UK Lifescience Industry Edition 5

7UK Lifescience Industry Magazine

Advances in health technology

Issue 5

INDUSTRY

United Kingdom

Going global: Cracking global markets

Enhancement: Making medicines better

Future watch: Potential healthcare game changers

Made in the UK: Keeping manufacturing at home

Meeting the unmet: Responding to unmet clinical needs

Working Together

Inside:

Academic Health Science Networks:What will they mean for industry?

UK Lifescience Magazine

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“The Development of Academic Health Science Networks (AHSNs)Medilink UK and the Association of British Healthcare

Industries (ABHI) concordat has provided a unique

opportunity to create cohesive guidance on working

with industry and generating wealth at a national,

regional and local level.

The concordat has provided leadership at a national

policy level through ABHI and operational substance

at a regional and local level through the Medilink UK

organisations.

Medilink UK is impressed by just how quickly the

life science industry has reacted to this opportunity

for a new way of working with the NHS through the

emerging AHSN networks.

We look forward to continue working with the

life science businesses to inform the industry

engagement aspect of the AHSNs and urge all to

participate as much as possible for maximum gain.

Tony Davis Chairman, Medilink UK

A message from the chairman of Medilink UK

2012 ISSUE 4

7 Schooner Way, Atlantic Wharf, Cardiff CF10 4DZTel: 029 2047 3456 Web: www.mediwales.com The views expressed in this publication do not necessarily represent the opinions of individual Medilink UK members unless explicitly stated. © MediWales Ltd. 2012

Produced by MediWales for Medilink UKDesigned by Teamworks Design & Marketing

Contact:

Editor: Jess [email protected]

Advertising: Charlotte [email protected]

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Issue 5

Jess Fisher Editor

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2012 ISSUE 4



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www.medilinkuk.com

PUBLISHED BY


Issue 5

Jess Fisher Editor

2012 ISSUE 4



Contact:





















L

www.medilinkuk.com

PUBLISHED BY


Issue 5

Jess Fisher Editor

INDUSTRY

United Kingdom

INDUSTRY

United Kingdom

This edition

4-8

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Lorem ipsum dolor sit amet, consectetur adipisicing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation

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Lorem ipsum dolor sit amet, consectetur adipisicing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehen-derit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est

Monica Healthcare’s abdominal fetal ECG and uterine EMG monitor has cracked the global marketplace.

Working Together Academic Health Science Networks: What will they

mean for industry?

9 UK Lifescience Industry Event Calendar

“A message from the editor

Going Global13 UK goes nuts for Brazil13 Monica’s monitor14 Britain thrives in assisted

living14 Breathe easy15 Bionic finger points to

better future

Enhancement18 Coughing up the goods18 From days to weeks

Future Watch20 Digital diary aids care21 Diabetes drug delivery

discovery

Culture shiftsThe imminent Academic Health Science Networks (AHSNs) could be seen as just another network set up to ease the identification, uptake, and spread of innovation within the NHS.

The distinct difference with AHSNs is that they are being instigated from the top down: for the first time CEOs within not only industry but the NHS and academia are leading the change.

This approach represents a cultural shift within the NHS in England, recognising industry as natural partners to better the health and wealth of the UK.

The lead article briefly summarises AHSNs and focuses on the development of two of the regional networks, seeking insight from the leading industry partners - the Medilinks.

Other British advancements in healthcare are explored through the themes of:

Going global Cracking the global marketplace

Enhancement Making medicines better

Future watch Potential healthcare game changers

Made in the UK Keeping manufacturing at home

Meeting the Responding to unmet

unmet clinical needs

Jess Fisher Editor

Made in the UK24 From technical textiles to medical

marvels24 Hands-on improvement27 Lean machines boost sales

Meeting the unmet28 Real-time diagnosis for

cervical cancer30 DNA to identify early signs

of breast cancer31 Centre calls for patient-specific

medical projects32 Well connected for

wellbeing33 It’s all in the hips34 Stopping skin tear

suffering34 Raising the

standard35 World’s first

artificial liver to replace animal testing

13


2012 ISSUE 4



Contact:





















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PUBLISHED BY


Issue 5

Jess Fisher Editor

7 Schooner Way, Atlantic Wharf, Cardiff CF10 4DZTel: 029 2047 3456 Web: www.mediwales.com

The views expressed in this publication do not necessarily represent the opinions of individual Medilink UK members unless explicitly stated. © MediWales Ltd. 2012



Academic Health Science Networks will bring together the NHS, academia, industry and other major stakeholders to improve the identification, uptake and spread of innovation in the NHS in England.

The networks represent a cultural shift in the NHS, recognising that service delivery can only be transformed through the rapid adoption of new technologies and that this requires the strategic participation of the UK life sciences business community.

The life science business community welcomes this collaborative approach – a marked departure from the NHS’s stereotypical position of being a risk averse and slow adopter of innovation, more concerned with short term cost savings than investing to save.

ACADEMIC HEALTH SCIENCE NETWORKS – WHAT WILL THEY MEAN TO INDUSTRY?

Jess Fisher summarises the purpose of the impending AHSNs and discusses more specific plans for the East Midlands and Yorkshire networks.

Working together

Where have they come from? AHSNs have been initiated by the Department of Health – one of the key action points in its Innovation, Health and Wealth report to “ramp up the pace and scale of change” in the health service and drive growth in the wider economy.

The main thrust of AHSNs will be developing links across disciplines and establishments and engaging with industry in a way that has not taken place previously. There are six key functions of AHSNs set out in the guidance from the Department of Health, which are:

Research participationTranslating research and learning into practiceEducation and trainingService improvementInformationWealth creation

Industry’s involvement has a place in all 6 of these functions. Currently, 14 of the 15 initial AHSN proposals submitted in the summer have been approved for full business case development and some initial drafts have been made publically available for consultation. The deadline for full proposals is 24 January 2013, with the intention for the AHSN’s to go live from 1 April 2013.

The cultural shift may be slow, but as the spread of innovation, health and wealth develops in England, what does industry stand to gain?

Working Together

Governance and financeHow the AHSNs will be funded and governed is yet to be finalised, however once designated, each AHSN will have a five-year license and work on a cost-per-patient model. Essentially the larger the geographic scope for the AHSN, the greater the population, and subsequently the funding received.

Each AHSN will assign a corporate board to guide its structure and development.

At the NHS Confederation conference in September 2012, Sir Ian Carruthers said the AHSNs could receive tens of millions of pounds worth of funding from the NHS Commissioning Board.

Many AHSNs may also develop their own commercial structures to enable a sustainable long-term model.

A network of networksThe intention is that all NHS organisations should look to be affiliated to their local AHSN. In many cases, such as the East Midlands, the creation of the AHSN is being led by a hospital trust – this in itself sets a precedent for NHS engagement.

Through a closer networking relationship between the NHS

and industry, the AHSN can then provide an easier route to assess, commercialise and adopt health technologies into the NHS at a much faster rate.

The challenge is to successfully develop and exploit innovation at a greater speed and scale than has been seen previously, whilst also managing the issues over collaboration, governance, finance and competition.


AHSNsworking together

on innovation

NHSservice

providersHigher

Education

Industry and

pharma

Local government

Communityservices

Charities

Otherparties...

NHSCommissioners

East Midlands AHSNFor many AHSNs, regional Medilinks are taking an active role in business plan development. As advocates for the life science industry regionally, they can also leverage their collective national network – Medilink UK, the largest representative body for this industry sector.

and procedures by those that lead in a field to avoid unnecessary duplication and spread the best innovations and services across the NHS UK-wide.”

“In East Midlands one of the areas of focus will be on diabetes – it may be that East Midlands AHSN will take a lead on that area across the AHSNs and share research, ideas and advancements with the others, for instance.”

Nottingham University Hospitals Trust took the lead on the project and set up an executive group to put the proposal together. Medilink East Midlands was asked to develop the industry-NHS engagement areas and are holding a series of workshops to gather industry input.

Yorkshire AHSNSimilarly in Yorkshire, Medilink has been asked to contribute to the industry-NHS engagement planning for the AHSN.

UK Lifescience Industry Magazine

A regional perspective

“Darren Clark, Medilink East Midlands’ Chief Executive discusses their involvement in the East Midlands AHSN:

“The AHSNs appear to be the main way to achieve the DH’s innovation, health and wealth plans. This is a real step-change for the NHS to focus on the wealth as well as the health agenda, however the networks’ name is a slight misnomer – they should probably be called Industry Health Science Networks to reflect the level of industry engagement.”

In the East Midlands the AHSN partners have decided to create a regional as opposed to a city-based approach due to the existing excellent networking and collaboration between several cities and towns in the area such as Nottingham, Derby, Lincoln, Northampton, and Leicester.

“Each AHSN will have its own areas of strength – the idea is that best practice will be shared on successful projects, technologies

“Medilink Yorkshire and Humber’s Managing Director Kevin Kiely discusses his views on the Yorkshire AHSN:

“One of the biggest issues facing the UK life science industry continues to be the slow and fragmented adoption of new innovations, leading to poor returns on innovation investment and an increasingly risk averse investment community for life science projects.

“It has been recognised for over a decade and referenced in a number of reports that the NHS, as the largest health delivery agency in the world, could, if managed correctly, become a significant driver for economic growth.

“The AHSNs commit NHS organisations at a strategic level to the identification, uptake, and spread of new innovations into the NHS, whereas previous adoption initiatives were tangential to the people that would make this happen.”

““As partners on the development of the East Midlands AHSN, Medilink will provide good access for industry members to the NHS – something that companies continually struggle to attain,” said Darren.

“For this to work effectively, Medilink would like to see standardised processes, agreed messages and objectives between all partners, and economic impact measures put in place as targets.”

7

Working Together

The AHSNs will become a key component of the new innovation landscape dovetailing with the new clinical commissioning groups (CCGs), both to take effect on 1 April 2013.

For instance, the CCGs are likely to take responsibility for the Small Business Research Initiatives (SBRI), with the operational component being cascaded down to, and informed by AHSNs, which would be in the best position to identify and prioritise areas of unmet needs.


When asked what success will look like, Kevin commented:

The AHSNs will also work closely with NIHR’s new Health Technology Cooperatives (HTCs) to be launched in January 2013 – the HTCs being based around major areas of unmet clinical needs, providing a vital NHS/ patient pull for new technological inspired solutions.

The question was posed to Kevin, ‘why will AHSNs work, when so many initiatives have been started up and haven’t achieved tangible impact?’

Feedback from Medilink UK and ABHI points out the pitfalls to be avoided, and success measures to be implemented, when developing the AHSNs:

““

“For the AHSNs to succeed there needs to be a two-way cultural shift where both industry and the NHS have mutual respect for each other’s skills and resources and where businesses are seen as natural partners in translating research and new technology into workable commercial solutions for improving healthcare delivery.”

“The successful output from these new networks will be a measurable improvement in healthcare delivery against priority targets set by each AHSN. For instance reduction in obesity levels, or reduced social inequality evidenced by morbidity rates, and a resultant increase in wealth, measured by increased jobs, new intellectual property or new spin out companies.”

l At a national level, an immense amount has been learned about evaluation, so reinventing the wheel locally must be avoided and instead a ‘do once and learn’ attitude adopted

l Avoid bringing industry in only at the commercialisation stage of projects. The NHS needs incentives to ensure interaction. For instance, funding could be linked to consistent measurement of AHSN collaboration results

l Need to work with industry on providing evidence on efficacy, efficiency and cost effectiveness of innovative technologies and services, which in turn will promote wide scale NHS recognition of this evidence and ultimately stimulate adoption

l Need to measure the economic impact – the regional picture in the context of the big, national picture

l Metrics on companies supported, manufacturing capacity and supply chain details must be recorded to show impact

l Need industry inclusion in design, governance and delivery of projects targeted at industry; ensuring they are fit for purpose and in a language industry understands and can respond to

“Each AHSN will be charged with the responsibility to rapidly adopt new technological solutions to improve patient care and prevent the incidence of disease. This has the top down strategic commitment from NHS CEOs – it is not a peripheral activity but one which NHS Trusts will be held to account. The strategic link between health and wealth is particularly encouraging in respect to private sector engagement.”


Calendar

UK Lifescience Magazine

December5th: Medilink North West: Ask the Expert, Stockport

6th: Medilink East Midlands: Asia Pacific Lifescience Clinics, Nottingham

6th: Medilink West Midlands: Christmas Networking, Birmingham

11th: HealthTech and Medicines KTN: Imaging as an enabling technology to advance stratified medicine, London

11th UK HealthTech Conference, Cardiff, UK

11th MediWales Annual Innovation Awards Dinner, Cardiff, UK

13th Genesis, London

January16th-17th HealthTech and Medicines KTN: Biomarkers Summit –

Innovations in Stratified Medicine, London

18th-19th: IBHI Indo-UK Diabetes Summit, India

22nd: HealthTech & Medicines KTN: UK Strength & Opportunities in the Assistive Living Market Regional profiles for East Midland, West Midlands & Wales; Birmingham

24th: Digital Marketing to Grow your Medical Business, Medical Technologies Innovation Centre, Birmingham

24th: Medilink East Midlands: Stratified Medicine, Leicester

28th-31st: Arab Health, Dubai (Welsh Government Mission)

30th: Medilink West Midlands: Selling Assistive Technologies to the Private Sector, Chester

February 6th – 7th: Informa Life Sciences “The Medical Device

Directives and The Revision”, Belgium

7th: Medilink East Midlands: Exploiting Intellectual Property in Healthcare

7th: Life Sciences Scotland: Scottish Enterprise Life Sciences Annual Dinner and Awards 2013, Edinburgh

13th: Medilink East Midlands: East Midlands Infectious Disease Research Network

27th-1st: RehabTech Asia, Singapore

28th: NHS Productivity: Transforming Healthcare, Harrogate

March5th-6th: HealthTech and Medicines KTN: Assisted Living

Innovation Platform Showcase, Liverpool

11th-13th: Innovate UK, London

13th-14th: NHS Innovation Expo

19th-20th BioWales 2013, Cardiff, Wales

17th-21st Pittcon, Philadelphia, USA.

30th-1st April Nanotech, Tokyo, Japan

April4th-7th: Expomed Istanbul, Turkey

10th-11th: MedTech Innovation Expo 2013, Coventry

16th-17th: In4matics Healthcare and Informatics Expo, Birmingham

22nd-25th: BIO International Convention, Chicago, USA

May1st-2nd: Medtec UK, London

3rd: Wellcome Trust Health Innovation Challenge Fund (round 8), funding deadline

13th-15th: eHealth Week, Dublin, Ireland

13th-16th: ACHEMASIA 2013, Beijing, Asia

14th-15th: NICE Annual Conference 2013, Birmingham

21st-24th: Hospitalar 2013, Sao Paulo, Brazil

29th-30th BioDundee International Conference

UK Lifescience Industry Event Calendar2012-2013

9

Event Calendar

6UK Lifescience Magazine

We have made it easier to discover,

develop and deliver healthcare innovation in the UK

Opening access to data, leveraging the power

of the National Health Service

The UK’s Commitment to Life SciencesThe emergence of new models of care, disruptive technologies, information and health management systems, and new medical practices puts the Healthcare and Life Science industry at the epicentre of global change – economic, political, technological and commercial. In developing the UK Life Science Sector, the UK Government has introduced new initiatives that span the sector and aim to make the UK the best possible environment to conduct research, develop new products, and launch them into a responsive healthcare market.

The UK has five critical capabilities that support the translation of ideas from the bench to products and services at the bedside

2. Commitment to partnership between academia, clinicians, the National Health Service, and industry

For more information, please contact [email protected]

1. A vibrant basic research environment

3. An environment where both the public and private sector share risk to invest in innovation The UK is committed to making every patient a research patient. The National

Health Service (NHS) is a powerful partner helping health and outcomes research, to better understand the patient journey.

INNOVATIONIS

HOW UK TRADE & INVESTMENT CAN HELP:UK Trade & Investment (UKTI) is the government department that helps UK companies export and expand into new markets, and

supports overseas businesses to invest successfully into the UK. UKTI combines the expertise of professional trade and industry

advisers in the UK alongside a global network of experts based in British diplomatic offices overseas, giving you access to a

well-connected presence on the ground at home and in the UK. Our practical help and advice is free and confidential.

CLINICAL PRACTICE RESEARCH DATALINK (CRPD): The Clinical Practice Research Datalink is a new, secure service linking primary and secondary care data for more than 53 million patients. CPRD supports research, clinical trials feasibility and protocol optimisation, and provides information on patient outcomes.

ACCESSING NATIONAL DATA SETS: In addition to CPRD, access is also available to Scottish and Welsh eHealth record systems, allowing you to access a breadth of patient data and real-world insight.

HEALTH EPISODE STATISTICS (HES): HES is the national statistical data warehouse recording care provided by England’s NHS hospitals and for NHS hospital patients treated elsewhere. It contains admitted patient care data from 1989 onwards, with more than 12 million new records added each year.

NHS INFORMATION CENTRE: England's central, authoritative source of health and social care information for frontline decision makers.

4. A complete ecosystem where you can work with all stakeholders, including: academia, emerging SMEs, companies providing contract research, manufacturing and IT infrastructure, and social media platforms

5. An open and reactive healthcare system and regulatory framework

www.ukti.gov.uk

RING-FENCED BASIC RESEARCH BUDGET - The UK has protected the UK’s science budget and is committed to supporting core science funding. The UK is also making major investments in genomics, informatics, and synthetic biology.

INVESTMENT IN HEALTH RESEARCH – The UK is expanding the number of biomedical research centres and units in the UK, with an additional investment of £800 million over the next five years.

PATENT BOX - From April 2013, corporation tax on profits from patents will be reduced to 10%, and will apply to net income on patents first commercialised after 29 November 2010.

THE UK BIOBANK - The UK Biobank is a major national health research resource, linking detailed information and samples from 500,000 people.

INTELLECTUAL PROPERTY PROTECTION - The UK has now implemented new cost-effective ways of protecting intellectual property through the County Courts.

INFRASTRUCTURE SUPPORT - The UK spends circa £1 billion annually on the National Institute for Health Research (NIHR) infrastructure, supporting experimental medicine research and clinical trials.

NIHR OFFICE FOR CLINICAL RESEARCH INFRASTRUCTURE (NOCRI) – NOCRI facilitates industry access to the UK’s clinical research infrastructure, from early-stage collaborative research through to contract clinical trials.


We have made it easier to discover,

develop and deliver healthcare innovation in the UK

Opening access to data, leveraging the power

of the National Health Service

The UK’s Commitment to Life SciencesThe emergence of new models of care, disruptive technologies, information and health management systems, and new medical practices puts the Healthcare and Life Science industry at the epicentre of global change – economic, political, technological and commercial. In developing the UK Life Science Sector, the UK Government has introduced new initiatives that span the sector and aim to make the UK the best possible environment to conduct research, develop new products, and launch them into a responsive healthcare market.

The UK has five critical capabilities that support the translation of ideas from the bench to products and services at the bedside

2. Commitment to partnership between academia, clinicians, the National Health Service, and industry

For more information, please contact [email protected]

1. A vibrant basic research environment

3. An environment where both the public and private sector share risk to invest in innovation The UK is committed to making every patient a research patient. The National

Health Service (NHS) is a powerful partner helping health and outcomes research, to better understand the patient journey.

INNOVATIONIS

HOW UK TRADE & INVESTMENT CAN HELP:UK Trade & Investment (UKTI) is the government department that helps UK companies export and expand into new markets, and

supports overseas businesses to invest successfully into the UK. UKTI combines the expertise of professional trade and industry

advisers in the UK alongside a global network of experts based in British diplomatic offices overseas, giving you access to a

well-connected presence on the ground at home and in the UK. Our practical help and advice is free and confidential.

CLINICAL PRACTICE RESEARCH DATALINK (CRPD): The Clinical Practice Research Datalink is a new, secure service linking primary and secondary care data for more than 53 million patients. CPRD supports research, clinical trials feasibility and protocol optimisation, and provides information on patient outcomes.

ACCESSING NATIONAL DATA SETS: In addition to CPRD, access is also available to Scottish and Welsh eHealth record systems, allowing you to access a breadth of patient data and real-world insight.

HEALTH EPISODE STATISTICS (HES): HES is the national statistical data warehouse recording care provided by England’s NHS hospitals and for NHS hospital patients treated elsewhere. It contains admitted patient care data from 1989 onwards, with more than 12 million new records added each year.

NHS INFORMATION CENTRE: England's central, authoritative source of health and social care information for frontline decision makers.

4. A complete ecosystem where you can work with all stakeholders, including: academia, emerging SMEs, companies providing contract research, manufacturing and IT infrastructure, and social media platforms

5. An open and reactive healthcare system and regulatory framework

www.ukti.gov.uk

RING-FENCED BASIC RESEARCH BUDGET - The UK has protected the UK’s science budget and is committed to supporting core science funding. The UK is also making major investments in genomics, informatics, and synthetic biology.

INVESTMENT IN HEALTH RESEARCH – The UK is expanding the number of biomedical research centres and units in the UK, with an additional investment of £800 million over the next five years.

PATENT BOX - From April 2013, corporation tax on profits from patents will be reduced to 10%, and will apply to net income on patents first commercialised after 29 November 2010.

THE UK BIOBANK - The UK Biobank is a major national health research resource, linking detailed information and samples from 500,000 people.

INTELLECTUAL PROPERTY PROTECTION - The UK has now implemented new cost-effective ways of protecting intellectual property through the County Courts.

INFRASTRUCTURE SUPPORT - The UK spends circa £1 billion annually on the National Institute for Health Research (NIHR) infrastructure, supporting experimental medicine research and clinical trials.

NIHR OFFICE FOR CLINICAL RESEARCH INFRASTRUCTURE (NOCRI) – NOCRI facilitates industry access to the UK’s clinical research infrastructure, from early-stage collaborative research through to contract clinical trials.

Going Global


CRACKING GLOBAL MARKETS


UK goes nuts for Brazil

During Hospitalar 2011, Abimo, the Brazilian Healthcare Trade Association, and Medilink UK, Britain’s leading healthcare organisation, signed a memorandum of understanding to develop a partnership in trade, technology, and R&D.

A year later these two healthcare organisations met again at Hospitalar (22-25 May) to discuss joint venture opportunities with British and Brazilian companies. 12 UK companies attended the mission to meet with companies, distributors, and visit two of the biggest hospitals in Brazil – Sirio Libanes and Sao Paulo Hospital - where they discussed the potential for UK healthcare products to be integrated into the Brazilian healthcare system.

The pilot is implementing six AN24s in all six of the chosen maternity units to monitor high risk pregnancies identified by the ‘Mae Curitibana’ (Curitiban Mother) program.

The maternity units, part of the Brazilian public health system SUS, are also linked to the local medical schools, allowing the project to be supported by university professors.

Monica’s monitor

Monica Healthcare, manufacturer of the first abdominal fetal ECG and uterine EMG (electromyography) monitor, the Monica AN24, has cracked the global marketplace.

Since April 2012, Monica Healthcare has signed exclusive distribution agreements with Japanese and Brazilian companies and has successfully sold the device to a hospital in Texas, USA.

The CE marked, FDA cleared Monica AN24 accurately monitors fetal heart rate, maternal heart rate, uterine activity and maternal activity, offering an alternative wireless ambulatory monitoring solution for induction, obesity, labour and delivery.

Submission to PMDA for Japanese approval has been made this year to catalyse sales. Key university hospitals in Japan are already using Monica for research and have expressed their confidence and support in the Monica AN24 for improving the quality of care provided to Japanese women.

James Bushby, sales manager from Monica Healthcare commented, “Successful entry into the Japanese market is of the highest importance for Monica, as it represents the world’s second largest healthcare market, just behind the USA. Our partnership with Toitu, the premier supplier of fetal monitors in Japan, is a significant indication of the success that we are expecting.”

The Brazilian distribution agreement with Michaelis and Petrelli, assisted through negotiations by Advanced Global Health, has led to a large pilot study in Curitiba, Brazil.

13

Going Global

CRACKING GLOBAL MARKETS

“Concluding the meeting, John Doddrell, the British Consul General in Sao Paulo and Director of UKTI in Brazil commented:

“I am delighted that the relationship between UKTI, Medilink and ABIMO has been further strengthened. There is a clear commitment from all parties to facilitate business match making opportunities and encourage partnership as much as possible. This will undoubtedly benefit companies from both countries, as well stimulating growth in the sector, and most importantly, make a tangible difference to the clinical needs of patients.”

For information regarding UK missions visit www.medilinkuk.com

Visit www.monicahealthcare.com for more information

Monica Healthcare’s Monica AN24 device

Britain thrives in assisted living

45 British companies exhibited at REHACARE this year in Dusseldorf, Germany, showcasing their technologies and services for people with disabilities, complex care requirements, and chronic conditions.

The trade fair attracted more than 50,000 visitors across four days, ranging from distributors to end-users.

The UK pavilion – supported by UK Trade and Investment and Medilink UK – hosted 17 of the British companies. With business leads in excess of £1 million, Britain’s reputation in assisted living is clear.

One exhibiting company, Dynamic Controls, successfully launched its LiNX power wheelchair control system at the exhibition.

UK Lifescience Industry Magazine14

Their system uses new load compensation techniques to give superior chair control on difficult surfaces allowing easier turning on thick carpets, and greater hold and stability on sloping surfaces.

Breathe easy Vectura, a specialist in respiratory drugs, is launching their Seebri Breezhaler for chronic obstructive pulmonary disease (COPD) sufferers in several markets.

Just days after the drug was endorsed in Japan, the European Commission has approved Seebri (glycopyrronium bromide) - a once-daily inhaled maintenance bronchodilator treatment to relieve symptoms in adults with COPD, better known as ‘smokers’ lungs’.

Ageing, urbanised populations with a legacy of smoking suffer chronic conditions, such as asthma and emphysema, which require endless prescriptions. A once-daily inhaler will improve the quality of life for thousands of COPD sufferers, aiding the reduction of breathlessness and exacerbations and improving lung function.

The European approval is based on data from the Phase III GLOW trials, which demonstrated the safety and efficacy of glycopyrronium 44 mcg (the Japanese endorsement is for 50mcg) and involved 1,996 COPD patients who required maintenance treatment.

Charlotte Walshe, CEO of Dynamic Controls, said:

“The exhibition has enabled us to engage with people from right across the globe – including the end-users themselves. Our aim is to enable users to play a full and active part in society, so we’re delighted that our ground-breaking technology has been so well received.”

“

“The studies showed that when compared to placebo, Seebri significantly improved lung function over the first four hours after morning dosing and that this benefit was sustained for 24 hours over a 52-week period.

Vectura signed a £200 million partnership to develop the product with Novartis in 2005.

A second product, codenamed QVA149, has delivered promising trial results and is likely to be filed with regulators next year. It has potential to work with Seebri as a useful combination therapy.

Dr Chris Blackwell, Chief Executive of Vectura, commented:

“The approval of this drug is a landmark and value-enhancing event for Vectura, who along with its partner, Sosei, developed the drug to a Phase II proof-of-concept before licensing it to Novartis. This approval will trigger a $10 million milestone to Vectura, along with subsequent royalty streams.”

Visit www.medilinkuk.com for more information on trade missions

For more information visit www.vectura.com

British Consul General for Dusseldorf meets with Yorkshire-based Platinum Stairlifts

Vectura’s manufacturing of clinical trial batches

British Consul General for Dusseldorf meets with British company Tomcat

Available worldwide, Touch Bionics’ new i-limb digits and wristband give greater dexterity to more people with missing fingers than ever before.

Touch Bionics was the first company to develop a prosthetic finger solution with articulating digits and since 2009 over 500 people have been fitted with their technology.

An estimated 1.2 million amputees worldwide could now benefit from the new i-limb digit technology, helping a wider range of people with partial hand amputations.

“The new finger development enables i-limb digits prostheses to be made smaller, lighter and more anatomically accurate, and are therefore suitable for a wider population, such as those with smaller hands, or whose amputations are closer to the base of the fingers,” said Ian Stevens, CEO, Touch Bionics. “The wrist-band unit provides the ability to build an i-limb digits prosthesis that has full wrist mobility and with easily interchangeable and rechargeable batteries.”

“By using i-limb digits to increase their overall ability to complete daily tasks, we see that people experience an increase in self-confidence and independence, and can benefit by being able to return to work or to their favourite pastimes and hobbies,” said Stevens. “Our goal as a company is to maximise the number of people that can experience these benefits, and the developments that we have announced today take us closer to that goal.”

Earlier this year, Touch Bionics attended Brazil’s trade fair, Hospitalar, to showcase their new technology and meet with their distributor Blumenthal Disitribuidora.

“Before i-limb digits became available all Brazilian patients had to use passive or mechanical prosthetic solutions, but now they can benefit from the electronic articulating fingers invented by Touch Bionics. Our workshops are ready to provide information and training to all Brazilian patients and practitioners interested in Touch Bionics’ products,” said Jairo Blumenthal of Blumenthal Disitribuidora.

UK Lifescience Industry Magazine15

Bionic finger points to better future

Going Global

For more information visit www.touchbionics.com

Touch Bionics’ i-limb digits


Following a lengthy consultation by the European Commission, the reform of the Medical Device Directives is set to enter the European Parliament, following the publication of the ‘Formal Proposal’ on the 27 September. This proposal sets out a number of changes to the system and will now move to the Parliament for MEPs to discuss.

Whilst the revision of the Directives has been underway for a number of years, the current changes do come against a backdrop of high profile failings. The recent PIP scandal highlighted the need for industry, regulators and healthcare providers to work together and improve the system to ensure safe treatments for patients.

The Formal ProposalThe proposal contains a number of changes to the system, which are largely supported by the medical technology industry.

Key changes that will have an effect on the market are based around the following areas:

Reform of the Medical Device Directives Enters European Parliament

The planned changes are intended to make the system more consistent and transparent across Europe for patients and clinicians. These measures will address the recent criticisms of the regulatory regime and allow patients and clinicians access to medical devices performance data.

Industry’s recommendations on how to improve the system informed ABHI’s submission to the Science and Technology Select Committee Inquiry on the regulation of medical implants. It sets out a vision for the future of medical device regulation and put forward a number of changes that are included in the European Commission proposal.

Industry Position Despite welcoming the majority of the proposal, industry has warned against certain aspects. Included in the proposal are measures to slow down the introduction of ‘novel devices’ by introducing a mechanism that will require certain devices to be assessed by a panel of experts before they are released onto the market.

ABHI is opposed to this measure as it does not have a clear benefit for patients and will only serve to slow down the introduction of potentially life saving technologies. This measure will also be unnecessary if the current system is implemented more consistently and competent authorities’ performance is closely monitored.

ABHI will be working with other European associations to reform this measure.

UK regulators The Medicines and Healthcare products Regulatory Agency (MHRA) has welcomed the formal proposal and supports the recommendations put forward. They also oppose the establishment of a new body charged with checking novel devices.

Crucially for the medical technology industry, the UK Parliament’s influential Science and Technology Select Committee recently completed their report on the regulation of medical implants. The report acknowledged that the fundamental principles of the European system of medical device regulation are sound and there is no benefit in moving to pre-market approval or an FDA type system. ABHI chief executive, Peter Ellingworth, and executive director of technical and regulatory policy, Mike Kreuzer, appeared before the committee in June of this year to outline industry’s vision for the future of medical device regulation. The Committee published their report earlier this month where they supported many of the recommendations put forward by industry.

This endorsement from the Committee is crucial for the UK Government as they negotiate the changes that will take place. This report gives Earl Howe, UK Health Minister, a clear mandate for negotiations on the directives.

The Future? Even with the formal proposal, the process of reforming the

system is by no means complete. There are individuals in

European Parliament that believe the system needs to go

beyond what is in the proposal. ABHI will work with MEPs and

policy makers to help deliver a system of regulation that delivers

modern, safe and effective treatments to patients.

� Increased scrutiny of the market

� Reform of the notified body system

� Vigilance co-ordination

� Standards and guidelines

� Transparency

� Traceability and UDI

� Clinical data

� Governance

� Stakeholder involvement

� Reprocessing of single-use devices

� Economic operators

www.abhi .org.uk

Association of British Healthcare Industries

250 Waterloo Road, London SE1 8RDT (020) 7960 4360 E [email protected]


Following a lengthy consultation by the European Commission, the reform of the Medical Device Directives is set to enter the European Parliament, following the publication of the ‘Formal Proposal’ on the 27 September. This proposal sets out a number of changes to the system and will now move to the Parliament for MEPs to discuss.

Whilst the revision of the Directives has been underway for a number of years, the current changes do come against a backdrop of high profile failings. The recent PIP scandal highlighted the need for industry, regulators and healthcare providers to work together and improve the system to ensure safe treatments for patients.

The Formal ProposalThe proposal contains a number of changes to the system, which are largely supported by the medical technology industry.

Key changes that will have an effect on the market are based around the following areas:

Reform of the Medical Device Directives Enters European Parliament

The planned changes are intended to make the system more consistent and transparent across Europe for patients and clinicians. These measures will address the recent criticisms of the regulatory regime and allow patients and clinicians access to medical devices performance data.

Industry’s recommendations on how to improve the system informed ABHI’s submission to the Science and Technology Select Committee Inquiry on the regulation of medical implants. It sets out a vision for the future of medical device regulation and put forward a number of changes that are included in the European Commission proposal.

Industry Position Despite welcoming the majority of the proposal, industry has warned against certain aspects. Included in the proposal are measures to slow down the introduction of ‘novel devices’ by introducing a mechanism that will require certain devices to be assessed by a panel of experts before they are released onto the market.

ABHI is opposed to this measure as it does not have a clear benefit for patients and will only serve to slow down the introduction of potentially life saving technologies. This measure will also be unnecessary if the current system is implemented more consistently and competent authorities’ performance is closely monitored.

ABHI will be working with other European associations to reform this measure.

UK regulators The Medicines and Healthcare products Regulatory Agency (MHRA) has welcomed the formal proposal and supports the recommendations put forward. They also oppose the establishment of a new body charged with checking novel devices.

Crucially for the medical technology industry, the UK Parliament’s influential Science and Technology Select Committee recently completed their report on the regulation of medical implants. The report acknowledged that the fundamental principles of the European system of medical device regulation are sound and there is no benefit in moving to pre-market approval or an FDA type system. ABHI chief executive, Peter Ellingworth, and executive director of technical and regulatory policy, Mike Kreuzer, appeared before the committee in June of this year to outline industry’s vision for the future of medical device regulation. The Committee published their report earlier this month where they supported many of the recommendations put forward by industry.

This endorsement from the Committee is crucial for the UK Government as they negotiate the changes that will take place. This report gives Earl Howe, UK Health Minister, a clear mandate for negotiations on the directives.

The Future? Even with the formal proposal, the process of reforming the

system is by no means complete. There are individuals in

European Parliament that believe the system needs to go

beyond what is in the proposal. ABHI will work with MEPs and

policy makers to help deliver a system of regulation that delivers

modern, safe and effective treatments to patients.

� Increased scrutiny of the market

� Reform of the notified body system

� Vigilance co-ordination

� Standards and guidelines

� Transparency

� Traceability and UDI

� Clinical data

� Governance

� Stakeholder involvement

� Reprocessing of single-use devices

� Economic operators

www.abhi .org.uk

Association of British Healthcare Industries

250 Waterloo Road, London SE1 8RDT (020) 7960 4360 E [email protected]


Coughing up the goods

New consumer healthcare company infirstHEALTHCARE is enhancing existing medicines, focusing on the most prevalent health conditions that need better cures.

“Our aim is to look at existing medicines and actives and make them better,” explains infirst CEO Manfred Scheske, who was previously President of GlaxoSmithKline’s $3 billion European consumer healthcare business. “The over-the-counter market is now worth around $90billion worldwide and yet there has been very little innovation to improve products that are already available.”

The first product is a cocoa-flavoured medicine for the treatment of cough and cold - one of the largest segments of the global over-the-counter market.

Cough affects over 800 million patients worldwide, with an estimated 12% of the general population (7.5 million in the UK), experiencing the symptoms regularly.

Expected to be available for the winter flu season in late 2013, this medicine is to be an effective, non-narcotic, non-opioid treatment of cough.

Next in line is an ibuprofen-based, omega lipids infused product for the treatment of inflammatory pain. This drug is expected to deliver much better pain relief for these specific conditions than existing products.

“We talked to many healthcare practitioners who confirmed the need for new, improved options for the treatment of cough and pain that are safe and cost-effective”, explains Manfred Scheske.

“Feedback from consumer research has also overwhelmingly confirmed the need for new products that have natural ingredients, such as cocoa, that can be combined with existing safe medicines to deliver an enhanced outcome for the patient.”

infirstHEALTHCARE currently has a license agreement with a key strategic partner in the US.

From days to weeks

Biotech company Novozymes Biopharma has launched a technology that could reduce drug dosing frequencies from days to weeks.

Patient hospitalisation for people that have forgotten to take their medicine is costing the US healthcare system an estimated US$300 billion in avoidable medical spending annually.

Reducing the frequency of drug administration could improve

EnhancementMAKING MEDICINE BETTER

Novozymes Biopharma’s image illustrating albumin technology

For more information contact Manfred Scheske, infirstHEALTHCARE Tel: +44 (0)207 1536570


patients’ quality of life and significantly reduce healthcare costs globally.

Novozymes Biopharma’s technology gives pharma companies greater flexibility in defining the amount of time a drug stays active and effective in a patient’s body.

“Albufuse® Flex and Recombumin® Flex represent a simple and cost-effective platform for the production of proteins with extended circulatory half-life. The platform offers pharmaceutical companies the potential to enhance patient quality of life and meet specific medical needs,” says Dr. Dave Mead,

Enhancement

Business Development Director at Novozymes Biopharma.

Half-life refers to the duration a drug remains active in the body and Novozymes’ technology extends certain drugs’ duration significantly. It is the only half-life extension platform that has been developed using an abundant protein already present in the human body, offering a natural, low-cost and safe molecule.

Since the technology was patented and introduced to the market, Novozymes has successfully partnered with GlaxoSmithKline (GSK) and TEVA Pharmaceuticals who have Novozymes’ albumin technology-enabled protein drugs

in pivotal Phase III clinical studies, which are expected to be complete by next year.

Enhancement

19

Novozymes Biopharma’s Recombumin®

Novozymes Biopharma’s image illustrating albumin technology

For more information visit www.daystoweeks.com

20

Digital diary aids care

A user-driven touch screen electronic device, UroDiary®, is set to better the diagnosis and treatment of Lower Urinary Tract Symptoms (LUTS).

LUTS refers to a range of urinary problems that can significantly impair the quality of life for sufferers. Effective treatment requires clinical evidence on frequency of urine volumes passed and urgency, which is typically recorded using paper diaries.

Use of such diaries is infrequent outside specialist services due to limited experience in primary care and the difficulty of interpreting the raw, variable data.

A potential solution to these problems, UroDiary® is being developed and trialled by ELAROS 24/7 Ltd (Electronic LUTS And Remote Observation Service), using funding awarded to Devices for Dignity (D4D), Medical Devices Technology International (MDTi), Medipex and RTC North through the Engineering and Physical Science Research Council (EPRSC).

Informed by NICE guidelines on the identification and management of LUTS, UroDiary® is used by the patient to record times, volumes passed, and the desire to urinate. Once recorded, data is downloaded to the GP’s computer system for data visualisation, interpretation and patient management.

UroDiary® is portable, more discrete than writing in a diary, and makes data easily traceable and transferable between healthcare providers. Simple data capture, analysis and quicker diagnosis will potentially save the NHS £66 million through reduction in referrals to secondary care and diagnostic costs.

Future watch


UroDiary®

prototype

Contact Medical Devices Technology International: [email protected] www.mdti.co.uk

Contact Devices for Dignity: [email protected] www.devicesfordignity.org.uk

POTENTIAL HEALTHCARE GAME CHANGERS

Visit www.renfrewgroup.com for more information

21

Diabetes drug delivery discovery

A circuitless artificial pancreas could herald the end of multiple insulin injections for type 1 diabetes sufferers.

Renfrew Group International (RGi) and professors from De Montfort University are collaborating to develop an artificial pancreas - an implantable device that uses a novel polymeric gel to automatically control the delivery of insulin into the peritoneum.

Type 1 diabetes sufferers using current treatment methods are at risk of over or under medicating. An automatic internal regulator could put an end to hourly monitoring of blood glucose levels, giving greater quality of life to millions.

Funding is required to complete this device’s study and to undertake pre-clinical trials tests, which would catalyse the development of an advanced first-generation artificial pancreas.

“Professor Taylor from De Montfort University commented:

“We have reached a critical point in the development of a fully implantable device, which is one of the essential requirements for the success of an artificial pancreas and could ultimately improve lives immeasurably for diabetics worldwide.”

Implantable artificial pancreas prototype

Future watch


KnowledgeTransferNetwork

HealthTechand Medicines

Building a Healthy Nation through Business Innovation

Technology Strategy BoardDriving Innovation

Assisted Living UK Capabilities and Opportunity Report and WebsiteThe application of technology to facilitate the delivery of health and social care has developed rapidly in the past 15 years and in Assisted Living a portfolio of products and services are now available to be prescribed for a patient by the statutory services or available to be selected by them. The ALIP programme has commissioned a report of the Assisted Living UK capabilities and opportunities which forms a ‘virtual catalogue’ of such products and services currently in existence. The virtual catalogue contains all the examples of assistive technology, telecare, telemedicine, telehealth, telehealthcare, e-health and m-health developed to date.

www.healthktn.org/capabilitymap

This report is designed to stimulate and support the development and uptake of assisted living products and services by reporting on existing care needs and provision, identifying existing assisted living activity and suppliers and identifying sources of expertise. The analysis of the data then provides an initial guide for those in the public sector who are tasked with introducing assisted living services in their region and for organisations in the voluntary and private sectors who feel there is an opportunity to develop assisted living products and services.

Benefits of Membership

By joining the Health KTN, members can connect with others in the industry, enhance career prospects and broaden their networks as well as being kept informed with newsletters and events updates. Information on all of our ‘Priority Areas’ and ‘Groups’ can now be found on the portal. We encourage new members to join our priority areas and groups to seek new business and research partners both online and in ‘real-time’ at our events and the KTN team is available to support as appropriate.

www.innovateuk.org/healthktn

You can contact the Health KTN by email:[email protected]



Innovation depends on an intimate knowledge of technology and close relationships with subject experts on one hand, and a breadth of contacts and an overview of the supply chain on the other.

The HealthTech and Medicines Knowledge Transfer Network is a single front door through which members can find all the expertise and support they need across the innovation chain, from first idea to patenting and packaging intellectual property, finding academic and industrial partners for product development and manufacturing scale-up, meeting regulatory standards, and getting access to market.

The HealthTech and Medicines KTN also helps members to access funding from the Technology Strategy Board for prototype development and proof of concept work.

Membership of the KTN provides access to a dynamic, UK-wide knowledge transfer network covering all aspects of medical devices, diagnostics, and medicines. In addition, the KTN works with these communities, actively promoting sharing of knowledge, building

Members of HealthTech and Medicines KTN get an Innovation Boost

l Potential practitioner network into industry and industry friendly academia

l Technology Strategy Board, National and EU funding competitions

l Impartial advice and access to the full KTN team

l Key individuals within the community – putting you in touch with the right partners for forming collaborations

l Networking opportunities and events

Membership of the KTN provides access to:

value chains and suggesting possible collaborations and partnerships. It is also involved in developing international networks, supporting business engagement in the US, China, Japan and Europe.

The KTN has set up specialist groups in areas including Advanced Wound Management, Assisted Living, Clinical Trials, Regenerative Medicines, Healthcare-Associated Infections and Stratified Medicines to help companies home in on the particular resources they need to address any of these areas.

Led by key opinion leaders, these specialist groups bring researchers, entrepreneurs, companies, clinical and regulatory experts together to identify opportunities, flag up potential roadblocks and foster new partnerships. Backing up these meetings, the KTN’s innovation platform features online tools that enable partners to explore projects and issues they are working on together.

For more information and how to engage with the HealthTech and Medicines KTN community visit:


Knowledge TransferOpening Doors to wider networks of people/organisations

Access to Funding

Identify and influence new and existing

sources of funding

Connecting PartnersBringing together and facilitating collaborations with a common goal


KTN


Access to Funding


sources of funding



KTN


Access to Funding


sources of funding



KTN

The HealthTech and Medicines KTN supports business innovation through partnerships, funding and knowledge transfer:



Building a Healthy Nation through Business Innovation

Technology Strategy BoardDriving Innovation

Assisted Living UK Capabilities and Opportunity Report and WebsiteThe application of technology to facilitate the delivery of health and social care has developed rapidly in the past 15 years and in Assisted Living a portfolio of products and services are now available to be prescribed for a patient by the statutory services or available to be selected by them. The ALIP programme has commissioned a report of the Assisted Living UK capabilities and opportunities which forms a ‘virtual catalogue’ of such products and services currently in existence. The virtual catalogue contains all the examples of assistive technology, telecare, telemedicine, telehealth, telehealthcare, e-health and m-health developed to date.

www.healthktn.org/capabilitymap

This report is designed to stimulate and support the development and uptake of assisted living products and services by reporting on existing care needs and provision, identifying existing assisted living activity and suppliers and identifying sources of expertise. The analysis of the data then provides an initial guide for those in the public sector who are tasked with introducing assisted living services in their region and for organisations in the voluntary and private sectors who feel there is an opportunity to develop assisted living products and services.

Benefits of Membership

By joining the Health KTN, members can connect with others in the industry, enhance career prospects and broaden their networks as well as being kept informed with newsletters and events updates. Information on all of our ‘Priority Areas’ and ‘Groups’ can now be found on the portal. We encourage new members to join our priority areas and groups to seek new business and research partners both online and in ‘real-time’ at our events and the KTN team is available to support as appropriate.


You can contact the Health KTN by email:[email protected]




Made in the UKFrom technical textiles to medical marvels

Nottingham technical textiles company Capatex Ltd is predicting a 15% increase in turnover resulting from expansion into the healthcare market.

Aided by a £14,000 innovation grant part-financed by the European Regional Development Fund (ERDF), Capatex researched alternative markets for its manufacturing facilities and saw potential in the medical market. Capatex Medical has since been launched, with the grant also being used to establish a quality management system and CE marks for the new Capatex Medical lines.

The birth of Capatex Medical is welcome news for Nottingham, helping return the city to a centre of manufacturing excellence whilst providing employment for an estimated 17 people at its New Basford facility.

Adding to its established agriculture, horticulture, landscaping, military, automotive and industrial lines, Capatex now supplies branded medical devices and continence products to the NHS, distributors, retail, care homes and by mail order direct to users.

Innovation in product design has been key to Capatex Medical’s early success, enabled by the close relationships developed with researchers at De Montfort University to expand the medical range.

Hands-on improvement

With nearly 30 years’ experience, Corin Group – an expert in orthopaedic implant technology – continues to manufacture its products in the UK.

Having direct operations in five global orthopaedic markets and distribution arrangements in over 30 countries, Corin uses research, continuous improvement programmes, and a commitment to responsible innovation to keep ahead.

ResearchHaving developed a worldwide network of research associations with leading universities, research institutes and industrial partners, Corin is able to access expert advice and equipment. For instance, Corin can test the safety and efficacy of all its prostheses with advanced computer simulation technologies utilised to model and predict the lifecycle of prostheses. Kinematic analysis and mechanical simulations are also used to replicate patients’ behaviour and ensure that product performance is optimised over the life of the implant. Research into new materials allows Corin to offer world’s first implant technologies designed to enhance longevity and performance. In 2011, Corin set up an internal test laboratory to allow better understanding of implant testing, which gained UKAS accreditation.

Much research focuses on improving quality of life in a society

“Capatex’s Managing Director Gabriel Strauss commented:

“We are determined to keep manufacturing here in Nottingham and use the local supply chain, and the support from Medilink has been invaluable. All our medical incontinence underwear range is made in the city using fabrics sourced locally. We now intend to expand the business by introducing new products, and with the continued guidance from Medilink, expect to be drawing on further local university research and innovation to do this.”

KEEPING MANUFACTURING AT HOME

Gabriel Strauss, Managing Director, Capatex with product

Visit www.capatex.com for more information


of increasingly active arthritic patients – minimising wear, addressing aseptic loosening, and reducing stress shielding that causes bone loss around implants.

Corin has successfully gained external grant funding from the Technology Strategy Board, NIHR i4i and EU funding, proposing projects to improve implant design, patient matched instrumentation for knee surgery, advanced CT designed implants (TriFit TS™ and MiniHip™) and the Unity Knee™.

Continuous improvementSince implementing their continuous improvement scheme in 2009, the generation and completion of ideas is encouraged and over 400 improvement ideas have been raised by employees, with just under 75 per cent of these being implemented.

An ideas board was developed and has been rolled out across the whole operational site, allowing improvement ideas to be managed internally by operators. A database system was implemented to log, amend and sign off ideas, alongside the enablement of various reporting features for management information.

A combination of display boards, presentation and touch screen

systems have been implemented in a central area in order to add value to the operator experience, increase recognition levels and promote improvement discussions.

The scheme has been so successful that Corin recently hosted a ‘Member Connect’ event through EEF – the manufacturers’ organisation for UK manufacturing companies. This provided a great opportunity for companies to learn

and obtain ideas to develop their own schemes.

Made in the UK

Visit www.coringroup.com for more information

Corin’s New Surgeon Resource Hub app for the ipad.


Part-time postgraduate programmes

Cranfield Health offers part-time Executive MSc programmesideally structured to enable professionals to remain inemployment whilst studying to advance their career.

Each programme is delivered in partnership with a professional bodyand offers those working in the healthcare sector or related disciplinesthe opportunity to gain a formal qualification in recognition of theirskills, expertise and knowledge.

Programmes comprise eight taught modules, an integrating portfolioand a research project that can be based upon an issue relating toyour workplace – a great benefit to you and your employer.

Cranfield is a wholly postgraduate university located midway betweenOxford and Cambridge, offering a mature and professional environment inwhich to advance your career.

Jess Pagan, MSc Graduate2012

"Studying Clinical Research expanded my knowledgeand I feel a lot more confident having a thoroughunderstanding of the ethics, regulations and rulesinvolved.

This course was also extremely helpful with my joband allowed me to apply what I learnt to a real worldsituation.”

E: [email protected] T: +44 (0)1234 758008

• Clinical Research Start date: January 2013

• Quality Management in Scientific Research and Development Multiple start dates throughout 2012/2013

• Medical Technology Regulatory AffairsMultiple start dates throughout 2012/2013

For even greater flexibility some modules are available to study asindividual short courses.

Specifically designed for professionals wishing to comfortablycombine work and study, the programmes are delivered over threedays per module – minimising time away from the workplace.

www.cranfield.ac.uk/health/ls1

Executive MSc Programmes:

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Excellence in Deviceand Packaging Testing

t +44 (0)8454 588924 f +44 (0)1303 813952 e [email protected] www.met.uk.com

Medical Engineering Technologies Ltd • Yew Tree Studios,Stone Street, Stanford North, Ashford, Kent TN25 6DH, UK


Lean machines boost sales

GE Healthcare continues to invest and manufacture from its Welsh site, supplying customers globally with high quality, customised and cost effective cell technology products.

One device in particular is picking up worldwide recognition and business. Rick Dool, Global Consumables General Manager, explains why:

“Our FTA data capture device enables the safe and simple collection of blood, urine or cheek cell samples for DNA analysis and doesn’t require the sample to be refrigerated, providing customers with added flexibility. This product is already being used by police forces and governments globally, and has been recognised as leading in genomics, forensics and human identification.

FTA products are technically relatively simple: specially coated paper attached to card, which protects the exceptional properties of the paper and is then enclosed in a plastic device to allow safe handling and storage without contamination. It is the customisation for each client and the stability of the product at room temperature that makes it a unique product.

Key to GE’s global success with this product was the quality of the market research, R&D, machinery, and the continuous improvement and efficiency procedures put in place.

After the initial market research and R&D phase, GE invested money in the Cardiff facility, building one process, in-house, that can manufacture hundreds of different shapes and sizes to fit customers’ needs with each one having a unique printed design and logo.

Barcode control methodology, similar to that used by supermarkets, is used and all the equipment is located within a controlled environment room, minimising DNA contamination.

Striving to be more efficient than competitors, a series of calculations were carried out showing room for further efficiencies, reducing the number of operator manipulations required. Multiple sample production has been reduced from 2.5 hours to 20 minutes as a result.

Constant improvements have reduced the time taken for GE Healthcare to process an order from 63 to 35 days, which translate at an estimated $1.4 million extra sales predicted for 2013.

GE Healthcare’s FTA Paper enclosed in plastic storage device

Visit www3.gehealthcare.co.uk for more information

Made in the UK


DNA to identify early signs of breast cancer

A simple blood test may be a more accurate way to test for the early signs of breast cancer than using mammograms, say University of Leicester researchers.

Leading the study to determine whether DNA in blood could show early signs of breast cancer, the researchers also hope to detect whether patients are likely to relapse and what drugs their particular type of tumour will respond to.

This pioneering new clinical study, funded by Cancer Research UK in collaboration with the University of Leicester and Imperial College

London, is taking place in the UK’s largest breast screening clinic at Charing Cross Hospital, London.

Researchers will take blood samples from women attending the clinic and compare the DNA in the blood of women who are diagnosed with breast cancer with those that do not have cancer to see what DNA markers are consistent.

Dr Jacqui Shaw, principal investigator from the University of Leicester, said: This exciting research means we could one day have a blood test that detects the very early signs of cancer meaning women could have an annual blood test rather than breast screening. This would remove any worry and anxiety for women who are called for further investigations after a mammogram only to find they don’t have cancer.

Real-time diagnosis for cervical cancer

Zilico, a diagnostics company spun out of Sheffield University, is developing a device to provide real-time results for women undergoing cervical cancer screening.

Cervical cancer affects around 500,000 women worldwide each year and is responsible for 300,000 deaths. Under current screening practices in the UK, a woman will

“As things stand we aren‘t able to monitor breast cancer patients after they’ve had surgery and treatment - which is like treating diabetes but not measuring blood sugar levels. The new blood test could change that.“

Other projects are looking to see whether a blood test can detect early signs of other cancers such as bowel and lung.







have a Pap smear or LBC test every three to five years. If the test is positive, she will be referred to a colposcopy clinic for a detailed cervical examination.

The system consists of a portable hand-held device, a single use disposable sleeve and docking station. This system is safe, painless, and accurate.

The technology used, called electrical impedance spectroscopy, can measure the resistivity of cells and so detects changes as cells progress from normal to precancerous and then to cancerous.

Zilico’s new device has two applications: the first is used within the referral population and could help reduce the number of biopsies taken. The second, which is under development, will be positioned as a screening device, helping reduce the subjectivity and time taken with current tests.

The referral application completed a pivotal European trial of 400 women in 2011 across three hospitals in the UK and Ireland. The company has been disseminating these results at key scientific meetings across the world.








Meeting the unmet

“Dr Penny Attridge, Senior Investment Director at SPARK Impact and Manager of The North West Fund for Biomedical, said:

“Cervical cancer is the second most common cancer in women under 35 and we feel this technology really has the potential to become a successful diagnostic tool for this cruel disease.”

RESPONDING TO UNMET CLINICAL NEEDS

Aiding the project’s progression, Zilico has received £750,000 investment from The North West Fund for Biomedical, managed by SPARK Impact, and a further £235,000 from new and existing investors, including Fusion IP plc.

The investment will be used to complete the manufacture of commercial devices and to establish its route to market within the EU and other territories.

Zilico’s ZedScan™I

For more information visit www.zilico.co.uk

Meeting the unmet


DNA to identify early signs of breast cancer

A simple blood test may be a more accurate way to test for the early signs of breast cancer than using mammograms,

claim University of Leicester researchers.

Leading the study to determine whether

DNA in blood could show early signs

of breast cancer, the researchers

also hope to

detect whether patients are likely to relapse and what drugs their particular type of tumour will respond to.

This pioneering new clinical study, funded by Cancer Research UK in collaboration with the University of Leicester and Imperial College London, is taking place in the UK’s largest breast screening clinic at Charing Cross Hospital, London.

Researchers will take blood samples from women attending the clinic and compare the DNA in the blood of women who are diagnosed with breast cancer with those that do not have cancer to see what DNA markers are consistent.

Dr Jacqui Shaw, Principal Investigator from the University of Leicester, said: “This exciting research means we could one day have a blood test that detects the very early signs of cancer meaning women could have an annual blood test rather than breast screening. This would remove any worry and anxiety for women who are called for further investigations after a mammogram only to find they don’t have cancer.

“As things stand we aren‘t able to monitor breast cancer patients after they’ve had surgery and treatment - which is like treating diabetes but not measuring blood sugar levels. The new blood test could change that.“

Other projects are looking to see whether a blood test can detect early signs of other cancers such as bowel and lung.

Contact the University of Leicester for more information: [email protected] www2.le.ac.uk


Centre calls for patient-specific medical projects

A world-renowned design and innovation consultancy and research centre can produce individualised medical products and is calling for companies to utilise their expertise.

Their most recent project provides patients with more realistic and better fitting breast prostheses. It has been developed by the Patient-Specific Medical Design Centre in collaboration with clinicians at Morriston Hospital, Swansea, who identified the need.

The technique produces breast patterns and tools, which construct a silicon breast prosthesis bespoke to each patient through the use of advanced digital design and manufacturing processes.

Where possible, prostheses are based on the remaining breast shape, restoring the missing breast weight to help prevent post mastectomy posture problems.

Through a combination of design, advanced manufacturing technologies, and clinical knowledge, the centre tailors products to individual patients’ needs and provides a key link between medical practice and business.

The partnership combines the medical and technical expertise of the National Centre for Product Design and Development Research (PDR) at Cardiff Metropolitan University and clinical partnerships such as the Centre for Applied Reconstructive Technologies in Surgery (CARTIS).

Meeting the unmet

For more information visit www.pdronline.co.uk

“Dr Peter Dorrington, Industry Lead at the Patient-Specific Design Centre, said:

“The technology provides patients with a bespoke breast prosthesis, rather than having an off-the-shelf product. This could prove hugely important to post-mastectomy patients, particularly in terms of their overall well-being and confidence levels, which is a vital element of the recovery process.

“This technique has also illustrated how computer-aided methods are able to offer a cost-effective alternative to the traditional labour-intensive techniques, by reducing the length of patient consultations, and number of patient visits, while also providing a more flexible and repeatable method of working.”


Earlier this year, Dr Anstiss began responding to people’s questions about depression online as part of his work with Black Dog Tribe (a social website for people with mental health issues, set up by comedienne Ruby Wax) and became interested in how the internet and social media might be used to support more individuals and organisations.

These experiences led Dr Anstiss to develop mi-wellbeing - a customisable, interactive, multi-media health and well-being portal that has been built in open-source software.

The primary aim of mi-wellbeing is to guide people towards improved

psychological health and well-being. Among several features, users of the product can create and update an online personal well-being plan and track changes in their well-being over time.

mi-wellbeing was initially set up to help NHS Trusts (such as The West London Mental Healthcare Trust) offer quality controlled, accessible health information and exercises to their managers and staff, but has already proved useful in helping Macmillan Cancer Support run online well-being groups for people with cancer and cancer survivors.

With the support of a South East Health Technologies Alliance (SEHTA) telecare grant, Dr Anstiss

has been able to develop mi-wellbeing further and is now seeking additional funding to support growth of the concept and business.

He is planning to develop a range of customised versions for people with different health conditions, such as diabetes, chronic pain, depression and CHD, as well as for use in different settings, including schools and colleges, leisure centres and prisons.

To find out more about mi-wellbeing visit: www.appliedwellbeing.com

Well connected for wellbeing

Strategic Health Ltd has launched an e-health unit – Applied Wellbeing – to develop health and well-being applications, online resources and courses for individuals, groups and organisations.

Led by Dr Tim Anstiss, the aim is to protect and improve people’s psychological wellbeing and resilience via a mixture of scientific and proven methods from clinical, health and positive psychology, coaching psychology, improvement science and motivational interviewing.

“By helping people to improve their personal psychological health and well-being, we reduce the likelihood that they will become ill, whilst improving their quality of life and performance in different aspects of living,” explains Dr Anstiss. “In a world where long term conditions, including depression, are becoming more common, positive non-medical approaches to well-being improvement have an increasingly important role to play. And the web is where many people will go for help in this area.”

It’s all in the hipsJoint replacement surgery is not a new phenomenon, however how it is performed – via an anterior or posterior approach – is a hot debate among surgeons.

Difference in surgical techniqueThe traditional posterior approach to hip replacement surgery involves going through the back, splitting the buttock muscles and peeling back the hip muscles to access the joint. When surgeons employ the anterior approach, they enter the hip through the front part of the joint.

“When we take the anterior approach, we don’t detach or remove any muscles,” says Mr Jamie Wootton BSc MB BS FRCS, consultant orthopaedic surgeon specialising in joint replacement and joint reconstruction at the Wrexham Maelor Hospital in North Wales. “From a recovery standpoint, that means less pain and quicker return to function.”

The anterior approach is minimally invasive because the procedure can be performed through a 10 centimeter or less incision. Without muscle disruption, patients can return to regular activity quicker.

Imaging technologyUsing real-time X-ray guidance, the anterior approach allows surgeons to place the implant more precisely. It also aids the surgeon’s measurement of both sides of the leg, which if done inaccurately can lead to hip replacement failure. “With this equipment, you are watching the procedure on X-ray as you go in, so you can see where the implant is going and get it exactly where you want it,” says Mr Wootton. “This gives you better control of their leg length.”

Why the procedure isn’t more widespreadThe anterior approach is less invasive but it is also less known. “You have to be committed to doing some extra training to be able to perform it safely and consistently” says Mr Wootton. “The other issue is that you need to have a specialised operating table/extension to allow you to get to the hip from the front and manipulate the patient’s legs during the procedure. Historically, these support devices have been expensive, complex and cumbersome - which is why we have developed ‘FLOTE’ - our own low-cost, portable device to assist surgeons in adopting this technique.”

Patient and cost benefits Although extra training is required for surgeons to adopt the anterior approach, Mr Wootton hasn’t experienced any complications, nerve problems or dislocations from patients undergoing anterior hip replacements.

“We’ve experienced several whole days decrease in the length of stay, from 6.8 days to just over 2,” says Mr. Wootton. “All the way around, the short-term recovery has been quicker and there haven’t been any complications.”

“As patients find out more about the advantages associated with anterior hip replacements, they will demand that type of procedure and drive it forward”, says Mr Wootton.

More information about the technique and the FLOTE technology can be found via Francis Lamont Innovation Ltd, www.fliuk.com


33

Meeting the unmet

Francis Lamont Innovation’s FLOTE device


Raising the standard

Years Ahead Partnership and Newcastle University, through its Changing Age Initiative, have produced a publication of their feasibility study, ‘Raising the Standard’, aimed at establishing a trusted product rating or approval scheme for independent living and mobility products.

The initiative, which aims to increase awareness and confidence amongst consumers, is being undertaken through Years Ahead’s not-for-profit Better Living Trust.

A recent study of the mobility market by the Office of Fair Trading (OFT) concludes that unfair sales practices exist and consumers do not shop around, often basing their purchase decisions on very limited information.

Dr Maggie Winchcombe OBE, a leading occupational therapist and a founder of Years Ahead, commented:

“This report is a timely and important contribution to the development of the emerging Assistive Technology market.”

Partners are seeking funding and support to move to the next phase, which will look at the design and operation of the rating scheme.

Stopping skin tear suffering

Skin tears are a common occurrence among the elderly but are relatively unheard of due to lack of research or any medical classification.

Skin tears happen when elderly people with ‘thinning skin’ walk into unseen objects in the home, trip on the stairs or are moved too quickly and come in to contact with rough materials. The top layer of skin on the lower legs and forearms can be completely removed or flapped back.

In 2008, entrepreneur Peter Thornton and GP Dr Jemima Stilgoe approached Dr Roy Powell, a researcher and statistician, with a solution to this clinically unmet need.

Their idea of armoured but comfortable and flexible protective stockings and sleeves will become the subject of a research trial with Dr Powell’s team. Having been awarded £250,000 by the National Institute for Health Research (NIHR) under its Research for Patient Benefit Scheme, the trial will start in January 2013.

Thinning skin is not classified as a medical condition because it is not seen as such in its own right. It is primarily due to ageing, with all people over 60 suffering gradual deterioration. It’s made worse if the sufferer takes steroids, is a smoker, or has experienced excessive exposure to the sun.

The proposed solution is impact and abrasion resistant stockings and sleeves made from a specially

developed hard aramid fibre using a special construction method. Peter Thornton and his business partner Nick Pitts worked with Jan Prytherch, clinical manager – tissue viability at the Exeter Tissue Viability Clinic to develop the product and tested them in private evaluations in local care homes. There was found to be a 97% reduction in the normal number of skin tears.

Working with investors Daniel Seale and Paul Austin and through grants from Biomedical iNets and

the Devon & Cornwall Business Council for patenting

work, Peter and Nick have the products listed on the NHS supply chain and are marketing the products through Dermatuff Ltd.

The ‘STOPCUTS’ 16-week randomised control trial will take place in approximately 30 care homes situated in Exeter, Exmouth, and North Devon. 90 residents will be randomly selected; half will wear the stockings and half will be the control

group.

Dermatuff estimate circa three million skin tear accidents

per year in the UK alone. Based on these

figures, Dermatuff’s stockings and sleeves could save the NHS £1 billion per annum.

To discuss the opportunity to support or invest in the scheme, please email [email protected] or visit www.yearsahead.co.uk

View Dermatuff’s products at www.dermatuff.co.uk

Dermatuff stockings

HealthResearchWales

What can Health Research Wales do for you?• ProvideasinglecommunicationrouteforIndustry• Offersupportandguidancethroughtheresearchprocess• Signposttoadditionalsupportandfundingopportunities• Facilitate quick and easy site identification including

supportinfeasibilityassessment• Support the set up, management and delivery

ofcommercialstudiesintheNHS

Health Research Wales will be formally launched in March 2013

HealthResearchWales

The research facilitation service for Wales

Tel: +44 (0) 2920 196 816Email: [email protected] www.healthresearchwales.com

Health Research Wales has been established to facilitate the effective set-up, management and delivery of commercial clinical research in Wales. Health Research Wales supports the development of productive relationships between commercial companies, Universities and the NHS demonstrating that Wales is a great place to do research.

World’s first artificial liver to replace animal testing

A Heriot-Watt University project may drastically reduce animal testing with the development of an artificial human liver for drug testing.

Led by Dr Will Shu, and working closely with stem cell technology company Roslin Cellab, the £100,000 project, funded by the Scottish Universities Physics Alliance (SUPA) INSPIRE programme, aims to speed up the delivery of life-saving medicines to patients.

The project’s objective is to demonstrate how an artificial liver, created using human cells, could become a new testing platform for drug discovery and development.

The team is working towards creating miniature human liver tissues and, eventually, ‘livers-on-a-chip’, using novel technology that will ‘print’ the cells in 3D onto testing surfaces.

Dr Will Shu said, “If we are able to advance this technique, the medical benefits could be enormous.”

Animal testing is expensive, time-consuming and drugs that pass animal testing often fail in the expensive in-human stages of clinical trials.

“If successful, this technology will enable drug developers to test using human organ models at a much earlier stage,” Dr Jason King of Roslin Cellab commented.

“It should highlight drug failures well before they reach the clinic and help target resources towards the most promising new drug candidates.”

Projects such as Dr Shu’s are gaining international interest because the 3D cells they use outperform cells grown in 2D cultures – the standard in the drug development sector.

For more information visit www.hw.ac.uk

PHOTO BY COLIN HATTERSLEY

BioWalesWa l e s , L i f e S c i e n c e a n d t h e Wo r l d

SAVE THE DATE19th & 20th March 2013Conference & ExhibitionCardiff, Wales UK

Register your interest:[email protected]

www.biowalesevent.com


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UK Lifescience Industry Edition 5