MEDICAL PLASTICS news
Decision Time +
Schott explains when polymer is the best choice for syringes
WHAT MEDTECH IS PREDICTING FOR 2017 ACCUMOLD’S MISSION TO MAKE THE WORLD A SMALLER PLACE COATINGS
ISSUE 34
Jan-Feb 2017
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C d n a t S t a s u t i Vis
CONTENTS Jan-Feb 2017, Issue 34
Regulars
Features
5 Comment Lu Rahman’s global view
19 Opinion Rachel Nagy, Owen Mumford explains the benefits of a combined approach to manufacturing
7 News analysis What’s the difference between an app and a medical device? 8 Digital spy 11 News focus ISO 13485 – are you ready? 13 News focus What Chinaplas 2017 has to offer 16 Cover story Schott explains the benefits of polymer syringes 42 02:2017 The medtech info you really need to know
20 The world in motion After the political excitement of 2016, sectors across the world are viewing 2017 with interest and the medtech sector is no exception, says Lu Rahman 23 Playing by the rules Ineos and Eastman outline the latest expertise in materials 27 Keep it clean MasterControl looks cleanroom quality and planning in the manufacture of medical devices
29 Material gains Raumedic and silicone’s role in medication pumps 30 Making the world a smaller place Accumold’s thoughts on micro moulding, medical manufacturing and the future of the industry 32 Smooth operators Compound Solutions and Whitford reveal the latest coatings for medical devices 38 Meet the polymer superheroes says Lucideon 41 Taking control Tegra Medical explains how the installation of robots has doubled production
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CREDITS
EDITOR’S
group editor | lu rahman
comment
deputy group editor | dave gray reporter | reece armstrong advertising | gaurav avasthi art | sam hamlyn publisher | duncan wood Medical Plastics News is available on free subscription to readers qualifying under the publisher’s terms of control. Those outside the criteria may subscribe at the following annual rates: UK and Europe: FREE North America: £249 Rest of the world: £249
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World vision
s many of you know, the start of 2017 saw the launch of MPN North America, making our medical plastics community increasingly global.
subscription enquiries to subscriptions@rapidnews.com
With that in mind the political situation in the US – and how it could affect the global medical device sector – is highly interesting.
Medical Plastics News is published by: Rapid Life Sciences Ltd, Carlton House, Sandpiper Way, Chester Business Park, Chester, CH4 9QE
The potential repealing of the medical device tax has been viewed as a positive step for many companies working in the industry. The Advanced Medical Technology Association (AdvaMed), has never been a big fan of the tax, which was created as a funding measure for Obama’s Affordable Care Act. The association believes it harms job creation, deters medical innovation and increases the cost of healthcare.
T: +44(0)1244 680222 F: +44(0)1244 671074 © 2017 Rapid Life Sciences Ltd While every attempt has been made to ensure that the information contained within this publication is accurate the publisher accepts no liability for information published in error, or for views expressed. All rights for Medical Plastics News are reserved. Reproduction in whole or in part without prior written permission from the publisher is strictly prohibited.
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It will be interesting to see what happens. The country has already received what many perceive to be a step in the right direction with the 21st Century Cures Act. AdvaMed is again a supporter of this which many hope will lead to faster approval for medical devices. Of course it’s not just the US that the global medical device sector is eyeing with interest. China is still regarded as holding opportunities for medtech. As it continues with its ‘Made in China 2015’ and its localisation policy, medical device companies from outside the country have been urged to find local partners before trying to do business helping them overcome any challenges.
Guidelines for the Preparation of Special Reports on the Application of Innovative Medical Devices to encourage medical device innovation and promote the practice of new medical device technology. The publication aims to help China’s medical device localisation process, and to boost the development of the Chinese medical device industry. Closer to home and as 2017 progresses no doubt many medical plastics firms will be keen to keep a close watch on whether Brexit has a marked effect on the medtech sector. While stock markets plummeted once the result of the referendum was announced, it seems the UK economy is currently coping well with the result. Back in August, manufacturing output was reported to have rebounded to a ten month high but only time will tell as to how this will pan out over coming months.
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No doubt many medical plastics firms will be keen to keep a close watch on whether Brexit has a marked effect on the medtech sector.
On a global scale the medical device sector offers wide-reaching opportunities despite on-going political and economic change. With markets such as China, India and Kenya holding revenue opportunities, there is much to be positive about as well as take advantage of as the year unfolds.
The CDFA (China Food and Drug Administration) recently published WWW.MEDICALPLASTICSNEWS.COM
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NEWS ANALYSIS
Can you tell the difference between an app and a medical device?
H
ealth apps have surged in popularity recently and are now used daily on smartphones and tablets worldwide. In certain circumstances, Maliha Carey, from health apps may be legal firm, Stevens classified as medical & Bolton asks when devices and are therefore is an app a medical subject to a number of different regulatory device and why does r e q u i r e m e n t s . T h e it matter? Medical and Healthcare products Regulatory Agency (MHRA) has recently published updated guidance, intended to assist app developers and manufacturers of medical devices in assessing whether their product is a medical device, and ultimately help ensure compliance.
Apps may be classified as medical devices if they:
Why does it matter if your app is a medical device?
l aim to diagnose skin cancer from an
If an app falls to be classified as a medical device it will be regulated by the MHRA and must comply with certain requirements before it can be placed on the market. The manufacturer will also have certain responsibilities once the app has been placed on the market, for example in monitoring and reporting adverse incidents. In the UK, failure to comply with the relevant legislation relating to medical devices may result in a fine and/or imprisonment, as well as negative publicity and censure from the regulator.
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Apps are unlikely to amount to medical devices if they: l r ecord images of skin conditions
Is your app a medical device? An app will be classified as a medical device if it has as its intended purposes one or more of the “medical purpose(s)” set out in the legislation: l prevention of disease; l diagnosis of disease,injury or handicap; l m onitoring of disease, injury or handicap; l t reatment or alleviation of disease, injury or handicap; l compensation for injury or handicap; l i nvestigation, replacement or modification of the anatomy or of a physiological process; l c ontrol of conception The updated guidance clarifies that the app must be linked to a specific disease, injury or handicap in order to fall within one of the medical purposes. This means that some of the more generic wellbeing and health monitoring apps are less likely to fall to be regulated as medical devices. The guidance seeks to provide clarification by setting out examples, including the following:
image taken by the app; a re designed to indicate the risk of a user developing a particular disease based on the information provided; monitor and collect patient information and the output is intended to affect the treatment of the patient; a re designed to calculate the dose of insulin a diabetic needs to treat their diabetes based on carbohydrate in a meal; m ake recommendations to seek further advice based on the information provided by a user.
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which are then reviewed by a medical professional; a re designed to indicate the risk of a specific group of the population developing a particular disease; m onitor general health or fitness information (e.g. heart rate) or are intended to treat non-medical conditions (eg. non-specific stress); p rovide tips or advice on how to prevent a particular disease or make general recommendations to seek further advice; a re designed to remind users to take their medication.
The medical purpose intended by the manufacturer or developer is relevant in assessing whether an app amounts to a medical device. App developers should therefore carefully review the description of what the app is intended to be used for in any promotional materials, labelling and instructions. It is important to note however that a general disclaimer will not be sufficient if the app does in fact qualify as a medical device. WWW.MEDICALPLASTICSNEWS.COM
Changes on the horizon Certain changes are on the horizon which may impact the regulatory regime relevant to medical devices. Firstly, the current legislation relating to medical devices is being revised. The new EU Medical Devices Regulation and EU In Vitro Diagnostics Regulation, replacing the current EU directives, are expected to be adopted this year and come into force over the following three to five year period. Secondly, the UK voted in June to leave the EU. However, EU legislation continues to apply to the UK until the UK actually leaves, and therefore there is no impact on medical devices regulation in the short term. The longer term impact will become clearer once the terms of the UK’s post-exit relationship with the EU are known. In the event of a ‘soft Brexit’ businesses in the UK are likely to be required to comply with the majority of EU legislation. If there is a ‘hard Brexit’ the UK may adopt its own regime, however this may be similar to the EU regulatory framework. In any case, businesses will need to comply with EU legislation if they wish to trade in the EU.
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DIGITAL
MATERIALS UPDATE
www.invibio.com
spy
INVIBIO POLYMER IMPROVES INTERBODY-FUSION OUTCOMES BUSINESS
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COPING MECHANISM Frost & Sullivan’s Gary Jeffery comments on the implications of Brexit for businesses both in and out of the UK
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heresa May set out an ambitious plan of maintaining a free trade relationship with the EU, while being outside the single market, and establishing preferential trade agreements with other global nations, notably China and the US, with Trump – a strong supporter of Brexit – promising to negotiate a speedy trade deal with the UK. Naturally the messaging was very pro-UK and even included some criticism of the EU’s institutions. Early European reaction is somewhat positive though. Europe’s leaders want to see the triggering of Article 50. A hard Brexit is perceived to work best for the EU as it doesn’t compromise its raison d’tre. It should create opportunities for continued collaboration and trading. A hard Brexit is also more likely to be agreed within the daunting two year time frame than a complex soft relationship. While Mrs May has attempted to provide clarity and certainty, the nature of our relationship postBrexit with the EU and other global trading nations is far from certain. After all, there
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are 27 other national views to take into consideration before a deal can be done. How will they respond to the UK’s notion of a hard exit softened by the continuation of preferential treatment? Our advice to companies (both in the UK and outside) remains the same as in June: Evaluate the impact of different Brexit scenarios (in terms of tariffs and barriers, immigration controls etc) on all aspects of your business value chain and business model. Look for new growth opportunities to offset future challenges in existing markets. Join forces with others in your industry to lobby your government to negotiate in your interests. The UK government seems to know about SUVs, aeroplane wings and financial services. Does it know about orthopaedics, therapeutics and the like? Businesses will find a way to cope with Brexit. By acting now you have the chance to help shape Brexit into a form that provides opportunity for you and your industry.”
arly clinical results presented by surgeons at the 2016 annual meeting of the North American Spine Society (NASS) have shown high fusion rates at six months as well as beneficial clinical outcomes, for most patients, when PEEKOPTIMA HA Enhanced is used for interbody-fusion devices.
The implantable high-performance polymer, from Invibio Biomaterial Solutions, combines PEEKOPTIMA and hydroxyapatite (HA), an osteoconductive material that enhances bone apposition, and is fully integrated. Previous studies by Invibio have highlighted that enhancing bone apposition on all surfaces of an interbody-fusion device may offer better integration and improved potential for spinal fusion. “The findings on first clinical cases for PEEK-OPTIMA HA Enhanced presented at the NASS 2016 annual meeting are demonstrating the Invibio goal of providing solutions that have the potential to improve clinical outcomes and advance bone apposition in interbody-fusion procedures,” said John Devine, Invibio Medical business director. “In addition, the results presented confirm that the partnerships we have forged with device manufacturers and surgeons are pioneering approaches that are leading to positive results for patients.”
DEVICE UPDATE
www.syncardia.com
heart of the matter: Spanish implant first
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medical team from Clínica Universidad de Navarra in Pamplona has successfully performed Spain’s first implant of the SynCardia temporary Total Artificial Heart. The 47-year-old patient, was suffering from severe dilated cardiomyopathy with biventricular heart failure. He had been on the transplant waiting list for more than a year due to difficulty finding a donor heart. “It was this or it was over,” he said. “My situation before the operation was pretty bad because I could hardly take a shower, tie my shoes and do many things. I could not even sleep. I would lie down on the bed and feel like I was drowning because my heart had no strength.” “The progressive worsening of the patient’s health left us no choice but to seek an urgent alternative,”
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said Dr Gregorio Rábago, director of cardiac surgery at Clínica Universidad de Navarra. “That is why we decided to implant the SynCardia Total Artificial Heart – so that we could stop his deterioration and recover his health until a matching donor heart is found.” Similar to a heart transplant, the SynCardia Total Artificial Heart replaces both failing heart ventricles and the four heart valves, eliminating the symptoms and source of endstage, biventricular heart failure.
DIGITAL SPY
DIGITAL NEWS
talking
Keeping it in the family:Publisher behind MPN buys medtech mag and show
POINT
www.med-techexpo.com | www.med-technews.com
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edical Plastics News readers can now take advantage of a new magazine and event for the medical device sector. Rapid News Communications Group (RNCG) has acquired the Med-Tech Innovation brand which sits alongside MPN Europe and MPN North America editions. Headed up by MPN deputy group editor, David Gray, the magazine will showcase the best new technology and innovation in the medtech sector.
“It’s exciting to be taking the helm of Med-Tech Innovation magazine” says David Gray
Gray said: “It’s exciting to be taking the helm of Med-Tech Innovation magazine, especially at such an important time for the industry. It’s no secret that the NHS faces a massive challenge to reduce admissions and treat patients more efficiently. Now more than ever, the medtech sector has a crucial role to play in achieving these goals. “Personally, I’m interested to see how digital devices continue their journey to the fore of modern medicine. Med-Tech Innovation gives pioneers a stage to showcase their achievement, but also, like any good B2B publication, it connects the industry, opening new avenues to networking.
“I can’t wait to hear from the industry - I’m familiar with many of the major players, having been part of the team that launched Medical Plastics News back in 2011. It’s particularly rewarding to be looking after a title which has always been ahead of the curve in this space - something which I hope to continue!”
FUN FUN PHOTO / SHUTTERSTOCK, INC.
The Med-Tech Innovation Expo sits alongside the magazine, offering those involved in this sector the opportunity to meet and do business with the UK and Ireland’s leading medtech companies and innovators – an industry currently worth an estimated £27bn. Taking place on 20 and 21 April at the Ricoh Arena, Coventry, this is the UK’s only medical device design, research, engineering and manufacturing event. Med-Tech Innovation Expo 2017 will bring together all stakeholders involved in the medical device innovation process, the exhibition showcases companies from the medical device supply chain alongside a conference that delivers insight, intelligence and education through a programme of expert speakers.
www.research.ibm.com
DIGITAL NEWS
Playing detective
Health tech that predicts disease
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enerally, the earlier the disease is diagnosed, the better. However, diseases like cancer can be hard to detect – hiding in our bodies before symptoms appear. Information about our health can be extracted from bioparticles in bodily fluids but this can be hard using existing techniques.
At IBM Research, scientists are developing lab-on-a-chip nanotechnology that can separate and isolate bioparticles down to 20 nanometers in diameter, and potentially reveal disease before symptoms show.
Comic timing At the University of California, scientists have created what they’re calling a Wolverine-inspired transparent, self-healing, conductive material with a range of potential uses including powering artificial muscles What exactly is the material? It’s an ionic conductor, so a material that ions can flow through. Chao Wang, one of the scientists working on the project combined a polar, stretchable polymer with a mobile, high-ionicstrength salt to create this unusual material. And it can power artificial muscles? Yes if electrically charged. It should also be useful for improving the life of batteries, electronic devices and robots. According to the university the material has a range of potential uses. It could allow robots the ability to self-heal should they fail and could extend the life of lithium ion batteries. It could also be used to improve improve biosensors used in medical applications. So what’s the Wolverine link? Wang admits to a life-long love of Wolverine, a comic book character who boasts the ability to self-heal. This mutant character with animal senses and an ability to regenerate, led Wang to develop a similar material. The result is a soft low-cost, easy to produce rubber-like material that stretch 50 times its original length. When cut the material can heal itself at room temperature, in fact, the university says that within five minutes of this happening, it can be stretched to twice its original length.
According to IBM Research, medical device labs-on-a-chip will become nano health detectives – tracing invisible clues in our bodily fluids and letting us know if we need to see a doctor. The goal is to shrink down to a single silicon chip all the processes necessary to analyse a disease that would normally be done in a lab.
“Creating a material with all these properties has been a puzzle for years,” said Wang, on the university website. “We did that and now are just beginning to explore the applications.” WWW.MEDICALPLASTICSNEWS.COM
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19/07/2016 16:33:45
NEWS FOCUS
ISO 13485
- ARE YOU READY? The medical devices and IVD industry is about to see the world’s most popular ISO standard for medical devices & IVDs quality management systems (QMS) revised. James Alexander, Procorre, explains how device manufacturers can prepare for the changes
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he medical device and IVD market is facing a significant regulatory challenge that places more emphasis on quality and safety through more robust quality management systems (QMS). The changes could prevent device manufacturers and suppliers accessing key EU markets if they’re found to be noncompliant. Put simply, this means any medical device (MD) or IVD that does not comply with the new ISO13485:2016 standard in the transitional time frame (ie. three years), or with the MDR and IVDR regulations (ie. three years for a MD and five years for an IVD) will be refused access to key markets. Medical device and IVD manufacturers cannot operate lawfully without compliance to the new ISO and MDR/IVDR standard/ regulations. The new ISO 13485:2016 revision places a greater emphasis on a risk based approach throughout the whole internal QMS and now extends throughout the whole supply chain and product life-cycle; including more robust controls on device usability, clinical evaluation and post-market surveillance requirements. Over the next three years, ISO13485:2003/2012 and ISO13485:2016 will co-exist, allowing device manufacturers, accredited certification bodies and regulators time to transition to the new standard (RAPS, 2016).
How can manufacturers prepare? Unfortunately, it’s no longer as simple as conducting your own audit and ticking a box to say your product conforms to the necessary safety standards. Getting
potentially hundreds of products compliant in time for the deadlines will be a significant challenge. Manufacturers have three main options: l Employ a full time quality assurance/
regulatory affairs (QA/RA) specialist – this is a long term solution but one that could be costly, depending on the size of the business l Purchase specialist QMS software and technical file templates, plus two days of initial training – these tools will assist with approximately 75% of the work; then you’ll need a specialist to conduct a gap analysis/pre-assessment and provide a report on the items audited l Engage a consultancy that will be able to provide fixed-term subcontractors to carry out a complete cradle-to-grave audit to certification service – this could be the most cost-effective solution and the package of support can be tailored to suit your individual requirements There are many steps a business must take to ensure each product is fully compliant, including: l An initial gap analysis to challenge their
products’ lifecycle(s) – this should take between two to three full days l Thoroughly review the gap analysis report to identify any major and minor nonconformances l Produce a complete project plan (using a Gantt chart for example) driven by the gap analysis and based on the business’s preferred timeline to get fully compliant QMS and technical files in place l Develop the QMS and technical files and deliver the project – this should take approximately 10 to 15 days of consulting
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support, depending on the size of the business and the classification level and number of products being audited l Roll out the processes with internal staff (i.e. implementation phase) and then introduce an independent lead auditor to do a pre-assessment and identify any corrective action needed l A rrange for a third-party auditing organisation (i.e. a notified body such as SGS, Lloyds, BSI etc.) to perform a certification assessment. l Upon completion, you’ll be awarded the new ISO 13485:2016 and CE mark approval certifications. If a business is considering bringing in a specialist team of device subcontractors, they may also decide to continue that relationship on an ‘outsourcing’ basis, to keep their QMS updated and manage potential complaints and/or reportable adverse incidents. The transition periods seem to give plenty of time to introduce the necessary changes, however the extent and complexity of the changes are significant, and it is expected to take between six and 18 months to fully upgrade the QMS and technical construction files, so we’re urging organisations to start the process as soon as possible to avoid having their devices removed from the EU market. To find out more about the ISO13485:2016 standard, and the ‘Recast MDR and IVDR regulations, download our medical devices whitepaper: info.procorre.com/medicaldevices-whitepaper.
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NEWS FOCUS
Chinese whispers Chinaplas 2017 will be held in Guangzhou from May 16 -19. Not only will more than 3,300 exhibitors introduce innovative solutions for the plastics industries, but there will be a range of events to meet the industry’s needs
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hinaplas’ events, in which industrial giants share their experiences and attendees gain insights into industrial trends, have always been the highlight of the trade fair, and have been well received by exhibitors and visitors alike. Following the theme of Intelligent Manufacturing, High-tech Materials, Green Solutions, the organiser of Chinaplas, will be simultaneously running three events during the exhibition: The Industry 4.0 Conference; Design x Innovation and the Medical Plastics Conference. Visitors can learn about new technologies and inspiring case studies, allowing them to hop on the bandwagon and understand market dynamics from multiple dimensions, explore more valuable opportunities for collaborations and expand networks to facilitate development.
According to Stanley Chu, chairman, Adsale Exhibition Services, China is still a developing country, and has not yet fulfilled the necessary conditions for industrial 4.0. “Only a few companies are making use of networking production technologies. Industry 4.0 is still a vision for many Chinese companies, but an attainable one, and attainable in the foreseeable future, if it is desired that something be done to cope with cost pressures.” Because of this Chinplas 2017 will be giving Industry 4.0 top billing.
The Medical Plastics Conference
Industry 4.0
There has been a growing demand for medical devices and in recent years, the rise of emerging markets and an ageing society has triggered a renewed growth of the medical device market.
China has become the world’s second largest national economy, and labour costs have risen sharply. It is no longer a low-wage cost country – all kinds of cost pressures force businesses to opt for more automation equipment and advanced technology in the production processes.
China’s healthcare industry offers huge potential. Due to low levels of technology manufacturers are looking for new solutions to existing production lines and cost pressures. New and better materials are the key to the future development of medical enterprises.
The Medical Plastics Conference has been a success for the past two years, receiving positive feedback from the industry. “At the Medical Plastics Conference, the technical experts shared the state-of-theart technology of the industry and analysed development direction of medical applications and solutions,” praised Shanghai Medical Device Industry Association. “At the same time, processing technology related to the production of precision medical polymer was introduced, offering enterprises knowledge of new materials and direction of development.” The previous Medical Plastics Conference attracted 600 professional visitors. Topics covered included the latest medical polymer materials, 3D printing in clinical and surgical model applications, medical laws and regulations, as well as application of surgical models. This year’s Medical Plastics Conference, will be held on May 17 and 18, and will bring together the upstream and downstream sectors of the industry to discuss the latest applications of medical plastics and cutting-edge production technology.
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The European event for medical device manufacturers and healthcare professionals to source technology and innovation Join us at Medtec Europe, the leading event for medical component and service providers with: • Plenty of opportunities to establish new and maintain existing business partnerships • Free access to high-level conference sessions for both exhibitors and visitors • Numerous chances to interact closely with healthcare and research institutions
• Several features which will highlight your presence at the show (Innovation Tours, Exhibitor Hub, Innovation Lab, and more) • Free access to networking events (Breakfast Meetings, Exhibitor Party, and many more)
4-6 April 2017 Messe Stuttgart, Germany
Book your stand with one call: +49 2241 95 97 0 or visit www.medteceurope.com/europe Other events include
Join the conversation with us: @MedtecEurope #MedtecEU
Book your stand!
www.medteceurope.com/europe
Contact:
Sales: medtec-sales@ubm.com Customer Service: medtec@ubm.com
NEWS ANALYSIS
Step and repeat
R
eusable medical devices are designed to be used to treat multiple patients with appropriate reprocessing between each patient. Initially, Knowing what’s these devices were to surgical involved when relegated tools, such as medical devices are scalpels, retractors, reprocessed can and suction tubes, help manufacturers and examination such understand what’s equipment, as stethoscopes needed in the design a n d blood and material choice. pressure cuffs, Stephen Spiegelberg, but now extend o endoscopy Cambridge Polymer tequipment, infusion Group, explains pumps, biopsy equipment, and respiratory equipment. Reprocessing of these devices saves hospitals between $0.5 to $2M annually through reduced original equipment purchasing and through reduction in tonnes of medical waste disposal1. The reprocessing is typically performed at either central facilities within hospitals or by third party processors. The reprocessing medical device market in the United States was $0.78B in 2013 and is anticipated to reach $2.58B by 20202. Reprocessing reusable devices involves cleaning and disinfection/sterilisation (or generally microbicidal process). The principle risk involves transferring organic soil and/or micro-organisms from one patient to another due to incomplete cleaning or microbicidal processing. In 2015, the FDA published a guidance document 3 for reprocessing medical devices. The document places the responsibility of reducing this risk on: The original manufacturers of the medical devices, who should design the devices for easy disassembly and cleaning, and for providing adequate instructions for cleaning; the reprocessors (either the central facilities at
the hospitals or third party reprocessors) for properly cleaning and microbicidal processing the devices, and for validating these processes; and The FDA, for examining the documentation on the previous two entities and ensuring the devices are safe and effective as originally manufactured and following cleaning. Reprocessing reusable medical devices involves three main steps, each of which is equally important in reducing risk of transmission of organic soils, such as blood, fecal soils, soft and hard tissues, as well as microorganisms, such as bacteria and fungi, to a patient. The first step begins at the clinical setting, or point of use of the medical device upon completion of the procedure. The reusable device should be separated from the disposable medical waste, wiped clean if possible, and placed in an appropriate container or transport so that it is kept moist and free of damage while it is transported to the cleaning area. Keeping the device from drying out is important, as it becomes substantially more difficult to clean dried organic soils. The second step involves cleaning the medical device. For some devices, some disassembly is required to expose internal channels to the cleaning process, and to remove parts of the device, such as electronics, that may be sensitive to more rigorous cleaning steps. The original equipment manufacturer should provide easy-to-understand directions for disassembling the equipment and for cleaning the part, including what size brushes to use and what cleaning agents are appropriate. The instructions should also include directions for reassembly. The cleaning should minimide transmission of organic soils from one patient to another, and prevent accumulation of soils during repeated uses/cleaning cycles. Additionally, the soil removal aids in microbicidal processing by ensuring the
sterilisation or disinfecting agents can contact the micro-organisms. The reprocessing instructions should be validated to ensure they will consistently reduce the soils and bioburden levels to safe levels. Whereas there are currently no standards for validating reprocessing procedures for reusable devices, several ASTM and AAMI standards may be applied4. These standards provide guidance on test assays to measure protein, carbohydrate, endotoxins, and other markers for organic soils, and also recipes for artificial test soils to challenge and validate the cleaning process. The third step in reprocessing is to disinfect or sterilise the device. The appropriate microbicidal process depends on the intended use of the device, along with the construct of the device. For critical devices where the device is in contact with blood or sterilised tissue, such as surgical instruments, sterilisation is required, often through autoclaves, ethylene oxide, or gas plasma. Semi-critical devices where the device is in contact with mucous membranes or non-intact skin should undergo high-level disinfection, normally with chemical disinfectants that reduce all microorganisms except for some bacterial spores. Non-critical devices which contact intact skin, such as pressure cuffs and bed rails, can undergo lowlevel disinfection. When designing a re-usable medical device, the equipment manufacturer selects materials and designs that take into account ease of cleaning and the number of times the device can be successfully reprocessed (reuse life). With thoughtful consideration of these factors, devices can undergo multiple processing steps, helping to reduce healthcare costs while still providing safe and effective treatment for the patients.
1 Association of Medical Device Reprocessors 2 Reprocessed Medical Devices Market - Global Industry Analysis, Size, Share, Growth, Trends and Forecast, 2014 – 202, Transparency Market Research 3 FDA Final Guidance: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling 3.17.15 4 ASTM F3127: Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices; ASTM WK50782 Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices (to be published late 2016); AAMI TIR 30: A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices.
WWW.MEDICALPLASTICSNEWS.COM
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COVER STORY
Decision time Francis Merlie, outlines when and with what drug, pharmaceutical manufacturers make the decision to use polymer in pre-fillable syringes
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olymers are a well-established container material for many drugs. The stability and inert properties, as well as a range of design options, make them an attractive choice. However, the material’s acceptance in parenteral packaging, especially for prefillable syringes (PFSs) is still debated. There is no such thing as ‘one size fits all’. While glass is still the preferred material for PFSs, polymer can also be a valid substitute for specific applications.
Acid test: Polymer tends to be the material of choice for dermal filler packaging such as hyaluronic acid
While both glass and polymer offer benefits for use in PFSs, for pharmaceutical companies it is often difficult to choose the right material to meet the needs of their drugs and delivery to patients. It very much depends on the drug to be used. German packaging specialist Schott, for example, has put together a list of questions that should be taken into account: l Does the drug require particularly
inert packaging materials?
l How important are design flexibility,
tight tolerances, and superior break resistance? l Do you have to consider integration with safety devices or autoinjectors? l Does the packaging have to be compatible with different filling machines and ensure easy regulatory pathways for drug approval? l And, most importantly, is the patient comfort considered and needs met appropriately?
Characteristics In recent years, polymer PFSs have grown in popularity, as in certain applications they fulfill the requirements better than glass. Polymer offers greater design flexibility while ensuring a low rate of breakage throughout the value chain. Plus, due to its material properties and manufacturing process, polymer is heavy metal and tungsten free, and also features low or no siliconisation. However, polymer has its own disadvantages. It has a much lower
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“In recent years, polymer PFSs have grown in popularity, as in certain applications they are a viable choice”
oxygen and gas barrier threshold than glass, increasing the potential for interaction with oxygen-sensitive drugs. Additionally, it exhibits an increased sensitivity to scratches if not handled correctly. Haze formation and discolouration could occur during sterilisation processes. Compared with polymer, glass shows certain weaknesses. The material is more vulnerable to breakage on the filling line or in the hands of users, if not handled properly. In addition, glass syringe components, as well as the manufacturing process, can lead to extractables and leachables which could interact with certain drugs. On the other hand, since glass is the most common material for PFSs, it’s already compatible with different filling machines and can easily be integrated into operations. Regulatory authorities have vast experience with it, which allows for a more streamlined pathway to drug approval.
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COVER STORY
Examples It’s worth manufacturers understanding the three Ps drug manufacturers bear in mind to assess whether polymer would be a better solution for glass – product needs, process requirements, and practitioner and patient needs. By breaking down the application into these areas, pharmaceutical manufacturers will be able to determine the right material for their PFS. Some examples provided by packaging expert from Schott will help understand where polymer is a suitable choice: l Heparin, an injectable anticoagulant,
is often used as a self-administration drug. Drug manufacturers need to take into account patient safety and easy integration with safety devices when developing PFS solutions. As a result, a glass solution continues to be the best option for heparin packaging.
l For dermal fillers (hyaluronic acid)
the end user assessment is quite different. Dermal fillers are used in cosmetic applications to reduce wrinkles and are often highly viscous substances. For that reason, these substances require packaging design flexibility that allows for a consistent gliding force to reduce the force of injection. In addition, polymer syringes have an integrated Luer Lock to prevent leakage and needle pop-off. As a result, polymer tends to be the material of choice for dermal filler packaging. Polymer syringes are more resistant to breakage than glass, and can be engineered for specific sizes, inner diameters, and finger flange designs while maintaining tight tolerances during manufacturing.
The stability and inert properties of polymer make it an attractive choice for a range of drugs
l Biotech drugs – stability is critical
for biopharmaceuticals, and for that reason, the drug’s packaging must be selected with care to prevent unwanted interactions. Glass has been a longstanding material in the packaging of injectable pharmaceuticals, especially biotech drugs, and is well known and accepted by various regulatory authorities. However, polymer PFSs could offer advantages for biotech packaging, including design flexibility, tighter tolerances, and break resistance for a better fit with autoinjectors.
+
To sum it up, while glass is the dominant material used for PFS applications, polymer might also be a viable choice for certain drug applications.
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OPINION
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Rachel Nagy, Owen Mumford explains why a combined approach makes all the difference when managing manufacturing and design projects
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ithin the m e di c al devi ce manufacturing sector, a product lifecycle can last on average anything from one to four years, by which time an idea has to pass from initial concept and design through to manufacture and mass market distribution. Timescales can be long and further lengthened by the requirement to fulfil market or industry regulations. This teamed with customer demands and the promise of a comprehensive completion of work within a specified timeframe, can heighten the pressure on the industry and those working within it. For medical devices, a project scope and its requirements can often be complex, requiring the input of multiple departments and functions. Project management is vital in successful deployment and can add significant value when effectively implemented. To meet a specified timescale within budget and reduce project risk, it is important to combine manufacturing and design in product creation and development. For a successful project completion, this integrated approach can make all the difference.
‘Design for manufacturing’
@melitek.com
A product lifecycle will begin with an initial design concept. A partnership of expertise between designers and manufacturers from this point onwards is important as this can allow for a more efficient and economic process. For
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OPINION
According to Rachel Nagy, Owen Mumford, to meet a timescale within budget, combine manufacturing and design in product creation and development
Joined up thinking a project manager, it is imperative to facilitate the communication between departments from the start of the project, reducing the risk of error or delay further down the line.
Design and prototyping Designers will build a prototype of the device through methods such as soft tooling or 3D printing which will allow the team to test the device there and then for any incompatibilities or inefficiencies. During prototyping, engineers can foresee any potential complications before the device hits production, whilst the real-world experience of manufacturers can influence the design stage. The earlier an issue is identified during the product development process, the more cost and time efficient it is to fix. This prevents the risk of a late technical discovery and reduces the time taken between device production and market delivery.
Market regulations and end-user factors Product efficacy is key in medical device manufacturing. For the project manager to deliver a device fit for the market, they must work closely with design and manufacturing teams to produce an easy to use and effective device whilst delivering against customer requirements. Part of this includes making a product fit for use and responding to market regulations. One such regulation is how biocompatible the device is, which must
be considered before the device is sent to manufacture. Cross-functional design and industrialisation engineers can help to identify the materials that may be appropriate to use and will fit regulatory, user and manufacturing requirements. This early cross-functional work ensures that industry regulations and manufacturing requirements are considered at the design stage of the project, reducing the risk of further design iterations later down the line.
The verification and testing phase Ahead of manufacturing, a designed device must pass through theoretical and physical testing. After the physical tests are complete, the performance reports are pulled together and compiled to evaluate performance. A close working relationship between the design and manufacturing teams is especially beneficial at this stage in observing and recording the results of verification testing and later resolving any issues identified.
Capabilities to innovate Cross-functional design and industrialisation teams are capable of seeing through the entire lifecycle of the product. They are able to add their expertise into the development stages that could be easily missed in a non-crossfunctional team arrangement. This allows the team to become more innovative with their design and manufacturing techniques and in
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turn offer the customer a new take on their brief and requirements. For the customer, this can be the key difference between taking a product to market and standing out against competitors.
Why this approach works A consistent team throughout the duration of the project comprised of all key disciplines along the way, can ensure smoother development, fewer surprises and better communication. For the project manager, there can be greater efficiency across differing stages of the product lifecycle alongside better control of costs as little to no outsourcing is required. As all stages are managed under the same remit, this also reduces the risk of multiple incompatibilities which may arise from multiple suppliers. From a customer perspective, using one team throughout the process can provide a continuity of knowledge, both in terms of understanding the end goal of the project but also the technical requirements to achieve the goal. In addition to this, a collaboration between design engineers and manufacturing helps to ensure the devices are reliably manufactured to a consistently high quality in production. This means that the product will be delivered to the customer faster. This efficacy, partnered with consistent manufacturing, will improve the product output and the long- term relationship with the customer.
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THE YEAR AHEAD
Caitlyn Scaggs Winning situation: According to Caitlyn Scaggs, Polymer Solutions, medtech companies could benefit, if Trump follows through with certain policies
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Sean Egan Forward thinking: 2017 will see the growth of implantable medical electronic devices, says Sean Egan, Nelipak
World in
he vibrant and innovative medical plastic device industry continues to develop materials, push the boundaries in design, and move forward with manufacturing processes that contribute to global health and well-being. Looking at recent events – eg the US election and its subsequent winner – there has been much discussion for the future of medical devices, particularly the scrapping of the medical device tax.
Advanced Medical Technology Association (AdvaMed), argued that the tax – which was created as a funding measure for Obama’s Affordable Care Act – harms job creation, deters medical innovation and increases the cost of healthcare. As a result, the organisation has called for the tax to be scrapped. As 2016 drew to a close, the 21st Century Cures Act, caused much discussion in the industry with its potentially significant implications for the medical device industry, such as faster device approval. Add to all this the rumours that Trump is looking to disband the FDA and the year ahead is looking highly interesting, whatever part of the world you live in.
Optimistic about the future Caitlyn Scaggs, Polymer Solutions, outlines how she sees recent events affecting the US medical plastics and device sectors: “The United States is expecting major changes with the election of Donald Trump. One potential change, which could have a positive impact on the medical device and medical plastics industries, is the full repeal of the medical device excise tax. Although there is currently a 20
Aaron Johnson, Small wonder: Aaron Johnson, Accumold predicts that medical devices will continue to shrink
moratorium on the medical device excise tax until December of 2017, it could be entirely eliminated, if President Trump follows through with policies outlined during his campaign. As a result, med tech companies may develop jobs and pursue innovation that they would have previously been deterred from because of potential implementation of the excise tax. Proposed reductions to the business tax rate, if implemented, will also free up revenue that companies can use to invest in growth within the medical plastics industry. These changes to the political and economic climate in the United States will no doubt impact the global economy and medical plastics industry. I’m optimistic the changes will be for the better.”
Across the pond The UK experienced similar political excitement when the country voted to leave the European Union. With terms yet to be agreed and the full extent of what Brexit will mean for both the UK and the rest of the world, the medtech industry has been guessing at what its future implications. Peter Brady, Ascensys Medical, shared his views on how Brexit might affect medical device manufacturers: “The Medical Devices Regulation (MDR) project is unlikely to be affected by Brexit and will likely come into force within the EU as planned and might even be introduced in the UK, certainly within the 2 years leading up to the deadline for exit. “As they come in to effect in the EU’s other member states, UK medical device manufacturers wishing to sell in this market will still need to comply with this regulation. “The UK is likely to aim for mutual recognition in negotiations with the EU WWW.MEDICALPLASTICSNEWS.COM
and this will mean that European medical device regulation will apply to the UK. This still needs to be determined by the next government, however.”
Intel Inside: Literally! Putting global politics to one side, what else are we looking at for the medtech sector in 2017? Micro moulding expert Aaron Johnson, vice president of marketing and customer strategy, Accumold is predicting that medical devices will continue to shrink. What he does see changing is the rate in demand. “The growing convergences in wearable technology coupled with pressures on making medical treatments more assessable and cheaper to the consumer will drive innovation. This type of innovation typically pushes the limits on size, features and functionality. This, I believe, will also drive more blurring-of-the-lines between micro electronics companies and medical device companies. Future headline: Intel Inside: Literally!” he says. Like Johnson, Seán Egan, group marketing manager, Nelipak Healthcare Packaging, sees electronic technology having an increased role to play in medical devices. “2017 will continue to see the growth of implantable medical electronic and bioelectronics devices to monitor and deliver patient care in both the hospital and home environment,” revealed Egan. He also sees mergers and acquisitions (M&A) still holding key significance going forward: “In the year ahead M&A activity will likely continue at pace as medical device manufacturers continue to scale operations
THE YEAR AHEAD
Bing Carbone Market forces: Bing Carbone sees medical device companies developing products for emerging markets
Christoph Lhota Numbers game: Christoph Lhota, Engel sees Industry 4.0 as being a key focus for his business in the year ahead
motion
Eric Resnick Smart thinking: Eric Resnick, West, sees big things ahead for smart packaging
After the political excitement of 2016, the world is viewing 2017 with interest and the medtech sector is no exception, says Lu Rahman
to deflect price pressures from hospitals managing patient care and costs in line with value-based Medicare. Increasingly, medical device manufacturers will manage hospital inventory directly as an outsourced solution.”
And for the injection moulding sector? According to Lhota the trend towards mobile point-of-care diagnostics is creating growth in this industry as more and more plastics are being used to produce the compact and lightweight devices.
The future is digital
“Overall, the most recent business mergers and acquisitions have led to a reduction of projects within the medical technology sector; project volumes, however, are on the rise,” he says.
As always the medical plastics world keeps a close eye on technology. The concept and benefits of digital health are widely viewed as the future by the medtech sector. Christoph Lhota, vice president, medical, Engel, sees Industry 4.0 as being a key focus for his business in the year ahead. He adds: “We have reached the stage of maturity; digitalisation and networking are becoming a part of daily life. More and more people are using health apps, consulting their physician by video conference, and using their smartphones as diagnostic devices. The faster we manage to solve the still existing challenges, including data security, the faster these technologies will become established worldwide, and will drive on-going development forward.” Beginning with the production of devices, Engel is using OPC UA to guarantee secure communications between systems, machines, and controls. “By rendering processes more predictable, stable and secure, Industry 4.0 is creating tremendous opportunities, most especially in the area of medical technology. In most businesses, a MES has long been the standard. Intelligent assistance systems with which manufacturing processes optimise themselves are now attracting more and more attention requiring new approaches in the area of validated processes,” he says.
Press print Technology features highly on Bing Carbone’s prediction list for 2017. According to the president of Modern Plastics, growth in 3D printing will continue on 2017 although recognises a potential flaw in this sector. “Many companies are investing heavily in 3D printing machines. This is great technology and advancement for many parts and applications but some companies have unrealistic expectations, believing this will replace most current manufactured parts. The problem many companies will face is once an investment in equipment is made, it is difficult to abandon, even if it does not produce expected results and performance.” Carbone says that due to the PEEK 2016 Federal Trade Commission Ruling he expects the medical market to continue to grow with PEEK applications now that FTC has opened the field for competition. “Price had been a limiting constraint for some applications to use PEEK but competition will bring down price, allowing many new devices to consider this highly desired material,” he adds.
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Looking ahead Carbone also sees continued medical device industry consolidation and an increase in demand for outsourcing as demand for medical devices and competition grows. He also sees that medical device companies developing new products to meet the needs of emerging markets in China, India and Kenya.
Perfectly packaged The drug delivery sector is always high on the medtech agenda. Eric Resnick, vice president & chief technology officer, West Pharmaceutical Services, makes his prediction for drug delivery packaging in the year ahead. “Biologic therapies continue to be the most influential driver in drug packaging. For example, some drugs must be stored at sub-zero temperatures, which can render traditional components and materials ineffective. This has forced the packaging industry to innovate components using new materials that safely contain the drug in new environments. “The Internet of Things is becoming ubiquitous, and we will see its influence in the drug packaging industry in the very near future. This could include leveraging smart packaging that shares data at the container and component level with other connected devices about any number of areas related to the drug product and packaging process,” he says. If global regulation does have a positive effect on the medical device sector and technology helps boost both manufacturing as well as end-user uptake, 2017 could be a significant year for medical devices and those in the supply chain.
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MATERIALS
Playing by the rules T
he patient’s wellbeing is the highest priority in regulatory systems for medical products and materials used in healthcare. Authorisation procedures are particularly time Bernd Elbert, healthcare consuming to ensure safety, with a detailed risk analysis, compliance with & diagnostics, Ineos regulatory demands, clinical evaluation Styrolution, outlines of the performance, effectiveness and the importance of efficiency, and finally, thorough quality regulatory compliance management system.
for styrenic materials in the healthcare industry
Plastics-based applications have to comply with the same rule and plastics can be found in countless medical applications, from small mobile measurement devices to drug delivery systems, to tubes and connectors and drip chambers for IV sets. Ineos Styrolution offers styrenic-based products aimed at healthcare applications. Our production environment delivers products that meet a range of compliance requirements and quality standards. For certain product lines, production protocols have been implemented so the company can offer two different levels of notification of change commitments (up to 12 or 36 months). Consistency in formulation provides another level of assurance to medical device designers that their efforts in qualifying new materials and obtaining the corresponding biocompatibility documentation will be valid for the years to come.
ABOVE | Material world: Medical drip chamber made with Styrolux development grade LEFT | To the point: Spike made with Novodur HD, by Fleima
Compliance testing of styrenics I believe that testing the raw materials against these common biocompatibility standards (ie ISO 10993 and USP class VI), elevates Ineos Styrolution above industry requirement. Medical device manufacturers are required by law to conduct these tests on their final application. Since we test our products against these same standards, medical device manufacturers have greater confidence when these products are used in their final application. They can reduce the risk of failure when introducing new applications in the medical market since their key raw materials are already compliant. Working with a pre-certified raw material would certainly lead to a reduction in time and cost for the application provider. Ineos Styrolution’s styrenic healthcare packages are designed for use in risk class I and risk class II applications. ABS grades such as Novodur HD grades and Lustran ABS are available with food contact statements in regards to the US (FDA) and European regulations. They meet the requirements of European and Japanese pharmacopoeia and have tested according to the USP Class Biological Reactivity Tests Class VI and relevant ISO 10993 standards.
What is next? Styrenics are popular materials for a range of applications due to their excellent flowability, impact strength, chemical resistance, hardness, softness and surface qualities. They combine excellent physical performance along with aesthetically pleasing attributes. We are current developing new materials for the healthcare market. One new grade will be tailored to meet the specific needs of IV drip chambers. It was designed to meet the ever-increasing demand for products that have superb bonding performance, have excellent flowability for multi cavity tools, and address the need of designers who are looking for an alternate grade to products commonly used in the market space. We are also looking at the first fibre-filled ABS which will not only meet the challenges of very demanding applications, but also fulfil regulatory requirements as mentioned above.
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MATERIALS
Making advances M
edical professionals are admired for their ability to perform in high-stress environments — balancing a patient’s urgent needs with maintaining detailed processes that prevent future issues. Aneta Clark, medical They are surrounded by tools that should packaging and help them in these situations but consider what happens to their process when tools advanced materials, shift from being helpful to being a burden. Eastman Chemical Often it isn’t even the tools’ fault. Rather, Company outlines how it’s the packaging that stymies quick to address industry responses.
needs for medical device packaging with advanced materials
Packaging can become the medical professionals’ worst enemy when difficult — at worst, hindering their ability to save lives. On the other hand, when done correctly, packaging helps medical professionals be the hero, executing very complex processes quickly. Some of the newest medical device packaging developed by Plastic Ingenuity, one of the largest custom thermoformers in North America, did just this. Made with a new material that offers more design flexibility than alternative offerings, this packaging met customer needs that also kept devices sterile and safe.
Packaging needs Medical professionals’ needs seem straightforward: They require recognisable, compact, intuitive and quick-to-open medical device packaging. Because of the quick access requirement, medical devices are often stored tightly in a single storage container. In addition, medical professionals prefer a recognisable package that doesn’t involve second guessing or confirming. By being labelled very clearly and distinctively in compact, easy-to-stack packaging, devices are much easier to access. Lastly and potentially the most important consideration – because package design isn’t consistent across devices – it should be intuitive to use and easy to open, saving medical professionals time and allowing them to continue focusing on the patient.
A case study All of these needs need to be considered while keeping devices sterile and safe. This means that medical device packaging designers have a lot to consider and the simplest way to fulfill all of these considerations is to choose the right material early in the design process. Choosing a material is exactly where Plastic Ingenuity started when designing new packaging for medical device products. The packaging company had used traditional rigid materials in the past, but it was considering new materials for more design flexibility. To identify the ideal material, the packaging company looked to extruder Pacur. The two companies discussed challenges and needs, and they determined Pacur’s PETG foam made with Eastman Eastalite copolyester presented some new capabilities for packaging.
distribution. For one customer in particular, this provided great value as the company needed a work in process (WIP) tray for international transit shipments. In looking at end-user industry trends, Plastic Ingenuity identified that many customers are packaging trays in pouches to simplify their packaging systems. Traditional rigid trays in a pouch can present abrasion issues, so this type of packaging has always been challenging. The foamed PETG presents soft flanges which, when placed into a pouch, don’t present the same abrasion risk. Thus, Plastic Ingenuity helped its customer develop tray/pouch packaging systems that perform better than traditional tray/pouch systems. In addition, Plastic Ingenuity also identified that the PETG foam allowed them to push the design envelope and they could execute challenging designs that go beyond traditional rigid materials. This allowed for designs with very aggressive geometry and undercuts. Deep undercuts with the more flexible material also meant that Plastic Ingenuity could address the end-user needs more effectively for certain applications. The undercuts kept devices in place, while the flexibility of the foam PETG allowed for easy product release. Addressing the need that medical devices must be recognised quickly, the colour stability of the material meant that the packaging was easily recognised even after exposure to ethylene oxide and gamma sterilisation. As an added bonus, the material had a nice clear glossy finish, helping devices fit the desired sterile aesthetic for medical environments.
A win-win Through taking end-user needs into consideration and working to identify the best material options early in the design process, Plastic Ingenuity went beyond traditional medical device packaging capabilities. Now, Plastic Ingenuity is creating work in process (WIP) trays, long catheter trays and trays with pouches — all addressing the industry needs outlined above. With some simple considerations, experienced collaborating companies and the right materials, medical packaging designers can meet industry needs, allowing medical professionals to shine. Eastman Chemical Company worked in conjunction with Jim Banko, Pacur, and Jason Crosby, Plastic Ingenuity, on this piece.
Perfect package: To identify the ideal material for its packaging, Eastman looked to extruder Pacur
Material considerations Starting long before medical devices reach the end user, packaging must protect devices throughout the supply chain. Knowing that device protection is a key design input, Plastic Ingenuity recognised that Eastalite provided a new capability to the marketplace. The Pacur PETG foam provided a cushioning affect that helped Plastic Ingenuity’s medical device customers reduce potential damage caused during WWW.MEDICALPLASTICSNEWS.COM
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A
集 團 品 牌 識 別 系 統 GROUP BRAND IDENTITY SYSTEM
品牌標誌
A01
Specializing In Custom Biomedical Polymer Compounding & Resin/Additive Distribution
【集團品牌標誌】
色彩意義︰
大東樹脂化學股份有限公司識別形象經過整體性的完整
企劃-定位，才能將其精神與理念以系統化的象徵性符
為適用於各種不同的廣告媒體及宣傳物上，又不失
號對外傳播。導入集團品牌識別系統能迅速塑造獨特的
集團標誌有形象標誌色彩的運用訂定規範，以便在
形象與文化，而集團品牌標誌乃識別系統之主軸，其為
不同的情況下使用。
未來品牌價值累積及保護之要件，明示大東的經營理
A.集團品牌標誌之標準彩色稿
念、精神內涵、產品功能，及服務特色的傳播工具。
B.集團品牌標誌之標準黑白稿
In partnership with C.集團單色使用規範
設計理念︰
集團標誌傳達了公司的對外形象與精神。統一的視覺符 號，更能加深客戶對公司的認知。
標誌於單色或反白時的表現方式。
為因應公司組織體改變、增加產品線及新的經營理念和 使命，特將意義重新探討，希望找出涵蓋過去、順應時 事、掌握未來的大東品牌形象精神之依據。
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QUALITY CONTROL
KEEP IT CLEAN! Alex Butler, MasterControl, looks at the importance of cleanroom quality and planning and maintaining operations in the manufacture of medical devices
D
uring the manufacturing process of medical devices it is important that contaminants are absent from the process – which is why cleanrooms are used. In addition to reducing the safety and effectiveness of the medical devices, contamination in a cleanroom could lead to a shutdown, resulting in the loss of significant amounts of money and time. Cleanrooms are especially important in the manufacturing process of plastic products that are becoming more prominent in medical devices. Impurities can cause defects in the products, which in turn can cause problems in the medical devices. Therefore, it is imperative that organisations have policies and procedures in place to maintain the environmental integrity of a cleanroom. In order to have a pristine cleanroom, organisations must first understand the threats that could cause contamination of a cleanroom. Micro-organisms, dust/smoke, unapproved equipment, inadequate environmental controls and human error are among the leading causes of contamination in cleanrooms. In general, some research has shown that cleanroom personnel contribute to approximately 80% of all contamination that is found within the cleanroom. In regards to plastics manufacturing for medical devices, injection moulds are a source of contaminants, especially if the molds are not properly maintained. Other cleanroom contamination sources specific to plastics are dust that is released during production and contaminated raw materials. There are some steps that companies can take to significantly reduce the risk of contamination, with a number of these preventative measures taking place outside of cleanrooms. Two good sources to look at before developing cleanroom policies and procedures are the Institute of Environmental Science and Technology recommended practices for contamination control and the ISO 14644 series of international standards for cleanrooms and associated controlled environments. A quick overview of some of the best basic cleanroom practices includes: l Developing a thorough cleanroom gowning requirements and procedures, such as what is to be donned and in what sequence.
l Ensuring the correct cleanroom
supplies are present and they are used properly. This is important for not producing quality products but to protecting cleanroom personnel. l Instituting cleanroom housekeeping procedures and schedules. This is common sense for not only cleanrooms, but for many different aspects many industries. Preventative maintenance is a good idea, especially for plastic mould injection equipment to reduce contaminants that are produced during the process. l Training personnel on behavioural
standards within the cleanroom environment. Carelessness and ignorance can lead to disaster. l Continuously auditing and assessing cleanroom procedures and making improvements as needed. As technology advances with new types of materials and new types of devices, cleanroom procedures need to keep pace with the contamination threats and sources that may arise. For organisations that need to build a cleanroom, they can get a headstart on contamination prevention with a sound facility design and floor-plan. One good tip from the Johns Hopkins Applied Physics Laboratory is to have a centralised air system that has air filters and fans to keep a predictable, clean airflow. A centralised air system also is important in regulating the conditions needed from drying the plastics. According to Controlled Environments, facility design evaluation is the first phase of the five-phase cleanroom validation process, which is performed
to ‘ensure that the design of the facility is fit for its intended purpose; to ensure that the facility, equipment, and environment meets User Requirement Specifications (URS)’. The other four phases are installation qualification, operation qualification, performance qualification, and the post-qualification monitor and control phase. The best cleanroom practices outlined earlier in this article play a key role in the cleanroom validation process. Of course, in addition to having a good cleanroom program, medical device manufacturers must provide documentation of their efforts, such as information of sterility in 510(k) submissions. In the spring of 2016, the Food and Drug Administration issued the Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile which has updated recommendations regarding sterilisation processes that should be in 510(k)s for devices labelled as sterile. As with all government regulations, it is strongly advised that medical device manufactures have a full understanding to of the new regulations, especially as it pertains to novel sterilising methods. An organisation using a novel sterilisation method will likely have to undergo a facility inspection by the FDA. Maintaining efficient cleanroom operations requires careful planning that begins before the cleanroom is built and implementing proactive policies and procedures.
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DRUG DELIVERY DEVICES
MATERIAL GAINS Markus Rössler, Raumedic outlines how silicone has a crucial role to play in the manufacture of medication and feeding pumps
T
hey are vitally important, make therapy possible, and they have become an integral part in hospitals or home-care settings: medication and feeding pumps supply patients with essential medication and nutrition. It is not only the right electronic and mechanical components that are crucial factors, but also the choice of materials for the pump segment. As in so many other areas of medical engineering, silicone plays a prominent role here. What properties must a product have in order to find a lasting place in the healthcare sector? What are the specifications? It must be biocompatible, and in many cases skin- and blood-compatible as well. Compatibility with common sterilisation processes is usually a key requirement. It should be resistant to heat and cold and display excellent storage stability while maintaining a consistent pump performance. It is also important that the product works reliably and provides precise pumping over long periods of time. For the use in hospitals and in the home-care domain this means always administering the right dose, whether with drugs or in feeding applications. Obviously, no substances should be released from the processed material. So-called ‘extractables’ can have a negative impact on drug formulations. It all adds up to quite a long list of product-specific requirements, which must in turn be met by the chosen material and its processing methods.
Single issue: According to Markus Rössler, Raumedic silicone injection moulding allows a range of features to be integrated in a single part
Silicone – an exceptional material Silicone is a perfect fit for the requirements of precise dosing and integrity when in contact with medications. Its physical/mechanical properties and the high degree of chemical purity in its formulation are decisive factors in this respect. Among its mechanical properties, the exceptional resilience of silicone plays a significant role. It has a direct influence on the tubing segment’s pump performance over the entire period of use. The developer can be sure that his pump will always precisely dose and deliver the prescribed and programmed quantity of medication or nutritional solution. To ensure this functionality, the pump segments are subjected to a qualification and validation process as part of the development phase. Upon customer request, each lot or batch manufactured can also be tested during the production phase. The segments are tested for their adherence to pump performance specifications on a custom-built test stand that has the corresponding production pump built in. To ensure that medications maintain the greatest possible purity, platinumcured silicone is often preferred over the use of a peroxide catalyst, due to its excellent extractables profile.
Silicone injection moulding vs extrusion The pump segments available on today’s market are manufactured in two differently manufactured ways. In terms of ‘pure’ production costs for fixed lengths, extruded tubing is generally more economical. However, customer and product requirements with respect to improved precision in delivery rates are becoming ever more demanding. Injection-moulded variants are therefore beginning to draw increased attention. The reason for this is that the diameter tolerance of tubing segments (for both inside and outside diameter) can be reduced by almost half, depending on dimensions and geometry. This fact has a direct positive influence on the dosing accuracy of individual pump segments in the range of 1%. Combined with
Fit the bill: Silicone is a perfect fit for the requirements of precise dosing and integrity when in contact with medications, says Markus Rössler, Raumedic
the development of the appropriate silicone material formulation, in terms of Shore hardness and the type and degree of crosslinking, extremely high dosing accuracies can be achieved for the pump system as a whole over the course of the product lifecycle.
Silicone injection moulding provides added value The intelligent use of silicone injection moulding technology allows for a range of features to be integrated in a single part. Previously these had to be provided by a more complex component. The advantages include: l no component-internal
assembly costs
l finishing work such as cutting
and stamping processes are no longer necessary l precision-shaped edges of the component - no sharp corners l material is highly particle-free l very narrow tolerances - very
high dosing accuracy
l section for air bubble detection l integrated connectors –
poka-yoke principle
l high degree of design freedom l improved anti-counterfeiting l maximum patient safety
When it comes to pump segments, the extrusion and injection moulding approaches each have their advantages and disadvantages.
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MICRO-MOULDING What kind of growth has Accumold seen of late? We’ve been fortunate to have had significant growth over the years. With that we have made investments in infrastructure to ensure we have the scalability and sustainability to meet our customer’s coming needs. Recently we cut the ribbon on a special 40,000 sq ft addition. It’s the second expansion in the last few years and we now have a total of 134,000 sq ft. of manufacturing space dedicated to micro moulding. The space is being filled with new machines and equipment. In the last year, we’ve also added over 100 new team members and we expect to reach 450 employees in the next 12-18 months. We like to say, ‘we’re huge in micro!’
What makes this addition so special? We built ‘Building Three’ as a hardened structure designed to withstand EF-5 rated winds. It was constructed with its own independent operational plant with back-ups and redundancies for continuous operations. This structure is unique to our dedicated industry. For many of our customers we are the sole source for their critical components. To provide an assurance of supply
we built this super-structure to offer this capability. We can run redundant presses in multiple locations in our factory without having to lose the main efficiencies of the vertical integration of our tool build and manufacturing processes. The structure was also built as cleanroom manufacturing space. This gives us a total of eight clean manufacturing spaces adding flexibility and capacity. We offer ISO Class-7 and Class-8 options depending upon the customer’s requests.
There’s a lot of interest in micro, what exactly is it? Micro moulding is the art and science of injection moulding small or micro-sized plastic parts or components. The main delineators between micro moulding and standard moulding, besides the size, are the complexity and tolerances often associated with these projects. It’s not uncommon for micro moulded parts to have features or tolerances well under 25μm (.001”). To date, Accumold’s smallest commercial part roughly measures 800μm x 380μm x 300μm. The easiest way to tell if you’ve designed a part for micro moulding is when your current suppliers no quote the project claiming it’s too small, too difficult, or not mouldable at all. In some cases,
that may be true but for more than three decades Accumold has produced parts that were once called impossible.
Is micro moulding limited to plastic-only parts? No. At Accumold we provide all-plastics parts but also a variety of value-added processes. Operations like lead-frame, insert-moulding or overmoulding are common. We have overmoulded metals, fabrics, glass, ceramics, other plastics and other customer requested media. In addition to these we also have experience with two-shot micro moulding, automated sub-assemblies and packaging.
What advantages does micro moulding have for medical manufacturing? The obvious advantage is centered on design. Just like consumer microelectronics, smaller, lighter, higher-functionality, more features, cost-reductions, etc, are all valid ways medical manufacturing can take advantage of micro moulding. Lessinvasive surgical tools, more complex catheter deployment/delivery systems or more sophisticated personal care/ diagnostic devices are just a few examples where micro technology, micro moulding and medical manufacturing intersect. The smaller the better is often the desired design outcome.
Making the world Ankeny, Iowa based Accumold has been very busy the last twelve months with expansion, growth, and innovation. vice president of marketing and customer strategy, Aaron Johnson, sits down with us to share Accumold’s thoughts on micro molding, medical manufacturing, and the future of the industry.
MICRO-MOULDING The more important advantage is quality. The engine that is necessary to build tools and produce quality micro moulded parts requires an attention to detail that is second to none. The precision needed to cut steel to microns, and process and measure the moulded parts to that same level of accuracy is the best platform for high-quality manufacturing. Be wary of suppliers that claim high-quality output but don’t have the infrastructure to drive it fully. There are no short cuts for highprecision output.
What other solutions does micromoulding bring for medical manufacturers? Medical manufacturing seems to be facing increasing pressures that many consumer industries have faced for a long time. The demands to reduce cost and/or add more functionality are increasing. Medical device manufacturers are looking for ways to add competitive advantage that often end up being difficult to produce. These challenges are putting pressure on some industry suppliers that are out of their reach, stifling creativity and perhaps leaving potential behind. Good design for micro moulding offers opportunities for more complex, featuredriven, smaller and smaller parts. These capabilities can lead to design advantages like part consolidation, reduced manufacturing processes, or better yet, adding new features that
lead to faster diagnostics, healing, or recovery.
What besides the moulded parts should medical manufactures consider? In the throes of asking, ‘can this even be made?’ the most often overlooked aspect of micro moulding for medical components is the time, cost and process of pre-production qualification runs. Micro moulded components are often complex parts with multiple critical dimensions that must be measured, validated and proven repeatable. Consideration for the design and implementation of a solid IQ, OP, PQ (Installation Qualification, Operational Qualification, Performance Qualification) process for these challenging parts should not be overlooked. From the beginning, in the Design for Manufacturability stage, discussions should begin for this often-required aspect of production.
What innovations has Accumold focused on recently? Recently our innovation team has been expanding our micro-moulder capabilities by enhancing our insert/ overmoulding moulding expertise. The ability to overmould very delicate media like glass, fabrics or other veryexpensive inserts is in high demand. Our team is asked regularly for something like, pick up a fragile, little 2mm speck, introduce it to the moulding
a smaller place will Accumold at g in be exhibit
est MD&M W44 Stand 28
TRIPLE WHAMMY: The Accumold Building Three, its 40,000 sq ft hardened structure addition Credit: Dan Cross
process, add a bit of complex plastic, inspect and package it, and do it all in one closed system – then do it a million times a month or more. Our innovation team collaborates closely with our automation & robotics team to integrate these custom micro manufacturing cells to be successful.
What does the future of medical manufacturing look like? The blurring of the lines between the Internet of Things (IoT) and medical device is the future. The convergence of these technologies will ask even more of the supply chain to produce increasingly complex and difficult devices. This demand will force greater reliance on strategic partnerships with key experts in micro manufacturing fields to accomplish these desired outcomes. We look for these partnerships. Our goal isn’t to be a job shop. The efforts required to build and produce high quality micro moulded components takes too much commitment to take lightly. As the pressures mount to do more with less space, we hope to be a trusted extension of our customers’ engineering team. This intimacy can lead to quicker development time and a partnership to a more robust production process.
Where’s the best place to begin? Start early in the design stage and with your ideal design. There can be many roadblocks pushing back on your idea. What might be possible, might get designed away, potentially losing competitive value in a design effort. Work this out with your expert supplier. I like to call our process, ‘conversationbased micro moulding’. Each project is different. There is no easy-button when it comes to evaluating and working through the design for manufacturability stage – especially when pushing the limits of size, geometry or tolerances. Accumold has spent the last 30 years pushing the limits of micro-injection moulding and we’re not about to stop innovating now. Together we can make the world a smaller place. What can you challenge us with?
SELECTION BOX: Examples of micro moulding DESIGN NEWS: Delicate media overmoulding. This flex-circuit and connector required careful tool design and processing so the expensive flex wasn’t damaged WWW.MEDICALPLASTICSNEWS.COM
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COATINGS
smooth L
ubricity in medical device technology is nothing new and has been a need since the early days of the industry in everything Josh Robertson, f r o m s i m p l e Compounding Solutions guide catheters complex outlines the place that t o articulating lubricious additives neural catheters, hold in medical device drug delivery manufacture systems and more. The need for lubricity is a function of design based on final performance in either an extruded tube or an injection moulded part. Surface friction between extruded tubes moving inside of one another can quickly derail any type of fine control in a catheter design and/or simply lock up other moving parts for instance a trigger or slide in a handle set. Many catheter designs are excellent candidates for PTFE liners to provide lubricity for devices travelling within. Very few companies provide such materials as a great deal of technical expertise is required and pricing reflects the complexity. The ram extrusion process, etching process and handling/shipping processes for exceptionally thin walled extrusions (typically .002å-.0005å) makes the cost justifiable. The technology is very well proven, effective and available. A PTFE liner is reflowed with braid or coils and an exterior thermoplastic jacket such as Pebax materials from Arkema. That liner inside the tubing provides the gold standard for all other material comparisons. PTFE powders and oils can also be compounded into many thermoplastics to provide lubricity. The powders can be effective, however, at Compounding Solutions we’ve learnt that this method generally requires a break-in phase. The polymer surface does have PTFE on it however the individual granules of powder must be effectively smeared across the surface and that requires polymer essentially being removed to flatten and press out the powder more evenly on the surface.
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Oils can help bridge that gap but it is not preferable. While only a bit of surface needs be sluffed off to impart lubricity, very few devices have the ability to undergo such preparation. In general, the more friction that occurs (break in) the better the powder loaded polymer performs1. This type of technology can be effective in some re-useable devices made in injection moulding applications however, catheter-based technologies are not well suited for compounded powders. Feedback from our customers has shown that the powders create bonding issues for the devices in everything from tipping operations to reflow processes. The PTFE powder on the surface makes bonding the soft tip of a catheter to the shaft a more difficult operation for heat bonding and at times adhesives. Conversely the same powder can help with the use of a tipping die because it helps with release from the die after the heat forming process. Another avenue is hydrophilic coating, which is generally applied to the exterior of a device but not exclusively. This is an exceptional provider of lubricity. Based on our testing and reviews nothing we have seen in the medical device industry can deliver the same effects. Adhesion of the coatings can be an issue however, expertise and effort has yielded good results for many companies. The providers of such materials and coatings provide excellent service and final results2. For exterior lubricous needs this is the gold standard. Costs are always a concern. The desire to reduce the costs involved in medical devices in general is not an unreasonable request. The lowest cost material is not necessarily the pathway to a low cost device. What most companies do not review is that a small increase in raw material costs for extrusion can greatly reduce the overall device cost. That can be achieved via dramatic decreases in scrap rates based on highly effective dispersion leading to reduced inclusions and smooth process profiles. Dispersion is the ability of any given compounder to spread the ingredients in a compound evenly and
achieve homogeneity. Pellet to pellet consistency is our hallmark. Such success is a result of switching from an existing vendor to Compounding Solutions materials as our dispersion techniques are the result of proprietary screw designs and machine operations. Technology improvements involved in medical interventional devices may be viewed as incremental and may not be clearly obvious unless viewed within the lens of the final cost benefit analysis for any given device. Using the example of PTFE liners in catheter based therapies is the first concept we reviewed while considering alternatives to well-known materials in the marketplace. The ability to extrude a very thin wall and reflow it into any given construction has provided a pathway to achieve an extremely lubricous inner surface and establish a baseline for performance standards. Compounding Solutions has developed Mobilize not as a replacement to PTFE but as an opportunity to achieve lubricous surfaces without the additional cost and the myriad of issues possible in laminate constructions. The opportunity to use a range of bonding techniques is open with Mobilize as we have yet to see any issues arise in heat or adhesive based bonding. Mobilize is an additive that is compounded into a range of plastics commonly used in catheter constructions such as PEBA, nylon, polyester and PE. The additive provides benefits with a minimal cost increase to the overall extruded material costs. Despite this minor increase in raw material cost the impact on the final device is an overall cost reduction because PTFE can be removed. Within the injection moulding realm, the same benefits can be seen in disposable/ single use devices due to Mobilize imparting reduction in frictional forces immediately. Knowing that new materials can be viewed as a pariah at worst or novelty to some at best we forged ahead with testing to help our customers understand Mobilize is a reasonable alternative to existing market options. Aging data was compiled and tested under ASTM conditions (See table).
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COATINGS
operators This kind of test simulates two things. Accelerated shelf life as would be expected during long-term storage in a warehouse, and the impact of high heat environments during shipping, storage, etc. Our experiment is representative of approximately one year of storage in a 72F warehouse, and three months of storage in a 115F shipping container. Injection moulded tensile and flex specimens were heat-aged at 45C in our oven for three months and tested at days 0, 30, 60 and 90. All test parts were made from the same lot of respective material.
Conclusion A range of additives/modifiers are available and each has an appropriate playing field. For the majority of costsensitive single-use disposables, additives such as Mobilize are an ideal balance between performance and cost. As we can see from the collected mechanical data on Pebax with and without Mobilize it has a minimal mechanical performance change relative to the base material without any additives. Pellethane and other TPU materials do see a greater degree of change. However, based on the application it could actually enhance the performance. Long term usage and storage of the additive in both polymers is stable and minimal change occurs between the Mobilize loaded material and the natural material. The addition of heat and UV stabilisers could benefit this longer term performance as well. A major observation is that tactile tests of TPU materials loaded with Mobilize are a dramatic change from the base resin. The tacky feel and clumping of tubing or other parts is essentially nonexistent which provides a side benefit as a manufacturing aid. The gold standards of the industry will remain as such and Mobilize provides another option the market can bring to bear for lubricous needs. 1.
http://www.rjchase.com/ptfe_ handbook.pdf page 29-30
2.
http://www.med-techinnovation. com/articles/articles/article/13/
Material
Material
Material
Material
Pebax 6333 5% Mobilize
Pebax 6333 SA01 MED
Pebax 6333 SA01 MED
Pellethane 2363-55D
Day
Young’s Mod (ksi)
Young’s Mod (ksi)
Young’s Mod (ksi)
Young’s Mod (ksi)
0
25.3
27.2
9.2
12.3
30
25.3
27.3
9.9
11.5
60
26.5
26.9
11.2
12.4
90
28.1
27.5
10.6
12.5
Day
Yield Stress (psi)
Yield Stress (psi)
0
2830
2790
30
3050
2880
60
3140
2990
90
3070
2910
Day
Yield Strain (%)
Yield Strain (%)
0
30
27
30
30
24
60
28
25
90
28
24
Day
UTS (psi)
UTS (psi)
UTS (psi)
UTS (psi)
0
5410
5250
7240
8040
30
4920
5150
7140
7600
60
5360
5360
7330
7550
90
5280
5260
6930
7680
Day
Elongation (%)
Elongation (%)
Elongation (%)
Elongation (%)
0
510%
380%
520%
450%
30
420%
380%
520%
430%
60
510%
400%
510%
420%
90
510%
380%
510%
420%
Day
Flex Mod (ksi)
Flex Mod (ksi)
Flex Mod (ksi)
Flex Mod (ksi)
0
48.7
49.7
16.9
17.2
30
49.5
51.3
19.9
18.3
60
50.6
55.4
21.3
21.4
90
50.6
55.6
20.4
Test Conditions Tensile – ASTM D638 – test speed 50mm/min, type I specimens Flex – ASTM D790 – test speed 5% deflection/min
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Cover note Dr B P van der Wal, Merit Medical Coatings and Charles Fields, Whitford Corporation, discuss the use of PTFE coatings in intravascular medical devices
T
here has been much discussion about PTFE coatings in the vascular medical device market. In November, 2015 the FDA issued a safety communication referencing the effects of coating delamination on intravascular devices on the heels of several reported incidences. For many years, PTFE coatings have been a silent partner, reducing friction every day in catheterisation procedures. They have become a ubiquitous, commodity finish on standard catheter components. Continual regulatory pressure in the chemical industry is always forcing change. Readers may recall that PFOA (Perfluorooctanic acid) was regulated out of the fluoropolymer manufacturing stream. This change had an effect on both coating performance and application requirements. This is not a new phenomenon. Coating manufacturers are constantly forced to deal with functional raw material changes including solvents, pigments, and resins. This does not mix well with the medical device market. While the medical device industry has processes in place to deal with material
change, it tends to be a time-consuming and often expensive undertaking to implement. These changes appear to be increasing as the global requirements for greener and safer products become a more serious driver. Current raw materials being evaluated include Chrome 6 (hexavalent chromium) and NMP (N-methyl-2-pyrrolidone). These are key materials in the manufacture of many of fluoropolymer (PTFE) coatings used on catheter components. Vascular medical device manufacturers will need to prepare to accommodate these coating changes to ensure the coating processes meet their end-use requirements. Merit Medical Coatings, whose wire coating facility is located in Venlo, Netherlands, has been taking a proactive approach addressing the regulatory pressures being placed upon the fluoropolymer industry. Dr B P van der Wal, senior engineer said: “The application of (PTFE) coatings to medical wires requires extensive expertise. The small size and flexibility of many medical devices make the coating process challenging and completely different from the coating process for flat
Numbers game: Pre-coated wire formed into a coil. The pre-coating process is generally used for high-volume processing
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COATINGS
ABOVE | Smooth operator: Whitford’s pre-coating line
and rigid substrates such as cookware. The significantly lower heat capacity for substrates such as wires necessitate completely different processing times and temperature.� There are two different approaches to the coating application: Pre-coating and post-coating. In the precoating process, the coating is applied to the substrate before assembly. In general, the pre-coating process is used for high-volume processing for which the substrate allows reel-to-reel processing. Pre-coating is a continuous process allowing for high coating speeds and a very consistent coating result for a full reel of material. For guidewires, this means the coating is applied to the wire in a reel-to-reel process before coiling. The coating therefore has to withstand all the forces used in the assembly process. For instance, the coating should not delaminate from the wire during coiling. This demands a lot from the coating because of the high forces applied to the wire and resultant deformation. Parameters such as the coating thickness are critical to make the coating flexible and strong enough. In post-coating, the catheter wire assembly processes have already been completed. Post-coating is a batch process and is selected if the substrate does not allow reel-to-reel processing, such as a wire with a ground tip. Post-coating also gives more flexibility to only coat part of the substrate. By masking part of the substrate, marker bands can be left on the surface. The subsequent dry film does not have to withstand the high mechanical forces
of coiling and other wire manufacturing processes. This does not make the coating application less demanding. With the pre-coating process coating adhesion failure would be observed during the assembly process. With the post-coating process coating adhesion failure would likely occur during patient contact if it is not caught during QA-inspection. This can be a dangerous situation placing very serious requirements upon the coating application processes. For fluoropolymer coatings, the non-stick property and good adhesion to the substrate contradict each other. Additionally, medical wires are typically constructed of reasonably inert metals, such as 304 stainless steel and Nitinol, For many years, further complicating the heating PTFE coatings have and pretreatment processes. been a silent partner, Often multi-layer coatings are reducing friction every used to get a good adhesion to the substrate using a binder day in catheterisation layer and a fluoropolymer rich top procedures. coat. Of course, this makes the coating application process more complex because multiple layers must be applied. There have been many new coatings developments in which one-coat systems have been developed giving the same effect: good adhesion to the substrate and a fluoropolymer rich topcoat. The coating process, however, hugely impacts the efficiency of this self-stratification process.
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r
e m y l o p e h t t Mee
S E O R E H SUPER erformance oks at high p lo n eo d ci u L what’s bury, properties – o Richard Pad er h er p su h e future polymers wit ay and for th available tod
A
s the aging population rises and healthcare costs spiral, the healthcare industry is under pressure to develop new devices that address increased incidence of chronic diseases and injuries while sustaining exceptional standards and properties – all at a reasonable cost. It used to be that materials conforming to the human body capable of withstanding extreme conditions were a thing of comic book superheroes. However, with the development of high performance polymers, materials that can withstand large impacts, radiation, harsh chemicals, extreme temperatures, stretch well beyond their original length and magically disappear, are a reality. Conventional polymers have been used in medical devices for decades such as ultra high molecular weight polyethylene (UHMWPE) frequently used in hip and knee repair, polymethyl methacrylate (PMMA) for bone cements and polyethylene terephthalate (PET) widely used in vascular prostheses and sutures.1,2 A high-performance polymer is a material whose properties such as strength, heat, and chemical resistance exceed those of conventional polymers. Of the different families and generations of polymers, polyether ether ketone (PEEK) certainly ticks every box due to its incredible properties such as high tensile strength (90 to 110 MPa) and melting temperature (>334°C (633 °F)) – over two and a half times higher than UHMWPE.1 Therefore, PEEK will stand up to the most demanding applications, repeated sterilisations and exposure to chemicals or drug formulations. Furthermore, PEEK’s biocompatibility, high lubricity and comparable properties to bone make it a candidate for long-term implants that require high resistance to wear. Subsequently, PEEK is a superhero material that performs
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incredibly well in almost every application, if cost is not a problem. While PEEK is a well-known replacement for metals in a variety of engineering applications due to its light weight and attractive mechanical properties, it is easy to overlook other beneficial properties of polymers such as flexibility. Therefore, another class of polymer with superhero characteristics is thermoplastic elastomer (TPE) that provides exceptional toughness and extensibility. TPEs are copolymers of two or more monomers providing both thermally stable crystalline segments interspersed with flexible amorphous regions creating an elastomeric or rubbery characteristic. 2 They can be easily melt processed in standard equipment and their physical or chemical properties can be tailored by varying the ratio of monomers or molecular linkages such as amide, ester, olefinic, styrenic or urethane building blocks. Therefore, TPEs can be used for applications from catheters and surgical instruments to medical bags and tubing.
So far, we have introduced high strength polymers with exceptional extensibility which can fulfill a range of medical device applications. However, perhaps one of the most inspiring developments branches from the arrival of synthetic bioresorbable polymers. These provide support to damaged or blocked tissues while slowly degrading over time allowing the body to restore normal function. Common bioresorbable polymers include poly(l -lactide), poly(glycolide), polycaprolactone and their respective blends or copolymers which are all well known for their biocompatibility. Subsequently, these materials degrade via hydrolysis upon contact with water in surrounding tissues.3 Commercially available biodegradable polymers are used for medical devices such as sutures, tissue staples, stents and drug-delivery devices as well as being candidate materials for scaffolds in the exciting, expanding field of tissue engineering. These materials signify an evolutionary trend in the use of polymers for medical devices. While the first generation of medical polymers such as UHMWPE, PMMA and PET were designed to be inert and minimise the threat of an immune response, the second generation of medical polymers, such as PLA, PGA, PCL were designed to be biocompatible or bioresorbable. There is growing interest in materials that stimulate a specific cellular response namely, third generation biomedical materials.4 It is important to note that first and second generation materials can support the development of third generation biomaterials by promoting cell adhesion and growth through immobilisation of proteins or incorporation of bioactive compounds. For example, to improve the biological activity of PEEK, researchers are exploring the incorporation of bioactive particles such as hydroxyapatite (HA) onto the surface of implants to accelerate bone regrowth and improve attachment between the implant and surrounding bone tissue.5 Furthermore, HA has been incorporated into super elastic polycaprolactone or poly(lacticco-glycolic acid) bioresorbable polymers for tissue scaffolds that support cell viability and proliferation.6 This next generation of biomaterials has superhero properties due to their ability to enhance human health and wellbeing. As a polymer scientist, I am fascinated by the diverse range of polymers that can be produced from blends, copolymers or synthesised from entirely new chemistries. It is reasonable that
Figure 1. Chemical structure of PEEK
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HIGH PERFORMANCE POLYMERS
material selection for a specific application can be one of the most daunting tasks encountered by medical device designers and engineers. There are seemingly limitless options to choose from as each polymer is part of a large ancestry of subtle changes in molecular make-up that creates notable variations to their macroscopic properties. So where should I start? Material selection requires an understanding of polymer characteristics and how chemistries and morphologies influence their inherent properties. Polymers are characteristically different from their ceramic and metallic alternatives because of the long polymer chains that make up their unique structures. These long polymer chains are typically arranged in an entwined, random order similar to the state in which you find your Christmas lights at the start of the holiday season. However, domains of ordered, adjacent chains packed tightly together in a repeating pattern may also form resulting in polymers with semicrystalline morphologies. As such, polymers are viscoelastic materials with distinct time dependencies, melting points and transition points which determine whether the polymer acts like a flexible, rubbery material or a brittle glass. It is a polymer’s unique chemistry that separates it from the diverse range of alternative polymers. So, which polymer should you use? The choice of material is closely connected to the properties required for the given application. Therefore, it is essential to create a comprehensive list of requirements for the medical device that underpin key constraints such as regulatory restrictions, operational use and mechanical properties as highlighted in Figure 2. Perhaps one of the most crucial considerations for a medical device is whether the polymer needs to be biocompatible. Clearly, if the polymer is going to be in contact with tissue or fluids inside the body for long periods of time, exposure to potential process contaminants, residues, leachables and degradation products must be evaluated. Finally, the mechanical properties, dimensions and lifetime requirements of the device will have a substantial influence on the range of polymers suitable to achieve the required specifications. Selecting a polymer material based on these factors will be determined by traditional characteristics such as strength, stiffness or impact resistance as well as sorption, temperature deflection properties and chemical resistance which are required for a variety of climate conditions, including during transportation and storage. While polymer structure and chemistry impact their material properties, it is also important to consider how manufacturing processes influence stability. There is a range of manufacturing techniques available for medical polymers such as injection moulding, blow moulding and fibre formation. However,
polymer structure and process conditions are intimately connected – polymer structure influences the process parameters needed to construct the material into a useful form, and process conditions can alter polymer structure to either enhance their properties or less conveniently, adversely affect them. Polymer processing is an art form, with an array of controls that need to be tuned to the inherent properties of the polymer material and the final requirements of the medical device. Cost determines which materials and processes will be selected for a given application. Cost is largely driven by volumes and whether the device is single-use or implantable. In summary, the classical definition of a highperformance polymer is a material that has a high service temperature, resistance to chemicals and mechanical strength. However, we have a range of polymers with distinctly unique characteristics from high strength to exceptional extensibility or the ability to bioresorb. Therefore, the definition of high performance is perhaps more subjective than initially presented and strongly related to a polymer’s performance for a specific application. We encourage developers to consider the factors described above and the range of materials that will provide the necessary regulatory, mechanical and biological properties for the specific use. In the long run, selecting the right material for the right application will permit its optimal performance during use at the lowest overall cost.
Figure 2 Rational material selection process
References: Sastri, V. R. Plastics in medical devices: Properties, requirements, and applications. Amsterdam, Elsevier/William Andrew, 2010 Domb, A. J and Khan, W. Focal Controlled Drug Delivery. Springer US, 2014 Zhang, X. C. (2016). Science and Principles of Biodegradable and Bioresorbable Medical Polymers: Materials and Properties. Woodhead Publishing, 2016 Hench, L. L. Third-Generation Biomedical Materials. Science. 2002, 295 (5557), 1014–1017. Durham, J. W. et al. Hydroxyapatite Coating On PEEK Implants: Biomechanical And Histological Study In A Rabbit Model. Mat. Sci. Eng. C. 2016, 68, 723-731. Jakus, A. E. et al. Hyperelastic Bone: A Highly Versatile, Growth Factor-Free, Osteoregenerative, Scalable, And Surgically Friendly Biomaterial. Science Translational Medicine. 2016, 8, 358, 358ra127
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TAKING CONTROL
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edical device manufacturer Tegra Medical faced profit erosion as costs went up and customers demanded price cuts. Deploying Tegra Medical three collaborative robot arms from Universal explains how the doubled throughput, installation of freed up 11 full-time Universal Robots positions and kept up with customer demand.
“The new collaborative class series robots had just come out, when we started looking into automation. We really thought that was something beneficial as we wanted to put a lot of our operations together in mini-cells in confined work spaces where operators have to interface with the automation. Erecting big cages if it was a regular industrial robot wouldn’t have been advantageous to what we were trying to do,” said Blenkhorn.
At Tegra Medical’s main production facility in Franklin, Massachusetts, a novel robotic cell is working next to employees, producing components for a meniscal repair device.
Before Tegra built the UR10 robotic cell, it started out with two smaller cells each tended by a UR5 robot arm, UR10’s ‘little brother’, featuring same 4 mils repeatability but with a reach of 33.5 inches. The UR5 picks up the blank from the feeder and then moves it between the lathe, the grinder and the conveyor in a cycle that now takes only 10 seconds compared with the 22 seconds it took with manual labour.
had doubled production and enabled the company to keep up with customer demand
“It’s an unusual for us and it’s unusual in the industry to have a mixed model cell like this feeding three different products simultaneously in the same machining cycle,” said Hal Blenkhorn, director of engineering at Tegra Medical. The robot arm performing the machine tending is a UR10 from Universal Robots. With a reach of 51 inches, it picks up blanks from three different hoppers, feeding two of them into two grinders while the third product goes into a lathe where an internal cutting tool creates a bevel edge on the end of the repair device. According to Paul Quitzau, senior engineering manager at Tegra, setting up the machining cycle is about timing: “The UR10 starts with the slowest cycle first, then goes on to the next. It’s like popping bread in the toaster and making your eggs in the interim, then having everything finish at the same time.” This mixed model cell unusual in the industry, and the fact that the robot can operate with no safety guarding next to employees is a radical break from traditional industrial robots that stay fenced off from humans.
“We were looking at cost, accuracy, ease of implementation and ease of use. The Universal Robots seem to nail it in all those areas,” said Blenkhorn.
Double whammy: Tegra Medical has installed Universal Robots and doubled production
the process. We just changed the handling of components in-between the processes. That was a huge win for us,” said Blenkhorn. “We can offer our customers the price reductions that go with that, we can keep up with production demand, and we’re not really burdening anyone with additional qualifications and validation activities.”
Nobody loses their job to a robot
The UR robots are classified as collaborative due to their built-in safety system that makes the robot arm automatically stop operating if it encounters objects or people in its route. This feature enables humans and robots to work side-by-side without the fencing that’s usually required with traditional industrial robots.
The tangible benefits of the robot implementation is the doubling of throughput and the freeing up of 11 full time positions. “Obviously when you mention robots, people think they’re going to potentially lose their job. In 2014, our CEO told us that our facility was going to become the robotics centre of excellence for the Tegra Medical platform – but that nobody would lose their job to a robot,” said Blenkhorn.
The types of activities Tegra wanted to automate first were the high volume, repetitive motion type processes.
Instead, Tegra has repurposed the operators into other processes and operations to keep up with company growth.
“Being in the medical industry, we were up against process change controls. We can’t be changing our process without notifying our customers and going through validation activity. But by simply replacing the operator with the robot, we essentially didn’t change
“When we see an operator that does nothing but load a part every 10 or 20 seconds, we try to put more value add to them by training them new skills, whether it’s a different operation or by having them become the robot supervisor in that area.”
Built-in safety protects operators
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Five things about medtech… According to Visiongain, the global medical device sector market will reach $398bn (£323bn) in 2017.
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Wilson Greatbatch was the brains behind the implanatable pacemaker. This revolutionary little device transformed many lives since its creation in the 1960s. Greatbatch died in 2011 aged 92.
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The digital health market is big business and looks set to hit the $379bn (£307bn) mark by 2024
Last year’s Medica show pulled in 127,800 visitors. The next event will take place on 13-16 November 2017.
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“You have basically a little watermelon covered in grease,” Dr Peter Coelho, CEO of MedicalCue, on why a new kind of sensor (rather than the standard adhesive sensor) is needed to monitor asphyxia in newborns
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02:2017 Q: What’s going to be big in 2017? A: All things digital Thanks to our sister site Digital Health Age, we get to keep on top of the connected health sector here at MPN. It’s an exciting and fastmoving industry offering huge opportunity for medical device manufacturers. If you kept an eye on this year’s CES you’ll know that once again digital health was big news. With an array of devices designed to improve the healthcare process for professionals and the patient, it’s hard to select the best.
China stays local
One that really stood out was Cambridge Consultants’ smart packaging that actually talks to you! This interactive packaging design aims to improve compliance and the patient experience. Medical leaflets can be complicated but obviously are vital if you’ve been diagnosed with a chronic disease and need to learn how to inject yourself with medication. This packaging lets the user trigger audio messages using touch-sensitive paper packaging. This gives patients guidance and support to help overcome any initial fears of starting a new treatment. The ‘talking’ packaging is designed to help them through those first few weeks and avoid any danger to their health.
China’s medical device industry is ushering in a new policy to boost localised medical device production.
process, and to help boost the development of the Chinese medical device industry.
The publication of the China Food and Drug Administration’s (CDFA) Guidelines for the Preparation of Special Reports on the Application of Innovative Medical Devices aims to encourage medical device innovation, and promote the practice of new medical device technology.
The medical device industry represents a massive market in China with only 14% of the country’s local market’s share consisting of medical devices and equipment. In comparison, medical devices and equipments in developed overseas markets account for 42% of the overall market size of pharmaceuticals and devices/equipment.
It attemps to help China’s medical device localisation
Check out... Not strictly a medical plastic but with its germ-repelling properties, MPN tested the new polymer £5 note to see what nasties are really lurking! Take a look at what we found: bit.ly/2jfv8tK 42
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A new generation takes shape.
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