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Issue 26 November/December 2015
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Connected operations Get ready for EXPO 2016!
Expo 2016 20-21 April Ricoh Arena, Coventry UK
www.mtiexpo-uk.com The only major event serving the UK £18bn medical technology industry
Irish cheers – Med In Ireland review Designing for med-tech – NEW Just met a machine called MARIA Google glass for surgeons
OKED O B U O Y HAVE ITION B I H X E R YOU T? STAND YE
The only event in the UK serving its £18 billion medical device industry. 100% dedicated to research, development, design and manufacture of medical devices. Ricoh Arena, Coventry on 20 – 21 April 2016
Visit our website for more information www.mtiexpo-uk.com email colin.martin@medtechcomms.com or call us on +44 (0)1293 710042
Med-Tech Innovation Contents
Contents ¦ November/December 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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EXPO 2016! April 20-21, Ricoh Arena, Coventry. Colin Martin urges all to set the date.
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MED-TECH IN IRELAND Our follow up look at this vibrant scene. Includes our Med In Ireland show review.
MedTech Communications Ltd Meadow Court Faygate Lane Faygate West Sussex RH12 4SJ UK
19 DESIGN FOR MED-TECH Richard Hall of pd-m and Design Council mentor opens up a new front on product design for medical and healthcare
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. ©
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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21 THERMOFORMING MED-TECH A tour around the innovations at Wokingham-based Compamed exhibitor CWP 22 LET THERE BE LIGHT Important new technology from Lightpoint in the battle against cancer 24 STEPPING OFF Wearable technology and pressure sensors contribute to this product innovation for diabetic care 25 FRAMEWORKS FOR THE ELDERLY Best practice methods for elderly healthcare and med-tech
32 32-22 VISIONARY - BY GEORGE We look at the impressive systems supplied by Philips Healthcare to St George’s University Hospital, Tooting 35 MEDICAL MOULDING MACHINES Wittmann Battenfeld launches injection moulding machines - bespoke for med-tech needs. 36 HAND MADE DESIGN RP Technologies create ingenious prosthetics 38 WIDE EYED OPPORTUNITY Opthalmic specialise Sterimedix invests in new equipment 39 GOOGLE FOR SURGEONS Spinal procedures create opportunity for wearable interface
26 MARIA – A PROBLEM SOLVED Our High Streets could soon be home to this radical new screening treatment for breast cancer
40 ADVICE FOR THE CANDIDATE Our Med-Tech ManPower column continues with advice for job seekers
28-29 A DRAUGHT OF DESIGN EXCELLENCE EXPO stalwart Boddingtons lifts the lid on its award winning designs in plastics
41 MONEY FOR MED-TECH Dr Gugs Lushai reports on the Precision Medicine challenge November/December 2015 ¦ 03
Med-Tech Innovation Med-Tech Innovation Expo 2016
Expo 2016
"The only 100% dedicated, medical design, innovation and manufacturing event for the industry"
20-21 April Ricoh Arena, Coventry UK
Countdown to Med-Tech EXPO 2016! Make a date for April 20-21st at the Ricoh Arena, Coventry. Colin Martin, show founder – previews this issue – and looks forward to EXPO 2016.
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ll of us have much to learn about the successful way the Irish med-tech sector has gone about its business over the past ten years. Our second look at the sector and our post-Med In Ireland review should hopefully give a few clues in these pages. We are delighted to be Enterprise Ireland’s media partner for this purpose and we look forward to exploring further initiatives with them through 2016. Now the focus turns to the UK and to our own EXPO 2016 event, at the Ricoh Arena, Coventry, April 20-21, 2016. The key thing for now is to get the date into next year’s diary and to make sure of your exhibition space. EXPO 2016 is the only UK med-tech show next year. Demand is therefore expected to be high. Now is the time to make certain of reaching your market via our various exhibition and pr packages. From my perspective, one of the best things about EXPO 2016 is the level of new business done there. We have many testimonials that we will be releasing to the market over the coming weeks. Here is Steve Gibson for example, sales director at cleanroom supplier, NGS. ‘We were extremely impressed at the professionalism of the event organisation and most importantly we were blown away by the quality of the visitors who attended our stand over the 2 days. As of now, only 6 months after the event, we have secured 2 large projects with companies we met there and we are at the advanced stages of negotiation with another contact made. We will definitely be exhibiting again in 2016.’ Our EXPO should be an integral part of your med-tech business year – year after year. Do join us in April and let us know your needs.
MTI EXPO 2016 details and floor plans are now available direct. Full particulars from Colin Martin. Email: colin.martin@medtechcomms.com www.med-techinnovation.com
November/December 2015 ¦ 5
Med-Tech Innovation Med In Ireland
Once again, the Med In Ireland event gave visitors a very warm welcome throughout the day at the National Convention Centre, Dublin – and then also through the evening at a special reception at the Guinness Brewery, St James Gate
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www.med-techinnovation.com
Med-Tech Innovation Med In Ireland
Med In Ireland exhibiting companies demonstrated a very wide variety of new products and capabilities at the October 29th event.
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November/December 2015 ÂŚ 7
Med-Tech Innovation Med In Ireland
From strength to further strength MTI Magazine interviews Brian O’Neill of Enterprise Ireland about the factors behind the latest Med In Ireland success Yet another successful MedinIreland event Brian? This was Enterprise Ireland’s 6th Med In Ireland and the feedback from all quarters has been incredible – international guests were bowled over by the event and our exhibitors were full of praise for the calibre of the overseas guests that attended. This year we had 70 companies and 16 of our key research centres exhibiting. There were 800 attendees in total, with 300 of these being carefully selected international buyers from 43 countries. The prearranged partnering meetings are a key activity; we had almost 1200 planned meetings with hundreds more occurring ad hoc on the day, as well as over 170 facility visits to exhibiting companies.
Many leading companies at the show paid tribute to Enterprise Ireland’s leadership qualities in taking the industry forward. What further measures and innovations might we except from EI? The MedTech sector is a very important sector for Ireland, employing over 25,000 people with exports of over €8.5bn annually. This output is delivered by over 350 MedTech companies, of which 60% are indigenous. Our focus over the coming years will be on driving scale across our start up community and ensuring our clients are really strengthening their global reach. Innovation will remain core and driving new, collaborative partnerships across the global stakeholder community will certainly be a priority – with offices in 31 countries, we are well placed to do this. We are continuing to strengthen the engagement between our public research system, our health system and industry. The nationalisation of our Health Innovation Hub is an exciting development, providing a front door access to our health system for industry while identifying and capturing new innovations from within the health system itself.
What are the elements that contribute to the growing dynamism of the Irish med-tech/ lifesciences ‘ecosystem’? In essence, we are always working together to make Ireland the best location in the world to design, develop and manufacture medical technologies. We foster strong linkages between academia, clinicians and the 8 ¦ November/December 2015
MNC, SME and Start up community. These range from support for early-stage research in research centres such as AMBER (Advanced Materials and Bioengineering Research) and APT (Advanced Polymer Technologies) to the BioInnovate programme, which addresses collaboration between academia, clinicians and industry in developing novel medical technologies and The HRB-CRCI (Health Research Board, Clinical Research Coordination Ireland) which provides centralised support for the conduct of multicentre clinical trials, both commercial and academic, across Ireland.
What else should we look out for in the growth of the sector and manufacturing in Ireland generally? We will see more world-leading companies emerge from the Irish system. Convergence of technology is also going to be very important and Ireland is well placed to drive next generation collaborations between our global leading ICT, Food, Pharma and Medtech systems. www.med-techinnovation.com
Inside the device that healed her heart is our relentless attention to detail.
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Med-Tech Innovation Med In Ireland
Nelipak keeps on track We talk here to Seán Egan, Group Marketing Manager, Nelipak Healthcare Packaging How was your Med In Ireland event Seán?
What is your sense of the Irish med-tech/lifesciences sector in general at this point?
Overall, the event was excellent. We had several productive scheduled meetings with companies looking to source our products, and then during the course of the day we opened up dialogue with several, visitors at our booth – which led in turn to additional unexpected business opportunities. While we felt numbers were down slightly on previous years, the right calibre of contacts were in attendance, with clear intent to do business.
Any particular company highlights? I took the opportunity to network with many of the other exhibitors, bringing them up to date on our activities – in particular, the fact that our Phoenix facility has attained ISO 13485, making us the only dedicated healthcare thermoformer with this accreditation in all our manufacturing locations. In the case of one exhibitor this led directly to a request to quote for a new project.
Positive sentiment continues to be strong in the sector here in Ireland. We continue to grow our business with companies on the island and see several new opportunities opening up next year, with both existing and new companies. Seán Egan, Group Marketing Manager
And other thoughts on development? We have expanded our reach with our five locations over the last year. This has been well received by our global customers who are looking for more strategic relationships with key suppliers. We continue to expand our service – offering complementary products around our core thermoformed clea nroom tray, with lids, pouches, cartons and die cards.
IMR develops the focus Coordinated research is key to the success of the manufacturing supply chain in Ireland. We talked to Barry Kennedy, CEO of newly formed Irish Manufacturing Research (IMR) How was your Med In Ireland event Barry? There was a impressive amount of Med-Tech companies displaying and attending the event. Actually it is only when you see the size of the convention centre and the numbers of companies that have a significant presence in Ireland, that you realise the health and vibrancy of this industry in Ireland
Any particular company highlights to mention? From Irish Manufacturing Research’s perspective we were delighted with the interest the med-tech companies in Ireland showed towards us – our plans and ambitions.
Plans and issues for the company in the coming year? Irish Manufacturing Research is scaling up its operation through 2016. We will be moving into our new offices, developing our collaborative research & innovation space and hiring highly skilled research engineers in the areas 10 ¦ November/December 2015
of Analytics, Optimisation, System Integration, Additive Manufacturing and a whole list of other skills, primarily in order to service the research need for Factory 4.0 - the factory of the future. In partnership with cross sectoral manufacturers in Ireland and in Irish academia we are excited about the opportunities to jointly solve manufacturing challenges for our companies.
Your sense of the Irish med-tech/lifesciences sector in general at this point? Currently very healthy - not just for the main or larger med-tech companies - but also for the sub supply base that services these businesses. However we cannot afford to stand still and be satisfied with our lot, we need to continue to drive through and deliver global leadership - and not just with the products we make but also in the way we do it. Other regions in the world are driving this agenda and we need get ahead and stay ahead to maintain leadership in productivity and efficiency. www.med-techinnovation.com
Med-Tech Innovation Med In Ireland
VistaMed – ever broadening horizons MTI Magazine talks to VistaMed owner and director Paddy Mulholland about the ever-present growth at the company How was your Med In Ireland event Paddy? Med In Ireland is undoubtedly the best show in terms of presenting live opportunities to Irish companies and engaging with a captive audience. Enterprise Ireland has done a stellar job in the organisation of this event and continues to get very positive comments from both visitors and participants. This is a unique event and one which we hope is continued into the future.
Any particular company highlights to mention? The format of the 20 minute business meetings is very useful, as it concentrates the minds of both parties to focus on what we can offer each other. The networking event in the Guinness Storehouse was also useful as a catchall for some additional contacts that we wanted to meet. Apart from the fantastic business networking opportunities at the event, we were able to link this with the opportunity to get customers to visit our facility and demonstrate our capabilities, which proved to be a tremendous benefit.
Your sense of the Irish med-tech/lifesciences sector in general at this point?
VistaMed owner and director Paddy Mulholland
equipment, which was necessary to meet the demand for smaller, minimally invasive catheters, and we have used our extensive knowledge of polymers, braiding, coils and assembly techniques to optimise functional characteristics, such as torque strength and kink resistance.
It would appear that the Irish med-tech sector is experiencing buoyancy and growth with all companies optimistic about growth prospects. This growth can in some cases be frustrated by the shortage and availability of skilled and experienced staff to sustain the growth opportunities. Fortunately the third level institutions have responded in providing relevant courses to service the industry which should maintain Ireland’s reputation as an international contender in the Med-tech sector.
What’s new for next year?
Any other upcoming company positives to mention?
And for VistaMed manufacturing?
VistaMed has enjoyed dramatic growth over the last four years and now employs over 300 staff. We find that our offering of innovative solutions, fast development cycles and high quality has led to many Irish and foreign medical companies availing themselves of our services in developing and manufacturing a diverse range of catheters and medical devices. In order to maintain and improve our offering, our strategy is to be vertically integrated and to leverage our expertise in extrusion in ever more complex and challenging products. We have invested heavily in our extrusion department with state-of-the-art extrusion www.med-techinnovation.com
VistaMed will be opening a new Development Centre in Carrick-on-Shannon discrete from the manufacturing plants in 2016. The development centre will be fully equipped to manufacture early-stage catheter designs. Our aim is not only to complete joint development programs but also, based on the project goals and inputs agreed with the customer, VistaMed will solely fully develop catheters including design files, regulatory submissions, registration, and clinical trials, where necessary.
Using the Lean system, developed by our Joint Venture partner, Freudenberg Medical - unrivalled within Medical Device companies - we have developed a Road Map for the future. A full-time Lean leader, assisted by an increasing number of Green Belt practitioners, will help us to accelerate down this path. The shop floor staff are excited by the opportunities to learn these techniques and improve quality and productivity. We also have planning approval to double our manufacturing space in Carrick-on-Shannon. Recruiting over 100 staff in the last 12 months, we plan to provide further employment to the area as we expand both our development and our manufacturing. November/December 2015 ¦ 11
Med-Tech Innovation Plastics
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Med-Tech Innovation Med In Ireland
Better by Design! The best of Irish Med-Tech Design was to the fore at Med In Ireland, in the form of stand alone exhibits and with the presence of leading Irish consultancy firms. MTI magazine chatted with both Dolmen and Design Partners through the day. Frances Mitchell of Dolmen said: ‘We have exhibited at Med in Ireland since its inception and are very excited about being here today, busy with our one-to-one meetings. The exemplary work done by the teams in Enterprise Ireland and the IDA in conjunction with companies in the industry sector means that we are looking forward to a very high quality of attendees.’ Dolmen now has 24 years experience of helping creating leading designs and products for its clients. CEO, Sean McNulty, gave a workshop during the morning session showing how the application of the company’s Discovery process added significant value to their clients’ bottom line. Eugene Canavan of Design Partners reflected that ‘Med In Ireland was again excellent - the event was extremely well run and the attendee’s created an atmosphere of excitement and positivity regarding the future of healthcare worldwide as well as the continuing growth and success of Ireland in this sector. I also thought the Design and Innovation sessions were a welcome addition to the event: the power of design and design-thinking is increasingly understood in this sector.’
Frances Mitchell and Sean McNulty of Dolmen
Eugene Canavan of Design Partners
Canavan’s view is that ‘increasingly, healthcare companies are looking to take their product solutions to a new level, to provide better results for patients and healthcare professionals, and also in response to commercial realities and to gain competitive advantage.’ Design Partners opened a new facility in July 2013 which now allows the company to carry out product development and R and D in a way ‘that is lean and holistic,’ according to Canavan. ‘Our goal of delivering complete user experiences means we will continue to invest in our multi-disciplinary team and the engineering of the product solutions we provide. With this in mind we plan to grow our team by some 15 to 20% next year.’
Seabrook rides the wave Seabrook Technology Group used the morning of the Med In Ireland event to sign a channel partnership agreement with Siemens PLM Software for Ireland and UK – all in the company of the Taioseach, Enda Kenny. The new partnership enables Seabrook to offer Siemens’ de facto standard PLM (Product Life Cycle Management) software to its new and existing clients in Ireland and in the UK, and is expected to generate revenue of over €1 million euros in the first year to eighteen months for Seabrook. It will also lead to the creation of eight new high-level jobs, six at its Cork offices and two in the UK. Seabrook has been operating in Ireland for 26 years, and over the past three years the company has tripled its workforce and has expanded into the US, with offices in California and Indiana. Seabrook works with numerous multi-national and indigenous firms in the pharmaceutical and medical devices industry, including Zimmer Biomet, Stryker, Zoll Medical, Abbott, Biotronix, Carl Zeiss Meditec, Pfizer, and Thermo Fisher Scientific. The new PLM offering will ensure improved traceability of products and will have an immediate and positive effect for the consumer or product end-user. www.med-techinnovation.com
Sean O’Sullivan, Managing Director of Seabrook Technology Group, pictured with An Taoiseach, Enda Kenny, and Robin Hancock, VP and UK Managing Director, Siemens Industry Software, at the Med In Ireland launch of Seabrook’s partnership with Siemens Industry Software in Ireland and the UK.
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Med-Tech Innovation Med In Ireland
The best of the best… By the time our issue goes to the print the winner of the Medtech Company of the Year at the Irish Medtech Excellence Awards will have been revealed. Here we profile the four chosen contenders – the shortlist itself showing the strength-in-depth of the industry in Ireland.
Abbott Diagnostics, Longford Abbott Diagnostics, Longford established its manufacturing facility in 2004 on a 20 acre greenfield site on the outskirts of the town. The 135,000 square feet building was specifically designed to allow the most efficient flow of product through the value stream from raw material receipt to finish goods shipment. Manufacturing commenced in March 2005 and the first product was shipped in December 2005. There are over 250 employees on site, designing, developing and manufacturing in-vitro diagnostic products; a total of seventeen different diagnostic reagents as well as calibrators and controls. John Conlon, Operations Manager at Abbott Diagnostics, Longford, says that the 2015 shortlisting ‘is testament to the fantastic work that our employees continue to do every day at our facility. Innovation and change are inevitable in our industry and we need to constantly improve our manufacturing processes and business systems to meet evolving healthcare system and patient needs. In terms of the wow factor – we have a culture of sharing across our own company, internally at the site, with our customers, the community and with our peer medtech companies. Through the success of this project we have developed a very strong ‘visual factory’ with a highly engaged workforce – and this comes across when we have visitors.’ Conlon adds that ‘as part of our internal project known as ‘Becoming World Class,’ we are enabling long-term innovation to happen whilst also fostering a culture of continuous improvement and growth. We are on a constant journey of change as a team, one that has now enabled us to challenge for the Shingo Prize – an award dubbed the ‘Nobel Prize for Manufacturing’ and one that truly is recognition of world class performance.’
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Boston Scientific Boston Scientific’s Roadrunner programme has put the business in line for Ireland’s Medtech company of the year. The initiative consists of a small startup team within Boston Scientific Galway, working with key doctors on what they need in the changing field of endoscopy; rapidly testing concepts and ideas, and quickly commercialising the appropriate products, all the time existing within the wider boundaries of a corporate structure. The Roadrunner team has strengthened Boston Scientific’s endoscopy stent leadership position by commercialising attractive niche opportunities, expanding the product portfolio, identifying opportunities to accelerate product life cycles, and innovating with key customers to identify unmet needs. Kurt Geitz, VP of R&D, Endoscopy Division, represents Boston Scientific on awards night and says that ‘we are delighted that the Boston Scientific Endoscopy Roadrunner programme has been recognised within the wider medtech community. Roadrunner has been an exciting journey. We assembled a small team to think and act like a startup company while enjoying the benefits of operating within the wider boundaries of a corporate structure. Being selected for the shortlist has reinforced our vision of the Roadrunner programme and how we add value to the customers and patients.’ Geitz adds that ‘one of our core values is meaningful innovation – getting breakthrough for services and solutions that create value for patients, customers and employees. Our global marketplace for medical devices is in an accelerated rate of change. Boston Scientific therefore fosters a culture of innovation that expands throughout the organization in order to sustain long-term growth.’
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Med-Tech Innovation Med In Ireland
Stryker
Tech Group
Stryker established its presence in Ireland in 1998 and over the last 16 years has built significant research and development competencies and continued to expand its manufacturing operations. Stryker Ireland currently employs over 2,000 people at four sites in Cork and Limerick. Stryker product lines in Ireland include: minimallyinvasive neurovascular products to treat vascular diseases of the brain; powered instruments for neuro and orthopadic surgery; orthopaedic implants; and synthetic Biomaterials. A state of the art surgical Innovation Centre has been established by the company in Cork and a biomaterials R&D group has been established at Stryker’s Limerick facility The focus of the Limerick-based R&D group is the development of next generation cements and biomedical solutions in the areas of Craniomaxillofacial, Othhopaedic, Neuro, Spine and ENT surgery. Stryker’s R&D success has typically been underpinned by strong research partnerships, developed over many years with the National University of Ireland Galway, University College Dublin, University of Limerick, Tyndall National Institute Cork, Cork Institute of Technology and with University College Cork. Aidan O’Shea, Vice President, Ireland Operations, will represent the company on December 10th in Dublin. He says; ‘We are thrilled to be shortlisted by the Irish Medical Device Association for Medtech Company of the year, and honoured to be among such a prestigious group of finalists. Stryker has a long and successful track record in Ireland. We believe that this award is a recognition of the company’s continuing investment in manufacturing operations as well as for the introduction of innovative technologies and products, particularly in the past year.’
The Tech Group, part of West Pharmaceutical Services, Inc., is a process-driven, global contract manufacturer of pharmaceutical and medical devices and diagnostics. Since 1998, Tech Group Europe Limited (TGE) – Dublin-located – has been supporting the device requirements of its pharmaceutical and medtech customers. TGE also offers development and engineering support from concept through to high-volume manufacturing. The combined capabilities and expertise of West and The Tech Group have created one of the world’s leading manufacturers of pharmaceutical delivery systems, medical devices and components. Tom Clarke, Site Director, Tech Group Europe, will be hoping to pick up the prize for the company on the night. ‘2015 was a transformational year for TGE,’ he says, ‘as a number of key strategic milestones were achieved - most notably commercialisation of three major device programs, attainment of our drug handling licence, and acknowledgement of employee development initiatives through Investors in People (IiP) GOLD accreditation. Clarke adds that ‘on November 16th 2015, we began construction on a new 65,000 sq. ft. building to accommodate new business. We also broke ground that month on a new site in Waterford that will produce packaging components for insulin injector cartridges and other high-value packaging components.’ Clarke says that ‘being selected as a finalist recognises the commitment and innovation of TGE employees and our colleagues around the world who have supported our growth journey. These are exciting times for us at TGE as we continue to evolve and execute on our vision to create a healthier world.’
www.med-techinnovation.com
November/December 2015 ¦ 15
Med-Tech Innovation Injection Moulding
On the upward Trend MTI Magazine took notes at the show from Brendan Murtagh, Business Development Manager at leading Irish injection moulder, Trend Technologies
T
rend Technologies’ participation at this year’s Med In Ireland proved to be a great success yet again. Our one-to-one meeting schedule with potential and existing customers was completely full - and networking continued long into the evening. This year, for the first time, we had our new German Region representative Thorsten Boteljann on our stand, and this added a new dimension to the event for us. The Med In Ireland event gives Trend the opportunity to showcase the kinds of medical technology projects that we are working on, and to highlight just how we provide real value to our customers in that sector. The core business of Trend Technologies is the manufacturing of complex plastic injection moulded components and sub-assemblies, but the real key to the company’s success is in the delivery of related services – in particular those services that relate to New Product Introduction. What Trend’s ‘value statement’ says in relation to that real value is: “Our superior project management processes and techniques will ensure delivery of every project on time and within budget, resulting in our customers achieving the fastest possible time to market for their new product, and doing so with the lowest possible level of risk” For many of the visitors attending MedinIreland, Trend’s core competence in the area of NPI is exactly why they want to meet with our team. Many visitors to our stand already knew that we offer best-in-class tooling solutions, project management, product validation and manufacturing services. As further evidence of that, Trend was shortlisted this year for Plastics Processor of the Year, at the British Plastics Industries Awards ceremony recently held in London. We did not win this year, but we will be back again next year at this prestigious event - fighting for the coveted prize - as it is our clear objective to be endorsed as the injection moulder of choice in the UK and Ireland. And speaking of awards & recognition, on November 13th, four of our team attended the Awards dinner of the Irish Exporters Association and this time came away with first place, winning the medium-sized company Exporter 16 ¦ November/December 2015
of the Year Award 2015. Over 500 guests, government ministers, TD’s and senators attended the event, and Trend had to beat off competition from over 70 entries to win the prestigious award, which was presented by Tom Rea, Executive Director of Guaranteed Irish. Speaking at the Awards Ceremony, Hugh Kelly, President of the Irish Exporters Association said: ‘The Irish Exporters Association Annual Awards are so important because they acknowledge and celebrate the achievements of the most important sector in Ireland’s economy. The unwavering commitment of our exporters to delivering world-class customer service and solutions has played a significant role in our economic recovery.’ In the last four years Trend Technologies export sales have doubled, and they now stand at 60% of total turnover. That growth is driven by our success in delivering real value and exceptional service to our customers, and it is a credit to the commitment and talent of the team here in Mullingar. During 2016, Trend will focus strongly on projects within the Medical Technology sector, with particular focus now on the UK & German markets. There are plans in the pipeline to expand our cleanroom manufacturing space, and there will be some significant new marketing initiatives happening early in the New Year. Our R&D team will also be actively involved in the Industry 4.0 project just launched under the leadership of Andrew Lynch at Irish Manufacturing Research (IMR). This project will tie in well with Trend’s plans to significantly expand our R&D capability at the Mullingar site through 2016.
From the 2015 Irish Exporters Awards Dinner last month. On left Minister of State Tom Hayes, then Justin Wallace, Trend Technologies, Tom Rea, Executive Director of Guaranteed Irish, and Hugh Kelly President of the Irish Exporters Association.
www.med-techinnovation.com
Med-Tech Innovation
Medical Packaging
Custom packaging solutions that provide superior quality and protection
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November/December 2015 ÂŚ 17
Med-Tech Innovation Electronics
Anecto – riding a ‘perfect storm’ MTI magazine caught up with Anecto sales director Michael Connolly at the show and discovered how the Galway-based test laboratory is now preparing for even more growth.
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necto is in a better position than most to understand why Ireland has lately become the European hub of the medical device industry. Anecto’s beginnings in 1994 as an electronics test house saw the company then quickly expand to serve the wider med-tech market; offering a comprehensive suite of tests for medical devices and medical packaging as well as continuing in electronics. The continued development of the medical device sector, coupled with the rapid rise of combination products and the blurring of the lines between med-tech and pharma, all helped fuel the Anecto expansion and further the company’s growing IP, services and sales. The Irish government’s lead was critical in developing the sector. In 2007 the National Development Plan pledged €8.2 billion for scientific research up to 2013. 2014/15 did not, however, see an end to these substantial investments. Most recently the government continued this push with a €300 million joint investment, with industry partners in seven world-class research centres around the country. Add to this Ireland’s low corporate tax rate, and the country becomes a very attractive prospect to the big players in medical devices. One of the things that attracts these ‘big players’ to Ireland is what Anecto Sales Director Michael Connolly describes as “the perfect storm”…absolutely the right market size and conditions to foster and reward the knowledge and expertise – and development across the board for supply companies. And for Anecto that has meant the supply of expert and reliable consultancy, together with all manner of relevant testing services.’ Connolly recalls that ‘when the internationals first came here they were largely American and British. As well as the tax incentives, they had a hard-working and well
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educated English-speaking workforce at their disposal. And, as the numbers of med-tech internationals coming to Ireland began increasing, so did their R&D and manufacturing operations. In line with that, the expertise of our workforce grew and - by osmosis - so did the general infrastructure and services such as suppliers and independent contractors.’ Connolly notes that ‘Anecto came up on the tide with all of these developments. We also made sure to take our opportunities to grow our expertise, our IP, and to find testing solutions to problems all across the medical device field. Outside of Ireland it is now difficult, if not impossible, to find such a varied and concentrated wealth of experience.’ Anecto also realised some time ago that the early attractions of the English language might form a false comfort zone. ‘Any European company,’ he says, ‘who does not do business with mainland Europe is in danger of making themselves irrelevant.’ Accordingly, and over a decade ago, Anecto started building close links with Europe’s major medical device hubs. Anecto now includes German, French, Spanish and Italian speakers on its staff as well as active representation in five countries. One clear and major advantage from this cultural and linguistic cross-fertilisation was the resultant depth of regulatory knowledge at Anecto – coupled with consultancy and testing expertise. ‘As a result of these moves we believe that Anecto now offers the most comprehensive suite of tests in Europe for medical device companies. The proof of the pudding is in the eating. According to Connolly, ‘We work with over 85% of the global Top 20 medical device companies. The level of expertise offered across the board from one location is a very attractive prospect to our European clients. And long may it continue!’
www.med-techinnovation.com
Med-Tech Innovation Design
Grappling with the human design Visitors to EXPO 2015 will be familiar with the abilities and offerings from the pd-m consultancy. Pd-m Director Richard Hall will set to start a new column in this magazine on med-tech design matters.
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lthough pd-m celebrates its 10th birthday this year, and has an impressive slew of med-tech design successes under its belt, the company continues to stick with the mantra that ‘you’re only as good as your last job’. Director Richard Hall says: ‘Service is key in today’s design world. Most consultancies worth their salt work primarily on referrals and repeat business, and these companies typically get the work because of a conscientious and multi-disciplined approach to their work.’ About 70% of pd-m’s work is currently in the med-tech area. Hall points out that the sector is not for the faint-hearted. ‘Not only do we have to work with the client and for the client,’ says Hall, ‘we often have to reach through the client, so to speak, in order to access the patient and the real-world problems and issues that patients face. And let there be no doubt – if the patient can entertain the faintest doubt about the client’s new product – then it will fail. Our job from the outset is to whittle away any and all areas of potential future failure.’ Hall adds; ‘No matter the intention, new med-tech and healthcare products only get one shot at success. Painstaking field research and further research is mandatory for any chance of newproduct acceptance or success. ‘After all,’ notes Hall, ‘we are typically involved in the most private and intimate connections of patients with their bodies.’ And bodies and experience vary – from person to person. For example, Hall relates how – when designing a radical new obstetrics forceps for baby delivery – a series of tests (on physicians) were performed at St James’s University Hospital, measuring a variety of doctors according to the typical force they applied to the baby delivery procedure. ‘The variations in force, I have to say, were much wider than expected!’ And so, not only was this research
Pd-m Director Richard Hall
invaluable in designing the new obstetrics tool itself, it also helped set the context of usage – and a new benchmark and guidelines for the doctors using the product. Hall’s view is that the standard pregnancy testing kit has yet to be bettered for illustrating med-tech design success. ‘It successfully negotiates an intimate and delicate space,’ says Hall, ‘and it also delivers results of absolute certainty. In truth that is the condition to which all medical devices must aspire – and it’s much, much easier said than done.’ Most medical and healthcare products need to be failsafe and absolute. That is to say, they must be trusted absolutely – in use by the patient and in the results provided. Anything less spells commercial disaster. Hall’s career as an industrial designer has been built from the ground up, from a foundation in the 1980s at Rolls Royce Engineering (Apprentice of the Year) through various design functions and companies, to his own business consultancy, a duty concurrent with a role as mentor with the Design Council. The latter has seen him work primarily under the Spark programme, and he has lately overseen one of the winning teams into the final stages, fast-tracking innovative products to market. Up to four winners will be chosen to receive special Spark Awards, getting a share of £150,000 additional funding. In the design-based articles to come for MTI magazine, Richard and pd-m will focus on a number of sectoral topics and considerations; for example, working with doctors and surgeons on new products; handling the manufacturing supply chain.
‘Not only do we have to work with and for the client, we often have to reach through the client in order to access the real-world problems and issues.
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November/December 2015 ¦ 19
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Med-Tech Innovation Plastics
Thermoforming for med-tech Established moulder CWP was on the grid for this year’s Compamed 2015. Adrian Lunney visited the Wokingham plant to find out how the company’s plastics thermoforming business is shaping up for medical and healthcare markets.
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ndy McGarry, CWP Managing Director, is currently presiding over a period of business expansion at the company. He notes that, unlike some other processes, ‘the plastics thermoforming route offers clients the opportunity for very fast and very bespoke design, together with low volume production.’ ISO-certified CWP designs and makes all such tools and ‘the relative cost is very affordable. Plastic thermoforming traditionally offers great opportunity and scope for competitively-priced large part production - something that is always required for all sectors and industries, including med-tech.’ The OEM production of MRI body scanners, for example, may be limited to a few machines each month. Nonetheless the MRI equipment still needs to be fitted out with functioning parts such as cowlings, hoods and so forth, all ideally sourced and provided at optimum cost. ‘Here,’ says McGarry, ‘is where a quality-based thermoforming producer can be an essential partner in the production A thermoformed baby crib from mix.’ CWP, typically McGarry also notes that the used in postmed-tech environment – ‘the world natal hospital of the typical hospital’ – has a environments multitude of product needs that CWP thermoforming can satisfy. ‘Lids, housings, containers, bedside fixtures and fittings, trolley, theatre equipment…the list and the opportunities here are almost endless. This year sees us step up our medtech campaign in earnest and our Compamed showing is a key part of that.’ 2016 will see clear expansion on all fronts: new investment has arrived in recent months in the form of the latest Maka 5 axis CNC machining technology – accounting for a £180,000 spend – and boosting capability in this area by some 15%. A new pressure-forming vacuum machine, a Geiss T10, will be installed and commissioned in March 2016. www.med-techinnovation.com
This pressure-forming asset will further enhance CWP’s abilities to produce different aesthetic finishes to the fascias of products. The latest press investment will also bring the CWP thermoforming fleet to a total of nine machines– all Geiss except for one large-platen Cannon machine, capable of producing parts up to 3000mm x 1500mm. A thermoformed knee rest – for New personnel have also been recruited to take the use in lower back company’s ambitions forward. Steve Brett, the newly treatment and arrived Operations Director, is taking production knowrehabilitation how into the next era at CWP. His background includes telecoms and blue-chip manufacturing, Continuous Improvement (CI) and other operational disciplines, which will be factored into the new manufacturing methods at the company. A current total of four CWP manufacturing apprentices – in a total workforce of 50 people – are being trained through the system. The high complement of apprentices speaks volumes about CWP’s confidence in its manufacturing future. Sales and marketing also sees renewed investment. Helen Wilde, for example, has recently joined the company to further CWP’s new business development. Helen’s extensive industrial experience includes engineering, tooling, rapid prototyping and the growing additive manufacturing sector. She says that ‘CWP’s product offering is extensive, the experience of our team is second to none and we are very well placed to expand into new markets, such as med-tech, that require very large vacuum formings.’ All in all, the CWP future looks bright. Compamed 2015 looks likely to deliver a good number of enquiries and orders that will give the company Hot off the press – a base moulding that will become a bathing product for use in traction to Compamed 2016 and geriatric care… beyond. November/December 2015 ¦ 21
Med-Tech Innovation Imaging Technology
Real-time relief for cancer sufferers Seed funding from SBRI Healthcare has enabled new company Lightpoint Medical to develop a proprietary molecular imaging technology with the potential to detect cancer in real-time during surgery, and thereby reduce the need for re-operation.
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he new company is dedicated to improving health outcomes for cancer patients through margin assessment and image-guided surgery. Lightpoint helps doctors to ensure that they have identified all cancerous tissue. It helps patients by limiting the recurrence of cancer and has potential savings of £28m for the NHS. The SBRI funding for the company was awarded under the competition: Better health outcomes: research tools. Phase one award was £96,600. Phase two was awarded at £947,120. Cancer frequently requires multiple operations. For example, 2040% of breast cancer patients who undergo breast-conserving surgery will require a re-operation. The consequences, in addition to the repeat operation itself, include delayed follow up treatment, higher risk of mastectomy, increased likelihood of recurrence, poorer functional and cosmetic outcomes, patient anxiety, and enormous financial cost. Cancerous tissue often fails to be
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Lightpoint is expecting to release its first commercial product towards the end of 2015 and a second product in 2016. The team is rapidly growing from three in 2014 to a team of 15 in May 2015. Revenue for Lightpoint Medical is expected to double year over year for the next three years.
completely removed during the initial operation because there are no tools to rapidly and effectively detect cancer during surgery. Today, surgeons primarily rely on visual and tactile assessment to find An impression of the Lightpoint microscopic cancerous deposits. Medical imaging Consequently, there is a tremendous system medical need for improved tools to image cancerous tissue in real time during the operation. The Lightpoint technology is based on Cerenkov Luminescence Imaging (CLI), a ground-breaking imaging modality that can perform optical imaging of Positron Emission Tomography (PET) agents. CLI combines the benefits of optical imaging (namely, low cost, high resolution, and portability) with the power of PET imaging (high diagnostic performance, and widespread availability of imaging agents). Relative to competing technologies, CLI has the potential for greater diagnostic performance across a broader range of indications, without the need for developing novel contrast agents. CLI is roughly 100 times cheaper than a whole-body PET scanner. Lightpoint Medical is developing engineering solutions to make CLI feasible for routine clinical use. There is significant benefit for patients if the operation succeeds in removing all cancerous tissue first time round. The outcomes will be better for them and they will not have to suffer the distress of repeat operations. www.med-techinnovation.com
Med-Tech Innovation
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November/December 2015 ÂŚ 23
Med-Tech Innovation Smart Technology
Taking the pressure off Diabetes continues to afflict growing numbers of the global population, affecting more than 347 million people worldwide. In England alone, the treatment of diabetic foot conditions is estimated to cost the NHS £600m a year, with over 7,000 mostly preventable amputations per year.
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p to 70 percent of diabetic patients will suffer some form of neuropathy (loss of feeling) in their feet, and up to 25 percent will develop a diabetic foot ulcer. In the UK, amputation occurs in about 1 in 1,000 diabetes patients. Against this background the Glasgow-based bioengineering company HCi Viocare Technologies has developed a Smart Insole that monitors diabetic feet at risk of ulcers and amputation. The Smart Insole helps diabetics make informed decisions about the levels of activity that are appropriate for them, so that they can do what they love, but also safeguard the health of their feet. The smart insole, which fits inside a normal shoe, uses a multitude of tiny sensors to detect pressure across the foot and can alert the user’s smart phone if they are engaging in behavior that increases their risk of developing an ulcer. The company is also adapting its own sensor technology to be used in Smart Mattresses and Smart Wheelchair Cushions, designed to avoid debilitating pressure sores, and allowing patients and care givers more control over their lives. The technology works by using a network of tiny electronic sensors to send data back to a smart device or mobile for real-time feedback or for later analysis. The mattress and wheelchair cushion will use the electronic sensors to monitor potentially harmful pressure and shear forces among bedridden or wheelchair-using patients. Real-time feedback from the sensors prompts the mattress or cushion to automatically adjust so that the patient is repositioned to help prevent ulcers forming. The revolutionary innovation in HCI Viocare’s platform technology is the shear sensor, which measures the ‘squashing’, rather than rubbing, of skin, and the ability to
24 ¦ November/December 2015
measure these forces at affordable cost. The battle to prevent pressure ulcers, an injury where the skin and underlying tissue break down, is largely a pre-emptive one, taking action before the ulcer has a chance to form. Pressure ulcers can have a profound effect on the patient, ranging from mild discomfort to severe pain. Pressure ulcers affect around 20% of people in hospital across Europe and can affect anyone who is immobile or unable to feel the pain and discomfort that results from sitting or lying too long in one position. Pressure ulcers are also estimated to cost the health care systems in Europe up to 4% of their annual budgets. HCi Viocare is now in discussions with several partners who have shown significant interest in incorporating the new technology into their products and in producing the company’s new inventions. Dr Christos Kapatos, HCi Viocare’s chief technical officer says ‘we were delighted with the rapid and highly positive response to our Smart Insole invention – a reaction that has led us to expand our range of innovations. We are now moving forward with new applications for our core technology, and continue to seek new partners who wish to commercialise this next generation of health products.’ Christos also commented that ‘we are in discussions with relevant partners about the new products, validating our licensing model and encouraging us to find novel uses for our proprietary technology.’ HCi Viocare Technologies is a Glasgow-based subsidiary of HCi Viocare which has a dual business model: firstly creating the first cross-border independent chain of Prosthetics & Orthotics (P&O) and Diabetic Foot clinics in Europe and the Middle East; and secondly, developing a portfolio of biomedical technologies in these areas, addressing unmet needs in the diabetic foot, P&O and other health & wellbeing sectors. HCi Viocare has its executive office in Athens, Greece and its R&D centre in Glasgow, UK. www.med-techinnovation.com
Med-Tech Innovation Wellbeing
WMAHSN leads on elderly care The growing demographic of elderly in the world demands custom-made and standardised structures and instruments through which effective healthcare and med-tech can take place. Last month the West Midlands Academic Health Science Network hosted a special international two day meeting on the topic.
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he central topic was the EASYCare project, its local implementation and the vision of a world with an engaged, independent and empowered older population. The EASYCare instrument is a nationally accredited, evidencebased assessment tool used to systematically identify and respond to unmet health and care needs of older people in a practical and reliable way. It consists of 49 items covering seven key domains about physical health, social care needs and mental wellbeing concerns. Underpinned by 25 years of research which continues to be integral to the work of EASYCare, the project is achieving widespread use in practice, as EASYCare information obtained about population needs can be used to develop and promote better care services for older people. The special meeting took place in Solihull and was led by Professor Ian Philp CBE, Deputy Medical Director for Elderly Care at Heart of England NHS Foundation Trust and former national Tsar for older people.
West Bromwichbased Counterplas exhibited these bathroom products for assisted/elderly living at MTI EXPO 2015.
Delegates look through supporting materials at the EASYCare conference
www.med-techinnovation.com
Professor Ian Philp, Deputy Medical Director for Older People’s Care at Heart of England NHS Foundation Trust takes to the floor to speak at the EASYCare conference.
As well as providing an overview of EASYCare, the meeting sessions included an expert panel session focusing on the development of local approaches for the challenge of supporting an ageing population, and exploring how this could involve the wider business community. This will was further supported by a “World Café” event, enabling delegates to share their advice and experience in promoting the health, independence and wellbeing of older people. Delegates also reviewed how EASYCare was being piloted in the Solihull area and discussed further opportunities. EASYCare network members from all six World Health Organization regions attended, including the African region (Uganda), the Americas (Brazil, USA and Costa Rica), South-East Asia (India), Europe (the Netherlands, Poland, Switzerland and Turkey), the Eastern Mediterranean region (Iran), and the Western Pacific region (China), as well as local acute trust, community trust, primary care, mental health and council staff and community members. Professor Ian Philp noted that ‘most older people continue to contribute to their communities and family life, adding value to society. However, with ageing, threats to health, independence and wellbeing emerge. If these are ignored, unnecessary dependency is created, leading to higher costs to families and society and reduced quality of life in old age. Philp added that ‘the EASYCare project addresses this challenge by promoting widespread use of the EASYCare Instrument and the flexible, person-centred approach that surrounds its adaptation for use in a variety of settings, including training, guidance, information systems development and impact assessment. However, the EASYCare approach reaches beyond the use of this assessment tool to encompass a range of guiding principles aimed to help introduce and embed the person-centred approach, ensuring that an appropriate system of care and follow-up surrounds the use of the assessment tool.’ November/December 2015 ¦ 25
Med-Tech Innovation Mammography
MARIA gets set to launch
Bristol-University spin-out Micrima, is set to launch its breast cancer screening system, MARIA, into the marketplace. Peter Bannister, Micrima’s Chief Technology Officer, outlines the innovation.
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reast cancer is the most common cause of death in women between the ages of 35 and 55 in Europe, and the leading cause of death in many countries. Early diagnosis dramatically improves survival rates, yet most tumours are not discovered early enough in part due to the difficulty in discriminating between cancers and dense (as opposed to fatty) tissue found in younger women. Screening programs utilise X-ray mammography (XRM), with ultrasound, MRI and biopsies used as follow-up diagnostics in the event that XRM identifies suspicious lesions. If diagnosed early, 5-year survival rates are excellent. However despite screening programmes being in place for many years, breast cancer mortality remains unacceptably high. In the USA alone, $6bn is spent on mammography and biopsy procedures where only a small proportion of the patients have cancer. Conversely, around 20% of cancers are missed, mostly where dense tissue is present. Micrima’s MARIA (Multistatic Array processing for Radiowave Image Acquisition) radiowave breast imaging technology has a number of key advantages for the diagnosis and screening of breast cancer: MARIA is accurate in dense tissue, the technology is very low dose (less than a mobile phone call), making repeated scanning safe, and the system is far more comfortable for the patient than XRM. MARIA measures very different physical parameters to those exploited by XRM and is hence able to provide new diagnostic information. The patient interface comprises an array of 60 antennas located beneath a form-fitting ceramic bowl and radiowave signals are combined to
26 ¦ November/December 2015
The M5 MARIA system, showing the Signal and Data Processing cabinet and patient bed. The patient lies with their breast pendulous though the hole in the bed, thereby avoiding the uncomfortable breast compression associated with X-ray mammography.
produce a high-resolution, 3D. The imaging process has been reduced to less than a 2 minute scan that detects tumours as small as 4mm under laboratory conditions. The MARIA system received European regulatory approval in 2015 and is currently deployed in clinical trials based at several breast cancer imaging centres throughout the UK. As of November 2015, MARIA has been used on over 200 patients in a clinical trial setting and on over 400 women in total of all ages. Both patient and clinician feedback has been very positive. The scanning process itself is quick and simple, and many women have volunteered feedback on how gentle the process is compared with XRM’s breast compression. In the lead-up to a full commercial launch, Micrima’s research and development team will continue to deliver a program of successive upgrades to the system encompassing both hardware and software. These improvements will accomplish the dual aims of increasing the utility of the technology by means of improved signal processing, feature discrimination (to achieve the necessary specificity for routine screening) and feature detection, while also driving down the size, weight & manufacturing cost of the system. Delivery of the technology is ultimately envisaged as a small format, portable system for general screening for breast cancer in hospitals, diagnostic and health screening centres, mobile screening units, GP surgeries and also in High Street locations. This low cost system will be designed for maximum ease-of-use, to put breast screening alongside other diagnostic tests currently found in pharmacy and ophthalmic outlets. www.med-techinnovation.com
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Med-Tech Innovation Plastics
Boddingtons hat-trick Last month MTI EXPO stalwart Boddingtons celebrated winning the Plastics Industry Product Design Award for the third year in a row. Two of the three winning designs were in the med-tech zone. Adrian Lunney took a trip to the Boddingtons factory in Marden, Kent to audit the secrets of the company’s med-tech design and manufacturing success.
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ack in the depths of the 2008 global recession – this particular part of the Garden of England did not look quite so favoured. Boddington’s general trade moulding markets were proving to be very vulnerable to the boom-bust cycle in manufacturing. Owner Rubicon brought in Andy Tibbs – an experienced Managing Director, whose cv demonstrates a history of turning companies around and developing strategies to deliver strong growth to organisations within the plastics sector. Tibbs began work in 2009 and a few months later brought in Keith Lawson, who knew the industry well. Lawson had also run an SME pharmaceutical business and therefore enjoyed a unique vantage point over the whole med-tech supply chain – with an informed eye for new product opportunities. Tibbs recalls: ‘We needed to move the business away from general trade moulding and get a new reputation ďŹ rmly established in med-tech and technical moulding. Most people realize that med-tech business generally provides opportunity for better margins. The real beneďŹ t, however, is that once established, med-tech provides a much more stable and sustainable future.’ With the new MD at the helm of operations, and with Lawson pathďŹ nding new clients and new business, the Boddingtons compass was set for a major turnaround. Fast forward to six years later and the stats are impressive. Turnover has been trebled – from ÂŁ5m in 2010 to ÂŁ15m at the beginning of this year. Growth of 7% is forecasted for this year; and the management group is conďŹ dent of meeting a ÂŁ28m turnover target by the end of 2020. Added to which, as previously noted, this is the third successive year it has won the Plastics Design Award.
28 ÂŚ November/December 2015
Moulding Endocuff In winning its 2013 Plastics Industry Design accolade, Boddingtons and Cambridge industrial design company Design Edge worked collaboratively with a team of medical opinion leaders, in order to GHYHORS D UHWURÀ W FRORQRVFRSH VOHHYH WKDW ZLOO LPSURYH WKH HIIHFWLYHQHVV of the 60 million colonoscopies carried out worldwide each year. Endocuff is a disposable sleeve that slips onto the end of conventional colonoscopes to improve mucosal vision and enhance tip control. It was made in collaboration with Arc Medical Design. The Endocuff was developed through Boddingtons in-house, integrated DSSOLFDWLRQ RI 0ROGà RZ 'HVLJQ WR 0DQXIDFWXUH DQG 7RROURRP IDFLOLWLHV to produce prototype tooling, and subsequently pilot production tooling, from which they gained both CE (Technical File) and FDA 510(k) accreditation. 7KH FKDOOHQJH ZDV WR FUHDWH D VLPSOH à H[LEOH UHWURÀ W GHYLFH WR LPSURYH the colonoscopy procedure in terms of visibility, detection, speed (it is currently a 25-30 minute procedure) and patient comfort. The product also had to be able to attach to a number of colonoscope sizes and be mass produced. Materials were fundamental to the success of the project and superstretchy silicone materials, friction levels of rubber and hard/soft PDWHULDO EDODQFH ZHUH H[SORUHG 7KH GHVLJQ IRFXVHG RQ XWLOLVLQJ à H[LEOH hairs to grip the side of the colon wall. Boddingtons investigated the design regarding manufacture issues, took an initial prototype through 0ROGà RZ DQG DFFXUDWHO\ SUHGLFWHG WKH SRVVLEOH ZDOO VHFWLRQV DQG à RZ lengths for success. )URP WKH H[WHQVLYH SURGXFW DQG À HOG UHVHDUFK VXIÀ FLHQW XQGHUVWDQGLQJ was developed for the current product design to include its much shorter length and the collapsible hairs. These QRZ IDOO à XVK ZLWKLQ WKH (QGRFXII VWUXFWXUH PD[LPLVLQJ XVHU FRPIRUW while the device is inserted and during forward movement. When the scope LV H[WUDFWHG WKH KDLUV WKHQ RSHQ RXW enabling the surgeon to view the colon wall behind the folds whilst the scope LV EHLQJ VORZO\ H[WUDFWHG DQG WKHUHIRUH PD[LPLVLQJ LWV HIIHFWLYHQHVV LQ ERWK GLUHFWLRQV
www.med-techinnovation.com
Med-Tech Innovation Plastics
So what are the secrets? ‘Openmindedness is key. No company is too small or too big for us to do business with – and, make no mistake, we work with both ends of the spectrum. A good idea doesn’t care who owns it, and right from the outset we made a point of working with start-ups who speciďŹ cally demonstrated both drive, initiative and strong intellectual property.’ A number of start-up companies which Boddingtons believed in and helped resource are now beginning to produce signiďŹ cant sales. This includes Arc Medical, on behalf of whom they won the Industrial Product Design of the Year in 2013. A stellar-like commercial performance and a continuing upward sales trajectory implies an ambitious programme of investment. In 2014 it became obvious that additional “in-houseâ€? expertise would be required in terms of ďŹ nancial, regulatory and quality support and therefore signiďŹ cant investment was made in people to meet this need. At the same time, Boddingtons successfully implemented a new ERP System (Epicor). This provides total control of all data, from sales leads, ďŹ nancing, purchasing and planning to manufacturing, booking, stock control and dispatch, along with providing full traceability. As new specialists and experts were being brought into the business, so plans were also set in motion to double the size of the company’s production by building an additional facility at the rear of the current factory. Planning permission was gained in in Q1 2015 and building work commenced in Q2. It is expected that the new building will be operational in stages, beginning in Q1 2016.
www.med-techinnovation.com
An approved investment of ÂŁ4.6 million has been earmarked to cover the new ďŹ t-out and additional capacity. Within the new facility, 50% of the space will be cleanroom manufacturing. This will provide two facilities close to each other, which offers ‘Risk Mitigation’ for its customers. The additional building will, other than the cleanroom, be a large whiteroom manufacturing facility, along with a specialised assembly area. The Boddingtons future looks bright. And perhaps it gives the med-tech supply side some hope and encouragement – knowing your own expertise and competence, exploiting your strengths and playing a patient game can be a great recipe for success in medical and healthcare markets.
Hold the line – 2015 winner London based company Braidlock Limited required a manufacturer for its partly-developed intravenous, nasal and central line skin anchor system; a class 1 sterile device, which is manufactured and assembled in a class 8 cleanroom. The goal of the device is to safely and securely hold medical lines in place. The medical device consists of a plaster attached to a braid, which is RI GLIIHUHQW GLDPHWHUV GHSHQGLQJ XSRQ WKH OLQH LW LV WR ÀW 7KH GHYLFH adheres to the skin and the medical line passes through the braid. If the line is pulled, the diameter of the braid automatically reduces and JULSV WKH OLQH PXFK OLNH WKH ROG &KLQHVH FKLOG¡V ÀQJHU JULSSLQJ WR\ The device only takes 30 seconds to apply and costs c. £1.50, whereas competitor products take 4-5 minutes to secure and cost £5 – £7. The key to the success of this product is based upon great design DQG RSWLPXP FRVW ² WZR GULYHUV ZKLFK %RGGLQJWRQV KDG D VLJQLÀFDQW LQà XHQFH RYHU :KHQ %UDLGORFN ÀUVW DUULYHG DW %RGGLQJWRQV LW ZDV DW D SURWRW\SH stage, needing cost to be reduced and design changes made. Firstly, Boddingtons sourced a range of braid sizes from the Farr East to lower cost and a new tool was designed to mould both ends of the braids simultaneously, reducing operational cost. Initially the braid was glued WR WKH SODVWHU YLD D IRRW RQ WKH SUR[LPDO HQG RI WKH EUDLG ZKLFK ZDV DQ H[SHQVLYH RSHUDWLRQ DQG LQYLWHG TXDOLW\ LVVXHV %RGGLQJWRQV UHGHVLJQHG WKH IRRW DQG DGGHG HQHUJ\ GLUHFWRUV WR WKH EDVH LW WKHQ H[FKDQJHG WKH gluing procedure for ultrasonic welding. 7KH %UDLGORFN OLQH DQFKRU LV QRZ SRLVHG IRU VLJQLÀFDQW JOREDO VDOHV EDVHG ÀUVWO\ RQ %UDLGORFN¡V XQLTXH FRQFHSWXDO LGHD LWV WHQDFLW\ WR EULQJ WKH SURGXFW WR PDUNHW DQG DOVR %RGGLQJWRQV¡ LQ GHSWK H[SHUWLVH LQ design for manufacture.
November/December 2015 ÂŚ 29
Med-Tech Innovation Advertorial
Sterilisation Specialist Reveals Investment Plans to Support European Medical Device Industry Listening to industry needs What do you look for in a sterilisation supplier? Reliability? Innovative sterilisation solutions? Continuity of supply? Synergy Health, the awardwinning sterilisation supplier asked this very question, which has resulted in multimillion pound expansion projects across the EMEA region.
Industry training ,Q RUGHU WR HQVXUH VWDII KDYH À UVW FODVV WHFKQRORJLFDO DQG regulatory compliance knowledge, Synergy Health offers a fully comprehensive training programme. Synergy Health’s 2016 training programme will begin with its annual conference. Held on 1st March in Venlo, NL, this event will focus on topics associated with terminal sterilisation and aseptic manufacturing. In addition to inhouse experts, the conference will also feature guest speakers from BSI, European Medical Contract Manufacturing BV (EMCM), Associates of Cape Cod (ACC) and Anecto together with a keynote speaker discussing challenges and pitfalls of device development. This will be Synergy Health’s third annual conference signifying the continued requirement to support the training and development needs of the European medical device industry. Synergy health offers a wide range of training and educational opportunities from free to attend interactive webinars, to tailored workshops (for up to 10 people) and EHVSRNH FXVWRPHU WUDLQLQJ DOORZLQJ FRPSDQLHV WR VSHFLÀ FDOO\ focusing on their organisations sterilisation requirements.
Supply chain innovation With over 30 years’ experience, Synergy Health understands the LPSRUWDQFH RI OLVWHQLQJ WR LWV FXVWRPHUV 6SHFLÀ F DWWHQWLRQ KDV been given to supply chain innovation which has resulted in an investment of over £18m in expansions to support customers requirements. Customers of the technology neutral supplier ZLOO EHQHÀ W IURP LQFUHDVHG JOREDO FDSDFLW\ LQ UDGLDWLRQ *DPPD Electron Beam and Xray), Ethylene Oxide and laboratories. The European phase of the expansion project will SURYLGH LQFUHDVHG *DPPD FDSDFLW\ LQ (GH WKH 1HWKHUODQGV DQG %UDGIRUG 8. 5DGHEHUJ *HUPDQ\ ZLOO EHQHÀ W IURP H[SDQVLRQV LQ ERWK *DPPD DQG (OHFWURQ EHDP LQ DGGLWLRQ WR DQ enlargement of the warehouse. EO expansions have taken place in Velka Bites (Czech Republic) with a fourth line and secondary degassing chamber.
EO expansions are also present in Michalovce (Slovakia) in the form of an additional line and preconditioning chamber. A new laboratory is under construction in Radeberg in addition to the expansion of the laboratory in Seriate (Italy), both of which will strengthen the regional network supporting the medical device and pharmaceutical testing requirements. With a deeply rooted commitment to the environment and the surrounding communities, Synergy Health has an unwavering reputation for exceeding all industry and regulatory standards.
Research and development As the European medical device industry continues to lead with innovate products, Synergy Health has made further investments in research and development to support industry LQQRYDWLRQ $ QHZ 5 ' *DPPD WHVWLQJ LUUDGLDWRU KDV EHHQ installed in Marcoule (France) using a design uniquely capable RI SURYLGLQJ VSHFLĂ€ F WDUJHWHG GRVHV
A global integrated network laboratories As a full service supplier, all Synergy Health sterilisation VHUYLFHV DUH IXOO\ VXSSRUWHG E\ D À UVWFODVV QHWZRUN RI ODERUDWRULHV 7KH QHZ ODERUDWRU\ LQ 5DGHEHUJ *HUPDQ\ LV being created to s upport the strong growth in customers from *HUPDQ\ 6ZLW]HUODQG $XVWULD DQG 3RODQG XVLQJ WKLV IDFLOLW\ DQG VLVWHU VLWHV LQ $OOHUVKDXVHQ *HUPDQ\ DQG 'DQLNHQ 6ZLW]HUODQG The laboratory will be state of the art with ability to test according to ISO 11137 with bioburden, environmental and LAL WHVWLQJ IDFLOLWLHV DQG D *03 FRPSOLDQW FODVV FOHDQURRP Mark Botting, EMEA Laboratory Business Director said "We are pleased that the Synergy Health Board has agreed to further investment in the EMEA Laboratory network and this will support the strong network we already have in the UK, Netherlands, Ireland and Italy which has supported the regulatory requirements of our customer base for over 20 years".
)RU IXUWKHU GHWDLOV RQ KRZ WKH IHDWXUHG GHYHORSPHQWV FDQ EHQHĂ€ W \RXU FRPSDQ\ SOHDVH FRQWDFW Email: assistance@synergyhealtplc.com Tel: +44 (0)8456 88 99 70
30 ÂŚ November/December 2015
Or to book your place at the conference, please visit: www.synergyhealthplc.com/events www.med-techinnovation.com
Synergy Health’s 3rd Annual Conference:
Concept to market... and everything in between. Guiding you through the challenges and identifying solutions to deliver your product to market.
1st March 2016 | Venlo, The Netherlands | €200 (€150 early bird rate)
Conference topics:
To book your place:
o Choosing the correct technology o Maintaining compliance o Working through the challenges:
Web: www.synergyhealthplc.com/events
- Packaging integrity - Pyrogen testing (LAL) - Microbiology - Chemical analysis
Email: education@synergyhealthplc.com Phone: +44 (0) 8456 88 99 70
Med-Tech Innovation Medical Physics
The connected hospital Gravity-defying heroics from the Medical Physics team at St George’s, SW London, have now put the renowned teaching hospital on the leading edge of patient monitoring and connectivity. MTI magazine takes a first look at the system.
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avid Tropman, Clinical Bioengineer, and Jonathan Silver, Clinical Engineer, scoped and led the work-intensive project that now serves the entire hospital in SW London with patient monitoring and connectivity. The patient monitoring is standardised and interconnected for all corners of the building, including cardiac theatre treatment and the intensive care departments. At the outset a large number of electronics suppliers were invited to submit proposals. A shortlist of three was selected and Philips Healthcare emerged as the successful candidate. There are five intensive care units (ICUs) and twelve other clinical areas at St George’s, which are using the system as well as a separate deployment of the same technology for operating theatres and interventional radiology. The ICUs are neonatal, paediatric, general, cardiothoracic and neuro. The latter three are all adult units that are geographically and workforce-distinct, 32 ¦ November/December 2015
but share some clinicians and form a single clinical directorate. The monitoring system provides continuous physiological monitoring, appropriate for each individual patient’s needs. The data is displayed in real time and recorded in high temporal fidelity on a central server. The data can be reviewed at the bedside or remotely, via a web portal, while some of the monitoring hardware is portable and can travel with the patient around the hospital. The single system now deployed through St Georges has obvious advantages in terms of familiarity, compatibility, training and ease of central monitoring. The medical physics team led by Tropman and Silver, for example, is able to remotely overview any of the 400plus workstations from a central location and in real time, while being able to assess current performance and also monitor that the technology is being used in an optimum manner. www.med-techinnovation.com
Med-Tech Innovation Medical Physics
Thinking of doing it? The St George’s medical physics team have kindly provided a short checklist for other hospitals going connective… Have a ‘go to’ person for the project – this person not only liaises across all the departments but is the central contact for questions as the project progresses; accordingly they’ll need background knowledge and an understanding of the equipment and how it works which is why the medical physics department were able to manage the project so well at St George’s. Also have a ‘go to’ team – It is beneficial to have a clinical training lead and a technical lead, so there are single points of contact that understand the whole project deployment.
This medical physics control also enables the team to stratify and prioritize the whole internal infrastructure of the hospital’s internal communications; one simple example being the team’s decision to prioritise the patient monitoring over and above the phone lines within the hospital’s IT infrastructure. St George’s is now clearly benefitting from the boldness of its singular approach and the economies of scale with the technology are self evident to any visitor. Needless to say, the project management and implementation of such a project needs to be more than first class. Philips believes that this is the first such implementation of this technology at this level of scale in Europe. MTI magazine will hope to report on the usage and continuing evolution of the system in the months to come.
Be prepared to have lots of meetings – an installation of this nature requires very wide consultation from day one; so plan for numerous meetings – scoping needs, the install deployment and the staff training Expect the unexpected – when you carry out something at a new level, there will always be a degree of learning as you go, so prepare as much as possible across clinical needs, estate, IT and procurement requirements. Be prepared for anything! Keep the core decision making team as focussed as possible – the bigger the decision making team, the longer the process takes. Find the balance. Start in the right place – if there is a smaller nonurgent area, start the install there so that when you install in critical care areas and larger spaces, you come to it with experience and insights Co-ordinate patient-centred installs – install in cohesive way that doesn’t disrupt patient care; for example do a department’s theatres, wards and recovery bays in order of the patient flow, rather than all theatres, then wards – this ensures care continuity for the patient. Plan holistically and standardise wherever possible – standardise each element of the equipment so that it’s truly ubiquitous across the hospital site. This provides maximum flexibility for the future and reduces the cost of other supporting products such as cables, batteries, mounting equipment. Prioritise the monitoring – at St George’s we prioritised the patient monitoring over the phone lines within the IT infrastructure. It may seem an odd decision at first, but if patient monitoring goes down in critical areas, it’s a big problem.
www.med-techinnovation.com
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The magazine for the UK and Irish medical device design and manufacturing industry Sign up to receive your FREE subscription here:
www.med-techinnovation.com Med-Tech Innovation is a communications hub dedicated to talking to, and talking about, the UK and Irish medical device design and manufacturing community. We are a unique information resource that brings together the diverse networks that are active in this vibrant industry. Med-Tech Innovation offers you a range of technical articles from experts around the world, as well as information on industry developments, research and development activity from universities, technology transfer opportunities, and news of innovation from the suppliers to the industry. And it is all completely free.
Sign up now so that you do not miss a single FREE issue of Med-Tech Innovation, go to www.med-techinnovation.com or e-mail: circulation@med-techinnovation.com Choose your preferred format for Med-Tech Innovation: s¬ !¬DIGITAL¬EDITION¬DELIVERED¬TO¬YOUR¬EMAIL¬ADDRESS s¬ !¬PRINTED¬COPY¬DELIVERED¬TO¬YOUR¬ADDRESS¬IN¬THE¬5+¬OR¬)RELAND EVERY ISSUE IS PACKED WITH USEFUL TECHNICAL INFORMATION AND INDUSTRY NEWS AND IT IS COMPLETELY FREE
Med-Tech Innovation Injection Moulding
Wittmann Battenfeld – ready-made moulding for med-tech solutions Injection moulding machinery supplier Wittmann Battenfeld has launched the first in a series of bespoke plastics processing solutions for today’s busy med-tech moulder.
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ittmann Battenfeld UK Managing Director Barry Hill hails the move – showcased at the Fakuma plastics exhibition, Germany in October 2015 – as ‘great news for injection moulders and for the med-tech sector generally.’ He adds that ‘Med-tech moulders often face a burden of testing and compliance issues regarding standards, clean room conditions and so forth. Our new range is designed and manufactured to help the moulder by having all of that ready to go from ‘out of the box’. We are optimistic that the new machines will make an immediate impact – globally and here in the UK.’ Over the last few years, Wittmann Battenfeld has shown that the company’s technologies are ideal for clean room applications, especially regarding the allelectric machines from the EcoPower and MicroPower series. Based on this experience, the company decided to extend its activities in the area of medical technology and to develop and specify its machines much further in order to meet the current requirements of customers from the medical technology industry. As a first step it was decided to qualify a version of the all-electric EcoPower to clean room conditions. For this purpose, an ISO standard class 6 clean room from Max Petek Reinraumtechnik, Germany was installed at the Wittmann Battenfeld plant in Kottingbrunn, and the machine was thoroughly examined there. At the same time, GMP (good manufacturing practice) standard machine documentation was been made available for machines of the Medical version. In this way, Wittmann Battenfeld has established the necessary prerequisites to meet the market demand in respect of machine capability documentation and software. The clean room measurements are carried out under both dry running and production conditions, to obtain as clear and accurate results as possible concerning the equipment’s emissions. The pre-installation of the clean room now gives the company’s customers an opportunity to carry out production tests for tooling acceptance at the Kottingbrunn facility under real conditions.
www.med-techinnovation.com
Barry Hill, Managing Director of Wittmann Battenfeld UK
In further developing the allelectric EcoPower for clean room applications, special attention was paid to optimizing the interior mold space, which comes equipped with smooth surfaces, stainless steel covers and covered guide rails. The exhaust air conduits of the pneumatic valves are bundled and thus guided out of the clean room. The machine as a whole has also been provided with a water cooling system with a closed cooling circuit, special alcohol- and solvent-resistant paint, nickel-coated clamping plates with covered threaded drillings and a laminar flow box, which supplies air with low particle content to the interior mold space. All openings in the mould area and the threading of the clamping plates are covered. The barrel insulation also minimizes emissions into the environment. For lubrication, exclusively “food grade” lubricants are used. At the Fakuma show , the functionality of the EcoPower’s clean room model will be demonstrated by the production of a contact lens tray made of PP on an EcoPower 110/350. In addition to the features already mentioned, the machine on display at the exhibition was equipped with a good part / reject separator and an encapsulated clean room conveyor belt from Max Petek Reinraumtechnik, Germany, mounted below the clamping unit. The parts fell freely onto the encapsulated clean room conveyor belt and were subsequently transported to a laminar flow workstation.
November/December 2015 ¦ 35
Med-Tech Innovation Prosthetics
‘No limits’ from RP Technologies When Steeper recently required intricate prototype and production components for a miniaturised version of their bebionic prosthetic hand, they turned to RP Technologies for the company’s wide ranging expertise and flexible engineering solutions.
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rosthetic experts Steeper wanted to produce a myoelectric prosthetic hand that could transform the lives of amputees worldwide and help them to regain independence and control in their everyday lives. Steeper developed the bebionic, which is modeled on an accurate skeletal structure and is constructed from an array of components designed to provide the most trueto-life movements. This artificial hand Nicky Ashwell, the first UK user of the bebionic small hand marks a turning point in the world of prosthetics, successfully mimicking the functions of a real hand via 14 different precision grips – enabling amputees to engage in a range of activities that would have previously been complex and unmanageable. Following the success of the bebionic, Steeper began to develop a miniaturised version – the bebionic small – and approached RP Technologies with the challenge. Steeper needed a supplier that could turn around complex parts without compromising the quality. They also wanted to find a company who could manufacture aluminium tooling and injection moulded components under one roof. RP Technologies provided a successful fit, the company policy being to provide a dedicated engineer to The bebionic small hand look after each client project, from CAD model through to finished componentry, including the benefits of an
in-house tool room and mould shop, all housed within facilities on the Pensnett Trading Estate in the West Midlands. The brief to RP Technologies for the latest Steeper project was to develop and manufacture prototype and production components for the bebionic small. Ultimately, the challenge was to help solve the technical issues that occurred with the miniaturising of the components, and to ensure the design was suitable for plastic injection moulding. With the miniaturisation of the original components Steeper had to review the wall thickness on all nine parts in order to ensure the components were suitable for injection moulding. One of the main concerns with thin wall sections was flow length over the larger components. The component mostly affected was the palm: Steeper specified that a TPE (thermoplastic elastomer) resin should be over-moulded on an ABS substrate. A problem had previously arisen in that the TPE material was too thin – not carrying adequate heat to form the chemical bond between the ABS and the over moulding. After considerable development the engineers at RP offered a solution that met Steeper’s specifications without compromising the component design. RP manufactured and supplied Steeper with a number of components for the latter’s testing and development process. The required modifications were made to the aluminium tooling and new samples were also manufactured for approval. Once Steeper had approved the prototype components the design was frozen. An order was then placed for over 500 production parts across all 9 components. Paul Roe, General Manager at RP Technologies said that ‘it has been a real privilege to work with Ted and the team at Steeper, and to provide components for such a life-changing product. We’ve really enjoyed the technical challenges and our ‘without limits’ philosophy has meant we’ve been able to supply complex components that fit the customer specification.’ For further details www.bebionic.com www.rptechnologies.co.uk
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www.med-techinnovation.com
Med-Tech Innovation Advertorial
Ask eg
:HDUDEOH 0HGLFDO 7HFKQRORJ\ ² IURP D ÀWQHVV DFFHVVRU\ WR D OLIH FKDQJLQJ PHGLFDO GHYLFH What are the challenges facing companies developing wearable technologies? A wearable medical device is a piece of equipment that is attached to the body that detects and monitors changes in specific physiological or biochemical measurables. We are seeing rapid growth in the wearables marketplace, spurring application development across the breadth of industry and most noticeably in the medical technology market. Whilst the fitness accessory market is more established and adoption is high, there are many more complex considerations to take into account for the medical market. How do you categorise a wearable medical device? Wearable medical devices can be divided into two categories; Diagnostic and Therapeutic. Diagnostic devices include vital signs monitors, foetal and obstetric devices and neuro-monitoring. Therapeutic devices include those developed for pain management, insulin therapy, respiratory therapy, sports and fitness applications, remote patient monitoring and home healthcare. Devices can be invasive (penetrating the skin/body) or non-invasive (attached to the skin using sensors or sufficiently local to the biometric to enable measurement). All these devices are designed to monitor and collect real-time health information by monitoring changes in biometrics. What electronics and software will you need for wearable technologies and what are the challenges? A common aim of designing wearable devices is to make the device as small as possible. This tends to lead to highly integrated ‘system-on-chip’ solutions and it can be challenging to develop such systems for products with modest sales volumes rather than the high sales volumes of the mobile phone market. The hardware and software needs to operate at a consistently high standard; this is a critical issue if the user’s health is dependent on the device. Although healthcare ‘apps’ are now beginning to emerge for the standard mobile platforms (iOS, Android, Windows) there is little standardisation for application programming interfaces. For higher risk devices that monitor and control vital physiological functions, validated real-time operating systems are available but may come with a much higher development and deployment cost. You also need to consider the sensitivity of the data that these devices will be creating, developers must tackle crucial issues such as security and privacy. Does your solution need to be wireless? Wireless enables freedom for the user in a number of ways. Firstly it enables reporting of results to a smartphone or base station, and that in turn enables
remote data gathering and/or decision making. Secondly, powering or charging wearable technology is key to making it seamlessly integrate with lifestyle. Emerging wireless technology could allow contactless charging for wearable devices as opposed to the inconvenience of removing the device and charging in a stationary power source. Energy harvesting through movement or thermal energy would also remove this inconvenience.
What materials should you consider? The interface between the wearable and the skin is an important challenge to overcome during product development. Considering aspects such as common skin allergens and irritants when selecting materials, and therefore selecting only materials of high quality or medical grade, is key. Early consideration of practical usability factors such as ergonomics, skin contact hygiene and attachment / reattachment practise will give the best outcome. Consider which elements should be disposable versus cleanable and the IP rating required for those devices operating in wet conditions. Ensuring that these things are taken into consideration early in development will reduce risk within the programme and maximise the chances of successful adoption in the market place. What are the regulatory challenges? There are well established guidelines for bringing medical devices to market (the MDD), therefore medical wearable technology with clear medical claims must be approved by the appropriate regulatory authority in the same way. Additionally wearable technologies must be compliant with the applicable software development standards as well as data protection directives. The wearable medical technology market has the potential to be both lucrative and competitive. Many of the devices available today provide information that has a positive impact in the wellbeing, health and fitness market. The race is on to find the most effective (and ideally non-invasive) form of gathering meaningful patient clinical data from multiple biometrics for real-time clinical diagnosis.
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
November/December 2015 ¦ 37
Med-Tech Innovation Opthalmic Surgery
Sterimedix lands its punches with Sodick Sterimedix, one of the world’s leading manufacturers of single use medical devices for ophthalmic surgery and non-surgical procedures, has acquired a Sodick AG40L from Sodi-Tech EDM.
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his advanced die sink machine has enabled the company to improve the quality of its products, and generate significant cost reductions compared with the outsourced operation used previously. These savings put Sterimedix on course to achieve a payback on investment within eighteen months. At its Redditch UK facility, Sterimedix manufactures a comprehensive range of cannulas, hand-pieces and devices for all types of ophthalmic surgery and aesthetic procedures. The business has been built up over twentyfive years, and now employs in excess of fifty people who together generate an annual turnover of around £6 million. Approximately 80% of output is exported throughout the world. ‘We started manufacturing cannulas 21 years ago, gradually increasing our manufacturing capability ever since,’ explains Tom Parrott the company’s head of technical operations. ‘Five years ago we relocated our operation to larger premises, and six months ago made the decision to rent additional premises nearby with the objective of creating an up to date manufacturing facility, with EDM machining at its core. We believed that by bringing EDM in-house, we would be able to take control of an important area of our production, introduce product improvements and generate cost reductions.’ A comprehensive review of the EDM operation was undertaken by Sterimedix, where activities include the processing of stainless steel micro-bore tubing – typically with outside diameters ranging from 0.4 to 0.9 mm. These processes involve various operations such as welding, tube manipulation, swaging, porting and polishing. Porting
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is an operation that creates either single or multiple holes in the side- walls of tubes. ‘Previously our subcontractors ported tubes singly,’ explains Tom. ‘In order to secure a return on the EDM investment, it was necessary to improve throughput significantly. This was achieved by working closely with the engineering team at Sodi-Tech.’ Tom recalls that the Sodi-Tech team indicated the possibility of porting 40 tubes at a time. That indication is now a reality. The selection of the Sodick AG40L EDM machine followed a number of visits to potential suppliers, with each one evaluated against a decision matrix. Largely as a result of its extensive support structure and the assistance given by the company’s applications engineers, Sodi-Tech was identified as the preferred supplier. ‘Sodi-Tech were proactive in arranging trial batches of components to prove the accuracy of the machine’s capabilities, and in supplying names and addresses of existing users so that we could discuss their experiences with the machine,” says Mr Parrott. ‘This ability to verify the performance of the machine pre-purchase, and an attractive offer within our budget, culminated in us taking delivery in December 2014.’ Although the acquisition was a significant capital investment for a company the size of Sterimedix, it offered the opportunity to improve quality and achieve cost reductions. ‘In the time since installation, Sodi-Tech has continued its support throughout the various validations that we needed to undertake, and we are on target to achieve payback within 18 months,’ says Tom. www.med-techinnovation.com
Med-Tech Innovation Wearable Technology
New methods for spinal surgery Researchers have designed a way to improve the safety and efficiency of a complex surgical procedure for children with cerebral palsy, by using wearable technology similar to Google Glass.
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he design, by Nottingham Trent University in collaboration with Nottingham University Hospital NHS Trust, allows clinicians to be given crucial surgical information live in theatre, via an optical head-mounted display unit during the operation on a child’s spine. The procedure – a selective dorsal rhizotomy - involves the severing of two-thirds of a nerve root in order to improve the muscle stiffness children with cerebral palsy experience in their limbs. Currently a surgeon has to perform this operation based on information relayed to him verbally by a colleague on a screen elsewhere in the operating theatre. But the new design will project the information – which presents how responsive the nerves are – onto the lens of the optical head-mounted display, so he can monitor it while performing the surgery. The research has been led by Professor Philip Breedon, a professor of smart technologies in Nottingham Trent University’s Design for Health and Wellbeing Research Group, in consultation with Professor Michael Vloeberghs, a professor of paediatric neurosurgery and Honorary Consultant Paediatric Neurosurgeon at the Nottingham University Hospital. It was developed by postgraduate student Mark Golab as part of his MSc in Medical Product Design at Nottingham Trent University. ‘This design allows a surgeon to analyse crucial data in his line of sight, hands free, in real time, without the need to look away from the working field of view – and to also communicate across the operating theatre while he’s performing this procedure,’ says Golab. ‘In this way, the efficiency of this surgical procedure can be improved whilst also allowing the surgeon to have a better understanding of the live information needed in order to perform the operation.’ A tiny exterior-facing camera on an optical headmounted display unit will also enable the surgeon’s perspective of the operation to be broadcast live to a third party. The design recently went on public exhibition at the School of Architecture, Design and the Built Environment’s Postgraduate Design Exhibition 2015 in Nottingham city centre. Professor Breedon says: ‘This a fantastic example www.med-techinnovation.com
Professor Philip Breedon (left) with Mark Golab
of how advances in technology can be applied to help improve critical medical procedures. By utilising this emergent optical head-mounted display technology, we’re able to improve how information is relayed to surgeons during a critical operation which is required to improve children’s lives. It’s consequently very important that designers keep working with healthcare professionals so as to consider how advances in technology can help improve surgical procedures and can allow surgeons a greater capacity to perform their duties.’ Professor Vloeberghs, who performs selective dorsal rhizotomy operations, said: ‘This is an example of ‘live update’ direct from a monitoring device to the surgeon. The monitoring information is displayed directly and allows the surgeon to keep sight of the area where the procedure is being done – rather than looking away to a monitor or having the information relayed second-hand by a technician doing the monitoring. This example therefore proves the feasibility – and is a clear example – of the possibilities in this technology for use in teaching, training and supervision, as well as in providing a ‘live’ second opinion in uncommon procedures.’ November/December 2015 ¦ 39
Med-Tech Innovation Recruitment
ManPower for Med-Tech In the previous issue of Med-Tech Innovation magazine Samantha Blythe Moore of Medical Engineers had plenty of sound advice for companies seeking to attract the best talent. Here she offers some timely pointers to those candidates setting out on their careers.
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re-Xmas is such a busy time for most people, but for final year undergrads, it’s around this time when they really begin to think about potential employers. The ‘first appointment’ after graduation can really define a career path: The breadth of opportunity currently available and the type of graduate programme, will certainly give those graduates a flavour of what the Med-Tech market can offer in terms of a challenging and exciting career. So where to begin? Well, let’s work back from the answer. What is it that you want? If you’ve already decided what area you want to specialise in, then is there really any point in completing a two-year graduate scheme, where you spend 3-4 months in various departments? On the flip side, if you’ve no idea yet what your specialism will be….you just love medical devices!...then this could be the perfect solution for you. Another option is to go for a graduate specialist role, for example a graduate design engineer role in a smaller company. Here you will get to specialise but you will work closely with all the other departments in the business and get a really good understanding of the product development lifecycle and all the influencing factors which affect the design of the product. Research, Research! If you really want to secure a role with your employer of choice you need to invest some time now. All companies will have a website, now you can register your interest via these websites. Why not follow the crowd? And also remember to engage with your target employers through Social Media. It has never been more prevalent as a job search tool, providing immediate access to talent acquisition teams and recruiting managers directly… what’s not to love? Remember that anybody can rattle off a few statistics about profits, number of employees or key products. In addition, therefore, try to really understand the target organisation and, above all, how you can add value to it. Show insight and commitment. Look at the latest news, trade press and competitors to comprehend the 40 ¦ November/December 2015
key challenges and opportunities they face. Work out how your experience and expertise will help tackle these challenges. Network, Network! Companies recognise that to secure the best of future talent they need to be engaging with future talent across all social media channels, so get ‘talking’ or stalking your target companies, follow twitter feeds, join facebook groups. Check out company alumni’s, especially those on LinkedIn. Connect and message with these people where appropriate and start getting the inside track. In summary, it has never been easier to get in front of decision makers – all from the comfort of your phone, laptop or tablet! You can use your own network to find information about the interviewer and possibly the team you may be working in. Use LinkedIn and other networking sites to gather all the intelligence you can. It’s never too early to start engaging skilfully and get yourself known…in a good way. Always remember that competition is fierce. A recent graduate recruitment campaign of ours for a blue chip international medical device company yielded over 400 applicants for 2 available roles. You need to stand out! Remember also that the Medical Device and Diagnostic (MD&D) industry within the UK is at the forefront of some of the most innovative and technological advancements in the world. And so when the time is right, you make seek the value of a third party chat and assessment. At Medical Engineers we specialize in working with the widest range of med-tech companies from small start-up, medium sized and large global businesses. And we are here to help candidates at all levels and ages – whether broadening or deepening your career in medical device development, be that within biotech, pharmaceutical, diagnostics (IVD), medical electronics, orthopedics, surgical instruments, wound care, drug delivery, research and development or consultancy. In the coming weeks and months we shall be working with MTI Magazine and with the EXPO 2016 event in order to further highlight and catalyze these issues; bringing talent and companies together. www.med-techinnovation.com
Med-Tech Innovation Money for Med-Tech
Steadily rising to the precision challenge Dr Gugs Lushai of LifeSciences Healthcare continues his column on matters of growth and finance for the med-tech industries.
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e enjoyed an excellent day at our Novel Markers for Better Patient Healthcare event at the Rutherford Appleton Laboratory on October 12th, and were part witness and part mid-wife to a new medical paradigm that is steadily coming of age. It goes by the name of Precision Medicine (PM) – a hot topic in healthcare today, especially in life sciences. For PM to accelerate here in the UK, a diverse group of stakeholders—including clinicians, academic researchers, industry, regulators, NICE, patients, commissioners and providers, along with emerging specialisations—need to work together in a much more dynamic way in order to be at the cutting edge of new developments in precision medicine. That was the aim of our October 12th event, and I certainly felt that we served a good purpose in mapping out various parts of the common theatre of operations. According to Dr. Ger Brophy, Chief Technology Officer of GE Healthcare’s Life Sciences business the meaning of PM is not so difficult to interpret “Precision medicine,” he said “means, in any setting, rich or poor, providing the best care for each patient by using insight from all the available actionable data. This is not treating each person with a ‘personalized’ therapy, but means systematically combining data to help make clinical decisions that improve patient outcomes.’ In other words, PM promises a radical approach to healthcare, founded on emerging new abilities to class diseases as they impact on a variable patient population. This ability is anchored by the capacity to handle increasingly large data sets, which are targeted on understanding clinical pathways in much more detail. The precise use of data affords new opportunities for more precise diagnostics and targeted therapies that can deliver better treatment outcomes. The increasing ability to predict and measure outcomes in different patient populations is set to usher in a new era of patient care. These goals do not come without their own challenges. They are often costly to diagnose and to treat. www.med-techinnovation.com
Thus, while PM is a desirable approach, it is by no means an easy pathway. In addition, and from my perspective, developing new precision medicine products will require new business models and new definitions of value. The PM cause will be greatly helped here by a national leadership role for the new innovation centre, the Precision Medicine Catapult, which opened in April this year. The overall PM scope is broad and deep, and is already having a major impact in various areas (such as diagnostic imaging). At its core, it will lead to disruptive changes in healthcare systems. The patient will play a central role in this transformation, and the way in which patient information is used to inform new approaches to research and healthcare delivery will, in turn, impact on the rate and depth of the opportunities afforded by precision medicine. The ambition of the new Precision Medicine Catapult is to make the UK the most compelling location in the world for the development and delivery of the PM approach. This is a worthy and reasonable aim. The UK already has a competitive position in this field, based on scientific excellence and the £1bn of research infrastructure invested by Government over recent years. LifeSciences Healthcare and myself are looking forward to the next phase of operation. November/December 2015 ¦ 41
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