UK Lifescience Industry issue10

Page 1

Issue 10

United Kingdom

Advances in health technology


Exploring Europe’s life science landscape An examination of the facts and figures behind Europe’s life science industry

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

INSIDE: The best of the UK’s life science and health technology sector honoured at the Medilink UK Awards

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UK Lifescience Industry Magazine


Exploring Europe’s life science landscape

A message from the editor

This edition

What lies ahead? By the end of 2017, the UK will have a referendum on whether or not to remain a member of the European Union. With 28 member states, 503 million people and a gross domestic product (GDP) of over €14 trillion, the European Union is comprised of mature, developed, industrialised economies with an average spend on Issue 5 healthcare that is 10% of GDP.


Awarding success in the UK’s life science sector


2012 ISSUE 4

With this in mind, we decided to take a look at the life Issue 5 science industry in Europe, and investigate the potential impact on UK life science businesses, regulation and Issue 5 investment that could result from the referendum. The region operates as a single market and has a common regulatory framework, for medical technology, in-vitro diagnostics and pharmaceuticals, which allows for products approved by any one national regulator to be marketed throughout the European Union.

2012 ISSUE 4

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Check your dates

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Tess Coughlan-Allen Editor

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An examination of the facts and figures behind Europe’s life science industry


19 West Midlands AHSN working with Health Foundation and NHS England in groundbreaking quality improvement initiative 20 Versatile paediatric standing frame offers 10 years of growth

Future watch

22 Ground-breaking robotics initiative piloted in East Midlands 23 Innovative programme takes the battle against cancer into the community 24 Speedy data improves traumatic brain injury monitoring 25 Leading change in healthcare 26 Wound dressing is easy on the eye

Going global

28 Medica leads to international export for Pro-Lab 29 Introducing innovative rapid diagnostics tests to new markets 30 Laboratory Network continues to expand 31 MasterControl Q&A: Risk management for medical device companies 32 Global expansion for Owen Mumford

Made in the UK

34 ESPRIT, promising easy and less anxious haemodialysis 35 New sterilisation facility for Disposable Medical Instruments 36 Meeting standards for medical device testing 37 Mast Group flying the flag for diagnostics 38 Renishaw launch RenDx platform

Meeting the unmet

40 Smartphone connected biosensors for medical testing without the laboratory 41 PathXL Ltd: delivering digital precision medicine 42 Films fight infection in the workplace 43 Natural solutions combat lung infections in people with cystic fibrosis 44 STOP Pressure Ulcer Day

View an interactive version of this edition at

Exploring Europe’s life science landscape An examination of the facts and figures behind Europe’s life science industry A pan European regulatory framework, funding programmes and cooperation on intellectual property, within a single, large, open market with relative political and economic stability makes Europe an attractive prospect for medical technology manufacturers within the union and across the globe. The combined influence the member states can wield in negotiations with other regions and countries brings benefits to member states and their exporting manufacturers. These strengths are balanced by the challenge of an often slow legislative and regulatory process and a onesize-fits-all approach to policy and economics, which can be stretched when seeking to accommodate the multiple cultures, economies and healthcare systems within the European Union. On balance, most companies value the opportunities that location within the European Union provides.


UK Lifescience Industry Magazine

The European Union comprises 28 member states, 503 million people and a gross domestic product (GDP) of over €14 trillion. 19 of the countries use the euro as their official currency. The region operates as a single market and has a common regulatory framework for medical technology, in-vitro diagnostics and pharmaceuticals, which allows for products approved by any one national regulator to be marketed throughout the European Union.

companies and generates €1,8784m in revenues. The pharmaceutical sector comprises fewer but larger companies, employing 700,000 people and turning over €160,603 per annum.

The countries of the European Union mostly have mature, developed, industrialised economies. The average spend on healthcare is 10% of GDP which represents 27% of global spending. 17% of this money is spent on pharmaceuticals; 7% on medical devices and 1% is spent on in-vitro diagnostic tests.

In recent years the sector has been impacted by the global economic downturn. Medical technology market growth rates have fluctuated between 1 and 5%; in-vitro diagnostic market growth has fluctuated between -2 and 4% and the pharmaceutical market has shrunk by -2% per annum.

The European medical technology sector employs 575,000 people in around 25,000 companies and generates annual revenues of around €100,000m, which is 28% of the global market. The European biotech industry employs 55,052 people in 2,083

With a positive trade balance of €15bn, the European medical technology sector compares well with the 0US surplus of €5bn. Top European medical technology export destinations are the United States, China and Japan.

In addition to the global economic climate that has created an uncertain funding environment, pressures on the market include cost containment measures taken by healthcare providers aimed at mitigating the effects of demographic change and the

European Union life science data:


around €100,000m, which is 28% of the global market. The European biotech industry employs 55,052 People people in 2,083 companies and generates €1,8784m in revenues. The pharmaceutical sector comprises fewer much larger companies, Member States employs 700,000 people and turns over €160,603 per annum.



The European medical technology sector has a positive trade balance Gross Domestic of €15bn which compares well Product with a US surplus of €5bn. Top European medical technology export destinations are the United States, China and Japan.

€ 19

Countries use In recent years theeuro sector has been the

impacted by the global economic downturn. Medical technology market growth rates have fluctuated between 1 and 5%; in-vitro diagnostic market growth has fluctuated between -2 and 4% and the pharmaceutical market has shrunk by -2% per annum.

biotech industry


In addition to the global economic climate that has created an uncertain funding environment, pressures on the market include cost containment measures taken by healthcare providers aimed at mitigating the effects of demographic change and the cost of new products, technologies and drugs and growing global competition.

27% Demographic economic drivers include increased life expectancy and an aging population, as well as increasing obesity and its associated heath problems. Emerging global markets are set to increase trade opportunities and technological advancements in ‘big data’ and genomics are set to drive growth in the areas of precision medicine, diagnostics and e-health.

10% of GDP

The European Union boasts an admirable pan-region partnership approach to research and development initiatives leading to a mix of public and private finance which bridges the funding gap in the commercialisation of research and has contributed to 10,000 new medical technology patents, 5,400 patents and 5,400 patents for biotechnology being filed each year.

Average spend on healthcare

575,000 employees

The European Union legal framework for medical products is intended to promote the functioning of the internal market. To guarantee the highest possible level of public health protection and secure the availability companies of medicines to patients, medical products are regulated by legislation, which is developed in Europe. Directives are then transposed into national law and enforced by regulatory agencies. A CE mark signifies that a product conforms to the Directives. In addition, the system is supported by a Europe wide regulatory agency in charge of providing the EU institutions


European life science figures bysector

However there is a strong argument to suggest that there as many reasons to see greater growth in the European market in coming years.

United States

of global spending with scientific advice on medicinal products - the European Medicines Agency based in London. spent on



As well as regulations specific to medical products, other directives may also impact on a CE marking requirements. The Packaging & Packaging Waste (PPW) Directive, spent on Waste Electrical & Electronic medical Equipment (WEEE) Directive, devices Restriction on use of Hazardous Substances (RoHS) Directive and the legislation on Registration, Evaluation and Authorisation of Chemicals (REACH) can all be spent on in-vitro applicable to medical products.




While the European Union operates as a single marketplace, purchasers and procurement routes can vary widely depending on country, product type and contract value. National, regional and local procurement mechanisms are employees used and reimbursement can be from public health services, private provides and insurance schemes. Pharmaceutical The UK’s NHS is the largest single healthcare delivery organisation and as a consequence it has a complex structure with both national and local companies drivers.




Since cost containment has emerged as a priority for all healthcare providers Health Technology Assessment (HTA) has come to the fore as the favoured method of employees product or service appraisal. Such assessments examine the elements Medical Technology of cost, efficacy, and patient benefits that a product or service will deliver along with how it compares to other options available. HTA is part of the wider discipline of health



25,000 companies




global market share

Top European medical technology export destinations UK Lifescience Industry Magazine


cost of new products, technologies and drugs and growing global competition. However, there is a strong argument to suggest that there are as many reasons to see greater growth in the European market in coming years. Demographic economic drivers include increased life expectancy and an aging population, as well as increasing obesity and its associated heath problems. Emerging global markets are set to increase trade opportunities and technological advancements in ‘big data’ and genomics are set to drive growth in the areas of precision medicine, diagnostics and e-health. The European Union boasts an admirable pan-region partnership approach to research and development initiatives leading to a mix of public and private finance, which bridges the funding gap in the commercialisation of research and has contributed to 10,000 new medical technology patents, 5,400 pharmaceutical patents and 5,400 patents for biotechnology being filed each year. The European Union legal framework for medical products is intended to promote the functioning of the internal market. To guarantee the highest possible level of public health protection and secure the availability of medicines to patients, medical products are regulated by legislation, which is developed in Europe. Directives are then transposed into national law and enforced by regulatory agencies. A CE mark signifies that a product


UK Lifescience Industry Magazine

healthcare delivery organisation and as a consequence it has a complex structure with both national and local drivers.

European Union new patents each year


New medical technology patents


New pharmaceutical patents


New biotechnology patents

conforms to the directives. In addition, the system is supported by a Europe wide regulatory agency in charge of providing the EU institutions with scientific advice on medicinal products - the European Medicines Agency, based in London. As well as regulations specific to medical products, other directives may also impact on a CE marking requirements. The Packaging & Packaging Waste (PPW) Directive, Waste Electrical & Electronic Equipment (WEEE) Directive, Restriction on use of Hazardous Substances (RoHS) Directive and the legislation on Registration, Evaluation and Authorisation of Chemicals (REACH) can all be applicable to medical products. While the European Union operates as a single marketplace, purchasers and procurement routes can vary widely depending on country, product type and contract value. National, regional and local procurement mechanisms are used and reimbursement can be from public health services, private providers and insurance schemes. The UK’s NHS is the largest single

Since cost containment has emerged as a priority for all healthcare providers, Health Technology Assessment (HTA) has come to the forefront as the favoured method of product or service appraisal. Such assessments examine the elements of cost, efficacy, and patient benefits that a product or service will deliver along with how it compares to other options available. HTA is part of the wider discipline of health economics, which is concerned with issues related to efficiency, effectiveness, value and behaviour in the production and consumption of a healthcare system. Along side appropriate trials data and CE marking, a strong health economic case is important for success in the European health technology market. Despite market access criteria, it is still anecdotally recognised within the sector that it is faster, cheaper and easier to introduce medical products into the European market that it is into the US. Before the end of 2017 the UK public will be invited to vote in an in/out referendum on UK membership of the European Union. Individual reasons for voting in either direction will be varied and involve much wider issues than a specific technology market. However, with so many factors to consider and with such a significant potential impact on UK life science businesses, manufactures and healthcare providers would be well advised to consider the effect of the referendum on the regulation and investment and funding of their sector.

References: Biotechnology Industry Report, EY, 2014 European IVD Market Statistics Report, EDMA, 2013 Global life sciences outlook, Deloitte, 2014 Industry Focus vol. 147, Mizuho, 2014 Life Science Competitiveness Indicators, HM Government, 2015 Manifesto 2015-20, United Life Sciences, 2015 Strength and Opportunity, BIS, 2014 The European Medica Technology Industry, MedTech Europe, 2014 The Pharmaceutical Industry in Figures, EFPIA, 2013 The Revision of the EU Medical Devices Directives, Eucomed 2014

Industry and Government partnering to improve transparency


ABHI welcomes the Government’s proposed introduction of the Sunshine Rule as an essential addition to the existing industry-led drive for improved transparency and ethical compliance. For the Association of British Healthcare Industries (ABHI), safeguarding and enhancing the reputation of the medical technology industry is critical. Recent media attention has brought ethical behaviour between industry staff and clinicians to the forefront. To improve transparency, trust and integrity in those relationships, Government has proposed the introduction of a clinician-focused Sunshine Rule.

Association of British healthcare Industries

Medtech industry staff and NHS personnel work together in a variety of ways. The ABHI Code has been developed to lead the way in providing robust and comprehensive measures to ensure those interactions are carried out to the highest standards of professional conduct and ethical compliance.

ABHI also operates the Medical Industry Accreditation scheme, specifically designed to improve the training of medical technology company staff, thereby raising standards of services delivered to NHS organisations. ABHI is working with NHS England and the Department of Health on a national registration scheme to broaden this initiative. This will provide an appropriate and proportionate response to address concerns regarding industry personnel within the hospital environment.

By adopting the ABHI Code, an organisation’s interactions and relationships with healthcare professionals remain transparent and are developed to the highest levels of integrity and trust. Code provisions ensure those relationships cannot be misused to influence purchasing decisions. The Code supports practices aligned with national laws and regulations and, once details of Government’s proposal are understood, will provide an industry framework to complement the Sunshine Rule.

ABHI is committed to working with NHS England and the Department of Health to develop and enhance measures to improve transparency, ethical conduct and trust.

ABHI welcomes this proposal as a significant addition to existing industry-led business conduct standards. The key tool in delivering that is the ABHI Code of Business Practice, which is mandatory for its members.


Industry self regulation delivered through the rigorous, and robust mechanisms of ABHI’s Code of Business Practice, means interactions between industry and healthcare professionals remain honest and professional.

Key principles of the ABHI Code of Business Practice:



The Principle of Separation: interactions between industry and healthcare professionals must not be misused to influence through undue or improper advantages, purchasing decisions, nor should interactions be contingent upon sales transactions or use or recommendation of products


The Principle of Transparency: interaction between industry and healthcare professionals must be transparent and comply with national and local laws, regulations or professional codes of conduct


The Principle of Equivalence: where a healthcare professional provides services, remuneration must be commensurate with, and represent fair market value for, the services performed


The Principle of Documentation: where a healthcare professional provides services, there must be a written agreement setting out the purpose and scope of the services as well as the remuneration to be paid. UK Lifescience Industry Magazine


MEDILINK UK AWARDS 2015 The Winners The best of the UK’s life sciences and healthcare technology sector have been honoured at the 2015 Medilink UK Awards.

The nominees were drawn from winners of regional awards across the UK, selected by panels from Medilink UK member organisations.

Former Winter Paralympian and World Cup Skier Sean Rose compered this year’s Medilink UK Awards, which returned to Coventry’s Ricoh Arena for the Med-Tech Innovation Expo on 29th April. It was another opportunity to celebrate the past year’s cutting edge technologies, outstanding business achievements and international success across the UK’s life sciences sector.

Winners from the five award categories were all honoured at the prestigious event, with two runners up from each category also being highlighted. The winner of the Nabarro StartUp Award was Sheffield-based Swellaway, for their portable selftreatment device which applies cold, heat and compression to human or animal’s joints and muscles. They

have already secured a £1.7m contract with a leading equine distributor, and their turnover is set to increase rapidly as they expand into the human treatment market. The two runners up for this category were Birmingham-based Aston Eyetech and Aylesbury-based The Diabetic Boot Company. London-based The Learning Clinic won this year’s News-Medical. net Innovation Award for their revolutionary software system, which allows clinicians to capture patient data on iPods and iPads in real time at the bedside. They have had remarkable results across the 45 NHS and private hospitals where their software is being used. Nottingham-based Snowden Healthcare and Leeds-based Brandon Medical were the two runners up in this category. The 24/7 Exhibition Services Export Achievement Award was awarded to Birmingham-based NutraHealth Group. NutraHealth,

Start-Up Award winners, Nabarro receiving their award from Sean Rose


UK Lifescience Industry Magazine

Stirling-based Dolby Vivisol and Denbighshire-based MicroVisk were named runners up in the category.

News-Medical. net Innovation Award winners, The Learning Clinic receiving their award from Sean Rose

UK manufacturers and distributors of vitamins, minerals and food supplements, experienced a 53% increase in the amount they exported in the last year. The runners up for this category were North Yorkshire-based Principle Healthcare International and Swansea-based DTR Medical.

The Devices for Dignity (D4D) Partnership with the NHS Award went to Lancaster-based Veraz Ltd. Their flagship product, the VeraMedico System, has led to a 200% improvement in hand hygiene in the NHS, which is one of the main ways to reduce the spread of infection. Staff using the system have an LED light on their badges which shows their current hygiene status.

Bootle-based Mast Group Ltd won this year’s coveted BioHub Birmingham Outstanding Achievement Award. The company is a market leader in manufacturing and supplying diagnostic products that are mostly used for the detection and diagnosis of infectious diseases. Their Mast Uri system has halved the time it takes to tell if a patient has a urinary tract infection, and can also tell the clinician the name of bacteria causing the infection and which antibiotics will be effective against it. The runners up in the category were Oxfordshire-based Novarix and North Yorkshire-based GBUK Ltd.

“As Chairman of Medilink UK, one of Great Britain’s largest healthcare technologies representative bodies, I have seen tremendous strides made over the last year to further develop the organisation to better serve regional SMEs. The Medilink UK Awards provide a wonderful example of the strength and diversity of our sector – as well as celebrating the achievements of companies who are at the forefront of patient care and provide considerable wealth generation to the UK economy.” Gary Stapleton Medilink UK’s Chairman and Business Director of 3M Health Care Business Group, West Europe

The Devices for Dignity (D4D) Partnership with the NHS Award winners, Veraz Ltd. receiving their award from Sean Rose

UK Lifescience Industry Magazine


Launch of Medilink South West “We were excited to mark the next stage of Medilink South West’s journey. It was fantastic to see so many familiar faces in a room with such a great buzz.

Over 80 of the South West’s top clinicians, academics and businesses from across the region gathered at Leigh Court, Bristol recently for the launch of Medilink South West, the region’s premier life science and healthcare industry network. Medilink South West provides knowledge and support to businesses to help them grow and maximise opportunities within the life science and healthcare network. Its role is to bring together the NHS (clinical need), academia (technology), business (innovators, suppliers) and investors to drive industry competitiveness. The launch opened with a welcome from Professor Richard Luxton, Chair of Medilink South West, followed by short presentations from Gary Stapleton, Director 3M Health Care Business Group and Chairman of Medilink UK and Kevin Kiely, Joint Founder and Managing Director of Medilink Yorkshire & Humber who spoke passionately about the work

“I’m delighted to be involved in this unique member led organisation. My task is to re-energise and lead Medilink South West by spreading the word and providing access to advice, support and information.

of Medilink UK and how it’s actively helping businesses. Medilink UK Award winner, Dr Xiabing Huang, Managing Director, Moor Instruments Ltd spoke enthusiastically about his membership experience of Medilink South West and how it has helped him to make the right connections and access advice and support on funding. Commenting on the launch, Carolyn Bruce-Spencer, Managing Director of Medilink South West said:

“Business West, the University of the West of England, the South West Academic Health Science Network and the West of England Academic Health Science Network are working closely together in order to make this organisation a success for members and other stakeholders. I look forward to helping grow this unique organisation.” For further information on Medilink South West please contact Carolyn BruceSpencer on carolyn.bruce-spencer@ or 07794 406 864

SEHTA 2015 Regional Business Awards at KSS AHSN Expo & Awards 2016 SEHTA will be partnering with Kent Surrey Sussex Academic Health Science Network (KSS AHSN) at their Expo & Awards 2016 in London at the Lancaster Hotel, Lancaster Gate on Tuesday 19th January 2016. Alongside working with the KSS AHSN to help with the programme and promote the event to their members, SEHTA will be holding their Regional Annual Business Awards. As part of Medilink UK, SEHTA is pleased to celebrate excellence by organising its annual regional competition to select the best achieving companies of 2015 in 5 categories:



Export Achievement






Outstanding Achievement


Partnership with the NHS

UK Lifescience Industry Magazine

Nominations are open for each category from Monday 5th October 2015 and close at 5.00pm on Friday 4th December 2015. You may nominate your own company or another company with their permission, providing they have an office or lab/ workshop based in London, Kent, Sussex, Surrey, Hampshire, Berkshire, Isle of Wight, Buckinghamshire, Oxfordshire, or Milton Keynes and fit the definition of a Small or Medium-sized Enterprise, then they are eligible. Regional short-listed entries will take part in the KSS AHSN Expo and Awards on Tuesday 19th January 2016 where they will receive an opportunity to exhibit and where the winners will be announced. Regional winners will participate in the MedilinkUK National Awards competition and national winners will be celebrated at one of Europe’s largest healthcare innovation events during Spring 2016.

The winners of the 2014 SEHTA Regional Awards were: Export Deltex Medical Innovation The Learning Clinic Outstanding Achievement Novarix Partnership with the NHSDolby Vivisol Start-Up The Diabetic Boot Company

Positive impact of skills support A multi-million pound commitment to supporting wider skills development within the life sciences industry is already making a positive impact for UK businesses. To keep pace with the high standards set by other leading economies, last year the UK government created the Science Industry Partnership (SIP), which looks to empower employers to identify ways of attracting the best young people, while ensuring the existing workforce has the required skills to develop.

Through an agreement reached with the SIP, Medilink UK has played a key role in delivering a package of vocational training and skills interventions to businesses within the MedTech sector. The original intention of SIP was to create over 5000 Workforce Development opportunities, SIP will also deliver over 1000 apprenticeships, 240 Traineeships and 150 Industry Degrees.

One business looking to embrace wider skills development is Sheffield-based Fripp Design and Research, for who consultancy messaging is key. If their messaging isn’t targeted then it leaves customers

confused as to what they can expect to be delivered. This situation led Fripp cofounder, Steve Roberts, to a review of its whole approach to marketing and overall sales strategy. Steve explained: “Fripp Design and Research is primarily an industrial design business, however, the needs of those customers is very different to customers that would be interested in our 3D Print Technology and 3D Print silicone. “Fripp were using the same social media and communication methodologies, which confused customers, who weren’t sure whether we were an industrial design business or a 3D printing business.” In a bid to address these perceived issues, Steve undertook the dedicated Social Media Skills training programme. Developed and delivered by Medilink specifically for the Healthcare Technologies sector, the programme looks to provide the skills development needed to contribute to the growth of an organisation by empowering them to create an online communications strategy, which impacts on their bottom line, in the process supporting the development of employees’ careers. Steve added, “The skills programme has allowed Fripp to focus on the importance of sending the right communication

messages to the right audience, using the correct media and as a result, the quantity and quality of enquiries has certainly gone up.”

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Leading the way to a brighter and healthier future Research Excellence - Skills and Workforce - Commercial Expertise

Swansea University is home to a thriving cluster of innovative life science and healthcare ventures, offering a full range of support and collaborative opportunities for businesses across two stunning campuses: Centre for NanoHealth (CNH)

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School of Management

Institute of Life Science (ILS) at Swansea University Medical School

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For more information visit or contact

Swansea University, Swansea, Wales, United Kingdom

We innovate healthcare At Roche our aim is to improve the health, quality of life and well-being of people around the world by providing an innovative range of diagnostic solutions and medicines. Roche is a global, research-focused healthcare company with Group Headquarters in Basel, Switzerland. Our strategy is clear - the patient lies at the heart of everything we do and our focus is fitting the treatment to the patient through prescription pharmaceuticals and in-vitro diagnostics. What makes Roche distinctive is our pursuit of excellence in science as we deliver the best solutions for healthcare professionals and improve patient outcomes; this is achieved through our unique combination of Pharmaceuticals and Diagnostics. Everyday, our products help patients and the healthcare professionals who care for them by detecting, preventing, diagnosing, treating and monitoring diseases. We are proud to have played a pioneering role in UK healthcare since 1908. Today, we are the leading in-vitro diagnostics company in the UK and the leading provider of pharmaceutical treatments for cancer and viral diseases. We are also a major supplier of medicines for the treatment of transplantation, virology, bone and rheumatology and renal anaemia. In total, our UK pharmaceutical and diagnostics businesses employ nearly 2,000 people.

Personalised Healthcare We combine our strengths in pharmaceuticals and diagnostics to better fit treatments to patients. When genetic differences can be identified, the efficacy and safety of medicines can be improved enormously. To this end we have a companion diagnostic strategy for every molecule we develop.

Diagnostics As the UK leader in diagnostics solutions, we offer a uniquely broad and innovative portfolio of products to patients, physicians, researchers, hospitals, laboratories and universities. Our UK Diagnostics business, headquartered in Burgess Hill, West Sussex, employs approximately 500 highly skilled individuals. Diagnostics is set to play an increasingly important role in the future of healthcare as genetic knowledge presents new and exciting opportunities. Our desire is to provide clinicians and patients with Actionable Health Information - information that reduces the uncertainty in the medical decision making process, enabling them to choose between available alternatives to prevent or treat disease.

Tel: +44 (0)1444 256000


At Roche we focus on developing medicines and diagnostics that will help patients live longer, better lives UK Lifescience Industry Magazine





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One Conference - Two Essential Streams

• Pharmaceutical Development

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Life Science Industry Conference 1st December 2015 St David’s Hotel, Cardiff, Wales

UK HealthTech Conference is 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 come together to understand critical strategic trends that will impact on their businesses. The event offers the latest insights from key opinion leaders and the unique opportunity to engage with industry colleagues to network and develop your business relationships.

BioPharma Development Seminar Stream • Patient centred healthcare and precision medicine

• Rising to the challenges of innovation & regulation of medicines supply chain • Accelerated access for new medicines and a streamlined approach to clinical development

• Corporate finance and fundraising for life science

Medical Technology Seminar Stream

• The impact of regulatory changes - medical device directive and IVD directive from the MHRA

• Market access - UK procurement and an update on new and innovative initiatives

• Clinical innovation in the NHS - meeting the unmet need • Funding for R&D and clinical trials

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The value of diagnostics:

Using IVD’s can make a difference in reducing antibiotic resistance Seventy percent of clinical decisions are based on an in vitro diagnostic (IVD) test. These have an increasing role to play to deliver cost effective healthcare and improve outcomes for patients. The use of IVDs can significantly support the reduction of antibiotic resistance by: • Supporting antibiotic stewardship • Differentiating between bacterial and viral infection • Rapidly identifying cause of infection to allow targeted antibiotic usage • Monitoring infection levels during treatment

Diagnostics; making a difference

ENHANCEMENT Pharmacy at your fingertips theGPService is a platform that allows pharmacies across the UK to provide a doctor service from within its pharmacy. The service allows patients to select and complete a questionnaire based on standard conditions listed on the website, or consult with a doctor face-to-face for conditions that are not listed. A prescription is then electronically sent to the pharmacy that the patient has nominated. The pharmacy is able to dispense the order and advise the patient when the item is ready to collect or is being delivered, depending on the option the patient has chosen. The technology was created by a group of pharmacists and doctors who collaborated to create an innovative way for patients to manage their health and

provide instant access to a doctor. The system is a response to the continuous financial pressures and growing rise of services within pharmacies, and increased waiting times for patients. The increasing difficulty for patients to get an appointment with a doctor is a key issue driving forward the platform, and theGPService has been building its network to allow patients to have instant access to a doctor. The support provided by Medilink East Midlands (IAG project) has allowed the company to build the application, which is now live with 150 active pharmacies. The company has been working with De Montfort University MBA Department in the initial research and development phase to structure the set up and build the application.

On average, patients in the UK wait 2 weeks to see a GP doctor, and the average waiting time of an appointment in London is 2 hours. In some areas, the waiting time can be anywhere from 4-6 weeks, and pharmacies are finding that there is a need to provide a new and improved service. The concept is based on a doctor being able to assess a patient’s request and provide advice or a prescription within one hour.

During this time, researchers focused their attention on how the new system could create electronic prescriptions whilst incorporating a doctor’s method of private prescription, and the associated security requirements that come with it. The IAG has provided support for the development of theGPService, allowing for quicker and easier commercialisation of the product whilst helping to identify new opportunities within the sector. The IAG assisted with the development of company strategy, improving the overall business processes and helping to build valuable IP. Medilink EM offered further valuable advice throughout the process, providing extremely useful assistance and support. The current pharmacies are listed in London, with an additional 50 in Bolton, and the platform is due to roll out nationally after the successful pilot study. The system has had an excellent response from both patients and pharmacies, and works particularly well in London, fitting with the fast paced lifestyle. The company anticipate further growth and engagement as the platform builds and is expanded nationally.

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Algeos kits out new NHS Greater Glasgow and Clyde super hospital

This includes supplying a large number of items for the new O&P workshop. The team at Algeos carried out a comprehensive site survey in order to scope out requirements for the new hospital’s orthotics and prosthetics department.

Leading medical products distributor Algeos has been selected to provide a state-of-the-art children’s hospital with a range of equipment and products. Liverpool-based Algeos is supplying the new Royal Hospital for Sick Children in Glasgow, which forms part of one of the biggest hospital campuses in Europe. The £850million campus ensures that adult, children’s and maternity services are all on the same site. Algeos is providing a range of equipment and materials covering orthotics and prosthetics, podiatry and physiotherapy.

The new campus, which has opened in phases, brings together the Southern General, Victoria Infirmary, Western Infirmary and Yorkhill sites. Ian Adam, Paediatric Orthotic Rehabilitation Technician at the Royal Hospital for Sick Children said, “The new site consolidates all services in one place – adult, children and maternity. This also means that, for the first time, we have brought together all allied health professionals in one department in the same location.” The adult hospital has over 1100 beds, while the standalone children’s hospital has more than 250 beds. There are also two A&E departments, a maternity

“It has been exciting working with Glasgow from the initial scoping out to now seeing the new hospital come to fruition. In addition to our work with the hospital, we also have a longstanding relationship working with O&P students at the University of Strathclyde.” Max Sheridan Sales Director Algeos hospital, a central laboratory and a dedicated teaching centre on site. Ian added: “Algeos has been an important partner in our move. We have worked with them for more than 20 years and their product portfolio has increased significantly. Although they are global, they remain a very personal company. “We first spoke to them about the new site two years ago and they invested considerable time scoping out the project to determine our precise needs.”


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Innovation surgeries improve interaction between industry and the NHS Working together to improve interaction between industry and the NHS, Kent Surrey Sussex Academic Health Science Network (KSS AHSN) and South East Health Technologies Alliance (SEHTA) have held a number of ‘innovation surgeries’ for health technology companies hoping to bring their innovative products into the market. The innovation surgeries allowed the exchange of knowledge and ideas, and have helped companies gain insight into how healthcare funding might impact on their plans to sell to the NHS. The aim of the surgeries is to improve market access and to enable patients to benefit more quickly from innovative products, treatment and technology.

Rob Berry, Head of Innovation at KSS AHSN, and Dr David Parry, SEHTA’s CEO led on the joint initiative, and together have a vast knowledge of experience working with the NHS, industry and the higher education sectors. Companies based within or near to Kent, Surrey and Sussex were offered the chance to attend a free one-hour surgery session to explore their proposition and gain valuable insight into how to approach healthcare purchasers. The surgeries are aligned with the national Accelerated Access Review, which seeks to address tensions between different aspects of the health and care system. One recognised area of difficulty is the question of financing investment in innovation. The reality of the current NHS system of a fixed one-year budget increases competition for health care resources and limits the ability to invest now for future benefit. Coupled with the findings of the recent report by IPPR “Improved

“Many companies understandably believe that a product offering patient benefits should be of interest to the NHS. However, not having a thorough knowledge of how cash flows around the health and care system can significantly affect the likelihood of products being purchased. Furthermore, the current financial climate means that many technically capable technologies may now be unaffordable, even if there is a credible evidence base and early sales. Successful innovation is much more than simply technologies delivering desirable outcomes. Affordability – realisable savings in excess of the investment and achievable within existing NHS contract mechanisms – are just as important for widescale uptake.” Rob Berry Head of Innovation KSS AHSN

Circulation: unleashing innovation across the NHS”, which highlights the problems of accessing information, it is little wonder that companies can find selling even ‘proven’ technologies to the NHS a challenge. These surgeries offer a chance to improve interaction and engagement between NHS and industry to aid innovation and adoption.


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West Midlands AHSN working with Health Foundation and NHS England in groundbreaking quality improvement initiative The West Midlands Academic Health Science Network (WMAHSN) has recruited the inaugural participants of a ground-breaking new initiative to improve the quality of healthcare. The Q initiative, run by NHS England and independent healthcare charity the Health Foundation, will connect people dedicated to improving the quality of care across the UK. The Q initiative is one of a ‘bundle’ of interventions (including Patient Safety Collaboratives and Sign Up To Safety) that have been launched in response to Don Berwick’s report, published following the Francis report into Mid Staffs hospital. The Berwick report emphasised that the NHS needed to become an organisation that sought out learning when things went wrong, sought out best practice, evidence and innovation, and was able to use techniques to constantly improve the quality and safety of care provided. The Q initiative aims to create a critical mass of quality improvement experts and champions who can work on and promote quality improvement across healthcare in the UK. WMAHSN has put forward ten of the participants who will design, refine and test Q in the West Midlands during 2015. The initiative will then launch more widely in 2016, with the aim to recruit 5,000 participants by 2020. A quality improvement community of practice of this scale hasn’t been attempted before in the UK. Professor Gavin Russell, Theme Director for Patient Safety at WMAHSN said, “Through Q, a diverse range of people in the West Midlands, including NHS clinicians and managers, academics and those with expertise from other industries, will be brought together to radically expand and accelerate improvement to the quality of care. The West Midlands’ participants all have an excellent track record in innovation in healthcare, particularly in safety, and have the ability to bring about change

that will have tangible benefits for patients across the region.” There are 231 people nationally in the founding cohort of Q, ranging from frontline clinicians, managers and researchers to policy makers and patient leaders. The Health Foundation has match funded NHS England and engaged in the design of the programme. This concept of codesign is key to the initiative, as there is no straightforward solution for a programme of this scale. Penny Pereira, Assistant Director of Strategy at the Health Foundation, commented, “We want to ensure the design of Q meets the needs of those working to improve care in the NHS. The overall ambition is to make sure organisations are easily able to tap into the best ideas from across the UK and beyond.” The initiative will make it easier for people with expertise in quality improvement from all parts of the health system to share ideas, enhance their skills and introduce changes to make care better for patients.

“Q will boost the skills of its individual participants, but also encourage a nurturing of talent and sharing of innovation and passion that will be vital as we build the capacity and capability of quality and safety improvement science across the NHS.” Dr Mike Durkin Director of Patient Safety NHS England

The benefit to patients will be derived from the impact on safety and quality improvement culture across the NHS. The view is that the critical mass of Q Fellows will form a wider community of practice to promote the culture of continuous improvement outlined in the Berwick report.


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Versatile paediatric standing frame offers 10 years of growth Sheffield-based Jiraffe are UK distributors of innovative postural support and service products that are introducing the improved Multistander 2 to its range of support equipment from Jenx Ltd. By collaborating with carers, families, therapists and funding bodies, the team have built up over 30 years of experience working with children and adults with special needs. The Jiraffe range covers all aspects of everyday life, including options for seating, standing, mobility, sleeping, therapy and the bathroom. All products are aimed at enabling people to experience a wider range of activities in comfort. The versatile standing frame was recently showcased at Kidz Scotland, an exhibition dedicated to children and young adults with disabilities and special needs. The product is highly versatile and suitable for children from around 9 months up to 13 years across two sizes, providing highly supportive standing. Standing involves many different positions including standing prone (tilted forward), standing supine (supported from behind), or standing upright. The Multistander 2 is adjustable to suit the needs of the user in each of these positions and support their development and functional movement. Although each position offered by the Multistander 2 delivers specific benefits, they all offer greater weight bearing through a child’s legs, helping to strengthen bones. With a wide range of options for adjustment to suit height and width,

and a maximum user weight of 60kg, the Multistander 2 is useful for growing children or multi-user environments. Smooth and easy angle adjustments take the product from horizontal to upright, facilitating easy transfers in position and

an unlimited scope for setting the precise standing angle required for every child. When a child becomes too heavy to lift, the stander can be changed from prone to supine positioning and a hoist is used to transfer the child whilst the frame is set horizontal. This adaptability can remove the requirement for repeat assessments for new products, and dismisses the potential interruption in the continuity of standing development. The product is available in 6 colours with powered or manual base adjustment options to meet the needs of the parent or carer. The powered option removes any manual handling concerns as the motor works to tilt the user to the preferred angle easily and safely, while the manual

option has a more cost effective, robust winder mechanism. The stand is simple to use, ensuring safe and dignified transfers for the user. With a wide variety of head, trunk, leg and foot support options, the product can be customised for each individual user. The open design ensures the visibility of the user’s position to ensure their safe monitoring, with the capacity for outstanding thoracic and pelvic support with highly adjustable leg positioning options. New accessories to support Multistander 2 users include the Multigrip™ Body Support for added shoulder stability and lumbar area support and also the Jenx Waistcoat Harness for maximum trunk control.


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FUTURE WATCH Ground-breaking robotics initiative piloted in East Midlands

A partnership between the NHS and an Italian-based company is pioneering a project that uses robotics to significantly reduce medicines waste and improve patient safety. The Optimed-ID initiative is a partnership between IBSL, based in Italy, and Leicester’s Hospitals. With funding support from the East Midlands Academic Health Science Network, an evaluation of the pilot scheme is currently taking place covering four Renal wards at Leicester General Hospital. A first for the UK, the Optimed-ID tool links electronic prescription with unit dose packing robots and logistics software. The aim is to revolutionise dispensing and tracking of medication by combining several internationally proven technologies into a single solution. The innovation has already demonstrated significant benefits in 20 hospitals in Italy including improvements in patient safety and reduction in medicines waste.


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Ordinarily, a nurse would be used to dispense the drugs on the ward. There may be a particular medicine required and a specific amount needed, but the hospital would need to order an entire box, store it, prescribe it individually, and the reserves could go out of date. This initiative has had a transformative impact, leading to significant cost saving from reducing medicines waste, with only the exact prescription that is required being ordered, and fewer medication errors reducing the risk of patient harm. The system is automatic and reduces error rates from 6% to 0.01%, an incredible improvement that also saves time and releases nurses from ordering and dispensing the drugs, meaning that more time is dedicated to the patient. The system also releases clinical pharmacists from medicines supply and logistics work and leads to improvements in medicines security. Leicester’s Hospitals’ and their partners’ ultimate aim is to create a robotic single dosing facility in the East Midlands,

“The pilot is a first for the UK. As a Trust, we will incur savings through the precise issuing of individual doses of medication rather than patient packs. Our staff time will be better utilised by freeing up a percentage of their time back to patient care, resulting in a richer patient experience. We are hoping to extend this innovative solution which enables improvements in patient safety and reduction in medicines waste using unit dose medicines and bar code assisted medicines administration, across the East Midlands and beyond.” Graeme Hall Deputy Chief Pharmacist Leicester’s Hospitals

benefitting not just patients but also saving the NHS money and supporting inward investment into the region.

Future watch

Innovative programme takes the battle against cancer into the community A series of projects have been announced by the East Midlands Academic Health Science Network (EMAHSN) to move forward new solutions developed to tackle cancer. The projects involve a collaborative effort between the NHS, industry and charities. The three innovative projects follow a ‘call to action’ to identify solutions to one of the East Midlands’ biggest healthcare challenges, cancer. With over 23,000 new cases each year, tackling cancer whilst efficiently meeting the growing demands on health services is a key priority for EMAHSN. The £300,000 award to fund the projects follows a series of region-wide ‘Innovation Exchange’ events that bring together NHS experts and industry to discuss health challenges and identify innovative solutions for rapid adoption, organised by EMAHSN in collaboration with Medilink East Midlands. Within the next year, every county of the region should benefit from breast cancer risk screening, improvements to post-cancer diagnosis outcomes for patients, and moving therapy for bone metastases in cancer patients into the community.

Breast cancer risk screening Increasing access to screening in the community will reduce unnecessary hospital referrals, save costs and lead to quicker detection. Using innovative software called ‘Family History Risk Assessment Software’ (FaHRAS), the project will assist GP’s in determining a person’s likelihood of developing breast cancer, and any requirement for a secondary care assessment, within primary care settings. The tool improves levels of detection for patients who need it most whilst significantly reducing inappropriate referrals to specialist hospital-based services.

Improving post cancer diagnosis outcomes for patients By implementing the Holistic Needs Assessment (HNA) tool in a consistent electronic format, this project will support healthcare professionals from the NHS, social care, charities and carers to provide seamless care for people who have a new cancer diagnosis. This is first time the tool will be available electronically, enabling rapid sharing with all parties involved in care of the patient, and offering patients the opportunity to complete the assessment themselves using an iPad, or with the support of a healthcare professional. The assessment can take place in community or hospital settings and will help provide improved planning and delivery of care services. Patients can identify unmet needs, such as pain management, and the tool should improve quality of life for many people.

Moving therapy for bone metastases in cancer patients into the community. Denosumab (XGEVA®) is a NICErecommended drug therapy for adults with advanced cancer, given to prevent serious complications where cancer has spread to the bone. This innovation focuses upon moving the administration of XGEVA® from a hospital setting into the community, making it much more convenient for cancer patients as well as saving money for the NHS. On average it is expected to save £58 per administration of the drug and will bring care closer to home for many patients across the East Midlands. It will also help to free up capacity in hospital oncology departments.

“One of the EMAHSN’s key remits is to help implement proven innovations at pace and scale across the region – improving the health of the region and supporting wealth creation. We are particularly excited by the involvement of industry, both small and large companies, and the thirdsector in these projects which mark the start of our cancer programme.” Professor Rachel Munton Managing Director EMAHSN


UK Lifescience Industry Magazine

Speedy data improves traumatic brain injury monitoring A pilot programme involving NHS Greater Glasgow and Clyde and the University
of Glasgow’s IDEAS research group has incorporated Aridhia’s data modelling and analytics expertise to investigate real-time data in patients with traumatic brain injuries. Working with anonymised data from patients in the Neuro-Intensive Care Unit (Neuro-ICU) at
the Institute of Neurological Sciences in New South Glasgow University Hospital, the collaboration aimed to improve the down-sampling of high-frequency patient data to allow additional clinical algorithms to be applied in the future, helping to inform clinical decision-making and ultimately improve clinical practice. Traumatic Brain Injury (TBI) is a growing public health problem

worldwide. The World Health Organisation predicts that TBI will become a major cause of death and disability by 2020. Many survivors have serious and long-term morbidity, placing a significant burden on family and caregivers, so it is imperative that innovative approaches to the collection and analysis of patient data are used to deliver improvements in the diagnosis, planning and assessment of clinical treatment. The IDEAS group wanted to investigate ways to swiftly translate physiological and clinical data modelling into clinical practice. They had developed a down-sampling algorithm using the R statistical package that performs peakto-peak waveform signal processing on Neuro-ICU data. However, running the algorithm on a sample of data for a single patient collected over a 12day period took 16 hours to process, an unrealistic timescale for
researchers who need
to tune an algorithm or develop and compare different models. There was therefore a need to reduce the
time taken to down-sample patient data, so that data collected could be used to inform the medical response to TBI at the bedside. A sample of ‘vital signs’ data, collected from the NeuroICU, along with an existing algorithm, was deployed into Aridhia’s AnalytiXagility data science platform and


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safe haven. These time series data were collected across seven channels, spanning over 470 million rows. Approaching the problem in three steps, the collaborative team firstly reviewed and optimised the algorithm for a single processor, secondly the data storage model, and thirdly the parallel computation of
the algorithm. By employing advanced data processing techniques designed to determine the optimal section size from the data sample, reduce the number of iterations of the algorithm, and exploit the multiple processor cores available in the AnalytiXagility platform by running the algorithm in parallel, the team was successful in reducing the time taken to process the original data sample from 16 hours to 48 minutes. The success of the pilot study has led to further funding being awarded by Innovate UK in order to expand the progress and translate the work done with Neuro-ICU waveform data into a real-time clinical setting. This more detailed project, CHART-ADAPT, will see further development of a data and analytics framework that will enable clinical teams in Neuro-ICU to run physiological algorithms on highfrequency patient data, a significant innovation to address the traditional barriers of translating research into services. By exploiting clinical data in a real healthcare setting, it is hoped that clinicians will be able to make earlier decisions about treatment, and that through reduced length of hospital stay
and in-hospital mortality, it will lead to more cost-effective healthcare delivery.

Future watch

Leading change in healthcare Founded in 2008, Hospital Innovations Limited was established to deliver value-adding, progressive and cost effective medical technologies to the UK healthcare system. Their goal is to distribute a range of specialist technologies for use in orthopaedics and corrective surgery, with an emphasis on addressing clinical need whilst ensuring product safety, quality and efficacy. Hospital Innovations is comprised of six distinct divisions. Each division has a unique focus, but all share a common goal; to deliver value to the UK healthcare system by providing high quality, innovative technologies and address clinical need with outstanding customer support services. With over 30 years of orthopaedic industry experience, Phil Davies founded the organisation, bringing together key individuals within the healthcare industry to provide the company with a wealth of knowledge and experience. Working as a UK distributor for global partners, including two of the world’s leading tissue banks, puts Hospital Innovations in the unique position of being able to supply the UK healthcare industry with personalised, innovative medical solutions that are tailored specifically to the needs of the UK healthcare system. “Unlike most manufacturing companies dominating the UK healthcare industry, Hospital Innovations is uniquely positioned as a UK specific distributor. We are not restricted in our portfolio scope or function; we possess the ability to constantly change to meet the needs of an ever evolving and budget constrained UK healthcare system. This has allowed us to introduce some

has made significant investments in both people and portfolio over the past few years and is poised to enter its next growth phase with a broad customer focused portfolio offering.

In recent years Hospital Innovations has led the way in changing the face of healthcare within the UK: l One of the first private

companies to be HTA certified as a tissue bank, Hospital Innovations introduced the UK’s first allograft return service saving the NHS in excess of £2m over the past 4 years l The first to deliver fully sterilised

allograft tissue to the UK without the use of potentially damaging irradiation

“Hospital Innovations was set up to address the need for growth and development within certain segments in the field of orthopaedics and general surgery. Its formation was underpinned by the involvement of some of the leading figures within the orthopaedic sector at the time. Our directors have over 120 years of combined experience in the medical industry; many of whom have been directors and managing directors of some of the industry’s leading companies, providing the company with new growth opportunities through their extensive knowhow, expertise and global industry collaborations and partnerships,” Phil Davies Managing Director Hospital Innovations

l Supplying the UK’s first nerve

allograft; with the potential to drastically improve nerve damaged patient’s quality of life

truly groundbreaking technologies to the UK,” said Phil Davies, Managing Director, Hospital Innovations. Demonstrating double digit sustainable growth since its inception, with a multitude of innovation and technology business awards, Hospital Innovations

For their future plans, Hospital Innovations plan to continue to innovate and lead change within the UK healthcare system. Having helped develop cutting-edge technologies in the field of orthopaedics, nerve repair and wound management, the company will continue to look at new technologies for the benefit of patients, both in the UK and in Europe.


UK Lifescience Industry Magazine

Wound dressing is easy on the eye NuVision™ is a spin-out company from the University of Nottingham, founded by Dr Andrew Hopkinson, the Principal Research Fellow in Academic Ophthalmology, Division of Clinical Neuroscience. The company was established to commercialise high quality and affordable biotherapies for treating front of the eye disease and trauma. NuVision is based at MediCity, Nottingham and GMP manufacturing laboratories, licensed by the Human Tissue Authority (HTA).

The current method for storing amnion for clinical use is via cryo-preservation at -80˚C. Unfortunately, preservation by freezing and the subsequent thaw process is known to damage the tissue and strip the soluble trophic factors contained within the membrane, and requires heavily regulated cold chain storage and costly logistics, preventing storage at the hospital. Amnion can only be distributed for scheduled surgery once ordered, taking up to 24 hours for delivery on a named patient

end product is Omnigen™, developed to allow easy and direct application onto the ocular surface during conventional surgery and emergency and trauma situations. Its application will be a simple process requiring nonsurgical and suture-free intervention that a non-ophthalmic medical specialist will be able to perform. This entails a sterile Omnigen™ disc being placed on the ocular surface, with a conformer contact lens inserted to hold the membrane in situ. Rapid in

basis, and must be used within 48 hours or discarded. These limitations greatly restrict end user access for scheduled surgery, and amnion cannot be accessed as an emergency therapy for the routine treatment of trauma injuries.

vivo rehydration from eye moisture will initiate the prolonged release of repair inducing amnion constituents and antibiotics during the most destructive initial phase of an injury.

NuVision was formed from, and is supported by, a world leading corneal research group. Their aim is to address key clinical challenges to provide solutions to sight saving problems, meaning that NuVision is the UK’s first ophthalmic biotech backed by such a prestigious academic research group. The company’s launch product is Omnigen™, a biological wound dressing which aids the regeneration and healing of the surface of the eye. The first of its kind, Omnigen™ is a human amniotic membrane-derived dry preserved biological matrix intended for ocular surface surgical and trauma therapy.

Omnigen™ is a unique, transportable biological matrix that can be used as effective ophthalmic wound dressing and to treat ocular surface indications. The product will equip civilian, military and veterinary surgeons tasked with treating damaged corneas with an immediately accessible, consistent, high quality, and reliable product.


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Addressing the practical limitations and quality issues that greatly restrict the clinical potential of existing amnion products, NuVision and the Academic Ophthalmology Department of the University of Nottingham have developed a patented procedure known as the Tereo™ manufacturing process, to standardise the process and preservation of amnion properties in a unique dry and stable format. The

Omnigen™ has been 13 years in development, backed by £2 million of research funding, including significant support from the UK Ministry of Defence, Defence Science and Technology Laboratory. The technology is dual-patented and meets the demand for a product that is both easy to store and accessible in the hospital.

Future watch

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GOING GLOBAL Medica leads to international export for Pro-Lab Attending Medica, one of Europe’s leading international health care exhibitions, led Pro-Lab Diagnostics to secure its largest manufacturing contract to date. With just six weeks to supply 20,000 bottles of staining solution for use by the United Nations in Cambodia, the company had to dramatically upgrade its operations. The Pro-Lab Group of companies was originally established in 1974 in Canada, as a provider of high-quality, cost effective immunodiagnostic products. In 1995, the Pro-Lab

“We calculated that even if we had done nothing else and worked 16 hours a day, the UN order would have taken us four months to fill using our old methods. It took some quick thinking and determination to create a set up that would allow us to achieve 20,000 units in six weeks. Meeting the supplier on the UKTI stand at Medica was the catalyst for us to make these major changes to our operations. We now have time to research opportunities in new fields, such as haematology, histology and cytology.” Mark Reed General Manager Pro-Lab Diagnostics

Diagnostics’ UK subsidiary opened a purpose-designed production facility in Merseyside, the Group’s European headquarters, for the manufacture of staining solutions used to study cells and detect the presence of bacteria in clinical samples. Today Pro-Lab has a turnover of £4.5 million and partners with other manufacturers to offer extensive diagnostic and research related products. Its range includes the Prolex


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latex agglutination systems for strep, staph and E.coli; Microbank for storing and retrieving bacterial and fungal cultures; and microbiological staining solutions. “Microbiology has come a long way in recent years, and we’re proud to offer a comprehensive line of microbiology products, manufactured to the highest quality standards in our own laboratories. As automation becomes more and more successful, staining

solutions will always have their place and play an important role in clinical microbiology investigations,” says Mark Reed, General Manager at Pro-Lab Diagnostics. As part of its marketing strategy, ProLab attends Medica, the world forum for medicine that takes place annually in Düsseldorf, Germany. The company has launched all of its products there over the past 20 years. In 2014, it joined a delegation organised by UKTI and GAMBICA, exhibiting in the UK Pavilion. One of the visitors to the stand was a representative from a leading British supplier of laboratory chemicals, who was putting together a consortium to bid for a United Nations (UN) tuberculosis-screening programme in Cambodia. Its buyer approached ProLab to see if the company would be interested in the tender. Back home in the UK, the supplier visited Pro-Lab’s facility, they won the UN contract and the order for 20,000 units had to be delivered in just six weeks. With capacity at the Pro-Lab production facility at just 800 units per week, it was clear that a huge upgrade would be needed. The company took the opportunity to bring in automated machinery to carry out tasks normally done manually, such as filtering, capping and labelling. With its new automated production line up and running, Pro-Lab has been able to take on and deliver numerous other large orders ranging from 1000 to 20,000 units. The company has also broadened its product range into more areas and attracted orders for these from new and existing customers.

Going global

Introducing innovative rapid diagnostics tests to new markets A simple blood test device developed by Atomo Diagnostics has been transforming the way global killers such as HIV and malaria are diagnosed. Having launched its products in Africa during 2013, Oxfordshire-based Atomo has recently set its sights on expansion into Europe and South East Asia.

The company’s AtomoRapid™ platform folds costly and time consuming blood testing procedures into one easy to use device. The device removes the need for multiple test components and, by simplifying user steps, helps to address errors common with standards rapid diagnostic tests.

The ingenuity of the product was recognised at the 2014 International Medical Design Excellence Awards, where AtomoRapid™ was named ‘Best in Show’. “We have combined a lancet (needle), capillary tube (storage unit) and test strip (results) into one simple and reliable integrated device,” says company founder

and CEO John Kelly. “The healthcare professionals using it find it far more straightforward than other kits, which require assembly.” Kelly, a product development engineer with 15 years medical device company experience, is passionate about the company’s global health and commercial potential. “The big diagnostic companies were not focussed on the HIV, malaria and dengue fever markets, and we felt we had a product that could really make a difference in these fields,” he says. Founded in 2010, Atomo has grown fast; but its competitors tend to be larger and have easier access to funding. Kelly explains, “We have to think smart and target our resources in areas where we can make most impact. This is why we are taking a phased and planned approach to global expansion, rather than trying to go everywhere at once and risk overreaching ourselves.” AtomoRapid™ has been proving itself in front-line HIV diagnostic screening in Africa, where it is reducing the high rate of potentially deadly, false negative HIV test results produced by more complex in-field rapid blood tests. In anticipation of launching the product in Europe and South East Asia, the company is now actively

recruiting specialist distribution partners in these regions. It is expected that supply into Europe will start by the end of the year. Atomo will also be showcasing its products at the Medica trade fair in Dusseldorf, Germany, in November. Kelly explains how, “As the world’s biggest medical trade show, Medica provides a fantastic and cost-effective opportunity for us to present our products to a huge number of potential partners and customers from all over the world.” As appreciation of the AtomoRapid™ platform has grown in the marketplace, and critical regulatory milestones have been achieved, Atomo Diagnostics has gone from strength to strength. Beyond territorial expansion, the company is also adding new test applications to its product portfolio. Earlier this year Atomo announced that it is working with the UK specialist immunoassay development and manufacturing firm BBI Group to provide AtomoRapid™ as the platform for BBI’s Ebola rapid diagnostic test, launching soon in West Africa. AtomoRapid™ also has the potential to revolutionise self-testing, enabling early diagnosis and enhanced patient privacy through at-home testing.


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Laboratory Network continues to expand

Synergy Health, a global supplier of sterilisation solutions and laboratory services has announced the addition of a new Microbiology Testing Laboratory at their Gamma and Ebeam site in Radeberg, near Dresden in Germany in early 2016. With corporate headquarters in Swindon in the United Kingdom, Synergy Health currently operates across 39 sites in 15 countries. The new facility in Germany will support the testing requirements of Synergy Health’s medical device and pharmaceutical business in Germany and Switzerland. The laboratories managed by Synergy Health have been running for 50-years in the Netherlands and for 20-years in the UK and Ireland. The Synergy Health laboratory network currently has 11 laboratories across the UK, Ireland, the Netherlands, Italy, the Czech Republic, Slovakia and Germany and has a global presence. Synergy Health employs over 5600 people across the UK & Ireland, Europe & the Middle East, Asia & Africa and the Americas.


The new facility will support the strong growth in customers from Germany, Switzerland, Austria and Poland using

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this facility in addition to sister sites in Allershausen, Germany and Danikien, Switzerland. The laboratory will be a state-of-the-art facility with the ability to test according to ISO11137. The site will also have Bioburden, Enviromental and LAL testing facilities and a GMP compliant Class 7 Cleanroom. With this new facility, the company is able to maintain their global growth as they expand geographically. Using the experience and knowledge gained from running successful laboratories across Europe, Synergy Health can ensure that the German customer base have access to this high quality facility, at the cutting edge of the regulations. As they continue to progress, Synergy Health hope to add additional service lines as the regulations change, keeping pace with customer needs, whilst continuing to be an acknowledged leader in the provision of sterilisation services using Ethylene Oxide, Gamma and Electron Beam technology, and associated laboratory services. Synergy Health’s strategy is focused on four core elements: expanding the business internationally; focusing on high value-added services; deriving competitive differentiation through their people;

and cost leadership. The international expansion will play an important role going forward, mitigating the impact of economic uncertainties in Europe, and providing opportunities for growth in the faster growing regions of the world. The strategy to extend Synergy’s reach has progressed well with new services in the Americas, Switzerland and Malaysia.

Five Nottingham-based drug discovery companies teamed up with UK Trade “We are pleased & Investment (UKTI) inthe theSynergy hope ofHealth Board has agreed to further discovering Scandinavian sales. invest in the EME Laboratory network and this The businesses to Denmark will supportheaded the strong network on we a market visit entitled, “The Changing already have in the UK, Netherlands, Face of Pharmaceutical Discovery Ireland and Italy, which has supported and Development – A Collaborative the regulatory requirements of our CRO Approach” which provided an customer for overresearch 20 years.” opportunity forbase life science Mark Botting companies across the Nordic region to meetDirector and discuss how collaborative EME Laboratory Business outsourcing can overcome the key scientific challenges within R&D.

Louise Stock, International Trade Adviser for UKTI, led the market visit and said, “Pharmaceutical companies

Going global

MasterControl Q&A: Risk management for medical device companies Global regulatory authorities expect medical device companies to document their risk management activities in one way or another. Many risk assessment methods exist, including Failure Modes and Effects Analysis (FMEA) and Hazard Analysis and Critical Control Points (HACCP), but these methods do not fully satisfy the requirements of ISO 14971, the risk management standard embraced by regulators in all of the major world markets. As the challenges of producing a medical device continue to increase – with complex technology-driven devices, increasing regulatory control and an ever-expanding web of suppliers – many companies struggle to implement an ISO 14971-compliant risk management process. MasterControl, a leading provider of quality management system (QMS) software solutions for regulated industries and ISOcertified companies, clarifies the risk management standard in the following questions and answers.

Q: What is ISO 14971? A: ISO 14971:2007 (“Medical Devices – Application of Risk Management to Medical Devices”) is an internationally recognised standard used by manufacturers as a tool for conducting risk assessment. The US Food and Drug Administration (FDA) recognises it as an acceptable risk management model and the European Union has made it mandatory, releasing its own version that applies to devices intended for the European market (EN ISO 14971:2012). Even if manufacturers choose not to implement ISO 14971, they are still expected to conduct and document a risk management process.

Q: What does risk management mean? A: Risk management in the context of ISO 14971 refers to a process for “identifying hazards associated with a medical device, estimating and evaluating associated risks, controlling these risks, and monitoring the effectiveness of the control.” Hazard means any potential source of harm to the patient or consumer. Risk refers to a combination of the severity of the harm and the probability of its occurrence. Risk control is the process of implementing protective measures for reducing risks or keeping them to a minimum.

Q: Is there a connection between ISO 14971 and ISO 13485? A: Yes. ISO 13485 is an international standard that specifies requirements for regulatory purposes for medical device manufacturers. It provides a framework for companies to meet their customer and regulatory requirements, and outlines the things that they need (e.g. quality management system, resources, management requirements, remedial requirements, etc.) in order to be compliant. ISO 13485:1996 requires risk analysis and records pertaining to risk analysis throughout the design process. ISO 13485:2003 requires the establishment of documented requirements for risk management throughout the product realization process and to maintain risk management records. A note in ISO 13485:2003 refers to ISO 14971 for guidance related to risk management. The latter deals more with principles of risk management – a way of thinking – for manufacturers to fulfill the risk management requirement of ISO 13485.


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Global expansion for Owen Mumford Owen Mumford is a global industry leader in medical device design and manufacturing. Working closely to patients’ needs and healthcare concerns, Owen Mumford’s solutions are used as part of self-management plans and in hospitals, doctors’ surgeries, pharmacies, care homes and clinics around the world. Owen Mumford offers innovations for sampling and drug delivery from a broad base of proven self-injection and blood sampling platform devices and intellectual property. These devices help patients and healthcare professionals deliver effective treatments for conditions such as diabetes, multiple sclerosis and many other therapy areas. With over 85 per cent of its products exported to more than 60 countries, Owen Mumford is committed to bringing life-saving and life-changing devices to new markets around the globe. With the recent opening of its new regional hub in Malaysia, Owen Mumford’s CEO, Jarl Severn, comments on what this means for the business and its growth plans for the future, “Over the last decade, the Malaysian pharmaceuticals market grew at between 8 to 10 per cent


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annually. As the region has seen economic growth, governments have increased their per capita investment in healthcare provision, with APAC countries also reporting a high prevalence of diabetes, Owen Mumford identified the need to make a difference within the region.” “Continued success by the market development team in winning business with customers in Australia, the Philippines, Malaysia, Singapore and Thailand further highlighted the need for a local regional facility to act as a hub to increase our speed and flexibility when supporting potential and existing business within the region.” Several countries were considered before Malaysia was identified as the optimal location. Malaysia was selected as the preferred option due to its relatively stable political environment with a good economy and positive, business-friendly approach. A local company, Owen Mumford Sdn Bhd was set up in 2014, and in early 2015 a location was identified for the regional hub in Nusajaya. The facility was completed at the end of May 2015, and the team are actively working to deliver the vision for Owen

“The long-term vision is to use the Malaysia facility to complement the Owen Mumford global resource footprint and enhance our service levels worldwide. We have a long history of innovation and our mission is to provide solutions that will exceed expectations, encourage compliance and improve quality of life. We export over 85 per cent of our products and as such have many years’ experience in trading overseas.” Jarl Severn CEO Owen Mumford

Mumford Malaysia: developing their presence in the region by growing their business out of this new regional hub. Initially, the Malaysia hub will bring in-house services currently outsourced in the region, allowing them to respond more quickly to customer demands, create bespoke product presentations for private label opportunities and shorten the response time for products to the existing customer base.

European Funding Opportunities and the KTN Horizon 2020, the new European Commission programme which started in 2014, represents a significant opportunity for UK companies to develop collaborations with organisations in other European countries and to access finance for R&D and innovation with a proposed budget in excess of €70bn over a 7 year period. Dr Terry O’Neill Head of Health, KTN

Europe represents the world’s largest international market with 503 million people generating €14 trillion in economic activity. It is a bigger trading area than the US and Japan combined. Europe is therefore a significant opportunity for UK business.

Horizon 2020 is one of KTN’s core Business Programmes and the majority of KTN staff, in all industry sectors, have a role to play in helping to encourage UK companies to engage with the opportunities provided via Horizon 2020. Our activity in this field is led by Claire Claessen, Head of Horizon 2020, in close collaboration with other senior managers across the organisation. Claire’s group also work

very closely with the various National Contact Points on specific theme activity and with the European Enterprise Network (EEN) on the SME Instrument and Europe-wide networking. The Health Team at KTN is currently delivering a set of workshops and webinars designed to engage with UK companies across the sector and to encourage them to consider Horizon 2020 funding. This activity will culminate in a large meeting in Leeds on October 27th entitled “EU research and innovation funding for Health, Demographic Change and Wellbeing - opportunities for successful collaborations in 2016-2017”. This event is being delivered with the NHS European Office, the Academic Health Science Networks and the EEN and will focus on the Health, Demographic Change and Wellbeing themes with specific focus on NHS organisations. Of course, opportunities exist for life sciences companies outside of the Health, Demographic Change and Wellbeing themes and it would be our pleasure to help to navigate your organisation through the, sometimes complex, world of Horizon 2020 as a whole.

If you have comments or questions or you would like to know more about KTN or any of the current or future Horizon 2020 themes then please get in touch with Terry O’Neill, Head of Health at KTN. Email:


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MADE IN THE UK ESPRIT, promising easy and less anxious haemodialysis ESP Technology Ltd (ESP) is an advanced materials and process development company that has developed a novel, early cannulation vascular access graft (VAG) with a low complication rate, for use in patients requiring routine haemodialysis using its proprietary Flexomer™ materials platform technology.

Flexomer™ is a unique materialsprocessing technology creating new forms of perfluoroelastomer (PFE) materials. Flexomer™ takes advantage of the fluorinated polymer backbone of PFE to create a family of polymeric materials that are inert, biocompatible, and exhibit soft, tissue-like physical properties. The versatility provided by this combination of material properties could transform the design and performance of implantable medical devices in multiple fields of application by adding new functionality to existing implants and allowing innovative, performanceenhancing product designs to be created.

The original target products to benefit from Flexomer™ are the vascular access grafts implanted into patients with endstage renal disease, whose kidneys have failed and therefore require lifesaving haemodialysis to filter toxins and metabolic waste products from their bloodstream. A VAG is an artificial blood vessel implanted under the skin that connects an artery to a vein, creating an access point to the circulation that allows the patient to be


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connected to the dialysing machine via insertion of two large bore hypodermic needles into the VAG. Most commercially available access grafts are made from expanded polytetrafluoroethylene (or ePTFE, a generic cloth-like version of Teflon).

Although ePTFE shares the inert and biocompatible nature of PFE, which is a consequence of the same whollyfluorinated chemical backbone, its cloth-like nature does not allow it to recover from the damage caused by needle puncture. This results in significant bleeding under arterial pressure when the haemodialysis needles are withdrawn at the end of the dialysis session. To prevent serious complications that may result from this post-needling haemorrhage, external compression must be applied, however, long or enthusiastic compression may result in thrombosis of the VAG, which requires prompt, expensive surgical intervention to correct. The ESP solution to this longstanding problem is to apply a thin, microcellular coating of Flexomer™ PFE to the outer surface of the VAG. In the laboratory, the

Flexomer™ coating has demonstrated a reduction in fluid loss by over 90%, and during its pre-clinical implant trials, the coating has promoted complete cessation of bleeding, or haemostasis in minutes without the need for external compression. The improvements to patient well-being and the overall health

economics are considerable, and it is estimated that widespread adoption of the Flexomer™ coated VAG, trademarked Esprit™ within the UK could save the NHS around £40 million per annum in surgical intervention and re-operation costs alone. The next phase in the growth for the company has started with a move from Sci-Tech Daresbury to larger R&D laboratories and office facilities at Thornton Science Park in Cheshire. Here the technical team will adapt the Flexomer™ technology to develop improved coatings for orthopaedic implants and optimise the functional additives for antimicrobial and electroconductive Flexomer™ materials, which they intend to introduce to the medical, industrial, military and aerospace markets in due course.

Made in the UK

New sterilisation facility for Disposable Medical Instruments Disposable Medical Instruments (DMI) has recently expanded its business with significant investment in an Ethylene Oxide (EtO) sterilising chamber. DMI is a UK company, working out of its facility in Bury St Edmunds, near Cambridge that provides sterile customised packs of medical instruments and consumables, and customers can order exactly what they want to avoid waste and cost. The new chamber works in 24-hour cycles, handling up to three pallets at a time, each containing the customised packs of disposable medical instruments DMI provides for its clients in the public and private healthcare sector. The company was set up in 2007, when co-directors Yvonne Valentine and Patrick Chaney saw a gap in the UK market for competitively priced, high-quality single-use medical instruments. All products have a guaranteed sterile shelf life of 5 years and the company carries a wide stock, allowing them to quickly turn around orders in a matter of days. Yvonne, Patrick and the rest of the DMI team are involved in every aspect of every order, so each client recieves personal treatment and flexible service.

Items from DMI’s large stock of nonsterile single use stainless steel medical instruments can be purchased directly by manufacturers for distribution, and DMI can contract-pack medical instruments supplied by any manufacturer in its Class 7 medical grade cleanroom. The EtO sterilisation chamber can be used to sterilise any number of medical instruments, from one box to many pallets. The process is safe, efficient and flexible, and sterilises almost any kind of material, including combinations of medical devices, metals, plastics, gauzes and swabs that make up DMI’s bespoke medical procedure kits. EtO sterilisation is ideal for disposable products because it safely sterilises medical and pharmaceutical devices that cannot support conventional high temperature steam sterilisation, such as those that incorporate electronic components, plastic packaging or plastic containers. It works at a low temperature but with high efficiency, destroying microorganisms, including resistant spores.

As well as being a really high-tech piece of kit, the new EtO sterilisation allows the company to do everything under one roof, offering a complete sterilisation, packaging and distribution service, all from its UK factory. It can fulfil large or small orders, controlling every aspect of the process from start to finish, and work with great flexibility. With their new fully in-house capabilities, DMI has greater control of consistency and quality at all stages of work.

“This new EtO chamber, together with our well-established ISO Grade 7 cleanroom, means we now have everything inhouse to grow our business, reduce our carbon footprint and continue to give our customers the cost efficiency, quality and standards they demand.” Patrick Chaney Managing Director Disposable Medical Instruments


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Meeting standards for medical device testing Elite Electronics Systems work on the principle that a comprehensive test regime for medical devices will ensure products are not returned from the market place with faults, inconsistency or poor quality. Customers must deliver to the standards expected by the general public and also to the quality standards and approvals expected by the regulators. Effective and efficient test strategies must be used to embrace a combination of compliant procedures and technical excellence. When manufacturing processes for medical devices are tightly controlled, designing for test has to be significantly resourced from concept. A key phase in any product lifecycle is initial design and to facilitate comprehensive test during production, designers must embrace the whole notion of ‘design for test’.

Importance of design for test from concept:

NPI and production:

Design for test considerations should begin at the start of the design process. A successful test strategy must match test regimes to create parameters that will identify the defects most likely to occur during the manufacturing process. Engaging with a manufacturer that has access to a test house with a good understanding of their manufacturing processes simplifies the manufacturing process substantially.

Engaging with your contract manufacturing partner at the earliest stage of the design process will ensure that the correct design for test and manufacturing considerations have been implemented in the final design. This ensures a smooth transition through NPI into full production. HASS testing then can be implemented at the early stages of production to screen out manufacturing related defects and hone the process.

Validation testing: The medical device industry invests a lot of money in validating designs before going into production. This is best achieved through an ISO170265 approved process, where environmental stress testing (shake and bake), and EMC testing is done to strict industry standards. If design for reliability guidelines are followed, validation testing is normally a seamless process where the failure modes have already been designed out and the product passes first time.

Full life cycle support: With the long life cycle of typical medical devices, and the increasing prevalence of obsolescence issues mid-way through the life cycle, it is imperative to have a reliable test and manufacturing partner to allow for redesign and associated validation testing to be carried out seamlessly when required through the product life. Testing in practise Elite is the supplier of electronics for The Magstim Company, based in Wales. As Magstim developed their products and moved towards scale manufacture, a series of collaborations between Magstim and Elite set out the parameters for the testing required. As Elite provides a sub assembly (i.e. populated PCB’s) for Magstim, they are required to provide testing at board level only. Even at this level Elite and Magstim were involved in extensive discussions about developing suitable test procedures and rigs. In the first instance Elite recommended a series of board level tests, developed suitable test rigs to facilitate these, and sent this to Magstim for validation and approval. Once validated and approved, Elite trained core staff in operation of these specific test rigs and recorded procedures. Elite now has a bespoke test regime for Magstim delivered on a production scale. All test results are uploaded to Magstim, giving them full test coverage on every board Elite produce. This level of test gives Magstim a high degree of confidence in every PCB they use in their system.


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Made in the UK

Mast Group flying the flag for diagnostics The UK owned and based Mast Group is a market leading manufacturer and supplier of diagnostics worldwide for clinical, veterinary and industrial testing. The Mast Group Ltd has been a manufacturer of in-vitro diagnostic products, specialising in Microbiology, for over 55 years and continues to be at the forefront of development in this field. Mast was recently awarded the Medilink North West and Medilink UK Outstanding Achievement awards in honour of their flagship product the Mast Uri®System - an innovative, semi-automated laboratory solution for the microbiological analysis of urine samples. In comparison to traditional bacterial culture based methodologies, the Mast Uri®System offers higher throughputs, simplified processing and rapid turnaround times, while significantly reducing cost and waste. This award win demonstrates the strength and diversity of products within the healthcare technology group. The building of a new factory has now begun, and will offer a modern stateof-the-art facility, which Mast plans to transfer manufacturing to during 2016. The Mast Group is continuing with its programme to invest in

Mast Uri®Systems have been placed in NHS and private pathology groups across the UK. Systems have also been placed in Hungary and in Ireland, and Mast continues to look at developing new markets in Europe and further afield for the Uri®System.

both its manufacturing facilities and further research and development in innovative products to serve the needs of both the national and international markets. UK evaluations of the Mast Uri®System demonstrated significant cost savings when compared to conventional methods, allowing for a considerable improvement in result turnaround time; typically >95% results reported within 24 hours, which is essential within today’s NHS. This enables laboratories to make more efficient and effective use of their staff allowing for approximately 50% of staff time to be re-allocated. The Mast Uri®System is proving to be advantageous in assisting in the early detection of antimicrobial resistance resulting in early alerts for Infection Control helping to contain the spread of resistant bacterial strains and allowing for the optimisation of patient treatment. Antibiotic resistance has long been a problem that continues to worsen, and as the incidence of

antimicrobial resistance rises, the range of effective antibiotics continues to decline. It is hugely important that laboratories have access to simple and successful identification methods to ensure efficient sample processing and reliable results. The Mast Uri®System also benefits the patient allowing for a more rapid escalation or de-escalation of therapy in the acute setting, but also allows for swift patient review in the community. For these patients the rapid turnaround of microbiology specimens may be critical in initiating the correct antibiotic at the earliest possible stage, and the provision of a Mast Uri®System in the microbiology laboratory can help in fulfilling these vital criteria. Mast is committed in supporting the clinicians and Biomedical Scientists in the on-going battle against antibiotic resistance and can offer a range of specialised products, including the Mast Uri®System, designed for the reliable detection of resistant organisms.


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Renishaw launch RenDx platform Founded in 1972, The Renishaw Group has grown to become a world leading company in industrial metrology, with over 4,000 employees and a presence in 33 countries globally. Renishaw Diagnostics represents part of the group’s growing focus and expansion into the healthcare sector. Based in Glasgow, the primary focus of Renishaw Diagnostics is the development of the RenDx Multiplex Assay System for diagnosis of infectious disease. Invasive Fungal Disease (IFD) is an emerging global health problem associated with high mortality rates in severely immunocompromised patients. The most common causative agents of this disease are Candida and Aspergillus species, accounting for nearly 90% of all reported IFD. The launch of a new, rapid test for the detection of Candida and Aspergillus DNA extracted from blood samples could make diagnosis quicker and more accurate, reducing the need for anti-fungal therapy for most patients. Renishaw Diagnostics’ first assay, Fungiplex, is a CE-IVD certified test

designed for use on the RenDx Multiplex Assay System, an automation and detection platform that allows processing of up to 45 samples in a single run. The assay identifies 12 Candida and Aspergillus species using a unique detection technology known as surface enhanced resonance Raman spectroscopy (SERRS). The RenDx system uses a unique detection method known as Surface Enhanced Resonance Raman Scattering (SERRS), which is a highly sensitive and specific technique allowing improvements in the level of multiplexing. The assay has two target clinical settings; the ICU and haemato-oncology units. IFDs have been particularly difficult to diagnose and carry an extremely high mortality rate for at-risk populations, so many institutions adopt a prophylaxis approach where at-risk patients are put on anti-fungal therapies without diagnosis, despite the prevalence of fungal disease being very low. However, anti-fungal drugs themselves are toxic and potentially damaging to the kidneys,

and the drugs are extremely expensive. Improvement in diagnosis is required to remove the need for prophylaxis and move towards a targeted approach where only those diagnosed with fungal disease receive antifungal therapy. Progression in fungal diagnostic techniques will hopefully provide clinicians with the confidence in diagnosis that will allow them to move from prophylaxis to a diagnostic driven approach to treatment. Moving forward, Renishaw Diagnostics will focus on demonstrating the assay’s clinical performance in relevant patient populations, and have an upcoming IVD installation at a major hospital in Italy to generate this data. Renishaw Diagnostics hope that the Fungiplex assay will form part of the argument to move from prohylaxis to diagnostic driven approach to fungal treatment.

“The CE-IVD launch of our RenDx platform and first assay marks a significant milestone, not just in the progress made here at Renishaw Diagnostics but more importantly, for infectious disease diagnostics throughout Europe. The extensive target menu for the Fungiplex assay, together with the high sensitivity that can be achieved through our exceptional detection technology, has the potential to aid earlier diagnosis, reduce overall spend and improve patient outcomes for those susceptible to these life threatening infections.” Rupert Jones General Manager Renishaw Diagnostics


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Now in its 14th year, BioWales, the flagship event for the life sciences sector in Wales and one of the leading UK life science conferences, returns to the Wales Millennium Centre on:

1-2 March 2016

The theme of this year’s event – Connect and Collaborate – offers a unique platform in Wales to develop new international connections and partnering opportunities.

Register at


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MEETING THE UNMET Smartphone connected biosensors for medical testing without the laboratory New developments in advanced smartphoneenabled medical device technology allow the fast and effective detection of infectious diseases away from hospital laboratories.

Success in treating many infectious diseases lies in the speed of response; antiviral drugs are most effective within the first three days of the onset of symptoms, so there is considerable benefit in having access to quick and reliable ways to test and monitor patients. There is now a strong international trend to move the testing and monitoring of infectious diseases outside the confines of specialist hospitals by using point-of-care (PoC) devices. At the same time, there is a global increase in use of mobile technology in healthcare. OJ-Bio is at the forefront of this revolution in testing. The Newcastle-based company is a joint venture between the leading nanobiotechnology company, Orla Protein Technologies Ltd, and the wireless communications and electronics specialist, Japan Radio Company (JRC). Through a convergence of technology from its


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parent companies, OJ-Bio has developed a cost effective mobile enabled testing device, allowing quick and reliable results anywhere and anytime. Surface Acoustic Wave (SAW) chips that are normally found in mobile phones and other electronic devices are converted into biosensors by coating them with proteins that give highly specific responses when coming into contact with samples containing disease biomarkers. Vitally, the same high volume mass manufacturing techniques used in electronics can be applied to the biosensor chips, ensuring economic production. No complicated equipment is needed for the analysis; it is purely electronics. When samples such as saliva, urine, or blood, are applied to the disposable biochip, the target biomarker binds to the specific capture proteins on the chip surface. A change in the speed of the surface acoustic wave caused by the binding event is translated into an electronic signal, and then into a test result displayed on a mobile phone app. As no additional equipment, training or complex maintenance is required, testing can be undertaken by professionals as well as individuals. Data and results are immediately available as they can be wirelessly transmitted to a smart phone and secure healthcare systems, enabling

patient records to be updated easily. The output from the biochips is quantitative; it provides the actual amount of the biomarker present rather than simply a yes or no answer, which dramatically increases the utility of the device. The OJ-Bio platform allows the detection of any protein biomarkers, meaning the healthcare application areas for the technology are very broad. The device can be deployed anywhere outside of the laboratory, from professional use in a doctor’s office to personal use in the home. A lead application for the device is the detection of C-reactive protein (CRP). This is a protein biomarker of inflammatory disease, which can be used to rule out serious bacterial infections and which has been proposed as an effective control tool in the reduction of the inappropriate prescribing of antibiotics. As a result of considerable work already undertaken with partners that include Public Health England, Newcastle University, and University College London (UCL), OJ-Bio is already well advanced in developing products for periodontal gum disease, respiratory diseases and HIV. The company is continually seeking new partners to develop new applications and access to markets.

Meeting the unmet

PathXL Ltd: delivering digital precision medicine Digital pathology has been steadily growing over the past 10 years and is now creating enormous global impact in science. As an industry, it has an estimated predicted market value of $437m in 2018. PathXL Ltd is currently the only UK company specialising in digital pathology software, and has been developing novel solutions to support research, diagnosis and education for modern digital pathology since its inception.

Each year, many hundreds of millions of microscopic slides are generated in hospitals, pathology laboratories and in drug and biomarker research organisations across the world. These slides, the tissues they contain, the complex patterns that they show, and the molecular signatures they display, provide the essential information necessary to unlock the mysteries of many diseases including cancer.

The current revolution in the biopharmaceutical industry is underpinned by the need to develop precision or personalised medicines, demanding not only the development of new drugs but also the biomarkers that select which patients will benefit from new therapies. Tissue samples and microscopy are essential for the identification of these biomarkers and will underpin the delivery of precision medicine as a driver to improve patient outcomes. Converting glass slides into digital images using high resolution scanning technology provides all of the benefits of digital media including the automated analysis of cells and tissues to accelerate discovery and improve diagnosis. Digital

PathXL’s TissueMark can analyse and find colon cancer in tissue samples, improving the molecular analysis of cancer and the delivery of precision medicine.

pathology is the digitisation of tissues at microscopic resolution. Whilst high resolution scanning hardware is essential for the digitisation of slides, it is now becoming a commodity with a range of low and high volume scanners on the market from an ever-increasing number of vendors. Of even more importance is the software that enables digital slides to be shared online, to be incorporated within diagnostic and research workflows and to be analysed in new and exciting ways. This is where PathXL has carved out a unique niche in UK, European and international markets. PathXL’s latest software technology, TissueMark™, uses novel computer vision techniques to automatically identify and analyse cancer in digital images. This solution is vital in measuring cancer sample quality, prior to molecular profiling, such as next generation sequencing and other molecular DNA and RNA-based technologies. These molecular signatures have the potential

to revolutionise healthcare in the 21st century, but only if the samples being analysed have sufficient tumour DNA. Without sufficient cancer cells, the chances of finding important mutations are significantly reduced. This could determine whether a patient receives a life-changing drug or not. TissueMark™ uses patented image analysis algorithms to identify cancer patterns in images and measure the numbers of cancer cells. This will ultimately determine whether the sample is good enough for molecular analysis and could potentially reduce inaccurate diagnoses across a range of cancer types. With offices in Northern Ireland in the UK and Baltimore in the USA, and distributors across three continents, PathXL demonstrates how to interface software, biotechnology, diagnostics and biopharma to have a major global impact in cancer discovery and care.


UK Lifescience Industry Magazine

Films fight infection in the workplace Concern about the risks associated with bacterial and microbial infections has led to a high demand for products and systems that minimise the impact and spread of infection in the workplace and public buildings. Coveris Advanced Coatings has responded by developing the reflex™ antimicrobial range of films. reflex™ antimicrobial films are designed to eliminate the growth of harmful organisms such as bacteria, mould and fungi. The product is a lightly textured, scratch resistant polyester film and is ideal for touch panels used in hygienic settings such as healthcare and catering. Coveris Advanced Coatings is a global leader in the development, manufacture and distribution of precision coated papers, films and speciality substrates for digital imaging, electronics, medical and optical technologies. This new product joins a range of high grade graphic overlay films which have been developed to meet the exacting requirements of Screen Printers, Membrane Touch Switch and Fasciapanel manufacturers, and their end users. The technology is particularly useful for touch panels used in hygienic settings such as healthcare and catering, keeping bacteria and mould to a minimum. Devices that use fascia panels and membrane overlays are designed to be used and touched by multiple people, making it even more important to keep the risk of cross contamination as low as possible. The product can be utilised to reduce the spread of infection in healthcare environments such as hospitals. The bacterial barrier performance is achieved by incorporating SteriTouch® antimicrobial into the product. Based on innovative silver technology,


UK Lifescience Industry Magazine

SteriTouch® was developed to reduce the growth of harmful organisms such as bacteria, mould and fungi. The integration process ensures even distribution of the SteriTouch® antimicrobial agent throughout the textured hard-coat and the film surface, providing a reliable, long-lasting bacterial barrier. All of the active components used by SteriTouch® hold EPA and FDA approvals for food contact, as well as being supported for inclusion on the Biocidal Products Regulation, enabling their use throughout Europe. reflex™ antimicrobial is based on a UL listed (flame resistant) polyester film that that is modified by Coveris Advanced Coatings to generate excellent anchorage of the hard-coat to the front side; this creates an ink receptive layer for both UV and solvent based inks, in digital printing and conventional screen printing

processes, making it suitable for a wide range of applications in sanitary conditions. The superior scratch and chemically resistant surface of reflex™ antimicrobial protects against dust, cleaning and damage from many of the chemicals used in a working environment. The product is coated in 1000 Class Clean Rooms, achieving optimum performance in hardness, embossability, chemical resistance, a switch lifetime of more than 3 million flexes, and the ability to be die-cut. Although reflex™ antimicrobial was targeted for the membrane switch market, it can easily be adapted for application to any flat surfaces that might be found in an area where infection needs to be controlled. Potential use for the future could include door push panels, table tops for operating rooms, patient wards or examination rooms.

Natural solutions combat lung infections in people with cystic fibrosis Cystic Fibrosis (CF) is a rare disease occurring in 75,000 people in North America, Europe and Australia. Of these, approximately 11,000 people are from the UK. Like many rare diseases, CF is genetically inherited. It affects multiple systems in the body, including the respiratory, gastrointestinal, genitourinary, endocrine and metabolic systems, and alters the ability of cells in epithelial membranes to maintain an appropriate level of hydration. This contributes to the thickening and accumulation of mucous on these surfaces, creating an ideal environment for bacteria to establish themselves into chronic, medicationresistant biofilm colonies.

Chronic bacterial respiratory infections and their associated inflammatory responses are the most significant cause of death and disability in people with CF. In adults with CF, Pseudomonas aeruginosa (P.aeruginosa) in particular is the biggest single bacterial causal factor of chronic lung infections, occurring in 70-80% of adults with CF globally.

There is currently no cure for cystic fibrosis. Interventions instead aim to manage the symptoms of the disease. Common approaches to management of symptoms include use of antibiotics to eradicate the bacteria causing infection, prescription of mucolytics and respiratory therapy to assist with dislodging and mechanically clearing mucoid secretions, anti-inflammatories to reduce immune response-related inflammation and use of vaccination against certain bacterial infections in an attempt to prevent the infection in the first instance. These conventionally used interventions have

no long-lasting or curative effects, and bring the consequence of resistance of bacteria through extended courses of antibiotics. This situation highlights several areas of unmet need in the medical management of CF as a disease entity, including the need for novel antimicrobial compounds to be developed. Neem Biotech has recently announced its first step in the direction of addressing some of these areas of unmet need. Neem Biotech is a pre-clinical research organisation that works to develop bioactive compounds found in plant and marine sources into platform technologies used to fight against global threats to human and animal health. These threats include antimicrobial resistance, metabolic disease syndrome, immunomodulation and other areas of high unmet medical needs or rare diseases. Particular areas of interest for Neem Biotech include cystic fibrosis, fatty liver disease and wound healing.

successfully registered patents around novel compounds, novel extraction processes for natural compounds and novel applications of existing compounds. They also continue to explore possibilities for developing innovative products derived from natural bioactive compounds in response to customer requests and orders. As the global demand for products based on natural compounds grows, Neem Biotech is uniquely positioned to enable commercial exploitation of natural actives for both applied medical, agricultural and more fundamental research applications.

Neem’s lead compound, that is derived from nature’s diverse library of compounds, works against one of the key processes that allows P.aeruginosa infections to maintain themselves in the lungs of people with CF. The compound is being prepared for a Phase 1 clinical trial in 2016. Over the past 16 years, Neem has


UK Lifescience Industry Magazine

STOP Pressure Ulcer Day Pressure ulcers, usually known as ‘bedsores’ to the general public, are certainly not the most glamorous part of modern healthcare. However, pressure ulcers affect many thousands of people in the UK each year and are a major source of patient morbidity, and in some cases mortality. It has been estimated that around 4% of UK healthcare expenditure may be lost through pressure ulcer treatment with many experts considering that the vast majority of pressure ulcers could have been avoided. In recent years, a new initiative has been launched to help place the misery of pressure ulcers firmly in the mind of health professionals, the public and health care policy makers – the STOP Pressure Ulcer Day.

Thursday November 19th 2015 is this year’s STOP Pressure Ulcer Day. This will be the fourth year that Events relating tohas theworked STOP Pressure Europe to Ulcer Day include lectures on pressure increase the awareness of ulcers, the hosting of small stands within pressure ulcer prevention and treatment. Each year the range and volume of activities has increased, and 2015 promises to be the biggest STOP Pressure Ulcer Day yet.

Events relating to the STOP Pressure Ulcer Day include lectures on pressure ulcers, the hosting of small stands within hospitals and other care locations to share information about pressure ulcers, and engagement in supermarkets and other public locations to spread awareness about pressure ulcers. The organisers have received excellent support from a wide range of sporting personalities who give their time to join the campaign. Over the years of the STOP Pressure Ulcer Day the Welsh Rugby Union have given their support and the annual photo opportunity with the international rugby team is


UK Lifescience Industry Magazine

widely anticipated by the clinical and commercial staff who organise the STOP Pressure Ulcer Day in Wales. Many companies organise activities around the STOP Pressure Ulcer Day, and their engagement takes a range of forms, including a bed supplier from Ireland painting the STOP Pressure Day logo on their fleet of vehicles, bringing the campaign to the attention of everyone who saw the van drive by. Many resources including the campaign logo can be downloaded for free at the European Pressure Ulcer Advisory Panel (EPUAP) website located at www. These include fact sheets about pressure ulcers that are available in black and white and colour formats to help NHS organisations avoid expensive colour photocopying. The Welsh Wound Network website also holds STOP Pressure Ulcer Day resources, as will many other wound care and tissue viability associations and societies.

Welsh Rugby Union full-back Leigh Halfpenny

The STOP Pressure Ulcer Day is now firmly fixed as an annual event with the objective of making as many people as possible aware about pressure ulcers and how to prevent and treat these wounds. The misery of pressure ulcers occasionally comes to the attention of policy makers and the public through media stories after poor care delivery – in Wales the recent publication of the Flynn report upon deaths after pressure ulcer development in nursing and care homes in South Wales makes challenging reading, and really brings home why we must always strive to share information and experiences around pressure ulcer prevention.

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2015-16 Medilink East Midlands: Market Visit Shanghai & Ningbo China 1st November - 6th November 2015


The In Vitro Diagnostic (IVD) Devices Bootcamp (Exporting to the US Market) Manchester UK 2nd November 2015


EBD Group/ BIO: Bio-Europe 2015 Munich, Germany 2nd – 4th November 2015

Life Science Scotland: Antibiotic resistance and antibiotic alternativesLooking towards the future London, UK 3rd November 2015

ABHI: Annual UK Market Conference London, UK 3rd November 2015

2-4 3


The In Vitro Diagnostic (IVD) Devices Bootcamp (Exporting to the US Market) London, UK 3rd November 2015




26 BIA: 12th Annual bioProcessUK Conference 2015 Cambridge, UK 25th – 26th November 2015

BioWales Cardiff, UK 1st – 2nd March 2016


BIO: Asia International Conference Tokyo, Japan 15th – 16th March 2016


BIA: Regulatory Conference London, UK 17th March 2016


CPhl China Pharma Expo Shanghai, China 21st – 23rd June 2016

MediWales & ABHI: Regional Event Cardiff, UK March 2016

EBD Group: UK@BIO-Europe Spring 2016 Stockholm, Sweden 4th – 6th April 2016



22-23 BIA: Global BioLeadership Summit Hatfield Heath, UK 22nd – 23rd June 2016

10th MediWales Innovation Awards Cardiff, UK 8th December 2015

ABHI: Bridging the gap between UDI and eProcurement London, UK 8th December 2015

MediWales: Natural Compounds Special Interest Group Launch Cardiff, UK April 2016


July 21-23



UK HealthTech Cardiff, UK 1st December 2015

Bionow Annual Awards Dinner Cheshire, UK 26th November 2015


6th International Conference on Bioinformatics Philadelphia, USA 22nd – 23rd August 2016

10 One Nucleus: Genesis 2015 London, UK, 10th December 2015

Medtec Europe Stuttgart, Germany 12th – 14th April 2016

12-14 September

August 22-23

17th European Congress on Biotechnology Kraków, Poland 3rd – 6th July 2016



November 25-26

Medilink East Midlands: Meet in the Midlands Staffordshire, UK 5th November 2015

22-24 2nd International Conference on Clinical Trials Philadelphia, USA 22nd – 24th August 2016

14-15 Nordic Life Science Days 2016 Stockholm Waterfront 14th – 15th September 2016

Industry Event Calendar UKTI: Innovate 2015 London, UK 9th – 10th November 2015

Bionow: BioInfect Conference Cheshire, UK 10th November 2015



SEHTA: Diabetes Professional Care Show London, UK 11th – 12th November 2015

Biolatam 2015 Santiago de Chile, Chile 16th – 17th November 2015


EBD Group: JP Morgan Biotech Showcase San Francisco, USA 11– 13th January 2016

Med-Tech Innovation Expo Coventry, UK 20th–21st April 2016


14 Medilink WestMidlands: Medical and Healthcare Bsiness Awards 2015 Birmingham, UK 14th January 2016

Hospitalar 2016 Sao Paulo, Brazil 17th–20th May 2016



International Conference on Biochemistry Kuala Lumpar, Malaysia 13th – 15th October 2016

Mediink East Midlands: Supply Chain Special Interest group (SIG) – Redistributed Manafacturing in Healthcare Network (RIHN) Loughborough, UK 19th November 2015


May 13-15





Medica 2015 Dusseldorf, Germany 16th – 19th November 2015

20 BIA: UK Bioscience Forum London, UK 20th October 2016

20 MediWales & Institute of Electronics and Technology Electronics in Healthcare Wrexham, UK 20th January 2016

BIO: Bio International Convention San Francisco, USA 6th – 9th June 2016

Arab Health Exhibition Dubai, UAE 25th – 28th January 2016

Medilink East Midlands Innovation Day Nottingham, UK 8th June 2016



November 10-12 12th Nanotechnology Products Expo Melbourne, Australia 10th – 12th November 2016

22-23 BIA: BioProcess UK Conference Cambridge, UK 22nd – 23rd November 2016



January 25-28

SEHTA: Unique Device Identification Training Course London, UK 24th November 2015

February 28 BIA: Gala Dinner London, UK 28th January 2016

Informa PLC: Africa Health 2016 Johannesburg, South Africa 8th – 10th June 2016

MediWales & BIA: Regional Event Cardiff, UK February 2016

Medtec UK London, UK 21st – 22nd June 2016


8-10 June


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