MediWales Review - Winter 2008

M E D I W A L E S

Making it Better Welsh wound networks

Shake On It Kineticallypowered light

Breathe Easy New artificial lung

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Recognising the importance of Welsh health technologies

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The Point of Care

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patients are its most important beneficiaries. In our last

Making it Better The networks behind Wales’s exceptional achievements in wound healing

SMEs: in this one, we look at innovations that arise from people working within, or closely with, the NHS. It’s long been clear to people working in the sector that there is no magical recipe for innovation: either for generating it, or getting the results to

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Contents

When it comes to UK innovation in medical technology, NHS edition, we explored that issue from the perspective of

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PRODUCT REVIEW Shake on it 11 Kinetically-powered light source for medical instruments

patients who need it. But it’s equally clear that whatever your environment, at least one vital ingredient is finding the right people to work with.

RESEARCH REVIEW

The groups and companies featured in our articles have done, and continue

Breathe Easy 14 A radically new respiratory aid

to do, just that – and a key feature of their environment is access to essential NHS clinical expertise. They also have in common a bias for innovation, and a commitment to improving the treatment and care of patients worldwide.

It’s this ethos that informs the innovations they’ve already achieved, and

AWARDS REVIEW Recognising Success 17 Winners of the 2nd MediWales Innovation Awards

those they continue to develop. The ones we review here aim to resolve practical problems in the diagnosis and treatment of patients, from the comparatively simple to the highly complex. Their solutions are among the many that offer an essential resource to our highly valued, and even more highly pressured, NHS. The more endemic the health problem, the more vital such solutions become.

After our Annual Review in the Spring, our Summer edition will lead with a feature exploring the care of elderly people in Wales. Given the UK-wide demographic of an ageing population, this is a problem that can only become more significant.

We are keen to hear from MediWales members and other readers who are working in this area, and would urge potential contributors to contact the editor. In the meantime, as always we welcome your comments, queries and

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The Smart Bandage is designed as a bioactive dressing, responsive to wound condition and able to signal important changes such as bacterial infection to the clinical carers

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ideas.

Coralie Palmer Editor

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Making it Better Coralie Palmer looks at Wales’s exceptional achievements in wound healing, and at the evolution and activities of the groups that make it happen.

Wound healing is traditionally one of those ‘Cinderella’ areas of medicine. By contrast, in Wales it has become the focus for some of the world’s most innovative and highly respected work in clinical care, research and education.

last year succeeded in bringing to Wales a notable new addition to their ranks. In the face of competition from Britain’s most renowned institutions, Cardiff University, the Swansea School of Medicine and Swansea’s Morriston Hospital were collectively chosen to host the Healing Foundation UK Centre for Burns Research, along with a Chair of Burn Injury Study at Cardiff.

At the heart of this activity is a network of specialist groups serving the complex, cross-disciplinary needs of wound healing. The Wound Healing Research Unit (WHRU), the Cardiff Institute of Tissue Engineering and Repair (CITER), Ffenics (the Burn Injury and Tissue Repair Network), and most recently the Welsh Wounds Special Interest Group have all emerged in Wales over the last two decades.

The decision was a public recognition of Wales’s outstanding track record in this field. Which begs the question: why, I asked WHRU’s Director Professor Keith Harding, should such an active network have evolved here?

‘Perhaps it’s serendipity,’ he said, ‘but for some reason there is a bigger collection of interested parties commercially, clinically and academically in Wales, than there is elsewhere on a population basis.’

The wound healing groups have been quick to seize the opportunities this offers – as illustrated by WHRU’s own history.

Combining the best resources of industry, the NHS and academia, the collaborative talents of these organisations are formidable, and

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When it was founded in 1991, as part of the then University of Wales College of Medicine (now merged with Cardiff University), the WHRU was the first research unit in the world to specialise in this subject: it’s now one of the largest specialist wound healing centres worldwide.

From the outset, Keith was determined that the Unit should not only provide expert clinical care but integrate contributions from both academia and industry. In doing so, it would provide a sound scientific basis for its work, and facilitate its translation into products and services for improving wound treatment.

Equally important in shaping the Unit’s character was the condition that it should be entirely selffunding. ‘The ultimate aim,’ Keith explained, ‘was always that academia, the NHS and the commercial world would each contribute a third. Universities and

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the NHS can provide long-term and medium-term funding respectively – but to access these you need to have built a track record. So I could see that our most immediate source of funds would be in developing our links and partnerships with industry.’

The WHRU was perfectly positioned to offer essential services for product research and development to companies in the wound healing field.

It had on tap academic expertise, access to patients for clinical trials, and highly skilled clinical staff who could review products and provide educational and training support.

Keith hit on the idea of the WHRU ‘Gold Card Club’, whose member companies contract to buy these services to a given value over a given period – initially a fixed term of five years, which gave the developing Unit some financial security while allowing time for funding from the other two sources to be grown.

The scheme took off and became a permanent and vital part of the WHRU remit, with members now

signing to a three-year rolling contract. They include all of those who first signed up 17 years ago, as well as international names such as Johnson & Johnson, Convatec, and Smith & Nephew. In the meantime the WHRU has become both a full Department within the University and an NHS Directorate.

The experience of one Gold Card member, Frontier Therapeutics, exemplifies the benefits of a sustained working relationship with WHRU. One of the Blackwoodbased Frontier Group, the company is licensee for a product in one of the WHRU’s key areas of wound care research: the prevention and treatment of pressure sores.

Notoriously hard to heal, these chronic wounds currently cost the NHS some 2.3 billion a year to treat.

Frontier’s ‘Repose’ range provides inflatable pressure-relieving support surfaces, based on a concept originally developed by the University Hospital of Wales that first took the company’s interest a decade ago.

But before deciding to license the technology, Frontier needed rigorous proof of its clinical efficacy. Given its expertise in just this area, it was the WHRU that the NHS commissioned to do a Randomised Clinical Trial, and its results – published in 1999 – provided the essential independent validation for Frontier to go ahead.

‘But we had other products that we wanted to develop from that,’ said Frontier’s Managing Director Nick Davis, ‘and it was essential that we build up the clinical evidence. So we joined the Gold Card Club’.

What that means in practice, he explained, is that Frontier and the

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WHRU agree on a product support programme according to need: ‘We might want interface pressure testing on a product, some advice on one particular aspect of usage, some technical support on another, a paper written for explanatory literature. And we also use the WHRU to liaise with our customers, and demonstrate how the product works in hospital environment’.

Quarterly meetings review progress to date, against a costed statement of the value of work already done.

In successfully marketing the Repose products, clinical evidence was key. But Frontier also benefited from its highly experienced sales team, who knew how to target the newly emerging nurse specialists in tissue viability and the influential networks in the field – and here again the WHRU played a part.

‘One of the things Keith Harding encouraged us to do,’ said Nick, ‘was to become a corporate member of the European Pressure Ulcer Advisory Panel (EPUAP).’

Now 10 years old, this group brings together front-ranking European specialists and leaders of opinion to explore this common problem.

‘That was a very good environment for us,’ Nick continued. ‘The reputation of Keith and his colleagues at WHRU opened doors, and helped to start build our relationships and marketing to other European countries.’

This ability to work across customary boundaries is typical of the wound healing networks, and is the essence both of what CITER does, and how.

The idea for the group originated at a meeting of the European Tissue Repair Society in 2001, to which then-president Keith had invited speakers from the widest possible

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range of Cardiff’s interested parties. From the stimulating connections made between these specialists, the concept of CITER took shape. Formally launched in 2003, CITER’s remit is to bring together scientific and clinical expertise from throughout Cardiff University. Its 130-strong membership is drawn from 11 different Schools ranging from Social Sciences to Engineering, with particularly strong representation from Pharmacy, Biosciences, Dentistry and Medicine. Working across complex and diverse areas of research and clinical activity, it aims specifically to translate cutting-edge science into active improvements in patient care.

‘Our whole ethos,’ explained CITER’s Manager Sarah Hatch, ‘is that of “bench-to-bedside” – to foster the route from lab bench to practical application.’ Dr Phil Stevens, Head of Tissue Engineering & Reparative Dentistry, is on CITER’s executive and also chairs its Research Committee. He described how this ethos is put into practice, using the example of the Smart Bandage project: ‘This is a bandage designed to be responsive to wound condition,’ Phil explained, ‘and able to signal important changes to the clinical carers.’

A £1.4 million grant from the Engineering & Physical Sciences Research Council (EPSRC) funded collaboration on the project between CITER, WHRU, and scientists from universities at Bristol, Imperial College and King’s College London. ‘The chemists are helping us to develop molecules that can recognise and ‘report’ the presence of particular bacteria,’ Phil continued, ‘and our engineering colleagues are working on a micro-detection system to translate that into an electrical signal that can be transmitted as a read-out.’ This precise information

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will enable better-targeted drug therapies and more timely interventions to speed the healing process.

Work on this bioactive dressing is proceeding apace. In the much longer term, there is the possibility of a system whereby the bandage could be loaded with a specific treatment that would be released only when the appropriate signal is received.

‘Obviously this is something of a utopian prospect right now,’ said Phil. ‘But then in the beginning the current Smart Bandage concept was viewed as very ‘blue sky’ – and now we’re well on the road to making it happen.’

CITER’s core activities are designed to address the generic challenges posed by this kind of collaborative work. As might be expected, the sourcing of grants is one of these priorities, in particular co-ordination of the larger and more complex proposals that cross disciplinary boundaries. But equally essential in channelling the talents of its diverse membership is CITER’s adventurous – and extremely popular – interdisciplinary events programme.

Last year’s workshop on the clinical applications of stem cell research followed a typical pattern: attended by some 200 people over an afternoon, its 10 speakers included Cardiff’s recent Nobel Prize-winner Sir Martin Evans, as well as Professor Stephen Dunnet and Dr Anne Rosser, the duo who brought stem cell research to the first clinical trial for Huntington’s disease. With short presentations followed by Q&A sessions, the concentrated information packed into these events is shared with the widest possible audience – a deliberate strategy on the part of the Research Committee.

In collating talent, expertise and technology on a given theme, the

Treating a chronic foot wound

seminars ensure that Universitywide, the right hand knows what the left is doing. In addressing such a broad mix of delegates, they also demand that specialists from all disciplines work to overcome the barriers of concepts and terminology that are strange to one another. ‘These workshops are pretty intense,’ Phil acknowledged.

‘There’s a lot of information, a lot of it outside your own field of reference. But it’s essential to develop an understanding of the principles at work and how those might apply to your own research.’

The interdisciplinary focus of CITER and the WHRU links them in a close-knit exchange of talents and activities, generating not only their collaborative projects but new additional networks.

Sharing a common ultimate goal – better treatment for the patient – the two groups work to it from a differing and complementary direction. ‘While CITER’s route is “bench to bedside”,’ said Keith, ‘you could say that ours is ”bedside to bench” – it’s arises out of our experience as clinicians that indicates a clinical need.’ This emphasis is reflected in the three major strands of the WHRU’s own research programme.

Research on Physical Measurement is headed up by Dr Michael Clark, whose expertise on pressure ulceration has an international reputation. In collaboration with the Department of Electronic Engineering & IT at the University of Glamorgan, work on these measures covers every aspect of wounds from the pressure upon them to their size, temperature or colour. Outcomes Research is headed by Professor Tricia Price,

who has developed and validated the first disease-specific ‘Quality of Life’ tool for assessing the impact of chronic lower leg wounds – a landmark in the ongoing work to establish rigorous Quality of Life criteria.

The third area, Biological Research, is now mostly done through CITER – the Smart Bandage being just one example of the ‘return trip’ to clinical care facilitated by this exchange. Likewise, both groups support interdisciplinary qualifications that incorporate a crossover between their respective bases of pure research and clinical care: CITER provides a diploma and MSc in Tissue Engineering, and the WHRU offers both a postgraduate Diploma and an MSc in Wound Healing and Tissue Repair.

This well-tested combination of multidisciplinary expertise was further expanded in 2006, when

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WHRU and CITER came together with the Swansea School of Medicine to establish Ffenics, the Burn Injury and Tissue Repair Network for Wales. Since 1994, work in this field has been sited at Swansea’s Morriston Hospital, in the Centre for Burns and Plastic Surgery led by its Director William Dickson. ‘This was the one speciality not represented at Cardiff,’ said Keith, ‘So I began discussions with the Centre’s Director and senior consultants about developing links between their surgery departments and ours.’

It was this evolving relationship that ultimately gave birth to Ffenics (appropriately, Welsh for ‘phoenix’).

Now managed by CITER’s Sarah Hatch and WHRU’s Prof Price, the Ffenics network mirrors the CITER “bench to bedside” philosophy, but with a specific focus on burns wounds and treatment. In turn, Ffenics was a vital component in the bid – co-ordinated by Dr Price – to bring the Healing Foundation UK’s Centre for Burns Research to South Wales. ‘It was crucial having access to the patient base through Morriston,’ explained Sarah. ‘We were able to submit a cohesive bid which covered clinical care and support, research, and a first-class facility. And behind that was a wellestablished collaborative track record that proved we know how to make these complex networks function.’

The new Centre aims to improve both treatment and long-term support for burns survivors, covering research from infection control and immunology to postburn inflammation and scar formation. But it will also focus on important issues such as the personal and social aspects of living with burn scars, long-term rehabilitation and prevention. The recruitment process for Cardiff University’s accompanying Chair in Burns Injury Study began last year

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and is now close to confirming an appointment.

Meanwhile, last autumn the inaugural meeting of the Welsh Wounds Special Interest Group attracted over 40 participants.

Coming from a mix of academic, clinical and commercial backgrounds, the turnout highlights the strength of interest in wound healing within Wales. ‘We sourced funds for this with the help of the Wales Innovation Relay Centre and MediWales,’ said Keith. ‘It’s my view that with all these interested parties involved in high-quality work, we should come together under a common banner. So why not work to make Wales the centre of wound healing in the UK?’ The work already accomplished, and the reach of its continuing expansion, suggest that events may already be moving in that direction.

Wound Healing Research Unit (WHRU) School of Medicine Cardiff University Heath Park Cardiff CF14 4XN Tel: 029 2074 4505 Fax: 029 2075 6334 Email: admin@whru.co.uk Web: www.whru.co.uk Welsh Wounds Special Interest Group Contact WHRU

Frontier Therapeutics Newbridge Road Industrial Estate Blackwood NP12 2YN Tel 01495 235 800 Fax 01495 235 808 Email info@frontier-group.co.uk Web www.frontier-group.co.uk

CITER Cardiff University 51 Park Place Cardiff CF10 3AT Tel: 029 2087 0129 Email: hatchs@cf.ac.uk Web: www.citer.org Ffenics Contact CITER Swansea School of Medicine Swansea University Singleton Park Swansea SA2 8PP Tel: 01792 513404 Fax: 01792 513430 Email: d.v.ford@swan.ac.uk Web: www.medicine.swan.ac.uk

Make the most of Your Medical Technology Forum The Medi Wales Review Mailed to over 1500 contacts Distributed on line via the MediWales website visited over 5000 times per year Distributed at MediWales events and trade shows to over 500 leads The MediWales team would like to hear from members and colleagues who have news about new products, services or initiatives that would benefit from the publicity in the MediWales Review Press releases and to discuss inclusion in articles and features coralie.palmer@mediwales.com Advertising, reprints and special supplements debbie.laubach@mediwales.com

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Shake on it than with conventional bulbs. An ergonomic non-slip handle allows the ShakerScope to be used upright or inverted by left- or right-handed users.

A new kinetically-powered light source offers low-cost flexibility for a range of medical inspection instruments.

David’s experience of medical work in developing countries prompted the device’s original conception as an ophthalmoscope (to examine eyes), but the technology’s potential for a multiple-use instrument rapidly became clear. The ShakerScope now incorporates a universal hook mounting for interchangeable attachment heads, so that the one device also functions as a laryngoscope (for throats) and otoscope (for ears) – a versatility bringing additional savings in cost, space and weight.

Hand-held devices for examining parts of the body such as eyes, ears, nose and throat form an essential part of many a medical toolkit.

These instruments typically need a bright light for a short time, usually provided by mains or battery power and an incandescent bulb. But these components come at a cost, both financial and environmental: bulbs break or burn out, batteries run down, leak or corrode, and both must be disposed of.

Now Dr David Williams and Dr John Dingley, consultant anaesthetists at Swansea’s Morriston Hospital, have invented an adaptive light source specifically developed to power such instruments, based on the Faraday principle. Inspired by the example of Trevor Baylis’s Freeplay clockwork radio, the duo’s ShakerScope uses neither mains nor battery power, but kinetic energy.

charge for many days before it needs to be re-charged by shaking.

Simply shaking this small, handheld device moves a magnet in a coil, which – as Faraday demonstrated in 1831 – generates electricity. This in turn illuminates a high-intensity white LightEmitting Diode (LED) that is transmitted to the instrument head via fibre optics. A 60-second shake provides over eight minutes of ultrabright light – more than ample for clinical requirements. If not used immediately, the power is stored: the ShakerScope will retain its

Each of this device’s constituents contributes to an ultra-efficient unit.

The Faraday generator has just one moving part, and can be manufactured at low cost as a sealed unit which is proof against water, dust and humidity. LEDs average a lifespan of over 100,000 hours and are impervious to electrical and mechanical shocks, vibrations, and environmental extremes, while their corrected colour temperature (CCT) gives tissues a more realistic appearance

In taking the ShakerScope from bright idea to functioning prototype, its inventors had to run the full gamut of ‘learning by doing’.

From the outset, both doctors were determined to do as much of the development process as possible for themselves. Indeed its early stages followed the classic ‘two men in a shed’ model of British innovation, not least because at this point the project was self-financed. Working in their spare time, the two clinicians learnt how to manipulate metals, plastics and electronics through practical application, as they developed a series of experimental models.

Underpinning this approach was an awareness of the device’s intrinsic Intellectual Property (IP) potential.

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stage: ‘We knew we’d taken it about as far as we could using our native resources,’ said David, ‘and that we needed professional redesign for manufacture.’

ShakerScope subcontracted this work to two Welsh companies: the electronics to E2L, an electronics consultancy based in Monmouth, and the plastics and prototyping to product design and development centre PDR in Cardiff. E2L incorporated a microprocessor controller that maximised light brightness and duration, and an improved user interface so that the LED would light up when the device was fully charged, and flash a warning when running low. PDR redesigned the housing for improved functionality and styling, and then using disposable polymer moulds – which enable low-cost production of 10-15 items – was able to provide ShakerScope with 10 pre-production prototypes.

With high-quality prototypes to hand for demonstration, from autumn 2007 the company could focus on generating awareness in potential customers and interest from potential manufacturers.

Dr John Dingley demonstrating the ShakerScope with laryngoscope attachment to insert an endotracheal tube

‘We knew that’s where the financial value lay,’ David explained, ‘so our view was that the closer we could get to market under our own steam – without giving away equity or incurring costs – the better.’

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In 2005 the ShakerScope reached the finals of the Medical Futures Innovation Awards, and that provided a spur for consolidating the team’s legal position. As practising

clinicians, David and John were working full-time for both Swansea University and the NHS, so it was necessary to negotiate terms with both parties. The NHS, it transpired, had no interest in contributing to the development process and therefore did not seek equity. A link with the University, on the other hand, was likely to be important in providing access to grant funding.

In return for a five per cent stake, the team were able to set up themselves up as a University spinout company as part of the Technium group. The University then helped to source a design and development grant of £7,000 for ShakerScope Ltd from the Welsh Assembly Government, which helped to fund patenting for IP protection and development of the device through to the prototype

A medical colleague, while on three months’ military service in Afghanistan, tested a demonstration ShakerScope in ‘front line’ field hospital conditions. The device performed very well, and the clinician has now submitted an article to an armed forces medical journal describing its benefits.

Another of the demonstration prototypes was lent to PDR, who submitted it to the prestigious annual International Forum Design competition at Hannover, one of the

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world’s biggest and best-known design centres. The iF seal of design quality has become an internationally recognized trademark, and the Shakerscope has won a 2008 award for product design, alongside major international companies.

Meanwhile the London Mayor’s June visit to Cardiff will feature the ‘Orbis’ charity, who provide equipment and surgical teams for treating eye disease in developing countries.

The Welsh Assembly Government is currently discussing the possibility of demonstrating the ShakerScope during the visit, and also looking into accessing funding to help the company with further development of their eye-examination attachment.

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BioWales 2008 website, and on WIRC’s technology transfer website.

ShakerScope Ltd Digital Technium Centre University of Wales Swansea SA2 8PP Tel: 01792 513129 Fax: 1792 513370 Email: sales@shakerscope.com Web: www.shakerscope.com

BioWales 2008 Web: www.biowalesevent.com

Wales Innovation Relay Centre Web: www.walesrelay.co.uk

Although originally designed for developing countries, the other potential applications for the device are legion, including anaesthetic and resuscitation trolleys, paramedic and military kits, commercial aviation, and veterinary medicine. New heads are being constantly developed for use in dentistry, nasendoscopy, gynaecology and proctoscopy. A miniature version of the ShakerScope has also been developed for use as a pen torch to examine the mouth and pupillary reflexes.

The next stage in getting the product to market is to secure CE marking and ethical approval for human studies prior to production, and Welsh Innovations in Healthcare (WIsH) is helping the company in its search for appropriate manufacturing licensee.

ShakerScope will also be taking part in the Biopartnering brokerage event hosted by the Wales Innovation Relay Centre at the BioWales 2008 conference in Cardiff: further details can be found in the ShakerScope listings on the

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Lung disease exacts a dismal toll worldwide on human health – both in deaths, and severely compromised quality of life for survivors. The World Health Organisation estimates that Acute Respiratory Infections (ARIs) – diseases such as pneumonia and tuberculosis and newer conditions like avian ‘flu – kill almost four million people a year worldwide.

Chronic lung diseases like emphysema and cystic fibrosis are also widespread: sufferers’ deterioration is slow, distressing and ultimately fatal without a lung transplant.

At present, the standard respiratory aids for these conditions augment the working of the lungs themselves, through mechanically

supported breathing and/or oxygen administration – methods that essentially force damaged lungs to work harder. But the new Haemair device bypasses the lungs altogether, by exchanging oxygen and carbon dioxide directly via the bloodstream. Until now, this method has been limited to ‘extracorporeal life support’ devices that can only be used with anaesthetised or moribund patients.

Haemair’s design is the first to take over “breathing” in this way for conscious and mobile patients, allowing their lungs to rest and recover.

The ubiquity and severity of lung diseases makes such a device desperately needed, and Haemair is now embarking on the development of its first prototype. About the size of a hardback book, this fully external device is connected to the patient’s bloodstream. Within the device, the blood travels through hollow polymer fibres, over which oygen and air are passed. Because the fibres are microporous, the

The Haemair display which ran last summer in the British Science Museum's Antenna science news gallery

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became a non-executive Director of the company.

Breathe Easy A radically innovative design for an artificial lung offers new hope to the millions of sufferers who currently struggle with, and die from, lung disease or damage.

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blood can pick up this oxygen and then return to the patient’s bloodstream as fully oxygenated blood. ‘So in essence, this is a blood/air mass exchanger that imitates how the lungs themselves work,’ said Dr Steve Brown, the project’s Senior Engineer.

Natural healthy lungs, he went on, contain about 700 million alveoli (tiny air sacs at the end of the lung’s airways) where oxygen is exchanged for carbon dioxide. How effectively this exchange works depends on the individual: consistent heavy smoking, for example, can reduce lung capacity to 40%. Patients in the terminal stages of acute or chronic lung disease may have less than 20% of their original lung capacity, so that adding even another 20% radically improves their condition. The efficiency of the Haemair device is such that it can provide patients with 60-80% lung capacity.

With its ability to replicate and replace lung function, the clinical effect of the Haemair device would be dramatic.

The device could be used for a range of conditions over varying periods of time. This could be a matter of hours in emergencies such as recoverable breathing failure from asthma for example, or trauma where lung function is severely impaired. For patients with ARIs, it would be applied for two or three weeks: allowing lungs to rest in this way maximises both the impact of any drug treatment and the chances

Detail from the Haemair display showing thermotrophic fluid being pumped through the mass exchanger and back around in a loop.

of full recovery without lasting lung damage.

Used for more extended periods of months rather than weeks, the device offers both better treatment and improved quality of life for sufferers of chronic diseases. For those at home, increased lung capacity through the Haemair would also increase mobility, while doing away with the dead weight of the oxygen cylinder; for those hospitalised, it would reduce the necessity for treatment in Intensive Care Units. Currently, about 50% of the most severely affected patients with emphysema or cystic fibrosis die while waiting for a lung transplant: of those who receive one, 30% die during or soon after the operation. Treated with this device, patients would be in a fitter and stronger state for the operation, and better able to survive it.

Haemair’s prototype design for an external device would be applicable to the shorter-term usages. The ultimate aim however is to produce a range of respiratory aids based on this initial design, differing according to the type and duration of treatment. In the longer term, Haemair intend to apply the same concept to a fully implantable device – which could actually represent an alternative to transplantation.

While the principle – direct gas exchange via the bloodstream – might be straightforward, its development as a device presents complex challenges both technically and collaboratively.

The original idea was conceived by Managing Director Bill Johns after his son Graham died of cystic fibrosis at the age of 32 – a premature death sadly typical of this disease. Bill, a chemical engineer by training, worked to develop and refine this idea with his colleague Alan Evans, who also had an engineering background and

Representation of how a fully implanted Haemair device may be situated within the chest cavity

Having patented the concept, the fledging company’s first task was to seek the academic input needed to resolve the complex problems of blood flow and biocompatibility.

From institutions all over Europe, it was Swansea University, and in particular its Centre for Complex Fluids Processing, that proved best equipped for the task. Led by Professor Rhodri Williams, the Centre was contracted to provide Haemair with access to its formidable expertise, along with essential equipment, facilities and technical support.

As luck would have it, Adrian Evans, consultant in emergency medicine at Swansea’s Morriston Hospital was at that time already working with Prof Williams on the problems of blood flow. He immediately saw the potential of the Haemair device, and now leads the NHS role as the third key partner in the project.

With the collaborative team in place and the company firmly established in Swansea, Haemair successfully applied for a Welsh Assembly Government’s Smart Cymru award which helped secure their funding for the next two years of R&D. The project has been notably successful in meeting its developmental targets, now culminating in design of the initial prototype.

For a financially pressured NHS, the potential savings offered by the Haemair device would have a substantial impact. Patients with advanced lung disease may spend months of the year in general wards, and require repeated stays in intensive care at the cost of some £7,000 a week. The weakness effected by ever-decreasing lung capacity is a major factor in the deterioration that produces this pattern: annual costs for each such

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Awards patient can exceed £100,000. The benefits – clinical, financial and human – of the device, and the achievements Haemair can already demonstrate, have won the company a great deal of professional goodwill.

People are therefore keen to see the project succeed, and this support has become another resource helping the company to meet the technical challenges facing them.

The biggest of these lies in preventing blood forming clots because of its passage through the device. As Steve explained; ‘Blood simply hates being outside a blood vessel – its natural response is to clot. Added to that, different lung diseases cause blood to clot at different rates from healthy people, depending on the disease.’ At Morriston’s Clinical Haemorheology Laboratory, researchers are working on the first studies done anywhere to determine the precise effect of particular diseases on clotting times.

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A priority therefore is to establish the appropriate means for eliminating this problem. Haemair is currently exploring a number of potential routes to the answer, involving technology from anticoagulants to cellular coatings that replicate the inside of blood vessels.

Liaising with manufacturers, the company is testing a range of biocompatible materials such as the non-thrombogenic (anti-clotting) surface used in stents for treating heart disease. ‘The optimal solution may be down one of these routes, or it might turn out to be a marriage of two or three different technologies,’ said Steve.

The consistently close teamwork between Haemair and Morriston won the company the 2007 MediWales Innovation Award for collaboration with the NHS. As it turned out, the prize of a day’s consultancy with product design and development company PDR was perfectly timed to meet Haemair’s advance to the prototype stage.

‘That consultancy is ongoing,’ said Steve. ‘PDR’s brief is not simply to design the exterior but to contribute to a fully functioning device – they have ideas that have developed out of our discussions which will be really useful to us.’

Using an Atomic Force Microscope to examine a polymer membrane

In developing a prototype the company is embarked on the route to a fully manufactureable device, taking all the project’s work on materials, design and testing to another level – something their strategy has prepared for.

‘The Haemair approach has always been to try and progress all our developmental areas simultaneously, at pretty much the same rate,’ Steve explained, ‘and never to limit our focus in each area to just one option – because if you do that and the option fails, you’re

back at square one. So we’ve managed to avoid that.’ This strategy has maintained the company’s developmental momentum, so that the prototype stage finds each of the different contributing factors in the right place at the right time.

One of those areas is of course testing, which will be scaled up for the prototype so as to run larger amounts of blood through a full circuit of the device – and here Morriston’s work is vital. After that, the next stage would be mammalian testing. ‘The phenomenal thing is,’ said Steve, ‘that if you read clinical reports, especially from US physicians, they say they would use an equivalent device after a brief trial in just one mammalian example, because there’s no alternative. They lose patient after patient after patient. If there’s even a small chance those people could survive, then they’d use it.’

Meanwhile the company is in the process of securing funding to take over from the Smart grant’s expiration in May, to see Haemair through from prototyping to manufacturing its first device. The company’s long-term goal is to establish – whether through corporate investment, licensing or purchase – a viable high-tech manufacturing facility in South Wales to bring this new respiratory aid to a world-wide market.

Haemair Ltd Unit 212 Digital Technium Swansea University Singleton Park Swansea SA2 8PP Tel: 01792 602466 Email: sbrown@haemair.com wrjohns@haemair.com Web: www.haemair.com

Recognising Success Last November, the winners of the second MediWales Innovation Awards were announced at the Annual MediWales Dinner at the Hilton Hotel in Cardiff. Sponsored by JMJ Laboratories Ltd, part of the Synergy Healthcare group of companies, this black-tie event brought together over 100 MediWales members and invited guests to celebrate their achievements over the last year.

The Awards are structured to recognise successful new and established companies, regardless of size, as well as the academic and clinical organisations that are vital to the success of the sector.

In being judged by leading members of the sector, the Awards are all the more valued in according the prize-givers recognition of their achievements by their own peers.

The Judges were Mr Andrew Thomas (Magstim), Dr Sharon Thomas (Welsh Assembly Government), Mr Greg Baily (Huntleigh Healthcare), Dr Nicholas Shilton (Welsh Innovations in Healthcare), Dr Graham Guilford, Mr Martin James (GE Healthcare), Dr Catherine Ramsey (Biotrace Ltd) and Mr David Ford (Swansea University).

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Awards

Awards

For the Second year running MediWales member companies, who provide services to the sector, generously contributed the five category prizes in the form of consultancy days.

This is a novel and effective way to help Welsh companies to work together from a low-risk starting point that often results in longer more significant working partnerships.

The five prizes were contributed by Abel and Imray (patent and trademark attorneys), GX Design Engineers, The National Centre for Product Design and Development Research (PDR), UDL (patent attorneys) and the Manufacturing Engineering Centre (MEC) at Cardiff University.

The Innovation Award was won by BBI Holdings for the development of a rapid point of care device for the detection of a specific virulent strain of the Herpes Simplex virus. BBi are pictured with Simon Haslam of prize sponsors Abel and Imray and Dr. Virginia Chambers.

The Export Achievement Award was won by Dulas who produce solar powered refrigerators for vaccine storage in the developing world. Dulas are pictured with last year’s winner, Rod Palmer from Performance Health Products.

The Growth Award was won by DTR Medical for consistent, sustainable and profitable growth. Swansea based DTR manufacture sterile single use surgical equipment.

The Partnership with the NHS Awards was won by Haemair for work on their respiratory aid which may result in the development of a prosthetic device to replace defective human lungs. Haemir are pictured with Angela Spiteri of prize sponsor PDR.

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Dinner Sponsor: JMJ Laboratories Ltd. part of the Synergy Medical Healthcare group of companies.

Alison Payne and Lisa Sebury with their guests from Synergy Healthcare: Anne Macmillan and Mike Fazal.

The Innovation Award was presented by Dr Virgina Chambers, Director of Technology and Innovation at the Welsh Assembly Government. Dr Chambers has supported the MediWales forum and the wider Welsh life science sectors for many years, so it was a pleasure to welcome her as guest of honour for the night.

The four remaining awards were presented by last year’s winners: Ian Scoular, Protherics.

Rod Palmer, Performance Health Products.

John Maisey and James Brewer, Cardiff and Vale NHS Trust John Starzewski of Magstim.

This gave them the opportunity to report back on the progress of their companies and their products and make informed, eloquent and invariably humorous comments on the state of the sector, its needs and the challenges the industry is facing.

The Start-up Award was won by Sleepworks, manufacturer for the new Snorkil anti-snoring device.

The winners of the MediWales Innovation Awards automatically qualify as regional finalists for the national Medilink UK Awards.

The national Awards are being judged as this article goes to press and will be announced at the MEDEC trade show and conference at the NEC in Birmingham on 13th and 14th of February.

In addition a special mention was given to Shakerscope, a start-up company from Swansea, for their development of a range of kinetically-powered handheld electronic medical devices. Shakerscope are pictured with Gwyn Tudor of MediWales.

MediWales will be launching this year’s Innovation Awards at BioWales on 12th and 13th March. The process has been designed to ensure that companies can enter with minimal paperwork and time commitment. Any company, NHS department or academic department in Wales is eligible and encouraged to get involved either as an entrant or sponsor.

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