Medical Plastics News November-December 2012

MPNMEDICAL PLASTICS NEWS

ISSUE 9November/December 2012

WWW.MPNMAGAZINE.COM

ALSO IN THIS ISSUE:Bioresorbable polymersPlastic electronicsDrug contact plastics at Pharmapack

M I C R O M A T T E R Pushing Moulding Boundaries with Accumold

NOVEMBER/DECEMBER 2012 / MPN /3

5. Editor’s Letter: A thousand milesAs the MPN journey moves into its thridyear, I take a look back at the steps thatbrought us to where we are today,including the most recent Compamedand Medica shows in November 2012.

6. On the Pulse: Proposed regulationThe key changes in the 194-pageEuropean medical device regulationproposal are outlined. Also, news of thedevices and diagnostics ally MedTechEurope.

11. The SPE: Supercritical CO2Supercritical gases are being used asplasticisers, to improve processing ofviscous high molecular weight polymers,and for injection moulding of foams.

14. Plastic Electronics: Smart switchA report from Engel about mouldingwipe-clean capacitive electronic switchesby overmoulding film-based printedelectronics. Also, news that resorbableelectronics are a reality.

18. Materials: Bioresorbable polymersUS patent applications referencingresorbables have grown by 37% a yearin 2005-11. Sam Anson investigates why.The article covers compounding,mechanical properties and degradationtimes, moulding and extrusion, additivemanufacturing of resorbable tissueengineering scaffolds, Absorb—the firstresorbable stent, Purac glass fibrecomposites, supercritical CO2sterilisation, and coloration.

26. Folio: Liquid siliconeA low-viscosity, addition-curing siliconefor soft compression effects.

29. Country Report: GermanyGermany is the European leader ininnovation—second only to the USA interms of patent registrations. The reportis followed by a round up of medicalplastics research institutions in Germany.

34. Cover Story: Micro matterPushing micro moulding boundaries withAccumold.

37. Design 4 Life: Licensed to CureDassault launches dedicated medicaldevice design sofware.

38. Modular Cleanrooms: A guide Sean Fryers of Connect2Cleanroomsgives us a glimpse into the versatileworld of modular cleanroms.

41. Doctor’s Note: Plastic and 3D TomoMachined plastics help physicists testperformance of 3D digital breasttomosynthesis imaging equipment.

42. Pharmapack: Drug contact plasticInterview with Steve Duckworth, head ofmedical and pharma at Clariant, aboutadditives for cyclic olefins, extractablesand leachables by Joy Harrison ofSmithers Rapra, and “out of the box”packaging design from Team Consulting.

50. Events: Diary and VinylTecMedical plastics diary in Q1 2013 and areview of SPE’s VinylTec conference inChicago by Jodie Laughlin.

MPN All Medical, All Plastics

Editor’s Letter—page 5

Pharmapack Preview—page 42-49

Plastic Electronics—page 14-16

Bioresorbable Polymers—page 18-25

Folio—page 26

Contents

Online and in digitalMedical Plastics News is available online, at www.mpnmagazine.com, andin digital (on the iPad, mobile phones and computers).

MPN | CREDITS

editor | sam anson

advertising | gareth pickering

art | sam hamlyn

production | adrian price

subscriptions | tracey nicholls

publisher | duncan wood

Medical Plastics News is available on freesubscription to readers qualifying underthe publisher’s terms of control. Those

outside the criteria may subscribe at thefollowing annual rates: UK: £80

Europe and rest of the world: £115

Medical Plastics News is published by:Plastics Multimedia Communications Ltd,

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Tattenhall, CH3 9GAT: +44(0)1829 770037 F: +44(0)1829 770047

© 2012 Plastics MultimediaCommunications Ltd

While every attempt has beenmade to ensure that the informationcontained within this publication isaccurate the publisher accepts no

liability for information published inerror, or for views expressed. All

rights for Medical Plastics News arereserved. Reproduction in whole or

in part without prior writtenpermission from the publisher is

strictly prohibited.

MPN | EDITOR’S LETTER

ISSN No: 2047 - 4741 (Print)2047 - 475X (Digital)

BPA WorldwideMembership

A journey of a thousand milesbegins with a single step. This phrase byChinese philosopher Lao Tzu, who diedin 531 BC and was a contemporary ofConfucius, sums up very nicely wherethings have come in the last 18 monthsat Medical Plastics News.

The first step on the Medical PlasticsNews magazine journey was taken twoyears ago—in November 2010—whenI flew to Düsseldorf to visit the Medicaand Compamed shows for the firsttime. The trip was booked after I hadpresented to my publisher the originalidea for a magazine dedicated tomedical applications for plastics.

I headed there with the goal ofmaking as many contacts as possible atcompanies involved in the use ofplastics for medical applications. I waspleased to find that the show was ahotbed of advanced medical plastictechnologies.

By the time I arrived at Compamedthe following year, our thousand-milejourney had well and truly begun. In thepreceeding twelve months, togetherwith my colleague Gareth Pickering, Ihad developed and published threeissues of a new medical device maga-zine concept covering the medicalplastics supply chain. The model enc-ompasses resin supply and pricing,design and materials selection, machin-ery and auxiliaries, processing methodsincluding moulding and extrusion, endof line technology, regulation as well asproduct focuses and clinician reviews.

A year on and I have just returnedfrom my third Compamed and Med-ica event in a row. Being familiar withthe layout of the halls at Messe Düss-eldorf certainly helps make the mostof the short time available at theevent. But representing what is now arecognisable brand in MPN is a bigplus when lining up interviews withimportant industry representatives.Furthermore, our pledge of editorialindependence and technical accuracyhas clearly built a firm foundation oftrust and reassurance in the industry.

Illustrating our achievements so far,Jesper Laursen of Danish compounderMelitek, said to me this month: “I sawyour article about DEHP and wanted tocommend you on the result. You pulledtogether information from a lot ofinterest groups which had the potentialto get very complicated. You reportedthe issues accurately, independentlyand carefully and this demonstratedyour professional skills. You have shownthat you are a proper journalist andMPN is a proper magazine.”

Chris James of Monaco-basedmedical plastics company Promepla alsocongratulated me. He said: “MPN fills agap in the industry for plasticmanufacturers. It is highly relevant, thecontent is well researched andinsightfully written. Sam—yourknowledge of medical is impressive.”

Lao Tzu’s philosophy is helpfulbecause it encourages people to achievethings that they would otherwise deemimpossible. By breaking things down intosmall parts, a task of a size or complexitytoo great to tangibly conceive instantlybecomes achievable. And this is a usefuloutlook on other aspects of work, as wellas life in general.

<< At Compamed 2012, FriedrichEchterdiek from moulder Spang &

Brands shone a light on cost saving forbag manufacturers, like investing in

tooling for a twin shot cap design,reducing assembly steps and

simplifying manufacturing. Imagecourtesy of PR Portfolio. >>


6/ MPN / NOVEMBER/DECEMBER 2012

INDUSTRY NEWS | Medical Device Regulation

Europe’s Proposed Medical Device Regulation

On September 26, 2012, theEuropean Commission issued a proposalto overhaul regulations for medicaldevices and active implantables. Theproposal document is 194 pages longand is a more stringent approach todevice regulation. It aims to bring about atransparent and traceable supply chainfocusing on the life cycle of a broaderrange of products.

If implemented, being a regulationrather than a directive, it will be applied “asis”, bringing consistency across EU states.

The terms of the regulation itself aresubject to change following discussion andapproval by the European Parliament.

Once the final wording of theregulation is published it will enter intoforce 20 days later and come into fulleffect three years after that. Therefore, itis likely to be at least 2017 beforemanufacturers are required to comply.

Weaknesses of the MDDThe new proposal aims to correct

weaknesses in the current Medical DeviceDirective (MDD). The biggest changeconcerns the oversight of notified bodies—which has led to inconsistency of

implementation of existing rules from onemember state to another as evidenced byrecent reports by UK newspaper TheTelegraph. It is also directed towardsaddressing the problem related to post-market surveillance, highlighted recently bythe PIP silicone implants scandal, wherebycompetent authorities do not have sufficientmechanisms to monitor information andimplement market surveillance.

DefinitionsThere are more definitions in the

proposal document than the MDD—50compared with 14. The definition of amedical device has been expanded toinclude aesthetic implantable devices (forexample cosmetic breast implants or non-corrective contact lenses) and invasivedevices used in humans with associatedexamples.

Medical Device Coordination Group The proposed regulation would involvethe establishment of an expert committeecalled the Medical Device CoordinationGroup, made up of members from EUstates and chaired by the EC. The groupwill be responsible for

WORDS | SAM ANSON

administration of the regulation and thescrutiny procedure related to high riskclass III implantable devices (see later).

Economic OperatorsWith a view to achieving better

transparency and traceability, Chapter IIsets out requirements for economicoperators—manufacturers, authorisedrepresentatives, distributors andimporters. The responsibilities of alleconomic operators are defined.

Manufacturers and authorisedrepresentatives must have an approvedqualified person appointed who is anexpert in the field with qualifications.There are also requirements placed onthe manufacturer with respect toquantity-structure-property relationships(QSPRs), technical documentation, qualitymanagement systems, post-marketsurveillance plans and clinical follow upsand labelling languages.

As far as distributors and importers areconcerned, imported devices must bearthe importer’s name on the device or itspackaging. There are requirements thatimporters must carry out sampling ofmarketed products while monitoring

October 1, 2012

EC Publishes

Proposed medical

device Regulation

October 9,

2012 North

American Sales

of Medical

Plastics to

Grow by

5.2 per cent a

Year to 2018

Former surgeon and Eucomed chairmanDr Guy Lebeau (pictured) said: “I urgeall decision makers who want to makefundamental changes to the Europeansystem for medical devices to tread withcaution. I fully agree that changes needto be made to the current regulatoryframework but let’s make sure we keepthe best system for patients and medicalprogress in Europe.”

“Abbott has remained committed to meeting the growing physician and patientdemand for a bioresorbable vascular scaffold—from the initial devicedeveloped nearly 10 years ago to the expansion of our manufacturingcapabilities to support this international launch,” said John M Capek, executivevice president, Medical Devices, Abbott.

October 8, 2012

Abbott Launches

First Ever Fully

Resorbable

Vascular Stent

October 10,

2012

Eucomed and

EDMA Launch

MedTech Europe,

a New Allied

Devices and

Diagnostics

Association

“There has also beenheightened focus onengineered polymerssuch as co-polyether-ester elastomers(COPE), polyetherblock amides (PEBA),and acetal chemistriesthat have moreadvanced performanceproperties for niche,technologicallyadvanced healthcareapplications, such astissue engineering andimplants,” said researchanalyst TridishaGoswami. “These newmaterials will expandthe scope of plasticpolymers' applicationand propel themarket.”


ON THE PULSE

The European InformationCentre on Bisphenol A, asub division of Europeanplastics industryassociation PlasticsEurope,comprises representativesfrom the mainpolycarbonate producersin Europe—BayerMaterialScience, Dow,Sabic, Styron andMomentive.

David Jones, director ofCommunications at ABHI,said: “The DailyTelegraph’s investigationinto Notified Bodies (NBs)highlights an issue thatABHI has raised withauthorities on a number ofoccasions. The control ofNBs across Europe has notbeen rigorous enough andthis must be improved.” 24

October 23, 2012

Polycarbonate

Producers Condemn

French Proposed Ban

of Bisphenol A

October 24,

2012 ABHI

Admits Notified

Bodies

Problem

Following

Telegraph

Undercover

Report

“The PVCMed Alliance will activelycommunicate about PVC and itsadditives, its properties and itsessential contribution to qualitycare delivery for healthcareprofessionals. It will also promoteinnovative and environmentallyfriendly practices in PVC healthcareapplications”, explains PVCMedAlliance spokesperson Brigitte Dero.

October 31,

2012 European

Medical PVC

Industry

Forms PVCMed

Alliance

“The [MedTech Europe]alliance not only signifies astronger and moreconsistent representation ofEurope’s medical technologyindustry, but also provideshealthcare stakeholders withone unified industrydiscussion partner whenneeded. Being able to speakwith one organisation aboutmedtech issues should makethe lives of healthcareplayers easier and makesindustry representationmore credible andimpactful,” said SergeBernasconi, chief executiveofficer of Eucomed, theEuropean DiagnosticsManufacturing Association(EDMA) and MedTechEurope.

complaints. Furthermore, these entitiesmust declare that they have complied withthe requirements of the relevant clauses inthe proposed regulation document.

Additional Device TypesNew devices to be included and

specifically defined are: devicesincorporating medicinal product anddevices composed of substances or acombination of substances intended tobe ingested, inhaled or administeredrectally or vaginally; devices incorporatingmaterials of biological origin; andsoftware in devices and standalonesoftware.

Eudamed Medical Device Databaseand Unique Device Identifiers (UDIs)

Chapter III proposes a process by whichdevices can be tracked within the EU. Itconsists of a newly established medicaldevice database—known as Eudamed—with a mandatory requirement on notifiedbodies, economic operators and memberstates to input data. A key component ofthe system is the unique device identifier(UDI), a set of data which must be compiledand submitted for every device sold in theEU market. It is proposed that class IIIdevices will be separated out and subject toa separate scrutiny procedure and, as partof the data submitted, a summary of safetyand clinical performance must be included.

Notified BodiesPerhaps the greatest proposed

change to the regulatory system surr-ounds notified bodies and theirmetamorphosis from an industry partnerinto what Emergo describes as “a police-like extension of the authorities’ marketsurveillance apparatus”.

Existing notified bodies will be subjectto annual monitoring by authorities andan assessment once every three years bya joint assessment team. There are alsonew minimum requirements for notifiedbodies, set out in annex VI.

The proposal also sets out terms forthe so-called scrutiny procedure—how anotified body should notify the MedicalDevice Coordination Group about newimplantable class III devices, including thepresentation of a Summary of Safety andClinical Performance document createdby the manufacturer. When explainingthis requirement, Emergo pointed outthat many manufacturers may not havecompleted this document at this stage.

Overall, the proposed legislation overnotified bodies is expected to be costly.

Clinical Evaluation and InvestigationAs was generally expected, the roles

of clinical evaluation and investigation aremore prominent in the proposedregulation than in the MDD. There arerequirements quoting specific ISOstandards and guidance documents and

Eudamed database registration isitemised. The process for a post-marketclinical follow-up is also explained.

Market Surveillance and SeriousIncidents

Under the proposal, manufacturers arerequired to report a serious incident within15 days. The EU database will be used toshare these reports to relevant bodies.

Industry ResponseIn general, the proposal has been

welcomed by the industry. However, therehave been concerns that the proposedscrutiny procedure for high risk class IIIdevices is too tough and could stifletechnological development and delaydevice uptake—a key competitive edge ofEurope’s medical device industry at present.

At the same time though, othercommentators have suggested that theproposal should be taken with a degreeof political context. The Eucameddatabase will require an increase in spendby the European parliament and medicaldevices may not be outside the currentclimate of austerity for many memberstates. Getting the funding for theproposal through parliament may not beas easy as many people think.

Credits: The above article was compiled usinginformation from medical device regulationconsultants Emergo Group and Meddiquest.

12:12:2012PREVIOUSLY ON MPNMAGAZINE.COM



ON THE PULSE

INDUSTRY NEWS | Devices and Diagnostics Industries Ally

Allied Medical Devices andDiagnostics Industry GroupMedTech Europe

The Purpose of a Diagnostic Test

The alliance will belegally established bythe end of 2012 andwill collaborate closelyon common policyinterest areas. AllEuropean medtechassociations are invitedto join.

Initially, MedTechEurope’s focus will bedivided into fiveparts—legislativeframeworks for medicaldevices and in vitrodiagnostic (IVD)products; the Europeanmedical technologyindustry’s five-yearstrategy; health

technology assessment; patients and safety; andenvironmental issues.

Medtech Europe has made a strong start to its role asan ally between the medical device and diagnosticsmanufacturing industries. It has published a new report onvalue-based innovation, updated an industry strategydocument and overhauled the

www.reforminghealthcare.eu website. The new report onvalue-based innovation focuses on how Europe's medicaltechnology industry is delivering on a promise of a“Contract for a Healthy Future”. The updated industrystrategy document, entitled Industry Strategy, Contractfor a Healthy Future, details the role of Europe’s medicaltechnology industry in steering healthcare systems onto asustainable path. Together with a third report by theEconomist Intelligence Unit on Future-proofing WesternEurope’s Healthcare, these reports are available as a freedownload on the reforminghealthcare.eu website.

The board of Medtech Europe will comprise threerepresentatives from EDMA and three representativesfrom Eucomed. The chairmanship will rotate between itsmembers. The board will decide future topics ofcollaboration.

Announced as a European Industry Alliance in January2012, MedTech Europe will work alongside its foundingmembers and will remain a separate entity, as will EDMAand Eucomed. Medtech Europe is not an umbrellaassociation on top of Eucomed and EDMA.

The three associations will be helmed by one chiefexecutive officer—Serge Bernasconi. Mr Bernasconisucceeded the previous chief executive of Eucomed,Luciano Cattani, and director general of EDMA VolkerOeding on July 16, 2012.

In vitro diagnostic (IVD) tests are being created forhome use, empowering patients with information abouttheir health and giving doctors the tools to optimisetreatments.

Diagnosis is the process of finding out if a patient hasa specific disease. A medical professional prescribes a testto make a diagnosis or to exclude possible illness. Theresults are used to implement treatment or carry outfurther tests.

Monitoring intends to see if the disease is controlled,a purpose that is very common in chronic diseases such asdiabetes. Symptoms can be managed with medication,hormones or lifestyle changes.

Screening consists of studying patients who do not yetpresent any signs or symptoms of a specific illness in orderto find out if it has begun to quietly develop and if so, tobe able to apply treatment as soon as possible. These testsare applied to large segments of the population andshould therefore be simple and cheap.

Prognosis allows clinicians to assess the likelihood apatient has for developing a disease in the future andtherefore take precautions earlier rather than later. Genetictests, for example, analyse a patient’s predisposition fordeveloping a disease, allowing the patient and doctor tobe more attentive to discovering early signs of the diseaseand to take preventive measures as needed.

On October 10, 2012, theassociations representing

the European manufacturingindustries for medical

devices, Eucomed, anddiagnostic devices, the

European DiagnosticsManufacturers Association

(EDMA), announced thatthey had formed MedTech

Europe, a new allianceintended to encourage

collaboration between thetwo industries. The

announcement was made atthe European MedTech

Forum in Brussels, Belgium.

WORDS | SAM ANSON

by Lluís Bohígas Santasusagna, director, institutional relations, Roche Diagnostics

<< Serge Bernasconi is thechief executive officer ofthe newly formed allied

Medtech Europe as well asEucomed and the EuropeanDiagnostics Manufacturers

Association (EMDA). >>

Reproduced with kindpermission of Eucomed.



ON THE PULSE

Continued on page 13

Supercritical CO2 inMedical Plastic Processing

The use of supercritical CO2 as a solvent in theprocessing of various biodegradable and biocompatiblepolymers for pharmaceutical and medical applications inthe forms of particles and microcellular foam hasgarnered much attention in the last decade. Asupercritical fluid is defined as a substance for which bothpressure and temperature are above the critical values.These fluids possess physicochemical properties—properties which are both physical and chemical—such asdensity, viscosity and diffusivity. Density, viscosity anddiffusivity are intermediate between those of liquids andgases and are continuously adjustable from gas to liquidwith small pressure and temperature variations. Both thecapability of supercritical fluids to replace toxic solventsand the ability of tuning solvent characteristics for highlyspecific separations or reactions have led to the currentscientific and industrial interest in supercritical fluids. Asupercritical fluid has the unique ability to diffuse throughsolids like a gas, and dissolve materials like a liquid. CO2 isa promising alternative to noxious organic solvents andchlorofluorocarbons. It has shown versatility as asupercritical fluid in the synthesis as well as processing ofpolymers owing to its attractive physical properties. It isnon-toxic, non-flammable, chemically inert andinexpensive. Its supercritical conditions are easily attained(Tc = 304.15 K, Pc = 7.38MPa) and it can be removedfrom a system by simple depressurisation.

A Processing Aid for Viscous High Molecular WeightPolymers

The processing of polymers is highly influenced by theviscosity of the bulk materials. Raising the processingtemperature or the addition of volatile or harmfulplasticisers are often seen as solutions in overcoming theinherent difficulties encountered when processing highmolecular weight polymers. However, higher temperaturesduring processing can lead to thermal degradation. Also,added plasticisers remain in the product and thus alter itsproperties and performance. The low thermal stability ofhigh molecular weight biodegradable polymers has led tothe emergence of supercritical CO2 as a useful processingaid. There are many examples of the use of pressurisedgases to lower the melt viscosity of numerous amorphousand semicrystalline polymers. Polyethylene glycol,polystyrene and polydimethylsiloxane are examples ofpolymers where a viscosity reduction has beendemonstrated upon the incorporation of supercritical

CO2. Biomaterials as well as polyethylene and polystyreneblends have exhibited similar behaviour.

PlasticisationThe use of supercritical fluids in the processing of

polymer melts can also lead to changes in the mechanicalproperties of the materials. Most mechanical propertychanges during processing can be attributed to theplasticisation of the polymer by the supercritical fluid andthe resultant drop in Tg. Some blended polymer materialshave shown significant increases in modulus and strengthwhen formed in a supercritical fluid assisted process, this isoften due to the tuning of the morphology and degree ofcrystallisation of the material by the supercritical fluid.Changes in the elastic and creep modulii of materials whenprocessed with supercritical fluids can occur in a range ofmaterials. However these changes and their magnitude aredependent on the solubility of the polymer(s) in thesupercritical media and the supercritical material’s ability toinduce crystallisation in the system in question.

Supercritical Fluids in Fibre CompositesPolymer composites processing can also utilise

supercritical fluid technology and extensive research hastaken place in this area recently due to the burgeoning useof these materials in the electronic and medical industries.Companies such as Ireland’s SCF Processing have beenpioneering research into bespoke industrial polymerprocessing solutions working with manufacturers toprovide tailored materials processing transfer services.Supercritical fluid can be used to carry the monomer ontothe fibres or particles to be used in the composite and toact as a plasticiser for the synthesised polymer matrix whenthe composite is formed by in situ polymerisation of themonomer. Polymer composites can also be prepared byblending the polymer and the other component in thepresence of supercritical media.

Microcellular Foam ProductsThe moulding of microcellular foam products, like many

supercritical CO2 processes, entails the formation of a singlephase solution. On venting the CO2 by depressurisation,thermodynamic instability causes supersaturation of the CO2dissolved in the polymer matrix and hence nucleation ofcells occurs. The growth of the cells continues until asignificant amount of CO2 escapes, the polymer passes

BY DR SEAN LYONS,SENIOR SCIENTIST ATBAUSCH + LOMB, IRELAND

Industry News from the SPE | Supercritical Fluids in Medical Plastics


50%, reduced scrap rates, and lowerenergy consumption (energy savingsare based on reduced processingtemperatures and are processdependent); lower capital coststhrough the purchase of smaller andfewer machines, and fewer and lessexpensive moulds; reduced materialcosts through component densityreduction, thinner design, and materialsubstitution; and the ability to mouldthermoplastic parts that have asubstantially higher dimensional stabilitywhich are free of warpage.

The use of supercritical fluids in themedical device sector affords theopportunity to add a new and excitingdimension to the processing ofpolymeric materials. Examples ofmedical devices currently beingproduced commercially using thistechnology include endoscopes, heartpumps, inhalers and nebulisers. The useof supercritical CO2 as an inexpensivesolvent in many polymer processingapplications has already brought manybenefits to the industrial sector. Asusage becomes more widespread,materials that had previously beendesignated as ‘un-processable’ due totheir high viscosity or their thermalinstability can now be reinvestigatedwith the aid of supercritical fluids.Supercritical fluid technology has notyet reached its potential within industry.However, considerable research intothis field is ongoing which wouldindicate that the number of applicationsand the usage of this technology areonly likely to grow. Supercritical CO2 isalso examined as a sterilant ofbioresorbable devices on pages 22-25.

Medical Plastics News would liketo thank Austin Coffey of the Societyof Plastics Engineers EuropeanMedical Polymers Division for his helpwith this article.

through its Tg and the foamed structureis frozen in place. An added advantageof this technology is that due to thelower pressures and softer fills, delicateitems can be overmoulded withoutmuch of the traditional displacementand resultant need for excessive controlfeatures. USA-based Trexel’s MuCellprocess technology is said to have beenthe first to widely offer microcellularfoaming for both extrusion and injectionmoulding processes and as a result itstechnology is often licensed toindustrial partners. Optifoam licensedby Switzerland’s Sulzer Chemtech is anexample whereby the supercritical fluiddosing element is the nozzle of themachine as opposed to the barrel.

Another example is Ergocell, theinjection moulding process operatedby Japan’s Sumitomo (SHI) Demag forthe production of microcellular foamedproducts. The cycle sequences in theErgocell process essentially correspondto the sequences in the standardinjection moulding process. Thedecisive difference is in the gasdelivery, which takes placesimultaneously to plasticising. As thescrew draws in, melts and deliversmaterial into the space in front of thescrew and—in the process—is beingpushed back against the back pressure,gas is fed into the melt from a gasmetering station. Thus, the screw movesback at a speed that is a function of theplasticising capacity of the screw.Simultaneously, an amount of gas aspreset by the operator is deliveredinto the melt. In contrast to the MuCelltechnology, which requires a modifiedscrew assembly, the injection of thesupercritical fluid into a moduledownstream of a conventionalplasticisation unit in the Ergocelltechnology means that it can be easilyremoved, allowing the injectionmoulding equipment to be used in aconventional process when required.

Advantages of Supercritical GasAssisted Injection Moulding

The primary advantages ofsupercritical gas assisted injectionmoulding are: reduced operating coststhrough cycle time reductions of up to

A new European association,the PVCMed Alliance, has beenlaunched to promote the use andvalue of PVC in healthcareapplications. PVCMed is analliance of the PVC medicalindustry chain represented byPVC resin and plasticiserproducers and PVC converters.The alliance’s aim is to provide afocal point for communication withhealthcare professionals andregulators about PVC-basedhealthcare applications, and theirfundamental role in quality ofhealthcare, safety and cost-efficiency, all whilst beingenvironmentally responsible.Through an interactive platform,the alliance seeks to consolidate astrong dialogue with all involvedstakeholders to continueimproving healthcare deliverytogether.

“The PVCMed Alliance willactively communicate about PVCand its additives, its properties andits essential contribution to qualitycare delivery for healthcareprofessionals. It will also promoteinnovative and environmentallyfriendly practices in PVChealthcare applications”, explainsPVCMed Alliance spokespersonBrigitte Dero. Ms Dero adds: “Thequality and safety of PVC-basedhealthcare applications guaranteeefficient and widely affordablehealthcare systems to continuouslyimprove and save patients’ lives.”

At the time of going to press,members of the PVCMed Allianceinclude BASF, Colorite Europe,Eastman, the European Council ofVinyl Manufacturers (ECVM),OXEA, Renolit and Tarkett.

Continued from page 11

Organisations Collaborateon PVC in Healthcare

ON THE PULSE

At the Touch of a Button: Wipe-Clean Moulded Switches for Medical Engineering

Some people have earmarked smart plastics as aconverging technology where capacitive electronics havebeen combined with injection moulding. Others havedescribed them as a new type of composite technology.Fundamentally, they consist of a plastic part mouldedover a film which has had electronic components printedonto it (see image below left). The result is an aestheticallypleasing part with smooth lines and a clean shiny finish.The part has electronically interactive parts built in to it toform switches and buttons.

The electronics components consist of capacitivesensors which utilise the principle of electrical capacity—the reciprocation between two spatial points (as in theelectric force field between two electrodes). The electricflux lines within an electric field may be changed byintroducing a conductive object (such as a fingertip). Thecapacitive sensors pick up these changes and respondwith a voltage variation that can be used to initiate aparticular function—such as an on/off or up/downcommand. Since the field lines penetrate non-conductivesolid bodies, the sensor effect also works from a distancethrough a thin surface layer such as a thermoplastic or anoperator's gloves.

For electronic medical devices, controlcomponents such as switches and buttons

must not only be easy to operate—theymust also be easy to clean. They are

notorious for attracting germs and dirtparticles, particularly in and around the

tiny crevices and gaps between thevarious components and connections. Thedevelopment of smart plastics—moulded

components with capacitive electronicfunctionality—offers device

manufacturers the opportunity todevelop wipe-clean electronic buttons

and switches while improving productionefficiency and achieving better and more

complex designs.

<< Above: Smart plastics representnew opportunities for the medical

engineering sector, especially in thedesign of operator control units. >>

<< Below: Sensors and conducting pathsare printed onto the film; themalleability of the film gives productdesigners ample scope. >>

Electronics in Plastic Devices | Smart Plastics



PLASTICELECTRONICS

The films can be configured in three dimensions andcut before being overmoulded or back-injected withthermoplastic. In this way, capacitive electronics canreplace mechanical switches, buttons and control knobs.The operating elements are covered by a continuous,even and highly resistant interface.

Smart Plastics in CarsAccording to Austrian injection moulding machine

manufacturer Engel, smart plastics have undergone mostdevelopment in the automotive sector. Michael Fischer(pictured right overleaf), sales manager (technologies)believes: “The cars of the future will be easier to operatethan smartphones, simply by touch, feel and interaction.”

At its open house in June 2012, Engel presented itsfirst close-to-production application for smart plastics (seeimage). Centre consoles for cars with a sensitive interfacewere manufactured using an Engel duo 350 injectionmoulding machine with reversing plate and combinationmould. A capacitive, three-dimensional pre-formed filmwas placed into the mould by a robot and overmouldedwith PC/ABS. The component was then flow-coated withpolyurethane to protect the surface and produce a highquality impression.

The technology will now be marketed under the nameSensitive Surface by Engel and its project partners. “Weare in discussion with various automobile companies andOEMs with a view to mass-producing the first sensitivesurface applications in three to four years”, reveals Fischer.

In the case of vehicle construction, the hygieneaspects of a continuously sealed interface are lessimportant than ease of use and high efficiency in themanufacturing process. Whereas conventionalmanufacturing often involves the individual productionand assembly of more than 100 small parts, capacitivefilms and plastic granulate facilitate the production offunctional, ready-to-install components in a single workstep. “Taking the centre consoles as an example,production costs are reduced by at least 30% if we lookat the whole process”, emphasises Michael Fischer. Since

no assembly is required, productivity is also increasedsharply.

Pushing the Boundaries of Product DesignAmple scope for design through injection moulding is

a real benefit here. The flexible print production for thefilms makes it possible to position sensors almostanywhere; films can also be formed into virtually anyshape. Sensitive surface technology is therefore the idealmeans by which to develop operator control units costeffectively—units that Engel say are unbeatable in termsof usability and ergonomics.

Of course, ergonomics and cost-effectiveness havebeen key considerations in other sectors of industry formany years. With this in mind, a design study for thecontrol panel of a washing machine was recentlypresented. Meanwhile, Engel and its partners are startingto field enquiries from the medical engineering sector.

“I think the fact that this technology addresses a wholeset of requirements at a stroke represents a majoropportunity for medical engineering”, says ChristophLhota (pictured middle overleaf), the head of Engel'smedical business unit. “Firstly we're doing more toaddress stringent hygiene requirements, secondly we'reimproving the ergonomics of medical engineeringproducts and thirdly we're drastically cutting productioncosts. Pressure on costs is rising in the medicalengineering sector too.”

At present, lessons learned from the automobileindustry are being developed and applied to the medicalengineering field. Alongside Engel, a company heavilyinvolved in the specialist development and production ofintelligent, multi-layered interfaces is Austria-headquartered smart plastics technology developerplastic electronic. One key development issue at present isthe sterilisability of intelligent electronic components. “Wesuccessfully carried out function tests for the automobileindustry in the temperature range of -40°C to +85°C”,reports Philipp Weissel (pictured left overleaf), CEO of

<< The manufacturing cell for centre consoles with capacitiveelectronics delivers outstanding cost effectiveness. A highlevel of automation—and the sensitive surface technology

itself—are critical factors. >>


<< Injection moulding covers the electronic elements witha continuous and highly resistant plastic interface. >>


Electronics in Plastic Devices | Smart Plastics


plastic electronic. “We're now working on raising thetemperature range for critical applications in medicalengineering.”

Upper Austria Hailed as Epicentre of Smart PlasticsEvolution

As far as the future research activity of Engel andplastic electronic is concerned, Upper Austria promisesideal conditions. Few places elsewhere in the world aresuch a high concentration of companies and researchinstitutes to be found alongside the infrastructure neededfor smart plastics. Early in 2011, this density of specialistexpertise led to the foundation of a smart plasticsnetworking group, the Smart Plastics initiative. The aim ofthis group is to accommodate the entire value chain forintelligent electronic plastic products within UpperAustria so that world-leading system solutions may bedeveloped in partnership. To further this goal, SmartPlastics is hosting a congress in Linz, Upper Austria—thesame place where Engel’s headquarters are—on June 10-11, 2013.

Editor’s OutlookPlastic electronics may help designers find an

alternative to conventional membrane keyboards inmedical situations. These membranes attempt to integratea continuous seal over an interface, but are said to be lessthan robust in practice and constitute a source ofinfection in sterile environments like operating theatres.Thanks to the commitment in Austria for smart plasticsand Engel’s lead in the moulding expertise, observers canexpect product designers to turn to smart plastics forimproved functionality, aesthetic design, not to mentionthe wow factor of a highly sensitive button which requiresabsolutely no pressure to activate. It takes the phrase “atthe touch of a button” to a whole new level.

It’s not often that a doctor can claim two game-changing inventions in less than a year. That’s what DrMarvin J Slepian can boast, having developed a new classof small, high performance electronics that arebiodragradable and capable of dissolving completely inwater or bodily fluids following a predefined period offunctionality. Earlier this year, Dr Slepian’s company,Syncardia—a US-based medical device manufacturer—developed and successfully implanted the first artificialplastic heart. In the 1980s, Dr Slepian developed one ofthe first prototypes for biodegradable stents.

Dr Slepian is director of interventional cardiology andprofessor of medicine at the USA’s University of Arizona(UA) Sarver Heart Center with a joint appointment in theUA department of biomedical engineering. He is also co-founder and chief technical officer of Syncardia.

Details of the technology on which this dissolvableelectronic device is based—known as transientelectronics—were published in a September 2012 copy ofScience, a leading US scientific journal.

The paper describes a number of examples of transientelectronic devices, including a system designed to monitorand prevent bacterial infection at surgical incisions whichhas been successfully demonstrated in rats. The paper waswritten by Fiorenzo Omenetto, professor of biomedicalengineering at the Tufts School of Engineering inMassachusetts. Omnetto worked with researchers atUniversity of Arizona and Northwestern University inIllinois. Materials found in conventional integrated circuitsare used—silicon and magnesium—but in an ultrathin formthat is then encapsulated in silk protein, which isdissolvable. Device dissolution isreportedly furthercontrolled by sheets ofsilk protein in which theelectronics are supportedand encapsulated.Omenetto and his teamhave discovered how toadjust the properties ofsilk so that a wide rangeof degradation times canbe predetermined.

Photo Source:Beckman Institute, University ofIllinois and Tufts University.

<< Left to right: Michael Fischer, Engel salesmanager (technologies), Christoph Lhota,

Engel’s head of medical, and Philipp Weissel,CEO of plastic electronic. >>

PLASTICELECTRONICS

Bioresorbable ElectronicDevices a Reality


Bioresorbable Polymers: Patents Growing by 37% a year

Material Diagnosis | Growing Popularity of Bioresorbable Polymers

WORDS | SAM ANSON

Bioresorbable polymers, also referred to asbioresorbable or degradable polymers, are polymermaterials which can be safely absorbed by the body sothat the materials from which a construction is madedisappear over time.

The following report examines bioresorbables fromthe following perpectives—compounding, mechanicalproperties and degradation times; moulding andextrusion; degradation testing; additive manufacturing ofresorbable tissue engineering scaffolds; Absorb—the firstever resorbable stent; Purac glass fibre composites;supercritical CO2 sterilisation; and coloration.

Polymer TypesThe most common bioresorbable polymer is polylacticacid (PLA), also known as polylactide, and is made from alactide monomer. Generally speaking, PLA is the mainbuilding block for bioresorbable polymer materials.Common derivatives of PLA are poly-L-lactide (PLLA),poly-D-lactide (PDLA) and poly-DL-lactide (PDLLA).When in the body, PLA degrades into lactic acid, a non-toxic chemical which occurs naturally in the body.

Polyglycolic acid (PGA), or polyglycolide (PG), isanother type of bioresorbable polymer usually used forbioresorbable sutures. The material can becopolymerised with lactic acid to form to form poly(lactic-co-glycolic acid), or PLGA, with e-caprolactone to formpoly(glycolide-co-caprolactone), or PGCL, and with

trimethylene carbonate to form poly(glycolide-co-trimethylene carbonate), or (PGA-co-TMC). PGAdegrades to form glycolic acid.

Compounding, Mechanical Properties andDegradation Times

The mechanical properties and degradation time of abioresorbable device can be tailored to a specificapplication by adjusting the molecular weight, crystallinityand hydrophilicity of the polymer. This is achieved byvarying the percentage of polylactide D or L forms, andpolyglycolide. Tony Listro, managing director of specialistUS medical polymer compounder Foster Delivery Scienceexplains: “Compositions with higher hydrophilic andamorphous structures and a lower molecular weightresorb faster, yet often sacrifice mechanical strength.Conversely, higher crystallinity and molecular weightimprove mechanical properties and decrease resorptionrates.”

Bone growth additives, such as tricalcium phosphate(TCP) or hydroxyapetite acid (HA) can be melt blendedinto these polymers to enhance bone growth duringdegradation. Additionally, the low melt temperatures ofmany bioresorbable polymers allows for melt blendingactive pharmaceutical ingredients (APIs) for controlled-release drug delivery during degradation. However,higher molecular weight polymers often require highermelt temperatures and thus limit melt blending of someAPIs with low degradation temperatures.

Twin screw extruders optimise bioresorbable polymerblending, including distribution and dispersion of additives.Due to the high cost of bioresorbable polymers, which canoften exceed US$1,000 per lb (US$2,200 per kg) and therelatively small nature of the implantable applications, smallscale twin screw extruders—between 16 mm and 27 mm—are ideal. Since these polymers begin degradation whenexposed to moisture, desiccant and vacuum driers arerequired prior to melt blending. Unlike non-resorbablepolymers that are often water cooled upon exiting theextruder in strand form, bioresorbable compounds mustbe air cooled. Pelletised strands destined for finisheddevice processing must be thoroughly dried and properlypackaged to prevent exposure to air moisture that cancause premature degradation.

Bioresorbable polymers are nothing new. Theyhave been used in dissolvable sutures for a

number of years. But according to the UnitedStates Patent and Trademark Office database,

the number of patents referencingbioresorbable and medical grew from 48 in

2005 to 311 in 2011, an average annual growthrate of 37%, or 548% in absolute terms. In the

last two months, the first fully resorbable drugeluting stent was CE marked for sale in Europe.

Here Sam Anson looks at bioresorbableprocessing considerations while reviewing

examples of application success.

Additive Manufacturing of Resorbable TissueEngineering Scaffolds

Additive manufacturing is being used to producescaffolds for tissue engineering from bioresorbablepolymers. A number of years back, researchers from AStar, a leading Singaporean research institution,successfully developed a technology for fabricatingresorbable polymeric tissue scaffolds with high strengthand porosity using additive manufacturing. Dr MargamChandrasekaran (Chandra), now CEO and chief scientistat Singapore-based tissue engineering scaffoldmanufacturer Bioscaffold International, was one of thelead inventors of the technology. Along with a team ofclinicians at the National University of Singapore, at A StarChandra developed an application of the technology toproduce a commerical product for high strengthresorbable dental scaffolds usingadditive manufacturing.

Chandra explains: “Weused a combination of PLGAwith PVA and changed thebinder used in the 3Dprinting process toproduce parts in adesired shape andthen used a postprocessing techniquesimilar to particulateleaching to strengthen thestructure. In fact, besidesPLGA, we did work onPCL, PLA and PGA. Apaper was published in2007 in the Journal ofMaterials Processing andTechnology.”

Today, Chandra’scompany manufactures implantable tissue engineeringscaffolds for dentists made from PLGA. The scaffolds areused by dentists to preserve tooth sockets followingremoval of a tooth. The implant encourages bone growth,thereby preserving the socket while the gums heal. Thismeans that any further restorative procedures, such asdentures or implantable false tooth fittings, are vastlyimproved.

Another resorbable scaffold application,manufactured in the USA by tissue engineering devicepioneer 3D Biotek, is a three dimensional PLGA-baseddegradable porous cell culture device for medicalresearch processes. The device is special because itsthree dimensional nature allows cells to grow in threedimensions. Its 100% porous nature allows cells to beseeded very easily. Because PLGA is biocompatible, thescaffolds, with or without cells, can be implanted intoanimals. Degradation time is approximately 4-5 months.

Germany-headquartered 3D printer supplier

BIORESORBABLEPOLYMERS

Moulding and Extrusion ConsiderationsThe processing of bioresorbable polymers must be

handled with care. The materials themselves are highlyhydrophilic, which is to say that they love water and willabsorb any moisture with which they come into contact.Unless properly dry, the materials will not melt andrecrystallise as expected, making moulding and extrusiondifficult. At the same time, bioresorbable polymers aresensitive to heat, and molecular structures can be damagedthrough exposure to excessive temperatures during drying.

With this in mind, careful and thorough drying at lowtemperatures is needed, while the humidity of theprocessing environment must be considered.

Knowing the melt and recrystallisation behaviour ofbioresorbable materials is important, as is understandingthe melt flow viscosity. Often materials will have a lowmelt temperature, a high crystallisation temperature andgenerally be extremely viscous—like hot honey—exceptat a small temperature range between the two. Thismeans that there is a very small temperature range atwhich materials can be processed—that is to say, therange at which the material is molten, at which theviscosity is at the right level for injection moulding orextrusion, and at which the material won’t crystalliseprematurely.

Due to their delicate molecular structures,bioresorbable polymers are limited in terms of the amountof time they can remain molten, so cycle times must bekept within this range, which is often not very long.

Degradation Testing of Bioresorbable MedicalDevices

On November 28, 2012, the FDA held a publicworkshop on the testing of bioresorbable medicaldevices at its White Oak campus in Silver Spring,Maryland, USA.

The workshop, entitled Workshop on AbsorbableMedical Devices: Lessons Learned From Correlations ofBench Testing and Clinical Performance, was co-sponsored by ASTM (American Society for Testing andMaterials) International, a US organisation responsible forthe development and delivery of international voluntaryconsensus standards for engineered products, includingmedical devices.

The purpose of the workshop was to provide a forumfor highlighting and discussing the use of bioresorbablematerials in medical devices across a broad range ofindications with the aim of defining successful andunsuccessful methods to predict clinical performance.

The main topics discussed included identification oftest methods for establishing correlations between invitro and in vivo degradation of absorbable implantabledevices, and the interaction of mechanical loading andmechanical performance with degradation. While therewas an emphasis on cardiovascular indications as part of apanel session, characterisation techniques andexperiences from both cardiovascular as well as non-cardiovascular devices were discussed and encouraged.



<< The 3D–Bioplotter fromEnvisionTec is specially designed

to process a large range ofmaterials, from hard polymers,through ceramic pastes to soft

hydrogels including cells. >>



the degradation rate govern this performance.The potential long term benefits of a scaffold that

dissolves are significant. The vessel may expand andcontract as needed to increase the flow of blood to theheart in response to normal activities such as exercising.Treatment and diagnostic options are broadened. Theneed for long-term treatment with anti-clottingmedications may be reduced. And future interventionswould be unobstructed by a permanent implant.

“This innovation represents a true paradigm shift inhow we treat coronary artery disease,” said Patrick WSerruys, a medical doctor and professor of interventionalcardiology at the Thoraxcentre, Erasmus UniversityHospital, Rotterdam, the Netherlands. He added: “Withthe launch of Absorb, a scaffold that disappears afterdoing its job is no longer a dream, but a reality.”

Absorb is now available in a broad size matrix tosupport the needs of physicians treating patients withCAD. There are 7 sizes available—varying in length from12 mm to 28 mm and in diameter from 2.5 mm to 3.5 mm. The strut thickness and width are approximately150 μm and 180 μm respectively.

At the time of going to press, Absorb is neitherapproved nor authorised for sale and currently is indevelopment with no regulatory status in the United States.

Bioresorbable Glass Fibre Composites for LoadBearing

In August 2012, Netherlands-based bioresorbablepolymer manufacturer and owner of the Purasorb brandof medical resorbable polymers Purac acquired FiberLive,an advanced resorbable glass fibre composite technology.The acquisition included the intellectual property of theFiberLive technology and its key personnel.

According to Purac, FiberLive is a unique patentedcomposite consisting of a matrix of resorbable silica-based glass fibres and resorbable polymers, forming anexceptionally strong resorbable composite material—upto six times stronger than cortical bone. This uniquecomposite material widens possibilities to use resorbable

EnvisionTec’s 3D-Bioplotter is an all-purpose directmanufacturing tissue engineering machine for theproduction of hard and soft scaffolds from biomaterials,cells as well as synthetic materials. It is specially designedto process a large range of materials, from hard polymers,through ceramic pastes to soft hydrogels.

According to EnvisionTec, the 3D-Bioplotter isspecially designed for work in sterile environments in alaminar flow box, a requirement of biofabrication, forexample when using alginate cell suspensions for theconstruction of cell-laden scaffolds. Additionally, the 3D-Bioplotter can use up to five different tools per job. Thismeans that scaffolds fabricated using the 3D-Bioplottercan have up to five different materials, or five differenttypes of cells in specific positions.

In contrast to other rapid prototyping techniques the3D-Bioplotter, EnvisionTec says, uses a very simple andstraightforward technology, invented in 1999 at theFreiburg Materials Research Centre in Germany. Themanufacturing process works by air pressure beingapplied to a liquid and liquefied material, which solidifiesupon dispensing.

The 3D-Bioplotter is delivered together with a PCworkstation which operates and monitors the system. Aftertransferring the 3D CAD data to the PC it is processed bythe Bioplotter’s software package. The preprocessed datais then transferred to the 3D-Bioplotter using a networkconnection. The Bioplotter software monitors the workingprocess until it is completed.

Abbot Launches First Ever Bioresorbable VascularScaffold

USA-headquartered Abbott, one of the world'sleading medical device OEMs with 91,000 employees, haslaunched Absorb, the first fully resorbable drug elutingvascular scaffold.

Absorb is available for use by clinicians in treatingcoronary artery disease (CAD) across Europe, Asia Pacificand Latin America. It works by restoring blood flow to theheart—similar to a metallic stent—but instead of beingpermanent it dissolves into the body. After dissolution itleaves behind a treated vessel that may resume morenatural function and movement because it is free of apermanent metallic stent.

In order to create the backbone of the device, PLLAresin is extruded into a tube, then radially and axiallyexpanded in a process that resembles stretch blowmoulding. The scaffold pattern is then cut with a laser, andthe finished product is coated with a drug and polymermixture and crimped onto a catheter before beingpackaged and sterilised.

According to Abbott, PLLA has an intrinsic degradationrate that is influenced in vivo by very few factors. Deviceperformance over its degradation lifecycle is tuned tomatch physiological requirements for vessel support. Thepolylactide molecular weight in the finished product and


<< The backbone ofAbsorb, the firstfully resorsable drugeluting stent, isproduced byextruding PLLA intoa tube and thenradially and axiallyexpanding that tubein a process which issimilar to stretchblow moulding. Thetube is then laseredto produce thescaffold pattern. >>



materials into the fields of bone fixation, where in the pastit has been impossible due to a lack of load-bearingproperties of conventional biopolymers. The material canbe used in different kinds of orthopaedic treatments,including craniomaxillofacial (skull and jaw), sportsmedicine, trauma and spinal procedures.

When commenting on the acquisition, MennoLammers, managing director Purac Biomaterials, said: “Thistechnology will be a game changer in the orthopaedicresorbable market, where load bearing properties areneeded. The FiberLive technology is the strongest fullyresorbable material available for human implants, withstrength up to six times higher than cortical bone,comparable to metal. For decades Purac Biomaterial hasbeen the leading company in the field of medicalresorbable polymer materials having strong commitmentand enthusiasm towards innovation and development inthe field. With the acquisition of this innovativeresorbable composite material we are able to furtherwiden our capabilities to serve our customers accordingto their requirements.”

The Purasorb brand of resorbable polymers covers abroad range of grades, including polymers—poly-L-lactide (PLLA), poly-D-lactide (PDLA), poly-DL-lactide

(PDLLA), polyglycolide (PG), polycaprolactone (PCL)—and copolymers L-lactide/DL-lactide (PLDL),L-lactide/D-lactide (PLD), L-lactide/glycolide (PLG), L-lactide/captrolactone (PLC) and DL-lactide/glycolide(PDLG). The company also offers custom synthesis ofbioresorbable polymers.

Supercritical CO2 Sterilisation of BioabsorbablePolymer Devices

A team of researchers at NovaSterilis, a supplier ofsupercritical carbon dioxide (scCO2) sterilisationtechnologies and equipment based in the state of NewYork, working with Dr Chih-Chang Chu, a professor fromCornell University (Ithaca, NY), have developed a novelprocess for sterilising devices made from bioresorbablepolymers using scCO2. The technology is being distributedin Europe by European Medical Contract Manufacturer



<< Implantableresorbable screwsmade from PuracFiberLive. >>

Material Diagnosis | Growing Popularity of Bioresorbable Polymers


(EMCM) based in Nijmegen, The Netherlands.According to a poster presentation from the team

displayed at the Ninth World Biomaterials Congress inChina in June 2012, which reported the feasibility ofNovaSterilis’s scCO2 sterilisation method for anabsorbable suture, scCO2 is preferable to ethylene oxidewhen sterilising bioresorbable devices for a number ofreasons, as follows.

Devices can be processed at low pressure andtemperature, which reduces costs and energy requirements.Low temperature processing makes it ideal for specialistbioresorbable devices due to their highly sensitivemolecular structure (as explained earlier). Furthermore, theCO2 molecule has a low surface tension which also reducesthe likelihood of damaging delicate molecular structurescommonly found in bioresorbable materials.

The fact that scCO2 sterilisation can be used tosterilise in between the pores of a material—it is said topenetrate deeply into a substance—plays perfectly intothe hands of bioresorbable polymer devices as by theirvery nature they are very porous. The poster points tothe fact that spores can live in the pores of the materialand the method can get right between the microscopicholes to ensure they are completely sterile. Furthermore,reinforcing the delicate nature of the method, the scCO2can penetrate inside the spore and oxidise it to render it

inactive, which means that when the spore is killed, thereis little or no effect on the delicate surrounding material.

Sterilisation can be done inhouse as there are lowcapital expenditures required, meaning that devicemanufacturers can retain full control and sight of theirproducts during sterilisation. Furthermore, the time takenfor this method is much shorter than traditional ethyleneoxide—according to NovaSterilis president and CEODavid C Burns, “you are talking minutes to hours ratherthan hours to days”.

Residual chemicals are non existent or negligiblefollowing sterilisation. Any that do remain are non-toxic asconfirmed by toxicity testing.

ScCO2 sterilisation is a new technology. The first 510ksubmission is expected within the next 12 months. Fourcompanies are currently using the technology to steriliseallograft tissue because of its gentle effect on collagen(biopolymer)—three in the USA and one in Australia.

According to David C Burns, president and CEONovaSterilis: “Today’s highly technical products requirevery specialised handling, including sterilisation in smallerbatches. Moreover, the desire to maintain custody ofproduct is more important to many of our customers.”

The NovaSterilis scCO2 process is said to be safe formany polymers, allograft tissues, plastics, and surgical






metals. NovaSterilis manufactures 20-litre and 80-litre fullyautomated, computerised, and network capablesterilisation units. Designed with a small footprint, theseunits are ideal for biomedical material companies thatrequire high value and flexibility. NovaSterilis providessupportive technical services, assisting customers todetermine if this process is appropriate for specificproducts, establishing cycle times and developingvalidation and regulatory plans.

In 2007 NovaSterilis won the Presidential GreenChemistry Challenge Award Presented by the USEnvironmental Protection Agency.

Profile of a Bioresorbable Expert: DegradableSolutions, Switzerland

Degradable Solutions (DS), based in Switzerland,manufactures a number of bioresorbable products. Thecompany is a spin-off from the Swiss Federal Institute ofTechnology Zurich (Eidgenössische TechnischeHochschule Zürich—ETH) and was taken over inNovember 2011 by Swiss oral care device manufacturerSunstar Group. It is a technological leader in its field andhas extensive experience of working with bioresorbablepolymers. Two areas of interest are bone graftsubstitutes and tissue fixation devices.

Bone graft substitutes are sold under the brand nameeasy-graft and are the company’s most importantproduct. Easy-graft consists of resorbable granules ofcalcium phosphate which have been coated withpolylactic acid. The granules are injected into parts of thebody where bone needs to grow, particularly brokenbones and teeth. An activator liquid is added to thegranules just before injection. The activator causes thepolylactic acid coatings to form a sticky putty which allowsthe granules to be applied directly through a syringe.

When in contact with blood, the biomaterial solidifiesand forms a defect-analogue, mechanically stable mass ofmaterial which is porous and will be replaced by bonetissue over time.

This occurs thanks to the fact that the calciumphosphate degrades over time, allowing bone cells togrow in and around the calcium phosphate granules asthey degrade. DS is also talking about incorporatingactive pharmaceutical ingredients into the material, such

as doxycycline antibiotics and cell growth substances.The process whereby these granules are made is an

inhouse developed proprietary process of DS. Thematerials start out as soft porous granules of tricalciumphosphate (TCP). Then using a sintering process, thegranules are hardened and coated with PLA before beingpackaged into easy-to-use kits ready for orthopaedicsurgeons.

Tissue fixation implants are injection mouldeddegradable PLA-based components for fixing tissue inplace during surgery. Processed by closely controllingcycle times and temperatures, DS manufactures a range ofdevices, including cages for spinal applications, kneeinterference screws, small pins for foot surgery, implantsfor cranioplasty and suture anchors for shoulders. In thisarea, the company offers full device development andmanufacturing services, including design anddevelopment, manufacturing, packaging, sterilisation,registration as well as development and manufacture ofthe instruments required for application.

Coloured BioresorbablesVisibility of small transparent implantable devices can

be difficult intra operatively. Coloured devices cansupport precision and quality control of the surgeon.Bioresorbable colours are another product offering of DS.The company is an expert at integrating FDA approvedimplantable colours into bioresorbable devices. The issuewith pigments in implantable devices is that there are veryfew suppliers of biocompatible colours. DS has securedthe supply of compliant pigments.

<< This is a highly magnified scCO2sterilised Dexon suture,manufactured by USA-

headquartered devicemanufacturer Covidien.

Note the scale—100 μm—on the left hand side. The

image is courtesy of DrChih-Chang Chu of Cornell

University’s Departmentof Fiber Science and

Apparel Design. >>

<< Degradable Solutions,based in Switzerland, has

developed granules (left) ofresorbable tricalcium

phosphate coated with PLA.When mixed with an

activator liquid the granulesform a sticky putty which can be injected (above) into

the body before setting to form a bioresorbable porousbone cement that allows bone to grow in and around it

as it degrades slowly over time. >>

<< Degradable Solutions isalso an expert injectionmoulder of resorbablematerials. This screw,Sysorb, is a patentedturbine shaped screw headfor reconstruction of thecruciate ligament. >>

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.

WORDS | SAM ANSON

compared with €20 bn in 2010. Despite the deceleration, 2011 wasa better year than 2009 when revenue fell by 4.3% to €18.3 bn dueto dampened demand for Germany’s medtech exports.

A breakdown of revenues into domestic sales and exportsshows that at €14.2 bn, exports during 2011 were up comparedwith 2010 by 10.6% while domestic sales grew by a slow 0.4% to€7.2 bn. As a result exports as a percentage of total revenues, at66%, was higher than the norm of 60-65% and far higher than theapproximate rate in the 1990s of around 40%.

In 2010, exports rose by 12% to a total of €12.8 bn whiledomestic sales rose by 5%.

German Medtech Export Markets Germany’s largest export destination is the EU, which in the

third quarter of 2010 accounted for around 40% of totalmedtech exports. The EU is followed by North America with ashare of 20%, Asia with 17% and the rest of Europe (non EU) with11%. The fastest growing market for German medical technologycompanies in the third quarter of 2010 was Latin America with a28% increase compared with the corresponding period a yearearlier, followed by Asia with a 26% rise. Despite being one ofthe hardest hit regions by the global slowdown, sales to NorthAmerica rose by a healthy 13%.

A Geographical Snapshot of the German MedicalTechnology Sector

A large proportion of the industry is concentrated in southGermany, primarily in the federal states of Baden-Württemberg andBavaria. There are 350 companies with more than 20 employees inthese states and impressively, these firms account for more than halfof the total turnover achieved by the entire German sector.

Approximately a quarter of revenues are generated by medicaltechnology companies in Hessen, the state which contains the cityFrankfurt, Germany’s northernmost state Schleswig-Holstein, NorthRhine-Westphalia—the state in the west whose capital is Düsselforf

and largest city isCologne, and thestate of Berlin.

GERMANY

Profile of the German Medical Technology Industry

<< Germany’s catchment areaby air, rail and road. >>


In terms of innovation, there is little doubt that Germany is theEuropean leader in medical technology. The country is the thirdlargest supplier of medical technology products and associatedservices in the world and in terms of new patent registrations it issecond behind the USA.

In 2009 the German government successfully implementedcompulsory health insurance. In 2011 it distributed photographicelectronic health cards to facilitate treatment.

German medical technology companies achieve approximatelyone third of their revenues from products which are less thanthree years old. On average, medtech companies invest a largeshare, around 9%, of their revenues in research and development.

As a medical technology market, the country is third largest inthe world after the USA and Japan and is by far the largest inEurope—twice the size that of France and three times those ofItaly, the UK and Spain. Germany’s share of global medtech salesis estimated to be 11%. The US and European markets, bycontrast, take a share of 41% and 30% respectively.

The Market for Medical Devices in GermanyGermany’s total spending on medical devices and related

services (excluding investment goods and dental prostheses) iscurrently at a total of around €25 billion a year. A further €1 bnis spent on dressings and bandages, which are grouped underdrugs.

The Medical Technology Industry’s Revenues Growth in revenue generated by the German medical

technology sector slowed to 6.9% in 2011 from 9.4% in 2010,according to official statistics. In 2011, revenue totalled €21.4 bn

<< Concentration ofGerman medtechcompanies withmore than €5 mnturnover. >>



GERMANY

Employment in the German Medical Technology SectorAccording to recent estimates, the medical technology

industry employs approximately 175,000 workers. This totalconsists of more than 100,000 people at 1,250 businesses whichemploy more than 20 employees and 75,000 employees at10,000 businesses with 20 employees or less. A further 29,000employees work in sales of medical and orthopaedic goods.

Medical technology in its narrower sense employs 137,000people in Germany, according to a study on the health satelliteaccount published by the Federal Ministry of Economics. For theyear 2005, the Fraunhofer Institute for Systems and InnovationResearch ISI calculates that the number of indirect employees ofthe medical technology sector was at 68,000. This means that eachjob within the industry provides another 0.75 jobs in other sectors.

During the years 2000 to 2008 the number of employees inthe medical technology sector in Germany rose by 12%. Bycomparison, over the same period the number of employees inthe pharmaceutical industry decreased by 4%.

As much as 15% of the medtech employees work in researchand development, also with an upward trend.

Apart from a few large companies, the medical technologysector consists mostly of medium sized businesses. As much as95% of all businesses have fewer than 250 employees. In 2010,the 1,065 medtech companies in Germany with fewer than 250employees provided jobs for around 54,000 people.

The rate of inflation in labour costs in Germany is among thelowest in Europe and is stable with an average of just 2.0% a yearduring 2000-08. By comparison, the average inflation in thetwenty seven nations which make up the EU was 1.7 percentagepoints higher than in Germany at 3.4% while in the UK it was4.9%, in the Netherlands it was 3.8% and in France it was 3.4%.

The reason given for Germany’s competitive labour supply is ahigh rate of productivity and steady wage levels. Germanproductivity rates are almost 10% greater than the average of theEU’s 15 core nations and almost 25% higher than the OECD average.

Specialisms of the German Medtech IndustryThe German medtech sector covers a wide range of product

categories—from high end specialist devices to commodity itemsfor general healthcare provision. A wide range of experience ininternational markets means that products can be easily tailoredto international customers requirements.

In a study entitled The Identification of Hurdles to Investmentin the Medical Technology Sector, published in 2008, theGermany’s Ministry of Education and Research identified somekey developmental trends in the sector.

Operational and Interventional Devices and Systems:This area of innovation includes devices and procedures foroperational interventions on the human body, meaning direct,manual or instrument based interventions.

Key themes and particularly innovative subareas in this fieldinclude minimally invasive surgery, robotics and navigation insurgery, surgical instruments, and intensive medicine.

In addition to this, networking concepts in the context ofinteroperable devices and systems play as much of a specialistrole as simple and intuitive ease-of-use. A specific feature is the

strong industrial base in Germany, primarily in the small andmedium sized family owned company sector.

In Vitro Diagnostics: In-vitro diagnostics (IVDs) consists ofinstruments and apparatus (including software) which are usedtogether with reagents for the laboratory or on-site examination ofsamples which originate from the human body. They provideinformation specific to physiological or pathological states, congenitaldefects, recipient tolerance levels, and therapeutic conditionmonitoring. In this context, important innovative subareas include lab-on-chip technology, molecular diagnostics, immunodiagnostics,decentralised diagnostics, and individualised medicine.

Prostheses and Implants: Important areas in this field includetechnical aids for the disabled and rehabilitation products,neuroprosthetics and functional electro simulation devices, as wellas intelligent and nano and bio-functionalised implants.

In terms of industry structure, prosthesis and implantinnovation is largely carried out by small and medium sizedcompanies. The sector is also characterised by a wide range oftechnology which stretches from simple mechanical systems tocomplex, active implants.

Telemedicine and Model Based Therapy: Telemedicine,or telehealth, is the name given to diagnostics and therapymeasures which make use of telecommunications to bridgelocation and time distances between doctors and patients orbetween consulting doctors.

E-health refers to specific concepts, ways of thinking,approaches and obligations towards networked and globalthinking for the improvement of healthcare using informationand communications technology (ICT).

Key themes and particularly innovative subdivisions includeelectronic patient records, telemonitoring, expert systems,ambient assisted living, and virtual reality in medicine.

Imaging Systems: In addition to classic imaging procedures (x-ray, computer tomography, magnet resonance tomographyand ultrasound), new methods such as positron emissiontomography (PET) and single photon emission tomography(SPECT) are gaining in importance.

Other important innovations include screening and earlydiagnostics, therapy monitoring, molecular imaging, multimodalsystems, image guided intervention, 4D functional imaging, andimage and data processing. Wide ranging financial measuressupporting the development of imaging procedures have beenput in place by the German government.

Device and System Networking in Healthcare Settings:In most application areas today, medical technology devices tend tobe operated as individual devices. However, the linking of medicaltechnology devices to systems and their incorporation into hospitalIT infrastructure is on the increase. This integration is creating newpossibilities in therapy and process optimisation terms.

Moreover, it also provides a complete picture of the patient’smedical history, the procedures undertaken and their current status.

By comparing the progress of previously evaluated standardprocedures with the progress of the current operation, it ispossible to acquire information about its subsequent progression.

With a workflow analysis of this kind it is possible, forinstance, to determine the forecast ending of the operation andtherefore arrange the scheduling of the next patient in optimumand timely fashion.


As German medtech firms continue to enjoy widespreadgrowth, a commitment to innovation is blindingly obvious in themedical plastics sector. The country enjoys the second highestnumber of patent registrations in the world after the USA.Medical plastics are not an outlier in this statistic. To find outwho is leading innovation in medical plastics we spoke withplastics engineer and independent consultant with twenty yearsexperience Monika Verheij.

“When looking at German innovation in medical plastics, thefirst places to look are the research institutes,” says Monika.

“Near Nuremburg we have two very important researchinstitutions which are working with medical plastics to developinnovative applications. SKZ— Süddeutsches Kunstoffzentrum(South German Plastics Centre)—is involved in a good deal ofmedical plastics research.”

An example of some of the areas in which SKZ is involved isnon-destructive testing (NDT) of test cracks in medical plasticsled by Dr Kurt Engelsing.

“The University of Erlangen’s Institute of Polymer Technology(LKT—Lehrstuhl für Kunststofftechnik) is another leading plasticresearch institute with strength in medical” Monika advises. “I met

German Medical Plastics R&D | Medical Plastics in Germany

<< The president of Rosenheim University ofApplied Sciences, Prof Heinrich Köster (left) and

Dr Karlheinz Bourdon, vice president ofKraussMaffei at the time of the opening of theuniversity’s cleanroom competence centre. >>



Research Community representatives from there at a recent SPE [Society of PlasticsEngineers] European Medical Polymers conference at Queen’sUniversity, Belfast,” she added.

Rosenheim University of Applied Science, where Monikaactually studied, is notable in terms of its expertise with medicalplastics. On January 29, 2010, the university opened what it callsa cleanroom competence centre, kitted out with KraussMaffeiinjection moulding machines. Led by Prof Peter Karlinger,students and academic researchers are able to explore futurepossibilities for cleanroom moulding.

“I met Prof Peter Karlinger at Fakuma 2012,” said Monika. “Heis in the SPE’s network of plastics engineers.”

The university at Rosenheim has had a longstandingassociation with KraussMaffei’s—one of Germany’s leadingmanufacturers of injection moulding machinery. The machineryinstalled at the competence centre in 2010 includes an EX80/380 all-electric injection moulding machine and an integratedIR 50 F/K industrial robot. For its role as a laboratory machine, theEX is equipped with a number of measuring systems capable ofcollecting data on over 100 parameters, including performance,torques and pressures.

Other German research institutes of note are RWTH Aachenon the Dutch border west of Düsseldorf and the Fraunhofer

Institute, headquartered in Munich. RWTH stands for Reheinisch-Westfaelische Technische Hochschule—the Rhein-WestphaliaInstitute of Technology.

Medical Technology Trade ShowsWhile there are no trade shows dedicated to medical plastics

(unlike the UK where Mediplas debuted in September 2012),there is a biannual medical plastics conference, Kunststoffe in derMedizintechnik, organised by the German Association ofEngineers—the VDI.

Germany hosts the largest plastics trade show in the world—K, short for the German word for plastic Kunstoff—every threeyears. In the two years when K is not taking place, the Fakumashow in Friedrichshafen, a much smaller but still sizeablededicated plastics trade show, opens its doors.

As regards medtech suppliers events, there is always a strongcontingent of plastics exhibitors at both the country’s leadingmedtech trade shows—Compamed in Düsseldorf everyNovember and Medtec in Stuttgart every Februaryor March. Monika Verheij serves on the board of directors

of the Society of Plastic Engineers EuropeanMedical Polymers Division.

GERMANY

<< These parts are mouldedin one step from two

materials—a hardtransparent outer ABS and asoft TPU ring measuring just

2.4 mm across. >>

Micro Matter: Thin Wall Aspect Ratios,Multiple Component Parts and End of Line

basically insisting that each part design and materialchoice can have its own set of rules.

The other main barrier to the success of this study waswhen resin experts were asked which materials would runa 42:1 aspect ratio at 76 μm all of them said none. Resinmaterial data sheets are often consulted to understandwhat the melt flow characteristics and what gate sizes maybe recommended. The problem is that most of thesedata sheets are developed by studying a much largerpart design and gate size. In fact most gate sizerecommendations are larger than many micro mouldedpart themselves. This is why Accumold recommends youconsult with your micro moulder before calling it quits ona project you are told is not producible. Hands onexperience with processing high temperaturethermoplastics at the micro scale beyond what the datasheet may imply is often essential to the success of aproject.

According to US micro moulding experts Accumold,simple answers to these questions are difficult to give.There are subtleties and complexities which often canonly be engineered through experience. In its basic form,the micro moulding process is very similar to standardmoulding. It still requires the ability for the mould toopen and close. There still needs to be a place to gate,eject and split the part, and concepts like draft andaspect ratio are very much still in play.

Where the process starts to divert from conventionalmoulding and what makes these questions difficult toanswer is the fact the each and every project can bring itsown set of complexities on the micro scale. When dealingwith micro sized parts how you approach elements likethe design, material selection, gate and/or parting linelocations can be the difference between success andfailure. Knowing how to approach each of these requiresa high degree of expertise and experiences notnecessarily readily available in the marketplace.

Thin Wall Aspect Ratios: Beyond Material Data SheetsThe company recommends a general guide of a 6:1

aspect ratio when it comes to applications like thin wallmoulding. However one recent Accumold study on therelationship of material choice to feature performancedemonstrated that some materials in a thin wall section(76 μm) only ran with an aspect ratio of 3:1 while othersran at 42:1. The wide variety in the response makes itdifficult to give a hard and fast rule on aspect ratio whendealing with such small features. This was also one mouldin one situation with optimal design. Other designs mayor may not perform the same way with any given material


Growing interest in micro mouldingtechnology, especially within the medical

device community, has prompted manyquestions in the marketplace. What do you

need to know about micro moulding? How isit different from traditional moulding? Are

there any guidelines? Considering thesequestions, micro moulding experts at USA-

based Accumold have written below, hopingto shine a light on these issues for design

engineers and product developers.

“Keep the creativity maximised; the impossible is done every day.”

Making Materials Work | Talk to Your Moulder Before Calling it Quits

MICRO MOULDING

<< The parts on thered backgroundare anovermouldedfabric mesh. Thedelicate fabric isautomaticallyarticulatedthrough a four-cavity mouldwhere it is cutthenencapsulated inplastic. >> << This image demonstrates the range

of parts available from Accumold. >>


Multiple Component MouldingAnother key aspect when designing for micro

moulding is knowing what other processes or value addedcomponents are available. When space is a factor, interestin multiple component parts or even part consolidationranks high. Processes like lead frame moulding, insertmoulding, two-shot moulding or overmoulding areenabling technologies and opening up a vast array ofpossibilities at the micro scale. However, adding theadditional complexities to what may be an alreadycomplicated situation requires a tremendous amount ofpre-design work and design for manufacturability.Working with your experienced micro moulder at theconcept stage is ideal for situations like this.

Traditionally one might wait until there is a part toquote before approaching a moulder. The more complexthe project, the earlier in the design phase the better.Many times a system will have to be custom built or thelead strip will have to be designed to the moulder’sspecifications so that it can articulate through the mould,possibly even be die-formed or singulated to make thefinal desired part.

A true micro moulder can overmould all sorts ofmetals, plastics, fabrics, glass, flex-circuit or anotherdelicate medium. In a general sense, most items that canwithstand the temperatures and pressures of mouldingcan be overmoulded. Keep in mind, whatever it is to beovermoulded needs a way to be held in the mould whilebeing processed. This is an often overlooked but anecessary part of the design process.

End of Line—Inspection, Measurement, Assemblyand Cleanroom Packaging

When in the early concept phase of a project it canbe easy to overlook post-moulding processes. Sometimespart handling can be equally or more difficult than themould build itself. Making the small part may be missionone, but delivering it in a manufacture-ready fashion canbe a whole new challenge not to be taken lightly. Theinspection, measurement, packaging, and/or cleanroomprocessing of a part that’s only 800 μm long can be moredifficult than meets the eye. If your incoming inspectioncan’t validate the specification or your manufacturingschemes can’t manipulate the part successfully you’ve notreally finished. Don’t overlook the backend of theprocess; it’s not always as easy as other, larger parts youmay have moulded in the past.

As a rule, reach out to your micro moulder as youembark on any project you feel will require expertisebeyond a traditional supplier. Know that micro mouldingis more than the size of the press one may have. It takesyears of experience and a high level of expertise to pulloff the most complex of projects. And most importantlykeep the creativity maximised; the impossible is doneevery day.

Accumold is situated in Ankeny in Iowa in the Midwestregion of the USA. It serves markets worldwide. Thecompany developed their micro moulding process andtechniques more than 25 years ago and is solely dedicatedto pushing the limits with micro technologies. For moreinformation on the company visit their website www.accu-mold.com. For more details on their reports or case studiesclick on Corporate Resources on the home page.

DESIGN 4 LIFE

Embedded Regulatory ConceptsLicensed to Cure allows companies to

eliminate scattered processes and data,and to embed regulations as an asset,optimising quality and compliance andreducing cost and time to market.

Single Source of InformationLicensed to Cure ensures a single

source of information that allowsmanufacturers to always get relevant, up-to-date information and establish truecollaboration with the same, accurate setof product data.

Automated TasksLicensed to Cure automates

“bureaucratic” tasks and ensuresprocedural enforcement that leads tomaking products right the first time,speeding time to regulatory approval.

Structured Process andDocumentation

Licensed to Cure provides structuredprocess and documentation such as“living” design history files (DHFs) anddevice master records (DMRs), bringingfull traceability and automated reportingand filing.

Innovation PipelineAccording to Dassault, Licensed to Cure

helps medical device manufacturersaccelerate and increase the innovationpipeline to sustain market expansion in newcountries and with specialised products tomeet patient needs without limits from riskmitigation and regulatory restrictions.

France-headquartered softwaredeveloper Dassault Systèmes has launcheda new product for medical devicemanufacturers called Licensed to Cure.

Based on Dassault Systèmes’s3DExperience design software, Licensedto Cure is said to help accelerate thedelivery of innovative, safe and fullycompliant medical devices.

According to Dassault, Licensed toCure ensures a single source ofinformation for innovation, as well as a fullytransparent and documented changeprocess allowing medical devicemanufacturers to optimise resourceallocation, maximise IP reuse, andstreamline the regulatory filing process. Bycreating an end-to-end, traceable, andcompliant product development processthat is directly linked to qualitymanagement, medical devicemanufacturers can expedite time to marketand minimise regulatory overheads.

“An increasing regulatory scrutiny isputting pressure on medical devicemanufacturers to achieve total quality andsafety,” said Monica Menghini, executivevice president, industry and marketing,Dassault Systèmes. “With the number ofFDA warning letters issued on the rise, thetime and budget that manufacturers spendon regulatory activities is increasing. Our3DExperience platform, with dedicatedindustry solution experiences, enablescompanies to manage their businessobjectives in a complex regulatoryenvironment while meeting consumers’expectations for safe products.”

In terms of individual elements, thenew software has a range of new features.

During the first half of 2012, marketresearch and analysis firm Cambashiperformed a survey of the medicaldevice and life science manufacturingsector and their suppliers. The surveywas carried out in association with USA-based UBM Canon Medical DeviceMedia Group and sponsored by Frenchdesign software developer DassaultSystèmes. In a white paper summarisingthe survey results, one of theconclusions drawn was that a quarter ofrespondents were enjoying growthwhile making major improvements intheir business performance. The paperhas drawn a profile of theserespondents, which Cambashi describesas Advancers.

Advancers, the survey says, focus onwhat customers care about whileinnovating aggressively. At theoperational level they have improved inmanufacturing, planning anddevelopment. They have implementedmeasurement, production andmanagement processes and a widevariety of information systems.

The report also pulls forward someof the strategies that appear to beeffective to achieve specific goals and tobalance trade-offs. For example, mostrespondents believe they conduct morequality process checks than arerequired, which is inefficient. To helpfocus on this and not only grow but alsoimprove profitability, companies mustmeasure and improve not just theirquality but the cost of quality and thecost of compliance.

The white paper is available fordownload from the Dassault Systèmeswebsite www.3ds.com.

Dassault Launches DedicatedMedical Device Design Software

<< The screenshotgives an idea of

the specialistmedical device

related featuresof the Licensed to

Cure designsoftware. >>

One Quarter of SupplyChain Has ImprovedBusiness Performance andGrowth, Study Concludes


MODULARCLEANROOMS

A cleanroom is a room in which the concentration of airborneparticles is controlled and which is constructed and used in amanner to minimise the introduction, generation and retention ofparticles inside the room.

Modular cleanroom constructions are typically built asfreestanding, solid and robust structures suitable for use forinjection moulding, extrusion and thermoforming environments.They are designed to be an alternative to static cleanrooms.

A modular cleanroom will use standard off the shelf proprietarycomponents that when combined with the customer’srequirements will create a 100% bespoke room, thus reducing costand lead time. Examples of customer requirements include specificISO classification, lighting and whether they want a hard or soft wall.

Modular cleanrooms use air filtration technology to reach therequired cleanroom classification. The two main types are highefficiency particulate air (HEPA) or ultra-low penetration air (ULPA)filtration. Filtration creates an exceptionally clean environment.HEPA filtration is able to remove particles as small as 0.3 μm whileULPA can handle those as small as 0.1 μm. Variable speedadjustments means that air changes in the room can be changed asrequired—maintaining quality but giving the flexibility to benefitfrom reduced energy costs during off peak times.

Cleanroom ISO ClassificationA cleanroom can be designed to achieve various ISO 14644-1

classifications of air cleanliness. ISO 14644-1 is the internationalstandard for air cleanliness for cleanrooms and associatedcontrolled environments.

Often, the type of product being manufactured will dictate theISO classification required. Long term implantable products needto be manufactured in a cleanroom with a higher standard of aircleanliness than non-sterile products which are used outside thebody. The main rule of thumb is to consider your process,determine the quality that you need to achieve using industryregulatory guidelines and if in doubt, speak to a reputablecleanroom company to gain professional advice.

Selected Airborne Particulate Cleanliness ClassesThe standard ISO 14644-1 defines the various classifications for

cleanrooms. The main criterion for classification is the maximumconcentration of airborne particles up to a certain size per cubicmetre of air. In medical plastics, typically the most stringentcleanroom class found is up to ISO class 5 while typically the leaststringent is class 8. In a class 5 cleanroom, the maximum number ofparticles permitted per cubic metre of air is as follows: 100,000 of asize which is greater or equal to 0.1 μm, 23,700 of a size which isgreater or equal to 0.2 μm, up to just 29 of a size which is greaterthan equal to 5 μm. A class 8 cleanroom, by contrast, doesn’tidentify particles smaller than 0.5 μm and allows up to 29,300particles greater than 5.0 μm in size.

Benefits of Modular Cleanrooms: Lean Manufacturing Demand for modular cleanrooms is on the increase as more

processes, particularly in the medical plastics sector, are benefitingfrom a cleanroom environment. With this demand comes a costand companies are obviously going to look for the best solution tofit their needs and budget. Due to recent years of cut backs thatmany industries have witnessed, small, medium and largeorganisations have had to re-think their company strategies andbecome leaner in the way they manage processes. Modularcleanrooms are part of that leaner way of thinking, as contractmanufacturers are finding they can dramatically increase their scopeof work by introducing cleanroom facilities.

With traditional build cleanrooms, retrospective modificationsare often a lengthy and costly process, so future demands must beaccounted for in the initial specification. Modular solutions aremore flexible as expansions and relocations can be accommodatedmuch more easily. In these uncertain times companies are seeingthe fact that they can stagger their investment to grow with contractwins or developments as a real benefit.

Dramatic design improvements have also led to an increaseddemand for modular cleanrooms. The use of clear, solid wall panelshas led to an improved perception of the modular design ofcleanrooms. They are no longer seen as the temporary, low budgetoption and now offer a reliable and robust alternative to thetraditional build cleanrooms.

Hard or Soft Wall and Entrance Control Modular cleanrooms are available as hard and soft wall options.

Hard wall modular cleanroom options are manufactured from clearpolyethylene terephthalate. This material is aesthetically pleasingyet limits access to the cleanrooms while allowing in light andensuring that processes can be overseen.

Softwall options are also aesthetically pleasing, ensure minimumopening only when entering or exiting the cleanroom, maintain theintegrity of the room and are a low cost investment. A modularcleanroom can be housed within a dirtier area, for example awarehouse, and still maintain their ISO integrity.

Tacky mats outside the cleanroom remove dust particles fromfootwear and changing rooms can be built within the modularcleanroom to ensure that the user can change into cleanroomapparel in a controlled environment prior to entering thecleanroom.

By including a mid-height rail to a softwall cleanroom enclosure,you can direct people to adedicated entrance andprevent people fromentering the cleanroom at anypoint thereby maintaining fullcontrol of access. Mid heightrails also offer extra strengthto soft wall cleanrooms.

The Versatile World of Modular CleanroomsBY SEAN FRYERS, MARKETING MANAGER AT CONNECT2CLEANROOMS


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.

SummaryWhatever cleanroom solution is chosen, an investment is being

made 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 ofmodular cleanrooms in

Holland, Latvia and the UK. >>



DOCTOR’S NOTE

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-art three-dimensional digital breast tomosynthesis (DBT), alsoknown as 3D tomo, is helping clinicians achieve even more accuracyduring scanning.

Implementing DBT scanning equipment in UK hospitalsrequires 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.

In order to test the equipment, operators use phantoms—flatacrylic plates which are designed to mimic the properties of thebreast tissue—to ensure that the equipment is functioning properlybefore the x-rays can be taken.

A UK-based team of research physicists at The Royal SurreyCounty Hospital in Guildford, UK, are in the process of type testingnew DBT machines. The team is part of the UK’s National Co-ordinating Centre for the Physics of Mammography.

They are using phantoms manufactured specially for 3D DBTmachines by UK-based plastics machining expert Carville. Carvillehave supplied phantoms to the NHS for 2D equipment as well asradiology delivery devices for many years.

The phantom used for the 3D equipment is made from a castacrylic. Acrylic is ideal for the phantoms because it has very similarattenuation characteristics to human tissue and can be used invarious thicknesses—between 20 mm and 70 mm—to simulatehuman tissue when x-ray performance is being calibrated.

The acrylic is stressed and fully normalised (heat treated) toremove this internal stress. The material is then diamond machinedand polished to produce clear flat plates. The latest acrylicphantoms contain 25 aluminium balls with a diameter of 1 mm

arranged in a square grid arrangement in the centre of the acrylicplate. The balls are arranged 55 mm apart in a rectangular array,the distance being accurate to within 100 μm (0.1 mm). The reasonfor specifying this precision in positioning the balls was so that theimages could be used to evaluate geometric distortion.

Carville is able to achieve these high levels of accuracy byencapsulating the balls between two plates and then bonding thetwo plates together using a proprietary diffusion bonding process.According to Carville, the process ensures a seamless joint as if thephantom was produced as a solid block. The dimensions of thephantoms are 300 mm x 240 mm x 5 mm.

These phantoms are being manufactured by Carville now andwill be used by 13 regional health authorities in England and Waleslater this month.

Carville has also manufactured a block of acrylic containing justone aluminium ball with a diameter of 1 mm. The single ball in theblock allows radiographers to test a feature with a particular densityand shape in order to perform a regular check on theirtomosynthesis images.

Medical Plastics News would like to thank Celia Strudley at theRoyal Surrey County Hospital NHS Foundation Trust in Guildford,Surrey, UK.

Machined Plastics Help PhysicistsTest Performance of 3D Digital BreastTomosynthesis Imaging Equipment

<< Carville manufactures a number of phantoms for theUK’s state-funded National Health Service (NHS). One ofthe specialist skills here is the inclusion of aluminiumballs positioned to the nearest 0.1 mm using Carville’sdiffusion bonding process. >>


Drug Contact Plastics | Cyclic Olefin Additives

Colours and Additives for Cyclic OlefinsEnable High Tech Bioactive Drug Delivery

Interview with Steve Duckworth, head of medical andpharmaceutical at Clariant’s masterbatch unit.

The overlap in technologies across traditionalmedical instruments and drug delivery devicesis gaining prominence. Healthcare providersare on the look out for more innovativemechanisms from drug companies to allow asmany patients as possible to treat themselvesfrom home, thereby saving hospitalexpenditure. Being inert, durable, low cost,lightweight and colourable, plastic is thematerial of choice for designers of thesemechanisms, particularly as new biotech drugformulations enter the realm. Ahead of nextyear’s Pharmapack show in Paris on February13-14, Medical Plastics News interviewed SteveDuckworth, head of medical andpharmaceutical at Clariant’s Masterbatch unit.

Sam Anson: Looking at the name Pharmapack in a literal sense,readers might be forgiven for thinking that the exhibition is only fortraditional packaging products like drug blister packs, fluid bagsand disposable films. But they’d be wrong wouldn’t they?Steve Duckworth: Absolutely. The show is more important thanthey might initially realise. Despite the name, approximately half ofthe people there are involved in drug delivery devices. And it’sreally worth visiting. Being in Paris, the show attracts people from allover Europe. And it’s a really nice format too.

Sam Anson: You’re not the first person to recommend it. Whatcan visitors expect to see there from Clariant?Steve Duckworth: Clariant will have two stands. A team fromPerformance Packaging, part of the Functional Materials businessunit—formed following Clariant’s acquisition of Süd Chemie in2011—will be there to talk about desiccant and barrier packagingsolutions used in both primary packaging of pharmaceuticals andsecondary packaging products for drug delivery devices, whichhelp protect sensitive products from oxygen and waterdegradation.

Sam Anson: And what about Clariant’s Masterbatch unit?Steve Duckworth: On our stand, number 333, we will befocusing on our recently introduced range of Mevopur USP/ISOcompliant additives aimed at improving the final product or theproductivity.

Sam Anson: I heard that you are working closely with Topas andtheir cyclic olefins. Can you tell me a little more about this?Steve Duckworth: Topas cyclic olefin copolymer is a veryinteresting material from a number of stand points but particularlyits clarity combined with rigidity. It is clear like glass. This makes itideal for the replacement of glass in syringes or ampoules.

Sam Anson: I was told that syringe and ampoule manufacturershave the biggest appetite for cyclic olefins. What is driving this?Steve Duckworth: Demand is being fuelled by three factors. First,there are safety concerns related to breakages of glass-basedsyringes during transportation. The Topas olefins are shatterproofso there’s more durability there. Second, the fact that plasticsyringes and ampoules can be injection or blow moulded givesopportunities for reduced costs while maintaining high clarity.Third, injection moulding also gives options for designers to beginto think about newer and more intricate shapes.

Sam Anson: According to a report published by USA-basedconsultancy firm Greystone Research Associates in April 2012,demand for prefilled syringes is expected to grow at double digitrates to 4.75 bn units in 2016. The report says that cyclic olefins area “material to watch”. How is Clariant helping to supply thisdemand?Steve Duckworth: Working with Topas, we have developed anumber of standard colorants and additives for cyclic olefins. Twoto note are our UV filters in amber and pink and our additivewhich can prevent yellowing following up to two rounds of gammasterilisation. Both technologies have been developed from triedand trusted technologies.

Sam Anson: Tell me about the UV filtering first.Steve Duckworth: Some contents of prefilled syringes andampoules, particularly new ‘biologic’ products can be highlysensitive to light and thus need to be protected using a colorantwhich filters out UV light. Clariant already manufactures a range ofUSP grade amber and pink colorants for polyolefin-basedampoules and syringes. We have worked with Topas and havedeveloped USP/ISO pre-tested pink, amber and other colours


PHARMAPACK 2013

which 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 aline malfunction for example they can do so without issue fromClariant’s gamma testing. That said, Topas do not recommendrepeat sterilisation in general.

Sam Anson: Fascinating. That’s advanced thinking. As a leadingsupplier of colours for plastics, you must have a privileged view ofhow things are changing in this area for USP/ISO materials. Steve Duckworth: I do. And things are changing quickly. Just overa year ago I said to Medical Plastics News that I thought colours arecoming. And that trend is certainly showing no signs of abating. Forexample colour coding has become a key aspect to device design,particularly in drug delivery. For example a new generation ofinsulin treatment offers patients the opportunity to only require asingle daily injection, replacing insulin which required three or moredoses a day. The insulin is typically self-administered by aconvenient pen device However, manufacturers are concernedthat despite labelling, patients may mix up these devices andmistakenly give themselves an insulin overdose by injecting thesingle dose more than once in a day. Their solution to this is to use

bright colours to safely differentiate between the two pens tominimise the risk of a mix up.

Sam Anson: What additives are you offering which help plasticprocessing?Steve Duckworth: A popular product range is our USP/ISO laseradditives for marking and welding that comes with USP Class VIcompliance. Of particular interest is the welding additive. It allowsclever things to be done with the design, offers more reliability thanadhesives and eliminates the potential problem of residues. Also aspart of this range we offer UPS/ISO nucleants to help reduce cycletime, optimise wall sections and solve production problems.

Clariant will be at Pharmapack on stand 333.

<< At Pharmapack 2013 Steve Duckworth will be talkingabout Clariant’s Mevopur range of USP Class VI approvedadditives and colorants, including those which arecompatible with Topas’s cyclic olefin copolymers. >>


Understanding Chemical InteractionDuring Material SelectionBY JOY HARRISON, PRINCIPALCONSULTANT AT PLASTICSTESTING AND ANALYSISCONSULTANCY SMITHERSRAPRA, UK.

There are many factors to take into account in choosing the right plastic material forpharmaceutical packaging applications and successfully converting it to the finished

product. Joy Harrison summarises the main considerations for producing packaging ofappropriate quality which compliments the pharmaceutical product.

PHARMAPACK 2013


Source: Topas.



PHARMAPACK 2013

Drug Contact Plastics | Extractables and Leachables

Smithers RapraForecasts Medical PlasticsMarket Growth

In a new report published bySmithers Rapra, sales of medicalplastics are forecast to grow rapidly,particularly in developing regionssuch as Asia and Latin America,boosted by rising demand forsophisticated medical devices andimproving medical care. The forecastsare part of The Future of SpecialtyPlastics: Market forecasts to 2017.Looking at the contents, the reportcovers specialty medical gradematerials such as ABS, COC, LCP, PC,PEEK, PEI, PET, PMMA, POM andPSU/PES. In terms of specificapplication areas, the report focuseson medical device housing, fluidtransfer systems, opthalmics, surgicalinstruments and other medicalequipment.


The key requirements forpharmaceutical packaging materials arethat the packaging contains, protects andprevents deterioration of thepharmaceutical product during storage,transportation and possibly in use.However, the packaging material must notcause any adverse effects to thepharmaceutical substance which render itless effective in its function or render theproduct harmful.

Understanding Interactions Betweenthe Plastic and the Pharmaceutical

The most important consideration isthat there should be no chemical reactionbetween the pharmaceutical substanceand the packaging material. Developersmust ascertain that there is chemicalcompatibility and stability over theproduct’s shelf life at the stated storageconditions.

Interaction between thepharmaceutical substance and thepackaging materials can take severalforms, some more obvious than others.

In the most severe case, the substancemay attack the packaging material suchthat the integrity of the packaging isbreached. Such a material would beclearly unfit for purpose.

The substance may attack thepackaging, causing plasticisation andsoftening of the packaging, leading todimensional instability. In addition thepackaging material could contaminate thepharmaceutical material.

All plastic materials contain an additivepackage which will include thermalstabilisers to enable processing. Elementsof the additive package may leach outwith time in contact with thepharmaceutical product. The amount thatmay be acceptably transferred to theproduct will depend on the nature of theadditive and potential toxicity.

Flexible materials often contain oilsand plasticisers, some of which have ahigh propensity to migrate to contactingsubstances. The plasticiser itself may bedeemed harmful and loss of the plasticiserwill lead to the packaging becoming morestiff, brittle and prone to accidentaldamage.

Furthermore, in Europe, as the REACHregulations continue to change, awarenessand careful selection of the plasticisersystem is essential.

SterilisationSterilisation of the packaging is

sometimes required. Radiation, steam andethylene oxide techniques are commonlyused. Irradiation is preferred as it is muchquicker but is another potential source ofmaterial degradation. Ethylene oxide ismore innocuous to the plastic packagingbut can leave harmful residues.

Manufacturers of polymer resins andcompounds for packaging are, of course,aware of these issues. Grades of materialare produced, with reduced or tailoredadditive packages, specifically aimed atapplications which are in contact withpharmaceuticals, as well food and medicaldevices. Superior resistance to irradiationmay be another feature. These grades areusually subjected to additional qualitycontrols and have undergone extensivetesting. These materials may berecognised by FDA food contactcompliance or USP 88 Class VI claims.

In addition, processing may change theplastic material. For example if the materialis overheated during processing,degradation substances may be producedwhich are toxic or carcinogenic in natureand therefore extremely undesirable.

Steps for Selecting a Drug ContactPlastic

The key steps in selecting a plasticspackaging material and ensuring itssuitability for the application may besummarised as follows.

Select a material type where there is aminimal amount of known primarychemical interaction between thepharmaceutical substance and material.

In terms of the grade, selecting onewhich has been tailored for use in food ormedical applications is a wise choice. It isrecommended that you discuss yourapplication with a technical representative ofthe manufacturer. The manufacturer knowsthe formulation of his material and should bewell placed to advise on the grade and ifthere are any potential problems.

Process according to themanufacturer’s guidelines and avoidmaterial degradation at all costs.Remember that the material probably hasa reduced stabiliser package compared tostandard grades.

Contamination by other materials mustbe avoided. This may arise after changingmaterials in the moulding equipment.Production in a cleanroom is oftendeemed necessary and many mouldersoffer this service.

Where sterilisation is required, select aplastic type that will withstand the chosensterilisation technique or select atechnique that is compatible with theplastic to avoid excessive degradation.

Carry out extractables and leachablestesting on the moulded product incontact with the pharmaceuticalsubstance. The material supplier may beable to advise which substances must bequantified.

More than Packaging:

At thePharmapackconference and exhibitionin Paris in February 2013, UK-based medical device developmentconsultancy Team Consulting will be showcasing concepts forhow packaging of medical products can improve usability andmake essential products like auto-injectors and inhalers moreappealing to the patient. Team is seeing demand for theirservices go beyond the design and engineering of the deviceitself to the wider patient experience and has responded withinnovative ideas which take packaging “outside the box”.

“It has always been the case that devices have to be safe, butwith new regulations around human factors over the last fewyears, the devices also have to be proven to be usable,” explainsTeam’s director of design Paul Greenhalgh. “This focus on safetyand usability is opening the market up to some reallyencouraging innovation around how you make medical devicesmore usable, and how we can make them even more appealingto patients. We are all aiming for greater patient adherence andby tackling the big issues around why patients aren’t complyingwith their treatment we can make some improvements”.

The firm says that this is now leading them and otherpioneers in the medical devices space to think about all aspectsof the patient’s interactions with the device, such as theinstructions, the packaging, the device itself and supportive aidslike mobile apps.

“We are working with our pharmaceutical clients to improvetheir IFUs (instructions for use) and this led me onto theseconcepts for device packaging,” explains Team’s David Robinson,


Packaging Design | Interactive Aesthetics

<< Team Consulting’s designconsultant David Robinson said thathis inspiration for this innovativeinjector pen packaging came fromonline videos where consumers filmthemselves unboxing, or opening,the latest piece of technology. >>

Team Takes Drug Delivery Outside the Box


a design consultant. “I’d seen ‘unboxing’ videos online, whereconsumers film themselves opening that latest piece oftechnology, and I thought about whether we could use the sameprinciples in our clients’ packaging.”

The result, according to Team, is that it could really helppatients to understand how to use their device correctly. Thiscould help reduce anxiety in patients and, in some cases, evengenerate some levels of excitement.

At Pharmapack, Team will be showcasing its concepts anddemonstrating what is possible if the industry thinks creativelyand actively challenges the status quo.

Robinson explains, “Think of them as pop-up books. Theauto-injector or inhaler sits behind a thermoformed plastic andcan be seen through a cut-out in the instructions. As each page isturned to access the device, information is presented to users inbite size chunks, firing their ‘mirror neurons’ as they explore thedevice, intriguing and delighting them, and drawing them furtherin.”

Team seems to take great delight in challenging the sector tothink about their devices as more than just the packaging aroundthe drug. As they’ve said a number of times during our discussion,the device is the interface between the drug and the patient, andthe packaging and peripherals are an extension of this.

“Medical devices are prescribed by doctors; patients don’tchoose an inhaler or injector pen as they would a smartphone ortablet computer. There is usually a lot of anxiety and concern aspatients get their heads around their treatment regime and ofcourse the enormity of any condition that they have beendiagnosed with. Anything that we can do to reduce this—evenslightly—is well worth doing,” Greenhalgh concludes.

PHARMAPACK 2013

“Think of them as pop-upbooks. As each page is

turned toaccess the

device, information ispresented to users in bite

size chunks, firing their‘mirror neurons’ as they

explore the device,intriguing and delightingthem, and drawing them

further in.”

Declared a great success by attendees and organisers alike,Vinyltec 2012 boasts 165 conference attendees, 25presentations, a stellar slate of exhibitors and sponsors, 13 newSociety of Plastics Engineers (SPE) members as well as 3 keynotespeakers including SPE President Jim Griffing with the BoeingCorporation. In addition, the one-day pre-conference seminarhit record attendance with 78 seminar attendees. The strongconference attendance again this year is consistent with numbersdelivered the previous two years: 166 in 2010 and 151 in 2011.

With Versatile Vinyl Plastics: Formulating for the Future thefocus of this year’s conference, presenters addressed a range ofPVC topics including plasticisers, phthalates, sustainability, safety,performance, recycling and regulatory update. In his keynote,Formosa’s Plastics USA’s Brad Esckilsen delivered a Resin MarketUpdate while Kevin Ott of Flexible Vinyl Alliance recappedFlexible Vinyl Business Issues.

Injecting medical plastics into the conversation, Len Czuba(pictured top right) presented Flexible PVC in the MedicalDevice Industry—A Review of the Concerns Related to Its Use,introducing the idea that if a specific patient population isadversely affected by phthalate plasticisers, it may be prudent toavoid exposing that segment of users to DEHP. However, Lensaid that 40 years of proven safety and effectiveness shouldcontinue to justify the use of DEHP plasticized flexible PVC inmedical devices for the majority of users, the non-affectedpopulation.

Sponsored by SPE andSPE Vinyl Plastics Division,this year’s conference washosted by the ChicagoSection EducationalFoundation. Held at thevery newly renovatedMarriott O’Hare Chicago,Vinyltec 2012 attracted engineers, technicians,researchers and managers involved in the PVC product valuechain. Looking forward, Iselin in New Jersey will host next year’sVinyltec on October 21-23, 2013.

Jodie Laughlin, amember of the SPE for 14years, is vice president ofSPE Chicago SectionEducational Foundation,serves on the board ofdirectors of the SPEMedical Plastics Divisionand is channel director,alternative distributionwith GE HealthcareAmericas.

EVENTS

medical plastics | DIARY 2012/13

10th Indian Medical Devices &Plastics Disposables conferenceJanuary 12-13, 2013Ahmedabad, India

Medical devices and health insuranceconferenceJanuary 15, 2013Berlin, Germany

Polyolefins conferenceJanuary 30-31, 2013Amsterdam, The Netherlands

SPE Conference Success: Vinyltec 2012 in ReviewBy Jodie Laughlin

Ireland Medical TechnologyExcellence AwardsDecember 13, 2012Galway, Ireland

Plastics trade showJanuary 7-10, 2013Dubai, UAE

Polyolefins conference February 24-27, 2013Houston, Texas

Medtech trade showFebruary 11-14, 2013Annaheim, California, USA

Drug delivery and packagingtrade showFebruary 13-14, 2013Paris, France

Medtech trade showFebruary 26-28, 2013Stuttgart, Germany


Medical Plastics News November-December 2012

Documents

mpn medical plastics

medical plastics diary

digital medical plastics

medical plasticsto

aknowledge of medical

lot ofat medical plastics

plastics contents

drug contact plastics