MPN Eu Issue 40 by MPN Magazine

MEDICAL PLASTICS news

+ THE BEST OF 2017â&#x20AC;&#x2122;S MEDTECH WORLD WHY YOU NEED TO BE AT COMPAMED FOCUS ON DIGITAL HEALTH

Brilliant Mind

Franceschetti takes the smart approach to TPE extrusion ISSUE 39

Nov-Dec 2017

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CONTENTS Novemeber-December 2017, Issue 39

Regulars

Features

5 Comment Lu Rahman wonders if we should be so trusting

18 Headline acts Lu Rahman picks her key moments of 2017

37 Deal or no deal Lu Rahman looks at some of the recent MA activity in the industry

6 News focus Will new FDA regulations lead to increased innovation from device manufacturers?

25 Making the connection Eastman explains how its technology collaborations begin and succeed

39 Reach the PEEK Invibio Biomaterial Solutions, looks at composite polymer implants

8 Digital spy 11 News focus Where are we with UDI compliance?

27 Doctor doctor Lu Rahman looks at how healthcare professionals are leading the digital health revolution

14 Cover story Franceschetti explains how it takes a smart approach to extrusion

32 Going going gone Evonik Health Care details how medical device companies can use bioresorbable materials

54 12:2017

35 The soft approach Soft robotics ďŹ rm, qbrobotics has boosted protoyping eďŹ&#x192;ciencies using 3D printing

42 What the worlds needs now Why the medical device sector needs to head to Medica and Compamed 47 Chip shot Lab-on-a-chip technology is showing increasing potential for the healthcare sector, says Lu Rahman

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CREDITS

EDITOR’S

group editor | lu rahman

comment

deputy group editor | dave gray reporter | reece armstrong advertising | gaurav avasthi 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 and Europe: FREE North America: £249 Rest of the world: £249 subscription enquiries to subscriptions@rapidnews.com

Medical Plastics News is published by: Rapid Life Sciences Ltd, Carlton House, Sandpiper Way, Chester Business Park, Chester, CH4 9QE T: +44(0)1244 680222 F: +44(0)1244 671074 © 2017 Rapid Life Sciences Ltd While every attempt has been made to ensure that the information contained within this publication is accurate the publisher accepts no liability for information published in error, or for views expressed. All rights for Medical Plastics News are reserved. Reproduction in whole or in part without prior written permission from the publisher is strictly prohibited.

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ISSN No: 2047 - 4741 (Print) 2047 - 475X (Digital)

Learning to trust: should we let down our medtech guard?

y daughter is big on internet safety. Most young people have a far better sense of how to stay safe online than the generation that produced them. I know I can be a bit slap dash when it comes to protecting my online profile and digital footprint. It made me wonder how far we should trust what we do online – where’s the balance between benefitting from the positives to be gained from the digital world – in particular digital medical tech – and the need to safeguard ourselves? Trust is interesting. A YouGov survey in the UK back in 2014 showed that two thirds of British people trusted the authors of Wikipedia entries more than journalists (by the way, we’re a very trustworthy bunch on MPN). In a Readers Digest survey in the US, 77% of people said they trusted their own doctor and interestingly, doctors topped the poll for the most trustworthy profession. Society has shifted from completely human interaction to learning to accept the world of online transactions. Learning to trust that connected medical devices can benefit us, has also been learned. Having faith in the world of digital devices is no mean feat. Issues of data security aren’t going away yet we recognise the benefits of connected medical technology. Devices that allow treatment in the home, that connect with healthcare professionals for the analysis of results, or allow us to administer drugs without leaving the comfort of our own homes, have been welcomed. And why not? Who wants to spend time in a clinic or on ward instead of at home?

We have faith in the medical profession that recommends devices, we have faith in brand names and we have faith in technology designed to keep us healthy. But should we be so trusting? Recently half a million pacemakers from Abbott were recalled amid fears that they could be hacked and affect the user’s heartbeat. Stories like this make us realise how vulnerable we can be when we bring the internet and medical devices together. Of course, medical device manufacturers are working to ensure products are increasingly hard to hack. Robert Ford, the executive vice president of medical devices at Abbott, told the Guardian: “All industries need to be constantly vigilant against unauthorised access. This isn’t a static process, which is why we’re working with others in the healthcare sector to ensure we’re proactively addressing common topics to further advance the security of devices and systems.”

“

Society has shifted from completely human interaction to learning to accept the world of online transactions

Do we trust the words of people like Ford? There’s probably a balance to be found. We’re unlikely to turn our backs on connected devices but a little caution may be a sensible thing. As for me, I’m sold on the positives that digital medtech has to offer and the quality of life it affords us all. That’s the bottom line. One day security issues will be distant memories as the medical device sector, healthcare professionals (who of course are very trustworthy) and software experts makes us trust in them completely.

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NEWS FOCUS

New FDA guidance aims to aid medical device development

on the outputs of this newly qualified tool as part of their development plans. Innovators can trust in advance that the agency has already found the outputs of these measures to be reliable.

he FDA has released new guidelines to aid medical device regulation and assess the effectiveness of cardiovascular products. According to a statement from FDA commissioner Scott Gottlieb, the organisation is setting out new medical device development tools that will measure the safety and performance of devices so they provide the required benefits to patients.

The FDA says it expects to evaluate and qualify more medical device development tools in the coming months. One area in which it feels there may be opportunity is wearable technologies as it believes these tools have the potential to provide fundamentally better ways of measuring clinical outcomes, like how a device or even a drug affects outcomes that relate to physical performance or the function and output of different organ systems.

Gottlieb outlined how the aim was to enable patients and providers to have efficient access to new and innovative medical products that meet the FDA’s gold standard for safety and effectiveness. “We’re advancing these goals as part of the Medical Innovation Access Plan that I announced earlier this year,” he said. As one part of that effort, the FDA is announcing some additional steps to promote beneficial medical device innovation. The FDA knows that medical device technology evolves quickly. “Often it’s the case that small modifications help provide incremental but meaningful improvements to products. Over time, these cumulative advances are consolidated into more noticeable advances in the performances of different technologies. Therefore it’s important for the FDA to enable innovators to have the ﬂexibility to efficiently make these kinds of small modifications. At the same time, the FDA needs to establish modern tools and benchmarks for measuring the safety and performance of devices to make sure they’re delivering the expected benefits to patients,” said Gottlieb. To achieve this the FDA has taken steps towards these goals: This first measure is a medical device development tool (MDDT) to provide a more objective platform

for developing devices in a key area of medicine – cardiovascular health. “Fostering the creation and validation of development tools that can be used to provide more efficient and accurate ways to measure risk and benefit, as part of the medical product development process, is a key goal of the FDA. At the FDA, we’re undertaking a comprehensive policy effort to facilitate the development and validation of these kinds of medical device development tools,” said Gottlieb’s statement The MDDT is a 23-item questionnaire that measures health information that is reported directly by patients with heart failure. It can be used to measure a heart failure patient’s health status, including clinical symptoms and the physical and social limitations caused by this condition. It has the potential to help engineers designing heart failure devices to more efficiently and accurately quantify how much their device could actually improve a patient’s quality of life. By qualifying the tool under the FDA’s new, voluntary program, it will make it easier for product developers to rely

The FDA has also released three new guidance documents related to medical devices. The first is a draft guidance delineating the FDA’s new ‘Breakthrough Devices Program,’ which was created by the 21st Century Cures Act passed by Congress last year. Building on the Expedited Access Pathway (EAP) program, this new scheme is intended to help patients more quickly access certain devices that more effectively diagnose or treat life-threatening or irreversibly debilitating diseases or conditions, such as technologies that have no alternative or that offer a significant advantage over FDAcleared or approved alternatives. The program would enable a more agile pre-submission process for breakthrough devices. There are also two additional piece of guidance that will help innovators determine when they need to submit a new 510(k) prior to making a change to a legally-marketed device subject to premarket notification (510(k)) requirements. These policies will help innovators introduce iterative improvements that can improve a product’s safety and performance by establishing a clearer line regarding when the FDA needs to review and clear these changes in advance.

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DIGITAL

spy

HARD AND FAST:

SUPER-ELASTIC SURGICAL GLUE STICKS IN VIVO AND WHEN TISSUES ARE MOVING

To repair ruptured or pierced organs and tissues, surgeons commonly use staples, sutures and wires to bring and hold the wound edges together so that they can heal. However, these procedures can be difficult to perform in hardto-reach areas of the body and wounds are often not completely sealed immediately. They also come with the risk that tissues are further damaged and infected. A particular challenge is posed by wounds in fragile or elastic tissues that continuously expand or contract and relax, like the breathing lung, the beating heart and pulsing arteries. To remedy some of these problems, Harvard’s Wyss Institute biomedical engineers have developed a range of surgical sealants that can bond tissues to stop leakages. Yet, “currently available sealants are not

www.ge.com

Healthcare is claiming an industry first with its patient-assisted mammography device that puts women in control of the procedure.

wyss.harvard.edu

Only human: THE MEDICAL DEVICE THAT PUTS WOMEN INCONTROL

TECHNOLOGY UPDATE

new study has shown that a highly elastic and adhesive surgical sealant can effectively seal wounds in shape-shifting tissues without the need for common staples or sutures.

DIGITAL TECHNOLOGY

suitable for most surgical applications and they do not work alone without the need for suturing or stapling because they lack an optimal combination of elasticity, tissue adhesion and strength. Using our expertise in creating materials for regenerative medicine, we aimed to create an actual fix for this problem in a multi-disciplinary effort with clinicians and bioengineers,” said Ali Khademhosseini, associate faculty member at Harvard’s Wyss Institute for Biologically Inspired Engineering. The researchers demonstrated that a sealant, based on elastin — a human, resilience-imparting protein present in all elastic tissues such as the wall of arteries, skin, and lungs — can be photochemically tuned to effectively seal incisions in arteries and lungs of rats and to repair wounds in the lungs of pigs, all suture and staple-free. The potential applications include treating serious internal wounds at emergency sites and in war zones, as well as improving hospital surgeries.

The Senographe Pristina Dueta has received FDA 510(k) clearance. It has been designed with a remote control that allows women to manage their own compression during the examination. “Engineered by a team of women for women, GE Healthcare has transformed mammography with the creation of patient-assisted compression to decrease pain associated with the exam, improve patient experience and increase outcomes for breast cancer screening which we know saves lives,” said Agnes Berzsenyi, president and CEO of GE Healthcare Women’s Health.

women to control the application of compression to minimise the perceived pain and discomfort often associated with a mammogram. “This is a new age in breast imaging,” said Dr. Kathy Schilling, medical director of the Boca Raton Regional Hospital’s Christine E Lynn Women’s Health & Wellness Center and radiologist. “Patients who used the remote control said the exam was more comfortable and they were visibly more relaxed. Any breast radiologist knows that when patients are relaxed, we are able to get better images and better images lead to a more confident diagnosis.”

In traditional mammography, the technologist performing the exam compresses the patient’s breast, often causing discomfort. Patientassisted compression allows

DIGITAL NEWS

Device companies receive FDA warning letters

www.raps.org

ccording to the Regulatory Affairs Professionals Society (RAPS), the FDA has sent warning letters to two medical device manufacturers. The companies are reported to be Florida-based UVLrx Therapeutics, and ELITech Group SAS based in France.

and began treating subjects”.

Zachary Brennan says that an inspection carried out at UVLrx Therapeutics “to assess a clinical study the company was conducting found that among other violations, UVLrx received institutional review board (IRB) approval to enroll 1,000 subjects for one trial protocol but 3,063 subjects were actually enrolled. FDA also found that at least 10 clinical investigators were not approved for a study, though they received investigational devices

In regards to the ELITech Group, it was found that the company “failed to adequately establish and maintain procedures for CAPAs and did not have documented instructions covering the practice of postponing CAPAs”.

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Brennan also reports that the company is said to have failed to have kept up with documentation, apply proper device labelling or “include the investigational device caution statement”.

It was also reported that the company had failed to look into complaints regarding leaking units and rusty residue.

DIGITAL SPY

DIGITAL NEWS www.europlaz.co.uk

In hand: Fingerprinting tech deal agreed

-based Intelligent Fingerprinting has signed a three-year deal with UK medical device manufacturing specialist Europlaz to produce critical components for the innovative cartridge element of the Intelligent Fingerprinting Drug Screening System.

its small, ergonomically-designed and tamper-proof single use cartridge for drug screening. Key elements addressed by Europlaz in the process include precision moulding to create a ‘living hinge’ that supports the cartridge’s buffer clip, as well as a number of high quality features for the cartridge’s secure sliding cover.

The Intelligent Fingerprinting system works by analysing fingerprint sweat on a single use collection cartridge. Sample collection takes a few seconds and can then be used to screen for the four main drug groups – cocaine, opiates, cannabis and amphetamines – simultaneously. The new fingerprint drug test – which has been fully trialled and is now available to order – has applications across a variety of screening scenarios, including drug rehabilitation programmes, workplace applications, criminal justice and for use by coroners. The device’s performance is highly dependent on two specialised features, its anti-tamper sliding cover which protects the fingerprint from contamination after collection and the sealed reagent release mechanism. Europlaz is a contract medical manufacturer specialising in the production of the highest quality plastic injection moulded components, sub-assemblies and finished medical devices. The company has worked closely with Intelligent Fingerprinting on the manufacturing development of

“Our ground-breaking technology depends on the highest standards of quality and accuracy, and Europlaz has already proved to be an essential partner in the design and development of our innovative, tamper-proof fingerprint collection cartridge,” commented Dr Jerry Walker, Intelligent Fingerprinting’s CEO. “Europlaz brings proven injection moulding skills and impressive clean room facilities to our partnership, and we now look forward to extending our relationship as we scale up our manufacturing following the full validation and commercial introduction of our fingerprint-based drug screening system.”

Money for old smoke THE DEVICE HELPING ASSESS THE LINK BETWEEN FINANCIAL INCENTIVES AND STOPPING SMOKING

How does this work exactly? Manufactured by Bedfont Scientific, the Smokerlyzer is a breath analysis medical device used to help people quit smoking. It will be used in a clinical study at the Maastricht University to investigate whether or not a reward makes smoking cessation more effective.

Welcome return:

TOPAS HEADS BACK TO COMPAMED

www.velox.com

The project, CATCH (Continuous Abstinence Through Corporate Healthcare) will take several Dutch companies partaking in Smoking Cessation programmes, however only half of the subjects will receive gift certificates for their efforts. Have studies like this been done before? Yes. Back in 2015 the UK’s Daily Mail reported that two pieces of research suggested that financial incentives could help improve health. One study offered pregnant women £400 to stop smoking and found that this led to an increase in those who kicked the habit compared with those that hadn’t been offered anything.

elox has announced that it is returning to Compamed after several years of absence (hall 8B, stand L31). Along with partners Topas and IPC, both first-time exhibitors, the company says it will be presenting innovative and highly specialised plastic and compound solutions for the medical and pharmaceuticals industry at Compamed.

“Over the past editions we have been successful in establishing valuable and long-term contact with customers and suppliers alike. So this year we are returning with two new partners and our own stand.”

POINT

Is it a medical device? Apparently so. Called the ‘Smokerlyzer’, it is being used to study the effectiveness of financial incentives and smoking cessation.

EVENT UPDATE

“Compamed has always been a key trade show for the medical plastics sector,” confirms Siobhan Bastiansen, market manager medical plastics at Velox.

talking

So what will the Smokerlyzer do? It’s a series of carbon monoxide (CO) monitors that measure the harmful amount of CO that is inhaled from smoking. This can show how much a patient has been smoking, giving smoking cessation advisors an idea on the level of dependency that the smoker has. Topas Advanced Polymers manufactures cyclo-olefin copolymers (COC). This highly transparent engineering plastic is ideally suited for pharmaceutical primary packaging as well as medical and diagnostic articles. The material is designed to be especially pure, and offer excellent barrier protection and outstanding biocompatibility.

What does the company say about the product? Jason Smith, managing director at Bedfont, says the Smokerlyzer has been used globally for over 30 years now to help people quit smoking and that it is quick, easy and non-invasive making it a valuable tool to monitor a quit attempt, as well as being a motivational visual aid to encourage the user to quit smoking. Smith hopes that the research being carried out by Maastricht University can help to find new methods and incentives to help people quit smoking successfully.

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NEWS FOCUS

Warren Stacey, Prisym ID looks at best practice for UDI compliance and offers an examination of UDI implementation to date

UDI compliance: Where are we?

early four years after the FDA set out its framework for establishing a unique device identification system to identify medical devices through their distribution and use, implementation is well over halfway and there is little time remaining before its compulsory introduction. The system means that by 2020 most medical devices will need to include a Unique Device Identifier (UDI) in human and machinereadable 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 implications for medical device companies are significant. Assuring UDI compliance requires

a major review not only of an organisation’s labelling capabilities but also how it connects with all the other divisions that impact supply chain operations. Furthermore, the journey towards UDI compliance requires an enterprise-wide program of change management to ensure the requisite infrastructure is in place. It’s a journey that for many manufacturers has proved to be a challenging one. UDI: Its meaning & purpose? 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

The FDA’s definition of a UDI and its guidelines are complex and mean that, for many companies, managing the transition to UDI compliance can be a challenging process. Critically, the implications for labelling 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. Labelling at the center A survey conducted last year by Prysim ID highlighted 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 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 labelling 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 was their biggest challenge, while 9% reported issues adding a UDI

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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 labelling. 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 labelling 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. Conclusion 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. 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 the remaining medical device manufacturers who have yet to implement UDI to ensure they have the optimal labelling solution in place as they approach the final 2020 FDA deadline.

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NEWS FOCUS

How can medical device manufacturers deliver future innovation in medtech?

he medical device sector is an integral part of the healthcare industry, and has seen an unprecedented growth in innovative and improved technologies that Roger Mazzella, delivers benefits such as reduced Qt Company discusses patient recovery time, lower cost developing and of instruments, and more. The regulating innovative Internet of Things (IoT) is one of medical technologies those technologies – and Gartner of the future predicts that 8.4 billion connected things will be in use worldwide in 2017, and that total spending on endpoints and services will reach almost $2 trillion this year. Meanwhile, the Internet of Medical Things (IoMT) market, an emerging sub-sector of the IoT, stood at $22.5 billion in 2016, and is expected to grow at an impressive compound annual growth rate of 26.2% to reach $72 billion by 2021, per analyst and research firm Frost & Sullivan.

In the United States and the European Union (EU), strict compliance with regulations and guidance is a current solution, and many organizations (government, public and private) work together to make this happen. For example, the Advanced Medical Technology Association (AdvaMed) is a trade association that leads the effort to advance medical technology to achieve healthier lives and healthier economies around the world. The Massachusetts Medical Device Industry Council (MassMEDIC) is an organisation of medical device manufacturers, suppliers and associated non-profit groups in Massachusetts and the surrounding region. AdvaMed and MassMEDIC work closely with national and international organisations such as the US. Food and Drug Administration (FDA) and the EU to advocate and promote policies directly from the medical community.

AdvaMed is currently involved with the FDA’s Digital The development of medical devices and Health Precertification (PreCert) Pilot Program. The accompanying technologies takes time and impetus for this scheme is the fact that traditional money, as many innovative products regulatory processes for high-risk medical are new and need to go through the devices are slow and methodical. With rigours of in-country certification and the help of AdvaMed advisors, however, market clearance processes. These the FDA realised that this traditional devices, such as the latest iterations of The development regulatory approach for higher-risk, pacemakers, insulin pumps and blood of medical devices hardware-based medical devices is pressure monitors, will eventually come well-suited for software products. and accompanying not into contact with patients and sensitive Software evolves faster than hardware, information – and, in severe cases, life- technologies takes and therefore has a more iterative design, or-death situations – on a daily basis. time and money development and validation cycle. The As a result, there are regulations and FDA PreCert Program will help better processes to ensure these technologies regulate these technologies by learning, reach consumers only after passing a adapting and adjusting key elements in rigorous battery of clinical trials – which real-time. The goal: to allow software is why healthcare is the second-most regulated iterations and changes to occur in a timely fashion, industry around the world (aviation is number one). and ensure high quality medical products and software. However, new developments and the continued rise of new technologies like the IoMT have created more The IoMT is another new development that will impact challenges than ever for medical device developers, the industry as a whole. Due to the requirements of bringing issues such as cybersecurity and data this ecosystem, there are specific considerations, integrity to the forefront. Looking ahead, what can be including cybersecurity and data integrity, that done to keep the health and well-being of patients organisations such as medical device manufacturers the top priority? should make – otherwise they not only could lose out on business opportunities, but could also put their customers at risk. To accommodate these considerations, the software powering medical devices has become more complex, hence the need for initiatives such as the FDA PreCert Program. The medical industry is evolving rapidly, and Qt is at the forefront of industry professionals who aim to inﬂuence the direction of technology innovation, as well as the standards and requirements that govern the sector on every level: local, state, national and global.

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ere at Francesco Franceschetti Elastomeri (FFE), we are known as a leading producer of TPE/TPO compounds that are certified for food contact and medical use – that’s our focus today as well as the driving force for the future. Since their first appearance on the market, TPEs have mainly been used in injection moulding and have experienced some difficulties gaining ground in the extrusion world, as this has traditionally been dominated by vulcanised rubber on the one hand and plasticised PVC on the other. However, in recent years there has been a strong tendency to reconsider TPEs as suitable candidates for a number of extrusion applications – a trend favoured mainly in the fields of drinking water and medicine as a result of more stringent hygienic requirements. In the medical field, the dominant position of plasticised PVC as a raw material for the production of medical devices stands as a point of reference to all market newcomers like TPEs, which must conform to many common processing techniques applicable to PVC (eg. solvent bonding) or enable new applications and/or new alternative processes to be created in order to carve out their own market space.

FFE is committed to developing and producing new TPE solutions for strongly-regulated applications and for both present and future challenges. The company’s most recent developments have been focused on extrusion grades for many applications in the medical field, for drinking water and other relevant industrial applications. Our current projects are dedicated first and foremost to Marfran TPEs for drinking water applications and to Marfran. Med medical compounds, with a particularly strong focus on solvent-bonding products (a complete revolutionary solution for a TPE that until only recently could not be bonded with a solvent). By working closely with our raw material suppliers and investing in new process technologies, FFE uses the latest innovations to identify new material combinations and develop new possibilities. Below right | PERFECT PARTNER: The safe and non-toxic properties of TPEs make them an ideal component in the design of medical products Below | GROUP ASSETS: FFE’s TPE portfolio includes many medical extrusion grades suitable applications such as pipes for peristaltic pumps, urinary catheters, surgery catheters and respiratory-aid devices

Medical compounds Medical applications are a highgrowth TPE sector with major applications in tubing, catheters, intravenous systems, resealable membranes and films. In the medical industry, the demand for safe and halogenfree polymers such as styrenic block copolymer-based materials is currently on the rise. The safe and non-toxic properties of TPEs make them an ideal component in the design of medical products, for which superior performance levels and safety are required. TPEs combine ﬂexibility with high performance, while also complying with many food and skin contact regulations due to their inherent low toxicity. When selecting TPE for medical applications, manufacturers can either choose food contact or medical grades. The current trend seems to be swinging towards medical grades, but awareness about the similarities and differences between both grades is necessary in order to make the right choices. Food contact raw materials have to be cleared by Regulation (EU) 10-2011, stating whether they are a substance with specific migration limits (SML) or a dual use substance. Medical raw materials have to be compliant with European Pharmacopeia and have their biocompatibility certified according to ISO 10993 and USP class VI – which means higher costs.

The transformation processes for Marfran.Med are carried out in a newly dedicated cleanroom, which is compliant with ISO 13485; ISO 7 class, according to ISO 14644-1, and Class 10,000 equivalent, according US FED STD 209E. The cleanroom is highly automated, subject to strict cleaning procedures and to optical checks for quality control. That means more extensive clean down and line clearance procedures, with the guarantee of process change control and that production only takes place on dedicated lines. As a leader in the production of compounds based on thermoplastic elastomer compounds (TPE/TPO based on SBS and SEBS), FFE has a full range of TPE Marfran. Med solutions for medical applications. Extrusion TPEs for medical application We have seen an interest in substituting PVC tubing: thermoplastic elastomers can be an opportunity, not only an alternative. TPEs, however, have not been easy to bond to other

With rapidly advancing technologies and increasing regulatory requirements, today’s customers are asking for more material knowledge and consistent processes in order to minimise variation and improve performance.

Brilliant Mind Domenico Uccheddu from Francesco Franceschetti Elastomeri looks at the TPE extrusion world and tubing for medical use

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COVER STORY

Property

MARFRAN. MED M

MARFRAN. MED SM1

MARFRAN. MED HTR

MARFRAN. MED HTRE

Hardness range (Shore A/D)

30A – 90A

50A – 62D

50A – 58D

Very good

Transparency

Translucent

Transparent

Good

N/A

Pass

Solvent bondability (cyclohexanone)

Good

USP Class VI biocompatibility testing

Test planned for 2018

Pass

ISO 10993-4 haemolisys test

Pass

ISO 10993-4 haemolisys test

Test planned for 2018

Pass

ISO 10993-5 cytoxicity test

Pass

ISO 10993-5 cytoxicity test

Test planned for 2018

Pass

Plasticiser-free

Yes

Plasticiser-free

Yes

Sterilisation

EtO, gamma

Sterilisation

EtO, steam, gamma

EtO, gamma

Property

MARFRAN.MED GLE

MARFRAN.MED GL

Production process

Extrusion

Injection

Hardness range

From 65 Shore A to 85 Shore A

From 40 Shore A to 42 Shore D

Transparency

Good

Anti-kinking

Table 1: Main features of the new Marfran.Med solvent-bondable grades

Table 2: Key Marfran.Med families for extrusion

such as the substrates polycarbonate (PC) or ABS connectors that are used in standard intravenous tubing sets.

as pipes for peristaltic pumps, urinary catheters, surgery catheters and respiratory-aid devices.

Good bonding characteristics can now be achieved through the use of two new innovative compounds, both Marfran. Med GL and Marfran.Med GLE. These products are transparent, bondable with cyclohexanone and THF medical compounds for both injection moulding (GL series) and extrusion (GLE series), and were presented at Fakuma fair 2017.

Furthermore, Marfran.Med grades can be modified in order to be antimicrobial, preventing microbes from growing on the surfaces of final products.

Unlike adhesives, processing with solvents leaves no chemical residue, as the solvents used evaporate completely to create a clean bond.

ABOVE | RISING STAR: Medical applications are a high-growth TPE sector with applications in tubing, catheters, intravenous systems, resealable membranes and ﬁlms TOP | MINT CONDITION: The transformation processes for Marfran.Med are carried out in a newly dedicated cleanroom, which is compliant with ISO 13485

With the new Marfran.MedGL and Marfran.Med GLE, FFE can offer the market a complete TPE solution for manufacturing infusion sets – from the extrusion of transparent and anti-kinking tubes which can be glued easily with cyclohexanone, THF, or other solvents to the drip chamber produced with our injection moulding grades. In addition to the new solventbondable grades, FFE’s TPE portfolio also includes many medical extrusion grades suitable for a range of applications such

To recommend the best product solution, however, FFE must first clarify the parameters and requirements of processing – eg to ensure that heat will not damage the antimicrobial substance chosen. Marfran.Med Au is a patented compound that contains usnic acid, a naturally antibiotic derivative found in several lichen species. Marfran.Med Au possesses interesting biological properties and is a potent antibiotic, effective against Grampositive bacteria such as Staphylococcus, Streptococcus and Pneumococcus. It also works against other types of bacteria such as Mycobacterium tuberculosis and some pathogenic fungi. Following Norm ASTM E218007 testing, Marfran.Med Au was proven to be effective in its antimicrobial performance, especially against Gram-positive bacteria (99.90% effective).

<1> “Elastomers compound that contains usnic acid”, No.MI2014A001444 (PVC also covered).

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NEWS ANALYSIS

’entente cordiale A firm favourite in the pharmaceutical packaging and medical device sectors, Pharmapack Europe once again takes place in Paris next year on 7 and 8 February

harmapack Europe is the industry’s go-to place to kick-off the year. The next edition of the twoday exhibition and conference for pharmaceutical packaging and drug delivery takes place on 7 and 8 February 2018, at Paris Expo, Porte de Versailles, France. 411 exhibitors and more than 5,290 attendees are expected across the two days hoping to get an update on the latest trends, developments and regulations impacting the industry. Pharmapack exhibitors cover the pharma packaging, medical devices, packaging materials and packaging machinery and equipment industries. They come from 35 countries around the world to present their innovative products and services. Conference The 2018 conference focus is on subjects receiving close review within the industry: 1. Regulatory changes and impacts 2. Challenges in packaging & devices development: biologics, material, sustainability and quality consistency 3. How will new drug delivery revolutionize life and improve treatment adherence?

Pharmapack Europe is the industry’s go-to place to kick-off the year

Visitors will also have the opportunity to benefit from other features, such as the Innovation Gallery showcasing the latest industry innovations, Pharmapack Start-up Hub gathering the most innovative start-ups, the International Meetings Programme facilitating pre-planned networking or the Innovation Tours hosted by industry experts.

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DID YOU KNOW? Each year, the Pharmapack Awards recognise new products that are set to shape the future of the industry in two categories: Exhibitor Innovations and Health Products. The awards are judged by a panel of independent industry experts and are a yearly returning highlight at Pharmapack Europe. 86% of visitors attended Pharmapack 2017 for the quality of the companies exhibiting. Important companies exhibiting include Aptar Pharma, Biocorp and Cetis.

SECTOR HIGHLIGHTS

Headline acts The medical plastics and medtech line up has been impressive this year with no end of innovation and breakthrough. Picking some of the key moments was hard but as always, a pleasure, says Lu Rahman

HOT OFF THE PRESS We kicked off 2017 with some news of our own – that Medical Plastics News readers could now take advantage of two new magazines (MPN North America and Med-Tech Innovation) and an event for the medical device sector (Med-Tech Innovation Expo). Medical Plastics News North America has been running for almost a year and the response to the magazine has been incredibly positive.

Gray said: “It’s exciting to be taking the helm of Med-Tech Innovation magazine, especially at such an important time for the industry. It’s no secret that the NHS faces a massive challenge to reduce admissions and treat patients more efficiently. Now more than ever, the medtech sector has a crucial role to play in achieving these goals.”

The Med-Tech Innovation Expo which will take place at the Ricoh Arena, Coventry, on 25 and 26 April 2018, sits alongside the magazine, offering the sector the opportunity to meet and do business with the UK and Ireland’s leading medtech companies and innovators – an industry currently worth an estimated £27bn.

Just like the European edition, this sister title features the latest trends and advances in the medical plastics sector and presents the market’s news, thoughts and innovative practices to keep readers at This is the UK’s only medical device the forefront of an industry that’s crucial to design, research, engineering and manufacturing event. Med-Tech advancing healthcare internationally. Innovation Expo 2018 will bring together all stakeholders involved in the medical The current MPN has always maintained device innovation process, the exhibition a strong connection with its US audience showcases companies from the and the team noticed that over recent medical device supply chain alongside years, this section of readership has grown a conference that delivers insight, making the time right to offer a dedicated publication for this forward-looking region. intelligence and education through a programme of expert speakers. Just like the original mag, the new US“It’s exciting focussed title provides a multi-platform to be taking hub for anyone working or targeting this the helm sector. It’s a place to discuss, promote and of Med-Tech learn – just like its European counterpart. Innovation And with the same quality of readers – magazine” says senior decision-makers from some of the David Gray world’s most inﬂuential medical devices OEMS, it provides increased opportunities for both readers and advertise to reach and communicate with the wider medical device market. Bringing the Med-Tech Innovation brand, which was acquired by Rapid News Communications at the end of last year, into the MPN family has also proved successful. Headed up by MPN deputy group editor, David Gray, the magazine showcases the best new technology and innovation in the medtech sector.

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Press print: Sol with his fully functioning 3D printed hydraulic prosthetic arm which enables him to move his thumb on his own

PUSHING THE BOUNDARIES There’s nothing better than a feel-good story which is why the piece on Stratasys printing technology being used to create a fully-functioning 3D printed hydraulic prosthetic for son of the founder of Ambionics, was a huge hit in the MPN office. Ben Ryan developed a prosthetic for FUTURE PROOFING infants to wear, enabling a more natural acceptance of prosthetic arms for young With good reason, Industry 4.0 seemed to children. The customised design and be everywhere and there was definitely no production of the 3D printed hydraulic shortage of comment on the future of the prosthetic has delivered cost savings of up smart factory and its goals. to 76%, as well as time savings in design and production of 90%, compared with Industry 4.0 will see industry and traditional methods of manufacture. This manufacturing moving towards increased crucially permits prosthetics to be used at digitisation, automation and integrated an earlier developmental stage. control systems, creating smart factories. It looks set to transform the manufacturing Ryan’s son Sol was born with complications sector via use of the Internet of Things (IoT) which resulted in the amputation of his and artificial intelligence (AI). lower left arm. Ryan designed and created his 3D printed hydraulic prosthetic arm Chris Evans, Mitsubishi Electric, on the Stratasys Connex 3D printer. First recognised how the industry is on its way practicing with prototypes of his design, he to digitisation. He said: “When we start to 3D-printed ﬂexible actuators and a powerconsider Industry 4.0 it can be confusing. splitting unit for the prosthetic. He says On one level we are looking at the that the DAHB unit enables the wearer to convergence of business systems with the open and close the thumb in manual mode physical plant control but is this new? The or with assistive power (using compressed real impetus behind Industry 4.0 comes air or a hydraulic pump and reservoir), but not just from the link between the plant the grip continues to operate manually in and the enterprise but once we have this the event of power interruption. link, not only can we have the means to “We were fortunate enough to have access to this technology, which enabled us to 3D-print a prototype arm so quickly and cost-effectively. In founding Ambionics, it’s now my goal to ensure that other limb deficient children like my son are not faced with the current constraints and delays of traditional prosthetic manufacture.”

improve performance but also to measure performance against an ideal model – the cyber physical system, if you will.”

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SECTOR HIGHLIGHTS

MATERIAL WORLD Medical plastics is all about materials and we have a continuous stream of expertise detailing the latest trends and innovation in this field. One of my favourite breakthroughs came from scientists at the Swedish Medical Nanoscience Center at Karolinska Institutet who found that conducting plastics found in smartphone screens can be used to trick the metabolism of pathogenic bacteria. By adding or removing electrons from the Perfect plastic surface, bacteria may be tricked package: into growing more or less. The method To identify the ideal may find widespread use in preventing material for bacterial infections in hospitals or improve its packaging, effectiveness in wastewater management. Eastman looked to extruder Pacur

“When the bacteria land on a surface full of electrons, they cannot replicate”, explained principal investigator Agneta Richter-Dahlfors, professor at Karolinska Institutet’s Department of Neuroscience It was good to read Aneta Clark, Eastman and director of the Swedish Medical Chemical Company outline how to Nanoscience Center. “They have nowhere address industry needs for medical device to deposit their own electrons which they packaging with advanced materials. need to do in order to respire.” She explained how medical professionals On the other hand, if the bacteria are admired for their ability to perform in encountered an empty PEDOT surface, the high-stress environments — balancing a opposite happened, as they grew to a thick patient’s urgent needs with maintaining biofilm. detailed processes that prevent future issues. They are surrounded by tools that “With the electrons being continually should help them in these situations but sucked out of the surface, bacteria could she asked us to consider what happens continually deposit their own electrons, to their process when tools shift from giving them the energy they needed to being helpful to being a burden. Often it grow quickly”, said professor Richterisn’t even the tools’ fault. Rather, it’s the Dahlfors. packaging that stymies quick responses. At the ﬂick of a switch, the research team found it could either abolish bacterial growth or let it continue. This has many implications for both health and industry.

Packaging, said Clark, can become the medical professionals’ worst enemy when difficult — at worst, hindering their ability to save lives. On the other hand, when done correctly, packaging helps medical professionals be the hero, executing very complex processes quickly.

“To begin with, we can coat medical devices with this material to make them more resistant to colonisation by bacteria”, said professor Richter-Dahlfors. According to Clark, some of the newest medical device packaging developed by Plastic Ingenuity, one of the largest custom thermoformers in North America, did just this. Made with a new material that offers more design ﬂexibility than alternative offerings, this packaging met customer needs that also kept devices sterile and safe.

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Bringing Healthcare Solutions to Market Visit us at Pharmapack — February 7 & 8, 2018 in Paris, France.

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For additional information about Trinseo in the Medical Devices market contact:

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SECTOR HIGHLIGHTS

Top picks

BABY LOVE: 3D PRINTING AIDS NEONATAL TRAINING

Many of my favourite stories come from the work being carried out at universities. There’s some real groundbreaking work coming out of these institutions which will of course filter down into the medtech sector improving health outcomes across the globe.

There are two key components SUPERIORITY COMPLEX: to the mannequin: The ribcage/ MAKING STRONGER, spine, which acts as the housing CHEAPER IMPLANTS for the second component, the internal organs. The sheer A really great story was the one complexity of human anatomy is that came out of the University of very hard to recreate realistically Florida (UF) which claimed that with any other production an advance in 3D printing should method as well as increased cost lead to significantly quicker and lead times. implantation of devices that are stronger, less expensive, more ﬂexible and more comfortable than anything currently available.

Researchers lay out the process they developed for using 3D printing and soft silicone to manufacture items that millions of patients use: Ports for draining bodily ﬂuid; implantable bands; balloons; soft catheters; slings and meshes.

Earlier this year Ben Redwood, 3D Hubs, explained how Eindhoven’s University of Technology had developed a new neonatal training technique with help from 3D Hubs. The university is home to PhD student, Mark Thielen, who is aiming to increase surgical and procedural success for neonatal patients. Using 3D printing and 3D Hubs, Thielen developed an optimised training experience using lifelike newborn models with functional organs capable of intelligent sensor feedback.

HEART ON YOUR SLEEVE: SOFT ROBOTICS HELPS HEART TO BEAT

For surgeons and nurses, A soft robotic sleeve developed interacting with anatomical by Dr Ellen Roche of National models is important to the University of Ireland Galway success of surgeries and medical has been designed to help a procedures. Within the neonatal heart to beat. The sleeve wraps field, it’s incredibly difficult to around the organ, twisting and practice correctly with the current compressing in synch with state of practice mannequins the beating heart, potentially which lack the complexity opening new treatment options and feel of a newborn patient. for people suffering from heart Thielen’s research is to develop failure. mannequins which have all their major internal organs functioning Ventricular assist devices (VADs) and equipped with sensors to are already used to sustain endmonitor key measurements such stage heart failure patients awaitas pressure, stress and impact ing transplant. They extend lives during trial procedures (eg CPR, albeit at a high risk due to the intubation). number of complications that can occur resulting from their design. To do this he uses 3D printing This includes clotting requiring due to the range of material patients to take blood thinner available for testing and, most medications. The soft robotic importantly, the organic shapes sleeve does not directly contact the technology is able to create. blood, avoiding that risk. With heart failure affecting 41 million people worldwide, the hope is the device may one day be able to bridge a patient to transplant or to aid in cardiac rehabilitation and recovery.

Currently, such devices are moulded, which can take days or weeks to create customised parts designed to fit an individual patient. The 3D printing method cuts that time to hours, potentially saving lives. What’s more, extremely small and complex devices, such as drainage tubes containing pressure-sensitive valves, simply cannot be moulded in one step.

With the UF team’s new method, however, they can be printed.

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Let’s get to work on your project Phone: +353.61.331906 E-mail: oeminfo@teleflex.com Web: www.teleflexmedicaloem.com ©2017 Teleflex Incorporated. All rights reserved. Teleflex and “Work With The Experts” are trademarks or registered trademarks of Teleflex Incorporated in the U.S. and/or other countries.

COLLABORATION

edical device manufacturers are continually challenged to be innovative while operating in a highly regulated environment. When regulations or market conditions demand a change or create a new opportunity to improve patient safety, a manufacturer often needs to step outside its own comfort zone. Starting early in a new product development process can reduce risk, eliminate false starts and avoid costly delays in bringing effective products to market.

MAKING THE CONNECTION

Technology collaboration is vital! Two companies explain how collaborating early in the development process is expanding opportunities for technical innovation and commercial success.

Eastman is far more than a raw material supplier. It is also a partner in the entire development process. The company explains how its technology collaborations Two collaborators with a plan begin and succeed Insight and long-term vision

have fuelled the successes of Elcam Medical and Eastman Chemical Company. Through years of experience working with hospital and government regulations, both are better prepared to anticipate future needs—then plan ahead for success. Elcam Medical is manufacturer of disposable medical devices for the OEM market. Its validation and verification process helps it collaborate effectively with OEM customers. Eastman Chemical is a key player in medical grade polymer solutions. For more than 65 years the company has worked with customers to deliver innovative products and solutions while maintaining a commitment to safety, confidentiality and sustainability. Its ‘total solutions’ approach to the medical industry now offers world-class technology platforms and even greater insights into technical support in design, processing and secondary operations. Working together the companies discovered many shared values that work in harmony with their specific technical capabilities. Their ongoing collaborations have resulted in chemical- and lipid-resistant connectors designed to meet ISO 80369 standards—both made with Eastman Tritan copolyester. Opportunities to collaborate Elcam understands how to design robust and reliable medical devices. Eastman has specialised and proprietary expertise about its materials. Together, they’ve been able to innovate and bring safe products to market more quickly. “Our two companies have been successful at combining medical science and material science,” according to Eldad Ohayon, marketing director from Elcam: “Based on our individual expertise and shared trust, we engage early in the development process to save time later in the process.”

SOLUTIONS PROVIDER: Eastman Chemical is a key player in medical grade polymer solutions. Image shows how the company’s expertise is used to manufacture connectors

CONCEPT Early in the concept phase, Elcam considers regulatory issues and fitness for use (FFU) of candidate materials. How will the product be used? What stresses will be applied? What chemicals will it contact? Are there minimum rigidity or toughness requirements? Answers to these questions help inform material selection and avoid costly false starts. MATERIAL SELECTION Meanwhile, Eastman refines data regarding its polymers, such as biocompatibility or compliance with other regulations. Eastman shares data with Elcam and can provide Product Regulatory Information Sheets and other documents required for premarket 510(k) submissions. Knowledge of material properties also can make processing more efficient— and can help provide consistent quality and reproducibility. DESIGN Elcam has a solid history of innovative designs. Eastman provides expertise as well as specialised technology— including mould ﬂow and mechanical simulations. At this critical design stage, it is common for Elcam to also talk to other stakeholders— including mould designers and toolmakers—as part of its validation and verification process.

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TRIALING Trial support validates the material and design choices and helps make any needed adjustments. Eastman uses infrared cameras as a specialised technology to monitor the mould performance and the cooling of the mould and parts. Also the drying capabilities are checked during the trial phase; the dew point was monitored under Statical Process Control (SPC) methodology. MANUFACTURING Early collaboration often eliminates any manufacturing issues before the first piece is produced. Unfortunately, many companies wait for the trialing and manufacturing stages to identify problems. Then, they are under a time and budget crunch to troubleshoot and find someone to fix the problem. TESTING Eastman continually tests properties of Tritan and other medical-grade polymers using equipment that gives Elcam specialised analyses they may not find on their own. Throughout this technology collaboration, the companies apply this information to confirm the material’s fit for the specific applications. For example: • They test how a part will withstand gamma radiation sterilisation. • They reproduce exposure to different chemicals and stresses that can reduce functionality. • They expedite accelerated aging and other tests required for regulatory compliance and retention of product performance. 25

PLEASE VISIT: HALL 8B/ L31

DIGITAL HEALTH

www.nolato.com

Doctor doctor: How your GP could have an increasing influence on medical device manufacture Lu Rahman looks at how the digital health sector is increasingly influenced by healthcare professionals and consumers and the opportunities this brings for medical device manufacturers

earing about disruptive technologies is a bit old hat now. But before we all start rolling our eyes, recalling the number of times we heard this about the digital health sector, it’s worth acknowledging that actually this was and still is, about as disruptive as you can get. Yes we know that the increase in connected technology has and is altering the way we access healthcare. In a few years the growth in online GPs and pharmacies has proliferated; we’ve seen talk of the paperless NHS move evercloser to becoming a reality; apps to help with a range of illnesses and conditions have become validated by the healthcare sector and there is an increasing number of hospitals incorporating digital technology into their processes and procedures on a weekly basis – digital transformation is rife. This is all fine and good you might think if you work in the NHS or if you’re looking for online health services. But the medical device sector, and those that supply it, has also seen a marked transformation

away from manufacturers to other health care stakeholders.” It’s fascinating stuff and offers real potential for medical device manufacturers to become involved in collaborative work with these stakeholders to create and nuture technology in a way we don’t often see. It’s exciting to think that a device can be manufactured with firstclass expertise behind it, from the user and the manufacturer. What better way to create products that work and really are fit for purpose.

too. Connected devices are being used on a global scale and whether it’s for personal health tracking, administering drugs such as biologics in the home setting, or monitoring conditions such as diabetes, the digital health sector is burgeoning. In September 2015, Monitor Deloitte produced an industry study for the Office of Life Sciences – Digital Health in the UK. It found:

grow at 35% in the UK and 49% globally from 2014-8. The sector shows strong and positive opportunities. But there’s one area in particular that I find interesting and that’s how we seem to be seeing a movement and drive for innovation shifting from manufacturers to healthcare professionals and consumers. Demand is driving the innovation from the ground, the grass roots if you like. EY recently picked up on this too.

 The global market for digital

health was worth £23bn in 2014 and is expected to almost double to £43bn by 2018  The UK market size for digital health is £2bn and is expected to grow to £2.9bn by 2018, predominately driven by mHealth apps  Digital health systems represent the largest market both globally and in the UK, where they contribute 66% of digital health sales  The most promising market for growth is mHealth apps, which although is currently the smallest digital health market sub-sector, is predicted to

Its Pulse of the Industry 2017 report has highlighted some key medtech findings: “In 2017, the industry demonstrates resilience and agility even as the pace of change accelerates on technological, reimbursement and regulatory fronts and new digitally based operating models shift power to consumers”. In the document, Klaus Schwab, founder and executive chairman of the World Economic Forum, describes how a “blurring [of] the lines between the physical, digital and biological spheres” is altering “business models, as decision-making power shifts

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I’ve been interested in the concept of the ‘doctorpreneur’ for some time now – medics turned inventors. The blurring of boundaries between science, technology and manufacturing is fascinating and holds real promise for a future where the entire medtech chain works in collaboration pushing the boundaries of healthcare, creating products with real expertise at their core. I can’t think of many industries that work in this way, where users and stakeholders help shape the sector. It offers great potential for manufacturers as well, of course. The potential to design and make products that do what they should do, that offer results in terms of engineering, compliance and mass market appeal, is in my view, currently unrivalled. The digital health sector offers immense challenge yet significant opportunity for global device manufacturing. As the supply chain makes demands upon markets such as sensors, adhesives and micromanufacturing, it also offers significant growth potential for the companies that look to work in tandem with healthcare professionals to design devices for the future. 27

USP Class VI Approved Silicone One Part Adhesive MasterSil 910Med

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Lubrizol LifeSciences is your medical device solution partner. We provide support from idea to execution. How we do it: • Polymers: comprehensive, customizable, application-specific medical grade materials • Formulation: advanced drug delivery solutions, including drug-eluting devices • Manufacturing: contract manufacturing for medical device and components To learn more, visit www.lubrizol.com/lifesciences

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MED COMPA T O BO H: 8A / L31 7/26/17 11:13 AM

DIGITAL HEALTH

Success

in the making Phillips-Medisize examines the critical considerations device manufacturers should bear in mind when producing high viscosity / high volume drug delivery devices

As drug manufacturers consider various drug formulation options, early engagement with device designers and device manufacturers is critical to developing the most eﬃcient overall strategy for the drug/ device life cycle

smaller-gauge needles that patients prefer. Since biologics cannot be taken orally they must be delivered via an injection.

Many biologics are highly concentrated, so a prescribed dose may be very viscous or require large volumes of the medication to be injected slowly over time. This can make it difficult to deliver a consistent dose, potentially impacting patient adherence to a given therapy.

While the challenges of HV/HV are not unique to biologics, these drugs demand special attention from device developers. From a drug delivery device perspective, higher viscosity drugs require more force to push ﬂuid through the narrow orifices used in delivery (eg. a cannula). This force, or syringeability, is dependent upon factors including desired ﬂow rate, needle length, and needle diameter, as well as viscosity. Any small change in the needle diameter will result in a large change in the plunger force. In order to be truly versatile, the device also needs to be able to deal with the following aspects:

s the use of biologics continues to increase, early involvement between the drug manufacturers, device designers and device manufacturers is critical to the development of the most efficient overall strategy of drug/device life cycle.

There has been a rise in popularity of wearable self-injection systems for biologics. Instead of scheduling a doctor’s appointment for certain treatments, a wearable device allows patients to selfadminister injectable medication. By 2020, biologics are expected to make up more than half of the world’s top 100 selling drugs. To keep pace with these trends, device designers are tasked with overcoming various challenges associated with delivering these drugs. In particular are issues of high viscosity and/ or high volume (HV/HV) associated with biologics. For proteins, issues of viscosity, solubility, and protein aggregation become major obstacles, especially with the

Design considerations It would seem simple to increase the needle diameter to accommodate a more viscous drug as a larger diameter needle would lead to reduced plunger force. However, a larger needle would also increase pain at the site of injection. Maintaining a smaller needle will lead to higher forces and higher than ‘normal’ plunger force will lead to user fatigue and poor user experience. One solution is the use of an assisted delivery device, such as auto-injectors used for epinephrine delivery. These can WWW.MEDICALPLASTICSNEWS.COM

be fitted with power sources that drive the plunger at forces higher than could be provided comfortably by the user. This approach enables device designers to maintain a smaller gauge needle and place the burden on the power source to provide the high force needed for delivery. But this approach is not without issues. These include: Size A power source capable of providing the force required to push large molecules through a small needle often needs to be large. However, the market trend suggests users prefer smaller devices. Material New high-strength materials can be used to help alleviate the issue of size by deploying smaller wall sections and structural features in devices and container closures – miniaturising them. New material technologies can also be used to derive power sources (e.g. springs) that are smaller and yet provide the same forces. Safety Stored energy devices, such as springs under compression, require robust safety features to prevent injury, device failures, and accidental actuation. Where devices are delivering viscous drugs, this is important. An accidental drop, material 29

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DIGITAL HEALTH

fatigue, failure of the glass container closure or excessive vibrations can lead to catastrophes that could injure users or prevent lifesaving drugs from being administered. The aforementioned approach focuses on maintaining a smaller needle diameter by accepting a higher plunger force. This approach centres on different ways of executing a high force power source. Another approach could be reducing plunger force (while maintaining a smaller needle) by simply lowering any of the variables in the numerator of the HagenPoiseuille equation (Figure 1). Figure 1 128QμLA F= πD4 F=plunger force Q=ﬂow rate μ=viscosity L=needle length A=plunger area D=needle ID

One change could be reducing the diameter of the plunger and reduce the plunger area. However, this has size implications, as the syringe or device would need to become longer to accommodate the same drug volume. Another option would be to reduce the ﬂow rate, lowering the force but increasing delivery time. Likewise, decreasing viscosity can be achieved through dilution but the increased volume also increases delivery time. Therefore, these solutions require a different delivery approach that cannot be achieved through direct injection methods. One approach is the use of IV delivery where patients receive an IV solution with the drug mixed into the bag or bottle. This reduces the viscosity of the delivered solution while reducing the ﬂow rate. However, this method prolongs the delivery time. Some drugs have specified delivery through an IV bag or bottle over a certain period of time. While patients may accept this form of delivery for otherwise unavailable therapies, quicker and more convenient delivery methods are always preferred. In response to these limitations, body worn infusion pump devices may be implemented.

These are common in diabetes treatment, in which users wear an insulin pump connected to their body via a cannula. However, for delivering high volume drugs, the device needs to be treated as a prolonged injection device rather than a continual-use pump. As such, these devices carry a different set of challenges: Size The size challenge in body worn devices lies in the necessity to slow down the delivery speed. While the delivered force required to push the drug through a needle may be smaller, it needs to take place over a period of several minutes to a few hours. Any additional components, that can modulate the delivery of power over a long period of time, will require more space and cause the device size to grow. User interface Unlike direct injection devices, where the user maintains constant interaction during its use, users of body worn devices cannot be expected to maintain the same level of interaction over a course of several minutes or hours. The ability of the device to provide error alerts, indicate progress, and confirm delivery, becomes critical. Body ﬁxation method The first challenge with body-worn devices is where they should be placed on the body. Depending on the location, different fixation methods should be considered: • Is the tissue more sensitive? • Can an adhesive be used on this part of the body? •Is the adhesive aggressive enough to hold the device in place over the required time period? • Will it cause allergic reactions? • Perhaps a band of some sort should be used instead of an adhesive? • Will the device need to survive wet conditions or withstand physical activity? • How will the patient feel about wearing a device? • Will the skin surface need to be shaved before application? • Does the patient feel ‘tethered’ to their device? Another consideration is departing completely from the conventional needle based designs, and looking at alternate injection platforms. Microneedles and needle-less technologies are potential alternatives that could be explored for delivering high viscosity and/or high volume drugs.

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Human factors considerations As evidenced by the FDA’s increased attention to human factors considerations in medical devices, a thorough investigation of a user’s interaction is as important as the performance of the device. A well-performing device, that is difficult to use, can detract from patient compliance. Device developers will often conduct design and manufacturing process failure mode and effects analyses (FMEAs). Discovering a significant potential use error, once the development or manufacturing phase has begun, can be costly. Device trend considerations Connected devices are becoming more prevalent, particularly medical devices. Their benefits include monitoring patient compliance, tracking user activity/location to customise patient care, and managing refills. But these benefits need to be weighed against the implications of their deployment. • What are the regulatory implications? • Will connection technologies such as Bluetooth, NFC, etc. require FDA oversight? • Can third party apps be permitted? How will updates to apps (eg bug fixes) be managed? • Since the predominant method of app distribution is only through a few entities, how will the distribution of apps be managed for medical devices? • How will the manager/holder of user data be regulated? • What are the infrastructure implications? • Who will manage user data? • Will user data need to be anonymised? • Which connectivity technologies should be used? • How should device recycling/disposal be managed? If the device has a needle, can an electronic device be disposed of through a conventional sharps disposal? • How can the device/system be protected from hacking? Overall device development strategy Manufacturers of devices understand the necessity of ‘early engagement’ with device designers and developers. This stems from the simple fact that it is easier, cheaper, and quicker to make changes to a design at the beginning of the development cycle rather than towards the end, causing delays to the process. For the drug developer and device designer, early considerations regarding device strategy can avoid crippling challenges down the road. Of course, the most critical and central consideration for device designers should be the well-being of the patient.

Medical device manufacturers are challenged to design, develop, and manufacture products which enable the production of innovative therapeutic solutions. In order to ensure the production of these therapeutic solutions, there are many important aspects that must be considered to help facilitate improved patient outcomes. These considerations include device design, material selection, processing, sterilisation, biological response, and end use environment. For this article, we will focus on material selection, namely bioresorbable polymers which are biocompatible materials that offer medical device companies ďŹ&#x201A;exibility in design and processing methods. What are bioresorbable polymers? Bioresorbable polymers are materials that are absorbed in the body after performing the desired therapeutic function. Implants produced with bioresorbable polymers are decomposed in the body by natural degradation pathways into water and carbon dioxide. There are two kinds of bioresorbable materials, biopolymers which are naturally derived and biopolyesters which are synthetically produced. Biopolyesters include for example polylactide (PLA) poly lactide-co-D, L lactide (PLDL,) poly lactide-co-glycolide (PLGA,) poly lactide-co-caprolactone (PLCL,) poly caprolactone (PCL) poly dioxanone (PDO,) and poly lactide-co-trimethylene carbonate (PL-TMC). These biopolyesters are available as either amorphous or semicrystalline polymers which provide a range in mechanical strength and degradation profile. Bioresorbable polymers provide the possibility to customise the level of crystallinity, hydrophilicity, molecular weight, and degradation profile of the polymers to further improve mechanical properties and biocompatibility. Typical applications Bioresorbable polymers have been successfully used in low load bearing applications due to their mechanical properties and degradation profiles. Some of the typical applications include sutures, rods, plates, screws, and scaffolds for tissue engineering. The possibility to fine tune these polymers based on targeted part performance requirements provide medical device manufacturers ďŹ&#x201A;exibility in design for optimal functionality in their device. Cranio-maxillo-facial (CMF) Poly L-lactide-co-D, L lactide (PDLLA) have good tensile strength, excellent mechanical and thermal properties and are used in various orthopaedic applications including cranio-maxillo-facial devices which are used to treat deformities in the head. Since most of these applications do not require 32

Going going g the implant to be placed under an elevated mechanical load, bioresorbable materials used for these treatments have focused on enhancing the biological response and ability to promote healthy bone regeneration without causing any adverse side effects upon degradation. One of the design benefits of such implants made with bioresorbable materials is the possibility to shape the CMF plate to the desired geometry in the operating room using heat to ensure an ideal fit with the patientâ&#x20AC;&#x2122;s anatomy. Sutures and suture anchors Poly dioxanone (PDO) provides medical device manufacturers with a polymer that allows them to manufacture a device requiring flexibility, good mechanical properties, and fast to moderate degradation profile of 6 to 12 months. This material is ideal for sutures because it is able to hold regenerating tissue systems in WWW.MEDICALPLASTICSNEWS.COM

place long enough to allow for full healing at which point the suture would degrade and be resorbed by the body. Polylactides (PLA,) poly L-lactide-co-D, L lactide (PDLLA,) and poly lactide-co-glycolide (PLGA) materials are options for producing suture anchors due to their mechanical properties and moderate degradation profile. Some medical device manufacturers also offer suture anchors made from a composite blend of bioresorbable polymers with calcium phosphate to enhance bone growth. Such implants help provide quality patient outcomes and improved patient satisfaction. Interference screw Interference screws are used in reconstructive surgery of the anterior cruciate ligament (ACL) within the knee. For this particular application, the mechanical properties of bioresorbable materials as well as the ability to prolong

BIOABSORBABLE POLYMERS

Bioresorbable materials are used in implant applications as they help facilitate the healing process and eventually absorb within the body

Sabine Fleming, Evonik Health Care, details how medical device companies can use bioresorbable materials to develop devices which improve patient outcomes

g gone Interference screws are used in reconstructive surgery. The mechanical properties of bioresorbable materials makes them a strong choice for these products

the degradation time makes polylactide (PLA) poly(lactide-co-glycolide) (PLGA,) and poly(L-lactide-co-D, L lactide) (PDLLA) particularly advantageous material options. As with suture anchors the addition of calcium phosphate helps promote bone growth, while absorbing at a slow enough rate to allow proper functionality of the implant. This controlled degradation is highly beneficial for this application as the ingrowth of bone tissue into the interference screw region allows for the native tissue fixation of the implanted tendon to occur resulting in better patient outcomes once the bioresorbable screw is completely degraded. ScaďŹ&#x20AC;olds for tissue engineering Scaffolds are devices which are used for tissue engineering applications such as bone, cartilage, ligament, skin, and vascular tissues. These products are three dimensional structures, typically porous and hydrophilic, which must be biocompatible and should resorb at the same rate as the repair site remodels. Bioresorbable composites highlighted in the above applications are examples of materials which help to provide tissue engineering products for orthopaedic applications. Such polymeric structures help promote the regeneration of bone and cartilage while addressing the mechanical need of the targeted repair site. Polycaprolactone is another polymer which is used to manufacture scaffolding for tissue engineering and is different from lactides and glycolides in itsâ&#x20AC;&#x2122; high elongation and high permeability. All of these bioresorbable polymers are ideal implant materials in terms of biocompatibility and tailorable degradation parameters.

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Versatility in processing methods Bioresorbable materials may be processed via traditional manufacturing methods including injection moulding, extrusion, compression moulding and machining. These polymers may also be used in novel manufacturing methods such as electrospinning, selective laser sintering, and fusion deposition modelling. This versatility in fabrication processes provides device manufacturers the opportunity to produce intricate devices using the method which best meets their part requirements. However, to achieve the targeted mechanical performance of the final device, manufacturers should consider the suitability of the implant design in addition to the material properties and fabrication processes. The degradation profile of the final device depends on multiple factors such as polymer crystallinity, molecular weight, part design, sterilisation method, and in-vivo environment. These considerations are especially important when designing implantable devices with bioresorbable materials. Bioresorbable polymers in medical devices Bioresorbable materials are used in implant applications because they help facilitate the healing process while temporarily restoring the functionality in targeted areas and eventually absorbing within the body without a trace. Such implantable medical device applications include orthopaedic fixation devices, surgical screws, plates, and coronary stents. Unlike other biomaterials, bioresorbables may minimise the need for follow up surgical procedures. Hence, the breadth of commercially available bioresorbable materials along with the possibility to create unique custom polymers offer medical device companies many options in developing devices which deliver life improving therapies.

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13–16 November 2017 Hall 8A P04

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3D PRINTING

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The soft approach Soft robotics firm, qbrobotics has boosted protoyping efficiencies and been able to offer increased customisation, by using 3D printing

talian automation company, qbrobotics, specialises in the production of soft robotics produced using traditional manufacturing methods. After several years of incurring lengthy lead times, the company turned to Stratasys 3D printing in a bid to accelerate its prototyping process. Since integrating Stratasys 3D printing into its operations, qbrobotics has not only slashed its prototyping costs by a substantial 90% and reduced lead times by 85%, but is also enjoying greater customisation.

“We required a prototyping process that would overcome traditional manufacturing bottlenecks without compromising on the quality,” says Bonomo

robotics is fundamental to our operation and that’s why we required a prototyping process that would overcome traditional manufacturing bottlenecks without compromising on the quality,” says Fabio Bonomo, CEO and electronics designer at qbrobotics. According to Bonomo, 3D printing has completely transformed the company’s prototyping cycle, bringing with it considerable efficiency-savings as a result.

Originally created as a spin-off University of Pisa, qbrobotics is now an established pioneer in next generation soft robotics – a sub-field or robotics, concerned with non-rigid robots constructed with soft and deformable materials like silicone, plastic, fabric, rubber – which by its very nature, demands pliable materials that mimic human motion. As these have a direct role in people’s lives, the company implements the latest technologies throughout its production line. These functional prototypes endure extensive development and functional testing to ensure they pass safety regulations for human use before moving to final manufacturing.

“With the ability to iterate often and realize complex designs, Stratasys 3D printing technology allows us to determine the best design without incurring considerable time and cost penalties. This capability has reduced our prototyping cost by a massive 90% and we are now producing fully-functional prototypes 85% faster than our previous method. Crucially, this has propelled our time-to-market,” he adds.

The company’s portfolio includes two innovative machines: the qbmove – a modular platform for the construction of soft robots, and the qbhand robotic hand. Previously, the company used traditional manufacturing methods throughout its prototyping process although this would typically incur lengthy lead times and expensive prototyping costs. Should iterations be required, these would often be expensive and could delay production further. These manufacturing bottlenecks led qbrobotics to explore the potential prototyping efficiencies achievable with Stratasys FDM 3D printing with the purchase of a Fortus 250 3D printer.

Using Stratasys’ high-endurance ABSplus 3D printing material, the company now produces durable prototypes that perform much like the final personalised robotic. This allows the company to evaluate and test designs against individual customer requirements.

Customised robotics For qbrobotics, 3D printing is unlocking the door to wider business opportunities, most notably in the production of sample customised robotics.

“Our previous methods didn’t deliver the capabilities to produce prototype personalised robotics cost-effectively so this wasn’t a feasible business opportunity for us. However, 3D printing allows us to develop robotics with the best functionality, ergonomics and aesthetics to meet the individual customer’s requirements - without the usual and considerable time and cost issues. This is crucial to maintaining our customers’ quality of life,” says Bonomo.

Greater prototyping eﬃciencies “Maintaining our customer’s welfare with the rapid production of their

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MERGERS & ACQUISITIONS

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Deal or no deal E

arly this year Matt Robida, Spectrum Plastics Group, explained to MPN Europe magazine how the company’s recent merger highlighted how the trend for medical consolidation. Pexco, the Georgia-based specialty extrusion and custom plastics company with a growing position in medical plastics, and Kelpac Medical, the Wisconsin-based medical tubing manufacturer, merged and rebranded as Spectrum Plastics Group. According to Robida, the merger “illustrates how the effects of consolidation at the major company level are impacting the supply chain. The highly fragmented $25 billion US medical contract manufacturing and outsourcing market, of which 40% is spent on plastics and which is estimated to be growing near 10% per year through 2020, is beginning to show the same signs of consolidation that the majors have been witnessing”. He added that private equity firms and investment buyers, which annually are quite active in plastics manufacturing, as well as private or public Industrial strategic buyers, wishing to get in on the medical growth game, have been participating in and exacerbating this supply chain consolidation trend. Deals between high calibre medtech companies within the supply chain continue to create interest within the sector. Elizabeth Cairns, author of the EvaluateMedTech World Preview 2017, Outlook to 2022 summed up M&A movement in recent years: “After a slow year in 2016 as companies that had made large buys the year before paused to digest their purchases, M&A activity is once again on the up. At nearly $50bn, the total value of mergers closed in the first half of 2017 has already eclipsed the total for all of 2016. Despite this the number of deals struck has been falling; mergers are getting bigger, but also scarcer”.

M&A activity in the medtech sector is going strong. Lu Rahman looks at some of the recent deals taking place in the industry Last year major drug delivery player PhillipsMedisize announced the acquisition of Medicom Innovation Partner of Denmark and its subsidiary in Cambridge, UK. Medicom specialises in connected health drug delivery devices and employs a staff of 90 specialists in Denmark and the UK. This means that Phillips-Medisize now employs about 500 engineers throughout its global design and development network to develop injectable and inhalation devices for the global market. Following this Phillips-Medisize itself was the subject of an acquisition when global manufacturer of connectors and interconnectors, Molex, bought the company. Martin Slark, chief executive officer of Molex said: “Phillips-Medisize brings strong capabilities to Molex in the medical solutions market globally. Combining Molex’s expertise in electronics and our broad manufacturing presence with Phillips-Medisize’s talented and experienced team will help us better serve the growing needs of the global market for innovative connected health solutions.” According to Robida, thanks to “continued globalisation and higher demand for medical technology and services, medical OEMs are diversifying their product portfolio, scale-up operations and gaining market share to improve their negotiating power with hospital systems and the demands of a value-based healthcare model.”

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Bolstering a company’s offering to the market is often a key factor in the decisionmaking process. Nolato recently acquired Polish Grizzly Medical, which is involved in the assembly, post-processing and quality assurance of medical device components and systems. The company has been a supplier to and partner of Nolato Medical since the 1990s. Providing a route into or to strengthen a particular market can of course be a key driving force. Nelipak’s purchase of thermoforming company Computer Designs Incorporated – operating under the name Nelipak Healthcare Packaging – means that the business can strengthen its commitment to the North American healthcare market. DePuy Synthes Products, part of Johnson & Johnson Medical Devices Companies recently acquired Innovative Surgical Solutions (Sentio). According to DePuy Synthes the acquisition underscores the business’ strategy of investing in what it describes as “faster growing segments with technologies that are designed to help improve patient outcomes and bring value to our customers”. DePuy Synthes has also splashed out on 3D printing technology from Tissue Regeneration Systems (TRS). TRS’ 3D printing methods will help enable the company to create patient-specific, bioresorbable implants with a mineral coating intended to support bone healing. Depuy Synthes says the acquisition brings exciting new technology with the potential to personalise healthcare solutions in trauma. M&A activity in the medtech sector doesn’t seem to be showing any signs of disappearing. It will be interesting to see how this bears out in 2018 and how this consolidation will affect the medical technology supply chain going forward. 37

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REGENERATIVE MEDICINE

Reach the PEEK John Devine, Invibio Biomaterial Solutions, explains why composite polymer implants are poised for accelerating take-up in trauma fixation load-bearing by allowing the design of a less stiff construct, which may support the healing process.

i g h - p e r f o r m i n g polyetheretherketone (PEEK) polymer has for some time now been adopted by innovative medical device companies as an alternative to metal implants. Applications include arthroscopy, joint reconstruction, trauma, dental, and cranio-maxillofacial procedures. In interbody fusion, PEEK is the material of choice, used in over 70% of devices. PEEK Optima is one of them and the recent development of an enhanced grade with hydroxyapatite (HA) fully integrated into this polymer has become a further material option for applications where early bone on-growth is required. With trauma plates and nails, physicians accustomed to such standard options as titanium or stainless steel might regard polymer-based material and design progress with slight scepticism. However, material R&D hasn’t stood still in bringing PEEK-based trauma implants closer, in their properties, to human bone and benefits which were experienced and proven in spine seem to be transferable to new emerging technologies. What is more, these advances may have the possibility to change the way forward in trauma treatment. In particular, PEEK-Optima UltraReinforced, a carbon fibrereinforced PEEK (CFR-PEEK) has attracted interest. The material can offer the strength of metal in a composite polymer, suitable for trauma plates and nails, while remaining lightweight. With its favourable modulus of elasticity, it seems to provide the potential for enhanced stress absorption and

The results from some early clinical comparative work with metals, which will be released in October, are expected to increase the interest in these materials. Over time the trauma industry has shown a preference towards titanium plating rather than stainless steel plating to reduce the overall stiffness of trauma constructs. Despite this, complication rates remain significant and some of this may be addressed by continuing the trend towards a lower stiffness construct. In fact, the stiffness of the CFR-PEEK the PEEK biomaterial pioneer, can be ‘tailored’ to suit therapeutic requirements.1 And while the reinforced material has a mechanical strength similar to that of metals1, it has a greater material fatigue life.1 In addition, CFR-PEEK has the potential to result in earlier and greater callus formation.2 From hidden costs to a hidden champion Healthcare providers may prefer to continue with traditional metal implants for fracture fixations. However, the economics of orthopaedics prove to have hidden costs. Delayed or non-unions cost healthcare providers more than US$2 billion in failed procedures in the US alone.3 Then there is the additional cost burden of revision surgery along with the negative impact on the patient’s quality of life. The improved fatigue resistance achieved with PEEK-Optima Ultra Reinforced can potentially reduce complications related to implant failure. In cases where implant removal is required, implants made with the carbon fibre composite material eliminate cold welding

problems associated with the use of metal components and minimise bone on-growth4-5 on the implant. This can ease implant removal, reducing operating times by as much as 2.3 times and associated revision surgery costs by as much as 50% compared with metal plates. 6-7 This is in a situation where non-union rates have been detailed, in the literature, as being as high as 19% for distal femoral plating.8 Demographic challenges: Rising levels of co-morbidities Meanwhile, the worldwide patient population has become more challenging with increasing comorbidities, such as obesity, diabetes and osteoporosis. Complications related to nonunions, delayed unions and implant failure are especially challenging when patients present with such co-morbidities.9-11 For healthcare providers, this is a far from trivial issue. The current figure for obesity is 37.5% of the world’s population, while for diabetes the percentage is now 9.5% of the global population. The figure for osteoporosis stands at 26.5%. These factors, combined with a longer life expectancy and a desire to maintain an acceptable quality of life, have driven the need for alternative biomaterials for use in trauma treatment and fracture fixations. As David Hak, an orthopaedic surgeon with Denver Health at the University of Colorado, notes: “There’s a whole host of patients that are slow to heal. The diabetics, the smokers, patients with open fractures, a whole slew of different patient problems that can lead to delayed bone healing.”

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For PEEK-Optima Ultra-Reinforced, data13 also indicates that implants manufactured with CFR-PEEK can result in 150% greater callus formation13, which may improve secondary bone healing. Results of pre-clinical testing on an ovine model demonstrate earlier and greater callus formation throughout the 12-week study period – particularly within the initial sixweek period including 150% more callus at two weeks.13 Advantages of radiolucency The radiolucency of CFR-PEEK can also be a decisive factor, enabling 360° of fracture visibility in the postoperative monitoring of therapeutic progress. In contrast to metal implants, complications, including breakages, can be detected much more readily when radiolucent CFRPEEK implants are used, allowing a faster and more precise response on the part of the physician. In fact, such implants offer surgeons circumferential visibility of the fracture site during, as well as after, surgery. This assessment of reduction may result in safer procedures since all cortices near a joint are visible, potentially reducing the risk of screw perforation.14 In particular, the radiolucency of CFR-PEEK implants enables the improved capture of MRI and CT diagnostics, with the major advantage that images are artifactfree. Radiolucency also improves the visibility of the surrounding anatomy in polytrauma patients. Improved visibility of the healing process gives physicians increased confidence that they can make an accurate assessment of when to return patients to load-bearing activities.

REGENERATIVE MEDICINE

A CASE IN POINT – Olympic sprinter James Ellington UK Olympic team sprinter James Ellington has been making headlines in the media worldwide. He competed in the 2016 Rio Olympics, but in January 2017 was badly injured in a motorcycle accident. Ellington had sustained multiple trauma injuries, including fractures of the tibia and fibula of the right leg, a broken left ankle, a fractured eye socket, and a broken pelvis. Knowing that the recovery process would be complex James and his physician, James Youngman, University College London Hospitals (UCLH) decided to choose the relatively new treatment option of CFRPEEK implants, because they were aware of the carbon-fibre reinforced polymer’s growing reputation for potentially enabling faster recovery in fracture healing. Surgery included the insertion of a composite nail made with PEEK-Optima Ultra-Reinforced, in the effort to repair the fractures of the right leg. This nail was supplied by CarboFix Orthopedics a company specialising in solutions for the fixation of long bone fractures.

Metal-free distal femur fracture ﬁxation plate made with PEEKOptima Ultra-Reinforced polymer, a carbon ﬁbre composite from Invibio; The trauma plate shown is not available for distribution or implantation © Invibio

composites processing knowledge, capital equipment and manufacturing facilities, contribute to expedite medical-device innovation. For a trauma company that normally offers metal implants, that could represent an investment saving of millions of dollars. Invibio can cut start-up costs, help medical device manufacturers quickly assess how the PEEK-based material will work in their devices and help them develop and commercialise products at a greater speed.

Surgery was performed successfully, and the rehabilitation phase is progressing well. He was able to leave his wheelchair weeks before therapists had anticipated. And in a typical display of passion for his sport, Ellington has even vowed to return to competitive athletics.

The verdict is in – Implantable PEEK polymers are pioneering progress Worldwide, the goal of achieving the best possible clinical outcomes for patients appears consistent. But for a variety of reasons, the medical device industry will have a difficult task of demonstrating that new product Speeding up healing by the use of innovations are addressing this PEEK-polymer implants can be a challenge and, ultimately, improving crucial clinical advantage, potentially patient care. leading to earlier weight bearing, with less muscle loss. For certain applications, orthopaedic surgeons are transitioning from Companies like Invibio partnering stainless steel to less stiff titanium with medical device manufacturers implants. Novel PEEK composites offer and building on its initial research, the potential to carry on this trend to less stiff solutions that potentially result in improved clinical outcomes and as a consequence contribute to reduce the overall cost of care. UKbased Invibio launched an implantable grade of PEEK in 1999 and, after some time, the adoption of the polymer gained speed. Around nine million devices constructed from grades of the company’s PEEK-Optima have been implanted today, potentially improving clinical outcomes – and the polymer continues to be used to actively innovate in the quest for improved patient care. Invibio´s PEEK-Optima polymers are used in 9 million implanted devices worldwide

Given these rather alarming statistics, it is little wonder that the frequency of non-union of the fracture has been assessed as up to 10%.12 And complicating the matter further, metal trauma fixation hardware can fail before union occurs. Plates made with PEEK- Optima Ultra Reinforced, on the other hand, may provide 50 times greater fatigue resistance13, increasing the window of opportunity for union and providing a greater likelihood that healing will occur.

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References 1-18: Supporting information available upon request from Invibio Biomaterial Solutions for all claims.

www.nolato.com

BEST OF BRITISH: With 120 UK companies exhibiting this year, ABHI says it is excited about the diversity of technologies on display

WORLD STAGE: Medica is attended by 132,000 visitors from over 120 countries to ﬁnd out about innovations and trends within the global medical sector

SHOW TIME: The event is taking place from the 13 – 16 November 2017 at Messe Düsseldorf

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MEDICA & COMPAMED

What the world needs now T

he Association of British Healthcare Industries (ABHI) is the official organiser of the UK Pavilion at Medica 2017. As a leading The Association of medical technology trade British Healthcare association, ABHI is well Industries explains positioned to showcase why Medica on 13-16 the best in cutting-edge November, offers a medtech innovation that the global platform for UK has to offer.

With Brexit in mind, the UK government has launched an Industrial Strategy to drive the country forward. As part of this, life sciences has repeatedly been highlighted as a key area for future growth, and medtech identified as a pillar of this strategy.

The event is attended by 132,000 specialist visitors from over 120 countries who use the congress as a meeting place to find out about innovations and trends within the global medical sector. This year, the event is taking place from the 13 – 16 November 2017 at the Messe Düsseldorf, Düsseldorf, Germany.

Benton adds: “To support our government’s ambitions, ABHI recently became the first UK life sciences industry association to create a bespoke membership offering for international companies. The launch of the ABHI International Membership category is a direct action on the government’s call and we at the association are very excited as to the possibilities. Trade will be vital in enabling the government’s vision to become a reality.”

The global congress, a leading trade fair for the medical industry, provides UK companies with the platform to meet with distributors and buyers from around the world; to discuss business with existing contacts and meet with industry peers.

ABHI has, for a long time, offered UK companies a variety of support and opportunities to export globally. International Membership is making these links more accessible for international companies wishing to partner with their British counterparts.

With 120 UK companies exhibiting this year, ABHI says it is excited about the diversity of technologies on display.

The trade association is signposting and introducing international companies to a highly-developed network within the UK health system with a view to supporting the development of joint-ventures and distribution agreements. As well as access to written briefings, webinars and market intelligence reports, membership is underpinned by the collective expertise of ABHI’s senior leadership team and the international division of the association.

UK companies

Paul Benton, managing director of International at ABHI, says: “It is a wonderful expression of what the industry has to offer in providing value-based healthcare solutions for patients across the globe. The UK is open for business and is keen to forge global healthcare links and Medica offers the perfect platform to do this. Leading British businesses are bringing solutions to healthcare challenges that will transform the way care is provided in the future.”

You can visit the UK Pavilion in hall 16G19-5

The UK is experiencing unprecedented change as it navigates its exit from the European Union. Despite this, the medtech sector remains undeterred. It continues to grow at both pace and scale, and is now worth over £17billion to the UK’s economy. The industry remains resolute and is actively seeking opportunities post-Brexit. WWW.MEDICALPLASTICSNEWS.COM

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

Visit Qosina November 13-16, 2017 at Compamed - Stand 8AL16 and Medica - Stand 6J27, Messe Düsseldorf, Düsseldorf, Germany. Qosina stocks thousands of OEM single-use components and offers excellent customer service, free samples, low minimums and immediate delivery. Visit qosina.com to see over 5,000 stock components, place an order or request a catalog.

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COMPAMED

Little and often

Why things are shrinking at Compamed

he trend towards personalised medical care, demographic developments and digitalisation is an important Microtechnology is big driver towards business. Compamed t e c h n o l o g i c a l advances in the has spotted the trend fields of medical for all things smaller technology and which is why it will be healthcare. Health focussing on the sector policies and cost between 13 and 16 pressures are also November in Dusseldorf pushing progress forward. The field of medical technology in particular has given the micro-technology industry a huge boost with its demand for corresponding solutions. Nearly two-thirds of microtechnology companies in Europe supply products, technologies and services to the medical technology and healthcare sectors … they represent the most important sales market for almost 20% of these firms. The share of companies that supply primarily to the market for medical technology will increase by another 5% in the next three years. This is what the IVAM Fachverband für Mikrotechnik (IVAM Association for Microtechnology) has found in its annual survey of economic data from companies and research institutions operating in the field of microtechnology in Europe. Microtechnology will therefore also be playing a major role at the Compamed 201, taking place in Düsseldorf alongside Medica 2017 – the world’s leading medical trade fair – from 13 to 16 November. “Besides digital transformation that has affected all sectors, the miniaturisation of components for creating increasingly handier and lighter product applications also constitutes an overarching technology trend,” says Joachim Schäfer, managing director at the Messe Düsseldorf.

The possibility of tracking blood pressure continuously without the need for cuffs is one of the key innovations at this year’s Compamed. A team of scientists around project manager Dr Hans-Georg Ortlepp at the CiS Research Institute for Microsensors developed the sensor for this application along with the sophisticated method of analysis.

Additive procedures Another topic that has been becoming more and more important at Compamed is additive procedures. The IKTS Fraunhofer Institut has developed ‘bone from the printer’. This has been designed to be used to repair defects in facial areas or bones damaged by tumours that have metastasised.

Active ingredients into instead of under the skin The Hahn-Schickard Association for Applied Research has also dedicated itself to researching, developing and manufacturing technology for microsystems. It has teamed up with a Verapido Medical spin-off in the development and production of equipment, systems and technologies that allow active ingredients to be administered into instead of under the skin. Studies have shown that active ingredients introduced intradermally are available at considerably faster speeds than those administered subcutaneously.

Microstructures from 3D printers Multiphoton Optics is active in 3D printing. This company is producing a high-precision 3D printing platform and software for the additive and subtractive manufacturing of randomly shaped structures that are realised either in the full or on surfaces of materials. The technology supports the high-precision manufacturing of optical 3D interconnects, aspherical or free-form microopitics as well as biomedical products such as scaffolds for tissue engineering, microfluidic cells and drug-delivery structures.

CorTec is going to be exhibiting at the Compamed for the second time. This young company that specialises in medical technology is working on the next generation of active implants. It is developing and producing implanted electrodes for drain-outs and stimulation in the central and peripheral nervous systems.

The world of small and smallest solutions for medical technology therefore remains a subject that will remain important to Compamed in Düsseldorf. Besides microsystems technology, the focus this year will be on nanotechnologies, production technologies and process control. Specialists will also be presenting parallel talks about current developments along the entire process chain of medical technology at the Suppliers Forum. This year, the event will be focusing on digitalisation, wearables, 3D printing and regulations.

Blood pressure without cuﬀs One important application is the field of wearables – mobile, almost entirely concealed and comfortable systems for recording and analysing our vital parameters for medical analysis. Providing information about a person’s health, data includes the pulse and arterial oxygen saturation, heart-rate variability, respiratory rates and data about vascular stiffness and signs of rising or falling blood pressures. Elevated blood pressure is currently one of the most serious risk factors for cardiovascular disease. WWW.MEDICALPLASTICSNEWS.COM

EXHIBITION & CONFERENCE 7-8 FEBRUARY 2018 PARIS EXPO, PORTE DE VERSAILLES

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LAB-ON-A-CHIP

Chip shot

arlier this year Spectator Health ran the headline, This ‘lab on a chip’ knows when you’re ill before you do. Will Despite suggestions that the regulators the FDA isn’t interested in approve it?

lab-on-a-chip technology, advancements in this field are showing increasing potential for the healthcare sector, says Lu Rahman

The piece by Benedict Spence focussed on the fact that scientists from Rutgers University claim that health issues could be identified through the analysis of blood and sweat using a lab-on-a-chip. According to Spence, the device is small enough to fit in a wearable device and is able to detect the biomarkers of various diseases with 95% accuracy – this, says the developers, will increase to 100% in a short space of time. However, Spence believes that FDA regulators won’t allow the device to be sold to the public as putting its approval stamp on ‘consumer health monitoring technology’ throws up problematic issues such as data protection and misdiagnosis. Despite this, the development of lab-on-a-chip devices is advancing. Harvard’s Wyss Institute recently launched the human Organ Chip project to mimic human influenza

COLOUR RUN: Demonstration of concentration gradient in microﬂuidic system using red and blue colour dye solutions. (Purdue University photo)

infection and pathogenesis in vitro, and identify new drug leads that target host response factors. The development of anti-influenza drugs has been limited by the fact that animal models do not accurately reflect the infection mechanisms inﬂuenza viruses engage in humans. The Wyss Institute’s team will use lung small airway and alveolus chip devices lined by living human lung cells that they previously showed to reproduce normal lung physiology as well as diseases that affect these regions, including chronic obstructive pulmonary disease (COPD), asthma and pulmonary edema. The lung chips are microengineered devices the size of a computer memory stick that contain two parallel hollow channels, each less than 1mm wide, separated by a porous membrane. Lung alveolar cells are cultured on the porous membrane in one channel, and lung capillary endothelial cells are grown on the opposite side of the same membrane in the second channel to recreate the characteristic tissue-tissue interface found within these lung regions. With air streaming through the lung epithelial channels and growth medium continuously streaming through the ‘vascular channels’, the team can maintain, study and manipulate the re-engineered organ units over the course of weeks to months. “Virtually all existing anti-viral drugs target the virus itself, however, the ability to study inﬂuenza infection in human lung chips also allows us to study the host response to infection in a highly controlled way,” said Donald Ingber, principal investigator (PI) and Wyss founding director. Meanwhile researchers at Purdue University are creating a device that they hope will help identify risk factors that cause breast cancer. The device, known as risk-on-a-chip, is a small plastic case with several thin

layers and an opening for a piece of paper where researchers can place a portion of tissue. This tiny environment produces risk factors for cancer and mimics what happens in a living organism. “We want to be able to understand how cancer starts so that we can prevent it,” said Sophie Lelièvre, a professor of cancer pharmacology at Purdue. Cancer is a disease of gene expression, and organisation of genes is specific to a particular species and organ, which means it wouldn’t be useful to perform this study on rats or mice. Lelièvre needs a model that will mimic the organ in question. She teamed up with Babak Ziaie, a professor of electrical and computer engineering at Purdue, to create the device. The risk-on-a-chip is based on an earlier cell culture device developed by Lelièvre and Ziaie to study cancer progression. To modify it for prevention, Ziaie plans to add nanosensors that measure two risk factors: oxidative stress and tissue stiffness. Oxidative stress occurs as the result of diet, alcohol consumption, smoking or other stressors, and alters the genome of the breast, aiding cancer development. The risk-on-a-chip will simulate oxidative stress by producing those molecules in a cell culture system that mimics the breast ducts where cancer starts. Tissue stiffness has been found to contribute to onset and progression of breast cancer. The team will measure stiffness within a tunable matrix made of fibres, whose density is relative to stiffness. Breast cancer is particularly difficult to prevent because multiple risk factors work independently or in combination to promote disease onset. To account for this, the risk-on-a-chip will be tailorable to different groups of women at risk.

WWW.MEDICALPLASTICSNEWS.COM

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SOFTWARE

Hand in hand Prosthetic manufacturer Steeper explains how incorporating new software into its processes has improved the creation of its award-winning product

inside and not the other way around. This approach meant they could focus on both functionality and aesthetics equally but to do so they required an integrated workﬂow between mechanical and electrical.

teeper manufactures innovative prosthetic, orthotic and assistive technology. Based in Leeds, its prosthetic development team has developed upper extremity prosthetics including its bebionic range and natural Skinergy coverings. The company also works in partnership with the NHS, as well as the London Prosthetics Centre to provide prosthetic services. The challenge To build the world’s most lifelike bebionic hand for the female, adolescent and Asian market. Steeper’s flagship bebionic prosthetic range currently features two hand sizes, large (measuring 200mm from middle finger tip to hand base) and medium (190mm). Market research revealed there was no hitech, multi-articulated prosthetics available for the smaller frame. Technical director at Steeper, Ted Varley said, “Some women would be wearing the medium hand because they wanted the functionality but the look and actual size of it wasn’t correct for them. We wanted to create something that would give them a true lifelike option.” The starting point for the design was a skeletal structure created from the hand of a 50 percentile American female. All the elements needed to fit into this volume. The bebionic small had to measure 165mm from middle finger to hand base and be a similar weight to a small human hand around 390g. A large hand could weigh around 600g. The challenge for Steeper would be in retaining all the functionality of the medium hand - including strength, robustness, ease-of-use and control - but with a 30% reduction in size. The design solution - modelling A design team of seven electrical and mechanical engineers worked collaboratively in Solidworks 3D CAD for all its conceptual and prototype designs of the bebionic small. “The digital surfacing in Solidworks facilitates our whole product design including the biological shapes we

Design collaboration Steeper did a lot of outreach with amputees at every stage of design and also with suppliers. With so many people working on the same product, it was key that its CAD management was fluid and their workflow processes were consistent.

POINT IT OUT: Steeper’s prosthetic development team has developed upper extremity prosthetics including its bebionic range

needed,” says Varley. “We could use some parts of the original medium hand, in other places we could use the same mechanisms but shrink them down, and then there were new challenges where we had to completely start from scratch. “We wanted to get into Solidworks as quickly as possible,” he adds. “We could have spent all our time devising the spec, but we felt our time as a team is better spent designing it and communicating. That is where Solidworks comes into its own. 80% of our design concept is done in Solidworks. It lets us get knee deep in designing without worrying about the tools we are using.” The prosthetics team used the Solidworks modelling functionality, including lofting, surface profiles and splines to produce drawings quickly and easily. Design integration The key thing for senior mechanical design engineer, Martin Wallace, was that the team designed the shell of the hand first, and then designed the mechanisms to fit WWW.MEDICALPLASTICSNEWS.COM

When it came to validating the design, the team used Solidworks Simulation to check and investigate any gaps and clearances to make sure there weren’t any clashes in the assemblies. “We used FEA software for testing the spring designs, but most of our tests was from a mechanical assembly point of view making sure it was all going to fit and move together,” says Wallace. The results After a two-year process Steeper launched the bebionic small onto the market. The device uses myoelectrical signals collected from the surface of the user’s skin to control movement. With 14 different grip patterns, it means the user can handle almost any situation including eating meals, opening doors and carrying bags. It provides a maximum grip of force of 140N and this grip opens and closes in less than 0.5s. It can support loads of 25kg per finger and a maximum safe load across the knuckles of 90kg. Individual motors in each finger means the hand can move in a natural, coordinated way. There is proportional speed control, which gives the user precision control over delicate tasks such as picking up an egg or crushing an empty can. While the auto grip function automatically senses when a gripped item is slipping and naturally adjusts the grip to secure it. In 2015 the bebionic small was awarded a British Engineering Excellence award for mechanical product of the year.

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EXTRUSION

WEIGHING N:

The pros and cons of processing methods for medical polymers

In line with the complexity of the finished product, developing a tool-grade steel mould, hot- or cold-runner blocks, and process automation equipment can be expensive upfront. However, at high volume and over the life of a program, the tooling costs per part can actually be quite low. Injection moulding, and even more so LIM, can produce high integrity parts over very high volumes.

ith bioﬂuid compatibility, favourable haptic as well as physical, chemical and processing Drew Rogers, Trelleborg attributes, Sealing Solutions, silicone’s looks at extrusion popularity for and moulding, and use in medical the advantages and devices disadvantages of continues processing methods for to grow. Advancements in medical polymer architecture further facilitate many novel nextgeneration medical devices and implants. Bringing together the ideal combination of material, component design and manufacturing process within the right framework of regulatory compliance is the key to fulfilling a device’s intended fit, form and functions reliably. Expertise from a silicone and polymer processing specialist, and due diligence at the early stage of concept and development, pay tribute later for timely and smooth market launch and industrialisation. We’ll review the advantages and disadvantages of several types of processing for silicone and medical polymers. 1. Injection Moulding Injection moulding allows highly efficient high volume manufacturing of components in – depending on sophistication of tooling – very complex and intricate geometries. Cavitation per mould is tailored from one to several hundred depending on complexity of part and capacity needs. A part and application may lend itself to be produced from liquid silicone rubber (LSR) in a liquid injection moulding (LIM) process. LSR has the potential to be used in combination with an engineered plastic using a 2-shot (or more) fully automated injection moulding set-up.

The moulding efficiency depends on decisions and choices made around mould and process design as to details such as cavitation, basic tool construction, gating, venting, surface finish, and supporting automation. It will also need to integrate seamlessly with equipment that pumps, mixes, injects, compresses, heats and ejects. Creating a mould for a seal to be used in a medical device typically requires early, close collaboration between engineering teams at the device maker and the seal supplier. This will ensure the correct material selection and adherence to regulations, while minimising variability, maximising yield, and reducing costs by optimising seal geometry, tooling and process engineering. Advantages of Injection Moulding  Liquid Injection Moulding

 Facilitates complex designs; ideal for parts with a large amount of detail such as undercuts or thin wall sections  Ideal for micro- and nano sized parts  Accommodates hard-soft combinations via a 2-shot LSR process  Highest efficiency of any molding method with short cycle times and possibility of full automation  Ideal for very high volumes in ﬂashless quality

Injection Moulding Enhanced strength; fillers can be used to reduce the density of the silicone while it’s being moulded, further strengthening the moulded part  Multiple silicone types can be utilised and tailored to the application conditions and molding process requirements  Metal or plastic elements can be integrated into the part  Efficient process for technical parts in medium to high volumes in semi-automation

 

Disadvantages of Injection Moulding  Liquid Injection Moulding  Highest initial tooling cost that must be considered as an investment over the life of a tool; which is, however, the longest of any type of injection moulding tool, i.e. typically one million shots  Injection Moulding  Design restrictions, including the fact that all parts must be solid and must have drafting if they are perpendicular to the tool opening  There may be restrictions on part thickness to avoid shrinkage problems  Requires part de-ﬂashing operation with additional cost 2. Compression moulding The compression moulding process is ideal for parts beyond the size capacity of extrusion or injection moulding and for moderately complex parts in low quantities.

WWW.MEDICALPLASTICSNEWS.COM

REPLACEMENT MARKET: Thanks to advances in thermoplastic polymers, plastic tubing is replacing metal tubing in many medical devices

Plastiward - Re-thinking in-plastic protection for plastic medical devices and pharmaceutical packaging

WEBINAR

Date: Thursday 7th December 2017 Time: 13:30 GMT, 14:30 CET, 08:30 EST, 18:00 IST Price: Free

Practical implementation steps to help stop fake drugs and devices getting into patients’ hands Patient safety is the top priority for all players in the pharmaceutical and medical devices industry. As part of their mission, many companies in the sector commit to providing access to safe medicines. The WHO estimates that up to 8% of medical devices and up to 30% of medicines on the market are fakes. During our first webinar, experts agreed it is a growing problem, and serialisation on its own is not the solution.

Speakers: Mr Steve Duckworth, Head of Global Segment Medical & Pharma, BU Masterbatches, at Clariant Plastics & Coatings Ltd, is responsible for medical & pharma products

Mr Yann Ischi, Director New Channels & Partnerships at SICPA, is responsible for security solutions for private-sector clients, including pharmaceuticals

• What happens when a medicine/device is a fake – even though it carries your brand name? • How can you stop fake drugs from getting into your patients’ hands? • How can you make field inspections efficient, so that you can take fast countermeasures? • How can you take advantage of your drug being delivered in a plastic medical device? Join SICPA, Clariant and Kroll for the second of a two-part webinar series. In this webinar, focusing on Plastiward, you will learn: • Why fast authentication in the field offered by Plastiward, is a key element in your brand security measures and protecting the patient.

Special guest from Kroll’s Business and Cyber Investigations team, specialising in digital investigations, including open source, and the tools and methodologies that enable clients to combat cybercrime, leaks of confidential information, counterfeiting, and intellectual property (IP) theft

www.medicalplasticsnews.com/webinars Can’t make the date? Sign up any way and we will send you an on demand copy after the event.

• What advantages the Plastiward real-time monitoring platform offers during an investigation process. • How Plastiward can be included in the protection of your medical device/packaging: close to the drug and low impact on design, regulatory, production.

Medical Plastics News is the voice of the medical plastics industry. It is an essential source of business critical, highly relevant and unique intelligence, which stimulates thought leadership and nurtures an innovative and connected community of industry stakeholders.

SICPA is a trusted global provider of security inks as well as secured identification, traceability and authentication solutions. With high-technology security inks at the core of its expertise, the company protects the majority of the world’s banknotes, security and value documents, and a wide range of consumer and industrial products. It offers solutions and services to governments and industry, ensuring product authentication, traceability and protection as well as tax reconciliation.

As one of the world’s leading specialty chemical companies, Clariant contributes to value creation with innovative and sustainable solutions for customers from many industries. Our portfolio is designed to meet very specific needs with as much precision as possible. At the same time, our research and development is focused on addressing the key trends of our time.

EXTRUSION

The process is used in medical applications such as diaphragms for respiratory equipment, lip seals for cylinder applications, and isolation bumpers used to inhibit vibrations. Compression moulding is also used to manufacture thermoset plastic parts. The raw materials for compression molding are either granules, putty-like masses, or preforms. The raw material is placed in an open, heated mould cavity to which pressure is applied, forcing the material to fill the cavity.

Advantages of extrusion  Accommodates high production volumes  Provides efficient melting  With plastics, allows for postextrusion manipulations  Offers considerable ﬂexibility in manufacturing products with a consistent cross-section

Advantages of compression moulding:  Cost-effective for smaller volumes; low tool costs  Parts can be made to customer specification from specified materials  Flexible mould design  Tools with multiple cavities can be created  Quick turnaround of tools and parts  Good surface finish

Disadvantages of extrusion  Difficult to predict the exact degree of expansion  Subject to size variances  Some product limitations

Disadvantages of compression moulding:  Slower part production rates  Involves largely manual process steps  Requires post-molding operations to remove ﬂash  Precision is good but limited to a normal level for rubber parts  Largely used for simple to moderately complex shapes with no undercuts A further option for production of moderate quantities of complex rubber part geometries is transfer moulding. Here, the elastomer is first heated in a pod to then be injected into the hot cavity. 3. Extrusion Silicone is well established as a completely inert, biocompatible and very versatile material in medical extrusion. In medical devices, both peroxide and increasingly platinum-cured silicone grades enjoy increasing popularity, the latter due to its increased purity and faster production cycle. Thanks to advances in thermoplastic polymers, such as polyether ether ketone (PEEK), polyurethanes, and polyolefins, plastic tubing is replacing metal tubing in many medical devices.

PEEK is an excellent alternative to stainless steel because it is very strong and has a low friction coefficient. Similarly, both PEEK and polyphenylsulfone (PPSU) are used for long-term implantable components because of their biocompatibility.

4. Multiple-Profile Extrusion (MPE) MPE eliminates secondary bonding operations through its ability to mate with a variety of tube profiles. The process produces a single, continuous tube, eliminating the need for leak testing. It also provides ‘on the fly’ manipulations, allowing the cross-sectional profile of a silicone tube to change during extrusion, reducing costs. The absence of a seam also greatly enhances product performance, mitigating areas where bacteria can accumulate. With MPE, there is no need for secondary bonding, thereby reducing costs and increasing production speed. Double extruder configurations allow for a range of stiffness and flexibility in tubes. The amount of flexibility can be controlled by thinning out the extrusion wall or switching to a softer or stiffer material anywhere along the extruded profile.

Within the MPE process, two or more lumens can easily be split off a center lumen or merge two lumens into a single lumen – all in a single continuous extruded tube. The multi-lumen process involves moving dies and mandrels in sync, reducing cross contamination of ﬂuids in the separate lumens. Advantages of multiple profile extrusion  Facilitates the extrusion of balloons of any length  Removes secondary bonding operations  Allows for seams to be eliminated  Various types of tubing (single lumen, multi-lumen, transitional GeoTrans, etc.) can be produced, as well as rod, ribbon, and other non-standard profiles  Suitable for extruding both elastomers and foams Conclusion The ability of silicones and thermoplastic polymers to be formulated and processed to attain specific performance, aesthetic, or therapeutic outcomes makes them ideally suited for many medical devices. Device designers and makers – either at OEM or CMO basis – need to have a basic understanding of the diversity of processing options available, or, better yet, bring on board from the early concept stage of a new device a processing expert for silicone and other polymer components. With time-to-market being such a critical element in the creation and sale of medical devices, the ability to produce rapid prototypes, quickly reach a final design, and consistently produce and deliver high-quality products, are the keys to success.

WWW.MEDICALPLASTICSNEWS.COM

Five reasons to visit the Med-Tech Innovation Expo

It’s the only event serving the £27bn UK and Irish medtech sector

The re-launched show in 2017 saw 2,000 attendees from 22 different countries and 150 exhibitors

The conference offers first-class presentations products in association with Medilink UK and Med-Tech Innovationmagazine

No other UK event brings together packaging, medical electronics, medical plastics, design, sterilisation, components and manufacturing equipment under one roof

It’s the perfect event to attend if you’re looking to source technology to help you design and manufacture medical devices!

12:2017

Out with a bang: The implant explosion causing ﬁreworks in the crematorium

HOT SHOT? Why is this device being called the Nespresso of auto-injectors?

t’s being called the Nespresso of autoinjectors…the new auto injector device from the Cambridge Design Partnership (CDP) called the Klarus, does all the prep work for the user so it’s ready to use when they need to inject themselves.

A report from the Journal of the Royal Society of Medicine (JRSM) has highlighted the number of pacemaker explosions in crematoriums. Apparently the number of artificial cardiac pacemakers is on the rise. And so is the number of explosions in the crematorium. The JRSM sent a questionnaire to all UK crematoriums to determine the frequency, consequences and prevention of pacemaker explosions. It says it found that around half of all crematoriums have experienced pacemaker explosions which may “cause structural damage and injury” and that most staff “are unaware of the explosive potential of implantable cardiac defibrillators.” There is currently a checking procedure to determine whether a body contains a pacemaker. However, only 5% of staff apparently know about the explosive potential of implantable cardiac defibrillators. The report says “54% believe a hand-held metal detector might help identify pacemakers and other implantable devices that could explode”.

Some patients might need to store drugs in the fridge, warm them up prior to injection, prepare the autoinjector for use and then dispose of the device safely.

With the Klarus, there’s no need to do this – the user simply takes it from its base station and returns it once they’ve injected. “Klarus will store drugs at the correct temperature and warm them up when required – minimising the pain of injecting cold medication. It will then prepare the autoinjector with the correct needle and medication cartridge, and prompt the patient to take their drug,” said Uri Baruch, head of drug delivery at CDP.

Check out...

‘changed beyond belief’ and she can now hear traffic, whistling, dogs barking and owls at night.

As the fourth person to receive one of these devices, Linda Oxley says her life has

The surgery was performed at Sheffield Teaching Hospitals NHS Foundation Trust by Professor Jaydip

he story about the woman who has had her hearing restored thanks to an ‘invisible; hearing device.

WWW.MEDICALPLASTICSNEWS.COM

Ray, a consultant ear, nose and throat surgeon. The Cochlear Carina hearing device is implanted into the fine bones of the middle ear, making it unseen from outside of the scalp.

5 THINGS TO CONSIDER

WHEN MANUFACTURING CONNECTED DRUG DELIVERY DEVICES The estimated number of connected drug delivery devices continues to increase and the impact of this trend could be significant, explains Phillips-Medisize

While digital connectivity or connected health can improve the coordination and delivery of patient care, original equipment managers need to keep these five things in mind when creating connected drug delivery devices: 1 2 3 4 5

Development strategy and design consideration Situation analysis and patient compliance Connectivity ecosystem Wireless subsystem Security of device and information

As the Internet of Things continues to become an integral part of people’s lives, the opportunity to use it within drug delivery device applications remains promising. The manufacturers and device designers must identify, investigate and overcome these challenges so that the implementation of wireless and other related smart technologies can be achieved. When done successfully, connected systems enable the patient and caregivers to have a 360° view of both the patient and the disease – not only to manage adherence, but to improve results by understanding the effect of the regimen.