MEDICAL PLASTICS news
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Digital health – what you need to know Innovation in polymers Medtech at the movies
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...that mean a lot
Accumold looks at the role of micro moulding IN THE NEXT GENERATION OF DEVICE DESIGN
ISSUE 30
May - June 2016
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CONTENTS May - June 2016, Issue 30
Regulars
Features
5 Comment 7 News analysis How refusing supplementary protection certificates could restrict medical device investment 8 Digital spy 10 News profile Kevin Grygiel, Prisym ID, looks at labelling compliance 14 News analysis Why is 2016 the year for medical 3D printing? Cyient explains 19 Q&A 20 Cover Story Accumold has big things to say about micro moulding 42 Medtech at the movies
23 The patch test Deepak Prakash, Vancive Medical Technologies, says wearable medical technology is opening new healthcare frontiers 26 Liquid assets Graco says that successful manufacturing depends on getting the best from injection moulding equipment 29 At the front line Clever and futuristic new diagnostic tools fight some of our biggest global healthcare challenges, says MPN’s David Gray 30 Insider knowledge The University of Nottingham looks at the ways in which polymers and biopolymers can be used in medical contexts
32 Stick with it How silicone pressure sensitive adhesives are helping to meet the challenges of medical device adherence 34 Choice words Teknor Apex Company examines how many factors determine the best alternative to DEHP for PVC medical devices 36 Team spirit How robots have proved successful at GE Healthcare 38 Joint forces LPKF explains the benefits of laser plastic welding 41 An apple a day What this year’s MD&M East has to offer…
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CREDITS group editor | lu rahman deputy group editor| dave gray
EDITOR’S
comment
editorial assisstant | emily hughes advertising | laura seymour art | sam hamlyn publisher | duncan wood
Medical Plastics News is available on free subscription to readers qualifying under the publisher’s terms of control. Those outside the criteria may subscribe at the following annual rates: UK: £80 Europe and rest of the world: £115 subscription enquiries to subscriptions@rapidnews.com
Medical Plastics News is published by: Rapid Life Sciences Ltd, Carlton House, Sandpiper Way, Chester Business Park, Chester, CH4 9QE T: +44(0)1244 680222 F: +44(0)1244 671074 © 2016 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.
SIMPLY AMAZING Of course I’m biased as every issue of MPN is packed with great content. However, this issue really stands out for me. The medical plastic sector is vibrant and busy and I know the whole team feels fortunate to share the news and innovation from our growing community. It’s that time of year – we’re well into the cycle of exhibitions – when the industry really does seem packed to the gills with exciting events and breakthroughs. Working on a magazine called Medical Plastics News does raise a giggle or two among my friends. But every now and then I get to have the last laugh. Living in one of the UK’s cosmetic surgery hotspots it’s not unusual to turn up at the school gates to see a parent (male and female) sporting a new-look nose etc. When I get to reveal the latest breakthroughs hitting that section of the market, it’s amazing how I become flavour of the month. As news of the polymer that may one day be
used to hide bags under the eyes and wrinkles hit the headlines, it created a huge talking point for many people I know. Of course, it’s just the tip of the iceberg where innovation is concerned and I take immense pleasure being able to share the leading edge in polymer development with an audience that wishes it could try those technologies first-hand. Seeing the end results of medical plastics is rewarding. While the cosmetic market is of interest to a specific section of society, stories such as the news that scientists at Reading University have developed a polymer material that can repair itself at room temperature has much wider appeal. This material is a supramolecular polyurethane which is said to flow in a liquidlike way when it is cut or scraped but binds together again hours later to become solid again. It’s yet another amazing development but liked I said, I’m biased…
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It’s that time of year – we’re well into the cycle of exhibitions – when the industry really does seem packed to the gills with exciting events and breakthroughs.
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NEWS ANALYSIS
Refusing supplementary protection certificates could restrict medical device investment
“The long and short is we went long and got shorted.”
Copyright: Cartoonresource
T
he German Federal Patent Court (BPatG) recently declined an application by a medical device innovator for a supplementary protection certificate (SPC).
A recent German court ruling reinforces a precedent for medical device manufacturers that could result in weakened investment and less innovation in the sector. David Gray writes
SPCs are granted in the EU, typically in the life science sector, for medicinal products which are likely to require a long time in the market approvals process. They allow the patent term to be extended by up to five years, making investment a more attractive prospect. The device in question, referred to as “aminosilane-coated iron oxide nanoparticles”, is an innovation from the LeibnizInstitut für Neue Materialien Gemeinnützige.
Iron oxide nanoparticles can be used to target and kill solid tumours in the prostate and brain, according to research in clinical trials. Ultrasound is used to guide them towards the target site, and magnetic fields are applied to generate heat, which is the mechanism that enables them to destroy or weaken the tumour. Lexology, a news feed for the legal sector, recently published a blog by Jonathan Myers, associate patent attorney at IP law firm Barker Brettell on the ruling. Myers explains in his blog that the German Patent and Trademark Office rejected the original SPC application on the grounds that the product is a medical device, rather than a medicinal product. SPCs are typically granted to pharmaceuticals or products with a pharmacological action. The Leibniz Institute appealed against the decision. According to The SPC Blog (a blog dedicated to issues surrounding SPC rulings), Leibniz acknowledged that in one sense the product is a medical device as it is administered by a physical means. On the other hand, it argued that it could be classed as a medicinal product, as it is “administered in view to restoring or improving physiological functions in humans”.
The institute also argued over semantic fields. One of the regulatory criteria involved in the application for SPCs for medicinal products mentions active ingredients. The institute raised the argument that the term ‘active ingredient’ hasn’t been defined as being limited to products with a pharmacological action. Ultimately, the BPatG rejected the appeal, citing a previous, separate ruling from the European Court of Justice, that, in the court’s opinion, clarified that the term ‘active ingredient’ refers only to “substances producing a pharmacological, immunological or metabolic action of their own”, as Myers writes in his blog. So what does this case mean for medical device manufacturers? Myers writes: “Patent term extensions for such medical devices will likely only become available if new laws are drawn up, driven by a desire to recognise the regulatory burden that a medical device must go through for market approval.” But there is good news, he says. He cites reports that allege the EU may be considering measures that could help broaden the use of SPCs. The Leibniz case is just one of many such failed attempts to acquire an SPC for a medical device. In 2009 a case brought before the UK Intellectual Property Office involved a stent using the drug paclitaxel to prevent restenosis (a condition where arteries or valves narrow after corrective surgery). Despite the inclusion of a drug in this device, the SPC was not granted. This is perhaps a better example of a grey area in the semantics of SPC rulings. With drugs companies increasingly engaging medical device firms for innovative new delivery methods, the distinction between ‘medical device’ and ‘medicinal product’ is less and less clear. What do cases like this mean for investment? The real function of an SPC is to make a medicinal product more attractive to investors, as they can compensate for the risks associated with long times to market. So for investors, the already labourious and time-consuming regulatory approvals process could be enough to deplete the appetite for innovation.
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DIGITAL
spy
SILICON NITRIDE PLUS ROBOCASTING EQUALS A NEW APPROACH TO MEDICAL APPLICATIONS
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medica has made its first complex, threedimensional structures by a 3D printing process called robotic deposition, or robocasting. Robocasting is a freeform fabrication technique for dense ceramics and composites that is based on layered deposition of highly colloidal slurries. Amedica develops and commercialises silicon nitride ceramics as a biomaterial platform. The final products have been examined under scanning electron microscopy to confirm the integrity and validity of the 3D printing method and according to the company, have been shown to achieve similar theoretical density and microstructure attributes to the traditionally manufactured silicon nitride fusion devices currently in use.
Space race: NASA inspires a surgical device DEVICE UPDATE
A
NASA-inspired plasma pen is looking to revolutionise cosmetic and aesthetic surgery. Designed by Triteq for Fourth State Medicine, the pen aims to transform surgical procedures into non-invasive treatments. Gas plasma sterilisation isn’t new to the healthcare sector. However, this plasma pen uses a new concept, combining the different mechanics of plasma to achieve a better therapeutic effect. Plasma technology renders skin treatment in a non-invasive way and helps to dramatically reduce scars. It also helps to improve wound healing without the risk of infection or the
need for drugs in a range of cases, such as diabetic ulcers and bed sores. With over 50,000 people in the UK undergoing cosmetic surgery every year, the possibilities of using this revolutionary technology are endless, says its maker. Dr Thomas Frame, founder of Fourth State Medicine, said: “We will be a world leading technology provider and developer of solutions based on our revolutionary proprietary plasma based platform technology. This will offer new treatments, therapies and solutions responding to the demands and needs of our customers in well-defined and growing markets in the cosmetic, wound care, food, veterinary and sterilisation sectors.”
TECHNOLOGY UPDATE “This innovation speaks to the unique art and science related to our manufacturing strength,” said Dr Sonny Bal, chairman and chief executive Officer. “3D printing of a complex ceramic material opens future doors, especially in terms of cost advantages, and addressing a variety of OEM partner needs. Custom additive manufacturing is a modern advancement, and we are proud to lead the way in 3D printing of our silicon nitride formulation, with its advantages in bone fusion, antibacterial behaviour and superior strength.” Robocasting is a freeform fabrication technique for dense ceramics and composites that is based on layered deposition of highly colloidal slurries. The process is essentially binder-less and a device can be completely sintered in less than 24 hours. With this advancement, Amedica can now progress toward commercialising 3D printed silicon nitride implants, with controllable porosity levels to address specific clinical needs. This manufacturing method is promising for the production of anatomically relevant shaped silicon nitride implants, while also allowing custom fabrication of bone scaffolds suited for cellular differentiation and neovascularisation.
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SARTORIUS GIVES NEW MATERIAL HANDLING SYSTEM THE THUMBS UP
T
he installation of a Summit Systems’ material handling system has proved successful at Sartorius’ Gloucester facility. The project was delivered for the lab and biopharma e q u i p m e n t manufacturer to a tight time frame without interrupting production. The system moves pellets from wheelie bin storage units by vacuum pump along pipework to 15 injection moulding machines. It incorporates a colour coded material selection table fabricated by Summit Systems, which uses brightly painted inlet valves to minimise the risk of material mix ups.
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Sartorius d e v i c e s are for the m e d i c a l and pharma sector so that hygiene is a priority. S u m m i t Systems d e s i g n engineer Stuart Winnall said: “We chose an innovative design that put the pump outside the main building in a purpose built, weather proof and sound acoustic unit. This eliminated issues with noise and dust pollution, and freed production space.” The solution provided also offers efficient operation and a lower energy profile.
DIGITAL SPY
DIGITAL NEWS
talking
Resorbable self-locking loop
POINT
cuts down surgery time
R
esorbable Devices has designed a resorbable self-locking loop for surgical ligation during soft tissue surgery
Previous studies have shown that self-locking loops (cable ties) enable an easier and shortened surgery. However, traditional cable ties are made using nylon, a non-resorbable material which may cause chronic tissue reactions. The use of traditional cable ties in surgery is therefore, now strongly discouraged.
Picture credit: Luca Lorenzelli / Shutterstock.com
Resorbable Devices has solved this material problem by manufacturing a patented self-locking implant in a resorbable material. After the device has fulfilled its intended purpose the material will be resorbed by the surrounding tissues. The implant has been tested by a team of independent surgeons in Brazil for removal of ovaries in dogs. According to Resorbable Devices, feasibility and a shortened duration of surgery compared with traditional suture ligation were demonstrated.
DIGITAL SPY
Smooth operator:
Can a polymer really put an end to crows’ feet? In the quest for everyouthful skin, scientists have developed an invisible elastic skin that reduces the appearance of wrinkles
What is it? Using oxygen and silicone, a polysiloxane polymer has been created by a team from Harvard Medical School and the Massachusetts Institute of Technology. This synthetic material is said to mimic skin. It forms a breathable and protective layer that locks in moisture as well as boosting elasticity.
As it’s invisible, it goes undetected on skin, doesn’t cause any irritation and isn’t affected by sweat and rain.
Tweets with character
Dr Tamara Griffiths, British Association of Dermatologists told the BBC the polymer may have a role to play in dealing with under-eye bags.
In a few more than 140 characters MPN elaborates on one of its most popular tweets from the past month Using egg whites, magnesium and
She said: “The results [with the polymer] appear to be comparable to surgery without associated risks. Further research is needed, but this is a novel and very promising approach to a common problem. I will follow its development with interest.”
The tweet:
Egg whites power drug delivery devices of the future #DrugDelivery #medical@DeptofPhysics medicalplasticsnews.com/news/eggwhite…
What the story?
The BBC might be removing and replacing recipes from its website as we speak but at MPN when we hear of another egg-based medtech invention, we like our readers to know about it. Forget your egg white omelette and Nigella’s pavlova, it’s all about drug delivery.
tungsten scientists from Zhejiang University in China and Cambridge University have created a piece of dissolvable circuitry that could help power drug delivery devices.
Yes of course the MPN team was eggcited by this and clearly it was no yoke that the scientists wanted to develop a transient memory resistor (memristor) with dissolvable components by spinning diluted egg white on a silicon wafer turning it into an ultra-thin film. Then they incorporated magnesium and tungsten electrodes. The result? A device whose performance matched that of nondegradable memristors and worked reliably for more than three months. The proof is in the pudding, as they say…
WWW.MEDICALPLASTICSNEWS.COM
Does it have any other uses? It is thought that the skin may eventually be used to deliver drugs as well as provide protection from the sun. Has it been tested? Researchers have carried out a few tests such as recoil test on skin (pinching it to see how quickly it snaps back into place). They say it performed well. They also reported that skin coated with the polymer was smoother and more elastic than normal skin. It also looked less wrinkly and smoother. Where can you get it? Unfortunately the polymer doesn’t have safety approval yet so for those of you looking for a wrinkle-free face, you’ll have to wait a little while longer…
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NEWS ANALYSIS
Labelling compliance – what you need to know
I
n September 2013, the FDA set out its framework for establishing a unique device identification system to identify medical devices through their distribution and use. Kevin Grygiel, Prisym The system, h i c h ID, examines the w is being past years’ labelling phased in several compliance challenges over y e a r s , surrounding UDI m e a n s hat by implementation t2020 most medical devices will need to include a Unique Device Identifier (UDI) in human and machine-readable form. In addition, device labellers must submit mandatory data about each device to the FDA/ National Library of Medicine’s Global Unique Device Identification Database (GUDID), enabling the public and healthcare stakeholders to access and download device information. The FDA’s introduction of the UDI system has a number of goals: • To drive more accurate reporting and analysis of adverse events, ensuring problem devices can be quickly identified and rectified • To reduce medical errors by giving healthcare professionals key information about specific devices • To enhance market analysis with access to real-world data on device usage • To provide a standard identifier to help manufacturers, distributors and healthcare providers to manage product recalls efficiently • To provide a platform for a secure global supply chain that protects against counterfeiting and can respond effectively in a medical emergency
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FDA UDI definition/guidelines A UDI is a unique numeric or alphanumeric code that consists of two parts: • A device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device, and • A production identifier (PI), a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of a device: ■ the lot or batch number within which a device was manufactured; ■ the serial number of a specific device; ■ the expiration date of a specific device; ■ the date a specific device was manufactured; ■ the distinct identification code required by §1271.290(c) for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device. • Each UDI must be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. • The UDI will also be required to be directly marked on a device that is intended for more than one use, and intended to be reprocessed before each use. • Dates on device labels and packages are to be presented in a standard format
that is consistent with international standards and international practice.
The FDA’s definition of a UDI and guidelines on its use are outlined in Figure 1. The complexities of the new system mean that, for many companies, managing the transition to UDI compliance can be a challenging process that touches all parts of the organisation. Critically, the implications for labeling operations are significant and require all medical device manufacturers to examine their current infrastructure and, in many cases, adapt it to enable more holistic label lifecycle management.
First in class The first two phases of UDI implementation are now complete. By September 2014, Class III devices and devices licensed under the Public Health Service Act were required to include a UDI and submit their data to GUDID. The second phase required implantable, lifesupporting and life-sustaining devices to bear a UDI by September 2015. It also mandated that life-supporting and life-sustaining devices intended to be used more than once must include a permanent marking on the devices
themselves. In all cases, once again, UDI-labeled devices were required to submit relevant data to GUDID. So what have we learned from the process so far, and what does this mean for manufacturers facing the 2016 deadline? In the final quarter of 2015, Prisym ID conducted a poll of the industry to find out how the new UDI regulations had impacted medical device organisations. The survey sample included companies directly affected by the first two phases of implementation, as well as early adopters not yet mandated by the FDA’s timetable. 41% of respondents had not yet been required to meet UDI requirements, while interestingly, 8% were unsure whether they had. The overall results provide a good barometer of current feelings regarding UDI across the sector and highlight some key findings that can inform strategies for organisations yet to make the leap. As expected, the majority of respondents whose companies had implemented UDI found the process challenging. 58% described implementation as ‘difficult’
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NEWS PROFILE
with a further 4% regarding it ‘extremely difficult.’ Encouragingly, however, just over a third (34%) reported minimal challenges and 4% described the process as ‘easy’. The challenges were widely anticipated. Almost two thirds of respondents (63%) stated that the impact of UDI implementation on business operations had matched their expectations – though almost a fifth (18%) said it had had a ‘massive impact’.
Labelling at the centre The introduction of UDI capabilities is undoubtedly a cross-functional challenge for all medical device manufacturers. The poll shows that UDI implementation caused reverberations in Manufacturing, Quality, Operations and Distribution. Likewise, UDI projects also tend to involve IT and regulatory teams, meaning that they permeate almost every department and system within an organisation. This naturally dictates a collaborative approach where implementation decisions cannot be made or managed in isolation. However, the poll shows unequivocally that the biggest impact of UDI implementation is typically felt in labelling and packaging. 85% of respondents reported that labelling, packaging & design were affected the most. This is further underlined by data which reveals that companies experienced more issues around their labelling capabilities than any other area. Building and implementing an appropriate labeling system was cited as the single biggest issue, with 23% of respondents encountering difficulties. Alongside this, almost a fifth (19%) found getting a UDI onto the device label their biggest challenge, while 9% reported issues adding a UDI to device packaging. This data shows that, when asked to name their biggest issue around UDI compliance, more than half of all respondents cited issues related to labeling. This is not surprising. Making the move to UDI compliance requires manufacturers to ensure device labels not only include a device identifier (DI), production identifier (PI) and associated barcodes, but also include 13 additional pieces of information. These requirements represent a major shift and necessitate a labeling system that can capture these data sets accurately and efficiently and configure them to the appropriate label design. Ideally, the labelling system would be able to communicate seamlessly with systems that support the submission of data to GUDID. This separate process requires the submission of data covering a total of 62 fields – with data not only coming from the label itself but from various locations right across the organisation 12
Label lifecycle management The impact of UDI regulations on labelling operations is a major reason why Label Lifecycle Management (LLM) is now regarded as a must-have capability for global medical device manufacturers. LLM encompasses the full range of disciplines, processes and controls that go into the preparation, production and audit of every single label. Unlike traditional labelling systems that focus purely on the final output – the label itself – an LLM system focuses on data, supporting the end-to-end management of labelling across its entire lifecycle. It gives companies full visibility of all their data assets as well as editing tools and vision control to help maintain data integrity. Crucially, an LLM system assures robust data validation and reinforces it with transparent audit tools that can supply objective evidence in the event of internal or regulatory inspection. These capabilities are crucial if organisations are to meet the regulatory requirements of UDI. However, Prisym ID’s survey shows that only 40% of companies polled are confident that they are ready for an FDA inspection that includes UDI activities. A third of the sample do not believe they are ready while 27% are unsure. More specifically: • Around 45% of companies sampled believe they are either unable or uncertain as to whether they could provide any correction or removal reports they have submitted since the UDI rule was introduced • Around 36% cannot, or are unsure whether they can provide DIs, the issuing agency and packaging configurations from the GUDID DI record for each premarket submission number • Almost a fifth of companies (19%) cannot provide Medical Device Reports (MDRs) submitted since UDI was introduced, and a further 19% are unsure • More than a quarter (26%) of companies cannot, or are unsure whether they can, provide a sample of devices listed including the device class, product code and premarket submission number Perhaps most significantly of all, only 43% of companies believe that their quality system includes the processes and systems used to maintain the data attributes submitted to GUDID in compliance with 21 CFR part 820 and part 11. Almost a fifth (19%) admit that their quality system falls short of requirements whilst a further 38% are unsure. WWW.MEDICALPLASTICSNEWS.COM
In each of these cases where a medical device organisation believes its operations may fall short at FDA inspection, an LLM system can help mitigate that risk. Fully integrated LLM solutions allow companies to take a more strategic approach to the management of global data. Moreover, they improve quality control with the use of automated validation systems and provide comprehensive audit capabilities to ensure all documentation is recorded, stored and quickly accessible whenever required. Validation is a critical aspect of the labeling process. Companies need to be able to prove that an action has taken place and demonstrate the outcome it yielded. As far as the FDA is concerned, if you cannot prove it, it didn’t happen. This black and white approach to audit is driving the need for companies to ensure they deploy a fully validated system that can close the gaps and limit labeling errors that could lead to product recall.
Assuring readiness It’s therefore no surprise that medical device companies are increasingly looking to improve their labelling systems to ensure operations are UDI compliant. There is a growing trend towards the implementation of ‘vision’ systems that automate label inspection, post-print. This is a smart move for companies aspiring to achieve zero defect labelling; organiations are investing a huge amount of time and money to ensure labels are UDI compliant – so why risk an FDA recall or warning letter by potentially bringing in human error? The most progressive organisations are deploying end-to-end LLM systems that give them a 360° view of all their data via a centralised global platform that interoperates with existing systems right across the enterprise. LLM solutions give manufacturers the reassurance of complete label integrity – a single version of the truth – across the entire label lifecycle. Moreover, they provide a secure, reliable and scalable platform for efficient UDI-compliant labelling. With more than half of all survey respondents citing label-related issues as the biggest challenge in the journey towards UDI implementation, it makes sense for manufacturers of Class II devices to ensure they have the optimal labeling solution in place as they approach September’s FDA deadline. An LLM solution can not only help them meet the regulatory challenges that lie ahead, but it can also help them meet their wider strategic goals of efficiency, productivity and, ultimately, profitability.
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NEWS ANALYSIS
Why is 2016 the year for additive manufacturing in the medical sector?
Heart of the matter: 3D printing of organs and tissues will revolutionise transplants and patient care, says Cyient
BY ANIRUDDHA SRINATH, PRODUCT REALISATION TEAM AT CYIENT
I
n recent years, additive manufacturing has emerged as one of the most in-demand technologies in the world and is changing the lives of millions worldwide. Additive manufacturing is defined as the process of joining materials to make objects from 3D model data, usually layer upon layer. This differs from traditional subtractive manufacturing methodologies, where a design is shaped by removing material from a solid or hollow mass. Its rise is often considered synonymous with industrial manufacturing and to have been boosted by enhancement in digital technologies. Last year in particular, the capabilities of additive manufacturing began to be explored in the medical sector in greater detail than ever before, building on years of development in this area. Indeed, thanks to the renewed time and investment placed in the technology in recent times, it is now the source of some of the most cutting-edge and innovative developments within healthcare.
5.15 4.17
+25% CAGR 3.37 2.72
1.07
2009
1.33
2010
1.72
2011
2.20
2012 2013E 2014E 2015E 2016E
Figure 1: Annual Global Sales of Additive Manufacturing Equipment ($ Billions) (Source: BCG Perspectives)
As shown in Figure 1, the growth of the additive manufacturing industry shows no sign of abating, and the industry is projected to be worth more than $5 billion by the end of the year, having experienced 25% compound growth every year since 2009. But this isn’t solely based on the manufacturing sector – far from it. The medical and dental markets represent a significant portion of this growth, and are estimated to account for 14% of additive manufacturing equipment sales globally. Dentistry has played a significant part in this, as use of the technology has allowed industry professionals to 3D print orthodontic and dental equipment, and consequently increase the number of services they are able to offer.
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Additive manufacturing making its mark in 2015
Last year, medical additive manufacturing was more than a match for its 3D printing counterparts, and witnessed substantial growth in a number of areas. The most notable of these was in mass customisation, such as patient-specific surgical implants; where for the first time, surgeons were able to use additive manufacturing to 3D print implants that were tailored to the individual recipient and fitted them perfectly. This will prove hugely beneficial to patients in the future, as they will receive an implant that responds to their bodily movements perfectly, unlike standardised implants, which can be an awkward fit. In time, this should result in a better clinical outcome for the patient, by removing any scope for potential discomfort, enabling a more expedient surgical procedure, as personalised implants require fewer adjustments during surgery and reducing the overall recovery period. Aside from implants, medical institutions were also able to produce customised orthopaedic devices and pre-surgery preparation aids for surgeons, which will help improve the treatment that patients receive while using healthcare facilities. Commercially, last year also saw some of the main players in additive manufacturing make waves in the medical sector. For instance, one of the two major 3D printing companies for plastics, Stratasys established its own medical solutions group, a move which shows a clear desire to be an integrated solutions provider that can handle all aspects of the 3D printing lifecycle in medicine. Likewise, the year also saw a marked increase in commercial partnerships. Most notably Materialise, a Belgium-based, medical additive manufacturing software company, partnered with multiple organisations, including Arcam, to improve its lead times and reduce product development lifecycle costs through strong software support for all processes.
Healthcare – ripe for additive manufacturing growth
Such are the benefits of additive manufacturing that in recent years significant investment has been allocated to this area. As a result it is now one of the best-funded fields of medical research. To a certain extent, this can be attributed to the influence of the private healthcare sector; where the rapid rate of innovation and consistently high levels of demand that exists within the market have caused companies such as Siemens and Medtronics to significantly increase their R&D budgets in a bid to stay ahead of the other players in the market. This competition should be seen as a positive, as not only do the general public benefit from pioneering new medical treatments but organisations continue to drive each other to explore the realms of what is medically possible.
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NEWS ANALYSIS
Single solution: Additive manufacturing allows for an entire prosthesis to be produced in one go, which can be fitted according to the patient’s dimensions
The medical industry also has a significant cost advantage over other sectors when it comes to innovation in additive manufacturing. Take rail and aerospace for example – both are heavily governed by bureaucracy, regulations, and regional jurisdictions; aircraft design in particular is governed by a range of airworthiness directives. This contrasts with medicine, which on the whole is more willing to push the boundaries in pursuit of improved clinical care. Of course, there are cases where approval is needed for new products - the US Food and Drug Administration requires approval for any surgical implants, for instance – but advances in medical technologies are increasingly pushing the boundaries of what is possible using additive manufacturing techniques. There have even been a few recent cases where emergency permission has been granted for implants such as 3D-printed tracheal splints, which is a new frontier in the treatment of respiratory illnesses. Human and veterinary medicine encompasses a range of treatments and remedies and there are undoubtedly many areas of the discipline in which additive manufacturing can make an impact in the future. Currently however, there are three specific areas that we see are fostering new growth: • Orthopaedic devices: Joints that frequently require replacement or intense management due to overexertion such as the knee, the hip and the spine have been the subject of intensive research when it comes to additive manufacturing. It is hoped that in the future the replacement of joints with customised 3D printed artificial versions (which correspond to recipients’ exact measurements by surgeons) will become commonplace. • Prosthetics: Prosthetic limbs have been in production for some years now but previous examples have taken a long time to produce, given the fact that they are manufactured on a piece-by-piece basis. Additive manufacturing however, allows for an entire prosthesis to be produced in one go, which can easily be fitted according to the patient’s dimensions. • Bio-printing: Bio-printing represents one of the most exciting developments to date when it comes to organ transplants and donations. Additive manufacturing technologies have advanced to the extent that the 3D printing of organs and tissues, which will revolutionise transplants and patient care, is not far away.
What next for additive manufacturing in the healthcare sector?
Surgery remains one of the most complex and highly-skilled disciplines within medicine, and additive manufacturing isn’t going to change that. While robotics has helped to enhance a number of surgical procedures, human expertise will undoubtedly remain integral to complex operations for the foreseeable future. But that’s not to say that additive manufacturing can’t be used to improve surgical practices – far from it. - 3D printing as a surgery assist We envisage that customised implants will be used more and more frequently in surgery, giving them a replacement that fits them perfectly and reduces the likelihood of further surgery being required.
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This could happen through the introduction of 3D printers to hospitals and medical facilities. Giving surgeons 3D printers and training them how to use them would empower them to more closely assess a patient’s requirements and produce a replacement in a relatively short time, which could then be fitted during surgery. This could be life-changing for patients – implants and transplants will be more readily available, in a shorter space of time, and be tailored to the recipient. It will also help to de-skill and reduce the cost of surgery, which when applied to developing economies, could have a significant impact. In countries where access to expert medical care may not be so readily available, providing 3D printers and the associated training to surgeons could give millions of people unprecedented access to life-changing surgery - this is truly exciting. - The increased availability of biocompatible materials To make these implants and transplants feasible however, the influence of biocompatible materials on the additive manufacturing market will need to increase, and fortunately there has already been significant progress in this area in recent years. While the 3D printing of plastics is now well established, plastic implants can’t be placed into the body due to the chemicals used within the material. As such, implants rely on metallic 3D printing, which historically, has been far less advanced than plastics. However, metallic 3D printers are starting to emerge into the market, largely thanks to the growth of major players in Germany and Sweden like EOS, SLM and Arcam. By increasing the depth and breadth of the biocompatible additive manufacturing market, the possibilities for implants will develop significantly. - Patent expiry and the reduced cost of innovation The third and final area of focus for the years ahead will be on patents. As is common practice with manufacturing equipment, 3D printing machinery is governed by patents that stipulate that any such devices are designed in a specific way. A large number of these patents however, are due to expire, which gives manufacturers scope to be more innovative with their machinery and subsequent development of new printing technologies, and further opens up the boundaries of medical innovation in additive manufacturing. This forms part of an increasing trend towards widespread adoption of additive manufacturing techniques across all sectors – not just medicine. As a result of decreasing equipment costs and an increase in the production of plastics in China, the overall cost of additive manufacturing has fallen significantly in recent times, and is consequently helping to foster growth in the sector. These reduced costs are very significant, particularly in medical terms, because they increase the amount of budget that firms can allocate to further innovation. The ability to print in different colours and sizes at the same time, for instance, is just one of the potential innovations that could be realised in the not-too-distant future. While additive manufacturing may still be in its infancy, it has a strong foundation for use in healthcare. What is most exciting is that the true limits of what can be achieved have yet to be explored.
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Q&A
VOCAL
exercise What excites you about this industry?
Q&A
Who are you and what do you do?
We are Dr Thomas Frame and Dr Thomas Harle of Fourth State Medicine (4SM). We have developed a plasma pen, with the help of design consultancy Triteq, that could revolutionise cosmetic and aesthetic surgery. The pen will transform surgical procedures into non-invasive treatments. The company began with a space technology engineer and an applied plasma physicist – both with an entrepreneurial spirit and a thirst to make a difference. Having both come from the space sector, we love beautiful hardware especially when it solves a serious problem, so we created technology that has various applications, from cosmetic surgery to advanced wound care treatment. We believe that by using our knowledge and expertise we were able to come up with something practical that will revolutionise cosmetic and aesthetic surgery. The possibilities for the future of our technology are endless.
How would you sum up your company?
4SM is first and foremost a medical manufacturer but we also have a strong philosophy about how we like to work. We believe innovation comes from freedom and we love encouraging our employees to contribute and share ideas. We try to maintain a culture of openness. This approach enables us to develop a range of exciting, novel technologies.
Name a business achievement you are most proud of.
We have many achievements we are very proud of ranging from our first Franken-prototype that literally coughed its way into life to our first tiny office. If we had to pick one achievement it would have to be getting to a stage where we could bring in our first employees.
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We love solving problems. Engineering to solve a biological problem is an incredible challenge that requires creative thinking. Unlike the space industry which can take five to 10 years for innovation to be realised, Fourth State Medicine can quickly make a difference to people’s lives. This is a constant source of excitement.
Where do you predict industry growth will come from over the next 12 months?
New innovations that offer a combination of treatment, speed, efficacy and ergonomics are where demand will lie. Companies that produce unique, attractive, small, dynamic alternatives to traditional technologies such as lasers are where growth will lie. We also think smaller companies that challenge large industry players are where the best inventions will be established, with start-ups or spin-outs like ourselves leading the market into a new era of technology. This will breed a new range of therapies and treatments that are built on a heavy base of science, clinical data and with the end user always in mind.
Which medical plastic device do you wish you had invented and why?
We are in the fortunate position that we can invent the devices that we think should be invented but a device we would love to have been the inventors of is the disposable plastichandled scalpel. Granted it’s not particularly high-tech until you look at the weight, shape, material and form factors. There is simplicity in its design and power in its use. From cosmetic surgery through to life-saving treatments this device is definitely underrated and often overlooked.
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DIGITAL HEALTH
Dream
a little
Every business wants to know what lies ahead. As smart devices become the norm, Aaron Johnson, Accumold, looks at the future of medical device design and the role that micro moulding has to play The device of tomorrow, today there’s an app for that! The growing convergence between medical device and consumer electronics has not only brought some incredible innovation to the end user it has also brought an interesting kind of pressure to the design and manufacturing world. The general population of the modern world has come to expect that all of their devices, medical or not, be ‘smart’ in some way.
What is micro moulding?
There is also a growing expectation that a devices built for a While micro moulding as a technology special purpose now function in multiple and sometimes in isn’t necessarily new the interest level is at an completely foreign ways. It wasn’t a stretch to accept that a all-time high - and so is the confusion of what it is and how to hearing aid could double as Bluetooth connection between a design for it. Part of the definition includes something related to mobile phone or television, but what if it also took the term ‘micro’ but there is not a standard textbook your temperature, measured your heart-rate or definition. In general, micro moulding can be looked at in counted your steps? It’s already connected to one of three ways: moulded parts that are micro in size, your body so why not? Think of all of the items micro in features or micro in tolerance. While in many worn by individuals that could have multiple cases a part design could include all three aspects any functions. Any one of them could function as a one of these can define true micro moulding. medical device (or quasi-medical device) - many of which already do. So what’s next? One of the key Drawing the line between micro moulding and
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This demand is not only for at-home personal care devices, but for the doctor’s office as well. The “smart” diagnostic device, surgical tool or delivery apparatus is of equal interest among medical professionals. This interest is also compounded by the fact that there is need for these tools to be smaller, less invasive and in many cases disposable. What do these demands and interests do for the already crowded and complex device? How can they even be manufacturable?
technological innovations that enables the design and manufacture of next generation medical devices is micro moulding.
The demands on tomorrow’s medical device is stretching beyond the standard supplychain capabilities in many ways and it has become necessary to enlist new technologies to push the limits of device design. One of the key technological innovations that enables the design and manufacture of next generation medical devices is micro moulding. This technology has allowed devices to shrink in size, become more complex, reduce manufacturing efforts and open design to new possibilities - with it, however, has come a series of common questions as to the best ways to understand and utilise micro moulding to its fullest. Understanding the answers to these important questions will allow for better and quicker device design efforts.
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conventional moulding is not cut and dry. It may be safe to say moulded parts under 1 mm in size are for sure micro, it’s important to note there can be larger parts with features that are well under 1 mm, even approaching 1 µm or less that can also be considered micro moulding. While the overall dimensions of the part are “big” the features demand a skill in mould design and processing beyond most conventional approaches. The same goes for tolerances. Everyday positional or geometric tolerances for micro moulding are around 25 µm and start to push the limits around 2 or 3 µm. Larger moulded parts with tolerance expectations near these numbers can also be considered micro moulding.
There is also some confusion that micro moulding is only defined by the press size being used to mould the parts. The press size does play a critical role in micro moulding but only for the same reasons one would pick a large press for larger parts. The moulding machine must match appropriate efficiencies to the part design so that less material is wasted and the tool can be balanced and controlled very precisely, especially when using expensive implantable materials and/or when the tolerances on the part design are very tight. In theory any sized moulding machine can make micro parts, however there are practical and physical challenges the larger the mismatch between the part size and press size.
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dream One of the best ways to tell if a part design is approaching micro moulding is by the reaction of the supply chain. It will be fairly evident how difficult the part design might be by the number of ‘no-quotes’. Seek out those that consider themselves as experts in micro injection moulding and tooling to gauge efficacy of the project when unsure.
How is micro moulding different from conventional moulding? In the most basic of comparisons there is no difference. Just like with conventional moulding, micro moulding is an injection moulding process with all of the standard requirements that any moulded project would require. For example, just as with the conventional method, any micro mould design will require a way to process and inject material into the mould cavity, the mould will require the ability to open and close, and the moulded part will still need to be ejected in some fashion. These requirements are most often overlooked when someone is new to micro mould design. There is nothing magical about micro moulding that allows the process to skip the conventional requirements. That being said there are some key distinctions that set micro moulding apart from the conventional process. Despite some beliefs, micro moulding is not just large part moulding made smaller. The relationship between the part geometry, the material selection and tool design become more intertwined the smaller and more complex the part design becomes. Understanding how to build a mould for a micro part design so that the material will fill each feature to the desired tolerance, every time, is not as easy as it sounds. The expertise is in knowing how to balance these relationships effectively given the delicate interaction between the geometry, the material and the processing. Moulding tools must be designed and crafted with artistry and skill in order to replicate the finest of features and maintain a robust and repeatable moulding process. Creating features under 1 mm or tuning a mould to achieve a few microns of tolerance necessitates a tool room operation dedicated to the art of micro moulding.
Are there any guidelines I can follow? The most challenging aspect of design for micro moulding is knowing where and when the limits can be pushed. At the extreme end of the capability subtle changes can mean the difference between success and failure. This sensitivity to the design makes it very difficult to draw hard and fast rules. Setting standards that are too tight could possibly hinder creativity in the design and setting them too loose leads to frustration. As a general rule, start with the ideal part design recognizing where the model may be pushing the limits in terms of size and/ or complexity. At the same time don’t forget the general mould
design guidelines concerning gating, mould opening and ejection. In addition, it is often thought that micro moulding produces no flash. This of course is not accurate, albeit the flash is measured in microns, it is still there. Be sure to keep flash requirements on the callout for areas like the parting line, gate vestige or any potential witness marks that may interfere with the functionality of the part. Other considerations are draft specifications, surface finish or critical design feature needs. The best guideline however will be the Design for Manufacturability (DFM) discussion with your micro moulder. The experienced micro moulder often times can lend a hand with knowing what can be accomplished. It may be more important to start this discussion before your design is complete when designing for micro moulding. Don’t let the ideal part design suffer, it may be feasible as designed.
What should I know about material selection? Material selection can be the most difficult part of any micro mould design process, especially when it comes to any regulated medical device or component. The relationship between the material selection and the feature performance is exaggerated at the micro level. For example, one part designed with a highaspect ratio, thin-wall section at 75 µm thickness with material A (LCP) can run a 42:1 aspect ratio, material B (Nylon) runs 14:1 while material C (PEEK) only 3:1 - same geometry, extremely different results. The difficulty is compounded by the fact that there is really nowhere standard to look for materials that will work with any given geometry. The material data sheets are good for basic details but don’t account for the potential at the micro level. On top of that, materials selection was probably based on the inherent material properties and/ or regulation approvals, not its ability to flow in thin-wall sections. Matching the material requirements to the geometric requirements can be very challenging. Often the only solution through this difficult part of the process is the DFM conversation with your trusted micro moulder. Knowing what materials can do, and in what situations, is based on years of experience working with the resins. Knowing where the limits can be pushed is an invaluable part of the micro moulder’s depth of knowledge.
The good news This good news is that micro injection moulding can open up a whole new world of part design. This capability can be translated into new creativity allowing medical device OEMs to bring new and innovative product to the market. Not only will this technology allow for the manufacture of complex micro parts, but manufacturing in plastic in many cases reduces part cost, reduces weight, and allows for functioning products to be made using fewer overall components- a design feature desired by everyone.
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DIGITAL HEALTH
THE PATCH TEST W
earable technology plays a prominent role in today’s healthcare transformation. Wearables are closely intertwined with an evolving healthcare delivery model. With this new model, care is being brought to the patient, wherever he or she is, rather than the patient having to visit a medical facility.
According to Deepak Prakash, Vancive Medical Technologies, wearable medical technology is opening new healthcare frontiers. Skin-worn patches present one path to remotely and accurately capture and monitor vital signs and other health information
At the same time, many medical devices are undergoing an exciting design refresh to enhance the patient experience. They are becoming smaller and more mobile, opening new alternatives to traditional ways providers have interacted with patients, performed tests, collected data and delivered treatments.
Wearables come in many forms. There are smart wristbands, watches, shirts, shoes, shorts, caps, headbands, eyeglasses, belts and necklaces etc. Most contain sensors that gather raw data which is then fed to a database or software application for analysis. This analysis typically triggers a response. For example, it might alert a physician to contact a patient who is experiencing abnormal symptoms or it might send a congratulatory text message when an individual achieves a fitness or diet goal.
This article focuses on skin-worn wearable patches. This type of wearable does not require straps, buckles or bands. Instead, it is secured directly to the skin. Body-worn patches take a variety of formats, ranging from tattoo-like transparent films to coin-sized pods that adhere to various parts of the body.
Medical wearables – a burgeoning opportunity
In a 2014 report, Soreon Research linked the emergence of wearables to the beginning of a “deep transformation of the healthcare sector,” driven by four factors: 1. A shift from disease treatment to prevention, 2. Greater personalisation of medical care vs. a one-sizefits-all approach, 3. Growing importance of medical standards based on “intelligent interpretation of continuously measured physiological data of a large number of individuals,” 4. New players such as software and hardware companies who are changing healthcare industry dynamics. (Source: Soreon Research.
Projections for the future of wearables vary but there is consensus that the category has high-growth potential: • Wearable technology market: $20 billion (£13.8 billion) in 2015 to $70 billion (£48.4 billion) in 2025. Source: IDTechEx. • Wearable medical device market: $41 billion (£28.3 billion) by 2020, 65% CAGR. Source: Soreon Research. • Clinical and non-clinical wearable patch market: $3.3 billion (£2.3 billion) or 12.3 million units, by 2020 up from 67,000 units in 2014. Source: Tractica. Wearable healthcare applications abound. In its study, Soreon Research focused on the following nine segments. It identified the first four listed (and underlined) below as the biggest growth segments: • • • • • • • • •
Diabetes Sleep disorders Obesity Cardiovascular diseases In-hospital monitoring Geriatry/personal emergency response system (PERS) Asthma Alzheimer’s disease Epilepsy
Wearables also are being used to monitor participants and gather data for clinical research trials and academic research studies. In addition, fitness/wellness wearables are being used as clinical tools. This complements a trend toward counting physical activity as a vital sign category. For example, Exercise is Medicine is a global initiative that has started to make steady inroads in advancing the implementation of comprehensive strategies for the inclusion of physical activity in healthcare. As reported in MobiHealthNews, at the 2016 HIMSS Patient Engagement Symposium, Carolinas Healthcare System discussed how it is collecting data from 70 consumer health and fitness devices. The system analyses it along with clinical data and uses the findings as part of its care management programs for chronic heart failure. For example, through this patient-generated data, the healthcare system can see if a patient isn’t getting enough activity or sleep, and its care team can reach out to identify and treat the root cause of the problem.
Is a patch a good fit? For medical device developers who are exploring wearable options, when could a body-worn patch be a good solution? There is no single answer, but here are some important considerations:
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POLYMERS VELOX EXPERTISE
WE UNDERSTAND MEDICAL • Raw materials supplier • Small quantities just in time • Technical advice at design stage • Change management • Regulatory support • Customised polymer solutions
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DIGITAL HEALTH Wearable patches can monitor physical activity – healthcare professionals are putting more emphasis on measuring physical activity as part of chronic disease management Image courtesy of Vancive Medical Technologies
Comfort and compliance: Patient comfort, both physically and psychologically, is one of the most essential variables in designing a wearable medical device. When a patient is comfortable with a wearable solution, he or she is much more likely to use it as prescribed. Skin-worn patches usually can be worn under clothing, making them an extremely discreet wearable option and preserving the patient’s privacy. No one has to know the individual is undergoing a medical treatment or being monitored by healthcare professionals. Likewise, because many patches are designed to be worn around-the-clock for several days to a week, they require little to no attention from patients. They can go about their daily activities without having to remember to recharge a battery or take their wearable device on and off to do the dishes or shower. The patient can all but forget about the device. All of these factors can be important for healthcare applications that require uninterrupted monitoring for multiple days. Data quantity and quality: The type and amount of data to be gathered play major roles in determining the wearable form factor. With advances in sensor miniaturisation and battery solutions, a lot can be packed into a patch. As with any wearable solution, there may need to be trade-offs in the number of data points collected, the use period and processing power. Generally speaking, the greater the intimacy between the wearable device and the signal it is collecting, the stronger the data accuracy. Because patches provide such direct contact with the skin, they can detect very subtle changes in the patient’s physiologic condition. For example, a patch worn on the chest can sense heart signals with high accuracy. For this reason, patches can be a compelling solution for cardiovascular monitoring and disease management. For some physiological monitoring, such as that involving cardiac and muscle signals, a patch form factor may give the most viable signal from skin contact. There are other reasons to consider skin-worn wearables. Do you need to deliver a therapy through the skin? Can you utilise signals related to perspiration? Do you want to sense changes in the blood just below the skin’s surface? For example, research continues toward a non-invasive way to measure a diabetic patient’s glucose levels through the skin without having to draw blood. Someday, there could be a wearable patch that not only detects blood glucose but administers insulin as needed.
Wearable patch material selection Wearable patch material selection has to be a high priority because no matter what is inside the patch, if it does not adhere properly or comfortably, the healthcare application is unlikely to be successful. Not all adhesives are created equally. Here are some key characteristics to seek in next-generation adhesive formulations for wearable patches. Skin-friendly qualities: The patch material will need to be gentle and conformable to the body’s contours. The latest generations of adhesive medical materials are very thin and breathable. They also feature just the right release chemistry, so that the patch adheres reliably yet also releases from the patient’s skin with minimal discomfort when it’s time to take off the wearable device. Extended wear: Leading materials’ suppliers can deliver different types of adhesive systems depending on how long the patch must be worn. They can address a variety of use cases, such as whether the patient will be showering or exercising repeatedly during the monitoring period. The adhesive formulation also can take into account variables such as whether the patch will be exposed to soiling or other stressors. Extended wear requires efficient moisture management. Modern medical-grade adhesive materials offer a carefully controlled moisture-vapour transmission rate. This ensures the right balance of adhesion and absorbency.
Partnerships are important In wearables device development, there is a need to forge alliances with partners with expertise in diverse areas. This is especially important in wearable patch development. Rarely does a single company have enough talent and specialisation in-house to master all of the core competencies. Wearable patch technology can benefit from knowledge in many areas (see Table 1).
Table 1 Wearable Patch Development: Diverse Expertise Counts
Clinical healthcare and physiology
Advanced materials science
Skin science
Adhesive chemistries
Material performance characteristics and production technologies
Contract manufacturing, such as slitting, finishing, converting and packaging
Consumer electronics (mobile devices)
Sensors and processors
Battery science
Data analytics and algorithms
Cloud computing
Wireless technology
Medical device regulatory requirements
Pharmacology (for drug delivery)
Clinical trial protocols
Software development and EMR
Social media/app development
In its report, “The Wearable Health Revolution: How Smart Wearables Disrupt the Healthcare Sector,” Soreon Research stated: “New technologies are being developed by innovative medtech companies, pharma, mobile phone manufacturers, software companies, start-ups and research organisations around the world.” Who will be among the next wearable innovators? Is a patch the answer? With the right partners, device developers can see how their solutions could be integrated into a skin-worn patch and from there, work toward turning vision into reality. Sources: Dolan, B. (2016, March 1). Carolinas HealthCare monitors Fitbit data to intervene with CHF patients. Retrieved from MobiHealthNews: http://mobihealthnews.com/content/carolinas-healthcare-monitorsfitbit-data-intervene-chf-patients Exercise is Medicine. (n.d.). Retrieved from http://exerciseismedicine. org/ IDTechEx. (February 2015). Wearable Technology 2015-2025: Technologies, Markets, Forecasts. Retrieved from http://www. idtechex.com/research/reports/wearable-technology-2015-2025technologies-markets-forecasts-000427.asp?viewopt=showall Soreon Research. (2014). The Wearable Health Revolution: How Smart Wearables Disrupt the Healthcare Sector. Zurich: Soreon Research. Retrieved from http://www.soreonresearch.com/ wearable-healthcare-report-2014/ Tractica. (2015, May 18). Connected Wearable Patch Shipments Will Reach 12.3 Million Units Annually by 2020. Retrieved from https:// www.tractica.com/newsroom/press-releases/connected-wearablepatch-shipments-will-reach-12-3-million-units-annually-by-2020/
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INJECTION MOULDING
L
Liquid assets
iquid silicone rubber (LSR) injection moulding is an industrial process that has been around for years. Its use has significantly expanded recently, especially in the areas of medical devices and wearable technology, as well as automotive, infant care, and household goods. LSR cures faster and offers properties not obtainable with traditional rubber materials, especially heat resistance, extreme low-temperature flexibility, chemical resistance, As liquid silicone biological inertness, and an intrinsic capacity for rubber grows in reducing friction. The material’s expanded use popularity with has resulted in the development of new LSR process equipment, especially technology that medical devices and optimises LSR injection moulding machines to wearables, Peter provide the greatest value and ease of use. An Linder, Graco says example is the development of new closedthat successful loop control systems, including those found in the Graco Fluid manufacturing Automation F4 series.
depends on getting the best from LSR basics injection moulding equipment The basic
raw material for silicone rubber is sand, or silicon dioxide. The material is processed into pure silicon metal. It is then reacted with methyl chloride, after which a range of processing steps is used to create a variety of silicon types, including liquid. LSR is a two-component reactive chemical with a thick, almost paste-like consistency, which has been compared to peanut butter. The two components are usually shipped in separate containers. Some medical-grade silicones are shipped in small disposable plastic cartridges. The two components are mixed in a 1:1 ratio to produce a reaction. Accelerated by heat, the two liquids change to a solid rubber. LSR injection moulding is an inherently clean production process because the component chemicals are sealed within a closed system. No ambient air contacts the parts until they are removed from the mould, eliminating issues with dust and moisture. This also improves part quality, because contaminants can diminish the cured rubber’s physical properties.
Benefitting from LSR LSR material technology is changing rapidly. Use of LSR is growing in both traditional rubber applications and those where traditional rubber materials had not previously been used. Key examples include medical devices, wearables, automotive, industrial and even such home goods as bakeware and kitchen tools. Medical devices – LSR’s inert qualities make the material ideal for many medical device types. LSR cures completely and quickly. This is especially critical when medical devices are placed in a patient’s body, because it means the device will not leach chemicals and cause potential adverse reactions. By contrast, latex, a material long used in the medical industry, does not fully cure during production, and can lead to adverse patient reactions. Due to the material’s chemical makeup, it does not degrade until heated to very high temperatures – way higher than most other polymers could tolerate. This means it can handle sterilisation processes, contributing to its effectiveness for medical and baby care uses. A final (and critical) advantage is the ability to use LSRs to manufacture drug-eluding devices (DEDs). For example, hormones used in the NuvaRing contraceptive product are injected as an additive in the LSR dosing process. LSR DEDs can also be placed in pacemaker heart catheter leads, enabling the leads to introduce anti-inflammatory medication directly into heart tissue for improved results. Wearable technology – Wearable fitness trackers such as FitBit and Jawbone are largely responsible for the expansion of the flexible wearables category. With its ability to handle both high and low temperatures, ultraviolet (UV), and ozone without degrading, LSR is a better fit than traditional materials for wearable technology used under constant sun exposure. Unlike other rubber, products manufactured with LSR are unlikely to cause adverse skin reactions when worn by users, even for extended periods of time.
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LSR material technology is changing rapidly. Use of LSR is growing in both traditional rubber applications and those where traditional rubber materials had not previously been used.
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Optimising the LSR production process To achieve LSR’s myriad benefits for such a variety of applications, LSR injection moulding machines must be optimised to provide the greatest value and ease of use. While LSR equipment is similar in many ways to the plastics industry, many plastic toolmakers try to manufacture LSR tools in the same manner as a plastic tool, which can lead to manufacturing failures. It is essential to use toolmakers with a specific track record making LSR tooling. Also critical is working with an injection moulding machine company that can assist with processing challenges, since successful LSR manufacturing requires that all components work properly together. The most common pain points in LSR manufacturing are managing waste and controlling colour changes and additives. Excess material is wasted because it is difficult to reclaim it due to such issues as air bubbles, loss of certification, and a lack of lot tracking. Colour changes can pose production down time, because extensive cleaning processes between colours can take as long as four to six hours. In addition, control of colour or additives is also a concern, especially controlling functional additives in the medical device industry. Both waste and increased additive control can be addressed through new closed-loop control system technology being developed. For example, the Graco Fluid Automation F4 series systems use a dosing valve and a high-resolution flow meter to provide a closed-loop control for third and fourth stream additives, such as colour and medications. The system monitors and adjusts to ensure the additive is being dispensed in the appropriate amount. If there is an out of tolerance condition, the system stops production to prevent manufacturing bad parts. In addition, controlling the flow of the two primary material components in a closed-loop system allows the machine to react to changes in the material viscosity and the presence of air bubbles. Operators can vary the ratio to ensure the correct amount of material is used. The closed loop control of the two-component LSR’s dispense ratio is achieved by monitoring the material flow using highresolution, helical gear-style flow meters. The helical gear uses multiple gear teeth to measure the flow in very small increments. Information from these flow meters is fed back to the controller, which operates the valve to alter the flow of material to the flow meter, forming the closed loop.
The increased number of measurements provides more assurance that the machine is running on-ratio to prevent manufacturing of bad parts. Closed loop control therefore significantly reduces waste and rework caused by off-ratio dispensing. The new system offers a simple calibration routine that can be performed by the end user as necessary for a particular process. This can have a significant impact on product quality. The sample is collected and weighed, and the resulting data is entered into the advanced display module to calculate the current actual dispense ratio and calibrate the control system. A variety of other controls help to monitor processes, which is important to reliably manage the LSR system for its entire lifetime. An example is the GCA (Graco Control Architecture), which provides longer life cycles than standard PLC products, and has a much faster response time than other control architecture types. Overall, the new technology helps manufacturers reduce waste, ensure proper additive introduction, and control the operation of LSR dispense systems, leading to hassle-free production.
LSR at the leading edge The LSR industry is in a state of rapid expansion, and continues to offer new and improved materials to replace older technologies with longer-lasting, more effective solutions. Improvements to LSR physical properties for individual applications means LSR will likely continue replacing traditional rubber materials in existing industries – and probably move into others. With the advanced LSR dispense and production technology currently on the market, the manufacturing of LSR products can be managed to minimise issues and take full advantage of this material’s wide-ranging potential.
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24/03/2016 09:33
DIAGNOSTIC DEVICES Microfluidics make great use of polymers for smarter diagnostics
At the front line
when choosing a high performance polymer…
T
A smartphone readout from the PAD system reveals the pathogens responsible for an infection and factors such as antibiotic resistance.
he face of diagnostics has changed massively in recent times. For one thing, the diagnostic process now has a face. The last two decades have seen less reliance on behind-the-scenes lab testing and a rapidly increasing availability of tools that allow for point-of-care Polymer diagnostics. Early detection prevention are now, innovation is and in many fields of study, far bringing clever more important than finding cures and treatments.
and futuristic new diagnostic tools to the fight against some of our biggest global healthcare challenges. MPN’s David Gray writes
CREDIT: Chen-Han Huang, PhD, and Ki Soo Park, PhD, Center for System Biology, Massachusetts General Hospital
innovation from those who know that the priority is not identifying how the outbreak could’ve been prevented, but instead ask a more practical question: how do we contain and kill it? Swiss university École Polytechnique Fédérale de Lausanne (EPFL) has developed a device which needs no bulky equipment, making it ideal for use in remote regions of the world. Using polymer microfluidics, the team, headed by scientist Sebastian Maerkl, came up with a portable device that can run on battery power – thus enhancing its portability. The platform can quantify up to 16 different molecules in less than 0.005 millilitres of blood.
So the requirement for more innovation in the field is on the up. Increasingly, photographs of overcrowded hospital waiting rooms are becoming grist to the mill of the doom-mongering tabloid press machine. The solution here is not straightforward, and it involves gradually re-modelling the way that healthcare is delivered – so logic dictates that better, faster diagnostics must have a part to play at the front line.
Antibiotic apocalypse Take for example one of the biggest crises to the healthcare sector today: healthcareassociated infections. Antibiotic resistance has been described as the ‘apocalypse’ for modern healthcare, and threatens to hurl us back to the dark ages. But most commentators have been optimistic that with the right strategy, we can still get on top of the problem. That means early detection and prevention. The problem is that sending samples for analysis to try and detect dangerous pathogens can take days – not to mention highly trained resources and specialised equipment. That’s why a team of Massachusetts General Hospital investigators has developed a plastic device with the potential of shortening the time required to rapidly diagnose pathogens responsible for healthcareassociated infections from a couple of days to a matter of hours.
It uses both analogue and digital detection mechanisms. Using the two together means that a drop of blood can be analysed rapidly – this is crucial for making quick decisions on isolation and quarantining.
The system, dubbed ‘PAD’ (polarisation anisotropy diagnostics), allows for accurate genetic testing in a simple device. Bacterial ribonucleic acid (RNA) is extracted from a sample in a small, disposable plastic cartridge. Following polymerase chain reaction amplification of the RNA, the material is loaded into a two centimetre plastic cube containing optical components that detect target RNAs based on the response to a light signal of sequence-specific detection probes. These optical cubes are placed on an electronic base station that transmits data to a smartphone or computer where the results can be displayed.
Initial testing was carried out successfully on a test sample with anti-Ebola antibodies. The device was able to show the presence of the virus in both symptomatic and asymptomatic patients. This was just one of many diagnostic tools developed in rapid response to the Ebola outbreak.
Diagnostics for global challenges Antibiotic resistance is now a real threat to societies the world over. And the fact is, no new antibiotics have been developed in the last 25 years. While work is being done in the field, experts are turning to other stakeholders for solutions.
Developing world
Similarly, Ebola is not the first, nor will it be the last major outbreak of a killer virus to strike a remote part of the world.
Disease epidemics, when they start, unfortunately kick off a futile chain of finger pointing and blame assigning. There are always guilty parties who should’ve been more prepared. But at the same time, they ignite a flurry of
Diagnostic devices represent one of our best chances of tackling global healthcare challenges. Early detection and prevention is crucial to easing the burden on our health systems, and those overseas.
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POLYMER INNOVATION
Insider knowledge
D
espite their ubiquitous nature in everyday products, negative press coverage of plastics is a regular feature of this decade. Eight million tons of plastic a year now end up irresponsibly in our oceans. The whole of the UK – and many other countries – now associates plastic bags with a small tax to discourage their use. There are negative connotations to In July the University of the term ‘plastic’, and more Nottingham will be at the so the adjective ‘plasticky’, which immediately associates Royal Society’s Summer a product with being cheap, Science Exhibition, London, lightweight and prone to break at putting on Plastics Inside Us, the most inconvenient moment.
looking at the ways in which polymers and biopolymers can be used in medical contexts. Davide De Focatiis, Department of Mechanical, Materials and Manufacturing Engineering offers a sneak preview into what the exhibition holds as well as an insight into the medical plastics work being carried out by the university
I offer counter-arguments to The real deal: The cup of an artificial shoulder is made all of these. The presence of from ultra high molecular weight polyethylene (UHMWPE) plastic in our oceans is the direct consequence of our The same acrylic that is used to inability to properly manage make aquariums or fracture-resistant recycling and re-use, rather greenhouse panes is also regularly used than a flaw with the material itself. The humble plastic The same in the manufacture of intraocular lenses. Most people of a certain age will need bag is a wonder of modern polyethylene cataract surgery to replace clouded engineering, manufactured plastic that is so crystalline lenses and it is a clear plastic at tremendous speeds frowned upon that comes to the rescue in what is now and very low cost, and enabling us to conveniently in plastic bags is a routine operation. Acrylic is even more carry thousands of times the gold standard transparent than glass and far less brittle as well as being biocompatible its own weight. This is the for the bearing and well tolerated by the body as well equivalent by weight of an entire aeroplane’s worth of surface of the cups as helping many people to see well into of hip implants. their twilight years. luggage carried in a single suitcase! The term ‘plastic’ originates from the Greek word ‘plastikos’ and rather While the public knows silicone as the than being pejorative, refers to the manufacturing ease with which the material can be shaped into the sealant that prevents water from running down the side complex parts that make up the cases of our television of the bathtub, this same material is used for a range of medical tubing that take the place of our own body’s sets, computers and kitchen appliances. ageing internal pipework. Not only does it have fantastic flexibility, it is also biologically inert and can tolerate the Improving lives with plastics majority of the bodily fluids it might encounter without adverse effects. And there are other examples – too many Of course plastics are regularly used in a medical context, to list here –each as essential and life-saving as the next. helping to improve the quality of life and save the lives every day. Some plastics have suitable properties for medical implants. The same polyethylene plastic that is so Biopolymers frowned upon in plastic bags is the gold standard for the bearing surface of the cups of hip implants. Many such Many of the reasons why plastics work well in a medical implants survive 30 years or more because of the material’s context are connected to the similarities between the exceptionally low rate of wear and the challenging materials that make up our bodies and those that make manufacturing process that has led to a small number of up plastics. Plastics have mechanical properties that are failures is much better understood today than ever before. more similar to those of biological tissues than to those of metals or ceramics.
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Many polymeric implant components are injection-moulded in the same way as commodity plastics, only in smaller quantitiest Acid test: Bone fracture fixation screws injection-moulded from polylactic acid Photo courtesy of Tesco Associates
Joint forces: The bearing surface of an artificial knee joint
Biology makes use of polymers as building blocks in a variety of contexts, and peptides, lipids and sugars, as well as the nucleic acids are all types of polymers. Plants make extensive use of cellulose - itself a polymer – which is a major constituent of cotton and wood. Polymers that are produced by living organisms – biopolymers – are renewable and an appealing prospect for future plastics. In most cases bioplastics are biodegradable and well tolerated by the body. By using polymers with the ability to degrade, it is possible to design temporary implants that fulfil a function over a defined period of time, but that are eventually absorbed by the body. At the University of Nottingham we are working towards the development of new biopolymerbased nanomaterials for applications such as fracture fixation plates and screws. These are intended to replace the metallic plates and screws used to assist the healing of broken bones, and have a number of potential benefits. Firstly, they do away with the need for a second operation typically required to remove metallic implants after bones have healed. But more importantly, they can lead to better healing by gradually transferring more and more loads to healing bones, helping them to regenerate in the presence of some of the forces they will eventually have to withstand unsupported.
Latest research on medical plastics One of the big research challenges with medical plastics is to try to match the properties of the implants to those of the bones they support and in the Faculty of Engineering we are attempting to do this by incorporating nanoparticles made up of hydroxyapatite, a natural bone building-block, into the polymer itself. Other research areas on medical polymers at the University of Nottingham include the use of degradable polymers for controlled and targeted drug delivery and the use of polymer coatings as antibacterial surfaces to prevent the growth of bacteria on medical devices and implants.
Selection box: A selection of plastic and metal medical devices including an artificial knee and various types of medical tubing
Examples from this and other medical plastic research will be on public display this coming July as part of the ‘Plastics Inside Us’ exhibit at the Royal Society’s Summer Science Exhibition in London. If you want to find out more about the positive aspects of plastics and why we should be thankful for their existence and welcome it in improving our health and ageing rather than berating its use, come and see our display at the exhibition.
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POLYMER INNOVATION Better placed: Siliconebased PSAs offer advantages over acrylic adhesives which can cause skin irritation in some patients
W
Stick with it
ith the growth of wireless monitoring and the move to outpatient and home-based care, more patients are wearing medical devices attached to their skin. In addition to traditional prosthetics, heart monitors and ostomy devices, wearable devices include new designs that enable advanced functionality, such as monitoring skin exposure to ultraviolet (UV) rays or relaying information about body movements Christine Weber to guide proper back exercises. The diversity and Audrey of skin-adhered devices and their growing use outside the acute care setting require new Wipret, Dow pressure-sensitive adhesives (PSAs) that can Corning outline deliver flexibility and breathability without skin – all factors that promote patient how silicone sensitisation compliance.
pressure sensitive adhesives are helping to meet the challenges of medical device adherence
New silicone-based PSAs offer important advantages over acrylic adhesives. Not only can acrylic adhesives cause skin irritation in some patients, but they also tend to increase in peel adhesion over time, making removal of the device uncomfortable. Besides solving these problems, silicone-based PSAs can handle heavier loads than silicone soft skin adhesives, up to several grams, over extended periods. This advanced technology will be an important enabler of nextgeneration wearable device designs.
New wearables call for improved PSAs The global market for wearable medical devices is forecast to grow to $7.8 billion (£5.4 billion) by 2021. This boom is being driven by several trends: • Advances in wireless technology such as Bluetooth Low Energy (BLE), which supports long-term usage and increased connectivity • Consumers’ fascination with self-monitoring fitness bands and smart watches, which carries over into the clinical arena • A rise in chronic conditions, from diabetes to heart disease to COPD, whose management depends on ongoing monitoring; and • Efforts to cut healthcare costs by shifting care to outpatient settings, including the home, while maintaining clinical oversight of the patient These trends are driving the development of new wearable devices that adhere to the patient’s skin and provide a range of functions: • Monitoring of vital signs, sleep quality and exposure to environmental hazards such as UV light • Administering drugs such as insulin through convenient and discreet patch pump devices • Tracking of body posture to prevent or detect falls • Tracking of patient movement to monitor compliance and avoid bedsores • Concussion monitoring • Remote monitoring of patients with cardiac arrhythmias PSAs for new wearable devices need to provide stable, longterm adhesion performance; flexibility and breathability for enhanced patient comfort; practicality for home use, such as 32
water repellency to allow showering and sports activities; and avoidance or minimisation of skin sensitisation. A range of adhesion levels, from light to very high, are needed to support novel designs and different device weights and functions. Silicone PSAs are ideally suited for the increased requirements of new wearable medical devices. Silicone technology checks all these important boxes: • Biocompatibility: Silicones are biocompatible, based on their long history of use in medical devices, including long-term implants. They are non-cytotoxic, non-irritating and non-sensitising to the skin. • Spreadability: Silicones spread easily to form films over skin and other substrates • Permeability: Silicones allow the diffusion of oxygen, carbon dioxide and water vapor to improve comfort.
Innovative Silicone PSAs The Dow Corning MG-2XXX series of PSAs comprises four products that offer device designers and manufacturers a broader choice of properties. They are available in a range of tack and peel adhesion values, solvent types and solid contents to meet specific application needs and processing parameters. Specifically, MG-2402 and MG-2502 silicone PSAs can be processed using conventional roll coating equipment for solvent-based systems. MG-2410 silicone PSA can be applied using conventional hot melt coating equipment and the MG-2401 silicone PSA is designed to be used in applications where the liquid adhesive is brushed or sprayed onto the device.
Material gains: Successful in the healthcare sector for many years, silicones are finding new applications in the wearable device market says Dow Corning
They also deliver performance advantages over traditional adhesives. The four PSA product offerings provide strong, consistent adhesion of medical devices to the skin over extended wear periods, withstanding shear force of up to 21kg. They also offer excellent permeability to gas and water vapour, making them well suited for medical applications in which increased aeration is required. All four grades have successfully passed biocompatibility testing for cytotoxicity, skin irritation and skin sensitisation according to US Food and Drug Administration (FDA) regulations for non-clinical lab studies (21CFR58).
Superior comfort encourages compliance Silicones have proven their success in the healthcare sector for many years, and are finding new applications in the growing wearable device market. Silicone-based PSAs surpass traditional acrylic-based adhesives by avoiding skin irritation and maintaining a stable level of adhesion, as well as providing many other desirable properties. By optimising comfort, these products can make an important contribution to compliant use of skin-adhered medical devices.
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POLYMER INNOVATION
F
Read all about it
antastic plastic indeed. Sitting down to write an article on polymer innovation is no easy thing. Where to start? Narrowing it down to the medical sector does of course Medical plastics help but looking continues to offer back at some up an outstanding of the recent array of innovation. materials news in the sector, it’s Lu Rahman looks still a mammoth at some the recent task choosing breakthroughs for the those that have healthcare market made the biggest impression.
The significance of polymers in the medical sector is huge. Recently Northwestern University announced the development of a new hybrid polymer that, thanks to removable supramolecular compartments that contract and expand, it has the potential work like a muscle.
I’m sure I’m not alone in being excited by the news that scientists at the Massachusetts Institute of Technology (MIT) and Harvard Medical School have developed an elastic film, a polysiloxane polymer, that can be applied to the skin to disguise wrinkles and bags under the eyes. Given that the global cosmetic surgery market is currently worth over $20 billion, according to Global Cosmetic Surgery & Services Market Analysis 2015-2019, the future for a product that could potentially nonsurgically deal with our never-ending quest for a youthful appearance, looks incredibly rosy indeed.
Potential applications of this polymer are varied. As well as artificial muscles, it is being claimed the material could also be used for drug delivery.
It also seems that this polymer isn’t just a pretty face – researchers say it also has potential as a drug delivery mechanism as well as sun protection. Daniel Anderson, an associate professor in MIT’s department of chemical engineering described the material: “It’s an invisible layer that can provide a barrier, provide cosmetic improvement, and potentially deliver a drug locally to the area that’s being treated. Those three things together could really make it ideal for use in humans.” Sounds perfect. Given society’s current obsession with selfies and the growing importance of body image, this polymer could prove a huge hit once it achieves approval. Add to this its possible pharmaceutical applications and who knows how popular the uptake of this polymer may be.
The hybrid polymer is made of two types of polymer – those formed with strong covalent bonds and those formed with weak non-covalent bonds (supramolecular polymers). This gives the hybrid polymer both rigid and soft nano-sized compartments.
Andy Lovinger, a materials science program director at the National Science Foundation, which funded the polymer’s research, said: “This is a remarkable achievement in making polymers in a totally new way – simultaneously controlling both their chemistry and how their molecules come together. “We’re just at the very start of this process, but further down the road it could potentially lead to materials with unique properties – such as disassembling and reassembling themselves – which could have a broad range of applications.” While these examples highlight extreme innovation in medical polymers, many companies in the medical plastics field continue to develop materials that improve the use and manufacture of those medical devices that are used on a daily basis. Increasing numbers of the population rely upon implants, orthopaedic devices and wearable tech, so the functionality of the plastic used, its ability to both endure and perform, is paramount. Cedric Perben, EMEA medical application development, Eastman Chemical Company recently outlined key considerations when choosing a high performance polymer. While
an innovative material that disguises wrinkles clearly has a massive future, Perben underlined the need for materials to be able to withstand harsh drugs, disinfectants, sterilisation, as well as allow substances inside devices to be seen. Materials such as Eastman’s Tritan have been developed to be used successfully in such applications. According to Perben, “The material is resistant to a large spectrum of fluids used in hospitals, including aggressive cleaning disinfectants, powerful drugs including those used in oncology, drug carrier solvents and lipids. This resistance helps decrease the risk of the device cracking and discolouring, therefore increasing patient safety”. Recently MPN reported that the medical polymers market is set to grow to £2 billion by 2021, according to a report by N-Tech Research. It highlighted how implants currently consume about half the medical polymers produced and are expected to account for around £1.19bn in polymer sales by 2021; that medical polymer revenues are spread over a large range of polymers with PMMA as the biggest contributor, generating £530m ($745m) in 2021 and that the last ten years have also seen the rise of biodegradable polymers – according to N-Tech it is likely that entire prostheses soon will be developed from these materials. Longer lives and increased research into illness leading to medical breakthroughs mean that the market for medical polymers is strong. We continue to learn of the demise of metal – add to this the growing development of wearable devices to treat conditions such as diabetes and it’s clear that device manufacture is not only secure but has strong potential. As a growing number of businesses and universities push back the boundaries of research into design and material science, and innovation comes to the fore outlines the crucial role that polymers have and continue to play in the health and well being of us all.
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PLASTICISERS
Choice words W
hile phthalate esters such as DEHP are the DOTP is classified as a non-orthomost widely used plasticisers for flexible phthalate, different from DEHP in PVC medical compounds and have been for terms of animal toxicology and 50 years, issues concerning their possible effects on metabolisation. human health have caused some device manufacturers to The high molecular weight of TOTM consider compounds containing is an advantage over DOTP having plasticisers. to do with the Peter Galland, Teknor alternative Sometimes the pressure phenomenon of Apex Company to do so is considerable. stress cracking As a result, it is possible in connectors examines how many to make a decision based or other rigid factors determine on one factor in favour components that interface the best alternative of a particular alternative What’s the alternative: plasticiser rather than on with flexible PVC According to Peter Galland, While Teknor to DEHP for PVC a comparative study that components Teknor Apex Company Apex is best such as tubing. outlines how to determine medical devices takes all of the important considerations into stress known as a T h e the best alternative to DEHP account. is for PVC medical devices manufacturer of c r a c k i n g caused by the medical-grade m i g r a t i o n o f There are a number of alternative plasticisers on PVC compounds, plasticiser to the market. While Teknor Apex is best known as a we also produce the interface manufacturer of medical-grade PVC compounds, some of these with the rigid we also produce some of these plasticisers. Two alternatives that have received considerable attention plasticisers. component, and it is most pronounced in the case of amorphous rigid materials in the medical device industry are TOTM, a trimellitate like polycarbonate. The stress cracking ester which Teknor Apex manufactures and sells or crazing that weakens the rigid primarily in the wire and cable industry because of component takes place more slowly its low volatility, and DOTP, a terephthalate which with TOTM than with DOTP. we do not produce. Teknor Apex can and does use both plasticiser types in producing medical-grade flexible PVC compounds. To support customers in weighing the It is important to put this advantage of TOTM in pros and cons of available alternative plasticisers we perspective. DOTP may cause more crazing than TOTM have determined that DOTP provides a better balance but resists crazing better than other alternative plasticisers of properties than TOTM for many medical device and even better than DEHP. TOTM is also outperformed in this regard by polymeric plasticisers. Over the years, applications. moreover, device manufacturers have avoided serious TOTM is a monomeric plasticiser whose high molecular crazing issues with DEHP through appropriate design and weight makes it less mobile than other alternative other measures. In addition, it is now possible to minimise plasticisers and for that matter, than DEHP as well. In the issue of stress cracking by using specially formulated, spite of its chemical designation as a terephthalate, stress crack resistant rigid PVC compounds in place of polycarbonate for connectors.
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PLASTICISERS
The crazing phenomenon is only one of the factors that must be taken into consideration when deciding between TOTM and DOTP, or indeed between any plasticisers. Key factors include: Cost. DOTP-plasticised PVC compound of 75 Shore A durometer currently cost less than one plasticised with TOTM. This is because TOTM is far more expensive. In addition, TOTM is a much less efficient plasticiser than DOTP, meaning you have to use more TOTM to achieve the same durometer—and plasticiser today is more expensive than PVC resin. Purity. If processed in truly dedicated equipment, DOTP can be produced nearly free of DEHP contamination. DOTP plasticiser producers specify a DEHP content of less than 50 parts per million, but almost all shipments contain significantly less than that. In contrast, TOTM can contain as much as 2,000 ppm of DEHP and is never free of it. This is because the process for making trimellitic anhydride simultaneously produces some phthalic anhydride which, when esterified with the di-2ethylhexyl alcohol used to make TOTM, is completely converted to inseparable DEHP. Toxicology. All of the toxicology data available for PVC plasticisers is based on rodent toxicology. In a comprehensive European1 study, DEHP is reported to have a NOAEL (no observable adverse effect level) of 4.8 milligrams per kilogram of body weight, while TOTM has a NOAEL of 100 milligrams (see table). By comparison, DOTP is listed at 500700 milligrams, making it 100 to 140 times safer than DEHP for rodents and 5 to 7 times safer than TOTM. The same study listed NOAELs for ATBC (acetyl tributyl citrate), DINCH (di-isononyl cyclohexanoate), and DOA (di-octyl adipate) plasticisers at 100, 107, and 200, respectively. TOTM was also cited to be reproductively toxic for the rodents tested, whereas DOTP, ATBC, and DINCH had no reproductive effects.
Performance. Because of its higher molecular weight, TOTM is absorbed into the porous PVC resin particles during compounding much more slowly than is DOTP or any of the other monomeric plasticisers. A result of poor or slow absorption is un-plasticised or insufficiently plasticised PVC resin particles, which ultimately are manifested in clear flexible tubing or film as gels. REACH status. Four years ago, TOTM was placed on a list for future consideration as one of the SVHCs (substances of very high concern) under the European REACH legislation.2 Although it is unlikely that anything will come of that listing, the mere fact that it was considered reflects on how similarly some analysts think the toxicology of TOTM mimics that of DEHP, with its only saving grace being its lower solubility and mobility due to its higher molecular weight. In all respects, except for the issue of crazing, DOTP appears to be the preferable candidate for replacing DEHP. In fact, although DOTP is a relative newcomer to the global marketplace, it already outsells TOTM by a ratio of 12 to 2. Of all of the plasticisers that have emerged as alternatives to DEHP, DOTP has the largest market share.3 1. EU Health and Consumer Protection Directorate-General, Scientific Committee on Emerging and Newly-Identified Health Risks (SCENIHR) p. 17. 2. REACH substance evaluation at European Chemicals Agency website (echa.Europa.eu) for chemical listing CAS No. 3319-31-1 (TOTM). 3. Paul Daniels, SpecialChem, Alternatives to Phthalate Plasticizers, Slide 13, 2014.
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ROBOTICS
G
TEAM SPIRIT
E Healthcare, manufacturer of medical technologies and services for the healthcare industry needed to transform an ageing packaging line for its signature Drytec product, a generator of the injectable radio nuclide TC99m used in hospitals all over the world for patient diagnostic imaging.
When GE Healthcare was looking to transform a packaging line, partnering with a robotic company proved highly successful
The company decided that it needed a new handling and packaging solution. Its existing packaging facility was struggling to keep up with demand, with the short lifetime of the product requiring a 24 hour turnaround to ensure timely patient care. Packing line components were becoming outdated and/or unavailable and required extensive modification to repair or upgrade. GE Healthcare needed a quick and efficient way of increasing the production output and at the same time ensuring safety due to the radioactive composition of the product. The company realised it had to respond rapidly to improve its packaging line processes without disrupting current operations.
The solution GE Healthcare partnered with Fanuc UK to build and install a reliable and safe solution for its packing line. Fanuc designed the complete solution at its facility in Rugby which was used to build and test the packing line, including fully mocked-up shield walls, for an extensive FAT (Factory Acceptance Test). The test demonstrated functionality of all robotic end-effectors, product throughput time and the software managing the scheduling and product tracking through the system to despatch and shipping. For the above mentioned software, Fanuc commissioned Solcom, provider of industrial software and systems, to deliver this aspect of the project. Validation of the system was completed in-house. Once the automated packaging process was successfully installed and operational, the finished Drytec products were collected from the manufacturing production line and loaded onto the packaging line in stillages. The packing materials were pre-loaded onto the line during non-production, after which the packing process ran automatically, packing the Drytec generators, associated ancillary box and paper documentation into the individually labelled shipping boxes, followed by palletising and wrapping. Shipment inventory documents are created for each pallet. A range of Drytec generators are available, with each order individually manufactured and packed with appropriate literature for the destination country. A total of six Fanuc robots were integrated into this solution. The software provided by Solcom, working in conjunction with visual barcode reading and OCR was integrated into several stages of the packaging process ensuring that only the correct product could ever be shipped to a given address, whilst managing and prioritising delivery for clients around the world.
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Workflow sequence
Key: Robot 1: M-710iC/20L six axis Robot 2: M20iC six-axis Robot 3: R-2000iB/165F six-axis Robot 4: M20iC six-axis Robot 5: M-710iC/70 six-axis Robot 6: M-410iB/140H five-axis
Benefits Previously the unreliable automation caused a high degree of manual intervention to the line, increasing operator radiation dose rates. Also occasional failure of the plant for even a few hours directly impacted supply to the end customer, resulting in cancelled patient appointments. Using robots to automate the packaging vastly improves the line reliability and reduces risk. The automated solution ensures a consistent flow in the packing line with zero outages, and guaranteed timely delivery of the product to the end user. At the same time, reductions in manual handling reduced operator dose rate, and improved working conditions.
Outcomes
Since the installation of the plant in January 2014 manual handling and rework has gone down from 10% to 1% and much needed capacity for growth has been created; with the ability to produce in excess of 500 generators per eight hour shift. Robert Scivier, technical authority for controls & instrumentation, GE Healthcare said: ‘We chose to work with Fanuc due to its reputation as the world’s leading provider of automation solutions. Fanuc was able to supply us with a safe and reliable end-to-end packaging process and at the same time support and maintain existing operations. The new robotics packaging line supplied represents a significant step forward for our supply chain. It has delivered major improvements to our manufacturing operation through improved reliability and the ability to meet regulatory expectations and safeguards, whilst reducing manual handling/ dose uptake for operators and ensuring capacity for future growth. In short, it has been a major success.”
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WELDING
Joint
forces
According to LPKF laser plastic welding offers three main advantages: it is economical, it delivers assured quality and it opens up novel product layouts
M
edical microfluidics demand high specifications, precision, cleanliness and a high quality joining method. The laser welding of thermoplastics is well established and goes back to approximately 2000.The technology joins together a lasertransparent and a laser-absorbent material. The laser beam passes right through the upper joining partner to hit the welding zone where it is absorbed by the lower joining partner. The lower part of the weld seam is heated up until it melts.
Thermal conduction passes the energy onto the upper joining partner which warms up to such an extent that the molecular chains diffuse in the affected areas. An adhesive bond is created when the parts have cooled down. The strength of a laser weld seam is similar to that of the solid material and almost achieves a weld factor of 1. This technology is also known as laser transmission welding.
In principle, it is possible to safely weld almost all thermoplastics as long as the two joining partners melt in the same temperature range. This is rarely a problem when the plastics are made of the same material. Common plastics are usually adequately transparent to laser beams in their natural form and therefore suitable for use as the upper welding partner. Pigment particles or soot particles are added to the plastic forming the lower joining partner to increase its absorption rates. The laser sources used in this technology usually have laser wavelengths in the near infrared range (NIR) – between 800 to 1100 µm – and power outputs of between 30 and 600 watts. Modern, low-maintenance diode or fibre lasers have replaced the laser sources used when this technology was first developed and which required a great deal of servicing. Because the laser beams are in the non-visible range, it is also possible to weld plastics which appear optically opaque. This increases flexibility: in a large number of detailed test series, LPKF has determined the optimal laser parameters for different combinations of plastics and colours.
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In principle, it is possible to safely weld almost all thermoplastics as long as the two joining partners melt in the same temperature range.
Comparison between different welding methods All of the methods for joining together plastics have strengths and weaknesses. The cost of modern laser welding systems is similar to those of other methods. The laser technology scores when it comes to tool costs, consumables costs and expenses associated with wear and tear. Because there are no significant mechanical, dynamic or thermal stresses on the welding system and components, it is usually possible to use simple clamping tools and component holders. This and the software-controlled laser welding paths, enable economic production flows to be achieved, even with a range of different components.
Laser welding systems are almost maintenance-free, and can also undertake process monitoring functions. The laser system can identify irregularities during the ongoing process and guarantee production quality by separating good parts from bad parts. Moreover, all of the parameters can be recorded for end-to-end tracking and tracing. The properties of the products demanded by manufacturers are another means of selecting the best joining method. A separate tightness test can be dispensed with during laser welding thanks to the inline process control of the laser-welded components. For sophisticated components the microstructural quality of the weld zone is an important aspect. Unlike vibration welding methods, no particles are created during laser transmission welding, no additives are added to the components, and the weld seams satisfy even the highest optical specifications. Laser transmission welding has become the technology of choice when applications demand higher quality welds and when they involve sensitive components. The important arguments for laser welding technology are the project-specific costs – which can be up to one third lower – the high degree of flexibility of the systems, the integrated process control and the high yields of good parts – even if the quality of the upstream products fluctuates.
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Laser welding in microfluidics applications Patients used to wait several days for laboratory results after visiting their doctor – analysis of blood is now done by mini laboratories within a few minutes.
Seamless transition: Laser transmission welding has become the technology of choice when applications demand higher quality welds and when they involve sensitive components
This is one of the areas of application of microfluidics. Fine, highly precise channels are specified for microfluidic systems. These channels have to be sealed. Transparent material is required for many applications because the reactions are evaluated optically. A special laser welding method also provides the necessary technology for this as well. LPKF ClearJoining technology uses a laser with a wavelength of 2 Âľm to penetrate both joining partners and focus the laser energy precisely along the welding horizon. The slight absorption value of the plastic is enough to create a reliable weld.
Comparison of the strengths and weaknesses of standard methods for joining plastic components
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CAD/CAE SOFTWARE 3D PRINTING ADDITIVE MANUFACTURING MOULDING & TOOLING MACHINE TOOLS METROLOGY INSPECTION
28 SEPT - 29 SEPT 2016
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MD&M EAST
An Apple a day...
B
illed as the ‘medtech powerhouse’ MD&M East will cover the full advanced manufacturing cycle, from conception to distribution. More than 900 suppliers will showcase innovation for the From June 14-16 medical sector.
at the Jacob K Javits Convention Center, New York, MD&M East will provide the latest advances and thought leadership in medtech
The expo and conference is the gathering point for more than 500 leading medtech suppliers and manufacturers, including 3M, Abbott, Nypro Healthcare, PhillipsMedisize, and Stratasys.
Visitors to MD&M East can learn more about every aspect of the medical device development process to help solve design, engineering, prototyping, and manufacturing challenges. There is the opportunity to meet new suppliers from across the design and manufacturing production cycle as well as the ability to uncover the latest medical technology. The event allows visitors to make informed buying decisions, differentiate their solutions from the competition and keep ahead of regulatory issues. Organisors of the event have designed the expo and conference to expand and deepen the visitors’ medtech knowledge. There will four medical-specific learning tracks covering Market Value and
Consumer Health; New Technologies; Big Data; and Mobile Product Risk. An MD&M East conference pass also admits visitors to additional conference sessions covering packaging – explore how the latest medical packaging is designed to ensure patient safety and can inspire purchase. As well, discover how smart manufacturing processes are redefining every aspect of the manufacturing industry.
Expertise on offer “All attending manufacturing professionals will have the chance to start each day of the conference with inspiration from keynote speakers, highly relevant across all industry verticals,” said Stephen Corrick, senior vice president and portfolio director of UBM Americas’ Advanced Manufacturing group. “We’re honoured to present top leaders to share their own transformational business experiences and success stories to help attendees realise their potential.” Inspirational, aspirational and technical keynote speakers will share how manufacturing technology is accelerating business. Each morning the event will open with a thought-provoking keynote address by one of the industry’s biggest thinkers in the categories of inspiration, aspiration and technical strategies. For the first time, the keynote presentations will be open to expo pass holders across all industries. Keynote speakers include:
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Day 1 Inspirational: Dr Leroy Chiao - astronaut and pioneer in commercial spaceflight In his presentation, Preparing Your Business for the Future – Technology Innovation Trends, Dr Leroy Chiao will share stories of his time in space and the implications on technology and business. He’ll explain how organisations can take advantage of the next technological phase – which may include thought-controlled computer augmentation, sensors that can identify you instantly and personalised medicine tailored to your genetics.
Day 2 Aspirational: Martin McCourt, former CEO of Dyson As the former CEO of Dyson, Martin McCourt has spent more than 40 years working at the heart of Britishbased manufacturing, design and marketing In 2019 he was named UK Business Leader of the Year. He has devised and implemented a strategy that transformed the company from a single product, single market producer into one where 80% of the business comes from over 60 markets around the world. In his presentation, Iterative Development: Former CEO of Dyson Reflects on his Experience, McCourt will share advice and guidance for success, and his passion for nurturing the next generation of entrepreneurs to become leaders through his straightforward way of thinking. Kevin Mitnick, the world’s most famous hacker, will reveal the latest threats to prove the importance of cyber security. As manufacturing and mobile health rely increasingly on machine-to-machine communications and the Internet of Things to power connected devices, security has become a top priority across the industry.
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The film: Elysium The year: 2013 The budget : $115 million Box office takings: $2 86.1 million Rating: 6.6/10 IMDB Leading ligh / 67% Rotten ts: Tomatoes Matt Damon , Jodie Fost er, Sharlto Braga, Dieg Copley, Alic o Luna, Wag e ner Moura Written an and William d directed Fichtner by: Neill Bl omkamp
MEDTECH at the movies
Synopsis
Space-age medical devices meet a social commentary on the healthcare sector
ELYSIUM
The public perception of our industry is in part shaped by Hollywood’s depictions of the devices, companies and individuals that keep the machine moving. This issue, David Gray reflects on Elysium’s treatment of the medtech sector
In the year 2154, humans either live on the affluent space habitat called Elysium, or poverty-stricken, overcrowded earth. When the film’s protagonist Max falls gravely ill, he must find a way to get to Elysium and receive first-class healthcare.
Devices
The device that forms the backbone of Max’s mission is the Med-Bay. Similar in appearance to a modern day CT or MRI scanner, the Med-Bays are a one-size-fitsall cure for any ailment. What’s interesting is that to use the Med-Bays, patients have to be tattooed with a unique ‘barcode’, giving the Med-Bay authorisation to treat them. In reality, we probably won’t have to wait till 2154 for true patient barcodes to be a reality. The UK’s former director for patients and Information, Tim Kelsey famously said ‘Every patient needs a barcode’. The increasing connectivity of our medical devices makes digitally enabled patient identification a logical progression for our healthcare systems. There seems no limit to what the Med-Bays can cure. We see them reverse radiation poisoning, cure acute lymphoblastic leukaemia, and conduct facial reconstruction surgery – which comes with the added bonus of making the patient appear more youthful. Wishful thinking? Absolutely. But that’s the kind of thinking that initiated the Qualcomm Tricorder
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Matt Damon stars in this sci-fi thriller about the future of the medical and healthcare sectors (image credit: Tinseltown / Shutterstock.com)
Finally, data plays a significant role in the healthcare systems of the two respective worlds. Max is implanted with a data storage device, enabling him to download a programme designed to overthrow the current establishment in Elysium. Many of the characters in fact are programmed with ‘medical implants’, which appear to be linked to the aforementioned tattoos.
Portrayal of the sector Competition back in 2012. Qualcomm set the world a challenge: a race to invent a device that can correctly diagnose 13 health conditions, independent of healthcare workers or facilities. The world of science fiction has often been described as ahead of its time – Star Trek and Elysium were both franchises that delved pretty deep into the realms of plausibility. Exoskeletons are also prominent throughout the film. Yet again, Elysium describes a futuristic technology. But powered exoskeletons such as the ones used in the movie are already in use in healthcare settings. Perhaps the most notable example of this is the hybrid assistive limb (HAL) developed by Japanese robotics company Cyberdyne, in partnership with Tsukuba University. Certified ISO 13485, the device is used in Japanese hospitals for movement rehabilitation purposes. However, since the device can also assist users in lifting far heavier weights than they alone could it was also used in the cleanup operation following the Fukushima nuclear disaster. Powered exoskeletons like this typically work by intercepting biosignals on the skin, sent from the brain to the muscles. These biosignals register as instructions and assist the user’s movement.
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It’s not just the medical sector that comes under fire in Neill Blomkamp’s movie. Crime, poverty and labour all look pretty bleak on earth, whilst on Elysium there’s no crime, everyone has a swimming pool, and nobody really seems to contribute. But the real struggles in the film come in the form of a desperate need for healthcare. Healthcare for the masses, for the poisoned Max, and healthcare for his friend’s daughter, who’s dying of leukaemia. Their social status denies them this privilege. They have hospitals on earth, but they look exactly like real hospitals of 2016 – albeit less hygienic. Medtech on earth has not advanced. If you’re fortunate enough to live on Elysium however, there are no hospitals. Every citizen simply has access to the super-fast MedBays dotted around the habitat. This film strongly alludes to the exclusive nature of certain healthcare systems, and their knock-on effect on innovation in medical technology.
Why you should see this film
While its not-so-subtle message is a little too on the nose for my liking, the movie nonetheless presents a hopeful vision of a future where medical technology is even more powerful than pharmaceuticals in curing disease.
NEC BIRMINGHAM, UK | 26-28 SEPTEMBER 2017
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We know process is the absolute key to assuring that we deliver upon our customers’ expectations, the first time and every time. That’s why our people are all about process. In fact, our process requirements apply not only to manufacturing and quality SOPs, but also to our customer facing operations such as Program Management and Design and Development engagements, ensuring our customers benefit from a repeatable and scalable model. So, when you work with Phillips-Medisize, you can be certain we’ll exceed your highest expectations the first time and every time.
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