MPN EU Issue 44

EUROPEAN EDITION

MEDICAL PLASTICS news

+ THE IRISH MEDTECH MARKET IN FOCUS 3D PRINTING THE LATEST IN ADHESIVES

How Schรถttli technology helps meet the diabetes epidemic demand ISSUE 44

Sept-Oct 2018

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CONTENTS Sept-Oct 2018, Issue 44

Regulars

Features

5 Comment Lu Rahman looks at innovation in the medical device sector

20 Made to measure Vancive Medical Technologies, discusses how early collaboration on material selection can lead to bespoke adhesives

33 Could wearables be the answer to an ageing population?

Accutronics looks at how they could help medical services manage longterm health conditions

23 What’s so special about Costa Rican medical devices?

Asks Lu Rahman

34 Fast worker Nidek Technologies slashes time-to-market with 3D printing

24 An expert view Microspec Corporation talks about the benefits and challenges of extrusion

37 Bone regeneration offers great potential

7 News analysis Lu Rahman examines how the Elvie Trainer medical device became a success story 8 Digital spy 16 Cover story Rising to the challenge: How SchĂśttli technology helps meet the diabetes epidemic demand 46 10:2018

27 Skin deep Netstal explains how its injection moulding machines are benefitting the manufacture of a diabetes device 29 What makes Ireland a major medtech player?

Reece Armstrong explains

39 Clean on me Trelleborg Sealing Solutions, explains how tests prove that the immersion method of production of implantable devices is effective 43 Shaping up nicely Jason Middleton, Ray Products examines thermoforming and the future of medical device manufacturing

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CREDITS head of content | lu rahman

As increasing numbers of us want products that combine functionality with the latest technology, there are opportunities to create devices with increasing relevance to today’s tech-savvy audience.

EDITOR’S

comment

deputy group editor | dave gray reporter | reece armstrong advertising | gaurav avasthi head of media sales life sciences & plastics | lisa montgomery art | sam hamlyn graphic design | matt clarke publisher | duncan wood Medical Plastics News is available on free subscription to readers qualifying under the publisher’s terms of control.

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Why evolution, not revolution could be the key to medtech success Who doesn’t love a success story? And I guess that the example of the Elvie Trainer which is now being supplied by the UK’s National Health Service Supply Chain, is a particularly fine case in point for me, given the way I’ve been championing femtech products over the last year or so.

What I love about this product designed to help treat stress urinary incontinence (SUI) - and its journey to the patient, is that it highlights that small developments can lead to big changes in how a product is viewed, and the way that the market therefore reacts to it.

Products that treat SUI have of course, been available for years. In that sense, the Elvie Trainer isn’t entering new ground or revolutionising the treatment process. However, by connecting the product to an app and allowing the user to receive feedback, it’s breaking the mould and offering the user something useful and tangible for a particular condition. The results speak for themselves – the product apparently leads to a 10% increase in both compliance and success rates, as well as helping reduce surgery rates by 50%. The end result is a saving to the NHS, per patient, of £424. It’s hard not to be impressed by those figures.

Digital devices and tech have been flooding the market for several years now. What the Elvie Trainer highlights is that it’s possible to take an existing concept for a product and make it modern to meet the expectations of today’s patient and to address the way that they, and the healthcare professional, want to use devices and engage with them for maximum potential.

When I’m out and about talking to medical device manufacturers or suppliers, I often hear that this sector isn’t full of trailblazing innovation.

Instead changes come slowly and incrementally. That may be true but in some ways it’s these incremental changes that are indeed trailblazing and are the ones that end up making a significant difference. It’s clear that we don’t need to redesign the wheel, but any changes that make it go faster, more efficiently and lead to cost savings, will be swooped upon, and rightly so.

It’s a situation that of course, doesn’t just apply to medical device manufacture and supply. As increasing numbers of us want products and services that combine functionality with the latest technology, there are opportunities to be had throughout all types of industry to create products with increasing relevance to today’s tech-savvy audience.

I find this aspect of the medical device sector increasingly exciting.

The possibilities are never-ending and with careful collaboration we could be looking at a raft of products that help treat a range of diseases and conditions just by increasing technology making it relevant to the user. Who knows where medical device evolution might lead us?

ISSN No: 2047 - 4741 (Print) 2047 - 475X (Digital) WWW.MEDICALPLASTICSNEWS.COM

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NEWS FOCUS

The route to the NHS how this femtech medical device got it right LU RAHMAN LOOKS AT THE RISE OF THE ELVIE TRAINER WITHIN THE MEDICAL DEVICE SECTOR AND WHAT’S BEHIND ITS LAUDABLE SUCCESS STORY

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he femtech trend has started to become a serious contender in the medtech field. And one product in particular - the Elvie Trainer – has started to show significant commercial success, with the UK’s NHS realising its potential. The Elvie highlights the way, with the right technology and marketing, certain products can be profitable within the healthcare market.

Figures from KPMG highlight just how valuable the femtech sector already is – it hit $55billion in 2015. It’s probably no shock that given the rise of technology within healthcare in general, female health has seen a growth in innovative, intelligent products that are helping women transform the way they access and understand their health issues.

Over the last few years the way all of us think about our health has changed. Monitoring our physical activity, heart rates, what we eat, has become the norm. Is it any wonder that women have seized the opportunity to track of their physical wellbeing with products that monitor periods, fertility, contraception and much more?

Products such as the Priya Ring, said to offer a ‘level of precision that no other ovulation prediction method can’, and the Ava fertility bracelet, have come to the fore. Suitable for use by consumers and healthcare professionals, the Ava device is designed to allow women to monitor periods, perhaps if they’re trying to conceive. Described as “an unprecedented method of tracking a woman’s cycle”, the bracelet collects physiological data while the user is sleeping, using this information to determine a fertile window.

However, the real runaway success in femtech is the Elvie Trainer, a connected device which takes women through a five-minute Kegel exercise to strengthen their pelvic floor muscles. It’s a simple but fantastic idea – taking a device that already exists in one form or another and adding technology to it to increase its appeal to the modern woman, making it relevant and current. In the medical device world we often hear that changes happen incrementally, rather than huge amounts of innovation hitting the headlines every

year. The Elvie is a great example of this, so much so, the device has been scooped up by the NHS. So successful is this concept, that the device has been picked up by the NHS which is making the product available to women with stress urinary incontinence (SUI) to help them strengthen their pelvic floor muscles.

The device is placed inside the vagina and connects to an app in which the user can receive biofeedback to help improve their technique. This is thought to improve both compliance and success rates by 10% as well as reduce surgery rates by 50%; helping to save £424 per patient.

Interestingly, research presented at the International Continence Society annual conference 2017 found that 80% of the women who used Elvie Trainer to treat a problem saw improvements and 98% did so in less than six weeks.

SUI is a common problem affecting an estimated one in three women which costs the NHS £233 million every year. SUI is the most common form of urinary incontinence and in the majority of cases can be reduced or eliminated by pelvic floor muscle training.

Hannah Rose Thomson, head of strategic partnerships and health, Elvie, said: “The availability of Elvie Trainer through NHS Supply Chain represents the opportunity to reduce costs to the NHS and improve outcomes for patients.

This is the first single-patient biofeedback for long-term use to be available to NHS patients, which will enable improved compliance between hospital visits and thereafter. Especially in light of recent events, we’re thrilled that the NHS is investing in tools to support conservative management of stress urinary incontinence and mild-moderate prolapse.”

Clare Pacey, specialist women’s health physiotherapist, Kings College Hospital NHS Foundation Trust, said: “I am delighted that the Elvie Trainer is now available via the NHS Supply Chain. It is a beautiful product, simple to use and the immediate visual feedback directly to your phone screen can be extremely rewarding and motivating. It helps to make pelvic floor rehabilitation fun, which is essential in order to be maintained.”

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DIGITAL SPY

DIGITAL

spy

www.ramgroup.com.de Will these sensors give silicone-based sensors a run for their money?

The technology, which might sound like something out of Dr Who, has been created following eight years of development which has seen the firm perfecting its quantum sensing technology, which it claims is a ‘post-silicon era solution to any enterprise aiming to bring advanced diagnostics capabilities to the healthcare industry or any IoT innovation across sectors’.

According to the business, silicon-based sensors can currently tell us ‘what’ with regards to physical phenomenon, Quantum sensors are the sensors of ‘why’ and can analyse exponentially deeper analytics. Ram’s sensing tech uses GaN (gallium nitride) in addition to a set of proprietary materials that create a sensor over one million times more sensitive in signal-to-noise ratio than anything currently in the market, enabling use cases ranging from telehealth for minimally invasive diagnostics and novel wearable devices, to a new range of physical phenomenon sensing IoT devices with

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convexityscientific.com FLYP OUT: HOW AN E-CIGARETTE HELPED PUT A NEW NEBULIZER DESIGN ON THE MAP

TECHNOLOGY UPDATE

The Ram Group has launched what it’s calling ‘quantum sensor technology’, as a competitor to siliconebased sensors.

DESIGN UPDATE

powerful data assets.

For example, its Home Health sensors include a Single Point Monitoring sensor that tracks continuous blood pressure, EKG with a novel signal, atrial and ventricular pressures, heart rate variability, and temperature without using electrodes and also includes a Smart Urinalysis application that can analyse nutrition, metabolics and allergies, for example. The introduction of the quantum hardware will enable more robust machine learning and artificial intelligence by providing a range and depth of data previously inaccessible.

Convexity Scientific prides itself on its ability to transform ‘medical devices with radical reinventions’ and that’s just what the company has done here. Nebulizers are devices that need to be plugged into mains electricity. As reported in Forbes this portable nebulizer, “was the brainchild of someone intimately familiar with the medical needs that surround COPD and asthma”.

chairman. According to Forbes, Finger “analysed the flaws of most nebulizers aside from their bulky size, like how many pieces they had and the difficulties of keeping them clean, and started to formulate his own idea for a smaller nebulizer that would be less cumbersome to use. He looked at inspiration across various fields and eventually found inspiration in an unlikely source: e-cigarettes.”

Dr Ralph Finger, is an emergency room doctor in New York City and Convexity’s current co-founder and

Now FDA-approved, the device has also scooped an award this year’s spring MedTrade expo in the US.

Apparently these sensors can be produced at one tenth the cost of silicon-based chips.

“Quantum sensors such as Ram Group’s have the potential to transform entire industries across healthcare, oil and gas, defense, communications and aerospace. Novel data economies as well as basic scientific insights in physics that will drive further innovations are possible due to Ram Group’s sensors.

The impact over the next decade will save lives as well as transform our economy,” said Dr. Jody Ranck, EVP global strategy, Ram Group.

DIGITAL SPY

www.thelancet.com www.ncbi.nlm.nih.gov New stent research reported in Lancet Manufacturers and developers of stents might be keen to read some new research published by the Lancet.

According to the publication: “Drugeluting stents combining an ultrathin cobalt-chromium stent platform with a biodegradable polymer eluting sirolimus have been shown to be non-inferior or superior to thin-strut, durable-polymer, everolimus-eluting stents in terms of 1 year safety and efficacy outcomes.”

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The findings came about during a “randomised, single-blind, multicentre, non-inferiority BIOSCIENCE trial” which “compared biodegradablepolymer sirolimus-eluting stents with durable-polymer everolimuseluting stents in patients with chronic stable coronary artery disease or acute coronary syndromes.”

To read more go to: https://www. thelancet.com/journals/lancet/article/ PIIS0140-6736(18)30801-8/fulltext

DIGITAL SPY

COLLABORATION UPDATE

PAEK practice: Victrex and the University of Exeter pave the way for additive manufacturing A 3D printing collaboration will focus on R&D in the pioneering pursuit of the full potential of high-performance polymers in additive manufacturing (AM) University of Exeter (UK) and Victrex, have begun a strategic partnership. The goal is to introduce next-generation polyaryletherketone (PAEK) polymers and composites while improving the performance of the underlying AM processes. This collaboration is driven by Victrex R&D and the University´s Centre for Additive Layer Manufacturing (CALM).

Victrex expects two industries to benefit in particular during the initial adoption phase, one of which is medical - AM in conjunction with PAEK will allow the manufacture of medical devices to make patient-specific implants.

“We are excited to start this partnership and continue our R&D work on development of high-performance materials and AM processes for today’s and future needs and applications. The new PAEK polymer-based materials will give designers and developers the opportunity to use the best performing polymers within AM processes and help make this dream a reality, transforming AM into a high-performance production tool,” said Professor Oana Ghita, the lead of CALM at the University of Exeter.

POINT

Potential benefits of using PAEK polymer for AM could include: • Greater design freedom for engineers looking to deploy AM in high-performance applications in a variety of industries.

• Higher-performance AM solutions, enabling the production of highly complex, highly customised, and highly specialised PAEK components.

• Digital design and fabrication of PAEK parts for rapid prototyping and speed to market.

• Improved economics through elimination of machining waste, improved refresh rates in powder bed fusion (PBF), and improved material utilisation in filament fusion (FF).

• Patient customised implants and improved outcomes through new features and better fit.

MATERIAL UPDATE

Hot off the press FLAME RETARDANT THERMOPLASTIC COMPOUND LAUNCHED

www.polyvisions.com PolyVisions has developed a highdurability, highly chemical resistant, flame retardant material designed for housings and enclosures in medical device and lab instrumentation applications.

talking

and flame retardancy not available in any material at any price today,“said Scott Howard, CEO of PolyVisions.

DuraPET FR is a graft-modified polyester compound capable of withstanding temperatures from -40°F to more than 180°F. It is designed with enhanced chemical resistance to withstand continuous exposure to germicidal cleaning compounds that destroy the properties of other commonly used thermoplastics.

PolyVisions says DuraPET is easy to mould due to its low shrinkage and excellent heat stability. It is currently used in parts ranging from 20 pounds to less than an ounce. Moulders have been able to use it in moulds designed for PC/ ABS and other materials. DuraPET is also suitable for film and sheet extrusion.

“DuraPET FR achieves a combination of impact strength, chemical resistance

Down the wire Study shows wireless pacemakers could cut patient complications Where has the research come from?

Cleveland Clinic. Its findings show that patients are less likely to experience complications using pacemakers that don’t use wires to connect the device to the heart.

Leadless pacemakers are small, self-contained devices that are placed directly into the heart using a catheter that is carried from the leg to the heart via the thigh’s femoral vein.

More than one million pacemakers are implanted each year globally. The first leadless pacemaker was introduced in 2014 and approved by the US FDA two years later.

Why are leadless pacemakers showing these results?

Conventional pacemaker models are connected to the heart using a wire that stretches from the shoulder vein to the heart. According to previous research, these wires are the most common source of complications for patients.

How did the study work?

The study compared short and mid-term complications between 718 patients receiving the Nanostim leadless pacemakers and 1,436 patients with conventional pacemakers.

At one month and up to 18 months, patients receiving the leadless pacemaker had fewer complications. They were found to eliminate lead and pocket complications, including infections.

What else do we need to know?

Looking at vascular complications, electrode dislodgement and generator complications, there were no significant differences between the two groups. The study did find however that those receiving leadless pacemakers had an increased risk of developing bleeding between the heart and the sac that surrounds it.

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Our Bormed™ portfolio of polyolefin solutions offers superior technical performance for medical devices, pharmaceutical and diagnostic packaging. We guarantee the security of our supply and provide technical support tailored to the specific and stringent requirements of the market. Furthermore, we offer a global service from our locations worldwide, ensuring fast and reliable delivery.

We are dedicated to the quality of your products – for the safety of patients – because we care.

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NEWS FOCUS

COULD SUPERBUG-KILLING POLYMERS BE ON THE HORIZON?

A new method developed at University of Warwick enables hundreds of polymers to be synthesised and tested for ability to kill superbugs

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undreds of polymers – which could kill drug-resistant superbugs in novel ways – can be produced and tested using light, using a method developed at the University of Warwick.

The discovery could speed up the discovery of new antimicrobials for a range of applications including medical and coatings.

Researchers from the Department of Chemistry and Warwick Medical School developed a way to synthesise large libraries of polymers, in such a way to make their screening for antimicrobial activity faster, and without the need to use sealed vials.

By using multiple ‘building blocks’ in their polymers, new antimicrobials were identified – some of which appear to inhibit bacteria growth, contrary to predictions.

The benefit of the method is that it allows screening of hundreds of different structures, enabling the researchers to ‘go fishing’ for new properties, which in this case was antibiotic activity.

Antimicrobials are essential not just in the treatment of internal disease and infections, but also in personal care products, such as contact lenses. There is growing awareness of antimicrobial resistance and the need to develop innovative solutions to tackle microbial infection.

Traditional antimicrobials (such as penicillin) work by inhibiting key cellular processes. The Warwick team, led by Professor Matthew Gibson, were instead inspired by host-defence peptides which are broad spectrum antimicrobials and function by breaking apart the membrane of bacterial.

Professor Matthew Gibson from Warwick’s Department of Chemistry and Warwick Medical School, also lead author of the paper, said: “Whilst many people have successfully mimicked antimicrobial peptides with polymers, the limiting step

was the number of different combinations of building blocks you can use. We used simple robotics and a light controlled polymerisation, which lets us do the chemistry open to air, without any sealed vials which are essential for most polymer syntheses.”

Dr Sarah-Jane Richards, from the Gibson Group at the University of Warwick and the lead author of the work, said: “We prepared the polymers in such a way that at the end of the reaction, we use the robotics to mix polymers directly with bacteria so we could look for unexpected activity, which we achieved.

“Surprisingly, the best materials do not seem to break apart the bacteria as we predicted, but rather inhibit their growth.

We are investigating this further.”

The research is published in the journal Chemistry; A European Journal. https://onlinelibrary.wiley.com/doi/ abs/10.1002/chem.201802594

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By using multiple ‘building blocks’ in their polymers, new antimicrobials were identified – some of which appear to inhibit bacteria growth, contrary to predictions.

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NEWS FOCUS

HOW US LIFE SCIENCE CEOS VIEW DIGITAL TRANSFORMATION AND AI COMPARED WITH GLOBAL PEERS

US CEOS MORE LIKELY TO SAY THEY ARE ACHIEVING RETURN ON INVESTMENT THAN GLOBAL PEERS, SAYS KPMG REPORT

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EOs of large life sciences companies anticipate quickly recouping investments in digital transformation and artificial intelligence (AI), while those in the US are expecting or have achieved quicker returns than their global peers, KPMG’s 2018 CEO Outlook found.

KPMG surveyed CEOs at companies with more than $500 million in annual revenue about their anticipated return on investment from artificial intelligence. This is a look at the results of 109 CEOs in the life sciences sector, which includes 40 based in the United States.

“Life sciences CEOs – and particularly those in the US – are much more optimistic about their digital transformation efforts than some of the other industries, because the ability to capture data more effectively is making medicine more personalized, effective and efficient,” said Liam Walsh, KPMG LLP line of business leader for healthcare & life sciences.

Most life sciences companies have made investments in AI in some form, according to the CEO Outlook.

US life sciences CEOs were also

more likely to see the strategic value of these investments – as opposed to the tactical value – than their global counterparts.

Among the US. CEOs surveyed this year, 25% said they have already achieved significant returns from AI investments and also digital transformation programs that have reshaped business functions such as product development, finance, IT, human resources, regulatory compliance, and marketing. Only 9% of global life sciences CEOs said they’ve already achieved a significant return on investment in artificial intelligence and digital transformation programs.

Another 33% of CEOs surveyed – both globally and in the United States – expect their investments in digital transformation to pay off within 12 months, the survey found.

AI AND LIFE SCIENCES JOBS Artificial intelligence and automation have traditionally been seen as threats to employment. However, 60% of US life sciences CEOs – 67% globally – see AI creating more jobs than it eliminates. The anticipated benefits from AI tend to vary by market, where the US based executives see cost savings and

Life sciences CEOs – and particularly those in the US – are much more optimistic about their digital transformation efforts than some of the other industries risk management as the biggest factor. CEOs outside the US see the technology helping their data governance and customer service.

“AI and other emerging technologies will transform how life sciences organizations operate in the future, since patients can be matched to more effective treatments and business processes can be made more efficient,” said Katie Dahler, KPMG LLP advisory leader for life sciences.

“The need for this technology in life sciences becomes more apparent in the ‘beyond the pill’ services that pharma companies are establishing to treat more complex medical conditions.”

KPMG surveyed nearly 1,300 CEOs at companies with more than $500 million in annual revenue, including 400 based in the United States for the 2018 CEO Outlook. For life sciences portion of the survey, 109 were surveyed around the world, including 40 in the United States.

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NEWS ANALYSIS

Why the hacking of medical devices is still big news LU RAHMAN LOOKS AT SOME OF THE ISSUES STILL AFFECTING CONNECTED DEVICES

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he vulnerability of medical devices to be hacked is nothing new. But picking up on news reports from the Black Hat security event that took place in Las Vegas at the beginning of August, it seems that these concerns continue to be top of the agenda where products such as pacemakers and implantable devices, are concerned.

The findings were brought to the fore by security experts, Jonathan Butts, QED Secure Solution, and Billy Rios, WhiteScope, during their presentation, Understanding and Exploiting Implanted Medical Devices. While acknowledging that benefits of these devices often outweigh the risks, the pair’s findings have been picked up on a global scale to highlight the need for increased work in this area.

Security Boulevard writer, Haidee LeClair, explained: “But there are still plenty of vulnerabilities out there, as well as—at least in some cases, according to Butts and Rios—resistance to acknowledging them and making necessary fixes.

“The two demonstrated that some devices they tested, including infusion pumps, pacemakers, and patient monitoring systems, had vulnerabilities that they found relatively easy to exploit remotely.”

While LeClair reports that “[Rios and Butts] have reported 500 advisories to vendors.

Most have been cooperative and worked with them on both “coordinated disclosure” of problems and fixing those problems.

“But they unloaded on one vendor— Medtronic, whom they said was both uncooperative and unresponsive. They said 18 months after they disclosed vulnerabilities in devices made by the company, there had been one patch but no real fix, and not even an acknowledgment that a fix was needed.”

In the UK, the Guardian reported that Butts and Rios had actually demonstrated how an implantable insulin pump could be hacked: “To take control of the pacemaker, Rios and Butts went up the chain, hacking the system that a doctor would use to program a patient’s pacemaker”.

It’s a worrying scenario but unfortunately one which we are used to reading in the medical device sector.

According to the Guardian, Butts and Rios contacted Medtronic over a year ago with their concerns. “In its cybersecurity alerts, the

company said the attacks weren’t possible remotely, and failed to fully explain how wideranging the weaknesses were. A bulletin warning about the weakness that Rios and Butts used to reprogram the pacemaker, for instance, said only that an attacker ‘could influence’ the data sent to its software update system,” reported the newspaper.

MPN contacted Medtronic for a comment.

The company said: “Medtronic emphasises the safety of its products. Product safety and quality are top priorities for Medtronic, and we have a strong product security program that leverages internal and external security and medical device experts, rigorous development processes and current practices to enable security and usability. We are, and continue to be, committed to delivering safe and effective devices to address our patients’ therapeutic conditions.

"It’s important to note, however, that the likelihood of a breach of a patient’s device is low, and we are not aware of any security breaches involving patients with our medical devices. All medical devices carry some associated risk, and, like the regulators, we continuously strive to balance the risks against the benefits our devices provide.

"Additionally, we value collaboration and transparency with industry partners and the regulatory community, and we support FDA guidance on these matters. Medtronic is committed to a robust, coordinated disclosure process and takes seriously all potential cybersecurity vulnerabilities in our products and systems, and we consistently seek to

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improve these processes, in terms of our technical evaluation, required remediation and speed of disclosure. We follow formal processes, as required by the FDA and other regulators, for evaluating and mitigating the risks associated with all cybersecurity vulnerabilities.

"In the past, WhiteScope, LLC has identified potential vulnerabilities which we have assessed independently and also issued related notifications. We are not aware of any additional vulnerabilities they have identified at this time.”

Earlier this year the FDA announced plans to enhance medical device safety. Its policies used real world evidence to create a framework for digital health devices.

Speaking about the decision, FDA commissioner Scott Gottlieb, said: “All medical devices have benefits and risks. And some of these risks are better understood once the device is more widely distributed and used under real-world conditions, in broader patient populations, and by a broader range of clinicians. Our aim is to ensure not only that devices meet the gold standard for getting to market, but also that they continue to meet this standard as we get more data about devices and learn more about their benefit-risk profile in real world clinical settings.”

One of the FDA’s key aims is to increase its understanding of cyber-security issues related to medical devices.

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COVER STORY

B. ENG. DOMINIK SINZINGER, SCHÖTTLI EXPLAIN HOW THE COMPANY’S HIGH PERFORMANCE MOULD TECHNOLOGY FOR PLASTIC PRODUCTS HELPS WITH DIABETES EPIDEMIC

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igh-performance injection moulds for challenging applications in medical technology require precision and skill. Schöttli, a Husky Company, constructs highperformance moulds in large quantities for medical applications including modern diabetes therapy.

Globally, as many as 425 million people, which is 9% of the world adult population, are affected by diabetes. The persistent high blood sugar levels of diabetics can lead to serious complications, including strokes, heart attacks, amputations, blindness and the necessity for dialysis treatments. Early diagnosis and proper diabetes management are critical.

The International Diabetes Federation (IDF) estimates that one in two cases of diabetes in adults has not yet been diagnosed.

Novo Nordisk, a global healthcare company, goes even further and describes a ‘Rule of Halves’. Of diagnosed diabetics, approximately only half are treated and only 50% of those treated actually receive the right amount of insulin at the right time. However, if diagnosed diabetics pay attention to their body, check their blood sugar level regularly and supply insulin accordingly, they can tolerate the disease well and live healthy, active lives. In the case of type 1 diabetes insulin must be administered, whereas type 2 may require insulin depending on the stage of the disease.

Currently, insulin cannot be administered orally with sufficient precision, so must be injected directly into subcutaneous tissue. Insulin is preferably administered in the smallest quantities tolerated (a few milligrams at a time), as precisely and regularly as possible. Precise measurement – or even better, continuous monitoring – of the blood sugar level is an important prerequisite for this.

PRECISE PLASTIC PARTS FOR DIAGNOSIS AND THERAPY A hundred years ago, a quarter litre of blood was required to determine accurate blood sugar levels. Today, there are devices as small as a smartphone and test strips that use only 0.3 μl of blood to provide an accurate blood sugar measurement. Syringes and pens allow diabetes patients to inject themselves with the precise quantities of insulin required to manage the disease. Insulin pumps work directly on the body, with complex sensors to determine and dose the insulin required.

Disposable syringes or pens are often preferred for insulin dosage, ensuring cleanliness and accurate dosing. In Germany, for example, about 80% of all patients administer their insulin with pens, while in North America or Asia, disposable insulin syringes account for around 80% of insulin administration.

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Disposable syringes for the administration of insulin usually consist of a cylinder with a firmly glued-in injection needle and a plunger. Here, Schöttli offers productive and reliable mould solutions with hot-edge nozzles and dual side gating for syringe cylinders, syringe plungers and similar applications, usually made of polyolefins.

As an alternative to disposable syringes, high-precision pens are often used for the subcutaneous administration of insulin. These ‘disposable pens’ consist of several precise plastic parts with a fixed insulin cartridge, with sufficient volume for several treatments. Slightly more expensive, but also readily available, are long-term pens with replaceable insulin cartridges. In either case, a new injection needle, which is screwed onto the pen-housing in conjunction with a pen needle-hub, should be used for each administration.

A needle is intended for a single administration and is then disposed of together with the pen-needle hub.

A pen needle-shield protects both the needle and the user from injuries immediately before and after use. For further protection and packaging, the pen needle cover is sealed with a film during transport (Fig. 1).

ADVANCED COMPONENTS WITH SAFETY MECHANISM An advanced needle type (safety pen-needles) is a slightly more sophisticated variant; these components are characterised by a special safety mechanism. A protective cap or shield automatically moves over the injection needle as soon as it is removed from the skin surface.

This effectively prevents needle prick injuries caused by carelessness. Because insulin is typically administered in a home environment as opposed to a doctor’s office or a hospital, ease of use and consumer protection for diabetes management is important. Another advantage of this type of protection mechanism is the effective prevention of multiple uses.

The manufacture of pen needle components and safety pen needles requires moulds that precisely produce these components, usually made of polyethylene or polypropylene. Schöttli provides expertise in high-cavity injection moulds for medical components. The company can offer corresponding single-face moulds for pen needleshields with up to 256 cavities. Pen needle covers and similar components can be produced on stack moulds with up to 192+192 cavities, maintaining the highest precision and highest performance (Fig. 2). Schöttli delivered the world’s first 192-cavity mould for pen needle hubs with side gate hot runner technology (Fig. 3).

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COVER STORY

With these products the needles, which protrude out of the hub on both sides, are subsequently glued in place in a fully automated process. This is a particularly challenging application, as the needles have very small outer diameters of down to 34G (34 gauge equals 0.18mm). This requires correspondingly small cylindrical openings in the injection moulded part and accordingly, tremendous precision in the injection mould. Each of the 192 cavities is centered individually so that the forming pins (gauge pins) do not break. Only in this way can the reliability of the molds, which Schöttli is known for, can be achieved. The resulting high level of availability and, depending on the application, unmatched number of cavities, leads to a significant increase in productivity per square meter of production area for the customer.

In the future, the control of blood sugar levels and the administration of insulin will increasingly be carried out by so-called ‘closed-loop systems’, which are precisely adapted to current requirements. With these systems, blood sugar level is measured with a sensor worn on the skin (Continuous Glucose Monitoring = CGM) and transmitted wirelessly to the pump. The pump doses the correct amount of insulin at the right time. As in other medical fields, the classical treatment method and modern online diagnostic systems are gradually converging in diabetology. Since too much insulin can be as dangerous as too little insulin, this innovation contributes to greater patient safety and fewer complications, thus reducing the global cost of diabetes treatment.

“This is particularly important because our customers do not want to produce two to three million plastic parts per year, but two to three million a day,” says Adolph Keller, managing director sales & marketing at Schöttli, “and with consistent accuracy.” Schöttli aims to produce moulds that offer maximum accuracy, consistency and adherence to the tightest tolerances. This is critical to ensure the high quality demands of the final product.

All moulds for the medical components presented here are equipped with Schöttli hot runner systems. Moulding is normally done in a cleanroom environment, with fully automated production surroundings.

FROM PUMPS TO THE ARTIFICIAL PANCREAS Insulin pumps available on the market today are usually worn on the body, with a ‘patch’ housing an appropriate injection needle stuck directly onto the abdominal wall. With these patches, which are usually worn for four to ten days, the needle remains under the skin. However, even when using pumps, the blood sugar level must be measured and controlled separately.

FIG. 3. 192-CAVITY ‘SINGLE FACE’ MOULD FOR MANUFACTURING THE PEN NEEDLE HUB © SCHÖTTLI

REFERENCES 1 http://www.diabetes-managen. de/?gclid=Cj0KCQiAkZHTBRCBARIsAMbXLhHZJp_ ZH4tGFL8lT29_ PZi9Sv9YJnLyRaU_wOsjx6xFKNfWtThiUkaAnRAEALw_ wcB (01/01/2018) 2 https://www.idf.org/about-diabetes/ what-is-diabetes.html (01/01/2018) 3 https://menschen-mit-diabetes.de/ (01/01/2018) 4 https://www.novonordisk.com/aboutnovo-nordisk/novo-nordisk-inbrief/ stories/leadership/rule-of-halves.html (01/01/2018) FIG. 1. KEY COMPONENTS OF THE INSULIN PEN ARE USED FOR FIXING THE INJECTION NEEDLES AND FOR PROTECTING THE PATIENTS AGAINST ACCIDENTAL INJURY BY THE NEEDLES © SCHÖTTLI

5 Focus Diabetes, Nr. 3/2015, Focus Magazin Verlag, Munich, Germany 6 http://diabetesmuseum.de/blutzucker/ blutzuckermessung-vor-1964 (01/01/2018) 7 https://www.medtronic-diabetes.ch/de/minimedprodukte/minimed-640g-insulinpumpe (01/01/2018)

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HEAT TRANSFER

HOT TOPIC

GETTING TO GRIPS WITH HEAT TRANSFER SYSTEMS DAVE DYER, TECHNICAL GLOBAL HEAT TRANSFER, EXPLAINS HOW A DETAILED UNDERSTANDING OF A HEAT TRANSFER SYSTEM CAN HELP MANUFACTURERS MAINTAIN EFFICIENCY AND PREVENT COSTLY DOWNTIME

S

ome paintings reveal more detail the longer you look at them. At first, you see a countryside landscape, then you spot a face hidden in the scene. Optical illusions both confuse and intrigue but there are other systems that are more detailed than they first appear. If manufacturers look in more detail at their heat transfer systems, they may find problems they could prevent.

When operating in facilities that use heat transfer systems, manufacturers must ensure their plants run safely and efficiently to meet equipment regulations. However, in many ways, regulatory compliance is only a minimum in terms of safety checks and maintenance.

The better the operator’s understanding of the system, the more able they are to spot issues early and prevent costly downtime.

To avoid problems that cause safety hazards and system failure, everyone in a manufacturing plant should know the specifics of the systems they work with. Staff training should include the basic functions of the system and the best practice for plant maintenance to optimise productivity. Starting up and shutting down a heat transfer system, for example, are fundamental skills needed to ensure efficient production.

the system to regulate temperature and adapt to the product specifications.

SAFETY A clean working environment aids productivity and keeps workers safe. Manufacturers can improve plant efficiency by cleaning and fixing leakages immediately as well as using the correct equipment based on temperature and other environmental factors. Leaving oil spills unattended or using plastic equipment can be a health and safety hazard.

As well as protecting workers through cleanliness, purchasing and maintaining safety equipment can improve the efficiency of the heat transfer system. Spray guards are used around flanges and known potential leak points, causing the oil to coalesce back to a liquid and rendering it non-hazardous. This makes the leak safe but visible so manufacturers can solve the issue.

RISK MANAGEMENT Though a system is only required to have one major and one minor service a year, plant managers have a lot to gain from proactive maintenance.

Staff should proactively check the system as frequently as possible to look for wear and tear, leaks or other changes.

Some visual checks denote external issues, yet visual cues such as inconsistent heating of final products, may be an internal maintenance issue. A lack of representative fluid analysis and proactive maintenance can lead to fluid degradation and carbon forming in the system.

Implementation of a continuous maintenance programme for thermal fluid, such as Global Heat Transfer’s Thermocare, can reassure manufacturers that it is not the fluid that has caused production issues.

THE INS AND OUTS The main function of a heat transfer system is to distribute heat around a facility and to specific areas of the production line. The heating process begins at the main heater, which is comprised of a burner and coil which is cited inside the heater.

The burner heats the coil containing the heat transfer fluid. A pump circulates the fluid through the system and controls the pressure.

This main circuit of the system allows the fluid to travel around the plant efficiently, but more components are needed to ensure the system is safe and stable to use.

Looking at a heat transfer system alone is not enough to maintain its efficiency. Just like an optical illusion, studying each component reveals more details.

With knowledgeable, trained staff and preventative maintenance, manufacturers can optimise productivity of their heat transfer system, creating satisfaction for workers just like when you spot both hidden images in an illusion.

One of the most overlooked pieces of equipment in the system is the gasket, which connects flanges that seal the system containing the fluid.

At any sign of gasket failure, the heat transfer system must be shut down to prevent hazards and to isolate the issue. Automatic valves are also in

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ADHESIVES

Made to NEAL CARTY, VANCIVE MEDICAL TECHNOLOGIES, DISCUSSES HOW EARLY COLLABORATION ON MATERIAL SELECTION CAN LEAD TO BESPOKE ADHESIVES — A PATH THAT MAY SAVE SOME HEADACHES IN THE LONG RUN

A

s functional demands on medical devices become more complex, device developers may struggle to find standard, offthe-shelf adhesives that can help them achieve their desired product performance requirements. This article guides developers through some basic considerations to keep in mind during material selection and when partnering with a supplier to get it right the first time.

Product development engineers live in a world of accelerating timelines, shrinking resources and impossible expectations. And they thrive on it. Delighting their customers and fueling their next recordbreaking quarter is what drives them, and they know that winning means using every tool available to be leaner and more innovative in their work.

CUSTOM DOESN’T HAVE TO MEAN SLOW When designers need to specify adhesive materials, the thought of going down a path of customisation may sound daunting. Under the pressure of an aggressive project schedule, intuition says that an “off the shelf” choice will be faster and simpler. But this is not always the case. An optimal solution to a specific problem often requires some degree of customisation, and it’s important to consider that not every custom product involves the creation of brand new chemistries. There are many cases in which existing adhesives and materials can be combined in new ways.

In other words, a materials supplier may be able to ‘mix and match’ different backings, release liners or adhesive types to achieve the desired performance. By doing so, the device developer can walk away with an adhesive product uniquely specialised for a certain end use, without reinventing the wheel. Certainly, there are also cases that call for development of a completely novel adhesive chemistry, and this can require a closer R&D partnership to co-engineer a solution.

Either way, it’s good to engage with suppliers early and leverage their knowledge and experience to solve a particular development problem or achieve a desired clinical outcome.

EARLY COLLABORATION AND OPEN INNOVATION More medical device businesses are embracing the theory of open innovation as a means to reap the rewards of proactively seeking and incorporating input from experts outside of their own organisations.

This can apply to the selection of custom adhesive materials during medical device design and development.

A fundamental tenant of open innovation, as explained by one of the movement’s forefathers, Henry Chesbrough, executive director of the Center for Open Innovation, Haas School of Business, University 20

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o measure

ADHESIVES

When off the shelf won’t do of California, Berkeley, is that: “…firms can and should use external ideas as well as internal ideas, and internal and external paths to market, as the firms look to advance their technology.”(1) In other words, firms can and should leverage the entire universe of resources that is available to advance their goals, not just the ones they have in-house.

When device developers and their supply chain partners undertake a design challenge from this perspective, they seek answers from sources who hold the greatest expertise in a specific area. For example, medical device design engineers who need adhesive materials to enable multi-day or multi-week wear times on the skin will benefit from going straight to the suppliers who know the world of possibilities and have the accumulated experience of solving similar problems across a wide array of different applications. In turn, those suppliers should be seeking input from their raw materials suppliers. Each node of the supply chain has the potential to add a new perspective to the conversation. Without this first-hand advice, designers and developers can miss out on key advances and answers

that could shorten their development times and help their product perform better for the patient.

AVOIDING THE ‘SHOTGUN’ APPROACH In the rush to get products to market, sometimes development teams will request myriad material samples and embark on a program of brute-force experimentation to achieve a desired outcome. This can be referred to as the ‘shotgun’ approach in that companies’ parallelpath testing of a wide array of materials. Sometimes this is effective, but it can quickly sap precious resources and by short-circuiting a process of thoughtful design it can also lead to suboptimal solutions.

Often, design engineers can save considerable time and effort by first talking with materials suppliers about their end goals. For instance, it may be very straightforward for a supplier to make changes to an adhesive tape construction: eliminating layers, changing chemistries, or using innovative techniques to give it greater breathability, stronger hold or better conformability — or even something as simple as a different color. By communicating about the end use application early in device development, all parties have an opportunity to avoid designs that are unnecessarily complex or costly.

complex biometric systems, such as for glucose or cardiac monitoring and drug delivery. Electrical engineering is crucial for understanding device battery life, wireless communication and many other core functions.

Whether it’s wearables or wound care, tapping into insights from different subject matter experts can have a big impact on product development. Particularly within the medical device industry, good engineering must go hand-in-hand with an in-depth understanding of the regulatory environment. For example, a medical materials supplier with deep materials science experience in the medical market and a working knowledge of global regulations may be able to help a device developer save time and effort by recommending design approaches that operate within allowable regulatory boundaries.

In conclusion, when supply chain partners pool their resources and diverse talents, they can tap into a wealth of multidisciplinary expertise. If off-the-shelf solutions are insufficient to achieve target outcomes, an open innovation approach may prompt device makers

and materials suppliers toward custom adhesive development. When this option is explored early, it can help device developers to solve problems better and deliver new patient solutions in an even more efficient way.

Footnote (1): Henry Chesbrough, “Open Innovation: The New Imperative,” as cited on the Open Innovation Community’s website

OPEN INNOVATION CAN ENABLE MEDICAL DEVICE OEMS TO SECURE CUSTOM ADHESIVE FORMULATIONS FROM COMPANIES WITH EXTENSIVE ADHESIVE TECHNOLOGY

OPTIMISING DIVERSE EXPERTISE Just as the best medical devices and materials are ultimately fit for a specific purpose, the different teams, partners and individual contributors who develop them serve unique roles toward the end goal. For example, wearable device developers need deep knowledge of process engineering to ensure designs can readily scale up to high-volume manufacturing levels. They need polymer and materials science experts to help them achieve the desired wear time, a conformable hold and comfortable release from the skin when it’s time to remove the device. Biochemical engineering and physiologic expertise is essential to ensure proper functioning of WWW.MEDICALPLASTICSNEWS.COM

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OVERSEAS MEDTECH

What’s so special about Costa Rican medical devices?

LU RAHMAN LOOKS AT THE EXPERTISE ON OFFER FROM THE COST RICAN MEDICAL DEVICE MARKET

T

he Costa Rican medtech sector really came to our attention on MPN at this year’s MD&M East, New York, via the CR Med Supply Consortium exhibiting at the event.

Made up of 10 medical companies, the CR Med Supply consortium took part in the show to highlight the growth in the country’s medical device industry.

Costa Rica currently boasts 96 companies that export medical devices. Last year, medical and precision equipment was the most-exported category of goods in Costa Rica.

The aim of the Costa Rican delegation was to show how the country offers experience in medical device manufacturing, traceability, validation, process stability, just-in-time deliveries, logistical efficiency, cost-reduction programs, quick responses, plus a strong culture of quality and innovation.

The ten companies at the event also demonstrated how they can provide a solution to supply chain challenges that industrial multinational companies in Costa Rica are facing. The consortium has also worked alongside the Costa Rican Trade Promotion Agency (Procomer) to help expand the group.

Alvaro Piedra, director of exports at Procomer, said: “In Costa Rica we have been working to develop the abilities and competitiveness of the companies that supply the manufacturers of medical devices. Our country is very attractive to the multinational companies in that sector, and we are proud of the advances and commitment to quality that the consortium has demonstrated. Through CR Med Supply, medical device manufacturing companies around the world can access the ample and reliable supply chain that Costa Rica offers to OEMs to meet their needs related to machined parts, injected plastic, adhesive stickers, calibration, automatisation, assembly, and packaging.”

An example of Costa Rican medical device expertise can be found via Advant Medical - a global player in medical device contract services and manufacturing solutions. Earlier this year it announced a significant investment for a Costa Rican expansion.

This included a 13,000 square foot facility with a 2,200 square foot, Class 8, cleanroom with capacity to manufacture Class I, II, III medical devices. Advant has also invested heavily in equipment and machinery to support its manufacturing capability in the region.

widely regarded for its expertise in medical devices in leading neuro-revascularisation device assembly, catheter assembly incorporating electro-mechanical drive systems and high-end, high volume specialty dispenser manufacturing.

The minister of foreign trade, Alexander Mora, said: “The medical devices sector has allowed Costa Rica to occupy more sophisticated connections in global value chains that are much more sophisticated and robust. In the past five years, medical devices became one of our main export products, increasing by 78% the shipment of these products abroad. Thus, we have positioned ourselves as regional leaders in quality, efficiency, experience and productive innovation. As a result, the country has been able to attract and make possible investments of leading companies in these productive processes. Advant Medical, with over 25 years in the market, has positioned itself, internationally, as a leading provider of high quality within the sector. In that value proposition, we are very proud that Costa Rica has a key position in its strategy, to attend one of its main and most demanding markets. As central government, we receive this news with great joy, and we wish the best successes to the company.”

Speaking about the new Costa Rican venture, Bob DiPetrillo, CEO, Advant Medical said: “With a positive foundation from our initial experience in the country through a contract manufacturing partnership, we have a great appreciation for the excellent business and political environment that operates within Costa Rica.”

Jorge Sequeira, managing director of CINDE, commented: “During 2017, the life sciences sector, to which Advant Medical belongs, represented almost 20% of the investment projects that established in the country and that generated a total of 22,400 quality jobs. We are sure that Advant Medical will find in Costa Rica a strategic partner to make its operations grow.”

Headquartered in Galway, Ireland Advant Medical is a global partner and tier one supplier to multi-nationals, SMEs and start-up companies across the globe.

“With the support of CINDE along with our other strategic partners, this investment in Costa Rica provides a tremendous growth opportunity and a platform from which Advant will continue provide world class medical device contract and manufacturing services,” explained DiPetrillo.

The company offers medical device packaging and subcontract manufacturing for the medical device industry. The company is

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EXTRUSION

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EXTRUSION

AN EXPERT VIEW TIM STEELE, MICROSPEC CORPORATION TALKS TO MPN ABOUT THE BENEFITS AND CHALLENGES OF EXTRUSION AND WHY OEMS SHOULD TAKE THIS PROCESS SERIOUSLY

WHY SHOULD DEVICE MANUFACTURERS CONSIDER EXTRUSION AS A MANUFACTURING PROCESS? TS: I believe that device manufacturers have always considered extrusion as a process central to the development and fabrication of medical devices. With regard to many advanced devices this fact would be difficult to overstate! For this reason, many of the device manufacturers vertically integrate extrusion into the matrix of their manufacturing processes not just to possibly save money but to gain added insight into the relationship of the dynamics in the extruded part and how those dynamics affect the fabrication processes in manufacturing a medical device or catheter.

Here it is important to keep in mind that there is far more to an extruded tube than its dimensions. How a tube is extruded will affect most if not all of the manufacturing processes involved in fabricating devices. In the case of the catheter device pictured below, how the tube was extruded will affect the printing on both the catheter body and the extensions. The tipped distal end involves two lumens and two different materials, a clear polyurethane and two barium filled radiopaque stripes. The proximal end of this tube is over moulded and bifurcated and connected two over moulded extension tubes. For successful tipping and over moulding, the dimensional attributes of the tube must be to specification to ensure smooth uniform tips. The criticality of the dimensional attributes involve more than just an inside diameter (ID) and an outside diameter (OD), but include the location of the stripes and the positioning of the lumen, which must be to specification for tipping and over-moulding to be successful.

Thermal characteristics of the raw material is another important consideration when tipping and over-moulding and also should be considered if the part is to be ETO sterilised. With many elastomers, part dimensions can change when exposed to the heat the part is exposed to during sterilisation, or the heat it may see in a shipping container. This happens because when plastic is drawn down and cooled there is stress frozen into the plastic. To relieve this stress extruders often anneal parts.

The part dimensions will change during annealing, but the latent stress in the tube is now gone and future dimensional changes from heat are eliminated.

In the design stage of an extrusion process for a new part it is useful to create a matrix of the desired attributes of form and function a particular part may be affected by the extruder and the process.

Process control in extrusion must be anticipated. This involves having a thorough and intuitive understanding of the interaction of the raw materials with the extruder and the extrusion tools. Monitoring and saving all process data is critical to developing and validating the extrusion process as it is with any manufacturing process WHAT MATERIALS DOES THE PROCESS WORK BEST WITH AND WHAT ARE THE ADVANTAGES OF THE TECHNOLOGY? TS: I do not see that any particular material works best throughout the medical device industry. Although there are several families of

materials that are used extensively throughout the device industry, I would have to say that the raw material selected for extrusion of a specific device depends on requirements of the device’s application. Physical characteristics generally considered first would be shore hardness, flex modulus, tensile strength, melting point, and service temperature. The matrix of material characteristics after that is specific to every application and what would work best in extrusion is largely based upon the competencies of the extruder. In short, what may work best for one extrusion company may not work best for another and to summarise this there is no best material. The use of custom formulated raw materials has been growing, along with the increase in highly specialised devices and advancements in antimicrobial compounds, advancements in drug delivery, and innovation throughout the medical industry.

HOW SOON IN THE DESIGN PROCESS SHOULD THE USE OF EXTRUSION BE CONSIDERED AND WHY? TS: Engineering design teams need to start considering extrusion requirements while brainstorming in the concept stage. Having the extrusion expert on the design team and participating in brainstorming during concept development will enhance concept development.

This collaborative communication during the design phase helps the device maker more fully understand what is possible, but also gives the extruder a deeper understanding of the device maker’s expectations.

The client and the extruder both benefit and the device gets to market faster.

WHAT ARE CHALLENGES OF THE PROCESS AND HOW CAN THEY BE OVERCOME? TS: In the custom medical extrusion world there is not one formula the extruder follows to troubleshoot the extrusion challenges in producing the array of parts being demanded by today’s medical device industry.

The devices continue to get smaller and smaller with precision becoming more and more critical.

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It is the same with functionality.

Overcoming new challenges needs to be a collaborative process between the customer (device maker) and the extruder.

Overcoming new challenges starts with good communication.

Both parties need to have good understanding of the issues so that solutions are based upon intuitive decisions. Of course, both the device maker and the extruder have IP so a Mutual NDA is the first item in the development of a collaborative relationship based upon trust and the knowledge that both sides win by working together.

Sharing knowledge is critical to success and both the extruder and the device maker need to be open with each other without giving away trade secrets.

HOW CAN EXTRUSION EXPERTS SUCH AS MICROSPEC SHARE THEIR KNOWLEDGE WITH DEVICE DESIGNERS AT AN EARLY STAGE AND THEN CONTINUE TO MANAGE CUSTOMER EXPECTATIONS THROUGHOUT THE PROCESS? TS: By participating in brainstorming during concept development of a new device we have experienced increased openness with our clients. With this our working relationship is strengthened which both sides in understanding the challenges we share in the project.

As part of our extrusion service, we offer free technical advice when the client runs into technical problems and, if we do not have the answer, then we will refer to our own network of materials experts to find the answer and get back to the client.

SUMMARY: In the medical device industry, the extrusion process and the extrusion engineer are integral to the development of the ever increasing advanced medical devices. The extrusion process is innovating along with the device technology.

Sharing knowledge of how extrusion affects device fabrication is critical to making intuitive decisions which will ultimately minimise the time to market for a new medical device.

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INJECTION MOULDING

Skin deep Dr. Sabine Kob, Netstal explains how Netsal injection moulding machines are benefitting the manufacture of a diabetes device

D

ue to the nature of the parts it manufactures using injection moulding – high quantitities of complex shapes with narrow tolerance ranges - Weidmann is using 19 continuously running Netstal machines.

Diabetes is a widespread disease with high global growth rates, and individuals suffering from it have to check their blood sugar on a regular basis.

The FastClix device is designed remove blood without causing pain. Instead of the tip of the pen, a lancet extends from the housing, pricks the skin and disappears - all in three milliseconds.

At Weidmann Medical, the sophisticated inner workings of the FastClix system are produced on an Elion with a clamping force of 120 tons as well as a 100-ton Synergy.

DECADES OF PARTNERSHIP The relationship between Weidmann Medical and Netstal goes back to the end of the 1990s, when a 90-ton Synergy was commissioned.

This is still in operation. Today, 19 Netstal machines are running at the Weidmann production site in Bad Ragaz. Most of them are equipped with the Med-Kit, which better protects the products from

dust contamination and makes it easier to clean the plants. Many of them are located in cleanrooms with an ISO class of up to 7.

Due to the short distance between Netstal and the medtech specialist, mould proving, commissioning and service tasks can be performed quickly and in close cooperation.

Partly because it is located in a highwage country, Weidmann Medical has automated much of its production. In addition, all components are subject to a 100% in-line camera inspection. In four shifts, 115 employees work seven days a week and produce approximately 500 million parts annually. As part of the Wicor Group, which has 3,100 employees, Weidmann Medical carries out business across the globe and operates its own plant in Mexico. Due to its size and because its specialises in the medical sector, the company says it can react flexibly and immediately to customer inquiries.

22 COMPONENTS - ONE SYSTEM The complex shapes of the parts were the main challenge for the production of FastClix, as project manager Thomas Epp explains: “In order for the push and twist mechanism to work flawlessly, no burrs may form at the components.”

THE FASTCLIX LANCING DEVICE HELPS PEOPLE SUFFERING FROM DIABETES TO MONITOR THEIR BLOOD SUGAR LEVELS. PHOTO COURTESY OF WEIDMANN MEDICAL

The components consist of PBT (white articles, see photo) and ABS (grey) and are produced in 16 or 24-cavity moulds.

The lancet system, which consists of 22 components, features needles for blood removal in six bays. The user can adjust the prick depth at the pen and, after each use, they can choose whether they want to select a new bay – and therefore a new lancet – or not. Once all six needles have been used, the inner workings of the FastClix system are discarded as a disposable item and a new one is inserted. Customers can purchase these inserts as a ready-to-use item straight from Weidmann Medical. Millions of these completely assembled drums are shipped from the plant in Bad Ragaz annually. These large quantities can only be produced with reliable machinery.

“We value the high availabilities of Netstal plants and that we have very few technical problems. They just keep running, are extremely reliable and have long service lives,” says Epp. PROFESSIONAL SYSTEM PARTNERS What unites Weidmann Medical and Netstal – in addition to the machines – is their aim to work in partnership with their customers The medtech manufacturer focuses on the development of high-end technical plastic injection moulding components and not only implements its own product ideas but also designs using customers‘ ideas.

The goal is to be involved early on in projects to uncover the optimal manufacturing process. For the main markets in Europe and the US, the production can also be done internationally upon request.

The products include sealing systems for syringes as well as high-precision components for in-vitro diagnoses or special pacifiers for premature babies. In many cases, assembly and packaging services are added to the injection-moulded products. With this portfolio, Weidmann Medical says it has established itself as a partner of globally renowned pharmaceutical and medical technology companies.

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IRISH MEDTECH

THE HUBS It’s no surprise that medtech companies have flocked to Ireland. Through the country’s EU membership, companies have access to a European market consisting of over 500 million potential customers. And Ireland’s commitment to invest over €5 billion in science and technology research in Ireland by 2020 shows a country dedicated to the sector.

What makes Ireland a major player in medtech?

REECE ARMSTRONG EXAMINES WHY IRELAND IS A MEDTECH HOTSPOT AND WHAT TO EXPECT FROM THE COUNTRY IN THE FUTURE

I

reland is one of the world’s major medtech hubs, hosting 18 of the world’s top 25 medtech firms and exporting over €12 billion of medical products every year. To many, this country represents a blazoning example of forward-thinking and growth in a competitive market.

Ireland’s medtech origins can be traced to a number of different roots but perhaps the most important is the development of IDA Ireland, a government body designed to stimulate exportled business throughout the country. Since its formation in 1949, IDA Ireland has encouraged businesses to set up in Ireland, helping to develop the country’s economy and export market.

A major win for medtech in Ireland came from IDA securing a contract with global firm Schering-Plough to deliver biotechnology-derived pharmaceutical products; a fundamental moment in Ireland’s medtech history.

Now, as the second largest exporter of medical technologies in the world, Ireland is an established medtech hub. But who are its major players, where are they, and what can we expect from Ireland in the future?

It’s not just Ireland’s homegrown companies that are finding success. A partnership between Enterprise Ireland and Mayo Clinic launched in 2014 was designed to commercialise 20 US medtech products whilst creating ten spin-out companies in Ireland.

Inform BioScience was one of the first spin-outs to benefit from the partnership and in 2014, Inform BioScience signed a license agreement with the Mayo Clinic so it could develop a urine test to detect preeclampsia in pregnant women.

Ireland has a diverse set of locations from which medtech companies are operating. Whilst Dublin is home to a large number of medtech players, many companies are opting to base themselves in regions outside of the capital.

Galway’s medtech scene shows a web of companies all within striking distance of each other. Major players such as Medtronic, Boston Scientific and Creganna operate within Galway, alongside the 8,333 medtech employees that work within the city.

With the West of Ireland accounting for 39% of all medical device employees in the country, Galway has played a strong role in developing its medtech cluster. As the second largest hub for medtech in Ireland, it is home to both major medtech companies, exciting start-ups and the Cúram, Centre for Research in Medical Devices; touted as Ireland’s ‘super centre’ for developing the next generation of smart medical devices.

Cúram has been active in many areas of medtech and throughout the past two years has managed to develop a potential new treatment for lower back pain; formalise a partnership with the Korean Institute of Industrial Technology for education in biomedical manufacturing and scoop up Ibec’s ‘Academic Contribution to Medtech Award’.

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IRISH MEDTECH This year, manufacturer of rapid diagnostic testing solution, Quidel, announced the creation of a Business Service Centre in Galway. The centre is set to create 75 jobs over the next five years; a small but essential contribution to the 4,000 extra medtech jobs being targeted by business lobby group Ibec , by 2020.

For Creganna, TE Connectivity, Ireland offers a location in which it can easily connect with other medtech companies, as well as potential customers.

“As a medical device outsourcing partner, Ireland offers the benefits of co-location with leading medical technology companies. This close proximity benefits Creganna, TE Connectivity and our customers through regular local access and expedited support for design, development and manufacturing programs,” the company’s director, commercial, Jeff Stanton said.

But what is it specifically that attracts medtech companies to Galway? Well it could be the talented employees that are flocking to the city; since 2015, a 70% increase in Dublin-based tech workers looking at jobs in Galway has been noted .

And according to Sheila O’Loughlin, senior market adviser for Enterprise Ireland, Galway, “where a third of Ireland’s medtech employees are based, is undoubtedly the epicentre of activity and home to the BioExel Medtech Accelerator, the first of its kind in Ireland to focus solely on the medical technology sector.”

Designed to attract the best medical technologies currently being developed, BioExel offers €95,000 in seed funding to help applicants build and bring their products to market.

Galway seems to the perfect location for collaboration with other businesses, but more importantly, Ireland as a whole has a “dynamic ecosystem where academia, industry, clinicians and government work together closely, enabling Ireland to flourish on the global stage,” according to O’Loughlin.

Take for instance, the employment opportunities that are being made by medtech companies. Ireland’s employment rates for graduates recently returned to levels last seen during the economic boon and 60% of graduates go on to work somewhere within Ireland .

In Limerick, Becton Dickinson announced that it will hire an additional 85 staff for its R&D centre. Meanwhile, further north, Abbott is hiring 500 staff to help expand operations for developing devices to treat and manage diabetes.

Considering that the total number of people living with diabetes in Ireland is estimated to be over 200,000 Ireland offers a major market for companies operating in this space .

Abbot offers a range of devices to improve diabetic patients’ lives and wellbeing. Last year, its Freestyle Libre system became available on prescription across England, Wales, Northern Ireland and Scotland, a device which Neil Harris, general manager of Abbott’s UK diabetes care business, said offers “life-changing improvements for people with diabetes intensively using insulin.”

The reason for Ireland’s successful medtech industry can be put down to a range of factors. According to IDA Ireland’s head of medtech, Rachel Shelly, the industry has been “underpinned by the strong skills based and access to talent; technical competency; and Design for Manufacture capability. As a result, Ireland is the largest medtech employer per capita across Europe.”

What can’t be ignored are the financial incentives offered to companies conducting R&D throughout Ireland. The 25% R&D tax credit makes Ireland attractive to medtech companies, which are largely dependent upon innovation and pushing boundaries

of science and technology. Also, Ireland’s corporate tax rate of 12.5% is one of the lowest in the OECD and the country also offers incentives for companies carrying out academic collaborations.

Ireland shows no signs that its medtech market will slow down and the next decade “will see continuing transformation within the industry, with digital disruption and transformational technologies impacting manufacturing operations,” states Shelly.

And according to Creganna’s Jeff Stanton, the very fundamentals of Ireland’s medtech industry are what helps drive the sector forward.

“Innovation, investment in R&D and continued expansion of manufacturing capability continues apace, enabled by a talent pool with deep industry and global experience. The industry fundamentals in Ireland pave the way for continued growth of the sector into the future.”

Northern Ireland’s medtech market isn’t as established as the Republic of Ireland’s but it does show promising signs of growth.

Ulster University is one of the region’s major hubs for medtech and a recent €7 million laboratory will see it offering equipment and expertise for companies developing prototypes within the biomedical sector.

The University’s €8.2 million Eastern Corridor Medical Engineering Centre (ECME) was launched earlier this year to develop smart wearable technologies for cardiovascular patients. The centre of research has partners in Republic of Ireland and Scotland, highlighting the cross collaboration that is going on across the UK and Ireland .

Indeed, Northern Ireland-based company Neurovalens – which has developed a fat burning wearable – is a medtech success story, raising over $1.5 million in funding from a goal of $50,000 .

THE IRELAND INITIATIVE Initiatives throughout Ireland are aimed at helping companies advance their technologies and now might more than ever be the best time to be a medtech start-up. The Irish government has just announced a €500 million Disruptive Technologies Fund that aims to help companies develop and commercialise their innovations.

Indeed the fund recognises the latest technologies that are beginning to change how industries operate and the government has set out a specific focus on things like augmented and virtual reality, health and wellbeing, advanced and smart manufacturing and artificial intelligence.

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https://www.idaireland.com/doing-business-here/industry-sectors/medical-technology

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https://www.rte.ie/news/2015/1208/751977-science-innovation-2020/

³ https://medtechengine.com/article/irelands-booming-medtech-scene/ ⁹ https://www.ibec.ie/IBEC/Press/PressPublicationsdoclib3.nsf/vPages/Newsroom~4,000jobs-to-be-added-by-2020---irish-medtech-association-04-05-2017/$file/ Irish+Medtech+Future+skills+needs+analysis+to+2020+report.pdf 10

http://www.thejournal.ie/tech-jobs-cork-limerick-galway-2-2-3867626-Feb2018/

https://www.irishtimes.com/news/education/employment-rates-forgraduates-return-to-boom-time-levels-1.3360612

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https://www.diabetes.ie/about-us/diabetes-in-ireland/

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https://www.med-technews.com/news/ulster-university-opens-82m-centre-to-develop-smart-cardio-wearables/

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http://digitalhealthage.com/fat-burning-wearable-surpasses-1-5m-funding/

https://www.per.gov.ie/en/project-ireland-2040-government-launches-four-funds-forrural-development-urban-regeneration-climate-action-innovation-totalling-e4-billion/ 14

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WEARABLES

Could wearables be the answer to an ageing population?

NEIL OLIVER, ACCUTRONICS, LOOKS AT HOW WEARABLES COULD HELP MEDICAL SERVICES MANAGE THE LONG-TERM HEALTH CONDITIONS THAT AN AGEING POPULATION BRINGS

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he World Health Organisation (WHO) predicts that by 2050, the worldwide population over 60 will have doubled to reach two billion people. With most age-related illnesses beginning at the age of 50, it’s clear that this will have an impact on the world’s medical services.

The growth in wearable devices and the ageing population may seem like two disconnected trends, but what if they were connected?

Wearable technology is set to be worth $34 billion by 2020, according to research by CCS Insight, so there is clearly investment in the market.

When you think of medical wearable devices, you may think of steptracking devices, geared towards the young and active, but you may not think of smoking cessation patches or a device to monitor the breathing of sleep apnoea sufferers. In fact, a study by the Journal of the American Medical Association showed that few senior citizens were using digital health technology, despite high ownership of mobile phones and computers.

Therefore, there seems to be a gap in the market for original equipment manufacturers (OEMs) to create wearable devices to track long term health conditions. However, they must consider what is powering these devices, so that they can function correctly.

As an experienced battery manufacturer, we often find that for many devices, medical included, OEMs come to us for advice far too late in the design process. They will have a space for us to fill, but there is not always adequate room to fit a battery that delivers the required energy density and runtime. Especially in wearable devices, where space is at a premium, OEMs must consider what is powering their device early on in the process.

device. For example, consumers are often tempted to purchase the cheapest version of AA batteries, which will not last as long as a higher quality battery. While this may be acceptable for a child’s toy, it is not reliable enough for a medical device.

Security concerns are also a problem with a removable battery.

With the prevalence of counterfeit batteries on the market, that the end user may easily purchase online, OEMs should incorporate algorithmic security to protect the end user of the medical device.

Accutronics offers this function to protect the end users of the medical device. When a new battery is inserted into the device, if it fails to solve the same calculation as the device, the device will flag it as an inauthentic battery, indicating the danger to the user. It will then either display a pop up message or shut down the device, depending on the preference of the OEM. If the OEM decides that a rechargeable battery is the best option for the device and the end user, they must consider how long they expect the battery to last. Previous wearable medical devices have failed because OEMs fail to undertake adequate market research and the consumer uses the product differently than was intended.

For example, the device may use more power than expected when not actively being used.

Rechargeable devices used for medical purposes must also have accurate fuel gauging. If the battery is inaccurate, suddenly drops or jumps between charge levels, this is unacceptable for a device that is used to monitor vitals. Accutronics’ CMX series batteries use an impedance tracking algorithm to predict remaining capacity, which is displayed in increments on a visual state of charge indicator.

Before creating a wearable medical device, OEMs must conduct detailed research in order to determine the usage profile for the battery. They must choose between rechargeable and nonrechargeable batteries, and removable and non-removable batteries, depending on what the best option is for the end user.

Wearable medical devices have the potential to revolutionise healthcare, especially in the context of the ageing population. Not only will doctors be able to monitor daily changes in a person’s health and can alert them when vitals reach dangerous levels, a well-designed device will also allow the elderly to become advocates for their own healthcare, monitoring changes themselves.

For example, an elderly patient with little awareness of technology may be best equipped with a non-rechargeable device with a removable battery. This means that the medical practitioner can be responsible for replacing the battery for the wearable device, rather than them having problems with charging the device.

Similarly, if a removable battery is used,patients may be given the opportunity to purchase their own batteries, which may not be the best option for a medical

However, to do this, the batteries that power the devices must be well suited to the device itself, the end user and their needs. Rather than considering the battery as an afterthought in the process, OEMs should remember that by including a battery manufacturer early on in the process, they will be able to optimise the design to make it as lightweight, portable and well adapted to the end user as possible.

WEARABLE MEDICAL DEVICES HAVE THE POTENTIAL TO REVOLUTIONISE HEALTHCARE, ESPECIALLY IN THE CONTEXT OF THE AGEING POPULATION

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3D PRINTING

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he ability to quickly 3D print high quality parts that require no post-processing has proven instrumental in cutting our iterations and directly reducing our product development cycle. In fact, since introducing Stratasys 3D printing, we have slashed our prototyping costs by 75% and accelerated our development time by 50%,” says Cesare Tanassi, managing director at Nidek Technologies.

Faced with high costs and lengthy lead-times associated with traditional prototyping, Nidek Technologies required an alternative prototyping solution to overcome these barriers, while maintaining the quality and functionality of its devices for clinical trials. With the integration of a Stratasys Objet500 Connex3 3D printer, the division has optimised its prototyping process, replacing metal component prototypes with more complex, high-performance 3D printed polymer parts, while producing intricate geometries previously unattainable.

BENEFITS/VALUE: • Integration of the Stratasys printer throughout its design process, allows the R&D division to overcome time and cost barriers of traditional prototyping methods • The abbility to combine specific mechanical characteristics of 3D printing materials to produce parts that match the performance of metal counterparts

worker

As a result, Nidek Technologies can develop functional prototypes of its vision diagnostic systems 75% cheaper and enter these into clinical trials 50% faster.

Nidek Corporation was founded in 1971, Japan, as a medical diagnostic and surgical eye equipment. The company has since established itself as a global producer of ophthalmology products.

Located in Padova, Italy, Nidek Technologies specialises in the development of high-technology diagnostic systems. With all of its products having direct contact with patients, it’s crucial that the division can develop fully-functional prototypes that precisely replicate the final product. This enables a comprehensive evaluation of the fit, form and function of new devices before investing in expensive clinical trials and moving to final production. As this process often proved costly in terms of lead-time and capital the company turned to 3D printing in a bid to optimise its prototyping process.

ACCELERATING TIME-TO-MARKET WITH 3D PRINTING This was exemplified in a recent project which saw Nidek Technologies develop a working Gonioscope, a device designed to observe the space between the iris and cornea. Typically, the R&D team would create the prototypes using traditional manufacturing. This would often require them to either produce expensive injection molds or use CNC machines to

• Prototyping costs reduced by 75% and development cycles accelerated by 50%, enabling rapid time-to-market • Precision printing enables creation of intricate geometries previously unattainable with traditional prototyping

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3D PRINTING

NIDEK TECHNOLOGIES ACCELERATES CLINICAL TRIAL EVALUATIONS AND SLASHES TIME-TO-MARKET OF VISION DIAGNOSTIC SYSTEMS WITH 3D PRINTING create the individual device components. This led to escalating lead-times and, should iterations be required, substantially increased prototyping costs.

“Our prototyping process has become much more streamlined since incorporating Stratasys 3D printing into our workflow,” said Tanassi.

he explained. “In the case of the Gonioscope, the quality and accuracy of the 3D printed components to withstand rigorous use in clinical settings were critical to accelerating the clinical trial. In fact, this saw the device pass a year-long clinical trial where eight global medical centers examined it.”

“The technology enables us to develop complex parts with intricate geometries on-demand. The ability to validate designs early in the product development cycle helps us eliminate costly iterations during manufacturing, as well significantly reducing our time-to-market compared to traditional prototyping methods.”

REPLACING METAL PARTS WITH PHOTOPOLYMERS Beyond the Gonioscope, the benefits of 3D printing are impacting other products. According to Federico Carraro, mechanical division manager at Nidek Technologies, this is particularly the case when developing the company’s micro perimeter, a device used to determine the level of light perceived by specific areas of the retina.

USING 3D PRINTED DEVICES IN CLINICAL TRIALS According to Tanassi, waiting for prototype parts to conduct clinical evaluations created costly delays.

“Previously we were constrained by the time restrictions associated with traditional prototyping.

3D printing overcomes these bottlenecks and permits us to quickly enter our devices into clinical trials. As you can imagine, fully verifying our products is crucial to ensuring that premium quality is maintained,”

“Previously we used metal fabrication for this device that took around two months to create. This method dramatically delayed our prototyping cycle and the speed at which we could validate designs before entering our prototypes into clinical trial validation,” explains Carraro. “With our Stratasys printer, we can combine a range of 3D printed materials with contrasting mechanical characteristics. This allows us to accurately emulate final parts, including threads, seals, rubber and transparent components. In this case, we achieved the same functional result within 24 hours by replacing metal parts with robust 3D printed components.”

Tanassi added: “In the case of the Gonioscope, using the tough flexibility and snap-fit characteristic of the Stratasys Rigur 3D printing material, we could replace several aluminum parts with a single 3D printed component.

The ability to quickly 3D print high quality parts that require no postprocessing has proven instrumental in cutting our iterations and directly reducing our product development cycle. In fact, since introducing 3D printing, we have slashed our prototyping costs by 75% and accelerated our development time by 50%.”

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The Event for

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Whatever your mission, find your insights, intelligence and inspiration at TCT Show.

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SHOW

REGENERATIVE MEDICINE

Bone regeneration breakthrough offers great potential RESEARCHERS FROM THE HONG KONG POLYTECHNIC UNIVERSITY (POLYU) HAVE DESIGNED A SELF-FITTING BONE SCAFFOLD BY COMBINING A SHAPE MEMORY POLYURETHANE FOAM AND HYDROXYAPATITE (THE MAIN MINERAL COMPONENT OF BONE TISSUE)

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he scaffold can be safely and conveniently implanted into bone defects and induce bone regeneration, enhancing the recovery of bone injuries and fractures. To date, no bone scaffold in the commercial market possesses such shape memory self-fitting effect, says PolyU. Despite the regenerative capacity of bone, for large bone defects due to bone tumour resections or severe fractures, bone grafting surgeries (autografts or allografts) are always required for orchestrating bone regeneration. With bone fracture becoming a rising worldwide health concern, especially for ageing societies, how to improve grafting process or induce bone regeneration effectively, helping relieve suffering and reduce society’s medical expenses, have become a rising challenge for scientists. Taking hip fractures from osteoporosis as an example, a latest study projected that the number of annual new cases in Hong Kong, of 9,590 this year, will be tripled by 2050; Malaysia and Singapore will reach 3.5 times during the same period.

One promising field explored by tissue engineering scientists is to develop a bone scaffold which can act as template for speedy tissue regeneration, and can be used in minimally invasive operation to reduce hospitalisation and infection risk. The novel scaffold developed by the team of PolyU researchers, led by Professor Hu Jinlian (Principal Investigator) and Dr Xie Ruiqi from the Institute of Textiles and Clothing, and Dr Guo Xia from the Department of Rehabilitation Sciences, has offered promising breakthrough. The team has close collaboration with Sichuan University in cell culture and animal modelling for the research.

The novel scaffold made of shape memory polyurethane foam and hydroxyapatite (HA) nano-particles, is characterised by its self-fitting effect. As a shape memory material, the scaffold can be compacted at 0°C, implanted with compact shape at room temperature, and recovered to its original shape completely at 40°C. The scaffold can therefore, fill up the irregular bone defects perfectly. The transitional temperatures, with range close to human body’s physiological temperatures, also enhance the feasibility of using the scaffold in minimally invasive surgery.

The self-fitting scaffold possesses a highly porous structure with interconnected pores to allow cells migration and formation of new tissues. The average pore size of the scaffold is 670 μm (diameter of a human hair is around 100 μm), which is close to that of trabecular bone (the inner layer of bone) and therefore mimics the actual in vivo microenvironment. The optimal structure of the scaffold is around 60% of space voids.

The mechanical strength of the scaffold can neither be too low (may cause deformation or crash) nor too high (may reduce the density of surrounding bone tissue). The compressive strength of the PolyU developed self-fitting scaffold is designed at 13.6MPa (Megapascal), which is comparable to that of trabecular bone. Laboratory tests also show that the self-fitting scaffold is biocompatible and has no cytotoxicity.

ANIMAL STUDY ON BONE REGENERATION “Our research team further examined the performance of the self-fitting scaffold in facilitating bone regeneration through a rabbit femoral defect study. The results show that our scaffold has overcome the disadvantages of traditional polymer scaffolds, and has great potential for bone regeneration,” said Professor Hu. In the animal study, 18 rabbits with a femoral bone defect in each knee, making up a total of 36 lesions, were divided into experimental group and control group.

The bone defects of the rabbits in the experimental group were implanted with self-fitting scaffolds (with original size around 5% larger than the bone defects) compacted to around 50% of their original size. After triggering with 40°C saline, the scaffolds expanded from the compacted shape to fill the defect in 60 seconds. The bone defects in the control group were left unfilled.

Twelve weeks after the surgery, the experimental group displayed faster bone tissue ingrowth in volume. There was 46% of bone ingrowth, or the proportion of total defects being repaired. On the contrary, the control group had only 24%.

The self-fitting scaffold has been proved inducing the formation of osteoblasts and blood vessels, which are responsible for the synthesis of bone tissue. In the experimental group, 12 weeks after the surgery, the number of neovascular buds grew on the scaffolds was 4 times of that in the control group. Moreover, 5% of bone surface was covered by osteoblasts in the experimental group whereas the control group recorded almost no osteoblast.

In conclusion, the novel shape memory scaffold developed

by PolyU has the advantages of: being implanted via minimally invasive operation; self-adaption and self-fitting; optimal structure for bone remodeling; full biocompatibility and optimal mechanical properties.

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MED-TECH INNOVATION EXPO

15 - 16 MAY 2019 NEC | BIRMINGHAM | UK medtech | digital healthtech | medical plastics | manufacturing software | inspection and metrology | regulation | design early stage innovations | pharmaceutical manufacturing

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ANTIMICROBIALS

CLEAN ON ME

Andrew Gaillard, Trelleborg Sealing Solutions, explains how tests prove that the immersion method of production of implantable devices is effective

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ealthcare-associated infections (HAI) are a major, yet often preventable threat to patient safety and they can have a significant impact on the survival rate of patients who undergo procedures and treatments. In particular, catheterassociated infections are difficult to prevent, even when products are made of silicone, due to their inherent positioning both inside and outside of the body.

Though silicone is biocompatible and bio-stabile, it is not immune to bacterial colonisation. Three techniques exist that can reduce this colonisation. These are coating with active pharmaceutical ingredients (APIs), the addition of API to raw silicone, and the impregnation of vulcanised silicone with API through immersion.

Coatings of API are applied to silicone catheters by spraying or dipping.

Though probably the most cost-effective method of treatment, achieving good uniformity and long life is challenging.

Cracking or peeling of coatings may occur and in some cases, it can be hard to apply a coating to the inner lumen surface of a catheter.

However, compatibility of the API with the silicone grade needs to be confirmed as some API can inhibit or even poison the cure system of certain silicones. Also, particular drugs are not stable at elevated temperatures.

In these applications, silicones that can be vulcanised at relatively low temperatures may be utilised, but this limits the type of API that can be used.

The third and newest method to reduce bacteria colonisation is the impregnation method. The vast majority of silicone medical components are manufactured from raw material formulations containing polydimethylsiloxane (PDMS) polymers reinforced with amorphous noncrystalline silica. Vulcanised PDMS elastomers can be readily swollen by immersion in various organic solvents.

Using this characteristic, vulcanised silicone can be immersed in a solution containing API to impregnate the vulcanised silicone with active drugs.

The advantage of the impregnation method of vulcanised silicone with API is that the API cannot interfere with the cure chemistry of the silicone and that the API is uniformly impregnated on the surface of the inner lumen.

The second and well-proven method used to prevent bacterial buildup involves the adding of antibiotic API, such as chlorhexidine, gentamycin, xifaxin, and doxycycline in powder form to silicone raw materials using various types of mixing equipment.

After homogenization, the silicone drug mixtures can be formed into desired shapes and vulcanised using various fabrication processes including molding and extrusion.

Immersion is usually conducted at room temperature, thereby eliminating concerns regarding the thermal degradation of the API, expanding the types of APIs that can be used.

In addition, dissolved drugs are impregnated within the silicone elastomer as discrete molecules.

Concerns and costs associated with specifying and maintaining a particular size and distribution of particles are minimised.

The key advantage of this method is that the API is effectively and consistently present within the silicone.

Immersion experiments have conclusively demonstrated the mass transfer of two antibiotics: Clindamycin

THIS SHOWS TEST RESULTS OF THE IMPACT OF DRUG CONTENT OF SILICONE TUBES IMPREGNATED WITH API ON THE GRAM-POSITIVE COCCAL BACTERIUM, STAPHYLOCOCCUS AUREUS

Hydrochloride (CLIN) and Rifampicin (RIF) from chloroform solutions to silicone tubing. Following on from these tests, a study of the Kirby-Bauer Zone of Inhibition (ZOI) assessed the impact of drug content of silicone tubes on the gram-positive coccal bacterium, Staphylococcus aureus.

The results of this study showed that drug-impregnated tubing had a powerful inhibitory effect on the growth of Staphylococcus aureus and clear zones of inhibition were seen surrounding test articles. As expected, the higher the drug concentration, the larger the Zone of Inhibition (ZOI).

Though still in the early stages of usage, the impregnation method looks positive, potentially allowing the expansion of the drug types that can be delivered via silicone implantable devices.

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ANTIMICROBIALS

Keep it clean LU RAHMAN LOOKS AT SOME OF THE LATEST ANTIMICROBIAL OFFERINGS FOR MEDICAL DEVICE MANUFACTURE

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helsea Whyte in the New Scientist described a study carried out by the University of Hong Kong where volunteers used the subway for 30 minutes and then swabbed their hands. Upon analysis of the swabs, “the majority of microbes they picked up were common skin bacteria, and the most abundant non-bacterial organisms were yeasts. In the morning rush hour, 140 species were detected, but by evening, many of those were no longer detectable and the populations of just 48 species had expanded to cover the entire system.”

The article also described how “the team also swabbed train surfaces, but they didn’t find much microbial DNA – perhaps because of the antibacterial coating that is applied to the surfaces of the Hong Kong subway”.

Antimicrobial products make a difference. Infection control is big business. As the pharma sector seeks ways to tackle antimicrobial resistance (AMR), the medical device sector is developing ways to curb the spread of harmful bacteria in the healthcare environment. The opportunities are evident.

According to Marketsandmarkets, which projects the antimicrobial coatings market to reach $4.19 billion by 2021: “Healthcare is the key application of antimicrobial plastic... It is the largest application in the antimicrobial plastic market and accounts for more than one-third share of the market. The AsiaPacific region dominated the market for health care application of antimicrobial plastic, followed by North America and Europe.”

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ANTIMICROBIALS

Ionic silver is successful at killing bacteria and preventing colonisation.

Marketsandmarkets lists leading players in the market as including Bayer MaterialScience, The Dow Chemical Company, Clariant, Lonza Group, Parx Plastic, King Plastic Corporation, Biocote, Milliken Chemical and PolyOne Corporation.

A specialist in polymer solutions for healthcare markets, Foster recently introduced Combat antimicrobial masterbatches for blending with medical device polymers. Components made with these antimicrobial polymer blends kill bacteria that lead to infections, including methicillin-resistant staphylococcus aureus (MRSA) and carbapenem-resistant enterobacteriaceae (CRE).

Foster says that according to a survey by the Center for Disease Control (CDC), 4% of inpatients in US acute care hospitals contract at least one healthcare associated infection. Device associated infections accounted for one in every four infections.

In-dwelling devices, such as central venous catheters, are particularly susceptible to bacteria colonisation which can enter the bloodstream.

Ionic silver is successful at killing bacteria and preventing colonisation. Additives based on this chemistry are commonly melt blended directly into medical polymers for the manufacture on antimicrobial device components. However, evaluation of multiple custom compound formulations can be costly.

“Combat master batches are available in quantities as low as two pounds to minimise costs for initial evaluations,” said Larry Johnson, executive vice president for Foster Corporation. “With let-down percentages of 2-10%, depending on the polymer and applications, these small order quantities allow engineers to test several antimicrobial formulations from a single order quantity.”

Parx Plastics sees an important role for its technology in the quest to tackle AMR. Its antimicrobial technology for plastics and polymers is derived from bio-mimicry, a patented biocompatible technology inspired by nature. The technology creates an intrinsic immune system in plastics that makes the surface resistant to biofilm formation and bacteria growth.

With a focus on infection prevention Parx Plastics believes it wise to consider the antimicrobial technology to use. Roughly all of the technologies today, it says, rely on a migration principle. They have some active (and often toxic) substance migrating from the surface to act against bacteria. However, these uncontrollable technologies contribute to AMR as their functional substances can end up anywhere in the environment of the product creating more places for only the resistant bacteria to survive and proliferate. Taking AMR seriously, says Parx, means applying the technology only there where you want to use its benefits.

“This is really where our technology stands out,” explains Michael van der Jagt, CEO of Parx Plastics. “First of all our technology uses a body’s own element and on top of that our technology knows no migration, the performance is inert and intrinsic to the material surface. That means you have a targeted performance only on the surface where you want it and it does not end up elsewhere.”

Van der Jagt envisions this technology will be of particular use in high-infection risk applications with permanent implants such as in the orthopaedic field.

WWW.MEDICALPLASTICSNEWS.COM

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International exhibition and conference on the next generation of manufacturing technologies Frankfurt, Germany, 13 – 16 November 2018 formnext.com

Discover the future of manufacturing at formnext!

Is your head full of ingenious ideas? Are you looking for innovative partners to realize them using additive manufacturing and the latest manufacturing technologies? We provide the ideal platform.

Where ideas take shape.

Offical event hashtag #formnext

THERMOFORMING

Shaping up nicely JASON MIDDLETON, RAY PRODUCTS EXAMINES THERMOFORMING AND THE FUTURE OF MEDICAL DEVICE MANUFACTURING

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recision and safety are paramount in every facet of the medical industry; medical device manufacturers are always looking for processes that help them produce safe, durable and effective products at a reasonable cost – and thermoforming is at the top of the list.

THERMOFORMING 101 At its simplest, thermoforming is the process of heating a sheet of plastic until it becomes pliable, then using an aluminum temperature-controlled male or female mold to shape the material into a three-dimensional part.

There are two different methods of thermoforming: vacuum forming and pressure forming. In vacuum forming, the plastic sheet is stretched over a male mould and then the air inside the mould is vacuumed out, with the plastic retaining the shape of the mould.

ONE OF THE BENEFITS OF THERMOFORMED PLASTIC IS ITS ABILITY TO CONTRIBUTE TO THE HEALTH AND SAFETY OF HEALTHCARE ENVIRONMENTS, SAYS RAY PRODUCTS’ JASON MIDDLETON

The pressure-forming process adds 80–100 psi of air pressure to push the plastic sheet into the female cavity mold surface, providing very high detail and cosmetics on the outside surfaces of the moulded part.

In both methods of thermoforming, the plastic is allowed to cool after being moulded, which allows for a finished part with zero residual stress. Then, any excess plastic is removed with a six-axis, fully robotic trimming machine.

After trimming, further customizations can be incorporated – from aesthetic touches like silk screening and EMI / RFI shielding to the addition of functional hinges, handles and other hardware.

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THERMOFORMING

Thermoforming is an excellent method for manufacturing production quantities from the low hundreds to the high thousands; and the process ensures that no matter the quantity, the quality (and specifications) are the same in the first piece as in the last.

A CUT ABOVE So what does thermoformed plastic offer that other plastic manufacturing processes, like injection moulding, don’t?

For one, thermoforming can produce very large pieces like MRI or CT enclosures, storage bins or other equipment like chairs and hospital beds. And while injection moulding is excellent for small complex parts with very high volumes, similar details can often be achieved with thermoforming.

Thermoforming also has lower tooling costs and a faster turnaround than injection moulding, plus equal (or sometimes better) aesthetics – unlike some injection moulded parts, thermoformed plastic doesn’t need to be painted, although it certainly can be. That said, there are some scenarios in which injection moulding is the best option.

When compared with other materials, like sheet metal or fibreglass, thermoformed plastic outperforms the competition on nearly every level.

Fibreglass, which can be very labor-intensive and expensive, is up to 35% heavier than thermoformed plastic, is not recyclable and is more susceptible to damage from UV and impact.

Notably, fibreglass does not support the complex geometries and repeatability that thermoforming offers.

Sheet metal is still used in medical devices, but in many cases, thermoformed plastic is a better alternative. Sheet metal is heavier and more prone to scratching and denting. Unlike sheet metal, thermoformed plastic can be formed into complex shapes, does not amplify noise and is incredibly durable.

With a range of materials, finishes and textures, there is endless room for detailed customization in thermoforming – especially in the medical industry.

THERMOFORMING & MEDICAL DEVICES Sturdy, scratch-resistant and lightweight, thermoformed plastic is ideal for medical devices that see heavy use, like medical electronics, imaging enclosures, surgical device housings and sterile packaging.

But one of the key benefits of thermoformed plastic is its ability to contribute to the health and safety of healthcare environments.

In addition to being easy to clean, thermoformed plastic can be constructed with antimicrobialresistant properties built into the plastic, helping to increase hygiene and protect patients and health care workers.

WWW.MEDICALPLASTICSNEWS.COM

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Five highlights at Medtec China

1

The event offers over 50 debuting companies and 400 suppliers

The regulatory zone is aimed at addressing the international medical device industry in China.

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3

Seminars for high-end medical device production

Dunn Industries’, a Tekni-Plex business tubing solutions for endovascular catheters

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Gerresheimer Medical Systems’ micro injection moulding expertise to produce extremely small for medical devices

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10:2018 Covestro helps give diabetes the needle

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magine being able to treat diabetes without needles. For more than 114 million Chinese patients, it can be a reality. New research studies indicate needle-free injection is a viable therapy for diabetes and effective blood glucose control.

has the most patients with diabetes in the world.

“Our vision is to make the world a brighter place,” said Wang Xinyu, sales director for China, healthcare sector, polycarbonates business unit, Covestro.

“For patients with diabetes, that means working to find solutions that push the boundaries of what is possible. Needlefree technology can provide patients with a more comfortable, efficient injection experience and help increase medication compliance.”

QS Medical Technology, based in Beijing, has designed a needle-free injection technology for patients with diabetes.

“We are focused on developing innovative medical products to make life a little easier and more comfortable for millions of patients in China and around the world,” said Justin Zhang, founder and general manager for QS.

QS selected Makrolon Rx1805, a medical-grade polycarbonate from Covestro, for the medicine ampoules.

Makrolon medical-grade polycarbonates offer durability, processability, safety and design flexibility, which meet the stringent requirements of a variety of medical products.

“That’s why we have partnered with Covestro to produce high-quality, needle-free injectors to meet the needs of a growing number of patients with diabetes,” said Zhang. Currently, China

A

WHO GOES THERE? SENSOR DESIGNED TO DETECT DISEASE

start-up is working on a device to detect tropical diseases caused by mosquitos to help stop transmission to humans

SMK Diagnostics, a start-up from Purdue University, is developing a sensor to identify and monitor diseases spread by mosquitos, such as Zika. The start-up has developed an electrode coated with a material that has a high surface area to detect viruses in mosquitos.

The device is able to detect the RNA (ribonucleic acid) of a virus by immobilising certain biological molecules. When the DNA or RNA of a mosquito carrying a virus bind to the surface, it changes the surface resistance on the electrode and the sensor can then determine if a virus is present.

SMK Diagnostics hopes that the sensor will be able to detect tropical diseases faster and at a lower rate than current methods. It aims to place its technology in areas where disease-carrying mosquitos are particularly prevalent.

Check out...

The latest issue of Med-Tech Innovation News

O

ffering the latest developments in the medtech sector for UK and Ireland, Med-Tech Innovation News brings you uupdates from its upcoming exhibition in May next year (relocated to the NEC, Birmingham, 15-16 May) as well as in-depth intelligence on the medtech sector in UK and Ireland.

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Brilliant performance | ENGEL medical

us at t i s i V 2 018 a m Fa k u l A 5 Hal 52 0 4 h t o Bo ENGEL medical Fully-electric machines impress with great performance. The ENGEL e-motion medical series combines best-of-class performance with maximum cleanliness.

Optimised for clean room applications, the machine has an encapsulated barrel to minimize particle and heat load, along with encapsulated injection unit drives and an oil return unit on the toggle lever as standard features. The ENGEL e-motion medical is available as a continuous series with up to 500 tonnes clamping force.

Clean and precise. With ENGEL medical. Because it is about life.

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