MPN EU Issue 18 by MPN Magazine

MPN

MEDICAL PLASTICS NEWS

Biomaterials and the quest for bone apposition â&#x20AC;&#x201D; a new PEEK-OPTIMA grade that could fill the gap

ALSO IN THIS ISSUE: Regenerative medicine Molecular weight Catheter finishing Processing software

ISSUE 17 March-April 2014 WWW.MEDICALPLASTICSNEWS.COM

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All Medical, All Plastics

Contents

Cover Story — Page 10

5. Editor’s Letter: Getting to know you The new MPN editor, Lu Rahman, introduces herself and discusses important aspects of the medical industry. 6. On the Pulse: News from the industry, featuring TML, Wittmann Battenfeld, ProTek and Gerresheimer.

Materials — page 14

10. Cover story: The Next Generation in Materials for Interbody Fusion: PEEK-OPTIMA HA Enhanced Invibio Biomaterial Solutions presents its new material. 14. Materials: Material Gains Lu Rahman dicusses the role of highperformance polymers in replacing metal in the medical device market.

Regenerative Medicine — page 18

18. Product Focus: Regenerative Medicine An article on tissue regeneration by Michiel van Alst, Corbion Purac Biomaterials. 23. Process Control Software: RJG Introduces its eDART Version 10.6

Catheter finishing — page 34

24. Assembly: Assembling Soft Components Union Plastic’s answers to key issues related to soft components and elastomer parts assembling.

26. Molecular Weight: A Key Characteristic of Medical Plastics James “Jim” Rancourt of Polymer Solutions talks about this important aspect of polymers. 32. X-RAY 6000: Versatile and individual for the most widely ranging requirements, news from Sikora. 34. Catheter finishing: Shedding Light on Laser Catheter Processing An article by David Gillen and David Moore of Blueacre Technology. 39. Design 4 Life: Could we 3D print medical devices in the home? Daniel O’Connor, The TCT Magazine, discusses the possibilities of widely available 3D printed medical devices. 45. Design 4 Life: The Future of 3D Printing in Healthcare: A Practitioner’s View Matt Hlavin of rp+m presents his experiences of 3D printing in the medical sector and gives his predictions for the future. 48. Events: A Preview of ANTEC 2014 48. UK National Institute for Health and Care Excellence to Produce Medtech Innovation Briefings 50. Events: MEDTEC France 2014 Preview

Online and in digital Design 4 Life — page 39 Disclosure: Medical Plastics News charges an undisclosed fee to place a contibutor’s image and headline on the front cover.

Medical Plastics News is available online at our website www.medicalplasticsnews.com and via a digital edition. MARCH-APRIL 2014 / MPN /3

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EDITOR’S LETTER

GETTING TO KNOW

you

ith three days under my belt as a financial contribution government recognises new addition to the Medical it can make going forward. Plastics News team and I’m faced Value such as this doesn’t create itself. with the task of writing the editor’s comment. Innovation, expertise and strong business On one hand it’s fairly daunting as I haven’t acumen are crucial. While 3D printing, amid even been here a week but conversely, it has much hype and chatter, has only just hit given me a great opportunity to see the mainstream media, it has of course been in sector from the ‘outside’. existence for years and the sector is now Growing up in a medical family, I was used looking at applications for 4D printing. A to seeing medical devices around the house. sector that is pushing the boundaries with Of course, I’m not suggesting I was the technological advancement and innovative product of careless parents thinking is always a (however, whoever thinks pleasure to be part of. doctors are a careful breed When the ultimate aim is should think again) but it to improve the lives of has to be said that quite individuals, that innovation Maintaining a often I would find syringes starts to come to the fore. competitive edge, and implants sitting next to me on the dining table (they investing in skills Important issues never did learn not to leave Coming to the publication a child, a drink, a sister and a for today’s market from energy journalism, syringe in close proximity) yet to get under the and future growth, I’ve and I clearly remember the skin of this sector. overcoming supply However, just a few days in time my dad went into exquisite detail explaining it’s clear there are chain challenges and and the workings of a common themes and replacement hip, in a bid to issues relevant to success pushing the persuade me — aged nine and profitability, whatever boundaries to — into a medical career. the market. Maintaining a His enthusiasm gave me competitive edge, increase profit a strong sense of the work investing in skills for involved in this field so it’s a margins and market today’s market and future privilege to now be able to leadership are vital growth, overcoming hone that interest and be supply chain challenges to success able to get underneath the and pushing boundaries to skin of sector and its success. increase profit margins Looking at the statistics surrounding the plus market leadership, are vital to success and market, it is clear this industry has every just some of the areas I am keen to find out reason to shout its worth and be recognised about as well as the technological for the contribution it makes to the global advancements being made on a continual economy and well being of us all. According basis. I am also keen to gain an insight into the to a report by visiongain, the medical device pressures your business faces and their effect industry was worth $320bn (£191.8bn) on profit margins. As issues of sustainability globally in 2012 and its strength can be become increasingly important, for example, tracked by its success in outperforming the how does this marry with technological pharma industry growth-wise. advancement and innovation? I’m looking forward to meeting many of Longterm success you and coming to understand how your It is estimated that this year the medical business overcomes challenges, the best device contract manufacturing market will practice you can share with others and your reach $49.45bn (£29.64bn) with revenue views on the sector now and for the future. growth set to continue at a strong pace until Medical Plastics News is your voice so feel free 2024. The medical polymer market itself looks to get in touch to share your thoughts and likely to rise by more than half over the next expertise — I’m looking forward to getting to five years to reach around $3.5bn (£2.1bn) — know as many of you as possible. an increase of around 52% from 2013 to 2018. It could be argued that recent moves in Lu Rahman, the US to introduce a tax on medical devices EDITOR underline the success of this sector and the

CREDITS

editor | lu rahman acting editor | aleksandra wisniewska advertising | gareth pickering art | sam hamlyn production | peter bartley production | tracey roberts publisher | duncan wood Medical Plastics News is available on free subscription to readers qualifying under the publisher’s terms of control. Those outside the criteria may subscribe at the following annual rates: UK: £80 Europe and rest of the world: £115 subscription enquiries to subscriptions@rapidnews.com Medical Plastics News is published by: Rapid Life Sciences Ltd, Carlton House, Sandpiper Way, Chester Business Park, Chester, CH4 9QE T: +44(0)1244 680222 F: +44(0)1244 671074 © 2014 Rapid Life Sciences 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)

MARCH-APRIL 2014 / MPN /5

TML Celebrates its ISO 13485 Milestone

s leading injection moulder Thornbury Manufacturing Limited (TML) approaches the fifth anniversary of its ISO 13485 qualification, TML founder and director Dick Walsh reflects that attaining the standard has been one of the most valuable achievements of the business to date. A good percentage of TML’s manufacturing output is located in the growing medical and dental markets. There is no doubt that gaining ISO 13485 has helped focus and project the company’s general excellence in technical moulding to the right kind of medical and dental purchasers and specifiers. Helped by success in medical and dental areas TML has outpaced the revival in the UK’s SME manufacturing performance over the past three to four years with double digit growth posted for the business over that time. Investment in new Battenfeld injection moulding machinery and other equipment has also helped TML to raise its production volumes in recent months. “We value our partnership with Wittmann Battenfeld UK,” notes Walsh. “Our customers and clients expect continuous and fault-free engineering and production from TML — and these are the qualities that we find mirrored in our growing fleet of Battenfeld injection moulding machines.” To achieve ISO 13485 TML built upon the existing design and manufacture capabilities already encapsulated in its ISO 9001 standard, the business having been certified in this manner since January 1997. Walsh notes that the ISO 9001 standard was “a helpful prerequisite for ISO 13485; since the disciplines for a clean, quality assured mould shop had been long established before we went further and took the plunge into ISO 13485; adding further processes to guarantee safe and capable product management.” TML is located in the UK’s South West in the Plymouth area and was founded nearly 20 years ago in order to match ongoing growth in technical trade moulding. The business has grown from strength to strength since and now employs some 30 people operating on a site footprint of nearly 20,000 sq feet.

6/ MPN / MARCH-APRIL 2014

<< LEFT | Figure 1: The latest new Battenfeld injection moulding machine at TML. >> << ABOVE | Figure 2: Part of suite of tools/mouldings used to manufacture instruments for micro surgery. >>

Helped by success in medical and dental areas TML has outpaced the revival in the UK’s SME manufacturing performance over the past three to four years with double digit growth posted for the business over that time.

Medical device manufacturing will continue to be a key part of the TML business. All TML’s measuring equipment is calibrated and recorded and SPC and AQL checks are also carried out as requested by TML’s customers. Energy saving measures and green initiatives are also a key part of TML’s successful modus operandi. The company has worked successfully with the Carbon Trust in commissioning equipment to reduce energy cost and a recent LED lighting programme has also reduced energy outgoings in that area by some 400%.

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Gerresheimer Extends Medical Devices Operations in the US

erresheimer AG, one of the world’s leading partners of the pharma and healthcare industry, is extending its production capacity for medical plastic systems at its plant in Peachtree City, Georgia, USA. The production area will be increased by an additional 5,600 m2 (60,000 square feet). Production of new medical devices will start following completion of the infrastructural enlargements. Gerresheimer is investing double digit million dollars in the project in Peachtree City, which will create around 120 additional jobs in the mediumterm future. “We’re experiencing worldwide growth in demand for user friendly, safe and easy-touse medical devices such as inhalers and insulin pens. As a result of this growth, and new customer projects, our excellent plant in Peachtree City will be significantly increasing its production capacity. There are a great many opportunities for us in this business segment in the US, and our Peachtree City facility will play a crucial role in helping us to exploit them. We greatly appreciate the generous support of the state and local authorities in Georgia in this challenging project,” commented Andreas Schütte,

member of the management board of Gerresheimer AG with responsibility for the Plastics & Devices Division. The additional production area will significantly increase Gerresheimer’s Peachtree City plant’s production capacity. Two thirds of the additional production area will be ISO class 8 cleanroom. Gerresheimer is taking advantage of Georgia’s internationally acclaimed workforce training program, Quick Start. The approximately 120 new jobs to be created in the medium term will include executive, administrative, supervisory and production positions. “Georgia’s healthcare industry is uniquely poised to help Gerresheimer grow,” said governor Nathan Deal, State of Georgia, USA. “This leading global company is taking advantage of an eager, skilled workforce and an advanced life science and healthcare ecosystem. Our state is the ideal location to support Gerresheimer’s newest expansion.” Gerresheimer established its first Peachtree City production facility in 1993 and expanded it in 2009 with the establishment of

<< The Gerresheimer production site in Peachtree City, Georgia, USA. >> a Technical Competence Center (TCC). The plant in Peachtree City is part of Gerresheimer’s Medical Plastic Systems business unit. Gerresheimer Headquarters is based in Düsseldorf, Germany. Peachtree City and the other plants in this business unit develop, industrialise, manufacture and assemble customer-specific devices such as inhalers, insulin pens, lancets and various diagnostic systems.

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MARCH-APRIL 2014 / MPN /9

THE Next Generation IN MATERIALS FOR INTERBODY FUSION:

PEEK-OPTIMA HA ENHANCED PEEK Proven and Accepted in Interbody Fusion For more than a decade, PEEK-OPTIMA Natural, the first medical grade unfilled PEEK from Invibio Biomaterial Solutions, has been utilised in spinal fusion surgeries, predominantly in the form of load-bearing cages. Today, PEEK is the most popular biomaterial for interbody fusion devices. Clinical studies continue to suggest that PEEK-OPTIMA performs as well as, or better than equivalent interbody fusion devices made of metals or allograft, while providing some distinct clinical advantages over competing biomaterials. The properties that make PEEK-OPTIMA one of the leading interbody fusion biomaterials; modulus similar to cortical bone, imaging compatibility, biocompatibility and processing adaptability, make it an ideal platform for tailoring to specific needs. Previous examples of this have included addition of carbon fibre to increase strength, or barium sulfate to increase visibility under X-ray.

<< Figure 1: Representation of available surfaces for bone on-growth (highlighted in blue) with PEEK-OPTIMA HA Enhanced and Ti-coated PEEK devices. >>

Now, despite the clear benefits offered by PEEK-OPTIMA Natural, surgeons are interested in methods to enhance direct bone apposition to interbody fusion devices. In this article, we introduce a new biomaterial offering, PEEKOPTIMA HA Enhanced, which addresses these growing needs. Desire for Increased Osseointegration In recent years, one area in which the desire for increased osseointegration has been evident has been in the trend for interbody fusion devices in which titanium surfaces have been incorporated with PEEK cages. A potential limitation of some technologies however, especially plasma spray coatings, is the inability to coat all surfaces, including the walls surrounding the graft space; thereby limiting the available area for bone ongrowth. PEEK-OPTIMA HA Enhanced is a new biomaterial introduced by Invibio, bringing together PEEK-OPTIMA and hydroxyapatite (HA) to address the growing surgeon need for increased osseointegration, and the market drive towards materials that play a more active role in the fusion process. This new material, in which the HA is fully integrated in the PEEK matrix, is a promising solution for medical applications such as spinal interbody fusion, where early bone apposition would be advantageous in achieving early stability. Unlike a conventional coating technology, the even and homogenous dispersion throughout the PEEK matrix, ensures HA is made available on all machined surfaces of a final device for potential bone on-growth (figures 1 and 2). HA is the main inorganic constituent of bone. Due to its wellknown osteoconductive properties, naturally occurring and synthetic forms of HA have been successfully applied for many years as a bone void filler and as a coating for orthopaedic and

10/ MPN /MARCH-APRIL 2014

<< Figure 2: HA distribution and availability at the surface of a PEEK-OPTIMA HA Enhanced interbody fusion device. The HA is indicated by the speckling on the surface. >> dental implants to ensure fixation, without obvious materialrelated bio-incompatibility reactions. Indeed, the use of HA in spine applications is not entirely without precedent. A number of pedicle screw systems, including the Dynesys Dynamic Stabilization system (Zimmer Spine) and the Transition stabilization system (Globus Medical Inc.) made HA-coated titanium screws available for the purpose of improved early screw fixation. Development of a High Performance Polymer Ensuring the same high performance as PEEK-OPTIMA Natural was a key aim in the development of PEEK-OPTIMA HA Enhanced and in defining its suitability for use in interbody fusion devices. The incorporation of HA into the PEEK matrix has had minimal impact on mechanical properties (see table 1), whilst maintaining similar imaging characteristics (figure 3). Research Results: Early Bone Apposition Whilst bench testing and in vitro studies can provide some information on material performance, ultimately a pre-clinical study is needed to demonstrate efficacy where osseointegration is concerned.

COVER STORY

<< Figure 4: Implantation sites in cortical bone (tibial diaphysis) and cancellous bone (proximal tibia and distal femur). >> << Figure 3: Fluorographic imaging of PEEKOPTIMA Natural and PEEK-OPTIMA HA Enhanced cervical interbody fusion devices (lateral view). >>

For this reason, Invibio commissioned a study to evaluate the in vivo response of PEEKOPTIMA HA Enhanced compared with PEEKOPTIMA Natural in a large animal model. The study was carried out at the Surgical & Orthopaedic Research Laboratories, University of New South Wales (UNSW) under the direction of Professor Bill Walsh, following approval of the UNSW Animal Care and Ethics Committee.

Increasing demands are being placed on biomaterials for use in interbody fusion applications. The trend in methods to improve osseointegration of PEEK-based devices, principally through coating technologies, underlines this fact.

The study used implants in the form of simple cylindrical dowels that were implanted in an established ovine model. Endpoints for the study included implantation into cortical and cancellous sites in adult sheep followed by radiography, mechanical testing and PMMA histology at four and 12 weeks following implantation. Surgery was performed in a bilateral fashion using the anteromedial aspect of the tibias and the medial distal femoral condyles for implantation using a previously reported model (figure 4). For implantation in cancellous bone (distal femur and proximal tibia), implants were inserted in a press fit manner. For the cortical implantations in the tibia, implants were placed in a line-to-line manner.

Fluorochrome labels were administered at intervals during the four- and 12-week implantation periods to provide a dynamic view of new bone formation. At harvest, each bicortical implant was cut in half, perpendicular to its long axis, allowing preservation of one half of the implant for histology, whilst the other half was used for mechanical push-out testing. Implantation sites were also radiographed at harvest to acquire anteroposterior and lateral views of the implants in situ. Integration of the implants was tested by measuring the implant-bone interface shear strength using a standard push-out test. Briefly, specimens were tested at 0.5 mm/min on a calibrated servo-hydraulic testing machine. The thickness of the cortical and cancellous bone samples was measured and the values used to calculate the shear stress. Following retrieval, samples were fixed and dehydrated prior to embedding in poly(methyl methacrylate) (PMMA). Samples were then sectioned perpendicular to the long axis and stained using methylene blue - basic fuchsin. The histology images from cortical bone sites were examined to determine the percent bone on-growth based on a semi-quantitative grading scale. From the radiographs, no adverse reactions were noted in either the PEEK-OPTIMA or PEEK-OPTIMA HA Enhanced group. Similarly, the histological examination revealed no adverse reactions in the adjacent cortical bone, cancellous bone or Continued on page 13

<< Table 1: Comparison in mechanical properties of PEEK-OPTIMA Natural and PEEK-OPTIMA HA Enhanced. As can be expected from the introduction of a new biomaterial for long-term implantation, biocompatibility is a pre-requisite, and Invibio have also completed a comprehensive suite of testing, from chemical analyses and cytotoxicity testing to long-term implantation, in accordance with ISO 10993. >>

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COVER STORY

<< Figure 5: Grading of direct bone contact for PEEK- OPTIMA Natural and PEEK- OPTIMA HA Enhanced at 4 and 12 weeks. >>

adjacent marrow. Histological review and grading did however demonstrate a marked increase in the degree of direct bone contact with PEEK-OPTIMA HA Enhanced compared with PEEKOPTIMA Natural at both the four week and 12 week time points (figure 5). With PEEK-OPTIMA Natural, some areas of direct bone contact were observed, whilst in others there were gaps or small regions of fibrous tissue in the intervening space. For PEEK-OPTIMA HA Enhanced, a more consistent and continuous degree of direct bone contact was observed (figure 6). The use of fluorochrome labeling supports the notion of early bone apposition. The appearance of alizarin red labelling on the surface of PEEKOPTIMA HA Enhanced indicates that bone was being deposited as early as 10 days following implantation — the time at which the fluorochrome was administered (figure 7). In contrast, early bone apposition was not observed with PEEK-OPTIMA Natural. Finally, push out testing demonstrated increased interfacial shear strength with PEEK-OPTIMA HA Enhanced compared with PEEKOPTIMA Natural at four weeks following implantation (figure 8), << Figure 6: Four week histology of (a) PEEK-OPTIMA Natural, and (b) PEEK- OPTIMA HA Enhanced. Solid and open arrows show gaps and areas of direct bone contact respectively. >>

providing further evidence of increased osseointegration. Important to note is the absence of any additional surface geometry used in the implants, which may have influenced both shear stress and percentage bone-in-contact values. Surface roughness was also a consideration in evaluating osseointegration and so all implants, machined from both PEEK- OPTIMA Natural and PEEK-OPTIMA HA Enhanced, were machined to have a similar surface roughness (Ra ≈ 1 μm). Increasing demands are being placed on biomaterials for use in interbody fusion applications. The trend in methods to improve osseointegration of PEEK-based devices, principally through coating technologies, underlines this fact. Despite the long clinical history and performance of PEEK-OPTIMA Natural, Invibio has risen to the challenge in addressing this need from both surgeons and implant manufacturers. The introduction of PEEK-OPTIMA HA Enhanced, bringing together two well-accepted biomaterials, delivers one unique combination for enhanced bone apposition. << Figure 7: Alizarin red labelling (arrows) demonstrates bone formation on the surface of PEEK-OPTIMA HA Enhanced 10 days following implantation. >>

MARCH-APRIL 2014 / MPN /13

MATERIALS

MATERIAL GAINS How high-performance polymers have a key role in replacing metal in the medical device market WORDS | Lu Rahman

ver recent years, the trend for replacing metal parts with high-performance polymers has increased, not least in the medical device sector. Advantages such as lighter weight, resistance to higher temperatures and degradation plus displaying high strength and ACCORDING TO SOLVAY toughness, have made SPECIALITY POLYMERS, these materials costeffective alternatives to DESIGNING WITH traditional materials like PLASTICS ISN’T HARDER, metal. As medical device JUST DIFFERENT. AS PART manufacturers face increased price pressures, OF ITS DRIVE TO PUSH new ways of looking at THE USE OF product development HIGH-PERFORMANCE processes are becoming increasingly important.

POLYMERS FOR METAL REPLACEMENT, THE COMPANY IS OFFERING ITS EXPERTISE AS WELL AS GOING ONE STEP FURTHER TO CREATE A REAL LIFE CASE STUDY OF ITS OWN TO HIGHLIGHT THE ADVANTAGES OF POLYMERS IN MEDICAL DEVICE DESIGN.

Solvay Speciality Polymers, a global supplier of medical grade thermoplastics, is at the forefront of the drive to replace metal with high performance polymers in the medical sector.

Dane Waund, global market manager for healthcare at the company explains: “We think of ourselves as more than a plastics company. Solvay is part of the healthcare sector and supply chain. As such, we feel the need to educate and pass on best practices where we can be of benefit.”

As medical device manufacturers face increased price pressures, new ways of looking at product development processes are increasingly important. Confidential agreements Active in the metal replacement market for over 20 years, Solvay has developed considerable expertise. Bound by confidentiality agreements, however, with its OEM partners, the company has been unable to publicise much of its work highlighting the extreme suitability of polymers as a replacement for metal in the medical sector. “We recognise that specifying plastics for medical devices can be daunting for those who have been used to working with and designing with metals. So, we offer our expertise and help, and provide a step-by-step process and practical advice to make the change,” says Waund. Visitors to the American Academy of Orthopaedic Surgeons (AAOS) in New Orleans will have witnessed Solvay’s expertise first hand as the company hosted an educational summit at the conference. The first of several to be held this year at a range of global locations, the event is designed to enable the company to move closer to the customer, offering insight and information on critical topics at various levels in the healthcare field.

Continued on page 16 14/ MPN /MARCH-APRIL 2014

MATERIALS Continued from page 14 Presenting a paper on “Coming to Grips with Specifying High Performance Plastics: a Surgical Retractor Metal Replacement Case Study”, Waund revealed Solvay’s recent project on metalto-plastic conversion engineered via a seven-step procedure that analysed end-use performance, biological safety and economics. It also offered techniques to demystify the challenge of metal replacement.

Next step innovation “We decided to take our innovation to another level,” reveals Waund, “Because we can’t openly discuss the work we are doing with our customers, we made the decision to develop our own case studies highlighting the benefits of using polymers in medical applications.” As a result, Solvay developed designs for both single and repeat use medical applications, replacing traditional metal instruments with alternatives using medical grade plastics. “We selected a Hohmann retractor for this replacement project,” says Waund. “As a popular part and one that is commonly used in surgery, the device offered plenty of challenges, such as the mechanical load the instrument has to bear, for us to be able show that high performance polymers can be used as a replacement material.

“Polymers offer several advantages for the medical device sector. One of the main drivers is cost. This makes their application for single-use devices feasible. There has also been considerable interest in product appearance and ergonomic designs that are comfortable and offer a range of grip options. Basically, the polymers we are working with here enable the design of instruments which offer comparable performance to stainless steel but with added advantages,” he says. Solvay selected two of its high-performance plastics for the metal replacement study. Exhibiting prototypes utilising the products at the AAOS gave Waund a feel for how they would be received. Positive reaction “The response was extremely positive,” he says. “The fact that we can colour code them to avoid confusion was popular as was their durable feel. Someone commented, ‘when you think of plastic, you don’t think of this,’ which was encouraging to hear.” For single-use medical devices, the company worked with Ixef polyarylamide (PARA) due to its strength, excellent surface finish and compatibility with gamma radiation sterilisation. “This polymer is ideal for single-use applications,” says Waund. “It may prove particularly relevant in preventing the re-use of single-use devices, as the material visually impairs when autoclaved.”

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“We think of ourselves as more than a plastics company. Solvay is part of the healthcare sector and supply chain,” says Waund.

For repeat-use devices, Solvay used AvaSpire polyaryletherketone resin (PAEK), which is tailored to provide what it describes as unique combinations of performance and value. Ideally suited “PAEK provides a range of features making it well-suited for repeat-use medical devices,” says Waund. “This includes a high stiffness to weight ratio, hydrolytic stability at elevated temperatures, improved ductility and toughness, excellent chemical resistance as well as fantastic aesthetics and colourability.” Stiffness is a critical requirement for retractors, making PAEK ideal for these applications. It is also easy to process, allowing device designs to incorporate long, thin geometries to be produced either via extrusion and machining or injection moulding. “The combination of hydrolytic stability and chemical resistance make high-performance polymers ideal for the manufacture of repeat-use devices. This is especially crucial throughout the cleaning and sanitation process, which involves aggressive chemical cleansing and steam sterilisation. This can be a tough challenge for many plastics to face, but PAEK copes well,” says Waund. Solvay is keen to recognise the companies it has worked with in the process to hone this high performance polymer expertise. “Between us and the customer is a raft of additional expertise such as injection moulding, rapid prototyping, stock shape suppliers and machine houses,” says Waund. “For this study we particularly benefited from collaborations with Paragon Medical, Mack Medical and Total Plastics, who provided their expertise and cost analysis.” The project has clearly paid dividends for the company, which is making definite in-roads into highlighting the benefits of highperformance polymers in the medical device sector. As Waund points out: “There is a lot of metal to replace,” making this area of medical device technology potentially very profitable for those involved.

MARCH-APRIL 2014 / MPN /17

PRODUCT FOCUS

<< Figures 2a - 2c: Woven structure in a hand and foot, images courtesy of Scaffdex. >>

Tissue Regeneration Michiel van Alst | Director new business development & marketing, Corbion Purac Biomaterials

he ability of the human body to recover after injuries, trauma and diseases is both remarkable and astonishing. If this were not the case young children might not be so willing to learn how to walk, run and jump, and at the very least, their parents would not be so keen to support this development enthusiastically. The capacity of the human body to heal wounds and restore tissue like skin is something we perceive as natural and normal. However, in cases where the injury is too severe or complicated our bodies need technical support. Tissue Engineering is the field of science providing this technical support enabling regeneration of tissue or, as described in 2012 by IUPAC, as “use of a combination of cells, engineering and materials methods, and suitable biochemical and physic-chemical factors to improve or replace biological functions.” With a growing, aging and more active population, the need for engineered tissue — spare parts — is growing drastically. Concept The implanted products are in most cases temporary support structures that, once implanted, will be converted into the required final tissue. The strategy therefore is to produce a temporary scaffold to enable cell attachment, cell proliferation and cell differentiation either in vitro or in vivo. The temporary scaffold has to comply to several requirements in order to be able to regenerate the involved tissue. Amongst others, the scaffold should be biocompatible and allow cell growth. In order to do so, the material needs to be shaped in a porous interconnected network and exhibit proper mechanical integrity during the healing response once implanted. The porous structure enables the cells to be close enough to each other, while allowing blood flow into the scaffold to stimulate cell growth and differentiation. Additionally, proliferation and cell differentiation (when stem cell are used ) are dependent on the mechanical properties of the scaffold. In many cases, cell response is also influenced by external stimuli, such as strain and forces on the cells and scaffold. Mechanical support of the implant during the initial stage

18/ MPN /MARCH-APRIL 2014

<< Figure 1 >>

just after implementation as well as during the healing period is of key importance. During the healing or regeneration phase, the mechanical property of the support structure is gradually replaced by the regenerated tissue. Proper material selection, processing techniques and design of the implant are crucial to the proper functioning of the product and its commercial success.

<< Figure: 2b >>

<< Figure: 2c >>

Tg (°C)

Tm (°C)

E (GPa)

σm

ε-break

(MPa)

(%)

Degradation* (months)

PL 38

180 - 190

3.1 - 3.7

2–6

> 24

PDL 20

3.1 - 3.7

2–6

12 - 16

PG 20

215 - 225

6.5 - 7.0

100

1–2

6 - 12

PC 12

-60

55 - 65

0.2 - 0.3

> 300

> 24

PLC 7015

105 - 115

0.02 - 0.04

> 300

12 - 24

PLG 8531

140 - 150

3.3 - 3.5

2–6

12 - 18

PURASORB grade

<< Table 1. Properties of selected PURASORB polymers >> * Time to complete mass loss. This depends a/o on processing method, device geometry implantation site.

Resorbable polymers The use of resorbable polymers in a vast number of commercial applications, their ability to be processed by common manufacturing and sterilisation methods and their regulatory history make these polymers ideal candidates for tissue regeneration devices. Resorbable polymers such as (co)polymers of lactides, glycolide and ε-caprolactone have been widely used for more than 40 years in applications such as surgical sutures, orthopedic devices like interference screws and fully resorbable, drug-eluting vascular stents. The scaffold is designed to disappear and to be replaced by tissue grown in and/or by the body. Figure 1 shows the concept of an implanted temporary scaffold. The healing response or regeneration of tissue and the corresponding mechanical requirements differ per tissue. The design of the scaffold, material choice and processing technology can and should be tailored to the specific application. By altering the chemical composition of the resorbable polymer a large variety of physico-chemical and degradation properties can be achieved. Table 1 shows specific properties of selected resorbable PURASORB polymers such as pure poly(L-lactide) (PL38), polyglycolide (PG 20), poly(ε-caprolactone) (PC12) and various copolymers. Polymers based on lactides, glycolides and εcaprolactone are developed, manufactured and marketed by Corbion Purac Biomaterials under the PURASORB brand name.

Manufacturing technologies In order to produce the desired scaffold structures a large variety of manufacturing technologies can be utilised. Electrospinning, salt-leaching and foaming techniques create structures that are often further modified by reticulation or textile technologies. All these technologies have distinct features that influence the behaviour of the scaffold to a great extent. Furthermore, sterilisation methods such as EtO or E-beam, should be selected carefully as they will effect surface characteristics of the scaffold and therefore the corresponding cellular response. Products In the development of scaffolds for tissue engineering the input from clinicians in close cooperation with material scientists, as well as the input from processing and design engineers is of great importance for the successful development and commercial success of these products. A tissue engineered structure based on a temporary, resorbable construction offers significant advantages over permanent, non-resorbing implants. In paediatric patients this is immediately apparent as a permanent implant lacks the ability to grow along with the patient. Additionally, some implants, such as artificial heart valves, need to be able to serve their mechanical requirement throughout the patient’s life. This imposes very Continued on page 20 MARCH-APRIL 2014 / MPN /19

PRODUCT FOCUS

<< Figure 3: Creation of a printed scaffold for the cranium repair. >>

high demands on any permanent implant with respect to wear and fatigue, increasing the likelihood of premature implant failure. The Reg Joint small joint implant initially developed at Tampere University of Technology in middle 90s is a braided scaffold based on extruded resorbable fibres. Finnish company Scaffdex licensed this innovation and acquired CE approval for it in 2011. It is indicated for usage in small joints in hand and foot for patients who are suffering from severe osteo or rheumatoid arthritis, as shown in Figure 2. Instead of fusion of the joint and the resulting rigid outcome, the Reg Joint implant forms a durable, flexible and functional pseudojoint. The unique combination of the productsâ&#x20AC;&#x2122; geometry and material provides the required properties for these types of applications, allowing patientsâ&#x20AC;&#x2122; bodies to more closely restore initial function. In many applications the need for patient-specific, customised implants is of key importance in the success of the product. New technologies and advances enable customisation of scaffolds to an unprecedented level. Technologies, such as 3D printing can be applied in various applications that previously could only be addressed with inefficient, labour-intensive methods. Figure 3 shows the process of designing, manufacturing and implanting a resorbable scaffold for a cranial bone defect. These

Continued on page 22 << Figure 4a: Polycaprolactone polymer scaffold of a porous and hollow ear. The scaffold will be filled with stem cells and chrondro inductive cells. >>

20/ MPN /MARCH-APRIL 2014

<< Figure 4c: End result of a 3D printed ear. Figures 4a-c courtesy of Ernst Jan Bos MD, from the Department of Plastic and Reconstructive Surgery VU University Medical Centre, Amsterdam. Figures 4b and 4c have been created in ccoperation with the Technical University Delft, the Industrial Design Department. >> << Figure 4b: Method for an ear model based on the CT scan of the actual ear in order to establish a perfect fit. >>

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PRODUCT FOCUS Continued from page 20 products were developed in Singapore and applied to hundreds of patients to date. The CT scan of the patientâ&#x20AC;&#x2122;s cranium serves as the input for the design of the scaffold. The scaffold is then produced using fused deposition modelling (FDM), yielding a porous scaffold, which is seeded with cells in vitro and implanted. Another example of how 3D printing enables customisation of scaffolds in complete parity with the patients need can be seen in figure 4. This shows a 3D printed scaffold of an ear. After severe burning, organs like noses and ears may in the future be replaced using these types of scaffolds. The 3D-printed and resorbable scaffold contains a mixture of cells and other constituents allowing the regeneration of the cartilage of the ear or nose lost by the patient in vivo.

Conclusions Opportunities in tissue regeneration products based on temporary scaffolds of resorbable polymers are enormous and require multidisciplinary product development. New developments in processing technologies, understanding, awareness and familiarity with resorbable polymers, innovative products based on this unique family of materials is on the rise in tissue regeneration applications.

<< Figures 5 and 5b: The woven structure, courtesy of Corbion Purac Biomaterials. >>

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PROCESS CONTROL SOFTWARE

RJG Introduces its eDART Version 10.6

JG‘s advanced process monitoring and control system is now even simpler to use. The touchscreen-friendly eDART interface still enables the users to minimise inherent process variation that is common in moulding facilities and allows the manufacturer to produce repeatable parts of superior quality. By controlling the process and implementing part containment manufacturers guarantee that no bad parts are shipped to the customers. The eDART System was the first digital sensor and data acquisition platform for injection moulding. Having the industry’s first digital ‘smart’ sensors with mould identification capability, for years the eDART System has been considered a powerful and easy-to-use process monitoring and control system geared specifically for injection moulding. Experienced and inexperienced eDART System users will find that process set-ups have been greatly simplified and the software screens are even easier to understand and navigate. Much of the decision-making has been streamlined by limiting the amount of information the user needs to input to get the process running. New features include an easy-to-read history of alarms and process changes and a Mold Configuration Assistant. It’s now easier to match machine set ups with the ability to view the template values along with the actual values. This means you are spending more time processing and less time learning the software.

The Version 10.6 eDART Software release includes the following enhancements: l

l l l l l l

Improved the Velocity to Pressure Setpoint interface making it easier to make setpoint changes while viewing the cycle graph Valve Gate Control Sequencing capability has been added as an optional tool Shuttle/rotary table interface has been added A sensor list and summary page has been added to the end of the mould setup for setup verification The cycle values interface on the cycle graph now displays the actual value and template value on the bar graph Additional template control capabilities Added support for Analog Water Flow and Water Temperature devices.

Version 10 eDART System users can download this update free of charge at www.rjginc.com.

MARCH-APRIL 2014 / MPN /23

ASSEMBLY

Assembling Soft Components Union Plasticâ&#x20AC;&#x2122;s answers to key issues related to soft components and elastomer parts assembling Despite the fact that soft components like lip seals, oâ&#x20AC;&#x2122;rings, sleeves and gaskets are often widely used in sophisticated medical devices, their assembly is often an issue. Compared with rigid plastic parts, components that are made of moulded silicone rubber, TPEs, soft PVC, bromobutyle or VLDPE have a high dimensional variability and their behaviour in the automated processes might be unpredictable. Union Plastic, a major European player in designing and manufacturing medical or diagnostic devices and drug delivery systems, has built an approach allowing it to implement new multiple assembling lines for such parts. The company, now employing 200 people, agreed to share its method. Here are the key points of the successful implementation of a new assembling line processing one or several soft parts: Soft components source: as they can either be in-house moulded or outsourced, from a single tool or even from several suppliers, their dimensions and mechanical properties have to be checked and mastered. Union Plastic chooses to measure them using vision technology, which prevents parts from sensor impacts on their shape, and gives more reliable results. Adding surface roughness check, compression or stress relaxation measurement might also be useful. Supply chain: when components are moulded in-house, cooling and shrinkage times must be taken in to consideration, and the product flow diagram will include large buffer areas. The extended production and warehousing teams have to be involved in this process. Feeding: this step is often the most critical, because of the roughness variation ranges one can meet on such materials. All components feeding devices, like hopper, vibrating bowls and conveying rails will require dedicated coating, with special sliding 24/ MPN /MARCH-APRIL 2014

properties. When this is not enough, parts lubrication by medical grade powders or liquid silicone can also help. High speed assembling: their variable parameters make soft parts assembling more complicated than rigid components, especially when you reach high speed rates, above 100 shots per minute. For instance, Union Plastic advises to design an assembling process, which overcomes part roughness, as the surface can often change from one batch to another. It is also interesting to smoothly stress the parts before mounting, in order to homogenise their shapes. Complex treatments: adding processes like ultrasonic welding, or high frequency formatting on a line can often create a bottleneck, and must be taken into account in the line layout. 100% in process controls: as soft components assembling can damage them, Union Plastic systematically adds a checking station at the end of the line. This can be based on pushing strength measurement, video inspection, leak testing by pressure drop, or even combining two technologies together. Vision technology is now in most cases the fastest and smartest choice. The large variation range of the mechanical soft components parameters also obliged the company to implement specific qualification processes. For instance trials matrixes were extended to include new variables, like lubrication rate or parts temperature, and new combinations. Then trending studies shall be carried out along the product life, according to each source, tooling or raw material. As a conclusion, with 50 years of proven performance on the healthcare market, Union Plastic has the strong willingness to make further progress in multi-components devices. www.union-plastic.com

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MOLECULAR WEIGHT

A Key Characteristic of Medical Plastics: MOLECULAR WEIGHT James “Jim” Rancourt, Ph.D., founder & ceo of Polymer Solutions Introduction Plastic materials are a critical component to the supply chain for the manufacture of safe medical devices. The incorrect use of plastics can lead to frustration, lost time, wasted money and product failures. The correct use of plastics allows for the implementation of innovative product designs, unique device features and cost-effective manufacturing processes. How well the plastic performs throughout its lifecycle, and the mechanisms through which a plastic can fail, are both strongly influenced by polymer molecular weight. The molecular weight of polymers is critical to know and understand. In end-use applications numerous issues can arise with components of medical devices or even with the medical device packaging. Implants can fail prematurely, bioabsorbable polymers may degrade at the wrong rate, medical tubing may become embrittled, packaging materials may become yellowed, and medical devices may crack. The cause of failure can be determined using a variety of analytical methods. A common starting point is to determine the molecular weight of the plastic material.

26/ MPN /MARCH-APRIL 2014

Simply put, molecular weight is the size of the molecule. For example, if 2,000 styrene chemical repeat units are linked together, the molecular weight of the polymer is 208,000 because the formula weight of the styrene repeat unit is 104. As molecular weight increases, the impact resistance, abrasion resistance, tensile strength and melt viscosity also increase. Higher molecular weight polymers can be more difficult to manufacture, more expensive and difficult to process into finished parts. Therefore, from a practical perspective, there is a range of molecular weight values that are most desirable for a specific product and process. Molecular Weight When confronted with product failures, those who are tasked with the root cause analysis often want to rule molecular weight in or out as a contributor to the failure. That is best accomplished by comparing the molecular weight of the failed portion of the product with a non-failed control sample. This is a cost-effective approach because there is not a ‘correct molecular weight value’ Continued on page 29

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MOLECULAR WEIGHT

for any plastic part. The comparison is a rapid assessment that determines if the molecular weight has decreased significantly or not. If the molecular weight has not decreased significantly, molecular weight has quickly been ruled out as a primary factor in the failure mechanism. Alternatively, if the molecular weight has decreased significantly, the team members next look to the cause of the molecular weight reduction to initiate corrective actions. Changes to Molecular Weight Every step in the life of a plastic can alter the molecular weight of the polymer chains and thereby influence the physical properties and performance of the product. An example of the molecular weight of a plastic declining is provided by considering a bioabsorbable implant device. The plastic starts as raw polymer whose molecular weight is dropped as a result of thermal and hydrolytic degradation that occurs during the moulding operations. Next, sterilisation significantly degrades the molecular weight further as a result of molecular chains being broken by the sterilisation process. During storage for modest periods of time, in properly designed storage containers, the polymer molecular weight remains stable. Then, as designed, the polymer degrades substantially as a result of being implanted. An explanted bioabsorbable polymer may retain virtually no polymer chains. The progression of molecular weight for this scenario is provided in the table below.

Stage of Life

DSV (dL/g)

Raw Material

5.5

Moulded Component

3.5

Sterilised Product

1.8

Stored Product

1.7

Explanted Device

<0.1

Two points to be understood from the previous example are the following. First, for the implant to operate properly and be degraded to low molecular weight by-products in the desired time frame requires a specific molecular weight. Second, in order to achieve the starting molecular weight for the implanted bioabsorbable polymer, the polymer must start with a higher molecular weight. The higher starting molecular weight is critical because it is known that processing will lower the molecular weight and that sterilisation will lower the molecular weight even further. The molecular weight attained after moulding and sterilisation must be repeatable and must attain the target value. The Methods and the Numbers There are two primary methods that are used to determine molecular weight, dilute solution viscosity (DSV) and gel permeation chromatography (GPC). Both methods can be used for decision-making purposes by the team members. Dilute Solution Viscosity Dilution solution viscosity measurements are relatively inexpensive, can be performed quickly with a small amount of sample, and provide a single numerical value that is related to the molecular weight of the portion of the sample tested. The basic principle of the method is a comparison between the flow rate of a solvent through a capillary tube and the same solvent containing dissolved polymer. The dissolved polymer decreases the flow rate of the polymer in proportion to the molecular weight of the polymer. If a failed sample is compared with a control sample, the following scenarios may occur:

Continued on page 31

Measured Dilute Solution Viscosity Values, dL/g

Sample

Scenario 1

Scenario 2

Scenario 3

Control

3.5

No Control Available

Failed Part

3.4

1.8

1.7

CONCLUSION

No Difference

Significant Difference

Experience-Based Decision or More Analysis

MARCH-APRIL 2014 / MPN /29

30/ MPN /MARCH-APRIL 2014

MOLECULAR WEIGHT Continued from page 29 l

In the first example, the team can conclude that the molecular weight of the failed sample and the control sample are not significantly different. As a result, other contributors to the failure need to be identified and investigated.

In the second example, the team can conclude that the molecular weight of the failed sample and control sample are significantly different. The team will then work to determine the cause of the molecular weight reduction.

The third example is the weakest position to be in when working to determine a root cause analysis: there is no control sample and no baseline data with which to compare the dilute solution viscosity values. Now, the investigating team needs to assess the reasonableness of the value to make a determination as to whether or not molecular weight is a plausible cause of the failure. This decision may be based on the experience of a team member who knows the DSV value that represents an appropriate molecular weight for the polymer. It is wise to proactively acquire DSV values for critical polymers so that scenario three does not occur.

Gel Permeation Chromatography Understanding that molecular weight is the ‘size’ of the molecules that comprise the plastic leads to the next component of molecular weights and plastic materials. The actual molecular weight of plastic materials is always a distribution, not a single value. For example, the polystyrene described above, having a molecular weight of 208,000 is present as part of a collection of molecules that have some polystyrene molecules that are smaller and others that are larger than 208,000. Scientists and engineers refer to this as ‘the molecular weight distribution.’ The average molecular weight can be determined quickly and relatively inexpensively with simple DSV measurement equipment. However, the complete distribution of molecular weights that comprise a sample can be assessed by using a gel permeation chromatograph (GPC). This instrument separates the molecules based on their size and the detectors are able to ‘count’ the number of molecules of each size. The resulting data set includes the average molecular weight as well as the full distribution of the molecular weights that comprise the sample. Simply knowing the average is not always enough information, a molecular weight distribution graph is information-rich.

Summary A common starting point in a failure analysis investigation is to determine the molecular weight of the plastic material. Two common methods of analysis are used for this purpose, dilute solution viscosity (DSV) and gel permeation chromatography (GPC). The DSV provides a single number that is representative of the entire molecular weight distribution. In contrast, the GPC method provides the complete molecular weight distribution curve. It is wise, and a best practice, to proactively

benchmark the molecular weight of critical polymers by obtaining DSV or GPC data sets. This ensures a baseline data set is available during a failure analysis investigation. About the Author James “Jim” Rancourt, Ph.D., is the founder & ceo of Polymer Solutions, an independent chemical analysis and physical testing lab. He has decades of experience with analytical chemistry and is recognised as an authority in the field of polymer analysis.

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X-RAY 6000: Versatile and individual for the

ascinating versatility is the hallmark of the X-RAY 6000. In extrusion lines where e.g. medical tubes are produced, the X-ray measuring device provides continuous compliance with the required specifications regarding wall thickness, eccentricity, as well as the inner and outer diameter. With this device, quality control is carried out directly during the production process. With the two models, X-RAY 6000 for the quality assurance of single layer products, and the X-RAY 6000 PRO for the measurement of single and multi-layer products, the X-ray measuring system can be individualised to suit every application and requirement. This makes it the perfect offer for different customer demands because the application field of the X-RAY 6000 system is most diverse: both single layer or multi-layer tubes, medical and cosmetic tubes, aluminium composite tubes, pressure hoses with textile reinforcement, small or large diameter hoses made of PE, HDPE, PVC, as well as foamed products, products made of EPDM, nylon, rubber or silicone, are reliably measured by the system.

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<< Figure 1: SIKORAâ&#x20AC;&#x2122;s X-RAY 6000 system ensures the quality of medical tubes already during the production process. >>

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Depending on the requirement (hot or cold measurement), the X-RAY 6000 may be installed in any position in the production line. Directly with the online measurement, the measuring values for wall thickness, eccentricity, inner and outer diameter and for the ovality are displayed at the processor system ECOCONTROL 6000. The wall thickness values are shown at eight points and allow the operator to centre the crosshead. On the 22” vertical widescreen monitor of the X-RAY 6000 PRO, the production data is clearly displayed. With the use of the X-RAY 6000 as measuring head at the hot end, directly after the extruder or after a first vacuum tank/cooling trough, it is possible to rapidly centre the crosshead and to control the line speed or extruder rpm. An additional diameter gauge after the vacuum tank/cooling trough, combined with a hot-cold control, considers the material shrinkage. In combination with the processor system ECOCONTROL 600, 1000 or 6000, an automatic control of the line is possible. By controlling the line speed or extruder rpm, the product parameters are adjusted to the nominal dimension. The typical return time (ROI) for the investment is six to eight months. www.sikora.net

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<< Figure 5: Features cut into PEEK Tube. >>

Shedding Light ON LASER CATHETER PROCESSING

David Gillen and David Moore, Blueacre Technology

n recent years the production of catheters has advanced at a fast pace and as the volumes increase, more emphasis is being placed on bringing value-added processes and functionality to the customer. Laser machining brings a number of options to the device designer, allowing a range of finishing processes which can add both functionality and value to catheter products. Blueacre Technology based in Dundalk, Ireland, designs laser micro machining systems, provides contract laser micro machining services for the medical device industry and has performed extensive development in-house to optimise the laser machining of polymer catheters. The findings of these developments have revealed the advantages and manufacturing challenges that must be overcome for efficient and effective laser machining of the polymer tubing that is the basis for catheter devices. This article will look at a range of laser processes developed for both single layer and multilayer extruded catheter devices. General Requirements Laser micro machining of polymer catheters requires the consideration of factors not normally encountered during laser processing. As polymers inherently have less stiffness than metals, polymers tend to move around more than metals during laser machining. This problem becomes more significant when machining small features (<50 Îźm) on thin-walled tubes. Blueacre Technology has developed a number of advanced autoalignment systems, which offer the ability to track the tube position in real time. This allows for high cutting speeds while

34/ MPN /MARCH-APRIL 2014

holding tight tolerances over long parts and offering accuracies better than 5 Îźm. In addition, the developments that Blueacre Technology has performed mean that very little post-processing of laser machined polymer tubes is required. For instance, it can be the case that the only post-processing required for laser machined catheters is cleaning in an ultrasonic bath, which lowers production costs. Full Length Catheter Marking In the past pad printing of inks onto catheters has been the main process whereby marks are added as indicators of position or for part traceability. However, with advances in how laser beam delivery has been integrated with part handling systems, it is now possible to laser mark over the full length of a catheter device. Blueacre Technology has developed equipment capable of marking over catheters over a metre in length. As the marks are part of the catheter material, they do not suffer from biocompatibility and fading issues associated with traditional pad printing techniques. Catheter Ablation Guiding catheters come in many forms but such devices require lubricity, steerability and trauma minimisation. Therefore guiding catheters tend to have a lubricious PTFE inner liner, an antikinking braid and a soft but sturdy outer layer of nylon or PEBAX.

CATHETER FINISHING

<< LEFT | Figure 1: Section of catheter that has undergone laser ablation. >>

<< RIGHT | Figure 2: End of catheter that has been stripped and cut by laser. >>

An area where Blueacre Technology has worked is in selective laser ablation of the outer nylon/ PEBAX layers of guiding catheters, leaving the inner braid and undamaged. Figure 1 shows an image of a section of catheter that has undergone laser ablation. A key aspect of this process, to keep the inner liner from suffering from heat related shrinkage and careful control of both the laser power and laser wavelength, is necessary. In fact, choosing the correct laser wavelength is the most important aspect of catheter processing. As catheters are primarily polymer devices, it must be remembered that each polymer has its own unique laser absorption fingerprint. Given that it is the absorption of laser light that controls machining quality, it is generally necessary to choose a laser wavelength that matches the polymer being machined. However, this can also work in favour of the device designer and by choosing polymer layers that are known to absorb light at different wavelengths, it is possible to design devices that have very controlled laser machining properties. In certain circumstances by adding small levels of additives to the extrusion, it is possible to control the absorption of particular polymer layers. A particular example would be co-extruding an inner layer of nylon with an outer layer of additive â&#x20AC;&#x2DC;nylonâ&#x20AC;&#x2122;. If the right additives are chosen, it is possible to make the outer layer absorb the laser light, whereas the inner layer is transparent. Catheter Finishing Once a catheter is ablated the end is removed to allow a functional distal tip to be added. One of the issues with cutting the end from a laser stripped catheter it that there is no longer a restraining force on the braid, which can un-coil. Figure 2 shows a catheter that has been cut using a laser process developed by Blueacre Technology. This cutting process prevents the braid

from un-coiling and allows a distal tip to be overmoulded without an increase in profile diameter. This distal end could be made from a polymer of lower durometer for reducing trauma, or else be a more active tip made from a functional polymer. Side Hole Cutting As medical technology develops, so does the demand to cut holes in the side walls of catheters. There are a number of applications for catheters with such side holes, from drug infusion to arterial flushing. The core requirement for side holes is to produce a feature that has a clean edge without any burr or raised portions. An example of catheter holes in a polyimide catheter is shown in figure 3. Laser machining allows holes down to 10 Îźm in diameter to be drilled with both high precision and tolerance. For multilayer materials, there are a number of issues. As described above, the absorption of the laser by both polymers must be considered, however it is possible to machine very clean features in multilayer materials that include PTFE/Nylon combinations. The drilling of side holes in braided catheters has a number of issues, as the inclusion of a metal layer adds increased process requirements on the laser. If the hole is not machined with minimal heat input, the outer layer can soften, the braids can push outwards and the profile increases. In the worst case scenario the braids can protrude through the outer layer, leading to the possibility of trauma. Figure 4 shows images of holes drilled into the sidewall of braided catheters, and with careful choice of laser parameters it is possible to cut clean holes with no damage to the braid.

Continued on page 36 MARCH-APRIL 2014 / MPN /35

CATHETER FINISHING Continued from page 35 PEEK Processing Although multilayer braided catheters are used for advanced delivery applications, there is a range of catheters that rely on engineering polymers such as PEEK and polyimide. PEEK and polyimide are very similar materials to such an extent that, from a laser perspective, they share the same laser parameter space. Given the resistance of materials such as PEEK to aggressive chemicals and high temperatures, they are considered as being engineering polymers and lend themselves to a wide range of functional applications. As with metal components such as stainless steel and nitinol, the laser is a well-placed tool to machine these polymers with high accuracy and tolerance. An example of the features that can be cut into a PEEK tube is shown in figure 5 and they range from basket-type devices, through small holes and spirals, to tailor flexibility. It is striking how similar to metals these features are, showing the diverse range of applications for PEEK. Polyimide is more prone to kinking than PEEK, but as shown in figure 3, a laser is capable of removing large sections of polyimide from the catheter without effecting the overall integrity or form of the tube.

<< Figure 3: Holes laser-cut into a polyimide catheter. >>

As an example of how fine the features can be, figure 6 shows a stent structure machined into a PEEK tube. The quality of the sidewalls is high and it is possible to attain struts widths down to 20 μm without any heat damage or melting occurring.

<< Figure 4: Holes laser-drilled in braided catheter with PTFE liner and Nylon outer layer. >>

VistaMed, a Helix Medical joint venture company, is a leading thermoplastic extrusion and catheter provider to the medical device industry worldwide. VistaMed provide innovative solutions to challenging complex extrusions including high pressure braided tubing. Vistamed’s Polyurethane, Nylon reinforced, High Pressure Braided Tubing (HPBT) used in high pressure applications such as the injection of contrast media is available in different formats offering; - Superior resistance to dimension distortion under pressure - Constant working pressure of 1200 psi - Burst pressure over 1700 psi. Contact VistaMed today to see how we can be the perfect fit for all your catheter needs. VistaMed IDA Business and Technology Park, Carrick-on-Shannon, Co.Leitrim, Ireland. 36/ MPN /MARCH-APRIL 2014

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<< Figure 6: Stent pattern cut into PEEK tube. >>

Visit www.microlumen.com to learn more.

<< Figure 7: Circuit structures laser etched in metal coated tubes. >>

Future Techniques Laser processing of catheters has come a long way in the last few years, partly through more advanced lasers, but also through a greater understanding of how the laser interacts with the polymer at a basic atomic level. Blueacre Technology has been using these insights to develop new techniques that enable electrical circuits to be integrated with catheters. Using catheters as both active and passive sensors is not a new concept, however it has involved the co-extrusion of the metal conductors into the sidewalls of the catheters. This makes the overall profile of the device large, thereby restricting the application areas to intestines and larger arteries.

Blueacre Technology has developed a process whereby electrical circuits can be directly written onto flexible polymer sheets. In the past these devices have been used as ‘wearable’ technology in a range of applications. This technique was developed for flat surfaces but has now been transferred to catheters, where the laser can write circuits on the outside curvature of the catheter walls. This removes the need for the co-extrusion of bulky wires and makes the catheter itself into a functioning circuit. Figure 7 shows a range of patterns laser machined on the side wall of catheter and these shapes are limited only by the feature size of the laser, which can be as low as 10 μm.

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DESIGN 4 LIFE << Figure 1 >>

Could we 3D print medical devices in the home? Daniel O’Connor, The TCT Magazine f you read, hear or see about 3D printing in the mainstream media you’ll believe that the technology will not only have us shot, but also save our lives afterwards. Stories about 3D printed arsenals and 3D printed cures are commonplace amongst breakfast television sofas and tabloid column inches alike.

Nick Allen, director of 3DPRINTUK, told us: “We’re seeing a growing trend in enquiries from the medical industry, we print a lot direct from CT scans for universities. We use laser sintered Polyamide, which has great accuracy when printed, it is strong and really cost-effective. “

The common misconception running through these news stories is that we can now print a gun or a car at home on machines that cost from as little as $499 (£300, €360). This is simply not true, what is true is that industrial 3D printing/additive manufacturing is now reaching the plateau of productivity according of Gartner’s Hype Cycle whereas consumer-based 3D printing is just about to plunge into the trough of disillusionment.

Though the medical applications of industrial 3D printing are vast, from bespoke implants to medical device prototypes, from in vitro regenerative to dental reconstruction, there is an unexpected market appearing on the horizon: homemade, primarily plastic, 3D printed medical devices.

The term ‘3D printing’, applies to numerous technologies, each with their own individual properties. In the main, plastics come in three states: in powdered form for laser sintering, resins for curing with a laser, or plastic filament, which is then molten and extruded. All the processes build up objects layer-by-layer, allowing complex internal structures to be made in one print. One of the key applications for growth in industrial 3D printing is medical; a report last year by Transparency Market Research anticipated that by 2019 the medical 3D printing market would be worth $965.5 million (£622.6 million) compared with $354.5 million it was valued at in 2012.

Prosthetics for the people Carpenter Richard Van As was working in his shop in May 2011 when his dominant right hand slipped and severed all four fingers. He decided in the emergency room that, if he were to continue to make a living from carpentry, he would have to make his own working fingers. Not perturbed by the naysayers who told him it couldn’t be done, Van As began digitally working with mechanical engineer Ivan Owen, who specialised in puppetry, on a 3D printable prototype for functioning digits. Owen in San Francisco, and Van As in Johannesburg, may have been separated by 10,000 miles but, owing to the fact they both had a donated MakerBot Replicator 2 on their desks, they were able to prototype and redesign in real time. It quickly became MARCH-APRIL 2014 / MPN /39

<< Figure 2 >>

apparent that the 3D printed prototype parts needed not to be moulded or traditionally tooled; the printer could make the majority of the working parts, accurately, quickly and also cheaply.

needs a replacement then the Robohand’s printed parts can be safely disposed of.” Robohand now has three devices working: Robofinger to improve fine motor skills; Robohand to provide gross grasp and the Roboarm with gross grasp and rotatable wrists. Whether they be amputees or people with birth defects, Robohand and some traditional intensive physiotherapy has now helped in excess of 200 people feed themselves, throw a ball, shake hands and do just about anything a regular hand can do.

Their hard work has spawned a working fully customisable prosthetic, 90% printed PLA — the most popular plastic in consumer 3D printing — with some cheap hardware store wire, nuts and bolts to allow mechanics to work. The materials cost of the average Robohand is thought to be just $2.50 USD. Robohand’s director of communications, Leonard Nel explained to us why PLA is the only material it uses. “Robohand has a ‘DO NO HARM’ philosophy. When we’re fitting a prosthetic, PLA is pliable at a lower temperature than ABS (the other readily available 3D printing plastic) so we are not scalding the skin of the patient. DO NO HARM is also applicable when it comes to the renewable sources that PLA is derived. It is also biodegradable, so when a child grows and

The demand for cheap prosthetics is through the roof; according to the International Society of Prosthetics and Orthotics, there are over 32 million amputees in the world today, around 80% live in developing countries where only 5% have been fitted with an artificial limb. One such developing country where Robohand is being put to use is Sudan.

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DESIGN 4 LIFE << Figure 3 >>

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The war in Sudan has left over 50,000 amputees and an organisation that uses technology for the sake of humanity, Not Impossible Labs decided to take the Robohand idea and implement it in Sudan. It started with Daniel, who had his arms blown off at the age of 14. After Dr Tom Catena had helped the project leader, Mick Ebeling, produce a tailored, working arm and hand for Daniel, he fed himself for the first time in two years. Helping just one person was never the aim, the proof of concept that was Daniel breathed life into the project. Not Impossible Labs implemented a system for the Sudanese to print prosthetics themselves. Since Ebeling has left Sudan a PLA 3D printed arm a week has been printed in the facility. “We believe Daniel’s story will ignite a global campaign,” said Ebeling. “The sharing of the prostheses’ specifications, which Not Impossible will provide free and open-source, will enable any person in need, anywhere on the planet, to use technology for its best purpose: restoring humanity.” Material Matters Consumer 3D printers tend to be FDM machines; the plastic filament that is molten inside the extruder heads of these machines is evolving at a rate of knots. The exponential growth in desktop 3D printing, which a report from Reportsandreports.com suggests could be worth $5 billion by 2017, means the two traditional polymers sold with the printers — ABS and PLA — no longer cut the mustard. Mike Garey made the news recently for 3D printing a prosthetic foot for an amputee duck named Buttercup in his waterfowl sanctuary. He told us: “Without the development of this new material, NinjaFlex, it would not have been possible to 3D print a working prosthetic for Buttercup; I’ve tried several types of filament and none give the required durable elasticity that this

DESIGN 4 LIFE

NinjaFlex gives. I’m now able to print a durable solid PLA part with a flexible part in the same machine.” NinjaFlex is just one of many new thermoplastics developed specifically for desktop 3D printing. This patent pending specifically formulated TPE filament is the first 3D printing development by Fenner Drives, a worldwide leader in the design and manufacture of added-value, problem solving products for power transmission, motion transfer and conveying applications. It is clear from that company description that NinjaFlex was a development made for in-house use and then released to the wider world. The current trend in 3D printing is for more plastics with varied properties, wood/polymer and cement/polymer are becoming more popular among artists and sculptors, while the amount of Nylon and Polyester materials available for home printing has gone from practically zero to saturation in the space of six months as evidenced by consumer giant MakerBot’s recent foray into “Flexible Filament” — a 2-oxepanone, homopolymer supplied by Perstop Winning Formulas. More materials = more applications The possibilities for medical applications for consumer 3D printers don’t just stop at prostheses either. Just last week we saw a report in the Courier Journal on how Erle Austin of University of Louisville Physicians took a CT scan of a child’s heart and printed a 3x scale version on a $2,000 desktop machine. Austin said: “Once I had a model, I knew exactly what I needed to do and how I could do it. I found the model to be a game-changer in planning to do surgery on a complex congenital heart defect. It was a tremendous benefit.”

Continued on page 44

MARCH-APRIL 2014 / MPN /43

DESIGN 4 LIFE

<< Figure 6 >>

The Cortex is a 3D printed nylon cast system for fracture support that was nominated for the James Dyson Award in 2013. The design by New Zealand student Jake Evill involves a lattice print that becomes more concentrated in the affected area. Though currently manufactured with an industrial printer, it is not unforeseeable that, should 3D printers and materials reach a substantial level, doctors could prescribe a cast for the fracture patient to print at home (see figure 3). Another project, A-Footprint is an EU funded joint-research initiative led by Glasgow Caledonian University, its aim is to bring to market cost-effective, high-speed, personalised foot/ankle orthoses. The process developed by A-Footprint, along with various partners including Peacocks Medical Group, takes 3D imagery of a patient’s foot and uses that data to 3D print a perfectly tailored innersole or splint for said patient. We asked Dr Jari Pallari if it was a possibility for these innersoles to be printed at home. He said: “Machines and materials, ease of use and making sure your print won’t do you more damage means at the moment, no. But if there was sufficient clinical assessment and the assessor was certain you could accurately print that part at home then it is possible. You’d have to sign a tonne of disclaimer documents though.” Standardisation vs. Democratisation It is clear from Dr Pallari’s comments that the medical industry would be reluctant for users to print medical devices in their own 44/ MPN /MARCH-APRIL 2014

homes, but with the rapidly advancing material sciences, developing machines and widespread digital information available, health services could soon be fighting against a tidal wave of self diagnoses and treatment. In the early days of 3D printing it was said that the hackers and hobbyists printed with “anything they could get their hands on”, which is why PLA and ABS remain so prominent in the materials. The haphazard approach to material science means relatively little was known about the source and safety of the materials. A report on Science Direct suggested that printing with ABS and PLA emitted high levels of Ultrafine Particles that could be potentially damaging to one’s health. Though the report did state that: “…the same 3D printer utilising a higher temperature ABS feedstock had an emission rate estimate (1.8-2.0×1011 #/min) similar to that reported during grilling food on gas or electric stoves at low power (1.2-2.9×1011 #/min)” it has prompted more care and diligence by the major 3D printing suppliers. Most plastic filament is purchased online, when purchasing filament materials data sheets have increasingly become available. Though standard practice when selling plastic as a raw material, this is relatively unchartered territory in the home. FDA approval of home 3D printing filament is rare but with a growing number of food and drink implements available to download as well as these new medical applications it is only a matter of time before we see some sort of standardisation and regulation.

DESIGN 4 LIFE

The Future of 3D Printing in Healthcare: A PRACTITIONER’S VIEW

Matt Hlavin, CEO, rp+m

Printing is making strides with new materials, processes and software every day. The access to all the different processes of the 3D printing technology today has opened up the art of the possible for all industries and positions. Whether it’s a new design of a product, an invention of a medical device or surgical tool, 3D printing is an asset to invest in to help the medical product development cycle. There are many materials and techniques that can be used in 3D printing. Traditionally, rp+m (rapid prototype + manufacturing) has focused on 3D printing polymer materials, however, recently we made a company decision to spread our wings into 3D printing metals. rp+m has also invested in a R&D team who will be engaged throughout the entire engagement process with clients. Our biomedical, design, mechanical, metallurgist, and

plastic engineers are devoted to all medical programs coming into our company to provide product design, material selection, prototype, regulatory assistance, quality systems and production. 3D Print Skulls, Surgical Tools and Imaging Machines Surgeons are using 3D printing to their benefit in multiple ways. Recently, surgeons have reached out to rp+m’s team to 3D print patien’s skulls prior to going into surgery. Doing this will allow the surgeon to understand true sizing to their patients’ skull and trauma. At rp+m we have the capabilities to take a CT Scan, turn the file into a 3D model and produce the skull in our 3D printers. Surgeons will use the traumatised skull replication to understand the exact size of the trauma to practice placement of the device or devices before the actual surgery takes place, saving the surgeon time and the patient money.

Continued on page 46 MARCH-APRIL 2014 / MPN /45

DESIGN 4 LIFE

Continued from page 45 Our biomedical engineers at JALEX Medical help surgeons design surgical tools that are customised to the way the surgeon would like. While surgeons use many surgical tools, the majority of them do not fit and function the way the surgeon desires. Tools may be too big or too small, and the doctor would prefer its shape to be different in order to enhance performance. Our biomedical engineer experts will work with doctors and surgeons to fully understand what they are looking for. Using a CAD software, our device designers will take the idea and create a 3D model. In order to ensure the surgical tool fits and functions exactly how the surgeon wants, we will 3D print a prototype of the product so they can touch and feel before going into production. Expanding into Metals While rp+m’s core business has focused on the polymers’ technology of 3D printing, we are now expanding into 3D printing metals. This opens the door for new end-use devices and medical industry technology. As one of the companies at the forefront of the 3D printing phenomenon, we are the first company in the world to be able to 3D print Tungsten. Our partner, Radiation Protection Technologies (RPT), has years of experience in moulding product that is a lead replacement and shields radiation while having the same density as lead. There are many different applications for using the material including ballast weight, medical imaging machines, industrial and ammunition. Although we have seen success in moulding this material, the medical customers, who are the large OEMs for medical imaging equipment, told us they need something faster. At rp+m we took the initiative to work on developing a similar material to be used on our ExOne Binderjet additive manufacturing machine. We are now able to 3D print components for medical imaging equipment on demand without the need of capital expenses, such as tooling, saving our clients time and money. With the acceleration of technology maturation in the metals space, all materials classes including metals, polymers, ceramics, electronic and biomaterials can be manufactured using 3D technologies. Today, the metals technologies are becoming not just performance competitive but cost competitive enough to engage industrial users beyond just the first adopter metal and aerospace companies. This will soon integrate further in the medical industry.

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“Enriched design capabilities are also enabled by metal powder bed fusion technologies like BinderJet and Direct Metal Laser Sintering (DMLS). This allows for high performance metal powders to be used in larger quantity,” says Edward Herderick, PhD, director of R&D at rp+m. What is to come in the future? The materials and processes for 3D manufacturing will continue to mature to the point where a new paradigm of “Manufacturing by Design” will emerge to replace the current paradigm of design for manufacturing processes. This will allow the medical industry to have customised devices for their patients. Similar to snowflakes, every body and bone structure is different from one another. Having customised devices will permit a better fit. In the future we see the medical trend in additive manufacturing increasing dramatically. Within the next few years, we are hoping to additively manufacture implantable devices including cages, artificial hips, spine screws, rods and discs. We will be on the forefront of this trend. rp+m’s biomedical engineers as well as their R&D group handles development of material, design of medical devices, regulatory and quality systems assistance where clients will come to rp+m from start until commercialisation due to convenience of all expertise being under one roof.

EVENTS

ANTEC 2014 28–30 April 2014, Las Vegas, Nevada, USA ANTEC is the largest conference in the US dedicated specifically to plastics.

Medical Plastics News readers are invited to join SPE and accomplished expert speakers from around the globe as they present the latest practices and trends currently influencing the plastics industry. This year, the expanded programme will include the premier Global Parts Competition. Don’t miss this opportunity to learn and network with representatives from some of the largest industry segments. The highlights of the conference include: plenary speakers and new technology sessions each day, over 600 technical presentations, tutorial sessions and panel discussions, exhibit floor with more than a hundred industry representatives, student and young professional sessions and programme. The advance programme is now available on the Antec website. Monday’s Advances in Packaging session looks at: l Reducing food waste by extending shelf life through innovations in lightweight plastic l Ionomer resins that easily disperse in hot water l Interactive package communications to the consumers l How product vision for a hot beverage cup brought solidstate micro cellular plastics into widespread use

Turning process challenges into opportunities in the production of packaging l Recent advancements in the use of polypropylene for packaging. Tuesday’s Medical New Technology Forum entitled ‘Plastics in the Hospital and the Human Body’ will feature the following topics: l Silk nano fibres less than 50 nm in diameter manufactured using a special electrospinning process and used for medical applications such as wound healing scaffold for burns l One can fabricate protein-based polar nano fibres that can be used for small sensor and energy harvesting technology, or that a simple peptide is able to hybridise with collagens undergoing either normal or pathological remodelling l Soft matter physics can be used to design novel light transmission polymers for healthcare l Why solvent adhesives are becoming obsolete in medical applications, and the 100% solids adhesive options are the newly commercially viable products? l Why global regulatory harmonisation efforts are underway for review and approval of combination medical devices? For more information and to register for the event, go to www.antec.ws/

UK National Institute for Health and Care Excellence to Produce Medtech Innovation Briefings

n a major step towards improved coordination between clinicians and suppliers of medical devices, the UK’s National Institute for Health and Care Excellence (NICE) is to start developing Medtech Innovation Briefings. The briefings comprise a new product to support healthcare staff considering using new medical devices and other medical technologies. NICE is one of the most important references used by healthcare practitioners in the UK when deciding upon certain treatment pathways. The briefings will be produced by the Medical Technologies Evaluation Programme at NICE, which already produces guidance on innovative medical devices and diagnostics. The new Medtech Innovation Briefings will provide a description of the medical technology and how it’s used, including its potential role in the treatment pathway. The costs of using the technology and a review of relevant published evidence will also be covered. By making this information available, NICE hopes to help avoid the

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need for NHS organisations to produce similar information for local use. Professor Carole Longson, director of the NICE Health Technology Evaluation Centre, said: “We’re delighted to be undertaking this new stream of work producing Medtech Innovation Briefings. We hope that they’ll help clinicians, health managers and procurement professionals with their local decision-making, by providing objective information on device and diagnostic technologies. These briefings are not NICE guidance — they won’t contain recommendations, nor will they say whether or not a technology should be used. That decision will be made by local health professionals. We plan to publish the first briefings in early 2014, and hope that they’ll become a useful addition to med tech products that we currently provide.” More information on the Medtech Innovation Briefings will be available at http://www.nice.org.uk/mib.

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EVENTS

MEDTEC France 2014 The biggest event in the medical device industry for French-speaking countries will take place in Lyon on 9 and 10 April 2014.

ll the key players in the medical device industry will converge upon Lyon for the sixth edition of MEDTEC France. As the largest gathering of the French medical device industry, MEDTEC France combines conferences and a trade fair, showcasing the sector’s entire range of technologies and expertise. A new panel of experts with ever greater knowledge of the market’s needs This year, two conference programmes will be offered in parallel in order to better meet the needs and address the concerns of the sector’s stakeholders. All the statutory authorities in the medical device sector will take part to provide information and discuss the following topics: • Implantable medical devices: review of the current market for implantable devices, clinical needs, challenges and technological progress, • Connected medical devices: review of the current market, clinical needs and enabling technologies, • Single-use medical devices: presentation of solutions to reduce the cost of materials and manufacture, new packaging and sterilisation solutions, and regulatory issues, • Traceability of medical devices: in particular with respect to unique device identification (UDI) and its implementation in Europe, • Regulatory affairs: in France, Europe and the USA. New for 2014 With a programme of high-quality conferences closely structured around the needs of companies within the sector, MEDTEC France 2014 will break fresh ground with two major forums: • MEDTECH Entrepreneur & Start-up Forum: Based on various round table sessions to discuss current challenges and share feedback between entrepreneurs in the medical device sector, start-ups and experienced consultants in the fields of funding, intellectual property, regulatory affairs and commercialisation. • The Employment Forum will be held in partnership with the network of French biomedical engineering schools. The 2014 edition will also include the second Innovation Awards in recognition of original and innovative projects implemented in the design and manufacture of medical devices. For the second year running, MEDTEC France will present Innovation Trophies in recognition of original and innovative projects implemented in 2013 in the design and manufacture of medical devices. An exceptional panel of judges will meet to decide on the top three of the 12 shortlisted projects.

Members of the 2014 judging panel will include: • Faraj Abdelnour, president of ACIDIM (association for executives in the European medical devices industry) • Professor François Chapuis, MD, MPH, PhD, clinical research centre manager - Pole IMER (medical information evaluation and research hub) at Hospices Civils de Lyon • Dr Florence Ghrenassia, director - Pharm. D, Exec. MBA, OTT&PI (Office of Technology Transfer, Licensing and Industrial Ventures) DRCD/DMA (department for clinical research and development/medico-administrative division), AP-HP • Joël Guillou, director of regulatory affairs, reimbursement and market logistics, SNITEM (French association for the medical technologies industry) • Alain Ripart, scientific advisor, Sorin Group • Marie Zwarg, healthcare sector manager - department for innovation expertise, healthcare and life sciences industry, Bpifrance. www.medtecfrance.com

“With its enhanced programme, MEDTEC France 2014 will be an unmissable event, addressing the needs and expectations of the medical device sector and showcasing innovations in healthcare. We look forward to seeing you there. We will be in touch soon with further information.” Fabienne Valambras, Event Manager for MEDTEC France

The results will be announced and the trophies awarded at 12.30 on Wednesday 9 April 2014.

50/ MPN /MARCH-APRIL 2014

Confirmed exhibitors as of July 23, 2013. For the latest list visit www.mediplasuk.com/sessions.html.