MediLink Uk Review - Autumn 2009

AU T U M N 2 0 0 9

ISSUE 3

Pursuing the Evidence Proving the impact of innovative health technologies

Leading the Field M E D I L I N K U K H E A LT H T E C H N O L O G Y AWARDS WINNERS Industry Speaks to Government T H E V O I C E S O F I N D U S T R Y C A M P A I G N A Fair Trial in the UK I M P R O V I N G P H A R M A T R I A L S S I T E S

AUTUMN 2009 ISSUE 3

About HealthTech and Medicines KTN

features

comment

4 Pursuing the The HealthTech and Medicines Knowledge Transfer Network (KTN) supports the Life Sciences Sector for human health KTN Initial Priorities: • Biopharmacetical Bioprocessing • Diagnostics

The KTN is the sector specific business connecting arm of Technology Strategy Board (an executive non-governmental public body) and works closely with key stakeholders to support strategic investments in technology and innovation:

• Medical Devices

• Department for Business, Innovation and Skills

• Regenerative Medicine

• Department of Health • UK Trade & Investment • Research Councils UK • Leading UK Trade Associations The KTN builds an active community of players across business, academia and the clinical base together with key stakeholders to drive forward key knowledge transfer issues and accelerate business innovation

Special Interest Groups Communities brought together to address: • Knowledge Transfer Issues in specific areas • Indentify current and future needs for the sector • Stimulating new partnerships and actions

Current SIGs • • • • • • • • •

Advanced Wound Management Assistive Technologies Cardiovascular Dentistry Drug Delivery Formulation of Biological Medicines Hospital Acquired Infections Medical Device Clinical Studies Operational Excellence in Biological Medicine Manufacturing • Orthopaedics • Regenerative Medicine – Bioprocessing for Advanced Therapies – Tissue Engineering • Urology

Funding opportunities • Technology Strategy Board Research & Development Competitions – Collaborative R&D – Knowledge Transfer Partnerships – SBRI – Innovation Platforms • Research Councils – Bioprocessing Research Industry Club – Industrial CASE PhD Studentships • Department of Health/National

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Evidence

It’s a complex business, so our lead feature is a lengthy one – but with good reason. It became clear that while many people in the industry were expert in particular aspects, it was extremely difficult to make up a coherent overall picture. The material we cover can only summarise, but it does bring together some of the most influential of the many different forces acting on this important activity.

The establishment of the Office of Life Sciences makes this a topical time for such a perspective. We add to it in our Comment section, which gives a view from the pharmaceutical sector; while a report on the Voices of Industry campaign highlights a now permanent forum for putting your views on these and other issues into the public domain.

Our next issue will be tackling a subject dear to the hearts of many readers: the importance of manufacturing. Last year’s financial meltdown has thrown into relief the capacity of innovative health technologies to create wealth for the UK economy (now explicitly recognised by the OLS). We are looking for companies who choose not only to invent but to manufacture their products in the UK, and want to explain why. So if you’re one of them, please contact the editor – the sooner the better.

Coralie Palmer Editor

www.bioprocessuk.org www.healthtechktn.com

projects 18

Prizewinners at the Medilink UK National Health Technology Awards

www.medilinkuk.co.uk

products 20

ks a e p S y Industr rnment to Gove 12

Addressing significant issues in the Life Sciences sector

Well Read Accurate and instant cervical cancer testing

10 Leading the Field

Securely Sealed High-functioning wound seals for surgical resections

in brief 21

Health-centred… In Embryo… Fast Track… Longlife… Learning Curve

biff 26

Great moments in medicine

The Medilink UK Review

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5-7 Schooner Way Atlantic Wharf Cardiff CF10 4DZ Tel/Fax: 029 2047 3456 Web: www.mediwales.com

for Medilink UK

The views expressed in this publication do not necessarily represent the opinions of individual Medilink UK members unless explicitly stated. © MediWales Ltd. 2009

Knowledge Transfer Networks Accelerating Business Innovation; a Technology Strategy Board Programme

What makes a good pharma trial site?

Making the case for health technologies: problems and solutions

Building an evidence base for innovative products is one of the most challenging tasks faced by manufacturers of health technologies. The distinctive profile of these devices makes particular demands on evidence-gathering studies, which need to address the concerns of a range of stakeholders from purchasers and economists to clinicians and patients.

A Fair Trial in the UK

Contact: Editorial coralie.palmer@mediwales.com Advertising debbie.laubach@mediwales.com Coordinator jess.fisher@mediwales.com

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Pursuing the Evidence How do manufacturers build up evidence for innovative health technologies?

Coralie Palmer looks at some of the problems common to devices studies, and at the newest solutions now on offer or in development

For manufacturers of innovative medical devices, establishing a sound evidence base for their technologies is key to getting them used by patients both at home and abroad.

In the UK, the difficulty of getting innovative technologies adopted by the NHS is now acknowledged at the highest level, and speeding their entry has become an avowed priority.

Clinical access for manufacturers plays a vital part in this process, from initial R&D to final procurement. Gathering evidence for the properties of a device is one important stage along that continuum, and comes with its own unique challenges. The nature of devices themselves – the way they are developed, sold, used, improved and replaced – means that manufacturers face particular issues in the design and implementation of evidence-gathering clinical studies.

ItÕs a complex area, and Trusts themselves vary widely as to the evidence they demand and the degree to which they will accept any given piece of evidence as valid. So it’s as well to define our terms: what do we mean by evidence? There are a number of ‘evidence hierarchies’ in circulation that rank types of study design in terms of their rigour and effectiveness. One of the most widely accepted is that developed by the Oxford Centre for Evidence-based Medicine (CEBM). It is now used by many agencies worldwide that produce Health Technology Assessments (HTAs), the recognised process of systematic review that analyses key outcomes in terms of safety, effectiveness and health economics.

As might be expected, the CEBM hierarchy gives evidence from Randomised Controlled Trials (RCTs) the highest placings in its ranking system. Large-scale RCTs to the most exacting standard are of course mandatory in the development of pharmaceuticals, which cannot be approved for sale without them. For medical devices, on the other hand, the only mandatory requirement prior to sale is achieving a CE mark, which demonstrates a device’s performance

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(that it does what it says it will do) and safety. A CE mark does not however indicate comparative clinical efficacy: for this a manufacturer must provide further evidence, and using an RCT to do so often encounters inherent problems.

Paramount among these is the issue of ‘equipoise’ in participating clinicians: that they should not have preconceptions as to the success or otherwise of the device. Since CEmarked devices are freely available – along with information and debate about their properties on the clinical circuit – it is hard for clinicians to avoid coming to their own conclusions in advance of study results.

For Mick Borroff, Director of Strategic Health Outcomes at orthopaedic company DePuy International, the problem is all too familiar. As he explained, the implications are just as problematic when it comes to participating patients: ‘It’s very rare for them to accept randomisation,’ he said.

‘Some years ago we had a multi-centre RCT for a new spinal intervention, but at end of the first year we had to stop it because of poor enrolment – patients randomised to the control group, which involved another three months of conservative therapy, said, “I’m fed up with that, I want the new treatment,” and declined to participate at that point.’

An equally significant factor is that RCTs are notoriously time - and cost intensive. This favours the business model of large pharmaceutical companies, based on high volumes, high margins, and long-lived patent protection. The profile of medical device companies could not be more different: some 80% of the medtech sector is made up of small-to-medium enterprises (SMEs), ranging from the classic ‘two blokes in a shed’ to companies of 250 people.

Most devices are lucky to have as much as a 10-year lifespan, and are all too easily ‘colonised’ by manufacturers who can produce modified versions outside the original patent terms. Equally, volumes and margins are typically far lower than for pharma products: ‘One of problems we have,’ said Oliver Wells, Chairman of the Research &

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Innovation Policy Group at the Association of British Healthcare Industries (ABHI), ‘is that if you follow rigid RCT protocols, there is a minimum business level below which the costs of such trials are simply not supportable. And yet there are many products with very small volumes that are very important in terms of clinical benefit.

‘We feel that you need a richer kind of map for evidence levels,’ he continued.

‘Existing hierarchies of evidence are set up to look at a fairly static response by a complex system to an input. But device technologies are highly dynamic, especially with early versions. You’re trying to estimate dynamic variables, so it’s like filming a racing car with a fixed camera – the image will be blurred. It’s a much more complicated situation.’

The cumulative effect of these factors is that the vast majority of device investigations are, in CEBM terms, ‘Level 4 Case Series’: case studies that rank low in the hierarchy, but which, when well-designed and managed, can still be an effective means of demonstrating device properties. ‘The most important evidence we have about hip replacements isn’t from RCTs,’ Oliver pointed out, ‘it’s from registries of surgical operations. Registries hold all the details of the patient and the device used in the operation, so that you can follow up the outcome – whether the patient needed a revision, or had any side-effects, or died.

Registries consolidate this evidence, so in effect you have a continuous series of case studies.’

The ubiquity of the Level 4 Case Series also reflects the fact that the sheer scope of medical devices, from wheelchairs to Deep Brain Implants, demands a great variety of study designs in a wide range of environments.

The task for manufacturers is not just doing a study in the right way, but making sure that it’s the right kind of study. Products often need evidence to demonstrate not only their efficacy, but the implications of their use in a clinical environment. This often means ☞ 5

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Even with the right protocol in place, lengthy set-up times have been a common problem, with the associated bureaucracy clearly identified as a contributing factor. A long-standing complaint has been the need to negotiate legal agreements for studies with Trusts on a site-by-site basis – with the inevitable (and costly) repetition of procedures. The same problem has dogged application for multiple research approvals and permissions with the array of relevant bodies.

studying a device’s lifetime impact on service delivery within the ‘patient pathway’: the technology’s interactions with staff numbers and time, use of space, movement of patients and equipment, and demand for materials.

Mike Clancy, UK MD of Frontier Medical, described for me one such study into the company’s new pressure area care mattress. Its clinical efficacy has been proven over a decade of studies, but the new design can also be used as a lateral transfer device for moving patients. For this function, after initial in vitro testing and successful laboratory tests with NHS trainees, a study was needed to see if the findings could be replicated in a clinical environment, and to explore the practicalities of use in that setting.

‘Typically when hospital departments get a new device they’ll hoard it – they’ll want to keep it with them for budgetary reasons and so on,’ said Mike. ‘But this particular device stays with the patient so it’s interdepartmental. We need to find a way of tracking the product to identify each of the logistical hiccups that it might hit during the patient’s journey. So some of the study deals with clinical evidence – to check it’s no worse and preferably better than the old design in terms of patient outcomes – but a lot of it is practical issues, like how many mattresses end up at the start point and how many get lost. Now if you want to evaluate 60 patients, you’ll probably need to start off with 90-100 to end up with that final total. At say 14 patients per week, that’s around eight to nine weeks: almost three months of tracking, just to get that evidence. And what you have at the end is a case study – it’s not scientific data.’

This last point illustrates another factor bearing on research design: the potential for publication, which is important for funding in academia.

The findings of the Frontier example would not interest an academic journal (though such studies often appear in nursing journals). Research staff can therefore sometimes push for a design that’s augmented to be more academically significant, but also more complex – and costly – than is needed for the manufacturer’s purposes.

While research design is crucial, the right expert advice can be hard to find.

Contract Research Organisations (CROs) for pharmaceuticals are 6

plentiful, but only some of these cater for any medtech studies. The specifically medical device-focused CRO is a rare beast: one such is Medvance, serving a highly diverse range of products and studies. ‘Often manufacturers aren’t clear about key questions at the outset,’ said the company’s CEO Janette Benaddi.

‘Such as, what are they trying to demonstrate, who for and why? What’s the right investment for the right level of evidence? Is there already evidence on similar products that they can use?

If so, are there still unanswered questions that indicate a research priority?’

Companies then have to grapple with the inherent demands of implementation: searching for sites and investigators; recruiting enough patients; and keeping the study on schedule. The issue that emerges most forcefully however is the overhead or ‘on-cost’ that Trusts charge as a percentage of each study’s total direct costs. In the UK this varies widely, ranging anywhere from 25% to 80% but increasingly tending to the upper end of the scale.

Consequently, UK overhead costs remain significantly higher than elsewhere in the EU. ‘In other European countries,’ said Mike Clancy, ‘you’re looking at a range of between 10% and 40% on-cost for devices studies.’ Both Mick Borroff and Janette Benaddi concur with this view. ‘Industry should of course pay where it incurs costs,’ said Janette, ‘but it shouldn’t pay over and above that. And when the NHS start consistently making charges that are inappropriately high, then studies start going overseas. Which is what we don’t want.’

Across the Channel ‘The French have a system of regional laboratories to carry out evaluations of devices. So Lyons, for example, hosts the Centre that deals with beds and mattresses and pressure area care. They examine your evidence, and if it’s acceptable they carry out an evaluation that credits you with a number of points.

But that approval then applies throughout the French health system – as opposed to here, where every Trust will want their own evaluations/evidence and there’s an awful lot of replication going on.

‘And of course each Centre develops expertise in its own right, building up collated feedback that informs their input. In places like Montpellier, which has worked to set itself up as a medtech base, the University attracts undergraduates and postgraduates to work in collaboration with the regional Centre. They’re given contracts of one to three years to be available for exactly that kind of work.’

Mike Clancy, Frontier Therapeutics

As part of its ‘Best Research for Best Health’ programme, the National Institute for Health Research (NIHR) is responding with improved services and support for device studies.

Since 2005 six NIHR Clinical Research Networks have covered specific highpriority areas of care. To these the NIHR has now added the Comprehensive Clinical Research Network. Open since April 2009 to both investigator-instigated and industry-sponsored studies, this covers all therapeutic areas, and is implemented through 25 regional centres throughout England as Comprehensive Local Research Networks (CLRNs). For studies adopted into the CLRN portfolio, the service includes initial feasibility studies within a given period; support with site searches and recruitment; and a clear route through the trial process to agreed goals and timelines.

To be adopted, an industry study must have a valid research question and a well-designed trial protocol already in place. Where design is concerned, finding out what evidence is already available is essential to shaping the final study. Here there is already a prime NIHR resource: its Centre for Reviews and Dissemination (CRD) website. Run from York University, the site is itself something of a triumph of user-friendly design. By simply typing in the term for a given technology, the user can instantly access and download published HTAs (over 8000 of them) and other evidence reviews from around the world.

Meanwhile the new model Clinical Investigations Agreement (mCIA) is now in use. A medtech counterpart to the model Clinical Trials Agreement developed for the pharmaceutical industry, the mCIA is a ‘generic’ contract covering not just RCTs but all kinds of study. If unmodified it can serve for any NHS site, drastically cutting the bureaucracy of site-by-site agreements. After its release less than a year ago following extensive consultation, feedback to date is positive. ‘It shows signs of doing the job it was designed to do,’ said Mick Borroff, who was closely involved in the consultation. ‘You can certainly now go to a Trust and say, “here’s the model UK agreement, we don’t want to modify it,” and then you can get Trust approval

much more quickly. That is now having an effect.’

Another important innovation, the Integrated Research Application System (IRAS), now streamlines research permissions and approvals. Through this single on-line portal, information for multiple applications need be entered only once. Led by the National Research Ethics Service (NRES), the system is effective UK-wide. IRAS partners include the MHRA and NHS Research & Development, and is also the entry point for the Co-ordinated System for NHS Approvals in England (CSP). Again the reception has been positive since its introduction 18 months ago, and from April 09 NRES made IRAS the preferred system for all its applications.

Still in development is NIHR’s newest Industry Costing Template, designed for use with studies adopted into the CLRNs. Similar to that already in use for pharmaceutical and biotech companies, this latest version is being piloted for the medtech industry. ‘Its purpose,’ said NIHR Director of Industry, Clare Morgan, ‘is to ensure consistency in the way commercial

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Within the Template, hourly rates for staff time specific to a study follow published rates on the Department of Health (DoH) website. Charges for ‘investigations’ – standard NHS procedures from blood testing to CAT scanning – are set by an Investigations Index based on averaging the variable charges made by individual English Trusts. Overheads are charged at 70% of direct costs (i.e. of staff and investigations costs.) A 20% charge is levied on direct costs to support capacity building, and each Trust has been given its own DoH ‘multiplier’ to account for geographical cost variations. (Full details are available at www.crncc.nihr.ac.uk/index/industry.)

‘The Template certainly breaks down the process into discrete steps with costings against each,’ said Mick Borroff. ‘So I think it does to a large extent achieve its aims of consistency and transparency. But overheads are set at 70% and I still feel that’s too high a percentage – it’s nearly doubling the costs of your study.’ Janette Benaddi and Mike Clancy share this opinion; the pilot Template is however currently undergoing further testing via real-time studies in the NHS by a number of devices companies, so it is by no means finalised.

Although designed primarily for studies adopted by CLRNs, the final Template could well be taken up more widely as a useful model to follow, or even an endorsement of the figures it proposes: ‘There’s a lot of uncertainty about that in sector,’ said Janette. So there is a good deal of interest in the outcome from medical device manufacturers.

The NIHR is keen to receive feedback and has set up a dedicated email address, crncc.costingfeedback@nihr.ac.uk, where people can give their views.

Meanwhile as part of the Next Steps Review initiated by Lord Darzi, work has begun on a new ‘Single Evaluation Pathway’ that aims to extend the range of devices evaluated for the NHS and ease their access into the system.

studies are charged for throughout the CLRNs, and to provide a transparent breakdown of all study costs.’

The Pathway will essentially incorporate the activities of the current Centre for Evidence-based Procurement (CEP) into the National Institute for Clinical Excellence (NICE). NICE already undertakes medical technology ☞ 7

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evaluations, focusing particularly on devices likely to have a significantly beneficial impact on the NHS. Mirella Marlow is the Associate Director of the NICE Interventional Procedures Programme, which assesses innovative surgical procedures and the devices involved. She is closely involved in developing the new system: ‘This is about establishing the value of medical technologies to the NHS,’ she said, ‘and the Pathway will simplify their access to evaluation. Instead of there being several potential entry points, manufacturers will be able to notify their product to just one place, and we will then decide how best to evaluate it.’

As yet in its earliest stages, the system is designed to be open to a broader range of devices, and that includes those with a lesser evidence base.

‘There may be Class I products for example,’ Mirella continued, ‘that would offer major benefits to NHS, but would not currently qualify for assessment under a NICE technology appraisal. Those appraisals demand a substantial evidence base, sufficient for us to recommend to the NHS that it must implement that technology within three months. So that’s a high hurdle.’

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that can serve evaluation further down the line.’

To support this broader remit, work is already underway in developing new methodologies to augment the effective evaluation of devices. MATCH (Multidisciplinary Assessment of Technology Centre for Healthcare) is a research collaboration of four universities, working both to create methods for assessing value and to make existing methods more accessible.

It has already developed a number of assessment tools for the medtech industry, and its work is feeding into the Pathway.

One of the MATCH areas of interest is how to evaluate a device’s lifetime effect on service delivery. NICE is just as aware as manufacturers of its importance: ‘Establishing [a device’s]

Equally, should a device look very promising but need more data about its use in clinical practice, NICE would look to advise on that in its recommendation. This is part of the Pathway’s aim to clarify for manufacturers the kind of evidence that they need to supply for their products. ‘We know that devices are different from drugs,’ said Mirella, ‘and we’re not in the business of encouraging costly investment in RCTs if there are other effective ways of demonstrating benefits in use. But we do want to make sure that if people are doing research, then it is of the kind 8

Such challenges are part and parcel of developing the new Pathway, and not the least of them will be that of developing criteria for selecting the entrants. This is a single Pathway, not a universal one: it’s not feasible for NICE or indeed any one body to evaluate all available medical technologies.

Choices therefore have to be made as to which products are suitable for assessment. ‘The definition of suitable products is being worked on now as part of the establishment of the Pathway,’ said Mirella. ‘It will not be restricted to “big” technologies, if by this we mean major national policy priorities like heart disease.’

The work on research and evaluation addresses some long-standing problems with establishing evidence for medical devices, though much remains to be done.

There is a clear consensus among devices companies that overhead charges for clinical studies are generally set too high. This was a point that industry representatives made strongly during Office for Life Sciences (OLS) consultations, when the OLS was developing its Blueprint report on what the sector should address in order to emerge in a stronger position postrecession.

By the same token, lowering this barrier to bring in technologies with a thinner evidence base means that establishing the value of a device would be a more conditional judgement. ‘So in these cases,’ said Mirella, ‘we could still advise the NHS as to the benefits of the product, but without the proviso that they should adopt it within three months.’ Even non-mandatory recommendations would nevertheless come backed by NICE’s formidable international reputation – a significant asset given that UK-wide, Trusts still vary in their acceptance of evidence. value,’ said Mirella, ‘cannot be separated from its impact on service delivery.’ Nevertheless, this is often not reflected in current NHS procurement decisions.

‘To me,’ said MATCH investigator Prof Terry Young, ‘evidence is all about making rational decisions. But those that are least rational are often the ones easiest to justify – such as, “this is cheaper than that”. To correct this, you have to both quantify service delivery impact and then reinterpret it into an economic model. Another issue is that you are often looking at evidence from the process-based side of care delivery.

Development of such guidance is therefore probably best approached on a region-by-region basis.

How do you evaluate that, as against what clinicians are more comfortable with – which is, “we’ve got an RCT that shows A works better than B?” Bringing those two worlds together is a real challenge.’

‘In the final report,’ said Mick Borroff, ‘this point was included but didn’t come through as strongly as we’d hoped. People I think are looking for government to take a lead in terms of principle rather than legislation. The fact is that these overheads are higher here than in other countries and in the UK there seems to be a trend to push that figure upwards. We’d like to see

In addition, Wales, Scotland and Northern Ireland of course differ in their NHS structures from England.

Nevertheless the needs of their devices manufacturers for improved clinical

that trend reversed, because it is really key if the UK is to be competitive as a base for clinical research.’

It’s also beginning to be recognised – and this has come through from companies large and small as well as government agencies – that there is an unmet need for practical, industryfocused guidance on clinical studies for individual companies. This is particularly important for SMEs – some of the smallest of which are also some of the most innovative – who may have limited or no experience of the process.

But even larger companies could benefit from support that effectively ‘looks both ways’ towards businesses and clinical studies experts.

Initial signposting to the right professionals is badly needed, and is certainly key to good design – not least in that it can open routes to implementation such as CLRN services.

In the view of Jill Dhell, Innovation & Industry R&D Relations Manager at the DoH, this support interface would ideally provide continuity of contact through the process when needed. ‘I think a key role would be for advisors to keep ownership of a project,’ said Jill, ‘so that if there are problems the company can return for further help.’

The new Health and Medicines KTN, the Medilinks organisations and the NHS Innovation Hubs could all be seen as likely bases for this kind of guidance, since they already sit at the crossover point between industry and the NHS. As however the regional networks vary considerably from region to region in terms of resources and capabilities, so would their potential for developing this additional function, which would bring its own resource demands.

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studies services, processes and guidance are comparable. The way is open for these regions to develop their own customised response, and current English initiatives offer a substantial basis from which to explore their options.

Coralie.palmer@mediwales.com

Centre for Evidence-based Medicine

Centre for Research & Dissemination

Web: www.cebm.net

Web: www.york.ac.uk/inst/crd

Mick Borroff

Industry Costing Template

Director Strategic Health Outcomes DePuy International Ltd Tel: 0113 387 7910 Fax: 0113 387 7887 Email: mborroff@its.jnj.com Web: www.depuy.com

Email: crncc.costingfeedback@nihr.ac.uk Web: www.crncc.nihr.ac.uk/index/industry

Oliver Wells Chairman, Research & Innovation Policy Group ABHI 111 Westminster Bridge Road London SE1 7HR Tel: 020 7960 4360 Fax: 020 7960 4361 Email: enquiries@abhi.org.uk Web: www.abhi.org.uk

Mirella Marlow Associate Director Interventional Procedures Programme NICE MidCity Place 71 High Holborn London WC1V 6NA Tel: 0845 003 7780 Fax: 0845 003 7784 Email: nice@nice.org.uk Web: www.nice.org.uk Prof Terry Young

Managing Director UK Frontier Therapeutics Newbridge Road Industrial Estate Blackwood NP12 2YN Tel: 01495 235800 Fax: 01495 235808 E-mail: info@frontier-group.co.uk Web: www.frontier-group.co.uk

MATCH School of Information Systems, Computing & Mathematics St Johns Building, Room SJ012 Brunel University, Kingston Lane Uxbridge Middlesex UB8 3PH Tel: 01895 266051 Fax: 01895 269727 Email: match@brunel.ac.uk Web: www.match.ac.uk

Janette Benaddi

Jill Dhell

CEO Medvance Ltd Medvance House Burn Grange Doncaster Road Burn, Selby YO8 8LA Tel: 01757 270044 Fax: 01757 270055 Email: Web: www.medvance.co.uk

Innovation & Industry R&D Relations Manager R&D Directorate Department of Health Wellington House 133-135 Waterloo Road London SE1 8UG Tel: 020 7972 1265 Email: jill.dhell@dh.gsi.gov.uk Web: www.dh.gsi.gov.uk

Mike Clancy

Clare Morgan Director of Industry NIHR Room 132, Richmond House 79 Whitehall London SW1A 2NL Tel: 0113 3430331 Email: crncc.industry@nihr.ac.uk Web: www.nihr.ac.uk

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Leading the Field In March this year the health technology sector’s most outstanding companies received the red-carpet treatment at Haberdashers’ Hall in London, venue for 2009’s Medilink UK National Health Technology Awards.

Sponsored by Xiros plc, the annual Awards showcase the cream of the country’s healthcare industry, celebrating leading-edge technologies, exceptional business achievements and international collaboration and success. The nominees for each of the five awards – Export Achievement, Innovation, Growth in Sector, Partnership with the NHS and Start Up – were made up of winners from the regional Medilink Awards selected by a panel of sector specialists from the 12 UK regions.

Winner of the Innovation Award was Birmingham-based The Binding Site Ltd for its development of Freelite.

This unique immunoassay is used for the diagnosis and monitoring of multiple myeloma cancer cells found in bone marrow. Such has been its impact that national and international guidelines on the treatment of multiple myeloma now include Freelite results as a requirement for monitoring the treatment of patients. In rare forms of the disease, monitoring with Freelite is the only way of assessing whether a patient is responding to therapy or if the therapy should be changed. In this group of patients the Freelite assay has revolutionised the way doctors can select appropriate treatment for each individual.

The Binding Site Ltd., winner of the Innovation Award Tel 0121 436 1000 , Web www.bindingsite.co.uk

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The Export Achievement Award was won by Inditherm Medical for their outstanding performance in international trade. Yorkshire-based Inditherm specialises in the design and manufacture of heating and warming products that are used in operating theatres, recovery rooms, A&E departments and delivery suites throughout the world. Using unique, carbon-based polymer technology the company aims to cut the costs of traditional heating as well as reducing carbon emissions: in particular, its products can significantly reduce the costs of preventing intra-operative hypothermia. Over the last year the company has increased its export sales by a staggering 338%, 80% of which increase has been generated by accessing new markets.

Inditherm Medical, winner of the Export Achievement Award Tel 01709 761000, Web www.inditherm.com

Tynetec Ltd won the Growth in Sector Award. Based in Northumberland, the company designs and manufactures social alarms, telecare sensors and access control systems. Trading since 1979, Tynetec has a long tradition of developing innovative, market-leading products that promote independent living: now a veteran of three previous recessions, its R&D investment has been consistent even through the most difficult periods. Dedicated to highquality production, the company’s entire product range is designed and manufactured in the UK using state-ofthe-art technologies. In 2008 Tynetec increased its turnover by 29.9%, combining strong business strategy with product innovation and customer partnership.

Tynetec Ltd, winner of the Growth in Sector Award Tel 01670 352371, Web www.tynetec.co.uk

The Research Start-Up Award was presented to Nottingham-based 4FX Healthcare Ltd. The company began with its award-winning baby nasal aspirator, designed to safely clear congestion from babies’ noses. The device works by using controlled mouth suction to remove congestion into a chamber containing a hygienic filter.

The product is now stocked in Mothercare stores at home and abroad, as well as in Sainsbury’s, Waitrose and other leading high-street outlets. A range of new products has been added to the company’s output, all with the theme of babies’ wellbeing in common.

Since its inception in 2006 the company has doubled their turnover, increased profit by 217% and last year won the Queen’s Award for Enterprise.

4FX Healthcare, winner of the Research Start-Up Award Tel 01623 827945, Web www.4little1.com

Finally, the Partnership with the NHS Award went to Home Telehealth Ltd. From its base in Cardiff, the company delivers UK-wide telehealth services and products for patients with long-term chronic conditions, allowing these often vulnerable patients to be cared for in a setting of their choice. Through a successful collaboration with Northern Ireland’s South East Trust (SET), the company’s specialists were able to deliver a new concept in fully-managed telehealth care which resulted in a decrease not only in hospital admissions, but in the number of hospital beds used, the length of time patients stayed in hospital and the number of visits made by GPs.

Home Telehealth, winner of the Partnership with the NHS Award Tel: 029 2044 4795 Web: www.hometelehealthltd.co.uk

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H E A LT H T E C H N O L O G Y I N T H E U K

The Voices of Industry report submitted in July to the Office of Life Sciences addresses some of the most significant issues facing the sector, and makes specific recommendations.

s k a e p S y r t s u d t In n e m n r e v o G to In April this year, the Government and the Treasury confirmed that life sciences make up the largest sector of the UK’s GDP. Comprising medical technologies, healthcare, diagnostics, pharmaceuticals and biotechnology, life sciences lead the three most important drivers of economic growth, followed by renewable technologies and the digital economy: it is these industries that will enable Britain to trade its way out of recession.

With this in mind, the Office for Life Sciences (OLS) committed to delivering tangible investment and support for life science companies within the following 12 months. As part of extensive consultations, the OLS called for industry to examine what government could do for SMEs in particular, both to stimulate investment and improve access to finance. This was the spur for the Voices of Industry campaign, launched by Medilink West Midlands (MedilinkWM) on 1 June 2009.

To co-ordinate industry response, the Medilink created a virtual ‘speaker’s corner’ via a dedicated internet microsite.

Users could email, post or phone in their comments, all of which were available on the site throughout the campaign to generate further debate and measure public support for ideas. The site pulled in opinions and proposals from companies of all sizes, from SMEs to multinationals, across the UK. At the end of the month-long campaign, MedilinkWM brought together CEOs, entrepreneurs, investors, academics and health professionals at a top-level ‘round

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table’ that represented a cross-section of the life sciences industries. The group sifted through every idea generated by the campaign, exploring its potential and implications in depth.

The findings were concentrated in a report to the OLS that made specific proposals for action, with detailed recommendations supported by comments from contributors to the debate. The report aims to assist the OLS in implementing the Blueprint it launched in mid-July, and to inform the policy on life sciences SMEs at BIS (department of Business, Innovation & Skills) that is now developing under the auspices of MMTSG. As suggested by the OLS itself, MedilinkWM now maintain the microsite for feedback and information from both industry and government on subsequent developments. Already firmly established as a popular forum, the microsite retains its ‘speaker’s corner’ format and is open to users as a long-term resource for raising every kind of issue and exploring solutions.

Summarised opposite are the findings of the report under its four major themes of Innovation, Overseas Trade, Finance and Expertise. You can see the complete list of comments and suggestions – and add your own voice to the ongoing debate – on the microsite at

www.medilinkuk.com/voicesofindustry

INNOVATION: The unique system developed to “push” and “pull” innovative means of infection control into the healthcare system has been a success, and should be replicated for all clinical practice areas.

The NHS has a world-leading reputation for the excellence of its clinical trials and validation.

But a cultural shift to early adoption of the new technologies would allow the power of that validation to unlock other markets for British manufacturers around the world.

One idea is to make time and incentives available to practitioners to explore innovation, so that they are both more aware of and receptive to new technologies in development or close to market.

But the system has to communicate with itself.

Once it has found something that represents best practice, it should be able to disseminate that new technology/product/service to other NHS locations. One of the roundtable participants told of a new Director within the NHS who, having joined from Tesco, was baffled to find that new ideas were adopted in one location but not spread NHS-wide - a dissemination process Tesco actively employs to ensure economies of scale.

The newly-launched Commercial Support Units (CSUs) should champion this culture change.

The established National Innovation Centre and Innovation Hubs should likewise facilitate earlystage innovation.

OVERSEAS TRADE: Eliminate the duplication and bureaucracy inherent in overseas promotion of UK companies: invest those savings into a grant companies can access for overseas approval documentation and practical market access.

FINANCE: Create a mezzanine finance scheme with minimal conditions, managed by people from within this sector, as a low-risk method of encouraging UK product development, UK patenting and UK innovation commercialisation.

The positive message of a single vision, articulated in the newly launched marketing strategy for Life Sciences, has buoyed industry morale. Rather than focusing on government interdepartmental concerns and letting regions compete, this single voice approach should create economies of scale when promoting the UK overseas.

Industry needs financial assistance, and is willing to pay that money back – it’s the immediate access which is the challenge.

Grants can be beneficial, but are increasingly becoming over-bureaucratic and poorly run with not enough return for the time investment.

Venture Capital investment only accounts for 5% of overall finance within life sciences, and the larger financial institutions are now too riskaverse to consider business loans.

The cost savings reaped by eliminating duplication should be reinvested into more practical, real life support for companies.

When accessing overseas support, the burden of paperwork and procedures is a common problem that needs to be addressed immediately. Fees for approvals documentation in each country represent a significant cost: this should be reduced by making a grant available to cover market entry costs and approval documentation.

Therefore, along with simplification of grants and continued support for venture investment, we see a solution as loans targeted specifically at life science businesses managed by life science professionals (who understand the needs of businesses seeking short-term loans) providing a mezzanine finance scheme.

The Enterprise Finance Guarantee Scheme (previously small firm loan guarantee scheme) has the right qualities SMEs are looking for, but is hampered by too bureaucratic an application process, while the limited providers are not offering companies what the scheme promises.

SMEs to multinat ionals SMEs t multina o tionals

to s E M r a isninaglsissue S o i s , t a n e i x t p l l o u r i n m raising is g solutions exploring sues, solutions

The R&D tax credit again is a scheme that interests SMEs, but the definition of ‘Development’ is too narrow. One company was only able to match £27k of their £150k R&D spend: match amount is capped by PAYE which is not always reflective of true development investment.

The Government has tried to address the issue of working capital by launching three Capital for Enterprise Funds, but only those companies which constitute the least amount of risk are eligible and this scheme is due to finish by the end of 2009.

What is needed are sustainable, commercial, longterm initiatives.

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EXPERTISE: Facilitate a single UK focus of life sciences expertise, which companies can access to reduce trialand-error time lost in the early stages of company development, harnessing the knowledge within larger UK companies and multinationals for the benefit of UK SMEs. A company can spend a minimum of two years trying to find its way through this marketplace, using trial and error. Enabling access to the correct expertise from the start, whether it’s advice on materials, design or even regulatory issues, would be a positive intervention.

A single focus for UK expertise would streamline a company’s journey into the market, reducing time and costs. By harvesting all the knowledge that resides within the regions, the multiple government agencies, the larger UK companies and multinationals, a national centre of expertise would be of great benefit to UK SMEs. By leveraging the work of the Innovation Hubs, industry could also gain access to relevant clinicians and practitioners, and the Hubs should be encouraged to use UK industry for commercialising ideas.

Within the NHS, a complex landscape and fragmented support systems act as barriers to accessing the correct type of expertise. On the private sector side expertise is organised regionally and/or departmentally and no-one has all the answers.

Accessing knowledge is further complicated by university activity in this area that needs to be clarified. Much university R&D is of great benefit to SMEs, but should not hinder solutions by clouding private sector business support or competing with industry vis à vis design etc.

Access to public funds by universities should be closely monitored to ensure it is not used for commercial activity.

realis potent rea g l ising n i s i l a re potteia lti n n e al pot

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Regional Roadshows Wales North East West Midlands

21st Jan City Hall Cardiff 28th Jan CELS Newcastle 2nd February Think Tank Birmingham

East Midlands

3rd February Bio City Nottingham

Yorkshire & Humber

17th Feb Science Park York

North West Scotland Northern Ireland

22nd Feb BioIncubator Manchester (includes North Wales) 24th Feb Dynamic Earth Edinburgh 25th Feb Invest NI building Belfast

East of England

3rd March Churchill College Cambridge

South West

9th March Bailbrooke House Bath

London South East

23rd March Wellcome Trust London 29th March Said Business School Oxford

Life Sciences Road Shows Join us at these free unique days of international business development and find out how you can input into and learn about the Office for Life Sciences' plans for the future of your sector.

The Office for Life Sciences (OLS) has brought

Alongside this UKTI will be running an interactive

together the UK Life Sciences industry with

programme which includes a range of workshops;

Government departments, working collectively to

• detailed market intelligence

maintain the UK’s pre-eminent position in the international Life Sciences industry.

• marketing workshop with additional one-to-one support

The commitments published in the Office for Life

• selling into the NHS

Sciences Blueprint are being actively implemented to

• exhibition training

benefit UK Life Sciences companies by a range of partners, including Department of Business,

• the challenge of China with a free exclusive 90 page Ernst and Young detailed report

Innovation and Skills, Department of Health, UK Trade & Investment, The Treasury, Regional Development

• accessing finance in the downturn

Agencies and Devolved Administrations.

• Life Sciences ‘Question Time’

Come along to your regional event to hear about the

• networking reception

latest update on progress with the OLS

* please note the topics may change for each event and places will be subject to availability

commitments, how this can make a difference to your business or organisation and the tools available to assist your marketing.

The Medilinks will be contacting all its members shortly with more details and how to register so book the date in your diary now

Register at www.olsroadshows.ukti.gov.uk

Contact us: Ian Bunker 0207 215 4851 ian.bunker@ukti.gsi.gov.uk

www.uktradeinvest.gov.uk/ukti/healthcare

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COMMENT

A fair trial in the UK

by Raymond Bratty

For some years now, it has been acknowledged that the UK’s contribution to industry-sponsored pharmaceutical trials has been shrinking.

The cost per patient and the start-up and recruitment times have become higher in the UK than in many other countries. In order to meet budget and timeline, patients are increasingly being sought elsewhere. The statistics are stark: up to 25% of UK sites fail to recruit any patient1, UK contribution to global patient enrolment has reduced markedly over six years2 and there is the news that one major global pharmaceutical company has recently decided to downgrade the UK to being a ‘non-core’ country in terms of trials3.

For the manager of a large international trial, centres that fail to recruit at all represent a significant setback. They will already have required site approvals (and country approvals), site assessment for suitability, site initiation visits, site master file/documentation, drug supplies delivery, and an agreement with the pharmacists. Recruitment problems may further demand several encouragement visits and/or ultimately a country investigator meeting, followed by the inevitable close-down visit. Sites that include just one or two patients and then stop recruitment are often less effective statistically, as each site produces more variability into the trial.

Collectively these problems add up to a huge waste of resources – not to mention erosion of the timeline, as the deficit in patients needs to be made up later.

Action is being taken at government and NHS level to reverse this trend. In May this year, the government’s response to the ‘Review and Refresh of Bioscience 2015’ report included a commitment to incorporating clinical research metrics – such as the number of patients recruited and the time taken for local research approval – in annual quality accounts produced by Trusts.

There will also be an objective to double the number of patients participating in clinical trials over the next five years.

Regional initiatives are also important.

For industry studies adopted into the NIHR research portfolio, the Northwest Exemplar Programme aims to demonstrate effective study set-up and delivery. The UK Clinical Research Collaboration has set up a number of clinical research networks designed to 16

the outset and queries dealt with at the time, which means there are no surprises later. Because all staff understand the rationale and protocol, appropriate staff can raise the issue of informed consent early – important in an acute study where a “consent window” is probable.

provide access to a large number of patients, including networks closely linked to the Northwest region. While it certainly makes sense to expand the number of potential patients available, experience indicates that this alone may not be enough to maximise recruitment.

In any trial there are the good recruiting centres and those that recruit one or no patients. How can it be that similarly sized sites, working with readily available and suitable trial subjects, exhibit such variable recruitment to clinical trials?

In the main, this appears to reflect the organisational culture prevailing at a given site. The best sites have a culture of continually doing important trials, whether on behalf of industry or academia, and demonstrate a cluster of practices contributing to their effectiveness. Firstly, all staff are included – physicians, nurses and ward staff – and they understand what is being done and why. The trials are either sequential or, if run concurrently, do so with safeguards to ensure that they do not recruit the same patients.

The protocol is carefully considered at

Further, pre-screening logs are enthusiastically kept in order to assess reasons for non-admission to the trial: these are checked later by the investigators to establish if they are making the right clinical predictions, with regard to inclusion/exclusion criteria. An important factor in acute trials is that on-call staff (covering a 24hour, seven-day week) are involved in recruiting, rather than only research staff who may be working a 40-hour, Monday-Friday week. And equally important, once patients have been recruited their data is entered into the given data entry system promptly and accurately.

These, essentially, are the characteristics of effective trial sites that the UK must offer to be internationally competitive.

Once trials go elsewhere it is easy to award future trials to the proven sites, so the UK needs to do even better than its rivals in order to reverse the trend.

We now have good, well-thought-out initiatives at governmental and regional level, both current and developing, that are vital in promoting that shift. But local support for sites to improve trial approval timeline, culture and infrastructure may also play an important part in benefiting recruitment and trial completion. It is arguable that a pilot initiative to take that role is well worth considering as a component in the developing strategy.

Raymond Bratty Head of Critical Care, Development Orion Corporation, Orion Pharma Tel: 0115 9487120/133 Email:raymond.bratty@orionpharma.com Web: www.orionpharma.com

1 Presentation by Dr Allison Jeynes-Ellis: ‘Clinical Research in the UK Today – a Brighter Future Beckons?’ (NIHR Clinical Research Network meeting 4.6 09)

www.ukcrn.org.uk/index/.../01/.../AJE_clinical_research_June09.pdf 2 Centre for Medicines Research: global patient enrolment 2000 to 2006 3 Pharmafocus June 15, 2009: ‘Scaling up the UK’s Research Ambition’

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PROJECTS

H E A LT H T E C H N O L O G Y I N T H E U K

screening application could be used by a less specialised practitioner such as a GP practice nurse, its data given as a simple immediate reading that indicates whether a colposcopy referral is needed or not. Both applications do away with the cumbersome process of sending samples for lab-based testing. This not only reduces anxiety for the patient, but cuts costs for the NHS.

Well Read A new diagnostics technology offers faster and more accurate results for cervical cancer testing, helping to reduce false positives.

The fruit of a decade of collaborative effort, the device is the brainchild of new medical devices company Zilico, based in Sheffield. Zilico is using the technology of Electrical Impedance Spectroscopy (EIS) to develop the next generation of cervical cancer diagnostics. Cervical cancer is the second most common cause of cancerrelated death in women: in the UK, with an established and effective screening programme, there are around 2700 new cases each year and 1000 deaths.

Initial screening for the disease involves the ‘smear test’, where a sample of cells is taken from the cervix. A positive test means referral to a colposcopist, who will make a detailed examination of the

1998

patient’s cervix to visually discriminate between normal, pre-cancerous and cancerous tissues. Most mild abnormalities that show up during colposcopy will go away, but physicians currently have no way of deciding which are self-resolving and which will progress to pre-cancerous lesions and then to cancer. Many physicians opt for a diagnostic biopsy, which to date is the only way to confirm a presumed diagnosis.

At present a significant number – up to a third – of women referred for colposcopy are subsequently revealed not to have the disease. Biopsy is an unpleasant experience in itself, even without the attendant anxiety of waiting for results. So for the many women who enter the system, any innovation that could improve cervical testing would be welcome. Zilico’s fully portable diagnostic device delivers realtime results with improved accuracy at both stages of the testing process.

NHS/University research

2000

Publication of first results in Lancet

2003

NHS NEAT grant award

The Zilico device is the end result of a collaboration going back to 1998, when Professor Brian Brown, Head of Medical Physics at the University of Sheffield, and John Tidy, a Gynaecological Oncologist at the Hallamshire Hospital, began to study the application of EIS to the detection of cervical cancer. An

The device has been developed as two applications, both using EIS technology: one is designed to support colposcopy, the other to replace the current cervical smear screening test. By measuring the resistivity of cells, EIS can detect changes as cells progress from normal to

2009

European multicentre trial started

2010 18

2013

Launch of colposcopy application in Europe

Launch of screening application

To complete this journey from diagnostic technology to marketable products, Zilico turned to Maddison product design consultants. Products for both applications will consist of a wireless, handheld device and a base unit. A single-use disposable sleeve will be used for every woman: by redesigning the product layout and configuration, Maddison enabled this without costly electronics having to be discarded at the same time. The first product launched will be for the colposcopy application, due in 2010.

Zilico intends to market its product range worldwide, targeting gynaecologists and other opinion leaders involved in the management of cervical cancer.

Richard Clark Chief Executive Medipex Icon Business Centre 4100 Park Approach Leeds LS15 8GB Tel: 0113 3970 840 Fax: 0113 3970 450 Email: Richard.Clark@medipex.co.uk Web: www.medipex.co.uk

Sara Calder-Jones Maddison Ltd Walnut Tree Yard Lower Street Fittleworth West Sussex RH20 1JE Tel: 01798 865711 Fax: 01798 865742 Email: sara.calder-jones@maddison.co.uk Web: www.maddison.co.uk

Wales’ largest bioscience conference, exhibition and biopartnering event.

17th and 18th March 2010

The Vale Hotel, Golf & Spa Resort, Hensol near Cardiff, UK*

and partners involved

Spinout from the Sheffield Teaching Hospitals NHS Foundation Trust and the University of Sheffield

AUTUMN 2009

BioWales 2010

3 clinical trials commence until 2006

2006

The following year the team approached Medipex, NHS Innovation Hub for the Yorkshire and Humber region, for help in translating its work into a commercially viable reality. The company was spun out in 2006 and Medipex has played a vital role in incubating its development, from providing interim project management and business planning to securing investment (from Exomedica Ltd and Medipex itself), and IP rights. Zilico has since sourced additional investment and Medipex is now a shareholder and board member.

Sameer Kothari Chief Executive Zilico Ltd The Sheffield Bioincubator 40 Leavygreave Road Sheffield S3 7RD Tel: 0114 222 4580 Fax: 0114 222 4551 Web: www.zilico.co.uk

2004

2005

initial prototype was produced in the workshops at Sheffield and a NEAT grant in 2003 enabled them to develop a more sophisticated device.

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precancerous and then cancerous. This means that testing will no longer be dependent just on the subjective process of visual assessment. Results will therefore be both more accurate, and more precise.

The colposcopy application will allow the physician to make an improved clinical decision and avoid unnecessary biopsies and treatment, while also pinpointing the location of any precancerous lesion or cancer. The

BioWales 2010 sessions will feature: ● Translational Research – what is it? ● Stem Cells – industrialisation for drug development and therapy. ● Point of care diagnostics. ● Cancer Genetics. ● Futurewatch – an introduction to what’s hot and new in bioscience today.

Biopartnering Event at BioWales 2010 Run by Enterprise Europe Network Wales and linked to the EU Enterprise Europe Network, the Biopartnering event provides a catalogue of high quality technology profiles and a base allowing one to one meetings to discuss partnering opportunities.

BioWales 2010 introduces the Welsh bioscience sector to an international, commercial, academic and NHS audience.

BioWales features : ● Presentations from innovative companies and academia ● Face to face partnering meetings ● Spotlight on bioscience exhibiting companies ● Workshops ● 2 days of networking opportunities Speakers for stem cell session include: • Stephen Minger, GE Healthcare • Nobel Prize winner, Professor Sir Martin Evans • Anthony H Davies, Geron Corporation

To make the most of BioWales 2010 register NOW at – www.biowalesevent.com *Just 2 hours from London, 30 minutes from Cardiff International Airport with ample free parking.

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PRODUCTS

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Securely Sealed A company with an innovative range of adhesive sealants for surgery has just launched a new partnership project.

Developed by Leeds-based Tissuemed Ltd, the ‘TissuePatch’ family of sealants augments sutures, staples and clips to create air- and water-tight seals during and after surgery. TissuePatch3, a fine adhesive film, is used in lung surgery to stop air leaks. Without an airtight seal, intake of ‘dirty’ air can lead to breathing difficulties, infection, prolonged hospital stays and even additional surgery.

TissuePatchDural is the family’s latest recruit. Used on the dura mater, the outermost and toughest layer of the membranes or “meninges” that enclose the brain, it is designed to prevent cerebrospinal fluid (CSF) leaking during brain surgery. ‘The dura mater,’ explained Tissuemed’s CEO Nick Woods, ‘is like a swimming-pool liner holding the CSF that the brain floats in. If there is a leak after brain surgery the dura typically doesn’t heal well, and this can lead to complications including meningitis. The patch helps stop this from happening.’

Pre-application, the TissuePatchDural looks like a piece of tracing paper. With zero preparation time, the patch only

needs 30 seconds of light manual pressure to ensure adhesion. Once in contact with the dura, the patch loses its papery quality and becomes transparent and elastic, rather like cling film.

Secured to the tissue surface, it looks and feels like a thin, flexible skin.

TissuePatch’s revolutionary qualities are evident when compared to their competitors. Firstly, these are the only true sealants that come in a patch form.

Before

Alternative liquid glues are susceptible to ‘run-off’ in use, reducing their efficacy. The patches not only eliminate this problem, but their conformability enables adhesion to uneven surfaces.

Secondly, their zero preparation time and negligible application time gives them the edge in terms of ease of use for surgeons. Their versatility of size also means that they can be fitted to each patient’s needs.

Post-market studies are currently underway for the TissuePatch3 and TissuePatchDural products. The latter is being tested in both the University of Bonn, Germany, and the Lapaz Hospital in Madrid. Both are observational studies, containing twenty-five and forty patients respectively. Due to be completed within the next two months, they are going well and the results to date are encouraging.

Tissuemed’s adhesive polymer platform technology could be developed in a number of ways for additional applications. Its multi-layer, multicomponent profile can have different characteristics “dialled in” as needed, to address the very specific demands of different surgical environments and

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Health-Centred tissue types. With this in mind, the company has launched a partnering initiative, the Tissuemed Adhesive Biomaterials Technology Group, specifically to foster collaborations with other medical companies.

The partnership aims to develop new products or adapt existing devices that may benefit from acquiring adhesive characteristics. Early discussions indicate potential applications with

After

meshes for hernia repair, or as a coating for other surgical devices where adhesive properties may be advantageous. In addition to its design capabilities, the partnership offers surgeons and companies support in areas such as intellectual property protection, physical and biochemical testing, and sales and marketing. ‘We recognise the fact,’ said Nick, ‘that although we’ve developed our own selfadhesive sealant film range, we can’t go it alone in all surgical niches. The partnership is a way of leveraging our technological capability and working with innovative thinkers outside our own group – in a way that can benefit all parties.’

Nick Woods CEO Tissuemed Ltd 5, Killingbeck Drive Leeds LS14 6UF Tel : 0113 200 0500 Fax: 0113 240 7343 Mobile: 07971 978774 Skype: nickwoods66 Email: nwoods@tissuemed.com Web: www.tissuemed.com

Two into One Goes Ahead Two of the UK’s Knowledge Transfer Networks (KTNs) are joining forces: the Health Technologies KTN will merge with bioProcessUK to form the HealthTech & Medicines KTN. Effective from 1 August, the merger follows the Technology Strategy Board’s 2008 Review of KTNs, which highlighted the value generated by these networks. Of more than 2000 users and R&D-intensive businesses surveyed, over half had developed or were developing new R&D collaborations or commercial relationships with people they had met through a KTN. The Health Technologies KTN was set up to promote innovation in the UK’s health technologies industries, working with Medilink UK. BioProcessUK has been providing similar support to businesses in the field of biological medicines processing. The Board’s Review identified shared areas of interest, many of them based on new and emerging fields and markets. By pooling activities in these areas, the new KTN can foster greater synergy between its members to drive commercialisation of the technologies.

Regenerative medicines are just one example: these include stem cell and tissue therapies, where the UK has a significant base of research that is poised for translation through to market and bedside. The new KTN will be active in many other areas that share convergence and the need for a multidisciplinary approach. Among them are the formulation and delivery of medicines; integration of health and social care delivery through the application of telehealth and telecare technologies; and supporting improvements in operational and manufacturing excellence, including supply chains.

The Healthtech & Medicines KTN will now build on these shared interests to create a far stronger single network, providing a single point of contact for the community. With this increased scale, the new KTN will be able to capture and exploit market pull more effectively, and in particular, to address unmet clinical need.

Further information at http://healthtech.globalwatchonline.com

New Shoots A new collaborative project is providing fledgling companies with the intensive support needed to commercialise groundbreaking inventions and scientific breakthroughs.

Launched in June, the Germinator Programme is delivered by Medilink East Midlands and BioCity Nottingham’s four East Midlands universities – Nottingham, Nottingham Trent, Leicester and Loughborough – are also supporting the project.

Three Leicester companies are among the first to be chosen for the programme. BioAstral Ltd is pioneering hyperspectral photon technology, including the use of fluorescence detectors in bioscience research. Gamma Technologies Ltd is developing advanced, hand-held miniature gamma ray cameras for use in surgery.

Spectral ID – a collaborative venture between the University of Leicester and PRCI Ltd – is developing technology to detect counterfeit drugs.

These organisations will receive both managerial and facilities support. ‘A common problem for new companies at the cutting edge of technology,’ explained Germinator Manager Dr Nick Gostick, ‘is that the inventors or research teams may have excellent technical knowledge and be able to learn essential business skills, but are

just not entrepreneurial enough.’ The Germinator solution identifies a “venture champion” with entrepreneurial flair and a proven business track record, who is then placed with the participating company for one day a week for up to nine months.

Now open to healthcare startups across the East Midlands, the Germinator also provides start-ups with an official headquarters either at BioCity, the Biobator in Leicester or Loughborough Innovation Centre. Here they can work from a prestige site with a full range of facilities that both links them to support networks and adds vital credibility when dealing with large companies and potential investors.

For information contact Nick Gostick by e-mailing n.gostick@biocity.co.uk.

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New Grounds for NanoHealth

Earlier this year the CNH secured £21.6million from the European Regional Development Fund, Swansea University, WAG-DHSS, NHS and private companies.

Believed to be the first state-of-theart NanoHealth facility of its kind in Europe, the CNH brings together the expertise of clinicians, life scientists, engineers and industry to develop leadingedge technologies and devices for the benefit of patients everywhere.

These are the technologies that will drive major advances in

healthcare. New projects already underway at Swansea include the development of an integrated blood sampling, bio-sensor and drug delivery system; an optical bioanalysis system; developments in printing biological components, and the ability to upscale device manufacture through printing technologies; and development of atomic force microscopy for clinical analysis in controlled environments.

The new open-access Centre will incorporate clean rooms for device fabrication, a bio-clean room for sensor functionalisation, nanocharacterisation labs, NMR & rheology, printing for bio-materials, molecular biology, tissue culture and tissue engineering, microbiology, and an advanced cell imaging suite. Adjoining the Centre

will be a clinical trials unit, MRI facility, and mass spec labs, along with incubation space for companies wishing to work more closely with the Centre.

Completion of the Centre facilities is planned for early 2011 but CNH is already open for business. Both public and private sector organisations can work on collaborative R&D projects with CNH experts and access CNH platform technologies at Swansea, currently based at the School of Engineering’s Multidisciplinary Nanotechnology Centre and the School of Medicine’s Institute of Life Sciences. From here enterprises can also develop plans for future collaborations that will need the facilities of the completed Centre.

Further information via: Tel 01792 602985 Web www.swan.ac.uk/nanohealth

New Tricks for Clinical Access In April this year Northern Ireland opened its new £2million Clinical Translational Research and Innovation Centre (C-TRIC).

The purpose-built facility is designed to reduce both costs and time-to-market associated with R&D for innovative health technologies, medical devices and therapeutics. Based in the North West of Ireland, the Centre will act as a flagship for attracting investment through healthcare research and innovation to the region.

Jointly operated and supported by the University of Ulster, Western Trust and Derry City Council, the new Centre will facilitate clinical research and streamline new developments from the laboratory to the market place through a focused ‘bench to bedside’ approach.

As an incubation venture, C-TRIC will nurture new business ideas by providing rental workspace, top-range laboratory facilities and world-class R&D facilities for pharmaceutical, biotechnology and healthcare sectors. Six start-up firms are already set to move into it, with

activities focusing on cardiac devices, respiratory health, wound management and deep-cleansing technologies aimed at reducing hospital-acquired infections.

Meanwhile University of Ulster researchers are using C-TRIC in their work on the important Trinity, Ulster, Dept of Agriculture (TUDA) study on

the chronic diseases of ageing.

Forming part of the National Nutrition Phenotype Database Project, this crossborder collaborative study is collecting detailed clinical, lifestyle, dietary, genetic and biochemical data to investigate nutritional factors and genenutrient interactions in the development of cardiovascular disease, Alzheimer’s, osteoporosis and stroke.

‘C-TRIC links the University’s research to the clinical and research expertise within the Western Trust,’ said C-TRIC’s Dr Maurice O’Kane, who is both R&D Director at the Trust and C-TRIC’s CEO. ‘We hope the healthcare innovations that stem from it will have a role in improving the general health and well-being of the 290,000 people living in the Western region.’

For further information contact Barry Henderson, Business Development Manager on 07866 494573 Web: www.c-tric.com 22

AUTUMN 2009

In Embryo

Health-Centred

Funding has now been secured for Swansea University’s groundbreaking Centre for NanoHealth (CNH), and a launch event in June saw the unveiling of plans for the new facility.

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Heart to Heart

On the Rise A revolutionary method for continuously monitoring body temperature is behind a new product helping women to manage their fertility.

Developed by Cambridge University spin-out company Cambridge Temperature Concepts, the DuoFertility device is aimed at the onein-six couples who have trouble conceiving a child. By precisely measuring a woman’s basal body temperature (BBT), its sensor can detect the tiny temperature rise that signals ovulation. After only one month of use the device can even predict when ovulation will occur.

The DuoFertility temperature sensor is a 10p-sized rubberised disk attached under the arm: invisible to onlookers and barely noticeable by the wearer, it can be left in place for days or even weeks at a time, and will withstand normal movement, showering and friction from clothing. The sensor measures temperature 20,000 times every 24 hours with extreme accuracy.

These readings are stored internally and can be downloaded at any time onto a handheld wireless data reader, which shows variations and trends in temperature and also acts as a ovulation diary. A green light is triggered if the woman is going to be fertile in the next six days: the intensity of the light varies according to the likelihood of getting pregnant if she has sex that day, and it stays on if the woman conceives.

After excellent results from a user trial of couples with complex fertility history, the company is now making a novel offer prior to the retail launch of the product in 2010. A single fee will purchase the technology and unlimited fertility expert support for a year, and if this does not result in pregnancy, the company will refund the full amount. Couples can consult with fertility advisers on the product website before making any commitment.

Full details are available at www.duofertility.com and www.temperatureconcepts.com

A wearable innovative monitoring device is offering a radical alternative to current obstetric practice.

Developed by spin-out company Monica Healthcare and based on over 15 years of research, the Monica AN24 foetal maternal monitor is a world first. Its noninvasive wireless technology monitors the well-being of a mother and her unborn baby for extended periods of time and allows the mother to move around as normal.

Existing techniques such as ultrasound confirm the health of the foetus by recording the foetal heart rate (FHR).

They are not however very effective in uninterrupted monitoring over longer periods of time, and so have limited prognostic value as well as restricting patients’ movement. For the at-risk foetus, Doppler ultrasound FHR monitoring has to be repeated three or four times a day, sometimes more. The Monica AN24 provides a genuine alternative to this labour-intensive regime, allowing extended monitoring of FHR, Maternal Heart Rate (MHR) and Uterine Activity (UA).

The AN24 electrodes are positioned on the mother’s abdomen in a standard position for all pregnancies and can be left in place for three or four days before being replaced. Positioning and connection takes moments and monitoring begins at the touch of a button. Weighing only 100g and the size of a small mobile phone, the device is unobtrusive and can be left unsupervised to monitor both mother and foetus for up to 22 hours.

In hospital the Monica AN24 is ideal for obese mothers, the active foetus and as an alternative to conventional intermittent FHR monitoring for high-risk inpatients.

The device also provides a practical solution for care at home of low- and medium-risk patients, resolving many of the problems associated with conventional foetal monitoring both in the home and hospital.

Further information at: www.monicahealthcare.com 23

REVIEW

IN BRIEF

H E A LT H T E C H N O L O G Y I N T H E U K

Fast Track

●

AUTUMN 2009

Longlife Holding Fire

Eye to Eye

An innovative device is reducing the fire risk run by patients who need to use oxygen but continue to smoke.

conversations with referring clinicians and relatively low-quality imaging – often sent by courier, causing more delay.

An innovative IT product at Great Ormond Street Hospital means faster emergency referrals to its specialist paediatricians.

Just one example shows the product’s impact: ‘In a recent case,’ said Dr Padmanabhan Ramnarayan, consultant for the CATS team and a co-inventor of CATS-i, ‘a boy had been in a road traffic accident outside London and with the help of CATS-i we quickly determined that he had a windpipe injury. The child was brought to GOSH by helicopter and given life-saving treatment by our tracheal team.’

Named CATS-i, the product enables the Children’s Acute Transport Service (CATS) to share high-quality diagnostic imaging data on emergency patients with referring hospitals more quickly than ever before. CATS is a paediatric intensive-care retrieval service for the North Thames and East Anglia region, regularly used by more than 50 hospitals in and around London.

CATS-i allows pristine medical images to be transmitted quickly and reliably via an internet browser from any hospital in the UK to remote recipients anywhere. The images are losslessly compressed (i.e. retaining absolute image quality), secure and encrypted throughout, so patient

Developed by Cimar UK and Great Ormond Street Hospital for Children NHS Trust (GOSH), the new technology was successfully trialled for 12 months by the CATS team at GOSH. Previously, a quick assessment of diagnosis would depend on phone

Developed by Mansfield-based company BPR Medical, the FireSafe Cannula Valve is a thermal fuse that will stop the flow of oxygen in the

data confidentiality is uncompromised.

The user cannot send anything without a secure token issued by the CATS office each time.

event of a fire. Every year scores of such fires result in serious injuries and fatalities.

‘Often clothes or bed linen will become oxygen enriched and then ignite when the cigarette or some ash is dropped on it,’ explained the company’s MD Richard Radford. ‘The PVC in the face mask, or in the tubing that delivers oxygen to the face, can also catch light. The fire will use the PVC tubing as a conduit heading back towards the source of the oxygen – in most cases a high pressure cylinder.’

According to recent figures, around 80,000 emphysema sufferers in the UK receive oxygen at home and it is estimated that more than a quarter of these patients continue to smoke –

The CATS-i project was commended in the Innovator Awards 2008 run by NHS Innovations London, who recently brokered an agreement between GOSH and Cimar UK to distribute the service.

despite the risk to themselves and to people around them of fire or even catastrophic explosion. Anecdotal evidence suggests that the BPR valve has already saved dozens of lives and reduced the impact of fires, and the device is now mandatory in the UK for home oxygen installations.

The company is the only manufacturer of such firebreaks, and has now released a version of the device aimed at the hospital market. Sales have received a further boost with changes to the NHS Fire Code guidance, recommending that firebreaks be considered for every oxygen outlet as part of any fire risk assessment. Given that – like smoking – oxygen fires are an international problem, there is global potential for this product.

For further information contact Alan How on 0207 380 1701 or alan.how@nhsinnovationslondon.com

Short & Sweet The Scottish government has pledged further support for its award-winning Emergency Care Summary Service as part of the new e-health strategy for 2008-11.

Developed by NHS National Services Scotland, the electronic Emergency Care Summary (ECS) provides key medical information to 4,500 clinical staff working in out-of-hours centres, A&E departments and NHS24. Around 5.4 million people – 99% of the Scottish population – now have an ECS. One impetus for the project was the 2004 change to GP contracts, whereby local GPs were no longer responsible for out-ofhours services. A system was needed to make sure that out-of-hours care providers could access critical medical records, even when a patient’s surgery was shut. In an environment where patient information has historically been held in a very localised way, the ECS now provides highspeed access to concise, essential clinical data: recorded allergies, adverse drug reactions and details of prescribed medication, including repeat prescriptions.

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The ECS was designed to use stable, known technologies so that all vendors of GP systems serving the Scottish market could quickly make their software ECScompatible. As information is extracted only from these systems, GPs are effectively the gatekeepers. Patients can also review records, confirming that they are up to date.

The e-health strategy confirms the Scottish government’s commitment to

stick to its current incremental approach and build on the systems already in use in Scotland. “Big bang” approaches to ehealth are rejected as risky and potentially disruptive: ‘NHS Scotland has to date chosen to approach this vision step-bystep’ says the report, ‘by building on what we have already successfully achieved, carefully addressing risks and resources to gain benefit from our effort as we go.’

Moving On Electrical stimulation at a robotic workstation has helped stroke patients re-learn how to move.

The world’s first clinical application of these combined technologies, this pioneering system was developed in a three-year research project at Southampton University to successfully retrain arm movement in chronic stroke patients. Professor Jane Burridge, a specialist in rehabilitation technology, led a multidisciplinary team of researchers on the project, including physiotherapist Dr Ann-Marie Hughes from the School of Health Sciences and engineer Dr Chris Freeman from the School of Electronics & Computer Science.

The researchers adapted the technique of iterative learning control (normally used for industrial robots) to the challenges of rehabilitation. Their task was to discover whether electrical stimulation to contract appropriate muscles – received through electrodes attached to patients’ skin – could be controlled to enable them to successfully perform tasks. Stroke patients

attempted to track a moving target over a two dimensional plane by moving a joy-stick. Their movements were measured to detect the tracking error, and calculations made to adjust the level and timing of stimulation so that the error was corrected.

In the three-year study, the researchers first used the technology with healthy people to test the concept, and to generate data on the muscle activity that normally happens as people track a moving target. The system was then trialled with local stroke survivors: after 18 hours using the system, repetition improved their voluntary tracking and so gradually reduced the need for artificial stimulation.

Details of how the stroke patients’ muscle activity differed from healthy people, and how it changed over the course of the intervention will be presented at this year’s International Conference of Rehabilitation Robotics (ICORR 09) in Kyoto, Japan.

For more information please contact Dr Ann-Marie Hughes on 023 8059 5919 or email: A.Hughes@soton.ac.uk

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REVIEW

“At last, like minded people with enthusiasm!”

IN BRIEF

Caroline Pennington, BBSRC enterprise fellow, University of East Anglia

“Another outstanding partnering event. ERBI continues to grow and develop to refl ect its membership base. See you next year.”

Learning Curve Squaring the Safety Circle How do medical devices designers make products that are both innovative yet safe enough to get to market?

A team at Loughborough University’s Business School has been investigating this question as one of a series of studies sponsored by the Engineering and Physical Sciences Research Council (EPSRC).

Tarquin Bennett-Coles, Director RSA

Mastering Regulatory Affairs Cranfield’s new MSc in Medical Technology Regulatory Affairs (MTRA) means that for the first time, regulatory affairs professionals have a recognised way to formalise their skills in the field of medical technology.

In the first phase of the project, the team interviewed a range of stakeholders, including designers in SMEs and multinationals, as well as staff from the Medilinks, NHS Innovation Hubs and NPSA. Their responses indicated that there seem to be two major ways of approaching safety when developing new products. The first treats safety as rigid and non-negotiable, and the most important aspect of product development. The other approach sees safety as negotiated, complex, and one of many factors that must be taken into account in developing devices, along with cost, time, company resources and aesthetics.

Developed in collaboration with TOPRA (The Organisation for Professionals in Regulatory Affairs), the MSc is available on a parttime basis only and designed to be flexible in order to fit around students’ current job and responsibilities. For even greater flexibility, and for professionals with a specific interest, individual modules may be attended as stand-alone 3-day short courses. Those for 2009 include Principles of European Medical Technology Regulatory Affairs, on 22–24 September; and Design, Development and Testing of Medical Technologies, on 8–10 December.

In the next phase of the project, designers from SMEs, multinationals, universities and hospitals were asked how they went about solving specific design problems. Processes included prototyping, breaking the problem down in smaller pieces, brainstorming, and also involving clients in the process. Ideas were generated in many different ways, from assessing multiple solutions to challenging existing ones; sometimes they just ‘came out of the blue’.

Dr Sam Martin is Regulatory and Clinical Affairs Manager at Ranier Technology Ltd, and has recently completed each of the MTRA modules as short courses. ‘I chose to study these modules to help broaden and consolidate my knowledge in this area, for practical assistance, for networking and to boost my CV,’ she explained. The course underpinned Sam’s move into regulatory affairs, and helped to boost her standing both within Ranier and with all the regulatory professionals and agencies that she deals with.

Designers did not just change design parameters in order to solve problems, but also to change manufacturing and service processes, change suppliers, or how they communicated with users.

The research team are now analysing the data to examine how to enhance problem-solving during the design and development of medical devices.

For further information contact Professor Kevin Daniels on 01509 222720 or at k.j.daniels@lboro.ac.uk

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The structure of the course enabled Sam to manage the additional demands of further studying: ‘The length and format is ideal,’ she said, ‘just enough time to cover the ground at a pace without going into overload. I would strongly recommend the course to colleagues and others, whether as stand-alone short courses or as the complete MSc.’ For further information contact the Enquiries Team on 01234 758008, or via enquiries.health@cranfield.ac.uk or www.cranfield.ac.uk/health/med

Interims, RSA Consulting Limited “An excellent event, that I would happily recommend and would aim to attend next year.”

Sotiris Missailidis, Lecturer in Chemistry and Analytical Sciences, The Open University

2009 statistics > Over 500 delegates, 70+ overseas > Representatives from over 400 companies > 60+ companies from overseas > Delegates from 17 Countries attended

Partnering Highlights > Largest UK organised partnering event > 3 out of 4 companies participated in meetings > 18 countries participated including 15 multinationals > Over 4000 meeting requests

“Probably the most enjoyable way of combining business with learning that I’ve yet discovered.”

Brian House, Managing Director, Brainwave Media Limited

> Over 1000 meetings took place

For more information and to book, visit www.erbiconference.co.uk email conference@erbi.co.uk or call +44 (0) 1223 497 401

Save the date!

It pays to pull together

MedilinkUK

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

MedilinkUK Medilink UK Review Partners BioBusinessNI The Innovation Centre Northern Ireland Science Park Queen’s Road, Queen’s Island Belfast BT3 9DT Tel: 02890 737947 Web: www.biobusinessni.org ERBI Ltd Meditrina Building Babraham Research Campus Cambridge CB22 3AT Tel: 01223 497 400 Fax: 01223 497 415 Email: info@erbi.co.uk Web: www.erbi.co.uk HealthConnect Quorum 16 Quorum Business Park Benton Lane Newcastle upon Tyne NE12 8BX Tel: 0191 215 5025 Fax: 0191 215 5522 Email: info@bewellconnected.co.uk Web: www.bewellconnected.co.uk Health Tech and Medicines KTN c/o TWI Ltd Granta Park Great Abington Cambridge CB1 6AL Tel: 01223 899 000 Fax: 01223 892 588 Web: www.healthtechktn.com www.healthtechktn.com Web: www.bioprocessuk.org

Medilink East Midlands BioCity Nottingham Pennyfoot Street Nottingham NG1 1GF Tel 0115 912 4327 Fax 0115 912 4331 Web: www.medilinkem.com Medilink North West 36 Greenheys Manchester Science Park Pencroft Way Manchester M15 6JJ Tel: 0161 660 9480 Fax: 0161 660 9484 Email: enquiries@medilinknw.co.uk Web: www.medilinknw.co.uk Medilink West Midlands 4 Greenfield Crescent Edgbaston Birmingham B15 3BE Tel: 0121 452 5630 Fax: 0121 454 2325 Email: enquiries@MedilinkWM.co.uk Web: www.medilinkWM.co.uk

Medilink Yorkshire & Humber First Floor, Building 1 3 Smithy Wood Drive Smithy Wood Business Park Sheffield S35 1QN Tel: 0114 232 9277 Fax: 0114 245 6820 Email: n.alevizos@medilink.co.uk Web: www.medilink.co.u www.medilink.co.uk

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 Email: enquiries@southwestrda.org.uk Web: www.southwestrda.org.uk

NHS Innovations London 6th Floor, West Wing 250 Euston Road London NW1 2PQ Tel : 020 7380 1700 Fax: 020 7387 5540 Email: info@nhsinnovationslondon.com Web: nhsinnovationslondon.com

MediWales 7 Schooner Way Atlantic Wharf Cardiff CF10 4DZ Tel/fax: 029 2047 3456 Email: jess.fisher@mediwales.com Web: www.mediwales.com

The UK Health Technologies Business Network