MPN EU Issue 29 by MPN Magazine

MEDICAL PLASTICS news

What lies ahead for medical plastics Micro-moulding expertise Pharmapack 2016 – the trends

MADE TO INNOVATE Borealis in depth

ISSUE 28

January - February 2016

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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.

INNOVA NETWORKI EDUCATION

CONFERENCE · EXHIBITION · AWARDS

VISIT US AT STAND 616 10 & 11 FEBRUARY 2016

PARIS EXPO, PORTE DE VERSAILLES

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

CONTENTS January - February 2016, Issue 28

Regulars

Features

5 Comment We’re in it together says Lu Rahman

19 Tipped for success Industry insiders reveal their predictions for 2016

7 News analysis A technology to end fingerpricks?

25 Cause for thought How 3D printing is helping with brain aneurysm treatment

8 Digital spy 10 News analysis Chinaplas in focus 13 News profile Pharmapack in the spotlight

26 Picking a winner Modern Plastics explains how to choose the right medical plastic

14 Speech therapy Featuring Nelipak

29 It’s the little things… MTD explains how micromoulding is shaping drug delivery

16 Cover Story Borealis talks secrets of success

35 Keep on moving Then latest orthopaedic developments

37 Compound interest Teknor Apex Company discuss the challenges in compounding medical polymers 40 Building growth Sterilisation specialist, Steris AST, reveals investment plans 43 Do wearables hold the key for medical device adhesives? Techsil explains

46 Beady Eye Jason TenBrink, Encoris talks medical modelling

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Brilliant performance | ENGEL medical

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

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

CREDITS group editor | lu rahman deputy group editor| dave gray

EDITOR’S

comment

editorial assisstant | emily hughes advertising | mandy o’brien 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 © 2015 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

WE’RE IN IT TOGETHER I love life sciences. And working across the media of three branches of the sector – medical devices, digital health and pharmaceuticals – it’s hard not to be excited by what seem like daily developments in these markets that push the realms of possibility further and further. What I also love is the fact that a development in one area of life science has a strong and positive effect on innovation in the others. The digital health industry is one example of this. With the fitness arm of this taking the lead in the early stages, opportunities for the medical device market were somewhat overshadowed. A year on from the launch of our very own Digitalhealthage.com and the market for device makers, materials suppliers and technology experts is flourishing. We’ve seen the growth of wearables for those with long-term conditions such as diabetes, as the benefits to both patient and healthcare professional have become apparent to the wider industry. From here, the medical plastics sector, the connected technology industry and markets such as medical adhesives, are recognising the positive impact the growth in digital health is having

on the device sector as a whole. This is something that adhesives expert Techsil has recognised and indeed, discusses in this issue. With many devices currently in design stage and not due to hit the market until 2020, there is longevity and opportunity to be had. Elsewhere another life science market is creating a ripple effect, is personalised medicine. As patientspecific drug formulations become increasingly prevalent, it is likely we’ll see a shift in the type of drug delivery device used as a more personal, bespoke product will be required. It’s here that 3D printing looks likely to steal a march for the production of devices that allow for tailored drug formulations. There is much work to be done in this field regarding material selection and design but the future looks exciting for those involved and what’s even more interesting is that the rise in personalised medicine may be the catalyst for turning the way treatment works on its head. Diagnosis will lead to a tailor-made drug and the device will be made on demand, near to point-of-care. It’s a huge step forward and one which, like the digital health industry is all the more stronger thanks to the shot in the arm that connectivity between all life science sectors creates.

“

A year on from the launch of our very own Digitalhealthage. com and the market for device makers, materials suppliers and technology experts is flourishing.

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

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

Could this technology mean the end of traditional glucose monitors?

hat could apparently, be the future for diabetics thanks to the technology being developed by Kyungsuk Yum, assistant professor in the Materials Science and Engineering Department at The University of Texas Texas at Arlington.

University of at Arlington recently posed the question ‘what if a diabetic never had to prick a finger to monitor his or her blood-glucose levels and instead could rely on an internal, nanoscale device to analyse blood continuously and transmit readings to a hand-held scanner?’

Backed by a $100,000 grant, Yum has created an injectable, nearinfrared optical biosensor nanotube that can read someone’s blood glucose constantly while an optical glucose scanner can access the data collected by nanotube. “Continuous blood glucose monitoring is essential in every diabetic’s life,” Yum said. “This device could unlock continuous information vital to a diabetic’s quality of life.”

According to estimates by the American Diabetes Association more than 29 million people live with diabetes in the United States. That’s nearly 10% of the population. According to the World Health Organization, about 371 million worldwide have the disease.

diabetes and improve the quality of life for people with diabetes.” Early research on single-walled carbon nanotubebased optical biosensing technology was published in Nature Nanotechnology, Journal of the American Chemical Society, Angewandte Chemie and ACS Nano.

“ This device

could unlock continuous information vital to a diabetic’s quality of life.

Yum’s work in this field came about through his desire to help people with diabetes. On the University of Texas at Arlington website he said: “It is a huge societal problem…I believe this nanotube sensing technology has that potential and could potentially provide a better way to manage

Current diabetes technology offers patients two options. One requires a tube to be inserted through the abdomen for use with a continuous glucose monitoring system. The more common method requires a finger prick that provides blood for an external system called a glucometer. As the sensor system reads glucose levels in the patient’s tissue, this can be seen as a drawback as it isn’t as accurate as a blood reading. The continuous glucose-monitoring sensor also needs to be calibrated multiple times a day and changed every five to seven days. The drawback to the glucometer is that it requires painful finger pricks throughout the day.

Khosrow Behbehani, dean of the UTA College of Engineering, said Yum’s work is representative of biomedical innovation that will improve health and the human condition: “It’s compelling work that could improve the way diabetics live every day,” Behbehani said. “When research touches lives in such a way, it can dramatically affect the health care of millions of people.”

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DIGITAL

spy APPY TALKING

THIS ISSUE STEPHEN KITSON, CEO, FOLIUM OPTICS SELECTS HIS FAVOURITE APPS

DIGITAL BITESIZE

MD&M West – KNOWLEDGE SHARE

Any.DO This is a simple but powerful task manager. Tasks are sorted into one of four lists – tasks to be done today, tomorrow, upcoming or someday. It’s easy to move tasks between lists and to assign them to other people. It also synchronises with a browser version. This is my favourite to do app – essential for organising my day Drafts A simple writing app that allows you to quickly capture text. It synchronises across devices so you can carry on writing wherever and whenever you need to. Once your text is complete, Drafts has a comprehensive list of options for sharing the output. It’s rapidly become my default app for note taking – I used it to write this article! iThoughts A mind-mapping app for iOS, this app is simple to use and helps you capture your thoughts quickly and clearly. It includes a huge list of options for exporting the mind maps so that you can share the results easily. Munzee We like to get outside and go for walks. Munzee is a great way to add a bit of extra interest for the family. It’s a global scavenger hunt - it uses your phone’s GPS to locate tokens hidden by other munzee players. When you find it you scan the QR code on the token to claim your points. Very addictive. Machinarium My son and I love playing point and click adventure games together on the iPad. Our all time favourite is Machinarium. It has beautiful hand drawn graphics and challenging problems to solve, together with a brilliant sense of humour. An excellent way to escape from work for a bit. hardware. I would say this is a must have for many engineers and developers.

At this year’s MD&M West conference some of the latest medical technology will be presented (Anaheim, February 9-11). A full-day conference track, New Product Development Technologies and NexGen Applications, explores how technological developments are presenting opportunities for medical innovation and new forms of treatment—bridging the gap between electronics and biology.

The Doctor is In - Here’s What Physicians Really Think About the Future of Medical Innovation, will discuss how emerging technologies will improve population health and lead to medical breakthroughs in the next two to five years. The panelists will discuss the new need for medical devices within specific treatment areas and how connected devices enhance healthcare overall Dr. Kwanoh Kim, a postdoctoral fellow at the University of Texas at Austin’s Cockrell School of Engineering will present a case study, Nanorobots: A Bottoms-Up Approach, about how miniscule robots can seek out problem cells and provide targeted treatment inside a patient’s body. Dr Kim will examine the growing trend towards using nanoparticles to carry molecules or drugs from a medical device and how coupling nanometers with advanced medical equipment can create multifunctional biomedical technology

DIGITAL UPDATE

STERILISATION CONFERENCE

terilisation specialist, Synergy Health, now part of Steris, will be hosting a conference focusing on key issues relating to terminal sterilisation and aseptic processing on 1 March 2016 in Venlo, The Netherlands.  The event, Guiding You through the Challenges and Identifying Solutions to Deliver Your Product to Market, aims to enhance knowledge, allow attendees to engage with industry experts and increase understanding

Contact education@synergyhealthplc.com

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DIGITAL SPY

DIGITAL NEWS

Maths app

helps manage polymer recipes

cientists at the National Institute of Standards and Technology (NIST) have made making a polymer recipe a more palatable job, thanks to a new app. The team has likened this to ‘baking a special cake, one in which the shape of each mote of spice mixed into the batter can have a profound effect on your dessert’s colour, its taste, its texture on the tongue’. While polymers play a number of roles in daily life they lack many properties that would make them even more useful. A way around these limitations is to mix in other ingredients that have the right properties. Polymers conduct electricity poorly, for example, but adding carbon nanotubes (CNTs) or graphene sheets forms a strong, lightweight ‘nanocomposite’ whose

Graphene has hit the headlines frequently over recent years. In the life science sector it is compatible with a range of biomedical applications such as drug delivery. It is thought that graphene could play a significant role in the future of medical implants thanks to its biocompatibility and mechanical strength. This may prove beneficial for composite bio-materials and its electrical conductivity is being explored in this area. Work being carried out at the Michigan Technological University is looking at 3D printed nerve replacement nerves using 3D bioprinting methods. A polymer material has been created that can act as a scaffold for growing these tissues and graphene is being used to conduct electricity.

Sticky situation…

Prehistoric ‘goo’ coating improves medical devices and implants

SIRO has developed an innovative ‘goo’ coating that could be used to improve medical devices and implants.

Dr Richard Evans, CSIRO said: “The human body is a complex system so there is a lot to consider when implanting artificial parts. “Reducing the likelihood of infection and ensuring the body doesn’t reject implants are on-going medical challenges. “That’s why coatings on these implants are needed to help them to do their job.

POINT

electrical conductivity can be more than a million times higher.

DIGITAL BREAKTHROUGH

According to the company, molecules from this primordial goo – known as prebiotic compounds – can be traced back billions of years. Now researchers in Australia have uncovered a way to use these molecules to help with medical implants like bone replacements, catheters and pacemakers every year.

talking

“We wanted to use these prehistoric molecules, which are believed to have been the source of all life evolving on earth, to see if we could apply the chemistry in a practical way.” This bio-friendly coating allows cells to grow and colonise quickly and could be used a medical device coating to improve performance and acceptance by the body. “The non-toxic coating is adhesive and will coat almost any material making its potential biomedical applications really broad,” Dr Evans said.

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In a capsule… Capsule endoscopy means many gastrointestinal diseases can be detected and Covestro’s polycarbonate has a key role to play What is capsule endoscopy? The introduction of this procedure has resulted in great progress in the detection of gastrointestinal diseases and is an important complement to gastroscopy and colonoscopy. A patient swallows a small capsule, which is transported like food through the digestive tract while delivering images of the stomach and intestinal walls. Doctors store the images on external image recorders and analyse them for diagnosis. Why are materials important? Because patients ingest the capsules, the materials used must meet stringent requirements. For the capsule shell, Shenyang Shangxian uses a special grade of polycarbonate Makrolon from Covestro. The material is biocompatible and impervious to both stomach acid and the alkaline intestinal flora. It is also mechanically strong and safe, ensuring a trouble-free examination. Endoscopy as convenient as swallowing a pill “Capsule endoscopes are composed of a miniature camera, digital processor system, and a transceiver for wireless data transmission,” said Sun Yufeng, general manager of Shenyang Shangxian Technology. “They are taken with water, just like medicine. The materials therefore have to be safe and corrosion-resistant, while also allowing for a large filming angle for the camera. Doctors also have stringent requirements for image quality. Covestro’s polycarbonate is perfectly suited for this application.” The plastic is highly transparent, enabling clear, wellresolved images. It also offers ample design freedom, facilitating a large filming angle for the camera so that a wide field of view can be covered. These advantages make an important contribution toward eliminating uncertainties in the diagnosis of gastrointestinal diseases and spare the patients discomfort during the examination. Tony Tong, Covestro marketing expert for polycarbonates in China said: “Covestro develops solutions for the utilisation of polycarbonates in medical technology, and there are many applications here. We will continue to support companies in this sector in China with their use of polycarbonate. 9

NEWS ANALYSIS

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The 2nd Medical Plastics Conference will be held alongside the show on where international experts will talk about the latest topics in the industry

CHINAPLAS –

polymers transforming healthcare

olymer technology plays a vital role in the medical products sector. At this year’s Chinaplas these innovations will be showcased highlighting the advanced materials and processing technologies used in today’s medical year’s products.

This Chinaplas on Biocompatibility as a driving force 25-28 April, 2016 at Shanghai New Materials that are implanted into the body or that are used in applications where they International come into direct contact with human tissue Expo Centre will are subjected to rigorous testing to ensure they do not cause any adverse reactions. feature a plethora Polymers such as liquid silicone rubber, of polymer thermoplastic elastomers and various biopolymers are proving themselves to be technologies aimed up to the task. at improving Firms such as Germany’s Gerresheimer Group are turning to cyclic olefin polymers today’s healthcare (COPs) to replace glass in a number of environment vials and syringes. This is due in part to the rise in popularity of bio-based pharmaceuticals. COP, which is more chemically inert than glass, is a desirable primary package that offers excellent barrier properties and is less likely to break. Meanwhile, in hip-replacement procedures, carbonfibre-reinforced PEEK (polyetheretherketone) – a high-strength, wear-resistant, biocompatible polymer composite – is being used to form a high-tech hip socket, mostly replacing metal.

Additive manufacturing adds a new dimension Additive manufacturing (AM), or 3D printing is revolutionising the medical sector. Using a variety of materials – including a growing number of plastic resins – doctors now can do things never before possible. Using 3D printing, they now can replicate damaged sections of the human skull, or other body parts such as hip and knee, dental crowns, and manufacture biocompatible and perfectly customised pieces that can be used to reconstruct the damaged area. 3D printed anatomical models have been helping surgeons practicing and achieving better surgical results. 3D printed drugs are becoming popular to produce personalised medication for more targeted therapy. Additive manufacturing market in medical application is expanding rapidly. Currently $83.7 million worth of material is being consumed annually in medical sector alone; while the selling of printing machine will be doubled from $24-million in 2014 to $56-million by 2020. These technologies just scratch the surface when it comes to the variety of materials and equipment that are reshaping today’s dynamic medical sector, says the organiser of the event. The 2nd Medical Plastics Conference will be held alongside the show on where international experts will talk about the latest topics in the industry covering 3D printing, advanced medical grade polymers, pharmaceutical packaging and technology breakthroughs. The conference provides a focused networking platform for material suppliers, processing suppliers and medical products suppliers to exchange insights and ideas with one another.

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www.netstal.com

Outstanding quality High returns 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.

Engineering Excellence

Bormed™ Because we care

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 Pharmapack Europe in Paris from February 10-11, stand 2015, hall 5.2.

PHARMPACK

A la mode T

his year’s Pharmapack Europe– which takes place on 10-11 February at Paris Expo Porte de Versailles – has identified several key trends that it says pharma and companies operating in drug delivery and packaging, must address in 2016. The annual event will take in Paris on 10-11 February where industry analysts, executives and companies will gather to learn and discuss the latest issues affecting the industry.

A key issue for 2016 will be the ongoing implementation of track and trace technologies, and the impending European falsified medicines directive. Experts will discuss the implications of the pan-European authentication scheme, its impact on Updates on the latest contract manufacturers, OEMs and market trends in drug pharma companies. Speakers will delivery and packaging include Craig Stobie, Domino; Romulo will be on offer at this Leon, Mettler Toledo PCE; Michel Bullen, Optel Vision; Rick Seibert, Sharp year’s Pharmapack Packaging Solutions and Michael Gaub, Pester. The European standard EN 16679, has recently come into effect and provides guidance for the application, use and checking of tamper verification features to the packaging of medicinal products. By 2018, all prescription medicine will be required to include a tamper verification feature (TVF). Pharma is now at a crossroads, say the organisers of the event and manufacturers across Europe have to decide which TVF to choose before the looming deadline.

Human factors engineering

Combination products will also be a key area for 2016, with the integration of human factors engineering (HFE), design for manufacturing (DFM) and design for assembly (DFA) seen as the foundations for the development of this product class. There will be an emergence of smaller and smarter combination products that will speed-up time to market by examining the manufacturing scale-up strategy, concurrent with the development process. Technologies and packaging that can improve patient adherence will remain a key growth area and several sessions will run at Pharmapack across the design process for patient friendly packs and how new innovations alongside social media are helping drive crucial competitive advantages. In oral solids, the discussion for the last 30 years has been rigid versus flexible solutions – essentially bottles versus blisters. But in 2016, companies will be seeking better packaging options for pharmaceutical doses.

Communication is key

Moreover, the drive for packaging to communicate with patient and healthcare professionals is growing rapidly – whether driven by regulatory agencies (serialisation and traceability) or consumer groups. The next hotbed of potential innovations is set to be flexible packaging for variable dosage forms, in line with the rise in personalised medicine. Ultimately, we may see packaging that has the scope to communicate, or be involved more directly, in the relationship between consumer and physician. But who will be the industry trailblazers and can disruptive players like Apple and Google help to build new eco-systems that revolutionise this status quo?

Outsourcing growth

Outsourcing is continuing to accelerate with new prototypes and innovations emerging rapidly from the contract services sector itself. This has huge implications not only in terms of regulation challenges and changes but also in terms of skills migration from pharma into the supply chain. The conference will conclude with a roundtable on ‘emerging technologies and innovation forecast’. Steven Kaufman, global business development lead, Bespak, commented: “Pharmapack Europe provides an excellent opportunity for attendees and exhibitors to engage with current and prospective business partners in packaging and drug delivery. It’s a vital reference point of new business strategies, thought leadership, and innovation that will shape the industry over the next year.”

Innovation gallery

The Innovation Gallery at Pharmapack Europe 2016 will showcase the advances in packaging intelligence – such as new material, primary and secondary packaging, delivery, labelling, leaflets, anti-counterfeiting technologies, and traceability – that will underpin the next generation of delivery technologies in 2016 and beyond. “The year ahead is extremely exciting for the pharma packaging and drug delivery industry, with new strategies across patient packaging and combination products, as well as outsourcing helping to bring drugs to market faster. Our conference platform and innovation galleries have identified the crucial breakthroughs that will revolutionise not only how pharma and supply partners work together, but also how these technologies will be essential in transforming the patient experience. In the last few years, packaging and delivery have become an even more essential part of a drug’s regulatory approval process, adherence and efficacy – especially as the use of personalised care and cost effective generics increase. I would encourage anyone looking to stay ahead of market trends and meet new innovative partners to attend Pharmapack,” said Anne Schumacher, event director, Pharmapack.

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Q&A

VOCAL

exercise

What excites you about this industry?

s you can guess, our passion is A packaging! We are excited by new opportunities we are pioneering to bring change to all parts of the product lifecycle and how improve the way users interact with packaging.

What does Nelipak do?

Q&A

Nelipak Healthcare Packaging is a full-service global provider of custom thermoformed packaging that provides superior protection for medical devices and pharmaceuticals. We fulfil customers’ healthcare packaging needs including: concept, design, development, prototype and production tooling, validation, and commercial product output, including AVS and sealing machines.

We have a team of healthcare-focused designers and engineers who apply a combination of freehand design capabilities with technology including sketching, solid works simulation software, 3D printing to support our customers in developing packaging that offers an improved level of user experience.

How would you sum up your company?

N elipak is a strategic packaging partner that’s 100% focused on the healthcare market. We offer medical trays and blisters, surgical procedure trays, pharmaceutical handling trays, custom built sealing machines, total packaging solutions and other value added services. As well as using bestin-class manufacturing processes, we apply a combination of freehand design capabilities and technology to help our customers develop better products for end-user needs and to proactively innovate to industry trends.

The ability to proactively innovate even at the earliest stages of development by applying a thorough understanding of industry trends and end-user needs and challenges helps create optimised packaging that can better serve its purpose, reduce waste and even minimise risk factors when used in the operating room.

What do you see happening in the industry in the next 12 months? e’re seeing more and more pharma W and medtech companies merging to deliver more targeted treatments for a range of conditions. As a result, I think we’ll continue to see an increase in drug combination devices over the next 12 months and beyond.

Name a business achievement you are most proud of.

Our global presence means our team is highly accessible and can provide innovation and quality to our customers wherever they are located. We have facilities in the US, the Netherlands, Ireland and Costa Rica with more than 500 employees worldwide. We are also totally focused on the healthcare market and the needs of medical and pharmaceutical customers. All Nelipak sites are equipped with clean oom capabilities and certified to ISO 13485 standards.

Which medical plastic device do you wish you had invented and why?

I wish we had invented the coronary stent. Personally, I know so many people who would not be here right now if it were not for this technology. We take them for granted today but previous methods of treatment were invasive to the patient and required longer recovery time.

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COVER STORY

Russell Tew, New Business Development Marketing, Healthcare, Borealis, provides an insight in to the company and its expertise

Made to

innovate What excites you about the industry at the moment?

In the healthcare industry, there is always something changing or developing which makes it a challenge and therefore very exciting. At Borealis, we strive to be a leading innovator in the industry and to always provide our customers with cutting edge solutions tailored to specific application needs. One of our corporate mottos is Value Creation through Innovation, which is particularly relevant to the ever-changing healthcare industry because it motivates us to stay ahead of the curve while continuously striving to deliver valuable products and services to our customers.

2015 was an important year for Borealis. Which achievements stand out the most for the company? Last year was indeed a big year for Borealis. In 2015, we achieved a record level of profits, which was a proud achievement for us as a company.

In 2015, we achieved a record level of profits, which was a proud achievement for us as a company,’ says Russell Tew, Borealis

For our healthcare business specifically, though, we had our first commercial sales of our soft polypropylene resin, Bormed SB815MO. Officially debuted at the K Fair in 2013, we see this as delivering a step change innovation in softness – it’s the softest PP grade within our Bormed portfolio. The use of the Borealis proprietary Borstar technology enables good transparency without the addition of clarifiers and the material offers advantages for production processes in which terminal sterilisation has become the rate determining step (RDS). When compared with low density polyethylene (LDPE) which can only be steam sterilised up to a maximum of 112°C, the sterilisation cycle with Bormed SB815MO at 121°C may be completed in half the time. What is more, this is achieved with a material that is flexible enough to be easily selfcollapsible without venting, mimicking the performance of LDPE.

Throughout the year we put an increased focus on our Bormed product portfolio, promoting at various events throughout the year. At the beginning of 2015 we also launched new efforts

“

to position our healthcare solutions in the industry, including a microsite dedicated to the pillars of our healthcare product and service offering and to our Bormed portfolio. We also reorganised our polyolefins sales and marketing functions to create a new structure that allows us to focus even more on serving our customers and value chain partners in an effective and efficient way.

What do you see as the key drivers in the medical plastics sector for 2016? In 2016, we believe that we will see an increase in regulations in the healthcare industry regarding medical plastics, which are important to ensure to delivery of a safe and effective product to the end consumer. In line with this development, we will see an increasing need for knowledge about the plastic materials that are used to produce and package medical devices and pharmaceutical products. This is a trend that is also becoming more prevalent in other industries, such as food packaging, cosmetics and other consumer products segments.

With these regulatory changes comes the need for change management on the part of all value chain members to adapt and accommodate to these new requirements. For our part as a plastic raw material supplier, we are aware of the need of increasing engagement to meet these regulations on behalf of our customers and partners, while still delivering on their individual needs for their specific applications.

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In focus: Tew explains how Borealis’ healthcare business will continue its dedication to the industry by further developing and expanding its portfolio of products.

At Borealis, we address these key drivers with the three pillars of our Bormed concept: commitment, servicecand conformance. We are committed to ensuring security of supply for our customers and partners in the short and long term as well as higher stock levels and planning prioritisation. Our dedicated, global team of specialists – from R&D to technical support and sales – will continue their ongoing dialogue with the industry in order to better assess needs and provide the best service, whilst our expanding range of products offers built-in regulatory compliance in conformance with industry requirements, dedicated production and quality control procedures.

What will the company be focussing on this year? In addition to continuing to offer what we believe to be the best in class offer to the healthcare industry, we are looking to expand our portfolio in terms of new products that are being developed in cooperation with our partners as well as extending the Bormed directive to the production of our Plastomers materials. As already mentioned, the Healthcare space is truly dynamic and therefore we are also very vigilant regarding any requirement, through changes in legislation for example, that our customers need. We understand that the Bormed approach needs to be a living concept to fully support the industry and that we cannot just sit back and admire our work to date. This involves an ongoing and active commitment to the industry.

us to keep our finger on the pulse of the industry in different markets as well as promoting our solutions in different regions.

What would you say is Borealis’ unique selling point? Quite simply, we believe that our level of service, and through that, our level of engagement with our customers and partners is how we offer a unique selling point to the industry. We take the time to understand our customers’ needs and challenges, take ownership of them and then translate them into how the chemical industry, ie. polymer producers, can best support them. In short, we have become internal healthcare industry advocates. For example, we participate in bodies such as the MedPharmPlast Europe sector group of European Plastics Converters (EuPC) to understand the upcoming regulatory changes proposed for the healthcare space and provide informed feedback on how these changes can be implemented in a practical way. On the more practical side, we have a programme to provide extractable profiles for our Bormed resins to support our customers’ leachables and extractables studies.

You’re exhibiting at Pharmapack - why is the event important for you? Pharmapack is an ideal event to participate in because it is compact, with all of the major EU healthcare industry players there in one location. Because of the event setup, all exhibitors are relatively equal in terms of stand size and presence, so it makes the whole event more about the discussions and the content of those discussions.

Which other exhibitions will you be attending and why? In addition to Pharmapack, we will be attending CPhI in Barcelona in October as it is the largest healthcare fair in Europe and the largest one Borealis participates in for that business area. Looking more at the Middle East focus, we will attend ArabHealth this month as well as participating in some other events in that region with our joint venture, Borouge. We will also be attending MD&M West in February in the US. This global approach to events allows

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Visit us at

Pharm

apack

10 th -11 th

eb 2016 ANNUAL CONFERENCE Stand F

Concept to Market and Everything in between: Guiding You through the Challenges and Identifying Solutions to Deliver Your Product to Market.

Specifically created for medical device and pharmaceutical companies. Content will address key issues relating to terminal sterilisation and aseptic processing.

Why you SHOULD attend Enhance your knowledge Engage with industry experts and key opinion leaders Increase understanding of current industry standards and regulations Share your experiences

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st March 2016

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education@synergyhealthplc.com

THE YEAR AHEAD

Tipped for success T

he medical plastic device sector is continually seeking improvements to improve the health and well-being of us all. Developments in materials, design and manufacturing processes are key to the success of the sector. In recent technology has been a key focus Some of MPN’s years with increased emphasis on wearable and key contributors connected devices. The move towards self-care and management has had a reveal their patient visible effect on the market such as the drug predictions for delivery sector as manufacturers recognise the need to be part of this ‘smart market’.

industry trends in 2016

This is a vibrant market, keen to explore ways of improving its products and the benefits they offer society. Improved manufacturing processes are always a key focal point as of businesses strive to work more efficiently taking advantage of opportunities and market growth. According to the organisers of this year’s Chinaplas, the global medical products industry has never been more dependent on plastics and rubber suppliers to help its meet today’s healthcare needs. The medical applications incorporating polymers are diverse and numerous, including: drug-delivery systems; sophisticated diagnostic imaging equipment; surgical tools; prostheses and life-maintaining implantable devices; pharmaceutical packaging; various disposables such as tubes, infusion bags, catheters, syringes, and also increasingly, interactive healthcare monitoring. The US trade association Advamed, estimates that the medical device industry is currently worth $120 billion globally.

2016 WWW.MEDICALPLASTICSNEWS.COM

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THE YEAR AHEAD

He cites four major examples:

“

Growing news: According to Christoph Lhota, growth is being driven by the diagnostics market including laboratory products and pointof-care applications. Christoph Lhota

Market share According to Christoph Lhota, vice president Engel, medical, the market for plastic products for medical technologies will grow slightly in 2016. “We also see potential in Europe but it is strongest in North America,” he adds. Lhota says growth is being driven by the diagnostics market including laboratory products and point-of-care applications. In all areas, innovative technologies are preparing the way for new functionalities, more costeffective production and safer patient care.

Keeping it personal

1•

Medication delivery devices such as inhalers and auto-injectors are becoming increasingly intelligent. Thanks to the integration of electronic functions, they network themselves with other systems in order to ensure the unbroken documentation of therapyrelevant information;

2•

In diagnostics, sample vessels are becoming widely used that have functionalised surfaces to either specifically initiate or prevent interaction between the sample and the vessel wall;

3•

Barrier functions are at the focus for pharmaceutical packaging. They pave the way for the further substitution of plastics for glass;

4•

Innovative, highly integrated processing methods help achieve a more costeffective production and therefore make high-quality medical products affordable worldwide. For instance, the needles of injection syringes are overmoulded directly in the mould, not only making the production more efficient but also saving raw material.

Importance of packaging Eric Resnick, president, pharmaceutical delivery systems, proprietary products, West says that in 2016, many drug manufacturers will focus on the development of largemolecule antibodies for new therapeutics and we will see an increased demand for innovative and effective drug packaging and delivery that can accommodate larger doses given over a longer period of time.

Supply and demand: Eric Resnick says that 2016 will see an increased demand for innovative and effective drug packaging and delivery

2016 Thomas Kinisky, president and CEO of Saint-Gobain Performance Plastics says: “Looking forward in 2016, SaintGobain Performance Plastics (PPL) is expecting to see a few trends influencing medical plastic manufacturing.” Kinisky says that firstly we should see an acceleration of cell therapy as it moves on to the development phase.

“We expect personalised medicine to require a higher volume of engineered and customised plastic disposables in the mid-term, as the commercialisation of treatments gains traction.

Saint-Gobain PPL is also making strides in regards to quality/regulatory/validation (QRV) requirements. This comes as the use of plastic-based disposables continues to gain share, particularly in bio-processing. The QRV requirements will continue to increase for the manufacturers of the plastics disposables. End-users will have to demonstrate quality across the supply-chain, so suppliers will have to expand their compliance systems.”

“Additionally, we will see a continued interest in alternatives to glass such as polymer-based systems for drug packaging and delivery systems, especially for biologics, which can be sensitive to glass containers. Since biologics are sensitive drug products, there is a need for ultra-clean packaging components to ensure that there is a low risk of contamination or particulates.

“The connected health movement will drive forward the convergences of digital technologies and drug delivery systems. With that, wearable injector systems for the treatment of chronic conditions will become increasingly popular. This will lead to an increased focus on innovations for new, integrated drug container systems that further aid patient adherence, comfort and safety. In terms of device manufacturing, 3D printing technology will show its disruptive potential, as many industry players will start working to integrate it into the development and manufacturing processes. This in turn will, however, require additional insights and expertise regarding the material and chemical compounds and processes,” he adds.

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THE YEAR AHEAD

2016

Two becomes one: The connected health movement will drive forward the convergences of digital technologies and drug delivery systems says West’s Resnick

Innovation

On the up: Sven Kitzlinger, application technology consulting, medical technology at Arburg, says there will be an increase in the automation of production processes

Automation of production

“In the medical technology segment, we expect an increase in the automation of production processes through the integration of downstream processing steps in the coming year, 2016. There will also be a focus on the use of highspeed machines for the packaging of pharmaceutical products,” explains Sven Kitzlinger, application engineering medical technology at Arburg. “In both cases there are increasing synergies with the packaging department, where we also have a high level of expertise.” One example of the integration of downstream processing steps in a complete turnkey system is the manufacture and packaging of ready-to-use dental drills made from PEEK under cleanroom conditions.

Alan Davies, director of home healthcare for the UK and Ireland at Philips is clear in the trends for the sector. He says: “The NHS is currently experiencing an exponential growth in the demand for non-acute care, with estimates citing that by 2030 just under one-inthree in the UK living with a long-term condition. So it’s exciting that 2016 looks likely to bring with it an increasing number of new innovations that seek to directly address these demands. “From our experiences in the sector, we expect to see more programmes and devices that educate people on health maintenance and these will become increasingly sophisticated to the point of becoming recognised medical devices.”

Trendsetter: Alan Davies, Philips, says that one trend will be innovations that are supported by sophisticated health networks, such as Philips HealthSuite Digital Platform

Davies says that another trend will be innovations that are supported by sophisticated health networks, such as Philips HealthSuite Digital Platform, to facilitate closer collaboration between patients and their care teams. “For those living with long-term conditions, innovative selfcare programmes will offer them tools to better manage their health while remaining independent, by increasing the ease of access to consultations with their health teams from their own home. “While acute services will always be there to care for the very ill, we expect 2016 to offer more examples of how innovation in this space can help to provide healthcare more holistically, help people maintain good health and support those with long-term conditions to live independently,” he adds.

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3D PRINTING

CAUSE FOR THOUGHT S

tratasys has revealed what it is calling a ‘major advance in surgical pre-planning’ led by 3D printed anatomical models. The company has teamed up with the Jacobs Institute (JI), physicians at Kaleida Health’s Gates Vascular Institute Stratasys and and biomedical engineers at the University Jacobs Institute at Buffalo for the design of a revolutionary unveil 3D new approach to repair a complex brain aneurysm. The life-like 3D printed replica printing helps significantly reduced risks associated with with brain this complex surgery and corrected a nearaneurysm fatal condition.

treatment

“We took the image of the aneurysm based on her scans to generate an exact replica of the entire brain vessel anatomy. The Stratasys 3D printed model enabled us to devise a much more optimal means to treat her,” said Dr Adnan Siddiqui, chief medical officer at The Jacobs Institute. According to the Brain Aneurysm Foundation, aneurysms are responsible for nearly 500,000 deaths each year worldwide. Resulting from a weakened area within the artery, which fills with blood and creates extreme pressure, about six million people currently live with the issue still undetected. After experiencing diminished vision and headaches, patient Teresa Flint was referred to the specialists at the Gates Vascular Institute – where she was diagnosed with a life-threatening aneurysm. “Typical treatment options are highly risky, as no two cases are identical and require deep understanding of each patient’s unique vascular anatomy. With the aid of Stratasys’ PolyJet 3D Printing Solutions, surgeons globally are now able to quickly pinpoint affected areas on individual

patients and practice surgeries on realistic anatomical 3D printed models. This is expected to dramatically minimise risks associated with delays and complications stemming from real-time, in-procedure diagnoses,” said Scott Radar, general manager of Medical Solutions at Stratasys. “Our original plan was to treat her aneurysm with a metallic basket – delivered into the area with a tiny tube. After attempting the procedure on the 3D printed replica, we realised it just wasn’t going to work,” noted Siddiqui. “Based on the Stratasys 3D printed model, our team was able to pre-empt potential complications and devise a much more optimal means of treating the aneurysm.” To create a viable surgical solution, JI came together with Ciprian Ionita, a research assistant professor of biomedical engineering and neurosurgery, school of engineering and applied sciences and Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo. Together, they transformed Flint’s CT scan into a single material model to manipulate and test. The life-sized replica was 3D printed using Stratasys flexible TangoPlus polymer material on the Objet Eden260V professional 3D Printer, fully mimicking the feel of human tissue and its vascular structure. Accurately reproducing the aneurysm’s geometry, doctors conducted a range of new testing and simulations to devise potential treatment options. After exploring a handful of approaches on the model in a surgical environment, doctors were able to successfully operate on her actual aneurysm. “By 3D printing models that mimic vascular feel, we can create an approach I don’t think is achievable any other way,” concluded Michael Springer, director of operations and entrepreneurship at The Jacobs Institute.

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HIGH PERFORMANCE POLYMERS

Picking a winner D

evice manufacturers have a number of criteria to consider when selecting plastic materials. Highperformance plastics are the natural choice not just a single reason, but a combination of features and benefits. These plastics should be selected during the design due to their ability to meet the Selecting the process application requirements, quality of the right medical device, productivity and/or save costs.

plastic is a key consideration for device manufacturers. Bing J Carbone, Modern Plastics, offers his expertise on how to choose the right material

As a general family of products, high performance plastics share several demonstrable advantages over ‘traditional’ plastics. In the medical device market, the weight savings of high performance plastics are key, offering a typically reduced weight compared with other materials. Weight is a factor in medical device instrumentation where weight reduction combined with strength is an advantage.

High performance plastics are able to withstand the effect of corrosion of common chemicals, water and a variety of solvents, acids and other corrosive liquids. Also, many performance plastics are highly suitable for repeatable autoclaving. They also have impact resistance advantages – their inherent ability to resist breakage from impact makes them a wise choice in tough applications. Closely linked to impact resistance, products can be designed to absorb impact energy and lessen the shock/vibration transmitted into the supporting device. There are additional advantages to high performance polymers. In cases – like instrumentation – where noise reduction might apply, high performance plastics reduce/eliminate noise generated and have excellent insulation properties. There are also benefits when lubrication is an issue – they can include additives which improve their inherent good-to-excellent wear properties. This is especially true in the class of high performance engineering plastics.

ADDITIONAL ADVANTAGE OF OF HIGH PERFORMANCE POLYMERS • Temperature – Knowing the temperature limits of specific high-performance plastics often plays a critical role in the selection process. • Wear Properties – Closely linked to low friction characteristics, plastics eliminate wear on mating surfaces. • Abrasion resistance – Plastics wear longer and reduce maintenance needs, promote longer run times and can result in improved productivity. • Non-Marking properties – Plastics will not deface the finished product. • Value vs. Price – The cost of the performance plastic is offset by the improved life in use, lower maintenance requirements, reduced wear on mating surfaces, environmental considerations and so forth. • Ease of machining/fabrication – Performance plastics are typically easier to machine than most metals, cause less wear on machine tools, are easier to handle during the machining process, reduce finishing costs, are easily decorated and can exhibit integral color. • Versatility – Performance plastics are available in their natural form and modified (enhanced) forms. They are manufactured in various shapes, sizes and colors and available in FDA and X-ray detectable grades. • Environmentally friendly – Contrary to some misguided popular opinions, performance plastics are green! Performance plastics require far less energy to produce than metals, have a lower carbon footprint, are less costly to ship and many types are recyclable.

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MEDICAL PLASTICS DISTRIBUTORS Plastics distributor that specialise in medical plastics are uncommon but should offer a number of services such as: • Experienced technical sales staff in medical plastics

Selecting performance plastics To make an intelligent material selection for a medical device with a performance plastics there are several questions to ask, especially at the beginning of a project, when the parameters may not be finite or well known. Selecting the ideal performance materials can be challenging. Modern Plastics can assist in the material selection process, provide data and samples as needed to help customers select the best material for their application. There are of course, certain things to consider. For example, do you need to see through it – that is, should the material be transparent? What is the operating temperature? Does it have to have to be chemical or corrosion resistant? We would also consider what the tensile / load requirements are, if any specific characteristics are needed and what the special needs are of the project. If the material needs to meet any certifications such as ISO 1099, we would include that in the selection as well as the planned method of manufacture. On top of this we would look at what is motivating or driving interest and of course, cost considerations come into play.

• Material barcoding – so important to clearly identify materials and trace batch, resin and lot. • Complete material traceability – closely linked to barcoding, but so much more is involved. • 20-year record retention should be the minimum. • Same day, overnight shipping service • Complete material certifications • ISO 9001 AND ISO 13485 compliance. • Non-disclosure agreements should be a common practice. • Environmentally-controlled and monitored storage conditions are essential.

Sterilisation methods also limit choices of potential materials. Many of the devices used in orthopaedic surgery are reused. After surgery, materials are cleaned with a high pH cleaner and then steam sterilised in an autoclave. This combination of heat and water in the form of steam limits the selection of plastic materials to a handful of candidates. There has been a trend recently to make single use devices that can then be handled as revenue generators for the OEM and billed to the patient when used in a surgical procedure. Currently, reusable devices are provided at no cost to the surgeon to support the surgical procedure that places the implant in the body. However, these are not billable items. Thus, with the migration to single use devices increasing, the sterilization method is changing to one in which gamma exposure with the device in package is preferred. Gamma radiation will create changes in the polymer which again captures the eye of the FDA with respect to the validity of the ISO 10993 test performed on raw materials that were not exposed to radiation prior to testing.

Some raw materials ultimately end up in surgical devices that also contain sensitive electronic components. If these are repeated use devices, the sterilisation process needs to be something that can occur at the hospital • Ability to cut-to-size and Sterilisation methods and does not use heat and moisture. Cold other value added services sterilisation employs hydrogen peroxide Sterilisation methods also limit choices of plasma gas at temps of ~120 F. One filter to • Able to distribute plastics potential materials. Many of the devices used in consider for a material selection for a device from several ‘premier’ orthopaedic surgery are reused. After surgery, intended for cold sterilisation is the chemical quality manufacturers. materials are cleaned with a high pH cleaner resistance of the material to hydrogen peroxide. and then steam sterilised in an autoclave. This Another is whether the material will disrupt the • Should be open to customer combination of heat and water in the form of cycle process by reducing the available H2O2 on-site auditing. steam limits the selection of plastic materials to to achieve sterilisation. Sensors on these a handful of candidates. systems track H2O2 availability. When it drops below an acceptable range, the sterilisation There has been a trend recently to make single-use devices that cycle is aborted, requiring the process to be re-started. Some can then be handled as revenue generators for the OEM and thermoplastics are eliminated from consideration due to this even billed to the patient when used in a surgical procedure. Currently, though they are perfectly fine after exposure to this environment. reusable devices are provided at no cost to the surgeon to support the surgical procedure that places the implant in the body. Finally, ethylene oxide (EtO) is a bulk sterilisation process for However, these are not billable items. Thus, with the migration to single use devices. EtO does not present any compatibility single use devices increasing, the sterilisation method is changing challenges with plastics but has an affinity to some and residuals to one in which gamma exposure with the device in package is become an issue. preferred. Gamma radiation will create changes in the polymer One filter to consider for a material selection for a device intended which again captures the eye of the FDA with respect to the for cold sterilisation is the chemical resistance of the material to validity of the ISO 10993 test performed on raw materials that hydrogen peroxide. Another is whether the material will disrupt were not exposed to radiation prior to testing. the cycle process by reducing the available H2O2 to achieve sterilisation. Sensors on these systems track H2O2 availability. Some raw materials ultimately end up in surgical devices that also When it drops below an acceptable range, the sterilisation contain sensitive electronic components. If these are repeated use cycle is aborted, requiring the process to be re-started. Some devices, the sterilisation process needs to be something that can thermoplastics are eliminated from consideration due to this even occur at the hospital and does not use heat and moisture. Cold though they are perfectly fine after exposure to this environment. sterilisation employs hydrogen peroxide plasma gas at temps of sterilisation methods. Finally, ethylene oxide (EtO) is a bulk sterilisation process for single use devices. EtO does not present any compatibility challenges with plastics but has an affinity to some and residuals become an issue. • Large and diversified inventory in stock

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MICRO MOULDING

It’s the little things... A

n important movement within the medical device industry is poised to revolutionise the point-of-care (POC) drug delivery market. The goal at hand — making drug delivery devices more convenient, painless, and effective for patients — is one that MTD explains how MTD Micro Molding is helping companies to micro-moulding is achieve. shaping the future New advances in medical micro-moulding are of drug delivery creating solutions for a variety of drug delivery applications. As a result, many medical device companies are working with MTD to help set the new standard for manufacturing drug delivery components. It’s a development that could transform the market The advantages of micro-moulding drug delivery components include: • Improved dimensional stability • Sharply reduced production costs • Elimination of timely, costly, and inaccurate assembly steps Advanced micro-moulding will help forward-thinking medical device companies get their innovative products to market, forging a new path that competitors will likely follow.

Eliminating high-risk steps An injectable drug delivery systems company was struggling with the traditional manufacturing methods for its drug delivery device. The process included a series of high-risk, cumbersome steps to manually assemble four micro components to combine the cannula and housing. Cost concerns were also a factor, as these steps required having an entire room of people assembling components at one time. MTD worked with the company to define a possible solution: micro-moulding all the components together at once. Results of an initial mould flow analysis showed this was a feasible approach. Surprised at the results, MTD performed a second analysis to be sure. In parallel, the customer had an analysis performed as well. Sure enough, micro-moulding success was deemed possible. Solid performance: The advantages of micromoulding drug delivery components include improved dimensional stability, says MTD

The successful micro-moulding of this device eliminated three assembly steps (which had been assumed to be required as the industry norm) and created huge cost savings for the customer. The geometry-rich cannula was micro-moulded at $0.10 a unit, in contrast with making four separate components at a cost of over $1.50 for the set (excluding assembly costs). In addition, with the assembly steps largely contributing to the main failure mode in the final device, moulding the device as a single unit removed all possibilities for functional failures.

MTD comments that advanced micro-moulding will help medical device companies get their products to market

Most manufacturers of similar cannula components use fluoropolymers, a common method for converting an extrusion into a heat-formed product. However, this process is very expensive and has a high fallout rate. Fluoropolymers are known for chemical resistance, lubricity and heat resistance but are shear-sensitive. Because of those properties they are suited to being heat-formed but not good candidates for thin-wall moulding. Polypropylene is a material that has great chemical resistance and lubricity and is not shear-sensitive. While polypropylene cannot be heat-formed, it does offer much better melt flow in thinwalled applications, such as cannulas. Traditional manufacturing methods for the development of cannulas have used the heat-forming process of converting fluoropolymer extrusions to cannulas. Next-generation products will likely follow the new advances that MTD is enabling by instead using polypropylene for cannula products. The fear of switching materials midstream, which involves a costly re-approval process, is common to many companies. With this customer however, the long-term savings far outweighed the cost of the approval process. In terms of technical execution, it is extremely difficult to make a long, thin, straight part such as a cannula. The challenge lies in the fact that for a 0.005” wall thickness to flow long-distance, a tiny, delicate core pin must be centered precisely in the cavity. With long length of thin flow, if material flow becomes uneven, it is impossible to fill an annular ring. When flow becomes unbalanced, a hydraulic effect is created on one side and pushes the core pin, which produces an ultra-thin wall on the opposite side. This, in turn, causes fill problems and distortion.

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MICRO MOULDING

Precise control over the position of the core is critical, which is why highly capable tooling and moulding machines are required to successfully mould a thin-walled cannula. This realisation — along with the determination that polypropylene was the better choice for the customer’s cannula application — meant MTD helped set a new standard that will revolutionise the POC drug delivery market.

Other emerging “patient comfort” applications that are coming to light are drug delivery devices for chronic illnesses like sinusitis, an inflammation of the tissue lining the sinuses. This bioabsorbable device, used after surgery, is coated with an anti-inflammatory drug and releases the drug over a period of time. It is a superior alternative to revision surgeries that are typically required for chronic sinusitis, for which there is no cure, or daily oral medications.

Long-term, implantable products There is a movement in the market to reduce office visits for pain management and make infrequent scheduled procedures for degenerative diseases the norm. We have seen two examples of these types of products that were improved with micro moulding: one-time use applications and permanent refillable applications.

One-time use applications A customer came to MTD with a time-release pharmaceutical application to treat macular degeneration consisting of an active drug compounded with a bioabsorbable material that gets implanted inside the eye. The carrier dissolves, delivering the drug over an extended period of time. This painless procedure is a welcome alternative to the typical treatment of needle injections into the patient’s eye every 30 days. Like the cannula company, this customer began with extrusion to create its product, which it perceived to be the only solution. The extrusion process produced a high level of active drug loss, however. MTD was approached to attempt micro-moulding this product to minimise active drug loss and improve dimensional stability. This project also had other interesting challenges. With test batches of the compounded material containing the active drug costing about $1 million per kilogram, conservation and proper handling of the material was critical. Also, maintaining the extremely tight tolerances of the critical dimensions was critical to the product’s function because the amount of material that made up the part was directly related to the drug dosage. Dimensional control for such a tiny micro-moulded component (about one-third the size of a grain of rice) required highly precise molding equipment, which MTD specially purchased for the job. The first shot samples revealed stable critical dimensions and almost undetectable active drug loss at about 1%. The key: using standardised equipment, customised to optimise IV loss. High-precision machines that are less abusive to sensitive materials enable extremely high control of critical processing parameters.

This customer came to MTD after working with a competitor of ours who was unable to produce acceptable post-moulded IV, with loss averaging about 35%. The critical features (multiple micro throughholes) of the bioabsorbable component were also unable to be dimensionally controlled with the previous supplier. This caused many issues in the secondary manual assembly step. The first shots MTD produced for the customer revealed crisp features, capable critical dimensions, and IV loss of 3.4%.

Permanent refillable applications Permanent drug-eluting products are a better option for certain applications. One emerging device is an assembly of parts that is inserted into the body and slowly releases a drug over time, which is less shocking to the patient’s system. Providing a novel approach to delivering drugs, this device includes a porous delivery port, drug chamber, and silicone seal. The drug chamber is a rechargeable well with a 0.0035” wall thickness; this thin wall is important to maintain the highest volume of drug for a very small space. The well-like device is implanted once, weeps out a refillable drug from a reservoir and is refillable via infrequent injections.

A final word The marketplace for POC drug delivery is expanding. The ability to produce cannulas with extremely thin walls as well as ultra-precise drug delivery components that historically have not been able to be molded is the key to this development. When the question becomes, “How can we make things smaller and the fluid path more precise?” the answer clearly leads to micro-moulding. The movement to provide more convenient, painless, and effective drug delivery devices to patients is pushing the most innovative and forwardthinking companies to break the paradigm of what drug delivery devices can be. These companies are thinking outside the box while solving patients’ problems with new tools. The result is drug delivery devices that create a whole new platform for pharma companies to deliver drugs to the masses with ease.

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Operation accuracy: The Protector metal separator features high detection accuracy and guarantees reliable operation of injectionmoulding machines

It’s a wrap S

ixty injection-moulding machines for the production of inhalators, eye drop dispensers, and nasal spray containers have been equipped with Sesotec metal detectors.

Pharmaceutical packaging manufacturer benefits from accuracy with metal detectors

Quality is paramount to a manufacturer of pharmaceutical packaging. And this is true in all phases of the production processes – from product design to production sequences and through to 100% inline testing. The high quality of the products is the result of sophisticated processes and efficient systems.

A reduction in customer complaints is the most important indicator for how the company views quality standards. Other criteria also are considered with the aim of remedying defects, reducing the number of errors and increasing customer satisfaction.

Protection of injection moulds One of the packaging manufacturer’s plants almost exclusively produces articles for the pharmaceutical industry. About 25 different products are made with a variety of hot runner moulds, with quantities of almost one million per year. Each of these products in turn can comprise up to 27 individual parts that are all injected in the same plant. Some of the large moulds have 48 cavities. All the injection-moulding machines operate in hygienically closed halls. Since 2011 the company has equipped its injection moulding machines with Protector Primus Sesotec metal detectors to remove metal contaminations from the plastic granulate.

There were three reasons for the purchasing of metal detectors: 1.They avoid machine damage caused by metal particles which eg choke cavities and lead to expensive repair work. 2.There are no longer production losses due to machine downtimes. 3.That there are no more customer complaints due to contaminated or underinjected products.

How Protector metal detectors work Protector metal detectors were installed directly above the material inlet of injection moulding machines, where they remove metallic contaminations from the slowly descending material column. Apart from outstanding properties such as high sensitivity and space-saving, compact design, Protector metal detectors boast a ‘quick-valve’ reject unit. When a metal particle is detected a pneumaticallycontrolled piston in this reject unit moves into its reject position and the rejected material is completely sucked into a collecting container using a Venturi nozzle. The piston then moves back to its pass-through position. A negligible amount of good material is lost in this process and clogging is claimed to be impossible. The project manager of the pharmaceutical packaging manufacturer is highly satisfied with the Sesotec Protector metal detectors: “We are particularly convinced by the high detection accuracy and the high reliability of the systems, and by the ease of operation provided by the Primus control unit.”

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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

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ORTHOPAEDICS

Keep on moving R

ecent UK press reports have highlighted an alleged error in hip implant manufacturing. According to a story that broke in The Telegraph, metal-on-metal implants with manufacturing issues mean thousands could be seeking compensation from DePuy. Of course, we’re not talking medical plastics here but it’s not the only press focus the sector has had of late. An increasing number of women are requiring hip replacements in their 40s. In the UK one-time ballerina, now a judge on a prime-time TV dancing show, Darcey Bussell announced that she had her hip resurfaced but may need a hip replacement due to the toll dancing has taken on her body.

Keep on running? Professional dancers aren’t the only ones experiencing the need for this type of A boom in exercise orthopaedic surgery. According to the Daily is leading to a rise Mail, “In 2013, 66,000 replacements were in orthopaedic carried out - and the number is increasing. procedures. Lu But while most are given to people aged 60 to 80, operations on younger patients Rahman looks at the are becoming more common, according to sector and an exciting leading orthopaedic surgeon, Mr Tim Waters development for of Spire Bushey Hospital”. And the reason? those who experience Exercise. With younger people requiring these type of joint replacements – made from leg-lengthening a combination of stainless steel, titanium, discrepancy plastic and ceramic – the orthopaedic market is encountering additional growth. The sector already benefits from a rising elderly population as well as an increase in obesity, osteoarthritis and osteoporosis. According to a report by Transparency Market Research technological advances such as bioabsorbable implants and the increase in the success rate of these implants, make this sector an attractive opportunity for investors. The orthopaedic market is a significant part of the medtech sector – figures from EvaluateMedTech place it third behind cardiology and in vitro diagnostics.

Evonik investment Developments in the sector are on-going. Evonik Industries recently invested in start-up company Synoste via its venture capital arm and now holds a minority share in the medical technology company. Synoste is a spin-off of the Aalto University in Finland. Together with Orton, a Helsinki hospital which specialises in orthopaedics, Synoste has developed a high-tech implant for a minimally invasive treatment of leg length discrepancy, which can lead to chronic back pain and osteoarthritis in the long term. The bone of the shorter leg is lengthened gently over the period of several months. For the patient the implant represents easier treatment with less pain and lower risk compared with established methods. “Medical technology is one of the strategic growth fields of Evonik,” says Bernhard Mohr, head of venture capital at Evonik. “At the same time, we have outstanding materials competence in high performance polymers, which makes Synoste an excellent fit for Evonik.”

The start-up is expected to launch the implant – NitinailTM – on the market in 2017. It is currently undergoing CE approval. “We are happy to have found a strategic partner in Evonik, who is supporting us in this important phase with its material competence,” explains Harri Hallila, CEO and co-founder of Synoste. Vestakeep PEEK, a high performance polymer from Evonik, will also be used in the implant. Due to its mechanical properties and biocompatibility, Vestakeep PEEK is well established in implant, dental and medical technologies. “By investing in Synoste we hope to open up a n e w , extremely innovative application for Vestakeep PEEK and enhance our business and expertise in the field of medical technology,” says Matthias Kottenhahn, who heads the high performance polymers business line at Evonik. Synoste’s implant technology does not just offer potential in leg-lengthening but also for deformities in arms, fingers and toes as well as spine and craniomaxillofacial surgery.

Better quality of life for patients There are various reasons why legs might be different in length – this could occur from birth or as a result of an accident or cancer. According to estimates, some 30,000 people worldwide receive treatment per year. The standard treatment method involves the use of an external fixator – a construction made of steel which is fixed to the bone and the outside of the leg. This method does, however, pose the risk of infection and is also painful and uncomfortable. The implant offered by Synoste is similar to an intramedullary nail and is fixed to the bone after the bone has been cut. During the treatment period, which lasts for several months, it is extended in small increments of 0.5 millimeters, like a telescope, by electromagnetic means. This causes fresh bone substance to steadily form between the two halves of the bone. Using this method, it is possible to increase the length of the bone by several centimetres. An advantage of the implant from Synoste is said to be its high mechanical stability. Synoste targets to allow patients to bear full weight on their leg at an early stage in the treatment process. Furthermore, it significantly reduces the risk of infection compared to a fixator and requires shorter hospitalisation.

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COMPOUNDING

Results driven: The results of three of the post-extrusion operations that must be taken into consideration when developing TPEs as alternatives to PVC

COMPOUND INTEREST I

n compounding plASTics for medical devices, use of dedicated processing lines to ensure product purity is just a starting point. Equally fundamental is the need for sophisticated process controls and production monitoring systems to meet stringent codes and critical performance requirements, as well as to provide device manufacturers with lot to lot documentation. Beyond these basic considerations, medical compounders face new challenges with every formulation M Galland and Ross that they develop.

Peter Van Royen, Teknor Apex Company, discuss the challenges in compounding medical polymers

The challenges vary with the type of polymer. Teknor Apex specialises in medical compounds based on flexible and rigid PVC and on thermoplASTic elASTomers (TPEs). While having extensive involvement in two major medical product ranges generates valuable technical and marketing synergies, each of these polymer families also poses its own unique compounding challenges.

PVC compounds: Evolving plASTiciser formulations A major challenge confronting PVC device manufacturers today is that of issues involving ortho-phthalate plASTicisers, particularly DEHP, which is widely used in medical-grade PVC and has decades of application history. Selecting alternative plASTicisers for use in producing medical compounds is not a simple matter, since most alternatives now available entail some compromise in cost or performance in comparison with DEHP, and since different device applications pose different plASTicising requirements. Key considerations for evaluating alternative plASTicisers include chemical structure, toxicology, solubility, migration, crazing, Sterisslisation, mechanical properties, processing, design, economics, and current market penetration. As a producer of both plASTicisers and PVC

compounds, Teknor Apex has prepared comprehensive data on plASTiciser alternatives as a way to help device manufacturers make informed decisions in addressing marketplace issues concerning phthalates. The company is prepared to work with designers and processors no matter which alternatives they select. One example of the complications that arise when selecting plASTicisers has to do with applications where a flexible PVC device, such as tubing, comes into contact with nonPVC rigid components, such as ABS, acrylic, polycarbonate (PC), or polystyrene (PS). Certain plASTicisers can cause softening, cracking, or other defects in these components as they migrate across the interface from the component made of PVC. In some cases the problem can be avoided by switching to rigid PVC for the component to be used in contact with the flexible PVC device. In fact, Teknor Apex has developed a rigid PVC to replace PC in clear medical components such as connectors and check valves, obtaining comparable strength and excellent clarity while reducing or eliminating the stress cracking that often occurs in PC at the interface with flexible PVC components such as tubing.

TPEs: Optimising performance vs incumbent materials TPEs bring unique capabilities to the medical device industry, and in some cases these benefits represent valuable cost/performance advantages over conventional incumbent materials such as PVC and thermoset rubber. Two of the challenges facing compounders of medicalgrade TPEs are: 1 developing a range of compounds broad enough to match the diversity of requirements in the many well-established applications dominated by conventional materials 2 perfecting the TPE compounds not just in terms of properties to be found on data sheets but in terms of real-world requirements.

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COMPOUNDING

To meet the first challenge, Teknor Apex has developed a broad family of medical compounds, called Medalist, for applications as diverse as tubing, solution bags, syringe stoppers, dropper bulbs, face masks, films, drip chambers, gaskets, valves and even medical device cable insulation and jacketing. This has involved making use of a range of TPE polymer types, including styrenic, olefinic, vulcanizate, and alloy formulations, with hardness offerings ranging from ultra-soft gels at 25 Shore OO to hard yet ductile compounds at 60 Shore D. (Customer options can be further broadened by customising the surface aesthetics, haptics, clarity and colour.) Medalist compounds are produced in facilities certified under ISO-13485, an international standard for quality management in medical manufacturing. The second challenge, anticipating practical, realworld requirements, means that new formulations must be tested not only for essential physical properties and pre-compliance with regulations, but also for characteristics that are critical for sterilisation, chemical resistance, fabrication, assembly, and everyday handling by healthcare workers in clinical settings. To develop truly practical TPE alternatives to PVC in tubing, for example, Teknor Apex worked with medical industry experts, processors, and equipment suppliers to ensure that downstream processes like hole cutting, tipping, and printing would not be an issue. Medalist tubing compounds meet such functional requirements as gamma stability, autoclavability, bondability to connectors, clarity, flexibility, kink resistance, clamp resilience, and resistance to â&#x20AC;&#x153;neckingâ&#x20AC;? when subjected to longitudinal force. It was determined that clinical workers would not find acceptable any TPE tubing that did not duplicate the look and feel, or haptics, of the PVC tubing to which they were long accustomed. For a haptics test, Teknor Apex sought the opinion of experienced individuals in the medical industry, who participated in blind tests with one PVC tube mixed with several produced from the new TPE compounds. They couldnâ&#x20AC;&#x2122;t tell the difference. Probably no other major market for plASTics is as demanding as that of medical devices. One of the many challenges in manufacturing medical compounds is to develop formulation and processing technologies in order to meet or even anticipate regulations, market trends, and end use practices. Successful compounders are those that have invested in the capabilities needed to meet this challenge. Joint effort: The combination of PVC tubing and rigid connectors that compounders must take into consideration when selecting alternative plasticiserss

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STERILISATION

Premier league: Steri AST says that all its sterilisation services are fully supported by a first-class network of laboratories

Cleaning up

hat do you look for in a sterilisation supplier? Reliability? Innovative sterilisation solutions? Continuity of supply? Steris AST, formerly known as Synergy Health, asked this very question, which resulted in multi-million Sterilisation specialist, pound expansion projects across the Steris AST, reveals EMEA region.

investment plans to support the European Industry training medical device industry

In order to ensure employees have first class technological and regulatory compliance knowledge, Steris AST offers a training programme. Its 2016 scheme will begin with its annual conference at the beginning of March – this event will focus on topics associated with terminal sterilisation and aseptic manufacturing. As well as in-house experts, the conference will feature guest speakers from BSI, European Medical Contract Manufacturing BV (EMCM), Associates of Cape Cod (ACC) and Anecto together with a keynote speaker discussing challenges and pitfalls of device development. This is the third annual conference highlighting the continued requirement to support the training and development needs of the European medical device industry. Steris AST offers a range of training and educational opportunities from webinars to tailored workshops and bespoke customer training, allowing companies to specifically focusing on their organisation’s sterilisation requirements.

Supply chain innovation Steris AST says it understands the importance of listening to its customers paying specific attention to supply chain innovation which has resulted in an investment of over £18m in expansions to support customers’ requirements. It adds that customers of the technology neutral supplier will benefit from increased global capacity in radiation (gamma, electron beam and X-ray), ethylene oxide and laboratories. The European phase of the expansion project will provide increased gamma capacity in Ede, Netherlands and Bradford, UK. Radeberg, Germany will benefit from expansions in both gamma and electron beam in addition to an expansion of the warehouse.

Other projects the company has been carting out include a new laboratory which is under construction in Radeberg and the expansion of the facility in Seriate, Italy, both of which will strengthen the regional network supporting the medical device and pharmaceutical testing requirements.

Research and development As the European medical device industry continues to lead with innovate products, Steris AST has made further investments in research and development to support industry innovation. A new R&D gamma testing irradiator has been installed in Marcoule, France using a design capable of providing specific targeted doses.

Supporting role: Steris AST has carried out a range of investments to help support the European medical device sector

A global integrated network As a full service supplier, Steris AST says that all its sterilisation services are fully supported by a first-class network of laboratories. The new laboratory in Radeberg is being created to support the strong growth in customers from Germany, Switzerland, Austria and Poland using this facility and sister sites in Allershausen, Germany and Daniken, Switzerland. The laboratory will offer the ability to test according to ISO 11137 with bioburden, environmental and LAL testing facilities and a GMP compliant class 7 cleanroom. Mark Botting, EMEA laboratory business director said “We are pleased that the Steris AST board has agreed to further investment in the EMEA Laboratory network and this will support the strong network we already have in the UK, Netherlands, Ireland and Italy which has supported the regulatory requirements of our customer base for over 20 years.”

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ADHESIVES

Skin tight: Examples of wearable wireless electronic devices courtesy of John Rogers, University of Illinois

Do wearables hold the key to

the adhesives market?

dhesives are critical components in the design and “If we focus our crystal ball on the medical market and look manufacture of the majority of medical devices. As at the trends for the next five to ten years we are receiving medical devices become smaller and more complex, an increasing number of enquiries from design engineers greater demands are being made on the materials and involved in the research and development of wearable components used in them. Even more exciting are estimates medical devices that will not come to market until 2020 or that only about one-half of the applications that could be after; indicating that this is a fast growing market. We are served by adhesives are actually seeing new product development and technical advances using adhesives in assembly, every day.” Techsil looks at the leaving significant growth This is backed up by the latest research future for medical device opportunity. The global which says by 2018, the market size for medical adhesive market adhesives and the growing is projected to reach wearable medical devices is estimated importance that the $10,015.67 million by 2019, to reach $12 billion, increasing 6.5 times compared to today. wearable market holds growing at a CAGR of 9.65% between 2014 and Research says by Dilley adds: “I see a future where 2019. (MarketsandMarkets 2018, the market electronics are part of our clothes Research Report May size for wearable and wearable diagnostic technology 2015). However, some of this growth will result from improved processing methods and technology and medical devices is will become ubiquitous. For example not just new adhesive advancements. Application and estimated to reach someone with diabetes might look at their shirt cuff and an electronic sensor curing equipment play a critical role in the design and $12 billion will measure insulin levels and remind manufacture of these devices. the reader to take it. Or an electronic badge incorporated to your overalls that Wearable market interest will flash if you go into a gaseous area UK-based adhesive distributor Techsil is often offered a and are at risk of falling unconscious.” glimpse into the future via the enquiries it receives from design engineers working in the research and development Some of the latest wearable medical device designs include – emergency call buttons, smart clothing that stage of future products. measures vital outputs and wearable sensors that Sales director, Chris Dilley comments: “The last few monitor individual’s outputs and wirelessly transmit the years has seen us working with design engineers from data to health professionals. The developing technology the automotive sector developing adhesives for driverless of E-textiles, based on electrically-active woven fibres, braking and steering technology in cars which are now a used in smart apparel, bandages and bed linen will be able to sense and emit light, heat, cool, change shape, reality and expected to be on our roads by 2025. compute and wirelessly communicate, sometimes even

“

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ADHESIVES

diagnose and treat medical conditions! This offers huge opportunities in the merging healthcare, medical, fitness and wellness sector. As the adhesives industry responds to the challenges of this market, new advances are widening the performance envelope for medical adhesives. Variations in polymer compositions, coupled with compounding differences, are allowing properties to be tailored to meet specific application requirements, including: ■ ■ ■ ■ ■ ■ ■ ■

Bio-stability Flexibility for comfort Electrically conductive Sterilisation resistant Snap cure with light Solvent free Thermal stability Easily automated

In November 2015 researchers at MIT announced the development of a new synthetic hydrogel superglue which mimics the way mussels and barnacles tightly glue themselves to ship hulls or whales. The transparent, rubberlike adhesive is 90% water and its bonding toughness is orders of magnitude higher than any previous hydrogel glue. As the hydrogel is biocompatible, it may also be suitable for a range of health-related applications, such as biomedical coatings for catheters and sensors implanted in the body. Similarly researchers at UC Santa Barbara have designed an adhesive also based on mussels which forms atomically smooth, ultra thin glue layers which hold particular promise for the fabrication of nano-scale electronic devices, including circuits and battery components. We keenly watch this space for the next exciting adhesives that might come to market following these new discoveries and other like them.

Techsil recently introduced a new jettable conductive adhesive to the UK market from adhesive manufacturers Panacol. According to Dilley: “Jet dispense compatibility and snap cure make these conductive adhesives an ideal choice for high speed production of wearable electronics. Conductive adhesives are used for bonding electronic components onto flexible substrates that ordinary metal solder would melt. And the adhesive is more comfortable next to skin than solder.” Other advances in medical devices that are designed to operate on a patient’s skin or even inside the patient’s body, present medical adhesive manufacturers with probably the toughest challenges yet where the adhesive may need to be: Biocompatibility and non-toxic Able to adapt to moisture changes in skin to offer extended wear time ■ Handle fluids, adhere to wet surfaces, be breathable and/or absorbent ■ Flexible to bond to movable areas such as elbow or knee joints ■ Contain embedded chemicals for transdermal delivery ■ Easily removable ■ Be transparent ■ To dissolve ■ ■

“

I see a future where electronics are part of our clothes and wearable diagnostic technology will become ubiquitous. For example someone with diabetes might look at their shirt cuff and an electronic sensor will measure insulin levels and remind the reader to take it. Chris Dilley

sales director, Techsil

New adhesive formulations are being discovered all the time – many inspired by ‘sticky things’ found in nature. In August 2015 a ‘gecko-inspired’ adhesive went into mass production.

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of cataloguing and distributing our clear bone models to its distributors.

Describe your latest innovation?

BEADY

eye

Keeping an eye on the next big thing can be hard. Each issue of MPN selects a company, service or technology that it thinks is the one to watch . . . Who are you and what do you do?

Encoris is a fast growing medical modelling company located on the beautiful shores of Lake Michigan.

Jim TenBrink, Encoris, explains how medical models can benefit medical device firms and the wider medical sector

Our company develops and manufactures medical sales demonstration / patient education models and surgical trainers for trade show displays, medical device promotion and medical education. Encoris is not your off-the-shelf, typical company – we customise product solutions that help medical device companies cut costs, differentiate and enhance the features and benefits of their medical devices.

MODEL example

What projects have you been focused on recently?

An Italian university, which serves as an incubator for surgical training model ideas, has initiated an agreement with Encoris to develop, manufacture and commercialise surgical training models worldwide. The first project involves a redesign on a patented ultrasound kidney trainer for PCNL training. Given our knowledge of life-like materials and mould-making processes, we are enhancing the model to provide better anatomical and tactile realism, to be more user friendly and have a much longer shelf life. The model is a non-biological, re-usable, ultrasound and X-ray compatible and it can be adapted for different kinds of renal presentations - hydronephrotic, staghorn stone, upper or lower caliceal stones, etc. The model has already been used and appreciated at the EULIS Masterclass in Milan. We are also currently working on developing a partnership with a German based company who strictly creates anatomical foam models. The company sought Encoris for our quality clear medical models and is considering the opportunity

We have patented a surgical training model platform designed to revolutionise the way surgeons train on the latest medical devices and surgical procedures. Using the latest app technologies and life-like soft tissue materials, the encOR-m.i.s. Surgical SmartTrainer (SST) promises to make significant advancements in orthopeadic surgical training, specifically for minimally invasive surgery (MIS). Termed ‘OR in a box’, the trainer is all-encompassing, providing x-ray-like illuminated anatomy and built in pathologies offering a hands-on training experience for surgical placement of medical implants. Built into the model’s CPU is a customised web app that works in conjunction with computer-driven visual aids, allowing trainees to see full A/P/L visuals of the internal, intricate details of the surgical procedure. The proprietary app captures realtime video feed and wirelessly displays the surgical footage onto a password-protected website, viewable on any desktop, iPad, tablet, or smartphone device – a big plus for trade show venues with large crowds or educators who can now provide remote training via the web to distributors and surgeons worldwide. Utilising the latest app software and visual technologies, coupled with anatomic life-like realism, medical device companies are now able to safely and cost effectively show and practice the latest M.I.S. techniques without the logistical limitations, expense and radiation hazards of conventional cadaveric training.

Either way, FlexClear bones are repeatable and allows the surgeon to have a more realistic, hands-on, visual experience when demonstrating an implant.

What does it mean for the medical sector?

The manufacturing process we use to develop our models is unique to Encoris and has benefited the medical sector well. Using CAD and 3D printing saves our medical device clients a lot of time and money; having the ability to create 100% accurate models in real time, has given our customers peace-of-mind that their products and projects will be manufactured correctly and on time. Working with accurate models brings about a more knowledgeable, safer, more confident surgeon, which ultimately brings greater peace of mind to patients the world over. In addition, our medical models help better show and demonstrate the features and benefits of a medical device, which empowers our medical device customers with greater confidence to sell and educate surgeons on the latest technologies.

Plans for the future?

The foam bones are dusty and brittle. They’re also solid and completely hide the unique features of the implant the educator is trying to demonstrate. FlexClear bones, being made out of pliable urethane, are flexible and transparent.

We plan to keep on developing As Encoris’ products and services continue to grow in popularity, demand for models outside of the orthopaedic market will grow in areas such as general surgery, ultrasound training, gynecology, minimally invasive surgery, dental, and veterinary medicine. With the continuing developments of our Surgical Smart Trainer technology, hospitals and medical entities alike will someday have the ability to remotely assess a surgeon’s skill level on a particular surgical procedure and implement necessary corrections in an effort to reduce the chances of medical malpractice.

Using CAD design, pathways for placing the implant can be created and moulded right into the bone anatomy or the client can drill or tap the bone models themselves.

We can also see this technology being used for battlefields or any environment where emergency medical/surgical attention is needed.

Another innovation is called FlexClear bones. When it comes to workshop training, the competition offers one-time use foam bones for demonstrating surgical applications of medical implants.