MPN EU Issue 45 by MPN Magazine

EUROPEAN EDITION

MEDICAL PLASTICS news FR

ST M A T

O U W T D

IN M SP JEC PAM O TI TL O ED IG N M IN HT O FO O UL CU N M DIN S AT G ER IA LS

The best of the medical plastics world unveiled ISSUE 45

Nov-Dec 2018

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Medical Solutions

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CONTENTS Nov-Dec 2018, Issue 45

Regulars

Features

5 Comment Lu Rahman gives her opinion on the industry

27 How to get the best out of Compamed 2018 By Dave Gray

41 Playing it safe Cikautxo offers expertise for antithrombogenic catheters

7 News analysis Callum Little examines the ongoing BPA debate

31 Making the connection Phillips-Medisize on the trends driving growth in connected health solutions

45 East meets West US contract manufacturer produces high precision silicone components in China

33 Bioabsorbable polymer mesh gets FDA seal of approval

53 Seeking approval Knoell Germany examines the challenges for start-ups gaining approval

8 Digital spy 18 Cover story The best of the medical device supply chain 54 12:2018

35 Resistance training Eastman, Ultrapolymers and Francesco Franceschetti Elastomeri detail innovative materials

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When blood is flowing outside of veins, hopefully it’s flowing through CYROLITE. Our high-performance medical acrylics are chemically resistant to lipids, are BPA- and DEHP-free, and can be reliably sterilized using gamma irradiation, e-beam irradiation, and ethylene oxide. This has impressed both vampires and health-care professionals alike: CYROLITE meets the requirements of USP Class VI, ISO 10993-1, and REACH. You can learn even more about our blood-friendly multipolymers at www.cyrolite.com.

CREDITS editor | callum little

I continually find it frustrating to see some products some companies push our way and claim has a valid medical purpose.

EDITOR’S

comment

head of content | lu rahman deputy group editor | dave gray reporter | reece armstrong advertising | gaurav avasthi head of media sales life sciences & plastics | lisa montgomery head of studio & production | sam hamlyn graphic design | matt clarke publisher | duncan wood Medical Plastics News is available on free subscription to readers qualifying under the publisher’s terms of control. Those outside the criteria may subscribe at the following annual rates: UK and Europe: FREE North America: £249 Rest of the world: £249 subscription enquiries to subscriptions@rapidnews.com Medical Plastics News is published by: Rapid Life Sciences Ltd, Carlton House, Sandpiper Way, Chester Business Park, Chester, CH4 9QE T: +44(0)1244 680222 F: +44(0)1244 671074 © 2018 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.

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

Why the digital health market isn’t going anywhere

nyone in the industry who has been following the launch and reporting of the Apple Watch will no doubt have come across the debate over whether the product is or isn’t a medical device. It’s interesting, not just because this latest watch seems to be a way for Apple to make a serious attempt to enter the device market, but because from my point of view – and Apple Watch aside – I continually find it frustrating to see some products some companies push our way and claim has a valid medical purpose. This week for instance I was presented with a home-use product designed to help women overcome the fear they may have of doctors in white coats. I’m saying no more… The supply chain serving the medical device sector is full of innovation. From one issue of MPN to the next, we see advancing materials and manufacturing processes all with one aim – to improve efficiency of production, as well as the saleability of the finished product, which ultimately has a positive effect on health and wellbeing. Health is big business so it’s hardly surprising then that big players like Apple want to get in on the action. The healthtech market has huge global potential – industry statistics estimate that by 2020 it could be worth $206 billion dollars. At this time of year, when all eyes are on Compamed and Medica in Dusseldorf, it isn’t hard to see why.

This event alone showcases some of the best products and devices the industry has to offer. Not only does it provide the perfect forum for suppliers and OEMs to discuss the best of what is and will be on offer for the healthcare market, but the event allows us to see where it’s heading. It’s clear that the incorporation of technology, of smart and digital systems, is still high on the agenda. You only have to look at new break-out sectors such as femtech, to see how useful and valuable healthtech has become to this element of the population. But of course it doesn’t stop there which is why companies such as Apple are incorporating high-tech health elements into new releases. And why not? The digital health market isn’t fading – by 2020 it’s reported it could hit the $200 billion mark. Any forward-thinking business worth its salt with a foot in this door will of course want its share of this. As the average person becomes increasingly interested in buying in to their longterm health prospects; as healthcare professionals seek better and more efficient ways of treating patients, and as global healthcare networks want innovative devices that provide value for money and improve diagnosis, treatment and prognosis, why wouldn’t companies like Apple want to be part of that? Medical device or not, any product that helps us question our health, improve the way we think about what we consume, burn-off and monitor, surely has to be a good thing?

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Visit Qosina November 12-15, 2018 at Compamed - Stand 8AL16, Messe Düsseldorf, Düsseldorf, Germany. Qosina is a leading global supplier of thousands of OEM single-use components to the medical and pharmaceutical industries. Log on to qosina.com to see our full product offering.

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Is BPA now safe to use? CALLUM LITTLE EXAMINES THE ON-GOING BPA DEBATE. WITH A REPORT LANDING FROM THE NATIONAL TOXICOLOGY PROGRAM, HE ASKS WHEN WILL WE SEE THE END OF THE BPA DEBATE?

he safety of bisphenol A (BPA) has been a contentious topic in recent years with numerous studies and research projects taking place to try and definitively answer whether there is a health risk to humans associated with the chemical. BPA is used in the production of certain plastics such as polycarbonates and epoxy resins, which are often used to make food packaging. It is also used in the production of polymers for medical devices such as catheters and implants, and some dental devices. There was hope of a definitive answer to the safety of BPA after the establishment of the Consortium Linking Academic and Regulatory Insights on Bisphenol A Toxicity (CLARITY-BPA) – a research collaboration established by the National Institute of Environmental Health Sciences (NIEHS) and the Federal Drug Administration (FDA). CLARITY-BPA had two components: A Core Study that was conducted in-house by the FDA, would test the potential of BPA toxicity in pregnant rats. There was a second component of Grantee Studies that would be conducted by researchers at academic institutions, to carry out testing using animals raised in the same conditions and exposed to the same doses of BPA as the Core Study. Despite the recent publication of the results from the Core Study suggesting that there were a number of statistically significant endpoints, the NIEHS released a statement that played down the results on a basis that the BPA doses some rats were administered were overtly-high. The Institute said: “These exposure levels were many times higher than people typically receive” and that when rats had health effects at lower doses, the authority was, “uncertain whether the changes were related to BPA exposures.” John Butcher, NTP senior scientist said: “To fully understand the Core Study results, we need to compare these traditional guideline studies with results from the Grantee Studies, which looked at a broader range of health conditions. This will be done in the final integrated report next year.” The results of the CLARITY-BPA guideline study, conducted by the FDA were published in a draft report by the National Toxicology Program (NTP) in February 2018. Dr. Stephen Ostroff, deputy commissioner for foods and medicine, FDA, proclaimed: “Our initial review supports our determination that currently authorised uses of BPA continue to be safe for consumers. The report also

builds upon the already extensive data collected in the FDA’s 2014 assessment of the safety of BPA.” The FDA was criticised by some CLARITY grantees and scientific groups such as the Endocrine Society, after issuing this statement regarding the pre-peer reviewed results from the Core Study. The agency originally promised to refrain from drawing any conclusions until the full results of the CLARITY-BPA study were published. The agency stated after reading the report that BPA posed no adverse health risk to humans. Now that the peer-reviewed study report has been released, some research institutes are stating that the FDA’s continued assertion that BPA is safe for human consumption is now contrary to the evidence available to agency. In a webinar organized by Carnegie Mellon University’s Institute for Green Science (IGS) and Environmental Health Sciences (EHS), a group of leading BPA researchers disagreed with the FDA’s dismissal of research findings that showed low levels of BPA exposure resulted in ill-health effects. BPA IN MEDICAL DEVICES The safety of using BPA in medical devices was raised by the European Commission, and subsequently referred to the European Commission Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) in 2015. Comprised of independent scientists and experts who serve as members of a working group, SCENIHR issued the following statement in the committee’s report on ‘The safety of the use of BPA in medical devices’: “Although the benefit of medical devices has also to be considered, the SCENIHR recommends that, where practicable, medical devices that do not leach BPA should be used. The possibility of replacing BPA in these products should be considered against their efficiency in the treatment, as well as the toxicological profile of the alternative materials.” The CLARITY-BPA study is ongoing and a report integrating findings from the Core Study and Grantee Studies is expected in Autumn 2019.

http://ec.europa.eu/health/scientific_committees/emerging/docs/ scenihr_o_040.pdf https://ec.europa.eu/health/scientific_committees/docs/citizens_bpa_en.pdf https://ntp.niehs.nih.gov/results/areas/bpa/index.html#core-study https://ntp.niehs.nih.gov/ntp/about_ntp/rrprp/2018/april/rr09peerdraft.pdf https://www.cmu.edu/igs/sustainable/CLARITY-BPA/index.html https://www.cmu.edu/mcs/news-events/2018/0914_CLARITY-BPA-Panel.html

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DIGITAL SPY

DIGITAL WINNER

DIGITAL

www.covestro.us

spy

WINNING WAYS:

COVESTRO PICKS UP 3M SUPPLIER AWARD TECHNOLOGY UPDATE

www.oxehealth.com Vital signs: Oxford Uni spin-off secures world first accreditation for device Oxehealth has gained European medical device certification for software enabling a digital video camera to remotely detect pulse and breathing rate. This has the potential to transform care for elderly and vulnerable people in rooms where staff cannot always be present. The British Standards Institute (BSI) has accredited Oxehealth’s vital signs measurement software as a Class IIa medical device in Europe. This is the first time that software enabling a digital video camera sensor to remotely measure vital signs has been approved as a medical device, says Oxehealth. No global medical device regulator, including the US Food and Drug Administration, has previously approved a device of this nature. To detect pulse rate, the device works in the same way as the familiar pulse oximeter, which detects the slight changes in skin colour caused by the blood being pumped around the body. However, unlike a pulse oximeter, which must be attached to a patient’s skin, it can be used to monitor pulse rate remotely. The

device also detects the movements of the body caused by breathing to count breathing rate. The Oxehealth vital signs measurement software will now be marketed alongside the company’s existing suite of contact-free activity tracking tools, which are already being used by NHS trusts and care homes to assist staff who need to monitor patients at risk of falls, self-harm or other injuries. Chief executive Hugh LloydJukes said: “I am thrilled by the European medical device accreditation, which confirms that our technology can take spot measurements of pulse rate and breathing rate that are as accurate and safe as a device that you clip on the skin. “Pulse oximeters are used in GP practices and hospitals every day. The difference is that we measure pulse rate and breathing rate entirely contact free, anywhere in the patient’s room. “This will be hugely beneficial to public and private sector organisations that care for elderly and vulnerable people, whose staff cannot be present in every room or do not wish to interrupt the rest of the people they are looking after.”

‘

Covestro, has scooped a 2018 3M Supplier of the Year Award. Only 16 of 3M’s 100,000 suppliers earned this recognition, and Covestro was the only polymer company to make the cut. Covestro and 3M have a relationship that has spanned decades. Covestro›s raw materials for coatings and adhesives can be found in a range of 3M’s polyurethane coating and adhesive applications. Suppliers singled out by 3M were recognised for embracing compliance, ethics, safety, sustainability and world-class operations, as well as a focus on customers, growth and innovation. According to Bruce Benda, head of healthcare commercial operations – polycarbonates Americas, Covestro, the company was commended for its efforts to ensure the reliable supply of raw materials despite challenging conditions, including a tight market and Hurricane Harvey, which affected Covestro’s Baytown and Channelview, Texas operations. In presenting the award

to Covestro, 3M also recognised the importance of local key account managers Lanette Brennan (polycarbonates business unit) and James Kim (coatings, adhesives and specialties business unit). “3M is considered one of the most-innovative and recognisable companies in the world, and we’re privileged to be able to continue to grow our business and collaborative relationship with them,” said Benda. “So many people across the global Covestro organisation should be thanked for what they do every day to support 3M. We proudly share this recognition with them,” he continued.

MATERIAL UPDATE www.SolvayHealthcareNews.com

ALTERNATIVE THINKING:

SOLVAY RESIN TAKES PLACE OF STAINLESS STEEL Solvay has revealed that Innovative Surgical Designs, a developer and manufacturer of orthopaedic spinal systems, has chosen Ixef polyarylamide (PARA) resin to innovate a new single-use surgical instrument kit for minimally invasive spinal fusion surgery. Innovative Surgical Designs’ new Redi-Spin kit utilises Ixef PARA’s mechanical strength, mouldability and gamma sterilisability to offer an economical alternative to reusable stainless steel instruments, says Solvay. “Ixef PARA’s metal-like strength and rigidity enabled us to simplify and

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deliver Redi-Spine instruments in a compact, elegant kit,” explained Jon Rinehart, chief financial officer of Innovative Surgical Designs. “When we first started heading down the path of polymer instruments, I candidly admit that I was skeptical. I didn’t think an injection-moulded alternative to stainless steel was possible. But when we started working with Solvay’s Ixef PARA resin, I realized how wrong I was. We wouldn’t be able to offer the Redi-Spine kit for all of our surgeons’ one- and two-level cases without Solvay’s high-performance polymer and application support.”

DIGITAL SPY

NEW LAUNCH

fast workers: New device launches from Freudenberg Medical aim to accelerate time to market www.freudenbergmedical.com Freudenberg Medical has announced several new options for medical device companies looking to accelerate time to market. The Composer XL Deﬂectable Catheter Handle Platform offers a commercialization-ready interface to provide integrated control and has been sized for large bore structural heart and endovascular devices such as transcatheter tricuspid and mitral valve delivery systems. Meanwhile, the HyperSeal XL, is a new member to the hemostasis valve family, designed to provide a robust design option for vascular access applications up to 30Fr and 40Fr. Also making their debut this year’s are the 8.5F and 12Fr Composer Steerable Introducers, new finished device solutions for private label development and customization for a range of electrophysiology, structural heart and vascular applications. “Freudenberg Medical’s new ComposerXL and HyperSeal XL were developed to address the unique challenges with large bore vascular access and device delivery in the

POINT

rapidly evolving transcatheter valve and endovascular space. The significantly larger size of these emerging therapeutic devices are demanding innovative and unconventional solutions to reduce risk and improve outcomes,” said Bernie Kaeferlein, director of portfolio management at Freudenberg Medical. “As a partner for innovation, we are committed to proactively addressing unmet clinical needs and offering our medical device customers a growing portfolio of finished device, design, and process solutions to help improve efficiency and accelerate their time to market.“

Moving Story Implant helps paralysed people walk again Is it true that an electrical implant has helped paralysed people to walk again? Yes, a small group of patients has had a device implanted that electrically stimulates their spinal cord. According to the BBC in the UK, the device, “which is placed below the injury, helps lost signals from the brain reach leg muscles”.

MANUFACTURING UPDATE

PLASTIQUE BOASTS NEW CLEANROOM FOR MEDICAL MANUFACTURE www.plastique.eu To expand its reach in the medical sector, Plastique, which was acquired by ESCO’s Thermoform Engineered Quality (TEQ) subsidiary, in 2016, has installed an ISO Class 7 cleanroom at its Nottingham facility to manufacture precision-made custom thermoformed medical packaging for pharmaceutical manufacturers’ most rigorous packaging requirements. The new cleanroom facility is certified to ISO 13485:2016 and manufactures custom thermoformed handling trays

talking

suitable for high-speed production with automated assembly and transit. Handling tray solutions include autoinjectors, dry powder inhalers, Injection moulded components, prefilled syringes, pharmaceutical bottles and medical electronics. Other medical packaging solutions available include trays, procedure sets, clamshells, tubs, skin pack sets, covers, lids, sterile barrier blisters and seal blisters.

Where has the technology been developed? The breakthrough has come out of work carried out by the University of Louisville and the Mayo Clinic. One of the participants, Kelly Thomas, 23, has experienced positive results from the treatment, as well as extensive rehabilitation therapy. She said: “Being a participant in this study well and truly changed my life, as it has provided me with a hope that I didn’t think was possible after my car accident. “The first day I took steps on my own was an emotional milestone in my recovery that I’ll never forget, as one minute I was walking with the trainers’ assistance and while they stopped, I continued walking on my own. It’s amazing what the human body can accomplish with the help from research and technology.” How exactly does it work? This research is based on two distinct treatments: Epidural stimulation of the spinal cord and locomotor training. Epidural stimulation is the application of continuous electrical current at varying frequencies and intensities to specific locations on the lumbosacral spinal cord. This location corresponds to the dense neural networks that largely control movement of the hips, knees, ankles and toes. Locomotor training aims to ultimately retrain the spinal cord to ‘remember’ the pattern of walking by repetitively practicing standing and stepping. In a locomotor training therapy session, the participant’s body weight is supported in a harness while specially trained staff move his or her legs to simulate walking while on a treadmill. 9

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THE BEST WAY

TO MEET NEW ISO GUIDELINES PAUL FLETCHER-DYER, PROCORRE, SHARES A SIX-STEP GUIDE TOWARDS MEETING THE CHALLENGE OF ISO13485:2016 COMPLIANCE

or the first time in six years the medical devices and in-vitro diagnostic (IVD) industries are facing a significant regulatory challenge, so much so the 2018 Emergo study results alluded to the effect this was having on manufacturers preparing to meet the new and strict requirements. The main regulatory challenge comes from the stronger emphasis on quality and safety through more robust quality management systems (QMS). This is in response to the well documented need for a global and holistic platform for quality systems as well as a stronger risk-based approach for manufacturers.

Therefore, manufacturers are having to balance the desire for growth and bringing new products to market with not being held back by compliance concerns or issues. The new ISO13485:2016 revision places a greater emphasis on a risk-based approach throughout the whole internal QMS, extending throughout the whole supply chain and product life-cycle; including more robust controls on device usability, clinical evaluation, and post-market surveillance requirements. Getting potentially hundreds of products compliant within the given timescale is a significant challenge for any manufacturer and each one is preparing for the new regulations in different ways. Some have invested in employing a QA/RA (Quality Assurance/Regulatory Affairs) specialist to run and oversee the whole process, however, for smaller businesses this is a costly option. Others are investing in QMS software and technical file templates with initial training, but this only covers about three quarters of the work needed as a specialist is still required to conduct a gap analysis/pre-assessment and provide a report on the items audited. Many manufacturers are also working with fixed-term subcontractors to carry out a complete audit to certification service, which is often the most cost-effective solution.

The consequences of noncompliance are catastrophic for manufacturers, and time is now running out. Any medical device or IVD that does not comply with the new ISO13485:2016 standard within the transitional time frame (March 2019), or with the medical device and IVD Regulations (ie three years for a medical device and five years for an IVD), will be refused access to key markets. Obviously, this will have huge implications for device manufacturers and second tier suppliers/original equipment manufacturers (OEMs). Medical device and IVD manufacturers who do not comply with the new ISO and medical device/IVD standard/regulations, cannot operate lawfully. However, despite these regulatory barriers and concerns, the industry is still growing rapidly thanks to major technological advances, especially in Europe which is classed as the world’s secondlargest market.

Outlined below are six steps manufacturers should take to ensure each product is compliant. By terming each as a ‘step’ this isn’t suggesting that they aren’t complex or time consuming, but more a methodical and sound approach to help take the sting out of compliance and ensure all aspects have been thoroughly thought through. STEP ONE - Carry out an initial gap analysis to challenge the life-cycle of each product. This should take between two to three full days to complete.

STEP TWO - Thoroughly review the gap analysis report to identify any or all major and minor nonconformances. STEP THREE - Produce a complete project plan driven by the gap analysis and based upon the business’ preferred timeline, to get fully compliant QMS and technical files in place. This could be in the form of a Gantt chart. STEP FOUR - Develop the QMS and technical files and then deliver the project. Depending on the size of the business, classification level and number of products being audited this should take approximately 10 to 15 days of consultancy support, if external advice is being sought. STEP FIVE - Roll out the processes with internal staff (i.e. implementation phase) and introduce an independent lead auditor to do a pre-assessment and identify any corrective action needed. STEP SIX - Hire a third-party auditing organisation (i.e. a Notified Body such as SGS, Lloyds, BSI etc.) to perform a certification assessment. Upon successful completion, the new ISO13485:2016 certification and CE Mark approval certification will be granted. The above steps will certainly help to aid compliance; however, manufacturers should be mindful the QMS needs to be continually updated and processes put in place to manage any potential complaints or report any adverse incidents. Manufacturers should also be aware of the time factors involved in implementing the changes, for example it could take months to fully upgrade the QMS and technical construction files. Being as prepared as you can be as soon as possible gives manufacturers the best opportunity to stay ahead of compliance and ahead of their competitors.

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MEDICA 2018

WHAT’S ON OFFER FROM THE ABHI AS ALWAYS, THE EVENT OFFERS SOMETHING FOR ALL ELEMENTS OF THE SUPPLY CHAIN

ust one week after his appointment to the role of secretary of state for health and social care this July, Matt Hancock took centre stage, unveiling plans to digitalise the UK’s hospitals. As part of the £487m announcement, his message was clear: “tech transformation is coming”.

MATT HANCOCK, SECRETARY OF STATE FOR HEALTH AND SOCIAL CARE, HAS UNVEILED PLANS TO DIGITALISE THE UK’S HOSPITALS

His comments were not in isolation either. The direction of travel seems to be just that: If we are to truly bring the health service into the 21st century, technology will be the answer. And the UK’s healthtech industry is well positioned to enable this vision. The UK has long been a leader in this field. World class universities, dynamic companies and the biggest single-payer health system on the planet, all add up to what is an incredible ecosystem of innovation and medical excellence. It is why overseas companies want to enter the market and it is the reason the UK carries significant weight when it comes to exploring international markets. It is, in short, a stamp of quality. With 97,000 people working in the UK’s healthtech sector, it is the life science’s biggest employer, and its importance has rightfully been recognised by the government, forming a key component of the industrial strategy. The agreement will see a transformative, multibillion-pound sector deal, ensuring that the UK remains at the forefront of innovation in this section. The implementation of which, will look to deliver the next generation of health and wealth for the UK. With such activity set to bolster what is already an incredibly strong industry, companies are now looking for the right trading opportunities to export their technologies and develop new

business. And what better place to showcase the best of UK healthtech than at the world’s largest medical trade fair, Medica. The show, which attracts over 5,000 exhibitors from 70 countries, plays host to tens of thousands of visitors every year. It is a prime opportunity to meet customers, develop relationships and forge new business. ABHI, the healthtech trade association, is once again, leading the UK Pavilion. A range of devices, software, implants, diagnostics, and everything in between, will be on display at Medica this November. Far from simply showcasing solutions, the show also provides the opportunity to wave the ﬂag for British innovation. COMPANIES EXHIBITING THIS YEAR INCLUDE: IMI Precision Engineering, which has unveiled a range of products that it will be showcasing throughout the four-day event, including BIMBA Acro product lines and the brand-new IMI FAS Microsol MS-E solenoid valve. The company will be displaying products such as miniature solenoid valves, rotary valves, pinch valves, syringe pumps, manifolds and subassemblies, all of which have been designed to meet the demanding performance requirements of medical device and diagnostic instrumentation applications. Established in 1976 and regarded as pioneers in the breath analysis market, Bedfont will be showcasing medical devices. Its carbon monoxide (CO) monitors include the Smokerlyzer, used for smoking cessation, and the ToxCO, used by emergency services to mass screen for CO poisoning. The Gastrolyzer range of portable hydrogen and methane monitors aids in the detection of gastrointestinal disorders and food intolerances.

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Surgical Use Surgical is a UK surgical instrument specialist that offers disposable solutions. It will be at the exhibition to raise awareness of their Pulse Lavage kit and the Spackman Cannula. Based in Cardiff, the disposable surgical instrument specialist prides itself on identifying difficult-to-clean surgical equipment and offering high quality, alternative single use solutions.

Export manager, Michael Denver, said: “We are always looking to expand our partner database and are keen to speak to interested partners at Medica 2018. We are fully committed to delivering high quality products, reliability and consist customer service with dedicated product support that global partners, both new and old, require to serve and nurture their markets.” Snowden will be attending to present its Babystart fertility range while Speed Plastics, a specialist in high frequency welding, will once again be at the evevent to showcase the bespoke engineering services it offers healthcare companies. The copmany offers a complete design and development service from concept idea through to the finished commercial product. Expert engineers transform ideas into commercial products that are ready for sale.

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With 97,000 people working in the UK’s healthtech sector, it is the life science’s biggest employer

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Can the government’s Brexit plans KILL OFF BRITISH LIFE SCIENCES

…ASKS DAMON CULBERT, IMMIGRATION ADVICE SERVICE The Confederation of British Industry’s latest report on Brexit claims: ‘science is borderless’. Following the recent collapse of negotiations between the UK and the EU, it seems that borders are already rising, threatening to coax Britain into a state of selfdestruction. As we are set to leave in less than six months, the government has assured citizens that freedom of movement will end in March 2019. The government cannot, however, assure anybody about anything else in the country’s future. In the British life sciences industry, EU membership has brought many great things, so what do we have to lose if Brexit brings everything crashing down around us? SKILLS SHORTAGE European workers fill positions at every skill level in life sciences. These include low-paid, nongraduate lab workers to lecturers and neurophysiologists. Yet, there are still talent shortages which even the current immigration system cannot fulfil. For non-EU migrants looking to work in British life sciences, there are many positions which are listed on the government’s Shortage Occupation List. Roles on this list include prosthetists, cardiac physiologists and diagnostic radiographers. Applicants for Tier 2 Work Visas for roles on this list enjoy less restrictions on their visa applications and even cheaper application fees. Even with full access to the European talent pool – and in

spite of the fact that the Tier 2 Visa system is often full to bursting, with the cap on visas granted being met every month except one this year – candidates are still few and far between. Should the government choose to extend the same Tier 2 system, with its limited yearly cap of 20,700, we could see rising shortages across the sector. For lower-skilled workers, the extension of the Tier 2 system is not good news. Any workers without a degree who earn less than £30,000 will not qualify under the current rules. While this affects lab workers, it also affects factory workers who package and delivery technology and medicines. The Migration Advisory Committee also recently released its report on Brexit which asserted that there would be no need to devise an entry route for lower skilled workers after Brexit. This came as welcome news to the government but will come as a serious blow to many industry professionals who know all too well the enormous contribution EU citizens make on our economy. DOVER TROUBLES Earlier this year, the government began releasing its plans for a nodeal Brexit. Among these was a provision to continue accepting EU goods with no further checks at the border until a more concrete, workable policy can be put into place. Should this happen, the government hopes that trade immediately after Brexit day should work just fine. However, if all does not go to plan, or there is no mutual acceptance by the EU

that this will go both ways, many of our day-to-day operations could come to a pronounced halt along the south coast. With no deal, UK driving licences will no longer be recognised on the continent and our goods may no longer be waved in as we intend them to. For urgent shipments of medicine or medical technology, this could come at the cost of people’s health. In addition, the future relationship will need to be agreed sooner rather than later, or the regulatory alignments between us and the bloc will soon begin to slip. As can be seen in the introduction of both MDR and IVDR which are set to come into play soon, the regulation of European medtech could quickly move far away from our own regulations. This could lead to more border complications as complex new agreements will need to be put in place before trade can be undertaken, negatively affecting our economy and the state of our healthcare innovations. With the government’s official Brexit position seemingly in tatters, a no-deal Brexit seems all the more plausible. The life sciences industry could stand to lose greatly from exiting the wider European science community. For an industry dependent on information sharing, this would be a casualty that we could feel the effects of throughout our daily lives. The government will need to come up with a new plan which ensures that life sciences will be able to function as it is so that it can continue to advance.

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COVER STORY

COMING CLEAN FR

Headed up by Michael van der Jagt, Parx Plastics is pushing the boundaries with antimicrobial technology

ST M A T

ne of my favourite developments in the antimicrobial field came via Parx Plastics. Headed up by Michael van der Jagt, the company is pushing the boundaries with antimicrobial technology. Derived from biomimicry and inspired by nature, its developments may have particular importance in orthopaedic procedures.

The company’s patented biocompatible technology is copied from, or inspired by, nature. The technology creates an intrinsic immune system in plastics that makes the surface resistant to biofilm formation and bacteria growth.

With a focus on infection prevention it is also wise to closely consider the antimicrobial technology to use, says van der Jagt. Roughly all of the technologies today rely on a migration principle. They have some active (and often toxic) substance migrating from the surface to act against bacteria. However, these uncontrollable technologies in fact contribute to antibiotic resistance as their functional substances can end up anywhere in the environment of the product creating more places for only the resistant bacteria to survive and proliferate. Taking AMR seriously means you focus on applying the technology only where you want to use its benefits. “This is really where our technology stands out,” explained Michael van der Jagt, CEO of Parx Plastics. “First of all our technology uses a body’s own element and on top of that our technology knows no migration, the performance is inert and intrinsic to the material surface. That means you have a targeted performance only on the surface where you want it and it does not end up elsewhere.” Foster also recently introduced Combat antimicrobial masterbatches for blending with medical device polymers. The company says that according to a survey by the Center for Disease Control (CDC), 4% of inpatients in US acute care hospitals contract at least one healthcare associated infection. Device associated infections accounted for one in

2018 HAS SEEN SOME INTERESTING ADVANCEMENTS AND EXPERTISE COME OUT OF THE MEDICAL PLASTICS SECTOR. AS ALWAYS IT’S HIGHLY ENJOYABLE TO LOOK BACK OVER THE LAST YEAR AND REMIND MYSELF OF THE EXTEND OF INNOVATION THAT COMES OUT OF THE INDUSTRY ON A REGULAR BASIS, SAYS LU RAHMAN

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O U W D

SECTOR HIGHLIGHTS

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O U W T D

every four infections. In-dwelling devices, such as central venous catheters, are particularly susceptible to bacteria colonisation which can enter the bloodstream. Ionic silver is successful at killing bacteria and preventing colonisation. Additives based on this chemistry are commonly melt blended directly into medical polymers for the manufacture on antimicrobial device components. However, evaluation of multiple custom compound formulations can be costly. “Combat master batches are available in quantities as low as two pounds to minimise costs for initial evaluations,” said Larry Johnson, executive vice president for Foster Corporation. “With let-down percentages of 2-10%, depending on the polymer and applications, these small order quantities allow engineers to test several antimicrobial formulations from a single order quantity.”

One of my favourite developments in the antimicrobial ﬁeld came via Parx Plastics

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MATERIAL WORLD Lorna O’Gara, Ultrapolymers, looked at polymer innovation in healthcare through intermaterial replacement Of course, any retrospective in MPN wouldn’t be worth its salt if it didn’t highlight the innovation taking place within the materials sector. Recently Vancive Medical Technologies’ Neal Carty explained how early collaboration on material selection can lead to bespoke adhesives — a path that may save some headaches in the long run. Carty outlined how as functional demands on medical devices become more complex, device developers may struggle to find standard, offthe-shelf adhesives that can help them achieve their desired product performance requirements. His expertise offered guidance for developers on some basic of the considerations to keep in mind during material selection and when partnering with a supplier to get it right the first time. One of Carty’s recommendations is customisation. He says that a materials supplier may be able to ‘mix and match’ different backings, release liners or adhesive types to achieve the desired performance. By doing so, the device developer can walk away with an adhesive product uniquely specialised for a certain end use, without reinventing the wheel. Lorna O’Gara, Ultrapolymers, looked at polymer innovation in healthcare through inter-material replacement. She noted that medical device manufacturers continuously strive to develop innovative products that are compliant with regulatory bodies and competitive, and that next-generation product development based on raw material innovation is one way OEMs can achieve this target. O’ Gara offered some valuable expertise for designers such as how to explore options for materials or consider rends such as those taking place in the drug deliver market which will help develop products that come in at a lower cost. She also asked readers to consider PVC alternatives and the use of materials such as INEOS Styrolution’s Styroﬂex, a styrene thermoplastic elastomer (S-TPE).

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WEAR IT WELL Tony Kaufman, and Del R Lawson,, outlined the role that adhesives play in digital wearable medical devices With the growing demand for wearables, it’s not surprising that the adhesives market has become a focal point for the medical plastics sector. When Tony Kaufman, and Del R Lawson, 3M’s Critical and Chronic Care Solutions Division, outlined the role that adhesives play in digital wearable medical devices, it was interesting to get their view on how adhesives may impact the future of wearable medical devices. Kaufman and Lawson outlined how many people habitually wear a device to track fitness or daily steps, nightly sleep and what they’re eating. Some people also wear devices to help manage chronic illness, such as diabetes. Consumers and patients are taking more control of their health by using real-time data collected by wearable devices to help make health-related decisions and want to proactively manage and improve their health without a device getting in their way. As a result, the wearable medical device market has seen rapid growth in recent years. The wearable medical device market will further evolve as researchers determine ways to improve current non-pharmaceutical therapies and digital monitoring. Manufacturers will need to put those findings into practice and build products that enable more effective, personalised monitoring to keep pace with market need. Their article examined the psychosocial impact of wearable devices; band vs. stick-to-skin applications; the danger of information fatigue; device size and weight; resilience and durability and comfort.

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How Schöttli technology helps meet the diabetes epidemic demand ISSUE 44

Sept-Oct 2018

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No highlights piece would of course, be complete if we didn’t look at injection moulding. One pf the most interesting pieces came in from Schöttli where Dominik Sinzinger, and Richard Gane, explained how the company’s high performance mould technology for plastic products helps with diabetes epidemic. The company constructs high-performance moulds in large quantities for medical applications including modern diabetes therapy, producing moulds for syringes to artificial pancreas devices. The diabetes sector requires the manufacture of pen needle components and safety pen needles and the components for these require moulds. Schöttli provides expertise in high-cavity injection moulds for medical components.

BREAKTHROUGH DEVICES

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FROM BUILDINGS TO MEDICAL DEVICE: HOW THESE ARCHITECTS CREATED A HEALTHTECH BREAKTHROUGH

IT’S NOT OFTEN WE HEAR OF A MEDICAL DEVICE BEING INSPIRED BY AN ARCHITECTURAL APPLICATION. ARCHITECTS TONKIN LIU HAVE DONE JUST THAT HOWEVER, TO CREATE A PRODUCT THAT COULD HELP PEOPLE WITH THROAT CANCER OR TRAUMA

ondon-based architects Tonkin Liu has used its architectural expertise to invent a medical device.

The practice, founded by partners Anna Liu and Mike Tonkin, has created a prototype stent for use in the trachea. The stent is a new type of shell lace structure – the practice’s signature single-surface structural technology designed and developed through a decade of research for architectural and engineering applications. It uses biomimicry to abstract principles from natural structures such as molluscs and plants. Working with engineers Arup and scientists from the Natural History Museum, the practice has developed a digital design and manufacture technology to make architectural sheet materials perform as efficiently as natural structures. Since 2008, the technology has been used in the design of ultralightweight pavilions, bridges and towers, and now for the first time to create a medical device.

Tracheal stents are commonly used to support transplants of the trachea and to treat collapsed airways in instances of throat cancer, trauma (eg car crash victims) and for the elderly. Stents are typically manufactured as a non-tailored tubular mesh, which due to poor fit makes them prone to slippage, causing injuries and infection and often requiring frequent replacement. The shell lace stent has been prototyped and developed using digital design software and 3D-printing technologies commonly used for architecture projects. The stent design is C-shaped rather than tubular, meaning its geometry can better adapt to the unique physiology of each patient. It is designed to be manufactured from medical grade silicone, with a perforated surface allowing for breathability and drug-delivery to the trachea tissues.

Mike Tonkin and Anna Liu with the Shell Lace Stent prototype Tonkin Liu’s designs for the Manchester Tower of Light (below) and Oval Court at the Lansdowne Club (overleaf) demonstrate the shell lace structure in architectural form WWW.MEDICALPLASTICSNEWS.COM

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www.phillipsmedisize.com The stent is inserted in its inverted position, and then unfurled to provide a ﬂexible and strong fit, with a natural outward pressure that lessens the risk of migration – a feature that the architects designed after analysing the geometric principles of Calla Lily petals. In 2014, Tonkin Liu published a book The Evolution of Shell Lace Structure to coincide with an exhibition of all its shell lace projects to date at the Royal Institute of British Architects. During a talk the architects gave in the exhibition programme, a clinical research scientist questioned whether the structural technique could be applied to the design of a small medical device, and soon after the practice’s quest to collaborate with the medical profession began. Obtaining funding from government-backed agency Innovate UK in 2016, the practice set about creating prototype stents using 3D-printing. To be suitable for medical use, the resulting shell lace structure was 500 times smaller than those previously created for any architectural applications.

Following numerous design iterations and successful testing, the shell lace stent has now been approved as patent pending. Tonkin Liu are working with research partners andmedical experts to bring the innovation to market, as well as exploring broader applications of the technology for other parts of the human body.

Partner Mike Tonkin comments: “This project is small in scale but grand in ambition. It demonstrates how architects can apply themselves beyond architecture – how we candesign things other than buildings. We hope now to bring the Shell Lace Stent to manufacture and we can design things other than buildings. Our aim is now to bring the shell lace stent to manufacture stage and see it bring tangible benefits to patients globally. “We need to collectively reimagine the role of the architect – the architecture sector has great potential to engage with different realms and professions. As we all live longer and make greater demands on the medical profession, we should all look to use what skills we have (in our case advanced digital design and fabrication) to collaborate and benefit society.” With its inverted surface and structure and other novel features, the prototype has drawn excitement from leading medical experts. Professor Martin Birchall, UCL professor of laryngology and consultant in ENT Surgery at the Royal National Throat, Nose and Ear Hospital heralded it as “a remarkable and unprecedented stent invention, that is groundbreaking in the context of currently available devices.”

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The flexible nature of the shell lace stent mimics natural process to ‘unfurl’ to create an optimal fit for each patient once deployed The perforated structure of the shell lace stent

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COMPAMED

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How to get the best out of COMPAMED 2018 With so much to see inside the many halls and corridors of Messe Düsseldorf, here’s deputy group editor Dave Gray’s guide to everything you’ll need at this year’s Compamed. COMPAMED – IT’S ALL ABOUT IMPLANTS Every year Messe Düsseldorf and the IVAM Microtechnology Network team up at a spring convention to forecast key trends for the event. This year the conversation was dominated by talk of new and futuristic implants. Researchers from the International Trade Administration and BCC Research have valued the sales volume of medical implants at €30-60 billion, of which ‘active’ implants constitute around €15 billion. ‘Active’ refers to any implant that is fitted with an energy supply, typically a battery. Dick Molin, medical market segment manager for Compamed exhibitor Specialty Coating Systems (SCS) explains the impact of the trend towards active implants on the supply chain: “The new combinations of types of technology and the integration of electronics, smaller and smaller components, high frequency and wireless technology as well as monitoring, recording and control systems are market drivers for implants at the moment.”

trends are currently setting the pace. For quite some time now, ‘dematerialisation’ and ‘digitalisation’ and ‘networking’ have been buzzwords that quite fittingly describe the events around medical technological product development and are still extremely current.” Giesen added: “Providers are turning to suppliers to seek ever more delicate, lighter and at the same time more advanced components such as sensors, chips, wireless modules and even accompanying energy savers or information savers.

New materials, innovative procedures and the combined application of electronics and microsystem technology are set to be fundamental themes at Compamed this year. Horst Giesen, global portfolio director for health & medical technologies at Messe Düsseldorf said in a statement ahead of this year’s show: “Exciting

Photographs: Messe Düsseldorf/ctillmann

“These then can be installed in wearables used for diagnostics of vital signs. These devices are in high demand. Another large application is the field of active implants. Participants in this year’s Compamed Spring Convention have already learned why these are among the most technically sophisticated medical products with particularly high research, development, production and approval requirements and which are currently the most interesting innovations in this area.” A MATERIAL WORLD While miniaturisation and digital tech are both key trends expected at Compamed this year, more conventional materials are also set to feature. German chemical giant Henkel, for example, will be showing a new collection of products including LED WWW.MEDICALPLASTICSNEWS.COM

COMPAMED

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curing adhesives for flexible medical devices, a range of advanced pressure sensitive adhesives for plasters and functional patches as well as conductive inks for smart health devices. While these new materials may only really be new iterations of existing technologies, Henkel also believes that new trends are changing the game. The firm says that the spotlight will be on new acrylic adhesives developed for use on flexible applications made of thermoplastic elastomers (TPE) and thermoplastic polyurethanes (TPU), two substrates increasingly specified by device manufacturers. As low-viscosity, LED curable and high-flexibility adhesives, they feature tack-free curing and combine high elongation (>200%) with outstanding bond strength also on polycarbonate, acrylic and other rigid plastics used in medical devices. “Using LED curing saves costs, thanks to the fact that it can be switched on/ off instantly. Additionally, the narrow spectrum of light wavelength without infrared light emissions helps manufacturers save energy consumption and minimises the generation of heat that must be dissipated, especially in cleanroom bonding applications,” said Andrés Bultó, business development and key account manager, medical at Henkel. “When developing our new LED cure adhesives, our aim was to add further value by enhancing their flexibility and design freedom, while at the same time maximising their bonding strength. Notably, the property profile includes fast LED curing in all geometries, from bondlines to open fillets,” he added. As discussed, implants have seen a trend towards ‘active’ technologies, but woundcare is also moving in a similar direction. Reflecting this trend, Henkel is also presenting its new hydrocolloid hot-melt pressure sensitive adhesive. This innovation targets the fast-growing demand for functional medical plasters and advanced patches for use in applications such as advanced wound dressings, acne treatment and ostomy care. If digital health is more your thing, there’s plenty of cutting-edge tech on display at Medica, but what about the tech behind the tech? Henkel says this year it is targetting smart health devices, such as disposable moisture sensors for incontinence management and comfortable on-body health patches for real-time wireless patient monitoring using novel dry-electrode materials. IT’S ALL ABOUT THE SERVICE While many players like Henkel will be pushing new product lines at Compamed, others will have other developments to share. Materials group Eastman, for example, has opened a brand new European Technology Center in Ghent, Belgium in the time since the last edition of the show. Device manufacturers can use the show as an opportunity to find out what’s on offer at the new facility. In a sneak preview, Eastman revealed that the facility is based at Ghent University’s technology park, and its staff work with customers from design conception to implementation, as well as helping to address production challenges as quickly as possible. Onsite medical plastics experts are also working closely with Eastman’s other R&D centres across to globe to accelerate the development of future-forward technologies, including performance compound technology and bio-based alternatives, the firm said. “We offer the right plastic now, to enable customers in the medical sector to succeed today. We are also continuously investing in more sustainable business solutions that will help them perform tomorrow. Innovation lies at the heart of our offering,” said Cedric Perben, Eastman Technology. Another firm with news of an expansion (or, rather, multiple expansions) is Carclo Technical Plastics. Carclo has recently expanded its medical operations in its US, UK, Czech Republic, China and India facilities as it continues its strategy of increasing its contract manufacturing business globally. Underpinned by its EN13485 accreditation, the firm says it has won significant new business in the healthcare, medical diagnostics and eyecare fields during 2017/18, and will be planning on sharing its new capabilities with visitors to the show. Commenting on the growth, divisional chief executive officer Robert Stutzman said: “Carclo Technical Plastics has aggressive plans to continue developing

our medical business, supported by Carclo’s engineering skills, global footprint and financial stability. Compamed, co-located with the renowned Medica tradeshow, is one of our prime marketing activities and we invite all customers and prospective customers to meet with us during the week.” HIT PRINT 3D printing remains a hot topic at Compamed. According to a forecast by market research company Markets and Markets, global 3D printing for medical products is expected to increase from 840 million US dollars in 2017 to around 1.9 billion dollars by 2022, a yearly growth rate of 17.5 percent. Last year, Compamed’s seminar “3D fab+print” went down a storm. For 2018, it will be followed up with an all-day conference on the subject – possibly Messe Düsseldorf’s most significant foray into the field. Among the companies presenting is Evonik, which has been systematically working on improved materials for orthopaedic surgery in their project house Medical Devices since 2014. “We are developing new solutions that help prevent operations or accelerate the healing process,” said project house manager Balaji Prabhu. Evonik is well-placed to talk on the subject, having been responsible for developing a composite that consists of the polylactic acid ‘Resomer’, and a synthetic hydroxylapatite filler. Hydroxylapatite is the most common bio-mineral in the human body, resulting in mechanical characteristics that are very similar to those of natural bones. Resomer is completely degraded into carbon dioxide and water in the body, does not cause inﬂammatory reactions and is completely non-toxic.

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DRUG DELIVERY

BILL WELCH, PHILLIPS-MEDISIZE, A MOLEX COMPANY, SHARES HIS INSIGHTS ON THE TRENDS DRIVING GROWTH IN CONNECTED HEALTH SOLUTIONS Q. WHY IS THERE AN INCREASING INTEREST IN INVESTING IN CONNECTED HEALTH SOLUTIONS IN THE DRUG DELIVERY MARKET? A. Integrating mobile and cloud technologies into drug delivery devices such as injectors and inhalers provides exciting opportunities for improving patient medication adherence, which has proven to be a persistent – and costly – challenge. A number of studies show that only half of the patients in the United States take their medication as prescribed, costing approximately $290 billion annually. Improving how people take their medicine offers powerful potential for better patient outcomes and lower healthcare costs. Q. HOW DO CONNECTED HEALTH SOLUTIONS ADDRESS THE ADHERENCE CHALLENGE? A. Using connectivity in drug delivery devices enables patients and healthcare professionals to track when patients take their medication and the dosage amount. A device design with the patient and disease in mind, coupled with an app, creates a stronger patient use experience. Connectivity provides opportunities to support patients through reminders, incentives and peer communities to improve adherence, disease management and, ideally, outcomes. For example, the third-generation connected health platform recently released by Phillips-Medisize makes it easy to do all this and more. It builds on the success of our earlier connected health solutions, including the first FDAapproved combination product for medication adherence. Our cloud-based connected health platform is a scalable medical device data system (MDDS) that combines a rich analytics tool with an integration engine so that customers can integrate patient data with electronic medical records and other data from pharmacy and IoT devices. Analyzing this data can provide valuable insights to help drive better medication adherence. Q. WHAT ARE THE CORNERSTONES OF EFFECTIVE CONNECTED HEALTH SOLUTIONS? A. Connected health solutions should be developed around therapy-specific

interfaces that create compelling user experiences. They must be sensible, scalable and cost-effective to meet industry, provider and patient needs. Based on more than a decade of experience developing connected health solutions, we recognize that successful ones are built on three essential foundations: robust technology, solid business planning and empathetic patient engagement. It is critical for developers to continually invest in new capabilities, technologies and human expertise to ensure they deliver high-value solutions that incorporate the best in innovative thinking. Developers need to work closely with customers to develop differentiated and drugspecific strategies that support connected health value propositions and deliver strong ROI. As part of our commitment to this emerging market, we recently expanded our Little Rock Facility to include an FDA-registered manufacturing Center of Excellence for Connected Health and drug delivery devices. Q. WHY IS PATIENT-CENTERED DESIGN IMPORTANT? A. The ultimate goal of connected health solutions is to enable patients, supported by their caregivers, to improve medication adherence and take better care of themselves outside the hospital, with additional support and encouragement from healthcare providers as needed. That means connected health solutions should be simple to use and desirable from the patient’s perspective. Welldesigned interfaces help patients remain engaged and motivated, provide a great user experience and streamline data collection and visualization. Q. WHAT DO YOU ANTICIPATE FOR THE FUTURE OF CONNECTED HEALTH? A. We expect the market to grow globally, with the biggest initial growth in the United States and Europe, as connected health systems begin to demonstrate incremental improvements in adherence and patient outcomes. For us, connected health is not a buzz word – it’s a strategy for better serving our customers and their patients.

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BIOABSORBABLE POLYMERS

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Bioabsorbable polymer mesh GETS FDA SEA OF APPROVAL SURGICAL INNOVATION ASSOCIATES RECEIVES FDA CLEARANCE TO MARKET ADVANCED BIOABSORBABLE MESH FOR RECONSTRUCTIVE AND COSMETIC SURGERY

urgical Innovation Associates (SIA), a start-up medical device company, has received 510(k) clearance from the US Food and Drug Administration (FDA) for DuraSorb Monofilament Mesh. It is said to be the first in a line of advanced bioabsorbable technologies for reconstructive and cosmetic surgery. Each year, more than 1 million Americans are implanted with surgical mesh to provide the soft tissue support that is necessary in a variety of general and plastic surgical procedures. Much like an absorbable stitch, DuraSorb Monofilament Mesh is designed to integrate into the patient’s tissue – providing strong support during the critical initial phases of healing – and then slowly dissolve, leaving the patient free from foreign material within one year. The device brings polymer science and evidence-based engineering to bear on a material that has been used in other surgical applications for decades. DuraSorb will be released in select geographies in early 2019. “The idea of a mesh that is there when you need it and gone when you don’t , is appealing, for much the same reason that absorbable sutures have become a key part of a surgeon’s armamentarium – tissue support from a foreign material is crucial during healing, but at some point thereafter may become a liability,” said Dr John Kim, inventor of the device and professor of Plastic Surgery at Northwestern University. “This technology was developed in direct response to unmet clinical needs in our field.” Complications following mesh placements can range from long-term pain to non-healing wounds. Historically there

has been a dichotomy between permanent synthetic meshes and biologic meshes. Permanent synthetics provide favorable longterm support in hernia surgery and abdominal wall reconstruction. However, they are known to expose patients to long-term risk of pain, non-healing wounds and complications during later operations. Biologic meshes – derived from human or animal cadavers – promise long-term biocompatibility once they integrate into the patient’s tissue, but carry excessively high cost, risk of adverse inﬂammatory reactions and mixed clinical results. “Having known people who have gone through the pain of multiple mesh-related operations, I found it gratifying to collaborate closely with opinion-leading surgeons to make DuraSorb a reality,” said Alexei Mlodinow, CEO of SIA. “Their guidance went into every key decision during product development, and will now steer our clinical trial strategy as we replicate our robust preclinical data in a real-world setting.”

Much like an absorbable stitch, DuraSorb Monofilament Mesh is designed to integrate into the patient’s tissue

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MATERIALS

RESISTANCE TRAINING INCREASINGLY AGGRESSIVE DISINFECTANTS ARE PRESENTING MEDICAL DEVICE AND EQUIPMENT MANUFACTURERS WITH NEW MATERIAL CHALLENGES. CEDRIC PERBEN, EASTMAN TECHNOLOGY, EXPLORES ADDED CONFIDENCE IN MATERIAL CHOICES

he increasing chemical harshness of disinfectants used on multi-use medical devices and equipment is designed to keep patients safe. A trend which is unlikely to go away, with stringent targets being set to reduce Hospital Acquired Infections (HAI) across the developed world. However, retaining the form and function of medical devices and housing made from medical-grade polymers is proving difficult. Harsh cleaning, designed for patient safety, can shorten equipment life and increase medical costs; as well as putting patients’ lives at risk. This is why collaboration across the value-chain and proven methods of assessing material performance are more important than ever. SAFER, QUICKER AND STRONGER Protecting patients, alongside the smooth running of hospitals, is the top priority. So, cleaning ﬂuid manufacturers will continue to develop stronger disinfectants to kill bacteria as quickly as possible. Packaged wipes, with potent chemicals pre-applied are proving more convenient and hygienic. This supports medical centres looking to improve cleaning productivity. Add to this the trend for distance medical support and it is easy to understand the growing preference for powerful cleaning wipes and cloths. MEDICAL DEVICES AND HOUSING UNDER ATTACK For many medical devices, retaining clarity of clear casing is fundamental to visibility of key functions. Discoloration of the plastic surfaces, caused by chemical cleaners, can impact both user and patient confidence. Chemical attack from disinfectants and solvents may take its toll immediately, but more often it results from repeated exposure and every day stress. Once plastic materials start to feel sticky, or look hazy or craze or crack, the device can be compromised and patient treatment disrupted. Device manufacturers are looking for more assurance that the medical-grade plastics they choose have both the durability to withstand today’s mobility demands and deliver impressive chemical resistance. Claims of chemical resistance of copolyesters for housing, as well as medical devices, need to be proven with specific chemicals.

Some materials are compatible with bleach and hydrogen peroxide, but are vulnerable to isopropyl alcohol or Virex Tb. Others may be compromised by medical disinfectant wipes. Manufacturers and converters are looking to collaboration and testing protocols with specialty chemical companies to better understand chemical tolerances and performance. COLLABORATIVE PROBLEM SOLVING Eastman uses a collaborative total solution approach, working with businesses across the whole value-chain to understand material performance from multiple angles. Our work with Clorox Healthcare led to the introduction of its latest hydrogen peroxide cleaner disinfectants and bleach germicidal wipes. The product’s disinfectant rates were evaluated with common medical device materials using our four-step testing protocol. This demonstrated the advantages of collaboration and standard testing methods in the delivery of product performance. FOUR-STEP TESTING PROTOCOL The Eastman four-step testing methodology has been designed to assure manufacturers they are choosing the right plastic material for their specific application. It interrogates material for typical ‘in-use’ stress and is a quick and convenient method of understanding chemical resistance – taking one to two days to complete. Firstly, a curved metal jig is used to accelerate the process of stresscracking. This is loaded with plastic ﬂex bars for testing. Once the cleaning solutions have been applied to the bars the entire sample is sealed in a plastic bag. This prevents evaporation. The test is left at room temperature for 24 hours and then a reverse side impact test is used to check for changes that are not visible to the human eye. Impact strength retention is calculated using a control ﬂex bar. Higher retention values indicate better material performance when subjected to harsh chemical cleaners.

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MATERIALS

Making the grade CARL MENDONÇA, ULTRAPOLYMERS, OUTLINES POLYMER CHOICE CONSIDERATIONS FOR SUCCESSFUL PLASTICS DEVICE COMPONENT DEVICE

umerous studies have pointed to growth in aging populations coupled with greater demand for healthcare in the coming decades. As solutions to deal with increasing demand for treatment – and medical devices - are sought, the challenges for device designers are plentiful. One of these challenges is to use materials that meet increasing legislative demands, are cost-effective, user-friendly and also meet increasing environmental demands. When it comes to polymer choice for device components, compliance with evolving regulatory requirements for risk management needs to be considered alongside competitive and innovative drivers. New therapies and treatment advances mean therapy delivery technology has to evolve to match. Polymer technology similarly evolves with new grade introductions with improved properties such as lubrication, antimicrobial content, glass/metal replacement capabilities etc. The Medical Device Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR) bring a higher degree of scrutiny as greater traceability and risk management become necessary. The polymer (combination) chosen should meet or exceed the renewed legal requirements. Intensified communication between all stakeholders to clearly set out performance expectations of the chosen material(s) becomes key. Disclosure of information about formulation consistency, consistency of supply, change management or notification of change becomes increasingly valuable or even a prerequisite for correct material selection. These discussions will highlight possibilities, limitations and risk management options for all stakeholders. In light of the above, a polymer should vary as little as possible – careful consideration should be given to the controls in place at each stage to minimise variance – communication again being key. Discussions at the very start of a new project design (or even a modification of an existing product) on suitable polymer choice should consider all requirements of the The challenges for device designers are plentiful, says Carl Mendonça, Ultrapolymers

polymer performance and compare these to available polymer types and grades to arrive at a shortlist for further consideration. Discussion with technical support advisors from the polymer industry will greatly aid this process. A study by RAPRA showed that just under 50% of product failures investigated could be attributed to the material selection process. Hence the earlier the stage at which materials are considered (preferably the product design stage), the better the chance of an optimal choice. Material choice consideration should include all parties from designer to material supplier, toolmaker, moulder and end user. This establishes ‘must have’ and ‘nice to have’ lists of material properties. The ‘must have’ list should be challenged to ensure that the designer/end user is convinced of the absolute necessity. Factors to consider include physical requirements, colour, sustainability, processing requirements, environment of use, specifications, approvals, assembly or secondary operations, etc. Responses will determine if an amorphous or semi-crystalline material is more suitable. Amorphous materials tend to have more constant physical properties, better dimensional stability over temperature variation and generally better transparency. Semi-crystalline materials tend to have better chemical resistance, higher stiffness and wear resistance, as well as other properties. If the part is to be coloured, then how this is achieved needs careful consideration to ensure consistency. Physical requirement considerations include final use conditions – single impact or repeated, operating temperature, stiffness requirements etc. Will a standard grade meet the requirements or will a modified grade be required? If modified, will the material meet regulatory requirements? Is the part under load over an extended period – does creep performance need to be considered? Chemical resistance can really only be tested on the final design and with the relevant chemicals. Time, temperature and concentration will determine performance as well as conditions of test – if the part is under stress (load) or strain (extension), chemical resistance can be affected. Cleaning solutions also need to be considered for potential effect on material performance. Although chemical resistance tables and information are available, it is always best to test using real conditions, as leachable or extractable elements could also affect performance in the final application. This article aims to provide a starting point for rounded discussions about product design and application requirements such that all stakeholders contribute to the decision-making process on material selection coupled with part design. All parties should evaluate the importance of inﬂuencing factors from their own aspect as well as others. Only then can a consensus be sought to progress towards a successful outcome.

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Choosing plastics for medical devices and housings can be challenging.

Disinfect

with confidence.

Many common cleaners can cause plastics to crack, craze, discolor, or become sticky. Health care facilities need powerful disinfectants to help prevent the spread of infection-causing pathogens via surfaces. So how can you be confident in the plastic you choose?

TEST PLASTIC MATERIAL PERFORMANCE USING THIS SIMPLE 4-STEP TEST.

Select the appropriate jig.

Load flex bars onto jig.

Choose the strain level that most appropriately reflects environmental stress cracking.

Remember to load some control samples that will not be exposed to chemicals.

Apply chemicals to the flex bars using presoaked pieces of cotton.

Chemicals such as commonly used hospital disinfectants, lipids, drugs, or drug carrier solvents can be used. Enclose the entire sample jig in a plastic bag to prevent evaporation and leave at room temperature for 24 hours.

Perform reverse side impact test. This is the differentiating step.

Unload the samples, and run a reverse side impact test on the exposed and control samples.

To learn more about Eastman polymers for medical devices and housings, visit Eastman.com/medical ÂŠ 2018 Eastman. Eastman brands referenced herein are trademarks of Eastman or one of its subsidiaries or are being used under license. The ÂŽ symbol denotes registered trademark status in the U.S.; marks may also be registered internationally. Non-Eastman brands referenced herein are trademarks of their respective owners.

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MATERIALS

WHY INN VATION MATTERS Roger Hendrick, Specialty Products Division of DowDuPont, and Carolin Vogel, Specialty Plastics, Eastman Chemical Company, explain how new technology broadens medical device materials and design options

o support the growing, multi-billion dollar medical device industry, injection mouldable materials suitable for healthcare applications are continuing to improve and expand design options for device manufacturers. New liquid silicone rubber (LSR) technologies in conjunction with copolyester are making it possible to combine the benefits of each technology in overmoulding applications. Silicone elastomers have been used in medical applications since the 1940s and have changed to meet the demands of end-use application requirements and processes which manipulate them. The properties of silicone materials can be inﬂuenced by their formulation and may provide different application benefits, but generally afford characteristics such as thermal and chemical stability, high gas permeability, hydrophobicity, biocompatibility/biodurability and high elasticity. While not an exhaustive list, many of these characteristics benefit medical applications and their suitability for various sterilization methods such as autoclave, ethylene oxide (ETO) and gamma or electron beam radiation. FORMULATION IMPROVEMENTS Suppliers of liquid silicone rubber have made formulation improvements since their inception in the 1970s changing to meet application requirements of cured physical properties and their stability when exposed to post-processing conditions. In some cases, specialty LSR formulations have been developed to impart unique characteristics either in the uncured behaviours or in the cured component. This is evident in new low temperature and self-adhesive LSRs. Copolyesters, as silicones, have several decades’ long history within the medical device industry. Manufactured into medical devices via thermoplastic conversion processes, such as injection moulding, their value lies in their unique set of properties. These include: toughness, clarity, their advantageous regulatory profile, such as being free of BPA, and their chemical resistance. THE EFFECT OF STERILISATION In today’s health care environment,

it is becoming more common to see medical devices that don’t work satisfactorily. They are unable to do their job—or fail prematurely—because of environmental stress cracking (ESC) or other defects resulting from exposure to disinfectants and other chemicals. Aggressive disinfectants and sterilisation in combination with more frequent disinfecting procedures take a high toll on devices moulded with commonly used polymers. Brand owners are addressing this challenge by using polymers with a higher level of chemical resistance. The selection of these high-performance materials early in the design process is one of the most critical considerations for the future of patient safety.1 Testing and evaluating chemical resistance needs to be performed to answer questions around chemical compatibility of materials with various cleaners and disinfectants utilized to maintain medical devices in the healthcare industry. Desirable performance is to have little or no stress cracking or haziness from contact with cleaners and disinfectants, or from lipids, bonding solvents or drugs and their carrier solvents. Copolyesters as well as silicones have shown being high performing materials regarding chemical compatibility and therefore get chosen frequently in medical device applications. Colour-stable, transparent medical devices are of the utmost importance in the healthcare field as they embody the idea of safety, quality and peace of mind for both the patient and the healthcare professional. Though many factors must be taken into consideration when deciding which polymer to choose in the development of a medical device, understanding the effect of sterilisation is critical. The objective of sterilisation is to reduce the bioburden to a safe level, while minimizing any changes to the physical and optical properties of the final part. The most common effect on polymers exposed to radiation is a shift in colour to yellow. In the medical device market, a significant colour shift to yellow is undesirable as it may be interpreted as a contaminated device.

Therefore, minimal shift in the polymer color after sterilisation can be an important factor when specifying a polymer for a medical device or rigid thermoformed package. Various copolyesters are suitable for nonautoclavable sterilisation methods such as gamma or electron beam (e-beam) radiation regarding color shift and retention of mechanical properties. BRIDGING THE GAP While heritage copolyesters as PETG, PCTG, and PCTA that were introduced into the market in the last century have heat deﬂection temperatures (HDTs) in a range of 67°C to 74°C (@0.455 MPa/66 psi; ASTM D 648), newer developments of copolyesters in the recent two decades have higher HDTs of between 94°C and 109°C. This is one necessary step to bridge the gap for over moulding copolyesters with silicone. Injection molding with traditional liquid silicone rubber products is commonly done at temperatures near 150°C or greater to assure rapid cure of the silicone component which far exceeds the heat deflection temperature of traditional copolyester preventing traditional silicones from being considered in copolyester overmolding applications. NEW PRODUCT TECHNOLOGIES New liquid silicone rubber product technologies, however are now available to challenge those traditional processing concepts with improved cure rates at low cure temperatures. This makes available the possibility to injection mould with mechanical interlock or with self-adhesive properties at temperatures below critical substrate heat deﬂection temperatures whilst maintaining necessary cycle times. During a time when an aging population requires new ways to cure diseases and manage chronic conditions, it is important that companies innovate and collaborate to deliver solutions that matter. By merging technologies to meet the needs of manufacturers and ultimately patients, one can positively impact the way healthcare is addressed globally and contribute to greater health outcomes and improved quality of life.

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HIGH PERFORMANCE for the healthcare sector

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TPE COMPOUNDS

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SHOCK TACTICS FRANCESCO FRANCESCHETTI ELASTOMERI LOOKS AT THE ROLE OF ANTI-STATIC COMPOUNDS

lastic materials are electrical insulators by their own nature. This feature is usually a positive in most applications but it can generate problems when the final product undergoes rubbing stress. In such conditions the material accumulates electrostatic charges which are responsible for the ‘shock’ received when touching an electrified object. The problem of the accumulation of electrostatic charges has increasingly become an aspect of legislative relevance so it is regulated by various sector directives. Many TPE compounds are based on styrene-butadiene-styrene block copolymer (SBS) and styrene ethylbutylene styrene (SEBS) are excellent insulators as well as all plastic materials so they tend to accumulate electrostatic charge naturally. The tendency to accumulate these charges is inversely proportional to the specific resistivity of the material: higher resistivity means the material is more insulating ie. it does not conduct electrically and, therefore, it does not allow the electrostatic charges to dissipate/discharge to ground. Electrical resistivity is the inverse of electrical conductivity. Electrical conduction mechanisms can be inﬂuenced by surface interface effects (eg. relative humidity of the environment) causing electrical conduction essentially localised on the surface of the material; in this case we speak of surface resistivity that must be distinguished from the specific resistivity or volume resistivity. • specific resistivity (or volume resistivity) is measured in Ohms*cm. • surface resistivity is measured in Ohms but the unit of measurement Ohm/sq is usually preferred. Nevertheless, it is possible to exhaust the build-up of electrostatic charge. The conductive properties of compounds depend strongly on the fillers choice and how they are dispersed within the thermoplastic matrix. The main methods for modifying electrical conductivity in a thermoplastic elastomer can be achieved through the addition of: UNMIXABLE PARTICLES OF CONDUCTIVE MATERIALS The electrical conductivity occurs thanks to the contact of conductive particles that create a network within the thermoplastic material. Some examples of such particles are: conductive carbon black, metal microfibres, carbon nanotubes... etc. There are three conditions that must be met to achieve an effective and long-lasting conduction mechanism: 1. The concentration of conductive particles must necessarily be high; 2. The dispersion of these particles in the thermoplastic matrix must be homogeneous; 3. Thermoplastic matrix itself must be dimensionally stable to guarantee the electrical contact between the conductive particles.

One of the drawbacks is that the high concentration of such particles heavily alters the characteristics of the base material, the other refers to ﬂexible materials and in particular to elastomers which, by their nature, cannot satisfy the third requirement of dimensional stability; this type of electrical conductivity in the elastomers and destined to be variable over time as a function of the operating conditions of the elastomer article. MIGRANT IONIC AND/OR HYDROPHILIC ADDITIVES These additives migrate on the surface of the material, activating an electrical surface conductivity through time. For this reason, they are easily removed so the dissipative effect is destined to decrease over time. These additives are commonly referred to as ‘non-permanent antistatic additives.’ INTRINSICALLY CONDUCTIVE POLYMERS (ICP) The conduction mechanism is activated by a homogeneously dispersed polymer component in the thermoplastic matrix; in this case the conduction mechanism is activated by a homogeneously dispersed polymer component in the thermoplastic matrix; this mechanism guarantees a much more stable electrical conductivity over time (permanent) and independent of mechanical and/or environmental stresses applied to the material. The main drawback of this mechanism is that to activate an appreciable electrical conductivity the concentration of ICP must be elevated with repercussions on the final characteristics of the thermoplastic material. The conductive properties of the compound strongly depend on the choice of fillers and how they are dispersed inside the thermoplastic matrix but only if ICP are used, the resistivity of the object is permanent. Francesco Franceschetti Elastomeri has developed three new families of anti-static TPE compounds: Marfran E CD. These compounds are based on technologies that make the antistatic material both non-permanent (ionic additives) and permanent (ICP), combine the easy processability, lightness and versatility of TPE with the dissipation properties of the electrical charges.

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CATHETERS

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Playing it safe IKER PRINCIPE, CIKAUTXO OFFERS HIS EXPERTISE FOR MANUFACTURING ANTI-THROMBOGENIC CATHETERS

entral venous catheter (CVC) use is a common practice in the critical care system but many patients have associated multiple risk factors for venous thromboembolism. CVC insertion has inherently associated a seldom but the realistic risk of catheter-caused thrombosis and, due to its point of insertion, is certainly uncomfortable for the patient. For non-irritant treatments and longer periods of insertion there is another more comfortable and safer alternative for the patients â&#x20AC;&#x201C; peripherally inserted catheters. PERIPHERALLY INSERTED CATHETERS Peripherally inserted central catheters (PICCs) are used to obtain central venous access in patients undergoing treatment in acute care facilities, home health agencies, cancer centers and skilled nursing care in a variety of settings. In comparison with CVCs, PICC insertions are less invasive with decreased complication risk and the PICC, being

also less uncomfortable for the patient, can remain indwelling for a longer duration than other acute central access devices. PICC typical indications are longterm chemotherapy, hyper-alimentation, antibiotic therapy, repeated infusion of blood or blood products, venous blood sampling, reduced number of needle punctures to skin and measurement of central venous pressure among others. The PICC is usually placed today using an ultrasound technology to visualise a deep, large vessel in the upper arm and it is inserted by a specially trained and certified PICC nurse specialist or by an interventional radiologist. Ultrasound placement has been demonstrated to reduce the number of punctures per patient during insertion and is of greatest importance with those patients that are most difficult to insert (eg obese patients). The entire procedure can be done in a patientâ&#x20AC;&#x2122;s room decreasing discomfort, transportation and inefficiencies of other usual care procedures.

As per some expert sources report, the PICC use is constantly growing and still expected to grow significantly in Europe in the next following years (see graph).

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Are you fit for the MDR? Get up and running! The new European Medical Device Regulation (MDR) was adopted by the European Parliement on April 05, 2017 which will come into force after the publication in the offical journal. It will not only replace the current Medical Device Directive; experts anticipate drastically stricter regulation for virtually all medical device manufacturers in Europe. A variety of challenges for the manufactures but also for the other actors in the field of medical device are envisaged. Despite a transition period of 3 years timely start is recommended.

We have been an independent service provider for the chemical, pharmaceutical and medical device industries since 1996 with currently over 550 employees at the sites within Europe, Asia and the USA. For further information visit www. knoell.com or call us.

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CATHETERS

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Based in this advantage of the peripheral insertion, a new family of catheters is appearing as an alternative to PICCs in those cases where the tip of the catheter can remain peripheral and does not need to go central: the midline catheters. THROMBOSIS RISK With a clear trend towards an increased use of peripherally inserted catheters, the incidence of catheter-related thromboembolism diseases is likely to increase further. There are several risk factors for the development of catheter related thrombosis. They can, broadly speaking, be categorised as risks relating to three factors: the catheter itself (for example, the catheter to vein ratio is critical), the insertion process and the patient factors. It is useful to remember, in this context, how these factors relate to Virchow’s triad of endothelial damage, stasis and hypercoagulability, described as the components involved in a thrombus formation. As a consequence, venous thrombosis has to be regarded as a multifactorial disease. In addition, in a substantial proportion of thrombosis patients, their risk factor of thrombosis is not easily detectable. Thrombotic complications associated with the use of venous catheters lead to distressing patient symptoms, catheter dysfunction, increased risk of infections, long-term central venous stenosis, and considerable additional costs for the healthcare system. ANTI-THROMBOGENIC CATHETER SOLUTIONS Symptomatic catheter-related thrombosis is treated with anticoagulation, generally without removing the catheter. The intensity and duration of anticoagulation depend on the extent of thrombosis, risk of bleeding, and need for continued use of a catheter. To date, the clinical benefit of prophylactic doses of anticoagulant has been somehow disappointing. Some European catheter manufacturers are therefore offering power-injectable and effective PICC and Midline antithrombogenic catheters in the European market: it is the case of Cikautxo Medical, a Basque company specialist in silicone and thermoplastic catheter manufacturing in combination with value added solutions proposals. Its CEO, Iker Principe says: “Our customers, the big catheter branded manufacturers, can select, among other solutions, our anti-thrombogenic vascular access devices based in a covalently bonded heparin attack obtained after a sequence of different surface modifications of the original material of the catheter, which avoids clot generation not only in the catheter surface itself but also on the surface of the blood vessel”.

A midline catheter positions the tip of the catheter in the clavicular vein area (usually the axillary or subclavian veins) and for this reason are not considered class III Medical Devices, opening the possibilities of insertion to a wider range profile of medical qualified human resources. This advantage opens an excellent cost saving opportunity for hospital management. Today different varieties of midlines are being launched in the market, like the mid-clavicular, the short-midlines, the mini-midlines, others.

Cikautxo PICC sample

A useful way to differentiate those Vascular Access catheters can be regarding their insert location and their tip placement:

Device

Primary Use

Insertion Location

Short PIVC

Provides short term (few days) access to peripheral veins to administer medication or ﬂuids

Peripheral

CVC

To intravenously administer drugs and ﬂuids and monitor central venous pressure

Central

PICC

Primarily long-term (weeks to months), to intravenously administer drugs or ﬂuids

Peripheral

Central

Midline catheter

To intravenously administer drugs or ﬂuids, not central but closer to bigger veins

Peripheral

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A VERY PARTICULAR KIND. is our innovative solution for the development of new products for biocompatible medical devices. MARFRAN.MED®... your partner for high-tech compounds !

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Precision Welding For Critical Plastic Components. The Branson GSX ultrasonic welding platform meets the growing demand for the assembly of smaller and more complex plastic components. Precise welds are achieved utilizing an advanced electro-mechanical actuation system that provides unprecedented control and position accuracy, while applying the industry’s lowest trigger force. The Branson GSX can also weld across multiple parameters, monitored in real-time to ensure quality. This is possible with a wide range of input materials and best-in-class repeatability across multiple Branson GSX welders.

For product information: Emerson.com/Branson

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INJECTION MOULDING

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HOLD SPEED OR HOLD VELOCITY? HOW MANY MACHINES TODAY HAVE IT AND WHAT DOES IT DO TO YOUR PROCESS? HOW SECOND STAGE SPEED INFLUENCES YOUR PROCESS. BY SHANE VANDEKERKHOF, RJG

he machine controller input of hold velocity started to become more and more prevalent with the onset of electrically-driven moulding machines. The setting tells the machine how fast to move the screw during second stage. But, and this is a big but, second stage is a pressure limited portion of our process. You can’t have velocity control on a pressure limited portion of a process. So how effective is the speed setting then?

Figure 1: Second Stage Speed vs Machine Response

The moulding machine will use the speed that is input into the machine controller only until the set second stage pressure has been reached. Once your second stage pressure is reached, you will notice that the screw slows down and may even eventually stop. We look at this velocity input as a matter of response time. The setting is telling the machine controller how fast you want to get to the second stage pressure setting. So the question becomes: “Does this setting impact my process?” The answer to that question is simple: Yes. Below you will find a couple of graphs that represent first, the injection pressure profile and secondly, the part weight.

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EXHIBITION & CONFERENCE

6-7 FEBRUARY 2019

PARIS EXPO, PORTE DE VERSAILLES, HALL 7.2

Pharma’s dedicated packaging & drug delivery event INNOVATION

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•Conference •Symposium •Workshops •Learning Lab

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of visitors have already done or anticipate doing business with exhibitors met at the event

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•International Meetings Programme

Exhibitors met an average of

contacts at Pharmapack 2017, of these were new

45%

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INJECTION MOULDING

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These are correlated to seven different second stage velocities starting at 5ccm/s up to 35ccm/s moving in 5ccm/s increments. In figure 1, you will see that the slowest speed is represented in orange. It shows a large droop in the injection pressure profile after transfer has been reached. The reason this occurs is that the cavity is short at transfer, and it takes a period of time before the cavity completely fills and starts to pressurise. The resistance in the cavity is now pushing back on the screw, and the second stage pressure setting is reached and stabilised. As the second stage velocity is increased, you will notice that the droop gets smaller and smaller, and the time it takes to reach the second stage pressure setpoint gets shorter and shorter. In figure 2, part weight is plotted against the second stage speed setting. You will notice that the part weight is continuing to rise until 30ccm/s is reached. You will also notice that at this time any additional second stage speed has no influence on the part weight. This is the sweet spot for where the setting should be set—at a point where the final part weight is no longer influenced by the second stage speed. Remember to think about what is happening to the plastic and to your parts during this time. This is one of the most influential periods of your process for setting dimensions on the part. The slower the speed and response are, the slower you are packing out the parts and allowing the material to cool and solidify. WHAT ABOUT OTHER MACHINES? If you are like most moulders who are scheduling a mould in several different moulding machines, it will be important to understand how each of those machines reacts to the second stage speed setting. Just because 30ccm/s works on machine 4 doesn’t mean that you will get the same response on machine 12. This could be due to different machine makes and models, ages of the machines, hydraulic vs. electric machines, you name it. There are too many things to list that could contribute to the difference. You may also have machines that don’t have an input for second stage velocity. There are many machines out there that don’t. In this case, the molding machine will typically Figure 2: Second Stage Speed vs Part Weight

use the last fill speed input on the machine controller. If that setting is slow, then the second stage velocity will also be slow. OTHER INFLUENCES Besides the second stage speed setting, the size of the fill only part can also contribute to the droop, or slow response. If the fill only part is 60% full at transfer instead of 98% full at transfer, then it will take more time for the cavity to fill out and pressurise. When conducting this study, we want to make sure that the parts are 98% full at transfer to eliminate that as a potential cause in the response. We want to make sure that we are only measuring the inﬂuence of the second stage speed velocity on the process. At the end of the day, we are trying to produce the most repeatable parts in the fastest, most repeatable time, and the second stage speed setting is an often-overlooked inﬂuence on the process. Knowing how your machines respond to this input is one more step toward being better than the next moulder.

At the end of the day, we are trying to produce the most repeatable parts in the fastest, most repeatable time

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SELF-BONDING LIQUID SILICONE RUBBER FOR H E A LT H C A R E

Do you have an adhesion problem? Momentive has a solution. Momentive`s new self-bonding Silopren* LSR 47x9 series can adhere to stubborn substrates where adhesion is normally difficult - such as polycarbonate and PBT and without the need for pretreatments or primers. Feel free to reduce your assembly steps and design complex medical devices with the use of traditionally challenging substrates.

momentive.com/health-care Before purchasing or using any Momentive products, please visit www.momentive.com/salesdisclaimer to view our full product and sales disclaimer. *Silopren is a trademark of Momentive Performance Materials Inc. Momentive and the Momentive logo are trademarks of Momentive Performance Materials Inc.

inventing possibilities

INJECTION MOULDING

www.nolato.com

East meets West SHORTER TIME TO MARKET: US CONTRACT MANUFACTURER PRODUCES HIGH PRECISION SILICONE COMPONENTS FOR IN-VITRO FERTILISATION IN CHINA

o manufacture a medical device specialising in in-vitro fertilisation, a European OEM required a special injection moulding component made of silicone. This needed to be high quality, have precise dimensions, and special surface characteristics. As the component also had to be manufactured within a short timeframe and on a low budget - a volume of 400,000 units - the supplier Polyﬂuor Plastics decided to appoint the Chinese branch of the US contract manufacturer Flexan. The project with Flexan Suzhou progressed swiftly – the plant produced the injection moulding tools within five weeks and provided the first samples just five days later.

“In Europe and the USA, for example in our factory in Chicago, express tool manufacture is of course still possible – but with additional costs,” explained Werner Karau, European commercial leader at Flexan, who is responsible for the project with Polyﬂuor.

“We were appointed by an OEM, to manufacture components for a product for in-vitro fertilisation,” explained Eric Wetzels, managing director of Polyﬂuor Plastics, a Dutch supplier of polymer products. This also includes a special silicone injection moulded part, which is not very complex in itself, but whose manufacture in a cleanroom according to the strict specifications of the customer, posed a challenge. “On the one hand, there were very small tolerances for the dimensions, but on the other hand it is required that its surface feels pleasant and smooth. This requires extensive knowledge, as for example the original material must be injected into the tools and cooled correctly.” Polyﬂuor’s customer initially needed a volume of 400,000 units for this component, but up to 3 million would be a possibility. One advantage of the Chinese branch was time to market.

INJECTION MOULDS FINISHED IN FIVE WEEKS The particularly short delivery time in Suzhou can also be attributed to the fact that the factory has many different injection moulding tools, and therefore has fixed capacity commitments with a large number of qualified tool manufacturers.

“With other manufacturers, it would have taken four to six months until the injection moulding tool had been built,” confirmed Wetzels – Flexan was able to agree a time of two months. The quote from Flexan for production in Suzhou offered the best conditions, for example with regards to tool costs and delivery time. Source: Flexan

“Here, the client has to think carefully, particularly if the same quality can be provided in China.”

“These reserves generally allow us quick tool manufacture,” said Karau. The Chinese branch offers knowledge of high precision medical silicone components and injection moulding tools were able to be completed within five weeks, with the first samples sent to Polyﬂuor around five days later. “Due to our collaboration with Flexan Suzhou, we received our components very quickly, in the correct quality, in a high volume and at a competitive price,” said Wetzels. As a subsidiary of Flexan, the plant in Suzhou combines the cost and capacity advantages of the Chinese site with US company standards. Suzhou also adheres to the quality standards in accordance with ISO9001/13485 and undergoes the audits that inspect this conformity. “The only difference between the American sites and China is that Suzhou is more set up to manufacture many different tools and parts in high quantities, while the US factories specialise in the manufacture of even more complex parts, and services for the end product such as assembly and secondary operations,” added Karau.

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REGULATORY AFFAIRS

Seeking approval MAIK ENDLER, KNOELL GERMANY, EXAMINES THE CHALLENGES FOR START-UPS GAINING MEDICAL DEVICE APPROVAL

utting medical devices onto the market is complex and expensive. This is a particular challenge for small companies and start-ups, whether as a result of global and national regulatory demands, the associated requirements for staff qualification, or the provision of sufficient capital. How can you satisfy these demands without losing sight of the goal of bringing your product idea to the market as quickly as possible? As a consulting business, the Knoell Group has been dealing with these questions for a number of years and has developed methods for addressing them in an efficient and customeroriented manner. Smaller businesses are usually focused on their core competence – generally the development of new and innovative medical device technology. Owing to their lack of experience with regulatory demands, certain points are not taken into consideration sufficiently during development. Normally, prototypes or products almost ready for series production are manufactured without taking medical device approval into account. It is at this juncture that most companies begin to tackle approval issues, and then realise the range of demands is broader than originally assumed. This can lead to delays or the cancellation of the project for lack of profitability. Often a decision is made at the beginning of the project to forgo the assistance of consulting services providers. Few consulting companies can provide comprehensive productoriented advice going beyond the regulatory demands. There is a practical disconnect between regulatory demands and concrete implementation in an actual product. The essential phases of product development together with their core

aspects need to be worked out, and insufficient attention is usually paid to them. There is a lack of the overall view of the procedures that need to be followed to develop a compliant medical device. The main phases are the conceptual planning phase, the specification phase, and the verification and validation phase including clinical assessment, and possibly conducting clinical studies. CONCEPTUAL PLANNING During this phase, customer requirements are determined, the regulatory strategy is defined, and these form the basis for identifying development requirements. Little effort is applied during this phase. Sometimes it is often skipped, although it is in this phase that the scope of all subsequent activities is defined and development strategies may be prepared thanks to the choice of requirements that allow an efficient path through to approval to be taken. Possible variables include the choice of markets for initial approval as well as the product’s specific purpose. Both factors inﬂuence the requirements, the scope of verification and validation, and the product’s time to market. Available capital, which needs to be used efficiently by start-ups, also plays a major role. SPECIFICATION PHASE If sufficient care has been taken with the conceptual planning phase, the specification phase should provide no major challenge. However, inadequate specifications will be defined without the corresponding preparatory work. This includes, for example, the choice of materials. These are usually selected to satisfy technical requirements. However, insufficient consideration may have been given to the biocompatibility of the materials,

which may result in the specifications being revised at a later date, in repeat verifications, and in delays and additional costs. VERIFICATION AND VALIDATION PHASE The verification and validation phase provides supporting evidence. The specifications first need to be verified against regulatory demands (eg performing biological, mechanical and electrical tests), and second, validated against customer requirements. This evidence is generally provided by performing standard tests. However, it is important to ensure that verification activities match the specifications and regulatory requirements. This coherence is generally lacking, resulting in queries and possibly in deviations following assessment by the approval authorities. Validation of customer requirements is usually neglected, which is normally covered by usability validation. Besides development requirements, this is the area that is most often neglected in product development. Companies are insufficiently aware of the significance of fitness for purpose. However, it constitutes the connection between the developed product and the designated application, the intended purpose. Inexperienced companies should look for partners who cover the spectrum of consulting services across all phases of product development. Additional support from a consulting company in coordinating tests and the scientific exchange of information between service providers (testing laboratories, clinical research organization) can create freedom for companies to concentrate on their core competence. All this results in highly efficient, costoptimised approval concepts and significant competitive advantage.

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Five highlights at Pharmapack 2019

The event offers over 411 companies and promises 5,290 attendees

Visiting companies include Johnson & Johnson, Merck and Roche

What visitors said: “The only event with a specific focus on drug packaging.”

The top five visiting countries are: France, Germany, UK, Switzerland and Italy.

Exhibiting companies include Datwyler, Gerresheimer and BD Medical

12:2018 A sign of things to come

research team from Boston University has come up with a self-lubricating condom. It’s hoped that increased uptake could help prevent the spread of sexually transmitted infections. The condom is covered in a special hydrophilic polymer film that upon contact with bodily ﬂuid or water, becomes slippery to the touch. The project was funded by the Bill and Melinda Gates Foundation. The charity had previously issued a challenge for a male contraceptive redesign and the Boston team was one of a number selected to receive funding.

The Foundation launched the redesign initiative after identifying a key reason that people were reluctant to use condoms was largely due to male pleasure. The Boston research team invited a group of 33 male and female volunteers to participate in a study assessing the slipperiness of the condom by touch. A majority of participants (73%) in the research expressed a preference for a condom containing the lubricious coating, agreeing that an inherently slippery condom that remained slippery for a long duration would increase their condom usage.

LOOKING FOR TPE COMPOUNDS? COLORITE MAY HAVE THE ANSWER

olorite will be showcasing Cellene TPE compounds for medical devices at Medica. A line of thermoplastic elastomer (TPE) compounds for medical device applications will be featured by Colorite at Medica (Hall 6, stand H30), between November 12-15. Cellene TPE compounds are suitable for a variety of uses in medical devices, packaging and other regulated markets. Cellene compounds are formulated to be silicone, latex, phthalate, halogen and PVC-free using FDA-compliant raw materials to meet USP Class VI and ISO 10993 standards. Changes in regulations and market conditions are prompting medical device manufacturers to look for solutions via other materials. Colorite says Cellene the TPE compound line is ideal for medical device manufacturers looking for alternatives to PVC, phthalate-plasticised compounds and various rubber materials.

Check out... CorFigo, a startup which has recently launched its first product, Heartpad - a device intended for ablation of cardiac tissue from an epicardial (outer surface of the heart) location, while simultaneously protecting adjacent structures from unintentional ablation injury. The intended result of Heartpad is the efficient ablation of broad areas of cardiac tissue.

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5 THINGS TO CONSIDER

WHEN MANUFACTURING CONNECTED DRUG DELIVERY DEVICES The estimated number of connected drug delivery devices continues to increase and the impact of this trend could be significant, explains Phillips-Medisize

While digital connectivity or connected health can improve the coordination and delivery of patient care, original equipment managers need to keep these five things in mind when creating connected drug delivery devices: 1 2 3 4 5

Development strategy and design consideration Situation analysis and patient compliance Connectivity ecosystem Wireless subsystem Security of device and information

As the Internet of Things continues to become an integral part of people’s lives, the opportunity to use it within drug delivery device applications remains promising. The manufacturers and device designers must identify, investigate and overcome these challenges so that the implementation of wireless and other related smart technologies can be achieved. When done successfully, connected systems enable the patient and caregivers to have a 360° view of both the patient and the disease – not only to manage adherence, but to improve results by understanding the effect of the regimen.