MPN EU Issue 5 by MPN Magazine

MPN

MEDICAL PLASTICS NEWS

Smarter Devices deserve Smarter Compounds

ALSO IN THIS ISSUE: SILICONES COLOUR IN DEVICE DESIGN COUNTRY FOCUS: SWISS FINISHING MD&M WEST MEDTEC EUROPE

come and meet Innovative Polymer Compounds Ltd at MEDTEC Europe stand 4269

ISSUE 4 February 2012 WWW.MPNMAGAZINE.COM

MPN

All Medical, All Plastics

Contents

Page 10

5. Editor’s letter: Sam Anson Our first issue of 2012 is a cracker with guest editorial from Lauren Myatt and Gareth Pickering. 6. On the Pulse: Engel’s new integrated Stäubli automation The new technology, showcased at Engel UK, automates cannula production in the mould.

Page 24-25

Page 46

10. Cover Story: The Cleverest Compounders in Town Ireland’s Innovative Polymer Compounds Ltd tell us about their links with the CRANN institute and their intelligent medical grade polymer compounding. 14. Medtec Preview: Germany’s leading device show Gregor Bischopf, event manager, gives us the lowdown and we profile the most relevant exhibitors in plastics. 24. Design 4 Life: Colour in medical devices Lauren Myatt reports on the evolving trend for integrating demanding pigments into plastic devices.

Page 54

28. MD&M Preview: Across the pond We preview the SPE Medical Plastic Division’s conference and the main plastic suppliers at the USA’s 2,700exhibitor strong device show.

38. Doctor’s Note: UK Clinicians Gathering in March Mehdi Tavakoli, representing the UK’s Healthcare KTN, tells us about his upcoming networking event on March 6. 40. Country Focus: Swiss Finishing Gareth Pickering reports from his tour of the most passionate “precisionists” in Europe. 49. Material Diagnosis: Silicones PIP implants, silicone production and compounding. 54. End of Line: Lasers and Ultrasonics A fair hearing for laser welding in hearing aid, ultrasonic cutting of urinary catheters and a new welder from Miyachi. 58. Regulation Review: Your quick reference guide to device classification Lauren Myatt gives a quick reference after attending a course on device regulation given by iSmithers. 62. Folio: High Res images Images from Interface and PolyOne. 64. Events: Shows and conferences Brand new trade show Mediplas 2012 and more.

Online and in digital Page 62-63 Cover catheter image courtesy of Interface

Medical Plastics News is available online, at www.mpnmagazine.com, and in digital (on the iPad, mobile phones and computers) via MPN Xtra. FEBRUARY 2012/ MPN /3

MPN | EDITOR’S LETTER

ur first issue of 2012 is a cracker. Since Compamed in November we’ve been out on the road finding out about what is making us medical plastic bods tick right now. And we’re pretty proud of what we’ve discovered. Perhaps the most prominent piece of news that we’ve picked up on is the PIP silicones “Our first debate. Somehow, implants issue of 2012 silicone were certified, sold is a cracker” and implanted despite being made from non-medical grade silicone. But apparently, patients should not worry too much — one panel of expert contributors, intelligently collected by our contributor Lauren Myatt, reckon that although shocking news for the industry, the silicone used is still highly likely to be safe. Turn to page 49 for the full article. The second highlight in this issue has to be our Switzerland focus, researched and written by our very own correspondent cum advertising manager Gareth Pickering. He was lucky enough to visit the country before Christmas (there are worse times to be visiting the foothills of the Swiss Alps) and take a tour of some of the country’s leading suppliers to the device industry there. You won’t be surprised to read that he was greeted by perfect precision, ingenuity, commitment and passion — the ethos of Swiss medical plastics manufacturing. On our travels we get to speak to so many suppliers and buyers, we are spoilt for choice when selecting the most important content for our readers. However, one extremely common and pertinent trend is the increasing use of colour in medical device design. Integrating colour is challenging because some colour pigments are renowned to be instable in certain compounds. That said, high demand for medical grade

colour compounds from OEMs is driving technological development in this area at a rapid pace. And perhaps the location which is leading the way in this respect is the UK — which is becoming known as the design capital of the world (at the time of going to print it was only yesterday that plans were unveiled to invest £80 mn in a new design museum in London to open in 2014). Our design for life section focuses on colour in medical devices and profiles a UK company who is absolutely leading the field in this respect — Team Consulting in Cambridge. Turn to page 24 for the full (colour) story. The UK will also be enriched with a new medical trade show in September 2012, Mediplas, launched by the same team who revived Interplas. And we also have news of a gathering of clinicians to help the UK device industry get directly in touch with its end users. Talking of compounding, we have found some of the leading experts in compounding polymer for nanotech devices. With a tag line of “Smart Devices deserve Smart Compounding” Innovative Polymer Compounds (IPC) are on something of a surge since they were set up in 2008. Turn to page 10 for more. Elsewhere in the magazine, we have the first in a series on device classification on page 58, written by Lauren Myatt after attending a course on medical device regulation by iSmithers, a round up of end of line laser and ultrasonic equipment on page 54, a preview of the first of the big device shows in the States, MD&M West, on page 28, and a preview of Medtec Stuttgart, to be held on March 13-15, 2012. At MD&M West, there will be a two-day conference held by our partner the SPE Medical Polymer Division. The conference will showcase some brilliant speakers from Dow, Abbot, Teleflex Medical OEM, BASF, Evonik, NuSil, Eastman, Kimberley Clark and many more.

MPN | CREDITS

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Medical Plastics News is published by: Plastics Multimedia Communications Ltd, Unit 2, Chowley Court, Chowley Oak Lane, Tattenhall, CH3 9GA T: +44(0)1829 770037 F: +44(0)1829 770047 © 2011 Plastics Multimedia Communications Ltd While every attempt has been made to ensure that the information contained within this publication is accurate the publisher accepts no liability for information published in error, or for views expressed. All rights for Medical Plastics News are reserved. Reproduction in whole or in part without prior written permission from the publisher is strictly prohibited. BPA Worldwide Membership ISSN No: 2047 - 4741 (Print) 2047 - 475X (Digital)

FEBRUARY 2012/ MPN /5

ON THE PULSE | News from the industry

Engel set to revolutionise

the injection moulding process of syringes

ENGEL HAS PRESENTED A HIGHLY INTEGRATED PRODUCTION CELL THAT COULD REVOLUTIONISE THE MANUFACTURING OF CANNULAS AFTER RECOGNISING THE INCREASING DEMAND FOR INNOVATIVE MEDICAL MOULDING TECHNOLOGY. THE PRODUCTION PROCESS RELIES ON AN ALL-ELECTRIC ENGEL E-MOTION 200/100 T INJECTION MOULDING MACHINE, WHICH IS EQUIPPED WITH AN INTEGRATED STÄUBLI TYPE TX 90 SIX-AXIS ROBOT. Disposable hollow cannulas for insulin pens are produced in a highly automated process. The singlestep manufacturing process is an innovation compared with legacy multiple step methods, which first manufacture the needle holder in an injection moulding step and then glue in the hollow needles. To save a complete step, as well as adhesive, the Engel solution uses a multiple-axis robot to remove the needles from the magazine and insert them into the 3-cavity pilot mould by Zahoransky, a global leading supplier of injection moulds and automated solutions, where they are overmoulded with polypropylene, before being taken off again by the

NOVEMBER 16, 2011 Teknor Apex gives European PVC distribtution deal to IMCD

6/ MPN /FEBRUARY 2012

Johan Scholten, IMCD’s director business group plastics, commented, “We have enjoyed a very fruitful partnership with Teknor Apex for a number of markets over the years. Teknor Apex is an innovative technical leader with a strong sense of responsibility to produce products that are safe for customers and consumers, and that comply with requirements established in their prospective market areas.

November 22, 2011 Gerresheimer wins the German Packaging Award for its new multilayer plastic vials

multiple-axis robot. Under the name easix ENGEL has fully integrated the multi-axis robot into the CC 200 control unit of the injection moulding machine without the Euromap 67 interface. So the multi-axis industrial robot can be operated with the customary simple instructions of the machine control unit. The all-electric Engel e-motion injection moulding machine series is predestined for applications in cleanrooms with encapsulated drives, sealed toggle, smooth surfaces and an encapsulated barrel. The production cell was showcased recently at Med.con, a special open day where Engel opened its Warwickshire-based doors to almost 80 members of the medical moulding community for them to see a selection of the latest innovations. During the event, which took place in November, partners of Engel, which included Ewikon and Cantoni, presented thought provoking insights into the future of the medical moulding industry.

According to the press release: “The multilayer composite of COP and polyamide even prevents leakage of the solution when the external COP layer is damaged. This significantly enhances safety in handling toxic pharmaceuticals, a feature that single layer plastic vials cannot offer.”

November 28, 2011 Eastman expands medical portfolio

Theo Wubbels, medical market development manager EMEA Eastman said: “By continuing to leverage our industry understanding, along with extensive design, engineering and manufacturing expertise, Eastman provides practical material solutions that help its customers shape what’s next in rigid medical packaging.”

ON THE PULSE

The latest trends were also presented by Engel during a series of talks aimed to give moulders the competitive edge without compromising on quality. Christoph Lhota, vice president of the business unit medical at Engel, explains more, “The handling of thin cannulas with a diameter of 0.3 mm plus orifice needs is extremely delicate since there is no bending and damaging of the tip allowed. Even a slight damage of the sharp tip would result in increased pain during the puncture. “ He continued, “The fully automatic needle handling is utilised for the manufacturing of prefilled syringes, where the traditional glass barrel is substituted by plastic. Furthermore, the utilisation of plastic instead of glass opens the opportunity to overmould the cannulas instead of the exiting glueing process. This substitution of the gluing process by overmoulding helps to remove the glue itself from the product and as a consequence there is no glue in touch with the sensitive drug. The use of the six axis robot will help to eliminate human errors and reduce bad products as a result.”

27:01:2012

PREVIOUSLY ON MPN MAGAZINE.COM January 11, 2012 New UK medical show attracts keen interest

Colin Robinson, Event Sales Manager for Mediplas commented, “Interest in the show launch has been high as evidenced by the initial exhibitor take up and the additional interest shown by our industry partners in getting involved and supporting the event.“

IMAGE: ENGEL’S E-MOTION 200/100, EQUIPPED WITH AN INTEGRATED STAUBLI ROBOT

January 16, 2012 Gabriel Chemie achieves ISO13485

Gabriel Chemie CEO, Rodolfo Santa Olalla, said, “We are proud to have received this certificate. Once again we have demonstrated to our customers that our products and processes are internationally recognised as of the highest quality.”

January 17, 2012 Lubrizol establishes external orthopedic and wound care RD partnershiP

Deb Langer, Lubrizol general manager in lifescience polymers said, "Developing this relationship with ABIA will provide Lubrizol the opportunity to better understand a patient's needs in order to design and develop effective polymer solutions."

24 FEBRUARY 2012/ MPN /7

ON THE PULSE ON THE PULSE | News from the industry

M&A here to stay in Medical Device Outsourcing Medical device outsourcing is still in its infancy compared to other more mature industries like automotive and consumer goods. OEM support of the outsourcing trend in med devices will continue. The advantages are cost containment, flexibility, speed to market and leveraging of (supplier) capabilities, among others. Looking at some statistics only tells part of the story, while the rest of the story can be seen looking behind the numbers. Global medical device spending eclipsed $230 billion (USD) in 2010, and in the largest market, the US, spending is forecast to reach close to $45 billion USD in 2017 according to GIA, Inc. (research group). While 2011 overall healthcare spending grew at the smallest rate in decades, strong growth is predicted in the medical device markets for the foreseeable future. This growth is fueled by a global aging population, rapid middle class growth and access to healthcare in developing (BRIC) countries, and continued increases in government and private healthcare spending, among other factors. According to Ernst and Young’s 2011 Pulse of the Industry, Medical Technology report, some of the same trends that are challenging the industry

By: Mark Bonifacio, President Bonifacio Consulting Services, LLC

are the ones propelling it. The movement to comparative effectiveness research to measure improved patient outcomes is pushing us to a future where a company’s success or failure will rely on its ability to prove better health outcomes for patients and for the broader health system. As these statistics drive the medical device market, the growth in the outsourcing of components, subassemblies, packaging and other services will continue to grow at an attractive rate. Outsourcing providers (contract manufacturers and service providers to OEMs) will need to consider this

Sealed Air has announced the purchase of the Costa Rican operation of Advanced Thermoforming Enterprise (ATE), a privately-owned medical thermoforming company based in California, USA. The business will be integrated into Sealed Air’s existing Medical Applications business unit. ATE’s Costa Rican operation was started in 2005. The company is dedicated to custom design thermoformed parts for the medical,

Sealed Air acquires Costa Rican thermoformer

carefully as they access their strategies and portfolios. Medical device OEMs are looking to consolidate supply base and reduce the number of suppliers. While there has been some consolidation in the world of Medical Device Outsourcing, it still remains fragmented, with few large global players, especially compared to peer groups. A few examples of recent consolidation in the industry include, Vention, Accellent, Greatbatch Inc, Symmetry, Vesta and Helix Medical to name a few. Adding vertical capabilities and global footprint are two common strategies to growth through acquisition. The med device outsourcing market will continue to consolidate to respond to market needs. Consolidation will promote accelerated time to market, greater returns on invested capital, and transformational innovation while maintaining high quality and patient efficacy. 2010 and 2011 were active years from an M&A standpoint, 2012 should continue this trend. Acquisitions and a good acquisition strategy continue to be an effective means for outsourcing companies to expand their offerings, capabilities and global operational reach while delivering exceptional value to their customers. In 2012, M&A is here to stay, and the future looks bright.

pharma and bio-pharma markets. It has Class 8 (100,000) cleanroom facilities and the site is ISO 9001 certified for medical device packaging. Teresa Preskar, VP and General Manager, Sealed Air Medical Applications said, “ATE enjoys excellent business relationships in the country and this site will become a key element of Sealed Air Medical’s strategic expansion into Central and Latin America.” www.sealedairmedical.com

Clean. Especially in sensitive sectors such as medicine or optics, equipment must be 100% reliable. This begins with production of the relevant high-quality plastic parts. With us as your partner, you are always on the safe side: thanks to many years of experience with comprehensive clean room applications and specially-equipped ALLROUNDER injection moulding machines – also supplied in unique stainless steel versions. With us, everything runs cleanly from the outset. So that nothing can go wrong later.

ARBURG GmbH + Co KG Postfach 11 09 · 72286 Lossburg Tel.: +49 (0) 74 46 33-0 Fax: +49 (0) 74 46 33 33 65 e-mail: contact@arburg.com ARBURG Ltd. · Tachbrook Park Drive · Warwick CV34 6RH · Tel.: +44 (0) 1926 457 000 · Fax: +44 (0) 1926 457 020 · e-mail: uk@arburg.com

www.arburg.com

2012 13-15, March # 6511 th o o B , Hall 6 any rt, Germ Stuttga

COVER STORY

Innovative Polymer Compounds (IPC) Ltd works closely with the CRANN institue in Dublin.

Compounded Interest: The Cleverest Compounders in Town

- Intelligent compounding shines from Irish polymer compound supplier - Smarter Devices deserve Smarter Compounds - Working closely with Ireland's leading research institutes - ISO 13485 certification due in April

Innovative Polymer Compounds (IPC) has been on something of a surge since its inauguration in 2008. The specialist in medical grade compounds has made a name for itself by delivering on some highly innovative projects. Enriched by its strong working relationship with Ireland's leading research facilities — CRANN at Trinity College, Dublin and CCAN at Tyndall National Institute, University College Cork — Innovative Polymer Compounds (IPC) offers OEMs some serous knowhow in medical grade compounding. Now, just four years on, it is months away from getting its ISO 13485 certificate, has a new strap line summarising its market leading intelligence in polymer compounding, and has a stand at Europe's leading medical device trade show, Medtec in Stuttgart in March. To find out more about this vibrant new company, Medical Plastics News editor Sam Anson caught up with David Howard, Innovative Polymer Compounds (IPC) Sales and Marketing Director. Sam Anson: Your new strap line "Smarter Devices deserve Smarter Compounds" is a catchy phrase. I've seen your compounding line and it's certainly a smart set up. But people make the difference to a compounding line. Tell me about your team? Our new tag line mirrors the range of polymer compounds and projects Innovative Polymer Compounds (IPC) has worked on in collaboration with Ireland’s leading research institutes in support of the large number of Medical Device OEM’s here in Ireland who carry out R&D in addition to their extensive manufacturing capabilities. Innovative Polymer Compounds (IPC) has been able to build on our already extensive knowhow in terms of polymer compounds used in devices, and in a relatively short period of time (first production in September 2008) with the very best in the industry – we produce over 450 new compounds across a wide range of polymers and additives. This is

testimony to the great work carried out by our technical team – Joe Molloy – Technical Director, and Declan Thornton Process Engineer. Innovative Polymer Compounds (IPC) has been built on the strong foundations of its JV partnership – Associated Plastics of Ireland API with 30 years compounding experience, and NCC, with over 15 years in offering engineering polymer solutions and service to the device sector...this is not to say that we haven’t been involved in some very steep learning curves on certain materials! However our customer base has worked very closely with us, and we have been able to reward them with rapid delivery times – in one instance 7 hours from order to delivery – to support their R&D efforts. Quality, attention to detail, and rapid responses to exacting customer requirements are what make Innovative Polymer Compounds (IPC) tick. Our rapid response ethos has been reinforced with our ability to work with rapid prototyping / tooling companies on our customers’ behalf, to offer not only the tooling within a number of days, but to have the customers’ polymer compound delivered to them in the same timeframe. Time to market is now a major pressure on all OEMs, and the Innovative Polymer Compounds (IPC) service is key in making this happen for them. Sam Anson: I hear CRANN mentioned a lot. Tell me more about your relationship with them and how your expertise has been used in developing new polymer solutions. CRANN is a key partner for Innovative Polymer Compounds (IPC), in bringing a wealth of technical and diagnostic support for our compound development programmes. CRANN’s state of the art research centre into which they have invested €180 million, together with government R&D funding will help Innovative Polymer Compounds (IPC) in

COVER STORY INNOVATIVE POLYMER COMPOUNDS (IPC)... is a specialist compounder of Medical Grade Engineering Polymers based in Kilbeggan, County Westmeath close to its Irish customer base of Medical Device manufacturers. Its modern manufacturing facilities allow for industry leading delivery times as well as flexible small lot batches. Set up in 2008 and certified to ISO 9001, IPC processes polymers from Arkema, Lubrizol, BASF, EMS, DuPont, Evonik and Solvay. The company performs its own colour matching using a base range of FDA approved pigments which achieves tighter and more consistent colour tolerances as well as short lead

developing new material offerings to the medical device sector. Medical devices, and the materials associated with their production is by its nature a long game, in many instances years from inception to commercialisation on a long and winding road. However, we are mindfull of the fact that Innovative Polymer Compounds (IPC) must be at the cutting edge of polymer and material science in order to offer the sector the Smarter Compounds for the Smarter Devices our customers are developing. CRANN is instrumental to Innovative Polymer Compounds (IPC) in making this happen. Sam Anson: So what about the future? What kind of investment are you looking at adding? On top of the considerable investment to date, Innovative Polymer Compounds (IPC) is looking at significant capital investment in

12/ MPN /FEBRUARY 2012

times for coloured compounds to Pantone, Munsell or RAL references. The company is a joint venture company between a polymer compounding firm (Associated Plastics of Ireland Ltd) and a polymer and chemicals distribution company (National Chemical Company Ltd). Both organisations are well established, each with over 30 years experience in the polymer industry. For more information please contact David Howard: T: + 353 57 9 333 690 M: + 353 87 258 7491 E: dhoward@ipcpolymers.ie W: www.ipcpolymers.ie

2012 which will further enhance our state-of-the-art facility â&#x20AC;&#x201C; we will have an announcement on this in the near future. We continue to add additional test equipment in our lab and have recently installed Shore Hardness testers, HDT apparatus, Density Gradient Columns among others to enhance our testing capabilities. In response to unacceptable lead time on master batches from the industry, we decided in 2011 to bring colour matching, and master batching in-house, under our own control using a range of FDA approved pigments. Our customers can now enjoy rapid colour matching and delivery of compound quantities as low as 5 kilos. Joeâ&#x20AC;&#x2122;s extensive colour matching experience with material compounding at Associated Plastics of Ireland (API), has been a real boon for us in this regard. Our quality commitment will take a further step forward in the coming months with our application for ISO 13485 accreditation to complement our ISO 9001 certification which was awarded to us within six months of start up. Innovative Polymer Compounds (IPC) are at Medtec with Velox on stand 4269.

MEDTEC 2012

The leading trade show for medical technology points the way forward >> MEDTEC Europe is the leading European trade show for the medical industry and with MEDTEC 2012 just around the corner it’s easy to see why. It has been announced that it intends to extend its coverage to include in-vitro diagnostics as well as a number of awards during the course of the three-day show due to take place 13-15 March in Stuttgart. 10 years ago German enterprises working in the field of medical technology generated approximately 5 billion Euros and now according to estimates produced by UBM Canon, organiser of MEDTEC Europe, these sales figures could be approximately 20 billion Euros showing that the industry is growing at a staggering rate. The reasons behind this is the innovations awaiting visitors and exhibitors alike at the trade shows said Gregor Bischopf, event manager responsible for the trade show, when he spoke to Medical Plastics News. Since its launch in 2002, which saw approximately 100 exhibitors, the show has grown considerably to become the industry’s leading European event. Gregor explains why, “There are several reasons, starting, for example, with the choice of venue. As far back as 2002, we opted for Stuttgart — a decision, which proved to be absolutely correct when we look back on things today. “At the time, the medical technology industry in Germany was still a niche sector and consequently did not receive a great deal of attention. In the state of Baden Württemberg, however, there were a fairly large number of enterprises that were active in the medical device sector even 10 years ago. “At the same time, Stuttgart’s proximity to other powerful industrial regions such as Bavaria, South Tyrol, Switzerland and France was clearly an advantage. “However, I consider that the concept and orientation of MEDTEC Europe to be an equally important factor in its success. We do not just place the spotlight on individual technologies or segments of the production process but instead provide a platform for all the products and services involved at all levels of

14/ MPN /FEBRUARY 2012

the medical technology value chain. “MEDTEC Europe is therefore the industry meeting point for all enterprises that are searching for optimised solutions for the manufacture of medical technology products. Over the years new areas of technology have been introduced to the shows, for example cleanroom technology and rapid prototyping, and this trend is set to continue this year with the introduction of IVD, in-vitro diagnostics. Gregor explains that this show will see the introduction of a new focal area in the form of IVD manufacturing. It will reflect developments in clinical diagnostics and life science research sectors of the industry. Gregor believes that there is yet to be a trade show in Germany that is devoted to this sector, meaning that there are interesting opportunities for MEDTEC in the future. “In-vitro diagnostic medical devices are medical products for the non-invasive examination of samples. Thus, for example, they represent an easy way of determining the blood sugar content outside of the body. Ultimately, IVD examinations permit early, targeted treatment. They therefore help ensure that patients are treated quickly and in a way that targets their specific needs, reduce the number of more cost-intensive therapies and shorten periods of hospitalisation. This will reduce the cost of treatment and consequently bring about direct economic benefits for hospitals and health insurance funds. By introducing the area of IVD Manufacturing, we are providing suppliers to the manufacturers of these analytical devices and kits with their first chance to promote products at MEDTEC Europe.” Medical Plastics News is looking forward to attending MEDTEC Europe and has selected a list of profiles from key exhibitors over the next few pages.

MEDTEC 2012

Extruders: Interface Catheter Solutions balloon extrusion guarantee With over 2,100 balloon designs and proven balloon extrusion performance, Interface is a perfect solution to increase your balloon production quality and yield. In fact, we guarantee balloon yield improvement with our balloon extrusion or it's free. Let us provide you with our optimal design, materials and manufacturing expertise to improve your balloon consistency and quality. Interface offers balloon design, development and manufacturing, extruded balloon tubing, custom medical extrusion, plus a comprehensive line of balloon catheter production and testing equipment. Interface is ISO 13485:2003 certified and operates multiple class 100,000 cleanrooms. Stand 6284 www.interfaceusa.com

Medical Grade Polymers: Eastman leads the way in innovations Eastman Chemical is an innovative medical-grade polymers supplier for nonimplantable medical device applications as well as protective and functional packaging, and is committed to the long-term needs of the medical industry. Included in our portfolio is the new medical-grade Eastman Tritan copolyester, which offers a unique balance of design, moulding and end-product 16/ MPN /FEBRUARY 2012

Exhibitor Profiles | GERMANY FOCUS

properties such as clarity, toughness, and BPA-free for medical device applications as an alternative for (T)ABS, Polycarbonate and Polypropylene. In addition the Eastar copolyester 6763 continues to be the industry standard for rigid medical packaging — as it has been for the past 20 years. Eastman Tritan copolyester MP100 is enhanced-performance copolyester that combines greater toughness and higher heat resistance for this market. As part of our commitment to being a leading supplier of polymer solutions, Eastman looks forward with innovations to help you shape what’s next. Stand 6579 www.eastman.com/medical

Medical grade silicones: NuSil technology for silicone compounds NuSil Technology is a global formulator and manufacturer of silicone compounds for the healthcare industries with 30 years of experience. NuSil meets the demands of new and innovative technologies by building on its experience and expanding its products and services to offer exclusive silicone solutions specifically designed for drug delivery and combination medical device products. Silicones possess unique qualities that have made them a raw material of choice for various drug delivery devices and systems in the healthcare industry. Developing novel silicone systems, NuSil offers a complete line of customisable adhesives, elastomers, fluids and gels. Stand 4651 www.nusil.com

Materbatch and compounding: Clariant – an expert in masterbatches Clariant inspires improvements in manufacturing process, product function, and design appeal for medical devices and pharmaceutical packaging with its sector-dedicated MEVOPUR range of controlled, consistent, compliant colour masterbatches and compounds, and additive solutions. Focused on creating confidence and creativity, Clariant’s ISO10993 / USP pre-evaluated standard colour range offers vibrant colours for extra shelf-appeal and differentiation, while helping to minimise risk. A new Cyclic Olefin Colour (COC) range offers glass replacement potential. Also, Clariant’s newly introduced additive range, featuring ISO10993 / USP23 part 87, 88 Class VI biologically evaluated raw materials, brings functionality such as faster cycle times, and effective lubrication and anti-microbial protection. Stand 4457 www.clariant.com

Medical grade polymers: DSM brings new developments to market DSM brings new material innovation to market, through the development of novel materials-based solutions that meet the present and future needs of the medical device and biopharmaceutical industries.

As a leader in biomedical materials sciences with advanced research and development, manufacturing and materials processing capabilities, DSM Biomedical develops products that are available for use in short-term and long-term implantable medical devices. Current product offering includes coatings, drug delivery platforms, ophthalmic biomaterials, biostable polyurethanes and UHMWPE fibre. Stand 6570 www.dsm.com

Medical grade materials: Invibio Biomaterial Solutions Invibio is a global marketleading provider of implantable polyetheretherketone (PEEK)based biomaterial solutions for medical device manufacturers. Its category-defining biomaterials include implantable-grade PEEKOPTIMA, MOTIS and ENDOLIGN polymers and medical-grade PEEK-CLASSIX polymer. In addition, our unique Custom Solutions services help device companies optimise each stage of product development from concept to commercialisation. By collaborating with customers to streamline, manage or outsource critical processes, Invibio ensures your success by creating efficiencies and improving outcomes. You save valuable time and resources through Invibio’s vast array of specialised knowledge, processing technologies and capacities. Booth 6148 www.invibio.com

MEDTEC 2012

Contract manufacturing: Complete value chain for complex medical devices and disposables made of plastics Phillips-Medisize Corporation will be presenting versatile solutions for plastics products in medical technology and diagnostics. The company will be demonstrating a wide range of products from peristaltic pumps, titration plates and mixing-injectors to complete sets for MDDapplications, for instance for eye contact rinses. Also on show will be a peristaltic pump, where a tube is being actuated by contraction, to inject, for instance, a contrast medium into a patient’s vein. The industrialisation process took place within the company, that is from the prototype right through to the injection moulded and ultra sound hermetically sealed pump. Other exhibits include a bone cement-mixing gun, complete transfer systems including tube sets. In the sector disposable diagnostic devices, PhillipsMedisize will exhibit a titration plate with 1536 bores for polymerase chain reaction in DNA replication (PCR). Stand 4135 www.medisize.com

Medical grade polymers: Ideal implantable material from Evonik Germany-based Evonik is one of the world leaders in specialty 18/ MPN /FEBRUARY 2012

Exhibitor Profiles | GERMANY FOCUS

chemicals. With decades of experience in high-performance polymers, we supply specialty materials for the medical sector. Our high performance polymers are used in a wide range of applications, including fluid delivery systems, surgical instruments, and various other devices & equipment. The special combination of properties in VESTAKEEP PEEK polymers makes them the material of choice for implants. We support our customers from start to finish in their search for new areas of innovative applications. Stand 6537 www.evonik.de

Contract manufacturing: Tubular Metal Components MicroGroup, Inc. established in 1971, is well known for its outstanding stainless steel tubing, as well as precision machined components and assemblies within the medical device industry. From initial concept and prototype fabrication, through qualification and validation, to turnkey production — MicroGroup works smartly and efficiently to satisfy customer needs on time. The product range includes standard tubing, bar stock and wire made of stainless steel, titanium and nickel alloys. A broad range of capabilities such as cutting, centreless grinding, redraw to shape and size, straightening and bright annealing enable MicroGroup to easily fulfil any customer request. Stand 6111 www.medneteurope.com

polymer formulations for implants, and drug/polymer blends for oral, film and fibre drug delivery systems. Foster has two state-of-the-art facilities in Putnam, CT and Las Vegas, NV that are ISO 9001-2008 and 13485-2003 registered. Implantable and drug delivery polymers are custom developed and manufactured in a dedicated, cGMP certified regulated environment.

Medical grade compounds: Teknor Apex exhibits Medalist Medtec will mark Teknor Apex’s first European trade-show exhibit of the comprehensive Medalist range of thermoplastic medical elastomers, comprised of a broad array of styrenic, olefinic, vulcanisate and alloy solutions. Hardness offerings range from ultra soft gels at 25 Shore OO to hard yet ductile compounds at 85 Shore D. Teknor Apex can further broaden customer options by customising the surface aesthetics, haptics, clarity and colour. Most recently, the company has developed three systems for bonding tubing made from its clear Medalist MD-500 Series compounds, the first fully practical alternative to PVC in tubing, to traditional connectors. Stand 6634 www.teknorapex.com

Medical grade compounds: Customised drug delivery polymers from Foster Corporation Foster Corporation provides custom development and manufacturing of polymer blends used in critical medical device and drug delivery applications. These include radiopaque compounds for x-ray visibility of minimally invasive devices, custom coloured polymers for medical trays and handles, bioresorbable and PEEK

Stand 6111 www.fostercomp.com

Contract manufacturing: 2-component injection moulding with TPE sealing element Spang & Brands GmbH has further expanded its portfolio of medical device products and assemblies. The company’s level of know-how in multi-component technology, particularly in maximising specific materials blending and combination, as well as in design optimisation, has been significantly advanced. Products for medical technology and the pharmaceutical industry are the speciality of Spang & Brands, based in Friedrichsdorf, Germany. The provider of complete solutions is constantly finding new paths. On display is a state-of-the-art single-use colonoscope, using inverted sleeve technology and remote control movement flow, not requiring costly anaesthesia, thus pain-free for the patient. The colonoscope has already been approved within Europe and is employed in practice. Accreditation for use in the USA is in progress. Stand 4552 www.spang-brands.de

Exhibitor Profiles | GERMANY FOCUS

MEDTEC 2012

Machinery for packaging: Sealed Air present new heat sealing machine Sealed Air Medical Applications is a global specialist in medical device and pharmaceutical packaging. The companyâ&#x20AC;&#x2122;s Nelipak and Nexcel brands offer superior performance in both custom thermoformed products and flexible films. Products and services on display at Medtec include a new Nelipak heat sealing machine with touch panel controls, password protection and connections for data download M4001, a new pouchmaking film for use on high-speed lines with uncoated papers and the companyâ&#x20AC;&#x2122;s Nelipak Total Validation Service which market leaders, such as Pfizer, have chosen as their preferred method of package testing and validation and have been delighted with the results. Stand 4490 www.sealedairmedical.com

FEBRUARY 2012/ MPN /19

MEDTEC 2012

Laser welding: LPKF Laser Plastic Welding Systems Laser plastic welding scores in the medical sector because the technique is extremely hygienic, particle-free and safe. The compact laser welding system LQ-Vario is designed for the production of small and medium sized batches and will be displayed at MEDTEC. An integrated rotary indexing table enables components to be placed and removed during the

process. Special version LQ-Vario MF ensures even complex welding contours, such as those in micro fluidic components, due to a high performance fibre laser. At scanner-based system LQIntegration the laser source and the control unit are housed away from the head in a separate control cabinet â&#x20AC;&#x201D; ideal features for integrating into production lines. Stand 4669 www.laserquipment.de

Packaging machines: MULTIVAC further expands its activities for the medical and pharmaceutical industries MULTIVAC is showing its extensive range of packaging machines and integrated packaging solutions for the medical and pharmaceutical industries. The packaging machines fulfil the high requirements of the medical products industry. MULTIVACâ&#x20AC;&#x2122;s portfolio of thermoforming packaging machines for the medical and pharmaceutical industries comprises the R 535, R 245 and R 145 models. At

20/ MPN /FEBRUARY 2012

MEDTEC the company will be showing the R 145 compact model, a particularly efficient entry-level model for the packaging of sterile medical products in small and medium batch sizes. MULTIVAC will be exhibiting the T 260, which was developed for the packaging of delicate medical products. Stand 4374 www.multivac.com

Exhibitor Profiles | GERMANY FOCUS

Medical grade polymers: Mediprene TPE for medical device applications ELASTO will be showcasing its Mediprene range of thermoplastic elastomers (TPE) for medical device applications. Mediprene TPEs offer numerous advantages for the medical device designer; they are resistant to many fluids used in the healthcare environment and are sterilisable with gamma, EtO and steam. Representative grades have passed cytotoxicity tests according to ISO 10993-5 and biocompatibility tests according to USP Class VI. Mediprene TPEs are PVC, silicone and latex free, making them allergen free and a viable alternative to PVC based compounds. Mediprene TPEs are available in a range of hardnesses; from a gelsoft zero shore A material through to 62 Shore D. For overmoulding applications, Mediprene offers grades with excellent adhesion to a variety of substrates including PP, PE, ABS, PC, PETG and SMMA.

Netstal customers set a high value on the companyâ&#x20AC;&#x2122;s continuous drive to innovate, excellent service and efficient, high-performance engineering solutions, especially for the beverage, packaging and medical technology industries. The Netstal brand, embodied by the Netstal company with its long engineering tradition in NĂ¤fels, Switzerland, has been part of the KraussMaffei Group since 1992. Stand 4511 www.netstal.com

Contract manufacturing: EPflex EPflex Feinwerktechnik GmbH is a DIN ISO 13485 certified OEM manufacturer of metal components for medicine-technics and is specialised in manufacture Nitinol-guidewires in all variations. The product range of EPflex includes guidewires, Nitinolstonebaskets, stylets, hypotubes, customer-specific special products and recently also polymer and hydrophilic coatings. Stand 6237 www.epflex.com

Contract manufacturing, coatings: AMB leading the way in hearing aid supply

The Netstal product brand stands for first-class, highperformance, high-precision injection moulding machinery and system solutions.

plastic parts. Processes comprise of injection moulding, also in cleanroom class 8, PVD processes, vacuum metallisation for EMC-shielding, decoration and reflection, sputtering for reflection and other applications, wet painting in three robot lines and assembly of products, ESD area available. The integration of our production processes provides cost-efficiency by means of effective product development, production, logistics and the procurement of functional moulding and production tools. Stand 4466 www.amb.se

Stand 6359 www.elastotpe.com

Machinery: Netstal show precision injection moulding machines

MEDTEC 2012

AMB is a Swedish subcontractor for plastic parts, a coating specialist and assembler. The company is active in many different market fields and is a leading supplier of hearing aid parts, which will be showcased at MEDTEC. AMB offers cost efficient project management, tooling, coating and assembly of devices or disposable

Medical grade polymers: Putnam Plastics advanced solutions for minimally invasive devices Putnam Plastics Corporation develops and manufactures the most advanced solutions for minimally invasive devices from the widest range of extrusion, finishing and polymer technologies, including thermoplastics, fluoropolymers, PEEK and polyimide. For example, our Tri-Tie continuous process builds threelayer composite guide catheter shafts without manual assembly for improved product reliability and lower cost. Putnam offers custom prototype development through manufacturing of single lumen, monofilament, multi-lumen, coextruded, variable durometer, braided, coiled, wire jacketing, bumped and tapered extrusions. Finishing operations include printing, tipping, machining, welding and moulding. For nearly 30 years, Putnam Plastics has been recognised as a one-stop-shop for medical tubing components. Stand: 6401 www.putnamplastics.com

Full product development: Gerresheimer Medical Plastics Systems Gerresheimer Medical Plastic Systems is an international acting development partner and injection moulder for Medical Plastic Systems. From the first product concept to the delivery of the finished product, Gerresheimer Medical Plastic Systems performs all services: product design, product development, engineering, mouldmaking, automation engineering, large-series and smallseries production (in cleanrooms if required) under FDA/GMP conditions, product finishing, manual, semi-automated and fullyautomated assembly as well as packaging and logistics. Six production sites in Germany, Switzerland, the Czech Republic, USA, China and Brazil offer local manufacturing capacities. However, all-important cross-sectional functions up to the high-volume production start of the product are summarized under the roof of our Technical Competence Centers in Germany and USA. Stand 4759 www.gerresheimer.com

Contract manufacturers, moulds: KEBO AG exhibits high precision moulds For over 30 years KEBO AG has manufactured high precision moulds for the medical sector. It is a family enterprise with a focus on understanding customer requirements, the philosophy of the company being to understand the whole manufacturing process, the result of which is clearly visible in the capability of their mould tools. The advantages of KEBO AG mould tools for the medical moulder include higher cavitation and a shorter cycle times compared to current production. The secret to this is its in-house designed and built hot runner system including the amazing star gate nozzle. Stand 4111 www.KEBO.com JULY 2011/ MPN /21

MEDTEC 2012

Component suppliers: Qosina components to the medical industry Qosina is a worldwide supplier of thousands of stock OEM components to the medical and pharmaceutical industries including connectors, luers, caps, clamps, adapters, stopcocks, valves, swabs, spikes and tubing. Qosina offers free samples, low minimums and Just-in-Time ( JIT) delivery. Purchasing from Qosina saves you time and money by eliminating tooling costs and providing immediate delivery of in-stock solutions based on the specific needs of your project. The company can modify any existing component to meet customer needs or build new tooling to meet the exact requirements. It is also ISO 9001 and 14001 certified. Stand 6321 www.qosina.com

Machinery: Vision Engineering is showcasing its new dual measuring system Vision Engineering will be showcasing Vision Engineering’s new Swift Duo and will be demonstrating its full range of optical and video measuring solutions and award winning stereo microscopes. Swift Duo is the first video measuring system to incorporate an ergonomic measuring microscope. Now, in addition to the speed and simplicity of a video measuring system, previously difficult-to-view 22/ MPN /FEBRUARY 2012

Exhibitor Profiles | GERMANY FOCUS

samples can also be measured and inspected on same system, in the same routine, by the same operator. Designed as a powerful yet simple video measuring system, Swift Duo provides fast and accurate measurement of both routine and complex precision component parts, suitable for both shop floor and manufacturing inspection applications. From simple singlefeature operation to multi-point video edge detection measurements, Swift Duo combines amazing simplicity with a comprehensive array of video measurement tools. Stand 6718 and 8141 www.visioneng.com

Machine manufacturers: Kiefel to present innovative line for production of IV bags with integrated filling Kiefel is a world leader when it comes to the design and manufacture of machines used to process plastic foil materials. At MEDTEC the company will be showcasing an innovative line for the production of IV bags with integrated filling. Thanks to its newly developed IV Express, welding-technology specialist Kiefel meets the needs of the market to perfection. The compact, stainless-steel design reduces the area required for setup, while ensuring maximum output rates with minimal occupation of floor space. The system permits the flexible production of different sizes of IV (intravenous) bag, in 2x, 4x and 6x configuration, along with multichamber bags with peel-open seal. Maximum productivity can be achieved with a minimum of retooling, as the system works in short production cycles with high processing reliability. Stand 4366 www.kiefel.com

Contract manufacturingcomponents: Filtrona Porous Technologies Filtrona Porous Technologies is a developer and manufacturer of custom fluid handling components engineered from bonded fibre, polyurethane foam and porous plastic technologies. Our components represent leading technology used in medical, surgical and diagnostic devices that require the absorption, filtration, transfer, venting or controlled release of liquids or vapours. All products are manufactured from a range of proprietary processes and a broad selection of material choices, both of which enable customised component performance. Our internal development process is designed to meet your performance requirements and create a highquality, innovative product for the market, by leveraging a technical collaboration. Stand 4347 www.filtronaporoustechnologies.com

Materials: WACKER unveils biocompatible, liquid silicone rubber for the production of radiationsterilisable valves WACKER will be unveiling a new liquid silicone rubber for radiation-sterilisable silicone valves used in medical devices. The product available under the name SILPURAN 6610/40, serves in the production of biocompatible silicone valves whose slits do not close up or ‘heal’ during radiation sterilisation.

The new silicone rubber allows such valves to be made without the use of additional auxiliaries. For instance, silicone valves ensure that infusion systems administer the correct dose of liquid medication. Medical equipment for administering liquid medication frequently employs valves made from silicone elastomers. These offer high dosing accuracy, are biocompatible and can be very readily sterilised on account of their resistance to heat, radiation and chemicals. Stand 2538 www.wacker.com

Machinery: Wittmann Battenfeld will show allelectric MicroPower and EcoPower series Wittmann Battenfeld, a company of the Wittmann group based in Kottingbrunn, Lower Austria, is a leading manufacturer of injection moulding machines and equipment for the plastics industry. The product portfolio of the company comprises injection moulding machines within the clamping force range from 5 to 1.100 t for all kinds of applications, among them the all-electric machines of the MicroPower and EcoPower series, which are especially suitable for medical applications and will be showcased. With its own sales and service companies as well as representations in about 60 countries, Wittmann Battenfeld provides optimal support to its customers. Stand 6161 www.wittmann-battenfeld.com

DESIGN FOR LIFE

Truject EpiPen | DESIGN FOR LIFE

Auto-inject Truject EpiPen uses

colour

for improved delivery

esigning new products for use in the medical industry can sometimes be a tricky business, especially when considering the correct materials for the job. One of the most challenging areas to consider, according to many designers, is the use of colour within the design and its suitability for use in long-term and short-term medical devices.

This is an area which Team Consulting knows all too well when considering new design concepts, most recently in its latest product; the next-generation EpiPen auto-injector-Truject. Team Consulting is a world-renowned developer of medical products based in a 13th century barn in the village of Ickleton, just outside Cambridge, UK, the company believes that maintaining strong relationships with its clients has been a major contribution to the growing success in the development of its medical devices. Working closely with an in-house team of designers and engineers, Team prides itself on offering clever, robust engineering, creative design and practical processes to help bring commercially successful products to market that make patients’ lives easier for the future. Now with the introduction of Truject — the next generation EpiPen — Team talks openly to Medical Plastics News about the challenges faced when designing a product that is not only innovative in its concept but is also appealing to the eye.

24/ MPN /FEBRUARY 2012

David Robinson, design consultant at Team, explains, “As consumers we know that the way a product looks and feels is important to purchasing decisions and that it plays a significant role in determining the emotional connection between us and the product. In the medical sector this emotional connection could provide many benefits to the manufacturer and, crucially, the patient.” Team also understands that colour can be a critical element when it comes to the intuitive usability of a medical device, and hence that correct choice of colour can be extremely important for an emergency use device. Yet many materials do not currently meet the required certifications for use in medical applications and an even smaller amount can be used in the delivery of drugs. “The new EpiPen auto-injector aesthetic was carefully crafted to evoke an emotional response from users. EpiPen is not designed to fit with current fads but to look like an emergency product. It communicates its function quickly and effectively to the user using visual components. Colour is an important element in this, as it subconsciously triggers emotions, memories, ideas and thoughts based on past experience. Colour guidance material, supported by scientific research, allows us to select colours appropriate to the user requirements rather than relying on subjective opinions,” Robinson continued.

[below] Truject — the next generation Epi Pen auto injector invarious colour combinations

Working closely with colour manufacturers to define a standard colour range whose ingredients have been biologically evaluated to medical standards such as ISO 10993, enables Team to select colours that are already approved for medical use. This was no different when looking at the new design concept for the Truject, which includes vibrant colours within the finished device. Chris Hurlstone, head of technical development at Team, explains, “Meridian Medical Technologies came to Team to develop their next-generation auto-injector, which would offer integrated automatic needle protection and be easy to use in an emergency situation. This is where the colour combinations incorporated within the design can play a significant role for those who need to use the device quickly and effectively. “Team were chosen as we offered the wide range of skills from human factors and industrial design, from concept and prototyping through to engineering, industrialisation and design verification and validation.” The EpiPen works by penetrating the skin to deliver a life-saving drug during anaphylactic attack, so Team had to design a device using robust mechanisms that would successfully and reliably deliver intramuscular injections while also offering improved usability and robust automatic sharps protection. One of the main areas of improvement comes with easy-to-read on-board pictorial instructions and clear colour-coding that encourages correct orientation as well as the device being designed to cover the needle before and automatically after usage. Additional features include a redesign of the shape to help communicate the needle end, which could also prevent the device from rolling off surfaces and aids grip.

Another significant change to the design was to replace metal components with plastic ones resulting in a more robust and automated manufacturing process. Chris continued, “The challenge for us was to develop alternative component designs in plastic that were capable of withstanding the extraordinary stresses. Working within extremely tight constraints and using readily available material grades, a lot of research went into getting the correct solution using analytical, empirical and rapid prototyping techniques. Mould tool design was also a really important factor but working closely with our suppliers helped make this process much easier.” Steve Augustyn, head of mechanical engineering at Team, says that testing and working closely with suppliers to maintain good relations is a key part of any design project. He said, “Building relations with suppliers is essential and talking to them on a regular basis helps them understand our requirements when we start to look at the design concept for any medical device. “Developing products within the medical sector presents a number of unique challenges and constraints which requires us to have strong relationships with our suppliers, which is just as important as the relationships we have with our clients” he continued. Team worked closely with Meridian’s manufacturing sites and suppliers, providing efficient handover of design documentation and key technical files as well as developing a production design verification plan, supporting the build and validation of the product moulds and automated assembly equipment. www.team-consulting.com

FEBRUARY 2012/ MPN /25

DESIGN FOR LIFE

Colours are coming, and not in small measure ibrant colours are becoming more and more important in medical device manufacturing. Leading device producers are adding colour for aesthetic flair as well as practical benefits. But in order to mass produce devices with high colour content on a mass scale, OEMs need to measure the various shades they use in order to ensure they achieve consistency across products.

Colour measurement (and by extension consistency) is particularly important in devices which rely on the colour of the plastic for its practical application, for example, the transparency of a piece of tubing where inspection of the contents is key to the patient’s health — or the for colour coding of devices, such as our EpiPen example in the previous artcle, where inconsistency of shades could lead, at best, to confusion for the user or at worst, to incorrect usage. In order to get the lowdown on colour measurement, we caught up with Peter Smith, the UK sales manager of XRite — a leading colour measurement equipment manufacturer — to find out more about why consistent colours are key to plastic medical device OEMs. “Essentially, the only way to measure a colour is by putting a number against it and then comparing this against a set of industry standards,” said Peter when asked about the overall approach. He added, “Importantly, once these numbers have been decided, it’s key to establishing the tolerance against these numbers that the coloured component of the device must meet”. Armed with these numbers, device designers and manufacturers must ensure that their products consistently meet requirements. And these requirements may be for a variety of reasons. Peter Smith explained: “Establishing realistic and acceptable tolerances for colours in medical devices is absolutely key to achieve colour consistency. Not only is inconsistent colour perceived by users to be poor quality, but it can lead to confusion for users, who may have to double check the device’s application.” 26/ MPN /FEBRUARY 2012

[above] Color i5 Benchtop Spectrophotometer — A rugged design for accurate, high-volume production measurement instrument for evaluating the widest available range of sample sizes, shapes, textures, and opacity levels.

One of the most common applications for X-Rite’s colour measurement equipment in the UK is in asthma inhalers. Available on prescription, these devices are made from three or four plastic components, some of which are the same colour. Peter reiterated: “In asthma inhaler devices, colour matching is absolutely key, because there are large volumes of components being produced for people who rely on these devices for their health. The tolerances in the shades must be small enough so that the components match — and this must be met by the plastic processing team — otherwise devices begin to look like patchwork quilts after assembly, and this makes patients question the overall quality.” In other areas of medical plastics, colour measurement equipment and software is being used to match colours to skin in prosthetics as well as in anti-counterfeiting pharmaceutical products. For more information about X-Rite’s colour measurement products contact Peter Smith at X-Rite.

'COLOURS OF HEALTH & CARE' — NEW PLANNING MANUAL FOR DESIGNERS IN THE Whether for a HEALTH CARE medical practice, SECTOR a hospital or a rehabilitation clinic, designers in the health care sector will now find substantiated information on the psychology of colour in the planning manual ‘Colours of Health & Care’.

On 384 pages, a total of 120 health-related adjectives are coded in 340 RAL DESIGN system colours. The manual comes with a new RAL colour fan deck that clearly and precisely defines the 120 most important colours of health and care. Axel Venn, professor for colour design and trend scouting with an international reputation, is the author of this new book published by RAL. ‘Colours of Health & Care’ is a true innovation. This reference work provides professionals and amateurs with access to the rules and basics of the effect of colour in the health sector. Fusing colour and aesthetic theory on the one hand, and scientific analysis on the other, the book gives designers, architects, interior designers, marketing professionals and doctors an orientation to the colours of health and care and their various combination options. For this study, the authors asked subjects to associate 120 health-related adjectives with colours and then make their colour selection visible by means of hand-painted mood

DESIGN FOR LIFE boards. For example, ‘healthy’ was primarily associated with green, but blue and yellow also played a role. The results of the study were ultimately translated into colours of the RAL DESIGN System. Numerous drawings and photos illustrate the colour associations and make the ‘colours of health & care’ comprehensible in concrete example applications. The book also contains a practical section: using the enclosed template, users can directly experience selected colour combinations. In a new RAL colour fan deck, RAL has compiled the 120 most important defined colours for designing with colour in the health care sector. In addition to the RAL colour codes and a descriptive colour name, the colours come with information on their popularity and design-related applicability. The colour fan deck is chromatically arranged to follow the design principles of harmony, balance and similarity. Four detachable colour chips for each colour make it easy to use. You can purchase ‘Colours of Health & Care’ (published in German and English) in the RAL Colours online shop at www.ralcolours.de.

FEBRUARY 2012/ MPN /27

MD&M WEST

MD&M | INTRODUCTION

Plastics Play Their Part at MD&M West n February 14-16, 2012, Anaheim Convention Center near Los Angeles will play host to Medical Design & Manufacturing (MD&M) West, one of the world’s largest trade shows for suppliers to medical device OEMs. The show is part of a series of international trade shows organised by UBM Canon, the West part of the title referring to the fact that this event is held on the west coast of the USA.

The 2012 show will house around 2,700 exhibitors spanning every aspect of medical device manufacturing including raw materials, equipment, manufacturing services and finished products. Medical plastics companies are particularly well represented given the important role that plastic plays in the industry. Furthermore, many suppliers to the US medical plastic industry are leading the field globally. Indeed, according to the MD&M West brochure, 50% of all medical devices sold worldwide are produced in the USA. And plastic plays a major part. In recognition of this trend, the SPE Medical Plastics Division is hosting a two-day conference at the event. The first day is on advanced materials for use in medical devices and the second day is on advanced processing and manufacturing. For more information, see opposite.

In this preview, we bring you just a small sample of some of the most interesting medical plastics suppliers. If you’re unable to attend, have a look through these previews and drop us a line for more information — we’ll be there in full force, talking to as many of the exhibitors as possible.

Smooth Operator: Smooth and standard corrugated tubing for gas transfer from Canada GlobalMed Inc, based in Ontario, Canada, is a leading manufacturer of corrugated medical tubing. As part of our MD&M West preview, we caught up with GlobalMed’s VP Sales, John Seniuk, to find out more.

SAM ANSON: What can

SAM ANSON: You're obviously one of the strongest OEM

we tell our readers that will make them make a bee line to your stand at MD&M West?

suppliers in medical tubing. What do your customers say is your biggest strength?

JOHN SENIUK: GlobalMed

Inc. is an ISO13485 certified medical tubing manufacturer offering a full line of tubing that is used for anesthesia, ventilation, respiratory, smoke evacuation and CPAP. Our product line consists of standard corrugated tubing as well as smooth corrugated tubing. We have a full line of fittings to compliment our tubing, and we offer assembly services to provide added value for our clients. 28/ MPN /FEBRUARY 2012

JOHN SENIUK: Our product development service is second to none.

GlobalMed has a full engineering and technical team dedicated to developing products that are specific to our clients’ requirements. GlobalMed prides itself on outstanding customer service, and on-time delivery. Readers are encouraged to visit our booth #664, to talk to our team and see for themselves why customers in over 30 countries believe GlobalMed is the best choice for their tubing requirements. For more information, contact John Seniuk ( john@globalmedinc.com) or go to www.globalmedinc.com.

MD&M PROFILES SESSION BEGINS AT 9:00AM

Session 104 - Advanced Materials Monday, February 13, 2012 9:00–9:30am

Moderators:

Peter Colburn, Evonik Cyro LLC Margie Hanna, Czuba Enterprises, Inc.

SESSION BEGINS AT 9:00AM

Session 204 - New Processing Technologies

Moderators:

Tuesday, February 13, 2012 9:00-9:30am

1. Polyolefins For Blow-Fill-Seal Pharmaceutical Packaging: A Case Study

1. Advances in Injection Molding of Biocompatible Fluoropolymers

Jill Martin, Senior Development Engineer, Dow Chemical Company

Ken Kelly, General Manager, Performance Plastics Ltd.

Mark Bonifacio, Bonifacio Consulting Services John Czuba, CEI

9:30–10:00am

9:30-10:00 am

2. Processing Considerations for Bi oresorbable Polymers in Medical Applications Lothar Kleiner, Volwiler Associate Research Fellow, Abbott Cardiovascular

2. Role of Mechanical Properties in Design Control and Validation Siddharth Desai, VP R&D, I Flow Division of Kimberly Clark Corporation Gary Aurin, Technical Leader, Kimberly Clark Corporation

10:00–10:30am

3. Exciting New Extruded Tubing Materials for Medical Applications Edz Boarini, Sr. VP and General Manager, Teleflex Medical OEM Breakat 10:30amto 11:00am

10:00-10:30 am

3. The Importance of Design and Material Selection for Successful Medical Devices Phil Anthony, President, Design Integrity Breakat 10:30amto 11:00am

11:00–11:30am

4. Device Related Hospital Acquired Infections (HAIs) and a Novel Next Generation Antimicrobial Technology Arjun Srinivas, COO, Innova Dynamics

11:00-11:30 am

4. Qualification of Components for Use in Medical Devices

Scott Young, Senior Director, West

11:30–12:00pm

11:30-12:00 pm

5. The Production and Use of Supported Nano-Silver Particles in Polymer Systems Matt Gande, Principal Technology Specialist II, Medical Device BASF

5. Medical Grade Polyurethanes from Wound Care to Permanent Implants Tony Walder, Manager of Technology, LifeScience Polymers, Lubrizol, Inc.

Lunchbetween12:00pmand 1:00pm 1:00–1:30pm

Lunchbetween12:00pmand 1:00pmpm 1:00-1:30 pm

6. Responsible Approach to Antimicrobials and Materials

6. New Developments in Medical Packaging Materials

Peter Colburn, Director Business Development & Technology, Evonik Cyro LLC

Dhuanne Dodrill, President, Rollprint Packaging Products

1:30 – 2:00pm

1:30-2:00 pm

7. Modification of Silicone Chemistry and its Influence on Release Rates of Active Pharmaceutical Ingredients (APIs) Brian Reilly, Product Director, Healthcare Materials, NuSil Technology

7. New Developments in Medical Micromolding Mark Bonifacio, Principal, Bonifacio Consulting Services

2:00 – 2:30pm

8. Fabrication of Silicone-based Combination Products

Mark Paulsen, Business Development, Specialty Silicone Fabricators Mel Toub, Application Development Manager, Momentive Performance Materials Breakat 2:30pmto 3:00pm 3:00 – 3:30pm

9. Trends in Medical Device Materials and an Introduction to Novel Copolyesters

Ken Breeding, Applications Development, Eastman Chemical Company 3:30-4:00 pm

10. Bioresorbable Polymers for Medical Devices - A (Still) Emerging Field

Richard Meyst, President, Fallbrook Engineering

2:00-2:30 pm

8. Hardware Developments for Machine and Robotic Transfer Systems Stu Kaplan, President, Makuta Technics Breakat 2:30pmto 3:00pm 3:00-3:30 pm

9. The Challenges of Choosing the Right Polymeric Material for Today’s Medical Devices Len Czuba, President, Czuba Enterprises, Inc. 3:30-4:00 pm

10. Process Challenge Device – A Sterility Assurance Validation Tool R. Daniel Webster, CEO, Process Challenge Device Sessionends at 4:00pm

Sessionends at 4:00pm

FEBRUARY 2012/ MPN /29

MD&M PROFILES

Extrusion Machinery: Modular Microextrusion System for Tubing and Fine Wire Jacketing American Kuhne will be running a microextrusion line, including its 13 mm (1/2”) gearless modular microextruder with pressure control, B&H Tool BH25 MicroCrosshead with spiral deflector, 3-ft precision water bath, Conair Medline puller/cutter and Zumbach ID/OD/WALL system. The system will include American Kuhne’s AKcess Level II control system with 19-inch widescreen. The AKcess Level II control system incorporates 3D graphics and includes mobile access via iPhone, iPad, Android and other tablet devices. American Kuhne offers unique modular extruders that enable barrel and screw ‘modules’ to be changed quickly and easily. Modular Microextruders are offered in 13 mm (1/2”) and 16 mm (5/8”) sizes. These machines are ideal for very low output applications where conventional size medical extruders such as a 25 mm (1”) machine cannot be used because the long residence time in the barrel will degrade the polymer. All microextruders include pressure control and servo drive systems. Melt pumps are available as an option. American Kuhne – Stand 2330 www.americankuhne.com

Medical colour masterbatch and performance additives: Clariant Clariant inspires improvements in manufacturing process, product function, and design appeal for 30/ MPN /FEBRUARY 2012

Exhibitor Profiles | LOS ANGELES FOCUS

medical devices and pharmaceutical packaging with its sector-dedicated MEVOPUR range of controlled, consistent, compliant colour masterbatches and compounds, and additive solutions. Focused on creating confidence and creativity, Clariant’s ISO10993 / USP pre-evaluated standard colour range offers vibrant colours for extra shelf-appeal and differentiation, while helping to minimise risk. A new cyclic olefin colour (COC) range offers glass replacement potential. Also Clariant’s newlyintroduced additive range, featuring ISO10993 / USP23 part 87, 88 class VI biologically evaluated raw materials, brings functionality such as faster cycle times, and effective lubrication and anti-microbial protection. Clariant – stand 2245 www.clariant.com

Materials manufacturer: Eastman Chemicals Eastman Chemical is an innovative medical-grade polymers supplier for non-implantable medical device applications as well as protective and functional packaging, and is committed to the long-term needs of the medical industry. Included in our portfolio: new medical-grade Eastman Tritan copolyester offers a unique balance of design, moulding and end-product properties such as clarity, toughness and BPA-free for medical device applications as an alternative for (T)ABS, polycarbonate and polypropylene. Eastar copolyester 6763 continues to be the industry standard for rigid medical packaging — as it has for the past 20 years. Eastman Tritan copolyester MP100 is an enhanced-performance copolyester that combines greater toughness and higher heat resistance for this market. As part of our commitment to being a leading supplier of polymer solutions, Eastman looks forward with innovations to help you shape what’s next. Tritan and Eastar are registered trade marks of Eastman. Eastman – stand 2227 www..eastman.com/medical

and 13485-2003 registered. Implantable and drug delivery polymers are custom developed and manufactured in a dedicated, cGMP certified regulated environment.

Porous Materials: Filtrona Porous Technologies Filtrona Porous Technologies is a developer and manufacturer of custom fluid handling components engineered from bonded fibre, polyurethane foam and porous plastic technologies. Our components represent leading technology used in medical, surgical and diagnostic devices that require the absorption, filtration, transfer, venting or controlled release of liquids or vapors. All products are manufactured from a range of proprietary processes and a broad selection of material choices, both of which enable customised component performance. Our internal development process is designed to meet your performance requirements and create a high quality, innovative product for the market, by leveraging a technical collaboration. Filtrona – stand 2286 www.filtrona.com

Foster Corporation – stand 2301 www.fostercomp.com

Medical grade silicones: Bluestar Bluestar Silicones is one of the foremost fully integrated silicone manufacturers in the world. With over 50 years’ silicones expertise, Bluestar Silicones offers a comprehensive range of silicones products in particular (marketed under the Silbione brand) in the healthcare and medical devices market: liquid silicone rubbers (LSRs), heat-cured rubbers (HCRs), room-temperature vulcanised silicones (RTVs), gels and more. All our silicones are manufactured in a clean environment in North America, Europe and Asia to ensure we meet the appropriate healthcare grade levels of purity and quality, and lot-to-lot consistency. Bluestar – 1761 www.bluestarsilicones.com

Medical grade compounds: Foster Corporation Foster Corporation provides custom development and manufacturing of polymer blends used in critical medical device and drug delivery applications. These include radiopaque compounds for x-ray visibility of minimally invasive devices, custom coloured polymers for medical trays and handles, bioresorbable and PEEK polymer formulations for implants, and drug/polymer blends for oral, film and fibre drug delivery systems. Foster has two state-of-the-art facilities in Putnam, CT and Las Vegas, NV that are ISO 9001-2008

Bioabsorbable polymers and fibres: Poly-Med for implantables Bioabsorbable polymers and fibres produced by Poly-Med are used worldwide in numerous implantable medical devices. Product features include short, medium, and long term bioabsorption profiles and are supplied in polymer granules, micro- mono- and multifilament fibres, textiles, and other forms. Additionally, Poly-Med has the ability to assist with device and textile design and material selection

Exhibitor Profiles | LOS ANGELES FOCUS

to make the best use of these unique materials, as well as perform pertinent analytics to support regulatory filings. Poly-Med has developed and manufactured bioabsorbable polymers, fibres and other constructs for medical devices for more than 18 years. It is ISO 13485 certified and FDA registered. Poly-Med – stand 725 www.poly-med.com

Medical grade polymer solutions: Engineering thermoplastics, TPV alloys, TPEs, polyurethane and PEBA-based compounds, vinyl, colorants, lead-free radiation shielding solutions and antimicrobials PolyOne is a premier global provider of specialised polymer materials, services and solutions. At MD&M West, PolyOne will

be featuring Stan-Tone HC Plus (USP Class VI certified) colorants, Trilliant lead-free radiation shielding solutions, Geon vinyl for medical device housings, USP Class VI-certified polyurethane and PEBA-based compounds from NEU, and WithStand antimicrobial additives and compounds. Key healthcare sub-segments are radiation shielding, catheters, syringes, antimicrobial solutions, medical device housings, tubing, and minimally invasive surgical device housings. PolyOne’s pillars of strength are collaborating to bring value, accelerating speed to market and providing exceptional product performance. PolyOne – 1539 www.healthcare.polyone.com

MD&M PROFILES

Polymers, Prototyping and Manufacturing for Minimally Invasive Tubing Devices: Putnam Plastics Putnam Plastics Corporation develops and manufactures the most advanced solutions for minimally invasive devices from the widest range of extrusion, finishing and polymer technologies, including thermoplastics, fluoropolymers, PEEK and polyimide. For example, its trademarked Tri-Tie continuous process builds three-layer composite guide catheter shafts without manual assembly for improved product reliability and lower cost. Putnam offers custom prototype development through manufacturing of single lumen, monofilament, multi-lumen, coextruded, variable durometer, braided, coiled, wire jacketing, bumped and tapered extrusions. Finishing operations include printing, tipping, machining, welding and moulding. For nearly 30 years, Putnam Plastics has been

recognised as a one-stop-shop for medical tubing components. Putnam Plastics – stand 2301 www.putnamplastics.com

Medical Grade Compounds: RTP Company RTP Company makes customised medical thermoplastic compounds in more than 60 different engineering resin systems for medical device applications. The company provides known biocompatible plastic solutions in colouring, static dissipative and conductive, radiopaque, thermoplastic elastomers, and high-strength and wear-resistant properties. RTP Company – Stands 1784 and 4189 www.rtpcompany.com

FEBRUARY 2012/ MPN /31

MD&M PROFILES

Materials manufacturer: SABIC Innovative Plastics SABIC Innovative Plastic’s exhibit will underscore its broad and growing portfolio of specialised resins and composites that are helping to provide greater portability, antimicrobial performance and improved aesthetics for today’s high-tech healthcare devices. SABIC will also showcase the versatility of its advanced materials technologies, many of which are backed by a comprehensive healthcare product policy, including the introduction of new thermoplastic foam and fibre solutions for applications where filtration and weight reduction are critical requirements. The SABIC exhibit will include on-site application development, product and technical experts who will be available to discuss the latest medical device advances and industry trends in miniaturization and ergonomics. Additionally, the company will highlight a number of new potential applications that demonstrate how its innovative healthcare plastics are raising the bar on device design, performance, sustainability, and usability of new medical devices. SABIC Innovative Plastics – stand 1801 www.sabic-ip.com

Materials manufacturer: Styron’s Polycarbonates and High End Blends Global materials company, Styron, offers a portfolio of resins for the medical markets under the CALIBRE Polycarbonate Resins and EMERGE Advanced Resins 32/ MPN /FEBRUARY 2012

Exhibitor Profiles | LOS ANGELES FOCUS

brands for single and multiple-use devices and equipment housings. Styron’s flagship product, CALIBRE MEGARAD Polycarbonate Resins, uses colour compensation technology to ensure colour stability following gamma- and electron-beam radiation. Its EMERGE polycarbonate blends have advanced chemical resistance properties to resist harsh chemical substances preventing crazing or cracking. Styron’s focus on polycarbonate and high-end blends, allows the company to work intimately with its medical customers — something vital in the medical industry, where understanding regulatory and compliancy issues is critically important. Styron – stand 718 www.styron.com

Contract extruders: Pexco

Tubing supplies: GlobalMed Inc GlobalMed Inc. is pleased to announce that in addition to its already extensive line of corrugated and expandable tubing, we now manufacture a complete line of smooth corrugated tubing products for use in anesthesia and respiratory applications. Their smooth corrugated tubing line includes: CPAP (continuous positive airway pressure) tubing, Hytrel tubing (over-moulded cuffs or integral cuffs), EVA and metallocene. The benefits of their products, they claim, are light-weight, flexible and durable with a smooth interior for optimal airflow. GlobalMed Inc – stand 664 www.globalmedinc.com

Medical grade TPEs: Teknor Apex demonstrates Medalist applications

All you need in contract manufacturing: Martech

At MD&M West, Teknor Apex will exhibit its Medalist range of thermoplastic medical elastomers, comprised of a broad array of styrenic, olefinic, vulcanisate, and alloy solutions. Hardnesses range from ultra soft gels (25 Shore OO) to hard yet ductile compounds (85 Shore D). Teknor Apex can further broaden options by customising surface aesthetics, haptics, clarity, and colour. The company has developed three systems for bonding tubing made from clear Medalist MD-500 series compounds, the first practical alternative to PVC in tubing, to traditional connectors. Another recent development is the commercial use of Medalist compounds for the plunger tips of single-use syringes.

Martech Medical Products is a vertically integrated OEM medical manufacturer providing outsource/resource management for all your medical contract manufacturing needs. We specialise in catheter and device manufacturing, rapid prototyping, extrusion, over-the-needle (OTN) catheters, hemostasis sets, peripherally inserted central catheters (PICCs) and central venous catheters, dilators and tearaways. Services include R&D, tool design and fabrication utilising an onsite tool shop, extrusion, moulding, tipping and assembly. The company has over thirty-five engineers to help in new product design and an experienced regulatory department to assist with product approval.

Teknor Apex – stand 2233 www.teknorapex.com

Martech – stand 2401 www.martechmedical.com

Pexco offers precision thermoplastic medical extrusions produced in class 100,000 clean rooms. The company has FDA registered, ISO 9001-2008, ISO 14001-2004, OHSAS 18001:2007 certified facilities. Capabilities include: summary of process characteristic (SPC) documentation, on line measurement controls, in house wire EDM Cad/Cam system, single and multi-lumen tubing, thermally bonded para-tubing, wireencapsulated tubing, co-extrusions, tri-extrusions, custom profiles, printing, bar-coding, sub-assembly and packaging. Specialising in medical grade flexible or rigid tubing and custom profiles. USP class VI materials include: PVC, Non-DEHP, PE, PP, PU, PC, Nylon, HIS, TPE, TPR, radiopaque and PVC alternatives. Contract manufacturing and general-assembly operations include: specialty cutting, tube coiling and banding, solvent bonding of components to tubing, thermo-bonded tube coiling, champhering and special packaging. KanBan or JIT inventory and shipping programs are available. Pexco’s three Medical manufacturing facilities in Athol Massachusetts; Monterrey MX and Mexicali MX total over 250,000 sq ft and have been servicing medical OEMs and contract manufacturers for over 50 years. Web Industries – stand 1650 www.webindustries.com

Contract packaging and manufacturing: Polymer Science Inc Polymer Science specialises in providing custom coating, converting and packaging solutions for the medical market. Polymer Science is ISO 9001:2008 and ISO 13485:2003 registered and cGMP compliant. Additionally,

Exhibitor Profiles | LOS ANGELES FOCUS

Polymer Science is registered as a medical device and OTC drug manufacturer and packager under the regulatory authority of the FDA. Polymer Science Inc – stand 2374 www.polymerscience.com

Disposables and electro assemblies: Precision Concepts Costa Rica Precision Concepts Costa Rica (PC-CR), together with its sister company Precision Concepts Group, in Winston Salem, NC, is a vertically integrated contract manufacturer of disposable medical devices and electromedical assemblies using certified ISO class 8 (100, 000) clean rooms and controlled environments. PC-CR produces high quality, custom packaged finished goods at a competitive cost. Engineering capabilities include

new product development, die engineering, mould engineering and automation engineering. In medical device assembly the company offers bobbin winding, various testing options, custom packaging, fine soldering and sterilisation management. In stamping they offer high speed Bruderer presses, SPC equipment and 24 hour production capability. In moulding services include single cavity 3-plate design to multi cavity expandable hot runners. Precision Concepts Costa Rica – stand 2275 www.pc-cr.com

Contract micro extrusion services: Precsision Extrusion Precision Extrusion, Inc. is an ISO 9001:2008 certified custom

MD&M PROFILES

manufacturer of close-tolerance, custom-made small diameter tubing including, single and multilumen, coextruded, and single and multi-lumen braided tubing. Materials include PVC, PUR, PA, PC, PE, PEEK, FEP, PLA, Nylon and other engineering resins. Materials can be compounded with barium, bismuth, or tungsten for radiopacity. ID is as small as 0.0025” and walls as thin as 0.002” are possible. PEI is also a premier supplier of acetal mandrel in sizes from 0.015” to 0.235” with/without silicone exterior release layer. We also offer angiographic and guide catheter tubing (welding and tipping, etc.). PEI has the capabilities in prototype and fabrication of subassemblies post extrusion. Balloon sizes range from 0.5 to 50 mm diameter. Operation features in-house tool design and manufacturing for quick turnaround. Precision Extrusion Inc – stand 2161 www.precisionextrusion.com

Offshore contract manufacturing: Sanbor Medical Sanbor Medical is a 22 year old full service US contract manufacturer and device assembler with a high quality and cost effective FDA registered production facility in Xiamen China, providing off shore pricing with on shore reliability. We offer contract manufacturing, production, and assembly services of class I & II devices, including full system box builds, hand held devices, and single use disposables. We also offer assembly and packaging in our class 10,000 clean room along with sterilisation through our FDA registered partners. In addition to finished devices we offer electromechanical sub-assemblies, and plastic moulded omponents. Sanbor Medical is FDA registered and ISO13485 Certified. Sanbor Medical – stand 1972 www.sanbormedical.com

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MD&M PROFILES

Plastic contract manufacturing: Racer Technology Singapore Racer Technology is one of the leading medical manufacturers in the world. It was established in December 1988, specialised in manufacturing high quality precision plastic components and sub-assemblies. Through a systemic understanding of the requirements and target feasibility experiments, Racer’s product design service makes device development more predictable in scope, time and cost. Its disciplined approach to systems engineering, programmatic risk management and detailed design reduces development risk and minimises cost and time to market. As an integrated solution manufacturer, Racer provide 8 services in all thermoplastic related manufacturing, from industrial/mechanical design, CNC prototyping, silicon tool, prototype tool, production tool fabrication, precision machining, precision engineering plastics, EMI/UV/cosmetic spray painting, finishing decorations, ultrasonic welds, ultrasonic cleaning, subassemblies and final package. Racer Technology – stand 405 www.racer.com.sg

Chinese cleanroom contract manufacturing: Sunny Medical Sunny Medical is the leading contract supplier of medical devices in China, including plastic injection moulding and assembly, packaging and ETO sterilisation. We offer OEM, ODM and customised medical devices to worldwide customers, specialising in cardiology and radiology interventional products. All extrusion, mould injection, assembly and packing are in either class 10,000 or class 100,000 34/ MPN /FEBRUARY 2012

Exhibitor Profiles | LOS ANGELES FOCUS

cleanrooms, and sterile tests, positive reference and microbial tests are in class 10,000 cleanrooms; ISO13485 and CE 0029 standard is applied to all the production procedures. Sunny Medical – stand 3298 www.sunnymedical.com.cn

Contract catheter device manufacturing: Via Biomedical Via Biomedical provides custom catheter based devices to medical OEMs worldwide. Although Via is known for its expertise in custom compliant balloon development and manufacturing, it offers a whole lot more. Using its well equipped product development lab, including a comprehensive list of catheter manufacturing and test equipment, Via provides rapid prototype design and fabrication capability. In addition, it can move the initial design through product design verification and process validation into manufacturing. Whether you need a single prototype for concept evaluation or a complete product development and manufacturing program, Via’s highly experienced staff can help you reach your goals. Via Biomedical – stand 3294 www.viabiomedical.com

Contract medical development and manufacturing services: VitalDyne VitalDyne is a contract medical development and manufacturing service company. Capabilities include: catheter development, assembly of implantable devices (cardiac, drug delivery, neurostimulation and orthopedic devices). Micro wire fabrication includes ablation (.0005 in holes). Other services include stent cutting, micro holes and sterile packaging. The company is introducing Femto II cutting system for polymer and alloys. VitalDyne – stand 1853 www.vitaldyne.com

Contract device services: Web Industries Web Industries provides end-toend contract manufacturing and development services to medical device companies. It performs a full range of precision converting services for flexible materials, including slitting, spooling, winding, coating, laminating, die-cutting and printing. It also offers a wide array of value-added services, such as product assembly and packaging, specialty plastic film extrusion, electronic document control, and complete supply chain management. Web’s nationwide manufacturing locations are ISO 9001:2008 and ISO 14001 certified, and it has extensive capacity focused on the unique needs of the medical market, including medical cleanroom converting with ISO 13485 certification, GMP compliancy, and FDA registration. Web Industries – stand 1650 www.webindustries.com

Rapid plastic prototyping: Spectrum Plastics Group Spectrum Plastics Group excels at quickly turning engineering concepts into high quality models, with capabilities beginning with design support and rapid prototyping, all the way to full production moulding and contract manufacturing. Four physical plant locations operating as one cohesive and efficient business unit, Spectrum is a vital partner in product development, from quantities of 1 to 1,000,000. Capabilities include multi-cavity, LSR moulding, Quick-Turn rapid tooling and moulding, in-line inspection systems, automations, and cleanroom assembly. Its prototype capabilities include SLA, LS, Connex, cast urethanes, cast silicones, CNC, and blow moulding. We are ISO 9001:2008, 13485:2003 certified, ITAR registered. Spectrum Plastics Group – stand 1608 www.spectrumplasticshroup.com

Rapid prototyping: Star Prototype Star Prototype is a full service rapid prototyping company based in the Guangdong Province of China. Opened in 2005 by Gordon Styles, the former owner of UKbased Styles RPD, the company has created a niche for itself by offering Western quality at Chinese prices. The company has 90 people and has invested more than one million pounds over the last three years in the latest state-of-the-art technology so that it can rapidly turn around extremely accurate prototypes without compromising on the quality, which is essential for the medical sector. In addition to rapid prototyping, Star Prototype also offers rapid plastic injection moulding, rapid pressure die-casting, rapid precision machining and product inspection. Star Prototype – stand 645 www.star-prototype.com

Product design and development services: Ximedica Ximedica provides comprehensive product development services to the world’s leading medical device and healthcare companies. It assists clients in successfully getting userfocused medical products to market and developing innovative solutions that improve healthcare delivery. With a staff of experienced professionals, it integrates research, human factors and usability, engineering, regulatory, and introductory manufacturing services to ensure the highest quality outcomes. Ximedica has helped hundreds of companies launch devices for specialties such as: diabetes, endoscopy, laparoscopy, orthopedics, gynecology and urology. Ximedica is ISO 13485:2003 certified and FDA registered, with headquarters in Providence, Rhode Island and offices in Minnesota and Hong Kong. Ximedica – stand 1515 www.ximedica.com

MD&M PROFILES

Exhibitor Profiles | LOS ANGELES FOCUS

control. ZenPure is ISO 13485; 9001; 14001 certified.

Plasma treatment: PVA TePla America plasma systems and services PVA TePla America (founded as Branson/IPC in 1971) is a plasma surface modification systems manufacturer and service provider. It solves surface preparation problems for a broad spectrum of applications spanning precision cleaning, adhesion promotion, deposition of functional coatings and so on. It has the most diverse team of dedicated R&D scientists of any plasma treatment company worldwide. Its facilities in the United States and Germany have fully equipped laboratories and offer ‘free proof of process’ work to help industry researchers, designers and engineers develop customised surface chemistries for their materials. It is recognised for its quality engineering and manufacturing of a complete line of flexible, affordable, high performance radio frequency (RF), microwave (MW) and atmospheric gas plasma systems. PVA TePla America – stand 3330 www.pvateplaamerica.com

ZenPure – stand 1247 www.viabiomedical.com

Swiss mould making: Kebo Silicone component manufacturing: Specialty Silicone Fabricators Specialty Silicone Fabricators is a contract manufacturer of custom silicone components and thermoplastics. The company is an expert in all disciplines of silicone fabrication, including calendering, dip coating, extruding and moulding. Capabilities include flash-free moulding, precision extrusion and assistance with process qualification/validation. The company also provides innovative solutions for drug eluting combination products, assembly and packaging needs. Adherence to standards and rapid responses to requirements signifies our commitment to quality and performance. They are an ISO 13485 certified, FDA registered, and Japan Pharmaceutical Affairs Law compliant company. The company’s drug manufacturing license makes it a solutions provider.

Specialty Silicone Fabricators – stand 2008 www.ssfab.com

Filtration and purification product manufacturing: ZenPure ZenPure Corporation was founded in November 2002, specialising in the development and manufacturing of filtration and purification products and specialty membrane devices for a wide range of industries and applications. ZenPure strives for customer satisfaction and trust by providing reliable, unique, efficient and cost effective design, development and manufacturing services including OEM and private labeled products. ZenPure offers filters or membrane devices of any size, fitting type, and configuration based on all types of filtration media combinations. All products are manufactured in a class 10,000 cleanroom environment with full material traceability and quality 36/ MPN /FEBRUARY 2012

Medical Series Extrusion Tooling ISO 9001: Guill Guill utilises state-of-the-art 3D CAD, CFD and FEA software to design a broad spectrum of tooling. For high speed or high volume applications to ultra low volume that minimises polymer residence time in the extrusion chamber, Guill has a host of benefits to serve every special application. With Guill you select the best features and benefits to help optimise production as well as increase quality and precision. Guill – stand 1865 www.Guill.com

Swiss mould maker Kebo will use the MD&M as a platform to launch a new strategic move into the North American market. Andrew Sargisson (Sales Director) has been taken on specifically to promote the Kebo products to the medical sector in this region. The advantages of Kebo mould tools for the medical moulder include higher cavitation and shorter cycle times compared to current production, the secret to this is its in-house designed and built hot runner system including the amazing star gate nozzle. Kebo – stand 3026 www.kebo.com

Mould and tool making: Precision Tool and Die Precision specialises in product design that focuses on creating practical solutions, taking into account a client’s need for speed, efficiency and economics. The company offers services such as concept generation, design input, design planning, analytical study, and design refinement, 3D drawings, prototyping, cost estimating and design review. Plastic injection moulding, mould design, mould manufacturing, prototyping and short and long run, contact assembly and value added services for the medical device industry. All engineered and Class IV materials. Presses range from 28- to 400-ton. All products are offered at our one location. Precision Tool and Die – stand 1495 www.precisiontoolanddie.net

Mould and tool making: Precision Tool and Die

Contract medical moulding: Plas-Tech Engineering

Precision specialises in product design that focuses on creating practical solutions, taking into account a client’s need for speed, efficiency and economics. The company offers services such as concept generation, design input, design planning, analytical study, and design refinement, 3D drawings, prototyping, cost estimating and design review, plastic injection moulding, mould design, mould manufacturing, prototyping and short and long run, contact assembly and value added services for the medical device industry. All engineered and Class IV materials. Presses range from 28- to 400-ton. All products are offered at one location.

Plas-Tech Engineering, an industry leader in medical moulding, provides solutions to complex custom moulded plastic components which results in higher ROI. The company describes itself as “your source for medical device moulding solutions”. Services include multi-material moulding, overmoulding, multi-shot moulding, glass alternative materials, insert moulding, early involvement design services — design for manufacturing (DFM) and design for assembly (DFA) — complex material solutions, low-medium production volume, GMP and ISO 9001:2008 compliant, ISO Class VI (1,000) services, Class VIII (100,000) moulding, USP Class VI and FDA approved materials.

Precision Tool and Die – stand 1495 www.precisiontoolanddie.net

Plas-Tech Engineering – stand 404 www.plastechengineering.com

Exhibitor Profiles | LOS ANGELES FOCUS

Single use plastic devices: Xeridiem

MD&M PROFILES and welding technology. The company serves more than 500 customers and works with over 23 partners to distribute its products globally.

Contract Packaging: SteriPack expands operation to USA to support global demand

Xeridiem designs, develops and manufactures single use medical devices focused in gastroenterology, cardiology and urology, with an emphasis on design for manufacturability (DFM). In addition, the company offers full regulatory support including 510k submissions and CE registrations. For over 25 years, Xeridiem has enabled major medical device companies and venture-backed entrepreneurs to launch over 22 million medical devices used for patient care around the world. We offer a complete selection of services designed to bridge the gap from concept to commercialisation. In recognition of our design and development capabilities, in 2011 we were awarded the MDEA and R&D 100 awards.

SteriPack, a worldwide leading company providing cleanroom medical packaging solutions has recently acquired a new facility based in Lakeland, Florida, USA. Initially this 40,000 square foot facility will provide cleanroom medical packaging and contract manufacturing solutions and is expected to be operational by the end of summer 2012. The new facility in Lakeland along with existing SteriPack facilities in Europe and Asia allows SteriPack to better meet increased customer demand. SteriPack’s services also include pharmaceutical blister packaging, contract engineering and ISO 17025 accredited testing.

Xeridiem – stand 1949 www.xeridiem.com

SteriPack – stand 1421 www.steripackgroup.com

Vante – stand 2501 www.vante.com

End of Line equipment for catheters and bio-pharma: Vante Vante is an employee-owned, global technology company that designs and produces products for the precise manipulation of medical plastics. It is focused on catheter manufacturing and development, bio-pharmaceutical products, and related engineering services. Vante has been a leader in the industry for over 30 years. Specialising in the four categories of catheter manufacturing equipment, biopharmaceutical equipment, industrial applications and OEM solutions, Vante's products include their own manufacturing systems, industrial tube sealers, and plastic sealing

End of line: Syneo Syneo is formed by the merger of ASG Medical Systems, the leader in catheter and guidewire manufacturing automation and Technical Innovations, the leader in hole drilling and hole punching technology for catheters and cutting tools for surgical cutting applications. Syneo is the medical device solutions partner for the cutting, feeding, slitting, flaring, grinding, skiving, printing, punching, assembly and drilling of catheters and guidewires. Syneo – stand 1601 www.syneo.co

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DOCTOR’S NOTE

KTNs hold clinicians workshop to share knowledge

(Above )“WoundSense™ moisture sensor and meter by Ohmedics Ltd. Photograph supplied by Professor Patricia Connolly, Bioengineering, University of Strathclyde” (Left) Mehdi Tavakoli

Knowledge Transfer Networks (KTNs) are to hold a workshop for clinicians to share knowledge and to stimulate innovation in communities at The Mermaid Conference Centre in London.

ealthTech and Medicines Knowledge Transfer Networks (KTNs), in collaboration with The workshop called ‘Clinical the Electronics, Needs and Sensing Solutions’ will Sensors, Photonics take place on March 6, and is KTN mapping of unmet clinical currently taking registrations. needs, involving clinicians in research and collaborative R&D with healthcare and the medical industry will be discussed along with the efforts and the strategic objectives set out by the two KTNs. The workshop is open to all those who work within medical devices, particularly sensors and in a clinical environment, those who specialise in orthopaedic, paediatrics, emergency medicine and urology, including academics and companies who provide healthcare products and solutions and funding organisations who wish to look at new developments within the industry. Ideal attendees should be companies seeking to 38/ MPN /FEBRUARY 2012

exploit their sensing technologies in new medical areas, individuals or companies who wish to identify leading clinicians to establish long term collaborations as well as large medical device and diagnostics companies interested in directly sponsoring innovative ideas, working closely with clinicians, academics and SMEs. Clinicians active in research and development as well as those who actively identify solutions in medical technology should also attend. The event aims to facilitate new clinician and industry collaborations, to identify barriers to innovation and commercialisation, review current funding opportunities, provide networking opportunities, review current pre-clinical and clinical trials along with identifying the best practice to accelerate regulatory approvals. There will also be opportunity to review supporting mechanisms available to accelerate innovation and commercialisation through the KTNs. Professor Mehdi Tavakoli, technical director of Health and Medicines KTN who has designed the main agenda for this event and invited the clinicians said, “To ensure that innovations in healthcare lead to successful clinical outcome and commercialisation it is critical to involve clinicians at the early stages of development. “Facilitating clinicians and healthcare industry collaborations by identifying unmet clinical needs, forming successful partnerships and securing funding opportunities can play a major role in accelerating innovations leading to commercialisation and, finally, benefits to patients. The clinical specialities due to be covered during the workshop are orthopaedics and trauma, emergency medicine, paediatrics and urology. Professor Simon Donell, Consultant orthopaedic surgeon at Norfolk and Norwich University Hospital (NNUH) and Honorary Professor University of East Anglia, will be among the speakers scheduled throughout the day, who will talk about sensing relating to fractures, muscle damage, joint replacement and wound infection. For more information on the workshop, see a schedule of speakers or to register for attendance visit www.innovateuk.org/healthktn.

WORDS | GARETH PICKERING

Swiss Finishing: Check Out the Vital Signs PRECISION, INGENUITY, COMMITMENT AND PASSION — THE ETHOS OF SWISS MEDICAL PLASTICS MANUFACTURING.

Introduction Representing Medical Plastics News, Gareth Pickering visited Switzerland to find out about its leading medical plastic suppliers. Switzerland plays a vital role in European medical device manufacturing. Born out of the precision of the watchmaking industry, medical device manufacturing was a natural extension to this. Thanks to a combination of precision, accuracy and ingenuity, the

40/ MPN /FEBRUARY 2012

Swiss can boast a high density of medical technology companies. Indeed, 1,400 are active in the 15,940 sq miles of land which Switzerland occupies. At the national level the sector is supported by a proactive government programme and a plethora of hands-on industry bodies such as Medtech Switzerland, Medical Cluster, Swiss Exchange and the Swiss Life Science and Marketing Alliance. The vital signs are healthy; the

medical technology industry grew by 12% in 2011, well above the forecasted rates for the life sciences industry. The Swiss Medical Technology report (2011) puts the net sales for the sector at CHF 11.1 billion (US$12 billion), with 85% of this turnover coming from medical devices. The sector accounts for 49,000 employees — or 1.4% of the total Swiss work force — and total gross revenue exceeds CHF22.9 billion. An undoubted success story.

That said, the industry faces the same rea concerns as every other around the world. Basel A Familiar challenges include the strength of the Swiss Franc. Recent Swiss central bank interventions to purchase Euros to guarantee a parity of a minimum ratio of 1.2, reassured some, but with the country exporting 80% of its medical devices Berne Capital to its Euro zone neighbours, the uncerArea tainty over the European project is palpable. However, the Swiss economy is fundamentally strong. Banks are lending; contrary to what may be the case in other independent currency BioAlps countries within the EU, and investment confidence is high. There is also a small but committed band of business angels and venture capitalist groups committed to life sciences and the medical sector, allowing research and development to flourish. The standard rate tax (7.6%) along with the fact that Switzerland has these companies, although the Berne the lowest VAT burden in Europe makes Capital and Zürich areas also claim Switzerland the most favourable tax significant representation. From the world regime in Europe. leading designers and prototypers to All parts of the manufacturing supply mould makers and injection moulders, chain can be found throughout Switzerland has an enviable collection of Switzerland. The Schaffhausen region, leading companies. In medical plastics, nestled in the North West, boasts many of Switzerland’s tool makers are among the

SWISS FOCUS Greater Zurich Area

Biopoolo Ticin most famously precise in the world, and their strong ties and family-like relationships with nearby contract manufactures gives the country a real edge in device manufacturing. The trade show, Swiss Plastics in Lucerne, has a strong medical content, all nestled on the edge of the Swiss alps — pure bliss!

FEBRUARY 2012/ MPN /41

SWISS FOCUS

Introduction from Medtech Switzerland Medical technology in Switzerland has a great heritage as well as a promising future. The sector’s success is driven by a culture of innovation and quality which is in part due to a history of precision manufacturing originating from the watchmaking industry. Currently Switzerland’s relative medtech share of the GDP and workforce is among the highest in the world and represents business activities across every step of the value chain. The country provides economic, political and social stability as well as a reliable infrastructure and excellent quality of life. With the economic downturn, medtech companies across the globe have encountered economic challenges which frequently translate into funding cuts in innovative technologies and R&D. Due in part to the strong collaboration approach amongst medtech players in Switzerland and a commitment from the government to support the industry, the Swiss medtech sector continues to maintain a position of strength through a focus on innovation. As we continue to navigate the ever-changing global medtech market, the Swiss commitment to quality, innovation, and technology know-how will help fuel the future success and growth of the medtech industry as a whole.

Dr. Patrick Dümmler Managing Director, Medtech Switzerland

Riwisa — expert in design, development and injection moulding

RIGHT: The multi-component plastic based dry powder inhaler is one of Riwisa’s ground breaking design and manufacturing projects.

Riwisa AG Kunststoffwerke Our first visit took us to RIWISA AG, headquartered at Hägglingen in the canton Aargau. Going under the principle “Plastics in Perfection” for more than 65 years the company is a well-known specialist for product development, engineering, injection moulding, assembly and additional services such as welding, CNC-milling and more operations. Based on this performance spectrum, today Riwisa serves the industry, consumer and medical markets as a contract manufacturer with tailor-made solutions for its customers. The state-of-the-art cleanroom plant (approx. 3,800 sqm) with fully automated infrastructure illustrates a perfect insight of the entire medical device manufacturing supply chain, starting from raw material up FEBRUARY 2012/ MPN /43

injection moulding | CLEAN MACHINES

continued from page 43 to the assembled and bagged product under controlled cleanroom conditions. Working in close cooperation with its customers RIWISA provides product design and development, prototyping, moulding, assembly, welding and packaging services. With its long term expertise RIWISA assists in moulding tasks like insert-, multi-component-,

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in-mould-labeling- coinjection- and micro injection moulding. The portfolio of performed products covers solutions for diagnostics, disposables and primary packaging devices for dental technology, ophthmalic systems as well as resorbable implants and devices for the pharmaceutical industry. One example, which best demonstrates Riwisa’s expertise to handle complex projects from first idea to full

scale manufacturing is the Dry Powder Inhaler (DPI). Within this DPI project, RIWISA made a future-oriented step into the medical market many years ago. Starting this ambitious project it had to implement medical specific process requirements beginning with the development of a complete new device. In a next step the associated cleanroom manufacturing and assembling processes were implemented, finally the device underwent the release by the international authorities FDA and EMA. To set up the right environment for manufacturing of these high quality products RIWISA invested in a state-ofthe-art cleanroom plant, fully equipped with permanent monitoring systems and an automated cleanroom storage system. The assembling of the plastic made DPI relies on a high degree of automation. The cleanroom conform robotic systems allow cavity separation of all moulded parts. In addition the automated assembling process of the 21 single parts implements the high autonomy of the line. More than 100 inline control stations, the in-process and release testing and the computerised traceability guarantee a high quality standard of the final product. Developing this device RIWISA gained extensive experience in the field of medical regulation. Today an in-house department with experts in Regulatory Affairs ensures the knowledge necessary for the concurrent needs in regulatory requirements and documentation. According to Christian Classen, Business Development Manager Medical: “As a RIWISA-customer you benefit far more than from a production company: our expertise ranges from product design and development engineering throughout project management, quality assurance and regulatory affairs to series manufacturing of the products developed. This is what we mean by — from engineering to the final product — from one source.”

SWISS FOCUS

KEBO —

Seriously Swiss Mould Manufacturing At 7.30 am the KEBO AG offices in Neuhausen are in full swing. Industry meets ingenuity here. KEBO is a mould makers and injection moulding specialists responsible for developing highperformance injection moulds which are used for the production of some of the most advanced medical, laboratory, pharmaceutical products, as well as closures and packaging. Some of which are featured in this article. However, it’s KEBO’s understanding of the moulding process and particularly the hot runner technology that sets it apart. Having designed its own hot runners and various types of full hot runner gating systems, KEBO’s technicians carry out thermal and rheological calculations to

ensure optimal filling of the part during the injection moulding process. Providing moulding technology to the medical, laboratory and pharmaceutical markets is a demanding business; parts need to be produced with maximum efficiency, there are narrow precision tolerances not to mention the need to be durable with minimum maintenance. Cost control is critical and an optimally designed mould helps to achieve this. KEBO has recently developed a mould that reduces costs by up to 40% in comparison with the original design by eliminating the two submarine gate points and fitting a full hot runner heated tip (see figure 1).

FIGURE 1: KEBO has developed a mould that reduces costs by up to 40% by eliminating the two submarine gate points and fitting a full hot runner heated tip.

FEBRUARY 2012/ MPN /45

SWISS FOCUS The fitment of the full hot runner injection system means that the parts are injected by means of a lateral gating system, which results in better process control and higher productivity. Due to the elimination of the sprue and runner the cycle time can be significantly reduced, thus direct savings are achieved. The advantage of the full hot runner system as opposed to the part hot runner system is estimated to make up to 40% savings on the injection moulded part cost (see figure 2). Kebo will be exhibiting at MD&M West in Anaheim, California in February (see page 36) as well Medtec Europe in Stuttgart in March (see page 21).

FIGURE 2:

Degradable Solutions — leading the way in bone graft substitutes and resorbable biomaterials Another Swiss success story is Degradable Solutions (DS) who are leading the field in resorbable polymers and calcium phosphates for tissue fixation and bone graft substitutes. Emerging from a spin-off of the Technical University of Zurich (ETH), DS are leading the way in coating technologies. The tiny granules are essentially a resorbable calcium phosphate which has been coated with a micro thin layer of polylactic acid allowing for the malleableglue like properties of the substance to fill the cavity or bone defect perfectly. By adding a Biolinker — an activator liquid which transforms the coated granules into sticky mass — the bone graft substitute can be applied directly through a syringe. The ingenuity of the DS trademarked easy-graft means, when in contact with blood, the biomaterial solidifies and forms a 46/ MPN /FEBRUARY 2012

defect-analogue, mechanically stable mass which is porous and will be replaced by bone tissue over time. DS Degradable was the recipient of the Swiss Technology Award back in 2004 and have added to the portfolio of resorbable technologies by developing drug release coatings, colourings for enhanced intra op visibility and resorbable x-ray markers for complete post op control. They are a great example of Swiss ingenuity. CEO Kurt Ruffieux said, “Coating the surface of TCP granules enabled us to create a unrivaled handling of our bone graft substitute and gave us a decisive advantage over our competitors. The

Clockwise from top left: (1) Easy-graft granule: Cross-sectional part-view through a single easy-graft granule showing the continuous coating on the porous b-TCP granule. (2) Easy-graft syringe: easy-graft, a synthetic bone graft substitute forming a mouldable paste that hardens to a porous body in-situ. (3) Sysorb: Sysorb, patented turbine-shaped screw head of bioresorbable interference screw for reconstruction of the crucial ligament.

product easy-graft is the only bone graft substitute on the market forming a mouldable paste that hardens to a porous body in-situ.”

Gsell Medical Plastics AG: Established manufacturer of medtech products We are your manufacturing partner of choice for medical implants and medical devices manufactured from high-end polymers such as PEEK and PE as well as carbon-fibre-reinforced compounds. Company Gsell Medical Plastics, since its foundation in 1984 by Rene Gsell, has enjoyed considerable success in the European medical devices market. Among our many milestones, we put a state-of-the-art air-conditioned production facility into operation in 2009. Gsell Medical Plastics focuses on small series and niche products, developed and built to specific customer requirements. We are constantly on the lookout for new challenges in plastics production processes â&#x20AC;&#x201C; to succeed where others give up or fail.

Medical tubing products Our core business comprises mechanical or thermal deformation techniques, laser marking and (laser marking, overmold and medical tempering.). If required, we will produce under clean room conditions. CFK made by Gsell Our CFK products are lightweight, radio lucent and sterilisable, and they meet very strict dimensional accuracy and stability requirements. Our production know-how and a tight quality management ensure excellence all along the manufacturing process.

Products Whether components, products or entire systems: Gsell Medical Plastics produces exclusively on behalf of its customers. Our products and services range from materials management to sterilisation and packaging.

Implants Our validated production processes and our machinery are strongly focused on plastics. Top-quality articulation surfaces for knee, hip, finger or shoulder implants are our principal business, PE and PEEK are our main materials. Our customers benefit daily from our more than 20 years of experience and know-how in this field. Gsell Medical Plastics AG Pilatusstrasse 32 CH-5630 Muri AG

Injection molding We are experts in injection molding, from granules to implants or semifinished blanks. In close cooperation with you, we solve any molding problem â&#x20AC;&#x201C; material, lot size, feasibility. Our equipment is optimized for PEEK and PEEK CF polymers. Quality Gsell Medical Plastics is ISO 9001 / ISO 13485 certified.

P: +41 56 675 40 40 F: +41 56 675 40 49 W: http://www.gsell.ch/en.html

SWISS FOCUS

GSELL Medical Plastics — Over ten thousand implants for knee, hip, shoulder and spine every year

Medisize — injection blow moulding for ingenious bottle and overcap system Production plants are big business in Switzerland and the availability of high calibre school leavers and university graduates who are keen to pursue a good career in the manufacturing sector means that Switzerland is a leading country of choice for pan European organisations that are looking for high quality high production locations. Medisize is one such example. The recent acquisition by the USA-based medical plastics giant Philips has strengthened the ubiquitous Medisize brand. From its Nürensdorf plant (boasting 500 square metres of class 7 and class 8, cleanroom facility) Medisize provides leading solutions for the healthcare market. Its primary pharmaceutical packaging expertise includes development and production of a wide selection of bottles, dosing systems and closures using a wide range of materials. Medisize’s injection blow moulding machines and cleanroom facilities are state of the art and with more than 30 years’ experience the company has become one of the market leaders for primary pharmaceutical packaging. Over the years, ideas, creativity and smarter solutions have led Medisize to work on ingenious pharma packaging projects. Dual chamber mixing devices, dispensing and dosing systems and closures as well as tablet dispensers count towards the products made daily at their plant in Switzerland. Pushing injection blow moulding technology to its limits, Medisize has developed a safe bottle and overcap system specifically for the healthcare market. The overcap can be transformed by colour by dying or by being made transparent — making it visually impressive (for more on colour in medical plastics see Design 4 Life on page 24). The new injection blow moulded bottle supersedes the former extrusion blow bottle as both the quality and dimensional accuracy is significantly increased, combining a perfect fit of the overcap with improved ease of opening. 48/ MPN /FEBRUARY 2012

Medisize’s new bottle system is based on the idea of an extended hygienic standard. The area where liquid flows out remains uncontaminated as the bigger overcap covers the pump completely, thus the solution remains clean and protected from external influences like pollution or due to an application error.

Safety is paramount and improved functionality has eliminated the possibility of an accidental press of the pump by the clever design of the cap as it protects the whole upper part of the bottle and pump. The new bottle system is based on the idea of an extended hygienic standard. The area where liquid flows out remains uncontaminated as the bigger overcap covers the pump completely, thus the solution remains clean and protected from external influences like pollution or due to an application error. Custom sizes and designs (oval and square) can be developed and produced in short lead times. The new closure technology offers advantages including simplistic packaging and safe operation while ensuring highest hygiene protection. In other initiatives Medisize has developed a complete range of PET bottles with a PP28-neck for pharmaceutical use. These bottles are produced by injection stretch blow moulding. The one piece screw cap enables Medisize to propose a complete tamper evident primary package to its customers.

GSELL Medical Plastics produces high quality plastic components for the medical technology sector and supplies customers worldwide with over ten thousand implants for knee, hip, shoulder, spine and more every year. Carbon reinforced medical equipment like targeting devices or medical tubings like catheters are also in its portfolio, as well as implantable injection moulded PEEK products including post machining where required. GSELL Medical Plastics develops process and cost-optimised solutions and supports customers throughout the development process, from material selection to production processes and from prototype to series production. The company maintains deadlines, holds cost under control and provides high quality at all times. For its customers this means Swiss Quality at a fair price-performance ratio. Summary The common theme running throughout the Swiss medical device industry is the passion for producing world leading solutions, devices and ideas. Swissness is not a commonly recognised noun, although interestingly it was used, unprompted, by many of the companies we spoke to. It says it all. Precision, ingenuity, commitment and above all passion. These are the values that run deep in the ethos of Swiss medtech companies. All this, and in your choice of at least four different languages, they’re a clever bunch! As we go to press the industry is supported by the Swiss Plastics (Schweizer Kunststoffmesse) exhibition which takes place in Lucerne. In 2008 the Swiss Plastics exhibition attracted more than 3795 visitors and 188 exhibitors. Watch out for the Swiss Medical Technology event at the Palexpo Geneve ( June 5-8) 2012. This event will see the 2nd Medtech exhibition and is a key event in the calendar. For more information see http://www.epmt.ch/fr/smt/.

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PIP silicone breast implants

could have been missed by MHRA

Recent UK headline news has been filled with the story of the non medical grade PIP silicone breast implants that has caused thousands of women around Europe to panic over the safety of the materials used in the implants. But perhaps the questions that should be asked over this story is how these implants were allowed to be used on the UK market, given the strict rules that the Medicines and Healthcare products Regulatory Agency (MHRA) applies to all medical devices.

WORDS | LAUREN MYATT

PIP,

or Poly Implant Prosthese implants, were made by a French company of the same name, which allegedly blamed the MHRA for not carrying out the correct checks to ensure that the implants were safe for use. The fact that the silicone used in the implants was industrial rather than medical grade has caused panic for thousands of women said to have had the implants over Europe. It is thought that around 40,000 women in the UK alone have had the PIP implants, with around 95 per cent

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of them being provided on a private basis. But despite the UK government claiming that women should not necessarily have the implants removed, the NHS has announced that it will replace the implants for those women who are concerned. Many private clinics are under pressure however, following a recent march by around 60 women in London, after they claimed that they could not afford to replace the implants on a private basis and some of the clinics were unable to replace them due to the costs involved. These private clinics are now blaming poor regulations by the MHRA and are concerned as to why these implants were sold in the UK market. Medical Plastics News spoke to Len Czuba, president of Czuba Enterprises Inc. former president of the SPEâ&#x20AC;&#x2122;s Medical Polymers Division and someone who has served as an expert witness in many product liability cases. He said, â&#x20AC;&#x153;As frightening as this situation may seem, realistically I believe that it is not a big problem. â&#x20AC;&#x153;How they got into the market is a topic that needs some investigation and if this company by-passed or ignored the regulations, then the principles in the

MATERIALS company should be held legally liable. My experience is that the company was either not aware of the regulations or thought that they were in compliance and were acting under incorrect interpretation of the rules. “Regulatory agencies have a hard time keeping up with the flow of products entering the marketplace and situations like this are not that uncommon. “However it is more surprising that it is with long term implants such as these breast implants that is more a concern. But it just points to the fact that often the users rely on the representatives of the company that may tell them that the new products are safe and ready for use when in fact they may not be. “I don’t know many end users that will go and check the regulatory status of a new product; rather they would assume that the company has met all the requirements before they would attempt to sell the product for use.” The British Association of Aesthetic Plasitcs Surgeons (BAAPS) recently issued clear guidelines for doctors and patients regarding the PIP implants. The document, Poly Implant Prostheses (PIP) Breast Implants: Joint surgical statement on Clinical Guidance for Patients, GPs and Surgeons has been jointly endorsed by the Association of Breast Surgery, the British Association of Plastic, Reconstructive and Aesthetic Surgeons, the British Association of Aesthetic Plastic Surgeons, the Federation of Surgical Speciality Associations and the Royal College of Surgeons. Consultant Plastic Surgeon Tim Goodacre, head of professional standards at the British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS) said, “It has been a distressing time for all the women caught up in the PIP breast implant issue. “We must now look at how cosmetic products and interventions are regulated in the UK more broadly so that we can avoid a repeat of this scenario. BAPRAS continues to be driven by patient safety and professional standards. Consultant plastic surgeon and BAAPS President Fazel Fatah, said, “We are delighted to jointly provide clear surgical guidance that removes any ambiguity about the right course of action, not just for women who have PIP breast implants, but to all those who become involved in their care and treatment — including GPs and surgeons. “Our message also reinforces the importance of commitment to duty of care for anyone providing private health services to the public. The BAAPS remains steadfast in our recommendation for precautionary removal of these defective implants.”

comment: Believing that American servicemen favoured women with big breasts, Japanese prostitutes injected their breasts with paraffin and non medical grade silicone throughout Steve Wheeler the Second World War. managing director of Not surprisingly the practice didn’t really Primasil Silicones take off! Well, not until the swinging Limited sixties, which saw the introduction of silicone breast implants. Also around this time the Food & Drug Administration (FDA) was founded in the US to review the safety of all new medical devices. Of course, the breast implants were a newsworthy topic and they soon became the subject of public interest. Coupled with the growing acceptance of corporate lawsuits the legal cases soon followed. The first was filed in 1977 and by the end of the last century more than 20,000 lawsuits had been filed against Dow Corning, who filed for Chapter 11 bankruptcy protection which lasted nine years. The company stopped supplying implants and has since become a corporate giant with turnover in excess of $5 bn and over 10,000 employees. That Dow Corning stopped supply of silicone implants represents the power of the media vis-a-vis scientific research. In 1992 a panel concluded that no causal link had been established between autoimmune disease and silicone breast implants. Moreover, by December 1995 more than 20 studies had failed to support a causal relationship between silicone implants and a variety of illnesses. Indeed the Institute of Medicine in the US concluded that “Some women with breast implants are indeed very ill and the committee is very sympathetic to their distress... However, it can find no evidence that these women are ill because of their implants.” So what of the current situation with the former implant supplier, PIP? Well, moving away from sensationalist stories it is apparent that the problem is not so much about the grade of silicone per se, but the manufacturing process that could result in the rupture of the implant. This causes silicone to leave the implant and travel around the body. That is, it is not so much a material issue as a manufacturing issue. It is clear to an observer that corners were cut and non approved silicone was used in this instance, but it should be pointed out that silicone is inherently non toxic. Bio compatibility with the human body should not be an issue with silicone rubber. When the appropriate grade of material is used it is ideal for baby bottle teats, catheters and many other commonplace medical products. Notwithstanding its non toxicity, silicone rubber has outstanding physical and environmental properties which make it the material of choice for applications across all industries. Primasil Silicones provides customised silicone rubber compounds to exactly meet the demands of the product. The company also provides liquid silicone injection moulding and extrusion services in an ISO7 certified cleanroom to ISO13485 standards. www.primasil.com FEBRUARY 2012/ MPN /51

Bluestar Silicones Delivers Custom Silicone Solutions

for Antimicrobial Applications Bluestar Silicones has launched a customised approach to the manufacture of antimicrobial silicone products that offers processors tailored material solutions to meet specific healthcare application needs. Unlike competitive offerings that are “one size fits all,” the company claims it is able to fine-tune its products and deliver materials that precisely fit the application without sacrificing performance. “This material development initiative is strategic to our healthcare business,” said Karen O’Keefe, North American healthcare market manager. “We’ve collaborated with our customers and

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on silicone materials. This body of knowledge enables the company to provide tailor-made antimicrobial products without a sacrifice in performance. made a significant investment in acquiring the experience and expertise to fill the unmet needs of the healthcare market.” Medical device makers are seeking new material solutions to inhibit bacterial growth and combat the increase in cases of hospital-borne infections. During a two-year research and development project, Bluestar Silicones examined a wide range of antimicrobial additives, both organic and inorganic, and assessed their impact

“We are not limited to one type of material; we have a broad material tool box,” said Dr. Olga Hoy, PhD, senior scientist for Bluestar Silicones. “Based on a customer’s needs, we can anticipate in advance and develop a customized formulation.” The company said that by closely matching the antimicrobial additive with the silicone, core properties could be maintained while antimicrobial protection is added.

MATERIALS New silicone rubber tourniquet that significantly reduces infection Non-reactivity with bodily fluids and skin is a given when selecting a material for any medical device in contact with humans. Durability, long-life and strength may play second fiddle to the biocompatibility hurdle but more and more medical device manufacturers are realising that silicone rubber ticks all these boxes. Gaining momentum across all industries since the 1950s, silicone rubber is fast becoming the default material of choice for medical device manufacturers. With the following key strengths, it’s easy to see why as silicone rubber is biocompatible and non toxic because it can withstand common sterilisation methods, it has an operating temperature range of -50ºC to +250ºC, it can be supplied in hardnesses ranging from 10 to 90 Shore A, it can be pigmented to virtually any colour and is flame retardant. The rapid growth of silicone rubber is a reflection of these outstanding physical properties, coupled with the need to substitute unsuitable materials such as latex, plastics and fabrics. Caroline Herdman, medical division manager at Primasil Silicones in the UK agrees, she said, “A large proportion of our new work is directly replacing materials used for existing products. Such is the ease with which our lab can pigment silicone rubber compounds our customers have no problem getting the silicone rubber upgrade through their marketing department. The device looks just the same but with vastly improved properties.” It’s not only material substitution though. Dr Iain Varley had the vision to see how a silicone rubber product could reduce the prevalence of Hospital Acquired Infections (HAI). Widely recognised as a significant problem in modern healthcare, Dr Varley understood that good infection control procedures could help reduce the burden of HAIs. He said, “The tourniquet is the last barrier to infection control, and almost half of tourniquets in use are visibly contaminated with blood. The hepatitis B virus remains infective for 1 week in blood spilt on a tourniquet and the same tourniquet may be used on multiple wards and patients, regardless of infective status. Even replacing tourniquets daily fails to prevent them from being contaminated with MRSA.” Utilising his extensive phlebotomy experience Dr Varley designed a new silicone rubber tourniquet that significantly reduces infection. Called the ‘SAINT’ this new tourniquet addresses the shortcomings of the disposable tourniquets which are often difficult to use and uncomfortable for patients. This new tourniquet is easy to secure and and easy to release, exceptionally comfortable for patients due to a specially formulated silicone, 100 per cent free from latex, FDA compliant, USP Class VI conforming and conforms to 93/42/EEC as Class I Medical Device Single-use only. www.primasil.com

Automotive culture for medical device manufacturing It is generally understood that automotive component manufacturers have developed massively during the last decade with the result being a culture of high quality, low cost, short term engineering project cycles and a global manufacturing with an effective just in time logistic. Most of those key issues are being increasingly demanded by the medical sector according to Gonzalo Martin from Cikautxo, silicone technology experts based in the north of Spain. From this point of view, a European based company with a ‘contract manufacturing’ business model operating both in the automotive and medical sectors might be of high interest for the OEMs wishing to have a European reliable, competitive and global contract manufacturing partner. An example in the field of the silicone components for medical applications is Cikautxo, a Basque company with expertise in the field of silicone technology valid for both automotive and medical components. The engineering is made by the same designers, the rapid prototyping is common, the mould manufacturing is the same because liquid silicone is used in many automotive applications, and only the raw material and the manufacturing environment are different; in one case the silicon has to have a medical degree appropriated to the medical device class (I, IIa, IIb or III) and in the second aspect the manufacturing has to be performed according to the appropriate cleanroom manufacturing practices. Apart from these two particular differences, the quality and reliability culture, the low cost design and manufacturing expertise, the rapid design and prototyping mean that the medical industry is now or will be just as competitive as the automotive sector. www.cikautxo.com

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END OF LINE

A Fair Hearing

Leister’s Mask Welding Technique Used for Wipe Clean Hearing Aids The innovation in question is the new cerumen (ear wax) protector SmartGuard. It uses a 15 μm thick polymer diaphragm to protect the In our Laser Welding sound outlet, focus we look at how without having Leister’s patented high any significant precision welding deleterious process has enabled effect on the acoustic Phonak, the Swiss properties. hearing aid giant, to The develop a technology diaphragm is that protects hearing mounted on a aids from ear wax. thermoplastic carrier ring. The strength of the connection to the carrier ring is high, despite the small area of the joint. Any deposits on the diaphragm can be removed by regular wiping with a soft cloth. Mask welding The mask welding process — developed and patented by the Swiss

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laser system manufacturer Leister Process Technologies and operating on the principle of laser transmission welding — is used for joining the diaphragm to the carrier ring. This involves connecting a joining partner that is transparent to laser radiation with an absorbing joining partner. In the case of the cerumen protection, the diaphragm is transparent to laser radiation. The carrier ring, on the other hand, is made from a thermoplastic material which has a fixed shape. It is black in colour and thus absorbs the laser radiation. In the mask welding process used here, a copper or chrome covered glass mask is inserted between the laser source (diode laser) and the component. A linear, well collimated — in other words, parallel — laser beam is moved over the parts to be joined. The laser radiation only impinges on the parts to be joined that are not blocked off by the mask. The use of the mask makes it possible to illustrate the finest

of structures. This means that mask welding can achieve high levels of precision. This welding concept allows fulfilling a further requirement, namely the need to keep the area for welding to a minimum. This means that there is more area available for the acoustically active diaphragm surface. It is only with the mask welding process that the necessary strength can be achieved with the smallest of welding areas. Modern hearing aids rely on precision laser welding of miniature plastic component parts.

Mechanical engineering students set to benefit from new LPKF agreement

echanical engineering students at Regensburg University in Germany will gain practical experience thanks to a new cooperation agreement from the laser welding division of LPKF Laser and Electronics AG. A bit of practical work is an essential part of studying an engineering subject and with this agreement now firmly in place, around 40 students are set to benefit initially. The specifications are ambitious with groups of two to three participants given an identical task to develop and evaluate clamping methods for the robot-assisted TwinWeld welding technique. The narrow terms of reference provide a realistic production framework for the task. All the groups are to develop solutions following two different basic approaches, and then present the results — the winners will be rewarded with a cash prize. The first step in this process has already been undertaken with the students taking part in a factory tour of the LPKF office in Erlangen, accompanied by their professors Dr Ing. Stefan Hierl and Dr Ing. Thomas Schaeffer. LPKF is delighted to be able to cooperate with the university, as Frank Brunnecker, the current branch manager explains, “We highlight the fact that a job in the engineering profession is regularly associated with exciting challenges. “At the same time, we are raising our profile at the university with the aim of attracting students to apply to us for employment when they have finished their degrees — as an active part of our endeavors to recruit qualified technical staff”. www.lpkf.com

FEBRUARY 2012/ MPN /55

END OF LINE Miyachi Europe Unveils ML-5060A Laser Welder High Efficiency Direct-Diode Laser Ideal for Welding Plastics and Soldering

Miyachi Europe, the leading supplier of laser and resistance welding systems and laser marking products, announces the availability of its new ML-5060A laser welder, the reportedly perfect solution for plastic welding and soldering applications. The new ML-5060A is a high efficiency direct diode laser that does not require YAG or YVO4 rods, resulting in low energy consumption and maintenance costs. Offered with a two-year warrantee on the laser diode that lowers the total cost of ownership, the ML-5060A also has a small footprint that minimises required manufacturing floor space.

The ML-5060A’s maximum power is 65 watts and its minimum spot diameter is φ0.6 millimetres. An air-cooling system simplifies equipment set-up, and no water cooling is required. A unique power feedback feature ensures high stability of laser outputs. The fibre beam delivery features easy integration, and optional dual outputs with power sharing facilitate optimal laser deployment. The ML-5060A is certified to Europe’s IEC/EN60825 standards. For more details, please visit Miyachi’s website at http://www.miyachieurope.com/ products/laser-welder/miyachi-highpower-direct-laser-welder/.

Paul Brindley, Regional UK Sales Manager: << Its high power and continuous wave with a large spot size and its wave length of 915 nm make the new direct diode laser welder ML-5060A a perfect solution for soldering applications and welding plastics. Furthermore, low energy consumption, low maintenance cost and a 2-year warranty on the laser diode ensure a low cost of ownership.>>

Ultrasonic cutting helps reduce urinary tract infection (UTI) rate

It has been suggested that urinary catheters which have smoother drainage apertures reduce the incidence of urinary tract infections. An ultrasonic cutting technology has been developed that gives smooth apertures and eliminates problems associated with debris.

Importance of high quality manufactured catheters A particular cause for concern is the texture and shape of the apertures that are formed within the catheter wall. Because these apertures are required to allow drainage of urinary fluids, they must be perfectly smooth and free from burrs. Traditional mechanical cutting or piercing/puncturing the catheter body is not reliable in producing smooth apertures or removing debris thereby encouraging bacterial growth and therefore infection. An ultrasonic processing solution Using ultrasonic processing technology, specialised tooling has been developed that can be used to cut and form a smooth aperture through a catheter body. Solid titanium tooling, or sonotrodes,

are connected to thruster-booster coupling which is designed to vibrate the tip longitudinally from 15,000 to 40,000 Hz. The high vibrational forces which are developed allow the sonotrodes to precisely and efficiently cut through polymeric surfaces leaving a smooth finish and no debris. The new cutting technique combines a vacuum drawing system within the ultrasonic cutting tool so that when an aperture is cut, the vacuum simultaneously removes the chad and conveys it to an electronic counter. If a chad is not counted for each aperture that is cut, then the manufacturing process is automatically stopped and can only be restarted when the faulty catheter is physically removed and disposed off, which ensures 100% elimination of a problem with missing chads.

References available upon request from the editor.

By A.L. Profit, Rainbow Medical Engineering Ltd, Letchworth Garden City, UK and Professor Gino Martini, Chair in Pharmaceutical Innovation, Kingâ&#x20AC;&#x2122;s College London

FEBRUARY 2012/ MPN /57

Class I medical device Stethescope

WORDS | LAUREN MYATT

A Class of their own:

clearing the confusion over medical device classification

58/ MPN /FEBRUARY 2012

REGULATION REVIEW

Class I

edical device manufacturers need to follow the Medical Device Directive (MDD) rules to ensure that their products meet the required standards to allow the product to be put onto the market.

However, the MDD has many complex Annexes and essential requirements that can often cause confusion. Over the next five issues of Medical Plastics News, medical device class will be explained to give medical device manufacturers the confidence when choosing the correct class for their products. In this issue we will look at each class and also explain this in relation to surgically invasive devices, longterm medical devices and long-term implantable devices. We will also look at how a medical device manufacturer can place their product on the market. The MDD defines a medical device as ‘any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings’. This definition covers all medical devices, including contraceptive devices, which come into contact with the human body. Currently the MDD is made up from 12 annexes, with each annex covering a range of essential requirements, which have to be met by the manufacturer before the product can be released to the market. It also outlines the four main classes, which all medical devices fit into, dependent upon risk and contact length with the human body.

All non-invasive medical devices fall into a Class I, unless their use is for specified purposes as set out by the Directive. They can come into contact with the human body. Class I medical devices do not need a NB and can be put to market immediately as long as the correct procedures have been followed in the MDD essential requirements. These devices include: stethoscopes for diagnosis, incision drapes and all devices used to help mobility including walking sticks, wheelchairs and stretchers. Plasters, wound dressings and devices used to collect bodily fluids, such as urine collection bottles, are also Class I devices, because the risk level of contamination is low and the likelihood of return fluid is minimal. What return fluids mean, is the passing back of the fluid through the medical device into the human body.

Class IIa

These include all non-invasive devices, which are intended for channelling or storing blood, bodily liquids and gases for the purpose of infusion, administration or introduction to the body. This includes active drug delivery systems such as tubing for the passing of liquids into the body, for example, anaesthetic. Class IIa devices also include devices intended to channel blood in and out of the body as well as devices intended to store bodily fluids for a longterm period. The exception to this rule is blood bags, which fall into the Class IIb category.

The class of a medical device should be defined depending on three main areas as set out by the MDD. These are based upon intended use, duration of contact and the degree of invasiveness to the human body. Contact duration is split into three main parts; up to 60 minutes of contact is defined as ‘transient’, up to 30 days is defined as ‘short-term and beyond 30 days in defined as being a ‘long-term’ medical device.

Class IIa medical device syringe

FEBRUARY 2012/ MPN /59

REGULATION REVIEW Class III

Medical Device Classification | REGULATION REVIEW

Class IIb

There is quite often a cross over between Class IIa and Class IIb devices. Class IIb devices are defined as all non-invasive devices where their intended use is to modify the biological or chemical composition of blood, other bodily liquids or other liquids which are intended for infusion into the body. This means that devices, which are intended to remove substances from the blood such as hemodialysers, are classified as a IIb. In addition, wound dressings, which will come into contact with skin that has been broken or damaged and would break below the demis level, will sit in a class IIb, rather than a Class IIa. These include the treatment for chronic extensive ulcerated wounds and severe burns. Class IIb medical device blood bag courtesy of Teknor Apex

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Class III becomes slightly more complex in its definition and some medical device manufacturers may be unsure if their product sits in a Class III or IIb. The MDD states that all medical devices which are used long-term and are surgically invasive currently sit in a Class IIb, unless they are to be placed in the mouth, in which case they would fall into a Class IIa. Or if they were to be used in direct contact with the heart, the central circulatory system or the central nervous system, in which case they would be a Class III. These include spinal needles, replacement limbs, such as hips and biological heart valves and implants made of collagen. All long-term contraceptive devices, such as intrauterine devices (IUDs) also sit in the Class III category. Surgically invasive devices, long-term medical devices and long-term implantable devices A surgically invasive device penetrates inside the body and enters through the surface of the skin, usually during a surgical procedure. This can include minor surgery or major surgical operations, including the implantation of a long-term device. Long-term implantable devices are intended to remain in the human body for longer than 30 days and are introduced as a totally new product to the body. The classification of these devices depends upon their specific use but the majority fall into a Class III device. The exception to this rule is any device intended for use in the teeth, such as a crown or filling. These long-term devices will be classified as a IIb. Any device used in contact with the heart, to be absorbed by the body or to change the way in which a body functions will sit in a Class III, for example a plastic tube which helps pump blood around the central nervous system. Any device intended to stay in the body longterm, such as breast implants or replacement limbs, is classed as a long-term implantable medical device and currently sits as a Class III device. Transient devices used in surgical procedures can also be divided into various classes, and donâ&#x20AC;&#x2122;t necessarily fall into a Class III, despite it penetrating the skin and coming into direct contact with the internal body. For example, surgical instruments, which are used more than once, will fall into a Class I device and can be manufactured straight to market provided the essential requirements from the MDD are met. However, a surgical device which is intended to come in to contact with the central nervous system, will automatically be classed in Class III, despite the fact that it is not intended for longterm use.

Q&A Why is it important that medical device manufactures understand which class their device sits in?

There are several reasons for which classification helps answer the following questions: Route to market

The main route in which a medical device manufacturer can place a product on the market is to use a Quality Management System (QMS) in house, with the use of a Notified Body (NB) to ensure that the product meets the requirements laid out by the MDD. The manufacturer, depending upon the classification of the device, should appoint an NB, but in all cases the Directive rules must be followed and managed in-house by the manufacturer. The QMS means that all manufacturers should be able to produce the design plans, the manufacturing process, the safety procedures and the risk analysis documentation for the NB throughout the process, whatever the class of the product falls into for inspection upon request. Since its establishment in 1993 the MDD has been adjusted accordingly to incorporate new technological advancements, with an additional review currently taking place due for release in early 2012. Following on from this introduction to Classification of medical devices, look out for the next issue of Medical Plastics News, where Short-term medical devices, single use devices and active devices to administer or remove fluids and medicine will be explained.

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Which Conformity Assessment Route is Required? Classification is essential to select the conformity assessment route to demonstrate the device complies with the requirements of the directive 93/42/EEC. Classification has an impact on whether there is a requirement for involvement of a Notified Body, and the necessity for review of technical documentation by a Notified Body.

Is Clinical Investigation Required? Generally clinical investigations are required for implantable and Class III devices, unless existing clinical data can be justified to demonstrate conform with the requirements. Do we need to Include Instructions for use in the Packaging? Instructions for use may not be required to be included in the packaging of each Class 1 and Class IIa medical device if it can be used safely used without any such instructions. Class 1 Registration What could be the potential implications of incorrectly classifying a device?

In the worst case, e.g. devices incorrectly classified and placed on the market as Class 1 (without the intervention of a Notified Body), when they are in fact Class III, IIb or IIa, would be considered as having been illegally placed on the market, resulting in the Competent Authorities needing to take action against the manufacturer to remove such devices from the market to protect the public health. How can medical device manufacturers ensure that they are correctly classifying?

Class III medical device Replacement hip

A very good guidance on classification is available from MEDDEV 2.4/1 Rev 9 ( June 2010); MEDICAL DEVICES: Guidance Document- Classification of medical devices. It can be downloaded from the European Commission website. Where there are doubts or disagreements consult with a Notified Body or Competent Authority.

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FOLIO A SELECTION OF CATHETERS FROM USA-BASED INTERFACE CATHETER SOLUTIONS

FOLIO

COLOUR-CODED CANNULA SYSTEMS MUST BE MADE OF A MATERIAL, SUCH AS EASTMAN TRITAN COPOLYESTER, THAT OFFERS CLARITY AND REMAINS COLOUR-STABLE POSTSTERILISATION TO ENSURE SURGEONS CAN QUICKLY IDENTIFY SEPARATE CANNULAE DURING SURGERY AND HAVE AN UNOBSTRUCTED VIEW.

PRODUCT FOCUS VISTAKEEP PEEK Pump Implant Helps Treat Ascites CE approval for PEEK-based implant from Evonik Help for patients with liver disorders and congestive heart failure he newly-developed ALFAPump System from Sequana Medical Switzerland helps patients suffering from excessive fluid in their abdomen. The battery operated pump implant is based on the PEEK polymer VESTAKEEP from Evonik Industries and has received CE approval. It

pumps the excessive fluid from the abdominal cavity into the bladder, from which it can be excreted by the patient naturally. Up to now, the water has had to be drained using painful paracentesis during regular doctor’s appointments. Patients with liver disorders, congestive heart failure and certain types of cancer

Biostable and biocompatible: the VESTAKEEP PEEK based pump implant. are particularly affected by ascites. The new system consists of a subcutaneously implanted pump and a catheter system: one catheter connects the abdomen to the pump, while the second connects the pump to the bladder. VESTAKEEP PEEK is a polyether ether ketone which is characterised by its biocompatibility and biostability. In contrast to metal, the ion content of VESTAKEEP PEEK is virtually zero, thus preventing shift reactions with the body. What’s more, the PEEK implant is much lighter than a comparable metal implant. The VESTAKEEP PEEK iGrades are specifically suited to long-term use in the human body and can also be made transparent to X-ray on request. “The ALFAPump System not only improves the quality of life for patients but also represents a cost-effective solution,” explains Dr. Noel Johnson, CEO at Sequana Medical. Marc Knebel, Business Management Director, adds, “The ALFAPump System is a perfect example of the many benefits of PEEK compared to metal in this field. Other areas, such as spinal implants, can also benefit from these advantages.”

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EVENTS iSmithers set to hold its Fifth International Conference on Silicone Elastomers Despite their relatively high cost, silicone elastomers are being increasingly used for applications where durability and safety in use are particularly important — such as medical devices. In medical devices and pharmaceutical applications, silicones are used because of their biocompatibility. The impact of the biomaterial on its host environment is assessed according to recognised standards such as ISO 10993, USP <87>, <88> (USP Class VI) and the European Pharmacopeia. A long history of use in medical devices has ensured that silicone elastomers are widely recognised as a biocompatible material in a multitude of applications. For example, increasing concerns in healthcare regarding microbial growth in or on the human body has prompted many medical device design engineers to seek high performance material solutions with built-in antimicrobial protection against the widespread hospital acquired infections (HAIs). With this topic in mind, Dr Burkhard Ledig, Momentive Performance Materials GmbH, Germany will present a paper on positioning silver-based antimicrobial silicones as functional polymers which form one of the first lines of defence in the battle against hospital acquired infections at the Fifth International Conference on 27-28 March 2012 at the Mövenpick Hotel Berlin, Germany. The conference will also address the need for raw material suppliers to ensure that they can offer solutions that are both cost effective and that take into account the increased safety concerns expressed by the healthcare industry operators. Simone Marquardt, Dow Corning GmbH, Germany will discuss how liquid silicone rubbers (LSRs) that have proved their processing efficiencies over the years, can also offer application flexibility in healthcare applications. Drawing on Dow Corning’s expertise in LSRs, the speaker will present the latest research on a new range of materials designed to respond to the needs of modern medical devices applications, taking into account good compression set and tear resistance, technical features and benefits for medical device application, including short-term insert and implantation.

Health in Focus — Synthetics in Medical Technology Up-to-date products and procedures applied in the device industry take centre stage at the VDI convention “Synthetics in Medical Technology”. The event is hosted by the German scienctific association VDI Wissensforum on March 28 and 29, 2012 in Friedrichshafen. The programme includes presentations on manufacturing in dust-free rooms, the technological options of product protection and the improvement of elements and processes through statistic testing and planning. Other subjects focus on modern tools and concepts, user-related design strategies, injection moulding of silicones, requirements regarding extractables and leachables as well as the application of nanoparticles. “I look forward to presenting during the VDI Convention up-to-date technology and topical subjects as well as reports from colleges and research institutions,” explains Dipl.-Ing. Martin Itrich von Gira Giersiepen, head of congress. “The event highlights VDI’s interest to provide a platform for scientists and operators to meet and explore the newest developments, needs and requirements that prevail in this dynamic market.” One day prior to the convention, a separate special event is hosted on March 27, 2012 in Friedrichshafen. The subject is “Producing in China” – Opportunities and Challenges in the Synthetics Processing Industry. The one-day VDI Seminar examines “Going China” from the perspective of synthetics manufacturers and processers and offers viable options for the production of synthetics and medical products in China, or products intended for the Chinese market. The seminar provides a host of knowledge and experience, reports, tips and support. Below: Synthetics in medical technology: the established trade convention at Lake Constance, Friedrichshafen attracts more than 180 visitors.

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EVENTS medical plastics | DIARY 2012

Trade Show - Medical Devices February 14-16, 2012 Anaheim, CA, USA

Conference - Medical Plastics February 29 - March 2, 2012 Las Vegas, NV, USA

Trade Show - Micro Manufacturing March 7-8, 2012 Chicago, IL, USA

Trade Show - Medical Devices March 13-15, 2012 Stuttgart, Germany

Conference - Medical Plastics March 28-29, 2012 Mannheim, Germany

Trade Show - Plastics April 1-5, 2012 Orlando, FL, USA

Trade Show - Plastics April 18-21, 2012 Shanghai, China

Mediplas 2012 - New UK Show Attracts Keen Interest Event Preview: Mediplas 2012 NEC, Birmingham, UK, Sep 23 - 25, 2012 Rapid News Communications Group (RNCG) is pleased to report that the launch of its latest show ‘Mediplas’ has been very well received by the medical plastics sector. Mediplas is a uniquely focused event for the highly specialised area of manufacturing plastic parts for the medical industry. The exhibition will cover all areas of the medical plastics supply chain. The announcement of the new show has sparked a great deal of interest amongst the medical plastics community, with strong evidence to suggest that the show, which takes place in September 2012, will be a huge success. Many companies have already booked their exhibition stands for the debut event. Companies confirmed to date include Zwick Testing Machines, OGP, DS Brookes, Wilde Analysis, Ensinger, Greiner Bio-One, Engel, Fibracon-Insoll, Dalau and Telsonic. The quality and strength of this line up reinforces the organisers’ expectation of a vibrant and exciting show that brings the highly specialised medical plastics industry to a live format.

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Trade Show - Medical Devices May 22-24, 2012 Philadelphia, PA, USA

As well as aiming to provide the medical plastics industry with a show floor packed with the cream of the crop from industry, Rapid News Communications Group, along with key industry partners is working diligently towards providing visitors and exhibitors alike with a high quality and finely tuned conference programme that is set to provide something for everyone. Colin Robinson, Event Sales Manager for Mediplas commented, “Interest in the show launch has been high as evidenced by the initial exhibitor take up and the additional interest shown by our industry partners in getting involved and supporting the event. Having successfully staged Interplas for the first time in September 2011 we are now well placed to build on this success and deliver a focused and exciting event for the medical plastics industry across Europe for many years to come.” Mediplas 2012 will take place on 25-26 September 2012, Hall 3a, NEC, Birmingham, UK, and will be co-located with TCT Live, MM Live UK, MEMS Live UK and Sensing Technology.