N AMERIC AN EDITION
MEDICAL PLASTICS news
On r e p e a t +
D a v i s -S t a n d a r d ’ s p e r p e t u a l i n n o v a t i o n
STICK WITH IT: WHY ADHESIVES ARE BIG BUSINESS FOCUS ON BIOABSORBABLE POLYMERS
ISSUE 4
Oct/Nov/Dec 2017
WWW.MEDICALPLASTICSNEWS.COM
ADVANCING MEDICAL PLASTICS
Carclo Technical Plastics, 600 Depot St, Latrobe Pa. 15650. Tel: (724)-539-1833 Email: sales@carclo-plc.com www.carclo-ctp.com
CONTENTS MPN North America | Issue 4
Regulars
Features
3 Comment Lu Rahman looks at how the space between the medical device, digital health and pharma sectors is decreasing
15 Deal or no deal Lu Rahman looks at some of the recent M&A activity taking place in the industry 16 Winning moment Lu Rahman picks some of the stand-out moments and businesses of 2017
5 News focus 8 Digital spy 12 Cover story Davis-Standard explains how it stays at the top of its field through perpetual innovation 32 Back to the future
19 Walking the walk How soft robotics help poststroke patients walk 20 Disappearing world Evonik Health Care explains how medical device companies can use bioresorbable materials to develop devices which improve patient outcomes 23 Automatically yours Sepro Group answers questions about robots and automation for cleanroom molding.
24 Skin deep Vancive Medical Technologies and Pronat Medical, explain why material selection matters when it comes to skin-worn wearables 27 Take heart At UC Davis, work is underway on a new cardiac catheter that combines light and ultrasound to measure plaques 28 Weighing in The pros and cons of processing methods for medical polymers from Trelleborg Sealing Solutions 30 In the round Raumedic, discusses coextrusion technology and its potential for opening up areas of medical applications
WWW.MEDICALPLASTICSNEWS.COM
1
Xianbo Hu Ph.D., Principle Scientist “I am inspired to solve technical challenges, providing innovative solutions sets Vancive apart.”
Inspiration. Innovation. Dedication. Advanced Medical Adhesive Applications that Touch Lives With a relentless dedication to what’s next, the people within Vancive’s Core Business Segments see future possibilities. Offering scalable and inspired solutions for OEMs and Converters, Vancive Medical Technologies® responds to the unique needs and changing requirements of our customers. Dedicated professionals such as Xianbo Hu are agile, forward thinking, open to new ideas, and have a vision that helps customers and partners succeed. Download the Vancive™ Product Finder App Available on the App Store® and Google Play™
© 2016 Avery Dennison Corporation. All rights reserved. Avery Dennison, Vancive Medical Technologies, Vancive, and Design “V” Logo are trademarks of Avery Dennison Corporation. Android, Google Play, and the Google Play logo are trademarks of Google Inc. Apple and the Apple logo are trademarks of Apple Inc., registered in the U.S. and other countries. App Store is a service mark of Apple Inc. MTR-MKT-000284-A
CREDITS
EDITOR’S
comment
group editor | lu rahman deputy group editor | dave gray reporter | reece armstrong advertising | gaurav avasthi art | sam hamlyn graphic design | matt clarke publisher | duncan wood Medical Plastics News is available on free subscription to readers qualifying under the publisher’s terms of control. Those outside the criteria may subscribe at the following annual rates: UK and Europe: £249 North America: Free Rest of the world: $249 subscription enquiries to subscriptions@rapidnews.com
Medical Plastics News is published by: Rapid Life Sciences Ltd, Carlton House, Sandpiper Way, Chester Business Park, Chester, CH4 9QE T: +44(0)1244 680222 F: +44(0)1244 671074 © 2017 Rapid Life Sciences Ltd While every attempt has been made to ensure that the information contained within this publication is accurate the publisher accepts no liability for information published in error, or for views expressed. All rights for Medical Plastics News are reserved. Reproduction in whole or in part without prior written permission from the publisher is strictly prohibited. ISSN No:
2047 - 4741 (Print) 2047 - 475X (Digital)
Crossing the line D
uring our annual team bout of end-of-year nostalgia we recalled a conversation two years ago about how the lines between the medical device, the pharma and the digital health sectors were becoming softer. This is an interesting time for the medtech and the medical device sectors, and those supplying them. Technologies are converging and we are seeing an increased use of connected technology in many devices; the adhesives market is showing positive growth signs thanks to the growth in sensors and digital health technologies; Industry 4.0 is impacting on the way manufacturing facilities operate, while the competitive landscape means device technology is advancing to create products that help us track and monitor conditions and our day-to-day health. We are also seeing a movement from manufacturing-led products to those driven by the needs of the healthcare sector and patients. The medical device and digital health sectors no longer sit apart and we are also seeing more interaction between these two markets and the pharma sector. Not only are devices becoming more sophisticated to accommodate new drug formulations but there is huge interest in the value of data surrounding adherence and tracking that the merging of these three life science sectors can provide.
An EY report has highlighted some key medtech findings through its Pulse of the Industry 2017 report: “In 2017, the industry demonstrates resilience and agility even as the pace of change accelerates on technological, reimbursement and regulatory fronts and new digitally based operating models shift power to consumers”. In the document, Klaus Schwab, founder and executive chairman of the World Economic Forum, describes how a “blurring [of] the lines between the physical, digital and biological spheres” is altering “business models, as decision-making power shifts away from manufacturers to other health care stakeholders.” How these industries work in tandem will be interesting. The report pinpoints key findings of 2017 – the rise in net income for the medtech sector in the US and Europe was up by 17%, and that the year saw the three biggest medtech deals since EY began its reporting, one of which was an $800million round raised by Verily, the life science subsidiary of Alphabet, formerly Google. Given this and the fact that Verily has tied up with Sanofi for the creation of Onduo, a diabetes platform, as well as with Johnson & Johnson for robotics and visualization company Verb Surgical, the trend for collaboration on a large scale is evident.
WWW.MEDICALPLASTICSNEWS.COM
“
We are also seeing a movement from manufacturingled products to those driven by the needs of the healthcare sector and patients
3
NEWS FOCUS
www.evonik.com/resomer
How can medical device manufacturers deliver future innovation in medtech?
T
he medical device sector is an integral part of the healthcare industry, and has seen an unprecedented growth in innovative and improved technologies that deliver benefits such as reduced patient Roger Mazzella, Qt recovery time, lower cost of instruments, and Company discusses more. The Internet of Things (IoT) is one of those developing and technologies – and Gartner predicts that 8.4 billion connected things will be in use worldwide regulating innovative in 2017, and that total spending on endpoints medical technologies and services will reach almost $2 trillion this of the future year. Meanwhile, the Internet of Medical Things (IoMT) market, an emerging sub-sector of the IoT, stood at $22.5 billion in 2016, and is expected to grow at an impressive compound annual growth rate of 26.2% to reach $72 billion by 2021, per analyst and research firm Frost & Sullivan. The development of medical devices and accompanying technologies takes time and money, as many innovative products are new and need to go through the rigors of incountry certification and market clearance processes. These devices, such as the latest iterations of pacemakers, insulin pumps and blood pressure monitors, will eventually come into contact with patients and sensitive information – and, in severe cases, life-or-death situations – on a daily basis. As a result, there are regulations and processes to ensure these technologies reach consumers only after passing a rigorous battery of clinical trials – which is why healthcare is the second-most regulated industry around the world (aviation is number one). However, new developments and the continued rise of new technologies like the IoMT have created more challenges than ever for medical device developers, bringing issues
such as cybersecurity and data integrity to the forefront. Looking ahead, what can be done to keep the health and well-being of patients the top priority? In the United States and the European Union (EU), strict compliance with regulations and guidance is a current solution, and many organizations (government, public and private) work together to make this happen. For example, the Advanced Medical Technology Association (AdvaMed) is a trade association that leads the effort to advance medical technology to achieve healthier lives and healthier economies around the world. The Massachusetts Medical Device Industry Council (MassMEDIC) is an organization of medical device manufacturers, suppliers and associated non-profit groups in Massachusetts and the surrounding region. AdvaMed and MassMEDIC work closely with national and international organizations such as the US. Food and Drug Administration (FDA) and the EU to advocate and promote policies directly from the medical community. AdvaMed is currently involved with the FDA’s Digital Health Precertification (PreCert) Pilot Program. The impetus for this program is the fact that traditional regulatory processes for high-risk medical devices are slow and methodical. With the help of AdvaMed advisors, however, the FDA realized that this traditional regulatory approach for higher-risk, hardware-based medical devices is not well-suited for software products. Software evolves faster than hardware, and therefore has a more iterative design, development and validation cycle. The FDA PreCert Program will help better regulate these technologies by learning, adapting and adjusting key elements in real-time. The goal: to allow software iterations and changes to occur in a timely fashion, and ensure high quality medical products and software. The IoMT is another new development that will impact the industry as a whole. Due to the requirements of this ecosystem, there are specific considerations, including cybersecurity and data integrity, that organizations such as medical device manufacturers should make – otherwise they not only could lose out on business opportunities, but could also put their customers at risk. To accommodate these considerations, the software powering medical devices has become more complex, hence the need for initiatives such as the FDA PreCert Program. The medical industry is evolving rapidly, and Qt is at the forefront of industry professionals who aim to influence the direction of technology innovation, as well as the standards and requirements that govern the sector on every level: local, state, national and global.
WWW.MEDICALPLASTICSNEWS.COM
5
NEWS FOCUS
www.evonik.com/resomer
UDI compliance: Where are we?
N
Warren Stacey, PRISYM ID looks at best practice for UDI compliance and offers an examination of UDI implementation to date
early four years after the FDA set out its framework for establishing a unique device identification system to identify medical devices through their distribution and use, implementation is well over halfway and there is little time remaining before its compulsory introduction. The system means that by 2020 most medical devices will need to include a Unique Device Identifier (UDI) in human and machinereadable form. In addition, device labellers must submit mandatory data about each device to the FDA/National Library of Medicine’s Global Unique Device Identification Database (GUDID), enabling the public and healthcare stakeholders to access and download device information. The implications for medical device companies are significant. Assuring
UDI compliance requires a major review not only of an organisation’s labelling capabilities but also how it connects with all the other divisions that impact supply chain operations. Furthermore, the journey towards UDI compliance requires an enterprise-wide program of change management to ensure the requisite infrastructure is in place. It’s a journey that for many manufacturers has proved to be a challenging one. UDI: Its meaning & purpose? The FDA’s introduction of the UDI system has a number of goals: To drive more accurate reporting and analysis of adverse events, ensuring problem devices can be quickly identified and rectified To reduce medical errors by giving healthcare professionals key information about specific devices To enhance market analysis with access to real-world data on device usage
To provide a standard identifier to help manufacturers, distributors and healthcare providers to manage product recalls efficiently The FDA’s definition of a UDI and its guidelines are complex and mean that, for many companies, managing the transition to UDI compliance can be a challenging process. Critically, the implications for labelling operations are significant and require all medical device manufacturers to examine their current infrastructure and, in many cases, adapt it to enable more holistic label lifecycle management. Labelling at the center A survey conducted last year by PRISYM ID highlighted that UDI implementation caused reverberations in manufacturing, quality, operations and distribution. Likewise, UDI projects also tend to involve IT and regulatory teams, meaning that they permeate almost every department and system within an organisation. This naturally dictates a collaborative approach where implementation decisions cannot be made or managed in isolation. However, the biggest impact of UDI implementation is typically felt in labelling and packaging. 85% of respondents reported that labelling, packaging & design were affected the most. This is further underlined by data which reveals that companies experienced more issues around their labelling capabilities than any other area. Building and implementing an appropriate labelling system was cited as the single biggest issue, with 23% of respondents encountering difficulties. Alongside this, almost a fifth (19%) found getting a UDI onto the device label was their biggest challenge, while 9% reported issues adding a UDI
WWW.MEDICALPLASTICSNEWS.COM
to device packaging. This data shows that, when asked to name their biggest issue around UDI compliance, more than half of all respondents cited issues related to labelling. Making the move to UDI compliance requires manufacturers to ensure device labels not only include a device identifier (DI), production identifier (PI) and associated barcodes, but also include 13 additional pieces of information. These requirements represent a major shift and necessitate a labelling system that can capture these data sets accurately and efficiently and configure them to the appropriate label design. Ideally, the labelling system would be able to communicate seamlessly with systems that support the submission of data to GUDID. This separate process requires the submission of data covering a total of 62 fields – with data not only coming from the label itself but from various locations right across the organisation. Conclusion It’s therefore no surprise that medical device companies are increasingly looking to improve their labelling systems to ensure operations are UDI compliant. There is a growing trend towards the implementation of ‘vision’ systems that automate label inspection, post-print. With more than half of all survey respondents citing label-related issues as the biggest challenge in the journey towards UDI implementation, it makes sense for the remaining medical device manufacturers who have yet to implement UDI to ensure they have the optimal labelling solution in place as they approach the final 2020 FDA deadline.
7
www.evonik.com/resomer
DIGITAL
DIGITAL NEWS
spy
www.evaluategroup.com GLOBAL MEDTECH SALES
TECHNOLOGY UPDATE
TIPPED TO HIT $522 BILLION BY 2022
www.washington.edu Long distance love:How low power devices can achieve long-range communication
U
niversity of Washington researchers have demonstrated for the first time that devices that run on almost zero power can transmit data across distances of up to 2.8 kilometers — breaking a long-held barrier and potentially enabling a vast array of interconnected devices. For example, flexible electronics — from knee patches that capture range of motion in arthritic patients to patches that use sweat to detect fatigue in athletes or soldiers — hold great promise for collecting medically relevant data. But today’s flexible electronics and other sensors that can’t employ bulky batteries and need to operate with very low power typically can’t communicate with other devices more than a few feet or meters away. This limits their practical use in applications ranging including medical monitoring. By contrast, the UW’s longrange backscatter system, which uses reflected radio signals to transmit data at extremely low power and low cost, achieved reliable
coverage throughout 4800-square-foot house, an office area covering 41 rooms and a one-acre vegetable farm. “Until now, devices that can communicate over long distances have consumed a lot of power. The trade-off in a low-power device that consumes microwatts of power is that its communication range is short,” said Shyam Gollakota, lead faculty and associate professor in the Paul G. Allen School of Computer Science & Engineering. “Now we’ve shown that we can offer both, which will be pretty game-changing for a lot of different industries and applications.” The sensors are cheap — with an expected bulk cost of 10 to 20 cents each. “This is the first wireless system that can inject connectivity into any device with very minimal cost,” said Vamsi Talla, CTO of Jeeva Wireless, a spin-out company founded by the UW team of computer scientists and electrical engineers, which will be looking after commercializing the technology.
T
he EvaluateMedTech World Preview 2017, Outlook to 2022 report from life science intelligence firm Evaluate, reveals Medtronic was the leading medtech company in 2016 with sales of almost $30bn and will retain the crown in 2022 with sales forecast to reach $37.7bn; Abbott jumps to 3rd place as its acquisition of St. Jude creates the world’s second largest cardiology company. “After a slow year in 2016 as companies that had made large buys the year before paused to digest their purchases, M&A activity is once again on the up. At nearly $50bn, the total value of mergers closed in the first half of 2017 has already eclipsed the total for all of 2016”, said Elizabeth Cairns, report author. “Despite this the number of deals struck has been falling; mergers are getting bigger, but also scarcer”, she added.
DIGITAL UPDATE
Random act of kindness: Charity set up to offer free prosthetics
www.parisschools.org/o/district
I
n Arkansas, Paris High School students Anna Claire Richey and Joni Inman have created a charity which they are hoping will change lives.
With the relevant approvals the girls will make more products to provide free of charge to patients in the US. and 45 other countries, who cannot afford a traditional prosthesis.
Give Me Five, will 3D print parts for prosthetic arms, hands and fingers, thanks to its partnership with a software company. These will be given away.
Each hand will cost Give Me Five $75 to make. A typical, medical prosthetic hand costs around $11,000. The eventual goal, is to produce 10 to 15 prosthetics each year.
The girls recently made parts for and assembled their first prototype hand for inspection and approval by the software company. The prosthetic hand, which is fully articulate, took 28 hours to print and seven hours to assemble.
8
REPORT HIGHLIGHTS: • Total value of medtech M&A deals rises by 178% in 2017 • In vitro diagnostics is expected to remain the largest medtech segment in 2022 with annual sales of $70bn; Roche remains top player with expected sales of $12.8bn in 2022 • Global medtech R&D spend set to grow by 3.7% (CAGR) to $33.5bn by 2022
WWW.MEDICALPLASTICSNEWS.COM
“We hope that by doing this, we can enable people to reach their full potential,” RIchey said. Anyone interested in making donations to Give Me Five can make contact at richeyenable@gmail.com
DIGITAL SPY
DIGITAL UPDATE www.frogdesign.com
New for old: Medical device partners wanted for redesigned speculum prototype
talking
POINT
cranking” (female readers will know all about this). The website recounts how the redesign came about following two of Frog’s team attending pap smears. Designer Sahana Kumar outlined how she wanted to “humanize the whole experience,” so kick-started a project that enlisted the help of female employees, patients and healthcare professionals.
T
hanks to a case of girl power at San Francisco-based company Frog, the good old speculum may be about to get an overhaul. And the company behind it is looking for a medical device partner. According to Fortune, designers at the firm have attempted to “reimagine the unimaginative medical device—turning it into a form factor that doesn’t involve any
Invented in the 19th century, the medical device hasn’t had much of a revamp since then. The Frog team have given the product a push handle that opens up in a leaf-life manner to expand inside the vagina as well as coating it in surgical silicone to warm up the procedure a bit more. The device is still at prototype stage and is looking for a medical device company to partner with and manufacture the product.
DIGITAL BREAKTHROUGH
DELIVERY SERVICE:
Medical device offers alternative drug delivery route
T
he Enable injector is a safe, simple, and discreet drug delivery device that aims to provide a controlled and comfortable flow of drug at a rate that adapts to the user. The injector design is based on over 12 years of research in minimizing injection pain with numerous human factors studies conducted. Easy to use, the injector sticks onto the skin and once the safety tab has been removed, with the push of a button, the needle is automatically inserted in to the skin for controlled delivery of a drug.
Removal is designed to be just as easy with the needle automatically retracting and locking out. The award-winning company behind the device, Enable Injections, has teamed up with Flex to create the Enable Smart Device. This uses Bluetooth technology and allows integration with Enable’s pharma partners access patient data across multiple devices, for more direct engagement with patients to drive adherence.
Into the Abyss: SMART TATOO MEDICAL DEVICE THAT KEEPS A CHECK ON YOUR HEALTH So how does this work? The Dermal Abyss tattoo changes color according to the health of the wearer. It can show when someone is dehydrated or if their blood sugar is too high. Developed in a joint project by the MIT and Harvard, the tattoo monitors the body’s interstitial fluid, with the ink changing from green to brown when glucose levels increase. To reflect dehydration the team has also developed a green ink that grows more intense as sodium concentration rises. Who’s behind the device? The tattoo was developed by two postdoctoral fellows at Harvard Medical School and colleagues led by Katia Vega at MIT’s Media Lab. The team tattooed the inks onto pig skin and observed how the color changed. Why? The tattoos were developed as a way to overcome some of the limitations of current monitoring devices. Ali Yetisen, a postdoctoral fellow Harvard Medical School said: “We were thinking: New technologies, what is the next generation after wearables? And so we came up with the idea that we could incorporate biosensors in the skin.” The team said that current wearables don’t seamlessly integrate with the body, and face other issues such as short battery life and the need for wireless connectivity. “We wanted to go beyond what is available through wearables today,” Yetisen continued. What can the tattoo be used for? Applications could see the tattoos being used to monitor chronic conditions and could be used with astronauts, as they require continuous health monitoring. The team has also developed an app that can analyse a picture of a sensor and provide quantitative diagnostic results.
WWW.MEDICALPLASTICSNEWS.COM
9
Setting the beat in medical technology, education, and innovation
Find your rhythm at this year’s event
■
■
■
Find solutions to your challenges with innovative medical technologies and products Network with peers to discover insights and start collaborations Learn how to move your projects forward through education and training
November 8-9, 2017 Minneapolis Convention Center Minneapolis. MN
To learn more visit MDMminn.com/MPN Use promo code MINN for a free expo pass
34722_MN_MDM17
LAB-ON-A CHIP
www.evonik.com/resomer
Chip shot Despite suggestions that the FDA isn’t interested in lab-on-a-chip technology, advancements in this field are showing increasing potential for the healthcare sector, says Lu Rahman
E
arlier this year Spectator Health ran the headline, This ‘lab on a chip’ knows when you’re ill before you do. Will the regulators approve it? The piece by Benedict Spence focussed on the fact that scientists from Rutgers University claim that health issues could be identified through the analysis of blood and sweat using a labon-a-chip. According to Spence, the device is small enough to fit in a wearable device and is able to detect the biomarkers of various diseases with 95% accuracy – this, says the developers, will increase to 100% in a short space of time. However, Spence believes that FDA regulators won’t allow the device to be sold to the public as putting its approval stamp on ‘consumer health monitoring technology’ throws up problematic issues such as data protection and misdiagnosis. Despite this, the development of lab-on-a-chip devices is advancing. Harvard’s Wyss Institute recently launched the human Organ Chip project to mimic human influenza infection and pathogenesis in vitro, and identify new drug leads that target host response factors. COLOR RUN: Demonstration of concentration gradient in microfluidic system using red and blue color dye solutions. (Purdue University photo)
The development of anti-influenza drugs has been limited by the fact that animal models do not accurately reflect the infection mechanisms influenza viruses engage in humans. The Wyss Institute’s team will use lung small airway and alveolus chip devices lined by living human lung cells that they previously showed to reproduce normal lung physiology as well as diseases that affect these regions, including chronic obstructive pulmonary disease (COPD), asthma and pulmonary edema. The lung chips are microengineered devices the size of a computer memory stick that contain two parallel hollow channels, each less than 1mm wide, separated by a porous membrane. Lung alveolar cells are cultured on the porous membrane in one channel, and lung capillary endothelial cells are grown on the opposite side of the same membrane in the second channel to recreate the characteristic tissue-tissue interface found within these lung regions. With air streaming through the lung epithelial channels and growth medium continuously streaming through the ‘vascular channels’, the team can maintain, study and manipulate the re-engineered organ units over the course of weeks to months. “Virtually all existing anti-viral drugs target the virus itself, however, the ability to study influenza infection in human lung chips also allows us to study the host response to infection in a highly controlled way,” said Donald Ingber, principal investigator (PI) and Wyss founding director. Meanwhile researchers at Purdue University are creating a device that they hope will help identify risk factors that cause breast cancer. The device, known as risk-on-a-chip, is a small plastic case with several thin layers and an opening for a piece of paper where researchers can place a portion of tissue. This tiny environment
WWW.MEDICALPLASTICSNEWS.COM
produces risk factors for cancer and mimics what happens in a living organism. “We want to be able to understand how cancer starts so that we can prevent it,” said Sophie Lelièvre, a professor of cancer pharmacology at Purdue. Cancer is a disease of gene expression, and organisation of genes is specific to a particular species and organ, which means it wouldn’t be useful to perform this study on rats or mice. Lelièvre needs a model that will mimic the organ in question. She teamed up with Babak Ziaie, a professor of electrical and computer engineering at Purdue, to create the device. The risk-on-a-chip is based on an earlier cell culture device developed by Lelièvre and Ziaie to study cancer progression. To modify it for prevention, Ziaie plans to add nanosensors that measure two risk factors: oxidative stress and tissue stiffness. Oxidative stress occurs as the result of diet, alcohol consumption, smoking or other stressors, and alters the genome of the breast, aiding cancer development. The risk-on-a-chip will simulate oxidative stress by producing those molecules in a cell culture system that mimics the breast ducts where cancer starts. Tissue stiffness has been found to contribute to onset and progression of breast cancer. The team will measure stiffness within a tunable matrix made of fibres, whose density is relative to stiffness. Whatever the FDA’s long term approach to these products may be, their potential in the advancement of knowledge and treatment and detection of illness is clear. Conditions such as breast cancer are difficult to prevent due to multiple risk factors working independently. However, research work being carried out at this level may one day help to change that.
11
COVER STORY
T
oday’s medical tubing market is oriented toward tubing that is smaller (less invasive) with tighter tolerances and higher overall quality. Processors also need to be able to run at higher line speeds to improve efficiencies and cost competitiveness. While this creates a challenging climate for equipment manufacturers and system integrators, Davis-Standard has excelled in meeting industry demand head-on in terms of providing adaptable equipment solutions and extensive R&D capabilities. Davis-Standard’s track record in medical tubing is reflected in the company’s global installations and growing market share. It is a key player in medical tubing equipment in the United States and has experienced a steady and consistent increase in overseas markets. Machinery, feedscrew and control options are available for nearly every medical tubing application including catheters, drainage and IV tubing, microbore tubing, radio opaque tubing, taper tubing and many others. Paramount to this versatility is the fact that the company’s equipment can be designed to accommodate a range of materials ranging from polyolefins, FPVC and nylons to PLA, PLLA, PEEK and FEP. The business is always working alongside customers to develop new applications, including innovative tubing processes that integrate Davis-Standard’s patented Alternate Polymer technology. This is complimented by its commitment to fast response times, spare parts inventory and aftermarket service. “We are poised to take advantage of future medical tubing opportunities through continual development and unconventional solutions for complex products,
12
engineered with features that surpass those of other extrusion equipment suppliers,” said Kevin Dipollino, product manager of Davis-Standard’s Pipe, Profile and Tubing Systems. “We currently support a much higher degree of vertical integration than our competitors, which translates into a better overall experience for customers. Customers may perceive Davis-Standard as a large company. However, our tubing group operates as a small dedicated team, committed to customer needs. We have our own in-house engineering team, encompassing mechanical, electrical and software design. We also have the best lab and process engineers in the industry.” According to Dipollino, the availability of R&D processing labs is a significant advantage for DavisStandard customers. The company has its principal medical tubing lab at its headquarters in Pawcatuck and a secondary lab in China at its subsidiary in Suzhou, Davis-Standard (Suzhou) Plastic Packaging Machinery Co. The medical tubing line in Connecticut is located in a climate-controlled cleanroom type WWW.MEDICALPLASTICSNEWS.COM
COVER STORY
On repeat Davis-Standard is known for its medical tubing expertise. The company explains how it stays at the top of the field through perpetual innovation
environment for customers to test new resins, make parts for proof-of-concept, and conduct R&D trials prior to making large capital equipment investments. Examples of current machinery innovations include tight tolerance processing of FEP tubing with radio opaque stripes, the MEDD (Medical Extruder Direct Drive) extruder, and the Alternate Polymer technology. The FEP line is ideal for medical applications requiring biocompatibility and lubricity. The compact MEDD is optimized for cleanroom environments with a replaceable feed section liner and direct drive technology for greater efficiency and materials flexibility. Davis-Standard offers a high-tech melt pump system to maximize stability when processing sensitive materials. With Alternate Polymer technology, processors can switch from polymer A to polymer B using precision extruders and melt pumps with highly accurate servo drives to toggle between resins.
Twice as good: Davis-Standard’s lab in Suzhou, China, offers customers another R&D option for medical tubing development
“With continued growth in the medical tubing market worldwide, our R&D lab lines have been an extremely important asset for both Davis-Standard and our customers. These lab lines have also supported our efforts to stay ahead of the game and bring competitive solutions to the industry,” said Dipollino.
We currently support a much higher degree of vertical integration than our competitors
WWW.MEDICALPLASTICSNEWS.COM
As for the future, Dipollino and his team at DavisStandard are optimistic. The company has seen substantial growth for medical devices in the Asia Pacific market, as medical treatments align with those in the US and Europe. Dipollino pointed out that global demand for medical tubing will remain strong due to aging populations and increased awareness regarding quality of care and patient safety. An example of a niche market that Davis-Standard has capitalized on is equipment for processing radio opaque tubing for catheters. This highly-specialized technique is one in which Davis-Standard has quickly become the market leader. Dipollino also noted the company has a strong pipeline of projects and is expecting to finalize key partnerships with medical companies that will support a strong finish to 2017 and future expansion.
13
The essential information source for anyone involved in design, manufacture and supply of medical plastics devices.
Subscribe to the MPN app
and get INSTANT access to the latest content and back editions for free.
Wherever you are Whatever your device Intelligence at your fingertips
MERGERS & ACQUISITIONS
www.evonik.com/resomer
DEAL OR NO DEAL M&A activity in the medtech sector is going strong. Lu Rahman looks at some of the recent deals taking place in the industry
E
arly this year Matt Robida, Spectrum Plastics Group, explained to MPN Europe magazine how the company’s recent merger highlighted the trend for medical consolidation. Pexco, the Georgia-based specialty extrusion and custom plastics company with a growing position in medical plastics, and Kelpac Medical, the Wisconsin-based medical tubing manufacturer, merged and rebranded as Spectrum Plastics Group. According to Robida, the merger “illustrates how the effects of consolidation at the major company level are impacting the supply chain. The highly fragmented $25 billion US medical contract manufacturing and outsourcing market, of which 40% is spent on plastics and which is estimated to be growing near 10% per year through 2020, is beginning to show the same signs of consolidation that the majors have been witnessing”. He added that private equity firms and investment buyers, which annually are quite active in plastics manufacturing, as well as private or public Industrial strategic buyers, wishing to get in on the medical growth game, have been participating in and exacerbating this supply chain consolidation trend. Deals between high calibre medtech companies within the supply chain continue to create interest within the sector. Elizabeth Cairns, author of the EvaluateMedTech World Preview 2017, Outlook to 2022 summed up M&A movement in recent years: “After a slow year in 2016 as
companies that had made large buys the year before paused to digest their purchases, M&A activity is once again on the up. At nearly $50bn, the total value of mergers closed in the first half of 2017 has already eclipsed the total for all of 2016. Despite this the number of deals struck has been falling; mergers are getting bigger, but also scarcer”. Last year major drug delivery player PhillipsMedisize announced the acquisition of Medicom Innovation Partner of Denmark and its subsidiary in Cambridge, UK. Medicom specializes in connected health drug delivery devices and employs a staff of 90 specialists in Denmark and the UK. This means that Phillips-Medisize now employs about 500 engineers throughout its global design and development network to develop injectable and inhalation devices for the global market. Following this Phillips-Medisize itself was the subject of an acquisition when global manufacturer of connectors and interconnectors, Molex, bought the company. Martin Slark, chief executive officer of Molex said: “Phillips-Medisize brings strong capabilities to Molex in the medical solutions market globally. Combining Molex’s expertise in electronics and our broad manufacturing presence with Phillips-Medisize’s talented and experienced team will help us better serve the growing needs of the global market for innovative connected health solutions.” According to Robida, thanks to “continued globalization and higher demand for medical technology and services, medical OEMs are diversifying their product portfolio, scaleup operations and gaining market share to improve their negotiating power with hospital systems and the demands of a value-based healthcare model.”
Polish Grizzly Medical, which is involved in the assembly, post-processing and quality assurance of medical device components and systems. The company has been a supplier to and partner of Nolato Medical since the 1990s. Providing a route into or to strengthen a particular market can of course be a key driving force. Nelipak’s purchase of thermoforming company Computer Designs Incorporated – operating under the name Nelipak Healthcare Packaging – means that the business can strengthen its commitment to the North American healthcare market. DePuy Synthes Products, part of Johnson & Johnson Medical Devices Companies recently acquired Innovative Surgical Solutions (Sentio). According to DePuy Synthes the acquisition underscores the business’ strategy of investing in what it describes as “faster growing segments with technologies that are designed to help improve patient outcomes and bring value to our customers”. DePuy Synthes has also splashed out on 3D printing technology from Tissue Regeneration Systems (TRS). TRS’ 3D printing methods will help enable the company to create patient-specific, bioresorbable implants with a mineral coating intended to support bone healing. Depuy Synthes says the acquisition brings exciting new technology with the potential to personalise healthcare solutions in trauma. M&A activity in the medtech sector doesn’t seem to be showing any signs of disappearing. It will be interesting to see how this bears out in 2018 and how this consolidation will affect the medical technology supply chain going forward.
Bolstering a company’s offering to the market is often a key factor in the decisionmaking process. Nolato recently acquired
WWW.MEDICALPLASTICSNEWS.COM
15
Winning moment Lu Rahman picks some of the stand-out moments and businesses of 2017
T
he medical device sector is filled with innovative characters and companies. From research to the development and manufacture of new materials, technology and devices, the industry is on a constant quest to improve techniques and processes while maintaining a competitive edge within the production of products that offer health benefits to millions of people globally. The public face of the industry is one in which many of us have a keen interest. Scott Whittaker, AdvaMed, is a prolific voice in the industry. Seen as a leading voice of the medtech world, Whittaker is recognised as a top health care advocate and policy expert with experience across multiple health policy sectors. One of the most significant faces at the moment is of course, Scott Gottlieb, FDA commissioner. With a background in investment, as well as a stint as a consultant to the drug industry, Gottlieb’s appointment was criticised due to his links with the pharma sector. There was however, another school of thought which felt his experience with this industry would be advantageous in the new role. Research Universities and research institutes are a great source of content for the MPN team. Earlier this year scientists at MIT, Massachusetts General Hospital, biomaterial research group Olivio Labs, revealed how they had developed a wearable, siliconebased material that not only could
16
offer the secret to eternal youth by tightening the skin to smooth out wrinkles, but could also have potential as a drug delivery system. Working with biotech business Living Proof, the group has come up with a material that is said to be able to boost skin hydration as well as providing UV protection. Meanwhile at the Wyss Institute for Biologically Inspired Engineering, a team created selfhealing slippery surface coatings with medical-grade Teflon materials and liquids that prevent biofilm formation on medical implants while preserving normal innate immune responses against pathogenic bacteria. The technology is based on the concept of ‘slippers liquidinfused’ porous surfaces’(SLIPS) developed by Aizenberg. Inspired by the Nepenthes pitcher plant, which uses the porous surface of its leaves to immobilise a layer of liquid water, creating a slippery surface for capturing insects, Aizenberg engineered industrial coatings that can repel unwanted substances. One of my favourite technologies at the moment has to be soft robotics. Earlier this year Harvard University and Boston Children’s Hospital revealed some exciting work involving a customizable soft robot that fits around a heart to help it beat. The research has huge implications for anyone who has suffered heart failure. According to Harvard, the soft robotic sleeve, “twists and
compresses in synch with a beating heart, augmenting cardiovascular functions weakened by heart failure. Unlike currently available devices that assist heart function, Harvard’s soft robotic sleeve does not directly contact blood. This reduces the risk of clotting and eliminates the need for a patient to take potentially dangerous blood thinner medications. The device may one day be able to bridge a patient to transplant or to aid in cardiac rehabilitation and recovery.” The device is attached to a pump that uses air to power soft actuators. Each sleeve can be customized for each patient and according to for example, the side of their heart where more power is needed. “This work represents an exciting proof of concept result for this soft robot, demonstrating that it can safely interact with soft tissue and lead to improvements in cardiac function. We envision many other future applications where such devices can deliver mechanotherapy both inside and outside of the body,” said Conor Walsh, senior author of the paper and the John L Loeb associate professor of engineering and applied sciences
WWW.MEDICALPLASTICSNEWS.COM
MOVERS & SHAKERS
INVIBIO
VENTION MEDICAL It’s great to hear how companies are innovations and using technology in the medical plastics space. Vention Medical recently explained to MPN how embracing digital innovation in sourcing extrusions have helped design engineers to get products to market faster. The company’s Katie Karmelek explained that thanks to these innovations, the quality of early prototypes has been improved, there has been a reduction in the need to retest materials later in the process and generally product development has accelerated. She says that the three things that have contributed to this are online access to medical-grade stock tubing, rapid extrusion digital design tools, and quickturn custom extrusions.
ACCUMOLD A key player in the micromolding sector, Accumold has enjoyed a range of success in the sector in recent years. At the start of 2017 it reported 100 new team members and that it was looking to reach 450 employees in the next 12-18 months. The company’s innovation team has recently been expanding its micro-molder capabilities by enhancing its insert / overmolding molding expertise. It says that the ability to overmold very delicate media like glass, fabrics or other very expensive inserts is in high demand. According to Aaron Johnson, vice president marketing, Accumold: “We are deeply committed to three things – capability, scalability, and sustainability. We have worked hard to provide the most innovative micro molding capabilities we can. We know it can’t just stop there. In today’s manufacturing world there is little room, if any, for disruption. That’s why building an organisation that can grow with our customers and sustain the years to come is as important as the molding capabilities themselves. We’ve tripled our facility in the last five years. Our latest addition is a hardened structure designed with dedicated resources to provide assurance of supply. We believe our customers need to know they can rest assured when they partner with Accumold - their future is ours too.”
WWW.MEDICALPLASTICSNEWS.COM
CLARIANT
Organisations
HEAD BOY: The appointment of Scott Gottlieb as FDA commissioner was a significant event in 2017
We’re always keen to hear news about materials on MPN which was why I liked this piece about the congress of the Chinese Association of Orthopaedic Surgeons (CAOS), Invibio Biomaterial Solutions of the UK, and China’s Double Medical Technology collaborated on an interbody spine surgery workshop to help expand knowledge of the implantation of Double Medical’s Direct Lateral Interbody Fusion (DLIF) spinal cages made with PEEKOptima. The biomaterial PEEK-Optima polymer by Invibio was introduced to medical device manufacturers in China after the approval by the China Federal Drug Administration (CFDA) in 2004. Hosted in conjunction with the North American Spine Society (NASS), the CAOS workshop “Principles and Techniques of Complex Spine Surgery Workshop” took place in May in Guangzhou. The event was the fifth joint NASS-CAOS workshop and delivered a day of handson cadaver labs with over one hundred surgeons attending and multiple one-hour product demonstrations streamed live to the audience, including the demonstration of Double Medical and medical-grade PEEK innovator Invibio. “The design of this state-ofthe-art DLIF cage incorporates advances in medical technology contributed by both our companies,” commented Michael Veldman, global strategic marketing manager at Invibio.
Clariant is doing some really interesting work to combat counterfeiting. Counterfeit medical products pose a serious threat to the health of patients worldwide, as well as to the brand recognition of medical device manufacturers. The company has teamed up with security provider SICPA to help fight the counterfeiting epidemic with its collaborative system Plastiward. Plastiward works by using proprietary taggants developed by SICPA which are delivered to Clariant’s Mevopur production plants. The taggants are then embedded into polymers used in medical devices and pharmaceutical packaging where they can be monitored in real-time using SICPA’s deployment and monitoring platform. Steve Duckworth, head of global healthcare, polymer solutions, at Clariant said: “The quicker you can authenticate the quicker you can get realtime data and the quicker you can take action. One of the major advantages you see from the Plastiward system is you’re able to go into a warehouse to detect any issues and back in the HQ you’re able to see in real-time where the problem has occurred, and then take action.”
17
Introducing the North American edition of
MEDICAL PLASTICS news SUBSCRIBE TODAY FREE ACROSS NORTH AMERICA
ADVANCING MEDICAL PLASTICS
The essential information source for anyone involved in design, manufacture and supply of medical plastics devices. Through opinion, analysis and thought leadership, we engage and connect our community with information on materials, medical advancement and manufacturing processes. Our expert editorial team will keep you at the forefront of an industry that’s crucial to advancing healthcare internationally. To subscribe visit our website to receive your weekly newsletter and quarterly print magazine.
www.medicalplasticsnews.com @MPN_Magazine
available at
SOFT ROBOTICS
Walking the walk Soft robotics help post-stroke patients walk
Benjamin Boettner explains how post-stroke patients reach terra firma with Wyss Institute’s soft robotic exosuit technology A soft wearable robotic suit is promoting normal walking in stroke patients, opening new approaches to gait retraining and rehabilitation. Upright walking on two legs is a defining trait in humans. This can all change when a stroke occurs. In about 80% of patients’ post-stroke, it is typical that one limb loses its ability to function normally - a clinical phenomenon called hemiparesis. And even patients who recover walking mobility during rehabilitation retain abnormalities in their gait that hinder them from participating in many activities, pose risks of falls, and, because they impose a more sedentary lifestyle, can lead to secondary health problems. To help stroke patients regain their walking abilities, various robotics groups from industry and academia are developing powered wearable devices – exoskeletons – that can restore gait functions or assist with rehabilitation. Historically, these systems restricted patients to a treadmill in a clinical setting, but in recent years portable systems have been developed that enable walking overground. Working towards the long-term goal of developing soft wearable robots that can be worn as clothing, researchers at the Wyss Institute for Biologically
Inspired Engineering, the Harvard John A. Paulson School of Engineering and Applied Sciences (SEAS) and Boston University’s (BU) College of Health & Rehabilitation Sciences: Sargent College have developed a lightweight, soft, wearable ankle-assisting exosuit that could help reinforce normal gait in people with hemiparesis after stroke. In a new study published in Science Translational Medicine, a research team led by Conor Walsh collaborating with BU faculty members Terry Ellis, Lou Awad, and Ken Holt have demonstrated that exosuits also can be used to improve walking after stroke - a critical step in de-risking exosuit technology towards real-world clinical use. “This foundational study shows that soft wearable robots can have significant positive impact on gait functions in patients post-stroke, and it is the result of a translationalfocused multidisciplinary team of engineers, designers, biomechanists, physical therapists and most importantly patients who volunteered for this study and gave valuable feedback that guided our research,” said Wyss Core Faculty member Walsh, who is also the John
L. Loeb Associate Professor of Engineering and Applied Sciences at SEAS and the Founder of the Harvard Biodesign Lab. Patients recovering from a stroke develop compensatory walking strategies to deal with their inability to clear the ground with their affected limb and to ‘push off ’ at the ankle during forward movement. Typically, they have to lift their hips (hip hiking) or move their foot in an outward circle forward (circumduction) rather than in a straight line during walking. Usually, rigid plastic braces worn around the ankle are prescribed to help with walking, but they do not help overcome these abnormal gait patterns and about 85% of people who suffered a stroke retain elements of their gait abnormalities. “Current approaches to rehabilitation fall short and do not restore the mobility that is required for normal life,” said Ellis, director of the Center for Neurorehabilitation at BU’s College of Health & Rehabilitation Sciences: Sargent College and Assistant Professor at BU. In the new study, the team asked whether the exosuit’s beneficial impact on gait mechanics and energy expenditure during walking they observed in
WWW.MEDICALPLASTICSNEWS.COM
healthy people would also be observed in patients poststroke who were recruited and enrolled in the study with the help of the Wyss Institute’s Clinical Research Team. Exosuits are anchored to the affected limb of a hemiparetic stroke patient via functional apparel, and they provide gaitrestoring forces to the ankle joint by transferring mechanical power via a cable-based transmission from batterypowered actuators that are integrated into a hip belt or an off-board cart located next to a treadmill. “Indeed, in treadmill experiments we found that a powered exosuit improved the walking performance of seven post-stroke patients, helping them to clear the ground and push off at the ankle, thus generating more forward propulsion,” said Jaehyun Bae, a co-first author on the study and graduate student at SEAS.. Because walking mechanics and dynamics differ between controlled walking on a treadmill and walking overground in the home or communal environment, the team went on to assess exosuit-provided benefits in an overground walking experiment.
19
M
edical device manufacturers are challenged to design, develop, and manufacture products which enable the production of innovative therapeutic solutions. In order to ensure the production of these therapeutic solutions, there are many important aspects that must be considered to help facilitate improved patient outcomes. These considerations include device design, material selection, processing, sterilisation, biological response, and end use environment. For this article, we will focus on material selection, namely bioresorbable polymers which are biocompatible materials that offer medical device companies flexibility in design and processing methods. What are bioresorbable polymers? Bioresorbable polymers are materials that are absorbed in the body after performing the desired therapeutic function. Implants produced with bioresorbable polymers are decomposed in the body by natural degradation pathways into water and carbon dioxide. There are two kinds of bioresorbable materials, biopolymers which are naturally derived and biopolyesters which are synthetically produced. Biopolyesters include for example polylactide (PLA) poly lactideco-D, L lactide (PLDL,) poly lactideco-glycolide (PLGA,) poly lactide-cocaprolactone (PLCL,) poly caprolactone (PCL) poly dioxanone (PDO,) and poly lactide-co-trimethylene carbonate (PLTMC). These biopolyesters are available as either amorphous or semi-crystalline polymers which provide a range in mechanical strength and degradation profile. Bioresorbable polymers provide the possibility to customize the level of crystallinity, hydrophilicity, molecular weight, and degradation profile of the polymers to further improve mechanical properties and biocompatibility. Typical applications Bioresorbable polymers have been successfully used in low load bearing applications due to their mechanical properties and degradation profiles. Some of the typical applications include sutures, rods, plates, screws, and scaffolds for tissue engineering. The possibility to fine tune these polymers based on targeted part performance requirements provide medical device manufacturers flexibility in design for optimal functionality in their device.
20
Disappearing Cranio-maxillo-facial (CMF) Poly L-lactide-co-D, L lactide (PDLLA) have good tensile strength, excellent mechanical and thermal properties and are used in various orthopedic applications including cranio-maxillofacial devices which are used to treat deformities in the head. Since most of these applications do not require the implant to be placed under an elevated mechanical load, bioresorbable materials used for these treatments have focused on enhancing the biological response and ability to promote healthy bone regeneration without causing any adverse side effects upon degradation. One of the design benefits of such implants made with bioresorbable materials is the possibility to shape the CMF plate to the desired geometry in the operating room using heat to ensure an ideal fit with the patient’s anatomy.
WWW.MEDICALPLASTICSNEWS.COM
Sutures and suture anchors Poly dioxanone (PDO) provides medical device manufacturers with a polymer that allows them to manufacture a device requiring flexibility, good mechanical properties, and fast to moderate degradation profile of 6 to 12 months. This material is ideal for sutures because it is able to hold regenerating tissue systems in place long enough to allow for full healing at which point the suture would degrade and be resorbed by the body. Polylactides (PLA,) poly L-lactideco-D, L lactide (PDLLA,) and poly lactideco-glycolide (PLGA) materials are options for producing suture anchors due to their mechanical properties and moderate degradation profile. Some medical device manufacturers also offer suture anchors made from a composite blend of bioresorbable polymers with calcium phosphate to enhance bone growth. Such implants help provide quality patient outcomes and improved patient satisfaction.
BIOABSORBABLE POLYMERS
APPLY AND DEMAND: Bioresorbable materials are used in implant applications as they help facilitate the healing process and eventually absorb within the body
Sabine Fleming, Evonik Health Care, Evonik, explains how medical device companies can use bioresorbable materials to develop devices which improve patient outcomes
world MATERIAL WORLD: Interference screws are used in reconstructive surgery. The mechanical properties of bioresorbable materials makes them a strong choice for these products
Interference screw Interference screws are used in reconstructive surgery of the anterior cruciate ligament (ACL) within the knee. For this particular application, the mechanical properties of bioresorbable materials as well as the ability to prolong the degradation time makes polylactide (PLA) poly(lactide-co-glycolide) (PLGA,) and poly(L-lactide-co-D, L lactide) (PDLLA) particularly advantageous material options. As with suture anchors the addition of calcium phosphate helps promote bone growth, while absorbing at a slow enough rate to allow proper functionality of the implant. This controlled degradation is beneficial for this application as the ingrowth of bone tissue into the interference screw region allows for the native tissue fixation of the implanted tendon to occur resulting in better patient outcomes once the bioresorbable screw is degraded. Scaolds for tissue engineering Scaffolds are devices which are used for tissue engineering applications such as bone, cartilage, ligament, skin, and vascular tissues. These products are three dimensional structures, typically porous and hydrophilic, which must be biocompatible and should resorb at the same rate as the repair site remodels. Bioresorbable composites highlighted in the above applications are examples of materials which help to provide tissue engineering products for orthopedic applications. Such polymeric structures help promote the regeneration of bone and cartilage while addressing the mechanical need of the targeted repair site. Polycaprolactone is another polymer which is used to manufacture scaffolding for tissue engineering and is different from lactides and glycolides in its’ high elongation and high permeability. All of these bioresorbable polymers are ideal implant materials in terms of biocompatibility and tailorable degradation parameters. WWW.MEDICALPLASTICSNEWS.COM
Versatility in processing methods Bioresorbable materials may be processed via traditional manufacturing methods including injection molding, extrusion, compression molding and machining. These polymers may also be used in novel manufacturing methods such as electrospinning, selective laser sintering, and fusion deposition modeling. This versatility in fabrication processes provides device manufacturers the opportunity to produce intricate devices using the method which best meets their part requirements. However, to achieve the targeted mechanical performance of the final device, manufacturers should consider the suitability of the implant design in addition to the material properties and fabrication processes. The degradation profile of the final device depends on multiple factors such as polymer crystallinity, molecular weight, part design, sterilisation method, and invivo environment. These considerations are especially important when designing implantable devices with bioresorbable materials. BeneďŹ ts of bioresorbable polymers in medical device applications Bioresorbable materials are used in implant applications because they help facilitate the healing process while temporarily restoring the functionality in targeted areas and eventually absorbing within the body without a trace. Such implantable medical device applications include orthopedic fixation devices, surgical screws, plates, and coronary stents. Unlike other biomaterials, bioresorbables may minimize the need for follow up surgical procedures. Hence, the breadth of commercially available bioresorbable materials along with the possibility to create unique custom polymers offer medical device companies many options in developing devices which deliver life improving therapies.
21
UBM MEDICAL EVENT CALENDAR
UBM medical events are the perfect professional environment to showcase and demonstrate your
innovative technology, equipment, materials, and service solutions. Located in high-performing manufacturing regions, our events enable you to meet new prospects, develop your brand, and engage in thought-leadership conversations.
2017 Calendar BIOMEDevice San Jose December 6–7, 2017
MD&M Minneapolis November 8–9, 2017
San Jose Convention Center San Jose, CA
Minneapolis Convention Center Minneapolis, MN
2018 Calendar MD&M West February 6–8, 2018
BIOMED Boston April 18-19, 2018
Advanced Design & Manufacturing Expo March 7–8, 2018
MD&M East June 12-14, 2018
Boston Convention & Exhibition Center Boston, MA
Anaheim Convention Center Anaheim, CA
Huntington Convention Center of Cleveland Cleveland, OH
Jacob K. Javits Convention Center New York, NY Co-located Model Creates More Opportunity
34693_MN_MDM17
The UBM co-located event model provides a large and diverse crossover audience under one roof, increased visibility for exhibiting companies, and access to more quality prospects in an expanded platform. Approximately 30% of MD&M exhibitor meetings are with attendees registered for colocated event brands.
CONTACT US TO MAKE YOUR EVENT PLANS NOW 866-267-6891
|
medcalendar@ubmamevents.com
CLEANROOMS
Automatically yours
S
epro Group is a manufacturer of robots and automation systems for plastic injection molding. For cleanroom applications, the company uses the same robots Claude Bernard, as for general molding Sepro Group, answers applications, but modifies them in different ways questions about robots to suit the customer’s and automation for need for cleanliness.
cleanroom molding.
Do you develop any equipment for cleanrooms? Sepro does not manufacture any robots specifically for cleanroom applications. Instead, we work with our customers to identify what special design features are necessary to allow them to reach their cleanliness objectives. For instance, we ensure that the robot does not release grease or dust in the molding area. Surfaces are smooth and undecorated so that they can be easily cleaned. Stainless steel is used in many components. All cables are protected in conduits and pneumatic air is filtered to 0.3 micron. When the molding machine is installed inside a 100%-controlled environment, the robot may be installed conventionally, with Cartesian robots mounted above the fixed platen and six-axis articulated-arm robots to the side. In ‘gray’ rooms, where contamination is controlled only in the area immediately around the mold space, both Cartesian robots and 6-axis articulated robots often are installed so they enter the machine from the side. This allows for the top of the molding machine to be free of obstructions that would otherwise prevent the laminar flow of air over the mold space. Sometimes we are asked to supply guarding that prevents particulate or other contamination from entering.
What is different in cleanroom equipment than for standard equipment? Sepro Stäubli 6-axis articulated-am robots have a sealed housing and the standard robots are suitable for ISO 5 cleanrooms without modification. Even Cartesian robots are intrinsically cleaner to operate than the typical molding machine it serves. If the molding machine is clean enough to operate in a given environment, processors can be sure that the robot can also. However, in applications that require the highest levels of environmental control, the machine and the robot may actually be installed outside of the actual clean room. In that case, after removing parts from the mold, the robot might place them on a conveyor or some other transfer mechanism that shuttles them into the clean environment for final processing or assembly. Are you seeing an increase in the use of robotics within cleanrooms? Robots are definitely being used with increasing frequency in cleanrooms, but mostly for the same reasons they are becoming more common across the industry: to improve efficiency and stabilize the process. In medical, as in most other industries, plastic parts are getting progressively more technical in design and application and that increases the need for automation. In medical molding and other controlledenvironment applications, however, there is the added challenge that variability in process conditions cannot be tolerated. And human operators are the most common source of variability and also contamination. By making a human operator unnecessary, a robot eliminates most of the problems that humans can cause. Other factors driving increased
WWW.MEDICALPLASTICSNEWS.COM
use of robots in clean rooms include the fact that a growing number of medical devices, pharmaceutical packaging and drug delivery systems are made of plastics. This means that molders need to be more productive and more flexible and robots help in that regard as well. Can you provide examples of how your equipment is being used in an innovative way? In addition to the precision and repeatability I’ve mentioned before, probably the biggest contribution robots can make to cleanroom molding is in controlled part handling. High-volume production usually requires multicavity tooling and in most commodity applications, parts molded in different cavities can be allowed to mingle on conveyors or in bins or boxes. In medical molding, however, every part must be traceable and data about how it was produced must be stored in case of a problem. That, in turn, means that parts must be removed from the mold and handled individually so that it can be traced back to the cavity in which it was produced. Even the best human operator cannot be trusted to be 100% accurate and consistent hour after hour and day after day. A robot can be trusted. After molding, parts usually undergo some follow-on processing and robots are indispensable here too. A robot can present parts for automated inspection for proper weight, dimensions, optical properties and a host of other variables. It can place the part in fixtures for drilling, welding, assembly or other secondary processes. The robot can stack or pack parts so they are ready for shipment or additional operations… all without operator intervention.
23
M
edical wearables are intrinsic to digital health’s exciting future, but before a new skin-worn device hits the market, it must pass muster for patient Deepak Prakash, biocompatibility, Thijs Janssens, comfort and performance. Vancive Medical Material suppliers and converters can help Technologies, and device makers through the Paul Rosenstein, material selection process.
Pronat Medical, explain why material selection matters when it comes to skin-worn wearables
A digital healthcare revolution has started, and many across the medical ecosystem are engaged in it. This includes providers, patients, insurers, researchers, drug developers, materials suppliers, specialist converters, and, of course, medical device manufacturers. There also are many participants from outside the realm of the traditional medical establishment. These include cloud technology providers, software and app developers, battery and sensor specialists, mobile device makers and many others. Wearable medical devices will play an important role in digital health’s evolution. They enable remote monitoring and anytime-anywhere care delivery, both associated with cost savings, convenience and, in some cases, better patient compliance with treatment plans. This ultimately can lead to more positive outcomes and higher-quality care. Skin-worn wearable devices offer a discreet way to gather vital signs or track physiologic metrics over extended time periods of one to two weeks, or even longer. These ‘smart patches’ also can be used for shorter tests and transdermal drug therapies. As device makers race to bring new products to market, they can benefit from putting an early emphasis on material selection. Alliances with advanced materials suppliers and medical specialist converters can help this process move along smoothly. Ideally, device developers should
24
forge partnerships with medical materials providers and converters well before they lock in specifications and file for regulatory approvals. That way, the partners can work together to evaluate the wearable project’s parameters and collaborate from the beginning on material selection. This approach reduces the likelihood that the device maker will need to switch out one material for another later in the game, which can cause significant delays. First, a few basics Navigating through wearable device material selection may seem like threading your way through a labyrinth of formulations, chemistries, constructions and regulations. To demystify the process a bit, it can be helpful to have a basic understanding of the adhesive materials that serve as wearables’ building blocks. While there are many variables to consider in selecting the right adhesive materials, there are two overarching classifications that provide a helpful framework for the decision-making process. 1. Adhesive purpose. At a high level, there are two primary types of adhesive materials used in skin-worn devices — the kind that hold the device to the patient and the kind that hold elements of the device together. The former are called skincontact layer adhesive materials. The latter are known as construction, or tie-layer, materials. 2. Adhesive fluid handling method: The second big-picture factor to consider is how the adhesive material will manage bodily fluids such as sweat. For wearables requiring extended wear times, moisture management is probably the single most important material performance characteristic. It affects both functionality and patient comfort, which ultimately drive whether the device will be worn as intended and prescribed. There are two primary forms of moisture management:
Moisture-vapor transmission: Tiny holes in the adhesive material allow moisture to move from the skin and out through the material to evaporate. Materials leveraging this approach are referred to as breathable. Fluid absorption: The material absorbs moisture, holding it away from the skin so that it doesn’t cause irritation or clamminess. The material contains ingredients that wick away the majority of the exudate (fluids), forming a gel within the material’s structure. Throughout the wearable material selection process, it’s essential to evaluate the interplay between these core factors. Some skin-contact layer adhesives make excellent bedfellows for some construction-layer materials, and others are incompatible. Their compatibility often is directly related to their moisture management method. For example, if a device maker wishes to use a breathable skincontact adhesive, the manufacturer also should be sure to use a porous construction-layer material or to include air channels in the design. Otherwise, fluids will be trapped and unable to evacuate and evaporate properly. When vapor transmission is the preferred fluid handling approach, acrylic adhesive materials are a popular choice for the skin-contact layer. Acrylic adhesives can be coated onto thin foams or soft non-woven carrier materials. They are very stable, with few residual components that could leech into the skin over extended wear times. For the tie layer, there are breathable transfer (or free film) tapes as well as some new double-coated tapes that provide reliable fixation for device components while complementing the breathability of the skin-contact layer.
S k i n d e e p
ADHESIVES CUTTING EDGE: Complex rotary cutting and laminating in Pronat’s cleanroom
Some wearable device designs simply do not allow for moisture vapor transfer. Perhaps there is an airtight rigid plastic casing required to protect the device’s sensors and battery. Or in other situations, the target patient population may have extremely fragile or damaged skin, prompting the use of a gentle, silicone-based adhesive gel or an absorbent hydrocolloid. In some cases, if a non-breathable device structure has to be used, a specialist converter can perforate certain materials to generate some breathability. When there is no means of ventilation, another solution is to position an absorbent hydrocolloid skin-contact material layer as an island beneath the sensor housing to capture moisture and keep tissue comfortable.
Biocompatibility across the value chain On the material selection journey, device manufacturers need partners who can pave the way to wearables with unquestionable biocompatibility and safety. For example, a medical specialist converter will supply comprehensive documentation regarding how all device materials meet ISO 10993 standards. This is often demonstrated through biocompatibility reports documenting the material supplier’s test results for cytotoxicity, skin irritation and sensitisation according to these standards. Wearable device developers should expect nothing less.
resulting innovations blend diverse expertise, from consumer electronics to pharmaceuticals to social media. The best wearable product development teams leverage this eclectic mix of talent to think outside the box.
Yet safety and optimal device performance ultimately depend on much more than biological evaluation of the material chemistries. The focus on biocompatibility and quality must extend well into the value chain. Suppliers’ facilities should be ISO 13485 certified, which means their operation’s quality management systems meet strict standards for the design and manufacture of medical devices. Top medical materials providers and specialist converters also will have extensive clean room and sterilisation capabilities. Only when all of these pieces come together, complete with end-to-end best practices and process controls, can the wearable device maker rest assured that the final product will be free from contamination and contain only safe components.
But for skin-worn wearables, it’s also important to be sure an industrial designer has a medical device mindset, including strong anatomical knowledge. When such an industrial designer is guiding development, and working closely with an experienced medical material supplier and specialist converter, a wearable device project can avoid some pitfalls and setbacks. As just a few examples, the industrial designer will anticipate and address concerns such as: How smart patch body placement relates to sensors’ ability to pick up the clearest signals; Why different adhesive materials are needed to fixate devices to body areas with highly flexible skin vs. flat, tight skin; How sweat levels and bodily secretions vary by body part; Why medication regimens for certain chronic diseases can cause skin to be very fragile; How device removal must be atraumatic, especially for pediatric patients. It is also important to note that up to 10% of the general population is likely to react badly to skin-worn adhesives, especially acrylic adhesives. This is a reality that needs to be borne in mind during clinical trials and wear tests.
Industrial design and a medical device mindset The digital health market, and wearables as a high-growth category within it, have both benefited from multidisciplinary participation in an exciting wave of product development and commercialization. Never before has the healthcare industry witnessed this level of involvement from entrepreneurs, scientists, venture capitalists and technologists from all walks of life. The
In conclusion, skin-worn wearable devices will continue to support the rollout of revolutionary digital health initiatives. With patient care on the line, they must be comfortable, safe, easy to use and reliable. It’s important to devote attention to materials selection very early in the device development process. With collaborative partners from advanced materials and medical converting, wearable device makers can stay ahead of the curve in performance, biocompatibility and patient experience.
25
Plastiward - Re-thinking in-plastic protection for plastic medical devices and pharmaceutical packaging
WEBINAR
Date: Thursday 7th December 2017 Time: 13:30 GMT, 14:30 CET, 08:30 EST, 18:00 IST Price: Free
Practical implementation steps to help stop fake drugs and devices getting into patients’ hands Patient safety is the top priority for all players in the pharmaceutical and medical devices industry. As part of their mission, many companies in the sector commit to providing access to safe medicines. The WHO estimates that up to 8% of medical devices and up to 30% of medicines on the market are fakes. During our first webinar, experts agreed it is a growing problem, and serialisation on its own is not the solution.
Speakers: Mr Steve Duckworth, Head of Global Segment Medical & Pharma, BU Masterbatches, at Clariant Plastics & Coatings Ltd, is responsible for medical & pharma products
Mr Yann Ischi, Director New Channels & Partnerships at SICPA, is responsible for security solutions for private-sector clients, including pharmaceuticals
• What happens when a medicine/device is a fake – even though it carries your brand name? • How can you stop fake drugs from getting into your patients’ hands? • How can you make field inspections efficient, so that you can take fast countermeasures? • How can you take advantage of your drug being delivered in a plastic medical device? Join SICPA, Clariant and Kroll for the second of a two-part webinar series. In this webinar, focusing on Plastiward, you will learn:
Special guest from Kroll’s Business and Cyber Investigations team, specialising in digital investigations, including open source, and the tools and methodologies that enable clients to combat cybercrime, leaks of confidential information, counterfeiting, and intellectual property (IP) theft
Register Now
www.medicalplasticsnews.com/webinars Can’t make the date? Sign up any way and we will send you an on demand copy after the event.
• Why fast authentication in the field offered by Plastiward, is a key element in your brand security measures and protecting the patient. • What advantages the Plastiward real-time monitoring platform offers during an investigation process. • How Plastiward can be included in the protection of your medical device/packaging: close to the drug and low impact on design, regulatory, production.
Medical Plastics News is the voice of the medical plastics industry. It is an essential source of business critical, highly relevant and unique intelligence, which stimulates thought leadership and nurtures an innovative and connected community of industry stakeholders.
SICPA is a trusted global provider of security inks as well as secured identification, traceability and authentication solutions. With high-technology security inks at the core of its expertise, the company protects the majority of the world’s banknotes, security and value documents, and a wide range of consumer and industrial products. It offers solutions and services to governments and industry, ensuring product authentication, traceability and protection as well as tax reconciliation.
As one of the world’s leading specialty chemical companies, Clariant contributes to value creation with innovative and sustainable solutions for customers from many industries. Our portfolio is designed to meet very specific needs with as much precision as possible. At the same time, our research and development is focused on addressing the key trends of our time.
CATHETERS
Heart disease is responsible for 173 million deaths globally
Take heart A
ccording to the American Heart Association, heart disease is responsible for 173 million deaths globally a At UC Davis, work year and is the number is underway on a one cause of death. new cardiac catheter In a bid to combat the that combines light disease and reduce and ultrasound numbers, researchers at UC Davis have been to measure working on a medical plaques. Holly device that identifies the Ober, Department composition of plaque of Biomedical that is most likely to Engineering, UC rupture and cause a heart attack.
Davis, explains
Angiography allows the examination of blood vessels for constricted regions by injecting them with a contrast agent before X-raying them. However, because plaque does not always result in constricted vessels, angiography can miss dangerous build-ups of plaque. Intravascular ultrasound can penetrate the buildThis new catheter probe combines intravascular ultrasound (IVUS) with fluorescence lifetime imaging (FLIm) to image the tiny arteries of a living heart
up to identify depth, but lacks the ability to identify some of the finer details about risk of plaque rupture. Professor Laura Marcu’s lab in the Department of Biomedical Engineering at UC Davis has now combined intravascular ultrasound with fluorescence lifetime imaging (FLIm) in a single catheter probe that can image the tiny arteries of a living heart. The new catheter can simultaneously retrieve structural and biochemical information about arterial plaque that could more reliably predict heart attacks. The new device is described in a recent paper published in Scientific Reports. An optical fiber in the catheter sends short laser pulses into surrounding tissue, which fluoresces with tiny flashes of light in return. Different kinds of tissue (collagen, proteins, lipids) emit different amounts of fluorescence.
WWW.MEDICALPLASTICSNEWS.COM
At the same time, an ultrasound probe in the catheter records structural information about the blood vessel. Seeking FDA approval for human trials The combination FLIm-IVUS imaging catheter provides a comprehensive insight into how atherosclerotic plaque forms, aiding diagnosis and providing a way to measure how plaques shrink in response to therapy. The new catheter has been tested in living swine hearts and samples of human coronary arteries. The catheter used in the study is flexible enough to access coronary arteries in a living human following standard procedures. It does not require any injected fluorescent tracers or any special modification of the catheterization procedures The new technique could not only can improve understanding of mechanisms behind plaque rupture - an event with fatal consequencesbut also the diagnosis and treatment of patients with heart disease.
27
Drew Rogers, Trelleborg Sealing Solutions, looks at extrusion and molding, and the advantages and disadvantages of processing methods for medical silicone polymers
W
ith biofluid compatibility, favorable haptic as well as physical, chemical and processing attributes, silicone’s popularity for use in medical devices continues to grow. Advancements in medical polymer architecture further facilitate many novel nextgeneration medical devices and implants. Bringing together the ideal combination of material, component design and manufacturing process within the right framework of regulatory compliance is the key to fulfilling a device’s intended fit, form and functions reliably. Expertise from a silicone and polymer processing specialist, and due diligence at the early stage of concept and development, pay tribute later for timely and smooth market launch and industrialization. We’ll review the advantages and disadvantages of several types of processing for silicone and medical polymers. 1. Injection Molding Injection molding allows highly efficient high volume manufacturing of components in – depending on sophistication of tooling – very complex and intricate geometries. Cavitation per mold is tailored from one to several hundred depending on complexity of part and capacity needs. A part and application may lend itself to be produced from liquid silicone rubber (LSR) in a liquid injection molding (LIM) process. LSR has the potential to be used in combination with an engineered plastic using a 2-shot (or more) fully automated injection molding set-up. In line with the complexity of the finished product, developing a tool-grade steel mold, hot- or cold-runner blocks, and process automation equipment can be expensive upfront. However, at high volume and over the life of a program, the tooling costs per part can actually be quite low. Injection molding, and even
28
more so LIM, can produce high integrity parts over very high volumes. The molding efficiency depends on decisions and choices made around mold and process design as to details such as cavitation, basic tool construction, gating, venting, surface finish, and supporting automation. It will also need to integrate seamlessly with equipment that pumps, mixes, injects, compresses, heats and ejects. Creating a mold for a seal to be used in a medical device typically requires early, close collaboration between engineering teams at the device maker and the seal supplier. This will ensure the correct material selection and adherence to regulations, while minimizing variability, maximizing yield, and reducing costs by optimizing seal geometry, tooling and process engineering. Advantages of Injection Molding l Liquid Injection Molding l Facilitates complex designs; ideal for parts with a large amount of detail such as undercuts or thin wall sections Ideal for micro- and nano l sized parts l Accommodates hard-soft combinations via a 2-shot LSR process l Highest efficiency of any molding method with short cycle times and possibility of full automation l Ideal for very high volumes in flashless quality l Injection Molding l Enhanced strength; fillers can be used to reduce the density of the silicone while it’s being molded, further strengthening the molded part l Multiple silicone types can be utilized and tailored to the application conditions and molding process requirements l Metal or plastic elements can be integrated into the part l Efficient process for technical parts in medium to high volumes in semi-automation
Disadvantages of Injection Molding l Liquid Injection Molding l Highest initial tooling cost that must be considered as an investment over the life of a tool; which is, however, the longest of any type of injection molding tool, i.e. typically one million shots l Injection Molding l Design restrictions, including the fact that all parts must be solid and must have drafting if they are perpendicular to the tool opening l There may be restrictions on part thickness to avoid shrinkage problems l Requires part de-flashing operation with additional cost 2. Compression molding The compression molding process is ideal for parts beyond the size capacity of extrusion or injection molding and for moderately complex parts in low quantities. The process is used in medical applications such as diaphragms for respiratory equipment, lip seals for cylinder applications, and isolation bumpers used to inhibit vibrations. Compression molding is also used to manufacture thermoset plastic parts. The raw materials for compression molding are either granules, putty-like masses, or preforms. The raw material is placed in an open, heated mold cavity to which pressure is applied, forcing the material to fill the cavity. Advantages of compression molding: l Cost-effective for smaller volumes; low tool costs l Parts can be made to customer specification from specified materials l Flexible mold design ·
WWW.MEDICALPLASTICSNEWS.COM
WEIGHIN The pros and cons of processing methods for medical polymers
EXTRUSION REPLACEMENT MARKET: Thanks to advances in thermoplastic polymers, plastic tubing is replacing metal tubing in many medical devices
l Tools with multiple cavities can be created l Quick turnaround of tools and parts l Good surface finish Disadvantages of compression molding: Slower part production
l rates l Involves largely manual process steps l Requires post-molding operations to remove flash l Precision is good but limited to a normal level for rubber parts l Largely used for simple to moderately complex shapes with no undercuts
ING IN:
A further option for production of moderate quantities of complex rubber part geometries is transfer molding. Here, the elastomer is first heated in a pod to then be injected into the hot cavity. 3. Extrusion Silicone is a completely inert, biocompatible and versatile material in medical extrusion. In medical devices, both peroxide and increasingly platinum-cured silicone grades enjoy increasing popularity, the latter due to its increased purity and faster production cycle. Thanks to advances in thermoplastic polymers, such as polyether ether ketone (PEEK), polyurethanes, and polyolefins, plastic tubing is replacing metal tubing in many medical devices. PEEK is an alternative to stainless steel as it is strong and has a low friction coefficient. PEEK and polyphenylsulfone (PPSU) are used for long-term implantable components because of their biocompatibility.
Advantages of extrusion l Accommodates high production volumes l Provides efficient melting l With plastics, allows for post-extrusion manipulations l Offers considerable flexibility in manufacturing products with a consistent cross-section Disadvantages of extrusion l Difficult to predict the exact degree of expansion l Subject to size variances l Some product limitations 4. Multiple-Profile Extrusion (MPE) MPE eliminates secondary bonding operations through its ability to mate with a variety of tube profiles. The process produces a single, continuous tube, eliminating the need for leak testing. It also provides ‘on the fly’ manipulations, allowing the cross-sectional profile of a silicone tube to change during extrusion, reducing costs. The absence of a seam also greatly enhances product performance, mitigating areas where bacteria can accumulate. With MPE, there is no need for secondary bonding, thereby reducing costs and increasing production speed. Double extruder configurations allow for a range of stiffness and flexibility in tubes. The amount of flexibility can be controlled by thinning out the extrusion wall or switching to a softer or stiffer material along the extruded profile. Within the MPE process, two or more lumens can easily be split off a center lumen or merge two lumens into a single lumen – all in a single continuous extruded tube. The multi-lumen process involves moving dies and mandrels in sync, reducing cross contamination of fluids in the separate lumens.
WWW.MEDICALPLASTICSNEWS.COM
Advantages of multiple profile extrusion l Facilitates the extrusion of balloons of any length l Removes secondary bonding operations l Allows for seams to be eliminated l Various types of tubing (single lumen, multi-lumen, transitional GeoTrans, etc.) can be produced, as well as rod, ribbon, and other non-standard profiles l Suitable for extruding both elastomers and foams Disadvantages of multiple profile extrusion l Material choices limited to HCRs (high consistency rubber) l Issues can arise from having to move dies and mandrels in sync l Cross contamination of fluids in the separate lumens can occur Conclusion The ability of silicones and thermoplastic polymers to be formulated and processed to attain specific performance, aesthetic, or therapeutic outcomes makes them suited for many medical devices. Device designers and makers – either at OEM or CMO basis – need to have a basic understanding of the diversity of processing options available, or bring on board from the early concept stage of a new device a processing expert for silicone and other polymer components. With time-to-market being such a critical element in the creation and sale of medical devices, the ability to produce rapid prototypes, quickly reach a final design, and consistently produce and deliver high-quality products, are the keys to success.
29
The layer effect: Raumedic develops solutions by multilayer extrusion, making medical products from infusion tubing to filling tubing, safer and more efficient
Round trip Gert Walter, Business Unit Tubing, Raumedic, discusses coextrusion technology and its potential for opening up areas of medical applications
C
oextrusion and multilayer extrusion make it possible to use several different materials in one single tubing, providing a modern, effective and in practice, optimized solution that can be used in a range of medical applications. Polymer specialist Raumedic develops solutions by multilayer extrusion, making medical products from infusion tubing to filling tubing, safer and more efficient. The role of coextrusion in medical engineering The use of multicomponent technology under cleanroom conditions provides an excellent foundation for the
30
development of new medical and pharmaceutical products. As well as improved cost, the objective is to achieve improved functionality in new tubing products with the help of coextrusion technology. And while multilayer extrusion for the production of films in applications like food packaging no longer represents a significant challenge for modern tool and machine technology, coextrusion of multiple polymer layers in the production of microdimensional tubing for medical engineering is still uncharted territory in many cases. Nowadays, microextruders are able to produce multilayer tubing from up to four different polymer materials. The smallest achievable inner tubing diameter is about 100 µm, with a minimal wall thickness of approximately 50 µm. Microextruders can work at minimal material throughput rates, with an output of less than 30 grams per hour. The advantages of coextrusion processes for medical engineering are obvious: l Application-specific distribution of layer thicknesses l Embedding of several color stripes and x-ray contrast stripes l Integration of functional layers eg for light protection
properties or gas barrier l Use of bonding agents for incompatible polymers against delamination Suitable materials for multilayer tubing In theory, any polymer can be used in coextrusion. In practice, however, those thermoplastics are used that have already proven their worth in other processing techniques in medical engineering and pharmaceuticals: polyurethanes, polyamides, polyolefins, thermoplastic elastomers, and to some extent soft PVC as well. Multilayer tubing for medical applications To protect light-sensitive solutions and ensure loss-free dosage of sensitive drugs, Raumedic has developed the products Rausorb, Rauinert and Rausonert. These three examples of medical engineering reflect the growing importance of multilayer extrusion. Drug-compatible infusion tubing for highly sensitive drugs For decades, soft PVC has proven its worth as an efficient and easy-to-process material for flexible infusion lines. Even today, well over 90% of all infusion tubing is made from
WWW.MEDICALPLASTICSNEWS.COM
soft PVC. With advances in the development of highly effective new drugs however, especially in oncology, an increasing number of problems have arisen involving drug compatibility with the PVC tubing material. Many highly-sensitive drugs are adsorbed on the tubing’s surface, with the result that only a fraction of the intended dose actually reaches the patient.
IN THE BAG: Connector tubes for infusion and dialysis bags
TUBING Conversely, ‘undesirable side effects’ may occur, if plasticizers and other additives are released from the PVC material by the infusion solution. This happens most often when the infusion solution contains fatty substances or lipid-like solubilizers. Optimized application of soft PVC in multilayer tubing In order to continue using soft PVC as a safe material in the production of multilayer tubing despite these challenges, Raumedic has developed Rauinert. The layering most commonly used with this product consists of an LDPE inner layer, an EVA bonding agent and a PVC outer layer. Polyethylene is chemically neutral in contact with the flow-through medium. The EVA middle layer serves as a bonding agent between the LDPE and PVC layers, since those two materials would not otherwise form a strong bond to one another in the coextrusion process. The outer layer made of soft PVC ensures that the manufacturer of the final infusion tubing sets is able to conduct all of its processes just as he would with any ordinary PVC tubing. This includes bonding, packaging and sterilization, for example. The market share of this type of highly-specialized multilayer tubing in infusion therapy is expected to grow in years to come. At the same time, new ideas are also being implemented. Compared with other production methods, multicomponent extrusion technology offers immense freedom in form and design, through its combination of multiple polymeric materials with the integration of additional functions. Protecting light-sensitive pharmaceuticals is increasingly important Pharmaceuticals that are activated by exposure to light, or that break down in a photochemical reaction are increasingly used for special therapies. Substances like vitamin A and sodium nitroprusside take their
SENSITIVE TYPE: Raumedic Rausorb is for light-sensitive solutions
MAKING GAINS: Raumedic Rauinert allows for loss-free dosage of sensitive drugs
IDEAL SOLUTION: Raumedic Rausonert facilitates loss-free dosing of light-sensitive solutions
activation energy from visible and invisible light in different ranges of wavelengths. To provide the required protection for these substances, the development of black tubing seemed to solve the problem. This, however, makes it impossible to monitor the infusion solution. As a result, any gas bubbles, impurities or other problems cannot be detected when they occur. Other solutions available on the market involve transparently colored tubing, or windowed tubing made of a clear material including semi-circular segments of light-proof coextrusion materials embedded in the tubing wall. But these solutions are merely a compromise at best, since they do not comply with the applicable pharmacopoeias and relevant standards. A solution for light-sensitive drugs Multilayer tubing from the Rausorb line meets medical engineering requirements. The inner layer of this special tubing is physiologically harmless. The outer sheath is infused with light-absorbing substances that correspond to the spectrogram of each individual infusion solution.
With this technology, any chosen combination of wavelengths in the 220–800 nm range can be largely filtered out. Since each preparation is only sensitive to a very specific set of wavelengths, there are enough ranges remaining to allow for the production of transparent tubing that still blocks all but a negligible amount of light in the critical wavelength ranges. This makes it possible to develop tubing that is specific to individual drugs. Loss-free dosing of lightsensitive solutions For drugs that are both lightsensitive and PVC-incompatible, the Rausonert tubing line offers custom-tailored solutions – with regard to the requirements of later processing steps as well. Inert inner tubing layers are coextruded with light-absorbing outer layers. The possible combinations of materials and dimensions are virtually unlimited. Filling tubing for PVC-free infusion bags The trend towards the use of lightweight, flexible and unbreakable polymeric materials is developing in containers for infusion solutions.
WWW.MEDICALPLASTICSNEWS.COM
For infusion bags, the first step was the use of PVC films, tubing and connectors containing plasticizers. Since the early 1990s, there has been an intensive search for alternative materials free of plasticizers and chlorine. For films, the industry quickly achieved adequate levels of quality that had already proven their value in the food industry. The films in question were multilayer films made from polypropylene or polyethylene/ bonding agent/polyester that comply with the requirements for transparency and ability to be sterilized with water vapor at 250°F (121°C). These PVC-free film bags require special filling tubing that is now produced in coextrusion technology. In developing these types of tubing, the goal was to provide an outer layer with good thermal weldability with all common films. At the same time, the inner layer should also provide excellent bonding to all common connector materials, such as polycarbonate, polypropylene or hard PVC, during the steam sterilization process. Naturally, this combination of properties cannot be achieved in a single polymer formulation. Construction of filling tubes for infusion bags This special two-layer tubing is composed of an inner layer of ethylene-vinyl-acetate-copolymer (EVA) and an outer layer made of thermoplastic elastomer (TPE). The EVA provides excellent bonding to polycarbonate connectors, but must be crosslinked in order to maintain its shape at 250°F (121°C). If polypropylene connectors are preferred, three-layer tubing with a soft PP/soft PP/TPE layering can be used. With this layering, the modified polypropylene in the inner layer provides good bonding to PP injection ports, while the flexibility or stiffness of the tube as a whole can be variably controlled through the formulation of the soft PP middle layer.
31
5
FIVE REASONS to pick up an MD&M Minneapolis conference pass 1. Unlimited Track Hopping: Choose any session across all three tracks to build the agenda that’s right for you. 2. Leading Education: Get up to speed on industry mainstays including IoT, bioprinting, 3D printing, VR, AI, surgical robots, and so much more. 3. Top Speakers: Learn from the brightest minds at top companies including Medtronic, Boston Scientific & Texas Instruments. 4. Exclusive Networking: Make connections with serious professionals at networking lunches and a cocktail reception for conference pass holders only. 5. Curated Tours: Open only to conference, join a tour of the show floor to meet top suppliers and dive deeper into cutting-edge topics.
32
Medtech in Minneapolis
B
illed as the region’s largest medtech event, MD&M Minneapolis is back for the 23rd year. This year’s event will unite 5,500 professionals and more than 600 suppliers on November 8–9 at the Minneapolis Convention Center. Its organisers have announced an expanded conference program, more expert-led sessions on the
expo floor, networking activities, and group tours — plus an exclusive keynote by Eric Topol, pioneering cardiologist, digital medicine researcher, and bestselling author. The event is home to the largest showcase of industry suppliers in the region — as well as a range of free presentations, interactive events, and fun
activities. Whether your focus is new materials, intelligent sensors, testing solutions, components, packaging, or anything else in the medtech arena, source cuttingedge products and services in a time-saving format with more than 600 solution providers across the full spectrum of medtech manufacturing.
Doctor in the house:
Digital health pioneer gives keynote speech At noon on 8 November, Eric Topol, cardiologist, digital health pioneer and best-selling author will give his talk Healthcare ex machina: How artificial intelligence will transform medicine. Topol will explain how machine learning applications can now diagnose some conditions as well as or better than doctors and at a fraction of the cost. But harnessing deep learning to improve medicine will require significant changes across the healthcare industry. Topol is a professor of genomics at The Scripps Research Institute, and the founder and director of The Scripps Translational Science Institute (STSI). As a researcher, he has published over 1,100 peerreviewed articles (with more than 170,000 citations), was elected to the National Academy of Medicine,
and is one of the top 10 most-cited researchers in medicine. His principal scientific focus has been on the genomic and digital tools to individualize medicine — and the power that brings to individuals to drive the future of medicine.
WWW.MEDICALPLASTICSNEWS.COM
In 2016, he was awarded a $207 million grant from the National Institutes of Health (NIH) to lead a significant part of the Precision Medicine Initiative, a prospective research program called All of Us, which gathered data from more than one million Americans to accelerate research and improve health.
5 THINGS TO CONSIDER
WHEN MANUFACTURING CONNECTED DRUG DELIVERY DEVICES The estimated number of connected drug delivery devices continues to increase and the impact of this trend could be significant, explains Phillips-Medisize.
While digital connectivity, or connected health, can improve the coordination and delivery of patient care, original equipment managers need to keep these five things in mind when creating connected drug delivery devices: 1 2 3 4 5
Development strategy and design consideration Situation analysis and patient compliance Connectivity ecosystem Wireless subsystem Security of device and information
As the Internet of Things continues to become an integral part of people’s lives, the opportunity to use it within drug delivery device applications remains promising. The manufacturers and device designers must identify, investigate and overcome these challenges so that the implementation of wireless and other related smart technologies can be achieved. When done successfully, connected systems enable the patient and caregivers a 360° view of both the patient and the disease – not only to manage adherence, but to improve results by understanding the effect of the regimen.
www.phillipsmedisize.com