MPN EU Issue 14

MPN

MEDICAL PLASTICS NEWS

COUNTERFEITING: ARE YOUR DEVICES AT RISK? Plastics Protecting Intellectual Property Against Illegal Fakes

ALSO IN THIS ISSUE: US-EU Regulatory Harmonisation Injection Moulding K Show and Mediplas Previews Minimally Invasive Devices and Diagnostics Alternatives to Animal Testing

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Contents

Regulatory harmonisation?—Page 7 Cover story—page 10

5. Editor’s Letter: Repeat sterilisation Sam Anson asks if we can develop an additive which can provide a clear indicator of a polymer’s sterilisation history.

6. On the Pulse: Industry news UK experts criticise proposed EU device regulations, industry applauds EU-US trade pact, 3D printed resorbable tracheal splint successfully implanted into baby, and New York Times US healthcare cost analysis.

10. Cover: Anticounterfeiting PolyOne present the case for protection against counterfeiting in medical devices and how plastics can help reduce risk.

13. MD&M East: Thought leaders Eight thought leaders convene at the MD&M East trade show in Philadelphia to discuss what makes the east coast of the USA a medtech powerhouse.

Injection moulding—page 18

Transparent polyamide—page 28

18. Clean Machines: Injection moulding Fundamentals of moulding complex thin walled bioresorbable polymer parts and news in processing and equipment and mould design and manufacturing.

26. Material Diagnosis: Engineering polymers Results of tests to analyse PMMA polymer chain scission following gamma sterilisation, high flow PMMA and transparent polyamide, new PC/ABS blends, polymer hardening agent and applications of sulfone polymers.

34. Folio: Glucose meter Glucose meter image supplied by Styron.

37. Design 4 Life: Design news Multiple sceloris monitor and orthopaedic clamshall package.

38. Regulation Review: Material selection Selecting thermoplastics with ISO10993 history for best regulatory compliance.

41. Doctor’s Note: Animal testing Dr Laura Waters presents alternatives to animal testing in pharmaceuticals following the EU ban in cosmetics.

42. K Preview: Plastics The world’s largest plastics trade show, held once every three years, opens its doors in October 2013.

49. Mediplas: UK medical plastics The only trade show dedicated to medical plastics will be held alongside established additive manufacturing event TCT in Birmingham in September.

54. Product Focus: Minimally invasives and diagnostics Cryoblation catheters, lubricious compounds, OEM roundup, cell classification and microfluidic moulding fundamentals.

63. Coatings: Roundup Antimicrobial parylene and more.

66. Events: August-September 2013 Diary and EuroTec review.

Online and in digital Minimally invasive devices—page 57 Disclosure: Medical Plastics News may charge an undisclosed fee to place a contibutor’s image and headline on the front cover.

Medical Plastics News is available online at our brand new website www.medicalplasticsnews.com and via a digital edition.

JULY-AUGUST 2013 / MPN /3

EDITOR’S LETTER

CREDITS

Repeat Sterilisation: Can We Develop Polymer Additives That Provide Clear Indications Of A Device’s Sterilisation History?

editor | sam anson

T

Sam Anson

advertising | gareth pickering the sufficiency of the process. his question is in An example of this is common response to issues autoclave tape. Beyond which have been autoclave tape, such reported to me whereby indicators also exist for hospital sterilisation nitrogen dioxide, ethylene departments put single use oxide and hydrogen peroxide plastic devices through more sterilisation processes.” than one sterilisation cycle, Dr Opie goes on to say: often accidentally but “Better control of the sometimes in an effort to save sterilisation processing of costs. devices may result from two Explaining one half of the improvements. The first problem, one source told me: would be the implementation “Some hospitals have unofficial Source: Julian Brown press and public of practices that result in lists of devices intended for relations photogtrapher, courtesy of UKbetter control of products. single use that they actually rebased charity Shelter.

For example, requiring that sterilise or clean for repeated any product exposed to a sterilisation process use. For instance, it was reported to me that in has a new, unexposed chemical indicator.

Brazil dialysis sets would often be cleaned and Products that cannot be exposed to more than reused after contact with more than one patient, one sterilisation cycle should be controlled in which obviously creates a major risks related to this manner.” recontamination and the spread of blood Dr Opie added: “The second improvement transferred diseases. We know that unoffical lists could be, as you describe, integration of the for the reuse of single use devices also exist in chemical indicator chemistry with the product.

Europe.”

One could consider that the chemical indicator Sometimes, hospitals may accidentally chemistry could be printed directly on the repeat sterilise devices using more than one medical device. Additionally, and theoretically, method, so for example steam and gamma the chemical indicator chemistry could be radiation. So detecting the possible integrated into the polymers used in the combinations is difficult. product. So long as the application of the In an attempt to curb this practice, some chemical indicator chemistry into the medical device manufacturers are using materials which device does not change the function or safety degrade upon a second sterilisation cycle. But of the device, this is feasible. We must be this may present a further risk if the actual mindful that this improvement requires that the polymer degradation is not obvious to the eye, package has a transparent window so that the as it may cause the device to fail when in use. hospital staff is able to see the indicator portion Having an additive technology which of the product within the package. Furthermore, provides an indication of the number of hospital procedures must dictate that these sterilisation cycles that a material has been critical products are inspected prior to exposed to, by changing colour, would be sterilisation to ensure that the product has not desirable for device makers and the industry as been exposed.” a whole.

If we look at other sectors, there are The ideal solution would be to develop a examples of colour changing compounds range of indicators, which could be in the form around. Thermochronic (temperature senstive) of an additive to allow it to be integrated pigments have been integrated into plastics and directly into a moulding or tube, without it epoxy resins by a number of researchers, affecting the mechanical performance of the although I am not aware of any evidence of any base material. The solution would involve biocompatibility testing of these pigments. indicators which were sensitive to the main Other colour changing technologies include forms of sterilisation—EtO, steam and gamma water absorption and levels of carbon raditation. It would also be able to indicate the monoxide and carbon dioxide levels in the air. level of sterilisation that a material has been Dr Opie closes with: “For products where subjected to—or in other words the number of the control of repeat sterilisation processing is each type of sterilisation cycle it has been critical, coordination between product through. designers and sterilisation personnel is I asked Dr David Opie, senior vice president necessary. Designers need to design the medical for R&D at US developer of nitrogen dioxide device and packaging so that reasonably simple sterilisation technology Noxilizer to comment. control procedures are possible. This He said: “There are many Class 1 chemical coordination with hospital personnel will then indicators which indicate that the chemical lead to the best implementation of the best indicator has been exposed to the target chemical indicator solution.” process. This class of indicator does not indicate

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JULY-AUGUST 2013 / MPN /5

Industry News | ROUNDUP

EU Proposals on Medical Device Regulation Do Not Go Far Enough, Say Experts Respected experts from the UK’s National Institute for Health Care Excellence (NICE)—a UK body which produces guidelines for clinicians on best practice in medical treatments—have called for a more robust regulatory environment in Europe in a recent article in the BMJ—the British Medical Journal.

In particular, they say that the current proposals do not go far enough in terms of device tracking (to help trace patients and to recall devices), improved coding for new procedures, use of registers and data linkage, and better post-marketing surveillance. The call may be seen as a blow to the Don’t Lose the 3 campaign—an initiative by Eucomed, Europe’s medical device industry association, to persuade the European Parliament to oppose the proposed scrutiny procedure for certification of high risk devices contained in the new regulations.

The experts argue that developing more detailed systems will help healthcare companies produce observational data that would enhance the safety of devices and procedures while facilitating clinical decisions about a device’s place in healthcare.

Eucomed oppose the scrutiny procedure because they say it will slow down the approval process for highly innovative devices, meaning that European citizens will lose the benefit of having these devices at least three years before people in other parts of the world.

Medical Plastics News is not aware of any publicly available information which contains

May 16, 2013 DePuy Discontinues Ultamet and Complete Metal-onMetal Implants

estimates of how much it will cost to implement changes required to set up the regulatory infrastructure involved in making the improvements, nor how this would be financed.

In an accompanying commentary, a research group led by Edmund Neugebauer a medical professor at Herdecke University in Cologne, Germany, argues that Europe needs “a central, transparent, and evidence-based regulation process for devices.”

Last month, they submitted a petition to the European Commission, European Parliament, and European Council asking for “enforced rigorous clinical evaluation of medical devices” setting out three main requirements for an updated European regulation process.

They want to see centralisation of the regulation process and independent assessment “by a new public body similar to the European Medicines Agency”.

They also recommended that patient safety should be improved by requiring high quality evidence of patient relevant benefits. Postmarketing surveillance should also be compulsory “to ensure that benefits and harms of the device in real world settings are similar to those shown in clinical trials.”

They call for transparency of the assessment process, saying the European Databank on Medical Devices (Eudamed) “should be publicly accessible and should include all relevant information concerning assessment, including data on safety, performance, and incidents.”

Recent Regulatory Issues: According to medtechinsider.com, medical device manufacturer Ceraver has sold artificial hip replacements that had not been properly certified. Medtechinsider.com quotes French newspaper Le Parisien as the source.

Qmed.com has reported that UK newspaper The Daily Mail has published that Swedish health authorities have urged the immediate removal of all substandard breast implants manufactured by PIP. The action by the Swedes follows similar moves in the Czech Republic, Germany and France. The founder of PIP is facing up to four years in jail if he is found to be guilty of knowingly manufacturing substandard implants. Four other PIP executives have also been tried. The trial took place in a court in Marseille, France. The verdict will be delivered in December 2013.

In the USA, the FDA has written a warning letter to the chairman and CEO of Medtronic to inform him that it has refused entry of imports of two Medtronic catheters from Italy. The catheters are the Amphirion Plus PTA and the Diver CE PTA angioplasty products. The FDA cites nonconformity to good manufacturing practice requirements by the plant in Italy uncovered during an inspection, followed by unsatisfactory follow up actions.

Medtronic are recalling its NIM Trivantage EMG endotracheal tube. The tube is used by healthcare professionals to continuously monitor the voice box (laryngeal) muscles during surgery.

The device keeps the patient’s airway open for

May 18, 2013 Month-long French Hearing to Try PIP Founder and Executives for Fraud Ends Jean-Claude Mas, a former travelling salesman who got his start in the medical business by selling pharmaceuticals, founded PIP in 1991 to take advantage of the booming market for cosmetic implants.

May 22, 2013 3D Printed Bioresorbable Splint Implanted into Baby’s Trachea Other discontinuations will be announced in 2013-14.

Advancements in polyethylene bearing technology contributed to this decision.

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Scott Hollister, PhD, professor of biomedical engineering and mechanical engineering and associate professor of surgery at the University of Michigan, where the splint was made and implanted, said: “It takes about two to three years for the trachea to remodel and grow into a healthy state, and that's about how long this material will take to dissolve into the body.”

June 4, 2013 BASF Announces EUR10 BN Investment in Asia in 2013-20 Dr Martin Brudermueller, vice chairman of the board of executive directors of BASF, said: “With our Asia Pacific strategy, we are positioning BASF as the leading provider of sustainable solutions for the Asia Pacific region.”

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Industries Applaud US-EU Trade Negotiations, Step Closer to Regulatory Harmonisation ventilation and for electromyography (EMG) monitoring of the laryngeal muscles when connected to an appropriate EMG monitor.

The recall follows complaints of “cuff leak or cuff deflation, occurring when the inflation valve cap is inappropriately removed—for example pulled off, instead of snapped-off sideways”.

According to the FDA website, this issue requires the physician to re-inflate or replace the deflated tube to ensure the continued breathing support of the patient. The FDA warns that use of the product could result in serious adverse health consequences..

According to a report on news site Bloomberg Businessweek, CR Bard officials knew some of its vaginal mesh devices were made of a plastic deemed unsuitable for human implantation and hid that flaw from doctors and nurses who used the product, a lawyer has said. The statement was made in a court in West Virginia, USA, during the first day of a trial in which a woman is suing CR Bard because she had to undergo several surgeries to remove the mesh, which had been implanted as part of CR Bard’s Avaulta Plus device to buttress organs that were collapsing into her pelvic region. The claimant says the mesh had to be removed after she began suffering pelvic and rectal pain, bleeding and bladder spasms. The report goes on to state that Bard faces at least 3,600 claims over its Avaulta Plus vaginal mesh.

The report states that plastic used for the mesh carried a warning that the device shouldn’t be permanently implanted in people.

Leading US and European industry associations have publicly applauded the announcement to launch US-EU trade negotiations. This is according to an announcement by MedTech Europe, the body representing Europe’s manufacturers of medical devices and diagnostic instruments. The announcement was made immediately after the G8 summit of leading heads of government in Northern Ireland in June 2013. The US associations include AdvaMed (medical device manufacturers) and MITA (US medical imaging technology alliance). The European ones are Eucomed (medical devices) and EDMA (diagnostics) via their new umbrella association MedTech Europe we well as COCIR (radiological, electro-medical and other IT and communications technologies).

A key driver behind the industry’s interest in these negotiations is to encourage regulatory alignment between the USA and the EU. Harmonisation between the two markets would make it easier for the associations’ members to do business on both sides of the Atlantic.

While harmonisation with US regulations would make exporting companies’ operations simpler, there are components of the US systems which are more stringent than those currently in force in the EU. But Eucomed is lobbying against the scrutiny procedure, a process more akin to the US system, as part of its Don’t Lose the 3 Campaign (see page 6). Medical Plastics News asked Eucomed to explain the apparent dichotomy between, on the one hand,

supporting regulatory harmonisation with the USA—a system known for its conservatism and increasingly longer waiting periods for approvals—and, on the other, arguing that scrutiny procedure is too stringent for no benefit and is likely to slow down approval time and stifle innovation.

Eucomed’s response was as follows. “While it is true that Eucomed does not believe that Europe should move towards a centralised premarket authorisation system for the approval of medical devices like the one used by the FDA in the USA, we believe that regulatory convergence in several other areas would be of mutual benefit to patients, healthcare systems, industry and medical device innovation. Eucomed is working with transatlantic partners to urge US and EU authorities to work toward the inclusion of single audits of medical technology manufacturer quality management systems, a single harmonised standard for marketing application format and unique device identification (requirements for marking/labelling and the unique device identifier (UDI) database) in the final agreement.

Eucomed believes concerted efforts on these fronts will lead to expanded US-EU trade and investment and facilitate medical device innovation on both sides of the Atlantic.

Representatives from the associations met with senior US and EU government officials in April 2013 to present the arguments for regulatory convergence, focusing on ISO13485, a single audit process, harmonised product registration and a common traceability process.

PREVIOUSLY ON MEDICALPLASTICSNEWS.COM June 11, 2013 Japanese Clinical Trials Begin in Japan for Absorb Resorbable Vascular Scaffold Principal investigator Takeshi Kimura, MD, professor at the department of cardiovascular medicine, at Kyoto University Hospital, Japan, said: “Unlike permanent metallic stents, Absorb dissolves over time, which may allow the blood vessel to regain natural function, a unique effect that could have significant impact on the way coronary artery disease is treated in Japan.”

June 18, 2013 Industries Applaud US-EU Trade Negotiations, Step Closer to Regulatory Harmonisation “We enthusiastically support this opportunity, and look forward to concrete developments in the coming months that will further enhance our transatlantic economic relationship” said Serge Bernasconi, chief executive officer of MedTech Europe. Image source: Official website of the White House.

29:07:2013 June 27, 2013 Johnson & Johnson Opens Boston Innovation Centre “The East Coast's significance as a hotbed for life sciences innovation grounded in collaboration is indisputable, and continues to grow,” said Paul Stoffels, MD, Johnson & Johnson’s chief scientific officer and worldwide chairman, pharmaceuticals. Image source: EBD Group.

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JULY-AUGUST 2013 / MPN /7

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INDUSTRY NEWS | Roundup

European Chemical Regulations Update — RoHS and REACH

<< Lawyer Shapiro Jeffrey has defended the 510(k) programme. >>

Eucomed Publishes RoHS 2 Guidance Document for Electric and Electronic Medical Device Manufacturers

US Lawyer Defends 510(k) INSTITUTE OF MEDICINE’S CALL TO SCRAP REGULATION BASED ON “MISPLACED THEORETICAL CONCERN” AND “FLAWED LEGAL ANALYSIS” On May 4, 2013, Jeffrey K Shapiro, director of legal firm Hyman, Phelps & McNamara, based in Washington DC, USA, presented a draft paper and slides on the 510(k) medical device substantial equivalence programme during a conference entitled FDA in the 21st Century.

The conference was held at the Harvard Law School’s Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics.

The draft paper argues that the 510(k) programme is an excellent approach to the premarket review of medium risk medical devices, and has strengths that critics have overlooked.

The paper covers 24 pages and is divided into the following sections—introduction, 510(k) review, substantial equivalence determination, strengths of substantial equivalence review, leveraging FDA’s review experience, appropriate focus on modifications, regulatory predictability, self-sustaining management of device heterogeneity, historical developments of the 510(k) programme, the Institute of Medicine’s call to scrap 510(k), improvement needed in 510(k) transparency, and future of the 510(k) programme.

European medical device industry association Eucomed has published a guidance document which clarifies the requirements for medical device companies under RoHS 2—the Recast Directive on the Restriction of Hazardous Substances in Electrical and Electronic Equipment 2011/65/EU. RoHS stands for restriction of hazardous substances.

The paper addresses the extent of the notified body review of a manufacturer’s technical documentation according to the Medical Devices Directive when their medical device also falls within the scope of ROHS 2.

Eucomed says it is not aware of any other industry, authority or notified body position paper or guidance on the subject.

REACH Registration Stage 2 Passes Smoothly The second stage of REACH registration reached its closure deadline on May 31, 2013.

The second stage required registration of

phase-in substances manufactured and imported between 100 and 1,000 tonnes per year. The UK submitted the second highest number of registrations.

Commenting on the process, the director of chemicals policy at the UK’s Chemical Industries Association (CIA), Dr Joanne Lloyd, said: “Our member companies have worked hard to submit good quality information in time for the second registration deadline. It has not been easy, especially when the same people are also still dealing with the fall out from the first stage [2010], while at the same time looking ahead to ultimate authorisation.”

Looking ahead to the third stage in 2018, Jo pointed out concerns that SMEs may struggle to cope. She said that the CIA will be doing all it can to help those needing support and to encourage everyone to start work early to avoid supply chain disruption for both the consumer and businesses.”

3D Printed Bioresorbable Polycaprolactone Splint Implanted into Baby’s Trachea at University of Michigan Children’s Hospital After getting emergency clearance from the FDA, an associate professor of paediatric otolaryngology at the USA’s University of Michigan (UM) created and implanted a bioresorbable tracheal splint for a baby with breathing difficulties. The splint is made from polycaprolactone and was manufactured using a 3D printer. It was custom-designed to fit the baby’s trachea using dimensional data captured using a CT scan of the baby’s trachea and bronchus. This data was used to create high-resolution imagery via computer-aided design (CAD) which gave the 3D printer the necessary instructions to print the device by depositing a series of layers of powdered polymer and then melting them.

Following the procedure the baby’s breathing difficulties were reportedly solved. The event marks another FDA approved custom manufactured plastic device produced on a 3D printer. In February 2013, the FDA approved the OsteoFab Patient Specific Cranial Device, manufactured by USA-based Oxford Performance Materials (OPM), manufacturer of PEKK (polyetherketoneketone) polymer compounds, stock shapes and customised additive manufactured products.

US Price Pressure Looming?

New York Times Argues US Healthcare Costs Inflated Health Insurers’ Analysis Suggests US Colonoscopy Procedure Nearly Twice as Expensive as That in Switzerland A report in the New York Times published on June 1, 2013, argues that US healthcare costs are substantially inflated compared with other developing countries. The report is based on an analysis of the cost of healthcare procedures in developed countries contained in the2012 Comparative Price Report produced by the International Federation of Health Plans, a leading network of US health insurers.

Honing in on the cost of a colonoscopy procedure, a relatively quick and simple process,

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the report cites the average cost excluding sedation at US$1,185 compared with US$665 in Switzerland. The report also points out that the cost of the procedure varies enormously across the USA, and even within a city. Highest prices paid for a colonoscopy in metropolitan areas across the country range from the cheapest in Baltimore at US$1,908 to the most expensive in New York of US$8,577—making the price of the one in New York 350% more than that in Baltimore.

The report also points out that USA spends around 18% of its GDP on healthcare, stating this is nearly twice as much as most other developed

countries. It claims that hospitals, drug companies, device makers, physicians and other providers are able benefit by charging inflated prices, favouring the most costly treatment options and curbing competition that could give patients more, and cheaper, choices.

The report continues a theme of price pressure on the US healthcare sector, triggered by the Affordable Care Act, aka the Obamacare healthcare reform brought into US law in March 2010. Obama’s goal is to help America’s poor gain better access to the country’s healthcare services.

25-26 September 2013 NEC, BIRMINGHAM, UK

Find us in HALL 3A, STAND H12 www.mediplasuk.com

JULY-AUGUST 2013 / MPN /9

MASTERBATCH PROTECTING INTELLECTUAL PROPERTY | 8% of Global Medical Device Sales are Illegal Copies, Says WHO

COUNTERFEITING: Are your devices at risk?

by Fernando Sanchez and James Petrie of PolyOne Global Color and Additives

Rather than reacting to these disasters and incurring the resulting liabilities, some healthcare device brand owners are taking a proactive stand by investigating and implementing anticounterfeiting tools. Also known as authentication technologies, they provide a means to positively identify a device as genuine. Let’s investigate the current situation and solutions along with the true cost of counterfeit devices.

electronics and apparel to after-market automotive parts and pharmaceuticals.

Luxury goods, which many consider to be the biggest problem, represent only 4% of the total, according to the non-profit organisation International Anti-Counterfeiting Coalition.

(IACC—http://iacc.org).

How does this trend affect healthcare brand owners? The US Department of Homeland Security reported recently that counterfeit medical devices and pharmaceutical products seized last year were valued at US$83 mn.

Counterfeiters may target products such as pharmaceutical ingredients, stethoscopes, blood glucose monitors, diagnostic equipment, contact lenses, condoms, and surgical mesh.

In one high profile case, the FDA seized over a million forged diagnostic test strips (used by diabetic patients to monitor their blood glucose concentrations) with additional supplies later recalled by the genuine manufacturer when the false lot numbers were identified. These fake test strips returned inaccurate blood glucose values, so that patients using them could have taken too much or too little insulin.

Aside from the loss of revenue, brand-owner issues caused by counterfeiting, while sometimes hard to quantify, are costly and damaging. Some of these issues include: l Erosion of brand equity; l Damage to the brand owner’s reputation; l Potential liabilities; l Loss of brand integrity; and l Protection, investigation, and litigation expenses.

These hidden risks and costs can be just as damaging, if not more so, than the revenue drain that knockoffs represent. So what can you do about the problem?

Not just a luxury goods problem Make no mistake—counterfeiting is a significant and mounting problem that negatively impacts consumers, businesses and entire economies.

Several watchdog organisations estimate that this practice represents a cost of over US$1 tn to the combined economies of the world. While accurate totals are difficult to generate—because these activities take place without any enforcement or regulation—the combined economic impact estimate includes all counterfeit goods and digital piracy, from consumer

Beyond the RFID chip: international authentication methodology standard ISO 12931 Casino chip manufacturers have been using RFID chips to ensure authenticity and traceability for a number of years, but this technology is only one of many in the currently available arsenal.

In response to the growing issue of counterfeiting, the International Organization for Standards (ISO) issued ISO12931:2012 last year.

It specifies best practice performance criteria and evaluation methodology for authentication

IS IT TIME TO PROTECT YOUR BRAND? BEYOND THE PROBLEM OF FAKE PHARMACEUTICALS LIES AN EQUALLY ALARMING TREND TOWARD IMITATION MEDICAL DEVICES. BUT AN EMERGENT GROUP OF TECHNOLOGIES CAN HELP STOP COUNTERFEITERS IN THEIR TRACKS. Counterfeiting most often conjures up images of paper currency or designer goods such as purses and shoes. However, this real and growing problem increasingly affects medical device manufacturers as well.

According to the World Health Organisation (WHO), as much as 6-8% of the US$300 bn global medical device market is comprised of counterfeit goods. In this particular instance, counterfeit goods are identified as: l Remanufactured or refurbished single use devices which are introduced back into the supply stream; l Outright counterfeits or clones; and l Equipment that has been modified to accept counterfeit consumables like ink cartridges or paint.

Although most counterfeiters concentrate on low cost, high turnover, high demand products, counterfeit medical devices can be high value products. Compounding the problem is the fact that many counterfeit devices are usually packaged to a high standard and difficult to distinguish from the genuine article.

Counterfeiting in medical devices occurs at various levels of the value chain, from device components to finished products. Finished products affected by counterfeiting have included blood glucose monitoring systems, surgical sutures, catheters and heart valves. In the case of device components, counterfeiting has also been seen in cardiovascular and orthopaedic product lines.

Unfortunately, the first indication that a counterfeiter has convincingly reproduced a device often happens when the device either fails in some way or causes harm to a patient.

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<< From stethoscopes to syringes, the influx of imitation medical devices threatens to erode not only revenues, but also brand equity. Find out how to take action against these risks with authentication technologies. >>

COVER STORY

solutions used to establish product authenticity throughout the entire product life cycle. It’s intended to guide all types and sizes of organisations in determining the authentication elements they need to combat the risks of counterfeiting. These elements can be part of the device or product itself and/or its packaging.

According to the ISO, authentication is the act of establishing whether a product is genuine or fake. There are three main technology areas that comprise these solutions: l Overt: element detected by one or more of the human senses—examples include fragrances, visible tags such as holograms and laser marking, or tactile mouded features; l Covert: element hidden from human senses and made visible by the use of a tool— examples are microscopic particles (called taggants or tracers), thermo-chromic additives, RFID chips, and invisible pigments detected by infrared light; and l Forensic analysis: lab or field testing protocol that requires a device to be destroyed or rendered useless in order to verify the presence of an authentication element or intrinsic attribute; requires specialised equipment and a skilled expert.

For medical devices and pharmaceutical packaging, the proper mix of overt and/or covert technologies added as a masterbatch to the polymer components can deliver a powerful shield to protect brands and their products. For example, two or more micro-taggants can be used in combination with each other to achieve a “unique signature” level of protection.

Strategies and solutions Because of the cost and risk associated with an influx of counterfeit products, governments as well as companies are starting to develop strategies to deal with this issue, including:

l Tightening supply chain control and management; techniques including approval of customers and suppliers; l Strengthening law enforcement relationships; l Accelerating the supply chain; l Ensuring IP is used in a disciplined fashion on all products; and l Using available brand protection technologies to help identify fakes, forgeries, copies and counterfeits.

Healthcare brand owners are actively investigating this last strategy and in response PolyOne recently developed a customisable portfolio of overt, covert and forensic technologies that can be incorporated into masterbatch solutions for a number of processing techniques. A host of factors were critical to brand owner needs, including an ability to test in the field, to identify and track products in the value chain, and to defend their brand against unjustified complaints and liability/warranty claims—all while safely expanding into new geographic markets.

The combined resource and service portfolio, called Percept Authentication Technologies, includes masterbatch or compounding development tailored to the application, as well as confidential, expert assistance with technology choice, design, usage, process, product, and specification development.

These services are intended to shorten product development times and maintain quality levels while providing an added level of security to protect supply chain integrity. Masterbatches can be based on a variety of polymers: PP, PE, PC, PVC, PS, ABS, PC/ABS, Acetal (POM), PET, PBT, TPU, TPE, polyamides and other engineering thermoplastics.

PolyOne will be featuring this new technology at K 2013, the world’s largest plastics trade show, in hall 8A, stand J13. K will be held in Düsseldorf, Germany, on October 16-23, 2013.

<< Over a million ersatz blood glucose test strips were seized by US officials after a detailed investigation. The strips did not accurately display a patient’s blood glucose levels, which could have contributed to the over or under dosage of insulin. Luckily, these strips were identified and removed from the market in time to avoid health risks. >>

About the authors: Fernando Sanchez is marketing director at PolyOne Global Color and Additives. James Petrie is marketing director at PolyOne Color and Additives North America.. << Blood glucose monitors are among the medical devices that have been affected by counterfeiting. Masterbatch solutions within the polymer housing may enable healthcare consumers to positively identify genuine products easily and avoid fakes that can be potentially dangerous. >>

Leaders in the fight against medical knockoffs l 2012 US National Defense Authorization Act: Mandates anti-counterfeiting technologies be implemented by the US Department of Defense and Homeland Security and government contractors detect and avoid counterfeit parts in the military supply chain. l UL/Interpol: UL is an independent safety science company. Interpol is the International Criminal Police Organisation. Together, they conduct anti-counterfeiting courses that help law enforcement, regulatory authorities and private sector IP crime investigators to identify counterfeit cables that carry the UL mark. UL also put controls in place to reduce the opportunity for fake UL certified cables to enter the American market. (http://www.iipcic.org/FAQ.html) l GIPC: Global Intellectual Property Center is leading a worldwide effort to champion intellectual property rights as vital to creating jobs, saving lives, advancing global economic growth, and generating breakthrough solutions to global challenges. (http://www.theglobalipcenter.com) l IMPACT: International Medical Products Anti-Counterfeiting Taskforce is the working group of the World Health Organization (WHO) that identifies and removes counterfeit drugs from the global supply chain.

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MD&M EAST REVIEW US EAST COAST I Excellence in Medtech

Thought Leaders Convene Before Return of Trade Show to New York Home

by Gareth Pickering

<< Rowers on Charles River in Massachusetts with Harvard (right) and Cambridge (left) in the background. >>

Johnson & Johnson’s grand opening of its new Innovation Centre in Cambridge, Massachusetts, was met with interest by Medical Plastics News.

Accordingly, the 9,000 sq ft AS MD&M EAST (836 sq m) facility will serve as CELEBRATES ITS 30TH a “hotbed for life science innovation”. The choice of YEAR IN PHILADELPHIA, location seemed obvious— MEDICAL PLASTICS NEWS close to J&J’s head office in EXPLORES WHAT MAKES New Brunswick, New Jersey.

However, we suspect one of THE MEDTECH SECTOR the main reasons one of the ON THE NORTHERNMOST world’s largest OEMs chose PART OF THE USA’S EAST Massachusetts is the sheer strength of the USA’s east COAST SO STRONG. coast as a centre of excellence in medtech.

The northernmost part of the east coast of the USA—often affectionately known as the BosWas (Boston-Washington) Megalopolis—stretches north-south from Boston to Washington along the Atlantic seaboard. It includes major cities such as New York and Philadelphia, as well as Hartford, Springfield, Stamford and Baltimore and is a powerhouse driving the medtech industry.

Boston has one of the largest biotech clusters on the US east coast. More than 500 biotech and pharmaceutical companies are based in the area, << The cities and states mentioned in this report can be seen on this map of the USA’s east coast. >>

<< Johnson & Johnson’s new innovation centre in Cambridge, Massachusetts, nestles within the township’s pedigree universities like Harvard and University of Massachusetts at Lowell and, of course, Massachusetts Institute of Technology (MIT), one of the country’s premier medical research institutes. >> employing nearly 50,000 people and, according to some reports, almost US$2 bn has been invested there by venture capitalists in the past two years alone.

This is a huge chunk of land that harbours some fascinating statistics.

According to MassMEDIC, Massachusetts’s medical device industry association, in 2011 Massachusetts was home to 400 medical device companies, with surgical and medical instrument manufacturers leading the pack. It was also the second largest employer of people in the medical device industry behind California, employing some 24,268 within seven medical device manufacturing categories. Furthermore, the Massachusetts medical device industry was responsible for creating more than 80,000 jobs in related industries in the state. MassMEDIC quotes its source as a study by business consultancy Deloitte, The Medical Device Industry in Massachusetts. Looking further south, Pennsylvania’s medical technology industry ranks seventh in size nationwide, with US$5.49 billion in sales in 2006*. However the east coast medtech industry is really dominated by New England, Boston and the area around Boston.

As you get down to New Jersey and Delaware, you enter an area where there is a heavy concentration of pharmaceutical companies, in contrast to the medical device and biotech concentration in the north east. Much of the pharmaceutical emphasis in the mid-Atlantic region is related to the evolution of chemical companies who dominated this area a century ago. As Dan Lazas, president of US marketing agency Lazas Marketing, points out: “This is the old chemistry-based area, so companies like DuPont were set up there over a century ago. It’s when you go up into New England though, that is when you start seeing the high concentration of medical devices.”

This region, fertile with ideas and rich in medtech pedigree, saw Continued on page 15

*

TribLive—Life sciences century spurs new wave of medtech companies in Western Pennsylvania http://triblive.com/x/pittsburghtrib/business/s_672676.html#axzz2ZNsLVprJ.

JULY-AUGUST 2013 / MPN /13

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MD&M EAST REVIEW << Left: Aerial view of Boston’s Massachusetts Institute of Technology (MIT) campus and the MIT dome (below). >>

Continued from page 13 (aerospace, for example) capturing and retraining them for the plastics processing industry.

It’s a point echoed by Rubin Shah, managing director of medical balloon innovator and film extrusion specialist Polyzen in North Carolina: “The universities have such a strong education presence, not only in plastics engineering but in biomedical engineering as well. And it’s this convergence of the talent pool and the demand for that [plastics processing] specialism.”

Along with the universities, the region also boasts some of the world’s great hospitals. As Steve Wilcox, principal at Philadelphia-based medical device design consultancy Design Science, points out: “Many of the world’s great hospitals are in the northeast, so it’s an important area for medical device companies to do research.”

He adds: “Also, several key consultants in the medical device space are The east coast knowledge base on the East Coast—Ximedica in Rhode Island; Farm, Wiklund Research and The knowledge base and the manufacturers really knit together on the east Design in Massachusetts; RTEmd medical device software in Pittsford, New coast. Indeed according to Lazas, “many of the clinicians often become the York; Med-Errs failure mode and effect analysts in Horsham in Pennsylvania; manufacturer”, bringing new devices to the market. Devices are borne out of HS Design in New Jersey; and our firm, Design Science, to name a few.” their inventors’ direct experiences in cardio-surgical theatre.

It’s not just about having the brains; there is a real commercial Take a look at the list of world-leading Institutions in this region— engagement between the universities and the manufacturers in the area.

Princeton (New Jersey), Harvard (Cambridge, Massachusetts), Yale The universities “get” how to bring ideas to market. Working closely with the (Connecticut, between New York and Boston), Massachusetts Institute of manufacturers the universities provide the framework for what Dave Shalaby, Technology (MIT), University of Massachusetts (UMass) at Lowell president at custom bioabsorbable polymer developer and manufacturer (Cambridge) and Amherst, Boston University, University of Rhode Island, Poly-Med, described as “realisation—the entire process of designing, University of Connecticut (Uconn) Health Center—the list goes on. developing and bringing a medical device to market.”

It tells you something of what you need to know about this region. The Dave goes on to say: “Every university has expertise in realisation—from grey matter is here. It was these institutions from where many of the firsts for patenting, to IP management, development and all the way through to medtech sprang. In the 1970s, the University of Massachusetts at Lowell royalty and revenue protection. The major universities all have skills.” developed a plastics engineering programme that would look at the Peter Gabriele, vice president of emerging technology at medical processing of plastics for medical technology. It was a new way of looking technology developer and manufacturer Secant Medical, illustrates the point at things. perfectly: “It’s easy to stand back and look at the region as a hotbed of According to Larry Acquarulo, president and CEO of US medical academic and medical centres. This area really puts the fingerprint on polymer supplier Foster Corporation, in the 70s and 80s three academic biomedical technology.” Gabriele talks of how the region is pioneering the centres—MIT, UMass at Amherst and UMass at Lowell—all offered courses concept of translational science. “As time goes on, you will in polymer science and engineering. Larry recalls that begin to see the government encourage the concept of UMass at Lowell was the first to offer a full plastics translational science. This region is very well equipped to engineering programme. “Many plastics courses were support science and quickly turn it into a commercial activity.” teaching how to make polymers, few were offering to teach Gabriele talks of manufacturers (including Secant how to “process” plastics,” he says. “Indeed,” Larry goes on, Medical) “walking the corridors” of the universities, so close are “UMass Lowell was one of the first institutions to offer the relationships between industry and academia. Indeed, specific polymer processing courses. It also went on to offer Secant Medical currently works alongside several institutions one of the first PhDs in this in the late 80s. This plastic such as the McGowan Institute for Regenerative Medicine at processing technology was important in the early the University of Pittsburgh in Pennsylvania, and Johns Hopkins development of angioplasty catheters, balloons and other University School of Medicine (Baltimore, Maryland). minimally invasive vascular devices.”

According to Gabriele, Johns Hopkins is one of the most highly It was UMass at Lowell which was one of the first to set regarded medical research and biotechnology organisations in up advanced manufacturing centres at junior and the world, and enjoys some of the highest levels of research community colleges. The state has funded programmes for funding. advanced manufacturing, allowing 18-20 year olds to train. << Larry Acquarulo is Secant Medical, perfectly located in Perkasie, As Larry says: “These will be the technicians that will set up president and CEO of US your equipment and run your machines.” Cleverly, these medical polymer supplier Pennsylvania, in the heart of this east coast medical cluster, is currently developing early stage polymeric bioabsorbable centres are capturing the fallout from experienced Foster Corporation. >> elastomers for use in regenerative medicine. Uses could engineers in other sectors where the global slowdown has left companies with no option but to let talent go Continued on page 16 innovations such as the Foley Catheter developed in Boston back in the 1930s. The region’s universities were one of the first to offer specific plastic processing courses and the first medtech organisations evolved here.

The Massachusetts Biotechnology Council, MassBio, located in Cambridge, is the nation’s oldest biotechnology trade association, having been founded in 1985.

The reasons for the strength of this region are manifest. What’s really at the heart of why this region works so well is a symbiotic relationship between its world-leading universities (see next section), hospitals, clinicians, manufacturers and the industry bodies. All these groups come together with coherence and purpose.

JULY-AUGUST 2013 / MPN /15

MD&M EAST REVIEW Continued from page 15 include coating technology and fibre technology for large surface area bioabsorbable applications.

The manufacturers So, the seed bed for a thriving manufacturing community is there— excellence in technical design, research and academia with clear strength in commercialising engineering ideas. The next element is the manufacturers themselves.

The east coast boasts an impressive blend of small, medium and large medtech companies. The region does not simply rely on the big players.

Many of these smaller companies are run by the very alumni from the courses already mentioned. The east coast is home to all the majors. As Dave Shalaby says: “All the major companies are based in New Jersey and Massachusetts, we have J&J, Medtronic, Covidien, Pfizer (New York).”

Observers say that it’s small to medium size companies that are targeting neglected diseases.

device stakeholders in and around the state. A fourth, Massachusetts Medical Society, is one of the oldest continuously operating state medical societies in the USA. Hailing from New England, the society’s first chapters were founded in the north east. It’s a state-wide professional association for physicians and medical students. Beacon, which stands for Biomedical Engineering Alliance and Consortium, ties together hospitals, universities and advanced manufacturers with the specific aim of getting clinicians and inventors matched up. Finally the Massachusetts Biotechnology Council (MassBio), a not-for-profit organisation that represents and provides services and support for the Massachusetts biotechnology industry, is the nation’s oldest biotechnology trade association (founded in 1985). All these organisations underpin the sector and demonstrate just how much willingness there is for co-operation.

Grey matter is one thing; however cash is always king and these organisations also bring in financial resources by bringing investors in to the sector and championing venture capital models in medtech.

The state-financed Pittsburgh Life Sciences Greenhouse (PLSG), a nationally recognised investment firm, has worked with, or helped to fund, 300 fledgling companies in its eight-year history. When ideas, enthusiasm and industry meet capital, good things happen.

Industry associations Binding the universities, hospitals, clinicians and manufacturers together is the plethora of industry associations, membership bodies and organisations which all work together advising and lobbying, as well as bringing together investors with clinicians, universities and manufacturers. UMass at Lowell Governments recently launched its incubator, M2D2, which focuses on medical device At the macro level the east coast also enjoys close political contacts. The east development. This incubator launches medical device companies directly coast is one of the largest tax contributor to the US economy, and, as Rubin from the university. M2D2 has been a critical influence on many people.

Shah, says “We have Washington.” Having the nation’s capital within close In addition to this there are other significant hands-on, proactive and proximity makes lobbying easier. The medtech industry enjoys wide support well-run organisations and industry bodies. The Society of Plastic Engineers in the east coast and Governors Deval Patrick of Massachusetts and Dannel (SPE), with around 20,000 members around the world, has its home in Malloy of Kentucky are supportive of advanced manufacturing and medical Connecticut on the east coast. Much of the SPE’s early growth was along the device provided incentives. east coast. Len Czuba, SPE president in 2005-06, threeSteve Wilcox goes on to echo this: “Of course, the times chairman of that organisation’s Medical Plastics capital is here, so we have a number of key organisations near Division and owner of medical device consultancy firm Washington, DC—the FDA, the AAMI (Association for the Czuba Enterprises adds: “the New England region also Advancement of Medical Instrumentation), and AdvaMed, for represents some of the highest density of SPE membership example.” directly behind the Detroit, Michigan and Ohio auto Peter Gabriele from Secant Medical makes the point regions. SPE’s ANTEC (their flagship technical conference) that the east coast has the advantage of close proximity to the has repeatedly found that Boston is the most appealing host FDA’s headquarters (Silver Spring in Maryland). Sometimes venue, drawing record attendance both in speakers, perceived as the unwelcome state trooper of the medtech students, exhibitors and attendees.” sector, the FDA is more than an arm of the federal government, Of all the industry associations two bodies are Gabriele argues. He points out the FDA is “really working hard particularly prominent—AdvaMed, representing the length to improve the landscape” and is an important resource for and breadth of the USA’s medical device manufacturing knowledge and information. “Try entering a search term into industry, and MDMA, the Medical Device Manufacturers the FDA website—you’ll be pleasantly surprised with the Association, mainly representing small to mid-sized medical volume of information available free of charge.” He continues: << Len Czuba was device makers. As Steve Wilcox points out “AdvaMed is “Over the past ten years the FDA has played a more visible and president of the SPE in probably the most important [of the organisations]. They active role [in medtech].” are advocates, lobbyists, and disseminators of information.” 2005-06 and has been chairman of that Other notable bodies include The South Eastern Conclusion organisation’s Medical Medical Device Association. SEMDA is a clear example of The east coast model provides a blue print for co-operation Plastics Division three how the government and universities and manufacturers between manufacturers, universities, clinicians, government and times. >> have knitted together. supporting industry associations. Looking ahead and with the Three Massachusetts-based bodies—MassMEDIC, return of MD&M East to New York’s Javits exhibition centre next Beacon and MassBio—play prominent roles in integrating the medical year, the medtech industry looks confident, strong and robust.

The landscape may well look a little different as the major players’ appetite grows for perusing M&A deals. According to Kevin Bottomley, managing director of UK-based Results Healthcare corporate finance, there will be a significant increase in M&A activity over the next 12 months.

The Javits centre will see MD&M East return next year, it will be a stronger leaner, more confident medtech sector and the stakeholders of the east coast region will have played a critical role in delivering this.

Medical Plastics News would like to thank the following thought leaders for their help in preparing this article: Larry Acquarulo, Len Czuba, Peter Gabriele, Ryan Heniford, Dan Lazas, Rubin Shah, Dave Shalaby and Steve Wilcox. << A vintage engraving of Harvard university campus during the 1890s (source: Trousset encyclopedia 1886 – 1891). >> 16/ MPN / JULY-AUGUST 2013

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Injection Moulding | BIOABSORBABLE IMPLANTS

Injection Moulding Fundamentals for Small Complex Bioabsorbable Implants

By Tanner Hargens, regional vice president at US contract development and manufacturing firm Medical Murray.

Bioabsorbables are widely utilised for cardiovascular applications. Examples include ligation and closure of blood vessels along with absorbable drug releasing stents and grafts. Many of these devices have small, complex, 3D structures and dynamic mechanical requirements that can only be formed by the injection moulding process.

Injection Moulding Bioabsorbable Polymers Injection moulding first transitions a polymer from a solid state to a semi-liquid state by heating the material above a threshold temperature. With a reduced viscosity upon turning into a liquid, the polymer can be forced or injected in to the cavity of the mould. The process must then be reversed and the material must return to a solid state before it can be removed from the mould.

Moulding bioabsorbable polymers with tiny features and thin sections is a delicate process.

“Temperature control is a critical factor,” says Norman Akens, moulding manager at Medical Murray. “If the material is exposed to elevated temperatures, this can result in monomer formation and alter mechanical properties.”

Changing mechanical properties can alter degradation kinetics, which can result in toxic material.

<< Bioabsorbable implant with snap feature and six living hinges (part diameter: 14mm). >> Due to both the extremely sensitive nature and hefty cost of bioabsorbable polymers (up to 18/ MPN / JULY-AUGUST 2013

US$13,000 per kg), it is essential to have dedicated processes and equipment in place that is developed specifically for small complex bioabsorbable parts.

The Sesame moulding machine, designed and patented by Medical Murray and manufactured by specialist medical machinery supplier Lawson Medical Group (LMG), based in Wisconsin, USA, provides fast controlled injection and short material residence time. The US patent number of the Sesame is 6,267,580. It uses a pneumatically driven vertical plunger for plasticating, and injects the material with a tiny horizontal plunger (1.0-2.5 mm diameter) driven by a linear servo motor. Total injection time can be as short as 0.02 seconds.

Low melted volume, controlled high speed, and high pressure injection allows for the moulding of tiny size parts with complex geometric features. Higher injection speeds ensure the material will fill the part before it cools.

Medical Murray has been instrumental in creating miniature hinges for implantable bioabsorbable fasteners. The Sesame machine has been used to produce parts that measure just 0.10 mm and weigh only 2.5 mg, or 1/25th of a single pellet.

Conclusion The use of bioabsorbable materials in modern medicine has had a dramatic impact on the device design and development field throughout the past decade. Whether they are used to facilitate a controlled drug delivery function for stents and grafts, or engineered for wound closure, the possibilities are vast.

When using bioabsorbable materials in a new project it is important to consider using a dedicated engineering team that fully understands the temperamental nature of this material and the hefty cost parameters. A careful combination of the correct mould design, proper machining processes, and consistent material from start to finish will ensure continuous design success.

About the author: Hargens specialises in implants, biomaterials, and minimally invasive procedures and provides expertise related to commercialising medical products including patent protection and regulatory strategising.

<< This dogbone is an example of a device moulded from one of PolyMed’s polymers. >> Profile of Osteoprene and Maxprene Bioabsorbable Polymers, by Dr Brad Winn, PolyMed The expected time taken for bioabsorbable polymers to degrade and subsequently be eliminated from the body via normal metabolic pathways can be modulated through various polymer design criteria, such as composition, molecular structuring, and secondary processing.

PolyMed’s Osteoprene and Maxprene family of polymers are a series of copolymers comprising lactide, glycolide, caprolactone and trimethylene carbonate—monomers commonly used to manufacture medical devices. These have been processed into a number of different constructs including moulded articles, monofilaments and multifilaments. These polymers have also been custom designed in an array of molar compositions and molecular weights to be used for injection moulding and other secondary processing applications. Compositions have been designed to exhibit varying stiffness and toughness depending on the desired application while maintaining strength in vitro for 1-6 months, depending on formulation with complete mass loss within approximately 3-24 months.

Melt flow index values for Osteoprene and Maxprene polymers range from approximately 8 to upwards of 25 (g/10 min at 230°C, 2,160 g weight) depending on formulation according to desired specifications. Previous experience with injection moulding of Osteoprene and Maxprene polymers has shown ready ability to mould parts with an aspect ratio upwards of 200 without the addition of surfactants. Furthermore, parts injection moulded using these polymers can be generated having stiffness values ranging from approximately 260-1,600 MPa demonstrating the versatility of these polymer families.

The ability of these polymers to be used for injection moulding applications combined with their high strength allows for streamlined, cost-effective manufacturing of devices having complex and relatively intricate geometries. These polymers can be especially useful where tailored strength and rigidity are of utmost importance such as bone plugs or screws, sutures, staples, and other fixation devices.

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Processing and Equipment Self Contained Class 8 Moulding Installation and Noise Reduction Work Injection moulding machine maker Sumitomo (SHI) Demag has two pieces of recent news related to the medical sector. First, it has installed self contained class 8 cleanroom moulding machines at Carclo Technical Plastics in the Czech Republic. Second, it has written about noise in injection moulding and how its machinery can contribute to reducing it.

Sumitomo Demag was formed in 2008 as a result of the merger of Germany’s injection moulding machine manufacturer Demag Plastics Group and the injection moulding division of Japanese heavy industries major Sumitomo Heavy Industries (SHI). The article about noise reduction is as follows. << Self contained class 8 cleanroom production units have made Carclo’s investment economic. >>

Following numerous customer requests for medical devices made to class 8 standards, Carclo Technical Plastics’s operation in Brno in the Czech Republic looked to integrate an onsite cleanroom at their 4,730 m2 facility, yet it seemed to be cost exorbitant to build a facility.

When the operation discussed the dilemma with Sumitomo (SHI) Demag, the proposal of a self-contained activeCell cleanroom moulding and packing system, was described as a “eureka” moment for Carclo Technical Plastics’s technical director Lee Dodd.

Sumitomo (SHI) Demag had a number of bespoke challenges to overcome: the cell’s seal would be broken by cranes and other equipment regularly entering the machine, yet the system had to retain class 8 standards; the product portfolio was extensive requiring large and small parts of all geometries to be manufactured and then either bagged or boxed; the facility to track and trace bagged products was needed; and identical machines were required with inter-transferable mould and robot programmes.

The all-electric compact mini cleanroom system designed and installed by Sumitomo (SHI) Demag was fitted with laminar airflow cabinets for particle-free air in the mould-space area, integral packaging equipment and a six-axis Yaskawa Motoman robot which removed parts from the mould ready for packing.

Noise: Sumitomo (SHI) Demag has written information outlining how its injection moulding machines can contribute towards noise reduction on the factory floor.

According to the company, a sound pressure level of as much as 65 dB (A) can potentially cause concentration disorder and negative effects on the cardiovascular system.

The company states that hydraulic machines from Sumitomo Demag generate less noise when an activeDrive drive concept is used. It reduces the sound pressure level of Systec 210 (2,100 kN closing force, 560 mm bar width) to 60 dB (A).

The activeDrive drive concept consists of a frequency-controlled high-performance motor and a hydraulic pump. Dynamic power adjustment to all cycle-dependent requirements ensures optimal efficiency because there is only as much power as required in each cycle sequence. This results in significant energy savings of 30-60% and a noticeable, about half as high, noise level.

<< The production units shown here producing contact lens cases are fitted with laminar airflow cabinets for particle-free air in the mould space area. >> 20/ MPN / JULY-AUGUST 2013

Carclo Invests in USA Carclo Technical Plastics has announced plans for significant expansion at its manufacturing facility

in Latrobe, Pennsylvania, in the USA. The move follows major investments at the company’s plants in the UK and the Czech Republic revealed in December 2012.

Carclo Technical Plastics is the largest division within Carclo plc, a UK-based manufacturer of plastic products. The company focuses on technical mouldings, and has a strong foothold in assembled and packaged finished devices for the medical, pharmaceutical, diagnostic and ophthalmic sectors. Typical products include drug delivery devices and diagnostic consumables. Global sales of Carclo Technical Plastics were £57.1 mn in 2012/13 with Carlco plc turning over £86.5 mn.

At Latrobe, the company will invest a total of US$5.8 mn in expanding the facility, adding 28,000 sq ft (2,601 sq m) of ground floor manufacturing space. In addition, there will be a second floor, covering approximately 1,500 sq ft, to house additional engineering and support functions.

The company expects to acquire an additional total of 30 moulding machines and auxiliary equipment to fill the new space, the cost of which are not included in the US$5.8 mn investment figure.

The expansion will include a class 8 cleanroom covering a total area of 9,000 sq ft which will house ten of the 30 new moulding machines. Carclo say the expansion will also allow the increase in class 8 cleanroom areas as business needs require.

Speaking to Medical Plastics News about the investment, Rob Stutzman, Carclo’s director of global sales and marketing, said: “We are designing the build in a manner that will allow us to expand the cleanroom area within the 28,000 sq ft expansion. We haven’t bought all 30 machines yet but will add them as needed, specifying them around the customer requirement on a project by project basis.”

The additional 30 machines will represent a 50% increase on the number of existing machines in Carclo’s US manufacturing portfolio. Rob explained: “Putting this into context with our US manufacturing operations, currently we have 61 moulding machines so the additional 30 will represent a 50% increase in capacity. Specific to Latrobe we will more than double our manufacturing area as currently Latrobe has 24 machines.”

Carclo have stated that the main reason behind the expansion is significant new customer acquisition in the diagnostics and drug delivery markets so far in 2013. Growth in the company’s optics business is also an important factor.

Rob added: “Both our medical and optics

businesses are experiencing double digit growth, with medical being the largest. It is an exciting time for us as this is the largest expansion within Carclo Technical Plastics since our move to our Czech facility. We made some difficult decisions back in 2005-06 that have ultimately put us in the position to grow in the areas that are more profitable and stable for our employees and shareholders. Based on our activity level I expect we will fill this capacity in short order.”

Carclo Technical Plastics has manufacturing operations in the UK, east and west USA, the Czech Republic, India and China.

Credit: The editor was alerted to this expansion after reading an article on PlasticsNews.com.

Fipa Offers Varioflex Part Removal Vacuum Suction Cups for Grained and Curved Surfaces German manufacturer of end of arm tooling Fipa is offering customers a new suction cup, the Varioflex. According to the company, the new products are already being used by automotive plastics supplier Tanne Kunststofftechnik.

Fipa says Varioflex suction cups offer good process reliability, something not previously being achieved by Tanne. The company’s previous suction cups did not develop the

necessary suction force when removing parts from the mould undercut. Grained surfaces caused micro-leakage and significantly reduced the suction force of standard suction cups.

Vacuum cups were sought which could reliably grip grained and sometimes curved parts without loss of suction.

Varioflex suction cups offer a soft sealing lip (30° Shore) which sits seamlessly onto << Fipa’s new Varioflex vacuum suction cups for part removal reportedly work well with grained and curved surfaces by gripping without loss of suction. >>

dimensionally stable bellows (60° Shore), which prevent lateral bending within wide limits. The sealing lip reportedly offers strong holding force, even on uneven surfaces—a benefit that is particularly useful for grained surfaces. The bellows balance out height differences in components. The dimensionally stable body offers outstanding reset force and enables fast cycle times.

Sales of Injection Moulding Machines Grow Modestly in Germany The German injection moulding market is demonstrating modest growth despite a fragile European economy, according to the latest edition of AMI’s Guide to the Injection Moulding Industry in Germany. AMI is Applied Market Information, a UK research group with a focus on the plastics industry.

The edition, revised from 2009, contains extensive details on over 2,250 injection moulding operations in Germany that were gathered by direct contact with each company to ensure the highest possible level of accuracy.

JULY-AUGUST 2013 / MPN /21

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Mould Design and Manufacture: REVIEW Better Undercut Release for Luer Fittings Al Hickok from Roehr Tool Corporation and Glenn Starkey of Progressive Components have produced a case study which examines the benefits of expandable cavities for moulding luer fittings. Roehr Tool and Progressive Components are sister companies which engineer and distribte mould components around the world.

The writers argue that by using expandable cavities, mould builders can enjoy—fewer moving parts, reduced design time, having cooling lines concentric with the part, using a smaller mould base, and grease-free operations.

Extracts of the case study are as follows.

A typical luer fitting is used by the medical industry to make secure, leak-proof connections with tubing in medical devices. Many of these fittings have external undercuts, which makes the mould more costly and complicated and increases the risk for quality defects in production. More cost effective and simpler solutions are always of interest when working with medical OEMs. Small undercut details have traditionally been formed from large side actions on two to four faces of the part, resulting in the need to build a much larger size mould than if the undercuts were not present. In addition, side actions carry with them costs for construction, and they introduce their own risks and considerations for maintenance over the life of the tooling programme.

However, practices are evolving and tooling engineers now recognise the advantages of utilising a single, expanding cavity component as an alternative to the usual “slide mould” designs.

Often referred to as “ex-cavs”, expandable cavities are constructed in an expanded position, meaning that during moulding they are pulled << Four-cavity hot runner luer fitting mould using ExCavs instead of slides.>>

22/ MPN / JULY-AUGUST 2013

<< Expandable cavities allow for very tight cavity spacing compared to slides, allowing for more cavities per mould or a smaller mould and press. >>

back against a striker ring and collapsed inward.

For ejection, the component is staged forward, which allows the segments of the Ex-Cav to expand outward. This releases the undercut and the part is then ready for ejection. They are commonly staged forward during mould open to enable the fastest possible cycle time.

One mould builder in New York recommended the use of Ex-Cavs for a project and then verified the simplicity and cost savings, saying: “It was much simpler to machine features into the mould core insert and the pin plates to accommodate the expandable cavities versus having to spend significantly more time and costs doing all the tool work required for slide sets. We were able to eliminate the slides and also the related components.”

Expandable cavities have been proven to improve cycle times, as a Massachusetts-based mould builder related that fewer moving parts added up to more efficient cooling and therefore lower cycle times and more manufactured parts. Easier maintenance was also reported to be a benefit of a simplified tool design.

Moulding Cycle Monitor in New Languages, Alignment Lock Tested to 2 mn Cycles AST Technology, another sister company, is promoting that its cycle monitor system, CVe, is available in six new languages— French, Italian, Japanese, Korean, Portuguese and Thai. The new languages complement the existing range of English, German, Mandarin and Spanish. The product helps to produce comprehensive mould performance reports by monitoring and collecting information like cycle counts and maintenance actions.

Progressive Components has reported that its new Z series of alignment locks have been independently tested to show no wear after 2 mn cycles. They are now Progressive’s standard alignment locks.

New Release of Moldex3D Predicts Effectiveness of Core Shift in MultiComponent Insert Moulding Processes Simpatec, a European distributor of injection moulding simulation software Moldex3D, has written about how the software can help product designers and mould builders with insert moulded multi-component metal and plastic parts.

During insert moulding, it is often difficult for engineers to observe the deformation of part inserts without any analytical tools. Moldex3D advanced forecast techniques are said to find out the stress and displacement distributions of part inserts in the filling process through coupling calculation of the insert parts and melt flow.

Furthermore, designs can be optimised via visualising the part inserts displacement results.

The new release R12 Moldex3D Advanced reportedly provides a two-way FSI (fluidstructure coupling) algorithm technical application. The feature simulates entire dynamic flow interactions with core deflection and mesh deformation. It examines the change of core under the influence of fluid to optimise injection pressure. The behaviour of the products and part inserts are displayed synchronised with the melting flow. The result is able to accurately show the part insert deformation in every filling percentage of the cavity. Furthermore, a number

of features support the part designer to avoid core deformation. These include the prediction of thermal degradation caused by hot melt flow reheating, temperature variation of the part insert during the moulding process, and results like the flow pressure, stress distribution and displacement around the part insert or the final part shape.

“Moldex3D provides the latest multicomponent and insert injection moulding prediction technologies,” stated Cristoph Hinse, managing director of SimpaTec, Moldex’s exclusive reseller in German-speaking countries.

“A part designer can predict the effectiveness of the core shift by fluid-structure coupling analysis.

This method assists them to control product quality more precisely and to predict potential moulding problems before mould manufacturing.

Twin Shot Tamper Evident Luer Lock Closure German mould maker Braunform has written about a recent project to build a mould for the manufacture of two-component, or twin-shot, tamper evident luer lock closures (TELC) for German pharmaceutical packaging company Gerresheimer Bünde, formerly Bünder Glas. The mould is for use in a class 5 cleanroom, among the most stringent used in the medical plastics industry.

A technical innovation of the mould, according to the press release, is “the nozzle side, low particle unscrewing of the luer lock adapter, as well as low-particle shearing off of the sprue after the injection process”.

The release goes on to say: “very skinny, freestanding cores go into action due to the filigree contour for the originality tabs, which display the first-time opening of the closure”. It adds: “There’s also implemented a special needle seal hot runner system for the cap, which is operated by an inclined ramp.

Other technical challenges are the cap’s thick walls, which must be openable with a defined torque, as well as the clean contour separation of the two components.

The mould manages a large temperature gradient with polycarbonate at a mould temperature of about 100°C and a TPE at 40°C (see image overleaf ).

Besides the temperature difference and the high pressure, the challenge lies in processing in the hard/soft combination, which does not chemically bond to itself and furthermore is sterilisable. To avoid burning and black spots in the polycarbonate components, the manufacturer’s instructions must be strictly followed.

Due to the critical material selection, the TELC is injected in an own production cell and

Continued on page 25

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K 2013, hall 15, stand B27/C24/C27/D24

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JULY-AUGUST 2013 / MPN /23

Additive Manufacturing 3D Printing Prototyping Product Development Software Scanning Digitising

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25-26 September 2013 NEC, BIRMINGHAM, UK

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CLEAN MACHINES

SPONSORED BY Continued from page 23 each cavity is intercepted individually by a Braunform patented handling system. Afterwards, customer-specific rubber seals are inserted during the assembly process.

Toolcraft Installs €1.5 mn Automated Machining Centre At the start of 2013 the tool making division at German specialist moulder of small plastic parts, including ones for the medical sector, Toolcraft put a new automated machining centre into operation. The centre features automated management of all tool parts and electrodes in a UPC pallet system based on Certa automation software.

The fully air conditioned centre is equipped with the following machinery: an Exeron HSC 600 5-axis milling machine with Awex 50/5 alternator, an Exeron HSC 300 3-axis milling machine with Awex 50/5 alternator and an Exeron EDM 313 electric discharge machine with Awex 50/5 alternator, two Exeron EDM 312 electric discharge machines with Erowa ERM robots and an Exeron EDM 310 electric discharge machine.

Two Zeiss Contura 3D coordinate measuring machines are also used in the measuring department, which obtain measured data directly from the design department. Pallet cleaning is carried out by an Erowa robot system.

With the new centre, Toolcraft can produce moulds around the clock when needed, with high throughput and fast delivery times. The new system means that not only can a timely flow of parts be achieved, but tool design can also be included in production: tool designers can send measuring points and tolerances directly to the Zeiss measuring equipment. Linking design and production results in continuous quality monitoring. A high technical level with high flow rates and a significant reduction of manual work is achieved with this kind of industrialised tool making.

<< This Braunform two component (twin shot) mould manages a temperature gradient between a polycarbonate shot of 100°C and that of a TPE at 40°C. >> The mould making and injection moulding division at Toolcraft has its roots in model railway making. At the time, miniatures in this field already set high standards in attention to detail and manufacturing knowledge. After this industry ‘migrated’ out of Germany, Toolcraft turned to hearing aid manufacturers to supply them with complete assemblies. All major manufacturers in Europe, America and Asia are now customers.

Standards in this sector are very high, says Klaus Dörr: “The tiny components make very high demands on tool making, but also on production and assembly. The required clearances and accuracy of fit of the parts are at a level which is much easier to achieve in other industries.” Small parts for hearing aids range from a 0.01-5 g charge weight. In order to be able to offer complete solutions as part of their precision strategy, Toolcraft has a small parts department with 20 injection moulding machines and 30 staff in addition to their mould making department

with a total of 18 machines and 70 staff.

Furthermore, machines for running-in and series start are available separately.

Hearing aid requirements are many and varied: in addition to the high precision required for these miniatures, accuracy of fit is also highly prized. Customers require small clearances from, 10-20 μm, a value which is nowhere near as low in many other industries. In terms of injection technology, warping is a particular issue. In order to keep this as low as possible, Toolcraft relies on conformal cooling in tools: on this front, conformal cooling provides ‘easing’ at relevant points on the tool. “A very effective method”, says Klaus Dörr, “in which the strengths of classic tool making production and the generative production of laser melting with metals provide combined solutions, making for impressive production technology. It’s also clear that parts like these demand precision rather than the lowest possible cycle speeds.”

<< CAD image of a hearing aid injection mould from Toolcraft. >>

JULY-AUGUST 2013 / MPN /25

MATERIAL DIAGNOSIS ENGINEERING POLYMERS | New Grades, Additives and Applications

Adversity in Gamma Irradiation on PMMA IOLs, High Flow PMMA and Clear Polyamide, Cyclic Olefin Copolymer in Insulin Monitor, New Polycarbonate and PC/ABS Blends and Non-toxic Anti-hydrolysis Agent Monitoring Adverse Effects of Gamma Ray Sterilisation on PMMA for Intraocular Lenses A team of UK researchers has provided an update on a piece of analysis to gauge the adverse effects of gamma radiation sterilisation on the performance of intraocular PMMA lenses, particularly with respect to polymer chain and bond cleavage. The article is an update of a report covering the same topic published in Medical Plastics News, September-October 2011, issue 2. The team of researchers consists of academics from Kingston University—Dr Stephen Barton, Professor Peter Foot, Dr Philip Miller Tate, Dr Mariko Kishi, Dr Baljit Ghatora—and Dr Bassem Sabagh of UK-based manufacturer of analytical equipment Malvern Instruments (for image see page 28). The report is as follows.

Gamma irradiation is widely considered the most cost-effective sterilisation method for many medical grade materials. However, for polymers the potential for chain and bond cleavage raises significant concerns over long term performance and safety. This article presents a brief overview of further work from researchers at Kingston University.

It is estimated that around 90% of the world’s visually impaired individuals reside in developing countries. For many, cataract replacement surgery using synthetic polymer intraocular lenses (IOLs) provides a relatively straightforward surgical solution, with PMMA lenses a cost effective choice. Sterilisation of an IOL by gamma irradiation reduces the potential for infection but can have an adverse impact on the polymer structure as the following studies show.

1

Measuring the Impact of Irradiation: Experimental work was carried out to determine the effects of gamma irradiation on the characteristics of PMMA IOLs. The new research extends earlier studies using gel permeation chromatography/size exclusion chromatography (GPC/SEC) [as published in Medical Plastics News, see earlier] to study polymer degradation with additional investigations into the potential impact of observed structural changes.

Chromatography is a collective term for a group of lab techniques used to separate a mixture. Size exclusion chromatography (SEC) is a separation method in which molecules in solution are separated by their size, and in some cases molecular weight. Gel permeation chromatography (GPC) is a type of size exclusion chromatography (SEC), used commonly with 26/ MPN / JULY-AUGUST 2013

<< Figure 1: Triple detection chromatograms of the samples: a) for the ultra-high molecular weight PMMA sample and b) for the gamma sterilised ultra-high molecular weight PMMA sample. The irradiated polymer displays a significantly greater retention volume. >> polymers that have been dissolved in an organic solvent.

Immersing gamma irradiated PMMA discs in simulated aqueous humour solution (SAHS) and then periodically removing them for gravimetric and thermochemical analysis has provided new insights into the impact of sterilisation on lens performance.

GPC/SEC analysis was performed with a Viscotek TDAmax GPC/SEC system (manufactured by Malvern Instruments) to compare the physical properties of pure, unexposed PMMA with those of an irradiated sample. The sterilised PMMA eluted later than the control, suggesting a smaller hydrodynamic radius. Light scattering analysis supported this observation, showing a significant drop in molecular weight from 3 million to 142,000 Da, suggestive of chain scission.

This conclusion is supported by an associated increase in polydispersity, from 1.731.78 for the control to 2.23-2.28 for the irradiated sample. Dispersity is a measure of the variance in molecular weight of the polymer chains in a polymer sample compared with the mean molecular weight of each chain—a

polydisperse sample contains polymer molecules of inconsistent size (or chain length), and molecular weight.

Gravimetric studies revealed a slight increase in the rate of diffusion of the SAHS into the irradiated PMMA polymer, compared with the control, and a 1% increase in the material’s volume. Thermochemical analysis of the irradiated PMMA sample indicated a decreased glass transition temperature, Tg, and a notable increase in plasticity, a change that would tend to be associated with deteriorating optical performance.

In combination, these results suggest that changes in the PMMA stemming from chain scission induced by sterilisation with gamma irradiation are likely to reduce IOL performance.

Such findings caution against the use of this sterilisation procedure. However such conclusions need to be carefully weighed against the benefits of affordable surgery.

Reference: [1] Ghatora, B et al (2013) The Effects of Gamma Irradiation on Medical Grade Poly(Methyl Methacrylate) Polymers & Polymer Composites, Vol 21, No1, 1-7.

Continued on page 28

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Engineering Passion

MATERIAL DIAGNOSIS Continued from page 26

<< (Left to right) Dr Baljit Ghatora (lecturer in forensic and analytical chemistry), Prof Peter Foot (professor in materials chemistry), Dr Stephen Barton (principal lecturer in analytical chemistry), Kingston University. >> Arkema Develops High Flow Luctor PMMA Alloy and Clear Rilsan Polyamide Altuglas International, a subsidiary of French chemical manufacturer Arkema, has introduced Altuglas Luctor polymethyl methacrylate (PMMA) alloy for medical processors. The alloy is described as being a high flow polymer and is said to flow “twice far as conventional transparent medical polymers” in thin wall injection mould cavities.

With this new material, devices such as intravenous (IV) line components can be moulded with thinner wall sections, using multicavity moulds to reduce material and processing costs.

“Altuglas Luctor PMMA alloy was primarily designed to improve product and processing costs for PMMA components,” said Kirsten Makel, business director at Altuglas International.

“However, the IPA [isopropanol alcohol] resistance of this alloy makes it more than a high flow acrylic.” Isopropanol alcohol is a common chemical used to clean medical devices.

Processors who are looking to reduce cost through efficient use of materials in thin wall parts are expected to benefit most from this alloy, especially as healthcare cost management initiatives and competition among device companies are placing greater demand on medical component manufacturers to reduce costs.

Material costs can be reduced by designing components with thinner wall sections.

Processing costs can be reduced by decreasing sprue and runner sizes and increasing the number of cavities in multi-cavity moulds.

Altuglas says that these savings can only be achieved with materials that offer substantial improvements in melt flow. The new alloy from Altuglas is a chemical resistant, transparent polymer that is said to offer a step-wise improvement in flow over traditional transparent polymers, such as PMMA and polycarbonate.

The superior chemical resistance properties of 28/ MPN / JULY-AUGUST 2013

Altuglas Luctor PMMA alloy allow it to replace polycarbonates in IV line components, such as luers.

Like traditional PMMA, this new alloy is resistant to fats (also known as lipids) and plasticisers used in other polymer components, such as polyvinyl chloride (PVC) tubing. Similar to polycarbonate, the alloy is resistant to isopropyl alcohol (IPA) which is used extensively for cleaning medical devices.

Transparent Polyamide: Arkema has also introduced Rilsan Clear G-170 Med, a fully transparent polyamide for use in breathing masks, tubing and other transparent medical components. Rilsan Clear G-170 Med is said to be more transparent than glass, and lighter and more flexible than polycarbonate for applications in which patient comfort is required.

Rilsan Clear G-170 Med is designed for innovative transparent medical device components. Light transmittance of this new medical grade is 91%, reportedly exceeding that of glass. Sterilisation resistant and with a specific gravity of 1.05, Rilsan Clear G-170 Med is said to be 12% lighter than traditional transparent medical plastics, such as polycarbonates, resulting in devices that are easier to carry or wear for extended periods of time. Such complex devices often require flexibility for a better assemble ability and to improve patient comfort or mobility. Rilsan Clear polyamide has a flexural modulus of 2,020 MPa (293,000 psi), representing what Arkema claims is a 16% improvement in flexibility compared to polycarbonate.

<< Arkema’s new medical grade transparent polyamide was presented at MD&M East in June 2013 by US distributor Foster and at Medtec France in May 2013

by European distributor Velox. >> Topas Cyclic Olefin Copolymer Used for

Plunger of OmniPod Insulin Pump Cyclic olefin copolymer (COC) from USA-based Topas Advanced Polymers has been used to make the plunger of the latest model of the OmniPod insulin management system, manufactured by US device maker Insulet, based in Massachusets.

The OmniPod, said to be the industry’s first tubeless and wireless insulin pump, was first commercialised in 2005. The latest model received 510(k) clearance from the FDA in December 2012. The plunger, a two component insert moulded part, has been made from Topas COC since the device was first commercialised. It has been said that Topas COC was chosen thanks to its high levels of purity, drug compatibility, biocompatibility and dimensional stability. The plunger is described as being one of “critical high performance”.

The newly released OmniPod is reportedly 34% smaller and 25% lighter than the original model. It is part of a group of products—the OmniPod Insulin Management System— consisting of the OmniPod, which holds and delivers the insulin, and the PDM (Personal Diabetes Manager), which communicates wirelessly with the OmniPod to programme insulin delivery.

<< The latest model of the Omnipod, seen here sitting neatly on the skin, delivers insulin via a separate wireless programmable system. It features an insert moulded plunger made from Topas cyclic olefin copolymer (COC), whose high level of dimensional stability allows extremely accurate doses to be delivered automatically and continuously. >>

Continued on page 30

MATERIAL DIAGNOSIS Continued from page 28 The plunger is comprised of a stainless steel lead-screw and a fill rod which have together been insert moulded with Topas COC resin. The plunger has an elliptical shape and measures approximately 9.5 mm x 15.9 mm (3/8” x 5/8”).

Topas COC’s “critical high performance” is demonstrated in the mechanical performance of the plunger, especially in terms of dimensional stability. The plunger moves just 0.004 mm (0.000156”) per increment of insulin delivery.

Strict dimensional tolerance of the plunger and lead-screw is critical to ensure accurate dosing of insulin. A very small amount of insulin can have a significant effect on blood sugar levels.

The OmniPod attaches directly to the body and is usable for up to three days of basal-bolus insulin therapy, delivering boluses of insulin after meals and in steady rates throughout the day.

The OmniPod holds 200 units of rapid-acting insulin, which Insulet says meets the needs of most Type 1 diabetes patients’ three-day insulin requirements.

Topas COC’s dimensional stability is also key to the successful management of the interface between the plunger and the insulin reservoir.

The material provides adequate compression to maintain seal integrity.

Commenting, Insulet’s vice president of business development and advanced technology, Kevin Schmid, said: “Topas COC fills an important role in the drive system of the OmniPod Insulin Management System. It’s a wellrespected material because of its drug compatibility and other high-performance attributes.”

Topas COC offers a non-ionic, minimally reactive surface. This non-polar substrate does not promote adsorption, denaturation, aggregation, or precipitation. The company says that these properties are unlike other engineering thermoplastics or glass.

Furthermore, with lower leachables and extractables, Topas says that its resin preserves long-term drug purity, enabling better quality than comparable materials at high yields.

Polycarbonate and PC/ABS Blends Users of medical plastics made by USA-based engineering materials manufacturer Styron can benefit from the services of specialist medical distributor Velox thanks to a recent partnership between the two companies. Styron says that the partnership allows it to link its established medical grades and technologies to a comprehensive European sales network from Velox, meeting the diverse needs of the medical market in more than 18 countries.

The agreement covers Styron’s medical grades of engineering materials—including the Calibre Megarad polycarbonate resins and Magnum ABS resins.

“We look forward to cooperating with Styron and are excited to add their medical products to our product portfolio for the medical market. It is a complementary fit to our current product 30/ MPN / JULY-AUGUST 2013

portfolio of raw materials,” said Francois Minec, general manager at Velox.

“Styron is pleased to join forces with Velox in this new collaboration. Backed by a focused sales force from Velox and Styron’s product development and medical policy, we believe the partnership will be fruitful,” said Nicolas Joly, Styron’s product market manager for polycarbonate, compounds and blends.

Until 2010 Styron was part of US chemical company Dow. Styron has also announced the introduction of new grades and ISO10993-tested colorants.

The new grades are for Emerge PC/ABS 7700 blend as well as its Magnum Mass ABS resin. The ISO10993-tested colorants are for Styron’s Calibre and Calbire Megarad polycarbonate brands and its Magnum ABS resins.

The new Emerge and Magnum grades are being marketed for use in low cost medical equipment enclosures. Emerge is described as offering a “a well-balanced, cost-effective solution for powered medical devices offering ignition resistance and colour stability over time”. The Magnum grades are manufactured in a continuous mass production process which, Styron says, “ensures lot-to-lot consistency of properties including colour, rheology and physical structure”. Mass polymerisation also reportedly allows for lower levels of process additives, resulting in a purer polymer compared to emulsion ABS resins. This high purity is said to result in superior natural resin whiteness and improved thermal stability.

The new Emerge material has a UL flammability rating of V-0 at 1.5 mm and is available as customised pre-coloured pellets.

On March 1, 2013, Styron appointed Martin Pugh as senior vice president and business president, plastics on March 1, 2013. He became a member of Styron’s executive leadership team at the same time.

“We are extremely pleased to name a plastics business president with Martin’s senior strategic experience in the chemical industry,” said Chris Pappas, president and CEO of Styron.

“His vast experience in various plastics businesses and his European-centric career, skills

<< Styron’s newly appointed plastics business president Martin Pugh hopes to grow the company’s profile in Europe from Styron’s European regional operating centre in Switzerland. >> and relationships will help take Styron’s plastics business including styrenic polymers, automotive and polycarbonate compounds and blends (PCC&B) to the next level.”

Pugh most recently worked at Styrolution Group, the global styrenics joint venture between BASF and Ineos, where he served as president for Europe Middle East Africa (EMEA) and as a management board member. He was managing director for Europe of Ineos Nova from the company’s formation as Nova Innovene in 2005 and previously served as managing director for Europe with Nova Chemicals.

Pugh spent 20 years with The Dow Chemical Company serving as global business director for specialty polyethylenes and previously in a variety of sales and marketing roles working in the UK, Dubai, Sweden and Switzerland.

Pugh has a Bachelor of Science degree in Industrial Chemistry and Management Studies from Loughborough University in the United Kingdom.

Pugh will be located at Styron’s European regional operating centre in Horgen, Switzerland.

<< Teijin’s anti-hydrolysis agent is already used by the company to harden its bioplastic Biofront. These glasses, available in Japanese retailers, are testament to the material’s capabilities. >>

Japanese materials manufacturer Teijin has announced the development of a glass fibre reinforced polycarbonate resin suitable for inmould decoration, an efficient method of decorating plastic parts during the injection moulding process. Teijin says that the new resin will allow manufacturers to enhance productivity while reducing product weight.

Potential applications include medical devices, automotive parts as well as casings of mobile devices such as smartphones, tablets and notebooks.

In addition to glass fibres, the resin incorporates additive agents which reportedly gives it the following benefits—excellent rigidity and dimensional stability for thin-wall moulded casings, optimised surface flatness for in-mould decoration, and 40% higher fluidity than conventional glass fibre-reinforced polycarbonate resins. In addition, Teijin’s proprietary flame-retardant technology enables the new resin to achieve top-level flame retardancy—equivalent to UL94V-0 at 0.6 mm.

Cyclic Carbodiimide Anti-hydrolysis Agent Improves Durability of Plastics, No Isocyanate Emissions Teijin has also developed a new cyclic carbodiimide anti-hydrolysis agent which reportedly exhibits desirable anti-hydrolysis properties to improve the durability of a range of general purpose plastics without adversely affecting performance. The range includes PLA, polyesters, polyamides and polyurethanes.

The agent, whose effectiveness has been proven thanks to its use in making Teijin’s PLAbased heat resistant bioplastic Biofront, does not generate isocyanate gas—a toxic chemical usually generated during the use of carbodiimide agents. As a result, companies using it are expected to enjoy improved manufacturing environments. Biofront has been used to manufacture glasses in Japan (see image left).

Effective immediately, the company will begin providing samples to selected customers.

Commercialisation is envisioned by 2015, with a target annual production of 100 tons by 2018.

<< US dental implant company BioHorizons has launched a surgical instrument kit for dentists using Solvay’s repeat sterilisable Radel PPSU for the tray and lid. >> The new agent already complies with various regulations regarding harmful substances in Japan and Europe including REACH, and Teijin says it expects to achieve regulatory compliance in the USA and China.

Teijin says that the new agent can be used in relatively small quantities compared to substitutes thanks to “superior” anti-hydrolysis properties. In addition, because the agent is heat-resistant to at least 300°C, it can be mixed with plastics at higher temperatures. It can also be used as a cross-linking agent to harden or adjust the viscosity of paint and coating agents.

Solvay: Recent Medical Applications of Sulfone Polymer Technology Solvay Specialty Polymers, part of Belgian chemical and plastics manufacturer Solvay, has announced three new applications for its sulfone polymer technology. The applications are: a repeat sterilisable tray and coloured transparent lid of a dental instrument tray (see top image) made from polyphenylsulfone (PPSU), an implantable drug infusion system (see image overleaf ) made from polysulfone (PSU) and a highly durable non-implantable impeller for blowers and fans made from PPSU (see bottom image).

Solvay Specialty Polymers is a global leader in the development of sulfone polymer technology, having launched the Udel brand of PSU nearly 45 years ago. << This impeller for ventilators and CPAP machines is injection moulded using Radel PPSU, chosen for high strength, toughness, and high stress crack resistance. >>

Continued on page 32 JULY-AUGUST 2013 / MPN /31

MATERIAL DIAGNOSIS Continued from page 31 The PPSU dental instrument tray components can withstand repeated steam sterilisation cycles and autoclave temperatures up to 132°C (270°F), reportedly without significant loss of properties.

According to the maker of the tray, USAbased BioHorizons, Radel PPSU was selected over metal and other thermoplastics for its impact strength, transparency, chemical resistance, flexibility, and exceptional sterilisation durability. Boyd Peters, director of implant marketing for BioHorizons, said: “Radel PPSU has been thoroughly vetted and tested. For us, the material has a long history and gives us a high degree of confidence.”

Radel PPSU resin has been chosen for use in an injection moulded impeller for medical ventilators and continuous positive airway pressure (CPAP) machines developed by MUS International, a leading Chinese manufacturer of high-performance miniature blowers and fans.

The material was chosen for its high strength, toughness, and high stress crack resistance. PPSU has replaced competitive materials such as modified polyphenylene ethers (PPE), offering improved stress crack performance.

“Radel PPSU played a major role in improving the performance of our high-pressure impellers,” said J R Schenk, principal of Fisaga Technologies based in California. Fisaga is the US representative and technology development firm for MUS International. “We were also very pleased with the level of support we received from Solvay both in the US and China”, he added.

The impellers and blowers are engineered in the USA and manufactured in China.

The injection moulded impellers range in size from 34 mm to 48 mm in diameter. They consist of an impeller base and a top section which is ultrasonically welded to the base.

Implantable PSU from Solvay has been used to make implantable catheter ports by an Italian designer and manufacturer of medical devices, Plan 1 Health. The resin was chosen thanks to its biocompatibility, dimensional stability, and MRI compatibility. The brand of PSU used is Eviva, part of Solvay’s Solviva biomaterials line for use in implantable medical devices. The resin was used to improve a previous all-titanium model of the port. The catheter port is sold under the Healthport brand.

The new port system, the Plastics Low Profile (PLP) model, is said to be versatile and highly reliable for delivery of drugs, antibiotics, and

nutrient therapy solutions. Furthermore it is lightweight and cost-effective, and features a lowprofile PSU housing that is suitable for all patients.

A titanium inner chamber avoids damage induced by the needle tip and avoids interactions between Eviva PSU and the drug. A large self-sealing septum facilitates location during skin palpation and reduces the risk of puncture concentration. A transparent polyurethane connector allows a rapid, safe, and reversible connection of the catheter.

Shawn Shorrock, global healthcare market manager for Solvay Specialty Polymers commented: “The ongoing acceptance of Eviva PSU has validated our approach to the implantable infusion market and we’re encouraged by the momentum we’ve generated.”

The catheter port is a multi-piece assembly consisting of an injection moulded housing and ring component, both made of Eviva PSU, and a titanium inner chamber. The PLP model is lighter and more cost-effective than previous all-titanium versions which require more expensive manufacturing techniques, according to Alessandro Rainis, product manager for Plan 1 Health. The titanium chamber is fixed between the two plastic components that are ultrasonically welded together.

Medical Plastics News is asking readers to take part in a poll about medical grade polymer resins in return for a chance to win an iPad. The poll includes all brands made by the companies mentioned in this article and is part of an annual research initiative to help improve the supply of biocompatible

32/ MPN / JULY-AUGUST 2013

Eviva PSU is a transparent polymer that offers toughness and strong biocompatibility. The material maintains its dimensional tolerance right out of the mould and requires no machining. It is a rigid thermoplastic that doesn’t absorb fluids and is artifact-free for effective MRI imaging.

The manufacturing site for Eviva PSU and other Solviva Biomaterials in Alpharetta, Georgia, USA, is ISO13485 registered and, according to Solvay, the relevant aspects of current Good Manufacturing Practices (GMP) are also applied.

Solvay’s Solviva Biomaterial manufacturing processes are carefully validated and enhanced controls provide product traceability. In addition, all materials are tested in an ISO17025 accredited lab. Based on biocompatibility testing, Eviva PSU demonstrates no evidence of cytotoxicity, sensitisation, irritation or acute systemic toxicity.

The catheter ports—sold to medical device distributors in Europe, Asia, and India—have earned the CE (Conformité Européenne) mark which demonstrates compliance with numerous EC directives, enabling the product to be sold throughout the EU. Plan 1 Health is also exploring the option of seeking 510(k) clearance from the FDA and entering the US market.

<< This catheter port is made from Eviva PSU from Solvay’s Solviva range of implantable polymers. >>

polymers. The survey is being carried out by DJS Research, an independent research organisation registered as adhering to the UK’s data protection laws with that country’s information commissioner. To take part, please email the word Survey to the editor at sam.a@rapidnews.com.

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The image shows a glucose meter sent to Medical Plastics News by USA-based engineering materials manufacturer Styron. Styron specialises in the manufacture of polycarbonate (PC), ABS and PC/ABS blends.

Styron announced in June that its products will be sold in Europe by specialist medical distributor Velox thanks to a recent partnership between the two companies.

Styron says that the partnership allows Styron to link their established medical grades and technologies to a comprehensive European sales network from Velox, meeting the diverse needs of the medical market in more than 18 countries.

The agreement covers Styronâ&#x20AC;&#x2122;s medical grades of engineering materialsâ&#x20AC;&#x201D;including the Calibre Megarad polycarbonate resins and Magnum ABS resins.

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DESIGN 4 LIFE Design News | MEDICAL PLASTICS

Thermoformed Clamshell for Orthopaedic Devices AND ELECTRONIC MULTIPLE SCLEROSIS MONITOR Clamshell Design Wins US Institute of Packaging Professionals Ameristar Award US medical packaging thermoforming company Barger has won an award from the US Institute of Packaging Professionals (IoPP) for a medical clamshell packaging design.

The award was made on June 19, 2013, at the EastPack packaging trade show in Philadelphia, co-located with the Medical Design and Manufacturing (MD&M) East exhibition.

Barger collaborated with US manufacturer of orthopaedic implants Wright Medical to develop and manufacture the product, a unique small rigid thermoformed clamshell said to provide “high product protection and equally strong enduser satisfaction”.

Key aspects of the design which caught the judges’ attention include the following. l Securely fits approximately 350 SKUs which include Wright Medical’s small parts, screws and plates. l Barger utilised a technique more often seen in the plastic injection moulding industry— instead of thermoforming the clamshell’s hinge in a “W” shape, whereby the hinge is cut on a plane, the hinge instead was coined. l The only potentially sharp areas on the clamshells were on the corners of the hinge.

To assure pouches were protected from this potential area of concern, two rounded “wings” were designed on either side of the package to push the poly bag out and away from the hinge corners when the clamshell is closed.

Scott Duehmig, director of sales, custom and medical divisions at Barger, said: “This is a great example of how collaborating with our customers can lead to exceeding expectations with a design that is simplistic, not only filling today’s requirements but with added flexibility for future products.”

IDC Designs Multiple Sclerosis Monitor with Easy Data Transfer UK-based product design company Industrial Design Consultancy (IDC) has completed the design of an electronic multiple sclerosis (MS) monitor working with the University of London’s Queen Mary college in the UK. The project was to produce a bio-sensor holder and base unit enclosure for monitoring the condition of those living with MS. The product analyses tiny blood samples and measures a specific protein marker, matrix

<< Thermoforming company Barger collaborated with US manufacturer of orthopaedic implants Wright Medical to develop and manufacture this small rigid thermoformed clamshell said to provide “high product protection and equally strong end-user satisfaction”. >>

metalloproteinase 9 (MMP-9), to indicate worsening MS. The product is expected to benefit patients who are known sufferers of MS by detecting inflammation around nerve fibres before the onset of a clinical attack or a relapse.

Patients such as these, on anti-inflammatory therapies, need continual monitoring as treatment is only partially effective. Usually, the only way to monitor inflammation in MS patients is by expensive routine MRI (magnetic resonance imaging) scans or the occurrence of visible symptoms. However, Queen Mary’s bio-sensor aims to provide an important home detection system which is low-cost and which will provide an early indication if therapies are not being effective. This product builds on the success of a previous Queen Mary project with IDC, which developed a bio-sensor for detecting periodontal disease (also known as gum disease).

Working alongside Queen Mary and other partners, IDC was tasked with producing an ergonomic, aesthetic and practical design for both the base unit and the sensor holder. The base unit enclosure was enhanced with a splash proof membrane keypad and a hinged lid which allows the user to insert a disposable foam pad.

This pad prevents the blood sample from evaporating during the analysis process. The removable waterproof sensor holder incorporates a ceramic heater, which maintains the temperature of the bio-sensor chip during the test procedure. The product uses a two-part design with a disposable capillary-fill sampling chip that plugs into the main unit via the heated holder during testing. A small blood sample is placed on the sampling chip, which once inserted must maintain optimum contact with the biosensor at a temperature of 37°C for testing.

One of the aims of the product was to develop a device that allowed data to be easily recorded and transferred. The final design included an SD card slot [SD stands for secure digital, the slot is used to transfer data from high density memory cards found in cameras and other electronic devices] and a USB connector on the side of the device, which allows test results to be exported for monitoring by a remote medical team and generation of long-term patient records.

<< This image shows IDC’s work in designing and developing a multiple sclerosis monitor which allows data to be easily recorded and transferred using a high density memory card and USB connector. >> JULY-AUGUST 2013 / MPN /37

REGULATION REVIEW The Safety Net: Selecting Thermoplastics FOR SAFE AND EFFECTIVE MEDICAL DEVICES

by Josh Blackmore, global healthcare manager, RTP Company.

According to the FDA, there were 49 Class I medical device recalls in 2012. The FDA defines a Class I recall as “a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.” In addition, there were hundreds of Class II and Class III recalls in 2012.

While recalls are often necessary to protect patient safety, they can be extremely damaging to consumer confidence and a company’s brand.

With this in mind, it is no surprise that a primary focus of the medical device industry is patient safety.

During the design stage, key areas to look at include material specification and performance.

The ideal material supplier can collaborate with an OEM to provide design and engineering input, and materials science expertise, demonstrating a pattern of concern for safety.

The performance of a finished medical device is vital to patient safety. To enhance this, compounds used to develop medical devices can be formulated with additives to achieve specific performance properties to ensure the functional and commercial success of the device.

Examples within the healthcare industry can include coloured, conductive and wear resistant compounds.

<< RTP Company has developed a standard line of universal masterbatch and precoloured resin products which meet ISO10993-1 tests for biocompatibility. >>

<< Mexico’s Plásticos y Materias Primas (PyMPSA), a leading manufacturer of medical devices and components for the healthcare industry worldwide, was able to develop an epidural catheter using a custom RTP 2900 Series polyether-blockamide thermoplastic elastomer (PEBA) compound that is radiopaque, so it can be easily observed during x-ray imaging to ensure proper placement. >>

Product recalls, while often necessary to protect the general public, are extremely damaging to a medical device manufacturer’s brand and reputation. In order to increase the overall performance of a medical device, it is vital to demonstrate a pattern of concern for safety from the earliest design stages and throughout the lifecycle of a finished product. This can be accomplished by working with a material supplier that is experienced in developing compounds for medical devices.

Colour-coded surgical devices: biocompatibility testing of pigments Colour can play an important role in medical device safety. Colourcoded medical devices can indicate size, type and function for quick identification during surgical and emergency procedures.

Accident and emergency and operating theatre nurses report that colour coding allows them to quickly locate the right

38/ MPN / JULY-AUGUST 2013

devices, reducing the risk of human error1.

However, it is essential for manufacturers to know that not all colorants are equal. In an effort to reduce potential safety risks, the FDA and other regulatory bodies throughout the world have recently begun to look more closely at colorants, specifically at the biologic testing performed on pigments used in medical device materials. Manufacturers must understand the biologic testing requirements of a medical device in order to choose the right colorant. An experienced colour compounder with medical device market and biologic testing expertise can utilise pre-tested ISO10993 resin and pigment options to ensure the finished product can meet all the biological testing requirements.

Standing up to sterilisation Modern sterilisation techniques are extremely effective methods for increasing patient safety.

They are used to eliminate infection-causing microbials from the surface of medical devices and instruments. But they can have a detrimental effect on some polymers. Many medical devices must be able to withstand harsh environments associated with various sterilisation techniques, such as steam autoclave, ethylene oxide (EtO), hospital chemical cleansers and gamma radiation.

Typically reaching temperatures up to 134°C, autoclave sterilisation can result in polymer

melting, warping, and deformation. Adequate temperature resistance, through the right compound formulation, is necessary to increase the durability of polymers exposed to a steam autoclave. Resin systems such as polyphenylsulfone (PPSU), polysulfone (PSU), and polyetheretherketone (PEEK) can readily accept these high temperatures without damage. To further fortify these compounds, additives or “reinforcements” such as glass fibers (both chopped and long fibres) and carbon fibres can be added.

Low temperature sterilisation methods such as ethylene oxide (EtO) and gamma radiation are becoming the preferred method to sterilise polymeric medical devices in high volume— specifically pre-packaged disposables. However, repeated exposure to EtO or gamma radiation can result in gradual degradation to a polymer, including cross-linking and chain scission. The right polymer must be formulated with the right stabilisation package to ensure the integrity of finished medical devices continually exposed to EtO or gamma radiation sterilisation.

Anti-static compound formulations can reduce these effects, preventing the drugs from obstructing the drug flow path and ensuring the delivery of a proper dose. A supplier with a complete portfolio of solutions can provide innovative anti-static compounds that can greatly increase the effectiveness of these drug delivery devices.

Keeping moving parts lubricated Prolonged contact motion can have a detrimental effect on medical devices, decreasing their ability for safe use. Materials for components, such as valves or gaskets, formulated with a biocompatible internal lubricant can reduce friction rates, vibration and noise. Internal lubricants can also eliminate the need for a topical applied external oil-based lubricant. A competent materials supplier knows that compounds formulated with internal lubricants extend the useful life of medical devices and

Controlling static When delivered through dry powder inhalers (DPI) or pressurised metered dose inhalers (pMDI), the flow of powdered or aerosol drugs over traditional plastic surfaces can generate high levels of static electricity that can cause the drug particles to adhere to the device’s drug flow paths. This can result in the patient receiving an inaccurate dosage of the drug.

reduce the amount of timely and costly maintenance to keep them running safely.

About the author: Josh Blackmore is the Global Healthcare Manager at RTP Company, responsible for strategy creation and implementation, managing the healthcare sales force, and providing healthcare industry expertise.

Reference: 1 Hanson, Scott & Turner, Pachel, “Where Color Meets Clarity” Medical Device & Diagnostic Industry, July 2010.

<< Using an anti-static ABS compound from RTP, respiratory device manufacturer Philips Respironics developed this antistatic drug delivery inhaler. >>

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DOCTOR’S NOTE Alternatives to Animal Testing | EU COSMETICS BAN ENCOURGAES INNOVATION << Dr Laura Waters in her lab at Huddersfield University in the UK. >>

PREDICTING DRUG BEHAVIOUR USING CHEMICAL MIMICS, Biological Systems and Computer Software Simulation

by Dr Laura Waters, Huddersfield University, UK In the EU, as of March this year, animal testing is now banned in the development of cosmetics and similar products. But it is not illegal in the pharmaceutical industry, on the contrary, it is mandatory. This is because all new drugs must be tested on animals before they are given to healthy volunteers in the first stage of clinical trials.

Most people would argue that taking a drug that has never been tested on any mammal is too risky and they feel they need the reassurance that animal testing provides. By initially administering a drug to an animal, such as a dog, it is felt that the first human volunteers to take the new drug are guaranteed some level of certainty as it has already been proven acceptable in animals. So, should we continue to undertake animal testing for new drugs or would it be just as successful to predict drug behaviour in humans using alternative methods?

Research is currently underway to remove the need for animals in the development process and a variety of new techniques are being developed.

To be a successful replacement for using animals any new method would have to replicate the human biological response as closely as possible or be deemed a suitable predictive method. The array of alternatives is continually growing with three major areas of interest; chemical mimics, biological systems and computer software simulations.

Despite how many alternatives are proposed it is unlikely that a situation will ever arise whereby animal testing will be removed in its entirety which I think is a shame. This is partly because animal testing has become so established as part of the drug development process and partly that society is unlikely to accept new medicines unless

they have been researched using animal studies, prior to their market release. This faith in animal testing can be sometimes misled, for example in 2006 a clinical trial went catastrophically wrong when six previously healthy human volunteers took a new drug called TGN1412 and ended up in intensive care.

Before trials commenced, animal studies were undertaken with no adverse effects observed at levels five hundred times higher than those given to the six volunteers. This unfortunate incident shows that animal testing does not always manage to predict unwanted side effects of new drugs before the first studies are conducted in humans.

The biological reactions and interactions that occur when a person takes a drug are so incredibly complicated that it is hard to mimic the exact scenario even with the use of animals as models. In an ideal world there would be no need to use animals at all and hopefully more money and scientific research will be focused on developing suitable alternatives to make this animal-free drug development dream a reality in the near future.

About the author: Laura has an active research group investigating phenomena at the interface of chemistry and pharmaceutics, developing analytical techniques, characterising chemical interactions and enhancing formulations, all funded through external sources. Her work in the area of public engagement has led to several recent public lectures and media presentations including the JPAG Science Award for her research and the British Science Association Darwin Award for public engagement.

In Silico: Software-based Alternatives to In Vitro and In Vivo Testing One organisation leading the development of technology in software-based alternatives to in vivo and in vitro testing is UK-based Lhasa Limited, a not-for-profit members association and educational charity. The organisation offers the latest advances in in silico prediction and database systems for use in metabolism, toxicology and related sciences. In silico means via a computer or computer simulation.

The organisation, which describes itself as a pioneer in the production of knowledgebased systems for forward thinking scientists, offers a broad range of simulation-based toxicity testing and prediction tools for pharmaceutical manufacturers. Examples of tools available include early accurate results, metabolic fate prediction, chemical information management and predicting forced degradation pathways.

Lhasa plays a central role in the pharmaceutical industry in terms of data hosting and management, predictive screening research and pharmaceutical chemical data sharing.

For more information about Lhasa please visit www.lhasalimited.org or contact Matthew Lord at Matthew.Lord@lhasalimited.org.

Editor’s Note: On July 11, 2013, pharmaceutical and diagnostics technology developer Greiner BioOne announced the availability ThinCert cell culture inserts made from biocompatible PET. The company says these offer a real alternative to animal testing.

They provide an artificial environment for in vitro reconstruction of skin cells and are, according to Greiner BioOne, “perfect for cultivating skin cells”. The base of the cell culture inserts features a capillary pore membrane made from PET. The membrane enables oxygen to reach the cells from above while they are simultaneously supplied with nutrients from the multi-well plate below. This is important because skin cells need specific nutrients and contact with oxygen to develop the stratum corneum. The membrane surface is treated in a way that ensures optimum adhesion and growth for the cultivated cells.

Using a scalpel, the PET membrane can be easily removed from the housing, thus also enabling light or electron microscopic tests.

The hanging geometry of the ThinCert cell culture inserts ensures the distance to the well base and the side walls. This prevents capillary suction between the internal and external well walls.

JULY-AUGUST 2013 / MPN /41

K SHOW The World’s Largest Plastics Exhibition | K 2013

K Show Organisers Highlight Technologies FOR MEDICAL PROCESSORS Single-use syringes, cannulas and beyond Be it contact lenses, intubation tubes, single-use syringes or cannulas, more than half of all medical products manufactured around the world are made of plastics.

THE ORGANISERS OF THE But even beyond these massproduced articles, the WORLD’S LARGEST prospects for polymer PLASTICS TRADE SHOW, materials in medical K—SHORT FOR technology look rosy. This is a fast-growing market—and KUNSTOFFE, THE GERMAN one which will remain WORD FOR PLASTICS— expansive and lucrative, given HAVE WRITTEN THE the increasing world population and longer life FOLLOWING ARTICLE expectancy along with rising ABOUT TECNHNOLOGIES expectations regarding health FOR MEDICAL PLASTIC care. At the same time, this is a field governed by a PROCESSORS. permanent pressure to innovate because of the often extremely short life cycles of the products involved. Market experts will have ample opportunity to track the advances made and the growth of plastics in medical applications at K 2013, the international trade fair for plastics and rubber, which is being staged in Düsseldorf on October 16-23.

In the middle of the last century, around 1950, the total volume of plastics produced worldwide amounted to just 1.5 mn tonnes. However, the curve has risen steeply in the following years and decades. Today, some 280 mn tonnes of alternative polymer materials are now being synthesised at locations all over the world. And the requirement for them will continue to grow as our planet’s population increases.

About one fifth of global plastics output is currently produced in Europe.

After China, the European continent is the second-largest supplier of plastics, still ranking ahead of North America, the other Asian states and the Middle East.

Of the roughly 47 mn tonnes of plastics processed in Europe, almost 40% are used for packaging, 21% for civil engineering and construction, only 8.3% in the automotive industry, and 5.4% in the electrical and electronics industry. The rest is spread across such diverse areas as sport and leisure, toys, household goods, furniture, agricultural uses, and—not least—medical technology. No exact percentages are available here because of the blurred distinctions as to where medical technology starts and ends. But one thing is clear: only technically sophisticated and high-quality plastic grades 42/ MPN / JULY-AUGUST 2013

<< The custom-made orsthesis worn by racing cyclist Michael Teuber was made from polyamide by a laser sintering additive manufacturing method using CAD data (photo courtesy of Ortema). >>

find their way into healthcare applications.

The EU: With a growth rate approaching 9% in 2010 and 6% in 2011, the medical technology sector lies substantially above the figures for most other industries, but also quite a bit higher than the rate of growth of Germany’s GDP, which amounted to only 3% in 2011. Turnover by German enterprises in this market has been estimated at approximately €21 bn for 2011 by Spectaris, the German industry association of businesses in the optical, medical and mechatronic technologies. Almost two thirds of this sum (65%) is earned through export business. More than one

<< Plastics can include antimicrobial properties for use in medical devices—including this HyGentic PA from BASF (photo courtesy of BASF) >> third (40%) of these exports go to EU countries, and 12% to other European countries. About 20% of total exports are generated through business with North America, a respectable 17% with customers from the Asian region, although the emphasis here is quite clearly on the Chinese market.

It is interesting to note in this context that, according to Spectaris, the mostly medium-sized companies involved in medical technology invest nearly 10% of their sales in their R&D activities.

This is double the percentage that German companies in general invest in research and development (R&D). It also shows that the sector is not only very willing to innovate but is obliged to do so, and that all sights are set on further expansion. A recently published study undertaken by the German Federal Ministry of Economics, Innovationsimpulse in der Gesundheitswirtschaft, which means Innovation momentum in the health care industry confirms this positive trend. It forecasts annual growth of 5% regarding the growth opportunities for medical technology in the near future.

Of abrasion and deception: Not everything always runs smoothly.

Sometimes, unexpected problems arise with polymer products. For example, knee replacement implants have been known to develop undesirable wear. The plastic lining (generally made of PE) between metal components abrades under the stress it is subjected to. As the Deutsches Ärzteblatt (the German Medical Association’s science journal) writes, this abrasion continuously causes minute particles to be detached which are suspected of promoting wear of the bones around the implant in the long term. Furthermore, it was found during a current research project at the University of Heidelberg that particles also detach from the metal surface. Intense efforts are therefore now being made to reduce the detected wear on implants.

For the stated new study in Heidelberg, the biomechanics specialists at the university are using a motion simulator to mimic the stresses applied to an implant system over a three-year period. The scope of this investigation is not necessarily always the rule, as illustrated by a scandal which shook the otherwise antiseptic and squeaky clean world of medical technology. All the controls and checks had obviously failed here: half a million women from all over the world, including many German nationals, had had breast implant surgery using implants from the south French company Poly Implant

Continued on page 44

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K SHOW Continued from page 43 Prothese (PIP). Some of the implants were made of low-cost industrial-grade silicone that is usually intended for use as a construction material. Reports are that documentation had been manipulated with the intent to deceive inspection authorities, such as the TÜV Rheinland in Germany, which was responsible for certifying the implants.

Feverish efforts are now being made to ensure that such tragic cases will not recur. However, such instances are very much the exception and not the rule, as evidenced by the longstanding symbiosis of synthetic materials and health care. Plastics were already being used in medical technology even before synthetics began to write their commercial success story from the mid 20th century onwards. In 1936, William Feinbloom made the first contact lenses in the USA from polymethyl methacrylate (PMMA), a polymer material that first achieved fame under the trademark Plexiglas. Around 1949, Harold Ridley, another American, succeeded in implanting the first intraocular lens made of PMMA. In later years, this became a standard surgical procedure. Today, however, in some cases the original synthetic material has been replaced by another one: modern intraocular lenses are made of an advanced silicone elastomer.

While early last century, many World War I invalids had to make do with wooden prostheses, the trend to using plastics to make artificial limbs was well under way by the mid 20th century.

Currently, sophisticated composite constructions made of plastics reinforced with carbon fibres (CRP) are being used to make unusual prostheses, such as those used by the exceptional South African athlete Oscar Pistorius (known as Blade Runner). On another scale, the cannulas, single-use syringes and intravenous drip bags which are used in large quantities in hospitals, laboratories or health centres have been on the market since the early 1960s at least, and are available in a variety of plastic materials. And here is another impressive statistic: according to research by the Schmalkalden University of Applied Sciences, a total of 16 bn single-use syringes are used every year around the world.

The trend towards thin-walled components: The demands made on a polymer material intended for use in medical technology were always high, but they have risen even further in recent years. In addition to high resistance to chemicals (including the often very aggressive cleaning substances used in healthcare settings), sterilisability and good optical performance, the processability of the material (for injection moulding, extrusion, welding, and so on) has become an important selection criterion. New requirements have arisen from the continuing trend towards thin-walled components, in order to be able to maintain high quality standards in products for healthcare technology even when saving on material and weight.

The longer life expectancy of people in industrialised nations is also posing new challenges: Implants and regenerative medicine are moving into the foreground as a result of health-related restrictions experienced by an increasingly aging population. The German Society for Thoracic and Cardiovascular Surgery, DGTHG— Deutsche Gesellschaft für Thorax- Herz- und Gefäßchirurgie— recorded a total of 80,000 operations involving heart-lung machines (HLMs) in 1995. A year later, the figure had risen to 87,000, climbing to nearly 100,000 in 2001. Today the number of operations requiring HLMs probably lies at about 200,000.

<< Left: Materials for producing articles for medical technology are tested conscientiously over and over again (photo courtesy of BASF). >> << Below: Shown at Compamed 2012, this model made of synthetic materials was designed to demonstrate the trend towards miniaturisation in medical devices (photo by Messe Düsseldorf) >>

Moreover, almost 70,000 pacemaker systems are implanted annually in Germany, and the number of stents worldwide is estimated at 4 mn. Roughly 55,000 patients in Germany rely on dialysis machines, which consist mostly of plastic materials.

Intramolecular lenses, heart valve prostheses and oxygenerators are required in addition to intracorporal blood pumps and extracorporal heart support systems.

And synthetic materials are required for all of these medical systems, surrogates and implants—not just any such materials, but specific, biocompatible and physiologically safe grades. This is not always easy to achieve, as one example clearly illustrates.

In 2002, more than 1,000 different models of dialysers were being offered on the world market, with membranes made of at least 10 different types of polymers. At a congress staged in Friedrichshafen in the spring of 2012 by the German Society of Engineers, the VDI—Verein Deutscher Ingenieure—a paper by the University of Hannover stressed that the selection of a suitable material for biomedical implant technology can be problematic. The paper was entitled entitled Plastics in Medical Technology and summarised the dichotomy faced by designers of plastic medical devices. Two conflicting aims have to be resolved. A biocompatible material selected for a particular application must not damage the organism around it, but it must also not be impaired in its function by the effects of the biological environment it will be used in.

Silicone resins and silver ions: Silicone resins have won their place among the materials of choice for medical technology applications in everyday clinical use. In terms of volume, they make up 3-5% of all polymers employed in this area. As stated at the VDI congress by

Continued on page 46 44/ MPN / JULY-AUGUST 2013

JULY-AUGUST 2013 / MPN /45

K SHOW Continued from page 43 Wacker Chemie, a large German manufacturer of silicone rubber, the material fulfils the stringent requirements for pharmaceutical applications. The material is said to be not only biocompatible but also free of organic plasticisers and stabilisers and, as a purely synthetic substrate, contains no ingredients of animal origin.

Silicone elastomers, it has been claimed, show good mechanical properties over a broad temperature range and are resistant to a large number of common cleaning agents and disinfectants.

A further benefit of polymer materials on offer to medical processors are grades with antimicrobial finishes. They can help to significantly reduce the number of infections due to microorganisms in clinical environments. Thermoplastics, for example, can be given effective antimicrobial properties through the addition of metallic salts. Zinc oxide is used to avoid discolouration of end products.

Even in low concentrations, silver-based additives can achieve good antimicrobial effects. A new styrene-butadiene block copolymer (SBC) recently launched on the market by German chemical company BASF also contains antimicrobially acting silver ions (see image on page 43). Available in granular form and excellently suited for injection moulding, the new material—says its manufacturer—is highly effective against a large variety of fungi and diverse bacteria.

Moreover, articles for medical use made from the material can be disinfected by conventional methods.

And nanotechnology, too, has long established itself in the health care industry where it is playing an increasingly important role in medical technology in particular. According to Frank SchröderOeynhausen, managing director at the Center for Applied Nanotechnology (CAN) in Hamburg, Germany, it allows the targeted production of completely new materials and the improvement of existing ones. Nanoparticles can be used, for example, to create antibacterial surfaces, coated implants, contrasting tooth fillings or novel nanocomposites. Nanoscale contrast agents can enhance existing imaging processes in diagnostics. And, as Mr Schröder-Oeynhausen reports, nanoscale systems such as liposomes, micelles or polymer nanoparticles can also be used as transport systems to deliver active ingredients directly to diseased tissue.

<< Single-use syringes produced from plastics in an injection moulding machine (photo courtesy of Engel Austria). >>

46/ MPN / JULY-AUGUST 2013

<< View into an injection moulding machine for manufacturing medical devices, for example single-use syringes, from synthetic materials (photo courtesy of Engel Austria). >> Prostheses using additive manufacturing methods: It goes without saying that medical technology also uses advanced product development methods such as additive manufacturing (AM). As the technical journal Plastverarbeiter (in English, plastics processor) writes, the rate of innovation in this field depends to a very large extent on AM of genuinely functioning parts for prototyping. It can be used to configure the first specimen parts right through to prostheses based on existing CAD files, but the methods used in AM offer further attractive opportunities. Within a very short time, series parts can be made from a wide range of different materials, such as plastics, using computer aided design (CAD) data, without the need for moulds.

CAD data and AM helped professional cyclist Michael Teuber back into the saddle and even onto the podium following a traffic accident which resulted in him being paralysed. Through intensive training, the cyclist was able to reactivate the muscles in his thighs.

An orsthesis (see image page 42) now helps to transfer the force from his thigh muscles directly to the pedals of the racing bike. The success of this speaks for itself and for Teuber: the athlete has four paralympic medals—three gold and one silver. The orsthesis, which is to no small extent responsible for Teuber’s success, was produced from polyamide using CAD data and a laser sintering process, a common AM technology.

All the other areas in which plastics help to make people’s lives easier and advance medical technology are excellently documented at the Medica and Compamed trade fairs, a highly successful combination spanning the entire process chain and complete range of medical products, machines and devices. As many as 130,000 visitors streamed to Medica last year, of whom around 16,000 were specifically interested in what Compamed had to offer. Taking place again this year on towatds the end of November, these two events provide yet another opportunity to learn all about current developments in medical technology, beyond the cannulas, singleuse syringes and other mass-produced articles. A month earlier, on October 16-23, K 2013 will open another window on the topic when the halls with exhibiting machine manufacturers will be revealing the latest trends in manufacturing medical products by the various processes involved for engineering plastics.

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MEDIPLAS PREVIEW Specifically Medical, Specifically Plastics | EVENT PREVIEW

UK Materials Supplier On Hand to Explain Best Practice in Formulation Change Control On September 25-26, 2013, the only trade show dedicated to medical plastics, Mediplas, will open its doors to the public. The event, located at Birmingham’s National Exhibition Centre (NEC) in the UK, is being held for the second year in a row alongside the UK’s leading trade show in additive manufacturing—TCT. Mediplas differentiates itself from general plastics shows, as it brings to the forefront the aspects and considerations of medical device manufacturing that do not feature in production for other industries. Furthermore, it is distinct from existing medical device shows because it specialises in plastics—a key material of choice for medical device makers .

One of the UK’s leading suppliers of polymers to medical processors is Albis UK. The company, based in Knutsford in Cheshire, will be exhibiting their wide range of biocompatible polymers from stand H12. Albis is a specialist distributor and compounder with proven technical prowess in medical grade engineering polymers. It represents many of the world’s largest polymer producers. It is able to provide sophisticated advice on materials selection to designers and manufacturers of medical devices.

A key issue facing quality control officials at medical device manufacturers is that of remaining up to date with any changes to ingredients used in formulations used to manufacture devices ahead of those changes taking place. Device makers have to manage supply chains consisting of three tiers of suppliers, sometimes more.

It’s a complicated issue. So we spoke to Ian Rogers of Albis to find out how, as one of the most important materials suppliers in the UK, the company uses its experience to help customers.

gives its customers time to notify the regulators of the change and re-validate the modified material or make a complete change to maintain compliance in the marketplace.

Q: That’s helpful for the readers. And what other activities do you carry out to help customers manage their regulatory exposure?

Q: What variations are there between materials suppliers in terms of their approach to the issue?

A: Albis offers to its customers a dedicated technical service with significant experience of the healthcare sector. This works most effectively when used at the start of a project development and includes assistance with impartial advice on material selection and tool design etc before expensive decisions are made.

To aid designers with initial material selection criteria we have developed the Medical Product Guide—detailing the approval status of each generic material type and the relevant sterilisation methods that can be employed in each case, of polymer materials within our portfolio.

We market and stock a wide range of accredited brands of polymers for use in healthcare applications. We both distribute direct from the producer but also can tailor make products under license to meet specific customer requirements ensuring regulatory accreditation is maintained. We manufacture at both our parent facility in Germany and our UK plant in Knutsford.

We maintain good dialogue with our suppliers, looking to standardise on notification periods, and ensuring our customers are promptly informed of any potential changes.

The Albis Healthcare team is experienced and well established and respects totally the confidentiality surrounding projects and we try to develop a close working relationship with our customers to help increase chances of success.

Q: Tell me more about the issue over change control in the medical device sector?

Q: How does Albis help its customers?

A: Change control is an important issue for medical device quality control professionals. It’s also known as formula lockdown and refers to the phenomenon whereby a supplier of a material agrees to provide a minimum period of notice before changing ingredients in a material formulation or making a material obsolete.

When an ingredient changes, a medical device manufacturer must inform regulators of those changes in order for the device to maintain its clearance in the market. A supplier who doesn’t tell its customers that it has changed one of its ingredients is at risk of making the manufacturer liable for any issues caused as a result of the change. By contrast, a supplier who agrees to give notice when changing ingredients

A: There are variations from one manufacturer to the next when it comes to change control policy.

Many of the suppliers we represent have specific policies in place when it comes to notification of change control relating to medical polymers.

They provide a notice period that they plan to change one or more ingredient in one of their polymers. This period varies from supplier to supplier but will typically give a two year timeframe, and sometimes longer. The minimum requirement is that a supplier tells a manufacturer when they have changed an ingredient.

But smaller suppliers, perhaps new entrants in the medical device sector, may not fully understand the device manufacturer’s position with respect to what happens when an ingredient changes. When these companies do not inform their customers that they have changed one of their ingredients, no matter how small, this can cause a problem for a device manufacturer.

Suppliers change formulations more often than one might expect, not always with due regard to the consequences further downstream.

Even if the change does not have a noticeable effect on the properties of the end material, a change means a device manufacturer must recertify the device and its component material.

Changes occur for many reasons often for reasons outside the producer’s control.

A: Albis has in place a risk management system for all healthcare applications to help ensure from the outset that the correct product is specified for the use intended and that customers are given the appropriate recommendations from the earliest stage of their development. This process protects customers from potentially costly mistakes in material selection.

At the outset of a development request, the risk and suitability of a proposed polymer will be assessed carefully to ensure suitability for the application and this is overseen on a global basis by the Albis Healthcare Competence Team. A robust record system will track the history of the project and approvals, and will be retained electronically.

About Albis:: Albis UK was established in 1966 and operates close to the UK’s motorway network. The company is responsible for the distribution of the following ISO10993 and USP Class VI certified polymers: Bayblend PC/ABS, Makrolon PC, APEC PC-HT and Desmopan TPU from Bayer MaterialScience; Pocan PBT and Durethan PA6 from LanXess; Novadur HD ABS, Luran HD SAN , Terlux HD MABS, Xylar MBS & NAS SMMA from Styrolution; Purell PP and PE from LyondellBasell; Eastar, Durastar, Provista and Tritan copolyesters from Eastman; Ultraform Pro POM and Ultradur Pro PBT from BASF; Udel PSU, Radel PPSU, Avaspire PAEK and Ketaspire PEEK from Solvay Specialty Chemicals. It also looks after Evoprene TPE from AlphaGary, where grades conform to ISO10993-5.

Of these brands, Makrolon, Pocan, Novadur HD, Luran HD, Terlux HD, Purell, Eastar, Tritan, Durastar, Provista, Ultraform Pro and Ultradur Pro have Drug Master File (DMF) listings.

JULY-AUGUST 2013 / MPN /49

MEDIPLAS PREVIEW Conference | CONFIRMED SPEAKERS

Mediplas Publishes CONFIRMED SPEAKERS Mediplas has published details of nine confirmed speakers for the free conference accompanying the trade show in September.

As of July 24, 2013, the speakers were: Sarah Egan, Gabriele Frediani, Anthony Goff, Stephen Jenkins, Aaron Johnson, Erik Kroeze, Simone Maccagnan, Paul Shipton and Chris Smith.

Sarah Egan is medical product manager at Granta Design in the UK. Her paper will cover materials information in medical device design and will give tips on how to minimise delays in development.

Aaron Johnson is marketing manager at US micro moulding experts Accumold. His presentation is entitled Converging Technologies—The Latest Trends in Micro Moulding.

Gabriele Frediani of the Queen Mary University of London, School of Engineering and Materials Science, will talk about new biomedical and bioinspired mechatronic systems based on electroactive elastomeric actuators. The abstract of his presentation is as follows.

The development of a variety of new biomedical and bioinspired mechatronic systems poses challenges that share the need for innovative technologies for electromechanical transduction, so as to enable applications not feasible or even imaginable with conventional approaches. To address this need, new technologies based on electromechanically active polymer (EAP) transducers are progressively emerging as a promising solution.

The idea is to use “active smart materials” that exhibit an inherent mechanical response to an electrical stimulus, so as to design radically new electrical devices characterised by lightweight, mechanical compliance, compact size, simple structure, low power consumption, acoustically silent operation, and low cost. EAPs offer such properties and are referred to as “artificial muscle materials”, because of their ability to undergo large and controllable deformations upon electrical stimulation.

This talk will be focused on the most versatile and performing EAP technology, known as dielectric elastomer actuators. Following a brief overview on the field and on the underpinning physical and engineering fundamentals, the talk will present some devices and applications under development by our group, including wearable haptic displays for vibro-tactile feedback in virtual reality systems, variable-stiffness orthotic systems for motor rehabilitation of the hand, refreshable Braille displays as portable tactile readers for the blind people, and bioinspired systems for artificial vision.

According to his LinkedIn profile, Anthony Goff is technical manager at UK plastics moulding training and consultancy firm G&A Moulding. His paper will focus on moulding process optimisation and validation. It will provide an overview of how using a robust methodology broken down into key components and critical process parameters aligned with G&A Pro-Op software can help deliver tangible benefits.

Stephen Jenkins is managing director at LPD Laboratory. His presentation title is Technical Industrial Problem Solving and Failure Investigation. The paper will look at techniques and analytical methodology for establishing the causes and solutions to problems with products that incorporate a range of materials. It also includes any associated manufacturing processes.

50/ MPN / JULY-AUGUST 2013

Erik Kroeze is biomaterials sales manager for Europe, Middle East and Africa at poly lactic acid (PLA) polymer manufacturer Purac.

His talk will look at applications for bioresorbable lactide-based polymers in medical devices.

Simone Maccagnan is sales manager for machinery manufacturer Gimac based in Italy. His paper will cover the potential of microextrusion and will include application examples.

Paul Shipton is consultancy director at UK plastics and rubber testing consultancy Smithers Rapra. The presentation is about polymer materials selection in the medical industry.

Chris Smith is NBD manager at polymer manufacturer Teknor Apex in the Netherlands. His presentation will provide an overview of the challenges and possibilities for TS rubber and PVC replacement in the medical sector.

Mediplas EXHIBITOR LIST Albis (UK) Ltd Algram Group Limited Applied Coating Technologies Ltd Association of British Healthcare Industries (ABHI) Avery Dennison Carville Limited Classic Industries Connect 2 Cleanrooms Ltd Durham Duplex & HSC (High Speed Carbide) Ensinger Fibracon-Insoll Machined Medical Plastics FocalSpec Oy Henniker Hothouse Product Development Partners Komax Systems LCF SA Lohmann Technologies MeddiQuest Limited Medical Plastics News Magazine MEDILINK UK Med-Tech Communications Ltd Metrology Direct MG Stuma Ltd MOLDEGAMA, S.A. National Physical Laboratory Nordson EFD OGP UK OSCATech microinyeccion R. W Simon Lmited Rack Storage UK Ltd RJG Inc. Seaborne Plastics Ltd Smither Rapra | Smithers Pira St Davids Assemblies Ltd Sunala Limited University of Bradford University of Warwick Velox GmbH Videojet Technologies Ltd Wittenburg B.V. Zwick

H12 J20 J7 J25 J24 J36 H16 J10 G2 F1 G12 H8 H19 K27 J8 J28 J12 G4 J32 J32 K11 H32 G8 J18 H24 G16 J27 H7 J23 H9 J11 K23 J9 H5 H36 H6 H15 H5 J16 J35

Confirmed exhibitors as of July 23, 2013.

For the latest list visit www.mediplasuk.com/sessions.html.

MEDIPLAS PREVIEW Medical Plastics | AND ADDITIVE MANUFACTURING

Who to See at TCT Plastics are used extensively in medical additive manufacturing applications, both in terms of rapid prototyping and short run manufacturing of customised devices.

In July 2013, the FDA gave emergency approval for an additively manufactured bioresorbable polymer tracheal splint to be implanted into a baby in the USA (see page 8).

In February 2013 the FDA gave 510(k) clearance for the world’s first long-term plastic implant made using additive manufacturing—the OsteoFab Patient Specific Cranial Device (OPSCD) manufactured by USA-based Oxford Performance Materials (OPM), manufacturer of PEKK (polyetherketoneketone) polymer compounds, stock shapes and customised additive manufactured products. OsteoFab is OPM’s brand for additively manufactured medical and implantable parts produced from its OXPEKK brand of biocompatible PEKK polymer.

OPM works closely with Holland-based Xilloc, a leading manufacturer of custom manufactured implants.

<< This implant was custom manuactured using additive manufacturing with PEKK. Source: Xilloc Medical. >> Given the growing importance of additive manufacturing in the medical plastics sector Medical Plastics News thought it would be useful to highlight one of the confirmed speakers at TCT and provide a list of the exhibitors.

The confirmed speaker of note is Jari Pallari, R&D manager at UK manufacturer of medical equipment Peacocks Medical Group.

Dr Jari Pallari has been working on medical applications utilising additive manufacturing since 2003. He received his PhD from Leeds University in 2008 and an MSc from the Helsinki University of Technology in 2003, both in mechanical engineering. Until 2011 Dr Pallari worked for

Materialise in Leuven, Belgium, on applications utilising additive fabrication for orthotics and prosthetics applications. Peacocks specialises in the provision of customised orthotics, special footwear and other medical devices. He also acts as the technical manager of the A-Footprint EU FW7 project.

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TCT EXHIBITOR LIST 3T RPD Limited F27 Alchemie Ltd B22 Alpha Lettering Systems A24 Altair Engineering Ltd F46 AME Group Ltd D42 AMUG B39 Arcam AB E28 Armstrong Mold Corporation B41 Beijing Tiertime Technology Co. Ltd E42 Black Country Atelier F45 Breuckmann 3D Scanners A23 BluePrinter ApS C42 Bright Minds Education Programme F47 British Design Innovation A17 CA Models B36 Cadventure C32 cb-printer F41 CDG ProJet 3D Printers A19 Central Scanning B23 CGI 3D Scanning G24 Citim GmbH A18 CMA Moldform Ltd B21 Concept Laser B16 Coventry University Enterprises Ltd B20 Cubify D36 Cubify3D.co.uk A22 Denford Ltd E42 Develop3D D40 Digital Metal D17 DSM Functional Materials Inc. C21 DWS S.r.l F32 Engineering Magazine H39 Envisiontec UK C18 EOS Electro Optical Systems Limited F18 ES Technology B16 Europol A20 Europac 3Dimensional C24 Europol A20 EXCELTEC Sarl F34 ExOne E26 Faro Technologies UK Ltd C20 Freeform Fabrications Ltd B24 Global TCT A38 GTMA A16 GOM UK Ltd G39 Guangzhou Seal Laser Rapid Prototype Co. Ltd D39 Hanman Advanced Castings A28 Hexagon Metrology (UK) Ltd G35 HLH Prototypes Co. Ltd D38 Hofmann Innovation Group B16 ICR3ATE F46 IPF 3D Printing F25 John Burn Co. Ltd C42 Kaidex Limited B17

Laser Prototypes Layerwise N.V. Legor Group SpA LMI Technologies LPW Technology Ltd MachineWorks Ltd Magicfirm LLC Materialise NV Mcor Technologies Limited Measurement Solutions Limited Mech Innovation Limited Midas Pattern Co. Limited MPA Group netfabb GmbH New Design Magazine Nikon Metrology UK Ltd Ogle Models & Prototypes Ltd Omega Plastics PDR Physical Digital Ltd Poly-Shape S.A.S Polygonica Print-IT 3D Propshop Proto Labs Ltd Rapid News Communications Group QMT Magazine Quill Vogue Rapid Sheet Metal Realizer GmbH Renishaw Plc RepRap Hub RepRapPro Ltd RP Mouldings Ltd Rutland Plastics Limited Shenzhen Esun Industrial Co. Ltd SLM Solutions GmbH Solidscape UK Solidtec GmbH SpaceClaim Corporation Stanford Marsh Group Star Prototype China Ltd Steinbichler UK Ltd Strand7 UK Ltd Stratasys GmbH TEKNA Plasma Europe SAS Triformica Ltd Tri-Tech Engineering Ltd Ultimaking Ltd University of Wolverhampton Voxeljet Werth Metrology Workstation Specialists

Confirmed exhibitors as of July 23, 2013.

For the latest list visit www.tctshow.com/exhibitor_List.html.

F42 F26 G28 G25 B42 G33 C34 D33 D18 G38 G25 C43 B19 G27 H39 A39 G42 B26 G37 B37 C35 G33 E40 E40 G30 E38 A27 F40 C38 F24 D24 G54 F58 H27 D31 E39 B32 B24 F28 B25 D44 F38 F20 F36 E20 B15 D28 H23 D45 G36 A38 C36 A42

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PRODUCT FOCUS Minimally Invasive Devices | PLASTICS HELPING SURGICAL EFFECTIVENESS

Supplier News Fluoropolymers for Cryoablation Catheters and other Speciality Catheter Compounds Specialist producer of extruded tubing used for minimally invasive devices Putnam Plastics, based in the USA, has written about its capabilities in manufacturing tubing that may be used for cryoablation devices.

High temperature ablation devices use radio frequency (RF), ultrasound, microwave or laser technology to destroy unwanted cells within a temperature range of approximately 45-50°C (113-122°F). These approaches have been used by surgeons to destroy unwanted tumours in surgical and minimally invasive procedures for years. Today, vascular catheters using RF technology are commonly used to ablate heart muscle cells to control irregular heart rhythms associated with atrial fibrillation.

Cryoablation uses low temperatures to destroy cells at temperatures between -40°C and -20°C (-40°F and -4°F). Previously, cryoablation devices were relegated to surgical procedures due to the large probes necessary to deliver cooling gas to the site. In recently years, percutaneous cryoablation devices, primarily using argon gas, have been used in conjunction with magnetic resonance frequency (MRI) and computed topography (CT) image guidance to destroy malignant cells in the liver, kidney and prostate. As recently as December 2012 vascular catheters used for cryogenic ablation were approved by the FDA for treatment of atrial fibrillation.

For catheter device engineers, low temperatures pose new design considerations. As with many interventional vascular catheters, the shaft must have sufficient mechanical properties to navigate vascular pathways to the designated site. The proximal end must have sufficient rigidity for pushability and torque by the physician, while the distal end must be flexible and minimise trauma. Additionally, the tip of the catheter must not become brittle and crack at sub-zero temperatures associated with cryogenics.

Tips for these catheters will likely use distinct polymers which are more suitable to low temperature performance. Fluoropolymers, such as polytetrafluoroethylene (PTFE), are well recognised for property retention at low temperatures; however, PTFE is not melt processible in conventional extrusion. Fluorinated ethylene propylene (FEP) and polyvinylidene fluoride (PVDF) are melt processible fluoropolymers suitable for extrusion into complex catheter designs.

These complex requirements will likely

54/ MPN / JULY-AUGUST 2013

demand shafts with varying performance characteristics throughout the cross section and along the length, using varying materials of construction. Composite shafts have traditionally been assembled manually from multiple extrusions over a mandrel and then fused together by heat (known as “hand layup”).

However, the cost and complexity of such assemblies pose economic and quality challenges for production components. Continuous extrusion technologies that incorporate fluoropolymers or other low temperature resistant materials in necessary sections of traditional catheter designs for cryogenic catheters are expected to be in increased demand.

Speciality Catheter Compound Reduces Scrap A speciality compound developed by medical compounder NEU, owned by US polymer manufacturer PolyOne, has enabled Chinese manufacturer of minimally invasive surgical catheters FinLumen to reduce scrap rates by a reported 50%. FinLumen manufactures catheters for device OEM Demax Medical Technology.

Materials for surgical catheters were shown at Chinaplas 2013 at PolyOne’s booth on May 2023 in Guangzhou, China. PolyOne acquired NEU, formerly New England Urethane, in December 2009. As a rapidly growing company specialising in devices for interventional cardiology, Demax set up FinLumen to provide extrusion capabilities. In addition to a specific material for its catheters, FinLumen was looking for a materials supplier that could provide guidance in plastics processing, material selection and regulatory compliance for extruded products.

NEU worked closely with FinLumen to gain a better understanding of the application’s needs, from end-use constraints to manufacturing and total cost considerations. The team identified significant in-service performance targets as well as regulatory and manufacturing process requirements before developing an effective solution. The custom solution developed by NEU enables FinLumen to produce catheters for Demax to the exacting specifications required for making extremely small-diameter tubing used in minimally invasive surgery.

“Catheters used for cardiac surgery require medical grade polymers that can meet key criteria, including radiopacity. When we were unable to find suitable materials, we turned to NEU, a company known for custom solutions,

processing expertise and extensive knowledge of medical device regulations,” said Bike Qiu, chief technology officer, FinLumen. “The custom solution that NEU developed enabled us to improve the quality, performance and appearance of our catheters and reduce scrap while cutting overall costs for the customer.”

Foster Introduces Propell Lubricious Compounds For Reduced Friction Catheter Shafts US compounder Foster Corporation, a producer of custom polymers for medical devices, has introduced ProPell thermoplastic polyurethane (TPU) and polyether block amide (PEBA) compounds for medical catheters. The compounds reduce tackiness and friction in soft, flexible polymers while maintaining other physical properties of the unmodified polymers.

Soft grades of TPU and PEBA polymers, with hardness properties ranging from 80 Shore A to 35 Shore D, are commonly used in medical catheters that require flexibility to navigate vascular pathways without causing trauma. Yet, the inherent high friction and tackiness of these polymers causes handling problems during catheter tube extrusion and packaging since the parts stick to each other. Catheters made from these materials can also be difficult for physicians to handle and push through vascular pathways.

ProPell low friction compounds use a proprietary, non-migratory additive that enhances the surface of parts without substantially altering the physical properties of the polymer. Tests show that parts produced from ProPell TPU have a dry coefficient of friction of 0.05, representing a 66% reduction compared to the unmodified TPU polymer with a hardness of 80 Shore A. The results are even more pronounced in PEBA polymers with a hardness of 35 Shore D. Parts made from ProPell PEBA have dry coefficient of frictions 84% lower than the unmodified polymer, while maintaining similar tensile strength and elongation properties.

“Catheter manufacturing engineers have put up with the tackiness inherent in many soft polymers because they are otherwise great for flexible, traumatic components,” said Amar Nilajkar, application development manager for Foster Corporation. “ProPell compounds were designed to maintain all the great physical properties of these materials while providing a smoother, lower friction surface in medical device components.”

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Minimally Invasive Devices | PLASTICS HELPING SURGICAL EFFECTIVENESS

Catheters in Minimally Invasive Devices: OEM PRODUCT ROUNDUP In 1969, radiologist Dr Charles Dotter, regarded by many as the father of interventional radiology, successfully implanted a prototype stent into a dog’s femoral artery. Since then the modern day stent has gone from strength to strength. In 1977, the first coronary balloon angioplasty was carried out by a German doctor in Switzerland. In 1985, the first balloon expandable stent was patented. Following the development of the first bare metal stent in 1986, the first drug eluting stent was implanted into a human in 1999.

All minimally invasive procedures require catheter tubes to gain entry to the body. The following paragraphs contain a short summary of recent product news from manufacturers of catheterbased minimally invasive devices.

On June 6, 2013, USA-based Teleflex Incorporated, announced the acquisition of Eon Surgical, a late stage development company that has advanced a minimally invasive microlaparoscopy surgical platform technology designed to enhance surgeons’ ability to perform scarless surgery while producing better patient outcomes.

Microlaparoscopy, unlike NOTES (natural orifice transluminal endoscopic surgery) or single incision surgery, provides surgeons a mechanism for performing minimally invasive procedures without significant changes in technique. The technology has the ability to be utilised for an entire procedure or as an adjunct to existing approaches that require additional access without adding to larger incisions.

On June 4, 2013, US device maker Abbott announced the publication of positive outcomes from two European post-approval studies of the first-in-class catheter-based MitraClip therapy for the treatment of mitral regurgitation (MR). Results from Access-EU, a European prospective study that enrolled 567 patients at 14 sites, have been published in the Journal of the American College of Cardiology.

In addition, findings of the investigator-sponsored German Transcatheter Mitral Valve Interventions (TRAMI) registry, which enrolled 1,064 patients at 20 German sites, were recently published in EuroIntervention.

Abbott’s MitraClip System, which received the CE Mark in 2008 and is commercially available in Europe and other international markets, is an investigational device in the United States. The device is delivered to the heart through the femoral vein, a blood vessel in the leg, and is designed to reduce MR by clipping together a portion of the leaflets of the mitral valve to allow the heart to more efficiently pump blood.

On June 4, 2013, Medtronic announced that the Pacific Plus percutaneous transluminal angioplasty (PTA) catheter had received FDA clearance and the CE mark. The launch of the new peripheral balloon catheter is underway in the United States and internationally.

Indicated for the treatment of narrowed arteries in a variety of locations within the vasculature, including the renal, iliac, iliofemoral, femoral, popliteal and infrapopliteal arteries, the Pacific Plus PTA catheter is said to epitomise versatility. It features a hydrophilic coating for improved crossability, and enables fast deflation, which may shorten procedure time.

“Vascular specialists have been eagerly awaiting the Pacific Plus PTA catheter,” said Dr Juan Pablo Zambrano, director of cardiovascular medicine at Jackson South Community Hospital in Miami. “The device’s ease of deliverability and various shaft lengths provide us with a flexible solution for both straightforward and complex cases.”

On June 4, 2013, medical device company St Jude Medical announced it had received FDA approval to begin the EnligHTN IV Renal Denervation Study, the first US trial using the EnligHTN MultiElectrode Renal Denervation System to treat patients with drug-resistant high blood pressure.

It is estimated that one in three American adults has hypertension, often referred to as high blood pressure—a condition that increases the risk of heart attack, stroke and kidney failure. Hypertension occurs when blood pressure in the arteries is elevated, requiring the heart to work harder than normal to circulate blood throughout the body.

<< St Jude Medical’s EnligHTN renal denervation system uses ablation therapy to treat patients with drug-resistant high blood pressure. >>

“Sub-optimal blood pressure control is the most common attributable risk for death worldwide,” said Dr William B White, professor and chief of hypertension and clinical pharmacology in the Calhoun Cardiology Center at the University of Connecticut Health Center in Farmington and co-chair of the EnligHTN IV steering committee. “Despite the availability of several effective drugs, approximately 50% of patients have inadequately controlled blood pressure and 8-12% are considered resistant to these medications. Renal denervation therapy may be an important advancement for these patients.”

<< In March 2012, Medtronic received FDA approval and the CE mark for this cryoablation device—the Arctic Front Advance Cardiac Cryoballoon— to treat atrial fibrillation. >>

RESEARCHERS DEVELOP ENDOSCOPE AS THIN AS HUMAN HAIR A report on healthline.com, published in March 2013, states that an endoscope as thin as a human hair has been developed by researchers at Stanford University in California, USA. The source of the information is the journal Optics Express.

Image resolution is claimed to be four times better than previous devices of a similar design.

A press release from Stanford states: “The prototype can resolve objects about 2.5 microns in size, and a resolution of 0.3 microns is easily within reach. By comparison, the naked eye can see objects down to about 125 microns.”

JULY-AUGUST 2013 / MPN /57

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DIAGNOSTICS Product Focus | USING PLASTICS TO CLASSIFY CELL TYPES

Innovation in Diagnostics Technology KEY TO KEEPING HEALTHCARE AFFORDABLE MedTech Europe is the umbrella organisation representing both European diagnostics and medical device manufacturers.

The diagnostic sector is broad “THE DIAGNOSTICS reaching. Products range from diagnostic monitoring INDUSTRY IS CRUCIAL electronic instruments for measuring IN MANAGING respiratory rate and other vital signs HEALTHCARE to small disposable plastic assays to the presence of certain cell SPENDING”. THIS identify types in a sample of fluid or tissue— QUOTE FROM JOERG like cancers, bacteria or viruses.

KRUETTEN, A LEADING A key technical component when cell types is surface EUROPEAN STRATEGIC analysing engineering and microfluidic CONSULTANT IN THE technology. The following articles MEDTECH SECTOR AND comprise recent plastics engineering for diagnostic HEAD OF THE MEDTECH technologies applications.

COMPETENCE CENTRE, WAS PUBLISHED BY MEDTECH EUROPE ON ITS WEBSITE ON MAY 15, 2013.

Engineering Plastic Surfaces to Influence Cellular Behaviour in Biological Assays

Working to Surface Thicknesses of 20-50 nm: Germany-based original equipment manufacturer Greiner Bio-One, whose moulding expertise dates back to 1953, has written the following discussion about developing customised platforms for the life science sector using injection moulding and surface engineering technology.

The selective and reliable control of the interaction of biomolecules with a polymer phase such as an organic functional layer and solid substrates is one of the major current development topics. In this context, nanobiotechnology can be seen as a young and rapidly developing field at the crossroads of biotechnology and material science which is able to solve problems with the utilisation of novel biological e has been assays. << Figure 1: This surfac minimise or ls, cel el Several methods of rep to d engineeree it from ng nti polymer modification eve pr n, sio he ad cell encouraging stem are the toolbox for the interacting with them, generation of cells to reproduce. >> functional layers with specific characteristics in order to be able to meet the needs of applications such as tissue culture or microarray technologies in the best possible way.

In addition, the combination of thin functional layers with nanostructures

can be the solution to overcome the remaining challenges and to provide the best possible platforms to be able to open the gate to new applications and assays.

Presently, the main focus of product developments comprise of the following.

Optimisation of cell adhesion of sensitive cell lines: In general, the propagation of cells and tissue in vitro can be challenging and, therefore, synthetic surfaces to support the cell cultivation are of great interest. These non-biological polymer modifications are mimicking the cellular surrounding to positively influence the cell adhesion.

Ways of minimising the cell adhesion (cell repelling surface) are of interest in the field of stem cell research. To be able to meet this need, the successful surface needs to prevent any interaction with cells, either by ionic, covalent coupling or hydrogen bonding means, together with the need to be e-beam or gamma sterilised without loss of performance. Similar surfaces can be used for preventing the protein adsorption in the context of high throughput screening (HTS) applications. HTS uses robotics and other advanced technologies to conduct many thousands, even millions, of tests at once.

Enzyme-linked immunosorbent assays (ELISAs) use peptides, antibodies and proteins with colour changes to identify a substance.

The method relies on ionic adsorption to immobilise the biomolecule. Therefore, physico-chemical forces such as hydrophobic bonds, hydrophilic interactions and H-bonding are relevant.

Polystyrene, the most widely used material for immunological microplates, has hydrophobic characteristics. Because for most ELISA applications the presence of hydrophilic groups is beneficial, several physical treatments are established in order to generate hydrophilic, polar and protic chemical groups on the surface.

In the last decade the covalent immobilisation of antibodies, proteins and DNA became a topic of great interest within microarray technology. The challenge here is the synthesis of a surface with a suitable contact angle for an optimal spot morphology, a high binding capacity to reach a satisfying sensitivity as well as reduced non-specific binding.

The solution and alternative to the first generation layers, formed via a sol-gel process, are organic 3D architectures with 20-50 nm thickness. The sol-gel process is a method of producing solid materials from small molecules using a combination of a sol (coloidal solution) and a gel.

With these platforms the microarray technology can be used in many applications such as genotyping in clinical diagnostics and expression profiling.

Hydrophobic materials are mainly used in protein crystallisation platforms. The reliable and stable, biocompatible, hydrophobic surface can be the crucial benefit for the crystallisation of membrane proteins in small volumes and in buffer solutions with certain detergents.

These manifold developments prove the advantages of surface Continued on page 60 JULY-AUGUST 2013 / MPN /59

DIAGNOSTICS Continued from page 59 modification for biotechnology and biomedical applications.

Upcoming challenges will deal with biocompatibility and the enhanced use of these techniques in medical devices.

For more information please contact Greiner Bio-One in the UK at oem@uk.gbo.com.

Fused Deposition Modelling Used to Develop Prototype of Plastic Haemostatis System Part Fused deposition modelling (FDM) rapid prototyping technology has been used by in vitro diagnostics equipment manufacturer Instrumentation Laboratory. The technology was used to develop a prototype part during reengineering of the company’s ACL Top 500 haemostatis system. The ACL Top 500 was reengineered to make it less expensive to manufacture.

The part is a reagent base, a tray at the base of the equipment which secures reagent vials for cooling during the blood analysis process. The ACL Top 500 system tests blood samples to evaluate whether a patient has a coagulation (the ability for the blood to clot following bleeding) disorder.

The provider of the FDM technology is Fortus, part of US manufacturer of additive manufacturing machinery and materials Stratasys.

According to the companies involved, the use of FDM rapid prototyping saved a fair amount of cost compared with their previous virtual prototyping process.

“We were able to re-engineer over 25 parts at a cost saving far greater than could be realised with traditional virtual prototyping methods,” said Scott Notaro, manager of mechanical engineering at Instrumentation Laboratory.

“FDM helped us achieve a manufacturing cost reduction of 40%. That’s 10% [percentage points] more than the traditional approach would have offered.”

According to Stratasys, the 10% savings amounted to $600,000 per year. Extended over the 12-year life of the product, this represents a US$7.2 mn cost reduction. The company also saved $50,000 in mould rework and delivered the product to market six months earlier than expected with traditional methods.

<< A fused deposition modelling (FDM) prototype of a plastic part for Instrumentation Laboratory’s haemostatis testing equipment, ACL Top 500. >> 60/ MPN / JULY-AUGUST 2013

Moulding Microfluidics: FUNDAMENTALS In order to get an idea of the fundamental considerations when moulding microfluidics Medical Plastics News asked Axxicon, a Dutch maker of moulds for moulding microfluidic components, for a short technical guide to moulding microfluidics.

The company’s operations manager, Dirk Verhoeven, responded with the following information, highlighting the most important consideration to be a holistic approach to the entire production process, from beginning to end. << Dirk Verhoeven explains how Axxicon approaches mould design to ensure optical products are free from flowlines, specs or scratches. >> Dirk Verhoeven: A significant challenge is the commonly required combination of tight mechanical and optical specifications for microfluidic cartridges.

We start by making the microstructures, normally needed in various heights. The microstructures must have draft angles on the structure walls to enable demoulding. Structures can be produced directly in steel or in a master.

A nickel mould insert can be electroformed from such master. Which method is chosen depends to a great extent on the type of product to be moulded.

Moulding a stress free product with multilevel micro structures is challenging. To enable optical imaging, the birefringence, optical quality and thickness distribution of the product need to be within narrow specifications. No flowlines, specs or scratches are allowed.

The narrow specifications of the moulded substrates demand accuracy from the post moulding production steps as handling, cooling, metalising, biofunctionalisation, assembly and inspection. Low cost production requires fast cycle times which can be challenging in terms of using heat and mechanical forces.

The heat management of the moulding tool needs to be reliable. Conformal cooling of product forming parts is needed for good replication, for low cycle times and for flat, stressfree products.

The injection moulding process (machine) must be stable and show a low shot-to-shot variation. The demoulding, take out and further handling (cooling) is critical in terms of having no marks on the product and not having any warpage. When demoulding, or take out, is not done correctly the fluidic channels deform

because of shrinkage or incorrect take out. Burrs on the fluidic channels caused by demoulding are very unfavourable for the bonding process.

For the replication of microstructures (with unfavourable aspect ratios), for products with an unfavourable flow length to thickness ratio and/or for products with optical specification, an injection compression moulding (ICM) process is favourable. ICM means the resin is injected into the mould’s cavity when the mould is not completely closed. At the end of the flow path the moving mould half moves towards the fixed mould half with a certain force and speed. This reduces stress and provides a better thickness distribution. The alignment of both mould halves during this movement is critical for not having deformations on the micro features.

Various plastic grades can be used to injection mould microfluidic cartridges. The exact choice highly depends on what the application requires.

In deliberation with suppliers the right choice is made. The injection moulding process criteria—like clamping force, injection speeds/pressure, melt and mould temperatures—depend heavily on the material used and product moulded. Commonly used materials are PMMA, polycarbonate, cyclic olefin copolymer, cyclic olefin polymer and polystyrene.

Recommended further reading is a good book called Precision Injection Moulding, by Jehuda Greener and Reinhold Wimberger-Friedl, last updated in January 2006.

Holger Becker, founder and chief scientific officer at German developer and manufacturer of microfluidic systems microfluidic ChipShop, gave the following response.

“There is not “the” microfluidic device and, thus, not a simple recipe for successful moulding. Furthermore, it is not only the moulding which counts to make such a device work. Questions which should be answered are typcially: l Is my mould design such that there are no distortions or knit lines on critical areas like detection zones? l Did I choose the right material with respect to function of the device, for example protein adsorption, autofluorescence, cytotoxicity and so on? l Mould filling: The moulding parameters should be chosen to obtain an optimum mould filling, even if it means compromising on cycle time. Moulding usually is only a minor part of the value created in manufacturing a microfluidic device. l Low distortion of features during demoulding, especially along channel edges, otherwise bonding is compromised.

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COATINGS

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Medical Device Coatings Sales Growth, Antimicrobial Paraylene, Ultra Short Pulsed Laser Deposition, Pattern Coated Breathable PU Films and UK Surface Engineering Forum In June 2013, UK-based technology research and advisory company TechNavio published forecasts which predict that the global medical device coatings market will grow at a compound annual growth rate of just over 8.5% in 2012-16. The report says that growth is being fuelled by demand from manufacturers of products for minimally invasive surgeries. The forecasts are part of the report Global Medical Device Coatings Market 2012-2016.

SCS Launches Antimicrobial Parylene Coating Technology US supplier of Parylene conformal coating services, systems, and materials, Specialty Coating Systems (SCS), has developed SCS microResist antimicrobial Parylene coating technology.

According to the website conformal-coating.com, Parylene is a conformal protective polymer coating material utilised to uniformly protect a component on substrates such as plastic, metal, glass, paper, resin, ceramic, ferrite and silicon. The material conforms to virtually any shape, including sharp edges, crevices and points; or flat and exposed internal surfaces.

SCS says its new coating combines the benefits of Parylene with antimicrobial properties to effectively eliminate harmful microorganisms on coated devices and components.

SCS points out that the technology will help device manufacturers provide hospitals and healthcare facilities with better technology in the fight against healthcare associated infections (HAIs). It does this by offering manufacturers antimicrobial coating technology that effectively eliminates microorganisms.

Testing per JIS Z 2801, the standard method to test for antimicrobial activity, SCS microRESIST has reportedly demonstrated greater than 5 Log reduction after 24 hours on 14 common microorganisms, including E coli and Staphylococcus aureus. The coating technology has also been tested for long-term effectiveness against E coli, and achieved greater than 5 Log reduction.

SCS microRESIST technology can be applied to a variety of devices and applications where antimicrobial properties are critical during a product’s use.

<< Exopack’s pattern coating technology enables breathable films to be “effectively printed” with adhesives, opening up options for tailored moisture vapour transmission rates with dressings and other medical products. >>

Exopack Launches Tailored Breathable Pattern Coated PU Films with Pressure Sensitive Adhesives Exopack Advanced Coatings, a specialist manufacturer of coatings and medical components, has launched a range of breathable polyurethane films that are pattern coated with skin-friendly pressure sensitive adhesives.

The new products allow greater flexibility in the choice of adhesives as the breathability is derived from the voids in the layer of adhesive rather than from the adhesive itself. Special features include the ability to tailor the breathability (moisture vapour transmission rate—MVTR) to meet the customer’s specific requirements by changing the ratio of adhesive coated areas to non-adhesive coated areas on the polyurethane film. The range of adhesive properties available also increases as breathability is no longer restricted by the adhesive design. These new products are said to be ideal for use as components in silicone dressings.

Exopack Advanced Coatings says the new pattern coating technology enhances manufacturing capability and creates the potential to explore new polyurethane structures. It says the ability to “effectively print” any design from an array of dots to grids, or even text, opens up a wide range of possibilities for designing new dressings and other medical products. << The new machinery at Exopack’s facility in North Carolina allows the company to coat dual layers in a single coating or to coat both sides of a substrate. >>

Continued on page 64 JULY-AUGUST 2013 / MPN /63

COATINGS

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Continued from page 63 The company states that the addition of pattern coating technology emphasises its commitment as a global supplier for wound dressing components. The combination of expertise in polyurethane films and thin foams along with printing and adhesive coating makes Exopack Advanced Coatings unique in the marketplace.

In addition to the technical benefits of pattern coating there is also a positive environmental impact as the move away from 100% coating coverage can reduce the amount of adhesive required.

Exopack Advanced Coatings also provides contract coating. In February 2013 the company announced that it had brought new capacity on stream at its facility in North Carolina, USA, following investment of a multi head coater 1,650 mm (65 inches) wide and a drier 65.5 m (120 feet) long (see images on page 63). The capacity is available for medical customers as well as those in the electronics, renewable energy and security markets.

The investment gives the company the ability to coat dual layers in a single coating pass or to coat on both sides of a substrate, something it was not able to do before. The machinery has been installed in a newly built area of the factory.

The enhanced features of the new coater will permit access to more technically demanding applications and deliver a very efficient manufacturing process, the company says. The increased capacity also provides customers with a coating service solution that avoids the need for them to make substantial investment in establishing their own coating equipment. The initial products to be made will be high quality digital imaging media for a leading provider in this market place.

The new coater features a variety of direct slot coating and gravure coating methods for films, foils or papers. The drier has multiple zones and has the facility to differentially heat each side of the substrate. Combined with the ability to coat from a range of solvents, Expopack says the coater will become a valuable asset.

<< This cutting tool where the head has been nano-coated using Picodeon’s US PLD technology, thereby increasing the tool’s useful lifetime. >>

Picodeon Ultra-Short Pulsed Laser Deposition for Diamond-Like Coatings Finnish coating technology specialist Picodeon has developed a technique for depositing diamond-like films onto a wide range of substrates using its patented ultra-short pulsed laser deposition (US PLD) technology.

Diamond-like coatings create super hard surfaces (greater than 40 Gpa) with a low coefficient of friction and excellent coating adhesion. The US PLD deposition process uses a high laser pulse repetition rate and fan-shaped plasma bloom which reportedly enables high production rates and makes feasible the industrial coating of large surfaces at film thicknesses down to nano-scale.

Applications for diamond-like coatings range from machine tooling components through to wear components for medical, optical and sensor applications.

“Any components that need to have the highest possible hardness or wear-resistance can achieve improved lifecycles, greater heat and pressure resistance and/or improved performance with diamond-like coatings,” said Picodeon CEO Marko Mylläri. “Our US PLD deposition process can deliver the exact surface defined by our customers’ engineers because of the high level of tuning enabled by our process.”

Picodeon’s US PLD deposition is a cold ablation technology which works across a vast range of coating materials and substrates.

By adjusting processing parameters, the structure and properties of the coating can be tailored to the requirements of the application, even for nanostructure-scale surface coatings.

The US PLD technology delivers very high coating integrity without pinholes, giving improved reliability in applications where through-thickness defects may cause delamination of thin films and serious damage to components.

In addition to diamond-like coatings, US PLD technology, under the tradename Coldab, enables the deposition of carbon nitrides, carbon nitride composites containing PTFE or boron nitride (BN) as well as a wide range of other borides, oxides and precious metal thin films.

The high production rates and excellent coating qualities of Picodeon Coldab US PLD technology opens new possibilities and applications for pulsed laser deposition coatings. In selected areas it may even enable the development of exclusive coating methods.

Ceram Hosts Surface Modifications and Functional Coatings Forum UK based materials technology company Ceram held a free breakfast forum on surface modification and functional coatings at its headquarters in Stoke-on-Trent, UK, on Friday July 12, 2013.

The forum focused on how material surfaces contribute greatly to product performance and, using case studies, the benefits of surface modification were examined and solutions to a range of surface-related problems explored. How surface modifications can add value to products and help develop new ones was also discussed.

Keith Harrison, chairman, surface engineering division at The Institute of Materials, Minerals and Mining (IOM3), and Kevin Cooke, R&D technology centre manager at Teer Coatings, provided an independent view of how surfaces and coatings are applied in industry to improve performance and cost efficiency.

Alan Brown, Ceram’s director of development, said: “We were pleased that so many of our clients could join us on the day to discuss the advantages of modifying surfaces and introducing functional coatings. The feedback has been great; 86% of attendees agreed that the event was informative and valuable. We hope that the morning gave them some ideas on how surface modification could enhance their products and businesses.”

64/ MPN / JULY-AUGUST 2013

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EVENTS medical plastics diary | AUG-SEPT 2013

Conformal cooling and medical plastics seminars September 4-5, 2013 Toledo, Ohio, USA

Chemistry conference September 8-12, 2013 Indianapolis, Indiana, USA

Plastics conference—MiniTec September 9, 2013 Gurnee, Illinois, USA

Medical plastics conference September 17-18, 2013 Boston, USA

Medtech conference and trade show September 17-19, 2013 Philadelphia, USA

US medical device industry conference September 23-25, 2013 Washington DC, USA

Medical plastics trade show September 25-26, 2013 Birmingham, UK

Medical plastics conference October 8-9, 2013 Copenhagen, Denmark

European medical device industry conference Oct 9-11, 2013 Brussels, Belgium

Report from EuroTec 2013: A Focus on Medical Plastics and Polymers, By Austin Coffey A hugely successful Eurotec 2013 meeting was held in Lyon, France, on July 4-5, 2013. The European Medical Polymers Division of the Society of Plastics Engineers (SPE) had two full days of talks ranging from contact lens development to lactide polymers and their uses in state of the art high value applications within the medical industry.

Prof Jose Ramon Sarasua and Susana Petisco from the University of the Basque Country, Spain, outlined how polylactide bioabsorbable polymers can be engineered to have multiple applications using their shape memory characteristics. Dr Seán Lyons, centre manager for the Applied Polymer Technologies Centre, Ireland, identified techniques that can enable benchtop evaluation for radiation sterilisation compliant medical devices; thus realising a more cost effect method for material selection.

David Phelan and Shane McGrath, both from Waterford Institute of Technology, Ireland, gave fine papers in the area of contact lens development and active ingredient encapsulation. Joe Weber from Hampel Corp, USA, posed salient questions towards the power of proprietary products and the considerations of engaging with contract moulding companies— the development of collaborative and symbiotic relationships, where open innovation is now necessary to advance into higher value areas of technology.

Wireless active implantable medical devices are gaining increased traction from research bodies and is now realised to be critical to the

future of medical device development. Radoni Mario from the Polytechnique University of Marche, Italy, addressed the use of long term implantable polymers for encapsulation of electronic devices.

The medical plastics and polymers section of the EuroTec conference was very well attended. Feedback from the attendees was very positive in terms of the organisation of the event, location, and very high quality of papers presented. However, the biggest gain reported was the networking functions and contacts developed.

These days, in all industries, the key to success is strong knowledge networks. The SPE is home to more than 20,000 plastics professionals in more than 70 countries around the world. It is the “go to” resource for plastics technical information, business advice and knowledge transfer.

About the author: Dr Austin Coffey is a lecturer and PI of the Convergent Technologies Research Group at Waterford Institute of Technology. He is chairperson and councillor for the European Medical Polymers Division of the Society of Plastics Engineers. For further information and how to join this leading knowledge intensive network, visit www.4spe.org or contact acoffey@wit.ie. << Left to Right: Professor Jose Ramon Sarasua, University of the Basque Country, Dr Austin Coffey, chairperson of European Medical Polymers Division of the SPE, and Dr Seán Lyons, manager of Applied Polymer Technologies Centre, Ireland. >>