MEDICAL PLASTICS news
+ ADHESIVES ARE BOOMING - IS IT DOWN TO DIGITAL HEALTH? FOCUS ON EXTRUSION EMERGING MARKETS
Living proof: Mouldmaking brings innovation to medical manufacture ISSUE 38
Sep-Oct 2017
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We Deliver Global Results Our full design, manufacturing and assembly capabilities create total value solutions leading to cost improvement, reduced investment and increased efficiency. Regardless of location, we achieve superior consistency by employing a common manufacturing footprint for all of our global facilities. And when client needs expand, our facility expansions mirror customer expectations. This logistical strength, along with the diversity of our employees, makes us the specialists in the development and manufacture of injection molded components. Carclo is truly a global operation able to supply multinational companies with a consistency that others just can’t match.
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CONTENTS Sept-Oct 2017, Issue 38
Regulars
Features
5 Comment
21 Adhesives come of age A special focus on medical adhesives and how this technology is booming
36 Clean living Organic and biodegradable, bioplastics can be used in a range of biomedical applications
30 Make the connection What’s the technology that medical device manufacturers can benefit from, asks Lu Rahman
39 Talking tech The orthopaedic biofabrication project with polymers at its heart
6 News focus How bacteria tests using smartphone screens offer a breakthough in medical device coatings 8 Digital spy 11 News analysis How far do the medical device rules affect health-related apps? 16 Cover story Schöttli explains how clever mouldmaking solutions help meet the growing demands of medical manufacturers
32 Matter of substance Ineos Styrolution examines styrenic solutions for the medical device sector
40 Weighing in Trelleborg Sealing Solutions and Davis- Standard look at extrusion issues
35 It’s a small world Cikautxo Medical explains why silicone parts are moving to micro manufacturing
46 10:2017
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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 graphic design | matt clarke publisher | duncan wood Medical Plastics News is available on free subscription to readers qualifying under the publisher’s terms of control. Those outside the criteria may subscribe at the following annual rates: UK and Europe: FREE North America: £249 Rest of the world: £249 subscription enquiries to subscriptions@rapidnews.com
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The plus and the minus
P
lastic has taken a bit of a beating recently. And maybe not without reason. The news that water supplies across the globe have found to have been contaminated with small amounts of the substance have been alarming to say the least. Plastic has become a vital material for the manufacture of so many of the items we take for granted. From toys to bottles to medical devices, it is a substance of choice and contributes to a host of products that benefit from its material properties. However, of course that doesn’t mean we shouldn’t be responsible – as manufacturers or consumers – in the way we dispose of it or the way we encourage other to dispose of it. While medical plastics hasn’t been singled out in the study by Orb Media that found plastic fibres in not only water but also beer, sugar and honey, of course the sector runs the risk of being tarred with the same brush when the national press gets hold of this type of story. I agree that we need to keep plastic out of the water supply as much as possible. But we also need to look carefully at the amazing things polymers can do and are doing. At the time of writing we‘ve just had news of how scientists are using biodegradable polymers to deliver multiple vaccines in one jab. Researchers at the Massachusetts Institute of Technology developed containers that are hollow, injectable and made of polymer microparticles. The containers can be filled with a drug or vaccine and are designed to break down at various points in time to release the contained fluid.
The microparticles are made of a biocompatible, FDA approved polymer and resemble miniature coffee cups, which before are then heated slightly so that the cups and the lid fuse together to seal the drug inside. This breakthrough could have huge repercussions if further development takes place. Just a few months back we ran the story about the ‘artificial womb’ device that offers significant potential for keeping premature babies alive. The plastic bag-like device is filled with amniotic fluid that acts as an ‘artificial womb’ has been tested successfully in a study using unborn lambs. The womb-like environment designed by paediatric researchers could transform care for extremely premature babies, by mimicking the prenatal fluidfilled environment to give the tiniest newborns a precious few weeks to develop their lungs and other organs.
“
Plastic has become a vital material for the manufacture of so many of the items we take for granted
“Our system could prevent the severe morbidity suffered by extremely premature infants by potentially offering a medical technology that does not currently exist,” said study leader Alan Flake, a foetal surgeon and director of the Center for Fetal Research in the Center for Fetal Diagnosis and Treatment at Children’s Hospital of Philadelphia (CHOP). It’s pretty amazing stuff. While we need to recognise the bad press plastic has received and act on it positively and proactively, let’s also remember the great things going on that benefit many of us on a global level.
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NEWS FOCUS
HOW BACTERIA TESTS USING SMARTPHONE SCREENS
may offer a breakthough in medical device coatings Conducting plastics found in smartphone screens can be used to trick the metabolism of pathogenic bacteria, report scientists at the Swedish Medical Nanoscience Center at Karolinska Institutet in the scientific journal npj Biofilms and Microbiomes
B
y adding or removing electrons from the plastic surface, bacteria may be tricked into growing more or less. The method may find widespread use in preventing bacterial infections in hospitals or improve effectiveness in wastewater management. When bacteria attach to a surface they grow quickly into a thick film known as a biofilm. These biofilms frequently occur in our surroundings but are especially dangerous in hospitals where they can cause life threatening infections. Researchers have now aimed to address this problem by producing coatings for medical devices made from a cheap conducting plastic called PEDOT, which is what makes smartphone screens respond to touch. By applying a small
voltage, the PEDOT surface was either flooded with electrons or left almost empty, which in turn affected the growth of Salmonella bacteria. “When the bacteria land on a surface full of electrons, they cannot replicate”, explained principal investigator Agneta Richter-Dahlfors, professor at Karolinska Institutet’s Department of Neuroscience and director of the Swedish Medical Nanoscience Center. “They have nowhere to deposit their own electrons which they need to do in order to respire.” On the other hand, if the bacteria encountered an empty PEDOT surface, the opposite happened, as they grew to a thick biofilm.
“To begin with, we can coat medical devices with this material to make them more resistant to colonisation by bacteria”, said professor RichterDahlfors. In the future the research team will work to integrate this technology into devices that could one day be implanted into patients to keep them safe when undergoing medical procedures or having devices implanted. The study was financed by the Swedish Research Council, Vinnova, Carl Bennet AB, and the Swedish Medical Nanoscience Center.
“With the electrons being continually sucked out of the surface, bacteria could continually deposit their own electrons, giving them the energy they needed to grow quickly”, said professor Richter-Dahlfors. This left the research team in a position where, at the flick of a switch, they could either abolish bacterial growth or let it continue more effectively. This has many implications for both health and industry.
6
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Publication Salvador Gomez-Carretero, Ben Libberton, Mikael Rhen, and Agneta Richter-Dahlfors. “Redox-active conducting polymers modulate Salmonella biofilm formation by controlling availability of electron acceptors”. npj Biofilms and Microbiome, online 4 September 2017. doi:10.1038/s41522-017-0027-0
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DIGITAL SPY
DIGITAL
DIGITAL SPY
spy
www.qub.ac.uk The shape of things to come: Flexible battery for implants
DIGITAL SPY
Experts at Queen’s University Belfast have designed a flexible and organic alternative to the rigid batteries that power-up medical implants
www.interplasuk.com
Mediplas@Interplas - WHAT’S ON Your guide to the Mediplas@Interplas session on 27 September at the NEC, Birmingham
Innovation Happens Here
Who Aaron Johnson, Accumold What Chair Where Main stage When 1.30-3.30PM 27 September Why To hear some of the latest thought leadership and expertise in medical plastic and device manufacture Session 1 1.30pm Jane Gardner, Axion Consulting, for PVCMed Alliance Title Recovering Single Use PVC Medical Devices from Hospitals in the UK Gardner will be sharing her expertise with visitors on how healthcare can contribute to the circular economy. It’s always important that manufacturing companies consider their social and ecological impact and we’re seeing increasing numbers of businesses wanting to know more about the circular economy and how to be part of it. Session 2 2.00pm Dan Clark, Centre for Healthcare Equipment and Technology Adoption (CHEATA) Title Getting your medical device NHS ready Clark will be explaining how businesses can make their medical device NHS-ready. This type of sound advice is crucial to medical device designers and manufacturers who need to look to the NHS from the offset to achieve long-lasting business success.
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Session 3 2.30pm Professor Alexander, The London BioScience Innovation Centre Title The next generation of plastics for biomedical application will be based on carbon-based nanomaterials Seifalian, director & professor of nanotechnology & regenerative medicine, the London BioScience Innovation Centre, on board is a major coup. His medtech credentials are exemplary and he boasts the development of the world’s first synthetic trachea as one of his many achievements. He was awarded the European Life Science Awards winner for this as the most innovative product in 2012.
C
urrently, devices such as pacemakers and defibrillators are fitted with rigid and metal based batteries, which can cause patient discomfort. Dr Geetha Srinivasan and a team of young researchers from Queen’s University Ionic Liquid Laboratories (QUILL) Research Centre, have now developed a flexible supercapacitor with a longer cycle life, which could power body sensors. Flexible device The flexible device is made up of nonflammable electrolytes and organic composites, which are safe to the human body. It can also be easily decomposed without incurring the major costs associated with recycling or disposing off metal based batteries. Dr Srinivasan added: “At Queen’s University Belfast we have designed a flexible energy storage device, which consists of conducting polymer - biopolymer composites as durable electrodes and ionic liquids as safer electrolytes. “In modern society, we all increasingly depend on portable electronics such
Rebecca Smith, national territories manager and Oliver Barker, territory account manager, Connect 2 Cleanrooms Title The Fundamentals of Cleanrooms in Design and Operation This seminar focus on automation, localisation, risk management approach and how cleanrooms can help to alleviate challenges within the plastics industry.
“In medical devices such as pacemakers and defibrillators there are two implants, one which is fitted in the heart and another which holds the metal based, rigid batteries - this is implanted under the skin. “The implant under the skin is wired to the device and can cause patients discomfort as it is rubs against the skin. For this reason batteries need to be compatible to the human body and ideally we would like them to be flexible so that they can adapt to body shapes. “The device we have created has a longer life-cycle, is non-flammable, has no leakage issues and above all, it is more flexible for placing within the body.” The organic storage device could also provide solutions in wearable electronics and portable electronic devices, making these more flexible.
DIGITAL LAUNCH
Seifalian’s presentation promises a valuable look at the future of materials in biomedicine and how the next generation of plastics will be based on carbon-based nano materials. Session 4 3.00pm
as smartphones and laptops in our everyday lives and this trend has spread to other important areas such as healthcare devices.
www.upm.com Labelled with care: Compliant device labels launched
U
PM Raflatac has expanded its range of compliant pharmaceutical and healthcare label materials for the medical device and healthcare industries. Today there are over 500,000 types of medical and in vitro diagnostic medical devices available in the EU, with a medical device meaning anything from a contact lens or sticking plaster to an x-ray machine or hip replacement component. In vitro diagnostic medical devices include things like HIV blood tests, pregnancy tests, and blood sugar monitoring systems for diabetics.
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The new RPMD (Raflatac Permanent Medical Device) adhesive range includes labeling solutions for drug/ device combination products like insulin pens, auto-injectors, and inhalers, as well as blood donation labeling, sterilisation pouches for medical devices, and infusion bags and bottles. Combining selected paper and film face materials with an RPMD adhesive ensures excellent adhesion with a tight mandrel hold on glass and plastic, as well as sterilisation resistance and migration safety - both common requirements in medical device and healthcare labeling.
DIGITAL SPY
DIGITAL NEWS
talking
www.harmonicdrive.de
Trend setter: Why it’s time to take note of surgical robots
A
ACCORDING TO GRAHAM MACKRELL, HARMONIC DRIVE UK, SURGICAL ROBOTS ARE ONE OF THE WORLD’S FASTEST GROWING TRENDS
lthough the figure varies considerably between different market reports, most experts value the medical robots market between $2.67 billion and $4.2 billion as of 2014/15, according to research firms IndustryARC and MarketsandMarkets, respectively. The expected future growth is equally as staggering. With a compound annual growth rate (CAGR) of 22.2% per year, the market is expected to reach $11.4 billion by 2020.
POINT
So why the big push towards medical robots? Designed to improve a surgeon’s accuracy, comfort, dexterity and stamina, robot-assisted surgery has become popular for minimally invasive laparoscopic, orthopaedic and neurosurgery procedures that aim to reduce risks and improve recovery times. Such keyhole surgery relies on robots that can work through very small incisions, often alongside other instruments, quickly and accurately.
There are three main types of surgical robot: autonomous, dependent and shared-control. Medical professionals use robots for everything from surgery and rehabilitation, to non-invasive, general hospital and pharmacy applications. North America accounts for 62% share of the medical robots market, Europe for 24% of the market, with Asia Pacific and the rest of the world bringing up the rear.
Make it a date WHY MED IN IRELAND SHOULD BE ON YOUR MEDTECH RADAR
www.medinireland.ie
DIGITAL SPY
What is Med In Ireland?
Digital release READ ALL ABOUT IT: BIORESORBABLE POLYMER PUBLICATION www.smithersrapra.com
S
mithers Rapra Publishing has released a new book that focusses on biomedical applications of bioresorbable polymers. Bioresorbable Polymers and their Biomedical Applications looks at the application of bioresorbable polymers in the biomedical sector including their use as a replacement for metallic orthopaedic
devices due to their precise control of material composition and microstructure. It also looks at how they have been exploited by immobilising suturing thread with an analgesic or antibacterial drugs, and the development of bioresorbable vascular scaffolds, wound-healing and intravenous drug-delivery devices.
The event, which takes place on 19 October in Dublin, is a high-profile showcase for the entire spectrum of the Irish medical technologies sector. Medical devices, sub-supply, precision engineered components, diagnostics, connected health, healthcare providers, and research and development will exhibit to an international audience. Why Ireland? Ireland boasts one of the most successful clusters of healthcare technology in the global medtech community. The region’s medtech leaders will congregate at the RDS, Dublin, for Med In Ireland, organised by Enterprise Ireland (EI). According to EI, there are now 348 medtech firms based in Ireland, the majority of which are indigenous. The sector currently employs 29,000 people, with that figure forecast to rise over the next three years. Significant investment via the Science Foundation Ireland has boosted R&D the region, which is an academics’ paradise in terms of access to futuristic technologies. With such a large market share, it’s little wonder the world’s medtech leaders are heading to Ireland to conduct R&D, and step up their manufacturing game. The country sounds like it has its finger on the medtech pulse… Yep. Perhaps the biggest indicator of success for the Irish medtech sector is the recently unveiled Cúram Centre for Research in Medical Devices in Galway. Its aim is to unite collaborators to research and develop devices for treating chronic illnesses, including diabetes and heart disease. And with major names like Boston Scientific, Cook Medical and Stryker Instruments among its supporters, the centre seems bound to foster a wealth of new technologies.
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NEWS ANALYSIS
HOW FAR DO THE MEDICAL DEVICE RULES
I
affect health-related apps?
t is widely known that in some circumstances, software may fall within the category of medical device and so have to comply with the associated regulations as regards its Lorna Brazell and marketing. But deciding Piet Weinreich, exactly when software Osborne Clarke will be categorised as examine the issue such a device is not so straightforward. surrounding An Opinion from an software and when Advocate General of the it may or may not Court of Justice of the fall under medical European Union (CJEU) looks set to provide device regulations welcome clarity on this issue.
Background The Medical Devices Directive stipulates that in order to be a medical device, a software product must be intended by the manufacturer to be used specifically for diagnostic and/or therapeutic purposes in humans, but this definition comes in the middle of a longer and more complex definition of medical devices in general. This definition includes all products to be used for the “diagnosis, prevention, control, treatment or mitigation of a disease“. So it is not surprising that the CJEU has recently been asked to rule on the question, in a dispute arising in France.
Facts: the CICA software The software in question was a prescription support tool for healthcare professionals. It provides information as to contra-indications for various powerful drugs, such as anaesthetics, their dosage limits and the known drug interactions they were susceptible to. It analyses
patient-specific data prior to surgery and delivers real-time information to the anaesthetist during surgery, and can also be used in an intensive care setting to facilitate medical decision-makers to take the patient’s specific characteristics into account.
healthcare professionals take; they will not therefore be medical devices. However, any software which creates or changes medical information in order to help the healthcare professional use the information may fall within the classification of a medical device.
The question of whether or not it should be classified as a medical device arose because French national law required the software developer to obtain a national certification for the software. This, the software developer argued, was incompatible with the Medical Devices Directive’s objective of harmonising the regulatory landscape across the European Union. The French government, on the other hand, argued that because the software did not itself act on the human body it should not be classified as a medical device.
Conclusions
The Advocate General has now given his Opinion as to how the CJEU should respond to the French court’s questions. AG Sanchez-Bordona concluded that a prescription support tool, such as the one in this case, does indeed fall within the category of a medical device. He pointed out that it improves medical practice, in that it helps practitioners prescribe the drugs properly and avoid errors. It analyses patient data in order to calculate appropriate drug dosages. It therefore is instrumental in helping to prevent, control, treat or relieve illness. Such a tool can be distinguished from a general purpose software application being used in the healthcare context. Applications such as databases, or even email, may be used in healthcare, but will not be instrumental in the decisions
This Opinion looks likely to be followed by the CJEU when it eventually gives its ruling. It is consistent not only with the wording of the Directive but also the European Commission’s guidelines MEDDEV 2.1/6 on the qualification of autonomous software used in the health sector (although these guidelines do not lay down any absolute ‘bright lines’ as to what software will or will not qualify as a medical device). As the Advocate General noted, the guidelines of the competent authorities of various EU Member States also point to the same conclusion. In the circumstances, it would be surprising if the CJEU decided to follow the more restrictive analysis argued for by the French government. Although the consequence, if the CJEU does indeed accept this reasoning, is that a wide range of medical software will now be classified as a medical device and have to obtain CE marking before being placed on the market in the EU, manufacturers and developers will welcome the clarification of what has previously been a difficult set of provisions to interpret. It is far better to be certain of the regulatory regime which applies to a product, and ensure that it complies, than to be at risk of investigation and potential product recall if the belief that a product is not a medical device turns out to be unfounded.
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MICRO INJECTION MOLDING
NEWS FOCUS
Why there’s something to celebrate AT THIS YEAR’S FAKUMA
T
Fakuma takes place on 17-21 October in Friedrichshafen. As always the event offers plenty to excite any plastics processor
he Fakuma international trade fair for plastics processing celebrates its 25th birthday this year with a fully booked event. Previously unused floor space reserves will be occupied this year in order to cater for established and new exhibitors and to hopefully reduce the waiting list of hopeful aspirants. More than 915,000 square feet of overall exhibition floor space will be occupied this year by roughly 1700 exhibitors from 35 countries (including Germany) – and the proportion of manufacturers and distributors from outside of Germany has exceeded 35%, highlighting the international flavour of the show. The organiser of Fakuma believes that the reason why so many exhibitors return to the event – which is held in the technology region on Lake Constance where Germany, Austria and Switzerland meet – year after year can be explained by the fact that large segments of the plastics processing industry are changing – or are being forced to change – through the use of new materials, technologies and processes.
assembly and sterile packaging under cleanroom conditions, for technical medical component manufacture and assembly. Fakuma also includes first-class presentations held at the exhibitor forum which is booked out every year. Experts present new technologies, enhanced processes, product innovations and new solutions for improved economic efficiency in the production of plastic parts at the forum and will be available for an in-depth exchange of views. Fakuma is, says the organiser, the place where ‘plastics meet business’, and as the international trade fair for plastics processing, it is an ‘innovation engine’ for the plastics industry. Fakuma is the place where ‘plastics meet business’, the international trade fair for plastics processing
Industry 4.0 3D/4D printing technologies, as well as techniques and solutions for highly efficient processing of hybrid, composite and sandwich materials are examples. And a key feature of the event will of course be new machines, adapted moulds and mould standards, integrated quality assurance systems and controllable hydraulic/pneumo-hydraulic/electric drives, as well as network-compatible and communication-capable controllers plus software ie. Industry 4.0! Medical manufacture Plastics processing at Fakuma include injection moulding, extruding, thermoforming and 3D printing, as well as processing. Visitors will be able to see integrated module
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REGULATORY UPDATE
A
How to make a success of the Medical Device Regulation
fter much anticipation the new European Medical Device Regulation (MDR) was published in the Official Journal of the European Union on 5 May 2017. This new regulation replaces both the previous Medical Directive Proactivity and and the Active Implantable Medical Device due diligence are Directive (90/385/EEC). This new MDR is bringing the key to success a significant amount of changes to the medical device industry which means the time is now for for new MDR roll- manufacturers to sufficiently prepare.
out, says Peter Rose, Maetrics
The new MDR has been developed in order to provide a robust regulatory framework to the medical device industry which will ensure a high level of safety while helping to support innovation. It is important to note that the Regulation has binding legal force throughout the EU and enters into force simultaneously in all the Member States. The changes which this new Regulation will inevitably be very beneficial, however until the roll-out has been completed (by 2020) it is expected that there will be a few bumps in the road for medical device manufacturers.
The significant changes looming: Reclassification Certain products have received special consideration in the MDR and are subject to reclassification. These new provisions will apply to cosmetic implants, standalone software, products without an intended medical purpose, certain spine products and reusable Class 1 devices. Manufacturers should determine whether new conformity assessment routes are applicable to their product portfolio and then subsequently engage their notified body and take the necessary steps to make this change. Market access of legacy products For any new products to be placed on the market they will have
to be CE marked under the new Regulation 2017/745 after the transition period. This means that manufacturers need to be organised to ensure that all products that will be maintained on the EU market will be CE marked in accordance with the full requirements of the new MDR. Reprocessing of single use devices A slightly contentious issue throughout the MDR negotiations; the MDR now specifies that the reprocessing and further use of single-use devices should only take place where permitted by national law, while complying with requirements laid down in the Regulation. Technical documentation The new MDR is going to be much more prescriptive about the required content of technical documentation, particularly as there are more detailed requirements for Quality Management Systems. Manufacturers will have to ensure that they keep an eye out for the publication of new common specifications. Clinical Evaluation The new MDR will require more clinical evidence and clinical evaluation in proportion to the risk associated with a given device. It is advisable that manufacturers plan to review all their CERs if they havenâ&#x20AC;&#x2122;t already done so in the last 1-2 years and they must ensure that this data includes post market surveillance data. Vigilance and post market surveillance When conducting on-going assessments of potential safety risks, manufacturers will now be required to collect postmarket clinical data as part of their on-goingassessment of potential safety risks. It is also important to note that the reporting time frames have been reduced by half â&#x20AC;&#x201C; manufacturers will now have 15 days (compared to the original 30) to report serious incidents.
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REGULATORY UPDATE
Mandatory product liability insurance When it comes to liability, manufacturers must be able to show that they can provide sufficient funds for any potential liability. It is advisable that manufacturers seek legal counsel. Transparency A key theme in the new MDR and in order to conform with new transparency requirements, manufacturers will need to notify all products to EUDAMED (European Data Bank on Medical Devices). Labelling and supply change Every manufacturer will have to appoint a specific person who will assume responsibility for regulatory compliance (PRRC). Labelling requirements are much more prescriptive, this means that any information which is supplied by the manufacturer must be made available on the manufacturer’s website.
UDI Under the specifications of the new MDR, all devices will be required to be tracked through a Unique Device Identification (UDI) system, this means that manufacturers will need to properly plan for UDI implementation in the EU. The details about the EU UDI system are still under discussion however it is believed that it will not differ significantly from the newly established US system.
Notified bodies and their changing landscape It is no secret that over the last few years there have been quite a few safety issues, which means Notified Bodies (NBs) are coming under pressure from their Competent Authorities in order to increase scrutiny on the medical device manufacturers which fall under their remit. This means that NBs will themselves need to seek designation under the new MDR shortly after it is adopted. The problem is that NBs across Europe are already at capacity and it is expected that this will escalate. In fact there has been a significant decrease in the number of NBs who have been accredited to deal with medical devices regardless of the fact that the new MDR is increasing the workload of the NBs.
This means that there is going to be an immediate over demand from medical device manufacturers for NBs as they demand their services during this challenging transitional period. The new MDR states that once a NB is re-designated they will no longer be able to issue CE marks under the Directive – it is only in the manufacturer’s best interest to ensure that they agree on appropriate timescales.
Other important practicalities of implementation The harmonising standards and Delegating Acts that will make the MDR operational are still under active discussion and development at the EU level. It is important that manufacturers closely follow these developments by actively engaging with their trade associations, and where possible, lobbying to influence their final form. To complicate things even further manufacturers are going to have to phase in two transitions together as the medical device industry is currently having to transition to the newly revised ISO 13485:2016 standard required for medical device Quality Management Systems.
Steps for manufacturers There is going to be a substantial administrative burden placed on manufacturers, which means that costing’s for staffing and external requirements should be carefully considered and adjusted to ensure that regulatory compliance is met. It is essential for manufacturers and other economic operators to adopt a pragmatic approach to conformance. It is also highly recommended that a cross-functional project team be formed to manage this. In conclusion it is clear that manufacturers cannot under-estimate the time that will be required to implement the new MDR. A detailed plan with which is overseen by an assigned project manager will ensure roll-out is as seamless as possible. The challenge is that there are some underlying details of the MDR implementation process which are not fully defined yet. This means not only do manufacturers need to act now, but they need to take responsibility to watch the emerging regulatory landscape. A proactive approach to dealing with the changes will ensure the medical device market will be populated with high performing and safe devices.
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COVER STORY
Living proof:
Mouldmaking brings innovation to medical manufacture
T
he growth of the world’s population, increasing urbanisation, aging societies, growth of emerging market accessibility to healthcare service and increasing self-medication mean the demand for medical consumables continues to rise. As a result, the productivity requirements that must be met by manufacturers of medical consumables are also rising. Manufacturers are caught between the conflicting priorities of ever-increasing demands from customers in terms of quality and reliability, and the constant pressure to reduce costs. Manufacturers have limited production space, the costs of which is increasing. This has become an important factor in growth markets such as China and has created a demand for increased productivity per square metre of production space, coupled with higher demands in terms of production volumes and output. In recent years, medical manufacturers have countered this trend by increasing demand for compact solutions that yield higher productivity. At Schöttli, a Swiss mould manufacturer acquired by Husky Injection Molding Systems in 2013, those requirements are met with innovative designs such as compact side gate solutions and stack mould technology.
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the need for greater efficiency or profitability. Due to its compact size and sprue quality, a side-gating variant is generally used for the highcavitation injection moulds that are required to produce these components. Gating systems of this kind are now supplied by a variety of manufacturers. There is no such thing as an all-round, multi-purpose side-gating solution. In the past, a range of concepts were therefore developed and optimised for specific application areas or even for individual applications. Schöttli has also developed various side-gating systems to its range, enabling the mould manufacturer to cover many different medical applications with its own systems. Schöttli side-gating moulds use different drop concepts for each application. As a result, the number of drops varies between one and six for the production of injection cylinders, needle holders, needle holders for insulin pens, connection adapters, etc, depending on size, number of cavities and installation situation.
Integrated side-gate solutions meet the need for high quality
In the manufacture of injection pistons, there is generally no space for a two-arm or multi-arm star drop in the compact mould. Schöttli therefore offers a “hot edge” drop. This side-gating concept is designed for the specific mould concept and is more compact and therefore more suitable for applications such as injection pistons.
In the field of medical engineering, many components are required in increasingly large quantities, including syringe barrels, syringe plungers, IV set components, connection adapters, insulin pen components and more. There is also increased demand for higher productivity per square metre of production space and growing requirements on production volumes and output, as well as
According to customer requirements, injection moulds without side gating can also be equipped with a valve gate as a gating variant for a variety of medical applications, such as petri dishes. Valve gates are also particularly suited for a range of materials such as TPE or lowviscosity plastics. This allows for a particularly clean gate, but is not always possible for reasons of space.
Schöttli explains how clever mouldmaking solutions help meet the growing demands of medical manufacturers
One further application example that does not use side gating is needle protection caps that are directly injection moulded. In this case, compact drop holders with up to ten drops are used, ensuring excellent heat transfer. These side-gating concepts have their limitations, such as when more challenging plastic materials like PC, PA or PET are used. The processing temperature window for PA is very small, for example, and the total thermal capacity of PC and PET sets tight constraints.
Precision stack moulds double output With this gating technology, Schöttli’s compact mould design opens up potential to optimise and increase production. With the aim of increasing the output rate of a production unit and in addition to the use of multi-cavity moulds, the capacity of an injection moulding machine can be doubled by using stack moulds with two separating layers within a single mould. These systems, which use two mould parting surfaces within a single mould, achieve this with the same mould mounting surface and almost the same clamping force. As a result, production efficiency is greatly increased – at Schöttli, the proportion of stack moulds manufactured is now more than 30%. As with conventional moulds with very deep mould halves, the alignment of the individual mould segments in stack moulds is crucial to the quality of the injectionmoulded parts and the lifespan of the mould. At the commissioning stage, the manufacturer shows customers how they can align moulds to achieve an optimum production flow. The moulds include systems that support the customer, helping them to precisely configure and check the moulds, and to continually monitor the production process and make adjustments: monitoring
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systems with sensors, for example, helps ensure that mould halves are optimally aligned during the injection moulding process. The sensors record and evaluate data to detect possible deviations at an early stage.
Increasing electrification in the injection moulding process The trend towards electrification in the injection moulding process is noticeable in the medical market, with an increasing proportion of fully electrical machines. The use of electrical drive concepts is also increasing for moulds. Clearly defined pathways within moulds allow for quick, efficient and repeatable sequences. The a dv a n t a g es are clear — in the sensitive medical market, many systems operate in clean rooms where oil-free moulds contribute to a reliable, particle-free production process. Furthermore, electrical drives require less energy and can be integrated into existing control systems. Programmable control devices
COVER STORY
Left:
Speed star: Quick-change design for the threaded core which ensures that parts can be replaced simply and securely
Far left:
Stacking up: Schรถttli offers designs such as compact side gate solutions and stack mould technology
allow movements to be triggered independently and in parallel. Using the shortest possible reach and stroke distances within the moulds leads to a reduced cycle time. The possibility to limit the load and monitor torque reduces wear and tear and increases the service life of the mould.
Complex system with ease of maintenance Although you may consider stack moulds, unscrewing technology or sidegating technology as complex, it does not mean that manufacturers require a complex, demanding set of maintenance requirements. In applications involving complex cylindrical or conical connection pieces, such as a needle holder for an insulin pen, the pin protection system allows for reliable and accurate centering of the extremely thin core and optimises system reliability. As this solution also offers the ability to retract the entire core after the mould opening and to only move the core into the injection position field once clamping force has been built up, it prevents any risk of damage that might be caused by bending or even breakage. The benefit of making these cores, as well as drop-side threaded cores, accessible for simple handling and improved availability from the rear of the injection mould directly to the injection moulding machine, is made possible by the individual hot runner distributor design. Schรถttli hot runner systems are individually designed for specific applications.
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8464 Distrupol Advert - Medical Plastic News - Q1 2016-Final.indd 1
24/03/2016 09:33
Stuck on you
Adhesives COME OF AGE
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ADHESIVES
How slugs have inspired a medical-grade adhesive Lindsay Brownell, Wyss Institute, explains how medical-grade bio-glue inspired by slugs sticks to biological surfaces without toxicity
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nyone who has ever tried to put on a Band-Aid when their skin is damp knows that it can be frustrating. Wet skin isn’t the only challenge for medical adhesives the human body is full of blood, serum, and other fluids that complicate the repair of numerous internal injuries. Many of the adhesive products used today are toxic to cells, inflexible when they dry, and do not bind strongly to biological tissue. A team of researchers from the Wyss Institute for Biologically Inspired Engineering and the Harvard John A. Paulson School of Engineering and Applied Sciences (SEAS) has created a super-strong ‘tough adhesive’ that is biocompatible and binds to tissues with a strength comparable to the body’s own resilient cartilage, even when they’re wet. “The key feature of our material is the combination of a very strong adhesive force and the ability to transfer and dissipate stress, which have historically not been integrated into a single adhesive,” says author Dave Mooney, who is a founding core faculty member at the Wyss Institute and the Robert P Pinkas family professor of Bioengineering at SEAS. The research is reported in this week’s issue of Science. When first author Jianyu Li, started thinking about how to improve medical adhesives, he found a solution in an unlikely place – a slug. The Dusky Arion (Arion subfuscus), common in Europe and parts of the United States, secretes a special kind of mucus when threatened that glues it in place, making it difficult for a predator to pry it off its surface. This glue was previously determined to be composed of a tough matrix peppered with positively charged proteins, which inspired Li and his colleagues to create a double-layered hydrogel consisting of an alginate-polyacrylamide matrix supporting an adhesive layer that has positivelycharged polymers protruding from its surface. The polymers bond to biological tissues via three mechanisms – electrostatic attraction to negatively charged cell surfaces, covalent bonds between neighbouring atoms, and physical interpenetration – making the adhesive extremely strong. But the matrix layer is equally important, says Li: “Most prior material designs have focused only on the interface between the tissue and the adhesive. Our adhesive is able to dissipate energy through its matrix layer, which enables it to deform much more before it breaks.” The team’s design for the matrix layer includes calcium ions that are bound to the alginate hydrogel
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via ionic bonds. When stress is applied to the adhesive, those ‘sacrificial’ ionic bonds break first, allowing the matrix to absorb a large amount of energy before its structure becomes compromised. In experimental tests, more than three times the energy was needed to disrupt the tough adhesive’s bonding compared with other medical-grade adhesives and, when it did break, what failed was the hydrogel itself, not the bond between the adhesive and the tissue, demonstrating an unprecedented level of simultaneous high adhesion strength and matrix toughness. The researchers tested their adhesive on a variety of both dry and wet pig tissues including skin, cartilage, heart, artery, and liver, and found that it bound to all of them with significantly greater strength than other medical adhesives. The tough adhesive also maintained its stability and bonding when implanted into rats for two weeks, or when used to seal a hole in a pig heart that was mechanically inflated and deflated and then subjected to tens of thousands of cycles of stretching. Additionally, it caused no tissue damage or adhesions to surrounding tissues when applied to a liver haemorrhage in mice – sideeffects that were observed with both super glue and a commercial thrombin-based adhesive. Such a high-performance material has numerous potential applications in the medical field, either as a patch that can be cut to desired sizes and applied to tissue surfaces or as an injectable solution for deeper injuries. It can also be used to attach medical devices to their target structures, such as an actuator to support heart function. “This family of tough adhesives has wide-ranging applications,” says co-author Adam Celiz, who is now a lecturer at the department of bioengineering, Imperial College London. “We can make these adhesives out of biodegradable materials, so they decompose once they’ve served their purpose. We could even combine this technology with soft robotics to make sticky robots, or with pharmaceuticals to make a new vehicle for drug delivery.” “Nature has frequently already found elegant solutions to common problems; it’s a matter of knowing where to look and recognizing a good idea when you see one,” says Wyss founding director, Donald Ingber. “We are excited to see how this technology, inspired by a humble slug, might develop into a new technology for surgical repair and wound healing.”
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We are excited to see how this technology, inspired by a humble slug, might develop into a new technology for surgical repair and wound healing Donald Ingber
ADHESIVES
Additional contributors to this work include co-first author Jiawei Yang, Ph.D., Research Assistant at SEAS; Qing Yang, Ph.D., Associate Professor of Environmental Science and Engineering at Huazhong University of Science and Technology; Isaac Wamala, M.D., Research Fellow at Massachusetts General Hospital; William Whyte, Research Fellow at the Wyss Institute and SEAS; Bo Ri Seo, Ph.D., Postdoctoral Fellow at the Wyss Institute and SEAS; Nikolay V. Vasilyev, M.D., Assistant Professor of Surgery and Research Scientist at Boston Childrenâ&#x20AC;&#x2122;s Hospital; Joost J. Vlassak. Ph.D., Abbott and James Lawrence Professor of Materials Engineering at SEAS; and Zhigang Suo, Ph.D., Allen E. and Marilyn M. Puckett Professor of Mechanics and Materials at SEAS. This research was funded by the Wyss Institute at Harvard University, NSF, Materials Research Science & Engineering Centers at Harvard University, NIH, Science Foundation Ireland, Tsinghua University, as well as a Marie Curie International Outgoing Fellowship.
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Deepak Prakash, Thijs Janssens, Vancive Medical Technologies, and Paul Rosenstein, Pronat Medical, explain why material selection matters when it comes to skinworn wearables
let’s stick together M
edical wearables are intrinsic to digital health’s exciting future, but before a new skin-worn device hits the market, it must pass muster for biocompatibility, patient comfort and performance. Material suppliers and converters can help device makers through the material selection process. A digital healthcare revolution has started, and many across the medical ecosystem are engaged in it. This includes providers, patients, insurers, researchers, drug developers, materials suppliers, specialist converters, and, of course, medical device manufacturers. There also are many participants from outside the realm of the traditional medical establishment. These include cloud technology providers, software and app developers, battery and sensor specialists, mobile device makers and many others. Wearable medical devices will play an important role in digital health’s evolution. They enable remote monitoring and anytime-anywhere care delivery, both associated with cost savings, convenience and, in some cases, better patient compliance with treatment plans. This ultimately can lead to more positive outcomes and higher-quality care. Skin-worn wearable devices offer a discreet way to gather vital signs or track physiologic metrics over extended time periods of one to two weeks, or even longer. These ‘smart patches’ also can be used for shorter tests and transdermal drug therapies. As device makers race to bring new products to market, they can benefit from putting an early emphasis on material selection. Alliances with advanced materials suppliers and medical specialist converters can help this process move along smoothly. Ideally, device developers should forge partnerships with medical materials providers and converters well before they lock in specifications and file for regulatory approvals. That way, the partners can work together to evaluate the wearable project’s parameters and collaborate from the beginning on material selection. This approach reduces the likelihood that the device maker will need to switch out one material for another later in the game, which can cause significant delays. First, a few basics Navigating through wearable device material selection may seem like threading your way through a labyrinth of formulations, chemistries, constructions and regulations. To demystify the process a bit, it can be helpful to have a basic understanding of the adhesive materials that serve as wearables’ building blocks. While there are many variables to consider in selecting the right adhesive materials, there are two overarching classifications that provide a helpful framework for the decision-making process. 1. Adhesive purpose. At a high level, there are two primary types of adhesive materials used in skin-worn devices — the kind that hold the device to the patient and the kind that hold elements of the device together. The former are called skin-contact layer adhesive latter are known as construction, or tie-layer, materials. 2. Adhesive fluid handling method: The second big-picture factor to consider is how the adhesive material will manage bodily fluids such as sweat. For wearables requiring extended wear times, moisture management is probably the single most important material performance characteristic. It affects both functionality and patient comfort, which ultimately drive whether the device will be worn as intended and prescribed. There are two primary forms of moisture management:
Supporting role: Vancive says that skin-worn wearable devices will support the rollout of digital health initiatives but must be comfortable, safe, easy to use and reliable
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ADHESIVES
• Moisture-vapour transmission: Tiny holes in the adhesive material allow moisture to move from the skin and out through the material to evaporate. Materials leveraging this approach are referred to as breathable. • Fluid absorption: The material absorbs moisture, holding it away from the skin so that it doesn’t cause irritation or clamminess. The material contains ingredients that wick away the majority of the exudate (fluids), forming a gel within the material’s structure.
medical materials providers and specialist converters also will have extensive clean room and sterilisation capabilities. Only when all of these pieces come together, complete with end-to-end best practices and process controls, can the wearable device maker rest assured that the final product will be free from contamination and contain only safe components. Industrial design and a medical device mindset
Throughout the wearable material selection process, it’s essential to evaluate the interplay between these core factors. Some skin-contact layer adhesives make excellent bedfellows for some constructionlayer materials, and others are incompatible. Their compatibility often is directly related to their moisture management method. For example, if a device maker wishes to use a breathable skin-contact adhesive, the manufacturer also should be sure to use a porous constructionlayer material or to include air channels in the design. Otherwise, fluids will be trapped and unable to evacuate and evaporate properly.
The digital health market, and wearables as a high-growth category within it, have both benefited from multidisciplinary participation in an exciting wave of product development and commercialization. Never before has the healthcare industry witnessed this level of involvement from entrepreneurs, scientists, venture capitalists and technologists from all walks of life. The resulting innovations blend diverse expertise, from consumer electronics to pharmaceuticals to social media. The best wearable product development teams leverage this eclectic mix of talent to think outside the box.
When vapour transmission is the preferred fluid handling approach, acrylic adhesive materials are a popular choice for the skin-contact layer. Acrylic adhesives can be coated onto thin foams or soft nonwoven carrier materials. They are very stable, with few residual components that could leech into the skin over extended wear times. For the tie layer, there are breathable transfer (or free film) tapes as well as some new double-coated tapes that provide reliable fixation for device components while complementing the breathability of the skin-contact layer.
But for skin-worn wearables, it’s also important to be sure an industrial designer has a medical device mindset, including strong anatomical knowledge. When such an industrial designer is guiding development, and working closely with an experienced medical material supplier and specialist converter, a wearable device project can avoid some pitfalls and setbacks. As just a few examples, the industrial designer will anticipate and address concerns such as:
Some wearable device designs simply do not allow for moisture vapour transfer. Perhaps there is an airtight rigid plastic casing required to protect the device’s sensors and battery. Or in other situations, the target patient population may have extremely fragile or damaged skin, prompting the use of a gentle, silicone-based adhesive gel or an absorbent hydrocolloid. In some cases, if a non-breathable device structure has to be used, a specialist converter can perforate certain materials to generate some breathability. When there is no means of ventilation, another solution is to position an absorbent hydrocolloid skin-contact material layer as an island beneath the sensor housing to capture moisture and keep tissue comfortable.
• Why different adhesive materials are needed to fixate devices to body areas with highly flexible skin vs. flat, tight skin
Biocompatibility across the value chain On the material selection journey, device manufacturers need partners who can pave the way to wearables with unquestionable biocompatibility and safety. For example, a medical specialist converter will supply comprehensive documentation regarding how all device materials meet ISO 10993 standards. This is often demonstrated through biocompatibility reports documenting the material supplier’s test results for cytotoxicity, skin irritation and sensitisation according to these standards. Wearable device developers should expect nothing less.
• How smart patch body placement relates to sensors’ ability to pick up the clearest signals
• How sweat levels and bodily secretions vary by body part • Why medication regimens for certain chronic diseases can cause skin to be very fragile • How device removal must be atraumatic, especially for pediatric patients It is also important to note that up to 10% of the general population are likely to react badly to skin-worn adhesives, especially acrylic adhesives. This is a reality that needs to be borne in mind during clinical trials and wear tests. In conclusion, skin-worn wearable devices will continue to support the rollout of revolutionary digital health initiatives. With patient care on the line, they must be comfortable, safe, easy to use and reliable. It’s important to devote attention to materials selection very early in the device development process. With collaborative partners from advanced materials and medical converting, wearable device makers can stay ahead of the curve in performance, biocompatibility and patient experience.
Yet safety and optimal device performance ultimately depend on much more than biological evaluation of the material chemistries. The focus on biocompatibility and quality must extend well into the value chain. Suppliers’ facilities should be ISO 13485 certified, which means their operation’s quality management systems meet strict standards for the design and manufacture of medical devices. Top
Cutting edge: Complex rotary cutting and laminating in Pronat’s cleanroom
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adhesive than a significantly smaller monitoring device for guiding back therapy.
ADHESIVES
Marie Crane, Dow Food, Pharma & Medical, explains how silicone adhesives for wearable medical devices promote compliance and innovation
Forming an attachment The global wearable medical device market in 2016 was valued at just over $13.2 billion, according to Kalorama Information, a market research firm. By 2024, it is projected to reach $612 billion, as noted in a 2016 report by Grand View Research.1 Fueling this expected growth are mega-trends, which continue to drive the development and broader adoption of wearable devices for diagnosis, monitoring and treatment. These trends include increased prevalence of chronic diseases requiring ongoing monitoring; greater use of home-based and outpatient care for cost control; and technology advances such as miniaturisation, wireless innovations, wearable biosensors and 3D printing. Unfortunately, because many wearable medical devices are used at home, instead of in a supervised inpatient or long-term care setting, some patients may fail to use them correctly or consistently. Patient behaviour directly affects the device’s efficacy, calling for solutions that can promote compliant usage. One important approach to optimise patient compliance is to ensure that skin-adhered devices are comfortable and non-irritating – both while wearing and when removing the device. Another way is to give patients the ability to use the device when taking part in everyday activities, such as showering, sports and recreation. In both cases, choosing the right type of adhesive for a skin-adhered medical device can encourage patient compliance, which in turn improves efficacy and outcomes.
Duration of use: A device designed for short-term wear, such as a fetal monitor, can use an adhesive with high tack and lower peel adhesion, so it adheres to the skin with light pressure and can be removed with a low peel force. These properties ensure gentle removal to minimise discomfort for the patient. On the other hand, wearable devices for extended use – such as ostomy bags and longterm ambulatory monitoring mechanisms – require strong and stable adhesion and high shear strength, while maintaining patient comfort. Water repellency is important for longer-term use as well, as it allows the patient to bathe, shower or perspire without risking adhesive separation. Permeability to oxygen and moisture helps keep the underlying skin in good condition over time.
Why silicone adhesives? First, medical-grade silicones are biocompatible and have delivered proven performance in medical device applications for 70 years. Medical silicone adhesives offer key advantages that make them distinctively appropriate for wearable devices. They are non-cytotoxic, nonirritating and non-sensitising to skin. Silicones also spread easily to form films over the skin. Because silicones are hydrophobic, a skin-adhered device could potentially be worn in the shower or for sports activities, helping to encourage consistent usage by the patient. They are also several hundred times more breathable than
any other organic polymer, which enhances comfort. These materials also conform well to body contours for improved fit and comfort. Silicone technology gives medical device designers a great deal of flexibility. Key properties such as adhesion level, conformity to the skin, peel strength and permeability – as well as transparency and even processing parameters – can be customized to meet specific requirements.
How do silicone adhesives stack up against acrylics and polyurethanes? • Acrylic adhesives are widely used because of their cost advantages. They provide a very strong, secure bond with the skin, making them a good choice for long-term device use. Most release cleanly off substrate surfaces without leaving a residue. However, they cannot be repositioned, and removal can cause pain and skin trauma in the elderly or young children. • Polyurethanes deliver medium adhesion. Cost-wise, they are more expensive than acrylics, but less expensive than silicones. Because they are more hydrophilic than silicones, polyurethanes also provide better exudate management. However, moisture absorption can lead to a reduction in skin adhesion. Also, these adhesives have very low breathability compared to silicones, and they tend to leave a residue when removed.
Which silicone adhesive? The two main sub-categories of silicone temporary skin adhesive are pressure-sensitive adhesives
Adhesive considerations Designers of wearable devices should consider these variables when selecting an adhesive: Skin type and condition: The patient’s age and health are essential to determining the best adhesive for a wearable device. Elderly people can have thinner, less-elastic skin that can be susceptible to tearing or become damaged during removal or repositioning of the device. Alternatively, infants and young children tend to have delicate skin that can be sensitive and easily irritated. People with skin diseases or conditions are also at risk for damage from the wrong adhesive. A gentle, non-sensitising adhesive with low peel force can help to protect skin integrity in these situations. Making matters even more complex, skin sensitivity, hair coverage and thickness and movement can vary by location on the body, so it’s important to consider where the device will be worn. Device size and weight: While device miniaturisation is a major trend, some wearables must accommodate additional functionalities and therapies that expand their dimensions and weight. Larger and heavier medical devices require a different adhesive technology than miniaturized devices. A good example would be an external prosthesis which might call for a stronger 26
Flexible friend: Silicone technology gives medical device designers a great deal of flexibility
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(PSAs) and soft skin adhesives (SSAs). Although both are applied using pressure, PSAs generally offer stronger adhesion than SSAs, making them suitable for devices that are worn longer or are larger and heavier – by up to several grams. Typical PSA properties include high shear strength and strong, stable adhesion for up to two weeks. They can be used in devices such as external catheters and sheaths.
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SSAs exhibit significantly lower peel adhesion than acrylic and polyurethane. This property makes them suitable for devices worn by patients with compromised or delicate skin. Growth in longer-duration wearable medical devices, such as wireless monitors, created a need for strong, durable adhesives that are gentle on sensitive skin – in effect, a middle ground between PSAs and traditional SSAs.
Flexible friend: Silicone technology gives medical device designers a great deal of flexibility
To meet that need, Dow Corning, developed Dow Corning MG 7-1010 Soft Skin Adhesive, a two-part, low-viscosity product that delivers the highest adhesion in the company’s SSA family. Applications include insulin pumps and glucose, fetal and cardiac monitors.
Expanding the scope of wearables Although diagnosis and monitoring continue to lead treatment as the most popular applications for wearable devices, manufacturers are adding therapeutic functionality to some of these products, in part because treatment devices command a higher price. For instance, a glucose monitoring device worn on the body may include a pump to inject insulin automatically, so the patient does not have to self-administer the drug. Taking this concept even further, microneedle patches could replace administration of insulin and other drugs using syringes.2 Other examples include smoking cessation devices that not only communicate with the smoker’s smartphone and transmit information to the device maker to track compliance, but also use transdermal patches to deliver nicotine at specific times of the day when smokers are
Sticking point: It’s important to ensure that skinadhered devices are comfortable and non-irritating
likely to crave a cigarette. As the role of skin-adhered devices expands and diversifies, the need for nextgeneration adhesive solutions will only increase. Silicone adhesives offer unmatched design freedom, a long history of safety and biocompatibility, and desirable performance attributes – such as gentle removal and non-sensitisation/irritation. Silicone technology supports new innovations in wearables and promotes positive outcomes through improved patient compliance. 1 Connected Health And Wellness Devices Market Analysis By Type (Healthcare IT, Health Information Exchange, Healthcare Analytics) By Product (Personal Medical Devices, Insulin Pump, BP Monitor, Portable GPS PERS, Glucose Monitor, Personal Pulse Oximeter, Digital Pedometer, GPS Sports Watch, Heart Rate Monitor, Sleep Quality Monitor, Software & Services, Online Subscription, Fitness & Wellness App, Meal Plan, Coaching Services) By End-Use And Segment Forecasts To 2024. Grand View Research. August 2016. http://www.grandviewresearch. com/industry-analysis/connected-health-wellness-devicesmarket 2 Smart patch: the wearable insulin needle. October 30, 2015. http://www.medicaldevice-developments.com/features/ featuresmart-patch-the-wearable-insulin-needle-4786818/
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Sticking to skin presents a major challenge to the medical device industry
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ADHESIVES
Is this the adhesive medical device manufacturers have been waiting for? 3M reveals its latest adhesive and why medical device manufacturers might be interested in its development
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ccording to a market by MarketsandMarkets, the medical adhesives tapes market is projected to grow from an estimated $6.64 billion to $8.76 billion in 2022.
Finding inspiration from a range of sources – geckos, sandcastle worms and slugs, the sector’s aim to find increasingly better and more effective medical adhesives, continues. One company that has been looking at this is 3M, inspired by a patient’s heart monitor that kept falling off. The company makes everything from Post-it notes to structural adhesives that hold airplanes together. It also makes advanced medical adhesives that can hold for up to two weeks. When considering adhesive science and the challenges of a substrate like skin, design engineers know sticking-toskin is trickier than you would think. However, the company believes that the addition of 4076 Extended Wear Medical Tape to its portfolio, 3M’s Medical Materials and Technologies business has given medical device manufacturers and engineers a long-term wear, acrylic-based adhesive solution designed to increase patient comfort and provide a strong and reliable bond in challenging applications. According to 3M, this non-sensitising, conformable adhesive was developed for long-term wear, providing a bond that is firm yet comfortable so patients may not even realize they are wearing a device. This allows engineers and manufacturers to focus solely on their device’s design and application, spurring innovation while ensuring their timeline and budget requirements are met. “Sticking to skin presents a major challenge to the medical device industry,” said Diana Eitzman, director of agile commercialisation, 3M Critical and Chronic Care Solutions Division. “By equipping our customers with the latest adhesive technology, we’re giving them the power to solve their toughest design challenges and positively impact patients’ lives globally.” Compliant with ISO:10993 and ISO:10993-10, medical industry regulations assessing a product’s potential to produce irritation and skin sensitization, 4076 Extended Wear Medical Tape is approved for use on intact skin.
Finding inspiration from a range of sources – geckos, sandcastle worms and slugs, the sector’s aim to find increasingly better and more effective medical adhesives, continues
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EMERGING MARKETS
For many of us, digital health emerged a few years ago, but there are new opportunities on the horizon that are about to make a big difference to the market – and medical device manufacturers are first in line to benefit, says Lu Rahman
W
hen I plan emerging markets pieces I’m usually thinking along the lines of geography. Which corners of the globe are ripe for new business and where can the latest opportunities to be found? In this line of work it’s our job to keep on top of new trends. We’re constantly looking ahead to see what’s going to be big this time next year. For that reason, what I’m going to write about probably isn’t an emerging trend for many (especially me given the launch of Digital Health Age in 2015) but it’s a trend that’s gaining ground rapidly and has renewed potential for the medical device sector. Of course, I’m talking about digital health. Nothing that new is it? We’ve been reading about digital healthtech for years now. We now that connected devices exist, we’ve heard all about health apps and whether or not they’re actually medical devices, and we’re well aware that increasing numbers of hospitals on a global scale are looking at ways of improving care using digital
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products. So yes, while it’s true that digital is nothing new, there was something that happened this week in the UK that could prove to be a real game-changer for any company supplying UK medical device companies or manufacturing devices for that market. A few days before this issue of MPN went to press, I visited the Health & Care Innovation Expo in Manchester. Very much focussed on the UK healthcare system and its staff, the expo brings together thought leaders, patients, and businesses trying to reach that market as well as providing a forum offering the opportunity to hear about the latest pathways and technology the NHS is implementing. Having attended the event three years in a row now, this one stood out in its heavy focus on technology – digital technology. If there was one key message coming out of the Health and Care Innovation Expo 2017, it was that the future’s digital. Am I surprised? Not at all. I’ve been flying the
flag for digital health for years. But this technology is now becoming the norm and importantly, the public both expects and embraces these products in its daily life. The expo exhibition hall was filled with heathtech companies and the digital health zone was packed to the gills. Companies including Amazon, Google Could, Now Heathcare and Teva had a clear and strong presence at the event highlighting the sector’s ability to pull in technological heavyweights – not bad for a show that’s only been running since 2014. It’s a big thumbs up to the businesses that have been pushing back the boundaries of healthcare, the early adopters of the tech and of course the NHS which has implemented programmes to ensure that roll-out and access to digital technology is on-track and successful for both clinicians and patients.
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EMERGING MARKETS
As wearable devices become more widely used, the need for high quality design skills will be required – one device won’t fit all after all
And more than this, UK health secretary Jeremy Hunt revealed a range of measures to digitise the NHS. With initial plans including electronic health records and an app to facilitate easy access for patients, the next step will of course be a movement to increase digital devices and tech within the NHS estate. So where does all this fit with the medical device manufacturer or supplier? Connected devices are so much more than linking a machine to a wifi network. We’re talking about medical devices with accompanying apps, that may need to be manufactured using the latest in antimicrobial technology and that incorporate the best in cyber-security software. As wearable devices become more widely used, the need for high quality design skills will be required – one device won’t fit all after all – and of course, software developers will come into their own. Other sectors such as micro-manufacture and sensor technology should also see significant opportunity as the uptake of connected technology increases. The medical adhesives market is already feeling the effects of this industry – read the Vancive artice on page 24 top get a feel for how this business is addressing the needs of the ‘digital healthcare revolution’ as it puts it. Earlier this year Accutronics exhibited its ‘smart battery’ at the Med-Tech Innovation Expo in Coventry, designed for wearable devices. The company recognised the shift for more compact battery sizes as devices sizes shrink. The list goes on…
Over the last few weeks alone we’ve run stories on devices that track metrics. We all know about the Apple Watch and we’ve heard about the company partnering with medical device maker Dexcom to link a glucose monitoring device with the Apple Watch. News on the Series 3 watch reached us recently – the device features a new operating system which includes an updated heart rate app that measures users’ heart rate when resting and recovering, during workouts, walking and breathe sessions. The device can also be set to send out a notification when a person’s heart rate is elevated above a specific level. Does this have medical use potential? Most definately. In a similar vein Samsung broke news of its Gear range of products that track fitness levels. We also have products very clearly aimed at the connected remote market. Take InsulCheck Connect. This is a snap-on accessory for disposable insulin pen users, that automatically collects and records pen usage and behaviour data on the go. It’s just one example of devices being designed specifically for the digital healthcare sector. While digital health isn’t brand new, and for many it was an emerging market a few years ago, there are undeniably new and increased opportunities to be had and thanks to UK healthcare policy we are likely to see a fresh wave of demand emerge. Medical device manufacturers and suppliers are in the ideal position to take advantage of this to create healthtech products that fit the requirements of an increasingly connected healthcare system for future generations.
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MATERIALS
MATTER OF SUBSTANCE
H
ealthcare application providers are torn in two directions when it comes to working with new materials. On the one hand, they would like to build superior devices to existing ones – or all new applications that cannot be realised with existing materials. On the other hand, every new material requires lengthy approval processes. As a result, new materials should provide a significant new value proposition to justify the investment in new applications and devices. Two main factors drive the value proposition of a new material in the healthcare industry. The first factor is related to the actual physical and chemical properties of the new material. These properties decide if a product is capable of serving a defined purpose. Details are listed in technical data sheets. For styrenic materials, for example, the data sheet may contain dozens of mechanical, thermal, rheological and other properties. An important material property for many materials in the medical industry is the chemical resistance against drug media. Residual monomer and additive release into the media needs to be kept to a minimum, and low adsorption and absorption of targeted drugs are very important drivers when selecting new materials. Styrenic materials traditionally show a very good performance in this area and Styrolux, an Ineos Styrolution SBC material, excels with a strong resistance against drug media. In addition to the material properties, application providers also pay attention to the ease-of-use of working with a certain material. ‘Ease-of-use’ describes a long list of criteria that may be different from material to material and from application provider to application provider. The list ranges from processability of the material all the way to services provided by the material provider. It includes topics like product quality, availability of the material (eg. long-
term availability and early notification of change, reliable deliveries), logistical aspects and many more criteria. Global application providers may have additional requirements such as sourcing across different regions at identical quality. In this article, we look at two examples of new materials responding to healthcare application providers’ needs. The first project has been completed only recently. It is a perfect example of providing a solution to the industry that meets expectations – and is adopted almost instantly. The second example discusses a future scenario of a certain application.
Fibre filled ABS Earlier this year, INEOS Styrolution brought a new ABS material to market that was the first of its kind (see also reference 1): A glass fibre-filled styrenic ABS (acrylonitrile butadiene styrene) grade, especially for medical applications. The new material, called Novodur HD M203FC G3, does impress with its mechanical properties such as stiffness, impact strength and dimensional stability, its high flowability (melt volume rate, 220 °C/10 kg, ISO 1133: 18cm3/10 min) allowing for an excellent processability – and, last but not least, the fact that it is compliant to regulatory standards in the healthcare industry. Novodur HD M203FC G3 meets the requirements of European and Japanese pharmacopoeia and it has been
New for old: Image 1 Spike (Fleima). According to Ineo Styrolution healthcare application providers are torn in two directions when it comes to working with new materials 32
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Alexander Silvestre, Norbert Niessner, Michiel Verswyvel, Bernd Elbert and Cliff Pettey, Ineos Styrolution, examine styrenic solutions for the medical device sector
MATERIALS
tested according to the USP Class Biological Reactivity Tests Class VI and relevant 10993 standards.
• easily bonded to other materials
This new material was immediately embraced by the industry and a first application became available only briefly after the material was introduced (see image 1 and reference 2).
• excellent flowability and processability
While the material properties alone were convincing already, the regulatory approval and the fact that the material is offered with Ineos Styrolution’s signature “Full Service HD Package” (which includes an up to 36 months notification of change) contributes to the material’s attractiveness and reduced risk for application providers.
• limited to no pre-drying
All-styrenic IV set Healthcare application providers constantly look for alternatives for commonly used materials. Having alternative solutions at hand does not only allow exploring new properties or new functionalities. They also provide a safety net if tighter regulations demand shifts towards new solutions. Ineos Styrolution has proven that styrenics make ideal materials for a range of healthcare applications – and the company is constantly growing the number of dedicated solutions for the healthcare sector. Today, Ineos Styrolution is aiming at developing the first allstyrenics IV set. Being a dedicated supplier for styrenic polymers in the healthcare industry, the company is bundling its styrenics IV activities within its global healthcare team, led by Alexander Silvestre. Styrenics provide several properties resulting in a higher efficiency and lower cycle times. These may be key for an application provider. The key benefits of styrenics include
• a low density resulting in more output • high flow grades • lower processing temperatures Styrenics provide the additional benefit of clean incineration after use. Overall, it can be said that the Ineos Styrolution materials such as Styrolux and Styroflex show properties that are well balanced making them ideal solutions for IV sets. In addition to the above list of properties, the materials show an excellent behaviour in drug absorption tests, in particular in comparison to traditionally used materials. This includes, for example, a very low absorption rate for insulin and overall low absorption values for typical drug molecules. Ineos Styrolution has a strong presence in this field, with solutions such as • MABS (Terlux), SMMA (NAS) and MBS (Zylar), highly transparent materials for connectors • dedicated Styrolux grades, specifically designed for the use in drip chambers in IV sets • the above mentioned Novodur HD M203FC G3 for demanding applications like spikes and applications requiring structural stability • Polystyrene and ABS solutions for roller clamps
In addition to these existing materials, Ineos Styrolution is currently working on material solutions for the flexible parts of the IV set. • Materials for tubing are under development using SBC (styrene-butadiene block copolymer) based solutions (see references 3 and 4). Important properties for good tubing materials include a high transparency for visual inspection, good resistance against kinking during bending to ensure continuous drug feeding and good resilience. The recent integration of the K-Resin business into Ineos Styrolution’s market leading styrenic portfolio leverages both companies’ respective strong technical heritages to create new and innovative customer solutions for medical applications. • Materials for IV bags require film featuring a good puncture resistance, good transparency and they must be able to be sterilised. The materials also need to feature a defined shelf life, which is due to high barrier properties. Another aspect is the need for regulatory approved stabilisation and additive (eg. waxes) packages. First developments have been reported (see reference 5). Ongoing research show that it is crucial to combine puncture resistance with high temperature resistance and certain barrier properties (provided by polyolefins and cycloolefins). Norbert Niessner, global head of research and development/ intellectual property at Ineos Styrolution, summarises the ongoing efforts. “Our development team is closely linked not only to state-of-the-art technology to develop and produce innovative styrenics based materials, we are also in close contact with leading medical OEMs, thanks to the global presence of our healthcare team. They constantly provide us with valuable insights into the industry’s needs.”
REFERENCES: 1. INEOS Styrolution press release, dated February 1, 2017 2. INEOS Styrolution press release, dated February 23, 2017 3. WO 1996024634 A1 (Norbert Niessner, Jens-Otto Kathmann, Konrad Knoll, Paul Naegele, Hans-Michael Walter; BASF AG) 4. Flexible Tubing Developments with K-Resin SBC Resins”; Medical Tubing Conference Woburn, MA (USA) 2016 (Joe Zhou, Cliff Pettey; CPChem) 5. US 8852748 B2 (Ashish M. Sukhadia, Max P. McDaniel, Ted Cymbaluk, Rajendra K. Krishnaswamy, Lawrence Szmutko, CPChem)
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MICROMOULDING
It’s a small world Cikautxo Medical explains why silicone parts are moving to micro manufacturing
T
he continuous growth of minimally invasive surgical procedures, the increasing demand of high precision medical devices and the latest advanced manufacturing technological developments are leading towards a new trend of small and precise silicone components manufactured under new micro-techniques that conventional injection moulding processes are unable to achieve.
Micro injection moulded parts
Machinery management: for medical applications fully electrical liquid silicone (LSR) injection moulding machines are preferred for high volume manufacturing scenarios in a cleanroom environment. Special emphasis has to be made in using a very precise dosing system. On top of it, in order to maintain the microinjected component within the strict tolerance limits, it is key to monitor the capability process index (Cmk) to achieve a good dimensional capability process index (Cpk) Only high skilled and selected technicians are capable of defining and setting up the LSR injection moulding processes using parametrical profiles for a proper cavity load and control over the production run. Those parametrical profiles are created matching the best injection parameter combinations and defining an area where the parts produced meet the quality requirements. Any injection cycle outside this area will lead to an automatic refusal of the cycle so that the quality can be automatically assured. TOOL CONCEPTION
The new micro injection technologies allow the precise manufacturing of silicone parts weighing only a few milligrams (a range of 10 milligrams is generally used to define the border), components with strict tolerances (for example for high precision valves) and for conventional injected parts having some particular or critical micro structured zones (for example thin section membranes) Silicone micromoulded components are increasingly used in minimally invasive surgical devices, in small and precise fluid control activities (valves, septums and seals), in devices fitted with microsensors, in precision overmoulding operations and in many components in general designed with challenging geometries or with high precision requirements.
Silicone micro-moulded components are manufactured with flashless concept. This statement implies a high precision tool conception combined with a cold runner technology and a needle valve gate system where dossing precision becomes crucial. A high volume mass production project requires a high number of cavities tool, normally 32 or 64. In those cases, each tool needs to be perfectly machined and correctly balanced, making the set up and complexity of the mold growing at an exponential level. EXTRACTION AND PROCESS CONTROL Micromoulded parts have to be extracted from the tool and handled fully automatically due to its extremely low dimensions. This implies robotic arms, vacuum systems and integrated quality controls, normally artificial vision systems. FINAL QUALITY CONTROL Slicone micromoulded parts in high production outputs are ideal for a big data quality management method, where statistics of all production parameters can be used for predictive maintenance actions.
Silicone micro injection components: manufacturing techniques “In Cikautxo Medical, for a high quality mass production manufacturing of technically complex silicone micro injected components, we pay special attention to the following manufacturing key aspects” says Iker Principe, CEO in Cikautxo Medical, the medical division of Cikautxo Group. Raw materials
Extremely accurate silicone parameters with repetitive formulations and stability over the time and over different batches are required from advanced liquid silicone suppliers to minimise potential variations in the part manufacturing process. Incoming inspections and testing are regularly made to raw materials by silicone experts in Cikautxo’s internal Cikatek laboratory.
AREA
CRITICAL ASPECTS IN LSR MICROMOULDING
Machinery Management
Dosage precision, appropriate Cpk and Cmk, parametrical profiles.
Tool Conception
Flashless, high precision, accurate set up
Extraction & Control
Fully automatic, integrated control systems
Quality Control
Big data
“As a resume, LSR micromoulded components require specific machinery, highly skilled operators, high precision tooling, full automation along the whole process and an efficient automated control. In addition, a holistic approach across all the added value chain is well recommended during the engineering, simulation, prototyping and validation stages. Finally, a very solid expertise in high quality mass production of silicone injection moulding components is required in order to guarantee the highly demanding level of precision and quality that those components require”, says Principe.
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BIOPLASICS
Organic and biodegradable, bioplastics can be used in a range of biomedical applications. Pyam Ramnes explains
F
amiliar to most people, plastics are fossil-based and suffer biodegradability. Bioplastics, however, are organic-based and biodegradable. These kind-to-the-environment materials are from resources like plants and animals which are far more sustainable resources than the fossil-based resources like oil and gas. As a result, the biodegradability of bioplastics combined with the sustainability of their resources, make them a great candidate in the medical field. Whether for artificial eyes or modern implants, several materials have been used in the medical field. But, a material that benignly disappears in the body would be a panacea. With the emergence of biodegradable and bio-absorbable polymers, temporary prostheses, tissue engineering, and drug delivery vehicles began to rise. Tissue engineering is a technology that solves donation and transplant rejection problems. It improves tissue function. Biomedically, a malfunctioning or damaged organ may be treated by growing its own cells. This treatment requires a physical support, which is known as scaffold, to guide the formation of new cells. The scaffold role is to facilitate the adhesion of cells and promote the growth of cells. As a result, the scaffold has to degrade as the new cells are grown and formed. Then, the degraded material can be metabolised by the human body. Auspiciously, poly-lactones such as poly-lactic acid (PLA), polyglycolic acid (PGA), and poly-caprolactone (PCL) are bio-absorbable, biodegradable and biocompatible. Among the poly-lactones, polylactic acid (PLA) is the most desired one for the medical applications due its mechanical properties. PLA is made from lactic acid, which is an organic acid and can be produced from fermentation of sugars which is a sustainable process. This production method is highly desirable by yielding high quality, low cost, and low energy consumption. The fermentation required carbon which can be derived from pure sugar such as glucose, sucrose, or lactose. The carbon source of bacterial fermentation can also be obtained from molasses, whey, sugarcane bagasse, cassava bagasse, starchy materials (potato, tapioca, wheat and barley), or any other material that contains sugar.
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FRIEND The process of polymerisation of lactic acid is shown in the below figure: PLA can b e
processed in many ways from injection moulding to extrusion and 3D printing. Additionally, it can be processed by spinning film and casting. PLA melting temperature ranges from 180°C to 220°C which is considered a low melting temperature when it is compared to other plastics. Engineering the scaffold lays out the structure of scaffold with the means of architecture, porosity, pore size and distribution, and interconnectivity. This structure needs to be engineered with respect to the cells growth rate, colonisation rate, nutrient delivery, and waste removal. Also, the scaffold can be engineered to emulate
specific mechanical and material properties of the tissue of interest. Ideally, the engineering of the scaffold should aim for the facilitation of the attachment, migration, proliferation, differentiation, and 3D spatial organisation of the cell population required for structural and functional replacement of the target organ or tissue. Currently, the optimal scaffold design is based on the absorbability of the scaffold material as the support is not needed to be removed upon completion of the regeneration. PLA material fulfills this requirement by being capable of being excreted through kidneys or removed in the form of carbon dioxide and water through metabolic processes. Additionally, PLA is highly biocompatible as its degradation product is lactic acid which is not harmful to the metabolic system. Furthermore, PLA performs optimally at a comparably low cost as a minor modification of its structure makes it suitable for additional application. This is a result of chirality of its base molecule – lactic acid – which poses dual asymmetric centres in four different forms. In some cases, the absorbability of scaffold works against the treatment objectives. In these cases, the scaffold needs to retain the strength while the cells are being slowly regenerated. The examples of this application are ligament and tendon reconstruction or stents for vascular and urological surgery.
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BIOPLASTICS
OF
References:
Vallet-RegĂ, M. Vila, M.. (2010). Advanced Bioceramics in Nanomedicineand Tissue Engineering. Trans Tech Publications Ltd. Grumezescu, Alexandru Mihai. (2016). Nanobiomaterials in Soft Tissue Engineering - Applications of Nanobiomaterials. M. Savioli Lopesa,b a, A. L. Jardinib, R. Maciel Filhoa. (2012). Poly (lactic acid) production for tissue engineering applications. Rajendra P. Pawara, Sunil U. Tekalea, Suresh U. Shisodiaa, Jalinder T. Totrea and Abraham J. Domb. (2014). Biomedical Applications of Poly(Lactic Acid). Ebnesajjad, Sina. (2013). Handbook of Biopolymers and Biodegradable Plastics - Properties, Processing and Applications. Van Blitterswijk, Clemens. (2008). Tissue Engineering.
THE EARTH In these cases PLLA fibres are used. Moreover, PLA composites can be engineered to be capable of simulating cells/tissues for proliferation and osteogenic differentiation in bone tissue engineering. Biologically, ligaments are bone connective tissues with reduced cell density. Among the human body ligaments, the anterior cruciate ligament, ACL, exhibits poor healing potential and limited vascularization. Thereby, ACL repair and regeneration is of an immense concern in the area of tissue engineering. There have been several biocompatible and biodegradable natural polymers used for ACL repair and regeneration, through tissue engineering, such as collagen fibre, silkworm silk-Nanofibrous matrix, alginate and chitosan polyion complex hybrid nanofibres, collagen platelet-rich plasma, etc. However, ACL regeneration using braided biodegradable scaffold made from synthetic polymers, particularly PGA, PLLA, PLGA, and PCL presented enhanced results. This is due to the thermal and mechanical properties of these materials.
While PLA solves many problems of tissue engineering, there are many is doesnâ&#x20AC;&#x2122;t. The hydrophilic property of PLA is poor and there are many mechanical properties ideal for scaffold that need to be fulfilled. PLA may disintegrate into small fragments which evoke a foreign body reaction. Additionally, since the surrounding tissue capability in eroding the byproducts is a function of vascularisation and metabolic activity, a low level of such activity would lead to the chemical composition of byproducts and local disturbance such as excess osmotic pressure or pH. Bioplastics, particularly PLA, are biodegradable materials with organic base which brings about a sustainable resource. Another important aspect of bioplastics is their biocompatibility which makes them usable in biomedical applications. Also, they are bio-absorbable which makes them more ideal in tissue engineering. PLA is made from lactic acid which is produced by bacterial fermentation of sugars. PLA is widely used in tissue engineering, due to its physical and chemical properties, to construct the scaffold. Although PLA presents a decent level of satisfaction in tissue engineering applications, its properties need to be enhanced to meet ideal requirements of tissue engineering.
Tissue engineering solves donation and transplant rejection problems, says Ramnes
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REGENERATIVE MEDICINE
A
Why does an orthopaedic biofabrication project HAVE POLYMERS AT ITS HEART
European transnational consortium led by Maastricht University (UM) will spend the next four years developing innovative bone implants. These implants will become an alternative for repeat surgeries, prolonged medication use and donor tissue implementation following complex fractures. The BONE partnership will also Biofabrication of bone provide the participating regions with a significant Orthopaedics in a economic boost, where advances in polymer processing will be central to innovation.
New Era (BONE) will study how Bone implants and consortium biodegradable Research has demonstrated that residents polymers of Northwestern Europe are more likely to develop degenerative bone disorders with bioactive in comparison with their EU counterparts. properties can As a result, this region has the highest number of bone fractures and bone defects within steer cell activity Europe, which has evident social and economic and tissue consequences. In the field of regenerative medicine, researchers have been working hard regeneration to create innovative bone implants that can
enhance recovery times and reduce health care costs. In addition to UM, this international partnership consists of the universities of Leuven (Belgium) and Lille (France), Fraunhofer Institute for Laser Technology ILT in Aachen (Germany), Medicen Paris Region, a leading biomedical cluster in Paris (France) and enabling technology companies The Electrospinning Company (UK), NKT Photonics (International) and Spraybase (Ireland). Over the next four years, these partners will work together developing the technology needed to produce these implants. The project initiators will also establish a roadmap to manufacture and market these implants at the end of the project, to ensure long term impact of their actions.
Technology At the basis of these smart bone implants lies an innovative technology, known as electrospinning. This technology enables researchers to create implants that have the potential to help the regeneration of healthy bone tissue. The surface properties of newly developed bone implants will be improved by providing enhanced bioactivity to a library of biodegradable polymers. The project will evaluate, in particular, polyesters, polyurethanes and copolymers. These classes of biodegradable and biocompatible polymers already have applications in a number of medical devices. Yet, the bone regeneration market is mostly comprised by autologic or allogenic bone grafts as golden standard clinical procedures, and by bone morphogenetic protein formulations and ceramics as alternative biologic and synthetic products. Whereas bone grafts are still linked to drawbacks such as morbidity (i.e. the lack of a bony site where bone could be taken), lack of revascularization and integration with the surrounding tissues, and risks of disease transmissions, their synthetic counterparts are costly (in case of bone morphogenetic proteins) and suffer from low mechanical properties (brittleness in case of ceramics). Polymers could provide a cost-effective solution. By engineering the surface properties of the above mentioned targeted polymers, the project aims to obtain similar biological activity as bone grafts and bone morphogenetic proteins, while improving upon the mechanical properties of ceramics. Furthermore, polymers offer the high flexibility to be synthesised with tailored end groups that could offer multiple sites for biological functionalisation. This could offer an appealing route to direct not only bone regeneration, but also vascularisation and innervation, aiming at an improved integration with the surrounding tissue.
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EXTRUSION
TIO tu b
-S vis is Da pert ex
ing
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CIRC
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oday’s medical tubing market is aimed at tubing that is smaller (less invasive) with tighter tolerances and higher overall quality. Processors also need to run at higher line speeds to improve efficiencies and cost competitiveness. While this creates a challenging climate for equipment manufacturers and system integrators, Davis-Standard has excelled in meeting industry demand head-on in terms of providing adaptable equipment solutions and extensive R&D capabilities. Davis-Standard’s track record in medical tubing is reflected in our global installations and growing market share. It is a key player in medical tubing equipment in the United States and has experienced a steady and consistent increase in overseas markets. Machinery, feedscrew and control options are available for nearly every medical tubing application including catheters, drainage and IV tubing, microbore tubing, radio opaque tubing, taper tubing and many others. Paramount to this versatility is the fact that Davis-Standard’s equipment can be designed to accommodate a wide range of materials ranging from polyolefins, FPVC and nylons to PLA, PLLA, PEEK and FEP. The company is always working
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al
t e t and ic ed hr ard m ive ’s ex ts s on plains how i ation perpetual innov
alongside customers to develop new applications, including innovative tubing processes that integrate Davis-Standard’s patented Alternate Polymer technology. This is complimented by the company’s commitment to fast response times, spare parts inventory and aftermarket service. “We are poised to take advantage of future medical tubing opportunities through continual development and unconventional solutions for complex products, engineered with features that surpass those of other extrusion equipment suppliers,” said Kevin Dipollino, product manager of DavisStandard’s Pipe, Profile and Tubing Systems. “We currently support a much higher degree of vertical integration than our competitors, which translates into a better overall experience for customers. Customers may perceive Davis-Standard as a large company. However, our tubing group operates as a small dedicated team, committed to customer needs. We have our own in-house engineering team, encompassing mechanical, electrical and software design. We also have the best lab and process engineers in the industry.”
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EXTRUSION
Twice as good: Davis-Standard (Suzhou) Plastics Packaging Machinery Co lab extruder. This is the company’s secondary lab
We are poised to take advantage of future medical tubing opportunities Kevin Dipollino, Davis-Standard
According to Dipollino, the availability of R&D processing labs is a significant advantage for Davis-Standard customers. The company has its principal medical tubing lab at its headquarters in Pawcatuck and a secondary lab in China at its subsidiary in Suzhou, Davis-Standard (Suzhou) Plastic Packaging Machinery Co. The medical tubing line in Connecticut is located in a climate-controlled clean room type environment for customers to test new resins, make parts for proof-of-concept, and conduct R&D trials prior to making large capital equipment investments. Examples of current machinery innovations include tight tolerance processing of FEP tubing with radio opaque stripes, the MEDD (Medical Extruder Direct Drive) extruder, and the Alternate Polymer technology. The FEP line is ideal for medical applications requiring biocompatibility and lubricity. The compact MEDD is optimised for clean room environments with a replaceable feed section liner and direct drive technology for greater efficiency and materials flexibility. Davis-Standard offers a high-tech melt pump system to maximise stability when processing sensitive materials. With Alternate Polymer
technology, processors can switch from polymer A to polymer B using precision extruders and melt pumps with highly accurate servo drives to toggle between resins. “With continued growth in the medical tubing market worldwide, our R&D lab lines have been an extremely important asset for both Davis-Standard and our customers. These lab lines have also supported our efforts to stay ahead of the game and bring competitive solutions to the industry,” said Dipollino. As for the future, Dipollino and his team at Davis-Standard are optimistic. The company has seen substantial growth for medical devices in the Asia Pacific market, as medical treatments align with those in the U.S. and Europe. Dipollino believes global demand for medical tubing will remain strong due to aging populations and increased awareness regarding quality of care and patient safety. An example of a niche market that Davis-Standard has capitalised on is equipment for processing radio opaque tubing for catheters. The company has a strong pipeline of projects and is expecting to finalise key partnerships with medical companies that will support a strong finish to 2017 and future expansion.
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EXTRUSION
Weighing in THE PROS AND CONS OF PROCESSING METHODS FOR MEDICAL POLYMERS
W
ith biofluid compatibility, favourable haptic as well as physical, chemical and processing attributes, silicone’s popularity for use in medical devices continues to grow. Advancements in medical polymer architecture further facilitate many novel next-generation medical devices and implants.
Drew Rogers, Trelleborg Sealing Solutions, looks at extrusion and moulding, and the advantages and disadvantages of processing methods for medical silicone polymers
Bringing together the ideal combination of material, component design and manufacturing process within the right framework of regulatory compliance is the key to fulfilling a device’s intended fit, form and functions reliably. Expertise from a silicone and polymer processing specialist, and due diligence at the early stage of concept and development, pay tribute later for timely and smooth market launch and industrialisation. We’ll review the advantages and disadvantages of several types of processing for silicone and medical polymers.
1. Injection Moulding
Injection moulding allows highly efficient high volume manufacturing of components in – depending on sophistication of tooling – very complex and intricate geometries. Cavitation per mould is tailored from one to several hundred depending on complexity of part and capacity needs. A part and application may lend itself to be produced from liquid silicone rubber (LSR) in a liquid injection moulding (LIM) process. LSR has the potential to be used in combination with an engineered plastic using a 2-shot (or more) fully automated injection moulding set-up. In line with the complexity of the finished product, developing a tool-grade steel mould, hot- or cold-runner blocks, and process automation equipment can be expensive upfront. However, at high volume and over the life of a program, the
tooling costs per part can actually be quite low. Injection moulding, and even more so LIM, can produce high integrity parts over very high volumes. The moulding efficiency depends on decisions and choices made around mould and process design as to details such as cavitation, basic tool construction, gating, venting, surface finish, and supporting automation. It will also need to integrate seamlessly with equipment that pumps, mixes, injects, compresses, heats and ejects. Creating a mould for a seal to be used in a medical device typically requires early, close collaboration between engineering teams at the device maker and the seal supplier. This will ensure the correct material selection and adherence to regulations, while minimising variability, maximising yield, and reducing costs by optimising seal geometry, tooling and process engineering. ADVANTAGES OF INJECTION MOULDING Liquid Injection Moulding • Facilitates complex designs; ideal for parts with a large amount of detail such as undercuts or thin wall sections • Ideal for micro- and nano-sized parts • Accommodates hard-soft combinations via a 2-shot LSR process • Highest efficiency of any moulding method with short cycle times and possibility of full automation • Ideal for very high volumes in flashless quality Injection Moulding • Enhanced strength; fillers can be used to reduce the density of the silicone while it’s being moulded, further strengthening the moulded part • Multiple silicone types can be utilised and tailored to the application conditions and moulding process requirements • Metal or plastic elements can be integrated into the part • Efficient process for technical parts in medium to high volumes in semi-automation
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EXTRUSION DISADVANTAGES OF INJECTION MOULDING
Injection Moulding
popularity, the latter due to its increased purity and faster production cycle. Thanks to advances in thermoplastic polymers, such as polyether ether ketone (PEEK), polyurethanes, and polyolefins, plastic tubing is replacing metal tubing in many medical devices. PEEK is an excellent alternative to stainless steel because it is very strong and has a low friction coefficient. Similarly, both PEEK and polyphenylsulfone (PPSU) are used for long-term implantable components because of their biocompatibility.
• Design restrictions, including the fact that all parts must be solid and must have drafting if they are perpendicular to the tool opening
ADVANTAGES OF EXTRUSION
Liquid Injection Moulding • Highest initial tooling cost that must be considered as an investment over the life of a tool; which is, however, the longest of any type of injection moulding tool, i.e. typically one million shots
• There may be restrictions on part thickness to avoid shrinkage problems
• Accommodates high production volumes
• Requires part de-flashing operation with additional cost
• Provides efficient melting
2. Compression moulding
• Offers considerable flexibility in manufacturing products with a consistent cross-section
The compression moulding process is ideal for parts beyond the size capacity of extrusion or injection moulding and for moderately complex parts in low quantities. The process is used in medical applications such as diaphragms for respiratory equipment, lip seals for cylinder applications, and isolation bumpers used to inhibit vibrations. Compression moulding is also used to manufacture thermoset plastic parts. The raw materials for compression moulding are either granules, putty-like masses, or preforms. The raw material is placed in an open, heated mould cavity to which pressure is applied, forcing the material to fill the cavity. ADVANTAGES OF COMPRESSION MOULDING: • Cost-effective for smaller volumes; low tool costs • Parts can be made to customer specification from specified materials • Flexible mould design • Tools with multiple cavities can be created • Quick turnaround of tools and parts • Good surface finish DISADVANTAGES OF COMPRESSION MOULDING: • Slower part production rates • Involves largely manual process steps • Requires post-moulding operations to remove flash • Precision is good but limited to a normal level for rubber parts • Largely used for simple to moderately complex shapes with no undercuts A further option for production of moderate quantities of complex rubber part geometries is transfer moulding. Here, the elastomer is first heated in a pod to then be injected into the hot cavity.
3. Extrusion Silicone is well established as a completely inert, biocompatible and very versatile material in medical extrusion. In medical devices, both peroxide and increasingly platinum-cured silicone grades enjoy increasing
• With plastics, allows for post-extrusion manipulations
DISADVANTAGES OF EXTRUSION • Difficult to predict the exact degree of expansion • Subject to size variances • Some product limitations
4. Multiple-Profile Extrusion (MPE) MPE eliminates secondary bonding operations through its ability to mate with a variety of tube profiles. The process produces a single, continuous tube, eliminating the need for leak testing. It also provides ‘on the fly’ manipulations, allowing the cross-sectional profile of a silicone tube to change during extrusion, reducing costs. The absence of a seam also greatly enhances product performance, mitigating areas where bacteria can accumulate. With MPE, there is no need for secondary bonding, thereby reducing costs and increasing production speed. Double extruder configurations allow for a wide range of stiffness and flexibility in tubes. The amount of flexibility can be controlled by thinning out the extrusion wall or switching to a softer or stiffer material anywhere along the extruded profile. Within the MPE process, two or more lumens can easily be split off a centre lumen or merge two lumens into a single lumen – all in a single continuous extruded tube. The multi-lumen process involves moving dies and mandrels in sync, reducing cross contamination of fluids in the separate lumens. ADVANTAGES OF MULTIPLE PROFILE EXTRUSION • Facilitates the extrusion of balloons of any length • Removes secondary bonding operations • Allows for seams to be eliminated • Various types of tubing (single lumen, multi-lumen, transitional GeoTrans, etc.) can be produced, as well as rod, ribbon, and other non-standard profiles • Suitable for extruding both elastomers and foams DISADVANTAGES OF MULTIPLE PROFILE EXTRUSION • Material choices limited to HCRs (high consistency rubber) • Issues can arise from having to move dies and mandrels in sync • Cross contamination of fluids in the separate lumens can occur Conclusion The ability of silicones and thermoplastic polymers to be formulated and processed to attain specific performance, aesthetic, or therapeutic outcomes makes them ideally suited for many medical devices. Device designers and makers – either at OEM or CMO basis – need to have a basic understanding of the diversity of processing options available, or, better yet, bring on board from the early concept stage of a new device a processing expert for silicone and other polymer components. With time-to-market being such a critical element in the creation and sale of medical devices, the ability to produce rapid prototypes, quickly reach a final design, and consistently produce and deliver high-quality products, are the keys to success.
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10:2017 THE DEVICE PROVIDING A SMART ANSWER TO CARDIAC MONITORING
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Back for good
SMART UNDERWEAR TO AID BACK PAIN
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team of Vanderbilt University engineers is hoping to crack the problem of back stress with smart underwear that uses biomechanics to help reduce pain on this part of the body. The device consists of two fabric sections, made of nylon canvas, Lycra, polyester and other materials, for the chest and legs. The sections are connected by sturdy straps across the middle back, with natural rubber pieces at the lower back and glutes.
It is designed so that users engage it only when they need it. A simple double tap to the shirt engages the straps. When the task is done, another double tap releases the straps so the user can sit down, and the device feels and behaves like normal clothes. The device also can be controlled by an app that the team created—users tap their phones to engage the smart clothing wirelessly via Bluetooth.
collaboration between the Medical University of Vienna and the Ludwig Boltzmann Cluster for Cardiovascular Research, has created an algorithm and a recording device which means it is now possible to monitor people fitted with cardiac pumps – otherwise known as ‘smart pumping’. According to Heinrich Schima and Francesco Moscato from MedUni Vienna’s Center for Medical Physics and Biomedical Engineering: “This is the most intelligent pumping system in the world.”
It provides detailed analysis of the cardiac output and the pump output and is currently still at the research stage. It is hoped that, in future, the data can be called up at any time in the course of clinical practice, thereby allowing personalised therapy. There are currently 20 patients at the Division of Cardiac Surgery implanted with a mini heart pump that uses the smart system – this as a bridging measure while they are waiting for a heart transplant. “We are able to measure and analyse cardiac arrhythmia, blood clot formation and also blood pressure crises,” says Moscato.
Check out...
T
he camera that sees through the human body. The result of a collaborative project at the University of Edinburgh and Heriot-Watt University, the device works by detecting sources of light inside the body and has been designed to help track endoscopes that are used to examine internal conditions.
“This is an enabling technology that allows us to see through the human body. It has immense potential for diverse applications. The ability to see a device’s location is crucial for many applications in healthcare, as we move forwards with minimally invasive approaches to treating disease.”
Professor Kev Dhaliwal, of the University of Edinburgh, said:
Dr Michael Tanner, of Heriot-Watt University, said: “My favourite
element of this work was the ability to work with clinicians to understand a practical healthcare challenge, then tailor advanced technologies and principles that would not normally make it out of a physics lab to solve real problems. I hope we can continue this interdisciplinary approach to make a real difference in healthcare technology.”
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