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SPRING2015

WEST MIDLANDS

MEDILINKNEWS

Innovate UK invests millions each year in supporting businesses develop new digital products and services. They help UK businesses in every sector navigate challenges, innovate, and exploit digital technologies.

Innovate UK know the challenges that face today’s businesses and can help businesses focus on user needs, grow infrastructures, platforms andeco-systems and turn digital technlogy to their best advantage.

Find out how the Innovate UK is lighting a fire in digital innovation – watch the new video to find out about the digital economy strategy for 2015 to 2018.

CORPORATE SPONSOR:

INNOVATE UKDIGITAL ECONOMY STRATEGY 2015-18

Video produced by director, animator, Illustrator and Student Academy Award gold medal winner Kristina Yee.

LIGHTING A FIRE IN DIGITAL INNOVATION: WATCH THE NEW INNOVATE UK VIDEO

IN THIS ISSUE:

GBSLEP LAUNCH "ROADMAP" TO BOOST LIFE SCIENCESMEDILINK UK AWARDS 2015MHRA LAUNCH DEVICES ONLINE REGISTRATION SERVICE

SPRING 2015

MasterControl Inc is a global provider of quality management software solutions and services.Purchasing a Quality Management System (QMS) software solution is a major investment - one that will impact your organisation for years, perhaps even decades, to come. That's why it's important to choose a QMS provider who can support you from implementation and beyond, a true technology partner that's focused on your overall success, not just software functionality.

For more than 550 regulated companies worldwide, from small start-ups to large global leaders, MasterControl Inc. is that partner.

While enterprise quality management software solutions remain the mainstay of the business, MasterControl also provide a wide-range of comprehensive services, including quality and compliance training and consulting, for users of MasterControl software and non-users alike.

Whether you're an executive seeking to increase revenues, an IT manager with the goal of optimising efficiency, or a director of quality tasked with streamlining operations or improving quality processes like CAPA and risk management, MasterControl invite you to get to know them better.

The MasterControl solution includes much more than software; it offers regulated companies a complete information management solution across the enterprise.

MasterControl and its partner, i4DM, recently announced they will continue their roles as the quality management system providers for the U.S. FDA's Office of Regulatory Affairs (ORA).

MHRA LAUNCHES DEVICES ONLINEREGISTRATION SYSTEM The new Medicines & Healthcare products Regulatory Agency (MRHA) Devices Online Registration System (DORS) went live on the 11 February 2015.

Companies will be able to register the following devices online and manage their details directly:

• class I medical devices• systems and procedure packs• custom made medical devices• custom made active implantable devices• in vitro diagnostic devices online and manage your details directly.

The on-line Registration System has been especially designed by the MHRA to provide device manufacturers, assemblers and their authorised representatives, a simple electronic means of registering with the Agency.

Click here to login or create an account.

INTRODUCING OUR

NEW CORPORATE SPONSOR

MASTERCONTROL

To find out more about our new Corporate Sponsors MasterControl click here.

To find out more about becoming a Medilink Corporate Sponsor - click here.

SPRING 2015

GBSLEP ANNOUNCES LAUNCH OF LIFE SCIENCES COMMISSION

The Greater Birmingham & Solihull Local Enterprise Partnership (GBSLEP) has announced the launch of a new Life Sciences Commission, which will create a roadmap to achieve a world class environment and industry offer to attract life sciences to the city of Birmingham and wider region.

Chaired by Birmingham businessman Graham Silk, who is also co-founder of the Cure Leukaemia charity and Patients4Data, the commission will involve a wide range of stakeholders including hospitals and other related NHS partners, universities, industry, central government and the GBSLEP’s private and public sector partners.

Birmingham is fast becoming recognised as an important centre for the life sciences sector with its uniqueinfrastructure for accelerated clinical trials including unrivalled access to a large, diverse and stable patientpopulation, and its fast growing medical technologies cluster.

The new commission will be looking to unlock the major potential that exists to grow the life sciences sector in the Greater Birmingham region, which will be further enhanced by the opening of a new Institute of Translational Medicine (ITM) in Birmingham in June 2015.

Steve Hollis, deputy chairman of the GBSLEP, said: “The launch of the Life Sciences Commission is particularly exciting and will allow us to build on Birmingham’s current success in pioneering life sciences services in the UK. This vitally important work will accelerate the delivery of personalised healthcare for a range of major issues including cancer and liver disease.

“As well as positioning our city as a life sciences centre of excellence, helping to provide the best treatments for the improvement of the health of the nation, Birmingham’s life sciences focus will also go a long way to creating more jobs and delivering further growth for our region.”

Minister for Life Sciences, George Freeman, said: “Bringing together industry with the assets and capabilities of our universities and the NHS is not only revolutionising the way we look at getting better treatments and medicalinnovations into the health service, it boosts economic growth and creates jobs.

With its excellent universities, its infrastructure to accommodate accelerated clinical trials and its large and diverse patient population, Birmingham is in a strong position to become a hub for the life sciences, so I welcome this commission by the GBSLEP to look at how best to grow the life sciences sector in the city and the wider area.”

Graham Silk said: “The last decade has seen incredible strides forward in how new medicines and devices are treating patients, with a significant move towards personalised and stratified treatments, much of this driven by the lifesciences industry. Given Birmingham’s pre-eminence in the area of accelerated trials, its forward thinking vision in creating the Institute of Translational Medicine and with one of the largest one-hour catchment area of patients in Europe, this commission will identify and create a roadmap that will significantly assist in expanding and stimulating life sciences activity in the region. In addition, the creation of a sustainable throughput of new treatments will deliver a massive improvement to patient outcomes not only locally but across the world.

To find out more and keep up to date with the new Life Sciences Commission visit the GBSLEP website – click here.

SPRING 2015

Programme – Collaborative research and development. Scope – Innovate UK are to invest up to £6m in collaborative R&D projects that support the development and application of non-animal technologies in the UK.

This competition seeks to advance the rate of development and commercialisation of non-animal technologies and testing systems that better predict human and animal responses to, and the environmental effects of, chemicals and new molecular entities. It covers technologies that could be used in early drug, veterinary medicine, chemical and consumer productdevelopment, and suites of technologies intended to replace regulatory toxicology studies.

The aim is not purely to replace animal models with equivalent in vitro or in silico models; it is to produce better tests and systems that more accurately predict efficacy, safety and environmental effects. The range of technologies that might need to be developed or integrated to meet this challenge could include, but is not limited to, the areas below.

Biological, tissue engineering and imaging-related including: stem cell technologies/tissue engineering, next-generation sequencing and ‘omics' – genomics, epigenomics, proteomics, technologies for identifying and measuring in vitro biomarkers.Manufacturing-related including: high-throughput technologies/combinatorial chemistry, micro-structured surfaces and micro-fluidics, automation and control.Computational and mathematical methods including: mathematical modelling, computer simulation, structure-activity relationships and computational chemistry, data-mining and analysis of large complex (including historical) data sets.

Opens: 23rd March 2015. • Briefing Event: 26th March 2015. • Deadline for application: 6th May 2015 (Expression of Interest).

Investment – Proposals must be collaborative and led by a business. Innovate UK expect to fund mainly industrial research projects in which a large business partner can claim up to 50% public funding for their project costs (60% for SMEs). Innovate UK expect projects to range in size from total costs of £500,000 to £1 million.

If this grant funding competition is of interest and you would like to find out more information or discuss scoping an application please contact Matt Symonds at TBAT Innovation (matts@tbat.co.uk, 01509 670 610) quoting reference MWM.

WMAHSN SUPPORTS SPECIAL REPORT ON WEST MIDLANDS HEALTHCARE SECTOR The latest special report of BQ Magazine, which has been produced in partnership with the West Midland Academic Health Science Network (WMAHSN), focuses on the local healthcare sector and its impact on the economy.

The Next Generation of Healthcare details the industry professionals, clinicians and academics who together give the West Midlands a global presence in healthcare, life sciences and biotech. It explores the collaboration, often with input by the WMAHSN, which has been the catalyst for the sector’s remarkable growth and its array of innovations in treatments, technologies and services, all contributing to improved health and increased wealth for the region.

The report contains a round up of the latest developments in thehealthcare sector, interviews with the leading figures in the WestMidlands’ business community and profiles on the local companies who are shaping the future of healthcare. There is also a feature on the WMAHSN’s Health and Wealth Economic Summit, held in October 2014.

DEVELOPING NON-ANIMAL TECHNOLOGIES

If you would like a hard copy of The Next Generation of Healthcare, pleasecontact Sarah Millard on 0121 452 5636 or sarah.millard@wmahsn.org

SPRING 2015

KIMAL ENTERS THE FRENCH MARKETIn July 2014, Medilink member Kimal plc and Laboratoire Hydrex joined forces to create Kimal SARL, bringing together 130 years of experience delivering innovative products and services to the healthcare market.

Kimal plc are a family owned company that have delivered healthcare innovation to international customers for the last 50 years. Kimal are an international company with direct operations in the UK, Germany and now France.

The company has accumulated over 20 years of expertise in bringing customised procedural solutions to international markets. Kimal’s bespoke procedure pack product is characterised by offering outstanding customer choice and quality at a competitive price, Laboratoire Hydrex has been involved in the manufacture of medical products following their formation in 1931. Since then, the company has been engaged in the manufacture of swabs and accessories at their manufacturing facility outside Lyon. In 2002, drapes and gowns were added to their product portfolio, and more recently procedure packs.

This strategic partnership will allow Kimal and Laboratoire Hydrex to bring together their combined experience, resources and supply chain capabilities in order to offer expert local service and a broader range of products to the French healthcare market.

The partnership will focus on Hydrex’s existing procedural solutions products with Kimal’s customised procedure packs in Cardiology and Radiology.

Over the last couple years, FDA has clarified the scope of its regulation over mobile health. In the agency’s September 2013 guidance, FDA spelled out its oversight for some of the most common mobile medical apps.

Then, last month, in two separate draft guidances FDA explained the limits on its oversight of apps used for general wellness like fitness trackers, as well as apps that may be accessories to a medical device. And already in February, FDA published a final guidance deregulating medical device data systems, a category that includes numerous mobile apps.

The agency has been busy.

But one area FDA has yet to clarify is apps that guide the appropriate use of drugs. Many of those apps potentially fit the category of clinical decision support (CDS) software, an area that FDA has been planning guidance since 2011, but so far has not addressed.

To be fair, this is undoubtedly one of the most difficult guidances to write. Frankly, the number of use cases for CDS is mind-boggling. Compounding matters, creative people are coming up with new use cases on almost a daily basis. For policymakers this is both exciting and challenging.

To read the full article by Bradley Merrill Thompson of Epstein Becker & Green, P.C – click here.

He counsels medical device, drug, and combination product companies on a wide range of FDA regulatory, reimbursement, and clinical trial issues.

Mr Merrill Thompson concludes the Next Steps are:

While FDA is developing its guidance on clinical decision support software, Congress is also debating at least two different bills – the SOFTWARE Act in the House and the MEDTECH Act in the Senate– that would help clarify the rules for pharmaceutical apps. That clarification would allow the pharmaceutical industry to help doctors and patients make more appropriate use of drugs.

There is, for example, a growing body of scientific literature that suggests that mobile apps offer great potential to increase medication adherence. Non-adherence is estimated to cause approximately 125,000 deaths per year in the United States. Given FDA’s responsibility to oversee the safe and effective use of drugs, it would seem that encouraging the development of mobile apps to improve the safety of pharmaceuticals would be a high priority.

IN-DEPTH: ANTICIPATING FDA REGULATION OF PHARMACEUTICAL APPS

SPRING 2015

To find out more about Medilink member Goldcrest Labels - click here.

Goldcrest have developed a bespoke Steam Sterilisation Label in conjunction with the German Laboratory Glassware manufacturer, DURAN Group, as a key component in their multi product design award winning YOUTILITY Laboratory Bottle System.

The cap and bottle labels are supplied in tear resistant matt white polyester with a high performance adhesive. This makes the labels receptive to a wide variety of marking methods which in conjunction with colour coded collars, makes for easy bottle and sample identification.

The labels are chemically resistant and have a service temperature range from -40 to +150 centigrade but still can be easily removed when required.

The specially printed steam indicator goes from clear to black to indicate the sterilisation process has been successful, providing a vital process check.

Goldcrest supply a wide range of Chemical Indicators for Gamma Ray, Ethylene Oxide, Steam and Hydrogen Peroxide sterilisation. All systems have an “off the shelf” dot indicator but bespoke systems like the DURAN® YOUTILITY label are available on demand.

GOLDCREST SUPPLY INDICATOR LABELS FOR AWARD WINNINGYOUTILITY LABORATORY BOTTLE SYSTEM

For more information contact: Mick Bowler on 07770 737 297 or email:mick@goldcrest-products.co.uk

“Goldcrest Labels have handled the label production for the Academic Marketing Department of Oxford University Press since November 2004. Their customer service has been consistently efficient, methodical and supportive. I would have no hesitation in recommending them to any future client” – Loui Allen OUP.

SPRING 2015

GOVERNMENT MAKING IT EASIER FOR SMALL AND MEDIUM SIZED BUSINESSES TO WIN PUBLIC SECTOR CONTRACTS The public sector spends £187 billion each year on goods and services, and the Government wants to work with more small and medium sized businesses (SMEs).

We know SMEs offer value for money and services just as good as big companies, so we want to make sure you can successfully compete for our business.

That’s why we’ve changed the way government buys goods and services, to make the process easier for everyone.

So what’s changed?

• All public sector contracts will be advertised in one place - 'Contracts Finder', this includes pipelines, not just existing contracts

• We’re breaking down big contracts into smaller ones, making it easier for SMEs to bid for them

• We’re removing complicated questionnaires and forms

• You will get paid within 30 days - through the entire supply chain.

Interested? Watch Piers Linney’s (BBC Dragon’s Den) tips on winning public sector contracts here.

Don’t delay!

Find out more at: GOV.UK - A guide to doing business with government - click here.

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MEDILINK PROFESSIONAL DEVELOPMENT

EVENT LISTINGMPD INCORPORATING HUMAN FACTORS IN YOUR MEDTECH DESIGN PROCESS26 March 2015Medical Technologies Innovation Centre, Edgbaston9.30am - 16.00pm

Do you need to deliver your project faster, with lower development costs and less risk?

Take away a toolkit that will enable you to understand your product's target user group(s), identify and mitigate risks effectively, make data based decisions, increase user satisfaction and improve the product by incorporating robust market advantage features into its design.

Book Now

MPD EXPLORING THE PATENT BOX AND EXPLOITING YOUR IP RIGHTS15 April 2015Medical Technologies Innovation Centre, Edgbaston9.30am - 12.30pm

Using patents to protect your medical device can be a costly business, but can you afford not to?

This half day Medilink Professional Development (MPD) event will explore the importance of exploiting your Intellectual Property (IP) rights and how you caneffectively reduce the costs of protecting your business

with the Patent Box scheme.

Book Now

MPD AN INTRODUCTION TO EU MEDICAL DEVICES REGULATORY AFFAIRS23 April 2015Medical Technologies Innovation Centre, Edgbaston 9.00am - 16.30pm

Do you have the knowledge you need of theregulatory requirements for medical devices in the EU?

This course is for those with little or no background or knowledge in the main medical device directives. This will help you to gain an understanding of theregulatory requirements for medical devices in the European Union (EU).

Book Now

SPRING 2015

SHORTLIST ANNOUNCEDCompanies from across the UK have been announced as part of the shortlist for the

prestigious Medilink UK Awards 2015 - celebrating cutting edge technologies, outstanding business achievements and international success across the UK’s Life Sciences sector.

The Medilink UK Awards, a nationwide competition spanning over 1,500 Life Sciences companies will celebrate its winners at a Gala Dinner in April, alongside the UK’s largest Medical Device industry event - the Med-Tech Innovation Expo 2015.

The esteemed awards ceremony, will take place on 29 April in the E.ON Lounge at the Ricoh Arena, Coventry.

Companies have been shortlisted by judges in every region of the UK. The entries are made up from the best of the regional Medilink Award winners and categories for this year’s awards include: Start-Up, Innovation, Partnership with the NHS, Export Achievement and Outstanding Achievement.

Examples of excellence include: West Yorkshire-based V-Connect also stand out for the service they developed which offers a secure, simple way for care organisations to interact with people at home using video communication.

West Midlands-based Genesis Automation Ltd who, in a collaboration with the NHS and some of its major suppliers, created Genesis an Inventory and Cost Management System that is able to provide hospitals with instant data on costs for all procedures in real-time, enabling the hospital to produce better patient outcomes and control costs more efficiently.

Follow the conversation on Twitter using #MLUKAwards15 or for wider Expo news follow #mtiexpo.

Start-Up Award CYP Design Limited - Medilink East Midlands Jellagen Pty Limited - MediWales Perfectus Biomed - Medilink North West The Diabetic Boot Company Ltd - SEHTA Aston EyeTech Ltd - Medilink West Midlands Swellaway Ltd - Medilink Yorkshire & Humber Taragenyx - Life Sciences Scotland

Innovation Award Snowden Healthcare - Medilink East Midlands Tactical Wireless - Life Sciences Scotland Asalus - MediWales Global Diagnostics - Medilink North West The Learning Clinic - SEHTA Kimal PLC - Medilink West Midlands Brandon Medical - Medilink Y&H

Partnership with the NHS Award B&V Group - Medilink East Midlands Microvisk - MediWales Veraz - Medilink North West Dolby Vivisol - SEHTA Genesis Automation Ltd - Medilink West Midlands V-Connect - Medilink Yorkshire & Humber

Export Achievement Award Advancis Medical - Medilink East MidlandsDTR Medical - MediWalesVernacare - Medilink North WestDeltex Medical - SEHTANatural Wellbeing (Nutra Health) - Medilink WMPrinciple Healthcare - Medilink Yorkshire & Humber

Outstanding Achievement AwardInternational Laboratory Services Ltd - Medilink EMSharp Clinical Services - MediWalesMast Group Limited - Medilink North WestNovarix Limited - SEHTAPhysiological Measurements - Medilink West MidlandsGBUK Limited - Medilink Yorkshire & Humber

Medilink WM would like to take this final opportunity to wish all our Regional Winners the very best of luck in the MedilinkUK Awards 2015.

SPRING 2015

NEW MEMBERS

Evolyst Ltdhttp://www.evolyst.com/Evolyst specialises in the development of evidence-based projects that utilise digital technology, primarily in the Education and Healthcare Sectors. The company uses expertise in graphic design, UI design and illustration to create clean, modern looking products and brands; technical expertise to create robust and scalable products; a research background in behavioural psychology, in particular user-centered design and User Experience (UX) design to create products that people will want to use; and a strong management background that allows Evolyst to drive uptake of the product.

MasterControl Global Ltdhttp://www.mastercontrol.com/Within the regulated industries, MasterControl is known as a leading provider of quality and compliance software that enables highly regulated companies to accelerate compliance and get to market faster, while reducing costs and improving efficiency. To the hundreds of life sciences, manufacturing, and service-oriented companies worldwide that use MasterControl every day, we’re much more. To them, we’re a team of committed quality, regulatory, and IT professionals, working tirelessly to address all of their compliance and business needs. With product development driven by experts with years of experience working in the industries we serve, our enterprise quality management system (eQMS) solutions offer real-world value and competitive advantages.

Sweet Marketinghttp://sweet.marketing/Sweet is a marketing communications agency built on more than 40 years of experience across FMCG, B2B, B2C and technical accounts, perfected on brands like BSI, Chemist Direct, The Environment Agency, Land Rover, Holland & Barrett, Next Directory, Severn Trent Water, The SMMT and Wedgwood. We have fun crafting your solutions - but we’re constantly mindful of the serious need to optimise your ROI, and our particular role in optimising your MROI. Sweet people include marketing strategists, creative teams, digital specialists, marketing automation experts, PR practitioners and more.

GBUK Ltd has welcomed a new non-executive director to its board as the company continues its expansion in the UK and internationally.

John Adcock has been appointed with effect from February 2015.

John, a member of the European Authorised RepresentativesAssociation, is a medical device regulatory specialist and quality engineer with international productdevelopment, manufacturing and marketingexperience. He is also certified as a Lead Auditor for the Medical Device and Healthcare Industry and also certified with Health Canada to CMDCAS requirements (EN ISO 13485).

Medilink WM member John Adcock is ManagingDirector of Warwick-based Advena Ltd, a medicaldevice consultancy business, which specialises in working with small to medium size companies to set up ISO 13485 quality systems and to assist with the regulatory approval of medical devices.

Mark Thompson, Managing Director at GBUK Ltd, said: “We are very pleased that John is joining the GBUK Board. He has over 30 years’ experience in global medical device regulatory affairs, which will be a great asset to the Board as we continue this exciting period of growth.”

Reacting to his appointment, John Adcock said: “I am excited to join the Board of Directors of this market leader. I look forward to adding my regulatory and quality management expertise and advice to this profi-cient and talented team.”

To find out more about Advena Ltd visit their website click here.

JOHN ADCOCK OF WARWICK-BASED ADVENA LTD APPOINTED TO GBUK BOARD

SPRING 2015

The company was established with the directive of working with researchers, consultants and entrepreneurs, who have ideas for evidence-based projects that utilise digital technology, but lack the technical expertise to take them forward. Evolyst uses its unique skillset to research, design and implement the products or services using technologies such as software, sensors, apps or websites, ready for them to be taken to market.

The unique skillsets within the team at Evolyst fall into four main categories:

1. A research background in behavioural psychology, including user-centred design and User Experience (UX) design, allowing the creation of products that people will want to use;

2. Expertise in graphic design, user interface (UI) design and illustration to create clean, modern looking products and brands;

3. Technical expertise to create robust and scalable products;

4. A strong marketing and management background to drive uptake of the product.

Evolyst is a recent start-up, but already has an enviable record of international clients and projects. This includes a suite of education software for an established west midlands based educational psychology consultancy that operates internationally; the online portal for the West Midlands Health Informatics network based at the Institute of Digital Healthcare, University of Warwick; and software for a Multi-National financial institution based in Thailand.

You can gain access to quick and easy information about Evolyst and their projects by visiting their brand new website, developed by their in-house design and development team at www.evolyst.com.

INTRODUCING NEW MEDILINK MEMBER

EVOLYST

Evolyst Ltd is a highly skilled company that specialises in transforming evidence based ideas into digital products or services.

Backed by the University of Warwick Ignite Program, Evolyst is based at the Warwick Innovation Centre, part of the University Science and Technology Park.

SPRING 2015

Take advantage of the business benefits provided by new fibre optic superfast broadband infrastructure being rolled out with the Optimising Business Broadband Project.

The Optimising Business Broadband project has been created to help small businesses in Shropshire and Staffordshire to take advantage of the business benefits provided by new fibre optic superfast broadband infrastructure being rolled out in Shropshire and Staffordshire.

The Optimising Business Broadband project is designed for Shropshire and Staffordshire's small business community and will be delivering a FREE programme of events, workshops and one-to-one support and advice until June 2015.

The Optimising Business Broadband events will allow you to discover how your business can benefit from adopting fibre-based broadband. Learn how, by embracing digital technologies, you can increase your business’s competitiveness and performance by opening up new markets and creating more efficient ways of working.

Discover more about the free local and keynote speaker events being rolled out across Shropshire and Staffordshire until June 2015 – click here.

11th March – Getting social in Shropshire – Spring Event, Shrewsbury - This is a get together for anyone interested in social media in Shropshire.

22nd April – Business Resilience via Cloud Technology, Newcastle-under-Lyme - With fibre broadband spreading across Staffordshire it’s a great time to review how this can help support your business resilience planning.

We have a library of useful downloadable guides to help you benefit from technology. To access the downloads please click on the topic of interest, and you will be re-directed to our partner site. Once you have completed the online registration you will be able to access, and download your chosen learning tool.

By registering you also be eligible for a free prize draw to win a Samsung Galaxy Pro 8.4-inch Tablet!

Click here to view library.

IS YOUR BUSINESS BASED IN SHROPSHIRE OR STAFFORDSHIRE?

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MEDILINK PROFESSIONAL DEVELOPMENT

EVENT LISTING

Medilink Professional Development (MPD) in association with the Science Industry Partnership (SIP) is able to offer eligible SME’s in England a 50% grants towards upcoming training costs.

For more information contact Rebecca Ridley, Skills Project Leader, 0121 452 5630.RebeccaR@MedilinkWM.co.uk

MPD TIME TO TENDER: DEVELOPING A SUCCESSFUL BIDDING PROCESS IN THE MEDTECH SECTOR06 May 2015Medical Technologies Innovation Centre, Edgbaston9.30am - 16.00pm

Do you have the right knowledge and skills to make sure you are “fit to bid”, with a process that works for you?

This course will provide you with the knowledge and skills to help you build an effective bidding plan and gain a thorough understanding of the tender process gaining a sound understanding of the key drivers of creating and submitting successful bids.

Book Now

MPD WHAT’S NEW? CHANGES IN INTERNATIONAL TRADE PROCEDURES13 May 2015Medical Technologies Innovation Centre, Edgbaston9.30am - 16.30pm

Are you running the risk of being left behind performing tasks or paying charges that are no longer required due to changes in International Trade Regs?

Attending this event will ensure you are fully aware of key changes and new regulations that have come into force during the last 12 months so you can check your current processes and procedures to ensure you are up to date and compliant.

Book Now

SPRING 2015

KNOWLEDGE TRANSFER SHOWCASE EVENT 2015: NETWORKING AND EXHIBITIONWednesday 25th March 5:00 - 7:00 pm, Great Hall, Aston University

You are invited to join Medilink member Aston University for a celebration of Aston's Knowledge Transfer projects including Knowledge Transfer Partnerships (KTP), Knowledge Enterprise Exchange Networks (KEEN) and Innovate UK sponsored Collaborative R & D projects.

The event is an opportunity to discover more about the exciting and innovative projects that Aston is currently involved with and how we are working in partnership with local and national companies.

Aston has many successful collaborative projects in a variety of subject areas including product design and development, photonics, optometry, operations and information management and many more.

The teams working on these exciting projects have prepared posters detailing their projects for entry into a competition. Prizes for winning posters will be awarded by Aston’s Vice-Chancellor, Professor Dame Julia King.

Come and find out about our exciting collaborative projects. Refreshments will be provided throughout the evening.

To register with Eventbrite click here.

For further information: Business Development Team, ktp@aston.ac.uk or 0121 204 3396.

Neelam Patel wins first prize in the 2014 established project category for her work with BBR Optometry and Aston academics

Raquel Gil Cazorla wins first prize in the 2014 early stage project category for her work with Eye Docs and Aston academics.

THE BIOHUB BIRMINGHAM TO SPONSOR MEDILINK UK OUTSTANDING ACHIEVEMENT AWARD The Medilink UK Awards celebrate cutting edge technologies, outstanding business achievements and international success across the UK’s Life Sciences sector.

Medilink West Midlands member The BioHub Birmingham is proudly sponsoring the Medilink UK Outstanding Achievement Award, presented to companies whose achievements have had a significant or vital impact on the company and the sector as a whole at the Medilink UK 2015 Awards.

The esteemed Medilink UK Awards Ceremony will be held alongside the UK’s largest Medical Device industry event the Med-Tech Innovation Expo 2015. The Awards Gala Dinner will be held on 29 April in the E.ON Lounge at the Ricoh Arena, Coventry.

The shortlisted companies for the Outstanding Achievement Award, Sponsored by The BioHub, Birmingham are:

International Laboratory Services Limited - Medilink East MidlandsSharp Clinical Services - MediWalesMast Group Limited - Medilink North WestNovarix Limited - SEHTAPhysiological Measurements Limited - Medilink West MidlandsGBUK Limited - Medilink Yorkshire & Humber

To see all of the shortlisted companies click here.

Follow the conversation on Twitter using #MLUKAwards15 or for wider Expo news follow #mtiexpo.

SPRING 2015

DIGITAL HEALTH AND CARE CONGRESS 16-17 June 2015The King’s Fund, London W1G 0ANThe King’s Fund’s Digital Health and Care Congress is a two-day conference and exhibition that explores how the innovative use of information and technology is enabling patient-centred care.

The event is a showcase for exciting new digital health innovations, technology, research, and service delivery methods that are having a positive impact on care providers and service users.

Let our speakers inspire youAll of the digital health and social care projects that will be featured at the congress have been through an extensive, peer-reviewed submission process. Let these innovative approaches to care delivery inspire and motivate you.

See new digital health technologyCheck out some of the new digital health applications and wearable devices you may have heard about in the exhibition hall, innovation hub, and health care app showcase area.

Discuss and network with your peersMix and mingle with more than 500 fellow attendees from the NHS, local government, academic institutions, third sector, commercial providers, digital health start-ups, entrepreneurs and innovators.

Hear from those leading the digital health agendaThe agenda features expert patients like Dave deBronkart (better known as e-Patient Dave) and those with responsibility for leading this agenda in the NHS:

• Tim Kelsey, National Director for Patients and Information, NHS England• Beverley Bryant, Director of Strategic Systems and Technology, NHS England• Paul Rice, Head of Technology Strategy, NHS England.

Find out more - click here.

Medilink UK, is pleased to announce that as part of the Science Industry Partnership (SIP), a skills programme for the Med Tech Sector, we are able to offer eligible companies a 50% grant towards the cost of the ticket price for the Digital Health and Care Congress. To find out more information and to check your eligibility please contact Rebecca at skills@medilinkwm.co.uk or call on 0121 452 5630.

WELCOME TO NEW MEMBERS

POLYFLON TECHNOLOGY LTDMedilink welcomes new members Polyflon Technology Ltd. Polyflon Technology was set up as a family enterprise 25 years ago with initial manufacturing activity being the extrusion of PTFE tubing.

The company quickly diversified by adding new materials to its extrusion programme and now manufacturing capabilities include thermoforming, machining, fabrication and various types of moulding operations.

Fluoroplastics are an essential component in almost all present day hi-tech industries. Whether your field is medical, biotechnology, pharmaceutical, microelectronics, high purity fine chemicals, environmental monitoring, oil & gas or pilot plant research, fluoropolymers processed by Polyflon play a vital role.

Dedicated to providing a personalised approach to their customer requirements, the company continues to grow and innovate with the addition of a new cleanroom, new purpose built premises and the expansion of their team.

If you would like to find out more about Polyflon Technology and their product range or if you would like to explore how Polyflon could assist you to deliver cost effective products of exceptional quality and reliability get in touch on01785 859054 or email info@polyflon.co.uk

SPRING 2015

DO YOU WANT TO RECEIVE A

50% FUNDING GRANT FOR YOUR WORKFORCE DEVELOPMENT COSTS?

Medilink Professional Development (MPD) in association with the Science Industry Partnership (SIP) is able to offer eligible SME’s in England a 50% grants towards upcoming training costs. Companies within the MedTech and Life Science sector can apply for a grant to provide workforce development activities that will ultimately drive business. So if you thought that essential skills course was out of your price range-think again.

MPD are hosting a variety of Master Classes across the West and East Midlands that are eligible for the 50% funding. These courses have been created with business development in mind and cover a wide range of topics, however if you feel there is an essential course that we aren’t currently offering that then let us know, we will do our best to accommodate your requests. To see our full events calendar click here.

Alternatively if you have sourced a training company that offers a course specific to your needs we can potentially offer a 50% grant for this too. The subjects range from leadership and management training to specialist training for new equipment and everything in-between. If you want to discuss your specific business development needs then contact your nearest Medilink office who will be happy to provide support and advice.

Contact Rebecca Ridley, Skills Project Leader, 0121 452 5630 / RebeccaR@MedilinkWM.co.uk

This project has been partly supported by HM Government with Employer Ownership funding.

SPRING 2015

EVENTS LISTING

SKILLS SOLUTIONS FOR SCIENCE INDUSTRY EMPLOYERS 15th April 2015, 5.30pm - 7.30pm. UTC, Cambridge

Medimmune, a Science Industry Partnership (SIP) Board Member, will lead the first networking event in the Cambridgeshire area, for employers and stakeholders working in the science industries.

The evening will start with an overview of the SIP, introducing the full range of SIP Programmes, including;• The new SMART Apprenticeships - how these can work

for your company• Higher Education - innovative employer-provider

collaboration• Workforce Development & Training - access to 50%

reimbursement funding• Becoming a SIP Ambassador - inspiring the next

generation into STEM-based careers

Take advantage of this excellent opportunity to network with employers already accessing funding and skills solutions through the SIP, as well as training providers in your local area and other stakeholders involved in supporting and delivering the SIP across the region.

The event is free and open to all employers in the science industry sector, regardless of size including SMEs and supply chain companies. Our experts will be on hand, to discuss how you can access funding and flexible skills solutions to meet your requirements. Register Here

For further information please contact the Cogent Events Desk. T. 01925 515220. E. kate.hutchins@cogentskills.com

SMARTEN UP WITH WEARABLE TECH01 April 2015, 4 More London17.30pm - 19.00pm

The future is wearable, but what form it will take is still a work in progress. Join Wragge & Co at their 4 More London office on 1 April 2015 for an evening all about wearable technology.

Book Now

ASTHMA & COPD13 April 2015, London

SMi's 11th annual Asthma & COPD conference will share in the experiences of leading lights in the field who are addressing the challenges of solving the riddle of pathogenesis, biomarkers and endpoints, personalising therapies vs. the unmet need, tackling the causes and consequences of exacerbations, development of new animal models and better tools for disease diagnosis and monitoring.

Book Now

NAIDEX NATIONAL 201528 April 2015NEC Birmingham

Naidex is the UK's largest disability, rehabilitation and homecare event with over 300 exhibitors featuring the latest products and services to aid independent living. The show brings together healthcare professionals, members of the public, retailers, buyers and dealers.

Book Now

DIGITAL HEALTH AND CARE CONGRESS16 June 2015The King’s Fund, London

The King’s Fund’s Digital Health and Care Congress is a two-day conference and exhibition that explores how the innovative use of information and technology is enabling patient-centred care. The event is a showcase for exciting new digital health innovations, technology, research, and service delivery methods that are having a positive impact on care providers and service users.

Book Now

SPRING 2015

THE APPLE EXPECTATION Neil Oliver, Technical Marketing Manager at Accutronics, explores the use of portable medical devices in home healthcare and patient's expectations.

Think of a medical device and you'll immediately think of a large, AC mains-powered machinelike a ventilator or medical imaging equipment such as an MRI, PET or CT scanner.However, dig a little deeper and you'll realise you're probably carrying one in your pocket.A typical smartphone now carries the computing power historically limited to processintensive industries such as space exploration missions.

It is this ambiguity which is blurring the line between a consumer electronic device, such as a smartphone or smartwatch, and a fully fledged professional medical device. Designed for portable use to monitor, diagnose and inform long term treatment plans, the functions performed by professional medical devices, such as pulse oximetry, blood pressure monitoring, kidney diagnosis and glucose meters, have opened the market to consumer manufacturers and third-party app developers, putting patient health at risk.

Design traits typical of consumer devices are defining the normally expected characteristicsof portable medical devices. As consumers we have come to expect lightweight and thindevices with often embedded batteries that last up to 12 hours and products that arereplaced with new versions every 12 months.

Because product development lifecycles (PDLCs) for medical devices are typically longer, around ten years, removable rather than embedded batteries are the norm. This allows backup batteries to be used in the field, effectively extending battery life on the fly as well as meaning that users can easily replace batteries at the end of their life. It's normal for Lithium-ion (Li-ion)batteries to provide 300-500 charge cycles before the battery life drops to an unacceptable level. Excessively reducing weight and thickness for aesthetic purposes can also have a knock on impact on battery life and quality. Less space means the battery's volumetric and gravimetric density will be limited, affecting its total lifespan.

Home healthcare. The innovation in portable and wearable devices has largely been the result of an ageing population all over the world leading to the rise in age-related, long term health conditions. The most common chronic conditions are high blood pressure, Alzheimer's, heart disease, depression, arthritis, osteoporosis, diabetes, cancer and stroke. It's no surprise then that this trend is proving challenging for an already over burdened hospital and inpatient infrastructure.

Research by the U.S. Food and Drug Administration (FDA) has shown that, "As patients move to the use of home health careservices for recuperation or long-term care, the medical devices necessary for their care have followed them. In fact,according to results of the 2000 National Home and Hospice Care Survey approximately 1,355,300 patients were receiving home health care services from 7,200 agencies." However, the medical devices designed for use in hospitals by trained professionals were never intended for use by patients in the home. As a result, many patients, especially those who do not have the regularassistance of a dedicated home healthcare professional, struggle to operate, understand, maintain and troubleshoot devices. This has spurred third-party manufacturers to cater for patients looking to fill the void with pseudo-medical devices that feature familiar ergonomics and heuristics.

Industry Collaboration. Being part of a company that has over 40 years' experience in the design, development and manufacture of batteries for medical devices, I've seen my fair share of trends come and go over the years. To embrace this latest innovation in wearable and portable devices used predominantly in a home healthcare environment, Accutronics' innovation philosophyembodies an ethos of a holistic product development process. Although it's important to take a holistic approach whendesigning batteries for hospital based medical devices, it's absolutely vital when designing portable products for use in home healthcare. The smaller size and lower mechanical tolerances mean that if battery design is left as an afterthought, as it so often is, it could lead to the commercial failure of the product.

At Accutronics we advocate a widespread industry collaboration between numerous stakeholders, including design engineers, manufacturers, healthcare professionals and healthcare organisations as well as regulatory and accreditation bodies.Reducing the fragmentation so prevalent in the industry currently, will create a culture of sustainable product development, one that's required to face the challenges posed by the paradigm shift towards home healthcare.

Our range of credit-card batteries have been designed to overcome these problems by incorporating a powerful Lithium-ion battery with smart protection circuits that prevent overcharging, over discharging and overheating, all packaged in a credit-card sized unit. As well as this, algorithmic software security prevents fake batteries being used in these health-sensitive portable and handheld devices.

The yellow card system used by the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) is used in the medical industry to allow patients to report the adverse effects of medicines and incidents occurring from the use of medical devices. Raising awareness of methods like these will ensure that the right feedback is given to manufacturers to improve their products, undergoing any clinical testing where necessary.

So, as companies like Samsung and Apple enter into the wearable medical space, a concerted effort by all stakeholders will ensure that commercial short-termism can be turned into sustainable long term improvements in our health and, moreimportantly, in our quality of life.

Find out more about Medilink member Accutronics - click here.

SPRING 2015

Designers of innovative new products for the community healthcare sector have been urged to apply for a European funding stream before the programme deadline expires.

Coventry University Health Design & Technology Institute (HDTI) is dedicated to helping entrepreneurs, inventors and SMEs develop their ideas.

Support is available in the form of product design, from early concept through to prototyping and manufacture, and Medilink member HDTI also offers usability research to provide inventors with an independent evaluation of their idea.

The funding from the Assistive Technologies and Community Healthcare Development Project from the European Regional Development Fund (ERDF) covers Shropshire, Staffordshire, Herefordshire, Worcestershire, Warwickshire and the West Midlands, and comes to an end on December 31 this year.

Over 50 businesses across the region have already been assisted by the scheme over the last three years.

However, to ensure there is enough time to qualify for five days of free consultancy support, applicants should move swiftly.

Guy Smallman, commercial development director at HDTI, said the ERDF funding had already helped a wide variety of entrepreneurs, inventors and SMEs turn their ideas into reality.

“As the ageing population continues to grow, there is an increasing need for healthcare products that help older people and those with disabilities to live more independent, comfortable, enjoyable and productive lives. There is an increased focus on providing products which can improve our wellbeing,” he said.

“We have a specialist design team at HDTI who can play a part in transforming an idea from an initial concept into a prototype or finished product. This, in turn, can be evaluated in a usability study we put together.

“It is critically important to gain constructive feedback from potential users who are completely independent and impartial, instead of carrying out market research with friends and family. Relatives and close associates will rarely give completely honest advice and relying on them to be objective is very risky.

“An academically led usability study feeds back into the design process and can be used extremely effectively to support a company’s marketing activity, find a commercial partner or attract additional investment.

“We can also assist in the area of intellectual property and perhaps help in finding a manufacturer.

“The ERDF scheme is here to help SMEs in the West Midlands to take the next step but the funding requirements mean we need to hear from interested applicants as soon as possible to put all the necessary steps in place before the end of this year.

“This kind of free funding is becoming increasingly difficult to secure and we don’t want anyone to miss out.”

For further information contact Guy Smallman at guy.smallman@coventry.ac.uk or visit www.coventry.ac.uk/hdti

WEST MIDLANDS ENTREPRENEURS, INVENTORS AND SMES TURN THEIR IDEAS INTO REALITY WITH EUROPEAN FUNDING

Guy Smallman, Commercial Development Director, HDTI

SPRING 2015

The WMAHSN invites you to attend their Annual Stakeholder Event, which takes place at Cranmore Park in Solihull on Tuesday 28 April 2015.

Featuring breakout discussions on the West Midlands’ health and wealth challenges for the forthcoming year and workshops examining the future for different stakeholders, this free to attend event will inform delegates on the impact that the WMAHSN has made on the local healthcare sector and help to shape its priorities for the year ahead.

For more information, please take a look at the agenda.

The WMAHSN Annual Stakeholder Event is aimed at representatives from the following sectors:

• NHS organisations• Academia• Patients, carers and the public• Industry• The third sector.

To confirm your attendance at the WMAHSN Annual Stakeholder Event, please register at Eventbrite.

WMAHSN have attractive and excellent value for money sponsorship and exhibitor packages available for this event. To discuss the features and benefits of sponsorship and exhibiting, please contact Sarah Millard on 0121 452 5636 or email sarah.millard@wmahsn.org.

WMAHSN INVITE YOU TO JOIN THEM AT THEIR ANNUAL STAKEHOLDER EVENT

SPRING 2015

ALERT: IMPERSONATION OF MHRA STAFF

AGENDA ANNOUNCED FOR WIRED HEALTHWIRED is delighted to announce the agenda, subject to updates, forWIRED HEALTH, the forthcoming one-day-summit taking place on Friday, 24 April, Royal College of General Practitioners.

Designed to introduce, explain and predict the coming trends facing the medicaland personal health industries, WIRED HEALTH will once again gather insight fromscientists, entrepreneurs and thought leaders crafting the future of health, and offer a tight focus on this sector. Individual session themes and speakers within each session include:

CONSUMERISING THE MEDICAL DEVICE - Clive G Brown, CTO, Oxford Nanopore Technologies. Matteo Lai, cofounder and CEO of Empatica Inc.EXTENDING LIFE - Brad Perkins, chief medical officer, Human Longevity Inc. AUGMENTING THE HUMAN - Nigel Ackland will speak about the experiences of living with a bionic prosthetic; Sophie de Oliveira Barata, founder of The Alternative Limb Project.SINGULARITY UNIVERSITY/ EXPONENTIAL MEDICINE - High-altitude medic Jack Kreindler; Martin Kohn, chief medical scientist, Sentrian.HUMANISING THE INTERFACE - Gadi Amit, founder of NewDealDesign. Lama Nachman, principal engineer, Intel Labs.HACKING BEHAVIOUR - Marc Koska, British inventor of K1 auto-disable syringe; Jen Hyatt, CEO of Big White Wall. Rory Sutherland, vice chairman, Ogilvy Group UK.A NANOSCALE APPROACH TO CANCER - Sonia Trigueros, co-director, Oxford Martin Programme.DECODING THE BRAIN - Sarah-Jayne Blakemore, professor of cognitive neuroscience, UCL. Eleanor A Maguire, professor of cognitive neuroscience, UCL. John F Cryan, neuroscientist. Adam Gazzaley, professor of neurology, physiology and psychiatry, University of California.OPTIMISING PERFORMANCE - Andy Walshe, director of high performance, Red Bull. Geoff McGrath, vice president, McLaren Applied Technologies.

Speakers on the Bupa Startup Stage will be announced in due course. The Bupa Startup Stage will bring together both emerging and established entrepreneurs from the world of medicine and health, all charged with presenting brand new ideas, instigating change, stimulating debate and showcasing what they perceive the future to be.

WIRED HEALTH will bring together the most talented people, forward-thinking innovators and captivating thought leaders, both on stage and off. Aimed at a high-level executive audience, attendees will enjoy the opportunity to network with like-minded, intellectually curious individuals from the sector including physicians, senior healthcare executives, innovators and investors.

There are a limited number of tickets available for WIRED HEALTH, at a price of £995. For further information, to see the full agenda topics or for registration, go to www.wired.co.uk/health15.

Medilink SIP Grant Funding fee: £497.50* eligible SMEs can reclaim 50% of the standard delegate fee. Please contact Bev@MedilinkEM.com for further information. Medilink members who are not eligible for SIP grant funding can receive a 10% discount using code: WHMEDLINK10

*Eligibility – Under the Science Industry Partnership (SIP) scheme, eligible companies must be located in England and have less than 200 employees.(This project has been partly supported by HM Government with Employer Ownership funding.)

In February MHRA published an article informing businesses they are aware of telephone calls made to a company recently from an individual who does not work for the agency claiming to be a member of MHRA staff.

They know that companies are generally alert to this type of activity but ask you to please remind your staff to be vigilant.

If you do not recognise the name of the caller, please do not hesitate to take their number and contact our Customer Services team on 020 3080 6000 to check whether the caller is genuine before you give them any information.

News story published by MHRA - to visit the web-page click here.

SPRING 2015

REDESIGNING HEALTH & SOCIAL CARE:

CHALLENGES & OPPORTUNITIES FROM AN IT & DIGITAL PERSPECTIVE REPORT Medilink WM member Boilerhouse were commissioned by ADASS (Association of Directors of Adult Social Services) and Soctim (Society of Information Technology Management) to conceive, write and design a high-level, illustrated guide to recent and forthcoming reforms, including the Health and Social Care Act 2012 and the Care Act 2014 that sets out some of the consequences, especially for IT and digital policy and activity.

'Redesigning health and social care: challenges and opportunities from an IT and digital perspective' is a 22 page document written for senior policy and decision-makers across these and related sectors. The summary applies specifically to England in terms of the new legislation and policies, although the underlying issues relate to the whole of the UK.

Socitm is playing a key role in the Care and Support Reform Programme by helping local authorities and other stakeholders prepare to deliver the information management and underpinning technology changes required.

Councils face significant challenges as they ready themselves for these reforms. Case record management systems will need to embrace the more personalised approach in which citizens take greater responsibility for their own care, including those using the full spectrum of voluntary, private and public sector care services.

Councils will be required to provide better social services and health care information online. They will also have to consider the data security and privacy implications of using the Public Services Network (PSN) as the basis for greater local authority sharing of health and care information between different providers of care. Each council with a social care remit will be responsible for implementing these changes in collaboration with their service users, partner organisations and ICT suppliers.

To download a copy of this high-level guide to information and technology challenges and opportunities in a rapidly changing landscape – click here.

SPONSORSHIP OPPORTUNITIES FOR MEDILINK UK AWARDS Do you want to rapidly raise your profile with one of the UK'shigh value growth sectors?The Medilink UK Awards 2015 is a nationwide competition spanning over 1,500 organisations from across England, Ireland, Wales and Scotland – and now you can receive nationalexposure alongside this world-leading event through a number of high-profile sponsorship opportunities.

This year the Awards Evening (29 April 2015) is a core part of the Med-Tech Innovation Expo, the biggest dedicated medical device manufacturing trade show in the UK. The Awards will be hosted on the first evening of the Med-Tech Innovation Expo alongside a Gala Dinner within the E.ON Lounge of the Ricoh Arena to over 200 leading and influential healthcare technology sector companies and representatives.

Sponsorship of the Medilink UK Awards is highly sought after, so if you want to rapidly raise your profile with the Healthcare Technology and Life Sciences Sector, contact us for more information - click here.

Click here to view

sponsorship opportunities

SPRING 2015

Technology was at the forefront of the news agenda during 2014; from IT failures grounding UK flights to hackers accessing private images of A-list celebrities. Businesses must learn from these mistakes to ensure they are in a stronger position this time next year. This can only be achieved through the continued quest for innovation throughout 2015 and in this article John Cooke, a founder and Managing Director of Black Pepper Software, explores the developments in technology and software we can expect to see this year and how these will impact UK businesses.

Technology stargazing - The exponential growth of cloud services such as DropBox highlights business technology continued moving into the mainstream in 2014. Despite hitting Gartner’s ‘trough of disillusionment’, cloud computing is now a huge part of professional and consumer life. Although it’s unclear which technology will lead the way over the next twelve months, John believes these areas will move further into the mainstream in 2015.

Internet of Things (IoT) – While a wide variety of technology businesses have taken advantage of the IoT’s benefits, 2015 will see far more progression and innovation in this area. The automation facilitated by the IoT enables businesses to work smarter, freeing IT managers to focus on business critical actions. I believe the IoT will be used across more industries, in a machine to machine capacity (m2m), where devices communicate with remote applications in order to monitor and control the devices themselves. Businesses that continue to ignore the IoT will find themselves floundering behind their competitors.

Cloud adoption – Research shows 53 per cent of UK businesses consciously use cloud services and this will continue to grow throughout 2015. As cloud adoption increases, the IT industry will shift simultaneously. Gartner predicts that by 2020 at least 70 per cent of new app development projects will be deployed to either private or public cloud infrastructures. Failing to adopt now isn’t an option – it’s not if, but when.

2015: A software odyssey - Once the decision has been made to move into the cloud or introduce new systems that utilise the IoT, businesses should make sure their software provider is up to speed in these crucial areas: Security – Security issues have continued to dominate the technology news agenda throughout 2014; from the iCloud debacle to the recent Amazon hack. If this taught IT departments anything, it’s the importance of ensuring security standards are at their highest.

Fast delivery – With rapid technology progress comes increased demand and it’s vital development teams deliver projects rapidly without jeopardising product quality. Agile software development allows teams to provide value and results to the customer within weeks rather than months.

Reshoring- Finally, I predict re-shoring will play a large role in the software development landscape this year, as many companies realise the problems that can occur with off-shoring.

How should businesses react to these forecast changes? Businesses must embrace the IoT and cloud technologies in order to remain competitive in 2015 and the coming years. In doing this, organisations need to ensure their software development partners are well versed and using methods that ensure high level security, innovative approaches and fast turnaround of projects.

Agile approaches embrace innovation, rapid delivery and excellent communication, and the time has come for wider businesses to embrace this model. Utilising wholesale agile methods may not suit every organisation, but there will always be aspects which can increase business efficiency.

Many start-up businesses have already adopted an agile approach to business and are reaping the rewards, but I predict 2015 will be the year many more large enterprises take advantage of the vast benefits of running a truly agile organisation.

To read the article and find out more from John Cooke – click here.

DEVELOPMENTS IN TECHNOLOGY & SOFTWARE 2015Medilink member Black Pepper Software’s Managing Director John Cooke explores the developments in technology and software we can expect to see this year.

SPRING 2015

THE POWER OF THE RECOVEREDThe development of a revolution in the treatment of anxiety disorders.

For over 17 years we have been helping anxious people to discover, or in somecases, re-discover their true selves and move on with anxiety free and fulfillinglives and have been asked numerous times by our recovered clients how they canhelp us to help others.

Medilink member The Linden Centre needed to come up with a no-compromise recovery Coaching solution and two years later, we are there. The Linden Method home learning programme, the apps, the Residential Anxiety Recovery Retreats and the corporate offerings all provided data from over 170,000 cases, that we have distilled into a game changing solution.

Linden Tree Education Limited is now an NCFE Accredited Educational Centre. The NCFE are the oldest awarding body in the world, with a flawless reputation for delivering high quality learning solutions.

We have developed the world’s first Anxiety Recovery Coaching Programme ‘LAR Coaching’ which has been accredited by NCFE at Level 4 .

There are two entry levels and two delivery formats.

The first is a three-day course which can be completed by current therapists who have pre-existing and relevant qualifications. Courses will run monthly from end of March 2015.

The second is for ex-suffers or indeed anyone wishing to provide curative coaching to sufferers. They will be able to complete a home study programme leading to the same accreditation (approx 110 hrs study time).

The application of this training means that anyone from school nurses, to those working in clinical practice, private or public healthcare, in educational organizations etc can be ready to assist those developing an anxiety condition.

Through tracking and reporting and regular gathering of trial data, we have evidence that our programmes reduced anxiety sufferers from GAD7 18.24 to GAD7 2.84 – from severe to normal. This evidence is echoed in the thousands of testimonials and medical, psychological and celebrity endorsements we receive.

We can now enable others to provide a truly curative programme with the backing of an organisation, support team and an unmatched reputation.

For more information, please contact Liz Cox on 01562 742004 or 07951 562239.

BOOK NOW FOR MEDILINK UK 2015 AWARDS DINNERThe Medilink UK Awards 2015 is a nationwide competition spanning over 1,500 companiesfrom across England, Wales, Scotland and Ireland, celebrating the achievements andsuccesses of companies from across the Healthcare Technology and Life Sciences industry.

The shortlisted companies and winners of the awards will be recognised at a Gala Dinnerin April as part of the UK's leading Healthcare Technology event - the 2015 Med-TechInnovation Expo.

Winners from each of the Medilink UK regions will be shortlisted for five awards. The UK Awards will take place on the even-ing of 29th April 2015 at the Ricoh Arena, Coventry. As well as providing sector leading networking and a leading showcase for UK Life Science businesses, the evening will include:

• Drinks reception. • Close work magician - Afro Magic. • 7 piece swing band - 'Swingamathing'. • 3 course dinner. • After dinner speaking from Winter Paralympian and World Cup Skier Sean Rose. • Medilink UK Awards Ceremony.

To book your place - click here.

SPRING 2015

It's not unusual to be thinking about how notified bodies and regulators will see your product development and where they may find holes. The closer you get to submission of your newly developed device or combination product, the larger this probably looms in your mind. You could easily spend days sifting through inspection trend information available online, without understanding what you should be doing now to avoid being part of the deficiencies statistics.

There are common themes across both drug and device audit deficiencies. The good news is that getting it right for one field will cover a lot of what's problematic in the other.

Common areas of deficiency include;1. Lack of SOPs in key areas. 2. Lack of evidence of following SOPs that are in place. 3. Inadequacy of testing for release of batches of drug product and devices. 4. Poor or non-existent, calibration and maintenance of laboratory and production equipment. 5. Process validation gaps or absence. 6. Investigation of failures being inadequate. 7. Either a lack of, or undocumented, training. 8. Incomplete records for batches produced, be they drug product or medical device. 9. Changes are often poorly proceduralised and documented.

You may be wondering how you can tackle these deficiencies, quickly and sustainably. There are five things to focus on, irrespective of whether you're working on a medical device, combination product or drug product:• Document what you do [“say what you do”]. • Ensure that you've routinely got evidence of following your procedures [“do what you say you'll do”]. • Make sure your incoming, IPC and release tests are appropriate to demonstrate you're meeting your specifications [“make sure what you are doing makes sense”]. • Be able to demonstrate, robustly, that your processes are validated and maintained in compliance with their validated scope of use [“keep doing what you say you'll do”]. • Use a process that helps you keep on top of changes, their impacts and ensures you document all that you need to demonstrate investigation [“document when you need to change from what you said you will do, and justify it”].

Actually, there's a sixth thing to focus on, but it spoilt the attraction of a 5 point list, and I like neatness in my lists!

There is increasingly greater scrutiny of purchasing controls, according to reports from organisations undergoing audits in the past several months. Be prepared, take an honest look at your controls for sub-contracting and outsourcing of activities or supply. Look at the basis for selection and the suitability of your supplier's quality management system for what they're supplying to you, or the activities they're performing on your behalf.

For all 6 points, it's a fine balancing act between over-documentation (jumping through self-imposed hoops, or creating unwarranted non-compliances) and failing to describe what you do sufficiently to follow it routinely. Experience of what can work well for your situation and knowing the right amount to put in place, can pay huge dividends and avoid you tying yourself in knots.

There is a pragmatic way to do this, a way that we've used with success for several clients in the last year, for medical devices and combination products.

As with many things in our industry, the FDA take the lead in describing the scope and content of their inspections for medical devices. In brief, the agency's QSIT approach describes four areas that investigators can cover during an inspection (they typically cover at least 2 of them); • Management & general points. • Design Controls. • Production & Process Controls. • Corrective and Preventive Actions (CAPA).

Now, we could have dived straight in to the published QSIT guide and tried to use it to assess their systems, documentation and development history. Instead we built upon a view shared by one of our associates, to; • Ask a series of questions in each of the four areas. • Find issues that investigators could uncover. • Describe the "ideal response". • Craft practical solutions to get closer to the "ideal response". • Support implementing these solutions.

Our work together was greatly appreciated, particularly the solutions to issues uncovered and helping put them in place as we went along; knowing when to stop digging for issues and when to move to filling in the holes. We ended up with a traceability matrix from auditors' expectations through to the solutions and evidence of compliance. Useful for the back-room during an audit too.

You'll appreciate that managing the issues, prioritising their resolution and tracking closure is no small task. You may be relieved to learn that we did it all in a straightforward spreadsheet, even using it to report KPIs to management. In the time available, we focused upon resolving the most critical issues, then those that were less likely to kill an inspection.

To find out more about Three Circles visit the website - click here.

CORRECT THESE 9 DEFICIENCIES TO AVOID BECOMING A REGULATORY INSPECTION ROAD-KILL Written by Matthew Theobald, Quality Factors Director, ThreeCircles Ltd

SPRING 2015

This FREE workshop will provide information about the practical steps an organisation can take to implement sustainable activity and improve performance and profitability and the support available to assist you. • UK BCSD – Introduction: Sustainable development : A Business framework• Cynnal Cymru – Sustainable Development Charter and policies.• Business Wales – Skills Agenda• Eco Studio – Presentation title TBC• Ecodesk - Sustainable Supply Chains – Principals and Practice• Wise – How Swansea University can support businesses with R&D• BSI – A guide to Managing the Sustainable Development of Organisations• Interactive session – measure your sustainability credentials

SHARE YOUROPINION ABOUT THE mHEALTH MARKETTAKE PART IN THE 2015 mHEALTH APP DEVELOPER ECONOMICS STUDY

The mHealth app industry has created a lot of hype recently. The number of mHealth apps has surpassed the 100,000 mark, big players like Apple and Samsung have announced new enabling platforms, sensor-integrating mHealth business models have caught a lot of press coverage and investors are lining up to push money into the market.

Still, the number of solutions that are integrated into the daily routines of healthcare professionals and that are reimbursed by payer organizations is limited. So what is the actual status of the mHealth industry and where will it be in 5 years? You can help to find out.

The 5th edition of the "Global mHealth App Developer Economics" study pays special attention to how mHealth apps make money, how they incentivise behavioural change and how they make use of APIs and sensors.

App developers, app publishers, healthcare professionals, national health authorities, healthcare companies and app market experts are invited to participate in the world’s largest study on mHealth apps development.

Take part in the largest mHealth App Developer Economics survey. The study should take approximately 20 minutes and you can share your experience and view on how the mHealth market will change the way healthcare is delivered.All answers are anonymized; contact details are requested in order to send you a copy of the report after its completion.

Participate and:• Get a free copy of the “Global mHealth App Developer Economics 2015 Report” once it is published. • See initial results immediately after completion of the survey. • Get insights into the current status of the mHealth app market.

For a chance to win one of the free entry tickets, you need to complete the survey until 26th April 2015.

To start the survey, please click here.

FREE EVENT PRACTICAL SUSTAINABILITY FOR BUSINESS

26th March 2015

The SURF Room, Fulton House, Swansea University

17:30-19:30 - Workshop19:30-20:30 - Buffet & Networking

FREE to attend. FREE Parking.

To register click here or email Victoria.Lambert@ukbcsd.org.uk

SPRING 2015

NATURAL WELLBEING LTDTO SHOWCASE AWARD-WINNING RANGE AT TWO INTERNATIONAL SHOWS 5-7 MAY 2015Vitamin, mineral and dietary food supplements company Natural Wellbeing continues to go from strength to strength, having enjoyed a very successful 2014.

Part of NutraHealth Plc, the UK’s largest supplier and manufacturer of VMS, Medilink member Natural Wellbeing benefits from a leading in-group UK tablet and capsule manufacturing facility which has full MHRA and cGMP accreditation. And with their clearly defined strategy to penetrate new international markets, growth looks set to continue through 2015.

Their innovative brand portfolio spans the entire demographic catering for mass and niche markets, with many unique formulations, and they are committed to developing high quality products at competitive prices. Their expertise in quality assurance, product development regulatory requirements and international product registration allows them to provide full support to customers as they launch brands into market. And that’s just the start of the supplier - customer relationship, with on-going support available in the form of nutritional education and expertise, product training and marketing support including in-country.

On the 5-7 May the company will be showcasing their range of award-winning products at two International Shows, VitaFoods Europe, the leading Nutraceutical event and Africa Health, the continent’s largest healthcare exhibition.

Why not take the opportunity to meet the Natural Wellbeing team at the shows below to discuss their wide range of high quality vitamins, minerals and dietary food supplements:

Vitafoods Europe5-7 May 2015 - Palexpo, Geneva, Switzerland

As the essential business event for professionals looking to source ingredients, raw materials and services dedicated to the global nutraceutical industry, Vitafoods Europe provides you with the opportunity to exceed your business goals in 2015. Attracting a focused audience of over 750 global suppliers and more than 14,000 senior manufacturers, distributors, researchers and scientists, no other event delivers such a targeted nutraceutical audience.

Meet the Natural Wellbeing team on Stand A18.

Africa Health 5 - 7 May 2015 - Gallagher Convention Centre, Midrand, Johannesburg, South Africa

Africa Health is the continent’s largest healthcare exhibition and is the leading platform for the industry to meet, learn and do business. The exhibition will attract more than 7000 healthcare professionals and host 500 of the world’s leading healthcare suppliers, manufacturers and service providers. Thousands of new healthcare products, equipment and services will be showcased by the main players inthe industry. Africa Health will provide an opportunity for you to seethe latest technologies on display and test them out all under one roof.

Meet the Natural Wellbeing team on the Medilink UK Pavilion Stand.

To find out more about Natural Wellbeing and their range of award-winning products – click here.

SPRING 2015

BE QUICK UK Pavilion Exhibitor Package for Africa Health 2015 can be found here. Please contact the International Team by Friday 20/3/15.

For more information on Africa Health or any of the exhibitions that Medilink participate in, please contact our international team on 0114 232 9292 or international@medilink.co.uk.

SPRING 2015

QUALITY IN DAY SURGERYA Joint British Association of Day Surgery and Healthcare Conferences UK Event - Thursday 26 November 2015 London

Following the success of our November event, we are delighted to announce the British Association of Day Surgery - Quality in Day Surgery Conference & Exhibition will take place in London on the 26th November.

Raise your profile and maximise your presence by sponsoring an NHS speaker and benefit from corporate branding throughout this conference.

Attending this conference will be Senior Clinicians including Clinical Directors and Managers of Day Surgery, Senior Consultant Surgeons & Anaesthetists, Theatre Managers and Nurses involved in improving the Day Surgery Pathway.

Reserve your stand now - download sponsorship information and booking form.

EARLY ANNOUCEMENT: SAVE THE DATE

Based at the heart of the long-standing Edgbaston Medical Quarter, the new BioHub Birmingham is a pioneering project that will provide much-needed laboratory facilities as a launch pad for medical innovation in the region. The team behind it have a vision of a core community of start-up and early-stage companies bringing their innovative medical developments to market all under the same laboratory roof.

Based on the ‘plug and play’ concept catching on fast in the US biotech sector, Medilink member The BioHub follows the model where the laboratory, equipment and office space are available immediately, at an affordable cost. The BioHub will be an interactive community of innovators sharing ideas and gaining inspiration from their contemporaries.

When James Wilkie, CEO of Birmingham Research Park, began his role in 2007 the tenant base at the Science Park was predominantly focused in the medical sector, but there were no early stage entrepreneurs in the mix. It became clear that start-up ventures needed to be attracted, and the route of providing a shared space facility seemed to be the logical solution.

After securing funding from the University of Birmingham, the European Regional Development Fund, and Birmingham City Council, the leadership team including Business Development Manager, Helen Miller-Viney, is now on its way to creating the community they envisioned. The impressive £7million facility will shortly be opening with Sartorius Stedim Lab and Bioscience Ventures Ltd already about to take up residency.

The 4,500 sq. ft. laboratory facility is the first of its kind in the UK, boasting specialist rooms including areas for Category 2 microbiology, a freezer facility down to -150°C, a microscopy lab, sterilisation facilities and a cryogenic suite for housing liquid nitrogen. There are office desks and hi-speed broadband provided, and if the tenants require, business advice and guidance available in, BizzInn, the business incubator just next-door and also part of the The BioHub Birmingham® project.

“When you’re really focused on turning an idea into something tangible and also at the very early stage of setting up and running a business,” James adds, “it can be hard to step back and look at everything, so having experienced professionals to mentor can make all the difference.

“Now start-up biomedical companies can have access to affordable wet-space and advanced research equipment plus science and business support – to give them everything they need to transform their ideas into commercial reality.”

“It’s all about the community,” he adds. “We want to create a place where conversation can stimulate new ways of thinking. I strongly believe that a group of inspired people is just as important as building the right kind of space and installing the right kind of equipment. When you’re new to entrepreneurship, you need this kind of social environment.”

THE BIOHUB BIRMINGHAM® SET TO BE THE REGION’S 'BIOMEDICAL INNOVATION LAUNCH PAD’

SPRING 2015

PLASTICS DESIGN AND MOULDING FOR THE MEDICAL SECTOR AT PDM15The 10th anniversary Plastics Design and Moulding Exhibition and Conference (PDM15) returns to Telford this June with a host of new exhibitors and a wealth of learning opportunities. Aimed at design and moulding professionals, the UK’s premier annual event for the plastics industry will take place at the Telford International Centre on 16 and 17 June 2015.

This year’s event will be co-located with the second Plastics Recycling Expo and the new Plastics Packaging Show. The event has already attracted stand bookings from over 100 companies. Visitors who register for PDM will have access to the exhibition floor of all three events as well as a high quality conference programme.

The medical sector has always been a strong focus of PDM. In this year’s PDM Conference, David Swann, Subject Area Leader at the University of Huddersfield discusses ‘Injection Moulding healthcare innovation; the 21st century nursing bag’. Industry skills shortages, EU membership, sustainable design, innovation and 3D printing will be among the other issues tackled in the PDM Conference which also includes a number of ‘shop floor’ sessions for engineers, providing practical expertise in areas such as moulding techniques and machine care.

PDM15 exhibitors that work in the medical field include Arburg Limited, Boddingtons Plastics, E.M.P Srl, Sprint Tool & Die Ltd and Velox (UK) Ltd, among many others.

Organisers have also reported a new level of interest from overseas businesses keen to showcase their capabilities to the UK market, now regarded as the growth area in Europe.

New exhibitors from across Europe include Italian-based M.P Srl, Austrian-based Meusburger Georg GmbH & Co Kg, Swiss company U-NICA Gruppe, 3D Design Technologies Ltd (Cad2parts Ltd) from Turkey and Luxembourg-based CODPRO.

Industry support for the PDM event continues to grow with the Society of Plastics Engineers UK & Ireland (SPE) and Rubber & Plastics Research Association (RAPRA) now joining existing partners British Plastics Federation (BPF), the Gauge & Toolmakers Association (GTMA), IOM3, Polymer Training and Innovation Centre and the Polymer Machinery Manufacturers and Distributors Association (PMMDA), Polymer Society and WRAP.

The National Institute for Health Research (NIHR) Colorectal Therapies Healthcare Technology Co-operative (HTC) is a national centre of expertise for the development of technologies in the area of colorectal disease. The focus of the HTC is minimally invasive therapies for disease and translating scientific innovation in engineering, nanotechnology and biosensing into clinical application.

This exciting, FREE event is to enable the next steps to be taken in identifying novel solutions to a series of previously identified clinical needs which include the following: • Personalised surgery • Next generation ‘intelligent’ instruments • Enhancement and monitoring of postoperative surgery • Rapid early detection of disease, including ‘real time’ bedside diagnostics • Prevention and early detection of postoperative complications

This workshop will provide an opportunity for clinicians, scientists, engineers and industry partners already involved in device technologies, or with an interest in applying existing technologies to new problems, to work with the HTC to accelerate new science into clinical application. Registration is free. Places are limited and will be allocated on a first come first serve basis. Lunch and refreshments will be provided.

Click here to register.

To view the full exhibitor list and conference programme, and to register to attend free of charge - click here.

COULD YOU USE YOUR EXPERTISE TO HELP SOLVE UNMET CLINICAL NEEDS IN THE NHS?NIHR are looking for innovative and creative Scientists and Engineers, Clinicians, Industrial partners and Patients to collaborate in developing technological solutions to address unmet clinical needs.MIDLANDS REGIONAL MEETING, 23 APRIL 2015, 09:30-17:00, THE STUDIO, BIRMINGHAM

SPRING 2015

HDTI ERDF FUNDING HELPS INVENTOR LAUNCH HANDSTEADY The inventor of a cup designed to help people who might otherwise struggle to drink independently without spilling the contents aims to raise £10,000 from a crowd-fundingscheme. handSteady has already won awards from Help the Aged, and The Guardianand has also received a scholarship from Dyson.

Chris Peacock, whose company manufactures the product and distributes it fromKenilworth, believes the cup, which features a unique large rotatable handle and hidden lid, is ideal for people who have a range of conditions including tremors, limited dexterity, slow movement, swallowing difficulties, a weak grip caused by a stroke,multiple sclerosis, rheumatoid arthritis, joint or muscle pain and stiffness.

He commissioned Coventry University Health Design & Technology Institute (HDTI) to carry out a usability study to evaluate handSteady after realising he was eligible for five days of free consultancy support through HDTI’s Assistive Technologies and Community Healthcare Development Project from the European Regional Development Fund (ERDF).

HDTI focuses on helping entrepreneurs, inventors and companies develop their ideas for products that help people with disabilities and long-term conditions to live more independently. The ERDF funding is available to small and medium sized businesses in the West Midlands region.

Feedback was positive and Chris is now aiming to raise £10,000 from a crowd funding scheme at http://igg.me/at/cuppa before April 24 with the aim of receiving enough pre-orders to place a large manufacturing order to reduce the retail price of the cup.Guy Smallman, commercial development director at HDTI, said handSteady looks like an everyday cup rather than a disability aid.

TRY THIS TO SET CLEAR, STRAIGHTFORWARDGOALS, SO YOU DEVELOP THE RIGHT PRODUCT Written by Fiona Theobald, Quality Factors Director, ThreeCircles Ltd I had a flash of inspiration during lunch with a colleague last Friday. Our conversation included how difficult it seems to be to set a clear, concise statement of the objective for developing a device (or indeed any product). The conversation drifted from there to the most memorable presentations we'd experienced.

My eureka moment; the power of a story to anchor and clearly describe the objective. I'd like to share with you an experience that I still vividly recall.

There was an AAMI/FDA meeting in early 2012. On the first afternoon, I listened to a series ofpresentations around the perhaps dry topic of “device clock synchronisation challenges”. After hearing several speakers talk about technicalities, standards and protocols, I still didn’t really appreciate what the pressing issue was. Then James Fackler, MD (The Johns Hopkins University School of Medicine) shared his experience of working in a paediatric ICU...

The first slide was of a large bank of very similar looking devices in an ICU. The doctor was faced with banks of instruments all humming and bleeping away, all alerting them to their patient’s bodily functions.

Slide two had a graph of an output versus time from one of the instruments. The chart was explained, then a second graph was added, followed by a third, fourth and fifth; each with a trace from another device in the ICU, potentially covering the same 30 second time period.

The MD then talked about the blips on the traces and what they meant to the healthcare professional. Then came the shock.

The blips on each of the charts showed failure of a different bodily function. Crucially, the relative timings of these blips meant a different surgical procedure may be needed to save the patient, a child. It was like a smack on the forehead!

I understood how important the chart accuracy was to the doctor. A decision how to proceed has to be made within that 30 second window, so device clock synchronisation was critical to presenting the correct sequence of blips that pinpointed the next steps. The doctor is wholly reliant on data from all the devices being accurately displayed, at the right time points, in order to select the appropriate treatment.

Device clock synchronisation suddenly became a matter of life and death. Encapsulating the problem in a story, clearly presented what needed to be solved and why it mattered, in a straightforward and profound way.

As an aside, although there were no hand-outs from this session, it's the one I recall most readily from the meeting.

Maybe, as you read this post, you reached the same realisation about the life saving importance of device time synchronisation. How powerful it would be if you described your development goals in terms of what it will mean for the eventual user; described them so that everyone understands exactly the imperative you're working to address.

To find out more about Medilink member Three Circles - Click here.

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Please click here for more information on entering and attending the awards. Nominations for this event will close on 30 March 2015.

• Manufacturing Innovation AwardThis award is for the Midlands company that has created a new product, system or design that is set to make a major impact. » Submit your entry

• Advanced Manufacturing / Technology AwardThis award is for the company deemed to have consistently best used technology or technical processes to solve problems or add value to customers. » Submit your entry

• Sustainable Manufacturer of the YearThis award is for the company that has demonstrated the greatest commitment, through its products or internal processes, to forging a low carbon manufacturing future for the Midlands. » Submit your entry

• Exporter of the Year AwardThe award is for the company that proves to have had the most exciting impact on exports, either by breaking into new markets, impressive development or existing targets. » Submit your entry

• Apprenticeship & Training AwardThe Apprenticeship & Training Award recognises the manufacturing business that has done most to further the cause of apprenticeships in the Midlands. » Submit your entry

• Large manufacturer (£20m turnover upwards)This award is for the company deemed by the judges to be the most impressive large manufacturer with reference to sales growth, market leadership and overall value to the Midlands economy. » Submit your entry

• Small manufacturer (up to £20m turnover)This award is for the company deemed by the judges to be the most impressive small manufacturer with reference to sales growth, business development and innovation. » Submit your entry

• Food and Drink AwardThis award is for the food and drink company deemed by the judges to be the most impressive taking into account innovation, commercial success and business development. » Submit your entry

CELEBRATE YOUR ACHIEVEMENTS!ENTER BEFORE 30 MARCHThe Insider Made in the Midlands Awards 2015 will be taking place on the 20th May 2015. Entries are now open .