MEDICAL PLASTICS news
Brain Waves Phillips-Medisize applies intelligent thinking to drug delivery devices
+ SPOTLIGHT ON INNOVATION MEDTECH INNOVATION EXPO 2017 WORKING WITH BIOABSORBABLE POLYMERS
ISSUE 35
Mar-Apr 2017
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Stand No: 1M28
CONTENTS Mar-Apr 2017, Issue 35
Regulars
Features
5 Comment
21 Taking shape Why thermoforming has a key role to play in medetch
7 News focus How 3D Hubs’ expertise is helping neonatal surgery 8 Digital spy 11 News focus Industry first embedded device
22 Leaders of the pack Lu Rahman looks at some of the stand-out companies in the medical plastics world 25 What’s the name of the game? IDC outlines the importance of a product name in China
15 News analysis What’s behind Brazil’s medtech success? 18 Cover story Phillips-Medisize reveals the intelligent way to do drug delivery devices 46 04:2017 The medtech info you really need to know
33 Stick it out Dyne Technology looks at the problems of adhesion 37 World vision Davis-Standard and Graham Engineering describes their extrusion expertise 41 Forming an attachment Techsil explains how to choose the right adhesive when bonding elastomeric materials
28 Let’s get down to business What the Medtech Innovation Expo has in store for visitors
42 Disappearing act Polymer Solutions and how to manage change when deadline with bioabsorbable polymers
31 Little things mean a lot Ambionics develops breakthrough child prosthetic using 3D printing
45 Smart move APMT explains how its ACOMP system helps control polymer properties for medical applications
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CREDITS
EDITOR’S
group editor | lu rahman
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f you live in the UK you’ll have heard of Brian Cox – trendy physicist who’s made science and astronomy cool again. Recently he spoke about Mars, in particular billionaires investing enormous amounts of money with the aim of getting people on the planet, possibly within the next ten years.
significantly in the last few years. Healthcare professionals have to come to rely on connected devices to monitor and improve patient outcome and adherence. Meanwhile, from booking appointments, to ordering and administering medication, the patient expects to use digital systems.
Medical Plastics News is published by: Rapid Life Sciences Ltd, Carlton House, Sandpiper Way, Chester Business Park, Chester, CH4 9QE
It sounds fantastic, the stuff of which movies are made but this could become a reality. Anyone who regularly uses the UK’s motorway network will know how hard it is travelling 40 miles. The thought of 249m miles to the red planet does seem a stretch too far.
With this in mind, I hope that as many of you as possible can make it to the Medtech Innovation Expo in Coventry on 26 and 27 April. This is the only event in the UK that brings together technology, manufacturing and innovation from the UK and Ireland’s buoyant medtech sector, so promises to be packed with the latest manufacturing solutions as well as providing a great base to make new business partners and take advantage of the opportunities available by supplying the healthcare sector.
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Thankfully there are those among us who have no limits to their imagination and thanks to them science and technology moves forward. If we look back ten or 15 years – the days our phones were just phones, we used paper maps and carried separate cameras – it’s clear how quickly we’ve come to accept technology and adapt to what it offers. How easy has it been to rely on the convenience offered by being online anytime we want, to get to places with ease and do simple things like book a film or our grocery shop in a matter of minutes?
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With this in mind, I hope that as many of you as possible can make it to the Medtech Innovation Expo in Coventry on 26 and 27 April
The event will be well worth a visit and who knows, in a decade or so, we might be inviting you to its Mars launch event...
The medtech sector is no exception. Whether it’s materials, innovation in machinery and product design, the ability to drive faster and more efficient production or the introduction of digital technology into devices, the rate of change has been immense. Both the consumer and the manufacturer have come to expect high levels of quality and technology in their products. As wearable devices become a staple in our lives – be it for fitness of health – their functionality has developed WWW.MEDICALPLASTICSNEWS.COM
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Model answer: 3D printed models offer a unique insight into the anatomy of a patient
How 3D printed babies are helping train doctors
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indhoven’s University of Technology is home to PhD candidate and Healthcare Flagship Program participant, Mark Thielen, who is aiming to increase surgical and procedural success for Ben Redwood, 3D neonatal patients. Using 3D printing and 3D Hubs, explains Hubs, Thielen has developed an optimised training experience using lifelike newborn how Eindhoven’s models with functional organs capable of University of intelligent sensor feedback.
Technology has developed a new neonatal training technique with help from 3D Hubs
For surgeons and nurses, interacting with anatomical models is important to the success of surgeries and medical procedures. Within the neonatal field, it’s incredibly difficult to practice correctly with the current state of practice mannequins which lack the complexity and feel of a newborn patient. Thielen’s research is to develop mannequins which have all their major internal organs functioning and equipped with sensors to monitor key measurements such as pressure, stress and impact during trial procedures (eg CPR, intubation). 3D printing is utilised because of the vast materials available for testing and, most importantly, the organic shapes the technology is able to create. There are two key components to the mannequin: The ribcage/spine, which acts as the housing for the second component, the internal organs. The sheer complexity of human anatomy is very hard to recreate realistically with any other production method as well as increased cost and lead times.
traditional manufacturing methods, 3D printed moulds allowed for rapid design changes. Material jetting also allowed the combination of materials (rigid and flexible plastics) when creating the moulds. A heart, for example, needed to have highly detailed working valves. Due to the extremely small sizes of neonatal organs, as well as their minuscule detail, the only way to create a mould for these parts was to 3D print them. When the ribcage and organs are combined, Thielen runs a fluid through the mannequin with two cameras and sensors installed, giving feedback on every part of the model throughout various trial procedures. Thielen’s research into the creation of hyper-realistic mannequins doesn’t stop at neonatal patients though, with there being potentially wider applications. He explained: “I believe that developing and advancing what we started here can aid medical research in a broader scope. We could potentially create realistic patient models of other body parts to strengthen medical training for emergency procedures and pregnancies.” This project was made possible by the D.search lab and Jasper Sterk who both have provided a great contribution to this work.
Press print: A 3D printed mould was used to produce the highly detailed internal organ models
Testing was initially done with various thermoplastic elastomers on a desktop FDM 3D printer to create the larger parts of the model such as the rib cage. After finalising on a design, Selective Laser Sintering (SLS) was used because of the accuracy and dimensional freedom the technology offers. To create the functional organs material jetting 3D printing was used to create moulds. When compared with WWW.MEDICALPLASTICSNEWS.COM
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DIGITAL
DEVICE UPDATE
www.brainscope.com
spy
AHEAD OF THE GAME:
DEVICE SPEEDS UP CONCUSSION DIAGNOSIS
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BREAKTHROUGH
www.news.berkeley.edu
What’s the point?
Oral drug delivery could take the edge off vaccinations Needles could be a thing of the past if new drug delivery device takes off
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t may not have the most appealing product name but the Mucojet could be a real game changer in the drug delivery device market. It’s hoped that one day this pill-sized cylinder will be able to administer vaccines via a jet inside the mouth – all without a needle. The device is the work of researchers at University of California, Berkeley, who have carried out a proof-ofconcept study conducted at the university. According to Berkeley News the study didn’t test Mucojet on people but found that is could deliver vaccine-sized molecules to immune cells in the mouths of animals. It says the device is one step closer to improved oral delivery “which holds the promise of building immunity in the mouth’s buccal region of cells, where many infections enter the body”. Patients hold the device against the inside of their cheek and the device releases a jet stream aimed at the buccal region. According to the university: “This region is rich in immune cells but underutilised in immunology because of the challenge of efficiently penetrating the thick mucosal layer in this
part of the oral cavity with existing technologies, such as the oral spray often used for influenza vaccination”. Kiana Aran, lead author of the study said: “The jet is similar in pressure to a water pick that dentists use. The pressure is very focused, the diameter of the jet is very small, so that’s how it penetrates the mucosal layer.” The researchers tested the Mucojet on cheek tissue from pigs as well as live rabbits. The tests simulated how oral flu vaccine are administered and showed that the pressure of the jet improved the efficiency of the drug delivery.
ccording to BrainScope, its Ahead 300 device will lead to a speedier diagnosis of concussion in sports players, which can currently take up to 30 minutes. The device was approved by the US Food and Drug Administration (FDA) last year and uses electroencephalography (EEG) capabilities plus algorithms and machine learning to provide a results. Speaking to the Irish Times company CEO, Michael Singer said: “We have created this capability, where there are elements that may already be used by clinicians and we put those on the device in digitised format.” “We are thrilled to be introducing the Ahead 300 to the market. We
www.chinaplasonline.com
chinaplas 2017 focus on medical
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hinaplas 2017, which takes place on 16 – 19 May in Guangzhou, China, will offer a special focus on the medical plastics sector. The last event welcomed 148,575 visitors, among which 39,454 were overseas visitors from over 160 countries and regions. This year’s event will showcase plastics and 3D printing for the medical industry. Certain modified plastics offer excellent biocompatibility and help drive the medical industry’s
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“This is a brand new product, a pioneering product,” added Singer. “There’s a group of core clinical sites, all in the US that we are beginning with, hospitals, sport and some others.”
EVENT UPDATE
The researchers state that their data indicates the immune response should be at least as good as that administered via a needle. The MucoJet also reduces the biohazardous waste that comes from disposing of used needles, and can be administered at home by the patient, without needing a medical professional on hand. Aran said: “Imagine if we could put the MucoJet in a lollipop and have kids hold it in their cheek. They wouldn’t have to go to a clinic to get a vaccine.”
strongly believe this medical device represents a paradigm shift in how clinicians will address the multitude of challenges they face when they assess mildly presenting headinjured patients,” continued Singer. “The Ahead 300 is the firstto-market medical technology capable of providing objective, easily accessible and multimodal information in a panel format for up to three days following injury. As the first line of assessment, the Ahead 300 can have significant impact on helping the clinician make their diagnosis for proper patient disposition.”
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rapid development. At Chinaplas 2017, suppliers of healthcare materials such as silicone rubber, bio-safe resins and new polymers that offer strong resistance to gamma rays will all be on show. As the medical industry has also been an enthusiastic adopter of 3D printing and wearable technology, the event will launch a 3D Technology Subzone offering the latest in additive manufacturing technologies, equipment, and materials. It is a must-see zone for experts from the medical and other industries.
DIGITAL SPY
DIGITAL NEWS
Strong growth ahead for medtech sector, says report www.visiongain.com
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new report by Visiongain predicts the global medical devices market will reach $398bn in 2017. The industry generated $321bn in 2012, and its revenues will show strong growth to 2023. That revenue forecast and others appear in Medical Devices Industry and Market Prospects 2013-2023. The report predicts that the medical devices industry will offer significant opportunities for growth in the coming decade. Visiongain believes that market expansion will be driven by the introduction of innovative devices into the market and also by the demand generated by illnesses associated with the ageing global population. In 2012, the top twelve companies in the medical devices industry controlled 45.9% of the global market. This dominance is however being challenged by companies
talking
POINT
with intentions to enter the medical devices market. Samsung, for example, has been implementing a growth through acquisition strategy in order to compete with other leading electronic companies who have also recently invested in the medical devices market. Moses Akintomide-Akinwamide, a pharmaceutical and medical devices industry analyst in Visiongain said: “Growth in the medical devices industry will be driven by the rapid expansion of the emerging markets, allied with steady growth in mature markets as the effects of the economic crisis begin to fade. The expansion of the middle class income group in emerging economies will result in a larger proportion of the population being able to afford procedures and treatments that were previously deemed too expensive.”
Wearing your heart on your sleeve Robotic device helps failing hearts to beat by mimicking healthy cardiac muscles Really? A heart on a sleeve? Well, more of a soft robotic sleeve which can help a heart to beat. It’s been developed by Dr Ellen Roche of National University of Ireland Galway. The sleeve wraps around the organ, twisting and compressing in synch with the beating heart, potentially opening new treatment options for people suffering from heart failure.
DIGITAL NEWS
S
www.smitherspira.com
DEVICE TESTING LAB PASSES ACCREDITATION AUDIT
mithers Pira’s Medical Device Testing Laboratory in Shawbury has been successfully assessed by UKAS auditors and is expanding it accredited testing as a result.
Dye solution tightness test: BS ISO 110404:2015 (Annex H)
The assessments covered a range of commonly performed tests. Once the paperwork is completed the company expects to have the following tests methods included to its accredited scope allowing it to apply the ILAC stamp to reports which cover testing performed to these standards:
Syringes: Plunger operation force BS EN ISO 7886-1:1997 (Annex G)
Vials: Container closure seal integrity BS EN ISO 8871-5:2016 (Annex D) Prefilled syringes: Breakloose and glide force BS ISO 11040-4:2015 (Annex E); BS ISO 11040-8:2016 and
Needle-based injection systems; Dose accuracy; BS EN ISO 11608-1:2015
These tests are core components of Smithers Pira’s testing programme in its Shawbury facility, where it offers a broad range of medical device testing services. Chris Berry, manager of medical device testing at Smithers Pira, said: “Updating our accredited scope demonstrates our commitment to quality assurance and our willingness to comply with client requests”.
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How is it different to other systems? Ventricular assist devices (VADs) are already used to sustain end-stage heart failure patients awaiting transplant. They extend lives albeit at a high risk due to the number of complications that can occur resulting from their design. This includes clotting requiring patients to take blood thinner medications. The soft robotic sleeve does not directly contact blood, avoiding that risk. What’s the plan for the device? With heart failure affecting 41 million people worldwide, the hope is the device may one day be able to bridge a patient to transplant or to aid in cardiac rehabilitation and recovery. What inspired the device? Researchers took inspiration from the heart itself. The thin silicone sleeve uses soft pneumatic actuators placed around the heart to mimic its outer muscle layers. The actuators twist and compress the sleeve in a similar motion to the beating heart. The device is tethered to an external pump, which uses air to power the soft actuators. “The sleeve can be customised for each patient”, said Dr Roche. If a patient has more weakness on the left side of the heart, for example, the actuators can be tuned to give more assistance on that side. The pressure of the actuators can also increase or decrease over time, as the patient’s condition evolves. More research needs to be done before the sleeve can be implanted in humans but the work is an important first step towards an implantable soft robot that can augment organ function. 9
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meet us at Medtec Europe 2017 Stand 1B10 4 - 6 April 2017 Stuttgart, Germany
NEWS FOCUS
Small is beautiful:
Embedded device marks industry first
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he newly released ADLEPC-1500 from ADL Embedded Solutions makes use of one of the industry’s smallest Intel-based Atom single board computers (SBC), resulting in a very small compact ADL Embedded Solutions, embedded PC at 1.3” x 3.4” x 3.2”. While the Intel Atom cannot compare provider of high- with ARM microprocessors with performance embedded respect to low-power, it more than solutions, recently makes up for it with much higher released what it says is the compute and graphics performance with power starting at 3W for an Intel industry’s smallest Intel- E3805 dual-core and extending to based embedded device. JC 10W for the Intel E3845 quad core Ramirez, the company’s processor.
product manager, outlines how the device is suitable for a variety of medical device applications
The ADLEPC-1500 is a full-featured embedded PC providing USB2.0, USB3.0, DisplayPort, dual LAN ports and onboard M.2 SATA storage which is sufficient for most intelligent control applications for machinery, equipment, or IoT devices. A board-end connector provides added PCIe, SATA, GpIO, and USB outputs, allowing the ADLEPC-1500 to easily expand to larger I/O requirements for related products while standardizing on a common computing platform.
Suitable for medical devices While the ADLEPC-1500 is small enough to fit the definition of wearable-computing in other industries, wearable medical devices remain the domain of ARM-based devices with much smaller size, weight and power, and performance. Instead, the ADLEPC-1500 is ideal for traditional laboratory diagnostic and analysis equipment which has traditionally been the domain of larger embedded PC systems but are increasingly being made smaller and more portable for ease of movement or in-room use. For ADL Embedded Solutions customers, these applications have included blood analysers, cardiac simulation tools and equipment, urology imaging systems, medical lasers, blood separation equipment, 3-D eye mapping, and ultrasound imaging.
The ADLEPC-1500 enables future cloud-computing and IoT applications by bringing intelligent control to the edge of the network fabric directly onto machinery and equipment. It is compatible with enterprise cloud computing platforms like Microsoft Azure under Linux and Windows operating systems. Healthcare IoT, sometimes termed IoHT (Internet of Healthcare Things) serves to monitor and track data being gathered at all levels of the healthcare systems including patients, medical equipment, logistics and distribution of pharmaceuticals, and much more. In these use scenarios, the ADLEPC-1500 can perform the function of a data aggregation hub with enough capacity and intelligence to monitor, store, analyse, and link to the cloud for enterprise applications.
What it means for medical device manufacture A common requirement in the medical device space is the need for stability and future-proofing of their products. What this means for embedded hardware vendors such as ADL Embedded Solutions is that aside from meeting the technical requirements for an application, we also prioritise providing intangible benefits such as long product life availability (7 years plus), obsolescence management for end-of-life components, hardware revision control, firmware and BIOS revision control, customization services for both hardware and firmware, direct access to engineering and design teams, FAE support and readily available technical support. This is especially critical for healthcare devices and equipment where the rate of product improvement and innovation is continuously being accelerated by the advent IoT needs and requirements. Tiny takeover: The ADLEPC-1500 is ideal for traditional laboratory diagnostic and analysis equipment
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NEWS FOCUS
Cybersecurity and medical devices:
Expert advice
Cybersecurity threats are an increasing worry to medical device businesses. Nova Leah offers expert advice in the safeguarding of medical devices. The company’s founder Anita Finnegan discusses the significance of the company’s work Cybersecurity threats to connected medical devices are real, everpresent, and continuously changing according to the US Federal Drug Administration (FDA). Hospital networks are experiencing constant attempts of intrusion and attack posing a serious threat to patient safety. Increased connectivity of medical devices to hospital IT-networks provides significant benefits to patient care but also exposes both manufacturers, healthcare providers and patients to cybersecurity risks which can affect the safety of between 10 and 15 million connected devices currently being used by patients. The FDA has now published guidelines for post-market cybersecurity risk management of networked medical devices. This is in addition to the FDA’s pre-market guidance issued in 2014. This guidance document recommends that manufacturers now consider cybersecurity throughout the entire lifecycle of a device by developing “a structured and comprehensive program to manage cybersecurity risks” even after their products have been sold. The newly published post-market recommendations provide device manufacturers with a set of practices designed to assure the security of devices once in use. These include: Monitoring cybersecurity information to help identify and detect vulnerabilities. Maintaining software life-cycle processes such as: Monitoring third-party software components for new vulnerabilities. Design verification and validation for software updates and patches. Using threat modelling to help maintain the safety and performance of a device. Mitigating cybersecurity vulnerabilities early and before they are exploited. The FDA pre-market recommendations include:
Identification of assets, threats and vulnerabilities. Assessment of the impact of threats on device functionality and
patients.
Assessment of the likelihood of a threat or a vulnerability being
exploited. Determination of risk levels and suitable mitigation strategies. Assessment of residual risk and risk acceptance criteria.
Manufacturers can do this by building-in security controls during the product design phase and by continuously monitoring devices to address on-going cybersecurity concerns. Importantly, the FDA also recommends collaboration between stakeholders (medical device manufacturers, health IT developers, IT system integrators and end-users) as an effective approach to addressing risks through cyber-threat information sharing. The onus is now very much on medical device manufacturers to adopt a proactive and vigilant approach to evolving cybersecurity threats and vulnerabilities when designing, developing and maintaining the security of their medical devices.
Expert medical device risk assessment with SelectEvidence SelectEvidence is a collaborative cybersecurity expert system that supports medical device manufacturers in designing, verifying and certifying connected medical devices to meet these FDA guidelines and industry security standards. It also assists healthcare providers in the selection, acquisition and risk management of medical devices on their healthcare networks. The system allows stakeholders to implement cybersecurity requirements for their devices using proven standards within a collaborative framework. It is supported by state of the art repositories which inform each step of the cybersecurity management process providing full traceability from risk identification to treatment thus significantly reducing the time a manufacturer spends working on risk assessments. It also: Accelerates medical device design, development and validation. Reduces time-to-market for new 510k and PMA submissions. Reduces costs associated with post-market surveillance
documentation and reporting.
Prevents the likelihood of recalls due to cybersecurity vulnerabilities. Breaks down knowledge barriers between manufacturers and
healthcare providers, improving the security of a device over its lifetime. Reduces the time spent selecting security controls to support a device in operation. Produces documentary evidence of compliance to regulators, auditors and customers.
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NEWS ANALYSIS
What’s behind Brazil’s medtech success? Renowned for its prowess on the football field, Brazil also boasts an innovative and dynamic medical devices sector. ABIMO (the Brazilian Medical Devices Manufacturers Association) outlines what’s behind this industry which accounts for 95% of the internal market and which generates 60,000 domestic jobs Brazil is seen as one of the most lucrative healthcare markets in Latin America, consistently being placed among the top five medical tourism destinations in the world. According to the Brazil Healthcare Market Outlook 2020 study by ReportLinker, an international marketing research company, an improvement in the country’s living standards has resulted in steadily increasing healthcare expenditure, which is driving the sector. The CAGR (compound annual growth rate) for medical expenditure in Brazil has been forecast at approximately 5.8% between 2016 and 2020. Among the main reasons behind the increasing healthcare expenditure are the prevalence of various diseases, including hypertension, cancer, tuberculosis, obesity and diabetes. The report also emphasises the positive impact of major mergers and acquisitions that took place in the sector, in 2015, on the country’s healthcare market and IT industry. The healthcare products sector in Brazil is segmented into: odontology, laboratory, radiology, medical devices, implants and consumable supplies. The industry is innovative, proactive and competent, able to supply 95% of the domestic market and exports to countries such as Angola, Chile, Spain, the US, India, Mexico, Russia, Turkey, Saudi Arabia, Iran, Colombia, the UAE and China – generating approximately 60,000 of the country’s jobs. Export sales of the sector’s products just for the period January to October 2016 came to a total of under US$ 560 million.
Investment opportunities Health device companies in the US, Germany, China, Japan, the UAE, Russia and African countries, among others, are increasingly turning their gaze to the Brazilian market. Competitive prices and growing investment by hospitals into solutions that optimise time and facilitate daily healthcare centre management routines are the main arguments used by international companies looking to do business in the country. In the assessment by ABIMO (the Brazilian Medical and Dental Devices Manufacturers Association), Brazil, with its growing market, represents an excellent opportunity for companies who are looking for medium and long term business. ABIMO superintendent Paulo Henrique Fraccaro explained: “We are going through a period of profound transformation, because the growth in demand and changes in healthcare device consumption are leading to a maturing sector. We are producing more, at higher quality and lower cost and believe that the changes in the general landscape are once again lifting up Brazil’s image abroad.” Another fundamental factor was the change to Act 8,080/1990 in January 2015, which came to allow foreign capital companies to participate directly or indirectly in healthcare assistance and in running private institutions. The new legislation also allows for companies to operate in hospitals, general and specialised clinics, corporate customer services, laboratories and philanthropic services, further expanding the interest in Brazil as a target market.
Challenges: innovation and competition Innovation has contributed to Brazil’s medical-hospital dynamism. Companies are increasingly investing in innovation and are encouraged to innovate within a highly competitive environment. The competition spans from multinationals with innovative technologies and huge product portfolios to micro-businesses. The country is considered to be the only one in South America to have a relatively complete industry for the manufacturing of medical-hospital devices and consumables. Clara Porto, ABIMO’s head of marketing and exports, explained: “Brazil has been maturing and we understand that in the present, dynamic global state of competition investing in innovation becomes our reality.” Since the 1970s, quality certification and systems have been consistently worked on by ABIMO, which created the Innovate Health Award in 2010, aimed at stimulating the country’s R&D into new technologies. One award is given to an industry in the medicalhospital sector and another to one in the odontological sector for a product or service that stands out as an innovation in the national production chain and that has, in that sense, contributed to the development of technologies that champion quality in healthcare. Fraccaro emphasised: “ABIMO believes that encouraging the domestic industry, regardless of a company’s size or area of operations, is favourable for the country, which gains in technology, as well as for society as a whole, which benefits from new solutions and opportunities.”
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MEDTECH EUROPE
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Christophe Amiel from Voisin Consulting and David Kleidermacher chief executive officer of BlackBerry will explain how this sector is evolving and how their companies are helping in the matter. Conferences and seminars will be running simultaneously, all of which will touch on some of the most trending topics in the industry. Taking advantage of growth prospects will also be covered such as Opportunities in the Nordics during the year the Breakfast Meetings.
very year Medtec Europe brings together the medical device industry under one roof for three days. This year the event boasts more content and networking possibilities to allow visitors to attract even more business. The healthcare sector is constantly looking for solutions that aid an ageing population and Medtec Europe presents innovation from the medical device sector, discusses trending topics as well as providing a range of experts talking about the market’s latest technology.
Medtec Europe 2017 - more content, innovations, startups and tools, say organisers
Medical device manufacturing conference This year, Medtec Europe on 4-6 April, Stuttgart, has partnered with Frauhofer IPA and Messe Stuttgart to organise a conference dedicated to the medical device manufacturing sector. Experts from the industry will be sharing their knowledge and perspective on the future of this market.
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This event boasts Best innovations and start-ups! more content and networking The medical device industry is thriving in an possibilities to increasingly technological world. To highlight allow visitors to the importance of keeping up with this constant attract even more evolution, Medtec Europe 2017 has created the Innovation Gallery showcasing a series of business.
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The conference will take place the 5 April at Messe Stuttgart and will be running parallel to the Medtec Europe 2017 show. It will discuss important matters within the medical device industry such as clinical aspects and innovations and regulations. High quality speakers including doctors, professors and representatives from companies such as Aesculap, Fraunhofer IPA or AB Certification will be coming from all regions of Germany to share expertise,
Digital health The event will also feature a conference stream covering digital and mHealth highlighting how healthcare can be made personalised, accessible and convenient.
exhibits from prosthetics to mobile applications. It has also put in place the Start-Up Academy which not only rewards a company for its uniqueness and relevance to the industry but also offers mentoring support to aid success.
Tools to succeed at Medtec Europe 2017 Medtec Europe welcomes some of the biggest companies within the medical device industry and to help business continue to thrive, the organisers have been working on ways to enhance this process. This year visitors can take advantage of Medtec Meetings a free matchmaking tool that makes automatic matches based on business needs. The company simply activates an account and fill outs its prerequisites. The tool will automatically find matches for the company to help them communicate before, during and after the event.
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COVER STORY
Brain Waves P
hillips-Medisize and its Medicom Innovation Partner subsidiary show how strategic development of drug delivery Phillips-Medisize devices boosts the explains how to p h a r m a c e u t i c a l industry’s R&D improve R&D productivity, shortening productivity through development lead times intelligent drug delivery for intelligent connected drug delivery devices in line with increasingly rapid technology advances. It also means enhanced value for patients and all other stakeholders. Healthcare costs consume a steadily increasing share of national economies, rising in the USA from around 5% of gross domestic product in 1960 to almost 18% in 2014. The entire healthcare delivery system is under pricing pressure, with pharmaceutical companies under close scrutiny, even though prescription medicine only accounts for around 10% of overall health expenditure. The industry is beginning to focus on delivering positive outcomes for patients, justifying the costs of therapy compared with the existing standard. Costs continue to rise as pharmaceutical companies develop better products, often biologics which are targeted at more complex diseases (ie autoimmune disorders) and are more expensive to develop. That hasn’t pleased patients or medical insurers, who enjoy the benefits of progress, but don’t like higher costs. Shareholders would also prefer greater value from investments in pharmaceutical companies, in terms of dividend yields and long-term growth in share values.
Biopharmaceutical pricing pressure spurs demand for innovation Medicom’s executive VP Kevin Deane and PhillipsMedisize’s CTO Bill Welch believe that strategic development of drug delivery devices plays an important role in meeting price pressure by providing higher value solutions. Welch and Deane illustrate the urgent need for corrective action by referring to a Deloitte report: The return on R&D expenditure, (R&D productivity) among 12 leading pharma companies with products in late stage development has dropped from an average of 10.1% in 2010 to 3.7% in 2016. This is in part due to few new drugs reaching ‘blockbuster’ status with sales exceeding one billion USD, but also to treatments becoming more complex, 18
ABOVE | Integration lead times
and more expensive to develop. Biopharmaceutical companies compete to develop targeting what are often unfulfilled treatment needs, potentially dividing the available market. And pressure on R&D returns is even higher when payment is made only according to measurable outcomes. The way drugs are delivered to patients these days is increasingly made by complex delivery devices, as opposed to traditional tablets or capsules. Such simpler means accounted for nine out the top ten drugs delivered in 2005. But eight out of the top ten in 2015 involved delivery by injection. This shift involved a ten-fold increase in the value of drugs delivered by injection, while the overall value of the top ten drugs had increased by just 53%. Pointing to the increasing number of devices being connected online to reach 20 to 50 billion USD by 2020, Welch and Deane say that: “The healthcare industry, and specifically drug delivery, will inevitably be caught up in this societal change too”.
Maximum value Welch and Deane note that pharmaceutical company R&D departments can improve productivity by adopting a dual-track strategy. Ideally, this strategy should focus on both R&D efficiency, meaning development of more affordable drugs through less costly R&D, and R&D effectiveness, so that patients benefit from the greater value of more innovative drugs, along with higher quality information. They say pharmaceutical companies have, to date, focussed more on R&D efficiency, less on R&D effectiveness
for greater value. They cite consultants Deloitte as having established that pharma companies tend to become market leaders when they integrate value-adding strategies early in the R&D value chain, with these no longer being sole commercial or R&D function remits, but of both functions together.This results in better end-to-end decisions addressing all stakeholder needs, from payers through providers to patients. Leading companies take this approach along with a focus on development of high levels of expertise in particular therapy areas, also targeting populations for maximum value creation. Drug delivery devices play an increasing key role here with many new drugs being introduced ensuring more effective treatment and potentially reducing treatment documentation. Patient perception of a drug, and the pharmaceutical company providing it, depend on the delivery device, Welch and Deane maintain, as this can contribute towards better support of patients, care providers and other key care system stakeholders. Medicom, for example, is proud of the approach it takes to identify how specific delivery devices can support patients and obtain improved care results. Welch and Deane say maximum value is achieved by researching the market to find opportunities arising from unmet therapy needs, along with assessing the competitive position. Drug delivery device manufacturers can approach the market with differentiated rather than lower value “me too” solutions that replicate what others are already doing. Only then can plans be drawn up for launch and further development of identified high value therapy solutions in the market. These plans should allow for assessment of possible risks, constraints and uncertainties - on the
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COVER STORY
regulatory side, in the supply chain and in treatment opportunities. Allowance should also be made for assessment, for both the device manufacturer and users, of newer technologies for incorporation into the devices in the short or long term, including online “connected health” communication possibilities. Dealing with life cycle management becomes more important in a dynamic environment in which the pace of technological evolution increases, making some solutions less attractive in value, or even obsolete, as time passes. The process of strategy development should be completed within 2-3 months and evaluates existing feasible solutions as building blocks, supported by stakeholder interviews, user research and workshops with clients. Rapid prototyped delivery devices can be a useful tool to support device development, as well as in identification of further opportunities. Phillips-Medisize starts each development path with a strategy stage, consisting of consideration of market differentiation, market execution and constraints-to-execution phases. The product development stage starts in the last of these three phases. The manufacturing stage and its associated manufacturing design and development phase begin early during the product development stage, immediately allowing full-scale production. The company says this approach achieves shorter lead times than standard lead-time approaches, because of the inclusion of the strategy stage. A key element in shorter lead time to production is that all development team members are involved in the project, saving time transferring knowledge from one team member to another. Time is also saved by handling device development in parallel with development of technology platforms that provide technology needed for devices in development. According to Welch and Deane, pharmaceutical companies can better understand patient needs by considering drug delivery device strategies already at an early stage of commercial considerations in drug development, thereby gaining a better view of the potential value that can be added to care programs. Most pharmaceutical companies recognise the important role played by drug delivery devices, but they need to understand that R&D effectiveness is equally, if not more, important than R&D efficiency. Early planning of specific drug delivery devices for individual types of therapy “will often hold the key to unlocking greater value”.
Unlocking greater value in this way is how performance of medicines developed for each specific type of therapy can be improved, Welch and Deane maintain. As this creates better understanding of how the therapy works, there is a direct benefit for patients and the support they obtain from the various stakeholders. As this understanding grows, so does the potential for spinoffs into more differentiated products. Integration of drug and device development with manufacturing is the key holistic approach and the driver towards obtaining significant improvements in R&D productivity, Welch and Deane conclude.
Intelligent multiple sclerosis solution Medicom provides an injection delivery device to treat multiple sclerosis as an example of a product developed with the company’s drug delivery strategy approach for maximum added value. It has at its core the prevention of severe MS relapses as “a clear health economics driver”. It achieves this by improving “event-driven” patient interaction and information-sharing with healthcare professionals (HPCs) on specific MS therapy needs, that “off-the-shelf devices are simply not able to deliver”. Product features include visual and audible indicators, reducing the burden on patients to remember when to treat themselves, as well as to ensure full dose administration by reducing the risk of premature needle retraction. Patients can adjust needle injection speed and depth for optimal comfort. Ergonomic design in terms of the injection button position and use of a low-force safety release enables single-hand use and easy access to various injection sites. The needle is automatically inserted and retracted gently and smoothly by a motor, and as the needle is always hidden. These aspects lead to less anxiety during treatment. And finally, Bluetooth or USB connection to the MS drug delivery device provides an interface for automatic updates via a smart device app. http://phillipsmedisize.com/whitepapers
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THERMOFORMING
The shape of things to come
T
he sterile medical packaging market continues to grow, with research published by MarketsandMarkets Seán Egan, Nelipak projecting sales Healthcare Packaging, c o u l d i n c r e a s e examines the evolving by a Compound Annual Growth role of thermoforming Rate of 5.72% over suppliers in medical the next several packaging design years, bringing it to a $35.07 billion industry by 2020. Thermoforming represents one of the main manufacturing processes used in medical packaging production. Today’s medical device OEMs are looking to their thermoforming supplier to be more than just a manufacturer. Thermoformers become an extension of the customers’ packaging development team, taking on expanded roles in design, development and testing. Furthermore, OEMs expect thermoformers to not merely design around the product, but to fully understand how both the product and pack are to be used within the clinical environment. This increasingly results in device packaging not simply being a transport vehicle to get the device to the OR - but in many cases the pouch or tray may be used as part of the procedure. Team spirit: According to Seán Egan, Nelipak Healthcare, thermoformers are an extension of the customers’ packaging development team. Image: Nelipak Healthcare Packaging
Design for manufacturing is another important consideration for the thermoformer in the package design process; having a pack that ticks all the boxes for the customer is no use if the product is difficult to manufacture. Prediction tools allow designers and tool makers to understand how a part will behave during manufacturing and amend accordingly to maximize production runs. On the OEM side, automation is increasingly being introduced into the manufacturing setting; the design team needs to take account of the requirements of the process balanced with the needs of the end user. Thermoformers also need to understand how packaging influences the customers’ packing operations and supply chain. In addition to reducing the overall amount of plastic used, well-designed products have the ability to reduce labour and handling costs such as transportation, sterilisation and storage through the supply chain. Reduction in overall footprint of the end pack should also lead to less plastic finding its way into the waste stream in situations where recycling is not practical, such as hospital waste with risk of contamination. Thermoformers and OEMs also need to work together to determine which materials should be used for packaging. The decision behind material selection is based on the product which is being packed, the sterilisation method and material costs. Pricing can affect material choice if one or more materials can meet the same need for the pack, but where there is no alternative customers expect that package design will minimise the amount of material required to lower unit cost. In regards to packaging materials, healthcare device and pharma companies tend to be more conservative about change than other sectors of the market, largely due to the regulatory scrutiny they face. Healthcare rigid packaging predominately uses PETG,
APET, HIPs and Barex materials. OEMs will generally favour these packaging formats and materials already proven in the market, which can limit their ability to innovate for evolving market needs. But new packaging formats or material combinations require validation and preparation of documentation for submission, which is both time consuming and costly to carry out. New materials need to address a critical market need in order to get quick acceptance, otherwise penetration of the market can be slow. Choosing a thermoformer who is experienced in navigating these challenges can open the door to expanded possibilities for next generation packaging. A thermoformer also must have an intricate understanding of the factors which impact seal integrity, which is critical to the product efficacy of healthcare packaging, as the seal maintains necessary sterile barriers. Seals must always remain intact under the strains of shipping and handling, yet peel open quickly and easily for the enduser in a surgical environment. Understanding and applying best practices during the heat sealing process and using custom built cleanroom sealing machines designed to the specifications of a medical device, pharmaceutical thermoformed blisters, or trays can result in better quality products that consistently have the necessary seal strengths and properties. Over the next few years, new medical device technology will emerge where packaging will play an even bigger part in the functionality and use of the device and have a larger role in educating home users in the device’s proper use. Choosing a thermoforming partner with the expertise, technical capabilities and industry knowledge to add value at the design and development stages will be critical for OEMs looking to keep up with the needs of their end users and capitalise on the opportunities of the growing healthcare packaging market.
1 http://www.marketsandmarkets.com/Market-Reports/regulatory-environment-impact-analysis-sterile-packaging-market-133232063.html WWW.MEDICALPLASTICSNEWS.COM
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SPOTLIGHT ON INNOVATION
Leaders of the pack Innovation and medical plastic devices go hand in hand. Lu Rahman selects some of the sector’s stand-out companies.
I
t’s no secret that the medtech sector innovates with the best of them. As medical devices increase in functionality, as healthcare professionals demand more from medical products and as patients expect better usability and comfort, innovation does have to step up to the mark offering the above in a cost-effective, longlasting design. Innovating successfully requires knowledge. With expertise in the medical plastics sector, Clariant understands the role that innovation plays alongside product development. But device developers face a double challenge, the company’s Stephen Duckworth told MPN, in that they need to, “develop products that are functional, compliant and easy to manage for medical professionals in clinical settings, but they also need to keep consumers/patients in mind.” He added: “These users select and rely on these products to monitor health status, manage chronic conditions, and dispense medications at home, in the workplace, or on the go, and they want devices that are attractive and easy to use.” Creating these type of products requires in-depth know-how. Companies such as Clariant boast detailed knowledge of
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regulations plus an awareness of the need for materials to meet critical performance properties and at the same time meeting biocompatibility and toxicity standards. Beyond material selection and suitability, market knowledge – initiatives and legislation that will affect the on-going life of the product – is key. Product identification and anticounterfeiting are becoming increasingly important. Aware of this, Clariant recently teamed up with SICPA, a trusted provider of global security solutions. The two companies have launched the Plastiward system, which uses proprietary covert taggant additives (produced by SICPA) that are compounded into various polymers at one of Clariant’s ISO13485-certified plants. The taggants then become an integral part of the plastic product or packaging and are readily detectable using SICPA’s proven deployment and monitoring platform. Once the tagged product enters the supply stream, the SICPA monitoring system is able to identify them at any point from factory to pharmacy.
a reliable and inexpensive solution with its partners. It recognises that counterfeit products pose a threat to people and to a company’s brand image. To overcome this problem, Dr Patrick Blessing, head of Netstal’s Medical Technology and Precision Parts business unit told MPN that by “using smart tools, it is possible to add both visible and invisible markings to products during the injection moulding process”.
PDI’s Super Sani-Cloth wipes, a surface disinfectant used in healthcare to prevent healthcareassociated infections (HAIs). The study revealed that several of Sabic’s product technologies – including LEXAN EXL polycarbonate (PC) resin, XYLEX (PC/polyester blend) resin and VALOX polybutylene terephthalate (PBT) resin – deliver improved compatibility with PDI’s leading hospital-grade disinfectant.
Special devices can electronically detect markings invisible to the human eye – easily and inexpensively, said Netstal. For example, thanks to an integrated testing process, a laboratory machine can determine whether it has been stocked with original consumable materials or not. This also helps the work of customs agents to quickly identify counterfeit products.
Studies such as this are important for innovation to continue. “Sabic and PDI are committed to supporting the healthcare industry with information about compatibility between medical enclosure materials and commonly used disinfectants. Our joint study highlights the complex issue of environmental stress cracking, and provides valuable insights to help our customers make informed material selection decisions,” said Cathleen Hess, healthcare business leader for Sabic.
Stess test
Faking it
On-going material research helps advance the medical plastics sector. Last year Sabic’s and PDI announced the results of a joint study on the environmental stress cracking resistance (ESCR) of Sabic’s materials used for medical device enclosures.
Product counterfeiting is serious. Netstal has been looking at the problem and says it has devised
The two companies evaluated how well Sabic’s thermoplastics withstand repeated exposure to
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Press print The medical device sector watches closely the on-going research that helps drive the industry. Researchers from the Wyss Institute for Biologically Inspired Engineering at Harvard University and the Harvard John A. Paulson School of Engineering and Applied Sciences (SEAS) have
SPOTLIGHT ON INNOVATION
QOSINA’S INNOVATIVE YEAR For a business to be profitable or even survive, it has to be innovative. A company must keep up with technology, meet market requirements and implement more effective and efficient processes and services, while catering to customers’ needs. Qosina Corp, a global supplier of stock OEM components to the medical and pharmaceutical industries, recently made significant upgrades that it says will boost product lines, inventory operations and delivery solutions, as well as reducing its environmental footprint.
made the first entirely 3D-printed organ-on-a-chip with integrated sensing. Built by a fully automated, digital manufacturing procedure, the 3D-printed heart-on-a-chip can be fabricated with customisable size, shape and other physical properties, allowing researchers to easily collect reliable data for extended times in culture. This type of device offers potential for healthcare and may one day allow researchers to rapidly design organs-on-chips, also known as microphysiological systems, that match the properties of a specific disease or even an individual patient’s cells. “Our microfabrication approach opens new avenues for in vitro tissue engineering, toxicology and drug screening research,” said Kit Parker, professor of bioengineering and applied physics at SEAS.
Get your coat Many companies are continually looking at ways to improve the performance of medical devices. Jeff Hendricks Biotectix, explained how polymeric coatings can help do just that. Hendricks notes that one of the primary challenges facing next-generation cardiac and neuromodulation devices is electrode miniaturisation. Smaller electrodes are desirable to communicate with single neurons or small groups of cells, and to provide highly targeted stimulation in procedures such as deep
brain stimulation, for example, while avoiding the side effects of collateral stimulation. However, as the electrode size decreases its ability to transport charge also declines, leading to high interfacial impedance.
“
Clariant understands the role that innovation plays alongside product development.
”
Conducting polymers are an excellent material choice for miniaturised electrodes because they can safely deliver the necessary charge without damaging the tissue for stimulation and reduce noise for higher quality recording. Biotectix’s conducting polymer coatings offer the possibility to improve the safety and performance of existing medical devices and to enable electrode and device size reductions by reducing impedance. These materials can also be used to create custom textile-based electrodes for consumer wearable and medical monitoring devices. Furthermore, they can help reduce device cost, reduce device size, and have the potential to open up new capabilities for medical and consumer electronic devices.
Take the tube It’s always good to hear about the development of new devices. Cambridge Design Partnership (CDP) teamed up with King’s College London to develop a novel steerable catheter designed by King’s researchers. The catheter aims to improve the treatment of cardiac arrhythmia – a range of conditions which can lead to stroke or heart failure that affects 2 million people a year in the UK. The new steerable, micro-moulded catheter enables targeted delivery of radio frequency energy to specific points in the heart tissue for corrective treatment. Compared with traditional catheters, the device has been designed to be quicker and easier to manoeuvre into the correct position, improving the accuracy of positioning and minimising damage to healthy tissue, which should improve success rates of the treatment. Matt Brady, head of medical therapy, Cambridge Design Partnership, said: “The steerable catheter is an extraordinary product, with innovative features that enable corrective treatment to be delivered to very specific areas of the heart. By enabling greater accuracy and quicker treatment time, we believe it is possible to preserve more healthy heart tissue, and increase the success of the treatment. It’s been hugely exciting to be involved in this joint project with King’s College London and use our expertise to bring such an innovative product one step closer to commercial use.”
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New enteral connectors To improve patient safety, Qosina added a number of ENFit products to its inventory. This line of enteral feeding connectors meets the ISO 80369-3 standard, which has been developed by the International Organisation for Standardisation to reduce the risk of small-bore misconnections used in liquid and gas healthcare applications. ISO certification Because quality and safety are non-negotiable in the world of medical components, Qosina has gained ISO 13485 certification. This globally recognised standard specifies the requirements for a quality management system that can be used by organisations providing medical devices, components and delivery of related services. The company is also ISO 9001 and ISO 14001 certified. Larger facility Qosina recently moved its operations to a 95,000 squarefoot, climate-controlled facility with an ISO Class 8 cleanroom. The new building provides the infrastructure to house its medical components, and store inventory for just-in-time delivery to its customers. Paperless office system Last year Qosina became a paperless office. This not only reduced its environmental footprint and improved operational efficiencies but it also freed up storage space, allowing for better inventory management solutions for customers and providing justin-time delivery to meet specific production capacity.
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OVERSEAS MARKETS
What’s the name of the game? O
pportunities for Western companies to break into China have never been better and the country continues to offer opportunities for the medical device sector. Chinese consumers are spending more on Western goods than ever before. But As managing director something as simple as a name can make the difference to success or failure in of IDC UK and IDC all China.
China, Stephen Knowles has a solid understanding of product naming in China. He outlines some of the key considerations for companies entering this market
At IDC, our British and Chinese design studios work together to help global organisations choose suitable names for their Western products going into China. Many people don’t realise that there is quite an art to the naming process. Brand names in China are extremely significant to consumers; much more so than in the West. It could actually make or break a product and getting the right combination of brand meaning and pronunciation is a fine art when launching a product into Chinese markets. The most successful companies use a systematic process of research to benchmark competitors and use this knowledge to support strategic decisions about brand values and product lines.
What’s involved in naming a product for China? First of all there are the linguistic considerations – it’s not just a simple case of translating a word. Chinese characters can be interpreted in a number of different ways and there are many different dialects in China which can lead to misinterpretation. The two main forms of Chinese, Mandarin and Cantonese, can cause issues with pronunciation. In Hong Kong for example, it is Cantonese that is mainly spoken and as the first Chinese consumers to buy into luxury Western goods, meant that many older Western brands were named for a Cantonese audience. But with mainland China speaking mainly Mandarin, and quite striking differences in pronunciation between Mandarin and Cantonese, these brands are not always easy to pronounce for Mandarin speakers. With increasing demand for Western products in mainland China, products need to be named with Mandarin speakers in mind. There are also cultural implications of names, with certain things considered good or bad, based on traditions or religious beliefs. There are several different strategies when naming Western products for China, or a combination of these:
No translation - some manufacturers make a decision to keep English names or a combination of English and Chinese. Many medical companies opt to simplify the messages of their medical products by using a combination of English with product descriptions in Chinese, such as Medtronic’s neurostimulator PrimeAdvanced, which means nerve stimulation device. Phonetic translation - this is often used for English names with no or little associated meaning with the product. Chinese characters for translated names are often chosen to deliver the meaning of traits such as perfection, luck, and innovation. Hilton chose this route for its brand, which remains a foreign sounding name in China, but worked to its advantage as it is widely known across China for being luxurious. Meaning-based translation - If the name has heroic meaning or the meaning of the name conveys product features, this can be a useful type of translation. Reebok is interpreted as ‘fast steps’ and Nike as ‘endurance and perseverance’ – in both cases presenting a strong image of what the brands actually represent. Feature-based translation - This may be used when it is relatively hard to transliterate the English names to easilyreadable Chinese names. Feature-based translated names usually describe key features and main functions of the product. Many medical products take this approach. Value-based translation – This can be used to represent core values and morality of the company in relation to its products, and these names also imply the company’s caring attitude and responsibility for users. Healthcare giant Johnson and Johnson used this in its Chinese name, with characters that mean ‘strong vitality’.
Heroic Chinese words – These can sometimes be used to create a more emotional association with the products. The words are usually closely related to powerful cultural habits or religious traditions. BMW chose a name which has great emotional appeal. The Chinese characters include the sounds of the first two letters of their brand ‘BM’ which translate into ‘precious horse’. In China the horse is believed to be a sign of luck and prosperity and the same character for ‘horse’ also appears in the character for ‘motor’, so they were also able to develop a name that had appeal in many dimensions.
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OVERSEAS MARKETS
IDC’s Chinese naming process
Brainstorming for words & meaning
Before decisions can be made about naming, companies need to fully understand how to communicate their brand and express the benefits of their innovation. At IDC this is where a systematic process of research and linguistic analysis comes in. Our Shanghai team works closely with clients’ marketing departments to devise names which best represent the brand.
Once we have a clear direction for translation strategy, we start to brainstorm the most effective English words to communicate our brand values. Working hand-in-hand with our Shanghai team, we translate these words into Chinese characters and assess how they can be interpreted and pronounced in various Chinese dialects. We prepare a shortlist of words which are best suited for potential naming strategies, whether it be feature-based translation, phonetic and valuebased translation or any combination of the naming strategies discussed earlier. In all cases, we try to select Chinese characters that sound similar to the original English product name and usually use a maximum of three Chinese characters for the name, to suit the format of Chinese names. Once we have a shortlist of names, we check that there are internet domain names available for each potential product name.
Brand analysis The first stage of the process is to go back to basics and analyse what the brand represents. We look at the company, its values and understand where the product fits, now and in the future. Is it part of a family of products, are more planned and how will this affect the naming of future products? There is often quite a hierarchy to product naming in large organisations. Some products may carry name prefixes when in the same family or perhaps the company prefers products to have their own identity for other reasons. What are the core values that need to be communicated – is it cleanliness, accuracy, comfort, safety, innovation, luxury, quality or any number of other values?
Competitor research & benchmarking We research how competitors are naming their products in the market. What naming strategy have they chosen for translation and which products have been most successful? We gather information about how their product names communicate company and brand values, how well these have been translated, and patterns of product families. These competitors are then benchmarked to help support the decision making of our client’s product.
Focus group testing To help us decide which product name is best, we do further research by testing the names out with focus groups. This gives valuable feedback from real people who will potentially be buying or using the product. At this stage we can quickly identify which names are the most appealing and effective. The results of this research provides essential information to help the client make a final decision about the name of their product. As this article has shown, in all cases it’s wise to get the outside support of a consultant who understands the naming process in China. It’s not just a simple case of translation, there’s a whole systematic process of research involved and it’s essential to have local knowledge and an understanding of cultural and religious beliefs too, to maximise opportunities for a successful and enduring brand.
How are our top brands named in China? Western Brand
Chinese Name
Meaning of Name
Coca cola
Ke-kou ke-le
Tasty fun
Land Rover
Lu Hu
Land tiger (in China a tiger represents power and dignity)
Marriot
Wan Hao
Ten thousand tycoons (or an image of wealth)
IKEA
Yi Jia
Cosy home
Lego
Le Gao
Happy and tall
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MED-TECH INNOVATION
Let’s get down to business The UK and Irish medtech sectors are thriving. Visitors to the Med-Tech Innovation Expo, taking place at the Ricoh Arena on 26 and 27 April, will meet some of the sector’s leading players and experience an informative and thought-provoking conference and seminar stream. Lu Rahman explains why this is a must-visit event for the anyone involved in the industry
W
hile UK manufacturing as a whole may have experienced a decline in recent years, the country’s medtech market is bucking the trend. The sector boasts expertise in research and development, as well as supply chain and manufacturing, and is currently one of the largest sectors globally. According to Espicom Healthcare Intelligence, in 2016 the UK market alone was worth $10.1bn (£8.3bn). The Irish medtech sector is looking just as buoyant. According to the Irish Medtech Association the medical technology sector in the country is recognised as one of five emerging global hubs, boasting exports of €12.6bn. In recent years the UK life science sector has received a huge boost from the digital health sector. As we start to see increased demand from the UK’s National Health Service as the benefits of digital / connected devices to both patient and healthcare professional become apparent, this market is showing significant growth. And of course this is starting to impact on UK medtech. According to PwC the global sector for connected healthcare looks set to hit £37bn by 2020, with the UK on course to grab a 2% share of the market. On 26-27 April, the Med-Tech Innovation Expo, recently acquired by Rapid News Communications Group, will take place at the Ricoh Arena, Coventry. It is currently the only medtech manufacturing exhibition in the UK making it a must-visit event for packaging, electronics, medical plastics, design, sterilisation and manufacturing equipment and services. The expo will feature a two-day conference, stream of seminar events and the Medilink awards. This year’s event will also feature the Medtech Introducing stage where visitors will be able to listen to some of the UK and Ireland’s leading expertise in the medtech field.
Med-Tech Innovation Expo offers four events in one:
It’s the the only manufacturing exhibition in the UK to feature more than 130 companies covering packaging, medical electronics, medical plastics, design, sterilisation, components, manufacturing equipment & services
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It offers the free UK Med-Tech Innovation conference addressing the key trends, topics and challenges facing the industry.
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MED-TECH INNOVATION
Medtech Introducing programme
26 The event will unite a range of stakeholders involved in the medical device innovation process, showcasing 130 companies from the medical device supply chain. It has gained both popularity and support over recent years for both quality of exhibitors and stands. John Jeans CBE, adviser to the prime minister at the Office for Life Sciences said: “This sort of event brings people who are servicing the medical technology industry together and that’s very important both for the medical technology companies – the ones that then take the devices and components that we have seen here, forward into full scale medical devices.” Emma Raines, NPD technologist, Smith and Nephew also impressed: “The Med-Tech Innovation Expo was a great way to meet both new and current suppliers. In a world of online communication, it is always interesting to meet contacts from other companies for the first time. The EXPO was an excellent opportunity to gain an insight into exciting new technologies and devices, which broadened my understanding of the wound care device market. The seminars were also a great way to get in depth knowledge on highly useful topics. Cleanroom supplier NGS exhibited at the show in 2015. Sales director, Steve Gibson said: “We were extremely impressed at the professionalism of the event organisation and most importantly we were blown away by the quality of the visitors who attended our stand over the two days. Six months after the event we secured two large projects with companies we met there.”
11.30-12.00: IoT and healthcare – challenges and opportunities Dr Arash Ghadar, technical director, Datalink Electronics 12.00.12.30 UDI & laser marking medical devices: How vision technology is helping manufacturers Dr Faycal Benayad-Cherif, business manager software & vision 12.30-1300 Session 3 13.30-14.00 Effective industry an academic collaboration – a medical device case study Richard Hall, managing director, Pd-m Design Innovation & Pete Culmer, associate professor, University of Leeds 14.00-14.30 ISO 11607 and packaging validation throughout the product lifecycle Noel Gibbons, lead programme manager, Anecto 14.30-15.00 2C laser technology for the medical industry Carolin Grab, product manager, Trelleborg Sealing Solutions
It boasts the Medilink UK Healthcare Business Awards and Gala Dinner 2017 - a great networking and celebration opportunity.
27 10.30-11.15 A notified body’s perspective on changing the regulatory landscape – ISO 13485:2016 update Linda Moon, QMS specialist, medical devices BSI 11.15-11.30 A notified body’s perspective on changing the regulatory landscape – BSI services Damon Williams, development manager, medical devices BSI 11.30-12.00 A notified body’s perspective on changing the regulatory landscape – MDR update ad the effect on the supply chain Amie Smirthwaite, product specialist, medical devices, BSI 12.15-12.30 A notified body’s perspective on changing the regulatory landscape – PPE regulation update Nathan Shipley, certification team manager, PPE, BSI 13.30-14.00 Session 1 14.00-14.30 Session 2
There are free-to-attend specialist seminars covering critical design, innovation and manufacturing topics will be available to attend across the two-day event.
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ORTHOPAEDICS
Little things mean a lot Ambionics develops breakthrough child prosthetic using 3D printing
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tratasys’ PolyJet 3D printing technology has enabled Ben Ryan, founder of Ambionics, to create a fully-functioning 3D printed hydraulic prosthetic for his two year old son, Sol.
Sol was born with complications which resulted in the amputation of his lower left arm. Although able to keep approximately one inch of his lower arm, Sol would have to wait three years for a myoelectric prosthetic from the NHS in the UK, and one year before a cosmetic, non-functional prosthesis would be fitted. Ryan saw his son losing responsiveness and acceptance of his left arm, and decided to act. Carrying out research into infant development, Ryan saw that higher rejection rates occur when children are fit after the age of two years and that early fitting of functional devices correlates with continued prosthetic use throughout childhood. Another study also found that children fitted before two years of age tend to accept their powered prosthesis more than those fitted after two years. With this in mind, Ben designed a foam arm for his son and later a hydraulic prosthetic, enabling Sol to move his thumb on his own.
PRESS PRINT: Sol with his fully-functioning 3D printed hydraulic prosthetic arm, which enables him to move his thumb on his own
Researching infant development with prosthetics, Ryan has developed a prosthetic for infants to wear, enabling a more natural acceptance of prosthetic arms for young children. The customised design and production of the 3D printed hydraulic prosthetic has delivered cost savings of up to 76%, as well as time savings in design and production of 90%, compared with traditional methods of manufacture. This crucially permits prosthetics to be used at an earlier developmental stage.
Ryan designed and created his 3D printed hydraulic prosthetic arm on the Stratasys Connex 3D printer. First practicing with prototypes of his design, he 3D-printed flexible actuators and a power-splitting unit (double acting helical bellow or DAHB) for the prosthetic. He says that the DAHB unit enables the wearer to open and close the thumb in manual mode or with assistive power (using compressed air or a hydraulic pump and reservoir), but the grip continues to operate manually in the event of power interruption. “The success of my patented DAHB mechanism draws on the advanced capabilities of the Stratasys Connex Printer – the ability to combine rigid and soft materials in a single print was vital to the success of the design,” explains Ryan. “We were fortunate enough to have access to this technology, which enabled us to 3D print a prototype arm so quickly and cost-effectively. In founding Ambionics, it’s now my goal to ensure that other limb deficient children like my son are not faced with the current constraints and delays of traditional prosthetic manufacture.”
To develop the design for the prosthetic, Ryan used Autodesk Fusion 360. “This is a very innovative and ambitious project and it’s been inspiring to work on it,” says Paul Sohi, a product design expert at Autodesk. “It is amazing that despite Ryan having no real background in product design, he’s effectively taught himself enough to create something that will not only help his own son Sol, but in Ambionics, potentially others facing the same challenges too.” As well as its lightweight 3D printed design that weighs less than traditional myoelectric alternatives, the hydraulic prosthetic is body-powered and enables infants to grow accustomed to their ‘arm’ earlier than traditional fittings. The ability to operate without the need for any electronic devices or batteries is said to be unique to the Ambionics design and mitigates the risk of injury.
Scan to wearable prosthetic in five days While the NHS takes 11 weeks to convert the plaster cast of the arm into a wearable prosthetic, Ryan was able to produce the prosthetic in five days. With the flexibility to keep the scan on file, the digital copy allows replacement prosthetics to be easily produced through 3D printing. “Essentially the entire prosthetic is 3D printed,” Ryan adds. “Only Stratasys’ strong rubber-like and dissolvable support 3D printing materials make production and use of the DAHB units possible. The internal cavities are complex and it would be impossible to remove the support material using mechanical means. The materials must also be strong yet flexible as they are used to transmit fluid pressure to operate the grip.” Having patented its DAHB technology inside the prosthetic, Ambionics is aiming to offer the service to healthcare providers worldwide and has started a Crowdfunding campaign to enable medical device usability trials.
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PLASMA TECHNOLOGY
STICK IT OUT T
here is undoubtedly an incredible number of benefits that the use of plastics has brought to medical device manufacturers. Despite this, one Dyne Technology problem remains looks at the problems for medical device of adhesion that m a n u f a c t u r i n g medical device p r o f e s s i o n a l s – solving the problem manufacturers may of adhesion.
encounter
Many of the polymers used by medical device manufacturers such as polypropylene (PP), polyethylene (PE), cyclic olefin copolymer (COC), cyclic olefin polymer (COP) have low surface energies of between 29–36 dynes/cm (mN/m). This low surface energy effectively renders these materials ‘non-stick’ and achieving good adhesion is difficult at best but often impossible. Examples of this include printing inks rubbing off and glued parts failing. These problems of adhesion lead to the products produced by medical device manufacturers failing product quality and safety tests. No matter how much engineers clean or abrade the surface of these ‘nonstick’ polymers, they remain difficult to coat, print or bond to without resorting to harsh, environmentally damaging
chemicals or high temperature flame torch treatments.
It’s a gas: Vacuum plasma treatment of catheters
A controlled surface activation process Medical device manufacturers are rapidly moving towards plasma being the surface activation method of choice and plasma technology is increasingly being used throughout medical device manufacturing processes. The reason? Plasma treatment improves the adhesion properties of these ‘non-stick’ plastics and offers a controlled and verifiable process where all variables are managed. The process is easily calibrated, providing a consistent and reliable method of surface treatment and offers quality assurance, a vital pre-requisite when approving a new medical device manufacturing process. Plasma surface activation is ideal for a number of applications and comes in a range of verifiable units to suit a multitude of manufacturing processes. From catheter tubing and cannulas to optical coatings and care products, Dyne Technology’s engineers have experience implementing plasma technology into medical device manufacturing processes over a range of applications.
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SURFACE TREATMENT APPLICATIONS � � � � � �
Preparation before gluing Preparation before sealing Preparation before gasketing Surface cleaning of metal parts Surface activation prior to printing Surface activation to increase surface wetting
EXAMPLE COMPONENTS TREATED � � � � � � � � �
Tissue culture products Catheter tubing Cannulas Optical lenses Catheters Ostomy care products Wound care products Blood sampling devices And many more...
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PLASMA TECHNOLOGY
How does plasma treatment work? The strength of attraction between a material and a coating or adhesive is determined by the relative surface energy and surface tension of the materials. The higher the solid’s surface energy relative to the liquid’s surface tension the greater the molecular attraction, this draws the ink or adhesive closer for a higher bond strength. The lower the solid’s surface energy relative to the liquid’s surface tension, the weaker the attractive forces are which repels the coating or adhesive. Plasma treatment alters the molecular structure of a material’s surface to increase the surface energy of the material to the desired level. This increase in surface energy improves the chemical attraction to coatings, adhesives or printing inks, etc, leading to significantly improved surface wetting and adhesion strength. Dyne Technology engineers work in close partnership with medical plastics professionals exploring surface modification to measure the surface UK laboratory. By undertaking these tests, the appropriate treatment parameters are determined and ensure optimum treatment levels are achieved.
The plasma treatment process To appreciate the plasma treatment process, we must understand the surface properties required to obtain the ideal conditions for adhesion. It is widely accepted that there are seven gatekeepers you must pass to improve your chances of achieving good adhesion; your surface should be clean, dry, dust free, smooth, non-porous, wettable and polar. Having a clean, dry, dust free and non-porous surface is straightforward, whereas creating a surface that is also wettable and polar is a more complex matter. Exposing ‘non-stick’ plastics to the highly active environment of a plasma is an effective and long-lasting method of increasing the material’s polarity, wettability and surface energy. Plasma is generally described as a super ionised gas, or an electrically neutral medium of positive and negative particles and neutrals which can react with a wide range of materials. The term ‘ionised’ refers to the presence of free electrons which are not bound to an atom or a molecule. Plasma is created when a gas – in the case of surface treatment often air –is subjected to a high-energy discharge; the gas then breaks into electrons, ions, highly reactive free radicals short wave UV light photons and other excited particles. Put simply, when you subject atoms or molecules to enough energy, what happens very quickly is that the electrons around the nucleus start to ‘boil off’. The free radicals and other particles that exist in the highly active plasma discharge can attach to the material’s surface resulting in the formation of additional polar groups; these have a strong chemical
attraction to paints, coatings, sealants, inks and adhesives leading to significantly enhanced surface energy, polarity and therefore adhesion. It is important to note that plasma treating doesn’t alter the bulk properties of the material and the molecular alterations occur only on the material’s surface.
A dual treatment process Although not widely discussed, not only does plasma provide an easily verified, controlled process to effectively change the functionality of plastics, composites and rubbers; it also offers a green, solventfree method of removing organic contaminants from the surfaces of metals, ceramics, plastics and more. The plasma cleaning process is both clean and dry, cleanroom compatible and all equipment is easily calibrated to provide a consistent, verifiable and easily reproducible method of surface cleaning.
and flexibility required. The 3-axis bench top robot ensures accurate positioning of the atmospheric plasma treatment nozzle throughout the entire surface treatment cycle, guaranteeing a consistent plasma application. The cell is designed to allow the future integration of additional process equipment, giving the unit flexibility for any changes to Brandon Medical’s future manufacturing process.
The cleaning process occurs when plasma is created; as the gas (often air) that is used to create the plasma breaks up into a highlycharged mixture of particles, the excited species effectively scrub the surface clean.
“The production system installed has improved the adhesion of our coatings and therefore the overall quality, reliability and performance of our products,” said Nigel Davill, technical director, Brandon Medical
Practical applications: Atmospheric plasma
Vacuum plasma
Brandon Medical contacted Dyne Technology when looking for a solution to its adhesion problems. The companies worked closely together to analyse the problem and find an efficient and cost-effective solution.
Dyne Technology supplied a leading medical device manufacturer with the VacuTEC 2020 vacuum plasma unit. The customer faced adhesion problems involving an implantable polypropylene medical device. The ‘non-stick’ nature of the polypropylene made achieving adhesion impossible and the customer required a repeatable and reliable method of surface activation.
Following a series of tests, it became clear that the surface needed to be both cleaned and activated to allow the coating to fully wet the surface and achieve the high level of adhesion required. These test results combined with a detailed understanding of Brandon Medical’s manufacturing process led to the choice of the PlasmaTEC atmospheric plasma treatment unit as the solution. Atmospheric plasma devices can sometimes be referred to as air plasma, plasma jet or a plasma nozzle. The zone in front of a plasma nozzle is highly active and an excellent method of increasing the surface energy of plastics. Atmospheric plasma solutions are easily integrated with automation – an important pre-requisite for Brandon Medical. Employing a 3-axis bench top robot equipped with a PlasmaTEC atmospheric plasma treatment unit gave Brandon Medical the process control
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ABOVE | Point it out: Needle hubs following plasma treatment LEFT | Point in case: Syringes before and after plasma treatment
Following in-depth discussions and collaborative testing with Dyne Technology engineers, the high technology VacuTEC 2020 Vacuum Plasma unit was selected as the surface activation method of choice. Using a vacuum pump most of the air is removed from a sealed chamber. When the pressure in the plasma chamber reaches the required level the remaining air (or other gas) in the chamber is subjected to a strong electrical field, creating a plasma. This is used to modify the surface of the component. The unit has given the customer the ability to take charge of the plasma treating process allowing its engineers to have control over quality assurance.
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EXTRUSION
World vision The global healthcare sector is a key industry for Davis-Standard. The company describes its medical tubing technology for customers looking for expertise in this area
A
s the global medical tubing market has evolved, so has DavisStandard’s equipment offering and support services. Tight tolerances, high speeds, cleanroom specific equipment, process support and ongoing R&D services are paramount to DavisStandard’s medical tubing product line. According to the company laboratory lines at its headquarters in Pawcatuck, Connecticut and subsidiary in Suzhou, China, have helped customers bring new products to market, test new applications and refine processes for micro-bore catheter tubing, multi-lumen tubing and bump tubing. Medical tubing continues to be an area of significant growth for DavisStandard.
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We do everything possible to ensure our equipment meets or exceeds customer expectations - Kevin Dipollino
extruders and melt pumps with highly accurate servo drives to toggle between resins. “We do everything possible to ensure our equipment meets or exceeds customer expectations,” said Kevin Dipollino, product manager of Davis-Standard’s Pipe, Profile, & Tubing Systems. “With continued growth in medical tubing market worldwide, our R&D lab lines have been an extremely important asset for both Davis-Standard and our customers. The lines have also supported our efforts to stay ahead of the game and bring competitive solutions to the industry.”
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Examples of innovations include a tight tolerance medical tubing line for processing high temperature FEP (fluorinated ethylene propylene) tubing with radiopaque stripes, the MEDD (medical extruder direct drive) extruder and an alternating polymer tubing line. The FEP line is ideal for medical applications requiring biocompatibility and lubricity. The compact MEDD extruder is optimised for cleanroom environments with a replaceable feed section liner and direct drive technology for greater efficiency and materials flexibility.
Davis-Standard also offers a high-tech melt pump system to maximise stability when processing sensitive materials. The alternate polymer technology allows processors to switch from polymer A to polymer B by using precision
Davis-Standard’s principal medical lab is housed in a climate-controlled cleanroom environment at its R&D centre in Pawcatuck. Customers can test new resins, make parts for proof-of-concept, and conduct downstream R&D prior to making large capital equipment investments. The line is set up to run multiple resins. The lab also incorporates Davis-Standard’s patented Alternate Polymer technology with all components monitored and controlled by the EPIC III control system. Dr. Jason Baird, process development engineer added: “The healthcare segment is an important industry for us and extensive capabilities for cleanroom processing is a big part of that. Having multiple equipment options and a lab to test new processes is essential to serving our customers around the globe.”
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Quality in its purest form. With passion, we develop future-oriented inspection and sorting devices for quality assur assurance of plastics material that is amongst others used in sensitive areas such as the medical industry. The PURITY SCANNER is a so far unique solution, which combines X-ray technology with an optical inspection. A technology that ensures constant material quality and minimizes the risk of possible claims. – detects contamination of various kinds on the surface and inside the pellet by X-ray and optical cameras – purest material and highly qualitative end products due to automated sorting – for highest flexibility available with optical high-speed cameras as well as X-ray, color and infrared cameras depending on type of the expected contamination and application
www.sikora.net/purityscanner Visit us from June 13-15 at MD&M East, New York, NY
EXTRUSION
In a circular fashion Steve Maxson, Graham Engineering Corporation outlines the key processing and workplace safety considerations when extruding fluoropolymer medical tubing
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ecently Graham Engineering received a number of inquiries from medical tubing processors with an interest in venturing into the world of fluoropolymers. Materials such as FEP, PFA, PVDF and ETFE are known for their excellent physical properties and hold promise for many medical applications, such as micro tubing for intravenous (IV) catheters and insulin infusion, single lumen and multilumen tubing for endoscopy and cardiology devices, and heat shrink tubing used as a manufacturing aid for catheter reflow purposes. Our American Kuhne extrusion systems have been employed for such applications. Here are some important considerations that we have identified regarding extrusion equipment and safety related to processing fluoropolymers: Components that come in contact with molten resin such as the die head, tooling, adapter, breaker plate, and screw should be made of corrosion-resistant metals with high nickel content like Inconel 625 or Hastelloy C276. For corrosion protection of the extruder barrel, I recommend a tungsten carbide/nickelbased bimetallic barrel liner such as X800. For small medical extruders, 1.25-inch (32mm) and smaller, the entire backing material of the bimetallic barrel is solid Inconel and the liner material is X800. The typical fluoropolymer screw is a single-flight design with a 3:1 compression ratio. In some cases a lowshear Saxton-type distributive mixer is included at the end of the screw. Although Inconel and Hastelloy are corrosion resistant, these specialty metals have low torsional strength compared to common screws that are made of 4140 or
Materials such as FEP, PFA, PVDF and ETFE hold promise for applications such as micro tubing for intravenous (IV) catheters and insulin infusions
4340 heat-treated steel. For instance, Hastelloy 625 has a yield strength of approximately 52,000 psi (359 MPa), about half that of 4140 steel at 28-32 Rc. Inconel 625 is a little stronger than Hastelloy C276 but is not as corrosion resistant. Care must be taken to avoid screw breakage when using an Inconel or Hastelloy screw while processing other high temperature polymers that are not corrosive such as PEEK, Polysulfone (PSU), and Polyetherimide (PEI). For example, a 1-in. (25mm) extruder with a 5HP motor geared for 100RPM screw speed is very likely to snap a screw made from Hastelloy 625 during a cold start situation. Fluoropolymers have high melting points. For instance, PFA has a melting point at about 305 C (581 F). The barrel set points for FEP are in the 600-740 F range; therefore the extruder barrel heaters should be made from cast bronze and rated up to 480 C (900 F). Due to the high operating temperatures, a special dual-layer barrel safety shroud should be used over the barrel to protect the operator from burns. Fluoropolymers are also highly susceptible to melt fracture (‘shark skin’ appearance) on the surface of tubing, caused by excessive shear in the die tooling gaps as output rates are increased. The typical approach to avoiding melt fracture is to utilise larger tooling gaps, which means making the tubing with a larger drawdown. Tooling drawdowns of 3:1 to 20:1 are common for many polymers, whereas processors of fluoropolymers have used drawdowns of 50:1 or greater. Proper safety measures are important to consider when processing fluoropolymers. According to the Guide to the Safe Handling of Fluoropolymer Resins, published by the Fluoropolymers Division of the Plastics Industry Association (formerly SPI), gases, vapours and fumes released during the extrusion of fluoropolymers may be harmful to human health. Vapours and fumes released during extrusion and while cleaning the die head can cause flu-like symptoms (chills, headaches, fever) that typically pass within 24 to 48 hours. The corrosive gases should be captured immediately and removed with an exhaust ventilation system that includes extraction hoods, ducting, and a fan. Extraction hoods should be placed above the die head and, for large-diameter tubing, an additional extraction hood over the area where the tubing is cut to length. Sealed packages of fluoropolymer resins should only be opened in well ventilated areas. Consult the resin supplier’s MSDS for specific recommendations.
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Synecco is a global supplier of contract manufacture and design solutions for the medical device market
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• Packaging Design • Sterilisation Management • Sterilisation Validation • Kitting • Shelf-life Studies • Environment Testing • Palletisation/ Containerisation
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Synecco is the ideal solution provider for all your medtech manufacturing and supply needs. Fully accredited to ISO 13485 standard and U.S. FDA registered, Synecco offers medical device expertise from concept development to finished product supply.
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ELASTOMERICS
Forming an attachment Jane Powell, Techsil, explains how to choose the right adhesive when bonding elastomeric materials in medical devices
E
solvent resistance. They are not good gap fillers, have low temperature resistance, the bond skins quickly and may stress crack some plastics. In addition, cyanoacrylates do not allow time to re-align the joints due to curing in seconds and cannot extend over large areas (they will bond the spreader or roller).
lastomeric is a term given to materials that elastically return to their original shape after deformation by compression or tension. Materials fitting this category are numerous and include rubbers, plastics and polymers; all differ in their polymer structure, polarity, and surface properties and that is why it is so difficult to stick these materials together. The growing number of design applications for elastomeric substrates has greatly increased the need for information on assembly techniques using these materials. Adhesives offer several benefits over mechanical fasteners for joining elastomeric materials. Unlike solvent bonds or ultrasonic welds, adhesives perform well with thermoset rubbers. In addition, adhesives distribute stress over a joint’s entire bond area rather than in a single location. Unfortunately, the wide selection of elastomers and adhesives can make it difficult to identify the optimal combination for a given design.
RTV Silicone Adhesives: Solvent free, onepart systems which range in viscosity from self-leveling liquids to non-slumping pastes for gap filling. They cure to soft, flexible thermoset elastomers with excellent property retention over a wide temperature range. They adhere to a variety of substrates and there are UV cure formulations available to initiate cure. However, some can be slow to cure, so they are not always practical for small item assembly on a fast production line. They can have poor cohesive strength and a limited depth of cure.
What makes elastomeric materials so difficult to bond? Many modern elastomeric materials used in the medical field are formulated specifically for their resistance to harsh chemical and environmental conditions. As a result, these substrates also tend to be difficult to chemically bond. Often characterised by low surface energies, low porosity and non-polar surfaces, elastomeric materials feature no surface roughness onto which an adhesive can secure itself. In addition to this they are stretchy! So what properties are important to consider when choosing an adhesive to bond elastomeric materials? Must the adhesive provide an elastic bond once cured to prevent stress cracking? Does the adhesive need to withstand conventional sterilisation methods with no deterioration in the properties of the bond? If the bond will be in contact with water, heat or other environmental conditions will the adhesive be durable? Does the bond need to be invisible? Does the adhesive need to be viscous to fill a gap? How is the adhesive going to be applied; by
Strength in numbers: Two rubber substrates bonded with new UV adhesive Vitraliot VBB 2N LV show very high bond strength. Image courtesy of Panacol
hand or fast speed automated process? How big is the area to be bonded? Will the adhesive need to bond to other substrates? Does the adhesive need to have a particular bond strength, colour or cure speed? Although polyurethane, epoxy and hot-melt adhesives can be used; the main chemistries of adhesives for bonding elastomeric materials are: Cyanoacrylates: One-part, solvent free, rapid room temperature curing adhesives. They adhere to most substrates, are easy to dispense in automated systems and come in a range of viscosities. They exhibit strong shear and tensile strength. Whilst cyanoacrylates offer an easy bonding solution, they do have decisive drawbacks: They embrittle quickly and exhibit a very low impact and peel strength. They show poor durability on glass and poor WWW.MEDICALPLASTICSNEWS.COM
Light Curing Acrylics: Cure within seconds to form a tough thermoset polymer with excellent adhesion to a variety of substrates. The ability to cure ‘on demand’ offers significant processing benefits. In addition, the range of viscosities and properties make light curing acrylics ideally suited for fast speed automated bonding processes. Other advantages include: Good environmental resistance; solvent-free; good gap filling; 1-part; invisible bond lines; rapid fixture and complete cure; the bond formed is elastic, so there is no stress cracking and they can be sterilised without losing integrity. Drawbacks are minimal: light must be able to reach the bond line for cure and light source equipment must be purchased. Because the final resins are thermoset plastics, light curing acrylics offer enhanced thermal, chemical and environmental resistance over Cyanoacrylate adhesives. Selecting the best adhesive for a given application involves more than selecting the adhesive which provides the highest bond strength. Other factors such as speed of cure, flexibility, environmental resistance, thermal resistance, suitability for automation and price will play a large role in determining the optimum adhesive system for a given application.
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BIOABSORBABLE POLYMERS
Disappearing act “
According to Caitlyn Scaggs, Polymer Solutions, the changeability of bioabsorbable polymers is a double-edged sword
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BIOABSORBABLE POLYMERS
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hen it comes to bioabsorbable polymers, their ability to change, or degrade, is one of the stand-out characteristics that makes them the material of choice Caitlyn Scaggs, Polymer for medical device and Solutions discusses how drug delivery applications. to managing change However, like many things when deadline with in life, the changeability of bioabsorbable polymers is bioabsorbable polymers a double-edged sword. It creates tremendous benefits to patients when used to promote healing. However, when formulated improperly or if exposed to adverse conditions during the manufacturing process, they could fail when in-use.
Ideal material for medical devices Bioabsorable polymers are fascinating. They have the ability to degrade within the human body without adversely affecting living tissue. This makes them an ideal material for medical devices, implants, and drug delivery systems. These materials expedite healing without leaving behind a permanent medical device or materials, thus creating positive change without lasting negative consequences. Some common bioabsorbable polymers used within medical applications include polylactic acid (PLA), polyglycolide (PGA), polycaprolactone (PCL) and their copolymers.
Susceptible to temperature and moisture The very properties that make bioabsorbable materials so desirable for medical device and pharmaceutical applications are also the properties that make these materials sensitive during processing. Bioabsorbable polymers are susceptible to temperature and moisture differences, a vulnerability that helps them dissolve inside a patient. However, temperature and moisture conditions during processing can also prematurely degrade the materials, negatively affecting the material’s in-use performance. Specifically, moisture and heat can alter the molecular weight of the material, ultimately altering the mechanical properties. The end result is a degradation rate that is improper for the required application.
Life and death matter If a material degrades too soon proper healing may not occur. If a material takes too long to degrade a buildup of degradation products can occur, also threatening the patient’s health. The performance of bioabsorbable polymers in medical devices and implants is, quite often, literally a life-and-death matter. Device makers and material suppliers must carefully manage how their material or devices change in the human body.
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There is tremendous benefit to conducting surveillance testing or lot release testing, to proactively ensure materials and devices will perform as expected. Some of this testing is required by regulatory bodies but additional testing should be initiated, understanding that preventatively assessing problems reduces long term costs. Medical device recalls are costly and can produce irreversible negative PR. The reality of negatively impacting a patient’s well being is also a consequence that should be avoided at all costs, because that is the moral things to do. An array of testing methods can help us analyse bioabsorbable polymers throughout the full life cycle of the product, from raw materials to finished products and even explants as necessary. These relevant test methods include: Karl Fisher titration can determine
moisture content and identify moisture contamination.
Gel permeation chromatography/size
exclusion chromatography determines molecular weight of polymer samples.
Residual monomer analysis via
gas chromatography can identify potential toxicity issues caused by the presence of residual monomers.
Degradation and aging studies can aid in
understanding how long a bioabsorbable polymer may retain its integrity in patients’ bodies prior to degradation. Additionally, once degradation has begun the length of time required for the material to be partially and completely absorbed can be determined.
Nuclear magnetic resonance
spectroscopy analysis, can determine comonomer ratios.
Liquid chromatography/mass
spectrometry can be used for extractables and leachables testing. This ensures that during processing or while in packaging nothing dangerous migrates into the material.
Being able to manage and mitigate change is valuable across a number of areas of life, to include the use of bioabsorbable polymers. This can be accomplished by proactively assessing performance characteristics through a robust testing protocol. In doing so, manufacturers can be confident that these amazing materials will have a safe and positive impact on patients’ health and well being.
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TECH TALK
Smart move:
New system helps control polymer properties
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utomatic Continuous Online Monitoring of Polymerisation Reactions (ACOMP) is a smart manufacturing system that continuously and APMT explains how m o n i t o r s its ACOMP system c h a r a c t e r i s e s critical polymer provides real-time properties during monitoring, p o l y m e r i s a t i o n characterisation and reactions and postcontrol of polymer processing steps. The advantage properties for medical of continuously applications a n a l y s i n g the process in real time allows for faster and more precise control of production. If there is an issue in production and an adjustment is not made in a timely manner, the reaction may produce a polymer batch that is off-spec or unusable. Manufacturers of polymers for medical applications must adhere to stringent regulatory requirements as set forth by the FDA and other regulatory bodies. Due to these regulations, the admissible margin of error for critical polymer properties such as molecular weight, mass distribution and block copolymer composition is much smaller than that of polymers for other applications. ACOMP’s real-time analysis is a valuable tool for manufacturers of polymers because it allows the user to accurately predict and control reaction kinetics and polymer properties. For example, this real-time data enables more rapid adjustments to process temperature or reagent feeds. This capability can virtually eliminate the occurrence of offspec polymer and increase the efficiency of the process over time.
This article explains how ACOMP was used to successfully monitor the polymerisation of polyvinylpyrrolidone (PVP), a versatile polymer commonly used in excipients, contact lens solutions, dispersing agents and other medical applications.
Figure 1 shows the weight average molecular weight with respect to the polymer concentration for both reactions. As displayed in the figure below, the higher initiator concentration resulted in a 23% decrease in molecular weight.
Two PVP batch solution polymerisations were monitored with different initiator concentrations of 1.5% and 2.5%. This was done to exemplify how continuous monitoring and analysis by ACOMP can quickly and accurately identify the effect of a small change in initiator concentration on reaction kinetics and product quality as seen by the weight average molecular weight and intrinsic viscosity.
These differences in molecular weight propagation, as seen in Figure 1, resulted in a dispersity in the molecular weight distribution of 1.83 and 1.66 for the polymerisations at 1.5% and 2.5% respectively. This was measured using APMT’s chromatography-free molecular weight distribution analysis. These results are displayed below in Figure 2.
In this application, ACOMP uses ultraviolet absorption to monitor the concentration of monomer throughout the polymerisation. A single capillary viscometer was used to measure the intrinsic viscosity, and a 5-angle static light scattering detector was used to measure weight average molecular weight. The ACOMP system interfaced with the reactor through a recirculation loop ensuring a representative sample of the reactor contents was analysed. The reactor recirculation loop was continuously sampled at 0.5 ml/ min and diluted to the appropriate detector concentrations using ACOMP’s patented sampling, conditioning and data analysis technology. These fundamental techniques are suitable for other processes including bulk, emulsion and inverse emulsion polymerisations as well as post-processing steps like hydrolysis and quaternisation. As expected, the reaction with 2.5% initiator showed much faster kinetics. ACOMP also tracked the intrinsic viscosity as measured by the viscometer and shows that the higher initiator concentration produced a 10% decrease versus the 1.5% initiator concentration.
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Figure 1: PVP weight average molecular weight vs. polymer concentration
Figure 2: Chromatography-free MWD PVP Batch Reactions
In monitoring the polymerisation of PVP by ACOMP, the operator can easily identify and mitigate off-spec product much sooner in the event of an undesirable process condition as seen with a small change in initiator concentration. APMT has also used ACOMP in similar capacities to monitor and control polymerisation of other medical polymers including polyurethane, polymethyl methacrylate and polyacrylamide. ACOMP technology is also compatible for online monitoring of radius of gyration, molecular weight distribution, copolymer composition and monomer residual concentration.
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Five shows for medical plastics expertise... Medtec Europe. Over 1000 exhibitors will be at this event at Messe Stuttgart on 4-6 April 2017.
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Medtech Innovation Expo 2017, taking place on 26 and 27 April at the Ricoh Arena, Coventry, this is the UK’s only event aimed at manufacturing for the medtech sector
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MD&M East Now in its 34th year, the next event will take place at the Javit’s Convention Center, New York on 13-15 June.
Interplas The UK’s leading plastics event, Interplas will run from 26-28 September at the NEC, Birmingham, UK. This year the event will feature Mediplas@ Interplas focussing on medical manufacturing.
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Biomed Device San Hose Biomed Device San Jose is a two-day event on 6 and 7 December 2017 at the San Jose Convention Center in San Jose, USA. The show showcases emerging trends and innovations for the biomed sector.
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04:2017 Q: Where are the global hotspots for medtech? Cambridge Renowned for its academic excellence, Cambridge is also becoming known for its medtech expertise. In 2014, 670 start-ups companies made the city their home and it currently boasts the highest survival rate for new businesses outside of London at 49.4%. Ireland Medical devices and diagnostics currently account for around 8% of Ireland’s exports. The sector employs approximately 25,000 people which is the highest number of workers in the sector per capita in Europe. Manchester In recent years Manchester’s role in the Northern Powerhouse has made the area an attractive proposition for business particularly medtech. The region boasts a strong scientific heritage and has become increasingly popular with digital health start-ups. With a £6bn health and social care devolution deal on the horizon, the North West of England looks even more attractive for medtech innovation. California The Silicon Valley is known for its medtech excellence and the region is boosted by its rich academic heritage feeding new technology and innovation into the sector – look at some of the work coming out of Stanford University for example. With key names such as Medtronic making the area their home, its clear that the area has a strong future ahead of it.
SWEAT IT OUT:
New way to measure blood sugar A wearable patch for diabetics that can measure blood sugar with a small amount of sweat without drawing blood and administer drugs in stages according to the wearer’s levels, has been developed. The research team has been led by Kim Dae-hyung, professor of chemistry and biotechnology of the Nanoparticle Research Group which claims the system can measure blood sugar more accurately with less sweat than current diabetic patches.
The team states that the sugar sensor can measure blood sugar with around 1 microlitre (UL) of sweat, a volume which is less than a drop of water. The researchers also developed a strip-type sensor that allows the user to easily measure a single dose with the patch type sensor attached to the skin. They explain that a skin-tied glucose sensor can measure blood glucose levels and the strip-type glucose sensor can be used as a disposable product.
Check out... The new device being developed by Sheffield Teaching Hospitals NHS Foundation Trust and the University of Sheffield, which could help doctors reliably predict the risk of preterm birth. The device uses patented technology involving a method on impedance spectroscopy to pick up on changes to the composition and structure of cervical tissue. www.medicalplasticsnews.com/news/device-could-predictpreterm-birth-risk
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