N AMERIC AN EDITION
MEDICAL PLASTICS news
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ALL THINGS BEING EQUAL
WHY GIRLS JUST WANNA HAVE FEMTECH...
CATHETER DESIGN AT ITS BEST ADVANCES IN TUBING ANTIMICROBIALS FOR MEDICAL PLASTICS
ISSUE 3
Jul/Aug/Sept 2017
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ADVANCING MEDICAL PLASTICS
Balloon Catheters and Balloons W O R K
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CONTENTS MPN North America | Issue 3
Regulars
Features
3 Comment
10 All things being equal With the rise of a new sector dedicated to female health products and devices – femtech – Lu Rahman asks whether this might help boost the number of women in healthtech careers?
5 News focus FDA announces digital health pilot scheme to boost innovation 6 Digital spy 9 News analysis Medical device market activity shows no sign of abating, says industry expert 32 Back to the future The medtech info you really need to know
13 The real deal Reece Armstrong looks at anti-counterfeiting 14 Vapor trail Steris Finn-Aqua takes a look at terminal sterilization of packaged products using vaporized hydrogen peroxide
17 Automatic for the people Injection molding focus 22 Design for life Teleflex Medical OEM and Conair offer expertise on catheter production 27 Do the rounds Natvar explains how the latest generation of microextrusion medical tubing opens doors to new procedures 30 Got the bug? Foster Corporation looks in detail at antimicrobial masterbatches for medical plastics
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Carclo Technical Plastics, 600 Depot St, Latrobe Pa. 15650. Tel: (724)-539-1833 Email: sales@carclo-plc.com www.carclo-ctp.com
CREDITS
EDITOR’S
comment
group editor | lu rahman deputy group editor | dave gray reporter | reece armstrong advertising | gaurav avasthi art | sam hamlyn graphic design | matt clarke publisher | duncan wood Medical Plastics News is available on free subscription to readers qualifying under the publisher’s terms of control. Those outside the criteria may subscribe at the following annual rates: UK and Europe: FREE North America: $249 Rest of the world: $249 subscription enquiries to subscriptions@rapidnews.com
Medical Plastics News is published by: Rapid Life Sciences Ltd, Carlton House, Sandpiper Way, Chester Business Park, Chester, CH4 9QE T: +44(0)1244 680222 F: +44(0)1244 671074 © 2017 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. ISSN No:
2047 - 4741 (Print) 2047 - 475X (Digital)
The shape of things to come: How digital health offers so much potential for the medtech sector
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PN has been flying the flag for digital health for a few years now and thanks to our sister site DigitalHealthAge.com we report on the latest trends and technology coming out of this exciting sector. It’s encouraging to learn about the FDA’s digital health pilot scheme. It’s aim to foster innovation by fasttracking digital health companies through the FDA’s approval process is a positive move for the industry, and businesses looking to expand into the sector. As part of its digital health innovation plan, FDA commissioner, Scott Gottlieb aims to provide clear rules for developers so that a productby-product basis becomes a thing of the past. It’s interesting to see how quickly the digital health landscape and the devices within the sector, have changed since we launched DigitalHealthAge.com just over two years ago. At the time the wearable explosion dominated. Devices to allow patients to administer drugs in their own home, or monitor their own conditions and feed data back to their physician were viewed as pivotal, allowing us all to take better control of our health while improving the patient experience. With major players like Apple and Nokia joining the party, and medical device manufacturers taking
a serious look at connected devices and issues such as cyber-security, it became obvious that this sector was here to stay. The diversity of technology available is impressive but the thing that excites me is the way the sector adapts and reacts to what each of us might need as individuals. Technology is already addressing a host of conditions – diabetes, hearing issues, skin cancer and eating disorders, for example – and the way that data and information is shared offers potential for combatting future illness. And of course, medical devices are a key factor in making that happen.
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The diversity of technology available is impressive but the thing that excites me is the way the sector adapts.
Thanks to the sector’s ability to meet the needs of the individual, the femtech market has really taken off. Specifically aimed at the female market with products addressing fertility and contraception among others, the market offers significant potential for start-ups. Given the fact that many femtech companies have women at the helm, it looks like the digital health sector not only has the ability to shape itself to address individual needs but could also hold the key to getting more women in key business roles. With the FDA’s approach to digital health, this is great news for medtech companies in or looking at this space.
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NEWS FOCUS
FDA announces digital health pilot scheme to boost innovation
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o help foster digital health innovations, the FDA has released guidance on medical software to help streamline its review procedure.
The FDA has announced a programme that could fast-track digital health companies through its approval process.
The digital health market is estimated to exceed $379 billion by 2024, according to a research report by Global Market Insights. FDA commissioner Scott Gottlieb, announced the Pre-Cert for Software Pilot to help establish an approach towards certifying digital health developers. This approach is different from the FDA’s current method of evaluating traditional medical products, which has to be done on a product-by-product basis.
In his blog, Gottlieb wrote: “FDA’s traditional approach to medical devices is not well suited to these products. We need to make sure our approach to innovative products with continual updates and upgrades is efficient and that it fosters, not impedes, innovation. “We need a regulatory framework that accommodates the distinctive nature of digital health technology, its clinical promise, the unique user interface, and industry’s compressed commercial cycle of new product introductions.” The pilot programme will include nine software firms, ranging from small start-ups to large companies, which
develop both high and low risk products. The criteria for those selected is broad, Gottlieb states, as the FDA wishes to accommodate a range of participants and technologies. According to CNBC, “even the harshest critics are excited”. It quotes Bradley Merrill Thompson, lawyer with Epstein, Becker & Green and FDA expert as saying: “I guess I’ve grown cynical in my old age…[but] I think the idea of a pilot program is brilliant.” Last month CNBC reported that Merrill Thompson was already showing positive support for Gottlieb’s plan: “Holy smokes,” he said. “I feel like I’ve died and gone to heaven.” This year has seen the FDA addressing the need for better regulation surrounding digital health products. The agency announced the Digital Health Innovation Plan to help foster “innovation at the intersection of medicine and digital health technology.” The plan involves the FDA making sure it has the right policies to promote safe and effective technologies, including the adoption of sufficient regulation. Alongside this announcement, the FDA released an action plan that provides details and a timeline of the agency’s digital health efforts. The Pre-Cert for Software Pilot launched on 1 August and companies will be able to submit a statement to be considered.
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DIGITAL
spy
Why a US health professional isn’t happy about this fertility app…
TECHNOLOGY UPDATE
THAT ALSO HAPPENS TO BE A MEDICAL DEVICE
www.invibio.com
www.naturalcycles.com
In it to win it:
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INVIBIO AND CARBOFIX TEAM UP WITH UK SPRINTER FOR TRAUMA IMPLANT
K Olympic sprinter James Ellington has joined forces with the UK´s Invibio Biomaterial Solutions and CarboFix Orthopedics on his road to recovery. His ambition is to return to the world stage of athletic competition after a motorcycle accident in Tenerife. The two companies and the athlete share a passion for pushing boundaries; for James Ellington, mentally and physically first in sport and now in recovery, and for CarboFix and Invibio with innovative biomaterials and devices that have the potential to change the treatment of trauma fractures. For patients recovering from traumatic injuries this could serve as an inspiration not to lose track of their goals and passion. “In extreme situations, it’s important not to lose faith and to consider all (therapeutic) options available,” explained Ellington. “I had a severe tibia fracture, and was offered two choices to fix it: a traditional titanium nail or a CarboFix nail using a relatively new, but promising carbon fibre, composite technology. For me, it’s all about giving myself the best chance of achieving my goal and returning to competitive athletics. I
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DIGITAL NEWS
chose the CarboFix nail because it’s lighter weight and for its faster healing potential.” “The rod is made from a new composite polymer. It’s strong, in a way that’s similar to metal implants, but not as stiff, which means it has the capability to stress the bone more and provide some micromotion, so it works more like natural bone. The idea is that this will help support a quicker recovery – which is what convinced me this was the right path for me.” With trauma implants made from Invibio’s PeekOptima Ultra-Reinforced, a composite polymer, CarboFix Orthopedics is hoping to support Ellington and other patients in a similar position. Ron Szekely, the company´s vice president of sales and marketing, said: “The aim itself to get back on track is fantastic, whether that’s the athletic track or returning to other individual recovery goals. This can be an important driver for rehabilitation. In addition to dedication and enthusiasm, patients need to have access to innovative medical devices that can support this. At CarboFix we believe in the potential of changing trauma treatment to improve the quality of life for many patients.”
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arlier this year the Natural Cycles fertility tracking app was approved as a class IIb medical device by worldwide regulatory body, Tüv Süd. It works by identifying a woman’s ovulation and fertile window by tracking her period and temperature. The data is recorded on the app which then uses an algorithm to determining whether women are fertile on any specific day. Women can use the app to help prevent, or plan a pregnancy.
regulatory approved contraception to use besides, condoms, the pill and IUDs, says its maker. Dr Elina Berglund, co-founder of Natural Cycles said: “Our high quality clinical studies, together with the required regulatory approvals, means we can provide women everywhere with a new option for contraception.”
Dr Carol Dunetz of NYU Langone Gynecology Associates told News 12: “There are a lot of variables to consider. To get the success rate they’re claiming, you have to disregard all these variables.” While Dunetz may not be keen on the product, its classification as a medical device means that women have access to a clinically tested,
DIGITAL UPDATE
Ask and you shall receive On-demand molding service launched
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www.protolabs.com
igital manufacturing company Proto Labs has a launched an on-demand manufacturing service for molded parts. The company says that there has been a gap in manufacturing services for low-volume, custom-molded components. Companies had to purchase in large volumes to meet the minimum order quantities required by traditional manufacturers, and work with several parties to when covering prototyping to final part production. Both would add cost and time to part procurement. Proto Labs’ offering addresses the needs of both prototyping and on-demand manufacturing.
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“Since every manufacturing project is different, our two injection molding options let customers begin to focus on what is really needed from their tooling,” explained Becky Cater, global product manager for injection molding at Proto Labs. “Whether it’s a product development need for molded prototypes or a strategic partnership for on-demand production parts, we now have a total solution for the entire life cycle of a product.” Proto Labs has also opened its first metrology lab for enhanced inspection reporting on end-use production parts.
DIGITAL SPY
DIGITAL SPY
www.cochlear.com
Sound business: FDA gives hearing device the thumbs up
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he FDA has approved a device to help users hear better on their Apple devices.
the last place the sound processor was connected to the paired device.
The Cochlear Nucleus 7 Sound Processor, is said to be the smallest and lightest behind-theear implant available on the market and allows users to hear, control, monitor and customise their hearing on an iPhone, iPad or iPod.
Jan Janssen, senior vice president, Research and Development, Cochlear, said: “The ability to control both hearing solutions through an iPhone or iPod touch and provide a seamless hearing experience between them is a remarkable technological step forward. At Cochlear, we design devices to give recipients greater flexibility to personalise their settings and manage their hearing loss on a daily basis, and these new solutions offer that experience like never before.”
Chris Smith, Cochlear CEO and president, said: “The approval of the Nucleus 7 Sound Processor is a turning point for people with hearing loss, opening the door for them to make phone calls, listen to music in highquality stereo sound, watch videos and have FaceTime calls streamed directly to their cochlear implant. This new sound processor builds on our long-standing commitment to help more people with hearing loss connect with others and live a full life.”
POINT
Easy Listening ‘MEDTALK’ PODCAST LAUNCHES FOR MEDTECH, DIGITAL HEALTH AND PHARMA COMMUNITY
The device includes a new hearing tracker which can record when the sound processor coil doesn’t detect the implant coil, and a time in speech feature which measures the amount of time spent in speech environments. If users lose their implant they can find it through the Nucleus Smart App to determine
MATERIAL UPDATE
Hydrophilic coating technology available www.teleflexmedicaloem.com
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eleflex Medical OEM, is releasing a proprietary, hydrophilic surface coating for polymerbased devices that are navigated through the vascular system. The company says that the coating performs favorably in terms of lubricity and extended durability when compared with other coatings and has proven biocompatibility and shelf-life stability. It also exhibits low particulate count in testing, and outstanding adhesion to the substrate material. The coating can be customized to optimize certain performance characteristics based on specific user needs.
talking
Similar to other hydrophilic coatings, Teleflex Medical OEM says this coating may reduce the required insertion force which may result in improved control, placement, and tracking of a device. Applications for this surface technology include introducers, diagnostic catheters, balloon catheters, and components.
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What’s so different about this podcast? Well, ever heard of inhalable chocolate? Do you know the link between F1 and infant care? Want to know what ‘femtech’ means? This podcast answers all these questions and more. The podcast, initially a monthly production, will provide an informal discussion on the latest innovations for the healthcare sector. And who’s behind it? The editors of four of the medical sector’s leading publications. The team behind the MedTalk podcast are Lu Rahman, group editor, Medical Plastics News, Fliss Thomas, editor of European Pharmaceutical Manufacturer, Reece Armstrong, reporter on Digital Health Age, and Dave Gray, editor of Med-Tech Innovation magazine. So why should we listen to it? Episode one, which is available now, looks at the rise of ‘femtech’, the emerging field of connected medical devices aimed at feminine health. The team also looks at the liquidation of Jawbone – formerly one of the major brands in wearable fitness trackers – and what it signals about the rapidly changing digital health sector. Other innovations featured in episode one include inhalable chocolate and an infant transport device which borrows from Formula 1 technology. Why now? Dave Gray explains: “We wanted to bring our four media brands together to create something for anyone with a stake in the life sciences and healthcare industry. “Increasingly our sectors are converging and we find ourselves discussing crossover content on a daily basis. These discussions often provoke further debate and great content ideas – so we thought the time was right to translate that into a podcast. “We also really wanted to keep things quite light. This podcast is really just a recording of our editorial meeting – hopefully it will engage others with an active interest in health and medicine technology.”
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NEWS ANALYSIS
Medical device market activity shows no sign of abating, says industry expert
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s we pass the midpoint of 2017, the medtech industry seems to be wrestling with several issues: healthcare reform; medical Mark Bonifacio, device tax; regulatory Bonifacio Consulting anxiety, and outlandish Services, assesses political leadership. Some the medical device matters are becoming manufacturing and clearer — President Trump’s outsourcing market, choice (and the US Senate’s confirmation) of Scott and highlights the Gottlieb, as US Food and flurry of deals, Drug Administration (FDA) activity, and commissioner bodes well industry news for the industry, as the new chief has long been a critic of the agency’s slow and protracted drug and medical device approval processes.
M&A activity There has been no shortage of deals over the last three months. The most significant on the OEM side was Becton Dickinson and Company’s blockbuster $24billion acquisition of CR Bard, and Cardinal Health’s $6.1billion acquisition of Medtronic’s legacy medical supplies business (the latter’s Covidien, Kendall, and Sherwood brands). In the contract manufacturing (CM) space, TE Connectivity continued its platformbuilding strategy by adding Microgroup to its recent collection of Creganna Medical Group and AdvancedCath to assemble a major catheter CM player.
TE competitor Molex also has grown through acquisition and gained market share in the medical device CM space with last summer’s purchase of PhilipsMedisize. Molex and other firms remain active and poised to add additional assets to their medical device CM businesses. BD revealed it was funding its purchase of CR Bard (the largest deal in BD’s 120-year-old existence) with $1.7 billion in cash, $10 billion in new debt, and $4.5 billion in equity and equity-related securities. Bard shareholders receive $8 billion in BD common stock and will own about 15% of the company after the transaction closes. While many industry analysts have viewed the deal favorably, it comes at steep price for BD: 26.9 P/E ratio, approximately six times sales and at a 25% premium to the company’s April 21 closing stock price. In announcing TE Connectivity’s latest acquisition to customers on May 1, senior vice president and general manager Paraic Curtis noted how the MicroGroup deal is the latest in a string of acquisitions TE has made in recent years to strengthen its medical device design and manufacturing capabilities. While Curtis did not disclose deal terms, it is reportedly almost 12 times the company’s EBITDA earnings.
Valuations and competition for assets continue to be at some of the highest levels seen in the last several years, with no near-term end in sight. Although dollar value has fallen in some cases, the overall number of deals is at the highest level in nearly a decade (2008-2009). Major OEMs, strategic platforms, out-ofmarket strategics, and private equity (PE) are all competing for assets in the space, making for a good sellers’ market.. There is evidence that larger OEMs and CMs (more than $500 million in sales) will push further down the market to acquire smaller niche assets as the more established, larger, actionable assets are gobbled up. Key drivers of this trend include OEM consolidation and the need to acquire new capabilities, global capacity, or simply, additional scale. Against a backdrop of economic stability and global growth, historically low interest rates, and large amounts of unused cash on PE and corporate balance sheets, this trend will likely continue at least through early next year.
A familiar face at the FDA Gottlieb has been a frequent advocate for quicker drug approvals and looser off-label marketing regulations. The industry generally regards him as an advocate for more flexible approaches to evaluating new drugs and clinical trials although due to his consultant work and investment choices, some Democrats — like US Senator Patty Murray, opposed Gottleib’ s nomination over his ‘unprecedented industry ties’. Gottlieb has the job of balancing Trump’s pledge to ease FDA regulations to ensure drugs reach the market more quickly while safeguarding the public against dangerous pharmaceuticals that have not been properly vetted. A recently released Journal of the American Medical Association study published by Yale University researchers claimed that one-third of all US drugs approved for sale over a 10-year period were subject to post-approval ‘safety events,’ including new warnings on labels, and safety advisories to doctors and the public. Gottleib has pledged to uphold the FDA’s reputation as the world’s ‘gold standard’ for drug approval.
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NEWS ANALYSIS
ALL THINGS BEING EQUAL
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’ve worked in the medtech sector for over three years and in that time, it’s still a male dominated world at the top. Visit some trade shows, exhibitions or conferences and sometimes you might wonder where the women are.
The lack of women in high-ranking medtech positions is nothing new. But is there change on the horizon? With the rise of a new sector dedicated to female health products and devices – femtech – Lu Rahman asks whether this might help boost the number of women in healthtech careers?
It’s a strange one. In many areas of science women are well represented. Take medicine. According to the UK’s Kings Fund, numbers of women in medicine have grown considerably in the last 15 years and now make up more than half of all medical students. But when it comes to technology-based healthcare, or running medical device or medtech businesses, the number of women holding board-level jobs is disappointingly low.
According to the Joint Council for Qualifications in the UK, the uptake of STEM GCSE subjects in boys and girls, is largely equal. However, only 20% of physics students at A level are female and only 9% of the engineering workforce is female, says the Women’s Engineering Society.
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Last year WISE, the campaign for gender balance in science, technology and engineering in the UK looked at the number of women on FTSE 100 boards. It noted: “In this year’s list, there are only six companies across the FTSE 100 with only one woman on the board and 60% of companies now have more than two women on the board of directors. Within the STEM sector the number of companies reaching this milestone has increased significantly since 2015. However, the STEM sector still lags behind the non-STEM sector where 65% of companies have hit this benchmark.” In the US, Rock Health’s The State of Women in Healthcare reports are worth reading. In 2015 Halle Tecco, covered an update on the report: “Despite making up more than half the healthcare workforce, women represent only 21% of executives and 21% of board members at Fortune 500 healthcare companies. Of the 125 women who carry an executive title, only five serve in operating roles as COO or president. And there’s only one woman CEO of a Fortune 500 healthcare company.
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COVER STORY
“We know from our funding data that women make up only 6% of digital health CEOs funded in the last four years. When we looked at the gender breakdown of the 148 VC firms investing in digital health, we understood why. Women make up only 10% of partners, those responsible for making final investment decisions. In fact, 75 of those firms have zero women partners (including Highland Capital, Third Rock, Sequoia, Shasta Ventures). Venture firms with women investment partners are three times more likely to invest in companies with women CEOs. It’s no wonder women CEOs aren’t getting funded.”
Importance of role models It’s disappointing reading and it would be easy to focus on the negatives. However, one of the key drivers to encouraging females into top jobs, is the ability to draw upon positive role models. The life science and medtech industries might not boast the same level of female numbers as the medical profession but there is a raft of women in high level careers providing inspiration for the younger generation to consider a healthtech-based career. The WISE website is a great source of information and inspiration. Featuring role models such as Siobhán O’Connor, lecturer in nursing informatics, University of Manchester, it helps encourage young women into science tech-based roles. O’ Connor says: “In particular, the digital health field has been growing exponentially over the last number of years. Even though it is still in its infancy the possibility of applying all sorts of technology, from mobile apps, to various Internet services, social media, wearable technologies and the emergence of Big Data and the Internet of Things, is huge and is why I now love working in health technology.”
Is the answer femtech? There’s a new term on medtech tongues, femtech – health technology aimed at the female market. We’ve seen years of products dedicated to the male section of society but with more or less half the population made up of women, there’s clearly an unmet need. According to Venturebeat the term femtech came from Ida Tin, founder and CEO of Clue, a period tracking app. As materials become increasingly sophisticated and sensor technology continues to advance, these can be used in a range of medical devices and wearables aimed at the female market, particularly pregnancy and family planning. And the femtech market is big business – said to be worth $55bn in 2015 by KPMG. Products such as the Priya Ring highlight how the market has taken advantage of technology. Described as offering a ‘level of precision that no other ovulation prediction method can’, the ring device features a sensor that monitors temperature to detect changes that take place before ovulation, alerting the wearer when they are at their most fertile. Stella Wooder, head of project management, Team Consulting, has picked up on the rise of connected female devices. She commented: “Connected devices focusing on women’s health are still relative neophytes, and it is not yet clear what the future holds. My prediction (perhaps more of a hope) is that connected devices may help make ‘routine’ screening programmes for cervical cancer, chlamydia and HPV, for example, more robust.” The cervical cancer market is a significant opportunity for connected medical devices. One of the most recent to hit the headlines has been the ‘pocket colposcope’ developed by a team of researchers at Duke University, North Carolina. When
the digital health disruption first arrived, patient empowerment was a real buzz phrase and this device aims to do just that. By connecting to a laptop or a smartphone, say its developers, it could eventually be used by women to self-screen for cervical cancer. According to the university, over 80% of the volunteers that tried the device said they were able to get a good image. As the femtech market opens up, there’s a chance it could have huge appeal to younger women’s career options. There are already many women heading up some of these new and exciting companies. The brains behind the Ava fertility bracelet is Lea von Bidder. Designed for personal and professional healthcare use, the bracelet is designed for women who want to monitor their health when trying to conceive. Speaking to About Time magazine, von Bidder outlined her journey in femtech: “I deeply care about women’s health and see it as one key component to women’s empowerment – this cause has always been something that deeply mattered to me. My interest and involvement has increased since I left university for the professional world, where we still clearly experience the lack of women in higher positions and founding roles. Helping women manage their cycle and giving them accessible, precise insights about their health and wellbeing won’t solve workplace equality issues, but it can help.” Tania Boler is one of the co-founders of Chairo and a clear role model for the younger generation. With a Phd in women’s health, and having held a range of leadership positions such as global director of research and innovation at Marie Stopes, and team leader for HIV prevention at UNESCO, Boler is behind the Elvie, a connected silicone device designed to improve women’s pelvic floors. The product has received extensive media coverage and fans apparently include Khloe Kardashian and Gwyneth Paltrow, according to City AM. In an article with the site, Boler’s insight into women’s healthcare highlights why the female perspective is valuable in this area. “Medical devices, particularly for women, are kind of really uncomfortable, difficult to use, very utilitarian in their design so for us what we’ve done with the first product and what we’re doing for future products is all about taking kind of neglected medical devices and turning them more into consumer products that people like to use,” she told Francesca Washtell. Similarly, CEO of The Flex Company, Lauren Schulte, used her own desire to find an alternative to the tampon, to create a medical device company. She told Forbes: “In the last 80 years, we’ve put a man on the moon, we’ve invented television, we’ve invented the internet, we’ve mapped the human genome, and we’ve still seen no change. The tampons that were made in the 1930s are still by and large the same product that we use today.” The Flex is made from medical-grade polymer and has been designed to offer a range of advantages over normal tampons. According to the Independent, the company, which has had wide-ranging media coverage, raised over $4m (£3.06m) in 2016. Things may not be about to change overnight but the growth of the femtech market may hold real potential when it comes encouraging young women into medtech careers. The future of femtech looks exciting and the more we can do to boost the number of females into healthtech careers, the better. Let’s hope that over the next three years, we start to see a real change in the sector.
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INTERVIEW
Helping fight the medical product counterfeiting epidemic with their collaborative system Plastiward, are specialty chemical company Clariant and security provider SICPA. MPN reporter Reece Armstrong finds out more about the companies’ efforts to fight fake products.
The real deal HOW COUNTERFEITING IS BEING FOUGHT WITHIN THE MEDICAL DEVICE SECTOR
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ccording to Yann Ischi, SICPA’s director of New Channels and partnership, the anticounterfeiting collaboration between the companies arose through their desire to bring a “system or solution to the market to help fight counterfeiting” in the plastic medical devices sector. Plastiward was announced during CPhI Worldwide 2016 and was also presented at CPhI India, due to the country’s developments in the medical device and pharmaceutical markets. India’s medical device “market is placed at somewhere between $4.4-7 billion,” said Steve Duckworth, Clariant’s head of Global Healthcare Polymer Solutions. “We launched Plastiward at the end of last year at CPhI. That was with a deliberate intent because India is an important marketplace not only for domestic consumption but it’s also an attractive marketplace for people starting to produce devices there,” he added. The rising market in India means medical devices are at risk of being counterfeited. “India also represents an important source of many off-patent/ generic drugs; also under the same threat of counterfeits as ‘patented pharmaceutical,” Duckworth continued. It is hoped Plastiward can help stem the problem and make drugs and devices safer globally. Plastiward works by using proprietary taggants developed by SICPA which are delivered to Clariant’s Mevopur production plants. The taggants are
embedded into polymers used in medical devices and pharmaceutical packaging where they can be monitored in real-time using SICPA’s deployment and monitoring platform. “The whole idea here is to help pharma and medical devices companies bring safe medicines to the market; and the key idea is really to bring protection as close as possible to the drug. By embedding our security technology directly into the polymers used to produce plastic medical devices, we get that security very close to the medication. We also use a monitoring system allowing for real-time detection. What makes our approach unique is that risk management features at the heart of our process” Ischi revealed. Duckworth explained that whilst taggants already exist, companies are hindered by the time it takes to collect the data on products in the field which then have to be analysed to determine if they are fake. This time lapse means that there’s more chance of counterfeit medical devices reaching patients.
companies are actively creating awareness around that. What we’re doing is giving them the means to do something about it on the outside as part of their mission to bring safe medicines to the patient.” Duckworth added: “You have copies which are extremely difficult to detect and often even skilled doctors cannot tell the difference. This is quite scary. There are numbers that are floating around, they say between 6%-8% of all medical devices are fake.” The risk of encountering a counterfeit medical device increases with the rise of chronic diseases. Ischi explained: “Importantly, chronic diseases like diabetes or asthma, where people will repeatedly use devices, enormously increase the chance to encounter a counterfeit, especially if you travel and you don’t know the place where you buy your drugs or your devices. The awareness of population is rising as is the demand for a very strong monitoring system.”
Duckworth said: “The quicker you can authenticate, the quicker you can get real-time data and the quicker you can take action. One of Plastiward’s major advantages is that you can detect any issues in the warehouse, back in the HQ you’re able to see in real-time where the problem has occurred, and then take action.”
To have one solution to challenge counterfeiting isn’t good enough and Clariant realises this. Both the EU Falsified Medicine Directive (FMD) and the US Drug Supply Chain Security Act (DSCSA) strengthen the monitoring of medical devices and pharmaceuticals globally. Clariant and SICPA’s system intends to support these laws going into place.
While Clariant and SICPA are aware of counterfeiting, is the general public conscious of the dangers that it poses? Apparently not. Ischi said: “It’s a huge issue and a number of pharmaceutical
“With anti-counterfeit technology is that there is no magic bullet. I think most experts realise that you have to have a kind of layered approach,” Duckworth added.
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STERILIZATION
VAPOR–
Juha Mattila, Steris Finn-Aqua, takes a look at safe material transfer of device components, and terminal sterilization of packaged products by using vaporized hydrogen peroxide
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aporized hydrogen peroxide (VHP) brings new possibilities for improvement by adding to the level of automatization and overall simplification of aseptic assembly and packaging process for sensitive drugs in prefilled syringe delivery devices, implants and other medical devices by VHP terminal surface sterilization. Material transfer of components to aseptic assembly and packaging can also be improved by using atmospheric VHP biodecontamination chambers for example instead of wiping surfaces of transfer bags and material airlock or hatch. The need for low temperature bio-decontamination Some key drivers for the growing interest towards VHP terminal surface sterilization technology are the following: • Increase in temperature - and radiationsensitive injectable drug products • Complex medical devices • Growing costs of aseptic assembly and packaging of such products • Sterilant residue concerns along with sensitive materials compatibility Over the past decade the number of in-house installations in aseptic packaging areas of pharmaceutical manufacturing facilities has grown steadily, and is projected to continue per continuously increasing amount of emerging sensitive injectable drug products and implants in the market (1). Hydrogen peroxide in vapor state, has been widely used in room, surface decontamination and device reprocessing applications for 30
years. In that time, Steris has been developing products and applications that have proven to be efficient for microbial inactivation. VHP applications include isolator workspaces, material transfer chambers and cleanroom biodecontamination and terminal sterilization of packaged products and medical devices.
components and VHP does not penetrate through material walls. However, VHP is not compliant with cellulose-based materials such as paper or cardboard. Therefore, final cardboard packaging of finished products cannot be applied prior to VHP sterilization of incoming production materials, but after.
Several scientific research papers over the past three decades prove vaporized hydrogen peroxide (VHP) to be very efficient for microbial inactivation (2). The sterilization or biodecontamination process is also relatively easy to adapt to manufacturing facilities. Implementation is facilitated by manufacturing capacity-sized, in-house units (from 500 liters to over 10,000 liters in chamber volumes), as well as the safe environmental properties of hydrogen peroxide, which yields the nontoxic byproducts of water and oxygen. Low temperature sterilization in this article refers to the Steris VHP terminal sterilization temperature range of +28…40 °C for sensitive drug products and materials. Material transfer processing by utilizing VHP for surfaces bio-decontamination, also occurs at local room temperature conditions, but can vary more than terminal sterilization temperature range, as sensitive drug is not yet present. Depending on type of equipment and application, VHP is generated from 35% or 59% pharmaceutical grade liquid hydrogen peroxide solution.
6-log reduction of bioburden is a typical efficacy requirement for material transfer loads using VHP atmospheric bio-decontamination, and SAL 10-6 for product is targeted for packaged product when utilizing the VHP terminal sterilization process. Aseptic filling of the drug is required for the drug in primary container for a pre-filled syringe / delivery device application.
Material compatibility of VHP is one significant advantage, as the range covers most plastic materials used in devices and secondary packaging, as well as glass, electronics, stainless steel and aluminum used in processing equipment. Material discoloration or strong oxidation effects are not typical for plastic
References: 1. Pre-filled syringes world market prospects 2012-2022 (Visiongain, UK, 2012) 2. VHPTM Technology: A Collection of Scientific Papers AMSCO Scientific, Apex, NC, USA, 1992)
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VHP atmospheric biodecontaminatioN VHP bio-decontamination is used in material transfer of pre-sterilized components to production, such as vial stopper bags, wrapped components and syringes. The cycle outcome is achieved in atmospheric conditions and ambient temperature. The three process phases in the cycle are pre-conditioning, VHP bio-decontamination exposure and post-conditioning. Pre-conditioning prepares the load for exposure to hydrogen peroxide vapor that destroys bioburden during the VHP decontamination phase. Post-conditioning phase is required to aerate the load and remove peroxide residuals from the load and chamber prior to unloading materials to production side. Cycle duration depends on load and configuration, but Steris’ experiences in industry applications indicate that it typically remains well below one hour in total cycle time.
–TRAIL VHP deep vacuum low temperature surface terminal sterilization
other sterilization methods may be in radiation sensitivity of material, or temperature sensitivity of material or electronics.
VHP low temperature surface terminal sterilization process requires a controlled environment, meaning control over pressure, temperature, water and hydrogen peroxide humidity control, and cycle time. The sterilization cycle is performed in deep vacuum conditions to achieve the controlled environment, and to ensure that complex device surfaces and possible diffusion-restricted pathways such as needles, receive exposure to VHP within the secondary packaging that utilizes Tyvek or equivalent layer, allowing penetration of VHP and water vapor in and out of the package. During VHP exposure dry and non-condensing vapor is generated by controlling the environment in maintaining peroxide vapor continuously slightly below saturation point.
Think about the design of your manufacturing process in good time before locking down the device, syringe or secondary packaging design.
A low temperature VHP terminal sterilization cycle consists of the following main phases: Preconditioning of the load and chamber (humidity removal and deep vacuum air removal), VHP exposure in deep vacuum conditions, and postconditioning to remove peroxide residuals, and equalization to atmosphere prior to unloading. Typical cycle times vary between two and four hours depending on load configuration and on the amount and type of plastic materials used in the package. VHP sterilization cycle is energy efficient, and therefore cost efficient. A typical cycle cost, depending on equipment and load size, varies between $18-38 (estimated by various size Steris VHP LTS-V processing units and cycles and their actual utility consumption measurement data). Typical products are single-packaged delivery devices with parenteral drugs such as biologicals, biosimilars or other sensitive products, eg with specific proteins that are sensitive to heat and radiation. Another typical application is a singlepackaged sensitive implant device that requires uncompromised sterility and low residual levels. Limitations for such devices when using
The drug and device product development process is lengthy and has many phases and factors that need to be considered for achieving the optimal outcome. There is potential to save time and cost when low temperature terminal sterilization is considered before the device design is completed and production line planning is started. Such devices are often assembled and packaged in aseptic cleanroom conditions and may only use low level or no automation in assembly, as it may require an isolator line or laminar cabinet, one by one. A terminal sterilizer at the end of the aseptic packaging line can give more freedom for the automation of device assembly and packaging after aseptic filling step, and enable work to be done in lower cleanroom classification levels such as grade C or D, instead of grade A or B. This is a cost saving potential for manufacturing facilities and a bottleneck preventer for production quantities. For high value and smaller batch products, the in-house terminal sterilization solution also saves time-to-market as the product does not need to be transported to a third party for further processing.
STERILIZATION
“Think about the design of your manufacturing process in good time�
Cycle development is the next phase but it occurs with the built unit for the application and usually is carried out with full load of the product in question. These are important steps, as they provide an excellent basis for the validation of production cycles, and therefore benefit the approval process. Chemical and biological indicators are used for product feasibility testing, cycle development, validation and batch control purposes. Equipment and process validation These equipment and applications are subject to cGMP and GAMP requirements for process components and control systems. Process validation often demands electronic data security with 21 CFR part 11 compliance. Process validation is performed individually for the terminal sterilizer per ISO 14937. Although no specific validation standard for VHP sterilization exists, the ISO 14937 standard does provide all required tools for defining the process validation to fulfill the requirements of the specific sterilization application from both regulatory and optimized process perspectives. CLEAN SWEEP: VHP low temperature sterilizer in terminal surface sterilization application
Feasibility testing is used to ensure device integrity and material compatibility for exposure to hydrogen peroxide as well as deep vacuum levels. The testing is carried out with a representative cycle that can kill challenge micro-organism in the hardest to reach locations of the device and package, as well as verify sufficient presence of VHP by using chemical indicators.
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INJECTION MOLDING
Made to work: Universal Robots has helped Dynamic Group lower labor content per part, and gave people better jobs
When the Cartesian robot drops the molded part down the slide, a proximity sensor alerts and activates the UR robot for pickup.
Automatic for the people Dynamic Group had difficulty staffing its injection molding production and wanted to better utilize its labor force. Three collaborative robot arms from Universal Robots have taken over repetitive tasks, improving product consistency and increasing production capacity
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ynamic Group, a Minnesota-based contract manufacturer, sought to automate repetitive manual tasks after finding employees to fill injection molding jobs proved challenging. As CEO Joe McGillivray puts it: “We’re lucky to live in a place that has high wages and low unemployment, which is great on a daily basis normally, but it’s difficult for someone who runs a business.” The collaborative robots are used in three different applications. The first robot tends a complete machine cycle; it picks and places ‘book frames’ that hold pieces to be molded into the injection molding machine, transports the units to a trimming fixture, places the part in front of an operator for further handling, and finally pushes a button to activate the cycle again. This application produces a medical device with parts that are extremely heat sensitive, so cycle times have to be consistent from part to part.
damaged parts, and the operator had to catch them before they unloaded. “It was very challenging for the operator to keep up, making sure the parts didn’t fall and trimming them as well, resulting in a lot of ruined parts. Now we still use one operator, but they can be there one quarter of the time they would otherwise,” explains McGillivray.
“We were having trouble making one good part with manual labor, let alone the various shifts tending the machine cycle differently,” says McGillivray.
Payback
“Universal Robots’ UR10 robot arm gave us a perfectly consistent cycle. We went from having three operators on a single shift to being able to run three shifts per day with just one operator per shift. So we essentially quadrupled our production capacity and our scrap went from significantly high to near zero. It’s been an extremely successful application for us.”
The third robot is deployed in a kitting application. Using a vacuum gripper the UR10 picks up a ‘clam shell’, the bottom part of a plastic box. It then places sterile wipes and saline solution into the clam shell, and pushes the loaded shell onto a conveyor. Before the UR10, Dynamic Group used six to seven employees at once to do this kit assembly application.
Hand off with cartesian robot The second injection molding application uses a traditional cartesian robot that drops a molded piece down a slide where the Universal Robot (UR) picks it up and places it in a degating fixture, then palletizes the part on a table in front of the operator for inspection. Previously, the parts would fall onto a conveyor, which often
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“It was fast paced and very high volume. It wasn’t sustainable. Now we’re able to run it with as little as two people. Having this type of success out of the gate as first time rookies at this stuff has been phenomenal and totally unexpected. Our return on investment was less than two months, and we can even go further because we’re able to adapt the robots to other products so quickly,” says the CEO.
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Taking a fresh look at counterfeiting in pharma and medical devices: from root causes to current solutions
WEBINAR Date: Thursday 14th September 2017 Time: 13:30 BST, 14:30 CET, 08:30 EDT, 18:00 IST Price: Free How do I know if my pharma and medical devices are being counterfeited? And how do I take swift countermeasures when it happens? As pharma companies have improved patients’ access to safe medicines, the value of pharma brands has grown. It is attracting not just investors, but also counterfeiters. The WHO estimates up to 8% of medical devices on the market are fakes, as are up to 30% of medicines. The rise of new technologies and more complex value chains have made fighting counterfeit medical products more challenging. Yet it is a priority for patient safety and brand reputation. Clariant, the global leader in speciality chemicals, and SICPA, a global provider of security solutions, have joined forces to bring protection closer to the medicine. In the process, they are helping healthcare companies re-think security for pharma products, including medical devices and pharma packaging. If you are in charge of your company’s brands or supply chain, come join us in this webinar. Among other topics, we will look at: Among other topics, we will: • Discuss the sources of counterfeiting • Explore the tools and technologies on the market and what they were designed to do • Examine the current landscape in terms of technologies Learning objectives: • Find out which tools are relevant in the market and how they are designed to achieve anti-counterfeiting • Discover where we stand in the fight against pharma fakes • Discuss why anti-counterfeiting should be embedded into your risk management
Medical Plastics News is the voice of the medical plastics industry. It is an essential source of business critical, highly relevant and unique intelligence, which stimulates thought leadership and nurtures an innovative and connected community of industry stakeholders.
Speakers: Mr Steve Duckworth, Head of Global Segment Medical & Pharma, BU Masterbatches, at Clariant Plastics & Coatings Ltd, is responsible for medical & pharma products Mr Yann Ischi, Director New Channels & Partnerships at SICPA, is responsible for security solutions for private-sector clients, including pharmaceuticals Mr Mark Davison, CEO of Blue Sphere Health, is an independent consultant and expert on both serialisation and anti-counterfeiting in the pharmaceutical industry Dr Marie-Lyn Hecht is a leading practitioner in the pharma & life science practice at Strategy&, based in Zurich. She is a principal with PwC Switzerland. With more than 10 years of pharmaceutical consulting and biomedical research experience, she brings a deep understanding of health care industry trends to her practice, which focuses on research and marketing strategies for pharmaceutical companies. She has diverse project-derived expertise in the area of anti-counterfeiting, serialisation and track and trace.
Register Now www.medicalplasticsnews.com/webinars Can’t make the date? Sign up any way and we will send you an on demand copy after the event.
SICPA is a trusted global provider of security inks as well as secured identification, traceability and authentication solutions. With high-technology security inks at the core of its expertise, the company protects the majority of the world’s banknotes, security and value documents, and a wide range of consumer and industrial products. It offers solutions and services to governments and industry, ensuring product authentication, traceability and protection as well as tax reconciliation.
As one of the world’s leading specialty chemical companies, Clariant contributes to value creation with innovative and sustainable solutions for customers from many industries. Our portfolio is designed to meet very specific needs with as much precision as possible. At the same time, our research and development is focused on addressing the key trends of our time.
INJECTION MOLDING
Robots on wheels It took Travis Oksendahl, automation engineer at Dynamic Group, about two days to get the robots programmed once the robotic cell was set up. The Minneapolis injection molder is able to quickly redeploy its UR robots to completely new tasks in short order. “All the robots are on bases that we can transport around on wheels and slide from press to press and application to application. The fact that we can quickly reprogram and redeploy these robots enables us to effectively address our high mix/low volume challenge,” said McGillivray.
molder who is now training employees to operate, install, and program the UR robots.
Future applications McGillivray and his team are also working on getting more UR robots into production. Next step will be installing the smaller UR3 model directly on presses. “The UR robots’ number of I/Os and the ease of access to them, makes this relatively simple to do. With quick tool changes we should be able to address our high mix low volume situation extremely well. We’re also looking to integrate a UR with a structured lighting system for doing micron level inspection 360 degrees around a part. That’s a capability we’re anxious to get in place.”
Having robots did not lead to staff layoffs
No safety cages needed The mobility of the UR robots is in stark contrast to traditional industrial robots that usually stay bolted down in a safety cage. They robots can work collaboratively right alongside Dynamic’s employees due to a built-in safety feature causing the robots to automatically stop operating when they encounter obstacles in their route.
The UR robots come with a palletizing feature pre-programmed that Dynamic Group used when the robot places the molded parts on the table in front of the operator. “It was really nice to have the pre-canned program, I only needed to teach the four corner positions and the robot automatically figured the remainder of the positions from there,” says Travis Oksendahl, Dynamic Group’s Automation Engineer.
“Our employees are working directly with the robot, there is no fence in between. That’s a huge savings to us on time, needing to manufacture, and costs to manufacture those enclosures and of course floor space. We’re able to fit a lot more automation in a much smaller footprint,” added McGillivray.
Tested robot on own body All three UR robot models (UR3, UR5 and UR10) utilize a patented technology to measure electrical current in the joints to determine force and movement. If the robot arm measures a force stronger than the amount it is programmed for (can be down to 50 Newton in UR3) it automatically stops. McGillivray wanted to understand how well the safety features worked on the system so asked for a program to be written that allowed him to walk in its way as it was going back and forth. “It didn’t hurt, sensed me immediately, and stopped just like I’d want it to,” he said.
No job killer Having robots take over tasks previously handled by employees did not lead to staff layoffs at Dynamic Group. “We needed to make better use of the labor we had on hand. Instead of using our employees as labor, we needed to use their brains. That’s what Universal Robots has helped us be able to do. We lowered our labor content per part, and gave people better jobs,” says the injection WWW.MEDICALPLASTICSNEWS.COM
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INJECTION MOLDING
GOING STATESIDE With a new cleanroom, UK-based Boddingtons is boosting its US profile
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njection molder Boddingtons anticipates increased sales and commercial activity in the US medtech sector, thanks to increasing demand for its modular Class 7 cleanroom. This was launched last November as part of the company’s £4.6m new factory investment.
Product line: Boddingtons can offer the ability to create finished components and shelf-ready medtech components
Managing director Andy Tibbs attended this year’s MD&M West, Anaheim California in February – indications then and subsequently have pointed to the Kent moulder increasing its profile within the US medtech market. “We have healthy existing USA sales already,” said Tibbs, “Through our partnership with ARC Medical and our work with Olympus. We see the potential for much much more,’ he adds. ‘We know the features of the US market very well. All of our manufacturing processes and procedures are FDA approved, and we have a long and successful track record in achieving 510 (k) clearances for our clients there.” Tibbs hinted that the timing is favorable for the company’s increased transatlantic activity and sales. “The current trading conditions seem very favourable in terms of the dollar-based purchaser. The current USA/UK political relationships – post Brexit – also seem to be ready to facilitate a renewal of trade between our two countries.” Tibbs added that, “in the right circumstances Boddingtons is able to consider local manufacturing and supply, most likely along the US Eastern Seaboard. We have a clear vision of what we are capable of and what the market
Trading places: The USA/UK relationship – post Brexit – seems to be ready to facilitate a renewal of trade between our two countries, says Boddingtons’ Andy Tibbs
needs and we are in a good position to take action.”
includes all FDA-related matters of 510 (k) approval.”
Boddingtons services for Class 1 and Class 2 device manufacturing are a key part of its brand new £4.6m molding facility, which, for the transatlantic buyer, is less than an hour’s drive from London’s Gatwick Airport.
The advanced molding environment at Boddingtons is designed for maximum flexible assembly and high-spec production, including the ability to create finished components and shelfready medtech components. The new facility also reduces bioburdens and particulates. New white rooms offer a minimum of contiminants and fibers. Disaster recovery safeguards and many other customer benefits have been built into the new buildings.
Since the new factory launch, business has been brisk. The Class 7 cleanrooms are now equipped with a total of eight molding machines, beside the press automation, in line printing and other technical services, all producing a great variety of medtech parts; from DNA trays to needle holders, endoscopy products, medical tubing and many other medtech devices. Boddingtons client services range from conceptual design, prototyping, tooling, automation and full manufacture together with the added benefit of the company having its own dedicated regulatory manager on site. Tibbs added: “We are happy to provide this regulatory help in order to support the generation of technical files, ensuring that all relevant documentation and registration with the correct governing bodies has been taken care of. This
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Boddingtons has won the Plastics Industry Awards (Industrial Design category) for three years in a row and two of the three winning designs were in the medtech field; the Braidlock device for use in emergency and battlefield situations and the colonoscopy. At the new factory launch Lord Digby Jones said that: “British manufacturing has a pearl of opportunity at this moment - and we should seize it.” Lord Jones also praised the Boddingtons team for its ‘amazing new manufacturing facilities’ and for the company’s forward thinking and strategic investments in plant, people and technology.
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CATHETERS
Design for life Ray Ledinsky, Teleflex Medical OEM, provides expertise on designing a catheter to achieve optimal performance
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n catheter design, the functional requirements of the application allow the designer to identify performance requirements such as flexibility, lubricity, kink resistance, column or push strength, and torque transfer characteristics. Development of an optimal catheter design requires a strong understanding of catheter technologies to achieve the desired performance characteristics. This article offers a layer-by-layer approach to several design considerations for your device. At its simplest form, a reinforced catheter design is composed of an inner liner layer, a central reinforcement layer, and an outer polymeric overlayer. Inner layer: Liners When selecting a liner material, it is essential to consider both the benefits of a material and its design considerations. There are tradeoffs with any material. The key is to understand what is critical for the catheter’s application. Here is a reference guide to selected liner materials. PTFE (polytetrafluoroethylene) Benefits: Best lubricity, lowest coefficient of friction of any fluoropolymer and thermoplastic Ideal for multi-durometer design Thin walls EtO and autoclave sterilization Design considerations: Requires manual assembly No Gamma or E-beam sterilisation Etching required FEP (fluorinated ethylene propylene) Benefits: Good lubricity Lower coefficient of friction compared to ETFE, HDPE, and Pebax More flexible than PTFE Single-durometer (continuous process) or multi-durometer Gamma, EtO, E-beam, and autoclave sterilisation Design considerations: Single durometer is most efficient when usin a continuous process Etching required
HDPE (high-density polyethylene) Benefits: Good lubricity Good adhesion Continuous process Gamma, EtO, E-beam, and autoclave sterilisation Design considerations: Not as lubricious as PTFE, FEP, or ETFE Only single- durometer is available when using a continuous process No etching require Adhesion is based on tie-layer technology Increased reinforcement options are possible POLYAMIDES/PEBAX Benefits: High material strength Good for thin-walled, high- pressure applications Single-durometer (continuous process) or multi-durometer Gamma, EtO, and autoclave sterilisation Design considerations: Only single-durometer is available when using a continuous process Can be manually assembled for multi-durometer process Central layer: Reinforcement There are two distinct types of catheter reinforcement: braid and coil. Advanced partners should be able to offer you technologies for increasing the tensile yield of a reinforced catheter. These include the incorporation of longitudinal, reinforcing components in a variety of materials such as flexible, high-tensile, advanced fibres. Braid reinforcement
ETFE (ethylene tetrafluoroethylene) Benefits: Superior tensile strength and stiffness Higher lubricity as compared to HDPE and Pebax Single-durometer (continuous process) or multi-durometer Excellent impact resistance Gamma, EtO, E-beam, and autoclave sterilisation
Excellent torque control is the primary driver of a braided catheter design. This can be achieved with braid reinforcement. Manipulation of the distal tip of a catheter, by twisting the proximal end, requires good torque transmission with little ‘whip’. A relatively linear response is a desired catheter characteristic for end-use applications.
Design considerations: Only single - durometer is available when using a continuous process Etching required
The wire size, profile, density (PPI), and braid configurations can be engineered to provide a great balance of pushability with good torque control. In some cases, multiple braid layers are necessary to meet the level of manipulation that is required.
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CATHETERS The pitch of the braid pattern can also be modified, by section along the length of the catheter, to vary both the catheter flexibility and hoop strength. Materials used in the reinforcement can be metallic or non-metallic. As for metallics, the most popular is stainless steel. Nitinol, due to its kink resistance, is becoming popular in microcatheters. There are three common braid patterns typically used in catheters. Each pattern produces different levels of torque and kink resistance. Regular braid pattern is a common pattern that uses 16 wires in a one-under-two, over-two pattern. Diamond braid pattern also uses 16 wires but differs from the regular braid pattern in that it produces a two-under-two, over-two wire pattern. This pattern tends to provide better torque and more kink resistance than the regular braid pattern but also has a slightly higher cost. Diamond braid pattern, half load: By utilising half the number of wires, the diamond pattern can be produced in a one-under-one, over-one wire pattern. This pattern provides more torque than the regular diamond pattern but incurs a much higher cost due to the reduced wire load. Device designers are not limited to these three basic patterns. Several original equipment manufacturers can create customengineered braid and coiling variations. Now it is even possible to utilise variable pitch, continuous reinforcement that can vary performance characteristics along the length of the shaft. Also, there are novel technologies for connecting dissimilar sections of the shaft without sacrificing shaft flexibility or performance. Designers can create precise catheter characteristics by combining any number of diameters, reinforcements, and hardnesses. Coil reinforcement Outstanding hoop strength, kink resistance, and good pushability are characteristics of coil reinforcement. Teleflex Medical OEM can provide discreet, coilreinforced catheters, on a PTFE liner, using a laidup assembly process. This is generally limited to a single pitch along the length of the catheter. A recent technology is continuous, coilreinforced assembly that allows the coil pitch to be varied along the length (variable pitch coiling). This allows differing amounts of flexibility and kink-resistance along the catheter shaft. A continuous-coil design, using an HDPE liner, is one of the most cost-effective, composite designs available for a catheter. Often there are trade offs required in the catheter design depending on the performance requirements. For example, higher torque can be achieved with a higher pick count* but this will reduce the flexibility of the shaft. Likewise, a larger diameter braid wire can be specified to provide more stiffness and torque, but this will impact the minimum wall thickness and flexibility. A flat braid wire will reduce the wall and increase the flexibility, but this will also reduce the torque. As a result, it is important when designing a reinforced catheter shaft to consider the performance requirements up front to assure that the design meets the needs of the user.
Outer layer – polymeric overlayers This selection of the outer layer material strongly influences tensile yield, stiffness, and catheter pushability. The outer layer may be multiple materials or durometers. To perform effectively, a reinforced shaft needs strong adhesion between the inner and outer layers. Delamination between these two layers can compromise the catheter’s functional performance. This limits the choice of outer layer materials to polar materials, because they can adhere directly to either an etched surface or a tie layer. Polar materials are also beneficial for adding a hydrophilic coating on the outer layer, as they provide better adhesion. Lubricity and durability are the key requirements for consistent performance from a hydrophilic coating. Lubricity provides for ease of device insertion and tracking to the treatment site while simultaneously reducing damage to the endothelial layer of the vasculature. The coating’s durability properties are critical to meet the reliability demands of modern catheter appl ications. More construction elements for consideration We’ve examined the three, basic components of catheter design. By incorporating a variety of construction elements, manufacturers can create catheter shafts with unique features. A steerable catheter shaft can be produced with multiple steerable wires, enabling clinicians to maneuver the tip precisely in multiple directions. Clinicians must be able to position the tip in the right place so that they can deploy the device properly. Multi-durometer segments along the shaft and tip, with varying degrees of softness or hardness, can alter the catheter’s flexibility, bend radius, and deflection angles. Balloons, with thin walls and small profiles, can be added to the shaft tip to create innovative catheter dilation and delivery systems. Marker bands of high density precious metals—typically tantalum, gold, or platinum — can be positioned along the shaft and used as a guide to distinguish key areas along the length of the catheter. Flexible radiopaque markers are sometimes used in lieu of metal marker bands. Encapsulated with tungsten-filled Pebax®, these markers provide similar radiographic visibility, while being soft and pliable. A plethora of decisions go into producing high-performance catheters. At each step of the process, these decisions can positively or negatively impact the overall function of the device. In addition, taking a concept from a functional prototype to a marketable catheter requires in-house expertise, and superior design and manufacturing capabilities. Finding the right partner that can deliver along those attributes can go a long way toward a successful product launch.
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* The pick count is expressed in picks per inch of length (PPI), which represents the number of times the wire crosses for every inch of shaft length. The higher the PPI, the more wire coverage is achieved.
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Xianbo Hu Ph.D., Principle Scientist “I am inspired to solve technical challenges, providing innovative solutions sets Vancive apart.”
Inspiration. Innovation. Dedication. Advanced Medical Adhesive Applications that Touch Lives With a relentless dedication to what’s next, the people within Vancive’s Core Business Segments see future possibilities. Offering scalable and inspired solutions for OEMs and Converters, Vancive Medical Technologies® responds to the unique needs and changing requirements of our customers. Dedicated professionals such as Xianbo Hu are agile, forward thinking, open to new ideas, and have a vision that helps customers and partners succeed. Download the Vancive™ Product Finder App Available on the App Store® and Google Play™
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CATHETERS
Exact science Conair’s Bob Bessemer explains how to make better and more precise micropore extrusions and how improvements in downstream extrusion control make catheter production more predictable
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hen it comes to production of medical plastic tubing for catheters and stents, it is not only desirable, but essential to predictably control every factor in the extrusion process. The increasingly sophisticated uses of microbore tubing in medical applications demands that processors exercise the highest possible control over all key characteristics – quality, precision, repeatability, traceability, cleanliness, and more. Processors must do so while facing a significant list of production challenges: microbore tubing sizes (less than 0.060 in diameter) for heart and brain catheters; multilumen structures for diagnostic, interventional, and therapeutic uses; increasingly complex bump profiles; and ever tighter tolerances for factors including inside diameter (ID), outside diameter (OD), concentricity, and elongation/burst strength. Years of dedicated, customer development efforts by extrusion equipment makers like Conair have resulted in a steady stream of improvements that make production of medical plastic tubing more predictable and controllable than ever before. Medical plastics processors are looking for improved precision and reduction of process variability. They know
that repeatable extrusion starts well upstream with factors like material selection, blending, plastication, and die temperature and pressure control. However, recent and less-well-known downstream improvements are likely to hold the key to reaching the next level of extrusion process control. For example:
tank, generates final ‘cold’ OD dimensional data. Together, the information from these gauges can be used to help adjust puller speed and vacuum – essential for maintaining critical dimensions – while a vision system detects gels and surface imperfections, enabling automatic identification of ‘bad’ tubes down the line.
Vacuum sizing
Temperature controlled cooling
Instead of relying on free extrusion that uses air – a compressible and therefore variable medium – vacuum sizing offers a more dependable way to control extrusion profile and roundness, including the size and shape of individual lumen. Conair’s MedVac vacuum sizing/ cooling tanks, for example, draw vacuum on the tank, creating a differential pressure and preventing cooling water from drooling out the orifice through which the tube enters the tank. This prevents potential negative effects on the concentricity and surface finish of the tube. This differential pressure environment, applied over the entire immersed length of the vacuum chamber, enables a more predictable and controlled sizing as cooling takes place. During the cooling/sizing process, an ultrasonic gauge in the tank can be used to monitor wall thickness and ‘hot’ OD, while an OD laser gauge, positioned downstream from the
Water is the medium used to transfer heat so that the tubing can solidify, but simply making that water colder is not always the best approach. In some applications, cooling too fast can adversely affect the quality of the finished tube, so temperature-control units need to be used to maintain optimal rates of heat transfer and preserve material properties. For applications in environmentally regulated spaces (cleanrooms and white rooms, for example), water-cooled condensers are the preferred choice, since they operate without air-circulation fans that can blow contaminants within the space.
Pullers and cutters
tube extrusion line: pullers and cutters. Servo controls enable pullers to respond more precisely to process feedback to adjust and maintain speeds in very fine increments. Cutters have also advanced in important ways, all of which are essential to improved automation. They also improve dimensional precision, cutting even microbore tube sizes (down to 0.008 in) while maintaining cutto-length tolerances of ± 0.015 in or better with specialized input devices. Conair’s MedLine micro planetary cutter, for instance, use a spinning blade to make lathelike cuts on even brittle, shatterprone tubing materials without deformation or particulate generation—something more conventional fly-knife cutters cannot do. With inputs from inline gauges and vision systems, imperfect sections can be cut out and discarded automatically.
Cleanroom ready equipment None
of
these
process
innovations canexplains help if you can’t Conair’s xxx how to employ them, right away, in a make better and more precise The addition of servo-drives, medical production environment extrusions or andwhite how with servo-rated low-backlash micropore like a cleanroom reducers, together with closed- improvements room. That is in whydownstream Conair has loop feedback control, have developed MedLine, a complete extrusion control make catheter dramatically improved the offering of over 40 predictable models with production more precision and controllability of the final components of a medical
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170 variations of cleanroomready auxiliaries.
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T
r D o th e
Bob Donohue, Natvar, a Tekni-Plex company, explains how the latest generation of microextrusion medical tubing opens doors to new procedures
echnological developments mean that the definition of what constitutes microextrusion medical tubing has shifted. As a result, both medical device manufacturers and patients stand to benefit.
Typically, extrusions were designed to assist with procedures from ‘the neck to the knee’. Tubing manufacturers could not extrude with tight enough tolerances to access the smallest arteries found in the head or below the knee. That meant certain life-sustaining, neurovascular interventional therapies and surgical procedures were often difficult.
ou
What was once called a microextrusion—typically a 0.015 inner diameter (ID) x .055 outer diameter (OD)—is now considered a standard extrusion. What used to be outlier dimensions are now considered common. In the past, these micro tubes were produced out of glass or, in the case of fluoropolymers, involved a secondary stretching operation to achieve the desired ID and OD. With minimally-invasive surgery becoming the future, microextrusion tubing can now help OEMs develop complex devices that can provide therapies and treatments not previously possible for hard-to-access extremities.
Unrealistic requests become reality The development of new technology is driven by need. Medical device manufacturers pushed the envelope by asking suppliers to develop tubing with tighter tolerances that were significantly outside the norm. What was initially considered an unrealistic expectation for the plastic extrusion process turned into a reality as technological inroads on the processing side were made. Today’s new microextrusion definition is an ID size in the 35 microns (or 0.0014 inch) range, with very thin walls and extremely tight tolerances to meet the needs of newer invasive applications. Now that extrusion technology (both process and equipment) has caught up with the needs of the medical device industry, the latest microextrusion tubing can be made in a one-step process from less expensive materials. The latest die designs, pressure transducers and high-end, inline, closed-loop controls, are some of the breakthroughs that have contributed to the development of thermoplastic microextrusion tubing. Consistently achieved tight tolerances are allowing manufacturers to deliver performance attributes that were previously out of reach.
TUBING
nd s
It is also important to point out that multilayer microextrusions in catheter applications is another driver behind these developments. Being able to use microextrusion technology in combination with coextrusion technology adds many options for OEMs. This can allow for a highly lubricious inner surface (for device insertion), along with steerable characteristics, by modifying the outer shell of the catheter. This technology allows for the use of radio opaque indicators to be incorporated into the design without affecting performance.
New possibilities Natvar has invested in a manufacturing facility to produce the latest microextrusion tubing. Available are monolayer, coextruded (up to four layers), multi-lumen tubing or profiles in a variety of thermoplastic (PVC, urethanes, TPEs) materials at CPK values above 2.0. (The CPK value indicates how close a process is running to its specification limits, relative to the natural variability of the process. The higher the index, the less likely it is that any item will be outside the specifications. As a frame of reference, a CPK of 1.33 or better is what medical device companies typically require.) Natvar’s new microextrusion tubing comes in wall thicknesses ranging from 0.003 to 0.005 inches.
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MEDICAL DEVICE
Solutions
Lubrizol LifeSciences is your medical device solution partner. We provide support from idea to execution. How we do it: • Polymers: comprehensive, customizable, application-specific medical grade materials • Formulation: advanced drug delivery solutions, including drug-eluting devices • Manufacturing: contract manufacturing for medical device and components To learn more, visit www.lubrizol.com/lifesciences
© 2017 The Lubrizol Corporation, all rights reserved. All marks are the property of The Lubrizol Corporation. ™ The Lubrizol Corporation is a Berkshire Hathaway company. 17-81447
Links Science to Life
TUBING
Cost profile
Speed to market
The ability to create microextrusion tubing from thermoplastics means that medical device companies can reach desired performance attributes at a fraction of the cost associated with fluoropolymers and glass.
To help OEMs meet commercialisation objectives, it’s important to partner with a supplier that can assist in getting validations correct on the first try. For many years, medical device manufacturers have had to modify their manufacturing process to accommodate out of spec tubing. This resulted in a less-than-efficient process which frequently had a negative impact on speed-to-market objectives. It’s important both for device functionality and production efficiency to work with tubing that consistently delivers tight tolerances.
Multi-channel (or multi-lumen microcatheters) can aid cost reduction by incorporating more than one device in a single structure. As microextrusions are being developed and enhanced, so are the devices that are used in conjunction with these structures. Fiber optics, guide wires, sensors and stents are examples that up until now were limited by size due to the lack of extrusion capability needed to make them.
Patient care It is also important not to overlook the psychological aspects of patient care. Advances in medical devices and therapies supported by microextruded tubing can go a long way in potentially enhancing the patient’s comfort level and recovery time. Discomfort and recovery can be minimised if procedures are less invasive and more therapeutic.
Performance and production impact The ability to consistently manufacture microextrusion tubing in tight tolerances impacts device production, and patient satisfaction. Catheters, for example, are typically tip-formed and punched. When there are wide tolerance variances, the consumer experience will not be consistent each time he or she needs to catheterise themselves. One catheter tip may be painful upon insertion, while the next one might not be. Lack of consistency can result in consumer discomfort and stress in not knowing what the next usage experience will bring. There are other applications where precise delivery is required, where tight tolerances also can have a positive impact. An example is a tube used for wound therapy. Medication needs to be precisely administered to the wound area. Traditionally, liquid has been pushed through the tube to see how much volume was coming out. The tube would then be cut to get to the approximate correct volume. This less-than-precise way of delivering medication was the workaround used to compensate for an ID that was not in tight tolerance. Conversely, when the tube consistently delivers tight tolerances throughout its production run, guesswork can be eliminated. It also benefits the device manufacturer by enabling higher throughput.
Global supply capability An international supply pipeline can be critical. Not only should OEMs consider the supplier’s capabilities, but they should take a good look at their global manufacturing footprint. Medical device manufacturers want access to exactly the same components and materials regardless of where in the world their manufacturing facility is located.
Potential applications Potential applications for the latest microextrusion tubing are extensive and include both implantable devices and minimallyinvasive procedures. Possibilities include: Heart leads Connecting a pacemaker to the heart muscles. Neurological Treatments for stroke patients where micro stents need to be inserted into the vascular system to open capillaries to eliminate blockage. Vascular Below the knee procedures such as arterial drills to assist in blood flow below the knee that has been compromised by diabetes. Catheters Traditionally, heart catheterisation procedures use the femoral artery in the leg to access the body. Microextrusions would enable smaller devices to enter the brachial artery and aid in expanding smaller vessels that have potential blockage. With the capability to get into the smaller veins, as well as the larger ones, more of the heart is accessible. In vitro fertilization. The new microextrusion technology can assist with a critical step of the in vitro fertilization process that enables the nucleus of the egg to be harvested more precisely. Infant/pediatric care The effectiveness of miniature devices, such as microcatheters that are engineered for the youngest among us, can also benefit from microextrusion tubing.
WWW.MEDICALPLASTICSNEWS.COM
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Got the bug? Lawrence Acquarulo, Foster Corporation, looks in detail at antimicrobial masterbatches for medical plastics Hospital Infections According to a survey by the Center for Disease Control (CDC), 4% of inpatients in US acute care hospitals contract at least one healthcare associated infection. Device associated infections accounted for one in every four. In-dwelling devices, such as central venous (CV) catheters, are particularly susceptible to bacteria colonization which can enter the blood stream. Increasingly, medical device companies are evaluating antimicrobial additives for plastics used for susceptible devices. The resulting compounds are designed to kill harmful bacteria on the surface of device components.
Antimicrobial metals Silver and copper have been used for thousands of years to prevent microbial infections. Yet the mechanism of action was not fully understood until recently. This began in the 19th century, when scientists discovered bacterial microorganisms caused infections. In recent years, scientists have discovered how certain metals destroy harmful microorganisms, including methicillin-resistant staphylococcus aureus (MRSA) and carbapenem-resistant enterobacteriaceae (CRE). Metallic silver (Ag) is inert, insoluble in water, and unable to kill bacteria. However, when combined with certain elements (eg, chlorine) silver atoms lose an electron and become ionic (Ag+). This form of silver is colorless, water
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soluble, and highly reactive with other elements. Ionic silver attacks bacterial cell membranes making them more permeable. It also interferes with cell metabolism resulting in overproduction of reactive oxygen compounds that are toxic to the cells. Copper is an important nutrient for cells, including bacteria. However, in high doses it is known to efficiently kill bacterial cells. Research into copper’s precise antimicrobial mechanism of action is ongoing and inconclusive. Yet a number of studies indicate that copper effects the integrity of the bacterial cell wall and inappropriately binds to proteins within the cell causing loss of function. When used for infection control applications, these metals are often bound to inert carriers that impart chemical stability and extend the duration of antimicrobial action. Common organic carriers include zeolites, phosphates, titanium dioxide, montmorillonite and mesoporous silica. Zeolites are particularly effective carriers for melt blending with medical plastics. These crystalline aluminosilicates are compositions of aluminum, silicon and oxygen, with uniform cavities and pores. This geometric construction controls release of the antimicrobial metals. Importantly, zeolites can withstand the high melt processing temperatures of thermoplastics. Sciessent, a leading antimicrobial additives,
manufacturer of has developed
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technology that incorporates both ionic silver and copper in a zeolite carrier. Marketed under the brand name Agion, this technology is designed to exchange silver ions with positive ions from moisture in the environment. The exchange releases antimicrobial elements only when conditions are ideal for bacterial growth. The company reports Agion antimicrobial technology fights bacterial growth in three ways: it prevents respiration by inhibiting transport functions in the cell wall; it inhibits cell division and therefore limits the reproduction necessary for bacteria to colonize; and, disrupts cell metabolism.
Masterbatches for medical polymers Foster Corporation has developed high concentration masterbatch formulations using Sciessent Agion technology in a universal polymer matrix. These were developed to be dry blended with unmodified polymers at letdown percentages from 2-10%, depending on the polymer and application. Dry blending with masterbatches allows engineers to cost effectively evaluate different antimicrobial loading levels in medical components. Fosterâ&#x20AC;&#x2122;s Combat AD masterbatch was developed using Agion AD85H-M (AD) antimicrobial additive; a fine particle zeolite (< 4 Âľm) and high proportioned ionic silver (20-24%). The masterbatch consists of 40% Agion AD and 60% ethylene vinyl acetate (EVA) - based
ANTIMICROBIALS universal polymer alloy carrier. Combat AD is designed to be used in TPUâ&#x20AC;&#x2122;s and silicones for indwelling devices such as CV catheters. Combat AK master batch was developed using Agion LGK-10 (AK) antimicrobial additive; a large particle zeolite (> 6 Âľm) and a low proportioned ionic silver (4-6%). The masterbatch consists of 40% Agion AK and 60% EVA-based universal polymer alloy carrier. Combat AK is designed for ABS and PC polymers used for high-touch surface components and devices. These include bedrails, diagnostic equipment housings and instrument handles.
In-dwelling devices, such as central venous (CV) catheters, are particularly susceptible to bacteria colonization which can enter the blood stream
Foster and Sciessent recently completed a joint study to determine the efficacy of these masterbatches. A total of six formulations consisting of different Agion additive loadings in three polymers. The percentage of Agion antimicrobial additive indicated below represents the total amount in the final blend. 1. TPU + Combat AD4 master batch (4% Agion AD) 2. TPU + Combat AD8 master batch (8% Agion AD) 3. ABS + Combat AK1 master batch (1% Agion AK) 4. ABS + Combat AK3 master batch (3% Agion AK) 5. PC + Combat AK1 master batch (1% Agion AK) 6. PC + Combat AK3 master batch (3% Agion AK) Antimicrobial properties of the TPU samples were tested according to ASTM E2149. Properties of the ABS and PC samples were tested according to ASTM E2180. These tests determine the kill rates of MRSA and CRE. For all six samples there was a 99.9999% microbial reduction, with log reductions between 6.4 and 6.8.
New options for medical products Certain metals, such as silver and copper, have a long history of reducing infections. Plastic components made from formulations that incorporate these antimicrobial metals can reduce hospital infections related to medical devices. Traditionally, material suppliers melt blended these antimicrobial additives into plastics prior to processing. However, engineers evaluating multiple additive loading levels had to invest in several compounds for molding or extrusion trials. An alternative approach uses master batches with high concentrations of metallic-based antimicrobial additives for dry blending with polymers immediately prior to molding or extrusion. This approach allows engineers to economically evaluate various antimicrobial loadings in the finished part using a single master batch. Recent tests confirmed effective microbial reduction using different master batch loadings in several common medical device polymers. WWW.MEDICALPLASTICSNEWS.COM
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Have you heard?
W
‘EARABLE’ SENSOR TRACKS CORE TEMPERATURE
ireless, wearable sensors have been a bit hit in the fitness world. These devices can count footsteps, monitor heart rate and other vital signs. Researchers report in the journal ACS Sensors that they have developed a 3D printed sensor worn on the ear that measures one of the most basic medical indicators of health in real time: core body temperature. Current wearable sensors can detect skin temperature, but this can change depending on how hot or cold an environment is. And
Unbreak my heart: Silicone heart could aid cardiovascular patients
W
e’re not short of 3D printing news on MPN but this one really stood out. Researchers from ETH Zurich have developed a silicone heart that apparently resembles a human heart. This completely soft artificial heart, mimics the human organ. It has a right and left ventricle but unlike a human heart, the two ventricles aren’t separated by a septum. Instead, an additional chamber is used which pumps fluid from the chambers by using pressurised air. Given that cardio vascular disease is the number one cause of death globally, this is an exciting development. Artificial hearts can extend a patient’s life until
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a donor heart becomes available, or their own heart recovers. It’s not all good news though – while the silicone heart works in a similar way to a human heart it has flaw; it only lasts for around 45 minutes, or 3,000 beats, until the material starts to break apart.
oral and other thermometers that measure core body temperature are designed only for periodic use and aren’t meant to be strapped on for constant detection. So Ali Javey and colleagues set out to develop a convenient device to monitor core body temperature in real time on a continuous basis. The researchers integrated data processing circuits, a wireless module and an infrared sensor, which detects ear (and thus core body) temperature, in a 3D printed device. The disk-like structure covers the ear and can
Nano polymer may cut heart failure Physics.org has reported that the development of a new nano polymer by researchers at BenGurion University (BGU) and the Sheba Medical Center, could prevent heart failure. Apparently the new biomedical polymer could cut arterial plaque and inflammation in the cardiovascular system, and is said to boast a range of benefits such as only targeting damaged, not healthy tissue. It is also said to have no side effects.
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be customized to fit the contours of a person’s ear for a comfortable fit. To ensure that users can still hear clearly while wearing the device, the researchers embedded a microphone to capture and transmit outside sounds to the inner ear. And the Bluetooth module transmits temperature measurements to a custom smartphone app. Testing showed that the “earable” sensor measurements closely matched those of a commercial ear thermometer. Credit: American Chemical Society
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