MediWales Review - Winter 2007

M E D I W A L E S

Down but not Out: New Depression Treatment Seeing the Light in Pulse Oximeters A Fair Trial for Medical Devices

M A G A Z I N E

W I N T E R

2 0 0 7

T

H

E

M

E

D

I

W

A

L

E

S

R

The Shock of the New The profile of Welsh medical technology is coming into eversharper focus. In the growing sophistication of this maturing sector, innovation is not a rhetorical platitude but a working necessity.

This kind of profile means that the deployment of appropriate clinical trials is becoming ever more applicable. Increasingly, Welsh manufacturers of new medical devices are looking not only at the trials of safety and performance needed for CE marking, but at comparative trials to demonstrate clinical efficacy. In this edition’s Research Review we look at the particular issues concerning both kinds of trial for medical devices, while our lead story looks at a highly innovative Welsh technology that is the subject of new UK and US clinical trials.

Some new devices are not appropriate for clinical trials per se, but still require engagement with the clinical fraternity in their development – particularly if they are to be adopted by the NHS. This is a recurring theme among medical device manufacturers, especially (though not solely) SMEs, such as the company featured in our Product Review. MediWales continues to press for easier access to NHS evaluation groups and procedures, and our discussion of clinical trials references two available sources of guidance.

It has been the signal advances made in this sector that prompted our introduction of the MediWales Innovation Awards, given for the first time at a ceremonial dinner last November. We wanted to give due recognition to companies who have made an outstanding contribution to medical technology in Wales. The Awards reflect the sector’s increased engagement with policy-makers and influential groups throughout the UK, and we were pleased to welcome the Welsh Assembly Government’s Minister for Health, Dr Brian Gibbons, as our prizegiver. Details of all award-winners and their projects are given in this edition.

When it comes to innovative products, the system for NHS purchasing is a topic generating a good deal of (often heated) debate amongst our membership.

Sometimes new medical devices are more efficacious; sometimes they are as good, but simpler to use or offer long-term cost savings. Either way, even demonstrable benefit cannot always effect the adoption of new devices by the NHS. The next Spring issue of the Review will take a closer look at the principles and practice of procurement in the NHS as it affects medical devices, and at how the latest changes are likely to impact the Welsh medical technology sector.

E

V

I

E

W

W

I

N

T

E

2

0

0

7

Contents F E AT U R E S Down but not Out 4 Transcranial Magnetic Stimulation a new depression therapy

PRODUCT REVIEW Seeing the Light in Pulse Oximeters Vital sensor testing technology

13

Shaking the EU Money Tree 17 Accessing EU innovation funding

RESEARCH REVIEW A Fair Trial for Medical Devices 18 Making best use of clinical trials

AWARDS REVIEW MediWales Innovation Awards 22 Prizewinning people and products

NOTES REVIEW Letters, News, Events

27

“

Transcranial Magnetic Stimulation holds great potential as a tool for understanding how the brain works, correcting its dysfunctions and even augmenting its abilities.

”

Coralie Palmer Editor M E M B E R Cover image: Brain scan. Coloured magnetic resonance imaging (MRI) scan of a sagittal (side view) section through a healthy brain superimposed on a woman’s head. MARK THOMAS/SCIENCE PHOTO LIBRARY

R

E

A

T

U

R

E

S

T

Down but not Out

Brain pathways. Coloured 3-dimensional magnetic resonance imaging (MRI) scan of the white matter pathways of the brain, side view. White matter is composed of myelin-coated nerve cell fibres that carry information between nerve cells in the cerebrum of the brain (top half of image) and the brain stem (bottom centre).

depression is now fully ‘medicalised’. But analyses that predate modern medicine – describing what was then called ‘melancholia’ – can still be acutely perceptive, and in the absence of a specialised psychiatric vocabulary their language is vividly expressive.

The most comprehensive historical study must be that of 17th century English scholar Robert Burton, himself a sufferer. Published in 1621, the Anatomy of Melancholy is a half-million-word encyclopaedia

TOM BARRICK, CHRIS CLARK, SGHMS/SCIENCE PHOTO LIBRARY

1

For clinical purposes, depression is defined as a state of intense sadness or despair sufficient to damage an individual’s social functioning and/or daily life. Even within those terms the condition inhabits a wide spectrum of severity, and clinicians use structured questionnaires such as the Hamilton Rating Scale for Depression (HAM-D), or the Beck Depression Inventory (BDI), to assess how badly the sufferer is affected.

As these terms make clear,

E

M

E

D

I

W

A

L

E

S

R

E

V

I

E

W

W

I

N

T

E

R

2

covering every possible aspect of depressive states known at the time. It could also be reckoned the world’s first self-help manual: being written, as Burton explained, ‘that every man that is in any measure affected with this malady, may know how to examine it in himself, and apply remedies unto it.’ In his time as well as ours, what he called ‘the vile rock of melancholy’ (one senses the teeth gritting) was ‘a disease so frequent, few there are that feel not the smart of it.’

Coralie Palmer looks at our understanding and treatment of depression past and present, and at the therapeutic promise of a novel technology, Transcranial Magnetic Stimulation Depression is one of the oldest and most intransigent of human afflictions. From Classical times to the present, sufferers, sympathisers and observers alike have puzzled over the nature of what scientist Lewis Wolpert, from his own bitter experience of it, called ‘malignant sadness’.

H

Burton concurred with his vast array of sources that the origin of the disorder was clearly in the brain, and his definition of it still resonates: ‘Fear and sorrow are the true characters, and inseparable companions, of most melancholy,’ he observed. Some of the treatments he discusses, such as the bloodletting ubiquitous at the time, are famously futile. But he also charts practical remedies from clean clothes to exercise, from good company to music. In the closing pages of his vast compendium, he acknowledges that a cure remains elusive, but distils the essence of his advice: ‘Be not solitary; be not idle.’

‘miserable distemper’. The Doctor was a seasoned – indeed much battered – veteran of this particular struggle. As Boswell later confided to his journal, Johnson ‘…advised me to have constant occupation of mind, to take a great deal of exercise, and to live moderately; especially to shun drinking at night.

“Melancholy people,” said he, “are apt to fly to intemperance, which gives a momentary relief but then sinks the soul much lower in 2 misery.”’

Much the same approach was at work 140 years later, when we find literary lion Dr Samuel Johnson (compiler of the first English dictionary) and the young James Boswell (his future biographer) at the Turk’s Head coffee house in London, sharing for the first time their own experiences of the

From a modern medical perspective, these empirical remedies still comprise perfectly sound ‘behavioural strategies’ for managing depression – but only up to a point.

MRI scan of healthy brain

0

0

7

PHOTO: MICHAEL ABBOTT/WOLFSON BRAIN IMAGING CENTRE/MRICRO SOFTWARE

F

We know for example that exercise releases endorphins implicated in improving mood; and that alcohol, while initially stimulating, is in fact a depressant. And Burton’s final, sovereign injunction is directed with great precision at the inertia and self-isolation so typical of depression, then and now. But these histories also record the common experience that when depression became very severe and persistent, such strategies were for the most part ineffectual: the sufferer could only endure – or not.

Not until the latter part of the 19th century do we see the emergence of notably new approaches to the understanding and treatment of the condition. Freud’s groundbreaking work on the subconscious ushered in the psychoanalytical model that dominated psychiatry through to the Second World War, a period that

5

F

E

A

T

U

R

E

T

S

mystery. Nevertheless, advances in many branches of the related areas of study – including psychology, psychiatry, and cognitive neuroscience – offer routes to the synthesis of new data both about the workings of the brain, and the genesis and treatment of depression.

Here a novel technology, Transcranial Magnetic Stimulation (TMS), has not only proven a valuable research tool but is being studied as a promising potential addition to the range of depression therapies.

Coloured PET scan of depressed and normal brain Depressed and healthy brains. Coloured Positron Emission Tomography (PET) scan of the brains of a depressed patient and healthy patient. The left- side of the brain is seen, in external view. Colour-coded regions in red/yellow depict areas of low brain activity. At top, the depressed brain contains large areas in the prefrontal cortex (at left) and parieto-temporal (at right) with low activity. At bottom, the healthy brain treated for depression shows metabolic activity and blood flow has resumed in these affected areas. Depression is a disorder of varying severity resulting in sadness, hopelessness, and loss of concentration.

also saw the discovery of the first neurotransmitter in 1928 and the first use of electro-convulsive therapy (ECT) ten years later. In the post-war decades, these and other discoveries fed an accelerated growth in scientific understanding of the brain, which in turn informed developments in the range of

6

treatments available for clinical depression - most conspicuously in the dramatic expansion of drug therapies.

Our current understanding of the condition is still very far from complete: the human brain in many ways remains the ultimate scientific

WELLCOME DEPT. OF COGNITIVE NEUROLOGY/ SCIENCE PHOTO LIBRARY

Welsh company Magstim, based at Whitland in West Wales, is one of only three companies world-wide manufacturing this technology. It is also a leader in research into its therapeutic applications, and the company’s Managing Director, John Starzewski, described for me how it works, and what it can be used for.

The brain, he pointed out, is essentially an electrical organ. In TMS, specially designed electrical coils held close to the head send strong but very brief magnetic pulses to the brain that induce tiny electric currents in the subject’s neural circuitry. The placing of the coil determines which particular part of the brain is stimulated. So unlike purely electrical techniques (such deep brain stimulation and ECT) that involve the attachment or implantation of electrodes, TMS is both focal, in that it can be targeted at specific areas of the brain, and non-invasive.

TMS is used in the study of both normative and damaged brains. It can be delivered either as a single pulse, or as a set of rapid, repeated pulses – the latter known as repetitive TMS (rTMS). ‘A single

pulse of stimulation to the brain’s motor cortex,’ John explained, ‘causes the associated muscle to twitch. This means neurologists can use TMS to monitor nerve conduction in diseases such as stroke or motor neurone disease.

With rTMS, there is a much greater range of effects. Depending on the brain area stimulated, it can either elevate or depress brain function.’

In the view of Dr Mark George, Director of the Brain Stimulation Laboratory at the Medical University of South Carolina (MUSC), this capability ‘ holds great potential as a tool for understanding how the brain works, correcting its dysfunctions and even augmenting 3 its abilities.’

To realise this potential, part of the challenge for researchers lies in refining their knowledge of optimum placing for the coil. This is where cognitive neuroscience comes in, studying where in the brain mental processes take place.

The development of functional Magnetic Resonance Image (fMRI) scanners, which generate highresolution 3-D images of the working brain, has provided a powerful tool for exploring the question of which specific parts of the brain do what. The newly established Cardiff University Brain and Repair Imaging Centre (CUBRIC) will be at the forefront of research in this field, and has purchased both a TMS and an rTMS machine from Magstim.

‘Certain areas of the brain are strongly associated with certain functions,’ explained the Centre’s founding Director Professor Peter Halligan. ‘However individual variations are common – people are affected to differing degrees, for example, by having the same area of brain disabled by stroke. So we need to refine the localisation of brain activity.’ To do this, researchers can use rTMS to induce temporary ‘lesions’ in the brain,

H

E

M

E

D

I

W

A

L

E

S

essentially shutting down certain functions and then observing the effects. By applying rTMS within an fMRI scanner as subjects perform a task, researchers can know just where stimulation is occurring and can image the resulting changes in the neural circuitry.

From the mid-90s onward, researchers began to study the potential therapeutic effects on depressive subjects of both TMS and rTMS. At MUSC, Mark George was one of the earliest people to embark on this research. He focused on the prefrontal cortex of the brain, because as he described, ‘that region appears abnormal in many internal images of depressed patients and because it governs deeper limbic regions involved in 4 mood and emotion regulation.’

R

E

V

I

E

W

W

I

N

T

E

R

2

0

0

7

Research now gives some indications that depression is associated with lowered activity in the brain’s left dorso-lateral prefrontal cortex – in layman’s terms, the left front – with the equivalent area on the right front being associated with hyperactivity, as implicated in mania or psychosis.

The present consensus is that rTMS produces a statistically significant antidepressant effect. The magnitude of that effect is not yet clear, as Dr George Kirov, lecturer in psychiatry at Cardiff University’s Department of Psychological Medicine, explained: ‘There is a big range in these results. The confirmation of an anti-depressive effect is an important finding, but it doesn’t compare with the efficacy of ECT for example. You could say that it’s probably more on the level of the effect of antidepressants. But that in itself is significant, because this is drug-free treatment with virtually no side-effects.’

Touch-screen interface of ‘Magstim Rapid2’ rTMS machine

7

F

E

A

T

U

R

E

T

S

focuses on the dialogue with the self The rTMS findings to date also within a person’s mind, to diagnose reflect the range of options to be and re-work faulty ‘cognitions’ – considered when setting habits of knowledge and belief – parameters for use of this complex that can trigger and reinforce technology. These parameters depressive states. CBT has proven include intensity, frequency and to be an efficacious technique, often duration. Intensity represents the used in combination with longeroutput of the machine. Displayed term, appropriate drug therapy to on a dial, it’s expressed as a sustain improvements. percentage of voltage discharged when the The depression system is running pharmacopoeia is now at maximum extensive, with the most output. The recent major development frequency of an being the introduction of electrical signal is SSRIs, or Selective expressed as Hertz Serotonin Reuptake – cycles per second Inhibitors.

These remain a – and in rTMS this popular first option in will typically run at primary care but can be between 1-10Hz. replaced or augmented Duration refers to from a wide range of the length and additional drugs if patient intervals of the does not respond. In the treatment. A case of ‘drug-resistant ‘Magstim Theta’ MST treatment session machine depression’ however, might run for 20-30 patients do not respond significantly minutes in intervals of say five to any mix of pharmaceutical seconds of stimulation, followed by remedies. This problem still 25 seconds of rest. Add the exact positioning of the coil to these interacting variables, and it is not surprising that there is considerable debate as to how the parameters determine the effects in rTMS, and to what extent – questions that only further research can answer.

The potential applications for rTMS are indicated at different points along the current therapeutic spectrum, which in broad terms offers three kinds of intervention.

Of the non-invasive ‘talking’ therapies, Cognitive Behavioural Therapy (CBT) is one of the most widely used and can be beneficial even in the case of very severe depression. Usually short-term, involving some 6-12 sessions, CBT

8

‘Magstim Rapid2’ rTMS machine

constitutes one of modern medicine’s most significant challenges.

At present the last resort for such patients – for whom all else has failed, and where suicide may be a serious risk – remains ECT. This is a technique that, in many people’s imaginations, comes trailing Frankenstein-like horrors arising from pre-war films of its earliest

use. The dramatic convulsions they portrayed reflected intense brain activity, and it’s this brain activity that constitutes a ‘seizure’. But the modern treatment, while still inducing a seizure, does not produce convulsions. Patients now receive approximately a thousandth of the current formerly delivered, and do so under general anaesthetic with a muscle relaxant. This means their physical reactions are minor twitches rather than major spasms.

ECT has a high success rate as a therapy for severely depressed patients, with some 70% showing notable improvement. There are still drawbacks, such as the shortterm memory loss that is a common side-effect. This arises because ECT is delivered through electrodes attached to the skull, which spreads the current so that it cannot be focused on a particular brain area.

For George Kirov, this is not the major issue. ‘Although results are extremely good in the short-term,’ he said, ‘they are not necessarily sustained over time: just over half the patients subsequently relapse.

There have been very few studies done as to how to improve the longterm outcome.’

Now a new clinical trial is about to begin in the UK, testing a particular kind of rTMS that could offer an alternative to ECT. As part of Magstim’s R&D commitment, the company cooperates with leading researchers and institutions worldwide. It has particular collaborations with two centres in the US, Columbia University Medical Centre and Dallas South-Western. Through her research at Columbia, Dr Sarah Lisanby discovered that rTMS at a high frequency could induce a seizure comparable to that in ECT, with indications of beneficial

H

E

M

E

D

I

W

A

L

E

S

R

E

V

I

E

W

W

I

N

T

E

R

2

0

0

7

therapeutic effects – but it did not appear to produce the associated short-term memory loss. The task was then to explore the therapeutic potential of this particular type of stimulation, termed Magnetic Seizure Therapy (MST). Both at the US centres, and at two centres in the UK, clinical trials will now be testing MST. In the UK, the trials are being undertaken at sites in Edinburgh, under Dr Allan Scott, and at Whitchurch hospital in Cardiff, under Dr Kirov. At the Cardiff site they are in the process of recruiting 32 severely depressed patients.

‘The aim of this study,’ said Dr Kirov, ‘is to work out the best parameters for delivering this treatment. There will be two arms in the trial, comparing two sets of parameters for the treatment to see which are the most effective and safe.’ Patients will be randomised between those two arms, and they will be ‘blind’ as to the parameters.

Once this study has clarified the optimal parameters, the researchers will be in a position to seek consent for the next and most important step: a clinical trial comparing the outcomes of MST with those of ECT, to see whether MST can deliver equivalent therapeutic benefits but without the side-effects.

Dr Kirov is also keen to see more research work done with rTMS, using different parameters with patients from a range of depressive states.

‘I think the potential is huge,’ he said. ‘As a non-invasive treatment, it could have value in cases of depression in pregnant women, where drug therapy is inadvisable, as well as with post-natal depression. It also might offer a means of preventing post-ECT/MST

‘Magstim 2002’ TMS machine in use

relapse through follow-up rTMS.’ Equally, in his view, there is potential for studying rTMS given in conjunction with either drug therapy or CBT, as opposed to those treatments without.

The possibilities are then considerable, and Magstim continues to work on developing the technology itself in terms of ease of use, refined precision and greater power. This will demand more research and development, in relation to the physics and engineering of the machine; the localisation of the site of depressive disorders in the brain; and the extent of therapeutic effects over a range of depressive conditions.

Magstim is working to build on

1 Wolpert, Lewis: Malignant Sadness: The Anatomy of Depression (Faber-new edn. 2006) 2 Ed. Frederick Pottle: Boswell’s London Journal 1762-1763 (Reprint Society 1952) 3 George, Mark S: “Stimulating the Brian’, Scientific American Sept 2003 4 Ibid.

existing collaborations and to establish new ones across the related disciplines, to help them in realising their technology’s full therapeutic potential.

coralie.palmer@mediwales.com

CUBRIC Centre Web: www.cf.ac.uk/psych/cubric

The Magstim Company Ltd Spring Gardens, Whitland Carmarthenshire SA34 0HR Tel: 01994 240798 Fax: 01994 240061 Email: info@magstim.com Web: www.magstim.com

9

BioWales 2007 Conference & Biopartnering Event

March 15th and 16th 2007 at the 5* St David’s Hotel, Cardiff World class guest speakers Andy Goldberg Medical Futures Prof Paul Smith Millennium Seed Bank, Royal Botanic Gardens, Kew Dr Jag Grewal Chairman of British In Vitro Diagnostics Association (BIVDA)

New for BioWales 2007 Panel Discussion: Finance of Bioscience

Wales Innovation Relay Centre Brokerage Event.

Chaired by Mike Ward of Biocentury, a panel of industry experts will !"#$%##&'()&*+,+$)& issues currently facing bio companies, relaying their own experience.

Now an integral part of BioWales, the brokerage event continues to grow year-on-year, with more companies, more technology -./*0)#&,+!&1/.) technology opportunities.

Andrew Heath, CEO Protherics Sam Fazeli of US investment bank, Piper Jaffray

Dr Jason Snape Science Coordinator, Brixham Environmental Laboratory, AstraZeneca

Only 2 hours from London, 30 minutes from Cardiff International Airport

www.wales.gov.uk/biowales

T

ADVERTISEMENT

H

E

M

E

D

I

W

A

L

E

S

R

Products

E

V

I

E

W

W

I

N

T

E

R

2

0

0

7

Review

Seeing the Light in Pulse Oximetry A new, portable device enables simple and precise testing of pulse oximeter accuracy by checking light wavelengths.

I N T R O D U C I N G Where The Global Biotech Industry Comes To Partner

BIO-EUROPE SPRING

Sister Conference of BIO-Europe, Europe’s Largest Partnering Meeting

MIC Centre, Milan, Italy · March 5–7, 2007 IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII Register now online at www.bioeuropespring.com IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII Major Sponsor

BIO Double Helix Sponsors

BIO Double Helix Sponsor

High Level Sponsors

Contributing Sponsors

Media Sponsors

BIO Helix Sponsor

Pulse oximeters are used in the monitoring of patients’ vital signs.

By assessing the oxygen content of the blood, they enable the state of flow of oxygen to the living tissues to be monitored continuously. Since their introduction some 20 years ago, they have become a standard part of patient monitoring equipment worldwide, and their accuracy is crucial in the management of acutely ill patients. Now the Electrode Company has developed the Lightman, the first fully portable device for testing pulse oximeter accuracy, and its findings are already making an impact.

Pulse oximeter data helps clinicians to assess the risk to patients of hypoxia (insufficient oxygen) and hyperoxia (excessive oxygen).

Electrode Company director Dr Geoff Mathews described how faulty readings can affect clinical judgement. ‘A pulse oximeter reading that is higher than true oxygen levels,’ he explained, ‘suggests oxygen is not needed when it is – risking undetected hypoxia in the patient. If on the other hand readings are falsely low, then giving supplementary oxygen might in fact induce hyperoxia.’

13

P

R

O

D

U

C

T

T

S

Products

Review

Hypoxia has long been recognised as a potential threat to patient safety. Its dysfunctional effects on the central nervous system can range from temporary confusion through to strokes and permanent brain damage. The dangers of hyperoxia in acutely ill patients are less widely known but are increasingly the focus of clinical concern. It is a recognised cause in premature babies of a potentially blinding condition, ROP (Retinopathy of Prematurity). But a BMJi paper has also highlighted the fact that hyperoxia carries serious and sometimes fatal risks for patients treated for heart attack/failure or stroke. The authors concluded that: “…pulse oximeters should be available in all clinical areas where acutely ill patients are managed and 1 oxygen is given”.

Dr Mathews and the company’s other director, paediatrician Dr Veronica Hickson, developed the Lightman specifically to check the key components affecting pulse oximeter accuracy.

The device is essentially a portable micro-spectrometer. Pulse oximetry can be thought of as a measure of blood colour: the redder the blood, the higher the oxygen saturation; the bluer the blood, the lower the saturation. A pulse oximeter measures this blood colour by the use of two specific wavelengths of light, which come from LEDs in its sensors.

E

M

E

D

I

W

A

L

E

S

R

E

Products It is the accuracy of the sensors, which is in turn dependent on these wavelengths being correct, that determines the integrity of pulse oximeter readings. The Lightman specifically diagnoses wavelength or cable errors, clearly displaying the degree to which a pulse oximeter’s readings are correct or not. It is also unique in being able to test sensors in isolation from the monitor, pinpointing faults on the spot without taking the whole system out of circulation.

Using the Lightman, The Electrode Company undertook a survey of pulse oximeter sensors in 33 hospitals across England, Wales, and Scotland between April 2004 and July 2005. Clinicians and engineers tested 847 pulse oximeter sensors from a variety of manufacturers, including all the leading brands. Of these 847, 257 (30%) were found to be ‘unacceptably’ inaccurate, i.e. with error readings of greater than plus or minus 3% (including one with an error of +17%). A further 80 (9%) proved to be ‘borderline’, with 2 errors at plus or minus 3%.

Overall then, almost one in three of the devices tested was seriously inaccurate. There are a number of factors contributing to this incidence.

To begin with, the process of installing LEDs with the correct wavelength properties in a sensor is relatively difficult to maintain in mass production. LEDs are also prone to ageing in a way that causes changes in their wavelength properties. In addition, where there is wavelength error, the sensitivity of a pulse oximeter to this error increases as the level of oxygen in the patient’s blood falls: the bluer and more hypoxic the patient, the

14

H

V

I

E

W

W

I

N

T

E

R

2

0

0

7

Review

The vulnerability of pulse oximeter sensors to error during or after manufacture, as outlined here, would suggest that sensors’ use should be attached to a standard maintenance regime to ensure accuracy. This is not in fact the case. The new International Standard on Pulse Oximeter 3 Equipment, for example, does not demand routine testing of sensor accuracy. Although therefore pulse oximeters for medical use are defined as Class IIb medical devices, regulatory compliance cannot be taken as an assurance of accuracy.

Caption

larger the sensor errors. So just when it is most needed, an oximeter can become dangerously inaccurate.

The Lightman enabled such faults to be rapidly diagnosed, its portability and ease of allowing tests to be made on site by nontechnical staff.

Prior to this technology, a pulse oximeter could only be tested by being shipped out to the specialised facilities of a suitably equipped laboratory. But the device also enabled staff to become aware of faults that had not till then been apparent – meaning faulty equipment might have stayed in use, trusted as accurate.

This ‘invisibility factor’ is reflected in the fact that the relatively high proportion of faulty pulse oximeters

in the survey came as a surprise to the clinicians and engineers involved. Clinical assessments have long incorporated the known range of external factors – from ambient light to poorly positioned probes to shivering in the patient – that can affect oximeter readings. But these external variables can effectively mask a critical factor: the internal integrity of the oximeter sensors themselves. The importance of identifying this malfunction does not only relate to older equipment.

Sensors can be faulty from new, and testing all such acquisitions prior to use can ensure that a Trust is not accepting, and paying for, faulty equipment.

The ability of the Lightman to reveal a formerly invisible malfunction impressed the survey participants, and MediWales has conducted a Health Technology KTN-supported technology audit exploring the complexities of introducing the Lightman into the highly specialised NHS marketplace. Meanwhile there has been a very positive response from clinicians who have witnessed its effectiveness, and who welcome its user-friendly design. The increasing promotion of flexibility in care delivery, favouring both portability and ease of use in medical devices, makes the Lightman particularly well designed to serve future healthcare needs.

The Electrode Company New House Llangwm Usk Monmouthshire NP15 1HJ Tel: 01291 650279 Fax: 0870 0512869 E-mail: celtic@electro.co.uk Web: www.electrode.co.uk

1 Thompson A, Webb D, Maxwell S, Grant I: Oxygen Therapy in acute Medical Care xxBMJ 2002;324:1406-7 2 Report on Pulseoximeter Sensor Survey, The Electrode Company Ltd 2005 3 ISO 9919:2005 Medical electrical equipment – Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use.

15

T

H

E

M

• Module options: fetal medicine, labour management and neonatal care • Includes support for community based care Huntleigh Healthcare’s obstetric product range includes the largest range of fetal monitors and Dopplers, the unique FetalCare software analysis and Fetal Assist tele-fetal monitor providing the vital link from community based care.

Huntleigh Healthcare’s complete product range includes many related products including obs/gynae beds & couches, cots, paediatric beds, pressure area care and DVT prophylaxis products.

Huntleigh Healthcare Limited Diagnostic Products Division

E: sales@huntleigh-diagnostics.co.uk W: www.huntleigh-healthcare.com

E

S

R

16 14 12 10 8 6 4 2 0

Of the latest round of European funding (see below for details) that went to the UK, just 1.5% was secured for Wales. And of that overall share, only 0.9% went into business and industry as opposed to academia. Additionally, the funding that Welsh organisations received between 2002 and 2006 for development within business and industry only represents 1.5% of the country’s gross value added1, compared to over 14% for the South East of England, which is the leading region for innovation and investment in R&D for new products and services.

Everybody seems to be familiar with the SMART funding available through the Welsh Assembly Government, and many organisations have also tried – some more successfully than others – to secure DTI and

uth So

Lo nd on idl an ds So uth We Yo rks st &H um be We r st M idl an ds Wa les No rth We st Sco tla nd No rth No Ea st r th ern Ire lan d

%

35 Portmanmoor Road, Cardiff. UK. CF24 5HN T: +44(0)29 2048 5885 F:+44(0)29 2049 2520

L

Percentage of funding acquired compared to GVA

Ea

• UK designed with input from UK clinicians

A

Ea st M

Innovation is a prime characteristic of some of the fastest-growing firms in Britain, and skilled specialists can help Welsh firms access substantial European innovation funding.

There is a wealth of opportunity for companies to benefit from the European Commission’s ability to finance up to 75% of the costs of developing new and innovative products and services.

The South West of England latched onto this concept long ago, but Welsh organisations have traditionally not drawn down their fair share of European funding.

• Complete solution with seamless integration throughout

W

E

V

I

E

W

W

I

N

T

E

R

2

0

0

7

Review

Shaking the EU Money Tree

st

Developed on the latest, leading-edge Microsoft.NET® platform, Eclipse MIS is easy to use, easily customised to meet local and national needs and is therefore ideally positioned to meet the requirements of national maternity healthcare programmes. It already has two installations in England and is being well received by maternity healthcare professionals throughout the UK. Covering all aspects of maternity care, including care in the community, it provides a unique platform for delivering seamless continuity of care. Its many benefits are further enhanced by the highest standards of Welsh based service and support from a company with a reputation for 1st class customer services.

I

Ea st

The Cardiff based Diagnostic Products Division of Huntleigh Healthcare are proud to announce the launch of a new world-leading Maternity Information System (MIS) to meet the requirements of today’s maternity services.

D

Products

Maternity Information System

Maternity Information System in Wales

E

technology and product prototypes. As veterans of the process, Pera can help in both these critical areas. In particular, they can help firms to combine their efforts with other like-minded companies, within an environment known in the USA as Open Innovation – as pioneered by such household names as Xerox, Hewlett Packard, Proctor & Gamble and Microsoft.

Region

European Commission (EC) funding for research and innovation.

However, EC funding opportunities are shrouded in bureaucracy and can cause confusion due to their seemingly complicated structure, or because they can leave organisations feeling that they do not have the available skills or resources to succeed.

Consultancy group Pera say that this is where their experience can help Welsh firms.

Through a network of specialists in a broad array of manufacturing and engineering sectors, Pera can provide the link between the many SMEs in Wales with expertise, an innovative mindset and a good idea, and the €50 billion available from the European Commission for research and technology development throughout Europe.

The secret for success lies in writing these funding proposals time and time again, and creating the right team of partners to deliver the new

1, Gross value is the difference between output and intermediate consumption for any given sector/industry. That is the difference between the value of goods and services produced and the cost of raw materials and other inputs which are used up in production (Office for National Statistics definition).

Pera is currently involved in supporting a project with Bridgendbased Days Healthcare, manufacturers of assistive technologies. The project, Ergosystem, is designing a patient transfer system which incorporates movement facilities to help reduce pressure sore incidence. Currently, an estimated 600 million is spent on treating back-related injuries from patient care and pressure sore treatment for those patients.

It is estimated that the project, which is coordinated by Cranfield Solutions, will bring £100 million worth of added value to the fivemember consortium by five years after the project completion.

Pera Group Pera Innovation Park Melton Mowbray Leicestershire LE13 0PB Tel: 01664 501501 Fax: 01664 501554 Email: innovation@pera.com Web: www.pera.com

17

R

E

S

E

A

R

C

T

H

Research

Review

H

E

M

E

D

I

W

A

L

E

S

R

E

Research A Fair Trial for Medical Devices A key component in evidence-based medicine, clinical trials provide the best means available of proving a causal relationship between a treatment and its effect.

The term ‘clinical trial’ itself tends to be used as a shorthand for that stalwart of medical research, the Randomised Controlled Trial (RCT).

Although now integral to modern practice, the RCT is, like antibiotics, a comparatively recent phenomenon.

It is generally agreed to have been initiated by Austin Bradford Hill’s 1948 trial, comparing streptomycin with bed rest as a treatment for tuberculosis.

In being randomised, subjects are randomly assigned to receive one of the treatments being compared. A group all receiving the same treatment makes up an arm of the trial, which will usually have two arms but possibly more.

Randomisation minimises the differences among groups by equally distributing people with particular characteristics among the trial arms.

In Hill’s trial, subjects were randomised by being assigned to treatments via cards in sealed envelopes.

The control is the standard against which evaluation is made – whether a standard treatment (which in Hill’s trial was bed rest) or a placebo. In a double-blind study, neither the investigator nor the participant is aware of which treatment is being

given; if one of them is aware, the trial becomes single-blind. If both are aware, it becomes an open trial.

These techniques all aim to eliminate as far as possible any distortion or bias, whether on the part of the researcher or the participant. The ‘placebo effect’ is the classic example of this, where a patient’s positive expectations can produce physiological improvements. There are also statistical factors to consider: in anecdotal evidence of untested treatments for example, people who have had successful results will be more likely to circulate them than people who have not.

There is therefore a standard procedure for design and implementation of clinical trials regulated in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA). Central to the information they require is the clinical trial protocol, describing its objectives, methodology and organisation. Together with full supporting documentation, this must be submitted to both the MHRA and an appropriately convened ethical committee. Both must give their approval for a trial to go ahead, and both must receive a full study report of the results once it is complete.

While most people associate clinical trials with the testing of pharmaceuticals, they are also essential for many medical devices.

The major difference is that in the majority of cases, medical device trials are undertaken solely for the product to gain a CE mark, which will allow it to be sold throughout the EU. To achieve a CE mark, it is only necessary to demonstrate the safety and performance of a device, not the degree of efficacy.

The application for a CE mark to the relevant notified body – such as BSI or TUV – demands the compilation of technical dossier. Depending on the device, supplying this evidence may demand a clinical trial, which for a non-CE marked medical device must again be approved by the MHRA. Because there is no measure of clinical efficacy required, CE mark studies are not comparative trials that aim to prove one product better than another.

Medical Device Innovations (MDi) takes on new medical and surgical device ideas and develops them to the point where they can be sold or out-licensed. As the company’s Head of Development, Dr Pete Wall is well-versed in the realities of the CE mark study process. ‘When you apply to the MHRA for approval to undertake a trial,’ he explained, ‘the authority has an obligation to respond to you within 60 days. They will inevitably have queries and will come back to you, and there’s time limit for your response. The 60-day clock will continue running down throughout that period, until they give you a report on whether or not you have a notice of approval to go ahead.’

Any clinical study involving human subjects must also be approved by an ethical committee responsible for ensuring the safety and rights of the participants.

There is a nationwide network of committees, organised from the Central Office of Research Ethics (COREC). ‘What the committees and

V

I

E

W

W

I

N

T

E

R

2

0

0

7

Review

the MHRA are looking at from their different perspectives,’ Pete continued, ‘is whether what you’re doing is safe and has value. If it has no value, or has inherent risk, or the science is flawed, then in all probability they will reject the application.’

The MHRA application requires a detailed set of documents, including two that are standard for every study.

As medical devices range from a simple wound dressing to a pacemaker, the complexity of the protocol reflects that of the device.

By the same token, in general the higher the risk of a device – say, an implantable as opposed to nonimplantable one – the greater will be the degree of documentation needed to support its safety in a trial application.

19

R

E

S

E

A

R

C

T

H

Research

Review blinded, because in many cases our end point is objective: quite simply, it’s life or death.’

On the other hand, as the professor went on to explain, if the end point of a new cancer drug trial is when a symptom emerges, people on the new drug might want to believe that it is working. If they therefore delay reporting symptoms, this could delay diagnosis. So participants’ reactions could introduce a bias – which would make blinding necessary.

‘So blinding doesn’t always apply,’ Prof Maughan continued. ‘Certainly, with many medical devices it would be difficult to blind trials effectively.

But that is not a critical factor in itself. You have to work out what the influences of its being an open trial are on your end point.’ Again, this brought us back to the factor of trial design – which is what clinical trial protocol is all about.

The growth of the Welsh medical technology sector means that alongside CE mark studies, our manufacturers are increasingly seeking the evidence of comparative trials.

Prof Maughan used the hypothetical case of a trial for a device to detect deep vein thrombosis (dvt). ‘Are you asking if it’s more effective than intravenous venography? – or if it’s more convenient to use? Those are two different questions, with different end points. So the end point is directly related to your central question, and when you design a clinical trial the key principle is that you work very hard to get that question right.’

For purely commercial purposes, such trials can demonstrate that a device is better than a competitor’s product. But they can also provide objective evidence of efficacy, which is essential when considering the ultimate objective of benefit to patients.

Here the newly established Clinical Research Collaboration Cymru can offer both skills and information.

Evolved from the concept of the Wales clinical trials network [see Review Spring 06], CRC Cymru incorporates a network for clinical trials, but its wider remit also includes non-trial research activities. While linked to the UK

20

E

M

E

D

I

W

A

L

E

S

R

Research

From application to final study report, CE mark trials can be a demanding process and few companies of any size will undertake the process in-house. Big medical device manufacturers increasingly tend to contract trials out to specialised contract research organisations (CROs), thus saving the expense of employing a core specialist team. SMEs likewise rarely have the requisite skills and experience within the company: they will usually employ consultants with specific expertise in the process, or use smaller CROs to undertake it.

As with any trial, the comparative trial of a medical device stands or falls by the quality of the trial design, which is paramount in ensuring that the evidence is robust.

H

CRC and designed to fit with it, CRC Cymru is independently funded in Wales.

Network, described how the factor of blinding is not as absolute as it might appear.

In any discussion of comparative trials for medical devices, one of the first issues to crop up is that of ‘blinding’. Given that the differences between devices are often all too visible, how can a trial be effectively blinded? CRC Cymru’s Director, Professor Tim Maughan, who is also Director of the Wales Cancer Trials

‘Blinding is only important where the end points are subjective,’ he pointed out. ‘The end point of a trial is the outcome you’re looking to measure, which will be the key indicator for success or failure. If you have strong objective endpoints then you don’t need to blind them. Our cancer trials, for example, are very rarely

So whether for devices or pharmaceuticals, the fundamentals of trial design are similar.

While at present CRC’s trials mostly concern drug therapy, its network has the capacity both to advise manufacturers and carry out device trials. A device can either be at the centre of a trial, or incorporated in a related study. A dvt detection device,

for example, might be applicable in a drug trial where dvt was a factor.

This kind of collaboration with skilled investigators could contribute to a high-quality publication of the results – which in its turn would validate usage of the new device.

Another group who can help with this process is CARE (Cardiff Anaesthetic Research and Education). As well as incorporating the Medical Device Evaluation Centre (MeDEC), which runs tests for standards compliance, CARE undertakes clinical trials focusing on new devices for anaesthesia and intensive and respiratory care. In a recent example, a CARE trial compared a new single-use laryngeal mask with the popular reusable laryngeal mask airway.

Dr Tony Wilkes, Senior Research Fellow at CARE has presented details of different study designs for comparing medical devices to the Anaesthetic Research Society.

‘Comparisons like these,’ he observed, ‘sometimes involve factors besides relative efficacy, such as ease of use or reduced cost. At CARE manufacturers can work with senior academics and healthcare professionals to make sure that such factors are built into a robust trial design.’

E

V

I

E

W

W

I

N

T

E

R

2

0

0

7

Review Medical Device Innovations (Mdi) Ltd Daresbury Innovation Centre Technology Park Halton, Cheshire WA4 4FS Tel: 01925 607030 Fax: 0870 1305387 Web: www.mdi-md.com

CRC Cymru 12 Cathedral Road, Cardiff CF11 9LJ Tel: 029 2031 6241 Web:www.crccymru.wales. nhs.uk

CARE Wales College of Medicine Cardiff University Cardiff CF14 4XN Tel: 029 2074 4852 Fax: 029 2074 7203 Web: www.carewales.co.uk

In a competitive world, rigorous evidence of the comparative benefits of a medical device is a real advantage. To achieve this, a conversation needs to take place between device manufacturers when they arrive at the stage of clinical testing,, and representatives from the relevant field. Both CRC and CARE offer a viable route to this kind of assistance, to explore how a device could be evaluated through the best possible design.

21

A

W

A

R

D

T

S

Awards

Review

On 8th November Dr Brian Gibbons, Welsh Assembly Government Minister for Health and Social Services, joined over 90 Mediwales members as a guest at our first MediWales Annual Innovation Awards Dinner.

Held at Cardiff’s Hilton hotel, the awards celebrated the hard work and achievement of the five award winners and of the many other Welsh companies who have succeeded in this challenging sector, where innovation is key in reducing treatment costs and improving patient care.

The judges were selected from directors of MediWales and selected experts from International Business Wales and the Welsh NHS. Each sponsor has donated a package of services as a prize, intended to promote close collaboration between companies and service providers. The prize-winners will now be put forward to the National Medilink UK Awards along with category winners from each of the regions.

E

M

E

D

I

W

A

L

E

S

Awards

innovation

The award for outstanding innovation, sponsored by PDR, went to Mr John Maisey and Dr James Brewer of Cardiff and Vale NHS Trust, for the invention of a device for tying knots during minimally invasive (keyhole) surgery which will reduce the time taken to carry out procedures requiring stitches, with all the relative benefits to the patient and cost savings.

H

A

R

E

V

I

E

W

W

I

N

T

E

R

2

The prize for successful collaboration with the NHS, sponsored by Geldards, went to The Magstim Company Ltd of Carmarthenshire. The award was for Magstim’s work with Whitchurch Hospital in Cardiff and the University of Edinburgh Hospital to develop the ‘Magstim Theta’, an alternative treatment for drug-resistant depressive disorder, which led to the process being trialled for the first time anywhere in the world in June of this year.

“

0

7

Review

ARDS The award for exceptional growth, sponsored by LifeForce, was awarded to Protherics Plc. In 2005 Protherics announced the signing of the UK’s largest biotech product licensing deal with Astra Zeneca, for Protherics’s innovative product cytoFabTM, manufactured in Llandysul, Wales. cytoFabTM, is being trialled for the treatment of severe sepsis, a potential market of US$8 billion.

0

The prize for the best business start-up, sponsored by UDL, went to Medaphor Ltd. Medaphor has a novel and innovative solution to a problem within medical and ultrasound training. Integrating advanced 3D animation, teaching materials and ultrasound scans provide interactive online skills training for medical students.

The prize for export achievement, sponsored by Abel and Imray, went to Performance Health Products Ltd of Pyle, manufacturers of rehabilitation products for wheelchair users. Their efforts in international trade since 1999 have resulted in sales of their product range in over 18 countries, including establishment of a wholly-owned subsidiary in Atlanta Georgia.

Innovations can include new or improved ways of delivering services or treatments...

In Wales the NHS works closely with universities and business to ensure we share ideas, drive up standards and improve patient care.

”

Dr Brian Gibbons, Welsh Assembly Government Minister for Health & Social Services

ADVERTISEMENT

stem cell suite and flow cytometry unit A new CITER funded stem cell suite and flow cytometry unit has recently opened within the School of Biosciences at Cardiff University. The facility is primarily set up for stem cell work but flow cytometry can be performed on all cell types. The facility comprises a BD FACS Canto and FACS Aria.

The dual laser Canto is able to analyse up to 6 colours and is also equipped with a 40-tube carousel. The triple laser, high speed Aria can detect 15 independent signals at a rate of 70,000 events per second. Two and four-way sorting are standard features, however the Aria can also sort single cells into a variety of tissue culture plates.

The unit also has tissue culture facilities for both primary culture and established cell lines, the latter being a mycoplasma free environment. The suite also houses a time-lapse fluorescent microscope and ultra low temperature tissue/cell storage facility.

Further details: www.cardiff.ac.uk/biosi/research/stemcell/index.html

6W 'DYLGV $VVHPEOLHV /LPLWHG 3UHVVLQJV 0RXOGLQJV $VVHPEOLHV /LPLWHG

&OHDQ 5RRP ,QMHFWLRQ 0RXOGLQJ DQG $VVHPEO\ 6W 'DYLGV $VVHPEOLHV /LPLWHG LV RQH RI WKH 8.¶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¶V OHDGLQJ VXSSOLHUV RI SUHFLVLRQ FRPSRQHQWV WR WKH $XWRPRWLYH 'RPHVWLF DSSOLDQFH DQG 0HGLFDO ,QGXVWULHV DQG DUH D ZRUOG FODVV RUJDQLVDWLRQ TXDOLILHG WR ,62 4XDOLW\ 6WDQGDUGV 7KH FRPSDQ\¶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

3URGXFWLRQ IDFLOLWLHV ‡ &OHDQURRP ,QMHFWLRQ PRXOGLQJ ‡ &OHDQURRP $VVHPEO\ ‡ +LJK TXDOLW\ SUHVV ZRUN ‡ +LJK VSHHG FRQWDFW ZHOGLQJ ‡ 3ODVWLF LQMHFWLRQ PRXOGLQJ VSHFLDOLVLQJ LQ JODVV UH HQIRUFHG HQJLQHHULQJ SODVWLFV ‡ ,QVHUW DQG 2XWVHUW PRXOGLQJ WHFKQLTXHV ‡ 7ZLQVKRW PRXOGLQJ ‡ +DQG DQG DXWRPDWHG DVVHPEO\ ‡ 3UHFLVLRQ LQVSHFWLRQ DQG PHDVXUHPHQW ‡ 3URGXFW WHVWLQJ ‡ 4XDOLW\ V\VWHPV SURYHQ LQ KLJK YROXPH SURGXFWLRQ ‡ 'HVLJQ 3URWRW\SLQJ

0HGLSH[ 1+6 ,QQRYDWLRQ +XE IRU <RUNVKLUH DQG +XPEHU

0HGLSH[ LV WKH 1+6 ,QQRYDWLRQ +XE IRU <RUNVKLUH +XPEHU DQG ZH DUH UHVSRQVLEOH IRU PDQDJLQJ DQG FRPPHUFLDOO\ H[SORLWLQJ LQWHOOHFWXDO SURSHUW\ ,3 DULVLQJ RXW RI 1+6 DFWLYLWLHV

7(&+12/2*< 23325781,7,(6 :H KDYH WKH IROORZLQJ RSSRUWXQLWLHV ZKHUH ZH DUH VHHNLQJ FRPPHUFLDO SDUWQHUV VRPH RI WKHVH RSSRUWXQLWLHV DUH DYDLODEOH IRU GLUHFW VDOH DQG RWKHUV UHTXLUH FROODERUDWLRQ WR GHYHORS D PDUNHW UHDG\ SURGXFW â&#x20AC;¢

'\QDPLF 6WDWLF )RRW 3UHVVXUH 6\VWHP UHI )RRW SHGRJUDSK\ V\VWHP IRU ERWK G\QDPLF DQG VWDWLF IRRW SUHVVXUH PHDVXUHPHQWV WR LQIRUP SRGLDWULVW RUWKRSDHGLF VXUJHRQV DQG GLDEHWLFLDQV RQ IRRW SUHVVXUHV DQG RQ SRWHQWLDO RXWFRPHV RI VXUJHU\

â&#x20AC;¢

3DWLHQW 5HWDLQLQJ 6WUDSV UHI 6HOI UHFRLOLQJ UHWDLQLQJ VWUDSV

â&#x20AC;¢ 3DHGLDWULF 9LVXDO )LHOG $QDO\VHU UHI $ FOLQLFDOO\ UHOHYDQW PHWKRG RI WHVWLQJ SHULSKHUDO YLVLRQ LQ EDELHV DQG VPDOO FKLOGUHQ â&#x20AC;¢ 6DFUDO 6XSSRUW $UP UHI 2SHUDWLQJ WDEOH DFFHVVRU\ WR HQVXUH FRUUHFW SRVLWLRQLQJ RI SODVWHU FDVW â&#x20AC;¢ 8OWUDVRXQG +DUPRQLF UHI 8OWUDVRXQG GHYLFH IRU DFFXUDWHO\ PHDVXULQJ EORRG IORZ ZLWKRXW FRQWUDVW DJHQWV â&#x20AC;¢

8URORJLFDO 'LJLWDO GLDU\ UHI 'LJLWDO GLDU\ IRU XURORJLFDO SUREOHPV

â&#x20AC;¢ %ODGGHU 3UHGLFWLRQ %LRWHFK GDWD KDQGOLQJ UHI $ FOLQLFDO GHFLVLRQ VXSSRUW WRRO EDVHG RQ QHXUR IX]]\ PRGHOOLQJ WR SUHGLFW SURJUHVVLRQ RI EODGGHU FDQFHU DQG LWV PDQDJHPHQW â&#x20AC;¢ /LYHU .LGQH\ ,QIRUPDWLRQ 0DQDJHPHQW 6\VWHP UHI $ VRIWZDUH V\VWHP ZKLFK FDQ EH FXVWRPLVHG IRU WKH VWRUDJH RI FOLQLFDO LQIRUPDWLRQ LQ DQ\ KRVSLWDO XQLW â&#x20AC;¢ 6($7 UHI 6RIWZDUH WRRO XVHG E\ WKHUDSLVWV WR DVVHVV PRWRU VNLOOV DQG ,7 FDSDELOLWLHV RI XVHUV RI ($7 HTXLSPHQW â&#x20AC;¢

5DGLRJUDSKLF &DOOLSHUV UHI $OORZV WKH DFFXUDWH VL]LQJ RI SURVWKHWLFV IURP ; UD\ LPDJHV

â&#x20AC;¢

&DQFHU GLDJQRVWLF UHI &DQFHU GLDJQRVWLF WHFKQLTXH WR DLG GHWHFWLRQ RI FRORUHFWDO FDQFHU

â&#x20AC;¢

'1$ 51$ ([WUDFWLRQ %XIIHU UHI $ QRYHO EXIIHU DQG DVVRFLDWHG PHWKRGRORJ\ ZKLFK HQKDQFHV WKH TXDOLW\ RI '1$ DQG 51$ H[WUDFWHG IURP SDUDIILQ HPEHGGHG WLVVXHV

â&#x20AC;¢

)RFXVVHG ,PSULQWHG *HQH $UUD\ UHI 'HYHORSPHQW RI D IRFXVVHG JHQH H[SUHVVLRQ PLFUR DUUD\

â&#x20AC;¢

*DVWULF $FLG 6HFUHWLRQ UHI $ QRQ LQYDVLYH WHFKQLTXH IRU WKH PHDVXUHPHQW RI JDVWULF DFLG VHFUHWLRQ

6KRXOG \RX KDYH DQ\ HQTXLULHV RU UHTXLUH IXUWKHU LQIRUPDWLRQ SOHDVH GR QRW KHVLWDWH WR FRQWDFW XV 6W 'DYLGV $VVHPEOLHV /LPLWHG *ODVIU\Q 5RDG 6W 'DYLGV +DYHUIRUGZHVW 3HPEURNHVKLUH 6$ 5< 7HO )D[ (PDLO VDOHV#VWGDYLGVDVVHPEOLHV FR XN :HE ZZZ VWGDYLGVDVVHPEOLHV FR XN

,I \RX ZRXOG OLNH WR ILQG RXW PRUH LQIRUPDWLRQ DERXW WKHVH YLVLW RXU ZHEVLWH ZZZ PHGLSH[ FR XN RU SOHDVH FRQWDFW 6WHSKDQLH %ULGJIRUG $GPLQLVWUDWRU RU H PDLO 6WHSKDQLH EULGJIRUG#PHGLSH[ FR XN

Notes

Letters

Review

From Prof Sir Roger Feneley me is that of supplying drinks to A problem that has been concerning r on they are out of reach of the jug of wate elderly/disabled patients. Very often ual man of loss of use beca bler the tum their bedside table, or they cannot fill . dexterity filled enser were designed which could be This problem could be resolved if a disp a with d fitte be t migh uct . The prod once a day by the nurse/care assistant ece which could be clipped on to thpi mou and tube ble flexi , user-friendly nightshirt or chair. It would then be a as something within easy reach, such were able to drink as they needed simple to ensure that these patients save nursing time. throughout the day, and would also ly a product in residential homes for elder I think there might be a place for such tiple mul or ics led people such as tetrapleg people, or convalescent wards for disab sclerosis patients.

Roger Feneley BioMed Health Technology Co-operative Bristol Urological Institute Bristol

Wales Innovation Relay Centre The Wales Innovation Relay Centre (WIRC) works with Welsh companies, universities and research centres to facilitate technology transfer and to exploit new research and innovation.

It is part of the international Innovation Relay Centre network established by the European Union to support innovation and transnational technology transfer.

This network currently spans 33 countries, including all EU member states as well as Bulgaria, Chile, Iceland, Israel, Norway, Romania, Switzerland and Turkey.

The WIRC helps companies to explore ways in which their products and processes can be improved by adopting new and emerging technologies. It alerts businesses to the latest technology developments from across Europe and can help them through the technology transfer process.

As part of the innovation relay network, the WIRC is ideally positioned to broker transnational deals and to help companies successfully apply for EU R&D funding. It can assist companies in Wales to commercialise and exploit their innovative technologies by helping them find suitable partners throughout Europe for further development, licensing agreements, joint ventures, manufacturing partnerships and other collaborative arrangements.

WIRC staff also help organise and participate in numerous international brokerage events and thematic groups which provide opportunities for Welsh businesses and research organisations to meet potential technology partners, licensees and suppliers.

The WIRC is funded by the Welsh Assembly Government and the European Union’s Innovation Programme, and its services are free and available throughout Wales. The centre is staffed by a team of case officers, who all have expertise in technology transfer and wide-ranging industrial and R&D experience.

The team are adept at helping smaller companies that may lack the information, resources and specialised skills to find suitable technology partners and negotiate technology transfer agreements.

Our event on 4th October, ‘The NHS Marketplace’, proved to be highly successful. Over 60 delegates received presentations from representatives of the Welsh Assembly Government on local supply initiatives, Welsh Health Supplies on supplying the Welsh NHS, the MHRA in relation to medical devices, and Swansea NHS Trust on a Trust’s experience of sourcing medical equipment.

Presentations were followed by a lively group discussion on the reality of overcoming the barriers to selling in the NHS marketplace from the perspective of Welsh medical technology SMEs and large companies. This event brought to the fore a number of issues which will be explored in our Spring edition of the Review.

For more information visit www.walesrelay.co.uk

●

WRC Advert 210 x 148.5mm.indd 1

17/5/06 12:09:35 pm

NEWS

●

EVENTS

●

NEWS

●

MediWales is currently looking into the potential for a Special Interest Group focusing on the area of wound healing and prevention.

This could incorporate the numerous sectors in Wales whose products impact on this particular area of expertise, along with globally recognised research centres & universities.

We are also working to set up a core seminar early next year on the subject of technology transfer This will include both university and company presentations on the knowledge transfer partnership programme, as well as a review of funding opportunities and an overview of centres of excellence in Wales. With the launch of new DTIfunded initiatives and the Welsh Assembly Government-funded

EVENTS

●

NEWS

●

EVENTS

●

NEWS

WIsH, this event will be an opportunity to explore their performance so far.

MediWales has also been successfully liaising with International Business Wales to send a fact-finding mission to the Arab Health international trade show in January 2007. Provided this mission proves fruitful for the delegates supported to attend, we look forward to a larger government-sponsored presence at this increasingly important global medical technology event. .

●

EVENTS

●

NEWS

●

EVENTS

●

NEWS

Medical & BioScience Animation Brochure & Print Design Exhibition Graphics Video & DVD Loops Presentations Web & Interactive

“Eclipse create engaging design and animation in the field of Medical Science” Our work both informs and educates a wide range of

Over ten years experience and fully resourced studio

audiences – high resolution 3D graphics can be utilised

facilities allow us to provide clients with excellence in

standalone or incorporated with other 2D materials for a

service, design and production.

variety of applications – video, presentations, print, interactive and exhibition panels.

Eclipse (Creative) Limited

Pascoe House, 54 Bute Street, Cardiff CF10 5AF T +44 (0) 29 2047 0070 F +44 (0) 29 2047 0071 info@eclipsecreative.co.uk www.eclipsecreative.co.uk