MPN EU Issue 23 by MPN Magazine

All Medical, All Plastics

MEDICAL PLASTICS news Small*

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Injection moulding Digital health Anti-microbials Plasma coating

The secret to Accumoldâ&#x20AC;&#x2122;s MICRO EXPERTISE

ISSUE 24

May-June 2015

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Celebrating 50 years of...

Partnerships. Since 1964, Phillips-Medisize has provided unparalleled knowledge, and expertise in advanced molding and assembly, to partner with its customers and provide ongoing quality and innovative solutions.

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CONTENTS May-June 2015, Issue 24

Regulars

Features

5 Comment Because we’re worth it . . . L’Oreal sets its sights on 3D printing

19 Doctor’s note Dr Steph Ball takes us to the heart of the digital health revoution

7 News analysis How infusing liquids into polymers makes a bacteriarepelling material

22 Growth chart Vancive Medical Technologies says where digital health is concerned, the proof is in the pudding

8 Digital spy Stay on top of the industry happenings 12 News profile An innovative device addresses maternal mortality rates 14 Speech therapy Rob Phillips, Accutronics, exercises his vocal chords 50 Beady eye How LiquiGlide is set to impact on the medical sector

25 Opportunity knocks Alan Davies, Philips explores the digital health boom 26 New York state of mind What this year’s MD&M East has to offer 28 Small world Aaron Johnson, Accumold, outlines what’s behind its 30 years of success

31 Shaping up Injection moulding expertise from Proto Labs, Ultrasion, Pentagon Plastics & Eastman 40 Dead cert Including Cikautxo Medical and PCC 44 On the surface Henniker’s approach for plasma treatment for PAD printing 46 Boning up PEEK-OPTIMA HA Enhanced could become the leading material for interbody fusion devices, says Invibio 48 Material assets Trinseo, explains how it’s meeting medical requirements with its resins

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All Medical, All Plastics

CREDITS

EDITOR’S

editor | lu rahman

comment

online editor | dave gray advertising | mandy o’brien art | sam hamlyn publisher | duncan wood

Medical Plastics News is available on free subscription to readers qualifying under the publisher’s terms of control. Those outside the criteria may subscribe at the following annual rates: UK: £80 Europe and rest of the world: £115 subscription enquiries to subscriptions@rapidnews.com

Medical Plastics News is published by: Rapid Life Sciences Ltd, Carlton House, Sandpiper Way, Chester Business Park, Chester, CH4 9QE T: +44(0)1244 680222 F: +44(0)1244 671074

© 2015 Rapid Life Sciences Ltd While every attempt has been made to ensure that the information contained within this publication is accurate the publisher accepts no liability for information published in error, or for views expressed. All rights for Medical Plastics News are reserved. Reproduction in whole or in part without prior written permission from the publisher is strictly prohibited.

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

Because we’re worth it

he opportunities that 3D printing has to offer the medical plastics sector are well documented. Since the technology first broke into the medical device sector offering printed vertebrae and meniscus, this area of expertise has burgeoned and we are increasingly seeing ways in which it can impact the supply chain and revolutionise medical care across the globe. The technology has of course expanded and its position in the medtech world as a disruptive innovation have been well and truly founded. We have witnessed the advent of 4D printing and the opportunities that holds for future devices and further advances but the recent news that this process is being used to print skin is highly exciting. Bio-engineering start-up Organovo has teamed with L’Oreal to 3D print human skin. The cosmetics firm currently grows skin samples from tissues that have been donated by plastic surgeon patients and media reports have questioned the thinking behind L’Oreal’s desire to produce skin in this way. Its most obvious use will be to aid testing of cosmetics products but that the technology is still in the very early stages.

product safety and performance, but the potential for where this new field of technology and research can take us is boundless.” Cosmetics aside, media coverage of 3D printing and L’Oreal’s involvement can only be good news for those working in this sector seeking funding to progress this area of expertise. Last year The Ross Tilley Burn Centre at Sunnybrook Health Sciences Centre in Toronto developed a skin printer in collaboration with researchers from the University of Toronto. Media reports at the time highlighted the impact such a piece of kit could have being used in under-developed countries or in military situations. Putting the technology to use is this way, as well as for wider-reaching severe burns and trauma patients highlights the way this technology can have far-reaching positive effects on the health and well-being of us all. Whether the printing carried out is polymer-based or utilising skin cells for this latest breakthrough, the life science field is yet again, pushing back the boundaries of possibility.

“

Media coverage of 3D printing and L’Oreal’s involvement can only be good news for those working in this sector

Guive Balooch, global vice president of L’Oreal’s Technology Incubator said: “Organovo has broken new ground with 3-D bioprinting, an area that complements L’Oreal’s pioneering work in the research and application of reconstructed skin for the past 30 years. Our partnership will not only bring about new advanced in vitro methods for evaluating WWW.MEDICALPLASTICSNEWS.COM

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NEWS ANALYSIS

Non-stick material joins portfolio OF SLIPPERY SURFACE TECHNOLOGIES Given the slip: Liquid–infused polymers absorb slippery lubricants like a sponge, rendering surfaces continuously slippery to protect against. Credit: Wyss Institute at Harvard University

ore than 80% of microbial infections in the human body are caused by a build–up of bacteria, according to the National Institutes of Health. Bacteria cells gain a foothold in the body by accumulating forming into adhesive colonies called Infusing liquids into and biofilms, which help them to thrive and polymers makes survive but cause infections and associated long lasting, self– life–threatening risks to their human hosts. replenishing material These biofilms commonly form on medical including those of mechanical that repels deadly surfaces heart valves, urinary catheters, intravenous bacterial build-up catheters, and implants. But a new study reported in the inaugural issue of ACS Biomaterials Science and Engineering demonstrates a powerful, long–lasting repellent surface technology that can be used with medical materials to prevent infections caused by biofilms. The new approach, which its inventors are calling ‘liquid– infused polymers’, joins an arsenal of slippery surface coatings that have been developed at Harvard’s Wyss Institute for Biologically Inspired Engineering and School of Engineering and Applied Sciences (SEAS). The technology leverages the molecular structure of polymers, which makes them highly capable of taking up and storing considerable volumes of lubricating liquids in their molecular structure, like sponges. This allows for absorption of a large reservoir of lubricant, which can then travel to the surface and render it continuously slippery and repellent — creating an environment that challenges bacteria’s ability to colonise. The team led by Joanna Aizenberg professor of chemistry and chemical biology in Harvard’s Faculty of Arts and Sciences, is designing various such liquid–infused polymer systems. For the current study, they have chosen a solid silicone polymer, the same kind already used in today’s medical tubing, saturated with a liquid, silicone oil. Both components are safe and non–toxic, and are already used in various medical devices and common products like cosmetics. “The solid silicone tubing is saturated with silicone oil, soaking it up into all of the tiny spaces in its molecular structure so that the two materials really become completely integrated into one,” said Caitlin Howell, postdoctoral researcher at the Wyss Institute and a co–author on the new findings. It’s this saturation process that makes the liquid–infused polymer so powerful and could result in a material able to withstand conventional sterilization methods and long–lasting use. This is due to the fact that the surface does not lose its

slipperiness over time — the silicone oil continuously diffuses to the surface, replenishing itself to replace any oil that is pulled away by liquids flowing against it, such as urine, blood, or gastro–intestinal fluids. To test the liquid–infused polymer’s effectiveness in biofilm prevention, the study’s lead author Noah MacCallum, an exchange undergraduate student at SEAS, exposed treated and untreated medical tubing to Pseudomonas aeruginosa, Escherichia coli, and Staphylococcus epidermidis, which are common pathogenic bacteria that form biofilms and are frequent culprits of urinary, tissue, and blood infections. The experiment confirmed that the liquid–infused polymer tubing greatly reduced bacterial adhesion and largely eliminated biofilm formation. As such, the new approach could be leveraged to prevent bacterial infections associated with the biofilm formation on catheters and other medical devices. This preventative aspect is crucial given that once biofilms develop they are remarkably resistant to removal, a problem that is compounded by rising antibiotic resistance in bacteria. “With widespread antibiotic resistance cropping up in many strains of infection–causing bacteria, developing out–of–the– box strategies to protect patients from bacterial biofilms has become a critical focus area for clinical researchers,” said Wyss Institute founding director Donald Ingber. “Liquid– infused polymers could be used to prevent biofilms from ever taking hold, potentially reducing rates of infection and therefore reducing dependence on antibiotic use.” Previously, Aizenberg and her team developed various other slippery surface technologies, including ‘SLIPS’, the Slippery Liquid–Infused Porous Surfaces technology introduced in 2011 that can repel virtually any liquid or solid material and offer solutions to a range of applications.

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The new approach could be leveraged to prevent bacterial infections associated with the biofilm formation on catheters and other medical devices.

SLIPS inspired the invention of a different type of slippery surface using tethered– liquid perfluorocarbons, known as TLP coating, developed in collaboration between Aizenberg and Ingber in 2014. TLP coating uses FDA–approved materials to prevent bacterial build–up and sepsis from occurring due to the use of medical implants or devices, while eliminating the need for conventional and side effect–prone anticoagulant drugs.

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DIGITAL

spy

MEDICAL MATERIALS UPDATE

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APPY TALKING BEING ABLE TO ACCESS THE LATEST TECHNOLOGY CAN MAKE A REAL DIFFERENCE TO THE WAY A BUSINESS OPERATES. THIS ISSUE MPN SELECTS SOME OF THE BEST BUSINESS APPS ON THE MARKET. Buildfire This app can turn you into your own digital designer, allowing you to build an app quickly and easily – perfect for cashconscious start-ups. Google Drive Great for working on the road - wave sayonara to tatty folders full of documents. Google Drive joins a host of other drive storage solutions, but offers 15GB of space for free - which is more competitive than some contenders. Splashtop Ideal for anyone that needs to access their desktop on the move, Splashtop means you can get to your laptop via any mobile device. Abbyy card reader In the digital era, carting business cards around does seem a little dated. Abbyy scans and uploads business cards leaving your pockets free and uncluttered. Nutcache Offering a host of function, Nutcache has hit the spot with many company owners allowing invoicing, expenses and time-tracking for employees.

DIGITAL SPY

AMI conference

GIVES MEDICAL MATERIALS UPDATE!

MI’s Medical Grade Polymers 2015 conference on plastics and elastomer materials for medical devices, drug delivery, implants and surgical instruments, takes place September 15-16, 2015, Boston. Medical Grade Polymers 2015 kicks off with a review by Mark Moyer (formerly at Smith & Nephew, now with the Center for Advanced Medical Learning at USF), of how to innovate, sort out the regulatory compliance and get a new product into the healthcare market as quickly as possible. The moulder, Cequr, will provide an outline of manufacturing trends and market challenges for innovation. The scale of the legal liabilities in this industry has deterred some of the larger materials companies

Other highlights will include Raumedic who will focus on the design requirements and manufacturability of medical tubing for stent and balloon delivery systems, while Medical Grade Mack Molding Polymers 2015 has discovered several ways to 15-16 Sept cut production costs and UFP Technologies who produce a number of medical foams and films used in wound care.

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Generation XT

Meliflex XT tubing grades have been used in numerous applications for years. Recently, the company introduced its XT generation that has been well-received in the market for its enhanced properties and improved costs. It has also been tested and proven to pass ISO 10993-4 haemolysis testing.

also explored for various blood contact applications with good results and therefore, we decided to certify these to ISO 10993-4 to support our customers in their qualification work,” he added. Meliflex XT grades are available in a range of shore durometer hardness ranging from Shore 50A-95A and withstand sterilization at 121 C, EtO, gamma and E-beam.

“We have had a strong interest in our newest Meliflex XT grades not only from Europe, but also from USA and Asia,” said Jesper Laursen, business director, Melitek. “Materials are now

from participating fully and the law firm Keller and Heckman will give a critical outline of the key issues for material suppliers in the medical marketplace.

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DIGITAL SPY

www.cimedtech.com

talking

POINT

MAIN STORY

Tekni-Plex

— new lamination line

ekni-Films, a division of Tekni-Plex, has a new laminated barrier films line in Ohio. Production is scheduled to begin mid-summer, with additional capabilities in the planning stages. Initially, the line will be producing high barrier, polyvinyl chloride/Aclar laminations used to create blisters for pharmaceutical and medical device packaging applications. Additional material types are expected to follow. Tekni-Films’ new capability includes high-speed manufacturing equipment, vision systems and other quality control upgrades. These conform to cGMP and ISO standards which will help customers meet their stringent productivity and regulatory requirements.

The new production capability will complement the company’s global network of existing laminated barrier film manufacturing capabilities located in Erembodegem, Belgium and Buenos Aires, Argentina. “This is just another example of how TekniPlex takes a leadership role in supporting the needs of its customers. By combining our global manufacturing footprint with the latest technology, we create a seamless supply source for both our multinational pharmaceutical customers, as well as those with more regional requirements,” said David Andrulonis, vice president and general manager, Tekni-Plex Films.

another dimension Breakthrough technology for layerless 3D printing How does it work? Carbon3D is offering an innovative approach to polymer-based 3D printing that promises to advance the industry beyond basic prototyping to 3D manufacturing. Why is it so significant? Carbon3D’s CLIP technology raises the bar in 3D printing in three ways: It has a game-changing speed which is 25-100 times faster than conventional 3D printing; Commercial quality – produces objects with consistent mechanical properties; Material choice – enables a range of polymeric materials.

TWITTER WATCH @DeloitteHealth Research from the Deloitte Center for Health Solutions We liked… #Medtech companies should consider developing end-to-end solutions @MDTinnovation Medtronic Eureka, the ‘ideas portal’ from Medtronic We liked… Have you had an idea about innovating #medicaldevices? Then get in touch for expert guidance. @TuttSterilizers Sterilization and infection control blogs from Tuttnauer Autoclaves We liked… Plastics grow as materials of choice for medical devices. How will it affect sterilisation methods? @EPPM_Magazine MPN’s sister title in the European polymerverse We liked… Eureka Series: Could polymer innovation transform #medical implant tech?

SOCIAL SPY

My top tweets NELIPAK PICKS ITS FAVOURITE TWEETS FOR MPN IBM announces deals with Apple, Johnson And Johnson & Medtronic for #IBMWatsonHealth http://onforb. es/1FOrRaI #JNJ’s Martin Madden on how innovation is the key to addressing evolving needs of patients http://bit.ly/1CKnQkj Ian Read: How do we turn the best science into new medicines that reach patients faster? #Cures2015 http:// on.pfizer.com/1EzjxwP Top 5 trends in the non fusion spine market http://ht.ly/Ls7sw Infographic: Examining Analytics in Healthcare http://ht.ly/LfWK9 WWW.MEDICALPLASTICSNEWS.COM

What they said “Current 3D printing technology has failed to deliver on its promise to revolutionise manufacturing,” said Dr Joseph DeSimone, ceo and co-founder, Carbon3D. “Our CLIP technology offers the game-changing speed, consistent mechanical properties and choice of materials required for complex commercial quality parts.” How CLIP works Carbon3D’s layerless continuous liquid interface production technology (CLIP) rapidly transforms 3D models into physical objects. By carefully balancing the interaction of UV light, which triggers photo polymerisation and oxygen, which inhibits the reaction, CLIP grows objects from a pool of resin at speeds 25100 times faster than traditional 3D printing. At the heart of the CLIP process is a special window that is transparent to light and permeable to oxygen, much like a contact lens. By controlling the oxygen flux through the window, CLIP creates a ‘dead zone’ in the resin pool just tens of microns thick where photopolymerisation cannot occur. As a series of crosssectional images of a 3D model is played like a movie into the resin pool from underneath, the physical object emerges continuously from just above the dead zone. Much more like injection-moulded parts, CLIP produces consistent and predictable mechanical properties, smooth on the outside and solid on the inside.

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NEWS PROFILE

Video measurement

HELPS REDUCE CATHETER-BASED INFECTION

ith catheter-associated urinary tract infections (CAUTI) being the most common hospital-acquired infection and shown to be on the rise in every care unit type in the US, researchers are constantly working to address the problem through the Catheter-based coating of catheters with biocides. However, infection can until now, results have been disappointing be reduced by with few coated catheters reaching the impregnating the market, and those showing poor clinical results.

devices with antimicrobial properties and testing their mechanical properties using non-contact video measurement

Researchers at Nottingham University have recently published a paper in the Journal of Controlled Release discussing the development of new catheters impregnated with antimicrobial combinations that would reduce CAUTI, especially for patients with long-term catheterisation.

As part of the development process, the mechanical properties of the catheter balloon needed to be tested. This is because the inflatable retention balloon is an obvious site of susceptibility for any deterioration in mechanical properties. Also, the catheter is subject to tensile force during insertion and removal. Nottingham Universities’ researchers adapted tests from ASTM F623 99 and BSEN1616: 1997 to study how the mechanical properties were affected by impregnating the catheters with the antimicrobials.

Susceptibility of catheters to infection The most commonly used catheter comprises two separate lumens that run down its length. One lumen is open at both ends to allow urine to drain out into a collection bag. The other lumen has a valve on the outside end and connects to a balloon at the end. The balloon is inflated with sterile water when it lies inside the bladder to stop it from slipping out. As in other devices, CAUTI pathogens are able to attach to the catheter material, usually silicone rubber, and develop biofilms. The second most common pathogen Proteus mirabilis is particularly problematic as due to associated biomineralization, it can block the catheter lumen causing obstruction and risking kidney infection and septicaemia. In order to address this problem, one approach has been to attach active biocides to the biomaterial surfaces. However, these antimicrobial coatings can be either quickly depleted by the urine flow or obliterated by a host protein conditioning film.

Researchers at Nottingham University have taken a fresh look at the problem that involved impregnating the catheter material post –manufacture with antimicrobials and looking at effect of processing on mechanical properties, particularly of the important retention balloon.

Testing the mechanical properties It is important that any post-manufacture processing does not damage the biomaterial and the inflatable retention balloon is an obvious site of susceptibility for any deterioration in mechanical properties. In addition, the catheter itself is subject to tensile force during insertion and removal. Mechanical performance of catheter shafts was assessed using a Universal Test Machine with a 5 kN load cell connected to high resolution, non-contact video extensometer from Imetrum. The catheter tubing was connected to the materials testing machine and the catheters were clamped to expose a 5cm length along the mid-section of the catheter and coated metal targets were applied 3cm apart to allow for tracking by Imetrum’s video extensometer. A force was applied at a rate of 100mm/min and was continued until either the apparatus reached its maximum length limit or until catheter breakage occurred. The Imetrum system comprised a controller with the sophisticated Video Gauge software installed together a high-resolution digital video camera. Built around patented algorithms and using pattern recognition and sub-pixel interpolation to measure the exact displacements of selected points in an image, the coated metal targets were tracked in real time, outputting measurements frame-by-frame until the end of the test when the catheters broke. All tests were conducted at room temperature and in all cases three replicates of each analysis were performed. From the resultant relationship between the stress and strain, the load (N), ultimate tensile strength (MPa), elongation at break (mm) and modulus (MPa) determined at 280–320% elongation were calculated. The results showed that neither the process itself nor the presence of the antimicrobials affects the mechanical properties of the material. Impregnating the catheter and balloon with antimicrobial agents caused no adverse effects to the mechanical performance.

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NEWS PROFILE

Innovative device

ADDRESSES MATERNAL MORTALITY RATES Life saver: Cambridge Design Partnership has developed a novel Uterine Balloon Tamponade (UBT) to help life threatening situations experienced by mothers after childbirth. Photo Lucian Coman | Dreamstime.com

nnovative technology and design partner Cambridge Design Partnership has developed a novel Uterine Balloon Tamponade (UBT). This medical device is designed to help healthcare workers respond to life threatening situations experienced by mothers after childbirth, specifically in low resource settings.

Postpartum Haemorrhage (PPH) is the term given to severe bleeding within 24 hours of childbirth. It is the leading single cause of maternal mortality and is thought to be responsible for approximately 57,000 deaths each year worldwide, nearly all of which occur in developing regions1. With the right kind of equipment deployed at the right time, PPH can be treated very effectively. In 2012, the World Health Organization (WHO) updated its recommendations to include the UBT as a treatment for PPH when uterotonic drugs are ineffective or unavailable. Commercially available UBTs can cost as much as $200 each and need to be carefully inserted in theatre by trained clinicians. These factors prohibit their use in low resource areas, where currently a makeshift alternative assembled by tying a condom to a urinary catheter – the ‘condom

Postpartum Haemorrhage (PPH) is the leading cause of maternal mortality and is thought to be responsible for approximately 57,000 deaths each year worldwide

catheter’ – is being trialled. Whilst this device is certainly cheaper, it still requires careful assembly, significant training and skill to be successful. The new UBT designed by Cambridge Design Partnership bridges the gap between the more expensive versions used in the West and the ‘condom catheter’. Its novel design combines features that make it intuitive and effective to use, to enable patient safety even in the hands of less experienced users – as well as ensuring cost effectiveness for manufacture.

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This medical device is designed to help healthcare workers respond to life threatening situations

Lucy Sheldon, human centred design specialist, Cambridge Design Partnership said: “To be effective in low resource settings, medical products such as UBTs must be affordable and available; optimized for the intended conditions of distribution, storage, and use. To meet these needs we applied a human centred approach to the innovation process - combining expertise in human factors, risk management and interaction design - to the development of our device. Our aim was to maximise usability in the hands of minimally trained birth assistants and lower the overall costs of the intervention, through reducing the medical professionals, equipment and training required to safely and effectively use the device to ultimately save lives.” Cambridge Design Partnership is now actively looking for partners and funding to continue the development of its UBT concept, to identify and test progressive training and deployment strategies potentially utilising mobile phones and to quantify the potential of a ‘reduced training’ UBT intervention. 1 Ref. Say L et al. Global causes of maternal death 2014

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ADVERTORIAL

Play it safe: SCHOTT PRESENTS NEW POLYMER PREFILLABLE SYRINGE FOR SENSITIVE DRUGS

SCHOTT introduced a new polymer prefillable syringe designed to improve the safety and stability of sensitive drugs (SD). As pharma companies are looking for safe and reliable packaging solutions, the new product named SCHOTT TopPac SD offers new features for a reduced E&L (extractables and leachables) profile. For the first time, these new features were combined with the proven benefits of the SCHOTT TopPac polymer syringe system.

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house sensitive drugs, the PFS also retains the traditional advantages of the TopPac product line, including glass-like transparency, an integrated Luer Lock system, standardized tuband-nest offerings, and compatibility with needleless IV connectors.

SCHOTT TopPac SD provides pharmaceutical manufacturers a trusted solution for their sensitive drugs and supports patient safety

Through specific component selection and an optimized processing method, SCHOTT TopPac SD offers a significantly reduced level of impurities, decreasing the chance of drug/ container interaction. The syringe features an inert COC barrel (cyclic olefin copolymer) that releases no ions or heavy metals, and reduces the chances of a chemical interaction with sensitive drugs. Additionally, the PFS (prefilled syringe) was developed with pure elastomer components in order to reduce the E&L profile. Cross-linked silicone for barrel lubrication reduces the amount of subvisible particles with optimal functionality. Finally, the new syringes are sterilized with an ETO (Ethylene Oxide) sterilization method, rather than irradiation, to further reduce the E&L profile. While the new product features a number of components that were specially designed to

“As more sensitive drugs enter the market, the need for highquality, reliable packaging becomes increasingly important,” said AnilKumar Busimi, Head of Global Product Management Syringes Business. “SCHOTT TopPac SD provides pharmaceutical manufacturers a trusted solution for their sensitive drugs and supports patient safety.

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SPEECH THERAPY

VOCAL

exercise

Who are you and what do you do?

I’m Rob Phillips, managing director of Accutronics. The company is an independent battery business serving specialist OEMs in the medical device market, specialising in developing and manufacturing high-performance smart battery and charger systems. From small credit-card sized batteries for use in wearable medical devices to intelligent power vaults for use in highpower, high-discharge environments in hospitals, we make them all. Some of our technical achievements include class leading protection circuits that prevent batteries from over charging, over discharging and overheating, as well as algorithmic security that prevents fake batteries from being used in life-critical medical applications.

How would you sum up your company?

Accutronics enables forward-thinking MedTech companies to create and deliver the next generation of portable medical devices.

Name a business achievement you are most proud of? Having grown the company from a startup in 2009, during one of the worst recessions in history, Accutronics is now a first-choice partner for some of the world’s leading MedTech OEMs.

What excites you about this industry?

The environment of constant innovation is enthralling. Knowing that all these efforts are aimed at improving people’s lives and the quality of their health makes this a very rewarding industry to be in. We’ve identified several key trends in the MedTech sector: battery energy densities are rising, as equipment is becoming mobile; security is a big concern, especially when it comes to counterfeit batteries; the demand for premium medical devices in the Asian MedTech sector is growing rapidly; new innovations such as fast and wireless charging are on the rise; and finally, the development of antimicrobial polymers and surfaces is providing an extra line of defence against superbugs.

Where do you predict industry growth will come from over the next 12 months? The BRIC countries are recognised as being economies with the fastest growing infrastructure in areas such as health service assets, transportation and specifically portable medical devices, which will deliver increased flexibility and value to healthcare users. This is where we expect most of the growth to come from.

Which medical plastic device do you wish you had invented and why?

The plastic syringe, as it’s one of the most versatile products. It’s more robust and lighter than glass. It’s much cheaper to manufacture, there must have been millions manufactured already.

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SPEECH THERAPY

ISOLATION UNIT

he increased complexity of medical device setups is causing concern in the medical industry. As more and more healthcare professionals use a variety of electrical equipment as part of their diagnosis and measurement regime, Steve Hughes, REO UK, there is a knock-on effect on the explains the importance stability of the mains power supply.

of electrical isolation and good product design in medical devices

Here, Notepads have been replaced with iPads, mechanical beds with electrically adjustable beds and traditional film imaging has been substituted with the latest digital picture archiving and communication system (PACS). Add to this other innovations, such as endoscopy cameras and new dental systems, and the mains power supply certainly has a lot to deal with. The increasing electrification of devices creates problems on the mains power supply. AC to DC power conversion by the device’s power supply introduces voltage distortion, current harmonics, electrostatic discharge, power surges and electromagnetic interference (EMI) into the supply. These power quality problems can affect the calibration and sensitivity of diagnostic devices used by doctors and healthcare professionals. Erroneous test results can result in misdiagnosis and potentially harmful treatment plans for patients. European legislation has focused on tackling this issue by introducing minimum requirements for the electrical isolation of various medical equipment. The IEC 60601-1 medical device standards govern the essential performance, basic safety and design requirements for new medical devices. The directives classify devices into three areas based on how closely they are used to the patient’s body. Type B devices operate within a six foot vicinity of the patient without bodily contact. Type BF makes physical contact

with the body and Type CF makes physical contact with the heart. Each of the categories outlines the level of isolation, insulation, creepage, clearance and leakage allowed. Most large equipment used in a clinical setting, such as magnetic resonance imaging (MRI) machines, anaesthesia units and ventilators, contain an embedded transformer or are disconnected entirely from the mains by using battery packs. However, devices in patient environments don’t usually contain a transformer and it’s not always costeffective, practical or necessary to use battery packs. It’s for this reason that we developed the Reomed isolation transformer which aims to provide safe galvanic separation between primary and secondary circuits, double and strengthened isolation, a very low leakage current and strict air and leakage clearances. For users looking to isolate medical devices in patient environments, the Reomed has been designed to offer an easy way to meet European electrical isolation standards by simply retrofitting the transformer into an existing setup. However, it’s important to remember that the legislation also goes further in stipulating requirements for ergonomic design. In the USA the Food and Drug Administration (FDA) recalled nearly 200 products that had failed due to electrical problems, mechanical faults due to poor design, bacterial contamination during manufacture and device software issues.

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As healthcare professionals use a variety of electrical equipment there is a knock-on effect on the stability of the mains power supply.

At REO we’ve found that sustainable design is only achieved through a consultative process between doctors, regulatory bodies, original equipment manufacturers (OEMs) and patients. By undertaking thorough design testing, manufacturing controls, and post installation servicing, OEMs can hope to provide the successful wave of next generation medical devices.

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CRITICAL CARE. Thatâ&#x20AC;&#x2122;s what we put into every package.

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DIGITAL HEALTH

Doctor’s note “He’s cold, clammy, his blood pressure is through the floor Sister, where the HELL has that observations chart got to?”

The life science sector is awash with talk of the digital health revolution. But what does it mean for the medical device manufacturer? Dr Steph Ball outlines the way in which digital health is bringing about change for both doctors and patients to help inspire manufacturers to push forward with digital health innovation

“I keep telling you, doc, we’re using e-obs now! Log in to your iPhone!” “Ah! Yes! Marvellous! Now where did I put that thing ” After patting myself down in a futile and somewhat sheepish fashion I eventually located my work phone languishing in the office. Encased in a cover that can only be described as a smartphone’s answer to a lead-lined chastity belt (in case we drop it - 400 to replace), this chunky iPhone 5S is the new lifeline of our hospital’s outof-hours care. A few clicks and swipes and all the information I needed about my patient’s progress was right there in front of me.

I qualified as a doctor back in 2009 and over the past five years have worked in many different hospitals with similar technology. Broadly speaking, all junior doctors are equipped with a pager or ‘bleep’ – that’s right, that piece of tech that became obsolete everywhere beyond

the realms of the NHS in about 1997. In an age of mobile technology, this seems bizarre to me. Mind you, as antiquated as the system is, there are several perks. For example I was able to change the settings on my netpager to play ‘Mary Had a Little Lamb’ every time it went off (needless to say, I now have a Pavlov-esque shudder every time I hear that song, but the initial novelty was not lost on me). On the whole, too, despite the dream of moving towards a ‘paperless’ system, the NHS is clogged with paperwork. We write in thick, heavy sets of notes, and clipped to the end of most patients’ beds, along with reams of care plans, are their observation charts. For a doctor, this information is the cardinal marker of a patient’s progress. Of course we ask On the whole, too, questions, we examine, we diagnose, despite the dream but if a patient has a racing pulse, of moving towards a a raging fever or a crashing blood ‘paperless’ system, pressure, we need to know that above the NHS is clogged all else. And we need to know fast.

“

with paperwork.

This is where Nottingham University Hospitals NHS trust is different. I began working at the colossal Queens Medical Centre in 2013 and immediately noticed a move towards digital change. It’s true that for my day to day workings

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DIGITAL HEALTH

I still carry a pager and the cardiac arrest call is still transmitted through a special ‘crash bleep’ (this one speaks to you, and I wouldn’t advocate this system changing any time soon – it works well.) But out of hours and at weekends, things are done very differently. Nottingham is one of eight NHS trusts (others include Nottingham Leicester, Portsmouth and Hull) Hospitals have who work alongside Nervecentre been relying (nervecentresoftware.com) which provides us with modern software on smartphone that is far more Xbox than Ataris. technology Nottingham Hospitals have been since 2011 but last relying on smartphone technology year made the switch since 2011 but last year made the switch from Blackberry to iPhone from Blackberry to and with this, updated paper iPhone observation charts to their digital hitech counterparts.

“

To explain how it works, my typical out of hours shift will start at 5pm. I leave my day job and head to a central Hospital@Night hub on the ground floor, where a nurse co-ordinator hands out an iPhone to all the out-of-hours staff. We all have unique logins meaning our activities are confidential should the phone be misplaced, yet internally traceable and auditable. The phones are connected through the hospital wi-fi and allow us remote access to a lot of information – I can be anywhere within the hospital and view anyone’s observations, alongside a brief summary of the patients’ ailments. I can scroll through a ward full in seconds, and see if anybody is particularly unwell (deranged observations flash up red, middling in amber, and normal in green.) Should a nurse find a job for me to do, she or he can type what they want onto the Nervecentre request page, it will get sent to the hub, vetted by the co-ordinator, and sent to my iPhone’s ‘jobs list’ in a matter of minutes. It saves them the hassle of paging me,

and saves me the hassle of being incessantly inundated with bleeps – jobs seem much less threatening if automatically compiled into a neat, prioritised. I can see who else is working by accessing a directory of logged on phones. I can contact my seniors, text the co-ordinators, and tick-off my jobs at the click of a button. If someone needs me urgently, they can call me directly rather than wait for me to flap around and find the nearest landline to respond to my bleep. How novel a concept indeed! Of course, there are bound to be teething problems. At least with a pager, I could ring the ward and discuss the request person-toperson, assess urgency and if able, deliver phone advice. With my smartphone I can feel less in control and more dictated to in terms of workload. Some jobs are graded ‘urgent’ when they are not, and some triage as ‘low priority’ when a patient is actually pretty unwell. No bit of kit can substitute for good clinical judgement and my smartphone is no exception. Also, in all honesty, reviewing an observations trend on a tiny 3.5 x 4 ins screen is slightly more of a ‘head-scratching’ experience than on a beautifully filled in written chart. If anyone thinks we can use them to have a jolly – you’re wrong. All fun stuff including facebook, Candy With my smartphone Crush (and everyone’s guilty pleasure, the Mail online gossip column) are I can feel less in blocked, as they are on hospital control and more computers. But these criticisms are dictated to in terms minor and bred by a secret innate, of workload. yet easily overcome resistance to change, which you’ll find amongst many healthcare professionals, including me. Fundamentally, however, it is unquestionable that as healthcare as a whole makes awe-inspiring developments, so to must our communication systems, and the use digital media is a sound way to advance.

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“

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DIGITAL HEALTH

Growth chart D

igital health is changing the way healthcare is delivered, accessed and consumed. Wellness trackers, wearable medical devices, related analytical software and mobile apps According to Deepak are forever changing the face Prakash, Vancive of healthcare.

Medical Technologies where digital health is concerned, the proof will be in the pudding and its growth will be intricately linked to evidence of its clinical effectiveness

Richard Bloomfield, director of mobile technology strategy and assistant professor at Duke University, sums it up well in his blog, The Mobile Doc: “Technology has never had so much promise for the improvement of medical care as it does right now.”

Yet amid all of the excitement, there is the reality that paradigm shifts don’t happen overnight. For the healthcare industry, in particular, change requires proven, repeatable, documented proof that new solutions are equal to or better than the current care standards.

Heady growth Projections abound regarding digital health’s growth. Statistics show how that growth aligns with wearable electronics expansion. IDTechEx predicts that the wearable electronics business will grow from $20 billion this year to almost $70 billion in 2025. Healthcare, which “merges medical, fitness and wellness”, will be the dominant sector in this growth, the research firm says. Funding is flowing into digital health development as investors recognize the possibility for profitable returns. In the report, “Health Wearables: Early Days”, PwC cites an IDC research finding that digital health start-ups raised $2.3 billion by mid-2014, more than the total raised for the full year 2013. Of this amount, $200 million funded digital medical device developments, the report says. The PwC report also highlighted a challenge for continued growth: consumer acceptance. In a survey of 1,000 US

consumers, PwC found that 38% were “very/somewhat willing” to purchase a wellness tracker for $100. Only 9%were willing to pay more. However, 68% said they would be willing to use trackers offered free through their employer. In this scenario, consumers indicated they would share their tracker data anonymously in return for insurance premium discounts.

Methodical progress For medical device developers, healthcare provider and insurer acceptance of digital health applications also is very important. For digital solutions to take hold, they must demonstrate compelling evidence that they are effective. This will require rigorous testing and trials. Some digital health solution providers already are engaged in this process, and the healthcare industry is taking note of the results. For example, the Metria IH1 Lifestyle Assessment System was used in a study by a leading hospital and research institution to monitor activity levels of patients recovering from strokes, amputations and spinal cord injuries. In addition, the US Center for Disease Control and Prevention has added “virtual or online programs” as a category for its Diabetes Prevention Recognition Program (DPRP). This opens the door for virtual programs to be recognized for using an evidence-based approach to treating diabetes. They will be held to the same standard as programs physically For digital solutions based at healthcare institutions. It’s an to take hold, they important step because it acknowledges must demonstrate that new paradigms are needed to combat compelling evidence major chronic diseases and that lifestyle interventions delivered remotely and digitally that they are effective. are effective.

“

Some digital health applications are changing the very nature and pace of evidence-based research. The Wall Street Journal recently published an article on the rise of new disease-related apps for clinical trials. The article described how in less than two months, about 60,000 patients enrolled in five studies using various apps built with Apple’s ResearchKit. The trials’ scientists are “hoping to learn more about the long-term effects of chronic disease on participants, including whether the use of a smartphone might help individual patients deal more effectively with their symptoms”, according to the article. In the coming months and years, many more medical studies and clinical trials will focus on digital health. This research will enable digital health solution providers to prove their worth and address shortcomings, both of which will be essential to progress.

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DIGITAL HEALTH

y t i n u t r o Opp KNOCKS

o one will deny that the expansion of digital technology has grown rapidly in the last few years, nowhere more so than in the provision of health care. Wearable technology, telehealth services and the innovative use of 3D and 4D printing possibilities There’s a major have all started making a positive transformation taking impact on people’s health and wellbeing. Philips is also taking place in the way we an active role in transforming interact with and use healthcare through innovation and healthcare technology, improved service design, and our and digital devices are experience in creating products for people across the whole leading the way. Alan health continuum has highlighted Davies, director of some interesting opportunities for home healthcare for UK increased collaboration within this transformative period.

and Ireland, Philips explores this boom and its opportunities

A core impact of digital technology is that it makes data sharing quicker and easier. This is opening up opportunities for service and solution providers to become active partners with their clients not only in providing technical aspects of care service, but by being involved at a strategic level too. This is increasingly pertinent as the NHS Five Year Forward report highlights. It acknowledges that a growing population is putting increased pressure on public budgets but this can be alleviated by integrating intelligent technology widely into the healthcare system. Philips is committed to supporting this and, importantly, innovating collaboratively do drive up patient care. A good example of how collaboration has enabled technology to spur innovation on a large scale is our partnership with the Liverpool Clinical Commissioning Group (CCG). In conjunction with the Liverpool CCG and a number of other organisations, industry and clinical service expertise came together and were able to explore new, innovative ways to use technology to help assist people with mobility difficulties. Public and private partners explored all aspects of assistive technology, from assessing how homes can be made easier to navigate to improving the ease with which GP appointments are made and patient data stored. Dr Cees Van Berkel, principal scientist at Philips Research UK, summed up how important it was to collaborate when stating: “Telehealth has traditionally been seen as a patient monitoring tool following a hospital discharge, but by working in true

collaboration with partners and GPs, we’ve managed to look at ways where telehealth can help in the primary care setting. Collaboration was essential to gaining the insights required and ensuring that what was suggested didn’t impede on the GPs’ roles and responsibilities but instead brought them into the mix from day one. The resulting ideas and services have consequently been widely championed in the region .” This is a partnership model that Philips sees as the future and a key opportunity for providers in the healthcare industry. Product and strategic collaboration can help amplify each partner’s efforts. It’s not always a case of reinventing the wheel but working well, together. Crucially, digital healthcare is not only making it easier for providers to do this, but for clinicians too. Telehealth itself is a great example of how digital technology is sharing information quickly and widely to support clinicians. Philips has been collaborating with the Radbound university medical centre, Holland, to look at how to better monitor COPD patients in the community. By working with Radbound and its patients, we’ve explored the possibility of real-time, 24/7 monitoring and improved information from which clinicians can make decisions on patient care programmes. An outpatient with breathing difficulties caused by their COPD will be hesitant to regularly travel between home and hospital clinics for tests, but by providing a small monitor, worn around the neck, we’ve removed that burden. The data is transmitted constantly and any abnormal readings trigger a real-time alert to the supervising clinician. So digital health is helping clinicians provide better care and helping providers work in a far more integrated fashion with professionals and patients. Digital health is also making devices much smaller and more flexible. This makes them more appealing, increasing the demand. Within healthcare this demand is driven not only by fitness fans who can wear pedometers around their wrist also the less mobile or those living with chronic diseases, who can wear their health monitors discretely around their wrist or neck. This provides an innovation opportunity as changing health needs drive a need to create new support systems. These examples are just a few that highlight how collaboration has brought improved results, both to providers and, most importantly, to patients. If there’s a key takeaway to those, it would be to highlight that collaboration is not only desirable, it’s essential.

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MD&M EAST

New York

state of mind F

or over 30 years, east coast medtech professionals have gathered at MD&M East to see first-hand the latest innovations in medical device design and to learn and network with the leading minds in the industry. MD&M East returns this This year’s MD&M June 9-11, 2015, at the Jacob K Javits East will take place Convention Center in New York City for June 9-11, 2015 at three full days of education, networking, and business development

the Jacob K. Javits Convention Center • • • • • •

Returning and expanded features at MD&M East to include: Hundreds of top suppliers demonstrating the latest medical device innovations World-class experts sharing their knowledge on today’s hottest topics at the MD&M East Conference The Medical Design Excellence Awards (MDEA) recognize the most significant advances in medical product design and engineering Exclusive networking opportunities to connect with likeminded professionals at Speed Networking Free educational sessions right on the show floor at the Centre Stage & Tech Theatre Behind-the-scenes looks at the latest innovations on the show floor with free Innovation Tours

Gain insight at the conference The MD&M East 2015 conference will offer interactive, hands-on sessions and panel discussions led by a faculty of 50+ industry thought leaders. This year’s education program will cover the hottest topics in medtech organized into these tracks:

• Design Innovation for medical devices • Mastering process validation training • MD&M technology corner (sensors, energy harvesting, flexible electronics and more)

• 3D printing for medical device design & manufacturing LEONARD ZHUKOVSKY / SHUTTERSTOCK.COM

Attendees of MD&M East will also have access to other three day events on the same show floor covering topics including packaging (EastPack), industrial design and manufacturing (Atlantic Design & Manufacturing), plastics (PLASTEC East), automation and robotics (ATX East), quality assurance and management (Quality Expo East), and health and beauty products and brand development (HBA Global). In addition, attendees will also have access to the pharmaceuticals packaging show (Pharmapack North America) held at the Javits’ River Pavilion June 9-10.

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COVER STORY

SMALL

world MPN: Accumold celebrates 30 years - what do you think is the secret to the company’s success? From its humble beginnings in a rented garage 30 years ago, Accumold is now a key player in the micromoulding sector. Aaron Johnson, talks to MPN about the company’s major achievements, the reasons behind its staying power and what it has in store for the future

AJ: It sounds a cliché but the secret to our success is our people. Accumold was founded on an innovative spirit that still thrives today. Innovation is not something you can buy nor is it a switch you can turn on. Over the years our team has carried the internal drive to create, solve complex problems and surprise the world with the real power of micro. From our invention of the Micro-Molder 30 years ago to our latest breakthrough technology for micromoulding, Accumold is on the path to satisfy our customer’s needs, even if that mean inventing something to make it work.

MPN: Over the 30 years, what sticks out as a major achievement for the business? AJ: As of this writing Accumold has over 270 employees. For a company to go from a rented garage and a handful of employees and make it through all of the obstacles small business face is quite the accomplishment. It speaks volumes about the need for the capabilities we have developed. We are blessed to have great leadership that continues to drive us forward. We like to think we are the largest in micro and we’d like to stay that way.

MPN: How has the market changed across that time and also over the last five years or so? AJ: If you think back to 1985 as the company was forming, what were modern microelectronics? Motorola had released its grey ‘brick’ cell phone. It was big, took two hands to use and only made phone calls. Today we have more computing power in our pockets than a dozen PCs of the mid-80’s. The acceleration of microelectronics has skyrocketed from that point forward and has really never slowed. More recently that momentum has shifted in a couple of ways. One, microelectronics has not only helped make things smaller but it has also help make things bigger. Think of TVs. Remember how big a 29” television used to be? Look at what’s available now! Micro technology has enabled devices to grow in ways only imagined in the cinema. One of the other major trends is where micro has gone outside consumer goods and in to markets like medical. Never before have we seen as much innovation in life sciences. Micromoulding has played a major role in helping advance new medical innovations. Just about every aspect from surgeries to personal care devices have generated a demand for smaller, lighter, cheaper, less-invasive, etc.

MPN: How has the company adapted to these changes? AJ: In some ways adapting and innovation are two sides of the same coin. I’m not sure we’d recognise the slow shift over the years because we’ve always aimed to meet our customers

where they are. Everyday a customer is looking to push the limits with micro-moulding and Accumold has been there every step of the way. Being able to solve that next problem is what has kept us relevant all these years.

MPN: What have been the most exciting developments in the injection moulding sector over the last five years? AJ: Some of the more recent developments in micro-moulding include what I call converging technologies. Process like, 3D-MID, micro-structure enhancement, or new material developments have all opened up new possibilities with micro plastics. For example, Laser Direct Structuring (LDS), or often called 3D-MID, is a process for selectively plating plastic for electronic devices. This technology has been around for quite a while but is gaining in interest especially when combined with micro-moulding. The ability to design micro parts without metal overmouldings, and with geometries once not achievable by standard manufacturing processes is allowing new innovations where it once thought not possible.

MPN: What specific injection moulding expertise does Accumold have that sets it apart? AJ: Accumold specialises in micro-moulding. There is no textbook definition but we describe it as: plastic parts micro in size, micro in features, or micro in tolerances. In many cases it’s all three. For example it’s common for us to make a part that is only 800 µm at its largest feature. Or have a requirement with just a few microns on geometric tolerances. These requirements are what set true micro-moulding apart from general moulding. Not every moulding supplier is equipped for moulding of this nature. What really sets Accumold apart is the 30 years of experience moulding these kinds of part. Today there are many different moulding presses on the market for one to buy. What they don’t come with is 30 years of experiences on how to build tools and processes for micro parts. It’s not just large tooling made smaller. Anyone who has attempted true micromoulding will tell you it’s a different world.

MPN: Looking ahead, where does the business see the injection moulding market in the next ten years? And where will Accumold be? AJ: We know our customers want three things: Capability, Scalability and Sustainability. We know we need to innovate to help our customers push the limits of their own technology. We know that our customers need us to be able to supply parts from prototype to millions a month. We know that customers want assurance they can have a supply partner that is here for the long haul. The supply chain partnership has become one of the most valuable components for today’s manufacturers. Accumold will break ground this spring on our third addition as one more step in meeting our customer’s requirements. This new facility will not only give us more manufacturing space but more room for innovation, the life blood of Accumold. As we like to say, “Bring us your ideal design and together we can surprise the world with the real power of micro.”

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Small wonder: Aaron Johnson, sees Accumold as one of the largest companies in micro ‘and we’d like to stay that way’

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SHAPING UP T

he UK’s medical devices market is one of the largest in the world, valued some 6.8bn ($10.2bn) and predicted to rise annually by around 6.8%. The Damian Hennessey, opportunity for the sector’s Proto Labs, looks manufacturers to increase at injecting change their sales and share of the into medical device world’s growing market is an attractive proposition design with liquid and one that is reliant on silicone rubber their ability to compete on the global stage – taking new and innovative products to market quickly and cost effectively. Having spent many years working with manufacturers in this very sector and being told that they have problems in sourcing ALL of the components they need in a timely fashion, I understand the risk and challenges that they are facing. Recent developments in the field of rapid injection moulding materials and techniques – particularly with Liquid Silicone Rubber (LSR) – are addressing many of the issues surrounding the heavy burden of testing and regulatory approvals. During the development phase, the component parts for many different design iterations need to manufactured and tested and this has been, up until now, a very time consuming and costly process. Whilst production volumes were often too small to cost-effectively produce using traditional materials and techniques, the developments in rapid prototyping and on-demand manufacturing services are enabling quick reaction to meet the manufacturers’ evolving needs throughout the product development cycle.

Benefits of using liquid silicone rubber When selecting materials for components in medical applications, properties such as sterility, flexibility, chemical resistance and coping with extreme operating temperatures and

pressures are all important factors – of course balanced with the need to provide patient comfort. Liquid silicone rubber (LSR) is one of the few materials able to meet such exacting requirements. A flexible thermosetting plastic, LSR is available in a range of durometers and compositions, allowing the material’s properties to be matched to almost any application. Unlike other materials it remains solid across a wide temperature range, including extreme heat or cold. This characteristic alone makes it ideal for many medical applications as it can be safely sterilised with heat or radiation. Additionally, LSR is inert and won’t react with most chemical agents; thus, it can be used to safely deliver a variety of substances. Due to its properties, including UV stability, crack and scratch resistance, LSR is being seen as the best material for the development of moulded components for:

• Reusable applications where heat is used for sterilisation (e.g. caps, valves, plungers and cables) • Seals, both between device components and that of devices and patients • Device hand grips, where durability and flexibility are critical • Replacing glass in many scenarios with transparent optical LSR

On-demand and low-volume production

The challenge for LSR prototyping is that viable stand-in materials do not exist. Hard plastics can’t duplicate most of LSR’s properties and even the most flexible thermoplastic materials can’t match LSR’s flow characteristics in a mould. Additionally, the very characteristics that makes LSR compatible for most applications makes it virtually impossible to form using short-run prototyping processes. LSR is too soft to machine and, being a thermoset, unable to be layered, leaving injection moulding as the only viable way to produce testable prototypes. This method delivers repeatable, reliable and consistent results throughout the manufacturing process. With injection moulding, parts made from plastic, metal and liquid silicone rubber (LSR) can be produced as early as possible — a crucial advantage during the regulatory approval processes. Medical device manufacturers can also quickly produce low-volume parts, with rapid injection moulding taking from a single day for simple items, up to around 15 days for more complex components. In addition, engineering-grade plastic and metal parts in quantities ranging from one to 200 can be machined in one to three days. The capability to produce low-volume products means device manufacturers can offer more customised medical products, test different iterations of a design and run through approvals much faster and more efficiently.

To meet strict industry regulations, manufacturers of medical products are often faced with several rounds of prototyping and testing throughout the development process. For some products and parts, early-phase testing can utilise stand-in materials, e.g. materials that perform similarly to the end-product materials, but are often cheaper or can be manufactured more quickly.

How LSR injection moulding stacks up

Flexible friend: A flexible thermosetting plastic, LSR is available in a range of durometers and compositions, allowing the material’s properties to be matched to almost any application

The key to success for medical device manufacturers is to source the materials that will be used in the final product as early as possible during the testing phase, then selecting a prototyping supplier that can quickly produce lowvolume manufactured parts that will see products brought to market swiftly – enabling UK manufacturers to complete on the world stage.

The faster a medical device manufacturer can get prototypes into an engineer’s hands, the faster the device can get to market and enable the manufacturer to strongly compete. I am often told by our customers that LSR is surprisingly cost effective, particularly when developing complex geometry parts and being able to cost the components quickly via an online quote system helps them to obtain comparative costs and better understand what works best for their specific project.

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Material world

or all manufacturers of plastic parts for medical applications, there is one problem that is a constant issue when using injection moulding technologies – that is material degradation.

Enric Sirera, Ultrasion, discusses injection moulding with no material degradation

All traditional injection moulding processes use the standard screw, barrel and heater band configuration, with material being melted well in advance of injection into the mould. It is this residence time that is inherent in all standard injection moulding technologies that leads to material degradation.

Ultrasion, headquartered in Barcelona, Spain, is now an established alternative injection moulding technology that is being used worldwide and which was created specifically to address the issue of material degradation. It does this by eliminating the reliance on screws, barrels, and heater bands and instead doses only the amount of material necessary per shot direct to the mould, where it is melted at the gate through the use of an ultrasonic horn is injected immediately into the mould. The basics of the ultrasonic moulding process is shown in figure 1. Using a dosage system that delivers the correct quantity of standard pellets for every shot, the production cycle begins with the mould already closed and dosed with raw material at room temperature. The material is then contacted by an ultrasonic horn or ‘sonotrode’ which is lowered, and as well as melting the material forces the polymer to flow into the mould cavities. The sonotrode then returns to its original position, and the cycle begins again. The ultrasound moulding technology is extremely precise, uses no heaters, and as already stated the process means that there is no material residence time, and no material degradation. In addition, as the energy needed in the process is only at the point when the ultrasonic horn contacts the raw material to induce melt, it uses upwards of 90% less energy than a traditional micro injection technology. Material wastage, a problem in all sizes of injection moulding machines, is a massive issue in precision and micro moulding applications, where in some instances upwards of 99% of material processed will be scrapped. Where this material is expensive as is the case of some critical medical mouldings, this becomes an even bigger problem. In the Ultrasion process, only the material required is dosed, and so runner and sprue wastage is all but eliminated.

The nature of the ultrasonic moulding process is such that material melt characteristics are very different from those produced in injection moulding machines. The application of high intensity mechanical vibration that transmits energy directly into the polymer molecular structure results in an extremely fast and efficient melting process ‘inside out’ rather than ‘outside in’ which is how melting occurs in injection moulding via the electric heater bands. In addition, the new sprue concept in the Ultrasion technology means that it behaves as an energy director, orientating the waves in the flow direction meaning that molten material and waves travel together towards the mould cavities, which induces extremely low viscosity (almost as low as water) in the melted plastic. The lower viscosity characteristics of polymers when melted via ultrasonics also means that the technology uses significantly reduced moulding pressures, typically not exceeding 350 bar as opposed to the more typical 2500 bar used in traditional micro injection moulding machines. This opens up an array of over moulding and insert moulding applications previously impossible, and also means that the technology can mould over intricate core pins or difficult core pin configurations which would either be destroyed or deflected using traditional moulding pressures. The technology has been designed for ease of use, and requires no more than a short orientation and training session as the machine is installed. There are a few simple adaptations necessary to the tooling for the Sonorus 1G, which are covered in the installation training and in specification documents that the company issues to all customers.

“

In the Ultrasion

There are no materials that cannot be process, only the processed using the ultrasonic moulding material required technology, with successful moulding dosed projects using everything from standard polypropylene to high density polyethylenes. The Sonorus 1G machine — which has been designed specifically for precision and micro applications — can accommodate shot weights from 0.05 g to 2.0 g.

In all materials, the reduced viscosity allows for the attainment of especially long parts or parts with extremely thin walls. The machine can easily mould 15 mm long parts with wall thicknesses of 0.075 mm, and achievable tolerances are in the region of 0.01 mm.

Sound process: Ultrasion’s ultrasound moulding technology uses no heaters and the process produces no material degradation

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7515 Distrupol Medical Plastic News - Q1 2015.indd 1

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Made in the UK

Seventies’ child: Paul Edwards, Pentagon Plastics. The company has been working in the medical moulding sector since the 1970s

INJECTION MOULDING

Fitting the mould T

he early years of the business saw Pentagon take over the moulding for a medical company based in Ireland where it supplied face masks, catheter tips, tiemann tips and bespoke respiratory Pentagon Plastics products. These products were moulded in various grades of PVC and K’Resin Styrenehas extensive Butadiene-Copolymers (SBC).

medical moulding experience, having provided a number of medical products to the market since the 1970s

Now the main focus of the company’s medical moulding sees them supply to a range of customers in the stoma care sector. Having assisted the development it continues to supply volume production of urostomy, colostomy, ileostomy and wound care products which includes full coupling and drainable systems. These products have provided the team with a depth of knowledge in moulding ethylene-vinylacetate (EVA), polyethylenes, acetals and thermoplastic elastomers (TPE). As a technical moulder of customers bespoke products Pentagon has also manufactured cases and covers for medical devices which are often moulded in ABS or polycarbonate and sometimes even a blend of both. Pentagon Plastics is involved at the early concept stage to assist in the development of a medical product. By working with its customer’s designer it can help ensure that a product or concept is compatible with the moulding process and can be manufactured to meet costing guidelines. This can be done easily with face-to-face meetings as well as transferring data electronically. Pentagon is able to support customers by drawing on its experience and knowledge of the medical industry, assisting them from concept, through all stages of tooling and the supply of final production. It will continue to assist customers after the development process and for the life of a component in production. The company describes its offering to the medical and technical moulding sector as unique as it provides a bespoke range of development tooling. The manufactured

Insert Systems fit within the company’s universal range of bolsters to assist the development stage of a product and keep initial tooling costs to a minimum. The Modular Inserts have some restrictions such as limited temperature control and restricted ability to produce undercuts, but offer the benefit of producing your finished component or part of a product to check key features such as fine detail areas. This tooling solution can also be utilised for early low volume production before investing in the full production tooling to meet higher volume demand. Full development mould tooling solutions can be manufactured in Pentagon’s on-site toolroom to further enhance the service. Some of the advantages of a full mould tool are that they provide dedicated temperature control, the option of full side action movement and enhanced gating (feed point) options. This will often mean that multi-cavity tools are constructed to secure an improved component price or meet heightened product demand. The material selection process is a vital step in any product development and drawing on the company’s years of experience within the medical moulding sector, Pentagon Plastics says it is well equipped to assist in this area, working closely with a network of approved suppliers who offer technical advice to assist the selection of thermoplastic material. Having moulded the majority of medical grade thermoplastics its setters are able to optimise the production process with great skill. To further enhance the product development stages the company operates a 3D printer and can provide SLA, SLS, and vacuum casting prototyping solutions as a managed service. While the product ranges supplied by Pentagon don’t require cleanroom moulding the company does provide strict clean working practices on all of the production that passes through its mould shop. This together with its experience of manufacturing and servicing medical mould tooling means it can offer a full service to those requiring non-cleanroom medical moulding.

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MATERIAL GAINS

nyone administering medication or fluids via medical device tubing can explain the challenges and risks associated with connectors. The variety of drug delivery systems, medical devices Eastman looks at and accessories using similarly designed connectors can cause confusion, leading enhancing patient to device misconnections and sometimes safety with design fatal mistakes. More specifically, the universal tapered design for small-bore connectors has contributed to cases in which fluids were provided to the patient intravenously when they were intended for enteral administration. These kinds of life-threatening errors can be prevented. That’s the goal of the International Organization for Standardization (ISO), which introduces new design standards for specific clinical applications, making them safer. The applications covered by the new standard, ISO 80369, include enteral feeding, neuraxial applications, respiratory and driving gases, limb cuff, inflation applications, intravascular and hypodermic applications, and connectors for urinary collection lines. The latest standard for enteral applications, ISO 80369-3, will help prevent misconnections between enteral connectors and connectors for other medical applications by standardizing their design for specific devices.

Addressing the need for consistency To reduce medical tubing misconnections, an international group of clinicians, manufacturers and regulators, along with ISO and the Association for the Advancement of Medical Instrumentation (AAMI), developed the ISO 80369 standards. These new standards require a complete design change. Enteral devices are the first of all the clinical applications to undergo this change with ISO 80369-3. The Global Enteral Device Supplier Association (GEDSA) launched the Stay Connected communications platform to support the transition and help to introduce

new connectors with supporting organizations and partner associations. An original equipment manufacturer (OEM), A Hopf is an associate member of GEDSA and will be supporting its members with enteral connectors that are consistent in design according to the new requirements. “Back in 2012, leading enteral companies worked together to introduce systems with safety connectors, but they lacked a consistent design,” said Michael Hopf, sales manager, A Hopf. “Now, industry partners are working together on ISO 80369-3 with the goal of worldwide consistency in the design of enteral connectors, helping to eliminate any confusion about different safety connectors and ultimately improving patient safety.”

Material selection To proactively address customer needs regarding performance and potential regulatory changes, the injection moulder and mould maker selected Eastman Tritan copolyester as a raw material suitable for a newly designed small-bore connector. “While working on the new design of a standard connector, we also had to consider the material that would be used in its development,” said Hopf. “At A Hopf, we saw Eastman Tritan copolyester as the future raw material for medicaldevice connectors such as stopcocks and y-connectors because it’s a BPA-free, new-generation copolyester that provides toughness, chemical resistance and stability post-sterilisation.” As part of the new standard, materials used to mould the connectors must be rigid to ensure it’s as difficult as possible for unrelated delivery systems to be connected. Eastman Tritan copolyester provides the stiffness required along with maintaining clarity and colour after sterilization, helping boost patient and health care provider confidence. Clarity has always been important for fluid administration because of the easy confirmation of flow. Colour may become more important in the future in which colour could be used to further indicate the type of connector and device. In addition, devices made with Tritan retain clarity and functional integrity following ethylene oxide and gamma Colour may sterilisation.

“

become more important in the future

“The significance of this initiative is reinforced by the number of industry leaders joining forces to proactively improve enteral connectors,” said Cedric Perben, application development, EMEA, Eastman Chemical Advanced Materials. “Eastman has a material in Tritan copolyester that can further help the initiative and improve patient safety.”

Improving patient safety A Hopf currently is providing the newly designed enteral connectors. The injection moulder and mould maker continues to monitor regulatory changes and proactively address any additional design requirements. Future proof: While working on the new design of a standard connector, A Hopf saw Eastman Tritan copolyester as the future raw material for medical-device connectors WWW.MEDICALPLASTICSNEWS.COM

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On the surfaceâ&#x20AC;Ś E

ngineering polymers, such as PEEK, POM, polyamides and PTFE have witnessed a remarkable growth in their use in recent years in medical product manufacturing, such as Henniker offers catheters, microcatheters, nasogastric feeding tubes and expertise on plasma endotracheal tubes to name surface treatment for but a few. They are typically PAD printing chosen for unique properties which include resistance to chemicals, high strength to weight ratio and of course relatively low cost. However, there are fundamental differences between polymers and other engineering materials which create unique technical challenges in a production environment. One important property is the characteristic low surface energy of polymers (see Table 1) and the resulting intrinsically poor adhesion characteristics. This is an important obstacle in achieving reliable glue joints and also PAD printing steps, where various types of markings must be permanent. Various methods of improving adhesion are available but often donâ&#x20AC;&#x2122;t lend themselves to production settings and frequently involve the use of harsh and environmentally unfriendly chemicals to physically attack and etch the surface of the material. Plasma surface modification offers a reliable and environmentally friendly alternative surface preparation for most engineering polymers. Plasmas can be a vacuum types (batch) or atmospheric types (in-line) and contain reactive gas species which, by careful choice of gas type and process parameters, can be used to increase the surface energy of a wide range of engineering polymers, and in doing so significantly improve wetting characteristics and therefore adhesion characteristics.

Table 1: Typical surface energies of different materials

SURFACE ENERGY (MN/M) Polytetrafluoroethylene (PTFE)

18.5

PEEK

30-40

Silicone

Poly(vinylidene fluoride)

Polyethylene (PE)

Polypropylene (PP)

Polystyrene

Poly(vinyl chloride) (PVC)

Nylon-66

Aluminum

~500

Glass

~1000

Stick with it: Batch and in-line plasma treatments can improve adhesion to polymers used in medical devices

Pic 1: Untreated PTFE surface

Pic 2: Plasma treated PTFE surface

In-line atmospheric plasma surface treatment has been successfully demonstrated to increase the surface energy of PEEK from 35mN/m to >72mN/m, ensuring permanent PAD print adhesion. The treatment is active on PEEK for several weeks and so parts can be stored until needed. For PTFE catheters, air is ineffective due to the strength of the C-F bond. Batch processes are preferred which allow different plasma gases to be used and which are more effective in fluorine extraction from the surface. This process also increases the effective surface area which in turn improves ink adhesion as shown in the SEM images below for untreated and plasma-treated PTFE. The surface energy of PTFE is raised from 18mN/m to >72mN/m in this case also.

Conclusions Both batch and in-line plasma treatments offer a reliable and repeatable surface preparation method for improving adhesion to a wide range of engineering polymers used in medical device manufacture. Applications include gluing and PAD printing of catheter tubes for example.

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ANTIMICROBIALS

Dead cert Iker Principe, Cikautxo Medical outlines the company’s latest R&D developments in leaching / non-leaching antimicrobial solutions for its vascular access catheter portfolio

t is well known that endovascular catheters are exposed to a risk factor of biofilm growth along its surface and, in those cases, infections may sometimes occur causing to patients an extra damage and to hospitals an extra cost. For this reason, in the US market, approximately two third parts of the catheters purchased have some antimicrobial and/or anti-thrombogenic performance. Unfortunately Europe has not the same legislation but some European hospitals have made their balance and started to increase the percentage of catheters purchased with those performances. How does the anti-microbial technology work? There are two main methods to kill bacteria: method one or ‘leaching’, involves adding a substance to the catheter that is released inside the vascular system attacking the bacteria growing colony being created on its biofilm surface. There are in the market catheters with different substances to be leached, the best known are silver ions, antibiotics and even chlorhexidine. Heparin is also used as anti-thrombotic agent. The main constraint of this first method is that the principle used is based on a release of a substance into the vascular system of the patient with secondary effects that might counterbalance its antimicrobial or its antithrombotic benefit. For this reason the R&D developments are focused to release the minimum quantity of substance capable of keeping the effect during the target period. A second method has also been developed: the ‘non leaching method’. In those catheters, the surface is treated with a non-leaching substance that kills the bacteria when it approaches and with no contact. This method does not release any substance along the vascular system of the patient and no secondary effect occurs.

What anti-microbial technologies are offering the manufacturers? Some European Contract manufacturers are offering nonleaching catheters to European branded manufacturers. This is the case with Cikautxo Medical. Our customers, the big catheter branded manufacturers, select different technologies in order to differentiate themselves in the market: some of them give priority to the time-to-market aspect and choose a simple silver ion technology that we manufacture embedded into the catheter tube and accept this ‘leaching’ option that releases a small (always under the regulatory limits) silver quantity into the vascular system. Some other customers prefer a longer term anti-microbial / anti-thrombogenic solutions based on chlorhexidine and accept the potential downsides of this second ‘leaching’ method (perhaps a remote allergic anaphylactic risk). Although we also have a solution based on a cocktail of antibiotics, today we are focusing our efforts in new generation technologies, especially in our latest development, a ‘non leaching’ natural polymer anti-microbial coating and its anti-thrombogenic version based on heparin. How does this last generation of anti-microbial technology work? The natural polymer acting as a ‘selective non-contact bacteria killer’ is linked into the catheter surface after a special surface activation treatment is done to the catheter. Once the complete process is finished, we cure the catheters to eliminate any possible volatile agent. The bacteria attack is made by a technology called ‘positive charge’ which is an ionization killing activity that emits no leaching substance into the vascular system. In addition, combining this natural polymer with heparin obtains an excellent last generation catheter that has both anti-microbial and antithrombogenic activity.

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www.cimedtech.com

LEFT | Attack attack: Cikautxo uses a bacteria attack which is an ionization killing activity that emits no leaching substance into the vascular system

BELOW | Double whammy: There are two main methods to kill bacteria â&#x20AC;&#x201C; â&#x20AC;&#x2DC;leachingâ&#x20AC;&#x2122; or â&#x20AC;&#x2DC;nonâ&#x20AC;&#x201C;leachingâ&#x20AC;&#x2122;

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ANTIMICROBIALS

IT’S A BUG THING . . .

here has been growing development and use of antimicrobial plastics in response to public, private and institutional demands for plastic products and product components that inhibit microbial Plastics Color Corp growth. While medical research continues to outlines the growing target constantly-evolving microbes including so-called ‘super bugs,’ advances in resinrole that antimicrobial compatible antimicrobial additives technology plastics play in the have drawn the plastics industry into the healthcare industry antimicrobial battle on several fronts. Plastics products with enduring antimicrobial properties include medical devices and equipment, food preparation surfaces, household appliances, auto interiors, computers, and other personal and recreation devices and equipment. The global market for biocide additives is expected to grow at a CAGR of 4.4%, from $275 million in 2010 to $390 million in 2018, according to Global Markets for Plastics Additives, a report by Wellesley, Mass-based BCC Research. Stronger growth is expected in the Asia-Pacific region (5.1%) than in the North America and European segments (3.7% each).

Bioadditives address consumer concerns The use of antimicrobial additives in plastics isn’t new. Biocides have traditionally been added to industrial, commercial and consumer plastics as a passive means for protecting products from degradation by microorganisms. These additives have proven particularly useful for products such as plastic pipe and conduit and outdoor furniture – items which are exposed to the damp conditions that encourage microbial growth. Biocide additives are certainly experiencing a period of growth. Asia-Pacific is poised for strong growth in healthcare antimicrobial plastics with a forecast CAGR of 16% through 2017, according to Healthcare Antimicrobial Plastics – A Global Strategic Business Report from Global Industry Analysts (GIA). “With development of more porous, washable, and efficient plastics, the application of antimicrobial plastics in healthcare is expanding into medical implants and other biomedical devices. The need to prevent hospital-associated infections (HAIs) and related complications is a major impetus for the development of novel biocides, antimicrobial polymer technologies, and innovative applications deploying these solutions,” according to the report. Among the most common biocide additives are silver nanoparticles, OBPA, OIT, and DCOIT. Depending on the composition, many of these biocides can be compounded as stand-alone additives or as part of a masterbatch. While Oxybisphenox Arsine (OBPA) dominates global biocide production, “concerns about the long-term environmental damage and human toxicity are leading to a shift in preference for more eco-friendly, natural, and safe antimicrobials such 42

Clean sweep: Plastics Color offers a new antimicrobial formulation – MicroBlok Z – which contains zinc compounds instead of the silver ions in the original MicroBlok

as inorganic silver-based biocides,” according to the GIA report. An expert in antimicrobials compounds, Plastics Color Corp, manufactures colour concentrates, compounds, customfunctional masterbatches and other polymer technologies. The company offers its MicroBlok antimicrobial formulations for polymers, engineered to impede the growth of a wide spectrum of microorganisms on various plastic surfaces. The MicroBlok line is targeted at the medical device, medical packaging, appliance, and other consumer markets where cleanliness is crucial to consumers. MicroBlok inhibits the growth of bacteria which may cause stains, odours, and product deterioration and helps keep products cleaner and fresher longer. MicroBlok has undergone rigorous laboratory testing under ISO 22196:2011. The ISO test measures the growth of bacteria within a 24-hour period on the tested plastic substrates. The antimicrobial is appropriate for use in virtually any manufacturing process and in a variety of resins including TPU, PE, PP, PC, and ABS. It can be custom-formulated for any special manufacturing process. MicroBlok employs silver ion-based antimicrobials engineered into the product and dispersed throughout the polymer matrix. These ions create a large ‘internal’ specific surface which creates an extremely high-efficiency antimicrobial action. Plastics Color also offers a new antimicrobial formulation – MicroBlok Z – which contains zinc compounds instead of the silver ions in the original MicroBlok. Zinc’s antimicrobial effect is derived from its ability to disrupt membrane transport by blocking the proton pump that energizes the transport mechanism. This creates an extremely high efficiency antimicrobial action. The zinc compounds within MicroBlok Z are not depleted during the inhibition process, thus the antimicrobial effect of MicroBlok Z is not diminished over time. MicroBlok Z is custom-blended to user specifications in a variety of resins including TPU, PP, and PE. MicroBlok Z is appropriate for virtually any moulding or extrusion application where temperatures do not exceed 240˚C (464˚F) and can be custom-formulated for any special manufacturing process. MicroBlok Z antimicrobial is engineered into resins during the compounding process, eliminating the need for secondary manufacturing steps. Antimicrobial plastics formulated with antimicrobials help suppress the growth of odour and staincausing microorganisms on the treated plastic, but they are not intended to be a substitute for good hygiene or to prevent food-borne or infectious illnesses.

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MATERIALS

Material Assets T

hree key trends driving innovation in the medical device industry today are prevention of infection, demand for single-use devices, and the shift toward home healthcare. Material suppliers are adapting to support these market needs, developing Ben Porter, Trinseo, chemically resistant plastics which are explains how the robust to sterilisation and aesthetically company is meeting pleasing. The latter trend is driven by medical requirements demand for home healthcare devices, for which OEMs require non-industrial, with its resins aesthetically-appealing equipment. This demands materials that meet functional, aesthetic, performance and haptic requirements. Therefore, Trinseo’s TS&D team is showing its capabilities in meeting medical requirements with the Magnum ABS resins, demonstrating the potential benefits for customers involved in home healthcare. These resins were designed for automotive applications, suiting both extrusion and injection moulding and meeting stringent material specifications. However, several Trinseo tests show that Magnum suits a range of medical applications such as housings for inhalers (asthma sprays), injection devices (diabetes), hand-held monitoring and other home healthcare devices. Therefore, Trinseo obtained biocompatibility on Magnum 8391 MED, making it Trinseo’s offering for injection moulded applications in the home health device market. Trinseo’s Magnum ABS resins use continuous mass polymerisation technology. This article discusses the main benefits of mass polymerisation over emulsion process technology here, followed by an overview of multiple performance tests, and findings that validate suitability for a healthcare environment.

In an emulsion process the reaction of monomers occurs in water through a batch process. This requires high levels of emulsifiers (surfactants) to maintain a suspension of the polymer. The latex is then coagulated, producing an ABS concentrate. Coagulation requires salts or acid to separate the polymer from the water. This concentrate is compounded with SAN to make an ABS resin for injection moulding. This method results in impurities including surfactant and coagulant residuals. The compounding step adds thermal history to the resin and the final product is more yellow.

Putting Magnum 8391 MED to the test Trinseo conducted tests to identify the market fit of Magnum 8391 MED for medical applications, specifically: Base colour comparison, adding colour masterbatches; thermal stability / moulding performance at different conditions; UV stability in indoor exposure and residual volatiles levels. Magnum 8391 MED was compared with established, betterknown, emulsion ABS resins. TEST ONE: BASE COLOUR COMPARISON With emulsion ABS the end product has a yellower colour due to higher polymer processing aid loading. ABS produced in a continuous process yields a resin with a highly consistent, white base colour. For aesthetic reasons, mass ABS is preferred because its whiter base colour is easier to self-colour, especially for light colours used in medical applications. It appears ‘cleaner’ and more visually appealing. Figure 2: Natural resins manufactured through eABS versus mABS

With mass ABS different ingredients are added throughout a continuous process. Mass polymerisation cascades a series of reactors resulting in several chemical processes, specifically tuned for optimal rubber grafting and particle sizing. The process begins with a solution of uncrosslinked rubber dissolved in a mixture of monomers and solvent(s). At the end, the residual monomer and solvent is removed, leaving highly pure ABS.

Figure 1: Emulsion vs. Mass ABS Production Process

Tests also measured colour differences based on the CIE LAB colour system which measures colour along three axes. Figure 3: The CieLAB colour system

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MATERIALS

Here, colour data points are subdivided into three colour axes L, a and b, resulting in the final E value.

dE = da 2 + db 2 + dL2 Colour comparisons were made based on three optical scenarios to capture different visible perceptions: Daylight; evening light with a higher yellow and red light fraction and artificial light representing a shopping environment. Since Magnum 8391 MED offers a whiter colour than emulsion ABS, a colour masterbatch was added: a pure TiO2-based colour masterbatch with approximately 50% pigment loading, as the predominant colour in medical is white. Figure 4 shows a first comparison divided into L, a and b values for a ‘medium-coloured’ ABS with 3% of masterbatch loading. Both grades show sufficient colour saturation which explains little difference on L values. The a values (“red/green”) are very close, too. The main difference is visible on b values, determining the yellow to blue differences. The emulsion ABS has a higher b value, relating to a more yellow color. This value has the most impact on the resulting ΔE value. Figure 4: Competitive resin performance versus Magnum 8391 MED (with 3% white Masterbatch)

Figure 6: Thermal stability of MAGNUM ABS resins versus competitive resins in Daylight (D65), Evening light (A10) and Artificial light (F11)

TEST THREE: UV STABILITY As most hospital or home healthcare devices are designed for indoor use behind windows, a UV stability study was done. QUV-A represents a typical indoor exposure and was selected for this purpose: MAGNUM 8391 MED and incumbent emulsion ABS resins were exposed in the UV-2000 tester according to the following ASTM G154 conditions: U.V.-A 340 nm lamps; eight hrs UV at 60 C black panel temperature; four hours condensation at 50 C black panel temperature; E = 0.77W/m As mass and emulsion ABS offer different starting points regarding colour (yellowing level), the 3% white masterbatch (approx. 50% TiO2 pigment loading) was selected for UV investigations to put both materials at a comparable colour level. Colour measurements were taken after 24, 48, 72 and 100 hour exposures. Due to less impurity in the final product, Magnum 8391 MED remains more colour stable over time.

This observation is enforced when looking at a fairly ‘overloaded’ emulsion ABS with a 3% Magnum 8391 MED loading. Still, a higher Δb remains for the Emulsion ABS. So even with more than double the colour pigments loaded, this emulsion ABS can’t deliver the same white colour as Magnum 8391 MED, underlining the potential cost savings due to less use of colour masterbatches for white colours.

Figure 7: Results for QUV-A (with 3% Masterbatch 744)

QUV-‐A 15

Figure 5: Competitive resin with 6.25% MB 744 versus 8391 Magnum MED

∆E

compe**ve resin (Emulsion ABS + 3% MB 744 (white) Magnum 8391 + 3% MB 744 (white)

5 0

50 $me [hours]

TEST TWO: THERMAL STABILITY Trinseo also measured differences in discoloration at molding temperatures of 220 C versus 300 C for both ABS types. The results show an average discoloration ΔE of 0.98 for MAGNUM ABS whereas the discoloration of emulsion ABS was around 1.25. This test shows that MAGNUM offers improved thermal stability. This translates to a more robust and stable converting process with a wide processing window. Emulsion ABS showed a higher discoloration of over 25%.

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100

MATERIALS

Vola&le sec&on, determined by GC and HPLC 1.6

Figure 8: Percent Volatiles of emulsion versus mass ABS

1.4 1.2 1 vola&les [%] 0.8 0.6 0.4 0.2 0

compe&&ve resin

Magnum 8391 MED

Figure 9: Lot-tolot Consistency of ABS Resins versus Competitive Resins

TEST FOUR: VOLATILES Many healthcare device providers want to minimise the migrating volatiles in materials for their devices. Regarding thermoplastics, the fraction of residual monomers, di- and trimeres are potentially relevant, as they are fairly volatile. To determine the level of volatiles, a gas chromatography (GC) and high performance liquid chromatography (HPLC) are used. The cleaner manufacturing process helps Magnum 8391 MED to have a smaller volatile profile than competitive emulsion ABS.

Conclusion Trinseo tests show clear advantages of using Magnum Mass ABS technology in the medical industry. A more compact product regarding volatiles, along with its purer base colour make Magnum 8391 MED suitable for medical device manufacturers. Magnum produced in a continuous mass ABS process results in a resin with a highly consistent, white base colour, making it suitable for easy and consistent self-colouring.

Self-colouring can be cost competitive and offers other benefits to OEMs and molders, letting a manufacturer buy a polymer resin and add colour masterbatch at the injection molding machine stage, instead of buying different compounded grades, which is costly. Trinseo can also offer pre-coloured options.. The superior natural base colour of Magnum resins is very attractive. Studies show high potential cost savings of around 50% for light colours due to less colour masterbatch usage. Compared with emulsion, Magnum‘s beneficial UV stability means parts last longer, taking longer to discolour. The high purity and low residual volatiles offer benefits for medical applications. In summary, Magnum ABS resin offers a more stable and robust solution for converters and is a good market fit for medical applications, affording technical and economic benefits.

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MATERIALS

Boning up T

he introduction of PEEK-OPTIMA HA Enhanced, says Invibio Biomaterial Solutions, signals the next step in the development of high-performance materials for interbody fusion devices. The properties that have made According to Invibio, PEEK-OPTIMA Natural one of PEEK-OPTIMA HA the leading interbody fusion over the last 15 Enhanced could become biomaterials years – a modulus similar the leading material for to cortical bone, imaging interbody fusion devices compatibility, biocompatibility after demonstrating and processing adaptability are maintained with PEEKenhanced bone ongrowth –OPTIMA HA Enhanced, which and providing a more incorporates hydroxyapatite favourable environment for (HA), the main inorganic fusion to take place in pre- constituent of bone. The benefit, however, is that clinical studies key PEEK-OPTIMA HA Enhanced demonstrates enhanced bone apposition, within four weeks, compared with PEEKOPTIMA Natural in a pre-clinical in vivo study. [1] Over the years, the osteoconductive properties of HA and its ability to promote bidirectional bone healing have been demonstrated experimentally, as well as in clinical studies.

[2-5]

Now, results from a study carried out at the Surgical & Orthopaedic Research Laboratories (SORL) at the University of New South Wales (UNSW), under the direction of Professor Bill Walsh, indicate that PEEK-OPTIMA HA Enhanced may provide advantages in mechanical performance, new bone formation and quality of new bone bridging compared with the current market leader, PEEKOPTIMA Natural, as well as with allograft bone. In the SORL study, 25 fully mature female sheep were randomly assigned to three test groups to undergo cervical fusion at two non-adjacent spinal levels: PEEK-OPTIMA HA Enhanced v. Allograft, PEEK-OPTIMA Natural v. Allograft, or PEEK-OPTIMA HA Enhanced v. PEEK-OPTIMA Natural. The outcome measures, including micro computed tomography (micro CT) and histological assessment were evaluated at 6, 12, and 26 weeks following surgery.

Results The biocompatibility of PEEK-OPTIMA HA Enhanced was supported, and all of the implant materials were well tolerated in the study. Both PEEKOPTIMA Natural and PEEK-OPTIMA HA Enhanced devices remained structurally intact throughout the implantation periods. In contrast, there was significant resorption of the allograft implants, and fracture of the devices was evident as early as the six+week time point. In total 6/13 (46%) allograft implants fractured during the implantation period. Allograft devices showed a high degree of new bone formation and incorporation into the surrounding bone. This was countered however, by the high degree of resorption and mechanical instability, leading to fracture. Micro CT did demonstrate that new bone formation was greater with the PEEK-OPTIMA HA Enhanced devices compared with PEEK-OPTIMA Natural at six weeks (Figure 1). The quality of new bone bridging between the vertebral bodies and contributing towards fusion also appeared to be superior in the PEEK-OPTIMA HA Enhanced group compared with PEEK-OPTIMA Natural, at both the six and 12 week time points (Figure 2). Upon histological examination, the local bone inside the PEEK-OPTIMA HA Enhanced devices appeared to be more robust at six and 12 weeks compared to the local bone inside the PEEK-OPTIMA Natural devices at the same time points. These differences were less evident at 26 weeks, but remained suggestive of a superior result for graft in the PEEK-OPTIMA HA Enhanced devices compared to PEEK-OPTIMA Natural (Figure 4).

Figure 1: Micro CT analysis of new bone formation in the fusion as well as the device surface.

Figure 2: Micro CT analysis of the quality of new bone formation bridging in the fusion, as well as the device surfaces.

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Finally, from the micro CT analysis, there was a trend towards greater direct bone contact with the PEEK-OPTIMA HA Enhanced devices compared with PEEKOPTIMA Natural, and this was more evident at the early time points (Figure 3).

Figure 4: Histological comparison between allograft, PEEKOPTIMA Natural and PEEK-OPTIMA HA Enhanced demonstrates the status of the graft material inside the devices over time.

The SORL/UNSW pre-clinical study supports the notion that PEEK-OPTIMA HA Enhanced provides a more favourable environment than PEEK-OPTIMA Natural or allograft bone in a cervical fusion setting, incorporating an osteoconductive surface throughout the device for: • Superior mechanical performance: PEEK-OPTIMA HA Enhanced devices outperformed allograft, with fracture of allograft devices in 6/13 (46%) instances. • Superior new bone formation: PEEK-OPTIMA HA Enhanced resulted in greater new bone formation at 6 weeks compared with PEEK-OPTIMA Natural. • Superior quality of new bone bridging: PEEK-OPTIMA HA Enhanced resulted in a higher quality of new bone bridging at 6 and 12 weeks, compared with PEEKOPTIMA Natural. The introduction of PEEK-OPTIMA HA Enhanced polymer to the market offers a unique combination for improving bone apposition and provides surgeons and implant manufactures with a new, more advanced standard in interbody fusion. In recent months, regulatory clearances for PEEK-OPTIMA HA Enhanced devices have been granted via the FDA’s 510(k) route in the US, and by CE mark in the EEA. More are expected in the near future.

Figure 3: Micro CT analysis of direct bone-implant contact.

References 1. Study evaluated the bone on-growth of PEEK-OPTIMA and PEEKOPTIMA HA Enhanced in a bone defect model in sheep. Data on file at Invibio. This has not been correlated with human clinical experience. 2. Coathup, M.J. et al. A comparison of bone remodelling around hydroxyapatite-coated, porous-coated and grit-blasted hip replacements retrieved at post-mortem. J Bone Joint Surg-Br, 2001. 83: 118-23. 3. Aebli, N., et al. In vivo comparison of osseointegration of vacuum plasma sprayed titanium-and hydroxyapatite-coated implants. J Biomed Mater Res Part A, 2003. 66: 356-63. 4. Moroni, A., et al. Histomorphometry of hydroxyapatite coated and uncoated porous titanium bone implants. Biomaterials, 1994. 15: 926-30. 5. S balle K. Hydroxyapatite ceramic coating for bone implant fixation. Mechanical and histological studies in dogs. Acta Orthop Scand Suppl, 1993. 255:1-58

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BEADY

Slick WORK

eye

Keeping an eye on the next big thing can be hard. Each issue of MPN selects a company, service or technology that it thinks is the one to watch . . .

Who are you and what do you do?

My name is Dave Smith and I am CEO and co-founder of LiquiGlide. I co-invented LiquiGlide’s technology with Professor Kripa Varanasi while pursuing a PhD at MIT. We co-founded LiquiGlide together in 2012. I now lead the company to pursue commercial opportunities for our patented technology for creating slippery liquid-impregnated surfaces.

LiquiGlide is a technology platform that allows us to create permanently wet, slippery surfaces. Our Dave Smith, CEO and coatings combine a textured solid co-founder, LiquiGlide, with a liquid to outlines the company’s create a liquidlatest technology that can i m p r e g n a t e d The create a permanently wet, s u r f a c e . solid layer is like slippery surface, which has a microscopic a significant potential for sponge, and the the medical sector liquid is held in place within the solid texture by capillary forces. The result is a permanently wet slippery surface that is only a few microns thick. Each LiquiGlide coating is customized to meet the specific needs of the application, and the ingredients for each coating are chosen from hundreds of different materials.

We recently announced an exclusive licensing agreement with Elmer’s Products. We are also speaking with companies in the medical, industrial and oil & gas industries, exploring strategic partnerships in those fields.

Describe your latest innovation?

Because LiquiGlide is a technology platform and not just a single substance, it can be customized for many applications. Anywhere there is a viscous liquid that could more easily slide across a surface, our technology can help. We look at each application and its unique challenges. Because our platform is so flexible and we can create customized solutions to address new challenges that our clients present to us, our innovation comes from addressing these challenges. For the medical industry, we are exploring how LiquiGlide’s technology can help clog prevention in tubes and stents, implanted joint lubrication and medicine administration efficiency.

What does it mean for the medical sector?

The medical area has a host of applications where coatings are used, yet what they are using now is insufficient. With blood and other bodily fluids, there is always

What projects have you been focused on recently?

We’re predominantly working with consumer packaged goods companies, as that is where we received the most initial interest. Beyond consumer packaged goods, we think there are unlimited potential applications – from agrochemical to medical to oil and gas. We feel a real sense of urgency to bringing our coatings into the various industries where they can make a difference. For the medical industry, for example, our coatings can literally save lives. Everyone in the company really believes in our mission.

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the chance of coagulation. With LiquiGlide, coagulated fluid can still slip through tubes instead of creating a block. Another good example is the catheter used for brain haemorrhage. Right now they drill a small hole in the brain, put a thin tube into the hemorrhage and try to drain it out. But very frequently, that tube gets clogged and they have to flush it or replace it. Every time they go in and out of the brain, there is a lot of risk, and it makes the process longer. Using LiquiGlide-coated tubes, they would never need to remove or flush the drainage tube. One tube—one use from start to finish. It makes it a faster, safer process.

Plans for the future?

To date, we have had over 6,000 inquiries about our technology, and we currently have more than 30 paying clients who we are working with to develop custom coatings. For the medical area, we are looking a strategic partner to work together to improve equipment, create efficiencies and save lives.

Smooth operator: Dave Smith, CEO and co-founder of LiquiGlide – a technology with a host of medical applications

ADVERTORIAL

Nolato Medical offers tight tolerances with high process capability.

Nolato Medical’s catheter balloons are known for their extremely high quality Nolato Medical is a world leading supplier of high quality latex catheter balloons. The balloons are used worldwide by major medical device manufacturers. Sales have grown strongly in recent years because of Nolato Medical’s high level of service and outstanding quality. The balloons are known for their superior material properties in purity, symmetry and resilience. These properties are crucial for several catheter applications such as Embolectomy, bipolar pacing, stone extraction and thermodilution. Applications where the balloon is often the most critical component. “A validated process and an excellent raw material compound are keys to manufacture catheter balloons efficiently with high quality,” explains Kristian Sandberg, product manager at Nolato Medical.

New product development projects During recent years, Nolato has been part of several successful NPD projects. “We can offer a dedicated and experienced project team assisting in balloon design. Additionally, we have very short lead times for balloon samples,” Kristian Sandberg adds.

Outsourcing of in-house manufacturing Through efficient outsourcing programs, some customers have completely shut down in-house balloon manufacturing and outsourced the operations to Nolato Medical. Outsourcing to Nolato ensures improved quality at a lower overall cost. “One of our customers, a major US based medical device company, lowered their market complaint rate by 40 percent using Nolato Medical’s latex catheter balloons,” says Kristian Sandberg as an example of a successful program. “An improved balloon quality opens up possibilities for increased sales for your balloon devices,” he ends.

Nolato Medical is a long-term, global partner within the development and production of polymer products for market-leading medical technology and pharmaceuticals customers. Fifty years of experience in advanced medical technology operations has given us a firm foundation of cutting-edge expertise and quality awareness, which feature strongly in everything we do today. For more information about catheter balloons, please contact Kristian Sandberg, product manager at Nolato Medical. Phone +46768 880061 or e-mail kristian.sandberg@nolato.com.

www.nolato.com/medical Visit us in our stand at Medtec Europe

100%

ONLY MEDICAL. ONLY PHARMACEUTICAL. ONLY HEALTHCARE

Ci Medical Technologies devotes 100% of its expertise as the multifaceted manufacturer of injection-molded components for the medical device industry. Since 1971, we’ve been the single-source for design, manufacturing, assembly, packaging, and logistics worldwide. From concept to market, it’s this total commitment that makes us Ci Medical. Learn more at cimedtech.com

Formerly

Corporate Headquarters Latrobe Manufacturing Facility 149 Devereux Drive Latrobe, PA 15650 USA P: 724-537-9600 F: 724-537-2477

New Name. Same Commitment to Innovation.

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