MPN NA Issue 14

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NORTH AMERIC AN EDITION

MEDICAL PLASTICS news +

EU MDR COVID-19 TRADE SECRETS AND PATENTS

ACCUMOLD DISCUSSES RISK MITIGATION IN MICRO MOLDING ISSUE 14

Apr/May/Jun 2020

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ADVANCING MEDICAL PLASTICS



CONTENTS MPN North America | Issue 14 | Apr/May/Jun 2020

Regulars

Features

2 Comment How the medtech industry is tackling Covid-19

9 Rising to the challenge Datwyler Pharma discusses the rise of injectables, quality control measures, and personalization

19 Under pressure Trinseo looks at how chemical resistant grades prevent damage to plastics in the fight against HAI

14 What’s trending? Laura Hughes recalls what everyone was talking about at MD&M West earlier this year

20 Are you protected? Knobbe Martens explains trade secrets and patents in the United States

3 News focus 4 Digital spy 7 Therapy area focus: Neurology 10 Cover story Accumold explores risk mitigation in micro molding 24 Back to the future

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CREDITS editor | laura hughes laura.hughes@rapidnews.com head of content | lu rahman web content editor | ian bolland

Editor’s Comment

advertising | sarah livingston sarah.livingston@rapidnews.com

LAURA HUGHES

head of media sales plastics & life sciences | lisa montgomery head of studio & production | sam hamlyn graphic design | matt clarke junior designer | ellie gaskell 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 © 2020 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.

ISSN No: 2632 - 3818 (Print) 2632 - 3826 (Digital) 2

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How the medtech industry is tackling Covid-19

ife as we all know it has changed significantly since the publication of MPN’s last print magazine.

In my most recent editor comment for our European issue, I was discussing my trip to Anaheim, California for the trade show, MD&M West. Travelling across the world and attending exhibitions alongside thousands of people is a far cry from today’s reality. For the past few weeks I have been able to work from the comfort and safety of my own home, however, for many people this is not possible. In the United Kingdom, we have taken to standing outside our front doors at 8pm on a Thursday night to applaud all of our healthcare workers who are risking their lives on the frontline to save ours. Treats and artwork as a sign of our gratitude has also been proudly displayed to all of our key workers, including bin men, those working in supermarkets, and delivery drivers to name just a small handful. I have been amazed at how the medtech sector has really stood up and come forward to help fight the global pandemic. The Food and Drug Administration (FDA) has allowed manufacturers to process medical devices through a fasttrack pathway - Emergency Use Authorization. Through this method, Medtronic has received authorization for use of its ventilator by clinicians and doctors for patients with Covid-19. Additionally, the FDA has relaxed guidelines for companies who are manufacturing infusion pumps, ventilators and clinical thermometers due to Covid-19. By doing this, the organization hopes to increase the availability of these devices, which are in high demand. To name a couple of the medical device companies stepping up to help, 3D printing firm Essentium is in the production stage for a WWW.MEDICALPLASTICSNEWS.COM

protective mask kit to help with the pandemic. This kit comprizes of a reusable 3D printed mask frame and filtration media. Plastics manufacturer, Tessy Plastics, has also begun production of face shields to help with the crisis, and manufacturer and designer, Placon, has increased production across two of its manufacturing facilities to help get Personal Protective Equipment (PPE) to healthcare workers during this pandemic. Other manufacturers who don’t typically produce devices for the medical sector, have also helped produce much needed equipment during this difficult time. Dyson, an extremely well-known family name, received an order for 10,000 ventilators from the UK government. The National Health Service (NHS) in the UK also approved a breathing aid by Mercedes F1. This device was a combined effort between Mercedes-AMG HPP and mechanical engineers and clinicians at UCL. This is a very strange and unnerving time for us all, however, I take great inspiration from the efforts of medtech manufacturers as well as all of those working to help fight Covid-19. I hope all of our readers, and your friends and families keep safe and well.

Dyson received an order for 10,000 ventilators from the UK government.


NEWS FOCUS

From prawns to plastic HOW AN AUSTRALIAN TEENAGER TURNED PRAWN SHELLS INTO A PLASTIC ALTERNATIVE.

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ow to recycle plastics is a hot topic, and something that is being talked about more and more as we see plastic reductions in multiple sectors, including both retail and hospitality. However, the properties of plastic are what makes the material so desirable and suitable for a large range of applications within the medical sector.

prawns and thought what makes their shells look like plastic? Maybe I can take that out and use it some way and bind it to make a plasticlike material.”

Bioplastics is becoming an increasingly popular term; however, these are often very expensive, and this limits its use and practicality. Therefore, a teenager from Australia has come up with a clever plastic alternative.

In an attempt to create a sophisticated, biodegradable bag, Arora extracted chitin, a carbohydrate, and chemically converted it into chitosan. She then mixed chitosan with fibroin, which is a protein in silk and cocoons. This combination created a plastic-like material that was reportedly able to decompose 1.5 million times faster than commercial plastics, and able to completely break down within just 33 days.

When Angelina Arora went shopping one day, she noticed how her mum had to pay for the plastic bag to hold their purchases. She was curious why and asked the shop assistant, who informed Arora that the reason was to deter people from buying lots of plastic bags, and to encourage people to reuse bags and help improve the planet as a result. At sixteen years old, Arora begun thinking of ways to create a sophisticated, biodegradable plastic bag. She experimented with banana peels and various other types of organic waste, however, she found none of these to be successful. Then one day she noticed how similar prawns’ shells were to plastic. Explaining the discovery in an interview, she said: “I looked at

The bag she has designed is flexible, durable, insoluble, and transparent. The concept has already won Arora multiple awards including the Innovator to Market Award in the 2018 BHP Billiton Foundation Science and Engineering Awards, and international recognition at the Intel International Science and Engineering Fair, where she won fourth in the world. She was also awarded a comprehensive scholarship to a prestigious university, as well as the opportunity to share her invention in a TED talk. The legal aspects such as patenting are currently being finalized, although the final prototype is ready for manufacture and commercial distribution. She is currently in talks with manufacturers and companies about the next stages, and as a medical student, Arora hopes to be able to adapt her bioplastic for use as packaging for medical supplies.

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DIGITAL

spy

MEDTECH UPDATE

NEWS UPDATE

WWW.EPSON.COM

Epson robot named ‘Engineers’ Choice’

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obot manufacturer, Epson Robots, has received the Control Engineering “Engineers’ Choice” Award in the Robotics Category for its VT6L all-in-one 6-axis robot. Mark T. Hoske, control engineering content manager, said: “Innovative solutions such as Epson’s VT6L all-in-one 6-axis robot can help solve the most pressing challenges in automation.” According to Epson, the robot is a new entry-level offering for the organization and provides an alternative

for applications that were previously deemed too costly for automation with 6-axis robots. “We are thrilled to receive this prestigious award from such a reputable publication again this year. We strive to offer the most innovative and highest quality robotics solutions to meet the needs of our customers and this recognition underscores that we are continuously fulfilling that goal,” Gregg Brunnick, director of product management for Epson Robots added.

www.terra-drone.net

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HOW DRONES ARE HELPING MANAGE THE CORONAVIRUS

erra Drone, a Japanese commercial drone services company is using its Unmanned Aerial Vehicle (UAV) system to transport medical samples and quarantine supplies in China. The first urban-air transportation that took place specifically for the coronavirus (Covid-19) was conducted in February earlier this

As the air delivery system is automatic and unmanned it significantly reduces the contact between samples and personnel, as well as improving delivery speed.

NEWS UPDATE

www.mnrubber.com

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MRP CONTINUES TO FIGHT HEART DISEASE AND STROKE

hermoplastic solutions provider, Minnesota Rubber and Plastics (MRP), has announced a $150,000 financial commitment over three years to the fundraising campaign by U.S.-based nonprofit organization, The American Heart Association. The event consists of a fitness festival which encourages attendees to be active, and also

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year. On this day, a medical delivery drone flew from the People’s Hospital of Xinchang County to the disease control center of Xinchang County.

pays tribute to friends and family who have been affected by heart disease and stroke. Krista Moffett, vice president of the event, the Twin Cities Heart Walk, commented: “We are thrilled to have MRP’s leadership and commitment to saving lives and changing lives. We are confident that MRP’s significant financial investment will help us raise more

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funds than ever before as we work towards a healthier community." “MRP is proud to continue working with the American Heart Association in its mission of fighting heart disease and stroke as both a supplier of critical plastic and elastomer parts in cardiovascular care as well as now a key donor,” concluded Jay Ward, CEO at MRP.


DIGITAL SPY

REGULATORY UPDATE

www.haselmeier.com

Subcutaneous self-injection device receives medical device master file number

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aselmeier is a solutions provider for subcutaneous self-injection devices. The company has received Master File Number MAF3202 from the Food and Drug Administration (FDA) for its D-Flex product platform - a new generation of injection pen systems for subcutaneous selfadministration. A device master file provides regulatory authorities with information about a material, component or manufacturing process. This file will enable Haselmeier to comply with the regulatory requirements for trading in the USA, whilst also protecting the organization’s intellectual property from potential partners, competitors and customers. It also facilitates combination product approvals for multiple applications using the same device.

With this documentation in place, customers all over the world will be able to leverage the patent-registered D-Flex disposable pen system for their combination product development. This device has the ability to be configured for several fixed doses and therefore aims to bridge the gap between fixed and variable-dose pens. The device also hopes to support pharmaceutical customers from clinical trials through to commercial use.

FDA begins pilot for new 510(k) submission template for device manufacturers

www.futuremarketinsights.com

REPORT SUGGESTS MANUFACTURERS PREFER PLASTIC PACKAGING arket research company, Future Market Insights, conducted research on High Barrier Packaging Films (HBPF) in the pharmaceuticals market. HBPF for pharmaceuticals will reportedly witness a 5% Compound Annual Growth Rate (CAGR)

POINT

www.fda.gov

NEWS UPDATE

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talking

from 2019-2029, with the market expected to flourish in China, India and Mexico. HBPF are popular within this sector because of the oxygen and moisture barrier attributes, which result in a longer shelf life for pharmaceuticals. One of the key messages from

the report was that packaging manufacturers using HBPF preferred materials such as PolyPropylene (PP), PolyVinyl Chloride (PVC) and PolyAmide (PA) to design and manufacture HBPF. In the future, there is predicted to be an increase in the demand for packaging advances such as Modified Atmosphere Packaging (MAP) and Controlled Atmosphere Packaging (CAP). These types of packaging will aim to maintain the atmosphere and internal environment within the packaging and maximize the shelf life of the product as a result.

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What does this pilot involve? This voluntary pilot assessment of the template will include up to nine participants which the FDA claims will provide a representation of the medical device industry. Each participant must submit at least one 510(k) application using the electronic Submission Template And Resource (eSTAR) within three months. Additionally, the FDA has implemented functions such as additional support for mobile devices, the ability to share part-completed filings via email, and also the option to post comments even after the file is converted to a static PDF. Will this new system be difficult to implement? The FDA claims that the structure and content of the PDF filing template are similar to resources already used internally. This allows staff to evaluate submissions more efficiently. Is it too late to get involved? The FDA is currently accepting requests to join this program. However, you need to be willing to submit details regarding the size of your company’s operations e.g. Employee numbers, revenue information, and details about devices the organization plans to file. It is also important to note that combination products cannot be submitted as part of the pilot. After taking part, the FDA will be asking for feedback on the process.

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BPA- and DEHP-free: CYROLITE® acrylics

have just what it takes to save lives.

It’s nice when new life can rely on CYROLITE®: our BPA- and DEHP-free high-performance acrylics are safe to use in medical devices, especially in prenatal and neonatal applications. Additionally, CYROLITE® can be reliably sterilized and is resistant to medical fluids and disinfectants. This has impressed newborns and health-care professionals alike: CYROLITE® easily meets the requirements of USP Class VI, ISO 10993-1, and REACH. We give you all the reasons you need at www.cyrolite.com.


NEUROLOGY

Therapy FOCUS Investigating new ideas HOW TWO MEDTECH COMPANIES ARE TRANSFORMING TREATMENT FOR NEUROLOGICAL CONDITIONS.

Renishaw completes the main part of a multi-centre clinical trial MPN EDITOR LAURA HUGHES CAUGHT UP WITH RUPERT JONES, MANAGING DIRECTOR OF RENISHAW MEDICAL ABOUT THE RECENT STUDY WHAT IS UNIQUE ABOUT RENISHAW’S DRUG DELIVERY SYSTEM? Renishaw’s drug delivery system is intended for long-term implantation, allowing the patient to receive repeated reaccess infusions in an out-patient clinic without the need for additional surgery. FOLLOWING THESE RESULTS, WHAT’S NEXT? Now that the first stage of the trial is over, all patients will receive Cerebral Dopamine Neutrophic Factor (CDNF) in a six-month extension study, allowing for additional data collection for the drug and device. ANYTHING ELSE YOU’D LIKE TO ADD? This is a product we have worked on for many years, taking a multidisciplinary approach to ensure we cover all bases and developing a unique solution to drug delivery to the brain. The ultimate measure of such a device is safety but we also have spent much time on usability and surgical technique, taking feedback from a range of surgeons during its design. However, this trial has also provided us with additional feedback that we hope will allow us to make the usability of our system better by providing an improved user-experience for surgeons, in addition to improving its safety and performance. THE FACTS • 17 patients enrolled in a phase 1-2 clinical study. • Study was looking at CDNF as a treatment for Parkinson's disease. • Allocation for patients was single-blind and randomized. • Initially each patient received either one dose per month of a placebo or six increasing doses of CDNF for six months.

Axial3D explains how 3D printed models add value within clinical discussions CASE STUDY Axial3D wanted to create a 3D printed cervical spine gunshot trauma model, however, the number of small fragments next to the spine made this difficult. Therefore, the fragments needed to be connected to the model in a secure way. By using a Formlabs Form 3 printer, the model was able to be segmented and shipped within 48 hours, and the model was created using a single CT scan. Challenges exist such as the need to segment the model whilst reducing noise from bullet fragments. Additionally, care must be taken around arteries in the patient which could result in major blood loss to the brain. “Having access to a patient’s full-scale anatomical model has allowed surgeons to more accurately diagnose and determine treatment for that patient and in some cases completely change the course of treatment with the additional information given from the prints." – Daniel Crawford, founder at Axial3D.

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shawpak USA Inc. Lusk II, Suite D108, 6440 Lusk Boulevard, San Diego, California 92121, USA T +1 201-961-4740 | F +1 201-891-1412 W www.shawpak.co.uk | E sales@shawpak.co.uk


DRUG DELIVERY

RISING TO THE CHALLENGE RAHUL THAKAR, PHD, TECHNICAL KEY ACCOUNT MANAGER AT DATWYLER PHARMA, DISCUSSES THE RISE OF INJECTABLES, QUALITY CONTROL MEASURES, AND PERSONALIZATION.

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s of May 2019, the global drug delivery systems market was expected to reach US$ 2,302.2 billion in 2027 from US$ 1,243.1 billion in 2018 with a Compound Annual Growth Rate (CAGR) of 7.2 percent from 2019-2027. That was prior to the Covid-19 outbreak and it is unknown exactly how the virus will impact the global market. Up until recently, much of the growth could be attributed to a range of developments over recent years - particularly innovations and advancements in healthcare for the modern patient. The growth of injectables, personalized medicines, and customized drug delivery solutions are just a few trends that have emerged to address industry challenges. CHRONIC DISEASE AND KEY ADVANCEMENTS PROPEL INJECTABLES Increased prevalence of chronic diseases is a significant factor driving demand for injectable biologics. Others include the enhanced convenience, ease of use, and reduced pain of today’s injections, which add to the merits of injectable biologics. However, the growing use of injectables pose certain challenges to drug manufacturers. Compared to oral medications, injectable biologics are less stable molecules and difficult to manufacture. Injectable biologics can also have high viscosity, necessitating unique functionality specifications on parenteral packaging components. QUALITY TAKES CONTROL Since injectable biologics also present a higher immunogenicity risk to patients, authorities’ expectations for quality control are escalating. As such, manufacturing environments must meet the more stringent regulatory and quality demands placed on the primary packaging solutions for these applications. Implementing 100 percent camera inspection minimizes the accidental use of defective components, and utilizing vacuum sealed bags for Ready-to-Use (RTU) components add a layer of security by indicating through the absence of vacuum - if a bag may have been compromised in transport. VALUE-BASED CARE DRIVES PERSONALIZATION Personalized medicine requires unique delivery designs and functionalities. It can take medical device manufacturers two to seven years to commercialize a customized design for prefilled syringes or autoinjectors, depending on the complexity of the design as well as resources, time and equipment.

Moreover, these products would come in much smaller batch sizes than standard drugs, which also requires flexible manufacturing. Though this move from standardization seems daunting, personalized medicine comes with a myriad of benefits. Most importantly, companies will be able to better engage with patients to ensure that drugs are being delivered in more effective ways. Beyond that, personalized medicine offers product differentiation for better brand recognition in the market. This opens the door for patented products and better equips manufacturers guard against ‘copycats.’ DRUG DELIVERY INNOVATION RESTS ON THE DETAILS With these emerging drug delivery trends, companies need to be equipped to catch up or stay ahead of the curve. Companies can implement superior primary packaging and streamline their production processes in cleanroom environments. This allows manufacturers to mitigate contamination threats and even improve personalization and customization capabilities. Careful consideration of what materials and processes are used to develop components like plungers and stoppers, make advancement in syringes, autoinjectors, and other medical devices possible.

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REFERENCES

1 https://www.marketstudyreport.com/ reports/drug-delivery-systems-market-to2027-global-analysis 2 https://www.marketsandmarkets. com/Market-Reports/injectable-drugdelivery-market-150.html

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ACCUMOLD DISCUSSES RISK MITIGATION IN MICRO MOLDING MPN SPOKE TO AARON JOHNSON, VP OF MARKETING AND CUSTOMER STRATEGY AT ACCUMOLD, TO FIND OUT MORE ABOUT RISK MITIGATION IN MICRO MOLDING. CAN YOU EXPLAIN HOW IMPORTANT VERTICAL INTEGRATION IS WHEN LOOKING AT RISK MITIGATION IN MICRO MOLDING? There are many phases in a product development process for micro plastic parts and components, and it takes a coordinated team of experts in design, materials, tooling, molding, validation, and assembly to successfully manufacture customer parts at volume. When working in a micro manufacturing environment when tolerances are measured in microns, it is critical that all involved in the product development process maintain an obsessive focus on mitigating the risk of non-adherence to these tight tolerances, and it is hugely advantageous that all team members are under one roof. Having each “department” in one place eliminates issues associated with outsourcing any part of the

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product development process, as achieving micron tolerances requires control, and you can only really control what you undertake yourself. In addition, it allows, for example, the tooling manager or production manager to be engaged early in the product development cycle, helping to avoid having to go back to the drawing board with designs, having to review and change manufacturing processes, and having to recut already extremely expensive and time-consuming to make micro tools. IS IT TRUE TO SAY THAT OF ALL THE ELEMENTS OF THE PRODUCT DEVELOPMENT PROCESS, MICRO TOOL FABRICATION IS PERHAPS THE MOST CRITICAL FOR MICRO MOLDING? The simple answer here is yes, and yes again! Without a good micro tool, you will not be able to make millions of end-use products repeatably and with the micron features required. Also, a poorly fabricated micro tool could eat up all your tolerance slack for the design to manufacture process in one hit. So, it is important that at the tooling end, the technology for fabrication is used that means you are well within the overall tolerance levels, so that there is some margin as the product development process progresses. Micro molders need to have at their fingertips an array of technologies that enhance the accuracy of a micro tool, often needing to employ wire EDM and extremely accurate milling machines. But optimizing the tool begins before fabrication, and success is achieved by an experienced micro molder ensuring that tool design and fabrication engineers work together to ensure successful outcomes where the watch words are “ultra-precision” and “right first time.”

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COVER STORY

AFTER TOOLING THERE OBVIOUSLY COMES THE MICRO MOLDING PROCESS. I SUPPOSE IT IS FAIR TO SAY THAT THIS IS NOT JUST NORMAL MOLDING BUT SMALLER? Yes, you could say that. Many people say that molding on the macro level is a science, and molding on the micro level is an “art” and a science. This is absolutely true, and again plays to the fact that success can only be achieved when a micro molder has the experience and aptitude to think out of the box and be creative in any given micro molding scenario. When micro molding, and when being constantly pushed to manufacture tinier and tinier parts with more and more exacting features, the “art” comes from knowing where and when you can push the limits of micro molding. This is where years of experience is critical, rather than just relying on numbers on a data sheet or flow analysis. These variables are numerous, but include such things as residence time, injection pressure, mold temperature, etc. An experienced micro molder will manually dial in such variables to optimize the molding process for the specific material and geometric complexity of any given application, and by so doing will be able to keep a lid on tolerance slippage. Quite obviously, once again, this part of the process also exemplifies the key role of micro tooling in the tolerance attainment equation. Whatever adjustments and fine tuning a micro molder will make to optimize outcomes from the micro molding process per se, ultimately the end result is that high pressure molten plastic will be injected into a tiny cavity, often containing extremely fragile core pins that can obviously deflect or break. The tooling must be able to stand up to this, or all the expertise from the micro molder will be lost. WE ARE USED TO THE PHRASE, ‘IF YOU CANNOT MEASURE IT YOU CANNOT MAKE IT’. HOW IMPORTANT IS VALIDATION AND METROLOGY IN RISK MITIGATION? Metrology has a key role to play in any micro molding product development process, and it is vital to use measuring technologies that are able to validate end-use products with feature sizes that are always extremely tiny. Without being able to do so, it is impossible to show that a product conforms to design intent and is therefore fit for purpose. So, saying, micro molders need to be equipped with state-of-the-art metrology tools and adhere to strict measurement protocols.

Success requires that a micro molder is vastly experienced and vertically integrated. With any measuring tool, there will always be an inherent variation in the measurement system used. In a micro molding scenario, it is hugely important to establish confidence in the accuracy and reliability of the chosen measurement system(s). While other sources of measurement variation exist, the two key sources are equipment variation (repeatability) and appraiser variation (reproducibility). Reducing Repeatability and Reproducibility (R&R) variation to the lowest amount possible, gives us confidence in detecting variation in the product being manufactured. Evaluation of the measurement system in terms of gage R&R should be an important element of any continuous improvement activity, especially with micro molding applications where any variation in the repeatability and reproducibility of the measurement could crucially eat into the low margins for error in terms of tolerance attainment. YOU HAVE TOUCHED UPON THE KEY AREAS WHERE CONTROL OF TOLERANCES IS FUNDAMENTAL. WHAT ELSE DO YOU NEED TO KEEP AN EYE ON? There are numerous other factors that require attention such as material variations that can lead to differential results when molded, and environmental issues such as humidity and temperature that can alter the dimensional characteristics of end-use parts. All considerations, however, lead to the same conclusion - success requires that a micro molder is vastly experienced and vertically integrated.

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3D PRINTING AND PROTOTYPING

A new direction BLAKE TEIPEL, CEO AND CO-FOUNDER OF ESSENTIUM, DESCRIBES HOW 3D PRINTING IS TRANSFORMING THE ORTHOTICS AND PROSTHETICS (O&P) INDUSTRY. WHAT ARE THE BIGGEST CHALLENGES FACING O&P PRACTITIONERS TODAY? One of the biggest challenges for practitioners is meeting the needs of patients in a timely and efficient manner. The World Health Organization estimates there are about 30 million people worldwide who need prosthetic limbs or other mobility devices, yet fewer than 20 percent of these people have access to them. HOW CAN 3D PRINTING CHANGE THE GAME FOR O&P PRACTITIONERS? 3D printing enables practitioners to rapidly develop O&P devices that are costeffective and fully customized to the wearer. 3D printing allows for the bespoke process of O&P design to be expedited as practitioners can still make each device unique, but they don’t have to go through as many steps and spend as much time as they do now. With 3D printing, a prosthetic that once took many hours to make can now be completed in a fraction of that time. In fact, practitioners can see an increase in efficiency as high as 400 percent with 3D printing, and that means they can dramatically increase the number of patients they treat in a given year. In addition, material advancements are enabling O&P practitioners to create O&P devices that are more customized, lightweight, affordable and comfortable for the patient. For example, Ultramid polyamide reinforced with short carbon fiber, enables lightweight, yet tough and more flexible prosthetic sockets. The definitive socket can be made with thermoplastic material that enables small adjustments in increments of 2-3mm without weakening as needed throughout the life cycle of the prosthetic - a crucial development as a patient’s body changes over time. HOW DO O&P PRACTITIONERS NEED TO PREPARE FOR THE TRANSITION TO 3D PRINTING? As O&P practitioners begin to embrace 3D printing, they will need a proven approach for 3D printing implementation, training and support. They will also need to develop skills that allow them to stay relevant but also to utilize the medium successfully. This includes material knowledge and design for 3D printing.

3D printing takes advantage of a wide range of materials with different properties. To unlock the potential of their creativity, practitioners will need to stay up to date with new materials and their properties to decide which material can provide the solutions they are looking for. WHAT ARE THE BENEFITS OF 3D PRINTING FOR O&P PATIENTS? With an increasing number of global amputees each year, the need to make prosthetics more accessible and capable is also increasing. Advancements in 3D printing technology is making this possible, even in parts of the world where there are no trained prosthetists. In addition, patients today want access to ever more functional prosthetics, ranging from dynamic legs with shock absorption and carbon-fiber blades (or feet) to bionic arms with nimble fingers. With today’s innovative 3D printing platforms, all of that is possible. In fact, there are almost no limits to where prosthetics can go with 3D printing. HOW IS 3D PRINTING TECHNOLOGY HELPING TO REDEFINE PHYSICAL DISABILITY? With the advent of 3D printing, the possibilities offered by advanced 3D printing technology for O&P could force a change in public attitudes and eventually blur the line between disability and ability through greater functionality. At the very least, 3D printing will enable the creation of O&P devices that would simply be impossible to make by hand or by traditional manufacturing processes.

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MD&M WEST

WHAT'S TRENDING? OUR EDITOR LAURA HUGHES DISCUSSES WHAT EVERYONE WAS TALKING ABOUT AT MD&M WEST EARLIER THIS YEAR.

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D&M West claims to be the largest medical design and manufacturing event in the world, and this year the event celebrated its 35th year. After visiting the United States in 2019, I had heard from several companies how important a show MD&M West was for them, and an event they eagerly looked forward to. So, I wasn’t surprised when I arrived on the first day of the show, to see the picturesque venue in the LA sunshine surrounded by thousands of attendees. With the exhibition floor, talks and workshops constantly providing a range of topical offerings, I had to force myself outside to get some quick fresh food from the food trucks at lunch time.

During MD&M West, I was able to attend a panel discussion on sustainable packaging. Here, it was highlighted how many factors there are to consider when aiming for sustainable packaging. These include but are not limited to: • How much water was used to create this packaging? •H ow many greenhouse gases and toxic chemicals were involved in the process? • Can this material be repurposed? • What parts can be recycled and where? However, a manufacturer’s number one priority will probably always be to ensure the medical device fulfils its purpose and meets the required regulatory standards, before looking to ensure it is sustainable.

There was, however, two key subjects I noticed during talks, workshops, panel discussions, and meetings which were constantly being mentioned. These were sustainability and EU MDR. SUSTAINABILITY Excessive and non-recyclable packaging is something that has recently been scrutinized in the media, with big supermarket chains taking action such as the removal of packaging around multipacks. The medical sector is no different, with manufacturers and consumers both taking an interest in the material within medical devices.

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MD&M WEST

It is also important to bear in mind how sustainability means different things for different people. For some people it is using less material, whereas for others it is using material that can be recycled. Steve Duckworth, global head of segment medical and pharmaceutical, Clariant, said for him, “it is more about using less material, rather than making everything recyclable.” He explained how the company’s number one priority is to ensure that the device does not compromise patient safety. Duckworth also highlighted how once medical devices are recycled, these devices cannot then be re-used in the medical field. He explained there can be issues around the responsibility of these devices following recycling, if a single use medical device is recycled and reused and an incident occurs. Additionally, awareness is also a really important factor to think about. Education is needed so that both users of medical devices and the manufacturers know which parts can be recycled and where. For instance, everyone knows aluminium can be recycled, but more information is often needed as to which plastics can be recycled and where. Solvay, a materials and chemicals company, explained how there was a real focus currently on replacing single use metal with plastic. However, I was informed that the plastic currently used is not recyclable. Rose Catherin, sales development manager, Solvay, explained this is because of a supply chain issue. Catherin said how there was not a system in place to collect the devices from the hospital and take them to a relevant location in order for recycling to take place. It is clear to me more actions are needed both by consumers and manufacturers to ensure we are acting in an optimal way for our environment. Although, I do think we have come a long way, and by talking about the topic at big industry events we are only going to make advancements more rapidly. EU MDR The European Medical Device Regulation (EU MDR) was planned to take effect on 26th May 2020. However, following the coronavirus pandemic, the European Commission has stated this deadline will be delayed. This regulation applies to all manufacturers selling medical devices within Europe and aims to provide greater protection of public health and safety. The subject is a real hot topic amongst the manufacturers of medical devices. During MD&M West there was multiple talks on the subject, and it was brought up in my meetings with various organizations. Additionally, our latest North American magazine which was distributed at the show featured a two page article on EU MDR and a survey we had conducted with our readers. This was regularly highlighted during our meetings as an article that organizations had found particularly interesting. How ready are companies for the implementation of EU MDR? Well, if the audience of the EU MDR talk I attended during the show are anything to go by - not very. Isabelle Lang-Zwosta, a global regulatory affairs and business development director – medical (MD) from Knoell Germany, delivered a talk on how to overcome the hurdles of MDR and provided manufacturers with a last minute checklist during the show. At the start of her talk she asked

people in the audience to raise their hands if they were ready for EU MDR, and not a single person raised their hand. Lang-Zwosta highlighted how if you had begun preparations in 2017, you would be prepared, however, this is not the case for many companies. Companies who are attempting to prepare for EU MDR are facing multiple barriers as part of the process, such as the need to recruit someone who is responsible for the process within each organization, the Eudamed database failing to be up-to-date, and queues of 6,000 for notified bodies! An important point Lang-Zwosta raised was that organizations really need to look at the sales around their medical devices. This is because it is expensive to get a device to comply with EU MDR, and so companies need to be sure the process is worth it before beginning. Despite the postponement, the EU MDR deadline is still rapidly approaching, and companies will need to work hard to ensure they are as prepared as they can be for the deadline. However, with an out-of-date Eudamed database, a huge queue for notified bodies and the disruption caused by the coronavirus pandemic, I think multiple companies will struggle to comply with the deadline.

By talking about the topics at big industry events, we are only going to make advancements more rapidly.

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The perfect balance WHEN CAN YOU STRETCH OR ADAPT EXTRUSION CAPACITY AND WHEN SHOULD YOU RETOOL? ERNIE PREIATO, VICE PRESIDENT OF EXTRUSION, AND DAVE CZARNIK, R&D/LAB MANAGER OF EXTRUSION, BOTH FROM CONAIR EXPLAINS.

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ost medical tube extrusion lines begin with very basic concerns: How do I process this material into tubing with enough speed and efficiency to make a good product and a good return? Concerns get translated into requirements, and ultimately into an extrusion system. Sometimes, processors develop and purchase an entire line at once - perfectly matched to current production requirements. Yet at other times, processors may also wonder if they can successfully want to react to business and competitive needs by adapting existing extrusion equipment and tooling. However, there are risks and difficulties in adapting, and results may produce problems rather than cost savings. Below

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we explain a number of situations that we have found are common in the experience of tube extruders, and suggestions for resolving them with a minimum of difficulty. To see what can go wrong when you attempt to adapt a line to new requirements, it’s important to understand what needs to be right for that line to work properly. Ideally, any new extrusion line is designed to process a specific material at a specific speed, through a specific die at a specific temperature, and calibrate it to a controlled size through properly designed tooling with an adequate cooling process. Everything is in balance: • Extruder is appropriate for material mix, production rate. • Die dimensions are suited to material characteristics and product size. • Drawdown rate is calculated, so predicted size of extrudate cone matches inlet of sizing tooling. • Proper sizing method selected, calibration tooling prepared, with cooling adequate to product requirements. • Production runs smoothly at a selected line speed, and line is stable. When a few “real world” challenges arise, we discuss whether it is possible for processors to adapt using the equipment they have, or whether they must retool to deal with the change.


TUBING, CATHETERS AND STENTS

Finished multi-lumen medical tubing

1 CHANGE IN TUBING DIMENSIONS Frequently, processors of the specialty pipe or tube need to make small dimensional changes or produce a slightly different size using the same material. For example, a tubing maker who makes 3/8 inch tubing (0.3750 inch diameter), might get an order for 1/4 inch tubing (0.25 inch diameter). Rather than invest right away in a new die, the processor decides to see if the existing 0.3750 die can do the job with the help of new calibration tooling. In some cases, it is possible to use a die designed for a larger diameter product to produce a smaller diameter product, but the ability to do so depends on the material - materials that exhibit a high degree of drawdown are very forgiving of size reductions. For example, many medical tube makers are familiar with Pebax (polyether block amide), a highly viscous material with a high level of drawdown. A small, thin wall tube (0.125in OD x 0.008in wall) will use a drawdown of 50% or more since the material is more viscous and pulls down quickly as it leaves the hot die. So, it is certainly possible to use a 0.375 in die to produce a ¼ in tube product using that material. One case where it would not be possible involves a material like rigid PolyVinyl Chloride (PVC). The drawdown rate of that material is so low that you may not be able to achieve the needed size reduction, so you would need a new die and new tooling. Increase production rate and/or speed When a line is working well, you might wonder: Can it continue to produce but at a higher rate? The answer is that it depends. Line speed increases of up to 20% may be possible if you incrementally increase both puller and extruder speed - and if you’re running materials that will tolerate the change e.g. polyethylene, polypropylene or other polyolefins.

because the “identical material” has a wider molecular weight distribution - it tends to swell upon exiting the die, causing periodic overpacking of the calibration tool and tube wall inconsistencies whenever the excess extrudate “folds in” and goes through. Finally, after numerous adjustments and plenty of scrap, the drawdown problem is corrected, and the line is stabilized. The lesson here is pretty simple and has nothing to do with equipment: To extrude with consistency, you have to buy materials with consistency. Develop a window of tolerance for the molecular weight distribution of materials you buy and stick to it. CONCLUSION To many processors, tube extrusion still looks and feels a lot like an art, since there seem to be so many judgments to be made, so many factors - large and small - to “get right” before a process will work properly. Yet, if you organize and leverage design, materials, and production experience, you may find it possible not only to master this process for the medical tube products you’re currently making, but to cost-effectively stretch the capabilities of your equipment and processes to achieve even greater flexibility, productivity, and output. Sometimes you’ll need new equipment, new dies or tooling, or improved controls to get the job done - but not always. In our experience, many processors are surprised at just how adaptable the extrusion process can be.

If you elect to boost line speed and extruder output, you are raising the risk of process instability. Higher extruder revolutions per minute will tend to increase material shear in essentially the same way as if you raised the temperature profile of the material. Boosting line speed may also require you to adjust the amount of material going into the extruded pipe or tube or adapt the “adjusted size” of the contact tooling, since higher line speeds are associated with greater shrinkage of the end product.

Downstream view of a typical medical extrusion line for production of small diameter tubing. At the end of the line is an automatic coiling system. Conair ©

2 CHANGE IN MATERIAL SUPPLY Within “identical” types and grades of material, small variances in key characteristics can be sufficient to upset extrusion processes and require time-consuming adjustments. For example, a processor who is making nylon tubing for a new customer might select a better grade of material, and, based on their experience with that material, the processor’s extrusion team sources tooling and “dials in” the line to perfection. Later, to take advantage of a great price, the processor sources “identical” material from a different supplier, however, extrusion efficiency suffers WWW.MEDICALPLASTICSNEWS.COM

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THE LEADING VOICE IN POLYMER INNOVATION FOR THE MEDICAL DEVICE SECTOR Medical Plastics News provides essential information on materials and engineering processes for anyone involved in the design, supply and manufacture of plastic medical devices.

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PEEK AND HIGH PERFORMANCE POLYMERS

UNDER PRESSURE CHERYL WECKLE, TECHNICAL SERVICE AND DEVELOPMENT, TRINSEO, DISCUSSES HOW CHEMICAL RESISTANT GRADES PREVENT DAMAGE TO PLASTICS IN THE FIGHT AGAINST HEALTHCARE ASSOCIATED INFECTIONS (HAI).

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AI continue to be a concern in medical environments due to more resistant strains of viral, bacterial, and fungal pathogens emerging all the time. To address this challenge, the World Health Organization, Centers for Disease Control, and other regulatory bodies have prescribed certain steps that can be taken to minimize the risk of infection spread. An important step pertains to cleaning and disinfection of medical equipment surfaces. Plastics are frequently used for medical equipment housings as a material of choice as a metal replacement for a variety of reasons. These include the potential for cost savings and light weighting, design freedom, parts consolidation, and cosmetic appeal. The challenge with plastic, which brings so many advantages, is its propensity to fail because of rigorous disinfecting procedures combined with increasing aggressiveness of chemicals. Premature cracking and failure of a plastic part due to the action of stress and contact with a chemical agent is known as Environmental Stress Cracking (ESC). This mechanism can be described as follows: 1. Solvent migrates into the polymer surface of a stressed part. The plastic surface is softened or plasticized. 2. Small surface defects are formed and stress concentrates around the tip of the crack. Solvent absorption increases in this region. 3. Stress is relieved as polymer chains pull apart from one another. The defect widens and eventually leads to cracking and complete failure. Research and usability studies show that ESC failures are caused by a combination of multiple factors. First is the plastic material itself, which can have more or less resistance to solvents depending on the base polymer structure and the product recipe including additives. The second factor is the stress on the part, which can be due to molding, design, assembly, or even environmental factors. Lastly is the nature of the disinfectant, solvent, or chemical and how frequently it is applied.

The material selection process should include testing against the disinfectants that would be commonly used in the life of the equipment. For plastic materials it is recommended to perform testing according to ASTM D543-14, where specimens are placed under stress and exposed to chemicals for specified time periods. Following exposure, the samples can be tested for retention of physical properties and data can be analyzed and interpreted with strict attention to detail. Often the start of failure can be seen when looking under a microscope as tiny stress cracks in the part surface. In other cases, complete brittle failure is immediately evident. While these tests can allow relative comparisons of the performance of materials and disinfectants, it is important that final assessment be done on fully assembled devices and equipment. This is the only way to evaluate and incorporate all aspects of an application’s design which can potentially contribute to its overall durability and life.

From a material design perspective, all these factors need to be balanced against performance property requirements and regulatory compliance concerns. The application itself and environment in which it functions must be evaluated along with different resin types, cleaning options, and protocols. This will result in the most effective material selection that can withstand chemical antagonists necessitated in today’s healthcare environment.

Often the start of failure can be seen when looking under a microscope as tiny stress cracks in the part surface.

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PATENTS AND TRADE SECRETS

Are you protected? WEB CONTENT EDITOR IAN BOLLAND SPOKE TO PHILIP NELSON AND TOM COWAN FROM KNOBBE MARTENS, TO DISCUSS TRADE SECRETS AND PATENTS IN THE UNITED STATES, TRENDS BEHIND ITS USAGE, AND WHAT MIGHT BE BETTER FOR MEDICAL DEVICE COMPANIES TO ADOPT.

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s medical device companies move towards using software in devices, particularly in the cases of smart devices, the US Supreme Court case of Alice Corp versus CLS Bank International becomes more relevant to the industry. The case highlighted whether software patents were patentable. It heard the argument that software is too much of an abstract idea, with debate over whether an inventive concept is involved or not. As a result, the US Patent Office seemed more reticent since the 2014 court case to grant software patents after it received some bad press for issuing patents that were viewed as too broad by some. This has included an MRI machine that was declared as patent ineligible back in 2017, as the ruling stated: “It can accurately be characterized as being directed to an abstract idea and not eligible as patentable subject matter.” Explaining the effect of the Alice versus CLS Bank on the medical device industry, Nelson said: “There’s a lot of medical device patents that involve smart devices these days that incorporate an algorithm or software somehow and, for a while, medical device patents still flowed at generally the same rate. “Over the last couple of years, the patent examiners that were deciding whether to allow medical device cases started to look for these software aspects. On many occasions the fact a device has this software aspect would be the thing

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that distinguishes it over the prior art because these were being connected to the internet of things or to the hospital information system somehow. “The novel aspect was often software, but the US Patent Office were treating it as if some software aspect would be like a poison pill for the patent application process, and they would say it’s too abstract - even though there were other aspects of the claims that were mechanical and not software related at all. “It wasn’t across the board, but I was noticing that more in the last few years. The pendulum might be swinging back the other way because the current director of the US Patent Office (Andrei Iancu) is trying to teach the examiners not to let that sort of analysis affect their thinking.” Following an uptick in rejections, Nelson believes they are starting to fall slowly. Cowan explains how medical diagnostics have been under the same kind of scrutiny for the law of nature issue – one of the excluded areas for patent eligibility. “We saw in the last five or ten years, medical diagnostic tools like lateral flow assays, testing for enzymes or certain antibodies in the body or in bodily fluids come under scrutiny because of the expanded doctrine of ineligibility that pertains to laws of nature. “Medical diagnostic devices can sometimes be thought of as medical devices – that for me I’d say is the other big problem area, but if it’s more mechanical and less emphasizing the software aspect you’re pretty safe.” When it comes to protecting devices, Nelson feels it is important for companies to consider whether they want to use the patent system at all. “In general, we advise clients that come in with intellectual property to take a hard look at what the best avenue for protection is. Trade secrets is an option for protection but the way you protect a trade secret is just by keeping it secret and providing company policies and agreements that make sure your formulas are locked away. “If it’s the sort of thing that’s in a fast-moving field where there’s lots of innovation going on, and you’re going to be passed by in a few years anyway, maybe the patent system is useful. “If it’s going to be something that’s really hard to reverse engineer, like a chemical formula, or a really detailed, underlying algorithm, you might want to keep it as a trade secret. “If it’s easy to reverse engineer the only option is to keep it under a trade secret and protect it with confidentiality agreements and so forth. If it’s harder to reverse engineer, it is wiser to keep it a trade secret, but you still have the option.”

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PATENTS AND TRADE SECRETS

Both Nelson and Cowan suggest there is more public awareness of the patent process, partly because of their desire to read up on the issue, and non-profit organizations who are anti-patent who often talk about patent trolls. Cowan explained there was a feeling that unscrupulous entities were taking advantage of the system in that they weren’t making any products but were buying patents to sue people and recover money in damages. “There has been a successful PR campaign, a narrative that somehow there’s more litigation now. Actually, the litigation rate, if you look at the number of patents, is at the same or lower level than it’s been. “Just because society is technological, and technology is so ubiquitous now, everybody is pretty much using some kind of technology. The public is more acutely aware of it.”

When it comes to protecting devices, Nelson feels it is important for companies to consider whether they want to use the patent system at all.

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COMPONENTS & ASSEMBLY

MICHAEL GOEHRING, INDUSTRY MANAGER FOR MEDICAL AND PHARMACEUTICALS, ZWICKROELL IN NORTH AMERICA, EXPLAINS HOW LEAN MANUFACTURING METHODS SPUR INNOVATIONS IN THE TESTING OF DRUG DELIVERY DEVICES.

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FORWARD THINKING

he number of people who live with diabetes is on the rise. The World Health Organization (WHO) estimates that one in eleven people are affected by the disease. This makes the auto-injector market one of the fastest growing subsets of the pharmaceutical industry, with a predicted market volume of over $2.5 billion by 2020. Moreover, with the rise of biologic and sustained release drugs, the market will see an even greater demand for auto-injectors in the near future. Strict regulations by the Food and Drug Administration (FDA) for these class II devices mean that testing to ISO 11608-5 is a critical step for manufacturers in guaranteeing the quality and safety of its products. Whether testing is managed in-house or handled by a contract testing laboratory, for one or for many different product designs, these companies are turning to testing platforms that are both versatile and comprehensive. Testing must support manufacturing protocols and industry regulations, while maintaining absolute accuracy and reducing time to market. As a result, concepts used in modern manufacturing have shaped product development.

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Best practices from lean manufacturing and other methods rooted in quality management systems are often part of the design process. Features based on poka-yoke principles help auto-injector producers manage high volumes and maintain compliance with Good Manufacturing Practice (GMP) standards and FDA regulations at the same time - reducing the potential for costly errors. Poka-yoke systems, first established in Japan by car manufacturer Toyota, prevent inadvertent errors made by workers performing a process. Companies have benefited by implementing such systems because they are able to eliminate set-up errors and decrease set-up times to boost production throughput, improve quality, increase safety, and lower costs. Implementing this type of “mistake proofing�, as it is sometimes called, has never been more crucial in the pharmaceutical and medical device industries, as companies strive to ensure compliance with regulatory requirements while providing next-generation products on which patients can rely. In a high throughput testing environment where, for example, auto-injectors are manufactured, multiple operators use the testing system over the course of a production period. The gathered results are then evaluated to make decisions on product quality. Reducing the steps required to set up and run tests improves efficiency and substantially minimizes the potential for inadvertent human error. A typical market solution is a semiautomated testing machine that requires an operator to load the test specimen, close the safety door, and start the test. From that point forward, all steps in the test sequence are carried out automatically by the machine within just a few minutes per injector. To reduce the risk of operator errors even

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COMPONENTS & ASSEMBLY

Testing to ISO 11608-5 is a critical step for manufacturers in guaranteeing the quality and safety of its products. further, a robot-driven fully automated testing system removes the autoinjector from the cartridge and inserts it into the testing machine. Typical tests performed by semi or fully automated solutions measure the cap removal, activation force, delivered volume, injection time and needle shield blocking force in one continuous process. Software directs the robot to remove insulin pens one by one from the magazine, feed them into the testing machine, and start the test. The test process is significantly more efficient because of increased specimen throughput. Test result accuracy also increases because operator influence is minimized. Another way to reduce operator influence is through the use of barcodes as early as the test setup phase. A barcode and Bluetooth integration feature like the one introduced by ZwickRoell ensures consistent selection of jaw faces and grips when running tests, because every auto-injector type has a slightly different design and requires a unique test setup. First, the correct jaw face and grips are selected, and their configuration is saved in the software, so it is impossible to start a test with the wrong accessories. Then, a Bluetooth transmitter in the auto-injector testing system works together with a special barcode reader to help the operator simplify test setup. Before the operator starts the test, the testing software specifies the exact tooling needed for that particular test and auto-injector. The operator pulls the corresponding grips and uses the barcode to scan the jaw face. The software then validates the selection of the correct configuration, allowing the test to continue. If the operator chooses the wrong grip, the software does not allow the test to start and prompts the operator to choose the grip that corresponds to the type of auto-injector being tested. Grips and

jaw faces are also color-coded to visually aid in selection of the right tooling. Furthermore, medical device product development is subject to many regulations that require test- and system-relevant actions and settings to be logged. Regulation 21 CFR Part 11 on electronic records and electronic signatures of the United States FDA defines acceptance criteria for the use of electronic records and electronic signatures in place of records in paper form and handwritten signatures on paper. These electronic documents must be handled with as much confidentiality, be just as authoritative, and hold the same value as the paper documents. Testing software that makes it possible to create documentation for the testing process that is complete and tamper proof is vital for companies subjected to the regulated areas of the medical and pharmaceutical industry. Growth in market demand for auto-injectors is placing greater emphasis on throughput. Yet accurate test results are critical when it comes to patients’ health. This challenge has motivated manufacturers to seek solutions that streamline and automate the testing process without sacrificing accuracy, repeatability, reproducibility and traceability. Implementation of mistakeproofing mechanisms ensures consistency in testing programs, further elevating accuracy in measurement and supporting excellence in manufacturing that complies with GMP standards and FDA regulations.

ZwickRoell Š

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WHO launches digital app to improve care for the elderly

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he World Health Organization (WHO) has launched a digital healthcare technology tool which aims to help health and social workers improve care for the elderly. The interactive digital application is called, ‘WHO ICOPE Handbook App’ and

provides practical guidance for conditions such as mobility limitations, malnutrition, vision and hearing loss, cognitive decline, depressive symptoms and social care and support. This digital application is needed because the world’s population is aging at a fast

3D PRINTING IN SPACE

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uman heart cells have reportedly been 3D printed on the International Space Station (ISS) and are making their way back to Earth this week inside a SpaceX capsule. The 3D BioFabrication Facility (BFF) was developed by an operator of microgravity research and manufacturing equipment, Techshot, in partnership with nScrypt, a manufacturer of industrial 3D bioprinters and electronics printers. When soft, easily flowing biomaterials are printed on Earth the tissues collapse under their own weight. However, when

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pace, and by 2050 one in five people will be over 60. Although every person is different, both physical and mental capacity typically decline with increasing age. The app hopes to enable health and social workers to better address the diverse needs of older people.

Bioplastics: Where are we now?

printed in space, the 3D-printed structures maintain their shapes due to gravity.

bioplastics produced globally are biodegradable, they are renewably sourced.

“Our BFF has the potential to transform human healthcare in ways not previously possible,” said Techshot president and CEO John Vellinger. ”We’re laying the foundation for an entire industry in space.”

Bioplastics are not without their own issues and are often significantly more expensive than plastics – an additional cost consumers and businesses aren’t usually willing to pay for.

3D bioprinting was planned to take place in March when additional bioinks were delivered to the ISS National Laboratory aboard SpaceX mission CRS-20. It is important to note that the 3D printing of other organs in space remains at least a decade away.

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recent report by market research company IDTechEx titled, “Bioplastics 20202025”, forecasts global plastics production to pass 600 million tonnes by 2030. However, there are often issues around the recycling of plastics. Therefore, a potential solution to world’s plastic problem is the growing bioplastics industry. Although only around half of the

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Companies are working hard to try and produce cheap biobased polymers at scale. A start-up in California, Newlight Technologies, claims that its AirCarbon brand bioplastic, produced by ocean bacteria from waste gases from the dairy industry, is cheaper to produce than conventional plastics. IDTechEx’s report reviews a range of available bioplastics, as well as evaluating the benefits and challenges with production.


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To find out more contact Sarah Livingston tel: +44 (0) 1244 952 358 sarah.livingston@rapidnews.com @MPN_Magazine Medical Plastics News



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