MPN EU Issue 20

MPN

MEDICAL PLASTICS NEWS

Where medical technology expertise meets customer satisfaction

ALSO IN THIS ISSUE: Focus on injection moulding Lab-on-a-chip — the expertise on offer Medical plastics at Interplas 2014

ISSUE 19 July-August 2014 WWW.MEDICALPLASTICSNEWS.COM

MPN Digital spy—Page 8

All Medical, All Plastics

Contents 5. Editor’s comment Down at the social Lu Rahman looks at the value of getting to grips with social media

Cover story—page 15

6. News analysis We look at: Medical device security The reprocessing of medical devices And the future of tissue engineered devices 8. Digital spy MPN’s new section with a digital angle to keep you on top of the latest trends

Design4Life—page 20

14. Market analysis Aleksandra Jones on the importance of plastics in ready-tofill syringes 15. Cover story Expertise from Netstal 17. Speech therapy Comment and opinion from the industry

Lab-on-a-chip—page 27 Injection moulding—page 29

22. Interplas With a medical focus you need to attend this flagship plastics event 27. Lab-on-a-chip Including expertise from Nano4u and Porex 29. Injection moulding A round-up of the latest developments from Engel, Ultrasion and Forefront 38. Ready-to-fill Gerresheimer under the spotlight 39. Testing & quality control ISO13485 41. Adhesives & fluids 42. Polyolefins Medical applications for polyolefin films from Polyzen 46. Beady eye This issue we put Payam Zachkani, University of British Columbia, under the spotlight

20. Design4Life Julian Swan, IDC, says ditch the red tape in the design process

Online and in digital Disclosure: Medical Plastics News charges an undisclosed fee to place a contibutor’s image and headline on the front cover.

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

JULY - AUGUST 2014 / MPN /3

EDITOR’S COMMENT

CREDITS

Down at the social

editor | lu rahman

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ith a few months under my belt now, there are a few things I’ve noticed about the medical plastics sector, one of which is that for many of you, social media isn’t high on your list of priorities.

Of course, time has a huge part of pay in this and it is currently in emerging sectors – such as renewable energy – that the need for regular Twitter and LinkedIn updates are seen as crucial. For established companies in established sectors, finding the person who has both the time and the inclination to master social media, can be extremely difficult. It is interesting to note though that Twitter’s fastest rising demographic is the 55-64 age group bracket – so it isn’t just for the younger generations.

For many people, social media is part and parcel of their everyday lives, especially for personal use. Carrying it across into a professional setting can be problematic for some people, keen to ensure it doesn’t undermine their professional standing. Of course, social media etiquette is vital but it should not detract from the valuable role the platform has to play in the working environment. And with 58 million tweets being sent each day, there is a definite value to being part of what’s going on.

With this in mind, it was interesting to read an article in the BMJ which highlighted the way social media, Twitter in particular, has become a key networking tool for healthcare professionals. For some time now both Facebook and LinkedIn have been used by groups of doctors as a way to network online. Last year, the Royal College of General Practitioners issued the Social Media Highway Code – guidance on how doctors can balance professional responsibilities with the use of social media.

The article highlights cases such as Stephanie deGiorgio, programme director for the general practitioner vocational training scheme for East Kent who says that in the short time she has been using Twitter, she has created a network of doctors to follow whose opinions she is interested in hearing.

The article also cites a clinical lecturer who uses it when attending conferences and lectures to find out more about who’s attending as well as another professional who says she finds it helps her form better connections at events with the people she has been following on Twitter.

It’s all very interesting but where does the medical plastics device sector fit into this?

With the doctors and the healthcare sector in general, being such big fans of Twitter, it’s only a matter of time before this enthusiasm filters back down the supply chain. Opportunities exist for many device firms to be creating relationships with potential business partners and boosting existing ones through the use of social media such as Twitter. The sharing of knowledge and opinion is crucial to the ongoing development of an industry and Twitter offers a quick and easy way keep on top of this, wherever you are in the world and whatever time zone you happening to be operating in.

an article in the BMJ highlighted the way Twitter in particular, has become a key networking tool for healthcare professionals

contributing editor | aleksandra jones advertising | mandy o’brien art | sam hamlyn publisher | duncan wood

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

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

© 2013 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.

BPA Worldwide Membership ISSN No: 2047 - 4741 (Print) 2047 - 475X (Digital) JULY - AUGUST 2014 / MPN /5

NEWS ANALYSIS

Cyber security for medical devices – are we doing enough?

WORDS | Alan Grau, Icon Labs Medical devices perform critical functions in surgery, hospital care and clinical settings. They even play an increasing role in home health care.

Millions of people rely on medical devices to stay alive and depend upon them to improve the quality of their lives.

Few people however, think about safety and security. These devices rely on specialised computers to control their operation. They often have a computer embedded within the system, that not only controls the operation of the medical device but also provides communication capability allowing remote reporting, diagnostics and control.

Remote communication enables continuous patient monitoring, remote diagnostics allows doctors to view patient information without requiring an office visit and provide significant convenience and cost savings. However, these same communication capabilities can expose the devices to a host of cyber-threats.

The cyber threat There have been a number of well-documented security vulnerabilities involving medical devices.

Perhaps the most startling of these was a report on June 13, 2013 from ICS-CERT (Industrial Control Systems Cyber Emergency Response Team) that listed over 300 devices that relied upon hard coded passwords. These can permit hackers to easily gain control of the devices and make it impossible to update the passwords to

block future attacks. According to its report, the vulnerability could be exploited to change critical settings and/or modify device firmware. The vulnerability affected a range of devices including: Surgical and anaesthesia devices, ventilators, drug infusion pumps, ventilators, external defibrillators, patient monitors, laboratory and analysis equipment. This issue was so severe that it prompted an alert by the FDA and Department of Homeland Security containing security guidance for medical device manufacturers.

Security challenges Medical devices are very different from standard PCs. They are fixed function devices designed to perform a specialised task and often run a specialised embedded operating system instead of Windows or Linux. Installing new software on the system in the field often requires a specialised upgrade process or is simply not supported.

These devices are optimised to minimise processing cycles and memory usage and do not have a lot of extra processing resources available.

PC security solutions won’t solve the security challenges of these devices.

Challenges for medical device security include: 1. Critical functionality — medical devices control life-enabling systems and manage data.

2. Replication — medical devices are mass produced. A successful attack on one device can be replicated across all devices.

3. Security assumptions — many medical device engineers haven’t considered security a critical priority.

4. Not easily patched — most medical devices are not easily upgraded. Once they are deployed, they will run the software that was installed at the factory.

5. Long life cycle — this can be up to 20 years. Building a device that will withstand the security requirements of the next two decades is a challenge.

6. Deployment — medical devices may be mobile or may be deployed in the home, environments lacking the protections found in a corporate environment.

There is no one one-size fits all security solution for medical devices. Engineers must take into consideration the cost of a security failure, the risk of attack, available attack vectors and the cost of implementing a security solution.

It is critical that security be built into the device itself so the devices is not dependent on the corporate firewall as its sole layer of security and security can be customised to the needs of the device. This requires security software designed for use in embedded devices. Security features must be considered early in the design process to ensure the device is protected from the advanced cyber-threats they will be facing.

SECURITY FEATURE

IMPLEMENTATION IN EMBEDDED DEVICES

Secure boot

Achieved using cryptographically signed code from the manufacturer along with hardware support to verify code is authenticated. This ensures that the firmware has not been tampered with.

Secure code updates

Secure code updates ensure that the code on the device can be updated for bug fixes, security patches, etc. Use of signed code (secure boot) ensures that malicious code cannot be introduced.

Data Security

Prevent unauthorised access to the device and its data by using encrypted data storage and/or encrypted communication.

Authentication

Communication should be authenticated using strong passwords (at a minimum) or an authentication protocol such as Kerberos.

Secure communication

Communication to/from the device needs to be secured using encryption (SSH, SSL, etc.).

Protection against cyber attacks

Embedded firewalls provide a critical layer of protection against hackers and common cyber-attacks.

Intrusion detection & security monitoring

Many medical devices can be attacked repeatedly without detection. A hacker could execute millions of invalid login attempts without the attack being reported.

Integration with a security management system allows security policies to be updated to mitigate against known Embedded security management threats.

Some board designs include device tamper detection capabilities, enabling detection when the seal on the device Device tampering detection enclosure is broken; indicate that someone attempting to tamper with the device.

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DIGITAL SPY APPY TALKING

BREAKTHROUGH

RAPID BLOOD TESTING DEVICE

fast-tracks to success

I

Rowan Grant, national outreach manager Medical Technologies Innovation and Knowledge Centre, University of Leeds

Flipboard: I’m absolutely in love with Flipboard for bringing all my favourite dynamic web-based content to one place. I was looking for something to subscribe to RSS feeds with since Google closed its reader, but Flipboard brings together all the news I am interested in into a lovely visually interesting personalised newspaper. So I’m subscribing to our funders’ news and news from sources in the medical device industry, plus healthy lifestyle blogs and interior decoration all in one place – presented like a magazine.

Instagram and Pic Stitch: I mainly use these for personal use, Instagram is a great app for capturing creative photos using filters to give them a vintage look. However, I have used it professionally. Our centre was recently featured in a magazine so I took some shots using Instagram of the centre pages and the magazine cover, then used Pic Stitch to create a collage of the photos. When I shared it on Linked In it got over 450 views!

Evernote, Skitch, Penultimate and Peek: This is a group of apps that work together to help you to remove the pens and paper form your life – perfect for the iPad. Evernote allows you to create notebooks, it even synchronises with your diary so it tags each note with the meeting you were in at the time. You can record audio within it, and use Skitch with it to annotate photos and PDFs. Penultimate is similar to Evernote except for handwritten use – good if you want to jot down a diagram. Peek is great for studying for an exam – you can import notebooks from Evernote and make study materials into flashcards, using the iPad smartcover to ‘Peek’ at the question and peek at the answer.

Google maps: This is great used as a free SatNav if you buy a holder for the car, or even for walking around a foreign city as it still works with roaming switched off (somehow!). It’s been a lifesaver helping me to find my way to places and for calculating how long it will take me to get somewhere.

Remember the milk: This is a nice, easy to use, to-do list maker. It’s easier than using the ‘notes’ app as you can just check off items as they are completed rather than deleting whole rows.

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de Group’s innovative blood testing device has won the “Best in Show Award” at the 2014 Medical Design Excellence Awards, MD&M East. This device, the AtomoRapid HIV, designed with Atomo Diagnostics, is said to be the first rapid HIV blood test, offering a simple reliable solution for diagnosing HIV in the field and will be marketed for other medical conditions and infectious diseases in the near future, such as malaria and HIV.

“With the increasing demand in the healthcare industry for devices that are lower cost, faster, more convenient, and most importantly, accurate, AtomoRapid HIV is truly a groundbreaking device,” said Richard Sokolov, product development director, Ide.

SECTOR SPY

www.applieddata.org What to wear -

wearable injectors poised for growth According to Applied Data Research wearable injectors are positioned to profit from an expected surge in infusion procedures.

As drug discovery, development and commercialisation continue to produce therapeutic biologicals, device designers are being challenged to be more creative. This has produced a new class of subcutaneous infusion devices designed to be worn by the patient. While allowing patients to selfadminister high volume injectables, these devices are also expected to pose a cost-saving alternative to out-patient infusion centers.

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 subcutaneous delivery so are currently delivered via infusion.

Wearable injectors free patients from long hours of traditional drug infusion while providing patients with access to prefilled device drug products. Most of the devices that comprise the current generation of wearable injectors utilise a piston or piston-type method to deliver the drug. About half of the current generation of wearable injectors is electronic disposable models, another 30% are semi-disposable and the remainder are mechanical disposable units.

Initial growth in wearable injectors will come primarily from high volume drugs that can be administered subcutaneously. Wearable devices are well suited to meeting this need.

TWITTER WATCH

MPN’s top Twitter picks @AMDR AMDR promotes the legal, regulatory & related interests of the global third-party medical device reprocessing industry.

We liked . . .

Hospitals implement new recycling program to “green the operating room” @MaetricsAgility Maetrics specialises in compliance — prevention, performance improvement and resolution — for life sciences companies.

We liked . . .

A wearable exoskeleton for patients with lowerbody paralysis has been approved by the FDA @rmontazami Assistant professor @ Iowa State Uni whose research is focused on smart materials and structures, with emphasis on polymeric nanostructures.

We liked . . .

Just finished an interview with #foxnews on my transient electronic devices @PlasticITltd Providing a 100% accurate measuring and validation technology for the analysis of internal and external geometries in micro plastic parts.

We liked . . .

3D scanning takes a look inside complex parts @InterplasUK Interplas 2014 — The British Plastics Show. 30 Sept - 2 Oct 2014. Hall 4, National Exhibition Centre, Birmingham, UK We liked . . .

Iain Wright MP shadow minister for industry within the shadow business, innovation & skills team confirmed as keynote speaker

NEWS

3D printing quest – winner named GE has named LayerWise winner of its worldwide open innovation challenge, the 3D Printing Production Quest. LayerWise’s winning submission showed its capability to produce complex medical imaging device parts with high precision. GE says that high-end metal 3D printing capabilities mastered by LayerWise will help drive greater product performance, higher quality and more significant cost savings for healthcare customers. Being awarded by the largest industrial group in the world, LayerWise is likely to become a technology partner to GE.

ONE MORE THING Isn’t it funny that the FDA’s recent social media guidance for medical device and drug companies has a title containing so many characters, it’s too big for Twitter?

The guidance — Guidance for Industry: Internet/Social Media Platforms with Character Space Limitations—Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices — advises that says if you need more room to reveal facts than the medium allows, don’t use the platform.

It tells medical device companies that every communication you make has to stand on its own and that information should be accurate and non-misleading and reveal material facts within each individual character-space-limited communication’.

It would be interesting to know if your company is making use of social media. If so, is the guidance helpful and, has it inspired you into tweeting?

DIGITAL SPY

My top tweets Courtney Hanks, marketing communications specialist, Instron @instron @instron · Jun 4 Learn about the recent changes to ISO 5271, 2; ASTM D638; and ISO 178 http://ht.ly/xDm5s #materialstesting A presentation tells readers about the impacts of the recent changes to international testing standards. @instron · Jun 6 Congratulations to our award recipients from The Symposium on Structural Durability in Darmstadt for their research! http://ht.ly/xIPVI Scientists are highlighted at the Symposium on Structural Durability in Darmstadt for research on fatigue testing. @instron · Jun 10 Sorting 15,000 lbs. of food donations? No problem. The @Instron team were all smiles when volunteering. #community http://ow.ly/i/5RsOw Instron is proud of employees giving back to the local community. @instron · Jun 13 Instron live webinars provide the opportunity to hear updates from experts on industry news and testing... http://fb.me/2bOn51KYo Here is a link to live webinars explaining testing standards and the DIC technique. @instron · Jun 23 How to reduce downtime between tests and promote consistency when analyzing plastic materials: http://ht.ly/ylZah #materialstesting Here readers can learn ideas on how to decrease time in materials testing.

MOVING

story...

TALKING POINT Sharon Martin is Teknor Apex’s new corporate marketing communications manager She will take responsibility advertising, public relations, trade show coordination, marketing collateral, and digital marketing for all Teknor Apex business units worldwide, including vinyl, thermoplastic elastomers, nylon, custom compounding, colour concentrate and the chemicals division What attracted you to your new role?

What attracted me to Teknor Apex was the company’s unique story. With 90 years in the making, the company has successfully expanded its product line and global footprint while retaining an impressive list of loyal customers and employees. I was also very interested in the collaborative nature my role would have with all the business units worldwide.

What areas do you plan to focus on?

I will be working on enhancing our brand recognition both here in the United States and globally, as well as focusing on the synergy of our product lines. My role will oversee all our public relations with an emphasis on increasing our digital marketing efforts.

What’s the company’s USP? Teknor Apex’s unique selling proposition is the level of customisation and service provided to our customers. We are one of the world’s leading custom compounders of plastics because of our long-lasting relationships with our employees, suppliers and customers. Our focus on compounding creativity with technology distinguishes our products but it’s the people involved that truly set us apart.

Where do you see the business in five years time?

I expect our brand recognition to rise as we increase our marketing efforts. I believe the business will continue to grow with our existing customers and our new client base will rise as we develop new and exciting products. www.teknorapex.com

JULY - AUGUST 2014 / MPN /9

NEWS ANALYSIS

{Singled} out Dan Vukelich, the Association of Medical Device Reprocessors, examines issues surrounding ‘single use’ devices, the opportunities available for the reprocessing of these devices in the EU and how it can learn from the US experience

W

orldwide, hospitals are reusing medical devices originally labeled by manufacturer as ‘single-use’.

Even in Europe, where countries have policies that explicitly discourage such reuse, it still takes place. This excludes Germany, where reuse is subject to requirements and oversight. In most other European Union Member States, the reuse of ‘single-use’ devices (SUDs) takes place in the shadows, without any validated reuse instructions or oversight, and often in contravention of governmental policy. Hospitals do so out of economic necessity and sometimes because many hospital personnel are suspicious that the ‘single-use’ designation used on manufacturer labeling, is more of a marketing ploy to sell devices than it is the result of regulatory requirements.

The European Union (EU) now has the opportunity to address the issue at the EU level. As part of a larger EU-wide Medical Device Regulation proposal, both the European Commission and the European Parliament have proposed to regulate the reprocessing of SUDs.

manufacturer (OEM) parent companies, must meet the US FDA’s requirements for medical device manufacturers, including premarket clearance and review. The result of US FDA regulation has been dramatic growth in the SUD reprocessing market, which has allowed US hospitals to save hundreds of millions of dollars and prevent millions of tons of medical waste from going to landfills or incinerators.

What exactly does manufacturer treatment of SUD reprocessing mean? Since the original manufacturer has labeled the original device for ‘single-use’, the reprocessor has to stand in the shoes of that OEM for any subsequent sale of that device. The reprocessor must provide to the notified bodies what the OEM did not – data showing that the device meets manufacturer standards for the pre-set number of reprocessing cycles that have been scientifically validated by the reprocessor. It means that the reprocessor becomes subject to the same pre- and post-market requirements of notified bodies and competent authorities, like other manufacturer, including:

Supporting SUD reprocessing The Association of Medical Device Reprocessors (AMDR), the trade association for the interests of the third-party medical device reprocessing industry, supports the goal of regulating SUD reprocessing. Specifically, AMDR supports the basic framework of the European Commission’s proposal, which would require any entity that reuses an SUD to assume full responsibility as the medical device manufacturer, including demonstrated compliance with the essential requirements to a Notified Body and CE marking.

Treating SUD reprocessing as manufacturing is not a novel concept. American third-party reprocessors include companies such as Medline ReNewal (part of Medline Industries), Stryker Sustainability Solutions (part of Stryker Corp) and Sterilmed (part of the Johnson & Johnson family of companies).

Each of these reprocessing companies, now also part of much larger original equipment

Labeling — reprocessors will label the devices, indicating it is reprocessed with the reprocessor’s name as the responsible manufacturer; Device identification (including UDI), tracking, and registration requirements; General manufacturer safety and performance requirements; Vigilance and market surveillance requirements, including adverse event reporting as the responsible manufacturer (not the OEM); Quality system requirements including conformity assessment requirements; and Clinical evaluation requirements.

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Put to the test Beyond meeting these requirements, AMDR’s members go a step further by testing or inspecting 100% of the devices they reprocess.

Most manufacturers conduct batch or sample tests. AMDR member reprocessors provide individual scrutiny to each reprocessed SUD.

Medline ReNewal, Stryker Sustainability and Vanguard, Europe’s largest commercial reprocessor, make up the membership of AMDR. In the US AMDR member-companies meet FDA’s manufacturer requirements that they have demonstrated their reprocessed scalpels, saw blades, pulse oximeter sensors, and cardiac catheters, for instance, are as safe and as effective as a new device. AMDR’s members are fully to the manufacturer standard for SUD reprocessing in Europe.

Not suitable for all devices AMDR’s members believe that not all SUDs can and should be reprocessed. AMDR believes that, based on current technology, only a very small subset of SUDs can be reprocessed. Even reprocessing that small portion of SUDs can have a positive impact on hospitals and healthcare systems without compromising patient safety. The savings potential by reprocessing just 2-3% of SUDs could be billions of Euros – not to mention the amount of medical waste diverted from landfills.

Regulatory history of reprocessing, using the US FDA regulation as one example, demonstrates that once SUD reprocessing is held to manufacturing standards, inappropriate reuse of SUDs stops because entities that cannot meet the requirements are forced to halt the practice or outsource to entities that meet the standards.

With some minor but important modifications, the European Commission’s proposed regulatory approach can serve as the basis for the EU’s reprocessing rules. Done correctly, a single framework will ensure patients across the EU can expect the same level of safety from the medical device they receive, new or reprocessed. It is fair to hospitals in that it provides a legal, overt pathway for them to use lower-cost, environmentally friendly reprocessed SUDs. Finally, the approach is fair to both reprocessors and OEMs in that it levels the regulatory playing field.

NEWS PROFILE

TESTIMONIALS OF PREVIOUS ATTENDEES ‘Well organized conference. We have had several conversations underway with new partners or potential partners which resulted from our being part of your event’ S Lindsey, Meredian BioPlastics

‘Very nice conference with networking opportunities; made a good number of business contacts that will lead to future business for our product!’

James Gaspard, Biochar Now ‘Very trenchant topics, well organised, and good networking; an excellent conference!’

Dr. Bob Hamilton, Weyerhaeuser

MPN announces polymers

& plastics in medical devices Medical Plastics News and InnoPlast Solutions are pleased to announce the Polymers & Plastics in Medical Devices conference. The event will be held in Orlando, Florida, USA, April 21-23, 2015.

Lu Rahman, Medical Plastics News group editor, said: “We are delighted to be working with Innoplast Solutions on this event. The plastics and polymer market is significant and we are very much looking forward to discovering the latest trends and developments in the medical plastics sector through this event. The medical polymer market is set to rise by half over the next five years to reach around $3.5bn (2.1bn).

This is an increase of around 52% from 2013 to 2018. With this in mind, the event is perfectly timed to showcase the innovation and technological advances currently taking place within this sector.”

The aim of this conference is to bring participants up to speed with the newest trends and technical advances in the field of medical devices as it relates to polymeric materials. The target audience is medical device producers, moulders of sub-assemblies, plastic & additive suppliers, equipment & prototype designers, regulatory professionals, sales, marketing, and business development leaders throughout the entire supply chain of the healthcare industry.

The conference has been structured to provide ample opportunity for networking to encourage the sharing of new ideas and concepts throughout the value chain. www.mediplastconference.com

MPN

A

‘A sweeping and comprehensive conference which provided an unusual blend of economic, technical and logistic analysis of the bio-plastics industry. I was impressed by the advancements presented here from breakthroughs just within the past couple of years’ Noah Grade, Krauss Maffei ‘Good technical program, perfect for experts and non-experts alike. A great overview of where the bio-plastics industry is going’ Joe O’Connell, The Hershey Company

‘Thank you very much for allowing FKuR to participate in your conference. The conference was one of the best we have attended this year in regard to the content, structure and participation. You created a conference that should be considered a must attend for those within the bio-plastics industry and we look forward to attending future conferences’ Kelly Lehrmann, FKuR Plastics Corp ‘I completely enjoyed coming to this conference. The selection of speakers and topics were excellent. If I come back to work with one or two new ideas, I consider the trip worthwhile. I was completely blown away with new ideas and networking opportunities’ Dr John Trent, SC Johnson

‘Very nice conference with high profile companies and speakers. Great update on bio-plastics. Good job! Bravo!’

Prajitna Sukandi, PT Sentosa JULY - AUGUST 2014 / MPN /11

MPN Medical Plastics News (MPN) and InnoPlast Solutions are Pleased to Announce a Conference on Emerging Trends in…..

Polymers & Plastics in Medical Devices The theme for this year’s 2-day conference on “Polymers & Plastics in Medical Devices” is to bring the participants up to speed on the newest trends and technical advances in the field of Medical Devices as it relates to Polymeric Materials. The target audience is Medical Device producers, Molders of Sub-Assemblies, Plastic & Additive suppliers, Equipment & Prototype Designers,

Regulatory professionals, Sales, Marketing, and Business Development leaders throughout the entire supply chain of the Health-Care industry. The conference has been structured to provide ample opportunity for networking to encourage the sharing of new ideas and concepts throughout the value chain.

April 21-23, 2015 DoubleTree - Hilton, Orlando, FL 32804, USA Call for presentations We are soliciting presentation(s) that represent a NEW development in any of the following areas: IMPLANTS: CardioVascular, Orthopedic & Vision Care DURABLE Applications: Housing & Components for Medical Devices DISPOSABLE Applications: Catheters, Tubings, Storage & Diagnostics NEW DEVELOPMENTS: Coatings, Additives & Processing for Higher Performance

What is Required ?

In order to make it easier for the speakers, we are asking only for the Presentation Title and the Speaker’s contact information by AUGUST 15, 2014; nothing else is required until April 1, 2015 when the PowerPoint slides will be due.

Presentation TITLES can be emailed to info@InnoplastSolutions.com; for further details, call Innoplast Solutions at (973) 446-9531 in USA or visit www.MediplastConference.com

NEWS ANALYSIS

The Future of Health Care: Tissue Engineered Medical Devices WORDS | Anna Wynn, business development manager, Instron® TERM Tissue Engineering and Regenerative Medicine (TERM) is dedicated to creating new tissue-engineered medical devices that replace and/or enhance tissue function that has been impaired by disease, injury, or age. Tissue-engineered medical devices are a combination of cells, scaffolds (materials on which to grow the cells) grown to produce 3D tissues that are similar to native tissue.

Today’s health care system is focused on treating the conditions of disease and moderating the symptoms; TERM is focused on repairing the damaged tissue. This paradigm shift has the potential to drastically improve health care, as well as provide huge economic savings. As an example, the annual direct costs of organ replacements are currently $350 billion worldwide or about 8% of global health care spending. These costs include clinical therapies to keep patients alive, implanted devices, and organ transplants. Despite the astronomical cost, only a fraction of patients waiting for organs are receiving them. According to the Organ Procurement & Transplantation Network (6/19/14), there are 125,695 organs on the waiting list while only 3,407 have been recovered this year for transplantation with a 50% mean success rate.

In the future, tissue-engineered therapies could cure some of these diseases and stop patients from relying on organ donors.

Patients could receive the healthy tissue they need – tissues made of their own cells to cure their conditions and end treatment.

These therapies eliminate immune responses.

Without a change, health care costs will continue to rise. In fact, research indicates that costs will double by the year 2040, reaching heights that the world cannot sustain.

Example: Cardiovascular Disease The World Health Organization recognizes cardiovascular disease (CVD) as today’s largest single contributor to global mortality and they expect that it will continue to dominate mortality trends in the future. Data indicates that there will be about 20 million CVD deaths in 2015, accounting for 30% of all deaths worldwide.

Contributing to these numbers are coronary disease and congenital heart defects. Both of these could be treated with tissue-engineered solutions: coronary artery bypass grafts and tissue-engineered heart valves. Tissue-engineered solutions are especially relevant to paediatric patients, providing a healthy replacement that grows with the child. Congenital heart defects are structural problems with the heart present at birth. They result when a mishap occurs during heart development soon after conception and often before the mother is aware that she is pregnant. Defects range in severity from simple problems, such as “holes” between chambers of the heart, to very severe malformations, such as complete absence of one or more chambers or valves. Out of 1,000 births, nine babies will have some form of congenital heart disorder, most of which are mild.

The mechanical devices currently used in these young patients require repetitive surgery to match the size of the device to the fast growing patient. However, if a young child receives a tissueengineered heart valve, it is a living tissue that grows with the child, eliminating the need for future surgeries. Furthermore, the device is generated using the patient’s own cells removing the risk of rejection or complicated immune responses.

New tools are being used by researchers around the world to develop tissue-engineered devices. One of these tools is a bioreactor, which is designed to provide a controlled environment for growing the tissue outside of the body. It can use mechanical means to influence biological processes. In tissue engineering, bioreactors can be used to aid in the in vitro development of new tissue by providing biochemical and physical regulatory signals to cells and encouraging them to undergo differentiation and/or to produce extracellular matrix prior to in vivo implantation. In the case of heart valves, the mechanical stimulation (pressure, flow) mimics a heartbeat to condition the valve and promote cell proliferation and differentiation. The combined mechanical, biological, and chemical cues provide instructions to the cells to tell them what to be; this ensures that the tissue-engineered heart valve will behave the same as a native valve.

Bioreactors are also being used in pharmaceutical research to treat cardiovascular disease. The ability of these tools to mimic the native physiology allows researchers to study the effects of new pharmaceuticals in a controlled environment on the bench top. Previously, these conditions could only be achieved in an animal model or clinical trial.

Today, researchers hope that tissue engineering research can combat the future of increasing CVD deaths worldwide.

JULY - AUGUST 2014 / MPN /13

READY-TO-FILL

POINT OF VIEW F

or many years glass has been treated as the ‘gold standard’ in packaging of most of liquid medications and syringes. Its qualities are undeniable: it reacts with the ALEKSANDRA JONES rarely substances it holds and it OUTLINES THE doesn’t allow for fluids, IMPORTANCE OF PLASTICS vapours and oxygen to through. It is also IN THE PRODUCTION OF pass transparent, which allows a READY-TO-FILL SYRINGES quick inspection of the contents, and is easy to mould into different shapes, dependent on the purpose of the particular item.

Nevertheless, many of us are also familiar with plastic syringes, which have been around for some time. They have mostly been produced from polyethylene or polypropylene, which means they can be made a lot cheaper than their glass equivalents.

However, they are not designed to hold liquid medication for longer and can only be filled right before the injection takes place. This is in contrast to glass, which can be used to store liquids for several years.

Alternative to glass Glass, with its many advantages, is however prone to breakage, which is one of the reasons why finding a suitable alternative has been vital for both the pharmaceutical and the medical industries. Syringe producers started using a plastic called cyclic olefin copolymer (COC)/cyclic olefin copolymer (COP) several years ago and it turned out to be a much more viable solution than using cheaper polyethylene and polypropylene. COC/COP is transparent, which means that the contents can be instantly inspected for clouding or other changes. It doesn’t break as easily as glass, making it a lot more durable; this stops unnecessary wastage of expensive medications. The most important property, however, is the fact that COC/COP acts as a relatively good barrier against water vapour and oxygen and provides adequate protection for the pharmaceutical it holds.

Many drugs available on the market are expensive to produce and any wastage incurs high costs for the company; this means not only breakages, but also exposing the medication to the influence of external conditions. COC/COP syringes, thanks to their high quality, are often used as packaging for injectable biotechnologically derived drugs, which are both expensive and highly susceptible to external conditions. Hyaluronic acid, used in orthopaedics, cosmetic surgery and other treatments, as well as opthalmics, is an example of product that requires high-quality packaging, and is filled into COC/COP syringes.

No interim cleaning The production of COC/COP syringes requires cleanroom conditions, and is usually done without human involvement, in a fully automated process. That means that syringes produced in this way don’t require interim cleaning stages, as it is in the case of glass syringe production, which involves washing the products with pharmaceutical water and eliminating glass dust. COC/COP syringes are produced using high-precision injection moulding, 14/ MPN / JULY - AUGUST 2014

<< Role play: The environment in which medication is administered is important in choosing the right syringe for the job. >> with cyclic olefin polymer granules being poured into the injection moulding machine. This allows for tight tolerances and accurate geometries of the ready product, which means that less medication residue remains in the syringe after the injection — it is an important argument in the case of expensive pharmaceuticals, where any quantity of wasted product incurs large costs.

Of course syringes are used for a variety of drugs and there isn’t one type or material that will suit all applications perfectly. Cost is very often the deciding factor in decision-making processes of healthcare providers, provided it doesn’t have implications on the safety of the patients. Increasingly the option of ready-to-fill syringes wins, as it becomes more common for patients to dispense their medications themselves or have administered at home by a health professional or another qualified person. This saves both the personnel time and costs, both of which are limited in modern healthcare systems.

Taking all this into consideration, cooperation of syringe manufacturers and pharmaceutical companies is extremely important. Collaboration at the very early stages of drug development can save a lot of time and money spent on researching the best syringe solution for a particular medication.

Importance of choice It is vital that options exist for the pharmaceutical industry, especially where syringes are concerned. While COC/COP might be the best solution for innovative biotechnologically developed drugs, it is still more expensive than glass and does not possess exactly the same properties — glass is more gas/vapour permeable and inert and it will continue to be a viable option for many pharmaceutical manufacturers. In time, however, COC/COP syringes will certainly continue to develop and will be used increasingly for expensive applications requiring less wastage. In the case of some medications there are also legal requirements that need to be followed. The environment in which medication is administered is also an important factor in choosing the right syringe for the job: cheaper syringes made of polyethylene or polypropylene can be used in hospitals, medical centres or clinics, but for self-medication ready-to-fill syringes might be the best option.

This article used materials provided by Gerresheimer (www.gerresheimer.com) and Schott (www.schott.com).

COVER STORY

Dish of the day

P

etri dishes are used to cultivate microorganisms or cells under laboratory conditions. Until a few years ago they were made of glass. Today’s petri dishes, made with polystyrene (PS), have to meet the same requirements: They must be PLASTIC ARTICLES FOR THE dimensionally stable, and MEDICAL INDUSTRY PLACE transparent absolutely flat to THE HIGHEST DEMANDS ON ensure reliable TECHNOLOGICAL results of analyses. large PERFECTION. WHEN DEALING Increasingly, quantities are WITH INEXPENSIVE needed as more CONSUMABLES, EFFICIENT people worldwide access to PRODUCTION ALSO BECOMES have medical care.

IMPORTANT. NETSTAL OFFERS COMPLETE SYSTEMS FOR THE PRODUCTION OF PETRI DISHES AND MEDICAL PRODUCTS

While the medical market grows, manufacturers of petri dishes are facing increasing cost pressure from health insurers, resulting in shrinking margins. Their attention focuses more and more on optimising production with short cycle times and high availability as well as resource and material-saving production systems. Netstal’s medical technology division has specialised in such systems.

For example, anybody who wants to produce 50 million petri dishes per year can turn to the Swiss machine manufacturer with that request. Netstal will configure a complete production cell, including injection moulding as well as a removal, assembly and packaging system. For 50 million parts, for example, a fully electric Elion 3200 machine with an 8+8 cavity mould would be suitable. All components are coordinated perfectly in such a system. It delivers a result that is better in all aspects than a combination of various components by the user.

In medical technology operation in conditions that are as clean as possible is vital. Multiple options are available for cleanroom production (up to class ISO 5). The Med-Kit contains covers for hoses and niches as well as especially smooth surfaces to facilitate cleaning. For solutions outside of the cleanroom, laminar flow units are used above the machine and automation. With a continuous, low-turbulence stream of air, they reduce the amount of particles clinging to the products.

The individual components needed for the production cell are provided by permanent longstanding partners. Once the petri dishes have been produced in a cycle of about four seconds, they are removed through a free fall with a 2+2x-mould or from the side with the help of a removal module. In the subsequent assembly module, the lids are set onto the bottoms. They can then be stacked or taken to quality control. According to the customer’s wishes, the stacks can, for example, be packaged in an endless tubular bag and then in cardboard boxes. They are now ready to be used by doctors, in hospitals or laboratories.

At the upcoming Fakuma 2014 in Friedrichshafen, Netstal will present the performance of its systems by using the example of an 8+8x complete system with a cycle time of less than 3.7 seconds. Any business that wants to begin operation of a similar production system should consider Netstal. Based on the User Requirement Specifications (URS), a customer receives a comprehensive offer. Netstal, as independent contractor, offers a range of options and equipment packages, with the aim of designing the perfect production cell with the customer.

<< Dishing up: Today’s petri dishes, made with polystyrene (PS), have to be dimensionally stable, transparent and absolutely flat. >>

<< She’s electric: For 50 million parts, Netstal says a fully electric Elion 3200 machine with an 8+8 cavity mould would be suitable. >>

JULY - AUGUST 2014 / MPN /15

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SPEECH THERAPY

<< Write stuff: According to Ashley Goldie, a deluge of compliance change will affect labeling. >>

Time

FOR CHANGE

T

he life science sector is used to coping with regulation. But it’s about to face a deluge of compliance change. Here’s a brief summary of the ones that will be impact you, perhaps sooner than you think: Premarket Notification (510(k)) submissions for medical devices now need to take into account the full product lifecycle1. The Unique Device Identification (UDI) system THE AMOUNT OF REGULATION being introduced by the AND LEGISLATION COMING US Food and Drug 2 INTO THE LIFE SCIENCE SPACE Administration (FDA) comes into force in the US HAS NEVER BEEN HIGHER. this September, with ASHLEY GOLDIE OF ARTWORK Europe to follow within the MANAGEMENT FIRM KALLIK next 2-3 years – then China EXPLAINS WHY LABELLING and the rest of the world.

Companies targeting the WILL BE DIRECTLY IN THE US market will need to FIRING LINE – AND WHY A NEW submit device information APPROACH TO MANAGING THE to the new global UDI PROCESS WILL BE REQUIRED database (GUDID)3.

Vendors must include UDI information on all device labelling and packaging, provide a UDI in both plain-text and automatic identification and data capture (AIDC) formats4 and include UDI information on any device intended for multiple uses or requiring reprocessing after each use. Note that for the most invasive products, the deadline for compliance is bearing down hard, with compliance expected within nine months.

In Europe meanwhile, in September 2013, the European Commission announced two new measures to improve the safety of medical devices so as to “restore patient confidence in the medical devices sector” following events such as the PIP breast implants scandal5.

Some 10,000 types of products may be affected by all this – from sticking plasters to the latest generation of pacemakers.

That’s not all: it is now required that notified bodies randomly perform unannounced factory audits and check adequate samples from the production. Meanwhile, Brussels is also looking for clearer labelling, down to the individual product level: the goal, as in the US, is to increase device traceability along the supply chain. Plus the Commission has already told the market it will not be sufficient to demonstrate that all devices are correctly classified – technical documentation must be ‘complete’, is its somewhat opaque directive here.

Why data is vital The bottom line here is that you need to have a robust, transparent process in place to deal with these, and any other potential, compliance challenges.

That means investment. But there is also an opportunity here, if you use the new requirements to drive deeper changes to the way you manage your labelling activities.

However, putting in ‘point’ solutions that keep the regulators happy may tick a box. But it will not deliver additional benefits to the business beyond meeting the immediate crisis.

Instead, a truly effective system should not simply be about delivering compliance, but ensuring that an organisation can prove that compliance, and in a way that does not have a detrimental impact on other business processes.

And why tech is your friend here Technology has a huge contribution to make in helping to organise and automate the way data is collected and managed to deal with all these challenges.

For example, our pharma customers report that a content-centric approach to working with labelling, as opposed to a document-based one, can be a huge time-saver. That’s because their systems will only ever have one instance of, for example, a usage statement, which it will then automatically track across all iterations, so that you never duplicate or corrupt content. For Jette Byg at Danish-headquartered Coloplast that supplies specialist medical products, “Kallik has brought a completely different perspective to the way we manage our content management activities. Previously, every change meant starting from scratch and could take months to implement, requiring approvals of local translations from 30-40 countries. Because changes happen all the time in our dynamic market, this meant we were never in compliance – we were always behind.”

This integrated, holistic approach could be a huge boon as you deal with the new legislation coming your way – as well as the consolidation, globalisation and other changes that you need to be on top of in the next few months and years.

1

http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/ premarketsubmissions/premarketnotification510k/ucm070201.htm2 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm?utm_source=MembersOnly+Updates&utm_campaign=c7c1e8c870-Proposed_Rules_7_5_2012&utm_medium=email 3 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/GlobalUDIDatabaseGUDID/default.htm 4 http://www.aidc.org 5 http://ec.europa.eu/health/medical-devices/documents/revision/index_en.htm. The associated regulations are 920/2013 on the designation and the supervision of Notified Bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices, plus Commission Recommendation on the audits and assessments performed by Notified Bodies in the field of medical devices 2013/473/EU

JULY - AUGUST 2014 / MPN /17

SPEECH THERAPY

<< Talk Talk: communication is as important to a business as R&D, says Babak Daemi, Everlasting Marketing & PR >>

VOCAL Exercise

Babak Daemi, managing director, Everlasting Marketing & PR discusses the importance of marketing and PR

Q. Who are you and what do you do?

I am Eamon O’ Connell and I am a design engineer.

I help customers innovate in the field of patient care.

Q. How would you sum up your company?

ProTek Medical is a medical technology company; employees are encouraged to be innovative and creative.

To be innovative requires freedom, to be a world class manufacturing supplier to the medical device industry requires strict controls, finding the balance is key to ensuring innovative medical technologies are manufactured in a highly regulated system.

Q. Name a business achievement you are most proud of.

The products we design and manufacture are used by our customers globally to provide a better quality of patient care.

There is a great sense of pride when the devices that ProTek Medical design and manufacture are used to provide a better quality of care.

Connecting directly with the patient’s needs ensures that our design and manufacturing focus is the same as our customers and we take the same level of responsibility and pride when lifesaving therapies are employed.

Q. What excites you about this industry?

This industry had changed considerably in the past two decades.

Companies that focus on regulatory compliance through structured process development processes such as process validation embed themselves as strategic suppliers. When you add in the design capability the engagement with customers changes to more of a partnership approach.

The industry rewards suppliers that offer innovation as a capability, minimally invasive therapies challenge what can be designed and manufactured at a micro level with new materials and polymer blends emerging with unique properties.

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

There is definitely a confidence in the life science market and in particular the domestic Irish market — it is a matter of being well positioned with the necessary resource and capacity to react to the demand. Speed to market is an important factor for our customers and this can be best achieved from a fully integrated design and manufacturing process.

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

That is what makes working in ProTek Medical so rewarding, every day our design and engineering group innovate and I get the chance to contribute to the innovation process. I believe bio absorbable materials such as poly(DL-lactic acid) and poly(L-lactic acid) will play a major role in future minimal invasive therapies such as bio absorbable, drug eluting stents.

18/ MPN / JULY - AUGUST 2014

We need to talk Marketing & PR, or communications, is as important to a business as R&D. After all, what use is a 3-D printer if no-one knows about it?

We live in the age of information and sophisticated communications so communication should be a major part of your business plan, not an afterthought. And marketing strategy is strategy that makes your business plan work.

Tactically speaking there is little better than becoming an authority on a subject close to your business goals. Authority gives your company the edge. Authority secures editorial coverage and gives your company credibility. And when a company has authority on a subject it becomes a go-to source for editors and journalists.

Communication tactics like PR and marketing can give businesses authority and invincibility on a subject or in a sector.

Top tips for gaining authority Tip 1: Chose the best topic. This sounds obvious; however, it is the starting point that is usually wrong. Some companies try to be the market authority, or even global industry specialists. Be more refined, be more targeted and be more creative. Focus on your solution. For example, if you manufacture medical devices made from plastic, focus on the solution the device provides. And once you have chosen it, stick to it.

Tip 2: Chose the best communication tools for your desired target audience. The best ways are white papers, social media, blogging and if you are comfortable with it, public speaking.

Tip 3: Be patient. It takes years to naturally become an authority.

This process can be sped up using a well-connected and highly skilled PR agent of course, turning years into months. However, remember, to be thought of as an authority, you need to provide rich content that offers value to the reader, teaching them something they didn’t know or providing fresh insight into a subject.

Tip 4: Be Responsive. Staying focused on your key subject and providing media comments will give you and your business an authoritative position. ‘A tip within a tip’ - use a news aggregator and focus on the chosen subject. Ensure to provide comment to key news outlets as quickly as you can. A good PR agency will do this for you and will be following news relevant to the chosen subject.

The WRITE stuff: Dave Taylor, VP of global products, Prisym ID, looks at the evolution of medical device labeling The introduction of Unique Device Identification (UDI) regulations signals a major shift in the labeling of medical devices. The development of labeling solutions for the sector has been a steady evolutionary process – but not everybody has taken the journey. While some companies have recognised the benefits of introducing more scalable solutions – driven by data, not label outputs – others remain on the lower rungs of the evolutionary ladder. But the introduction of a common UDI mandate is a once-ina-generation game-changer that gives device organizations no choice but to change.

So is your current labeling infrastructure aligned with the new UDI regulations? Moreover, is it aligned with your business objectives? Fully integrated label lifecycle management solutions not only provide a mechanism to ensure regulatory compliance, they also provide an engine for growth.

The process of evolution Device labeling systems have been through three distinct stages of evolution. The ‘origin of species’ was largely a localised solution managed at a site level. Silo systems focused on the provision of outputs – labels – and were generally run from basic software held on individuals’ PCs. They offered little standardization and no centralized control.

Roughly ten years ago, systems evolved to provide greater regional or divisional control; operational clusters began to centralise and standardise the label design, review and approval processes. Though methodology still focused largely on the label, there was an increased emphasis on data.

The latest development is the emergence of integrated label lifecycle management (LLM) solutions that provide accessibility right across global organisations. These systems recognize that effective content management can enable standardisation and ensure that processes are controlled centrally, distributed locally and cater for local language and country-specific requirements.

All-round view LLM is data-led, with labels considered merely the final output.

The best solutions give companies a 360° view of all their data assets, enabling an integrated organisation-wide approach to production processes. They provide a centralised platform that can be leveraged across all sites, regions and divisions – and are interoperable with existing enterprise systems. These scalable web-based tools deliver complete label integrity – from data management to design and approval, through to label production and inspection – to meet strict regulatory requirements.

Labeling defects remain responsible for a high percentage of voluntary device recalls. The implications are significant; efficiency, productivity and ROI take a hit, whilst the potential damage to brand reputation is equally severe. Moreover, the financial penalties for non-compliance are unforgiving. With regulatory scrutiny intensified by the introduction of the UDI directive, the catalyst for change is compelling.

Assuring UDI compliance presents great challenges. Companies’ typical approach to the design, creation, approval, printing and inspection of labels is variable and fragmented; processes are often resource-intensive, inefficient and prone to human error.

With data commonly maintained off-line and rarely integrated with other business systems, companies are increasingly vulnerable to mislabeling and voluntary recall. A broader view is required. Labeling solutions cannot sit in isolation, they must be built into a 360° view of all variable data components.

Finding solutions But meeting the challenges of UDI does not need to be daunting.

LLM solutions can facilitate a more strategic approach to the management of global data, and help companies capture, store and disseminate data quickly, safely and accurately. The benefits are significant. LLM platforms can reduce unnecessary manual checks, improve quality control by optimising automated validation systems, and accelerate products to market.

Centralised data creates a platform for a ‘single version of the truth’ that can be used to generate labels ‘just in time’ – ensuring that the right information goes on the right product at the right time, every time. And holistic systems also allow for post-print verification to ensure no errors have crept into the process; vision verification solutions carry out automated audits, assuring approved imagery and data has been printed correctly on every label, as well as delivering lifecycle traceability. Moreover, LLM provides data visibility for stakeholders right across multinational, multi-site organizations.

Inefficiency has long troubled medical device manufacturers, but the perceived trauma of change has dissuaded organisations from overhauling their systems. UDI removes the option of choice. Without standardised mechanisms, the cost of implementing UDI controls will undoubtedly be prohibitive.

The mantra is therefore simple - evolve or die. In a changing marketplace, companies must climb the evolutionary ladder and adopt integrated systems that empower multi-national workforces with data accessibility and visibility – and provide enterprise-wide operational efficiency and agility. It’s the theory of evolution, the survival of the fittest. To thrive, a Label Lifecycle Management solution may just be the natural selection.

JULY - AUGUST 2014 / MPN /19

DESIGN 4 LIFE

Julian Swan

TEAM spirit

S

ix months may seem like a tight timescale to many companies, but having a well established process focused on medical device quality is half the battle and can make the road to certification easier. Having refined such a process over 40 years, IDC found that the approach became a natural progression towards formal certification.

Even so, the pitfalls remain and there are certain routes that can make the process dramatically easier. It may seem obvious, but engaging a whole company approach is essential. Keeping the quality process simple makes After achieving ISO 13485 and change more palatable internally 9001 in under six months, product and much easier for everyone to get involved when they’re busy design consultancy IDC knows with day-to-day tasks.

how to take the pain out of what can be a complicated process.

Swap the red tape for simplicity, says IDC’s engineering director, Julian Swan, as he shares his experience of avoiding the pitfalls and striving for best practice

Getting commitment from everyone in the company is essential, from the top down. As an SME we were able to involve the directors through to administrators, so we could establish the best ways of doing things. After all, it is the staff who are using the quality system, so it makes sense that they have a say in the best way of doing things.

For IDC, the quality process was not just about being procedural but about how it could further benefit its design process for clients. By establishing open communication and short weekly quality certification meetings for the whole company, IDC was able to focus on improving their existing process by taking onboard feedback from staff. The team was motivated to contribute by reward and recognition, which also encouraged feedback from all.

Another essential parameter for success is to seek the guidance of an external consultant who specialises in supporting companies to gain ISO certification. It’s easy to think you can goalone on this, but the investment of a consultant is worthwhile in terms of time and to establish a process that follows best practice.

It’s the same reason our clients come to us. Even now that we have achieved certification we still retain our external consultant, MDM, to give us a regular health check to keep on top.

20/ MPN / JULY - AUGUST 2014

IDC’s biggest challenge came when rolling the quality system out across other businesses within the organisation. The company has a base in Shanghai, IDC China, and also a well-established model making and prototyping business, UK-based IDC Models.

Whilst the process was complicated by geographical distance, the benefits have outweighed any issues. IDC Models now holds a rareposition in the market as a UK prototyping company offering ISO 13485 for batch production, with the same being true of its China office providing product design and development services with such a stamp of regulatory approval which is still unusual in the country.

This is an achievement in itself, but when you consider that we were managing the quality process for Shanghai from IDC in the UK, it speaks volumes about the benefits of tight communication throughout the process.

For companies still wavering about whether to take the plunge for ISO accreditation, perhaps examining the benefits abroad as well as at home is prudent. IDC China has benefited greatly from quality certification. Interestingly, the structured approach that the quality process demands has become a real asset for China where its clients naturally lean towards contracts and frameworks within business.

With increasing levels of medical product development in China, the quality process has added rigorous standards which have proved vital for Chinese clients looking to develop products for global markets. Additionally, the fact that both IDC and IDC Models in the UK, as well as IDC in China, now offer a standardised quality process means that clients can invest with the same level of confidence at either location, whether they are British clients taking advantage of the Chinese design services or vice-versa.

By letting our team take ownership of the process, we are now in a position where we all take a more analytical approach and are constantly asking ‘is this the best way?’. We are tuned into regularly re-evaluating the way we work, and this can only be a good thing for our clients as we move forward in a process of continual review and improvement.

DELIVERING UNIQUE MATERIAL SCIENCE SOLUTIONS - over and over again...

We succeed where others fail because we attempt things others don’t.

Far more than a tubing supplier, Zeus is a material science company that can be counted on to deliver unique and precise polymer solutions to overcome any OEM’s challenge. Almost 50 years of dependable innovation enables our scientists and engineers to propel medical device companies past “can’t” and into “how.”

We are partners that help our clients develop next generation technologies that change the world. To discover more about Zeus contact us by phone or visit us online at www.zeusinc.com.

IDA Business Park | Lisnennan, Letterkenny | Co. Donegal, Ireland Tel: +353 (0)74 9109700 | Fax: +353 (0)74 9109702 | www.zeusinc.com twitter.com/zeustubing

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PREMIUM MASTERBATCHES FOR SUPERB PRODUCTS. Medical Technology | Injection Needles We also support your new product concepts. Please contact our „Medical“ unit directly: medical@gabriel-chemie.com www.gabriel-chemie.com

Medical plastics at Interplas 2014 Interplas 2014 takes place on 30 September – 2 October at the NEC, Birmingham. Known as the British plastics show, this flagship event promises a host of exhibits and seminars to provide visitors with the knowledge, networking opportunities and above all, tools to boost business Interplas is the UK’s largest plastics exhibition and the only UK event to cover all of the manufacturing processes, technologies and services within the plastics industry.

For over sixty years Interplas has served as the showcase for plastics technology innovation and is known as the place for the plastics sector to do business in the UK. Every three years Interplas showcases hundreds of exhibitors and the event features technologies including injection moulding, rotational moulding, extrusion, blow moulding, thermoforming, vacuum forming, film extrusion, recycling, materials and design.

MEDICAL SPEAKERS AT INTERPLAS 2014 Marc Bax, md, Panchromos — the challenges in representative prototyping plastics parts or why 3D printing is not always the holy grail Rob Freeman, senior engineer, DePuy Synthes — polymer instrument design Shaun Rick, AST Technology – designing medical devices Neil Adams, operations and delivery director, medical devices, BSI Group — proposed medical device regulation

Alongside the show floor Interplas offers seminar presentations from industry leaders, commentators and users who shine the spotlight on the technologies and signpost how they will develop in the future.

Interplas 2014 boasts over 400 exhibiting companies set to display to over 12,000 attendees producing a world-class international forum for the British plastics industry to do business.

This year, Iain Wright MP, shadow minister for industry within the business, innovation and skills team, will deliver a keynote address at Interplas 2014.

Wright’s areas of responsibility cover business sectors, including the low carbon economy, manufacturing, construction and the motor industry; competitiveness and economic growth; as well as trade policy.

Medical plastics at Interplas Medical Plastics News will be holding a dedicated medical session at this year’s Interplas show.

The use of plastics in the medical sector has never been more important. As the limitations of stainless steel instruments become increasingly apparent, the significant benefits of polymers have come to the fore.

Advancements in material technology continue to grow enabling the manufacturing of safe cost-effective medical plastics parts which ultimately improve a patient’s well-being.

The MPN session at Interplas consists of industry experts who will be presenting on a range of key topics covering product design, manufacture and compliance.

Lu Rahman, group editor, MPN said: “The plastics and polymer market is significant and it is exciting to be part of this flagship plastics event. The MPN team is proud to have secured an array of top-class industry experts to discuss plastics in the medical sector.

“The medical polymer market is set to rise by half over the next five years to reach around £2.1bn. This is an increase of around 52% from 2013 to 2018.

With this in mind, the event is perfectly timed to showcase the innovation and technological advances currently taking place within this sector.”

22/ MPN / JULY - AUGUST 2014

<< Speak easy: Marc Bax, Panchromos will be presenting at the Interplas 2014 medical session on why 3D printing is not always the holy grail >>

INTERPLAS “The British Plastics Federation has been a strong supporter of Interplas since its origins over 50 years ago”

Key industry sign-ups highlight Interplas and UK market strength Global injection moulding machinery manufacturers, Arburg and Engel are on board for what will be the UK’s largest plastics industry exhibition and the only one of its kind to encompass all manufacturing technologies, processes and services within this arena.

UK plastics powerhouse BPF to open Interplas 2014 The British Plastics Federation (BPF), the leading trade association for the UK plastics industry, will present the opening address at Interplas 2014 on 30 September.

This auspicious start to the ‘must see’, three-day expo sets the tone for Interplas, which is prospering in its revitalised format. Interplas organiser Rapid News Communications Group is proud that the BPF will be launching the triennial outing this year, as it signifies Interplas’ importance as an event within the plastics.

The opening keynote will be delivered by Philip Law, the new director general of the body, which has more than 400 members across the plastics industry supply chain, including polymer producers and suppliers, additive manufacturers, service providers, recyclers, end users, machinery manufacturers and plastics processors.

“The British Plastics Federation has been a strong supporter of Interplas since its origins over 50 years ago,” Law said. “We regard the fair as a key platform for projecting the UK plastics industry to its key customers not only in the UK but in the wider world. It provides a vital opportunity to network, to handle equipment and products, to talk plastics and generate ideas.

“In our seminar session, the BPF will be exploring the key strengths of our world-beating UK plastics industry — specialist materials, ancillary equipment, packaging, technical componentry to name but a few — and will address some of the top-line issues facing the UK industry today.”

Editor of BP&R Magazine, Interplas lead media partner, Leanne Taylor stated: “As a powerful voice for the UK plastics industry, I am delighted that the BPF is giving the opening address at Interplas 2014. The show will provide the perfect platform for the association to deliver a strong programme, which is set to address wide-reaching topics at the heart of the industry through a experienced and knowledgable line-up of presenters.”

The last time Arburg exhibited at Interplas was in 2005, while Engel last had a stand in its own right in 2002, having exhibited in partnership with other companies in 2011.

Rapid News Communication Group’s revival of the show three years ago has transformed the triennial event into a ‘must-attend’ plastics industry show, which is why it is now firmly in the calendars of these industry giants.

Colin Tirel, managing director, Arburg UK, said: “I am delighted that Arburg is returning to the Interplas show.

After some years, we felt it was the right time to be included in the exhibition. As a leading supplier of moulding technology it is important for us to demonstrate innovative and relevant technology to our market. The UK and Irish markets have been key markets for us for many years and so we believe we are supporting the market by being there.”

Graeme Herlihy, managing director, Engel UK, said: “The UK proved to be very strong for Engel in 2013. The market size for injection moulding machines last year was the biggest since 1999, with the value coming close to £80 million. This figure is the best in years and shows how well the UK has recovered. So well in fact, that it has become a key focus for Engel again. Exhibiting at Interplas provides us with a great platform to reach this market and therefore we are planning some interesting and exciting features to demonstrate on our stand at the show.”

Duncan Wood, COO, Rapid News Communications, said: “We are delighted by the progress we have made since taking the event over. An extremely encouraging 2011 – which saw Interplas back in growth across the key metrics of space sold, number of exhibitors and of course visitors – is set to be exceeded spectacularly by the 2014 edition.

The momentum and appetite for the show is palpable across the industry and we are welcoming back major companies every day who can see we are steering Interplas in the right direction for the industry and, accordingly, they wish to be part of the success.”

JULY - AUGUST 2014 / MPN /23

INTERPLAS

“We are delighted once again to have the support of the PMMDA”

Interplas 2014 - PMMDA flying the flag for British plastics show Interplas has partnered with supporting organisation PMMDA for Interplas 2014.

PMMDA’s involvement reaffirms why Interplas is the unmissable event of the year and why it is relevant to the entire industry.

Originally formed in 1996 from eight founder companies in polymer machinery manufacturing and distribution, PMMDA’s mission is to set the standards of UK manufacturers and distributors of foreign machinery.

The group has grown to more than 30 members in polymers, plastics and related technologies and continues to provide a mark of superior quality, with members fulfilling criteria proving their authority in the marketplace and working together to develop EU and ISO standards for the entire sector. It is this indicator of excellence that makes PMMDA’s endorsement of Interplas so significant.

Nigel Flowers, PMMDA chairman, commented: “PMMDA is the trade association for machinery manufacturers and distributors within the polymer industry in the UK. Member companies carry the stamp of approval for sales, service and spares, and are pleased to be supporting Interplas 2014. Our members are confident that over the last 50 years Interplas has fully established itself in the UK, offering plastics industry professionals the opportunity to view and compare the widest range of machinery in action, covering every aspect of plastics manufacturing equipment.”

Duncan Wood, COO and event director, Rapid News Communications, added: “We are delighted once again to have the support of the PMMDA and its members for Interplas this year. Its support for the event is indicative of the strength of a resurgent Interplas and reaffirms the event as the leading event for the UK plastics industry. We look forward to a fruitful partnership in the run up to September and beyond.” www.interplasuk.com Twitter: @interplasuk

We are Visit INTER attend ing us o PLA S n The NEC stand 2014 F6 30th Br Sep iming 0, Hall t- 2n h 4 d O am UK , ct 201 4

VISIT OUR CASE ASE STUDY STUD FILES FOR MEDICAL AL DE DEVICE TREATMENT ATMENTS

TEL: +44 (0)1925 830 771 EM iinf @ )l ttme771 TEL L:AAIL : L+44 +: 44 4fo@plasma (0)1925 5ttrea 83 830 30 7nt71 7.c1o.uk WEB : www WEB: www.plasma l smatrea tme t.cco EMAIL AIL: inffo o@plasma @pla sma m atrea tr.pplas ea tmtren tmen eeat.co ttme ceon.uk uko.uk uk WEB www.plasmatreatment.co WEB: o.uk

JULY - AUGUST 2014 / MPN /25

PRODUCT FOCUS

CLEAN Sweep I

n the medical sector, plasma processing is routinely used to clean and surface treat stainless steel syringe needles, angioplasty balloon catheters and plastic lenses. It is an effective, economical and environmentally safe method for critical surface preparation and oxygen plasma eliminates natural and technical oils and grease at the nano-scale and reduces contamination up to six- fold when compared with traditional wet cleaning methods.

Plasma surface activation is a technique used to alter the surface of a polymer by attaching polar or functional groups to it. Many polymers, in particular polyolefins such as polyethylene and polypropylene, are chemically inert and cannot bond easily to other materials, displaying poor adhesion with inks, paint and glues. The reason for this is the absence of polar and reactive functional groups in their structure. Plasma surface activation renders many polymers receptive to bonding agents and coatings. Parts remain active for a few minutes up to several months, depending on the particular material that has been plasma treated. Polypropylene for example can still be reprocessed several weeks after treatment.

mounted configurations and can accommodate single or dual nozzle atmospheric plasma sources. A 5-phase stepping motor drives the plasma head over 3 axes to deliver accurate and reproducible surface treatment of a wide range of materials. Standard options allow for up to 500 x 500mm of XY motion and 150mm of Z motion. The units are fully programmable and have the capacity to store up to 255 programs each with up to 30,000 data points.

Both the table-top and cart mounted versions incorporate safety light guards and are perfectly suited to routine production tasks where localised treatment of surfaces is required to increase surface energy prior to painting, printing and bonding.

Plasma processing can take place in batch equipment (vacuum plasma) or in-line (atmospheric plasma). In-line plasma processing is often coupled with a programmable robot for treatment of 3D objects or complex shapes.

Hennikerâ&#x20AC;&#x2122;s automated bench-top plasma robot devices are available in table-top or cart

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Plasma processing can take place in batch equipment or in-line

LAB ON A CHIP

Micro management << Pure and simple: Porex says its certified pure materials were found to have virtually no material additives >>

PRIME factors Porex takes a look at factors affecting molecular test results in polymeric consumables Technological advancements of analytical instrumentation platforms coupled with demand for higher sensitivity in lab-on-a-chip based applications for the molecular diagnostics marketplace have led to a critical requirement for significant improvement in the degree of cleanliness of plastic consumables. Other motivating factors, including a preference towards single use disposable products for many lab-on-achip platforms, are also accelerating research into analysis of plastic resins used to manufacture these devices.

Compelling negative effects on assays due to plastic consumables have been identified by researchers in a number of diverse applications including cell culture, immunoassays, and PCR-based protocols among others (1-4). These negative effects are further magnified when using high surface area plastic consumables such as depth filters, as well as by a general trend towards using smaller volumes of sample and reagents.

Leachables and extractables (L&E) can affect assays and patient safety by potentially causing toxicity, carcinogenicity, immunogenicity, oxidation, aggregation and decreased stability over the shelf life of the product.

Identifying and quantifying leachables and extractables that are found in commonly used laboratory plastics and the effects of the contaminants on various assays is an increasingly important part of workflow development. In light of recent technological advancements and market requirements, Porex has initiated a Certified Pure Porex Program to qualify porous polymeric materials via a stringent program of various analytical, clinical and life science testing procedures. Porex advanced porous polymers were tested by means of Pyrolysis Gas Chromatography Mass Spectroscopy (PYMS), Proton Induced X-ray Emission (PIXE) and Liquid Chromatography Mass Spectroscopy (LCMS) for heavy metal contamination, polymeric components and other organic compounds.

Additional testing for hemolysis and cytotoxicity was performed using ISO 10993-5 MRM and modified ASTM F 756-08 GLP compliant methodologies.

Porex certified pure materials were found to have virtually no material additives, contaminants or heavy metals that cause interferences in clinical and laboratory testing. These materials were verified to be non-cytotoxic and non-hemolytic via independent testing labs. Porex Certified Pure materials have 99.9% Bacterial Aerosol Filtration Efficiency (BFE) as tested

by ASTM F21012 methodology. To our knowledge, this is the first extensive qualification program for porous polymeric materials that fills a critical gap in the progression of developing standardized methodologies in the analysis of leachables and extractables in plastic consumables.

CG Tec Injection has been producing lab-on-a-chip systems out of injection moulding since 2006. Four years ago, the company launched the national research project ComProMi with partners. The aim was to explore the CG TEC INJECTION HAS possibility to obtain 7μm SEVERAL YEARS’ microstructures in a polymerbased cartridge measuring a EXPERTISE PRODUCING dozen of centimetres.

LAB-ON-A-CHIP. IT DISCUSSES ITS RESEARCH PROJECT WHICH FOCUSES ON MICRO DETAILS IN INJECTION MOULDING

Usually micro-details are obtained through hot embossing, a process which is slow and therefore expensive in serial production. ComProMi focused on the possibility to obtain micro details in injection moulding, and create an economical advantage. As a result CG Tec could make use of these capabilities to produce a lab-on-a-chip system for a radiopharmacy application.

Design for manufacture Precision injection moulding companies usually target dimensions with a tolerance of 20-30 μm. Achieving details below 10μm requires a different industrialisation scheme. First of all, the design for manufacture plays an important role, having to choose a feasible layout with the highest success chances. This engineering step is tedious and requires advanced discussions between the interdisciplinary teams: chemists, biologists, designers.

Toolmaking and injection process To achieve 7μm microstructures the tooling itself and the injection process combine the latest techniques available. The mould, which can withstand hundred of thousands of shots, may include elements obtained through LIGA and sintering processes. Unlike in hot embossing, the injection moulding process can replicate features with dimensions varying from a few millimeters to a couple of microns.

The injection process itself occurs on a conventional machine, with accurate and variable temperature monitoring. The optimized cycle creates conditions for appropriate cavity filling and ultimate part stability. Once ejected, the part is then handled automatically in clean-room conditions to avoid contamination.

Reduced costs Lab-on-a-chip systems combine features like chambers, channels, filter, pumps, valves, micro-filters, UV chambers, heating zones. They all achieve functions such as mixing, splitting, spacing, metering and thanks to advances in injection moulding, droplet generation can also be monitored on cartridges as radii are eliminated.

Injection moulding will probably boost microfluidic applications, which are expected to boom in the coming years. Lab-on-a-chip systems, with 7μm microstructures can be produced in 1-2 minutes out of injection, whereas hot-embossing may release two parts per hour. This high-throughput, combined with a lower material consumption, makes the consumables affordable.

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LAB ON A CHIP

The real deal As counterfeiting continues to grow, Nano4u explains the significance of covert injection moulded ‘watermark’ features for authentication of moulded medical parts

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ounterfeit products are on the increase and in the case of medical products the issue is not just one of loss of income or litigation problems, but also a risk to human life. How can a manufacturer prove that a product is its own genuine product or a fake? How can a user or distributor verify that a product is genuine?

A new way of treating hardened steel tooling, developed by Nano4u, allows for holograms and covert verification features to be directly injection moulded onto plastic parts. These can be visible holograms that change with viewing angle, or hidden diffractive features that reconstruct an optical image when a laser pointer is directed at them. Without knowledge of the presence and location of the hidden features, the user is unaware of them.

When a user knows where and how to look, a verification check can easily be carried out.

One advantage of this new technology is that the holographic structures can readily be incorporated into existing steel tooling by surface structuring an existing steel tool insert or an ejector pin surface. Because the structure is part of the hardened steel, it has high durability and has been proven to last for over a million injection moulding shots.

The process has already been used with polymers ranging from commodity plastics like polypropylene and HDPE in the packaging industry, to filled engineering polymers such as PPS in the electronics industry. Demonstrated at some recent medical exhibitions, is the microfluidic lab-on-a-chip component.

This is a micro-moulded part, designed as a two-shot moulding.

The picture shows only the first shot assembly (the second shot moulds an elastomeric surround around the first part). The

micro-mould for the part, made by Micro Systems (UK) has a number of small ejector pins, and one of these is structured with the diffractive security feature.

The pin with the authentication feature is positioned in the centre of the ‘O’ in the logo on the plastic part. The ejector pin has a tip diameter of 0.8mm, making it the smallest ejector pin so far structured using this technology and a truly “covert” authentication feature. Larger ejector pins and inserts up to 40mm diameter can also be structured in this way.

When a laser pointer is fired through the centre of the “O” on the plastic, an image is reconstructed, which in this case shows a 2D barcode (image below). Depending on the diffractive optics design, this feature could be a logo, or lettering, or some other shape. When examined closely under a microscope on the plastic in the ejector pin witness area, all that is visible is a seemingly random pattern of tiny squares and micron-scale lines.

These types of diffractive features also work on opaque plastics, where the reconstruction of the hidden image using the laser is done in reflection instead of transmission. The effect also works with red wavelength lasers, but because the human eye is about 20x more sensitive to green, a green laser is preferred.

Depending on the ambient lighting, the image is either clearer or weaker.

Application of this new technology allows producers of medical devices and pharmaceutical packaging to easily implement a solution that add security to the serialisation practices that are becoming standard in the industry. Unlike serialisation codes, these features cannot easily be copied or removed.

<< When a laser pointer is fired through the centre of the ‘O’ on the plastic, an image is reconstructed - here it shows a 2D barcode >> 28/ MPN / JULY - AUGUST 2014

<< One and only: Engel is Luc&Bel’s sole injection moulding machine supplier >>

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INJECTION MOULDING

Sweet victory In just one year, biomedical sector start-up, Luc&Bel, has made a name for itself.

A set of Engel victory machines has contributed to the company’s success which manufactures high-precision components for the medical industry in a cleanroom

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ike the company’s other three founders Massimo Magnani, Francesco Greco and Costantino Bianchi Maiocchi, managing director Luca Ferrari is not a new face in the industry, and the location chosen for the new production site in the northern Italian town of Carpi also promised success from the start. Since being introduced to biomedical technology in the 1960s, the area surrounding Mirandola in the Province of Modena has become an important region on the global scale for suppliers in the industry.

The circumstances at the beginning were anything but ideal for the new site, however. Just a few weeks after the building work had started, the region was hit by a powerful earthquake, the consequences of which are still being felt by numerous companies now.

Luc&Bel was not too badly affected, but the completion of the building was delayed by four months and extra money had to be invested to safeguard the building more effectively from future earthquakes. Production was finally able to start in January 2013.

Strong suppliers guarantee future security Luc&Bel is based on two main pillars: high-quality fittings, which the company sells under its own label, and contract orders that cover the development of products, their construction and their mass production. The 1,200m2 clean room housing 12 Engel victory injection moulding machines with clamping forces ranging from 80 to 300 tonnes is the firm’s standout feature.

“Our planning has been far-sighted from the start,” stresses Ferrari. “A cleanroom validated once would cost a great deal of time and money to expand, which is why it was important to us to offer a wide spectrum right from the beginning. Building a new greenfield factory represented a huge opportunity for us, and we put all our experience together to create the best possible manufacturing conditions. Combining these with the best technologies available has now put us in a position to focus on innovation and quality permanently.”

Engel is Luc&Bel’s sole injection moulding machine supplier. Ferrari says: “When choosing suppliers, we look for quality and efficiency, and most importantly, stability. Engel has strong roots in Europe and here in Italy as well, and is able to guarantee us continuity, even when it comes to the after-sales service.

Technology provides efficiency Another Engel advantage guarantees Luc&Bel production efficiency: it’s tie-bar-less technology. Thanks to their tie-bar-less clamping units, changing the mould on the Engel victory injection moulding machines is easy and can be done very quickly. In addition, relatively small machines are able to accommodate large moulds. For multicomponent processes and the integration of assembly steps in particular, large, bulky moulds are often required, but in combination with relatively low clamping forces. The tie-bar-less technology helps to reduce operating costs here and, in effect, unit costs.

“We focus on products with a high added value,” stresses Ferrari.

Among other things, components for intravenous infusion, dialysis and heart surgery are currently being manufactured for customers.

Many products are assembled as soon as the injection moulding process has been completed, so there is an automated assembly cell, the first of its kind, right next to the injection moulding machines in the clean room.

Short distances are the hallmark of Luc&Bel’s production concept.

Parallel to the injection moulding machines in the clean room are the systems supplying the granules in a corridor separated from the clean room. This is also where the sprue granulators are. In closed systems, high-quality materials are turned into regranulate.

Luc&Bel currently employs 14 staff in Carpi, but another ten employees are expected to be added to the team in the medium term, with a view to reaching a turnover of ten million euros. “We have analysed the market very carefully and are sure we will achieve this target,” says Ferrari. “We concentrate on highly innovative products and integrated manufacturing processes, which gives our products and, in turn, our customers an edge over competitors.

JULY - AUGUST 2014 / MPN /29

Stand D48

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 www.distrupol.com

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SPONSORED BY

Small

wonder

How can micro parts be produced by a small footprint machine that is designed to use as little energy as possible, optimise the properties of melted plastic, reduce material wastage, and reduce contingent tooling costs? Enric Sirera reveals innovation in micro moulding for medical OEMs << Figure 2 >> Dosing unit

Ultrasonic unit Sonotrode / Horn Tool Automation - pick & place << Figure 1 >>

INJECTION MOULDING Abstract Over the course of the last few decades, the technology of plastic injection moulding, and its more recent development into the area of ‘micro’ injection moulding has seen little in the way of radical re-interpretation and evolution. Recently, a new and innovative approach to micro moulding has been introduced and commercialised that reinvents the entire process. This opens up significant advantages for medical device OEMs in terms of the costs of manufacture and the possibilities that now exist in terms of product design due to the characteristics of the process. With an ability to reduce melted polymer to the viscosity of water, ultrasonic micro moulding heralds a new dawn for the design and manufacture of micro plastic parts.

Summary Across industry in general, but in the medical industry in particular, the drive in terms of product and component design is towards miniaturisation. In the medical sector, beyond the usual industrial desire for use of less material and weight savings, miniaturisation is driven by the desire on behalf of medical product manufacturers to produce products that allow for ease of implantation or that facilitate surgical procedures with minimal invasiveness.

Of course, there is a trade off between miniaturisation and the actual function of a medical product. Smaller and smaller is not always better and there are limits as to the extent to which medical products can be reduced in size and still produce optimal patient outcomes. A few argue that there is a danger in some instances that the oft quoted design mantra that “form should follow function” can become lost as medical product designers continually strive for miniaturisation. But in general terms, medical designers are forever pushing the boundaries of increased precision and reduced size in balance with part functionality and user ergonomics.

There are particular areas where continued requirements exist for efficacious parts that are as small as possible, for example in various in vivo diagnostic applications such as embedded sensors, in the development of intravascular ultrasound catheters, and for numerous micro-invasive technologies treating a variety of chronic medical conditions.

Whether product designers are focused on such cutting edge developments, or are striving for miniaturisation in other areas of medical product development, very often there is a limit on product design parameters from the nature of (and availability of) cost-effective manufacturing alternatives.

In the area of micro plastic part manufacture, until recently, these parameters have been dictated by the nature and capabilities inherent in micro ‘injection’mmoulding. Today, however, a new and innovative technology for the manufacture of micro plastic parts is making some waves in various industry sectors, and is forcing product designers to re-evaluate the limits on what is now possible.

Continued on page 32 JULY - AUGUST 2014 / MPN /31

Moulding plastic parts The history of plastic moulding is a long one, actually stretching back to the 1870s. Early machines were manual, and it was not until the 1930s that electric machines began to be developed.

The injection moulding machines that many people relate to today, with screws and barrels have been used commercially since the 1950s, with fully electric machines coming into existence in the early 1980s.

For much of its history, plastic injection moulding has evolved through variations on a theme. The basic underlying process of plastic pellets being placed in a hopper, melted in a hot runner, and then injected into the mould has remained the same.

Indeed, when looking at developments in the area of moulding ‘micro’ plastic parts, what can be seen is a migration of ‘macro’ injection moulding technologies to cater for the manufacture of micro parts, and therein lies the potential for huge inefficiencies in terms of energy usage, material wastage, and unnecessary and expensive tooling.

For the first time in the history of plastic moulding, a new approach has been commercialised that uses ultrasound as the agent of material melting, and which has been developed specifically for the manufacture of micro parts. The technology approaches the manufacture of micro plastic parts from a completely different perspective. How can micro parts be produced by a small footprint machine that is designed to use as little energy as possible, optimise the properties of melted plastic, reduce material wastage, and reduce contingent tooling costs? From this perspective, an innovative technology and solution to micro plastic part manufacture was developed and is now offering numerous hitherto impossible opportunities to medical product designers.

Ultrasonic Micro Moulding The company behind the development of the ultrasonic micro moulding technology is Barcelona-based Ultrasion, and the machine being sold worldwide is the Sonorus 1G (see figure 1).

What is most obvious when looking at the technology is that there is no barrel and screw. In this technology, ultrasonic waves are used to melt plastic granules that are fed direct to the mould, and are melted in milliseconds once contacted by an ultrasonic horn. The technology was developed through years of research and development at the industrial research group ASCAMM in Barcelona, which attempted to marry an expertise and understanding of the versatile nature of ultrasonics in various industrial applications to the particular draw backs and issues that were confronted when attempting to mould plastic at a micro level.

The basic constituents of the ultrasonic moulding process are shown in figure 2. The machine has a dosage system that delivers the correct quantity of standard pellets for every shot. The production cycle begins with the mould already closed and dosed with raw polymer at room temperature. The material is then contacted by an ultrasonic horn or ‘sonotrode’ which is lowered, and as well as melting the polymer forces the material to flow into the mould cavities. The sonotrode then returns to its original position, and the cycle begins again.

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<< Figure 3 >>

Advantages for medical part design and manufacture In essence, the Sonorus 1G is a technology solution for plastic micro part production that has been designed for this purpose and which has sought to address many of the problems associated with traditional micro ‘injection’ moulding.

Very often, micro injection moulding suffers from the fact that the technology requires high moulding pressures, which means that the technology solution is oversized for the manufacture of micro plastic parts. Also, the micro ‘injection’ moulding process — using as it does electrical heater bands — is extremely energy inefficient, (running continuously at 1.7 kW/h) and such a heating process and the speed of material injection required leads to significant raw material degradation.

Add this to the inherent complexity and cost of traditional micro injection moulding machines and the various necessary peripherals, and the process can be costly and restrictive in terms of micro part manufacture.

Ultrasion’s ultrasound micro moulding technology is outstandingly precise, uses no heaters, and the process means there is no material residence time, and no material degradation.

Also, as energy is only imparted for a split second when the ultrasonic horn contacts the raw polymer to induce melt, the technology uses up to 90% less energy than traditional micro plastic moulding.

Perhaps of paramount importance, however, especially for medical part manufacture where raw materials are often disproportionately expensive, is the reduction in material waste.

Material wastage using traditional injection moulding technologies can be a huge problem when making micro parts, with in some instances 99% of material processed being scrapped. In the ultrasound micro moulding process, only the material required is dosed, and so runner and sprue wastage is minimised.

Also, the ultrasonic moulding technology requires low moulding pressures and is highly replicable, much of this being due to a specific characteristic of the process that opens up countless possibilities for medical product OEMs as they attempt to overcome obstacles in the manufacture of micro plastic parts.

Opening up product innovation This particular characteristic is that materials melted via ultrasonics exhibit significantly reduced viscosity, allowing the production of thinner walled, flatter, and longer parts than has ever been achievable before.

It is not just the use of ultrasonics that reduces fluidity. The new

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sprue concept in the Ultrasion technology means that it behaves as an energy director as well as part of the ejection system. The energy director orientates the waves in the flow direction, therefore the molten material and waves travel together toward the cavities, reducing the viscosity of the polymer.

It’s all about applying a high intensity mechanical vibration that transmits energy directly into the polymer molecular structure resulting in a very fast and efficient melting ‘inside-out’ rather than ‘outside-in’ which is typically how melting occurs in injection moulding via electric heaters.

In real terms, this particular characteristic of the ultrasonic moulding process means that 15 mm long parts with wall thicknesses of 0.075 mm are easily attainable. Achievable tolerances are as tight as 0.01 mm.

The Sonorus 1G accommodates shot weights from 0.05 g to 1.5 g, and is being used across the world by various OEMs in the medical and other industry sectors. The proprietary nature of many of the applications of the technology are such that precise case studies are not possible, but it is possible to give some details of recent OEM projects and the materials used and dimensions achieved.

The first was a healthcare project for a medical device using coloured polypropylene. This tissue management application required a particularly difficult to manufacture tip. By using the Ultrasion technology, this OEM managed to produce a tip that was 43 mm long, weighing 0.22 g, with wall thicknesses of 0.075 mm, and with an outside diameter of 0.35 mm and an inside diameter of 0.2 mm.

In another application for the manufacture of a cap with a filter for an ear protection device made from raw polyamide 12 (PA12), the ultrasonic moulding process successfully manufactured a part weighing 0.02 g, with a 0.5 mm wall thickness, and outside diameter of 4.4 mm and an internal diameter of 2.9 mm. Of enormous interest with this part (see figure 3), was that the part — with a membrane overmoulding — was achieved in one operation. This proved impossible to achieve using a conventional micro injection moulding process, the alternative to Ultrasion’s ultrasonic moulding process being to mould the part using one process, and then to glue the membrane in a secondary process. The manufacturer reported a 300% increase in productivity using the Ultrasion technology.

INJECTION MOULDING

bottom line is that Ultrasion do not know what the limits are. In the case of the ‘tip’ part mentioned above with 0.075 mm thickness along 15 mm with PP, when working on this project, Ultrasion generated flashes at the top of the tip due to a mould misalignment. The company has been unable to measure such flashes precisely, but they are definitely at least as thin as 0.003 mm along 3 mm. The customer was astonished as they felt that PP was not supposed to flash at such thicknesses, and this led to the development of parts that it had previously thought impossible to manufacture.

Conclusion For any new technological development to enhance the existing manufacturing environment, it must of itself contain significant advantages, and also open up design and manufacturing possibilities previously unattainable.

Ultrasion’s new ultrasonic micro moulding process is one such technology that is beginning to redefine the parameters that were deemed to be in place when looking to manufacture micro medical plastic parts. This technology represents a new and innovative approach to micro plastic part manufacture, and as an alternative to traditional micro-injection moulding technologies exhibits significant advantages in terms of power consumption, reduced material wastage, and reduced tooling costs.

Perhaps of most interest, however, is that the nature of the process, and especially the reduced viscosity characteristics that ultrasonics can achieve as the melting agent, opens up the possibility of part design and part characteristics that have hitherto been unattainable. It is here that the interest that Ultrasion is attracting from OEMs across industry is focussed, most especially in the areas of medical devices and microfluidics.

About the Author Enric Sirera is the sales director at Ultrasion.

Finally, ultrasonic moulding was successfully used in the production of an eye retina surgery tip (see figure 4) made from raw polypropylene. The final part weighed 0.1 g, had an internal diameter of 0.6 mm with a 0.17 mm wall thickness, and a wall thickness at the tip of 0.1 mm. The tool for this application used two extremely small core pins sitting head to head which would have broken using the high pressures of conventional micro injection mouding.

While these achievements are in themselves impressive, the

JULY - AUGUST 2014 / MPN /33

High five Daniel Benze, Forefront Medical Technology explains the five ways your injection moulding supplier can take time and cost out of product development edical device manufacturers are under continuing pressure to cut cost while delivering superior quality. A well-organised product development process that taps contract manufacturer resources can reduce time and overall manufacturing cost. Involvement of the injection moulding supplier is key, because this manufacturing ‘expert’ is well positioned to reduce a number of major cost drivers. The injection moulding supplier business model has evolved to include many of the services more broadly defined as ‘contract manufacturing’.

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processes. Computer analysis minimizes design iterations on tooling. The mould fabrication process includes a testing and debugging phase which incorporates a dry run and analysis of product (FOT) first off the tool.

Design assumptions related to target labour utilisation and run rate are evaluated during the validation process. All data is shared with the customer, for their approval. Changes are made if that analysis indicates assumptions were flawed. Production processes undergo a similar development and validation phase.

The product development team at Forefront Medical Technology has average product development cycles of eight to nine months. The team attributes its success in regularly shortening product development cycles and reducing overall cost to focus in five key areas: Materials selection; design process; tooling design and fabrication; prototyping; validation infrastructure.

Prototyping Taking an integrated approach to rapid prototyping contributes to reduced product development time. For example, this contract manufacturer’s use of Selective Laser Sintering (SLS) and Multi-Jet Modeling (MJM) systems in rapid prototyping cuts lead-time in the product validation process. In-house resources are used to scale up moulds and tools, and perform pilot runs and validations.

Materials selection Using materials that have previously been tested and approved within the regulatory environments associated with the product can cut months from a product development cycle. Forefront often eliminates up to one year of development time, when materials from its database that have been previously approved are used. In this contract manufacturer’s process, customer requirements are assessed and a Design Development Plan (DDP) is created. A customer specification is developed and market inputs collected. Once the specification is approved, 3D CAD models are developed and analysed. Design reviews which include functional analysis and risk evaluation are completed. Once the customer’s team approves design, prototyping and verification began.

Tooling design and fabrication One benefit of using a tooling development team that is part of a moulding supplier rather than a standalone tooling firm, is that it ensures the design process aligns with production processes. Tool complexity tradeoffs can be analysed to develop the best tool for projected volumes, minimisation of secondary processes and cost targets. The earlier manufacturability issues are analysed in tooling development, the less expensive the tooling design modifications will be. Working with a design team that is analysing the design for manufacturability early in the product development process eliminates added design spins, enhances quality and minimises non-value added processing. Also, vertically integrated tooling capability can also cut time from the design cycle.

This contract manufacturer utilises a gated design process to enable tooling development to begin as early in the design process as possible.

Taking a vertically integrated approach to tooling fabrication and use of in-house resources often cuts another two to three months off of product development time. The tooling design process includes a design for manufacturability (DFM) phase, followed by development of the mould specification.

Mould-flow analysis tools are used to ensure efficient moulding with minimal scrap and minimization of secondary finishing << In focus: According to Forefront Medical cutting time and cost from the product development process requires focused expertise >>

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Validation infrastructure One of the most challenging aspects of the medical device market is meeting the regulatory requirements of different markets. The high level of automation associated with many disposable medical products makes sourcing regionally less cost competitive. Working with an injection moulding supplier capable of supporting a global device marketing strategy in terms of validation testing and quality infrastructure saves time and improves economies of scale. For example, this manufacturer has a Regulatory Affairs team whose responsibilities include product registration and CE marking; maintenance of the Device History Record (DHR) and technical file; biocompatibility testing; validation and support sterilization; updates on regulations and communication of new/revised regulations; and intellectual property protection.

Overall, cutting time and cost from the product development process requires focused expertise and robust systems. That investment typically provides dividends in terms of cost competitiveness and superior quality that continue over the full product lifecycle.

INJECTION MOULDING

SPONSORED BY

Print works Nadav Sella, solutions sales manager, Stratasys, outlines the benefits 3D printing has brought to injection moulding

3D

printing has been around for 25 years with the technology jumping from being solely a tool used in product development in the design cycle to one deployed across the supply chain in almost all walks of life, including the production of injection moulds.

Traditionally, hard-tooling moulds are made from tool steel with a CNC milling machine or via electrical discharge machining (EDM). When used in mass production, they can last for millions of cycles but cost hundreds of thousands of pounds. What’s more, lead times to produce these moulds are often measured in months rather than weeks or days.

When tens of thousands of injection moulded parts are needed, soft-tooling is an option. Made in aluminium, these moulds are less expensive and faster to produce (two to six weeks).

Unfortunately, the cost and time of tooling moulds is often compounded by factors like design mistakes that require the mould be remade correctly or the need to create multiple iterations before the final part design and quality are achieved. It is with these issues in mind that manufacturers have begun to embrace the use of 3D printed moulds to create functional injection moulding prototypes.

As such, we are witnessing an exciting development in the world of injection moulding whereby companies are beginning to adopt 3D printing for << Expert opinion: According to Nadav the production of Sella we are witnessing a development tools for low volume in injection moulding as companies adopt production.

3D printing for the production of tools Advances in Stratasys’ for low volume production >> PolyJet materials portfolio, namely its Digital ABS offering, has enabled companies to take functional testing to a new level. The ability to 3D print tools that can withstand the heat and pressure of the injection moulding process, to create prototype parts in the final product material, enables companies to generate superior performance data and validate certification confidence.

How is this affecting the medical device sector In a field where innovation saves lives, Stratasys 3D printers empower doctors, researchers and medical device manufacturers to work faster, test thoroughly and customise their devices in new and innovative ways. Beyond the traditional notion that 3D printing is very much a prototyping tool, manufacturers are now realising that more benefits are available to them further down the product development process, including the ability to 3D print injection moulding tools.

PolyJet injection moulds are often cheaper and much faster to make compared with traditional aluminium moulds. The PolyJet 3D printed injection moulding tools do not replace traditional aluminium and steel tools but in many cases, they can be used to obtain the first batch of injection moulded parts, giving customers flexibility in their manufacturing process, saving time and money.

The medical device market is demanding in terms of the number of tests and documentations needed before a product can be released to the market, as well as the special materials that are being used. This makes the lead time reduction with 3D printed tools even more crucial, especially when medical device prototypes can be tested in the final product material before committing to CNC machining.

3D printing injection moulds allows manufacturers easy evaluation of the performance, fit and quality of potential products before mass production starts. If design iterations are required, they can be made in a matter of hours and at a fraction of the cost compared to traditional moulds.

A great example of the tooling benefits afforded by PolyJet technology is Diversified Plastics, a US custom injection moulding company that serves numerous industries including medical.

Recently, a medical customer approached it about producing a new medical device that it wanted to bring to market quickly. By using its Stratasys 3D printer to create the mould, Diversified Plastics was able to produce an injection moulded prototype from the same material planned for the final product in one week instead of five ― a time savings of 80%. This allowed the customer’s R&D and marketing departments to evaluate and test the shape, texture, look and feel of the device far faster than in the past.

What’s more, by 3D printing the injection mould, Diversified Plastics cut its tooling cost by 88%.

What the benefits will be in the future This is a fast-growing application and Stratasys continues to work with companies to help them gain new manufacturing efficiencies with 3D printing technology. Plus, with increased improvement in 3D printing materials, the ability to create customised and complex bio-compatible parts and devices may someday become reality.

JULY - AUGUST 2014 / MPN /35

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INJECTION MOULDING

SPONSORED BY

Who : Injection moulding specialist Neptune Engineering Technology

What: Has reduced lead times and costs for its medical sector customers

How: By investing in Sodi-Tech EDM technology

Best invest

N

eptune Engineering, a Hertford-based injection moulding and toolmaking specialist has invested in the latest Sodick wire and die sink technology from SodiTech EDM to help spur growth at the manufacturing business. A Sodick AD30L die sink EDM has replaced a 20-year-old model, while a Sodick VZ300L wire EDM has eliminated the need for subcontracting, reducing both lead-times and costs. The company’s medical sector customers are among those set to benefit – medical work accounts for the largest proportion of business at Neptune, commanding around a third of total business revenue.

Among the medical sector tools produced at Neptune Engineering are devices to help patients get the most from their PMDI (Pressurised Metered Dose Inhaler).

Although boasting 40 years of history, the outlook changed for Neptune Engineering in 2010 when Gary Statham took over the business from his father. He relocated the company almost immediately to much larger premises (double the size) and in the subsequent two years invested in new CNC machining centre technology along with the latest CADCAM software. In late 2013 this was following by a project to source new wire and die sink EDMs. The investments have certainly paid off – in the time since Statham took the reins at Neptune Engineering the company has tripled its turnover.

The Sodick machines at Neptune are largely programmed offline, although Statham says online programming is also used because the “Q&A style of programming on the Sodick control is very good”. In total, three operators at the company are trained to use both Sodick machines.

“Before coming here in 2010 I worked for a successful mouldmaking business in Buckinghamshire which was benefiting from the use of Sodick EDM technology,” says Statham. “Because the existing die sink machine at Neptune was 20 years old we had to subcontract our wire requirements. This situation couldn’t continue if we were to meet increasing demand for shorter leadtimes and ever-greater precision – I knew a pair of new Sodick machines would help us move forward.”

“If you have an inferior EDM it is probably still possible to make basic tooling using manual skills,” says Statham. “However, for more complex moulds it is difficult to hold accuracy of 0.01mm.

This is one of the main reasons we invested in Sodick technology – because precision is guaranteed. As a result, we no longer only produce single-impression prototype tools, but multi-impression moulds for large, blue chip organisations.”

“The market remains tough but we are busy with good visibility looking forward, which is a real success this industry,” says Statham.

“Ultimately, if you produce good work and hit delivery dates, customers will come back – customer satisfaction is paramount and has helped the company earn its reputation. Our new Sodick machines are now a vital part of this ethos.” << Two’s company: ‘I knew a pair of new Sodick machines would help us move forward,’ says Gary Statham, Neptune Engineering >>

“The finer the finish, the more electrode wear you expect,” says Statham. “However, the electrode wear using our new AD30L is around five times less than what we achieved using our older machine. Some of the moulded parts we make for the medical industry are the size of a thumbnail or smaller, and customers here ask for what is known as ‘zero surface finish’. But the finish on the AD30L is so good that there is no need for polishing operations.

“We manufacture single impression prototype moulds for some of our medical industry customers and need to respond to demands for short lead-times, typically four weeks or less, which means our Sodick machines are kept extremely busy. In fact, since they were installed in October 2013, we’ve only had one day of downtime. Of course, we have also seen part complexity increase dramatically in recent years with customers asking for more curves, angles and radii, but none of this is a problem for the Sodick machines.”

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READY-TO-FILL

Point of interest The Gerresheimer Bünde facility is continually growing. As well as boasting a new building complex, a fourth production line is being commissioned. With around 800 employees this is Gerresheimer’s Group’s competence centre for ready-to-fill glass syringes

W

hen you seen the new building complex at this Gerresheimer plant, it’s hard to imagine that the company was founded back in 1947 as Bünder Glas by the Hennings and Zimmermann families. Gerresheimer took over Bünder Glas in 1987 and since then it has gradually developed it into an international specialist for sterile ready-tofill syringes which are marketed under the Gx RTF (Gerresheimer Ready-to-Fill) brand name.

Glass ready-to-fill syringes are supplied to pharma and biotech customers around the world, where they are filled with pharmaceuticals. Gerresheimer has a comprehensive portfolio of sterile and non-sterile syringe systems. Gx RTF syringe systems are supplied to the customer in a ready-to-fill state - washed, siliconised, pre-assembled with cap and sterilised.

The new production bay The fourth production line for ready-to-fill syringes is currently being commissioned in the new production bay. Key process improvements include the avoidance of glass-glass and glassmetal contact through the use of pick-and-place robots and segment transport systems, optimized washing and siliconisation processes and more effective, camera-based quality inspections.

This gentle handling results in a lower syringe cosmetic defect rate. A new washing process guarantees even better compliance with both present-day and future regulatory requirements.

Improved spraying technology and 100% in-line inspections in the siliconisation process ensure consistent syringe function. All these measures improve the syringes’ processability during the filling process and their general function. The syringes from all production lines are packed into PP boxes in clean room environments to ensure maximum product hygiene.

<< On point: Gerresheimer has a comprehensive portfolio of sterile and non-sterile syringe systems >>

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The first RTF production line was installed and commissioned at the Bünde plant in 2001. Before long, the RTF syringes were a major success on the international markets.

Two further production lines were subsequently installed, followed by the fourth RTF line in Bünde ten years later. Today syringes account for the majority of Bünde’s production output, and it will have the capacity to manufacture over 400 million RTF syringes when the RTF4 line is put into operation at the end of 2014.

Bünde has 24/7 production operations because this is the only way to exploit the plant’s capacity to the maximum while maintaining stable processes and quality.

Maximum syringe quality Syringes are primary packaging products, which means that they come in direct contact with the medication. That’s why utmost care must be taken when manufacturing them. The syringe has to be perfectly clean because even the tiniest amount of contamination could alter the medication. The syringe also has to be absolutely intact. It cannot have cracks and must be firmly sealed so that no germs can come into contact with the medication.

The inside of the syringe is coated with silicone to ensure that the plunger can slide up and down it. The rule of thumb is to use as little silicone as possible and as much as necessary. You have to use enough, because you want to make sure that the plunger will slide just as easily after three years of storage. But if you use too much, it can cause lumps to form in the medication.

When syringes are manufactured, each one of them is inspected several times - by cameras, sensors, computers and the human eye. Employees have special responsibility for ensuring that no patient suffers harm as a result of defective syringes.

Gerresheimer Bünde has been equipped for successful production operations which it looks set to build upon with the fourth production line.

TESTING & QUALITY CONTROL

Customer focus Devices contract manufacturing - how does ISO 13485 secure customers? Union Plastic explains

M

edical device manufacturers have to comply with stringent regulations to access the European market.

Those European regulations are changing quickly and the coming years will see the publication of the Medical Devices directive RECAST, which will oblige the industry to make changes, regarding device master files and other issues. The first step is the implementation of harmonised standards, and the first of them is ISO 13485.

In the meantime, a new European regulation 2013/473/UE already prepares the next changes in the medical device industry.

It has applied since 2013 to all notified bodies (NB), which certify medical device manufacturers, by strengthening their responsibilities and field of investigation. Appendix II Chapter 19 of this regulation gets upstream in the supply chain, by clearly involving Contract Manufacturing Organizations (CMOs) in the final product quality. This defines critical sub-contractors, which design, manufacture or perform services for a part of the medical device, and critical suppliers, which supply essential components as raw materials and moulded parts. Those organisations shall keep under the control of their order giver and his NB, which must perform planned and unannounced audit in their premises too. For instance, if medical device manufacturer A purchases from and injection moulding company B a single component that is assembled by A in a complex medical device, regulation 2013/473/UE obliges Aâ&#x20AC;&#x2122;s notified body to audit B them versus the same standards as A. It is also stated that Bâ&#x20AC;&#x2122;s ISO 13485 certification can justify lightening such audits.

Union Plastic, a French CMO with half a century under its belt working with partners in the device, diagnostics and pharma industries, has anticipated this trend for long. Specialising in providing complex injection moulded thermoplastic parts and assembling solutions, the company renewed its ISO 13485 certification several times, which covers all its businesses and activities from the design phase to the warehousing. This certification had a positive impact on the quality management system (QMS) of the company and it also helped in becoming the contract manufacturing partner of choice for the worldâ&#x20AC;&#x2122;s most successful companies.

Being CMO and manufacturer too, talking the same language and having the same regulatory restrictions as its main customers, Union Plastic says it went deep in the implementation of the

medical device reference quality standard, with improved processes and procedures, from the product design to the final release, including batch records and qualification.

In addition to this positive implication on the company business development, typical benefits from the ISO 13485 to CMOs are: Efficient and health-focused QMS. Increased safety during the product design: Risk Management Process, according to the ISO 14971 standard, is daily used by Union Plastic for each medical device or component development. Union Plastic enlarged the use of this tool to each new part, even when it is a sub assembly of the medical device, during each critical step: design review, prototypes review, design validation, and industrialisation.

Quality Assessment is carried out over all design stages at in each product design from a very early stage, through a dedicated Quality Project Expert.

Change Control: all medical device manufacturers need to monitor and manage the activity of their CMOs. So they have to be informed about change, which impacts the component.

Having efficient and transparent change control procedures led Union Plastic to win the trust of the main order givers.

Traceability: ISO 13485 is a very good guideline to improve traceability from raw material source to finished products, records and inspection reports.

Sterile products handling: ISO 13485 is now a must when choosing contract sterilizers, especially with companies dealing with several industries like food or cosmetics.

This demonstrates, says Union Plastic, that choosing a contractor is not only a technology driven decision process. The component user has to find out a partner, which has a structured approach and knows the downstream applications of their components.

ISO 13485 is not the universal key to understand it, but it very much helps CMOs in implementing health-focused processes.

And last but not least, the 2015 release of this standard should go further in the requirements to be applied to subcontractors - this must be anticipated now says the company.

JULY - AUGUST 2014 / MPN /39

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ADDITIVES & FLUIDS

Liquid

assets

Jay Tourigny, MicroCare Medical senior vice president, looks at how a nonflammable carrier fluid can improve safety, compliance and the validation process

S

ilicone-fluid lubricants are commonly used to coat medical devices including disposable needles that are used for delivering medication or withdrawing fluids, and for suturing in medical procedures. The lubricious coating on the needle surface reduces drag forces, allowing the needle to go through the skin more easily, ultimately making it less painful for the patient.

Where medical grade silicone fluid polydimethylsiloxane lubricants is provided in concentrated form, medical device manufacturers need a carrier fluid to dilute the concentrated silicone lubricant so a very thin film of silicone can be applied to an article by dipping or spraying.

The ideal carrier fluid must have good solubility, so that the silicone oil will dilute and naturally disperse in the carrier. This allows the user to apply the dilution to a surface by spraying or dipping. The carrier fluid should also be fast drying so when it evaporates, a thin, consistent film of silicone remains as a uniform coating on the treated part.

Nonflammable carrier fluid options have always been a preferred method of application, providing low risk of fire, especially important for high-volume production facilities. While original nonflammable carrier options were low-risk, they were regulated out of production due to environmental issues. The rapidly changing regulatory landscape has made it increasingly difficult to specify nonflammable carrier fluids. Nonflammable options have all but disappeared from the market and many medical device manufacturers are considering flammable options to replace them. Both aliphatic and aromatic hydrocarbons are two

commonly used flammable carrier fluid options, but these can be difficult to use especially in high-volume production facilities because of the flammability risk. In an environment that is already prone to static discharge, it takes just one spark to start a fire due to flammable carrier fluids’ vapors. The engineering controls required to mitigate risks associated with handling flammable liquids are very expensive, and often difficult for health and safety officers to support.

With increased focus on changing health and safety concerns, the tide is turning away from flammable options due to their high risk factors.

A new, nonflammable formula is available from MicroCare Medical that provides a safe, reliable and ideal drop-in replacement to the widely used flammable carriers such as hexane or toluene. Suitable for use in the European Union and US and meeting all REACH requirements, the MicroCare Universal Carrier Fluid is a custom-blended carrier fluid with good solubility and excellent materials compatibility that has been optimised to dilute and apply medical grade polydimethylsiloxane lubricants to medical devices.

<< Fluid lines: Siliconefluid lubricants are used to coat medical devices including disposable needles that are used for delivering medication >>

Stick with it Techsil outlines its new UV curing adhesives for medical device assembly Techsil has launched three new products for the medical device market. The adhesives from manufacturers Panacol includes Vitralit 7562, a moistureresistant adhesive which maintains high adhesion after a seven day water immersion. Other introductions are epoxy adhesive Vitralit 1655 and acrylate Vitralit 4731, expanding Techsil’s portfolio of PVC and polycarbonate adhesives. Both products are said to be flexible and therefore ideal for bonding larger surfaces without inducing stress cracking. All adhesives are specifically formulated to meet USP Class VI and/or ISO 10993 biocompatibility standards and are solvent free.

These engineered adhesives can be cured within seconds with UV LED equipment: New tests have shown that in many applications it takes only seconds until the adhesives are fully cured using Hönle’s LED Powerline, featuring a high intensity at a wavelength of 405 nm. With this technology, medical devices can be assembled quickly but also bonded with an optimum precision and reliability.

Therefore, the adhesives are perfect for applications such as needle bonding, assembling polycarbonate housings from dialysis filters or blood oxygenators, and joining flexible tubing to plastic connectors. The bonded joints ensure utmost stability and resist high extraction forces. This high strength is maintained after undergoing several sterilisation cycles. Panacol’s fast-curing adhesives for disposable medical devices can be assembled quickly and safely while keeping production costs low. << Let there be light: These engineered adhesives can be cured within seconds with UV LED equipment >>

JULY - AUGUST 2014 / MPN /41

POLYOLEFINS

Film star

Medical applications for polyolefin films by Sunil Inamdar, Polyzen director of technology Polyolefins in medical applications Polyolefins are used extensively in the medical industry due to relatively low cost and unique performance properties, including chemical resistance, inertness, and light weight. The two most common polyolefins, polyethylene (PE) and polypropylene (PP), are used in applications ranging from syringes to storage bags.

A hallmark of polyolefins is their ease of melt processing.

Polyolefins can be extruded, blow moulded, injection moulded, and thermoformed. However, bonding polyolefin components can be challenging. Adhesives and solvents are largely ineffective due to the outstanding chemical resistance of these polymers. While heat bonding is a preferred alternative, unique thermal characteristics of polyolefins can present challenges for precision welding of medical devices.

Film-based polyolefin constructions Medical bags, protective sleeves, wound care, and numerous other applications have been constructed from polyolefin films for years. In recent times there has been increasing demand for polyolefin replacement of polyvinyl chloride (PVC) films due to concerns about toxicity and plasticizer leaching. Low density PE film does not require plasticisers to achieve comparable flexibility to PVC and is more economical than some ethylene vinyl acetate (EVA) or thermoplastic polyurethane (TPU) alternatives.

Film-based medical constructions, such as bags or sleeves, require welding film. This is most commonly done using radio frequency (RF) thermal heating. Polyolefins can be more difficult to RF weld than PVC; however, multi-layer polyolefin films that incorporate polymers with improved welding performance have been used to overcome this limitation. New grades of polyolefins have also been developed in recent years, specifically to improve welding.

The challenge of film welding polyolefins has been further complicated by medical device companies decreasing wall thicknesses in film-based constructions. Thinner walls reduce product weight which can improve functionality, handling and environmental impact when disposed. However, thinner walls require greater precision in welding to avoid overheating seams.

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Material selection, film thickness and weld quality are interrelated variables in these applications. It is not uncommon for development to include multiple iterations between materials and processes. Since early stage development requires evaluation of polymer candidates through the entire process of film extrusion and RF welding it is advantageous to have these processes in close proximity. This can speed development time and overall time to market by reducing time between iterations.

Comprehensive development partner model In today’s highly competitive medical marketplace, innovation and speed to market is essential to survival. Many medical companies are focusing on new product designs and are relying on outside vendors to provide material recommendations and processing expertise. At the same time, these companies are seeking to reduce the number of qualified vendors. Modern suppliers are being challenged to provide comprehensive technologies that support the entire product life cycle, from prototype to production.

Polyzen provides an excellent example for modern vendors of film-based medical constructions. The company offers expertise in polymers and custom formulations that minimizes development time by selecting the right material to meet performance and process requirements.

For film extrusion, Polyzen offers comprehensive capabilities that include flat die extrusion, co-extrusion, coating and laminations, and multi-layer constructions. Extrusion equipment is designed to produce films in widths up to 52 inches (132 cm) and thicknesses ranging from 0.0005 to 0.070 inches (0.0127 to 1.778 mm), with in-line x-ray gauge reporting. All of these processes can be performed in a class 10,000 cleanroom environment.

Within the same facility Polyzen offers precision RF film welding utilising dielectric heat to seal very thin, hairline seams. This process can weld two or more layers of thin films together when making low pressure balloons, bags, and barrier sleeves for medical device assemblies. It is also a versatile process that can be used for welding low volume prototype quantities and high volume production levels.

PLASTICISERS

Stéphane Content, sector group manager of The European Council for Plasticisers and Intermediates (ECPI), discusses how plasticisers have been making PVC flexible for medical applications for decades Perhaps because they are not the glossiest or the most celebrated of materials, recent evolutions in the plasticisers industry may have gone unnoticed in the medical sector. Items made of flexible PVC containing plasticisers are found in rooms and corridors of medical facilities all around the world. They are essential components of life-saving applications such as tubing, dialysis, endotracheal, feeding and pressure monitoring, catheters, blood and urine bags, gloves, mattress covers as well as flooring and wall coverings.

Medical PVC products were originally developed as replacements for natural rubber and glass. Their low cost, safety, high performance and versatility to manufacture single-use devices resulted in a revolution in the sixties. Today, almost 30% of all plastic-based pre-sterilised single-use medical applications used in hospitals are made from PVC.

<< Bend it: Items made of flexible PVC include tubing, dialysis, endotracheal, feeding and pressure monitoring, catheters, blood and urine bags >>

substances, DEHP, DBP, BBP and DIBP, are on the Authorisation List. This means that after February 2015, these four substances can be placed on the EU market only for those uses for which an authorisation has been granted to specific applicants.

Plasticisers in medical applications In the medical world, the most commonly used plasticiser is di (2ethylhexyl) phthalate, known as DEHP or DOP, which is commonly found in medical bags containing blood and other intravenous solutions. However, as regulatory, market pressure and controversy have been increasing around this plasticiser, a number of alternatives have been developed by the industry.

Demand has been shifting away from LMW towards HMW which today represent around 85% of all phthalates being produced in Europe. At global level, the trend is quite different and DEHP still makes up for around 50% of all phthalates used worldwide. The market for alternatives to phthalates is fast developing all around the world.

Substances used in medical devices are exempted from REACH authorisation for human health aspects although this may be about to change as the European Parliament is working on a revised Medical Devices Directive which may ban CMR and endocrine disrupting substances. A second vote is expected for the next parliamentary term after the European elections in May 2014. In addition, recycling of non-infectious DEHP-containing material could become more burdensome as there is no clarity if REACH authorisation or the EU waste regime is to be applied.

Pioneering recycling The majority of PVC medical devices are ‘single-use’ products.

Medical waste is generally managed through incineration.

However, recent experiences have shown that recycling of medical waste has the potential to be successfully implemented in healthcare settings like hospitals, contributing to smart use of resources and improved cost-efficiency. Currently, there is one project running in Australia where sorting and recycling systems are in use to recycle non-infectious hospital PVC waste.

There are many other plasticisers employed in the PVC flooring and wall coverings installed in medical facilities. Those applications have the characteristic of an absence of joints that makes for a smooth continuous surface without any gaps where harmful bacteria, fungi or other pathogens thrive. This is a desired property in buildings requiring high levels of cleanliness such as hospitals and clinics but also in schools or sports centres.

In Europe, the PVC Industry runs the VinylPlus sustainability program, which has a strong focus on recycling. In 2013 alone, over 440,000 tonnes of PVC were recycled. The use of lead leadbased stabilisers in the EU-27registered a decrease of 81.4% compared to 2007 levels.

European trends and developments Phthalates – are the most commonly used plasticisers. They are broadly divided into two groups – high (HMW) and low (LMW) – according to their molecular weight. They have very different applications and legal EU classification.

Twelve LMW phthalates, classified as Category 1B reproductive agents have been identified as Substances of Very High Concern (SVHC) and placed on the REACH Candidate List. Four of these 44/ MPN / JULY - AUGUST 2014

The future of plasticisers The plasticisers’ manufacturers have been continuously investing to provide safe and reliable products which can satisfy the needs of tens of thousands of companies throughout the supply chain.

Ensuring that the importance of plasticisers is well understood amongst all stakeholders remains a key challenge for the sector in medical applications and beyond. The industry will continue working to provide the information needed by policy makers, regulators and users on the many benefits of using flexible PVC in order to cope with current and future challenges.

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

School of thought Who are you and what do you do?

My name is Payam Zachkani and I am a graduate student and research assistant at the University of British Columbia (UBC), Vancouver, Canada. After my undergraduate studies at University of Tehran, I moved to Canada to obtain a Master of Applied Science in Mechanical Engineering under the supervision of professor Mu Chiao. Currently I’m a member of the Microsystems and Nanotechnology group (MiNa) which consists of several research groups that focus on Payam Zachkani is a development and testing of small systems known as graduate student has very MEMS devices (Micro-Electro played a pivotal role in a Mechanical Systems). Here at range of innovative device the UBC MEMS Lab, our main is on biomedical projects including a focus applications of such small battery-less drug delivery devices.

implant small enough to be implanted inside the prostate through a needle

What projects / developments have you been focussed on recently During my early days at UBC, I was working on a microvalve system and later on a drug delivery implant for the treatment of diabetic retinopathy. A few months into my program, I started my research project: designing, fabrication and testing of a very small drug delivery system that could be implanted inside the prostate in order to treat/slow down prostate cancer. Almost 15 months have passed since the start of this project and today we have working prototypes.

Describe your latest innovation?

Two major obstacles in successful commercialisation of current MEMS drug delivery implants are the size of the devices and their reliability; these devices are still too big to be implanted and doubts exist regarding their performance when implanted. The main culprit is the on-board battery which dominates the size of the device and has limited lifetime. Eliminating battery and associated circuitry from biomedical implants not only makes the device simpler, but also shrinks the size of the devices and enhances their reliability.

We have developed a battery-less drug delivery implant that is small enough to be implanted inside the prostate through a needle.

This minimally invasive procedure eliminates the need for intensive surgery for implantation. This device can provide localised and ondemand drug release for extended periods of time with exact control over drug dosage, avoiding side-effects caused by common localised prostate cancer treatments (such as radiation, prostatectomy or systemic chemotherapy) while providing specific release profiles tailored to each patient’s needs.

Our device releases drug when an external magnetic field is applied. Despite its small size, it holds enough drugs to release for several months. The device is made of biocompatible materials and after implantation, there is no need to remove the device from the prostate.

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<< Student union: Student Payam Zachkani has been involved in the development of a prostate drug delivery implant that has the potential to be used for other types of low-stage localised cancer >>

What does it mean for the medical sector?

Prostate cancer is the most common type of cancer in men and it’s the second leading cause of cancer-related deaths in developed countries. Current treatments for localised prostate cancer (including surgery and radiation therapy) have side-effects causing patient morbidity. Therefore, most patients diagnosed with low-risk and low-stage prostate cancer go through active surveillance, (ie. monitoring of the tumour until signs of cancer growth are observed) to avoid overtreatment. Implanting a remotelycontrolled drug delivery device into the prostate in such patients can prevent the cancer from further progression into a more aggressive stage while avoiding most side-effects caused by current treatments.

The size and the shape of our device allow for implantation through a needle with minimally invasive procedures allowing for reduced side effects associated with full prostate removal. This device provides localised drug delivery directly to the prostate, minimising drug interactions with other tissues and potentially it can have fewer side effects than systemic administration of docetaxel for treatment of localised tumours in chemotherapy. The results show reproducible drug release rates. The amount and the time of release can be controlled to match with the specific physiology of each patient. This device can be added to the active surveillance strategy in prostate cancer management, to prevent or slow down cancer progression in patients who have low-risk localised prostate cancer. Although the main objective in this project was to design a system specifically for prostate cancer, this concept would be equally feasible for the treatment of some other types of low-stage localised cancer or other chronic diseases.

Plans for the future After getting my degree, I plan to join industry and gain some outof-school experience. I am actively looking for job positions in this field. My ultimate goal is to start my own company, preferably in the biomedical area, to promote public health and well-being. For me, this would be the achievement of a life-long dream.