MPN EU Issue 30 by MPN Magazine

MEDICAL PLASTICS news

IN W A L E

C N I S S

Industry exhibitions in focus: Med-Tech Innovation Medtec Europe

IT’S ALL IN THE DETAIL

Phillips-Medisize’s combo products expertise ISSUE 29

March - April 2016

WWW.MEDICALPLASTICSNEWS.COM

Come visit us at Chinaplas

Come visit us at Chinaplas April 25â&#x20AC;&#x201C;28 / Booth E3F01

April 25â&#x20AC;&#x201C;28 / Booth E3F01 chinaplas.husky.co/Chinaplas2016

CONTENTS March - April 2016, Issue 29

Regulars 5 Comment 7 News analysis What’s the thrust of the FDA’s draft guidance on interoperability?

Features

8 Digital spy 12 News profile Chinaplas’ medical focus

25 Spotlight on Innovation Some of the sector’s brightest lights in focus

14 News profile What Medtec Stuttgart has to offer

28 Power Rangers Accutronics looks at increasing the longevity of medical device batteries

17 News analysis What you need to know about unique device identification

31 4 things to think about... ...when choosing a high performance

20 Cover Story Phillips-Medisize talks device development for combo products

33 Water world Polymer Solutions, looks at understanding necessary analytical techniques of hydrogels

23 Q&A Stephanie Berman, Berman Innovations 46 Beady Eye Stéphane Regnault, Vygon looks at the single use medical devices sector

43 Automatic for the people Sumitomo (SHI) Demag explains how automation can lead to faster return on investment, among other things 46 Part of the process Trinseo reveals how a process approach to moulding can lead to better results 49 Dressed for success How elastomer is protecting against hospital-acquired infections

37 Centre Point What this year’s MTI Expo has to offer 41 A word with the boss Jeff Barrett, J-Pac Medical outlines his plans for the business

WWW.MEDICALPLASTICSNEWS.COM

W O R K W I T H

T H E

CATHETER

EXPERTS

Extensive, vertically-integrated capabilities. Deep expertise in diagnostic and interventional catheters, which includes balloon catheters, steerable catheters, and micro-catheters.

Visit us at MEDTEC Europe, stand 5821

Decades of experience. We are the experts when it comes to custom-engineered catheters. Our team has what it takes to inspire innovation, follow through on every detail, and, ultimately, get your product into the market.

Let’s get to work on your project.

extrusions

Limerick, Ireland | Phone: +353.61.331906 Email: oeminfo@teleflex.com Web: www.teleflexmedicaloem.com Connect with us on Facebook, LinkedIn, and Google+.

catheters

balloons

medical devices

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

EDITOR’S

comment

editorial assisstant | emily hughes advertising | mandy o’brien art | sam hamlyn publisher | duncan wood

Medical Plastics News is available on free subscription to readers qualifying under the publisher’s terms of control. Those outside the criteria may subscribe at the following annual rates: UK: £80 Europe and rest of the world: £115 subscription enquiries to subscriptions@rapidnews.com

Medical Plastics News is published by: Rapid Life Sciences Ltd, Carlton House, Sandpiper Way, Chester Business Park, Chester, CH4 9QE

SUSPEND BELIEF At the end of last year US medical device companies received an early Christmas bonus with the news that the medical device tax had been suspended for two years. The 2.3% excise tax was met with glee from lobbying groups including AdvaMed, the trade US trade association, which had been pushing for the freeze for some time believing the tax had a negative effect on the sector. As the news of the suspension was announced, Nelson Mendes, president and CEO of Ziehm Imaging commented: “We are grateful that congress was able to come together to preserve US jobs and medical innovation by delaying the device tax for two years.”

T: +44(0)1244 680222 F: +44(0)1244 671074

So it’s good news for the US medical device sector. But has the suspension started to make any difference at all to the industry?

© 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.

Initial reports would suggest yes. According to a report in The Post Star, Precision Extrusion, manufacturer of plastic tubing for the medical device sector, will be increasing its workforce by two or three thanks to the lifting of the tax.

BPA Worldwide Membership

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

On a bigger scale the tax suspension has been reported to be behind the collaboration between Boston Scientific and the Mayo Clinic which will see the sharing of intellectual property as well as the fast tracking of medical device development to address unmet medical needs. Speaking of the union between the two companies, Michael Mahoney, president and CEO Boston Scientific, said: “Our continued investment in this collaboration is an example of our commitment to further investing in jobs and innovation as a result of the recent suspension of the Medical Device Tax.”

Devices under development include a catheter for aortic-valve stenosis and the testing of the Precision Spectra Spinal Cord Simulator System which helps to block spinal cord signals that trigger shortness of breath and muscle fatigue during exercise. The device is aimed at heart failure patients and could take the place of drugs allowing these patients to exercise without their blood pressure hitting dangerous levels. A few months in and the benefits of the tax suspension seem to be having a positive effect. The tax had had a negative effect on companies such as Cook Medical which announced a suspension of its own three years ago when the tax first came into force – the business was planning the creation of five manufacturing plants at the time but this on hold. It was a similar story at Minnesota-based Smiths Medical which is now looking at a new way forward for the business. Press reports say the company was bringing in in over $1 billion a year for its medical products and was paying $10 million a year via the medical device tax. Speaking to NPR Health News, chief financial officer, George Montague said: “When this tax went into place it forced us to make cuts and sustain those cuts… and so now we’re getting that funding back…We’re making significant investment in our product portfolio — in improving our product portfolio.” With the suspension still in its infancy it seems many medical device companies are taking advantage of the opportunity to boost sales and bring products to market. An interesting time lies ahead as we see just how far innovation and device development will be taken along with manufacturing expansion and increased employment.

WWW.MEDICALPLASTICSNEWS.COM

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

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

NEWS ANALYSIS

FDA draft recommendations cover interoperability in medical devices THE FDA HAS UNVEILED DRAFT GUIDANCE FOR SECURE DATA EXCHANGE IN MEDICAL DEVICES

he FDA has published draft guidance aimed at improving the design of medical devices for safe data exchange.

The document outlines key points regarding the design and development of devices to ensure secure interoperability. According to the FDA “the increased use of interoperable medical devices has the potential to foster rapid innovation at lower cost”. However, it notes that inadequate interoperability can lead to errors, harm and in some cases be fatal. It states: “Manufacturers’ risk analysis should consider the risks associated with interoperability, reasonably foreseeable misuse, and reasonably foreseeable combinations of events that can result in a hazardous situation. Based upon these risks, a manufacturer may want to change the design of the device, the intended interoperability scenarios, or include device limitations and/or warnings to reduce risks to acceptable levels.” Regarding design for interoperable devices, the FDA says key considerations for manufacturers should be information model (data attributes), the functional model (role played within the interoperable system) and the architectural model (how the device is connected within the system. The “desired functional, performance, and interface characteristics of the electronic data interface” should also be taken into account. The guidance also comes amid a time of growing concern regarding cyber security attacks. This point was highlighted by Modern Healthcare which noted that the guidance “makes a nod to the numerous cyber security attacks on the healthcare industry in 2015 and predictions that 2016 could be even worse”. Labelling is also a key point in the guidance – it should include information on the electronic data interface so that the device can be used safely and effectively as it should. Correct labelling “should also enable users to connect to the device in the specified manner, and should give proper instruction to use the connection to the device in the ways in which it was designed”.

WWW.MEDICALPLASTICSNEWS.COM

DIGITAL

spy APPY TALKING

JACOBO CABALIERO, CAMBRIDGE DESIGN PARTNERSHIP SELECTS HIS FAVOURITE APPS

DEVICE UPDATE

Wolfram Alpha Do you need to solve an equation, plot some graphs or work out some statistics? More than just a simple app for helping students with their maths homework, Alpha is a knowledge engine useful to engineers and even scientists. Telegram As Richelieu once said: “Give me six lines written by the world’s most honest man, and I will find enough in them to hang him”. If you really care about your privacy, Telegram is one of your best messaging solutions. Or if your clients’ security is vital for your business, you can make use of Telegram’s end-to-end encryption to secure the data you’re sharing with your colleagues through any network, even if compromised. Feedly After the demise of Google Reader, Feedly was one of the existing news aggregation solutions that digested the bounced flow of users. If you’re looking for help minimising the effort required to keep your knowledge updated from your preferred online sources, Feedly is still one of the most solid offers with a strong user base. AirDroid With this app you’ll blur the borders between your desktop and your mobile devices. Avoid having to reach for your phone when sending the next SMS; do it from your desktop. You can also type on your smartphone using your computer keyboard and mirror your phone screen on your PC. Jota Text Editor Something as basic as editing a text file can be difficult to achieve in a stock Android table or phone. Jota is one of the best (and free) text editors available for Android, capable of handling very big files in a comfortable way. Crucial for techies, especially if you plan on ASCII art (yes, it supports monospace fonts).

Handheld, pen-sized microscope could ID cancer cells in doctor’s offices

handheld miniature microscope being developed by University of Washington mechanical engineers could allow surgeons to ‘see’ at a cellular level in the operating room and determine where to stop cutting. Surgeons removing a malignant brain tumour don’t want to leave cancerous material behind. But they’re also trying to protect healthy brain matter and minimise neurological harm. Once they open up a patient’s skull, there’s no time to send tissue samples to a pathology to definitively distinguish between cancerous and normal brain cells. The new technology is being developed in collaboration with Memorial Sloan Kettering Cancer Center, Stanford University and the Barrow Neurological Institute.

“Being able to zoom and see at the cellular level during the surgery would really help them to accurately differentiate between tumour and normal tissues and improve patient outcomes,” said Liu. The handheld microscope, roughly the size of a pen, combines technologies in a novel way to deliver high-quality images at faster speeds than existing devices. Researchers expect to begin testing it as a cancer-screening tool in clinical settings next year.

MATERIALS UPDATE

TRITAN COLLABORATION MEANS STOCK SHAPES AVAILABLE TO DEVICE DESIGNERS

JuiceSSH SSH is one of the most famous secure channel protocols, mostly known for commonly providing remote shell access in the Unix world, amongst other things. Soon to be adopted by Microsoft in PowerShell, JuiceSSH is one of the best Android SSH clients. 8

“Surgeons don’t have a very good way of knowing when they’re done cutting out a tumour,” said Jonathan Liu, UW assistant professor of mechanical engineering. “They’re using their sense of sight, their sense of touch, pre-operative images of the brain — and oftentimes it’s pretty subjective.

WWW.MEDICALPLASTICSNEWS.COM

o get tangible, sizable pieces of Eastman Tritan copolyester to medical device designers, Eastman Chemical Company has collaborated with Ensinger to convert resins into semi-finished stock shapes. These shapes showcase clarity, toughness and design flexibility of the material and allow designers to match those attributes to end-products, helping them understand how these medical devices will function after development. The extruded shapes made from Tritan MX710 resin will be marketed using Ensinger’s Tecadur brand. By using stock shapes designers can better understand at the onset of development how a material can be moulded and used for a medical device, making the process more seamless and efficient. Designers can use stock shapes for prototypes and also for full-scale manufacturing.

DIGITAL SPY

DIGITAL NEWS

Surgical robotics market growth predicted

talking

POINT

ccording to a new report by Allied Market Research, titled, World Surgical Robotics Market - Opportunities and Forecasts, 2014 - 2020, the global sales of surgical robotic systems is projected to reach $6.billion (£4.53 billion) by 2020. The gynaecology segment accounted for 28% share of the surgical robotic systems market share in 2014, and is expected to maintain its dominance during the forecast period. The major factors boosting the market are an increase in adoption of advanced robotic surgery over conventional open surgery, a growing count of surgical procedures, and rising incidence rates of gynaecological, neurological and urological disorders. However, the high cost of surgical robotic systems and procedures is the major factor restraining the growth of the market.

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 The tweet:

“Vibrator delivers hard-hitting security message @TrendMicro # s e c u r i t y #medicaldevice #data”

What the story?

Our web team couldn’t resist a wry smile when writing this one, but the message is a serious one. Security software group Trend Micro sent spokesman Udo Schneider used the sex toy as a prop during a talk at a security conference in Germany.

By simply typing a few lines of code into a laptop, Schneider was able to activate the device in front of the audience. It’s not the first time that an audience has been shocked by a medical device hacking. Back in 2011, diabetes patient Jay Radcliffe demonstrated hacking his own Medtronic insulin pump.

WWW.MEDICALPLASTICSNEWS.COM

The gloves are off…

…says the FDA as it considers a ban on powdered medical gloves gloves. Why does the FDA want to ban powdered gloves? It’s all about reactions. While powdered medical gloves may be easier to get on and off, their health risks are too great, says the FDA. In its Medical Glove Powder Report, the FDA states: “Glove powder on medical gloves can enhance foreign body reactions, increase infections and act as a carrier of natural latex allergens”. The use of powder-free, reduced protein content latex gloves has therefore been recommended. The ban covers powdered gloves used by surgeons and for examinations. It doesn’t include nonpowdered gloves – eg those used by surgeons, radiographers of for examinations. What is the powder? Cornstarch. The substance was introduced as a replacement for other substances such as talc which was found to cause inflammation. How dangerous is the powder? As well as causing allergic and breathing reactions, powdered medical gloves can irritate and inflame patients’ wounds. Commenting in Stat, Dr Jeffrey Shuren, head of the FDA’s Center for Devices and Radiological Health, said: “This ban is about protecting patients and health care professionals from a danger they might not even be aware of…We take bans very seriously and only take this action when we feel it’s necessary to protect the public health.” What’s the solution? According to the FDA: “There are alternatives to dusting powder for lubricating natural rubber latex surfaces. The most common method is chlorination. Chlorine reacts with the natural rubber latex surface to reduce the natural tackiness, eliminating the need for adding dusting powder. The extra washing performed during the chlorination process provides an added benefit by also greatly reducing the level of soluble natural latex proteins. However, chlorination affects some of the mechanical and physical properties. Gloves made from alternative materials, not containing natural allergens, are available, but none possess the unique mix of properties offered by natural rubber latex.” FDA is accepting comments on this proposal until June 20, 2016.

NEWS ANALYSIS

Life-saving tracheal surgery uses 3D-printed plastic splints A

n adolescent girl has received novel, 3D-printed tracheal splints to treat a congenital breathing condition called tracheobronchomalasia. She joins three baby boys and a baby girl who previously underwent similar groundbreaking operations. All five University patients continue to thrive, as their collapsed airways now function normally of Michigan thanks to the surgical procedure.

customises a biocompatible material for additively manufacturing medical implants

It was pioneered by Dr Glenn Green, a paediatric otolaryngologist and his surgical team from CS Mott Children’s Hospital, Ann Arbor, who joined forces with Dr Scott Hollister, professor of biomedical engineering and lead researcher at the University of Michigan.

Dr Hollister said: “Even if a market is relatively small, it doesn’t diminish the human need to be treated. It is estimated that one in every 2,000 children worldwide is affected by this life-threatening condition. “When I started designing my own porous scaffolds for anatomic reconstruction, I realised that 3D-printing would be ideal for creating the complex geometries I had in mind. “It is now pretty automatic to generate an individualised splint design and print it; the whole process only takes about two days now instead of three to five”. Polycaprolactone (PCL) was found to be the perfect material for additively manufacturing a tracheal implant. First, it has a long resorption time, which is very important in airway applications as the implant needs to remain in place for at least two years before it is resorbed. Second, PCL is very ductile, so if it fails it will not produce any particles that might puncture tissue. Third, PCL can be readily processed for and fabricated on an additive manufacturing system. Dr Hollister continued: “I chose an EOS machine because we were looking for a system that was flexible and allowed us to change parameter settings such as laser power, speed, powder bed temperature and so on, which we needed to do to customise our builds. “Also, because biomaterials can be expensive and implants and scaffolds are typically not so big, we wanted a more limited build volume that didn’t use a lot of material.

“EOS even gave us access to software patches to enable us to change the range of parameters of the machine to best process the PCL material.” The university team uses patient data from MRI or CT scans to examine the defect to be repaired, then creates computer models of the anatomy. Engineers are able to use a CAD system to design splints with a highly compliant, porous structure of interconnected spaces that will slowly expand with the maturing airway. Finally, the splint is produced in the EOS system. After fabrication, researchers measure the splint dimensions and mechanically test them. Following the operation, the splint-supported trachea expands and functions immediately, so when patients are weaned off oxygen they are able to breathe normally. Kaiba Gionfriddo, the first baby to benefit from the procedure, is now nearly four years old. The boy’s own tissues have successfully taken over the job of the implant, which has been almost completely reabsorbed into his body. To treat patients with birth defects or following illnesses or accidents, Dr Hollister’s group is also developing craniofacial, spine, long bone, ear and nose scaffolds and implants and additively manufacturing them using a material with characteristics that promote reconstruction and regrowth. He concluded: “I see a time soon, probably within the next five years, when many hospitals and medical centres will print their own devices specifically for their own patients and not need to get them off the shelf. “If we can expand the number of biomaterials used in additive manufacturing, we can tackle a tremendous number of problems in all fields of reconstructive surgery and make enormous strides for the benefit of patients.” Dr Green can be seen explaining the project in a video on YouTube: https://www.youtube.com/watch?v=s9r2gYT0aX4

WWW.MEDICALPLASTICSNEWS.COM

ThE arT of producTion EfficiEncy

RTQFWEVKQP TGNKCDKNKV[ OGCPU RTQFWEVKQP GHÆ&#x201A;EKGPE[ That is an art. Especially in sensitive sectors such as medical technology or optics. What counts here is reliability, part precision, quality and cleanliness of the production environment. So why not place your trust in our experience? (QT C RGTURGEVKXG

www.arburg.co.uk

NEWS PROFILE

Bright lights, big city A

s the trends toward miniaturisation, portability, improved aesthetics, and e n v i ro n m e n t a l responsibility drives ongoing changes in medical devices, selecting the right materials has become critical. Owing to plastics’ comparatively light weight, low cost, ease of processing, flexibility and superior biocompatibility, medical plastics have become an integral component in a range of modern medical devices and supplies, covering disposable syringes, intravenous blood bags, heart valves, etc. To achieve optimal product usability, appearance, endurance and performance, plastics are one of the best options for medical device designers.

Medical equipment demands high quality materials. The improvement of technology in the upstream industry will directly affect the development of medical equipment industry.

Spotlight goes to the medical plastics

TPRI (Tianjin Plastics Research Institute) will talk about ‘Applications of PEEK in Medical Sector’. PEEK has been widely used in the medical field due to its characteristics such as excellent biocompatibility, elasticity modulus similar to human bones and X-ray fluoroscopy.

Chinaplas takes place on 25-28 April at Shanghai New International Expo Centre (SNIEC). Organisers say that this year the spotlight will be on the medical sector

As the sourcing platform for plastics and rubber technology, Chinaplas 2016 has been recognised as Asia’s number one plastics and rubber trade show. More than 3,200 exhibitors coming from 13 countries and regions will gather at the fairground, occupying an exhibition area of 240,000 sqm. This year, more than 700 exhibitors will present technologies which are applied in the medical sectors, covering medical plastics materials, die and mould, injection moulding and packaging technology, automated production equipment, cleanroom solutions and detection technology. The exhibits on display, such as 3D printing technology, precision injection moulding, micro injection moulding, new silicone technology used in wound care and skin adhesion, breathable films for artificial heart-lung machines, automated high-speed adhesive dispensing and coating systems, automatic vacuum-forming blister packaging machines, sterile barrier systems, etc will help supporting the rapid development of the medical industry.

A two-day conference will be held from April 25 to 26 will provide an opportunity to the suppliers of medical equipment and packaging to grasp the latest technology updates of the industry. World-renowned plastics suppliers, technical experts and leading manufacturers of medical equipment are invited to share their innovative solutions in the field from different perspectives, including plastic materials, moulding and clinical applications. RTP Company has been invited to discuss ‘Plastic Technology That Resists Chemical Attack from Hospital Disinfectants’, explaining how newly developed alloys withstand the impact of the vast majority of chemical disinfectants in the hospital, while at the same time maintain the functionality and dimensional integrity of medical equipment.

Key names such as Krauss-Maffei, Netstal, Arburg, Davis-Standard, Engel, Husky, Kiefel, Milacron, Piovan, Tederic, Yudo, Mehow, Clariant, Convestro, DuPont, Dow Corning, DSM, Eastman, Evonik, Lubrizol, HEXPOL, Momentive, RTP, Teknor Apex Asia, will showcase the medical plastics technology. Highlights include: RTP 2000 HC Series developed by RTP Company is a proprietary alloy technology designed to maintain strength, functionality, and integrity, even with repeated exposure to hospital cleaners used to disinfect medical devices. These thermoplastic

WWW.MEDICALPLASTICSNEWS.COM

compounds can help solve cracking issues in existing devices and open a new realm of possibilities of the design of hospital equipment and plastic housings that require frequent disinfection. TSRC has announced the development of low styrene SEBS polymers: a novel series of Taipol SEBS featuring low styrene content, including one with high vinyl content, for lower hardness and excellent processability with polyolefins. DP014 is suitable for applications such as elastic film and packaging, plastic modification and hot melt adhesives. The highlight at the Netstal stand will be the production of 90mm-petri dishes made from polystyrol on an ELION 800-270 at a cycle-time of only 3.2 seconds. Instead of a costly removal and mounting device with complicated folding mechanisms a simple collecting device for free-falling parts is used. In this device, lid and dish are automatically aligned and merged so that the fully assembled petri dishes can be packaged and processed by the operator. Husky is a complete solutions provider of injection moulding equipment for medical components, including systems and moulds. Schöttli, a Husky company, designs and manufactures moulds for the injection moulding of medical consumables, including injection systems, infusion and transfusion therapy. Davis-Standard will promote its dsX product line including cast film, blown film, medical tubing and packaging technology. The new dsX s-tretch line for cast film is the first in-line pre-stretch cast film line of its kind enabling processing. Advantages include a comprehensive, flexible and pre-configured design, and a smaller footprint at two metres wide to simplify installation start-up. This line is capable of processing ultra-thin films at speeds up to 1,000 metres per minute.

You’re going to want to see some ID. Permanently mark your parts with Apple LaserMark.

applerubber.com

Apple LaserMark adds model numbers, bar codes, logos and more onto O-Rings and seals. The process – where laser light is focused onto a material, producing damage-free, readable marks – makes it easy for ĐŽŵƉĂŶŝĞƐ ƚŽ ŝĚĞŶƟĨǇ ƉĂƌƚƐ ĂŶĚ ůĞƚƐ customers know they’re receiving ƚŚĞ ĂƵƚŚĞŶƟĐ͕ ŚŝŐŚͲƋƵĂůŝƚǇ ƉĂƌƚƐ ƚŚĞŝƌ ĂƉƉůŝĐĂƟŽŶƐ ĚĞŵĂŶĚ͘

NEWS ANALYSIS

MEDTEC EUROPE INNOvation at its best

ccording to its organisers, Medtec Europe – 12-14 April, Stuttgart, Germany – is the perfect venue for suppliers of medical devices. In 2016 the exhibition will provide a range of attractions, interactive shows and informative expositions. The event is designed to be the What’s on idea place to receive the latest products, offer at Medtec see new innovations and hear experts talk on a variety of subjects regarding Europe 2016 – medical engineering. Medical devices the exhibition manufacturers will be provided with news about current technologies and suppliers of innovation in plus tips on how to grow their business. medical device Medtec Europe will also feature an education programme including technology enhanced seminars, product demonstrations and panel discussions. This year Medtec is offering interactive events, for a new visitor experience. Innovation tours will showcase the very best innovations from over 500 medical device suppliers. Nine different tours are offered over the three days, each introducing a different sector.

Day1 Medical materials and components ■ Extrusion and tubing ■ Automation ■

Day 2 Medical materials and components ■ Medtec Europe start-up academy ■ Packaging, labelling and sterilisation ■

The Start-up Academy will be returning to this year’s event, providing start-up companies with the opportunity to Day 3 showcase innovative ideas, and offering the ■ Medical materials audience with an insight and components into the products of ■ Electronic the future. In addition components, control to meeting potential ■ Additive manufacturing business partners, start-up companies are judged by the Medtec Advisory Board, which is made up of leading industry experts. The winner will be presented with a trophy and a €2,000 award, receive extensive PR coverage and become enrolled into a mentoring program with advice from leading experts in a variety of fields to help them develop their idea.

Medtec Meetings enables you to organise and network with fellow attendees. The initiative allows all of our visitors and exhibitors to find and arrange meetings with key contacts prior to the event. Those meetings can be held at the different stands or private lounges organised. This intuitive, user-friendly portal allows the visitors to search for connections using a series of defining options. Medtec Europe offers a free medical device manufacturing conference. The medical devices industry is moving fast, with new innovations and products so it’s important to keep on top of regulatory issues, device advances, the latest healthcare and medical needs, issues and problems. One of the highlights is the new conference called “Cardio Unmet Needs – Clinical Meets Industry”. For the first time Medtec Europe brings R&D professionals together with clinicians to discuss the future of medical devices for cardiology. Clinical experts will openly discuss existing cardio medical devices, the issues that they have with them and the unmet needs that could be serviced by industry. Spaces are limited and are restricted to R&D professionals from medical device manufacturers working in the cardiology field and start-ups developing cardio solutions. The conference will be an interactive forum where the audience will get to share their views and questions with the clinicians – and therefore offers additional networking opportunities. Another new feature for 2016 is the Innovation Lab. This lab provides visitors with the opportunity to look at some of the most exciting areas of technical development, not just in the field of medtech but in advanced manufacturing generally. This forum will give R&D professionals, design engineers and those with a technical background the chance to learn about the latest technologies in additive manufacturing, miniaturisation, personalised medical devices and molecular diagnostics and how to apply them to their projects. Sessions are designed to be interactive and more hands on than the technical presentations taking place in the conference. Medtec Europe organisors say the event is a must for global medical device manufacturers to source technology from the experts, network with industry professionals and discover the latest innovation within the medtech industry, all under the one roof.

WWW.MEDICALPLASTICSNEWS.COM

Peel it off. Peel it ALL off. Introducing FluoroPEELZ ™ Peelable Heat Shrink

One simple linear tear is all it takes. FluoroPEELZ™ peelable heat shrink from Zeus helps medical device manufacturers increase yield and improve safety.

Visit Zeus at

Medtec Europe

April 12-14, 2016 Booth 5B11

LIVE DEMOS

For more information, visit

www.ZeusFluoropeelz.co.uk

US +1 (803) 268-9500 | Europe +353 (0)74 9109700 Asia +86 13922204986 | Latin America +1 (803) 268-9500

Brilliant performance | ENGEL medical

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

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

NEWS ANALYSIS

In the near future, a UDI (unique device identification) number will be required on all pharmaceutical products.

UDI is coming

are you ready? Richard Pether Rotech, gives an overview of UDI and some practical steps that healthcare suppliers can adopt to implement UDI using offline coding technologies

n 2013 the US Food and Drug Administration (FDA) mandated unique device identification (UDI) for most medical devices distributed in the United States. Supported by the International Medical Device Regulators Forum (IMDRF), regulators in the rest of the world are considering similar legislation.

International guidance on UDI has been developed and this will serve as the basis for the EU’s future identification and traceability infrastucture, building on the pharmaceutical pack serialisation requirements set out by the Falsified Medicines Directive (FMD), which comes into force in 2018. The aim is that there will be one, globally harmonised system for identification of medical devices - from surgical instruments, inhalers, contact lenses and dressings to diagnostic tests - by healthcare providers such as the NHS. So, for producers and packers of healthcare products, it’s no longer a question of whether item-level serialisation will become a legislative requirement in the EU. It’s a question of when.

UDI explained A UDI is a unique number or alphanumeric code that consists of two parts: a UDI-DI (device identifier) and a UDI-PI (production identifier). The DI element of the code identifies the specific version or model of a device, for example, through a GSI global trade item number (GTIN), whilst the PI element gives production data - typically batch code, lot number, expiry date or date of manufacture. This information must be presented in two formats: human readable and machine-readable. Although not stipulated by the legislation, the GS1 2D DataMatrix is frequently selected as a machine-readable carrier for UDI data. So, as an example, the UDI could consist of GTIN, batch code and expiry date encrypted in a 2D code, with the same data also presented in human-readable format. The idea is that the creator of the UDI (usually the manufacturer), submits the code to a central database, so that it can be checked at various stages in the supply chain, via a scanner or smart phone. For this purpose, the US FDA has created the Global Unique Device Identification Database (GUDID).

How it works GS1 is the main accredited issuing agency for UDIs. With the GS1 framework, every party in the supply chain is given a unique global location number (GLN), while every product that enters the supply chain is given a unique global trade item number (GTIN). GTIN and GLN data is shared electronically through a global data synchronisation network (GDSN). The

WWW.MEDICALPLASTICSNEWS.COM

NEWS ANALYSIS

â&#x20AC;&#x153;

idea is that as products pass through the supply chain, they are scanned by each stakeholder and both GTIN and GLN information is updated automatically.

Why UDI?

From a business operations and supply chain perspective, UDI should allow for improved procurement, security, inventory management and accounting.

UDI will make it quicker and easier to identify and track medical devices in the supply chain, from supplier to patient. This has a number of potential benefits - for patients, heathcare providers and manufacturers. Patient safety should be better safeguarded through a reduction in medical errors, industry and regulatory authorities will be able to identify medical devices involved in adverse events more rapidly and issue more targeted safety alerts and recalls, and the traceabililty provided by UDI should serve as an effective anti-counterfeiting measure. From a business operations and supply chain perspective, UDI should allow for improved procurement, security, inventory management and accounting.

What do I need to do? Soon, all healthcare suppliers wishing to deal with providers such as the NHS will need to apply UDI identification to their products, at an individual item level. In order to print serialised data and 2D codes, printers will have to be digitally addressable, which means any old embossing kit and the hot foil coders will have to go. Code quality is crucial for machine-readable codes, and that quality needs to be maintained from the day the code is applied to the day it is scanned by a patient or healthcare provider, which could be a year or two later. Ink fade is a potential problem, and any codes that are slightly fuzzy, blurred or outof-position might be unreadable further along the supply chain. Whilst most manufacturers will deploy an online camera-based system to verify the code, vision system performance will also be influenced by the quality of the code, and rejection and rework of any packs carrying unreadable codes will have serious implications for overall equipment effectiveness (OEE). Thermal inkjet printers (TIJs) place their pixels more accurately and offer higher resolution printing (typically 300 dpi or above) than CIJ systems. This makes TIJ the obvious print technology of choice for 2D codes. However, even where manufacturers are using TIJ, print quality is still dependent on the presenta-tion of the product to the printer. DataMatrix barcoding requires near perfect presentation to achieve the highest verification grade. As many medical devices are awkwardly shaped, feeding can be a problem, resulting in mis-coded items that cannot be validated by an online vision system or a scanner further along the supply chain.

Producing high quality serialised codes at the line speeds required by some healthcare operations is no mean feat either, and compromises between quality and speed often have to be made.

Offline coding: a consideration

For many healthcare suppliers, the answer to these issues could lie in taking coding offline. Rotech, for example, has designed a modular system that incorporates printing, labelling, inspection and automatic stack-to-stack feeding technology. This system has already been supplied to a number of pharmaceutical manufacturers in advance of the FMD, and is equally applicable to medical device manufacturers who want to implement UDI without impacting their production lines. Offline overprinting systems come into their own where a large amount of text is required or the print is required to meet an exacting standard, such as the 2D DataMatrix code on a medical device pouch. By taking this process offline, the packs are brought to the line ready printed and inspected, eliminating any delays due to coding issues. The potential for rejects is massively reduced because the pack can be presented to the printer in the most favourable orientation. Offline systems can be fitted with either a thermal inkjet or a thermal transfer printer. Many companies assume that an online system will be faster and more efficient than an offline one, but once you take into account the impact that inline verification, serialised code printing and mis-codes could have on line efficiency and OEE, offline coding starts to look like an attractive option. Speeds of up to 200 packs per minute are well within the capabilities of an offline coder, and a range of packaging formats can be coded offline, including cartons, wallets, pouches, bags, sleeves and crash-lock cartons. In fact, small batches are more efficient and economical coded offline. Systems can be positioned either near or next to a line to keep it supplied during running or can supply a second line in a central location.

Get ready for UDI From pharmaceuticals to surgical equipment, every product being manufactured by the healthcare industry will, in the very near future, be required to have a unique device identification (UDI) number. Now is the time for manufacturers of pharmaceuticals and medical devices to get their coding systems UDI ready, and offline coding could just be the best route to compliance.

WWW.MEDICALPLASTICSNEWS.COM

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

3/14/16 11:24

www.netstal.com

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

Outstanding quality High returns Engineering Excellence

NET_Anz_MED2014_EN_190x124.indd 1

WWW.MEDICALPLASTICSNEWS.COM

18.02.16 09:16

COVER STORY

All in the delivery Phillips-Medisize outlines device development for pharmaceutical and biological combo products

t this year’s Pharmapack in Paris, Bill Welch, CTO, PhillipsMedisize, presented on Integrated Development and Scale-Up of Combination Products. Welch talked about drug delivery devices becoming more user-friendly, increasingly designed as “smaller and smarter” human-centred devices. When developing a combination product, there are many considerations – the critical relationships between device development and the pharmaceutical or biologic, early establishment of regulatory and clinical strategies, understanding ‘user’ needs, determining product requirements, as well as device manufacturing variation. The drug formulation may determine how the drug moves, interacts with and is delivered through the device. Some formulations may be sensitive to molecular shearing and require slow, laminar delivery through the device, while other formulations (especially inhalers) may have high static charges that attract to plastic, requiring device materials that dissipate static electricity. Some formulations need to be developed with the purpose of the device and sterilisation method in mind. Some substances – especially peptides – are extremely heat labile where protein molecules can break apart, degrade, or get altered into a new form with high impurity profiles that can become toxic if administered. The device can have a significant impact on product performance. Welch said: “Merging a biologic or pharmaceutical regulatory requirement with device regulatory requirements to sell a product is exceedingly difficult. Few know how to do it well and that is what creates opportunities for Phillips-Medisize”. He pointed out that Phillips-Medisize gets involved in biocompatibility issues: “Sometimes we may have to certify biocompatibility, even if it’s not an implant”.

All starts with a development strategy and scaling Engaging in efficient combo product development begins with understanding the regulatory and clinical strategies to ensure the device development is well aligned with the pharmaceutical or biologic development and applicable regulatory requirements and is also in-line with the clinical milestones. An integrated regulatory/clinical strategy between the client and CMO/supplier will de-risk the product in development stage and help scale device development. In combination products, regulatory submission involves fulfilling biopharma requirements and a scaled version of the device-design history file. The extent of device development documentation can vary. Although there could be multiple modes of action, designating the one with the simplest form of intended use as the PMOA (main therapeutic component in a combination product that zeroes in on the product’s intended use) is the key to submission expediency. Depending on the PMOA and the lead FDA centre, a manufacturer may be required to undergo clinical trials using one or more of the following – investigational device exemption (IDE) for a device, and investigational new drug (IND) or 20

new drug application (NDA) for a drug. Determining the submission pathway is essential to understanding the clinical trial strategy. Consequently, that knowledge will be important in identifying the device development schedule and level of product robustness necessary to be met before submission can occur.

“

Merging a biologic or pharmaceutical regulatory requirement with device regulatory requirements to sell a product is exceedingly difficult. Few know how to do it well and that is what creates opportunities for Phillips-Medisize

The clinical strategy helps establish critical milestones for device development. Critical milestones may include things such as when feasibility prototypes or breadboard-level electronics and software development are needed. Early clinical studies, for example, may be conducted with prototype devices that produce the essential core device technology, but do not require the device to be in its final commercial configuration. There is however, a point says Welch, at which the device needs to be “production-like” and manufactured under full cGMPs, verified against the design input requirements and validated to show it meets its intended use and needs.

Understanding product needs Defining the needs of the user, business, or stakeholder is fundamental. The product must be: 1) Useful – meet a specific need 2) Usable – easy to understand and manipulate 3) Desirable – appealing to the intended user so it will be adopted into their daily use 4) Manufacturable – the process output is true to the actual value or target desired but is also repeatable. An integrated product development process combines humancentred design principles with a solid design for manufacturing philosophy. Also, appropriate levels of design research are needed in order to fully understand user needs. Combination products consist of multiple subsystems that need to be well defined to ensure the product will perform as intended. When software and electronics are an integral part of the drug delivery device, an additional layer of complexity exists. A set of requirements needs to be developed for the integration of the drug and device with emphasis on the ways each constituent part can adversely affect the other. Once the Target Product Profile (TPP) of the drug substance has been established, relating this to the materials science aspects of device development is key for stability, toxicity and ADME studies. One way of defining this relationship is in the early stages of development, through the use of Quality By Design (QbD). QbD (drug standpoint) and proof of concept (device) are not mutually exclusive. Through the development of a design

WWW.MEDICALPLASTICSNEWS.COM

Integration of the Drug and Device

Device development companies need to understand the mechanics of drug dispersion (e.g. aerosol, transdermal, subcutaneous) to identify key device features that may impact drug delivery. Drug development companies need to understand the nature of device manufacturing and variation as well as pay close attention to the material selection as it could impact drug delivery and drug performance. Both groups need to understand the iterative nature of device develop-ment and clinical nature of drug development, so that these critical interfaces can be identified, quantified and stabilised as early as possible in order to generate robust clinical data.

Device Performance

Drug Performance

Requirements that focus on the drug alone typically describe how the molecule and formulation need to be configured such that the drug will have its desired affect once it is interacting with the patient. Those requirements often include pharmokinetics, pharmodyanmics and other pharmacological performance definitions.

Describes how the device will interact with the user and how the drug will be readied for delivery. It is worth noting that human factors engineering, design research and industrial design (collectively known as human-centred design) all have a significant role in establishing these device requirements. Formal usability studies conducted early in the development process should inform the device design as much as the technical performance studies.

space, QbD helps establish the target product profile (TPP) of the drug substance. But the design space for the TPP could be impacted by the properties of materials (drug delivery device) where product contact is made. This potential interaction over time (stability) can alter the efficacy of the drug, sterility, etc, which lowers the efficaciousness and effectiveness of the drug product for therapeutic effect.

Container closure system Devices are often considered a part of or the entirety of a container closure system (CCS). Per FDA Guidance for Industry-Container Closure Systems for Packaging Human Drugs and Biologics: “A container closure system refers to the sum of packaging components that together contain and protect the dosage form. This includes primary packaging components and secondary packaging components,if the latter are intended to provide additional protection to the drug product.” This distinction is important as the vials, ampules, bottles or moulded components that a company may use to house a drug must be tested in conjunction with the drug and be considered a ‘whole’ throughout the product development process. Drug product integrity and effectiveness are important aspects for why CCSs need to be thoroughly tested against edge-of-failure conditions. Any potential breach of a CCS for a sterile product, parenteral, or injectable could introduce by-products, etc that could impact the drug product stability profile. This could make the drug product less effective and / or cause adverse reactions. The CCS must be designed to allow for the integrity of the product all the way through the supply chain until the end of expiration. A liquid vial and plunger in a spring-loaded syringe highlights how the container closure system can impact product performance. The drug development team may specify the vial that will be used and how much time is allowed to deliver the drug, while the device development team must characterise the amount of force needed to push the plunger to extrude the drug through a needle of a certain diameter in a set amount of time.

Device manufacturing variation We know device A is not the same as device B when viewed on a micro-scale. This is where specifications come into play. A device will be manufactured to specifications that most commonly control the size of a feature and/or its position relative to another feature. This is important from a pharmaceutical or biological

background. A device comprises multiple components, with every feature requiring some level of manufacturing tolerance, so there device performance variation can alter. Specifications are derived from requirements however, specifications are not requirements themselves. If the requirement of a spring-loaded syringe is to deliver the drug within 1-2 seconds of actuation, the device team must create manufacturing specifications and tolerances that will create this result. When software and electronics are involved, complex algorithms may be developed early on to perform a function using one, two, or three prototype devices. But during development the software and electronics team needs to understand the manufacturer’s tolerances for sensors, processors etc, as well as for any moulded or fabricated components. Software development may require on-going development as additional units are produced and additional component variation begins to enter the picture. It’s important not to overlook the regulatory expectations regarding configuration management for medical devices with software platforms.

The right tolerances for different features This is where design for manufacturing comes into play. When making a single component or a low volume of components, often smaller tolerances can be achieved. In higher volumes, more variation is inserted into the manufacturing process, including but not limited to, multiple cavities for tools, different operators and multiple assembly lines. At this point process optimisation begins prior to transfer. Once the initial specifications and tolerances have been established (with manufacturing input), parts can be prototyped at their specification limits in order to determine if these tolerances are appropriate. According to Welch, Phillips-Medisize’s goal is, “to partner with large and small biopharma companies, helping them to design, develop and manufacture their drug delivery devices. The partnership typically starts early on in the design phase; so by the time the drug is brought to market, we have already been working with the company for years and are well positioned to provide a low-risk manufacturing launch.” Phillips-Medisize is becoming more involved with drug handling, and it manufactures finished and labeled combination products, including products with cold chain requirements, UDI, and serialisation.

Inhalation Activated Trigger

To ensure a combination product will perform as intended, the multiple subsystems need to be well defined and understood

User Interface (Mouth Piece)

User Interface (Dust Cap)

Drive Mechanism Cocking Canister Activation

Stem and Opening

Drive Mechanism (Spring) Successful Targeted Drug Delivery User Interface (Dose Counter)

Dose Counter Mechanism

Canister Design or Drug Formulation

WWW.MEDICALPLASTICSNEWS.COM

Lower costs. Reduce the development cycle. Improve performance. Realize your vision with the most experienced and dedicated team in the industry.

MicroLumen.com

Specialist in elastomers and polymers+ for healthcare MELITEK offers innovative range of meliflex elastomer and polymer+ compounds specially designed and manufactured to meet the stringent requirements of medical devices and pharma packaging applications. meliflex is available for film, tubing and moulding applications and is offered in following ranges: XC | customized compounds meliflex XC are customized polymer+ compounds offering enhanced properties for added value and performance. XP | polyolefin compounds meliflex XP are unique flexible polyolefin compounds specially designed for PVC-free solutions based on >25 years of experience. XR | elastomer compounds meliflex XR are soft TPE compounds specially designed for rubber-like properties while offering easy processing allowing freedom in product design.

Meet us at MEDTEC Europe 2016 Stuttgart, Germany 12 - 14 April 2016

3B03

meliflex is manufactured in accordance to GMP and offered with an extensive medical service package. meliflex is PVC-free, DEHP free, latex free and meet ISO 10993 and USP test requirements. meliflex is produced and sold globally by MELITEK. For further information about meliflex, please visit www.melitek.com

WWW.MEDICALPLASTICSNEWS.COM

MELITEK A/S Hartvig Jensensvej 1 DK-4840 Nr. Alslev Denmark Tel. +45 70 250 255 sales@melitek.com www.melitek.com melitek @melitek.com

THE YEAR AHEAD

VOCAL

exercise

Who are you and what do you do?

Q&A

I ’m Stephanie Berman, owner and founder of Berman Innovations; my product, The Semenette is now known as ‘POP by The Semenette’. The Semenette was invented by combining my knowledge and expertise in women’s reproductive health, along with my hope of conceiving a child with my wife, which we were able to do with our prototype. Three years later we have successfully launched the second iteration of the toy, which we were able to use to conceive our second child! In those three years, we have found there are many other markets for which POP is ideal; the new version of the toy reflects those applications. Additionally, for the last 14 years, I work and own my family business, Sepal Reproductive International, which specialises in women’s reproductive health.

How would you sum up your company?

My company is small, but we do it all! We manufacture, distribute, market, sell, and innovate. I also spend a portion of my day personally answering emails from customers. It gives me a chance to directly communicate with those who are using the product; there is no better R&D than the dialogue I have with consumers.

Name a business achievement you are most proud of.

Having retailers bring POP into their stores has been a huge accomplishment; because the market is saturated, retailers set themselves apart by only bringing in products they wholeheartedly believe in. It’s a testament to the quality and technology of my product, and for that, I am very proud.

WWW.MEDICALPLASTICSNEWS.COM

My partnership with Fun Factory has also been a huge achievement. Having a manufacturer, with an established track record of product excellence, embrace my toy and its technology is a dream come true. Fun Factory is one of the best pleasure products manufacturers in the business, and to have my product stand alongside theirs is simply fantastic.

What excites you about this industry?

Companies adopting available technologies and incorporating them into pleasure products, is extremely exciting. Of course, I’m so pleased that pleasure products companies are thinking beyond the orgasm, to actual health and medical applications. I also love how companies are expanding toy design and technology to meet the needs of everybody. We weren’t all born with one shape, size, or ability, and each person has different needs; it’s nice to see all communities being considered.

Where do you predict industry growth will come from over the next 12 months? I think we are going to continue to see the industry growth come in the form of expanding and utilising technology as much as possible.

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

I would have to choose The Hummingbird Tympanostomy tube system. As a mother of two and having many friends whose children have had to endure getting ear tubes, this device stands out. Anything to help lessen the pain and invasiveness of a procedure for children is a winner in my book!

Maybe viruses in the blood will soon be a thing the past. Maybeofviruses in the blood will soon be a IN TOUCH WITH PLASTICS thing of the past. IN TOUCH WITH PLASTICS

Why set limits when the future is open? At present, plastics already offer antibacterial protection and meet the strictest requirements medical What is there to Why set limits when theinfuture is technology. open? keep intelligent plastics from ALBIS from actively fighting viruses At present, plastics already offer antibacterial meet one day? Our potential in the healthcare field protection is far fromand exhausted. the us strictest requirements in medical technology. What is us there to Let provide inspiration for the industry together – join keep plastics on ourintelligent way to the future!from ALBIS from actively fighting viruses one day? Our potential in the healthcare field is far from exhausted. Let us provide inspiration ALBIS (UK) Ltd. for the industry together – join us Parkgate Industrial Estate · Knutsford on our way to the future! GB-Cheshire WA 16 8XW Phone: +44/(0)1565/755777 Fax: +44/(0)1565/755196 ALBIS (UK) Ltd. albisuk@albis.com in Ireland: ireland@albis.com Parkgate Industrial ·Estate · Knutsford www.albis.com GB-Cheshire WA 16 8XW Phone: +44/(0)1565/755777 Fax: +44/(0)1565/755196 albisuk@albis.com · in Ireland: ireland@albis.com www.albis.com

SPOTLIGHT ON INNOVATION

BRIGHT LIGHTS

MPN SHINES A LIGHT ON SOME OF THE SECTOR’S BRIGHTEST INNOVATION

It’s a kind of magic

RESPONSE UNIT

Wearable saves lives on the battlefield

Wand connects medical devices to wifi

n the US, Dartmouth College has developed Wanda, a device that can read wifi passwords and transfer this information to medical devices wirelessly. The Wanda prototype can acquire a network name and password by being plugged into a wifi router. To transfer the wifi data to the medical device Wanda is detached from the router and pointed at a medical device – because the medical device is close to the wand, it can reconstruct the information. However, a hacker further away could not. Wanda, is part of a multi-university project to develop ways to protect patient confidentiality as healthcare increasingly moves out of hospitals and doctors’ offices and into the home. But beyond safety, simplicity also is a key goal, said doctoral student Tim Pierson, Wanda’s creator to ABC News. Pierson said: “Quite frequently in the computer security business, we invent things that are super-secure but hard to use and people don’t understand them: We set out to make something that my parents and in-laws could use.” With Wanda, a doctor could send a patient home with a wifi enabled blood pressure cuff and instead of having to type in a passcode to connect the monitor to a home wifi network, the patient just points Wanda at the device. Once that connection is made, blood pressure readings can be transmitted back to the doctor’s office, reported ABC News.

Fighting chance: The First Response Monitor by Cambridge Design Partnership, is designed to help medics monitor both heart rate and respiratory rate

he First Response Monitor by Cambridge Design Partnership, is designed to help medics monitor both heart rate and respiratory rate.

According to Cambridge Design Partnership respiratory rate is often neglected by automated monitoring systems. However, the benefits of accurately monitoring respiratory rate are clear and when combined with other parameters, such as heart rate and body temperature, can indicate life-threatening conditions such as sepsis. When designing the new compact device, Cambridge Design Partnership interviewed a range of army medics about their needs and challenges in multiple casualty emergency situations. An unmet need was identified for a low-cost device to bridge the gap between manual methods of vital signs measurement and more expensive patient monitoring systems. The First Response Monitor is a lightweight, robust and low-cost wearable biometric device which monitors patients and collects, then transmits, data in real-time. This enables the medic to care for a greater number of casualties, providing more effective casualty triage to deliver improved patient outcomes. The small device clips onto a patient’s nose and monitors breathing rate and heart rate, giving ‘at a glance’ indication of both parameters. This data can then transmitted using bluetooth to a smartphone app or tablet, enabling data analyses such as individual patient trend graphs and multiple patient triage or situational awareness across the group. James Baker, partner, Cambridge Design Partnership said: “With the First Response Monitor we’ve combined our expertise in wearable connected devices with our extensive medical experience to develop a technology for effectively measuring breathing and heart rate. “The monitor can help save lives in a variety of environments and we’re really keen to speak to partners about developing the potential applications further.”

WWW.MEDICALPLASTICSNEWS.COM

HIGH PERFORMANCE POLYMERS

Selecting performance plastics

To make an intelligent material selection for a medical device with a performance plastics there are several questions to ask, especially at the beginning of a project, when the parameters may not be finite or well known. Selecting the ideal performance materials can be challenging. Modern Plastics can assist in the material selection process, provide data and samples as needed to help customers select the best material for their application. There are of course, certain things to consider. For example, do you need to see through it â&#x20AC;&#x201C; that is, should the material be transparent? What is the operating temperature? Does it have to have to be chemical or corrosion resistant? We would also consider what the tensile / load requirements are, if any specific characteristics are needed and what the special needs are of the project. If the material needs to meet any certifications such as ISO 1099, we would include that in the selection as well as the planned method of manufacture. On top of this we would look at what is motivating or driving interest and of course, cost considerations come into play.

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

SPOTLIGHT ON INNOVATION

Passing the test

Google develops bandage-sized glucose monitor

he collaboration will pair DexCom’s sensor technology with Google’s miniaturised electronics platform to create the G4 Platinum Receiver. The G4 Platinum Receiver, for continuous glucose monitoring, will have a bandage-sized sensor that will be connected to the cloud. Kevin Sayer, president and chief executive officer of DexCom, said: “This partnership has the potential to change the face of diabetes technology forever. “Working together, we believe we can introduce products that will move us beyond our core type 1 business to become the standard of care for all people living with diabetes.”

Sweet talk: The G4 Platinum Receiver, for continuous glucose monitoring, will have a bandage-sized sensor that will be connected to the cloud

Food for thought: The S’Up spoon has been designed for people with conditions such as cerebral palsy

S’up’ with your spoon?

inding it almost impossible to eat with normal cutlery due to having cerebral palsy, Grant Douglas worked with industrial designer Mark Penver, from the Glasgow-based agency 4C Design, to create the S’Up spoon with a deep capacity for people with shaky hands. With the financial backing secured through a Kickstarter campaign the group contacted Proto Labs, which sent out a free material sample kit, so that it could start to select suitable materials and finishes. It was determined that polypropylene, or ABS with a beaded finish, provided the best surface finish as it allowed the food to freely slip out of the spoon head. Penver said: “The advice offered by Proto Labs proved to be very helpful and they

were patient during the quoting process – even though we went through 20 or more iterations as the design evolved.” He went on to explain that selecting a UK manufacturer was important to his team so visited Proto Lab’s Telford manufacturing base for a tour of the facilities. Penver said: “It was mind blowing that parts could be produced in just one day and their approach has saved us a considerable amount of money. “Using Proto Labs we’ve been able to get the S’up Spoon out into the market much faster and not just improve the lives of people with cerebral palsy but those with similar symptoms such as essential tremors and Parkinson’s disease.” The success of the S’up Spoon has led to 4C Design forming a company with Grant Douglas called S’up Products.

WWW.MEDICALPLASTICSNEWS.COM

DEVICE BATTERIES

Power D

octors, surgeons and healthcare practitioners are increasingly calling for medical technology (medtech) original equipment manufacturers (OEMs) to address problems with the battery life of implantable medical devices (IMDs). Key concerns include the risk of infection for patients needing to undergo frequent surgery to replace batteries and a need for battery life to be raised to a minimum of 25 years alongside calls for the industry to incentivise longer product development lifecycles (PDLCs).

Neil Oliver Accutronics, looks at techniques that can be applied to increase the longevity of medical device batteries

If you want to see evidence of the demand we now place on the humble battery, simply take a minute to look at your smartphone. The battery is now expected to provide a continuous, often high-discharge, power supply for components including a backlit capacitive touchscreen, front and rear cameras and LED flash, speakers, microphone, wifi antenna, graphics card, and the CPU at the core of the device. In essence, your average battery powers a device that has more computing power than the original Apollo rocket that took men to the moon. Combined with the demand for smaller, thinner, and lighter batteries in consumer electronic devices, it shouldn’t be surprising that most phone batteries don’t last more than one day per charge. The trend for more frequent evolutionary, rather than revolutionary, hardware updates has resulted in shorter product development lifecycles (PDLCs) of one year or less in the consumer industry, something that is also beginning to affect medical device development. The continued push to cut costs and improve efficiencies in the medical industry means that products are expected to last anywhere from ten to fifteen years to lower the total cost of ownership and increase return on investment. However, increased use of portable, wearable, and implantable devices means that the batteries need to step up, as they will be required to last for up to 25 years or more.

Although Accutronics specialises in batteries for portable rather than implantable medical devices, these problems affect the industry across the board. Improvements in battery life, battery density, protection circuits, smart features, and sustainable design engineering are all necessary if we want to increase longevity.

“

The battery is now expected to provide a continuous, often high-discharge, power supply for components including a backlit capacitive touchscreen, front and rear cameras and LED flash, speakers, microphone, wifi antenna, graphics card, and the CPU at the core of the device.

Medtech challenges Portable and wearable medical devices are often designed to include removable, rechargeable batteries making it possible to replace a battery without replacing the device. However, the same rules clearly do not apply when it comes to implantable devices, where the embedded battery cannot be replaced, meaning the entire device needs to be surgically removed and replaced. Doctors in the British Medical Journal (BMJ) recently highlighted this problem. Cardiologists John Dean and Neil Sulke have argued that the battery life of implantable medical devices (IMDs) needs to be longer to avoid the frequency of surgery currently required and to remove the subsequent risk of infection. They have also

called for IMDs to have greater accuracy when it comes to monitoring remaining battery life, and argue that devices could be made bigger to hold more charge.

However, many OEMs leave battery selection as an afterthought in the design and development process. The US Food and Drug Administration (FDA) has expressed concerns about batteries in medical devices in recent years, stating problems in three key areas; insufficient quality assurance in medical devices, a lack of knowledge integrating batteries into medical devices, and limited knowledge about when to replace the battery.

A tall order

So what are the requirements of portable and implantable medical devices? Batteries are now expected to last anywhere between 5-25 years and be safe throughout installation and use. They must provide accurate stateof-charge information, be highly reliable with predictable discharge profiles, and use battery chemistry that is suitable for the application. They must also be able to handle high temperatures, both inside and outside the body, and we will increasingly see high volumetric and gravimetric densities being employed to deliver smaller devices with a longer battery life. To see how we can increase longevity, it is important to get a better understanding of specific devices and their requirements. External devices such as portable ventilators, anaesthesia machines, intraoral scanners and automated external defibrillators are designed to replace the need for mains power, so they typically use Lithiumion (Li-ion) cells that deliver continuous high-discharge power, with batteries that need to be charged weekly, if not daily. Our own CMX battery is designed for this purpose. The battery is available in three versions, using eight, twelve or sixteen ‘18650’ sized cells, with continuous discharge rates of up to 300W.

WWW.MEDICALPLASTICSNEWS.COM

Rangers Smart features, like those in our CMX series, ensure delivery of core requirements. These include active and passive protection circuits that prevent over-temperature, over and under-voltage, overload and short circuit. Forming an essential part of medical device operation, smart power management means the battery only requests charge when needed and shuts down when not being used. Accurate fuel gauging is possible to within 1% through an LCD display, further enhancing reliability. An average battery powers a device that has more computing power than the original Apollo rocket that took men to the moon, says Neil Oliver Accutronics

A lesson in chemistry On the other end of the spectrum, we have implantable medical devices (IMDs) with power ratings less than one ampere, often in the milliamp and microamp range. As well as requiring batteries that can last for years without being recharged, IMDs include a range of devices, such as neurostimulators, cochlear implants, implantable cardiac defibrillators (ICDs), cardiac resynchronisation therapy (CRT) pacemakers, and drug delivery systems.

IMDs typically use lithium/iodine batteries in the microampere range, lithium/manganese oxide in the milliampere range, and silver vanadium oxide (SVO), in the one ampere range and over. The majority of these battery chemistries have been around since the early 1970s and have been refined over the years by tweaking the use of electrolyte in liquid and solid forms and by using hybrid cathode materials such as coating SVO with carbon monoflouride for higher power delivery. Despite these improvements, it is important to remember that a battery is a consumable part that will degrade over time. This is why choosing the right battery chemistry is vital. The discharge characteristics of a battery change over time with changes to the electrolyte’s conductivity and impedance. Batteries can also slowly self-discharge when in storage, and exhibit calendar and cycle fade, where the battery performance drops with age. Design engineers don’t usually have to be concerned with these problems because Lithium-ion batteries typically deliver between 300-500 charge cycles before performance drops, by which time the device is most likely at the end of its lifecycle or a removable battery can simply be replaced. However, this isn’t viable with implantable devices. Here, design engineers must very closely examine the affects of chemistry on the discharge profile and calendar life of the battery.

“

This is easier said than done for some implantable devices. ICDs, for example, need to provide a continuous low-current monitoring function as well as high-pulse currents of 2-3A to charge the capacitors when delivering a high-energy shock to the heart. This is like asking a long-distance athlete to do multiple 100m sprints over the course of a 5000m race. Not an easy task.

As well as requiring batteries that can last for years without being recharged, IMDs include a range of devices, such as neurostimulators, cochlear implants, implantable cardiac defibrillators (ICDs), cardiac resynchronisation therapy (CRT) pacemakers, and drug delivery systems.

By considering how the discharge profile will change over time, design engineers can create a model that can accurately predict the end of the battery’s life. This will prove particularly important in overcoming the issue of early surgery for patients whose ICDs are still capable of delivering many high-discharge pulses. Two of the biggest enemies of energy dense batteries such as lithium-ion are high temperatures and storage at a high state of charge. These two variables can quickly degrade cells and cause permanent damage. If batteries are stored at high temperatures, or if the storage period exceeds 12 months, the internal protection electronics will enter a ‘hibernation mode’ to protect internal cells from damage caused by over discharge. The same principle can be developed and applied to protection circuits used in IMDs that require infrequent application, reducing battery drain.

The future Continued innovation by medical device OEMs will create further incentives to develop longer life batteries. New research into nano-materials and charging technology is already paving the way for flexible, self-healing batteries with reversible chemistries that will offer incredibly long lifespans as well as fast and wireless inductive charging. While this technology is still in the very early stages of development and requires many years of reliability testing before it can be used widely, it will open up sectors beyond the medical industry into wearable, healthcare and patient environments, providing OEMs with further profitable avenues. Maybe then our phones can focus on being phones rather than pseudo-medical devices and make it through more than a day on a full charge.

WWW.MEDICALPLASTICSNEWS.COM

POLYMERS VELOX EXPERTISE

WE UNDERSTAND MEDICAL • Raw materials supplier • Small quantities just in time • Technical advice at design stage • Change management • Regulatory support • Customised polymer solutions

VELOX GmbH +49 (0)40 369 688 0 medical@velox.com www.velox.com

WWW.MEDICALPLASTICSNEWS.COM

HIGH PERFORMANCE POLYMERS

4 things to think about

Clear view: Devices made from crystalclear material provide healthcare personnel with unobstructed views

when choosing a high performance polymer…

oday’s medical device designers and original equipment manufacturers (OEMs) are increasingly under pressure when developing or improving medical devices. One of the biggest decisions they make is selecting a material for their device — the right choice helps meet the end-user’s while the wrong Cedric Perben, needs choice can lead to issues EMEA medical later.

application development, Eastman Chemical Company explains

High-performance polymers are the future of medical devices, as they help better address patient needs and last longer. However, the choice doesn’t end there. Key considerations still need to be made when selecting the most appropriate highperformance polymer for device design. These considerations often include ensuring the material offers chemical resistance, sterilisation stability, design flexibility and superior clarity. Another key consideration is finding a supplier that offers much more than just a product. From project initiation to product launch, offering technical expertise and sharing application development insights can help ensure a high-performing polymer is right for a specific device.

Check the boxes A checklist is the simplest way to ensure a material is meeting a device’s every need, especially when navigating the many advantages of high-performance polymers. Cipher Surgical made sure to check all of the boxes when improving its OpClear

device, ultimately selecting Eastman Tritan copolyester. To eliminate the need to remove a laparoscope from a patient during surgery, OpClear allows a surgeon to clean the lens of collected liquid, fatty residue and other contaminants with a short, controlled jet of carbon dioxide and saline. By decreasing, or even eliminating, the necessity to remove the laparoscope for cleaning, the device reduces operative time and maximises patient safety. 1. Will your device need to withstand contact with harsh drugs and destructive disinfectants? As more hospitals are pushing to reduce cases of infections and treating patients with the best medication available, many devices need to be able to withstand aggressive disinfectants and harsh drugs, such as those used for oncology patients, without breaking down. In fact, hospitals are standardising the use of harsh disinfectants in their processes to ensure simplicity and consistency. Although the first generation of OpClear was a success, the device was made with nylon, which reacted poorly to certain cleaning chemicals, inhibiting the product’s full potential. To prevent the device’s early breakdown, Cipher chose Eastman Tritan copolyester for their next-generation device. The material is resistant to a large spectrum of fluids used in hospitals, including aggressive cleaning disinfectants, powerful drugs including those used in oncology, drug carrier solvents and lipids. This resistance helps decrease the risk of the device cracking and discolouring, therefore increasing patient safety. 2. Will your device need to undergo sterilisation and come out unscathed? Many devices used in hospitals need to undergo sterilisation processes — such as e-beam, gamma radiation and ethylene oxide (EtO) methods – to reduce the bioburden to a safe level while also minimising changes to the final product’s physical and optical properties. These processes can affect a device’s colour and clarity, and also cause cracking and loss of critical properties. A material must be able to withstand sterilisation processes and remain unscathed after repeated uses. When redesigning OpClear, Cipher needed a material with sterilisation stability because the device underwent these processes prior to every use. Eastman Tritan copolyester is resistant to sterilisation techniques without

WWW.MEDICALPLASTICSNEWS.COM

jeopardising the polymer performance, offering no risk of colour shift to yellow – which can cause devices to be seen as contaminated – and no physical property malfunctions. 3. Will you need to see the substances inside your device? Devices made from crystal-clear material provide healthcare personnel with unobstructed views that let them more easily — and quickly — see foreign substances, bubbles, fibres from sanitising cloths and fluid levels, which helps keep patients safe. OpClear, a material with superior clarity allowed for visual confirmation that the device was working, as well as helped keep the laparoscope visually similar to what surgeons are used to. Eastman Tritan copolyester offered the clarity Cipher was looking for, especially as the material remains just as clear after the device’s intended use and sterilisation. 4. Will you need additional support in terms of technical expertise and application development? To better understand how a material can be worked to fit specific design needs and how it should be tested, designers and OEMs can consider aligning with established companies that have expertise in these new materials and are willing to work together. Collaboration from the onset — and throughout the value chain — can help ensure the right material is selected, the design process runs smoothly and the product is brought to market as seamlessly as possible. To improve the original OpClear, Cipher worked closely with Eastman’s technical and application development experts and those from moulding company Ci Medical Technologies. The collaboration ensured each company’s expertise was used to optimise the moulding process with the new material.

Reviewing the checklist Access to high-performance polymers that better address customer and end-user needs allows designers and manufacturers to meet the growing demand for medical device innovation. With some simple considerations – and by using an easy checklist to make sure a material meets a device’s needs – designers and OEMs can better assess which material is right for them. 31

A focused European event for medical device manufacturers and healthcare professionals to source technology and innovation Medtec Europe shares the latest product developments, research and innovations in healthcare. It features an enhanced education programme showcasing case study led seminars, product demonstrations and panel discussions which JCXG DGGP KFGPVKĆ&#x201A;GF CHVGT EQPUWNVCVKQP YKVJ CP industry advisory board. Make sure you pre-register for free!

12-14 April 2016 Messe Stuttgart, Germany

Find out more about the event or to register to attend, visit: www.medteceurope.com/europe Other events include:

Join the conversation @MedtecEurope

HYDROGELS

Water World A

hydrogel is like a molecular sponge. In looking at a hydrogel material one sees what looks like a solid form. However, the hydrogel has tiny pores throughout its structure that are interconnected to create a vast network of pathways for water and other small molecules Jason Smith, to be absorbed and retained. Common uses of hydrogel materials include wound care senior analytical management, aiding in tissue repair, drug chemist, Polymer delivery, cartilage replacement, and as the Solutions, looks material of choice for contact lenses. While at understanding hydrogels have been utilised within the life sciences industry for over 50 years their necessary increased use is poised to grow as these analytical materials are better understood and tailored techniques of to have novel functional characteristics. hydrogels Chemical analysis and physical testing of hydrogels ensures that the material will perform as expected and most importantly that it will be safe for the patient. According to Gulrez et al (2011) there are three important characteristics for a hydrogel. These characteristics are the hydrogelâ&#x20AC;&#x2122;s water holding capacity and permeability, dissolution rate, and its biocompatibility. First, the hydrogel must have the ability to hold water to be effective. Therefore knowing its capacity lets you know how much water the hydrogel bonds to the hydrophilic groups and how much water is bound through the materials hydrophobicity. Secondly, when the hydrogel is in place it needs to either deliver or direct changes in the system. This means that small molecules need to migrate out of the hydrogel, as in drug delivery of active pharmaceutical ingredients (API), or that the hydrogel needs to dissolve, as in keeping an area moist for tissue repair. The dissolution rate itself must also be reliable and appropriate for the specific application. Thirdly, the biocompatibility needs to be understood to ensure that the hydrogel can be degraded within the body without producing any toxic substances. The dissolution products should be processed normally by the body without complications.

Man at work: A scientist at the GPC instrumentation

properties are defined for a hydrogel, it is important to evaluate the quality of the end product through proper testing protocols. Validated test methods should be followed to assure the hydrogel will meet all critical performance specifications. There are multiple analytical options that should be considered for the testing of hydrogels during development, implementation, and commercial production. Fourier Transform Infrared (FTIR) Spectroscopy is a nondestructive technique that allows the user to identify molecular species in a sample matrix. In order to determine if the correct polymer system is being used in the hydrogen, FTIR spectroscopy is employed to confirm the proper molecular structure. FTIR spectroscopy can also be used to confirm the identity of any other species that are present in the hydrogel material whether or not they are meant to be in the matrix.

Properties of hydrogels

Gel Permeation Chromatography (GPC) is utilised to determine the molecular weight distribution of a polymer or macromolecule. For hydrogels GPC is used to determine the molecular weight distribution of the non-crosslinked polymer fraction of the hydrogel. This analysis gives an indication of the crosslinking efficiency for the hydrogel polymer fraction.

Defining the hydrogel properties must be done carefully and methodically during the R&D phase, with analytical testing to confirm material performance. Once the desired

Microscopy techniques can be used to look at surface characteristics of hydrogels. More specifically, Scanning Electron Microscopy with Energy Dispersive Spectroscopy

WWW.MEDICALPLASTICSNEWS.COM

11920 Elbow Connector Barbed 11926 T Connector Barbed

12045 Flange with Barb

11766 FLL to Barb Connector with Wings

80150 Needleless Injection Site Swabbable FLL MLL

97401 Universal Catheter Connector

13617 Pinch Clamp

12687 Rotating High Pressure MLL Connector

32400 Valved Tear Away Introducer Sheath with Dilator

80132 Needleless Injection Site Swabbable FLL

90404 Closed MLL to Barbed Valve Connector

17682 FLL MLL Connector Stylet Port

80506 Check Valve Barbed Inlet MLL Outlet

80191 Swabbable Pre-Slit Transfer Valve

80465 Tuohy Borst Adapter Flat Cap ML with Spin Lock

Side View

99895 3-Way Stopcock FLL, MLS Tubing Port with One Way Air Check Valve

23261 Spike, Vented Vented Cap FLL Connector 12622 3 Channel Multi-Cavity Clip

80462 Hemostasis Valve Y Connector MLS FLL Sideport

80461 Tuohy Borst Adapter Swivel MLL, Side Port Tubing, FLL Connector

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

Log on to Qosina.com to order today! Qosina stocks thousands of OEM single-use components and offers excellent customer service including free samples, low minimums, and immediate delivery. +1 631-242-3000

qosina.com

info@qosina.com

2002-Q Orville Drive North, Ronkonkoma, NY 11779

HYDROGELS

(SEM-EDS) can be employed to look at surface of the hydrogel and to confirm composition of additives to the hydrogel matrix. Whereas TEM is utilised to look at structure, pore size, and dispersion of fillers in a hydrogel. This analysis can be utilised with a quality assurance application to ensure that the end product is uniform.

Water holding capacity Hydrogel water holding capacity is an important property to understand fully, this is quantifying the components of the hydrogel and determining Hydrogels are the amount that is water and the amount that is gel. This technique poised to improve is done with a wet chemistry quality of life technique of immersing the and promote hydrogel in water or mildly better patient alkaline water and then drying off the water. The fraction that outcomes but can remains is the hydrogel content only do this when of the material. supported by Swelling determines how much great analytical water a hydrogel can hold. This is particular useful for wound science and the care applications in which proper laboratory the hydrogel needs to absorb techniques. large amounts of fluid. It is also very relevant to industries that use hydrogels for hygiene applications such as adult incontinence products. To determine this, a hydrogel dried to it polymer fraction and then allowed to absorb water for twenty four hours and the weight change is calculated as the amount of swelling.

â&#x20AC;&#x153;

Importance of patient safety Patient safety is always a critical consideration when developing products for the life sciences industry. After a hydrogel is produced it must be tested to ensure that no residual or unwanted compounds remain in the matrix that will be exposed to body tissues. There are impurities that could have a toxic effect at very low concentrations. Extracting the hydrogel in water or other suitable solvent and subsequent analysis is prudent. Extracts can be analysed by several chromatographic techniques to determine the molecular structure and concentration of residual solvents and chemicals that are present in the hydrogel matrix. Chromatographic techniques that can be utilised include high performance liquid chromatography (HPLC), liquid chromatography mass spectroscopy (LCMS), gas chromatography (GC), and gas chromatography mass spectroscopy (GCMS). If the hydrogel is designed for drug delivery it must be tested for the presence and amount of the medication. The drug must be extracted with a suitable solvent and then identified and quantified by the appropriate technique such, as FTIR or LCMS or GCMS. Another important parameter to measure is the rate of drug extraction. If the drug is to be time released, leachables testing is utilised to determine the rate at which the medicaments or active pharmaceutical ingredients migrate out of the hydrogel matrix.

Spot on: The FTIR, a non-destructive technique that allows the user to identify molecular species in a sample matrix

As the use of varying types of hydrogels increase, there is a need to define testing procedures that ensure the safe use of these useful polymer matrices. Understanding the structure and functionality that they contain is important to build the proper knowledge base. Hydrogels are poised to improve quality of life and promote better patient outcomes but can only do this when supported by great analytical science and the proper laboratory techniques.

REFERENCES Syed K. H. Gulrez, Saphwan Al-Assaf and Glyn O Phillips (2011). Hydrogels: Methods of Preparation, Characterisation and Applications, Progress in Molecular and Environmental Bioengineering - From Analysis and Modeling to Technology Applications, Prof. Angelo Carpi (Ed.), ISBN: 978-953-307-268-5, InTech, Available from: http://www.intechopen.com/books/progressin-molecular-and-environmental-bioengineeringfromanalysis-and-modeling-to-technology-applications/ hydrogels-methods-of-preparation-characterisationandapplications

WWW.MEDICALPLASTICSNEWS.COM

Your No.1 Choice for Medical Device Production

• Ultimate Precision • Excellent Repeatability • Proven Reliability

FANUC ROBOSHOT for the

Medical industry With human lives sometimes at stake, quality, reliability and repeatability are critical to the production of medical products. Products moulded for medical applications are also often transparent, making gas venting and changes in viscosity important issues. FANUC’s highly sensitive pre-injection process resolves these issues, with ROBOSHOT’s smart AI Metering Control function compensating for variations in viscosity to ensure consistent results whatever the process. What is more, because ROBOSHOT is equipped with 6 different screws as standard, manufacturers can easily alter production to accommodate different types of product.

WWW.FANUC.EU

WWW.MEDICALPLASTICSNEWS.COM

bVg`Zi^c\5[VcjX#Xd#j` gZ[ZgZcXZ CFH&)',

MED-TECH INNOVATION

CENTRE POINT C

olin Martin, show founder and organiser commented: “We are very excited about this year’s event and have a busy time of Plastics-based preparation ahead. The key thing for the businesses are an sector now is to get increasing part of the April 20-21 dates into the diary and to the annual MTI make sure of your Expo (Med-Tech exhibition space.”

Innovation) show. This event takes place in Coventry on 20 and 21 April

According to Martin: “Expo 2016 is the only UK medtech show this year. Demand is therefore expected to be high.”

Once again Expo will feature the Medilink National Awards (on the evening of April 20) together with a series of seminar events and a two day national conference for the industry. Expo conference proceedings will be opened by Gary Stapleton of 3M and will see participation from leading lights such as Johnson & Johnson, MHRA, Defence Medical Directorate, Philips, Jellagen, Glyconics and others. Martin said: “It’s important for Expo to lead on the issues facing the sector and thanks to the expertise and recruiting power of the Medilink organisation we are very well stocked this year with expert opinion – right across the board.” The finalists for Medilink’s awards are set to be announced shortly and the organisation has landed a coup by recruiting Dr Paul Sinha, writer, national broadcaster and veteran of the alternative comedy circuit. Last year’s Expo was significant in for the levels of new business conducted there. Steve Gibson for example, sales director at cleanroom supplier, NGS, said: “We were extremely impressed at the professionalism of the event organisation and most importantly

we were blown away by the quality of the visitors who attended our stand over the two days. Six months after the event, we have secured two large projects with companies we met there and we are at the advanced stages of negotiation with another contact made. We will definitely be exhibiting again in 2016.”

The machine as a whole has also been provided with a water cooling system with a closed cooling circuit, special alcohol- and solvent-resistant paint, nickel-coated clamping plates with covered threaded drillings and a laminar flow box, which supplies air with low particle content to the interior mould space.

Plastics equipment supplier Wittmann Battenfeld UK made its Expo debut in 2015 and Barry Hill, managing director, is looking forward to good things again from the 2016 show. Wittmann Battenfeld now has a range of pre-qualified med-tech injection moulding machines which were first showcased at the Fakuma plastics exhibition, Germany in October 2015.

MTI Expo 2016 has been courting the growing and successful plastics processing industry in Ireland with magazine coverage of the biennial Med In Ireland event.

Hill added: “We are looking forward to doing business with the medical moulding community at MTI Expo 2016. Too often, our customers can face a burden of testing and compliance issues regarding standards, cleanroom conditions and so forth. Our new equipment range is designed and manufactured to help the busy plastics processor by having all of that ready to go from ‘out of the box’. We are optimistic that the new machines will make an immediate impact – globally and here in the UK.” The new machine designs are built around the company’s all-electric machines to clean room conditions. For this purpose, an ISO standard class 6 cleanroom from Max Petek Reinraumtechnik, Germany was installed at the Wittmann Battenfeld plant in Kottingbrunn and the machine was thoroughly examined there. When developing the company’s moulding machines for cleanroom applications, attention was paid to optimising the interior mould space, which comes equipped with smooth surfaces, stainless steel covers and covered guide rails. The exhaust air conduits of the pneumatic valves are bundled and guided out of the cleanroom.

A number of leading Irish moulders, such as Automatic Plastics, have committed to the show and this year sees the debut of Sligo based toolmaker Avenue Mould. Led by managing director, Felim McNeela, Avenue is no stranger to companies in the UK plastics industry. It has a longstanding reputation in the sector and has scooped honours and accolades at the annual Plastics Industry Awards. Avenue joins a growing cohort of Irish based suppliers at MTI Expo including Elite Electronics Systems, based in Enniskillen. Shaun McBride, managing director at Elite said: ‘I’ve attended this event every year and it is becoming bigger and better every year. For anyone that wants to be in the medtech arena in the UK and Ireland, I would say that Med-Tech Innovation is the one for them.’ Leading medtech injection moulder Boddingtons, based near Tonbridge, Kent, is typical of the contract moulder that is thriving as a result of med-tech business. The company returns to MTI Expo with increased medtech turnover, yet another Plastics Industry Award and with high expectations for further enquiries and orders. Andy Tibbs, managing director, said: “Boddingtons had a fantastic experience at Expo 2015 last year. We attracted a very significant batch

WWW.MEDICALPLASTICSNEWS.COM

Specialist Components for Kit Manufacture

Helping engineers find

the right medical adhesive EPOXIES SILICONES

In addition to providing quality laboratory solutions to end users, Alpha Laboratories offers extensive options and customised production of plastic components for diagnostic and laboratory kit manufacturers. Pastette® - the leading name for disposable liquid transfer pipettes. Ŷ Flexible, easy-to-use and economical Ŷ Customised design service to develop pipettes, or packaging to your exact needs Ŷ Specialist designs - ideal for kits

UV/LED CURING SYSTEMS

ISO 10993-5

USP Class VI Approved

USP Class VI

Plate Seals Ŷ &DQ EH FXVWRPLVHG IRU VSHFLÀF PDQXIDFWXULQJ and packaging requirements Reagent Tubes Ŷ A wide range of screw cap microtubes and other leak-proof containers

154 Hobart St., Hackensack, NJ 07601, USA +1.201.343.8983 ∙ main�masterbond.com www.masterbond.com

UN3373 Compliant Packaging Ŷ Custom design kit manufacturing for clinical trials

INTRODUCING

NEW PRODUCTS

Foster Medibatch™ FDA Color Concentrates

Small Lot Med-Device Compliant Color Concentrates

Foster ProFlex™ SEBS

Medical Grade Thermoplastic Elastomers

Foster PureEase™

High Yield, Easy Process Thermoplastic Elastomers

Foster HLS™ TPU

Heath & Light Stabilized Thermoplastic Polyurethane

Contact Alpha Laboratories for more information or a quotation for your OEM requirements. Visit www.alphalabs.co.uk, call +44 (0)23 8048 3000 or email marketing@alphalabs.co.uk

Foster Nanomed MAX®

Ultra-Reinforced Aromatic Nylon

FOSTER CORPORATION The leader in custom polymer technology for medical devices, implants and drug delivery applications.

P 860.928.4102 info@fostercomp.com www.fostercomp.com

38 MPNs_Specialist-OEM-Requirements_Mar16.indd 1

W W W 18/03/2016 . M E D I C09:36:44 ALPLASTICSNEWS.COM

MED-TECH INNOVATION

Team spirit: Colin Martin and Andy Tibbs, managing director of Boddingtons Winning ways: Lucy Bridge, Boddingtons with the 2015 Plastics Industry Award for the Boddingtons design and moulding work involved in the Braidlock device

of interesting and solid enquiries, many of which entered into our gated product introduction process. The net result in was an increased in new business that is now a healthy part of our overall company growth.

company is too small or too big for us to do business with. Right from the outset we made a point of working with start-ups who specifically demonstrated both drive, initiative and strong intellectual property.”

Tibbs added: “Successful manufacturers today not only need to make a great product. Increasingly they need to master the arts of marketing – to see and be seen – and to clearly communicate services, strengths and benefits to target markets. Boddingtons is walking this talk as part of our ambitious growth trajectory. Expo 2016 will play an important part in helping us achieve our aims and our sales targets.’

A number of these start-ups are now beginning to produce significant sales. This includes Arc Medical, on behalf of whom Boddingtons won the Industrial Product Design of the Year Plastics Industry Award.

The past six years at Boddingtons have seen quantum leaps in growth. Company turnover has been trebled - from £5m in 2010 to £15m at the beginning of this year. Growth of 7% is forecasted for this year; and the management group is confident of meeting a £28m turnover target by the end of 2020. The company’s growing and awardwinning reputation for medical and healthcare moulding is helping fuel the expansion. This in turn has meant niche roles and recruitment – particular for specialists in financial, regulatory and quality support. Tibbs reflects on the recent period: ‘We have succeeded in attaining a new reputation in medtech and technical moulding. Most people realise that medtech business generally provides opportunity for better margins. The real benefit however, is that once established, medtech provides a much more stable and sustainable future.” So what are the secrets in winning that medtech business? “Openmindedness is key,’ said Tibbs. “No

Boddingtons also makes it easier for clients by invariably handling legal responsibilities for the products it makes. “We do this for a variety of reasons,” said Tibbs. “And it also sharpens up our own business and manufacturing practices to a very competitive level.” One physical manifestation of this growth can now be seen in building work at the Marden-based site. Plans were set in motion last year to double the size of the company’s production by building an additional facility at the rear of the current plant. Planning permission was gained in in Q1 2015 and building work commenced in Q2 2015. It is expected that the new building will be operational in stages, beginning at the end of Q2 2016. An approved investment of £4.6million has been earmarked to cover the new fit-out and additional capacity. Within the new Boddingtons facility, 50% of the space will be cleanroom manufacturing. This will provide two facilities close to each other, which offers ‘risk mitigation’ for Boddingtons customers. The additional building will, other than the cleanroom, be a large whiteroom manufacturing facility, along with a specialised assembly area. Tibbs said: “Successful manufacturers today not only need to make a great

product. Increasingly they need to master the arts of marketing – to see and be seen – and to clearly communicate services, strengths and benefits to target markets. Boddingtons is walking this walk as part of its ambitious growth trajectory. Expo 2016 will play an important part in helping us achieve our aims and our sales targets.’ Martin said: “We are delighted to have a key player such as Boddingtons showing its wares at MTI Expo once more. The company realises that our exhibition provides unique, networking, contact and opportunities for suppliers to the medtech and healthcare industries.” The MTI Expo 2015 event saw a clear increase in the number of plastics companies exhibiting. EXPO 2016 will see a further leap in their numbers. The fledgling Make It In Plastics network fielded a ‘village’ of ten companies at the show in 2015 and is returning this year, hoping to increase their number. MIIP director Adrian Lunney said: “MTI Expo 2016 is a classic opportunity for MIIP and for all SME plastics processors to get involved in marketing to this high value-added sector.” Martin added: “MTI EXPO 2016 is also seeing more businesses catering to a trend in global healthcare towards product innovation and self-medication devices. Plasticsbased designs and products have automatically been to the fore. This has meant opportunity and expansion for those manufacturers that have been able to rise to the challenge. “MTI Expo 2016 therefore encourages all in the plastics sector to come and enjoy all the various facets of our two day show.”

WWW.MEDICALPLASTICSNEWS.COM

NEC BIRMINGHAM, UK | 26-28 SEPTEMBER 2017

INJECTION MOULDING

EXTRUSION

ROTATIONAL MOULDING

BLOW MOULDING

RECYCLING

THERMOFORMING

M AT E R I A L S

VAC UUM FO RM IN G

DESIGN

FILM EXTRUSION

EXHIBIT NOW www.interplasuk.com

IN FOCUS J PAC

A WORD WITH

THE BOSS What plans do you have for J-Pac’s growth strategy this year? J-Pac Medical has been well known for its capabilities in sterile packaging for many years. Our plans are to raise market awareness for the company’s other significant capabilities. J-Pac has extensive expertise and experience in manufacturing Class III implantable textile devices that require precision forming and particulate-free cutting. J-Pac has been a pioneer in enabling point-of-care diagnostics through its lab-on-chip reagent blister technology that utilise frangible seals. The company also both manufactures and packages finished sterile devices, including dry-room processing of environmentally sensitive medical products. In all these markets, J-Pac brings a compelling value proposition based on technical competence, execution and value.

In what way will your previous experience be put to use in your new role? I have more than 25 years of experience building high-growth medical product-based companies like GI Supply, Optim, Haemonetics and Aspect Medical Systems, which was acquired by Covidien. I understand the challenges of leading a company in today’s healthcare space and know how to implement successful growth strategies while driving operational excellence. Today’s medical device market is all about value. OEMs need to deliver products that provide proven patient value – both clinically and economically. This requires that supply chain partners such as J-Pac mirror those attributes by producing the highest quality products, on-time, and at a price that enables both parties to be successful. I think J-Pac Medical is ripe for growth and brings a lot to the table in terms of what it can do for its customers. My collective experience will

serve me well in managing a high performance management team; developing and implementing optimised operating infrastructure and manufacturing processes; and improving existing product pipelines and growing new ones for J-Pac.

What new initiatives do you have planned for 2016? We are heavily investing in adding more medical device capabilities and expanding our existing manufacturing services for devices used in orthopaedics/spine, sports medicine, and cardiovascular procedures. We also plan to have a significant announcement later this year for a new and potentially ground-breaking implant. Additionally, we are touting J-Pac’s dry room processing capabilities for the packaging of environmentally-sensitive healthcare products. J-Pac’s dry room capabilities feature low humidity processing in Class 7 cleanrooms with options for both low and high volume applications. 2016 will also bring significant changes in our manufacturing systems as we continue improving efficiency, quality, and on-time delivery.

Where do you see the company this time next year? We want people to see J-Pac Medical as the go-to value added contract partner not just for their medical packaging but for virtually all of their outsourced needs. Whether they need support with implantable textiles, lab-on-chip reagents, thermoformed packaging or medical devices, we have the capabilities and expertise to support innovation from the inception of an idea through the product development all the way through the phases of the supply chain.

WWW.MEDICALPLASTICSNEWS.COM

Design, Develop & Deliver with Distrupolâ&#x20AC;&#x2122;s range of medical polymers

+44(0)1932 566033 info@distrupol.com www.distrupol.com

8464 Distrupol Advert - Medical Plastic News - Q1 2016-Final.indd 1

24/03/2016 09:33

ROBOTICS

Automatic for the people

obotic automation in the injection moulding (IM) process is no longer the preserve of pharmaceutical manufacturers with cleanroom environments. The latest statistics released by the European plastics machinery According to organisation EUROMAP, shows that the Sumitomo (SHI) number of IM machines sold equipped robots rose from just 18% in 2010 Demag faster return with to almost a third (32%) in 2015.

on investment, sterile conditions and safer production processes are thanks to the automation of precision moulding operations

Added benefits: Where high precision is required, integrating robots into moulding cells is beneficial

“There has been a significant upwards trend,” observes Nigel Flowers, managing director at IM machinery supplier Sumitomo (SHI) Demag UK. “I think part of this has been driven by demand for more flexible solutions, and the use of 6-axis industrial robots, especially in precision IM, is certainly more commonplace today.”

He adds: “In terms of robotic configurations, there is certainly plenty of choice. If all the robot is doing is moving a part from the moulding machine, a 3-axis robot should be sufficient. However, a 5 or 6-axis robot can perform more complex manipulation tasks. Precision components, such as electronic parts or hearing aids, are typically getting smaller and smaller. When you are handling In precision moulding or trying to remove parts from a mould that measure applications, robots are just millimetres, a dexterous robot is very important.”

“

“Being able to operate around the clock inevitably increases productivity and looked at for their range consequently In 2009, the Sepro Group, in partnership with of operation, accuracy, profitability,” says Sumitomo (SHI) Demag, developed a special range repeatability and Flowers. “Also, there of robots adapted to the company’s popular Systec cleanliness. is greater awareness and IntElect systems. Both systems are widely used in among users that with electronics and medical moulding. industrial robots today, you’re not just specifying for a single Noting the benefits of integrating robotics into precision application,” he points out. “Whether injection moulding systems, Glen Eves, general manager at Sepro UK, says: “In precision moulding applications, it is three months or three years, or whatever the product robots are looked at for their range of operation, accuracy, lifecycle turns out to be, a robot can be reprogrammed to repeatability and cleanliness. Sometimes the customer support a different product. We are seeing larger numbers needs to transfer parts, insert load, apply labels or remove of customers switch from Cartesian robots to industrial 6-axis systems, which is in part due to the price gap complex parts in non-linear movements.” closing but can also be attributed to technical applications Despite growth both in the number of IM machines fitted involving complex take out movements and assembly with robots and of broader acceptance of their value, operations. Additional evidence suggests that customers questions remain for many in the plastics industry. Flowers are also future-proofing their investments.” and Eves address some of those lingering doubts. Eves concurs: “Customers are increasing the specification of their robots at the time of order, rather than paying How do I know the return on investment (ROI) for costly retrofits. Typical requests run from additional adds up? stroke lengths to cover a larger working envelope for downstream automation, adding in second and even third The fact that larger numbers of smaller businesses are rotations for product orientation and additional valves for finding the capital cost of robot-equipped IM machinery extra gripping circuits. Upgrading to a robot controller also more affordable is helping to make ROI calculations easier. facilitates complex path tracking movements, enabling the Of course, these calculations will be different for every management of downstream automation from a handset business, but should take into account benefits such as and control of all the robotic equipment from a single quality improvements, repeatability and extended working screen.” hours.

WWW.MEDICALPLASTICSNEWS.COM

Robotics is a ‘black-box’ technology that we will have no control over?

What are the commercial benefits in precision moulding?

Robotic IM technology has moved on significantly, particularly in relation to adjusting settings and switching between programmes. “You no longer need to call in an absolute expert to carry out reprogramming,” states Flowers. “Control systems have evolved. Although the individual responsible for setting up and operating the machine will still require some form of training, the entire skill set is now within a customer’s own capabilities.”

“Applying robotics to precision moulding tends to be about minimising damage to parts and reducing quality costs and defects,” says Flowers. “The materials used will often be more expensive than in other sectors, so you set out to reduce waste as much as you can.” Eves adds: “The use of poly-articulated robots has seen a growth in this area as they have many of the attributes required for these precision applications. But recent years have seen the bringing together of the technologies of Cartesian robots with poly-articulated units.” Benefits include shorter interruption times in the moulding cycle and faster overall cycle times. There are also safety and accuracy benefits.

However, at a national level, there remains a pressing need to ensure that the next generation of IM technicians and engineers are equipped with the necessary skills to fill these in-house roles.

Trend Setter: Nigel Flowers, Sumitomo (SHI) Demag UK, says there has been a significant upwards trend in the use of robots

At the design stage it too is easier for customers to be directly involved in scoping out the different options with regard to layout and robot specification using sophisticated computer graphics. Flowers elaborates: “In order to minimise the number of compromises later down the line, we ideally bring the customer and all other partners together at the earliest stage of each project. The earlier decisions about robotics are taken, the better the solution.”

For a small company, is robotic automation appropriate? Although the strongest associations for sophisticated robotics are with large and already highly automated operations, such as automotive plants, robotic development is just as rife among smaller-scale manufacturers. “Even precision moulders with just three or four IM machines are seeing the benefits of being able to extend their working hours,” says Flowers. “If they want to move to longer shifts, they may be looking at the simplest solutions, such as Cartesian robots.” As those companies grow, plan for the longer-term and put more emphasis on in-built flexibility, there is always the option of moving to a 6-axis alternative.

Do I really need a vision system? There is a widespread misunderstanding that robots are inseparable from vision systems, and that vision adds another major layer of cost and complexity to the IM operation. For precision applications, vision provides quality assurance and is especially beneficial specialist sectors such as automotive components and medical devices where product dimensions and overall specifications have to be precise. “Realistically, integrating vision into the IM process will only suit specific applications,” notes Flowers. “Aside from inspection quality control and guaranteed repeatability, in precision moulding it can be beneficial for determining the orientation of products, accurately guiding the robotic arm to trim away flash, or for assembly and packing.” 44

Robots can also be used to strip sprues and waste from around the mould and placing them in a granulator for recycling, notes Flowers.

It is also important for customers to realise that the theoretical benefits of a system can be maximised and tailored to suit specific needs at the installation stage. Flowers emphasises: “Commercial advantage is not just about installing this IM machine or that robot. At Sumitomo (SHI) Demag we are focused on optimising customer investments, and continue to develop our application engineering team in order to ensure that ROI is maximised in specific environments, including precision moulding.”

Will a robot truly boost my already flexible plastics workforce? ‘Flexibility’ is an attractive idea, yet for many manufacturers in the precision moulding arena, consistent performance and consistent quality are the most important criteria. Both can be provided for by robotics. At the same time, the UK cost of labour continues to rise. “One operator can look after, say, 10 machines equipped with industrial automation,” notes Flowers. “You can achieve more consistent output while reducing manufacturing costs. Rather than being a jobs taker, there’s strong evidence that adoption of robots across all manufacturing sectors is driving the need for more advanced engineering skills.” There’s little doubt that in terms of flexibility and dexterity, integrating robotics and automation into IM precision setups can increase manufacturing competitiveness. “Plastic processors today are rarely considering the injection moulding machine in isolation,” observes Flowers. “There is a definite shift towards integrated production cells, with a need for robotics and peripheral equipment to work seamlessly together.” Until recently, much of the resistance has been tied to cost, expertise and lack of understanding on how a precision moulder could produce an attractive return on their investment. However, for moulders producing premium quality parts, robots stabilise the manufacturing process, boosting efficiency and output. Combined with lower capital costs, this makes the business case for investment in robotics stronger than ever.

WWW.MEDICALPLASTICSNEWS.COM

INJECTION MOULDING

Part of the process Cheryl Weckle and Michelle McManus, technical services & development â&#x20AC;&#x201C; medical applications, Trinseo, discuss how a process approach to moulding can lead to better results

edical moulders are continually challenged to expand their role into areas such as product design, material selection and parts and product qualification. As their function evolves, many are taking a process approach to their business. They are considering all the activity surrounding the molding process, determining who and what impacts the process, and, soliciting the involvement of the impacted parties, or stakeholders. This approach and emphasis on collaboration is crucial to driving efficiencies and ensuring a successful end result.

One of these parties is the resin supplier, the provider of the plastic used to mould the parts / components. There are two key reasons to include the resin supplier early and often in the development process: 1. For the expertise, insights and past experiences they alone can provide, and 2. To allow the resin supplier the opportunity to gather important information about the end use application and performance requirements that will help better support the OEM with resin recommendations.

Following are ways the resin supplier makes an impact:

Recommendations for product selection As commodity resins are replaced by more advanced, highperformance materials to meet the complexity of the medical device market, it is often a challenge for moulders to keep up-to-date with technology. The resin provider, who works with plastics every day, can provide recommendations on the latest innovations and preferred solutions for medical devices. Although the medical device manufacturer and moulder must decide on the appropriateness of the resin for particular applications, with an understanding of specific application requirements: product performance needs (eg durability, flame retardancy), requirements for sterilisation (eg gamma, electron beam, autoclave), and environmental exposure concerns (eg UV light, chemicals), resin suppliers can suggest material alternatives. In addition, they can evaluate and suggest whether or not products that are currently being used seem to be most appropriate, guarding against possibly using an overengineered product, which might add unneeded expense.

Alignment of processes for quality and consistency Medical devices OEMs are subject to stringent regulatory requirements relative to the devices they manufacture, and the ability to comply, is influenced by materials used in production. Aware of this, moulders need to go â&#x20AC;&#x2DC;downstreamâ&#x20AC;&#x2122; to make certain the materials supplied are aligned with production standards and requirements for the medical

WWW.MEDICALPLASTICSNEWS.COM

device market and the specific application, as determined by the OEM. Are the materials biocompatible? Are they properly certified according to ISO and USP standards? Have the materials undergone regulatory evaluations? Are processes aligned to comply? If the resin supplier is kept in the loop, from as early in the process as possible, he or she will make certain to deliver what is required: quality medical grade resins produced under stringent quality guidelines, controlled conditions and validated processes. In addition, the supplier can put processes in place to ensure a consistent, predictable, sustainable supply, which is critical in the medical industry.

Laser Plastic Welding

Documentation of regulatory compliance As part of regulatory requirements, documentation of quality assurance is needed throughout and after the life of the medical devices manufactured. As with most processes, it is easier establish a method to gather this information upfront during the manufacturing design process than to attempt to recreate a paper trail after the fact. A moulder needs to have a relationship with its resin supplier to make sure this evidence can be produced and delivered to OEMs and / or regulatory bodies, as needed, in a timely and accurate manner. Sometimes a moulder will be disconnected from its supply chain making the procurement of documentation, if it has not been anticipated, stressful and a challenge. Typical documentation for the industry needs to include Management of Change processes, ie lot traceability, formulation lock, notification of change and extended record and sample retention.

Expectations for collaboration Key point: As commodity resins are replaced by more advanced, high-performance materials it is often a challenge for moulders to keep up-to-date with technology

Involvement of the resin supplier, early in the process, clearly makes a difference. Obviously, moulders are capable of understanding the aforementioned issues but the fact is, the resin supplier, singularly focused on the materials component of the design process, is in the best position to offer input and deliver on elements that fall into this area of responsibility. To conclude, it is important to select a resin supplier that offers medical sector expertise, is familiar with the challenges of medical device OEMs, and aligns processes to customer needs and expectations. The importance of staying engaged and encouraging collaboration with the moulder and others in the production cycle to maximise efficiencies and ensure success is paramount.

Reliable, Clean, Economic LPKFâ&#x20AC;&#x2122;s production solutions â&#x20AC;&#x201C; success through experience.

MEDTEC Europe: April 12 â&#x20AC;&#x201C; 14, 2016, Stuttgart, Hall 7, Booth C11

The timely and accurate flow of information is essential to the development of successful medical applications. The original equipment manufacturer (OEM) drives the process by sharing information with the moulder, designer and resin supplier, who provide potential alternatives based on compliancy requirements

WWW.MEDICALPLASTICSNEWS.COM

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

28 SEPT - 29 SEPT 2016

EXHIBIT NOW

ELASTOMERS

Wear it well: Surgeons in the operating theatre need to be able to concentrate for hours, so they want a gown that is comfortable to wear, says Rainer Meburger, DSM

Dressed for success T

he importance of gowns for medical staff and patients cannot be overestimated. These garments offer the first line of defence against bacterial and viral infections.

DSM explains how its elastomer is being put to use in medical gowns to protect against hospital-acquired infections

And the data about so-called hospital-acquired infections, or HAIs, is truly staggering. Research shows that 1 in 10 hospitalised patients will acquire an infection after admission. The US Centers for Disease Control & Prevention (CDC), for example, stated recently that there were an estimated 722,000 HAIs in US acute-care hospitals in 2011 (the most recent year for which data are available). About 75,000 hospital patients with HAIs died during their hospitalisations. And more than half of all HAIs occurred outside of the intensive care unit.

Similarly, the European Centre for Disease Prevention and Control reported an average prevalence of 7.1% of HAIs in European countries and estimated that more than 4.1 million patients are affected every year in Europe. In short, hospital-acquired infections put patients and hospital staff at risk and cause major additional healthcare expenditures. That’s why infection control is a key topic. Hospital administrators increasingly appreciate just how important medical clothing can be in preventing infection. Surgical gowns can offer important protection – provided they have the necessary barrier properties. Netherlands-based Royal DSM, a global science-based company focused on health, nutrition and materials, says there’s a good reason that use of medical gowns made with membranes from its Arnitel VT thermoplastic copolyester elastomer is long-established and yet continues to grow. Gowns made with this material have been used successfully in leading US hospitals and medical installations for nearly a decade. Arnitel VT, which DSM produces in the Netherlands, is a very flexible material that, when made into membranes down to a few microns thick, is 100% waterproof but also highly breathable, comfortable and durable. These membranes contain no perforations, but still allow the passage of moisture vapour.

The waterproof performance of perforated membranes is more likely to be compromised during washing or when in contact with liquids such as disinfectants, or with bodily fluids, alcohol or fuel. Perforations also reduce the strength of the membrane, increasing the chances of ripping. And such tiny holes can become clogged, causing the membrane to lose much of its breathability. Since Arnitel VT is not perforated, it acts as a barrier to not only liquids, but to bacteria and viruses as well. Depending on the performance level of a gown, different levels of barriers are needed. “Bacterial and viral barrier under wet conditions is the most severe circumstance for a membrane,” according to Rainer Meburger, DSM’s global business director for Arnitel. Comfort also plays an important part in material choice. “Surgeons in the operating theatre need to be able to concentrate for hours, so they want a gown that is comfortable to wear,” said Meburger. “Comfort is related to several aspects – design, fit, breathability, weight and skin sensitivity. Arnitel VT is particularly strong in most of these aspects.” Medical gowns made from Arnitel VT are designed for singleuse, in line with trends around the world. Roughly 60% of the European market for surgical gowns today is disposable, while in the US the figure is above 90%. The percentage of singleuse surgical gowns is lower in other regions, but continues to increase. Meburger points out that, in addition to all these performance characteristics, Arnitel VT also has a strong sustainability story. It is fully recyclable, and the material also is completely free of perfluorinated compounds. Arnitel VT membranes are manufactured from a lowercarbon-footprint polymer and use less material than standard membranes based on PFCs, such as polytetrafluoroethylene (PTFE). If everyone in the global breathable membrane market (estimated at 25 million square meters per year) would use Arnitel VT, DSM suggests that carbon dioxide emissions could be reduced by some 5.2 kilotons. That is equal to the average annual carbon footprint of 650 people in Western Europe, or to travelling around the world in a car 990 times. “Arnitel provides the combination of comfort – feel and breathability – as well as a 100% bacterial and viral barrier,” Meburger claims. The stakes are too high, he suggests, to compromise on other materials that don’t offer all of these key features.

WWW.MEDICALPLASTICSNEWS.COM

anything that may cause the newborn’s body temperature to drop. Neohelp creates a protective microclimate and acts as an effective barrier against heat loss.

BEADY

eye

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

Who are you and what do you do?

Stéphane Regnault, chairman of Vygon’s board of management explains the company’s role in the single use medical devices sector

Vygon designs, manufactures and markets high-tech single-use medical devices for healthcare professionals in hospitals and for use by private or independent practitioners. The company offers a range of products in a number of clinical specialties including: neonatology, adult and paediatric critical care, anaesthesia,oncology, emergency, surgery and home care.

SINGLED out

Our key products include Bionector – a closed needleless connector, Leadercath – venous and arterial catheters, Nutrisafe 2 - the first safety enteral nutrition range for newborns and children and CPAP Boussignac – a noninvasive ventilation device. With expertise right along the value chain, from product design to the delivery of training for medical personnel, Vygon offers health professionals the most efficient and innovative medical products available.

What projects have you been focused on recently?

Vygon is currently investing in Asia and South America through its subsidiaries and local partnerships.

cardiovascular medical devices and long-term vascular access devices. This strategic acquisition has reinforced Vygon’s existing product range and strengthened its position in the adult long-term vascular access market, estimated to be worth €1.1 billion (£848 million). In 2014 Vygon expanded its range of enteral nutrition products for hospital and home use with the acquisition of Medwin. Medwin is a company based in southern France, and specialises in enteral nutrition (feeding pumps) and related accessories. Enteral nutrition is an artificial feeding technique that replaces standard meals with liquid food for individuals who can no longer feed themselves by mouth, but whose digestive system continues to function. Worldwide sales of oral and enteral nutrition products totalled nearly €6.6 billion (£5 billion) in 2011 .

Describe your latest innovation?

Neohelp is the first device with CE marking designed specifically to prevent hypothermia in newborns. The product was developed in partnership with two health care professionals from the National University Hospital (Rigshospitalet), Denmark. The double layered plastic pouch can be adjusted to fit the newborn infant and offers protection from

In September 2015, Vygon opened a subsidiary in Turkey’s administrative and academic capital, Ankara. This is the group’s first in the Middle East region. Its purpose is to promote and market Vygon’s medical devices through communication and training initiatives. With a population of 80million, the country’s spending on healthcare has increased significantly in recent years; rising to nearly 7% of GDP in 2010. Another focus has been on strategic acquisitions. In July 2015 Vygon acquired Perouse Medical. Perouse Medical is a French company that designs, manufactures and markets

WWW.MEDICALPLASTICSNEWS.COM

Neohelp is designed to improve observation, stabilisation, handling and resuscitation of the infant during the first vital minutes of life without the infant being exposed to a cold environment. The device is easy to use and suitable for every setting where birth may take place – delivery room, operating room, intensive care unit, emergency room, at home or in an ambulance during transportation.

What does it mean for the medical sector?

The product was developed in response to an unmet medical need for prevention of life threatening hypothermia in our most vulnerable patients – the sick, newborn and preterm infant. Hypothermia affects newborn babies worldwide. It is present in all climates and can occur regardless of the weight and gestational age of the newborn. Hypothermia is one of the main risk factors for morbidity and mortality in the newborn population. Thermal balance is essential for cardiorespiratory development in newborn babies. A baby’s body temperature can drop by at least 2-4°C during the first 10-20 minutes of life. For every 1°C fall in temperature, the risk of mortality increases by 28%. Premature babies are even more susceptible to hypothermia; in fact more than 56% of premature babies weighing less than 750g have significant hypothermia upon admission to the neonatal intensive care unit. The urgent imperative to warm up consumes all available energy resources of the newborn in just a few moments, sometimes with serious longterm consequences, particularly in premature babies.

Plans for the future?

Vygon plans to launch new gamechanging products every three years, in highly specialised clinical fields, such as oncology (protecting medical staff from drugs contamination), emergency (treating cardiac arrest faster and better) and adult intensive care (controlling beat by beat cardiac output).

Idea. Prototype. Done.

Visit us at Med-Tech Stand 46

(Itâ&#x20AC;&#x2122;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 Abbigail Titmus Customer Service Representative

Order online anytime | Free design analysis

protolabs.co.uk +44 (0) 1952 683047 customerservice@protolabs.co.uk