MPN EU Issue 33

MEDICAL PLASTICS news

ELECTRIFYING POWER

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meets passion

Medical plastics at the K Show Extrusion 3D printing

Netstal excites WITH K SHOW LAUNCH ISSUE 32

Sept-Oct 2016

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CONTENTS Sept-Oct 2016, Issue 32

Regulars 5 Comment Lu Rahman reveals some exciting news about the future of MPN 7 News analysis The changing relationship between medtech and healthcare 8 Digital spy 11 News focus Extraordinary steerable catheter and how polymers could prevent chronic inflammation in lupus patients 16 News focus What K 2016 has in store for the medical sector

22 Cover story Netstal explains how the company is helping tackle the growing problem of counterfeiting 46 Medtech at the movies

Features 25 Q&A Rudi Gall, Raumedic, outlines market trends and challenges in the tubing sector 27 East meets west Lu Rahman looks at where the emerging trends are in the medtech sector 30 Test case Caitlyn Scaggs, Polymer Solutions, outlines the key aspects for independent testing lab

33 On the move Tim Jennings, Custom Case Group, explains how the trend for mobile medicine in the US is affecting portable medical device R&D 34 Sealed bids Sean Egan, Nelipak Healthcare Packaging, discusses best practices for healthcare packaging seal integrity 37 It’s a wrap Dwain Tarmey, Vistamed discusses the jacketing of hypotubes and coils for the medical device industry 41 The printed word Stratasys and Bristol University look at 3D printing applications

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At Phillips-Medisize We’re All About Process

We know process is the absolute key to assuring that we deliver upon our customers’ expectations, the first time and every time.

That’s why our people are all about process. In fact, our process requirements apply not only to manufacturing and quality SOPs, but also to our customer facing operations such as Program Management and Design and Development engagements, ensuring our customers benefit from a repeatable and scalable model.

So, when you work with Phillips-Medisize, you can be certain we’ll exceed your highest expectations the first time and every time.

Contact Phillips-Medisize: phillipsmedisize.com / eu_sales@phillipsmedisize.com

CREDITS

EDITOR’S

group editor | lu rahman

comment

deputy group editor | dave gray advertising | gaurav avasthi art | sam hamlyn publisher | duncan wood

Medical Plastics News is available on free subscription to readers qualifying under the publisher’s terms of control.

Those outside the criteria may subscribe at the following annual rates: UK: £80 Europe and rest of the world: £115 subscription enquiries to subscriptions@rapidnews.com

Medical Plastics News is published by: Rapid Life Sciences Ltd, Carlton House, Sandpiper Way, Chester Business Park, Chester, CH4 9QE T: +44(0)1244 680222 F: +44(0)1244 671074 © 2016 Rapid Life Sciences Ltd While every attempt has been made to ensure that the information contained within this publication is accurate the publisher accepts no liability for information published in error, or for views expressed. All rights for Medical Plastics News are reserved.

Reproduction in whole or in part without prior written permission from the publisher is strictly prohibited.

BPA Worldwide Membership

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MPN TAKES ON THE US

he medical plastics market is innovative, exciting and of course, global. At MPN we watch closely the developments taking place on the world stage to keep you informed of the latest trends and advances. Presenting the sector’s latest news, thoughts and innovative practices keeps you at the forefront of an industry that’s crucial to advancing healthcare internationally.

With that in mind we have some very exciting news aimed at helping you expand your reach and increase your knowledge of global markets – the launch of a dedicated North American Medical Plastics News.

The current MPN has always maintained a strong connection with its US audience and we’ve noticed that over recent years, this section of our readership is growing making the time right to offer a dedicated publication for this forward-looking region.

The medical plastics sector is significant. Some estimates place its value reaching $7.54bn by 2022.

Within this, North America is said to hold a 43% share of the overall global market. The prominence of the market is evident. Last year Christoph Lhota, vice president for Engel’s medical division, told MPN that he was expecting to see the market for plastic products for medical technologies grow slightly in 2016. He also said: “We also see potential in Europe but it is strongest in North America”.

We wouldn’t be doing our job if we didn’t keep on top of these trends and failed to reflect their importance to our audience – hence MPN North America. We’re very excited here and we hope you share that enthusiasm as we plan our first issue which will be with you early next year. Please get in touch if you’d like to contribute or just find out more about the new addition to the MPN portfolio.

“

Our readership is growing making the time right to offer a dedicated publication for this forwardlooking region.

Just like the original mag, our new US-focussed title will provide a multiplatform hub for anyone working or targeting this sector. It will be a place to discuss, promote and learn – just like its UK counterpart. And with the same quality of readers – senior decision-makers from some of the world’s most influential medical devices OEMS, it will provide increased opportunities for both readers and advertisers to reach and communicate with the wider medical device market.

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

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Let’s make SOMETHING NEW together.

We’re relentless about bringing new ideas to every aspect of our operations, from product design and development to tooling and injection molding to assembly and logistics. It’s how we’ve developed innovative, cost-effective solutions for leading brands for more than 30 years—and taken them from our advanced manufacturing facilities on three continents into hospitals, drug stores, doctors’ offices and patients’ homes. It’s innovation applied, around the world.

Technimark recently acquired Ci Medical, creating an ideal marriage of innovation and experience. With the launch of Technimark Healthcare, we’re focused on delivering new technologies, solutions and manufacturing options for the global healthcare market. technimark.com

NEWS ANALYSIS

The changing relationship BETWEEN MEDICAL DEVICES AND HEALTHCARE

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ccording to a new report by PwC Health Research Institute the relationship between healthcare and the Lu Rahman looks medical device sector at PwC Health is changing. Beyond the Research Institute’s device: From producer to solver, outlines report and highlights problem how the business model the changing of the device sector is relationship between changing.

healthcare and the device sector

Many medical device technology manufacturers are forging deals with healthcare providers. PwC’s Health Research Institute looked at the top ten medical device companies according to 2014 revenues. It found that:  Five out of ten offered customised solutions that are independent of their product offerings and  Seven out of ten have carried out changes within their organisation to reflect the shift towards servicebased offerings  Ten out of ten are providing training and educational resources According to the report the industry is changing in accordance with consumer desires who are looking for increasingly convenient and userfriendly care. It says: “The medtech industry is using digital tools and services to pair these new consumer expectations with clinicians’ needs to monitor health outcomes, analyse results of medical interventions and share that information quickly and

efficiently with other providers, other devices and patients.”

One company highlighted is Stryker Performance Solutions.

The company offers digital health solution JointCoach, which connects joint replacement patients with their healthcare teams. It helps providers manage care while giving patients information on surgery preparation and rehabilitation.

products such as apps, at-home diagnostic tests and wearable sensors for remote monitoring.

The report also reveals the importance of the cloud in the medtech sector with manufacturers “using the cloud to boost accessibility and to improve the accuracy of readings by combining machine learning with physician expertise”.

According to PwC Health Research Institute, ‘clinicians and consumers are demanding more from the devices and technology they use, spurring innovation by manufacturers. In parallel, physicians are looking to new technology to improve workflow as well as patient satisfaction and outcomes.

It uses GE Healthcare’s cloud platform – which gives customers access to images and tests – as an example. “Doctors want to spend more time with patients, not more time doing data entry,” Evren Eryurek, software chief technology officer at GE Healthcare, told HRI.

 55% of physicians said they were implementing technology to improve workflow

The move towards home-based models of care has also been underlined. According to the survey two thirds of consumers are interested in receiving care in their home and “several health systems and start-ups are experimenting with home-based models and mobile technologies to better serve key population segments, such as frail and elderly patients”.

HRI says that this trend is leading to medical device companies developing

 47% said it was to increase access for patients

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 52% said it was to create better patient experience

 43% said it was it increase patient adherence Source: PwC Health Research Institute clinical survey 2015

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DIGITAL

DEVICE UPDATE

spy DIGITAL UPDATE

@UVA

3D PRINTED SKULL

helps patients breathe more easily

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r Jose Gurrola’s clinic at the University of Virginia Health System treats patients with nasal issues – anything from nosebleeds and chronic sinusitis to brain fluid leaks.

To assess the patients and determine the best course of action, Gurrola or a member of his team may perform an endoscopy – a procedure that involves taking a camera with a long scope on the end and inserting it into a patient’s nasal cavity.

It’s seldom a welcomed prospect. “Most patients are not used to having something in their nose, so they may be very nervous,” Gurrola said.

Similarly, new doctors may have some uneasiness before performing the procedure on a patient for the first time. But a recent development at UVA is creating new opportunities that bolster the confidence of both patients and residents in the otolaryngology department.

Gurrola, a nose specialist, along with Dr Robert Reed, an otolaryngology resident, and Dwight Dart, a design lab engineer at the UVA School of Engineering and Applied Science’s rapid prototyping 3D printing lab, have created 3D-printed skulls to use

as models for rhinological surgical simulation using a combination of software and hardware.

To create the models, a patient’s CT or MRI scans are converted to 3D printable files, which are then printed on a 3D printer. “The models allow students, residents and doctors to see, feel and understand dimensions of real human geometry,” Dart said.

According to Gurrola, the benefits of the 3D models are plentiful; they are relatively cheap to produce, reusable and readily accessible to trainees. “3D printing is going to revolutionise medicine,” Dart said.

The model skulls “are available to students or doctors in affiliated programs, such as neurosurgery, whenever they want it,” Gurrola said. “This allows our UVA trainees to gain significant endoscopy experience early on and throughout their career.”

Reed believes that the 3D models can transform surgical training and become a beneficial mode of practice.

Credit: Kaylyn Christopher, University of Virginia & UVA Office of University Communications/UVA Today

New anti-chocking device: YOU CAN USE ON YOURSELF

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ifeVac is a new single suction anti-choking device with a patented one way valve, so when applied no air/force can be pushed through the mask, but when pulled creates three times more pressure than the world’s highest recorded cough with no risk to the casualty.

When applying LifeVac simply place the mask over the mouth and nose, hold in place with one hand as the seal is critical for the vacuum, then with the other hand on the handle push down and pull up quickly.

MATERIAL UPDATE

FOSTER’S TPU AIMS TO IMPROVE EXTRUSION PROCESSING CONTROL

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oster Corporation, is now offering thermoplastic urethanes (TPU) with PureEase technology for improved extrusion processing control. This proprietary additive system was developed to help maintain consistent processing parameters of validated TPU based polymers and compounds.

Consistent processing parameters can mean tighter ID/OD tubing tolerances especially in small tubes.

“Many medical devices require validated manufacturing processes for components such as tubes and films. This can be challenging for components made from TPU’s due to process variability,” said Lawrence Acquarulo, CEO of Foster Corporation.

“PureEase technology improves process consistency and reduces dimensional variation of finished components.”

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LifeVac can be self-applied and can be used when the casualty is unconscious or conscious. It is ideal for people with disabilities or wheelchair bound.

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PureEase technology is available in custom TPU based compound formulations used in radiopaque filled tubing applications commonly used in central venous catheter (CVC) tubing. It can also be beneficial in unfilled TPU polymers as well, in applications where tight tolerances are necessary such as wound care films.

DIGITAL SPY

DIGITAL NEWS

YOU NEED THIS

if you offer an app with your medical device With smartphones becoming an integral part of the healthcare system, apps increasingly being used for diagnosis purposes and medical device manufacturers adding value to their products with dedicated apps, the industry regularly faces the question – when does an app become a medical device?

The app market has exploded over the last few years and some estimates say that by 2017 the sector will generate $77 billion of revenue.

With this in mind the Medicines and Healthcare products Regulatory Agency (MHRA) has issued updated guidance to help identify the health apps which are medical devices and make sure they comply with regulations and are acceptably safe.

The guidance is great for app users; it’s also ideal for software and app developers to identify whether their product is a medical device. It will aid developers in navigating the regulatory system so that they are aware what procedures they need to have in place to get a CE mark which indicates acceptable safety standards and performance, and what their reporting responsibilities are when things change or go wrong.

talking

POINT

I FEEL FINE:

Fake hands feel for real Researchers at Stanford are inventing materials for touchsensitive prosthetics

DIGITAL SPY

Tweets with character MPN allows itself a few more than 140 characters to elaborate on one of our most popular tweets from the past month

The tweet: “Bell of the ball: Environmentally friendly dress highlights the importance of recycling medical plastics” What’s the story?

We like to stay on trend at MPN HQ, and when it comes to fashion, we think we’re a pretty stylish crew.

So we were excited to hear news sustainable fashion designer Nancy Judd,

who’s latest collection is made from recycled medical packaging.

Nancy used Tyvek, a DuPont product that often sees application in the medical world. It has a similar appearance to paper and was used to make a striking wedding dress in Nancy’s latest work.

What is it?

Making fake hands feel. Research being carried out into material for touch-sensitive prosthetics at Zhenan Bao’s lab at Stanford could lead to prosthetic hands being able to actually feel things.

How is this possible?

It’s done by wrapping prosthetics with electronic skin that can sense pressure, heal when cut and process sensory data. If prosthetics can one day be wired to the nervous system, we are a step closer to them being able to deliver a sense of touch.

Is it really possible?

Given that the human hand has around 17,000 touch sensors, it does seem a tall order to replicate this with technology. However, according to MIT Technology Review, Zhenan Bao is hoping to alter this by rethinking electronic material. It says, “Electronic skin should be not only sensitive to pressure but also lightweight, durable, stretchy, pliable and self-healing, just like real skin. It should also be relatively inexpensive to manufacture in large sheets for wrapping around prosthetics.

Traditional electronic materials are none of these things.”

Bao has been working on this since 2010. It’s been an intricate process where she has had to create new “chemical recipes” for the electronic components, “replacing rigid materials like silicon with flexible organic molecules, polymers, and nanomaterials”.

What else could this technology do?

It’s thought that electronic skin would be beneficial for amputees or burns victims. It could help them pick up objects as well as potentially easing phantom limb pain.

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Laser Plastic Welding

Reliable, Clean, Economic LPKF’s production solutions – success through experience.

K 2016: October 19 – 26, 2016, Hall 11, Booth E04

LPKF WeldingQuipment GmbH Phone +49 (911) 669859-0 www.lpkf-laserwelding.com

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NEWS FOCUS

STEERABLE CATHETER HAILED AS

‘extraordinary’ product

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ambridge Design Partnership (CDP) has teamed up with King’s College London to develop a novel steerable catheter designed by King’s researchers. The catheter is designed to improve the treatment Innovative features mean of cardiac arrhythmia – a range the medical device can allow of conditions which can lead to corrective treatment to be stroke or heart failure that affects delivered to very specific 2 million people a year in the UK.

areas of the heart

The new steerable, micromoulded catheter enables targeted delivery of radio frequency energy to specific points in the heart tissue for corrective treatment.

Compared with traditional catheters, the new device has been designed to be quicker and easier to manoeuvre into the correct position, improving the accuracy of positioning and minimising damage to healthy tissue, which should improve success rates of the treatment.

CDP won a four-way competitive bid to further develop the device created by King’s College London, involving helix-shaped interlocking tubes that would allow improved steerability and greater compatibility for robotic control over other catheters on the market. The team at CDP refined the initial design, enabling the device to meet key regulatory and biocompatibility requirements, whilst ensuring suitability for commercial manufacture. Through CDP’s experience of developing highly technical medical devices, the team was able to miniaturise the design to allow improved space for the delivery of ablation energy

and irrigation. The new catheter design is also assembled from micro-injection moulded sections, incorporating features that enable the device to be built on an automated assembly line at reduced manufacturing cost.

Matt Brady, head of medical therapy, Cambridge Design Partnership, said: “The steerable catheter is an extraordinary product, with innovative features that enable corrective treatment to be delivered to very specific areas of the heart. By enabling greater accuracy and quicker treatment time, we believe it is possible to preserve more healthy heart tissue, and increase the success of the treatment. It’s been hugely exciting to be involved in this joint project with King’s College London and use our expertise to bring such an innovative product one step closer to commercial use.”

Professor Kawal Rhode, professor of biomedical engineering at King’s College; London, commented: “We have been delighted with the results of Cambridge Design Partnership’s work on this project. The team was chosen for the strength of their existing experience in developing catheters across both start-ups and global corporations. We were very pleased with the engineering approach and practical improvements that they managed to incorporate. They delivered fully moulded parts, and specified other components and the assembly route which fully met our aspirations for the project.”

King’s College London is now undertaking extensive lab testing of the catheter device, with clinical trials expected to be take place in two to three years.

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Bormed™ Because we care

Reliable plastic solutions for the safety of patients Borealis and Borouge are leading suppliers of innovative plastic solutions that add value for all stakeholders in the healthcare value chain – from pharmaceutical company to patient.

With more than 30 years of experience, we enable customers to meet their need for high-quality, lightweight and aesthetic products. We focus on delivering excellence by working in line with the principles of Commitment, Service and Conformance. Our portfolio of Bormed™ products is the result of our continuing dedication to your industry.

Our Bormed™ portfolio of polyolefin solutions offers superior technical performance for medical devices,

pharmaceuticals and diagnostic packaging. We guarantee the security of our supply and provide technical support tailored to the specific and stringent requirements of the market. Our service specialists cover 55 countries worldwide, so we can offer global service, while ensuring fast and reliable delivery.

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

For more information visit: www.borealisbecausewecare.com

Visit Borealis and Borouge at CPhI Worldwide in Barcelona from October 4-6 in the InnoPack hall H2, booth 2K28.

NEWS FOCUS

Polymers could prevent chronic inflammation in lupus patients

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he polymers have commonly been used in genetransfer experiments because they bind to the nucleic acid in DNA and RNA. When deployed directly in mice with lupus or an acute flu infection, the polymers Polymers that scavenge debris home in on the DNA and RNA from dying cells appear to refuse from dying cells, halting halt the cycle of chronic the damaging immune attack.

inflammation in lupus, while enhancing the body’s ability to combat flu, according to Duke Health studies in mice

“This debris left by dead cells can mistakenly signal to the body that there is an infection that warrants immune action, triggering the innate immune system,” said Bruce A Sullenger, director of the Duke Translational Research Institute. Sullenger is senior author of a study published online in the Proceedings of the National Academy of Sciences.

“By selectively targeting the source of the immune activation rather than shutting off the innate immune system downstream, these nucleic acid scavengers are able to limit pathological inflammation without compromising one’s ability to fight a viral infection,” he said.

Pathological inflammation, a major cause of illness and death around the world, is a hallmark of autoimmune diseases, including lupus and diabetes, as well as chronic conditions such as heart disease and some cancers. It also fuels the organ failure associated with severe infectious diseases such as Ebola or even flu.

Current therapies to treat pathological inflammation generally focus on quieting the overactive immune response, but in suppressing the immune system, patients are vulnerable to severe infections arising from other sources.

Intrigued by the ability of certain polymers to mop up DNA and RNA for gene transfer, Sullenger and colleagues tested the idea that these chemical compounds might also be effective targeting such nucleic acids as they arise in cell death.

“Essentially what you have in an autoimmune disease is a vicious cycle,” said lead author Eda K. Holl, assistant professor in Duke’s Department of Surgery. “Our goal was to break this cycle at its onset. What we saw in animals with lupus when we used these compounds was a dramatic reduction in inflammation, which gave the body a chance to heal.”

Sullenger and Holl said the approach was further tested to see if it compromised the mice’s ability to fight outside infections. When they exposed the treated mice to the influenza virus, the animals recovered from the illness even better than healthy mice infected with flu that had not undergone the treatment.

“This approach has the potential to treat a wide range of inflammatory conditions – from lupus to diabetes to even obesity,” Sullenger said.

He said the research team is continuing studies in animal models and working to start a company to develop and commercialise the scavenger The polymers home in on the DNA and RNA refuse from approach.

dying cells, halting the damaging

In addition to Sullenger and immune attack.

Holl, study authors from Duke include Kara Shumansky, Angela Burnette, Christopher Sample, and Elizabeth.

Ramsburg. They were joined by Luke Borst of N C State University.

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applerubber.com 14

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Visit our website to learn more.

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K SHOW

Special K

In October around 3,100 businesses from the plastics and rubber sector will be making their way to Dusseldorf for K 2016 (19-26 October). Visitors to the event will be able to see first-hand new products, processes and solutions for the plastics industry

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he global flagship fair for the sector and industrial applications, K unites central industry trends and future trends at a single venue. It has become established as the innnovation and business platform not only for raw materials producers, manufacturers of plastics and rubber machinery, and processors but also for stakeholders from the key user industries. Tailored materials, efficient use of resources, zero-defect production, generative production methods and digitalisation are just some of the technological trends featured at this year’s trade fair.

K 2016 has been booked out for months. Some 3,100 exhibitors from almost 60 nations will be taking part and showing their products and services on more than 170,000sqm of exhibition space.

Dressed for success at K 2016

According to Werner Dornscheidt, president and CEO of Messe Düsseldorf: “Nowhere in the world can one experience the full breadth of raw

Wear it well: Thanks to a combination of different Covestro products, wearable devices can cling gently to the skin and are comfortable to wear for extended periods.

Source: Covestro]

materials, processing and application equipment as completely as at K in Düsseldorf. This is the premier platform for the global plastics and rubber industry, and each company aims to present itself here with forward-looking innovations. Another unique feature is the high internationality of exhibitors and visitors. This ensures, firstly, that trade visitors can expect an offering of world market standard across the board. And, secondly, exhibitors here have access to industry experts from over 100 countries and come together with potential customers that they would not otherwise meet.”

The rise in digital and wearable devices has been evident over recent years.

They’re flat, flexible, inconspicuous and intelligent and small electronic devices that are fixed to the skin like a patch, are popular with consumers for sports and leisure activities or treating medical conditions.

Wearables have enormous market potential, even though there are still a few hurdles to clear. Covestro is driving the development forward with integral and sustainable material solutions that make the wearables more comfortable to wear while enabling further areas of application.

An important target group for wearables are consumers. The little devices can ascertain their level of physical fitness, measure body temperature and pulse rate, and evaluate quality of sleep. It’s expected that in the future, improved and even smarter products will

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also play a supporting role in medical diagnoses and treatments, and even deliver medications in accurate dosages. This would require them to remain on the skin for extended periods and be comfortable to wear.

“Consumers want wearables that cling gently to the skin, and that are also breathable and hypoallergenic,” said Gerd Büschel, a films expert at Covestro.

“We’re meeting this need with a clever combination of different materials. The patch is affixed to the wearer by means of a skin-friendly, breathable adhesive, which also is solvent-free and waterrepellent.”

For this, the company is offering custom-tailored polyurethane (PU) raw materials.

Covestro has a broad spectrum of know-how when it comes to the materials and their processing, and the company is looking for partners along the value chain who are interested in pursuing and coordinating further projects. “Developments like this are helping us make the world a brighter place,” says Büschel.

Making it matter Sabic will be exhibiting at K 2016 and showing visitors how ‘Chemistry that Matters’ is addressing global trends and the challenges in key industries with inspiring solutions to help create a better future for everyone.

The company will be placing a strong emphasis on sustainability at this year’s event, highlighting its collaborative approach with customers to jointly develop and produce global solutions, from concept to realisation.

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A new generation takes shape. s V i s i t u 16 0 a t K 2 l d o r f, sse i n D Ăź m a ny e G r

5 Hall 1 5 8 C Stand

Take the proven and tested, make it even better and explore something new – that is what makes ENGEL and their customers so successful.

Following our claim be the first, we will present a new generation of injection moulding machines setting new standards at K 2016. For now, we will entice you with this: We do not compromise on energy efficiency, ergonomics or precision. Do you want to know more?

Meet us at stand C58 in hall 15, starting October 19. www.engelglobal.com

K SHOW

Brush strokes: Engel technology is at work in the production of this new interdental brush]

Chemical world: Sabic will be exhibiting at K 2016 showing visitors how ‘Chemistry that Matters’ is addressing global trends]

“Striving for a sustainable future means looking at business practices differently and being able to turn challenges into opportunities that add lasting business value,” said Abdulrahman Al-Fageeh, executive vice president polymers.

“Our new organisation brings us closer to customers, enabling us to offer sustainable solutions to the entire value chain and move further toward our vision to be a preferred world leader in chemicals.”

Sabic will feature new, sustainabilityenabling materials and breakthrough technologies it has developed in close collaboration with customers. With the focus on key industry segments including packaging and healthcare, the company will display specific, innovative applications, such as renewable packaging.

New additions Additive supplier Vertellus will be introducing new high-performance additive technologies that it says help meet increasing industry demand for improved material performance and sustainability. Among these will be the launch of a new family of masterbatches for use in plastics compounding as a compatibiliser for polyamide (PA) combined with recycled polyethylene terephthalate (PET), and as a chain extender to produce branched high RV polyamides with lower material and processing costs.

Elix Polymers claims to have an unmatched service portfolio, appreciated by customers for its short lead times, problem-solving capabilities, flexibility and reliability. The company sells into multiple end-user markets including healthcare devices.

Brush up on innovation For a perfect example of medical expertise at play head to the Pheneo stand at K to see the launch of its new interdental brush. According to Engel the production process on this product is a world first as up to 500 bristles can be moulded directly in singlecomponent injection moulding together with the core and the grip.

The cleanroom version of an all-electric Engel e-motion 170/100 T injection moulding machine will process a three-component compound. The high-performance precision mould with eight cavities (which is extremely delicate in the bristle area) comes from Hack Formenbau. Hekuma is responsible for the automation. The presentation showcases a highly integrated, automated production cell using Hekuma’s HEKUflex design.

Immediately after injection moulding, the parts are camera inspected and the good parts automatically packed into retail sales bags, 16 pieces each. One bag leaves the production cell every four seconds.

How to create the exceptional ‘Create the Exceptional’ - this is the motto of Evonik Industries, specialty chemical provider. At K 2016 the company will present solutions and creative ideas developed in close collaboration with customers.

In addition to innovative plastics, Evonik offers a range of monomers and additives. For the medical sector it’s worth taking a look at VestaKeep PEEK which is biocompatible and can be used, among other things, for spinal implants, bridges, crowns in the dental area, in orthopaedics, and also pharmacy.

Evonik says that Cyrolite multipolymers are the world’s most highly developed PMMA-based polymers for medical technology. They meet the requirements of USP Class 6 and 26, Tripartite, ISO 10993-1, and FDA. They can be sterilised with gamma radiation and ETO gas as well as being resistant to lipids, offering good impact resistance, transparency, and light transmittance.

Typical applications include disposable medical articles, such as IV and catheter accessories, blood/plasma collection containers, thoracic drainage sets, accessories for respiratory apparatus, medical filters, and device housings.

Products featured by the company will include replacement phthalates in medical and baby products with nontoxic, bio-based plasticisers.

Health service: Head to the Vertellus stand to see its replacement phthalates for healthcare products

Debut performance 2016 will see Elix Polymers making its first appearance at the K show. The company is a specialist producer of ABS and SAN polymers, high performance compounds, polymer blends and also polymer modifiers and its lineage includes names such as Bayer, Lanxess and Ineos.

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NEWS FOCUS: K SHOW

BREAKING the mould

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K

hree years ago, Ultrasion burst into the precision moulding sector with its ultrasonic moulding technology. Since then, ultrasonic moulding has been used by OEMs Ultrasion will be launching the throughout Europe, newest version of its ultrasonic the United States, and the Far East to solve moulding technology at the problems impossible Show in Dusseldorf in October, using conventional opening up the process to an moulding technologies.

array of OEMs across the world

At this year’s K Show in Dusseldorf in October, Ultrasion will launch its latest ultrasonic moulding machine. The machine aims to appeal to a range of manufacturers focused on precision moulding.

Enric Sirera, general manager at Ultrasion explains the new developments. “When we launched our first ultrasonic moulding machine back in 2012, we were overwhelmed by the interest from manufacturers world-wide. The first version of the technology was focussed on micro moulding projects, being able to manufacture parts with a shot weight of 2 g and lower. It was also ideally suited to prototyping and research projects, and machines were sold extensively throughout the United States and Europe, with recent uptake in the Far East.”

“The launch of the second version of the machine is exciting for us, and for manufacturers of precision plastic parts, as the new version of the technology accommodates larger shot weights and is ideally suited to mass production. This represents a massive opportunity for plastic manufacturers, as the benefits of ultrasonic moulding can now be introduced to countless moulding projects.”

There are good reasons why manufacturers are so excited about ultrasonic moulding, with Dennis Tully, president of MTD Micromolding saying that “ultrasonic moulding is the most radical approach to moulding in probably 100 years.”

Ultrasonic moulding opens up opportunities for plastic part manufacturers by overcoming problems inherent in precision moulding. The technology was built to address these issues, key among which is material degradation by dramatically reducing the thermal history of the polymer being processed.

reduced by up to 90% depending upon the precise nature of the application. Energy is only imparted as the sonotrode is on contact with the plastic to be melted per shot, so 90% energy savings can also be achieved.

Ultrasion R&D Manager Alfonso Pascual discusses the nature of the process. “Plastic melted through the use of ultrasonics exhibits radically different and advantageous characteristics when compared with plastics melted through the use of traditional heater bands. Key is that ultrasonic melting reduces the viscosity of melted plastic, this being a bi-product of the ultrasonic agitation itself which increases the free volume between the molecules in the melted polymer, and the fact that the sprue concept in the Ultrasion technology means that it behaves as an energy director as well as part of the ejection system.

The energy director orientates the waves in the flow direction, therefore the molten material and waves travel together toward the cavities, reducing the viscosity of the polymer.”

The high intensity mechanical vibration transmits energy directly into the polymer molecular structure resulting in a fast and efficient melting “insideout” rather than “outside-in” which is typically how melting occurs in injection moulding via electric heaters. Reduced material viscosity also means that the moulding pressures required are significantly reduced compared with traditional micro-moulding technologies, which ensures that the material remains relaxed during the moulding process, meaning less shear, and more conformity and uniformity in moulded parts. This is especially critical for optical components where low birefringency levels must be achieved.

Sirera concludes: “Lower moulding pressures means that there can be tooling costs savings as there is less wear and tear, but more importantly means that it is possible to use delicate and precise core pins and insert configurations that would break under normal micro moulding pressures. The low moulding pressures (in addition to their importance for optical applications) also make the ultrasonic precision moulding process ideally suited to over and insert moulding applications, with success being achieved with no damage to the overmoulded parts.”

Material degradation is a product of the residence time of melted plastic heated in advance of its injection into the mould. Residence time occurs in all traditional technologies that rely on screws, barrels and heater bands.

Ultrasion eliminates material degradation by removing screws, barrels and heater bands and instead doses the precise amount of material needed per shot direct to the mould where it is melted in-situ using an ultrasonic horn (sonotrode).

The technology uses standard room temperature pellets – they are melted and injected in one process eliminating residence time and material degradation.

There is no purging necessary with the ultrasonic injection moulding machines and material wastage is 20

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Making a debut: The K Show will be the launch event for Ultrasion’s new ultrasonic moulding machine.

NEC BIRMINGHAM, UK | 26-28 SEPTEMBER 2017

INJECTION MOULDING

EXTRUSION

ROTATIONAL MOULDING

BLOW MOULDING

RECYCLING

THERMOFORMING

MATERIALS

VACUUM FORMIN G

D ES I G N

FILM EXTRUSION

EXHIBIT NOW

www.interplasuk.com

www.netstal.com

Are you looking for an injection molding system for certified production to the highest of standards? Do you need to supply your customers with superior quality health-care products? Then Netstal injection molding systems are a must have! Our team is made up of experts specialized exclusively in the manufacture of medical components.

This guarantees maximum output at a consistently high level of quality.

K2016, hall 15, booth B27/ C24 / C27/ D24

Outstanding quality High returns Engineering Excellence

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COVER STORY

the genuine article P

roduct counterfeiting is a serious problem for industry and consumers alike. As system provider, Netstal has tackled this problem and together with its partners, says it is able to offer its customers reliable and inexpensive solutions. At Michael Birchler, this year’s K Trade Fair, Netstal will Netstal, explains how the demonstrate these solutions with the company is helping tackle help of the first ever 128-cavity pipette tip production line.

Plastic products can be counterfeited fairly easily.

Basically, all it takes is an injection moulding machine and a copied mould acquired from a dubious source.

“According to an Ernst & Young study, approximately 80% of all companies globally are affected by the counterfeiting of merchandise,” said Dr Patrick Blessing, head of Netstal’s Medical Technology and Precision Parts business unit. Statistics published by the European Union show that around 36 million counterfeit products are being confiscated annually by the customs authorities of member countries. At the same time, reports are on the rise about significant harm caused by the consumption or use of counterfeit brandname products. The risk potential nowadays is great and continues to rise. However, counterfeit products do not just pose serious risks to people, animals and the environment. In the worst-case scenario, brands affected by counterfeiting can suffer from a loss of image that cannot be fixed in the short term. Therefore, companies are increasingly looking for ways to label their products as absolutely forgery-proof in order to optimally protect themselves and the consumers of their products from harm.

In particular, the appropriate devices can electronically detect markings invisible to the human eye – easily and inexpensively. For example, thanks to an integrated testing process, a laboratory machine can determine whether it has been stocked with original consumable materials or not. The work of customs agents is also greatly facilitated by the ability to clearly and quickly identify counterfeit products. Whether on food packaging, clothes, electronic components or consumable articles in the medical industry, there are countless areas of application in which such markings are a sensible and increasingly important new feature.

the growing problem of counterfeiting

“Therefore, Netstal will also provide solutions to this problem – very much in accordance with our systems approach. By using smart tools, it is possible to add both visible and invisible markings to products during the injection moulding process,” Blessing explained.

Solutions that provide protection Together with the Swiss company U-Nica, Netstal will demonstrate this technology for the production of pipette tips at this year’s K Trade Fair.

Global first: In the world’s first mould with 128 cavities, the pipette tips will be produced with a cycle time of 5.6 seconds,

in-mould Intragram for the pipette tips

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COVER STORY

Light works: A masterbatch mixed into the plastic granulate contains additives visible as dots when examined with light featuring a certain wavelength

“As part of a demonstration, individual pipette tips will be equipped with visible holograms, which significantly increases their protection against forgeries,” emphasised Blessing. The Intragram technology developed by U-Nica features nanostructures and can be integrated into new or existing moulds with little effort. In the end, each pipette tip gets a visible hologram in the same place, which allows for an identification without any technical aids – similar to a banknote. And since the hologram is embedded in the product, it cannot be removed and is easily distinguishable from holograms pasted on at a later point.

An additional anti-counterfeiting tool is the Spectrotag technology that is invisible to the human eye. Here, a socalled masterbatch is mixed into the plastic granulate.

“The masterbatch contains special additives that become visible as a pattern of dots when examined with light featuring a certain wavelength,” explained Dr Blessing.

With a small magnifying glass with integrated light, a simple test at the trade fair booth will determine if it is an original pipette tip or a forgery. In industrial applications, the authentication check can be done fully automatically with state-of-the-art picture processing technology.

The first 128-cavity pipette tip production line In order to get the world’s first production line of pipette tips with 128 cavities up and running, Netstal partnered with two other companies nearly 18 months ago. In what is currently the world’s only mould with 128 cavities from Tanner Formenbau, the pipette tips will be produced with a cycle time of 5.6 seconds, which corresponds to a daily output of around 2 million units. Despite this huge production volume, it is important to bear in mind that the pipette tip is a piece of medical technology and an extremely delicate component with a wall thickness of 0.38 mm and a part weight of just 0.26 g that is only possible with the tightest of production tolerances. The high precision-controlled process of the all-electric Elion 2800 injection moulding machine from Netstal ensures that the shot weight of 33.28 g is distributed in equal parts across the 16 clusters with 8 cavities each. The very high process consistency of the injection moulding machine assures equally high parts quality in continuous operation.

“Our automation solution does not require a larger setup area than a comparable 64-cavity system. That means that manufacturers of pipette tips are able to double their productivity while using the same amount of space,” emphasized Andreas Schmid, CEO of Zubler Handling. A composite removal gripper made of carbon and aluminum removes the 128 pipette tips during a moud open time of less than 0.9 seconds. The presence of each individual part is checked at the same time. The pipette tips then directly and separately (according to cavity) go onto the tray.

“To ensure the high quality of the sensitive product, there is no reaching into the collar at any time and the outlet opening of the pipette tip also remains untouched,” remarked Schmid.

Although the complete automation solution has a very compact construction, the space available on the exhibition area would still be exceeded. For this reason, the subsequent tasks – such as filter configuration, quality control with industrial cameras and automated packaging – will be demonstrated via installed monitors.

Systems completed at any earlier stage, which meet the high removal performance and have passed the strict qualification process, can be called upon for this. Such productions have already been realised in Germany, Switzerland and the US.

Collaboration with partners Together with specialised partners from the fields of mould making, robotics and automation, Netstal develops customised production systems for its customers. This offers customers numerous success factors that result from cooperation with Netstal. Access to an independent partner network guarantees the best possible customer solution and provides maximum flexibility in the selection of system components. On-site system integration and commissioning is especially efficient and requires a minimal coordination effort. A complex system solution ultimately always comprises subsystems of different manufacturers that must still function seamlessly with one another. That is why it is also strategically advantageous for the user if there is a contact person available in after-sales service for the complete system.

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Quality in its purest form.

With passion, we develop future-oriented inspection and sorting devices for the quality assurance of plastic pellets, such as the PURITY SCANNER. A so far unique solution, which combines X-ray technology with an optical inspection. A technological progress significantly increasing the quality of material and end products and saving costs.

– detects contamination from 50 μm inside the pellet and on its surface by X-ray and optical cameras – purest material and highly qualitative end products due to automated sorting – efficient production without time-outs and scrap – suitable for different applications indepenindepen dent of material and color

www.sikora.net/purityscanner Visit us from October 19-26, 2016 at the K in Düsseldorf, Germany.

Hall 10, Booth H21

Q&A

Q&A

TUBE JOURNEY Rudi Gall is the vice president marketing & sales at Raumedic, which serves medical device OEMs. Gall outlines market trends and challenges and shares his insight into the tubing sector both now and the future What trends are you seeing in tubing?

There is a trend to unite metals – such as stainless steel – and plastics. Medical devices are incorporating more challenging designs and need to be able to deliver an increasing level of performance. There is a trend towards minimally invasive procedures, requiring smaller devices, made from micro-components, parts and tubing.

We have a growing trend for medical device connectivity, where data is transferred from the medical device / patient to an analytical or diagnostic system. This ‘real time data’ allows for prognostic and strategic medical care of patients with the benefit for immediate treatment and prevention of critical health issues.

New neurological and neurovascular devices are a perfect example – thermoplastic polymers, metals and electronics morph into one product. One such device is Raumedic’s intracranial brain pressure catheter (ICP) which consists of a single lumen implant-grade polyurethane catheter protecting the wiring leading to a microchip embedded in a stainless steel tip at the distal end of the catheter.

What do OEMs want most from tubing?

They want high, persistent quality of products that ideally exceed their expectations. The medical device market does not like changes and acts nervously when quality is at stake. This is due to the invasive nature of some medical products and the regulatory framework of the medical device market.

Any recent technologic advancements and how have they made things better or more efficient?

One specific technologic advancement I would like to single out is the market launch of medical-grade Raumedic PTFE Moldflon tubing which is a symbiosis between PTFE properties and thermoplastic processing capabilities. It has similar physical properties as standard PTFE – high temperature and chemical resistance, very low coefficient of friction and tensile strength. The big difference however is that PTFE Moldflon is pelletised and can run continuously on a standard extrusion line, whereas traditional PTFE is a batch process and therefore non-continuous using RAM extrusion lines.

What are the challenges with new or advanced materials when it comes to tubing?

In recent months we have seen an interest to substitute PVC tubing with alternatives.

Alternative materials to PVC could be thermoplastic elastomers (TPE) or polypropylene blends (PP). TPEs however

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are not easy to bond to other substrates, such as polycarbonate (PC) or ABS connectors, which are widely used in standard IV tubing sets. Good bonding characteristics can be achieved with PP tubing using tetrahydrofuran (THF).

However both TPE and PP both come with a high price and are not even close to the production costs of PVC. PVC will therefore stick around for the time being, until there is a political mandate to move away from it in the healthcare industry.

What examples do you have of innovative tubing solutions that met challenging OEM requests

One challenge was to heat-bond a tight tolerance microbore PVC tubing into a tubing coil as a space saver. To heat bond PVC is not a challenge but keeping tight tolerances on the tubing ID and OD, as well as on the tubing coil diameter is, as PVC has a low melting point. PVC tubing reacts and changes its characteristics in elevated temperatures resulting in out-ofspec dimensions. When heat-bonding PVC tubing in a secondary process the change of the material therefore needs to be carefully dialed-in to the production / extrusion of the tube so that an end product can be produced on basis of a statistically reliable process.

What might OEMs think is impossible but is actually possible when it comes to tubing?

How about integrating a miniature camera into a bi-lumen micro tube? Raumedic’s intelligent catheter capabilities include a chip-on-tip integration of a tiny camera probe and polymeric optical fibre within the distal tip of a nylon bi-lumen micro tube.

Any breakthrough advances on the horizon that will make tubing a lot better?

One topic which will somewhat change the current medical tubing landscape will be the introduction of bioabsorbable polymers such as PLLA / PLGA. Such materials are however expensive so tubing suppliers need to understand the extrusion process and the negative impact of a prolonged residence time on the physical properties of the tubing and the end device. Also concentricity (uniform wall thickness) of such tubes is very critical. Raumedic’s micro extrusion lines are capable of running very low volumes of such expensive formulations with minimal residence time.

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EDTEC CHINA VISIT US AT: M R 26-28 BE O CT O P302 TH AT BOO

EMERGING MARKETS

EAST MEETS WEST G

iven that over three quarters of the world lives in emerging markets, opportunities for growth for global industries should be strong. For the healthcare and life sciences sectors the potential to explore Opportunities for medical new business territories looks device companies in China promising as technology and expand across and the Asia Pacific region procedures borders to improve the health continue to be strong. and well being of the global However, businesses need population.

to consider the regulatory framework in place designed to protect and encourage domestic manufacture, says Lu Rahman

Back in 2011 PwC noted that, “emerging markets, led by China, India and Brazil, are gaining ground in their capacity to products the latest in medical technology innovation and may surpass developed countries in innovative healthcare delivery over the next decade”.

GlobalData recently reported that while in the US and Europe the hip and knee construction market haven’t been showing signs of growth, the same isn’t true in Brazil, India and China. Thanks to a burgeoning middle class which can afford healthcare, opportunities have increased in these regions. The company’s report states that as well as the booming populations of these countries containing individuals with the financial ability to access a new quality of healthcare, increased levels of training within the healthcare sector are also taking place, which should boost adoption of new techniques and products.

Linda Tian, MSc, GlobalData’s managing analyst covering medical devices, said: “There has been a slow and steady change in patients’ mentalities in developing countries, and more of the elderly are now willing to undergo the required joint replacement surgeries. Heightened public awareness will not only accelerate surgeons’ adoption of different types of implants, but will also effectively propel market growth.”

While opportunities exist in this region, there are challenges to overcome. Earlier this year McKinsey & Company published a report by Amit Agarwal, Franck Le Deu, and Florian Then – Meeting growing Asia–Pacific demand for medical technology.

It stated: “Asia–Pacific is a complicated collection of individual markets, often with little in common other than a shared continent. Political systems, economic development, cultural mores, and disease profiles, among other characteristics, vary widely from one country to the next. While other industries, such as high tech, have been relatively successful in approaching these complexities, med-tech companies are still finding their way. Although they’ve long been active in Asia–Pacific, these companies traditionally cater to premium customer segments.”

The report however highlights that by 2020 things will change and the Asia-Pacific market will become the second biggest market globally after the US with the majority of customers coming from “beyond the premium segment”.

McKinsey & Company advises that to gain access to these customers and “defend against new competitors, global companies will have to rethink their approach to the region, creating new business models that encompass multiple channels, developing market-appropriate products rooted in innovation, allowing greater local autonomy, and removing structural barriers.”

The main obstacles facing med-tech companies in this region were found to be “limited financial resources and a frugal attitude toward spending on healthcare; multiple customer segments that are difficult to serve efficiently; an underdeveloped medical infrastructure and workforce, which affects the adoption and use of new technology; fragmented and inconsistent regulatory and reimbursement regimes that can slow the introduction of new technology, and intense competition from regional start-ups and, increasingly, global leaders in adjacent industries such as high tech and consumer electronics.”

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INNOVATING TOGETHER

Freudenberg Medical is a global partner for the design, development and manufacture of innovative medical device technologies. Our comprehensive technical capabilities range from the design and manufacture of minimally invasive, catheter, and handheld technology to the development and production of medical components utilizing complex materials and processes. We are leading the way in manufacturing high precision silicone and

thermoplastic components and tubing as well as metal hypotubes. Freudenberg Medical is part of the Freudenberg Group, a global 165-year old technology group that develops innovative products and services for more than 30 market segments worldwide. As an organization, we ensure that every project is supported by our unmatched range of global resources, financial stability, and the flexibility to optimize for business performance.

www.freudenbergmedical.com

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mediprene@elasto.se • www.mediprene.com

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One area of medical plastics that is showing strong growth in the region is aesthetic improvement. A recent report in China Daily highlighted the growth in this market and its potential to become the world’s second largest market by 2019. While some of this is due to the rise of Botox and facial injections, there has been a movement in the region towards aesthetic improvement which will bring increased opportunities for the plastics surgery and implant markets too.

The conventional medical device sector in the region is also showing good signs. Writing in The Star Online, David Tan, described how “the medical device segment is proving to be a lifesaver for plastics manufacturers in Penang”. Given the slowdown in sectors such as semiconductors, this is good news. His article cites Rapid Growth Technology, a company that is planning to invest in a production line to manufacture a disposable medical device for a US customer. The company is also looking to make moves into the South-East Asian market.

Tan also uses talks to Cepco Trading. This business is targetting the medical sector with its high-impact polystyrene sheets which it is hoping will contribute to about 30% of its revenues in three years’ time. The company’s director Jansen Lim tells David Tan that because of the decline in the semiconductor and food and beverage businesses, the company decided to move into the medical device sector which he says is “more consistent”.

China is a particularly interesting example. Companies such as Siemens AG, Johnson & Johnson, Philips NV and Medtronic have already shown an interest in China’s fastgrowing medical devices market but there has been a move within the country to encourage locally-made products and the government has introduced a set of measures aimed at making this happen.

In 2014 China’s ministry of health issued a statement via its website which explained that it would promote the use of Chinese products to “effectively control unreasonable increases in the cost of medical care and reduce the burden on patients”.

Home grown: Within China’s medical device market but there has been a move within the country to encourage locally-made products with measures aimed at making this happen

The statement quoted Li Bin, head of China’s national health and family planning commission who said: “We want to strongly advocate health ministry organisations to use domestically-made medical devices, especially As part of the push towards localisations, domestic hospitals are being encouraged to use Chinese-made medical devices. This will see the country become a major manufacturer of medical devices as well as a supplier. It has also closed the ‘research only’ loophole that allowed European and US businesses to send their medical devices to China for non-commercial use. Not only did this allow companies to skirt round complicated registration processes, it also meant that organisations were able use many devices before receiving approval. Consider the country’s ban on refurbished imports and it’s obvious how much the country is looking to protect local products.

One company that has entered the Chinese market is Carclo Technical Plastics. This UK-based manufacturer

specialises in technical mouldings and its products include drug delivery devices and diagnostic consumables. In the past, Carclo would export its product to China. However, this became a logistical challenge – exporting a container would often cost thousands of dollars by and the shipping alternative wasn’t much better as it could take up to 45 days.

The company moved its production to a new facility in Taicang, China. By localising production right in China, it believes the benefits were significant for the customer. It also removed expensive freight costs as well as heavy customs fees.

There was also a small savings in labour since the product was now manufactured directly in China.

However, perhaps most importantly, the company’s facilities no longer had to carry as much of the product because lead times improved significantly.

Of course, Carclo isn’t alone in its pursuit of the Chinese market. In 2014 Gerresheimer opened a new development centre for medical plastic systems in Dongguan City. Andreas Schütte, Gerresheimer management board member with responsibility for plastics & devices said: “The new centre in China ensures that we can optimally meet the growing demand in the Asian market. In future, we will have development operations in addition to local production operations and we’ll be collaborating closely with our customers in China.”

In the same year GW Plastics expanded its manufacturing facility in Dongguan offering in-house tool building, cleanroom moulding and assembly and shipping of finished medical devices. The year before Stryker Corporation acquired Trauson Holdings,

China’s leading producer of spinal products, for $764 million while Medtronic completed the acquisition of a Chinese company Kanghui Holdings, an orthopaedic implant manufacturer in 2012. With Chinese headquarters already established in Shanghai, the company also unveiled a research centre in Chengdu for the design of devices specifically for China’s rural healthcare sector.

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TESTING

TEST CASE T

he painful expenses associated with failed devices are avoidable by an upfront investment in reliable analysis of the materials and devices. These upfront costs, ranging in the thousands of dollars, could avert spending Caitlyn Scaggs, Polymer millions or billions, if a product Solutions Incorporated, is recalled.

outlines the key aspects for consideration when choosing an independent testing lab

The highly regulated medical plastics industry demands scientific support to ensure materials and finished products will function as expected and are safe. However, maintaining a variety of analytical instrumentation on site is typically cost prohibitive and not a wise business decision. It isn’t as simple as acquiring the right analytical instrumentation, there must also be strong expertise to properly use the instrumentation and produce reliable data. Therefore, the need to partner with an independent testing lab, also known as a third-party testing lab, is necessary and business-critical. Independent testing labs can supplement the work of any medical plastics firm and serve as a force multiplier of a processer’s own staff.

It isn’t hard to find a plethora of independent testing labs with a quick Google search. What is more challenging is determining which lab has the infrastructure, internal processes and value propositions that will meet your needs. Since the role of the independent lab is missioncritical, it is necessary to carefully evaluate a testing lab prior to initiating analysis. There are three key areas to consider when evaluating an independent testing lab.

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A robust quality infrastructure You wouldn’t trust your health and well being to a physician that didn’t pass their medical boards—why would you trust high-consequence laboratory testing to a company that lacks proper accreditation? If you’re developing a product that will have end use within the medical industry you need assurance that the results supporting your product are reliable. Verifying a testing lab has up-to-date and relevant accreditations, certifications, and registrations is a great starting point. These items are an initial indicator of a lab’s commitment to quality practices but dive deeper into their quality system as part of your evaluation.

A quality system at an independent testing lab isn’t simply producing “high quality results”. It involves emphasis on sample control, data integrity, document control, trackability, and traceability. As a first step, an independent testing lab can be asked to fill out a paper audit, to ensure the basics are in place. An in-person audit will be much more telling and would be a great next step, if the paper audit warrants proceeding with the business relationship.

As part of a testing lab’s quality infrastructure there should be documented procedures in place for when unexpected results are obtained. While applicable to anyone within the medical plastics industry it is especially pertinent for companies that conduct regular lot release testing in which there are clearly established specifications. Testing labs with a robust quality system will have procedures in place for situations in which test results do not

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TESTING

meet client expectations or when they are outside the predetermined specification. These out of specification (OOS) investigations are a critical review of how the testing was conducted to rule out human, instrumentation, or documentation error. Documentation of lab activities, equipment calibrations, work instructions, training records, raw data, and calculations are some of the items that should be reviewed as part of an OOS. If a lab cannot clearly and confidently talk through OOS processes then it warrants looking elsewhere for analytical support.

Long term value Testing medical devices and raw materials used to manufacture medical devices is not a one-and-done activity. Even after a product has been approved, is on the market, and in-use with human patients there is still the need to proactively ensure safety and proper performance.

Partner with a lab that has the capacity and capability to provide regular lot-release testing to preemptively catch any issues that might arise with a product lot or lot of raw material. This is particularly important for bioabsorbable materials used within medical devices. Certain properties, such as molecular weight, have a direct impact on how the device will perform in the patient’s body. Conducting regular analysis to confirm devices are being produced within the correct range of molecular weight values is protects the financial interest of the company and most importantly the well-being of patients. Not all testing labs have the capacity to handle this type of testing on a regular basis, nor do they have the systems in place to regularly accommodate prompt turnaround times on such samples.

This speaks to the need to carefully vet the testing lab well on the front end, to ensure the relationship can be long lasting and meet a variety of needs.

of the product is the best practice. Finding one lab that can be there from the start protects the financial interests of the company and the safety and success of the product.

Another aspect of evaluating the long term values is to carefully consider the costs. Sometimes the price tag associated with a proposed testing plan causes sticker shock. Work with the testing lab to understand the reason for the cost, rather than being shut down by the price.

There is always someone out there who will do it cheaper, but can you afford the cost of conducting testing in a way that casts doubts about reliability? The painful expenses associated with failed devices are avoidable by an upfront investment in reliable analysis of the materials and devices.

These upfront costs, ranging in the thousands of dollars, could avert spending millions or billions, if a product is recalled. More importantly, it would prevent putting a patient’s life or well being in harm’s way.

A Partnership that meets needs It may sound trite, but consider if you want to be able to quickly reach a warm-body on the other side of the phone as a moment’s notice. Also assess the lead time on how long it takes to receive an estimate for projects, standard turnaround time, and expedited options. It is hard to predict when analytical services will be needed, especially when failure analysis or contamination analysis is required, so available staff is a must. You need a partner that will respond to your needs whether the testing required is for research and development purposes or is a rapid response to a product failure.

It’s also not enough to have the right testing instrumentation or a really smart group of scientists. Those two things must be combined to provide the solutions required by highdemand and high-risk organisations. If the technical staff can’t provide ideas and collaborate are you really finding a partner or just a vendor?

Also spend time assessing if the technical staff will be within reach or hidden behind a layer of administrative staff, in effect making them inaccessible. This is problematic in almost all scenarios, even if the client is highly technical.

When the technical representatives of a company are hard to get in direct contact with it hinders productivity of projects and can result in the “telephone effect” of confusing and confounding results. Make sure there are direct communication lines with the technical team, and ideally a project manager, that has a strong technical background both academically and within industry. When evaluating a potential business relationship with a testing lab consider if the testing lab takes the time to talk with you and your team on the front end, to make sure your analytical needs and the context of your needs are fully understood. For example, should a method be validated in advance? A lab slow to respond to potential business or quick to provide a testing plan without a thorough evaluation are both a cause for concern and a red flag worth heeding. If they are someone you cringe at having to work with and don’t meet your expectations, a longterm relationship isn’t likely. Choose a lab with people that care about your problem and answer your questions in a thorough and prompt manner.

Test it out: The highly regulated medical plastics industry demands scientific support to ensure materials and finished products are safe

It is also valuable if the same lab develops a method and then carries out the subsequent testing. They will be familiar with the ins and outs of the method and more efficiently execute the analysis. It also eliminates concerns over instrumentation equivalency that would be present if two different labs were used for method development and later testing. Utilising the same lab for method development and analysis also helps clearly define trends that may be occurring with the material and resulting data.

Continuing the partnership throughout the entire lifecycle

Evaluating the quality infrastructure, determining the long-term value, and ensuring the partnership will meet your unique needs are three areas to carefully evaluate in advance of analytical testing. For anyone with a role in the medical plastics industry, the need for analytical support is too dire to act upon without doing diligence as to the available options. Choosing the right testing lab saves time, money, and ensures the best possible outcome for the patients that ultimately use the medical plastics and associated devices.

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MHEALTH

On the move I

t’s a fact of life, convenience is expensive. However, new research in the healthcare industry is challenging this long-held notion, showing that in the US, house calls— possibly the epitome of convenience—cost less than in-office healthcare in the long term. Since doctors on the go need equipment that goes just as easily, the future is looking very dynamic for medical device manufacturers.

Tim Jennings, Custom Case Group, explains how the trend for mobile medicine in the US is leading to new considerations for portable medical device R&D

Industry developments Encouraged by this kind of research, more companies are jumping on the mobile medicine bandwagon. Several innovative business developments have recently hit the news. These include:

Heal

Recent research A slew of research has emerged in the past few years, revealing that the trend in the US for house-call-style healthcare is picking up steam. Following are three of the more recent additions to this growing body of evidence.

A first-year analysis of the Independence at Home program, created by the Center for Medicare and Medicaid Innovation, showed that the program saved Medicare about $13,600 per patient in 2014, with a total reported savings of $25 million.

A 2014 study in the Journal of the American Geriatrics Society showed that, over a one-year period, house calls saved Medicare 17% by reducing hospital and nursing home admissions.

This year, a report prepared by the online publication Health Affairs and the California Health Care Foundation (CHCF) showed that an in-home medical and wellness care programme for senior and homebound patients saved money over time. Researchers accounted for the possibility of higher costs as more patients aged into the program, as well as operational differences across regions.

Dr Renee Dua developed the Heal App for mothers who, like herself, were frustrated with the inconvenience of children’s medical care.

With the app, parents can schedule house calls every day from 8am to 8pm with a licensed physician who arrives within two hours. Heal currently only serves a few cities in California, but apps like it are popping up all over.

Gerrard This sterilisation robot developed by Xenex has been a favorite among hospitalised children for years. In July, though, Gerrard’s job took a new turn. Eleven-month-old leukaemia patient, Vaughn LaMarque, was released from hospital on July 4. Though everyone was glad Vaughn was healthy enough for release, the family would miss the ‘friendship’ and excellent sterilisation the robot provided.

The LaMarques asked Xenex if Gerrard could make home visits for Vaughn’s sake. Xenex said yes, and Gerrard became the first mobile robotic doc.

Express Care at Home When Providence Saint John’s Health Center in Santa Monica was looking for a new way to simplify patient care, its research led them to launch Express Care at Home. This house-call-style programme, which launched in July, incorporates a mobile app like Heal. Patients schedule visits with Providence’s health care providers who can provide examinationss, make diagnoses and write prescriptions for non-acute illnesses. The docs will even come to a patient’s hotel room.

What it means for medical plastics Not surprisingly, portable medical devices R&D is picking up speed alongside this trend. And as the healthcare model becomes increasingly mobile, protection and transport features are becoming even more critical in the design and engineering of medical devices.

Obviously, the R&D of portable devices has always considered the elements of portability, but the house-call trend could shift things in such a way that the features around protection and functionality will be paramount.

This shift could give medical plastics manufacturers a unique opportunity for growth. If mobile health care is destined to become the norm rather than the exception, protection and ease-of-use will become highly competitive areas of design engineering. In the future, it is likely that everything from dialysis and MRI machines to transcutaneous electrical nerve stimulation systems will need to be easy to move and carry. These machines will also need to be impervious to the everyday bumps, drops and vibrations a mobile health care system is sure to bring. Plastic technologies will be the gold standard for addressing these needs.

Those of us on the plastics side of the medical device industry, then, would be wise to shift some of our creative focus to innovations in this area. To support the health care system of the future, we’ll need to start viewing external and internal portability and protection features as integral elements, rather than afterthoughts, in the overall design of these critical devices.

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THERMOFORMING

Sealed bids E

nsuring seal integrity is critical to the product efficacy of healthcare packaging, as the seal maintains necessary sterile barriers. Seals must always remain intact under the strains of shipping and Egan, Nelipak handling, yet peel open quickly and easily for the end-user in a surgical environment.

Sean Healthcare Packaging, discusses best practices for healthcare packaging seal integrity

Understanding and applying best practices during the heat sealing process and using custom built cleanroom sealing machines designed to the specifications of a medical device, pharmaceutical thermoformed blisters or trays can result in better quality products that consistently have the necessary seal strengths and properties.

In the heat sealing process, coated lidding material is activated under controlled pressure and temperature parameters creating a bond between the tray/blister and the lidding material. After cooling, this bond is tensionable and the pack is considered sealed; the quality of this seal can be evaluated either visually and/or mechanically.

Factors to consider in establishing a consistent heat sealing process are:  The sealing machine  Heat seal parameters, such as pressure, temperature and time  The sealing dies  The blister  The lidding material  Impurities on the blister and/or lidding material It is important to establish the lower and upper limits of the sealing process during the validation stage. This makes it possible to take into account fluctuations during the sealing process. Using blisters and lidding material that are known to give a good seal when the machine is set in a certain way can help track down batch discrepancies.

If these are introduced into the process when problems occur it can quickly be determined whether the blister or the lidding material is the cause.

When changes occur, they may result in serious complications with the bond between the tray/blister and the lidding material. Changes to the sealing machine, the heat seal parameters and the sealing dies are usually easily observable. If they are the reason for the problems, ‘the original state’ should be restored and the process can resume as normal. However, if the blister or the lidding material is the cause, the resulting changes are often not discernible with the naked eye.

Some characteristics observed from peel testing may be a subjective matter of opinion – such as whether the seal ‘looks nice’. What is more important is whether, after peeling the seal, you can establish a basis of properties that indicate what to expect from the applied coating in a certain combination of blister and lidding material.

Minimising the risk of impurities Impurities that lodge between the blister and the lidding material give rise to poor visual and mechanical bond properties. Therefore, consider the following best practices for reducing impurities:  Leave lidding material and blisters in the original packaging for as long as possible  Avoid touching the coating, especially at the points where joints will be made later  Avoid touching the blister’s sealing flange  In the case of pre-treatment of blister and lidding material (such as sterilisation), keep a few originals in reserve so you can verify whether the pre-treatment has affected the quality of the bond  Test the effect of disinfectants or detergents on the quality of the bond in advance (even if they are not meant to come into contact with the blister’s seal flanges)  Test the effect on the seal of gloves that you do or do not use in combination with disinfectants or detergents  Test the effect of the contents of the packaging on the quality of the bond, particularly if you work with liquids or sticky substances Problems involving blisters and lidding material are usually due to material from different production batches being used during one sealing cycle –for example, blisters sealed in a single cycle with lidding material that has identical coating but is from two different batches. They show not only different results in the peel test, but also visual differences. This can usually be solved by modification of the heat seal parameters.

Hot topic: Ensuring seal integrity is critical in healthcare packaging. A heat sealing with NX-T1 table top sealer

Evaluating heat sealing Conclusions drawn regarding the quality of bonds are not always found to be correct, particularly when the evaluation is based solely on visual inspection.

Sometimes seals whose quality is actually satisfactory are rejected. Mechanical inspection techniques such as peel and burst testing provide more accurate conclusions on seal integrity than visual inspection alone.

The peel test is preferable to evaluate seal integrity and strength, but to enable a reliable comparison be made of the quality within a single production run it is critical to always break the seal at the same angle of the blister with respect to lidding material and at the same speed.

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EXTRUSION

IT’S A WRAP V

istaMed provides a range of technical extrusion solutions to deliver the optimum jacketed component for minimally invasive delivery or access device.

Metal materials such as coils, hypotubes, wire and even polymer materials can be coated with a range of thermoplastic materials. VistaMed can jacket discrete lengths, as well as provide continuous jacketing. The discrete lengths can have a tapered OD or have a constant OD whereas the continuous jacketing process will have a constant OD. Over jacketing extrusion allows for the application of an outer layer of plastic onto an existing hypotube, coil, wire, or plastic material.

Dwain Tarmey, Vistamed discusses the jacketing of hypotubes and coils for the medical device industry

The process involves a system that will pick and feed the metal parts through the extrusion die head. Prior to entering the die head the metal parts are exposed to heat to promote adhesion to the substrate. Preheating of the metal parts prevents stresses that may occur in the jacket

due to premature chilling of hot plastic from the relatively cold metal part. In the case of small metal parts, this can be accomplished by using a low-voltage resistance applied between two properly insulated metallic rolls placed just before the metal part goes into the crosshead. When using larger diameter metal parts and for secondary jacketing operations, the preheating can be done with either a gas flame or an IR preheating tunnel.

Over the years several methods were taken to straighten wire prior to entering the die head. The two widely used methods are the ‘roll’ style straightening method and the ‘rotary’ style straightening method. The rotary method is the best way to straighten wire but it is very expensive to implement and it will be the slowest method. In the case of the roll straightening method, the wire is forced to navigate a course around roll bearings. The wire is bent past its elastic point and then redirected to a straightened state. With the rotary style the straightening rolls are rotated around the wire as it is pulled through the device. The rotational speed and direction of the rolls as well as the feed speed

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EXTRUSION

and tension value applied to the wire must all be carefully controlled to obtain good results. Roll straighteners, on the other hand, can be configured with multiple planes that can produce the same results of a rotary straightener but are less expensive, easy to set up and, depending on bearing selection, can be operated at speeds into the thousands of feet per minute. Some general considerations to be taken:  The wire should travel in as straight a line as possible when being ‘paid off’ from the spool, coil, or reel and though the straightening device.  As the wire tensile value approaches 300 ksi a ‘roll’ style straightening device is less effective.  The wire should always be ‘pulled’ through the straightening device with as even a back tension allowed.  The pulling force applied should be as consistent as possible.

The most critical part of the basic extruder is the screw and its design. The standard metering screw was for many years the standard screw for jacketing extrusion.

This screw has a very rapid transition which takes place within 1/4 flight of the screw. It has a deep feed section which conveys the pellets and partial melt to the metering zone. Standard design calls for feed section to be 3/4 of the total screw length, with the remaining 1/4 serving as the metering section. The metering section is the most critical area of the screw since it acts as a pump and is also the region where shear is applied to the material to prepare a homogenous melt. It is recommended that the screw have a long, shallow metering section to improve the homogenizing action.

The crosshead serves as the transition piece between the extruder and the die and supports the guider tip and die. It provides a flow path for the melt as it leaves the extruder and turns in the direction of wire travel. The conventional crosshead for wire jacketing is set at 90 degrees to the extruder. Some newer designs set the crosshead at 30 degrees. The claims for this later design are more streamlined flow and less chance for the material to hang up and degrade. Whichever head is used, the passage should be streamlined and polished.

There are two different types of die tooling used for coating metal parts, (1) jacket coating and (2) pressure coating. In jacket coating tooling, the polymer melt does not touch the inner metal part until immediately before the die lips. In pressure coating, the melt contacts the inner metal part long before it reaches the die lips; this is done at high pressures to ensure good adhesion between the two materials. If intimate contact or adhesion is required between the new layer and existing wire, pressure tooling is used. If adhesion is not desired/necessary, jacketing tooling is used instead.

All thermoplastic covered metal parts are cooled after exiting the die head by either passing through a water tank or through an air wipe. Sufficient cooling time is required to allow cooling of the coated product without distortion of the jacketing.

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3D PRINTING

THE PRINTED WORD T

educate the doctors. Installed hree-dimensional printing SYS Systems in 2014, the Objet500 Connex3 has accomplished many outlines some colour, multi-material 3D printer victories in the medical of Stratasys’ can create full-sized models of world, making it an asset to the internal organs eliminating errors industry by changing lives every most impressive day. Both FDM-based and polyJet examples where 3D and misreading of traditional operation plans based on 2D CT technology are frequently used printing has helped and MRI scans. Not only does in the medical field and the more the medical sector this drastically reduce operation we use 3D printing technology to time, but the 3D printed models advance medical sciences, the can also be used as a tool of more life-changing the results communication between doctor and patient, become. The following examples are created allowing them to fully understand the operation using Stratasys 3D printing systems. Here are just a few medical applications, picked by process and procedure/ SYS Systems, where additive manufacturing has been used to save lives and improve quality The 3D model offers a greater insight of the problem, with its multi-colour and multiof life across the world. material properties it can illustrate problems that 2D scans may not. Using bio-texture 1. Anatomical prototypes modelling allows doctors to replicate the organ in materials that can be used to simulate Kobe University Hospital in Japan has surgical procedures. Doctors and students can incorporated 3D printing technology into its study the organ model, identify the appropriate medical approach by producing model replicas treatments, and determine the best surgical of patient’s organs in order to save lives and method.

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Medical trainees at Kobe University Graduate School of Medicine reap the benefits of this revolutionary techno-medical approach through using the models to practice resecting and stitching organs on surgical navigation systems, allowing them to harness real-world surgical techniques confidently. The Objet500 Connex3 offers more than just freedom of design, material diversity in colour, strength and durability, it offers the chance to change and save lives around the world. And as a result 3D printing technology can offer medicine a clearer perspective prior to operation reducing time, risk and error, thus extending the technomedical boundary further than ever before.

The same method was used in saving Mia Gonzalez’s life in Miami, when she arrived at Nicklaus Children’s Hospital having been misdiagnosed with asthma. The doctors there created an anatomically precise 3D model of her heart, discovering a structural heart defect in which a complete vascular ring was wrapped around her oesophagus, resulting in difficulty breathing and struggling to swallow. 3D printing can be used not only to determine the course of action in surgery but can also be used to eradicate medical anomalies. Having an exact replica of Mia’s heart helped the surgical team to visualise the operation process before it was executed and thus, with the use of a Connex3 machine, doctors were able to perform the operation with confidence.

2. Army training aids Where life-saving skills are imperative, training is vital. It is argued that traditional airway trainer manikins do not closely replicate the human anatomy and therefore cannot prepare medical personnel adequately in any field for life-saving procedures. The University of Minnesota Medical School, in a US Army funded study, is developing anatomically accurate airway trainers to improve training for medical emergencies.

Preparing army medical personnel with the best possibly training in order to save more lives.

To do this, firstly the university obtained MRI and computed tomography scans of human airways, taking data from evaluating and redefining their findings in order to generate CAD files. Then using the Stratasys Fortus 250mc 3D printer they were able to build a skeletal structure model, including the skull and jaws. Moulds were then

created to generate soft tissue models out of silicone rubber. They then used the Objet350 Connex3 machine, for its capabilities in multimaterial printing, to produce a realistic replica of the cervical spine.

As a result the 3D printed manikin prototypes, delivered to the US Army research laboratory office in Orlando, closely simulated live human anatomies in geometry and materials, which closely simulated human tissue. The 3D models provide an accurate representation of physical human characteristics, which could aid in future life-saving training due to their physical properties being as realistic as possible without being human. This means more lives can be saved by learning with these prototypes that any other model of air trainer. Not only will these 3D prototypes eliminate inadequate emergency personnel training by providing a much more realistic manikin, but they will also help to shape the approach toward medical emergencies in the future.

Training ground: The University of Minnesota Medical School, in a US Army funded study, is developing anatomically accurate airway trainers to improve training for medical emergencies

3. Prosthetic limbs Restoring or improving an individual’s quality of life is another way three-dimensional printing can be beneficial. Most procedures and solutions to medical anomalies or injuries including lost limbs, fractured bones and missing body parts will cost a fortune to resolve. That’s what sixyear-old Alex Pring’s mother thought when he was born without a lower right arm. Alyson Pring discovered Enabling the Future, a global volunteer community dedicated to helping children with limb deficiencies by providing 3D printed prosthetic limbs.

Through Enabling the Future, Albert Manero, a PhD student in mechanical engineering at the University of Central Florida, offered his help by designing a highly functional replacement limb for Alex at a much lower cost. Manero and his team set about using the FDM-based Dimension Elite 3D printer to prototype using ABSplus material, for strength and functionality. With the Dimension 3D printer this process took just eight weeks. Additionally the final prototype boasts an electromyography sensor inside the arm’s shell, coupled with a microcontroller, allowing Alex to open and close the printed hand by flexing his bicep. While Velcro straps secure his arm into a socket with a diabetic sock, allowing movement and breathability with minimal risk of skin abrasions.

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24/03/2016 09:33

3D PRINTING

Another dimension T

he new stem cell containing bio ink allows 3D printing of living tissue, known as bio-printing.

Scientists at the University of Bristol have developed a new kind of polymer bio-ink, which could eventually allow the production of complex tissues for surgical implants

The new bio-ink contains two different polymer components: a natural polymer extracted from seaweed and a sacrificial synthetic polymer used in the medical industry, and both had a role to play. The synthetic polymer causes the bio-ink to change from liquid to solid when the temperature is raised, and the seaweed polymer provides structural support when the cell nutrients are introduced.

Lead researcher Dr Adam Perriman, from the School of Cellular and Molecular Medicine, said: “Designing the new bioink was extremely challenging. You need a material that is printable, strong enough to maintain its shape when immersed in nutrients, and that is not harmful to the cells.

We managed to do this, but there was a lot of trial and error before we cracked the final formulation.”

An artist’s impression of bioprinting in action. It’s a rapidly emerging technique for the building of living 3D tissue constructs. Credit University of Bristol

“The special bio-ink formulation was extruded from a retrofitted benchtop 3D printer, as a liquid that transformed to a gel at 37 C, which allowed construction of complex living 3D architectures.”

leaving only the stem cells and the natural seaweed polymer. This, in turn, created microscopic pores in the structure, which provided more effective nutrient access for the stem cells.

The team was able to differentiate the stem cells into osteoblasts – a cell that secretes the substance of bone – and chondrocytes – cells that have secreted the matrix of cartilage and become embedded in it – to engineer 3D printed tissue structures over five weeks, including a full-size tracheal cartilage ring.

The team’s findings could eventually lead to the ability to print complex tissues using the patient’s own stem cells for surgical bone or cartilage implants, which in turn could used in knee and hip surgeries.

Dr Perriman said: “What was really astonishing for us was when the cell nutrients were introduced, the synthetic polymer was completely expelled from the 3D structure

Paper: ‘3D Bioprinting Using a Templated Porous Bioink’ by James Armstrong, Madeline Burke, Benjamin Carter, Sean Davis, and Adam Perriman in Advanced Healthcare Materials.

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Bruce Willis and Milla Jovovich get hands on with medical 3D printing Copyright: Featureflash Photo Agency

MEDTECH at the movies

When sci-fi movies predict the future of medicine: the story of how one of the most memorable and futuristic scenes in The Fifth Element has already become reality

Who could forget 1997’s The Fifth Element starring Bruce Willis and Milla Jovovich? Lauded by critics, and loathed by some, the film is nonetheless a cult classic.

Its director, Luc Besson, is known for his outlandish style and tongue-in-cheek humour, with film like Leon and Lucy both telling equally colourful and implausible tales.

THE FIFTH ELEMENT

Interestingly, Lucy also touches on themes of futuristic medicine, exploring the idea of nootropic drugs – drugs that in the future, Besson posits, could see us reach far greater heights by enhancing our cognitive abilities.

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But back now to The Fifth Element.

It all begins in 1914, when the Mondoshawans, an alien species, travel to an Egyptian temple to retrieve a weapon capable of defeating a great evil that appears every 5,000 years and threatens humanity.

The weapon consists of four stones which represent the four elements – as well as a fifth element , a sarcophagus containing a human body, which allegedly combines the power of the other four elements into a light capable of defeating the evil. The aliens pledge to return with the weapon in time to stop the great evil when it returns.

Next, the film jumps ahead to 2263, and, you’ve guessed it, the great evil is back. Time to return that fifth element now please Mondoshawans. Hurry!

Unfortunately, as the Mondoshawans are en route to Earth they are ambushed

by Mangalores, an enemy race tasked with acquiring the weapon.

The Mondoshawans’ spacecraft is destroyed, but the stones are not on board. However the fifth element – the body – is on board, and is all but destroyed, save for one hand.

Scientists take the hand to a lab in New York and use it to reconstruct Leeloo, a humanoid woman. Does this sound familiar, medtech fans?

More on that in a moment.

Leeloo escaped the lab and jumps into the flying New York yellow taxi (perhaps the silliest feature of this movie) of Korben Dallas (Willis). It turns out she’s in luck – Dallas is a former major in the special forces.

The two team up in an effort to beat their enemies to the post and retrieve the other four elements – and if we tell you anymore than that, it’ll spoil the grand finale!

So let’s head back to that New York laboratory. The process involved in reconstructing the body bears an uncanny resemblance to additive manufacturing – or 3D printing. Starting with the hand, the machine rebuilds the human layer by layer, finishing with the brain.

Once that’s done, one of the scientists announces: “Ten second to ultraviolet protection”.

This, it turns out, is the process of re-growing the skin.

Dated graphics aside (don’t forget, this film came out in 1997), it’s an impressive and immersive sequence that leaves the viewer itching to see the finished result.

But recent developments prove that Besson’s vision is not at all far-fetched in 2016. Indeed at the current rate of progress, we might not have to wait till 2263 to be able to re-create something similar.

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Earlier this year, using a custom-designed 3D printer, regenerative medicine scientists at Wake Forest Baptist Medical Center proved that it is feasible to use bioplastic technology to print living tissue structures to replace injured or diseased body parts.

The system deposits both biodegradable, plastic-like materials to form the tissue “shape” and water-based gels that contain the cells. In addition, a strong, temporary outer structure is formed. The printing process does not harm the cells.

Reporting in Nature Biotechnology, the scientists said they printed ear, bone and muscle structures.

When implanted in animals, the structures matured into functional tissue and developed a system of blood vessels. Most importantly, these early results indicate that the structures have the right size, strength and function for use in humans.

“This novel tissue and organ printer is an important advance in our quest to make replacement tissue for patients,” said Anthony Atala, director of the Wake Forest Institute for Regenerative Medicine (WFIRM) and senior author on the study. “It can fabricate stable, human-scale tissue of any shape.

With further development, this technology could potentially be used to print living tissue and organ structures for surgical implantation.”

However, medtech is still some way off Luc Besson’s imagined technology in The Fifth Element.

It’s true that the precision of 3D printing makes it a promising method for replicating the body’s complex tissues and organs. But current printers based on jetting, extrusion and laser-induced forward transfer cannot produce structures with sufficient size or strength to implant in the body, say the scientists.

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