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Medical Plastics News November-December 2012

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Welcome to the latest edition of Medical Plastics News. …

Welcome to the latest edition of Medical Plastics News.
Contents are:
5. Editor’s Letter: A thousand miles
As the MPN journey moves into its thrid year, I take a look back at the steps that brought us to where we are today, including the most recent Compamed and Medica shows in November 2012.

6. On the Pulse: Proposed regulation
The key changes in the 194-page European medical device regulation proposal are outlined. Also, news of the devices and diagnostics ally MedTech Europe.

11. The SPE: Supercritical CO2
Supercritical gases are being used as plasticisers, to improve processing of viscous high molecular weight polymers, and for injection moulding of foams.

14. Plastic Electronics: Smart switch
A report from Engel about moulding wipe-clean capacitive electronic switches by overmoulding film-based printed electronics. Also, news that resorbable electronics are a reality.

18. Materials: Bioresorbable polymers
US patent applications referencing resorbables have grown by 37% a year in 2005-11. Sam Anson investigates why. The article covers compounding, mechanical properties and degradation times, moulding and extrusion, additive manufacturing of resorbable tissue engineering scaffolds, Absorb—the first resorbable stent, Purac glass fibre composites, supercritical CO2 sterilisation, and coloration.


26. Folio: Liquid silicone
A low-viscosity, addition-curing silicone for soft compression effects.

29. Country Report: Germany
Germany is the European leader in innovation—second only to the USA in terms of patent registrations. The report is followed by a round up of medical plastics research institutions in Germany.

34. Cover Story: Micro matter
Pushing micro moulding boundaries with Accumold.

37. Design 4 Life: Licensed to Cure
Dassault launches dedicated medical device design sofware.

38. Modular Cleanrooms: A guide
Sean Fryers of Connect2Cleanrooms gives us a glimpse into the versatile world of modular cleanroms.

41. Doctor’s Note: Plastic and 3D Tomo
Machined plastics help physicists test performance of 3D digital breast tomosynthesis imaging equipment.

42. Pharmapack: Drug contact plastic
Interview with Steve Duckworth, head of medical and pharma at Clariant, about additives for cyclic olefins, extractables and leachables by Joy Harrison of Smithers Rapra, and “out of the box” packaging design from Team Consulting.

40. Events: Diary and VinylTec
Medical plastics diary in Q1 2013 and a review of SPE’s VinylTec conference in Chicago by Jodie Laughlin.


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  • 1. MPN MEDICAL PLASTICS NEWS M I C R O M AT T E R Pushing Moulding Boundaries with AccumoldALSO IN THIS ISSUE:Bioresorbable polymers ISSUE 9Plastic electronics November/December 2012Drug contact plastics at Pharmapack WWW.MPNMAGAZINE.COM
  • 2. MPN All Medical, All Plastics Contents 5. Editor’s Letter: A thousand miles 26. Folio: Liquid silicone As the MPN journey moves into its thrid A low-viscosity, addition-curing silicone year, I take a look back at the steps that for soft compression effects. brought us to where we are today, including the most recent Compamed 29. Country Report: Germany Editor’s Letter—page 5 and Medica shows in November 2012. Germany is the European leader in innovation—second only to the USA in 6. On the Pulse: Proposed regulation terms of patent registrations. The report The key changes in the 194-page is followed by a round up of medical European medical device regulation plastics research institutions in Germany. proposal are outlined. Also, news of the devices and diagnostics ally MedTech 34. Cover Story: Micro matter Europe. Pushing micro moulding boundaries with Accumold. 11. The SPE: Supercritical CO2Plastic Electronics—page 14-16 Supercritical gases are being used as 37. Design 4 Life: Licensed to Cure plasticisers, to improve processing of Dassault launches dedicated medical viscous high molecular weight polymers, device design sofware.Bioresorbable Polymers—page 18-25 and for injection moulding of foams. 38. Modular Cleanrooms: A guide 14. Plastic Electronics: Smart switch Sean Fryers of Connect2Cleanrooms A report from Engel about moulding gives us a glimpse into the versatile wipe-clean capacitive electronic switches world of modular cleanroms. by overmoulding film-based printed electronics. Also, news that resorbable 41. Doctor’s Note: Plastic and 3D Tomo electronics are a reality. Machined plastics help physicists test performance of 3D digital breast 18. Materials: Bioresorbable polymers tomosynthesis imaging equipment. Folio—page 26 US patent applications referencing resorbables have grown by 37% a year 42. Pharmapack: Drug contact plastic in 2005-11. Sam Anson investigates why. Interview with Steve Duckworth, head of The article covers compounding, medical and pharma at Clariant, about mechanical properties and degradation additives for cyclic olefins, extractables times, moulding and extrusion, additive and leachables by Joy Harrison of manufacturing of resorbable tissue Smithers Rapra, and “out of the box” engineering scaffolds, Absorb—the first packaging design from Team Consulting. resorbable stent, Purac glass fibre composites, supercritical CO2 50. Events: Diary and VinylTec sterilisation, and coloration. Medical plastics diary in Q1 2013 and a review of SPE’s VinylTec conference in Chicago by Jodie Laughlin. Online and in digital Medical Plastics News is available online, at www.mpnmagazine.com, and Pharmapack Preview—page 42-49 in digital (on the iPad, mobile phones and computers). NOVEMBER/DECEMBER 2012 / MPN /3
  • 3. MPN | EDITOR’S LETTER MPN | CREDITS editor | sam anson advertising | gareth pickering art | sam hamlyn A journey of a thousand miles Illustrating our achievements so far,begins with a single step. This phrase by Jesper Laursen of Danish compounder production | adrian priceChinese philosopher Lao Tzu, who died Melitek, said to me this month: “I sawin 531 BC and was a contemporary of your article about DEHP and wanted toConfucius, sums up very nicely where commend you on the result. You pulled subscriptions | tracey nichollsthings have come in the last 18 months together information from a lot ofat Medical Plastics News. interest groups which had the potential publisher | duncan wood The first step on the Medical Plastics to get very complicated. You reportedNews magazine journey was taken two the issues accurately, independentlyyears ago—in November 2010—when and carefully and this demonstratedI flew to Düsseldorf to visit the Medica your professional skills. You have shownand Compamed shows for the first that you are a proper journalist andtime. The trip was booked after I had MPN is a proper magazine.” Medical Plastics News is available on freepresented to my publisher the original Chris James of Monaco-based subscription to readers qualifying underidea for a magazine dedicated to medical plastics company Promepla also the publisher’s terms of control. Thosemedical applications for plastics. congratulated me. He said: “MPN fills a outside the criteria may subscribe at the I headed there with the goal of gap in the industry for plastic following annual rates: UK: £80making as many contacts as possible at manufacturers. It is highly relevant, the Europe and rest of the world: £115companies involved in the use of content is well researched andplastics for medical applications. I was insightfully written. Sam—yourpleased to find that the show was a knowledge of medical is impressive.” Medical Plastics News is published by:hotbed of advanced medical plastic Lao Tzu’s philosophy is helpful Plastics Multimedia Communications Ltd,technologies. because it encourages people to achieve Unit 2, Chowley Court, By the time I arrived at Compamed things that they would otherwise deem Chowley Oak Lane,the following year, our thousand-mile impossible. By breaking things down into Tattenhall, CH3 9GAjourney had well and truly begun. In the small parts, a task of a size or complexity T: +44(0)1829 770037preceeding twelve months, together too great to tangibly conceive instantly F: +44(0)1829 770047with my colleague Gareth Pickering, I becomes achievable. And this is a usefulhad developed and published three outlook on other aspects of work, as wellissues of a new medical device maga- as life in general.zine concept covering the medical © 2012 Plastics Multimedia << At Compamed 2012, Friedrich Communications Ltdplastics supply chain. The model enc- Echterdiek from moulder Spang &ompasses resin supply and pricing, While every attempt has been Brands shone a light on cost saving for made to ensure that the informationdesign and materials selection, machin- bag manufacturers, like investing inery and auxiliaries, processing methods contained within this publication is tooling for a twin shot cap design, accurate the publisher accepts noincluding moulding and extrusion, end reducing assembly steps andof line technology, regulation as well as liability for information published in simplifying manufacturing. Image error, or for views expressed. Allproduct focuses and clinician reviews. courtesy of PR Portfolio. >> A year on and I have just returned rights for Medical Plastics News arefrom my third Compamed and Med- reserved. Reproduction in whole orica event in a row. Being familiar with in part without prior writtenthe layout of the halls at Messe Düss- permission from the publisher iseldorf certainly helps make the most strictly prohibited.of the short time available at theevent. But representing what is now arecognisable brand in MPN is a big BPA Worldwideplus when lining up interviews with Membershipimportant industry representatives.Furthermore, our pledge of editorial ISSN No: 2047 - 4741 (Print)independence and technical accuracy 2047 - 475X (Digital)has clearly built a firm foundation oftrust and reassurance in the industry. NOVEMBER/DECEMBER 2012 / MPN /5
  • 4. INDUSTRY NEWS | Medical Device Regulation Europe’s Proposed Medical Device Regulation WORDS | SAM ANSON On September 26, 2012, the implementation of existing rules from one administration of the regulation and the European Commission issued a proposal member state to another as evidenced by scrutiny procedure related to high risk to overhaul regulations for medical recent reports by UK newspaper The class III implantable devices (see later). devices and active implantables. The Telegraph. It is also directed towards proposal document is 194 pages long addressing the problem related to post- Economic Operators and is a more stringent approach to market surveillance, highlighted recently by With a view to achieving better device regulation. It aims to bring about a the PIP silicone implants scandal, whereby transparency and traceability, Chapter II transparent and traceable supply chain competent authorities do not have sufficient sets out requirements for economic focusing on the life cycle of a broader mechanisms to monitor information and operators—manufacturers, authorised range of products. implement market surveillance. representatives, distributors and If implemented, being a regulation importers. The responsibilities of all Definitions rather than a directive, it will be applied “as economic operators are defined. is”, bringing consistency across EU states. There are more definitions in the Manufacturers and authorised The terms of the regulation itself areproposal document than the MDD—50 representatives must have an approved subject to change following discussion and compared with 14. The definition of a qualified person appointed who is an approval by the European Parliament. medical device has been expanded to expert in the field with qualifications. Once the final wording of the include aesthetic implantable devices (for There are also requirements placed on regulation is published it will enter into example cosmetic breast implants or non- the manufacturer with respect to force 20 days later and come into full corrective contact lenses) and invasive quantity-structure-property relationships devices used in humans with associated effect three years after that. Therefore, it (QSPRs), technical documentation, quality is likely to be at least 2017 before examples. management systems, post-market manufacturers are required to comply. surveillance plans and clinical follow ups Medical Device Coordination Group and labelling languages. Weaknesses of the MDD The proposed regulation would involve As far as distributors and importers are The new proposal aims to correct the establishment of an expert committee concerned, imported devices must bear weaknesses in the current Medical Device called the Medical Device Coordination the importer’s name on the device or its Directive (MDD). The biggest change Group, made up of members from EU packaging. There are requirements that concerns the oversight of notified bodies— states and chaired by the EC. The group importers must carry out sampling of which has led to inconsistency of will be responsible for marketed products while monitoring Former surgeon and Eucomed chairman October 9, “There has also been Dr Guy Lebeau (pictured) said: “I urge 2012 North heightened focus on all decision makers who want to make American Sales engineered polymers fundamental changes to the European such as co-polyether- October 10, system for medical devices to tread with of Medical ester elastomers 2012 caution. I fully agree that changes need Plastics to (COPE), polyether October 1, 2012 to be made to the current regulatory Grow by block amides (PEBA), Eucomed and EC Publishes framework but let’s make sure we keep 5.2 per cent a and acetal chemistries EDMA Launch Proposed medical the best system for patients and medical Year to 2018 that have more MedTech Europe, progress in Europe.” advanced performance a New Allied device Regulation properties for niche, Devices and technologically October 8, 2012 advanced healthcare Diagnostics Abbott Launches applications, such as Association tissue engineering and First Ever Fully implants,” said research Resorbable analyst Tridisha Vascular Stent Goswami. “These new “Abbott has remained committed to meeting the growing physician and patient materials will expand demand for a bioresorbable vascular scaffold—from the initial device the scope of plastic developed nearly 10 years ago to the expansion of our manufacturing polymers application capabilities to support this international launch,” said John M Capek, executive and propel the vice president, Medical Devices, Abbott. market.”6/ MPN / NOVEMBER/DECEMBER 2012
  • 5. ON THE PULSE complaints. Furthermore, these entities Notified Bodies Eudamed database registration is must declare that they have complied with Perhaps the greatest proposed itemised. The process for a post-market the requirements of the relevant clauses in change to the regulatory system surr- clinical follow-up is also explained. the proposed regulation document. ounds notified bodies and their metamorphosis from an industry partner Market Surveillance and Serious Additional Device Types into what Emergo describes as “a police- Incidents New devices to be included and like extension of the authorities’ market Under the proposal, manufacturers are specifically defined are: devices surveillance apparatus”. required to report a serious incident within incorporating medicinal product and Existing notified bodies will be subject 15 days. The EU database will be used to devices composed of substances or a to annual monitoring by authorities and share these reports to relevant bodies. combination of substances intended to an assessment once every three years by be ingested, inhaled or administered a joint assessment team. There are also Industry Response rectally or vaginally; devices incorporating new minimum requirements for notified In general, the proposal has been materials of biological origin; and bodies, set out in annex VI. welcomed by the industry. However, there software in devices and standalone The proposal also sets out terms for have been concerns that the proposed software. the so-called scrutiny procedure—how a scrutiny procedure for high risk class III notified body should notify the Medical devices is too tough and could stifle Eudamed Medical Device Database Device Coordination Group about new technological development and delay and Unique Device Identifiers (UDIs) implantable class III devices, including the device uptake—a key competitive edge of Chapter III proposes a process by which presentation of a Summary of Safety and Europe’s medical device industry at present. devices can be tracked within the EU. It Clinical Performance document created At the same time though, other consists of a newly established medical by the manufacturer. When explaining commentators have suggested that the device database—known as Eudamed— this requirement, Emergo pointed out proposal should be taken with a degree with a mandatory requirement on notified that many manufacturers may not have of political context. The Eucamed bodies, economic operators and member completed this document at this stage. database will require an increase in spend states to input data. A key component of Overall, the proposed legislation over by the European parliament and medical the system is the unique device identifier notified bodies is expected to be costly. devices may not be outside the current (UDI), a set of data which must be compiled climate of austerity for many member and submitted for every device sold in the Clinical Evaluation and Investigation states. Getting the funding for the EU market. It is proposed that class III As was generally expected, the roles proposal through parliament may not be devices will be separated out and subject to of clinical evaluation and investigation are as easy as many people think. a separate scrutiny procedure and, as part more prominent in the proposed of the data submitted, a summary of safety regulation than in the MDD. There are Credits: The above article was compiled using and clinical performance must be included. requirements quoting specific ISO information from medical device regulation consultants Emergo Group and Meddiquest. standards and guidance documents and“The [MedTech Europe] October 24, PREVIOUSLY ON MPNMAGAZINE.COMalliance not only signifies a 2012 ABHI 12:12:2012stronger and moreconsistent representation of Admits NotifiedEurope’s medical technology Bodiesindustry, but also provides October 23, 2012 Problemhealthcare stakeholders with October 31, “The PVCMed Alliance will actively Polycarbonate Followingone unified industry 2012 European communicate about PVC and its Producers Condemn Telegraph additives, its properties and itsdiscussion partner when Medical PVCneeded. Being able to speak French Proposed Ban Undercover essential contribution to quality Industry care delivery for healthcarewith one organisation about of Bisphenol A Reportmedtech issues should make Forms PVCMed professionals. It will also promote The European Information David Jones, director ofthe lives of healthcare Alliance innovative and environmentally Centre on Bisphenol A, a Communications at ABHI,players easier and makes friendly practices in PVC healthcare sub division of European said: “The Dailyindustry representation applications”, explains PVCMed plastics industry Telegraph’s investigationmore credible and Alliance spokesperson Brigitte Dero. association PlasticsEurope, into Notified Bodies (NBs)impactful,” said Serge comprises representatives highlights an issue that 24Bernasconi, chief executive from the main ABHI has raised withofficer of Eucomed, the polycarbonate producers authorities on a number ofEuropean Diagnostics in Europe—Bayer occasions. The control ofManufacturing Association MaterialScience, Dow, NBs across Europe has not(EDMA) and MedTech Sabic, Styron and been rigorous enough andEurope. Momentive. this must be improved.” NOVEMBER/DECEMBER 2012 / MPN /7
  • 6. 8/ MPN / NOVEMBER/DECEMBER 2012
  • 7. ON THE PULSE INDUSTRY NEWS | Devices and Diagnostics Industries Ally www.reforminghealthcare.eu website. The new report on Allied Medical Devices and value-based innovation focuses on how Europes medical technology industry is delivering on a promise of a Diagnostics Industry Group “Contract for a Healthy Future”. The updated industry strategy document, entitled Industry Strategy, Contract MedTech Europe for a Healthy Future, details the role of Europe’s medical technology industry in steering healthcare systems onto a WORDS | SAM ANSON sustainable path. Together with a third report by the Economist Intelligence Unit on Future-proofing Western On October 10, 2012, the The alliance will be Europe’s Healthcare, these reports are available as a free associations representing legally established by download on the reforminghealthcare.eu website.the European manufacturing the end of 2012 and The board of Medtech Europe will comprise three will collaborate closely industries for medical representatives from EDMA and three representatives on common policy devices, Eucomed, and from Eucomed. The chairmanship will rotate between its interest areas. All diagnostic devices, the members. The board will decide future topics of European medtech collaboration. European Diagnostics associations are invited Announced as a European Industry Alliance in January Manufacturers Association to join. 2012, MedTech Europe will work alongside its founding (EDMA), announced that Initially, MedTech members and will remain a separate entity, as will EDMA they had formed MedTech Europe’s focus will be and Eucomed. Medtech Europe is not an umbrella divided into five Europe, a new alliance association on top of Eucomed and EDMA. parts—legislative intended to encourage The three associations will be helmed by one chief frameworks for medical collaboration between the executive officer—Serge Bernasconi. Mr Bernasconi devices and in vitro succeeded the previous chief executive of Eucomed, two industries. The diagnostic (IVD) Luciano Cattani, and director general of EDMA Volker announcement was made at products; the European Oeding on July 16, 2012. the European MedTech medical technology Forum in Brussels, Belgium. industry’s five-year strategy; health << Serge Bernasconi is the technology assessment; patients and safety; and chief executive officer of environmental issues. the newly formed allied Medtech Europe has made a strong start to its role as Medtech Europe as well as an ally between the medical device and diagnostics Eucomed and the European manufacturing industries. It has published a new report on Diagnostics Manufacturers value-based innovation, updated an industry strategy Association (EMDA). >> document and overhauled the Reproduced with kind The Purpose of a Diagnostic Test permission of Eucomed. by Lluís Bohígas Santasusagna, director, institutional relations, Roche Diagnostics In vitro diagnostic (IVD) tests are being created for Screening consists of studying patients who do not yet home use, empowering patients with information about present any signs or symptoms of a specific illness in order their health and giving doctors the tools to optimise to find out if it has begun to quietly develop and if so, to treatments. be able to apply treatment as soon as possible. These tests Diagnosis is the process of finding out if a patient has are applied to large segments of the population and a specific disease. A medical professional prescribes a test should therefore be simple and cheap. to make a diagnosis or to exclude possible illness. The Prognosis allows clinicians to assess the likelihood a results are used to implement treatment or carry out patient has for developing a disease in the future and further tests. therefore take precautions earlier rather than later. Genetic Monitoring intends to see if the disease is controlled, tests, for example, analyse a patient’s predisposition for a purpose that is very common in chronic diseases such as developing a disease, allowing the patient and doctor to diabetes. Symptoms can be managed with medication, be more attentive to discovering early signs of the disease hormones or lifestyle changes. and to take preventive measures as needed. NOVEMBER/DECEMBER 2012 / MPN /9
  • 8. 10/ MPN / NOVEMBER/DECEMBER 2012
  • 9. ON THE PULSE Industry News from the SPE | Supercritical Fluids in Medical PlasticsSupercritical CO2 in BY DR SEAN LYONS, SENIOR SCIENTIST ATMedical Plastic Processing BAUSCH + LOMB, IRELAND The use of supercritical CO2 as a solvent in the CO2. Biomaterials as well as polyethylene and polystyreneprocessing of various biodegradable and biocompatible blends have exhibited similar behaviour.polymers for pharmaceutical and medical applications inthe forms of particles and microcellular foam has Plasticisationgarnered much attention in the last decade. A The use of supercritical fluids in the processing ofsupercritical fluid is defined as a substance for which both polymer melts can also lead to changes in the mechanicalpressure and temperature are above the critical values. properties of the materials. Most mechanical propertyThese fluids possess physicochemical properties— changes during processing can be attributed to theproperties which are both physical and chemical—such as plasticisation of the polymer by the supercritical fluid anddensity, viscosity and diffusivity. Density, viscosity and the resultant drop in Tg. Some blended polymer materialsdiffusivity are intermediate between those of liquids and have shown significant increases in modulus and strengthgases and are continuously adjustable from gas to liquid when formed in a supercritical fluid assisted process, this iswith small pressure and temperature variations. Both the often due to the tuning of the morphology and degree ofcapability of supercritical fluids to replace toxic solvents crystallisation of the material by the supercritical fluid.and the ability of tuning solvent characteristics for highly Changes in the elastic and creep modulii of materials whenspecific separations or reactions have led to the current processed with supercritical fluids can occur in a range ofscientific and industrial interest in supercritical fluids. A materials. However these changes and their magnitude aresupercritical fluid has the unique ability to diffuse through dependent on the solubility of the polymer(s) in thesolids like a gas, and dissolve materials like a liquid. CO2 is supercritical media and the supercritical material’s ability toa promising alternative to noxious organic solvents and induce crystallisation in the system in question.chlorofluorocarbons. It has shown versatility as asupercritical fluid in the synthesis as well as processing of Supercritical Fluids in Fibre Compositespolymers owing to its attractive physical properties. It is Polymer composites processing can also utilisenon-toxic, non-flammable, chemically inert and supercritical fluid technology and extensive research hasinexpensive. Its supercritical conditions are easily attained taken place in this area recently due to the burgeoning use(Tc = 304.15 K, Pc = 7.38MPa) and it can be removed of these materials in the electronic and medical industries.from a system by simple depressurisation. Companies such as Ireland’s SCF Processing have been pioneering research into bespoke industrial polymerA Processing Aid for Viscous High Molecular Weight processing solutions working with manufacturers toPolymers provide tailored materials processing transfer services. The processing of polymers is highly influenced by the Supercritical fluid can be used to carry the monomer ontoviscosity of the bulk materials. Raising the processing the fibres or particles to be used in the composite and totemperature or the addition of volatile or harmful act as a plasticiser for the synthesised polymer matrix whenplasticisers are often seen as solutions in overcoming the the composite is formed by in situ polymerisation of theinherent difficulties encountered when processing high monomer. Polymer composites can also be prepared bymolecular weight polymers. However, higher temperatures blending the polymer and the other component in theduring processing can lead to thermal degradation. Also, presence of supercritical media.added plasticisers remain in the product and thus alter itsproperties and performance. The low thermal stability of Microcellular Foam Productshigh molecular weight biodegradable polymers has led to The moulding of microcellular foam products, like manythe emergence of supercritical CO2 as a useful processing supercritical CO2 processes, entails the formation of a singleaid. There are many examples of the use of pressurised phase solution. On venting the CO2 by depressurisation,gases to lower the melt viscosity of numerous amorphous thermodynamic instability causes supersaturation of the CO2and semicrystalline polymers. Polyethylene glycol, dissolved in the polymer matrix and hence nucleation ofpolystyrene and polydimethylsiloxane are examples of cells occurs. The growth of the cells continues until apolymers where a viscosity reduction has been significant amount of CO2 escapes, the polymer passesdemonstrated upon the incorporation of supercritical Continued on page 13 NOVEMBER/DECEMBER 2012 / MPN /11
  • 10. Continued from page 11 ON THE PULSE through its Tg and the foamed structure 50%, reduced scrap rates, and lower Organisations Collaborate is frozen in place. An added advantage energy consumption (energy savings of this technology is that due to the are based on reduced processing on PVC in Healthcare lower pressures and softer fills, delicate temperatures and are process A new European association, items can be overmoulded without dependent); lower capital costs the PVCMed Alliance, has been much of the traditional displacement through the purchase of smaller and launched to promote the use and and resultant need for excessive control fewer machines, and fewer and less value of PVC in healthcare features. USA-based Trexel’s MuCell expensive moulds; reduced material applications. PVCMed is an process technology is said to have been costs through component density alliance of the PVC medical the first to widely offer microcellular reduction, thinner design, and material industry chain represented by foaming for both extrusion and injection substitution; and the ability to mould PVC resin and plasticiser moulding processes and as a result its thermoplastic parts that have a producers and PVC converters. technology is often licensed to substantially higher dimensional stability The alliance’s aim is to provide a industrial partners. Optifoam licensed which are free of warpage. focal point for communication with by Switzerland’s Sulzer Chemtech is an The use of supercritical fluids in the healthcare professionals and example whereby the supercritical fluid medical device sector affords the regulators about PVC-based dosing element is the nozzle of the opportunity to add a new and exciting healthcare applications, and their machine as opposed to the barrel. dimension to the processing of fundamental role in quality of Another example is Ergocell, the polymeric materials. Examples of healthcare, safety and cost- injection moulding process operated medical devices currently being efficiency, all whilst being by Japan’s Sumitomo (SHI) Demag for produced commercially using this environmentally responsible. the production of microcellular foamed technology include endoscopes, heart Through an interactive platform, products. The cycle sequences in the pumps, inhalers and nebulisers. The use Ergocell process essentially correspond of supercritical CO2 as an inexpensive the alliance seeks to consolidate a to the sequences in the standard solvent in many polymer processing strong dialogue with all involved injection moulding process. The applications has already brought many stakeholders to continue decisive difference is in the gas benefits to the industrial sector. As improving healthcare delivery delivery, which takes place usage becomes more widespread, together. simultaneously to plasticising. As the materials that had previously been “The PVCMed Alliance will screw draws in, melts and delivers designated as ‘un-processable’ due to actively communicate about PVC material into the space in front of the their high viscosity or their thermal and its additives, its properties and screw and—in the process—is being instability can now be reinvestigated its essential contribution to quality pushed back against the back pressure, with the aid of supercritical fluids. care delivery for healthcare gas is fed into the melt from a gas Supercritical fluid technology has not professionals. It will also promote metering station. Thus, the screw moves yet reached its potential within industry. innovative and environmentally back at a speed that is a function of the However, considerable research into friendly practices in PVC plasticising capacity of the screw. this field is ongoing which would healthcare applications”, explains Simultaneously, an amount of gas as indicate that the number of applications PVCMed Alliance spokesperson preset by the operator is delivered and the usage of this technology are Brigitte Dero. Ms Dero adds: “The into the melt. In contrast to the MuCell only likely to grow. Supercritical CO2 is quality and safety of PVC-based technology, which requires a modified also examined as a sterilant of healthcare applications guarantee screw assembly, the injection of the bioresorbable devices on pages 22-25. efficient and widely affordable supercritical fluid into a module Medical Plastics News would like healthcare systems to continuously downstream of a conventional to thank Austin Coffey of the Society improve and save patients’ lives.” plasticisation unit in the Ergocell of Plastics Engineers European At the time of going to press, technology means that it can be easily Medical Polymers Division for his help members of the PVCMed Alliance removed, allowing the injection with this article. include BASF, Colorite Europe, moulding equipment to be used in a Eastman, the European Council of conventional process when required. Vinyl Manufacturers (ECVM), OXEA, Renolit and Tarkett. Advantages of Supercritical Gas Assisted Injection Moulding The primary advantages of supercritical gas assisted injection moulding are: reduced operating costs through cycle time reductions of up to NOVEMBER/DECEMBER 2012 / MPN /13
  • 11. Electronics in Plastic Devices | Smart PlasticsAt the Touch of a Button:Wipe-Clean Moulded Switches for Medical Engineering For electronic medical devices, control Some people have earmarked smart plastics as a components such as switches and buttons converging technology where capacitive electronics have been combined with injection moulding. Others have must not only be easy to operate—they described them as a new type of composite technology. must also be easy to clean. They are Fundamentally, they consist of a plastic part moulded notorious for attracting germs and dirt over a film which has had electronic components printed particles, particularly in and around the onto it (see image below left). The result is an aesthetically pleasing part with smooth lines and a clean shiny finish. tiny crevices and gaps between the The part has electronically interactive parts built in to it to various components and connections. The form switches and buttons. development of smart plastics—moulded The electronics components consist of capacitive components with capacitive electronic sensors which utilise the principle of electrical capacity— the reciprocation between two spatial points (as in the functionality—offers device electric force field between two electrodes). The electric manufacturers the opportunity to flux lines within an electric field may be changed by develop wipe-clean electronic buttons introducing a conductive object (such as a fingertip). The and switches while improving production capacitive sensors pick up these changes and respond with a voltage variation that can be used to initiate a efficiency and achieving better and more particular function—such as an on/off or up/down complex designs. command. Since the field lines penetrate non-conductive solid bodies, the sensor effect also works from a distance through a thin surface layer such as a thermoplastic or an operators gloves. << Below: Sensors and conducting paths are printed onto the film; the malleability of the film gives product designers ample scope. >> << Above: Smart plastics represent new opportunities for the medical engineering sector, especially in the design of operator control units. >>14/ MPN / NOVEMBER/DECEMBER 2012
  • 12. PLASTIC ELECTRONICS The films can be configured in three dimensions and no assembly is required, productivity is also increased cut before being overmoulded or back-injected with sharply. thermoplastic. In this way, capacitive electronics can replace mechanical switches, buttons and control knobs. Pushing the Boundaries of Product Design The operating elements are covered by a continuous, Ample scope for design through injection moulding is even and highly resistant interface. a real benefit here. The flexible print production for the films makes it possible to position sensors almost Smart Plastics in Cars anywhere; films can also be formed into virtually any According to Austrian injection moulding machine shape. Sensitive surface technology is therefore the ideal manufacturer Engel, smart plastics have undergone most means by which to develop operator control units cost development in the automotive sector. Michael Fischer effectively—units that Engel say are unbeatable in terms (pictured right overleaf), sales manager (technologies) of usability and ergonomics. believes: “The cars of the future will be easier to operate than smartphones, simply by touch, feel and interaction.” At its open house in June 2012, Engel presented its first close-to-production application for smart plastics (see image). Centre consoles for cars with a sensitive interface were manufactured using an Engel duo 350 injection moulding machine with reversing plate and combination mould. A capacitive, three-dimensional pre-formed film was placed into the mould by a robot and overmoulded with PC/ABS. The component was then flow-coated with polyurethane to protect the surface and produce a high quality impression. << Injection moulding covers the electronic elements with a continuous and highly resistant plastic interface. >> Of course, ergonomics and cost-effectiveness have been key considerations in other sectors of industry for many years. With this in mind, a design study for the control panel of a washing machine was recently presented. Meanwhile, Engel and its partners are starting to field enquiries from the medical engineering sector. “I think the fact that this technology addresses a whole set of requirements at a stroke represents a major<< The manufacturing cell for centre consoles with capacitive opportunity for medical engineering”, says Christoph electronics delivers outstanding cost effectiveness. A high Lhota (pictured middle overleaf), the head of Engels level of automation—and the sensitive surface technology medical business unit. “Firstly were doing more to itself—are critical factors. >> address stringent hygiene requirements, secondly were improving the ergonomics of medical engineering The technology will now be marketed under the name products and thirdly were drastically cutting production Sensitive Surface by Engel and its project partners. “We costs. Pressure on costs is rising in the medical are in discussion with various automobile companies and engineering sector too.” OEMs with a view to mass-producing the first sensitive At present, lessons learned from the automobile surface applications in three to four years”, reveals Fischer. industry are being developed and applied to the medical In the case of vehicle construction, the hygiene engineering field. Alongside Engel, a company heavily aspects of a continuously sealed interface are less involved in the specialist development and production of important than ease of use and high efficiency in the intelligent, multi-layered interfaces is Austria- manufacturing process. Whereas conventional headquartered smart plastics technology developer manufacturing often involves the individual production plastic electronic. One key development issue at present is and assembly of more than 100 small parts, capacitive the sterilisability of intelligent electronic components. “We films and plastic granulate facilitate the production of successfully carried out function tests for the automobile functional, ready-to-install components in a single work industry in the temperature range of -40°C to +85°C”, step. “Taking the centre consoles as an example, reports Philipp Weissel (pictured left overleaf), CEO of production costs are reduced by at least 30% if we look at the whole process”, emphasises Michael Fischer. Since Continued on page 16 NOVEMBER/DECEMBER 2012 / MPN /15
  • 13. PLASTIC ELECTRONICS Electronics in Plastic Devices | Smart PlasticsContinued from page 15 plastic electronic. “Were now working on raising the Bioresorbable Electronic temperature range for critical applications in medical engineering.” Devices a Reality Upper Austria Hailed as Epicentre of Smart Plastics It’s not often that a doctor can claim two game- Evolution changing inventions in less than a year. That’s what Dr As far as the future research activity of Engel and Marvin J Slepian can boast, having developed a new class plastic electronic is concerned, Upper Austria promises of small, high performance electronics that are ideal conditions. Few places elsewhere in the world are biodragradable and capable of dissolving completely in such a high concentration of companies and research water or bodily fluids following a predefined period of institutes to be found alongside the infrastructure needed functionality. Earlier this year, Dr Slepian’s company, for smart plastics. Early in 2011, this density of specialist Syncardia—a US-based medical device manufacturer— expertise led to the foundation of a smart plastics developed and successfully implanted the first artificial networking group, the Smart Plastics initiative. The aim of plastic heart. In the 1980s, Dr Slepian developed one of this group is to accommodate the entire value chain for the first prototypes for biodegradable stents. intelligent electronic plastic products within Upper Dr Slepian is director of interventional cardiology and Austria so that world-leading system solutions may be professor of medicine at the USA’s University of Arizona developed in partnership. To further this goal, Smart (UA) Sarver Heart Center with a joint appointment in the Plastics is hosting a congress in Linz, Upper Austria—the UA department of biomedical engineering. He is also co- same place where Engel’s headquarters are—on June founder and chief technical officer of Syncardia. 10-11, 2013. Details of the technology on which this dissolvable electronic device is based—known as transient Editor’s Outlook electronics—were published in a September 2012 copy of Plastic electronics may help designers find an Science, a leading US scientific journal. alternative to conventional membrane keyboards in The paper describes a number of examples of transient medical situations. These membranes attempt to integrate electronic devices, including a system designed to monitor a continuous seal over an interface, but are said to be less and prevent bacterial infection at surgical incisions which than robust in practice and constitute a source of has been successfully demonstrated in rats. The paper was infection in sterile environments like operating theatres. written by Fiorenzo Omenetto, professor of biomedical Thanks to the commitment in Austria for smart plastics engineering at the Tufts School of Engineering in and Engel’s lead in the moulding expertise, observers can Massachusetts. Omnetto worked with researchers at expect product designers to turn to smart plastics for University of Arizona and Northwestern University in improved functionality, aesthetic design, not to mention Illinois. Materials found in conventional integrated circuits the wow factor of a highly sensitive button which requires are used—silicon and magnesium—but in an ultrathin form absolutely no pressure to activate. It takes the phrase “at that is then encapsulated in silk protein, which is the touch of a button” to a whole new level. dissolvable. Device dissolution is reportedly further controlled by sheets of silk protein in which the electronics are supported and encapsulated. Omenetto and his team have discovered how to adjust the properties of silk so that a wide range of degradation times can << Left to right: Michael Fischer, Engel sales be predetermined. manager (technologies), Christoph Lhota, Engel’s head of medical, and Philipp Weissel, Photo Source: CEO of plastic electronic. >> Beckman Institute, University of Illinois and Tufts University.16/ MPN / NOVEMBER/DECEMBER 2012
  • 14. Material Diagnosis | Growing Popularity of Bioresorbable Polymers Bioresorbable Polymers: Patents Growing by 37% a year WORDS | SAM ANSONBioresorbable polymers are nothing new. They trimethylene carbonate to form poly(glycolide-co- have been used in dissolvable sutures for a trimethylene carbonate), or (PGA-co-TMC). PGA degrades to form glycolic acid. number of years. But according to the United States Patent and Trademark Office database, Compounding, Mechanical Properties and the number of patents referencing Degradation Times bioresorbable and medical grew from 48 in The mechanical properties and degradation time of a bioresorbable device can be tailored to a specific2005 to 311 in 2011, an average annual growth application by adjusting the molecular weight, crystallinity rate of 37%, or 548% in absolute terms. In the and hydrophilicity of the polymer. This is achieved bylast two months, the first fully resorbable drug varying the percentage of polylactide D or L forms, andeluting stent was CE marked for sale in Europe. polyglycolide. Tony Listro, managing director of specialist US medical polymer compounder Foster Delivery Science Here Sam Anson looks at bioresorbable explains: “Compositions with higher hydrophilic and processing considerations while reviewing amorphous structures and a lower molecular weight examples of application success. resorb faster, yet often sacrifice mechanical strength. Conversely, higher crystallinity and molecular weight improve mechanical properties and decrease resorption Bioresorbable polymers, also referred to as rates.” bioresorbable or degradable polymers, are polymer Bone growth additives, such as tricalcium phosphate materials which can be safely absorbed by the body so (TCP) or hydroxyapetite acid (HA) can be melt blended that the materials from which a construction is made into these polymers to enhance bone growth during disappear over time. degradation. Additionally, the low melt temperatures of The following report examines bioresorbables from many bioresorbable polymers allows for melt blending the following perpectives—compounding, mechanical active pharmaceutical ingredients (APIs) for controlled- properties and degradation times; moulding and release drug delivery during degradation. However, extrusion; degradation testing; additive manufacturing of higher molecular weight polymers often require higher resorbable tissue engineering scaffolds; Absorb—the first melt temperatures and thus limit melt blending of some ever resorbable stent; Purac glass fibre composites; APIs with low degradation temperatures. supercritical CO2 sterilisation; and coloration. Twin screw extruders optimise bioresorbable polymer blending, including distribution and dispersion of additives. Polymer Types Due to the high cost of bioresorbable polymers, which can The most common bioresorbable polymer is polylactic often exceed US$1,000 per lb (US$2,200 per kg) and the acid (PLA), also known as polylactide, and is made from a relatively small nature of the implantable applications, small lactide monomer. Generally speaking, PLA is the main scale twin screw extruders—between 16 mm and 27 mm— building block for bioresorbable polymer materials. are ideal. Since these polymers begin degradation when Common derivatives of PLA are poly-L-lactide (PLLA), exposed to moisture, desiccant and vacuum driers are poly-D-lactide (PDLA) and poly-DL-lactide (PDLLA). required prior to melt blending. Unlike non-resorbable When in the body, PLA degrades into lactic acid, a non- polymers that are often water cooled upon exiting the toxic chemical which occurs naturally in the body. extruder in strand form, bioresorbable compounds must Polyglycolic acid (PGA), or polyglycolide (PG), is be air cooled. Pelletised strands destined for finished another type of bioresorbable polymer usually used for device processing must be thoroughly dried and properly bioresorbable sutures. The material can be packaged to prevent exposure to air moisture that can copolymerised with lactic acid to form to form poly(lactic- cause premature degradation. co-glycolic acid), or PLGA, with e-caprolactone to form poly(glycolide-co-caprolactone), or PGCL, and with18/ MPN / NOVEMBER/DECEMBER 2012
  • 15. BIORESORBABLE POLYMERSMoulding and Extrusion Considerations The processing of bioresorbable polymers must be Additive Manufacturing of Resorbable Tissuehandled with care. The materials themselves are highly Engineering Scaffoldshydrophilic, which is to say that they love water and will Additive manufacturing is being used to produceabsorb any moisture with which they come into contact. scaffolds for tissue engineering from bioresorbableUnless properly dry, the materials will not melt and polymers. A number of years back, researchers from Arecrystallise as expected, making moulding and extrusion Star, a leading Singaporean research institution,difficult. At the same time, bioresorbable polymers are successfully developed a technology for fabricatingsensitive to heat, and molecular structures can be damaged resorbable polymeric tissue scaffolds with high strengththrough exposure to excessive temperatures during drying. and porosity using additive manufacturing. Dr Margam With this in mind, careful and thorough drying at low Chandrasekaran (Chandra), now CEO and chief scientisttemperatures is needed, while the humidity of the at Singapore-based tissue engineering scaffoldprocessing environment must be considered. manufacturer Bioscaffold International, was one of the Knowing the melt and recrystallisation behaviour of lead inventors of the technology. Along with a team ofbioresorbable materials is important, as is understanding clinicians at the National University of Singapore, at A Starthe melt flow viscosity. Often materials will have a low Chandra developed an application of the technology tomelt temperature, a high crystallisation temperature and produce a commerical product for high strengthgenerally be extremely viscous—like hot honey—except resorbable dental scaffolds usingat a small temperature range between the two. This additive manufacturing.means that there is a very small temperature range at Chandra explains: “Wewhich materials can be processed—that is to say, the used a combination of PLGArange at which the material is molten, at which the with PVA and changed theviscosity is at the right level for injection moulding or binder used in the 3Dextrusion, and at which the material won’t crystallise printing process toprematurely. produce parts in a Due to their delicate molecular structures, desired shape andbioresorbable polymers are limited in terms of the amount then used a postof time they can remain molten, so cycle times must be processing techniquekept within this range, which is often not very long. similar to particulate leaching to strengthen theDegradation Testing of Bioresorbable Medical structure. In fact, besidesDevices PLGA, we did work on << The 3D–Bioplotter from On November 28, 2012, the FDA held a public PCL, PLA and PGA. A EnvisionTec is specially designedworkshop on the testing of bioresorbable medical paper was published in to process a large range ofdevices at its White Oak campus in Silver Spring, 2007 in the Journal of materials, from hard polymers,Maryland, USA. Materials Processing and through ceramic pastes to soft The workshop, entitled Workshop on Absorbable Technology.” hydrogels including cells. >>Medical Devices: Lessons Learned From Correlations of Today, Chandra’sBench Testing and Clinical Performance, was co- company manufactures implantable tissue engineeringsponsored by ASTM (American Society for Testing and scaffolds for dentists made from PLGA. The scaffolds areMaterials) International, a US organisation responsible for used by dentists to preserve tooth sockets followingthe development and delivery of international voluntary removal of a tooth. The implant encourages bone growth,consensus standards for engineered products, including thereby preserving the socket while the gums heal. Thismedical devices. means that any further restorative procedures, such as The purpose of the workshop was to provide a forum dentures or implantable false tooth fittings, are vastlyfor highlighting and discussing the use of bioresorbable improved.materials in medical devices across a broad range of Another resorbable scaffold application,indications with the aim of defining successful and manufactured in the USA by tissue engineering deviceunsuccessful methods to predict clinical performance. pioneer 3D Biotek, is a three dimensional PLGA-based The main topics discussed included identification of degradable porous cell culture device for medicaltest methods for establishing correlations between in research processes. The device is special because itsvitro and in vivo degradation of absorbable implantable three dimensional nature allows cells to grow in threedevices, and the interaction of mechanical loading and dimensions. Its 100% porous nature allows cells to bemechanical performance with degradation. While there seeded very easily. Because PLGA is biocompatible, thewas an emphasis on cardiovascular indications as part of a scaffolds, with or without cells, can be implanted intopanel session, characterisation techniques and animals. Degradation time is approximately 4-5 months.experiences from both cardiovascular as well as non- Germany-headquartered 3D printer suppliercardiovascular devices were discussed and encouraged. Continued on page 20 NOVEMBER/DECEMBER 2012 / MPN /19
  • 16. BIORESORBABLE POLYMERS Continued from page 19 the degradation rate govern this performance. EnvisionTec’s 3D-Bioplotter is an all-purpose direct The potential long term benefits of a scaffold that manufacturing tissue engineering machine for the dissolves are significant. The vessel may expand and production of hard and soft scaffolds from biomaterials, contract as needed to increase the flow of blood to the cells as well as synthetic materials. It is specially designed heart in response to normal activities such as exercising. to process a large range of materials, from hard polymers, Treatment and diagnostic options are broadened. The through ceramic pastes to soft hydrogels. need for long-term treatment with anti-clotting According to EnvisionTec, the 3D-Bioplotter is medications may be reduced. And future interventions specially designed for work in sterile environments in a would be unobstructed by a permanent implant. laminar flow box, a requirement of biofabrication, for “This innovation represents a true paradigm shift in example when using alginate cell suspensions for the how we treat coronary artery disease,” said Patrick W construction of cell-laden scaffolds. Additionally, the 3D- Serruys, a medical doctor and professor of interventional Bioplotter can use up to five different tools per job. This cardiology at the Thoraxcentre, Erasmus University means that scaffolds fabricated using the 3D-Bioplotter Hospital, Rotterdam, the Netherlands. He added: “With can have up to five different materials, or five different the launch of Absorb, a scaffold that disappears after types of cells in specific positions. doing its job is no longer a dream, but a reality.” In contrast to other rapid prototyping techniques the Absorb is now available in a broad size matrix to 3D-Bioplotter, EnvisionTec says, uses a very simple and support the needs of physicians treating patients with straightforward technology, invented in 1999 at the CAD. There are 7 sizes available—varying in length from Freiburg Materials Research Centre in Germany. The 12 mm to 28 mm and in diameter from 2.5 mm to manufacturing process works by air pressure being 3.5 mm. The strut thickness and width are approximately applied to a liquid and liquefied material, which solidifies 150 μm and 180 μm respectively. upon dispensing. At the time of going to press, Absorb is neither The 3D-Bioplotter is delivered together with a PC approved nor authorised for sale and currently is in workstation which operates and monitors the system. After development with no regulatory status in the United States. transferring the 3D CAD data to the PC it is processed by the Bioplotter’s software package. The preprocessed data << The backbone of is then transferred to the 3D-Bioplotter using a network Absorb, the first connection. The Bioplotter software monitors the working fully resorsable drug process until it is completed. eluting stent, is produced by Abbot Launches First Ever Bioresorbable Vascular extruding PLLA into Scaffold a tube and then USA-headquartered Abbott, one of the worlds radially and axially leading medical device OEMs with 91,000 employees, has expanding that tube launched Absorb, the first fully resorbable drug eluting in a process which is vascular scaffold. similar to stretch Absorb is available for use by clinicians in treating blow moulding. The coronary artery disease (CAD) across Europe, Asia Pacific tube is then lasered and Latin America. It works by restoring blood flow to the to produce the heart—similar to a metallic stent—but instead of being scaffold pattern. >> permanent it dissolves into the body. After dissolution it leaves behind a treated vessel that may resume more Bioresorbable Glass Fibre Composites for Load natural function and movement because it is free of a Bearing permanent metallic stent. In August 2012, Netherlands-based bioresorbable In order to create the backbone of the device, PLLA polymer manufacturer and owner of the Purasorb brand resin is extruded into a tube, then radially and axially of medical resorbable polymers Purac acquired FiberLive, expanded in a process that resembles stretch blow an advanced resorbable glass fibre composite technology. moulding. The scaffold pattern is then cut with a laser, and The acquisition included the intellectual property of the the finished product is coated with a drug and polymer FiberLive technology and its key personnel. mixture and crimped onto a catheter before being According to Purac, FiberLive is a unique patented packaged and sterilised. composite consisting of a matrix of resorbable silica- According to Abbott, PLLA has an intrinsic degradation based glass fibres and resorbable polymers, forming an rate that is influenced in vivo by very few factors. Device exceptionally strong resorbable composite material—up performance over its degradation lifecycle is tuned to to six times stronger than cortical bone. This unique match physiological requirements for vessel support. The composite material widens possibilities to use resorbable polylactide molecular weight in the finished product and Continued on page 2220/ MPN / NOVEMBER/DECEMBER 2012
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  • 18. Material Diagnosis | Growing Popularity of Bioresorbable Polymers Continued from page 20 (PDLLA), polyglycolide (PG), polycaprolactone (PCL)— and copolymers L-lactide/DL-lactide (PLDL), materials into the fields of bone fixation, where in the past L-lactide/D-lactide (PLD), L-lactide/glycolide (PLG), L- it has been impossible due to a lack of load-bearing lactide/captrolactone (PLC) and DL-lactide/glycolide properties of conventional biopolymers. The material can (PDLG). The company also offers custom synthesis of be used in different kinds of orthopaedic treatments, bioresorbable polymers. including craniomaxillofacial (skull and jaw), sports medicine, trauma and spinal procedures. When commenting on the acquisition, Menno << Implantable Lammers, managing director Purac Biomaterials, said: “This resorbable screws technology will be a game changer in the orthopaedic made from Purac resorbable market, where load bearing properties are FiberLive. >> needed. The FiberLive technology is the strongest fully resorbable material available for human implants, with strength up to six times higher than cortical bone, comparable to metal. For decades Purac Biomaterial has been the leading company in the field of medical Supercritical CO2 Sterilisation of Bioabsorbable resorbable polymer materials having strong commitment Polymer Devices and enthusiasm towards innovation and development in A team of researchers at NovaSterilis, a supplier of the field. With the acquisition of this innovative supercritical carbon dioxide (scCO2) sterilisation resorbable composite material we are able to further technologies and equipment based in the state of New widen our capabilities to serve our customers according York, working with Dr Chih-Chang Chu, a professor from to their requirements.” Cornell University (Ithaca, NY), have developed a novel The Purasorb brand of resorbable polymers covers a process for sterilising devices made from bioresorbable broad range of grades, including polymers—poly-L- polymers using scCO2. The technology is being distributed lactide (PLLA), poly-D-lactide (PDLA), poly-DL-lactide in Europe by European Medical Contract Manufacturer22/ MPN / NOVEMBER/DECEMBER 2012
  • 19. BIORESORBABLE POLYMERS(EMCM) based in Nijmegen, The Netherlands. inactive, which means that when the spore is killed, there According to a poster presentation from the team is little or no effect on the delicate surrounding material.displayed at the Ninth World Biomaterials Congress in Sterilisation can be done inhouse as there are lowChina in June 2012, which reported the feasibility of capital expenditures required, meaning that deviceNovaSterilis’s scCO2 sterilisation method for an manufacturers can retain full control and sight of theirabsorbable suture, scCO2 is preferable to ethylene oxide products during sterilisation. Furthermore, the time takenwhen sterilising bioresorbable devices for a number of for this method is much shorter than traditional ethylenereasons, as follows. oxide—according to NovaSterilis president and CEO Devices can be processed at low pressure and David C Burns, “you are talking minutes to hours rathertemperature, which reduces costs and energy requirements. than hours to days”.Low temperature processing makes it ideal for specialist Residual chemicals are non existent or negligiblebioresorbable devices due to their highly sensitive following sterilisation. Any that do remain are non-toxic asmolecular structure (as explained earlier). Furthermore, the confirmed by toxicity testing.CO2 molecule has a low surface tension which also reduces ScCO2 sterilisation is a new technology. The first 510kthe likelihood of damaging delicate molecular structures submission is expected within the next 12 months. Fourcommonly found in bioresorbable materials. companies are currently using the technology to sterilise The fact that scCO2 sterilisation can be used to allograft tissue because of its gentle effect on collagensterilise in between the pores of a material—it is said to (biopolymer)—three in the USA and one in Australia.penetrate deeply into a substance—plays perfectly into According to David C Burns, president and CEOthe hands of bioresorbable polymer devices as by their NovaSterilis: “Today’s highly technical products requirevery nature they are very porous. The poster points to very specialised handling, including sterilisation in smallerthe fact that spores can live in the pores of the material batches. Moreover, the desire to maintain custody ofand the method can get right between the microscopic product is more important to many of our customers.”holes to ensure they are completely sterile. Furthermore, The NovaSterilis scCO2 process is said to be safe forreinforcing the delicate nature of the method, the scCO2 many polymers, allograft tissues, plastics, and surgicalcan penetrate inside the spore and oxidise it to render it Continued on page 25 NOVEMBER/DECEMBER 2012 / MPN /23
  • 20. BIORESORBABLE POLYMERS Continued from page 23 as doxycycline antibiotics and cell growth substances. metals. NovaSterilis manufactures 20-litre and 80-litre fully The process whereby these granules are made is an automated, computerised, and network capable inhouse developed proprietary process of DS. The sterilisation units. Designed with a small footprint, these materials start out as soft porous granules of tricalcium units are ideal for biomedical material companies that phosphate (TCP). Then using a sintering process, the require high value and flexibility. NovaSterilis provides granules are hardened and coated with PLA before being supportive technical services, assisting customers to packaged into easy-to-use kits ready for orthopaedic determine if this process is appropriate for specific surgeons. products, establishing cycle times and developing Tissue fixation implants are injection moulded validation and regulatory plans. degradable PLA-based components for fixing tissue in In 2007 NovaSterilis won the Presidential Green place during surgery. Processed by closely controlling Chemistry Challenge Award Presented by the US cycle times and temperatures, DS manufactures a range of Environmental Protection Agency. devices, including cages for spinal applications, knee interference screws, small pins for foot surgery, implants<< This is a highly magnified scCO2 for cranioplasty and suture anchors for shoulders. In this sterilised Dexon suture, area, the company offers full device development and manufactured by USA- manufacturing services, including design and headquartered device development, manufacturing, packaging, sterilisation, manufacturer Covidien. registration as well as development and manufacture ofNote the scale—100 μm— the instruments required for application. on the left hand side. The image is courtesy of Dr Coloured BioresorbablesChih-Chang Chu of Cornell Visibility of small transparent implantable devices can University’s Department be difficult intra operatively. Coloured devices can of Fiber Science and support precision and quality control of the surgeon. Apparel Design. >> Bioresorbable colours are another product offering of DS. The company is an expert at integrating FDA approved Profile of a Bioresorbable Expert: Degradable implantable colours into bioresorbable devices. The issue Solutions, Switzerland with pigments in implantable devices is that there are very Degradable Solutions (DS), based in Switzerland, few suppliers of biocompatible colours. DS has secured manufactures a number of bioresorbable products. The the supply of compliant pigments. company is a spin-off from the Swiss Federal Institute of Technology Zurich (Eidgenössische Technische Hochschule Zürich—ETH) and was taken over in November 2011 by Swiss oral care device manufacturer Sunstar Group. It is a technological leader in its field and has extensive experience of working with bioresorbable polymers. Two areas of interest are bone graft << Degradable Solutions, substitutes and tissue fixation devices. based in Switzerland, has Bone graft substitutes are sold under the brand name developed granules (left) of easy-graft and are the company’s most important resorbable tricalcium product. Easy-graft consists of resorbable granules of phosphate coated with PLA. calcium phosphate which have been coated with When mixed with an polylactic acid. The granules are injected into parts of the activator liquid the granules body where bone needs to grow, particularly broken form a sticky putty which can be injected (above) into bones and teeth. An activator liquid is added to the the body before setting to form a bioresorbable porous granules just before injection. The activator causes the bone cement that allows bone to grow in and around it polylactic acid coatings to form a sticky putty which allows as it degrades slowly over time. >> the granules to be applied directly through a syringe. When in contact with blood, the biomaterial solidifies << Degradable Solutions is and forms a defect-analogue, mechanically stable mass of also an expert injection material which is porous and will be replaced by bone moulder of resorbable tissue over time. materials. This screw, This occurs thanks to the fact that the calcium Sysorb, is a patented phosphate degrades over time, allowing bone cells to turbine shaped screw head grow in and around the calcium phosphate granules as for reconstruction of the they degrade. DS is also talking about incorporating cruciate ligament. >> active pharmaceutical ingredients into the material, such NOVEMBER/DECEMBER 2012 / MPN /25
  • 21. FOLIO This wonderful image was sent to us by Germansilicone manufacturer Wacker. The image is one ofthe company’s latest silicone rubber grades formedical applications marketed under the Silpurantrademark. This particular grade, Silpuran UR 34xx,is a low-viscosity, addition-curing silicone rubbersuitable for use in medical applications requiring asoft compression effect. Two viscosity levels areavailable: 25,000 mPas (Silpuran UR 3420) and15,000 mPas (Silpuran UR 3440). The productconsists of an A and a B component, is easy toprocess and cures at room temperature. Silpuran products are said to be highly pure,free of organic plasticisers and stabilisers, and havepassed selected tests for biocompatibilityaccording to ISO 10993 and US PharmacopeiaClass VI. They are manufactured in accordance withWacker’s own inhouse clean operations standard,and are filled and packaged under cleanroomconditions. Furthermore, specific Silpuran siliconerubber grades are also suitable for long-termmedical applications. Potential applications cover abroad range and include port catheters, voiceprostheses, gastric rings, and pacemakers throughto disk, joint and hearing implants.
  • 22. GERMANY Profile of the German Medical Technology Industry WORDS | SAM ANSON In terms of innovation, there is little doubt that Germany is the compared with €20 bn in 2010. Despite the deceleration, 2011 wasEuropean leader in medical technology. The country is the third a better year than 2009 when revenue fell by 4.3% to €18.3 bn duelargest supplier of medical technology products and associated to dampened demand for Germany’s medtech exports.services in the world and in terms of new patent registrations it is A breakdown of revenues into domestic sales and exportssecond behind the USA. shows that at €14.2 bn, exports during 2011 were up compared In 2009 the German government successfully implemented with 2010 by 10.6% while domestic sales grew by a slow 0.4% tocompulsory health insurance. In 2011 it distributed photographic €7.2 bn. As a result exports as a percentage of total revenues, atelectronic health cards to facilitate treatment. 66%, was higher than the norm of 60-65% and far higher than the German medical technology companies achieve approximately approximate rate in the 1990s of around 40%.one third of their revenues from products which are less than In 2010, exports rose by 12% to a total of €12.8 bn whilethree years old. On average, medtech companies invest a large domestic sales rose by 5%.share, around 9%, of their revenues in research and development. As a medical technology market, the country is third largest in German Medtech Export Marketsthe world after the USA and Japan and is by far the largest in Germany’s largest export destination is the EU, which in theEurope—twice the size that of France and three times those of third quarter of 2010 accounted for around 40% of totalItaly, the UK and Spain. Germany’s share of global medtech sales medtech exports. The EU is followed by North America with ais estimated to be 11%. The US and European markets, by share of 20%, Asia with 17% and the rest of Europe (non EU) withcontrast, take a share of 41% and 30% respectively. 11%. The fastest growing market for German medical technology companies in the third quarter of 2010 was Latin America with aThe Market for Medical Devices in Germany 28% increase compared with the corresponding period a year Germany’s total spending on medical devices and related earlier, followed by Asia with a 26% rise. Despite being one ofservices (excluding investment goods and dental prostheses) is the hardest hit regions by the global slowdown, sales to Northcurrently at a total of around €25 billion a year. A further €1 bn America rose by a healthy 13%.is spent on dressings and bandages, which are grouped underdrugs. A Geographical Snapshot of the German Medical Technology SectorThe Medical Technology Industry’s Revenues A large proportion of the industry is concentrated in south Growth in revenue generated by the German medical Germany, primarily in the federal states of Baden-Württemberg andtechnology sector slowed to 6.9% in 2011 from 9.4% in 2010, Bavaria. There are 350 companies with more than 20 employees inaccording to official statistics. In 2011, revenue totalled €21.4 bn these states and impressively, these firms account for more than half of the total turnover achieved by the entire German sector.<< Germany’s catchment area Approximately a quarter of revenues are generated by medicalby air, rail and road. >> technology companies in Hessen, the state which contains the city Frankfurt, Germany’s northernmost state Schleswig-Holstein, North Rhine-Westphalia—the state in the west whose capital is Düsselforf and largest city is Cologne, and the state of Berlin. << Concentration of German medtech companies with more than €5 mn turnover. >> Continued on page 30 NOVEMBER/DECEMBER 2012 / MPN /29
  • 23. GERMANYContinued from page 29 strong industrial base in Germany, primarily in the small and medium sized family owned company sector.Employment in the German Medical Technology Sector In Vitro Diagnostics: In-vitro diagnostics (IVDs) consists of According to recent estimates, the medical technology instruments and apparatus (including software) which are usedindustry employs approximately 175,000 workers. This total together with reagents for the laboratory or on-site examination ofconsists of more than 100,000 people at 1,250 businesses which samples which originate from the human body. They provideemploy more than 20 employees and 75,000 employees at information specific to physiological or pathological states, congenital10,000 businesses with 20 employees or less. A further 29,000 defects, recipient tolerance levels, and therapeutic conditionemployees work in sales of medical and orthopaedic goods. monitoring. In this context, important innovative subareas include lab- Medical technology in its narrower sense employs 137,000 on-chip technology, molecular diagnostics, immunodiagnostics,people in Germany, according to a study on the health satellite decentralised diagnostics, and individualised medicine.account published by the Federal Ministry of Economics. For the Prostheses and Implants: Important areas in this field includeyear 2005, the Fraunhofer Institute for Systems and Innovation technical aids for the disabled and rehabilitation products,Research ISI calculates that the number of indirect employees of neuroprosthetics and functional electro simulation devices, as wellthe medical technology sector was at 68,000. This means that each as intelligent and nano and bio-functionalised implants.job within the industry provides another 0.75 jobs in other sectors. In terms of industry structure, prosthesis and implant During the years 2000 to 2008 the number of employees in innovation is largely carried out by small and medium sizedthe medical technology sector in Germany rose by 12%. By companies. The sector is also characterised by a wide range ofcomparison, over the same period the number of employees in technology which stretches from simple mechanical systems tothe pharmaceutical industry decreased by 4%. complex, active implants. As much as 15% of the medtech employees work in research Telemedicine and Model Based Therapy: Telemedicine,and development, also with an upward trend. or telehealth, is the name given to diagnostics and therapy Apart from a few large companies, the medical technology measures which make use of telecommunications to bridgesector consists mostly of medium sized businesses. As much as location and time distances between doctors and patients or95% of all businesses have fewer than 250 employees. In 2010, between consulting doctors.the 1,065 medtech companies in Germany with fewer than 250 E-health refers to specific concepts, ways of thinking,employees provided jobs for around 54,000 people. approaches and obligations towards networked and global The rate of inflation in labour costs in Germany is among the thinking for the improvement of healthcare using informationlowest in Europe and is stable with an average of just 2.0% a year and communications technology (ICT).during 2000-08. By comparison, the average inflation in the Key themes and particularly innovative subdivisions includetwenty seven nations which make up the EU was 1.7 percentage electronic patient records, telemonitoring, expert systems,points higher than in Germany at 3.4% while in the UK it was ambient assisted living, and virtual reality in medicine.4.9%, in the Netherlands it was 3.8% and in France it was 3.4%. Imaging Systems: In addition to classic imaging procedures The reason given for Germany’s competitive labour supply is a (x-ray, computer tomography, magnet resonance tomographyhigh rate of productivity and steady wage levels. German and ultrasound), new methods such as positron emissionproductivity rates are almost 10% greater than the average of the tomography (PET) and single photon emission tomographyEU’s 15 core nations and almost 25% higher than the OECD average. (SPECT) are gaining in importance. Other important innovations include screening and earlySpecialisms of the German Medtech Industry diagnostics, therapy monitoring, molecular imaging, multimodal The German medtech sector covers a wide range of product systems, image guided intervention, 4D functional imaging, andcategories—from high end specialist devices to commodity items image and data processing. Wide ranging financial measuresfor general healthcare provision. A wide range of experience in supporting the development of imaging procedures have beeninternational markets means that products can be easily tailored put in place by the German government.to international customers requirements. Device and System Networking in Healthcare Settings: In a study entitled The Identification of Hurdles to Investment In most application areas today, medical technology devices tend toin the Medical Technology Sector, published in 2008, the be operated as individual devices. However, the linking of medicalGermany’s Ministry of Education and Research identified some technology devices to systems and their incorporation into hospitalkey developmental trends in the sector. IT infrastructure is on the increase. This integration is creating new Operational and Interventional Devices and Systems: possibilities in therapy and process optimisation terms.This area of innovation includes devices and procedures for Moreover, it also provides a complete picture of the patient’soperational interventions on the human body, meaning direct, medical history, the procedures undertaken and their current status.manual or instrument based interventions. By comparing the progress of previously evaluated standard Key themes and particularly innovative subareas in this field procedures with the progress of the current operation, it isinclude minimally invasive surgery, robotics and navigation in possible to acquire information about its subsequent progression.surgery, surgical instruments, and intensive medicine. With a workflow analysis of this kind it is possible, for In addition to this, networking concepts in the context of instance, to determine the forecast ending of the operation andinteroperable devices and systems play as much of a specialist therefore arrange the scheduling of the next patient in optimumrole as simple and intuitive ease-of-use. A specific feature is the and timely fashion.30/ MPN / NOVEMBER/DECEMBER 2012
  • 24. R&D | Medical Plastics in Germany German Medical Plastics As German medtech firms continue to enjoy widespread growth, a commitment to innovation is blindingly obvious in the medical plastics sector. The country enjoys the second highest number of patent registrations in the world after the USA. Medical plastics are not an outlier in this statistic. To find out who is leading innovation in medical plastics we spoke with plastics engineer and independent consultant with twenty years experience Monika Verheij. “When looking at German innovation in medical plastics, the first places to look are the research institutes,” says Monika. “Near Nuremburg we have two very important research institutions which are working with medical plastics to develop innovative applications. SKZ— Süddeutsches Kunstoffzentrum (South German Plastics Centre)—is involved in a good deal of medical plastics research.” An example of some of the areas in which SKZ is involved is non-destructive testing (NDT) of test cracks in medical plastics led by Dr Kurt Engelsing. “The University of Erlangen’s Institute of Polymer Technology (LKT—Lehrstuhl für Kunststofftechnik) is another leading plastic research institute with strength in medical” Monika advises. “I met << The president of Rosenheim University of Applied Sciences, Prof Heinrich Köster (left) and Dr Karlheinz Bourdon, vice president of KraussMaffei at the time of the opening of the university’s cleanroom competence centre. >>32/ MPN / NOVEMBER/DECEMBER 2012
  • 25. GERMANYResearch Community representatives from there at a recent SPE [Society of Plastics Institute, headquartered in Munich. RWTH stands for Reheinisch- Engineers] European Medical Polymers conference at Queen’s Westfaelische Technische Hochschule—the Rhein-Westphalia University, Belfast,” she added. Institute of Technology. Rosenheim University of Applied Science, where Monika actually studied, is notable in terms of its expertise with medical Medical Technology Trade Shows plastics. On January 29, 2010, the university opened what it calls While there are no trade shows dedicated to medical plastics a cleanroom competence centre, kitted out with KraussMaffei (unlike the UK where Mediplas debuted in September 2012), injection moulding machines. Led by Prof Peter Karlinger, there is a biannual medical plastics conference, Kunststoffe in der students and academic researchers are able to explore future Medizintechnik, organised by the German Association of possibilities for cleanroom moulding. Engineers—the VDI. “I met Prof Peter Karlinger at Fakuma 2012,” said Monika. “He Germany hosts the largest plastics trade show in the world— is in the SPE’s network of plastics engineers.” K, short for the German word for plastic Kunstoff—every three The university at Rosenheim has had a longstanding years. In the two years when K is not taking place, the Fakuma association with KraussMaffei’s—one of Germany’s leading show in Friedrichshafen, a much smaller but still sizeable manufacturers of injection moulding machinery. The machinery dedicated plastics trade show, opens its doors. installed at the competence centre in 2010 includes an EX As regards medtech suppliers events, there is always a strong 80/380 all-electric injection moulding machine and an integrated contingent of plastics exhibitors at both the country’s leading IR 50 F/K industrial robot. For its role as a laboratory machine, the medtech trade shows—Compamed in Düsseldorf every EX is equipped with a number of measuring systems capable of November and Medtec in Stuttgart every February collecting data on over 100 parameters, including performance, or March. torques and pressures. Monika Verheij serves on the board of directors Other German research institutes of note are RWTH Aachen of the Society of Plastic Engineers European on the Dutch border west of Düsseldorf and the Fraunhofer Medical Polymers Division. NOVEMBER/DECEMBER 2012 / MPN /33
  • 26. Making Materials Work | Talk to Your Moulder Before Calling it Quits Micro Matter: Thin Wall Aspect Ratios, Multiple Component Parts and End of Line Growing interest in micro moulding technology, especially within the medical device community, has prompted many questions in the marketplace. What do you need to know about micro moulding? How is it different from traditional moulding? Are there any guidelines? Considering these questions, micro moulding experts at USA- based Accumold have written below, hoping to shine a light on these issues for design engineers and product developers. << These parts are moulded According to US micro moulding experts Accumold, in one step from two simple answers to these questions are difficult to give. materials—a hard There are subtleties and complexities which often can transparent outer ABS and a only be engineered through experience. In its basic form, soft TPU ring measuring just the micro moulding process is very similar to standard 2.4 mm across. >> moulding. It still requires the ability for the mould to open and close. There still needs to be a place to gate, eject and split the part, and concepts like draft and aspect ratio are very much still in play. Where the process starts to divert from conventional “Keep the creativity maximised; moulding and what makes these questions difficult to the impossible is done every day.” answer is the fact the each and every project can bring its own set of complexities on the micro scale. When dealing with micro sized parts how you approach elements like the design, material selection, gate and/or parting line basically insisting that each part design and material locations can be the difference between success and choice can have its own set of rules. failure. Knowing how to approach each of these requires The other main barrier to the success of this study was a high degree of expertise and experiences not when resin experts were asked which materials would run necessarily readily available in the marketplace. a 42:1 aspect ratio at 76 μm all of them said none. Resin material data sheets are often consulted to understand Thin Wall Aspect Ratios: Beyond Material Data Sheets what the melt flow characteristics and what gate sizes may The company recommends a general guide of a 6:1 be recommended. The problem is that most of these aspect ratio when it comes to applications like thin wall data sheets are developed by studying a much larger moulding. However one recent Accumold study on the part design and gate size. In fact most gate size relationship of material choice to feature performance recommendations are larger than many micro moulded demonstrated that some materials in a thin wall section part themselves. This is why Accumold recommends you (76 μm) only ran with an aspect ratio of 3:1 while others consult with your micro moulder before calling it quits on ran at 42:1. The wide variety in the response makes it a project you are told is not producible. Hands on difficult to give a hard and fast rule on aspect ratio when experience with processing high temperature dealing with such small features. This was also one mould thermoplastics at the micro scale beyond what the data in one situation with optimal design. Other designs may sheet may imply is often essential to the success of a or may not perform the same way with any given material project.34/ MPN / NOVEMBER/DECEMBER 2012
  • 27. MICRO MOULDING << The parts on the red background are an overmoulded fabric mesh. The delicate fabric is automatically articulated through a four- cavity mould where it is cut then encapsulated in plastic. >> << This image demonstrates the range of parts available from Accumold. >>Multiple Component Moulding End of Line—Inspection, Measurement, Assembly Another key aspect when designing for micro and Cleanroom Packagingmoulding is knowing what other processes or value added When in the early concept phase of a project it cancomponents are available. When space is a factor, interest be easy to overlook post-moulding processes. Sometimesin multiple component parts or even part consolidation part handling can be equally or more difficult than theranks high. Processes like lead frame moulding, insert mould build itself. Making the small part may be missionmoulding, two-shot moulding or overmoulding are one, but delivering it in a manufacture-ready fashion canenabling technologies and opening up a vast array of be a whole new challenge not to be taken lightly. Thepossibilities at the micro scale. However, adding the inspection, measurement, packaging, and/or cleanroomadditional complexities to what may be an already processing of a part that’s only 800 μm long can be morecomplicated situation requires a tremendous amount of difficult than meets the eye. If your incoming inspectionpre-design work and design for manufacturability. can’t validate the specification or your manufacturingWorking with your experienced micro moulder at the schemes can’t manipulate the part successfully you’ve notconcept stage is ideal for situations like this. really finished. Don’t overlook the backend of the Traditionally one might wait until there is a part to process; it’s not always as easy as other, larger parts youquote before approaching a moulder. The more complex may have moulded in the past.the project, the earlier in the design phase the better. As a rule, reach out to your micro moulder as youMany times a system will have to be custom built or the embark on any project you feel will require expertiselead strip will have to be designed to the moulder’s beyond a traditional supplier. Know that micro mouldingspecifications so that it can articulate through the mould, is more than the size of the press one may have. It takespossibly even be die-formed or singulated to make the years of experience and a high level of expertise to pullfinal desired part. off the most complex of projects. And most importantly A true micro moulder can overmould all sorts of keep the creativity maximised; the impossible is donemetals, plastics, fabrics, glass, flex-circuit or another every day.delicate medium. In a general sense, most items that can Accumold is situated in Ankeny in Iowa in the Midwestwithstand the temperatures and pressures of moulding region of the USA. It serves markets worldwide. Thecan be overmoulded. Keep in mind, whatever it is to be company developed their micro moulding process andovermoulded needs a way to be held in the mould while techniques more than 25 years ago and is solely dedicatedbeing processed. This is an often overlooked but a to pushing the limits with micro technologies. For morenecessary part of the design process. information on the company visit their website www.accu- mold.com. For more details on their reports or case studies click on Corporate Resources on the home page. NOVEMBER/DECEMBER 2012 / MPN /35
  • 28. DESIGN 4 LIFEDassault Launches Dedicated One Quarter of Supply Chain Has ImprovedMedical Device Design Software Business Performance and Growth, Study Concludes France-headquartered software Embedded Regulatory Conceptsdeveloper Dassault Systèmes has launched Licensed to Cure allows companies toa new product for medical device eliminate scattered processes and data,manufacturers called Licensed to Cure. and to embed regulations as an asset, Based on Dassault Systèmes’s optimising quality and compliance and3DExperience design software, Licensed reducing cost and time to market.to Cure is said to help accelerate the During the first half of 2012, marketdelivery of innovative, safe and fully Single Source of Information research and analysis firm Cambashicompliant medical devices. Licensed to Cure ensures a single performed a survey of the medical According to Dassault, Licensed to source of information that allows device and life science manufacturingCure ensures a single source of manufacturers to always get relevant, up- sector and their suppliers. The surveyinformation for innovation, as well as a fully to-date information and establish true was carried out in association with USA-transparent and documented change collaboration with the same, accurate set based UBM Canon Medical Deviceprocess allowing medical device of product data. Media Group and sponsored by Frenchmanufacturers to optimise resource design software developer Dassaultallocation, maximise IP reuse, and Automated Tasks Systèmes. In a white paper summarisingstreamline the regulatory filing process. By Licensed to Cure automates the survey results, one of thecreating an end-to-end, traceable, and “bureaucratic” tasks and ensures conclusions drawn was that a quarter ofcompliant product development process procedural enforcement that leads to respondents were enjoying growththat is directly linked to quality making products right the first time, while making major improvements inmanagement, medical device speeding time to regulatory approval. their business performance. The papermanufacturers can expedite time to market has drawn a profile of theseand minimise regulatory overheads. Structured Process and respondents, which Cambashi describes “An increasing regulatory scrutiny is Documentation as Advancers.putting pressure on medical device Licensed to Cure provides structured Advancers, the survey says, focus onmanufacturers to achieve total quality and process and documentation such as what customers care about whilesafety,” said Monica Menghini, executive “living” design history files (DHFs) and innovating aggressively. At thevice president, industry and marketing, device master records (DMRs), bringing operational level they have improved inDassault Systèmes. “With the number of full traceability and automated reporting manufacturing, planning andFDA warning letters issued on the rise, the and filing. development. They have implementedtime and budget that manufacturers spend measurement, production andon regulatory activities is increasing. Our Innovation Pipeline management processes and a wide3DExperience platform, with dedicated According to Dassault, Licensed to Cure variety of information systems.industry solution experiences, enables helps medical device manufacturers The report also pulls forward somecompanies to manage their business accelerate and increase the innovation of the strategies that appear to beobjectives in a complex regulatory pipeline to sustain market expansion in new effective to achieve specific goals and toenvironment while meeting consumers’ countries and with specialised products to balance trade-offs. For example, mostexpectations for safe products.” meet patient needs without limits from risk respondents believe they conduct more In terms of individual elements, the mitigation and regulatory restrictions. quality process checks than arenew software has a range of new features. required, which is inefficient. To help focus on this and not only grow but also << The screenshot improve profitability, companies must gives an idea of measure and improve not just their the specialist quality but the cost of quality and the medical device cost of compliance. related features The white paper is available for of the Licensed to download from the Dassault Systèmes Cure design website www.3ds.com. software. >> NOVEMBER/DECEMBER 2012 / MPN /37
  • 29. MODULAR CLEANROOMSThe Versatile World of Modular Cleanrooms BY SEAN FRYERS, MARKETING MANAGER AT CONNECT2CLEANROOMS A cleanroom is a room in which the concentration of airborne Benefits of Modular Cleanrooms: Lean Manufacturingparticles is controlled and which is constructed and used in a Demand for modular cleanrooms is on the increase as moremanner to minimise the introduction, generation and retention of processes, particularly in the medical plastics sector, are benefitingparticles inside the room. from a cleanroom environment. With this demand comes a cost Modular cleanroom constructions are typically built as and companies are obviously going to look for the best solution tofreestanding, solid and robust structures suitable for use for fit their needs and budget. Due to recent years of cut backs thatinjection moulding, extrusion and thermoforming environments. many industries have witnessed, small, medium and largeThey are designed to be an alternative to static cleanrooms. organisations have had to re-think their company strategies and A modular cleanroom will use standard off the shelf proprietary become leaner in the way they manage processes. Modularcomponents that when combined with the customer’s cleanrooms are part of that leaner way of thinking, as contractrequirements will create a 100% bespoke room, thus reducing cost manufacturers are finding they can dramatically increase their scopeand lead time. Examples of customer requirements include specific of work by introducing cleanroom facilities.ISO classification, lighting and whether they want a hard or soft wall. With traditional build cleanrooms, retrospective modifications Modular cleanrooms use air filtration technology to reach the are often a lengthy and costly process, so future demands must berequired cleanroom classification. The two main types are high accounted for in the initial specification. Modular solutions areefficiency particulate air (HEPA) or ultra-low penetration air (ULPA) more flexible as expansions and relocations can be accommodatedfiltration. Filtration creates an exceptionally clean environment. much more easily. In these uncertain times companies are seeingHEPA filtration is able to remove particles as small as 0.3 μm while the fact that they can stagger their investment to grow with contractULPA can handle those as small as 0.1 μm. Variable speed wins or developments as a real benefit.adjustments means that air changes in the room can be changed as Dramatic design improvements have also led to an increasedrequired—maintaining quality but giving the flexibility to benefit demand for modular cleanrooms. The use of clear, solid wall panelsfrom reduced energy costs during off peak times. has led to an improved perception of the modular design of cleanrooms. They are no longer seen as the temporary, low budgetCleanroom ISO Classification option and now offer a reliable and robust alternative to the A cleanroom can be designed to achieve various ISO 14644-1 traditional build cleanrooms.classifications of air cleanliness. ISO 14644-1 is the internationalstandard for air cleanliness for cleanrooms and associated Hard or Soft Wall and Entrance Controlcontrolled environments. Modular cleanrooms are available as hard and soft wall options. Often, the type of product being manufactured will dictate the Hard wall modular cleanroom options are manufactured from clearISO classification required. Long term implantable products need polyethylene terephthalate. This material is aesthetically pleasingto be manufactured in a cleanroom with a higher standard of air yet limits access to the cleanrooms while allowing in light andcleanliness than non-sterile products which are used outside the ensuring that processes can be overseen.body. The main rule of thumb is to consider your process, Softwall options are also aesthetically pleasing, ensure minimumdetermine the quality that you need to achieve using industry opening only when entering or exiting the cleanroom, maintain theregulatory guidelines and if in doubt, speak to a reputable integrity of the room and are a low cost investment. A modularcleanroom company to gain professional advice. cleanroom can be housed within a dirtier area, for example a warehouse, and still maintain their ISO integrity.Selected Airborne Particulate Cleanliness Classes Tacky mats outside the cleanroom remove dust particles from The standard ISO 14644-1 defines the various classifications for footwear and changing rooms can be built within the modularcleanrooms. The main criterion for classification is the maximum cleanroom to ensure that the user can change into cleanroomconcentration of airborne particles up to a certain size per cubic apparel in a controlled environment prior to entering themetre of air. In medical plastics, typically the most stringent cleanroom.cleanroom class found is up to ISO class 5 while typically the least By including a mid-height rail to a softwall cleanroom enclosure,stringent is class 8. In a class 5 cleanroom, the maximum number of you can direct people to aparticles permitted per cubic metre of air is as follows: 100,000 of a dedicated entrance andsize which is greater or equal to 0.1 μm, 23,700 of a size which is prevent people fromgreater or equal to 0.2 μm, up to just 29 of a size which is greater entering the cleanroom at anythan equal to 5 μm. A class 8 cleanroom, by contrast, doesn’t point thereby maintaining fullidentify particles smaller than 0.5 μm and allows up to 29,300 control of access. Mid heightparticles greater than 5.0 μm in size. rails also offer extra strength to soft wall cleanrooms.38/ MPN / NOVEMBER/DECEMBER 2012
  • 30. Bespoke DesignVarious cleanroom solutions can be offered to fit the manydifferent processes offered within the medical plastics sector. Themodular design creates a localised clean area which offers asolution that can be tailored to suit each organisation’s specificmachinery. A fixed ballroom design with no internal supports, allowscleanrooms to be designed to house large machinery with accesspanels located in the ceiling. These panels can be removed to allowa crane travelling above the cleanroom access to the machinery inthe cleanroom. Localised or part coverage of a machine by a cleanroom isoften used when a specific area of the process needs to achieve acleanroom standard. This can be, for example, at the packaging endof a machine where the product would have to be transferred andpacked in an environment where particle reduction would beimperative. Whole coverage of a machine by a cleanroom is also acommon prospect which can unearth interesting variables such asthe height of a robotic arm housed on top of an injection mouldingmachine. The advantage of a modular cleanroom is that it can bedesigned in such a bespoke manner that all variables are moreoften than not catered for. High performance cleanroom solutions can be designed to beintegral to the machine in the form of air conditioned laminar flowhoods that can feed cool, particulate-free air onto the machines.The airflow over the injection moulding tool can be kept at apredetermined cool temperature to ensure that condensationdoes not harm the processes.Summary Whatever cleanroom solution is chosen, an investment is beingmade which will have to be looked after. Regular validations of acleanroom are recommended to ensure that it is achieving thecorrect ISO classification. Correct processes and proceduresshould be carried out, and cleanroom apparel should be worn,cleanliness should be maintained with appropriate lint-freecleanroom wipes and cleaning solutions. Stainless steel furniture isalso available for cleanrooms to reduce particle output. Acleanroom should become an integral part of production and withthe correct maintenance, care and attention it can open newopportunities, diversifying offerings. << Left to right: Installations of modular cleanrooms in Holland, Latvia and the UK. >> NOVEMBER/DECEMBER 2012 / MPN /39
  • 31. DOCTOR’S NOTEMachined Plastics Help PhysicistsTest Performance of 3D Digital BreastTomosynthesis Imaging Equipment Over twenty years ago a national breast screening programmewas established in England and Wales which invited all womenaged between 50 and 70 to have their breasts screened for cancerevery three years. The programme saves approximately 1,300 livesa year at an annual cost to the UK’s state-funded National HealthService (NHS) of £96 mn. Recently, critics have said that the programme has led to overdiagnosis. The screening technology highlights cancers, some ofwhich may not have caused a problem if they had not beendetected. However, in some cases, the risks associated with thishave not been properly explained to patients before they startedtreatment. Putting criticisms to one side, the NHS is a pioneer in cancerscreening technology. Breast screening was one of the first nationalscreening programmes and the process has been taken up byhealthcare providers in other countries. The commitment by the NHS to breast screening over the last20 years or so has supported the development of advanced X-rayscreening technologies. Most recently, the advent of state-of-the- << Carville manufactures a number of phantoms for theart three-dimensional digital breast tomosynthesis (DBT), also UK’s state-funded National Health Service (NHS). One ofknown as 3D tomo, is helping clinicians achieve even more accuracy the specialist skills here is the inclusion of aluminiumduring scanning. balls positioned to the nearest 0.1 mm using Carville’s Implementing DBT scanning equipment in UK hospitals diffusion bonding process. >>requires type testing—the process of comparing and testing thetechnical performance of different systems before recommendingthey be used in addition to conventional imaging technology intrials to evaluate their clinical effectiveness. arranged in a square grid arrangement in the centre of the acrylic In order to test the equipment, operators use phantoms—flat plate. The balls are arranged 55 mm apart in a rectangular array,acrylic plates which are designed to mimic the properties of the the distance being accurate to within 100 μm (0.1 mm). The reasonbreast tissue—to ensure that the equipment is functioning properly for specifying this precision in positioning the balls was so that thebefore the x-rays can be taken. images could be used to evaluate geometric distortion. A UK-based team of research physicists at The Royal Surrey Carville is able to achieve these high levels of accuracy byCounty Hospital in Guildford, UK, are in the process of type testing encapsulating the balls between two plates and then bonding thenew DBT machines. The team is part of the UK’s National Co- two plates together using a proprietary diffusion bonding process.ordinating Centre for the Physics of Mammography. According to Carville, the process ensures a seamless joint as if the They are using phantoms manufactured specially for 3D DBT phantom was produced as a solid block. The dimensions of themachines by UK-based plastics machining expert Carville. Carville phantoms are 300 mm x 240 mm x 5 mm.have supplied phantoms to the NHS for 2D equipment as well as These phantoms are being manufactured by Carville now andradiology delivery devices for many years. will be used by 13 regional health authorities in England and Wales The phantom used for the 3D equipment is made from a cast later this month.acrylic. Acrylic is ideal for the phantoms because it has very similar Carville has also manufactured a block of acrylic containing justattenuation characteristics to human tissue and can be used in one aluminium ball with a diameter of 1 mm. The single ball in thevarious thicknesses—between 20 mm and 70 mm—to simulate block allows radiographers to test a feature with a particular densityhuman tissue when x-ray performance is being calibrated. and shape in order to perform a regular check on their The acrylic is stressed and fully normalised (heat treated) to tomosynthesis images.remove this internal stress. The material is then diamond machined Medical Plastics News would like to thank Celia Strudley at theand polished to produce clear flat plates. The latest acrylic Royal Surrey County Hospital NHS Foundation Trust in Guildford,phantoms contain 25 aluminium balls with a diameter of 1 mm Surrey, UK. NOVEMBER/DECEMBER 2012 / MPN /41
  • 32. Drug Contact Plastics | Cyclic Olefin Additives Colours and Additives for Cyclic Olefins Enable High Tech Bioactive Drug DeliveryInterview with Steve Duckworth, head of medical and Sam Anson: And what about Clariant’s Masterbatch unit?pharmaceutical at Clariant’s masterbatch unit. Steve Duckworth: On our stand, number 333, we will be focusing on our recently introduced range of Mevopur USP/ISOThe overlap in technologies across traditional compliant additives aimed at improving the final product or the productivity.medical instruments and drug delivery devicesis gaining prominence. Healthcare providers Sam Anson: I heard that you are working closely with Topas andare on the look out for more innovative their cyclic olefins. Can you tell me a little more about this?mechanisms from drug companies to allow as Steve Duckworth: Topas cyclic olefin copolymer is a verymany patients as possible to treat themselves interesting material from a number of stand points but particularly its clarity combined with rigidity. It is clear like glass. This makes itfrom home, thereby saving hospital ideal for the replacement of glass in syringes or ampoules.expenditure. Being inert, durable, low cost,lightweight and colourable, plastic is the Sam Anson: I was told that syringe and ampoule manufacturersmaterial of choice for designers of these have the biggest appetite for cyclic olefins. What is driving this?mechanisms, particularly as new biotech drug Steve Duckworth: Demand is being fuelled by three factors. First, there are safety concerns related to breakages of glass-basedformulations enter the realm. Ahead of next syringes during transportation. The Topas olefins are shatterproofyear’s Pharmapack show in Paris on February so there’s more durability there. Second, the fact that plastic13-14, Medical Plastics News interviewed Steve syringes and ampoules can be injection or blow moulded givesDuckworth, head of medical and opportunities for reduced costs while maintaining high clarity. Third, injection moulding also gives options for designers to beginpharmaceutical at Clariant’s Masterbatch unit. to think about newer and more intricate shapes.Sam Anson: Looking at the name Pharmapack in a literal sense,readers might be forgiven for thinking that the exhibition is only for Sam Anson: According to a report published by USA-basedtraditional packaging products like drug blister packs, fluid bags consultancy firm Greystone Research Associates in April 2012,and disposable films. But they’d be wrong wouldn’t they? demand for prefilled syringes is expected to grow at double digitSteve Duckworth: Absolutely. The show is more important than rates to 4.75 bn units in 2016. The report says that cyclic olefins arethey might initially realise. Despite the name, approximately half of a “material to watch”. How is Clariant helping to supply thisthe people there are involved in drug delivery devices. And it’s demand?really worth visiting. Being in Paris, the show attracts people from all Steve Duckworth: Working with Topas, we have developed aover Europe. And it’s a really nice format too. number of standard colorants and additives for cyclic olefins. Two to note are our UV filters in amber and pink and our additiveSam Anson: You’re not the first person to recommend it. What which can prevent yellowing following up to two rounds of gammacan visitors expect to see there from Clariant? sterilisation. Both technologies have been developed from triedSteve Duckworth: Clariant will have two stands. A team from and trusted technologies.Performance Packaging, part of the Functional Materials businessunit—formed following Clariant’s acquisition of Süd Chemie in Sam Anson: Tell me about the UV filtering first.2011—will be there to talk about desiccant and barrier packaging Steve Duckworth: Some contents of prefilled syringes andsolutions used in both primary packaging of pharmaceuticals and ampoules, particularly new ‘biologic’ products can be highlysecondary packaging products for drug delivery devices, which sensitive to light and thus need to be protected using a coloranthelp protect sensitive products from oxygen and water which filters out UV light. Clariant already manufactures a range ofdegradation. USP grade amber and pink colorants for polyolefin-based ampoules and syringes. We have worked with Topas and have developed USP/ISO pre-tested pink, amber and other colours42/ MPN / NOVEMBER/DECEMBER 2012
  • 33. PHARMAPACK 2013which can be used with cyclic olefins to filter out different parts ofUV light, depending on the customer’s requirement.Sam Anson: And the yellowing preventing additives?Steve Duckworth: Some polymers, and particularlypolypropylenes and cyclic olefins, undergo a yellowing effectunder gamma or e-beam sterilisation. Clariant offers a USP/ISOgrade additive that counteracts this yellowing effect to maintaincolour and clarity.Sam Anson: You mentioned that repeat sterilisation is a particularproblem. Tell me more.Steve Duckworth: We know that there is a demand frommanufacturers to offer products which can be repeat sterilised, asend users wish to have the option to re-sterilise devices. Inaddition, even with a single sterilisation, if problems areencountered during the process, the sterilisation may be repeated.As part of a radiation study, we sterilised three grades of Topasmaterial at 0, 25, and 50 kGy to determine the amount of additiverequired to reduce the colour shift. As a result we can now offer aMevopur additive for protection of up to two cycles of gamma ore-beam sterilisation of devices made from cyclic olefins.Note: Topas cyclic olefins are usually used for one sterilisation cyclebut should a manufacturer need to repeat a gamma cycle due to a << At Pharmapack 2013 Steve Duckworth will be talkingline malfunction for example they can do so without issue from about Clariant’s Mevopur range of USP Class VI approvedClariant’s gamma testing. That said, Topas do not recommend additives and colorants, including those which arerepeat sterilisation in general. compatible with Topas’s cyclic olefin copolymers. >>Sam Anson: Fascinating. That’s advanced thinking. As a leadingsupplier of colours for plastics, you must have a privileged view of bright colours to safely differentiate between the two pens tohow things are changing in this area for USP/ISO materials. minimise the risk of a mix up.Steve Duckworth: I do. And things are changing quickly. Just overa year ago I said to Medical Plastics News that I thought colours are Sam Anson: What additives are you offering which help plasticcoming. And that trend is certainly showing no signs of abating. For processing?example colour coding has become a key aspect to device design, Steve Duckworth: A popular product range is our USP/ISO laserparticularly in drug delivery. For example a new generation of additives for marking and welding that comes with USP Class VIinsulin treatment offers patients the opportunity to only require a compliance. Of particular interest is the welding additive. It allowssingle daily injection, replacing insulin which required three or more clever things to be done with the design, offers more reliability thandoses a day. The insulin is typically self-administered by a adhesives and eliminates the potential problem of residues. Also asconvenient pen device However, manufacturers are concerned part of this range we offer UPS/ISO nucleants to help reduce cyclethat despite labelling, patients may mix up these devices and time, optimise wall sections and solve production problems.mistakenly give themselves an insulin overdose by injecting thesingle dose more than once in a day. Their solution to this is to use Clariant will be at Pharmapack on stand 333. NOVEMBER/DECEMBER 2012 / MPN /43
  • 34. PHARMAPACK 2013Understanding Chemical InteractionDuring Material SelectionBY JOY HARRISON, PRINCIPALCONSULTANT AT PLASTICSTESTING AND ANALYSISCONSULTANCY SMITHERSRAPRA, UK.Source: Topas. There are many factors to take into account in choosing the right plastic material for pharmaceutical packaging applications and successfully converting it to the finished product. Joy Harrison summarises the main considerations for producing packaging of appropriate quality which compliments the pharmaceutical product. Continued on page 47 NOVEMBER/DECEMBER 2012 / MPN /45
  • 35. 46/ MPN / NOVEMBER/DECEMBER 2012
  • 36. PHARMAPACK 2013 Drug Contact Plastics | Extractables and LeachablesContinued from page 45 The key requirements for Furthermore, in Europe, as the REACH Process according to thepharmaceutical packaging materials are regulations continue to change, awareness manufacturer’s guidelines and avoidthat the packaging contains, protects and and careful selection of the plasticiser material degradation at all costs.prevents deterioration of the system is essential. Remember that the material probably haspharmaceutical product during storage, a reduced stabiliser package compared totransportation and possibly in use. Sterilisation standard grades.However, the packaging material must not Sterilisation of the packaging is Contamination by other materials mustcause any adverse effects to the sometimes required. Radiation, steam and be avoided. This may arise after changingpharmaceutical substance which render it ethylene oxide techniques are commonly materials in the moulding equipment.less effective in its function or render the used. Irradiation is preferred as it is much Production in a cleanroom is oftenproduct harmful. quicker but is another potential source of deemed necessary and many moulders material degradation. Ethylene oxide is offer this service.Understanding Interactions Between more innocuous to the plastic packaging Where sterilisation is required, select athe Plastic and the Pharmaceutical but can leave harmful residues. plastic type that will withstand the chosen The most important consideration is Manufacturers of polymer resins and sterilisation technique or select athat there should be no chemical reaction compounds for packaging are, of course, technique that is compatible with thebetween the pharmaceutical substance aware of these issues. Grades of material plastic to avoid excessive degradation.and the packaging material. Developers are produced, with reduced or tailored Carry out extractables and leachablesmust ascertain that there is chemical additive packages, specifically aimed at testing on the moulded product incompatibility and stability over the applications which are in contact with contact with the pharmaceuticalproduct’s shelf life at the stated storage pharmaceuticals, as well food and medical substance. The material supplier may beconditions. devices. Superior resistance to irradiation able to advise which substances must be Interaction between the may be another feature. These grades are quantified.pharmaceutical substance and the usually subjected to additional qualitypackaging materials can take several controls and have undergone extensiveforms, some more obvious than others. testing. These materials may be In the most severe case, the substance recognised by FDA food contactmay attack the packaging material such compliance or USP 88 Class VI claims. Smithers Raprathat the integrity of the packaging is In addition, processing may change the Forecastsbreached. Such a material would be plastic material. For example if the materialclearly unfit for purpose. is overheated during processing, Medical Plastics The substance may attack the degradation substances may be produced Market Growthpackaging, causing plasticisation and which are toxic or carcinogenic in nature In a new report published bysoftening of the packaging, leading to and therefore extremely undesirable. Smithers Rapra, sales of medicaldimensional instability. In addition the plastics are forecast to grow rapidly,packaging material could contaminate the Steps for Selecting a Drug Contact particularly in developing regionspharmaceutical material. Plastic such as Asia and Latin America, All plastic materials contain an additive The key steps in selecting a plastics boosted by rising demand forpackage which will include thermal packaging material and ensuring its sophisticated medical devices andstabilisers to enable processing. Elements suitability for the application may be improving medical care. The forecastsof the additive package may leach out summarised as follows. are part of The Future of Specialtywith time in contact with the Select a material type where there is a Plastics: Market forecasts to 2017.pharmaceutical product. The amount that minimal amount of known primary Looking at the contents, the reportmay be acceptably transferred to the chemical interaction between the covers specialty medical gradeproduct will depend on the nature of the pharmaceutical substance and material. materials such as ABS, COC, LCP, PC,additive and potential toxicity. In terms of the grade, selecting one PEEK, PEI, PET, PMMA, POM and Flexible materials often contain oils which has been tailored for use in food or PSU/PES. In terms of specificand plasticisers, some of which have a medical applications is a wise choice. It is application areas, the report focuseshigh propensity to migrate to contacting recommended that you discuss your on medical device housing, fluidsubstances. The plasticiser itself may be application with a technical representative of transfer systems, opthalmics, surgicaldeemed harmful and loss of the plasticiser the manufacturer. The manufacturer knows instruments and other medicalwill lead to the packaging becoming more the formulation of his material and should be equipment.stiff, brittle and prone to accidental well placed to advise on the grade and ifdamage. there are any potential problems. NOVEMBER/DECEMBER 2012 / MPN /47
  • 37. Packaging Design | Interactive Aesthetics More than Packaging: << Team Consulting’s design consultant David Robinson said that his inspiration for this innovative injector pen packaging came from online videos where consumers film themselves unboxing, or opening, the latest piece of technology. >> At the Pharmapack conference and exhibition in Paris in February 2013, UK- based medical device development consultancy Team Consulting will be showcasing concepts for how packaging of medical products can improve usability and make essential products like auto-injectors and inhalers more appealing to the patient. Team is seeing demand for their services go beyond the design and engineering of the device itself to the wider patient experience and has responded with innovative ideas which take packaging “outside the box”. “It has always been the case that devices have to be safe, but with new regulations around human factors over the last few years, the devices also have to be proven to be usable,” explains Team’s director of design Paul Greenhalgh. “This focus on safety and usability is opening the market up to some really encouraging innovation around how you make medical devices more usable, and how we can make them even more appealing to patients. We are all aiming for greater patient adherence and by tackling the big issues around why patients aren’t complying with their treatment we can make some improvements”. The firm says that this is now leading them and other pioneers in the medical devices space to think about all aspects of the patient’s interactions with the device, such as the instructions, the packaging, the device itself and supportive aids like mobile apps. “We are working with our pharmaceutical clients to improve their IFUs (instructions for use) and this led me onto these concepts for device packaging,” explains Team’s David Robinson,48/ MPN / NOVEMBER/DECEMBER 2012
  • 38. PHARMAPACK 2013Team Takes Drug Delivery Outside the Box “Think of them as pop-up books. As each page is turned to access the device, information is presented to users in bite size chunks, firing their ‘mirror neurons’ as they explore the device, intriguing and delighting them, and drawing them further in.” a design consultant. “I’d seen ‘unboxing’ videos online, where consumers film themselves opening that latest piece of technology, and I thought about whether we could use the same principles in our clients’ packaging.” The result, according to Team, is that it could really help patients to understand how to use their device correctly. This could help reduce anxiety in patients and, in some cases, even generate some levels of excitement. At Pharmapack, Team will be showcasing its concepts and demonstrating what is possible if the industry thinks creatively and actively challenges the status quo. Robinson explains, “Think of them as pop-up books. The auto-injector or inhaler sits behind a thermoformed plastic and can be seen through a cut-out in the instructions. As each page is turned to access the device, information is presented to users in bite size chunks, firing their ‘mirror neurons’ as they explore the device, intriguing and delighting them, and drawing them further in.” Team seems to take great delight in challenging the sector to think about their devices as more than just the packaging around the drug. As they’ve said a number of times during our discussion, the device is the interface between the drug and the patient, and the packaging and peripherals are an extension of this. “Medical devices are prescribed by doctors; patients don’t choose an inhaler or injector pen as they would a smartphone or tablet computer. There is usually a lot of anxiety and concern as patients get their heads around their treatment regime and of course the enormity of any condition that they have been diagnosed with. Anything that we can do to reduce this—even slightly—is well worth doing,” Greenhalgh concludes. NOVEMBER/DECEMBER 2012 / MPN /49
  • 39. EVENTS medical plastics | DIARY 2012/13 Ireland Medical Technology Plastics trade show 10th Indian Medical Devices & Excellence Awards January 7-10, 2013 Plastics Disposables conference December 13, 2012 Dubai, UAE January 12-13, 2013 Galway, Ireland Ahmedabad, India Medical devices and health insurance Polyolefins conference Polyolefins conference conference January 30-31, 2013 February 24-27, 2013 January 15, 2013 Amsterdam, The Netherlands Houston, Texas Berlin, Germany Medtech trade show Drug delivery and packaging Medtech trade show February 11-14, 2013 trade show February 26-28, 2013 Annaheim, California, USA February 13-14, 2013 Stuttgart, Germany Paris, FranceSPE Conference Success: Vinyltec 2012 in ReviewBy Jodie Laughlin Declared a great success by attendees and organisers alike, Sponsored by SPE andVinyltec 2012 boasts 165 conference attendees, 25 SPE Vinyl Plastics Division,presentations, a stellar slate of exhibitors and sponsors, 13 new this year’s conference wasSociety of Plastics Engineers (SPE) members as well as 3 keynote hosted by the Chicagospeakers including SPE President Jim Griffing with the Boeing Section EducationalCorporation. In addition, the one-day pre-conference seminar Foundation. Held at thehit record attendance with 78 seminar attendees. The strong very newly renovatedconference attendance again this year is consistent with numbers Marriott O’Hare Chicago,delivered the previous two years: 166 in 2010 and 151 in 2011. Vinyltec 2012 attracted engineers, technicians, With Versatile Vinyl Plastics: Formulating for the Future the researchers and managers involved in the PVC product valuefocus of this year’s conference, presenters addressed a range of chain. Looking forward, Iselin in New Jersey will host next year’sPVC topics including plasticisers, phthalates, sustainability, safety, Vinyltec on October 21-23, 2013.performance, recycling and regulatory update. In his keynote, Jodie Laughlin, aFormosa’s Plastics USA’s Brad Esckilsen delivered a Resin Market member of the SPE for 14Update while Kevin Ott of Flexible Vinyl Alliance recapped years, is vice president ofFlexible Vinyl Business Issues. SPE Chicago Section Injecting medical plastics into the conversation, Len Czuba Educational Foundation,(pictured top right) presented Flexible PVC in the Medical serves on the board ofDevice Industry—A Review of the Concerns Related to Its Use, directors of the SPEintroducing the idea that if a specific patient population is Medical Plastics Divisionadversely affected by phthalate plasticisers, it may be prudent to and is channel director,avoid exposing that segment of users to DEHP. However, Len alternative distributionsaid that 40 years of proven safety and effectiveness should with GE Healthcarecontinue to justify the use of DEHP plasticized flexible PVC in Americas.medical devices for the majority of users, the non-affectedpopulation.50/ MPN / NOVEMBER/DECEMBER 2012