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MEDICAL PLASTICS news
CURRIER PLASTICS EXPLAINS THE IMPORTANCE OF CUSTOM MOLDING
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THE LATEST IN ADHESIVE TECHNOLOGY STERILIZATION IN THE SPOTLIGHT EXTRUSION EXPERTISE
ISSUE 8
Oct/Nov/Dec 2018
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ADVANCING MEDICAL PLASTICS
CONTENTS MPN North America | Issue 8 | Oct/Nov/Dec 2018
Regulars
Features
3 Comment Lu Rahman asks why the medical device sector hasn’t been awarded celebrity status
18 From buildings to medical device: How architects created a healthtech breakthrough
32 An expert view Microspec Corporation talks to MPN about the benefits and challenges of extrusion
20 Clearing the way MTD Micromolding explains how to overcome roadblocks in micro medical
34 Why innovation matters DowDuPont, and Eastman Chemical Company, explain how new technology broadens medical device materials
5 News focus 6 Digital spy 13 Opinion Aaron Johnson, Accumold offers industry insight 16 Cover story Currier Plastics outlines the importance of custom molding in the IVD industry 36 Back to the Future
23 Resourceful thinking Sterilization expertise from Nelson Labs and Velox 29 Made to measure: When off the shelf won’t do Vancive Medical Technologies, discusses how collaboration on material selection can lead to bespoke adhesives
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CREDITS head of content | lu rahman deputy group editor | dave gray
EDITOR’S
comment
reporter | reece armstrong advertising | gaurav avasthi head of media sales plastics & life sciences | lisa montgomery head of studio & production | 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: North America: FREE UK and Europe: $249 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 © 2018 Rapid Life Sciences Ltd While every attempt has been made to ensure that the information contained within this publication is accurate the publisher accepts no liability for information published in error, or for views expressed. All rights for Medical Plastics News are reserved. Reproduction in whole or in part without prior written permission from the publisher is strictly prohibited.
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When will the medical device sector get its celebrity endorsement? We quite often hear that the medical device sector isn’t about revolution but evolution. But does it really matter? And does that detract from some of the innovative and groundbreaking products on the market? Let’s face it, which manufacturing sectors can say, hand on heart, that they deliver significant innovation on a regular basis? Let’s not forget that in addition to these incremental changes, behind the scenes there are huge steps taking place in the materials and components markets that play a key role in the advancement and success of medical devices being developed and launched each year. Antimicrobial products help keep harmful and potential fatal germs out of our way; digital devices are being designed that offer incredible functionality and can mean less hospital visits for some, while, industries such as micro manufacture and sensors are helping advance products to an unprecedented level. As I’m writing this, Gwyneth Paltrow is being interviewed on the TV, explaining the ethos behind her Goop brand. Of course, she’s entitled to her view that some of the products on her website, while in no way, shape or form, could be described as conventional, do have a place in the improvement of the health and wellbeing of many people (mainly women). Despite a Santa Clara County DA declaring that one of Paltrow’s products wasn’t “supported by competent and reliable science”, the actress still attracts significant media
coverage for her efforts – the launch of her Goop store in the UK has been well publicised, for example. Her celebrity status means she’s perfect fodder for the newspapers – and who wouldn’t want a slice of an A-list celebrity lifestyle? For me, it’s just a shame that despite Paltrow’s claims, these ‘alternative’ products can sometimes overshadow some of the major efforts being made to improve lives and assist the millions of people living with medical conditions and diseases. Medical device manufacturers or suppliers often admit that this sector isn’t full of trailblazing innovation. Changes come slowly and incrementally but it’s these small efforts that often end up making a significant difference. It’s clear that we don’t need to redesign the wheel, but any changes that make it go faster, more efficiently and lead to cost savings, will be swooped upon, and rightly so. Ultimately, we as patients, benefit. This aspect of our sector is exciting. The development of digital technology has helped create medical devices that treat illness by improving the experience for both the patient and the clinician. We have to applaud this type of development. It’s this type of device evolution that should be awarded celebrity status – when suppliers and manufacturers look to science and FDA regulations for the development of materials, components and devices, we should put them in the headlines instead of sometimes unproven products with celebrity backing?
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When suppliers and manufacturers look to science and FDA regulations for the development of materials, components and devices, we should put them in the headlines instead of sometimes unproven products with celebrity backing?
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NEWS FOCUS
How US life science CEOs view digital transformation and AI compared with global peers US CEOs more likely to say they are achieving return on investment than global peers, says KPMG report
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EOs of large life sciences companies anticipate quickly recouping investments in digital transformation and artificial intelligence (AI), while those in the US are expecting or have achieved quicker returns than their global peers, KPMG’s 2018 CEO Outlook found.
achieved a significant return on investment in artificial intelligence and digital transformation programs.
KPMG surveyed CEOs at companies with more than $500 million in annual revenue about their anticipated return on investment from artificial intelligence. This is a result of looking at 109 CEOs in the life sciences sector, which includes 40 based in the United States.
AI AND LIFE SCIENCES JOBS Artificial intelligence and automation have traditionally been seen as threats to employment. However, 60% of US life sciences CEOs – 67% globally – see AI creating more jobs than it eliminates. The anticipated benefits from AI tend to vary by market, where the US based executives see cost savings and risk management as the biggest factor. CEOs outside the US see the technology helping their data governance and customer service.
“Life sciences CEOs – and particularly those in the US – are much more optimistic about their digital transformation efforts than some of the other industries, because the ability to capture data more effectively is making medicine more personalized, effective and efficient,” said Liam Walsh, KPMG LLP line of business leader for healthcare & life sciences. Most life sciences companies have made investments in AI in some form, according to the CEO Outlook. US life sciences CEOs were also more likely to see the strategic value of these investments – as opposed to the tactical value – than their global counterparts. Among the US CEOs surveyed this year, 25% said they have already achieved significant returns from AI investments and also digital transformation programs that have reshaped business functions such as product development, finance, IT, human resources, regulatory compliance, and marketing. Only 9% of global life sciences CEOs said they’ve already
Another 33% of CEOs surveyed – both globally and in the United States – expect their investments in digital transformation to pay off within 12 months, the survey found.
“AI and other emerging technologies will transform how life sciences organizations operate in the future, since patients can be matched to more effective treatments and business processes can be made more efficient,” said Katie Dahler, KPMG LLP advisory leader for life sciences. “The need for this technology in life sciences becomes more apparent in the ‘beyond the pill’ services that pharma companies are establishing to treat more complex medical conditions.” KPMG surveyed nearly 1,300 CEOs at companies with more than $500 million in annual revenue, including 400 based in the United States for the 2018 CEO Outlook. For life sciences portion of the survey, 109 were surveyed around the world, including 40 in the United States.
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DIGITAL
spy
MATERIAL UPDATE
TECHNOLOGY UPDATE
www.fostercomp.com
www.wyss.harvard.edu
i can see clearly now:
walk the walk
Translucent compounds available
SMART ROBOTIC SUITS DEVELOPED
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n the future, smart soft robotic exosuits could be worn by soldiers, fire fighters and rescue workers to help them cross difficult terrain and help them perform their respective tasks more effectively. They could also become a means to enhance mobility and quality of living for people suffering from neurodegenerative disorders and for the elderly. Conor Walsh’s team at the Wyss Institute for Biologically Inspired Engineering at Harvard University and the Harvard John A Paulson School of Engineering and Applied Sciences (SEAS) has been at the forefront of developing different soft wearable robotic devices that support mobility by applying mechanical forces to critical joints of the body, including at the ankle or hip joints, or in the case of a multi-joint soft exosuit both. While the researchers have demonstrated that lab-based versions of soft exosuits can provide clear benefits to wearers, allowing them to spend less energy while walking and running, there remains a need for fully wearable exosuits that are suitable for use in the real world. The multi-joint soft exosuit consists of textile apparel components worn at the waist, thighs, and calves. Through an optimized mobile actuation system worn near the waist mechanical forces are transmitted via cables
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oster Corporation, polymer solutions expert for medical devices, has launched ProPell T which is designed to offer lower lubricity and translucency in medical device components when added to lower durometer TPU and Pebax polyamide elastomer compounds.
that are guided through the exosuit’s soft components to ankle and hip joints. This way, the exosuit adds power to the ankles and hips to assist with leg movements during the walking cycle.
Similar to the existing ProPell product line, Foster says ProPell T offers reduced coefficient of friction (CoF) while maintaining critical mechanical properties, and improved manufacturing and handling of medical catheter tubing. ProPell T also offers a proprietary surface enhancing additive that, according to Foster, provides translucency unlike anything on the market today.
“We have updated all components in this new version of the multi-joint soft exosuit: the apparel is more user-friendly, easy to put on and accommodating to different body shapes; the actuation is more robust, lighter, quieter and smaller; and the control system allows us to apply forces to hips and ankles more robustly and consistently,” said David Perry, an engineer on Walsh’s team.
“Medical personnel can not only see the substance that is being transported through the tubing, but can also easily detect any defects in the device,” explained Larry Johnson, vice president of business development for Foster Corporation. The ProPell T technology reduces tackiness and friction in medical device components, especially soft, flexible polymers such as low durometer TPU, commonly used in central venous catheters (CVC), and Pebax polyamide polymers that are used in interventional vascular catheters. “The use of ProPell T in catheters benefits medical practitioners by offering easier deployment and control of the device by enabling the catheter to move faster and smoother through the vascular system,” Johnson added.
DIGITAL UPDATE
www.polyone.com
Medical plastics expert plays key role IN NEW OXYGEN DEVICE
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olyOne has collaborated with Rapid Oxygen, a Stamford, CT-based company, on polymer selection for the development of its new emergency oxygen device called R15. Launched this month, the FDAcleared unit is marketed as the only emergency oxygen device that is non-explosive, portable, easy to use, and doesn’t require external power. PolyOne provided a variety of solutions from its distribution portfolio to address the needs for internal and external R15 components. A number of material types and grades
from PolyOne, Covestro, and Trinseo were used to meet critical short- and long-term device needs that included impact, chemical, and high temperature resistance, as well as dimensional and color stability. The patented, portable, R15 emergency oxygen delivery system can be deployed everywhere an AED (automated external defibrillator) is located to help a person with airway or cardiac emergencies in the first critical minutes before EMS arrives. It can be placed in virtually any public location, much like a fire extinguisher.
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Working in conjunction with the University of Michigan and a team of scientists and engineers, Rapid Oxygen CEO and founder, Richard Imbruce, developed the R15 to deliver 15 minutes of 100% humidified oxygen at 6 liters per minute. “We were inspired by the need to make oxygen accessible to more people in emergency situations,” said Imbruce.
DIGITAL SPY
MATERIAL UPDATE
www.gncanada.com
on target
Canadian supplier praises NPE after spate of orders for thermoforming equipment GN Thermoforming Equipment, manufacturer of servo-driven, rollfed thermoforming machines for the production of plastic packaging and medical applications, has received multiple orders from US and Canadian processors for its new GN800 thermoformer. The company has enjoyed strong sales for its new thermoformer following a highly successful NPE in May which attracted many high-value attendees who were in the buying mood, according to Jerome Romkey, GN’s vice president of sales and foreign operations.
talking
POINT
“Overall, traffic was down at the booth but we were pleased to see that the quality of attendees was superior to previous shows,” said Romkey. “It was a great show because we had a targeted group of visitors – they were at NPE for a reason and interested in buying.” GN received orders for six units and expects further increased business activity over the next several months in the US, Mexico, and the Caribbean, said Romkey.
Moving story IMPLANT HELPS PARALYSED PEOPLE WALK AGAIN Is it true that an electrical implant has helped paralysed people to walk again? Yes, a small group of patients has had a device implanted that electrically stimulates the spinal cord. According to the BBC in the UK, the device, “which is placed below the injury, helps lost signals from the brain reach leg muscles”.
DEVICE UPDATE
Fast workers: NEW DEVICE LAUNCHES FROM FREUDENBERG MEDICAL AIM TO ACCELERATE TIME TO MARKET www.freudenbergmedical.com
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reudenberg Medical has announced several new options for medical device companies looking to accelerate time to market. The Composer XL Deflectable Catheter Handle Platform offers a commercialization-ready interface to provide integrated control and has been sized for large bore structural heart and endovascular devices such as transcatheter tricuspid and mitral valve delivery systems. Meanwhile, the HyperSeal XL, is a new member to the hemostasis valve family, designed to provide a robust design option for vascular access applications up to 30Fr and 40Fr. Also making their debut this year’s are the 8.5F and 12Fr
Composer Steerable Introducers, new finished device solutions for private label development and customization for a range of electrophysiology, structural heart and vascular applications.
Where has the technology been developed? The breakthrough has come out of work carried out by the University of Louisville and the Mayo Clinic. One of the participants, Kelly Thomas, 23, has experienced positive results from the treatment, as well as extensive rehabilitation therapy. She said: “Being a participant in this study well and truly changed my life, as it has provided me with a hope that I didn’t think was possible after my car accident. “The first day I took steps on my own was an emotional milestone in my recovery that I’ll never forget, as one minute I was walking with the trainers’ assistance and while they stopped, I continued walking on my own. It’s amazing what the human body can accomplish with the help from research and technology.” How exactly does it work? This research is based on two distinct treatments: Epidural stimulation of the spinal cord and locomotor training. Epidural stimulation is the application of continuous electrical current at varying frequencies and intensities to specific locations on the lumbosacral spinal cord. This location corresponds to the dense neural networks that largely control movement of the hips, knees, ankles and toes. Locomotor training aims to ultimately retrain the spinal cord to ‘remember’ the pattern of walking by repetitively practicing standing and stepping. In a locomotor training therapy session, the participant’s body weight is supported in a harness while specially trained staff move his or her legs to simulate walking while on a treadmill.
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NEWS ANALYSIS
Is the new Apple Watch really a medical device?
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hen Apple made its first foray into the wearables market back in 2015, the world went a little bit crazy for the tiny device that offered the ability communicate as well as offering up a health have and fitness companion at the same time.
Press reports highlighted the Series 4 Apple Watch’s new FDAcleared features and focussed on its use a potential medical device. Lu Rahman looks at what the product offers and is somewhat sceptical of its latest labelling
“Apple Watch begins a new chapter in the way we relate to technology and we think our customers are going to love it,” said Tim Cook, Apple’s CEO. “We can’t wait for people to start wearing Apple Watch to easily access information that matters, to interact with the world, and to live a better day by being more aware of their daily activity than ever before.”
“Conceived, designed and developed as a singular product, Apple Watch merges hardware and software like never before,” said Jony Ive, Apple’s senior vice president of design. “In Apple Watch, we’ve created three beautifully curated collections with a software architecture that together enable unparalleled personalisation in a wearable device.”
Fast forward to 2018 and the Apple Watch had continued to evolve and is taking on a new role - as a medical device. According to its maker: “Apple Watch Series 4 with watchOS 5 brings advanced activity and communications features, along with revolutionary health capabilities, including a new accelerometer and gyroscope, which are able to detect hard falls, and an electrical heart rate sensor that can take an electrocardiogram (ECG) using the new ECG app, which has been granted a De Novo classification by the FDA.” The Series 4 watch is arguably the company’s most health-conscious device to date, offering features that has seen the FDA clearing the product as a Class 2 medical device. The Verge, explains the De Novo classification via Jon Speer, the Greenlight Guru: “Historically, claiming something is “de novo” is a less common way of getting devices to market, but it’s becoming more popular, adds Speer, as we blend fitness gadgets with emerging technology. We’re going to continue to see these wearable technologies cross over and become regulated as medical devices… Think about things that are indicators of your health: blood pressure, heart pressure, respiratory rate, maybe things like diabetes management. The possibilities seem endless.”
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According to Fortune, Apple sold eight million Apple watches in the final quarter of 2017. “We’re thrilled Apple Watch has become an essential part of people’s lives,” said Jeff Williams, Apple’s chief operating officer. “The completely redesigned Apple Watch Series 4 continues to be an indispensable communication and fitness companion, and now with the addition of groundbreaking features, like fall detection and the first-ever ECG app offered directly to consumers, it also becomes an intelligent guardian for your health.” The features are an advanced ECG for heart monitoring, and the capability to notify the user of an irregular heart rhythm. There are some provisos however, as you can’t use these functions unless you’re over 22, and the irregular heart rhythm capability is only designed for people who haven’t been diagnosed with atrial fibrillation. One question I have - can this really be a medical device? Well Apple did its groundwork and in order to create a product that could identify irregular heart rhythms, it set up a study (albeit small, with 600 participants) with Stanford Medicine so that the technology could be fine-tuned and used to detect conditions such as atrial fibrillation. The Class 2 classification highlights that the device will not fatally affect a user if it doesn’t work, unlike a Class 3 product. So the jury’s out on its usefulness as medical device. Clearly highlighting that a person has an irregular heart rhythm is valuable, however, those with a pre-existing condition would obviously need a more sophisticated product as this device is unsuitable. In terms of monitoring trips and falls, again, this is a useful feature on the new watch. However, in the UK. There are a range of initiatives that the NHS is rolling out that cover this type of injury such as gyroscopes in the form of wearables that help measure an elderly person’s gait and which mean a physiotherapist can create an exercise programme that reduces the risk of a trip or fall.
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While the Series 4 Apple Watch is a great device with new useful features, I’m not sure we’ll see healthcare professionals relying on its data anytime soon.
Learn more at www.dow.com/medicalsolutions 9
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BIOABSORBABLE POLYMERS
Biorabsorbable polymer mesh gets FDA seal of approval
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urgical Innovation Associates (SIA), a start-up medical device company, has received 510(k) clearance from the US Food and Drug Administration (FDA) for DuraSorb Monofilament Mesh. It is said to be the first in Surgical Innovation a line of advanced Associates receives FDA bioabsorbable technologies for clearance to market reconstructive and advanced bioabsorbable cosmetic surgery.
mesh for reconstructive and cosmetic surgery
Each year, more than 1 million Americans are implanted with surgical mesh to provide the soft tissue support that is necessary in a variety of general and plastic surgical procedures. Much like an absorbable stitch, DuraSorb Monofilament Mesh is designed to integrate into the patient’s tissue – providing strong support during the critical initial phases of healing – and then slowly dissolve, leaving the patient free from foreign material within one year. The device brings polymer science and evidencebased engineering to bear on a material that has been used in other surgical applications for decades. DuraSorb will be released in select geographies in early 2019.
“The idea of a mesh that is there when you need it and gone when you don’t, is appealing, for much the same reason that absorbable sutures have become a key part of a surgeon’s armamentarium – tissue support from a foreign material is crucial during healing, but at some point thereafter may become a liability,” said Dr John Kim, inventor of the device and professor of Plastic Surgery at Northwestern University. “This technology was developed in direct response to unmet clinical needs in our field.” Complications following mesh placements can range from longterm pain to non-healing wounds. Historically there has been a dichotomy between permanent synthetic meshes and biologic meshes. Permanent synthetics provide favorable long-term support in hernia surgery and abdominal wall reconstruction. However, they are known to expose patients to long-term risk of pain, non-healing wounds and complications during later operations. Biologic meshes – derived from human or animal cadavers – promise long-term biocompatibility once they integrate into the patient’s tissue, but carry excessively high cost, risk of
adverse inflammatory reactions and mixed clinical results. “Having known people who have gone through the pain of multiple mesh-related operations, I found it gratifying to collaborate closely with opinion-leading surgeons to make DuraSorb a reality,” said Alexei Mlodinow, CEO of SIA. “Their guidance went into every key decision during product development, and will now steer our clinical trial strategy as we replicate our robust preclinical data in a realworld setting.”
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The idea of a mesh that is there when you need it and gone when you don’t, is appealing, for much the same reason that absorbable sutures have become a key part of a surgeon’s armamentarium”
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OPERATIONAL EXCELLENCE IN MANUFACTURING
MANUFACTURING REDEFINED. At Freudenberg Medical, operational excellence is a mindset, an approach and a philosophy to continuously improve product quality and the efficiency of our processes and services. Our customer-centric manufacturing transfer process ensures that needs and expectations are explicitly documented, translated into requirements, and project plans are executed on-time and within budget. From next-generation designs, enhancements to production, and scale up for volume manufacturing.
CATHETERS. COMPONENTS. COATINGS. freudenbergmedical.com
ALL IN A DAY’S WORK
MANAGING DISRUPTIVE TECHNOLOGY What is disruptive technology? Upon hearing the term, one might think the connotation is distinctly negative. Disruptions tend to conjure up thoughts of chaos or unwanted interruptions. While these associations can most certainly be true, a slight change in perspective could yield a more positive impression and provide an opportunity to turn the proverbial lemons into lemonade. WHAT HAPPENS TO US Initially, we look at disruptive technology as something that is happening to us. It is as if we have been hit by a surprise and the plans we have been working towards are now questionable. This can be devastating if the goods or services we provide will now somehow be replaced and make our work irrelevant. In response, most worldclass organizations work to anticipate. It is not always obvious what may come, but it is necessary to be in an adaptable position when it does. The obvious place to start is by keeping track of what your competition is doing. What are they offering? Where do they appear to be heading? An evaluation of the competitive marketplace should not only provide insight but help shape an idea of what is necessary to focus on. Next, look at the complementary technologies around you. Ask yourself: “What is the most difficult process or skill that our company touts as an expertise?” Then, search the industry to see if someone is offering an alternative
ALL CHANGE
approach that could diminish your current advantage. When did the film industry first think that the invention of digital memory technology would change photography forever? When did they take it seriously? Do not let your company wake up one day on the wrong side of change. Lastly, look to academia. If there are colleges or universities talking about your industry, you need to know what they are saying. Sometimes, it is easy to dismiss these ideas or conversations because there are often daunting gaps between what happens in the lab and what is commercially viable. However, if someone is thinking of it now, the solution may be closer than you think. Attend conferences and symposiums occasionally to keep tabs on what the PhDs are saying about your industry. You might even what to hire one. WHAT WE MAKE HAPPEN On the other side of the coin, are the disruptions we make. What is one man’s hassle is another man’s gain. Nothing is better than the change we impose on the market, especially if it will be in high demand. The challenge is to take this concept and internalize it a bit. Sometimes we stumble upon breakthroughs, but stumbling isn’t a strategy. It is great when it happens but is not much of a plan. I have never read a corporate mission statement that declares a goal of hoping to find good work – but sometimes, this is how we act.
Aaron Johnson, Accumold, looks at ways to harness disruptive technologies and make change work to your advantage
Do you ever feel like there is a “Do Not Disturb” sign on your organization? Sacred cows, traditions, “the way things are done,” are all competitors to change. Sometimes, “the way you’ve always done it” is still the best way, but how do you know? Your customers, your competition, the marketplace do not care about your sacred cows and traditions. They only care about what brings value to them right now. They are working hard to disrupt you. Are you working just as hard to disrupt you too? One of my favorite authors, Jim Collins, talks about “productive paranoia” in his book Great by Choice. Basically, work smart. Work as if your competition is right on your heels, but do not be reckless about it. Think of disruptive technologies as competition and let it keep you on your toes, keep you focused and help drive your organization to greatness. Embrace change and use it to your advantage.
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COVER STORY
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he In Vitro Diagnostics (IVD) industry has seen tremendous change over the last decade, triggered by many factors including the global financial crisis; the Affordable Care Act, PAMA, and Clinical Lab Fee Schedule reforms. In turn, IVD manufacturers were forced into cutting internal and external costs to make up for slow growth in the US and European markets. During that time many larger companies turned to manufacturing design houses to aid the design process, not just for the devices but the consumables themselves. Understanding the go-to market strategies, restrictions, and rigors of healthcare companies is important in appreciating the complexities they face on a day to day basis.
THE IMPORTANCE OF CUSTOM MOLDING
Elizabeth Roberts, Currier Plastics, outlines the importance of custom molding from start to finish in the IVD industry
When manufacturing medical / IVD plastic consumables, there are many with the processing capabilities for molding these types of products. Engaging at the concept stage can make the difference to how successful you are in the market. You need an organization with the right combination of results-driven talent and technology to help you reach your potential in the shortest time possible. To be able to serve the medical and IVD community at large demands the molding expertise to be able to properly develop the form, fit and function of the plastic component. Whether it’s a leak-proof bottle and closure, or a multi well tray, the burden must be taken off the OEM by providing a product that meets the specified user requirements and with zero defects. This can be achieved through early concept design review and collaboration, component prototyping followed by quality-driven production molding. Working with a molder who can provide a hassle-free approach includes being in direct contact with expert molding engineers who are responsible for the product from concept throughout the manufacturing lifecycle and who remain engaged throughout the production process, as changes will invariably occur as the project takes life. The design and build of the production tooling are paramount to a repeatable molding process. It begins in the prototyping stage before any steel is cut. Predicting how the part will perform in and out of the mold is part of Design for Manufacturability (DFM). Maintaining component part aesthetics for the human factors like ease of use and cost effectiveness, other key factors in the manufacturing process need to be evaluated as well. These factors include mold ow, tool design and complexity, draft, and optimal wall thickness for performance by the end user. Material options should be considered that could positively affect performance and reliability. Early involvement using a DFM process produces better part-to-part consistency and can reduce mold costs significantly. The DFM process includes using tools to develop the user requirements that must be established early in the process:
COVER STORY
FEA Finite Element Analysis-shows whether the product will function as designed, analyzing the effect of vibrations, fatigue and heat transfer. DFMEA Design Failure Mode and Effect Analysis – systematic approach to failure analysis. MOLDFLOW An injection molding simulation tool used for improving both part and mold designs, and the manufacturing processes. SOLIDWORKS 2D and 3D solid modeling computeraided design and computer-aided engineering computer program AUTOMATION During the development phase of the program, full automation may not be required for producing components but will become necessary as the program reaches maturity. This can begin with the hand assembly and grow into hands free automation when in full production. PACKAGING METHOD How the product is handled once it reaches the destination facility is important. There should be a verification tour to examine the filling line automation and ask the qualifying questions. What works for one customer won’t work for another. The goal is to optimize packaging so the product can readily be used. Sample parts can be provided using a variety of methods including 3D printed models and building single cavity prototype molds. While your focus is on the approval process by the FDA and other regulatory agencies, your molder should be able to provide the samples to use while qualifying your IVD instrument, filling lines, etc. During the first year, prototype molding and hand assembly may be used for the shorter runs during the qualification process. This pilot manufacturing enables you to design and qualify your production equipment using the sample models for testing.
This step allows: � Get to design approval quicker � Low volume flexibility � Qualification processes accurately defined � Sellable parts PRODUCTION A molder with a broad range of molding machines give you flexibility in component size and annual volume capacity. Injection stretch blow molding (ISBM) using PET material gives your product a glass like appearance. Extrusion blow molding (EBM) with PE material is more opaque. Thin and thick wall designs are possible with a variety of geometries and neck finishes. Your injection molding (IM) partner should have experience processing a full range of specialty-engineered thermoplastics to optimize your components plastic design requirements for medical/ IVD instruments. Over the course of a year, we may speak to several hundred engineering and purchasing teams who are looking to partner with a custom molder who can support their goals. They work with global suppliers who are on different time zones, already have multiple customers they are trying to support, and layers of red tape to get through to make a decision. This can slow down the manufacturing process. At Currier Plastics, we’ve created a culture of integrity and mutual respect for our co-workers, our customers and our community. Our V² symbol is defined as Value x Velocity. As a business we are driven to provide two elements of outstanding capabilities to our customers; speed or true velocity in everything we do multiplied by superior value that incorporates total quality, operational efficiency and established organizational core values. The demands of today’s IVD customer does bring challenges to our organization to be able to respond increasingly faster to their requests for custom molded plastics. There are hundreds of injection and blow molders in the US but there are less than 30 that do both and fewer that offer it from a single location. At Currier Plastics, we offer molding expertise in ISBM, EBM and IM. We currently have a 128,000 sq ft facility in central New York and have an expansion planned over the next three years to add much needed manufacturing and warehouse space. The FDA rules and regulations will be changing again in the next few years creating a more stringent environment and possibly a few more reams of documents to be completed before testing and approval are granted for production and release to the scientific and medical communities. This may see IVD consumables taking on different shapes as the form, fit or function is challenged.
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Brilliant performance | ENGEL medical
Medical technology is an industry apart. Maximum product safety, absolute cleanliness, precision in production, and complete documentation are essential requirements. No compromises. After all, it’s a matter of health, quality of life and life itself. At ENGEL, we provide precise solutions to meet these stringent requirements. Offering all-electric, hybrid or servo-hydraulic machine models, and a complete range of cleanroom and automation equipment, ENGEL provides the high performance package to suit your application. With ENGEL medical. It’s a matter of life.
www.engelglobal.com
REGULATORY AFFAIRS
Seeking approval MAIK ENDLER, KNOELL GERMANY, EXAMINES THE CHALLENGES FOR START-UPS GAINING MEDICAL DEVICE APPROVAL
P
utting medical devices onto the market is complex and expensive. This is a particular challenge for small companies and start-ups, whether as a result of global and national regulatory demands, the associated requirements for staff qualification, or the provision of sufficient capital. How can you satisfy these demands without losing sight of the goal of bringing your product idea to the market as quickly as possible? As a consulting business, the Knoell Group has been dealing with these questions for a number of years and has developed methods for addressing them in an efficient and customer-oriented manner. Smaller businesses are usually focused on their core competence – generally the development of new and innovative medical device technology. Owing to their lack of experience with regulatory demands, certain points are not taken into consideration sufficiently during development. Normally, prototypes or products almost ready for series production are manufactured without taking medical device approval into account. It is at this juncture that most companies begin to tackle approval issues, and then realize the range of demands is broader than originally assumed. This can lead to delays or the cancellation of the project for lack of profitability. Often a decision is made at the beginning of the project to forgo the assistance of consulting services providers. Few consulting companies can provide comprehensive product-oriented advice going beyond the regulatory demands. There is a practical disconnect between regulatory demands and concrete implementation in an actual product. The essential phases of product development together with their core aspects need to be worked out, and insufficient attention is usually paid to them. There is a lack of the overall view of the procedures that need to be followed to develop a compliant medical device. The main phases are the conceptual planning phase, the specification phase, and the verification and validation phase including clinical assessment, and possibly conducting clinical studies. CONCEPTUAL PLANNING During this phase, customer requirements are determined, the regulatory strategy is defined, and these form the basis for identifying development requirements. Little effort is applied during this phase. Sometimes it is often skipped, although it is in this phase that the scope of all subsequent activities is defined and development strategies may be prepared thanks to the choice of requirements that allow an
efficient path through to approval to be taken. Possible variables include the choice of markets for initial approval as well as the product’s specific purpose. Both factors influence the requirements, the scope of verification and validation, and the product’s time to market. Available capital, which needs to be used efficiently by start-ups, also plays a major role. SPECIFICATION PHASE If sufficient care has been taken with the conceptual planning phase, the specification phase should provide no major challenge. However, inadequate specifications will be defined without the corresponding preparatory work. This includes, for example, the choice of materials. These are usually selected to satisfy technical requirements. However, insufficient consideration may have been given to the biocompatibility of the materials, which may result in the specifications being revised at a later date, in repeat verifications, and in delays and additional costs. VERIFICATION AND VALIDATION PHASE The verification and validation phase provides supporting evidence. The specifications first need to be verified against regulatory demands (eg performing biological, mechanical and electrical tests), and second, validated against customer requirements. This evidence is generally provided by performing standard tests. However, it is important to ensure that verification activities match the specifications and regulatory requirements. This coherence is generally lacking, resulting in queries and possibly in deviations following assessment by the approval authorities. Validation of customer requirements is usually neglected, which is normally covered by usability validation. Besides development requirements, this is the area that is most often neglected in product development. Companies are insufficiently aware of the significance of fitness for purpose. However, it constitutes the connection between the developed product and the designated application, the intended purpose. Inexperienced companies should look for partners who cover the spectrum of consulting services across all phases of product development. Additional support from a consulting company in coordinating tests and the scientific exchange of information between service providers (testing laboratories, clinical research organization) can create freedom for companies to concentrate on their core competence. All this results in highly efficient, costoptimised approval concepts and significant competitive advantage.
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BREAKTHROUGH DEVICES
L
ondon-based architects Tonkin Liu has used its architectural expertise to invent a medical device. The practice, founded by partners Anna Liu and Mike Tonkin, has created a prototype stent for use in the trachea. The stent is a new type of shell lace structure – the practice’s signature single-surface structural technology designed and developed through a decade of research for architectural and engineering applications. It uses biomimicry to abstract principles from natural structures such as molluscs and plants.
Tracheal stents are commonly used to support transplants of the trachea and to treat collapsed airways in instances of throat cancer, trauma (eg car crash victims) and for the elderly. Stents are typically manufactured as a non-tailored tubular mesh, which due to poor fit makes them prone to slippage, causing injuries and infection and often requiring frequent replacement. The shell lace stent has been prototyped and developed using digital design software and 3D-printing technologies commonly used for architecture projects. The stent design is C-shaped rather than tubular, meaning its geometry can better adapt to the unique physiology of each patient. It is designed to be manufactured from medical grade silicon, with a perforated surface allowing for breathability and drugdelivery to the trachea tissues.
Working with engineers Arup and scientists from the Natural History Museum, the practice has developed a digital design and manufacture technology to make architectural sheet materials perform as efficiently as natural structures. Since 2008, the technology has been used in the design of ultralightweight pavilions, bridges and towers, and now for the first time to create a medical device. The perforated structure of the shell lace stent
From buildings to medical device:
HOW THESE ARCHITECTS CREATED A HEALTHTECH BREAKTHROUGH It’s not often we hear of a medical device being inspired by an architectural application. Architects Tonkin Liu have done just that however, to create a product that could help people with throat cancer or trauma
The flexible nature of the shell lace stent mimics natural process to ‘unfurl’ to create an optimal fit for each patient once deployed
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BREAKTHROUGH DEVICES
The stent is inserted in its inverted position, and then unfurled to provide a flexible and strong fit, with a natural outward pressure that lessens the risk of migration – a feature that the architects designed after analysing the geometric principles of Calla Lily petals. In 2014, Tonkin Liu published a book The Evolution of Shell Lace Structure to coincide with an exhibition of all its shell lace projects to date at the Royal Institute of British Architects. During a talk the architects gave in the exhibition programme, a clinical research scientist questioned whether the structural technique could be applied to the design of a small medical device, and soon after the practice’s quest to collaborate with the medical profession began. Obtaining funding from government-backed agency Innovate UK in 2016, the practice set about creating prototype stents using 3D-printing. To be suitable for medical use, the resulting shell lace structure was 500 times smaller than those previously created for any architectural applications. Partner Mike Tonkin comments: “This project is small in scale but grand in ambition. It demonstrates how architects can apply themselves beyond architecture – how we candesign things other than buildings. We hope now to bring the shell lace stent to manufacture and we can design things other than buildings. Our aim is now to bring the shell lace stent to manufacture stage and see it bring tangible benefits to patients globally. Tonkin Liu’s designs for the Manchester Tower of Light (left) and Oval Court at the Lansdowne Club (right) demonstrate the shell lace structure in architectural form
Mike Tonkin and Anna Liu WITH THE SHELL LACE STENT PROTOTYPE
“We need to collectively reimagine the role of the architect – the architecture sector has great potential to engage with different realms and professions. As we all live longer and make greater demands on the medical profession, we should all look to use what skills we have (in our case advanced digital design and fabrication) to collaborate and benefit society.” With its inverted surface and structure and other novel features, the prototype has drawn excitement from leading medical experts. Professor Martin Birchall, UCL professor of laryngology and consultant in ENT Surgery at the Royal National Throat, Nose and Ear Hospital heralded it as “a remarkable and unprecedented stent invention, that is groundbreaking in the context of currently available devices.” Following numerous design iterations and successful testing, the shell lace stent has now been approved as patent pending. Tonkin Liu is working with research partners and medical experts to bring the innovation to market, as well as exploring broader applications of the technology for other parts of the human body.
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MICROMOLDING
clearing
the way
Lindsay Mann, MTD Micromolding explains how to overcome roadblocks when producing a micro medical breakthrough
MICROMOLDING
W
hen trying to produce an innovative micro medical design, you may come to a roadblock. What can you do to move forward and get the project back on track? First, determine the source of the problem. Is your supplier having problems? Is there an issue with your design? Some common warning signs your supplier may be failing are: failing validation; not achieving lot-to-lot consistency; told your design is “impossible”; asked to make numerous design compromises; lack of communication; same issues cropping up; time between communication is getting longer and longer; feeling you know more than your vendor, and lead times between samples getting longer – showing disinterest OVERCOMING SUPPLIER ROADBLOCKS If your supplier is failing, it’s time to ask the tough questions. Is it truly feasible for your supplier get your product back on track, or will you spend months or years without making progress? Even though you’ve invested time and money with your current supplier, sometimes the best strategy to get your product to market faster is to find a new supplier who is better equipped to address your product’s specific needs and challenges. While it seems like a major expense to change suppliers, it will likely save you money in the long run if your product gets to market faster and efficiently. Sometimes the molder simply doesn’t have the specialized medical micromolding equipment needed to produce a particular design. Sometimes they don’t have experience or expertise in working with a certain material or challenging design. Other times, a supplier may excel at low volume or on-demand production but cannot efficiently ramp up production. What does it cost to not do it right the first time? We worked with one of our customers to calculate what it actually cost their company to have their project rescued from a failing supplier. This OEM had developed a concept for a bioabsorbable fixation device that generated excitement and positive comments from reviewing surgeons. Although the company worked with a reputable molder, after five years of labor, the molder had limited success and could not produce the part represented in its drawing with sufficient quality. After the five years, the OEM decided to cut its losses and start fresh with a different molder. When the OEM tallied its losses, the results were staggering. Factoring in an estimated one-year delayed market entry, the loss of potential product sales, the time unnecessarily spent in process development, and the cost of restarting their project with a new molder, the sum came to about $1.5 million. OVERCOMING DESIGN ROADBLOCKS Are you requesting ‘no flash’? Requiring extremely tight or challenging tolerances? Assigning a challenging gate location? If so, you may be causing your supplier to chase their tail to solve the problem – or you may be incurring a huge increase to budget and lead time. Is it worth it? Sometimes simple drawing concessions can help.
Inadequate material choice frequently leads to manufacturing issues. There are polymers that demonstrate high compressibility, poor fill properties, poor long term dimensional stability. Tight tolerances like +/- .001” may be difficult to achieve with these materials. Your design and drawing will dictate what materials can be used. If you’re tackling design roadblocks, talk to your supplier. They should be able to guide you on better material choice or simple design concessions that will help meet the goals of your part’s functionality. HOW CAN YOU DETERMINE WHAT’S COMPLETELY UNREALISTIC VS. PUSHING BOUNDARIES? Engage early. Get a clear understanding of whether your design can translate to injection molding by engaging your molder as soon as possible – and if it can’t, understand why not. Push the boundaries. Go to industry experts to understand what elements of your design realistically possible and what boundaries can be pushed. When requesting quotes for a micromolding project, ask molders to show similar examples of parts they have created that are similar to your design. Go with the ‘true positive’. A molder that is open with concerns and can present options for manufacturing success should be more comforting than a molder with zero concerns or interest in drawing optimization. Don’t make assumptions. Bring your grand ideas to your molding partner and discuss your wishl ist for your design(s). If you allow the molder to evaluate what is possible and realistic as a long-term molding solution, they can listen to your expectations and provide substantive feedback. HOW CAN YOU EFFICIENTLY WORK WITH A MOLDER TO PRODUCE YOUR BREAKTHROUGH IDEA? Consult early. Consult your molder early in the development process and, if possible, be open to some flexibility in material, dimensions, and timing in order to increase speed to market. Come prepared. Know what you need for your part with a high level of understanding about the product’s requirements. Express areas of the design you feel are challenging and/or have concerns about to your molder. You understand the limits of your design and the edges of success and failure. This information allows the supplier to assess how they can help from the most productive angle. Be mindful. Extremely difficult geometries typically require some kind of unconventional approach to the project in order to be successful. Having an understanding of the technology, experience, and knowledge required to create these complex geometries in plastic will help you save you time in your supplier qualification process.
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STERILIZATION
Understanding the importance of TIR17 for medical device manufacturers: TIR17 has evolved over the years to be a necessary resource for device manufacturers, says Wendy Wangsgard, Nelson Labs
M
aterial selection is one of the most important considerations for healthcare product manufacturers, specifically medical device manufacturers, because it impacts design, manufacturing and sterilization. When choosing a material for a device, manufacturers need to consider which works best with the design, which can be used in the manufacturing process, the effect sterilization will have on the material, the possible impact of the material on the intended device function, and how sterilization affects packaging and accelerated ageing of the material. TIR17 BACKGROUND These factors, as they pertain to radiation (gamma, electron beam, or X-ray) sterilization, were considered by the Association for the Advancement of Medical Instrumentation (AAMI) when originally publishing the 1997 document Technical Information Report (TIR) 17: Compatibility of materials subject to sterilization.
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STERILIZATION After 11 years, an updated version of TIR17 was revised to include: • Additional sterilization modalities: ethylene oxide, moist heat (steam), dry heat, hydrogen peroxide and ozone; • A list of compatible materials to aid in the selection process was provided in the annexes; • Information regarding how each modality may work for pharmaceutical and biological agents; • With the advent of combination devices, accelerated stability programs for pharmaceuticals was compared with accelerated aging programs for devices. • The latest version of TIR17 now includes additional guidance for nitrogen dioxide, peracetic acid vapor, liquid peracetic acid and hydrogen peroxide-ozone sterilization modalities. ORDER OF DOCUMENT TIR17 provides guidance on four main areas: Choosing sterilization-compatible materials; avoiding processing errors by optimizing the functionality of the selected materials; assessing functionality and safety of the product following sterilization and aging, and reducing the cost and time needed for material qualifications by applying accelerated aging programs that correlate to real-time aging. CHOOSING STERILIZATION-COMPATIBLE MATERIALS Section 3 provides general information manufacturers can use to evaluate the compatibility of materials with each type of sterilization. The information in the document is not comprehensive since it does not address every application or how the combination of multiple materials may affect the choice of sterilization modality. Throughout the section, the information is presented as follows: • background • typical use • process parameters and variability • general material compatibility (including tables) • pharmaceuticals and biologics • packaging A description of the mechanism of action is also included. For any modality, the vendor, distributor or manufacturer of the selected material should be consulted. MATERIAL PROCESSING General considerations for manufacturing processes and design considerations are detailed in Section 4. The functionality of polymeric materials may be affected more by processing variables (molding, extrusion, film calendar, subassembly and product assembly) than by sterilization modality.
Since polymers tend to fail at the point of greatest cumulative stress, which can be a combination of stresses and environmental exposures, a list of the variables to consider is provided. When evaluating manufacturing processes such as molding, extrusion or calendaring, care should be taken to ensure that the quality of the material is not compromised. Regardless of the sterilization modality, the stresses associated with poorly processed material can reduce the performance. Inconsistencies found in literature regarding the compatibility of materials with sterilization can be due to the variability that occurs with processing. Care should be taken when designing a product to ensure that the chosen sterilization process can be efficiently implemented. If a product is intended to be sterilized using gas or vapor, it should be designed such that the areas to be sterilized are accessible. Presentation of the product to the sterilization process can be affected by mass and loading density. For all manufacturing, environmental and sterilization processes, critical failure modes should be analyzed and understood. MATERIAL TESTING & PACKAGING General considerations regarding material testing should always include product functionality and biocompatibility. An awareness that some common generic material names can refer to a family of chemical compounds is important as compatibility can be affected by variations in chemical composition. Functionality requirements should be determined and specified. Failure modes need to be identified and documented before shelf-life testing is performed. Function and safety of materials and products should be established using worst-case sterilization processes. These conditions can include dose, temperature, humidity, pressure, time and sterilant concentration, and will vary based on the sterilization method. A maximum acceptable dose will need to be established if radiation sterilization is utilized. Section 5.4 addresses factors related to device and package integrity testing. ANSI/ AAMI/ISO 11607 addresses packaging integrity testing, and Table 29 outlines test methods that can be used for functionality. Testing should include challenging the identified critical failure modes, yielding variable data (required to iterate an aging factor [AF]), represent routine production, defined acceptance criteria, statistically valid sampling numbers and a written protocol for accelerated aging conditions.
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Section 5.5 provides considerations related to material biocompatibility, including material characterization and toxicity testing. Detailed information regarding biocompatibility can be found in the ANSI/ AAMI/ISO 10993 series. Screening tests that are relatively inexpensive and rapid can be performed early in the design phase and provide information about potential biosafety issues that could help avoid redesign of the product. Material suppliers and databases can be a good source of information to reference when evaluating candidate materials. Chemical characterization can also be used to screen potential materials and provide data regarding biological or toxicological components. Although information regarding packaging is detailed for each sterilization process, careful consideration should be given for packaging to ensure it enables sterilization and sterility. The requirements that must be met are allowing for sterilization, allowing for sterilant residual removal, and maintaining sterility throughout shelf life. Essential packaging properties should include breathability with regard to gas sterilization, density with consideration not only to number of products in a pouch but also the number of pouches in a carton, the number of cartons in a box and the number of boxes on a pallet. Density may not only greatly affect penetration of sterilant to a load, but could also affect temperature, humidity and aeration profiles. It could also impact the dose uniformity to product when using radiation as the sterilization modality. Additionally, packaging material functionality needs to be addressed for the sterilization method that is chosen. ACCELERATED AGING The last section of this TIR provides information about accelerated aging products. Product functionality and performance need to be maintained throughout the defined lifetime of a medical device. While real-time aging is the most accurate reflection of shelf life, the time involved does not allow valuable technology to benefit patients. Therefore, accelerated aging is widely accepted in the medical device industry. Although the original guidance was developed for radiation sterilization, the concepts apply to all sterilization methods. With the addition of more processes, guidance for these programs is now found in Annex J. Given the vst amount of valuable information contained in TIR17 regarding material compatibility with a variety of sterilization modalities and an extensive explanation of accelerated aging programs, any medical device manufacturer should have this document at their fingertips.
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STERILIZATION
Morgane Lagneaux, Velox, outlines the sterilization considerations to bear in mind when choosing a particular medical plastic
choice words P
lastics react differently to various sterilization methods. Therefore, when selecting a material for a new medical device, you should ask yourself if the component will undergo sterilization and if so, which method of sterilization will be used? Also, how many times will it be sterilized? The most common sterilization methods are ethylene oxide (EtO), irradiation (gamma/e-beam) and steam autoclaving. There are also other alternatives such as STERRAD and vaporized hydrogen peroxide (VHP). The majority of thermoplastic polymers can withstand exposure to EtO without displaying any significant changes to their properties or color, even if some dimensional changes are possible, as EtO is typically done in presence of humidity at around 55°C. It should be noted that the device undergoing EtO sterilization should have a gas permeable packaging allowing the gas to go through it and therefore reach the device to efficiently sterilize it. However, gamma/e-beam sterilization in the majority of cases will alter the optical appearance of the polymer – mostly a color shift towards yellow: In addition, it may change the mechanical properties of the material such as tensile strength, impact strength and elongation. For instance, standard polypropylene (PP) grades may not be suited for radiation sterilization due to their loss of physical properties and discoloration that takes place immediately after sterilization and can worsen over time. To overcome this issue, many polyolefin producers such as Repsol, have developed grades stabilized for gamma radiation. A color shift is not always an indication of loss of mechanical properties. In terms of mechanical performance, polycarbonate (PC) is generally resistant to radiation but it will turn yellow when sterilized. A common trick among polymer producers is to add a small amount of blue/violet pigment where the color shift then results in a more pleasing ‘gray’
26
color. Also the color shift is generally proportionate to the gamma dosage. If the part is sterilized at 50 or even 75kGy, the discoloration will be more pronounced than at 25kGy. Polycarbonate producers, such as Trinseo, have therefore developed grades with different tints to help compensate for color changes after sterilization at various radiation doses. Also the yellowness diminishes with time. After exposure to gamma radiation, the transparent PC parts equilibrate back toward their original color prior to irradiation but this can take several weeks. The most challenging sterilization method remains steam sterilization/autoclaving as many thermoplastic polymers are sensitive to heat and hydrolysis. Some materials will lose structural integrity when exposed to high temperatures of 121°C to 134°C. Even parts using plastic materials with a softening temperature higher than the autoclaving temperature can suffer from the release of molded-in stresses resulting in dimensional instability and/or warpage. Therefore, devices intended to undergo steam sterilization should be made of heat-resistant materials and a special care should be taken regarding the molding in order to avoid residual stress. Another precaution is to consider the chemistry of the thermoplastic polymer – under high temperature and pressure
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STERILIZATION
in the autoclave - what can be potentially released from the thermoplastic part in terms of additives or what chemical changes can occur in the polymer structure itself. It is vital to know if there is a risk of formation or release of potentially hazardous substances (eg. aromatic TPUs can form MDAmethylene dianiline – a known carcinogen and so are not recommended for steam sterilization). Materials such as PP, PC and polyarylamide (PARA) can be used, but special care is required in regards to how many cycles they will be exposed to. PP can typically withstand autoclave when correctly molded but is not recommended for repeated sterilization. PARA is also not recommended for steam autoclaving for more than a few cycles as the material quickly loses tensile strength. General recommended conditions for steam autoclave sterilization for PC are 1 to 5 cycles at 134°C. After 10 cycles, the instrumented dart impact begins to decrease and the tensile elongation is significantly affected. Multiple steam sterilization of cyclic olefin copolymers (COC) requires a special process to avoid haze. The high temperature and pressurized steam drives water vapor into the matrix of the plastic part. At the end of the sterilization cycle, steam is vented and the cooling phase begins. Since COC is an outstanding water vapor barrier material, water vapor will become trapped in the plastic matrix if temperature rapidly falls. Water vapor condenses forming haze. This effect can be reduced by replacing steam with dry air at elevated temperatures for some time, which allows trapped water vapor to escape and haze to clear. RIGID MATERIAL
STERILIZATION
PRODUCT GROUP
TRADE NAME
EtO
GAMMA
ABS
MAGNUM MED
P
P
NO
ANOBEX
P
P
NO
AMAB COC COC MODIFIED
P
P
(P)
N/A
N/A
P
ISOPLAST
P
P
NO
P
P2
P
RILSAN MED, RILSAMID® MED
P
P
P
IXEF PARA
P
P
P3
CALIBRE, CALIBRE MEGARAD
P
P
P3
CALIBRE
P
P
P3
PA TRANSPARENT
PARA PC
TOPAS TOPASBLEND
RILSAN CLEAR MED
E-TPU
PA11, PA12
STEAM
PC GLASS FIBRE
2
PC/ABS BLENDS
EMERGE
P
P
NO
PC/PET BLENDS
EMERGE
P
P
NO
REPSOL HEALTHCARE
P
P
(P)
PE
SKYGREEN S2008
P
P
NO
PP
PETG
REPSOL HEALTHCARE
P
(P)
P
PS
STYRON MED
P
P
NO
P
NO
SBC ( ) Available for some grades
ASAFLEX Contact clear available upon request
1
P Color shift
2
Limited no. of cycles
3
If the product is not a single-use device, it will most probably be subjected to multiple sterilizations before being discarded, so plastics which possess superior toughness and heat resistance are better choices. Certain blends of COC can for instance withstand exposure to more than one thousand cycles of steam sterilization at 134°C without losing their mechanical and thermal properties. Thus, these products can be considered as potential material solutions for trays, containers as well as handles of reusable surgical instruments which undergo multiple steam sterilization cycles. The table (left) gives an indication of the compatibility of various medical polymers with the most common methods of sterilization. Before selecting a material for a new device, it is necessary to know upfront which sterilization method will be used, as thermoplastics are very different from one another in terms of chemistry and therefore react differently to radiation or heat and moisture. If the selected material is not compatible with the sterilization method, this could lead to failure. Having a close relationship with your qualified polymer supplier will allow you to get the best advice upfront in order to avoid wasting time and money.
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2019
MAY
ADHESIVES
Made to measure: WHEN OFF THE SHELF WON’T DO
Neal Carty, Vancive Medical Technologies, discusses how early collaboration on material selection can lead to bespoke adhesives — a path that may save some headaches in the long run
A
s functional demands on medical devices become more complex, device developers may struggle to find standard, off-the-shelf adhesives that can help them achieve their desired product performance requirements. This article guides developers through some basic considerations to keep in mind during material selection and when partnering with a supplier to get it right the first time.
Under the pressure of an aggressive project schedule, intuition says that an “off the shelf” choice will be faster and simpler. But this is not always the case. An optimal solution to a specific problem often requires some degree of customisation, and it’s important to consider that not every custom product involves the creation of brand new chemistries. There are many cases in which existing adhesives and materials can be combined in new ways.
Product development engineers live in a world of accelerating timelines, shrinking resources and impossible expectations. And they thrive on it. Delighting their customers and fueling their next recordbreaking quarter is what drives them, and they know that winning means using every tool available to be leaner and more innovative in their work.
In other words, a materials supplier may be able to ‘mix and match’ different backings, release liners or adhesive types to achieve the desired performance. By doing so, the device developer can walk away with an adhesive product uniquely specialised for a certain end use, without reinventing the wheel. Certainly, there are also cases that call for development of a completely novel adhesive chemistry, and this can require a closer R&D partnership to co-engineer a solution. Either way, it’s good to engage with suppliers early and leverage their knowledge and experience to solve a particular development problem or achieve a desired clinical outcome.
CUSTOM DOESN’T HAVE TO MEAN SLOW When designers need to specify adhesive materials, the thought of going down a path of customization may sound daunting.
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redefining the limits of extrusion technology... For over 25 years, medical device companies the world over have turned to Microspec for custom extruded parts that challenge the limits of extrusion technology. • SINGLE LUMEN TUBING • MULTI-LUMEN TUBING • BUMP TUBING • RIBBON EXTRUSIONS • CO-EXTRUSIONS • MICRO-EXTRUSIONS • PROFILE EXTRUSIONS • COATED WIRE • TRI-EXTRUSIONS • MULTI-LAYERED EXTRUSIONS • FULLY ENCAPSULATED STRIPES • OVER-EXTRUSIONS • BALLOON TUBING • INTERMITTENT EXTRUSIONS • NEW CONCEPTS
Microspec extrudes most thermoplastic elastomers, including fluoropolymers, engineering resins, and custom compounds. The precision medical parts we extrude are among the smallest and most complex in the industry, with some of the tightest tolerances.
Contact Microspec with your extrusion challenge – we’ll turn it into reality.
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ADHESIVES
EARLY COLLABORATION AND OPEN INNOVATION More medical device businesses are embracing the theory of open innovation as a means to reap the rewards of proactively seeking and incorporating input from experts outside of their own organizations. This can apply to the selection of custom adhesive materials during medical device design and development. A fundamental tenant of open innovation, as explained by one of the movement’s forefathers, Henry Chesbrough, executive director of the Center for Open Innovation, Haas School of Business, University of California, Berkeley, is that: “…firms can and should use external ideas as well as internal ideas, and internal and external paths to market, as the firms look to advance their technology.”(1) In other words, firms can and should leverage the entire universe of resources that is available to advance their goals, not just the ones they have in-house. When device developers and their supply chain partners undertake a design challenge from this perspective, they seek answers from sources who hold the greatest expertise in a specific area. For example, medical device design engineers who need adhesive materials to enable multi-day or multi-week wear times on the skin will benefit from going straight to the suppliers who know the world of possibilities and have the accumulated experience of solving similar problems across a wide array of different applications. In turn, those suppliers should be seeking input from their raw materials suppliers. Each node of the supply chain has the potential to add a new perspective to the conversation. Without this first-hand advice, designers and developers can miss out on key advances and answers that could shorten their development times and help their product perform better for the patient. AVOIDING THE ‘SHOTGUN’ APPROACH In the rush to get products to market, sometimes development teams will request myriad material samples and embark on a program of brute-force experimentation to achieve a desired outcome. This can be referred to as the ‘shotgun’ approach in that companies’ parallel-path testing of a wide array of materials. Sometimes this is effective, but it can quickly sap precious resources and by short-circuiting a process of thoughtful design it can also lead to suboptimal solutions. Often, design engineers can save considerable time and effort by first talking with materials suppliers about their end goals. For instance, it may be very straightforward for a supplier to make changes to an adhesive tape construction: eliminating layers, changing chemistries, or using innovative techniques to give it greater breathability, stronger hold or better conformability — or even something as simple as a different color. By communicating about the end use application early in device development, all parties have an opportunity to avoid designs that are unnecessarily complex or costly.
Open innovation can enable medical device OEMs to secure custom adhesive formulations from companies with extensive adhesive technology
OPTIMISING DIVERSE EXPERTISE Just as the best medical devices and materials are ultimately fit for a specific purpose, the different teams, partners and individual contributors who develop them serve unique roles toward the end goal. For example, wearable device developers need deep knowledge of process engineering to ensure designs can readily scale up to high-volume manufacturing levels. They need polymer and materials science experts to help them achieve the desired wear time, a conformable hold and comfortable release from the skin when it’s time to remove the device. Biochemical engineering and physiologic expertise is essential to ensure proper functioning of complex biometric systems, such as for glucose or cardiac monitoring and drug delivery. Electrical engineering is crucial for understanding device battery life, wireless communication and many other core functions. Whether it’s wearables or wound care, tapping into insights from different subject matter experts can have a big impact on product development. Particularly within the medical device industry, good engineering must go hand-in-hand with an in-depth understanding of the regulatory environment. For example, a medical materials supplier with deep materials science experience in the medical market and a working knowledge of global regulations may be able to help a device developer save time and effort by recommending design approaches that operate within allowable regulatory boundaries. In conclusion, when supply chain partners pool their resources and diverse talents, they can tap into a wealth of multidisciplinary expertise. If off-the-shelf solutions are insufficient to achieve target outcomes, an open innovation approach may prompt device makers and materials suppliers toward custom adhesive development. When this option is explored early, it can help device developers to solve problems better and deliver new patient solutions in an even more efficient way.
Footnote (1): Henry Chesbrough, “Open Innovation: The New Imperative,” as cited on the Open Innovation Community’s website
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EXTRUSION
WHY SHOULD DEVICE MANUFACTURERS CONSIDER EXTRUSION AS A MANUFACTURING PROCESS? TS: I believe that device manufacturers have always considered extrusion as a process central to the development and fabrication of medical devices. With regard to many advanced devices this fact would be diďŹƒcult to overstate! For this reason, many of the device manufacturers vertically integrate extrusion into the matrix of their manufacturing processes not just to possibly save money but to gain added insight into the relationship of the dynamics in the extruded part and how those dynamics affect the fabrication processes in manufacturing a medical device or catheter. Here it is important to keep in mind that there is far more to an extruded tube than its dimensions. How a tube is extruded will affect most if not all of the manufacturing processes involved in fabricating devices. In the case of the catheter device pictured above right, how the tube was extruded will affect the printing on both the catheter body and the extensions. The tipped distal end involves two lumens and two different materials, a clear polyurethane and two barium filled radiopaque stripes. The proximal
end of this tube is over molded and bifurcated and connected two over molded extension tubes. For successful tipping and over molding, the dimensional attributes of the tube must be to specification to ensure smooth uniform tips. The criticality of the dimensional attributes involve more than just an inside diameter (ID) and an outside diameter (OD), but include the location of the stripes and the positioning of the lumen, which must be to specification for tipping and over-moulding to be successful. Thermal characteristics of the raw material is another important consideration when tipping and over-moulding and also should be considered if the part is to be ETO sterilized.
Tim Steele, Microspec Corporation talks to MPN about the benefits and challenges of extrusion and why OEMs should take this process seriously
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EXTRUSION
With many elastomers, part dimensions can change when exposed to the heat the part is exposed to during sterilization, or the heat it may see in a shipping container. This happens because when plastic is drawn down and cooled there is stress frozen into the plastic. To relieve this stress extruders often anneal parts. The part dimensions will change during annealing, but the latent stress in the tube is now gone and future dimensional changes from heat are eliminated. In the design stage of an extrusion process for a new part it is useful to create a matrix of the desired attributes of form and function a particular part may be affected by the extruder and the process. Process control in extrusion must be anticipated. This involves having a thorough and intuitive understanding of the interaction of the raw materials with the extruder and the extrusion tools. Monitoring and saving all process data is critical to developing and validating the extrusion process as it is with any manufacturing process WHAT MATERIALS DOES THE PROCESS WORK BEST WITH AND WHAT ARE THE ADVANTAGES OF THE TECHNOLOGY? TS: I do not see that any particular material works best throughout the medical device industry. Although there are several families of materials that are used extensively throughout the device industry, I would have to say that the raw material selected for extrusion of a specific device depends on requirements of the device’s application. Physical characteristics generally considered first would be shore hardness, flex modulus, tensile strength, melting point, and service temperature. The matrix of material characteristics after that is specific to every application and what would work best in extrusion is largely based upon the competencies of the extruder. In short, what may work best for one extrusion company may not work best for another and to summarize this there is no best material. The use of custom formulated raw materials has been growing, along with the increase in highly specialised devices and advancements in antimicrobial compounds, advancements in drug delivery, and innovation throughout the medical industry. HOW SOON IN THE DESIGN PROCESS SHOULD THE USE OF EXTRUSION BE CONSIDERED AND WHY? Engineering design teams need to start considering extrusion requirements while brainstorming in the concept stage. Having the extrusion expert on the design team and participating in brainstorming during concept development will enhance concept development. This collaborative communication
during the design phase helps the device maker more fully understand what is possible, but also gives the extruder a deeper understanding of the device maker’s expectations. The client and the extruder both benefit and the device gets to market faster. WHAT ARE CHALLENGES OF THE PROCESS AND HOW CAN THEY BE OVERCOME? TS: In the custom medical extrusion world there is not one formula the extruder follows to troubleshoot the extrusion challenges in producing the array of parts being demanded by today’s medical device industry. The devices continue to get smaller and smaller with precision becoming more and more critical. It is the same with functionality. Overcoming new challenges needs to be a collaborative process between the customer (device maker) and the extruder. Overcoming new challenges starts with good communication. Both parties need to have good understanding of the issues so that solutions are based upon intuitive decisions. Of course, both the device maker and the extruder have IP so a Mutual NDA is the first item in the development of a collaborative relationship based upon trust and the knowledge that both sides win by working together. Sharing knowledge is critical to success and both the extruder and the device maker need to be open with each other without giving away trade secrets. HOW CAN EXTRUSION EXPERTS SUCH AS MICROSPEC SHARE THEIR KNOWLEDGE WITH DEVICE DESIGNERS AT AN EARLY STAGE AND CONTINUE TO MANAGE CUSTOMER EXPECTATIONS THROUGHOUT THE PROCESS? TS: By participating in brainstorming during concept development of a new device we have experienced increased openness with our clients. With this our working relationship is strengthened which both sides in understanding the challenges we share in the project. As part of our extrusion service, we offer free technical advice when the client runs into technical problems and, if we do not have the answer, then we will refer to our own network of materials experts to find the answer and get back to the client. SUMMARY: In the medical device industry, the extrusion process and the extrusion engineer are integral to the development of the ever increasing advanced medical devices. The extrusion process is innovating along with the device technology. Sharing knowledge of how extrusion affects device fabrication is critical to making intuitive decisions which will ultimately minimise the time to market for a new medical device.
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MATERIALS
Why innovation matters Roger Hendrick, Healthcare Industry, Dow Silicones Corporation and Carolin Vogel, Specialty Plastics, Eastman Chemical Company, explain how new technology broadens medical device materials and design options
MATERIALS
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o support the growing, multi-billion dollar medical device industry, injection moldable materials suitable for healthcare applications are continuing to improve and expand design options for device manufacturers. New liquid silicone rubber (LSR) technologies in conjunction with copolyester are making it possible to combine the benefits of each technology in overmolding applications. Silicone elastomers have been used in medical applications since the 1940s and have changed to meet the demands of end-use application requirements and processes which manipulate them. The properties of silicone materials can be influenced by their formulation and may provide different application benefits, but generally afford characteristics such as thermal and chemical stability, high gas permeability, hydrophobicity, biocompatibility/ biodurability and high elasticity. While not an exhaustive list, many of these characteristics benefit medical applications and their suitability for various sterilization methods such as autoclave, ethylene oxide (ETO) and gamma or electron beam radiation. FORMULATION IMPROVEMENTS Suppliers of liquid silicone rubber have made formulation improvements since their inception in the 1970s changing to meet application requirements of cured physical properties and their stability when exposed to postprocessing conditions. In some cases, specialty LSR formulations have been developed to impart unique characteristics either in the uncured behaviors or in the cured component. This is evident in new low temperature and self-adhesive LSRs. Copolyesters, as silicones, have several decades’ long history within the medical device industry. Manufactured into medical devices via thermoplastic conversion processes, such as injection molding, their value lies in their unique set of properties. These include: toughness, clarity, their advantageous regulatory profile, such as being free of BPA, and their chemical resistance. THE EFFECT OF STERILIZATION In today’s health care environment, it is becoming more common to see medical devices that don’t work satisfactorily. They are unable to do their job—or fail prematurely—because of environmental stress cracking (ESC) or other defects resulting from exposure to disinfectants and other chemicals. Aggressive disinfectants and sterilization in combination with more frequent disinfecting procedures take a high toll on devices molded with commonly used polymers. Brand owners are addressing this challenge by using polymers with a higher level of chemical resistance. The selection of these highperformance materials early in the design process is one of the most critical considerations for the future of patient safety.1
Testing and evaluating chemical resistance needs to be performed to answer questions around chemical compatibility of materials with various cleaners and disinfectants utilized to maintain medical devices in the healthcare industry. Desirable performance is to have little or no stress cracking or haziness from contact with cleaners and disinfectants, or from lipids, bonding solvents or drugs
and their carrier solvents. Copolyesters as well as silicones have shown being high performing materials regarding chemical compatibility and therefore get chosen frequently in medical device applications. Color-stable, transparent medical devices are of the utmost importance in the healthcare field as they embody the idea of safety, quality and peace of mind for both the patient and the healthcare professional. Though many factors must be taken into consideration when deciding which polymer to choose in the development of a medical device, understanding the effect of sterilization is critical. The objective of sterilization is to reduce the bioburden to a safe level, while minimizing any changes to the physical and optical properties of the final part. The most common effect on polymers exposed to radiation is a shift in color to yellow. In the medical device market, a significant color shift to yellow is undesirable as it may be interpreted as a contaminated device. Therefore, minimal shift in the polymer color after sterilization can be an important factor when specifying a polymer for a medical device or rigid thermoformed package. Various copolyesters are suitable for nonautoclavable sterilization methods such as gamma or electron beam (e-beam) radiation regarding color shift and retention of mechanical properties. BRIDGING THE GAP While heritage copolyesters as PETG, PCTG, and PCTA that were introduced into the market in the last century have heat deflection temperatures (HDTs) in a range of 67°C to 74°C (@0.455 MPa/66 psi; ASTM D 648), newer developments of copolyesters in the recent two decades have higher HDTs of between 94°C and 109°C. This is one necessary step to bridge the gap for over molding copolyesters with silicone. Injection molding with traditional liquid silicone rubber products is commonly done at temperatures near 150°C or greater to assure rapid cure of the silicone component which far exceeds the heat deflection temperature of traditional copolyester preventing traditional silicones from being considered in copolyester overmolding applications. NEW PRODUCT TECHNOLOGIES New liquid silicone rubber product technologies, however are now available to challenge those traditional processing concepts with improved cure rates at low cure temperatures. This makes available the possibility to injection mold with mechanical interlock or with selfadhesive properties at temperatures below critical substrate heat deflection temperatures whilst maintaining necessary cycle times. During a time when an aging population requires new ways to cure diseases and manage chronic conditions, it is important that companies innovate and collaborate to deliver solutions that matter. By merging technologies to meet the needs of manufacturers and ultimately patients, one can positively impact the way healthcare is addressed globally and contribute to greater health outcomes and improved quality of life.
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Lab on a chip helps blood collection in developing countries
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esearchers at KU Leuven are developing a flexible chip that can detect infections and viruses in the blood. It will be of particular use in developing countries. The research group of Professor Jeroen Lammertyn specializes in technology that can detect specific molecules in blood other bodily fluids. The lab-on-a-chip is perfect for diagnosing people where limited medical resources are available. “What’s unique about our design is that it’s simple, which makes it cheap to produce,” says professor Lammertyn. “The device consists of two pliable plastic sheets: in between there’s an adhesive layer that contains micro channels as thin as a human hair. “The chip has two chambers. One contains a liquid which, when it starts flowing, generates pressure in the second chamber. This moves a blood sample into the chip. The fact that no external energy source is needed is an important advantage in developing countries. Our device is activated with the touch of a finger.”
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Med-Tech Innovation Expo venue move aids overseas visitors Registration has opened for Med-Tech Innovation Expo, the UK and Ireland’s leading showcase for medical design and manufacturing technology. This event brings together the medical engineering and manufacturing community; more than 200 companies from all areas of the medical device supply chain engaging with 4,000-plus visitors across two days. The event will now be held at the NEC, Birmingham. It means a larger show with more exhibitors and new features focused on medtech, medical plastics, digital devices, pharmaceutical manufacturing technologies and
early-stage innovations. The expansion of the event is reflected in the conference and seminar programme which will now be held across three stages. With improved accessibility both for UK and international attendees, the organisers are anticipating a step-up both in overall visitor numbers and also in the percentage of those attending from abroad. Holly Delaney, marketing manager for the event said; “We’re so excited for MedTech Innovation Expo 2019. There’s so much on offer in a bigger space with better travel links, more accommodation and even more of the high-quality exhibition stands
our visitors have come to expect. We’re in one of the largest and fastest-growing industries in the world, it's time our community had a show on the scale it deserves.” Med-Tech Innovation Expo will be held in Hall 2 of the NEC, Birmingham (UK) 15-16 May 2019 www.med-techexpo.com
Ohio life science cluster partners with Medilink Midlands to boost trade
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ocated in north east Ohio, the City of Mentor is part of a cluster of life science and biomedical companies that has grown up around the Cleveland Clinic, a leading hospital in the US. The cluster includes companies such as Philips, Siemens, Steris and has over 700 companies based there. The partnership looks to take advantage of the two regions which offer some of the largest clusters in Europe and the US. For instance, the UK has the third largest medical technology sector in Europe, and the Midlands has the largest regional cluster in this sector. Medilink Midlands brings
the collective expertise of over 1,700 life science organisations within the region. Kenneth Filipiak, city manager,
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mentor, Ohio said: “The City of Mentor looks forward to becoming a focal point for stimulating trade and investment between north east Ohio and the UK life sciences sector.” Dr Darren Clark, director of Medilink Midlands commented: “North Eastern Ohio is an attractive strategic location for Midlands companies looking to establish a low-cost foothold in the largest medical and life sciences market in the world. A delegation from the City of Mentor met with Medilink earlier this year at Med-Tech Innovation Expo to discuss their partnership.
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