MPN EU Issue 57 by MPN Magazine

EUROPEAN EDITION

MEDICAL PLASTICS + news THE ONGOING WONDER OF SILICONE THE HYBRID MODEL OF MOULDING WHAT TO EXPECT WHEN YOU’RE EXPECTING DURING COVID-19

ULTRASHOT: NEW HEIGHTS OF SPEED, SCALE AND QUALITY Husky Injection Molding Systems’ Sheldon Alexander introduces UltraShot, which enables its customers to scale-up in ways they never knew possible. ISSUE 57

Nov-Dec 2020

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CONTENTS November/ December 2020, Issue 57

Regulars

Features

5 Comment Rob Coker introduces the final edition of 2020.

9 Biocompatibility: Comfortably done DuPont experts Jennifer Gemo and Eugenio Toccalino discuss the ongoing wonder of silicone.

6 Digital spy 12 Cover story Husky Injection Molding Systemsâ&#x20AC;&#x2122; Sheldon Alexander introduces UltraShot, which enables its customers to scale-up in ways they never knew possible.

15 Designing medical devices: Getting personal CEO of Sorrel Medical Dr Andre Yosef on the importance of material selection in wearables.

42 11:2020

19 Sector highlights: COVID-19: Clarified Thomson Screening cofounder Marta Kalas shares her expertise in COVID-19-specific communications plans. 29 Tubing, catheters and stents: Alternative advantages Ross van Royen, Senior Market Manager, Teknor Apex, on why TPEs are a real-world alternative to PVC. 38 Injection moulding: Injection for protection Anatol Sattel, Sumitomo (SHI) Demag, discusses his appointment and injection moulding machinery.

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You expect precision. We deliver. contract manufacturing injection moulding medical devices Our manufacturing includes cleanroom environments, automation, and assembly services, delivering total value solutions that reduce investment and improve cost.

www.carclo-ctp.co.uk +44 208 685 0500 sales@carclo-usa.com United States

• United Kingdom

• Czech Republic • India

• China

editor | rob coker robert.coker@rapidnews.com advertising | sarah livingston sarah.livingston@rapidnews.com head of media sales life sciences & plastics | lisa montgomery head of studio & production | sam hamlyn

Editor’s Comment

graphic designer | matt clarke

ROB COKER

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

2020 – The ride of your life

o say this year has been an emotional rollercoaster would be understating the truth – or at least what passes for truth these days. Someone set the rollercoaster on fire back in the Spring, and later accused someone else of arson. November came bringing ups, downs, twists, turns and loop-deloops, and now all the passengers are looking forward to the ride stopping, getting off, walking past the souvenir photo kiosk, and going for a nice sit down in the garden. But is the world – finally – getting back on track? One reluctant incumbent president and a familiar president elect and all eyes are on America again. In the EU, meanwhile – and not getting similar headlines – the leaders of Poland and Hungary have vetoed the EU’s COVID-19 recovery fund for reasons best known to them. And suddenly vaccines are appearing from numerous sources, which Donald Trump has inevitably claimed credit for. No wonder we’re all feeling a little shaken, sea-sick, and generally fed up.

They’re convinced the vaccines will contain microchips to enforce social distancing, that the EU is commissioned by satanic Marxists, and that the wearing of a face mask is ‘virtue signalling’. I don’t even know what that means. I miss the old way of life, when people remembered that scientific and medical innovations were the reason nobody presented with polio or rickets anymore. When a member of an opposition party was a respected counterpart rather than a separatist usurper bent on further division. And when staying at home was something you did now and then after a busy week of living your life. It’s time to put the grown-ups back in charge. To appoint the relevant and experienced professionals able to certify the safety and efficacy of products. To remove the madness from the arguments. And to get back on-board and just enjoy the ride.

Populism continues to push its alternative realities, too. All of this is pure gold for anti-vaxxers, conspiracy theorists, climate deniers, flat earthers – call them what you will, their messages are powerful. I see the evidence of their arguments in my hometown, coming out of the mouths of people I’ve known all my life.

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DIGITAL SPY

DIGITAL

spy

www.dotz.tech

DOTZ’S MOST SUCCESSFUL QUARTER ON RECORD otz has had its most successful quarter since listing on the ASX, securing three personal protective equipment authentication agreements with a total potential value of approximately $27m (~23m), provided minimum exclusivity sales benchmarks and contingent orders are met. While Dotz is continuously improving its technology to maximise the value of these long-term agreements, the company continues to focus on building sustainable sales activity to reach profitability with its endto-end authentication solutions. Dotz will add its ‘Secured by Dotz’ authentication solution to Breathe

www.parxmaterials.com/technology

ZWIERS CONFIRMS SAFETY COMPLIANCE OF PARX TECHNOLOGY

NEWS UPDATE

REGULATORY UPDATE

wiers Regulatory Consultancy finalised its evaluation of the safety of the Parx Materials technology in medical devices according to the applicable standards (ISO 10993) and Regulation (EC) No 1907/2006. Zwiers Regulatory Consultancy reviewed data on safety aspects (material safety data sheets, and several well-known databases and

biological safety evaluation test results. The outcome was that the starting and reaction materials applied are well-known and can be used to further process as part of a medical device. Parx Materials technology is using medical grade materials which comply with the monographs of international pharmacopoeias (EP/ USP).

Medical’s face mask polybags, boxes and cases to enable verification throughout the supply chain and differentiate Breathe Medical’s ‘Made in Canada’ face masks. Dotz’s taggants may also be inserted directly into the face mask fabric. Dotz Interim CEO Bernie Brookes said: “Our commercial agreement with Breathe Medical is our most significant to date and provides the company with secure, long-term recurring revenue. It also enables us to increase our presence within the USA and Canadian markets, where PPE counterfeiting has significantly increased since the start of the pandemic.”

ACQUISITIONS UPDATE

www.phenion.com

Henkel acquires epiCS Skin Model Technology

enkel closed the acquisition of the skin model technology from SkinInVitro GmbH, effective 2 November. The closing was preceded by an extended and successful technology transfer phase. The epiCS skin models will now be manufactured in the Henkel laboratories in Düsseldorf, Germany, under the Phenion brand. The epiCS technology comprises reconstructed human epidermal equivalents officially approved by the OECD for assessing the skin-corrosive potential (OECD TG 431) and, since April 2019, also the skin-irritating potential of chemicals (OECD TG 439). Henkel’s Dr Dirk Petersohn said: “With this acquisition we are strengthening our existing product portfolio in the field of

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reconstructed human tissue models. With the epiCS technology we can now offer our clients tissue models which are well-suited and regulatory accepted for analysing the skin-corrosive and irritating potential of substances.” Horst W. Fuchs, founder and owner of SkinInVitro GmbH, added: “It is a unique chance for the team to become an integral part of the globally acting Henkel company and to integrate its expertise in respect of the epiCS technology.”

DIGITAL SPY

SERIALISATION UPDATE

www.futuremarketinsights.com/reports/anticounterfeit-cosmetic-packaging-market

RFID gains traction in cosmetic packaging: FMI Study

ccording to a recently published study by ESOMAR-certified market research company, the anticounterfeit cosmetic packaging market is anticipated to reach nearly $50bn (~€42bn) through 2027. As global cosmetic consumption rises, unscrupulous entities are looking to flood the market with counterfeit, duplicate and sub-standard product

talking

POINT

lines. To prevent this, companies are investing in advanced counterfeit and tamper-proof packaging solutions, with special emphasis on multifunctional packaging, widening growth prospects. The global anti-counterfeit packaging market is expected to expand at nearly 9% value CAGR from 2020-2027. These insights are based on a report by Future Market Insights.

www.elesa.com/en/ elesab2bstoreuk

BARRY RATTENBURY, BUSINESS DEVELOPMENT MANAGER, ELESA (UK) LTD Which materials work best for components in a medical application? Elesa’s special technopolymer with silver ion additives works best. These prevent the proliferation of unhealthy organisms by penetrating the surface of the cells and attacking their DNA. Have you seen demand for Elesa’s products increase over the course of 2020? Certainly. Elesa has seen a rise in medical demand due to COVID-19, but there has been a decline seen in many other industries. Elesa is ready to support any industrial sector.

PACKAGING UPDATE

www.kraiburg-tpe.com

KRAIBURG TPE presents new materials solution

rimary packaging for solid and liquid drugs, as well as many other products, will benefit from the latest addition to the THERMOLAST M series from KRAIBURG TPE. The company is also keeping abreast with the times organisationally with its service package that comes with the product to ensure customers are prepared for regulation changes. The materials also meet the requirements of USP661.1 (plastic materials of construction) as well as of USP661.2 (plastics packaging systems for pharmaceutical use). Customers will also benefit from the unique service package for medicalgrade products, which provides

advantages in view of the Medical Device Regulation that will be coming into effect from early summer 2021.

Which trade fairs could we have expected to see Elesa at this year? We were anticipating the attendance of MACH Exhibition, PPMA Exhibition, Southern Manufacturing and Advanced Engineering. Like many industries and sectors, all our exhibitions intended for this year have been rescheduled to the following year. How does Elesa promote its brand in lieu of these events? We’re are doing all we can to imitate the faceto-face, no obligation, technical advice that Elesa is often praised for. We’re providing online consultations, and we’ve teamed up with a handful of media players and campaigns, such as #EngineeringHeroes, dedicated to raising awareness to help with the pandemic. How simple is it for end users to acquire replacement products? Elesa primarily sells to companies that manufacture production equipment and OEM applications, it is rare for Elesa to be involved directly with the end customer. However, as a group operating globally and on an e-commerce platform, it is very easy to source replacement parts. 7

We take service to the next level! ENGEL ensures long-term availability, flexibility and efficiency for your injection moulding production. We support you both on site and online, whenever you need help. You can also benefit from a comprehensive range of training courses that are easily available in person and on the web! Furthermore we offer you our free customer portal e-connect, qualified remote maintenance via e-connect.24 and the monitoring of process-critical components during operation by e-connect.monitor.

engelglobal.com/services

BIOCOMPATIBILITY

Comfortably done FOLLOWING THEIR APPEARANCE IN MPN NORTH AMERICA LAST MONTH, DUPONT’S HEALTHCARE SPECIALISTS JENNIFER GEMO AND EUGENIO TOCCALINO DISCUSS THE BIOCOMPATIBILITY OF SILICONE.

n healthcare, we are all about silicone. Our history is built on the power of silicone technology. It’s our legacy and it will be our future. We strongly believe the raw material selection can strongly influence the design of next-generation materials. If you think of wearables, for example, and the challenge that the industry has for long-term monitoring, which is becoming a growing trend, patches worn in the skin can be quite complex in terms of design and often the raw materials are not selected necessarily at the design stage. So, we like to work with prominent OEMs but we’re increasing our exposure to design houses in order to influence their material selection, because silicone technology can improve the design in terms of the sizes of the patches, complexity of the design, and the wearability of the device.

patient, who could be carrying the silicone around their skin, for many hours – or even days. This is where we find a sweet spot for silicones – it has great purity and biocompatability that other materials jjust don’t have. As an added bonus, it goes very well with electronics. We see a number of projects with silicone increasing because of this new requirement in medical devices – and we see a big potential for it.

Silicone can be very conformable and is adaptive to movement or different skin types. Whether as an elastomer or an adhesive, it is very comfortable and safe for the patient. There are a lot of benefits to the silicone technology that should influence the design of next-generation medical devices, and wearables is a space where we can add great value to existing technologies.

This is where the beauty of our business is: we are 100% focused on healthcare, as mentioned. A lot of our competitors are involved in healthcare applications alongside serving multiple other industries – but we only do healthcare. Our specific business is currently focused on silicones. We carry forward expertise that has been built over 70 years. We follow the legacy of Dow Corning, who started innovating the use of silicone in medical applications in the 50s, so there is a tremendous amount of expertise and knowledge that nobody else can claim. We kept on inventing and innovating and applying this technology. We have a wealth of data, expertise and materials science. And that’s very relevant for today’s stringent regulatory requirements. We really focus on regulatory expertise that we bring to our customers. The product and the chemistry has to be safe by its composition, and our products rely on safe chemistry that is manufactured in a dedicated healthcare site supported by toxicology and biocompatibility data that we share freely with our customers.

Within our business we have a very large engineering polymer and performance resin division. We are leading in PBT, nylon and specialty nylons and a lot of those materials are getting more and more traction in medical devices. The soft part in contact with the skin needs to be built around the electronics. New medical devices have electronics in them, and these need to be protected too in normal applications outside medical. Silicone is a material of choice already used to protect chips, electronics circuits, etc. What we see is the convergence of the needs of the electronic world, where silicone is a strong player, and the needs of the

Some of the challenges for wearables include the development of a longlasting wearable that sticks to your body, does not irritate the skin, and is able to generate data from biosignals in a very accurate and reliable way. With the set of technology that we offer, we are able to help the industry improve a device’s performance while ensuring patient safety.

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WOMEN’S HEALTH

ANGELA SPANG, FOUNDER AND OWNER OF JUNE MEDICAL, AN ORGANISATION THAT PROVIDES MEDICAL DEVICE PRODUCTS TO HEALTHCARE PROFESSIONALS, EXPLAINS THE DEVELOPMENT PROCESS FOR THE GALAXY II SELF-RETAINING RETRACTOR.

A LIGHT BULB MOMENT

RECOGNISING AN OPPORTUNITY Spang was provided with the opportunity to stand behind surgeons during gynaecological procedures. Here, she witnessed how cumbersome and awkward disposable retractors were to use, as well as how expensive they were to buy. That single observation sparked the development of a lighter, cheaper, uncluttered alternative.

It is now being adopted in other fields, such as urology, colorectal, orthopaedics, ENT and paediatrics

LOOKING AND LISTENING Initially, the Galaxy I prototype was launched in 2015 as a lower cost version of existing retractors. The cost savings were attractive to healthcare providers, and feedback from the surgeons was good, but there was still room for improvement. From the perspective of surgeons, it needed to be simpler to use, easier to manoeuvre, and lighter weight - as the National Health Service (NHS) had a target of reducing waste by ten percent. One of the biggest challenges for surgeons was that existing retractors were adjusted using a screw mechanism, which can be difficult to manipulate while holding surgical tools.

WEIGHING UP THE OPTIONS Reusable or single use plastic? Reusable metal retractors are not very lightweight, the sterilisation process is not without environmental concerns, and there will always be a slightly higher infection risk than with a new, guaranteed sterile, product. In the NHS, operating theatre waste is disposed of by incineration, with the cost depending on the weight. The Galaxy II is lightweight, and its emissions are low, but it is still plastic – albeit 10 percent less than other options. However, the cost of disposal and replacement is minimal compared to that of sterilising a tray of surgical instruments. Packaging is a similar consideration, and should be reduced as much as possible, however, for surgical products such as the Galaxy II, where sterility is essential, any risk is unacceptable and so the product must be double bagged.

The redesigned Galaxy II was launched in 2018 and addressed this limitation with cam locks that allow single-handed operation with the flick of a thumb and provide better control of positioning. An attachment was included to hold catheters in place, and the stays were revamped; new hooks were developed, and the elasticity of the cord was increased to enable more tension to be applied without tearing the tissue. Experiments were conducted to measure and understand exactly how much tension could safely be applied during surgery. The new version is lighter weight and uses less plastic too, contributing to the waste reduction targets. Further feedback from a urological surgeon then suggested that additional modification was necessary to allow the retractor to sit correctly to avoid any hindrance when performing surgery alongside a colleague operating laparoscopically. Once the issue was observed first-hand, it was clear that all that was required was to complement the snowman shape design with a square counterpart. MANUFACTURING AND LOGISTICS The first generation new retractor was manufactured outside of the UK, but in a drive to further improve quality, production of the Galaxy II shifted to a specialist medical device developer in England – since acquired by Spang in a strategic move to ensure control of the product – with manufacturing later contracted out to a UK factory as demand rose. Having now launched the product in the US, the long-term plan is to establish a stateside manufacturing base too, eliminating the need to transport plastic to the UK for manufacturing before shipping it across the Atlantic, which is a far more environmentally friendly approach.

SUMMARY What began as a simple observation during a surgical procedure rapidly led to the development of a novel self-retaining plastic retractor that can be operated with one hand. Since its launch in the UK two years ago, where it was initially aimed at the women’s health sector, it is now being adopted in other fields, such as urology, colorectal, orthopaedics, ENT and paediatrics – and now accounts for around a 30 percent market share. More recently, it has been released on the US market.

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COVER STORY

ULTRASHOT: NEW HEIGHTS OF SPEED, SCALE AND QUALITY HUSKY INJECTION MOLDING SYSTEMS’ SHELDON ALEXANDER INTRODUCES ULTRASHOT, WHICH ENABLES ITS CUSTOMERS TO SCALE-UP IN WAYS THEY NEVER KNEW POSSIBLE.

s we approach the end of a challenging year for many industries, Husky Injection Molding Systems is introducing its latest technological innovation, the UltraShot Injection System, which has been designed to enable medical customers to mold parts they haven’t been able to in the past, while offering risk-free scalability and innovative part design.

System experiences fewer high-pressure injection cycles, preserving the original resin properties. This leads to lower molded-in stress and better mechanical and optical properties in the molded part.

Injection molding has not evolved to meet industry demands. Traditional injection molding uses a reciprocating screw, which evolved into a twostage process, where the melting and injection of the resin are separated to give better control and tighter tolerances. Since this two-stage process was introduced, there has been minimal evolution in injection molding – creating limitations in part design and production – until now. The melt delivery system is one of the most critical elements in the injection molding cell when it comes to high cavitation molding. Perfect melt management and cavity filling is so key to final part quality and overall equipment efficiency. With the UltraShot, Husky has moved the shooting pots in proximity of the gate, allowing for greater, highly precise molding control. The UltraShot Injection System pressurizes the resin near the cavities, reducing the influence of resin compressibility and shear, and thermal variations on balance and part quality. Eliminating these influences, the UltraShot Injection System achieves industryleading balance and exceptional part quality. The discrete injection circuit design is scalable to 128 cavities, providing the same process conditions regardless of mold size. Elimination of the scaling effects leads to faster qualification time from pilot to product tooling while reducing risk. Compared to conventional hot runners, melt in the UltraShot Injection

DEMANDING BETTER This year, demand for rapid market entry has increased exponentially, and Husky responded by finding – through extensive new market needs and customer research – that global footprint and manufacturing capability is no longer enough.

This is truly revolutionary for the medical market due to a number of key, highly applicable advantages, including the ability to increase scale faster with lower risk, helping customers go to market quicker; increasing yield by reducing scrap rates; eliminating subsequent manufacturing steps; and enabling new part designs and new resins usage – parts can be manufactured based on function not injection molding limitations.

Now manufacturers need technology to allow for scalability enablement. The UltraShot does this through accurate systemic control. Scaling needs to be done carefully and precisely to ensure it is risk-free and economical. With the UltraShot, molders can effectively grow volume in an economical and timely manner while also greatly decreasing the time-to-market process. In the past, due to risk limitations, medical molders would not go directly to the desired, most economical mold cavitation but often increase in multiple intermediate steps. Each step would have to be validated anytime they increase cavitation. This is not a quick process and can often take years to do successfully, plus it is very expensive requiring more equipment and a larger footprint. With today’s market needs, medical molders need to be able to scale-up their capacity quickly, so they can get their product to market. With system level expertise, Husky can help customers leap to the next level of highly efficient production. Husky’s system-level approach team helps to identify the overall production opportunities, develop the suitable solution and then continues to support the process through advanced connectivity tools. The UltraShot can go from a prototype tool directly to a high cavitation system since the system behaviour is identical, regardless of the number of cavities. A big statement, but one that Husky has demonstrated with actions and innovations, as has its customers – with actual production results. One of its global customers, Coloplast, which specialises in the fields of ostomy care, continence care, wound and skin care, and interventional urology, were offered the opportunity to look into the Husky product development process. This led to massive amounts of confidence in their products. Principle Process Engineer at Coloplast Teo Guldbæk said: “Working with Husky is always a pleasure. I’ve been working with

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COVER STORY

Husky since 1993 and it’s always been rewarding. We have found that developing new products for future needs, which before UltraShot we thought was impossible, can be done. The downstream savings are immense, and working with Husky in this UltraShot project is giving us a lot extra. It has given us a real, strong belief in the ideas and how Husky actually works. And it’s been a pleasure.” INNOVATING SAFELY Technology innovation must be connected to two things in the medical industry – Production Advancements and Risk Reduction. We have all witnessed exponential increases in demand driven by COVID-19. When molding medical parts, risk is a major factor in decisions as it directly translates to cost. For example, there have been scenarios wherein huge volumes of parts have had to be scrapped because of risk to human health. How can industry players reduce this risk and eliminate these scenarios? This is where innovation plays a key role. By ensuring parts are more consistent dimensionally, with perfect balance and by having a more stable process. Plus, connecting innovation with risk reduction, the UltraShot offers repeatability with pressure monitoring and traceability, so any issues are traceable and caught in real time. This virtually eliminates the ‘high-risk’ scenario. Medical companies often invest large amounts of money on part quality verification tools that offer post-mold measurements because their system is unable to sense whether parts are good or bad. With the UltraShot, the need for these expensive measurement tools can be eliminated. The UltraShot enables molders to design for part function instead of being limited by process capabilities, which leads to a higher quality and finer products. The assembly of medical parts has always been a risk for patients, meaning risk for scrap if the parts produced are unsuitable. Now product designs can be further optimized for function enabling a new quality and safety standard. With the UltraShot technology, this risk is eliminated. Transforming the ways in which injection molding machinery performs required novel research and development methods. Husky therefore took a holistic look at the injection molding process, and especially at where the deficiencies were located. For the development of the UltraShot, these requirements had to be addressed head-on in order to develop a product that didn’t just advance injection molding processes, but a product that addresses market needs and deficiencies. With this product, Husky continues to show that it is well connected to the needs of its customers. CONNECTIVITY It also comes down to connectivity and smart manufacturing. The idea of connecting all equipment together to gather useful information, upon which manufacturers make decisions and recommendations, is key. Real-time process monitoring is so important and leads to better overall processes. With the UltraShot, Husky has combined multiple different control technologies into a single unit, taking monitoring information from the mold itself. This has enabled the company to make process adjustment decisions extremely quickly – far faster than in a typical molding cell. It is a fully closed loop communication process

that includes remote monitoring to remotely log into these systems in facilities all over the world, and therefore provide ultimate support with direct access. This is another trend that has grown in unforeseen ways during the COVID-19 pandemic. With limited traveling ability, Husky’s engineers can act on information in real time. This holistic, full mold control solution reduces process risk significantly. CONCLUSION The melt delivery system is critical to the injection molding cell performance. With Ultrashot, Husky masters the delivery of plastic in a way that increases part design flexibility, while reducing risk and improving part quality and speed of mold qualification. It is the perfect fit for medical part producers looking to scale-up, implement more efficient process control, address competitive marketplaces, as well as reduce scrap, waste and cost.

We wanted to develop a product that didn’t just advance injection molding processes, but a product that actually addresses market needs and deficiencies in scalability and part design freedom

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DESIGNING MEDICAL DEVICES

Getting personal CEO OF SORREL MEDICAL DR ANDRE YOSEF ON THE IMPORTANCE OF MATERIAL SELECTION AND CO-OPERATION IN WEARABLE MEDICAL DEVICES.

HOW VITAL HAS PERSONALISED MEDICINE BECOME AND WHAT HAS SORREL MEDICAL DEVELOPED TO CONTRIBUTE? An understanding of personalised medicine is crucial, as different patients living with the same disease may have varying treatment responses. This is due, in part, to the fact that one disease type may manifest in a variety of forms. Personalised medicine, therefore, allows for patients to receive access to more effective and targeted treatments. Sorrel is facilitating this through the development of a wearable drug delivery platform that further enhances patient adherence to treatment by encouraging a positive self-administration experience. This is achieved through the device functionality which caters to varying patient populations, use environments and adhesion sites. This allows us to adapt the wearable technology to fully suit the specific needs of each user. The highly customisable and software-based platform enables physicians to easily tailor treatment protocols for each patient. Drug delivery parameters can accordingly be adjusted to individual prescriptions, utilising the software-based treatment feature of the Sorrel platform. WHAT ARE THE USPS OF THE DEVICE(S)? The Sorrel wearable platform solution provides a simple and efficient means of drug administration, particularly for large volume and high viscosity medications. Being primary container agnostic, Sorrel devices can accommodate a variety of drug reservoirs (vial and cartridge-based), ranging in size from 1-30mL. This enables Sorrel to partner with a range of pharmaceutical players for different drug types, while the utilisation of primary containers prevents disruption to the development pipeline. Sorrel devices can arrive at the patient pre-filled and pre-loaded with medication, reducing the number of steps necessary for them to selfadminister and mitigating the risk of errors, thus improving the user experience, and encouraging adherence to treatment. The electromechanical pumping mechanism utilises proven technologies for highly reliable and controlled drug delivery. Connectivity to Bluetooth and near-field communication (NFC) platforms enables patients to share treatment information with caregivers, healthcare providers, and other necessary stakeholders. The patient-centricity of the Sorrel solution has been further verified through extensive human factors testing. WHICH MATERIALS WERE SELECTED FOR MANUFACTURING PROCESSES AND WHY? The device shells are comprised of plastic polymer, while all needles used in Sorrel devices are constructed from biocompatible stainless steel. The body sticker materials, which adhere devices directly to the skin, are similarly medical grade and industry accepted and proven. The sticker materials must be suitable for long-term wear while also being biocompatible, noncytotoxic, non-irritating or sensitizing. Sorrel complies with a variety of medical device standards, guidelines and regulations pertaining to the quality and safety of materials chosen for the Sorrel wearable drug delivery devices. In addition, device materials are selected to ensure they do not

possess any chemicals which may prove to be harmful to end users, caregivers, or anyone handling the device throughout the product journey. WHICH INDUSTRY PARTNERS WERE INVOLVED IN DESIGN, DEVELOPMENT AND MANUFACTURE? Spun out of the established Israelbased medical device leader Q Core Medical, and under the leadership of the Eitan Group, Sorrel leverages the groupâ&#x20AC;&#x2122;s considerable operational wingspan and its proven experience to bring to marked advanced wearable drug delivery devices. Our main industry partners include pharmaceutical companies, for which we provide the device constituent of a combination product. Our pharmaceutical partners work closely with the Sorrel team throughout the device development process, on definition of the product, regulatory strategy, human factors testing, system verification and validation, and more. In addition, Sorrel works with a range of leading internationally recognised suppliers to ensure highest quality of device components, as well as with world renown testing labs, primary container manufacturers, and consultants when required. However, all innovation, R&D and final assembly of Sorrel wearable drug delivery devices is conducted in-house.

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26/10/2020 14:10:24

DESIGNING MEDICAL DEVICES

A RANGE OF BENEFITS TODD MCDONALD, DIRECTOR OF SALES AND MARKETING AT TEQ, USES HIS DESIGN AND ENGINEERING EXPERTISE TO EXPLAIN THE BENEFITS OF THERMOFORMED MEDICAL PACKAGING.

ith many ways to package a medical device, it may be hard to decide which route to take. TEQ, which has established itself as a global presence offering total packaging solutions, asserts that packaging a medical device by thermoforming offers a range of advantages. Established in 1979, TEQ has more than four decades experience in the design and manufacture of innovative thermoformed packaging, and believes the benefits of thermoforming include product orientation, handling assurance, clarity, consistent opening experience, additional protection, and ergonomics. PRODUCT ORIENTATION A nurse may need to quickly confirm a product’s orientation and how to grab it. With a thermoformed tray, a nurse can be sure that the medical device stays securely in place in the intended location so they can remove it swiftly and confidently. HANDLING ASSURANCE To ensure a device doesn’t compromise sterility, a nurse needs to control the movement of a device as its package is opened. A thermoformed package is more likely to ensure there is no unnecessary rotation or accidental removal. CLARITY A nurse can find it beneficial to see and identify the product clearly so they can better present the device or see any potential defects. CONSISTENT OPENING EXPERIENCE Incorporating a good peal area in the package design can allow a nurse an easy access point for pealing the lidding back from the package. ADDITIONAL PROTECTION With rigid plastic, a medical device is protected in sensitive device areas. For example, a package can be designed so a syringe will not get depressed. MORE ERGONOMIC A pouch can require both wrists to twist to open, putting repetitive strain on both of the nurse’s wrists. With a sealed thermoformed tray, only one hand is opening the seal while the other is holding the tray in place. TEQ develops products for a range of markets, including consumer, component handling and medical from its ISO- and BRC-certified production facilities in the UK and central Europe. This includes state-ofthe-art cleanroom facilities. As well as rigid plastic solutions, the company develops custom designed moulded-fibre packaging with a paper smooth surface from natural and sustainable fibre. Through its US-based sister company, the company also has significant expertise in both medical device manufacturing and pharmaceutical and sterile medical packaging. The company is part of the NYSE-listed Sonoco, a global packaging solutions leader, ranked 48th in Barron’s 100 Most Sustainable Companies for 2019. TEQ has design and manufacturing facilities in the UK, central Europe and the United States. This offers customers a truly global

supply opportunity, with critical projects transitioned to more local manufacturing locations across the world. With both the US and European manufacturing facilities having identical machinery, tooling manufacture, and impeccable quality standards, multinational customers can benefit from a single validation process, logistical advantages, exacting quality, repeatability and uniformity. The multiple locations can also shorten lead times for clients. Nottingham is the manufacturing facility for the UK and Northern Europe. The manufacturing site in Poznan, Poland, serves central and eastern Europe. Meanwhile, TEQ in the US has manufacturing sites in Huntley, Illinois, and Fremont, Indiana. TEQ’s production facilities are certified to ISO 13485:2016 and BRC/IOP Global standard for food packaging and other packaging materials. The company also adheres to FSC Chain of Custody requirements for sustainability. Across its European business, there are 16 plastic thermoforming machines capable of punch and die and pressure forming, plus six in-line pulp thermoforming machines. The Nottingham factory incorporates a state-of-the-art cleanroom for the production of custom thermoformed medical packaging. The Poznan facility incorporates thermoformed plastic manufacture and a separate dedicated area for the manufacture of dry pressed fibre. There is also a 2,600-pallet capacity warehouse for storing materials and finished products before they are shipped.

With a thermoformed tray, a nurse can be sure that the medical device stays securely in place

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SECTOR HIGHLIGHTS

: Clarified THOMSON SCREENING CO-FOUNDER MARTA KALAS SHARES HER EXPERTISE IN CREATING AN EFFICIENT COVID-19-SPECIFIC COMMUNICATIONS PLAN.

n the medical plastics industry, you will be well aware of the impact of Covid-19. Like Brexit, it is not just affecting your bottom line, but also the day-to-day running of your business and the amount of work needed to ensure compliance with ever-changing regulations and guidelines.

from three different perspectives to cater to three different needs. The key to getting this right is understanding your audience and you can do this by listening actively.

The easiest way to deal with this is to create a package of tools that will help you stay on top of the changes, and the ever-increasing regulation and actions you need to take. For example, Thomson Screening has developed a toolkit to help managers work through what’s needed and how to action it. The toolkit provides training and sample documentation. The good news is, none of these activities is new; businesses do them all the time. What’s different is that now businesses need a specific ‘Covid flavoured’ version.

LISTEN ACTIVELY TO THE GROUPS WITHIN YOUR AUDIENCE You need to listen and hear what your audience or different groups in the audience (whether internal or external to the business) are most concerned about. For example, is it rules around social distancing? or mask wearing? In the healthcare sector, many will be well informed, but you need to cater for everyone.

A good communications plan will be the cornerstone of your successful ongoing management under Covid-19. Let’s start with the basics. Any communications plan needs to include the following characteristics: • • • • •

Understanding your audience; Listening actively; Being clear about what you want to say (simply); Using the appropriate channel(s); and Making sure your communication is timely.

Before we take each of these values in turn and work through how they need to be adapted, let’s add one step, at the very beginning: know your trusted sources of information. The best sites to visit are the most important government websites. These are the first places you will need to check regularly. One of the difficulties at the moment is that there is so much conflicting, confusing or out of date information circulating. Go straight to the horse’s mouth, check the government websites first. Now, let’s take a look at each step and how it needs to be adapted for Covid-19: UNDERSTANDING YOUR AUDIENCE Under the current circumstances your audience will be much more sensitive to different types of communication, and this will not necessarily be along the lines you may expect. Essentially, we are talking about people’s ability to handle uncertainty and manage risk, and this has nothing to do with their job, their level of education or even their age. Whether they are staff members, customers or suppliers, etc. some people will be very risk averse, some will rely on science or authority, and some will be just the opposite. Your communications plan needs to be mindful of this and cater to the different needs of your audience. It may need you to say the same thing

You also need to show the audience that you are there, that you are listening, that the measures you are putting in place are to protect them and meet their needs. The actions you take need to be about them – and they need to understand that in your communications. Just acting, but not communicating, can lead to misunderstandings and a break-down in trust. BE CLEAR You don’t want people to come to work if they have symptoms – so be clear about this and what they should do in this situation. For example, if in doubt, stay home and phone or contact your manager. You also need to ensure that everyone has all the contact details they will need if they are at home and can’t come to the office. If you need customers or other visitors to wear a mask at all times, or if they only need to wear them in certain areas – be clear about this. If areas

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SECTOR HIGHLIGHTS

within your place of business are off limits to external visitors, ensure they are obviously labelled. Above all, your communications need to be clear, simple and, if necessary, repetitive. Just look at how the UK NHS is using simple words and lists of no more than three or four items. Don’t assume just because you’ve said it once, everyone has heard it or taken it on-board. Avoid using abbreviations or acronyms. And remember, this is not a time to be original or funny. Finally, it really helps to give some specific examples and little personal touches: show that you have considered the needs of disabled staff and customers, or perhaps those who rely on lip-reading. DECIDE ON THE BEST COMMUNICATIONS CHANNELS These days there are dozens of communications channels from your intranet to your website, from Twitter to WhatsApp, from newsletters to window signage. Choose the right platforms for the audience and for the message. Make use of as many channels as you can and be consistent with your messages. Normally you’d be using a slightly different approach in each channel, but in your Covid-19 related communications, it is really important that there is no misunderstanding. Start by creating a list of all possible channels: website, newsletter, sign on the door, customer service team, training materials, Twitter feed, LinkedIn post, everything you can think of. Use templates as much as possible as this will save time and keep the communications consistent. Ensure anyone involved in any form of comms (from PR to social media, from web editor, to marketing flyers, from poster designs to advertising) know what your Covid-19 messaging is and when and how to include it. ENSURE TIMELY COMMUNICATION This is where Covid-19-related communications get really tricky: things change very fast (or they may stay the same), which makes it very difficult to plan. You want to make sure you have not left out-of-date information on any of your communications, and you want to be sure you are always in line with the most recent government or Public Health guidelines. Yet, you cannot spend every hour, every day, checking and updating everything.

Once you’ve set everything up, it’s simple to set a weekly system to confirm that either everything Covid19-related is still correct and relevant, or if there are changes that need to be communicated right away. Marta Kalas is co-founder of Thomson Screening, developers of the Thomson Covid-19 Test Manager software platform that enables testing providers to scale irrespective of where, how and what test is carried out. Thomson Covid-19 Test Manager is designed to adapt rapidly to fast-changing requirements and is fully scalable. The Innovate UK grant enables Thomson Screening to utilise investments made in the core functionality of the company’s products used in the NHS, especially its SchoolScreener Imms product, to rapidly repurpose and deploy the software. Sources: • https://www.gov.uk/coronavirus • https://www.gov.uk/guidance/nhs-test-andtrace-how-it-works#people-who-developsymptoms-of-coronavirus • Ethnicity and mortality rates up to 15 May 2020 in England and Wales: https://www. ons.gov.uk/peoplepopulationandcommunity/ birthsdeathsandmarriages/deaths/articles/ coronaviruscovid19relateddeathsbyethnic groupenglandandwales /2march2020 to15may2020

Fortunately, there are a couple of tricks and tips you can use. These are not new, they should be familiar to you, and in Covid-19-related messaging they are essential: •

• • •

In electronic communications (websites, newsletters, chats, etc.) use links directly to the relevant government websites (see list above); Used shared file systems (e.g. Google Drive, One Drive or Dropbox) for templates and drafts; Have a log of where these templates are used, to make sure you don’t miss one of them; and It is an extra few minutes to get everything in one place when you start, but it will pay dividends many times over when you suddenly need to change something.

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3D PRINTING

THROUGH SELECTIVE LASER SINTERING AND WINDFORM FX BLACK POLYAMIDE-BASED MATERIAL, CRP TECHNOLOGY HAS RAPIDLY MANUFACTURED THE VISOR FRAME OF PPE FOR MEDICS AND PROFESSIONALS.

On form T

ecnoguarnizioni s.a.s has been producing customised industrial flat gaskets of all sizes based on the customer’s design for over 40 years, and is now actively contributing to the fight against COVID-19 by creating new personal protective equipment.

them to the longitudinal traction test and, with regards to the side holes, to compression tests by manual tightening of screws and nuts.

Tecnoguarnizioni’s project consisted in the creation of two polycarbonate protective face shield models: the Safe4U model for working environments, and the Safe4U+ model to acquire the CE Mark for medical devices.

To quote Tecnoguarnizioni CEO, Sandro Righi: “Both PPEs are equipped with an elastic band. Its length and tension are variable by means of two buckles placed at the end of the visor frame. Two siding knobs act as fixing mechanisms and allow the adjustment of the orientation hardness of the shield when rotated upwards. The face shield resists to lifting from involuntary gestures, but at the same time the shield can be lifted easily, with a maximum angle of 180 degrees. The Windform FX BLACK visors have fully satisfied our requests and needs.

Both are equipped with a visor frame that enables the wearer to function hands-free. Tecnoguarnizioni thus turned to CRP Technology and its technological solutions to manufacture the visor frame. Based in Soliera, Modena, Italy, Tecnoguarnizioni needed the functional prototypes quickly in order to submit the final device to the CE certification process, as well as to finalise the injection mould for industrial production in order to avoid wasting time and money. The Safe4U model is best described as a personal eye and face protector, holed visor frame with adjustable and transparent shield. It protects against high-speed particles at medium energy impact (i.e. 120 m/s). With a flip-up, replaceable shield and easily adjustable elastic band, Safe4U+ is also a personal eye and face protector, but with a bigger, replaceable, flip-up shield and visor frame without the holes. It is a CE-certified model for use in healthcare settings, medical facilities and hospitals as it is suitable for the mandatory requirement of protection against drops and splashes of liquids. The Safe4U+ also protects against high-speed particles and low energy impact (i.e. 45 m/s).

“A certifying body tested the face shield to evaluate the quality … again, the visor proved to be capable, and the tests were brilliantly passed. We are very satisfied with the results obtained. Thanks to CRP Technology and its AM solution, we have achieved speed of execution, remarkable precision, and lightweight flexibility.”

Both protective face shields comply with the specific requirements provided by the harmonised standard EN 166:2001 as PPE Category 2, Optical class 1. They can be easily disinfected/sterilised and reused. SELECTION AND SATISFACTION The examination of the 2D and 3D files of the visor frames led CRP Technology’s 3D Printing Department to identify Selective Laser Sintering as the most suitable process, and Windform FX Black, a new generation polyamide-based material with a dark black colour from the Windform TOP-LINE range, as the most suitable material. Windform FX BLACK is characterised by exceptional resistance to repeated bending and torsion, and shows excellent impact resistance even at low temperatures. Once manufacturing was completed, the visor frames were hand-finished by CRP Technology’s specialist team to simulate the finish of an injection moulded part. This was possible due to the characteristics of Windform FX BLACK, which has a consistency and behaviour similar to those of polypropylene and ABS injection moulded parts. After shipment, the 3D printed visor frames were attached to the transparent polycarbonate shields. Tecnoguarnizioni then subjected

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Catheter WORK WITH THE EXPERTS

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COUNTERFEITING AND SERIALISATION

W E W I L L L OC K Y O U TALISMAN’S MANAGING DIRECTOR, SHAUN CHAMPION, SHARES WHAT’S NEW WITH INJECTION MOULDED TOTE AND BAG SECURITY LOCKS.

alisman Plastics unveiled the next iteration of the popular Boxloc security seal earlier this year, with the product now featuring updated colours, customisation and differing pack sizes.

The new model, the BL02, follows on from the BL01, which is principally used to secure tote boxes, providing effective traceability. It is easily identifiable with sequential serial numbers or barcodes, and more than 30 million Taliloc clinical waste bag ties, as well as more than 10 million Boxloc security seals, have been produced so far in 2020 alone. Furthermore, the recent acquisition of the Keyence laser marker has equipped Talisman with the capabilities of increased customisation across its entire product range. Medical Plastics News spoke to Talisman’s Managing Director, Shaun Champion, to find out more. HOW DO TALISMAN’S PRODUCTS CONTRIBUTE TO SAFETY AND SECURITY IN THE MEDICAL INDUSTRY? Our Taliloc product, for example, is primarily used to secure clinical waste bags. We supply 50 per cent of NHS trusts across the UK and have produced an estimated 32 million of our clinical waste ties over the last year. They’re a key part of hospital inventories. Without them, consigning clinical waste just isn’t possible. With Boxloc, it clearly and quickly shows if the box it is fitted to has been tampered with, ensuring longer-term security of tote boxes.

WHAT HAPPENS TO THE PRODUCT ONCE IT HAS BEEN REMOVED? IS IT REUSABLE? RECYCLABLE? Boxloc, Taliloc, and all our security seals, are fully recyclable. As a plastics company we’re more aware of the need to protect the environment and we’ve developed a security seal that is made entirely from recycled plastic, with plans under way for a biodegradable product. HOW DIFFICULT A PROCESS IS TRANSCRIBING SERIAL NUMBERS ON TO THESE PRODUCTS? Using our new Keyence hybrid laser marker, we can transcribe barcodes, QR codes, logos, serial numbers and text onto our products. It’s an easy process, and our staff are trained on the design system which takes the artwork and automatically plots the path of the laser which prints the seal with pinpoint accuracy without burning the plastic.

WHAT DO THE VARIOUS COLOURS OF THE BOXLOC SIGNIFY? Our ability to produce Boxloc, and the range of our security seal products in various colours, mean that our customers can align the product to their brand. HOW IMPORTANT IS IT FOR YOUR END-USERS TO KNOW THEIR PRODUCTS ARE SAFE FROM COUNTERFEITING, ETC? Boxloc’s tamper-evident nature will quickly show the end user if any goods have been damaged in transit or tampered with. With the auditable trail generated by the printing of serial numbers and barcodes, it’s much easier for customers to track their goods and ensure product security for the duration of its journey.

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TUBING, CATHETERS AND STENTS

JOE ROWAN, PRESIDENT AND CEO OF JUNKOSHA USA AND EUROPE, DISCUSSES THE COMPANY’S ABILITY TO CONTINUE TO ENABLE TECHNOLOGY INNOVATORS WITH A NEW PEELABLE HEAT SHRINK TUBING (PHST) SOLUTION.

AT THE CUTTING EDGE M

aterials specialist and pioneer of fluorinated ethylene propylene (FEP) PHST, Junkosha, has recently launched its newest innovation, Cut-To-Length and Slit PHST, to enable a wide range of catheter-based procedures where flexibility is key. As part of our ambitions to be at the forefront of precision-engineered, miniaturised micro catheters and guide wires, we are leading the charge towards heat shrink solutions that provide the flexibility needed to complete increasingly complicated treatments. Today’s catheter delivery systems for neurovascular treatments rely on increasingly complex shapes, constructs, and polymers. This intricacy in catheter bonding and welding applications can only be consistently achieved through advanced technology and proper application of sound engineering principles. With our Cut-To-Length and Slit PHST solution, we are enabling catheter manufacturers to use different lengths to reflow a catheter’s baseline materials, and to attach complex shapes and constructions – enabling challenging procedures to be completed efficiently. Typically, neurovascular catheters are used to deliver various devices to the brain and feature in numerous cranial procedures. Innovation in the treatment of ischaemic stroke with new technology such as stent retrievers and flow diverting stents will drive an increase in the number and type of catheters required. This brings the need for shorter PHST solutions. Just like longer forms of PHST, Cut-To-Length and Slit enables the catheter manufacturer to use a shortened length to reflow the materials, and bond, tip and weld the complex shapes, sections and segments needed. Cut-To-Length and Slit PHST is in demand due to the increased availability of custom-engineered diagnostic interventional catheters, which are designed for tougher internal procedures. This solution can be cut to a specific size for a given requirement. The Cut-To-Length and Slit option incorporates a peeling slit which enables faster throughput during manufacture, thus improving cost savings. Key application areas include balloon mounting, catheter lamination, forming, tacking, masking, bonding parallel tubes and polymer jacket compression. WIDER PHST PRODUCTS Junkosha has a deep heritage in material science and fluoropolymers. Our solutions are at the leading edge of what is possible, and our wider PHST solutions are ideal for very small devices such as micro-catheters. Conventional skiving techniques do not work on smaller reflowed catheters, frequently leading to bending or kinking, and therefore rendering them useless. Miniaturisation is picking up pace, with manufacturers demanding catheter solutions that readily penetrate hard-to-reach places.

This covers a wide spectrum of applications, including neurovascular delivery of devices such as coils and stents for stroke or aneurysm therapies, and even signals/energy to help support neuromodulation or neurostimulation in Parkinson’s. Innovations in this area include Junkosha’s ultra-small PHST – a tubing solution suited for laminated jacket coating of tiny guide wires (down to 0.011” and 0.014”), leveraging the fact that PHST has a recovered ID down to 0.009”. These miniature guide wires are perfect for applications including the navigation of vessels to reach a lesion or vessel segment within, for example, the brain or heart. New innovations continue to push the boundaries of the medtech sector. One example is Junkosha’s 2.5:1 PHST solution, which has been designed to equip catheter manufacturers with the highest shrink ratio currently possible in peelable FEP. This solution enables the use of cost-effective, lower tolerance, baseline materials in the manufacturing process, and the ability to reflow these easily into a single smooth construct. This results in a reduced total cost of ownership for the catheter manufacturer, which in turn increases the margin. FUTURE TRENDS I expect the need for more complex procedures to continue to increase as the healthcare system maintains its drive towards minimally invasive procedures. One of the biggest challenges is to continue innovating at the best price. With the push for smaller procedures increasing, it is a critical requirement for tubing manufacturers to enable catheters to complete these tasks efficiently and cost-effectively. This challenge can only be overcome through one thing – innovation.

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TUBING, CATHETERS AND STENTS

ALTERNATIVE ADVANTAGES ROSS VAN ROYEN, SENIOR MARKET MANAGER, TEKNOR APEX COMPANY, ON WHY TPES ARE A REAL-WORLD ALTERNATIVE TO PVC IN MEDICAL TUBING.

ow in commercial use by device manufacturers, medical-grade TPEs have emerged as the first practical alternative to PVC in tubing. This article presents information on how these TPEs compare with PVC in every phase of manufacture and end use typical for tubing, from extrusion to everyday handling by healthcare workers. It emphasises ‘real-world’ requirements not typically considered in a product data sheet. PVC has long been the material of choice for tubing, and Teknor Apex is well established as a supplier of PVC tubing compounds. Earlier generations of TPEs proposed as alternatives to PVC failed to duplicate the advantages of PVC in tubing applications. To develop TPEs that overcome these limitations and exhibit certain advantages over PVC, researchers in the TPE Division of Teknor Apex worked with medical experts in the Vinyl Division, along with tubing manufacturers and medical-device OEMs. Their work led to the development and commercial use of medical TPEs under the brand name Medalist. FLEXIBILITY, CLARITY, STERILIZATION RESISTANCE Flexibility is one of three functional properties that are fundamental in medical tubing. In PVC compounds this property is the result of high levels of plasticizer – as much as one-third of the formulation by weight. The inherent elasticity of TPEs, on the other hand, renders the use of plasticizer unnecessary. Another basic functional property is clarity, which is essential for medical staff to assess flow, bubble appearance, and the condition of a fluid as evidenced by its colour. TPEs can offer the same crystal clarity as PVC. The capacity to withstand even the most aggressive methods of sterilization is a third basic requirement for tubing. In tests for colour shift following heat ageing of gamma irradiated samples, TPEs have proved markedly superior to PVC. Gamma exposure causes degradation of the PVC polymer, resulting in discolouration, embrittlement, and a fall-off in mechanical properties. Compounders like Teknor Apex have developed gamma-stable grades of PVC that exhibit reduced levels of such deterioration, but the Medalist compounds surpass even these in gamma-resistance, with heat-aged colour shift values less than a third those of the PVC. TPE compounds provide these basic functional properties while exhibiting values comparable to PVC for mechanical properties critical in tubing, such as tensile strength and tensile modulus. Their specific gravity is 25 per cent lower, indicating that a pound of TPE compound yields more linear feet of tubing than a pound of PVC. EVERYDAY CLINICAL CONSIDERATIONS Among the greatest failings of alternatives to PVC proposed in the past were those involving properties very specific to tubing as employed daily by healthcare workers:

KINK RESISTANCE In many applications, tubing is used for infusion of fluids into the body. If the tube should be bent through a radius that is too tight, it collapses, with consequences that are potentially lifethreatening. This kinking occurs when the compressive forces on the tubing surface inside of the bend exceed the tensile forces on the external bend surface. Changes in wall thickness and hardness or modulus will therefore impact the kink resistance. Teknor Apex used a hand kink test in which the ends of conventionally sized infusion tubing of an appropriate length (7-10cm) were brought together and parallel, shortening the loop formed until kinking occurs, and then measuring the outer diameter of the loop portion of the tubing. A minimum bend diameter of 1.5cm was achieved with the standard Medalist grades. This performance was comparable to that of commercially available PVC tubing. CLAMP RESILIENCE To temporarily halt the flow of liquid, medical tubing is often clamped. After the release of clamping pressure, the tube must recover and allow flow to resume in a short space of time. Medalist samples have proved to be as resilient as, or better than, tubing produced from PVC. NECKING This is a phenomenon in which the diameter of a tube is permanently reduced when exposed to a longitudinal force. While traditional TPEs are prone to necking, PVC shows very little. Teknor Apex has subjected Medalist test samples to a manual and visual assessment and found levels of resistance to necking equivalent to those of commercially available PVC tubing.

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BSI update on the new UKCA and future UK regulation of medical devices and in vitro diagnostics The Medicines and Healthcare products Regulatory Agency (MHRA) published new guidance on GOV.UK, which sets out how medical devices and IVDs will be regulated after the transition period with the EU has ended (from 1 January 2021). The MHRA has noted three key aspects in particular: • BSI will be introducing a new UK route to market and mark of conformity for devices. The UKCA mark is a new UK product marking that will be used for certain goods, including medical devices, being placed on the Great Britain market from 1 January 2021. • BSI will continue to recognise the CE marking until 30 June 2023. Although the UKCA mark will be available for manufacturers to use from 1 January 2021, we will continue to accept CE marked devices until 30 June 2023. This will allow time for the UK route to market to embed and for industry to adapt to these new requirements, ensuring a continued supply of safe devices to UK patients after the transition period. • The EU Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) will not be implemented in Great Britain. These Regulations will fully apply in EU Member States from 26 May 2021 and 26 May 2022 respectively and will not take effect until after the transition period has ended. They will not therefore be retained EU law as described by the EU Withdrawal Agreement Act. The Directive 90/385/EEC on active implantable medical devices, Directive 93/42/EEC on medical devices and Directive 98/79/EC on in vitro diagnostic medical devices will continue to apply in Great Britain from 1 January 2021. BSI was the first Notified Body in the world to achieve full scope designation to the IVDR. The new Regulation brings with it significant changes to the regulatory requirements for IVD medical device manufacturers and introduces a new rule-based classification system with increased Notified Body involvement. The new rule-based system supersedes the current list-based approach in the Directive. This change means that, as classification rules will be applied to all IVD medical devices, up to 90% of IVD medical devices will require a notified body for conformity assessment. Click on the title below to find out more information and to register for live events and previous webinars from our technical experts https://www.bsigroup.com/en-GB/medical-devices/our-services/IVDR-Revision/

BSI have a dedicated ISO 13485 Delivery Team who have adapted to delivering remote QMS audits during the COVID-19 pandemic. Our ISO 13485 Delivery Team has expanded and continues to recruit across Sweden, Germany and France. With full training given to include Lead Auditor Training to ISO 13485:2016, MDSAP and MDR; medical device industry professionals within R&D, Design, or Testing & Maintenance have transferred their knowledge to our Notified Body to help ensure patient safety and device conformance.

Ever considered working for leading Notified Body? We make a difference to the world every day. BSI are always on the look out for medical device experts to join us and make a difference in assessing, healthcare, testing, training and publishing.

For more information on BSI careers visit our careers page or email our Talent Acquisition team- careers@bsigroup.com

TUBING, CATHETERS AND STENTS

HAPTICS Most tubing sets are used manually, with the familiar feel of PVC being the accepted norm in the healthcare industry. To maximize the acceptance of Medalist compounds by the users of these products, the haptics of the finished tube must be as close to the incumbent material as possible. In blind tests of tubing made from PVC and Medalist TPEs, conducted among experienced people in the tubing industry, the products proved to be indistinguishable. PROCESSING: EXTRUSION AND DOWNSTREAM Tubing manufacture involves extrusion and a variety of post-extrusion or downstream processes, often carried out in-line with extrusion. In the commercial extrusion of tubing, Medalist TPEs have achieved highspeed, tight-tolerance production. Downstream considerations include: •

Frost appearance. The processing of TPE tubing can be adjusted to create a frosted surface similar to that of many PVC tubes.

•

utting to length. In high-speed extrusion, Medalist TPE tubing is C easily cut to length in-line with extrusion.

•

ole punching poses no problems, even allowing for tube rotation H producing a serpentine pattern.

•

ipping – the process of forming a tapered closure at the end of T a tube – is carried out without need for pretreatment or release agents, which would require additional regulatory approvals. Cycles are fast, there is no sticking, tapers are consistent, and the aesthetic quality of the finished product is excellent.

•

Printing is carried out using standard automated corona surface treatment and traditional pad printing with conventional inks.

•

Insert moulding, in which luers are applied to the ends of tubing, involve short cycle times, no tube distortion, and excellent bonding of the tubing to pre-coloured luers made either of polypropylene or Medalist elastomers.

BONDING TO STANDARD POLAR CONNECTORS This has been one of the more challenging hurdles to overcome, due to the solvent-resistant nature of the Medalist chemistry, the non-wetting surface characteristics, and the significant improvement in elongation or stretch during retention testing. With the cyclohexanone solvent commonly used with PVC, the Medalist tubing does not achieve the same level of retention as that of PVC, but it may achieve sufficient bondability, depending on tube dimension and criteria. Commercially available adhesive systems provide strong adhesion but typically do not permit sufficient work time for ease of assembly.

Teknor Apex has overcome these limitations for TPE tubing in the 65 to 85 Shore A range with development of these bonding systems: •

Room temperature-cured adhesive. This system is designed for slow setting to allow precise control of assembly. Bonds exhibit cohesive rather than adhesive failure, an indication of the high level of bond strength achieved.

•

Light-cured adhesive. This system exhibits a higher retention force than is achieved with any commercially available light-cured adhesive.

In addition, Teknor Apex scientists have demonstrated equally acceptable retention values using tapered barbs, thereby eliminating the need for solvents or adhesives. The elastic performance of the Medalist compounds allows for a tight fit onto the male connector barbs.

The inherent elasticity of TPEs renders the use of plasticizer unnecessary

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COMPONENTS AND ASSEMBLY

THE HYBRID MODEL OF MOULDING VICE PRESIDENT OF BUSINESS DEVELOPMENT AT INJECTECH DAVE SPLETT PROVIDES A GUIDE TO FINDING THE MOULDING COMPANY THAT WILL HELP YOUR BUSINESS FIND SUCCESS.

inding the right company to assist in the development of your next plastic component should appear to be a simple process. However, when pressured by capital expenditures, a need to drive costs lower, and tight deadlines, many medical OEMs and their employees soon realise the potential for this simple process to become expensive and time consuming. With thousands of moulding companies worldwide, there will be anomalies found with specific companies. It is important to understand the ‘general’ practices involved with a hybrid business model and the discernment between the two commonly found types of moulding companies to facilitate strong decision making. CUSTOM MOULDERS The relationship between a custom moulder and an OEM is purely transactional. The custom moulder can best be defined as a contractor, whilst the OEM will pay for the mould base outright, the custom moulder will manufacture parts. This relationship is advantageous to the OEM. If the custom moulder doesn’t perform against the OEM’s deadlines, they have a right to move the mould base to another shop. However, this transactional relationship places all the risk on a start-up or an OEM looking to develop their next product. Mould crashes during manufacturing are more common than is usually thought. Typically, a custom moulder will charge the customer each time there is damage to the tool. Product line specific moulders Product line specific moulders can best be defined as a vendor. Moulding companies that fall into this category are already successful with their own product lines and are viewed as the experts in their component/product field. Typically, they are asked to either modify one of their existing moulds or build a new mould to meet a customerspecific demand. They usually do this with good results. However, it is important to understand the following points: • Their machine time for their own product lines will always be prioritized; • Often, they have high cavitation moulds and will not entertain a new product if the annual quantities are not in the millions of pieces; • They will quote inserts and pins (the functional part of a mould base) or quote the entire mould base as well. This is referred to as a NonRecurring Engineering (NRE Fee). The NRE covers the tooling and their time. However, they will still retain ownership of the tool; • They will make profit on the tooling as well as on the part; • If they do not meet your deadlines, you cannot move the tool to another moulder; and • If the part is similar to something they currently run, the customer will be charged according to their existing price structure.

HYBRID MOULDERS As we know, not every new project immediately demands millions of parts, and a new project (or start-up company) cannot justify the high costs of building a mould base. Enter the hybrid model. Hybrid moulders are a combination of a custom moulder and product line specific moulder. Their focus is on developing relationships with customers by offering flexibility and transparency. Hybrid moulders can therefore be best defined as a partner. Like the custom and product specific moulder, the hybrid moulder will begin the quote process with the same questions, i.e. ‘What are the annual quantities?’, ‘What are the material requirements?’, and ‘What is the target price?’. The next step is where the hybrid moulder differentiates themselves from the other two. They will first see if the product fits in a current mould base. If it does: • Making profit on tooling is not the main goal of a hybrid moulder. They would much rather perform well and run the customer’s product for years. A common NRE covers the cost of the tool and the cost of managing the project (i.e. creating drawings, designing tooling elements and validation costs); • The hybrid moulder will ask the customer if they need exclusivity. If so, the NRE will result in the customer owning the tooling. If the hybrid moulder doesn’t perform, the customer is free to take their tooling elsewhere; and • If exclusivity is not needed, the hybrid moulder will determine whether or not they would like to add the part to their own product

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COMPONENTS AND ASSEMBLY

offering. If so, this opens up flexibility for the customer. The hybrid moulder may decide to cover the costs of the tooling in exchange for marketing it as their own product too. Since the hybrid moulder is paying for the cost of tooling, the tooling will remain in their ownership. If the product does not fit in a current mould base: • A new mould base will need to be built and the quote will follow more closely along the lines of a custom molder; and • The differentiating factor here is that if the mould base fits a future product line the hybrid moulder is planning on releasing, they may offer to assist in covering some of the tooling costs. PREPARING FOR DISCUSSIONS WITH MOULDERS Additional items to consider when evaluating a moulder are whether a controlled clean room is required, their reputation, the moulder’s validation processes, their lead time and any regulatory requirements such as ISO 13485:2016. When contacting a moulder, it is best to have answers to as many of the following questions readily available. Quotes can be provided with minimal information. However, to avoid miscommunication and potential surprises, answers to the following points are highly recommended.

• Does the customer have a 2D drawing or 3D model readily available? If not, is a sample available? If drawings or samples are not available, a moulder’s design team can assist. • What is the estimated annual quantity? • What is the target price expectation? (moulders ask about quantities and target piece prices to determine the cavitation of the tool. A cavity makes one part. The higher the cavitation, the lower the piece price. However, the mould base will be more expensive as it is larger) • What are the material material requirements? Does the customer know the type and grade of the material? Are any regulatory items required; such as RoHS, Reach, DEHP free, TSE/BSE free, biocompatibility information, will the material be acceptable with the upcoming EU MDR criteria? If the material is not known, the moulder can still make a material recommendation upon learning more about the end use application and sterilization requirements. • What is the customer’s expected timeframe? • Will the part be used in a new or existing product line? • Are there any patent considerations or potential patent issues? • Are there any specific packaging requirements? Injectech, LLC has been using the hybrid moulding model since the company was formed in 1998. Our team has multiple years of experience with all three moulding models mentioned above. Our difference can be found in flexibility, utilising internal capacities to lower costs, and a focus on the customer’s needs. Injectech is confident in the hybrid moulding model and firmly believes it is a customer’s right to take their tooling to another shop if needed. Injectech also believes it is their responsibility to ‘make it easy’ for their customers to buy a product.

COMPONENTS AND ASSEMBLY

Demanding standards BARRY RATTENBURY, BUSINESS DEVELOPMENT MANAGER AT ELESA (UK) LTD, ON MEETING THE DEMAND FOR MEDICAL-STANDARD COMPONENTS IN THE AGE OF COVID.

he industrial marketplace has seen many shortages in meeting the needs for important equipment, especially at a time when demand for medical-related standard components has seen marked increases. This has been challenging to manufacturers of specialist equipment and their components. Fortunately, Elesa has been able to step up with the instigation of a ‘Smart Working’ programme, which has provided high volumes of indexing plungers, ball spring plungers and fluted grip knobs – all vital for hospital beds and ventilators. Additional quantities of moulded plastic and stainless-steel components have been essential, especially within precision instrumentation, disability aids, and machinery in environments that require corrosionresistant materials. Elesa’s Smart Working programme has drawn on a great depth of capability as a component manufacturer, as well as on a long-running investment programme that has ensured the availability of the latest in high-speed, automated injection moulding equipment. This combination of technologies and protocols has enabled Elesa to focus on ‘selfSANitising’ products for use where anti-microbial and clean capabilities are crucial. The programme has brought together threads of a longstanding technological background in the production of plastics-based components coupled with experience in working alongside international raw materials producers. These factors enabled Elesa’s engineers to augment production of advanced multi-layer components and the highly finished surfaces required for medical applications. By building on this foundation, Elesa has been able to draw on a production capability of over 45,000 product codes, with annual outputs of tens of millions of pieces derived from more than 200 worldwide patents and 43 international awards. Experience in ISO 9001, ISO 14001, BS OHSAS 18001 and AEOF certifications meant that much of the difficult and time-consuming testing had been done in advance. The basis of corporate capability already included many standard components in plastic, with stainless steel inserts or entirely made in AISI stainless steel. All of which are ideal for hygiene and medical applications. Material selection is key, and in the most demanding situations, constant prevention and self-sanitisation is achieved with components in a special engineering technopolymer containing silver ion additives in an inorganic base. Such materials utilise a silver biocide particulate inclusion which has no active pharmaceutical ingredients, antibiotics or pesticides. However, proven to prevent the proliferation of microorganisms by penetrating the surface of the cells and attacking their DNA – although sadly not effective on the Coronavirus itself – the controlled release mechanism of silver ions ensures that this material maintains the performance of SAN-Antimicrobial standard components. SAN-Antimicrobial components are destined for medical and hospital equipment, amongst other applications. This is a range which has recently been enlarged to address the worldwide problem of antibiotic resistance.

Laboratory tests show that 98.9% of bacteria are eliminated over the course of 24 hours (ISO 22196: 2011) – the test does not relate to viruses. All components of the SAN-Antimicrobial line are provided with the Statement of Compliance ‘Antimicrobial Properties of Materials’. Tests were carried out by CSI SpA, a laboratory accredited and recognised by Accredia (n.0006), the Italian National Accreditation Body. The laboratory complies with the requirements of UNI CEI EN ISO / EC 17025. Certificate identification: C0144 \ FPM \ FOOD \ 19_1_2. A recent introduction has been the new white CLEAN line components in RAL 9002, which were introduced as they are particularly suitable to medical environments. SAN and CLEAN components are complimented by an INOX line of plastic products with stainless steel inserts. Whether in the hospital or the community, Soft-Touch technology meets a wider need for high-quality, user-friendly components. This multielement production approach uses an FDA-certified TPE coating that provides a secure, comfortable grip. Comfort in the hand is paramount in this range, which is suited to disability equipment and frequent operation. The addition of colour in the moulding material, or caps and covers, offers a wide palette to match customer-specific applications. Throughout the pandemic, ELESA has provided an extensive range of products in engineering plastics and metal, designed for medical equipment, precision instruments, rehab and disability aids – even for applications requiring the use of corrosion resistant materials. With 12 global branches, and in close collaboration with the most prestigious distributors worldwide, ELESA has also been able to ensure efficient and timely service.

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COMPONENTS AND ASSEMBLY

Automation coll TAD ORSTAD, DIRECTOR OF OPERATIONS, ACTION PLASTICS INC. (API), AND ZAC BOGART, PRESIDENT, PRODUCTIVE ROBOTICS, ANSWER QUESTIONS ON API’S RECENT ACQUISITION OF THE OB7 COBOT.

ow has introducing the OB7 to your manufacturing space helped improve efficiency and productivity? Tad Orstad: For off-the-press material handling, Productive Robotics’ OB7 cobot has eliminated some of the mundane and/or noisy environment tasks. Moulded parts material handling is one example. This allows operations team members to work in other areas of the operation that are more skilled/ developed operator dependent.

we became more familiar, we then integrated outside sensors and controls for conveyors, imaging and finished goods movement. What are the standout characteristics of the robot? TO: What stands out most to us is the ease of the ‘no programming’ approach, the flexibility introduced by the seventh joint that many others do not have, and the speed when operated within a safety zone free of operations team members. Zac Bogart: OB7 cobots were designed to make it simple for manufacturers to implement cobots into their production without complexity or high costs involved with hiring outside integration support. There are several characteristics of OB7 cobots that make them simple, flexible, and smart, but a few that stand out most to our customers, including zero programming, seven-axis flexibility, seamless integration, and affordability, as well as fast RoI.

In our work for medical applications, we have integrated a vision inspection station with OB7 for inspection of a medical filter housing to look for bubbles and impurities on a finished goods housing. OB7 pulls a part from the infeed conveyor tied to the moulding press, then places the part onto a turntable, allowing for a rapid inspection in six different orientations. Finally, OB7 places the inspected part into either the approved finished goods packaging or into a nonconforming bin. Before we automated this process, there were inherently inconsistencies between the different operators and shifts. In other applications, we have used OB7 to automate adhesive dispensing and final assembly processes. Its consistent repeatable positioning and precision resolved quality issues cut job time, and allow for a more competitive finished goods price.

Our cobots require zero traditional programming or coding to use. Operators simply ‘show’ OB7 a task by guiding its arm, and it automatically learns and remembers the task for next time. While simple, OB7 is not limited in capability and can handle basic pick and place tasks to more complex jobs like CNC machine tending. All models of OB7 have seven moveable joints (or axes), like a human arm. The 7th axis flexibility makes them more manoeuvrable, adapt better to installations that were previously manned by a human operator, and reach around obstacles, which other cobots cannot. OB7 can seamlessly integrate into existing production lines and start working quickly. This eliminates downtime waiting to re-engineer production lines and waiting for software programming. Its rolling stand also provides portability and a small footprint that enable staff to roll in and out of different jobs with ease. Designed and manufactured in Santa Barbara, California, Productive Robotics’ OB7 cobots are built with the latest technology that didn’t exist 10 years ago. This drives the price down and improves the high reliability of the cobots. Its simplicity, flexibility, and cost drive fast RoI, sometimes in as little as a week.

Where did Action Plastics first hear about OB7, and how easy a decision was it to integrate the technology into your production site? TO: I was at Automate 2019 in Chicago to look specifically for a cobot. It was a great opportunity to see several in action and meet with the various teams representing the companies. It was at the show that I first became aware and acquainted with the OB7. Integration to our production site was smooth, as teaching the moves and actions was easy to pick up. As 36

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laboration What was the reaction of your employees when the robot was introduced? TO: Initially, many of the operations team members were concerned about replacement or redundancy, but we assembled the OB7 and support structures out in the open on the production floor, for all to see. When we started to learn how to teach the cobot, we did this on the production floor as well. It was a methodology to allow team members to see and observe as we on the engineering team were learning as well. This helped reduce safety and interaction concerns, as well as allow people to ask questions or offer suggestions. What would you say to manufacturers who remain skeptical about robotics and automation in their production processes? TO: Perform your research and identify areas of operations where you may have inconsistencies based upon shift or operator variability. Routine manual operations are prime candidates for robotics. The ease of integration to existing processes can be realised with a little up-front planning and design. Keep the robot as a flexible asset, it does not have to be fixed to a single location or process. ZB: There are a number of reasons why manufacturers may be skeptical of collaborative robotics and automation – they may be too costly or complicated, or they’re worried about taking jobs away from people, just to name a few. Our customers have found the opposite to be true. By eliminating the barrier of programming, OB7 makes it easy for manufacturers to implement into their production. Rather than take away jobs, our customers notice an increase in their productivity and in their employees’ productivity with OB7. It frees staff from repetitive, mind-numbing tasks, and allows them to focus on more complicated work. Businesses that use cobots are becoming more efficient, more flexible, and more competitive in their production. We invite anyone to get in touch with us or participate in one of our demos to see how cobots can fit into their manufacturing. We are happy to talk through any questions or discuss potential cobot automation projects. How has demand for plastic components in the medical sector been affected by the events of the past year? TO: We at Action Plastics have had an overall increase in demand, especially in filtration applications. There are a couple of sub-sectors of our medical manufacturing that have had decline in the early weeks of COVID, but these

have rebounded to near pre-COVID run rates or to customer forecasts for 2020. How has OB7 contributed to waste reduction, energy efficiency, and other environmental considerations? For the application where we are now performing post moulding inspections, we have documented a drop in scrap from approximately 15 per cent to four per cent. This has been attributed to consistency in inspection processes and reduction of operator variability. This particular product is a virgin material only specification, so the resulting material loss being sent to landfill or recycling has dropped significantly. In energy efficiency, we’re now able to run the press faster due to the OB7 being able to inspect and material handle faster than we had planned with an operator. This has resulted in a total electricity consumption reduction for these moulding jobs.

The ease of integration to existing processes can be realised with a little up-front planning and design WWW.MEDICALPLASTICSNEWS.COM

INJECTION MOULDING

ANATOL SATTEL, DIRECTOR BUSINESS DEVELOPMENT MEDICAL AT SUMITOMO (SHI) DEMAG, DISCUSSES HIS APPOINTMENT AND THE FUNCTION OF MEDICAL-BASED INJECTION MOULDING MACHINERY.

Injection for protection

ou were recently named Director Business Development Manager - Medical at Sumitomo (SHI) Demag. What does it mean to you to know the company has placed such responsibility on your shoulders? I feel honoured by this decision. However, there is a great team supporting me and I feel quite comfortable with the responsibility based on my past industry experience. Furthermore, the new structure we have created in the entire Sumitomo Plastics Machinery Division provides a robust platform where experts, like myself, are able to contribute strategic ideas directly to ensure medical customers continue to receive the very best technology, automation concepts and service support. Which other stakeholders’ inputs do you find most valuable in helping you with these responsibilities? There is great support from the industry partners, many of whom I have worked and collaborated with for a long time. It’s a great privilege to call these partners friends who are always proactive in sharing their expertise and application advice. Additionally, I maintain close personal contact with the company’s General Manager in China, Pietro Scattarreggia, who was previously in charge of business development in medical and electronics here at Sumitomo (SHI) Demag and continues to have a strong focus supporting manufacturers that are driving developments in high-end medical segments in Asia. It’s always very useful to share how different markets and applications are evolving, especially in the medical field.

precision, the new 180 tonne all-electric machine is also proven to deliver the highest repeatability and cleanliness. Specifically, the latest generation of the IntElect S series has been designed to handle extremely narrow tolerance medical applications produced in high volumes, and is cleaner, cooler, faster and quieter. With the large tie bar distance and the possibility to significantly extend the mould height, Sumitomo (SHI) Demag has engineered a system that can accommodate large moulds combined with very small injection units. Additionally, the Japanese-developed highly dynamic drive technology improves the dosing and injection performance, which is so critical when moulding micro components like pipette tips. This precision results in a higher quality medical component. However, one of the biggest point of differences is how the people selling our medical IntElect systems truly understand the machinery, how the features add value, the GMP standards and other regulatory developments, as well as each customers’ unique medical applications. Which Sumitomo (SHI) Demag medical-based products/components are in high demand currently? Currently the market for IVD is booming, especially to support the devices which perform COVID-19 tests. The main products are pipette tips and PCR-plates. Drug delivery devices still remain a stable pillar in the current economic situation. How do you hope to get Sumitomo (SHI) Demag’s message across to the medical plastics industry with the cancellation of so many trade fairs? This has been an unprecedented year, especially with the cancellation of Chinaplas and Fakuma. However, Sumitomo (SHI) Demag has responded in several ways. Our industry-focused new sales structure was already in the pipeline and enables us to use the existing industry competence and expertise in a much more targeted and efficient manner for the benefit of our customers. Additionally, we established a special programme in collaboration with our major industry partners, delivering machines and supporting key market research and development initiatives. By supplying these resources that we would have showcased at events, we continue to support transformative projects, maintain Sumitomo (SHI) Demag’s preferred partner position, and convey our longstanding message that we are the ‘easiest to work with’.

Which machines in the Sumitomo (SHI) Demag range are best suited to manufacturing in the medical industry and why? The precision IntElect series was specifically designed for the medical sector. Last year we launched at K 2019 the precision IntElect S medical package. Built for high-speed and

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INNOVATION

KEN BLOCK, PRESIDENT, KEN BLOCK CONSULTING LLC, SHARES HIS EXPERTISE IN HELPING MEDICAL DEVICE MANUFACTURERS GAIN FDA BREAKTHROUGH DEVICE STATUS.

edtech companies around the world are taking advantage of the many ‘fast-track’ benefits of the FDA Breakthrough Devices Program, including those in the UK. Any organisation with novel and important new medical device technology intended for the US market can voluntarily apply for and gain the formal Breakthrough Device designation using the FDA’s Q-Submission system, as long as certain criteria are met. These innovative and impactful devices must still be under development (not quite ‘market ready’). However, the technology must also have achieved enough development progress to convince the FDA reviewers that the devices have reasonable probability of technical and clinical success.

Request for Breakthrough Device Q-Submission’ must closely follow the principles outlined in the two applicable FDA guidance documents shown below: • Breakthrough Devices Program (published December 18, 2018); and • Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program (published May 7, 2019).

As stated by FDA: “The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency’s mission to protect and promote public health.”

Examining our client successes with this special FDA program can provide some insight to the devices of interest to FDA:

Gaining Breakthrough Device status wins close collaboration with internal FDA experts in the development of the subject technology, as the device approaches market readiness. This collaboration includes frequent meetings with FDA staff to discuss critical issues, mutual agreement on the data needed to pass FDA scrutiny, senior FDA management involvement in the Breakthrough Device process, and priority review of the eventual FDA marketing authorization submission, such as 510(k), De Novo, or PMA. In our experience gaining Breakthrough Device designation for one UK client and one US client with completely different technologies, the key to success is creation of the appropriately strong and convincing Q-Submission. This formally submitted ‘Designation

Following these documents, each application must first convince the FDA review team that the subject device provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or condition. In addition, the application must also convincingly argue that at least one of the following applies: • the device represents breakthrough technologies; • no approved or cleared alternatives exist; • significant advantages over existing approved or cleared alternatives exist, including the potential (compared to existing approved alternatives) to reduce or eliminate the need for hospitalization, improve patient quality of life, facilitate patients’ ability to manage their own care, or establish long-term clinical efficiencies; and • availability of the device is in the best interest of patients.

UK CLIENT Leveraging research spun out of Oxford University, the novel Cortical Disarray Measurement (CDM) Software Device under development by Oxford Brain Diagnostics Ltd. uses MRI brain scan data to predict conversion to Alzheimer’s disease for those patients who have already been diagnosed with Mild Cognitive Impairment (MCI). Having such technology available would greatly benefit both practitioners and patients. US CLIENT The laser-based FLOXsp device under development by Neural Fiber Optic Systems, Inc. (NFOSYS) is intended for accurate and realtime monitoring of spinal cord fluid. This impactful technology has the promise to help reduce the occurrence of spinal cord ischemia (SCI) complications of patients undergoing a variety of surgical procedures, which in turn could help avoid patient paralysis. Both of these devices promise to greatly increase the Standard of Care (SOC) for important medical practice areas. If your organisation is developing similarly impactful technology, the FDA Breakthrough Devices Program could accelerate your device’s US market entry.

WOMEN’S HEALTH

WHAT TO EXPECT IF YOU’RE EXPECTING DURING COVID-19 DR LUCY MACKILLOP, CHIEF MEDICAL OFFICER AT SENSYNE HEALTH, HIGHLIGHTS THE INCREASINGLY IMPORTANT ROLE OF REMOTE PATIENT MONITORING (RPM).

regnancy and becoming a new parent can be a daunting prospect for many, and the pandemic has increased the risk of anxiety and depression in this vulnerable group. With the UK government’s call for pregnant women to practise stringent social distancing and limit face-to-face contact during the Covid-19 outbreak, there has been a concern that women are avoiding clinics and not seeking the in-person health check-ups they need during pregnancy. This can be of particular concern in women with pre-existing health conditions such as diabetes or hypertension, as well as in those with other pregnancy related health conditions. This has the potential to impact thousands of women in the UK. In fact, last year it was estimated that 20% of pregnant women in the UK were affected by gestational diabetes, while up to 15% of pregnancies are affected by hypertension. Gestational diabetes can cause problems for the mother and baby both during pregnancy and after birth. But the risks can be reduced if the condition is detected early and is well managed. Left undetected or untreated, it can cause problems including larger babies, difficulties during birth, neonatal complications such as jaundice, and even stillbirth. Medical problems in pregnancy such as the examples above are increasing in prevalence world-wide, largely driven by demographic and lifestyle changes. It is, therefore, even more important that we learn from the rapid uptake of technology for remote monitoring during the Covid-19 pandemic to ensure treatment is provided to those who need it the most, wherever they may be. So that we can best use it to support women and healthcare professionals now and in the future. SENSE OF SECURITY WITH RPM As a precaution, pregnant women have had to reduce their hospital visits where possible during the pandemic. A concern has been the risk that less face-to-face appointments may drive increased anxiety amongst this vulnerable group, with less contact and direct support from their clinicians. Coupled with recent research which suggests that pregnant women have an increased risk of severe Covid-19 infections, this presents a significant opportunity for RPM to not only shield women from pandemics, whether now or in the future, but also ensure they are able to receive the best care by keeping in regular contact with midwives and doctors, from the comfort of their own homes. This form of remote monitoring can have significant impacts on a woman’s sense of security and wellbeing during pregnancy - particularly in a time of great uncertainty.

help manage blood glucose levels. By mitigating the impact on our health services by using data effectively, healthcare resources can be focused on where they are needed most. EMBRACING RPM BEYOND LOCKDOWN We may be beginning to ease lockdown and trying to resume life as close to normal as possible but staying safe and taking control of our health will continue to be a priority - especially for vulnerable groups such as pregnant women. The pandemic has tested the flexibility of our healthcare systems and underscored the value of RPM, which is taking huge strides to help the National Health Service manage large numbers of patients, at the same time empowering us to proactively manage our health, and is instrumental to managing demand on our overstretched healthcare systems. RPM will become more commonplace as we see more digital technologies embedded into routine clinical care, helping ease us into the changed world we find ourselves in.

Remote monitoring via smartphone apps is becoming the new norm and has huge potential to help women access antenatal and postnatal care during challenging times. GDm-Health and BPm-Health are examples of prescribed digital therapeutics for the remote monitoring of diabetes and self- monitoring of blood pressure respectively, helping clinicians to monitor women’s health remotely in near real-time. This could include checking women’s glycaemic control with blood glucose readings, and prioritising care to women most in need whilst maintaining at a glance, oversight of all patient cohorts. Understanding patient conditions better with the rich source of data from RPM applications, may help clinicians make earlier diagnostic or treatment decisions whether that’s advising dietary changes or recommending exercise for pregnant women to

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DESMA Xpert Forum concludes successfully 1

25 days, 45 countries, more than 1,300 registered persons, and more than 16,000 page views.

Participants confirmed that DESMA is well on the way to success with consistent digital reorientation.

The digital trade fair concept was rated four out of five stars by visitors in a survey.

DESMA would like to thank the numerous visitors who have taken another step into the future.

11:2020 Medical industry adopts Stratasys’ J750 digital anatomy 3D printer

year after the launch of its J750 Digital Anatomy 3D printer, Stratasys has successfully sold and installed the system at healthcare institutions and medical service providers in major markets across the globe. In Spain, two technology institutions have invested in the Digital Anatomy 3D printer to pioneer their medical service offering. Both cite the unrivalled

ultra-realism and tactile nature of the models as a significant competitive advantage. The J750 Digital Anatomy 3D printer produces anatomical models that mimic the feel, responsiveness, and biomechanics of human anatomy. Models can be punctured, sutured, cut, and physically manipulated like actual human tissue.

MEDTECH EUROPE LAUNCHES AI REPORT

edTech Europe has published a report outlining the socio-economic impact of AI in healthcare and the barriers to its adoption for new healthcare technologies in Europe. The study covers eight AI applications categories – wearables, imaging, laboratory applications, physiological monitoring, real-world data, virtual health assistance, personalised apps

and robotics – that can be used across the entire patient journey. Serge Bernasconi, CEO at MedTech Europe, said: “Artificial Intelligence can address many healthcare challenges and the EU has the potential to lead this area by building an advanced regulatory environment, enabling trustworthy AI and ensuring greater patient trust.”

WIDEBLUE SCALES UP PERSONAL CAPNOMETER IN FIGHT AGAINST COVID-19

cotland-based design and development company Wideblue is accelerating production of a groundbreaking new medical device which could help the UK NHS quickly discover which COVID19 patients are deteriorating and need a ventilator.

Wideblue MD Russell Overend said: “Wideblue has made 200 devices already and has a purchase order for another 1,000 units which will be manufactured over the next few weeks. These devices were destined for clinical trials with COPD and Asthma patients, but

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these devices are now being reconfigured and reallocated to COVID-19 patients. We are very hopeful these N-Tidal devices can be deployed in hospitals within the next couple of weeks”.

MedTech Group