MPN EU Issue 16 by MPN Magazine

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MEDICAL PLASTICS NEWS

MICRO 3D-MIDS: A SMALL PART FOR MAN, A GIANT LEAP FOR MANKIND ALSO IN THIS ISSUE: Arburg 3D Printer, Nobody Saw That Coming Packaging: Thermoforming, Fluid Bags, Blow Moulding The Effect Of The Euro Crisis on Irish Medtech The Story Of Endexo Anti-Thrombogenic Thermoplastic Additives

ISSUE 15 November-December 2013 WWW.MEDICALPLASTICSNEWS.COM

Part inspiration. Part insight. Take a closer look at how Eastman Tritan™ copolyester helps create successful medical devices. www.eastman.com/medical

Eastman TRITAN™ copolyester Eastman, Tritan and The results of Insight are trademarks of Eastman Chemical Company. © Eastman Chemical Company, 2013.

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All Medical, All Plastics

Contents

Arburg’s 3D Printer—Page 6

5. Editor’s Letter: Takeover target Sam Anson discusses whether multinational medical device OEMs should consider materials manufacturers as potential acquisition targets. 6. On the Pulse: 3D printing at K K takes place just once every three years and Arburg certainly made a splash in 2013 by unveiling an revolutionary additive manufacturing machine which can process two types of regular polymer pellets at the same time.

Packaging—page 12-29

Form-fill-seal (FFS)—page 24

10. Cover: Giant steps in micro parts Accumold’s Aaron Johnson on converging micro moulding technologies like laser direct structuring (LDS) and micro structure enhancements (MSE). 12. Product Focus: Packaging A bumper spotlight on plastics in medical packaging, including plug assists in thermoformed trays, anticounterfeiting, fluid bags, blow-fillseal (BFS) and form-fill-seal (FFS), and machinery and TPEs for blow moulding. 28. Folio: Cryoblation The Medtronic Arctic Front Advance (trademarked) Cryoballoon placed in the left superior inferior pulmonary vein. The balloon uses cryoablation, a freezing process, to destroy diseased tissue.

Ireland is winning—page 34-41 3D printing in prototyping—page 46

30. Materials: Porous plastics UK manufacturer Porvair tells the story of sintered porous plastic—the evolution from industrial applications to the Chromotrap chip assay test kit.

32. Product Focus: Renal care Eastman’s insight into how Tritan copolyester meets the requirements of modern diaylyser housings. 34. Country Report: Ireland After a tour organised by Med in Ireland, Sam Anson finds out about the effects of the Euro crisis on medical device players. 40. 2013 Review: Highs and lows Mark Bonifacio reveals highlights of what will be looked back on as a landmark year in medical devices. 42. Regulation Review: Navigating risk Styrolution talks making life easier from a risk perspective. The US plastics industry association gives details of how they help their members navigate the regulatory landscape. 46. Design 4 Life: 3D printing Styrenics to play “major role” in 3D printing, and how a team of mountain biking enthusiasts prototyped an advanced knee protector using Stratasys machinery. 50. Doctor’s Note: Polymer hybrids Prof Simon Donell, orthopaedic surgeon, provides an account of a voluntary initiative which goes beyond normal regulatory approvals for monitoring hip and knee replacements. 52. Additives: The story of Endexo The story of Endexo anti-thrombogenic additives for thermoplastic polymers. 54. Events: IMDA, human factors

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Medical Plastics News is available online at our brand new website www.medicalplasticsnews.com and via a digital edition. NOVEMBER-DECEMBER 2013 / MPN /3

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EDITOR’S LETTER

TAKEOVER TALK: Should Multinational OEMs Consider Specialty Polymer Firms as Acquisition Targets?

f you asked a sample of medical device manufacturers what the most obvious industry trend was right now, there’s a good chance that supply chain consolidation would feature on most responses. A lot of recent merger and acquisition activity has been OEMs buying other OEMs. The range includes large purchases—for example the sale of Bausch & Lomb to Valeant and Gambro to Baxter—and small, with countless examples of smaller deals being announced daily. Also, activity has been bouyant in the outsourcing sector, for example the acquisition of RIWISA by Flextronics in August 2013, Nypro by Jabil in July of that year, and the merger between Phillips and Medisize in 2012. But what of manufacturers looking upstream to buy specialty materials expertise? I dropped the question out to my editorial contacts. The responses, as usual, are very enlightening. Former Baxter scientist Len Czuba, based in Lombard, a town just outside of Chicago in Illinois, USA, provides a helpful example. “In the early 2000s, Boston Scientific bought Guidant and as part of the deal they acquired a small polymer manufacturing operation that was making a unique elastomer,” Len recounts. He adds: “The elastomer was developed to be used on drug eluting stents (DES), a product evolution that was recently introduced to compete with bare metal stents. The elastomer was used to coat the nitinol stent into which the drug was imbibed (there are micropores in the metal that are filled with the drug medication).” He goes on to say: “In use, the drug slowly elutes or comes out of the metal but only because the stents are coated with the elastomer which acts as a rate limiter in the elution. I mention this example because at a speech in 2005, the then CEO of Boston Scientific stated that the real jewel of the acquisition of Guidant was the small polymer manufacturing operation that gave them captive use of the polymer for their line of stents. Now almost ten years later, the value of DES products is unquestionably a big part of the the cardiovascular industry and will soon be challenged by the emerging bioresorbables.” Len explains the advantages gained by Boston Scientific: “In the example above the polymer manufacturing operation is very small and even though millions of the stents have been made, each one only contains grams of the polymer. So there is not a big volume of polymer needed. But in the early 2000s, just after the “dark ages” of polymer availability for implants when virtually all the major manufacturers of polymers were running from

implantables, blood and tissue contact and then many other medical device applications, Boston Scientific was happy to control their own destiny with the polymer plant they owned and could use for their supply.” Another respondent, Dr Jim Rancourt, CEO and founder of Polymer Solutions, a US independent chemical analysis and physical testing lab, sees more value in OEMs being served by licensing and consultancy. He explains: “If a unique type of polymer is needed to enable a specialised medical device, the OEM may want to obtain a license to the technology. The OEM does not need to own the entire polymer production process, equipment and expertise if their needs can be met by a client.” George Cheynet, also of Polymer Solutions (he’s the director of sales), suggests an alternative viewpoint. He believes it would make more sense for contract manufacturers rather than OEMs to make these acquisitions in order to offer materials development. He says: “Contract manufacturers who provide materials development services would be able to offer truly one-stop services for the OEM and thus, enhanced value and service. This would align well with the strength of contracts and purchasing within OEMs and reduce their burden of managing vendors.” Steve Duckworth of Clariant Masterbatches business unit adds another interesting angle. He said: “It is clear from our experience there are gaps about polymer materials and modifications of polymers, I would see that an OEM would gain quite a few advantages by an up-stream acquisition However, the problem is I don’t think they know what they don’t know, and probably not the questions they need to ask. This is not to disparage them, but the specialised and practical knowledge is not something taught or learnt in schools and colleges, and tends to be built by experience of encountering problems and learning how to fix them. This is why the tendency in medical devices and pharmaceutical packaging material selection tends to be on ‘what worked in the past’, and this loses many opportunities.” Building on George’s comment about contract manufacturers, Steve adds insight from the electronics industry: “You can think about backward integrations, for example a device manufacturer deciding to buy a compounder of polymers. There are examples of contract manufacturing companies in electronics having their own compounding in-house such as Foxconn. However, unlike Foxconn and the electronics industry, it is unlikely that a medical device producer would consume the volumes produced in a compounding plant.”

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NOVEMBER-DECEMBER 2013 / MPN /5

K Review: Arburg 3D Printer—Nobody Saw That Coming by Sam Anson

hen I saw Arburg’s press conference invitation before the show I knew they had something up their sleeve. I have to admit, I did think to myself “I’ve seen curtains and suspense before, and been disappointed”. The cynic in me thought “Oh, probably just another moulding machine”. A fellow onlooker said, “Have they launched a tie-bar-less machine?”. I responded: “Probably a bigger or faster all electric?” But when the curtain came down, accompanied with digital screens, music and a gymnast chosen to reflect the machine’s flexibility—all of which were more at home at a rock concert than a plastics trade show—I got the feeling people were thinking “I don’t know what that it is but it looks pretty cool.” The Freeformer is Arburg’s offering of a patented additive manufacturing machine. They are talking of it being “a new era” in plastics processing. And it was by far the main talking point of the K show in Düsseldorf in October. Fed by granulate and claiming significantly reduced material costs compared with existing additive manufacturing machine suppliers— they do away with cartridges and filaments, thereby saving the cost of processing these from granulates—to the uninitiated in additive manufacturing the machine looks to offer much promise from technical and commercial standpoints. Technically, Arburg are talking about the potential to process more materials, colours,

compounds—or more generally engineered plastics. The machine also seems to be capable of running multi-material parts. This process works with a tow nozzle, no purging in between is needed. The panel presenting at the press conference specifically mentioned elastomers, polycarbonate and a wide gamut of colours. Responding to a question from yours truly, “Colours are not a problem,” one of the panel said. “We are also working with high temperatures, although we have done less investigation here”, the panel member added. Don’t forget, Arburg are experts in moulding of silicones and powdered metals too. So there may be scope for development in these materials as well. My only other experience of a large supplier to the plastics processing sector moving into additive manufacturing is with US engineering materials manufacturer PolyOne, who announced work with leading additive manufacturing firm RP+M some months back. PolyOne have some of the best know-how in developing custom engineered materials for specific performance applications. At the recent TCT show in Birmingham, UK, one of the world’s most important trade shows dedicated to additive manufacturing, I was fortunate to speak to two experts in additive manufacturing who were using the technology to produce high coloured plastic puzzles. The message from them was clear. “We suffer from a limited supply of materials, especially where colours are concerned. Shrinkage is

October 15, 2013 Arburg Launches Patented Additive Manufacturing Technology

September 29, 2013 Bisphenol A is Safe

“An average adult consumer would have to ingest more than 600 kg of food and beverages in contact with polycarbonate containers every day to exceed the daily intake limit of 0.05 mg per kg of body weight—which is impossible,” said Jasmin Bird, BPA spokesperson of Plastics Europe.

unpredictable, which means we waste approximately 50% of our plastic, and that is expensive and time consuming.” An expert in colorants and additives was party to the conversation: “Different colorants will cause major differences in shear rate and ultimately shrinkage. The difference between yellow and red may cause a change in shrinkage factor of 12% dimensionally.” Arburg seems to have these issues covered, or so they say. But the jury will certainly be out, especially as far as the established additive manufacturing suppliers and users are concerned. Commercially, people are saying that the very fact Arburg have taken this step could be a “game changer”. With a turnover of approaching Euro500 mn in their latest financial year, and with competitors Engel and KraussMaffei pushing close to Euro900 mn each, the potential reach to new users looking for production parts is vast. Commenting on the Arbrug move, James Woodcock, group editor of authority additive manufacturing magazine TCT—which has been in circulation for 20 years—said: “The fact that a large established manufacturing company such as Arburg has entered the additive manufacturing market is unprecedented and of huge interest to the wider additive manufacturing and 3D printing community. There has been much speculation about a large machine tool company entering the market but the rumours always centred around the metals

“The current install base of Arburg’s traditional processing technologies not only dwarfs the install base of any dedicated additive manufacturing machine maker, but also the entire base of industrial additive manufacturing machines. This opens up a truly significant new market to the possibilities of additive manufacturing and could be part of a catalyst that drives industrial applications into the manufacturing mainstream,” said James Woodcock, editor of UK-based additive manufacturing and 3D printing magazine TCT.

October 18, 2013 Dow Launches Game Changing PP-based Olefin Block Copolymer

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“INTUNE PP-based OBCs enable the creation of unique solutions that display the most desired mechanical, chemical and optical properties of PP with PE, POEs and polar materials, fundamentally changing the way the industry thinks about combining polar and non-polar polymers,” said Karen Fennessy-Ketola, global director, new business development, Dow Elastomers, Electrical & Telecommunications.

October 23, 2013 European Medical Device Industries Welcome EU Regulatory Improvements

“The Parliament has voted for many improvements that will effectively improve patient safety. We believe that this paves the way for further needed improvements to be discussed with the Council,” said Eucomed Chief Executive Officer Serge Bernasconi.

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Questions from a 3D Printing Expert Medical Plastics News asked Kevin Quigley of Quigley Design, a UK product design agency established in 1990, to raise some questions about the Freeformer. Arburg’s responses are below. 1. What is the maximum size of part that can be built? The maximum component size—height x width x depth—is 230 x 135 x 250 mm (9” x 5.3” x 9.8”). 2. What is the resolution and accuracy in terms of layer height and repeatability? The layer height varies depending on the nozzle used (0.15 / 0.2 or 0.25 mm) between 0.19 and 0.33 mm. The absolute component precision is +/- 0.15 mm (in X and Y direction). All specifications are based on ABS. 3. Does it use standard commodity materials that a moulder would already have in stock? What materials can it handle? Yes, that is something unique of the Freeformer: It processes standard—and therefore cheap— plastics granulates such as ABS, PC, PA or TPE. Further materials are possible, depending on the

process parameters, and will be specified together with the customers. 4. What is the control system/software used—does it take standard STL or direct from CAD as native formats or generic STEP/IGES? The parameters required for the comprehensive construction of the parts are generated using the in-house-developed Freeformer control system. This receives the 3D CAD data for the components to be manufactured in the form of STL files, processes it automatically through slicing, and production can start. No special programming, processing knowledge or extensive training is required. The gesture-controlled multitouch screen makes easy working with the machine. Arburg follows strictly the same approach as with its injection moulding machines, making complex technology simple to use and developing it in-house. 5. What build speeds are achievable? The discharge volume varies from 5 cm3/h (0.15 mm nozzle) to 21 cm3/h (0.25 mm nozzle). Please note that the Freeformer offers also the opportunity to manufacture two-component parts (with two nozzles).

6. How does the “no supports” build method work for a complex part (think block with tubes coming out horizontally at an angle with big overhangs)? Considering the additive manufacturing process, Arburg has re-thought the principle of moving and stationary machine components. In the Freeformer, the discharge unit remains with its nozzle precisely in a fixed vertical position. The component carrier moves instead. In addition to a standard component carrier that can move along three axes, a version with five axes is available, for example for implementing undercuts without the need for a support structure. The major advantage of the 5-axis version is that support structures of the type required in many other additive manufacturing processes are generally superfluous. 7. How much is it? Where can we see one in the UK? The price will be similar to other high-level machines in the market. However, as you can use standard materials, the running costs are minimal. The Freeformer was exhibited at the Euromold trade fair in December in Frankfurt, Germany.

European Medical Device Industries Welcome European Parliament Improvements on Proposed Regulations Eucomed, the European medical technology industry association, welcomes the majority of measures adopted in October in a plenary vote by the European Parliament on the revision of the EU Medical Devices Directive (MDD). Members of the European Parliament (MEPs) voted for much-needed measures to improve Europe’s notified body system, increase the transparency and traceability of medical devices, introduce unannounced site visits and provide for better stakeholder involvement. In November, there was a shock result from the PIP breast implant trial in France whereby notified body TÜV Rhineland was ordered to pay damages. On the approval system for medical devices, Eucomed positively notes that Parliament has shifted the approach and direction to a more manageable process without compromising the shared goal of improving patient safety. On the reprocessing of single-use medical devices, by adopting a variety of different elements, some newly introduced at Plenary, the approach taken still leaves significant concerns for patient safety as well as legal inconsistencies. For example, reprocessors are not subject to any conformity assessment. This seems at odds with the European Parliament’s stated desire to install a high level of patient safety

8/ MPN /NOVEMBER-DECEMBER 2013

throughout Europe. All in all, Eucomed believes that this vote will send a strong signal towards Council that Parliament is interested in finding a balanced, implementable solution that guarantees both better patient safety and a vibrant and innovative medtech sector. Many measures pave the way to effectively improve the safety for patients and are fully supported by industry. Eucomed now believes that Council and Parliament can concentrate on further improvements, in particular on the medical device approval system, re-processing of medical devices, appropriate clinical requirements and a sensible and scientific approach to hazardous substances. Industry holds the opinion that the Parliament has improved some very essential elements of the approval system, such as clarifying roles and responsibilities of authorities, the Medical Device Co-ordination Group (MDCG), and clinical experts; ensuring Member States authorities are managing the ‘scrutiny’ system, introducing the concept of utilising a small group from a pool of independent scientific experts to support the MDCG in their decision making and installing high-level expertise and quality amongst notified bodies. Eucomed believes that further improvements in the discussions with

Council should look at building the scrutiny process into the upgraded notified body approval system and not adding it on top of or afterwards which would double or even triple the level of bureaucracy in an already improved system. Also, the scrutiny should avoid any sort of cherry-picking or random ‘needle-in-the-haystack’ approach. Eucomed also listened with interest to Commissioner Mimica’s comment in Plenary that after trust in the quality and competence in notified bodies has been built, a move could be feasible from a pre-market product scrutiny to a postmarket system scrutiny based on post market controls.

<< MEPs have voted for measures to improve Europe’s notified body system, increase the transparency and traceability of medical devices, introduce unannounced site visits and provide for better stakeholder involvement. >>

European Parliament Briefed on Contributions of Plastics to Quality of Life, Innovation and Environment Plastics Industry to Play Key Role in Negotiations for Transatlantic Trade and Investment Partnership

ith an eye toward the proposed US-EU free trade agreement, known as the Transatlantic Trade and Investment Partnership (TTIP), plastics industry leaders from the USA and the EU have made an educational presentation to members of the European Parliament and their staffs describing the contributions of plastics toward improving quality of life, sustainability and the environment. The plastics industry is a major factor in the economies of both the US and the EU, and is certain to play an important role in the recently delayed but still ongoing negotiations for the TTIP. “There has always been a strong economic case for a transatlantic trade deal,” said Michael Taylor, senior director, international affairs and trade for USA-based SPI: The Plastics Industry Trade Association. “But at this point in time the argument in favour is even more compelling. While it is true that the US plastics industry stands to benefit greatly

from improved market access to Europe, SPI member companies are very focused on the millions of dollars that can be saved by achieving regulatory coherence and mutual recognition of standards. This will lower the bar for market entry for both the EU and the US.” The presentation to the EU Parliament was co-organised by Amcham Belgium (the American Chamber of Commerce in Belgium) and Assocomaplast (the Italian Plastics and Rubber Processing, Machinery and Moulds Manufacturing Association). The presentation included a pitch of why plastics are the “true resource champions”, by conserving more resources than they use while offering easy recyclability. Also on the agenda was why plastics, due to their ability to be tailored to the specifics of new products, will continue to enable more innovative applications that will add to quality of life.

The presentation featured three speakers from SPI-member companies: l Werner Van De Sande, business manager of Milliken Chemical in Europe. USAbased Milliken Chemical is a developer and manufacturer of performance additives, polymeric colorants, industrial specialties, and processing aids that improve the appearance, performance and productivity of plastics products and processes; l Paolo Gasparotto, branch sales manager for Moretto Plastics Automation, an Italybased supplier of polymer raw material drying and conveying equipment; and l Mark Daniels, senior vice president of sustainability and environmental policy for Hilex Poly, a leading US maker of plastic bag and film products with production facilities in seven states and operator of the largest closed loop plastic bag recycling facility in the world.

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NOVEMBER-DECEMBER 2013 / MPN /9

3D-MIDs | A SMALL PART FOR MAN, A GIANT LEAP FOR MANKIND

Converging Technologies to Solve Problems by Aaron Johnson, Technical Marketing Leader at Accumold

here are, without question, many challenges facing today’s medical device manufacturers. From the regulations to the taxes, there are countless ways a project can stall. Chief on that list is usually a design issue of some sort. Many new product developments or improvements manage to ultimately be some sort of a design constraint.

s are a PC/ABS uare plated part << These 5 mm sq rned on all six g design is patte blend. The platin erlay. >> er/nickel/gold ov sides with a copp

The path to solving one’s challenges can frequently create others. Whether it’s the desire to deliver medicine to remote parts of the body or an effort to reduce the recovery time of a procedure, the constraints are more often not the limit of ideas but the limits of technology. So what do you do if the technology is not readily available for the problem you have to solve? Think outside the box Cliché as it may be, sometimes the answers to our problems are already in front of us, we just need to see them differently. Think of the microwave oven. There’s a reason it used to be called the “radar range”. Someone decided the RF energy coming off of a radar microwave antenna could be captured and controlled to form a brand new way of cooking. The RF communications technology wasn’t new, it was just somebody’s new way of looking at the technology. In terms of manufacturing one of the most enabling technologies over the last several years has been the introduction of micro moulding into the mainstream world of design and development. It’s no secret things are still getting smaller and it’s been micro moulding as one of the key enablers leading the way. The ability to mould thermoplastic parts and components with incredibly tight tolerances, minuscule features or overall part size measured in only a few microns had spurred on new and better designs all across the board. It’s not just about small devices either. Micro moulding and micro technology has also allowed things to get bigger. Think of the large screen television that hangs on your wall at home. It wasn’t that long ago when one could barely lift a 29” television by one’s self, let alone hang it on the wall like a piece artwork. To help us take a different look at manufacturing there are a couple of converging technologies that when combined with micro moulding could bring new solutions to the market. One is laser direct structuring (LDS) and the other is micro structure enhancements (MSE). Laser direct structuring, 3D-MIDs and micro moulding Laser direct structuring, or 3D-MID (micro interconnect device) as it’s often called, is a sophisticated process of selectively plating plastic parts with metal. In simple terms, a laser traces a pattern on the surface of a moulded plastic part and wherever the laser hits the plastic the plating sticks. The base thermoplastic resin comes blended with a proprietary additive that when struck by the laser allows the metal plating to adhere to the plastic. Moulded parts are placed in the laser system and the desired trace pattern is formed on the surface of the plastic. Parts are then rotated if the pattern requires traces on other sides of the component. This plateable additive is available in a wide variety of thermoplastics such as PC, PC/ABS, PBT, PPA or LCP to name a few.

10/ MPN /NOVEMBER-DECEMBER 2013

<< This polycarbonate moulded part consists of 3D micro features measured down to a few microns. The features demostrate a variety of applications from diffractive optics to micro fluidics. >>

The metallisation process begins with an electroless copper bath that then can be top plated with other metals. Gold, nickel and aluminum are just a couple of the plating options. Plated thicknesses are determined by the depth of the laser treatment and the exact procedures in the plating process. The end result is a combined plastic moulded part and metal plated pattern and can be designed to be compliant with SMT, or surface mount technology, a method for producing electronic circuits. Where this technology has a real advantage compared with traditional over-moulded metal is in the geometry. Because the plating can stick wherever the laser can hit, the patterns can take on dimensions that could not otherwise be achieved with a metal insert in the mould. Meaning, the laser can trace on non-flat surfaces, around corners, and even through the parts. Hence the idea of a three-dimensional micro interconnect device (3D-MID). Now think of this in terms of micro moulding. If you could design a part that needed to be really small and needed an interconnect transport of sorts, what would these combined technologies do for the size, weight or functionally of a device? You could design these components in ways never capable with the traditional methods, and with an extremely small form factor. There are some limitations however. Not all of the blended materials react the same. Some, like the PC/ABS compound, will take tightly pitched traces and leave a very fine and cleanly plated path. Others, because of the natural surface of the resin

COVER STORY

<< This whitelight interfrometer measurement screencapture from a Zygo optical metrology application shows the smallest aspherical structure is measured at a 25 μm diameter and 1 μm tall. >>

and its reaction to the laser, cause the plating to splay somewhat, therefore not allowing the traces to be as clean or as close. The LDS process isn’t necessarily a cost or time reduction technology either, it’s more about where it can take your design creatively beyond the physical limitations of over-moulding or insert moulding. The lasering process can be timely, especially the more traces you have and/or the number of sides the laser needs to pass. The plating process also adds a layer of complexity and the different plating options can also be costly. There is another a two-component plating option as well that doesn’t require the laser treatment step. With this process, the blended material is used with a two-shot injection moulding method that wherever the plateable material is exposed from the second shot it can be treated and then plated. Thus, only the exposed portion of the blended material will plate, leaving the second shot material un-plated. Micro structure enhancements (MSE) micro moulding Micro structure enhancements, or MSE micro moulding, is another converging technology enabling new design options for micro plastic parts. With this technology micro sub-structures can be formed on the surface of plastic components. The process can allow micron or sub-micron sized features that can serve a variety of applications from optics to microfluidics. Here again, when combined with micro moulding, it can open a whole new realm of possibilities. The process in and of itself is fairly simple. It boils down to the tool making process for injection moulding. It’s a way of making the tooling so that the micro structures can be formed and replicated on the plastic. In many cases these features are difficult to form using traditional machining techniques and therefore require a different approach to mould making. There are several different techniques one could use to achieve the desired outcome and in most cases is fairly superfluous to the end result. One technique uses a process that is more traditionally found in forming glass photomasks for the electronics industry. This same photoresist technique can be used for imaging a 3D micro structure that then can be nickel plated and used for moulding. Another process uses a similar lithography technique to form the sub-structures on fuse silica that are also directly used in the moulding process. These types of technologies are capable of replicating

extremely small features with a high repeatability. Applications like diffractive optics, micro lens arrays, microfluidics or micro-patterning are just a few examples of what’s possible. When combined with micro moulding this technique can drive miniaturisation to new heights. MSE micro moulding is technically capable of replicating on any thermoplastic, however the natural surface finish or abrasiveness of some materials can limit the ability for the micro images to be replicated to the plastic. For example, a 30% glass-filled LCP can cause micro scratches on the surface of these delicate inserts. If the micro image design has sub-micron sized features they can be destroyed in the moulding process. On the other hand a material like polycarbonate can easily reproduce the tiny features time and again. There are also some design limitations as well. Because of the techniques used to create the micro structures, the moulding is best when limited to flat surfaces. While the MSE micro moulding itself can replicate 3D structures, the moulding tends to be best when kept flat. The tooling process is time consuming and can require a significant investment as well. Other converging concepts Outside these two examples of converging technologies, there are several other ways one could think outside the box when approaching their next design challenge. In some cases, it only requires a slightly different look at the project. Combining what was once multiple parts into one component can advance a multitude of manufacturing solutions. For example, at one point in the development of fibre optic connectors the process required a lens barrel, a glass ball lens and some glue. Eventually the product evolved and it was determined there was no reason the barrel and the lens had to be different materials. Consequently the entire lens and barrel were moulded as one single form factor. Advancements in moulding and evaluating non-traditional material options for lenses, for example polyetherimide (PEI), a common brand of which is Ultem, totally transformed the product development. Today, this same idea has evolved into all sorts of innovative designs like multi-lens arrays, diffractive optics, and imaging devices. Another example is over-moulding. There are many different non-traditional materials that can be over-moulded. Mediums such as fabric, glass, flex-circuits are just a few examples of exotic applications. Generally speaking, anything that can withstand the temperatures and pressures of injection moulding can be overmoulded. It just may take an innovative approach to achieve the desired outcome. Summary As you approach your next design challenge think about what a different perspective may do for the solution. A return to the cliché may just be the ticket. Search out the non-traditional solutions and, who knows, you could create the next big advancement in manufacturing and product development.

NOVEMBER-DECEMBER 2013 / MPN /11

Thermoformed Trays: HOW PLUG ASSISTS PLAY A CRUCIAL ROLE IN PACKAGE DESIGN, MATERIAL DISTRIBUTION AND PRODUCT SAFETY By Noel Tessier, Senior Materials Engineer, CMT Materials When it comes to medical plastic packaging, device manufacturers rarely have the option to rank safety, compliance, performance, cost and quality in order of importance. For most, each of these elements is equally important. Whether you are working with rigid thermoformed trays, form/fill/seal trays or flexible pouches, the same rules apply. In this article, we will focus on thermoformed trays and how plug assists play a crucial role in package design, material distribution and product safety. Plug assist technology allows plastics processors to reduce starting gauge, reduce cycle times and improve material distribution. There are different types of plug assist material, each with their own benefits (see Table 1). Syntactic foam plug assists are purposeengineered for thermoforming and provide unique properties that result in superior packaging. There are several key pre-requisites for any thermoformed tray in medical device packaging including rigidity and clarity. Features such as impact resistance and ease of de-nesting (the ability to stack, or ‘nest’, one tray on top of another without sticking) are also considered. Material selection, therefore, is of primary importance. Certified, medical grade films made from HDPE, PP, PS and PETG are the most commonly used materials in thermoformed medical packaging. Each material type has its own characteristics and sheet suppliers generally provide the 12/ MPN /NOVEMBER-DECEMBER 2013

appropriate documentation outlining specific properties including specific gravity, tensile strength and, perhaps most importantly, thermoforming temperature. Heating and Cooling the Sheet Best practice suggests that the temperature of the plastic sheet should be measured to ensure the optimal forming window. New data-driven technologies are being integrated with thermoforming systems that allow processors to dial in very specific measurements. Generally speaking, the goal is to keep the heat in the sheet right up to the point where the plastic enters the tooling cavity. This is where the plug assist becomes part of the equation. The plug is designed to pre-stretch the material into the right place at the right time. Doing so adds a level of predictability to a process that is notoriously filled with variables. Let’s look at two such variables as they relate to the plug: thermal conductivity and the coefficient of thermal expansion. Thermal Conductivity Thermal conductivity refers to the quantity of heat that passes in a unit of time through a unit of area when its opposite faces differ by a unit of temperature (BTU/hr-ft-°F). In this case, we are talking about BTUs as the quantity of heat that passes in an hour in a foot for every degree of temperature difference between the plug and the sheet. A high number either means the plug will quickly freeze the sheet or

PACKAGING

<< LEFT | PTFE-impregnated plug assists help to pre-stretch material into trays with undercuts or snap features while allowing for greater release from the plastic sheet. >> Category Historical / traditional

Traditional solid polymers

High performance solid polymers

Engineered plug assist

Material

Pros

Cons

Wood

Good insulator

Durability / dimensional stability

Felt

Ease in machining

Mark-off / part repeatability

Foam / felt covered forms

Low cost

Temp resistance

Aluminum

Temp / process control

Durability

Increased cycle time

Surface characteristics

Process cost

Delrin

Cost and availability

Poor durability / dimensional stability

Nylon

Ease in machining / toughness

Poor insulators

Urethane

Surface characteristics

Temp resistance

Polysulfone

Improved temp resistance

Poor durability / micro-cracking / crazing

PEI

Toughness / strength

Poor insulators

Surface characteristics

High cost

Excellent insulator

Learning curve for use

Ease in machining

Initial cost

Surface finish choices

Many choices

Syntactic foam

Durable << Table 1: Categories of plug assist materials with comparative benefits. >> that it must be heated/cooled with an outside means to match the sheet temperature. This is logical, but it adds cost and complexity while increasing the cycle time. It is also the case that air flow and ambient conditions can vary, which reduces consistency. Most processors choose a plug with very low thermal conductivity simply because it does not remove heat or chill the sheet under any conditions. The lower the conductivity number, the less impact it has on the sheet. Coefficient of Thermal Expansion The coefficient of thermal expansion (CTE) is the amount of expansion (or contraction) per unit length of a material resulting from a one degree change in temperature. In simplest and most practical terms for the thermoformer, it can be thought of as how much a material will grow when its temperature increases. In English units it is typically expressed in length/length/per degree Fahrenheit (in/in/°F). In metric, it is m/m/°C. Syntactic foams are filled with hollow glass spheres, so even though they are polymeric in nature, the stable fillers mean that the CTE is relatively low, around 20-30 x 10-6 in/in/°F. When you couple this with the fact that syntactics are excellent insulators and therefore take less heat from the sheet and run at much lower operating temperatures, you have a material that maintains a much higher dimensional stability than other plug material types. By way of comparison, Delrin has a CTE

of 59 x 10-6 in/in/°F. Nylon can range from 4060 x 10-6 in/in/°F. This means they grow and change greatly during the process as they absorb heat from the sheet during contact. With more stable materials, the thermoforming process itself becomes much more stable, providing for a greater degree of consistency and repeatability. Plug Geometry, Plug Material and Package Design When it comes to package design, form and function must be balanced. Design engineers use state-of-the-art software to create innovative and eye-catching packages while still maintaining the fundamental goal of protecting and displaying the product inside. Syntactic foam plug assists aid in the design process by pre-stretching the sheet into position without removing heat or affecting its formability. This is critical because the design work is based on material specifications which are based on specific, optimal sheet forming temperatures. Overheating a sheet is often the cause of loss of plastic orientation, lower strength, loss of clarity, sheet sticking to the plug and a wide range of uncontrolled issues, all due to compensation for a plug that chilled the sheet on contact. It is important to understand the interplay of the plug material, plug geometry, tool design and sheet temperature, and not just to look at each element in isolation. Surface friction, roughness and temperature are all in play. To

control the interaction between plug and sheet requires the ability to modulate release. Doing so reduces variability and increases repeatability. Testing and Validation of Specific Plug Materials CMT Materials of Attleboro, Massachusetts, USA, and RPC Cobelplast of Lokeren, Belgium, performed tests to develop optimal plug materials for multilayer barrier films that would be used in both rigid thermoformed trays and form/fill/seal (FFS) applications. RPC Cobelplast is a leader in coextruded, multilayer, high barrier plastic films for the European and international thermoforming market. RPC has a custom-made laboratory thermoforming machine to aid in the development of improved multilayer films for thermoforming. This machine was used to evaluate a range of plug materials in forming multilayer packages from a PE/EVOH/PS coextruded sheet. Two series of different plug materials were evaluated: PTFE, POM, HYTAC-W, HYTACB1X, HYTAC-WFT and HYTAC-FLX. Initial trials showed HYTAC-WFT and -FLX to have the best potential for medical thermoforming applications. Based on these results, CMT went back to the laboratory and developed HYTACFLXT to combine the best performance properties of the two materials. A third set of trials showed HYTAC-FLXT to have the best

Continued on page 15 NOVEMBER-DECEMBER 2013 / MPN /13

PACKAGING

<< BELOW | Shallowdraw thermoformed trays can benefit from plug assists that provide definition in tight areas. >>

<< HYTAC XTL is a tough syntactic, easily machined for precise detail with a smooth surface that can be polished. >>

Continued from page 13 forming and release characteristics of all the plug materials in multilayer applications with EVOH. A final series of trials compared RPC’s standard PTFE plug material to HYTAC-FLXT using a starting sheet of 1.4 mm thickness of PE/EVOH/PS. The team looked at optimised plug geometry for PTFE as well as several process variables developed for the PTFE plugs and compared them to three different plug geometries for HYTAC-FLXT and process changes to determine the best conditions for HYTAC-FLXT. Figure 1 compares the thicknesses for the multilayer with EVOH container formed with the standard PTFE with HYTAC-FLXT. Material distribution was much more consistent with HYTAC-FLXT versus the PTFE. Additionally, the minimum wall thickness with the standard plug material was 128 microns versus a minimum of 188 microns for the HYTAC-FLXT plug. This increase in minimum wall thickness allowed RPC to down gauge the starting

multilayer thickness by approximately 10%. Sustainability and the Bottom Line(s) Reducing the starting gauge of the plastic sheet is a well-known reason to use plug assists, but the benefits extend beyond the package. Using less material through down-gauging (or light-weighting) has important environmental benefits. When considered in the context of millions of packages produced each year, the numbers can drive change at the top levels of major device manufacturers, especially those public companies with prominent commitments to sustainability. Whether it’s due to ESG reporting (environmental, social and governance) or CSR requirements (corporate social responsibility), businesses are seeing how innovations in packaging not only result in a lighter environmental footprint, but also in tangible cost savings (reference Medical

Effect of Plug Assist Material on Thickness of Thermoformed Multilayer Container (PE/EVOH/PS) 500

<< Figure 1: Comparative sheet thickness with two different types of plug assist material, HYTAC FLXT and PTFE. >>

Value Thickness (microns)

375

250

125

Packaging Innovation see http://bit.ly/1b03bcK). The judicious use of plug materials and of plug assist techniques have proven to reduce material thickness without compromising the quality and integrity of the package. That’s a double-bottom line worthy of notice from the design lab to the C-suite. Acknowledgements: RPC/CMT study (2009) About the author: Mr Tessier is a materials engineer with over 35 years of experience in the research and development of composite materials and syntactic foams. He is one of the three founding directors of CMT Materials, Inc (1998), the first company to be dedicated to thermoform tooling materials. Author and coauthor of five patents and numerous articles and presentations, Mr Tessier’s impact on thingauge thermoforming can be measured both by the increasing volumes of plastic packaging around the world and more specifically by the adoption and growth of 3rd axis plug-assist forming. He is currently responsible for the development of new and innovative materials at the company.

Points of Measurement FLXT Plug

PTFE Plug

NOVEMBER-DECEMBER 2013 / MPN /15

PACKAGING << The building of the European Directorate for the Quality of Medicines (EDQM) in Strasbourg, France. >> << Susanne Keitel, Director of the European Department for the Quality of Medicines & HealthCare (EDQM), Council of Europe >>

Counterfeit Medical Products: Council of Europe Steps Up Action Worldwide with Medicrime Convention

eventy participants from 32 countries from all continents, member states and observer states of the Council of Europe and observer states of the European Pharmacopoeia Commission met on October 16-17, 2013, in Strasbourg, France, to discuss cooperation in the legal and public health fields so that the Medicrme Convention can rapidly be ratified by as many countries as possible worldwide. The Medicrime convention is a binding international instrument in the criminal law field on counterfeiting of medical products and similar crimes involving threats to public health. In June 2013, about 100 countries participated in a worldwide operation, Pangea VI, aimed at dismantling criminal networks responsible for the illegal online sales of medicines. This operation led to the arrests of 58 persons all over the world. In addition, 10.1 million potentially dangerous, illegal, counterfeit tablets were seized and more than 13,700 websites were closed. The Medicrime convention is intended to fight this phenomenon, promote effective international cooperation and protect patients. This is the first and the only currently available legal instrument that can be used by the international community. Its main advantage is to introduce penal sanctions not only for intentional acts such as “supplying or offering to supply counterfeit medical products” but also for “similar” crimes such as the sale of a product that has not been authorised by the authorities and which is claimed to be effective against a disease. The conference supplemented other initiatives and support provided by the Council of Europe to its member states, a number of which have already started to take the first steps towards ratification. As many as 32 countries participated in the conference—Algeria, Argentina, Austria, Belgium, Cameroun, China, Congo, Croatia, France, Georgia, Guinea, Ireland, Israel, Italy, Japan, Jordan, Luxembourg, Madagascar, Malaysia, Mexico, Moldova, Morocco, the Netherlands, Russia, Senegal, Serbia, Singapore, South Africa, Spain, Switzerland, Tunisia and the United States. To date the convention has been signed by 23 countries. Spain has recently ratified the Convention, thus joining Ukraine. Other countries are expected to ratify the Convention very soon. Context Counterfeiters have unlimited imaginations: under-dosage, modification of the packaging, substandard copies of the active

16/ MPN /NOVEMBER-DECEMBER 2013

ingredient, intentional errors on the source of excipients. No disease is exempt from such trafficking of counterfeit medicines: cancer, AIDS, high blood pressure, diabetes, and so on. The counterfeiting of medical products and related crimes is a growing problem in all regions of the world: l up to 80% of anti-malarials in certain West African countries are substandard1; l more than 300,000 women in 65 countries might have received defective breast implants, including breast cancer patients who have undergone breast reconstruction surgery. A company with headquarters in Europe is now accused of aggravated fraud and endangering lives. Thousands of women are worried about the health implications, and many of them have subsequently had their implants removed2; l a counterfeit anti-cancer medicine was sent from the Middle East to Europe and from there to the United States, via intermediaries. If the shipments had not been intercepted in time, patients would have received ineffective treatment3. References 1 WHO World Malaria Report 2011 &2. Gaurvika, M.,B. Nayyar, J.Breman, P. Newton, and J. Herrington, “Poor-quality anti-malarial drugs in southeast Asia and sub-Saharan Africa”. The Lancet Infectious Diseases. Vol. 12, No 6, pp.488-496, June 2012 2 http://fr.reuters.com/article/topNews /idFRPAE93F0BG20130416 3 http://www.reuters.com/article/2012/04/05 /us-avastin-fake-idUSBRE83407D20120405

<< Snežana SamardžićMarković, Director General of the DG Democracy, Council of Europe >>

Rollprint Creates Ghost Anticounterfeiting Flexible Packaging Technology

<< Ghost anticounterfeiting technology creates an integrated watermark embedded in a flexible material. >>

S packaging materials supplier Rollprint Packaging Products has developed a proprietary new technology for composite flexible packaging materials to support medical device and pharmaceutical company anticounterfeiting efforts. Trademarked Ghost, the technology is a process which creates an integrated, repeating watermark embedded in the composite flexible packaging material making it technically and economically challenging to duplicate. Companies have the flexibility to use corporate logos or other symbology for the easily visible, overt watermark which provides visual confirmation to the user that the products being used are authentic. Ghost is ideally suited for chevron pouches used in medical device applications—such as sutures, scalpels, prefilled syringes, artificial joints, catheters, and so on. The technology can also be used in conjunction with blister packs, packets and packaging for other securitydriven or luxury items. Rollprint, said to be known for developing many packaging “firsts” for medical device and pharmaceutical applications, created Ghost to give companies a viable, cost-effective anticounterfeiting option. The proprietary technology can be used with a variety of material combinations including peelable and weld seal options used in conjunction with polyester, foil, nylon and other substrates. “Companies that are currently using anticounterfeiting measures, typically employ covert options that add significant cost and frequently require specialised equipment,” said Dwane Hahn, vice president of sales and marketing, Rollprint. “Examples include inks which are only visible under UV light and micro printing,” she adds. “Because the watermark is added concurrently during normal processing, we can usually add the feature at little or no additional cost. It’s just one more example of how Rollprint provides value to its customers.” Attempting to duplicate the watermark reportedly requires very specialised equipment with knowledge of proprietary, advanced technology, coupled with significant financial investment.

PRO O EN. E ;MXL EE WWSPI SPI JJSGYW SGYW S ;MXL SR R Q QIHMGEP IHMGEP H HIZMGI IZMGI T TEGOEKMRK EGOEKMRK HIWMKR ERH ERH TVSHYGXMSR TVSHYGXMSR & EVKIV L EW T VSZIR I \TIVMIRGI HIWMKR &EVKIV LEW TVSZIR I\TIVMIRGI MR TVSZMHMRK TVSZMHMRK GVIEXMZI MR GVIEXMZI ERH ERH XIGLRMGEPP] XIGLRMGEPP] MRRSZEXMZI MRRSZEXMZI WSPYXMSRW *VSQ *VSQ H SYFPI WWXIVMPI XIVMPI F EVVMIV XXLIVQSJSVQ LIVQSJSVQ WSPYXMSRW HSYFPI FEVVMIV TEGOEKMRK ERH ERH TVSXIGXMZI TEGOEKMRK TVSXIGXMZI &EVKIV+EVH &EVKIV+EVH® TSYGLIW TSYGLIW XS XS PMH GSRZIVWMSR GSRZIVWMSR ERH ERH QSVI QSVI &EVKIV &EVKIV TVSZMHIW TVSZMHIW IZIV]XLMRK IZIV]XLMRK PMH ]SY RIIH RIIH XS XS QEOI QEOI ]SYV ]SYV TVSHYGX TVSHYGX PEYRGL PEYRGL WYGGIWWJYP WYGGIWWJYP ]SY TRUST BARGER. TRUST

HighHigh-Tech Tech SOL SOLUTIONS UTIONS

High-Touch High-Touch SER SERVICE VICE

ĈĈ -RZSPZIH JVSQ concept ion -RZSPZIH JVSQ concept to complet completion

Ĉ 3ZIV 40 years SJ I\TIVMIRGI years SJ I\TIVMIRGI Ĉ 3ZIV 40

ĈĈ Award-winning IWMKRW Award-winning H HIWMKRW

Ĉ ISO 9001 Certified Certif ied Ĉ ISO

LEARN LE A RN M MORE ORE I IQEMP MRJS$FEVKIV GSQ SV ZMWMX YW SRPMRI bargerpackaging.com QEMP MRJS$FEVKIV GSQ SV ZMWMX YW SRPMRI bargerpackaging.com

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FLUID BAGS

Advantages of New TPEs over PVC IN FILM BAGS AND POUCHES by Ross Van Royen, Senior Medical Market Manager, the Thermoplastic Elastomer Division of Teknor Apex Company

edical-grade PVC film has long been a widely used and trusted material for fluid bags and pouches, and Teknor Apex Company is well established as a supplier of PVC compounds for use by film producers. Increasingly, however, issues such as those focusing on the phthalate plasticisers used to make PVC flexible are causing some film manufacturers—or their customers—to look for alternative materials. Until now the proposed replacements have failed to duplicate the advantages of PVC in terms of cost, properties, or ease of fabrication. New MD-500 Series compounds in the Medalist range of medical thermoplastic elastomers (TPEs) from Teknor Apex promise to provide the first practical alternative to PVC in such applications as: cushioning bladders (for mattresses, wheel chairs, and gurneys); IV and saline bags; medicine storage and delivery pouches; bags for enteral and parenteral nutrition storage and delivery; dialysis bags; and surgical pouches. Bags produced from these compounds (illustration 1 page on 22) are comparable to PVC in processing, assembly, and clinical handling. The difficult bonding issue has been addressed by RF welding, heat welding, and/or new design. At the same time, tests by Teknor Apex and collaborating companies have shown that these TPEs provide a number of property improvements over PVC, along with substantial savings in weight and cost. Properties Superior to PVC Film at Less than Half the Thickness To maximise the potential of Medalist MD-500 compounds as replacements for PVC, Teknor Apex worked with companies having expertise in medical film manufacture and pouch

fabrication. One of these was O’Sullivan Films, based in Winchester, Virginia, USA, a specialist in producing film using the calendering process. Until now, few polymers other than PVC have been used successfully in calendering, but as a result of innovation by Teknor Apex, the Medalist MD-500 Series includes not only extrusion grades but also the first TPE compounds that can be calendered on large production-scale equipment. In comparisons of PVC and TPE films, both produced by calendering, the TPE products exhibited substantial costperformance advantages: l Raw material economy. Even at a little less than half the thickness of PVC (15 mm for PVC versus 7 mm for TPE), film made from TPE exhibited the same degree of physical strength, substantially greater elongation, and significantly greater tear resistance (see table 1). This indicates that TPE can be down-gauged to a considerable degree without compromising strength. l Weight savings. Because the TPE compounds are 30% less dense than flexible PVC and can be made into thinner films, finished products can be 66 to 70% lighter, enabling savings on shipping costs. l Enhanced end-use properties. Even when down-gauged by 54% in comparison with PVC, the TPE film exhibited better moisture and nitrogen barrier and substantially greater low-temperature resistance as measured by a -40 °C cold impact test (table 1). Continued on page 21

<< Table 1: Properties of Class III / Class VI Medical Film: TPE versus PVC >>

SOURCE: O’Sullivan Films

SINGLE-PLYTPE (7 MIL / 0.18 MM)

UNSUPPORTED FILM PVC (15 MIL / 0.38 MM)

19.97 15.31 12.18 5.97 932 997 3.07 3.03

19.37 16.81 8.31 7.36 309 494 1.90 2.03

D-2240

-1.5

3.5

D-1204

10 of 10 pass

0 of 10 pass

D-1790

0.0465

0.1610

E-96

Oxygen permeability, P (CM2/SEC-ATM)

2.30158 E-07

2.25206 E-07

D-1434 (V)

Nitrogen permeability, P (CM2/SEC-ATM)

6.88857 E-09

8.47040 E-09

D-1434 (V)

PROPERTY Tensile strength, MPa 100% modulus, MPa Elongation, % Tear strength ©, MPa

MD CD MD CD MD CD MD CD

Hardness, Shore A (15 sec. dwell) Dimensional stability (MD / 10 min. @ 100 ºC.), % -40 ºC Cold impact (Masland) Moisture vapor transmission - rate, g/h•m2

ASTM TEST METHOD D-882 D-882 D-882 D-1004

NOVEMBER-DECEMBER 2013 / MPN /19

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FLUID BAGS << LEFT | Illustration 1: New technologies make possible medical film products, such as this pouch, that combine the advantages of thermoplastic elastomers (TPEs) over PVC, the quality benefits of calendering, and the sealing efficiency of radio frequency (RF) welding. >>

Continued from page 19 In testing by O’Sullivan Films and an independent medical device designer, the TPE films underwent gamma sterilisation with no colour change. A valuable property of the TPE film cited by O’Sullivan Films is that it is optically clear when filled with a non-opaque solution—important for many clinical applications, especially infusion. This crystal clarity is one of several advantages of Medalist MD-500 Series compounds over traditional TPEs. In addition they are also stronger, provide greater oxygen barrier, are more gamma stable, and have a more PVC-like “feel”. O’Sullivan Films reports that there has been commercial use of its calendered TPE films involving storage of fluids for extended periods of time. In development are applications for infusion and stem cell processing. Research continues on possible use of TPEs for processing of blood components.

<< Illustration 2:The typical calender process. >> The calendering process such as that employed by O’Sullivan Films has long been used for PVC medical films. Indeed, Teknor Apex’s Vinyl Division uses the process to make medical-grade products. In calendering, producers fuse flexible compound and pass it through a series of synchronised nip rolls (see illustration 2). The process yields certain advantages over extrusion, including tighter gauge control, more uniform product, and

<< Illustration 3: Using the established ecoGenesis welding process, it is now possible to switch a PVC media reservoir bag, being mandrel-welded using a Tefloncoated tooling setup, to TPE. >> wider rollstock for higher-volume bag production. O’Sullivan Films produces calendered films in widths up to 84 inches (2.1 m) at an annual output of 80 million lb (36 million kg). RF Welding Now Usable for TPEs as Well as PVC Besides being calendered successfully on large production-scale calendering equipment, an additional breakthrough for TPEs involved another collaborator: Genesis Plastics Welding based in Indianapolis, Indiana, USA. Genesis is a contract manufacturer of medical and other film bags and pouches using the radiofrequency (RF) welding method. While RF welding is widely employed for fabricating bags made of PVC and thermoplastic polyurethane (TPU) elastomer, the process has not been applicable to other thermoplastic elastomers without use of special additives. In light of the versatility of RF welding, this has been a disadvantage for TPEs. Beyond the straight-line bonds produced with standard heat sealing, RF welding can produce bonds in complicated shapes, a wide range of sizes, varied weld widths, and combinations with non-film products such as fabrics or foams. With a well established and trademarked technology called ecoGenesis, which Genesis both employs as a contract manufacturer and licenses to other fabricators, these advantages are now available for TPE films. For example, it is now possible to switch a PVC media reservoir bag, like that shown in illustration 3, being mandrel-welded using a Teflon-coated tooling setup, to TPE. Conventional RF welding works well with “high dielectric loss” or “polar” polymers such as PVC and TPU elastomers. Under the influence of an electromagnetic field, these otherwise electrically neutral polymers tend to align themselves with the field—hence the term “polar”. The styrenic and olefinic polymers used in formulating the less costly, more widely used types of TPE such as those in the Medalist range are non-polar and until now have not been bondable with RF welding. The same has been true for certain polymers to which TPEs might be bonded, such as polypropylene and polyethylene. Continued on page 22 NOVEMBER-DECEMBER 2013 / MPN /21

FLUID BAGS Continued from page 21 The ecoGenesis RF plastics welding technology developed by Genesis enables film produced from a Medalist elastomer to form strong permanent bonds with itself and with polypropylene and similar polymers. Genesis describes this proprietary technology as a “bolt-on” addition to conventional RF welding systems, such as those already widely employed for medical and non-medical applications. For users of the technology, there is no need to invest in alternative capital equipment, and welding of non-polar materials is accomplished without need for plasticisers or other additives that in the past have been used to render such material RF-weldable. With the addition of non-polar materials to the capabilities of RF welding, this process can now be used to heat seal virtually any thermoplastic to itself or in combination with compatible polymers in the form of films, laminates, woven fabrics, nonwovens, and foams. Films as thin as 0.00025 inches (0.006 mm) can be welded. Alternative to PVC and TPU with Advantages over Both Three technological breakthroughs have come together to make Medalist TPEs a strong contender to replace both PVC and TPUs in a range of medical bag and pouch applications: 1) development by Teknor Apex of Medalist formulations with the rheological and thermal properties required for calendering; 2) successful deployment of these novel TPEs by O’Sullivan Films in production of commercial-grade medical films; and 3) Genesis Plastic Welding’s development of an RF-welding innovation that gives TPEs the same advantages as PVC and TPU in bonding and sealing.

22/ MPN /NOVEMBER-DECEMBER 2013

Medalist TPEs can serve as lower-cost alternatives not only to TPUs (which have generally cost more than widely used TPEs based on olefins or styrenics) but also to traditionally lower-cost PVC. At the same time, TPEs exhibit a number of substantial performance benefits over PVC and even some advantages over TPUs. All compounds in the Medalist range contain no phthalates such as DEHP, nor any other plasticisers, and they are free of mineral oils, animal-derived materials, and bisphenol A (BPA). They are compliant with relevant FDA, CONEG, RoHS, REACh, SVHC, and California Proposition 65 directives. Teknor Apex manufactures all Medalist TPEs in ISO13485-certified plants in the USA and the UK. Medalist is a registered trademark of Teknor Apex Company. Teflon is a registered trademark of DuPont and EcoGenesis is a trademark of Genesis Plastics Welding. About the author: Ross Van Royen is senior medical market manager for the Thermoplastic Elastomer Division of Teknor Apex Company. He has been employed by Teknor Apex for over 20 years and held a number of commercial, manufacturing and engineering positions. Prior to Teknor Apex Company he was employed by ENSR Consulting and Engineering. Ross Van Royen has an MBA from Bryant College and a BS in Chemical Engineering from the University of Massachusetts, USA.

FLUID BAGS

Injectable drugs: a long, winding road by Sylvie Ponlot, Technoflex

nce exploratory research and preclinical testing of the molecules have been completed, Phase I clinical trials start with healthy volunteers (50 to 100). The goal is to determine the maximum dose tolerated by man, as well as the administration method. Phase II, peformed on a few hundred people, evaluates the FROM RESEARCH INTO dose-effects relationship, MOLECULES THROUGH TO defines the drug dosage and SALE OF THE END PRODUCT, detects short-term adverse effects. It is also the starting MORE THAN TEN YEARS point for development of the ARE REQUIRED TO DEVELOP primary packaging. In order AN INJECTABLE DRUG. THE to be compatible with the “GESTATION” OF MEDICINES drug and to guarantee IN BAGS INVOLVES FOUR perfect stability, the material used for the bag has to PHASES, AS WITH conform to numerous STANDARD DRUGS, BUT parameters. The aim is to WITH A FEW MORE SPECIFIC avoid any interaction with CONSTRAINTS. the product that may pose a threat to the quality of the TECHNOFLEX, A EUROPEAN injectable drug and hence to LEADER IN DESIGNING AND the patient’s safety. A key point to consider MANUFACTURING IV BAGS is the raw material from AND CONNECTORS, SHINES which the bag is made. This A SPOTLIGHT ON A ROAD material undergoes a study POTENTIALLY FRAUGHT of extractables and WITH PITFALLS. leachables, then an assessment of toxicity and risks. Extractables are compounds of plastics that can be extracted by solvents with physical and chemical properties that differ under aggressive conditions. Leachables refer to compounds that can be released by plastics into the pharmaceutical products under normal conditions of use. At this stage, Technoflex’s R&D department also verifies that compatibility between bag and spout is optimal. Decisions are made about criteria like diameter, whether to have an aseptic filling or not, and so on. Factors other than the composition of the drug can affect the stability of the product in contact with the container. This is the case with ambient temperature and humidity. The stability study carried out also has to take account of low temperatures as well as the freezing/thawing cycles, particularly for biotechnologies and blood derivatives. For certain preparations it is also essential to consider the effects of exposure to light. Phase III could be called the “comparative testing” phase. It is the main clinical trial and includes several thousand people. The drug’s properties are compared with a placebo or an existing drug. Only if an acceptable benefit-risk ratio is proven can a market authorisation (MA) be awarded. At this stage of testing, the injectable’s primary packaging is ready: polypropylene, polyethylene, EVA or PVC depending on the nature of the drug. The final phase starts when the drug is marketed: this is pharmacovigilance. Knowledge of the drug in actual conditions of use is furthered in this way. Phase IV is also called post marketing surveillance. The goal of therapeutic research is to develop high-quality, efficient injectable drugs. It is a long, complex process. The expertise of all the main players is required for innovative treatments to emerge.

<< Jérôme de Monpezat at work at Technoflex. Jérôme is in charge of the development and prototyping of packaging and connectors for IV drugs. >> About the author: Sylvie Ponlot is in charge of communication at Technoflex. She is the editor in chief of Flexmag, the company’s magazine and a passionate photographer who exhibits regularly.

Component diameters to 0.5mm Bore size to 0.1mm Wall thickness down to 0.1mm, even on PTFE! Tolerances to 0.02mm Surface finishes to 0.2Ra Component aspect ratios up to 100:1

NOVEMBER-DECEMBER 2013 / MPN /23

FLUID BAGS and BFS/FSS Melitek Expands Danish Plant: Trends in Polyolefin and Elastomer Compounds segregated production lines to avoid cross contamination. Both films and tubing made from meliflex compounds match PVC in transparency and flexibility and do so without containing DEHP (DOP) or any other plasticiser content. Moreover, they withstand sterilisation at 121°C (394°F), EtO, gamma and E-beam. The polyolefin-based polymers are environmentally sound as they are non-hazardous and easily disposable without concerns of dioxin emissions and hydrogen chloride which have been reported as a concern by some hospitals during the incineration of PVC.

multi-chamber bag made of << An example of a flexible free meliflex compounds. >>

PVC-

<< A film application that matches PVC in transparency and flexibility customised for the healthcare market. >>

anish medical polymer compounding company Melitek has broken ground on a new plant and expects to be in full operation by September 2014 with an additional nominal production capacity of up to 8,000 tons. The new production facility will provide Melitek with about 1,200 sq m (nearly 13,000 sq ft) of additional space, including a new production line which the company says will make the plant even more competitive and efficient. Melitek has experienced a steady growth in demand for its meliflex brand of materials which are olefin based TPE and TPO compounds customised for pharmaceutical packaging and medical devices. “Both new business and organic growth from existing customers prove to us that there is a higher demand for our medical compounds offering eco-friendly plastic solutions in the healthcare market,” says Jesper Laursen, Business Director. The company points out that its meliflex compounds are produced from pure and chemically inert raw materials, are PVC-free and do not contain any phthalate plasticisers. “We have chosen to make a significant investment for the future of our company in order to service coming needs of our customers and to allow for growth into emerging markets”, comments Kim Laursen, Managing Director. He continues: “We are privileged to supply leading healthcare companies and their key converters, hence our investment will guarantee higher flexibility and supply security for our customers, both of which are eminent for medical companies.” “Our expansion shows that we are ready to grow with our valuable customers; grow in new markets and develop new applications for our material technology,” concludes Jesper Laursen. Fluid Bags and Tubing Melitek has a long history in providing non-PVC solutions for flexible films for primary packaging and tubing applications having supplied commercial solutions to the healthcare market for over 15 years. Melitek is therefore one of the suppliers with the longest commercial history in the market for PVC substitutions. Meliflex compounds are used for flexible bags, for example infusion, dialysis and nutrition solutions, and for tubing applications like catheters and drug delivery systems. Materials are tested with independent international test institutes to certify that they comply with medical standards such as ISO10993, USP and European Pharmacopeia. Melitek produces all its polymers under GMP and with a medical service concept which guarantees full lot traceability for 13 years, change control management and extensive line clearance procedures and 24/ MPN /NOVEMBER-DECEMBER 2013

Soft Polypropylene Materials are Gaining Market Shares A trend witnessed by Melitek in the market for medical products during the last 20 years is that clear, phthalate-free TPEs are being used as alternatives to PVC materials. However, Melitek also believe that soft polypropylene compounds (TPO) are going to replace TPEs in some applications. Advantages for soft PP are mainly in regard to an improved regulatory and environmental profile along with an advantageous cost base, making it an even more viable alternative to flexible PVC. Issues with styrene monomer content are also eliminated, something which has been reported as an issue with TPE-S materials. A trend outside the USA is towards blow-fill-seal (BFS) produced containers for standard IV solutions as they offer low cost and high output production. BFS IV-bottles are primarily produced from PE, offering an additive-free packaging material with good impact properties and adequate flexibility. For markets that demand sterilisation at 121°C, the new soft PP materials offer a solution. In several European and emerging markets, the market share of BFS containers for IV solutions outnumbered flexible bags, regardless if these are made from PVC or PVC-free films. This market change from flexible bags to BFS containers for standard IV solutions has lead to an idea that the flexible non-PVC bags today are more focused on high-end applications where special requirements are put on the bags, for example offering multi chamber bags. These trends are also seen in parenteral nutrition (PN) and in peritoneal dialysis (PD) bags as well as for new biotech drugs. This shift has resulted in bespoke customer requirements which are more flexible and serviced by unique customer compounds where critical mass is less of a concern compared with reactor produced materials. Thus the overall technical and regulatory requirement profile for material used for future flexible bags are increasing to satisfy these higher-end applications while customer needs are becoming more diverse. The future growth in the flexible bag market is to a large extent driven by a technology switch from glass bottles to flexible PVC free bags, while BFS containers made from PE or soft PP are gaining its market share from glass bottles, PVC and non-PVC bags.

Profile of a Form-Fill-Seal Machine: Kiefel

An innovative line for the PRODUCTION OF IV BAGS WITH INTEGRATED FILLING

hether you are using thermo-contact or high-frequency welding, or flat or tubular film material, the manufacturing of infusion bags has to fulfil the highest quality standards. Thanks to its newly-developed KFFS (KiefelForm-Fill-Seal) machine, welding-technology specialist Kiefel says it meets the needs of the market to perfection. The KFFS uses thermo-contact welding system manufactures (in 4x configuration) to produce up to 6,000 infusion bags per hour, occupying floor space of just 18 square metres (193 sq ft). The system permits the flexible production of different sizes of IV bag, in 2x, 4x and 6x configuration, along with multi-chamber bags with peel-open seal. The filling unit is integrated into the system. “Highly-precise” dosing technology ensures accurate filling. Oxygen or other gases can be supplied. Monitoring and testing units can be used in accordance with the corresponding application. A printing unit—heat-embossing or laser—can also be added. The KFFS is said to minimise film material waste and with one welding and one cooling cycle it operates with less process cycles compared to other systems. The compact stainless-steel design of the machine meets the requirements of GMP Class C with respect to hygienic purity and space-saving. The machine can also be supplied complete with a cleanroom cabin permanently attached to it. The compact cabin is designed on the principle of turbulent mixed ventilation in accordance with GMP Class C “at rest”, corresponding to class 7 in accordance with ISO 14644-1, and class 10,000 in accordance with US Fed Standard 209e, and GMP Class C “in operation”, corresponding to Class 8 in accordance with ISO 14644-1. In order to create optimum conditions, the integrated pure-air units are operated at an airflow rate of 0.45 m/s. Integrated filling Maximum hygiene and sterile conditions need to be observed during the manufacture and bottling of liquid pharmaceutical products. Further requirements include precise dosing and maximum quality for the end-products concerned. Infusion bags are not totally dimensionally stable while they are waiting to be filled, which supposes certain extra conditions where gripping and handling technology are concerned The machine is equipped with a built-in station for the precise, automatic filling of bags. It operates to a filling accuracy of ± 0.4% for a 1,000 ml bag size. The filled infusion bags are sealed with robot precision. Another advantage, likewise offered by the KFFS, is the possibility of using different sealing systems. Marketable closure devices are in use for the tubes. Oxygen is the main factor influencing the product shelf-life. Optional for the KFFS, accurate headspace control of rest oxygen could be achieved for any given bag. A kiefel headspace analyser keeps the residual oxygen below 1%. A further key component of any quality-oriented production system for pharmaceutical products is an integrated CIP/SIP system.

<< The KFFS is equipped with a built-in station for precise filling of bags. >>

<< Kiefel’s thermo-contact welding system manufactures up to 6,000 infusion bags per hour. >>

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BLOW MOULDING

Extrusion and Injection Blow Moulding: TECHNIQUES FOR MEDICAL PLASTIC PACKAGING

hillips-Medisize has provided the following discussion of blow moulding. The company has a dedicated plant to injection blow moulding in Switzerland. A distinction is made between two kinds of blow moulding— extrusion and injection blow moulding. These techniques differ in terms of the manufacturing process, quality and design opportunities. We will look at these differences in more detail and compare the techniques. Extrusion Blow Moulding Production: When the extrusion blow moulding technique is used, as the name implies, a tubular preform is first extruded vertically downwards. The wall thickness of the end product is determined by the design of the extrusion tool or by the wall thickness of the preform and the blow-up ratio. Once the plastic has been extruded, a blow pin penetrates the preform from the top downwards. The tool—which is still open at this juncture—then closes and surrounds the preform, including the pin. Air is now forced into the preform through the pin; this inflates the preform which is pressed against the contour of the blow moulding tool and cooled. At the neck section, on the base and at the seam between the two halves of the tool, excess crushed material occurs. This excess material is generally parted when the tool is opened, but reworking is sometimes necessary. Types of plastic used: PE and PP are the most widely processed materials, but PMMA, PC and PA can also be employed. PVC use is steadily diminishing; firstly, because processing is rather complex and hydrochloric acid may be released if the technique is not correctly mastered. There is also a risk that machine parts will be attacked and undergo corrosion. Products and design: Packaging articles such as bottles, canisters or drums are the principal products. The volume ranges from 50 ml to 10,000 litres. But technical components including ventilation ducts, half-shells of suitcases, roof luggage racks and fuel tanks can also be made by extrusion blow moulding. As far as design possibilities are concerned, the advantage of extrusion blow moulding as compared to injection blow moulding resides in the possibility of achieving a large volume and the ability to shape handles or other recesses simultaneously from the same material or preform. Injection Blow Moulding Production Injection blow moulding combines the precision of injection moulding with the design possibilities of blow moulding. Injection blow moulding systems consist of an injection unit, an injection tool and a blowing tool. The preform is produced by injection moulding into the injection tool on a core. The preform is then released from the injection moulding tool and blown in the blowing tool to obtain the finished product. In the blowing mould, the preform opening—that is to say the bottle neck, for example with a thread—is already in the cooled state while the main body of the bottle remains in a warm plastic condition after which it can still be reshaped or inflated. Injection moulding of a preform gives the container produced by injection blow moulding a higher opening quality (for example for a screw cap). Significantly tighter tolerances can also be respected than when extrusion blow moulding is used. 26/ MPN /NOVEMBER-DECEMBER 2013

<< Jomar 135 blow moulding machine which is able to run 18-32 cavity tools, depending on product spec and size, in higher volumes. >> Other advantages are the assurance of uniform wall thicknesses, production free from waste, and seamless products in the neck and base areas. This enables them to resist pressure strains and endows them with high surface quality. Nowadays, a distinction is made between two main injection blow moulding techniques—the single stage and two-stage methods. In the two-stage method, the preforms are produced in advance on an ordinary injection moulding machine. The preforms are then generally sent directly to the bottling plant where they are blow-moulded on site by being inflated, and then filled directly. Lower transport costs are the main advantage of this method over the single stage technique as the preforms have a far smaller volume than the blow-moulded bottles themselves. The disadvantage resides in the high capital costs because, apart from the blow moulding machine and the blow moulding tool needed to make the bottle, a complex injection moulding tool and an injection moulding machine are also required to produce the preform. Standard preforms which are also available on the market enable capital investment costs to be reduced. But in this case the freedom to design the neck area of the bottle is greatly restricted. Because of the high capital costs, the two-stage method is viable only for very large order volumes but does bring a significantly higher potential saving through larger production quantities and shorter cycle times. When the single phase blow moulding technique, also used by Phillips-Medisize, is adopted, the entire process from injection of the preform to the inflated bottle is performed on a single machine—the injection blow moulding machine. In this way, finished products can be delivered to the customer for further direct processing.

Elasto Launches Medical TPE Compounds for Blow Moulding Applications

<< Cleanroom: The blow moulded bottles are transported from the blow moulding area directly into the cleanroom. >> << Opthalmic bottles, for example eye-droppers, made by blow moulding technology. >>

lasto, a Swedish manufacturer of TPEs, has launched medical TPE compounds for blow moulding applocations. The new TPE compounds, called Mediprene BM, have high melt strength, giving time to close the mould around the extruded parison while allowing sufficient stretchability during inflation. According to Elasto, Mediprene BM TPE compounds offer good welding in the pinchoff area of the blow mould. They can easily be coloured and give a smooth surface to the finished part. The TPE can be blow moulded into products with thin walls requiring a soft-touch feel with high levels of flexibility and durability. Mediprene BM TPE compounds can be used as an alternative to latex dipping in breathing bags. The materials are PVC and latex free, which reduces the risk of allergic reactions; Mediprene TPEs have been classified as non-sensitisers in skin sensitisation tests and representative grades have passed cytotoxicity tests according to ISO 10993-5 [Part 5: Tests for in vitro cytotoxicity] and biocompatibility tests according to USP Class VI. Mediprene TPEs are sterilisable with gamma, EtO and steam and are resistant to many fluids used in the healthcare environment. Niklas Ottosson, medical technical manager at Elasto explained, â&#x20AC;&#x153;We have a strong heritage in the medical device market and are continuously working to expand our product offering. Our goal is to engineer intelligent solutions which precisely match application requirements, but also to find solutions that meet gaps in the market. Our Mediprene BM compounds were developed in response to an increasing market interest for exploring possibilities with blow moulded medical products in TPE.â&#x20AC;? Elasto Sweden launched Mediprene TPE blow moulding compounds at the Compamed exhibition in November 2013.

<< The bottles are produced and sealed in PE-bags under cleanroom condition. >> The advantage of this technique for the customer is that he does not himself need to acquire an expensive blow moulding machine and the necessary accompanying processing know-how. Capital costs are also much lower than when the two-stage technique is used. Phillips-Medisize also welcomes the fact that this technique enables complete products with integral customer-specific design solutions to be offered to the customer, including for the pharmaceutical and medical branches where lower quantities are required than in the beverages industry. Types of plastic used: Materials like PET, PE and PP are mainly processed, but also suitable are PS, POM, PC and the COP and COC materials which are being used more and more widely in the medical and pharmaceutical industry. Products and design: Hollow moulded products in the 1.0 ml to around 2 litre capacity range are produced. The most common applications consist of bottles for liquid medicines, for example syrups, and packaging articles such as tablet boxes. The injection moulded neck area enables threads for screw caps and crimped or snap closures to be provided, while highly complex designs are also possible. NOVEMBER-DECEMBER 2013 / MPN /27

Ilustration of the Medtronic Arctic Front Advance (trademarked) Cryoballoon placed in the left superior inferior pulmonary vein. The balloon uses cryoablation, a freezing process, to destroy diseased tissue. Image courtesy of Medtronic.

FOLIO

POROUS PLASTICS

Sintered Porous Plastic: The Evolution from Industrial Applications to the Chromatrap Chip Assay Test Kit

intered porous plastics, whereby porous materials are produced by sintering together plastic particles by heat, have been used for many years for a myriad of industrial processes. These sintered materials can be made from most thermoplastic polymers, but are primarily made from polyethylene or polypropylene. They are typically produced with a pore size range from 5 to 100 micron with porosities between 35 to 50% (open volume). These products, sold under the trade name Vyon, are available in a wide variety of shapes and sizes. They can be moulded into complex three dimensional shapes, or cut from roll or flat sheet. Discs can be made with diameters as small as 2 mm or as large as 2 m. Conical hopper inserts for powder fluidisation are often fabricated with a diameter of 1 m or more. Typical industrial applications include water and air filtration, sound attenuation, fragrance emanation, vacuum table beds, powder fluidisation and battery venting. The defined pore size distribution combined with a material exhibiting excellent robustness and chemical resistance are essential properties for these applications. In more recent years these materials are being used in products and applications in the life science markets. The requirements of materials for these market sectors are usually far more stringent than that for industrial applications. They need to be free from contamination with very low levels of leachables and with full traceability. Regulatory approval is also an essential prerequisite for many of the products in these sectors. In 2007 Porvair launched its new BioVyon range of sintered porous plastic materials. These materials were specifically produced for the life science market in a new manufacturing facility that produces materials using cGMP processes. They have food contact approval and USP class VI in addition; an ISO Class 8 cleanroom (class 100,000) was commissioned for product assembly when required. Since 2007 the BioVyon range of materials has grown. It now includes composite materials where chemically and biological active components are incorporated within the sintered porous plastic material and functionalised materials where the surface of the pore structure has been directly chemically modified. Early versions of the surface modification technology have resulted in BioVyon hydrophilic and BioVyon super hydrophobic (oleophobic) and these have found major new applications in diagnostics and biochemical sample preparation. The BioVyon range of materials continues to expand and it is now being used in such applications as drug filtration and purification, catheter vents, bone cement mixing in the operating theatre and nasal spray filters. Porous plastic frits have a long history of use in sample preparation products used in analytical chemistry for drug discovery programmes and diagnostic testing. However, surface modification and composite technology has increased their application considerably.

30/ MPN /NOVEMBER-DECEMBER 2013

<< One of the most important technological improvements to BioVyon was chemical modification of the porous plastic surface. This has allowed the material to be used in test kits for disease research. >>

Oleophobic frits allow for a simpler one-pass sample preparation approach, which has been very successful. Composite frits used instead of traditionally loose packed sample preparation columns allow the analyst to use much smaller sample volumes. So less animal testing is needed, more tests can be carried out on precious human blood or urine samples, and less organic solvents are consumed during testingâ&#x20AC;&#x201D;making any test programme more environmentally friendly. An added bonus with the composite technology is that reproducibility between replicate tests has also been significantly improved. One of the most important technological improvements to BioVyon was chemical modification of the porous plastic surface. This has allowed the material to be used in test kits for disease research. The modified porous frits could then compete with the more traditional solid phases (agarose gels and magnetic beads) in immunoprecipitation (IP) assays with the added advantage that no mechanical separation is required during the loading, washing and elution steps. The most interesting of these new applications uses the modified porous frit in a spin column for a chromatin immunoprecipitation (ChIP) assay. The ChIP assay is an important tool in understanding the genetic (or epigenetic) control mechanisms in a disease pathway. The assay can be used to selectively pick out tiny chromatin (protein/DNA complexes) fragments from living or archived tissue samples to find genetic and epigenetic markers associated with disease which helps with diagnosis and in understanding the mechanisms involved in causing the disease.

â&#x20AC;&#x153;an intricate << Porex P3 Technology: irectional nid om l cel enop network of rm ifo tortuous pores which creates a un netrationâ&#x20AC;?. >> pe ial path against microb

Protein A or G are coupled to the BioVyon using chemical linkers and the material can then be used in the ChIP assay kit; its big advantages are ease of use and greater sensitivity compared with competing technologies. Greater sensitivity enables the kit to be used to detect the subtle effects of certain transcription factors on gene regulation not possible with kits using more traditional materials. In addition the rigid BioVyon solid phase lends itself to automation allowing high throughput ChIP to further speed up the understanding of disease pathways. Reliable high throughput assays carried out using 96-well microplates rather than single spin columns also opens up the use of the ChIP assay for larger scale drug screening and development programmes. The utility of BioVyon coupled to Protein A or G or other highly selective biochemical reagents such as antibodies opens up a whole range of new assay tools to help molecular biologists and clinicians understand the mechanisms underlying cancer and other common diseases and more of these assays kits are in the product development pipeline. Scientists at Porvair are very excited that these new BioVyon materials, developed in their laboratories, can now be used in a wide variety of medical and pharmaceutical applications to offer better healthcare, improve future medical knowledge and help with the diagnosis and treatment of disease.

Porex Introduces P3 Technology USA-based Porex Corporation (Porex), which describes itself as a proven market leader in porous media solutions for the healthcare markets, has introduced P3 Technology to enhance the protection of medical device and pharmaceutical packaging. Porex presented the technology on November 21, 2013, at the Compamed trade show as part of the a supplier forum held in hall 8b. Porex P3 Technology is said to have a unique combination of excellent microbial-barrier performance for superior packaging integrity and high permeability for shorter ethylene oxide sterilisation cycles. The P3 porous structure is an intricate network of open-celled omnidirectional pores, which creates a â&#x20AC;&#x153;more tortuous path to prevent the penetration of microbesâ&#x20AC;?. Porex P3 Technology can help improve the sterile integrity of medical packaging and enhance patient safety. With P3, Porex says it is setting new standards in medical device and pharmaceutical packaging. â&#x20AC;&#x153;Porex strives to create innovative solutions that solve the specific challenges of our healthcare customers,â&#x20AC;? said William Midgette, president and CEO of Porex. â&#x20AC;&#x153;Our research scientists and engineers are dedicated to delivering breakthrough innovations, such as P3 Technology, that provide next generation performance for our customersâ&#x20AC;&#x2122; products.â&#x20AC;?

BioVyonTM Technologies Sintered Porous Materials for Filtration and Separation Porvair Filtration Group manufactures and supplies a range of ultra-clean porous polyethylene and polypropylene materials for the medical, pharmaceutical and life science industries.

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NOVEMBER-DECEMBER 2013 / MPN /31

RENAL CARE

Finding the Right Material to Meet Industry and Customer Needs for the Renal Care Market by Theo Wubbels and Gopal R Saraiya

riginal equipment manufacturers work hard to develop medical devices that address specific industry and customer needs. OEMs in the renal care market face even greater challenges as performance and cost containment demands grow, along with the increasing prevalence of dialysis treatments. As the number of patients receiving dialysis grows—there are an estimated 1.7 million end-stage renal disease patients worldwide—OEMs must make informed decisions when choosing the right materials for new or redeveloped renal care devices. The demanding conditions during which renal care device housings are used require materials that are tough—meaning they must have the ability to resist cracking and breaking—that are clear, and that resist the effects of sterilisation and harsh chemicals, such as disinfectants. In addition, OEMs must consider critical market drivers of patient safety and comfort, cost containment and sustainability.

Made Strong Despite the improvement in materials used in renal care devices, OEMs still face challenges. More than 50 percent of the cracks and breaks in haemodialyser housings are related to dropping, according to a 2009 survey of the American Nephrology Nurses Association (ANNA) conducted by Eastman Chemical Company. Healthcare practitioners often tap dialyser housings to free during which renal care air bubbles, which can << The demanding conditions materials that have the uire req d expose the housing to use device housings are aking, are clear and can high-impact stresses. ability to resist cracking and bre tion and harsh chemicals. >> Cracks—and potential withstand the effects of sterilisa leaks—in renal devices can pose a huge risk to patient OEMs. The device material should not only be Alternative Materials safety and also pose economic challenges for crystal-clear from the time of development but The composition of renal care devices has healthcare facilities and device manufacturers. also after radiation sterilisation and cleaning transformed over the years. These devices The toughness of dialyser housing with harsh chemicals. Medical devices are have been made with silicon, Teflon, glass and, materials also plays an important role in sterilised prior to their use to reduce bio more recently, thermoplastics. OEMs made the protecting the delicate components in these burden to a safe level. This sterilisation must switch to thermoplastics for several reasons. devices. Fibres inside dialyser housings must minimally affect the physical and optical One was mass production and the economics remain protected if the device is dropped or properties of the devices. associated with device manufacturing. As the mishandled as well as during shipping to To combat rising hospital acquired number of patients receiving dialysis treatment dialysis treatment centres and hospitals. In infections, healthcare facilities are using grew, so did the need for more devices. OEMs addition, renal care devices are handled increasingly aggressive chemical disinfectants. wanted to keep making quality products but frequently. Some materials used for renal devices might do so more quickly and with lower production not withstand these disinfectants, causing costs—something brands could accomplish Making a Clear Choice devices to become cloudy, hazy and with thermoplastics. More than 70 percent of respondents in the susceptible to cracking. In addition, gamma and In addition, thermoplastics provided ANNA survey indicated that clarity in renal e-beam sterilisation cannot only discolour attributes needed for renal devices, including dialyser housings is important for both these devices but also make devices brittle. All toughness, clarity and resistance to radiation healthcare practitioners and patients for three of these alterations can compromise the safety sterilisation and chemicals. Today, as OEMs reasons: proper and accurate detection of air and use of these devices. develop new renal care devices with bubbles; proper and accurate detection of thermoplastic, they need to consider what clots and blood leakage from the membranes; In the Driver’s Seat material benefits will meet the technical and and peace of mind for patients, who want Beyond industry needs, many factors— manufacturing requirements of renal devices as equipment that appears new, clean and including external economic and regulatory well as the in-use demands of healthcare high-quality. factors—play into material selection for OEMs, practitioners and patients. There are other visual considerations for whether for developing new devices or changing existing ones. As medical costs rise, one driver in material selection is identifying methods of cost savings and increased efficiency. Materials that offer shorter production cycle times help save on costs, as more << Eastman Tritan copolyester offers the clarity, products can be manufactured faster, toughness and chemical and radiation sterilisation minimising energy costs. A lighter device, using resistance needed for renal care devices. >> less material, reduces the volume and therefore 32/ MPN /NOVEMBER-DECEMBER 2013

Eastman Tritan Copolyester Beginning in 2009, Eastman Tritan copolyester has been available as an alternative thermoplastic for the medical market. Since 2011, an increasing number of renal care device OEMs have been using or considering Tritan for their devices, which include haemodialysers, haemoconcentrators and haemofilter housing applications. These OEMs have found the clarity, toughness, chemical resistance and property retention after sterilisation of Tritan copolyester critical to the functionality of their devices in demanding clinic and hospital environments. Tritan, a crystal-clear material, maintains its colour, clarity and mechanical properties after gamma radiation, e-beam radiation and ethylene oxide (EtO) sterilisation. The material also maintains part integrity after exposure to lipids, sterilants and disinfectants. Renal care device housings made with Tritan are capable of protecting hollow fibre membranes. The toughness of the material offers enhanced environmental stress cracking resistance, helping reduce premature cracking and breaking. Tritan also provides a sustainable material alternative, as it is manufactured without BPA, halogens or ortho-phthalates. Due to low in-mould stresses, the costly annealing step can be reduced or eliminated when devices are made with Tritan. The higher glass transition temperature of the material, compared with heritage copolyesters, offers improved injection moulding processing of renal device housings. Looking Ahead As OEMs contemplate material options for the renal care device market, they will need to consider current industry needs as well as

Theo Wubbels

those of healthcare practitioners and patients. OEMs also will need to anticipate future needs and changes outside their control, such as regulatory measures. Tritan is one material option to consider for new and redeveloped devices. It provides an answer to current needs such as clarity, toughness, and chemical and radiation steriliation resistance. Tritan is a registered trademark of Eastman Chemical Company.

Gopal R S araiya

cost of clinical waste disposal for clinics and hospitals, and reduced shipping costs. In addition, materials that can withstand sterilisation and harsh chemicals can significantly reduce costs and wastage, as devices made with these materials do not need to be replaced as often. OEMs are more likely to rely on certain materials for device development if they know they wonâ&#x20AC;&#x2122;t become compromised after sterilisation. Another driver is patient safety and comfort. Blood clots or air bubbles that are properly and accurately detected in a renal care device improve patient safety and allow healthcare practitioners to do their jobs more efficiently and effectively. This brings peace of mind to healthcare practitioners and patients alike. Sustainability is a major driver for many medical OEMs, not only in terms of sustainable materials but also sustainable processes. Increasingly, OEMs are considering environmentally responsible materials, meaning those that do not contain bisphenol A (BPA), ortho-phthalates or halogens. In addition, some materials offer the potential for downgauging as well as reduced part weight and packaging, which may help reduce the amount of clinical waste incinerated or sent for disposal.

About the authors: Theo Wubbels is Medical Market Development Manager, EMEA, Eastman Chemical Advanced Materials BV, and Gopal R Saraiya is Global Segment Leader, Medical Devices, Eastman Chemical Company.

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IRELAND The Irish Medical Technology Manufacturing Industry:

NOTES FROM AN EXPERT SA: What makes Ireland an important country in the medtech manufacturing sector in Europe and globally? SK: As many as 17 of the top 25 medtech companies are based in Ireland, with Europe’s premier cluster of device companies based throughout the west and south west ON OCTOBER 21, 2013, THE regions. Examples of MEDICAL PLASTICS NEWS global companies with TEAM LANDED IN DUBLIN FOR substantial operations include Abbott, MED IN IRELAND, ONE OF THE Bausch + Lomb, WORLD’S MOST IMPORTANT Boston Scientific, MEDICAL DEVICE Covidien, Johnson & Johnson, Medtronic MANUFACTURING and Stryker. The GATHERINGS. FOLLOWING sector employs over SEVEN SITE VISITS, SAM ANSON 25,000 people in 250 companies and SPOKE WITH SINEAD KEOGH, generates sales in THE DIRECTOR OF THE IRISH excess of €7.9 billion MEDICAL DEVICE ASSOCIATION (US$10.7 billion) annually. (IMDA), ABOUT THE EFFECTS This continued OF THE EURO CRISIS ON IRISH investment has MEDTECH COMPANIES. stimulated the emergence of an indigenous cluster of over 100 innovation-led companies along the entire medtech value chain—from R&D intensive technologies, to proprietary products, contract design and manufacturing, packaging and sterilisation. This has positioned Ireland as a world-class centre of excellence for medical devices. SA: What are Ireland’s key strengths? SK: Ireland’s strengths are as follows. We have a plentiful pool of talent—our predominantly young workforce is capable, adaptable, mobile and committed to achievement. The median population age is 35, the lowest in the EU. We have a good track record—over 1,000 multinational companies have already chosen Ireland as their strategic European base. In terms of taxation Ireland’s corporation tax rate is 12.5%. And as far as technology is concerned, a significant level of state investment in R&D helps ensure the country stays at the forefront of innovation. Ireland leads in the skills race with a higher percentage of third level graduates [graduates of higher education institutes like universities, colleges and technical institutes] than averages in the UK, the US and the OECD. An EIU [Economist Intelligence Unit] benchmarking competitiveness report ranks Dublin as the best city in the world for human capital. Ireland’s workforce is dynamic and flexible, we can work in multi-disciplinary teams and with different cultures. Companies located in Ireland benefit from barrier-free access to over 500 million consumers in Europe, one of the largest markets in the world (approximately 23% of global GDP). English is the universal spoken language. The country is a highly developed multi-cultural community and a leading member of the Eurozone. 34/ MPN /NOVEMBER-DECEMBER 2013

SA: Tell me about some key characteristics of Ireland’s industry as well as the growth areas. SK: Three sectors are particularly prominent in Ireland— cardiovascular, orthopaedics and diagnostics. As much as 80 percent of global stent production is carried out in Ireland, with significant investment by Abbott, Boston Scientific, and Medtronic. The Galway Medical Devices Centre of Excellence (GMedTech) is actively focused on cardiovascular research in four key research topics: abdominal aortic aneurysms; cranial aneurysms; coronary artery disease and the venous system. Other areas of research include the human musculoskeletal system, dentistry, urology and reconstructive surgery. In orthopaedics, Ireland hosts manufacturing facilities by industry leaders Stryker, DePuy, Zimmer and Tornier. Ireland also boasts an incredibly strong services and contract research and manufacturing base. In fact, 50% of the companies located here are in the business to business space. Europe’s favourable regulatory environment plays a key role in attracting foreign direct investment in medtech to the country. Medical technology companies based in Ireland operate to the highest international quality standards—for example European, US and Japanese regulations. Their needs are understood by regulation agencies who work closely with them in order to achieve trouble free start-ups. In addition, certification agencies in Ireland operate in accordance with European and global standard procedures. SA: What are the main influences in medical technology? SK: Ireland is one of the most favoured European destinations for foreign direct investment and, at 12.5%, has one of the most competitive corporate tax rate in the EU. Ireland also provides a tax credit of 25% of capital and revenue spend on qualifying R&D. In the most recent Budget, the Government has committed to further enhancements to make credit ever more attractive. Compared with other geographical areas, the procedure for obtaining approval to commercialise new products is clearly defined in the EU member states. Europe has been and will very

IRELAND

<< LEFT | Med in Ireland took place at Dublin’s impressive conference centre and was attended by 340 international buyers inlcuding the world’s largest ten multinational device manufactuers. >>

<< Key to symbols. >>

<< ABOVE | Distribution of companies in Ireland which primarily design or manufacture medical technology and/or solutions (excludes distributors and consultant organisations). >>

Continued on page 36

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IRELAND Continued from page 35 likely remain an important platform for clinical development and a key source of new medical technologies. In addition, Europe is the geographical area in which medical technology companies are generally first to launch new products and procedures. As such, EU member states benefit from a comparably early and fast adoption of new technologies. SA: What challenges does Ireland face in terms of its medical device manufacturing sector? SK:. The medical technology industry globally is evolving at an incredible pace. The challenges, which range from reimbursement and regulation to supply chain and finance, are already impacting enormously on the sector here in Ireland, presenting both opportunities and challenges. Understanding global drivers and adapting business models will be key to continued success here in Ireland. SA: Tell me first about how the sector can better understand global drivers and adopt new business models. SK: It is crucial that a focus is maintained on sustaining the jobs already in existence in manufacturing. There will always be a constant churn in employment as firms re-structure globalised operations and adapt to economic circumstance. Multiple strategies exist to offset market challenges and drive growth. These are underpinned by the need to develop cost effective products, manage operating costs and product pricing to offset margin pressures and improve operational capabilities. IMDA have a very active operational excellence working group which is supporting the development of capabilities and benchmarking across the sector. Global drivers of change impact upon market growth and present opportunities for Ireland’s manufacturing firms. These drivers have been identified for the sector in the report published by IMDA and Deloitte Med Tech Ireland, Business Foresight Strategy published earlier this year. These include expanding patient base, growth in emerging markets, innovation to address unmet needs and emergence of medical apps. Growth in mergers and acquisitions and convergence of technology can also be key drivers. SA: And what about pricing and reimbursement pressures? SK: Pricing and reimbursement will continue to be a challenge as governments, private payers, patients and competitors exert pricing pressures across different product categories. Furthermore, there are reimbursement and taxation challenges elsewhere, for example the US medical device tax and more stringent EU and US product approval and safety oversight. We expect medical device manufacturers to be faced with constrained sales margins but this will affect companies all over the world. SA: And negative press? SK: The medical devices and diagnostic industry has seen a number of instances of negative publicity in recent times. European patients have benefitted from a long track record of safe and effective products, despite the recent aberration involving fraudulently altered breast implants. IMDA along with our industry colleagues in Europe have long called for a strengthening and enhancement of the regulatory environment across Europe and we welcome the majority of measures

36/ MPN /NOVEMBER-DECEMBER 2013

<< Sinead Keogh is director at the Irish Medical Device Association (IMDA) >>

outlined in the Commission’s proposals to the MDD and IVD Directives adopted by the European Parliament on October 22, 2013 (see page 8), as certain aspects of the current system need meaningful enhancement to improve safety, reflect changed expectations and technological advances. Whilst shorter term adoption of legislative proposals is desirable, it is critical that the final agreement strikes the appropriate balance between maintaining the internationally recognised strengths of the current European regulatory framework whilst addressing aspects of the current system that need enhancement. At the end of the day everyone wants the same result—safe and effective devices to treat patients and the ability to innovate to find new and better methods and devices to treat future patients. The Parliament vote now sets the scene for meaningful and productive discussions to take place between the Parliament, Commission and Council to allow Europe to stay at the forefront of medical device technology. SA: Tell me about Ireland’s relationship with the medical device industry in the USA? SK: Now, Ireland is one of the top destinations in Europe for US FDI and benefits in the form of over 115,000 jobs. The new EUUS relationship is the biggest in the world with around €2 billion of goods and services traded every day between the two. The possible implications for Ireland are fairly clear. With one of the strongest investment and trade relationships with the US, Ireland and companies in Ireland are likely to be benefit hugely from increased opportunities and ease of investment, easier regulatory recognition for pharmaceutical and medical device products and new public procurement opportunities. Ultimately, we would expect to see an increase in the volume of trade in goods and services with the EU, as well as significant convergence of a number of standards. Last year nearly half of all medtech exports from Ireland were US bound. As many as 17 of the world’s top 25 medtech companies are located in Ireland, many of which are US corporations. Continued on page 38

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IRELAND Continued from page 36 Our government agencies have also developed very strong linkages with a number of world renowned hospitals within the US including the Cleveland Clinic—a non-profit multispecialty academic medical centre—rated as one of the top four hospitals in the USA and located in Cleveland, Ohio. SA: Like most countries Ireland was a casualty of the credit crisis and required a bailout to help its economy recover. Where are things up to? SK: Ireland is recovering from a very deep downturn. The economy returned to growth in 2011 for the first time in four years. Relatively strong growth is expected over the mediumterm and the economy’s underlying strengths remain intact, with gains in competitiveness. The EU/IMF bailout programme is on track and return to markets is underway.

infrastructure, competencies and skillsets here. There is a strong future for manufacturing in Ireland, which has been recognised by our companies who have invested heavily here and by our government agencies who have identified it as a strategic area for the country. The Irish government is currently addressing cost competitiveness, but recognises that this alone will not be sufficient to ensure Ireland’s manufacturing sector remains to the forefront internationally. The Forfás Manufacturing 2020 report identifies a need for a national step change initiative, which will assist companies at the firm level, specific to its stage of development and scale to: l

SA: Sounds promising. I know it’s been a tough few years. What have been the biggest gains?

l l

SK: Ireland’s cost competitiveness has achieved some hard won gains during the crisis. The European Commission has noted that Ireland has recorded a rather steep fall in unit labour costs (ULC) and that by 2014 Irish nominal unit labour costs will have fallen by almost 13% from the 2008 peak. This is impressive compared to much smaller falls in Spain (-6.4%) and Portugal (4.1%) and rising nominal unit labour costs in Italy (10.7%) and Germany (12.7%). There has been a significant policy response, with public support. We are on track to correct the excessive deficit by 2015. There has been a determined approach to banking issues, a large improvement in competitiveness and good government employment. SA: What’s the outlook for the future? SK: The World Bank compiles an annual global ranking of the ease with which companies can do business in a country. In 2012 Ireland ranked 15th out of 185 countries and 5th in the EU. Ireland was ranked in the top ten in terms of the ease of starting a business, paying taxes, protecting investors and resolving insolvency. In comparison Germany was placed 21st while all other programme countries were place 50th or substantially above. These gains have been reflected in growing exports, particularly in high tech sectors, a growing share of world trade, and Ireland’s emergence from the bailout process later this year. SA: I’m told there have been some unexpected positive benefits? SK: From a medtech perspective, manufactures have been forced to increase comptitiveness and have stripped out inefficiencies. Many are now concentrating their resources on core technologies—a lot are now looking to outsource technologies which are peripheral—and this represents a very strong opportunity for design and contract manufacturers. These companies are becoming an increasingly important part of the value stream, heightening their importance. SA: Tell me about the steps the government has taken to help the industry. SK: The Irish government is committed to enhancing manufacturing competitiveness. It has established a cross sectorial manufacturing forum with representatives from many stakeholders to work collaboratively to develop the

38/ MPN /NOVEMBER-DECEMBER 2013

Enhance productivity and competitiveness—to embrace lean principles, sustainable (green) models and to embed ICT; Deepen engagement in innovation; To internationalise—to connect to the customer and expand into new markets; and Stimulate collaboration, peer learning and new ways of working.

The report also identifies the need to work towards promoting manufacturing as a strong career prospect and have sanctioned a number of programmes to promote the uptake of Science, Technology, Engineering and Maths (STEM) in our primary and secondary education system. A number of med tech companies are partners in the government funded Irish Centre for Manufacturing Research (ICMR), a consortium of leading Irish manufacturers collaborating to conduct embedded research and innovation. The industry-led research agenda is designed to deliver the breakthrough solutions required to maintain partners’ competitive edge. More recently, the government has also recognised manufacturing competitiveness as a key research theme under its recent Science Foundation Ireland Research Centres Call to support engineering technologies for manufacturing and pilot production. SFI Research Centres link scientists and engineers in partnerships across academia and industry to address crucial research questions, foster the development of new and existing Irish-based technology companies, attract industry that could make an important contribution to Ireland and its economy, and expand educational and career opportunities in Ireland in science and engineering. SA: Tell me about R&D. Which institutions should readers be aware of? SK: The Irish government has committed to an €8.2 billion investment in science and technology research up until 2013, funding centres of excellence like the €15 million Regenerative Medicine Institute (REMEDI), a world-class biomedical research centre focusing on gene therapy and stem cell research, and the €23 million Biomedical Diagnostics Institute (BDI), a multidisciplinary research institute focused on the development of next generation biomedical diagnostic devices. With a network of over 200 industry partners and customers worldwide, the Tyndall National Institute, a leading research centre in information and communications technology, generates around €30 million income each year. As much as 85% of this total is from competitively won contracts nationally and internationally. Tyndall is also a lead partner in European research programmes in its core areas of ICT, communications, energy, health and the environment worth €44 millionn, including €6 millionn accruing to industry in Ireland (from Framework 7).

Over the past eight years CRANN, based at Trinity College Dublin, has established a track record of research excellence in both nanoscience and materials science. This has placed Ireland on the map internationally and Ireland’s ranking of 6th and 8th in the world for nanotechnology and materials respectively are due to CRANN. Operating as an open access mode, this infrastructure provides a platform for large-scale collaborative programmes with industry. SA: A key strength of the industry on the US East Coast is a strong inteface between research institutions, manufacturers and clinicians. Is there a similar dynamic in Ireland? SK: For this sector, engagement between industry and the hospital research system is a fundamental part of the innovation process. Especially important is the role of clinicians as ‘in-market’ experts that can help to identify real world issues and opportunities, as is the involvement of patients in well managed clinical investigation. The clinical research infrastructure in Ireland has transformed over the past ten years and we have seen an increase in the number of clinical studies being carried out that required competent authority approval in Ireland. A number of key measures taken by government to drive the way towards a connected, responsive and transparent clinical research infrastructure in Ireland include: l l

The establishment of seven clinical research facilities as key loci for expertise and capacity in Irish teaching hospitals; The drive to establish clinical networks in strategic therapeutic disease areas. The networks provide a platform where relevant stakeholders can access and utilise the infrastructure, expertise and culture required to optimally support patient-focused research studies in strategic disease areas. An example includes the National Cardiovascular and Stroke Research Network (NCSRN); The establishment of the Irish Clinical Research Infrastructure Network and a dedicated Clinical Trial Liaison Officer to provide support to researchers, SMEs and multinational companies who want to engage with the clinical research community in order to conduct their clinical trial here; and The establishment of a Healthcare Innovation Hub to bring together healthcare companies, the health system and academia, in order to help such companies move faster on developing products and services. SA: Tell me more about the Healthcare Innovation Hub.

SK: The project is based on international models—such as the North Carolina Research Triangle in the USA. The idea is to help healthcare companies deliver commercial products and services more quickly by giving them access to Ireland’s health service in order to test products in a real-life environment. The project will allow the health service to become more efficient by enabling the Health Service Executive and hospitals to engage and participate with companies that are creating solutions. This is a national collaborative venture between Enterprise Ireland, IDA Ireland, Science Foundation Ireland, the HSE, Cork Institute of Technology and University College Cork. The hub is being driven by the Department of Jobs, Enterprise and Innovation and the Department of Health.

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2013 REVIEW

Medical Devices YEAR IN REVIEW 2013 By Mark Bonifacio, Bonifacio Consulting Services

here to begin? 2013 in one word—I think you’ve heard this one before—change. As with all change, there were some immediate winners and losers, while in most cases, it is too early to tell what companies and what products will be the winners in the future. I think we can look at the Patient Protection and Affordable Care Act (PPACA)—or Obamacare—as certainly the most talked about topic in 2013 that affects our medical device market. In addition to the implementation of 2.3% tax on all devices sold in the USA, we saw major issues with the launch of the online insurance portals for consumers. In focusing on some of the highs of 2013, I would be remiss if we didn’t talk about the fantastic innovation stories from 2013 that continue to push the boundaries of what we thought was even possible just five years ago. From the bionic eye and award winning technology from Second Sight, to the advancements in phase change materials that allow us to ship living organs (picture a beating heart) around the globe to waiting transplant patients. We have seen many products become smaller with the rise of more micro and nano applications as our ability to process and manufacture smaller and smaller components continues. Other procedures that normally required major incisions and patient trauma along with extended hospital stays are steadily being replaced by MIS (minimally invasive surgical) operations. Neurological science is finding more and more connections in our brain that affect other health conditions with the revolution of innovation in this area in its infancy. Using the latest MIS catheter technology surgeons can now replace a failing a heart valve with only a small incision while using the femoral artery to deliver the valve to the heart. This procedure—which was at one time a chest splitting, open heart surgery that caused major trauma and blood loss along with extended hospital stays and recovery times—is now being replaced by this MIS procedure requiring only a two- or threeday hospital stay. Indeed, it is slowly becoming a “routine” procedure in some cardiac centres. There is not one medical device market, from ophthalmology to orthopaedics and from IVD to cardiology and neurology, that has not seen some level of advancements. Progress continued in bioabsorbables and implantable materials, as more new products came to market in 2013. Talking about 2013 would also not be complete if we did not mention the advancements in tele-health, tele-medicine, mobile health and consumer health. The convergence of the software / app world with the medical device community is blurring the lines of what even constitutes a medical device these days. The iPhone and other smartphones can perform diagnostics

40/ MPN /NOVEMBER-DECEMBER 2013

procedures (such as sleep studies, skin or melanoma diagnostics and blood pressure monitoring to name just a few) while also tracking physical activity and caloric intake along with other vital signs. Healthcare reform in whatever from it eventually takes in the USA and globally will certainly involve consumers being more involved in the spending of their healthcare dollars. At 18% of GDP in the USA, the current rise of healthcare has no choice but to slow down. The USA is currently spending at almost twice (% GDP) than any other nation. Medical device manufacturing and contract manufacturing saw glimpses of “re-shoring’ or “near-shoring” of production back to the USA or Mexico (or other North America locations). The output of the outsourcing and contract manufacturing sectors saw robust growth with no immediate signs of slowing down as OEMs looked to leverage their internal resources and partner with outsource providers where it made logistical and economic sense. One additional strategy continuing to emerge in 2013 was device OEMs building or acquiring design and manufacturing centres in or very near to the emerging and new markets they want to serve. Progressive and forward thinking OEMs realise that a new breed of products or completely different products, therapies and cost structures will drive growth in emerging and faster growth markets. While some recent estimates have revised downward some projections, all estimates point to the BRIC nations as the fastest growth sectors over the next decade and beyond. In closing and looking back, while 2013 was filled with some uncertainty and headwinds in our industry I believe there remains a robust pipeline of innovation that will shape our industry in 2014 and beyond. Technology and the convergence of technology with devices, along with therapies and novel / innovative models of delivering healthcare will be the new normal as cost control is no longer an option but a must. Incremental improvements in products will continue to be replaced with disruptive and novel approaches that increase efficacy of outcomes while reducing costs. With that said, I will leave you with this statistic. In 2012, medical devices in the USA made up roughly 4% of our entire US$2.6 trillion dollar total healthcare spend. I think it should be clear to everyone that the value our society receives from medical devices is undisputable. Let’s get ready for 2014, I believe it’s an exciting time for practioners, patients and all of us involved in any facet of the healthcare puzzle to be a part of such a vibrant and rapidly changing medical device industry and healthcare community that is making a positive impact in the quality of people’s lives around the globe.

About the author: Mark has over 20 years of senior level experience in leading and assisting organisations in the manufacturing of medical devices and the medical plastics and injection moulding industry. As President of Bonifacio Consulting Services, Mark brings thorough technical knowledge and business leadership experience in global medical device manufacturing, engineering, operational, and financial strategies to early stage, middle market, and Fortune 500 firms. Mark has worked extensively with medical device firms in the USA, Mexico and China. Prior to starting his consulting firm, Mr Bonifacio was co-founder of medical contract manufacturer, APEC (1997) in Baldwin Park, CA (now Helix Medical) and has held various operational, engineering, and business development roles during his career. Mark holds a BS in Plastics Engineering from University of Lowell (now UMASS Lowell), sits on various advisory boards, and remains active with the UMass M2D2 programme and many other local medical device networking, non-profit and professional organisations. Mr Bonifacio also serves as Chair of the Medical Plastics Board of Directors with the (SPE), Society of Plastics Engineers. Mr Bonifacio has direct working experience in North America, Mexico, China, and Europe. Working on various acquisitions, startups, and outsourcing initiatives. Mr Bonifacio is an active public speaker and has published many papers on innovative device manufacturing and outsourcing. Mark currently resides in Natick, MA, USA, with his wife Patricia and three boys. NOVEMBER-DECEMBER 2013 / MPN /41

REGULATION REVIEW

Navigating Risk in Medical Materials Supply By Alexander Silvestre, Global Director of Healthcare & Diagnostics, Styrolution

ntroducing new medical devices in today’s shifting regulatory environment is a long and expensive undertaking. On average, the international approval process can take anywhere from one to ten years, requiring comprehensive applications with up to ten different approval agencies and amassing costs between $100,000 and $250,000 per approval.

Challenges and Costs of International Approvals

Though the Asia Pacific region is not as regulated as the US and EU, it is slowly following suit. Countries like India are just beginning their regulatory programmes.

HD D HD Demand emand by by Region Region - 2012, iinn % of Weight Weeight

Average cost per approval: $100,000 - $250,000 Typical Approval Time: 1-10 years Number of Approval Agencies: 5-10+ If that weren’t enough cost, companies face the loss of hundreds of thousands of dollars in resources if the wrong material is selected or if final market approval is not secured. Suppliers and manufacturers that proactively manage risk throughout the product life cycle can significantly reduce their time and costs spent on compliance. By tackling compliance early and strategically—and not as a final stage of paper pushing and hoop jumping right before launch—manufacturers can better mitigate risk and derive real business advantages as a result. Advantages include improved time to market and the reallocation of resources for innovation and growth. Healthcare and diagnostic (HD) material suppliers like Styrolution, a global leader in styrenics, are doing just this by designing full-service product packages with fixed formulations, product co-development and assistance with international compliance. Their experienced and dedicated medical team is there to help customers navigate the current regulatory environment. The Current Regulatory Environment for HD Material Supply While general requirements for raw material producers have not changed dramatically in recent years, there is a clear trend towards the acceptance of a global system. Where USP Class VI, the US norm, was once acceptable, today’s requirements must adhere to international norms, or ISO10993. Even as regulators move toward international requirements, the absence of a single global system means separate submissions must be made to individual governing bodies and countries. To be competitive and successful in the global medical market, each new medical material must fulfil USP requirements (for example, meet monograph specifications or USP Class VI requirements), ISO10993 biocompatibility testing, and establish compliance with US FDA and EU food contact regulations and European and Japanese Pharmacopeia requirements. Suppliers must also demonstrate a fundamental knowledge of the risk classes for medical applications as well as good manufacturing practice to ensure that product is manufactured in a manner suitable and appropriate for its intended use. The application process, which must be managed and owned by the final product manufacturer, does vary from region to region. Key markets like the US and the EU are highly regulated to protect patients and have similar submissions processes.

EEurope urope R. R.O. O.W.

North North America America A Asia sia

<< Steady demand for medical devices is expected to continue in the US and the major Asian and European markets. For 2013 and 2014, the industry projects doubledigit growth of 10-11% in the Americas, followed by 15% for Asia, and a strong 6-8% market expansion in Europe. >> Source: Styrolution, ESPICOM 2011, Clearwater corp, USA Medical Device Report & GBI Research. In spite of regional differences, manufacturers can expect comprehensive applications that require the following for all regions: l Disclosure of components used in the healthcare device itself as well as the packaging and delivery systems for the product; l Reports on testing of the final device; l Full information on the intended uses and extent of contact with the human body; and l Information pertaining to the specific application. How Styrolution Minimises Risk for Healthcare Manufacturers An innovative partner with more than 15 years of medical industry expertise, Styrolution offers a broad range of compliant products and services that help customers proactively address regulatory change and long lead times. Its full-service product package delivers an unparalleled combination of product codevelopment and comprehensive regulatory assistance combined with fixed formulations for up to three years. Additional cross-functional team support and on-trend industry solutions mean manufacturers receive a level of service that goes well beyond industry benchmarks.

Continued on page 43 42/ MPN /NOVEMBER-DECEMBER 2013

BIOCOMPATIBLE POLYMER SURVEY The MPN Biocompatible Polymer Survey is the most advanced independent market research initiative the medical plastics industry has seen. It is a comprehensive assessment of opinions about polymer materials from the medical polymer processing communities in Europe and North America. Processors have scored various brands of biocompatible polymers in terms of how aware they are of the brand and how much they like it. The survey is a critical piece of research and a must-see for any marketing and corporate communications manager. It will help you understand what the market is saying about your brands, and most importantly, where your brand sits amongst its competitors. Example: Engineering polymer brand recognition Q7: Look at the following list of engineering polymer brands and tick all the brands that you recognise. By recognise, we mean you have heard the name or seen the logo before.

Brand A Brand B Brand C Brand D Brand E Brand F Brand G

Methodology and scope The survey is representative of the US and European medical polymer processing community. Brands have been included if they have been tested to at least one part of ISO10993 or USP Class VI. To ensure the results are meaningful, we collected details of all brands and separated them into the categories below. This ensures brands are comparable with each other. For example, PEEK needed to be separated from LDPE as they serve very different applications at different price points.

The categories are:

Brand H 0

% of respondents

The results will tell you: • • • •

Manufacturers rated in the survey

How well the market knows your brands How well liked those brands are by buyers How your brands compare against competitors What decision makers are saying about you

About DJS Research The survey was carried out by independent company DJS Research. DJS complies with the UK's Data Protection Act and its adherence is registered with the Information Commissioner (Z1091106). DJS is part of the Market Research Society. All projects use the strict privacy and data protection guidelines laid down by that body. Its internal procedures are ISO9001:2008 accredited. The most recent audit was in January 2013.

• • • • • • • •

Polyolefins Engineering polymers Polyketones High performance polymers Resorbable polymers TPEs Silicone rubbers PVC compounds

The full report includes: • Familiarity versus favourability charts and brand rankings for all polymer categories • Strongest overall brand by region • Industry outlook by medical polymer processors • Strongest brand by polymer category selected • All supporting data

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The following biocompatible polymer manufacturers have been scored and rated: • Advansource • Altuglas • Arkema • Azoty • BASF • Bayer MaterialScience • Bluestar • Borealis • Braskem • ChevronPhillips • ChiMei • CP Chem • Dow • DSM • DuPont • Durect • Eastman • Elasto • EMS Grivory • Evonik • ExxonMobil • Ineos • Invibio • Kraiburg • Lubrizol • LyondellBasell • Mitsubishi Chemicals • Momentive • Poly-Med Inc • PolyOne • Purac • Sabic • Sabic IP • Solvay Specialty Polymers • Styrolution • Styron • Teknor Apex • Ticona (now Celanese) • Topas • Trelleborg • Unigel Plasticos • Versalis • Wacker

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REGULATION REVIEW Continued from page 42 Full-Service Product Package The Full-Service HD package offers high-quality styrenic products and is designed to save customers time and money, so they can focus their energies on product vision and design. The package includes three key components: Fixed resin formulations and long-term global availability as defined in the Drug Master File (DMF): Styrolution is committed to the medical industry and guarantees 36 months of NoC (notification of change) for its full-service HD products, including a back-up production plant filed in the DMF (Drug Master File). Styrolution also secures long-term, global availability of materials and requires its raw materials suppliers to guarantee the purity and compliance of their ingredients. Comprehensive regulatory support Styrolution helps to support customer’s worldwide approvals for pharmaceutical and medical applications by providing regulatory determinations on its own products such as USP Class VI, ISO 10993 and FDA, maintaining Drug Master Files (DMFs) and providing DMF letters of authorisation on its products. Product co-development Thanks to its processing expertise and broad experience, Styrolution is an attractive partner for co-developing new devices, technologies and solutions for healthcare and diagnostics customers. A look at the step-by-step process reveals how collaborating with Styrolution is different: 1. Medical customer communicates their needs to Styrolution. 2. Styrolution listens, reflects, and asks for specific application, regulatory requirements and risk classification to further clarify the requirements. 3. Styrolution draws on its wide expertise to present the customer with the optimal mix of service packages, products and colour customisation at its Color Competency Centre in Cologne, Germany. 4. Customer and Styrolution finalise plans to co-create a new application or customer selects a service package of an already existing product. 5. Customer starts clinical trials and Styrolution supports with sample requirements. 6. Commercial production begins. Cross-functional team support Customers have the support of a dedicated global HD team with long-term experience and in-depth knowledge of the medical industry. They are also supported by research, marketing, sales, regulatory, legal and any other department that may become important in order to support a customer’s requirements. And Styrolution’s global regulatory team takes advantage of seminars, online activities, and discussion with third-party experts and consultants to stay informed of developments in the healthcare field. On-Trend Solutions Styrolution follows market trends like plasticiser free developments for flexible medical applications and has defined eight sub-segment categories to respond to customer, patient and market needs for the development of medical devices. Each segment has a segment champion that possesses in-depth knowledge of the market segment, key requirements and trends. The benefits of proactively managing risk—and choosing the right material supplier—are clear. In addition to cost savings and resources that can be focused on innovation and growth, manufacturers can improve execution against programme expectations and get their devices to the market faster. Ultimately helping the patients that need them. 44/ MPN /NOVEMBER-DECEMBER 2013

SPI Advocacy Addresses Critical Issues for US Plastics Industry By Bill Carteaux, President and CEO, SPI: The Plastics Industry Trade Association

epresenting every link in the US plastics industry supply chain, including brand-owners of plastics-intensive products, SPI: The Plastics Industry Trade Association carries out a broad variety of functions on behalf of its member companies. These include trade shows, conferences, educational activities, communications programmes, statistical reports and much more. SPI’s ongoing legislative and regulatory advocacy on behalf of the plastics industry at all levels of government is at the heart of what the association stands for. A strong and united industry approach to legislation and regulation is increasingly critical to the success of the industry and its component businesses because government agencies are increasing in size and extending their reach. The number of regulations affecting American manufacturing, including the plastics sector, has increased steadily in the last few decades. The food, medical, pharmaceutical and cosmetics sectors draw a significant share of the regulatory and legislative attention, much of it focused on product contact materials. Plastics increasingly are the material of choice for packaging in those sectors, thus it is essential that SPI advocates for fair, sciencebased treatment of our industry. The focus on these sectors is not a new phenomenon. The SPI Food, Drug & Cosmetic Packaging Materials Committee (FDCPMC) was created in 1957 and brings together industry leaders from the entire plastics supply chain. FDCPMC specialises in monitoring plastics regulatory issues and supporting the US Food & Drug Administration (FDA) and counterpart global agencies in the development of fair and effective rules. FDCPMC works directly with FDA regulators and the agency counterparts to promote policies that strengthen the plastics packaging sector. FDA representatives are frequent presenters at well-attended FDCPMC meetings and conferences. This gives individual SPI member companies and the entire plastics industry numerous opportunities to help develop industry guidelines and standards that consider their interests. FDCPMC events include the Biennial International Symposium that brings together experts in diverse disciplines from around the world to confer with SPI members. Its SemiAnnual Technical Conference brings together professionals from the entire supply chain for focused updates on issues, policies and regulations that impact the industry. Another SPI organisation, EHS+, centres on environmental, worker health and safety and product regulatory issues for all segments of the plastics industry. EHS+ monitors activity, keeps SPI members informed, and engages on key regulatory matters across state, federal and international levels, with a focus on the US Environmental Protection Agency (EPA) and the US Occupational Safety and Health Administration (OSHA). EHS+ provides industry professionals with a forum for the exchange of information and best practices, as well as opportunities to interact with representatives of government agencies and other invited meeting guests. Currently, EHS+ topics and areas of engagement include: combustible dust, crystalline silica, hazard communication, machine safety, recordkeeping, voluntary and enforcement programmes, leading indicators of environmental and safety performance, air and water quality standards, chemical risk assessments and regulations, global chemicals management and product stewardship initiatives.

Based in Washington, DC, SPI’s staff includes specialists with broad experience in legislative advocacy. They meet frequently with senators, representatives and their staffs to discuss key issues, supply information and present the plastics industry’s positions. They also help member companies arrange meetings and plant tours with specific legislators when needed. SPI’s Advocacy Group organises a “fly-in” once a year that brings plastics industry leaders to Washington for pre-arranged meetings with their senators, representatives and members of their staffs. In July 2013 over 90 meetings were completed in one day, and this year seven other associations participated in the event. The plastics industry professionals who attended reported that their issues were heard and discussed. Besides bringing plastics professionals to Washington, the advocacy team arranges for federal and state legislators to visit the factories of plastics companies. This enables the legislator to see how plastics manufacturing operations are conducted, whether it is moulding, mould making, extrusion, blow moulding or making the production machinery and auxiliaries used in converting plastic materials into finished products. The economic, trade, tax, regulatory and other issues that SPI’s advocacy team has been working on recently are numerous and varied.

<< Bill Carteaux is President and CEO of SPI: The Plastics Industry Trade Association based in Washington, DC. >> For example, virtually everyone agreed that the “Toxic Substances Control Act” passed in 1976, and not much changed since then, needed major reform decades ago. SPI has long advocated for reform that would allow modern scientific and technical knowledge to be included in such regulation. In May 2013 a bipartisan group of US Senators—a rarity in Washington these days— introduced the “Chemical Safety Improvement Act of 2013,” which is based on the inputs and interests of a broad spectrum of stakeholder

viewpoints, including those of SPI on behalf of the plastics industry. It is currently proceeding through the lawmaking process. Another successful example of SPI advocacy is the recent recommendation by the US General Services Administration (GSA) to the US Department of Energy (DOE) that both the Green Building Initiative’s Green Globes 2010 and the US Green Building Council’s (a private organisation) Leadership in Energy and Environmental Design (LEED) 2009 systems allow GSA to measure how federal buildings can best save energy, improve overall building performance and reduce utility costs. Not included in GSA’s final recommendation to DOE was the as-yet unreleased LEEDv4 system. SPI, the American Chemistry Council, the Vinyl Institute, and a number of other groups previously formed the American High-Performance Buildings Coalition to, among other things, encourage GSA to avoid LEEDv4 because it awarded points for excluding specific materials already proven to improve a building’s energy efficiency. SPI’s advocacy is also aimed at issues that, while less visible, are still important to plastics companies. For example, SPI worked with the states of Florida and California regarding the tax treatment of new equipment purchases, and both states have granted significant tax abatements.

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DESIGN 4 LIFE

Case Study: Hochschule Coburg’s 3D Printed Knee Protector for Mountain Bikers Provides Superior Safety

ne of Germany’s leading academic research institutions, Hochschule (HS) Coburg University of Applied Sciences, is using 3D printing for faster and more accurate product design projects. A GERMAN GRADUATE Based in Bavaria, Germany, the OF PRODUCT DESIGN university works in close FROM HOCHSCHULE cooperation with around 75 (HS) COBURG international partners and has close UNIVERSITY OF links with business and industry. Tobias Lehne, who intitiated the APPLIED SCIENCES HAS HS Coburg Knee Protector Project, MOVED FROM HAND- followed his passion for mountain MADE PROTOTYPES TO biking while completing his 3D PRINTING WITH THE Bachelor of Arts degree in STRATASYS OBJET Integrated Product Design. For his EDEN500V AND THE final year project, Lehne developed STRATASYS MULTI- a prototype for a more advanced MATERIAL OBJET500 knee protector that is not only a CONNEX 3D PRINTERS. shock absorber but also offers protection against almost any fall or accident.

<< Knee protector for mountain bikers produced on an Objet500 Connex3D Printer. >>

“I’ve always been interested in mountain biking but discovered a crucial gap in the market for a knee protector that interacts and shields the soft structure of the knee joint, rather than current options that merely protect against scratching,” says Lehne. Successful collaboration University projects, by their very nature, encourage experimentation with different technologies. The initial stage of Lehne’s project saw him produce samples using a variety of foams and straps to test the structure of the knee protector. “Use of foam was a cost-effective option and a good starting point, however I found this material not to be of a professional standard for my final presentation.”

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Lehne explained his vision to Professor Peter Raab, Basic Principles of Design and Design Theory Professor at HS Coburg. Professor Raab had had prior experience with Stratasys following the university’s collaboration with the company on a 3D printing project at the Euromold tradeshow in 2011. “It was clear Professor Raab knew the ideal solution to my prototyping needs,” explains Lehne. “He introduced me to Stratasys 3D printing solutions as he knew what the technology could offer for my project’s quality and functional requirements.” Precise quality achieved more quickly The university subsequently worked in collaboration with Stratasys to 3D print knee protector prototypes, and in doing so, has been able to produce examples to exact specifications, superior in quality to those produced manually, and in a much shorter time frame. “The advanced capabilities of Stratasys’ PolyJet 3D printing technology were key to bringing this project to life,” says Lehne. “The first time I saw what it could produce it surpassed all my expectations. The knee protectors not only boast a professional high quality appearance, but most importantly, they are useable prototypes,” he adds.

<< Flexible span tapes produced on an Objet500 Connex multi-material 3D printer using black rubber-like (TangoBlack) material. >>

Functional materials The main body of Lehne’s knee protector prototype was 3D printed on the Stratasys Objet Eden500V using rigid white opaque material (VeroWhitePlus). This durable photopolymer prints accurate, realistic models that test fit, form and function, even for moving parts. Flexible span tapes were produced to allow users to comfortably adjust the knee protector to their needs. These were printed on the Objet Connex multi-material 3D printer using rubber-like material (TangoBlack), offering tear resistance and tensile strength. Lehne concludes, “The Stratasys 3D printing technology has played a primary role in the quality of my project. I’m still amazed how fast and versatile it is. I think that it will completely replace hand-built models and will be more widely used in regular production lines.” For more information please contact Tobias Lehne (kontakt@tobiaslehne.de) or Professor Peter Raab (raab@hscoburg.de).

A Quick Guide to Stratasys Design 3D Printers Manufacturing by its very nature, demands a quick-turn around of high-quality prototypes for functional testing, causing more and more engineers to move from traditional, timely methods to alternative approaches. This has seen a growth of manufacturers turning to 3D printing in a bid to reduce their turnaround time and produce high-quality, functional prototypes. USA-headquartered Stratasys offers three series of 3D printers—the Idea, the Design and the Production series. Stratasys says that the medical field can benefit most from the Design series, by “meeting every prototyping requirement, whether it is precision or performance, while reducing costly mistakes and improving patient care”. Hospitals and dental practices using Stratasys 3D printing technology have reportedly seen a dramatic reduction in cost and time. Benefiting from a quicker and more accessible approach to edit and produce the models, these practices have moved from traditional methods, where if there was a mistake, the model would need to be redone from scratch. The Objet30 is the “ideal” solution for the medical field, offering models with high detail,

accuracy and a smooth surface finish. Using Stratasys’s PolyJet technology, users can produce realistic models in-house, quickly and easily.

labs worldwide for a wide range of applications, from stone models and orthodontic appliances, right through to models for clear aligners, retainers and surgical guides. The Objet Eden260V, which prints at 16-micron layers, is designed to deliver professional-grade models with exceptional details and accuracy.

<< The Objet30 is said to be the ideal solution for the medical field. >> The Objet Eden260V 3D Printer, with the special VeroDent material, is the rapid prototyping solution of choice for many dental

<< The Objet Eden260V 3D Printer is used by many dental labs worldwide. >>

NOVEMBER-DECEMBER 2013 / MPN /47

DESIGN 4 LIFE

Styrenics Set to Play “Major Role”

IN 3D PRINTING

tyrenics are set to play a pivotal role in one of the hottest trends in decades—3D printing—according to German manufacturer of styrene polymers Styrolution. The announcement has been made following news that the company has partnered with Neue Materialien Bayreuth (NMB) and the University of Bayreuth. Together the partners will develop materials for 3D printing as a strategic project. IT analyst firm Gartner predicts that “worldwide shipments of 3D printers are expected to grow 75 percent in 2014 followed by a near doubling of unit shipments in 2015. The consumer market hype has made organisations aware of the fact that 3D printing is a real, viable and cost-effective means to reduce costs through improved designs, streamlined prototyping and shortrun manufacturing.” Styrolution is already a key material supplier for a portion of the market’s plastic ink used in 3D printing. Styrolution recently hosted a panel discussion about the future of plastics and the role of styrenics. Lightweight materials and 3D printing were key trends that panelists addressed in the discussion. A video summary is available on request from the editor. The partnership with NMB and the University of Bayreuth will enable Styrolution to complement its existing R&D efforts by tapping into the broad intellectual and infrastructural polymer research resources of its new partners. This goes beyond traditional models of corporate cooperation with academia in that NMB and the university are making their infrastructure easily accessible to Styrolution. The partnership enables the company to focus its R&D activities on downstream customer innovations across five core industries: automotive, electrical and electronics, household appliances, building and construction, and healthcare and diagnostics. The initial projects will focus on the fields of lightweight structures and 3D printing. The key points of the partnership are as follows. A unique R&D model for the plastics industry: Going well beyond sponsoring a graduate-level research project, the partnership offers Styrolution a dedicated research team, including a managing scientist and access to other highly qualified research personnel through NMB. The managing scientist’s role will be to constantly evaluate new technologies for use in the field of styrenics. Styrolution expects this permanent seed creation process to steadily grow the innovation pipeline in both size and value. Through its close cooperation with the Department of Macromolecular Chemistry at the University of Bayreuth, Styrolution will also profit from the expertise of world-renowned experts like Professor Hans-Werner Schmidt (pictured left, standing), who has profound expertise across many areas of basic and applied polymer science. In addition, the company will enjoy direct access to both NMB’s and the university’s laboratory facilities and technical infrastructure, where Styrolution can conduct material and processing analyses as it further develops

<< Representatives celebrate the partnership—Volker Altstaedt, CEO Neue Materialien Bayreuth (left, sitting); Professor Hans-Werner Schmidt, head of the department for Macromolecular Chemistry, University of Bayreuth (left, standing); Professor Stefan Leible, President of University of Bayreuth (right, standing); and Dr Norbert Niessner, Director global R&D, Styrolution (right, sitting). >> 48/ MPN /NOVEMBER-DECEMBER 2013

new styrenic products for customer applications. The location will also play a key role since the Upper Franconia region in Germany is known throughout Europe as a hotbed for polymer innovation and is home to a host of companies specialising in polymer production and compounding. Customer-centric innovation is at the centre of Styrolution’s market approach: True to its claim—Driving Success, Together—Styrolution takes pride in working shoulder-toshoulder with customers to help them achieve their business objectives. This also applies to the field of innovation, where Styrolution offers services ranging from development support all the way up to co-creation projects to solve polymer challenges for specific customer applications. Styrolution will also leverage the partnership to pursue frontline development projects that will expand the scope of Styrolution’s technologies. Addressing the latest trends in material innovation: Styrolution will focus its R&D resources in Bayreuth on the next generation of material development to ensure it continues to remain at the forefront of innovation. Lightweight structures: Manufacturers from industries ranging from automotive to building and construction turn increasingly to styrenics for lightweight alternatives to other materials, such as metal or heavier plastics. Through the partnership, Styrolution will put greater emphasis on optimising and developing new styrenics-based lightweight structures that will promote further carbon footprint reduction and fulfill the sustainability requirements of its customers. Styrolution will benefit from expertise in polymer foams, polymer composites and sandwich materials held by the polymer division at NMB and the university’s Department of Polymer Engineering, both of which are headed by a world-renowned scientist in the field of applied polymer science, Professor Volker Altstädt (pictured left, sitting).

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Beyond Compliance

egulatory approvals for medical devices are governed by EU and UK law (Medical Devices Regulations 2002 (as amended) issued under the Consumer Protection Act 1987). EU regulations apply directly to the UK and do not need to be transposed. The AS EUROPEAN PARLIAMENT obligations on manufacturers to ensure their devices DEBATES THE FUTURE are are safe and fit for their REGULATION OF THE intended purpose before MEDICAL DEVICE MARKET, they are CE marked and TWO LEADING placed on the market in any ORTHOPAEDIC SURGEONS EU member state. To obtain a CE mark the manufacturer EXPLAIN THE THINKING submits a dossier to the BEHIND A VOLUNTARY UK relevant Notified Body that INITIATIVE WHICH GOES describes the device and its BEYOND NORMAL intended use and defines variants. If the device is REGULATORY APPROVALS any part of a “family” (typical for FOR MONITORING HIP AND knee replacements) the KNEE REPLACEMENTS. rationale for this has to be outlined from the point-ofview of design, technology, and functionality. The product or family conforms by verifying the conclusions of the risk analysis, all applicable essential requirements have been addressed, relevant applied, and the conclusions of the clinical data. To introduce a new joint replacement in the UK involves a pathway of regulatory approvals through the National Joint Registry (NJR), the Orthopaedic Data Evaluation Panel (ODEP) and the Medicine and Healthcare Products Regulatory Agency (MHRA). The company registers the device, submits the supporting data and moves towards the 10-A benchmark through pre-entry, 3-, 7-, and 10-year benchmarking by ODEP. Beyond Compliance is an initiative that is voluntary and goes beyond the normal regulatory approvals. It has to be voluntary to avoid problems with the competition laws of the EU. It aims to provide the manufacturer with post-marketing surveillance and help with iterative designs, as well as novel devices. This is supported by the UK government through its aim to increase manufacturing to boost the economy. In 2011 £5 billion was generated through the manufacture of single-use devices, wound management devices, orthopaedics implants and professional services. Beyond Compliance is about accelerating gaining regulatory approvals for innovative products to obtain better patient care and quality-of-life, and decreasing costs to the NHS (the National Health Service—the state-financed healthcare provider in England and Wales). It should also halt failing products earlier to the benefit of all. Beyond Compliance will help manufacturers by giving advice on setting up post-marketing surveillance, commenting on proposed post-market clinical follow-up studies as part of postmarket surveillance, and offering advice on the clinical outcomes to be met (such as duration of follow-up, additional tests, and timelines). Ideally, entry of the device should start before CE marking to help with submission of data to the Notified Bodies and provide an independent data monitoring service. It will provide post-marketing clinical follow-up data on new products (collected via the National Joint Registery), analysis and assessment of individual adverse events, scan for early signals of possible problems and advising on consequent actions, and

50/ MPN /NOVEMBER-DECEMBER 2013

provide regular feedback to both manufacturers and participating clinicians about how the device is handling across the whole patient cohort. Advice to industry and/or the Notified Bodies will include aspects of clinical investigations on new and innovative products, the methodologies for a clinical investigation plan including numbers, aims and objectives, end points, and the centres (and clinicians) which might carry out clinical investigations. The inclusion criteria are: l first time use in the UK; l production of implant new to manufacturer; l alteration in fixation, working or bearing surfaces; l change to the materials used; l and any major design change. Beyond Compliance has a steering committee that is composed of a chairman and vice-chairman, with representatives from the British Orthopaedic Association (BOA), British Hip Society (BHS), British Association for Surgery of the Knee (BASK), Association of British Healthcare Industries (ABHI), MHRA, Department of Health, Notified Bodies, NHS Supply Chain, and the National Joint Registry. Currently it is in a pilot phase. The legal basis is currently being worked through. Representatives of the ABHI are concerned because the initiative is resourced by NHS Supply Chain. They see a conflict of interest since NHS Supply Chain is involved in implant purchasing. Structures are easy to put in place to exclude NHS Supply Chain seeing any confidential information. Since the initiative is aimed at improving the patient’s lot and protecting them from harm, the onus is on all parties to resolve this. Currently the regulatory approvals to get a new medical device on to the market are complex, resource intensive and time-consuming. However innovation is good for patients and the economy. Beyond Compliance is an initiative aimed at helping both patients and industry. It is a win-win for all parties. Authors: Professor Simon Donell BSc FRCS(Orth) MD Consultant Orthopaedic Surgeon Norfolk & Norwich University Hospital Honorary Professor University of East Anglia President British Association for Surgery of the Knee (BASK) Professor Peter Kay M.B. Ch,B. BA. FRCS(G), FRCS(Eng). Consultant Hip and Knee Surgeon Wrightington Hospital, UK. Clinical Professor of Orthopaedic Surgery Manchester University. National Clinical Director Musculoskeletal Services (NHS England)

Medical Plastics News would like to credit the UK’s Healthcare and Medicines Knowledge Transfer Network (KTN) for the professional introduction to Simon Donell. Confirmed exhibitors as of July 23, 2013. For the latest list visit www.mediplasuk.com/sessions.html.

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ANTI-THROMBOTIC ADDITIVES << Alexandra Piotrowicz, senior engineer at Canada-based Interface Biologics Inc, focused on the development of anti-thrombotic and antimicrobial technologies for bloodcontacting medical devices.>>

The Story of Endexo Anti-Thrombotic Polymer Additives from Interface Biologics

ne of the greatest challenges for implanted medical devices is to overcome the body’s own defence systems. Unfortunately, the immune system treats all foreign materials as threats, including medical implants whose purpose is to restore health or prolong life. Interface Biologics Inc (IBI) is a Canada-based company that develops transformative biomedical polymer technology with the purpose of improving the safety and effectiveness of medical devices, addressing the body’s own defence system. It all started back in December 2001 at the University of Toronto in Dr Paul Santerre’s lab, with his groundbreaking work on materials for improving the biocompatibility of medical implants. Seed financing was raised from venture capital funds to demonstrate proof-of-concept of the now trademarked Endexo technology for providing anti-thrombotic character in a variety of polyurethane chemistry applications such as catheters, blood bags, stent grafts and other blood contacting devices. The Endexo technology encompasses a range of low molecular weight additives for reduced thrombus formation on devices without the use of heparin. It was expanded to a widerange of polymers including many medical grade plastics with different hardnesses, processing temperatures and processing means (for example, injection moulding, solution spinning or extrusion). In 2005, post Series A financing, Interface Biologics moved into Toronto’s acclaimed MaRS Innovation Centre, a collaborative facility dedicated to accelerating emerging technologies. This is

<< The Endexo technology provides a passive surface that reduces adhesion and activation of blood proteins and components, thereby reducing thrombus formation. This feature is useful in vascular access catheters where thrombus formation can lead to deep vein thrombosis (DVT) and subsequent downstream emboli, resulting in high morbidity and mortality. >>

52/ MPN /NOVEMBER-DECEMBER 2013

located near the University of Toronto campus and is close to seven specialty hospitals. Within their newly built state-of-the-art lab facilities, IBI began working with a wide variety of catheter manufacturers to better understand the implementation of the Endexo technology in a specific application. Endexo is a low molecular weight polymer with a range of chemistries. IBI has numerous different formulations depending on the application and base polymer requirements. The chemistry make-up allows the molecules to migrate to the top nanometers of material interface, such that it is present on all surfaces. The additive is typically added at 1-5 weight percent and provides significant surface modification. The Endexo technology provides a passive surface that reduces adhesion and activation of blood proteins and components, thereby reducing thrombus formation. This feature is useful in vascular access catheters where thrombus formation can lead to deep vein thrombosis and subsequent downstream emboli, resulting in high morbidity and mortality. Endexo technology is currently licensed to AngioDynamics for vascular access devices and Fresenius Medical Care for chronic dialysis systems. The AngioDynamics BioFlo PICC and BioFlo Port (both trademarked) are the first ever antithrombogenic PICC catheters to gain FDA clearance. In-vitro blood loop results show that on average the BioFlo Port catheter had 96% less thrombus accumulation on its surface compared to non-coated conventional port catheters. In addition to Endexo technology, IBI has a rich pipeline of biomedical polymers that enable devices to deliver pharmaceuticals, small molecules, peptides and biologics. The next generation products take advantage of the simplicity of various chemistries and self-locating properties to proactively engage biological systems for drug delivery applications. More than a decade later, Dr Paul Santerre remains actively involved as chief scientific officer at Interface Biologics. In this role, he works with IBI employees, scientific advisors and industry partners to help move their innovative ideas from a polymer chemistry lab to clinical applications, ultimately improving patient outcomes and reducing costs for the healthcare system. Recent post market studies are substantiating the blood loop model in humans, by lowering the symptomatic DVT rate from on average 5% to 0.5%, which has saved the US healthcare system around US$1 billion. The company is currently enrolling a global multi-centre PROOF study desgined to show non-inferiority to the competition in a head-to-head comparison. Angiodynamics has expanded the partnership with IBI recently by licensing Endexo technology for both dialysis catheters and CVCs and aims to follow the success of the BioFlo PICC product by applying the technology in these product lines.

Irish Medical Technology Excellence Awards Celebrate Employment Growth

EVENTS AAMI Human Factors for Medical Devices Course Comes to Europe for the First Time UK-based technology and design consultancy Cambridge Design Partnership has announced that it has arranged with the Association for the Advancement of Medical Instrumentation (AAMI) to bring its highly acclaimed Human Factors for Medical Devices course to Europe for the first time. The course delivers practical usability engineering techniques that can be implemented in any medical device development programme. Importantly, it gives insights into creating usability submissions for both the USA and the EU regulatory regimes. The AAMI course not only addresses usability engineering itself, it also looks at the growing harmonisation between global standards and streamlining device submissions. With new guidelines about to be enforced in the USA, medical device companies worldwide need to be vigilant in understanding how to navigate these changing regulatory landscapes. If device development teams are not adequately trained in human factors processes and standards, safety critical use errors may be uncovered during validation, resulting in costly and untimely programme delays. The course, which will be held on April 13, 2014, at Heathrow Airport in London, UK, is aimed at anyone involved in bringing medical devices to the market. Well established in the US, ‘Human Factors for Medical Devices’ has always been considered as essential training for integrating human factors into the product development process, with many European companies travelling across the pond to attend. The course leaders are Dr Ed Israelski, who is the convener of international human factor (HF) medical standards with IEC and ISO and Dr Robert North, who is a co-author of the

The shortlist for the Overall Medical Technology Company of the Year Award is: l Abbott Diagnostics (Longford); l Aerogen Ltd; l Medtronic; and l Nypro Healthcare Ireland. << Cambridge Design Partnership founder Mike Cane. >> FDA human factors standards. The course will be the only event in Europe where companies can talk directly with an FDA representative. “Minimising the possibility of user error through usability engineering and good design practice is a critical part of developing safe and effective new products,” explains Mike Cane, founder, Cambridge Design Partnership (pictured). “We wanted to help make this course available to our healthcare clients and the wider medical device manufacturing community in Europe because we believe it is the best available.”

MEDICA AND COMPAMED 2013 VISITORS UP, DATES

Announced for 2014

ollowing growth in attendance for both the Medica and Compamed trade shows, held in November 2013 in Düsseldorf, Germany, the organisers have annnounced that next year’s Medica event will be held on November 12-15, 2014. Compamed will be on the first three of these days, November 12-14, 2014. With 681 exhibitors from 37 countries, the Compamed event set a new historical record in November 2013. The exhibitors presented to the some 17,000 visitors. According to the organisers, the undeniable trend among the displayed products was—enormous advances can be packed into the most highly

54/ MPN /NOVEMBER-DECEMBER 2013

Half of medical technology companies expect employee numbers to increase during Q4 2013, according to the latest survey results from the Irish Medical Device Association (IMDA). As many as 42% said they expected employee numbers to remain the same and only 8% said they expected a slight decrease. The survey findings have been published to coincide with the announcement of the shortlist for this year’s Medical Technology Excellence Awards. A total of nine medical technology companies have been shortlisted for the awards. At the time of going to press the events were taking place on December 12, 2013. The awards recognise and reward best practice in the medical technology sector in Ireland.

miniaturised components. Examples of this include micro-components and modules for tools used in minimally invasive surgery. Medica visitor numbers were up to 132,000 from 130,600 in 2012. “We have observed a growing number of visitors in recent years particularly from those emerging countries that are especially promising for the medical technology industry, namely from among Asian countries, from India, Russia as well as South America and China,” stated Joachim Schäfer, managing director of Messe Düsseldorf, the organisers of the events.

The shortlist for the Medical Technology Academic Award, encompassing the Emerging Medical Technology award, is: l Arann Technologies (Dublin City University); l BioInnovate Ireland; l Galway-Mayo Institute of Technology; l National University of Ireland Galway; and l University of Limerick. Commenting on the research findings Sinead Keogh, IMDA Director (pictured on page 36) said, “This research shows that medical technology companies in Ireland are continuing the growth trend, with many expecting employee numbers, total sales and productivity, to increase during the last quarter. These are signs that the industry is seeing strong performance and is well positioned into the future.” Andrew Vogelaar, Head of Medical Technologies, IDA Ireland said, “The research figures for R&D investment clearly demonstrate the long-term commitment that medical technology companies are making to Ireland. It is very positive for the sector and indicates that the positive momentum which we have seen over the past few years will be sustained going into 2014 and beyond.” Commenting on the shortlisted companies Colm MacFhionnlaoich, Manager Life Sciences Department, Enterprise Ireland, said: “The companies shortlisted showcase the very best of the industry and highlight yet again this year that those operating here in Ireland, both indigenous and multinational, are world class, innovative and leading the way.” The awards, sponsored by KPMG (platinum sponsor), Creganna-Tactx Medical and SteriPack (gold sponsors), were taking place in the Radisson Blu hotel in Galway.

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