MPN EU Issue 27 by MPN Magazine

MEDICAL PLASTICS news

MODERN WAY

Adhesives Extrusion Polyolefins

THIS IS THE MODERN WAY - making a success of emerging markets ISSUE 26

Sept-Oct 2015

WWW.MEDICALPLASTICSNEWS.COM

www.netstal.com

Outstanding quality High returns Are you looking for an injection molding system for certified production to the highest of standards? Do you need to supply your customers with superior quality health-care products? Then Netstal injection molding systems are a must have! Our team is made up of experts specialized exclusively in the manufacture of medical components. This guarantees maximum output at a consistently high level of quality. Fakuma, hall A7, booth 7303/7304

Engineering Excellence

CONTENTS Sept-Oct 2015, Issue 26

Regulars

Features

5 Comment Blurred lines . . . Lu Rahman looks at what we view as a medical device

23 World of difference Owen Mumford and IDC talk emerging markets

7 News analysis Life science market trends 8 Digital spy 11 News profile Lux Research looks at the 3D printing market 17 Speech therapy With a Q&A from Pentagon Plastics

29 Freeze frame The use of polymers in regenerative medicine 30 Performance art Injection moulding expertise from Netstal 33 Material gains Borealis discusses polyolefins

34 Dublin up Medtech in Ireland 37 Stick with it Lu Rahman looks at whatâ&#x20AC;&#x2122;s happening in the adhesives sector 40 Smart thinking Nordson EDI talks extrusion 43 Part of the process Focus on Fakuma

46 Beady eye Episurf talks to MPN

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Brilliant performance | ENGEL medical

ENGEL medical Fully-electric machines impress with great performance. The ENGEL e-motion medical series combines best-of-class performance with maximum cleanliness. Optimised for clean room applications, the machine has an encapsulated barrel to minimize particle and heat load, along with encapsulated injection unit drives and an oil return unit on the toggle lever as standard features. The ENGEL e-motion medical is available as a continuous series with up to 500 tonnes clamping force.

Clean and precise. With ENGEL medical. Because it is about life.

more than a machine Visit ENGEL at Fakuma 2015 13 â&#x20AC;&#x201C; 17 October | Hall A5 | Stand 5204

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be the first.

MPN

All Medical, All Plastics

CREDITS

EDITOR’S

group editor | lu rahman

comment

deputy group editor | dave gray editorial assistant | emily hughes advertising | mandy o’brien art | sam hamlyn

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© 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)

BLURRED LINES

e used to have a clear cut concept of what constituted a medical device. However, with the increased use of technology via smart devices for example, the idea of what is and isn’t a medical device is becoming less straightforward. The use of smart watches, chips and apps have burgeoned in use and where we once we thought of a medical device as something found on a hospital ward, their shape and form have shifted to become increasingly complex pieces of technology. The rise in illnesses such as diabetes has fuelled the change in device design. New ways of treatment and drug formulations mean that more patients are able to manage their own treatment at home out of a hospital setting - so new devices have had to accommodate medical advances. Devices are becoming smaller and are often not able to even be seen, offering a new wave of product design. Implants containing microchips are on the rise. Whether we’re talking cochlear implants, pacemakers or contraception that releases drugs via a wireless signal, the market for implantable devices is strong. So if we are happy to implant a chip under our skin and call it a device, are we happy to think of our smart phone in the same way? Recently Blackberry was reported to be producing a bacteria-free device for use in hospitals showing this is a potential key market for mobile manufacturers. In a recent article for MPN, Neil Oliver, Accutronics commented: “Doctors, emergency services and patients have benefitted and countless lives have been saved or improved, but a recent consumer trend, has raised concerns. Our pocket pal, the mobile phone, has experienced even faster product development lifecycles, with

new iterations available every six to ten months. “This increased dependency on our smartphones has resulted in a wave of portable medical devices which can connect directly to the phone, with an app relaying an on the spot diagnosis. Heart rate and blood pressure monitors are already extensively used in tandem with mobiles and tablets. More complex devices for patients with chronic diseases, such as glucose meters for diabetics, pulse oximetry and kidney infection machines, as well as ultrasound wands and smart fitness monitors are all flooding the market.” In an article in The Wall Street Journal, Eric Topol also highlights the way smartphones have changed everything from shopping to entertainment and now medicine. He writes: “Medicine is next. With innovative digital technologies, cloud computing and machine learning, the medicalised smartphone is going to upend every aspect of health care. And the end result will be that you, the patient, are about to take centre stage for the first time. “With the smartphone revolution, an increasingly powerful new set of tools—from attachments that can diagnose an ear infection or track heart rhythms to an app that can monitor mental health—can reduce our use of doctors, cut costs, speed up the pace of care and give more power to patients.” It will be interesting to see how this new wave of medical devices affects future manufacture of products. Whether we’re talking materials, coatings or the microchip technology, device design is demanding a rethink to meet the needs of a changing healthcare sector.

WWW.MEDICALPLASTICSNEWS.COM

“

Where we once we thought of a medical device as something found on a hospital ward, their shape and form have shifted.

NEWS ANALYSIS

Life science trends –

WHAT WE CAN EXPECT

Increasing demand -

Alternative forms of financing -

Demand for new drugs and medical devices continues to increase, with estimated pharma sales reaching US$1.23 trillion in 2014. Factors, ranging from ageing and increasing populations and huge unmet clinical needs, remain the drivers.

Innovative forms of financing continue to develop. For example, royalty financing enables investors to receive a percentage of a company’s revenues up to an agreed multiple of their investment. Investors benefit by being able to earn a return immediately rather than having to wait for a traditional exit (such as an acquisition or IPO).

James Baillieu, senior associate at global legal practice Norton Rose Fulbright LLP, lists the trends and developments we can expect to see in the life science sector in the coming years

Investment activity is up Given the huge demand and the recovering economy, investment activity across the sector has ramped up. In the UK alone, venture capital funding in 2014 was US$713 million, up over 41% from 2013. Likewise, IPOs raised over £400 million in 2014, including Circassia Pharmaceuticals and Horizon Discovery Group, among others.

Personalised medicines In recent years, there has been a growing amount of research into so-called personalised medicines which target specific therapeutic areas or are genetically compatible with a patient. For example, Northwest Biotherapeutics is developing a range of personalised cancer vaccines for some of the most aggressive forms of cancer. Personalised medicines will become more commonplace in the years ahead.

M&A activity is up -

Digital health -

Pharmaceutical companies completed or announced a record of over US$500 billion of mergers and acquisitions globally in 2014. Deal activity is driven by the need for companies to replenish their drug pipelines (following patent expirations), dispose of unwanted assets, increase scale and expand into emerging markets. Earn-outs which link additional payments to the satisfaction of agreed regulatory and/or commercial milestones - remain popular, helping to bridge the valuation gap between buyers and sellers.

Over the coming years, there will be a significant increase in digital technology. Examples include wearable sensors that monitor patient non-compliance and provide realtime data on patient health, ingestible ‘smart’ pills with microchips and novel drug delivery systems. For example, a ‘smart’ pill for schizophrenia made by Proteus Digital Health has recently had its application accepted by the US Food and Drug Administration. The pill contains a sensor which detects when the pill has reached the stomach before communicating with a wearable patch placed on the patient’s skin. This patch then onward transmits the information to a mobile device. It remains to be seen whether this ‘smart’ pill will be approved but many similar products are in development.

IPOs return to London In the past, UK-based pharma companies often elected to list on NASDAQ in the US, where the pool of investors and analysts are greater than in the UK. While some companies continue to ‘go west’ - such as GW Pharmaceuticals and Adaptimmune- a US listing is no longer considered essential. In addition to those companies that have listed in London (see above), some US companies, like Verseon Corporation, have reversed the trend and listed in London. European companies, like Faron Pharmaceuticals and Unibio, are also exploring London listings.

New entrants The rise of technological innovation has drawn companies traditionally associated with technology and the internet into the sector. For example, the likes of Google Life Sciences, Samsung Biologics and LG Life Sciences now operate in the sector and in some cases collaborate with traditional players. For example, in 2014 Novartis and Google announced a partnership to develop smart contact lenses that track glucose levels in the tears of diabetics and send the data wirelessly to a mobile device. Tests in humans are due to commence in 2016.

1) World industry outlook: Healthcare and pharmaceuticals, The Economist Intelligence Unit, May 2014. 2) US regulators accept ‘chip in a pill’ application. The Financial Times, 10 September 2015

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DIGITAL

spy APPY TALKING

SIMON FOWLER, FROM SOFTWARE EXPERT, ADVANCED EXCHEQUER REVEALS HIS TOP APPS FOR BUSINESS PROFESSIONALS TO IMPROVE EFFICIENCY 1Password The app creates unique passwords and stores them all in one place. By entering a ‘master’ password, users can quickly access all passwords to ensure they never forget log-in again. All data stored within 1Password is protected using secure technology. Doodle The online scheduler coordinates meeting availability for multiple attendees. The organiser can use Doodle to send a poll with a suggested meeting date and time to a group of recipients who can quickly confirm whether they are free, eliminating back-and-forth emails and telephone calls. Evernote Users can make and share notes, take pictures and capture any data which they can access at any time. From storing receipts to capturing presentation slides and web-based articles, Evernote backs up files between a smartphone, computer or tablet. Any.Do This task planner streamlines organisation and management of ‘to do lists’ and synchronises them across multiple devices. Any.Do’s auto-suggest feature and voice recognition technology enables users to share tasks with their contacts to increase project collaboration. Docs to Go By providing the ability to edit and create Microsoft Office files and view PDF documents on Android smartphones and tablets, Docs to Go helps busy professionals work from anywhere. Dropbox The cloud-based solution securely stores documents, photos and videos which can be distributed from multiple devices. Users can create shared folders to work on projects where files can be uploaded and synchronised with ease. Dropbox can also send large files without using email attachments, reducing the strain on IT infrastructures. TurboScan Smartphones are transformed into multipage scanners for documents, receipts, notes and other text using TurboScan. Documents are stored as multipage PDF or JPEG files, eliminating manual processes such as submitting expense claims. The app can also send files to a predefined email address or upload them to online storage sites like Evernote. 8

MEDICAL MATERIALS UPDATE

Wearable infusion device market BENEFITS FROM UNMET DRUG DELIVERY NEED

ew device class addresses the void between injectors and traditional infusion according to Greystone Research Associates The increasing number of drugs that must be infused has led to the development of a new class of drug delivery devices – devices that can deliver therapeutic drugs in volumes up to 10 mL and higher to ambulatory patients. These wearable subcutaneous infusion systems are targeting the growing need for administering biologicals – a segment that includes monoclonal antibodies, immune modulators and blood factors – that are indicated for chronic conditions. These devices distinguish themselves from syringes and injectors by delivering drug volumes in excess of 1-2 mL for durations that are measured in minutes rather than seconds. The demographics of patient populations and the current trend in therapeutic drug development are converging to create an increasingly steep demand curve for infusion. About 20% of drugs in the pharmaceutical development pipeline are monoclonal antibodies.

As currently formulated, these therapeutic biologicals require dosage volumes well in excess of the upper range for traditional subcutaneous delivery, and are currently delivered via infusion. By providing a delivery option that avoids the cost impact and logistical burden of patient travel to infusion sites, wearable infusion systems are seen as patient-friendly and fiscally responsible. Several products in this device class have already reached the market and recent agreements between device suppliers and pharma companies are serving to validate the market need that wearable infusion systems address. Wearable infusion systems are expected to achieve and sustain double digit unit growth through the end of the decade.

DIGITAL SPY

HOLD TIGHT

itralit UV 4050 LV is a new low-viscosity and transparent adhesive for plastic, glass and metal bonding from Techsil. It has been designed to be easily integrated in automated production lines. It is hoped the product will be big in the medical devices sector and is currently being tested according to USP Class VI and DIN ISO 109934/-5 standards for use in medical applications. The adhesive has been developed by German adhesive manufacturers Panacol. It has low viscosity,

WWW.MEDICALPLASTICSNEWS.COM

making it the perfect choice for tight bond gaps. Techsil says it provides excellent adhesion to most plastics as well as metals. If at least one assembly material is transparent, Vitralit UV 4050 LV should cure quickly to produce a strong and reliable bond. The ability to cure with visible light (>400nm) permits the bonding of UV blocked materials like polycarbonate. It cures in seconds with UV-A and visible light. Both gas discharge lamps and LEDs are suitable to use for curing. High intensity gallium doped gas discharge lamps produce excellent curing results, says Techsil.

DIGITAL SPY

talking

POINT

MAIN STORY

Proto Labs

launched additive manufacturing service

roto Labs has expanded its production facility in Telford, with the addition of an additive manufacturing service for custom prototyping. Together with its CNC machining and injection moulding services, Proto Labs can now help designers and engineers take a product from the initial stages of prototyping through to low-volume production.

beat this

Proto Labs’ additive manufacturing service can produce parts in sizes up to 736mm by 635mm by 533mm, using a selection of thermoplastic-like materials that mimic ABS and polypropylene.. Lee Ball, Proto Labs’ operations director, said: “We are excited to be able to offer this new additive manufacturing service to our customers in Europe.

Fast worker: According to Lee Ball, additive manufacturing will allow companies to accelerate product development

“When compared with the commonly available fused deposition modelling (FDM) processes that are popular with hobbyists, stereolithography (SL) offers a vastly improved level of resolution, accuracy and surface finish. SL can build parts with a layer thickness of 25 microns (0.0250mm) compared with the typical, entry-level FDM layer thickness of around 127 microns (0.127mm).

“Fast-moving businesses demand expertise, scalability and a quick turnaround of products to stay ahead of the competition. Professional additive manufacturing will allow companies to accelerate product development and turn ideas into real products in a matter of days.”

TWITTER WATCH @designcouncil Championing great design We liked… We’ve teamed up with @MedCityHQ & @ AXAPPPhealth to launch #MedTechSouthEast. Find out how you could change #medtech @MDTinnovation Medtronic’s innovation project We liked… Stem cell technology could lead to ailing heart mending itself #medtech @HealthierIT Online content for digital health We liked… Wearables: The Promise And Peril For Medtech Companies… @enmedical A dynamic innovation portal for medical device design We liked… Going from napkin sketch to #medtech sold via @amazon

INNOVATION

www.transmedics.com

Have a heart

ransMedic’s Organ Care System (OCS) ‘heart in a box’ system device is the first medical device capable of maintaining donor organs in an optimal state outside of the human body for longer than six hours. The device can keep a heart alive from the moment it is removed from a donor’s body until it is placed into the recipient’s body. It minimises cold ischemia injury by filling the heart with warm oxygenated blood, optimises the condition of the organ by replenishing oxygen, nutrients and hormones that would otherwise become depleted while providing monitoring and assessment of the organ until transplant. WWW.MEDICALPLASTICSNEWS.COM

Device company adds digital dimension to stethoscope Eko Devices is running a pilot with Stanford Hospital, where all residents will be using the Eko Core device as a training tool. The company has also released the device to be purchased by the public. What does it do? Eko Core allows doctor to see heartbeats in wave form on a mobile device as well as hear the sound at an amplified level. Both the visible and audible data can be recorded and shared between physicians and hospitals. This can take a lot of the guesswork out of detecting murmurs, valve problems, and blockages in the arteries. Why what was behind its development? A member of Eko Devices was diagnosed with a heart murmur as a child. This experience was behind the decision to develop a tool that would increase the diagnostic accuracy of clinicians and support them in differentiating between innocent and pathologic heart murmurs at the point of care in order to avoid unnecessary referrals, anxiety, and expensive screenings. Though stethoscopes are used by over 20 million clinicians around the world as the first line of detection and diagnosis of heart murmurs and abnormal heart sounds, the 200-year-old analogue tool underutilises even the most basic digital technology. The Eko Core was developed to address a specific clinical need for a wireless, digital, and smartphone-connected stethoscope that would simplify cardiac and pulmonary monitoring for clinicians around the world. What do we need to know about the company? Eko Devices says it is aiming develop a healthcare experience that is actionable, mobile and delightful for future clinicians and consumers. The company is building a modern medical toolkit of smart devices that will allow the US healthcare system to transition from a service-based ‘sickcare’ model to one that incentivises quality outcomes and preventative care. 9

NEWS PROFILE

Medical 3D printing – WHERE ARE WE?

he biggest leap for medical 3D printing still lies ahead. Starting to address the eternal dream of engineering replacement organs, so that a patient who needs a transplant doesn’t have to search for a donor, has led bioprinting developers, such as Milos Todorovic, Organovo and Emulate, to focus on organ-onLux Research a-chip devices useful for biopharmaceutical look at where we development and diagnostic applications. are with medical Following in their footsteps, companies like EnvisionTEC and Syseng use their multiapplications of 3D modal systems that integrate multiple print printing and says heads to switch between printing living cells, that while mankind biomaterials, and thermoplastics during the awaits replacement same process to produce multimaterial end products, such as cellular networks on top organs, nuts and bolts of a biocompatible scaffold. The next step dominate the market for development in this space will primarily focus on creating organ tissues with specific sub-organ features like a kidney’s nephrons and creating supporting structures such as vasculature. While some of the 3D printing systems are already capable of printing cells, proteins, DNA, and drugs, there are significant barriers to mainstream adoption in these segments of healthcare, and it will be at least another decade before we see any meaningful clinical applications of 3D printing in organ transplantation. In the meantime, more immediate medical markets will focus on implants, prosthetics, and orthopaedics, with knee and hip replacements presenting a very compelling business opportunity given the combined size of these markets is close to $15 billion. In the day and age of personalised everything, a key driver for medical 3D printing has become customisation. Medical professionals find significant value in customising the design of medical devices to fit each patient’s unique anatomical and physiological needs. Dentistry professionals were among the first to adopt 3D printing technologies, with dentists, oral surgeons, and orthodontists now commonly producing crowns, bridges, stone models, and orthodontic appliances using in-office 3D printing equipment. Companies like Sonova led adoption of the technology in the auditory space, by 3D printing custom fitted hearing aids to ensure proper device positioning in the ear and, therefore, optimal hearing improvement for patients. In just a few short years the market grew to the point where the majority of the hearing aid manufacturers now offer devices that are personalised to the shape of the customer’s ear. Prosthetic applications for 3D printing have utilised the same customisation impetus that drove interest in the dental and auditory markets. Lower leg prostheses have become a popular early application thanks to the relatively simple design and large market for such devices – driven, in part, by the increasing veteran amputee population. Variations on these devices range from 3-spark’s lower leg prostheses with integrated, 3D printed strain sensors to Standard Cyborg’s waterproof products meant for use while swimming and bathing. More recently, 3D printed hand prosthetics have become a major medical application of interest, thanks in large part to the efforts of consortiums like e-NABLE and the Open Hand Project focused on low-cost prosthetics for less developed regions.

clearance in the space, but spinal implants have garnered significant interest in the past year, highlighted by FDA 510(k) clearances for Joimax and Oxford Performance Materials (OPM). Titanium implants like Joimax’s EndoLIF spinal fusion implant have dominated the implant space thanks to the material’s relative strength and biocompatibility, but OPM’s PEKK-based spinal implant represents the first 3D printed polymer-based load bearing implant. Further development and commercialisation of lower cost polymer-based devices will prove to be a major driver for adoption of 3D printed devices given healthcare providers and payers’ increased focus on lowering healthcare costs. In closing, as witnessed by the sheer breadth of medical applications of 3D printing, the future for this rapidly growing industry looks bright. However, major obstacles still loom large, the biggest ones related to regulations, performance, and the limited selection of (biocompatible) printable materials. With the visions of custom-fitted medical devices printed at home and new hearts beating in the chests of heart attack survivors, it is important to understand that years of additional research and development are needed to reach commercial maturity for these more demanding applications. While mankind awaits the unlimited supply of replacement organs, the industry will look for mechanical nuts and bolts – from dental and cochlear implants to joint replacements and surgical tools – to fuel the growth in the next five to ten years.

Future proof: According to Milos Todorovic, Lux Research, as witnessed by the breadth of medical applications of 3D printing, the future for this growing industry looks bright

Orthopaedic implant applications have also benefited from patient-specific customisation. Knee and hip joint implants were among the first to receive regulatory WWW.MEDICALPLASTICSNEWS.COM

We have big news. And itâ&#x20AC;&#x2122;s tiny.

Proto Labs introduces additive manufacturing to its suite of services

NOW AVAILABLE:

Xtreme White 200

in sizes up to 736 x 635 x 533mm

Our advanced 3D printing technology is capable of incredible new levels where the layers are as thin as 50 microns. With this tiny level of detail, you can be confident when creating intricate designs, from small parts with complex geometries to large parts with precise patterns. And youâ&#x20AC;&#x2122;ll have your product fast, because we build with rapid stereolithography (SL) to produce a range of plastics for prototypes and low-volume production runs in as little as one day.

Get a fast interactive quote at protolabs.co.uk or call +44 (0) 1952 683047 for more information.

ADDITIVE MANUFACTURING CNC MACHINING INJECTION MOULDING

NEWS ANALYSIS

GREAT DANE

ituated on the outskirts of ‘wonderful, wonderful Copenhagen’ in a small town called Vaerloese, the Gerresheimer facility stands at 12,000m2, having been built back in 1964, before the company was known as a specialist supplier to the Medical packaging medical sector. Back then the group had group Gerresheimer operations in many different packaging has sites all around the markets.

world, but from one facility in Denmark, the group produces vast quantities of innovative packaging solutions for some of the biggest names in pharma. Dave Gray takes a look through the doors at Gerresheimer

Last year the Danish arm of Gerresheimer celebrated its 50th anniversary. Originally called Dudek Plast, it was founded in 1964 by Peter Dudek, who is now 86. There are currently 100 employees at the two Danish production facilities in Vaerloese and Haarby.

ABOVE: From one facility in Denmark, the group produces vast quantities of innovative packaging solutions for some of the biggest names in the industry

Today though, the Vaerloese site is used for the manufacture of the group’s Duma and Dudek branded portfolios for pharmaceutical packaging.

Twist and shout Duma Twist-Off, was first launched way back in 1992 – notable for its cap design. Over the years the portfolio has seen many variations, and this year a new product was launched which re-thinks the concept altogether. Improvements include more uniform wall thickness, optimised closure design and compatibility with all other high quality Duma Twist-Off and Duma OneLiner closures. But most noticeable change is the new closure which is designed to be user-friendly for the elderly (it can be easily opened using the side of a coffee table or with a biro pen) and yet maintains child-resistance.

The DropAid design is simple but clever

LEFT: This year a new product was launched which re-thinks the Duma concept altogether

“We want to ensure that elderly citizens who aren’t as strong as they used to be can still open their tablet containers,” said Niels Düring, global executive vice president, plastic packaging. “But we also want to prevent curious children in the family from being able to swallow their grandparents‘ tablets.” Walking around the factory, it’s clear that Gerresheimer has a strong emphasis on design quality. But speaking with Niels Düring, it also becomes apparent that innovation still has a major role to play. He explains that dispensing is one key area where the group sees potential for development. In fact Düring revealed that the group has developed 12 new dispensing solutions. He added that 40% of all prescribed medicines do not achieve their full effect, either because they are taken at the wrong time, at the wrong dose, or not taken at all. The healthcare system is driving innovation here, as it becomes increasingly intolerant of the cost and waste of misused medicines.

Seeing eye to eye As an example, Düring demonstrated DropAid – a delivery solution for eye drops. The design is simple but clever. Not only does it make the dropper bottle easier to open, it also allows the user to position the bottle so that the eye drops end up in the eye rather than around the edges. Above it all though, quality is key for the group. “Quality is crucial in our business,” explained Our tour is concluded by Charlotte Borgensgaard, chairman of the group’s quality council. “Quality is crucial in our business. Quality is something that affects us all, because we all take medications at some time or other.” The company operates a global quality initiative which involves a close collaboration with all quality managers around the world.

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SPEECH THERAPY

VOCAL

exercise Who are you and what do you do?

Iâ&#x20AC;&#x2122;m Paul Edwards, managing director of Pentagon Plastics, a plastic injection moulding business based in Horsham West Sussex. We have enjoyed trading for over 43 years and our business continues to go from strength to strength. Our comprehensive range of injection moulding services include design assistance, development, toolmaking, injection moulding and post moulding operations.

How would you sum up your company?

We are experienced in technical moulding and processing high engineering grades of thermoplastics. Tailoring our services to the individual needs of the customer we are dedicated to delivering quality components in an efficient and timely manner. We are part of a small circle of businesses that run our own onsite toolroom facility in addition to the moulding services with the capacity to provide low cost tooling solutions right through to dedicated multi-cavity mould tools. We are able to produce volumes as low as 10 off up to the higher end of 100,000 off which means we can cater for a vast range of customer requirements.

Name a business achievement you are most proud of.

We are very proud of the transition that has occurred in the family business from first generation to second generation leadership. The infrastructure of the business has been reshaped during this period of transition and the profile of the business within the industry has grown.

WWW.MEDICALPLASTICSNEWS.COM

What excites you about this industry?

The last couple of years have seen companies sending products overseas for manufacture. Looking to claw back control and quality of their production parts, companies are turning back to UK manufacturers for both new projects and to re-shore existing projects from overseas. Far East manufacture will always have its place and can be of real benefit to those looking for cost effective high volume production however for technical products the UK is and has always been strong in its capabilities of both tooling and manufacture. It excites us greatly to see both the confidence and demand for UK manufacturing continue to rise. Seeing the skill set that looked to be diminishing come full circle with younger generations taking an interest in engineering careers brings new ideas in to our long standing and skilled industry.

Where do you predict industry growth will come from over the next 12 months?

As new medicine evolves and with continued research in to life threatening illness we are confident that a good portion of industry growth will come from the medical moulding sector. With people living longer there is more demand than ever in the medical industry to care for our ever increasing population and as medicines and medical technology continues to evolve we are sure that it will bring with it and increasing demand for injection moulding manufacture.

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

It would have been fantastic to have been involved in the design and development of the syringe - it would have been a springboard for many more systems within the industry.

SPEECH THERAPY

9 As soon as I get to the office I like to make sure I’m properly prepared for the day by identifying and prioritising tasks and then answering my emails.

Before I leave for the office I always try and review the day’s events and prep for tomorrow.

A discussion with our manufacturing partner. We then review plans and timelines for things like oral device funding opportunities and communications with our partner at University of Sheffield for surgical application of EIS.

THE CL D OC UN

I collate and update data from ZedSCan evaluation centres. This is our main product which is now being used in hospitals around the world. It helps speed up the detection of cervical cancer.

We carry out ongoing analysis of evaluation data and try to pick out any anomalies and then clarify with each centre. I do this with Chris Harris, product marketing manager and commercial director.

Twice a week we have a management meeting where we round up and update the Zilico team as well as chat about upcoming plans we have for the business.

DR PETER HIGHFIELD L DIR TECHNICA

ECTOR, ZIL

ICO

One o’ clock is lunch time. One thing we always try and make sure we do at Zilico, is have lunch together. It’s a great chance for everyone to catch up with one another.

Midday and it’s time for an all-important review of demand and production planning with Catherine Davidson, our product marketing manager.

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l director at eld is technica hfi ig H r te Pe r D n for its design mpany is know Zilico. The co medical re of real-time and manufactu dScan. This Ze hich includes w s ic st opy (EIS) no ag di nce spectrosc da pe im l ca tri uses elec detection. rvical cancer to improve ce

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Online quality assurance of medical tubes The X-RAY 6020 PRO from SIKORA is a sophisticated system for continuous process control and online quality supervision during the production of medical tubes. Your benefits: • First class product quality by an online measurement of wall thickness, inner and outer diameter, eccentricity and ovality of medical tubes like catheters, cannulas, oxygen or suction tubes • Increased productivity and cost saving • No start-up scrap • Process stability • Reliability with no need for calibration

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COVER STORY

THIS IS THE MODERN WAY A

n opportunity exists for any business with the ability and willingness to engage in commerce with emerging markets. However, potential hazards exist that can result in unforeseen, unfortunate consequences.

Bing Carbone, Modern Plastics, highlights the opportunities that exist by doing business in emerging markets

Virtually any company which has been involved in manufacturing or distribution in the past 10 years or so is aware that the term ‘local business’ is almost extinct or at least has morphed into something quite different – from what it was a short time ago.

You are no longer competing for business with the competitor down the street, but also across the globe. The reverse is also true; your potential customers are no longer restricted to the same area as your business; in fact you may have to dial an international code to call them. One of the more exciting, potentially financially rewarding aspects of the new economy is taking advantage of countries and regions globally that are on a comparatively rapid rise. Typically this growth is tethered to a significant event that moves the plates sufficiently to change the previous course the country was on. This might be a revolutionary change in the political climate or the discovery of resources previously unknown or under-developed or the development of relatively inexpensive but well trained labour pools – something that causes the buying population of that country to suddenly have more disposable income – and of course, innovation breakthroughs. Suddenly, previously potential customers that were not even on the radar screen become targets. However, all of this potential for new growth and expansion doesn’t come without risk. When a company decides to transact with a customer overseas, some risks are inherent in almost all cases. Language barriers can be challenging and certain legal contractual arrangements between countries adds complexity and costs in doing business. If your customer can’t or won’t pay for your products or services after they have been provided, litigation can be more costly and time-consuming than it would be for a domestic non-payment dispute.

For that reason, many companies have long held policies restricting trade with foreign customers to payment in advance. Some of these customers understand this and are more than willing to comply; with some others it isn’t always so simple.

Labour opportunities Some emerging markets such as China, Brazil and other countries in South America and Asia are emerging because many manufacturers from developed nations have chosen these locations because of the inexpensive labour pools. Some environmental regulatory issues are far more lax than they are in the parent country, providing economic opportunities. In situations like this, where an established, company expands overseas, opportunities exist for a vendor of that company to ease into emerging markets while mitigating the payment risks mentioned above. Some of my experiences expanding into emerging markets began this way and have been rewarding. Modern Plastics is celebrating 70 years in the plastics distribution business in 2015. We are a distributor of plastics stock shapes-sheet, rod, tube and film and custom plastics fabrication. One of the points of difference between ourselves and most of the more traditional distributors of plastics is that years ago, we saw the value in investing in advanced quality procedures and certifications. We are ISO certified 9001:2008 and ISO 13485:2003 (medical-device) certified. We have an on-staff quality control director, bar-coded inventories, full traceability and record retention that goes far beyond traditional distribution models.

Orthopaedics in focus One of our largest markets is medical devices – in fact, we have a medical plastics division dedicated to serving the needs of this industry. Orthopaedics play a large part. Traditionally, most of our customers in this segment were based in the US. Manufacturers of orthopaedic devices are typically large companies with sterling reputations and excellent credit ratings.

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COVER STORY

Several years ago more and more of these orthopaedic manufacturers started taking advantage of the the benefits discussed earlier regarding shifting some manufacturing to emerging markets, albeit slightly behind some other industries. Regulatory and other factors that exist with a medical device manufacture have made the decision more complex. As manufacturers did this, transferring key vendors in the supply chain for materials to local sources in these emerging countries was often not seen as advantageous; selection of vendors for these companies is arduous, and a high level of trust is built over the years that can’t be reproduced easily. These companies asked for and received our cooperation in supplying their offshore manufacturing plants with the same products we supply to them domestically.

In store: Cross-section of the medical plastics controlled storage facility

This provides an opportunity to get more involved in engaging with emerging markets while keeping risks to a minimum. Even though we were shipping goods to these locations, we were still in essence doing business ie – invoicing and processing purchase orders – with the parent Take a peek: Spinal cage made from Evonik domestic company. Vestakeep implantable PEEK

All of the laws and rules of engagement that existed previously were as intact as they were before. We had the opportunity to benefit from the expansion of commerce into emerging markets with little of the associated risks. Eventually, this association led to relationships with other businesses in those countries that were not owned or divisions of the larger ones that led to this engagement. At that time, decisions had to be made in terms of how we would proceed with these smaller companies, if at all. We proceeded with caution, but confidence. Several significant changes in the plastic market regarding new applications for existing polymers, such as implantable PEEK (Evonik Vestakeep) which we distribute, led to opportunities in places like South America. Talented, ambitious entrepreneurs have started new companies that have reached out to us as an established provider for these materials and requested direct engagement with us. Each opportunity is welcomed and investigated to determine the best path forward. While issues such as payment, transportation and laws regarding commerce should a dispute arise, at first may seem daunting, with proper due diligence these are manageable issues. Our company has benefited by our participation in these markets. We have been able to successfully leverage our relationships with the more established companies to form new ones with new companies.

emerging markets to look outside of their geographic footprint drives them to seek other options. If your company positions itself to be on their radar, your company can benefit.

Role of social media

Another way we have managed to be on the radar when opportunities arise is using web presence and social media. We have reevaluated what a website can and should be. We are integrating social media as a way of reaching out more than we have in the past and we are seeing the positive results. Often, these results are coming from emerging markets, where again, if not for social media, our existence would not be known by the potential client. As globalisation continues, more firms will be presented with the choice to engage with emerging markets. By the same token more ountries will become candidates for global trade, becoming new participants for the emerging market landscape. Firms that are:  Willing to engage in less traditional business climates  Actively on the lookout for opportunities with current customers who may be engaging in emerging markets  Marketing in places that expose them to global opportunities  Developing a web presence that can reinforce advertising and create new opportunities through social media will be able to capitalise on this trend. Those who do choose to engage should keep in mind these points to protect their investment:

In addition to business garnered from our traditional customers, our decision to advertise in publications with a global readership has provided exposure we would not ordinarily have had. We have been able to successfully take our company’s primary message of quality assurance and broadcast it to countries that are looking for just such sources.

What to be aware of:  Remember laws that may protect you domestically may not internationally.  Payment should be carefully negotiated – at times upfront payment should be considered.  Trust takes time to build. Understand this goes both ways – your customer needs to earn your trust as much as you need to earn theirs.  Due diligence is always appropriate as with any business transaction.

Many of these new relationships are with medical device start-up firms that know the materials they need, but are looking for the right sources to get them. They may not have the confidence they would like from their local sources who may not be aware of some of the newest materials available. If aware, they may not have access to them. The need for

A business must provide compelling reasons for customers to want to buy from them no matter where they are located in the world. In the end, business is still the same as it is in your own backyard. The same rules apply and that includes a good dose of business intelligence, skills and plain common sense.

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EMERGING MARKETS

World of difference

he market for innovative medical devices is growing at an exponential rate, opening new opportunities for life-changing products. The emerging pharmaceutical markets of Asia are expected, with a few exceptions, to grow this year and beyond, most providing attractive platforms for investments in the local industries, according to a series of analyses.

Owen Mumford’s Jarl Thailand looks to have one of the best Severn and Lewis Owens, outlooks due to its position as an entry discuss their experience point to the more remote countries of of investing in emerging Southeast Asia. (1) And, in Malaysia, the markets as a medical industry has high growth potential, both in the domestic and export markets, in view device manufacturer. of its present strength in the production of They look at working generic drugs. Over the last decade, the with new customers and Malaysian pharmaceuticals market grew partners, exceeding at between 8-10% annually. The market is based on a strong domestic generic sector expectations and and imports of branded and patented ultimately improving medicines. patients’ quality of life across the globe Malaysian opportunity Speaking more specifically, the Malaysian pharmaceutical industry has invested substantially to upgrade itself to meet the latest Good Manufacturing Practices (GMP) requirements, in accordance with the domestic as well as international Guidance.(2) Malaysia is a member of Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation

Scheme (PIC/S), which indicates that the local industry has established high pharmaceutical manufacturing standards, becoming a core region for many pharmaceutical companies.(2) Looking to provide additional resources to better serve its customers worldwide, Owen Mumford recently opened a new regional hub in Malaysia. Severn discusses the opportunities within the market further. “The Asia Pacific region is home to 61% of the world’s population 5, whilst in 2014, Asia Pacific countries accounted for less than 10% of Owen Mumford’s total turnover. As the region has seen economic growth, governments have increased their per capita investment in healthcare provision6, with APAC countries also reporting a high prevalence of diabetes Owen Mumford identified the need to make a difference within the region.7” “Continued success by the market development team in winning business with customers in Australia, the Philippines, Malaysia, Singapore and Thailand further highlighted the need for a local regional facility to act as a hub to increase our speed and flexibility when supporting potential and existing business within the region.” Severn continued, “Several locations in the region were considered before Malaysia was identified as the optimal location. Malaysia was selected as the preferred option due to its relatively stable political environment with a good economy and positive business friendly approach.” “A local company, Owen Mumford Sdn Bhd was set up in 2014, and in early 2015 a location was identified for our

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EMERGING MARKETS

regional hub in Nusajaya. The facility was completed at the end of May this year, and we are actively working to deliver the vision for Owen Mumford Malaysia: developing our presence in the region by growing our business out of this new regional hub.”

this market. This includes partnering with pharmaceutical companies and with the right national / regional distributors to reach the private hospital sector. It’s also important to identify retailers’ unmet needs and offer product and services according to current and future market needs.”

“Initially the Malaysia hub will bring in-house services currently outsourced in the region, allowing us to respond more quickly to customer demands, create bespoke product presentations for private label opportunities and shorten the response time for products to the existing customer base. The long-term vision is to use the Malaysia facility to complement the Owen Mumford global resource footprint and enhance our service levels worldwide.”

Looking to Mexico

Looking ahead Another market Owen Mumford has looked to expand into is Latin America. Latin America and Asia stand out as the principal growth regions, each having expanded an average of 14% per year between 2008 and 2012 and are expected to maintain an average pace of 12% per year through 2017. (3) More specifically, local producers of generic drugs are becoming the driving force of the pharmaceutical market, manufacturing branded products as well as private labels for pharmacy chains. A study conducted by Nadro, a Mexican medical wholesaler, indicates that pharmacy chains and supermarkets went from controlling 69% of Mexican pharmaceutical sales in 2007 to 88% in 2014, reducing the participation of independent owners. (4) With the appointment of a new country manager in Mexico, Owen Mumford is keen to build and develop a strategy within Latin America. Owens adds: “We have a well-defined strategy to focus on government tender business in order to be successful in

“Owen Mumford’s primary focus is the initial growth and establishment of the Mexican market, followed by a staged growth using the Mexico footprint as the gateway for the rest of the LatAm market. Mexico has a beneficial strategic geographical location, since it’s situated between the Atlantic and the Pacific Oceans. This forms a connection with the North and South of America, this making Trade agreements and common language (Spanish) enhances product transfer across country borders,” says Owens. “Mexico has an open trading relationship with the world and the most Free Trade arrangements, making doing business in and with Mexico highly beneficial. Mexico has economic growth and rising healthcare focus, as the burgeoning middle classes look for higher quality products and better services. As an employer, Mexico also has a hotbed of well-educated talent that is now on par with China in terms of capability, resourcefulness and value. “Owen Mumford has invested significant time and resources understanding the key issues and drivers for the Mexico and wider LatAm markets. Mexico’s future is bright and we want to do our part to make Mexico a vibrant, colourful and productive leader in LatAm.” Latin America is a strong bet for future growth. Brazil will continue to be the primary driver of healthcare expenditure in the region, accounting for 43% of the region’s pharmaceutical sales between 2013-2017, followed by Mexico as the region’s second largest market with 17% of the region’s sales. Brazil is expected to become the world’s fifth largest pharmaceutical market by 2016. Columbia and Peru also show promise, with strong growth prospects.(3) Severn adds: “We have a long history of innovation and our mission is to provide solutions that will exceed expectations, encourage compliance and improve quality of life. We export over 85% of our products and as such have many years’ experience in trading overseas. We are delivering against our strategy to grow our sales and presence in new market geographies whilst continuing to expand our market share in our established territories. With our investment in Mexico and Malaysia, this will further support future business generated from the Latin American and Asia Pacific regions. By entering new markets and introducing new products to our existing customers, I am confident our growing product portfolio and commitment to innovation will help us deliver on our long term growth plans.”

References: http://www.fiercepharma.com/story/emerging-asian-pharmamarkets-poised-show-solid-growth-2015-report/2015-01-28 http://www.matrade.gov.my/en/foriegn-buyers-section/69industry-write-up--products/520-pharmaceutical http://americasmi.com/en/expertise/articles-trends/page/latinamerica-pharmaceutical-sales-to-grow-12-per-year-through-2017 http://americasmi.com/en_US/expertise/articles-trends/page/latinamerican-pharmacies--right-for-the-picking http://www.unescap.org/stat/data/syb2011/I-People/Population. asp CIA Fact Book IDF Diabetes Atlas 2014

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Market FORCES 26

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EMERGING MARKETS Opportunity knocks: IDC believes there are huge opportunities for Western companies looking to develop medical products for China, India and other emerging markets

World vision: According to Dai Chinese medical companies want quality and innovation that competes with the best products globally

Knowledge share: YiFei Dai (Pictured left) and Stephen Knowles (Pictured right), IDC, discuss Western companies developing products for China and India

n the last five years there have been some changes within the emerging markets of China and India, with an attitude shift towards innovation and quality. And with the huge growth opportunities presented Industrial Design Consultancy – 10% a year in Chinese medical markets – can Western companies (IDC) advises about emerging really afford not to buy in?

markets. IDC China’s, YiFei Dai, shares her experience on the ground in China and Stephen Knowles, IDC in the UK, discusses Western companies developing products for China and India

Since IDC established a Chinese arm of its product design consultancy back in 2008, the company has seen an emerging market that is ready to embrace many Western medical de-sign principles. YiFei Dai explains, “China no longer wants a culture that just copies Western medical products with inferior quality. Leading Chinese medical companies understand this and they want both quality and innovation that competes with the best products globally. There is also a focus on the longer term and developing products that can bring sustainable profits.” So if Chinese manufacturers are already doing this, is there still an opportunity for Western companies? “Absolutely,” says Stephen Knowles. “This change in attitude is a great opportunity for Western companies who have design processes, creativity, quality and products developed to meet stringent international standards. However, the greatest challenge lies in understanding these markets, which are so different to the West and adapting or developing products to meet the local market needs. As is the case with best practice design, companies need to thoroughly research and test – there is no general approach when it comes to emerging markets.” At the simplest level there is a cost challenge – products for emerging markets have to be more competitively priced and offer good value. Manufacturers also need to understand the different practice and behaviour of these medical markets, which very often determine a dif-ferent product strategy to the equivalent product in a Western market. The way healthcare is managed in the community also varies greatly and is dependent on the education of patients – this all needs to be factored into the design. “We have a seen a lot of manufacturers who have successful products in Europe and the US but have failed to take them into China. By working between IDC in the

UK and Shanghai we are able to research and understand the market, to develop products that fit each unique requirement. One good example of the different market needs between the West and China is a project that IDC worked on for a disposable surgical stapler. The client’s product was a market leader but had been unsuccessful in China. By thoroughly researching the market, we learned that with cheaper labour in China, there isn’t such a requirement for disposable products as there is in the West and there is a preference for reusable surgical tools that can be easily sterilised by the workforce. With this knowledge we could take the existing product and adapt it to suit. So we turned it into a stapler that could be reused, with a more stream-lined shape to maximise cleanliness and used the best materials for autoclave sterilisation. The product then matched what the market needed, with the benefit of better design and overall quality,” explains Knowles.

Differing regulations Western companies may assume that if their products have the highest global regulatory standards they will be acceptable in all markets. But some emerging markets, despite much lower standards of regulations, still require their own regulatory standards to be met. As a guideline for India, if products have CE approval, this is usually a sufficiently high level for products to be acceptable. China requires that products meet CFDA approval which can be more demanding – even products with CE approval may not receive CFDA approval and it is advisable to have a local partner on the ground to manage the approval process. Neverthe-less CE approval is always well regarded in these emerging markets as it is seen as an in-dependent stamp of good quality. YiFei Dai emphasises how tough it can be working to balance all these requirements: “The user needs are often initially not well defined and we are working in a market that is very brand-conscious, so even when developing lower cost products, we still need to ensure an image of quality.” Despite the challenges that emerging markets present, IDC firmly believes there are huge opportunities for Western companies looking to develop medical products for China, India and other emerging markets. With populations of over a billion people and a change in life-style and diet that is leading to an increased incidence of medical conditions such as diabe-tes, the West has much medical support to offer China, India and other emerging markets.

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REGENERATIVE MEDICINE

FREEZE FRAME R

esearchers have synthesised a polymer that limits ice crystal growth in frozen red blood cells as it thaws. The polymer is set to pave the way for similar synthetic structures that mimic the properties of natural antifreeze proteins.

Antifreeze proteins have been a hot topic since they were first discovered in Antarctic fish in the Thadchajini 1960s. They have a wide range of potential in aerospace, the food industry Retneswaran, applications and in biomedicine, where they are used in the Royal cryopreservation.

Society of Chemistry, looks at an antifreeze polymer that protects cells as it thaws

During cryopreservation, cells and tissues are stored at sub-zero temperatures and thawed before use. However, frozen cells can be damaged as they defrost. When ice melts, it can refreeze into larger crystals that puncture cells from the outside. This process, called recrystallisation, is especially damaging for organs and blood bags, which defrost over a long time. “If you directly freeze cells they don’t survive due to iceinduced damage, and the traditional solution is to add antifreeze solvents [such as glycerol or dimethylsulfoxide (DMSO)]. Although these work, they involve complex preparation procedures, and transfusing large volumes of solvent is not desirable,” explains Matthew Gibson, whose team at the University of Warwick, UK, synthesised the new antifreeze polymer. Robert Ben, who specialises in ice recrystallisation inhibiting cryoprotectants at the University of Ottawa, Canada, comments that “alternatives to the conventional cryoprotectants are urgently required as the fields of regenerative medicine and tissue engineering continue to advance”. Unlike proteins, which need to be extracted or expressed in microorganisms, polymers are more accessible, processable, tunable and cheaper. Gibson’s group modified an already available polymer called a polyampholyte, which is composed of monomers with both positively and negatively charged groups. The polymer functions outside the cells, so it can be washed-off after thawing. This may explain its good compatibility with red blood cells. Up to 60% red blood cell recovery after freezing was observed during slow thawing when the new polymer was used,

and this increased to 80% when the cells were thawed quickly. Notably, the polymer was capable of inhibiting ice recrystallisation by 50%. Gibson admits that the mechanism by which the synthesised polymer inhibits ice recrystallisation is still not clear. Although it has been assumed for many years that macromolecules had to bind directly to ice crystal faces to inhibit growth, their work supports the idea that binding to ice crystals is not essential. “It seems that they somehow disrupt the rate exchange of water molecules between ice crystals, via the quasi liquid layer, although we do not have direct evidence for this at the moment. As to why the ampholyte structure works, we are not sure, but we are thinking that it might be a semi-rigid polymer due to charged interactions along the backbone, which helps.” “Cheap, non-toxic, degradable polymers that inhibit ice recrystallisation may become attractive non-permeating additives for cryopreservation of red blood cells if these boost cell recovery by more than 80% and allow for prolonged post-thaw storage. Such polymers have not yet been licensed or introduced into clinical practice,” states Ilja Voets, whose group at the Eindhoven University of Technology, Netherlands, is also interested in engineering synthetic polymers with anti-freeze properties. The results support earlier findings that ice recrystallisation inhibition is a desirable property for cryopreservation enhancement, rather than the polymer acting directly on the cell. More importantly, Gibson thinks that their findings ‘highlight the need for new technologies to address the challenges of an ageing population – for regenerative medicines (eg those based on stem cells) to be exploited, we need to enable the banking, and distribution of the new tissues, which we feel our materials can contribute to.’ He believes that “ice recrystallisation inhibition could be ‘dialled in’ to a range of molecules and polymers if we can understand how they function. It goes without saying that we are very excited about the future of these materials.”

Matthew Gibson won the Royal Society of Chemistry’s Emerging Technologies competition in 2014 with this research. This article was reproduced with permission of Chemistry World, the Royal Society of Chemistry

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INJECTION MOULDING

If the cap fits: The coloured caps are an important functional element of the blood collection tubes. They ensure easy identification in the lab

Performance art A

n internationally active manufacturer of diagnostics aids was using several Netstal machines. Still, the new order was a first: “The customer made the leap from buying machines to purchasing a system,” said Patrick Blessing, manager of the medical technology Medical technology business unit, in describing order. “Previously, they applications place high the only purchased the machine, demands on injection added the peripheral moulding machines and equipment and combined the production line. everything into a production However, the realisation Top performance can line. has set in that purchasing only be achieved with the entire system from a sophisticated technology specialist is less expensive and detailed process in many regards.”

know-how, says Netstal

In order to manage everything on a do-it-yourself basis, the user has to keep their own expensive specialists on staff and also make sure that software and hardware are always up to date. They have to cobble together interfaces and often compromise in ways that result in their system constellations operating far below their potential. And even a minimal degree of standardisation (which this customer aimed for) is very difficult to achieve based on these premises. And it all costs money.

“Nowadays we mainly sell complete solutions based on customer specifications. The customer no longer has to worry about the interaction between machine and peripheral devices and can instead task us with performing the configuration and fine-tuning,” Blessing emphasises. “But that doesn’t mean at all that they don’t have a say in designing the system. Each system is built in close and continuous cooperation with the user.” For this reason, Netstal’s ‘one team per customer’ rule applies. From the first meeting until the system is approved, the customer will always deal with the same two or three competent employees, regardless of whether they are in Europe, the US or elsewhere in the world. They know the project and understand the goals of the user. The expertise for the details of the definitive solution is always at the ready at Netstal’s headquarters in the Swiss town of Näfels. “We provide a broad knowledge base and a wealth of experience there,” Blessing explains. “That goes well beyond mechanical engineering. Our core competence of developing and building high-performance injection moulding machines has long been joined by another: the integration of a wide variety of components, which were not built by Netstal, into an optimised overall system. In that way, we are providing our customers with real added value.”

INJECTION MOULDING

The goal of producing 96 stoppers per injection mould and injection process with cycle times of less than five seconds was particularly ambitious. To get straight to the point: “With 3.8 seconds, we beat that target by nearly a quarter even in the internal Netstal final acceptance test,” Blessing said. “That cycle time might even be reduced further once the customer runs the system in regular operation. Such performance values can only be achieved with an optimal integration of all components.”

Take the tube: Blood tubes made of transparent PET

When looking for an injection moulding system supplier that could provide an ‘all-inone’ system, the customer found Netstal. The Swiss company was awarded the contract for building a complete system for the production of stoppers for blood collection tubes. Such tubes, made from PET (polyethylene terephthalate), are used in doctors’ offices, hospitals and laboratories in order to be able to get quick diagnostic results. They generally contain chemical additives and a defined vacuum that ensures the correct mixing ratio between the blood that was collected and the chemicals. They are sealed with plastic stoppers. The stoppers, made from colored PP (polypropylene), are the final closures and shield these ‘miniature laboratories’ from external influences. Their colours are used to safely distinguish samples. The new system for stopper production was supposed to consist of an injection moulding machine and multiple components from other manufacturers: a quality control gate, a conveyor system and a carousel packaging station. Two important additional requirements had to be adhered to during the design phase. Firstly, no stoppers were allowed to be dropped to the floor during the process. Secondly, the limited space in the production area had to be considered. In addition, the Mouldflo units provided by the customer (for the flow and temperature control of the injection mould cooling) had to be installed and integrated into the process.

An ELION 4200-2000 high-performance injection moulding machine with a 62 LP screw is the heart of the system. In order to control it – and all other elements of the production line – Netstal counts on a pioneering system: the aXos machine controller, which is a perfect integration tool. It has a firm grip on all processes in the blood collection tube system – from material feeding to the actual injection moulding process and its cooling, the quality control gate and the air delivery system including the reject gate all the way to packaging on the carousel. As opposed to most other controllers, aXos not only controls and monitors the machine but it also allows programming while in operation. When it was developed, Netstal’s engineers wanted to provide programmers with maximum flexibility when drafting complex processes without requiring them to have extensive programming knowledge. The result is a programmable controller that provides operators with maximum flexibility – as long as their commands do not damage the machine. “While the controller on its own provides many options, only a detailed process and component know-how stretching across all production steps allows for the true fine-tuning of the entire system,” Blessing said. “And we can reach the kind of cycle times and therefore the performance as in this case, as well as many others, when we get close to reaching the optimum during the integration process.” The customer seemed to agree – and placed additional turnkey orders.

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POLYOLEFINS

MATERIAL GAINS

he use of plastics in healthcare applications continues to increase as the rising costs from spiralling healthcare demand need to be managed by governments, companies and individuals on a global basis. Whether it be moving from non-plastic materials like glass or metal or the iterative James Stern, Borealis upgrade of materials as the Healthcare, looks at new generations of medical broadening horizons devices are developed, for the healthcare polyolefins are increasingly being used as an alternative industry through use of material due to their polyolefins combination of excellent property profiles and good value in use. Today, polyolefins are an integral part of many pharmaceutical packaging solutions such as container and closure systems. They are also widely used in medical devices such as drug delivery systems, syringes, MDPIs or nasal sprays and devices involved in surgery from bowls and handles through IOL components, sheaths for protection whilst manipulating New thinking: According to Borealis Bormed SB815MO is an innovation in soft PP addressing some of the most pressing challenges in the healthcare industry

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devices for sensitive repairs (eg meniscal tears, tracheoesophageal puncture) to the associated packaging often used to maintain sterility. The use of plastics in healthcare applications continues to increase, even against a backdrop of ever increasing regulatory oversight, economic volatility and customer sensitivity. In order to continue to be a key material of choice, however, the producers of such materials need to undergo a number of paradigm shifts in how they manage the production of their materials destined for use in healthcare applications. They must not only understand the requirements of the healthcare/ pharma industry, but practically translate them into what is possible within a chemical industry traditionally producing materials for applications needing less material control and thus manage the regulatory focus that is moving deeper and deeper into the supply chain.

In order to offer medical device and pharmaceutical packaging producers extended confidence that the material they qualify for use today will be the same material they can use for years, polyolefins need to be supplied with a strong service support package that addresses the needs of the healthcare industry. For example, this means providing a recipe/formulation lock-down commitment, extended notification of change period as well as appropriate pharmacopeia testing results and FDA DMF registration. This additionally secures the investment in material qualification and means any final item testing remains relevant because if the material should change, for example, the recipe, production location or production technology, it is highly likely that testing needs to be renewed as the interactions between these materials and any drugs, bodily fluids or tissues is critical. Timely and accurate communication of what has changed allows for a risk assessment of potential consequences and should be considered an essential part of the service package. Should these materials change without notice, all the information developed has little value as no risk assessment of the change will have taken place further down the supply chain. Whilst testing such as extractable profiles and interaction studies fall under the aegis of the pharmaceutical companies and need to be completed on the final article, it is important that the suppliers of such materials strictly control the material compositions to minimise any unforeseen changes once the studies have been completed. Reacting to strong driving forces for performance improvement and increasing regulatory pressures, new polyolefin materials have been developed. These solutions provide innovative material properties whilst increasing production efficiency of pharmaceutical packaging and medical devices. Reduction of costs and matching regulatory requirements with a reduced environmental footprint are further up-side potential benefits from their use in new applications. Borealis, a provider of innovative solutions in the fields of polyolefins, base chemicals and fertilizers, launched one such polyolefin material in 2013, Bormed SB815MO, as an extension of its family of Bormed polypropylene (PP) material specifically tailored to healthcare packaging applications.

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MEDTECH IRELAND

Dublin up This October sees an array of Irish medical technology and healthcare companies heading to Dublin for Med in Ireland. MPN looks at what’s on offer from the Irish medtech scene

ctober sees Med In Ireland taking place at the Convention Centre, Dublin. The event is Enterprise Ireland’s largest medical technologies event and is billed as a high-profile showcase for the whole of the Irish medical technologies sector - medical devices, medical devices sub-supply, precision engineered components, diagnostics, connected health, healthcare providers, clinicians and research and development professionals. Organisers of the event says that the top medical technology and healthcare companies, clinicians and healthcare systems from around the world will be at the event to develop strategic relationships with Irish companies exhibiting at event. The Irish medtech sector has grown strongly over the last 20 years demonstrating sustained innovation and growth in international markets. Ireland is home to more than 350 medical technology companies, including 13 of the top 15 global medtech companies, employing 25,000 people and exporting almost €8bn. Ireland is now the second largest exporter of high tech medical products in the EU and is internationally recognised as a location of choice for development and manufacture of high tech products.

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MEDTECH IRELAND

According to the Irish Medical Devices Association, the medical technology sector in the country is recognised as one of the five global emerging hubs. It boasts that 18 of the world’s top 25 medical technology companies have a base in Ireland and 50% of the 300 medtech companies based there are indigenous. According to the association, the Irish government’s investment in R&D through Science Foundation Ireland over the past five years has seen the country grow its medtech facilities research. This include Ireland’s first stem cell manufacturing centre in Galway and an initiative between Enterprise Ireland and the Mayo Clinic. The USA will commercialise up to 20 novel medical technologies in Ireland over the next five years to creating several high value medical technology spin-out companies. Earlier this year Ibec, the group that represents Irish business, hosted a manufacturing conference in Galway. It found that economic trends, including the weak euro, had put Ireland in an increasingly attractive position as a manufacturing base. These findings highlighted that there was now an opportunity to reverse the demise in manufacturing that occurred during the boom years. Between 2008 and 2012 a lack of competitiveness meant domestic manufacturers struggled to compete, the number of Irish companies fell by 20% and employment fell by 23,000 in the sector. Speaking at the event, director of the Irish Medical Devices Association (IMDA) Dr Sinead Keogh said: “We are now seeing a real opportunity for recovery. Output in traditional manufacturing was up 6.3% in 2014, and Irish goods are competing strongly with UK counterparts. Employment in manufacturing will be 6,000 higher this year compared with last. “However, more can be done to help the sector. Irish companies need more support to make it big and attract investment. Skill shortages are emerging in certain sectors and these need to be urgently addressed. Business needs to work closer with education and training providers and as part of the ongoing reform in apprenticeships, new apprenticeships in manufacturing need to be developed. The government must also ensure the knowledge development box fully reflects how R&D in the sector leads to new developments in innovation and new products.” Ibec head of business sectors, Sharon Higgins, said: “Manufacturing is an integral part of the Irish economy and is the second largest employer with 4,000 businesses, both homegrown and international, employing nearly 160,000 people. It can help Ireland achieve a balanced and sustainable recovery, with as many as 82% of manufacturing employment already outside of Dublin, but only if the conditions are right.”

Med in Ireland At Med in Ireland 2015 a range of Irish medtech companies will exhibit and be available for one-toone meetings. Visitors to the event will be able to network with a range of exhibiting Irish companies as well as gain an insight into the

The

trends in the medtech sector via the event’s keynote speakers. There will also be an opportunity to learn about clinical design innovation and find out about Irish medical technologies being developed through Horizon 2020 funding – the €79bn EU fund for research and innovation.

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ADHESIVES

Stick with it W

hile the automotive and aerospace sectors have historically pushed forward innovation in the adhesives sector, the medical market should not be overlooked with increasing technological advancement taking place in this area. Performance is of course key and as the need for quality medical adhesives becomes ever more important, many manufacturers are looking at this market with interest and producing products that meet the challenges the medical sector demands. As medical devices become smaller and more lightweight, the trend for adhesives to match this innovation has followed. Device manufacturers are looking to replace fasteners while the materials being used to make these products are becoming more complex requiring a re-think of the adhesive being used to both complete a device and also where necessary, to attach the device to an individual.

Trend setters

As medical device design continues to innovate and push forward the boundaries of design and technology, the role of adhesives is changing. Product manufacturers are following suit with formulations that meet the latest needs of today’s devices. By Lu Rahman Hair today: NanoGriptech has produced a geckoinspired adhesive, Setex, that it says is the world’s first dry adhesive inspired by the microscopic hairs of a gecko’s foot

Certain trends in the adhesives sector are beginning to emerge and in the medical sector there is an increasing requirement for products that stick to silicones, for example. The wearables sector is becoming highly significant requiring the development of multimaterial adhesives for these layered products which can include touch panels, lights, cameras and of course electronics. They use many different materials and therefore the choice of adhesives becomes more complex.

As traditional methods of fastening such as welding or screwing become harder to use due to the more complicated nature of the components in modern devices, adhesives are really having to come to the fore. Lightweight products using carbon-fibre reinforced plastics make adhesives the only viable way to join as drilling is no longer an option. And for this reason, the choice of adhesive is becoming an early consideration in a product’s design process. The global adhesives market offers much potential – this year it has been estimated to be worth $11,339.66 million and is projected to grow at a CAGR of about 4.88% between 2015 and 2020. The biggest and fastest growing region is currently the Asia-Pacific with growing demand for adhesives in India, China, Japan, South Korea, and Australia. North America is still also a significant space for medical adhesives.

Industry bonding DuPont has been working closely with medical display manufacturers for some time offering optical bonding technology to this sector. The company recognises that medical applications require mobility and reliability features in LCDs and that they also present demanding challenges such as ambient lighting conditions, shock, vibration, sterile environmental requirements and constant temperature changes. The company’s Vertak bonding technology has been developed to offer a range of benefits 36

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Polymer perfection powered by

passion

Sticking point: Device manufacturers are looking to replace fasteners while the materials being used to make these products are becoming more complex requiring a re-think of the adhesive

including resistance to stains, dirt and moisture, durability to withstand shock and temperature change and also enable thinner and lighter display designs. Other companies involved in medical adhesive technology include Eastman Chemical Company, Evonik and DOW Chemical Company.

Get a grip NanoGriptech is another company pushing forward innovation in this field. Strange as it might sound, the company has produced a gecko-inspired adhesive, Setex, that it says is the world’s first dry adhesive inspired by the microscopic hairs of a gecko’s foot. The technology is being put forward as a solution to a range of medical applications and is said to offer friction enhancement to skin. The company says that current gripping material used on orthotics, braces, prosthetics, face masks and other medical equipment that comes in contact with skin often slip, become contaminated or use materials that smell over time. Such materials do not work well with concave surfaces or in situations that need low profile, non-tacky gripping. NanoGriptech says that Setex offers an alternative in this area.

and

know-how

The technology can also be used for surgical tool grip. The current challenge is surgical tool design is to create tools that improve grip without tacky contaminants or adding profile that decreases touch-sensitivity and NanoGripTech says this technology enables surgical tool providers to create sterile tool grips improve gripping performance, without residue or bulkiness. NanoGriptech was founded by Metin Sitti, a professor of mechanical engineering at Carnegie Mellon university in the US, who worked for nearly a decade to understand and synthesise biologically inspired micro/nanostructured adhesives. “Much like Velcro or Kevlar, we believe Setex will disrupt markets because of its many commercial applications. Setex is residue-free, strong and reusable,” says Roi Ben Itzhak, NanoGriptech CFO and vice president of business development. “There are other gecko-inspired materials in labs around the world, but, unlike Setex, they have all have weak peel strengths and are prohibitively expensive to manufacture.” Setex’s glue-free fibres mimic the adhesive qualities of gecko foot hair. Intermolecular forces found at the tips of the hairs enable geckos to walk across ceilings. Like a gecko’s foot, Setex can be applied to a variety of surfaces and lifted repeatedly. The synthetic fibres are strong – several square inches of Setex will support hundreds of pounds. NanoGriptech researchers can customise their manufacturing techniques at the microscale level to produce materials that are modified for different applications, such as enhancing a robot’s ability to pick up a part or improving the fit of prosthetic limbs on skin.

visit us at our stand 515 October 6-7, 2015 Radisson Blu Hotel, Galway

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EXTRUSION

Smart thinking A

breakthrough technology for extrusion dies enables manufacturers of thermoformable sheet for medical and pharmaceutical packaging to make thickness changes in minutes rather Sam Iuliano, chief than hours, extend the range of that they can produce technologist, Nordson EDI, thicknesses and achieve these improvements explains how new sheet die while enhancing sheet quality and technology can enhance consistency.

quality and consistency of medical packaging

The quality improvements resulting from the new technology are the result of more uniform polymer orientation in the sheet and lower residual stress. They are particularly important for preventing warpage when the plastic is heated during sterilisation. In general, enhanced quality and consistency make the sheet more readily thermoformed into blisters, trays,

Mind the gap: A Nordson EDI sheet die equipped with SmartGap mechanism.

and procedure kits, more resistant to defects that can compromise the sterile barrier and less prone to streaks and other appearance problems in applications that demand excellent clarity. Called SmartGap, the new, patent-pending system uses a single-point adjustment mechanism that changes the lip gap while simultaneously modifying the length of the lip land to provide the most appropriate conditions for the newly adjusted thickness as the sheet exits the die. The lip land is the final gap in the die that forms the lip exit. By mechanically linking the adjustment of these two key process variables for the first time, the SmartGap system ensures a proper set-up of the die and takes substantial time and guesswork out of the process for achieving desired sheet properties. The system, available only on new dies, eliminates the extended shutdowns for changes in lip components that have often been necessary when transitioning to new job runs, reducing to a matter of a few minutes changeovers that used to take two hours or more. Also overcome are previous limitations on thickness range caused by the complexities of die modification; the system readily encompasses die gap adjustments over a range of 0.400 in. (10.2 mm), enabling processors to efficiently run with multiple product changes per day.

Simultaneous adjustment of lip land and lip gap Operators set the thickness-change process in motion by using an adjustment mechanism at the end of the die to make a new setting for the lip gap. Simultaneous change in the length of the lip land automatically takes place on an as-needed basis, depending on the target sheet thickness. Thus, for thin sheet, the lip land is short, which helps to control back-pressure at smaller die

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International exhibition and conference on additive technologies and tool making

Frankfurt am Main, 17 â&#x20AC;&#x201C; 20 November 2015 formnext.com

Innovations. Impulses. Inspiration. The worldâ&#x20AC;&#x2122;s leading companies in additive manufacturing technologies and highly specialized tool-making will show you their expertise at formnext powered by tct. Discover how additive technologies can be intelligently combined with conventional procedures in product development and production, and how you can use innovative processes to reduce your time to market even further. New potential across the entire manufacturing process is waiting to be discovered by you. We are looking forward to seeing you!

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EXTRUSION

Singled out: Close-up of SmartGap single-point adjustment mechanism

gaps, reduces deflection, and lessens the need for draw-down. For mid-range sheet, the lip land changes from short to medium length, providing sufficient pressure for effective adjustments to the flexible lip of the die while helping to reduce swelling of the extrudate. For thick sheet, the lip land is extended to full length, increasing back pressure at large lip gaps and helping to reduce extrudate swell. Previously there have been two methods of varying the lip gap. The simplest was to adjust the flexible upper lip of the die. This has a limited range of gauge variation, or ‘travel’, requires several adjustments across the width of the die and necessitates an extended shutdown period to exchange a removable lower or fixed lip to effect a step-wise change in both lip land and lip gap. A more recent method involves use of a singlepoint adjustment system to bend the fixed lip, extending the range of travel but without providing for change in the lip land—so that the lip land used is a compromised design of medium length. Bending die lips over significant distances results in lip lands that are not parallel, causing undesirable diverging or converging flowpath geometry. This can exacerbate certain problems such as lip contamination that leads to streaks. When there is either no provision for a lip land change or lip land change procedures are too time-consuming, processors will often struggle with sheet quality. This is especially true at the thinner and thicker extremes of their product range, where a medium-sized lip land is less appropriate.

Improvements in sheet quality and consistency In addition to avoiding extended shutdowns and broadening the available thickness range, SmartGap technology aims to provide these advantages:

Avoiding excessive sheet shrinkage. Since it is now convenient to set smaller lips gaps, processors do not need to draw down as much to achieve target gauge. As a result, there is less orientation of the sheet and, subsequently, fewer problems with shrinkage. Tighter tolerances and better lay-flat sheet. Now that more appropriate lip land lengths are available for small and large lip gaps, use of the flexible lip to fine tune the gauge profile is now more effective. In addition, a proper lip land to lip gap ratio prevents excessive extrudate swell, which causes visible corrugation defects. Improved lip geometry also yields a more fully developed flow, which results in more uniform orientation and less warpage. Better appearance. Reduction in extrudate swell helps to avoid streaks and reduces the tendency of lip faces to become contaminated. Defects from running with a die gap that is too small, such as ‘shark-skin’, can be avoided by using systems that provide good thickness control at larger die gaps. Improved external deckle performance. Since the SmartGap system slides the lip components, instead of flexing them through an arc, the lip lands will remain parallel and the lip faces remain flush and normal. This keeps the lip geometry ideal for use with external deckles since the deckle seals do not need to conform to irregular lip faces. The result is that external deckles seal better and require less maintenance. SmartGap technology can be employed with most of the polymers typically used in medical and pharmaceutical packaging, such as polystyrene and high density polyethylene. Ultimately the quality benefits that it provides translate into packaging that is safer, more reliable, and better looking. Size matters: SmartGap system adjusts lip land as lip gap changes to accommodate thin sheet (left), mid-range sheet (centre), and thick sheet (right)

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FAKUMA

Part of the process O ver the last 30 years the Fakuma trade fair has become a key event for the plastics processing sector across the globe.

Fakuma offers a forum of innovation in plastics processing. MPN picks out some of the medical highlights of this year’s event

The event - which takes place in on 13-17 October, Messe Friedrichshafen – will feature the latest technology from around 1,700 exhibitors. It will cover a range of technologies including injection moulding, extrusion and thermoforming and for the medical plastics sector, there is a wealth of innovative technology being shown highlighting the expertise in this sector.

Fast and furious Sumitomo (SHI) Demag will be showing its El-Exis SP 200, a machine with short cycle times for injection moulding and automation. This high-speed machine produces four 125 ml polypropylene containers and completes their removal by a special handling robot in less than two seconds. Together with partners Brink – for the automation and the mould – and Borealis – for the polypropylene (PP) – Sumitomo says this is an excellent system for producers of plastics packaging products looking to optimise highspeed production line

Sealing the deal Elasto has expanded its range of Mediprene TPE compounds for plunger seals in single-use syringes. The new grades will be among the materials showcased at Fakuma.

Niklas Ottosson, medical technical manager for Elasto, said: “Over recent years there has been a rise in demand for single-use syringes and a clear move from rubber to TPE for plunger seals. To support this growing market, we have expanded our range of Mediprene TPEs specifically designed for syringe plunger seal applications.” Mediprene grades are sterilisable with gamma, EtO and steam and representative grades have passed cytotoxicity tests according to ISO 10993-5 and biocompatibility tests according to USP Class VI. The Mediprene materials are latex free, which reduces the risk of allergic reactions. Mediprene TPEs are resistant to many fluids used in the healthcare environment. Elasto is offering these grades as translucent or coloured compounds, made from medical grade raw materials. The colour masterbatch supplier has been selected with care, ensuring that the pigments and carriers are compliant and are manufactured under rigorous controls with regard to traceability, consistency and change control.

Focal point This year, Albis Plastic will be at Fakuma, where one of its core focus industries will be healthcare. The company will be demonstrating its product portfolio which includes both distribution and own brands as well as highlighting the latest examples of tailor-made applications. Hanseatic, distributor and compounder will also be presenting the rebranding of Altech its own brand product series. Produced with recycled raw materials, Altech will now be known as Altech Eco. With this product, Albis offers high-grade, sustainable compounds, which it says

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Laser Plastic Welding

are virtually equivalent to comparable new goods and even offer a slight price advantage. Albis will also be using Fakuma to determine trends in individual core industries, launch collective projects and discuss cooperative efforts in the target markets together with its customers and partners.

All-round winner Arburg’s medical exhibits at Fakuma will include its electric Allrounder 470 A where it will show a clamping force of 1,000 kN producing y connectors for an infusion therapy device using an eight-cavity Männer mould with a cycle time of approximately 15 seconds. An extended conveyor belt with a tunnel cover for docking with the cleanroom will also be on show. Arburg says that placing the machine and equipment outside the cleanroom leads to more cost-effective operation.

Opportunity knocks The DuPont stand at Fakuma will show how its Zytel nylon material, coupled with its material portfolio and computer aided engineering (CAE), process simulation can continue to create new growth opportunities in a range of industries, including healthcare. Michel Renaud, head of design for Europe, Middle East and Africa (EMEA), at DuPont, said: “DuPont works with customers throughout the product development cycle, continually advancing materials, supporting design and optimising for processing and is helping customers predict how our materials will perform from art-to-part.”

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Reliable, Clean, Economic LPKF’s production solutions – success through experience.

Fakuma: October 13 – 17, 2015, Friedrichshafen, Hall A4, Booth 4219

LPKF Laser & Electronics AG 90765 Fürth Phone +49 (911) 669859-0 www.lpkf-laserwelding.com

BUYERSGUIDE Orthopaedics

Polymers

Sil-Pro  (001) 763 972 9206  740 Seventh Street, South Delano, Minnesota, MN55328, United States

Distrupol Limited  (0031) (0)78 6250150  Noordweg 3,Postbus 11, AA Zwijndrecht, 3330, Netherlands

Elasto UK Ltd

Sunstar Degradable Solutions AG  (0041) 43 433 6200  Wagistrasse 23, CH-8952 Schlieren, Switzerland

 (0044) (0)161 654 6616  Don Street, Middleton, Manchester M24 2GG, United Kingdom

Invibio Ltd

Packaging Eastman Chemical B.V.  (0031) 10 2402 111  Fascinatio Boulevard 602-614, 2909 VA Capelle aan den IJssel, The Netherlands

Herrmann Ultraschalltechnik GmbH & Co.  (0049) 7248 79-729  Descostrasse 3-9, Karlsbad, D-76307, Germany

Nelipak Healthcare Packaging  (00353) 91 757 152  Unit 6D, Mervue Business Park, Galway, Ireland

PEEK & High Performance Polymers

 (0044) (0)1253 898000  Technology Centre, Hillhouse International, Thornton Cleveleys, Lancashire, FY5 4QD, United Kingdom

Melitek  (0045) 70 250 255  Hartvig Jensensvej 1, Nr. Alslev, DK-4840, Denmark

Polyurethanes DSM  (001) 510 809 1232  2810 7th Street, Berkeley, California, CA 94710, United States

Foster Corporation  (001) 860 928 4102  45 Ridge Road, Putnam, CT 06260

Formulance

 (001) 847 596 3100  1425 Tri-State Parkway, Suite 120, Gurnee, Illinois 60031

 (0033) 967 30 6463  Tour Oxygene, 10-12 boulevard Vivier Merle, 69393 Lyon Cedex, France

Zeus

Lubrizol Advanced Materials

Teleflex Medical OEM

 (001) 803 268 9555  3737 Industrial Blvd., Orangeburg, South Carolina, SC 29118, United States

 (001) 216 447 6782  29400 Lakeland Boulevard, Wickliffe, Ohio, OH 44092, United States

Polymers

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RIGHT MATERIAL

Medically compliant polymers from Distrupol Be expertly guided to your polymer solution with Distrupol. To discover more about our medical range please contact us today. info@distrupol.com +44(0)1932 566033 www.distrupol.com

The leader in custom polymer technology for medical devices, implants and drug delivery applications Radiopaque · Low Friction · Antimicrobial Bioresorbable · Drug Eluding · Resin Distribution P 860.928.4102 • info@fostercomp.com

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Polyolefins Specialist in Elastomers and Polymers for Healthcare

MELITEK is dedicated to production of meliflex elastomer and polymer compounds specially designed and produced to meet rigorous requirements of medical applications and healthcare users.

meliflex is produced at our state of the art high efficiency plant in Denmark and is based on over 30 years’ experience in servicing medical and pharmaceutical industry with advanced technologies.

The meliflex elastomer and polymer compounds offers customized solutions based on wide range of prime polymers including PE, PP, COC, TPE, TPO, TPV, SBC, ABS, PS.

We add value by creating value!

The meliflex materials offer: -

Compliance to ISO 10993 and USP 88 (class VI) requirements No phthalate plasticizers, PVC, BPA, latex, animal based additives Wide range of shore hardness (Sh 10A – 75D) Extensive medical service concept; full traceability, change control, line clearance, segregated production, etc. - Customized materials on colour and functionality - Cost efficient alternative to soft PVC, TPU, Silicone

Hartvig Jensensvej 1 • DK-4840 Nr. Alslev • Denmark • www.melitek.com Tel: +45 70 250 255 • Fax: +45 70 250 277 • E-mail: sales@melitek.com

Meet MELITEK at CPHI 2015 in Madrid - Stand 4B20

Seals

TPE

Trelleborg Sealing Solutions Germany GmbH  (0049) 711 786 40 Handwerkstrasse  5-7, DE-70565 Stuttgart, Germany

Sterilisation Sterigenics  (001) 704 947 2505  2015 Spring Road,Suite 650, Oak Brook, Illinois, IL 60523, United States

Tubings Formulance  (0033) 967 30 6463  Tour Oxygene, 10-12 boulevard Vivier Merle, 69393 Lyon Cedex, France

Microlumen  (001) 813 886 1200  One Microlumen Way, Oldsmar, Florida, FL 34677, United States

Polyflon  (0044) (0)1785 859054  16 Raleigh Hall, Eccleshall, Stafford, ST21 6JL, United Kingdom

Qosina  (001) (631) 242-3000  150-Q Executive Drive, Edgewood, New York, NY 11717-8329

Vention Medical  (001) 508 597 1701  261 Cedar Hill Street, Marlborough, Massachusetts, MA 01752, United States

Zeus  (001) 803 268 9555  3737 Industrial Blvd., Orangeburg, South Carolina, SC 29118, United States

TPE for Medical Applications www.mediprene.com mediprene@elasto.se

BEADY

The personal TOUCH

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 . . .

MPN: Who are you and what do you do?

RCT: Episurf Medical is a medical device company, the first in the world to develop a patient- specific joint resurfacing treatment. The company is based in Stockholm, Sweden, with subsidiary offices in the United Kingdom and Germany. By combining advanced 3D-imaging technology with the latest manufacturing technology, we adapt each implant to the patient’s unique injury and anatomy, as well as customising the surgical instruments. In doing so, we enable surgeons to offer Rosemary Cunningham a personalised Thomas, CEO, Episurf, treatment to help explains what’s so special alternative patients with joint about the company’s joint injuries, return to resurfacing treatment active lifestyles.

MPN: What projects have you been focused on recently?

RCT: Episurf Medical’s core competence lies within the process of developing patientspecific treatments for joint damage repair. A technology based on a portfolio with some 80 patents and patent applications in areas such as image processing, patient-specific implant systems, patient-specific surgical techniques, patient-specific surgical tools and manufacturing for any joint in the human body. Our main focus is on the Episealer product range, developed for treating focal cartilage lesions and underlying bone defects in the knee. The Episealer is an individuallytailored endoprosthesis, delivered together with Epiguide, a patient-specific drill guide, and a personalised surgical toolkit. The entire process of creating patient specific implants and surgical tools is done within the

Similar to Episealer Condyle Solo and Episealer Trochlea Solo, Episealer Femoral Twin is patientspecific and is delivered together with a dedicated Epiguide and surgical toolkit.

MPN: What does it mean for the medical sector?

framework of the company’s proprietary web based system. It enables day-to-day interaction with orthopaedic surgeons all over the globe and provides guidance for surgeons through the entire process; from 3D visualisation of the joint, comprehensive damage assessment, surgical planning, design and manufacturing of implants and surgical tools to the surgery itself. The system ( iFidelity) enables endoprotheses to be cost-efficiently tailored to each individual’s unique anatomy and injury for the optimal fit and minimal intervention.

MPN: Describe your latest innovation?

RCT: Our current products, Episealer Condyle Solo and Episealer Trochlea Solo are indicated for focal cartilage lesions and underlying bone defects for up to 20mm in the knee condyle and 30mm in the knee trochlea. Our latest addition, Episealer Femoral Twin, can be used to treat injuries up to 35mm in length, in the knee condyle, knee trochlea or both. As the name suggest, it is an endoprosthesis consisting of two joined endoprostheses with a maximum diameter of 2x25mm.

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RCT: Episurf Medical bridges the gap between biological treatments and total/partial knee arthroplasty. This treatment gap is difficult to define age-wise, but refers to the time period when traditional biological treatments for focal cartilage lesions and underlying bone defects in the knee fail to give satisfactory results but the patient is still considered too young to undergo a total/partial knee arthroplasty. Episealer provides the physicians with an additional option to help this ever-growing group of patients among those who suffer from joint injuries. Through Episurf’s patientspecific approach, physicians have the possibility to decide pre-operatively if the patient is a suitable candidate for the Episealer procedure and thereby ensuring the best possible outcomes for each patient. The online process gives physicians full freedom to be collaborative in the damage marking and design process.

MPN: Plans for the future

RCT: Episurf is developing new products aimed at helping surgeons to perform more precise surgeries. The company is also looking into the possibilities of applying the implant technology to other joints.

11219 Tuohy Borst Adapter Small Body Flat Cap

91600 Needleless Injection Site Swabbable FLL, Non-Disconnect MLL

11184 FLL to FLL Connector with Wings

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80329 One-Handed Hemostasis Valve Y Connector Rotating MLL, FLL Sideport

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All trademarks and registered trademarks are the property of their respective owners

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