Issue 9
United Kingdom
INDUSTRY
Advances in health technology
Recommendations for a new Government Asking how Westminster’s new incumbents can best support the UK life science industry
Pioneering tissue repair technology developed in the UK BioHub Birmingham provides biomedical innovation launchpad 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: EXPLORING THE CONVERGENCE OF CONSUMER AND PROFESSIONAL MEDICAL DEVICES
delivered by
Life Science Industry Conference 1st December 2015, Cardiff, Wales One Conference - Two Essential Streams
• Pharmaceutical Development
• Medical Technology
For more information visit www.ukhealthtech.com or contact tess.coughlan-allen@mediwales.com, +44 (0) 29 2047 3456
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INDUSTRY
4-5
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Ten recommendations for a new Government
A message from the editor
This edition
Looking ahead With a world-leading science base, UK life science forms the basis of an industry which is of great strategic importance to the future economy and is rightly prioritised through the UK’s 10 year Life Science Strategy.
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The convergence of consumer and professional medical devices 2012 ISSUE 4
5 Given the forthcoming elections Issue it seemed timely to draw on responses from leading life science sector representative bodies and to then compile their key Issue 5 recommendations specifying how a new Government can continue to support the UK sector in matters Issue 5 relating to life science. These recommendations are outlined on pages 4-5.
2012 ISSUE 4
2012 ISSUE 4
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Scottish Life Sciences’ award winners
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Medilink UK Awards nominations
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Funding to unleash your innovation
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Lucinda Scott-Morgan Editor
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© MediWales 2015 Advertising: CharlotteLtd. Tyson
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Enhancement
20 Charging ahead with medical devices 21 Vernacare introduces a new commode chair that is cleaner by design 22 NICE publishes Medtech innovation briefing on ZedScan 23 Willgo Wheelchairs... enhancing mobility 24 Time for Medicine’s cloud-based platform for patients
Future watch
26 Printing spare parts for spines 27 Glyconics’ licence to breathe 28 Fighting disease with technology 29 Medilink supports pioneering tissue repair technology 30 New non-invasive system aims to reduce the incidence of diabetic KetaAcidosis 31 N4Pharma... one to watch 32 £2m funds ground-breaking technology to detect cancer during surgery
Going global
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How a new Government can support the UK life science industry
34 Co-Formulate working with Medilink EM 34 GBUK Ltd leads international push for new enteral ISO standard 35 HALO enhances cell data reporting 36 Nottingham’s Scandinavian initiative
Made in the UK
38 The BioHub Birmingham® set to be the region’s ‘Biomedical innovation launchpad’ 39 Welsh design engineering from GX destined to prevent global water contamination 40 Implanting dental solutions in the UK 41 Synergy’s speedy solution for roadside drug
testing
Meeting the unmet
42 Advances in the diagnosis and management of suspected pre-eclampsia 43 Diabetics giving amputations the boot 44 Bioscience crowdfunding platform launches for new and rare disease research www.medilinkuk.com www.medilinkuk.com PUBLISHED FOR
www.medilinkuk.com
View an interactive version of this edition at www.medilinkuk.com
Ten recommendations for a new Government UK life science requires long-term vision from Government for building an infrastructure and developing an ecosystem where scientific innovation can flourish cannot be achieved over the life of a single parliament. Drawing on responses from leading life science sector representative bodies we have compiled their key recommendations for a new Government to continue to support the UK sector. The UK has a proven track record in life science, with one-eighth of the world’s most popular prescription medicines being developed here and a medtech industry worth some £17 billion. With this world-leading science base, UK life science forms the basis of an industry of great strategic importance to the future economy. UK life science companies continue to tackle longterm health challenges such as cancer and antimicrobial resistance, and in addition to this many companies are using bioscience to address a range of issues including environmental challenges and chemical production. The UK also has the most highly regarded universal healthcare system in the world, the NHS. The NHS, in turn, is highly dependent on technology produced by the industry to enhance the efficiency of services and to drive continuous improvement in their delivery. Life science can transform health, create jobs and grow the economy. The sector is rightly a national priority for the UK, employing an estimated 183,000 people across the UK, with 72% employed in companies producing products for the health care market and 28% in the service and supply chain. It is comprised of an estimated 4,398 companies and their sites developing, manufacturing and marketing products and services to the UK and global markets and generates a combined estimated turnover of £56bn.
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UK Lifescience Industry Magazine
Ten common themes and recommendations from sector representatives are addressed below: 1
A supportive finance and tax environment should be maintained and further enhanced for research-intensive companies. The R&D tax credits and Patent Box to be both maintained and remain globally competitive. The potential of tax-advantaged investment schemes should be maximised ensuring better alignment with areas of future growth and innovation.
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A single approval system for all health research studies should be delivered in England as approved in March 2014 by the Department of Health. The Health Research Authority (HRA)’s plan is to work with the Medicines and Healthcare products Regulatory Agency (MHRA).
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3. A unified vision outlining the supporting infrastructure, skills and investment required to ensure that the UK medicines and medical technology manufacturing sectors remain competitive. Regulation is key as UK regulators need to stay up to speed with developments in manufacturing technologies.
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A separate evaluation framework for orphan medicines for very rare diseases should be established as unique characteristics and challenges are involved with evaluating medicines for these conditions. Health technology assessment processes need to be evaluated in order to ensure that patients can have full access to cutting edge treatments.
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The UK bioscience ecosystem is built on our world-class academic science base and it is important that the interconnected nature of the ecosystem is recognised and that the UK continues to fund this excellent academic community to maintain its global leadership.
The UK Life Science Industry
183,000 people employed
56
£
bn
Combined Turnover
Ten recommendations for a new government
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The UK needs to improve the current ‘tech transfer’ operational model to ensure that intellectual property generated in academia is commercialised to its fullest potential and implementation of the Unified Patent Court closely monitored to ensure it delivers a cost effective, reliable and predictable regime for the enforcement of patents If there were an in/out referendum on UK membership of the European Union, a plan of the expected disruption to UK life science businesses should be made available. In particular this should include the handling of
the European Medicines Agency and Unified Patent Court leaving London, how products would be approved and regulated, and the likely impact on investment. 8
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Through engagement with the European Medicines Agency, the EU clinical trials portal and database to be developed and fully functional by mid- 2016. The NHS faces ever-increasing demands at a time when the country needs to contain public spending. The imperative for the NHS to do more for less is well recognised and medical technology is part of the solution. Therefore, it is important for
the Government to widen patient access to the latest technologies and treatments, create efficiency savings for the NHS and grow the industry to generate wealth for our country. 10
In relation to SMEs more support is needed for innovative R&D projects and an increase in the tax breaks for R&D should be given. SMEs ought to have easier access to the NHS procurement systems and there should be greater support for SME and university or NHS collaborations, which are vital for the sector.
Sources: ABHI’s Manifesto for Medical Technology-2015. ULS-UK Life Sciences Manifesto 2015-20. HM Government-Strength and Opportunity 2014
The Life Sciences Revolution Historians debate the extent to which the British public was aware that it was starting an Industrial Revolution in the late 18th Century. Certainly no-one could fail to notice the new towns and economic disruption of the time, but the full extent of that transformation was only apparent with hindsight. It may be the same for future generations looking back at the UK’s current Life Sciences Revolution, where giant leaps in genomics, oncology and med tech are being made on a regular basis. But for the revolution’s next phase we need the vaunting ambitions of those early industrialists.
We need the Government, the media and the public to champion the sector as a true British success story. This means adopting a tax structure that encourages investment and takes into account its unique risks and challenges. British innovations need to be commercialised here. We must maximise the use of our best research asset – the NHS and its vast data. We need to be arguing for sound science policy in Brussels. We need cities and regional governments
to put life sciences at the core of their economic strategies, as London and Wales have done. Our universities and research hospitals are key assets, as are our worldleading charity researchers such as the Institute of Cancer Research, and we need to find new modes of collaboration between these public, private and third-sector facilities. Infrastructure will be important – not only the wet labs and incubator spaces, but also the academic
facilities, skills base and transport links that make London a world capital of science and business. Scientists and investors are leading this revolution. Those of us in the public sector must do what we do best – help clear the blockages, jump on the bandwagon and make the arguments in favour of a sector that is surely becoming the British success story of the 21st century.
Joe Mitton is the Special Adviser for Business and Science at the Mayor of London’s Office.
UK Lifescience Industry Magazine
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United Life Sciences
United Life Sciences (ULS) is a strategic partnership representing over 1,100 life science and healthcare organisations across the UK and internationally. Four founding partners formed the partnership: BioIndustry Association (BIA), Bionow, BioPartner UK and One Nucleus in 2014. MediWales joined the partnership in March 2015. The ULS collaboration has both member and the wider UK life science sector benefits at the heart of its purpose and these are the basis for all joint activities. The collaboration strives to avoid duplication of effort and coordinates the founders’ activities whilst recognising each other’s areas of strength so that member companies can benefit from more effective and coherent sector support. Between 2012 and 2014, ULS worked informally together on a range of activities – including the creation and publication of a UK Life Science Manifesto 2015 – 2020, which is, aimed at all political parties. This Manifesto sets out what the collaboration and its
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members believe is required for the future health and wealth of the UK during the next parliament. Crucially, ULS hosted a series of UK-wide roadshows polling its members on their own key issues, which led to the production of this Manifesto in which policy recommendations are made to Government. ULS has already hosted a number of joint events both in the UK and overseas and going forward will be undertaking further joint initiatives as well as providing cost effective attendance at each other’s events to maximise the international impact of the UK. Over the coming months it is anticipated that the representatives on ULS will grow to further enhance the benefits to life science companies and UK plc.
www.bioindustry.org/document-library/uk-life-sciences-manifesto-2015-20/ UK Lifescience Industry Magazine
New Appointments
Association of British Healthcare Industries Earlier this year Johnny Lundgren informed ABHI Secretariat, and the Board, of his retirement from Becton Dickinson and consequently that he would be stepping down from his role as Chair of the ABHI Board. Over the past four years Johnny has been instrumental in positioning ABHI as the pre-eminent representative body of the medical technology industry. His leadership, at a time of significant change in the NHS, has been pivotal in ensuring ABHI is a valued interlocutor, and our industry as a key solutions provider, in the minds of our critical stakeholders.
wise council and leadership of the Board over the last four years. Continuing to build on the impressive work that Johnny and the entire team at ABHI have achieved during this period will be my key priority as incoming Chair.' ABHI is also pleased to announce the appointment of two vice-chairs to support Phil Kennedy, and Secretariat in leading the execution of the Association’s strategy and priorities. ABHI Vice Chairs are Jackie Fielding, Regional Vice-President, Medtronic UK & Ireland, and Shah Fayaz, Chief Executive, Timesco.
Jackie Fielding
Philip Kennedy With Johnny Lundgren stepping-down, it has been ABHI’s priority to ensure a smooth transition to a new Chair. To that end, we are delighted to announce that Philip Kennedy, Vice President Global Marketing of STERIS Surgical Solutions and Managing Director of Eschmann Equipment has been elected by the ABHI Board as Chair. This is effective as of 26th March 2015. Phil is a vocal and passionate supporter of both the British manufacturing sector and the adoption of new technologies within the healthcare market. On being elected, Phil Kennedy says, 'It is a great honour to be elected as Chair of the Association and I would like to add my personal thanks to Johnny for his
Shah Fayaz
These appointments recognise that the relationships and networks ABHI has built in recent times is leading to many more opportunities for the Association to get involved in and lead programmes of work. Jackie will offer her leadership on critical work areas to do with the UK agenda - addressing issues such as innovation adoption and NHS engagement. Shah will lend his support to ABHI’s activity on the international agenda as we look to ensure government places greater emphasis on actions that will improve international trade opportunities for British medtech businesses - and boosting growth of small/medium-sized organisations. ABHI would like to take this opportunity to thank Johnny Lundgren for his support and guidance. It has been our pleasure to work with him and we congratulate him on his retirement. We look forward to working with not only Phil, but also Jackie and Shah, to build on Johnny's legacy to ensure the Association continues to go from strength to strength.
UK Lifescience Industry Magazine
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Exploring the convergence of consumer and professional medical devices The last few years have seen considerable efforts by consumer electronics companies to enter the wearable and portable medical technology sector, including the launch of development platforms such as Apple’s HealthKit and Samsung’s S Health. Many experts are concerned about the result of mixing commercial short-termism with traditional longterm medical device development and are exploring the use of portable medical devices in home healthcare against a patient’s expectations. Think of medical technology and you may think of a large, AC mainspowered machine like a ventilator, anaesthesia machine or medical imaging equipment such as an MRI,
PET or CT scanner. However, the reality is that you are probably carrying one in your pocket as a typical smartphone now carries the computing power which was historically limited to process intensive industries such as space exploration missions. According to Neil Oliver, Technical Marketing Manager at Accutronics, it is this ambiguity, which is blurring the line between a consumer electronic device, such as a smartphone or smartwatch, and a fully-fledged professional medical device. Designed for portable use to monitor, diagnose and inform long term treatment plans, the functions performed by professional medical devices, such as pulse oximetry, blood pressure monitoring, kidney diagnosis and
glucose meters, have opened the market to consumer manufacturers and third-party app developers, sometimes putting patient health at risk.
The innovation in portable and wearable devices has largely been the result of an ageing population all over the world. This has led to a rise in age-related, long-term health conditions and it is no surprise that this trend is proving challenging for an already over burdened hospital and inpatient infrastructure.
However, the medical devices designed for use in hospitals by trained professionals were never intended for use by patients in the home. As a result, many patients, especially those who do not have the regular assistance of a dedicated home healthcare professional, struggle to operate and understand, these devices. This has spurred third-party manufacturers to cater for patients looking to fill the void with pseudo-medical devices featuring familiar ergonomics and heuristics.
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Consumer Medical Devices
An eight-month trial in 2013-14 of “low intensity telehealth” was carried out among 92 residents of nursing and care homes in Sussex. They had typical ailments of old age: congestive heart failure, diabetes, serious breathing problems and urinary tract infections. The local NHS community care trust gave the homes involved Android tablet computers fitted with an app devised by Docobo, a digital health company. This app enabled staff to ask the patients questions regularly about how they were feeling, with the information then analysed remotely by four “admission avoidance matrons”. Anything untoward about a patient’s readings triggered an alert.
The yellow card system used by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) is used in the medical industry to allow patients to report the adverse effects of medicines and incidents occurring from the use of medical devices. Raising awareness of methods like these will ensure that the right feedback is given to manufacturers to improve their products, undergoing any clinical testing where necessary. As companies like Samsung and Apple enter into the wearable medical space, a concerted effort by all stakeholders will ensure that commercial short-termism can be turned into sustainable long term improvements in our health and, more importantly, in our quality of life.
Prof Bruce Keogh: wearable technology plays a crucial part in NHS future Prof Sir Bruce Keogh, NHS England’s medical director, believes wearable technology, like Apple’s Watch, and others resembling games consoles could revolutionise the NHS and future healthcare by monitoring patients’ health.
Wearable technology could easily prove useful for people with heart failure – one of the most common causes of admission to hospital – and thus relieve the strain on overcrowded hospitals.
During the trial, the matrons received 252 alerts as a result of heart failure, 181 for breathing problems, 36 for a UTI and 20 for diabetes. Previously, most patients whose health deteriorated ended up in hospital however the early drop in hospital warning system, which cost admissions following low intensity just 90p a day per patient, led telehealth to a 75% drop in those who had to be admitted. Staff were able to intervene earlier and, for example, change their drug regime to stabilise their health.
75%
He states that technology “enables you to predict things, to act early and to prevent unnecessary admissions, thereby not only taking a load off the NHS but, more importantly, actually keeping somebody safe and feeling good.”
Keogh says in the future “people will use more wearable technology. People with conditions such as diabetes, heart failure, liver disease or asthma will wear devices, skin sensors or clothes capable of detecting deterioration and bringing this to the attention of the patient or anyone else they choose, through mobile phones. This monitoring will help keep people safe in their own homes rather than just waiting for serious deterioration necessitating an ambulance or GP call, followed by admission to hospital for several days.”
The NHS is targeting new health technology on those who already have health issues. NHS Choices already has a page on health and fitness trackers (http://www.nhs.uk/conditions/nhshealth-check/pages/tools-and-technologythat-can-help.aspx) which suggests free downloadable apps to help those who want to quit smoking or lose weight. The National Information Board has set up a taskforce to review and then kite-mark health apps of all kinds, which by the end of the year – it is hoped – will be listed in the NHS Choices apps library. Some of those apps will collect data, which will then enable NHS doctors to learn more about a patient’s health without calling him or her in for an appointment.
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Celebrating Scotland’s life sciences winners Held at the Edinburgh International Conference Centre on Thursday 5th February, the prestigious Scottish Enterprise Life Sciences Awards ceremony was attended by over 800 guests from the global life sciences community. The awards recognise the success and achievements of Scotland’s internationally renowned life sciences sector in areas including innovation, investment, community engagement and collaboration. They also focus on the ongoing work of Scottish Enterprise and its partners to grow and develop a sustainable, globally competitive life sciences sector in Scotland. Scotland’s life sciences industry already contributes more than £3 billion a year to the Scottish economy with some 650 organisations employing around 35,000 people. It is globally recognised for its high levels of innovation – translating ideas and research into novel treatments and world-leading therapies.
Julia Brown, senior director of life and chemical sciences at Scottish Enterprise said,
“Congratulations to this year’s winners. Once again the quality of the candidates was outstanding and reinforced the strength of the skills pool that makes up the Scottish life sciences industry. “The theme for this year’s awards was connectivity: from connecting with new markets and other sectors, to exploring potential collaborations. As an industry, it is vital that we work together to realise new opportunities in order to drive home long term, sustainable growth for the Scottish economy.”
The winners of this year’s awards are: Life Sciences Business Leadership (2014) Eleanor McFadden, Frontier Science (Scotland) Ltd. Life Sciences Entrepreneurial Business Leadership (2014) Professor Andrew Hopkins, ex scientia Ltd Investment of the Year (2014) NuCana BioMed Ltd, Edinburgh Innovation Award Tactical Wireless Ltd., Forres Innovative Collaboration University of Glasgow with NHS Greater Glasgow & Clyde, Aridhia and Thermo Fisher Scientific Ltd., University of Glasgow Community Engagement BASF Pharma (Callanish) Ltd, Isle of Lewis Export & International Trade ProStrakan Group plc, Galashiels
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From knee replacements to nanomedicine, UK Lifescience Industry covers the complete health technology spectrum. ● In-depth features explore sector-wide concerns ● Sector experts contribute specialist columns ● Case studies describe the challenges of innovation ● Digests cover news and developments throughout the UK
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Shortlist announced for worldleading healthcare awards MEDILINK UK AWARDS 2015 Companies from across the UK have been announced as part of the shortlist for the prestigious Medilink UK Awards 2015 - celebrating cutting edge technologies, outstanding business achievements and international success across the UK’s Life Sciences sector. The Medilink UK Awards, a nationwide competition spanning over 1,500 Life Sciences companies will celebrate its winners at a Gala Dinner in April, alongside the UK’s largest Medical Device industry event the Med-Tech Innovation Expo 2015. This esteemed awards ceremony, will take place on 29 April in the E.ON Lounge at the Ricoh Arena, Coventry. Companies have been shortlisted by judges in every region of the UK. The entries are made up from the best of the regional Medilink Award winners and categories for this year’s awards include: Start-Up, Innovation, Partnership with the NHS, Export Achievement and Outstanding Achievement.
Shortlisted companies: Shortlisted for the Start-Up Award celebrating new businesses with a promising future are: CYP Design Limited Medilink East Midlands Jellagen Pty Limited MediWales Perfectus Biomed Medilink North West The Diabetic Boot Company Limited South East Health Technologies Alliance (SEHTA) Aston EyeTech Limited Medilink West Midlands Swellaway Limited Medilink Yorkshire & Humber Taragenyx Life Sciences Scotland The Innovation Award is given to companies who have pioneered certain areas of healthcare and developed ground-breaking products to solve life threatening problems. Shortlisted for this award are: Snowden Healthcare Medilink East Midlands Tactical Wireless Life Sciences Scotland Asalus MediWales Global Diagnostics Medilink North West The Learning Clinic SEHTA Kimal PLC Medilink West Midlands Brandon Medical Medilink Yorkshire & Humber Shortlisted for the Partnership with the NHS Award are companies that have developed collaborations with the NHS that will have a major impact on business performance or patient care. The shortlisted companies for this category are: B&V Group Medilink East Midlands Microvisk MediWales Veraz Medilink North West Dolby Vivisol SEHTA Genesis Automation Limited Medilink West Midlands V-Connect Medilink Yorkshire & Humber
Examples of excellence include; West Midlands-based Genesis Automation Ltd who, in a collaboration with the NHS and some of its major suppliers, created Genesis an Inventory and Cost Management System that is able to provide hospitals with instant data on costs for all procedures in real-time, enabling the hospital to produce better patient outcomes and control costs more efficiently.
Awarded to the company recognised for an outstanding performance trading overseas, the Export Achievement Award includes shortlisted companies from across the country. The shortlisted companies are:
West Yorkshire-based V-Connect also stands out for the service they developed which offers a secure, simple way for care organisations to interact with people at home using video communication as does Cardiff-based Alesi, formerly Asalus, which has developed Ultravision- a system which handles the surgical smoke produced during laparoscopic surgery.
The Outstanding Achievement Award is presented to companies whose achievements have had a significant or vital impact on the company and the sector as a whole. The shortlisted companies for this category are:
Advancis Medical Medilink East Midlands DTR Medical MediWales Vernacare Medilink North West Deltex Medical SEHTA Nutra Health Group (Natural Wellbeing Ltd) Medilink West Midlands Principle Healthcare Medilink Yorkshire & Humber
International Laboratory Services Limited Medilink East Midlands Sharp Clinical Services MediWales Mast Group Limited Medilink North West Novarix Limited SEHTA Physiological Measurements Limited Medilink West Midlands GBUK Limited Medilink Yorkshire & Humber
Sponsors:
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A restructured KTN for support of cross-sector innovation technologies, and strive to stimulate new, exciting innovations at the interfaces between them. As a new organisation with extensive reach into industry and the influencers of innovation in the UK, we are very well placed to address the priorities facing us in specific sectors and how collectively we can address these through better collaboration, coordination and delivery. Dr Terry O’Neill Head of Health, Knowledge Transfer Network The Knowledge Transfer Network as a single entity was one year old on 1st April 2015. The new organisation has brought together the majority of the previous KTNs and now has a strong vision to capture maximum value from the UK’s science and creativity to grow the economy and improve people’s lives. We are now better equipped than ever before to work across sectors and
That said, the core expertise in the health team and our subsequent priority areas fit into the following fields: ● Clinical Needs ● High Value Manufacturing ● Digital Health & Data ● Stratified Medicine (including
Anti-Microbial Resistance) ● Emerging Medical
Technologies I came into the organization as Head of Health on July 1st 2014 and have been developing a strategy for the team that not only maximises our industry support activities and builds on our geographical locations but also develops our cross-sector technology reach. For example, our work with the Stratified Medicine Innovation Platform has benefited from the KTN’s activity in health, medical biotechnology, electronics, photonics, sensors, built environment and independent living.
● Regenerative Medicine ● Independent Living
These priority areas mirror those of our funders, Innovate UK, but also respond to UK industrial priorities. I believe that the KTN Health Team is an important part of a wide ranging organisation that can draw expertise from across industry sectors and technology specialisms to support innovation in health and life sciences. The extent of the KTN’s reach can be seen in the graphic below. The graphic highlights that the KTN essentially acts as a link between industry on the left hand side, via Innovate UK support structures and funding vehicles, to the wider stakeholders on the right hand side. As the UK’s innovation network the KTN has the bandwidth to bring together businesses, entrepreneurs, academics and funders to develop new products, processes and services. Initially though it’s always better to discuss what it is that the KTN can do for you so please feel free to contact me should you wish to know more. My contact details are listed below.
E mail: terry.oneill@ktn-uk.org Mobile: 07972 848109 UK Lifescience Industry Magazine
Essential Testing Diagnostics are an essential component of healthcare. The Department of Health estimates that diagnostics contribute about 70% of the information on a patient’s record. In vitro diagnostics (IVDs) are the tests performed on a patient sample, most commonly blood, but can be done from any body fluid or tissue. IVDs are used to help diagnose disease, but they also add value elsewhere; for example ensuring the safety of blood supply by determining blood type and screening for infectious agents, monitoring therapy, as a tool for managing chronic disease and screening the population (or at-risk sectors) for disease.
personalising and targeting medicine, ensuring the right patient receives the right drug at the right time. An example of a drug dependent on the use of a diagnostic test is Herceptin. This is used to treat some breast cancer patients after they have tested positive for their tumours secreting the HER2 protein. If this protein is not detected then the drug will not be effective in that patient. Crucially, this will bring additional safety by minimising adverse reactions to drugs and, of course, saves money by preventing the prescription and use of drugs where they will not work.
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Many of the most essential tests, traditionally performed in a central laboratory, can now be carried out in the hospital, or at the patient’s bedside using point of care testing (POCT). The IVD industry has developed the technology to allow reliable, simple to perform and accurate tests to provide information with minimal delay in a critical setting such as in A&E or Intensive Care.
The award-winning Emergency Multidisciplinary Unit (EMU) in Abingdon, led by Dr Dan Lasserson is a case in point. The EMU focuses on older and frailer patients in the community, who are referred by their own GP, a community nurse or ambulance paramedic. The EMU hosts a point of care blood testing service with rapid results as well as X-ray facilities, together facilitating rapid diagnoses. Patients receive the care that they need, with reduced admission rates and patients can go home the same day - although, beds are available in the EMU if required. In the Financial Year 2011/12, the Abingdon EMU saved the NHS ÂŁ1.9 million.
Adoption of these diagnostic innovations is vital for efficient and effective healthcare for the patient, and reforms are needed within NHS procurement and healthcare budgets to allow hospitals to adopt these tests. One of the biggest issues for industry now is how to get the products into the NHS, as there is often a feeling that products can get to the top of the hill but not quite over the brow. BIVDA, as the representative voice for the IVD industry continues to raise awareness of these issues, and our team would be happy to clarify further any queries that you may have. We work with all partners to support IVD companies and the life sciences industry and we are delighted to join as a partner in this UK Lifescience Magazine.
Harnessing the potential of diagnostics is being increasingly prioritised by the NHS and Government as IVDs are key to
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www.bivda.co.uk
UK Lifescience Industry Magazine
Regulations
Surviving regulatory inspections Medilink West Midlands member, Three Circles is experienced in helping clients prepare for successful inspections from both the EU and US, Three Circles has some advice on how to survive when it comes to regulatory inspections. Common areas of concern for the agencies included;
Correct these 9 deficiencies to avoid becoming regulatory inspection road-kill. The top observations found during inspections of both pharmaceutical and medical device manufacturers are reported each year by the US regulatory agency, the FDA, as separate datasets in both the media and trade press. However, it can be very useful to see what is happening on the other side of the fence and specially so for those developing a combination product, as these devices must comply with the requirements of both the Quality System Regulation and Good Manufacturing Practice. The picture in Europe is less easy to determine, as inspection trends are not routinely published. That aside, the most recent data published by the MHRA indicates comparable themes to those experienced by the FDA and shows the similarities across both drug and device inspection deficiencies.
Lack of SOPs (Standard Operating Procedures) in key areas (e.g. CAPA (Corrective and Preventive Actions), change, especially for design changes)
Lack of evidence of following SOPs that are in place, across many areas of operation
Inadequacy of testing for release of batches of drug product and devices
Poor or non-existent, calibration and maintenance of laboratory and production equipment
Process validation gaps or absence
Investigation of failures being inadequate
Either a lack of, or undocumented training
Incomplete records for batches produced, be they drug product or medical device
Changes, whether they are to design, continuous improvement or as a result of CAPA, are often poorly proceduralised and documented.
There are five things to focus on to get it right, irrespective of whether a manufacturer is working on a medical device, combination product or drug product: Document what you do – compared with the regulations “say what you do” Ensure that you have routinely got evidence of following your procedures “do what you say you’ll do” Make sure that your incoming, IPC and release tests are appropriate to demonstrate you are meeting your specifications, and that there is continual documentation of results etc. “make sure what you are doing makes sense” Be able to demonstrate, robustly, that your processes are validated and maintained in compliance with their validated scope of use “keep doing what you say you’ll do” Use a change management process that helps you keep on top of changes, their impacts and ensures you document all that you need to demonstrate robust investigation and resolutions, no more, no less “document when you need to change from what you said you will do, and justify it”
Another point to focus on is that there is increasingly greater scrutiny of purchasing controls by regulatory authorities. Manufacturers need to be prepared and to take an honest look at their controls for sub-contracting and outsourcing of activities or supply.
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The key to all of this is understanding what is really needed and how to go about it. It is a fine balancing act between over-documentation and failing to describe what you do sufficiently to enable your people to follow it routinely. Taking time to
prepare by talking to a specialist can pay huge dividends and avoid you tying yourself in knots.
www.threecircles.eu
Collaboration
Collaboration works Collaboration has been the key behind many UK SME success stories. Understanding the importance of this business strategy the British Standards Institution (BSI) launched their Collaboration Standard - BS 11000. The standard provides a framework for managing all types of collaborative business relationships, which organisations of all sizes and types can benefit from using. The standard helps develop and manage stronger connections, puts in place the right processes and behaviours necessary to foster trust and create value. For small businesses, this helps ensure that the competencies and expectations of partners are aligned. Since the launch of the BS 11000-1: 2010 Standard, Medilink North West member Flintloque Management Systems Ltd, collaborating with P&Q Consulting Ltd developed a series of collaborative training sessions and implementation tools focusing upon
‘The Five Pillars of Collaboration’ ™ which provide basic foundations for a collaborative business relationship. Each of ‘The Five Pillars of Collaboration’ focuses on one of the major themes within the BS 11000-1: 2010 Standard. Combined they provide a framework to establish the correct systems and behaviours to facilitate a successful collaboration. In simplified form, the framework is built like this: Pillar 1: Collaboration Strategy – deciding if a collaborative solution is the right one Pillar 2: Assess and Select – determining your strengths and choosing a complementary partner Pillar 3: Develop the Deal – establishing a joint management team and building trust Pillar 4: Deliver the Value – delivering on measureable targets to demonstrate effectiveness Pillar 5: Governance and Behaviours – encouraging beneficial collaborative behaviours ‘The Five Pillars of Collaboration’ has been designed to help organisations plan, implement and manage one or more collaborative relationships and give a formalised structure to the often fluid world of collaboration. The results of the BSI funded case study have been highly positive. Medilink North West member GBDbio, a biotechnology company whose approach
to forming partnerships lacked framework, received help on structure and formalisation of collaborations.
The BS 11000 template is a helpful resource for defining the commercial agreements and project plans.”
John Manwell, GBD’s Chief Operating Officer, said in the study, “GBD is developing global partnerships which are critical to our business plan.
“BS 11000 has provided a comprehensive checklist to go through when entering into collaborative partnerships, which provides
reassurance to all the parties involved that the right approach is being taken to build successful and sustainable collaborations.”
www.flintloque.co.uk www.pandqconsulting.co.uk
UK Lifescience Industry Magazine
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Funding to unleash your innovation Pressure on the UK’s healthcare service has opened the way for innovators in consumer healthcare, medical technology and diagnostics. However, securing the necessary finances to bring products to market is still a challenge.
A significant proportion of innovative healthcare and medical device ideas come from small and medium enterprises (SME) but left to cope on constrained budgets, these ideas can be slower to develop and often later into the marketplace. They may never complete at all.
Contrary to popular opinion, there is no shortage of funding but a shortage of quality, well-constructed applications, and confusion over what is available. Just a few minutes of online research into the big lenders and grant-awarding bodies will show that most are interested in market-changers and disruptive, scalable technologies. However, to navigate through the funding landscape and avoid the application pitfalls, it is often helpful to seek advice and learn from the experience of other companies. Matt Symonds of, Medilink East Midlands member, TBAT Innovation describes two funding schemes commonly used to unleash innovative new ideas.
A cash injection Government support for innovation can take many forms, but one of the most helpful, according to business owners, is being able to reclaim research and development spend as a tax refund or credit.
Derbyshire-based Medstrom submitted a claim for an R&D Tax Credit following the successful completion of a number of innovative R&D projects. The company designs and manufactures bespoke healthcare equipment used in NHS hospitals to assist with moving and handling, skin management, infection control, patient falls and asset tracking. When the company approached TBAT with
a new project, it was evident that previous project costs such as salaries and materials would make them eligible for an R&D Tax Credit, going back three financial years. Preparing the credit report and submitting the financial claim to HMRC was relatively straightforward. David Belli, Director of Medstrom commented that ‘TBAT quickly identified qualifying R&D spend in order to maximise our claim, releasing vital funding for future R&D’.
The Medstrom Dolphin Bed
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BIOTECHNICA The Smart approach Innovate UK is in effect an arm of government which releases numerous grant funding schemes throughout the year. For innovative small and medium enterprises (SME) employing 1-249 people this is the ‘always open’ Smart scheme, and specifically the Biomedical Catalyst for the health and medical industry. Funding is available to companies from new start-ups through to large multinationals, with the majority spend on R&D to cover project outlays on labour, overheads, materials and subcontractors. As one of the largest distributors of catheters in the UK, Kimal plc identified the need for a fast and reliable way to detect sepsis, a major cause of morbidity and mortality due to delayed administration of medication. Knowledge of the industry and access to market feedback prompted Kimal to develop a novel platform/catheter capable of detecting the symptoms of sepsis early without the need for drawing blood or analysis. Kimal approached TBAT Innovation through Medilink West Midlands, for assistance in applying for a TSB Smart Grant. With TBAT support, the company was awarded a £100,000 Smart Grant towards the cost of the technical
Three days. More than 600 exhibitors from 28 countries. A clear vision. A complete overview of the value chain across the whole biotech industry. Access to new contacts. International networking and partnering services. Staying up to date. Information and insights into Bioeconomy, Personalized Medicine Technologies and BioIT.
6 – 8 October 2015 Hannover ▪ Germany biotechnica.de
Kimal: Winners of the 2014 Medilink West Midlands Award for Innovation; shortlisted for the 2015 Medilink UK Awards
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expertise needed to bring a commercially viable solution to market ahead of any potential competition. Grant funding assessors look for two things when reading an application; one is a high level of innovation which is bringing something better, faster, smaller, cheaper to the market and secondly a high level of technical risk for the company. Kimal was able to demonstrate both these requirements in their submission. Typically, a consultant can help to scope out an appropriate project, write the grant funding application and its associated forms and then submit all documents to the awarding body for review. TBAT Innovation has over 12 years of accessing grant funding for clients across a range of schemes and industries, and last year raised over £20 million in grant funding for promising client projects. If we want Britain to innovate its way out of recession and into economic growth, we must make the most of the grant and tax incentives on offer.
www.tbat.co.uk
Sector Marketing ▪ Tel. +44 12 75 33 5 91 1 info@hfgreatbritain.com
ENHANCEMENT Charging ahead with medical devices Based in Newcastle and a member of Medilink West Midlands, independent battery design, development and manufacturing expert Accutronics, has launched a new smart battery which fulfils the needs of manufacturers of high powered medical devices. The CMX series packs a punch - offering high energy density along with high power discharge. Medical OEMs (Original Equipment Manufacturers) are now able to produce innovative portable devices without compromising on safety and reliability in life-critical applications. The medical market is a challenging environment, and understandably so for with people’s lives on the line it is essential that medical practitioners can rely on their equipment to perform under pressure. The rise in the use of portable devices such as acute ventilators, anaesthesia workstations and intra-oral scanners over the last twelve months has left many medical OEMs struggling to keep pace in the market. The battery is available in three versions, using eight, twelve or sixteen ‘18650’ sized cells, with continuous discharge rates of up to 300W. Two voltage platforms are used; 28.8V, which operates between 20.0V and 33.6V and 14.4V, which operates between 10.0V and 16.8V. Smart features of the CMX series include active and passive protection circuits that prevent over-temperature, over and under-voltage, overload and short circuit.
Forming an essential part of its medical device operation, smart power management means the battery only requests charge when needed and shuts down when not being used. Accurate fuel gauging is possible to 1% through an LCD display, further enhancing reliability. The new battery complies with the relevant transport regulation, which exists to eliminate the risk of explosion associated with the transport of such energy dense cargo. The CMX series complies with transportation (UN 38.3) and safety (UL2054 2nd ed. and IEC61233:2012) as well as electromagnetic compatibility (EMC) regulations (CE and FCC). The range charges between zero and +40 degrees, discharges between -10 and +50 degrees and can be stored between -20 and +60 degrees. This results in 500 cycles of 80% minimum rated capacity. This development means that hospitals can now perform routine power management checks without having to remove the medical device from service using the smart charger that accompanies the CMX battery. A single charger can be used for different sized batteries, because the two devices automatically
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Part of our branded Entellion range, the CMX meets stringent regulations, demanding development schedules and innovation aims, whilst minimising unit costs Neil Oliver, Technical Marketing Manager, Accutronics
communicate exact voltage requirements and for customer convenience, two chargers are available to accompany the CMX series, an internal single channel charger and an external dual bay desktop charger, which can also be used for battery calibration. Whether batteries or chargers, the Entellion range is made to be customised. Options include product labelling and case colours, software setup and SHA-1 algorithmic security, which prevents counterfeit batteries being used under fraudulent warranty claims.
www.accutronics.co.uk
Enhancement
Vernacare introduces a new commode chair that is cleaner by design Vernacare, headquartered in Bolton, is a leading infection control organisation, whose innovative single-use system and award winning products have made it a global leader in human waste management across the healthcare sector. Well known for its single-use system, Vernacare has now developed a new commode chair - introducing a robust, easy-clean design - to help reduce the
risk of Healthcare Associated Infections (HCAIs). The new VernaChair has been developed collaboratively with clinicians from across the healthcare sector, to increase patient safety.
The new commode chair is constructed from strong, corrosion resistant materials, making it the one of the most durable product on the market. The stainless steel frame and plastic moulded parts are easy to remove and can be cleaned using a variety of methods. Wayne Nelson, Product Design Engineer, Vernacare
The new commode chair has been independently evaluated by a leading international test house to all applicable areas of quality standard BS 4751 : 2005 Mobile Sanitary Chairs. This included stability and strength tests on areas such as the arms, backrest and footrest, demonstrating the unmatched durability of the chair. The new VernaChair commode is cleaner by design and directly addresses HCAI transmission concerns associated with this type of equipment. A recent study by Van der Velden et al. identified commode chairs as a high-risk surface, with regard specifically to vancomycin-resistant enterococci (VRE) transmission1. Studies like this further highlight the infection risk presented by commode chairs within a healthcare environment. With castors enclosed in a protective shield to help prevent debris collection, and an easy-clean removable footrest, the new features of the VernaChair help to minimise the risk of infection transmission in such a critical piece of equipment. To assist the introduction of the new product, Vernacare will continue to offer educational support to customers – including ward-based training, commode audits and posters highlighting best practice for the sluice room. “Support and education is an important part of our offer. By reducing the time it takes to dismantle and clean the commode, we contribute to helping hospital wards become more productive,” added Emma Sheldon. “Most importantly, having a product that is easier to clean leads to increased patient safety and lower infection rates.” The new VernaChair comes at a time when healthcare organisations are looking to implement interventions quickly to tackle spiralling HCAI costs. In Europe alone, it is estimated that around 4.5 million episodes of HCAIs are reported each year, with the cost to the UK NHS now widely believed to be in excess of £1bn annually.
www.vernacare.com
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NICE publishes Medtech Innovation Briefing on ZedScan The National Institute for Health and Care Excellence (NICE) has developed a Medtech Innovation Briefing (MIB) on Zilico Ltd’s cervical cancer diagnostic system, ZedScan. NICE first developed the briefings in 2013 to help boost and speedup the uptake of innovative and promising technologies which have the potential to improve patient health and increase NHS productivity. Medtech Innovation Briefings provide a description of a medical technology, including its likely place in therapy, the costs of using the technology and a critical review of the strengths and weaknesses of the relevant published evidence. The MIB states that this economic evaluation is a “well executed document with a clear statement of limitations and assumptions.” Pg 28, NICE Medtech Innovation Briefing 20 (2015)
The purpose of the MIB is to provide objective information on device and diagnostic technologies to aid local decision-making by clinicians, managers and procurement professionals. By making this information available, NICE helps to avoid the need for NHS organisations to produce similar information for local use.
The NICE MIB for ZedScan identifies three key benefits from the report: “For both the ‘see and treat’ and ‘triage’ clinics, the model showed a reduction in overtreatment, adverse events and related treatment costs.
The NICE MIB has been developed on ZedScan as an adjunct to colposcopy in women with suspected cervical intra-epithelial neoplasia.
“Lower biopsy rates were associated with the ZedScan, with 1–1.02 biopsies per woman having colposcopy with the ZedScan compared with 1.72 with standard care, and this reduced related costs. “A cost saving was also illustrated from the reduction in follow-up colposcopy appointments over the timeframe of the model.”
The ZedScan system is used alongside colposcopy on women identified with an abnormal smear result.
Pg 26 - 27, NICE Medtech Innovation Briefing 20 (2015)
ZedScan offers clinical benefits by identifying those patients who require treatment at first visit, reducing the number of cervical biopsies performed on each patient by pin-pointing the optimum site for biopsy and reducing follow-up appointments - benefiting the patient and the hospital. These benefits translate into better health economics as identified in an independent report by the School of Health and Related Research (ScHARR).
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ZedScan is a portable and non-visual/non-optical system. The MIB also states that “NICE is not aware of any other CE Marked devices that have a similar function to the ZedScan”. Pg 8, NICE Medtech Innovation Briefing 20 (2015)
The NICE MIB follows the publication of a peer-reviewed multi-centre study in BJOG: An International Journal of Obstetrics & Gynaecology, and the health economics evaluation and a real-clinic case study on over 500 patients. .
www.zilico.co.uk
Enhancement
Willgo Wheelchairs‌ enhancing mobility The Willgo Wheelchair is a revolutionary new design in the UK mobility market. The Willgo team identified an opportunity to develop a wheelchair that would allow a disabled person to move easily between indoor and outdoor environments whilst being user-friendly, comfortable to use and enhancing wellbeing. Conventional wheelchairs allow movement around the home or in a work environment, however to travel further distances outdoors or to tackle rougher terrains an electric scooter or car is generally required. Willgo Wheelchairs is an ergonomically designed system that is propelled using levers rather than the hand rims, which offers a more comfortable propelling position for the user promoting better posture and easy breathing. The Willgo Wheelchair offers a unique transmission system, which allows the user in one easy movement to engage more manual power and maneuverability, enabling them to travel greater distances and across
a variety of surfaces. This ultimately offers greater independence, reduces the need for using electric powered wheelchairs and removes the inconvenience of having to switch modes of transport to negotiate different terrains. This is partly due to the innovative breaking system, which works in combination with the manual transmission enhancements, and means that each wheel can be controlled independently allowing the user to travel over rough ground such as grass or gravel, which typically would bring a conventional chair to a halt. The chair also has enhanced integrated safety features, which include a lap strap and an anti-roll back system. Operating the chair with levers benefits the user in that less stress is placed on the wrists than with a conventional chair, this helps prevent
strain on both the wrist joints and the shoulders. The suspension built into the front of the chair also means that it is easier to control and offers a smoother ride. Through work with Medilink East Midlands, Willgo have received grants towards patent filings and have been able to conduct innovative market research to further aid development. Willgo Wheelchairs are currently in operation in the UK, France, Germany, Canada, and America and are keen to develop their customer base. The company is striving to raise finance for greater volume manufacturing to help reduce costs enabling supply to retailers, distributors and health services, allowing more people to benefit from this new improved design.
www.willgowheelchairs.com
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Time for Medicine’s cloud-based platform for patients Most of us these days fly internationally. Having made our online booking, prior to the day of departure we go back online to book our seat, perhaps select a meal or provide information of where we will be staying, if disabled request assistance, and of course check in. Compare this to attending a medical appointment at a hospital to see a specialist. Apart from a letter from our GP to the hospital, we just turn up- and this is for our health! Time for Medicine, a spin-out from the University Hospital of Wales in Cardiff, is using cloud-based technology to improve the flow of information between patients and hospital based specialists. There are over 100 million outpatient appointments each year in the UK, costing over £20bn, which is an astonishing 20% of the NHS budget. For many patients, especially the elderly, attendance is an issue and can be costly, especially for patients in nursing homes. However, for specialist
clinicians who are by definition experts in their field, most first and follow on appointments are routine, and many could be avoided if the appropriate information was made available in the right form at the right time. The company’s web based platform enables patient interfaces, customised by specialty, to be presented to patients remote from the specialist, and for the resulting patient data to be presented to the specialist via a customised clinical dashboard. This potentially allows the specialist to come to a diagnosis in a highly efficient way without seeing the patient in person. The data can be entered from a patient’s home, in a GP’s surgery or in pharmacies. Time for Medicine has achieved this through the active engagement in the design process of over 50 of the UK’s leading clinicians in 20 specialties, which represent over 30% of outpatient appointments.
The first modules to be released are in dermatology, the most common reason people go to their GP, allergy, which afflicts over 3 million of us, and sexual health, where a more discreet service is often welcomed.
The company’s objective is to enable remote diagnosis where possible, therefore reducing physical referrals and by implication waiting lists and waiting times. Where face-to-face appointments are still required, the duration of the appointment will be reduced, improving clinic throughput. For patients who are critical on for example a cardiology waiting list early diagnosis can be lifesaving.
www.timeformedicine.com
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FUTURE WATCH Printing spare parts for spines A Nottingham dental laboratory is set to pioneer a “groundbreaking” new medical procedure that will create custom-made spinal implants for patients. Medilink East Midlands member, Attenborough Dental will transfer digital 3D printing technologies used in the dental profession to orthopaedics for the project. Managing Director Ed Attenborough said the proposal was not being trialled anywhere else in the world and that he expects 24 patients to be fitted with one of the custommade devices by the end of 2015.
At the moment, nearly all of orthopaedics is generic. Patients are made to fit the artificial implant, via surgery, instead of the implant being made to fit the patient In many scenarios, the implant will need replacing after several years or a second operation will be necessary. We are proposing to scan the patient in 3D and then produce a custom-made spinal implant for the patient using 3D printing and manufacturing technologies. In the beginning, we are just going to be looking at spinal implants but in theory the process could be expanded to knees or hips, for example. Ed Attenborough Managing Director Attenborough Dental
The company secured £146,000 from Innovate UK for a partnership with the University of Nottingham and the Nottingham University Hospital’s NHS Trust. The funding has enabled the company, which celebrated its centenary last year, to employ a post-
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graduate research assistant for two years from August 2014. Attenborough Dental, one of the last manufacturing business in the Lace Market, will create a centre of excellence at its headquarters in George Street, where it will teach surgeons the new processes and protocols of the spinal implant project. Since its inception in 1913, the company has grown to become one of Europe’s largest dental laboratories and operates in more than 20 countries worldwide. Exported manufactured products, such as dental brushes, now account for 85 percent of its overall income. Mr Attenborough said, “The most important part of our proposal is that we have all the facilities needed at our head office. We have a 3D patient scanning centre on site which has an accuracy of up to 20 microns. We also have a 3D printing and manufacturing centre on site, accurate to five to 16 microns working with materials such as titanium and ceramics such as zirconia. We have a very unique set-up here in Nottingham with all the technology needed for the proposal under one roof, which allows us to develop an integrated product and new treatment protocols. Nottingham has one of the largest teaching hospitals in the country at its heart as well as a world-leading academic centre in 3D printing at the University of Nottingham.”
Attenborough Dental joined the Invest in Nottingham Club in 2012, bringing its knowledge of selling overseas to the organisation’s expert committee. Invest in Nottingham interim chief executive Simon Gray said, “This new project is testament to how cuttingedge the firm is and shows how it continues to put Nottingham on the map in terms of innovation and creativity.”
www.attenborough.com
Future watch
Glyconics’ licence to breathe Glyconics Limited, an innovative UK diagnostics company, has secured an exclusive global commercialisation licence from Swansea University for the use of its intellectual property in the use of IR spectroscopy for the diagnosis of chronic obstructive pulmonary disease (COPD). COPD is an umbrella term to describe a range of chronic lung diseases that cause limitations in lung airflow, and includes chronic bronchitis and emphysema. In the UK, COPD is estimated to affect some six million people and is responsible for more than 25,000 deaths annually but around half of sufferers are said to be unaware of their condition, which can put extra strain on hospitals further down the line. Poor recognition and treatment of respiratory failure increases the risk of mortality. The technology was originally developed by Dr Paul Lewis and his team at the College of Medicine, Swansea University. They were able to identify specific biomarkers in sputum which are characteristic of COPD patients and can be easily and rapidly analysed using non-invasive
IR spectroscopy, and Glyconics is planning to utilise this technology to develop a diagnostic for COPD. The licence will enable Glyconics to launch a laboratory based and portable version of its device for both the identification of COPD patients and, most importantly, the early identification of exacerbation events. Collectively the clinical management and loss of productivity due to COPD in the UK equates to £4 billion to the UK economy per annum so accurate diagnosis and early identification of exacerbation is likely to significantly impact disease management. In particular, the early identification of exacerbation will enable earlier therapeutic intervention and avert the incidence of hospitalisation of these patients and substantially reduce associated healthcare costs. Full commercial details are not disclosed, but future payments will be based around royalty payments on sales and commercial milestones. Head of Intellectual Property for Swansea University, Dr Gerry Ronan commented, “We are delighted to conclude the licence with Glyconics
With this licence secured, we can move ahead to launch our technology into areas of unmet clinical need where there is very little genuine competition. Given the global significance of COPD as a major clinical problem we will be looking to rapidly identify commercial partners who can assist in the rapid deployment of our devices into the major global markets. Importantly we are also continuing to work very closely with Swansea University to build a development pipeline around other signatures. Dr Berwyn Clarke CEO, Glyconics
who are rapidly moving forward towards the commercialisation of the University’s IP. There is a significant unmet clinical need in this area, coupled with a large global untapped market, and Glyconics is ideally placed to exploit this.”
www.glyconics.com
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Fighting disease with technology Novarum DX is using its mobile technology in the fight against Ebola and HIV/AIDS, giving healthcare workers the ability to instantly read and share diagnostic tests across the globe, using nothing more than a smartphone. Based in Edinburgh, Novarum is a joint venture between Scottish tech company Albagaia and a leading manufacturer of raw materials and test platforms for the in-vitro diagnostics market. This collaboration allowed for the creation of advanced smartphone-based readers for the mHealth, veterinary and food sectors, which capture results from diagnostic tests and present the user with an accurate reading in seconds. These results are then shared with a secure database using the phone’s in-built connectivity. Novarum’s readers have already been used in Africa to monitor HIV treatment - bringing the lab to some
of the continent’s most resource-poor and remote locations- and chronic bowel disease sufferers have also seen benefits, with Novarum’s reader helping them maintain their daily routine without intrusive testing at their doctor’s surgery. The company is now expanding its product offering and has ambitions of growing its portfolio. Recent developments have included Bluetooth solutions, colourimetric reading apps, tracking apps and technology to aid the visually impaired. Novarum is currently working with a partner to develop a reader which will accurately identify any positive reading for Ebola via a rapid point of care test. Building on a simple to use diagnostic test from specialist defence diagnostic manufacturer, BBI Detection, Novarum has developed an application to read and share the results of BBI’s Ebola test, using nothing but a smartphone. This first of its kind app was recently demonstrated at the GSMA Mobile World Congress in Barcelona. Company Managing Director, Neil Polwart, commented, “With over 23,000 cases globally, over 9,000 Ebola related deaths, and concern over misdiagnosis due to the symptom similarities with malaria, it is clear that something needs to be done to make testing for Ebola simpler and more accessible. One of the issues with point of care testing is the human error risk involved in visually reading a test.
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Another is the delay in sending tests to a lab for confirmation. Our application addresses both of these issues. “We are excited to be part of something that really could make a difference to a global crisis. Whether the app is used in West Africa where facilities are limited, for precautionary measures at border control, or indeed to track positive cases of the virus globally, we believe that this simple to use, low cost technology has the potential to impact the spread of Ebola in a very positive way. Novarum is also breaking into the competitive US marketplace, and is currently assisting a client to seek approval from the Food and Drug Administration (FDA) for its technology. They are confident of success, which would make their smartphonebased reader the first to receive FDA approval.
Scotland has a thriving tech community and we’ve had the pleasure of working with a handful of other Scottish SMEs over the years. Scotland itself has a unique and recognisable brand respected the world over, which SE and SDI make good use of. Our experience of doing business in Scotland has certainly been a positive one thanks to support from SE and SDI. There’s a real sense of camaraderie with other Scottish companies when breaking into international markets. Nicole Irvine Market Development Manager Novarum DX
www.novarumreader.com
Future watch
Medilink supports pioneering tissue repair technology
TAOS™ allows a regenerative, malleable biomaterial to be injected into the site of tissue damage, removing the need for complicated and invasive surgery. Once the treatment has been administered the material stimulates the body’s own repair process before degrading to naturally leave behind newly formed tissue. The process is intended to reduce rehabilitation time and postoperative complications, ultimately improving the patient’s experience.
Musculoskeletal diseases affect hundreds of millions of people worldwide and are a leading cause of chronic pain and disability. TAOS™ offers multiple medical applications in the field of advanced tissue repair, with potential benefits in treating spinal conditions such as curvature of the spine and the removal of slipped disks, alongside use in ‘hard to heal’ or nonunion fractures.
Locate Therapeutics required further laboratory research and specialist equipment to develop and finetune their biomaterials and surgical procedures, which has been supported by the grant. Temperature Change
Injectable Paste
Adhesive Particles
Tissue Repair Scaffold
Locate Therapeutics Ltd, a Nottingham based specialist regenerative medicine company has been awarded a grant from the Healthcare and Bioscience iNet, a project delivered by Medilink East Midlands and part-funded by the European Regional Development Fund (ERDF), which will allow further development of their TAOS™ technology (Targeted, Orchestrated Signaling) - a world first in tissue repair.
Injectable Paste
Cohesion
Liquid Sintering
How Does TAOS™ Work?
of information for a surgical team administering treatment to a patient. We have three key projects starting over the next few months, and this will greatly help speed along the development process to clinical trials.” Dr Neil Barnes, Innovation Adviser, Medilink East Midlands commented, “Developing new technologies, processes and products is a key aim of the Healthcare and Bioscience iNet initiative, and this is a prime example of how engaging with Medilink can help businesses achieve their aims. The potential for further development in the field of biomaterials is huge, with associated cost savings for the NHS and benefits to patients who will have
Scaffold preparation
Robin Quirk, Co-founder of Locate Therapeutics commented, “The Medilink funding will help us take our research to the next level. Having this equipment available within our laboratory removes a bottleneck in the development of TAOS.™ It will significantly increase the speed at which our scientists can test the stability of the polymeric materials we use, as well as determine the viscosity and setting times of the biomaterials generated - both essential pieces
a faster recovery time and a much more simple and localised treatment.” The versatility of the TAOS™ technology means it can also be applied in orthopaedic medicine for precision delivery of antibiotics and drug delivery where controlled sustained release is required. TAOS™ technology is also applicable in numerous clinical disciplines including cardiology, neurology, orthopaedics, dentistry and reconstructive or cosmetic surgery.
www.locatetherapeutics.com
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New non-invasive system aims to reduce the incidence of Diabetic KetoAcidosis Oxford Medical Diagnostics (OMD), a leading developer of advanced proprietary methods of analysing volatile organic compounds (VOCs) in breath, is working with Renfrew Group International (RGi) for the engineering and industrial design of a portable breath analysis device. The collaboration will combine OMD’s scientific research expertise with RGi’s design capabilities to further develop an accurate, low-cost, portable and non-invasive breath analysis platform to identify and monitor certain metabolic and infectious diseases by detecting and measuring VOCs in breath. OMD’s platform is based on the company’s main proprietary technology, Cavity Enhanced Absorption Spectroscopy (CEAS), which was developed at the University of Oxford. The current prototype device is capable of measuring acetone in breath samples at sub-parts-per-million levels, which is in excess of the sensitivity required to detect acetone levels of patients with Type 1 diabetes. The device is designed for use in Type 1 diabetes, as an aid to diabetes management and to help prevent the onset of Diabetic KetoAcidosis (DKA). In recent months, the prototype system was successfully used in its first clinical evaluation, successfully measuring breath acetone from over 100 samples.
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OMD has been awarded further SBRI funding and two TSB grants to support the development of multiple units for the next phase of clinical trials in collaboration with an expert team at AddenbrookesHospital in Cambridge under the direction of Dr Mark Evans.
The early model (pictured) will support obesity prevention and is currently being tested and evaluated in clinics. A smaller consumer orientated device is also being developed.
www.omdiagnostics.com
Future watch
N4 Pharma… one to watch N4 Pharma is a start-up specialist drug re-formulation company, focused on developing and out-licensing new versions of existing high value drugs with an unmet commercial or medical need. Founder, Nigel Theobald identified a commercial opportunity in the pharmaceutical market, whereby large pharmaceutical companies sought to recoup some of their initial investment in flagship brands, by capitalising on and extending their value through drug re-formulation. Bringing new drugs to market is a costly and precarious business and can take over 10 years and cost in excess of £1bn. Therefore, re-formulating existing products is crucial to adding value to these already well established brands. N4 Pharma operates in the niche area of re-formulating existing products and improving their performance. Its
business model includes developing the initial clinical data required to enable itself to partner with a larger pharmaceutical company, and ultimately accelerate the new reformulated drug through regulatory approval. For the pharmaceutical company this is a winning concept, as the process ultimately reduces any development risk and results in faster market access to the re-formulated drug. Working closely with Medilink East Midlands, N4 Pharma has secured a grant to support two of their reformulation projects. One of these is Cocrys® - a patented process from the University of Bradford designed to improve drug solubility. This is the first commercial process allowing the large-scale manufacture of cocrystals, which have previously not been available for pharmaceutical companies on a commercial scale.
In addition, a project to enhance the delivery system for vaccines is being developed in partnership with the University of Queensland. The new delivery system is loaded with tiny nano-sized silica vesicles, which when administered to the patient improves the vaccination’s performance. This is being developed specifically for a new improved version of the Hepatitis B vaccine.
www.n4pharma.co.uk
Packaging Innovation for Healthcare WIPAK high-end packaging solutions provide safe and reliable sterile barrier systems for medical devices, pharmaceutical solutions and other healthcare products including antimicrobial treated films, papers and pouches.
www.wipak.com
T +44 1938 555255 Wipak UK Ltd, 3 Buttington Business Park, Welshpool, Powys, Wales, UK. SY21 8SL
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We care that you pack safely
£2m funds ground-breaking technology to detect cancer during surgery New imaging technology which enables surgeons to detect cancer in real time during operations for the first time has moved a step closer to market thanks to a £2m ($ 3.1m) funding round by UK medical device company Lightpoint Medical. The molecular imaging technology aims to tackle the high rate of repeat operations undergone by people with some cancers, most notably breast and prostate cancer. Currently around one in four women in the UK undergoing surgery for early-stage breast cancer requires at least one reoperation because there is no accurate way to detect microscopic cancerous deposits during the operation, with surgeons relying on look and feel to make a judgement. In many cases, this means that cancerous tissues are not completely removed, leading to at least one repeat operation. The company’s new investment will enable it to take its two lead products to Europe and the USA next year – the LightPath specimen analyser, which enables rapid molecular imaging during surgery, and EnLight, a hand-held molecular imaging fibre optic camera. Lightpoint Medical expects to receive market approval for the technology in 2015.
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Dr David Tuch, CEO of Lightpoint Medical, says, “The level of investment we have raised reflects the real clinical demand for this technology, and therefore its enormous market potential. The current rate of reoperations comes with a high cost to patient well-being and healthcare budgets, and we are very pleased that the funding will help bring our products to people who need them.”
Being an investor in Lightpoint has been a pleasure. From the initial investment, everything has gone better than expected. This happens only rarely. In Lightpoint’s case, the technology has worked. More grants have been received than initially hoped. It has been easy to attract new investors. Most importantly, surgeons have been enthusiastic about using the technology, since it has the potential to dramatically improve outcomes for patients. Lucius Cary Managing Director Oxford Technology
Dr Eliot Forster, Executive Chair of MedCity says, “This is a deservedly successful investment round that highlights the value of being flexible about your funding mix and pulling all the levers to access the investment you need. There is a growing sense of confidence and ambition in the UK’s life sciences sector right now, and access to investment is absolutely key to that momentum. Lightpoint demonstrates that there are great opportunities for investors in the sector, and that an exciting product with clear market demand won’t struggle to get funding.” MedCity recently launched Angels in MedCity, an initiative to significantly increase the level of angel investment available to emerging life sciences companies through a programme of free workshops and pitching events. Lightpoint Medical was founded in 2012 to develop and commercialise surgical imaging technology based on Cerenkov Luminescence Imaging (CLI). CLI enables optical detection of Positron Emission Tomography radiopharmaceuticals, combining the advantages of optical imaging – including low cost, high resolution and portability – with the high diagnostic performance of PET imaging.
www.lightpointmedical.com
Fresh thinking. At Grant Thornton, we go about our business in a different way. Delivering a bespoke service to all our clients is our primary concern and we won’t offer you an ‘off the shelf’ commercial or financial solution. With our knowledge of the market, and our international reach as the UK member firm of the Grant Thornton International network, we can provide a full range of advisory services for companies in the life sciences sector, whatever stage they are at in the business cycle. We act on behalf of listed, privately held and private equity backed pharmaceuticals, medical devices and biotechnology companies to provide solutions when key business decisions are made, such as raising funds, seeking investors and acquirers, or financial planning and modelling.
For further information on our life sciences offerings or to arrange an initial consultation, please contact: Alistair Wardell Partner – Advisory T 029 2023 5591 E alistair.g.wardell@uk.gt.com
grant-thornton.co.uk © 2015 Grant Thornton UK LLP. All rights reserved. Grant Thornton UK LLP is a member firm of Grant Thornton International Ltd (GTIL). GTIL and the member firms are not a worldwide partnership. Services are delivered by the member firms. GTIL and its member firms are not agents of, and do not obligate, one another and are not liable for one another’s acts or omissions. Please see grant-thornton.co.uk for further details.
GOING GLOBAL Co-Formulate working with Medilink EM Co-Formulate is a contract pharmaceutical development organisation with the expertise necessary to translate product concepts into feasible commercial product technologies. Set up in 2007, it has built an enviable reputation working with organisations from global blue-chip to SMEs and academic groups. A move into larger laboratories at MediCity provided an opportunity for service expansion and reduced the need for outsourcing services. The Co-Directors, Huw Jones and
Medilink East Midlands continues to provide us with support and beneficial business opportunities. The grant derisked our move to bring more of our analytical services in-house while the SIG has enabled us to meet businesses and researchers associated with one of the markets we have targeted for expansion, as well as raise our profile in this area. Nazim Kanji Co-Director, Co-Formulate
Nazim Kanji, approached Medilink East Midlands for support and the programme provided grant funding to assist in the employment of a highly skilled analytical scientist to develop and manage an expanded analytical and stability testing service. The creation of the Food Supplements Special Interest Group (SIG) has also proved timely for Co-Formulate, providing an ideal forum in which to commence their expansion into the food supplement arena.
www.co-formulate.co.uk
GBUK Ltd leads international push for new enteral ISO standard GBUK Ltd, one of the UK’s market leaders in enteral consumables, recently showcased its range of products, which have been prepared for the new Enteral ISO directive, at MEDICA and Arab Health. The North Yorkshire-based company, exhibited its products including enteral syringes, nasogastric tubes and dilators – all available with the new connector – at both shows, confirming GBUK Ltd as a global player in the enteral market. In an effort to improve patient safety, new international design standards for medical device tubing connectors will be released in early 2015 as part of a phased global initiative. GBUK has already developed its range of products to meet the requirements of the new ISO standard for connectors and ensure its customers are prepared well in advance of the change.
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We are proud to manufacture and distribute the highest quality medical products. Each day more than 110,000 GBUK products are used to care for patients in the UK. GBUK is well advanced in its preparation for this significant development in the enteral market – which means our customers and their end-users will also be well prepared. Marcus Ineson, Marketing Director, GBUK Group
GBUK met with the Rt Hon Earl Howe, Parliamentary Under Secretary of State for Quality, during his tour of the UK Pavilion at the opening day of Arab Health 2015 in Dubai, where he praised the company’s desire to build momentum in the Middle East.
www.gbukhealthcare.com
Going global
HALO enhances cell data reporting Established in 2005, Histologix is one of Europe’s leading independent GLP/ GCP - compliant contract histology, immunohistochemistry (IHC) and InSitu Hybridisation (ISH) service providers to the Pharma-Biotech industry. It provides specialist human tissue-based solutions in support of regulatory preclinical programmes, clinical trials and biomarker development and validation projects. The Histologix team of scientists undertakes testing and screening projects on behalf of clients that range from the discovery stage of drug development, through to regulatory safety screening and clinical trials and the range of services provided use highly sophisticated technologies and platforms aimed at standardising the various processes involved in data generation. This promotes consistency and accuracy and will ultimately assist clients in the development of their drug programmes. In recent years, there has been a huge change in the ImmunohistoPathology market, with the adoption of personalised medicine and an increasing requirement to find a means to stratify patients for therapy. Histologix identified this gap in the market and capitalised on the business opportunity as until recently, pharmaceutical businesses had very few choices available to them for the specialist services in ImmunohistoPathology. With digital technologies advancing rapidly within the histology field, David Fairley, Managing Director, saw an opportunity to expand its specialist services into complex digital image analysis that would support the drive by the Pharmaceutical industry to develop targeted therapies more quickly, more accurately and more efficiently allowing a personalised healthcare approach to many different diseases. In order to further develop and fasttrack their services, the directors
Halo automated tissue classification of liver stained using a cytokeratin marker & VENTANA purple chromogen – the algorithm overlay is green for tumour or parenchymal tissue and yellow for stroma while pink is white space. It is possible using this system to train the tissue classifier to automatically identify specific types of tissue
worked closely with Medilink East Midlands who helped them secure funding through the Healthcare and Bioscience iNet and they are partfunded by the European Regional Development Fund (ERDF) to buy vital pieces of equipment including a whole slide digital scanner from Hamamatsu and HALO™ image analysis software from Indica labs. The team at Histologix has successfully incorporated the new technologies into their clinical services greatly enhancing their facilities.
HALO™ measures and reports on individual cell data and maintains an interactive link between cell metrics and cell imagery. The ability to data mine millions of cells while visually assessing corresponding cell populations opens the door to remarkable discoveries whilst the digital scanner converts pathology glass slides into digital slides, which can be easily manipulated, copied and shared in a variety of applications between healthcare professionals.
The funding that Medilink has helped us secure has played a part in allowing us to achieve our commercial goals. Last year (20132014) we grew the business by 65%, which without those 2 pieces of kit this would not have been possible. We are almost 6 months into our current financial years and are about to sign 2 studies that will surpass our turnover for the entirety of last year. David Fairley Managing Director Histologix
The new technologies have allowed Histologix to enhance their service offering in the fields of personalised medicine, biomarkers and companion diagnostics and in addition, Histologix is now trading throughout Europe, Belgium, France, Holland, Germany, Austria, Denmark, Sweden and Norway, Switzerland, Russia, South Africa, China, USA and Canada.
www.histologix.co.uk
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Nottingham’s Scandinavian initiative Five Nottingham-based drug discovery companies teamed up with UK Trade & Investment (UKTI) in the hope of discovering Scandinavian sales. The businesses headed to Denmark on a market visit entitled, “The Changing Face of Pharmaceutical Discovery and Development – A Collaborative CRO Approach” which provided an opportunity for life science research companies across the Nordic region to meet and discuss how collaborative 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 across the world are looking to outsource their research activity, which of course offers immense opportunities. The Scandinavian companies are keen to meet these businesses, as Nottingham is renowned as a centre of discovery and innovation. By joining together to present their business to these companies they are showing the journey in drug discovery activities.” The companies who attended complement each other in their drug discovery activities and product
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development. Aurelia BioScience covers compound screening to identify hit and lead molecules and organic synthesis is taken care of by Charnwood Molecular. XenoGesis is a specialist in drug metabolism and pharmacokinetics (DMPK) testing and Reach Separations provides analytical and chromatographic expertise, particularly for chiral compounds. Molecular Profiles provides pharmaceutical development services and clinical trial manufacturing for small molecules and can work from early phase development to late stage clinical manufacture. Glasgowbased Biopta addresses the issue of translational relevance, proving data from tailored fresh human tissue assay systems; interfacing with the other groups by testing novel molecules for efficacy, absorption or safety in healthy and diseased tissue. The meetings were hosted at the British Ambassador’s residence in Copenhagen, and gave the companies the opportunity to meet with a range of businesses based across the region. UKTI was able to offer the companies attending the mission funding, and help in identifying other sources of funding to support the market visit. This market visit followed a successful two-day visit to Switzerland last year organised by UKTI.
Attracting new business is essential to our success. By having this collaborative approach and offering a comprehensive range of drug discovery activities, we are confident in providing an attractive proposition to Nordic companies seeking support with their research projects. Clients recognise the value of specialist expertise and appreciate the quality and turnaround speed that dedicated organsisations can provide. Richard Weaver Managing Director XenoGesis We all have a strong understanding of each others capabilities and how we can work together effectively to become more competitive. As companies become more confident with outsourcing, the way they approach it is evolving. The need for a collaborative approach of bringing services together in this way is only going to grow. Peter Ridgway Business Development Director Reach Separations
The Bill Mapleson Centre A new state-of-the-art centre based in the Cynon Valley: Medical Device Testing Unique testing facilities for a wide range of medical products. Built on the expertise and years of experience in testing medical devices for industry and the MHRA at the Department of Anaesthetics in Cardiff University. Clinical Consultancy Access to health care professionals with a wide variety of expertise in anaesthetics, pain and critical care. The Department of Anaesthetics has a long history of collaborative research with industry partners. Training Courses / Simulation Training courses with high-fidelity simulation and video recording / playback facilities. For more details please visit: http://blogs.cardiff.ac.uk/bmccu/ @ CardiffBMC For inquiries please contact Jeff Clark: clarkj11@cf.ac.uk or 029 2074 4886 Bill Mapleson Centre, Cwm Cynon Business Park, Mountain Ash, CF45 4ER
MADE IN THE UK The BioHub Birmingham® set to be the region’s ‘biomedical innovation launchpad’ Based at the heart of the long-standing Edgbaston Medical Quarter, the new BioHub Birmingham is a pioneering project that will provide much-needed laboratory facilities as a launchpad for medical innovation in the region. The team behind it have a vision of a core community of start-up and early-stage companies bringing their innovative medical developments to market all under the same laboratory roof.
Based on the ‘plug and play’ concept catching on fast in the US biotech sector, The BioHub follows the model where the laboratory, equipment and office space are available immediately, at an affordable cost. The BioHub will be an interactive community of innovators sharing ideas and gaining inspiration from their contemporaries.
When James Wilkie, CEO of Birmingham Research Park, began his role in 2007 the tenant base at the Science Park was predominantly focused in the medical sector, but there were no early stage entrepreneurs in the mix. It became clear that start-up ventures needed to be attracted, and the route of providing a shared space facility seemed to be the logical solution. After securing funding from the University of Birmingham, the European Regional Development Fund, and Birmingham City Council, the leadership team including Business Development Manager, Helen Miller-Viney, is now on its way to creating the community they
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envisioned. The impressive £7million facility will shortly be opening with Sartorius Stedim Lab and Bioscience Ventures Ltd already about to take up residency. The 4,500 sq. ft. laboratory facility is the first of its kind in the UK, boasting specialist rooms including areas for Category 2 microbiology, a freezer facility down to -150°C, a microscopy lab, sterilisation facilities and a cryogenic suite for housing liquid nitrogen. There are office desks and hi-speed broadband provided, and if the tenants require, business advice and guidance available in, BizzInn, the business incubator just nextdoor and also part of the The BioHub Birmingham® project. “When you’re really focused on turning an idea into something tangible and also at the very early stage of setting up and running a business,” James adds, “it can be hard to step back and look
at everything, so having experienced professionals to mentor can make all the difference. “Now start-up biomedical companies can have access to affordable wet-space and advanced research equipment plus science and business support – to give them everything they need to transform their ideas into commercial reality.” “It’s all about the community,” he adds. “We want to create a place where conversation can stimulate new ways of thinking. I strongly believe that a group of inspired people is just as important as building the right kind of space and installing the right kind of equipment. When you’re new to entrepreneurship, you need this kind of social environment.”
www.thebiohub.co.uk
Made in the UK
Welsh design engineering from GX destined to prevent global water contamination Welsh expertise in life sciences is helping to combat the growing problem of global water pollution. One of Wales’ leading innovative and dedicated product design engineering companies, GX Group, has been working in conjunction with Cardiff University and water technology company Modern Water. Together they have developed an online analytical toxicity instrument – the Microtox CTM that uses life science technology to monitor water contamination. The initial drive to develop a ground breaking standalone online analytical toxicity instrument to measure water contamination came from Welsh based company, Cymtox, who have since been bought by the global company Modern Water. Working in conjunction with Modern Water and Cardiff University, the design engineers at GX Group managed to harness ground breaking bioluminescent technology to test for water contamination. The Microtox CTM has been designed to provide an accurate and continuous indication of water quality in real time, which can be controlled and monitored via a colour touchscreen, or even remotely via the internet. Since the machine was destined to be sold to water authorities in the Far East the team felt it was important to develop a standalone unit which required little manual intervention. Another key consideration was a low manufacturing cost, since this would allow a final economical and competitive unit price.
The design team at GX Group worked on developing a simple industrial box like exterior which would hide sophisticated equipment to continually mix samples of bioluminescent bacteria with water. By monitoring the amount of light emitted by the bacteria to measure their health the machine could automatically monitor the water quality for contamination.
The entire project took just eleven months from the initial mechanical and industrial design, through to the addition of complex electronics to seamlessly interface with software allowing the Microtox CTM to be remotely controlled. By harnessing science and merging this with a practical design, Modern Water and GX Group raised the bar in online water toxicity testing with the first truly continuous online instrument. From an initial order for just six machines the team at GX Group continues to collaborate with Modern Water, most recently building a further 20 units. Such bespoke manufacturing of a low volume unit using life science technology is one of the key attractions that a company like Modern Water benefited from using a full service product design development company like GX Group.
www.gxgroup.com
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Implanting dental solutions in the UK Dental implants in the UK are notoriously expensive, so much so that many UK patients requiring implant surgery take a ‘Dental Implant Holiday’ to other European countries, where they can have the same treatment as at home, but at a fraction of the cost. Wollaton Implant Solutions Ltd has been set up to address this situation, and will be introducing a dental implant package targeted at the UK dentistry market to help drive down the price of dental implant procedures for patients in the UK. The company was founded and set up last year as a joint venture between Biomaterials Scientist Wei-Jen Lo and one of Nottingham’s leading dental technology laboratories. It was
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established following an introduction brokered by Medilink East Midlands. Through Medilink’s strategic mediation a joint venture between the two complementary companies was proposed, and the original concept of creating a unique dental implant package, the first of its kind in the market, was formulated. In addition to providing a much more convenient way to source components
for implant surgery, the package will also be much more cost effective. The entire package will cost less than one single dental implant currently costs in the majority of dental surgeries across the UK. Wollaton Implant Solutions are currently conducting clinical evaluation and feasibility studies with dental surgeries before launching toward the end of the year.
The package includes the implant, all the accessories including surgical equipment and the specialist, patient ready, custom-made titanium bridge and zirconia crown. The new concept provides dentists with a complete packaged solution and removes the time and cost of sourcing multiple materials from different suppliers.
Made in the UK
Synergy’s speedy solution for roadside drug testing Providing a wide range of drug and alcohol testing solutions to clients in all industry sectors, from many of the UK’s largest organisations to small, independent companies, MediWales member, Synergy Health Laboratory Services is considered a trusted expert in the area of fully managed workplace drugs and alcohol testing solutions. The end of 2014 was a particularly busy time for Synergy Health as its customers were preparing for the imminent change in Drug Driving legislation. Under the new offence of drug driving, the Police will simply have to show that the individual has taken drugs and was either driving, attempting to drive or in charge of a vehicle. The new offence will reduce the wasted time, expense and effort involved for the Police, the Crown Prosecution Service and the Courts when prosecutions fail under the existing offence in section 4 of the Road Traffic Act 1988.
The Dräger DrugTest® 5000 Following suggestions from a panel of expert witnesses, which includes both medical and scientific experts, the Department for Transport (DfT) put forward proposals which are now covered by the new offence. A zero tolerance approach has been adopted for eight controlled drugs which are known to impair driving: l Cannabis l Cocaine l Benzoylecgonine l LSD l MDMA (Ecstasy) l Ketamine l Methamphetamine l 6-MAM (Heroin/
Diamorphine)
The UK Government has approved the Dräger DrugTest® 5000 for roadside drug testing and as such, this is the device that the Police will be using when testing. The Dräger DrugTest® 5000 is an easy to use mobile drug screening system which uses oral fluid to test for seven types of the most commonly abused drugs. This quick drug test provides a non-invasive alternative to the current collection of urine samples. It is quick and simple to operate, with a user-friendly design and on screen instructions to guide the collection officer through the test. The unique configuration of the Dräger DrugTest® 5000 ensures that the device controls both analysis time and internal temperature for accurate, reliable results.
The legislation is now the law in England and Wales as of 2nd March 2015 and this date coincided with the changes being made to the current drink driving legislation.
A key feature of the Dräger DrugTest® 5000 is that the device provides an electronic result. This removes the need for interpretation and eradicates the element of human error. Synergy Health has an exclusive agreement with Dräger to supply the DrugTest® 5000 in the United Kingdom
www.synergyhealthplc.com
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MEETING THE UNMET Advances in the diagnosis and management of suspected pre-eclampsia
The current established diagnosis of pre-eclampsia involves blood pressure measurement and determination of protein in urine, the prognostic performance of which is quite poor. As a pre-eclampsia consequence many accounts for women with signs associated with pre-eclampsia are of all maternal deaths unnecessarily per year worldwide* hospitalised *Verlohren S et al. 2010 for intensive monitoring, resulting in significant additional costs to pregnancy care. There is an unmet medical need for short-term prediction of pre-eclampsia in pregnant women with suspected pre-eclampsia.
42%
New data from a multicentre prospective study (PROGNOSIS) addresses this and sets new standards in prenatal care. Roche introduces this new and reliable approach to predicting which women at risk will develop pre-eclampsia within short term, making a difference to the management of this life threatening condition.
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The Roche sFlt1/PlGF ratio has an extremely high negative predictive value which has the capacity to change the way in which we make our initial assessment of patients, permitting outpatient care and monitoring for those at low risk of the disease whilst focusing our inpatient care on those at highest risk of complications. This has benefits for the mother, the hospital and the clinician. Dr Manu Vatish Senior Clinical Fellow & Consultant in Obstetrics Nuffield Department of Obstetrics & Gynaecology, University of Oxford & the John Radcliffe Hospital, Oxford,
PROGNOSIS is a multicentre, prospective, double-blind, non-interventional study, which evaluated the use of Roche’s Elecsys® sFlt-1/PIGF ratio in the shortterm prediction of pre-eclampsia, eclampsia and HELLP (Hemolysis, Elevated Liver Enzymes, Low Platelet Count) syndrome in pregnant women with suspected pre-eclampsia. Presented at the 20th World Congress on Controversies in Obstetrics, Gynaecology & Infertility in Paris last December, the study findings showed that the measurement of the Elecsys® sFlt-1/ PIGF ratio is a reliable tool for identifying women at high risk of developing preeclampsia within the next four weeks in women suspected of pre-eclampsia. It
also allows clinicians to confidently send home the women with suspected preeclampsia that are not going to develop the disease for one week. The use of the assays can produce significant cost savings Put simply, introducing this test into clinical practice has the potential to reduce the number of women hospitalised prior to preeclampsia diagnosis by 50% (StrunzMcKendry, T. et al. 2014). allowing gynaecologists to focus on high-risk patients and send home those that will not develop pre-eclampsia for one week resulting in a reduction in the health care burden.
www.roche.co.uk
Meeting the unmet
Diabetics giving amputations the boot Diabetics once facing the prospect of amputation to their lower limbs due to the effects of foot ulcers are now back on their feet thanks to a new technology.
Foot ulcers are common for diabetics as they often suffer from reduced sensation on the skin. Even a slightly high blood sugar level can, over time, damage some nerves – a diabetesrelated issue called peripheral neuropathy.
If sensation is lost in parts of the foot, it can be difficult to know if the foot has suffered any damage. This also means it is difficult to protect small wounds by not walking on them – and the wounds can rapidly deteriorate and develop into ulcers. Foot ulcers are prone to infection and can quickly become severe and in some cases lead to amputation.
My podiatrist suggested I try a new type of total contact cast – and that I try it on both feet. I believe I was the first person in the UK to have been treated with the cast on both feet – and it worked brilliantly. I was absolutely amazed. After 12 weeks, I’ve virtually healed. William Hutchinson
can be applied in just ten minutes by the podiatrist. It works by promoting healing of the wound by minimising pressure and friction, as the TCC-EZ redistributes the weight away from the wounds, meaning it can heal even while the patient is walking. Emily Sambrook, Podiatrist Advanced Practitioner at Solent NHS Trust, said, “As a clinician, I’m always a little sceptical about new technologies – but the TCC-EZ is the best new technology I’ve experienced. Patients who have been seen for many months with little
improvement are now healing, in some cases, within eight weeks, which is absolutely fantastic. The TCC-EZ is an easy one-stop system– and means I don’t have to refer patients to have a plaster cast technician, at which point I might lose the patient in the system. This means I can progress a programme of care which allows the patient to follow the right routine and heal more quickly. The system also significantly reduces the chance of amputation. We can use the TCC-EZ to dramatically increase the healing process of foot ulcers by reducing planter pressures – which typically takes many months – and results in less risk of infection. Less risk of infection ultimately means less risk of amputation. Our patients often suffer from depression as they can’t do what they normally do and can’t see an end-goal. They will often ask how long the healing process will take. Using a traditional method, it’s very difficult to allocate a timeframe - but now I can provide an end-point based on evidence. The patients we’ve been dealing with have been amazed how quickly they are healing – and that has had a dramatic effect on their quality of life.”
This was the case for William Hutchinson, 57, from Havant, a Type Two diabetic who has suffered from recurrent foot ulcers on both feet for a number of years and was on the verge of having to have a toe on his left foot amputated. When Mr Hutchinson was referred to Solent NHS Trust’s specialist Podiatry Team at St James Hospital in Portsmouth, they suggested a very new approach – and the results were quickly evident. The technology is called the TCC-EZ – and is a Total Contact Casting system. Total Contact Casting is considered the gold standard of care for off-loading diabetic foot ulcers. Produced by Dermasciences Europe, the TCC-EZ is a one-piece, roll-on, woven cast that
William Hutchinson being treated with TCC-EZ
http://outside-us.dermasciences.com/tcc-ez.
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Bioscience crowdfunding platform launches for new and rare disease research A new and promising source of funding for research in the life sciences (specifically bioscience and biomedical research) is now live. FutSci is a revolutionary new platform designed by scientists and is the UK’s first dedicated crowdfunding platform for life science research. FutSci is being launched by Dr Deepika Kassen (a molecular biologist) and Dr Gayathri Perera (a Consultant Dermatologist and Immunologist). The concept evolved during years of experience at the sharp end of life science research and funding. It will provide a platform where accredited researchers and scientists can post any project in need of funding, at any stage, and donors can select the individual projects they wish to support. All projects are vetted prior to going live on the platform and all scientists are affiliated with recognised institutes.
There’s a major funding gap for life sciences in the UK. It isn’t just that there’s been no crowdfunding platform before FutSci; it’s also an absence of grants and funds for research into less well-known diseases and conditions, and a dearth of small-scale grants and funds for early stage projects. Particularly, there’s almost no funding for blue-sky thinking and very little support for researchers in the early stages of their careers. It’s little wonder the majority of scientists who cannot access funding leave science altogether, as they cannot sustain themselves and or their research. Every year in the UK there’s a huge loss of scientific knowledge and expertise: it’s a silent brain-drain. Dr Deepika Kassen Co-Founder, FutSci
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Co-founder Dr Perera says, “This is what FutSci is built for. With FutSci, we will engage the public in helping to fund basic research, such as pilot projects that could then go on to receive grants, and research into rare diseases that may have affected them or their friends and family, and we’ll give them a say in choosing the research that’s important to them. FutSci will enable donors to choose the specific projects they wish to fund and to engage directly in dialogue with the scientists and researchers they’re supporting via the platform.”
Further benefits of FutSci are its engagement with schools and encouragement of young people to develop their interests in science, coupled with a News and Views section to provide up-to-date reviews of current trends in life science research and scientific advancements, providing information on the typical process, costs and people involved.
Dr Kassen says, “We want to foster public engagement in bioscience and biomedical research and to encourage young people to consider a science career. Scientists can be approached by schools to get a true picture of what it’s like to study for a science degree, what happens in a lab, the different kinds of science available and also what doors can be opened by having a science degree, with an emphasis on promoting and retaining women in science.”
www.FutSci.com
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