MEDICAL PLASTICS news
+
The latest in vascular access devices and antimicrobial trends How 3D printing is improving lead times in device manufacture
MAKING ADVANCES
- Engel brings innovation and technology to medical plastics ISSUE 31
July-Aug 2016
WWW.MEDICALPLASTICSNEWS.COM
At Phillips-Medisize We’re All About Process
We know process is the absolute key to assuring that we deliver upon our customers’ expectations, the first time and every time. That’s why our people are all about process. In fact, our process requirements apply not only to manufacturing and quality SOPs, but also to our customer facing operations such as Program Management and Design and Development engagements, ensuring our customers benefit from a repeatable and scalable model. So, when you work with Phillips-Medisize, you can be certain we’ll exceed your highest expectations the first time and every time.
Contact Phillips-Medisize: phillipsmedisize.com / eu_sales@phillipsmedisize.com
CONTENTS July-Aug 2016, Issue 31
20 Cover story Engel Medical outlines how innovative technologies are paving the way for efficient pharmaceutical packaging and drug carriers
Regulars 5 Comment Lu Rahman looks at the global importance of medtech the sector 7 News analysis The role of polymers in soft robotics 8 Digital spy 10 News profile How Evonik is leading the way in biodegradable polymers for implants 14 News analysis New research has led to the development of a biofilm which could mean an improved success rate for implants 19 Opinion Stibo Systems, explains how product-as-a-service is disrupting the device market
46 Medtech at the movies
Features 23 On point Cikautxo Medical outlines the latest developments in vascular access devices and antimicrobial trends 27 Matter in hand Henniker and Zwick highlight expertise in catheter manufacture 31 I’m only human Lu Rahman looks at the growing importance of human factors engineering
32 Surgical spirit King’s College Hospital improves patient care using Stratasys 3D printing 34 Time travel The Tech Group examines how 3D printing is benefitting medical device contract manufacture 38 Stretching the boundaries Kuraray America, explains how safety and performance lead the way for use of thermoplastic elastomers 43 Rise of the machines How robots will shape the future face of manufacturing 44 Clean sweep Connect 2 Cleanrooms describes how it can deliver customer-driven cleanroom innovation
WWW.MEDICALPLASTICSNEWS.COM
3
Idea. Prototype. Done.
(It’s as simple as that.)
We offer more than 100 thermoplastics resins, metal and liquid silicone rubber.
We understand that getting your product to market on time is critical in the medical sector. We manufacture custom prototypes and low-volume production parts within 1-15 days. 3D PRINTING | CNC MACHINING | INJECTION MOULDING
Emma Spilsbury Account Manager
Order online anytime | Free design analysis
protolabs.co.uk +44 (0) 1952 683047 customerservice@protolabs.co.uk
CREDITS
EDITOR’S
group editor | lu rahman
comment
deputy group editor | dave gray advertising | gaurav avasthi art | sam hamlyn publisher | duncan wood
Medical Plastics News is available on free subscription to readers qualifying under the publisher’s terms of control. Those outside the criteria may subscribe at the following annual rates: UK: £80 Europe and rest of the world: £115 subscription enquiries to subscriptions@rapidnews.com
Medical Plastics News is published by: Rapid Life Sciences Ltd, Carlton House, Sandpiper Way, Chester Business Park, Chester, CH4 9QE T: +44(0)1244 680222 F: +44(0)1244 671074 © 2016 Rapid Life Sciences Ltd While every attempt has been made to ensure that the information contained within this publication is accurate the publisher accepts no liability for information published in error, or for views expressed. All rights for Medical Plastics News are reserved. Reproduction in whole or in part without prior written permission from the publisher is strictly prohibited.
BPA Worldwide Membership
ISSN No: 2047 - 4741 (Print) 2047 - 475X (Digital)
global warming
U
K and European readers will be well aware of the political rollercoaster on which Britain has been travelling since the EU referendum. For our US readers, I’m sure it hasn’t escaped your notice that over recent weeks the political landscape has changed almost daily and with dramatic effect. At the time of writing we not only have a new prime minster in the UK but we have also been told that country’s minister for life sciences, George Freeman, has been moved from his post. It is unclear, but it seems that his role won’t be filled by another politician. It’s a puzzling decision. The UK has very little world-class expertise yet its life science sector is a global success and held in high regard. The sector adds £60 billion to the UK economy each year employing 220,000 people. In a recent statement discussing the sector’s new relationship with the EU following the referendum, and the UK’s commitment to the life science sector, Freeman highlighted how life sciences were “of critical importance to the economy” and that following Brexit, “neither the UK’s commitment to the life science sector nor our legal relationship with Europe have in any way changed, and that it is likely that some time will elapse before any changes to the latter are agreed”. Given this commitment, the success of the sector and the fact that Freemen was pivotal in the creation of the UK’s 10 year Life Science Strategy back in 2011, the removal of the position is disappointing.
Not only in the UK but globally, the life science community is a success story. At a time of global turmoil – politically and economically – collaboration between organisations working to improve healthcare outcomes for international communities is to be celebrated. The contribution that sector makes to the global economy is not to be sniffed at either. According to a report by Visiongain, the global medical device market will reach $398.0bn in 2017 with strong growth predicted until 2023. It adds that the medical devices industry is likely to witness significant growth opportunities over the next ten years with market expansion being driven by the introduction of innovative devices to the market along with increased demand from an ageing population.
“
Not only in the UK but globally, the life science community is a success story.
In the UK alone, this week we heard of a £60 million partnership between business, healthcare and academic in the North West that will lead to £100 million worth of growth and 750 jobs for the life science sector. Science parks in the UK have grown at a considerable rate over recent years – according to AMA Research between 1982 and 2014 these have increased from two to 104 in the UK, highlighting the need for expertise and collaboration at a high level. Despite the uncertainty of individual political events – past and yet to come – it’s clear that the medtech sector has a positive effect on a global scale, contributing significantly to the world-wide economy. While the new UK government may feel that a dedicated minister for the sector is an extravagance – we have yet to see – the dedication of those working in this field both in the UK and internationally, cannot be under estimated.
WWW.MEDICALPLASTICSNEWS.COM
5
Get Your Catheter to Market Faster Our New Customer Solution Centre is all about encouraging collaboration and innovation, reducing technical risk, developing a more market-ready product, and increasing speed to market
Work with our team. Share ideas. Refine concepts.
Examine each of the device’s elements with a focus on design for manufacturability.
• Dedicated facility, in Limerick, Ireland, was built to foster innovation and maximize sharing of ideas and technologies • Nine-step development process builds in your unique requirements early in the concept stage • Decision making process utilizing our proprietary database of design elements and their contributions to the device’s design
Study demonstrative prototypes; refine design for optimal performance.
• In-house laboratory for testing and validation of device concepts • 3D modeling and printing services • Quick turnaround of demonstrative prototypes • Fully-integrated, in-house capabilities can be customized to the requirements of your project
Phone: +353.61.331906 E-mail: oeminfo@teleflex.com Web: www.teleflexmedicaloem.com ©2016 Teleflex Incorporated. All rights reserved. Teleflex is a registered trademark and “Work with the Experts” is a trademark of Teleflex Incorporated in the U.S. and/or other countries.
Achieve a well-defined device concept.
Work With The Experts™
NEWS ANALYSIS
R
esearchers at the Harvard John A Paulson School of Engineering and Applied Sciences (SEAS) have developed a dielectric elastomer with a range of motion that requires relatively low voltage and no rigid components.
Advances in polymers BRING DEVELOPMENT OF SOFT ROBOTICS CLOSER
A
ccording to the NSF, novel robotic devices – or soft robotics – hold several benefits over conventional robots. They are more manoeuvrable and have better interaction with humans which could be of Work at the National real use in situations with the elderly, for They may also “lead to high-tech Science Foundation example. artificial muscles: a life-changing innovation (NSF) is looking at the for millions of disabled people around the way polymer-based globe”.
materials can be turned into artificial muscles. This could mean says the NSF, that “robots of tomorrow may be able to squish, stretch and squeeze”
Kwang Kim of the University of Nevada, Las Vegas and his National Science Foundation (NSF)-funded team are looking into the development of a powerful, flexible material for the creation of artificial muscles and also how to control and manufacture it.
Kim is heading up the project which involves four US universities plus research institutions in Japan and South Korea. They are investigating the way a novel polymer-based material could be transformed into artificial muscles. According to the NSF, one of the big challenges in soft robotics is finding the right material. Kim’s team is using a material known as an ionic polymer-metal composite. Thanks to the electroactive nature of the polymer, running electricity through it allows its shape to be changed compared with conventional robots which require motors to move. “It has to be soft, but it also has to produce enough power to do lots of different things,” Kim said. The team says electroactive polymers have the ability to sense motion making them ideal for soft robotics and have also come up with a way to 3D print the material.
“We think this has the potential to be the holy grail of soft robotics,” said Mishu Duduta, student at SEAS. “Electricity is easy to store and deliver but until now, the electric fields required to power actuators in soft robots has been too high. This research solves a lot of the challenges in soft actuation by reducing actuation voltage and increasing energy density, while eliminating rigid components.” Duduta co-authored the paper with Robert Wood, the Charles River Professor of Engineering and Applied Sciences and David Clarke, the Extended Tarr Family Professor of Materials. In building a new dielectric elastomer, the team combined two known materials that worked well individually — an elastomer based on one developed at UCLA that eliminated the need for rigid components and an electrode of carbon nanotubes developed in the Clarke Lab. The complementary properties of these two materials enabled the new device to outperform standard dielectric elastomer actuators. Most dielectric elastomers have limited range of motion and need to be prestretched and attached to a rigid frame. Starting with an elastomer that doesn’t need to be pre-stretched, developed by researchers at UCLA, the modified materials begin as liquids and can be cured rapidly under UV light to produce paper-thin sheets. They are sticky — like double-sided tape
WWW.MEDICALPLASTICSNEWS.COM
— so adhere well to each other and the electrodes. For the electrodes, the team replaced carbon greas – typically used as an electrode in dielectric elastomers – with a mat of thin carbon nanotubes. The nanotubes neither increase the stiffness of the elastomer nor decrease the energy density meaning the elastomer can still stretch and provide significant force. The team fabricated a multilayer sandwich of elastomer, electrode, elastomer, electrode and so on. In this way, each electrode gets double usage, powering the elastomer above and below. “The voltage required to actuate dielectric elastomers is directly related to the thickness of the material, so you have to make your dielectric elastomer as thin as possible,” said Duduta. “But really thin elastomers are flimsy and can’t produce force. A multilayer elastomer is much more robust and can actually provide significant force.” “The significance of this work is that the combination of materials and processing enables two of the current technical limitations of dielectric elastomers — the need for high voltage and pre-stretch — to be overcome,” said Clarke. This type of actuator could be used in wearable devices, soft grippers, laparoscopic surgical tools, entirely soft robots or artificial muscles in more complex robotics. “This breakthrough in electrically-controlled soft actuators brings us much closer to muscle-like performance in an engineered system and opens the door for countless applications in soft robotics,” said Wood. The research was supported by the National Science Foundation.
7
DIGITAL
DIGITAL NEWS
spy
BREAKTHROUGH www.sutrue.com
In the Cannes: 3D printing creates new future for surgery
I
nventor Alex Berry and UK heart surgeon Richard Trimlett are using the 3D technology to slash design and production costs, making what Trimlett describes as, “a quantum leap in medical research”. The pair unveiled their automated suturing tool, Sutrue, at the Cannes Lions International Festival of Creativity in June. Sutrue is held like a pen and holds a standard curved surgical needle within a tiny sets of rollers and gears which rotate the needle. Suturing is currently carried out by hand, with forceps used to pick up the needle after every stitch. Sutrue dispenses with the need for forceps, reducing the risk of infection by speeding up the stitching process. There are also implications for robotic surgery - the pair are in negotiation with the European Space Agency over the terms of a research agreement.
Keeping it real: COUNTERFEIT DETECTION CONCENTRATE SAFEGUARDS MEDICAL DEVICES
T
eknor Color Division has launched new colour concentrates with exceedingly small traces of an anti-counterfeit marker or taggant. This will enable plastics manufacturers to ensure product safety, supply chain integrity and brand reputation with no effect on colour quality or product performance.
DeTek functional colour concentrates help brand owners protect against seemingly identical fake products that lack the identifying marker. Such products may damage brand identity by compromising safety, purity, or reliability. DeTek concentrates can also help provide assurance to medical device OEMs that use components from multiple contractors for regulated or highspecification applications.
DEVICE UPDATE “Sutrue allows us to do something we can already do, but do it better and will also enable us to perform new keyhole robotic procedures that would be impossible by hand,” said Trimlett, of the Royal Brompton and Harefield NHS Trust, the largest specialist heart and lung centre in the UK. “Sutrue allows wounds to be closed with consistency and accuracy. There are places, such as field hospitals and war zones, where you don’t have the luxury of time and have to suture with a degree of haste. You reduce the risk of infection by closing the wound more quickly.
T
“Sutrue also opens the way for the high end of keyhole robotics. We are currently quite limited in terms of being able to safely stich inside the body because of the difficulty of complex stitching by hand. With Sutrue we will be able to carry out new procedures robotically.
According to Epilepsy Research UK, the device will be used in a trial of people with drug-resistant mesial temporal lobe epilepsy (MTLE).
“The possibilities are almost limitless with these technologies and robotics. You will be able to have a remote virtual presence through force feedback which gives the user the sensation of touch. When you can’t feel things it slows you down. Force feedback is important, which is why we have the European Space Agency as a partner.”
Dr Robert Gross, professor of Neurosurgery at Emory University, in Atlanta, said: “This is a significant step in collecting evidence regarding laser ablation as a treatment option for MTLE. We are eager to begin enrolling patients.”
The surgeon said that being able to share work on 3D CAD design files with Berry eliminated lengthy and expensive design processes and “suddenly made the development stage instantaneous”. The use of 3D printing has also brought costs of production down from an estimated £3.5million to around £50,000. 8
FDA GIVES GO-AHEAD TO USE OF MEDTRONIC DEVICE IN EPILEPSY TRIAL he FDA has approved the testing of Medtronic’s Visualase laser ablation system in an epilepsy clinical trial.
Visualase is an MRI-guided laser ablation system. It works by delivering laser (or light) energy to the desired area of the brain via a
WWW.MEDICALPLASTICSNEWS.COM
laser applicator, with the assistance of real-time MRI imaging. This makes the temperature in that area rise and coagulate the unwanted soft tissue. The laser applicator is just 1.65 mm in diameter and therefore a minimal suture is required following the operation. The device has already been cleared by the FDA to coagulate or necrotise soft tissue in brain or other specialised surgeries. However this is the first time that it will be trialled in people with epilepsy. Disclaimer: Epilepsy Research UK is completely neutral and is not affiliated with any commercial company, or any particular device/product.
DIGITAL SPY
DIGITAL SPY
talking
Digital News
Is Andy Murray hanging up his racket for a career in medical devices?
POINT
I
t looks like Andy Murray may have a new doubles partner. The Wimbledon champion is teaming up with Scotland’s Digital Health & Care Institute to promote the way technology can be used to benefit health. Murray said: “My partnership with the Digital Health & Care Institute has come about because I am really interested in how digital technologies can improve health. “I obviously have a personal interest in that area because anything that can improve my own health will only improve my performance on court.” This is a positive move to help boost the digital medical device market. Thanks to Murray’s interest in digital technologies to improve and monitor health and wellbeing, and with his recent experiences of working with start-up companies in the health, sport and wearable technology markets, Murray’s philanthropic involvement will raise awareness of the sector. Murray is a huge supporter of technology and data to improve his performance on
court and has revealed that maintaining his own health throughout the long tennis season is key to his success. As such, he is well positioned to champion the digital health message and his global popularity will help take the DHI brand and the work they do to a wider audience.
DIGITAL SPY
Tweets with character In a few more than 140 characters MPN elaborates on one of its most popular tweets from the past month
Photo: Wachiwit / Shutterstock.com
The tweet: BREAKING: wild #Pokémon discovered in the life science sector! @ PlymSciencePark
What’s the story? Everyone’s been writing, blogging, tweeting and talking about the Pokémon Go phenomenon, and we’re no different. With at least one member of the Medical Plastics News team demonstrating a major penchant for Pikachu, we knew there had to be a story in it for us. That’s why we were excited when a UK science park got in touch to let us know that wild Pokémon had been spotted on-site at the facility, which is home to a number of life science brands. Plymouth Science Park on Britain’s south coast explained that the site, whose
residents include heart health tech firm Cardio Analytics, is home to a number of ‘Electabuzz’ - an electrically charged creature with lightningfast reactions. In case you’ve made it to the end of this and have no idea what Pokémon Go is, it’s a free locationbased reality game app, which allows players to capture, battle and train virtual Pokémon (an abbreviation of pocket monsters - a Japanese collectible craze) which appear throughout the real world. Interestingly, Pokémon Go has been credited for its potential in the digital health space head over to our partner site DigitalHealthAge. com to read more.
WWW.MEDICALPLASTICSNEWS.COM
comfortably numb: Spine-finding device improves epidurals The Accuro device helps anaesthetists with spinal needle placement What is it? A spine-finding device to revolutionise epidurals. Thanks to the work of two former University of Virginia students, guesswork in needle placement for epidurals and spinal anaesthesia could become a thing of the past. “Epidurals and spinals should be guided with medical imaging and shouldn’t be done blind,” said Will Mauldin, co-founder of Rivanna Medical. Mauldin and Kevin Owen created the Accuro device which uses ultrasound to determine the best entry points on the spinal column and guide anaesthetic needles. Why is it unique? This is said to be the world’s first ultrasound system to help the application of spinal anaesthesia using automated detection of the epidural location and depth. Mauldin and Owen founded Rivanna Medical in 2010 and received FDA approval to sell it to hospitals in November. “Accuro lets you find the midline on the spine and tells you how deep the anatomy is. With it, you can find a vertebra that looks better than another if you need to,” Owen said. “Some people have calcifications and other things like scoliosis that might make it hard to get the needle into a particular area.” How does it work? Accuro provides digital overlays that identify what the user is seeing in the ultrasound image and offers a 3D navigator that pinpoints the best place for insertion along the patient’s spine. It also includes a needle guide that will mark the skin with a bullseye or that can be used in real-time to place the needle while the device is in use, depending on the user’s preference. www.news.virginia.edu/content/alumnirevolutionize-epidurals-new-spine-finding-device
9
NEWS FOCUS
Evonik leads the way in next generation OF BIODEGRADABLE POLYMERS FOR IMPLANTS
E
vonik is carrying out research into biodegradable highstrength composites which could replace metal in implants used for internally repairing fractured bones. Implants play a key role in supporting bones until they heal. Metallic devices typically Work by Evonik remain in the body for the rest of the patient’s on biodegradable life or require additional surgery for removal. By contrast says Evonik, bioreabsorbable composite materials devices made with its new composites will could replace metal in be absorbed by the body gradually once implants designed for the bone healing process has taken place. repairing fractured These materials consist of polymers and of substances that naturally occur in bones.
bones as well as offering surgical benefits to patients
Evonik’s research is still in its early stages – however, the possible benefits for patients are already clear. Patients will no longer need to undergo additional surgical procedures to remove the implanted devices. Specific device designs may also help bones regenerate faster. The project is one of a number currently being conducted at the Medical Devices Project House in Birmingham, Alabama, USA, which employs a team of more than 20 experts. Its mission is to develop new medical technology solutions and materials – with a particular emphasis on implants. Dr Andreas Karau, head of the Project House, explained the researchers’ vision: “In the long term, our focus is regenerative medicine. We want to create bioabsorbable implants to replace damaged tissues with healthy tissues. Our current work on biodegradable composites is a first step in this direction.” There is a significant need for high-strength biodegradable materials. The number of implants required for the fixation of bone fractures is substantial: osteoporosis, for example, is responsible for 8.9 million fractures every year. Additionally, the 300 billion global medical technology market is growing at around 6% annually. The USA commands the largest share of the global market by far, with 40%. Moreover, American companies are major players in implant technology. Other key medical technology markets include Europe and Japan. “Our leading position in polylactic acid-based polymers is an excellent foundation for the development of materials and solutions for regenerative medicine,” explained Karau. The polymers break down into carbon dioxide and water. Degradation time depends on their molecular composition, chain length, and crystallinity. They can last from a few weeks to many months – providing plenty of time for bones or other tissues to regenerate. Medical device manufacturers use Resomer polymers marketed by Evonik’s Health Care business to make bioabsorbable screws, pins and small plates. These are primarily used for torn ligaments in the knee or shoulder, and for fixation of smaller bones in fingers or the face. However, as Karau noted: “At the moment, the materials we have available are not strong enough to be used for large, load-bearing bones.”
Now you see it: Implants made with Evonik’s new composites will be absorbed by the body gradually once the bone healing process has taken place
Consequently, the researchers at Medical Devices Project House are exploring composite materials that reinforce biodegradable polymers with inorganic substances, such as derivatives of calcium phosphate. Not only do these additives strengthen the material, they enhance its biocompatibility. “As the polymers gradually break down, calcium and phosphate can be absorbed into the newly formed bone tissue,” Karau added. The researchers’ vision goes further. With the right materials, they could harness 3D printing to create made-to-measure implants for individual patients. One of the goals of Evonik’s researchers in Birmingham is to make its biodegradable polymers suitable for this additive manufacturing process. Karau said: “In the long term, we intend to develop polymeric scaffolds that could be colonised with living cells – creating a true biological implant.” This approach would make it possible to regenerate cartilage, for example – or to replace damaged heart tissue with healthy tissue. However, the researchers must first find ways to improve the materials’ biocompatibility. The scientific experts in Birmingham are part of Creavis, Evonik’s strategic innovation unit, and work hand-inglove with polymer specialists from Health Care and Performance Materials. The team at the Project House is also investigating biocompatible plastics, used in Evonik’s Vestakeep implant product line.
Evonik ’s work on biodegradable composite materials could replace metal in implants designed for repairing fractured bones
POLYMERS VELOX EXPERTISE
O p e ra t i o n
WE UNDERSTAND MEDICAL
f u t u r e
In the next 10 years nano- and microrobots equipped with chemical motors or nanoparticle sensors will be navigating their way through the human body. Water-soluble plastics will
• Raw materials supplier
deliver and release medicines. Or it will be possible to print
• Small quantities just in time
scoliosis corsets in plastic with the help of 3D scans. Operation future starts directly at K 2016. In 19 exhibition halls with 3,200
• Technical advice at design stage • Change management • Regulatory support
exhibitors on more than 171,000 sqm of exhibition space. With the entire global offering of the plastics and rubber industry. Plan your visit now.
Passion for Performance
• Customised polymer solutions
VELOX GmbH +49 (0)40 369 688 0 medical@velox.com Messe Düsseldorf GmbH P.O. Box 10 10 06 40001 Düsseldorf _ Germany Tel. + 49 (0)2 11/45 60-01 Fax + 49 (0)2 11/45 60-6 68
www.velox.com k-online.com
1 W W W . M E D I C A L P Lkmd1602_Medizin_86x266_INT.indd ASTICSNEWS.COM
www.messe-duesseldorf.de
15.07.16 10:2511
NEWS FOCUS
Inspex returns to TCT Show ON 28-29 SEPTEMBER, NEC, BIRMINGHAM THIS YEAR’S
TCT SHOW + PERSONALIZE 2016
WILL FEATURE THE COMEBACK OF THE INSPEX EVENT
I
f you can’t measure it, you can’t make it — a fact that is as true for additive manufacturing and 3D printing as it is for milling, moulding and other conventional manufacturing techniques. At this year’s TCT Show + Personalize organiser, Rapid News Publications, will reintroduce the Inspex brand to the UK market and further accelerate awareness of the challenges and opportunities for metrology and inspection within the 3D manufacturing industry. Rapid News acquired the Inspex brand buying the Interplas trade show in 2014 and is bringing the brand back to market to focus on metrology and inspection technologies at the TCT show. For the 2016 show providers of metrology and inspection hardware, software and services will benefit from a targetted Inspex marketing initiative, including show planner, show preview, on-site guide and show maps. The metrology and inspection industry has always demonstrated a strong presence at TCT Show with attendance from leading companies such as Nikon, Renishaw, Europac, Olympus, and Central Scanning. However the importance of these suppliers on the success of precision machining processes or additive manufacturing (AM) in improving quality, reducing scrap rates and enhancing environmental sustainability is now greater than ever. The Inspex theme at TCT will bring these important technologies to the fore and the spotlight will make it easier for visitors to find the solutions they need. There will be a dedicated Inspex seminar session highlighting the latest technology along with real-world applications.
Head of content at TCT Show + Personalize, Jim Woodcock, commented: “The re-introduction of the Inspex brand signposts our intent to bring metrology and inspection to the fore as advances in manufacturing technology continue. TCT’s core focus has been on additive technologies since we started covering rapid prototyping in the 1990s and as these technologies mature the role of supporting and enabling technologies becomes more prominent. 3D design, manufacture and metrology must work together as part of a chain to get the most out of today’s technologies.”
There will be a dedicated Inspex seminar session highlighting the latest technology along with real-world applications
12
International exhibition and conference on the next generation of manufacturing technologies
Frankfurt, Germany, 15 – 18 November 2016 formnext.com
50° 6‘ 36.128‘‘ N 8° 38‘ 54.529‘‘ E Experience the next generation of intelligent industrial production. From design through to serial production. Visit formnext with its unique combination of additive and conventional manufacturing technologies. Be inspired.
Where ideas take shape.
Exhibition Movie
formnext.com/movie
Information: +49 711 61946-825 formnext@mesago.com
Follow us
@ formnext_expo # formnext16
NEWS ANALYSIS
BIOACTIVE FILM improves how implants
bond with bone New research has led to the development of a biofilm which could mean an improved success rate for implants and the surrounding bone
R
esearchers at North Carolina State University, the University of Cambridge and the University of Texas at San Antonio have developed a technique for coating polymer implants with a bioactive film that significantly increases bonding between the implant and surrounding bone in an animal model. It is thought that the advance could significantly improve the success rate of such implants which are often used in spinal surgeries. The polymer in question polyether ether ketone (PEEK) has mechanical properties similar to bone, making it attractive for use in spinal implants. However, it doesn’t bond well with bone. Researchers had previously developed a technique for coating PEEK with hydroxyapatite (HA), a calcium phosphate that bonds well with bone. In 2013 North Carolina State University (NC State) reported that proof-of-concept studies were promising but researchers were then only able to apply the HA coating to flat surfaces and had not tested HAcoated implants in an animal model. “We can now use our technique to coat the entire surface of an implant, and testing HA-coated implants in an animal model has given us very promising results,” said Afsaneh Rabiei, a professor of mechanical and aerospace engineering at NC State and corresponding author of a paper on the work. The first step of the HA-coating technique – which was developed in Rabiei’s lab – coats a PEEK implant with a thin film of yttria-stabilised zirconia (YSZ). The second step applies a coating of HA. The researchers then heat the HA layer using microwaves. The YSZ layer acts as a heat shield, preventing the PEEK from melting. Meanwhile, the heat gives the HA a crystalline structure that makes it more stable in the body, meaning that the calcium phosphate will dissolve more slowly – promoting bonding with surrounding bone. In their new study, researchers tested three types of PEEK implants in a rabbit model: PEEK implants with no coating; PEEK implants with an HA coating treated only with microwaves; and PEEK implants with an HA coating treated with both microwaves and brief exposure to an autoclave in order to enhance the HA’s crystalline structure.
14
WWW.MEDICALPLASTICSNEWS.COM
NEWS ANALYSIS
The researchers used microscopic evaluations of tissue cells and three-dimensional X-ray imaging to assess the performance of all three types of implants. Eighteen weeks after surgery, the researchers found that both types of HA-coated implants had more than double the bone formation of PEEK alone, with comparable bone density. The HA-treated implants also had higher boneto-implant contact ratios than PEEK alone. “These results indicated an improved implant fixation in the body, decreasing the chances of loosening of the implant after surgery and the need for revision surgery to remove and replace the implant,” Rabiei said. “This improvement is due to increased regenerated bone volume around coated implants compared to uncoated PEEK.” The researchers also did biomechanical testing on the implants, assessing their ‘toughness’ or how well the implant bonded to the surrounding bone. To test this, the researchers conducted what is called biomechanical push-out testing, in which force is applied to an implant until it is dislodged. These results are measured in terms of work as Newton millimetres (N-mm). At 18 weeks, it took approximately 299.1 N-mm of work to dislodge implants coated with microwavetreated HA and about 312.5 N-mm to dislodge implants coated with microwave and autoclave-treated HA. This compares with about 183.9 N-mm of work needed to dislodge unmodified PEEK implants. “It is notable that these results were achieved on completely smooth surfaces of PEEK, while our subsequent studies have indicated that by slightly increasing the surface roughness of PEEK prior to coating, we can accomplish even higher adhesion strength of two-layer HA/YSZ coatings that would require even higher work to dislodge,” Rabiei said. Histological evaluation of bone growth against the non-coated PEEK implants (A and B) and coated PEEK implant using ion beam assisted deposition followed by the microwave heat treatment and a final autoclaving (E and F) after 18 weeks of implantation in a rabbit model. The new bone in contact with the implant surface appeared to be much thinner in the uncoated PEEK group at 18 weeks (B) compared with the new bone formed in contact with the (F) coated implants at the same time. White arrow points at ossified (Indicating new bone formation) and yellow arrow points at the fibrous tissue (indicating scar-like tissue), implant marked by ‘I’.
“Whether looking at bone growth or toughness, HA-coated samples outperformed uncoated PEEK implants,” Rabiei says. “This treatment will probably increase the cost of an implant marginally, but should help minimize the need for follow-up surgeries – which means HA-treated implants will more than pay for themselves over time.” “And the extent of the cost increase remains unclear,” Rabiei adds. “We are not aware of any health risks associated with HA or YSZ – both of which are used in devices already approved by the FDA for long-term implantation. As a result, we may not need additional clinical trials before HA-coated implants can be used in clinical practice. We’re investigating that now, and are looking for industry partners to help us commercialise the technique.” The paper, “Hydroxyapatite coating on PEEK implants: biomechanical and histological study in a rabbit model,” is published online in the journal Materials Science and Engineering C.
WWW.MEDICALPLASTICSNEWS.COM
15
INNOVATING TOGETHER
Freudenberg Medical is a global partner for the design, development and manufacture of innovative medical device technologies. Our comprehensive technical capabilities range from the design and manufacture of minimally invasive, catheter, and handheld technology to the development and production of medical components utilizing complex materials and processes. We are leading the way in manufacturing high precision silicone and
thermoplastic components and tubing as well as metal hypotubes. Freudenberg Medical is part of the Freudenberg Group, a global 165-year old technology group that develops innovative products and services for more than 30 market segments worldwide. As an organization, we ensure that every project is supported by our unmatched range of global resources, financial stability, and the flexibility to optimize for business performance.
www.freudenbergmedical.com
freudenbergADA4branding190x124.indd 1
Ultrasonic welding technology. For medical applications.
3/14/16 11:24
Herrmann Ultraschall is a technology leader for machines, systems, and components for ultrasonic welding of plastics, packaging material, and nonwovens. Ultrasonic welding means joining without adhesives or screws, and without external heat supply. During this process, plastics are strategically melted by means of ultrasonic vibrations so that a cohesive or form-fit joint is produced. Core appli appliconneccations in the medical sector are membranes, adapters and connec tors, fluid containers, surgical instruments, blood filters, disposable packaging, masks, wound dressings, and patches. Through their Ameheadquarters in Karlsbad and the Tech Centers in Europe, the Ame ricas, and Asia, the machine builder ensures global presence and local service for their customers. Critical product and process re requirements are realized with technology from Herrmann Ultraschall: High strength Surfaces with impeccable visual appearance Reliable functionality of components Hermetic seal Prevention of particle flash Product safety due to cold sealing tools No adhesives or additives Statistical process monitoring Process data acquisition and analysis User authentifi cation and audit trails Feasible for clean room applications
Herrmann Ultraschalltechnik GmbH & Co. KG DescostraĂ&#x;e 3-9 ¡ D-76307 Karlsbad ¡ Phone +49 7248 79-0
www.herrmannultraschall.com
OPINION
The model answer H
ealthcare service providers across the globe are facing universal pressures; costs are rising due to a growing range of services and at the same time, they are seeing greater demand due to an increase in life expectancy while ongoing Darren Cooper, austerity is leading to budgets becoming Stibo Systems, ever tighter.
explains how the product-as-a-service model is disrupting the medical device market
While the solution to full wards might once have been to build more hospitals to accommodate more patients, healthcare providers must now examine the efficiencies of their established processes. Consideration must now be given to more nimble and creative solutions, how less invasive surgical procedures can cut down the length of hospital stays for instance, or how funding lifelong health and nutrition education can help reduce the risks of falling ill in the first place.
The advent of product-as-a-service One recent, technology-driven innovation – product-as-aservice – can not only help healthcare providers cut costs but also improve the services they offer patients.
cities. And GE, the aircraft engine manufacturer, offers flight efficiency and analytics services to help optimise flight procedures. In using these services, Alitalia, the Italian carrier, has saved 34m in fuel costs since the programme began in 2011. In the context of healthcare, a product-as-a-service agreement would see healthcare providers contracting with their medical equipment manufacturing suppliers to fulfil a service, such as 24-hour heart monitoring. The manufacturer would then provide the physical device and its lifetime maintenance, along with the cloud-based service to which it connects, and the capture and analysis of the data the device generates. If the patient or hospital had bought this device, they would have needed to pay for repair or replacement had it become worn out or obsolete. However, as with the car club example, the fact that they’ve bought the service means this needn’t be a concern. For as long as their agreement continues, they’ll receive the most up-to-date monitoring and analysis services from the best technology available.
Rather than buying an object or product, the model involves paying for an end result or service. Take for example, a car club in which customers pay a monthly fee for a vehicle that suits their needs; a van for moving furniture or a car for a weekend break, as and when required. Customers don’t pay for tax or insurance and they don’t need to worry about breakdowns, MOTs or servicing; all they pay is an agreed fee on an ongoing monthly basis for the productas-a-service. Elsewhere, Daimler and BMW not only sell cars as products but also provide them as part of a car sharing service. Since BMW started its DriveNow joint venture with Sixt in 2011, it now has 580,000 registered customers and operates across with 4,000 vehicles across nine European
WWW.MEDICALPLASTICSNEWS.COM
17
When Material Excellence Matters - Globally. Supplier of Medical Polymer Compounds to our Global Customer Base since 2008.
www.i-p-c.ie
OPINION
Combination of technologies
Effective data management underpins all of this.
This model is made possible due to the emergence of the Internet of Things (IoT) and the work of companies such as Philips Healthcare in developing devices that use IoT technology; embedding standardised, mass-produced microchips in every device to allow them to communicate with other devices across various internal and external networks.
Knowing which components have gone into which device, for example, will allow manufacturers to isolate production batches should an issue arise, avoiding costly recalls.
While still some years from becoming fully mainstream, the IoT will radically streamline and simplify the healthcare industry’s supply chain. Smart warehouses will directly monitor their stock levels, hospitals will check the status and location of their inventory in real time and monitoring devices, such as those previously mentioned, will supply a constant stream of data for analysis without the need for patients to take up valuable bed space and the most valuable of resources, time. The subsequent reduction in outpatient numbers, and the easing of resource levels brought about by continuous, pro-active monitoring, will both represent significant cost savings to the healthcare provider. For now, as a result of embeddable technology, connected to cloud-based systems by a universally available highspeed network, and supported by Big Data analytics solutions interpreting the constant flow of information, the healthcare industry is already starting to see the benefits of a fledgling product-as-a-service model. In time, this combination of technologies is set to relieve pressure on healthcare providers by increasing efficiencies in their daily routines, providing patients with the information they need on their own situations, enabling them to make decisions about and manage their care options, reducing the length of stays in hospitals.
Over the next few years, various necessary technical components will become more established and more patients will purchase their own devices, requiring the provision of monitoring services by manufacturers or third parties, Product-as-a-service is set to become a viable and cost-effective means of delivering healthcare, easing the pressure on an already over-stretched medical infrastructure. However, for it to fully succeed, it’s crucial for service providers to put robust and effective data management measures in place. Only by doing so can they hope to improve patient safety, and comply with existing and upcoming regulations, ensuring the security of their data while tracking and analysing it now and in the future, in the age of the IoT.
Service industry: According to Darren Cooper, the product-as-a-service model has been made possible thanks to the emergence of the Internet of Things and the work of companies such as Philips Healthcare
Effective data management While the benefits of smart, wearable medical devices to healthcare services are clear, the risks associated with their increasing use are only likely to become more acute, as illustrated by stories of external agents being able to hack into and control networked medical devices, such as infusion pumps delivering dosed medication directly into patients, It’s crucial that the vast amount of data generated by the embedded technology and communicated via the IoT concept is properly processed if the product-as-a-service model is to work effectively. Monitored data, for example, must be transferred quickly and accurately otherwise it could lose its value and even put a patient at risk. By not storing this data correctly and securely, healthcare providers may find themselves unable to analyse it effectively and run the risk of breaching regulations around patient confidentiality. And, as the product-as-a-service market grows, with more patients monitoring their own health, so the need for greater traceability and governance of the devices on which they rely grows too. Uniquely identifying each device from its point of manufacture through to its disposal is essential for healthcare service providers and manufacturers alike, supporting them in clinical trials and in complying with unique device identifier (UDI) regulations.
WWW.MEDICALPLASTICSNEWS.COM
19
Pump up the volume: Prefillable syringes are manufactured from COC in large numbers. Engel coinjection technology has made it possible to also produce gas-tight pharmaceutical packaging due to cheaper polypropylene (Picture: Hekuma)
COVER STORY
MAKING ADVANCES P
lastic packaging is light, safe in use, easy to functionalise and can be manufactured efficiently. The pharmaceutical industry is therefore also making increasing use of polymers in the production of containers, vials and applicators. Innovative technologies Christoph Lhota, Engel make it possible to combine the Medical, outlines the positive properties of the material way in which innovative with the strictest demands for product protection. Polymers are technologies are paving also increasingly being used as drug the way for efficient carriers for specific dose delivery pharmaceutical packaging directly in the body.
and drug carriers
For a long time there was no better material than glass for the packaging and storage of parenteral drugs. It has outstanding barrier properties guaranteeing reliable protection of products. The downside: – glass breaks easily, is heavy and cannot be formed into any shape without problem. Ongoing advances by material manufacturers are however, now accelerating the substitution of glass by plastics. Crystal-clear cyclic polyolefins and copolyolefins (COP and COC) not only also offer high transparency, high drug compatibility and gas tightness but are also breakproof, light and can be worked into very complex shapes. Prefillable syringes are for example, manufactured from COC in high numbers today. The advantages over glass predominate, even though the material is expensive and needs to be processed under inert gas.
simultaneously by combining inexpensive PP with gastight ethylene vinyl alcohol copolymer (EVOH). Food containers ready for filling are produced by an allelectric Engel e-motion injection moulding machine using Engel coinjection technology. Three layers of material are created in a one-shot process. The EVOH forms the middle layer and is enclosed completely by PP. The shelf life of foods packed in these containers is extended many times over due to reliable exclusion of oxygen and moisture. Thanks to the sandwich structure, only very little of the barrier material is needed, while the cheap thermoplastic lends the packaging its stability. The middle layer measures just 0.05mm, which corresponds to about a tenth of the total wall thickness. The integrated injection moulding process also has a positive effect on the overall balance of production. Beginning with the raw materials and a bonding agent, usable, functionalised containers are manufactured in only one step. The all-plastic packaging with a barrier film is therefore well superior to coated glass or metal containers.
Engel already took the requirements of the new GAMP 5 into consideration during development of the new CC300 control unit generation. (Picture: Engel)
Coinjection: Food containers serve as an example Growing pressure in the pharmaceutical industry to keep costs down is moving the focus to an alternative to COC – polypropylene (PP). Large quantities of PP are already being used in the medical industry to manufacture disposable syringes and infusion sets. The material is accepted by the industry and offered with medical-grade specification by many manufacturers. The problem is it has poor barrier properties. Manufacturers of food packaging are exposed to higher cost pressures than pharmaceutical companies, although they often have to meet similarly strict hygiene requirements. They meet both these demands 20
WWW.MEDICALPLASTICSNEWS.COM
COVER STORY
Using injection moulding, it is possible to produce tablets with delayed release of the active ingredient. The chart on the left shows the release profile of compounded micropellets and the chart on the right that of injection-moulded tablets – each with a drug load of 10, 20 and 30 percent. (Picture: Engel, measurement results: RCPE, Graz/Austria)
Tablets from injection moulding machines Apart from higher processing efficiency, more safety and lower unit costs, polymer materials open up other opportunities to the pharmaceutical industry, for example as drug carriers. Around 40% of all drug developments do not dissolve well in water. For an active ingredient to reach its target from a solid form of oral administration and be absorbed there, it must first dissolve. To improve solubility, the latest move is to manufacture solid dispersions. The active ingredient is embedded in these in a matrix of a water-soluble polymer serving as excipient and solubiliser. Solid dispersions are manufactured nowadays by hot-melt extrusion in a multistep compounding process. The extrudate is first pelletised before the pellets are ground again and passed on in the next step to a tablet pressing line. Along with partners Engel has been involved in the development of principles for the injection moulding of pharmaceutical dosage forms. For the research work, a polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer was used as base material and fenofibrate, a lipid reducer classified as having poor solubility in water. Tablets with a diameter of 13mm and a height of 4mm were manufactured from this polymer-active ingredient system. The tablets were shaped in a mould with six cavities and a naturally balanced star-shaped runner system in conjunction with a sprue gate in an all-electric Engel e-mac 50 injection moulding machine. When plastics are pigmented, the aim is to obtain uniform distribution of the pigments over the surface of the component, for which the complete plastic melt is pigmented during plasticising. In the case of pharmaceutical dosage forms, uniform distribution of the active ingredients over the complete height of the tablets is not only desirable, but essential. Overall the research results clearly show that injection moulding technology harbours interesting potentials for improvements in efficiency and quality in the production of pharmaceutical dosage forms. It is possible, for example, to produce tablets with delayed release of the active ingredient. A further advantage is that, in contrast to tablets pressed from powder, it is possible to shape injection-moulded tablets completely freely in any geometrical form. Initial mould and injection moulding machine concepts have already been developed to implement these research results in large-scale pharmaceutical production. They are based on a mould with 128 cavities and a target output of 200,000 tablets per hour.
Vaginal rings for hormonal contraception have already reached the market. The still new dosage form will be used for other indications as well in the future. (Picture: Engel)
Plastics-based drug carriers reach the market To supply the body with defined doses of an active ingredient automatically over a longer period of time, implants or other polymer-based dosage forms such as vaginal rings will be used increasingly in the future. A manufacturer in southern Austria plans to start serial production of contraceptive products this year. This is the result of a research project and Engel was involved in the development project from its inception. The rings are manufactured by all-electric Engel e-motion injection moulding machines.
Maximum performance in cleanrooms Material developers have not alone been instrumental in accelerating the use of plastics in the medical technology and pharmaceutical industries. Machine manufacturers have also played a role by establishing the prerequisites for this. Engel for example, has designed its all-electric Engel e-motion injection moulding machine systematically for high-performance operation and use in cleanrooms. Cleanroom versions of the machines are offered across the complete clamping force range up to 5,000 kN. In this way ENGEL meets the demands for increased use of multicavity moulds in GMP environments.
New GAMP 5 fulfilled completely Engel’s medical business unit works closely together with developers. In this way Engel accounts for the specific requirements of users in the medical technology and pharmaceutical industries from the beginning. One example of this is the control unit generation CC300, which meets the requirements of the new GAMP 5 in full. Whereas GAMP 4 still classified the control system as firmware, GAMP 5 requires validation of all software solutions. The control units for injection moulding machines fall in software category 3, which means that the requirements from the specification book must be evaluated with the help of an FMEA and implemented on the basis of these results. Apart from the risk assessment, GAMP 5-compliant documentation comprises the validation master plan and change management. The complete lifecycle model of the CC300 control unit therefore corresponds to GAMP 5 requirements.
WWW.MEDICALPLASTICSNEWS.COM
21
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
ANTIMICROBIALS
on point Cikautxo Medical outlines the latest developments in vascular access devices and antimicrobial trends
T
he European Vascular Access Catheter market has been affected in the last years by some main trends, one of them related to the alternatives that the PICC and midline catheters offer as a substitution to conventional CVC catheters and other one related to the increasing use of antimicrobial and antithrombogenic performances on the catheters to reduce risks of infections and thrombus in patients.
Vascular access catheter trends In comparison to CVCs, PICC insertions are less invasive with decreased complication risk and the PICC can remain indwelling for a longer duration than other acute central or periphery access devices.
Central venous catheters (CVC), due to its point of insertion, is certainly uncomfortable for the patient and is additionally exposed to some risks of infection and thrombus.
Peripherally inserted central catheters are used to obtain central venous access in patients undergoing treatment in acute care facilities, home health agencies, cancer centers and skilled nursing care in a variety of settings. PICC typical indications are long-term chemotherapy, hyper-alimentation, antibiotic therapy, repeated infusion of blood or blood products, venous blood sampling, reduced number of needle punctures to skin and measurement of central venous pressure among others. The PICC is usually placed today using an ultrasound technology to visualise a deep, large vessel in the upper arm and it is inserted by a specially trained and certified PICC nurse specialist or interventional radiologist. After the insertion, a chest x-ray can be obtained to confirm the correct placement. The entire procedure can be done in a patient’s room decreasing discomfort, transportation and inefficiencies of nursing care. Ultrasound placement has been demonstrated to reduce the number of punctures per patient during insertion. The use of ultrasound is of greatest importance with those patients that are most difficult to insert (eg obese patients).
Based on this advantage of the peripheral insertion, a new family of catheters is appearing as an alternative to PICCs in those cases where the tip of the catheter can remain peripheral and does not need to go central: the midline catheters (see table on the following page).
Antimicrobial & antithrombogenic trends It is also well known that vascular access catheters are exposed to a risk factor of biofilm growth and in those cases, infections may sometimes occur causing an extra damage to patients and causing extra costs to hospitals. For this reason, in the US market, approximately two third parts of the catheters purchased have some antimicrobial and/or anti-thrombogenic performance. Europe today does not have the same legislation but some European hospitals have made their balance and have started to increase the percentage of catheters purchased with those performances. There are different methods to kill bacteria, which generally consist of the addition of a substance to the catheter. Once this is placed inside the patient it attacks bacteria growing colony (biofilm) being created on the catheter surface.
As per expert sources reports, PICCs are expected to grow significantly in Europe in the next following years (see graph)
For non-irritant treatments and longer periods of insertion there is another alternative more comfortable and safer for the patient: the peripherally inserted central catheter (PICC). 23
Specialist Kit Components Custom Made for You Does your new product need bespoke plastic kit components? We can help with our personalised, flexible, fast custom-design service for:
PastetteÂŽ Disposable transfer pipettes in any format Plate Seals For specific manufacturing and packaging requirements UN3373 Compliant Packaging: Custom designed kits for clinical trials packs
You define the specifications, size, branding and packaging.
Contact Alpha Laboratories for more information or a quotation for your OEM requirements and join our long list of satisfied customers. Visit www.alphalabs.co.uk, call +44 (0)23 8048 3000 or email marketing@alphalabs.co.uk
MPNs_Specialist-OEM-Requirements_Jul16.indd 1
24
19/07/2016 16:33:45
WWW.MEDICALPLASTICSNEWS.COM
ANTIMICROBIALS
DEVICE
Short PIVC
PRIMARY USE Provides short term (few days) access to peripheral veins to administer medication or fluids
INSERTION LOCATION
TIP PLACEMENT
Peripheral
Peripheral
CVC
To intravenously administer drugs and fluids and monitor central venous pressure
Central
Central
PICC
Primarily long-term (weeks to months), to intravenously administer drugs or fluids
Peripheral
Central
To intravenously administer drugs or fluids, not central but closer to bigger veins
Peripheral
Peripheral
Midline Catheter
There are catheters with different active substances, some of the best known being the silver ions, antibiotics and chlorhexidines. In some cases, the surface is treated with a non-leaching substance that kills the bacteria with no contact when it approaches to the catheter. This method does not release any substance along the vascular system of the patient and therefore less secondary effect may occur. Some European catheter manufacturers are offering effective antimicrobial and antithrombogenic catheters in the European market. This is the case of Cikautxo Medical, a Basque company specialist in silicone and thermoplastic catheter manufacturing (CVC, PICC, mid-lines ) in combination with value added solutions proposals.
CEO, Iker Principe says: “Our customers, the big catheter branded manufacturers, select some of our different technologies available in order to try to differentiate themselves in the market: some of them are giving priority to the time-to-market aspect and choose a simpler technology like silver ions which we manufacture embedded into the catheter tube and accept the release of a small (always under the regulatory limits) silver quantity into the vascular system. Some other customers prefer a longer term anti-microbial / anti-thrombogenic solutions based for example on chlorhexidine and accept the potential down sides of this second leaching method (perhaps a very remote allergic anaphylactic risk). Although we also have a solution based on a cocktail of antibiotics we do
not recommend them due to the tolerance that might cause in the patients and today we are focusing our efforts in new generation technologies, a non leaching ‘natural polymer’ antimicrobial coating. The natural polymer that is going to act as a ‘selective non-contact bacteria killer’ is linked into the catheter surface with a special surface activation treatment and once the complete process is finished, we post-cure the catheters to delete any possible volatile agent. The bacteria attack is made by a technology called ‘positive charge’ and it is an ionisation killing activity that emits no leaching substance into the vascular system.”
There are different methods to kill bacteria, which generally consist of the addition of a substance to the catheter. Once this is placed inside the patient it attacks bacteria growing colony (biofilm) being created on the catheter surface
A midline catheter positions the tip of the catheter in the clavicular vein area and for this reason are not considered central venous catheters, opening the possibilities of insertion to a wider range profile of medical qualified human resources. This advantage opens an excellent cost saving opportunity for hospital management. Today different varieties of midlines are being launched in the market, like the mid-clavicular, the short-midlines, others. WWW.MEDICALPLASTICSNEWS.COM
25
NOW HERE’S A NEW INJECTION OF INTELLIGENCE
Accurate and reliable temperature control solutions for your chemical and pharmaceutical manufacturing processes for sale or hire.
SALES: 0800 774 7415 HIRE: 0800 840 4210 info@icscoolenergy.com T HE TE M PE RATU RE CO N T R O L S P EC IAL IS T S. SALES. HIRE. SERVICE.
WW W.I CS CO O L E N E R GY.COM
CATHETERS
Matter in hand Henniker explains how plasma can aid catheter manufacture
C
atheter function and patient health rely on strict material biocompatibility in order to prevent pathogen introduction and propagation and to reduce instances of associated urological and vascular problems. Plasma surface modification is proving to be a reliable and effective method for treating various component materials, and also finished Plasmas quite devices, in order to minimise the potentially harmful side effects of catheter use. rightly are often
referred to as the of
Plasmas can be tailored to deliver surface fourth state properties including anti-fouling, antimatter microbial and increased lubricity amongst others. They can achieve a range of desirable properties either directly – by polymeric deposition – or indirectly, by introducing intermediate functional layers prior to application of a final surface finish or coating. Plasmas are not a lab curiosity. Plasma technology has been an important production tool for more than 30 years in the fabrication of microelectronic devices for example. Over this period, plasma technology has also permeated a much broader range of industries. It’s useful to define what a plasma is. Solid, liquid and gas are the three states of matter we are all familiar with. We can move between the states by adding or removing energy (eg heating/cooling). If we continue to add enough energy, gas molecules will become ionised (lose one or more electrons) and so carry a net positive charge. If enough molecules are ionised to effect the overall electrical characteristics of the gas the result is called a plasma. Plasmas are therefore quite rightly, often referred to as the fourth state of matter. A plasma contains positive ions, electrons, neutral gas atoms or molecules, UV light and also excited gas atoms and molecules, which can carry a large amount of internal energy (plasmas glow because light is emitted as these excited neutral particles relax to a lower energy state). All of these components can interact with the surface during plasma treatment. By choosing the gas mixture, power, pressure etc we can quite precisely tune, or specify, the effects of the plasma treatment.
Plasma surface activation renders many polymers receptive to other coatings
Many polymers used in catheter manufacture are chemically inert and cannot bond easily to other materials, displaying poor adhesion with inks, paint and glues. The reason for this is the absence of polar and reactive functional groups in their structure. Plasma surface activation renders many polymers receptive to other coatings. Oxygen is usually used as the process gas, however, many plasma activations can also be carried out with just ambient air. Typical results for PU catheter materials that were modified by plasma treatment and then heparin coated revealed little or no protein binding after 30 days indwelling for example. In another example, hydrogel adhesion and friction reduction improvement figures up to 70% have been achieved by plasma treatment.
Tech talk: Plasma technology has been an important production tool for more than 30 years in microelectronic devices for example
WWW.MEDICALPLASTICSNEWS.COM
27
倀爀漀搀甀挀椀渀最 戀攀猀瀀漀欀攀 氀漀挀愀氀椀猀攀搀 挀氀攀愀渀 愀椀爀 猀漀氀甀琀椀漀渀猀 䈀礀 瀀氀愀挀椀渀最 琀栀攀 洀漀戀椀氀攀Ⰰ 愀搀樀甀猀琀愀戀氀攀 甀渀椀琀 搀椀爀攀挀琀氀礀 漀瘀攀爀 琀栀攀 挀爀椀琀椀挀愀氀 愀爀攀愀Ⰰ 挀漀渀琀愀洀椀渀愀琀椀漀渀 椀猀 挀漀渀琀爀漀氀氀攀搀 眀栀椀氀猀琀 攀渀猀甀爀椀渀最 洀椀渀椀洀愀氀 搀椀猀爀甀瀀琀椀漀渀 琀漀 礀漀甀爀 攀砀椀猀琀椀渀最 戀甀猀椀渀攀猀猀 瀀爀漀挀攀猀猀攀猀⸀ 圀栀攀渀 礀漀甀 栀愀瘀攀 愀 瀀爀漀挀攀猀猀 琀栀愀琀 漀渀氀礀 爀攀焀甀椀爀攀猀 愀 氀漀挀愀氀椀猀攀搀 挀氀攀愀渀 愀椀爀 猀漀氀甀琀椀漀渀 愀渀搀 眀栀攀爀攀 昀甀氀氀 爀漀漀洀 挀漀瘀攀爀愀最攀 椀猀 渀漀琀 愀 爀攀焀甀椀爀攀洀攀渀琀Ⰰ 䠀䔀倀䄀ⴀ氀椀琀攀 挀愀渀 戀攀 搀攀猀椀最渀攀搀 愀猀 礀漀甀爀 挀愀渀 戀攀 搀 戀攀猀瀀漀欀攀 椀渀渀漀瘀愀琀椀瘀攀 猀漀氀甀琀椀漀渀⸀
挀漀渀琀愀挀琀 甀猀 䌀漀渀渀攀挀琀 ㈀ 䌀氀攀愀渀爀漀漀洀猀 䰀琀搀 刀椀瘀攀爀猀椀搀攀 䠀漀甀猀攀 䘀漀爀最攀 䰀愀渀攀 䰀愀渀挀愀猀琀攀爀 䰀䄀㈀ 㘀刀䠀 吀㨀 ⬀㐀㐀⠀ ⤀ 㔀㈀㐀 㠀㌀ ㈀ 愀 洀漀戀椀氀攀 愀搀樀甀猀琀愀戀氀攀 挀氀攀愀渀爀漀漀洀 甀渀椀琀
䔀㨀 椀渀昀漀䀀挀漀渀渀攀挀琀㈀挀氀攀愀渀爀漀漀洀猀⸀挀漀洀 圀㨀 眀眀眀⸀挀漀渀渀攀挀琀㈀挀氀攀愀渀爀漀漀洀猀⸀挀漀洀
吀攀氀氀 甀猀 礀漀甀ᤠ瘀攀 猀攀攀渀 甀猀 椀渀 䴀倀一
CATHETERS & STENTS
PUT TO THE TEST I
ncreasing regulatory pressure is challenging medical device manufacturers to meet strict requirements in design, testing, and production. This trend is reflected in catheter systems that are used for vascular surgery along with coronary stents.
Alan Thomas, Zwick Roell discusses catheter testing and how to address any challenges
There are many different types of catheters including those used to transport various small instruments or repair devices to a particular site in the body. Some catheters have small integrated tools to enable a surgeon to repair a problem in the patient’s body without having to perform open heart surgery. Other catheters deliver drugs directly to an infected area, while some can deploy a stent that will keep an artery open.
For surgeons, challenges associated with such procedures include feeding catheters into femoral arteries, navigating sharp turns and advancing the device without damaging surrounding tissue. Manufacturers of catheter systems work closely with surgeons to develop standard and custom catheters, stents, and guide-wires to meet these challenges. Catheter manufacturers continually monitor their product by physically testing the complete units, as well as individually testing the component parts. To effectively test such devices, catheter manufacturers need to replicate the condition of a patient lying on an operating table and a surgeon inserting a catheter. Meeting such needs requires a horizontal testing machine with a range of special adaptations to facilitate simulated operational procedures being carried out. Stents are tested both in compression and flexure modes and the frictional behaviour of the complete catheter is measured as it is pushed through a simulated artery known as a “tortuous path.”
Realistic test results can be obtained by using a specially adapted horizontal test machine
To facilitate this action, test equipment engineers at Zwick in Germany, have developed a system that controls the test machine crosshead and automated pneumatic grips. The horizontal machine is essentially a test bed that incorporates a workspace to accommodate 3-D models and water baths. Even large delivery devices can be mounted and tested throughout their full range of functionality.
In a typical test, the testing machine pushes the catheter into the tortuous path for a designated distance before the pneumatic grip, which replicates the hand of a surgeon, then releases the catheter and the crosshead moves back to the original start point. The pneumatic grips close onto the catheter and the crosshead moves forward once again. This sequence is repeated until the catheter has been fully inserted into the simulated artery. This test procedure, which is fully automated, can easily accommodate different configurations of tortuous paths and the machine software typically enables the following range of results to be calculated. Track force. Measures the force needed to advance a catheter, interventional device or guide wire through a tortuous path. Push efficiency. Uses the proximal and distal load cell to measure the amount of force the distal tip of the product sees when a known force is being applied to the product on the proximal end. Insertion force measurement. Measures the force used to advance through the introducer sheath. Guide-wire movement. Measures the force needed to advance a guide wire though catheter, guide catheter or other interventional device. Flexibility. Measure of a catheter tips ability to track over a specified bend in a guide wire, such as 90 degrees. Guide-wire and catheter lubricity track measurement. Comparative test using the track test data to determine if coatings affect the force required to advance product through a tortuous path. The results can be calculated with high precision, as the extremely stiff load frame with digital control, ensures that forces measured during the test originate from the sample under test and not from within the machine itself. The machine control system has such a high degree of accuracy and resolution that it can position the crosshead of the machine to less than 1m, and read forces to an accuracy of better than 0.5% down to values of less than 0.1mN/0.02lbsf. The machine software platform controls all of the test parameters including the safety features of the machine. At the same time, it can acquire and process the raw test data in real-time which is stored as individual data points and as calculated result data. A standard video camera to be connected to the system to record the test sequence and the incoming video signal is automatically synchronised with the force and displacement data. It allows a more complete record of the test to be saved or transmitted to interested third parties. Stringent regulatory environments require the ability to maintain accurate records of the testing procedures and results, and the software includes the functions ‘electronic records and signatures’ for complete digital documentation of all safety critical tests.
WWW.MEDICALPLASTICSNEWS.COM
29
HUMAN FACTORS ENGINEERING
I’M ONLY HUMAN W
e wouldn’t buy a product and accept the fact we couldn’t get it out of the box, hold it properly or find it awkward to store. If we invest in an upgraded vacuum cleaner for example, we assume we will be able unwrap it alone, that we can use the product easily and Designing a successful that it actually does what we bought it product is a complex for – vacuum.
process taking into account not only the final function of the device but a range of additional factors too, including its interaction with human beings, says Lu Rahman
Given the crucial, often life-saving role that medical devices play, it’s not surprising guidance exists on product usability to ensure safe and effective products reach the market. Of course we would expect a medical device to perform the function it has been designed for but other factors also come into play – the testing or manufacture of the product or how easy it is for a healthcare professional to remove the packaging when needed? How easy is the device to transport and does it lend itself to scale-up? Earlier this year the FDA updated its 2011 guidance on applying human factors engineering (HFE) to medical devices – manufacturers will therefore already be aware of its importance which aims to improve products and reduce errors. It examines how humans interact with devices – how a person’s cognitive and physical functions tie in and what the limitations of device design might be. Thanks to this FDA guidance medical device manufacturers are encouraged to focus on all points of interaction between the user and the device: “FDA is primarily concerned that devices are safe and effective for the intended users, uses, and use environments. The goal is to ensure that the device user interface has been designed such that use errors that occur during use of the device that could cause harm or degrade medical treatment are either eliminated or reduced to the extent possible,” says the FDA.
HFE is increasingly becoming a key issue for the sector. At this year’s Pharmapack in Paris, the topic was a key focus – the organiser recognised that for instance where combinations products are concerned, HFE along with design for manufacture (DFM) and design for assembly (DFA) are crucial to the success of this range of products. Phillips-Medisize has been considering this aspect of medical device production for some time. An integrated product development process combines human-centred ways of thinking with solid design for manufacturing (DFM) and design for assembly (DFA) philosophy, covering design research, industrial design and human factors engineering focussing on product usefulness, usability, desirability and manufacturability. Product design and development firm Cambridge Consultants has teamed up with medical device start-up WaveGuide Corporation on the development of a portable nuclear magnetic resonance (NMR) scanner to tackle TB. The new sputum test being developed is affordable and no bigger than a shoebox – so it can be used in mobile clinics, for example. It will give results in less than 30 minutes, with 95% accuracy. And it paves the way for detecting drug-resistant TB. This all means that appropriate treatment can be started promptly – improving patients’ chances of recovery. “We’re bringing the reliability of expensive, high-tech laboratory equipment to patients in the field, as well as in hospital, in the form of a compact POC device that gives accurate results fast,” said Richard Hall, head of global medical technology at Cambridge Consultants. “Our expertise in fluidics, electronics, mechanical engineering and connected health, together with our human factors skills, is enabling us to help WaveGuide create a truly innovative diagnostic device for emerging markets.” Ximedica is another business that recognises the value of human-centred engineering. Speaking to EE Times, the company’s Aidan Petrie, outlines how he helps maintain a lead in innovative medical device design using his experience working in medical device development. His aim is to “build a robust but nimble product development process within an FDA-regulated industry with a particular eye to usability and human factors.” Petrie tells the magazine how the company operates: “Our project teams typically consist of a small core group that travels with a program from start to finish, and then brings resources in and out as defined by the program phase “In the early stages, for example, user insight, usability, industrial design and technical innovation are the heavy emphasis. Later in the process, engineers take over the heavy lifting. Finally, the rigours of the FDA requirements kick in and so quality assurance and compliance take over there.” Possibly human factors engineering doesn’t get the column inches it deserves. However its importance and increasingly significant role in the design and manufacture of medical devices cannot be underestimated. With FDA guidance in place now for several years, it will be interesting to see how this affects future device design – it should be very positive indeed.
WWW.MEDICALPLASTICSNEWS.COM
31
3D PRINTING
Surgical spirit A
fter several years of solely relying on surgical experience and extended theatre times, King’s College Hospital – one of the UK’s largest major trauma centres – turned to Stratasys PolyJet 3D printing technology. Using its Objet Eden250 3D Printer, the hospital 3D prints super-fine-detailed planning models for all of its maxillofacial procedures, enhancing its treatment delivery of complex facial disfigurement cases and helping surgeons preempt potential surgical complications.
King’s College Hospital improves patient care for complex craniomaxillofacial disfigurement procedures since integrating Stratasys 3D printing
Originally founded as a training facility in 1840, King’s College Hospital has established itself as one of London’s busiest teaching hospitals and is internationally renowned for its pioneering work in patient treatment, particularly within liver and foetal medicine. With over 170 years’ experience, the hospital is also recognised as a national specialist in dealing with trauma cases across a range of departments, including maxillofacial care. Maxillofacial care by its very nature demands a highlevel of surgical experience to successfully complete the procedure. King’s College Hospital is a major regional centre for facial and jaw surgery, which Dr Hatamleh and his colleagues play a crucial role in supporting. The
Printed word: Dr Muhanad Hatamleh, senior maxillofacial prosthetist at King’s College Hospital, with the trauma unit’s Stratasys 3D printer
Model answer: Using Stratasys 3D printed models during presurgery planning, surgeons can perfect treatment on the patient model prior to the operation – improving patient care
hospital has eight surgeons that carry out over 1200 planned craniofacial (skull) and maxillofacial (face and jaw) procedures every year. This figure doesn’t include trauma surgery carried out to faces and jaws in the immediate aftermath of injury occurring.
Using 3D printed models for presurgery planning After several years of extended theatre times and limited surgical planning materials, the maxillofacial department turned to Stratasys PolyJet 3D printing technology to produce highly-accurate, customised surgical planning models. Using its Objet Eden250 3D Printer, the hospital converts 2D CT scans of the patient into replica 3D printed models for its maxillofacial, neurosurgery and orthopaedic departments. With the anatomical models, the surgeons can perform complex procedures prior to the operation and highlight any problematic areas before making any incision on the patient. “With 3D printing, surgeons already have an idea of what the procedure entails before the patient is under anaesthetic,” said Dr Hatamleh. “In the case of skull meningioma, where there is a tumour growing in the skull, the surgeon needs to remove the tumour and restore the skull at the same surgery. Producing a 3D model of the skull with the tumour enables our surgeons to clearly visualise the outcome of the surgery before it is performed and make better decisions on the size of the implant required to restore the skull defect after removing the tumour. “Since incorporating 3D printing into our planning, even the most complex cases do not surpass long operating hours. This means that, the hospital is able to potentially make some significant savings using this technology,” he added. According to Dr Hatamleh, King’s College Hospital now produces 3D printed planning models for 100% of its maxillofacial surgery and neurosurgery and beyond reductions in operating times and costs, 3D printing is also playing a crucial role in directly improving patient care. “Using this technology, we can produce around several different models simultaneously in super-fine 16 micron layers. This resolution is crucial in retaining specific details of individual patients’ anatomy,” explained Dr Hatamleh. “For us, having a 3D printed model for restoring skull defects-cranioplasties is a must. It enables us to correctly fill the defect to normal contours, which is then reproduced in hard stone that is used in swaging a titanium plate in place. The plate is then is implanted, to not only restore the missing skull contours, but also protect the brain parenchyma. Overall, this improves patients’ confidence and quality of life”.
32
WWW.MEDICALPLASTICSNEWS.COM
3D PRINTING
Time travel Amith Belawadi, The Tech Group, examines how 3D printing is being used in medical device contract manufacture and the benefits that improve lead times from concept to development and validation
34
WWW.MEDICALPLASTICSNEWS.COM
3D PRINTING
B
ringing new products rapidly from development and into full-scale production in today’s environment has never been more demanding. Market pressures on new and potential customers require the development, scale-up, and transfer to full-scale manufacturing Print works: Fixture on the be done faster, better, cheaper. The Tech Group, left is the design that was West’s global contract manufacturing solutions tested by printing. Through provider, leverages multiple types of technology an iterative process the to aid in all project phases. design was finalised and the metal fixture shown on the right was created
One such leveraged technology is the in-house 3D printing capability, also referred to as desktop fabrication or additive manufacturing. Over the course of the past 20 years, 3D printing has gone from being cumbersome and complicated to a valuable, real-life product design and manufacturing solution. One of the most significant applications of 3D printing is in the medical industry. Today this technology is helping medical device companies in a variety of industries realise their design ideas at every stage – from concept to commercialisation and saving time and money in the process.
Making ideas tangible in the conceptual design stage For contract manufacturers working with medical device companies, the primary means of communicating early design concepts is typically by CAD files and 2D drawings. This sometimes leads to design misinterpretation due to the virtual nature of the data. By using 3D rapid prototyping methodology, designers are able to create physical models of multiple of design iterations allowing them to ‘test’ which design will work best. Through trial and error, designers discover which device features and functions are most effective, manufacturable and user-friendly.
Preparing functional prototypes Having the actual, tangible component or components is proving itself to be invaluable when engaging with our customers. Traditionally, manufacturers were using 3D printing early in the design process stage to generate inexpensive, yet accurate prototypes allowing manufactures and engineers to check form, fit function without committing a significant amount of capital. It also allowed them the flexibility to gauge customer response and compare design iterations within days. What used to take weeks or months, could now be accomplished in days or hours. As a Proof of Principle however, the capability does not end in the development phase. 3D printing has also proved beneficial in mould design, metrology fixture design and end-of arm tooling reviews.
Aiding in mould design Once a part design is agreed upon, there is the opportunity to use 3D printing in creating a mould for the selected design. A 3D printed mould provides prototype parts moulded from production intent material in a matter of days rather than weeks. By moulding parts from the same material we are able to match performance characteristics of the part as designed. This step also helps in gaining valuable knowledge in mould design early on which can then be implemented when production moulds are made. It also provides a great opportunity in trying advanced cooling methods like conformal cooling and custom cooling channel geometry which might not be possible in traditional mould-making methods.
printed moulds are the closest match to actual production parts; providing strength, look and feel and performance using the same resin intended during production. This is the fastest method yet, to provide true ‘working’ prototype samples.
Creating fixtures for validation and metrology Typically, design and manufacturing of an inspection fixture for CMM or Vision system could take upwards of four to six weeks and depending on complexity could be costly. With the advancements in precision and repeatability, 3D printing can be used to improving the total lead-time to < one week. The process of fixture design has not changed. The major design consideration is to hold and orient the part for inspection measurements. Medical devices are in nature, complex in design and shape. Traditional machining methods are cumbersome, time consuming and costly. 3D printing allows designers to easily replicate the shapes and nuances that are needed for the part to be properly nested in the fixture. Printing a metrology fixture, EOAT (end of arm tool) grippers or tooling mounts/ plates in short order allows development teams to test designs prior to manufacturing the final version. Whether it’s a fixture to hold one part or eight parts, the fixture can be scaled up as production volumes increase. Additionally, duplicate fixture can easily and quickly be produced for another department, customer, or even third party. Our customers have been intrigued by the price and advantages of 3D printed fixtures. Costs are on average, more than 50% cheaper than traditional hard-tooling fixtures. This allows both the medical device and contract manufacturers to utilise replicates of the same fixture in turn reducing errors due to differences in measurement related to fixture variability. 3D printing technology has enabled the Tech Group to reduce project timelines, for both internal and external customers. With a 3D printed fixture, as well as 3D printed parts, metrology can begin inspection routines, before the tool is completed. Metrology can complete a gauge R&R study, prior to mould acceptance. Completing these activities early, enables the development team readiness and response first off inspection of product produced during tooling FAT, process development and validation. This method of in-parallel manufacturing provides significantly shorter project timelines. Overall, The Tech Group uses advanced in-house technology to reduce overall cost and time for our customers ensuring a reduced risk and speed-to-market solution. The Tech Group utilises 3D printing in the early stages of concept and design, to refine the design with 3D printed moulds and producing parts from the specified material. Through the development stage, using 3D printed fixtures for inspections and measurements. By planning and executing these tasks in parallel with each other, overall timelines to validation are reduced. Fully utilising 3D printing in all areas results in REAL benefits for our customers.
Flash dance: 3D printed metrology fixture in use on an OGP machine
Although 3D printed parts provide a quick way to check form and fit it lacks the ability to replicate properties like strength and performance during cyclic assembly. Parts from 3D
WWW.MEDICALPLASTICSNEWS.COM
35
NEC BIRMINGHAM, UK | 26-28 SEPTEMBER 2017
INJECTION MOULDING
EXTRUSION
ROTATIONAL MOULDING
BLOW MOULDING
RECYCLING
THERMOFORMING
M AT E R I A L S
VACU UM FO R M I N G
DESIGN
FILM EXTRUSION
EXHIBIT NOW www.interplasuk.com
STERILISATION
CLEAN LIVING E
nXray, a UK medical technology start-up is commercialising its technology for sterilisation of medical devices and life science products with the aim of developing, producing and According to EnXray distributing equipment for in-house its sterilisation product sterilisation.
for the medical sector will improve efficiency as well as cutting costs allowing manufacturers to sterilise devices at the point of production
An early prototype was developed in conjunction with Tharsus Group, a collaborative manufacturing specialist. The technology will enable medical equipment manufacturers to sterilise medical devices at the point of production.
Medical devices must meet stringent regulatory requirements, including ISO13485. This governs the manufacture of medical devices, including the requirements for medical devices to be designated sterile. Sterility is typically defined by demonstrating a 6 Log reduction in the bacterial load to achieve the required Sterility Assurance Level (SAL). Currently, the majority of OEM medical device manufacturing sterilisation is performed on an outsourced, third-party basis, with approximately 53% of the market treated with ethylene oxide (ETO) gas sterilisation, and 43% using some form of ionising radiation (gamma, electron beam or high energy x-ray), and the remainder comprised of other methods, such as autoclaving, H2O2 gas, O3 and NO2 gas. This can vary considerably in different regions. For example, the UK market is heavily reliant on ionising radiation. China predominantly uses ETO; however, a large number of gamma facilities are being built, which will increase radiation sterilisation in that region. While the US is broadly in line with the global breakdown, this can vary regionally within the US, based in part on proximity to the third party service providers’ regional capabilities. Ionising radiation and ETO sterilisation are capital intensive systems and when transportation and logistics time is considered, sterilisation represents the largest single process step involved in getting the product manufactured and delivered to the point of care. Edward Cappabianca, co-founder of EnXray, said: “Companies continuously seek process improvements and cost reductions, as well as competitive advantages in time to market. The last step of sterilisation is the only one outside of their control. Most manufacturers would prefer to manage sterilisation in house; however, the capital costs associated with current methods make it prohibitive, as well as additional health and safety requirements which would come with the existing methods.” To overcome this challenge, EnXray is pioneering a new approach to sterilising medical devices using low energy x-ray (LEXR). Cappabianca added: “With increasing regulatory pressures, combined with the need to identify costsavings, terminal sterilisation is an area that will become more important in the future. “With the advent of LEXR sterilisation, companies will be able to streamline their production processes, while lowering costs and improving time to market.”
The characteristics of LEXR make it suitable for individual ‘on site and on demand’ sterilisation of medical devices for OEMs. LEXR is not able to transmit very far however, the local absorption rate is very high, resulting in a high dose efficiency ratio. The intention is to provide a ‘matched kGy dosage’ to that achieved by the existing method, to provide an alternative for sterilising rush orders or small batches more efficiently. The modular nature of the equipment is expected to enable easy integration into most manufacturing environments, allowing for ‘distributed sterilisation’ that will increase efficiency and shorten time to market for many companies.
Clear winner: EnXray and the Tharsus Group have developed a prototype allowing medical equipment manufacturers to sterilise devices as they are made
This technology has now been developed into a prototype device by the Tharsus Group, which was part of a development partnership agreement with EnXray. Tharsus Group’s position as an early adopter of the original equipment design and manufacture (OEDM) outsourcing service model includes product design and development and contract manufacture. This will enable it to take the product from initial concept through to scaled production in the shortest possible time. Brian Palmer, chief executive of Tharsus Group, said: “This is a ground-breaking innovation that will have a significant impact on the way medical equipment is manufactured. “Tharsus will tackle the complexities that come with the realisation of EnXray’s latest innovation, mitigating risk and generating a commercially successful product based on the company’s intellectual property. “Our knowledge-based approach to new product creation enables our engineers to realise EnXray’s insight into its market, which will deliver a scalable system that will be manufactured for the global medical industry.” Cappabianca added: “Partnering with Tharsus is a significant element of the evolution of our expertise in medical sterilisation. Their specialism in the commercialisation of high value, electro-mechanical products will help us bring a new solution in the med-tech field that will meet the requirements of medical device OEMs.”
WWW.MEDICALPLASTICSNEWS.COM
37
ELASTOMERICS
Stretching the boundaries W
ithin the medical industry, demand is rising for safe and halogen-free polymers used in manufacturing medical products. Many polymer companies are filling the need with new materials like thermoplastic elastomers (TPEs). Hoan Tran, Kuraray For several decades, the medical America, explains how industry has relied upon styrenic block copolymers (SBCs), a type of safety and performance TPE, for use in a range of medical lead the way for use of products. TPEs process easily, have thermoplastic elastomers in excellent mechanical properties the medical industry and elasticity, and possess strong haptics. Their inherent low toxicity and compliance to medical and food contact regulations make TPEs a safe choice for specifying materials for use.
The below graph shows the range of properties possible when blending Hybrar with various ratios of PP.
Soft elastic modification of polyeolefin tubes
With more than 30 different types of TPEs with individual product properties, Kuraray offers a diverse portfolio for the medical market. These TPEs are safe and non-toxic, providing flexibility and performance in the design of medical products where superior performance and safety are needed most. Kuraray’s TPE products, Septon and Hybrar combine the elastic properties of rubber with the benefits of thermoplastics. Due to this thermoplastic nature, they can be processed into almost any shape. These TPEs have a soft touch and provide comfort and durability. Distinguished by their high clarity, non-allergenic characteristics and easy process-ability, Septon and Hybrar are perfect for applications such as medical tubes and pouches, orthopaedic gels, elastic non-wovens and films, patch adhesives and medical bags.
Medical tubes As environmental standards increase, medical tubes are now being replaced with polymers such as Hybrar as a cost-effective solution for soft-touch applications. Due to its toughness, transparency, flexibility and physical properties, Hybrar meets many of the new characteristics needed for medical tubing. This TPE has excellent miscibility with polypropylene (PP) and has high affinity to polyolefins and styrenics, making it extremely transparent and easy to process. Hybrar blends with PP are soft, transparent, offer good kink resistance, have high-temperature performance and are solvent bondable. In comparison to PVC, Kuraray Hybrar has similar physical properties but lower density. Being halogen and phthalate-free, Hybrar meets many of the environmental and safety standards that PVC cannot meet. Moreover, compounds made out of Hybrar and PP have high tensile and excellent impact strength. The polymer structure of Hybrar also ensures relatively good oxygen and moisture permeability compared to other elastomers.
38
Orthopaedic gels Kuraray’s Septon is a series of high-performance, thermoplastic rubbers that are based on the company’s SEEPS technology. Styrene Ethylene Ethylene-Propylene Styrene (SEEPS) grades are comprised of copolymers with both isoprene and butadiene in the midblock. Two specific versions of Septon – Septon 4000 series and Septon J series – can be used to create orthopaedic gels. The Septon J series and Septon 4000 series provide orthopaedic gels with stability and super soft characteristics giving the products a natural skin-like feel and performance over a broad temperature range. With their low specific gravity and high tear strength characteristics, these products can replace silicone in various applications. Additionally, characteristics like lower melt viscosity, excellent low temperature behavior and superior process-ability at a low shear rate ensure enhanced overall process-ability and production efficiency. Developed for high-performance products where long lasting stability and compression set are key requirements, Septon J series and Septon 4000 series can be used in applications such as cushions for artificial limbs, orthopaedic bandages, prostheses and burn plasters. Their excellent shock absorbing and damping properties combined with non-allergenic qualities meet the high demands in this industry.
WWW.MEDICALPLASTICSNEWS.COM
ELASTOMERICS
The below graph shows the comparison of tear strength and density of Septon to silicone and urethane gels.
Patch adhesives Various products within Kuraray’s Septon line can be processed for patch adhesives. The Septon 4000 series can be used when there is a need for products with extremely high cleanliness. Their well-balanced adhesion and cohesion force makes patch adhesives with Septon products easy to peel off. For the consumer, this reduces the risk of allergies.
Medical bags Kuraray’s Septon and Hybrar lines are suitable for dry blending in film extrusion processes most often found in the manufacturing of medical bags. Both TPEs show maximum softness and elasticity. Due to their compatibility with polyolefins, they allow great flexibility to create film properties that normally cannot be achieved with commodity polyolefin resins alone. They perform well in high temperatures, can be sterilised and down-gauged due to their improved impact resistance. Furthermore, there is no migration of PVC plasticiser compared with PVC bags.
Gravity tear strength
Elastic non-wovens and films As elastic non-wovens and films continue to grow their presence in the market, so has the need to maintain optimal cost performance balance. Kuraray’s Septon 4000 series is designed for high-performing elasticity making it an excellent solution for many elastic nonwovens and films. For consumers, the main advantage is higher comfort and a decrease in creep resistance. These distinct properties lead to down-gauging probabilities. Also, significant material savings – as much as 40% lower material usage and 40% weight reduction over competitive products – can be achieved while maintaining mechanical properties, compared with other thermoplastic elastomers. Kuraray’s Septon 4000 series combines the strength of SEBS (styrene ethylene butylene styrene) elastomers with the softness expected of SBS (styrene butadiene styrene) and SIS (styrene isoprene styrene) elastomers.
In the field of flexible packaging films made from polyethylene and PP, Hybrar offers various grades that can be added for specific customisation. Compared with plastomers or polyolefin elastomers, these materials perform in the lowest concentrations necessary to achieve maximum value. The main advantage is impact resistance for down-gauging purposes. Specifically for PP, Hybrar can reduce the sealing initial temperature (SIT) up to 10 degrees.
Layer graphic
Stress strain creep loss
Medical applications today are becoming more demanding from both a performance and safety standpoint. This requires materials that go beyond standard SBCs that satisfy value-added solutions in a variety of processing technologies and end-use conditions. SBCs continued advancement in extrusion and injection-moulding process development further drive adoption into new application areas. Due to the concerns with PVC, SBCs offer a safer and more environmentally-friendly alternative with comparable performance. As the market continues to evolve, so will technology with new materials.
WWW.MEDICALPLASTICSNEWS.COM
39
CAD/CAE SOFTWARE 3D PRINTING ADDITIVE MANUFACTURING MOULDING & TOOLING MACHINE TOOLS METROLOGY INSPECTION
28 SEPT - 29 SEPT 2016
REGISTER NOW
LASER WELDING
THE CIRCLE LINE “I
n the past, LPKF had compelling solutions in the form of outstanding individual systems for laser plastic welding. We have now begun the production of customisable basic machines – which not only benefits us but also our clients,” explained Markus König, one of the managing directors of the LPKF production site in Fürth, Germany.
New production processes using cylic assembly at LPKF have had a positive effect on the company’s clients and efficiency
The most important step was moving out of the restricted rooms in Erlagen into the spacious production buildings in Fürth, as well as the construction of a new office block. This contains the application centre which is equipped with several testing rooms, laser systems and measuring devices for welding tests and to qualify the own processes of
clients. At the site the production services company LaserMicronics uses its own LPKF laser systems for ramp-up and series production.
Radical restructuring of the production flows took place at the beginning of April. Instead of the design and production of individual special machines, the work now concentrates on cyclic assembly of high-performance basic machines. These models are then used to realise customised modifications in subsequent fast and cost-efficient processes. Cyclic assembly opens up greater flexibility for complex technical developments which benefit whole production lines rather than individual systems. The first throughput of a complete line has now been completed, and confirmed the expected advantages. “Our customers are very keen on this concept. We have been able to slash the construction time by almost half and therefore also significantly reduce the lead times and manufacturing costs. We can also prepare quotes much faster than before, and it makes it easier for provide services – which naturally benefits our customers in particular,” said Lars Ederleh, managing director.
Instead of the design and production of individual special machines, the work now concentrates on cyclic assembly of high-performance basic machines.
WWW.MEDICALPLASTICSNEWS.COM
41
Whatâ&#x20AC;&#x2122;s the cure for your bonding application?
Hackensack, NJ 07601, USA â&#x2C6;&#x2122; +1.201.343.8983 â&#x2C6;&#x2122; main@masterbond.com www.masterbond.com
PLASMA TREATMENT The widest range of plasma processes & plasma surface modification equipment from the 6, T MFBEJOH NBOVGBDUVSFS
t 4VSGBDF BDUJWBUJPO UP JNQSPWF BEIFTJPO t 4VSGBDF GVODUJPOBMJTBUJPO t 1FSNBOFOU IZESPQIJMJD IZESPQIPCJD DPBUJOHT
Summer promotio FREE upg n rade fo
Low cost Simple to use High reliability
7*4*5 063 46..&3 130.05*0/ 1"(& '03 DETAILS
42
5&- +44 (0)1925 830 771 info@plasmatreatment.co.uk &."*- info@plasmatreatment.co.uk www.plasmatreatment.co.uk WEB: www.plasmatreatment.co.uk
WWW.MEDICALPLASTICSNEWS.COM
r details p lease visit our website using the q r c o de link or em ail us usin g the code TVNNFS
ROBOTICS
Rise of the
machines
Recent research has predicted that one in three jobs will be automated using robotics or software by 2025. Graham Mackrell, Harmonic Drive UK, looks at the future of robotics and the role they will continue to play
T
he robotics revolution is upon us. It has long been the topic of sci-fi thrillers but now it has arrived it looks very different to the way we envisioned it. Mechanical men don’t march among us, in fact robots are mainly used in industry and they have only just been permitted to operate outside a robot cell. Research published by analyst firm Gartner has predicted that one in three jobs will be automated using robotics or software by 2025. A recent report from International Data Corporation reinforces these findings, claiming that the robot market is set to boom in the next three years, growing at a Compound Annual Growth Rate (CAGR) of 17%. For decades robots have performed a multitude of pick and place functions in many industries that would have previously been filled less efficiently by human workers. Despite market growth and continued adoption, these robots have not rendered human workers obsolete. In fact, the two co-exist through collaborative robotics – the latest trend in industry. For example, surgical robots rather than replacing surgeons, enable them to perform complex procedures with high accuracy. The result is a safer operation and surgeons who are able to work further into old age thanks to increased the steadiness and precision provided by robotics. Before robots can be implemented in other sectors of industry and trade, health safety standards need to be put in place. The British
Automation and Robot Association (BARA) states that the only way to ensure safety in robotic workplaces is to “exclude people from the robot working area”. Not only would this prove difficult in many non-factory settings, it is also counterproductive for developments in robotics. Rather than separating humans and robots to prevent the risk of harm, we should be looking to construct robots that are safe to use alongside workers. Fortunately, the robotics industry has been working towards realising the vision of collaborative robots for some time now. In 2013, the first safety standards for collaborative robotics, ANSI/RIA R15.06, were published, signalling a period of change for industry. More recently, the ISO/TS 15066 standard was published in March 2016. It specifically outlines guidance and requirements of collaborative industrial robot systems. This was dubbed a “game changer for the industry” by Carole Franklin, secretary of ISO/TC 299/WG 3, as up until its release “robot system suppliers and integrators only had general information about requirements for collaborative systems. [ISO/ TS 15066] gives specific, data-driven safety guidance needed to evaluate and control risks.” As more industries begin to adopt collaborative robotics, we will undoubtedly see the release of even more standards to govern them in new sectors. Robot manufacturers will be under constant pressure to maintain high levels of reliability and repeatability, both in the
WWW.MEDICALPLASTICSNEWS.COM
software used for programming robots and the components they are made with. Reliability, repeatability and payload form a holy trinity of robotics requirements. Because collaborative applications require robots to operate at high speeds and in the company of workers, it is crucial that the internal components provide consistent performance. In particular, precision gears that allow robots to move to exact measurements and stop without delay and zero backlash are particularly important for the future of robotics. If a surgical robot is unable to operate with absolute precision, it can put patients at risk during the surgery. Safety can be guaranteed by using robotic gears, such as our HFUC2UH series, that offer repeatable peak torques and are lightweight and compact, enabling the robot to be both nimble and reliable. Likewise, robots in handling applications rely heavily on spatial awareness and movement. Cameras are often used to simulate vision but these must offer a high quality image to be effective and prevent both harm to workers and inventory pile-up. In regards to safety, the robot must also have the capacity to react quickly to a human presence. A robotic future does not have to be a concerning concept as long as manufacturers do not cut corners on components. By ensuring a consistent performance, humans and machines can work side by side without worry.
43
CLEANROOMS
In the zone: There are four zones inside Tex Plastics’ cleanroom separated by partitions – two housing Arburg injection moulding machines, a packing area and a goods transfer area
CLEAN SWEEP T
he continuous improvement strategy towards cost-effective, lean production for medical plastics, comes with an explicit requirement for innovation Cleanrooms and scalability for today’s manufacturing facilities.
It also increases the risk of contamination and safety issues as the overhead crane inevitably retains particles and cleaning it is a cumbersome and difficult task – not to mention the hopper creating a mass of contamination within the cleanroom.
In looking to increase its manufacturing capability offering with cleanroom production, Tex Plastics’ technical & quality director, Andy Clarke and manufacturing director Dave Kearney, used the services of Connect 2 Cleanrooms.
According to Connect 2 Cleanrooms, a more cost-effective and energy efficient option is to create a modular cleanroom on castors, that can be wheeled away to provide aerial crane access. While this low-cost solution is a practical solution for many, it creates downtime as machinery requires a full clean down following exposure to the external manufacturing environment.
Connect 2 describes how it can deliver customer-driven cleanroom innovation for medical plastics manufacturing
Tex Plastics says its mission to develop higher performing, lower cost solutions for its clients, has been boosted by a class 7/8 cleanroom system that includes automated clean-air HEPA-lite canopies.
The tooling challenge When considering injection moulding processes, the tool face of the machine is often the most exposed area of the production line and this is the area which often requires the supply of controlled air. A simple way to achieve this is to enclose the full machine in a cleanroom; however this brings inevitable challenges of managing tool changes. Enclosing the machine, mould and crane creates a large environment in floor space and height. This approach leads to a vast amount of air being unnecessarily processed, negatively impacting on attempts to reduce carbon emissions.
44
This increases the risk of contamination and reduces the ability to offer a timely response to customer schedule changes. Manufacturing and production staff have been working around or compromising on these issues for years, but Connect 2 Cleanrooms R&D team has developed a solution with an automated canopy system for its cleanrooms. Through an intuitive user-friendly touch screen interface, Tex Plastics is able to remotely activate actuators that slide sealed HEPA-lite canopies back in the ceiling of the cleanroom, to allow overhead crane access to tooling. This customer driven requirement ensures that clean air is supplied at the critical point of production and reduces contamination by significantly limiting the areas of machinery that are exposed to the external environment
WWW.MEDICALPLASTICSNEWS.COM
CLEANROOMS
during tooling changes. This limits downtime for cleaning, reduces risk of contamination and increases productivity. The canopy is a bespoke unit, containing a MAC10XL HEPA filter – fully sealed to facilitate the re-circulation of the cleanroom’s air conditioning. ULPA filtration is also able to be inbuilt for those users looking for higher cleanroom classifications. An LED warning beacon above the control panel visually indicates when the canopy is open, reminding operators to close the canopy, prior to new batch production. This innovative and market leading cleanroom solution, features LED strip lighting around the underside of the canopy for extra lux levels, illuminating the tool face for operators.
From a distance: Tex Plastics can remotely activate actuators that slide sealed HEPA-lite canopies back in the ceiling of the cleanroom, to allow overhead crane access to tooling
Effective cleanroom design There are four zones inside Tex Plastics’ cleanroom separated by partitions – two housing Arburg injection moulding machines, a packing area and a goods transfer area. If one machine needs decommissioning or servicing, this can be achieved safely without affecting any of the other processes.
Auditable control
The modular design means that additional space can be added to accommodate more machinery or create a larger packing area. This gives clients the peace of mind that scalability and future capacity is achievable when required.
The touch screen interface also acts as a control system, allowing full control of HEPA filtration and lighting levels, as well as monitoring pressure levels and alerting staff if the cleanroom is operating out of specification.
Tex Plastics supplied 3D models of its machines allowing Connect 2 Cleanrooms to maximise on floor space when designing its cleanroom and ensure a seamless installation programme with minimal disruption to Tex Plastic’s production team.
All of the pressure data is logged, exportable and auditable, to demonstrate performance and continued compliance of the production processes.
The cleanroom is now fully operational, completing the ‘concept to completion’ project solution for all conventional, white room and cleanroom thermoplastic requirements.
WWW.MEDICALPLASTICSNEWS.COM
45
The film: Eternal Su The year: nshine of th e Spotless 2004 The budget Mind : $20 million Box office takings: $7 2. 3 million Rating: 8.3/10 IMDB Leading ligh / 93% Rotten ts: Tomatoes Jim Carrey Kirsten Du , Kate Winsl nst, Mark Ru et, ffalo, Elij Written by ah : Wood, Tom charlie kauf Wilkinson directed by man : michel gond ry
MEDTECH at the movies
Quirky cult fantasy in which medical devices meet magical realism
ETERNAL SUNSHINE OF THE SPOTLESS MIND
The public perception of our industry is in part shaped by Hollywood’s depictions of the devices, companies and individuals that keep the machine moving. This issue, David Gray reflects on Eternal Sunshine of the Spotless Mind
46
And this is where the science fiction becomes science fact. DARPA says it will support the development of multiscale computational models with high spatial and temporal resolution that describe how neurons code declarative memories — well-defined parcels of knowledge that can be consciously recalled and described in words, such as events, times, and places. This language may resonate with viewers of films like Eternal Sunshine or Memento.
Synopsis
Two lovers separate in the ultimate fashion – by having their memories of one another erased via medical device. But will love endure?
Devices
The premise of the film is based on protagonist Joel’s experience with fictional medtech company Lacuna, Inc. After learning that his estranged girlfriend Clementine has paid this firm to have her memories ‘erased’ via a new experimental procedure, Joel, unable to cope with the heartbreak, undergoes the same procedure. In typical Michel Gondry style, the process of analysing Joel’s memory becomes a weird and abstract journey that dominates the movie. The idea is that Lacuna’s device, an outrageous headset resembling something from a 70s hair salon, systematically causes a mild form of brain damage which targets only specific memories.
Basis in reality
A device that causes brain damage to erase unwanted memories? Let’s face it, the closest science has come to that is the lobotomy – now a much discredited, and highly damaging – method of ‘treating’ psychiatric conditions. But the idea of a device that restores memory function might not be so far-fetched. Traumatic brain injury is a major cause of memory problems, especially prevalent within military veterans injured in battle. US agency DARPA (Defense Advanced Research Projects
Jim Carrey looks to Medtech to reset his love life in this cult indie fantasy. Copyright: Featureflash Photo Agency
Agency) has initiated a program called Restoring Active Memory (RAM). DARPA says it seeks to “accelerate the development of technology able to address this public health challenge and help service members and others overcome memory deficits by developing new neuroprosthetics to bridge gaps in the injured brain”. This, DARPA says, would involve developing a wireless, fully implantable neural-interface medical device for human clinical use.
WWW.MEDICALPLASTICSNEWS.COM
The researchers will also explore new methods for analysis and decoding of neural signals to understand how targeted stimulation might be applied to help the brain re-establish an ability to encode new memories following brain injury. “Encoding” refers to the process by which newly learned information is attended to and processed by the brain when first encountered.
Why you should see this film
From the industry’s perspective, this film provides a fun alternate reality to the real world of medtech. Lacuna as an organisation is operated under the radar, in a small site designed to look like a plastic surgeon’s office – this is due to the controversial nature of the research. Its treatment of our industry is light-hearted and uncynical. And besides, it’s a cult classic.
Think you’re a master of rubber seals?
Show us what you’ve got. Whether you’re an aspiring engineer or the head executive of a manufacturing organization, the Apple Rubber Academy certification is a chance for you to prove your expertise on rubber materials, sealing best practices and engineering quality.
Take the five-chapter course and become the in-house expert today! applerubber.com/academy