MEDICAL PLASTICS news Leading the way Philips-Medisize explains what’s behind successful consumable diagnostics
+ TALKING HEADS – THE INDUSTRY’S MOVERS & SHAKERS REVEAL THE SECRETS OF THEIR SUCCESS
WHAT’S IN STORE AT COMPAMED & PHARMAPACK
ISSUE 33
Nov-Dec 2016
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Input Design Input Specification 3D files Drawings etc.
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Result Robust Design Cost efficient and robust manufacturing process
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CONTENTS Nov-Dec 2016, Issue 33
Regulars 5 Comment Lu Rahman and the exciting tech on offer at Compamed 7 News analysis 7 News focus SABIC and a study to protect patients from infection 8 Digital spy 10 News focus Wyss Institute and the first entirely 3D-printed organ-ona-chip 13 News focus What’s in store at Pharmapack and Compamed
20 Cover story Phillips-Medisize outlines successful consumable diagnostics
33 Cover lines Biotectix and Camstent look at some of the latest coatings innovation
46 Medtech at the movies
38 Meet the all-stars With the launch of MPN North American a few months away, Lu Rahman selects some of the region’s expertise
Features 18 Q&A IDC’s Stephen Knowles on the regulatory requirements for connected medical devices 22 Talking heads Some of medical plastics movers & shakers reveal what makes them tick 29 Sealed bids Rick Crane, J-Pac Medical looks at frangible and burst seal technology
41Taking shape Lu Rahman looks at what’s inspiring the 3D printing world, including origami 44 Close to the bone Martin Ganz, Micro Systems UK, explains why PEEK is growing in popularity for medical parts manufacture
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s we head towards Compamed and Medica it’s apparent that once again this showcase for the medtech and healthcare sectors won’t fail to disappoint. It’s a great time to be involved in the medtech sector and this year’s exhibition has some exciting technology to share with visitors. Innovation for the medical plastics device industry moves at a pace and this year’s event promises solutions for the medical device maker to improve manufacturing processes as well as the quality of devices destined for end use by the likes of you and me. As always 3D printing is a key technology for the sector and at this year’s event it looks like there’ll be some exciting developments on show. I’m also looking forward to seeing new trends in lab-on-achip, implants and soft robotics. Of course with our sister title Digital Health Age, I’m always keen to find out about the latest offerings in the digital health field and witness its positive effect on the device industry. Compamed and Medica are shouting about digital health this year – hardly surprising given the rate of uptake of this technology in healthcare systems across the world. The union between medical devices and digital technology is
unbelievably exciting. We’ve gone beyond the early days of wearable devices just tracking fitness. They are now monitoring health in a range of ways and have uses for adherence and prevention too. The use of smartphones has driven a host of healthcare technologies and mobile applications that can aid the health and well being of us all, The benefits of drug delivery in a home setting are well documented and the growth for this area of healthcare is encouraging for the longterm expansion of the industry. As the upward trend for the use of digital devices continues this of course has great potential for device manufacture.
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The union between medical devices and digital technology is unbelievably exciting.
According to Research and Markets, the “global market of digital health is up surging with a significant rate, due to increasing demand for advanced healthcare information system, and growing investments”. There’s no surprise that technology is leading the way in medtech. As healthcare sectors recognise the need to streamline processes and offer patients improved care and outcomes, digital health is the answer. This is fantastic news for the medical device sector. It’s a sector where technology excites. I’m looking forward to finding out what’s next in the technological pipeline.
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SABIC in study to help PROTECT PATIENTS FROM INFECTION
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ABIC and PDI have announced the results of a joint study on the environmental stress cracking resistance (ESCR) of SABIC’s materials used for medical device enclosures.
The two companies evaluated how well SABIC’s thermoplastics SABIC and PDI withstand repeated team up on study for exposure to PDI’s Super Sani-Cloth medical plastics to wipes, a surface help protect patients disinfectant widely from infection used in the healthcare environment to help 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. These and other products in SABIC’s portfolio of chemically resistant healthcare materials give manufacturers new options for designing medical equipment that maintains outstanding performance, while also addressing the disinfection demands of today’s healthcare environment. PDI and SABIC collaborated to establish a testing procedure following ASTM D543 guidelines and say they applied more stringent compatibility criteria compared with other benchmarks often used in the industry. SABIC has published the study findings in its updated and expanded brochure, Resistance + Durability: Chemical Resistance Performance Testing for Healthcare Materials. Also featured
in the brochure is a new section, Designing for ESCR, which describes why following best practices in injection moulding processing and designs can be instrumental in reducing moulded-in stress, a key contributor to ESCR performance. “Combatting HAIs is greatly important for hospitals, but if materials are not appropriately selected for the healthcare environment, the frequent application of cleaning chemicals can cause device enclosures to crack prematurely, which can lead to increased maintenance costs for healthcare providers,” said Cathleen Hess, healthcare business leader for SABIC. “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.” According to the Centers for Disease Control and Prevention (CDC): “Although significant progress has been made in preventing some infection types, there is much more work to be done. On any given day, about one in 25 hospital patients has at least one healthcare-associated infection.” The World Health Organization (WHO) reported that “hundreds of millions of patients are affected by health care-associated infections worldwide each year, leading to significant mortality and financial losses for health systems.”
“With heightened emphasis on infection control in healthcare environments, medical devices are regularly subjected to repeated contact with hospital-grade disinfectants and, as a result, require exceptionally strong materials that are less vulnerable to environmental stress cracking,” said Cheryl Moran, senior director of portfolio management, PDI Infection Prevention. “By guiding manufacturers towards plastics that are better suited for the specific disinfecting requirements of each medical device, our study benefits both medical device manufacturers and healthcare providers, ultimately benefiting the patient, who can be protected from potential adverse events resulting from damaged or improperly disinfected equipment. Continuing our collaboration with SABIC and medical equipment manufacturers will enable even further insights as additional technologies emerge.” Evaluating ESCR environmental stress cracking calls for in-depth knowledge of disinfectant and polymer chemistries and their compatibility, as well as part design and moulding considerations. It is influenced by each aspect of the application development process, including, but not limited to, polymer morphology, chemical type and concentration, frequency of cleaning and residual stress in moulded components. The SABIC/PDI study evaluated the compatibility of select SABIC materials with PDI’s wipes containing an alcohol/ quaternary ammonium compound (QAC)-based disinfectant. This intermediate-level disinfectant provides broad-spectrum efficacy with a twominute contact time.
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DIGITAL
DEVICE UPDATE
spy
Fighting talk EVERY SECOND MEDTECH COMPANY INVOLVED IN A PRICE WAR
BREAKTHROUGH
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GOOD ENOUGH TO EAT: Edible battery has potential for powering medical devices
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hristopher Bettinger, Carnegie Mellon University is developing an edible battery made with melanin and dissolvable materials. At a press conference organised by the American Chemical Society, Bettinger discussed polymers as they apply to batteries for ingestible medical devices. It’s a far cry from the advice we’ve been given outlining how dangerous batteries are if ingested but these are a different type of product altogether and may one day aid diagnosis and treatment. Made with melanin pigments which is naturally found in skin, hair and eyes, this substance protects the body from damage by absorbing UV light to see off free radicals. Covering the story, Science Daily wrote: “While he doesn’t have to worry about longevity, toxicity is an issue. To minimise the potential harm of future ingestible
devices, Bettinger’s team at Carnegie Mellon University (CMU) decided to turn to melanins and other naturally occurring compounds. In our skin, hair and eyes, melanins absorb ultraviolet light to quench free radicals and protect us from damage. They also happen to bind and unbind metallic ions.” Recognising this as a type of battery Bettinger and his researchers “experimented with battery designs that use melanin pigments at either the positive or negative terminals; various electrode materials such as manganese oxide and sodium titanium phosphate; and cations such as copper and iron that the body uses for normal functioning”. Compared with lithium-ion batteries, the capacity of Bettinger’s batteries are low. However, they would be strong enough to drive a biomedical device such as an ingestible drug delivery device.
Nine out of ten medtech companies are worried about rising price pressure and half of the industry players say they are actively engaged in a price war. These are the key findings of a medtech-specific industry analysis from the Global Pricing Study 2016, conducted the international strategy and marketing consultancy SimonKucher & Partners. Approximately 2,200 managers in leading positions from more than 40 countries and across all major industries participated in this year’s study, including approximately 100 participants from the medtech industry.
Global Pricing Study’s top 12% of medtech companies say investing in price management has put them in a much better position than their competitors. Their profits are up to 40% higher than the rest. That’s almost 50% higher profit than the average of all other industries. “These numbers underline the strong impact of efficient price management and the huge potential it holds,” explains Carlos Meca, director at Simon-Kucher.
The growing competition with lowcost providers (52%), increase in professional procurement processes (47%), and clients’ stronger negotiation power (44%) are the most important reasons for price pressure mentioned by medtech players. The result? Only
MATERIAL UPDATE
SuperNO2VA heights: Oxygen mask uses medical TPE for cushioned seal to face
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MD’s new SuperNO2VA mask, with Medalist TPE Seal from Teknor Apex, has been designed for sedation applications, including intra-oral surgeries that whole-face masks obstruct Relying on the sealing and cushioning capabilities of a supersoft thermoplastic elastomer (TPE), one company has addressed a longstanding problem in procedures involving sedation by creating what’s said to be the first nasal-only alternative to the standard full-face oxygenation and ventilation masks that medical practitioners have used for decades. Unlike full-face masks, the patentpending SuperNO2VA mask developed by Revolutionary Medical Devices (RMD) provides easy access to the oral cavity and is designed to deliver a greater flow of oxygen under positive pressure to the patient’s airways. The single-
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five out of ten companies state they have managed to increase their margins compared with the previous year.
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use mask consists of a transparent rigid polypropylene (PP) component with access ports for an anaesthesia circuit or hyperinflation bag, plus a TPE cushion that is over-moulded onto the PP structure. The TPE cushion, moulded of Medalist MD10105 medical elastomer from Teknor Apex Company sufficient ‘tack’ and is designed to form a tight seal on the patient’s face.
DIGITAL SPY
DIGITAL NEWS
MPN hits North America 2017 will see the launch of Medical Plastics News North America. Just like the European edition, this new sister title will feature the latest trends and advances in the medical plastics sector and will present the market’s news, thoughts and innovative practices to keep readers at the forefront of an industry that’s crucial to advancing healthcare internationally. Lu Rahman group editor, said: “The current MPN has always maintained a strong connection with its US audience and we’ve noticed that over recent years, this section of our readership is growing making the time right to offer a dedicated publication for this forward-looking region. Just like the original mag, out new US-focussed title will
provide a multi-platform hub for anyone working or targeting this sector. It will be a place to discuss, promote and learn – just like it’s UK counterpart. And with the same quality of readers – senior decision-makers from some of the world’s most influential medical devices OEMS, it will provide increased opportunities for both readers and advertise to reach and communicate with the wider medical device market.
talking
POINT
“We wouldn’t be doing our job if we didn’t keep on top of these trends and failed to reflect their importance to our audience – hence MPN North America. We’re very excited here and we hope you share that enthusiasm as we plan our first issue which will be with you early next year.”
BLOOMIN’ MARVELLOUS Scientists have created a polymer flower that can bloom thanks to an internal clock and may have uses in medtech
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DIGITAL SPY
Tinkled pink:
TickleFlex diabetic device wins prize
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eter Bailey’s TickleFlex has scooped a share of 200,000 as one of the Design Council Spark’s 2016 finalists. Bailey’s device is designed to improve the everyday lives of insulin-dependent diabetics by removing the human error and pain of injecting insulin. A Type 1 diabetic himself, Bailey’s device clips on
to the needle and works by creating a pinch that concentrates the subcutaneous tissue, controls the needle depth, and saturates local sensory inputs which then block the pain pathways. The specially textured flexing fingers grip the skin and fold inwards, like a multiple-fingered pinch, resulting in a safer and more comfortable way of self-administering.
Really? A plastic flower that blooms? Yes. Scientists at the University of North Carolina at Chapel Hill have played around with the molecular structure of a soft polymer to create a material that can be set to change shape eg bloom. Are you sure? Definitely. It does sound incredible. You’d be forgiven for mistaking the Guardian write up for a Wordsworth musing “The delicate flower bud bursts into life, opening layer after layer of brightly coloured petals, first large and red, then small and purple, and finally the innermost ones - tiny and orange. But as convincing as the bloom may seem, it is not a work of nature. Scientists created the flowering bud after learning how to make polymer sheets that can be programmed to change shape over time.” How’s this possible? Polymers have molecules that lie next to each other and which can move past each other. This is what makes the material flexible. As some of the links between the molecules in a polymer are permanent, the material can stretch and return to its original shape. The researchers discovered that they could change the materials ‘moving’ properties allowing it to shape shift over a period of time. So what’s the deal for the medtech sector? It has far-reaching benefits for the medtech sector . According to the New Scientist: “To demonstrate the concept, the team used the material to create a delivery box which opened automatically on one side when it reached its destination. But the morphing polymer is likely to be more useful for designing medical implants that are folded up for insertion then change shape inside the body.” And according to Michael Kessler, Washington State University in Pullman, who also develops transformable materials, this technology has “great potential for a range of applications, especially in biomedical engineering”.
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First entirely 3D-printed organ-on-a-chip
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WITH INTEGRATED SENSORS
esearchers 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 made the first entirely 3D-printed organ-on-a-chip paves the with integrated sensing.
Technique way for more complex, customisable devices, says Wyss Institute
Built by a fully automated, digital manufacturing procedure, the 3D-printed heart-on-a-chip can be quickly fabricated with customisable size, shape and other physical properties, allowing researchers reliable date to be easily collected for short-term and long-term studies. The study is published in Nature Materials. This new approach to manufacturing 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. “This new programmable approach to building organs-onchips not only allows us to easily change and customise the design of the system by integrating sensing but also drastically simplifies data acquisition,” said Johan Ulrik Lind, first author of the paper and postdoctoral fellow at SEAS and the Wyss Institute. “Our microfabrication approach opens new avenues for in vitro tissue engineering, toxicology and drug screening research,” said Kit Parker, senior coauthor of the study, professor of bioengineering and applied physics at SEAS. Organs-on-chips mimic the structure and function of native tissue and have emerged as a promising alternative to traditional animal testing. Wyss Institute research teams led by Parker and Wyss founding director and core faculty member Donald Ingber, have developed microphysiological systems that mimic the microarchitecture and functions of lungs, hearts, tongues and intestines. However, the fabrication and data collection process for organs-on-chips is expensive and laborious. Currently, these devices are built in clean rooms using a complex, multi-step lithographic process and collecting data requires microscopy or high-speed cameras.
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“Our approach was to address these two challenges simultaneously via digital manufacturing,” said Travis Busbee, coauthor of the paper and graduate student at Wyss and SEAS. “By developing new printable inks for multi-material 3D printing, we were able to automate the fabrication process while increasing the complexity of the devices.” The researchers developed six different inks that integrated soft strain sensors within the microarchitecture of the tissue. In a single, continuous procedure, the team 3D printed those materials into a cardiac microphysiological device - a heart on a chip - with integrated sensors. “We are pushing the boundaries of three-dimensional printing by developing and integrating multiple functional materials within printed devices,” said Jennifer Lewis, Hansjorg Wyss professor of biologically inspired engineering at SEAS, and senior coauthor of the study. “This study is a powerful demonstration of how our platform can be used to create fully functional, instrumented chips for drug screening and disease modelling.” The chip contains multiple wells, each with separate tissues and integrated sensors, allowing researchers to study many engineered cardiac tissues at once. To demonstrate the efficacy of the device, the team performed drug studies and longer-term studies of gradual changes in the contractile stress of engineered cardiac tissues, which can occur over the course of several weeks. “Researchers are often left working in the dark when it comes to gradual changes that occur during cardiac tissue development and maturation because there has been a lack of easy, non-invasive ways to measure the tissue functional performance,” said Lind. “These integrated sensors allow researchers to continuously collect data while tissues mature and improve their contractility. Similarly, they will enable studies of gradual effects of chronic exposure to toxins.” “Translating microphysiological devices into truly valuable platforms for studying human health and disease requires that we address both data acquisition and manufacturing of our devices,” said Parker. “This work offers new potential solutions to both of these central challenges.”
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French dressing P
harmapack Europe is a two-day exhibition and conference dedicated to pharmaceutical packaging and drug delivery. It takes place on 1 and 2 February 2017 at Paris Expo Porte de Versailles, Paris.
2017 marks 20 years of the pharma packaging and drug delivery event. The event once again offers the opportunity to meet leading suppliers and discover what’s new in the industry
2017 marks the event’s 20th successful year. It has grown in size, profile and popularity from a bi-annual event to a major annual show that attracts 5,100+ visitors and over 380 exhibitors from more than 70 countries around the world.
Attendees and delegates range from CEOs and CMCs to pharmacists and business execs, working in R&D and drug development to purchasing, engineering, marketing, logistics and business development. Innovation is at the heart of Pharmapack. An innovation gallery showcases selected industry innovations from exhibitors, while innovation tours guided by industry experts take visitors on a tour to exhibitors’ stands. The newest addition for 2017, the Pharmapack Start-up Hub, is designed to let innovative young pharma firms benefit from valuable networking and learning opportunities at a price that suits their budget. This dedicated area on the show floor gives them a platform to showcase their ideas, meet potential customers, partners and investors and forge new relationships that will help them develop for years to come.
The Pharmapack Awards recognise new products that are set to shape the future of the industry, in two categories. The exhibitor innovations category is dedicated to Pharmapack exhibitors who have developed a new product. For those who are not exhibiting, there is the health product category. This latter category distinguishes the packaging of new health products introduced to the market or the improvement of the packaging of an existing health product (for human or veterinary use). Both awards recognise products that have contributed to the proper use of medication, increased patient/user safety and compliance or represent a significant step towards sustainable packaging. Pharmapack is an opportunity to sharpen up technical and industry knowledge. Its content programme comprises two days of conferences, a one-day serialisation, track and trace symposium, a day of workshops and a learning lab that hosts short, sharp presentations on key topics from exhibitors throughout the two show days.
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Why digital health will be big news at Compamed
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ompamed hit a record-breaking 18,800 visitors last year. Many product developers, production managers purchasing Klaus Jopp looks a n d are at the growing decision-makers again expected at this trend for digital year’s event in Halls 8a products within and 8b. Visitors have the healthcare the opportunity to attend High-Tech Forum, sector at this year’s the which will feature a Compamed on session on wearable 14-17 November electronics and the Suppliers Forum which among other things will look at the ‘Benefits and challenges of 3D printing’ and ‘Industry 4.0 and medical technology: New business models for manufacturers’.
Market trends – digital health “Digitisation presents great opportunities for the healthcare sector in an increasingly ageing society in which a growing number people suffer from chronic illnesses. Digitisation can help diseases to be detected earlier, the duration of hospital stays to be reduced and people’s mobility to be extended with the aid of telemedicine, apps or care robots,” writes the German Medical Association BVMed. The healthcare and medtech industries are talking more and more about digitisation, the Internet of Things and Industry 4.0. New developments in digital technology will be shaping Compamed 2016 in Düsseldorf. With more than 750 exhibitors, this platform for suppliers to the medical-
technology industry will this year be celebrating its 25th anniversary and will be taking place alongside the medical trade fair, Medica. The IVAM Microtechnology Network, which represents small and mediumsized businesses, notes: “A trend that we are currently seeing is digitisation. Mobile health applications, the Internet of Things, wearables and smart implants and textiles are playing an increasingly significant role in the product market that IVAM serves. That is why we once again want to give manufacturers of such miniaturised electronic components as sensors and actuators strong representation at our joint IVAM stand,” says Mona Okroy-Hellweg, IVAM spokesperson. The network will be hosting around 50 companies at its joint stand at Compamed. “Advancing digitisation in the healthcare sector is currently also shaping activities in the development of medical products,” confirms Joachim Schäfer, CEO at Messe Düsseldorf.
then transfer them via the intranet or internet. This will make it possible to record the progress of patients’ well-being in different environments. The captured data will enable the creation and delivery of services via the intranet or internet and provide recommendations for action, eg to take some exercise or medicine. They will also detect which measures helped improve the health condition. This would, for example, allow a service generated from the collected health data to assess the success of interventions on the basis of medical criteria (guidelines) and so provide the best possible therapy.
Interoperable sensors and actuators
“Such services would use interoperable interfaces to connect the various manufacturerindependent components and devices to smart mobile devices. In the next stage, performance-assessment software would continuously analyse the progress of measures and improve the healthcare that is being provided,” explains Johannes Dehm, standardisation expert for medical technology at the VDE, outlining possible future scenarios.
The newly formed Information Technology Society (ITG) within the VDE, the German Association for Electrical, Electronic & Information Technologies, expects that ‘useroriented, secure, dynamic systems in the healthcare sector’ will in future use interoperable sensors and actuators on patients to capture and digitise data relating to parameters such as weight, blood pressure, temperature, activity and ECGs and
The transformation of different types of data generated by sensors and actuators would, in compliance with the telematics infrastructure (data security), allow these systems to inform all involved along the healthcare chain about important parameters – in almost real time. This scenario would allow many developments and products to be derived for the companies exhibiting at Compamed.
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Hall 8a Stand S19
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One in three Germans uses a health app Without a doubt, mobile applications that deliver health services through mobile communications devices are on the rise. Health apps are becoming more and more popular. There are around 100,000 apps alone in the narrower field of healthcare that are also being marketed by medicaltechnology companies. Almost half a million products are available through app stores, the number of downloads exceeded the 3 billion mark in 2015 – a figure that has doubled in just two years. A survey by the Bertelsmann Foundation found that 30% of people in Germany have already installed health apps on their smartphones. The BVMed has found that they are used for improving health competence, providing analyses, gaining new findings and awareness, indirect interventions through the continuous recording and analysis of healthrelated information, on-line courses, the documentation of health and illness histories, the organisation and management of processes as well as the purchase and delivery through online pharmacies. Said to be the world’s smallest differential pressure sensor – which Sensirion will be presenting at Compamed – should be ideally suited for mobile applications, particularly in the field of respiration. The digital component’s size of 5 x 8 x 5mm will allow it to be installed in devices which previously did not have the space for sensors. The small sensor will also make it possible to significantly reduce the size of existing devices.
3D printing and medtech 3D printing is a key technology in the medtech sector and once again will feature highly at Compamed, particularly in the Suppliers Forum. The LightFlex research project, for instance, which is being carried out by the Fraunhofer Institute for Production Technology (IPT) in cooperation with a variety of industrial partners, is an example of how the process is changing the field. It is aimed at manufacturing medical prostheses using a combination of 3D printing and fibre-composite technologies.
Fibre-reinforced injection moulded components do have one disadvantage – it is difficult to adapt them to individual appications and they have to be produced in large quantities as the corresponding tools are expensive and inflexible. This is why injection-moulded components are increasingly being replaced by ones produced using additive manufacturing – 3D printing makes it possible to individualise and functionalise almost any component before it is combined with a thermoplastic fibre-composite plastic to help it achieve the required loadbearing capacities. Since 2004, the market for additive manufacturing has been growing by around 20% per year (source: Wohlers Report 2016) – this growth is expected to continue.
International growth market: Flow cytometry The international market for flow cytometry has grown by more than 10% a year over the last five years. The latest forecasts (eg by Acute Market Reports) estimate that market volumes will continue to expand and will reach values of 5billion by the year 2020. This growth is being driven by the increasing demand for single-cell analyses – for instance in personalised cancer therapy. ‘Liquid biopsies’ currently represent a promising approach for diagnostics, monitoring and individualised therapy in the field of cancer treatment. This type of biopsy permits cancerassociated biomarkers to be detected in conventional blood samples. These include freely circulating tumour cells (CTCs), circulating tumour DNA (ctDNA) and exosomes. The subsequent ‘Next Generation Sequencing’ and sequence analyses of the biomarkers’ nucleic acids will then as a consequence permit individualised therapy measures. It is against this backdrop that the Fraunhofer Institute for Chemical Technology – Institute for Microtechnology Mainz (ITC-IMM), which is working within the Ci3 lead cluster, has developed the CTCelect device for extracting single tumour cells from
full blood and storing them in the wells of mictrotiter plates. The device spans the arc between sampling and singlecell analysis, achieving very high target-cell yields (> 75%) and very high target-cell purities. Automation allows great reproducibility to be achieved, which initially will be ideal for tumour research and then later for use in therapy management within the framework of personalised medicine. In 2014, the ICT-IMM was able to positively validate all the significant components within the CTCelect system so that system integration could then follow in 2015. “The CTCelect system, our platform technology for processing and analysing samples within the scope of liquid biopsies will be the highlight among our exhibits at this year’s Compamed,” explains Dr Michael Baßler, who is responsible for the system at the ITC-IMM.
Ultra-short pulse lasers Light as a tool remains an ongoing topic of interest at Compamed. Micreon, is a contract manufacturer for microprocessing using ultrashort pulse lasers that operate in the picosecond and femtosecond ranges. Working with these types of laser permits processing qualities to be achieved that are significantly higher than those that can be realised with conventional laser technologies. “Our laser technology has the advantage that it reaches precisions of one micrometre and hardly damages any of the solid materials it is used on at all,” explains Dr Frank Korte, CEO and head of research and development at Micreon. Ultra-short pulse lasers are characterised by the fact that the energy is concentrated locally in the solid material to such an extent that it is possible to directly ionise it without damaging the surrounding areas. Micreon has focused its laser micro-machining processes on precision cutting, micro grilling and structuring. The quality of the cut edges and insignificant damage to the component material are just two aspects that deliver great benefits to the production of stents made from biopolymers.
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Q&A
PLAYING BY THE RULES IDC’s MD, Stephen Knowles, advises about the regulatory requirements for connected medical devices There is a lot of interest in connected medical devices. Could you explain the regulatory process for connected medical devices with data transmission?
SK: The important thing is to always understand what you are measuring and how accurately you can measure it. So making sure the usability of the device is good, making sure the data is accurate and the user is using it correctly are fundamental first points. There is no point in transmitting data to a doctor or healthcare company if it isn’t accurate.
Testing times:
Q&A
According to IDC’s Stephen Knowles, understanding how to test and verify a device needs to be considered at an early stage
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One of the big things you have to decide when you develop the medical device is what you are going to do with the data. If you are monitoring a heart rate remotely are you able to use the data to get help if the device detects an emergency? Or is the device monitoring long term to see how the patient progresses and the data is purely for monitoring to see if the patient is improving? In each situation, if you want to make a medical decision on the basis of the data you have to be sure the medical device is complying to standards, is accurate and patients know how to use it properly so that they can get reliable results. These regulatory standards ensure that the medical device is just as good as any other medical device. Data transmission doesn’t demand a lot of regulation, as long as you can show the data was in the device and has been accurately transmitted to the data centre remotely. If you have remote devices that work the other way around - with decisions made remotely and sent to the device to alter its operation and the patient’s treatment - that increases the level of regulatory requirements. There is a big difference between medical devices for medical treatment and medical wellbeing and healthcare apps, which do not require rigorous testing.
Regulatory research for medical devices is normally carried out in the first phase of a development. What work is included in this?
SK: We start to think about regulatory requirements at the very first stage of the project. Key to the regulatory process is having a product requirement specification and a user requirement specification that defines what the user wants the product to do, what benefits the product will provide
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to the user, how they are going to use it and how you can make it easy for them. The other key thing is to understand what classification of medical device it is. Medical devices are classified according to the risk level; in Europe they are separated into Class 1, Class 2A, Class 2B, and Class 3.
Timing is important for business; people want their product to be launched in the quickest time possible. What do you think about the relationship between marketing timing and the long regulatory process when developing products?
SK: The amount of regulation, testing and documentation to check the immediate standards and compliance with regulations can vary depending on the complexity of the product. For simple products, the process can be very quick. If you are developing a complex machine or piece of equipment, then the process is more complicated. Following the correct regulatory route is essential. It may seem inconvenient to take an extra six months or year going through all the tests and approvals but planning this at the beginning can help.
IDC’s design engineers undertake the testing in addition to the design and development of the product. How does this help ensure the design complies with regulatory requirements?
SK: Understanding how to test and verify the product needs to be considered at an early stage of the project. The product design specification outlines everything you want that product to do. If for example, you are developing a drug infusion pump, you would say it needs to not weigh more than 300 grams, it should be able to deliver between 5ml and 20ml per hour, etc. Once you have all of the specifications, you think about how to prototype and manufacture the product and how to verify the design and test it. Time for testing can vary a lot between different types of products. Generally, simple products with fewer functions are much quicker to take through the process. The more features a product has, particularly with complicated electronics, the more testing required to meet standards. Typically projects need to plan for a few months of testing and certification with medical regulatory authorities.
COVER STORY
Leading the way What does a successful consumable diagnostics CMO look like? Bill Welch, Phillips-Medisize Corporation explains what the technical competencies and operating segments of a CMO for diagnostics consumables look like
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here is a clear trend in the diagnostics space towards higher complexity consumable products. Various components in a diagnostic assay are now integrated entirely on a single consumable, with a corresponding system analyser often only responsible for simple mechanical actions. This increase in complexity drives more compact and efficient diagnostics systems but it simultaneously raises new issues regarding manufacturing.
Automation design and implementation Complementary to assembly technology, a CMO must have competency in automation processes. This not only includes knowing when to automate a process based on the volumes and consumable itself, but also how to implement an automation solution that is cost and time optimised.
Sensor integration Biosensor technology through the use of components such as electrodes is increasing in the diagnostics space as a more compact alternative to traditional optical target detection methods. Electrode integration in point-of-care cartridges creates a single consumable that can handle sample collection, sample preparation, reagent addition and target detection.
The intricacy of emerging diagnostic consumables necessitates manufacturing competencies that span a wide range of disciplines, thereby raising the standards for a contract manufacturing organisation (CMO) to be successful in this space. As diagnostic companies continue to develop these complex consumables, the need for a strong relationship with a consumable diagnostics CMO specialising in everything from early product design to final product manufacturing will become increasingly more important.
Technical competencies and integration Many firms can provide moulding and basic manufacturing services. However, only a few within this space meet the standards of a true consumable diagnostics CMO, providing the technology integration necessary for manufacturing emerging consumable diagnostic products.
Replication (thermoplastic injection moulding) Competency in injection moulding is incredibly important when considering the high level of precision required by diagnostic products. For instance, the tolerance for manufacturing microfluidic products in the development stages is Âą1 micron; more extreme deviations would introduce the risk of bubble formation in the intersection of microfluidic channels and render the test and product unusable.
Reagent handling/storage Many consumables now have integrated components for all the necessary reagents to carry out a particular assay- effectively eliminating the need for external reagent addition. A CMO must be able to store and handle these reagents during the manufacturing process, including both liquid and powder reagents for blister pouches or separated compartments. 20
Supply chain Team spirit (TOP): Phillips-Medisize had the opportunity to manufacture a complex consumable diagnostic product in collaboration with a biopharmaceutical company Knowledge centre (ABOVE): Understanding technologies, emerging trends and market drivers is crucial, says Phillips-Medisize
Surface modification Basic surface modification can include hydrophilic or hydrophobic coatings. Quite often assays require more involved surface modifications, including antibody attachment. For instance, the surface modification necessary for a circulating tumour cell (CTC) assay requires a polycarbonate surface to go through UV light exposure and carboxylic acid treatment prior to the actual attachment of the antibodies.
Assembly technology Diagnostic consumables are composed of many component parts requiring sophisticated assembly technology. This includes the assembly of component parts such as the consumable’s plastic cartridge and spring system, as well as the binding of various materials through bonding or welding processes. WWW.MEDICALPLASTICSNEWS.COM
While a successful CMO does not need to manufacture all component parts in-house, it must be knowledgeable in the coordination and management of additional parts and activities to ensure a quality product for the customer.
Cleanroom/sterile manufacturing Maintaining a clean and sterile environment is a crucial aspect of all medical device manufacturing. The contamination of drug delivery devices could have severe consequences in terms of patient immunogenic response and contamination of diagnostic products compromises validity of the results. Of particular note are the ubiquitous RNase and DNase enzyme contaminants that are present in the environment and many biological materials. These enzymes degrade RNA and DNA, respectively, effectively threatening all molecular diagnostic assays that rely on the detection of fully intact RNA and DNA in samples. To counter this, there are many products available offering detection and elimination of the enzymes. It is important for a consumable diagnostics CMO therefore, to have cleanroom and sterile manufacturing knowledge and capacities to protect against any form of contamination such as RNase and DNase.
COVER STORY
manufacturing process chain- from design consultation to quality product manufacturing. This relationship and comprehensive service solution of course, would not be possible without the CMO’s thorough knowledge of the diagnostics market including its emerging trends and current technologies.
Consumable project case study In recent project, Phillips-Medisize had the opportunity to manufacture a complex consumable in collaboration with a biopharmaceutical company. This consumable included dry reagent pellets and microfluidic components; the integration of dry reagents called for assembly in a dry chamber space and the microfluidic components required extremely tight tolerances.
Operations: End-to-end integrated service solutions A diagnostic consumables CMO is first and foremost well-versed in the diagnostics market. A thorough understanding of the current technologies, emerging trends, and market drivers is a crucial characteristic of an ideal consumable diagnostics CMO. The rationale behind this notion is best illustrated by analysing the overall manufacturing chain: The cost-saving potential for manufacturing diagnostic consumables is almost entirely in the back-end-processing. Processes such as sealing, assembly, reagent storage and surface modifications all have a wide spectrum of potential costs. In other words, two cartridges performing the same assay could vary in cost of production due to processing discrepancies. The best practice for both diagnostics companies and CMOs therefore, is to collaborate at the design and development stage and evaluate how design for manufacture and assembly (DFMA) practices can best be applied moving down the chain. Early collaboration at the design stage not only provides costsavings at the processing stage but it also provides a CMO the opportunity to assess the potential for added-value to a design. In this way, a diagnostic consumables CMO is truly an integral part at every stage of the
Considering microfluidic device technology is intersecting multiple disciplines such as materials science, systems engineering, physics, chemistry and biology, the design and manufacturing of such products require a comprehensive array of abilities. These technologies funnelled into compact devices offer an exciting foundation for innovations. The manufacturing technologies for microfluidics are often broken into two different styles: Mould-based and mould-free. Mould-based techniques include casting, imprinting, hot embossing and injection moulding. Although these technologies are often less expensive at higher volume, they require significant cost to changes when a design needs to be altered. While a product is in development, it is natural for the development team to choose a manufacturing method that does not induce significant costs when a change is required. For this reason, most devices start with mould-free manufacturing. Mould-free techniques include lamination, photolithography, stereo lithography/3D printing and machining. These technologies, although more expensive on a per-part price basis at higher volumes offer an inexpensive cost to change designs. Mould-free manufacturing techniques are a much more advantageous and appealing route for early stage developers.
Again, because microfluidics is such a multidisciplinary technology it is important to develop all aspects/disciplines in parallel so that there are no bottlenecks in later development. From the technical competency and technology integration perspective, Phillips-Medisize is well positioned to develop this complex consumable. New air handler systems were installed for the dry chamber space requirement and our injection moulding competencies with tight tolerances are well established. In this case, however, the biopharmaceutical company had a relatively established prototype design for its consumable prior to PhillipsMedisize’s involvement. There was limited flexibility in terms of implementing design suggestions and certain geometric changes that could improve the overall quality and structure of the final manufactured product. Because there was relatively little involvement from PhillipsMedisize during the initial design and development stages there were ultimately more costly operations in the later manufacturing stages. In the end, few improvement suggestions from Phillips-Medisize could be implemented into the final product. Other products the company realised for customers were titration plates with 1536 bores for polymerase chain reaction in DNA replication (PCR). Consistent fluorescence of the base material had to be guaranteed here. Other important factors were the heatability of the plate at a high stability rate as well as an accuracy in the lower range of one hundredth of a millimetre. “These characteristics, as sought by the customer, have been developed specifically for this product. That is what gives PhillipsMedisize its unique market positioning,” said Bill Welch. The CMO has the appropriate in-house control facilities to check and test all products and also uses cytotoxicity tests, bioburden testing, LAL or risk analysis through FMEA. Validation of the processes follows DQ-, IQ-, OQ- und PQ procedures.
Summary
FIGURE 1 SHOWS MANUFACTURING PROCESS CHAIN WWW.MEDICALPLASTICSNEWS.COM
The increase in complex consumable products effectively translates to an increase in CMO opportunity. However, not all CMOs will be able to successfully participate in this space. To be a successful diagnostic consumables CMO there must be competency across all relevant technical disciplines and end-toend integrated service solutions - all built on a solid understanding of the market. As was illustrated by the case study, the model product development cycle cannot be fully achieved with technical competencies alone. Rather, these technical competencies must always be accompanied by end-to-end operations. A successful diagnostics consumable CMO can effectively apply both concepts for every manufacturing project. 21
MOVERS & SHAKERS
talking heads The medical plastics sector is very good at developing forward-thinking products. But what about the people behind this technology? Lu Rahman spoke to a handful of the industry’s key figures to see what makes them the drivers of innovation
‘I have the great pleasure of telling the Accumold story to the world’
it’s the experience that is key, not the machine.
Tell us why you love your job.
How have you made it a success?
I work to ensure our customer experience is the best it can be. I am blessed to work with other great people who also share that same vision. Together Accumold is a great success story.
What do you hope your customers say about the business?
That Accumold delivers what we promise and that the value of the relationship has strengthened their own position in the marketplace.
Best piece of advice you’ve ever received?
Micro-moulding expertise aside, Aaron Johnson, Accumold reveals why he loves nothing more than telling a story…
A
ccumold has been offering specialist micro-moulding since 1985. Aaron Johnson, vice president of marketing & customer strategy is known for his expertise on micromoulding in medical device design.
Tell us why you love your job.
I have the great pleasure of telling the Accumold story to the world. We offer a great service to our customers and I love spreading the news. The opportunity to meet new people, in new places is an exciting aspect of what I do.
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Best business moment of 2016?
The best business moment of 2016 was at Medtec Japan in April. This was Accumold’s first Japanese tradeshow. It was an excellent week meeting current vendors and customers as well as creating new opportunities.
What sets your company apart from its competitors?
Our experience. For more than 30 years Accumold has been dedicated to the art of micro-moulding. When it comes to pushing the limits with micro plastics,
A colleague/mentor once told me my sole responsibility in any job was to make my boss look good. I strive to be a good reflection of my boss’ trust in me to carry out my work with excellence.
Is there anything you would do differently?
I live two, maybe three minutes from Modern Plastics in Shelton, Connecticut. So, for starters I have no arduous commute. Modern Plastics is owned by a large parent company called Laird Plastics. While we are both plastic distribution companies, we are very different in our products, our customers and our approach to the market. I am fortunate that Laird allows us to run our business without interference. I also work with the most talented people in plastics distribution at Modern Plastics and I love our customers! As I’ve said before, “I manage my business, but my customers run our business.”
‘I’d come back as Paul McCartney’
If I could go back in time I would explore the world more as a young person. I would look to have spent time working abroad stretching my perspectives of different places and cultures.
What are you looking forward to doing in 2017? My oldest son graduates high school in 2017 and we are planning a big family holiday over the summer. It will be here before we know it!
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Bing Carbone loves his job but he’s a budding pop star at heart
MOVERS & SHAKERS
Best business moment of 2016?
Nothing gives me more pleasure than landing that big order! Maybe, several big orders in 2016, as we did. We are a ‘for profit’ business, and when you work hard (and long) to land a piece of business or a new contract that should be celebrated. We’ve celebrated a lot this year and I’m grateful for that.
What one thing sets your company apart from its competitors?
We have an irresistible value-proposition that globally customers find attractive enough to buy their plastics from us. We like people, we like solving their problems and we build long-lasting business relationships that helps our customers grow their businesses.
How have you made it a success?
Through my leadership skills. That’s it. I am paid to lead a great group of people, to set the goals, to have a plan, to have the vision and then to execute.
What do you hope your customers say about the business?
shop (gardening is my big hobby). Really though, I think I’ve lived my life well up to now and I’m only 54-years old and I have plenty of time left to accomplish so many business and personal goals I’ve set. I’m having a blast at Modern Plastics, have two great daughters, Jamie and Nicole and a terrific partner. It’s all good!
What are you looking forward to doing in 2017?
We want to grow sales and profits but what I really enjoy doing is adding value to the business, and for our customers. The demands and requirements, especially with medical plastics, are becoming more stringent. I want to be sure Modern Plastics is ready to manage the things our customers need from us. We’ll continue to make capital investments in the business to stay ahead of the curve (and our competition). I’m also looking forward to some new plastics materials and services we will introduce to the market in 2017.
Tell us why you love your job.
We did a survey recently and found out that 80% of our existing customers referred Modern Plastics to someone else. That speaks volumes about how our customers feel about us. We provide a ‘customer experience’ that is just how I would want to be treated if I were the customer.
The industry is evolving towards personalised medicine and wearables, in which plastics are playing a large role. It’s great to have your finger on the pulse of technology and be able to shape a piece of the future. We see medical technology products becoming more mobile allowing people to lead better lives.
Best piece of advice you’ve ever received?
Best business moment of 2016?
Many years ago an executive at my parent company Mark Steele said in one of his sales training meeting: “Remember, you are ALWAYS on display”. That never left me. Integrity is everything.
Is there anything you would do differently?
I’d practice harder on my bass guitar and come back as the next Paul McCartney! Maybe I’d own a garden
‘We have a deep understanding of industry requirements and manufacturing processes’
K 2016! Another highlight for us is the expansion of our main facility in Schwertberg, opening up possibilities for more individualised services to our customers.
What sets your company apart from its competitors?
The medical business is 100% focused on the industry. We have a deep understanding of its requirements and manufacturing processes.
In the medical plastics sector, Engel is a household name. Christoph Lhota tells us why he loves his work How have you made it a success?
The whole team is focused on the life-science market. This gives us a solid understanding of the sector. We are evolving into a partner rather than a supplier.
What do you hope your customers say about the business?
Our customers appreciate our understanding of the industry and its processes. Increasingly, we are becoming the partner of choice in turnkey projects, including GMP documentation. This shows how much confidence our customers have in us.
Best piece of advice you’ve ever received? Try to understand the customer and their requirements – develop the system concept on that basis. Don’t try to sell standard solutions.
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Is there anything you would do differently?
There are always points in individual projects that could have been handled differently. We perform analysis at the end of each project to determine what worked out well and what didn’t quite go according to plan. This lets us learn for future projects.
What are you looking forward to doing in 2017?
I’m looking forward to the implementation of Industry 4.0 projects. New manufacturing concepts will have a gamechanging effect. The next generation of factories will be characterised by revolutionary rather than evolutionary change. We will see whether a volume increase in medical manufacturing will continue to be achieved through larger machines and moulds or through completely different methods.
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INNOVATING TOGETHER H01
/ at Stand 8b
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Freudenberg Medical is a global partner for the design, development and manufacture of innovative medical device technologies. Our comprehensive technical capabilities range from the design and manufacture of minimally invasive, catheter, and handheld technology to the development and production of medical components utilizing complex materials and processes. We are leading the way in manufacturing high precision silicone and
thermoplastic components and tubing as well as metal hypotubes. Freudenberg Medical is part of the Freudenberg Group, a global 165-year old technology group that develops innovative products and services for more than 30 market segments worldwide. As an organization, we ensure that every project is supported by our unmatched range of global resources, financial stability, and the flexibility to optimize for business performance.
www.freudenbergmedical.com
mediprene@elasto.se • www.mediprene.com
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‘I often over-book’
MOVERS & SHAKERS
Tell us why you love your job.
It’s not often you have the opportunity to build a manufacturing facility in the community in which you live. The US has a history of providing innovative products to market quickly and competitively. Over the last 20-plus years we seen many companies moving offshore due to price challenges in the US market. It’s exciting to have the opportunity to change that and provide quality jobs here in US.
Best business moment of 2016?
Give someone the opportunity to say no, says Caitlyn Scaggs, Polymer Solutions Tell us why you love your job
I work for a company I believe in. Our science makes the world a better place. I’m surrounded by brilliant passionate, scientists – it’s contagious. I’m also given the freedom to come up with new ideas and implement them.
Best business moment of 2016?
We purchased a piece of analytical instrumentation, a high-temp GPC. Acquiring this is exciting itself and it also represents the health and growth of our company.
What sets your company apart from its competitors?
We recognise that results are more than just data. To meet our clients’ specific needs we must understand their context and provide expertise to support the data we generate in our labs.
How have you made it a success? By being curious and consistently looking for new ways to accomplish goals. I ask questions and surround myself with smart people.
What do you hope your customers say about the business? That they get answers from our data and expertise and their experience with our team is enjoyable.
Best piece of advice you’ve ever received?
Give someone the opportunity to say no. There is nothing to lose in asking for what you want, if you ask in a professional way. This is my father advice, which makes it all the more meaningful.
Walking into our new manufacturing facility on 4 January 2016. Project Blue Ridge was two years in the making. Starting up a new manufacturing facility is always a challenge, particularly in a highly regulated industry such as medical. We combined the Swiss business model with German engineering and US manufacturing expertise to create a top medical manufacturing facility.
‘Plan, do, check, act...’
What one thing sets your company apart from its competitors? Our people. We embrace entrepreneurial thinking and commitment. Our customers’ success is driven by our employees’ commitment to design and deliver high quality products, while maintaining the highest degree of regulatory compliance and a strong commitment to continuous improvement.
What do you hope your customers say about the business? That we are a longterm developmental partner providing top-notch customer service and high quality products.
Best piece of advice you’ve ever received?
Continuous improvement - plan, do, check, act. The worst thing is to become complacent with past success. Continuous improvement improves processes, provides innovation to customers and keeps people challenged. A workforce that embraces continuous improvement methodologies is unstoppable.
Jim Joy, Raumedic, says it’s a people thing…
Is there anything you would do differently?
I often over-book because I thrive on new and exciting opportunities. I am constantly battling to keep my schedule in check and not overextend myself.
What are you looking forward to doing in 2017?
We plan to introduce new project management software that will further streamline lab work processes and provide better data for making business decisions.
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What are you looking forward to doing in 2017?
Growth! As the business grows we’ll be able to provide high quality jobs and give back to the community that supported us.
Tell us why you love your job.
It’s a joy to bring a new material to the marketplace and make it a commercial success. Even though TOPAS COC has been available for years a lot of companies have yet to discover the benefits of our products in healthcare.
Best business moment of 2016?
Seeing multiple longterm medical customer development programs with our cyclic olefin copolymer (COC) moving to commercialisation almost simultaneously this autumn. Healthcare developments can take many years so seeing a number of them come to fruition at once is a rare treat.
What sets your company apart from its competitors? Our understanding and commitment to the healthcare marketplace.
How have you made it a success? We have developed a range of products that meet many healthcare needs and have cleared all major worldwide regulatory hurdles.
What do you hope your customers say about the business? That they’re pleased with our service, delighted that our materials have made their products better and their business more profitable.
Best piece of advice you’ve ever received? That there’s no such thing as not making a decision. Sitting still is a real problem in business and waiting
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‘We have developed products that meet many healthcare needs’
MOVERS & SHAKERS
How have you made it a success?
People. Our employees enthuse about what we do and this enthusiasm projects outwards.
We will be moving to larger premises again in early 2017 and have a number of exciting new systems and processes scheduled for release shortly after.
‘I’m looking forward to travelling to see our customers’
What do you hope your customers say about the business? That we go further, that we are a valued partner who makes an ongoing contribution. In essence, that we are good to work with.
Best piece of advice you’ve ever received?
Terry Whitmore, Henniker reveals what he’s learnt over the years, including the need to delegate! for perfect information is a recipe for being beaten to the punch.
Is there anything you would do differently?
I’d dig more deeply into the healthcare market at the beginning of my tenure to understand where our materials bring the most benefit.
What are you looking forward to doing in 2017?
We have many exciting developments under way with top medical firms and we expect to see several of these applications commercialised next year. We see trends toward wearable drug delivery accelerating, as well as more complex and precise diagnostic and microfluidic designs.
Best business moment of 2016? The delivery of our first system to China.
What sets your company apart from its competitors?
We recently registered the trademark ‘Passionate About Plasma’ – it’s this genuine passion for the basic science and technology that sets us apart. We really are passionate about plasma!
I was once asked a simple question, ‘would you be happy with that?’ I ask this same question of myself and of others many times a day.
Is there anything you would do differently?
I would delegate sooner. As a start-up it’s hard to give control of key areas of responsibility but it’s necessary for continuous growth.
What are you looking forward to doing in 2017?
‘We really are passionate about plasma!’
Tell us why you love your job.
It is gratifying to know the materials we manufacture are critical to the success of the global medical devices and pharmaceutical products. I have the opportunity to work with amazing people – employees and clients – solving problems every day.
Best business moment of 2016?
In 2016 we commissioned a dedicated cGPM facility for melt blending of active pharmaceutical ingredients and polymers. This was a substantial undertaking yet our team remained focused and committed throughout.
Tell us why you love your job.
It’s the diversity of the organisations that I deal with. Plasmas can solve numerous manufacturing issues relating to a range of materials. I can be speaking to a global manufacturer one day and a start-up the next – the materials and challenges are often similar.
It’s all about people and products says Lawrence Acquarulo, Foster Corporation,
What sets your company apart from its competitors?
Timothy Kneale, explains what excites him about TOPAS Advanced Polymers
The quality of staff and their commitment to the success of the company is unmatched. We encourage employees to submit their ideas. Some have had substantial impact on our business.
WWW.MEDICALPLASTICSNEWS.COM
How have you made it a success?
We find people who are good at what they do and we hire them. We also work hard to create a great environment.
What do you hope your customers say about the business? That they can count on us for quality work. Their confidence in our ability to provide consistently good products and services is our objective.
Best piece of advice you’ve ever received?
I was once advised to hire the best people I could find even if I couldn’t afford them. I practice this and found they pay for themselves many times over. People are our greatest asset.
What are you looking forward to doing in 2017?
I’m looking forward to spending more time travelling to see our global customers. I am also looking forward to personal travel with my own family. 27
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LAB-ON-A-CHIP
Frangible seal technology simplifies point-of-care diagnostics testing by enabling the controlled release of testing reagents via microfluidic formats Source: J-Pac Medical
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icrofluidics technology allows for extremely precise, small volumes of fluids to be dispensed via microscale devices. This has many implications for the medical market - particularly in regard to diagnostic applications. Microfluidic Rick Crane, diagnostic platforms utilising on-chip Innovation Services reagent blisters help eliminate multi-step Group, J-Pac Medical lab processes where human error and explains how frangible instrument contamination are most likely to occur, and expands the opportunities and burst seal for diagnostics testing and monitoring to technology enables be performed from the convenience of a optimised microfluidic patient’s home or doctor’s office rather diagnostic platforms than necessitating a laboratory. This type of point-of-care (POC) testing is driven by continuous technology improvements and the recognition that rapid test results offer economic benefits and potential patient benefits due to faster turn-around of testing results. More and more diagnostic device manufacturers see the value of easily incorporating burst and frangible seal reagent blister reservoirs into lateral flow and lab-ona-chip/card formats, providing significant cost savings as an alternative to the conventional eyedropper and bottled reagent systems with an added reassurance of test reliability. By integrating frangible seal technology into on-board reagent blisters of POC devices, the device manufacturer is able to better control performance variability, reduce overall manufacturing and disposal costs, and simplify the end-user experience. J-Pac Medical has made ongoing investments in unitof-use reagent reservoirs and unit dose delivery systems that integrate into various microfluidic-based diagnostic products for stat testing applications. J-Pac Medical has developed two reagent delivery technologies in single or multi-well formats for common lab-on-chip formats: burst (pierce-able) and frangible seal blisters.
Burst blisters are typically used in applications where the test equipment pierces and evacuates the fluid. Frangible seal blister technology is used to deliver controlled release of reagents using J-Pac’s differential seal technology. By using differential weld strengths designed to fail under specific pressure, unit-of-use reagent reservoirs in customised formats can be integrated into many existing diagnostic test platforms, helping manufacturers to create new offerings without drastic changes in the product line. This incorporation of on-board reagent blisters represents a new vision for improving the performance of microfluidics devices while at the same time reducing cost and offering a safe and reliable method for dispensing unit-of-measure volumes for diagnostic testing. With some upfront consideration of the system dynamics, custom blister designs can be optimised and applied to an entire testing platform, lowering costs across the entire product family. J-Pac Medical’s reagent blisters are designed to offer a convenient way to bring new or improved diagnostic products to market quickly and affordably and its reagent blister development kits allow device manufacturers to test the use of lab-on-chip reagent blisters with their own microfluidic formats for diagnostic applications. It is important that frangible seal manufacturers like J-Pac consider the specific requirements of every custom blister reservoir and design a blister solution that considers material compatibility, burst characteristics, reagent volume delivered, and long-term storage requirements. There are several different types of materials that can be used for reagent blisters and generally can be described as specialised foils and laminates used for cold- and thermo-formed packaging. These materials have various thicknesses and seal strengths that can be used for pierced or burst /push-through, peelable, and hybrid peelpush barriers.
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J-Pac’s custom delivery systems are designed to meet specific product requirements (including directionality of flow), protect the product, assure sterile transfer and maintain consistently successful delivery to patients. Furthermore, its highly automated production methods ensure precise reagent filling for single and multiple-well formats, allowing tests to be consistent and reproducible - whether customers need 10,000 or ten million reagent blisters. Depending on the form factor and release requirements, materials can be processed to create ‘frangible’ blister seal reservoirs with differential weld strengths designed and engineered to either be permanent or break, distort or yield on contact actuation or fail under a specific pressure. These weld strengths on the reservoir seals are a function of the material properties and applying unique welding processes that are combinations of pressure, temperature and time to meet the seal specification.
Incorporating frangible seal reagent blisters into the microfluidic testing device has resulted in documented cost reductions for device manufacturers. These include: IMPROVED PRODUCT SIMPLICITY: Multiplexing (using larger blister cards with multiple reagents) can reduce the overall component packaging, assembly steps and complexity of manipulating and dispensing fluids. GREATER STABILITY AND LONGER SHELF LIFE: Frangible seals support lower vapour barrier transmission rates, resulting in greater stability. They may extend shelf life by more than two years, in some cases eliminating the need and cost of desiccants. BETTER EASE OF INTEGRATION: Blisters are easily customized and integrated into many existing platforms; this helps manufacturers create new offerings without drastic - and costly - changes in the product line.
J-Pac’s understanding of these specialised material properties and processing capabilities allows it to dial-in the specific burst strength needed for activation - though not fragile enough to rupture prematurely due to routine handling, assembly or shipping activities.
EXACT DELIVERY VOLUME: Blisters can be filled without dead space air (100% fill) or with air to facilitate delivery and fluid clearance. By either method, an exact delivery volume can be specified into the design of the blister and fluid path.
Demonstrating this flexibility, a single blister design can be created with a frequently used foil material set and then sealed using different processing parameters. The sealed blisters have been actuated and measured for the force required to release the contents. The graph below demonstrates three different populations of burst blisters were created reproducibly for different burst values by making adjustments in the processing parameters
REDUCED WASTE: The reagent blister stores and delivers only the required amount of reagent needed for the determination, so excess reagent to over fill a secondary transfer bottle is not necessary. The liquid volume for single dose reagents can range from 30 μl to 5,000 μl. For example, a J-Pac Medical blister was designed to deliver 75 μl, results showed a mean of 76 μl, SD 0.33, CV 0.43%. REDUCED INVENTORY COSTS: Frangible seal technology reduces the number and cost of separate reagent bottles and applicators, as well as the associated costs of filling, packaging, and labeling. No secondary packaging, labels or inventory are required. Since the prices of application bottles alone can start at $0.20 each and a fully filled, sealed, weighed, labeled and boxed bottle can be nearly $1.00, this quickly adds up to significant savings if blisters are substituted. Similarly, there are cost savings for the end-user when they use devices with on-board frangible seal blisters. Frangible seals remove the guesswork and sampling error associated with manually dispensing liquid reagents. POC test processes can be simplified and made less complex, allowing expanded use by less trained personnel and ensuring accurate results even if technicians are distracted or interrupted.
This processing control of the seal strength allows the medical device manufacturer to have confidence that reservoirs will release their contents under defined and controlled conditions. Additional levels of seal strength (lbf -pounds force) can be developed and optimised using different material sets and processing conditions, thereby expanding the selectivity of the activation range of the blisters. Blister creation and performance metrics were provided by J-Pac Medical’s Innovation Services Group
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Frangible seals are UV resistant compared to plastics, resulting in a longer shelf life and less obsolescence of product. Additionally, they require less storage space and inventory management time by keeping reagents together within a reaction pack, so there is no chance of mixing with different lots or separating from the assigned or matched lot. Also, blister incorporation holds the promise of a smaller product ‘footprint’ and better portability. Blisters are also preferable from an environmental perspective, eliminating plastic storage bottles and eyedroppers to reduce the solid waste mass of slowly biodegradable polymers. The reservoirs are lightweight and disposable components when integrated into the device. There are no extra bottles or packages to throw away, resulting in reduced cost of disposing hazardous or biological waste. “Frangible Seal Reagent Blisters Deliver Precision Performance to Point-of-Care Diagnostic Testing,” J-Pac Medical LLC. 2015
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oday there exists a large and growing collection of medical, consumer, and industrial devices that harness the body’s electrical signals for applications. These applications range from the more obvious medical diagnostics, health and fitness trackers to entertainment, video games, and even workplace safety. Jeff Hendricks Biotectix All of these devices function in one of two outlines how polymeric ways: either by sensing electrical signals such as heart rate or electrocardiogram coatings can help improve (ECG) or by delivering electrical pulses to the performance of stimulate tissue, such as neural, cardiac medical and consumer or muscle tissue. For both sensing and electronic devices stimulation applications, the ability to quickly and safely transfer electrical signals across the tissue-electrode interface is critical for device function. Because the characteristics of the tissue-electrode interface vary significantly across applications, the interface must be optimised to achieve device performance, longevity, and safety. One key way to optimise the interfacial properties is to select an appropriate electrode material. Currently, different electrode materials are used to meet the requirements for a given device application. The physiological and mechanical environment, the duration of use, and the magnitude and characteristics of electrical communication all factor into electrode materials selection. For example, the rigorous environment and constant use over a period of years experienced by a cardiac pacing lead electrode is much more demanding than what a temporary ECG electrode worn on the skin for several hours must withstand. Furthermore, implantable electrodes must contend with the body’s chronic tissue response, which can often lead to fibrous encapsulation that can limit reliable long-term performance. Traditionally most of these applications, including both implanted electrodes and short-term-use electrodes, have relied on some type of precious metal for electrodes. Implanted stimulation electrodes are usually platinum or platinum-iridium; catheter electrodes are typically platinum or gold; and ECG/EEG/EMG electrodes
commonly use silver-silver chloride gels. While these materials are designed to satisfy the electrical and physiological requirements, they have limitations. They are generally expensive, have limited processing ability, and often have limited mechanical flexibility — which can be desirable for certain applications. 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. This produces noisier recordings with lower signal amplitude for sensing applications. For stimulation, the amount of charge that can be safely delivered before damage occurs to the electrode or tissue depends on the electrode size and the electrode material’s charge injection density. Since the values of charge injection density are fixed for a given material, as electrode size shrinks, employing electrode coatings made of materials with higher charge injection densities can help solve this problem. The charge injection densities for conducting polymers are reported to be nearly 100X higher than for bare platinum [Cogan S. Neural Stimulation and Recording Electrodes. Annu. Rev. Biomed. Eng. 2008 10:275-309]. 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 has developed a group of proprietary electrode materials based on conducting polymers that have been shown to facilitate electrical communication with the body. These are based on the polymer poly (3,4-ethylenedioxythiophene) or PEDOT, which has been used on large scales in the industrial and automotive industries for anti-static applications. Due to the chemistry of these polymeric electrode materials they are able
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to conduct charge via both electrons and ions, unlike traditional metals that conduct only via electrons. This makes them well-suited for transferring between electronic and ionic charge carriers at the tissue-electrode interface, leading to potentially superior recording and stimulation performance. These materials were originally developed by Professor David C Martin and his group at the University of Michigan for brain-computer interfaces as part of strategies to address the deteriorating long-term performance of microelectrodes implanted in the brain. With the support of investment and innovation firm Allied Minds, the technology was spun-off from the university into a new company, Biotectix. Since then the company has focused on the development, commercialisation, scale-up, and support of regulatory approval of these materials for medical devices. Biotectix’s Amplicoat is an electrode coating made from a proprietary blend of conducting polymers and biocompatible dopants that provide durability and increased conductivity. It is designed for use inside the body for cardiac and neural applications. Amplicoat is electrodeposited onto conductive components or subassemblies and can be applied at various stages during manufacturing. It is manufactured under an ISO 13485 certified quality system and is currently used clinically on CE-marked devices. Most customers ultimately incorporate the coating process into their own manufacturing process — whether in-house or at a contract manufacturer. Combined with the coating’s morphology, which packs a very large effective surface area into a small footprint, the conducting polymer-based coatings exhibit very low interfacial impedance. Along with low impedance, Amplicoat’s higher charge injection density (compared with traditionally used platinum or platinum-iridium) is able to increase safe charge delivery, which may significantly increase patient safety. These properties of Biotectix’s coatings make them ideally suited for enabling electrode miniaturisation towards the scale of individual cells for both sensing and stimulation applications. This is particularly important for creating low-profile, minimally-invasive devices and for creating high density electrode arrays for applications such as neural communication. For sensing devices, the coatings are designed to provide low noise, high amplitude signals, from very small electrodes. For stimulating devices, the coatings can be used to help provide extended battery life, extend safe stimulation capabilities and reduce electrode size. Furthermore, the coatings can be used either in conjunction with precious metals or with lower cost alloys for non-implant applications such as cardio mapping catheters. This could reduce the cost of manufacturing catheters and other medical devices and also opens new manufacturing methods. Tecticoat was developed to create comfortable, customised, high signal quality skin-contacting sensors for a variety of medical and consumer devices. This conductive polymer coating can be easily applied or patterned onto a variety of textiles, foams and other insulating materials to create soft and flexible electrodes. These electrodes fall under the category of dry electrodes and can be used to collect ECG, EEG, or EMG signals for
Cover story: Biotectix’s Amplicoat conducting polymer coatings on cardiac electrophysiology catheters (right), on stainless steel tubing and on MP35 rod (middle), and Tecticoat conducting polymer coatings on foam for medical applications
medical or health monitoring use, as well as for electrical stimulation applications such as Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief, rehabilitation, or for neural training applications. One of the more widely used applications for Tecticoat is for creating non-invasive cardiac monitoring electrodes. Traditional ECG electrodes primarily use silver-silver chloride gel electrodes for their low contact resistance. A major drawback of these non-polarisable ECG electrodes is that the signal quality deteriorates as the gel inside them dries out. As a result, they cannot be used for long-term use and are considered as disposable electrodes. Other downsides of these electrodes are that they can leave residue on the skin and can cause irritation after prolonged use for several hours. Biotectix’s Tecticoattreated ECG electrodes are aimed at circumventing these drawbacks and can be made from foam or various textiles. Due to the composition of the electrodes, they are able to provide the same signal quality and amplitude as off-the-shelf ECG electrodes, but without the use of wet gel, reducing gel residue, skin irritation and making them more suitable for long-term monitoring. 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.
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Stop bugging me! H
ospital Acquired Infections (HAIs) affect millions of people around the world and cost healthcare systems billions. Currently one in 20 in-patients (300,000 people in the UK), suffer from a HAI, Dave Hampton, increasing the length of their hospital stay Camstent, outlines by up to 350%. More people die from HAIs a solution for than breast cancer, car crashes or diabetes. Government research found that even a 10% reducing infections reduction in infections could save the NHS using bacteria- 93.1m per annum.
phobic coatings
Catheter Acquired Urinary Tract Infections (CAUTIs) are the single largest cause of hospital acquired infections today, according to both the CDC in the US and the NHS in the UK. CAUTIs develop in many patients within days of catheter insertion and, if the duration of catheterisation is prolonged, then the chances of developing an infection increase by 3% per day. This is because it is common for bacteria biofilms to form on the catheter surface, leading to damage, inflammation and infection via the adjacent tissues. Biofilms are thin layers of microorganisms, usually protozoa and bacteria, which colonise exposed surfaces of medical devices. Antibacterial coatings, whether silver or antibiotic impregnated, are intended to kill the biofilms once they have formed, minimising damage to exposed tissue. In practice, however, this approach is ineffective at preventing the growth of bacterial biofilms - existing coated catheters on the market have not reduced CAUTIs.
Using polymers to reduce infections Research published in Nature Biotechnology in 2012 pointed to a different, more promising approach. Rather than aiming to kill bacteria, researchers looked to better protect against HAIs by changing the physical properties of surfaces to make them inhospitable to bacteria. Camstent is pursuing this bacteria-phobic approach for reducing HAIs. Based on research from the Universities of Cambridge, Nottingham and Sheffield, Camstent’s polymer coating essentially creates a non-stick surface on the medical device that has been treated, inhibiting biofilm formation by pathogenic microorganisms in a laboratory environment. The aim is to prevent adhesion and colonisation of the surfaces of consumable medical devices rather than focusing on killing the organisms, and thus reduce infection rates by eliminating biofilm formation.
in HAIs. Variations in the component molecules may yield further formulations that should be able to resist blood products or protein attachment across a wide range of substrate materials used in medical devices.
The benefits The bacteria-phobic coating approach could offer clinical advantages compared with other methods of reducing HAIs: Laboratory tests show a greater resistance to biofilm development, compared with alternatives, inhibiting the formation of bacterial colonies It is biologically inert, and so should avoid inflammation or other toxic side effects The coating is designed to be robust and to remain attached to the catheter under normal use conditions Its smooth, thin surface coating aims to minimise discomfort for the patient As it is simply a surface modification, it is nonpharmacologic, without the need for delivery systems, dosing, side effects, and drug testing Since it does not kill the bacteria, it does not stimulate the emergence of resistant organisms It is cost-effective to create treated devices, as the Camstent coating is applied as a supplemental step at the end of the manufacturing process and before sterilisation
Where are we now? Given that CAUTIs are the largest group of HAIs, the company’s development efforts are directed towards addressing this pressing need. Camstent has recently opened its own pilot manufacturing facility to produce treated catheters, and will work with researchers and clinicians to further research the validity of this approach. The human and financial cost of HAIs continue to rise, but existing products have failed to meet the need, meaning that new approaches are required to overcome the challenge. Lab tests show that bacteria-phobic polymer coatings offer significant advantages over other methods when it comes to reducing HAIs, and there is further potential to apply the methods across a wide variety of medical devices.
Neither a drug nor a biological solution, the product can be applied to silicone/ silastic surfaces, notably Foley catheters. Laboratory studies have shown that Camstent coated products perform longer and are more effective than market -eading alternatives with colonisation reduced ten-fold in independent comparative tests.
How Camstent works Camstent’s approach uses proprietary polymers, guided by Nottingham’s research and formulated from two methacrylate components. One is optimised to prevent bacteria from maintaining contact with the device surface, while the other imparts the flexibility required for clinical safety. Laminated onto surfaces as thin films, this coating aims to inhibit surface colonisation of catheters by organisms commonly found in the urinary tract, implicated 36
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Meet the all-stars… I
t’s been a fruitful year on MPN - as we approach the end of the year we’re currently planning the launch of a North American issue. The magazine has always had a strong connection with our audience in this region which has grown steadily year on year. With With the launch of that in mind, the time’s right to offer MPN North American these readers a dedicated publication of only a few months their own. The MPN team is very excited about this launch and we’re looking away, Lu Rahman forward to hearing more news from our selects some of the audience in North America and the work expertise coming out of being carried out in the medical plastics sector.
this region throughout the last year
We’ve had some great stories and innovation from North American based companies over the last year. As always Accumold is at the forefront of the micro-moulding sector. In the summer the company looked at the future of medical device design and the role that micro-moulding has to play. The company’s Aaron Johnson recognised the “growing convergence between medical device and consumer electronics”. He outlined the way that in addition to this bringing innovation to the end user “it has also brought an interesting kind of pressure to the design and manufacturing world. The general population of the modern world has come to expect that all of their devices, medical or not, be ‘smart’ in some way”. The growth of digital health has been well documented on MPN. Johnson highlighted: “The growing expectation that devices built for a special purpose now function in multiple and sometimes completely foreign ways. It wasn’t a stretch to accept that a hearing aid could double as Bluetooth connection between a mobile phone or television, but what if it also took your temperature, measured your heart-rate or counted your steps? It’s already connected to your body so why not? Think of all of the items worn by individuals that could have multiple functions. Any one of them could function as a medical device (or quasi-medical device) many of which already do. So what’s next?”
not just a single reason, but a combination of features and benefits. These plastics should be selected during the design process due to their ability to meet the application requirements, quality of the device, productivity and/or save costs.” From selecting the right performance plastics, sterilisation methods to advice on medical plastics distributors, Carbone offered words of wisdom. In the May / June issue of the magazine Peter Galland, Teknor Apex Company looked at plasticisers and the key factors that need to be considered when choosing between trioctyl trimellitate (TOTM) and dioctyl terephthalate (DOTP). This included cost, purity, toxicology, performance and REACH status. Known for its manufacture of medicalgrade PVC compounds, the company also produces plasticisers and Galland outlined how to determine the best alternative to DEHP for PVC medical devices. Earlier in the year Galland, along with Ross Van Royen looked at the challenges in compounding medical polymers. As well as a dedicated processing lines, the authors described the need for sophisticated process controls and production monitoring systems to meet “stringent codes and critical performance requirements as well as to provide device manufacturers with lot to lot documentation.”
MEETING POINT: Aaron Johnson, Accumold recognised the“growing convergence between medical device and consumer electronics”
And within this sits micro-moulding which Johnson rightly points out is one of the key technological innovations that enables the design and manufacture of the next generation of medical devices. As always material selection is a key consideration in the design of medical plastic devices. Bing Carbone, Modern Plastics is a wealth of expertise when it comes to choosing the right material. According to Carbone: “Device manufacturers have a number of criteria to consider when selecting plastic materials. High-performance plastics are the natural choice
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SECTOR HIGHLIGHTS
Galland and Van Royen examined PVC compounds and TPEs. They noted that “a major challenge confronting PVC device manufacturers today” is issues involving ortho-phthalate plasticisers, particularly DEHP, which is widely used in medical-grade PVC and has decades of application history and that “selecting alternative plasticisers for use in producing medical compounds is not a simple matter, since most alternatives now available entail some compromise in cost or performance in comparison with DEHP, and different device applications pose different plasticising requirements”. They also brought to attention that fact that, “TPEs bring unique capabilities to the medical device industry, and in some cases these benefits represent valuable cost/performance advantages over conventional incumbent materials such as PVC and thermoset rubber”.
LOOKING AHEAD: J-Pac Medical’s Jeff Barrett outlined the company’s plans for MPN at the start of the year
life and better patient outcomes. However, this can only happen if it’s supported by analytical science and proper lab techniques. Later in the year the company’s Caitlyn Scaggs outlined the key aspects when choosing an independent testing lab. She pointed out: “You wouldn’t trust your health and well being to a physician that didn’t pass their medical boards—why would you trust high-consequence laboratory testing to a company that lacks proper accreditation? If you’re developing a product that will have end use within the medical industry you need assurance that the results supporting your product are reliable.”
Two of the challenges facing compounders of medical-grade TPEs are developing a range of compounds broad enough to match the diversity of requirements in the many well-established applications dominated by conventional materials and perfecting the TPE compounds not just in terms of properties to be found on data sheets but in terms of real-world requirements. EXPERT OPINION: “The Semenette was invented by combining my knowledge and expertise in women’s reproductive health, along with my hope of conceiving a child”, said Stephanie Berman, Berman Innovations
WATER WORLD: Jason Smith, Polymer Solutions outlined the way that hydrogels are poised to improve quality of life and better patient outcomes
One of the most popular stories of the year came from Berman Innovations. Owner Stephanie Berman’s POP by The Semenette unites a sex toy with a device that aids conception.
Berman said: “The Semenette was invented by combining my knowledge and expertise in women’s reproductive health, along with my hope of conceiving a child with my wife, which we were able to do with our prototype. Three years later we have successfully launched the second iteration of the toy, which we were able to use to conceive our second child! In those three years, we have found there are many other markets for which POP is ideal; the new version of the toy reflects those applications.” J-Pac Medical’s Jeff Barrett outlined the company’s plans for MPN at the start of the year. Known for its capabilities in sterile packaging, Barrett revealed that the business would be investing heavily in medical device capabilities and expanding its existing manufacturing services for devices in orthopaedic, sports medicine and cardiovascular fields. Always keen to share its expertise with MPN, Polymer Solutions’ Jason Smith looked at hydrogels in the March April issue . With common uses for this molecular sponge-like material including wound care management, drug delivery, cartilage replacement and as a material for contact lenses, the use of these substances is on the rise as the industry understands them more. Smith outlined the way that hydrogels are poised to improve quality of
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TAKING SHAPE Lu Rahman looks at some of the latest developments in the 3D printing sector and how origami has become a surprising new inspiration
The medical plastics sector hears about the cutting edge of the 3D industry on a regular basis but it’s great when the wider public gets to hear of the progress being made in the field The Guardian highlighted the way in which 3D printing has the potential to “revolutionise the medical profession” and how scanning techniques are helping the customisable artificial limbs. Amy Fallon describes how a trial by NIA Technolgies provides mobility devices for children and young people “more quickly than the conventionally produced plaster cast method – using a 3D printer and other 3D technology”. Matt Ratto, Nia’s chief science officer told the newspaper: “Our project leap frogs current developed world fabrication techniques by using 3D printing to produce devices that are actually being used by patients”. The trial involves the production of two different types of mobility device using scanning, modelling and printing technologies.
Self-folding medical implants Innovation continues in the medical sector for 3D printing. Researchers at TU Delft have made flat surfaces that are 3D printed and then ‘taught’ how to self-fold later. The materials are potentially very well suited for all kinds of medical implants.
Complete regeneration of functional tissues has become the holy grail of tissue engineering and could revolutionise treatment of many diseases. Effective tissue regeneration often calls for multifunctional biomaterials. A lot of research is currently going in this field. One example being the large research project, led by Maastricht UMC and with TU Delft as one of the participants, in the field of ‘smart’ 3D printed implants for recovery of bone defects. The project if it’s successful, will lead to faster recovery of patients and less operations. But the potential applications of 3D printed bio-implants are much bigger than only bone defects. Dr Amir Zadpoor is one of the researchers at TU Delft. “Ideally, biomaterials should be optimised not only in terms of their 3D structure but also in terms of their surface nano-patterns,” he said. “3D printing enables us to create very complex 3D structures, but the access to the surface is very limited during the 3D printing process. Nanolithography techniques enable generation of very complex surface nanopatterns but generally only on flat surfaces. There was no way of combining arbitrarily complex 3D structures with arbitrarily complex surface nano-patterns.”
Zadpoor looks to the Japanese art of origami to solve this deadlock. Flat surfaces are 3D printed in a way to teach them how to self-fold. The surface is then decorated with complex nano-patterns. Finally, the self-folding mechanism is activated (for instance by a change in temperature) to enable folding of the flat sheet and the formation of complex 3D structures. Zadpoor: “Nature uses various activation mechanisms to programme complex transformations in the shape and functionality of living organisms. Inspired by such natural events, our team developed initially flat (two-dimensional) programmable materials that when triggered by a stimulus such as temperature, could self-transform their shape into a complex three-dimensional geometry.” Shape memory polymer (SMP) and hyperelastic polymers programme four basic modes of shape-shifting. Some of the modes of shape-shifting were then integrated into other twodimensional constructs to obtain self-twisting DNA-inspired structures, programmed pattern development in cellular solids, self-folding origami, and selforganising fibres.
Surgical aids Earlier this year Stratasys outlined what it called a ‘major advance in surgical pre-planning’ led by 3D printed anatomical models. The company teamed up with the Jacobs Institute physicians at Kaleida Health’s Gates Vascular Institute and biomedical engineers at the University at Buffalo for the design of a new approach to repair a complex brain aneurysm. The result? A life-like 3D printed replica that reduces risks associated with this complex surgery and corrected a near-fatal condition. Dr Adnan Siddiqui, chief medical officer at The Jacobs Institute described how they took an image of the aneurysm based on scans to generate an exact replica of the entire brain vessel anatomy and how the Stratasys 3D printed model enabled the creation of a better way to treat the patient. Stratasys technology has also been used by the Kobe University Hospital in Japan which is using model replicas of patient’s organs as educational tools and at the University of Minnesota Medical School, where a US Army-funded study is developing anatomically accurate airway trainers to improve training for medical emergencies.
“This work is just one little step towards better medical implants’, said Zadpoor, “but we are definitely making exciting progress.”
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3D PRINTING
Ian Matthew, Owen Mumford 3D Printing, explains how to harness the benefits and identify the restrictions of this technology
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ccording to a new mar ket research report, published by Credence Research, the global 3D printing in healthcare market1 is estimated to expand at a CAGR of 17.5% from 2016 to 2023. But does the 3D printer present those designing and manufacturing medical devices with any restrictions? The rise in healthcare IT solutions is the most significant factor spreading the adoption of 3D printing technology in the medical sector. At Owen Mumford, we’ve harnessed 3D printing as a valuable tool for early design developments. It contributes to proving a design principle and assessing part assembly and geometry for new devices. 3D printing allows us to improve our understanding of a concept and inform early development decisions, as well as highlight fundamental problems that can be quickly rectified. However, it’s important to understand the output required when producing a prototype, as this will affect the 3D method chosen or justify a decision to use a different prototyping method entirely. This means firstly understanding what the restrictions are, and then developing methods to overcome them. There are multiple 3D printing techniques that can be deployed for different requirements, including: FUSED DEPOSITION MODELLING (FDM) - an additive manufacturing technology commonly used for modelling, prototyping and production applications. STEREOLITHOGRAPHY (SLA) PRINTING a technique or process to create aesthetic prototypes to present to customers and exhibit at trade shows. POLYJET - used for iterative designs, this is the predominant medium of 3D prototyping. Due to the brittle nature of polyjet, this technique can’t be used for any loading or creep testing.
Alongside these forms of 3D printing there’s another set of techniques, which are required to create more production representative parts: INJECTION MOULDING – we’ve developed a dedicated bolster set which uses 3D printed inserts, positioned correctly into an injection moulding machine. This technique enables a developmental injection moulding process to be used, across different plastics and grades of material, making the entire prototyping process more efficient and accurate. SOFT TOOLING – we use an external company to provide soft tooling options for injection moulding parts at much higher volumes. These are particularly beneficial for early usability studies and functional testing in which we need a representative manufacturing process, along with higher volumes compared to rapid prototyping. While our 3D printing machines are extremely relevant, there are still some restrictions to consider, including: Structural integrity of printed parts - the layered printing process causes structural weakness, resulting in failures that don’t occur in moulded parts. Mechanism functionality - the material chosen impacts the surface finish and the resulting friction, directly impacting on the mechanical functionality of the design. The limited range of materials available from 3D printing doesn’t allow detailed incremental design changes, which can be the difference between a working and non-working design. Wear of material over time restricts intensity of testing – a substantial amount of testing is required to ensure the product is capable of achieving its life requirements. It’s often the case that printed parts will cause a failure, which would not be seen with a moulded part. Dimensional accuracy – the process of making a part, its geometry and its material WWW.MEDICALPLASTICSNEWS.COM
are the main factors affecting dimensional accuracy. These factors all contribute to the capability of the manufacturing process, which is critical to understand when defining dimensional tolerances. Components must be designed to function throughout the entire tolerance range; the range achieved by a 3D printed part will not reflect the moulded tolerance. Response under impact loading – impact testing is limited with 3D parts. These parts can demonstrate an area of weakness due to geometry. Any further resolution of performance under loading requires representative material and manufacturing processes. We’re striving to use more materials in our production environment, including engineering grade polymers to further develop devices and comply with updated regulations. 3D printing allows the use of generic materials groups (such as ABS) but to optimise designs we require specific grades of material groups. Material properties of different grades can have a significant effect on the performance of a part or assembly. This level of resolution and adjustment is not possible with rapid prototype techniques. As we continue to see more technological advancements in the way in which we design and manufacture medical devices, we’re able to assess more concepts at a much lower cost meaning we can continue to be truly innovative at a much lower risk. Companies must continue to keep abreast of design to manufacturing and allow themselves to harness the benefits of 3D printing.
References 1. Credence Research (2016) “Global 3D Printing in Healthcare Market- Growth, Share, Opportunities and Competitive Analysis, 2016 – 2023” Report Code: 57906-06-16 Available at http://credenceresearch.com/report/3dprinting-in-healthcare-market
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POLYMER TECHNOLOGY
Close to the bone Martin Ganz, Micro Systems UK, explains why PEEK offers success for the manufacture of medical parts and the rise behind its popularity
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oday more and more manufacturers of medical products are using PEEK (polyetheretherketone) for bone surgery, but also in areas of traumatology and orthopaedics. Why PEEK? Because this material is biocompatible, inert to body fluids and can be processed relatively easy with high precision micro moulding for individual implants or surgical instruments. For medical products, PEEK provides a great benefit: It saves weight, allows more design freedom and a greater functional integration, it also scores with X-ray transparency and elasticity which corresponds approximately to bone. At the same time it is a lower cost alternative to Titan the classic implant material, especially when using medical instruments or endoscopes, where the good electrical insulation properties of PEEK come into play. PEEK parts are often produced by standard injection moulding, but this process reaches quickly physical boundaries for high precisions medical parts. This technology can often not achieve the recommended part precision, especially not the necessary long-term quality stability and besides always has a great material loss by needing oversized sprue. To improve this situation Micro Systems UK. The Austria operation is using micro moulding machines to process PEEK materials. The focus of our production starts with a design study through to mass production of high precision micro plastic part. The key to successes is using only the latest and suitable production equipment, optimising all influencing parameter
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by DOE and stabilising environment production conditions. Micro Systems UK operates a quality assurance management system with accreditation to ISO 9001 and ISO 13485. Medical devices that are intended for long-term contact with body tissues must meet particularly high quality requirements for registration in Europe or in the US. The manufacturers have to demonstrate on the one hand, that the raw materials are suitable for the respective area of application, and on the other hand demonstrate how they ensure consistent quality. For example, in further processing using injection moulding, different cooling speeds influence the material properties of PEEK. Also, the duration and temperature of the heat treatment has a direct influence on the crystallinity of the PEEK polymers and thus their mechanical properties. That is on the one hand, that the material properties can be specifically controlled, on the other hand any variation in the production process change the quality of the parts. So it is evidently important to stabilise every relevant process condition to get high quality parts over a long production time. Besides the injection moulding machine which controls process temperature of 400 C and injection pressure up to 3500Bar, is one key feature of a stable injection moulding process. Due to the fact that PEEK needs a cavity surface temperature of up to 220 C, it is evident to take into account, in the design phase, a uniform tempering of the tool. The heat distribution in the tool has to be calculated and optimised before manufacturing like mould
POLYMER TECHNOLOGY
SMALL WONDER: Instrument housings moulded in PEEK with 0.3mm wall thickness used for minimally invasive surgery
flow analyses, which are used to calculated the filling characteristic of the moulded parts. For micro moulds we use electric elements to heat the tool instead of oil tempering device; the reason for this is the efficiency of energy, particular when running this device in the clean room, additional electric heating creating less dust and are safer for the machine operator. Also due to the fact that medical grade PEEK price can rise up to over ÂŁ2000 per kilo it is evident that the sprue weight is as small as possible in relation to the micro part. On standard injection moulding machines there is a physical limitation reducing the shot weight due to the reason of the cold material slug on the machine nozzle or the hot runner tip. Optimised micro moulding machines allowed us
much smaller sprues in the design than using standard moulding machines. The micro moulding processes guarantee injection of thermal homogenies material without a cold material slug so 0.1 gram shot weight or below is possible. With this feature the weight ratio sprue to part is much smaller and saves material and costs. Of course only in combination with optimised screw geometry to ensure that the resistance time of the plastic in the barrel is still below the specification of the material supplier. In general micro moulding is physically equal to conventional moulding, only faster with a higher dynamic and more accurate. Micro parts out of PEEK with wall thickness below 150 Âľm are achievable depending on flow length and PEEK type. Regarding the size of injection point we recommend always
using as big as possible to achieve a stable process, but often on micro parts there is not enough space on the part to design an optimal gate. Gate point dimension below 0.2 mm are critical in PEEK and must be examined in practical test. The complete detachment of ligaments, tendons or other soft tissues from their associated bones within the body is relatively commonplace injuries, particularly among athletes. Such injuries are generally the result of excessive stresses being placed on these tissues. For example, tissue detachment may occur as the result of an accident such as a fall, over-exertion during a work-related activity, during the course of an athletic event, or activities. For a complete detachment, however, surgery may be needed to re-attach the soft tissue to its associated bone or bones. Numerous devices made out of PEEK material are currently available to re-attach soft tissue to bone. Examples of such currently-available devices include screws, staples, suture anchors and tacks.
For many years Micro Systems UK has processed PEEK for different applications from thin wall up to 5mm wall thickness, from part weight of 0.001gramme to over 1g. Using the latest micro moulding technology gives a significant improvement of part quality and this is confirmed with simultaneous cost reduction due to faster cycle time and smaller sprue. The improved long-term stability of the production process allowed additionally reduced operator time. It is relatively straightforward to process PEEK as long as you know exactly your process window and equipment. Strict operating procedures are recommended for heating up and shutting down the machine cell enabling it to reach a proper and stable productions process. Monitoring and checks are carried out regularly throughout the entire process, ensuring that the micro-injection mould parts are all of the same high quality before shipping to the customer. I personally look forward to the next PEEK project!
TAKE A PEEK: A PEEK anchor to re-attach soft tissue to bone
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MEDTECH at the movies
HYSTERICAL HISTORY GETS THE HOLLYWOOD TREATMENT
MPN looks at Hysteria, a movie about the birth of one of the first electrical medical devices, which later found a very different application
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nce a common medical diagnosis, female hysteria was, in the nineteenth century, the inaccurate terminology used to account for a wide variety of symptoms. One physician at the time went so far as to suggest that a quarter of all women suffer from hysteria. The movie Hysteria deals with the misconceptions of the time, as well as the emergence of what proved a very popular treatment genital massaging. Dr Mortimer Granville (portrayed by Hugh Dancy) takes a job working for Dr Dalrymple (Jonathan Pryce), a noted physician and a specialist in treating hysteria. Dr Dalrymple’s most popular approach involves administering a massage, with a curtain to protect the patient’s modesty, to the genital area. The doctors describe “paroxysmal convulsions” – by which they really mean orgasms, although it’s possible that they didn’t make this connection at the time. Granville fits into the business well, and gains a reputation for his massage skills. Dalrymple has high hopes that he will marry his daughter Emily, and perhaps even take over the business. Dalrymple also has another daughter, Charlotte (Maggie Gyllenhall), who works in a settlement house. Settlement houses were part of a Victorian social movement to try and elevate the lower classes by bringing them together with volunteers f r o m middle c l a s s
society who would provide healthcare, education and skills. Dalrymple doesn’t approve of his daughter’s vocation, and asks Granville to help dissuade her from this line of work. Granville’s reputation is growing, and demand for the therapy is on the up. So much so in fact that he suffers a hand cramp, which results in his dismissal. Luckily for him, he has a friend has recently invented an electrical feather duster. Granville adapts the idea for the purpose of massage, (the resultant medical device actually became known as the Granville Hammer).
pledges to use the funds to open a clinic at Charlotte’s settlement house. The two fall in love and marry.
Dalrymple welcomes him back into the fold, and he and Emily are engaged.
Writing in The Guardian, Riddell says: “Did the real Dr Granville invent an electronic device for massage? Yes. Was it anything to do with the female orgasm? No. He actually invented it to help stimulate male pain relief, just as massage is used today.”
During the engagement party, Emily’s sister Charlotte is arrested protecting a a friend from a police officer. In Charlotte’s trial, the prosecutor suggests that Charlotte ought to be sent to a sanatorium and given a hysterectomy. Granville is called up to testify, and says that the criteria for hysteria are far too broad, calling into question the use of hysteria as a diagnosis. He speaks to Charlotte’s kind and giving character. As a result of his heartfelt plea, the j u d g e g i v e s Charlotte a much lighter sentence of thirty days in prison. Emily has a change of heart on the engagement, and calls things off with Granville. With his device now a commercial success, Granville, now a wealthy man,
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You may already be aware of this story, or at least the essence of it. That Victorian doctors accidentally invented the electrical vibrator as a medical device, with no intention or knowledge that it would evolve into a sex toy is a titbit that often appears in those ‘did you know’ kind of conversations. But is there any truth to the tale? Yes and no, according to cultural historian Fern Riddell.
She continues: “The vibrators from the Victorian period are the least orgasmic devices you have ever seen, because they had nothing to do with sex. They were used for massage, not masturbation. And the idea that a woman would be brought to orgasm by a device that rotates with a loud grinding buzz, and pummels you with the same finesse as a steam-engine, just doesn’t work. Especially when you compare it with the Victorian sex aides that were created for pleasure. From sex toys to sex chairs, condoms and contraceptives, the Victorians had many of the things we see today. They used rubber, wood, ivory, and leather; some are delicately crafted from silver, others decorated in enamel flowers and hidden inside everyday objects, like a walking cane.” So, there you have it. Hysterical history gets the Hollywood treatment.
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