Windows 7 operating system and a smooth transition was required to accommodate this.

Craig Hirst, General Manager at Numed Healthcare, said: “Switchstance was an ideal partner for Numed as the team has previous experience working in the healthcare sector, particularly in the management, interrogation and transfer of patient-level data.

“After providing Switchstance with an initial specification and scoping document, they quickly produced a timed project plan. We regularly exchanged information and received progress updates without having to chase them.

“During the acceptance testing phase, bugs and amendments were addressed and an update made available to us very

rapidly. The final software was a product we are proud of and one which we are now continuing to expand and develop further with the Switchstance team.”

Switchstance also won the 2012 Medilink Yorkshire & Humber ‘Partnership with the NHS’ Award.

“

“Our expertise in web technologies and information governance, specifically within the NHS, proved really valuable on this project and we were delighted to be able to develop this solution in partnership with Numed.”

Matt Cuff, Managing Director of Switchstance

www.switchstanceit.com

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Dual solution for pain relief Snowden Healthcare Ltd has been manufacturing pain relief products for over 20 years. Three years ago it managed to maintain its market position during challenging economic times but knew that if it was to flourish then new product development would play an important role.

However the development and marketing of a new device was seen as a significant step for a relatively small company and it needed to access support and expert advice in order to reduce the risk to the company and maximise the potential for speedy and sustained growth.

The company’s existing product lines were mainly a mix of pain relief devices and consumables such as Medicur, Glucosamine Gold Gels and Glucosamine Joint Patches marketed directly to their mainly UK customer base via mail order.

Snowden identified a need to expand its pain relief device range that would complement the existing product range and provide a route to expansion of its existing customer base as well as a route to new markets.

Brendan McElroy, brand and marketing director at Snowden Healthcare, approached the Healthcare and Bioscience iNet to find out what help was available. An iNet business adviser discussed the options and provided advice on market research as well as assistance to apply for part-funding

During a research phase the company considered a number of technologies before deciding that ultrasound was the solution they would progress.

The company held a strong insight into its customers’ needs and was confident that an ultrasound device would be simple to use and easily accepted by those who often are in pain and have poor joint mobility.

Furthermore, the fact that ultrasound therapy was already commonly used by physiotherapists for pain relief and by other medical practitioners for obstetric and other uses would lead to good public acceptance.

Snowden Healthcare’s existing product lines, particularly the glucosamine, arnica and opti-5 gels, were all effective when used to relieve joint pain but the latest health research was showing that the effectiveness of pain relief gels could be markedly improved if they were used in combination with ultrasound therapy. The existing product lines meant that Snowden Healthcare was well placed to provide a combined solution of ultrasound device and pain relief gel if it could act quickly to develop a device before its competitors.

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of the prototyping, development and marketing costs from the iNet IAG grant fund.

The grant application was successful and over the course of the product development cycle Brendan had a number of meetings with the iNet adviser and attended iNet events such as their annual Innovation Day to obtain further advice and to meet other useful contacts. The company also talked to the University of Nottingham, the National Pain Centre and Arthritis Research UK to ensure that the product would meet patient needs as closely as possible.

“

Brendan McElroy said: “The support of the iNet reduced the risk and enabled us to introduce a product that has benefited our customers and helped transform our company’s prospects. What’s more that gave us the confidence to develop the next product and we are now looking at export markets so our future looks bright. The iNet team was so easy to deal with – the process was simple, quick, honest and straight forward throughout.”

Testimony The product, ‘Arthrosound’ has now been on the market for 14 months and has already achieved impressive sales. Furthermore as a direct result of introducing this new product Snowdon Healthcare has taken on 3 new staff to reach a total workforce of 14 and has gone on to develop Arthrosound Pro, a cordless version of the device.

Enhancement

Reflux gets a pep-up

Doctors and healthcare professionals who have been using the world’s first non-invasive test to diagnose reflux are urging others to do the same.

‘Peptest’ is a unique testing kit developed by UK-based RD Biomed.

The kit can be ordered directly by both doctors and patients, which is one reason it is so efficient. The patient simply has to provide saliva samples at the time of the symptoms and then sends these back to RD Biomed where they are then tested. The patient receives the results within two days either by post or electronically.

The kit works by measuring a patient’s saliva for levels of pepsin, an enzyme found in the stomach. If a patient’s Peptest is consistently positive of pepsin, then it is likely that they are suffering from reflux, and it can also be an indicator of other reflux-associated conditions.

The test has received backing from clinicians across the UK. Dr Gabriel Hendow, a GP and an ENT specialist, uses Peptest regularly in his clinic at Bransholme Health Centre in Hull.

Dr Hendow said: “I would definitely recommend Peptest to other GPs as it is an excellent diagnostic tool. It is also

a fraction of the price I would incur, should I refer my patient to secondary care.

“I can give my patient a Peptest kit for them to do in their own time; it’s extremely simple and pain-free. It is important that we test and diagnose patients as soon as possible in order to alleviate the symptoms of reflux and give the patient appropriate treatment.

Peptest is the quickest and most accurate way to do this.”

Without early diagnosis and treatment reflux can in time lead to severe damage to the oesophagus (erosive oesophagitis) and to a pre-cancerous condition called Barrett’s Oesophagus which in some cases can lead to oesophageal cancer. In certain cases it may also be linked to cancer of the larynx.

Current reflux detection methods are time-consuming and extremely unpleasant for the patient. Tests such as dual channel 24-hour PH monitoring or multi-channel intraluminal impedance measurement both require the patient having a catheter inserted down their nose, into the stomach and taped in place for 24-hours.

“

Mr Mark Watson, a consultant ENT surgeon at Doncaster Infirmary, said: “With some of my patients I need to confirm that the diagnosis of reflux and particularly laryngopharyngeal reflux, a slightly different strain of the disease commonly known as ‘silent reflux’, is correct before we go on for further treatment.

“Peptest is great for my work because it’s simple, noninvasive, relatively cheap and easy for the patients to perform.”

Peptest saves considerable amounts of time and is completely non-invasive.

It costs £60 to conduct a three sample Peptest analysis whereas it could cost in excess of £750 to conduct an invasive procedure.

It is estimated 10-20% of people in Western countries suffer from reflux related symptoms and prevalence has been reported as high as 34% to 44% from some studies.

www.peptest.co.uk

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FUTURE WATCH Redbook goes digital The Personal Child Health Record (also known as the PCHR or ‘Red Book’) is a national standard health and development record given to parents/carers at a child’s birth.

This is the main record of a child’s health and development; the parent/carer retains the Red Book and health professionals should update the record each time the child is seen in a healthcare setting.

There is no intention to withdraw the paper PCHR as it is important that parents have a choice as to how they access information.

The next generation can expect data-driven healthcare from the cradle to the grave; and their first step is likely to be the eRedbook, a digital version of the paper Redbook, which logs a child’s healthcare information (growth, vaccinations, checkups, episodes etc.) from birth.

Electronic PCHR (ePCHR) The ePCHR is a digital version of the printed Personal Child Health Record or ‘Redbook’.

The Royal College of Paediatrics and Child Health (RCPCH) has a keen interest in how effectively the content of the Personal Child Health Record is made available in digital format. For this reason the College has agreed a set of standards for software development to provide a framework for suppliers providing an electronic version of the record.

“

As a father of a one year old daughter, I am particularly interested in the eRedbook, allowing parents to keep accurate and up to date records of their child’s early development online” Jeremy Hunt, Health Secretary

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UK Lifescience Industry Magazine

The RCPCH is working with Sitekit to evaluate the usability and benefits of a prototype version of an ePCHR. This prototype is called the ‘eRedbook’.

Sitekit have partnered with Harlow Printing Ltd, who print the current PCHR and the initial development has been funded through Microsoft, a Technology Strategy Board project called ‘Year Zero’ and economic development funding from Highlands and Islands Enterprise board (HIE).

Development of the eRedbook is handled through a specially convened Clinical Advisory Group and the intercollegiate Personal Child Health Record Committee. The eRedbook is currently available through NHS Partner sites during evaluation, these sites are Liverpool Community Health, and

NHS South Warwickshire, and is also available through a smartphone App. Those interested in knowing more can find information on the eRedbook at http://eredbook.org.uk/ Dan Moulin, Sitekit Applications Director, says “The eRedbook is very closely tied to the paper version. Clinical assurance is fundamental to NHS organisations adopting it, so it’s crucial that we work only with approved content. We are looking to expand that content with the DH’s ‘Information services for Parents’, which will also be approved.”

“But whilst there isn’t new data, what is new is how parents can use it and what they can achieve with it. The eRedbook gives us many opportunities to use technology to improve the engagement of parents in their child’s health. The paper Redbook can get lost; and sometimes it’s just not convenient to update it. The App, however, is in parents’ pockets – at home and in the GP’s surgery. It makes keeping a child’s record up-to-date and complete both collaborative and frictionless. It’s also proactive: with the eRedbook, we can present important data to the parent and prompt them with upcoming appointments. Parents can log discussions with healthcare providers, and even check test results online”.

Future watch

The eRedbook is also part of the Year Zero programme; an initiative designed to data-enable a patient’s whole lifetime of interactions with healthcare providers; and Year Zero itself is one of several projects under the umbrella of the DALLAS (Delivering Assisted Living Lifestyles At Scale) programme; majority funded by the Technology Strategy Board.

That said, eRedbook has been on Microsoft’s agenda for some time. Says Mark Smith, Microsoft UK Director of Health and Life Sciences, “When HealthVault launched in the UK in late 2010, we were contacted by several Trusts interested in what applications a secure, trusted and reliable healthcare data repository might support. The Redbook was one of the ideas which Trusts regularly mentioned, and we have progressed it ever since.”

Smith continues, “It is, after all, an excellent use case for the Personal Health Record (PHR). Parents are a highly engaged and motivated audience. There is also a high penetration of smartphones among parents. The government has a target of delivering full access to patient data by 2015; but open data is only useful if we do something interesting with that

data; and this is a great example of the co-production of care in action.

“HealthVault also supports collaborative care projects like eRedbook by providing simple yet secure sharing of healthcare data. Parents can share their child’s developmental data with GPs, other healthcare professionals, and indeed other members of the family.”

As one early user of eRedbook says in a video testimonial, “If my mum wants to take him for an appointment [and understand what is being discussed], she can do that”.

As the eRedbook develops, families requiring more care for their children’s conditions (diabetes, for example), can be presented with continuously relevant information and service navigation options. There will be eRedbook modules for particular conditions.

Early feedback from Trusts has been very positive. As well as the Year Zero community of Trusts, the eRedbook has attracted the interest of many other trusts, including NHS Portsmouth and Tower Hamlets.

“

Sitekit’s Dan Moulin says: “There is a massive opportunity here for engaging citizens in healthcare and self-care, if you look at the original purpose of the Redbook, it was partly to engage parents in the health of their children. The eRedbook, on the foundation of HealthVault, is the ideal opportunity to engage whole families with their personal records online and early in life; and also introduce other techenabled health applications.

The next step will be a launch to healthcare professionals later this year – parents will be invited by their health visitors to participate. Later, further integration with other child health information systems is planned, in order to cut out information duplication and deliver ever more seamless care and information pathways.

NHS partners wishing to get involved in the project should contact info@eredbook.org

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UK Lifescience Industry Magazine

Max-Planck heads north The world’s first International MaxPlanck Partnership has been launched by five Scottish universities.

The multi-million pound partnership, with five prestigious Max-Planck Institutes (MPI) in Germany, is a major boost to the future development of new quantum technologies and fundamental science in Scotland.

The initiative will significantly strengthen research links between Scotland and Germany – and enhance Scotland’s reputation as a world leader in fundamental, or ‘discovery’, science which forms the foundations of emerging and future technologies.

The collaboration will lead to the establishment of the world’s first International Max-Planck Partnership (IMPP). This new model will incorporate leading physics research groups from the universities of Glasgow, Strathclyde, St Andrews, Heriot-Watt and Edinburgh with The Max Planck Institute for Gravitational Physics (Albert Einstein Institute) Hannover; the MPI for the Science of Light, Erlangen;

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UK Lifescience Industry Magazine

the MPI for Quantum Optics, Garching; the MPI for Chemical Physics, Dresden; and the MPI for Solid State Physics, Stuttgart.

The Centre will specifically support research around the theme of ‘Measurement and Observation at the Quantum Limit’ (MOQL), which has relevance for a variety of hi-tech industry sectors including oil field exploration and quantum computing.

Strathclyde is home to the Fraunhofer Centre for Applied Photonics. Scotland is already a leading centre for research in quantum technologies and this partnership will complement the country’s existing world-class science and engineering research bases, including the new £10 million Centre for Sensors & Imaging Systems (CENSIS) based at the University of Glasgow, which opens in January 2014, and the Fraunhofer Centre for Applied Photonics at the University of Strathclyde.

By facilitating research collaborations and knowledge exchange between

leading domestic and international institutes, Scotland is now in a position to establish itself as an international hub for the discovery and exploitation of cutting-edge science and technology – and a magnet for the world’s best researchers in the field.

The IMPP Partnership is supported by funding from the Scottish Funding Council, and a joint grant from the Engineering and Physical Sciences Research Council and the Science & Technology Facilities Council. The Scottish universities involved will also contribute to the initial funding package of up to £10 million over five years.

Minister for Science Alasdair Allan, MSP, said: “It is great news that the world’s first international Max-Planck partnership is being launched by Scottish Universities. This is another example of the global reputation and strength of research in Scotland and will help further boost our higher education sector.

“As a Government, through the Scottish Funding Council, we now invest over £1 billion annually in higher education,

Future watch

some of which – in conjunction with our internationally renowned Research Pools - has been allocated to help deliver this important and exciting research initiative.”

Professor Jim Hough, UK Director of the Partnership, said: “The MOQL MaxPlanck Partnership is the first such collaboration of its kind and reflects the strength of the existing research community and infrastructure within Scotland. It will aim to promote new scientific collaborations at the very highest levels and raise the profile of Scottish Science, attracting some of the world’s leading physicists to our institutions.

“

Alice Brown, Chair of SFC, said: “This unique partnership is an exciting opportunity for leading Physicists in Scotland and Germany to collaborate on fundamental research with potential real world applications.

It is also a fantastic opportunity for research students to work on projects of the highest calibre.

Intelligent care solutions Intelligent Sensors & Solutions Limited (‘isensol’) is a UK-based electronics company committed to improving the care of the elderly and disabled and supporting independent and assisted living through the application of its proprietary technologies. The company is developing a range of sensors which are battery-operated and can be self-installed, offering full plug-and-play compatibility with its CloudCare monitoring and alert service. The CloudCare solution is high-performance yet low-cost and scales from domestic homes to multi-occupancy residential care homes. It is the first solution of its type with relevance in both the retail and commercial sectors.

The sensor technologies offered by isensol include an innovative bed occupancy sensor capable of determining occupancy, position, movement, temperature and enuresis; a room occupancy sensor that can discriminate between people and pets and detect changes in mobility over time; a door sensor that can count and differentiate between ingress and egress. All of these technologies are proprietary to isensol and are underpinned by an extensive intellectual property portfolio.

All of the sensors use advanced bi-directional communications protocols and can be monitored remotely via the CloudCare service. The CloudCare service protects privacy and dignity yet provides 24/7/365 monitoring, alert and audit capabilities for carers and peace-of-mind for family members via the Internet or any mobile device.

The CloudCare solution has already attracted the attention of customers and distributors in both the EU and the USA, and isensol expects to launch the solution later this year.

“The partnership’s research aims have the potential to have a big impact on society and the research community in Scotland and across the globe. Building on Max Planck’s own research on discrete energy levels, today’s researchers will be able to improve lasers for commercial, industrial and medical applications, further develop quantum cryptography to prevent cyber-crime and explore the possibility of quantum computing systems that can do complex calculations billions of time faster than those we use today. I am delighted SFC can support this partnership.”

www.mpg.de/en

www.isensol.com

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UK Lifescience Industry Magazine

GOING GLOBAL Sweet answers for wound care Based in Nottinghamshire, wound care specialist Advancis Medical started in 2004 with the aim of bringing advanced woundcare products into the market that were innovative, had a strong patient focus and offered healthcare professionals cost effective solutions. Woundcare in the UK is a competitive market with many established companies therefore Advancis launched itself with a unique range of Manuka honey dressings and other complementing products which are proven to reduce healing time. Advancis was the first company to introduce medical grade Manuka honey as a medical device into the UK and is now recognised as a top 10 woundcare company in Great Britain, where it has gained

a reputation for high quality products which can compete against the best from the market leaders. The company works with clinicians, nurses and carers to provide innovative products which put the needs of the patient first and it has recently added two new unique products to its super absorbent dressings range, Eclypse.

The new Eclypse Border and Eclypse Border Oval are super absorbent dressings with a self-adhesive soft silicone contact layer and hypoallergenic border. The soft silicone layer provides gentle adherence and will facilitate atraumatic removal and the hypo-allergenic border allows further adhesion. These two new dressings have also been added to the Drug Tariff.

The dressing itself has a rapid wicking face and a highly absorbent moisture locking system with an additional wicking layer to further maintain the integrity of the dressing and help to distribute exudate across the entire dressing, meaning that it remains comfortable to the patient, does not become bulky and reduces the risk of any additional damage or pressure to the wound bed.

These three-in-one enhanced dressings absorb up to 50 per cent more fluid

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UK Lifescience Industry Magazine

www.advancis.co.uk

and the unique combination silicone and hypo-allergenic acrylic adhesive border provides simplified dressing selection and reduced costs for healthcare provider.

The Eclypse Border and Border Oval range require no secondary fixation, have higher fluid handling capacity and can be worn for up to seven days.

The new additions to the Eclypse range were launched at the Wounds UK Annual Conference 2013. This event is the largest exhibition of wound care companies in the UK, with over 1,300 visitors attending every year.

“

Mark Allatt, Advancis Medical Sales and Marketing Director, said: “These additions to our Eclypse Range demonstrate our ongoing commitment to developing innovative wound care products which meet the clinical needs of the patient.

“The Eclypse Border dressings promote wound healing by being highly absorbent, reducing the risk of infection and therefore providing the optimum wound environment for healing to occur.”

Advancis is now looking to move the company from a UK based sales company, with 95% of sales in its home market, to a truly global one. Ethical distributors started this process by opening up opportunities in Europe and this then expanded into the Middle East, SE Asia and Australasia. Advancis satellite companies have now been opened in key markets allowing the company to build even stronger roots and work closely with its customers.

So far operations in Germany, Holland, France and the US have been created and all are seeing healthy sales growth.

Going global

British companies look to growing African healthcare market A delegation of healthcare companies from across the UK will travel to South Africa in May to present their products and services to an international audience at the Africa Health exhibition.

Africa Health is the largest healthcare exhibition in the region and attracts distributors and decision makers from across SubSaharan Africa. The exhibition will take place in Johannesburg, South Africa from 29-31 May. Companies on the UK pavilion will join over 400 international exhibitors and more than 5,000 attendees over the three days.

Some of the exhibiting UK companies include: Natural Wellbeing, supplier and manufacturer of vitamins and dietary food supplements;; Logichem, leading supplier of medical and pharmaceutical products; and Priorclave, manufacturers of autoclaves used to sterilise equipment.

The rapid growth of the African healthcare sector in recent years has resulted in greater opportunities for healthcare companies - with Africa Health providing the ideal platform for the UK healthcare industry to showcase its latest innovations, techniques and solutions to key decision makers, clinicians, distributors and end-users.

The UK pavilion is being heavily supported by UK Trade & Investment (UKTI) – the Government department which works with businesses based in the UK to ensure their success in international markets, and Medilink UK.

“

Peter Wheeler, who will represent UKTI and Medilink UK at the exhibition, said: “Sub-Saharan Africa accounts for 11 per cent of the world’s population and it is estimated that its healthcare market will reach $35 billion by 2016.

“With the region importing the majority of its medical devices, there has never been a better time for UK companies to enter the market and take advantage of this growth.”

Africa Health takes place from 29 – 31 May at Gallagher Convention Centre, Midrand, Johannesburg, South Africa.

www.africahealthexhibition.com

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Interested in overseas exhibitions? www.abhi.org.uk/export/exhibitions

Association of British Healthcare Industries

Advancing Access to Medical Technology

About ABHI: ABHI’s mission is to champion the benefits and use of safe and effective medical technologies to deliver high quality patient outcomes.

With over 240 members, ABHI leads the advocacy of the industry in order to advance access to medical technology. Our membership includes some of the leading multinational businesses in the sector in the UK right the way through to small and medium sized enterprises (SMEs).

Over the next 12 months ABHI will deliver a comprehensive event schedule comprised of networking events, seminars and conferences.

The event conference calendar will include the UK Market Conference, one of ABHI’s premier events, which will once again aim to provide insight into the changing environment in which the medical technology industry works. Other key events in the calendar include the ABHI Seminar on UDI Implementation in US, UK and EU markets and the MDR Conference which will provide delegates with the latest information and critical insight on the revisions to the Medical Device Legislation, providing manufacturers with a head start for adoption and, thus, a competitive advantage. The 2014 calendar will also include a series of export seminars on key international markets, designed to address issues which UK companies face when they look to access and grow business in those markets.

ABHI The New Public Procurement Legislation Seminar 29 April 2014, London In January, the European Parliament accepted changes to the existing public procurement directives. This marks the most significant reform of public procurement law since 2004. To ensure your organisation is ready for the rules, ABHI will host this half-day seminar to highlight the key changes and their impact on industry.

This seminar is supported by CMS Cameron McKenna.

ABHI UDI Seminar: The Here and Now of Implementation 14 May 2014, London Unique Device Identification (UDI) systems are rapidly becoming a reality for medical devices and in vitro diagnostics (IVDs). ABHI is offering a unique insight for UK companies in a one day seminar to be led by Jay Crowley, Vice President of UDI practice at USDM Life Sciences.

ABHI’s event schedule is evolving continuously. For an up to date event schedule and for more information on the events listed please go to: www.abhi.org.uk/events

ABHI has three different types of membership, Corporate Membership, Professional Associate Membership and Industry Association Membership. For more information about membership please contact Angela Jeffery on 020 7960 4360.

To sign up to receive ABHI publications go to: www.abhi.org.uk/register/

Key contacts: Angela Jeffery

Membership Development Manager angela.jeffery@abhi.org.uk

Jane Sessenwein

Manager, Events jane.sessenwein@abhi.org.uk

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Sarah Izon

ABHI Communications Seminar June 2014, London Influencing the Influencers: How to communicate effectively with stakeholders and the media. Learn top tips and methods for communicating effectively for maximum results.

ABHI Export Seminar Series ABHI Export Seminar: A focus on India, June 2014 ABHI Export Seminar: A focus on Russia, October 2014 ABHI Export Seminar: A focus on Brazil, September 2014 ABHI Export Seminar: A focus on the Middle East, November 2014

Exhibitions Executive sarah.izon@abhi.org.uk

UK Lifescience Magazine

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

Going Global

Quadralene takes on the US Derbyshire-based manufacturer Quadralene, is on the verge of a major breakthrough into the US. Despite the recently difficult economic climate, the last five years has seen Quadralene become one of Derby’s biggest success stories, establishing itself as a leading manufacturer of infection control solutions. This award-winning company now exports to 48 countries worldwide and is successfully taking its messages of innovation, education and compliance to international markets throughout the world.

Quadralene’s success has been largely driven by its willingness to diversify, transforming itself from a manufacturer of cleaning detergents and disinfectants for the automotive and engineering markets, into a specialised, research based provider of infection control solutions in the healthcare and dental markets. By utilising in-house R&D competency, Quadralene has successfully exploited the sizeable potential in the compliance driven healthcare market and this sector now accounts for 34 percent of its overall sales.

Quadralene won the 2013 Medilink East Midlands Export Achievement award, in recognition of the 70% growth in export sales achieved during the year. With a forecast to rise by a further 50% in 2014, and with the imminent confirmation of a US contract, this forecast is likely to be exceeded by some way.

“

Managing Director Andy Corley has steered Quadralene on its five-year journey, but is keen to commend the teamwork that is at the heart of their success.

“Where international expansion is concerned, overcoming cultural barriers is obviously a challenge, but it’s about having the confidence in your business’ capabilities, which helps overcome these obstacles. We have been fortunate that our team has embraced our diversification and enabled us to become lean and responsive to the changing needs of our markets.”

Exports Double for Cornish consultancy Cornish based Regulatory Affairs Consultancy, TRAC Services Limited, has seen export sales almost double in the past year.

The consultancy, which helps pharmaceutical companies comply with government legislation for the regulation of medicines, has seen export sales grow from 13% to 22% year on year and significantly increase its presence in the USA market.

TRAC reported an overall growth in sales of 45% in the last financial year and was ranked in the top 100 companies of the UK Healthcare Consultants market in an independent research report published by Plimsoll.

The report also rated TRAC as the 23rd fastest growing company in a sector

“

“The regulatory environment in the USA is very different to Europe. Over the past year we have been helping US clients to bridge this gap and we plan to build on this in the future,” “As part of these plans, TRAC is exhibiting at the DIA Annual Meeting in San Diego, US in June. This is a key event in the global pharmaceutical industry’s calendar and will be a real opportunity for us to raise awareness and build upon our current export success.”

Jonathan Trethowan, TRAC Services Company Director

where overall one in three companies had reported a fall in their sales.

TRAC is fully committed to advancing regulatory affairs as a profession within the healthcare sector, both within Europe and worldwide. This is done via proactive involvement with the professional body – The Organisation for Professionals in Regulatory Affairs (TOPRA) and TRAC’s Company Director Jonathan Trethowan is its President for 2014.

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Introduction to clinical trials in Latin America Outsourcing clinical trials to developing regions, has long appealed to pharmaceutical companies looking to reduce their costs and expedite their clinical research

with the number of studies carried out increasing from 52 to 209 in the last decade. Brazil, Mexico and Argentina dominate this area with Panama and Colombia following behind.

Latin America has been tagged as a region of particular interest with clinical trials being conducted in the region for several decades. It is recognised as the place to go to “rescue” your clinical trials when you are struggling to recruit the required number of candidates for late phase trials, but it is not without its challenges.

This accelerated growth in the requirement for clinical trials has caused a change of change of culture in the regulatory authorities, development of ethics committees, new pharmaceutical companies,

The 1990s saw exponential growth in the recruitment and delivery of international clinical studies undertaken in Brazil and Argentina who pioneered the trend.

Mexico soon followed suit as demand grew by the end of the decade.

Clinical research in Latin America has continued to grow

2013

101 3

2010

and Clinical Research Organisations (CROs).

This change of culture has also ensured that developed countries in Latin America have responded positively to the quality requirements and ethical principles required to obtain reliable results for the registration of new medicinal products and medical technologies (pharmaceutical and medical technology).

In Mexico, COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) is the autonomous decentralised agency of the Ministry of Health which carries out the administrative, technical, and operational functions of the state in accordance to article 17 of General Health Law and article 4 of the Mexican constitution.

COFEPRIS was founded in 2001, to establish and implement policies, programs and projects at both a national and an international level.

Accelerated growth for registration records issued to innovative medicine

Ranking

Principal Diseases treated for Clinical Trials Carried in Latin America

Ministry of Health

NAME

Argentina ANMAT - National Administration of Drugs, Food and Medical Technology

1 Cancer

Chile MINSAL-Ministry of Health of Chile

2 Diabetes

Colombia INMIVA-National Institute of Food and Drug Monitoring

3

Gastrointestinal diseases

4

Respiratory diseases

Costa Rica

5

Diseases for the liver

Ranking by disease class covered by trials in Latin America

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Ministry of Health of Costa Rica

Brasil ANVISA – National Agency for Surveillance Health México

COFEPRIS- Federal Commission for Protection against Health Risks

Panamá

Ministry of Health of Panama

Perú

DIGEMID- General Directorate of Medicines, Supplies and Drugs

Venezuela

Ministry of Popular Power for Health

The regulatory bodies in Latin America

Going Global Example Market: Mexico

which guaranteed the safety and efficacy of products, i.e. during both the conduct of the clinical studies and their eventual commercialisation.

Mexico has 120 million inhabitants, some of whom live in its cosmopolitan cities such as Mexico City and are supported by state of the art health care facilities and others reside in its significantly contrasting rural communities. This diversity in both climatic and geographic profiles allows for a variety of complex studies to be undertaken and monitored.

As a result of this approach Mexico was awarded the maximum level “Level-4” certification from the Pan American Health Organization (PAHO) in 2013 and is now referenced as a country for drug registration. This accreditation is currently in the process of Certification with the World Health Organisation (WHO) and has improved the quality and conditions for clinical trials in Mexico, enabling greater transparency and harmonization in all of its clinical research processes.

Because of this diversity and the associated opportunities, COFEPRIS established Mexico as a reference site for the registration of pharmaceutical and medical technology products.

This focus was proactively developed through the implementation and updating of processes and procedures

18,000 16,000

15,499

Research and Development Expenditure to date in the Pharmaceutical Market in Mexico ($ Millions) by Company.

14,000 12,000 10,000

This growth has positively contributed to the research centres move from ad

N° Major Academic Degrees for Clinical Trials in Latin America

1

Degree in clinical trial monitoring

2

GCP´s and ICH regulations

3

Project Management for clinical trials

4

Principal diseases treated in clinical trials

5

Human Healthcare Ethics for better care

9,440

8,000

6,216

6,000

4,611

4,597 4,569 4,500 4,286

4,000

4,151

3,453

3,046

3,021 2,602

2,000

2,384 1,924

1,656

1,354

899

Ab ot t Ba ye r Pfi ze r No va rti s M Sa e r m ck ofi Av Gl ax en oS tis m ith Kl in As e tra ze ne ca No Roc he vo Jo No hn rd so isk n& Jo hn so n Am ge n El iL Sh illy er in -P lo u gh Bo eh rin W ye ge t rI ng h elh eim Ta Da ke da iic hi Sa nk yo

0

Basic Research

Millions of Dollars

hoc units to expert research centres focusing on high level clinical research with highly specialised and qualified staff. Alongside this investment there are now enforced industry standard operating procedures (SOPs), state of the art medical equipment and comprehensive quality programmes currently running in Mexico. Some of these centres have also become more international in their business operations and are now supporting programmes of certification for the European market.

Phases I, II, III, IV

Technology Development

83.39

76.84

79.34 111.81

112.49

132.57

16.75

24.31

31

2007

2008

2009

76.46

79.72

171.48

126.43 3.23

3.77 2010

2011

Research: CANIFARMA (2012)

Principal phases for clinical trial research in Mexico (2007-2011)

Millions of dollars

$300.00 $250.00 $200.00

$251.75

$247.14 $207.90

$213.63

$209.38

$150.00 $100.00 $50.00 $0.00

2007

2008

2009

Emphasis on specialist training in Latin America, indicating courses that are of value to the growing industry

2010

2011

Investment into Mexico for drug development for human use (2007-2011)

Ranking Clinical Research Organisation

1

INC Research

2 PPD

3 PRA

4 THEOREM

5 ICON

6

7 KLIXAR

8 Almac

9

10 Intrials

Worldwide Clinical Trial

Infinite Clinical Research

Top 10 CROs in Latin America

Source: Arturo Rodríguez Jacob, Gustavo Juarez www.infiniteresearch.com.mx and Dr. Gugs Lushai, Medilink South West

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MADE IN THE UK Mediplus celebrates Queen’s Award Mediplus is a family owned business which was established in 1986 to develop innovative, patient centred medical devices within a company philosophy of high quality products, backed by high levels of service.

The company is honoured to have been named as a winner of a Queen’s Award for Enterprise – the UK’s highest accolade for business success. Approximately 150 Queen’s Awards were announced in 2013 for outstanding business achievement

in the fields of International Trade, Innovation and Sustainable Development. The awards are made annually by HM The Queen, and are only given for the highest levels of excellence demonstrated in each category.

Mediplus won the Queen’s Award in the field of International Trade, and this is in recognition of the company’s success in having achieved increased year on year export sales growth for the last six years.

Its export sales, which represent 33% of revenue, are managed via a worldwide network of distributors plus a French subsidiary based in Grenoble.

The investment in education for staff, customers and international distributors is recognised as a key element in the company’s growth strategy. Over the six years covered by the Award, Mediplus’ staff number has grown from 19 to 28 people and the company is looking maintain this growth for the foreseeable future.

www.mediplus.co.uk

Virtual Health wins virtual office in the US SEHTA (South East Health Technologies Alliance) recently funded nine companies to visit Montreal and Boston as part of an EU project (JADE) to expose European assistive technology companies to the US market place and to attend two conferences, the EU-US e-health conference and Partners Healthcare Connected health symposium.

One of the companies which took part in the visit, Virtual Health Ltd, was successful in winning the Innovation Pitch prize in Boston.

The prize awarded consists of one year of serviced office space at One Broadway, Cambridge, Massachusetts which gives Cambridgeshire- based Virtual Health Ltd a US address, a phone number,

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answering service, access to office facilities and meeting rooms.

Virtual Health is also in discussions with the British Vice Consul in Boston to join their mentoring programme aimed at assisting UK companies to secure business and contracts in the US, and has made many new US business and investment contacts alongside all other eight companies on the visit. John Bakker, their CEO, demonstrated their ViSiOrt system. This is technology that remotely captures and transmits live, clinical grade ECG and respiratory waveforms, and other key vital signs, to software on which the waveforms and data can be viewed and which also alerts clinical staff when set parameters are exceeded.

“

John Bakker said: “We are absolutely delighted with the outcome of our participation in the JADE delegation to Canada and the US, it has opened up real opportunities for us in North America which we will work hard to capitalise on. Winning this prize will now give us a significant and practical start in one of the most important healthcare markets in the world.”

www.virtualhealthsolutions.com

Made in the UK

Speedy Breedy speeds up testing Bactest is a Cambridge, UK based company that specialises in turning microbial activity into data. In 2012 Bactest launched its first product Speedy Breedy which is a portable microbial respirometer used for quickly finding contamination in liquid and macerated solids.

Bactest’s laboratory develops and tests specialist media products that make testing for contamination a process that is fast and easy for its customers.

Speedy Breedy is a desktop instrument which has been designed to provide a rapid microbial detection solution.

It takes the processes carried out in the laboratory on agar plates and condenses them, using its patented sensing technology, into a portable, attractive instrument which brings microbiology to the production line.

The product’s simple, out-of-the-box, plug-and-play type design requires no microbiology expertise and this means that anybody can take a sample from the production process, from raw ingredients or from finished product and begin testingcutting out any transport-related delays in obtaining results. Visual and audible cues from the Speedy Breedy alert the user to the detection of contamination or give the “all clear” message.

The sensing technology within the Speedy Breedy means that testing is significantly quicker than when utilising a standard culture process.

Detection of bacterial levels of 1 CFU

(colony-forming unit) per ml of sample can be made in less than 16 hours, with increasingly higher levels of contamination detected notably faster.

For senior Quality Control staff, the Speedy Breedy can be connected to a PC and minute-by-minute data is able to be viewed in real time or downloaded from the instrument itself for in-depth analysis. The Speedy Breedy provides a full digital audit trail which means that it can also be used at the heart of Hazard Analysis and Critical Control Points (HACCP) and CleanIn-Place (CIP) systems.

The Speedy Breedy uses sterile gamma irradiated culture vessels that come pre-filled with specific media to identify contamination by a wide range of bacteria and yeasts. The product has been validated by Campden BRI to find contamination in beer, milk, meat, juice and ice cream trial and the results are available at. http:// speedybreedy.com/community/ trials/

www.speedybreedy.com

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UK Lifescience Industry Magazine

Meeting the Unmet

MEETING THE UNMET B & V Group broadens horizons Innovation focused, B & V Group are broadening their horizons as they diversify from their traditional industrial water treatment activities into the life sciences sector. B & V Group have been able to successfully manufacture next-generation antimicrobial technologies for human wound care, using their extensive expertise in controlling water-borne pathogens. This break-through into the life sciences industry has been further supported by the B & V Training Academy’s launch of new Ofqual accredited training in the control of water-borne infections within healthcare. The B & V Training

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UK Lifescience Industry Magazine

Academy also provides specialist Ofqual accredited training leading to formal qualifications in areas such as the control of water borne infections within healthcare.

B & V Group’s entry into the life sciences sector heralds a new age in collaborative working to reduce the number of water-borne hospital acquired infections. In particular, B & V Group have worked closely with the Life Sciences division within Norland Managed Services, one of the leading facilities, energy and project management providers in the UK & Ireland to establish B & V

Life Sciences, which is able to provide specialist support and consultancy for healthcare premises and hospitals.

Norland Managed Services, Healthcare and Life Sciences Division were also instrumental in working with B & V Training Academy to define and launch their latest course in the “control of water-borne infections within healthcare.”

In addition to the invaluable support provided by Norland Healthcare and Life Sciences, Medilink East Midlands and MediWales have been instrumental in providing the link between B & V Group and the NHS;

Meeting the unmet

academia, industry experts and governmental organisations. This support has been invaluable in aiding validation trials for new products such as Abulox.

Through their unique package of formal training and the development of treatments that eliminate opportunistic water-borne pathogens, including Pseudomonas aeruginosa, Stenotrophomonas species and Legionella pneumophila, B & V Group are leading the way in the battle against water-borne infections within hospitals. They have recently presented at NHS University Trusts on the need to control water borne pathogens, including Legionella and Pseudomonas

aeruginosa. The risk from legionella bacteria is of particular concern for hospitals where individuals with compromised immune systems are most at risk from the potentially fatal, Legionnaires’ disease. These bacteria are commonly found in natural sources of water, such as rivers and lakes where they are generally harmless.

However, within man made water systems, such as cooling towers, they can multiply rapidly at temperatures between 20 to 45°c. If small droplets of contaminated water are inhaled then Legionnaires’ disease may develop.

Initial symptoms are known to include a high fever, muscle pain and chills and once bacteria infect the lungs a persistent cough, chest pains and breathing difficulties may occur.

Legionnaires’ disease is not contagious and cannot be spread directly from person to person. However, with a high mortality rate (10–15% for healthy individuals and close to 50% for high risk individuals, such as immunocompromised patients) the risk presented by legionella in water systems is one we cannot ignore. It is widely acknowledged that large buildings, such as hospitals are more vulnerable to legionella contamination because they have more complex water supply systems in which the bacteria can quickly spread.

Chief Medical Officer, Professor Dame Sally Davies, has taken a special interest in minimising the risk of contamination from Pseudomonas aeruginosa bacteria which can cause significant infections in very sick patients. These organisms are also

becoming more resistant to antibiotics and the latest data from the Public Health England reveals rates for Pseudomonas species at 3,457 with 90% attributed to Pseudomonas aeruginosa.

The production of specialist wound care products is a natural progression for B & V Group, utilising their expertise in manufacturing ultra-pure water and high performance antimicrobials. B & V Group now have an ISO13485 certified manufacturing unit for production of specialist Class III medical devices which will be marketed by Martindale Pharma under their Woundox brand, initially in the area of chronic wounds.

This innovative, rapidly acting and broad spectrum antimicrobial technology is being targeted at helping optimise treatment of venous leg ulcers, diabetic foot ulcers and pressure ulcers treatment which currently cost the NHS in excess of £3 billion each year.

This unique combination of wound care and water treatment technology, supported through a portfolio of formal accredited training, is a major development in the continued fight against water-borne infections.

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UK Lifescience Industry Magazine

CBS Accredited Technology Facility

Central Biotechnology Services (CBS) is a ISO 9001: 2008 certified Technology Facility offering genomics, proteomics and cell analysis/imaging platforms, services and expertise to Cardiff University researchers and external organisations.

• High quality research support

• Managed contract work undertaken

• Proven track record of delivering on commercial and academic projects

• Full bioinformatics support

• Laboratory facilities available Email: CBSAdmin@cardiff.ac.uk

• Bespoke training offered

Email: CBSAdmin@cardiff.ac.uk Tel: 029 2068 7004 Tel: 029 2068 7004 Follow us on Twitter @CentralBioServ

Follow us on Twitter @CentralBioServ www.medicine.ac.uk/cbs

Meeting the unmet

CYPs herald faster drug discovery CYP Design Ltd is a Leicester-based company developing new products and services for drug discovery based on cytochrome P450 enzymes (CYPs).

CYPs are the predominant mechanism for metabolism of drugs and are used extensively in the early stages of the drug discovery process. CYP Design has developed proprietary technology for the expression of recombinant human CYPs, which are more active and more stable, cheaper to produce, and more convenient to use than other commercially-available CYPs. These products are presented in unique Sacchrosomes and are stable at room temperature, thus avoiding the need for a cold chain for shipping and storage, and providing greater convenience for customers carrying out metabolism and toxicity testing.

They can be packaged into any userdefined format including multi-well plates. Stabilised CYPs can also be incorporated into automated lead optimisation workflows to provide metabolism/toxicity information at the same time as activity data. The company is also developing stabilised forms of mammalian liver microsomes, which will retain their full function over a longer time period.

CYP Designâ&#x20AC;&#x2122;s production process is fully scalable, amenable to CYPs from any source (animal, microbial, fungi, plants etc.) and will allow stabilised CYPs to be used in the large scale production of drug metabolites and in industrial-scale biocatalysis.

CYP Design recently announced funding from the Technology Strategy Board to support the development of new products and services.

www.cypdesign.co.uk

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UK Lifescience Industry Magazine

Insight for all NHiS is the leading provider of market intelligence and insight to the medical technology, pharmaceutical and healthcare sectors. NHiSâ&#x20AC;&#x2122;s products assist organisations in their understanding, engagement and optimisation of their markets.

At the core of NHiS is PLEXUS, the most comprehensive data warehouse of NHS and social care intelligence across the UK. The key to PLEXUS lies in the in-depth understanding employed by NHiS when harvesting, interpreting and utilising intelligence. This experience has been mastered through years of pragmatic application and is now harnessed in leading edge technology.

To put it simply, PLEXUS informs and powers all NHiS product sets.

This valuable information has only ever previously been available to academia but now through NHiS is accessible to all.

Two leading NHiS products; Investigator - is an online data resource providing a one stop shop for NHS and social care intelligence in England, Northern Ireland, Scotland, and Wales, helping you to engage more effectively with customers by providing essential up-to-date local knowledge that has been specifically tailored to suit your needs.

Quantis â&#x20AC;&#x201C; is a pre-engineered database of health and social care numerical data utilising Hospital Episode Statistics (HES), Quality Outcomes Framework (QOF) and GP Prescribing data. Quantis holds the power to decipher the needs, and predict the trends, of every local health economy in the UK. NHiS also provide one-off bespoke reports that will answer the unmet clinical need questions to how many patients, where and at what cost to the NHS?

www.nhis.info

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UK Lifescience Industry Magazine

Meeting the unmet

SoundSpace Online: a new initiative at The Ear Foundation

Tel: Fax: www.earfoundation.org.uk

The Ear Foundation is bridging the gap between clinic-based services, where today’s exciting hearing technologies, such as cochlear implants & boneanchored hearing systems are fitted, and home, school and work where they are used in daily life.

with what is required to ensure access and effective management of the latest technology, nor how to address the consequences of hearing loss in daily life from birth through the later years, and in education from preschool to post-secondary.

Hearing loss has a huge, unseen impact in both childhood and later life. For children, spoken communication and literacy development are difficult to achieve without hearing the language and conversations in their environments. For adults, hearing loss makes communication very challenging, often leading to isolation and difficulties at home and work.

Today individuals have access to the latest hearing technologies – digital hearing aids, cochlear implants, and bone-anchored hearing aids – transforming opportunities for children, young people and adults. But all too often, their potential is not reached at home, school or work. Families, users, and professionals are not up to speed

This is where SoundSpace Online comes in. It will provide the information and resources needed to transform opportunities for deaf children, young people and adults. Effectively supporting these individuals with hearing loss involves a range of professionals who need to work collaboratively. To do so requires shared knowledge and easy access to information – something that is not now readily available. SoundSpace Online will fill this gap as the first resource to house access to cutting edge and current information on hearing loss and its management under one roof.

SoundSpace Online looks to serve as an educational resource for all those concerned with hearing loss: parents, users of hearing technologies, professionals and nonspecialists, including policy makers, administrators and funders. It will provide accessible, up to date, accurate and comprehensive information on the impact of hearing loss in a range of domains – including education, medicine, audiology, linguistics, psychology and many areas of science.

The resource will utilise the large range of resources currently available, but which are not easily accessible and are held in a range of websites, making this website the “go-to” place for on-line resources and learning about hearing loss.

www.earfoundation.org.uk

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UK Lifescience Industry Magazine

Life Science Industry Conference, 4th December 2014

The UK HealthTech Conference 2014 is to be held in Cardiff at the St David’s Hotel

Conference Rates:

The one day event will be a valuable day of briefings and networking for those within the life science and health technology communities and research clinicians from the NHS. Over 300 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.

Delegate rate £250 (£175 for MediWales Members)

Seminar topics are set to include:

Plenary sessions:

• • • • • • •

• Anti - Microbial Resistance • Diagnostics and Biomarkers • The Future of Life Science and the Health Technology Industry

MHRA and Regulatory Framework Changes UK Procurement Landscape EU Horizon 2020, Grants for SMEs NICE Medical Technology Briefings Technology Strategy Board Funding NHS Access to Clinical Expertise International Trade Support

Exhibitor Packages £850 (£600 for MediWales Members) Sponsorship Packages from £2,000

For exhibition and sponsorship opportunities or for more information, contact: lucinda.dargavel@mediwales.com, +44 (0) 2920 473456 Visit www.ukhealthtech.com for UK HealthTech 2013 speakers and topics.

Delivered by

UK Lifescience Industry - Event Calendar 2014 April 1

June 3-5

UKTI: Webinar: Healthcare Opportunities in the Netherlands, Online

1

KTN: Electronic Health Records & IT in the NHS, London, UK

2-3

Med-Tech Innovation Expo, Coventry, UK

5-7 8-9

MedExpo Saudi Arabia, Jeddah, Saudi Arabia BIO Asia, Tokyo, Japan

28-30

UKTI: UK-UN Healthcare Supplier Day, Copenhagen, Denmark

29

NHS Commissioning and Procurement: Securing Sustainable Change, London, UK

29

ABHI: The New Public Procurement Legislation Seminar, London, UK

May 1 6 7 7-8 8

14 14

11 23-26 24-25

ABHI: Export Seminar: A focus on Brazil, London, UK UKTI: Webinar: Market Briefing for Hospitalar Trade Fair Mission 2014, Online EuroMedtech 2014, Linz, Austria

EHealth 2014 Athens, Athens, Greece NICE Annual Conference, Birmingham, UK ABHI: ABHI Seminar on UDI Implementation in US, UK and EU markets, featuring Jay Crowley, London, UK Medilink East Midlands: East Midlands Infectious Disease Research Network Special Interest Group, Nottingham, tbc

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

ABHI Export Seminar: Focus on India, London, UK ABHI Communications Seminar, London, UK

July

9-10

Semiconductors for Healthcare Technologies, Sheffield, UK

10

Medilink East Midlands: Food for Innovation, Nottingham, tbc

September 9-10 10

UKTI: Bio partnering Latin America, Rio De Janeiro ABHI Export Seminar: Focus on Russia, London, UK

October

10

ABHI Export Seminar: Focus on Brazil, London, UK

UKTI: ChinaBio Partnering Forum 2014, Suzhou, China Medilink East Midlands: Successfully Selling Using LinkedIN, Nottingham, UK

UKTI: Wound Care Mission to China, China

MediWales: Finance and Funding, Cardiff, UK

NZBIO conference, Auckland, New Zealand

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12-14 13-14

7-11

Medilink East Midlands: The Legal Implications of Social Media, Nottingham

24

Subcon 2014, Birmingham, UK

November

3 3-7

BIO- Europe, Frankfurt, Germany BioProcessing Asia, Langkawi, Malaysia

4

ABHI UK Market Conference, London, UK

12-15

Medica (Welsh Government Mission), Düsseldorf, Germany

25

ABHI Regulatory Conference, London, UK

25-26

BIA: 11th Annual bioProcessUK Conference, Liverpool, UK ABHI Export Seminar: Focus on the Middle East, London, UK

19-21

Saudi Health, KSA

19-20

Precision Medicine Congress, London, UK

20-23 20-21

Hospitalar, Sao Paulo, Brazil

4

UK HealthTech Conference, Cardiff, UK

BioDundee Conference 2014, Dundee, Scotland

9

Genesis, London, UK

21-22

BIO€quity Europe 2014, Amsterdam, the Netherlands

28

Medilink South West: Regulatory Event, UK

29-31

Africa Health, Johannesburg, South Africa MediWales: NHS Procurement and Route to Market event, Cardiff, UK

December

10

MediWales’ Annual Innovation Awards Dinner 2013, Cardiff, UK ABHI Sterilisation and Microbiology Conference, Birmingham, UK

MedilinkUK working together to raise the profile of the life science

industry in the United Kingdom

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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 Abington Cambridge CB21 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)122 535 1562 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

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South East Health Technologies Alliance Tanglewood Well Street Loose Maidstone Kent ME15 0QF Tel: +44 (0)7905 201857 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

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