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WINTERNewsletter

WEST MIDLANDSMEDILINKNEWS

Malmaison, The Mailbox 16:00pm - 20:00pm - click here for more information

WM MEDICAL & HEALTHCARE BUSINESS AWARDS

JOIN US AT THE 2015

IN THIS ISSUE:

- Your Industry GatewayHELPING INDUSTRY TO DO BUSINESS WITH THE NHS

- Introduction to our NEW MEMBERS

- The Wellcome TrustOPEN SCIENCE PRIZE

HAPPY NEW YEAR

NEW YEAR - NEW COURSES - NEW SAVINGS! ...

WMAHSN ONLINE HEALTHINNOVATION PLATFORM

FOLLOW US:

@MEDILINKWM @MEDILINKUK

FiND OUT ABOUT:

reAD ON to find out about the

lATesT FUNDiNg cAlls...

3D

WINTER 2015

Adris Technologies LtdAdris Technologies Ltd is a family run, not for profit business, established in 2014 to research, develop and create technologies to aid people who suffer from epilepsy and heart conditions. PulseGuard is a heart rate monitor that detects seizure activity and any early onset of cardiac difficulty.

BHR Pharmaceuticals Ltd

Established 25 years ago, BHR Pharmaceuticals Ltd, a market leader in the provision of Point Of Care diagnostics, specialises in delivering the most technically advanced products and solutions enabling healthcare professionals to diagnose, treat and manage many of today’s most prevalent diseases/conditions.

Medical Engineering Technologies (MET) Ltd

MET started providing technical and scientific solutions to medical device manufacturers in 1997 and supply specialist testing and validation services with wide-ranging study capabilities. MET's flagship activity lies in the testing and validation of medical devices and their packaging, conducted in their ISO 17025 accredited laboratory facilities.

Quantum Imaging

Quantum Imaging is a privately held medical device company focused on the utilisation of advanced quantumprinciples in the rapid detection of potentially life threatening medical conditions in acute medical settings. The Quantum Vitalscan is a simple 3 – 5 minute RULE OUT test that produces results on-site with very high Negative Predictive Value.

Talking Products

Established in 2002, Talking Products design and manufacture a unique range of voice recordable products that are useful to people who are visually impaired or those suffering with memory loss, as well as an associated pre-recorded range of promotional products.

Vaisala

Vaisala provide systems and services to reduce the risk posed by environmental deviations in critical assets and work areas. Continuous monitoring of any sensitive environment helps organisations to meet their security and regulatory compliance needs. Vaisala already keeps 3,200 pharmaceutical, medical and biotech environments compliant.

Featuring

5 Calling all Health Innovations looking for Adoption Wmahsn launches meridian

6 Medilink Business Awards Find out Who has been shortlisted For

this year's aWards

13 West Midlands Academic Health Science Network Find out about the Wmahsn's neW digital

health incubator

14 Bridging the Valley of Death for Medical Technology Developers read about the nihr i4i programme

16 Global Medical Device Regulations Update

18 2 Dimensional Datamatrix Barcode Labels Made Simple by goldcrest

22 Spring Active premiertm programme For backpain

23 NIHR i4i Calls for Funding

25 Kimal Plc Invests Profits into R&D read about kimal's neW innovation centre

28 Events

NEW MEMBERS

WINTER 2015

NEw YEAR - NEw COURSES - NEw SAVINgS!2015 saw Medilink as a key delivery partner under the Science Industry Partnership (SIP), providing subsidised, specialist training to Life Science companies.

We welcomed over 400 learners during the 9 months the programme ran and we saved companies over £180k in course fees through the SIP grant. Unfortunately SIP funding has now closed; however, Medilink believes that the need for quality training remains; at prices the SME industry can afford.

So, from January 2016, Medilink will continue to offer you the opportunity to grow the skills of your organisation whilst ensuring excellent value for money for you. We have negotiated some exceptional rates with leading experts across your sector; including medical standard’s authorities GS1 UK and LRQA.

In partnership with our extensive bank of expert training providers, Medilink will continue to champion our sector’s skills needs and further develop services to address these needs by MAINTAINING THE SUBSIDISED DELEGATE RATE you enjoyed through the SIP – with full-day course fees starting at as little as £140!

We are keen to ensure we provide what you need so please do get in touch if there are particular topics you think should be featured in our 2016 training calendar.

For further information, please contact Rebecca Ridley:

E: RebeccaR@MedilinkWM.co.uk

INNOVATION FUND: IMPROVING THE LIVES AND WELLBEING OF YOUNG PEOPLEAn initiative to support and fund projects that improve the lives of young people suffering from mental health issues has been launched.

Applications are invited from any organisation working to improve the quality of mental health services to children and young people (aged up to 18 years).

The Children’s and Young People’s Mental Health Innovation Fund aims to encourage innovation in the development of mental health services to children and young people.

Deadline for applications: Friday 15 January 2016.

For full details on how to apply, the criteria and eligibility, and read the guidance for applicants, visit the HEE website for more information - click here.

WINTER 2015

UNLOCK YOUR POTENTIAL TO DO BUSINESS wITH THE NHS

we know that many SME’s find it hard to access the NHS or to let them know about your innovations.

That’s why Medilink wM, as part of its role with the wMAHSN Innovation and Adoption Service is able to help you improve your profile, relationships and collaboration with the NHS.

Medilink wM, alongside wMAHSN, is supporting industry to overcome historic barriers to understanding and adopting innovation by forming closer links between the NHS, industry and academia and by developing the infrastructure to improve the scale and speed of adoption at pace and effective healthcare across the west Midlands.

we are working with our partners in and outside the NHS to accelerate the take up of known best practice and to identify gaps in current provision. For industry we provide a front door to the NHS to accelerate adoption and help you to navigate our region.

we are looking for the best solutions to transform care.

west Midlands NHS is looking for the best solutions to transform care and treatment, and they will be using the Meridian Online Health Innovation Platform to identify and find those solutions.

So if you have an innovative product or service available that has significant potential to benefit both patients and the NHS and you wish to get in front of clinicians and health professionals then get in touch with Medilink WM. We will help you to gain a higher profile within the NHS in the West Midlands ... and beyond.

For more information or to discuss your innovation in greater detail please contact Chris Dyke (ChrisD@MedilinkwM.co.uk) or Joanne Mewis (JoanneM@MedilinkwM.co.uk) or

telephone 0121 452 5630.

If you have the products, the services or the innovative thinking, and want to sell into the NHS REMEMBER Medilink wM is the wMAHSN industry gateway helping industry to do business with west Midlands NHS.

Do you have an innovative product or service that you wish to introduce into the NHS?

As the industry gateway we will guide you and provide the support you need

WINTER 2015

sOlUTiONs Are cUrreNTly sOUghT FOr: Data Analytics to Support Better Mental Health and Care: How can the NHS make better use of data analytics to improve mental wellbeing, to drive improvement in delivering mental health services, and optimise users' experience and outcomes?

Mental Health Crisis Care: How can digital tools support people at risk of mental health crisis? These may involve using data to predict when a crisis is likely to occur, alerting service users, carers and professionals when risks of crisis are elevated.

Falls Prevention MOOC (Massive Open Online Course): EIT Health are considering developing a MOOC for healthcare professionals and members of the public about fall prevention in frail elderly people – what experience and knowledge is there in the west Midlands to do this?

Single Version of my medicine: How can handovers and information sharing about a person’s medicine be shared more effectively? what systems, processes, protocols or enablers are in place that can help the region do this more effectively and consistently?

CALLINg ALL HEALTH INNOVATIONS LOOKINg FOR ADOPTION!

Meridian: delivering a step-change in the way

West Midlands NHS identifies, develops and

adopts new innovative products and services.

shAre yOUr iDeAs - BUilD grOUPs, cONTAcTs AND NeTWOrks

For more information on the solutions sought, the Meridian Online Health Platform, to request a Meridian submission form or let us know about your innovative solution please contact either Chris Dyke (ChrisD@MedilinkwM.co.uk) or Joanne Mewis (JoanneM@MedilinkwM.co.uk) or phone 0121 452 5630.

hOW cAN We helP?• Help to actively promote your innovative solution on the

Meridian platform to west Midlands NHS and beyond• Bespoke advice on the steps you should be taking to

progress your innovation and engage with west Midlands NHS with fewer unanticipated obstacles

• Review and advise you on your innovation submission• work with you to gain a higher profile in the NHS for your

innovation• Support you throughout the process

We Want to knoW about your product or technology eveN iF iT's NOT mArkeT reADy yeT

We will signpost you to an organisation or someone to help you along your development path

WMAHSN launches Meridian Online Health Platform

Among the new features of the innovation and adoption theme is the wMAHSN-developed Meridian online health innovation platform. Meridian has been specifically designed to support the west Midlands' innovation ecosystem, assisting NHS, academic, commercial and industrial stakeholders and supporting a collaborative approach to resolving clinical and service challenges, building a region-wide innovation culture.

get in touch and we can help you to promote your innovative product or service on Meridian to help you gain a higher profile in the NHS. Innovation submissions will need to outline the key benefits that can be brought to patients, as well as to the NHS (e.g. time, resources, funding etc).

Innovations sought should be market ready or near market ready and fully certified and preferably adopted elsewhere by the NHS, CCg, Private Health Organisation or possibly by an International Health Authority.

WINTER 2015

The awards dinner will be hosted on the 14th January 2016 at Malmaison Birmingham, one of Birmingham's most luxurious and popular hotels, situated at the heart of the Mailbox.

2015 MedilinkwM Medical and Healthcare Business Awards - shortlisted organisations:

Start Up Award – Sponsored by Calthorpe Estates

- Evolyst Ltd- KiddiChef.com UK Ltd- Spring Active Ltd

Innovation Award – Sponsored by Marks & Clerk

- KiddiChef.com UK Ltd- Kimal Plc- Primasil Silicones Ltd

Partnership with the NHS Award – Sponsored by

West Midlands Academic Health Science Network (WMAHSN)

- Digital Life Sciences- Entec Health Ltd- Physiological Measurements Ltd

Export Achievement Award – Sponsored by UK Trade

and Invest (UKTI)

- Kimal Plc- Nutrahealth Plc

Outstanding Achievement Award – Sponsored by

University of Birmingham

- Integro Pharmacy- Kimal Plc- Nutrahealth Plc

This Year’s Ones to watch- Accutronics Ltd- Renfrew Group International

Over the past year Medilink WM has had the privilege to work closely with some of the region’s most innovative and successful medical and healthcare companies and we are delighted toannounce the shortlisted organisations for the 2015 MedilinkWM Medical and Healthcare Business Awards

SHORTLISTED ORGANISATIONS ANNOUNCED FOR 2015 MEDILINKWM MEDICAL AND HEALTHCARE BUSINESS AWARDS

Our winners will go on to represent the region at the national Medilink UK Awards, which will take place at the MedTech Innovation Expo, Ricoh Arena, Coventry in April 2016.

We'd like to take this opportunity to wish all of the shortlisted companies good luck, and we look forward to the grand unveiling next week!

The annual Medilink West Midlands Medical and Healthcare Business Awards is the premier event in the region's healthcare technology calendar, bringing together leading organisations from across the sector.

WINTER 2015

Many thanks to our Sponsors

BOOK YOUR PLACE! MEDILINKwM MEDICAL AND HEALTHCARE BUSINESS AwARDS 2015

Celebrating the Excellence of the west Midlands Healthcare Technology Sector

AwARDS DINNER & CEREMONY14th January 2016 - 4pm - 8pmMalmaison, The Mailbox, Birmingham

MedilinkWM invites you to join us for the 2015 Medical & Healthcare Business Awards on the 14th January 2016 at Malmaison Birmingham, one of Birmingham's most luxurious and popular hotels, situated at the heart of the Mailbox.

The evening will open with a welcome from our 2015 Networking Reception sponsor Ingram, Hawkins and Nock, giving you plenty of time to network with other organisations whilst enjoying a fun-filled, heart-racing activity!

Delegates will then be seated to enjoy a 2 course classically inspired seasonal meal, before beginning the Awards Ceremony. Although the event is scheduled to finish at 8pm, you are more than welcome to stay and continue networking in the bar area for as long as you wish.

Shortlisted organisations and sponsors will receive 2 free places to attend the Dinner & Awards Ceremony.

Member Fee: £30 + VATNon-Member Fee: £35 + VAT

If you would like further information on the MedilinkwM Medical & Healthcare Business Awards Dinner please contact Sarah wootton:E: Sarahw@MedilinkwM.co.ukT: 0121 452 5630

WINTER 2015

iNTellecTUAl PrOPerTy refers to a company’s patents, ideas and trade secrets, which are the key and life source of many businesses. Due to the complex nature of a company’s intellectual property (it isn’t aphysical object that can be easily quantifiable) standard policies look to exclude these in comprehensive commercial insurance policies. ADF Insurance can offer Intellectual property cover that can be tailored to a wide variety of businesses in order to protect these valuable assets.

Companies can spend a large amount of money, time and energy into building their intellectual property. Such a significant investment should be insured and protected.

Medilink member ADF Insurance can find an insurance policy to meet your company’s needs throughout its establishment, whether you are a start-up or a mature, well-established firm. They canoffer well-rounded cover for your business and its directors in relation to: pursuit actions, defenceactions, loss of profit, contractual risks and loss or IP or mitigation rights.

Intellectual property insurance allows a company to meet indemnities in customer contracts without risking bankruptcy; it works as a business enabler. This means smaller businesses can sign up to contracts with larger companies to meet their high demands and grow as a business.

ADF INSURANCE:TEN REASONS wHY YOU SHOULD BUY INTELLECTUAL PROPERTY INSURANCE

We agree that you know what is best for your company. So where do we come in?

We can provide insurers with expertise in seeking out the best strategy to handle your claim pro-actively as well as allowing your company to have the freedom it needs.

“Intellectual property wordings are full of insurance jargon”. We are happy to explain and go through any of your queries within the insurance policy wording, so you know exactly what’s covered. The insurance industry’s regulatory and authorizing body asks for those of us in the industry to ensure that information provided to customers is clear, fair and not-misleading. This is something we aim to provide.

We realise that insurance doesn’t provide comfort or benefits unless the events you are insuring against are covered all the time. We can find a policy with littleexclusion to reduce any unwanted surprises in the event of a claim.

Can you afford not to insure your intellectual property?

The legal costs associated with litigation are very high whether you are infringed or not; if you cannot afford to defend yourself and keep the company afloat in the often long litigation process, the opposition may get their way in a case against your company.

Obtaining Intellectual property insurance has previously been a long and drawn-out process.

With our very personalised team you will be able to deal with one dedicated member and keep in constant contact with them whilst we obtain all the information we need to get your quote.

If you are interested in reading more about intellectual property insurance please read our product page. If you would like to enquire about receiving a quotation for intellectual property insurance, click here.

WINTER 2015

VIDEO IS FOR LIFE, NOTJUST FOR CHRISTMAS

Once upon a Time, though not very long ago, the British public

fell in love, with a Christmas video…

NEW PRODUCTS FORALVOLUTION.CO.UK

The UNiversiTy OF BirmiNghAm is pleased to announce the launch of its first Business withBirmingham InnovationCompetition in order to celebrate entrepreneurship and innovation. The competition was launched at the Business with Birminghamannual conference on 20November 2015, with winners to be announced in 2016.

ADRIS TECHNOLOGIES

PULSEgUARD

With Apps becoming an increasing source of quick relief for a world that survives on virtualinteraction, fast access and at-the-fingertipinformation, Pulseguard is a form of instantmessaging that can save lives, giving access to coronary snapchats in a fast-paced reality where a 10 second delay can cause permanent loss ...

Pulseguard is an innovative heart monitoringsystem that comes with a wrist pulse monitor that acts as a synaptic link to a pre-installed PulseGuard app (an iPad is also included in the pack) to enable the electrical transmission of heart rate into clear visual translation.

Designed specifically to create an alarm when pulse rate falls outside expected parameters, PulseGuard uses Bluetooth technology and a wireless sensor to monitor heart rate, providing the assistance needed by those with epilepsy or any other condition where accurate heart rate monitoring means the ability to provide early warnings of an adverse medical condition - click here.

BUSINESS WITH BIRMINGHAM 2016 INNOVATION COMPETITION

TALKING PRODUCTS

TALKINg MEMORY BOOKS

While age is a natural part of life, part of what makes life extraordinary is our ability to conjure up time past into time present - a song, a name, a picture, a word, can all prompt a story ...

Decline of memory is one of the many symptoms of dementia and Alzheimer’s, causing the life stories that should form a background for conversation to instead blur into the background.

With 20 pages for photos, the Talking Memory Book is an incredibly useful memory aid for people with Dementia or Alzheimer’s as well as adults and children with visual impairment or learning disabilities. With up to 10 minutes of recording time on each page, the Talking Memory Book acts as a mental stylus, transducing sound to amplify the mnemonic lens when photographs alone are unable to capture scenic moments - click here.

Businesses are invited to apply in the followingcategories:

• High Growth Innovative SME of the Year - sponsored by R&D Tax Claims Ltd. £5,000 will be made available to the winning company to support collaborative R&D.

• Best Innovative Idea for Exploitation - sponsored by Forresters. The winner will receive £5,000 of

Intellectual Property advice, including patent and trademark attorney support.

Applications must be submitted to by no later than 17:00 on Monday 21 March 2016.

Click here for more information.

Imagen understand the importance of video, and their enterprise video platform, Imagen, helps companies of all sizes and industries to preserve and navigate their ever growing media libraries. From small independent businesses, to archives of national importance, Imagen enables content owners to create internal video libraries, clip sales platforms, and online VOD packages – delivering the best possible user experience to audiences through a highly customisable, elegant and rich web interface. To find out more, click here.

WINTER 2015

25 February 2016

Digital Healthcare Revolution: Harnessing NHS TechnologyThe Royal National Hotel,, Russell Square, London

To book your place or find out more, click here.

EVENTS

26 January 2016

west Midlands Health Informatics Network (wIN) Annual Conference Rootes Social Building, University of warwick, Coventry

The aim of the day is to showcase innovation and research, share good practice and experience and promote networking across healthcare.

Academic Health Science Networks (AHSNs)

First proposed in the Innovation Health and Wealth report by Chief Executive of NHS England, Sir David Nicholson, Academic Health Science Networks (AHSNs) were introduced by Prime Minister, David Cameron, in May 2013. Their aim is to encourage innovation in healthcare, and in doing so optimisepatient outcomes and economic growth in the UK.

West Midlands Academic Health Science Network (WMAHSN)

WMAHSN became one of the 15 designated AHSNs in England in May 2013. Joining Tony Davis asCommercial Director, Dr Christopher Parker became Managing Director of the WMAHSN in January 2014.

Drawing in investment, knowledge and expertise to induce progression into the healthcare industry, the WMAHSN creates a solid network that promotes new ideas while paving a way for their realisation, adoption and commercialization in order to optimize healthcare delivery across the West Midlands.

In order achieve their aims, the WMAHSN:

• Network - creates a network that links the expertise of NHS commissioners, providers of NHS services, industry and academia; and the needs of patients, carers and the public in order to identify and drive healthcare innovations in the West Midlands. They provide a network that facilitates the dissemination of information, solidifies industry relationships, identifies healthcare challenges and offers solutions.

• Innovation - helps to identify, catalyse and promote healthcare innovation throughout the WestMidlands. Collating and enriching new ideas with the industry expertise and investments needed to aid exposure, they provide a gateway into leading centres of applied health research.

• Partnership - creates partnerships and coordinates collaborations between education, training,research, informatics and healthcare delivery.

• Digital Health - liaises with industry stakeholders to strengthen the West Midlands’ stance in the world of technological innovation, investing in its core strengths to create a solid regional network with a fibrotic grasp on digital health strong enough to sustain a worldwide reach.

wEST MIDLANDS ACADEMIC HEALTH SCIENCE NETwORKThe West Midlands Academic Health ScienceNetwork helps to support health and wealth across the west Midlands, establishing the links needed to drive development and prosperity in the region.

WINTER 2015

wELCOME TO NEw MEMBER ADRIS TECHNOLOgIES – A FAMILY RUN COMMUNITY INTEREST COMPANYNew Medilink member Adris Technologies Ltd was established in 2014 to research, develop and create technologies to detect and aid people who suffer from epilepsy and heart conditions.

PEACE OF MIND FOR PEOPLE wITH EPILEPSY AND THEIR FAMILIES

PulseGuard™ is a unique package of monitoring and personal family based aftercare and support, rather than just a monitoring system:

• PulseGuard™ provides continuous monitoring throughout the night or day.

• Every time the alarm is triggered, the data is collected and stored. This can then be turned into a graph and shared with your consultant to help with future treatment.

PulseGuard™ can help patients with various heart conditions, epilepsy, diabetes and Postural Tachycardia Syndrome.

PulseGuard™ is a watch type sensor designed for use on young children right the way through to adults. The strap is soft, pliable and breathable. Made from a non-allergen material that will not aggravate the most delicate of skins, the completely wireless sensor transmits data via Bluetooth technology to the PulseGuard™ App downloaded to an iPad or iPad mini. The Heart Rate is accurately detected by reading the blood flow through the capillaries under the skin on the arm or leg, so no false alarms from poor peripheral circulation.

PulseGuard™ is designed and engineered by a family directly affected by epilepsy for families directly affected by epilepsy. It triggers an alarm if danger signs are detected so carers or family can take action.

The Pulseguard™ Pro harnesses wireless technology, and the possibilities of the‘Internet of Things’, to provide a cleversolution. The nonintrusive system gathers heart rate data round-the-clock, which can be checked from a remote screen.

The device also provides data to fuel future research and can be adapted to solve a range of healthcare problems. The team has already sold over 150 units of the PulseGuard™ system. Nominet Trust is providing the funding to help them take it to the next level, and protect against future deaths in aresidential or care home setting.

To find out more, click here.

The Perry family developed PulseGuard™ for their son Tom, who has suffered from the rare Dravet Syndrome since birth. His parents Adrian and Sue were so worried about his overnight seizures that they rigged up CCTV in his bedroom to see how many fits he was having. They realised that the monitoring equipment in place was not always able to detect every seizure, so his father Adrian and brother Chris set up Adris Technologies and developed PulseGuard™.

WINTER 2015

EXPORT INSIGHT VISITS 2016Short overseas business trips for First-TimeExporters from UK Trade & Investment (UKTI),designed to increase your understanding on how to sell your goods or services in international markets.

Export Insight Visits are part of UKTI’s First-TimeExporters package of support and are open to small and medium-sized businesses with little or nointernational business experience. See website for full details and eligibility criteria - click here.

New Medilink member Talking Products Ltd design, manufacture and distribute a wide range of products to a number of different markets worldwide, including products for people with a visual impairment, Alzheimer's or Dementia. Record and play messages to provide audible guidance for medication management, appointments, contacts and procedures.

Talking Products design a unique range of voice recordable products and associated pre-recorded promotional products. Their exclusive range of recordable products can deliver your message with the power of sound.

PRODUCTS THAT SPEAK FOR THEMSELVES!

EXPORT INSIGHT VISIT TO IBERIA18th Jan 2016 - 20th Jan 2016

Explore the numerous opportunities for UK companies, across all sectors, to secure business in Spain andPortugal.

EXPORT INSIGHT VISIT TO THE HAGUE16th Feb 2016 - 18th Feb 2016

A short overseas business trip for First-Time Exporters from UK Trade & Investment, designed to increase your understanding of how to sell your goods or services inBenelux.

INTRODUCING NEW MEMBER TALKING PRODUCTS AND THEIR RANGE OF USEFUL PRODUCTS TO HELP

PEOPLE STAY INDEPENDENT

Talking Products

Their products can be used in a variety of different applications to many different markets that require an audible sound message or special sound affect.

Voice recordable and pre-recorded products include:

• Talking photo albums• Talking tins• Multi-message voice recorders• Talking badges• Talking labels• & many more…

To find out more visit the Talking Products website – click here.

These ALL INCLUSIVE trips will give you a taste of new markets and help you find new business:

WINTER 2015

wEST MIDLANDS ACADEMIC HEALTH SCIENCE NETwORK TO DELIVER A DIgITAL HEALTH INCUBATOR IN NEw £8M BUILDINg

The Digital Health incubator will launch when iCentrum®, located off the A38M Aston Expressway in central Birmingham, opens in March 2016, and will be instrumental in enabling the West Midlands to have the first digitally-enabled health economy in England.

The ground-breaking incubation centre will seek to accelerate the growth of early stage businesses with a tech product or service offering that addresses innovative solutions to those with long term conditions, promotes wellness and the prevention of illness, provides advanced diagnostics, genomics and precision medicine, or helps with the management of mental health.

Tony Davis, Commercial Director of the WMAHSN, said: “In the short time since our launch, we have generated £15m of savings for the region’s NHS by introducing new innovations. We have identified digital health as our major enabler, which is why we are partnering with Innovation Birmingham to deliver a brand-new incubator for early stage tech companies.

“We want to work with brilliant, creative tech start-ups to pioneer solutions for patients to be able to access their own patient data and records. If a consultant delivers upsetting news, accessing the assessment and diagnosis online to share with family would be hugely beneficial to many. Filtering treatment levels for various ailments, and helping patients to self-manage long term conditions are other areas where there is significant scope for fresh innovation.

“The England-wide Academic Health Science Networks have been established to open doors to the right people in the NHS and wider healthcare market. The early stage tech companies that we work with in the Serendip Digital Health incubator will be given access to all the innovation challenges that healthcare practitioners and managers identify.”

Innovation Birmingham’s business mentors will actively work in the Digital Health incubator. There will also be mentoring from industry experts, access to big data and exclusive insight into innovation challenges facing the healthcare industry. Representatives from the WMAHSN will have a base within the incubator, in order to open doors to the local and national healthcare marketplace.

The WMAHSN will deliver the Digital Health incubator for an initial three year term.

The APPlicATiON PrOcess for early stage tech businesses will be launched in eArly 2016.

The West Midlands Academic Health Science Network (WMAHSN) has signed up as the partner to deliver a new Digital Health incubator in the new year. The challenge-led facility, which will enable tech start-ups to access the region’s network of NHS Trusts and Clinical Commissioning Groups, will be featured within the 2,500 sq ft Innovation Birmingham’s Serendip® Smart City Incubator in the new £8m iCentrum® building.

WINTER 2015

The NIHR i4i product development stream funds collaborative projects between at least two partners from academia, the NHS and industry. The funding and business advice provided by NIHR i4i support the development of early-stage innovations, generally at proof of concept and prototype stages. Since its inception, the product development stream has supported 170 projects, led by 146 principal investigators.

An independent evaluation of the NIHR i4i programme has been provided by RAND Europe.

Funding by NIHR i4i has proved beneficial to a number ofcompanies that managed to bridge the ‘valley of death’ from proof of concept to commercialisation and now have attracted capital from investors to further grow business. The examples that follow are showcases of companies funded by NIHR i4i.

BRIDGING THE VALLEY OF DEATH FOR MEDICAL TECHNOLOGY DEVELOPERS

The NIHR i4i programme supports the development of innovative medical technologies for patient benefit.

QuantuMDX, was launched in 2008 and is now a multinational company. Currently, molecular diagnostic testing requires samples to be run on expensive equipment in a central laboratory. QuantuMDX secured £74,978 of NIHR i4i funding between 2009 and 2010 to develop a biosensor to incorporate into a handheld DNA sequencing device. This was followed by £1,097,297 between 2011 and 2014 to develop a novelnanotechnology DNA sequencing technology to integrate into a hand-held or bench-top device. These applications will move molecular diagnostic testing from hospital to the home and community setting.

Creo Medical, founded in 2003, is a medical device manufacturer. Bowel cancer is the second most common cause of cancer related death. After screening, most patients are referred to the general surgeon and treated by colorectal resection, which is a major surgical intervention with a high-risk profile that may require the patient to wear a colostomy bag for the rest of their life. Creo Medical secured £970,000 of NIHR i4i funding in 2013 and £940,000 of further funding between 2015 and 2017, to develop a family of endoscopic instruments for the safe, accurate and swift removal of pre-cancerous and early-stage cancerous growths in the bowel. In September 2015 it announced the completion of its latest financing round totalling $8.45 million. To date, Creo Medical has secured investment totalling $20.7 million.

Quanta Fluid Solutions Ltd, founded in 2008, is a developer of advanced haemodialysis systems. At present, haemodialysis is primarily provided by specialist clinics and centres. It is clinically proven that more regular dialysis improves outcomes and quality of life for the patient. Patient benefit, cost and clinic capacity are driving the growth of home and self care modalities of haemodialysis. A major factor limiting the growth of self care and home haemodialysis is the lack of convenient, portable and easy-to-use dialysis systems. Quanta Fluid Solutions is addressing this gap in patient care. It received an NIHR i4i award worth £547,560 between 2010 and 2012 and further £1,849,424 in August 2015, to end in 2018. It has recently attracted venture capital investment of £29 million.

WINTER 2015

The Open Science Prize iNviTes TechNOlOgy exPerTs AND iNveNTive reseArchers to come forward with new ideas for services, tools and platforms that will make it easier for academic scientists, citizen scientists,innovators and the wider public to discover and mine the vast treasure troves of digital information being generated through health research.

The competition seeks international teams to create novel open science platforms.

The Open Science Prize consists of a two-phase competition to make this digital information and data more accessible and usable. For the first phase, up to six teams will receive prizes of $80,000 to take new ideas for products or services to theprototype stage, or to further develop an existing early-stage prototype.

In the second phase, the team with theprototype judged to have the greatestpotential to advance open science willreceive a prize of $230,000. The Open Science Prize is open for entries until 29 February 2016.

For further information, click here.

Please see also the NIH press release and the wellcome Trust Blog by clicking here.

BHR Pharmaceuticals expand access to care by providing fully managed health screening services as well as consumer healthcare products.

BHR is committed to reducing healthinequalities and are pleased to announce the launch of their NHS Health Checkservices across the UK.

They are working with a number of County Council and public health leads in delivering NHS Health Checks through various deployment models,including the GP surgeries, Pharmacies and community outreach services, enabling patients toaccess an NHS Health Check at a venue and time convenient to them byimplementing and offering the service in various venues and settings depending on their customers’ needs and requirements.

THE WELLCOME TRUST OPEN SCIENCE PRIZE

wELCOMETO OUR NEw MEMBER BHR PHARMACEUTICALS LTD Established 25 years ago, in 1990,

BHR Pharmaceuticals Limited, a market leader in the provision of Point Of Care diagnostics, specialises in delivering the most technically advanced products and solutions enabling healthcare professionals to diagnose, treat and manage many of today’s most prevalent diseases/conditions.

BHR can provide a range of services from the provision of Point Of Care Testing equipment to a fully managed service, including clinical and QA support and delivering on target.

A new prize challenging innovators from around the world to unleash the huge potential of open access content and data for societal benefit was launched recently by the Big Data to Knowledge (BD2K) initiative of the National Institute of Health, the wellcome Trust, and the Howard Hughes Medical Institute.

WINTER 2015

GLOBAL MEDICAL DEVICE REGULATIONS UPDATEFind out the latest from regulators including new and proposed legislation and regulatory trends affecting thehealthcare product industries.

Importers of FDA-Regulated Products Prepare for February Shift to Automated System

In partnership with Customs and Border Protection (CBP) and 46 other government agencies, the Food and Drug Administration (FDA) has developed and is quickly transitioning to a new portal through which industry can electronically submit all data required by government agencies for international trade.

As of 28 February, 2016, all importers and brokers of FDA-regulated products will have to submit entry data through the new Automated Commercial Environment (ACE). And by the end of 2016, ACE will be the primary system through which the trade industry will report imports and exports and the government will determine admissibility.

To read the full RAPS article – click here.

Health Canada: Transition Plan for the Medical Device Single Audit Programme (MDSAP)

Health Canada intends to implement MDSAP as the sole mechanism for manufacturers to demonstrate compliance with the quality management system requirements of the Medical Devices Regulations. MDSAP will replace the current Canadian Medical Devices Conformity Assessment System (CMDCAS) program, even in situations when a manufacturer intends to sell only in Canada. This implementation will begin at the conclusion of the Pilot on 01 January 2017, and will span a period of two years.

To view the background and transition plan visit the Health Canada website – click here.

Brazilian Lawmakers Limit ANVISA Medical Device Fee Increases

Brazilian legislators have stepped in to limit substantial increases for quality management system inspection fees in a boon for ANVISA medical device registrants.

The country’s Ministry of Finance had pushed through massive fee spikes for Brazilian Good Manufacturing Practice (BGMP) certification that is now in effect, but lawmakers have now issued a new law, Law 13202/15 (link in Portuguese) limiting increases to 50% of prior fee amounts.

To view the full Emergo blog – click here.

Australian MDR: The Australian’s Medical Devices are regulated by TGA (Therapeutic GoodsAdministration), which is also a part of conformity assessment body for Australian’s Manufacturers- click here.

India MDR: Central drugs standard control organization (Director general of health services,Ministry of health and family welfare, Government of india) safeguards and enhances public health byassuring the safety, efficacy and quality of drugs, cosmetics and medical devices in India - click here.

China MDR: State Food Drug Administration (SFDA) is responsible for medical device regulations in China - click here.

WINTER 2015

SIMPLIFYING THE UK MEDICINES MANUFACTURING LANDSCAPE

gUesT OF hONOUr: Dr Paul Bate, Executive Director of Strategy and Intelligence, CQC

With the Care Quality Commission currently developing its five year strategy, this seminar will provide a timely opportunity to consider the future regulation of health and social care in England. Delegates will assess priorities for regulating primary care, hospitals and social care, as well as next steps for removing barriers to integration.

There will also be discussions on challenges for regulating health and social care in light of the recentSpending Review.

To find out more information, including the agenda and how to BOOk yOUr PlAce, please click here.

CD-ADAPCO'S gLOBAL wEBINAR Bonus Event Tuesday 19th January 2016

'simUlATiNg FlOW iNDUceD NOise AND viBrATiON FOr AccUrATe mODeliNg'

Medilink member Co-Adapco’s Global Webinar Program offers you the opportunity to explore and learn how simulation is being used to resolve engineering problems across a wide spectra of applications.

Events are complimentary, last no longer than one hour and are simple to both register for and join - click here.

Friday, 15th January 2016Central London

'Priorities for the Care Quality Commission'

Events are run globally, with broadcast in two time zones:

•10am (London) • 11am (Berlin/Paris) • 3:30pm (Bangalore) •10am (Los Angeles) • 1pm (New York)

Previous webinars are available as webinar recordings.

wESTMINSTER HEALTH FORUM SEMINAR

A new web portal has been launched that provides a simple and accessible platform outlining the UK’s strengths and capabilities in medicines manufacturing. It was developed by the Knowledge Transfer Network (KTN) on behalf of the Medicines Manufacturing Industry Partnership (MMIP).

The MMIP had previously discovered there was confusion about UK activity in this sector in terms of the current industry base, academic research, and support for innovation in medicines manufacturing. KTN’s Medicines Manufacturing Landscape portal highlights key UK activity, linking to existing initiatives to provide a seamless overview of the sector. In addition, the portal can be used to promote the UK’s capabilities to the UK community and internationally.

Access the Medicines Manufacturing Innovation Landscape portal here.

" It is the first example of an interactive tool that pulls together the innovation landscape, company base and manufacturing sites for the entire medicines sector within the country".

WINTER 2015

UKTI BUSINESS OPPORTUNITIES

Medilink member Goldcrest come up with the answer to customers' Tricky Track and Trace Test

As one of the UK’s leading Medical Label printers, Goldcrest were approached with a request to provide Track & Trace information for laboratory sampling.

Our Technical Representative was able to offer an overprint service to create customer specific 2D barcodes in a robust label format, which includes specialised materials for challenging situations and applications.

Goldcrest developed a small 2Ddatamatrix label for application onto their products that would survive a variety of extreme conditions and still provide a 100% scan and manual read rate.

With the ability to transfer this technological solution to a variety of demanding conditions, Goldcrest are available to develop individual solutions to suit your own requirements.

No matter how exacting a medical labelling specification and in the most demanding of environments, Goldcrest are standing by to offer you solutions.

2 Dimensional Datamatrix Barcode Label

Do you need to Track & Trace individual small products in a secure and hygienic environment and be able to hold and provide vast amounts of data?

To talk to our Technical Team, call 01869 243201 or visit our website - click here

CHINA – Pharmaceutical company or medical equipment manufacturersought for cooperation

A well-known Xi’an private group company is looking to cooperate with a British pharmaceutical company or medical equipment manufacturer. Its activities include retail and medicine.

The retail side of this business has distributed several well-known Western medicines and Chinese patent medicines, which have received good market responses over the past decade.

The potential partner should have good market reputation and produce cardio cerebrovascular drugs, immunity medicine and anti-cancer drugs.

The company would prefer to discuss cooperation with companies directly instead of via agents. Find out more - click here.

2 DIMENSIONAL DATAMATRIX BARCODE LABELS MADE SIMPLE

WINTER 2015

Excellence In Laboratory Analysis - Efficiently Delivered

New member Medical Engineering Technologies Ltd (MET) started providing technical and scientific solutions to medical device manufacturers in 1997.

Since then they have grown to be the trusted partner of many companies manufacturing medical, surgical or pharmaceutical products. This is no accident, but is the result of their dedicated efforts, their knowledge of the regulatory environment, their broad experience of devices and their production and the expert advice they are able to give on issues ranging from R&D to customer returns analysis.

MET’s services are accredited to ISO 17025 and they work hard ensure that these services are efficiently delivered, with project progress reported regularly. The variety of tests they offer has steadily grown to include many physical tests and chemicalanalyses. The devices they test are many and varied: dispensing systems, medical carts and trolleys, implants, face masks, just about everything.

wELCOME TO NEw MEMBER MEDICAL ENgINEERINg TECHNOLOgIES LTD

What MET Do

MET supply specialist testing and validation services with wide-ranging study capabilities. Time often being of the essence in the healthcare market, their efficient project management ensures they deliver accurate results quickly. MET sell and support a broad portfolio of packaging machines and quality assurance test equipment sourced from leading manufacturers. These machines have been used by medical device and pharmaceutical companies worldwide for decades, and MET therefore have a wealth of experience in catering to the stringent demands of the industry. Multiple technologies are utilised to provide customers with the best-suited, most reliable and cost-effective technical solutions. MET’s selected sterilisation consumables bring answers to the last stages of the production process.

MET's flagship activity lies in the testing and validation of medical devices and their packaging, conducted in their ISO 17025 accredited laboratory facilities in Kent. To support CE marking and FDA submissions, companies large and small come to MET for stability studies, sterile barrier studies, biocompatibility testing, bench testing and product complaint analysis. Strategic partnerships enable them to offer studies not yet available in-house, with the most recent one allowing them to conduct tests on interventional devices including radial force measurement, trackability and insertion forces and fatigue studies on heart valves and stents. 5 Reasons To Partner With MET

1. MET deliver independent design validation studies for your medical device, ISO 17025 recognised and accredited.2. MET’s knowledgeable engineers and scientists can develop efficient and effective testing protocols.3. MET’s experience of a very wide range of devices allows them to readily understand your new development and your particular needs.4. MET provide comprehensive testing regimes with regular reporting.5. MET’s easily understood reports include the detail required by regulatory authorities.

To find out more about MET and their speciality areas – click here.

WINTER 2015

NEw MEMBER QUANTUM IMAgINg LTD ENgAgED IN THE DEVELOPMENT OF INNOVATIVE IMAgINg TECHNOLOgIESNew Medilink member Quantum Imaging is a privately held medical device company based in the UK focused on the utilisation of advanced quantum principles in the rapid detection ofpotentially life threatening medical conditions in acute medical settings.

Research by Professor Ben Varcoe has led to the development of a portable and completely passive medical platform to detect and display the minute bio-magnetic signals associated with various tissues. These signals can be used in a variety of medical applications and for the detection of a range of medical conditions.

The company was formed to commercialise sensor technology developed by Professor Ben Varcoe, Chair of Quantum Information Science at Leeds University and has facilities in Leeds and in Warwickshire.

The first application of the technology will be to aid the rapid triage and identification of patients presenting to Emergency Departments with chest pain, but who ultimately have no cardiac related diagnosis. Identifying these patients early enables them to leave expensive cardiac diagnostic pathways so releasingresources to focus on other acute patients.

"Magnetocardiography is a rule out test and is proven to detect the absence of heart disease, allowing clinicians to RULE OUT patients early."

Current testing is a RULE IN test which means a positive test can identify heart problems, includingMyocardial Infarction; however, a negative test does not mean there is no disease present.

Magnetocardiography is a RULE OUT test and is proven to detect the absence of heart disease, allowing physicians to RULE OUT patients early.

Vitalscan from Quantum Imaging performs a simple and passive scan at the patient’s bedside in around 3 minutes; outputs can include a trace, numerical data and a 2D visual magnetic field map of the heart. The device can be used in a routine clinical area and is designed to be used by existing emergency room staff needing little additional training to that needed to perform a routine electrocardiogram (ECG).

Quantum Imaging has an experienced management team, with a mix of fundamental research, medical device commercialisation, manufacturing and global regulatory and clinical strategy.

To FiND OUT mOre about Quantum Imaging and the Quantum Vitalscan, a battery powered and portable medical device that can be used in a routine and acute hospital setting whilst maintaining the accuracy and efficacy of the older technology SQUID devices – click here.

WINTER 2015

FUNDINg COMPETITION OPEN FOR REgISTRATION

UK regulatory authority the Medicines and Health products Regulatory Agency (MHRA) has started todevelop guidance on human factors for medical devices. we are curious to see how the guidance will fit with the FDA’s guidance documents, published over the past few years.

The Agency has confirmed that the planned guidance will cover several topics:

• Pre-market regulatory framework (including end users) • Standards • Post-market surveillance regulatory framework • Simulation / Usablity

Origins of the MHRA Human Factors guidance

Development of the guidance is being managed by a task group set up by MHRA, with the involvement of notifiedbodies, academia, NICE, trade bodies and professional associations. The task group held its second meeting recently.

At the meeting, Dr Brian Edwards of the Clinical Human Factors Group emphasised the need to consider therequirements of combination products, saying:

“It’s important to work together in particular areas where we have overlapping interests such as drug/device combinations.”

Understanding Human Factors in medical device design

The task group was born out of a wider meeting held on 27th February 2015. The February meeting involved a wide cross-section of interested parties and considered how we can build better understandings of human factors into the design, regulation and use of medical devices, to promote patient safety.

The keynote presentation at this important event was delivered by Dr Ann Blandford, who we’ve had the pleasure of discussing human factors challenges with on several occasions over the past couple of years.

Next steps for MHRA guidance on Human Factors

The task group will have a further two meetings to develop the draft guidance. MHRA plan to follow up on the work already done, by sharing the draft guidance with a wider group in the Spring of 2016.

sUBscriBe TO OUr BlOg, to be among the first to hear about the content of the draft guidance when it is shared.

India–UK collaborative industrial research and development competition: Clean-tech, affordable healthcare and ICT

regisTrATiON is required to enter this competition.

Innovate UK and the Government of India are to invest up to £3.4 million in collaborative industrialresearch and development projects that propose new commercial solutions to critical challenges impacting the socio-economic growth and development of India in relation to its clean-tech, healthcare and ICT sectors.

Registration will close 1 Week BeFOre The cOmPeTiTiON APPlicATiON DeADliNe.

Competition Summary

• Funding Award: Up to £3.4 million• Opens: 09 Nov 2015, 00:00• Registration closes: 13 Apr 2016, 12:00

MHRA DEVELOPING HUMAN FACTORS GUIDANCE FOR MEDICAL DEVICES - by Medilink member,

Three Circles

WINTER 2015

SPRING ACTIVE PREMIER™ PROGRAMME With one third of the adult population affected by back pain, it’s not surprising to find out that “back pain” is the number one searched for complaint online. Unfortunately web advice can be patchy and often not evidence-based.

The evidence suggests that education and exercise is key, and the best approach to help people with long term back pain is to provide a Combined Physical and Psychological TreatmentProgramme, so that they are able to return to activities that are important to them.

Medilink member Spring Active has created a range of services to help individuals with back pain. From the moment pain starts, we can ensure the individual has the best advice to deal with, and effectively move forward from, an episode of back pain.

Premier™ Programme

For back pain lasting longer than 3 months and not responding to the usual interventions, we offer a residential, psychologist-led programme. The Premier™ Programme is a 2 week intensive Combined Physical & Psychological Treatment Programme and follows national and international guidelines for the management of long term back pain. It involves exercise and educational sessions, with an emphasis on working towards purposeful individualised goals and developing skills to improve back pain in the long term. We take a bio-psychosocial approach to back pain, with all Premier™ Programmes including Cognitive Behavioural Therapy (CBT) and exercise - read more here.

The next Premier™ Programme with availability 16th-27th May 2016.

Our On Demand™ service is a digital and physical “virtual” service that combines digital screening, HealthyBack™ e-Book and remote video consultations with a qualified physiotherapist (a Spring Active Back Coach). This approach supports remote learning and a supported self-management path to recovery - read more here.

All Spring Active programmes offer advice, information and education on the nature of non-specific back pain, staying physically active and continuing with normal activities where possible and providing the appropriate exercises for the individual.

Spring Active work closely with BackCare, the national registered charity (No: 256751) forback pain. Their aim is to significantly reduce the burden of back pain by providing information and advice to all people and organisations affected by back pain. They support scientific research into the causes, prevention and management of back pain.

Take back control with BackCare’s interactive back pain recovery programme. With its 10 practical back pain recovery steps, the TakeBackControl™ Workbook will help aid the individual’s ability to effectively move forward from an episode of back pain.

For more information on all Spring Active programmes please click here.

WINTER 2015

The NIHR is the research arm of the NHS and funds these awards forcompanies to develop R&D plans in collaboration with a university or an NHS organisation.

Product Development awards support R&D of medical devices, active implantable devices and in vitro diagnostic devices. Lead applicants may be from academia, industry or an NHS organisation and must be based in England. Calls are repeated two times per year.

Challenge awards are based on themed calls in areas of existing or emerging healthcare need.

NIHR i4i CALLS FOR FUNDING The National Institute for Health Research

(NIHR) invites applications to its Invention for Innovation (i4i) Programme. There are two types of award: Product Development awards and Challenge awards.

The current themes are:

• Oncology Diagnostics

The National Institute for Health Research (NIHR) Invention for Innovation (i4i) Challenge Awards invite applications in the area of Oncology Diagnostics, aiming to improve medical practice by better prevention, earlier and more precise diagnosis, early intervention and more tailored treatment, all of which can help improve clinical outcomes, avoid side effects, and contribute to overall cost savings.

• Trauma and Critical Care

Trauma is the leading cause of death among children and young adults and the number one cause of lost life years. Every year across England and Wales 10,000 people die after injury, and many thousands are left severely disabled for life. The National Audit Office estimated in 2010 that major trauma costs the NHS between £0.3 and £0.4 billion a year in immediate treatment, and that the annual lost economic output as a result of major trauma is between £3.3 and £3.7 billion.

To clarify whether your project is within scope or for any other questions, e-mail i4i@nihr.ac.uk.

Lead applicants must be from NHS organisations in England and form partnerships with UK universities and/or companies based and conducting R&D in the UK. The themes will be repeated in spring.

The calls open on Wednesday 11 November 2015. The deadline for outline applications for all calls is Wednesday 13 January 2016.

To apply - click here.

NIHR PUBLIC HEALTH RESEARCH PROGRAMME

The National Institute for Health Research (NIHR) Public Health Research Programme has launched a new UK-wide call for 'local interventions to reduce intake and harm from alcohol'.

Commissioned research is sought to evaluate public health interventions, providing new knowledge on the benefits, costs, acceptability and wider impacts of non-NHSinterventions intended to improve the health of the public and reduce inequalities in health.

The programme is open to researchers in England, Scotland, Wales and Northern Ireland. To find out more click here.

The deadline for applications is 26 April 2016 (1pm) - click here to APPly

WINTER 2015

NEW PRODUCTS FORALVOLUTION.CO.UK

TALKING PRODUCTS

SEN-CIT CARE MONITOR

Difficulty locating familiar places, disorientation and loss of memory can leave those suffering from dementia vulnerable, consequently transposing into a great source of worry for carers, friends and family.

SeN-Cit is a care monitoring device that alleviates these problems, restoring peace of mind via a sensor that tracks and detects irregularpatterns of behaviour, alerting carers via SMS text message when movement is not detected as expected, as well as checking for room temperature changes, power cuts and security.

Adding to the SeNCit unit, SeNCit + also comes equipped with home security features and a wireless door sensor that checks for exiting via external doors.

Checking for regular movement, the SeN-Cit care system helps to supplant concern by alerting you when there is a cause for concern, using technology to synthesise the comfort that constant check-ups seem unable to placate sufficiently for the ones you care for - click here.

TALKING PRODUCTS

TALKINg PIR SENSOR

Using an electronic sensor to sense movement and trigger detection, the Talking PIR Motion Sensor comes with a unique MP3 download and playback feature that allows you to create an audible warning for a restricted area, a greeting, or a comforting message, fusing technology with a personalised voice and familiarity.

With the ability to download speech, music and sound effects, your files can be played back easily and automatically once the sensor is activated, acting as an audible security alarm that allows you to issue step by step instructions, warnings and reminders to create the impact and attention needed to ensure the safety and security of those suffering from Dementia or Alzheimer’s while at the same time safekeeping their independence - click here.

NEW MEMBER VAISALA IS A GLOBAL LEADER IN ENVIRONMENT AND INDUSTRIAL MEASUREMENTBuilding on 75 years of experience, Vaisala contributes to a better quality of life by providing a comprehensive range of innovative observation and measurement products and services for chosen weather-related and industrial markets, including Life Science.

Vaisala provides systems and services to reduce the risk posed by environmental deviations in customer’s critical assets and work areas. Continuous monitoring of any sensitive environment helps organisations to meet their security and regulatory compliance needs.

With Vaisala’s continuous monitoring solution in place, you can focus on creating results.

Vaisala can offer:

• Instruments for measuring temperature, humidity, CO2, dewpoint, different pressure and other critical parameters• Continuous, secure and GxP compliant solution for monitoring your sensitive environments, including refrigerators• Services and support that ensure your systems areefficient and meet or exceed the most stringent compliance requirements.

Maybe that’s why most of the top 50 pharmaceutical companies already rely on Vaisala and they already keep 3,200 pharmaceutical, medical and biotech environments compliant.

To find out more about Vaisala and how they can help

your company – click here.

WINTER 2015

KIMAL INVESTS PROFITS INTO RESEARCH & DEVELOPMENTSajid Javid, MP for Bromsgrove and Secretary of State for Business, Innovation and Skills visited Medilink member Kimal Plc in Bromsgrove, worcestershire to officially open their new innovation centre.

Kimal plc have been in business for 50 years and began manufacturing and supplying customised procedure packs and vascular access devices for use across a range of clinical departments across the world; in Bromsgrove in the early 90’s.

As part of Kimal’s drive to bring affordable innovative technology to the healthcare market, the Kimal board has decided to invest in a brand new innovation cell situated within their Bromsgrove manufacturing plant. The cell will be home to state of the art equipment; with the first purchase being a brand new 3D printer. Amongst other things, Kimal will be using the cell to further develop their already ground-breaking Altius central venous catheter programme, which is at present aiding in the fight against CRBSI (catheter related blood stream infection) with its closed system and unique patented manufacturingtechnology.

Kimal as a company are proud to invest in providing resources to develop technology that will ultimately be able to improve patient outcomes. The company already has a solid track record when it comes to innovation, winning four government backed grants in the last two years. Projects in development currently include devices which will aid in the early detection of Sepsis, with the aid of such renowned clinicians as Dr. Ron Daniels, CEO of the UK Sepsis Trust to bring this technology to market.

The Kimal Innovation Centre

Accompanied by recently elected district councillor (Aston Fields Ward) Phil Thomas, Sajid Javid arrived at the Kimal Plc premises in Bromsgrove on Friday 6th October for the opening of the Kimal Innovation Centre.

Alongisde an overview of Kimal's history and product range, Mr Javid's was given a tour of the factory - a uniqueopportunity to show the Bromsgrove MP UK manufacturing at its best, and just how far Kimal have progressed from their early pack manufacturing roots in the early 90’s. Mr. Javid was also shown the three class 8 cleanrooms where production takes place to see how Kinal have created a successful supply chain for their own branded products.

The tour completed with the opening of the new Kimal Innovation Centre, the jewel in the crown of Kimal’sincreasing investment in the future of the company through innovation. John Walters, Steve Minett and James Bartlett were on hand to explain to Mr.Javid how Kimal plan to use the innovation centre to expand the company’s knowledge of new technology and manufacturing practices to keep us well ahead of the competition but moreimportantly improve patient outcomes. The team added how important the four InnovateUK grants were to theprogress of Kimal’s projects and its bid to bring new innovative/disruptive technologies to the marketplace.

Alan Press, Kimal CEO, says,“This R&D cell will allow us to bring life to the many ideas and projects we have for advancing healthcare solutions developing countries where access to centralised laboratories and clinics is challenging."

Find out more about Kimal here.

WINTER 2015

BUILDINg A SUSTAINABLE MANUFACTURINg STRATEgY

Product development lifecycles (PDLCs) in the battery industry have shrunk rapidly over the last two decades. It used to be normal for OEMs to deliver a new battery every two years but that is just no longer viable. PDLCs are now typically 12 months and sometimes even shorter. This could be attributed to the convergence of consumer and professional devices - you could call it the Apple expectation or the Samsung effect; it describes the trend over the last few years for multinational consumer electronics giants to move to 12 month cycles.

Transferring these timescales to the medical market, however, poses a slightly bigger challenge. Medicalpractitioners now use their consumer electronics, smartphones, tablets and personal computers in the patientenvironment and are beggining to demand the same characteristics from their professional medical devices.

Medical devices are typically designed for a ten year PDLC, and because a typical Lithium-ion (Li-ion) battery pack is capable of around 400 charge and discharge cycles before its performance drops, these devices use removablebatteries. with the rise of wearable and portable devices however, there is an increasing trend towardsembedded batteries as OEMs can prevent unauthorised repairs, introduce forced upgrades through plannedobsolescence and, because batteries can be embedded with less encapsulation, create even thinner devices.

The pressure on medical OEMs to conform to consumer demand has certainly created a dangerous precedent. Since 2013 the US Food and Drug Administration (FDA) has recalled over 200 products from active use (recalls range from heart-monitoring phone apps crashing during use, to endotracheal tubes detaching during use).

OEMs must be careful of these trends. while it might be ok if your smartphone or tablet loses battery at aninopportune time, it's much more important that your portable ventilator keeps going during surgery.

This customer and OEM push and pull often becomes challenging, especially when it needs to be managed across a wide product portfolio.

Our processes reflect a wider change in manufacturing. when I joined Accutronics four years ago, projectcharacteristics such as quality and flexibility were the highest priority for OEMs, but price has now become much more important. Now, when we form supplier partnerships with our customers, we have to provide the same high quality at a more competitive price point. we have to contend with the fact that high-volume commercial batteries can be price-elastic. This is less true in medical environments, where healthcare customers have a duty of care.

As part of Accutronics' continuous improvement process, we reviewed our manufacturing processes andidentified many improvement actions. Having implemented the most mportant ones over the last two years, we've developed a manufacturing strategy workbook, which consists of five business targets and 12 business processes.

Our five business targets are to deliver new products on time at a competitive price point, maintaining ourrigorous quality, being flexible when it comes to customer requirements and ultimately improving the ease with which customers can do business with us. Each of these targets is broken down further into business processes. we've found that, by using this strategy, we've already been able to make significant efficiency improvements and cost savings and improved our customers' perception of our supplier capability.

I would call on all OEM business leaders to consider a holistic and integrated business strategy, one that is able to adapt to your market and customer needs. In doing so, the best technological innovations can be embraced to build sustainable business growth. It might be the Apple effect, or it might be a combination of factors, butcustomer demands have risen in the electronics industry - it's essential that we stay ahead of the curve.

Subscribe to receive the company’s Blog posts by e-mail - click here.

It will come as a surprise to many people that the UK is currently the 11th largest manufacturing country in the world, just after India. The manufacturing industry contributes £6.7tr to the global economy and it makes up 11 per cent of UK gross Value Added (gVA) output. Despite this, recent innovations in electronics, thin battery technology and design engineering have stumped many business leaders.

Here Prabhjit Singh, production manager at Medilink member Accutronics, looks at how to build a sustainable manufacturing strategy.

WINTER 2015

PUBLIC-PRIVATE PARTNERSHIP LAUNCHES CONSUMER AWARENESS CAMPAIGN IN THEWEST MIDLANDS TO SUPPORTINDEPENDENT LIVINGSupported by Naidex, the UK’s leading event for independent living and disability, the AT Home campaign was launched recently at the National Children and Adult ServicesConference in Bournemouth.

xxxxxxxx - click here.

Linda Sanders, ADASS Lead for Assistive Technology

CHINA–UK RESEARCH AND INNOVATION BRIDGES COMPETITIONInnovate UK, the Research Councils UK (RCUK) and the Ministry of Science and Technology (MoST) for the People's Republic of China are to invest up to £16million in collaborative research and development projects that propose new commercial solutions to critical challengesimpacting the socio-economic growth and development of China in relation toenergy, healthcare, urbanisation and agri-food.

The campaign will use a range of channels and media and will encourage people to think about how independent living and mobility equipment, also known as Assistive Technology, can help people to continue to live independently in a healthy and safe environment at home.

Communications will be aimed at people aged 55+ who are thinking about later life but might not have experienced any major daily living difficulties as yet. Research has consistently confirmed that awareness of Assistive Technology is very low, held back by a combination of factors, including the historical dominance of this sector by the State. A recent study led by Coventry University found that 60% of consumers questioned said that lack of awareness was a barrier to greater use/purchase of Assistive Technology. However the same research also found that 85% felt that the costs ofpurchasing were worth it given that it would make life easier*.

This demonstrates that people are willing to pay, from their own pockets, for products and services, provided that they feel it will help.

This initiative aims to reach people whilst they might still be termed a ‘consumer’, before theirneeds increase and to help prevent them from tipping over to becoming ’a patient’ or service user.

In England almost a third of the population are aged 55+ and an estimated 4.7m people aged 65+have a limiting longstanding illness that affects them in some way, this equates to 48% of allpeople aged 65+**. In many instances Assistive Technology, when used as part of a widerpackage, can help maintain independence,enabling people to live longer in their own familiarhome surroundings, thereby potentially helping to avoid having to consider moving into specialisthousing or a care home in later life.

Click here to visit the website.

*Based upon research conducted as part of Coventry University’s COMODAL project **The estimate is for the England only, based on data from the Institute of Public Care

The UK investment has been made possible through the Department for Business, Innovation and Skills-managed Newton Fund.

FUNDiNg iS for mainly induStrial reSearCh projeCtS.

For UK participants, small or micro businesses couldreceive up to 70% of their eligible project costs, medium-sized businesses 60% and large businesses 50%

• Award: Up to £16 million• Opens: 16 Nov 2015, 00:00• Registration closes: 23 Mar 2016, 12:00• Closes: 30 Mar 2016, 12:00

regisTrATiON is required to enter this competition - click here.

WINTER 2015

EVENTS

MEDILINK EVENTS CALENDAR

T: 0121 452 5630 E: SKILLS@MEDILINKWM.CO.UK W: WWW.MEDILINKUK.COM

MPD Software Vaildation for Medical Devices10 March 2016 I 9.30am-16.00pm I MTIC, B15 3BE

This one day course will focus on the regulatory requirements that surround the software used in Medical Devices and manufacturing environments, touching on how to ensure compliance, with a particular focus on riskmanagement and software lifecycles. You will also explore how ISO 62366, ISO 62304 and ISO 60601 impacts on software processes and review what regulators will be looking for.

Delegate Fee:Members Fee: £250 + VAT

Non-Members Fee: £350 + VAT

March 2016

January 2016

MedilinkWM Medical and Healthcare Business Awards 2015

14 Jan 2016 | 16.00pm-20.00pm | Malmaison B’ham

MedilinkWM invites you to join us for the 2015 Medical and Healthcare Business Awards at Malmaison Birmingham. Featuring a fun-filled, heart-racing activity, a 2 course inspired seasonal meal, before beginning the Awards proceedings, the evening will recognise and celebrate the commercial triumphs of our members.

Delegate Fee:Members Fee: £30 + VAT

Non-Members Fee: £35 + VAT

February 2016

MPD Complying with UDI Regulations andeProcurement Strategy for Medical Device Labelling

21 Jan 2016 I 9.30am-16.00pm I MTIC, B15 3BE

Medilink WM in conjunction with GS1 is offering a discounted one day workshop exploring the UDI regulations for the healthcare supply chain (normal costing of £399.00).

This interactive session will give you the opportunity todiscuss the issues with your industry peers, as well providing the foundations you need for implementation.

Delegate Fee:Members Fee: £250 + VAT

Non-Members Fee: £350 + VAT

MPD ISO 13485 Introduction and Interpretation23 Feb 2016 I 9.30am-16.00pm I MTIC, B15 3BE

MedilinkWM in conjunction with LRQA are able to offer a discounted one day ISO 13485 training course (standard LRQA price: £505.00 + VAT).

The experts at LRQA will be able to guide you through the key requirements for implementing ISO 13485 and explore the key definitions and terminology surrounding the standard, and its relationship with ISO 9001 and 14971.

Delegate Fee:Members Fee: £250 + VAT

Non-Members Fee: £350 + VAT

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SPRINg ACTIVE HAS wON THE INITIATIVE AwARD AT THE 2015 VOCATIONALREHABILITATION AwARDS'The trial aimed to demonstrate the ways in which modern technology can assist in saving both time and money in the provision of health services, as well as providing an early intervention solution for patients. It was conducted in July 2015 for the Spring Active HealthyBack Coach™ service in collaboration with a major U.K. insurer. The service is a digital and physical “virtual” service for the treatment of back pain, which combines digital screening, HealthyBack™ eBook and remote video consultations with a Chartered Physiotherapist.

This proof of concept trial challenged the traditional management of back pain by lone physical interventions. The trial indicates that a digital and physical treatment approach to back pain can increase patient engagement, provide appropriate early intervention and increase resilience and self-management in order to decrease the risk of chronicity to the sufferer.

With this clinical service remote treatment replaces the delivery of face-to-face treatment for relevant patients either completely or partially.

This solution aims to:

- Deliver significant cost saving - Be a fast effective treatment solution - Be patient led and arranged at the convenience of the patient - Establish ‘virtual’ patient and clinician relationship

Clinical follow up calls provide motivation, advice and progress patients’ recovery. This support also replaces the need for further Referral Management as the Spring Active clinician manages the treatment provided to the patient and ensures that the treatment dose is relevant and clinically appropriate to the patient’s recovery.

The trial demonstrated positive outcomes in each of the solution aims; increased patient engagement, providedappropriate early intervention and increased resilience and self management.

The participants of the trial reported reduced pain, increased function capabilities and were able to remain in work during treatment. Spring Active are now engaged in a larger trial of the service to further validate early findings. If you would like to find out more, or be involved please contact our team on info@spring-active.com or 0121 2275281.

Medilink member Spring Active are proud toannounce that they have won the 2015 VocationalRehabilitation Association Initiative Award for their Proof of Concept Trial to Deliver a Digital and Physical Rehabilitation Model to Patients with Back Pain.