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MPN
MEDICAL PLASTICS NEWS
The heart and soul of Phillips-Medisize is our people
2014 has been our best year ever and we expect that trend to continue
Phillips-Medisize
EXCLUSIVE 50 years of success
ALSO: COMPAMED Bioabsorbable polymers Industry opinion
ISSUE 21 November-December 2014 WWW.MEDICALPLASTICSNEWS.COM
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Contents NOVEMBER-DECEMBER 2014, ISSUE 21
Features 23. Spotlight . . .on the SPE
26. Micro Moulding
Regulars 5. Comment Innovation zone
15
Aleksandra Jones talks to Aaron Johnson, Accumold
Lu Rahman looks at the extent to which the medical device sector continues to innovate
31. Cleaning & coatings
7. News analysis
Featuring Forward Technology and IPG Photonics
Expertise in MicroCare Medical
35. Welding
Medical device regulations
8. Digital spy Stay in touch with the digital happenings of the industry
46 45
39. Bioabsorbable polymers Juan Granada, SCI, talks about the potential for bioabsorbable devices in interventional cardiology
10. News profile 42. Compamed
DMS and Eastman in the spotlight
Highlights of this key event
15. Speech therapy Joe Hage, Medical Devices Group on LinkedIn, offers advice for successful social networking plus Bayer MaterialScience Q&A
45. Opthalmics
18. Cover story
51. Innovation
48. PEEK Polymer expertise from Invibio
Fifty years of Phillips-Medisize exclusive
21. Designed for life Daniel Daryaie, Materialise, discusses the 3D printing revolution in personalised healthcare
62. Beady eye
At the University of Leeds
41
53. Plastics & Rubber in Compounding Expertise from Plastics Color Corp and Compounding Solutions
57. Injection Moulding
Neomi Bennett, inventor of the multi award-winning Neo-Slip, outlines her success
NOVEMBER - DECEMBER 2014 / MPN /3
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EDITOR’S COMMENT
CREDITS
The innovation zone
editor | lu rahman contributing editor | aleksandra jones advertising | mandy o’brien
S
ometimes stories appear that interest all of us and that we all become interested in. One of these resonated with the public recently with the news that a paralysed man is now able to walk again following therapy that involved transplanting cells from his nasal cavity into his spinal chord. For many, it highlighted the extent to which medical science is developing; for others it almost seemed unbelievable that such a procedure was actually possible. Working in the life sciences sector, it’s often incredibly easy to become complacent about the way in which science is addressing the very real and pressing health issues of all of us. Medical devices in particular are responsible for improving the health and wellbeing of individuals across the globe and sometimes, we take them for granted. Recent examples of innovation include Jordan Conway from Aberdeen University who is in the process of developing a material that will enable quick and successful bone repair, replacing the need to harvest the patient’s own bone. This technology has the potential to treat many thousands of patients who need spinal fusion surgery for back pain, or repairs for traumatic bone injuries. We also have AlterG, the company behind what is said to be the only wearable, battery-powered robotic device that senses the user’s intent to move and responds accordingly. It’s almost the stuff of science fiction to the general public but to those involved in the medical device sector, it’s an ongoing extension of the innovation that’s taking place on a regular basis. And it isn’t just long term development that’s going on. Research and development is occurring at such an extensive level that when the Ebola outbreak, for example, began to take hold, one manufacturer was able to respond swiftly with a device that was used for the first time on a patient infected with the virus.
These are only a few examples of the scientific breakthroughs that are taking place that make it into the media. For those of us reading about medical advances on a daily basis, they are part of a considerable and not-to-be underestimated array of developments in the life sciences sector that benefits us all.
publisher | duncan wood
As we head towards the end of the year, it’s refreshing to leave behind us positivity and a sense of achievement. Next year MPN will be very much interested in the innovation and forward-thinking approach of the industry, so keep it flowing and keep us informed of it.
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
art | sam hamlyn
subscription enquiries to subscriptions@rapidnews.com
Recent examples of innovation include Jordan Conway from Aberdeen University who is in the process of developing a material that will enable quick and successful bone repair
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
© 2014 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) NOVEMBER - DECEMBER 2014 / MPN /5
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NEWS ANALYSIS
www.cimedtech.com
EU regulations for medical devices — what does it mean? Brett Rowland and Magdalena Gray, Eversheds LLP, outline the changes to the law on medical devices in the EU and what this will mean for manufacturers
T
he recent vote in favour of new regulations for medical devices demonstrates a commitment to a more transparent and synchronised approach by the European Union. In turn this seeks to restore public confidence after a turbulent period in the industry. However, with this broader scope comes a greater onus on those producing medical devices. This article takes a look at the major changes the new laws will bring and how they will affect manufacturers. The law at European Union level for medical devices (MDs) is contained in three directives. However, in 2012 the European Commission published its proposals for two new regulations – one on MDs and the other on in vitro medical devices (IVMDs). EU Parliament has now voted in favour of the regulations, which are expected to be in force by 2017. The aims of the regulations are to: increase transparency for manufacturers, notified bodies and national authorities; restore public confidence in light of recent defective devices; and harmonise the law across the EU (they will be directly applicable throughout member states). To ensure compliance with the more onerous obligations and broader scope, companies in the device sector will need to consider a timetable for implementing the changes.
Major changes under the regulations include: Regulated devices will cover more products, including non-corrective contact lenses; aesthetic implants; software used in devices; and possibly certain standalone software. The Commission will have the final say as to whether a product is classified as a MD/IVMD but by regulating more devices it is hoped fewer damaging incidents (eg. the PIP implant scandal) will occur, and more users will be protected from health concerns from incorrectly manufactured/used devices. Greater clarity on how devices are classified, and how powers of notified bodies vary between member states. IVMDs will be classified dependent on their risk, and devices currently on the market may be reclassified if necessary. Distance selling will be covered, therefore sales made online will also need to comply with the regulations. Previously certain products could be advertised online with a pre-conformity assessment. A more extensive investigation will be necessary to obtain a CE mark. For medium to high or high risk devices, clinical and safety data will be required and publically available. Higher requirements for pre and post-market assessments of devices will exist. Extensive clinical trials will have been conducted and the data will be publicly available before sale. A creation of special notified bodies in charge of conformity assessment for higher risk devices. They will be designated by the EMA and will consist of clinical experts and product specialists.
Notified bodies will be more vigorously regulated, but will be able to perform unannounced factory audits and sample data during inspections. They may conduct tests on devices at any time and can demand more documentation before making an assessment. There will be clearer rights and responsibilities for manufacturers, authorised representatives, importers and distributors. Each will require a suitably qualified person (either through formal qualifications or professional expertise) to ensure compliance with batch conformity, reporting and technical document declarations. Every non-custom-made device must be labelled with a unique device identifier so the supplier can be traced and devices can be recalled if necessary. Devices will be relabelled into two categories, single-use and reusable. Companies will not be able to label reusable devices as singleuse to avoid liability if they are reused (and the Commission will state which devices are not reusable). Businesses who previously did not deal in devices may do under the new laws. The more demanding process of device approval and the obligation to disclose data seeks to restore public confidence, but will also increase time and cost to the manufacturer. Companies should implement the necessary systems for compliance as soon as practicable so that any unforeseen delays/issues can be remedied before the regulations become enforceable.
NOVEMBER - DECEMBER 2014 / MPN /7
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DIGITAL SPY APPY TALKING
INNOVATION
This issue the team at IDC chooses its favourite apps. My measures: A handy app for annotating photos with dimensions and text. SketchBookX: A lightweight and easy to use sketching app. Force Effect Motion: A mechanism design app, allowing designs to be quickly iterated and motion simulated (also has a sister app call Force Effect that allows force analysis of static structures). Endomondo: Clever personal trainer app that tracks workouts by GPS for activities such as cycling and running with details of calories burnt, speed, distance, altitude etc. Instant Heart rate from Azumio: An on-the-go heart monitor which uses mobile phone lighting and is handy for workouts. IFTTT If This Then That: A tool that allows you to schedule tasks on your phone. For example, if I take a photo, then upload it to Flickr. TubeBox: Enables you to download and store YouTube videos for viewing offline later. PicScanner: An app which allows you to scan multiple images (four at a time) using the camera on your phone. Sync (previously Bittorrent Sync): This is useful for sharing large files and synching phones. Any.Do: A great task organiser, very clear with minimalistic design. SoundCloud: A handy app to stream music from the internet.
NEWS SPY Gerresheimer opened a new development centre for medical plastic systems in Dongguan City, China. The company has three of these centres in Germany, the US and now China. “Our development centres are important USPs that allow us to offer our customers crucial added value. The new centre in China ensures that we can optimally meet the growing demand in the Asian market. In future, we will have development operations in addition to local production operations and we’ll be collaborating closely with our customers in China,” explained
Andreas Schütte, the Gerresheimer management board member with responsibility for Plastics & Devices. Gerresheimer has been manufacturing manufacturing drug delivery devices such as inhalers and lancets for diabetes sufferers, and infusion products, at its Dongguan City production facility since 2006.
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Healthcanal.com has reported on a novel bi-directional cannula that prevents severe complications following cardiac surgery. The device is the brainchild of Mr Randall Moshinksy, a health cardiothoracic surgeon from Monash, Australia. Moshinsky, who worked with two other inventors on the project – Mr James McMillan, head of perfusion services and cardiac anaesthetist Dr Elli Tutungi – has patented the device in the US that is claimed will enable safer cardiopulmonary bypass procedures and extra corporeal membrane oxygenation (ECMO) support of the circulation and respiration. “Peripheral cannulation for cardiopulmonary bypass is commonly performed via the femoral artery in patients needing temporary life support for heart or lung failure in the intensive care unit (ECMO) and during certain complex cardiac surgical procedures,” Moshinsky told Healthcanal.com. “One of the potential complications of femoral cannulation for cardiopulmonary bypass is leg ischaemia, or lack of oxygen, due to inadequate flow of blood to the limb below the point of insertion of the cannula. ”This can result in severe complications including compartment syndromes and sometimes require a below knee amputation. “The current techniques to prevent leg ischaemia with femoral cannulation are complex and therefore have not been widely adopted,” he added. Moshinsky and his team have entered a strategic alliance with the Italianbased Sorin Group for the development and commercialisation of the device flowing successful pre-clinical trials.
SECTOR SPY
www.researchmarkets.com
Medical polymer TRENDS AND FORECAST
Research and Markets has released a new report - Medical Polymers Market for Devices, Equipment, Packaging and Other Applications - Global Industry Analysis, Size, Share, Growth, Trends and Forecast, 2014 – 2020. The report covers the way in which polymers are becoming more suitable for medical device applications due to lesser weight, better biocompatibility and lower cost. They are also used in various types of medical packaging. It highlights how the onus of responsibility has been transferred onto component and device manufacturers by the Food & Drug Administration (FDA). This has helped material suppliers produce extensive grades of medical polymers for numerous purposes. Commodity resins such as PE, PP, PVC, PS and PET account for majority of the market share. At the same time, demand for materials such as nylon, polycarbonate (PC)
and acrylonitrile butadiene styrene (ABS) is expected to increase. Rising demand for medical devices, increasing preference for home healthcare treatment and growth in aging population are some of the key factors likely to boost demand for medical polymers. Additionally, rising usage of disposable medical devices is expected to augment demand for medical polymers. Over the past few years, polymers have been increasingly substituting materials such as metals in packaging of medical devices, equipment and pharmaceuticals owing to their biocompatibility and lightness in weight.
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NEWS
MOVING
Flexible friend – ELASTIC SENSORS CREATED
R
esearch has identified a new type of sensor that can monitor body movements and could help revolutionise healthcare. Although body motion sensors already exist in different forms, they have not been widely used due to their complexity and cost of production. Now researchers from the University of Surrey and Trinity College Dublin have for the first time treated common elastic bands with graphene, to create a flexible sensor that is sensitive enough for medical use and can be made cheaply. Once treated, the rubber bands remain highly pliable. By fusing this material with graphene - which imparts an
electromechanical response on movement – the team discovered that the material can be used as a sensor to measure a patient’s breathing, heart rate or movement, alerting doctors to any irregularities. “Until now, no such sensor has been produced that meets needs and that can be easily made. It sounds like a simple concept, but our graphene-infused rubber bands could really help to revolutionise remote healthcare,” said Dr Alan Dalton from the University of Surrey. Professor Jonathan Coleman from Trinity College, Dublin commented, “This stretchy material senses motion such as breathing, pulse and joint movement and could be used to create lightweight sensor suits for vulnerable patients such as premature babies, making it possible to remotely monitor their subtle movements and alert a doctor to any worrying behaviours. “These sensors are extraordinarily cheap compared to existing technologies. Each device would probably cost pennies instead of pounds, making it ideal technology for use in developing countries where there are not enough medically trained staff to effectively monitor and treat patients quickly.”
SOCIAL SPY TWITTER WATCH
MPN’s top Twitter picks @PSITestingLabs An independent testing lab We liked . . . Extensive testing can safeguard your company from product recalls
My top tweets The entire RPC workforce has selected its favourite tweets for this months’ MPN Pledge to #recycle more #plastic #packaging because this is what we can do with it! http://bit.ly/1lGqv9d #pledge4plastics @pledge4plastics
@Phillips-Medisize Outsource provider of design and manufacturing services to the medical industry We liked . . . Phillips-Medisize is excited to celebrate 50 years of business operations
RPC Group is a finalist for the ‘Packaging Company of the Year’ award at the @packnews #UKPackagingAwards
@IsisInnovation The University of Oxford’s technology transfer company We liked . . . A “stellar year” for @IsisInnovation, named Technology Transfer Unit of the Year at the GUV awards last night. Hooray
RPC can keep your products in the best of #health http://www.rpcgroup.com/lifestyle/healthcare.php …
Unique oxygen barrier protection: from RPC Superfos. Watch our video here: http://youtu.be/tmfjKysdCwo
2 months to go until @SalonEmballage in Paris! Come and visit us to see our extensive range of #packaging #EMB2014
story...
TALKING POINT Christopher Turmel is the new director of quality at Compounding Solutions. In his role Turmel will oversee the entire quality management system for the company, as well as the regulatory information for the company’s products. Turmel is an analytical chemist with 12 years of experience in the medical biotechnology industry and greater than 25 years of experiences in materials R&D, process engineering, and biotechnology production. What attracted you to your new role? The opportunity to work with a dynamic group of forward thinkers within a small company that are planning on improving its materials and processes to meet ever more stringent customer requirements. As a previous customer of plastics manufacturers, in multiple different roles, I took this opportunity to learn and contribute to plastics manufacturing improvements. During my 25 years of experiences in materials R&D, process engineering, and biotechnology production and R&D projects, I had significant experiences complying with FDA, USDA, and US DOD Quality Systems and Regulations. This new role utilises all those skills I developed in those past roles. What areas do you plan to focus on? Taking our well-developed ISO 9001:2008 certified quality management system and raising the bar over the next 2 to 3 years to ISO 13485, while simultaneously improving the preventative action process internally to reduce or eliminate corrective action incidents. Also, we plan on creating medical polymer product lines that have USP Class VI or ISO 10993 certifications, and are REACH and RoHS compliant. What’s the company’s USP? Our USP is the very high quality of our medical compounds. The company’s major products and efforts create a custom product capability that satisfies challenging customer requirements. Where do you see the business in five years’ time? Continued double digit growth, with increasingly complex materials and processing capabilities.
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NEWS PROFILE
In August, DSM was recognised with the 2014 North America Frost & Sullivan award for growth excellence leadership for medical device coatings. Dr Hinke Malda, director of medical coatings, DSM Biomedical, explains what this award means for the company
In with a
WIN
Customer commitment and partnerships The award means a great deal for DSM because it supports our mission to become the preferred partner for medical device companies. By partnering with a medical device company, rather than simply being a supplier, we offer a greater level of service that touches a device from R&D through manufacturing and coating application. We are able to truly listen to the device maker’s requirements from the first conversation until the device is brought to market. Our knowledge of the medical industry and expertise in medical coatings enables us to offer technology and services with unique value. While medical device companies are the experts in their devices, they are generally less knowledgeable about the coating system and how it should be used or applied. In collaborating with a company like DSM, a synergy is created wherein both companies share the experience and can build upon each other’s expertise. We go through an extensive vetting process with new business leads and make sure that at DSM, we can fully envision what the customer wants out of our proposed partnership.
Leveraging healthcare market needs DSM works with customers across many different disciplines. We believe that a strong partnership exists where both teams can really work together, understanding each other’s needs and expertise. Additionally, being recognised by Frost & Sullivan proves the success of leveraging DSM’s medical coatings competencies to answer healthcare market needs. The multinational DSM consisting of multiple business divisions is able to leverage its combined technologies and competences to address customer needs. For example, although the medical device coatings group and the coating resins group are separate divisions within DSM, both groups learn from each other. We share research and development results on coating formulations, application processes and other chemistry findings. This internal crosscollaboration helps DSM make a more significant impact for partners in various industries and marketplaces.
Surpassing the competition Frost & Sullivan’s award states that although the space is marked by strong competition, DSM has been able to maintain steady top-line growth in just a short time span of seven years. At DSM, this is attributed to the fact that we have a very dedicated team where every employee is passionate and extremely devoted to his or her job. Making people’s lives brighter is part of our DSM brand promise and is a strong motivating factor for us. Each employee really believes in the strength of our technology and how it can improve patients’ lives throughout the world.
The future of DSM Ultimately, this recognition from Frost & Sullivan is a great accomplishment for us. Internally, we know that we are doing great things, and being recognised by an external party validates our efforts. As part of our business strategy, we continue to stay up-to-date on new market trends and unmet needs through market surveillance, regular customer satisfaction questionnaires and direct interactions with the surgeons, patients and regulatory agencies. It’s also our goal to continue to strive for excellence in the medical device coatings market by maintaining a tight focus on research and innovation as well as continuing to build close relationships with industry peers.
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NEWS PROFILE
Material
WORLD 3
D printing has made its transition from simply a trend to something that is here to stay. Until recently, 3D printing was easily dismissed because it wasn’t relevant to individuals or the vast majority of companies. The ability to print something immediately — and in your home or office — was just a pipe dream. Even more, the idea of printing something for medical use was unheard of. Now, that’s all changed. One development in particular has helped solidify 3D printing’s position as a game changer. A material has been specifically designed to improve functionality of personal, extrusion-based printers. Eastman Chemical Company, a specialty chemical company, and Helian Polymers, a key player in the masterbatch and biopolymer industry and brand owner of colorFabb, have teamed up to launch colorFabb XT-Copolyester made with Eastman Amphora 3D polymer.
EASTMAN CHEMICAL COMPANY HAS TEAMED UP WITH HELIAN POLYMERS TO CREATE A NEW MATERIAL WHICH IT SAYS WILL BRING CHANGES TO THE 3D PRINTING INDUSTRY
ColorFabb XT-Copolyester focuses on functionality and features strength, workability, processing, aesthetics and low odour for 3Dprinted products. The low-odour, styrene-free polymer is suited for the 3D market with benefits in air quality (it generates fewer ultra-fine particulates than ABS), dimensional stability – including temperature resistance to create functional parts, great layer bonding for reliable processing and great part finish, and chemical resistance for last good looks and performance – and regulatory compliance Transforming 3D printing The new material, says Eastman, is positioned to transform the 3D printing industry by bringing functionality to desktop printing. It has been designed to empower consumers to create strong, functional 3D products, while ensuring improved air quality and dimensional stability with a material that allows it to meet certain FDA requirements for use in food contact applications. Through its functionality, colorFabb XT-Copolyester could change prototyping. Printers can now 3D print and test with materials similar to their end product, expediting the design process. According to Eastman, this expands the market for prototyping applications substantially, opening it up beyond top-tier companies that can afford the expensive machinery.
<< Material gains: Eastman says that the launch of this material designed to address the challenges of desktop 3D printing will prompt similar developments >>
Alex Dudal, market development representative at Eastman, explains: “So far, the 3D sector has been limited to big, expensive machines that can work with more difficult materials. Now, we’re seeing a rise in desktop printers entering the market, which require a more workable material than commonly used ABS or PLA. This movement justifies a surge in materials specifically formulated for personal 3D printing. Materials like Eastman Amphora 3D polymer offer more capacity for these personal desktop printers to compete with the much more expensive offerings.” The move to new markets By making 3D printing more accessible, new markets — such as education and medical — can benefit from its capabilities. Educational institutions are already a part of the conversation, as many new desktop printers are going into schools. But with materials specifically created to meet their needs, many more schools eventually can be expected to have desktop printers. The same goes for the medical field. The customisation of these materials makes 3D printing more accessible and allows users to think outside of its currently limited capabilities. Best of all, by providing support for affordable options, these materials will make 3D printing a possibility for health care institutions. Looking to the future This is only the beginning. Eastman says that the launch of this material specifically designed to address the challenges of desktop 3D printing will prompt similar developments for industry-specific and affordable options. The company says that large manufacturers, which have been dominating the 3D printing marketplace, are now going to see even more competition from smaller printers, print shops, and even individuals with single printer capabilities. Prototyping capabilities will expand extensively. Safety concerns, especially in regard to the medical field, will be addressed and 3D printing will only continue to grow. “Based on the amount of people taking interest in 3D printing, from those interested in it for personal use to medical to educational, there’s bound to be more development — and quickly. The next big step for 3D printing is coming soon,” Dudal says. “New, better performing materials will push the 3D printing industry beyond its current exclusivity. Eventually, the vast majority of people could be using 3D printers in some capacity, especially those who touch product design, or who are in the educational or medical fields.” NOVEMBER - DECEMBER 2014 / MPN /13
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SPEECH THERAPY
www.cimedtech.com
<< Group chat: Joe Hage, leader of LinkedIn’s Medical Devices Group advises in participating in group conversations that demonstrate your subject matter expertise, as one way of boosting your profile >>
Social etiquette Is it worth trying to market medical devices on LinkedIn? Lu Rahman speaks to Joe Hage, who runs the Medical Devices Group on LinkedIn. With a quarter of a million members, Hage shares dos and don’ts on using this popular platform for marketing your business
O
ne of my LinkedIn connections recently posted a link to his company site. He didn’t say anything about his business. It was just a link and because I know him, I clicked and was directed to his homepage. When I arrived, I saw nothing extraordinary, just the usual info, so I left. It made me wonder if he was wasting his time trying to use LinkedIn to promote his company. I spoke to Joe Hage, Medical Plastics News reader and head of the Medical Devices Group on LinkedIn. Hage has amassed a quarter-million members in the group, making it, he says, the largest medical device community in the world. MPN: With the time you spend on LinkedIn, you must believe it’s a worthwhile destination for medical device companies. Joe Hage: If it’s used properly, yes. The homepage link you looked at was not a worthwhile effort. MPN: It does seem he could have done more. Do you have examples of ‘LinkedIn Done Right?’ JH: Many. Some are public and some are behind the scenes. MPN: By ‘behind the scenes’ do you mean using search functions to find your prospects? JH: That’s one tactic, but how do you feel when a perfect stranger emails you about his product or service. Often it’s spam. Going through a common connection helps but sometimes this is an imposition to your connection and to the ultimate recipient. My favourite example of ‘behind the scenes’ is positive reinforcement. Everyone who creates content – whether it’s a group discussion, comment, or blog post – craves feedback. My view is that we should give it! A ‘like’ is a good place to start and taking the time to comment is better. You can do it publicly or privately. When I send a private comment to a Medical Devices Group member, the response is unanimously positive, ranging from gratitude to a request for a live conversation. It’s the beginning of the getting-toknow-you process. MPN: Any other examples? JH: In general, just do your homework. Spend time on their page. The more they have written about themselves, the more information you have as a jumping-off point.
MPN: And what are the public examples of ‘LinkedIn Done Right?’ JH: First, know what you want your profile visitor to think when s/he visits. Are you positioning yourself as the right person for the opportunity you want? Use visuals wherever possible – short videos are best. If you’re selling catheters, convince me you’re knowledgeable about the whole category – not just your product line. Second, participate in group conversations that demonstrate your subject matter expertise. This is where the Medical Devices Group excels because I personally decide which topics are worthy of the busy medical device executives’ time. I’ll give you a direct quote from linkd.in/new-business: “When I first joined the group I wasn’t very active… Now that I am, the viewers of my blog have doubled, I gained three new consulting clients, I have increased my network connections from 700 to 1,000+, and I have two new public speaking engagements planned for this year. I have also helped a few people find a job. There is a direct correlation between what you give and what you get.” Third, online conversations begin a relationship – you can cement them in person. The Medical Devices Group is hosting its third annual meeting (the 10x Medical Device Conference). Another direct quote, “As a smaller medical device manufacturer, I can absolutely say 10x was more than worth the cost of admission. We are currently working with two companies I met at 10x.” And fourth, webinars and whitepapers. If you have high-value content, ask group managers to promote it for you. This week we hosted the ‘Selling Medical Devices in This Difficult Healthcare Environment’ webinar featuring group member Mike Sperduti. To date, 631 members accessed it. These are impressive statements and it really does prove that there is a direct correlation between what you give and what you get. I would also say that LinkedIn users smell self-promotion a mile away don’t do it. From a marketing perspective, if you consider what someone on LinkedIn is looking for in an article or discussion, it’s credible insights from subject matter experts. In other words, if you don’t have something valuable to add, platforms like LinkedIn can’t help you. But if you do, LinkedIn is absolutely worth the time for marketing medical devices on LinkedIn. NOVEMBER - DECEMBER 2014 / MPN /15
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SPEECH THERAPY
VOCAL Exercise George Paleos, Vice President, Global Industrial Marketing Medical, Consumer Products & Optical Data Storage Business Unit Polycarbonates, Bayer MaterialScience Q: Who are you and what do you do? George Paleos based in Pittsburgh, USA, the head of global industrial marketing within the polycarbonates business unit of Bayer MaterialScience for the medical, consumer products and optical data storage industries. Q: How would you sum up your company? With 2013 sales of EUR 11.2 billion, Bayer MaterialScience is among the world’s largest polymer companies. Business activities are focused on the manufacture of high-tech polymer materials and the development of innovative solutions for products used in many areas of daily life. The main segments served are the automotive, electrical and electronics, construction, medical and the sports and leisure industries. At the end of 2013, Bayer MaterialScience had 30 production sites and employed approximately 14,300 people around the globe. Our polycarbonates are used in some of modern medical technology’s essential devices and the development of nextgeneration technologies. We support the healthcare industry by providing advanced technologies and solutions through strong collaboration with leading medical device OEMs.
“Bayer MaterialScience is among the world’s largest polymer companies.”
Q: Business achievement you are most proud of The development and commercialisation of Makrolon Rx1805, the first radiation-sterilisation-stable, lipid-resistant, medicalgrade polycarbonate. The development of this product was the result of addressing a key market need and collaboration with several medical device OEMs. The product adoption and growth over the years in the medical device industry and in particular the IV access segment has been a satisfying commercial success. Where do you predict industry growth will come from in the next 12 months? Surgical devices, diagnostics and emerging markets. Which medical plastic device do you wish you had invented and why? Cardiopulmonary bypass oxygenator, also commonly known as blood oxygenator. This device is used to exchange gases, oxygenation of and carbon dioxide removal from blood during a patient’s open-heart surgery. Although this life-saving device was invented many years ago and has been declining in use due to technological advances of less invasive angioplasty procedures, it has withstood the test of time and is still used in hundreds of thousands of surgeries every year for better outcome in patients with more severe coronary disease.
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COVER STORY
P U R E G O L D 18/ MPN / NOVEMBER - DECEMBER 2014
LR: Phillips-Medisize is celebrating 50 years success in the sector. What has contributed to this success and what sets you apart as a company? MJ: This is a big year and a significant milestone for the company as we celebrate our 50th year of continuous operation. Our success has been driven by the execution of a classic principle...building partnerships with our customers based on quality, service and innovation as well as, a focused investment centred around people, processes and facilities which we think sets us apart from our competitors
HITTING HALF A CENTURY AS A BUSINESS IS A SIGNIFICANT ACHIEVEMENT. A KEY PLAYER IN THE MEDICAL DEVICE INDUSTRY, PHILIPSMEDISIZE IS CELEBRATING 50 YEARS IN THE SECTOR. LU RAHMAN SPOKE TO MATT JENNINGS, CEO, TO FIND OUT WHAT’S BEHIND THE COMPANY’S SUCCESS AND WHAT HE SEES IN STORE FOR THE NEXT FIFTY YEARS
LR: In your opinion, what has made you a perfect outsourcing partner? MJ: The ability to understand the nexus of part design, manufacturing requirements and automation capabilities. We have developed a demonstrated ability to integrate advanced moulding, automated assembly, and quality control systems into the product design and the manufacturing process, which often delivers innovative, high-quality, cost-effective solutions for our customers. We partner closely with our customers to make their innovative designs come to market with the highest regard for safety, scalability and protecting their intellectual property and designs. We believe that the integrity of our people and processes helps bring our clients’ innovation, ideas, and products to market while adding to our expertise in the areas I’ve already mentioned.
LR: Is there one single factor has contributed to the company’s longstanding success? MJ: Our people. The heart and soul of Phillips-Medisize is our people. It is their expertise and knowledge that allow us to solve our customers’ challenges. We are willing to invest and grow with our customers and with the industry. We continue to expand our to quality and technical expertise within the drug delivery space to stay current with changing requirements and properly staffed with the growing demand. We are actively seeking to add to our organization people who are committed to quality, have a passion for excellence and want to be part of building the best products and a better company. It is truly our peoples commitment that has allowed us to have the long-standing success over the past 50 years.
LR: Can you share some of the highlights of those 50 years with the readers? MJ: 50 years ago the company began as the vision of its founders in northern Wisconsin. Through the years, the company expanded into the medical device space. With the expansion into medical device, we’ve become a true leader in drug delivery, working with the top biopharmaceutical companies in the world, manufacturing auto injectors, pen devices and diagnostics across a variety of indications for global markets. In 2010 the founder of the company sold his controlling interest to Kohlberg & Company, a New York based equity capital firm, which was able to provide very needed growth capital. Shortly thereafter the company acquired Medisize which expanded its global reach. This past June, the company was sold to a much larger equity capital firm, Golden Gate Capital, again to support its ability to continue to grow. Since the founder sold Phillips Plastics, the company has more than doubled in size from about $270 million in annual revenue to just shy of $600 million. Today, Phillips-Medisize is truly global company with manufacturing and design centres in Europe, the Americas and on the European continents.
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The company has 14 locations and employs over 3400 people. So, rather than just reflect on the past, we honour it by celebrating where we were and by looking forward to a bright future.
LR: Describe 2014 for the company – have you achieved everything you set to do at the start of the year? MJ: To-date, 2014 has been our best year ever and we expect that trend to continue. We are meeting or exceeding all of our goals and are excited about what the future has in store for Phillips-Medisize. LR: Which achievements are you particularly proud of this year? MJ: In April, we commenced full-scale production of the first drugdelivery injector pen from our new Suzhou, China facility and we will be opening a Design Development Centre there later this year. We have also completed a significant plant expansions at our facilities in Finland, as well as, our Metal Injection Molding (MIM) facility and plan another expansion to the MIM facility next year. This is in addition to expanding our New Richmond facility. These opportunities have all been made possible by new business awards from our customer base In May we achieved the president’s “E” Award for exports which is the highest recognition any US entity may receive for making a significant contribution to the expansion of US exports.
LR: Tell us about the work Phillips-Medisize is currently carrying out MJ: Phillips-Medisize currently focuses on three business segments in the medical space; diagnostic devices, drug delivery systems and single-use medical devices. We leverage our expertise in these segments to help our customers design and manufacture products that will improve the standard of care in the respective markets they serve in a more cost effective manner. We do this through innovative design and manufacturing for a variety of products that include insulin pumps, pens and autoinjectors for both branded and generic products. With the advent of new therapeutics and biosimilars we are excited about new customers and opportunities to expand our business, and our customers success, into greater number of patients who are in need.
LR: With the experience you have in the medical device sector, where do you see the innovation currently coming from? We think innovation is a collaborative process and a requirement of all those who work in the design, development and manufacturing disciplines. We work together with our customers to help them design products that meet their customers’ needs in a more cost effective manner. We work hard in defining the supply chain for our customers’ products employing creative sourcing strategies for critical componentry and raw materials in a time sensitive environment. We use our engineering skills and manufacturing know-how to design the most effective manufacturing processes with quality and cost as top of our priorities. Innovation is in our view, 10% inspiration and 90% perspiration.
LR: What are the current challenges for the medical device market at the moment? What would you like to see done about them? MJ: The dual challenges of expanding access for patients while health care payers seek to define value and lower overall costs will continue to be a challenge. These dual goals will drive health care companies around the world to be more efficient. Critical to this is process innovation in product design and manufacturing to assure lifesaving products get to market at cost structures that will work for our customers and their customers and payers. I think this will be an iterative process and all parties will need to cooperate to make sure that the quality of care is not inhibited by these economic pressures and that we find a way to drive toward a continuous improvement culture. It will be interesting to see how Point of Care diagnostics and self-treatment reshapes the delivery of care. We are working with our customers to make this happen. LR: Where do you see the opportunities in the industry?
<< Forward thinking: Matt Jennings, Phillips-Medisize says the company is meeting or exceeding its goals and is excited about what the future has in store >>
MJ: We believe that the greatest opportunity is in the pre-production process. Outsourced design engineering resources become critical in an environment where cost is a paramount concern for our customers as, our customers just will not be able to staff for all their needs. Therefore they will need competent outsourced design engineering to complement their need for outsourced manufacturing, while doing so quickly and with full regulatory compliance. We believe our approach of working with customers during the early design phases of projects affords that opportunity by planning the integration of sophisticated moulding, automated assembly and appropriate quality systems into the product and manufacturing process. By having our design engineers engage right from the start of that process, we can make the process much more efficient which will lead to better outcomes and often increased speed to market. From there, our program managers work closely with our customers to ensure a fully transparent process and partnership that speeds product to market.
LR: What does the next 50 years have in store for the company? Any predictions? MJ: Looking ahead the next 50 years is hard, but one thing is for certain, Phillips-Medisize will continue to grow. We will continue to focus on expanding the capabilities of our people, process and facilities to meet the changing needs of our customers. In addition, we will do additional acquisitions that are consistent with our strategy to expand our design and manufacturing capabilities to support our customers’ growth. Targeting companies with a common vision and culture is critical to enabling smooth integration of our proprietary approaches. Done successfully, we create both a unique and differentiated product development and outsource manufacturing service solution to our customers. As opportunities present themselves we will evaluate them based on the value they create for our customers, investors and also our people. NOVEMBER - DECEMBER 2014 / MPN /19
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DESIGNED FOR LIFE
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Personal service << Head start: Any discussion on 3D printing in the medical world wouldn’t be complete without highlighting how ideal the technology is for craniomaxillofacial procedures, says Daniel Daryaie >>
Daniel Daryaie, Materialise, discusses the ‘extreme to the mainstream’ and the 3D printing revolution in personalised healthcare
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early every day we hear of another exciting case where 3D printing played a significant role in a patient’s treatment. Whether it’s a custom implant, drill or cutting guide, or an anatomical model; 3D printing is revolutionising the medical landscape on many levels.
The value of 3D printing was recognised early in the hearing aid market resulting in over 10 million 3D printed hearing aids in circulation worldwide (according to Phil Reeves, Econoloyst). The size of hearing aids, material property requirements, cost of the traditional manufacturing methods and clear benefits to patients when they are created in a patient-specific manner made them ideal for 3D printing. The question today is what other procedures or devices could benefit from the technology, how to address the regulatory concerns and how to get reimbursed. Materialise, a Belgian-based company began in 1990 as a specialist in additive manufacturing and has grown into a key player for 3D printing, software for medical image processing and digital CAD software. In addition to its own 3D-printed medical devices it brings to the market its Mimics Innovation Suite software package that allows companies and hospitals to convert patient-specific medical image data (CT and MRI) into 3D models for anatomical quantification, FEA simulations, medical device size selection, custom implant design, virtual surgical planning, and, of course 3D Printing. Materialise’s customers are the heroes of advanced medical applications of 3D printing and are innovating ways to improve clinical outcomes by pushing the limits of the technology. Scott Hollister and Glenn Green from the University of Michigan made headlines with their bioresorbable trachea splint which has already saved several children with lifethreatening tracheobronchomalacia. By combining the ability to design custom devices based on each patient’s unique anatomy with the ease of 3D printing and the latest advancements in materials; they hit the trifecta for maximising the technology’s capabilities in an entirely new way. Another area where 3D printing is invaluable is the planning of complex surgeries of congenital heart disease. Kosair Children’s Hospital was presented with a case of a 14 month old with four congenital heart defects. The complexity of the defects made planning the surgery difficult without a physical model and 3D visualisation. Materialise’s software was used to accurately represent the child’s cardiovascular anatomy, scale it for better visualisation and section the model into three
pieces so that internal structures could be analysed as well. Thanks to the 3D-printed model, the surgeons planned a simplified approach to repairing the defects. Not only was the procedure effective, it also minimised the post-operative recovery. Any discussion on the value of 3D printing in the medical world wouldn’t be complete without highlighting how ideal the technology is for craniomaxillofacial procedures. Head and neck surgeries not only require removing and repairing anatomy but also symmetry and aesthetically pleasing results. Companies like OBL are using the Mimics Innovation Suite to mirror a patient’s healthy anatomy as a reference for repairing their defect. By 3D printing in porous titanium, resulting implants are light, strong and perfectly match the patient’s anatomy. In 2013, medical implant manufacturer Oxford Performance Materials (OPM) became the only company to receive FDA clearance to manufacture 3D-printed, patient-specific polymeric implants for its cranial implant line. Its OsteoFab Patient-Specific Facial Devices (OPSFD) are designed with Materialise’s 510(k) cleared software, which was beneficial for OPMs regulatory submissions as scrutiny of software in custom device design is increasing. With concerns regarding insurance and reimbursement, many surgeons are still hesitant to use 3D-printed medical devices according to data collected by the research and consulting firm GlobalData. Until insurance companies incorporate these cutting-edge methods into their reimbursement systems, the innovative solutions for hopeless cases, improved clinical outcomes and even reduced overall treatment costs that 3D Printing can offer may be artificially limited. Fortunately, the doctors at Boston’s Children’s Hospital haven’t been deterred and used a soft, plastic, 3D-printed replica of an infant’s brain which included the blood vessels in a contrast color to practice a hemispherectomy, an extremely complex and rare procedure that involves disabling one cerebral hemisphere of the brain from the other. Thanks to the surgeons’ ability to plan and practice on the 3D-printed model, surgery was successful and the child is now seizure-free. It’s exciting to see the evolution of 3D printing as the technology is reaching new levels and redefining what’s possible. As we move from 3D printing training models, to implantable devices and eventually organs from a patient’s own biomaterials; a ‘better and healthier world’ is clearly on the horizon. NOVEMBER - DECEMBER 2014 / MPN /21
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SPOTLIGHT
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Role call The explosive growth of medical plastics worldwide generates technical challenges. The educational resources of SPE can help address these issues. As the new managing director of SPE, Russell Broome tells MPN about his new role and the areas he will be focusing on
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roome will be responsible for carrying out and enhancing the changes and improvements that SPE has initiated in the past two years. His focus will be on the society’s North American operations and in particular on attracting more young plastics professionals to join the society.
My entire career has been focused on the plastics industry and SPE’s role in it.
MPN: What led to your new role at SPE? RB: My entire career has been focused on the plastics industry and SPE’s role in it. During college, I worked at mould-making and custom moulding facilities. Upon graduating, I started out as a design engineer for an OEM, then for many years held sales and marketing positions with compounding companies. Finally, in the two years prior to becoming managing director of SPE, I provided plastics technical and commercial support for another OEM. SPE has been a guiding force for me as far back as my student days when my father brought me to a meeting of the SPE Piedmont-Coastal section in our home state of North Carolina. I owe much of my career success to the knowledge, networking, and leadership experience that I have gained through my involvement in SPE. Increasingly in my 20 years of volunteer service for SPE, I have focused on attracting students and young professionals to the society and making their SPE experience as positive and beneficial as mine was.
MPN: What areas will you focus on? RB: As the new SPE managing director at our headquarters in Bethel, Connecticut, I’ll be focusing on making our operations exceed the expectations of current and prospective customers while becoming more nimble and proactive in a fast-changing industry environment. In addition, I hope to enhance the relationships of SPE with corporate and academic organisations in the plastics industry, as well as with other industry professional and trade associations. These improvements will enable our European-based CEO, Willem De Vos, to focus more on the same opportunities globally. SPE will offer many new products and services in the coming months as we increase brand awareness and customer value while staying true to our core mission of providing peer-reviewed technical information and networking for plastics professionals.
<< Looking ahead: Russell Broome, the SPE will offer many new products and services in the coming months as it increase brand awareness >> I hope to enhance the relationships of SPE with corporate and academic organizations
MPN: How important are medical plastics for SPE? RB: Medical plastics play an increasingly important role in SPE activities. We now have two divisions devoted to medical technology—the Medical Plastics Division in North America and the European Medical Polymers Division in Europe. Both divisions regularly organise multi-presentation sessions as part of our major technical conferences, such as ANTEC in North America and EUROTEC in Europe. In China last year, SPE presented its first educational programme in that country, one of them being a twoday topical conference on medical plastics.
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TRAINING
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Home schooling Rebecca Murphy, GW Plastics, explains why in-house training is crucial to the advancement of manufacturing Manufacturing companies often overlook the importance of offering training programmes, both for people inside and outside of their organisation. Between gaining new skills and nurturing existing abilities, providing ways to improve and empower your workforce and community is crucial to the success of your business and the industry. By offering unique opportunities to gain a range of skills in world-class manufacturing environments, employers are rapidly strengthening their communities and ensuring that their teams are as educated as possible. There are three main reasons why manufacturing companies should offer inhouse training programs and internships: Boost the local economy and generate more manufacturing jobs Many companies create training opportunities such as internships with the hope of spreading their passion for manufacturing throughout the community and providing the local youth with an exciting reason to stay in the area. By demonstrating that manufacturing offers attractive careers both for today’s youth and experienced workforce, more jobs in this field are starting to be generated locally and nationally. This past summer, GW Plastics hired five summer interns and we are already seeing a positive rate of return, as one intern has returned to work part-time. I am proof that this route truly works. If it had not been for an internship at a manufacturing company in southern Vermont, I would not have sought out other manufacturing opportunities in Vermont and ultimately chosen GW Plastics. Due to the current state of our economy, students are always searching for opportunities to grow their skills, so if companies give them the chance to mature professionally, they will take it.
Ensure that students and employees are adequately trained Internships and apprenticeships also ensure that students intending on having careers in manufacturing are adequately trained. Many colleges simply are not doing enough to create proficient technicians and moulders, so it is up to outside programmes and businesses to make sure that the students graduating from these schools will excel in this field. For many manufacturing companies, the customer base includes Fortune 500 companies and global OEMs, so it is imperative that the employees are the best they can be in order to successfully mould safety-critical parts. Manufacturing companies need to provide students with a solid learning experience that will shape the way they think in order to ultimately create capable technicians and engineers. One of the ways manufacturers can accomplish this is through apprenticeship programmes. GW Plastics currently offers informal apprenticeships in all of our manufacturing locations, as well as a formal two-year apprenticeship in our Tool Division in Royalton, Vermont. In the world of manufacturing, you can either recruit welltrained technicians or you can ‘grow your own’. It is important to recognize that attending a four-year liberal arts college is not practical for everyone, so offering apprenticeships is an ideal way to help students grow in a field they might not have originally considered. These internal apprenticeships create highly-qualified employees and we have hired several graduates from our apprenticeships full-time. Company-wide standardisation The benefits of offering internal training opportunities go far beyond increasing jobs. For companies who prioritise quality, training programmes are the best way to ensure standardisation and ultimately guarantee high-quality parts. New employees come with various skill sets and knowledge-bases, making it difficult to regulate the moulding
processes. Even if they are highly-trained technicians, everyone has a different way of doing their jobs, so offering a certification course helps to systemise the approach. GW Plastics’ devotion to quality and consistency required that we create a way to regiment our manufacturing, so we partnered with RJG to provide in-house manufacturing courses. These classes range from one-day introductory courses to ten day Master Moulder certifications, some of which are open to our customers as well as our employees. In this industry, it is crucial for employees to follow the guidelines created in order to mold high-quality parts, as well as for customers to understand what exactly the process entails. Ensuring that employees are as knowledgeable as possible, leading to robust processes and the manufacturing of first-class parts, is critical in the medical plastics sector where a low-quality part can injure a patient. The benefits of offering training programs are limitless, and we encourage other companies to join us in our mission of advancing both the manufacturing world and our local communities.
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MICRO MOULDING
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Small talk Aleksandra Jones talks to Aaron Johnson, VP marketing & customer strategy, Accumold to gain a first-hand view of the micro moulder What are the specific constraints of micro moulding that you don’t experience in the case of traditional moulding?
What are the conditions like in which the parts are produced, packaged and inspected?
It might be easy to think that micro moulding is simply large-scale moulding made smaller. This is simply not the case. There are a lot more variables at play the smaller you go and when you’re talking about very small features, very thin wall sections, the material you use starts to have a profound effect on performance and gating. Efficiencies start coming to play. You have to make sure that your part size and your runner system are correct in terms of efficiency. There’s an art form to the tool building and processing that goes beyond the data sheets and traditional approach to moulding. It becomes a highly experiential process. You can’t simply buy a press one day and suddenly start micro moulding. A lot of people who have tried this have found out that there is more to it than meets the eye. A lot of it has to do with the subtleties of tool building and processing side to get the part with the features and tolerances that are often requested.
I will start with metrology, which is a big part of the whole process. If you’re asked to produce a part that only has features of a few microns, you have to be able to see it, measure it and repeat the process. There is complexity in figuring out how to deal with part handling for measurement. You have to remember that if you’re looking for ±3 micron in tolerance, your measurement can’t have an error margin larger than that. That is definitely a big learning curve.
Another aspect of it is what you actually call micro moulding. If the part is tiny, that’s just one thing, but if you’re talking about something that’s tiny but also has a few microns in tolerances or feature sizes, then you’re adding a whole new layer of complexity to the equation. So it’s more than just making small parts — there is usually a complexity and sophistication that adds to the constraints. What puts Accumold in the right position to make these parts with very small features and tight tolerances? The biggest advantage for Accumold in terms of micro moulding is that we have been doing it for almost 30 years. This is the area in which the company started. In the mid 1980s electronics really started to take off and parts were starting to shrink — that’s when the company was set up. We have built micro moulding from the ground up; we are pioneers in pushing the limits of plastics — we have been growing the expertise over the last 30 years. As I said, it is a very experiential art form and we have that experience to draw from. We know the tool building and processing side of it and where the constraints and the successes are.
We work in a clean environment, we also have class 8 and class 7 medical cleanrooms, so we can produce high-end microelectronics or medical components. That isn’t necessarily a requirement for micro moulding, but we find that a lot of the time these critical components demand a clean environment. Not all traditional moulders necessarily have that set up. Packaging is another interesting aspect of micro moulding. If you have a part that is only 800 microns long at its longest feature and it needs to be packaged, it can be more difficult than the moulding of the small part itself, because you’re dealing with controlling the part, micro robotics, micro sensors or whatever it is you need to deliver the part the way the customer needs it. We get asked all the time when we show customers these parts: How do you handle these? Handling is definitely another constraint in the complexity of micro moulding. Could you give us an overview of the specific technologies you use? Accumold is an injection moulder. In some ways, there is a traditional element to it: it’s melting plastic material into a cavity, closing the mould around it and having it harden and making the part that the customer asked for. We add to it the layer of the size complexity and the geometries, feature sizes and tight tolerances that push the limits further.
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A lot of people ask for guidelines for micro moulding. It is a very tough question to answer because in some respects we can set some guidelines, but it is very situation-specific. The geometry, the material and some of the features all have a profound effect on how to push the limits of what we’ve done so far. If your part is so demanding, we highly encourage you to start speaking to your micro moulder at the concept stage already, so that you can work through some of the early challenges and maybe save yourself some difficulties of product development. You serve a variety of market sectors. Is there any difference in producing parts for companies from different industries? Generally speaking, Accumold deals with critical components so there is a very technical approach to just about every market sector that we encounter. Accumold is ISO 13485, which means that we have certain processes in place to ensure all the documentation is under control, which is crucial for the medical industry. We put that constraint on all of our operations. Micro optics is an interesting sector: not only are we often dealing with highly-engineered resins, small features and very tight tolerances (in fact, some of our most extreme tolerances are in the optics sector), but in this case we also have to deal with surface finish and material clarity for the particular part to function. Being able to handle the mould design and the processing, so that light can be transmitted through these parts, adds two more layers of complexity for us to deal with in an already complex situation. Can I ask you for some specific examples of parts you have produced for your clients? At least the ones you are allowed to talk about, of course. I could say that right now there is a big trend for medical sensors, transcatheter systems for device deployment, drug delivery or diagnostics. Medical devices are shrinking and becoming more personal, and all the electronics and connectivity means producing more sophisticated, smaller devices. The medical industry is following the consumer electronics market in terms of sophistication — that means more demand for more complex parts, which results in a great drive in micro technologies, such as micro moulding.
When you receive an order, do you usually know what that particular part is going to be used for, is it relevant to you? In most cases we know the general idea and in some cases we know the exact plan, but it isn’t always the case. I would also like to ask you about the production process: the five stages of production. In what ways are these five key stages important for the company? The design for manufacturability is what I referred to before: it starts at the concept phase. We’re dealing with pushing the limits for micro plastics. Most customers don’t just want one part. They want to figure out how to make one part so that they can make whatever quantity their customers demand: thousands or millions down the road. Accumold is also looking at it from the perspective of wanting to make all of the required parts, not just the one. That’s why we want to start with the most robust process from the beginning. We look at the customer’s part design, giving feedback on how successful we think it is. That plays right into the material selection process — they go hand in hand — what material it is, how it’s going to affect the performance. We don’t design, we don’t select materials, but we do offer guidance in helping customers by sharing what we’ve learnt over the years. Tooling project management is all about lead times, getting the product in your hands when you need it. The production process is about getting the product to the customer in, what we call, the manufacture-ready state, so that it’s ready to be used by your automation system or in whatever way you need it — that’s how we want to provide it. The customer service component is about servicing and managing the process from start to finish, throughout the life of the product. NOVEMBER - DECEMBER 2014 / MPN /27
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ADVERTORIAL
THINK CONSISTENCY AND EXPERIENCE, NOT ONLY RESINS
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olyolefins are versatile resins that continue to replace traditional materials used in healthcare applications such as glass, metal and polyvinylchloride (PVC). Polyolefins offer numerous advantages including safety of use and ease of handling, productivity and new design possibilities, which could be more complex and costly to achieve with glass, metal and or PVC. One example is the use of polyolefins to produce parts for insulin injection pens, a highly effective drug delivery system. This rapidly growing drug delivery system offers numerous advantages over the traditional insulin syringes including ease of handling, dosing accuracy and more discrete self-medication. In healthcare applications, selecting the right resin with the desired properties is key, but what about consistency of formulation, continuity of supply and most importantly applicable regulatory requirements? What about the underlying operational procedures addressing and managing consistency and contamination risks? There are numerous considerations when selecting a resin for a healthcare application but it is equally important to identify what type of service package you should expect and how to distinguish one from another. Besides, in order to be effective, a service package must be a living concept that is continuously developed with internal capabilities and is aligned with the external factors e.g. processing, regulatory and application requirements. Resin selection for healthcare applications might seem a costly exercise, but re-validations and re-registrations are more costly and certainly undesired. In a regulatory driven industry, resin selection process is essential although trivial differences may lead to costly re-validations and re-registrations and also undermine safety and regulatory compliance requirements. Polyolefin producers, to ensure long-term formulation consistency and reduce contamination risks, should develop, implement and maintain a series of dedicated operational procedures to address manufacturing and supply chain. The development and implementation of these dedicated operational procedures not only require an organisational commitment and experience, but it also represents a cost factor which needs to be justified when only about 2% of 135 million tons of polyolefins manufactured are used in the healthcare applications annually. One common misconception is that resins used in food and healthcare applications share the same approval requirements, but it is crucial to recognise that food and healthcare applications are different from both safety and regulatory compliance perspectives. Changes in the manufacturing process or resins’ formulation with food-contact approval may be acceptable for food applications but the same change in a resin used in a healthcare application may have far-reaching consequences. 28/ MPN / NOVEMBER - DECEMBER 2014
While it is common practice to change additives or stabilisers in resins used in food applications for cost efficiency purposes, this change does not require a change notification to be issued as long as the resin maintains its food-contact approval status. However the same change in resins used in a healthcare application may require extensive re-validation studies including leachable and extractables, stability and suitability studies which now may have changed as the result of this change. The old adage “time is money” is as true today as it ever has been. Therefore not only selecting resins that meet both European and U.S. Pharmacopoeia requirements can expedite product approval process, but it also can help streamlining the complex validation process during the registration process. Moreover, governmental regulations and pharmacopoeia compliance standards may differ from one geographical region to another, and they become more stringent in their requirements every year. Knowledge of these regulations and the deviations by geographic region or by application type can help avoid possible pitfalls in the application process. LyondellBasell is one of the leading manufacturers of specialty polyolefins for healthcare applications for over 30 years. At LyondellBasell, we have transformed healthcare industry requirements into one of the most leading and well-known operating procedures and concepts in the industry. The success of our products is the result of our continuous commitment to our products, our customers’ requirements and our dedication to the healthcare industry, with highest product consistency, quality and reliability. Our Purell concept is not only a brand, it is a living concept with series of robust regulatory, manufacturing and supply chain operating procedures introduced and implemented by LyondellBasell over a decade ago. What makes the Purell concept work is the sum of organizational commitment, consistency and application expertise. By choosing the Purell concept you choose commitment, consistency and over 30 years of experience in the industry. About the author – “Shahin Sandino M.Sc. M.A. is the Marketing Manager for the Polyethylene Healthcare and Caps & Closures Applications at LyondellBasell based in Rotterdam, WHQ. Previously, Shahin has held Commercial and Marketing management positions in various multinational companies operating in the field of Food & Beverages, Personal Care, Pharmaceuticals, Biopharmaceuticals and Polymer industries, such as Unilever, Unichema International, Quest International and Associated British Foods (ABF) Plc. Additionally, Shahin holds a University degree in Business Economics and Masters’ degrees in Business Management and Strategic Marketing”.
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About LyondellBasell – LyondellBasell (NYSE: LYB) is one of the world’s largest plastics, chemical and refining companies. The company manufactures products at 55 sites in 18 countries. LyondellBasell products and technologies are used to make items that improve the quality of life for people around the world including packaging, electronics, automotive parts, home furnishings, construction materials and biofuels. More information about LyondellBasell can be found at www.lyondellbasell.com Email: medical@lyondellbasell.com
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CLEANING & COATINGS
Clean sweep C
leaning and coating methods can significantly affect the consistency and quality of medical device performance. However, many design engineers and manufacturers are unaware of this fact. It’s important to keep in mind device cleaning and coating considerations at JAY TOURIGNY, SENIOR every stage of design and VICE PRESIDENT, manufacturing for optimal MICROCARE MEDICAL, performance once the device is in a doctor’s use.
LOOKS AT CLEANING AND COATING, AND HOW TO OVERCOME CHALLENGES IN DEVICE DESIGN AND MANUFACTURING
Weighing options Cleaning and coating systems help achieve consistently clean products and ensure consistent performance from a device. A well-engineered process is easy to validate and will reduce costs associated with device sterilisation by removing sources of bioburden from the manufacturing process. During device manufacturing, engineers need to decide whether they must clean component parts prior to assembly, clean the final assembled product, or both. Virtually all devices will require cleaning to some extent to improve cosmetics by removing particulate, oil or inorganic contamination that results from the manufacturing process. The challenge is to specify a cleaning process that is suitable for a variety of materials and geometries that may include delicate plastic injection-moulded parts, stainless-steel micro-tubing or sophisticated mechanical assemblies. Generally, application of a lubricant coating is dictated by the desired performance of the medical device once assembled; not all devices require a coating, or lubrication. A lubricant coating is typically applied so a device will function better with reduced friction. Any device that moves side-to-side, slides, or rotates may be a candidate for a lubricant coating. Devices such as a syringe needle or cannula for injecting medicine or fluids may be cleaned and then coated with a thin film of medical grade silicone fluid to reduce friction when the needle pierces the skin. Similarly, mechanical assemblies that consist of multiple component parts, such as a surgical stapler, often need an engineered dry lubricant coating to reduce friction and minimize stacked tolerance issues. After the engineer determines whether or not a device must be cleaned or coated, the process is tailored to production volumes. In low-volume production environments, basic cleaning devices – including aerosols, dry wipes, presaturated wipes with water-based cleaners, solvents, or solvent- and
water-based cleaners – may be specified. For high-volume production the engineer will typically employ more automated cleaning systems to improve cleaning consistency and reduce costs. Those systems may be either solvent or water based and use machines engineered for the application. Lubricant coatings applied in-house will most likely be either silicone fluid or dry polytetrafluoroethylene (PTFE) based. Typically, sophisticated hydrophilic treatments are applied off the manufacturing premises because they require proprietary materials and application methods to impart surface properties that become lubricious when in contact with body fluids. In general, surfaces must be perfectly clean and dry prior to any coating application. Key factors in choosing a cleaning or coating system include worker safety, equipment costs, cost per part treated, required floor space, reduced bioburden, materials compatibility, and ease of use. Each application will have its own requirements and design and manufacturing engineers should meet with cleaning and coating providers to discuss specific concerns. In the cleaning process, the largest considerations are costeffectiveness, materials compatibility, regulatory compliance, ease of use and safety and environmental concerns. Product performance is usually the number one consideration. When the device has been manufactured and is in physicians’ hands, will it perform the way in which it was designed? Following this matter (as with the cleaning process), manufacturers are most concerned with materials’ compatibility, cost, regulatory compliance and product cosmetics as well as safety and environmental issues.
Key challenges 1. Cosmetics. Medical devices must be pristine on both clinical and cosmetic levels, as well as function flawlessly. A doctor, nurse, or patient will not accept anything less than perfection on the cleanliness and cosmetic appearance of a device. They must see a device with surfaces that are smooth and spotlessly clean. Also, a device must be pristine-clean to be properly sterilised. The optimal surface is obtained through cleaning and coating processes that quickly eliminate defects such as fingerprints, oils or stray particles that may remain from the manufacturing process. 2. Bioburden. Many factors can cause bioburden in a manufacturing process but fundamentally water is a primary growth medium for bacteria. Therefore, removing water from the manufacturing process removes a major source of
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CLEANING & COATINGS
www.cimedtech.com
bioburden issues. Solvents are often preferable to aqueous (waterbased) cleaners or coatings — solvents present an environment that is hostile to bacteria growth, and as a result greatly simplify process control requirements for eliminating bioburden. If bioburden is not properly addressed, it can result in increased difficulty in the validation of subsequent product sterilisation processes. A solvent-based cleaning process with submicron filtration can run at very high production volumes while significantly reducing bioburden issues with a minimal footprint on the cleanroom floor, as well as a minimal capital outlay compared with a water system. Also, compared with a water-based cleaning system, solvent cleaning will reduce utility costs associated with water consumption and treatment, heating water, parts drying, and maintaining proper cleanroom air conditioning. 3. Stacked tolerances. One common challenge regarding design and assembly is stacked tolerances in mechanical assemblies, which can create noticeable production variances in device actuation forces. This is a particularly common challenge with complex, single-use mechanical assemblies such as staplers and arthroscopic devices. In design and engineering, a dimensional tolerance refers to the permissible limit of variation in a physical dimension. Tolerances are specified by the design engineer to allow for reasonable leeway for imperfections and variability but without compromising performance. However, tolerances often become a challenge for design engineers and manufacturers when they begin to stack up on each other. For example, when a mechanical assembly such as a medical stapler is assembled, the tolerances of each metal stamping, spring, or plastic part may begin to combine in such a way that the assembled device requires excess force to actuate or execute. This issue is most commonly found in high-volume production, when tooling used to manufacture metal stampings, springs, and plastic parts begins to wear. Design engineers and manufacturers address stacked tolerances in several ways. Engineers may choose to design components with tighter tolerances to gain high precision. However, increased precision requires frequent inspection and maintenance of tooling and fixtures throughout the manufacturing process, which drives up finished device costs. An alternative method of dealing with stacked tolerances is to apply a lubricant coating such as PTFE or silicone on the finished assembly to reduce operating friction. Dry lubricants using PTFE particles are a low-cost way for the design engineer and manufacturer to reduce the effects of stacked tolerances. Many single-use medical devices on the market would not be commercially viable without this coating. Dry lubricants reduce the force needed to actuate or execute a device by 25 to 30% and provide a silky, almost effortless actuation for the medical professional performing the procedure. In comparison to an untreated stainless steel surface that has a coefficient of friction of 0.80, a dry PTFE lubricant can produce a remarkably low coefficient of friction of about 0.06 to the same surface. As an added benefit, PTFE lubricants are nonmigrating, so they will not degrade product cosmetics by transferring to packaging or work surfaces. 4. Maintaining calibration. For dry lubricants in particular, maintaining calibration is a challenge. Maintaining calibration of lubricant dispersions and fluids is important to the consistency and quality of the coating and the consistent performance of the device. The first step in maintaining calibration is controlling the evaporation of carrier fluid. Many PTFE dry lubricants are mixed with a carrier fluid
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<< Clean & clear: One part of the cleaning process for medical device cleaning and coating is a vapour degreaser, especially in high-volume environments >>
that evaporates very quickly. This speeds up the production process as the carrier dries quickly and leaves a consistent coating on the device. It also means that the fluid can evaporate quickly out of the vessel during the coating process. In some cases, manufacturers will add an inexact amount of carrier fluid to maintain approximate percentage saturation but this is not precise and can affect coating quality. To control evaporation and keep fluids calibrated for maximum consistency and quality, use of process-specific equipment for the cleaning and coating process is recommended. This may include hermetically sealed equipment, controlled temperature baths, specialised solvent recovery systems, engineered parts feeding systems such as hoists or conveyers, or engineered application systems such as spray or brush applicators. Also, test equipment will soon be introduced to the market that allows for instant and easy real-time measurement of PTFE content in the carrier. All are relatively simple and low cost ways to maintain lubricant calibration for coating consistency. Many coatings with PTFE micropowders require constant agitation because the particles have low hang time in the liquid carrier. This means that as the fluid sits in the vessel and parts are dipped, the PTFE particles in the fluid will sink to the bottom of the vessel. Many manufacturers address this issue by constantly agitating the fluid. However, if done improperly, this practice can have inconsistent results and lead to streaky coatings. A key solution to the short hang time of PTFE particles in a carrier fluid is to specify dispersions that use micropowders that are matched to the carrier fluid by a knowledgeable supplier. These lubricants use a premixed and supplier-calibrated formula that maintains the ratio of carrier fluid to PTFE particles to improve hang time and coating quality. It’s vital for medical device manufacturers to consider the role the cleaning and coating process can play in the performance, quality, and consistency of the finished device. There are many challenges to address in the process, but consulting with an expert cleaning or coating provider who can answer questions and concerns in an educated and timely manner is a helpful best practice.
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WELDING
Light work Tony Hoult, IPG Photonics discusses welding clear to clear polymers with laser light
t is widely accepted that absorption of electromagnetic radiation of most widely used natural non-filled, unpigmented polymers can be neglected in the wavelength range of the widely used near infra-red lasers. In the longer wavelength range from 1.2-2.5μm, most polymers start to absorb and this is known to produce molecular vibration, not electronic vibration. This absorption is very strongly dependent on the molecular structure of the material.
I
slower heating rates must be applied to avoid degradation of the polymer. This moderate volume absorption produces highly controlled melting in all clear thermally weldable polymers over a range of material thickness, typically from 0.25mm to 3mm thick. Fortunately, it is very common for material thicknesses in this range to be employed in precision moulded polymer components that may require a precision welding process such as laser welding.
Light wavelengths longer than 2.5μm will be strongly absorbed as they very effectively induce molecular oscillations in optically clear polymers. For some years, the longer established older laser technology in the form of CO2 gas lasers have been used for welding thin clear polymers, but the strong absorption of this wavelength only takes place at or very close to the surface. If any depth to the weld is required, weld times are excessively long and weld speeds are very slow as only thermal conduction can create this melting – and the low thermal conductivity of polymers is well established. So for controlled melting and welding of polymers an intermediate absorption to a depth within the material (volumetric absorption) is required. It is also well established that for realistic industrial welding speeds to be achieved between polymers, average powers > 50 watts are often required.
Laser welding of polymers using the TTIR welding technique
Currently there is only one industrialised laser source that can provide this level of average power with a wavelength in this intermediate range, and this is the thulium fibre laser which is now commercially available at up to 200 watts average power.
Although thulium fibre lasers are already employed in industry for producing consumer items such as twin walled drinks containers, the market that is most likely to prefer the precision and controllability of laser welding over competitive techniques such as ultrasonic welding is the medical device industry. Introducing a new technology into this industry clearly takes time and systems are now starting to find their way into the R&D laboratories of some larger companies. Similarly, manufacturers of ultrasonic equipment are also seeing this as a technique that complements and widens their existing product range.
Semi crystalline v amorphous polymers Thermoplastic melt-processable polymers are either amorphous or semi-crystalline. These behave differently when heated with any thermal source and in this sense laser heating is no different. What is different about laser sources – and this is seen in many other industries such as the semi-conductor and microelectronics industry – is the fact that they are highly controllable; a laser beam can be switched on and off in nanoseconds and can be focused down consistently to produce features in the range of a few microns; try doing that with a heat gun. This spatial and temporal controllability of laser sources makes the behaviour of polymers very easy to observe and control during laser heating and welding. The practical effect of this is that with semi-crystalline polymers
This laser technique that is now established in a number of industries requires that one component of the joint transmits the laser beam and another component absorbs the laser beam. This means that either the absorbing component of the joint needs to be black or dark coloured or special absorbing inks such as Clearweld need to be used. This has clearly limited the industrial application of this technique, particularly in the medical device industry where lighter colours are the accepted norm and additional additives are not accepted lightly and the market, although growing, is limited.
Thulium fibre laser systems
Additionally, as the process has become better understood, laser welding of micro-fluidic devices is increasing in importance. The galvanometer scanning technology and related software that is widely used for laser marking requires some subtle modification to allow the usually complex weld paths required to be welded successfully and good progress is also been made in this area. This is a technology to watch.
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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
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WELDING
<< Small wonder: According to Forward Technology small-diameter spin welding applications benefit from the additional process control features of the HS-OSW >>
FORWARD THINKING
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lastic welding technology offers the medical device industry precision, clean lines and the high speed to produce the latest high-performance products. However, small, highly-intricate plastic A new high-speed servo components for medical devices have been a challenge to assemble welder targets small because of their size and complexity.
diameter medical parts
One of the latest developments in plastic joining for the medical market comes from Forward Technology which recently released its next-generation HSOSW (High Speed Orientating Spin Welder). This new welder provides enhanced pneumatic process control and an intelligent servo drive controller for spin welding of small, highprecision medical components.
to gently bring parts together at one pressure setting and then welding at another higher pressure setting aims to facilitate the optimisation of weld strength while minimising weld particulate and weld flash. The modular design of the HS-OSW allows for integration of multiple weld heads into an automated rotary or in-line production system. Ethernet connectivity facilitates development of multiple head welding systems utilising two, four, or even eight weld heads and provides the means for weld data collection, weld process monitoring, and tracking of product throughout an automated production system that may include secondary operations such leak testing and part marking.
According to Forward, very small fittings, adaptors and tubular connectors as small as 3mm can be spin welded with a high degree of repeatable precision. A successful and consistent spin welding process involving smaller spin welding applications often requires a controllable degree of finesse to bring the components gently together. This is followed by a shift of process variables to deliver the appropriate rotational speed, weld pressure, and torque to reliably and consistently assemble the application. A key process control feature of the HS-OSW which provides the finesse for spin welding small and delicate applications is the dual-speed vertical head velocity control and proportional valve. It offers variable pressure control through the various stages of the spin welding process. The user may select individual pressure settings for head down speed, contact pressure, weld pressure, and cooling pressure which, says Forward, will result in greatly improved process control and improved weld cycle times. This capability reduces cycle time by 20% compared with standard single-pressure servo models and also improves repeatability.
<< Speed star: One of the latest developments in plastic joining for the medical market comes from Forward Technology which recently released its next-generation HS-OSW >>
Small-diameter spin welding applications manufactured from commonly used medical grade polymers such as polyethylene (PE), acrylic, polypropylene (PP), polycarbonate (PC), nylon, and acrylonitrile-butadiene-styrene (ABS) benefit from the additional process control features of the HS-OSW. The ability NOVEMBER - DECEMBER 2014 / MPN /37
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BIOABSORBABLE POLYMERS
A promising future Juan Granada, executive director and chief innovation officer of the Cardiovascular Research Foundation (CRF) Skirball Centre for Innovation (SCI), talks about the potential for fully bioabsorbable devices in interventional cardiology
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t the beginning of the stent era, it was commonly thought that polymers embedded in stents should not touch a patient’s arterial wall, lest inflammation occur – hence all early-generation vascular scaffolds were metallic. Most recently, researchers believed that each and every side effect resulting from first-generation drug-eluting stents was in fact related to the pro-inflammatory properties of the polymer residing inside the artery and not to the stent itself. Scientific research has enabled dramatic improvements in the quality and type of polymers used in medical devices to the point that we have been able to introduce fully bioabsorbable polymer-based scaffolds. Current experimental and human data essentially show that these polymers are as biocompatible as metallic scaffolds. This is a game changer in terms of the way that technology will be developed for vascular applications in the future. One of the biggest differences between metals and polymers in this specific application is the fact that the bioabsorbable polymers do not cage the artery by keeping it in a single biological position. As the polymer is absorbed, the artery remodels and is allowed to return to a more natural state. Now that we can embed drugs into bioabsorbable scaffolds, we can also reduce inflammation during the early phases of implantation. Because of these advantages as well as patient preference and physician perception, I am sure that the vascular implant field will slowly migrate toward a higher use of bioabsorbable materials. To get there, however, we need data. Evidence-based medicine is the most reliable influencer of clinical decision-making. At the CRF Skirball Centre for Innovation, we are doing a lot of work with bioabsorbable polymers. In the early stages, we were involved with incorporating bioabsorbable polymers into metallic scaffolds, an important stage that took away the durable polymer component. We have also studied the effects of polymer location and type on inflammation, thrombogeneicity, and endothelial cell migration. More recently, we have done a tremendous amount of work on fully bioabsorbable scaffolds related to understanding their biomechanics, vascular compatibility, and long-term vascular remodeling over time. Specifically, we have taken the fully bioabsorbable sirolimuseluting Fortitude scaffold from experimental testing all the way
into first-in-human clinical research. In a study of 13 patients, follow-up at 6 months demonstrated a biocompatibility profile comparable to that of a bare-metal stent. This is a remarkable achievement from an engineering point of view. Current randomised studies in the United States are now comparing a specific bioabsorbable scaffold to drug-eluting stents using durable polymers as a drug carrier with the goal of demonstrating clinical safety and efficacy. We have a strong foundation to be able to demonstrate bioequivalence in comparison to these metallic scaffolds in clinical trials. The future for bioabsorbable polymers is promising even beyond these initial applications. Ideally, every single device we implant in interventional cardiology would, at some point, incorporate into natural tissues. All of the lessons that we have learned with vascular scaffolds eventually could be applied to neurovascular and structural heart disease interventions. For example, looking at transcatheter aortic or mitral valve replacement, imagine a procedure where you could implant the device and then have it fully incorporate within the tissue — the device would disappear over time as the patient heals. Think about a fully-absorbable device to close patent foramen ovale (PFO), or ‘holes’ in the heart. As the device is absorbed, scar tissue would form over the PFO. That is the ideal. But developing devices and the associated technologies is not as challenging as getting them approved and commercialised. Scientific superiority is difficult to prove in a market of superb predecessors — how much better can you possibly get? If you are going to replace a metallic device with a bioabsorbable one, people will ask about the potential advantages. So, we need to find legitimate reasons to apply these technologies into new devices. In situations like vascular disease where we have already found tangible clinical advantages, we need to invest the money to demonstrate these advantages and be able to enter into the marketplace. Most of the money will come from industry. Though there is a significant amount of interest, strategic companies are still generally shy about migration into bioabsorbable polymer research. But once the first product gets to the market, I think this is going to create a wave of development that is going to be unstoppable.
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BIOCOMPATIBLE POLYMERS
<< Size counts: Katie England conducting size exclusion chromatography analysis >>
NATURAL
selection Katie England, Polymer Solutions, offers an overview of the medical applications and important analytical techniques of Chitin and Chitosan
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hitin is found naturally in the exoskeletons of arthropods and in fungi. It is the second most abundant natural polymer on earth after cellulose and structurally very similar to cellulose, which consists of β(1-4) linked D-glucose units. However, each subunit of chitin contains an acetyl amine group so that the polymer chain is made of β(14) linked N-acetylglucosamine units. This functional group allows additional hydrogen bonding between polymer chains and provides additional strength. In its pure form, chitin is flexible and translucent, but in nature it is combined with other substances to increase its strength. Industrially, chitin is extracted from crab and shrimp shells by first treating with an acid solution followed by an alkaline solution to dissolve the calcium carbonate and proteins, respectively. The alkaline solution has an additional purpose. This step can remove the acetyl group from some or all of the monomer subunits and creates chitosan. Chitosan is characterised by the percent of acetyl groups which have been removed, called the degree of deacetylation of the polymer. Unlike chitin, chitosan is water-soluble in acidic media. Both chitin and chitosan are non-toxic and biodegradable which make them useful in a number of industries including biomedical industries. Chitosan can be further chemically modified by reaction of the amine or other groups to produce various chitosan derivatives.
Medical applications Chitosan and its derivatives have characteristics based on the functional groups added which make them ideal for many biomedical applications. The derived polymers are biocompatible, biodegradable, renewable, non-toxic, anti-bacterial, anti-viral, anti-fungal and they can heal wounds (Rinaudo 2006). These attributes make them fitting for applications such as surgical sutures, dental implants, bone reinforcements, drug delivery and as artificial skin (Rinaudo 2006). Additionally, chitosan acts as a protective agent for damaged nerves by reducing cell membrane damage after injury (Cho et al 2010). Salt derivatives of chitosan also assist in drug delivery, tissue encapsulation, or as scaffold or matrix material (ASTM F2260). Biomedical materials containing chitosan and its derivatives must be well characterised in order to guarantee the correct functionality and uniformity of the final product. Many of the characteristics of chitosan mentioned above are directly related to the degree of deacetylation, molar mass, or crystallinity of the polymer. For example, chitosan’s degree of deacetylation affects solubility (Cho et al 2000). Additionally, the molar mass or molar mass distribution affects the viscosity of chitosan salts (ASTM F2602-13).
Analytical Methods There are a number of analytical methods to characterise chitosans and their derivatives. Two of the more commonly used analyses are nuclear magnetic resonance (NMR) and size exclusion chromatography with multi-angle light scattering detection (SEC-MALS). NMR – 1H Nuclear Magnetic Resonance (1H-NMR) spectroscopy determines the degree of deacetylation of a chitosan sample. The degree of deacetylation is related to functional characteristics of the polymer, such as solubility and ability to gel (ASTM F2103). In NMR analysis, the instrument compares the number of protons associated with acetyl groups of (N-acetylglucosamine) subunits with those found in the total polymer backbone and a comparison value is given. For instance, if one out of every three subunits is acetylated (33% of the subunits), then the degree of deacetylation value would be (100% – 33% = 66%) or 0.66. SEC-MALS – Size exclusion chromatography with multi-angle light scattering detection estimates the molar mass of a sample in solution. The molar mass of a particular chitosan sample will affect the viscosity. To ensure proper functioning of the product, end-products with particular viscosity requirements need to be tested in this manner. SEC-MALS can also determine the polydispersity which represents the distribution of the molar mass of a sample. Commercial chitosans will have polydispersity values between 1.5 and 3.0 (ASTM F2103-11). Chitosan is biodegradable, non-toxic, anti-microbial and renewable which makes it very useful in the biomedical field. The chemical properties such as degree of deacetylation and molar mass are related to the functionality of the polymer and these values can be tested using 1H-NMR and SECMALS. Determination of these values associated with the polymer’s characteristics is necessary to ensure a safe and effective product.
References ASTM International. Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue0Engineered Medical Product Applications. Designation: F2103-11. ASTM International. Standard Test Method for Determining the Molar Mass of Chitosan and Chitosan Salts by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS). Designation: F2602-13. Cho, Y.; Jang, J.; Park, C.R.; and Ko, S. Preparation and Solubility in Acid and Water of Partially Deacetylated Chitins. Biomacromolecules 2000 1 (4), 609-614 Cho, Y.; Shi, R.; and Borgens, R. Chitosan produces potent neuroprotection and physiological recovery following traumatic spinal cord injury. J. Exp. Biol. 2010. 213, 15131520. Heux, L.; Brugnerotto, J.; Desbrières, J.; Versali, M.-F.; and Rinaudo, M. Solid State NMR for Determination of Degree of Acetylation of Chitin and Chitosan. Biomacromolecules. 2000, 1, 746-751.
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COMPAMED
www.dataplasticsmedical.co.uk
Seeing Med This year’s Compamed takes place in Dusseldorf on 12–14 November. With over 700 exhibitors, the event promises to offer innovation and expertise for the medical device sector
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edical technology is among the fastest growing industries worldwide and this year’s Compamed (12-14 November), which boasts more than 700 exhibitors,
In conjunction with medical exhibition, Medica 2014 (4,500 exhibitors, 12-15 November), the entire value-added chain for medical technology is covered – from individual components, procedures for quality control to the finished product and related services for the complete product life-cycle (eg, finance, re-manufacturing, spare parts handling). 132,000 visitors attended Medica and Compamed in 2013. Medica is visited primarily by medical users, while engineers,
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developers and buyers of the medical technology industry form the core of the visitor pool of Compamed. Organisers of the event say that innovations presented at the show will include micro system technology solutions for mobile diagnostics, monitoring and therapy systems. There will also be exhibitors specialising in compact measurement technologies worn close to the body – wearables – and smart textiles. New materials will also be a key focus at Compamed, as will 3D printing which will bring together material and process engineering in the medical field. Drilling templates customised to individual patients and used for knee or hip surgeries, for example, are already a currently relevant field of application. Last
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COMPAMED technology, nanotechnologies, as well as production technology and process control. The Compamed Suppliers Forum will focus on current developments along the entire process chain. At the Compamed Suppliers Forum, Martin Wäny will be providing information on other possibilities of application for the smallest camera in the world, the AWAIBA NanaEye. The size of the digital camera module is exactly 1 x 1 by 1.4mm – it is not even as big as the head of a pin and is used in the field of endoscopy among other things. Individual chips make smaller, flexible endoscopic units possible. Stereo and multi-cameras allow 3D visualisation and images at multiple angles. Other lectures will deal with the wireless transmission of real-time video data, which is already a reality in several hospitals, and with a complex process to manufacture sterile cloths.
Compamed highlights One of the largest technology companies in the USA is now also planning to get into 3D printing. Hewlett Packard, thinks that the world market for 3D printers and related software and services will grow from $2.2 billion in 2012 to $11 billion US dollars in 2021. In turn, experts from the American market research company, International Data Corporation (IDC), are assuming that this year, 67% more 3D printers are going to be sold than in the previous year. The medical field is an area of application with great potential – all the way to the idea of creating entire organs with 3D printers in the future. Therefore, it is not surprising that 3D printers will also play an important role at this year’s Compamed. Dow Corning, is exhibiting at Compamed to share two exciting developments. Visitors to the company’s stand will get an exclusive glimpse of cutting-edge silicone technologies the company plans to launch early next year, and also learn about recent expansions to the company’s world-class service capabilities.
year’s Compamed addressed this topic with the ArtiVasc 3D project, which looked at the development and production of soft tissue implants using 3D printing methods. Compamed will be based around the following categories – components (including electronics, parts, hoses/tubes, filters, pumps, valves), materials, micro- and nano-technology, production (including assembly, automation and manufacturing technology, process technology, packaging) as well as testing and test systems. There will also be two forums on relevant medical supply trends. The Compamed High-Tech Forum will focus on microsystems
The planned product innovations aim to introduce new physical properties that target customer cost optimisation and offer more flexible options for the design and manufacture of intricate medical devices and components. In addition to this sneak peek, Dow Corning’s booth will also highlight the cutting-edge tools and services now available to healthcare customers at the company’s recently opened application centre in Seneffe, Belgium. Devoted exclusively to helping medical device manufacturers quickly move their products from concept to commercialisation, the centre combines Dow Corning’s silicone materials expertise with sophisticated prototyping services, technical support and testing for customers designing new products with the company’s high-performance adhesives and elastomers.
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OPTHALMICS
Seeing success 3D printing has been used as part of a process to make facial prostheses for eye cancer patients
esearchers have developed a fast and inexpensive way to make facial prostheses for eye cancer patients using facial scanning software and 3D printing, according to findings released at AAO 2014, the annual meeting of the American Academy of Ophthalmology. Its novel process can create more affordable prosthetics for any patients who have hollow sockets resulting from eye surgery following cancer or congenital deformities.
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The project started as the brainchild of David Tse, professor of ophthalmology at the Bascom Palmer Eye Institute in Florida and the Nasser Ibrahim Al-Rashid chair in ophthalmic plastic, orbital surgery and oncology. Dr Tse was treating a child with eye cancer who had both eyelids removed and underwent exenteration. The family could not afford an ocularist, so Dr. Tse raised donations to help pay for her first prosthesis. Now a teenager, she has grown out of the prosthesis and must instead wear an eye patch.
In the United States, more than 2,700 new cases of eye cancer are diagnosed each year, according to the American Cancer Society, and the mortality rate is high for the disease. Some patients undergo a life-saving surgery known as exenteration that involves removing the contents of the eye socket and other tissue. The research team hopes to bring these patients relief by providing a more affordable facial prosthesis that will allow them to live their lives more fully and with less stigma.
“Hopefully, using this quick and less expensive 3-D printing process, we can make an affordable facial prosthesis for her and also help thousands of other people like her who lack the resources to obtain one through an ocularist,” said Dr Tse.
Conventional facial prostheses can cost $10,000 to $15,000 and take weeks to produce. Each one is created by an ocularist, who makes a mould of the face, casts it using rubber and then adds the final touches such as skin colour and individual eyelashes. University of Miami researchers developed a process to manufacture facial prostheses in a matter of hours at a fraction of the cost of a traditional prosthesis using topographical scanning and 3D printing technology. Patients are scanned on the undamaged side of their face using a mobile scanner. The software then creates a mirror image. Along with a scan of the side of the face with the orbital defect, the program can mesh the two scans together to create a 3D image of the face. The topographical information then goes to a 3D printer, which translates the data into a mask formed out of injection-moulded rubber suffused with coloured pigments matching the patient’s skin tone.
Designed and developed in partnership with Dr Tse and a team at the Composite Materials Lab at the University of Miami, the 3D printed prosthesis possesses several advantages over the conventional type created by an ocularist. The material involves a proprietary mix of nanoparticles that provides extra reinforcement and makes it possible to match many shades of skin. Over time, conventional facial prostheses can discolor and fray at the edges, but nanoclay protects the material from breaking down and changing colour when exposed to moisture and light. It also prevents dirt from depositing. If the prosthesis ever needs to be replaced, reproduction can happen with the press of a button. “Once we have a patient scanned, we have the mould, so we can create a new prosthesis in no time,” said Landon Grace, director of the lab and an assistant professor of mechanical and aerospace engineering. “Our long-term goal is to help patients anywhere in the world. We could get a mobile scan, download the data in Miami, print out the prosthesis and ship it back to the patient the next day.” NOVEMBER - DECEMBER 2014 / MPN /45
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OPTHALMICS
www.cimedtech.com
The Smart approach A
smartphone-based tool may be an effective alternative to traditional ophthalmic imaging equipment in evaluating and grading severity of a diabetic eye disease, according to a new study. The results of the research indicate the lower-cost method could be useful for bringing the service to patients in isolated or underserved RESEARCH SHOWS communities.
SMARTPHONE TECHNOLOGY HAS A ROLE TO PLAY IN EYE HEALTH AND EXAMINATIONS
Approximately 7.7 million Americans have diabetic retinopathy, which is caused by elevated blood glucose (sugar) levels and can lead to vision loss and blindness. The traditional method for monitoring the progression of the disease is through retinal slitlamp biomicroscopy, which enables ophthalmologists to look at the back of the eye’s interior. This kind of examination requires a large piece of specialised equipment found only in clinical settings, posing a significant challenge for monitoring patients living in rural or low resource communities. In order to find a solution for addressing this challenge, researchers from the University of Brescia, University of Molise and Federico II University of Naples, Italy, developed a small optical adapter called D-Eye which could attach magnetically to an iPhone 5, creating a smartphone ophthalmoscope. They then used the iPhone ophthalmoscope as well as a slit-lamp biomicroscope to perform dilated retinal digital imaging on 120 patients with diabetes who were scheduled to have a routine dilated eye exam. After comparing the results of the smartphone method to the traditional one, an exact agreement between the two methods was found in 85% of the eyes and an agreement within one step (or grade of disease progression) was found in 96.7% of the eyes. In most of the one- and two-step disagreements, the severity level was graded higher by biomicroscopy grading. In the smartphone ophthalmoscopy results, nine eyes were not gradable due to small pupil or cataract. In the biomicroscopy results, the number of not gradable images was four. Therefore, while biomicroscopy is still found to be the more accurate method for grading diabetic retinopathy, researchers believe smartphone ophthalmoscopy shows great potential for use in rural or remote communities who would normally receive little to no testing at all. “Using the iPhone method is thousands of dollars cheaper than using traditional equipment,” said lead researcher Andrea Russo. “The affordability of this option could make it much easier to bring eye care to non-hospital remote or rural settings, which often lack ophthalmic medical personnel.”
Difficult-to-photograph patients Smartphone technology may also be a portable and effective tool for imaging the inside of the eye, according to results of a study. Researchers from the Ross Eye Institute at the University at Buffalo-SUNY are successfully using an iPhone application as an inexpensive, portable and effective tool for imaging the inside of the eye, including in patients who are challenging to photograph by traditional methods. 46/ MPN / NOVEMBER - DECEMBER 2014
Photography plays a critical role in documenting and tracking the progression of eye diseases. One of the most common types of ocular imaging is fundus photography. This requires a specialised low-power microscope with an attached camera to capture photos which can then be reviewed by specialists at another time or location and saved for medical documentation. The standard equipment is generally designed for the adult frame and typically stationed in specialised eye clinics. Therefore, it may not be accessible everywhere and be incompatible for those too young or too ill to maintain the required upright position. This could result in missed opportunities to document important changes in such patient subgroups. To address this problem, the researchers used the iExaminer™ smartphone system (Welch Allyn) and an iPhone to image 28 clinic and hospitalised paediatric patients with a diverse range of retinal and optic nerve conditions. The system consists of a PanOptic Ophthalmoscope (a lighted instrument to examine the inside of the eye) and an adapter that attaches the ophthalmoscope to an iPhone to enable taking photos and videos. It can image key structures of the back of the eye in a single view without necessarily requiring dilation drops. The associated app facilitates capture, storage, and transfer of data. This also makes it possible for real-time telemedicine consultation without violating patient identity as no external facial features are revealed. “This system could be useful not only to ophthalmologists, but also emergency department physicians, hospitalists and general practitioners,” said lead researcher Jiaxi Ding. “Because it can instantly capture photos and videos of the back of the eye through an undilated pupil, there is potential for prompt telemedicine consultations with an ophthalmologist and getting preliminary triage answers to the patient more quickly than waiting for standard office referral.” The researchers did note some challenges of the smartphone method, which included limited view of the peripheral retina, battery life of the ophthalmoscope when consecutively imaging multiple patients, and a learning curve in maneuvering the system. Additionally, the current setup is only FDA approved and compatible with iPhone 4 and 4S, both of which have lower camera resolution than more recent models.
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Specialist in Elastomers and Polymers for Healthcare
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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.
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PEEK
Performance PEEK
Trauma plates with 50x greater fatigue resistance compared with metal offer new treatment options and significant cost-saving potential for healthcare providers
T
rauma plates composed of a high performance polymer provide patients at risk of complications with a greater window for healing compared with metallic plates. The new trauma << Meet and greet: Invibio presented details of its Invibio device technology is based Trauma Device Technology at on the PEEK Optima Ultra the recent Orthopaedic Reinforced polymer. It Trauma Association (OTA) delivers similar mechanical meeting in Tampa >> strength to metallic plates, with 50x greater fatigue resistance. Invibio Biomaterial Solutions provider of PEEK polymer-based biomaterials, manufacturing and R&D for medical device manufacturers, presented details of its Invibio Trauma Device Technology at the recent Orthopaedic Trauma Association (OTA) meeting in Tampa. Delayed or non-unions cost healthcare providers more than $2 billion in failed operations in the US alone. Non-union rates in the literature have been detailed as high as 18% for distal femur plating. Despite this and the fact that patient risk profiles for nonunions vary enormously there are very limited material options for treating patients.
Enhanced healing saves costs “Patients who are at risk for slow or delayed healing can benefit from implants composed of PEEK Optima Ultra-Reinforced because the fatigue life is so much greater than metal. They’re more likely to be able to heal their fracture before their implant fails due to fatigue. There’s a whole host of patients that are slow to heal, including smokers and patients with diabetes, poor bone quality or open fractures, who have an enhanced potential to heal,” says David Hak, orthopaedic surgeon at Denver Health, University of Colorado. He adds, “I’ve been using the material for about two years in the proximal humerus and I’ve been very pleased with the outcome of those patients.” 48/ MPN / NOVEMBER - DECEMBER 2014
Rapid market entry Invibio Trauma Device Technology is a turnkey platform that allows medical device manufacturers to quickly design, validate and manufacture semi-rigid anatomic plates composed of PEEK Optima Ultra Reinforced polymer. “At Invibio, we’ve spent more than five years developing the expertise, design and manufacturing processes and building manufacturing facilities to quickly and cost effectively bring composite device components to market,” John Devine, emerging business director at Invibio explains. “Now, we are able to offer our customers a technology platform from which they can deliver differentiated PEEK-composite trauma implants up to three times faster than if they developed programs on their own. Customers can save as much as $1.8 million in start-up and development costs and redeploy their development staff to other business initiatives.” According to Invibio, PEEK Optima Ultra-Reinforced polymer, a composite of PEEK Optima natural polymer reinforced with continuous carbon fibres, provides the strength and fatigue resistance demanded by high-load trauma implant applications. Using PEEK Optima Ultra-Reinforced polymer, designers can alter stiffness and develop trauma implants that are less rigid than metal implants, increasing dynamic loading and promoting secondary healing at the fracture site. This Invibio Trauma Device Technology gives surgeons a new option for treating patients at high risk of developing complications related to internal trauma fixation, such as non-unions, delayed unions and implant failures.
Surgeons gain insight The imaging characteristics of PEEK Optima Ultra Reinforced give surgeons the ability to see the fracture site from all angles under x-ray. During the procedure, this can ease reduction and ensure proper alignment for healing to occur. After the procedure, it offers greater visibility of the fracture healing site so that surgeons can make more informed decisions about when to return patients to load-bearing activities.
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<< Centre piece: The government-backed centre has an advanced suite of robot building facilities offering the latest 3D printing and high-precision assembly technologies >>
INNOVATION
<< Print works: The robotics lab features 3D printing, >>
Centre of ATTENTION University of Leeds unveils national facility for innovative robotics featuring 3D printers
T
he new government-backed centre totalling £4.3 million in investment, is set to put Leeds at the forefront of UK robot design and construction. The facility is being funded as a resource not only for researchers, but also for local industry, and forging partnerships with companies interested in developing state-of-the-art robotics a key objective. Stratasys, a global provider of 3D printing and additive manufacturing solutions, has unveiled the Engineering and Physical Sciences Research Council (EPSRC) National Facility for Innovative Robotic Systems at the University of Leeds. The centre has an advanced suite of robotic building equipment in the UK, including what’s claimed to be the world’s largest multi-material 3D printer, the Objet1000 from Stratasys, as well as the Objet500 Connex3 colour, multi-material 3D printer. “Robotics has been identified by the government as one of the areas where the UK can develop a technological edge, therefore it’s our vision to build a world-leading centre for robotics and autonomous systems,” says Dr Robert Richardson, director of the facility. “We looked at the most innovative and exciting robots being developed across the world and asked ourselves what kit we’d need to build something even better. “With our 3D printing technology, we’ll be able to make robots that are smaller, more intricate, more flexible and more integrated than ever before,” adds Dr Richardson. “Leeds already has a great track record in robotics for surgical applications, patient rehabilitation, prosthetics, and exploration, but the new facility will revolutionise our ability to turn new concepts into reality.” In a UK first, the lab features the multi-material 3D printer, the Objet1000, capable of 3D printing huge 1:1 scale parts combining rigid and soft materials, all in a single build. The technology will also enable its
users to mix two base materials on-the-fly to create over a hundred new digital materials, making robot design and production more versatile than ever before. “If you think about it, combining hard and soft materials is critical to some of the most effective physical systems we know,” continues Richardson. “The human body, for instance, has soft tissues, flexible cartilages, elastic tendons and rigid bones all working closely together. “As an example, we recently developed a life-size reproduction of a human colon that includes compliant materials and was created from reconstructed MRI data using our Objet1000. We are currently developing techniques to 3D print more accurate tissue phantoms to facilitate the evaluation of surgical devices and robots.” The lab is also equipped with a 3D visualisation studio that allows robot builders to inspect digital models of robot designs in fine detail prior to being 3D printed. Completing the 3D printer line-up is Stratasys’ Objet500 Connex3 colour, multi-material 3D printer. Its unique triplejetting technology will be used to produce complex robotic parts with virtually unlimited combinations of rigid, flexible, transparent and colour materials - all in a single print run, requiring no assembly. “The National Facility for Innovative Robotics is a fantastic example of how the UK continues to invest significantly in innovation and technology,” says Andy Middleton, Stratasys’ Senior vice president and general manager EMEA. “It is always refreshing to see researchers push the boundaries of their fields using our most advanced 3D printing technology, in this case the next generation of robotics. However, sharing these design and production capabilities with local businesses will take innovation beyond the lab and into UK manufacturers, enabling them to create their own factories of the future.” NOVEMBER - DECEMBER 2014 / MPN /51
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3
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Medical Ltd
Contract Manufacturing Services
Our Manufacturing Capabilities in ISO Class 8 cleanrooms • Injection Moulding • Plastic and Tubing Extrusion • Assembly • Bonding • Tipping • Sealing Come and see us at Medica in Hall 5, Stand D11 to learn more about our wide range of contract manufacturing and OEM services! Tel. +44 (0) 117 972 8888 sales@p3-medical.com www.p3-medical.com
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Made in the UK
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COMPOUNDING
www.cimedtech.com
The real deal Plastics Color Corporation looks at anti-counterfeiting technologies for plastics to protect medical products
W
hile anti-counterfeiting technologies for thermoplastics are commonly associated with brand name protection of highend consumer/retail products, they can also play a critical safety role in functional items such as medical and pharmaceutical devices. Among the latest technologies is the MiBatch line of particle taggants from Plastics Color Corp, a provider of colourants, compounds, additive masterbatches and custom polymer technologies. According to Plastics Colour Corp, MiBatch delivers major advantages for the medical industry when it comes to risk mitigation, supply chain security, and corporate governance. “The anti-counterfeiting problem is not one limited to luxury or consumer goods,” said Tim Workman, vice president of business development for Plastics Color. “When it comes to medical and pharmaceutical applications, safety and quality of medical products can have a direct impact on the human life.” Counterfeiting is a multi-billion-dollar threat to consumers and businesses worldwide and compromises brand value and poses serious safety risks, according to Plastics Color. “MiBatch was developed as an extremely costeffective anti-counterfeiting measure enabling manufacturers and retailers to protect brand identity and ensure supply chain integrity,” explained Workman.
A product fingerprint MiBatch technology uses covert chemical or visual markers that promote anti-counterfeiting by providing a unique fingerprint to the packaging or product. These markers are created through spray pyrolysis during the manufacturing process. This patented process produces spherical particles over a wide range of compositions so that there is homogeneous composition control. This is considered a proactive approach to security and risk management. The unique taggants in MiBatch are compatible with a variety of resins to impart an extremely high level of security and verification.
MiBatch taggants are easy to authenticate but very difficult for criminals to detect and replicate. They function consistently under wide-ranging environmental conditions without affecting product performance, and each customer’s unique taggant ‘signature’ can be consistently produced at any volume. According to Plastics Colour Corp, MiBatch is an ideal anti-counterfeiting measure for the medical industry. MiBatch taggants can be used in a range of medical devices and packaging including pill bottles, syringes, tubing, surgical devices, and medical apparatuses. These taggants are an effective way to protect OEMs or brand owners in regulatory and legal claims, sayd the company and by specifying the MiBatch additive, OEMs can protect themselves against diluted and counterfeited products by proving the defective product did not meet their specified standards and thus was not their product but instead a copy.
How MiBatch works Taggants, microscopic chemical or spectral markers, are added to plastic masterbatches during the compounding process. Plastics Color customformulates these markers for each client so that no two customers have the same taggants. XRF (X-ray fluorescence) and laser detection equipment (handheld or inline) is employed to ‘read’ the embedded taggant signature and verify authenticity of the polymer, product, or component. The detection systems are tuned to look for specific elements and combinations for the unique taggant. Since MiBatch is an anti-counterfeiting taggant that is placed in the material itself – whether in the plastic packaging or the plastic product – authentication can be done at every level of the supply chain. If an OEM is having issues with supply chain security, MiBatch aims to provide an effective solution that provides authentication tools for each step of the process. OEMs are able to work with their specific security gaps and take a proactive approach to hindering counterfeiting issues from within; whether from production facilities, packaging facilities, or via the shipping process.
<< Inside story: MiBatch is an anti-counterfeiting taggant that is placed in the material itself >>
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COMPOUNDING
www.cimedtech.com
QUESTION of quality Nathan Doyle, business development manager for Compounding Solutions, has helped double the size of Compounding Solutionsâ&#x20AC;&#x2122; medical business during his three years at the company. His article highlights that quality compounds come from quality inputs
Quality Compounds come from Quality Inputs High quality, superior medical devices start with the highest quality materials and components. In the catheter tubing market quality is defined by a smooth surface, free of bumps, nibs, gels, foreign matter and/or contamination. Along with cosmetic issues, a superior compound also is easy to process, produces low start up scrap, lines out quickly and is consistent from lot to lot. Every lot of compound should be headache free and process similar if not the same as the previous lot. The processing of the compound plays such an important role in a well dispersed compound which in turn yields excellent quality medical devices. The demands of todayâ&#x20AC;&#x2122;s thin walled catheter device market begin to test the limits of current materials available. Many compounds are being used in sub 0.001 wall thickness. In medical compounds the resin and additives are scrutiniszed for the highest quality, quite often OEMâ&#x20AC;&#x2122;s are looking for USP Class VI certification on the chosen materials. By vetting these components the resulting compound should be of highest quality. However these ingredients still need to be compounded effectively to ensure consistent formulation, excellent dispersion of fillers and pigments, and a stable melt flow rate.
<< Pellets cut in half to show dispersion quality. Poor dispersion (left, highlighted in black) and good dispersion (right.) >>
Good compounding starts by drying all components and keeping them dry throughout the process. At Compounding Solutions, all of our feeders are kept under positive pressure with nNitrogen to keep water reabsorption to an absolute minimum. In the past all
Good compounding starts by drying all components and keeping them dry throughout the process.
components were weighed and then mixed by hand in a bag tumbling process then transferred to a volumetric feeder. These feeders meter a consistent volume of material by a turning screw releasing a steady quantity of material over time, which provides an economical way to meter materials that have a consistent bulk density. If two components are of different particle sizes, say a plastic resin and a radiopaque filler, there is a chance for these components to separate in the feeder due to vibrations form the turning screw. This separation causes variability within the compounding process. New technology in feeding systems are loss in weight gravimetric feeders. A loss in weight feeder is a gravimetric metering device that receives material from an upstream supply from a hopper and accurately doses the material into a process at a predetermined feed rate, typically through a turning screw(s). At the base of the feeder is a load cell that the feeder receives constant feedback from the sensitive weighing device, which ensures that the precise amount of material is delivered continuously. With the addition of a PLC driven controller the accuracy of the loss in weight feeder can be dialed in to autocorrect any potential variance. Compounding Solutions has utilised loss in weight feeders over the past 14 years; we have worked hard to constantly improve the quality of our compounds to decrease surface defects, and gels, while increasing our customer yields. Not only from lLot to lot, but from every pellet that our customers have purchased. Along with using loss in weight feeding we keep components in their own feeders to ensure the correct amount is being supplied into the compound. The typical accuracy of these feeders is +/- 0.2%. Compounding Solutions also utilizes loss in weight micro feeders, which are similar to the above but can dose in small amount on the order of 0.2lbs per hour. This is beneficial when expensive additives such as tungsten, antimicrobials, etc. are within the compound. Compounding Solutions also upgraded their capabilities last year with the addition of a loss in weight liquid feeding system. Now the same accuracy that delivers powders and pellets can be used with liquids and pastes.
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INJECTION MOULDING
www.cimedtech.com
Passing the test Medical engineering meets injection moulding technology – the story of a partnership
T
hinXXS Microtechnology manufactures disposable tests for medical diagnostics. Customers include those from the pharmaceutical and diagnostics segments with a focus on the identification of bacterial infections or cancer cells in the blood. In order to make these tests viable for laboratories as well as for hospitals and surgeries, the manufacturer must ensure they are easy to handle. This is where the company says its microtechnology specialism comes to the fore. When it was founded in 2001 as a spin-off venture of the injection moulding department of the Institut für Mikrotechnik, the company had a total of 13 employees and decided to focus on its core segment. Dieter Cronauer, member of the managing board, explains: “Micro injection moulding and assembly has always been our specialty. This is our field of expertise. Mould engineering is our unique selling point. Our customers know and appreciate this. Some of them even come from as far as California.” The entire process is fully automated and takes place behind closed doors. Today, thinXXS has 75 employees. Its injection moulding shop, assembly, logistics and packaging are located in a separate 350sqm hall and the demand is rising steadily. A total of 90% of customers are from Europe and the US, among them companies such as Daktari Diagnostics and Emerald BioSystems, German companies such as DST Diagnostische Systeme & Technologien and Belgian specialists such as Trinean. “We excel when high precision is called for. We guide our customers from the initial manufacturing concept right through to cost-efficient large-scale production. It is important to know that our customers invest millions in development diagnostics products to understand that they need high profit margins, to ensure that their investment pays off,” Cronauer points out.
Maximum precision The injection moulding shop is at the heart of the company’s facility. The in-house mould making department develops and manufactures moulds with channels and structures in the micrometre range. It produces macroscopic parts with microstructures. These parts are no larger than a credit card. The microstructures in the moulds are produced by ultra-fine precision milling machines according to drafts provided by a team of in-house engineers. The intricate pattern and structures of the minute geometries are no longer visible to the naked eye. Diagnostics mostly deals with microscopic amounts of substances. A drop of blood must suffice to identify both the infection itself and the level of infection within minutes. Blood and the substance that is integrated into the quick test’s fluid reservoir react and
<< Keeping it clean: Staff members assemble and package products under class 7 cleanroom conditions >>
quickly show a result in the separate analysis unit – similar to pregnancy tests. The channels of the plastic part that contains the test must allow the conveyance of a predefined amount of liquid at a predefined speed. Tobias Lacroix, head of micro injection moulding explains why this is a particular challenge: “The part must be extremely precise in order to accommodate the quick test’s fluidic functional design. Only a highly accurate part can guarantee a 100% reliable result. We are dealing with dimensions less than a hair’s breadth in combination with highly complex geometries.” The fact that these high-tech parts with microstructures can only be produced by an injection moulding machine that can meet the corresponding requirements is par for the course. During the production of these parts, a particle of dust could wreak havoc. Hence, the entire production process is confined to a cleanroom environment. The injection moulding machine for the production of bacterial quick tests was manufactured by Sumitomo (SHI) Demag Plastics Machinery. It operates in a class 8 cleanroom, but is also enclosed in an additional class 7 containment area, where it runs together with the downstream automation equipment. The all-electric Sumitomo (SHI) Demag IntElect 100-180 injection moulding machine is equipped with a handling system and automation system that was also supplied by the general contractor Sumitomo (SHI) Demag. Three different four-cavity moulds are operated on the machine to produce the parts that are assembled in-house into the final product – a disposable quick test. With a shot weight of about 12g, the machine produces individual components with a part weight of 2.7g in a three-shift operation. Two of the component groups are made from uncoloured PMMA, the third group is
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INJECTION MOULDING
<< She’s electric: Tobias Lacroix, head of micro injection moulding is more than happy with his new all-electric IntElect injection moulding machine from Sumitomo (SHI) Demag >>
made from blue coloured polypropylene. “We expected our injection moulding machine to achieve an extremely accurate reproduction of surface detail, a high repeatability and part tolerances in the micrometre range. We also required an automation system which conveys the finished parts directly to the assembly stations and a class 7 cleanroom. We decided to work with Sumitomo (SHI) Demag, because the company’s well thought-out concept was the most convincing and the project timeline adhered to our tight schedule. It offered a keen priceperformance ratio and we had already made positive experiences with our existing Sumitomo (SHI) Demag machine. The technical after-sales support of the company’s representatives really is outstanding,” Lacroix explains.
Behind closed doors The dried pellets are fed to the IntElect’s plasticisation unit via the feeder and metering unit IntElect. The mould – provided by the customer – is heated to 90°C with water as a medium. The
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<< Step and repeat: The injection moulding machine produces these microstructures with every shot. Each part is almost a clone of the one that was produced before >>
temperature control device is connected to the injection moulding machine via a CAN Bus interface. With an L/D ratio of 20 and a clamping force of 1,000 kN, the IntElect produces the test components within 16 seconds. The controllable activeLock non-return function ensures that no melt flows back into the screw channels after the injection phase has started. Parts such as these need highly precise and reliable processes in order to meet the narrow tolerances required by this application. A six-axis articulated arm robot manufactured by Stäubli removes the finished parts from the mould and places them in a small storage bin (KLT). When this bin is full, it moves to the conveyor belt and is transported directly to the connected assembly station. The removal area and the conveyor belt are fully encapsulated. The quality of these medical components is inspected at regular intervals: QS staff pushes a button to activate the QS tray, inserts it into the machine, and the robot places the test specimen on the tray, which is subsequently inspected and finally disposed of by the QS team. Sensors monitor the presence of the tray for inspection inside the cabin, they also monitor the deposit station, conveyor belt, robot gripper and the removal of parts from the mould. The entire process is fully automated and takes place behind closed doors. It can only be observed through a glass window in the cleanroom cabin. Lacroix is pleased: “The complete system is operating with precision and repeatability. Sumitomo (SHI) Demag fully supported us during the GMP validation and we passed the assessment without problems. I found it particularly helpful that our contacts looked after all technical and administrative matters concerning the complete line. I am really happy with everything!“
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MEDICAL IMAGING
COMMERCIAL GAIN
T
o work with CIMTEC, an innovation must be past proofof-concept with evidence that it works. CIMTEC can also act as the development arm for larger companies that are looking to outsource their development projects. CIMTEC’s technology development team provides hardware and software engineering for prototype THE CENTRE FOR development and testing in the IMAGING TECHNOLOGY broad areas of 3D visualisation, image analysis and COMMERCIALISATION mechatronics.
(CIMTEC) PROVIDES RESEARCHERS AND COMPANIES WITH A SET OF SERVICES AND CAPABILITIES ALONG THE ENTIRE COMMERCIALISATION PROCESS TO HELP TRANSLATE THEIR MEDICAL IMAGING INNOVATIONS INTO COMMERCIAL PRODUCTS FOR CLINICAL USE
Image-guided interventions and digital pathology are two of CIMTEC’s core areas of expertise. Its hardware and software patents in imageguided biopsy and therapy, as well as its licensable preprocessing and cellular component algorithms help companies propel their projects much farther and faster than they could achieve on their own, says the organisation.
Focal Healthcare is a spin-off company of CIMTEC and is developing and marketing MRIultrasound fusion biopsy and therapy systems that have potential to become the new ‘gold standard’ in prostate care by capitalising on CIMTEC’s intellectual property, as well as its technology development and commercialisation expertise in the medical imaging field. According to Focal Healthcare’s CEO: “We realised that existing products were not meeting the needs of urologists and their patients and that they could be significantly improved by tapping into CIMTEC’s services and by licensing its unique portfolio of patents. We are confident that our connection to CIMTEC is the key to making Focal’s prostate Fusion Biopsy and Fusion Therapy systems a commercial success.” “Many of our customers”, says Michael Waterston, CIMTEC’s director of business development, “simply don’t have the inhouse skills, knowledge or resources to follow through with every step and nuance required to successfully bring a product to market.” Waterston adds, “CIMTEC becomes a valuable part of each customer’s team, filling their knowledge and capacity gaps with proven expertise and medical imaging industry knowledge.” Founded in 2011, CIMTEC has been evolving its business in response to customer need, establishing new services and
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connecting to outside expertise to accelerate its customers’ time to market. Through business development services, CIMTEC helps customers establish their value propositions and create goto-market plans; including assessing the intellectual property and regulatory landscapes in the markets they wish to enter (US, Europe, and Canada). CIMTEC’s active engagement as subject matter experts, writing proposals and providing coaching in preparation for pitch meetings with funders, positively affects customers’ ability to raise funds and move their products closer to clinical use. Understanding who to approach and what sequence of steps to take are overarching challenges for new entrepreneurs. Because CIMTEC has a full range of in-house expertise, it believes the benefits of working with them are significant for researchers and young companies with no prior commercialisation experience and limited time to seek out individual service providers. The depth and breadth of CIMTEC’s knowledge and connectivity helps mitigate many of the barriers associated with bringing medical imaging technology to market, such as access to funding and to clinicians. CIMTEC collaborates with several healthcare centres, which gives its customers access to exemplary clinical and laboratory resources that help test prototypes and give valuable feedback about ease of use and how to improve the design and workflow of products. In addition, CIMTEC’s recently launched clinical testing services integrates their expertise in medical imaging with hands-on project management experience, and extensive knowledge of regulatory requirements and Good Clinical Practice (GCP) regulations, making it easier for customers to achieve a range of goals such as generating clinical data to support pre-market regulatory submissions, or to demonstrate clinical utility for driving adoption and reimbursement. Isis Innovation, the technology transfer arm at Oxford University, is working in collaboration with CIMTEC to commercialise its OxEMA system through startup company, Enhanced Medical. CIMTEC’s engineering services will develop the system which uses a combination of electromagnetic and acoustic waves to produce MRI-like images at a cost comparable to the much cheaper ultrasound. Tom Hockaday, managing director of Isis Innovation, said: “We are pleased to have entered into a unique relationship with CIMTEC, who are extremely well placed to advance the Oxford technology.”
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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...
ENTER THE DRAGON MPN: Who are you and what do you do? NB: I’m Neomi Bennett and I am the inventor of the multi award-winning Neo-Slip, an aid to support the application of anti-embolism stockings. Alongside this I work at my local hospital and give educational talks to older people at day centres and young people in schools. MPN: What is your latest service/innovation? NB: Neo-Slip is a low friction pouch that goes onto the foot before applying the tightly fitted stocking. The pouch creates a lubricated environment that supports the smooth application of the stocking. The product has received critical acclaim in the UK and won 14 awards for its simple design, ingenuity and efficacy. These include the prestigious Nursing Standard, Nursing Times, National Patient Safety Award and NACUE’s people choice awards. I was a finalist in the Royal College of Nursing Awards 2011 and highly commended in the Lloyds TSB Enterprise Awards 2013, winning the Bright Ideas competition. And I was once again a finalist in Smarta100 award for the most innovative business and more recently I have been shortlisted for the Pitch competition. MPN: What have you focussed on recently? NB: I have recently been seeking investment on Dragons’ Den. I met Deborah Meaden at an event last year. She encouraged me to apply to go into the Den to pitch Neo-Slip to her and the other Dragons. The application process was complex and involved extensive due diligence. Despite not winning over the Dragons, I have seen a huge increase in the customer base following my pitch to the investors. Of course, it would have been great to have secured a Dragon as a business partner; however the experience has helped me enormously As well as this I am still building on its successful launch in 2011, I have won a funding award from UnLtd (a charity which supports social enterprises) and began supplying hospitals, independent pharmacies and nursing homes. The Epsom Orthopaedic Centre has purchased Neo-Slip and I am working closely with other major hospitals. I have received an invitation to tender from NHS England and I am also in advanced negotiations with a private health provider with multiple branches across the UK.
Whilst already having several distribution deals agreed with pharmacies in the UK, Neo-Slip is now making significant inroads in the USA, Canada and Europe. Recently I was also supported by UKTI to exhibit Neo-Slip in Taiwan at an international invention show, where I was awarded a silver medal and received a certificate of Diploma from Italian inventors group. I am still currently seeking to raise £7,000 to continue my work to save lives and reduce DVT. MPN: How can you benefit the medical sector? NB: Neo-Slip was an instant hit within the medical industry; it is a simple and affordable solution to an old problem. While training to become a nurse at Kingston University, I was given a risk assessment essay to look for and solve a problem. I decided to look at the stockings because she noticed many patients were reluctant to use anti embolism stockings as they are extremely tight and difficult to put on. As 25,000 people die of DVT each year in the UK, I began experimenting with materials and looking for ways to make application easier. I have presented Neo-Slip to business secretary Vince Cable and in 2011 was invited to Downing Street to meet prime minister David Cameron, who had expressed his personal interest in the invention. I have also met with the duke of Gloucester at Kensington palace who said there should be more nurses like myself. Minister of state for universities and Science David Willet also expressed an interest in Neo-Slip. I am now involved with a parliamentary group to prevent DVT, regularly attending meetings at the House of Commons. I have also invited to the British Embassy in Austria by UKTI to present her product to European Healthcare businesses.
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