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Beat the odds.

The Welsh never say never. Consider, for example, Ruskinn Life Sciences Ltd. They've developed a technology that helps maintain the optimal atmosphere for embryonic incubation. Which means couples trying in-vitro fertilisation have a better chance of success. That’s Wales, where passion and ingenuity combine to overcome the odds and accomplish what was once inconceivable. No wonder 500 companies from around the world have investments here. They know Wales has the right atmosphere for growth. And their chances of success are increased, too.

Gary Knott Group Technical Director Ruskinn Life Sciences Ltd.

projects

4 Trade Across

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the Pond Doing business successfully in the world-leading US healthcare market

Trade with the USA is something of a holy grail for British health technology companies. What draws them is not only the size and wealth of this market, but its proverbial appetite for innovation. This is a country that’s proven eager to work with the newest and most challenging developments in the sector. Our lead article is written for every UK company that wants to work with this American market. Inventors and manufacturers who want to make the best of the opportunities it offers have to understand what they’re working with. That means knowing what they don’t have, what they need to have, and how to go about sourcing it. We don’t provide an encyclopaedia – but we do give you a concise summary from people at the sharp end as to what works, what doesn’t, and what to look out for. The theme running through many of our other articles is one that is becoming more and more insistent not only in healthcare, but in political and social forecasting. The UK’s ageing population is a demographic shared with developed countries worldwide. You’ll find in this issue examples that demonstrate how health technology can tackle this most intractable of issues. Its potential is vast and already, there is evidence as to how it could revolutionise old age for us all.

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Coralie Palmer Editor

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+ 44 (0) 1443 845500 from overseas locations

Prizewinning easy-to-use drinking vessel

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A True Measure Determining obesity accurately

products 23

Giving a Hand New high-dexterity artificial hand

12 Health on the Home Front Moving healthcare from hospital to home

comment 16

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Limits on stem cell patenting

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Crossing the Borders Changes in Europe-wide patenting

Blood Will Tell Blood flow assessment device

in brief 28

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In Touch Communications system for the severely disabled

Unstemming Innovation

Prizewinners… Mixing it… Debugging… Timesavers … Best Foot Forward… Health Injections

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Great moments in medicine

The Medilink UK Review

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Trade Across the Pond Coralie Palmer looks at key aspects of the US healthcare market, from successfully breaking into it to building long-term success

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For health technology SMEs, trade with the US is one of the critical markers for success. With an annual expenditure on healthcare of some $2 trillion, the country accounts for approximately half of all healthcare spending worldwide.

to have a faster adoption rate in the US than in the UK, where the market is dominated by an NHS still grappling with an acknowledged conservatism in its response to innovation1. It’s this potent combination of size and responsiveness that makes the American market such a magnet for British SMEs.

Equally important is AmericaÕs recognised receptiveness to new technologies. Innovative products tend

In addition, the US is of course an English-speaking market – a positive

factor that can be misleading. Oscar Wilde’s description of Britain and America as ‘two countries divided by a common language’ is nowhere so applicable as in the realm of health technology. Vast differences are at work here: US regulatory, provision and purchasing systems bear little resemblance to those in the UK. Less obvious, but equally powerful, are cultural differences affecting custom and habit, values and expectations. At

‘Personal contacts remain a dominant factor in successful strategies’

the same time, there are influential factors common to the healthcare environments of both countries. The complexity of this mix can derail the most committed British SME, should it fail to do its homework. As a British consultant based in the US, James Wason sees the view from both sides: he works for the Maelor Group, which helps medical device companies bring their products to market. ‘I think the NHS background tends to give UK companies a skewed view of medicine in the US,’ James observed. ‘For example, most US hospitals are privately owned or non-profit organisations. But people who pay for healthcare don’t pay for beds: they pay for coverage. If you have an appendectomy and go into hospital, that is paid for as a set amount whether you’re in hospital for one day or 10 days.’

This factor has driven one of the biggest changes in US healthcare in the last decade or so: the move of surgical procedures from hospitals to centres for day surgery. These can now undertake even the most complex procedures, such as spinal surgery which 10-15 years ago would have demanded a two-week hospital stay. The UK has seen a comparable drive to move healthcare out of hospital-based secondary care into the primary care environment: as in the US, the drivers have been the advance of technology, together with an associated reduction in costs. So despite a radically different provision structure, both the US and the UK are working to move elements of healthcare out of the hospital environment, and British SMEs wanting

to export to the US need to consider the effect of this trend on their product’s place in the American marketplace. This is just one example of how the differences and similarities of these two markets have strategic implications that must be properly understood for a successful expansion into the US. US regulatory and reimbursement systems are the clearest examples of structural differences that demand careful management by British SMEs. As part of the US Food and Drug Administration (FDA), the FDA Center for Devices and Radiological Health (CDRH) is responsible for the regulation of devices in the US. It administers the 510(K) process that enables companies to market a device in the US by demonstrating its equivalence with one that has already been cleared. Despite widespread familiarity with 510(K) in the UK ☞

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device sector, a UK Trade & Industry (UKTI) summary report on US trade issues for device companies2 describes how SMEs can still experience difficulties or delays because of a poorly prepared submission. UKTI urges companies to make fullest possible use of freely available resources – beginning with CDRH’s own website – to ensure they include the right material, organised in the right way.

The report also points out that 510(K) clearance does not automatically mean – as SMEs sometimes assume – that the device is covered for reimbursement in the American Medicare programme. The Centers for Medicare and Medicaid Services (CMS) administer policies for coverage, coding and payment that vary depending on the type of provider. Essentially, hospitalbased treatment is reimbursed

according to Diagnostic Rate-related Group (DRG), as a global cost that includes bed/surgical time, drugs and devices; whereas treatment outside the hospital environment is reimbursed according to a given procedure code. Reimbursement is a notoriously complex subject and experts stress that the earlier it is addressed the better, particularly where SMEs with innovative

devices are concerned. If for example there’s no existing procedure code for your product, it can take up to two and a half years to get a new one allocated. Companies can go straight to the horse’s mouth and approach CMS staff for advice directly: they do not need FDA approval or 510(K) clearance before discussing issues around a particular device.

Preparing the Ground: Michelson Diagnostics researchers as opinion-leaders who can speak for the product, but will almost certainly be selling via an intermediary rather than directly. ‘We’re aware that big distributors or agents don’t necessarily work that well for innovative products that need to be pushed,’ John went on. ‘And a large group can tend to create a gap between customer and supplier at a stage when quality customer feedback is important. But we’ll need to engage in some kind of partnership, perhaps with a company that already sells instruments to hospitals. We have already attracted interest from some candidate partners, and with clinical approvals we’ll be able to develop these partnerships.’

New to the prospect of American expansion is Michelson Diagnostics, based in Kent. The company has developed a unique optical imaging technology, Multi-Beam Optical Coherence Tomography (OCT), that provides crystal-clear images of subsurface microstructure in both hard and soft tissue. The technology is primarily targeted at cancer diagnosis and treatment and Michelson’s Scientific Advisory Board includes two of the UK’s leading cancer surgeons. The company began selling its first product, the EX1301 OCT Microscope, in early 2008 and will soon be launching hand-held OCT scanners with equivalent performance. Michelson is planning for export to the US as a key part of its growth strategy: ‘We’re concentrating on the US,’ said Chief 6

Executive Jon Holmes, ‘because of their openness to innovative technologies, particularly in healthcare.’ The company is partway through an extremely thorough preparation for this move, and has made extensive use of UKTI programmes. Factfinding and exhibition missions were supported by the UKTI ‘Passport to Export’ and Export Marketing Research Scheme (EMRS), while its Overseas Market Introductory Service facilitated a targeted study on the US East Coast.

looking for new tools to test the performance of their own products. ‘These markets are led by conferences and workshops and word of mouth,’ said Jon. ‘You have to build up relationships, find out what people are interested in and engage on that level, and then they’re open to working with you. One example is that these groups need to produce high-quality publications for both status and funding, and we can demonstrate how our product will help them achieve that.’

Prior to their product being approved for use in the clinical environment in mid-2009, Michelson currently targets two particular segments of the research community: academics who work with clinicians in developing new cancer-related techniques, and commercial research laboratories

Once clinical approval is confirmed, Michelson will be building on this foundation to extend their strategy in a new direction on both sides of the Atlantic: ‘In that context it will be hospitals buying the equipment rather than scientists,’ said Jon. The company has established some key

The company is also bearing in mind the shift towards care outside the hospital. ‘Because of its size and cost, our instrument is more likely to suit a hospital rather than a GP environment,’ said Jon. ‘But now there are services offering scanning in a mobile clinic as part of a fully wrapped-up disease management system from screening to treatment. This kind of approach will open up diagnostic imaging to a larger target market, and our business model will become more about providing services than selling machines.’

Jon Holmes Chief Executive Michelson Diagnostics 11A Grays Farm Production Village Grays Farm Road, Orpington Kent BR5 3BD Tel: 0208 308 1695 Web: www.md-ltd.co.uk

This is definitely an area where expert advice is at a premium, and the right specialist advice can be well worth paying for. ‘It is absolutely essential,’ said James Wason, ‘to understand all the aspects of your product’s position in the market: where and how it’s going to be used, the specific benefits it offers and your evidence for that. Because then you can get to grips with the real economics of the transaction.’ Once companies define a product’s specific advantages and how it will be paid for, they can calculate whether the given reimbursement enables purchasers to make the desired return on what they will be spending. This cost/value calculation is at the heart of a successful engagement with the US reimbursement system. ‘You have to quantify how your product improves the relevant outcome,’ James continued. ‘Does it make a procedure safer? Simpler? Cheaper? More clinically effective? If you can make a clear, properly costed case for a better outcome then there’s an opportunity for you. But you have to make that argument in real terms.’ Interestingly, this is another influential factor paralleled by developments in the UK medical sector. In the context of the NHS market, it is now increasingly being acknowledged that for a device to be properly evaluated, it should be assessed not just in terms of initial cost, but of its lifetime impact over service delivery [see MLUK Review No1]: the technology’s interactions with staff numbers and time, the use of space, the movement of patients and equipment. Suppliers who can demonstrate this cost/benefit analysis substantially strengthen their case for purchase. As in the UK, this trend in the American market looks to be a longterm feature. The UKTI report notes that CMS intends in future to link payment specifically to the value of care provided: ‘This transformation will shift Medicare away from reimbursing providers based solely on volume of services and create appropriate incentives to reward healthcare providers for supplying high-quality care.’ So again, despite profound differences in the structure of healthcare provision, these two markets share an unexpected common factor. For UK SMEs, it reveals the strategic importance of quantifying the benefits

of their products in a specific healthcare environment, whether that’s at home or in the US. Aside from these specialised structural hurdles, the nuts-and-bolts reality of marketing within the US exhibits the same disorientating combination of the unknown and familiar. The sheer size of the US is such that not even its own businesses see the country as a single marketplace. Rather, it’s a jigsaw of regional interlinking markets, though even these cover vast distances by British standards. Yet at the same time, this is a country which puts a premium on working faceto-face at all levels: at last year’s Advamed conference, MediWales’s Manager Gwyn Tudor was told by a top US venture capitalist that investors like himself still want to be within driving distance of their investments (even if that’s an eight-hour drive). Consequently, one of the commonest mistakes UK companies make is to underestimate the time and commitment needed to develop personalised contacts in their US markets. ‘It’s not enough,’ said Gwyn, ‘to sign up an agent, head back to the UK and ring up six months later wanting to know the sales figures. You have to put in the hours to build and maintain a network of relationships in person, on the ground.’ This is true right from the exploratory stage of marketing development, and international conferences can provide ideal opportunities for face-to-face contact. Gwyn points out however the importance of choosing the right conference: ‘Medtrade in Atlanta seems to be sales rep country,’ he observed, ‘where you’re likely to find Americans buying from each other. Medica is more of a mix, though CEOs tend to guard their access. Advamed seems open to exchange at senior level – there’s a range of seminars from the basic to the specialised, and CEOs are freely accessible at those debates. So there I think participants could get an understanding from the centre outwards, through direct contact.’ Throughout the marketing continuum, the consensus is that personal contacts remain a dominant factor in successful strategies. ‘With innovation,‘ said James Wason, ‘the drivers in the US ☞

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Staying Ahead: Owen Mumford For Oxfordshire-based Owen Mumford, the US has been a key market in its international operations since 1991. Their two core product ranges – capillary blood sampling and drug delivery – are both evenly split between own-brand and OEM manufacturing, all of which is done in the UK. In the last five years the US market has accounted for between 30% and 45% of the company’s turnover, and last year made up 41% of its overseas sales. ‘We want to maximise that potential,’ said International Sales and Marketing Director Adam Mumford, ‘and our focus is on striking a balance between own-brand and OEM products, and between the clinical and retail markets.’ Initially the company targeted the US clinical market with its own products. Once the Owen Mumford brand became firmly embedded, their growing credibility exerted a pull that brought a steady expansion of both the retail market and the OEM operations. ‘We hold our OEM partners very dear to us,’ said Adam, ‘because these are some of the world’s major diagnostic and pharma companies and to be a supplier consolidates our credibility. Then as opportunities have arisen in retail we have developed a specific retail team to address the activities that succeed in that market.’ The Owen Mumford brand leads with quality and safety, particularly in their ‘physician preference’ category of products. Chief among these is the Unistik range of safety lancets, used in the US for capillary blood sampling in both the hospital and the MD surgery. ‘The US is famously litigious,’ said Adam, ‘and it has led the international

healthcare business are the clinical specialists: orthopaedic surgeons, cardiologists, gastroenenterologists, ophthamologists and the like. The big players – J&J, Medtronic – all have a rapport with these physicians. So if you’re a British SME, you really have to forge a relationship with your specialist end-user – someone who has “domain experience” in the right area, who can help you think through what you’re doing and how you’re going about it.’ Once more there are direct parallels with the UK health technology market. Innovative SMEs who successfully market to the NHS tend to prioritise the building of trusted working 8

and is a base for clinical and retail marketing specialists, quality assurance and customer service: ‘The US expects full-on service support,’ Adam confirmed. The US base also houses a packaging operation for the ‘private label’ business, which repackages goods as a designated brand according to demand.

market in terms of safe practices in this area.’ The Unistik targets that precisely, having a number of patented features whose benefits are easily demonstrable to a physician. Even with the company’s more commodity-based products, the strategy is to make small, incremental developments which add value, and which keep them distinctive. Maintaining that differentiation calls for carefully focused, responsive marketing. ‘There are key opinion-leaders and healthcare professionals who support product acceptance,’ said Adam, ‘and you have to build those relationships.’ He sees a sales team skilled in working through personal contact as vital to keeping ahead of market trends: ‘I like to think we are very, very close to the market,’ he went on. ‘If you’re not, then you won’t understand what the market is calling for, and you won’t have

relationships with health professionals, and develop appropriate products through consultation with them. There will typically be a highly skilled sales team at work whose sourcing of clinical champions is key, and this is very much a sustained process. What’s clear is that whether in the US or the UK, the medium for this activity is the irreplaceable graft of getting out there and talking to the right people, in the right way, over the long term: there is simply no short-circuiting this vital – and personalised – process. Distribution in the US, on the other hand, is a much more variegated territory than in the UK: national

the tools for developing the next generation of products to meet where that market is going.’ The complexities of reimbursement have their own dynamics in terms of market sensitivity. ‘Knowing about that is part of sales expertise,’ said Adam, ‘but we also employ reimbursement specialists on a contract basis. They’re people who live and breathe this activity, and who can find shortcuts through the complications.’ For distribution Owen Mumford again use a beltand-braces approach, using large wholesalers with nationwide reach to distribute products that may well have gained targeted backing through their own salespeople. The company now has an office and operational facility in Atlanta that oversees sales staff dispersed according to region,

distributors, wholesalers, dealers, agents and group purchasing organisations (GPOs) are just some of the stakeholders involved. Experts are unanimous about the need for companies to explore all the alternatives thoroughly before committing to a deal. This is particularly the case where innovative products are concerned: the UKTI report notes that these generally are not best served by a single large distribution company, and warns against choosing this as an easy option – an all too common error. Gwyn Tudor concurs: ‘What often happens,’ he said, ‘is that companies sign up too early to the wrong kind of deal: perhaps an

This territorial base will be important in staying abreast of the changes that Adam sees ahead. ‘As some of our markets mature,’ he said, ‘we can expect increased competition, so we need to pursue diversification and to keep innovating in our existing ranges. At the same time our very important OEM partners are constantly evolving, and we need to develop our technology and capabilities to match or exceed their expectations. So we need to keep our people very close to what’s happening in those markets to stay ahead of the game.’

Adam Mumford International Sales and Marketing Director Owen Mumford Ltd Brook Hill, Woodstock Oxford OX20 1TU Tel: 01993 812021 Fax: 01993 813466 Email: info@owenmumford.net Web: www.owenmumford.com

exclusive agreement with a distributor that won’t push the product, or with an agent that’s already selling a competitor’s product, or with partners who don’t have the market access they implied at an early stage.’ Equally distinctive is the high profile of proactive customer service in the US. ‘Companies that are successful and put down a footprint here,’ said James Wason, ‘clearly understand the importance of this. You have to provide well-run customer support that sorts out servicing and repairs,

problems and queries, that can take care of warranties – the full range of services.’ It also has to be quick to respond: ‘Americans in general,’ James pointed out, ‘are impatient people.’ This cultural factor is reinforced by a model of healthcare that makes Americans far more likely than their British equivalents to feel like paying customers whose demands must be met. Provided therefore that their preparation is rigorous, UK companies are well equipped to meet the particular challenges of the American market. There are not only great differences but unexpected similarities in the health technology sectors of the two countries. Success depends on thoroughly understanding how these factors work and turning them to strategic advantage, and companies have to be prepared to invest time and money in this process. UKTI has a number of programmes to assist businesses in researching and developing the American market, and part of the first of our two case studies describes how these have helped an SME with an innovative product to prepare a productive strategy. Companies new to US trading should actively seek help, which is more available than many of them realise. Grants and funding can be sourced not only from the UK but also from US States and even beyond. ‘One tip from Advamed,’ said Gwyn Tudor, ‘is that Ontario in Canada is within driving distance of the largest US medtech centres and is currently offering big tax credits, grants and a government venture capital fund.’ The most obvious hurdle is the complexity of regulatory and reimbursement systems, but the organisations that administer them are keen to assist rather than obstruct right from the early exploratory stages. Specialist consultants can be invaluable, but much essential information is easily accessible in the first instance.

contact. The targeted, personalised working relationships that underpin successful marketing in the UK health technology sector turn out to be just as applicable in the US. This is as true for companies with a long-standing US market presence as it is for those new to the game, and one aspect of our second case study shows how playing to this strength helps an experienced British manufacturer to maintain its strategic advantage in the US. Looking ahead, the shift of healthcare procedures away from the hospital environment looks likely to be a longterm and probably world-wide phenomenon. Meanwhile for America’s newly inaugurated President, healthcare reform is a major priority that will inevitably bring structural changes in its wake. Whatever those might be, the principles we’ve outlined in this brief overview will continue to provide effective handholds in a demanding but highly rewarding market.

Dr James Wason USA Market Consultant The Maelor Group Email: jwason@maelor-group.com Web: www.maelor-group.com Anne Avidon USA Lead Officer - Healthcare UKTI Email: anne.avidon@fco.gov.uk Web: uktradeinvestusa.com Gwyn Tudor Forum Manager MediWales Tel: 029 2047 3456 Email: gwyn.tudor@mediwales.com Web: www.mediwales.com

Perhaps the most surprising (and encouraging) common factor between the British and American markets is the influential part played by face-to-face

1 Cooksey, D, A Review of UK Health Research Funding, December 2006 2 Avidon, A, Entering the US Health Care Market: what medical device manufacturers need to know, UKTI 2007

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Health on the Home Front Telecare and telehealth are becoming vital technologies in managing the healthcare of an ageing UK population. The UK is getting older. A third of the population are now aged 50 and over: of these, more than 12 million people are over 65. Increased longevity is the natural result of improved living standards and medical care – but a long life does not necessarily mean a healthy one. Help the Aged reports that 38% of those aged between 65 and 74, and half of those aged 75 and over, live with a limiting longstanding illness. This demographic profile carries an inevitable burden for national healthcare. In 2004 (the latest figures available) over 40% of all NHS spend was directed towards care of the elderly.

Telehealth technology therefore offers a ‘win-win’ approach to improving healthcare and one that is explicitly supported at government level. Since its 2005 policy document, ‘Building Telecare in England’, the government has repeatedly reaffirmed its commitment to expanding telehealth services. At the same time, there is growing investment interest in an area

of health technology dominated by SMEs working across a wide variety of disciplines, including software, communications, data, hardware and security. The technology has moved a long way in the past 20 years, from the simple alarms of the early days to the sophisticated systems now available to care for multiple, chronic medical conditions. As part of that evolution, many experts are now increasingly distinguishing between telecare and telehealth. Telecare is broadly concerned with monitoring/adapting the home environment to support wellbeing, in the form of ‘assisted living technologies’. Telehealth, on the other hand, focuses specifically on the monitoring and care of individuals’ physical health and their particular disease conditions.

set-up also includes a simulated GP surgery showing this medical data being directly monitored.

Through its i-Health (intelligentHealth) initiative, Medilink West Midlands supplies practical evidence of how both can be implemented at home to maximum effect. The group has brought together some 800 companies in the region with an interest in these areas, and with their input has created two i-Health demonstrator units that show these technologies at work.

The second unit, the i-Home, shows how assisted living technologies can be incorporated into a conventional Victorian terraced house. Core functions such as heating, lighting and water supply are automated so as to respond to the resident’s needs, while key design elements in the fabric of the house assist access and mobility and prevent common accidents. The unit has proven that the structure of traditional buildings in no way inhibits the technologies that can be used.

One unit is a ground floor flat, illustrating the breadth of technology currently available. It includes devices that monitor environmental aspects from occupancy to safety to temperature, and others that support daily activities such as cooking and shopping. It also incorporates two specifically telehealth systems for remote monitoring and diagnostics, which collect essential medical data and forward it to a supporting clinician: the

The range of technologies implemented in both units is significant in itself. Both telecare and telehealth have grown in a piecemeal fashion over the years, led by a variety of businesses adopting whatever technology platform best fits the task. Consequently the compatibility or ‘connectivity’ of multiple different devices remains a chancy business. In developing the iHealth units as active home environments, the initiative required

participating companies to think through in detail how their technologies would work alongside others. Equally importantly, the scheme enables potential end-users to get a realistic sense of how, in practical terms, they would experience these multiple technologies in their daily lives. While the emergence of specifically telehealth applications has been driven by technological development, the technology itself must be led by clinical need to deliver real benefits. That priority was designed into the newest product from Safe Patient Systems Ltd, which originated in the research and development function at the Heart of England NHS Foundation Trust. Its ‘Safe Mobile Care’ system was developed by a team of clinicians led by David Morgan, a consultant surgeon at Heartlands Hospital and a surgical advisor to the National Patient Safety Agency between 2001 and 2006. Safe Mobile Care is a remote monitoring and prescribing system for patients with chronic conditions. ☞

PHOTOGRAPHS: HEALTH INFORMATION RESEARCH UNIT, INSTITUTE OF LIFE SCIENCE, SWANSEA UNIVERSITY

This is the context that has seen a dramatic growth in the use of telehealth technology to support the

care of people with chronic conditions. It is part of a shift in healthcare from hospital to home that not only reduces costs for an already stretched NHS, but improves the quality of life for the people being treated. Survey after survey has confirmed that people with these conditions overwhelmingly prefer the option of home-based care to that of repeated hospital visits, intermittent hospital stays, or long-term residence in a care home.

These technologies are complementary, and together they can dramatically affect the ability of elderly, disabled or vulnerable people to live and be cared for in their own homes.

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So far, so comparable with many other technologies: but a distinguishing feature is its exceptional versatility. ‘Our Safe Mobile Care package has been developed around healthcare issues,’ said the company’s chief operating officer Mark Doorbar. ‘We recognised that it’s important for any device to be able to monitor a wide range of longterm conditions, not just one or two.’

all the relevant telehealth elements into a customised package, and now provides this integrated service for Trusts in England, Wales and Scotland. ‘We consider all the different factors,’ said Director David Muxworthy. ‘That includes the targeted patients, the desired outcomes, the liaison with clinical staff, and the appropriate

This is precisely what the system offers, and for many patients at a time. Clinicians set the necessary monitoring profile either by selecting a standard ‘template’ or creating a custom one, and templates are offered for a dozen particular conditions from arthritis to diabetes, cardiac arrhythmias to chronic obstructive pulmonary disease. Bespoke web-based software then allows the clinician to tailor each profile to the individual patient’s needs, if necessary for multiple conditions. The same care has been given to the design of the patient interface, a simple and intuitive device based around a standard mobile phone. When prompted, patients just follow the menu-led commands and the results are automatically sent to the clinician. ‘Clinicians can respond quickly to specific problems,’ said Mark, ‘and they’re alerted to any worrying trends.’ And by using a mobile phone device, it has been easy to incorporate alarms to remind patients about their regular tasks, such as taking medication or a blood pressure reading. ‘Patients like it,’ Mark went on, ‘because it’s easy to use and completely mobile – it allows those with chronic conditions to enjoy greater freedom.’ The web-based system means that patient data is secure but can be accessed by clinicians in different locations, whether that be a GP surgery, hospital or social services unit. This relieves the burden of constant appointments for people whose conditions frequently make travel difficult, while for providers, it makes more appointment slots available for patients where attendance is essential. This is particularly important in relation to hospitals, where the impact of telehealth can significantly reduce the costs of secondary care. Another company offers healthcare providers not a product, but a service model for managing telehealth: one that shares the same emphasis on meeting the needs of both provider and patient. Home TeleHealth (HTL) have developed an approach that integrates 14

12-week period is up and the patient is stabilised, the technology is moved onto another newly discharged patient. Equally importantly, HTL train these patients in the use of their equipment, ensuring they are comfortable and confident with it. ‘These patients have multiple co-morbidities,’ said David, ‘and they’re back at home often feeling isolated and anxious. So this system gives them the tools to understand their condition, and keeps them supported.’ The service has been notably successful, reducing hospital admissions, bed days and length of stay, as well as GP visits; while at the same time, patients felt their quality of life was improved. HTL is now monitoring around 400 patients across two Northern Ireland Trusts for COPD, coronary heart disease or diabetes. The company is shortly to tender for a full managed service covering all five Trusts in Northern Ireland, for a total of 5000 patients.

technology.’ HTL can then either identify best-of-breed technology or work with the client’s own, and provide the requisite level of project management and technical support so that the right information is routed directly to clinical staff. Meanwhile in Northern Ireland, HTL is delivering its newer, ‘fully managed service’ model for the South East Trust (SET). This project implements a disease management programme for a rolling total of 22 high-risk patients with Chronic Obstructive Pulmonary Disease (COPD) for 12 weeks after their discharge from hospital, with the aim of stabilising their condition and reducing the rate of re-admission. SET however wanted a service that would free up its own clinical staff from routine data review. So rather than the monitoring information going straight to the Trust’s staff, it is routed via a dedicated, nurse-led clinical call centre – the first of its kind in the country. ‘It’s our nurses at the centre who do the monitoring,’ David explained. ‘That’s done to agreed protocols, and if a patient’s condition begins to deteriorate, it’s then that they will be referred to the Trust’s own clinical staff.’ HTL also provide the telemonitoring equipment, which they install, clean, maintain and de-commission: after the

As the initiatives described here illustrate, the positive impact on costs, care and quality of life puts these technologies at the heart of any strategy for long-term management of chronic conditions, and of planned healthcare for an ageing population. Equally importantly, all of these approaches show how the rapid evolution of both telecare and telehealth can be developed into models led by clinical need and patient welfare.

Medilink West Midlands 4 Greenfield Crescent, Edgbaston, Birmingham West Midlands, UK B15 3BE Tel: 0121 452 5630 Fax: 0121 454 2325 Web: www.medilinkwm.co.uk Safe Patient Systems Limited Lincoln House Birmingham Heartlands Hospital Bordesley Green East B9 5SS Tel: 0121 4241598 Email: info@safepatientsystems.com Web: safepatientsystems.com

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Home Telehealth Limited Saint Line House Mount Stuart Square Cardiff CF10 5LR Tel: 029 2044 4795 Fax: 029 2044 4232 Mobile: 07876 712021 Web: www.hometelehealthltd.co.uk

Distributor search & introduction Market research Commercial planning & implementation Regulatory certification (including CE and FDA) Statutory body liaison (PPA, MHRA etc) Professional and political lobbying (ABPI, NAPC, DoH, BMA etc) Clinical pilot user trials Financial & legal planning

In the UK health market, UK Healthgateway ticks all the right boxes. Contact us now.

Tel: +44 (0)207 664 8711 Email: jon@ukhealthgateway.com www.ukhealthgateway.com


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COMMENT

Unstemming Innovation

By Helen Brooke

Stem cell research is of vital importance in developing treatments for a wide variety of conditions and diseases, including Parkinson’s disease, spinal cord injuries and cancer.

Crossing the Borders At the core of the European patent system is the principle that a single patent application covers multiple European states, and can be made centrally in a single language (English, French or German) before a single patent office, the European Patent Office (EPO). This centralisation removes the wasteful and costly duplication that would be involved with parallel procedures in multiple countries. There have however remained limitations to the centralising principle, although efforts are persistently being made to ease or remove them. Chiefly they concern

The restricted potential of adult stem cells has in recent years shifted the focus of such research – and therefore of innovation – in the direction of embryonic stem cells. After years of social and scientific uncertainty surrounding inventions involving ‘unethical’ technologies, Biotechnology Directive 98/44/EC in Europe was adopted in 1998. This excluded some biotechnology inventions from patentability, and among them were uses of human embryos for industrial or commercial purposes. In November 2008 the European Patent Office published its first decision (G0002/06) concerning the patentability of inventions using human embryonic stem cells. This landmark decision involved a European patent application filed by Wisconsin Alumni Research Foundation (WARF) in 1998, concerning a cell culture of primate embryonic stem cells. These cells could be maintained – on a fibroblast feed layer – in an undifferentiated state, while retaining their ability to differentiate into a number of different tissue types. There was 16

however only one method described for making the cells, which was by using a pre-implantation human embryo. This WARF European patent application was refused in 2004. The claimed invention was not actually directed towards the use of human embryos: nevertheless, the stem cells could not be considered separately from the method used to make them, because that method described no alternative to human embryos as a starting material. WARF appealed the decision but lost the appeal, and the previous refusal was upheld. This European decision contrasts with the US, where WARF has achieved granted patents. The apparent upshot of the decision is that if, at the time an application is filed, the destruction of human embryos is the only way to reach the claimed invention, then it seems the application is destined to fail. It will not be possible to circumvent the law in Europe through clever drafting of claims to exclude references to the use of human embryos.

So, where does this leave stem cell innovation in Europe? It seems that whilst embryonic stem cells might be the most promising prospect for developing future treatments, adult stem cell innovation could become more attractive to the innovator who is looking to protect the fruits of his labours in Europe. It may be that this factor indicates a possible new direction in stem cell research, but only time will tell. Helen Brooke Chartered Patent Attorney & European Patent Attorney Appleyard Lees Blackfriars House, Parsonage Manchester M3 2JA Tel: 0161 835 9655. Fax: 0161 835 9654 Email: helen.brooke@appleyardlees.com Web: www.appleyardlees.com

Translation requirements have now been eased. Before this, once a central application was granted it was still necessary to file translations into the languages of each of the countries in which the patent was to remain in force. With more than a dozen European languages the translation costs rapidly mounted up (particularly for biotechnology patents which are typically longer than average) and meant that applicants opted to forego protection in many countries. These difficulties have been reduced with the successful negotiation of the London Agreement, which came into force on 1 May 2008. In essence, this means that France, Germany, the UK, Switzerland, Liechtenstein, Luxembourg and Monaco have

By Tim Hewson

a granted European patent can be amended centrally with a single, relatively cheap and quick request filed at the EPO. Diplomatic efforts are still ongoing to establish a central court for litigation of European patents, but the consensus on this issue appears to be ‘don’t hold your breath’. Other options are still available. Although centralisation of the European patent system can result in significant cost savings, it does have drawbacks. Before grant you are stuck with the EPO - and whilst their examiners are usually highly skilled, the EPO is neither quick nor cheap. Granted European patents are also vulnerable to a central European opposition being filed against them by a third party. A successful opposition will knock your patent out in all EPO countries.

Applicants should therefore not overlook the fact that many national patent offices are still open for business in Europe. A sophisticated patent strategy should consider filing national applications in countries of major importance. The UK Intellectual Property Office is quicker and cheaper than the EPO. Germany also has a strong national patent office and an IP system that includes Utility Models. These are unexamined patent-like rights which can be brought to grant more quickly than full patents and can be useful when you are in a hurry to assert a granted right over an infringer. geographical scope; translation demands; and amendments made after patents have been granted. Each of these areas has seen improvement, but applicants should still be aware that a centralised application is not the only option. Geographically the area covered has been steadily expanded. A European patent application filed today automatically covers 35 countries: the EU, plus Switzerland, Liechtenstein, Turkey, Monaco, Iceland, Croatia, Norway and Macedonia. It is also possible to extend a European patent application to Albania, Bosnia & Herzegovina, FYR Macedonia and Serbia. This expansion may continue because the EU will require any prospective members to join the European patent system first.

completely dispensed with translation requirements and that the Netherlands, Denmark, Sweden, Croatia, Latvia, Slovenia and Iceland require translation of the claims only for patents granted in English. Nevertheless a number of important countries – including Italy and Spain – remain outside the London Agreement and continue to require a full translation. Post-grant amendments have been simplified. It is not uncommon for a patent owner to want to narrow the claims of their granted European patent, in order to avoid disclosing prior art that has newly come to light. Until recently such amendments had to be made before each individual patent office. Since December 2007, however,

A qualified patent attorney will be able to guide you through this complexity to make sure that you benefit from the cost savings that centralisation undoubtedly brings, without neglecting those national differences and peculiarities that can give you a strategic edge over your commercial rivals.

Tim Hewson European Patent Attorney Abel & Imray 23 Windsor Place Cardiff CF10 3BY Tel: 029 2034 7030 Email: tim.hewson@patentable.co.uk. Web: www.patentable.co.uk

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PROJECTS

Design on Tap A collaborative project to design a drinking vessel for elderly and disabled people is now at the product development stage, and offers an innovative model for encouraging new product design.

An adequate intake of water is fundamental to health, and even more so in old age. It is vitally important in conditions such as diabetes, ulcers and incontinence - all ailments that are prevalent in the elderly. And lowered thirst drive (well recognised as an age-associated problem) may result in falls and mental confusion that lead to hospitalisation. Dehydration is therefore a real threat in old age and this is all too true even in healthcare environments: often the cup is out of reach, empty or too difficult to lift, and busy nurses may be unable to monitor their patients’ fluid intake accurately. There are now moves at a national level to address hydration management. The National Patient Safety Agency (PASA) has identified it as a patient safety issue, and together with the Royal College of Nursing has developed an online advice kit for healthcare staff. The NHS Supply Chain has also stated its commitment to finding suitable products that ensure drinking water is ‘well presented’. Several fluid dispensers are already on the market that can remind patients to drink or monitor fluid intake, but each has its limitations in terms of patients’ and carers’ needs and wants. Two years ago Professor Roger Feneley of the BioMed Centre in Bristol wrote to the MediWales Review, publicly calling for manufacturers to tackle the problem. The Professor had helped found the Centre, established in 1998 to improve continence management for older and disabled people. His letter sparked interest not just from manufacturers but from academia, and a collaborative group coalesced 20

that included BioMed, Plymouth University, and Biplas Medical Ltd, a Welsh company with expertise in developing medical devices. All shared the desire to see on the market a product that encouraged safe, consistent, comfortable fluid intake without demanding the constant presence of a carer. The result was the BioMed competition, challenging students of 3D design to come up with a blueprint for a stylish, effective Drinks Dispenser for older and disabled people. It was open to all students from the South West and South Wales, with Biplas taking the winning design through to manufacture. BioMed itself set the competition’s criteria: the dispenser had to be not only easily usable by people with limited dexterity, but aesthetically attractive to them. It also had to monitor fluid intake, hold two litres when full and release varying amounts of water on demand. Last but not least, it had to be affordable.

Joining Roger Feneley on the judging panel were BioMed’s Director Adele Long and Richard Bedwell from BiPlas, along with Elizabeth Dymond, Trust Innovation Lead for North Bristol NHS Trust and Geoffrey Burston, Emeritus Consultant and senior lecturer in Geriatric Medicine. All were struck both by the high standard of the entries they received and the enthusiastic response of the students: Roger commented that many of them ‘became dedicated to the purpose of the project.’ It was clear from the presentations that much research and analysis had been focused on the end-users’ precise needs, with most students interviewing them directly either at care homes or through personal networks. One group took the opportunity to explore in detail how users could be involved in product design. Their entry was not the best in terms of the brief, but the judges declared it the one they would ‘most like to buy’. Against stiff competition, the ultimate winner was Rhys Thomas, a final-year Product Design student at

Swansea Metropolitan University, who took home the award (donated by the John James Bristol Foundation) of £1000. His design comprised a jug on a stand, holding a cup with a dispensing lever that operates a valve system. When the lever is lightly pressed – and the weight of the user’s hand alone will achieve this – water is released into the cup. A built-in sensor detects the jug’s fluid level: if this remains unchanged over a timed period, an audible and visual alarm activates, alerting the user to drink more. When empty, the vessel again sounds an alarm. Refilling can be done with the jug on or off its stand: the jug’s handle rotates so it can be lifted from the top, which requires little manual dexterity and places minimal stress on the wrist. Work is already underway on the next product development stage, and BioMed are carrying out a hydration study to define different types of users in a variety of settings. ‘We’re keen to move forward to a workable design and

pre-marketing stage,’ said Richard Bedwell. ‘We need the feedback of nurses, carers and users – this information will enable us to survey the marketplace, so we can identify interested parties to partner this project into production and sales.’

The BioMed Centre Bristol Urological Institute Southmead Hospital Bristol BS10 5NB Tel: 0117 959 5690 Fax: 0117 950 2229 Email: biomed@bui.ac.uk Web: www.biomedhtc.org.uk

Richard Bedwell Biplas Medical Ltd Units 3/4 Llantrisant Business Park Llantrisant Pontyclun Rhondda Cynon Taff CF72 8LF Tel: 01443 237654 Email: richard.bedwell@biplas.com Web: www.biplas.com

New Technologies in Healthcare 13th May 2009, Millennium Stadium, Cardiff

A conference and exhibition profiling the practical application of healthcare technologies Highlights: ●

An insightful programme highlighting key advances and practical applications of Radio frequency identification (RFID) and Micro and nanotechnology (MNT)

Technology showcase – What’s new in MNT and RFID technology

NHS Market access - The medical devices market in Wales & opportunities for suppliers

Brokerage opportunities with pre-arranged, one-to-one meetings to discuss potential collaboration projects and commercial opportunities

An exhibition and networking opportunity to share ideas and enhance your company profile

Centrally located at Cardiff’s Millennium Stadium. A short walk from Cardiff Central Station with good links from the M4

REGISTER ONLINE

Free delegate places. This unique event will appeal to anyone interested in learning about new, specialist technologies and products in the healthcare sector. The event will profile the practical application of new products to improve service delivery, patient safety and a variety of other medical advancements. REGISTER TO EXHIBIT

Free exhibition space. Register your business now to demonstrate and showcase your new products, new ideas or new technologies. Make connections and promote your business to health-sector professionals.

Register now at www.newtechnologyconference.co.uk ORGA NISED B Y:

IN ASSOCIATION WITH:

SPONSORS:

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PROJECTS

PRODUCTS

A True Measure

Giving a Hand

A new method of determining obesity promises a more effective way of diagnosing and managing this condition, which is increasingly becoming a worldwide problem.

Until recently a science fiction fantasy, a new lifelike ‘bionic’ hand is now available that is already changing the lives of amputees.

muscles. A cosmetic skin or ‘cosmesis’ gives the hand a lifelike appearance, allows free movement of the i-Limb’s fingers and rotating thumb, and provides a highly effective grip surface.

Developed by Scottish company Touch Bionics, the i-Limb looks and acts like a real human hand. The culmination of decades of research, it combines leading-edge mechanical engineering techniques and high-strength plastics to create a truly dextrous, realistic artificial hand.

The i-Limb operates through myoelectric sensors, which sit on the skin of the patient’s limb stump and pick up microvolt signals from the muscles just beneath. Translating the myoelectric signals into hand movements is a major part of the i-Limb Hand technology, because the control strategy varies from person to person. Since every individual has different residual muscles, the hand’s control system must be tailored so that it responds to the signals each person is capable of generating. Existing users of basic prosthetic hands are able to master the i-Limb within minutes.

There have long been concerns over the accuracy of the prevailing measure for obesity, the Body Mass Index or BMI. Calculated by dividing a person’s height squared by their weight, a measure of 25 to 29.9 is classified as overweight, while someone with a BMI over 30 is considered obese. This is at best only a crude indicator for health. Muscle weighs more than fat for example, so an Olympic athlete would have a higher BMI than a flabby person of the same height. And the location of body fat is important: when deposited around the trunk, it is a strong predictor of potentially fatal obesity-related conditions like diabetes and heart disease. Now a trial at Heartlands Hospital has been successfully completed using a new and more precise technique, the Body Volume Index or BVI. Using scanning technology, the BVI measure incorporates body shape, muscle mass and location of fat. The two-year Heartlands trial took place as part of the Body Benchmark Study, a major global research initiative to develop BVI as the long-term body measurement standard for healthcare. Launched in March 2007, the study will measure in total at least 20,000 volunteers in the UK, the US and Europe.

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The BVI technology was developed by Birmingham-based company Select Research, whose Managing Director, Richard Barnes, was also Project Director for the Heartlands trial. The BVI measurement technique is based around a 3D scanner that Select had already used to assess body shape and dimensions for the clothing industry. But for this new venture they needed to be able to calculate the volumes of individual body parts, so a computerbased system was devised with the help of experts from the IT Futures Centre (ITFC) at Wolverhampton University.

This newly refined technology was used in the Heartlands trial. Patients stand inside a 3D scanner that quickly creates a virtual model of a person’s shape, and the system then gives a computer analysis of both muscle mass and the location of fat within each segment of the body. The result is a far more effective assessment for obesity than BMI. Rower Ashley Granger, for example, is nineteen years old, 6ft 2ins tall and according to his BMI of 28 is borderline obese. But his BVI scan correctly showed that he carries very little fat and that his weight is largely down to muscle.

Unlike the usual claw-like device offered to amputees, which mimics the opening and closing of a thumb and forefinger, the i-Limb’s ‘fingers’ are all fully articulated: each individually powered digit moves and grips under the control of the patient’s mind and

Dr Asad Rahim, Consultant Endocrinologist at Heartlands and leader of the research team for the trial, sees many advantages in the new technique. ‘This is a far more sophisticated way of measuring obesity,’ he said, ‘particularly in signalling the danger of fat build-up in certain areas. It also allows us to track changes in body shape over time, whether this is associated with weight loss or weight gain.’ Participants in the Heartlands trial found that they were more motivated to lose weight as they saw images of their changing body shape over the trial period. With obesity predicted to cost the NHS £45 billion by 2050, BVI shows all the signs of being a highly effective tool for tracking levels of the condition and managing its treatment. Select has teamed up with the Mayo Clinic in Rochester, Minnesota, which specialises in cardiovascular disease, to undertake the next two-year phase of the research study. The BVI project will incorporate data from over 11,000 3D body scans of US Citizens to allow patients at Mayo to be measured against the US national average. Similar data from the UK is being used by UK researchers for population analysis and benchmarking BVI for Childhood Obesity is already underway.

The design is modular, with the i-Limb being a chassis for the five digits which contain their own batteries and motors. ‘There’s no electrical hard-wiring in there,’ said Hugh Gill, Touch Bionics’s director of technology and operations. ‘It’s all done with direct-contact cotter pins, which are spring-loaded. You can just screw in a new digit and it engages with the electrical contacts and away you go.’ This also means it is easy to repair: any of the fingers can simply be unscrewed and replaced, whereas traditional prosthetics that have to be returned to the manufacturer often mean leaving the patient without a hand for weeks. The i-Limb is already being used by more than 250 amputees worldwide. One of them is war veteran Sergeant Juan Arredondo, whose left hand was ☞

Select Research 42 Calthorpe Road Birmingham, B15 1TS Tel: 0870 727 1658 Email: info@select-research.com Web: www.selectresearch.com

Body Benchmark Study Web: www.bodybenchmark.org

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In Touch

severed at the wrist during a roadside bombing in Iraq in 2005. With his earlier prosthetic hand, Arredondo could only form a ‘C’ in a pinching movement. ‘That’s all it could do – just open and close,’ he said. ‘Now I can contract it as slowly or as fast as I want. I can pick up an egg without even thinking about it.’ Another i-Limb user is 18-year-old Kasey Edwards Monday from Florida who lost his hand to an alligator in June 2008. Kasey describes his new prosthetic hand, which replaces a golf glovecovered device that had to be rotated manually, as ‘awesome’. And the iLimb’s special attachments are enabling him to continue with his twin passions, hunting and fishing. The i-Limb project started life almost half a century ago in a research programme led by David Gow at the Princess Margaret Rose Hospital, Edinburgh, to develop prosthetic solutions for children affected by Thalidomide. In 1988, David and his 24

team began in earnest on electronic arms, including shoulders, wrists and hands. In early 2003, the company, initially called Touch EMAS (Edinburgh Modular Arm System) was spun out from the National Health System and in 2005 was renamed Touch Bionics. The i-Limb hand was launched in July 2007 and its impact has already won it the 2008 MacRobert Award, the UK’s most prestigious engineering prize. It has also been named one of the 50 Best Inventions for 2008 by TIME magazine, and is in the finalist group being considered for America’s 2009 Edison Best New Product Awards. ‘It has been a long journey for our technology,’ said the company’s Chief Executive Stuart Mead. ‘We have successfully transitioned from a research and development company to one that is now shipping and supporting product globally. We have always existed to change the lives of patients with severe injuries and

A new touch-based communication system fosters greater independence for spinal injury patients and other severely disabled people.

to control a whole range of simple but essential daily functions, from calling for assistance to turning lights off and on.

Spinal cord injury affects approximately 40,000 people in the UK, and many of them are faced with adjusting to permanent paralysis as a fact of their future lives. Rehabilitation for these individuals is lengthy and the adaptation it demands is radical: the simplest, most intuitive tasks become major challenges. The pioneering Sensagest system, developed by Bristol company Pure Ability, is designed to help patients through this difficult and traumatic process, and to support their daily lives in the long term.

Sensagest can be programmed to recognise broad hand gestures, such as a stroke or a tap, or entire hand movements. The system will also ‘learn’ to interpret the different levels of movement a patient is able to make: a simple shrug, for example, can be programmed as a call for assistance. The processing unit also includes a voice recording that confirms the requested action, as well as an audible alert and a small transmitter that is able to send messages to the pagers worn by nursing staff.

disabilities, and it is thrilling to feel that we are now able to accomplish that.’

Touch Bionics Unit 3 Ashwood Court Oakbank Park Way Livingston EH53 0TH Tel: 01506 438556 Fax: 0845 280 5169 Email: info@touchbionics.com Web: www.touchbionics.com

A typical problem is the need to call for assistance: the usual bedside call unit relies on the user having sufficient motor function to be able to depress a button – just the kind of action that can be impossible for severely disabled patients. So Sensagest is activated not by buttons, but by gestures that can easily be performed by people with minimal hand dexterity. The system includes a touch-sensitive pad about the size of a mouse mat, linked to a processing unit. The pad is able to respond to hand movements or gestures

‘Simplicity was the key,’ said Pure Ability’s CEO Ian Anderson. ‘I didn’t want something that relied on 20 different gestures in order to work. It needed to respond to touching or stroking movements, even when the patient wasn’t able to perform these movements smoothly. And it needed to be easy to use. For example, if you stroke from left to right it switches the TV on. Stroke up and it turns the volume up, stroke down and it turns it down, and so on. If you tap the system, it changes between different modes. It

takes minutes to learn and the audio feedback means patients know exactly what they are doing.’ Pure Ability has developed both the hardware and proprietary software that make up the Sensagest system, which is informed by direct experience of the problems involved. Ten years ago Ian was left paralysed from the chest down after a car accident. Although he himself later regained some use of his hands, when he took a PhD in mobile and wearable computing at Bristol University he saw the technology’s potential for helping patients with severely limited motor function. In 2006 Pure Ability Ltd was launched in an incubator unit of the SETsquared Partnership, an enterprise support collaboration between the Universities of Bath, Bristol, Southampton and Surrey. Within a year of the launch Sensagest had won two Medical Future Innovation Awards in the Bone and Joint Innovation category – one for Best Patient Independence Device, and the second as overall Best Product. With support from the university’s spinout team and the SETsquared Partnership, Pure Ability has been able to access expertise to help structure the business, find access to grants and funding, and see Sensagest through clinical trials ready for manufacture. Patients and nursing staff at the Midlands Centre for Spinal Injuries in Shropshire have been closely involved in developing the Sensagest system, which is already improving lives there. Pure Ability is in discussions with a number of potential partners interested in licensing the touch-sensitive technology, and with companies interested in manufacturing and distributing Sensagest.

Pure Ability Ltd University Gate East Park Row Bristol BS1 5UB Tel: 0117 915 1288 Fax: 0117 903 9001 Web: www.pureability.com

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Blood Will Tell An innovative device designed to measure the health of arteries could help early detection of common but life-threatening diseases. New from Loughborough company Dialog Devices, PADD uses the latest opto-electronic technology to ‘see’ below the surface of the skin and monitor the flow of blood to the lower limbs. The technique has the potential to reduce the impact of peripheral arterial disease (PAD), which affects one in four people over the age of fifty. By narrowing or blocking arteries outside the heart and brain, PAD reduces blood supply to the limbs and is implicated in a range of serious diseases. Poor blood flow to the legs in particular is a common complaint in cardiovascular disease and diabetes, and can lead to tissue damage, pain, infections and in extreme cases amputation. Patients suffering from PAD are at high risk of having a heart attack or stroke: without adequate treatment, 30% die within five years. Many of these deaths are preventable if PAD is diagnosed and treated. Originally a spin-out from Loughborough University, Dialog Devices has spent the past four years designing and developing the PADD technology, which provides the first fully-automated, non-invasive assessment of blood supply to the lower limb and foot. The cardiovascular system adapts as postural changes occur – there are large blood pressure changes in the feet, for example, as an individual rises from sitting down to standing up. The PADD technology tests the extent to which the cardiovascular system responds to this postural demand. If there is a weakness in this system, PADD will detect it before it becomes serious enough for the development of clinical symptoms. PADD offers significant advantages over the current method used to assess vascular health, the Ankle Brachial Pressure Index (ABPI). Skilled operators are needed for the ABPI, which is not only time-consuming but takes the patient into secondary care with all the associated costs. The PADD technology is specifically designed for primary care level, aimed 26

at nurses and healthcare assistants in GP surgeries. The test itself is simple and quick to conduct. Infrared light is passed through sensors attached to the patient’s foot, allowing computerized analysis of the movement of the arteries. The system collates and processes data for two test stages: firstly with the leg at rest, and then with the leg elevated. It provides an instant quantitative reading, and the process takes less than five minutes. The simplicity of this vascular diagnosis means that it could easily become part of a regular health check-up. Most obviously, it could help prevent heart disease and strokes. But it also offers a particularly useful tool for the routine assessment of diabetic complications. In the UK, 3% of the population have diabetes and 40% of hospital admissions for diabetics are related to disorders of the feet. Just as importantly, PADD could help reduce clinical complications by making early therapy possible: lifestyle modifications, better diet, and drug therapy can help to avoid surgical interventions. Dialog Devices has partnered for clinical trials with both the University of Leicester and the Royal Free Hospital in London. Its device has already been evaluated by the Department of Health

as part of the National Institute for Health Research (NIHR) Health Technology Devices Programme’s competitive grant process, with the company being awarded £400,000. The extensive two-year peer review process confirmed the health and economic benefits of introducing PADD into UK primary care, but the company sees early sales as more likely to come from the US where interest from commercial medical device partners is already evident: PADD was a runner-up in Santa Clara University’s Silicon Valley Boomer Business Plan Competition, which highlights products addressing the particular needs of the ‘baby boomer’ generation. In the last year it has also won both the East Midlands’ Lord Stafford Award for Innovation in Development and the Medilink East Midlands’ Innovation Award.

Dialog Devices Ltd Loughborough Innovation Centre Epinal Way Loughborough Leicestershire LE11 3EH Tel: 01509 222 411 Fax: 01509 222 411 Web: www.dialogdevices.co.uk


REVIEW

IN BRIEF

prizewinners

mixing it

Hull leads the way in Telehealth

Medilink UK Awards Ceremony 2009 11.30am-3pm, Monday 16th March Haberdashers’ Hall, London Headline Sponsor XIROS - www.xiros.eu.com Xiros works in collaboration with surgeons and medical device manufacturers to transform innovative ideas into minimally invasive medical textile implants.

Finalists Export Awards

Sponsor - UKTI

IDS Ltd

IDS manufacture a range of bone and skeletal assays Manufacturers of high tech diagnostic primary care products Design and manufacture products for heating and warming

Mediwatch UK Ltd Inditherm Innovation

Sponsor - Health Technologies KTN

Medalytix

Quality-assured, fixed cost grading services to retinal screening programmes Dedicated to pioneering a new generation of innovative but affordable surgical robots Specialise in the research, development and manufacture of high quality, immunodiagnostic assays

Prosurgics Freehand The Binding Site

Growth in Sector

Sponsor – BERR

Kingkraft Ltd

Moving and handling products for disabled persons Specialises in the design and manufacture of social alarms Flexible pharmaceutical development and drug manufacturing services

Tynetec Ltd Penn Pharma

Partnership with NHS Sponsor - NHS National Innovation Centre Neural Pathways Docobo

Home Telehealth

Start-Up Trio Healthcare Ltd Medalytix 4FX Healthcare Ltd 28

Flexible, individual programmes of rehabilitation EHealth community-based patient management and monitoring (telehealth) system Provision of managed services and telecare technology for remote health and social care monitoring Sponsor - NHS National Institute for Health Research Produce stoma, continence and wound care applications products Quality-assured, fixed cost grading services to retinal screening programmes A baby healthcare products company with an award winning infant nasal aspirator

Hull’s STREAM telehealth project has won first prize for IT Project Innovation at the Local Government Good Communications Awards 2008. The judges said that the project ‘lays a foundation for future delivery of services from both the Local Authority and their chosen partners.’ The system shows how Hull’s Community Care services are using telehealth and telecare to help elderly people continue living independently at home. Together with other key partners from the city, Hull City Council launched STREAM Independent Living as part of the city’s Stream TV project. Through a council-supplied, broadbandenabled digital set top box, older or vulnerable people can use their televisions to access community care services that are personalised for them. The project has recently agreed a key syndication deal with the NHS to deliver all of the NHS Choices website video content to STREAM users. The agreement has its roots in the close relationship the project has built up with the NHS/PCT locally and with the third sector: all have collaborated with healthcare staff throughout the city to produce local, health-related programming. The result is a health delivery system that will improve patient care while reducing costs. ‘We feel STREAM has huge potential to add to the way services are delivered,’ said Steve Fleming, the Council’s Group Manager Knowledge Economy. ‘At its heart this is the personalisation of services for citizens. Because Stream is a “learning” system it offers the opportunity to plan and commission services that are more effective for citizens and more efficient for service providers.’ Hull is also working with partners in the national DC10 Group, the group of Digital Challenge national finalists funded by the Department of Communities & Local Government, on how these new approaches can help tackle the national issue of an ageing population by using digital technology to promote the inclusion of elderly and vulnerable people.

To find out more about the Stream Project visit: www.streamonline.co.uk or www.hull.co.uk/healthcare

Business Meets Academia at KTP Businesses seeking to collaborate with UK universities can get direct support from the Health Technologies KTN under the Knowledge Transfer Partnership scheme. Projects should be defined that are of strategic importance to the business and can cover technical, marketing and business issues. The KTP scheme can deliver a KTP Associate to work closely with the business on the programme and also call on the support of the contributing research partner. NHS Trusts are already gaining benefit from the knowledge base they are engaging with: a range of projects are under way or are fully complete, involving companies from SMEs such as Optos and Salts Healthcare to global groups like Johnson & Johnson. One example is Vascutek Ltd, who sought a KTP to develop a new range of endovascular devices for the treatment of Abdominal Aortic Aneurysms (AAA). Novel manufacturing methods were needed for joining and materials processing, and the Health Technologies KTN made connection between TWI Ltd and Vascutek to explore a programme

The ‘Anaconda’ endovascular device of work. A KTP was established to explore rapid and automated manufacturing techniques leading to an approved automated process. The final goal is acceptance to the required specifications and development of quality control techniques, to enable automated production of the endovascular device at Vascutek. The KTP Associate for this project is Mr Arvind Patil (arvind.patil@twi.co.uk).

Further information on the KTP scheme (www.ktponline.org.uk) and assistance in finding partners and preparing proposals can be provided through the Health Technologies KTN (www.healthtechktn.com): contact Professor Mehdi Tavakoli (mehdi.tavakoli@twi.co.uk).

Qualifying Device The University of Bolton’s Centre for Materials Research & Innovation (CMRI) is offering an interdisciplinary MSc in Medical and Healthcare Devices (MHDs)

It is a leader in the UK – and is known internationally – for its research and applications development in the fields of biomedical sciences together with applied materials science and engineering.

The course is for graduates, scientists and technologists working in or towards a career in this sector. Students will develop an understanding of the properties of advanced materials and how they affect the design of MHDs, which will be explored in the context of human anatomy, physiology, disease and rehabilitation.

Students will study intelligent bioengineering systems and consider how smart materials, microelectronics and mechanical and IT knowledge are used in the development of MHDs, including novel biosensors. The course will also consider the principles that underlie the development and application of advanced materials, as well as the regulations, procedures, and ethical considerations that are applied to this sector.

The CMRI is a multidisciplinary centre in which research and innovative processes are conducted in collaboration with industry and other academic institutions.

The course is taught in six modules and also includes a research project, which

students will agree with their supervisor and undertake either at the university or the student’s workplace. Throughout their studies students will have opportunities to interact and collaborate with industrial partners, UK medical and dental schools and the NHS. Successful completion of the course can lead to Ph.D research degree programs for which scholarships are available to selected students.

For further information please contact Professor Martin Grootveld, Centre for Materials Research and Innovation the University of Bolton. Tel: 01204 903502 e-mail: mg6@bolton.ac.uk

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IN BRIEF

debugged Fast Test for Superbug Acolyte Biomedica has developed a rapid screening test for MRSA (Methicillin-resistant staphylococcus aureus) which reduces the time taken to diagnose the killer bug from days to just a few hours. Its BacLite test is proving to be a powerful weapon in the battle to reduce the spread of MRSA and is already being used both by NHS and private UK hospitals. The BacLite technology allows microbial detection and antibiotic sensitivity determination in two to five hours. The speed of testing means that hospitals can improve the management of infectious disease patients and reduce the costs associated with this infection. Acolyte Biomedica is a joint venture with Defence Science and Technology Laboratory (Dstl) at Porton Down. Part of the MOD, Dstl was set up by the government to transfer technological expertise and research to the commercial UK market. The joint venture specialises in developing rapid

microbiology test methods for use directly from a patient sample. Based at the Tetricus bioscience business incubator in Porton Down Science Park near Salisbury, Acolyte Biomedical is now part of global technology company 3M. The acquisition will help 3M to expand more quickly into the emerging market of infection prevention diagnostics, especially in Europe. Acolyte Biomedical is now using specially equipped laboratories at Tetricus to develop rapid screening tests for the other antibiotic-resistant hospital bugs including ESBL (Extendedspectrum Beta-Lactamases) and VRE (Vancomycin-resistant enterococci). Both cause urinary tract infections in the community as well as in hospitals, and VRE is common among long-stay patients. These infections are on the increase and new methods to combat them are badly needed. Acolyte Biomedica plans to launch new screening tests for ESBL and VRE once clinical trials are complete.

Inspired Against MRSA In response to the ever-increasing problem of bacterial resistance to conventional antibiotics, Exopack Advanced Coatings has developed the ‘Inspire’ PSA-coated polyurethane film that provides protection against bacteria, including MRSA. Inspire polyurethane film without PSA has the same antibacterial properties as the adhesive version. It is available as a material for coating or laminating to a variety of wound dressing components. Both materials maintain the mattness and low friction coefficient associated with the Inspire film portfolio. The polyurethane can be cast onto either a paper or film substrate to meet customer requirements. The incorporation of antibacterial material into both the upper and lower surface of the film ensures complete patient protection. Bacteria that may migrate onto the surface of the dressing will be killed: the underside of the dressing is protected by the antibacterial adhesive.

The products can be coloured to create a silver appearance and printed with either a logo or information to enhance the antibacterial message. Other products in the Inspire range include breathable foams, acrylate adhesives, clear polyurethane films and conductive media. Exopack Advanced Coatings, Wrexham Tel. 01978 660 241 Email: gwen.simms@exopack.com www.exopackadvancedcoatings.com

Clean Between the Sheets Cliniweave is a new fabric-based approach to tackling the spread of Hospital Acquired Infections (HAIs)such as MRSA and C difficile. It comprises an environmentally friendly bacteriocidal compound, already used in a range of household products, which can be added to fabrics to destroy harmful bugs that would otherwise proliferate in the fibres. This creates an elimination zone and breaks the chain of infection. Developed by Intelligent Fabric Technologies, Cliniweave has been tested at Imperial College, London. The results show that Cliniweave technology is over a thousand times more effective against bacteria associated with HAIs than other antimicrobial fabric technologies. As well as destroying MRSA and C. difficile, it is also effective against E. coli, Anthrax and SARS. The treatment can be incorporated within fabrics, plastics, papers and a host of other products. Cliniweave has already been applied to curtains and duvet covers for use in hospitals. These can be washed and sterilised as normal without compromising their bacteriocidal effects. The active compound, which breaks down bacterial cell walls, has been in use in other products for many years and is well proven, so the company is confident that there is little chance of bacterial resistance developing. Cliniweave is the latest in a range of ‘functional fabrics’ from Intelligent Fabric Technologies, and the company believes the Cliniweave technology could also be applied to paints and varnishes.

For further information please contact: George Costa Intelligent Fabric Technologies plc Tel: 01707 228 688 Email: info@ift-plc.co.uk 31


REVIEW

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best foot forward

time savers While you’re Waiting…

DON’T MISS YOUR GP

A brand new self-inflating precision cushion that can reduce the risks of Deep Vein Thrombosis (DVT) has recently made a big impact in the medical market, helping prevent further complications for patients during recovery.

Thanks to a new instant messaging system, patients waiting for appointments at the Oncology Ward of world-famous Addenbrooke’s hospital in Cambridge now have the latest information on tap. Designed and installed by Visual Planet, the system gives patients expected waiting times and information on cancer charities and support groups. It also offers news and weather updates and has an almost limitless potential for future applications. David Baslinton, the Oncology Department’s Business Manager, explained that the Visual Planet system offers many advantages over their old messaging method. ‘We used to just have notice boards and paper posters,’ he said. ‘This can look very messy and the information quickly gets out of date – but it can be very time consuming to produce the material and change the displays.’ The department needed a system that could keep up to date and manage a quick-changing varied content. The Visual Planet system was chosen both for the range of content it displays and the ease with which it can be managed. ‘The content is the most important part and it’s vital to keep it fresh and relevant,’ said Visual Planet’s Technical Director Vernon Spencer. ‘Other systems use looped material on CDs, so the same content keeps repeating. But our system uses internet technology, so content can be managed remotely and changed automatically.’ The system is both easy to use and versatile. ‘We have several staff who have been trained to use it,’ said David, ‘and because so much of the display is done automatically – it turns itself on and off at the right times and gets news feeds straight from the BBC website – it’s a job that takes barely any time.’ Vernon Spencer at Visual Planet Ltd Tel: 0845 1235370, www.visualplanet.biz

32

Cushioning Recovery

GPs can use a free patient reminder service to reduce the 13.5 million appointments that are missed each year. The text-based appointment reminder system, MJog Light, was developed by Cambridge company Soft Option Technologies. It uses Connecting for Health’s (CfH) NHSMail to deliver reminders direct to a patient’s mobile phone 24 hours before an appointment. Research has shown that 40% of DNAs are a result of forgetfulness, and that almost 13.5 million GP appointments and nearly 6.5 million practice nurse appointments are missed each year. Trafford Hospital has been using MJog for over a year now and the system is at work in 14 of its clinics. The hospital saw its ‘did not attend’ rates reduced from 11.2 to 7.5 percent in the early stages of the trial. John Bain, Head of Information Management & Technology (IM&T), reports that Trafford has been able to provide 40 more appointments for each 1000 texts it sends, helping to meet its 18-week patient pathway objectives. It is also possible for the text message to include important information, for example if the patient should bring a urine sample, or if they are not allowed to eat prior to the appointment. MJog Light can even support different languages to communicate with patients of all nationalities. It can also be used for recruiting patients for special clinics or services, for example asthma clinics, stopping smoking and diabetic monitoring, providing new revenue streams for practices.

For further information please contact Emma Powell tel 01353 741641 or email e.markowski@mjog.com.

The Physio-Master was the brainchild of Jill Parker from the Princess Royal Hospital, Telford, and was brought to market with the support of Arrow Medical Ltd, which provided product development, production-engineering, assembly and distribution support to Medical Devices Technology International (MTDI), which is marketing the product. The deal was the result of link-up by Medilink West Midlands. Arrow Medical uses a number of techniques to produce the PhysioMaster to MDTI’s specifications, including multi-layer fabric assembly, sewing and heat sealing and high precision radio frequency welding. A unique multi-layer fabric construction uses a cellular polymer core, created specifically for Physio-Master, which allows it to be quickly deflated. This makes it easy to store and pack, while manual inflation is avoided so that patients with respiratory problems can use the device freely and hygienically. The Physio-Master helps patients to replicate the action of walking, to benefit blood circulation and also aids rehabilitation of lower limb circulatory problems, such as lymphoedema and swollen ankles. It can also help patients with balance problems by supporting improvements in pro-prioception, which, while assisting the elderly and other patients recovering after injury, also helps athletes improve reaction times. For information contact : John Johnson 01544 231760 www.arrowmedical.co.uk

Feet on the Ground West Midlands company BS2005 Ltd have been working with Ayr Hospital in Scotland on a new pilot scheme which has proven to save time and money, reduce waiting lists and aid infection control. As part in the Scottish Government’s Planned Care Project, the Day Surgery Unit at Ayr Hospital looked at all various processes involved in getting patients through their operation, from admission to discharge. Day Surgery patients are selected on the basis that they are relatively fit and well pre-operatively, but it turned out that patients were still being taken to theatre on an operating trolley even though they could walk there. Once there they had to change trolleys.

The whole process needed an escort of two staff to manoeuvre the trolley. A pilot study was made of walking patients to theatre. To reduce the risk of contaminating the theatre area patients needed to wear over-shoes, and BS2005 was selected to provide an automatic overshoe dispenser. A feedback survey confirmed an overwhelmingly positive reaction to the change. It meant that theatre lists ran more efficiently due to the prompt and efficient arrival of patients, and staff were able to spend more time preparing patients in the pre-operative ward. The project shows how small changes can make substantial improvements to the quality of patient care.

For information contact: jennie@bs2005.co.uk www.bs2005.co.uk 01384 484772

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REVIEW

IN BRIEF

injecting health Opal’s Glittering Performance these ‘problem’ molecules more suitable for the worldwide healthcare market.

Opal has built a particular niche in the redevelopment of generic drugs with complex barriers to entry. These may be drugs that are difficult to manufacture, or drugs with packaging issues which do not usually generate sufficient income to interest the larger pharmaceutical companies.

Sometimes the improvements will be relatively straightforward, such as improving the way a product is packaged. In other cases the problems are more complex and will require more intensive research. For Opal’s cardiovascular drug Amiodarone, for example, the scientists had to develop a manufacturing technique that would improve the product’s stability. The company subsequently won the tender to supply the drug to around a third of hospitals in the UK.

Opal Healthcare has established a reputation for taking these older molecules and redeveloping them so they meet the needs of clinicians and patients more effectively. OI Sciences will spearhead the development of the Opal’s own portfolio of remanufactured generic drugs. Scientists will focus on research and development to make

OI Sciences will be listening closely to the views of doctors and clinicians to identify ways in which existing drugs could be improved. It will also be working alongside groups such as the National Safety Patient Campaign to ascertain whether the way in which the product is manufactured or packaged can contribute to better patient safety.

Less than two years after relocating to the South West of England from its native Oxfordshire, Opal Healthcare has launched an independent spinout company, OI Sciences.

PLAYING SAFE WITH SHARPS both prevent post-procedure needlestick injuries and reduce the risk of cross-contamination. At present all sharps must be disposed of into a Sharps Bin for incineration – and sharps bins are never recycled but always incinerated. The Needlesmart technology means that sharps can be disposed of in clinical waste bags. While these must still be incinerated, using them could reduce the number of Sharps Bins for incineration by 70%.

A fledgling medical devices company, NeedleSmart, has developed an electronic bench-top appliance which safely and hygienically melts hypodermic needles as part of the sharps disposal process.

Needlestick injuries are one of the top accident risks in UK hospitals: healthcare union Unison estimates there are 100,000 ‘sharps’ injuries per year. These injuries can transmit fatal diseases including hepatitis B, hepatitis C and HIV. Using NeedleSmart can

For further information contact: Cliff Kirby, info@needlesmart.com 34

The Needlesmart technology offers efficient disposal that saves costs: it cuts both the amount of sharps bins in use and the number and frequency of sharps bins incinerated. Even more importantly, it can reduce the number of needle stick injuries – and the costs of associated claims. In the longer term the company aims to develop a device specifically to clean the used syringe so that it can be recycled.

www.needlesmart.com


Working together works

MedilinkUK

working together to raise the profile of the medical and healthcare sectors in the United Kingdom

Medilink UK Members BioBusinessNI The Innovation Centre Northern Ireland Science Park Queens Road, Queens Ireland Belfast BT3 9DT Tel: 028 9073 7949 Web: www.biobusinessni.org MediWales 5 Schooner Way Atlantic Wharf Cardiff CF10 4DZ Tel/fax: 029 2047 3456 Web: www.mediwales.com Medilink Yorkshire & Humber 301 Glossop Road Sheffield, South Yorkshire S10 2HL Tel 0114 222 7451 / 6317 Fax 0114 273 0058 Web: www.medilink.co.uk

The UK Health Technologies Business Network

Regional Representatives Medilink North West Innovation Unit Postgraduate Centre Annexe Manchester Royal Infirmary MRI Manchester M13 9WL Tel: +44 (0)161 901 2513 Fax: +44 (0)161 276 5491 Email: enquiries@medilinknw.co.uk Web: www.medilinknw.co.uk Cels Ltd Bioscience Centre International Centre for Life Times Square Newcastle upon Tyne NE1 4EP Tel: 0191 211 2560 Fax: 0191 211 2596 Web: www.celsatlife.com Medilink West Midlands 4 Greenfield Crescent, Edgbaston, Birmingham B15 3BE Tel: 0121 452 5630 Fax: 0121 454 2325 Web: www.medilinkwm.co.uk

Medilink East Midlands BioCity Nottingham Pennyfoot Street Nottingham NG1 1GF Tel 0115 912 4330 Fax 0115 912 4331 Web: www.medilinkem.com ERBI Ltd Meditrina Building Babraham Research Campus Cambridge CB22 3AT Tel: 01223 497 410 Fax: 01223 497 415 Email: medtech@erbi.co.uk Web: www.erbi.co.uk/medtech South East Health Technologies Alliance (SEHTA) Suite H3, Leatherhead Enterprise Centre Randalls Road Leatherhead KT22 7RY Tel: 0845 130 8179 Fax: 0845 345 1683 Web: www.sehta.co.uk Health Technologies KTN c/o TWI Ltd Granta Park Great Abington Cambridge United Kingdom CB1 6AL Tel: 01223 899 000 Fax: 01223 892 588 Web: www.healthtechktn.com

South West of England Regional Development Agency Corporate Headquarters Sterling House Dix's Field Exeter EX1 1QA Tel: 01392 214 747 Fax: 01392 214 848 Email:enquiries@southwestrda.org.uk Web: www.southwestrda.org.uk NHS Innovations London West Wing, 6th Floor 250 Euston Road London NW1 2PQ Tel : 020 7380 1700 Fax: 020 7387 5540 Email: info@nhsinnovationslondon.com Web: nhsinnovationslondon.com Targeting Innovation Scotland Targeting Innovation Ltd 169 West George Street Glasgow G2 2LB Tel: +44 (0)141 572 1602 Fax: +44 (0)141 572 1608 Email: kwilson@targetinginnovation.com For more information visit: www.medilinkuk.com


MediLink UK Review - Spring 2009  

Trade Across the Pond: Bringing UK health technologies to the USA Health on the Home Front: Moving healthcare from hospital to home Comment:...

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