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Issue 25 September/October 2015
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Mapping the Irish Med-Tech sector
Med In Ireland – Oct 29 show preview KPMG – sectoral overview
Expo 2016
Manpower for Med-Tech – NEW
www.mtiexpo-uk.com
Young inventors hit the mark
20-21 April Ricoh Arena, Coventry UK
The only major event serving the UK £18bn medical technology industry
Ebola test success
Med-Tech Innovation Contents
Contents ¦ September/October 2015 HOW TO CONTACT THE TEAM
Director – Publishing Colin Martin T: +44 (0)1293 710 042
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E: colin.martin@medtechcomms.com
Content Editor Adrian Lunney T: +44 (0)1293 710 043 E: Adrian.lunney@medtechcomms.com
Send editorial contributions to E: editorial@med-techinnovation.com Design www.rohdeconsulting.co.uk
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35 30 THE HEART OF IT New technology from Philips made a lasting impression at London’s recent ESC congress
Subscription: Med-Tech Innovation is free to qualified readers in the UK and Ireland. Register to receive copies at www.med-techinnovation.com or e-mail: circulation@med-techinnovation.com The Publisher endeavours to collect and include complete and current information in Med-Tech Innovation, but does not warrant that any or all such information is complete, correct or current. The Publisher does not assume and hereby disclaims any liability to any person or entity for any loss or damage caused by errors or omissions of any kind, whether resulting from negligence accident or any other cause. Med-Tech Innovation does not verify any claims or other information appearing in the advertisements contained in the publication and cannot take any responsibility for any losses or other damages incurred by readers in reliance on such content. All submissions are handled with care. Every precaution is taken to ensure accuracy, but the Publisher cannot accept responsibility for the accuracy of the information herein or for any opinion expressed.
32 NORTH EASTERN INDUSTRY XL Precision’s specialist manufacturing expansion continues to win new friends and customers 4
MED IN IRELAND Our exclusive preview of Ireland’s dynamic biennial showcase – in partnership with Enterprise Ireland
24 VITAL DESIGNS Two young award winners show off their lifesaving new products
35 MOVING WITH THE ROYALS We touch base with the Royal Society of Medicine’s regular medical seminar programme 36 CHECKING EBOLA How one UK company is helping turn the tables on the African-based pandemic
26 GOING DUTCH Holland does Manchester – how the collaborative approach to med-tech in the Netherlands is wooing UK buyers
38 PRODUCT SHOTS A taste of some new products on the medtech market
28 GET THE BIG PICTURE KPMG writes exclusively for MTI magazine on global trends in healthcare and in medtech
40 MANPOWER FOR MED-TECH Samantha Blythe-Moore begins her new column on employment and recruitment issues for the med-tech sector
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MedTech Communications Ltd. No part may be reproduced or transmitted in any form without the prior permission of the Publisher. ISSN 2046-5424 Printed at Pensord Press Ltd
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September/October 2015 ¦ 03
Inside the device that healed her heart is our relentless attention to detail.
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Med-Tech Innovation Med In Ireland
Europe’s Med-Tech powerhouse On the eve of Med In Ireland we talk to Brian O’Neill of Enterprise Ireland, organisers of this key biennial event
of the population is under 35 with proven strengths in software and ICT – skills that are in demand as medical devices and technology converges. International visitors point to the advantage that Ireland is a small country which cuts back on travel time and allows for meetings with world-class clinicians, designers, suppliers or customers at opposite ends of the country in the same day.
Q. All of these features come to the fore and are evident at the unique Med In Ireland event. How does the show work?
Dublin's Med In Ireland exhibition venue
Q. For the 2nd year running Ireland is Europe’s fastest growing economy. What role does Ireland’s Med-Tech sector have to play? Ireland is now the 2nd largest exporter of medical devices in the EU after Germany – the sector employs over 25,000 people with exports of €8.5bn annually. Our global market reach is extensive and growing: 30m diabetes patients rely on injectable devices made here; we make a third of the world’s contact lenses; 80% of cardiovascular stents and approximately half of ventilators used in hospitals worldwide are Irish made. This output is carried by over 350 Med-Tech companies, of which 60% are indigenous SMEs. It seems that Enterprise Ireland (EI) and the IDA have made the most of Ireland’s natural advantages when targeting worldwide Med-Tech communities? The Irish Government is incredibly supportive of the sector and strong linkages between the clinician community and industry have been fostered through supports such as the Health Research Board Clinical Research Co-Ordination Ireland (HRB CRCI) network, the BioInnovate programme and the National Health Innovation Hub. The sector is also supported by new infrastructure in the form of technology centres such as ARCH (Applied Research for Connected Health), an EI/ IDA funded centre for connected health research. We also have a young and innovative workforce: 49%
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A. Med in Ireland is an invite only event. Guests are selected and invited by EI’s network of 32 international offices, based on their relevance to exhibitors. We provide an online matching service for setting up one-toone meetings and an opportunity for guests to undertake site visits to exhibitors’ facilities. We also feature key note industry speakers – this year from J & J, Medtronic, Sorin and Jefferson University and Jefferson Healthcare System. These presentations are a major draw for both exhibitors and guests. The entire ecosystem is on display from leading academic systems through to clinicians, VCs, banks and world-class ancillary service providers to the industry. The overriding priority however is the one-to-one meetings between exhibitors and guests. We measure success on the number of business leads, contracts and strategic partnerships that result from this important sectoral event.
Q. And the UK market is also a key part of this matchmaking - including customers such as the National Health Service (NHS)? Ireland and Britain trade over €1bn worth of goods every week. Ireland is the 5th largest export market for the UK, and Irish Life Science sales to UK last year were up 27% on 2013. As a publicly funded healthcare system, the NHS operates within tight budget constraints and looks for innovative products that provide efficiencies - this is why Enterprise Ireland clients are winning business with the NHS. September/October 2015 ¦ 5
Med-Tech Innovation Med In Ireland
IMDA stands tall The Irish Medical Device Association (IMDA) will be in attendance at Med In Ireland on Oct 29th.
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key activity of the IMDA is the Irish Medtech Excellence Awards 2015. Now entering its ninth year, the awards are open to any med-tech company based in Ireland. Previous winners include: Aerogen, Lake Region Medical and Cook Medical, with last year’s winners Nypro Healthcare being recognised for innovation as well as for business development, with expansions in Bray and a state-of-the-art facility in Waterford adding 200 jobs. The three award categories are: Medtech Company of the Year; Emerging Medtech Company of the Year; and Academic Contribution to Medtech. IMDA Director Sinead Keogh says that ‘the 2015 Medtech Awards will showcase the diverse strengths of the industry, which promotes patient care by driving innovations with as many as 75% of replacement joints for knees and 80% of the world’s stents developed here. IDA Ireland Head of Medical Technologies, Michael Lohan, says ‘the Irish med-tech sector continues to grow; more than €652 million in investment has been announced in Ireland since 2014. Ireland is home to 18 of the world’s top 25 companies and the IDA continues to work to make Ireland one of the most attractive places in the world to do business.’
Pictured launching the Irish Medtech Excellence Awards 2015 are: Enterprise Ireland Senior Development Advisor, Life Sciences Department, John Shiel; IDA Ireland Head of Medical Technologies, Michael Lohan; Irish Medical Device Association (IMDA) Director, Sinead Keogh; and Nypro Healthcare Director, Device Development (Europe), Derek Fenlon.
Creagh business balloons Galway-based Creagh Medical will put its balloon catheter expertise to the fore at the Med In Ireland show. Founded in 2006, Creagh has grown through the development and commercialization of multiple Peripheral Vascular product platforms that are now being sold to customers worldwide. The company’s flagship offering is PTA (percutaneous transluminal angioplasty) balloon catheters. The products range from .014” to .035” wire platforms for all kinds of clinical applications. In addition to PTA Creagh products – all made under one roof - are used for stent delivery, drug coating, aortic moulding, embolization, vertebralplasty, sinuplasty, and urinary applications. Creagh supplies over 10 product platforms worldwide today, with plans for significant growth in the coming three years. Creagh now has global reach with regulatory approvals and commercial sales in the EU, US, Japan, China, Australia, Canada, Brazil, and other Asian and Middle East countries. Creagh is happy to have positive judgement of its products from enduser physicians and doctors. And, the ultimate judgement of that quality lies with the end user. Dr’s John Ross and Sanford Altman, based in Florida and South Carolina respectively, are two such. They are two prominent US interventionists, specializing in the treatment of A-V fistulae utilizing a new high pressure Creagh product, distributed by DirectAccess Medical, called the FirstChoice Balloon Catheter. FirstChoice was designed by Creagh specifically for the treatment of these often difficult to dilate fistulae. In the hands of Dr’s Ross and Altman, and many more US physicians, this product has proven to be highly effective, delivering the quality, safety and performance needed from today’s balloon catheters. 6 ¦ September/October 2015
Enterprise Ireland Senior Development Advisor Life Sciences Department John Shiel, says: “Irish Medtech start-ups continue to demonstrate their ability to bring innovative products to a very demanding global market. These awards are open to companies of all sizes, and recognise emerging companies for their unique contribution to a growing sector, which announced over 1,300 new jobs in 2014 alone.’ The Irish Medtech Excellence Awards ceremony will take place in the Clontarf Castle Hotel, on Thursday 10 December 2015. The awards are sponsored by KPMG, Teleflex, SteriPack, AIB and IMDA Skillnet. For more information, please visit www.imda.ie/awards (Please see page 18-19 for IMDA’s infographic of med-tech in Ireland)
Creganna expands Galway-based Creganna Medical is looking forward to showcasing its recently acquired wire and coil capabilities during the Med in Ireland exhibition. Specializing in wire-based delivery systems, guidewires, components and tooling, Creganna Medical counts itself as a leading supplier of wire and coil products for cardiovascular and neurovascular device applications. Creganna Medical will also be exhibiting its unique SmartForm™ balloon-forming technology at Med in Ireland. This proprietary technology enables new levels of complexity and customisation in medical balloon design and manufacturing. Applications include balloons for coronary & peripheral vascular angioplasty, valvuloplasty, sinuplasty, occlusion, ablation and sizing. Creganna Medical serves 400 customers in 30 countries across the world, and is a leading provider of catheter solutions, offering a range of technologies, including metal shafts, hypotubes, wires, coils braided shafts, extrusions, balloon & molding services.
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Med-Tech Innovation Med In Ireland
Factory 4.0 – the Irish Med-Tech future A unique and collaborative med-tech project is underway in Ireland. It involves several Med In Ireland exhibitors such as Vistamed, Irish Micro Mouldings, TEG, Trend Technologies, Steripack and others.
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he project centres on Cook Ireland in Limerick. It includes that company’s SME and Irish based supply chain and also embraces well known international OEM names and customers with manufacturing plants in Ireland. Over the next 12 months companies such as Asystec, Entellexi, Johnson & Johnson, Boston Scientific and Goodman Medical Ireland will all play their part in the activities. The 1 million euro initiative is being coordinated by Andrew Lynch, Chief Innovation Officer at the recently formed Irish Manufacturing Research Centre. The new med-tech based programme will examine and optimise relationships and efficiencies in Ireland’s med-tech supply chain. The project will also educate and catalyse the understanding and application of the upcoming and global mart/intelligent factory revolution. This is sometimes referred to as Industry 4.0, Factory 4.0, or Smart Factory (in the USA). The project members will have the opportunity to be on the leading edge of future factory developments. The work will centre on the production of a moulded stent fitting at Cook Ireland. Supply chain contributors will include Irish firms in design, tooling, materials, packaging, sterilisation and other med-tech functions and disciplines. Andrew Lynch points out that ‘our newly launched project contains benefits and learnings at many levels throughout the entire supply chain. Industry 4.0 is still new territory for global manufacturing – and Irish industry intends to be on the leading edge from the get-go. The purpose of our pilot project is to develop a model of engagement which is suitable for industry needs, delivers real impact to manufacturing sites right now and also helps roadmap further initiatives in the area of advanced manufacturing into the future.’ Lynch adds that ‘the Factory 4.0 initiative is very well suited to the Irish med-tech manufacturing space. It also complements the strategy and resources already provided by the IDA and Enterprise Ireland in relation to start-up funding, academic research of relevance to medical devices, competitiveness supports for manufacturing companies and building exporting capability.’ The pan-company approach also will also benefit from the involvement of international and Irish-located customers such as Boston Scientific, Intel, Mergon International, Trend Technologies, and Goodman Medical. www.med-techinnovation.com
Andrew Lynch (centre, white shirt) at a co-ordinating project meeting
‘We are very fortunate to have such multinationals at hand and willing to help nurture a thriving sub-supplier base, working with Irish SME manufacturers to ensure that they remain competitive, innovative and a world class resource.’ Lynch also points out that this pilot programme represents a very small part of a future investment in Irish manufacturing. ‘Collaboration and partnership is key,’ he notes, ‘not only between our large group of industrial partners but also in relation to the government agencies who are helping formulate this approach.’ The initiative also has partners and providers beyond Ireland’s shores. Lynch notes that ‘we have, for example, secured support from two Fraunhofer Institutes (IML and IPT) on matters of supply line integration and process automation. We also have strategic partners in the additive manufacturing field with Stratasys and EOS coming to the fore; and the project is also liaising with the UK’s Manufacturing Technology Centre and with the MADE research institute in Denmark..
September/October 2015 ¦ 7
Med-Tech Innovation Med In Ireland
SteriPack – adding value
SteriPack was founded in Clara, Offaly in 1994. We talk to Barry Moore, sales director about the development of the company and its presence at Med In Ireland 2015.
How did SteriPack come about? Was there any founding vision or driving theme in starting the business? My brother Garry had worked in the Industry in the US and Ireland and felt there was a gap in the market. Around this time Ireland was developing as a major hub for Medical Device Manufacturers. CR Bard (now Medtronic) and Boston Scientific were growing and looking for local suppliers so we fitted right in. The key investment in the beginning came from the Smurfit Job creation fund. This was seed capital to allow us to invest in critical equipment to manufacture quality products. By using wide web machines we were able to compete economically in the developed market. This also allowed us to use master rolls from our suppliers and again this helped keep our costs down. Lean Manufacturing techniques meant quick changeovers line clearances.
What factors helped the company’s development? Small batches and hand deliveries were par for the course. Being in Clara we were usually within 2 hours of customers. A reactive supply chain was also essential to our success in meeting the demands. We have worked with Holfeld Graphics and Rotometrics for tooling from the beginning. A quick turnaround in cutting dies, sealing dies and print plates made tight deadlines possible. Early in our development we saw an opportunity to provide added-value services and this became a strong part of our business.
And Enterprise Ireland was at hand to help? From the start Enterprise Ireland offered fantastic support in getting to know our export markets and then how to infiltrate them.
What value does Steripack find in the Med In Ireland show? It’s always a great audience with high level networking opportunities. In fact the Med In Ireland show has brought our own business networking up to the next level. The event is now one of SteriPack’s key exhibitions as the audience is perfectly targeted in our market.
What is Steripack showing at Med In Ireland Oct 29th? SteriPack will be showing our developments in package testing in our Laboratory. We have invested in a range of new equipment to provide the latest testing facility certified to ISO 17025 in the country. We will field an experienced team of engineers at the show – to assist customers in planning their testing and to allow them to launch their products successfully in the marketplace.
Which buyers would benefit most from a visit to the Steripack stand and for what reasons? We have a range of new vent packaging that can reduce package cost by up 50% and still allow our customers to Eto or gamma sterilise their product.
How has growth affected Steripack’s development? EBR (Electronic Batch Records) has rolled out over the past 5 years and is eliminating paperwork from our process. This gives us both a technical advancement in information recording / access and also meets an environmental requirement to reduce paper use in the process. Having sites in 4 countries and in three continents has its challenges. We have accordingly created positions that coordinate between the facilities to ensure we are not reinventing wheels and that each site is aware of the improvements that other sites are making. A full version of this interview with Barry is published online at http://www.med-techinnovation.com 8 ¦ September/October 2015
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Med-Tech Innovation
Medical Packaging
Custom packaging solutions that provide superior quality and protection
www.nelipak.com | info@nelipak.com
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Packag Cleanroom Thermofor Packaging Validation Total Packaging Solutions Tray Heat Sealing Machines
USA - The Netherlands - Ireland - Costa Rica
September/October 2015 ÂŚ 9
Med-Tech Innovation Med In Ireland
Dolmen to share its design experience
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usiness development consultant with creative design and innovation consultancy, Dolmen, Frances Mitchell says: ‘Med In Ireland is a key event in the Dolmen calendar. We have exhibited at the show since its inception, and the exemplary work done by Enterprise Ireland and the IDA together with the med-tech industry means that the quality of attendees is always extremely high.’ Dolmen is pretty fired up about this year’s exhibition. ‘Not only will we present examples of the work we have done with our national and international clients,’ says Mitchell, ‘we have also partnered with Irish Design 2015 to develop a showcase of Irish Design and Medical Technology. This explores the value that the design process and design thinking brings to the sector and will related projects from a number of Irish med-tech players. Dolmen CEO, Sean McNulty, will also give a workshop during the morning session, demonstrating the company’s Discovery process and how it adds value to clients, helping them better understand the unmet, undermet and unarticulated needs of end users – and then developing outcomes that result in impactful designs. 2015 has been good thus far for Dolmen. Alongside new patents granted, the company has won 2 Red Dot
Sean McNulty, Dolmen CEO
design awards, as well as the IDI Grand Prix. One of its product designs was shortlisted for Designs of the Year in the London Design Museum (currently on display). The Dolmen team of Sean McNulty, Martin Bruggeman and Frances Mitchell will be there for the full day and will be looking to meet companies at Med In Ireland who are looking to develop products that will leapfrog competitors and cause market disruption.
Frances Mitchell – Business Development Consultant, Dolmen
Power – and peace of mind
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eadquartered in Little Island, Cork, Excelsys Technologies is looking forward to the Med In Ireland show, both to launch new products and to meet customers, old and new. Such customers - including GE Healthcare, Siemens Medical, Philips Medical, Alma Lasers, Syneron and Draeger - have selected Excelsys power supplies for their applications, which encompass Medical Imaging (MRI, CT, X-ray, Ultrasound), Medical Lasers (Surgical and Aesthetic) and Diagnostic Equipment (clinical and laboratory). Sales director Dermot Flynn says that ‘the market for power supplies used in medical applications is complex. The wide variety of medical equipment products from low power infusion pumps, up to medical lasers and 10 ¦ September/October 2015
MRI equipment, each have various (often custom) power requirements, as well as differing standards relating to the medical market. Furthermore, medical system designers also face the challenges of reducing the time to market and cost, whilst maintaining the highest levels of reliability and ensuring patient safety at all times.’ Flynn says that ‘over 50% of Excelsys’ business is in the Medical and Laboratory sector. It is also the fastest growing market segment for our product.’ Excelsys offers its customers the only 5 year Warranty in the medical power supply industry, guaranteeing peace of mind for system designers. And the unique ‘Plug-and-Play’ architecture of the UltiMod system from Excelsys brings great product flexibility, allowing customers to meet all of their ‘customised’ requirements from a standard product. Flynn says of Med In Ireland that ‘the focused nature of the event affords us a unique opportunity to present our products and also network with the leading medical technology companies in the world. www.med-techinnovation.com
Med-Tech Innovation Med in Ireland
Aerogen for the world
A John Power, CEO, Aerogen
Aerogen was ‘born global’ and its worldwide business savvy will be to the fore in Dublin on October 29th.
erogen’s successful strategy of securing integrating partnerships (‘Aerogen inside’) with the leading MNC ventilator companies such as GEHealthcare, Philips, Covidien and Maquet has created a low-outlay global footprint for its products. This export-led growth continues and in the last 18 months the company has targetted its efforts on high potential countries – United States, Germany, France,
New from Proxy Galway based Proxy Biomedical will bring its Bio-XT technology to the Med In Ireland show. This is a reinforcing technology that can enable stronger, more porous, and lower profile resorbable implants to support performance and clinical outcome improvements in next generation products. Proxy Biomedical also uses a range of advanced conversion processing techniques to apply biomaterial coverings to vascular implants. With vascular intervention evolving at a dynamic pace, invasive open surgical approaches are being avoided in favor of transcatheter intervention and minimally invasive implant delivery. In order to treat a greater range of indications, metal based vascular implants are being integrated with an increasingly diverse range of biomaterials. Textile covered endovascular grafts, pericardium valves for aortic valve replacement and PTFE covered stents, are just some of the biomaterials growing in prominence within vascular minimally invasive intervention. Proxy Biomedical’s conversion processes integrate diverse polymeric biomaterials onto implants, including resorbables and functional coatings, to enable a broad range of functions, including occlusion, filtration, flow diversion, inhibiting restenosis, containing tumour growth, maintaining vessel integrity or supporting heart function. The application of these devices has now evolved beyond traditional coronary and peripheral indications to include endovascular, structural heart, neurovascular, carotid, below the ankle and even venous indications. These devices are also fulfilling solutions outside of vascular, including pulmonary, gastro-intestinal and urinary indications. www.med-techinnovation.com
UK & Ireland, and China. The ranking of Tier 1 countries was based on a combination of healthcare market-size, existing business and potential for growth. The execution of the strategy involved investing in people, increasing the US presence by 50%, along with strategic hires in Germany, France, China and UK & Ireland. In addition, the company developed strategic insights, including hospital/customer profiling and segmentation to enable greater targeting and penetration of the healthcare sectors. The company supported and developed the independent distributor network in Tier 1 countries, ensuring that they understood the importance of their role in the achievement of Aerogen, and their own success. The results of this strategic approach is evident. The US has seen a 35% growth despite continuous and growing market challenges. Aerogen is now the standard of care in paediatric and neonatal intensive care units in the US, with a circa 30% market share in adult intensive care. In Europe, France has seen Aerogen develop strategic relationships as the only aerosol drug delivery system in the three main university hospitals in Paris, Lyon and Marseille. Aerogen has developed strategic allegiances with the two largest Group Purchasing Organisations in Germany for the supply of Aerogen products to the top hospitals in the country, the results of which has been an 87% growth in revenue. In China, the last 18 months have focused on developing the base, as well as progressing with Chinese registration of the flagship product, the Aerogen Solo. Aerogen will launch 3 new products in China in 2016.
Ash Technologies Ltd is looking forward to promoting its electronic magnification solutions to the Med In Ireland audience. 90% of Ash products are exported through an international distribution network. The company offers two key inspection portfolios: Video Inspection Systems for increased efficiency with measurement and inspection OEM & ODM Video Inspection Systems for resale and custom solutions The company’s Inspex HD 1080p is an ergonomic desktop inspection system/digital microscope. It reduces neck and eye strain for the operator, therefore increasing productivity and reducing fatigue. Some of the key features include integrated LED lighting and integrated dimensioning grids and cursors.
September/October 2015 ¦ 11
T E C H N O LO G Y
Med-Tech Innovation Med In Ireland
A young partnership launches The Med In Ireland show plays host to a unique product partnership based on the skill and innovation of two leading exhibitors – Incereb and System Label.
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oth are involved in the launch of the NEON12 and NEON8 EEG devices. These are Incereb’s first products, and allow the application of multiple EEG sensors to preterm infants (neonates) in less than a few minutes. Incereb was founded in 2012 by a team with over 20 years’ experience in clinical neurophysiology and medical device development. The company designs and develops disposable physiological monitoring sensors, including Electroencephalography (EEG) and Cerebral Function Monitoring (CFM) for use in The Neonatal Intensive Care Unit (NICU) on term and preterm infants (neonates). System Label’s team worked alongside Incereb to manufacture the end product. Utilizing flexible print intelligence, System Label’s expertise in screen-printing conductive and dielectric inks proved invaluable in producing a circuit for monitoring brain activity. Jim Roche, Incereb CEO says that ‘we are delighted to be attending Med In Ireland alongside our supplier partner. The event is the premium showcase event for medical device companies in Ireland, and ideal for a new company like ourselves to get the opportunity to reach an international network of medical device professionals and clinicians. Niall O’Shea, Managing Director of System Label, notes that ‘we are likewise delighted. The show provides us with the platform to showcase our capabilities to the international med-tech industry. Through meeting high profile clients, we aim to develop strategic partnerships and build our business globally as the preferred label www.med-techinnovation.com
The NEON EEG devices provide a new standard in monitoring and care for preterm infants
Niall O’Shea, System Label (left) and Jim Roche, Incereb, put the fine tuning to preparations for the Med In Ireland exhibition
supplier to the medical industry’. Roche adds that ‘having secured our first European distribution distribution partners, we are keen to develop further distribution contacts in Europe and The Middle East. We believe Incereb’s NEON EEG device is the perfect for the highly developed Neonatal Intensive Care Markets in these countries.’ The NEON products certainly have a bright future ahead. Traditional methods of neonatal EEG sensor application often take far longer, are often technically very difficult and can also involve the use of subdermal needles to save time. Application of the NEON devices requires minimal training, is non-invasive, has universal connectivity to all brands of monitoring equipment, and is single use. The foam sensor pad is a unique device that supersedes all other products in the market and has a potential worldwide market for 3.6 million units per annum. Roche comments that ‘it was crucial to the success of the product that we found a supplier with the technical expertise and knowledge we could trust to bring this project to market. As a young company, it was essential that we had a responsive manufacturing partner who worked with us as we scaled up manufacturing from prototyping to larger volumes.’ Incereb selected System Label as their Strategic Supply Partner primarily for its expertise and resources in the area of materials, inks and adhesives. The NEON EEG has many layers and required flexibility and durability as the end result. The System Label team were also able to prescribe the right combinations of inks, materials and adhesives in order to avoid contamination. Early involvement in the design phase allowed System Label to manufacture the intricate product to the highest med-tech standards. The foam sensor pad was produced in separate stages and included a number of technical processes. September/October 2015 ¦ 13
Med-Tech Innovation Med In Ireland
DON’T MISS ‘IT’… By Ronan Maher – Anecto Marketing
The hero of 1980’s teen movie Ferris Bueller’s Day Off once famously said: ‘Life moves pretty fast. If you don’t stop and look around for a while, you could miss it.’
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nd when it comes to compliance within the medical device industry you simply can’t afford to take days off like Ferris did. Missing ’it’ could be very important. Staying abreast of the latest regulations is a constant challenge and usually leaves companies with two choices: do it yourself or get someone to do it for you. As an independent ISO17025 accredited test laboratory, Anecto Ltd. is your ideal partner for the latter, since our service offerings include consultancy on regulatory compliance in medical devices and medical device packaging. Whichever course you sail however, two important challenges lie ahead - the FDA’s latest Unique Device Identifier (UDI) compliance deadline and DuPont’s Tyvek Transition. The UDI is the FDA’s way of standardising labelling for all new medical devices. The compliance date deadline for the latest part of the UDI requirements is Thursday 24 September 2015 and a raft of requirements in the marketing and labelling areas will be mandatory. (More information is available on the FDA website.) The Tyvek Transition is scheduled for completion in
Zeus innovates Donegal-based Zeus will use Med In Ireland to exhibit the full range of products and to further promote its FluoroPEELZ™ product, a new peelable heat shrink solution. FluoroPEELZ™ offers medical catheter manufacturers a new method to increase yield and improve safety. Zeus has launched the product with a ‘Peel it off. Peel it ALL off’ campaign. Catheter construction is a delicate process that leaves no room for error. The last step of removing the recovered heat shrink from the outer shaft is often the most critical and laborious. With FluoroPEELZ™, one simple linear tear is all it takes, according to Zeus. ‘FluoroPEELZ represents the most significant product enhancement for catheter construction available in years,’ 14 ¦ September/October 2015
2015. Anecto has carried out a good deal of testing for DuPont as part of the Tyvek Transition Project. The aim of the project is to meet a growing global demand for Tyvek and ‘to ensure continuity and flexibility of future supply’, by transitioning Tyvek® 1073B and Tyvek® 1059B to a higher yield manufacturing process, utilising what is known as flash-spinning. A thorough guide through DuPont’s Tyvek Transition progress can be found on the DuPont website. And visit the Anecto booth at the show for consultation on these matters. It’s always difficult to sail the ever-changing sea of medical device compliance. However, stay vigilant, entrust the work to the right hands and you’ll keep your head above water. Just don’t take a day off. Leave that to irresponsible 80’s movie characters.
says Irina Roof, PhD, staff material scientist at Zeus. ‘By keeping workers safe, reducing scrap and improving efficiencies, it’s the solution manufacturers charged with reducing costs, increasing yield and improving work place safety have been looking for.’ Zeus believes that the product offers the highest optical clarity on the market, allowing operators to visually inspect the construction during the reflow process. This eliminates guesswork and speeds the production process. In addition, Zeus says that the product offers superior reflow ability. Once removed, FluoroPEELZ™ produces a smooth void-free exterior finish.
Exhibitor EC Labels was established in Waterford in 1992 by Mr. Eamonn Coonagh. The business is still family-run, and prints and supplies packaging films for food, pharmaceutical and retail applications. Packaging applications include - Special Sizes, Internal Cuts, Perforations, Reverse Printing, De-laminating, Sprocket-Fed Labels, Security Inks & Varnishes, Barcoding and Back-Numbering for stock control. Full colour-matching, and a die list of over 1200 cutters is also available.
www.med-techinnovation.com
Med-Tech Innovation Med In Ireland
Good cheer from Sláinte Healthcare Exhibitor Sláinte Healthcare arrives at the Med In Ireland show in good heart, fresh from its multi-million euro deal with Beacon Hospital, which will see the latter become Ireland’s first digital, paperless hospital within 18 months.
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láinte Healthcare is currently installing its electronic medical record software, Vitro in the hospital, enabling staff to manage its 100,000 patients per annum electronically. Andrew Murphy, CEO Sláinte Healthcare, says that ‘electronic medical records are something that healthcare facilities throughout the world have struggled with. However, our Vitro story continues to grow. Our two core products, ‘Claimsure’ and ‘Vitro’ are in use by 51 public and private hospitals in Ireland and throughout healthcare organisations and hospitals throughout the world, with major new contracts across public and private facilities, including Australia, UAE and globally through the charity Operation Smile, now using VITRO as its Electronic Medical Record (EMR) system across 56 countries.’ Established in 2006, Sláinte Healthcare claims to be
Ireland’s fastest growing healthcare technology company, having grown by over 1500% in the last five years. Headquartered in Sandyford in Dublin, the company employs over 130 people across its offices in Ireland, the Middle East, Australia and the UK. Andrew Murphy (left), CEO of Sláinte Healthcare and Michael Cullen, CEO of Beacon Hospital, celebrate the forthcoming end to paper records at the hospital
Advant Medical teams with CRI Advant Medical exhibits at Med In Ireland, hot on the heels of a strategic alliance with CRI, expanding capabilities to include balloon development and catheter manufacturing. The company has recently included injection moulding and additive manufacturing in its manufacturing portfolio. This latest development is set to further the company’s capabilities across the medical device industry and will now providing a strategic route to European and Asian Markets for both parties. Bob DiPetrillo, CEO, Advant Medical, says that ‘aligning Advant with CRI will provide another level of expertise to the Advant Medical Corporation. The combined expertise of Advant and CRI will also position both corporations for growth and expansion.’ Phil Sheingold, CEO, CRI says that ‘a strategic alliance with Advant expands our balloon and contract manufacturing footprint within Europe and leverages the engineering services, design & development, and customer service offerings of both companies globally.’ CRI is a global full service medical device manufacturer, specialising in class I, II and III single-use medical devices, concept development and product life cycle management. The CRI team has released over 10,000 medical balloon designs for specialty applications. These include neural, ENT, coronary, CTO, predilatation, stent delivery, structural heart, renal, prostate and lower limb salvage. www.med-techinnovation.com
Synecco will be showing a full range of its services at Med In Ireland. The company is a full service design and contract manufacture business, specialising in single-use medical devices and the systems that support them. The core services include design & development, prototyping & tooling, molding & extrusion, electronics integrations, assembly & packaging and, sterilisation. Synecco specialties include low to medium volume production of: så å3INGLE USEåMEDICALåDEVICES åCATHETERS åmåUIDåSETS å technical mouldings & devices and dispensing systems. så å-ECHANICALåANDåELECTRONICåSYSTEMSåTHATåSUPPORTåTHEå development and deployment of such devices The company is looking forward to meeting with a variety of buyers and customers at the Med In Ireland show. These include development, manufacturing and non-manufacturing organisations, to which Synecco offers a complete end-to-end design, development, production and supply chain service.
September/October 2015 ¦ 15
Med-Tech Innovation Med In Ireland
S3 Group joins the healthcare dots... Diarmud Quinn, business development manager S3 Group is a man on a mission.
T
he issue is connected health. ‘Medical device vendors are faced with a challenge,’ he says. ‘The sector operates in a highly regulated environment with long product life-cycles. In these circumstances, how can medical device vendors respond to the rapidly evolving opportunity presented by connected health? How can a medical device that is developed in 2015/2016 hope to be relevant in a connected environment in 2020?’ The S3 Group, headquartered in Dublin, is in business to provide answers. The company was recently honoured by Merck Serono, the biopharmaceutical business of Merck, when it was announced that MSdialog, the company’s digital-tracking software for people living with MS, has been chosen as the winner of this year’s Medical
Design Excellence Awards (MDEA) Readers’ Choice Award. The S3 Group as design partner, played an important role in the design and delivery of MSdialog, which has given thousands of MS patients an efficient way to monitor their treatment adherence, track symptoms and improve the quality of conversations during visits with their HCPs. MSdialog is a multi-tenant cloud-based software system for the management of MS that captures and presents patient outcome data to enable better decisionmaking by patients and providers and is now available in 31 countries. Diarmud Quinn invites all at the Med In Ireland show to visit with S3 Group to discuss connected health issues and the future proofing of their products.
A good clean show
A
good number of Med In Ireland exhibitors will be offering products and services in the disinfection and washing areas. Wexford-based Medentech, for example, is a 30 year-old medical disinfection company, now exporting to over 120 countries. It began life with the development of a fast acting and effective effervescent tablet, Sterinova, as a portable, easy to use disinfection solution for infant feeding bottles. The company is now the world’s number one in two separate product sectors and holds GMP, ISO 13485 and many other accreditations, providing surface disinfection tablets and liquid disinfectants for endoscopes, medical devices & skin as well as ultrasound gels.
16 ¦ September/October 2015
In addition to Sterinova, the point of use surface segment includes a range of specialist products for niche applications, such as Inovotabs, Aquasept, and Agrisept. In 1989, following a successful MBO, the Company became private and in 1997 the Company relocated to its current purpose built, state of the art, headquarter building in Wexford Ireland. Exhibitor SureWash uses video gaming type technology to deliver hand hygiene training, focusing on the hand hygiene technique as recommended by WHO/ CDC. SureWash is a mobile unit, which can be rotated around the hospital, encouraging staff to train and have their technique assessed by the system while providing a full range of reports for management requirements. Using a card reader to capture staff details, reports are generated easily which can, if required, be integrated with existing hospital training record systems. SureWash also provides multiple choice questionnaire functionality which is available on the system itself and can also be accessed through the SureWash app on mobile devices. Limerick-based i360hygiene is a medical technology company focused on reducing Healthcare Associated Infections (“HCAIs”) by ensuring that healthcare workers wash their hands. Tommy O’Sullivan, Heat of Project Management says that ‘i360hygiene has a simple USP; we make it easy for healthcare workers to be compliant – and our hand hygiene solutions increase hand-washing compliance'. www.med-techinnovation.com
Med-Tech Innovation
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Medical Device Development and Manufacturing Solutions ADDITIVE MANUFACTURING RAPID PROTOTYPING INJECTION MOULDING PRODUCT DEVELOPMENT CONTRACT MANUFACTURING CONTRACT PACKAGING E-mail:Â info@advantmedical.com Tel.:Â +353 (0) 91 770777 #FXCPV /GFKECN .KOKVGF 2CTMOQTG $WUKPGUU 2CTM 9GUV )CNYC[ a+TGNCPF www.advantmedical.com ' OCKN aKPHQ"CFXCPVOGFKECN EQO 6GN a www.med-techinnovation.com
September/October 2015 ¦ 17
Med-Tech Innovation Med in Ireland
CREATED BY
The Irish Medical Device Association (IMDA) is the Ibec group that represents the medical technology industry in Ireland.
West Region CONNECTED HEALTH 1 Emedia 2 Full Health Medical 3 Socrates Healthcare Ltd 4 SyncroPhi Systems Ltd 5 VASGARD CONTRACT RESEARCH, DEVELOPMENT, DESIGN AND/OR MANUFACTURING 6 Advant Medical 7 Advant Moulding 8 Alpha Precision 9 Amcor Flexibles Sligo 10 Arrotek Medical 11 Avenue Mould Solutions Ltd 12 Cambus Medical 13 Caragh Precision 14 Clada Medical Devices 15 Creganna-Tactx Medical 16 Custom Equipment Solutions Ltd 17 Dawnlough Ltd 18 DiaNia Technologies Ltd 19 Fort Wayne Metals Ireland Ltd 20 Galway Tool And Mould Ltd 21 Harmac Medical Products 22 iNBLEX Plastics 23 Irish Micro Mouldings Ltd 24 Lake Region Medical 25 Lake Region Medical (International Research & Development Centre) 26 M & M Qualtech Ltd 27 MB Mediprint 28 Metal Improvement Company 29 Outsource Technical Concepts Ltd 30 ProTek Medical Ltd 31 Riteway Precision Engineering Ltd 32 Synecco Ltd 33 Vention Medical Ireland Ltd 34 Verus Precision 35 VistaMed 36 Vornia Ltd DIAGNOSTIC 37 Abbott Ireland Diagnostic Division 38 Alere International Ltd 39 Beckman Coulter Biomedical 40 Fannin Ltd 41 Natus Maufacturing Ltd HOSPITAL AND/OR HOMECARE PRODUCTS 42 Abbott Ireland 43 Abbott Nutrition Ltd 44 Aerogen Ltd 45 AeroSurgical Ltd 46 AOTI 47 B.Braun Hospicare Ltd 48 Baxter Healthcare SA 49 Baxter Healthcare SA 50 Bio Medical Research Ltd 51 Covidien 52 Crospon Ltd 53 Envaste Ltd 54 Janisys Ltd 55 Hollister ULC 56 Hospira 57 Idoman Teoranta 58 Lifewave Europe 59 Mylan Teoranta 60 Pointec Medical 61 Proxy Biomedical Ltd 62 Vysera Biomedical Ltd OPHTHALMIC 63 Abbott Medical Optics 64 Allergan 65 Transitions Optical Ltd ORTHOPAEDIC 66 APOS Ltd SERVICE 67 Anecto Ltd 68 Areneco 69 Charles River Laboratories Preclinical Services Ireland Ltd 70 CLS Medpharma 71 Embricon Ltd 72 KPW Print 73 Sealed Air Nelipak
18 ¦ September/October 2015
74 75 76
Specialised Sterile Environments (SSE) Synergy Health Ireland Ltd Volex Europe
VASCULAR 77 Apica Cardiovascular 78 ArraVasc Ltd 79 Boston Scientific Galway 80 CareFusion Manufacturing 81 Creagh Medical Ltd 82 Delcath Systems Inc 83 Embo Medical 84 Goodman Medical Ireland 85 Marvao Medical Devices 86 Medtronic 87 Merit Medical Ireland Ltd 88 Neuravi 89 Vascular Solutions Zerusa Ltd 90 Veryan Medical Ltd 91 Vivasure Medical Ltd
North Region CONTRACT RESEARCH, DEVELOPMENT, DESIGN AND/OR MANUFACTURING 92 Moll Industries Ireland Ltd 93 Phillips-Medisize Ireland 94 Zeus Industrial Products (Ireland) Ltd DIAGNOSTIC 95 Abbott Diabetes Care Donegal HOSPITAL AND/OR HOMECARE PRODUCTS 96 Abbott Ireland Nutrition Division SERVICE 97 Perfecseal Inc 98 Randox Teoranta
South Region CONNECTED HEALTH 99 Advanced Manufacturing Control Systems (AMCS) 100 BodyTab Ltd 101 CliniSynergy Ltd 102 Doctot 103 Epic Solutions Ltd 104 Independent Data Management Ltd 105 Lincor Solutions Ltd 106 Portable Medical Technology Ltd 107 Rigney Dolphin Ltd CONTRACT RESEARCH, DEVELOPMENT, DESIGN AND/OR MANUFACTURING 108 APS Materials 109 Croom Precision Medical Ltd 110 Designwise Automation Ltd 111 FastForm Research Ltd 112 Filtertek BV 113 Firebird Medical Ltd 114 Gentian Services Ltd 115 Hi-Life Tools 116 Listal Ltd 117 Merck Millipore Ireland Ltd 118 MTD Precision Engineering Ltd 119 Nypro Healthcare Waterford 120 Phardiag 121 RR Donnelley 122 Sanmina 123 Schivo Precision Ltd 124 Shannon MicroCoil Ltd 125 Smart Electronics Ltd 126 Smithstown Light Engineering Ltd 127 Takumi Precision 128 Teleflex Medical DIAGNOSTIC 129 Audit Diagnostics 130 Beckman Coulter Ireland Inc 131 Crescent Diagnostics 132 Neonatal Diagnostics 133 Radisens Diagnostics 134 Raman Diagnostics 135 Roche Ireland Ltd 136 SensL Technologies Ltd 137 Serosep Ltd 138 Technopath Manufacturing
100
HOSPITAL AND/OR HOMECARE PRODUCTS 139 Adhesives Research Ireland Ltd 140 AventaMed 141 Bioquell Global Logistics 142 Class Medical 143 Cook Medical 144 Fleming Medical Ltd 145 GE Healthcare Global Manufacturing Site 1 146 Irema Ireland 147 PMD Solutions 148 Vitalograph (Ireland) Ltd 149 Young Microbrush Ireland Ltd
80
60 098
40
20
OPHTHALMIC 150 Alcon Laboratories Ireland Ltd 151 Bausch & Lomb Ireland 152 Essilor 153 Johnson & Johnson Vision Care 154 Organic Lens Manufacturing ORTHOPAEDIC 155 Archway Orthotics Limited 156 DePuy Synthes Ireland 157 PPL Biomechanics 158 SOTA Prosthetics and Orthotics Ltd 159 Stryker 160 Stryker Ireland 161 Stryker Ireland - Innovation Centre 162 Stryker Ireland - Operations 163 SurgaColl Technologies Ltd 164 Symmetry Medical Ireland 165 TOG Orthotics 063 166 Tornier Orthopedics Ireland Ltd 167 Zimmer Orthopedic
Mapping th medical te sector in Ir
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ATHLONE Galway GALWAY 041
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130 138
SHANNON
Limeri
LIMERICK
112
116
146
SERVICE 168 AiP Thermoform Packaging 169 Crest Solutions 170 DGP Group 171 Eurofins Lancaster Laboratories 172 Eurofoil Teo 173 Fahy Analytical Ltd 174 Firecrest Clinical Ltd 175 Kneat Solutions Ltd 176 M & Q Packaging 177 NuVasive, Inc 178 Olympus Biotech Ireland 179 Pharma-Bio Serv 180 Qualtech Pharma Ltd 181 QUMAS Ltd 182 Seabrook Research Ltd 183 Sightrisk Ltd 184 Tegan Innovations Ltd VASCULAR 185 Abbott Ireland Vascular 186 Boston Scientific Clonmel 187 Boston Scientific Cork Ltd 188 DMC Medical Ltd 189 Stryker Neurovascular
122 106 170
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CORK
172
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www.med-techinnovation.com
Med-Tech Innovation Med in Ireland
he echnology reland
32
093
300+ medtech companies in Ireland
094 097
Donegal
people employed in the medtech sector Sligo
237
243
252
270
278
284
286
295
307
331
333
annual value of Irish medtech exports 226
096
250
254
228
298
202
272
ONGFORD
321
238
249
223 224
251
Dublin
DUBLIN
234 329 279
275
266
Athlone
235
230
DUNDALK
273
231
€8bn
201 285
330
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313
209
ick
292
241
297
323
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263
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225
190
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123
335 113
199
184
185
236
186
Waterford 311
Cork149
334
265
WATERFORD
296
107
108
111
119
151
177
183
184
171
Diagnostic
Vascular
Hospital and/or homecare products
Contract research, development, design and/or manufacturing
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Connected health
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www.med-techinnovation.com
PRODUCED IN ASSOCIATION WITH
East Region
264 Trinity Biotech Plc 265 Waters Technologies Ireland Ltd 266 Welch Allyn Ltd
CONNECTED HEALTH 190 Ace Health Innovations Ltd 191 Baywater Healthcare 192 Beats Medical 193 Captec Ltd 194 Cerner Ireland Ltd 195 Clinical Trial EndPoint (CTEP) Ltd 196 Clintech Health Care Ltd 197 dabl 198 DMF Systems Ltd 199 Emergency Response Ltd 200 Global Diagnostics Ltd 201 HealthComms 202 Heart Rhythm International 203 Helix Health Ltd 204 IMS MAXIMS 205 IncaClinic 206 InsulCheck 207 INTEL – Digital Health Group 208 MANITeX 209 Netcare Wellness 210 Neuromod Devices Ltd 211 Ocuco Ltd 212 Oneview Healthcare 213 OpenApp 214 Presidion 215 ResMed 216 S3 Group Ltd 217 SensorMind Ireland 218 Shimmer 219 Sláinte Healthcare 220 Tele Health Services Ltd 221 Valentia Technologies Ltd
HOSPITAL AND/OR HOMECARE PRODUCTS 267 Advanced Surgical Concepts 268 Allogen Biotech 269 AltaScience 270 AMS Medical Systems (AMS) 271 Arann Healthcare 272 ArcRoyal Ltd 273 B Braun Longford 274 B Braun Medical Ltd 275 BD Penel Ltd 276 BD Penel Ltd 277 Centric Health 278 Covidien 279 Covidien 280 ENBIO Ltd 281 Fannin Healthcare 282 Fresenius Medical Care (Ireland) Ltd 283 Incereb Ltd 284 Innocoll Technologies Ltd 285 Integra Lifesciences Ireland Ltd 286 KCI Inc 287 Mallinckrodt Pharmaceuticals 288 Meditec Medical Ltd 289 Miravex Ltd 290 Smartsplint 291 Trulife Ltd 292 VascoCare Medical Ltd 293 Vasorum
CONTRACT RESEARCH, DEVELOPMENT, DESIGN AND/OR MANUFACTURING 222 Adama Innovations 223 AmRay Medical 224 AQF 225 Automatic Plastics Ltd 226 Bellurgan Precision Engineering Ltd 227 Bioplastech Ltd 228 Blueacre Technology Ltd 229 BlueBridge Technologies 230 Endura Coatings Ltd 231 Europharma Concepts 232 Finesse Medical Ltd 233 I360 Medical 234 Innovative Polymer Compounds Ltd 235 Kelpac Medical Ltd 236 Lake Region Medical Ltd 237 M & V Medical Devices Ltd 238 Mergon International 239 Movement Industrial Design 240 neoSurgical Ltd 241 Nypro Healthcare 242 Oceana Therapeutics Ltd 243 PPD Development Ireland Ltd 244 Pressco Ltd 245 Profector Life Sciences 246 Renishaw Electronics 247 Specialty Coating Systems 248 Tech Group Europe Ltd 249 Technical Engineering Group 250 Tool and Plastic Industries Company Ltd 251 Trend Technologies Mullingar Ltd 252 Utah Medical Products Ltd DIAGNOSTIC 253 Aalto Bio Reagents Ltd 254 Abbott Ireland Diagnostic Division 255 Biosensia 256 Covidien 257 DiaSorin Diagnostics Ireland Ltd 258 EKF Diagnostics 259 Enzolve Technologies Ltd 260 Kjaya Medical Ireland Ltd 261 Quest Diagnostics 262 Siemens Healthcare Diagnostics Manufacturing 263 T Coag
OPHTHALMIC 294 Abbott Medical Optics 295 Athlone Optical 296 Carl Zeiss Vision Ireland Ltd 297 Rupp + Hubrach Optik Gmbh ORTHOPAEDIC 298 Allard UK 299 Mainstay Medical Ltd 300 X-Bolt Orthopaedics SERVICE 301 3M Ireland 302 Abbott Ireland 303 Allergan Pharmaceuticals Ireland 304 Ash Technologies Ltd 305 Autocal (Ireland) Ltd 306 Baxter Shared Services & Competencies Ltd 307 Bioclin Research Laboratories 308 Catalent Pharma Solutions 309 Claymon Biomnis 310 Colorman (Ireland) Ltd 311 Consort Case Company (Ireland) Ltd 312 Covidien 313 DSV Solutions 314 Essentra Packaging Ireland Ltd 315 GE Healthcare Sales And Service Support 316 ICON Research 317 IMEC Technologies 318 Java Clinical Research Ltd 319 KCI Medical Products Ltd 320 Komax Systems LCF SA 321 MDI Medical 322 Mead West Vaco 323 ModusLink Kildare 324 Mylan Dublin Respiratory 325 Omega Teknika Chefaro Ireland 326 OptiCal Sciences 327 Quintiles Ireland Ltd 328 Sealpack Labelling Systems 329 SteriPack 330 Synergy Health Ireland Ltd 331 Teleflex Medical Europe Ltd 332 Venn Life Sciences Ltd 333 Zenith Adhesive Components VASCULAR 334 C R Bard 335 NeuroTronik Ltd
While the coordinators have made every effort to ensure that the information in this map is accurate, we do apologise for any inconsistencies. Stakeholders who wish to amend map, please contact IMDA on 01 6051529 or info@imda.ie. It is anticipated that updates will be supported on an ongoing basis and completely at the discretion of IMDA. Date of Publication October 2014. E&OE.
September/October 2015 ¦ 19
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Med-Tech Innovation Med In Ireland
Get free trials at Clindox Clindox is launching its new CRFweb application at Med In Ireland. As a competitively priced, but fully featured, web-based eCRF platform, CRFweb aims to lower the entry point for clinical trial software and drastically reduce set-up time to hours and days, rather than weeks and months.
C
lindox founder Mats Forsgren says that ‘we’ve had really positive feedback from our customers and believe the application’s scope, flexibility, and set-up speed makes an ideal fit for the dynamic nature of clinical trials in the med-tech industry.’ So why, specifically launch at Med In Ireland 2015? The answer is simple, explains Forsgren. ‘We’re an Irish based company, and after several years in development and a soft launch early this year, the timing is perfect to announce our system to the market. Ireland is at the hub of the med-tech industry, so Med In Ireland is the perfect time and place for us to meet potential customers.’ Show visitors to the Clindox booth will have the opportunity of ‘a free trial where we will invest the time to set up a client’s Case Report Form, which also offers a
healthy incentive towards the first purchase. We want to make it as easy as possible for organizations to try our system. We have great confidence that seeing will be believing.” Clindox is a company formed by Scandinavian, British and Irish entrepreneurs with the specific goal to develop groundbreaking clinical trial software.
Automatic choice
Nelipak Healthcare Packaging, a global provider of custom thermoformed packaging, will be exhibiting at Med In Ireland and available for one-on-one meetings to discuss its comprehensive packaging design, development and manufacturing capabilities. The company specializes in medical trays and blisters, surgical procedure trays, pharmaceutical handling trays, custom-built sealing machines, total packaging solutions and other value-added services. Nelipak Healthcare Packaging has designed and built a range of custom-made sealing machines, ideal for Class 7 cleanroom use. Easy to operate, with low maintenance requirements, these high performance tray and blister lid sealers come with a range of options to suit any manufacturing need.
www.med-techinnovation.com
Automatic Plastics will be laying out its credentials as the med-tech moulder of choice at the Med In Ireland show on October 29th. Andrea Cawley, company Sales Director, notes three primary criteria in getting value for money from your med-tech manufacturing. Mould design and cavitation: choosing between hard and soft steel, analysing the impact the material will have on the mould, the life expectancy required from the tool and the forecasted volumes of annual product, are just some of the key factors in deciding what is the right mould for the project. Guaranteed shots and preventative maintenance: In project building the tool, the number of guaranteed shots can impact the projected future investment that may be required on mould refurb or potentially replacement moulds. A commitment from the injection moulder on planned preventative maintenance programme is therefore essential to avoid potential issues. Trials and validation: with the challenges that FDA approval and external audits bring, it is essential to agree the critical dimensions and aesthetic requirements of your product prior to moving forward to volume production. Validation of the moulds is a time consuming and lengthy process and it is critical that the selected injection moulding partner project plans this element in robust detail. ‘These elements are just some of the key stages in how we at Automatic Plastics achieve consistent and rigorous quality on volume production for our clients in the medtech and pharma space. Our focus is not only on our client, but on the end user, and the needs and demands that they have. That focus is critical in this sector.’ September/October 2015 ¦ 21
Med-Tech Innovation Med In Ireland
Boosting the NHS Irish-based healthcare software company, IMS MAXIMS will field a large team of experts at Med In Ireland.
T
he company – with offices in Dublin and Milton Keynes – is fast gathering a reputation for its pioneering work towards adopting open source technology in the UK’s National Health Service
(NHS). With support from NHS England, open source is now recognised as an alternative approach to creating efficient, integrated patient care records across all care settings. The benefits to NHS trusts include high levels of uptake and clinical user acceptance, speed and flexibility of deployment and implementation, along with the delivery of short and long term cost efficiencies and improvements in patient care. Wye Valley NHS Trust has become the latest UK healthcare provider to sign up to an open source EPR after agreeing a five-year service contract to implement the openMAXIMS EPR software. This will support the creation of accurate, accessible and integrated care records across its acute and community hospitals. The system will eventually integrate across multiple care settings, including social and primary care.
Leesa Ewing, business development director at IMS MAXIMS, said: ‘Med In Ireland provides a good opportunity to demonstrate, as an Irish company, the successes that have been achieved throughout the UK’s health system. It is also a chance for us to showcase our open source software and the significant benefits it can deliver to the healthcare sector and the integrated care agenda.’ The experienced IMS MAXIMS team will be on hand in the medical technology zone to discuss the benefits and answer questions about its innovative, industry-changing open source electronic patient record system (EPR) and patient administration system (PAS) software, called openMAXIMS. IMS MAXIMS solutions are currently used in more than 150 organisations by 20,000 system users to manage over 13 million patient records throughout the UK. Hospitals that use IMS MAXIMS products include Taunton and Somerset NHS Foundation Trust, St Helens and Knowsley Teaching Hospitals NHS Trust, and Blackpool Teaching Hospitals NHS Foundation Trust.
The art of relating Med In Ireland exhibitor RelateCare was formed in 2011 as a partnership between the Irish services company, RigneyDolphin, and one of the most respected healthcare brands in the US, Cleveland Clinic.
S
ince then, RelateCare has grown consistently as an independent organisation, with clients in North America, Europe and the Middle East. In Ireland, they manage the HSE’s successful smoking cessation service, QuitLink.
22 ¦ September/October 2015
This year’s event will see the company visited by a large roster of varied international clients; hospitals, clinicians, companies and educational organisations. The company is both a consultancy and outsourcing organization and provides technical expertise in healthcare contact centre operations, and clinical expertise in the design and implementation of telehealth and clinical calling programs. Service offerings include Guided Scheduling Questionnaires - aimed at improving appointment scheduling operations - to Post Discharge Calling Programs that help reduce unnecessary readmissions to hospital. On October 29th , RelateCare is particularly interested in ‘buyers that are interested in patient access, patient communication, and patient engagement solutions to come visit our stand, so we can share the depth of our knowledge and expertise.’
www.med-techinnovation.com
Med-Tech Innovation Med-Tech Innovation Expo
The Medical and Healthcare Product Development Partners Quris Innovation have in excess of 20 years experience in the development of innovative medical and healthcare products. Contact us to find out how we can help realise your ideas.
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Flexible Polymer solution casting™ can achieve both flexibility and kink resistance along a catheter shaft by utilizing polymer layers, and also encapsulating multiple components like wire reinforcements.
Avalon Catheter Solutions Regulatory affairs and compliance support to medical device & pharmaceutical companies globally. Medical Device Services include: • CE Marking • Device Vigilance • Quality systems auditing • Post-market Surveillance activities • Clinical Evaluation Report
Also providing EU Authorised Representative services for non-EU medical device and IVD manufacturers and act as legal representative for CT applications. Acorn Regulatory Consultancy Services Limited Clonmel, Co. Tipperary Ireland P: + 353 52 61 76706 E: info@acornregulatory.com W: www.acornregulatory.com www.med-techinnovation.com
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NordsonMEDICAL.com September/October 2015 ¦ 23
Med-Tech Innovation Entreprenurs
Young engineers win backing for med-tech projects Two young medical inventors, Sorin Popa and James Roberts have been named among the UK’s most promising young technology entrepreneurs by the Royal Academy of Engineering – for inventing a device that could eliminate the need for surgery and for creating an inflatable incubator in order to prevent the deaths of premature babies in developing countries.
T
he entrepreneurs were chosen from the nationwide Launchpad Competition and will now get access to world-class resources, angel investors and business networks of over 100 mentors through the Royal Academy of Engineering ‘Enterprise Hub’. Sorin Popa’s Stent Tek is a British company pioneering a new way to use a small, covered tube known as a ‘stent graft’ to connect the vessels in almost any part of the arm, through needle-sized punctures, which could enable patients to receive lifelong kidney dialysis without requiring surgery. The company has already won a £166,000 ‘Smart Award’ from Innovate UK and a £1 million grant to develop the technology in partnership with Imperial College London. Furthermore, surgeons could eventually also employ Stent Tek’s innovation as an alternative to openheart surgery for coronary bypass operations. For the dialysis application alone, there is an estimated $1 billion global market in terms of the number of annual medical procedures the technology could address. Stent Tek aims to bring the technology to the market by 2018 where it could eventually save the NHS an estimated £45 million a year. Over 27,000 UK citizens and 2.5 million people worldwide have kidney conditions, which require their blood to be routinely externally filtered by regularly hooking up their circulatory system to a dialysis machine. Currently, this requires patients to undergo invasive surgery to prepare their blood vessels, by forming a connection between an artery and a vein in their arm (known as a fistula or vascular access site). However, fistulas frequently clog up and fail, which can endanger 24 ¦ September/October 2015
patients’ lives and require expensive repair operations. Although they are seen as the gold standard in medical care, fistulas are unreliable, often becoming blocked and requiring repeated costly repair operations. In the US alone, $US 4.6 billion is spent annually to treat failing fistulas. Stent Tek’s ePATH system offers a more intuitive and less invasive system for patients. Now researchers from Imperial College London are developing the first minimally invasive procedures and products. The team has developed prototype technology for inserting the stent graft between a patient’s artery and vein with precision and accuracy. The new device is called an Electronic Percutaneous Anastomosis Technology for Haemodialysis or ePATH. The researchers have received £1 million funding from the NHS National Institute for Health Research to further www.med-techinnovation.com
Med-Tech Innovation Entrepreneurs
develop the system and take it through patient trials. The ePATH system will help some patients with kidney failure to avoid open surgery before beginning dialysis treatment. This is because the ePATH catheter system creates a vascular access site in a minimally invasive manner, creating less trauma for patients, leading to faster recovery times, and being able to use dialysis machines sooner. The ePATH system enables surgeons to insert the catheters into the vein and artery through tiny needlesized punctures in the skin, instead of opening up the arm. The surgeon would guide two catheters through to the artery and vein to the appropriate site in the arm, where an electronic alignment system is activated, manoeuvring the catheters so that they are properly lined up. A small needle would then cross from one catheter to other, effectively creating a channel between the two. A guide wire would then be passed through the needle, and another catheter inserted. This final catheter deploys the stent graft, which remains inside the patient’s arm to form the connection between the vein and artery. Sorin Popa devised the underpinning research for this technology while doing his MRes in Medical Device Design and Entrepreneurship, in the Department of Bioengineering at Imperial College, London. His research was co-supervised by Dr Robert Dickinson and Professor James Moore Jnr, who are both from the Department of Bioengineering. Mr Jeremy Crane, who is a consultant vascular surgeon at Hammersmith Hospital, was Popa’s clinical supervisor. Popa says that ‘there is a real and growing problem with patients around the world who are having repeated operations to repair their failing fistulas. A major challenge is getting new technologies like ePATH to patients to improve their treatments. Imperial offers one of the only Master’s courses in Europe that gives researchers like me a solid grounding in business planning. It has helped to lay the foundations for Stent Tek - a company that that is developing a technology that could reduce the impact of treatments on patients who are preparing for dialysis and reduce costs for healthcare systems worldwide.” The team is planning to move to the next phase and start in-vivo trials in 2016. In early 2018, they then aim to carry out clinical trials with patients. Following this stage, the team expect to get the technology approved for market release in Europe and the US and into the European market by late 2018 In the future the team predict that their technology could have other applications including improving coronary bypass procedures in patients with heart conditions and opening up arteries that are blocked. Preventing premature baby deaths in the developing world – James Roberts, 23 While studying product design and technology at Loughborough University, James Roberts was deeply affected by a Panorama documentary about the Syrian war which revealed that premature babies were dying unnecessarily in refugee camps due to a lack of basic incubators, which are widely available in the West. He was inspired to find a way of developing low-cost incubators that could be swiftly and easily transported www.med-techinnovation.com
James Dyson CBE with young med-tech inventor James Roberts
across warzones and underdeveloped regions, and stored easily. 1 million children die each year due to being born prematurely and it is estimated that 75% of these deaths could be solved with simple treatments such as incubation. This is partly because the high cost of making and powering traditional incubators, and the difficulty in transporting them to remote or war-torn regions, means that many parts of the developing world have no access to the technology. James invented a revolutionary inflatable incubator which can be quickly flat-packed down for easy storage and powered for 24 hours from a car battery. The tiny incubator could be sold for 1/30th of the price of traditional incubators, opening it up to a mass market across the developing world. The technology recently won the prestigious James Dyson Award. Having been invited by UKTI to speak at an event in Japan alongside senior engineers from well-known corporates, and with trips in the pipeline to locations around the world, James’s company MOM Incubator is already aiming to be a global success.
September/October 2015 ¦ 25
Med-Tech Innovation Trade Mission
Orange is the colour The Dutch Government is successfully mobilising both inward and outward-bound trade missions in support of its med-tech industries. Last month saw the service at work at NHS Expo, Manchester UK
Med-Tech in Holland så4HEå.ETHERLANDSåISåHOMEåTOåAå,IFEå3CIENCESå(EALTHå cluster of more than 3,000 life sciences and med-tech companies and research organizations, all within a 120-mile radius så4HEå.ETHERLANDSåRANKSå THåWORLDWIDEåINåLIFEåSCIENCESå and health patents. så4HEå.ETHERLANDSåYEARLYåEXPORTSåABOUTåçå åBILLIONåINå TOTALåOFåWHICHåçå åBILLIONåISåPHARMACEUTICALåANDåTHEå rest medical technology and medical and laboratory instruments. så4HEåMED TECHåSECTORåINVESTSåSOMEå åBILLIONåEUROSåINå R&D in the Netherlands each year and is becoming a globally recognised stronghold of open innovation. It already accounts for 2.5% of GDP.
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rom September 1-4, a delegation of Medical Technology firms from The Netherlands visited the UK to learn about the healthcare sector and share their innovative products and systems. The Dutch company delegation included disciplines such as infection control, surgical equipment, diagnostics, precision engineering, imaging applications, wound care, e-health solutions and management of hospital data and records. The main goal of the trade mission was to enable participating companies to gain insight in the workings of the NHS, to find new British partners and distributors; and establish new partnerships by discussing directly with NHS officials and UK companies what the Netherlands can offer in terms of technology and highquality equipment in health care. During the four day visit, the delegates participated in a full day at Citylabs in Manchester to learn about the greater healthcare ecosystem in Greater Manchester, and a two day attendance at the NHS Expo with a Holland Pavilion. Speaking for the Dutch trade mission, Roxana de Raad said that ‘the UK is an important partner for The Netherlands in the healthcare and technology sectors. This trade mission is a great opportunity for both countries to build long lasting relationships and share new innovations.’ When asked why the international trade mission chose Manchester as its locations, the response was clear; “Greater Manchester is one of the fastest growing economic regions in the world and the progress that is being made around the Corridor in technology and health innovation is amazing. Within 1 hour’s travel there are 14 million potential patients that 26 ¦ September/October 2015
Manchester played host to NHS EXPO and the Dutch trade mission
would benefit from new healthcare innovations. We would be honoured to be a part of it. A ‘Dutch Demo Hour’ on the first day of the NHS Expo presented an opportunity for visitors to view some of the innovations in a real-life environment. Also speaking during the Dutch Demo was Mr. Simon Smit, Director General of the Ministry of Foreign Affairs. The participating Dutch companies responded very positively to the Expo attendance. The high level of decision makers attending the event resulted in valuable direct feedback and discussion. Dutch participants have been offered trials in UK hospitals, have found new networking partners and established a platform to further their progress in offering new treatments and technologies to UK patients. One company commented that ‘the British visitors are very open to seeing new products and are happy to think with you for even better solutions. One visitor even suggested a whole new use for our product that we hadn’t yet thought of, showing how the UK is forwardthinking and committed to offering the best patient care. The Expo for us has been a great success.’
Individual suppliers were able to make significant impact on the UK market
www.med-techinnovation.com
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September/October 2015 ¦ 27
Med-Tech Innovation Healthcare
A need to prove value Demand for healthcare is rising in the UK and globally, while the NHS has seen an unprecedented funding freeze in recent years. Thishi Surendranathan of KPMG UK Life Sciences examines how the NHS and the med-tech industry can work together in smarter ways in order to help the healthcare system achieve better patient outcomes at lower cost.
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n ageing population is often cited as the key driver for rising healthcare demand (and therefore cost) in developed countries. However, the biggest driver is demand of technological advancement, closely followed by rising patient – read consumer – expectation. In fact, data collected by York University as part of the Symphony project in South Somerset found that across a health and social care system, the number of co-morbidities is a bigger driver of costs than age per se. Medical technology companies will need to be alive to the opportunity driven by the increasing complexity of care, without adding to the burden of costs. Of the relentlessly increasing costs plaguing healthcare systems across the world, it is significant to appreciate that staff costs are the most notable portion. Medical technology can help solve this problem by improving productivity – substituting for the work of expensive healthcare professionals - by cutting duplication, reducing unnecessary care and helping prevent both development of new chronic diseases or deterioration of current diseases (e.g. good diabetes care through effective blood sugar control). However, in order for medical technology companies to succeed, medical technology companies will need to think carefully about their value proposition – how can they help to improve outcomes and lower costs for local healthcare systems? In turn, NHS England, regulators and the government will need to work together to create a more conducive environment for medical technologies to better the lives of patients in an affordable and sustainable way. There has historically been a perception amongst 28 ¦ September/October 2015
those in the med-tech industry that NHS and regulators have not been sophisticated enough in considering the case for new technologies. For example, NHS procurement departments have been accused of cutting short-term costs at the expense of realising long-term value. However, there have been some notable signs of improvement in recent years – the NHS Procurement Strategy, published in 2013, outlined ways in which the procurement function could improve its capability and leadership for the betterment of patient care - while still addressing the need to cut costs in the short-term. Earlier this year NHS England launched a library of Mental Health apps on its high-traffic NHS Choices website; these included Big White Wall (an anonymous digital service that supports people with mental health issues) and Buddy (an app that helps the user record thoughts, feelings and behaviours – designed to complement formal therapy). The library could be a useful experiment to demonstrate how a centrally procured product / service can help improve access to innovative ways of delivering care and potentially reduce overall costs. The recent launch of the Precision Medicine Catapult is a welcome development. This UK-wide network aims to build on the success of similar initiatives in fields such as Cell Therapy and High Value Manufacturing, to promote innovation in precision medicine in the UK. This will necessarily involve easier routes to uptake of technologies within the NHS. The government is currently considering what it can do to enhance the impact of devices, drugs and diagnostics on patient care in its Accelerated Access Review – due www.med-techinnovation.com
Med-Tech Innovation Healthcare
KPMG’s UK Life Sciences practice is dedicated to assisting businesses of all sizes from biotechnology start-ups to large multinational pharmaceutical companies. The Life Sciences team also work closely with the KPMG Healthcare team to understand and deliver on the challenges around convergence. With industry experience, insight and technical support, KPMG is among the leaders in delivering a broad range of audit, tax and advisory services to meet the unique needs of healthcare policy-makers, commissioners, providers and regulators. In addition, with its global network of member firms, KPMG aims to ensure that clients are serviced with the same level of quality and consideration, whether they’re operating in fast growing or emerging markets in the Americas, Asia or Europe.
to be completed at the end of this year. The results of this review will be critical for the med-tech industry, as the UK could have a more cohesive strategy to focus and articulate unmet need, provide more accelerated and flexible pathways to approve new technologies, fund new technologies more sustainably, and lastly improve the ability of the UK to affordably adopt and diffuse new technologies. Despite these encouraging signs, med-tech companies will need to meet the NHS (and other healthcare systems) half way, primarily by presenting a compelling value proposition that payers, providers and regulators cannot afford to ignore. There are examples from across the world of products and approaches that show the way forward. Swasthya Slate, for example, provides a remarkable instance of disruptive innovation. This complex device has been developed and used in India to solve the problem of supporting medical care in remote regions, which are poorly served by healthcare providers and where patients must travel too far or pay too much to access basic medical care. The Slate combines a number of features, including comprehensive point-ofcare diagnostic testing, integrated patient records stored in the cloud, and a means of communication between healthcare providers, all enabled by freely available Android tablet technology. The result is a product whose cost of manufacture is a fraction of that of the infrastructure and technology it would replace in more developed healthcare systems. Most importantly, this device saves lives. It provides 33 different point-of-care tests at the necessary level of accuracy to make critical clinical decisions, and can help detect the development of chronic conditions like diabetes that could be devastating if left unmanaged and untreated. To understand the implications of a piece of technology like Swasthya Slate, one should look no further than Vscan, the portable ultrasound scanner developed by GE Healthcare for use in developing countries with limited healthcare infrastructure. Since www.med-techinnovation.com
its launch, the Vscan has found its way into Emergency Departments across the developed world. A similar successful diffusion of Shwasthya Slate could have a transformative impact on healthcare delivery globally. Increasingly, medical technology companies will need to think carefully about their role in the overall healthcare system and how best they can improve value outside of their current core services. In the US, the likes of Medtronic have gone beyond the traditional core competencies of medical device manufacturers. For example, Medtronic has provided services to manager cardiac catheter labs at Imperial College Healthcare NHS Trusts. As part of an end-to-end solution, a “turn-key” set-up, day-to-day operational management, consultancy and analytics are provided, in order to improve performance on quality and cost metrics. This move to a service model in turn has implications for the way the industry interacts and contracts with its customers. The med-tech interface is also likely to see considerable commercial innovation. For example, we will probably see more frequent examples of innovative payment mechanisms, including risk-sharing agreements and performance-based contracts. Suppliers will align interests more fundamentally with their customers and the end-users through payment on the basis of health outcomes – or more colloquially ‘no cure, no pay’. To ensure the best outcomes, med-tech companies will focus increasingly on the way their products are used as much as their design and manufacture. Given the funding constraints in healthcare in the UK and across the world, med-tech companies are necessarily having to work harder and smarter to ensure their products gain traction. Increasingly, the industry will be expected to solve the productivity issues endemic in healthcare, and to move the focus beyond the direct application of their products to the overall value provided to the healthcare system. September/October 2015 ¦ 29
Med-Tech Innovation Cardiology
Philips heartens ESC Congress ESC Congress is the largest and most influential cardiology event in the world. This year’s London based event saw Dutch medicare giant Philips showcase its innovations and launch a number of others.
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hroughout the event, Philips and its physician partners participated in several online and hands-on tutorials on topics including anatomical intelligence and peri-interventional imaging. The event saw Philips announce the European debut of HeartModel, a new Anatomically Intelligent Ultrasound (AIUS) tool that brings advanced quantification, automated 3D views and robust reproducibility to echocardiology. Using HeartModel, clinicians can quickly, easily and confidently assess disease states, determine treatment, and guide related therapies. In a recent comparison at one hospital, Philips states that clinicians were able to acquire and analyze the data necessary to calculate the dimensions and volumes of the left atrium and ventricle (LA and LV) between 3 and 6 times faster using 3D measurements and HeartModel than with conventional 2D measurements and conventional volume and dimensional analysis. This knowledge-based identification and patient-specific adaptation provides proven quantification of the left ventricle and atrium, and display of routine apical views. ‘Conventional echocardiograms can be very time consuming,’ said Vitor Rocha, CEO, Ultrasound, Philips. ‘Health systems are constantly looking for solutions to provide the most efficient and effective way to help clinicians make confident diagnosis. By combining AIUS with the power of HeartModel, we’re able to deliver technology that helps simplify a complicated exam and makes it more reproducible.’ HeartModel is part of a suite of new tools and technologies available on Philips’ EPIQ 7 ultrasound system and the company continues to leverage its expertise in this area to pioneer organ models. The EPIQ 7 system is designed to enhance automation and reproducibility to help address some of the most critical strains on overburdened hospitals and healthcare systems, which are challenged to provide higher quality care at a lower cost. HeartModel on the EPIQ 7 ultrasound system will be available in most markets by the end of the year. Philips also used ESC for the European launch of IntelliSpace Cardiovascular - a web-enabled image and information management system that provides tools to access, analyze and share cardiovascular images and 30 ¦ September/October 2015
information anytime, from virtually anywhere. The new way in which information is displayed allows all care team members to view the patient’s history spanning diagnosis, treatment and therapy, fostering collaboration and potentially eliminating unnecessary and repetitive tests. ‘IntelliSpace Cardiovascular enables clinicians to take a holistic view of the patient’s cardiovascular journey with one workspace and the ability to dive deeper into more clinical depths’, said Yair Briman, Senior Vice President and General Manager of Healthcare IT for Philips. ‘This includes accessing other third party applications, providing a comprehensive view of the patient, which in turn enables care givers to deliver better patient care.’ In terms of overall design the Philips booth displayed a holistic approach to cardiovascular care, featuring digital tools and capabilities for image guided therapy and ultrasound, intravascular imaging and sensing, treatment, patient monitoring, healthcare IT and advanced software applications. In our next issue of Med-Tech Innovation magazine, we will visit St George’s Hospital in order to report on the installation and performance of Philips patient monitors across the entire hospital site. The tour will include interviews that discuss financing, IT connectivity, planning/install processes as well as the features and benefits of the project from a clinical point of view. www.med-techinnovation.com
Med-Tech Innovation ADV ER T ORIAL
The face of medical devices Virtually every medical device uses some kind of keypad to operate it, but are you aware of all the options? Paul Bennett, Managing Director of Fascia Graphics highlights the important areas to consider…
G
raphic overlays and membrane keypads which
submerged in water. At Fascia, we can also use Autotex® AM
sit on the face of hundreds of different pieces of
with Microban®, by MacDermid Autotype, a unique substrate
medical equipment like heart rate monitors, portable
that has been proven to inhibit the growth of a wide range of
insulin pumps and negative pressure wound devices, come into contact with an endless number of people every day in hospitals across the country. They therefore need to be manufactured robustly to stand up to 24/7 use. Before going into production, it’s a good idea to get some advice from an
bacteria, fungi and moulds for the lifetime of the product. Backlighting or LEDs – Membrane keypads can include special features, such as a ‘secret-til-lit’ function, fibre optics, electro-luminescent back illumination, or surface mounted LEDs – which can be used as warning or indicator lights.
experienced manufacturer on the different features you may want to consider including:
Fascia Graphics has worked for over 20 years in the medical
Appearance - Tailor-made in design,
device manufacturing sector, and
shape and colour, a wide selection of surface
has quickly built up a reputation as
finishes can be combined with a variety of
the market leader. But don’t take
embossing techniques. A hardcoat polyester film gives a brushed stainless steel effect, and chrome ink technology gives a bright metallic finish. Sealability - IP (Ingress Protection) ratings define the level
my word for it. One purchasing manager from a medical supplies manufacturer commented: “We have developed our partnership with Fascia Graphics over a period in excess of eight years, and
of protection a membrane keypad has from the intrusion of
by using the basics of fair pricing quality and delivery, Fascia has
dirt and moisture. Manufacturing to a high IP rating ensures
proven that they have the necessary capabilities to enable them
the keypad is sealed and cannot be damaged even when fully
to stand out from the competition.”
Over 20 years of manufacturing excellence in the medical device industry
www.med-techinnovation.com
September/October 2015 ¦ 31
Med-Tech Innovation Healthcare
XL-PT targets growth in Endoscopy Component suppliers – in all kinds of materials and niches – are the bedrock of the med-tech technology supply chain and SME companies (Small to Medium sized Enterprises) have a vital role to play.
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ed-Tech Innovation magazine caught up with one such, MTI EXPO exhibitor XL Precision Technologies (XL-PT), currently in the middle of a programme of intensive capital investment. The North Eastern medical device component manufacturer has been targeting increased volume in the supply of medical device components with a strategy of investment and a focus on key markets. Based in Stockton-On-Tees in the north east of the UK, XL-PT is a contract manufacturer of precision components for global medical device technology companies in Europe and North America. XL-PT was founded in 1998 with a strong initial focus on Electrical Discharge Machining, building strong relationships with medical device manufacturers in the Endoscopy and Laparoscopy markets. Initially building LINKSĂĽINĂĽTHEĂĽ5+ ĂĽTHEĂĽCOMPANYĂĽQUICKLYĂĽLEARNEDĂĽTHEĂĽSPECIlCĂĽ REQUIREMENTSĂĽOFĂĽTHESEĂĽMARKETSĂĽINĂĽTERMSĂĽOFĂĽPRECISION ĂĽ QUALITYĂĽANDĂĽRESPONSIVENESS ĂĽĂĽ0UTTINGĂĽTOGETHERĂĽAĂĽSTRONGĂĽ team of engineers with sustained growth and proďŹ tability over the ďŹ rst 12 years, the company gained ISO 13485 certiďŹ cation and a good reputation in the market. 2ECOGNISINGĂĽTHEĂĽADDITIONALĂĽREQUIREMENTSĂĽOFĂĽCUSTOMERSĂĽ for micro-joining, especially in the assembly of medical devices made from tubes for the Cardio and Endovascular markets, XL-PT made early investments in CNC laser welding capacity. Soon after, this was augmented by the investment in a laser marking system to provide ďŹ ne and permanent marking of text on arthroscopic electrodes for sports medicine, a high volume application involving EDM. With the addition of 3 dedicated laser cutting systems, capable of cutting ďŹ ne tubes or at sheet components, XL-PT has been able to offer improvements in throughput and capability, together with strong growth in turnover. Two of the most recent laser cutting systems include auto-loaders for the ďŹ ne tubes which can be up to 3 metres in length, enabling the laser cutting systems to run automatically for extended periods. All the laser systems 32 ÂŚ September/October 2015
Darren Vine at EXPO 2015
have been installed in a custom built, environmentally controlled area in the factory. In addition to laser and EDM, XL-PT uses high speed micro machining to provide a full range of ďŹ ne component machining, marking and joining technologies. Over the past three years a plan to concentrate on a few key markets - including sports medicine, drug delivery, cardio and endo-vascular - has expanded the initial focus on endoscopy and laparoscopy. As a result, XL-PT has successfully achieved preferred supplier status in over 20 medium-sized and large global medical device manufacturers. Darren Vine, business development director, says that ‘our successful engagement with new customers in recent years is as a result of being able to directly support the customer at the early development stage of their project. This includes sĂĽ OURĂĽDIVERSEĂĽRANGEĂĽOFĂĽMACHININGĂĽCAPABILITIES sĂĽ OURĂĽABILITYĂĽFORĂĽQUICKĂĽTURNĂĽPROTOTYPINGĂĽ www.med-techinnovation.com
Med-Tech Innovation Healthcare
EDM systems on shop oor at XL-PT
Laser welding systems in our Laser Technology Centre
Implant delivery shaft assembly manufactured at XL-PT featuring offaxis laser cutting and laser welding
Laser processed hypo tubes and sports medicine components
sĂĽ SMALLĂĽCLINICALĂĽSTAGEĂĽDEVELOPMENTĂĽRUNS sĂĽ OURĂĽDESIGNĂĽFORĂĽMANUFACTUREĂĽINPUTSĂĽANDĂĽMANYĂĽOTHERĂĽ factors. /URĂĽCUSTOMERSĂĽCANĂĽQUICKLYĂĽSEEĂĽTHEĂĽRANGEĂĽOFĂĽ competences on offer and the beneďŹ ts of working with XL Precision Technologies. The one stop shop approach has its rationale: ‘Several suppliers,’ says Darren, ‘can offer laser cutting or laser welding; very few can offer the complete range of laser processes together with EDM, multi-axis machining, chemical etching and precision assembly.’ Darren continues ‘it is this combination of process skills that adds the value – and also allows the competitive manufacture of both single components and subassemblies in the medical device industry.’ XL-PT is now growing fast, and is investing in new CAPITALĂĽEQUIPMENTĂĽTOĂĽINCREASEĂĽTHEĂĽVOLUMEĂĽOFĂĽCOMPONENTSĂĽ that can be produced for customers in the UK, Europe and USA. Darren reports recent and rising success in exports markets, ‘particularly to the US and Irish medtech markets.’ XL-PT has particular expertise in making exible metal tubes for steerable surgical devices and has recently more than doubled the in-house capability of ďŹ ne tube cutting with the latest in precise and fast ďŹ bre laser technology.
www.med-techinnovation.com
Multiple laser processes at XL-PT can allow intricate assemblies to be made. An example of this capability is a recent project that combined off-axis tube cutting with laser welding. This produced an implant delivery system assembly, almost 2 metres long and with variable mEXIBILITY ĂĽĂĽ4HISĂĽCLEAN ROOMĂĽASSEMBLYĂĽALSOĂĽREQUIRESĂĽAĂĽHEATĂĽ shrink PET outer sleeve and a PTFE internal liner. Capable of cutting ďŹ ne features, with a cut-width less than 15 microns, the latest laser cutting system allows off-axis cutting. XL-PT maintains that most laser tube cutting systems on the market can only make radial cuts. Throughput at XL-PT has increased as a result of auto-loading and unloading from the laser tube cutter, which allows up to 150 metres of tube to be processed without operator intervention. XL-PT designs and supplies components to cardio vascular surgical device manufacturers, as well as offering components for ophthalmology, sports medicine, endoscopy and orthopaedic industries. 8, 04ĂĽCANĂĽSUPPLYĂĽANYĂĽQUANTITYĂĽFROMĂĽ ĂĽTOĂĽ ĂĽ PARTSĂĽPERĂĽANNUMĂĽANDĂĽISĂĽOPENĂĽTOĂĽNEWĂĽENQUIRIESĂĽFROMĂĽ medical device manufacturers, regardless of geographical location. More than 40% of company sales are exported from the UK, and the total number of components or assemblies shipped annually exceeded 2.4 million items last year. The majority of parts are manufactured from ďŹ ne stainless steel tube – last year XL-PT purchased more than 1.25 million feet of tubing - enough material to reach from Stockton-On-Tees to London! Over the next 3 years, XL-PT predicts further strong growth from existing and new customers. Working with customers to develop the next generation of medical devices is a key part of the growth and partnership strategy. In the ďŹ rst half of 2015, XL-PT secured more than 80 development orders from 20 medical technology companies. XL-PT is exible enough to work with any company from new start-ups, SMEs to many global medical device-manufacturing companies. September/October 2015 ÂŚ 33
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Med-Tech Innovation RSM Summit
RSM hosts medical innovation showcase Twenty of the world’s leading innovators and entrepreneurs in the healthcare field gathered at the Royal Society of Medicine (RSM) on Saturday 12 September for the 11th RSM Medical Innovations Summit.
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peaking to a capacity audience of doctors, medical students, scientists and academics, the speakers on the platform ranged from 17-year old Sarah Sobka, this year’s UK Young Scientist of the Year, to some of the most distinguished medical scientists at the very top of their careers. Offering a platform for innovators to present a range of medical devices, the line-up of speakers at the event included Paul Landau, creator of wearable tech firm Fitbug, and Dr Marie Johnson, who led the development of CADence, a non-invasive, hand-held, fast, extremely affordable device for the assessment of coronary artery disease. Other innovations presented included a rapid Ebola diagnostic kit and the world’s first medical device to detect shock and high blood pressure in pregnant women with the potential to cut maternal deaths in developing countries by up to 25%. Paul Summerfield, who leads the Medical Innovations The RSM London Summits are held twice a year and are well attended.
www.med-techinnovation.com
UK Young Scientist of the Year 2014: 17-year old Sarah Sobka came to the Royal Society of Medicine Medical Innovations Summit to describe her award-winning project to investigate whether a drug commonly used to treat Irritable Bowel Syndrome could be used to treat cystic fibrosis.
programme at the Royal Society of Medicine, said that ‘ss ane of the country’s major providers of postgraduate medical education the RSM’s aim is to provide a platform for discussion and debate on the latest ideas and learning in the field of healthcare. Our well-established medical innovations programme brings together dynamic innovators to share their knowledge, expertise and personal story.” The next issue of MTI magazine will report in more detail on the September presentations.
About the Royal Society of Medicine The Royal Society of Medicine is one of the country’s major providers of accredited postgraduate medical education. Each year, the RSM organises over 400 academic and public events, spanning 61 areas of special interest providing a multi-disciplinary forum for discussion and debate. Videos of many key lectures are also available online, increasing access to the Society’s education programme. The Society has an established medical innovations programme that provides a platform for dynamic innovators to share their knowledge, expertise and personal story. The RSM is home to one of the finest medical libraries in the world, with an extensive collection of books, journals, electronic journals and online medical databases. As well as providing medical education, the Society aims to promote an exchange of information and ideas on the science, practice and organisation of medicine, both within the health professions and with responsible and informed public opinion. The Society is not a policy-making body and does not issue guidelines or standards of care.
September/October 2015 ¦ 35
Med-Tech Innovation Lateral Flow Technology
BBI Group develops rapid Ebola test The BBI Group (BBI) has invented a rapid test for Ebola, developed in collaboration with the Defence Science and Technology Laboratory (Dstl) and licensed through technology transfer company Ploughshare Innovations.
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he assay, which is in the process of being verified to allow EUA submission, will be used to test patients suspected of Ebola infection to screen and potentially help with how they are subsequently managed. The test, utilising lateral flow technology, can provide a result in approximately 20 minutes. More than one year after the initial outbreak, the number of Ebola cases sits at over 27,000 cases reported and 11,000 deaths in West Africa to date. Accurate diagnosis currently relies on skilled laboratory staff and equipment, largely unavailable in the field, and this can result in delays in diagnosis and difficulty containing spread of the virus. Using lateral flow technology, BBI’s assay will make testing simpler and quicker than assays such as RT-PCR that requires technical infrastructure. With minimal training, local health teams can complete the test at bedside and have a result in 20 minutes. In field data suggests the test could be used as a negative agreement ‘rule-out’ test and screening method. In the future, such a test could possibly be deployed at borders to monitor and control spread of the virus. Through collaboration with partners, a lateral flow test has already been evaluated in the field. In trials in Sierra Leone, of 138 participants enrolled in testing, a 100% detection rate was achieved. At a low positive the test achieved 100% sensitivity and 92% specificity, and at a high positive, 100% sensitivity and 97% specificity, making the BBI assay potentially more sensitive and specific than other lateral flow or dipstick type assays currently available to date. Using BBI’s integrated AtomoRapid™ platform, the number of components in the kit is reduced, simplifying the process for end users whilst reducing the risk of user error and cross contamination. Aiming for an imminent launch following regulatory approval, the test will be available for immediate deployment in affected areas. BBI will then roll out to all global territories following their respective regulatory 36 ¦ September/October 2015
Leigh Thomas, Chief Commercial Officer, BBI Solutions
BBI’s Integrated AtomoRapid Platform
R&D at BBI QC testing a lateral flow assay
registration and acceptance. In addition, a second version of the test will be evaluated in combination with the Novarum DX Smartphone reader. This will allow users to read and share test data using smartphone technology. This development could potentially allow instant connectivity of patients and field workers with medical experts, while also utilising built in GPS capability to track and monitor disease ‘hot spots’. Leigh Thomas, BBI Chief Commercial Officer commented, ‘BBI has developed high performance lateral flow tests for some of the world’s leading diagnostic companies for over 25 years. Our expertise and flexibility has allowed us to quickly deploy a team and develop a rapid test in 9 months which, based on field testing, promises to have an immediate and positive impact on the Ebola crisis. We are pleased that our test will meet an immediate need in the field and ultimately improve the lives of others.’ Cardiff-headquartered BBI is a leading manufacturer of raw materials and finished test platforms for the in-vitro diagnostics market. With over 50 years’ experience, BBI has grown from a small specialist company to a global business with manufacturing sites spanning three countries. BBI itself was founded by John Chandler of Cardiff University in 1986. He developed and manufactured the company’s gold nanoparticles and supplied these into the electron microscopy industry. Back then, the company was originally known as Biocell Research Laboratories The company’s range of raw materials now includes human antigens, antibodies, serum and plasma products and clinical chemistry enzymes. They manufacture world renowned labels for lateral flow, ELISA assay and biosensors, including our gold nanoparticles and glucose oxidase. BBI also offers leading edge development and manufacturing services across a number of lateral flow and related platforms. www.med-techinnovation.com
DELIVERING WORLD CLASS MEDTECH SOLUTIONS TO GLOBAL CUSTOMERS We work with innovative medical technology companies and the manufacturing and engineering community in Ireland to deliver world class MedTech solutions to global customers.
For more information on how Enterprise Ireland can help you visit:
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Med-Tech Innovation
NEW PRODUCTS
Owen Mumford boosts product testing GB Innomech (Innomech) has designed and developed a new fully automated test system to help Owen Mumford, a global leader in medical device design and manufacturing, to carry out more efficient batch testing as a final verification of quality for one of its leading auto-injector products. The new system will help significantly speed up product release for shipment and is more than 5 times faster than a previously semi-automated process that needed five different pieces of test equipment, each with its own specially-trained operator. Innomech has integrated all five tests into one easy-to-use system with a total cycle time of less than one minute. The automated system requires just one operator and eliminates the need for any manual handling of auto-injectors between different tests. ‘The Innomech system has also been designed to increase operator health and safety by eliminating previously repetitive manual tasks and the risks in handling fired pens,” said Steve Miles, manager of test methods & validation at Owen Mumford. The operator starts the test cycle by inserting a complete auto-injector pre-loaded with its cartridge of active drug into the Innomech machine. The system then measures the forces required to remove the auto-injector’s safety cap and to fire the trigger, the dose time, volume of dose delivered and the distance the needle protrudes from the body of the device. The cycle ends with the fired
device being automatically ejected from the machine into a sharps bin to protect the operator from the risk of any accidental scratches or puncture wounds. GB Innomech (Innomech) specialises in automating highly complex and labour-intensive manufacturing processes to maximise outputs, improve product quality and boost business performance. In business for over 60 years, Owen Mumford remains privately owned and offers proven design, development and delivery services from a broad base of proven self-injection and blood sampling platform devices, and intellectual property. Owen Mumford’s medical devices are exported to more than 60 countries worldwide, representing over 85% of production.
UPM innovates product handling Langley based UPM Conveyors is experiencing increasing demand for a variety of product handling needs in UK medical manufacturing industries. Director Roy Fowler says that ‘the med-tech sector in the UK & Ireland is experiencing a period of rapid change, brought about by a combination of increased regulatory pressure, ever-changing demands on healthcare budgets, and constant emphasis on quality, requiring a truly collaborate approach. To help our customers meet all of these challenges UPM Conveyors invested close to £50,000 in Autodesk’s Inventor 3D software.’ The new software is used for creating digital prototypes, and UPM is finding that visualizing and simulation product handling solutions is of great benefit to customers. The conveyor image can be rotated through 360 degrees, thus eliminating any risk of the system not interfacing to existing equipment. It can also be properly sized within the allocated client production area. The new software also includes assembly stress analysis, allowing the input of driving loads, friction characteristics 38 ¦ September/October 2015
and dynamic components. It will then run dynamic simulation tests in order to see how a product would work under real life conditions. UPM enjoys preferred supplier status with many clients in UK Med-Tech sector. Its new modular system is key to maintaining such status. A conventional belt conveyor stretches a belt over two rollers, and after only a few weeks’ operation the belt will stretch, thus requiring further tensioning and tracking. UPM Conveyors has developed an alternative system based on High Molecular Weight Polyethylene. This material is FDA-approved for medical and food contact applications and is supplied in 3M x 2M sheets. UPM cuts the material to order on its CAD controlled in-house router. In this way it also forms the side members of the conveyor. The true innovation lies in running the belt into a channel, thus eliminating the need to track and tension the belt. Together with all stainless steel supports, this plastics-based conveyor can be employed in high care clean room conditions. www.med-techinnovation.com
Med-Tech Innovation Advertorial
Design Validation / Verification of Medical Devices CE marking and FDA registration of medical devices and IVDs requires design validation and design verification. Design verification: have the component parts been design correctly to deliver their intended function correctly and safely? Design validation: does the finished device deliver its intended function correctly and safely? An example of how best practice may subtly differ between verification and validation is biocompatibility testing. The biocompatibility of the entire device as it is presented to an end user must be validated; this is usually effected by testing of the sterile market ready device according to ISO 109931. But, it is very desirable that any exposed materials are individually biocompatible, this can normally be verified using the material manufacturer’s biological safety data (or materials characterisation to ISO 10993-182) as the product design progresses. The American and European requirements are usually very similar. Assuming that your design and production is all correct under ISO 134853 certification, then addressing the Essential Requirements4 will validate the design for CE marking. There may be specific FDA Guidance for your device which indicates areas in need of increased vigilance. In the majority of cases this will coincide with any ISO or ASTM standards which refer specifically to the device concerned. This is not always the case. Taking bone cement as an example, ISO 5833:20025 is largely concerned with the liquid properties of the cement prior to setting and its static properties once set. Whereas the relevant FDA draft Guidance6 references a number of ASTM standards for assessing for static and fatigue properties of the set material. There is also a greater emphasis on chemical analysis and its change with time, in the FDA document. Risk analysis is always required throughout to highlight any other areas that might require safety validation. For more complicated devices ISO 623667 gives advice on ease of use. Laboratories such as Medical Engineering Technologies Ltd8 www.med-techinnovation.com
(www.met.uk.com) can assist medical device developers to conduct their risk analyses, and to understand the product standards and Essential Requirements for their product. The laboratory can then draw up a validation and testing plan to include performance and safety testing, biocompatibility, chemical analyses and shelf life stability.
Ref 1 Ref 2 Ref 3 Ref 4 Ref 5 Ref 6
Ref 7 Ref 8
ISO 10993-1:2009 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process ISO 10993-18:2005 Biological evaluation of medical devices – Part 18: Chemical characterization of materials ISO 13485:2003 Medical devices – Quality management systems – Requirements for regulatory purposes Directive 93/42/EEC on Medical Devices (MDD), Annex 1. ISO 5833:2002 Implants for surgery – Acrylic resin cements Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement; Guidance for Industry and FDA, FDA July17, 2002. EN 62366:2008 Medical devices - Application of usability engineering to medical devices Medical Engineering Technologies Ltd, www.met.uk.com
September/October 2015 ¦ 39
Med-Tech Innovation Recruitment
MANPOWER for Med-Tech Samantha Blythe-Moore, Director of Medical Engineers, begins her column on industry recruitment matters – with some words of encouragement for SME companies in the Med-Tech sector.
T
he plain truth of our recruitment market place is that this is a candidate driven industry. In other words, there are far more opportunities than people to fill them. The picture varies across the UK; some statistics quote 7:1 in Cambridgeshire and 4:1 in the north of the UK across engineering disciplines. This often means reaching out to other EU countries and further afield to find talent. This talent shortage does not look as though it’s likely to change much. Currently we are seeing a distinct shortage of skills in the product development field; mechanical engineers, product development engineers, bioengineers, software engineers, specifically at the 5-7 years post graduate level. Given this backdrop I’m often asked by our Small to Medium sized (SME) company clients how they can compete with large corporations when securing top talent for their businesses. As with any business, knowing your strengths is important. SME’s are likely to be far more agile in their recruiting, with less decision-makers involved and generally more hiring manager engagement. However, if it takes three weeks to respond to an applicant (or no response at all), another month to arrange a first interview, and another for a second stage interview, what does this say about how dynamic and innovative you are as an employer/business? It is therefore crucial that you set yourself apart from your competition - and for the right reasons! Here then is a brief checklist – principally for the SME company who wants to makes the most of his/her flexibility and agility in hiring the right people. Do Make time for the process. Messing candidates about is seriously bad press for your company. Candidates remember the bad recruitment experiences (and publish them on Glassdoor) far more than the good ones, which they didn’t get an offer from. A full market appraisal. Either do it yourself or use specialist recruiters who know your market, but know what this role is currently earning, basic salary and 40 ¦ September/October 2015
benefits before you start the process. Write a compelling job advert. Candidates want to know ‘what’s in it for me’ and I’m not talking about salary and benefits (although this cannot be ignored)…. trail blazing projects, working with an inspiring team of world class experts, development opportunities etc. Ensure all those involved in the recruitment process are aligned on the skills and behaviours needed for this hire. Map out the recruitment process and set a timeline. 1st interviews on this date, 2nd on this date and offer by the next. Candidates left wondering what’s going on will keep their options open and will wander themselves. Do Not Assume that by keeping the applications window open, something better will come along. This is highly unlikely, lengthens the process and ensures that candidates will lose faith in the recruitment process. Assume that if a candidate responds to a job advert, they want the job. An advert response is simply a candidate saying ‘this sounds interesting, I’d like to find out more’. This is a two way process, you still need to sell the opportunity, culture and business, to secure the best candidate. Assume, once a candidate has accepted your offer and signed a contract, it’s ‘in the bag’. Handing in their notice is when the candidates can be tempted by counter offers and pleas from work colleagues and bosses. Stay in touch with your candidate, take them for coffee and invite them to work socials during their notice period. Make them feel part of the team, even before they are. Forget how it feels to be on the other side of the interview process. Be punctual, give good feedback and always leave the candidate feeling positive about your business.
And don’t forget to check out all the med-tech job opportunities on our med-techinnovation.com website – For med-tech engineering jobs – click here. http://www.med-techinnovation.com/Recruitment/home
www.med-techinnovation.com
Med-Tech Innovation Advertorial
Ask eg
When to outsource engineering design Introduction Today’s markets change rapidly and a company’s success is linked to its ability to generate innovative products that are market-applicable quickly and cost effectively. The advantages that can be achieved by being first-to-market and developing products in advance of competition means that there is now increased pressure on the development process to deliver results in a shorter time frame with better return on investment. Whilst completing product design and engineering developments in-house has advantages, considering outsourcing part or all of your product design requirements can help keep your competitive edge. Why would you outsource engineering design? Outsourced engineering provides businesses with options, both for providing skills and for resource. Companies may need to consider tapping into a skill or an area of expertise that is not already held in-house or required for the company’s normal workflow. Recruiting for a position when it is not critical to the business to develop that competence internally is not generally cost effective nor an efficient use of labour long-term. Even the most innovative companies turn to engineering design consultants to meet particular needs. Outsourcing specific skills can also have a positive impact on internal teams as it enables them to be free to work across multiple projects whilst accessing this expertise. Whereas recruiting skills takes time to build an in-house team, outsourcing a design project will enable the company to start the process quickly and efficiently. This will lead to a company structure that is focused on the core innovation and the development of the business to serve the market. Some companies may have the idea but not the internal capacity to turn it into a reality. An engineering design company can offer the capability to take this idea and turn it into a marketable product. This enables the company to outsource the design at an agreed cost and to focus internal efforts on the manufacturing, distribution and sale of the end product. Using an external supplier who already has established product development processes should enable start-ups and smaller organisations to become competitive by getting their ideas to market quickly, efficiently and cost effectively. Who would you outsource engineering design to? The real benefits from outsourcing will be determined by the quality of the company you select to work with. Establishing a close working relationship will ultimately result in your chosen company becoming a trusted partner, one you can rely on to understand your needs, communicate with openly and efficiently and support you for all of your design requirements Don’t let size be a limitation either way. Small firms are often extremely responsive whilst still offering a full design service with a personal touch;
large firms can sometimes offer a larger range of expertise and experienced teams to support this. Experience and education, staff turnover, innovative design successes and track record are the important factors you should be considering when looking at potential engineering design companies. Consistent and trusted relationships develop and can stay with the customer for the longevity of the project (and future projects). Be mindful that the company should be large enough that you are not dependent on a single employee and any staffing changes in the organisation would therefore have minimal or no disruption to the project. An established engineering design consultancy with a good track record should be able to provide you with relevant references from people who have chosen to work with them.
How would you ensure outsourcing is successful? Preparation is important when working with your chosen design engineering firm. Ensuring that clear targets and deliverables are established and agreed at the very beginning of the process will prevent misinterpretations resulting in design rework, which will have an impact on your budget. Clear and formally agreed specifications and processes will enable projects to run smoothly and result in the desired outcome so it is important to choose a company with the correct quality standards for your development. Make sure that the IP status is very clear and only outsource engineering to a company that doesn’t claim IP (unless IP sharing and licensing is part of the overall business strategy). When would you outsource engineering design? The best time to outsource engineering design is when you will maximise your return on investment. If you have made a decision to use an external company, involving them in the early stages of the process will enable them to identify and advise on (or improve) product elements and associated manufacturing processes for cost reduction. Understanding the need to outsource, choosing the optimum moment at which to bring in an external consultancy, and being prepared to work with them in a considered partnership will help you to have a successful experience with your engineering design consultancy.
NEW ADDRESS
eg technology Ltd, Fairfield House, Albert Road, Stow-cum-Quy, Cambridge, CB25 9AR, UK tel: +44 (0)1223 813184 www.egtechnology.co.uk Email your question to: expert@egtechnology.co.uk
www.med-techinnovation.com
September/October 2015 ¦ 41
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