MPN EU Issue 65

EUROPEAN EDITION

Medical Plastics N E W S

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I N T E R N A T I O N A L

The Journey Towards Intelligent Catheters The technology behind the breakthrough in medical device cables

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PACKING UP THE PANDEMIC IT’S NOT SO EASY BEING GREEN A DIGITAL TOOLBOX FULL OF POSSIBILITIES

ISSUE 65

Apr/May/Jun 2022

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CONTENTS MPN Europe | Issue 65 | Apr/May/Jun 2022

Regulars

Features

5 Comment Olivia Friett comments on the new role as editor of Medical Plastics News

9 Components and assembly Trelleborg share their goals for the future to keep the carbon footprint at an all-time low

6 Digital Spy Sharing some of the latest news in the healthcare market

20 Micromoulding Accumold explain how to choose the right micromoulder in the medical market

14 Cover story Junkosha highlight the importance of intelligent catheters 34 Q&A 4D Bioprints’ advisor explains how their dissolvable implanting device is different to the rest on the market

22 Industry 4.0 EU Automation outline the potential disruptions in supply chains and how to overcome them 28 Testing and inspection Sempre Group explain how metrology can bring design and manufacturing processes together

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CYROLITE® has been working in hospitals and

Lipid-resistant, BPA-free, and highly transparent: CYROLITE® acrylics are the reliable invisible helpers in hospitals and labs.

labs for more than 40 years. Thanks to their excellent properties, our high-performance acrylics are perfect for use in a wide range of medical devices. CYROLITE® is highly transparent and easily processed into intricate parts. It can be reliably sterilized using most common methods and is BPA- and DEHP-free.

This has impressed both patients and healthcare professionals alike: CYROLITE® meets the requirements of USP Class VI, ISO 10993-1, and REACH. You can find more details at www.cyrolite.com.

editor | olivia friett olivia.friett@rapidnews.com advertising | caroline jackson caroline.jackson@rapidnews.com advertising | christine joinson christine.joinson@rapidnews.com

Editor’s Comment

advertising | victoria dunsmore victoria.dunsmore@rapidnews.com

OLIVIA FRIETT

vp, sales & sales talent | julie balmforth julie.balmforth@rapidnews.com

START OF SOMETHING NEW

head of studio & production | sam hamlyn graphic design | matt clarke publisher | duncan wood Medical Plastics News NA Print subscription - qualifying criteria US/Canada – Free UK & Europe – £249 ROW – £249 Medical Plastics News Europe Print subscription - qualifying criteria UK & Europe – Free US/Canada – £249 ROW – £249 FREE on iOS and Android devices Subscription enquiries to subscriptions@rapidnews.com Medical Plastics News is published by: Rapid Life Sciences Ltd, Carlton House, Sandpiper Way, Chester Business Park, Chester, CH4 9QE T: +44(0)1244 680222 F: +44(0)1244 671074 © 2022 Rapid Life Sciences Ltd While every attempt has been made to ensure that the information contained within this publication is accurate the publisher accepts no liability for information published in error, or for views expressed. All rights for Medical Plastics News are reserved.

Reproduction in whole or in part without prior written permission from the publisher is strictly prohibited.

BPA Worldwide Membership ISSN No:

2047 - 4741 (Print) 2047 - 475X (Digital)

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ello and welcome to the Q2 issue of Medical Plastics News. My name is Olivia, and I am the new editor. I knew I wanted to be an editor since I was a teenager so writing this feels very surreal. It’s been a lot harder than I imagined but also so much more exciting than I envisioned. I think I started at the perfect time too; I get to have the luxury of a hybrid working arrangement. All of this while getting to learn the life sciences industry, especially my domain in medical plastics.

I have had the opportunity to travel already; I got to go to California in April for MD&M West.

Even though it was smaller than expected, I didn’t quite make it around all 1,400 exhibitors.

There was no better destination for me to experience the returning buzz of trade shows than in the Golden State of California. More than anything, it felt incredible flying globally again, being around so many people and finally getting a sense of normalisation for the first time in over two years.

There is so much more to look forward to just this year alone, including our own Med-Tech Innovation Expo in Birmingham, UK. I have heard so many great stories about it from my team and it looks like a great event! This expo is going to be very insightful, as I am starting to learn that with this job, you can never know everything – every time I speak to someone or see a different device, I’m learning something new, and I can’t wait to learn more.

Covid-19 is still around and isn’t going away anytime soon.

One interview in this issue is from a food packaging company who then created a whole new system using their expertise in the food sector to make Personal Protective Equipment during the pandemic and then went on to win awards. Another company featured in the issue was working 24-hours a day to try and keep up with the demand during the Coronavirus peak. So, for keeping us safe, and of course being a part of my first magazine, I would like to thank all the companies featured in here. Even through these novice’s eyes I recognise the change that this sector has experienced.

I have loved every moment of making this magazine, speaking to new people and learning new things. I’m very excited for this new chapter as editor and to see what happens. I hope you enjoy reading my first issue as much as I enjoyed writing it and please let me know what you think. I’m looking forward to working with you all in the future.

In this issue, I’m sure you will learn something new too. A common theme throughout, is the notorious Coronavirus. Global travel is back at its norm, hospitals are no longer feeling overwhelmed, and coverage of the pandemic is no longer considered ‘breaking news’, but

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DIGITAL

spy

www.guill.com

DRUG DELIVERY UPDATE

Guill introduces the latest generation of its Series 800

www.covestro.com Covestro and PharmaJet take the sting out of vaccinations

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ovestro is collaborating with PharmaJet over needlefree injection technology.

The PharmaJet systems require a polycarbonate material to meet the specifications of the syringe and vial adapter while standing up to gamma radiation and ethylene oxide sterilisation, with Covestro supporting PharmaJet’s material needs.

EXTRUSION UPDATE

“We needed a polycarbonate resin that was suitable for our biotech applications and came from a vendor we could rely on,” said Chris Cappello, president and CEO, at PharmaJet. “Covestro has provided great support to PharmaJet in the fight against COVID-19, allowing the collaboration to achieve better immunological results than needle and syringe delivery.”

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uill Tool, a global manufacturer of extrusion tooling, has shared the latest generation of Series 800. The 2-to-6 layer extrusion tooling is designed to produce the highest quality, highest material-efficient 1/8” to 6” OD tubing for automotive, medical, appliance and industrial applications.

The redesigned Series 800 produces extrusion and layer definition of Fluropolymer and other materials for all multi-layer, multi-lumen medical tubing, as well as fuel line constructions, multilayer PEX pipe and drip irrigation applications, among others. The Guill design further allows thin layer combinations of polymers and adhesives to .02mm or less.

Guill offers its line of crossheads and inline

tubing dies in fixed and adjustable centre, for single or co-extrusion applications. The tooling is designed to process all compounds and features the company’s patented, precision Feather Touch Concentricity adjustment, the Seal Right System, which combines with the Feather Touch system to eliminate polymer leaking.

INJECTION MOULDING UPDATE

www.ana-u.com

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ANA-U relies on injection moulding technology from the Wittman Group

or just under three years, ANA-U has been producing moulded parts from natural substances under the “Green Quality” brand. These consist of 100% plant-based renewable materials and are compostable just like wood.

The Green Quality moulded parts are manufactured on an all-electric from Wittman Battenfeld. The EcoPower 160/750 is equipped with a

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fully integrated Wittman W918 robot, which removes the parts and deposits them on a conveyor belt. A Wittman Tempro basic C90 temperature controller and a Gravimax 14 gravimetric blender are also integrated in the machine’s UNILOG B8 control system.

Ulrich comments: “Moulded parts made of renewable raw materials require production machinery with high precision and extended options for parameter setting.

This is provided in every respect by the EcoPower

Ewald Ulrich, founder and CEO of ANA-U, is very satisfied with the equipment from Wittman Battenfeld. Ewald

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160 from Wittman Battenfeld.

In addition to the high quality of the machine, the perfect training programmes and excellent customer support were decisive factors in reaching all our ambitious project goals.”

DIGITAL SPY

TREATMENT UPDATE

www.parxmaterials.com

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LABELLING UPDATE

CLINICAL STUDY SHOWS EFFECTIVE HPV TREATMENT

ervical cancer is the fourth most common cancer among women worldwide. More than 95% of cervical cancer is due to the human papillomavirus (HPV), and HPV types 16 and 18 are known to cause at least 70% of cervical cancers.

A current strategy to prevent

cervical cancer is by administering a vaccine that works best when administered prior to exposure to HPV, recommended for girls in the age of 9 to 14 years. But a treatment for patients infected with HPV is not available today.

Parx Materials, together with a number of partners in China, has developed a foam and a gel product to treat vaginal HPV-infections. These are easy to administer products that can treat HPV infections in a user friendly and cost-effective manner. The gel or the foam product is administered by the patient themselves and does not require a physician. The products are currently in the process for medical class 2 certification in China, which is expected to be completed in June 2022.

COLLABORATION UPDATE

www.owenmumford.com/en

https://p-r-i.org/medaccred/

Launch of new MedAccred programme labelling, printing and UDI focus area

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Owen Mumford and Stevanato Group strike Aidaptus auto-injector deal

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wen Mumford has signed an exclusive agreement with Stevanato Group for the Aidaptus auto-injector.

Stevanato Group will mould the components for Aidaptus and provide final and sub-assembly equipment, while also offering market-leading pre-filled syringes to enable pharmaceutical customers to create the final product for patient use.

Assembly of the components will be undertaken by both Stevanato Group at its global manufacturing sites and

by Owen Mumford at its automated assembly centre in the UK.

a self-adjusting plunger rod that automatically adapts to the individual plunger positions and different fill volumes in each syringe, with no change parts required.

edical device OEMs have launched a new MedAccred critical process focus area for Labelling, Printing, and Unique Device Identifier (UDI).

This will ensure that medical device information provided to medical staff and patients is reliable, accurate, complies with regulatory requirements and, most importantly, improves patient safety. The new assessment will help the medical device industry avoid costly warning letters and recalls by driving the adoption of stringent manufacturing process controls. It comes in response to changing and increasingly complex global requirements which place extra burdens on content management, product labelling, promotional material and UDI. Paweena Limjaroen, PhD, senior director of global labelling and packaging at Edwards Lifesciences, is chairing the new MedAccred Labelling, Printing and UDI Task Group to develop the industry MedAccred audit criteria, select subject matter expert auditors, and determine which companies meet the rigorous industry requirements to provide oversight for this critical process area. Limjaroen commented:

Aidaptus is a 2-step, single use autoinjector with a versatile design that accommodates both 1mL and 2.25 mL prefilled glass syringes in the same base device. It also features plunger sensing technology with

“In today’s ever-changing medical device-labelling landscape, it is more important now than ever to ensure labelling documentation is regulatory compliant. The MedAccred Labelling, Printing and UDI Task Group’s role is to provide medical device companies with structure and requirements to assist.”

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Medtech | Digital HealthTech | Medical Plastics | Manufacturing | Software | Inspection and Metrology Regulation | Design | Early-Stage | Innovation | Pharmaceutical | Manufacturing

MED-TECH INNOVATION

7-8 JUNE 2023

NEC | BIRMINGHAM | UK

Exhibit with us in 2023

Medical Device Supply Chain Intelligence

COMPONENTS AND ASSEMBLY

MEDICAL PLASTICS NEWS CAUGHT UP WITH TRELLEBORG AT MD&M WEST TO DISCUSS THE ONGOING DEMAND WITH PRODUCTS DURING THE PANDEMIC AND HOW THEY CAN MAINTAIN THEIR SUSTAINABILITY.

IT’S NOT SO EASY BEING GREEN

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relleborg, a specialist in engineered polymer solutions, aims to offer safe care for patients and a safe workplace for medical staff. The ongoing pressure of keeping people safe from the pandemic, does not take away from the rising demand on new and improved devices.

Kevin Ehlert, mergers and acquisitions director at Trelleborg said: “Our customers are constantly challenging us to get smaller, thinner walls. Our group is active in continuing to push the boundaries on their side, trying to develop capabilities because we know that as we go further on in the years, we’re just going to continually get challenged. So, we’re doing our own internal push to continue to own our skillset, to make sure that we can serve the market.

“It’s less of an impact on the patients. Basically, they don’t want it. They don’t want to know it’s there, or they want to walk around and feel normal. As instead of doing say open-heart surgery, going in through a catheter, through an artery is minimally invasive.”

Juggling demand and integrity is no easy feat; whilst working on new and improved devices, it’s important to remember how it’s going to affect the environment. Is this device single-use? Can it be disposed of in an ecofriendly way? Is there a way to make this more sustainable?

With over 21,000 employees in 48 countries, it’s important for Trelleborg to try and keep a lower carbon footprint. They have been developing a sustainability platform called ‘Protecting the Essential’. By the end of 2025, their goal is to reduce the company’s global CO2 emissions by 50% and judging by their 2020 emissions, they believe this is achievable. If that wasn’t enough, they are ambitious that they will have net zero emissions by the end of 2035.

“A big buzzword that we’ve had has been sustainability. There are lots of definitions of ‘sustainability’.” Ehlert commented. “You have to dispose of something if it’s single use. You are producing a lot of things that are disposed of. There’s a footprint from the single use systems. We and our customers are looking at what the future of that looks like. Part of it means reduction in materials.”

Does sustainability just mean something must be used multiple times? There are so many examples where single use items are not sustainable. Recently, there has been

A big buzzword that we’ve had has been sustainability concern about the amount of waste caused by single use face masks and other PPE. But what about the behind the scenes of running multiple use devices? Fletcher said: “You have a large stainless steel, more permanent infrastructure, which takes a lot of harsh chemicals to clean. The standard to sterilise and get that ready for the next batch. So, it’s not that the other methods have no impact.” It really is all about trying to find that balance.

Asking a few people was not enough for Trelleborg - by giving surveys to customers, employees, and shareholders, they have been able to identify the aspects of concern. The results highlighted issues such as energy consumption, emissions to air and water, the use of hazardous chemicals and, of course, the importance of a safe workplace.

Credit: Trelleborg

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COMPONENTS AND ASSEMBLY

CHRIS PHILPOTT, BUSINESS DEVELOPMENT MANAGER AT BODDINGTONS OUTLINES THE FACTORS INVOLVED IN COMPONENTS AND ASSEMBLY.

PUTTING IT ALL TOGETHER

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at Boddingtons

lthough the Covid 19 situation may seemingly be calming down, the early stages of the pandemic revealed much about the world’s medical supply chains, the awareness of the design and manufacturing process and the state of healthcare supply generally.

Chris Philpott says that “Covid was not so much a wake up for medical devices but more like a spotlight on practices in the sector – some good, some bad.”

Marden-based Boddingtons was involved in several Covid device projects from the outset, including the company’s role in contributing to the UK’s ventilator manufacturing effort: At its peak, Boddingtons was manufacturing seamlessly for 24 hours a day for this project to satisfy demand.

The emergency project came about due to the high volumes required but with exceptional turnaround via a tool transfer request from the OEM responsible and teamed Boddingtons with other OEM participants.

At the end of this road, the outcome for Boddingtons clients is that the

company moulds, assembles, tests, packages and sterilises all medical components and devices that leave the factory gate.

“All components are manufactured under our Quality Management System (QMS) certified to ISO 13485:2016 MDSAP,” says Philpott “and we thereby provide full control and traceability for all raw materials, manufacturing and sterilisation processes.”

He adds that “as the manufacturer, it is also our legal responsibility to make sure that all product is packaged and protected before it leaves us for the customer. The comprehensive validation processes demand full testing of the chosen specification that will go into the marketplace. We must continually monitor the performance of medical device packaging – for example sealed pouches for actual seal strength to make sure they maintain integrity and meet the initial validation and product specification.”

The sterility of injection moulded products within devices and the protection of the sterile barrier is key. Philpott explains that “a whole host of pull tests, die penetration tests - including visual inspection - are performed throughout the process.”

This also requires components and assemblies to be clearly labelled and identified – and here lot traceability is key.

This ‘belt and braces’ approach to client management means that Boddingtons is often approached by OEMs when their management of suppliers has become too distant, or when quality issues have deteriorated to unacceptable levels.

“These component projects are not necessarily too complex,” Philpott explains, “but they often reflect a breakdown of priorities between moulder and customer.” Some may simply involve optimising the volume and quality for a single high-volume component. Some may also involve reshoring mouldings from the Far East simply to improve lead times, project management and product quality.

Such tooling and moulding transfers regularly involve a complete reexamination of what may have been considered best business and industrial practice some years prior. Since then, the tooling may have had many tens of thousands of hours in use and may need extensive repair, reconstruction, or replacement. Grades of polymer may have developed and improved since the original component design. Boddingtons will review and recommend upgrades and changes when recommissioning production of the new component.

Assembly cells at Boddingtons might include automation, welding, hand assembly, Hi-Resolution supported Camera QA inspections, packaging, and printing services before dispatch.

“At no stage”, says Philpott, “did we feel hampered in terms of production resource or production space. Several manufacturing aspects – sharps inclusion and handling; automated UV curing and others – were completely new to us.”

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MED-TECH INNOVATION EXPO

MED-TECH INNOVATION EXPO IS FINALLY HERE, AND OLIVIA FRIETT INFORMS READERS WHAT THEY CAN EXPECT TO LOOK FORWARD TO FOR ALL THINGS MEDICAL PLASTICS.

THIS IS THE GREATEST SHOW

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hings are finally getting back to normal and what better way to celebrate than by seeing the return of Med-Tech Innovation Expo in Birmingham, UK as part of Manufacturing Week.

There will be plenty on offer for those in the medical plastics industry.

Last but certainly not least, the Medilink UK Pavilion is due to return in 2022. Our partner, Medilink UK, is a national health technology business which, for nearly two decades, has supported manufacturers, service providers, OEMS, designers and suppliers of medical technology.

UP AND COMING INNOVATORS This expo truly has something for everyone! The Start-up Zone will be full of new technology from start-ups, research projects, non-profit organisations, spinouts and small businesses to bring their innovative minds and services to the market in the most money-friendly way.

If you don’t know where to start when you’re planning your visit, let’s break things down for you and pick out a couple of highlights.

​​ Those participating will be showcasing their innovations in our PITCH@ Med-Tech Innovation Expo competition on Day 2 on the Introducing HealthTech stage.

COME AND CONNECT Whether you’re meeting up with existing connections or setting meetings up with new contacts, the Connect Lounge is perfect for everyone. If you register in advance, you can receive recommendations too, to ensure you’re getting the most out of the event.

TAKE TO THE STAGE Med-Tech Innovation Expo has two stages for you to look forward to; attendees can expect not only the Med-Tech Innovation Conference but also the Introducing Health-Tech Conference too.

AN INTERNATIONAL EVENT There are three pavilions this year; the Mauritius Pavilion, Medilink UK Pavilion and new to 2022, there is the Italian Pavilion. The Italian Pavilion will be hosted by the Italian Trade Agency and will bring together 18 of the country’s top innovators in the medical manufacturing space.

The Mauritius Pavilion will be hosted by the Economic Development Board, which is the national investment and trade promotion agency of Mauritius. This pavilion in particular will be perfect for medical plastics fans as the co-exhibitors are Natec Medical Ltd, manufacturer of stents and catheters, Moraker Capricorne Ltd, manufacturer of orthopaedic and dental implants and Xtruline Co Ltd, manufacturer of personal protective equipment, medical tubings, and moulds.

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MED-TECH INNOVATION EXPO

The Med-Tech Innovation Conference is in association with Medilink UK and will have speakers across the two days. The speakers cover everything and everyone from giving advice and insights to start ups to discussing the health inequalities for women.

A seminar everyone is looking forward to is the Keynote Speech for Day 2; Karen Taylor, the Director of Deloitte, will discuss the innovation in diagnostics.

One of the first speakers on Wednesday, Ashley Sayed, talks about manufacturing Industry 5.0 and using sustainable modular automation in the healthcare sector. Learning about new technology will always be a must with manufacturers in the healthcare sector. Whilst Industry 4.0 shows us the importance of smart manufacturing and automation, Industry 5.0 looks beyond efficiency and productivity, creating a foundation to more sustainable and flexible manufacturing.

Introducing Health-Tech is sponsored by Hessen Trade & Invest and is going to be full of great speeches throughout all of Wednesday and Thursday.

This conference is great for start-ups and people who need advice on how to progress their company. There is a lot of training and ‘how to’ themes throughout the two days, for example there is “MedTalk Podcast Live - Addressing the Challenges Presented by the Current Medical Device Regulatory Environment” and “How to Transform the Customer Experience: The Medical Device Market Meets E-Commerce”.

Also, on that stage will be PITCH @ Med-Tech Innovation. PITCH is the startup competition at Med-Tech Innovation Expo that brings together the world’s leading, early-stage Medtech start-ups for a live on-stage accelerator-style pitching session.

INJECTION MOULDING There are so many markets for attendees to choose from; one of the biggest plastics markets not to miss is injection moulding specialists.

Medical Moulded Products are an injection moulding company that specialise in bespoke designs. Their machines range from 50 to 150 tonnes to make spatulas, mixing bowls, syringes, dispensers, and many other designs.

Another specialist you can expect to see is Sovrin Plastics. They provide injection moulding and manufacturing services for the supply of precision plastic components and full assemblies to the medical industry.

Boddingtons is another one of the experts on show this year. Their medical device facility offers Class 7 cleanroom manufacturing for the productions of Class 1 and Class 2 medical devices.

The CEO of Boddingtons, Andy Tibbs said: “Boddingtons is really looking forward to showing how we can exceed visitor expectations for manufacturing services, and for the production of Class 1 and 2 Medical Devices. Our investments in MDSAP quality systems and in Class 7 clean

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There are three pavilions this year; the Mauritius Pavilion, Medilink UK Pavilion and new to 2022, there is the Italian Pavilion room technology have exceeded £6m over the past five years. Come and see us at the NEC, June 8-9th.

We can help you achieve your medical manufacturing goals.”

TUBING AND CATHETERS Another huge market is tubing and catheters. This market will always be in high demand in the healthcare sector and companies are constantly working on new products to showcase.

One of these companies is Xtruline Ltd; they have flared tubing, extrusion tubing, catheter dispenser packaging and many more. Their tubing diameter ranges from 0.2mm to 5mm and have process capabilities for different polymers; polyethylene, polypropylene and polyamides.

MED-TECH AWARDS There are so many things to look forward to at the Expo, including the Med-Tech Awards. This year’s ceremony is going to be particularly exciting as there were so many amazing nominations this year that there are now two extra awards to be given away: Sustainability Award and Special Recognition Award – Response to Covid-19. The winners will be announced at the black-tie event, hosted by The Chase’s Paul Sinha.

For more information about visiting Med-Tech Innovation Expo, visit www.med-techexpo.com.

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COVER STORY

KEVIN LADOW, MEDICAL PRODUCT MANAGER USA WEST AT JUNKOSHA, REVIEWS THE NEXT STEPS NEEDED BY END USERS AS PATIENT CARE CONTINUES TO TOP THE AGENDA FOR HEALTHCARE SETTINGS.

The Journey Towards Intelligent Catheters T

he journey towards intelligent catheters is an important one, both from the clinician’s and the patient’s perspective.

Their development is necessary to accelerate the shift from costly, burdensome surgical treatments towards cost-effective and minimally invasive interventions. To treat a wider range of patients and types of disease, it is crucial to have smaller and more flexible, high signal capacity catheters at the surgery team’s disposal. This type of tool will provide surgeons with the highquality imaging to precisely identify patient anatomy to help maximise the safety and efficacy of the procedure.

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Decreasing the size and increasing the flexibility of these catheters will help the physician more effectively navigate demanding patient anatomy, resulting in efficient and accurate devices or therapeutic delivery. Together, these advancements result in tangible, direct benefits for the patients, such as greater access to safer, less invasive procedures, with quicker recovery times.

Intelligent catheters, with new diagnostic and therapeutic capabilities, will enable the development of new, advanced therapies for diseases that are currently treated by complex surgical procedures. This will allow for more individuals to be treated and minimise risks, improving quality of life and reducing death rates for these patients. Intelligent catheters will allow a wider range of functions to be integrated into single, small devices in a cost-effective and industrially feasible manner. Since catheter-based procedures are typically done on an outpatient basis, they do not require an expensive OR suite or recovery in a hospital bed.

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COVER STORY

To this end, solutions such as Multi-Filar Cables and Multi-Channel Transmission Cables (MCT) represent a breakthrough in the design of medical device cables that take us closer to the next generation of these important devices.

The innovation behind the Multi-Filar active cables is significant. Multi-Filar cables can have a capacity of up to 60 lines and are designed to provide not only increased functionality but also more signals into formerly inaccessible areas of the body.

Using Junkosha’s PTFE lamination technology, single strand configurations are joined into a Multi-Filar assembly that can be used in electrophysiology catheters for applying pacing and recording protocols from inside the heart, ablation and balloon ablation catheters for atrial fibrillation as well as cardiac mapping.

The Multi-Filar technique also allows for easier assembly of the signal or power wires into the final medical device, making the overall manufacturing process simpler and more cost-effective.

The manufacturing process is complicated, which Junkosha has refined by being able to accommodate the specific requirements for the final product design.

For example, each individual strand can be colour coded in the material, in accordance with specific industry standards or to make connection operations more simplified in downstream operations. The bond strength between the individual strands can be adjusted to maximise strength for challenging assembly conditions or optimised for difficult separation processes. MultiFilar configurations allow for joining dissimilar single strand alloys together in one package. This flexibility in alloy selection is suited for applications like thermocouples, micro cables that need a high strength member for load bearing or assembly operations and electrochemical process cells.

MULTI-CHANNEL TRANSMISSION CABLES Multi-Channel Transmission (MCT) cables are another step towards intelligent catheters. MCT represents a significant improvement on existing shielded twisted pair, coaxial and Flexible Printed Circuit technology and enables new data-rich signals to be utilised in therapies such as Intracardiac Echocardiogram, Ultrasound Endoscopy and Intravascular Ultrasound (IVUS).

Existing catheters use shielded twisted pair or coaxial constructs to support signals along the device. This established technology has driven advances in catheter design and facilitated the delivery of many essential interventional, intervascular diagnostics and therapies. However, the progress towards miniaturisation and flexibility has been hampered by the standard coaxial approach which comprises a core conductor, insulation, and a shield wire.

Physics and electromagnetics have prevented the development of smaller cables and have inhibited catheter flexibility.

In contrast, the new MCT cable design includes four times the amount of signal lines per individual cable, while preserving signal to noise performance. This is thanks to Junkosha’s shielding/grounding design. Whereas the traditional catheter requires two coaxial cables to run in parallel carrying two individual signal streams, MCT enables multiples of four signals to be brought together in one cable.

Early prototypes have achieved a 32% reduction in the size of the cable, a critical factor in the attainment of future procedures within narrower vessels.

The MCT approach also provides a greater degree of flexibility compared to the existing approaches which promises major advances in the scope of medical procedures, especially within endoscopy. Overall, this innovation addresses the mutually exclusive needs of small size and signal integrity simultaneously.

This in turn unlocks opportunities for catheter manufacturers to deliver valuable, previously unrealised options, to clinicians.

As the requirement for smaller and smaller devices increases for a wider variety of therapies, the need for innovations like the MCT solution become paramount to enable them.

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LOOKING AHEAD The pace of change in the medical device sector is increasing continuously. An example of this is the development of mapping catheters, which are used during cardiac and electrophysiological therapies. Mapping catheters help physicians to discover and evaluate the electroanatomical layout of the heart and surrounding area. Previously believed to be impossible, catheterbased solutions are now available to accurately pinpoint problems within blood vessels and the heart.

Interventional procedures utilising intelligent catheters rather than highrisk surgery will allow medical teams all over the world to decrease the risk to all patients, decrease recovery times, and to develop new therapies to heal diseases that until now have been impossible to treat.

As the requirement for complex catheter-based procedures increases, the need for innovations such as the Multi-Filar Cables and the Multichannel Transmission Cables become paramount to enable them. Solutions such as these are continually pushing the boundaries of what is possible with minimally invasive devices and intelligent catheters, unlocking opportunities for OEMs to deliver improved patient outcomes, quicker recovery times, and lower costs of care. These solutions will be key to expanding the capabilities of medical teams around the world, helping reach maximum levels of medical quality and patient care, even in areas where, traditionally, medical resources have been scarce.

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COVID HEALTH

TEXAS MEDICAL TECHNOLOGY HAS BEEN BRINGING PPE TO CANADA DURING THE PANDEMIC. OLIVIA FRIETT HAS SPOKEN TO TEXAS MEDICAL TECHNOLOGY TO LEARN MORE ABOUT IT.

Protecting the nation T exas Medical Technology, a manufacturer and distributor of medical supplies, is partnering with Indigenous Medical Industries Canada (IMIC).

They’re building a Personal Protective Equipment (PPE) factory on an Indian reservation in Canada to produce medical equipment that the company and community feels is severely lacking.

IMIC was founded to bring healthcare to Canadians. During the pandemic, the local governments were struggling to protect the communities, so IMIC stepped in to help. Texas Medical Technology specialise in the sale and distribution of medical equipment at low prices.

Omri Shafran, CEO of Texas Medical Technology said: “I think the pandemic provided a huge mirror and showed each country a reflection of their preparedness. With no ability to protect themselves, healthcare providers are dependent on China for PPE. It creates a very fast race between all countries to become independent, from the perspective of PPE. “These communities deal with many issues including Covid like lack of drinking water, food security, access to timely health care, etc. We hope to improve at least one of them i.e. spread of Covid and the overall need for PPE in their communities.”

IMIC has stated that it is aiming to provide essential medical clothing, PPE and devices to not just the First Nation, but all Canadians. The use of disposable surgical gowns, shoe covers, PPE kits, digital thermometers and PPE safety machines will help keep the Covid cases at an all-time low.

With sustainability being such a huge topic today, choosing the right fabrics is no easy feat. “We are going to use a very innovative product, for example, a new coat for the SMS with copper. This protects the fabric for a longer time and kills the virus once it hits the surface.” Shafran said. “We are very aware and care about our planet, so therefore we use SMS fabric. We are going to incorporate more environmentally friendly products in the future.”

They believe that Canada is one of the most innovative markets in pushing their indigenous communities and in helping them have equal opportunities to enter the job market. In addition to helping protect the nation, 10% of the profits of the joint venture will go towards helping Canada’s Indigenous populations further improve their overall access to healthcare.

Texas Medical Technology has also shared with MPN that they are hoping to bring more medical products to the community in the future: “We are going to bring very innovative products to the Canadian market. We have a lot of Israeli startups, for example, which are looking to sell their products in Canada—as well as in the US. We are going to present an innovative diabetic skin care product as well as innovative female hygienic solutions.”

In addition to helping protect the nation, the factory will create many new job opportunities.

Copper has been shown to have antibacterial properties, meaning it’s a popular choice for PPE. The use of SMS (spunbond-meltdown-spunbond) fabric is favoured for face masks as it has great water repelling capabilities.

These communities deal with many issues including Covid like lack of drinking water, food security, access to timely health care

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COVID HEALTH

MICHAEL BUTLER, KEY ACCOUNTS MANAGER AT EMERSON SHARES THE STORY ON HOW THEIR BUSINESS ADAPTED TO THE PANDEMIC.

How one moulder addressed face mask shortages…

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t the outbreak of the COVID-19 pandemic, governments, military establishments and healthcare systems everywhere were scrambling to locate suppliers of personal protective equipment (PPE) after demand skyrocketed in spring 2020.

In Northern Ireland, the situation was no different, as Health and Social Care Northern Ireland (HSCNI) confronted the critical shortage.

Northern Ireland’s health minister, Robin Swann, said: “The demand for PPE in the first surge of the pandemic placed tremendous strain on the health service. We had to urgently consider how best to meet the challenge of protecting our health and social care staff while safely treating COVID-19 patients.”

To fill the supply gap, HSCNI turned to the region’s manufacturers.

Quality technician Lisa McBride (below) demonstrates Denroy products to economy minister Diane Dodds (left) and health minister Robin Swann (second left). Chief executive of Invest NI Kevin Holland and chief executive officer of Denroy Group Kevin McNamee.

At about the same time, Denroy Group, based in Bangor, Northern Ireland, a major designer and producer of injection-moulded products for aerospace, medical, automotive and hair-care products, experienced a significant contraction in its aerospace business due to the pandemic. Seeking ways to redeploy unused engineering and production capacity, Denroy responded to HSCNI’s request and obtained approval to rapidly tool up, produce and deliver more than 1 million medical face shields to HSCNI for use by frontline medical workers. During the summer and fall of 2020, the company also decided to develop, produce and market a consumer-focused face mask, called the Bubl. Made of clear, moulded plastic, this washable, reusable mask features two circular filter ports that contain prefabricated filter elements made of layered, nonwoven fibres. The design allows users to replace the filter elements with new elements every few days.

Medical and clinical personnel in contact with COVID-19 patients require a greater degree of protection than typical surgical masks provide. Such protection is provided by medical-grade face masks that combine a leakresistant face seal and highly effective filtration of airbourne droplets and particles. CE standards define two types: FFP2 face masks provide a minimum of 94% particle/droplet filtration with a maximum outside air leakage of 8%, while FFP3 masks provide a minimum of 99% particle filtration and maximum leakage of just 2%.

“Designing a high-grade medical face mask is all about balance,” explains Denroy’s CEO Kevin McNamee. “To attain BSI and CE approval, the mask must pass strict testing criteria on filtration, breathability and internal CO2 levels. In addition, it must also provide the highest possible level of comfort and visibility and be simple to fit and remove. Of course, balancing these factors is challenging, since a minor change to improve on one requirement can have a significant effect on others.” He credits medical and clinical experts, together with HSCNI procurement experts, for the “invaluable” advice that helped Denroy finalise the design of the Denpro FFP3 medical face mask.

Instead of the typical FFP3 mask designs that rely on a heat-formed shell made of filter material, the Denpro mask is built around a lightweight, injection-moulded frame that includes holders for four user-adjustable elastic straps. A soft filter “cup” made of four nonwoven fabric layers is bonded onto one side of the frame, while a comfortable, face-hugging thermoplastic elastomer (TPE) foam seal is bonded to the other. The combination gives the Denpro mask a great fit, all-day wearer comfort and plenty of highperformance filtration capacity.

MANUFACTURING CHALLENGES Because of the COVID-19 emergency and the urgent need for PPE, McNamee says that the timelines for every aspect of the Denpro mask development were dramatically compressed.

According to McNamee, “The FFP3 medical mask development, CE approval, tooling, production equipment design and establishment of a new production facility were all conducted at a rapid pace, with the product moving from concept to production in five months. The FFP3 factory is now fully operational with an annual capacity of over 10 million Denpro masks.”

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MICROMOULDING

AN INSIGHT INTO WHAT MICROMOULDING IS BY AARON JOHNSON, VICE PRESIDENT OF MARKETING & CUSTOMER STRATEGY AT ACCUMOLD.

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t is easy when looking at the production of micro plastic parts and components to become overly focused on the intricacies of the micro moulding process per se.

Micro moulding is an exceptionally difficult discipline to master, and very few companies in the world have done so to the point where they can manufacture geometrically and dimensionally accurate parts and components repeatedly in the multimillions.

SMALLER,

GREENER, EXTRA

To be able to do this requires a heady mixture of technological capability and extraordinary levels of experience and expertise, especially when working with medical OEMs for whom the end-use micro moulded parts and components are often safety critical. Failure is not an option!

Micro moulding specialist companies work as product development partners with their customers, in many instances translating design intent into reality via a knowledge of required process steps between design conception and final manufacture. This means having knowledge and understanding of design for micro moulding (DfMM), micro tool fabrication, micro moulding, and micro automated assembly. Parts must be designed with manufacture in mind. This is fundamental in micro moulding where the laws of moulding as generally understood are stretched and in some instances turned on their head, and the vagaries of tooling and assembly when manufacturing tiny parts are many and varied.

Therefore, for optimal product outcomes, representatives from all departments need to be present and influential at the conceptual design stage to avoid costly and time-consuming re-iterations later in the product development process.

And so the absolute must is that a micro moulder has to be truly vertically integrated, with every step of the design-to-market process housed under one roof. That way

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interdisciplinary teams can easily integrate and work together to optimise the process.

So much for capabilities and vertical integration, but what is also needed for successful micro moulding outcomes is a team with exceptional knowledge and experience, able to think on the fly, and create scenarios that break down the restrictions that less experienced moulders would see as prohibitive to project success. The micro moulding space is a dynamic place, and the challenges in terms of exacting applications are an everyday experience for companies such as Accumold. It is a combination of technological capabilities, expertise, and a passion to succeed that drive innovation for customers.

But beyond such supplier selection considerations, it is important not to lose sight of the non-process focused / team focused elements that are required to ensure a successful micro moulding initiative.

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MICROMOULDING

WHAT DO WE MEAN BY THIS? Well put simply, there is a vast difference between a micro moulder that can make you one perfectly formed micro moulded part, and one that has the scalability and sustainability to ramp up production volumes to the multimillions over a protracted period of time, moving as such from your product development partner to your long-term manufacturing partner.

In a sentence, is the infrastructure of the micro moulder you plan to work with big enough to support your volume requirements over an extended period of time? Some customers require millions and millions of parts with a continuity of supply running over many years. Without the physical space needed to accommodate such scale of supply and the associated manufacturing cells etc…, then your chosen partner may not be able to fulfil your expectations.

Also, to sustain supply over many years, you need to be persuaded of the robustness of the micro moulder that you are dealing with. How long have they been in business, how deep are their pockets, can they survive recessionary (or pandemic-associated) downturns?

The amount of time that a micro moulder has been in business should give you some reassurance here. But beware, some suppliers may boast a long pedigree in precision engineering, but this is very different from a long pedigree in micro moulding and actually manufacturing micro plastic parts and components. For example, a company with decades of experience in micro tool fabrication but only a few years of experience of micro moulding is very

Interdisciplinary teams can easily integrate and work together to optimise the process

different from one that has over 30 years of experience of both.

Another thing to do is to have a look at a micro moulder’s published turnover figures. This will shine a light on whether the micro moulder you are considering working with is operating at a significant enough scale to survive unforeseen economic pressures.

Only with decades of micro plastic part production under its belt will a supplier have the experience, strength and breadth of knowledge to tackle the most exacting of customer applications. Yours does not want to be the first project of its kind that your supplier deals with.

Ask for evidence of longevity of manufacturing and look for evidence that your supplier has significant experience with projects such as yours.

Ultimately, medical OEMs need to constantly be aware of the timeline that exists when looking at the design and development of a particular part or device and consider the total cost of ownership. Being able to take a design to a prototype run is very different from looking at the full life cycle of a device from design, trials, to full manufacture and the change management considerations in the life of a product.

Change management alone during the life of a medical device requires that medical OEMs work with micro moulders that have the scale and headroom internally to take into consideration how an adjustment to a device will impact processes, systems, personnel associated with a particular project. There must be a process for planning and testing change, a process for communicating change, a process for scheduling and implementing change, a process for documenting change and a process for evaluating its effects.

All of this plays to the fact that when initiating a micro moulding project, medical OEMs need to consider the long game, and realise that the micro moulder that they work with could be their partner for years and should have the wherewithal to grow and adapt over the lifecycle of a product.

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INDUSTRY 4.0

NEIL BALLINGER, HEAD OF EMEA AT AUTOMATION PARTS SUPPLIER EU AUTOMATION, DISCUSSES THE CHALLENGES FACING THE SECTOR AND HOW RECONDITIONED AND OBSOLETE COMPONENTS CAN HELP.

Overcoming supply chain disruptions

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in medical device manufacturing

he COVID-19 pandemic brought unprecedented challenges for the medical device industry, from skyrocketing demand for respirators and personal protective equipment (PPE) to staff shortages. Since the second half of 2020, another major challenge has been procurement. A combination of pandemic-related factors, sociopolitical instability and a major semiconductor shortage has led to an unprecedented supply chain crisis — a challenge that is particularly felt in safety critical sectors like medical device manufacturing.

Due to the extensive review process for each device, this sector usually needs long lead times for products to get approved and delivered, so even a minor disruption can result in major delays. This is the case for components used in the final products, but also for automation parts in core machinery on production and assembly lines. For example, equipment and processes will have to be re-qualified in case of major maintenance or substantial modifications to the production lines.

THE NEED FOR COMPLIANCE Medical device manufacturers must navigate an abundance of red tape to ensure regulatory compliance.

For instance, compliance with the European Medical Device Regulation (EU MDR) is compulsory for companies that sell their devices in the EU. When it comes to a medical device manufacturing plant, the initial design of production lines needs to be validated by the relevant authorities, and almost every change on the line may require additional inspection and validation.

A validation master plan (VMP) outlines the necessary steps when qualifying a facility for producing medical equipment, as well as a detailed process for maintaining a qualified facility. By following a VMP,

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manufacturers can be sure that their processes will produce only conforming items.

This sets medical device manufacturers up for success, but also requires them to adhere to strict guidelines. For example, if a component fails and is in short supply, it cannot just be replaced with a compatible one — the same part will have to be sourced. This can become a regulatory nightmare if the component is obsolete and no longer produced by the original equipment manufacturer (OEM), or if the latter is impacted by supply chain disruptions and unable to produce and deliver as usual.

COPING WITH DISRUPTIONS In the short term, the best way to combat the negative consequences of shortages is keeping track of stock and increasing inventory whenever possible.

On the other hand, investing in supply chain management (SCM) software can be a good long-term strategy to help track inventory, manage shipping, and keep updated on which stocks are decreasing the quickest.

It is hard to avoid obsolescence issues when manufacturing medical devices, but there are some steps manufacturers can take to minimise the impact. In the design phase, design engineers should carefully research the expected lifespan of the components they intend to use, as well as monitor how long these have already been on the market.

For manufacturers who are past the design stage, refurbished components can be a great way to source parts that perform like brand new ones, even when the OEM cannot deliver. An automation parts supplier that specialises in reconditioned and obsolete parts, like EU Automation, can help source the right product regardless of where in the world it is located. They can then ship it in record times, saving manufacturers weeks of costly downtime. However, this should be used in combination with other proactive obsolescence management strategies.

With disruptions continuing to impact global supply chains, manufacturers should take the time to implement a good obsolescence management plan.

Failure to adapt to these challenging times could cost companies millions in unnecessary downtime and replacements.

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Messe Frankfurt Group

15 – 18 NOVEMBER 2022 FRANKFURT / GERMANY

Enabling the impossible!

We know that additive manufacturing offers undreamed-of potential. Only, however, if all the upstream and downstream processes are taken into account – from design to material and quality assurance.

Does your technology contribute to AM? If so, do secure your space in Frankfurt. formnext.com

Where ideas take shape.

DIGITAL HEALTH

JOHN CHRISTIANO, DAVIS-STANDARD, GIVES AN INSIGHT INTO THE FUTURE OF DIGITAL TOOLBOXES.

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A Digital Toolbox Full of Possibilities

igital transformation impacts our lives daily. The multiple features on our phones, the navigational systems in our cars, instant access to information, live streaming of media into our homes; are just a few examples of how the Internet of Things (IoT) has changed the way we live and do business.

Manufacturing operations are extremely complex, which is why digital infrastructure has been slower to occupy this space. As a result, our industry looked inward to strengthen operational efficiency and profitability.

Improvements focused on control systems for the factory floor through automated control systems that improve safety, reduce human interaction, strengthen local data collection using improved SCADA systems (Supervisory Control and Data Acquisition), and access equipment via the internet. These steps served as the initial building blocks for digital transformation within operations.

This movement accelerated as digital technology proved to be more reliable.

Our industry realised the potential and initiatives gained traction. The fourth Industrial Revolution quickly gained popularity. The possibilities and advantages of Industry 4.0 spread around the globe, and today we have the Industrial Internet of Things or IIoT.

The IIoT platform enables the development of new technology by leveraging information from existing control capabilities. Currently, line control systems can display and collect performance information, providing an interface for operating equipment. However, this presents disparate information that is difficult for operators to translate. New digital technology expands this platform by introducing a human factors concept of situational awareness to improve performance while incorporating preventative and predictive tools into our operations. This gives you instant data access, imagery, and connectivity not available with current systems.

The multitude of benefits realised through increased situational awareness provides you with a customised digital toolbox that will both simplify and amplify your operation.

Situational awareness is defined as developing and maintaining a dynamic awareness of the situation and the risks present in an activity. This is based on gathering information from multiple sources from the task environment, understanding what the information means, and using it to think ahead about what may happen next.

The three aspects of information processing include perception, understanding/interpretation, and prediction.

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DIGITAL HEALTH

Perception or gathering of information directly using our senses of vision, hearing and touch, or indirectly through a complex control system involving HMI displays, and interfaces.

Understanding information by combining this data from the production process or equipment with existing knowledge and experience from memory. Information gathered is given meaning. This includes developing an accurate and complete picture of the operation, better informing our decisions.

Prediction and projection into the future, which includes thinking ahead.

This involves predicting what to expect as well as what not to expect.

Situational awareness provides context to the complex data that your team receives from your production environment. It helps your team interpret data, to make informed decisions that result in positive projected outcomes. It makes it possible to transition from a historical perspective of “running to failure” using post-failure analysis to a preventative and forward-looking system using real-time information from your process and equipment.

DS Activ-Check is a custom-designed, cloud-based platform that improves the operator’s situational awareness to enhance extrusion production line performance and productivity. DS Activ-Check leverages systems and strategies offered by the IIoT to increase operator effectiveness, leading to reduced downtime, better product quality, and reinforced operator safety. The configurable platform engine uses analytical tools based on long-term cloud data storage along with process and equipment technology algorithms to help management and production teams identify and improve product quality and line efficiency.

The DS Activ-Check system continuously monitors production line equipment.

The real-time operational data, including KPI (Key Performance Indicators) from the production line PLC or SCADA system, are sent to an edge server inside the plant. The edge server collects, buffers, and encrypts the data before sending the information on a secure Port 443 through a secure firewall. The server is located behind a secure firewall to prevent unwanted access.

The data moving on the secure Port 443 travels over the internet and is stored on the cloud. The cloud refers to servers or computers accessed over the internet and the software and databases that run on those servers.

WHAT ADVANTAGES DOES USING CLOUD-BASED MONITORING OFFER? Information storage and access Data collection and storage capacity is unlimited. Your valuable production data is securely stored and can be used in the future for comparing production performance between lines and plants, optimising production processes, and more.

Connectivity You have the ability to securely monitor your production process from anywhere at any time. This is a force multiplier for your process, maintenance, and operations teams. They will be able to address issues before failure, eliminating lost production. They will be able to identify a specific issue and take corrective action quickly versus spending countless hours trying to determine a root cause.

They can deploy maintenance tasks with all records of completion stored for future reference. They can collaborate and troubleshoot issues in real-time to prevent costly production downtime.

The data storage capacity for a typical SCADA system is limited to 180 days.

After 180 days, the data is lost. A cloud-based system ensures your data is never lost.

Scalability Production equipment can be easily added to the system starting from one line.

In addition, production lines in the plant and from other locations, domestically and internationally, can be included. This is a very important feature for digitally transforming multiple locations.

Analytics running in real-time The cloud platform provides the capability to continuously run software that analyses equipment performance. Using real-time data from your production process, software programmes continually monitor the performance of your operation and provide critical information to key players. This reduces or eliminates unwanted downtime and guides your decision-making with regard to preventative and predictive maintenance items.

As with any new technology, digital transformation is a journey that evolves and develops as it is implemented. The time to take that first step is now, that vital step that opens up a world of efficiency and troubleshooting possibilities for your medical extrusion and/or converting operation.

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SPONSORED

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POROUS PLASTIC COMPONENTS

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The Vyon white room provides a controlled manufacturing environment, dedicated to fulfilling the strict regulatory and cleanliness requirements for components used in their products. Within the white room we have implemented cGMP compliant procedures enabling us to achieve even tighter specifications for contamination-free components.

Drawing upon decades of knowledge in the manufacture of industry-leading porous plastics, combined with advanced materials expertise, Porvair Sciences has established a reputation for delivering outstanding components to OEM and laboratory customers worldwide. Proprietary to Porvair Sciences - Vyon is a highly versatile porous plastic which can be modified

Caption: a range of Vyon porous plastic components and products

to give hydrophilic or hydrophobic properties or enhanced to achieve specific chemical and biochemical separations. Vyon can also be combined with other materials to create application specific composite products.

These and other desirable properties have made Vyon the porous plastic material of choice for healthcare, pharmaceutical and life science companies looking to produce filters, vents, bed supports and sample separation products with a competitive advantage.

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Precision Engineered Shapes and Sizes From simple discs to complex shapes, Vyon® porous plastics can be converted from sheets and rolls to a wide range of custom configurations to ensure secure and long-lasting fit in the final assembled product.

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TESTING AND INSPECTION

MIKE JOHN, TECHNICAL DIRECTOR FOR IRELAND AT THE SEMPRE GROUP, EXPLAINS HOW METROLOGY CAN BRING THE MEDICAL DEVICE DESIGN AND MANUFACTURING PROCESS TOGETHER.

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hile ISO 13485 sets the standard for quality management systems (QMS) in medical device manufacturing, metrology is often treated as an afterthought and simply used to validate products and detect defects at the end of production. The result? It becomes harder to prove consistent quality and the validation process can become fragmented.

DRAWING AND REPORTING Every medical device starts with a concept and a drawing, and a manufacturer must find the best way to convert this 2D drawing into a 3D, functioning product.

Traditionally, this requires engineers to manually outline all the individual dimensions and requirements of the part, creating a ballooned image that they can use to manufacture a final product. A First Article Inspection (FAI) report is a design verification and historic file that provides reported measurements of the first manufactured parts to ensure that it correlates with the drawing, showing that the device functions as intended and meets the application’s requirements.

However, collecting data manually often means this step of the process is time consuming and can introduce human error, which is not an option in this highly regulated industry.

One solution is to automate the ballooning and FAI reporting process where manufacturers can benefit from having a centralised data collection point that enables them to automatically compare ballooned drawings to pass FAI reports. For example, the High QA Inspection manager allows engineers to scan entire drawings, or multiple pages, in one click. It automatically extracts the geometric dimensioning and tolerancing (GD&T) data and critical dimensions, with all the tolerances automatically allocated.

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QUALITY PRODUCTION CAD models are now being created instead of 2D paper drawings and the information contained in these files can also be ballooned using the same software. This data can also be linked into computer numerical control (CNC) machines or another production system to produce the component. As well as proving quality assurance, manufacturers should use data to learn more about their prediction process so that they can review part quality and resolve issues head-on.

As well as reporting, manufacturers can use data and software to make proactive changes on the shop floor during production. For example, a Reaction Plan manager is an automated instruction-based software that analyses measurement data, calculates offset and provides tool correction instruction. If a part fails to meet specification, the software will instruct the operator how to adjust the machine to correct the problem.

When measuring small, intricate components, Original Equipment Manufacturers (OEMs) get the most accurate results quickly when the part under inspection is secured. Fixtures are key when inspecting medical components, such as syringes, because they provide 360-degree access and keep them in place without exerting too much pressure and damaging the part. Therefore, they facilitate ISO 13485 compliance because every part is measured in the same orientation, minimising inconsistency.

REPRODUCIBILITY Accuracy is critical to medical device compliance, so knowing that all measurements are repeatable and reproducible is essential. After parts are produced, manufacturers can assess gage repeatability and reproducibility data (GR&R) to certify that the measurement output is the same value as the input, and that the same measurements are obtained under the same operating conditions over a set period.

Integrating highly accurate CMM and metrology systems is a good starting point for ensuring repeatability. For instance, the Micro-Vu Vertex has a 2-micron accuracy and a 0.1-micron resolution, and it facilitates automated reporting, including GR&R documentation.

Metrology specialists like The Sempre Group can provide an endto-end turnkey solution, assessing quality testing needs and making recommendations throughout the manufacturing process. A good partner will not only supply the measurement system, but assist with the programming, validation and reporting that comes with it.

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TESTING AND INSPECTION

THOMAS MILNES, INDUSTRIAL DESIGN CONSULTANCY LIMITED, HIGHLIGHTS SEVERAL MISCONCEPTIONS RELATED TO INSPECTION PROCESSES DURING MEDICAL DEVICE DEVELOPMENT.

MISCONCEPTIONS BETWEEN DESIGN AND MASS PRODUCTION

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o keep up with the demand of high standards and fast time to market in medical device development, it is necessary to ensure development methods are optimised. Harnessing inspection processes during the development phase can ensure a smooth transition between design and production.

1. THE MORE INSPECTION, THE BETTER THE COMPONENTS WILL BE It may seem logical to designers that including a more detailed component specification will lead to more thoroughly checked but taking this approach can lead to unwanted drawbacks: - Increased inspection time – The more dimensions/inspection points specified on the technical drawings, the longer the parts will take to inspect.

Given some components can go through many samples before finalisation, removing unwanted inspections should reduce development time.

- Specification changes – Due to the complexity of production manufacturing processes and plastic materials, it may be that initial component samples are not completely accurate in all areas.

- Prioritisation of the specification – If the specification is over-extensive for each component, the manufacturers may not know which areas to prioritise.

2. WIDENING TOLERANCES AND COMPONENT SPECIFICATIONS WILL REDUCE PROJECT COSTS Designers will sometimes focus on loosening tolerances and reducing testing to try and speed up development and save money. Certain things should be considered before widening part specifications: - Design constraints - Considering the design inputs will set constraints for the design such as size and weight, when all these constraints are laid out, defining the individual component specifications should be easier. If defined correctly, there will be less chance that these specifications will need revisiting later.

- Tolerance stack-up - If tolerances are loosened without consideration of the device’s intended function, the risk of device failures may increase.

Tolerance stack-up calculations should help determine which can be loosened.

- Manufacturing capabilities – Liaising with the manufacturer could determine where the tolerances can influence cost.

- Material capabilities – For moulding processes, the material itself can limit tolerance capabilities. Raw material suppliers are generally aware of the limitations of their materials, and they may have alternates available.

- Complex interactions – Inspection can be a vital tool in reviewing components, and engineering calculation combined with material research can help designers understand the interactions between parts.

However, testing real part interactions could highlight any potential issues with interactions.

- Complex properties – Plastics and their properties do not always easily translate to theory, these issues should be picked up by ageing studies but may not be picked up by theoretical approaches.

Inexperienced medical device designers can rely too much on theory; inspection can provide information where testing does not, and vice versa, so using both inspection and testing methods helps give the device the best chance of moving quickly through the development phase.

Inspection can be a useful tool to ensure successful development of medical devices when used correctly.

Ensuring component specifications are defined realistically and with justification, and at the same time understanding the limitations to inspection, should translate into more successful projects.

Ultimately, defining the component parameters well initially, should mean less component and specification modifications, this can directly improve overall product quality, reduce project cost and ensure the project is delivered on time.

3. INSPECTION IS SUFFICIENT ON ITS OWN, THERE IS NO NEED TO TEST There is a wealth of potential testing methods for many scenarios, and it should be evaluated whether there is a reason to test a device or individual components during early development. If inspection is the sole method of sample analysis during development, certain elements could be missed: - Unseen imperfections – Components may have imperceptible imperfections which influence their properties, such as contamination, preconditioning influences, moisture absorption etc.

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TESTING AND INSPECTION

KISTLER GROUP CREATES EQUIPMENT FOR INSPECTION OF PARTS THAT CAN BE USED IN THE MAKEUP OF MEDICAL DEVICES. MEDICAL PLASTICS NEWS SPOKE WITH THEM AT MD&M WEST TO SEE WHAT DEVICES THEY HAD ON SHOW.

Passing the test K

istler is well-known for its range of process monitoring and measurement solutions for medical device manufacturing.

The devices that were showcased at MD&M West were no exception.

‘this is what we predict the problem will be just based upon estimations of what the specific conditions might be’.”

When looking at the machines, Curtis Krick, plastics & advanced manufacturing manager at Kistler Group, said: “What you want to do is see and understand how the faults occurred. So, if you have a root cause you can then identify and say, ‘I can re-simulate these’.

Once you reset and evaluate the faults, then you’re able to put the criteria in to keep it from happening again. And you’re able to control the process.

“You want to know the specific conditions that caused this problem. We have systems that would be considered AI because they do have intelligent learning capabilities and these models say,

Process monitoring systems play such an important role when creating medtech devices; they can prevent something going wrong, ensure there are no faults, make the manufacturing more efficient and avoid recalls.

Kistler’s machines help manufacturers meet the requirements of the healthcare market, making production a lot more efficient.

The company showcased ComoNeo, which supports injection moulding.

Kistler claims the system is more accurate than before and supports users throughout the entire validation process, due to its newly added features.

The user management and trail functionality help maximise safety and security whilst its extended user interface boasts a reliable transmission of data to the injection moulding machine.

The test automation for continuous materials is critical for manufacturers and this is where the company feels KVC 621 has its benefits. This universal video measurement system focuses on high, individually adjustable speeds. Kistler insists this machine achieves reliability and operates with a processing speed of up to 6000 measurements per minute.

“You can know exactly where something was wrong or off, you can then have all that information. We can backtrack to what was wrong with those parts. So, you can go back and look at all of that and see this part was fine and this one was bad.” Kyle Fischer, IPC field sales engineer at Kistler Group, explained. “And then you have the exact data, so you can see exactly where you heard it was bad, or if it took more force or anything to assemble a little, you can go back and say ‘all right, you guys did this wrong, fix this’.”

Kistler’s aim is to ensure that the whole production cycle is covered. They were showcasing machines that can test every element from design to manufacturing the finished product, making the manufacturer’s job much simpler.

Stephan Vogel, head of international business development at Kistler Group, said: “You industrialise it through the process, validation, qualification, everything, and then you start production. If we need to have vision inspection or if they want more properties or different properties, we offer all of that too.

“So, we have all the interfaces that are necessary today with all the industrial feed passes; you get it all out on one hand with one consistent data quality and data handling which is the biggest advantage that our customers have. In process monitoring, it’s not only the product testing, process monitoring, but the whole value chain of the selection.”

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K 2022 I 19-26 October 2022 I Hall 15

HIGH PERFORMANCE

SOLUTIONS FOR

LEADING MEDICAL APPLICATIONS.

Precision meets speed and cleanliness. The all-electric ELION is the ideal injection molding machine for the cost-effective mass production of consumables for in-vitro diagnostics, primary packaging and drug delivery systems, as well as healthcare and medical disposables.

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Clamping force range 800-2800 kN

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Cleanroom equipment up to class ISO 5

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Perfect precision and reproducibility

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Excellent overall equipment effectiveness

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Added productivity boost with NETSTAL Smart Operation (available as an option)

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Leading price-performance ratio

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Worldwide customer service

More details on www.netstal.com

NEW SERVICE Machine calibration according to ISO/IEC 17025:2017 on-site at customer’s premises

PACKAGING

MARK FOULGER, COMMERCIAL DIRECTOR OF FOOD PACKAGING COMPANY PFF, HAS SHARED THEIR JOURNEY ON CREATING PFF HEALTH TO HELP COMBAT THE CORONAVIRUS

P

PACKING UP THE PANDEMIC

FF Health is part of PFF Packaging Group, a privately owned food packaging manufacturer in the UK. During the Coronavirus pandemic, PFF used its expertise in the food sector to meet the increased global demand for Personal Protective Equipment (PPE). In early 2020, PFF won a Department of Health and Social Care (DHSC) contract to manufacture polythene aprons for frontline NHS staff and social care workers. PFF created over 100 jobs for the duration of the contract and invested more than £2m in custombuilt machines to manufacture the aprons, ramping up production to 24 hours a day, seven days a week.

Polythene aprons, along with other PPE items, became, and remain, a vital source of protection for health workers. Once they were up and running, PFF began to look for greater efficiencies and scoped out a blueprint for bespoke apron manufacturing machinery.

Collaborating with British machine manufacturer Hanbury-Autogil, PFF commissioned two specialist machines - the fastest in the world, designed and manufactured in the UK. These machines now form the backbone of their manufacturing capacity. To date, PFF has supported the UK Government and DHSC, having manufactured just under 400 million aprons.

Traditionally polythene aprons contain little recycled material and PFF Health is seeking to change this. PFF is using our expertise and that of their partners in a major project to significantly increase the recycled content of the aprons we supply.

PFF Health is working with several medical device businesses to design both standard and bespoke solutions for medical product components and packaging solutions. Using their expertise gained over many years in the food industry, they will re-design products to reduce the weight, and therefore the quantity of plastic required. Crucially, they must ensure that product performance is not compromised, and this is where they work in partnership with their clients. PFF has established a Regulatory Project Group and will work with businesses to ensure the correct quality standards are met.

Where an end product requires sterilisation, samples can be test-sterilised and examined. The polymers used will be influenced by the sterilisation method. PET/rPET is not ideal if the product is to be sterilised in a high temperature autoclave. A better polymer in this instance might be PP. Polypropylene itself is a good all-round raw material and it is no surprise that many medical components and packaging are manufactured using it. The company claims that their designs and achievable weight savings can range from 10% to more than 40% and this can become a significant contributor to the overall objective of the NHS to become net zero.

The NHS has two targets for its carbon footprint. Firstly, for emissions that it can directly control, it will reach net zero by 2040 and will achieve an 80% reduction by 2028-32. A broader target ‘NHS Carbon Footprint Plus’ focuses on the wider carbon footprint of the NHS and will directly impact medical device manufacturers, both the devices they produce and the carbon impact of freight transport. This target states that the NHS will reach net zero by 2045 with an ambition to reach an 80% reduction by 2036-39.

This means that going forward, the UK can no longer simply source products from around the globe while ignoring the carbon impact of doing so. The impact of the pandemic, as well as previously unthinkable events such as the blockage of the Suez Canal, have starkly exposed the UK’s supply chain vulnerabilities.

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AS PIONEERING k-online.com/pioneering

Messe Düsseldorf GmbH P.O. Box 10 10 06 _ 40001 Düsseldorf _ Germany Tel. +49 211 4560 01 _ Fax +49 211 4560 668

www.messe-duesseldorf.de

Q&A

4D BIOPRINTS HAVE ANNOUNCED THEIR NEW DISSOLVABLE IMPLANTING DEVICE. MEDICAL PLASTICS NEWS CAUGHT UP WITH PHIL REEVES, AN ADVISOR FOR 4D BIOPRINTS, TO GET AN INSIGHT ON WHAT THEIR DEVICE DOES AND HOW IT’S DIFFERENT TO THE REST ON THE MARKET.

BRINGING IMPLANTING

to a whole new level Could you tell me a bit about 4D Bioprints?

Implant products cause swelling, they cause tissue rejection, they slow down the healing process and Andy [Professor Andrew Dove] wanted to do something differently. So, from the ground up, he decided to create a new polymer, and I think that was the thing that was quite a revelation to people.

is a leading authority on degradable polymers. He was motivated to develop the material because existing incumbent materials cause problems when they are implanted, such as a burst release of acid.

When they told me I laughed at them and said, that’s not possible because it’s all toxic and horrible and you’d never put it in the human body. And then they proved me wrong.

It certainly shocked me when they told me what they were doing.

His motivations were really interesting. He’s an expert, world renowned authority in degradable polymers. And he had always questioned why we’re putting materials like polylactic acid and polyglycolic acid in the human body.

How is this different to other implants?

When you think about implants, your mind goes to hip implants or knee implants and possibly spinal implants that historically have been made from titanium. And we’re now starting to see a lot of those implants being made from permanent polymers. Once they’re in the body, they’re going to stay in the body until the day that you sadly pass away. Materials don’t need to be permanent because the body can heal itself.

We can still create new polymers and we can create new types of polymers that are fit for purpose. And that’s what he did by formulating what’s ostensibly, a polycarbonate urethane photo curable material. Which up until now, every photo curable material in the market was either based on an accurate rate or an epoxy, which are toxic.

If you look at the existing materials that are used for these types of implants, they all have a narrow window of mechanical property in terms of strengths and elongation and what Andrew, and our chemistry team have done is they’ve managed to extend that window of mechanical properties. We can make resorbable polymers that almost feel like human tissue.

So, I think that’s what has piqued people’s interest in this, is that we’ve not only created a material that you can use with a whole range of 3D printing hardware platforms, but you can use it for implantable devices. And that I think is the really novel and interesting thing.

So, what we have are a range of polymers called bio resorbable polymers. These are polymers that when you put them in the human body over time, they will start to break down and be absorbed back into your body. The problem with the current material, which are things like polylactic acid PLA and PLGA, when they break down the by-products of them are mildly toxic.

Where did the idea come from?

The idea came from research started about 15-years ago by Professor Andrew Dove. Professor Dove is now at Birmingham University but started the research when he was at Warwick. He

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How effective is it?

Our material has so far been implanted into several small mammal models for clinical evaluation. Studies have shown that the material is far more biocompatible than the current best-in-class PLA resorbable polymers.

Our material, which we call 4Degra, has shown to promote cell growth up to 18-times faster than PLA. Our material has far better cell proliferation, far lower rejection from the body. So, I think that’s what has excited the clinical community.

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