NORTH AMERIC AN EDITION
MEDICAL PLASTICS news WHERE
DO WE
GO FROM
HERE
+
THOUGHTS ON MEDICAL DEVICE TAX SHAPING MEDICAL DEVICES FIVE THINGS DEVELOPERS NEED TO KNOW
LUCIDEON ON POLYMER ANALYSIS AND COMPLEX CARDIOVASCULAR DEVICES, P.12 ISSUE 11
Jul/Aug/Sept 2019
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ADVANCING MEDICAL PLASTICS
Adding Value to Your Vision
• Diagnostics • Surgical • Dental Care
• Respiratory • Drug Delivery • Pharmaceutical
carclo
technical plastics
www.carclo-ctp.com 724-539-6989 sales@carclo-usa.com United States I United Kingdom I Czech Republic I India I China
CONTENTS MPN North America | Issue 11 | Jul/Aug/Sept 2019
WHERE
DO WE
GO FROM
HERE
Regulars
Features
3 Comment Laura Hughes provides her thoughts on medical device excise tax
9 Walking on sunshine MPN Editor Laura Hughes talks with iWalkFree president, Brad Hunter about the new plastic hands-free crutch
26 Five things developers need to know 3M discusses everything you need to know about skin before designing a wearable medical device
15 A new perspective SIMTEC Silicone Parts speaks about their new class 8 cleanroom
28 Shaping medical devices NuSil explains how medical device manufacturers can optimally utilize highconsistency rubber silicones
4 News focus 6 Digital spy 12 Cover story Lucideon discusses polymer analysis and complex cardiovascular devices 34 Back to the future
22 Thinking smart Representatives from Phillips-Medisize answer questions on smart manufacturing in the medical plastics industry
33 Medtec China: One of the global MedTechWorld series exhibitions More information on the 15th annual event which is taking place in September
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Learn more at www.dow.com/medicalsolutions
editor | laura hughes laura.hughes@rapidnews.com
EDITOR’S
group editor | dave gray
comment
head of content | lu rahman assistant editor | ian bolland advertising | sarah livingston sarah.livingston@rapidnews.com head of media sales plastics & life sciences | lisa montgomery head of studio & production | sam hamlyn graphic design | matt clarke junior designer | ellie gaskell publisher | duncan wood Medical Plastics News NA Print subscription - qualifying criteria US/Canada – Free UK & Europe – £249 ROW – £249 Medical Plastics News Europe Print subscription - qualifying criteria UK & Europe – Free US/Canada – £249 ROW – £249
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ISSN No: 2632 - 3818 (Print) 2632 - 3826 (Digital)
Thoughts on medical device excise tax
I
n June this year I headed out to New York - the city that never sleeps – to attend MD&M East, along with about 8000 advanced manufacturing professionals. The Medical Design Excellence Awards also took place during the event. These awards aim to recognize the technological achievements of medical device manufacturers. It was great to applaud companies’ innovations, and the benefits they bring to our family and friends. By the way, apologies if there are any typos in this piece. I am currently typing this with a broken hand (netball!) following a trip to A&E (or ER as it’s known over the pond) where I got to see some of these innovations in action – every cloud has a silver lining. While I was there, I had a long time to think in the waiting room, surrounded by medical tech. The prospect of the medical device excise tax going in to effect again in January 2020 is for me, and I’m sure many others, a concerning issue. This tax has the potential to affect the whole sector – from smaller start-ups to the big pharma giants. According to the US Department of Commerce, 28,834 jobs were lost within the medtech industry
from 2012 to 2015 when the tax was in place. The introduction of medical device excise tax could make business extremely difficult, particularly for smaller start-ups because of the way this tax works – being taxed on sales and not profit. The potential loss of jobs, and the effect of this on the growth of the sector could be hugely detrimental to the future of medtech. According to a statistic published in the European Medical Journal the number of medtech patent applications is not only greater than the biotech and pharma sectors, but also on the rise since the medical device excise tax was abolished in 2015.
“
“The prospect of the medical device excise tax going in to effect again in January 2020 is for me, and I’m sure many others, a concerning issue.”
AdvaMed is doing a great job of banging the drum for the sector, and hopefully it won’t fall on deaf ears. The association’s president, Scott Whittaker, believes that repealing the tax for good would be a shot in the arm for innovation – and I have to agree. Start-up and innovation awards will definitely help to encourage research in medtech, but will they be enough to keep the industry growing at the rate it currently is when the medical device excise tax is re-introduced? I’m not so convinced.
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NEWS FOCUS
A lower risk alternative to blood transfusions? MEDICAL DEVICES CLAIM TO BE ABLE TO ASSIST WITH CELL SALVAGE THERAPY BY COLLECTING THE BLOOD A PATIENT LOSES DURING SURGERY AND RETURNING IT TO THE PATIENT.
C
ell salvage therapy offers an alternative method to blood transfusions, where blood donated from another person is added to a patient’s body. During cell salvage therapy, blood shed from a patient is collected from the operating site and processed in a cell salvage machine with anticoagulant medication to prevent clotting. The blood is then given back to the patient. This method is also referred to as autologous transfusion. Unlike with blood transfusions, factors such as blood type do not have to be considered prior to cell salvage therapy. However, there are circumstances when autologous transfusions wouldn’t be suitable including in the case of serious injuries, or if a patient had already lost a lot of blood before the surgical procedure. Additionally, not all operations will result in enough blood loss to make cell salvage worthwhile. Ecomed Solutions’ HEMAsavR is one of the devices aiming to assist with cell salvage therapy. The device works by collecting any blood a patient loses during surgery and returning it to their body. HEMAsavR claims to be able to help eliminate many of the risks associated with allogeneic blood transfusions - for example, the device avoids the chance of infectious diseases being present in donor blood, as although blood banks do screen donated blood, there is still a risk, albeit a small one that infectious diseases could be present in donor blood.
HEMAsavR offers advantageous features such as a closed system with a sterile collection and transfer device which means specialized resources should not be necessary for the collection of blood, and the hard shell canister of the device is reusable. Additionally, the device also claims to be compatible with surgical suction and autotransfusion systems and is therefore designed to be installed in operating theatres. Comprehensive Blood Management CEO Gary Koenig said: “Allogeneic blood transfusions have long been an integral and necessary part of healthcare delivery throughout the world, but with HEMAsavR we can decrease the exposure to and risks of transfusion and achieve better patient outcomes while decreasing associated costs. Having HEMAsavR in the operating room is a win-win proposition for the patient and hospital.”
Unlike with blood transfusions, factors such as blood type do not have to be considered prior to cell salvage therapy. 4
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DIGITAL
spy
SMALLER, PORTABLE DIALYSIS MACHINE COULD HELP RENAL DISEASE SUFFERERS
TECHNOLOGY UPDATE
www.childrenshospital.org
Technology focused training
N
eurological teaching robots have been implemented in to Boston Children’s Hospital to help train medical staff on procedures. The medical robots are created with 3D printed materials and different types of silicone, and were developed for procedures including abdominal surgery, scalp
TECHNOLOGY UPDATE
lacerations and gunshot wounds. Greg Loan, senior simulation engineer at Boston Children's Hospital commented: “You have simulators that appear human, that feel human, bleed and do all of the right things that you can actually do surgery on but underneath they're robotic.”
A
briefcase-sized portable dialysis system has been developed by Japanese researchers from the University of Yamanashi, Kobe University, Kawasaki University of Medical Welfare and Kitasato University.
Sales of this device are expected to begin in 2023 once clinical tests are completed.
The device is reportedly much smaller than a conventional portable dialysis machine, and claims to be 30 cm tall, 18 cm wide and 12 cm deep, with a weight of 3 to 4 kg. The small size is enabled through its hemofilter which is one-eighth the size of its standard equivalent, and its blood drawing pump which is the same size as an American dollar coin. Research which has been conducted has shown that the machine can filter goats’ blood for up to two weeks without the need to change the device pump. The device is designed for use by renal disease sufferers, either
PROF. KENICHI MATSUDA OF THE UNIVERSITY OF YAMANASHI ©
REGULATORY UPDATE www.hpm.com
Three key questions Analysis finds premarket approvals are on the rise
L
awyers from Hyman Phelps & McNamara claim in a Food and Drug Law Institute blog post that the Food and Drug Administration (FDA) are more likely to approve applications for premarket approvals (PMAs) following the revisions made in the panel meeting process in 2010. In 2010 the FDA introduced anonymous voting on three separate questions about the safety, effectiveness and benefit-to-risk ratio of devices. Before this, experts on the panel were simply asked if they recommended approval of the device. To assess the impact of the process changes on approval rates, researchers looked at 37 panel meetings under the old system and 52 under the
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to provide rapid assistance in the case of emergencies, or in remote locations for the patient.
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new system. The analysis found that in the five years before the changes were implemented the FDA reportedly approved 70% of PMAs which were sent for review by an expert panel. Following the process revisions, the approval rate is said to be 92%. The analysis also found that device effectiveness is not correlated to approval rates.
DIGITAL SPY
REGULATORY UPDATE
talking
POINT WWW.BELLASENO.COM
FULLY CERTIFIED BELLASENO, A COMPANY WHO DEVELOP ABSORBABLE IMPLANTS USING ADDITIVE MANUFACTURING TECHNOLOGY HAVE OBTAINED FULL ISO 13485 CERTIFICATION FOR ITS DESIGN AND ADDITIVE MANUFACTURING PROCESSES.
T
his certification covers the concept and prototype to the production of novel, non-silicone-based absorbable implants. Simon Champ, CEO of BellaSeno commented: “We are now one of very few companies worldwide with an ISO 13485 certification covering the
entire process of design and additive manufacturing of absorbable implants.” Absorbable implants encourage the growth of natural tissue from the patient’s own body. Over time absorbable implants are fully absorbed and accepted by the body. This means that unlike many other implants, there is no foreign body remnants.
www.innaccel.com
Device provides breathing support for babies HOSPITAL IN MAHARASHTRA, INDIA HAS BECOME ONE OF THE FIRST HOSPITALS TO ADOPT AN INNOVATION DESIGNED TO SUPPORT A BABY’S BREATHING DURING TRANSPORTATION. get breathing support, and there is currently no device to help babies breathe during transport to the NICUs. The device, Saans claims to be able to give continuous positive airway pressure, either through manual air pumping, direct electricity or the device’s
HOW TO GET MEDICAL DEVICE RECALL INFORMATION FASTER HEALTH CARE TECHNOLOGY COMPANY SOOM ANNOUNCES THE LAUNCH OF A MOBILE APPLICATION NAMED, SOOMSAFETY. WHAT IS SOOMSAFETY? SoomSafety is a mobile app that is able to provide medical device recall information to patients, nurses and caregivers directly from both the device manufacturer and the FDA.
DEVICE UPDATE
Siraj Dhanani, a developer of the device comments: “More than half the babies who need this (breathing support) are born outside patient care at maternity homes, at primary health centres and maybe at home.” These babies therefore require transport to the nenonatal intensive care units (NICUs) to
www.SOOM.com
rechargeable battery. Prince Harry recently acknowledged the device with an award for its potential impact to advance one of the United Nation’s sustainable development goals in Commonwealth countries. The company is seeking European and US regulatory approvals.
HOW DOES THE APP WORK? The app uses openFDA - an open-source database that enables developers to use FDA data in applications. Users are able to scan the barcode of a medical device or the barcode on a patient’s medical device identification card, in order to identify a device and store the device on the app. WHAT INFORMATION DOES THE APP SHOW? For all devices stored on the app, any recall information as well as safety and use information for each device is displayed. WHAT HAPPENS IF A DEVICE IS RECALLED? The app will notify users of this recall and provide the next steps the user must take. WHY IS THERE A NEED FOR THIS APP? In 2019 there was reportedly 26 medical device recalls which affected nearly 50 million individual devices in the United States. As a result of incomplete information in the medical device supply chain, some patients may never have even been informed of the recall. DOES AN APPLICATION LIKE THIS EXIST ON THE MARKET ALREADY? Soom claim that this is the first mobile application to close the information gap between the FDA, the manufacturers and medical device users.
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40 years. Thanks to their excellent properties, our high-performance acrylics are perfect for use in a wide range of medical devices. CYROLITE is highly transparent and easily processed into intricate parts. It can be reliably sterilized using most common methods and is free from hormone-related substances and plasticizers. This has impressed both patients and health-care professionals alike: CYROLITE meets the requirements of USP Class VI, ISO 10993-1, and REACH. You can find more details at www.cyrolite.com.
INNOVATIONS
A NEW PLASTIC 'HANDS-FREE CRUTCH' IS GIVING A FRESH LEASE OF LIFE TO AMPUTEES IN THE UNITED STATES. LAURA HUGHES, EDITOR OF MEDICAL PLASTICS NEWS, CAUGHT UP WITH IWALKFREE PRESIDENT, BRAD HUNTER TO LEARN ABOUT THE BACKGROUND OF THE PROJECT.
Walking on Sunshine
I
t wasn’t until Hunter suffered a bad ankle sprain that he realized how truly limiting crutches could be. He explained that, although the injury had made him lose the use of his leg, the crutches made him lose the use of his hands and arms. Simple tasks like cooking food, folding laundry, or even navigating through a spring loaded door were in Hunter’s words, “nearly impossible” on crutches. Then, as if using the crutches wasn’t enough of a hindrance, the side effects such as pain in the hands, wrists and armpits only served to compound the issue. On a quest to find a better alternative to crutches, Hunter went on the lookout for an orthopedic boot. He found one on private party sales site, Craigslist, and decided to take the plunge. He tells me that when he arrived to collect the boot however, he noticed that the seller also had a first generation iWALKFree crutch. Hunter remembers how he thought that the iWALKFree device was a “game changer” and found himself wondering why this device wasn’t the go-to device for lower leg injuries. He describes how he knew he wasn’t alone in this belief as, “whenever I went out in public, I would be approached by random strangers who wanted to know all about the iWALK and share how much they hated crutches when they had their injury.” Intrigued and impressed by this device, Hunter conducted some research in to the company and found out that it was essentially a one man operation, being run by a Canadian farmer who founded the company. He explains: “Essentially, they had a highly disruptive
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Going further with Experience. Passion. Innovation. ENGEL stands for “Experience. Passion. Innovation.” It is not only at the K show that we have put that claim to the test – it is something we do every single day, with our experience laying the foundation for revolutionary ideas. Drawing on our passion for injection molding machine manufacturing, we work to engineer pioneering solutions to make our customers’ production processes even smarter, more sustainable and more successful. See ENGEL’s impressive range of products for yourself at K: hall 15, stand C58
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INNOVATIONS
technology begging for more development. While the first generation iWALK was good, it needed to evolve in order to become commercially viable.” Today, Hunter runs the company and is the single largest shareholder. From the outset, the iWALK2.0 was designed so that manufacture was scalable. Hunter commented how, “for the major structural plastic parts, we started by selecting common, readily available materials, determining the material properties, and designing the parts around these properties.” The reason for this was to ensure that the manufacture of the device wasn’t dependent on either a specially compounded material or the expertise of any one molder. In terms of the frame, it is made of tubular aluminium extrusions. Hunter mentioned how this was, “patterned after crutches and canes, since manufacture of these items was completely mature, and many suppliers are capable of producing the tubing we use.” All of the manufacturing culminates in an ISO13485 rated facility in California near Hunter’s office. This means that if a field call is required, Hunter and his colleagues can be on site in 15 minutes. Simplicity is one of the huge advantages of the iWALK2.0 device. In order to achieve this, there was lots of research conducted during the development of this device. Many factors were considered by Hunter during the development process, such as: • Human factor - the iWALK2.0 fits 95% of the adult population, and human proportions vary greatly • Gait adaptation - motion capture technology was used to compare human gait to iWALK gait in order to keep the amount of gait adaptation to a minimum • Leg geometry – adjustments were made to allow the device to be tailored • Adjustable - a simple device the end user can adjust themselves • Convertible - the ability to make the device easily transferable from the left to right leg • The assembly of the device • Packaging
– an accomplishment never achieved before. The following year iWALK2.0 again took home all of the awards from the trade show. The company believe these rewards are a sign of recognition from the medical community for the innovative, functional and affordable iWALKFree2.0.
"
Whenever I went out in public, I would be approached by random strangers who wanted to know all about the iWALK and share how much they hated crutches when they had their injury.
In terms of selecting the best material for this device, Hunter explains how for molded parts they worked with the molders to analyze the specific requirements of each part, to determine the best choice of material. The part was then designed to work harmoniously with the properties of the chosen material. Plastic was chosen for certain parts of the device as it provided the best combination of weight, strength, stiffness, ergonomic shapes, and cost according to Hunter. Hunter describes how, “not unlike most devices” factors such as consumer safety, utility, comfort, ease of use, commercial viability, scalability of manufacture, packaging and storage all had to be considered when designing the device. However, there was surprisingly few challenges experienced when developing iWALK2.0. Hunter puts this down to his copious previous experience in manufacturing. Hunter comments, “you develop a nose for potential problems, and we identified those and addressed them in the design phase.” Additionally, Hunter highlights their choice of quality manufacturing partners as another reason for so little challenges being experienced with the development of the device. iWALK2.0 debuted at the medical device show Medtrade in North America. At the event the device took home all of the awards
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COVER STORY
IN THIS PIECE LUCIDEON’S POLYMER TECHNOLOGY CONSULTANT, RICHARD PADBURY, LOOKS AT SOME OF THE CHALLENGES IN POLYMER ANALYSIS AND HOW MANUFACTURING CHANGES THE COMPLEXITY OF CARDIOVASCULAR DEVICES IN THE POLYMER MARKET.
WHERE
DO WE
GO FROM
HERE WHAT IS CORONARY ARTERY DISEASE (CAD)? CAD is a significant contributor to cardiovascular disease (CVD), which resulted in an estimated 17.9 million deaths in 20161. CAD is caused by a build-up of fatty deposits on the artery walls, causing inadequate supply of oxygen rich blood to the heart which increases the risk of heart attack. The standard treatment for CAD is a non-surgical percutaneous coronary intervention (PCI) that uses a collapsed polymer balloon guided by a thin wire into the narrowed section of the artery. Subsequently, the balloon is inflated to force the artery open and restore blood flow to the heart. The artery may also be supported by a cardiovascular implant known as a stent.
COVER STORY STENT TECHNOLOGY The main generations of stent technology include bare metal stents (BMS) and drug-eluting stents (DES), which are primarily composed of metallic substrates, and bioabsorbable stents (BAS) synthesized from bioresorbable polymers. A significant drawback of BMS is that the materials are typically incompatible with the vascular environment, which leads to an increased risk of restenosis. These drawbacks are overcome by DES through the release of antiproliferation drugs from absorbable or non-absorbable biopolymer coatings. As an alternative, BAS were designed to reduce the long-term complications associated with BMS, as their degradation byproducts are eliminated by the body during resorption, as the artery naturally heals. However, market adoption of BAS has been slower than anticipated due to concerns with lower radial strength, stent recoil, stent deployment and higher costs. From a materials perspective, a lot can be learned from these products and the inherent properties of different materials developed for medical devices. POLYMERS Polymers are characteristically different from metals because of their viscoelastic behavior. This leads to distinct time dependencies, melting points and thermal transitions which determine whether the polymer acts like a flexible, rubbery material or a brittle glass. These characteristics can be subtly modified by changing a few molecules or blending and copolymerizing with other polymers. However, it is important to note that when we improve one aspect of a polymer it can be at the cost of another, either in terms of mechanical performance, degradation time or biocompatibility. Polymers also have vastly different microstructures compared to metals, and across different polymer chemistries, which range from purely amorphous to semi-crystalline. A team of researchers at Massachusetts Institute of Technology (MIT) used Raman spectroscopy to analyze the microstructures of BAS. Their study showed that discrete variations in polymer chain orientation and crystallinity can form from the stent surface to the stent core. They attributed these fluctuations to thermal and mechanical strains that occur at each manufacturing step and after deployment. Ultimately, this can lead to non-uniform degradation and a decrease in structural integrity which could promote larger deformations that block or disrupt blood flow. This work has important implications for strut thickness, a critical design feature of BAS. The thickness of the struts is directly tied to the mechanical properties of the polymer. If the mechanical properties of the polymer are insufficient then thicker struts are required, but this increases the risk of turbulent blood flow and thrombosis. With a greater understanding of microstructure, it may be possible to modify processes to enhance molecular orientation, eliminate microstructural irregularities and increase the materialâ&#x20AC;&#x2122;s stiffness. Subsequently, this could promote the development of thinner BAS (<100Âľm), using the same materials, with performance characteristics comparable to BMS and DES. Most medical devices, from guidewires and catheters to balloons and stents, go through numerous process steps during high-throughput manufacturing. Every manufacturing step has its own unique set of process conditions which increases the chance of picking up contamination, defects and changes in morphology and microstructure. When failures do occur, the root cause can be confounded by the multiple process steps, and corrective actions become more difficult to prescribe. Nevertheless, there are numerous thermal, mechanical and chemical methods validated for medical devices and, as demonstrated by the MIT study, it is important to acknowledge that material structures and failure modes vary across different material types and that the resolution of the analytical instrument is an important consideration when characterizing device quality. In short, stents are a good lesson in polymer process-structure-properties and design for medical devices. All factors must come together to deliver a breakthrough performance. SO, WHAT DOES THE FUTURE HOLD FOR THE CARDIOVASCULAR MARKET? BAS technology should not be discounted all together; there is still an
emphasis on improving longterm patient outcomes, which can certainly be achieved if these products can be refined and made safer. However, the use of conventional DES will likely continue, and studies are now showing comparable performance between DES and drug coated balloons. Major innovations could come from coatings and the type of pharmaceutical actives used.2 Advancements in coatings, bulk additives or surface modifications with varied surface charge, topography, and antibacterial and anti-thrombogenic properties may become important advances for guidewires, catheters and a wide range of cardiovascular devices. A particular focus area at Lucideon is the development of drug free antibacterial materials, with the aim of overcoming challenges associated with antibiotic resistant infection. Based on what we have observed at Lucideon, we anticipate that regulatory evaluations will become ever more stringent. Examples include demonstrating coating durability, thickness, uniformity and coverage to new levels - along with the safety, stability, dose and release rate of actives. Additional requirements include particulate evaluations during deployment and withdrawal simulations and following radial fatigue testing. Obtaining the data to support these requirements often needs new methods and techniques, and indeed this is something we are being increasingly tasked with by manufacturers. No matter which direction you turn, it is essential to understand the differences between materials and the various analytical capabilities available to characterize device structure, properties and design.
REFERENCES
1 https://www.who.int/en/news-room/ fact-sheets/detail/cardiovasculardiseases-(cvds) 2F rost & Sullivan. (2016, March 30). Next Generation Stent Technologies. Overtaking Traditionally Dominant Bare-Metal Stents (BMS), Drugeluting (DES) and Bioabsorbable Stents Race Ahead. 3 http://news.mit.edu/2018/studyreveals-why-polymer-stentsfailed-0226 4 https://doi.org/10.1016/S01406736(18)31719-7
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CLEANROOMS
MPN EDITOR LAURA HUGHES MET WITH FRANK DILLY, MANAGING DIRECTOR, AND CALVIN PENDORF, HEAD OF ENGINEERING, BOTH FROM SIMTEC SILICONE PARTS TO TALK ABOUT THE RECENT ADDITION OF THEIR NEW CLASS 8 CLEANROOM.
A new perspective S
IMTEC class themselves as early pioneers in the liquid silicone rubber (LSR) injection molding industry, following their establishment in 2001 in Madison, Wisconsin.
They specialize in high volume, and highly automated LSR injection molding, LSR over-molding, LSR two-shot and multi-shot molding, and also now hygienic class 8 cleanroom production. The company also offer made-to-order solutions for customers within the life science, automotive, consumer, sanitary and building-technology industries. In 2013, SIMTEC moved location to South Florida, whilst maintaining many of their core technical team in the process. The company went on to join European based Rico Group, an established group of highly qualified LSR solutions providers in 2016. Simtec believe this partnership with the Rico Group has led to many advantages for the company including the strengthening of their resources and the expansion of their global footprint. SIMTEC CLAIM THAT ONE OF ITS KEY DISTINGUISHING FACTORS IS ITS TRUE TWO-SHOT MOLDING TECHNOLOGY. WHAT DO YOU MEAN BY THE TERM ‘TRUE TWO-SHOT’? Two-shot molding has previously been used to refer to processes in which the two components are molded in different machines. However, we believe
it is critical to mold both the plastic and silicone in one machine with two injection units. In true two-shot molding, two substrates (such as LSR and thermoplastic or LSR and LSR) are molded in the same machine at the same time. The result is an integrated, multi-substrate, multifunctional component with a strong bond. We believe that the advantages of true two-shot molding for customers include: • Eliminating the need, costs and time associated with secondary steps (such as assembly) • Material savings (sealing surface only – no material waste) • Secure placement • Components with complex part geometries
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freudenbergmedical.com/simplify Catheters • Extrusion • Molding • Assembly • Coating
CLEANROOMS
WELL-KNOWN AS A LSR INJECTION MOLDING SPECIALIST, WHY DID SIMTEC DECIDE TO INVEST IN A CLEANROOM? There were two main reasons for this investment - the first being that SIMTEC had already held the ISO 13484 certification for years, therefore taking the necessary steps to meet ISO certified cleanroom standards felt like an attainable logical next step. Additionally, we already had a conducive environment and culture, and our facility is new and exceptionally clean. Our production is also highly automated with very minimal human touch or interference. The second reason for the cleanroom investment was in response to the demand from our life science customers. Dilly was previously quoted saying: “Medical device OEMs like our highly automated technology and requested we add a cleanroom to our production.” HOW DID YOU ACHIEVE THE CLEANROOM YOU HAVE TODAY? Our first step was to talk to our customers to determine the hygienic requirements needed for the present and foreseeable future. We next explored the ISO classifications applicable and the requirements. To establish a benchmark from which to devise our own plan, we visited experienced cleanroom operators and builders in the United States and Europe, and our sister company, Silcoplast in Switzerland - an experienced, high quality cleanroom molder. We believe that LSR is more clean than other elastomers and thermoplastics. As LSR is a liquid, it is received and hydraulically pumped into molding machines from containers called drum kits. This means that no dust is generated, unlike many other materials where this dust occurs. We also believe our tooling technology is advantageous as we are always aiming for direct gating whenever possible and thus, excluding secondary steps (e.g. de-flashing, die-cutting or cleaning). “Once we established our requirements, we chose a supplier and put together a plan to build a class 8 cleanroom on our existing production floor with a unique hybrid design, and a plan that would facilitate quick expansion as needed”, noted Calvin Pendorf, who spearheaded the cleanroom project. YOUR CLEANROOM HAS BEEN DESCRIBED AS A ‘SMART DESIGN’ WHY IS THAT? Our cleanroom has a somewhat unique layout. Typically, in most cleanrooms all equipment and activities are contained within the cleanroom; our layout is different. We wanted to minimize contaminants Maximum Number of Particles in Air (Particles per cubic meter) ISO Class
Fed-Std 209E Class
ISO 1 ISO 2
Particle Size ≥0.1μm
≥0.2μm
10
2
≥0.3μm
≥0.5μm
≥1μm
≥5μm
100
24
10
4
ISO 3
(Class 1)
1,000
237
102
35
8
ISO 4
(Class 10)
10,000
2,370
1,020
352
83
ISO 5
(Class 100)
100,000
23,700
10,200
3,520
832
ISO 6
(Class 1,000)
1,000,000
237,000
102,000
35,200
8,320
293
ISO 7
(Class 10,000)
352,000
83,200
2,930
ISO 8
(Class 100,000)
3,520,000
832,000
29,300
MAXIMUM NUMBER OF PARTICLES IN AIR BY ISO CLASS OF CLEANROOM
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RECOMMENDED AIR CHANGES AND CEILING COVERAGE BY ISO CLASS OF CLEANROOM. SOURCE: CLEANAIRPRODUCTS.COM
Recommended Air Changes and Ceiling Coverage ISO Class
Air Changes Per Hour
Ceiling Coverage
ISO 1
500-750
80-100%
ISO 2
500-750
80-100%
ISO 3
500-750
60-100%
ISO 4
400-750
50-90%
ISO 5
240-600
35-70%
ISO 6
150-240
25-40%
ISO 7
60-150
15-25%
ISO 8
5-60
5-15%
as much as possible, by reducing traffic in and out of the cleanroom and eliminating as many of the sources of particles as we could. In our cleanroom layout, material staging takes place outside the cleanroom. Tool setups and changes take place in a separate enclosure attached to the cleanroom with a pass-through. The rest of the molding machine remains outside the cleanroom. Parts produced in our fullyautomated one-shot and two-shot lines are robotically removed and transported within a filtered and pressure-controlled enclosure into the cleanroom for inspection, postcuring and bagging. HAVE YOU EXPERIENCED ANY GROWTH OPPORTUNITIES AS A RESULT OF YOUR EXPANDED CAPABILITIES? Yes, we are confident we are competitive in terms of our technology level, accuracy and performance in this space. As a result, we have been fortunate enough already to have increased opportunities with many well-known medical device manufacturers in the United States. Pendorf will be a speaker at the upcoming 2019 LSR conference in Schaumburg, United States on 9th to 12th September. Here, Pendorf will discuss the best way to set up a cleanroom.
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MICROFLUIDICS
coupled waters RESEARCHERS AT DOE’S LAWRENCE BERKELEY NATIONAL LABORATORY (BERKELEY LAB) HAVE 3D PRINTED AN ALL-LIQUID DEVICE THAT CAN BE REPEATEDLY RECONFIGURED ON DEMAND TO SERVE A WIDE RANGE OF APPLICATIONS.
L
ast year, a study co-authored by Brett Helms, a staff scientist in Berkeley Lab’s materials sciences division and molecular foundry, and Thomas Russell, a visiting researcher from the University of Massachusetts, pioneered a new technique for printing various liquid structures – from droplets to swirling threads of liquid – within another liquid. “After that successful demonstration, a bunch of us got together to brainstorm on how we could use liquid printing to fabricate a functioning device,” said Helms. “Then it occurred to us: If we can print liquids in defined channels and flow contents through them without destroying them, then we could make useful fluidic devices for a wide range of applications, from new types of miniaturized chemical laboratories to even batteries and electronic devices.” To make the 3D-printable fluidic device, lead author Wenqian Feng, a postdoctoral researcher in Berkeley Lab’s materials sciences division, designed a specially patterned glass substrate. When two liquids – one containing nanoscale clay particles, another containing polymer particles – are printed onto the substrate, they come together at the interface of the two liquids and within milliseconds form a very thin channel or tube about 1mm in diameter. Once the channels are formed, catalysts can be placed in different channels of the device. The user can then 3D-print bridges between channels, connecting them so that a chemical flowing through them encounters catalysts in a specific order, setting off a cascade of chemical reactions to make specific chemical compounds. And when controlled by a computer, this complex process can be automated “to execute tasks associated with catalyst placement, build liquid bridges within the device, and run reaction sequences needed to make molecules,” said Russell.
BERKELEY LABORATORY ©
The multitasking device can also be programmed to function like an artificial circulatory system that separates molecules flowing through the channel and automatically removes unwanted by-products while it continues to print a sequence of bridges to specific catalysts and carry out the steps of chemical synthesis. “The form and functions of these devices are only limited by the imagination of the researcher,” explained Helms. “Autonomous synthesis is an emerging area of interest in the chemistry and materials communities, and our technique for 3D printing devices for all-liquid flow chemistry could help to play an important role in establishing the field.” Russell added: “The combination of materials science and chemistry expertise at Berkeley Lab, along with world-class user facilities available to researchers from all over the world, and the young talent that is drawn to the Lab is unique. We couldn’t have developed this program anywhere else.” The researchers next plan is to electrify the walls of the device using conductive nanoparticles to expand the types of reactions that can be explored. “With our technique, we think it should also be possible to create all-liquid circuitry, fuel cells, and even batteries,” said Helms. “It’s been really exciting for our team to combine fluidics and flow chemistry in a way that is both user-friendly and user-programmable.”
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MICROFLUIDICS
NEW SURFACTANTS HIT THE MARKET, PLUS REDBUD LAUNCHES CHIP LINE FOR RAPID MIXING.
D
olomite Microfluidics has announced a new partnership with Emulseo – a start-up company producing surfactants for droplet-based microfluidics – to distribute FluoSurf, a high-performance continuous phase surfactant specifically formulated to stabilize aqueous droplets in microfluidic systems. FluoSurf is compatible with a wide selection of reagents in the droplet phase that would disrupt the stability of emulsions formed with traditional stabilizers, and is ideal for applications in fields such as droplet formation and microencapsulation, according to the two firms. This copolymer comprises ambiphilic polymer blocks that allow stabilization of the interface between aqueous droplets and fluorinated oils. Dolomite says it offers fast droplet formation rates and enables the creation of highly stable emulsions of a broad range of monodisperse droplet sizes that can be readily broken when desired. Quentin Jochyms, CTO and co-founder of Emulseo, said: “FluoSurf was developed and optimized specifically for droplet-based microfluidics applications, and will meet the demand for a biocompatible surfactant that provides batch-to-batch reproducibility.” Richard Gray, vice president of particle engineering and microfluidics at Dolomite Microfluidics, added: “We chose Emulseo as our partner to offer FluoSurf to our customers worldwide. We are delighted to be distributing this product, which will greatly improve the market for emulsion stabilizers, and look forward to a fruitful collaboration with Emulseo.” Meanwhile US-based Redbud has announced an expansion to its MXR (“mixer”) microfluidic chip family with the introduction of MXR Blue. The MXR Blue line of chips is a new formulation of the company's proprietary Redbud Post technology designed to maintain performance in sample-to-answer cartridges without the need for additives.
but were restricted in their ability to utilize surfactants in their assays. Thanks to MXR Blue hydrophilic characteristics this is no longer an issue. Developers can integrate the cartridge-ready chip into their protocols and immediately reap the rewards of MXR-enhanced mixing. With MXR Blue, it's now possible to work directly with non-diluted biological fluids like whole blood, urine, cerebral spinal fluid, saliva, synovial fluid, plasma, serum, etcetera.” Redbud’s MXR chips are recognized for their rapid mixing capability in microfluidic volumes where reliance upon diffusion kinetics limits the performance of sampleto-answer assays. MXR chip models are assembled microfluidic components, well-suited for use with microarrays, reagent reconstitution and microfluidic cartridges. MXR Blue comes in two standard chip assemblies.
MXR Blue is designed for use in a range of applications, especially for system developers seeking to improve diagnostic sensitivity, shorten timeto-result, or simplify the consumable for a multiplexed genomic or proteomic test. With MXR Blue, assay developers can now flood chambers directly with raw biofluids such as blood or urine, cell media, pure water, and other highsurface tension fluids. “We developed MXR Blue based on customer demand,” said Jay Fisher, vice president of research and development. “Researchers and systems developers alike have been seeking out the mixing advantages of MXR,
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INNOVATION SMART MANUFACTURING IN IMPLANTS AND AUTOMATION
THINKING SMART KEVIN DEANE, VICE-PRESIDENT, INNOVATION, PHILLIPS-MEDISIZE AND DAVID WOLGEMUTH, MOLDING AND MANUFACTURING TECHNOLOGY SPECIALIST, PHILLIPS-MEDISIZE DISCUSS SMART MANUFACTURING IN THE MEDICAL PLASTICS INDUSTRY.
1. THERE IS A HUGE EMPHASIS ON BRINGING A DEVICE TO MARKET AS QUICKLY AS POSSIBLE. IN ORDER TO ACHIEVE THIS, WHAT CHANGES DO YOU THINK SHOULD BE IMPLEMENTED IN TO THE MANUFACTURING PROCESS? We have focused on developing an integrated core platform that combines plastic components, electronic components, sensor technologies and associated software at Phillips-Medisize. Basing development of connected medical devices on these platform technologies provides the opportunity to use proven designs and established, repeatable manufacturing processes. This often enables manufacturers to utilize existing infrastructure and facilities to continuously produce the core product across multiple customers. At the same time, it provides an opportunity to customize design features as needed to meet unique customer applications. 2. HOW DO YOU BELIEVE PRODUCTION TIMELINES CAN BE OPTIMIZED? The key to production timeline optimization is allowing sufficient time upfront to review and revise designs before beginning any production line preparation. Otherwise, process qualification for parts, assemblies and automation may delay production launch. Therefore, working with a knowledgeable and responsible manufacturing design partner is critical. It is also vital to involve the supplier early in the design process and to implement the feedback provided, since it may require re-design or re-testing of the verified design.
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Cranioplasty can be defined as the surgical repair of a defect or deformity of the skull. The function of the cranium, the top part of the skull is to house and protect the brain, and this role is of high importance due to the brain controlling many processes such as thoughts, movement, memory and speech.
Cranial implants may be needed to reconstruct the skull of a patient that has experienced incidents such as head trauma or a neurovascular accident. It is particularly important for these implants to be strong and malleable. The innovation of custom made implants has been made possible through advances in medical imaging such as Magnetic Resonance Imaging (MRI) and Computed Tomography (CT) which allow the 3D reconstruction of structures. It is believed that the use of 3D reconstruction techniques from medical images could reduce the possibility of errors during surgery, offer an improved fit and provide better implant stability. The surgical time is also reported to be significantly shorter for personalized implants compared to standard commercial implants. This is thought to be due to achieving a good fit for the implant first time. Granta, a small start-up in Mexico City, are using its industrial-design background to create these custom implants.
Carlos Monroy, CEO, Granta highlighted how the company was in its infancy: “We’re starting by creating this skull implant. It is a patient-specific implant to fix and reconstruct the skull of a patient that has been suffering from a head trauma, neurovascular accident, a tumor or from being born with deformation.” D LI C LA S NS E. C WOS M . C O MDiscussing a case where Granta W W W .W MW E D. M I CE A P LAAL SP T I CS STNI CE W
SMART MANUFACTURING AND AUTOMATION
To meet this need, PhillipsMedisize has been instituting a set of strategic initiatives which includes hiring electronics experts, acquiring Medicom Innovation Partner for its expertise in integrated and vertical medical devices, and being acquired by Molex to provide electronic components and innovative electronic development on a global scale.
3. W HAT ARE THE MOST EFFICIENT WAYS TO TACKLE THE INITIAL DESIGN AND CONCEPTING PHASE BETWEEN MANUFACTURERS AND PARTNERS? Our goal is to pull together a combination of stakeholders, including design, marketing, finance, procurement and manufacturing, in the earliest stages of connected medical device development. This approach allows us not only to work with front-end innovators to define the concepts that deliver the best features and usability for patients, caregivers and healthcare professionals, but also to identify the manufacturing and commercial realities that will contribute to the product’s success in the marketplace. The device manufacturers’ needs are built more around business requirements, so it’s vital to strike a balance between design features and the cost of goods, length of use, production time and manufacturing complexity. Ultimately, the product must be developed at a cost point, scale and level of reliability that will generate return on investment. 4. WHAT ARE THE MAIN CHALLENGES ASSOCIATED WITH THE SMART MANUFACTURING OF PLASTICS? The challenge is that most parts are designed first for the mechanical application, and the molding design is added afterwards. Although this is understandable, it is important to integrate molding requirements early in the process in order to address shrink, sink and a host of other factors caused by heating, forming and cooling thermoplastics. These changes may affect the mechanical design, requiring adjusting the overall device design to avoid molding parts with unmanageable tolerances and quality issues. 5. HOW CAN THESE CHALLENGES BE OVERCOME? Design is crucial to the smart manufacturing of thermoplastic parts. The first priority is geometry that provides part gating, filling, ejection and removal from the mold with ease. Suppliers understand the injection molding process and most thermoplastic materials extremely well, and while many new injection molding machines offer added features and control aspects, even older machines are typically consistent and repeatable. The value of involving the manufacturer upfront in the design process, even as early as conceptual drawings, cannot be emphasized enough. Designing mechanical assembly, electronic integration and full device function while including all relevant molding, assembly and automation production requirements is not a sales pitch to lock in a supplier early. It is a smart strategy that can accelerate the production timeline, support compliance and even provide unexpected solutions that deliver a competitive edge. 6. DO YOU THINK THAT CONNECTED HEALTH PLAYS AN IMPORTANT ROLE DURING PLASTICS MANUFACTURING? Embedded electronics and connectivity are emerging trends in medical devices. Therefore, it’s important for companies to understand how to merge the somewhat disparate industries of high-volume, low-cost plastics manufacturing with high-volume electronics manufacturing in order to design and produce integrated systems that work for patients and healthcare professionals.
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7. HOW DO YOU BELIEVE CONNECTED HEALTH COULD ENABLE MANUFACTURERS TO ACCELERATE THE PRODUCTION PROCESS OF PLASTIC COMPONENTS? Adding connectivity to medical devices often makes them viable as reusable devices and moving away from the disposable market into the reusable one offers advantages for plastics manufacturers. Reusable devices reduce the overall volume of parts that need to be produced, in turn reducing the complexity of the plastic molding manufacturing operation and accelerating time to market. 8. WHAT CAN BE DONE TO ENSURE TIGHTER COMPLIANCE WITH FDA REGULATIONS DURING THE MANUFACTURING OF PLASTICS? Meeting established plastics design standards, tolerance expectations and tooling design increases the overall device design effectiveness, which reduces variability and tightens compliance. Device function and electronics integration must be built on properly designed mechanical features, which are shaped during the plastic molding process. The filling, cooling and any associated warp from the molding process affect the final geometry and dimensions of these critical function features.
Working with a knowledgeable and responsible manufacturing design partner is critical. WWW.MEDICALPLASTICSNEWS.COM
To ensure consistent molded plastic results, Phillips-Medisize emphasizes proper design review, processing knowledge and preparation. The right initial design is essential to accurately and efficiently completing all downstream activities that qualify or validate the process.
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SMART MANUFACTURING AND AUTOMATION
MORETTO MARKETING DEPARTMENT HIGHLIGHTS THE IMPORTANCE OF THE SMART DEHUMIDIFICATION OF RESINS AND DISCUSSES TWO CASE STUDIES.
Keeping dry T
he production of medical products presents multiple challenges to manufacturers, especially injection molders or extruders of plastic medical products. A common headache is the pre-conditioning of hygroscopic resins for processing. Hygroscopic resins are characterized as capable of absorbing moisture into their chemical structure that adversely affects the product’s performance once molded or extruded. To meet product performance standards, that moisture must be removed prior to processing. The process of moisture removal in resins faces two unique challenges for medical product manufacturers: 1. The inability to physically see or confirm resin changes that verify successful moisture removal 2. The commonly low throughputs and frequent changes of medical plastic production that often preclude the use of high volume, sophisticated systems designed for large scale dehumidification Producers of medical products processed from engineering-grade thermoplastic resins face the need to dehumidify reliably, but at lower rates. It is common for medical processors to seek preconditioning equipment that will fit onto the processing machine throat. In attempt to tackle these multiple problems, a compact drying system called X Comb has been developed by Moretto which is mounted on the machine that incorporates the precision necessary to meet these medical requirements. This drying system incorporates a compact drying hopper that mounts directly to the throat of an injection molding machines or extruder
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and is directly coupled to a self-regenerating dehumidification system that employs a rotating desiccant wheel. The wheel contains exclusive zeolite desiccant that is formed into an enclosed honeycomb wheel, providing minimal air flow resistance yet incredibly low dewpoints of -80°F (-62°C). The honeycomb wheel rotates continuously through resin drying, to desiccant regeneration to desiccant cooling, always providing an efficient flow of dry air for drying the resin. The blowers used for air movement are designed and manufactured for optimized air flow at a wide range of levels to match production requirements. Exclusive turbo-compressors adapt dry air delivery by variable frequency drives to production needs. The result is ‘drying on demand’ and significant energy savings. Additionally, anti-stress technology is built into the dryer to prevent overdrying of the resin. As the temperature at the top of the drying hopper begins to approach the set-point drying temperature (indicating a production slowdown or stoppage), the anti-stress feature automatically reduces the air flow to the hopper, aligning the drying process to the rate of production, but without reducing the drying temperature. A more compact hopper, with a special patented geometry and unique thermodynamic properties, called ‘OTX Original Thermal Exchanger’, allows optimal drying performance as each pellet is uniformly subjected to the drying air flow, which dries the resin more quickly for more efficient startups. Fitted with a color touchscreen, controlling the dryer enables the incorporation of a range of external communications. For operation, users input the resin to be dried (from an on-board library) and the production throughput, and the dryer literally does the rest.
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Hygroscopic resins are characterized as capable of absorbing moisture into their chemical structure that adversely affects the product’s performance once molded or extruded.
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BIOCOMPATIBLE
LED Curable Adhesive Nanosilica Filled LED405Med Meets ISO 10993-5 for cytotoxicity Outstanding optical clarity Refractive index 1.50 High dimensional stability
Coefficient of thermal expansion 35-40 in/in x 10-6/°C
Cures by LED light Suitable for heat sensitive components
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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
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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ISO 13485:2016
HUMAN FACTORS ENGINEERING
5IVE THINGS developers need to know
W
earable medical devices are notoriously challenging design projects. One way to increase your chances for success is by considering the unique substrate to which it will stick – the skin.
depends on whether the device does its job effectively. When it comes to managing a chronic disease, stakes are higher than they are with other wearables, such as fitness watches. While it’s still important for those, or other activity trackers, to provide accurate readings, there is less on the line at the end of the day.
Unlike a metal or plastic, skin sweats, grows hair and completely regenerates itself every two weeks or so. It also changes with health, diet, activity level, environment and age. Often patients may have underlying medical conditions, such as diabetes, and thus their skin requires special attention. Stick-to-skin devices that don’t take these factors into account could result in manufacturing issues, device failures or even harm to the wearer, which can impact a project’s timeline and budget. The good news is that most mishaps are largely preventable. Here are five variables you must accommodate in order to stay on track when developing your next stick-to-skin wearable product.
It’s also not uncommon for the “less is more” saying to be true for stickto-skin devices. Overdesigning a device with the intention of optimizing performance can backfire and create more complications than it will solve. As it applies to material selection, overdesigning might mean selecting too strong of an adhesive for the intended application. Selecting an adhesive with a two-week wear time for a device that only needs to be worn for five days could result in harm to the user, so it’s important to keep it simple. 2. WEARER CHARACTERISTICS: As mentioned previously, skin is a living, breathing organ that’s constantly regenerating itself, making it unlike other substrates. Those characteristics coupled with variables including age, ethnicity, diet, culture and environmental factors all play into how successful the device will be in a given scenario. For instance, if the wearer is a baby or elderly, their skin will be more fragile than a healthy young adult. Teenage skin, on the other hand, usually produces more oil, creating its own set of stick-to-skin challenges. 3. LOCATION: Where the device will be worn on the body matters. In some areas, our skin is thicker, hairier and/or oilier, influencing how sensitive the skin will be in that location. Device design and adhesive selection, particularly if they’ll come into contact with skin, need to take into account where it will be worn and the characteristics unique to that region of the body. For applications that require wear on thin or fragile skin, like on
1. DEVICE OBJECTIVE: Prior to kicking off the design process, it’s important to build a thorough understanding of the device - who it will be used on and what its end goal will be. Think about what the wearer relies on the device to do for them every day. For example, patients with diabetes rely on their glucose monitors to track how much sugar is in their blood. This type of device requires intricate design and high attention to detail because the wearer’s health and independence
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HUMAN FACTORS ENGINEERING
DEL R. LAWSON, RESEARCH AND DEVELOPMENT MANAGER IN 3M’S MEDICAL SOLUTIONS DIVISION AND KRIS GODBEY, APPLICATIONS ENGINEERING AND TECHNICAL SUPPORT SPECIALIST IN 3M’S MEDICAL MATERIALS AND TECHNOLOGIES DIVISION DISCUSS EVERYTHING YOU NEED TO KNOW ABOUT SKIN BEFORE DESIGNING A WEARABLE MEDICAL DEVICE.
the face or on the elderly or babies, silicone adhesives might be best. If the device needs to stay in place for longer periods of time on an area that can withstand stronger adhesive strength, an acrylic solution may be the better option. It’s a good idea to discuss the best options with your materials supplier. 4. W EAR TIME: In order for the device to fulfill its purpose, it has to stay together and adhere to skin for its entire intended duration without causing harm. That means selecting the right combination of adhesive and backing to attach the device, as well as the material housing the device. Careful selection of both will help to ensure the skin is able to breathe and flex as needed while the device is in place. 3M ©
Generally, a smaller, lighter device is better for sticking over multiple days than a larger one. Devices that are attached to the skin during high intensity activities, such as running or biking, may call for an aggressive adhesive. Keep in mind that humans are living, moving, breathing, flexing beings, and therefore what we put on our bodies should accommodate this. Checking with your materials supplier about any wear time studies they’ve conducted will help to increase your understanding on how adhesives are expected to perform in real-life applications.
technology can speed along the process. They will be able to offer support and tips on which adhesives are able to withstand manufacturing, as well as those that work well with skin. In every case, before using any product in full-scale production, device manufacturers should conduct their own tests to determine whether the product is of acceptable quality and is suitable for their particular purposes under their own operating conditions.
5. M ANUFACTURING PROCESSES: Materials that might work well in your device’s design may not withstand the stress of manufacturing. Consider how the device will be manufactured early in the design process to avoid potential redesigns, delays and additional costs. If your device or its materials require sterilization, test them with your desired methods to help determine whether or not it will be compatible with your project and application. Additionally, engaging adhesive experts who have experience designing, testing, researching and innovating adhesive
Before your stick-to-skin product will be ready to bring to the masses, it’s important to consider the human variables at play. Engage your materials supplier early on in the process. Collaborating with materials experts at the start will set your project up for success and help you avoid future risks later in the process. Additionally, utilizing product selector tools during the design phases will help ensure you are using the best materials for your application.
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ELASTOMERICS
BRIAN REILLY, BUSINESS DEVELOPMENT DIRECTOR, BIOMATERIALS, NUSIL â&#x20AC;&#x201C; PART OF AVANTOR, DISCUSSES HOW TO ENSURE THE OPTIMAL USE OF HIGH-CONSISTENCY RUBBER SILICONES.
SHAPING MEDICAL DEVICES
fabrication methods, including extrusion, calendering and compression or transfer molding. Compared to other silicones such as liquid silicone rubber (LSR), HCRs are generally stronger with more robust physical properties. Another key aspect is their proven history of use in countless approved implant and non-implant applications.
H
VERSATILITY IN HCRS The physical properties and process considerations of HCRs are important to understand along with the advantages that both peroxideand platinum-catalyzed solutions provide.
igh-consistency rubber silicone (HCR) is a versatile material with a long history of use in medical devices and other industries. Commonly found in a wide variety of applications, such as tubing, balloons, sheeting and some molded parts, HCRs consist of a high molecular weight polymer combined with silica to produce a silicone that has a clay-like consistency in its uncured form.
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A key advantage of peroxide-catalyzed systems is that their curing mechanism is not initiated until the HCR is exposed to heat. This translates into a very long work time which is beneficial for molding or extrusion. Consider that peroxide-catalyzed systems call for a post-curing process to remove residual byproducts. This curing mechanism provides unique elastomeric properties that can be useful in balloons, or similar applications where 'tension set' is important. If a balloon needs the ability to be inflated and then return to its original shape when deflated, a peroxide-cure HCR may provide the best solution.
HCRS IN MEDICAL DEVICES Medical device manufacturers often choose silicone because of its established biocompatibility pedigree, broad processing parameter ranges and excellent physical properties.
Platinum-catalyzed systems typically consist of two components; one contains the platinum catalyst, and the other contains hydride functional crosslinkers and cure inhibitors. When combined, the HCR retains its pre-cure consistency for one to two hours. A key advantage of platinumcatalyzed HCRs is the ability to heat-accelerate the cure for faster cure times and increased throughput without corrosive byproducts. Platinumcatalyzed HCRs typically yield much higher physical properties than traditional peroxide-catalyzed HCRs, which may be valuable for specific applications that use molded or extruded components.
One of HCRs key appealing characteristics is versatility. It can be processed using different
HCR PROCESSING When using HCRs, certain steps must be taken depending on the fabrication methods. For example, prior to molding or extruding, they need WWW.MEDICALPLASTICSNEWS.COM
ELASTOMERICS
to be processed with a two-roll mill. The mill imparts shear to the material and modifies its consistency, making it softer and able to flow more easily through the die or mold. If the HCR is a two-part material, each part will need to be separately softened on a cooled mill before being combined to prevent premature curing. If the HCR is a one-part material, it will also need to be mill-softened prior to use. Different end-use applications call for different fabrication methods. For example, in a medical device that incorporates silicone tubing, the most efficient production method would be extrusion. Once the processing method is established, consider additional requirements: • What properties should the tube have? • Does it need to be soft and flexible, or stiff and rigid? These and other factors can help decide whether a device requires a peroxide-cure or platinum-cure system. The broad processing parameters of silicone elastomers make them ideal for molding. For molded products, like hydrocephalic shunts, consideration needs to be given to the shunt’s valve mechanism. With this product type, the device manufacturer should choose a HCR that reliably provides the proper modulus, tension set and other elastomeric properties to ensure the valve functions properly. HCRs are often calendered into flat sheets that may be die cut. A major application for this processing method is a gasket used as a device seal. With a peroxide-cure HCR, it’s possible to create gaskets with self-adhering properties. Stored properly, an uncured peroxide HCR sheet has almost infinite shelf life. A supplier could fabricate the sheet, package it and ship it to another manufacturer who die-cuts the gaskets which are pressed in place and then cured to seal completely. KEY FACTORS FOR USING HCRS The versatile material properties, processing features and cure options make HCRs well-suited for a broad range of medical device applications. It is important to consider the following factors when choosing HCRs. • Integration/interaction with other materials: One of HCR’s advantages is the ability to incorporate additives into the pre-cured formulation. • How additives or other materials within the device interact with the silicone and the molding process: If any of the additives are temperaturesensitive or adversely interact with formulary components resulting in an incomplete cure, the silicone supplier may be able to customize solutions to address the issue. WWW.MEDICALPLASTICSNEWS.COM
• Avoiding crosscontamination: Platinumcured HCRs can be negatively impacted by chemicals that may come into contact with the silicone prior to curing. These contaminants can partially or completely inhibit the platinumcatalyzed cure system. To prevent contamination, clean manufacturing practices should be followed. This includes having dedicated instruments like spatulas for subdividing HCR and cleaning all surfaces between uses. •F lexibility in HCRs: Since no two medical devices or fabrication processes are exactly the same, leading-edge silicone providers will have solutions that provide greater flexibility for the manufacturing process. An optimization system can help device engineers optimize process requirements, such as work time and cure profile. FINAL CONSIDERATIONS FOR HCR SELECTION There is a great advantage to working with a silicone supplier with extensive experience in providing HCRs for medical devices. Suppliers that can demonstrate expertise in working with regulatory authorities, along with a focus on supplying materials specifically for medical device applications, can help clear regulatory hurdles efficiently. When evaluating suppliers, consider whether they have a robust quality system with ISO 9001 certification, deep knowledge of ISO 13485 quality management requirements for medical systems and experience with the U.S. Food and Drug Administration Master File submissions. A medical device manufacturer should also work with a partner that can provide support throughout the entire design and regulatory submission process. A materials partner with established regulatory body relationships can prove invaluable, saving time and money, while navigating the path of getting a device to market.
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POWER AND BATTERIES
SHANE CALLANAN, DIRECTOR OF ENGINEERING TECHNOLOGY, ADVANCED ENERGY INDUSTRIES, REFLECTS ON THE EVOLUTION OF MEDICAL DEVICE POWER SUPPLIES – AND THE NEW REQUIREMENTS SHAPING THEIR FUTURE.
A
ccording to the New England Society of Medical Engineering, up to 10,000 people per year were electrocuted in American hospitals during the late 1960s and early 1970s as a result of leakage current from defective electronic medical equipment. Defined as the flow of electric current in an unwanted conductive path under normal operating conditions, leakage current is a direct function of the line-to-ground capacitance value. As long as the equipment is grounded, these currents will flow in the ground circuit and present
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no hazard. If the ground circuit is faulty, however, the current flows through other paths such as the human body. With staggering statistics prompting the healthcare industry to conduct a wide range of studies to examine the risk of ventricular fibrillation by electric shock, researchers eventually determined that as little as three micro amps (0.000003 amps) of voltage applied directly to a portion of the heart during a critical part of the cardiac cycle could cause lethal arrhythmia. It is a small amount, considering a lightning strike – which many people survive – contains a minimum of 5,000,000,000 micro amps (5000 amps). But for patients with compromised health, even the smallest voltage can be fatal. Medical devices, which require a consistent and safe power supply, have some of the tightest leakage current requirements of any industry. And it is understandable, given the high risk involved and a history of tragic outcomes. Up until the 1970s, when the switch mode power supply (SMPS) began gaining popularity, the backbone of power conversion was the linear Direct Current (DC) power supply, a design requiring a large transformer
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2019.9.25-27
Shanghai World Expo Exhibition & Convention Center
450+Exhibitors 25,000+Visits 900+Conference Delegates 60+Professional Presentations
China Largest Exhibition Dedicated to Medical Device Design & Manufacturing
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POWER AND BATTERIES
to raise or lower the alternating current (AC) voltage and produce a clean DC voltage. Because the transformer size is indirectly proportional to the frequency of operation, the power supply is typically large and heavy but best for sensitive analog circuitry. Alternatively, a SMPS not only converts the AC line power directly into a DC voltage without a transformer but also converts raw DC voltage into a higher frequency AC signal that is used in the regulator circuit to produce the desired voltage and current. The result is a transformer that is considerably smaller and lighter than a linear power supply—by as much as 80 percent—and best suited for portable devices. Generating less heat, the SMPS is often more efficient than linear but transient response times can be up to 100 times slower, which presents challenges—and the need for expertise—in manufacturing. Particularly as medical devices increasingly use sensitive analog electronics, wireless technologies and microprocessors, it is imperative that during the manufacturing process, power supplies meet customer needs as well as essential standards, including electromagnetic compatibility (EMC) compliance.
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For example, health professionals performing cosmetic procedures with medical-grade lasers want and need high-power density and reliability incorporated into a portable power supply that has longevity, black box recording capabilities, seamless connectivity and firmware that is easy to upgrade. With the amount of allowable leakage current specified to ensure that direct contact between a patient and any medical equipment is highly unlikely to result in electrical shock, manufacturers must deliver a power supply that not only meets design specification, but also includes appropriate isolation barriers, to minimize leakage current and ensure the safety of both patient and clinician. Even with the challenges of design and compliance ever present, as new equipment can take years to develop and refine before reaching the market, advances in power supplies have enabled remarkable improvements in surgical procedures alone. Common knee replacement surgeries, the first of which were performed in 1968, are one of the most successful medical procedures today. Many well-equipped surgeons are now operating with the help of 3D models, which are fed into the power supply. In the event the surgeon tries to remove too much or too little of the knee in respect to the 3D model, the power supply shuts off immediately to avoid any errors. The impact of this new approach has been tremendous, with success rates jumping from approximately 50 percent to 90 percent or higher. Advanced power supplies have also enabled lifesaving thermal solutions. Among the many applications utilizing heating and cooling therapies, doctors are using helmets with automatic and interval temperature adjustment capabilities designed to prevent brain damage in newborns. Though invisible, energy is ubiquitous in every facet of life and nowhere more critical than the field of healthcare, where research is accelerating, and more advanced devices and equipment are launching to market at a rapid pace. Driven by a gradual shift in focus to patient care and speed of recovery, the need for more accuracy in terms of treatment requires new diversity in supply, from Radio Frequency (RF) amplifiers that power ultrasonic equipment to thermal solutions for heating and cooling. While change has been slow and significant progress achieved only in the last ten years, advanced power supplies have undoubtedly provided the medical industry with scalable solutions enabling smaller, more reliable and powerful devices that reduce cost, complexity and human error while heralding a new era in medical innovation.
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MEDTEC CHINA
MEDTEC CHINA WILL HOST ITS 15TH ANNUAL EVENT THIS SEPTEMBER.
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ince its first event in 2005, nearly a thousand medical design, research and development, raw materials, accessories, processing technology and manufacturing service suppliers from China's medical device industry have come together at Medtec China. The event’s audience is comprised of medical device manufacturers, decision makers, purchasing staff, research and design engineers, product engineers and quality inspectors. The show aims to provide attendees with the opportunity to find the parts and components necessary for research and development, raw materials, design and manufacturing technologies and solutions. The Chinese medical device market claims to be growing at a compound annual rate of 16.8%, and according to the China National Pharmaceutical Industry Information Centre, among device types, imaging devices, in vitro diagnostics and high-value consumables are the top three sectors, accounting for 19%, 16% and 13%, respectively, of the total market. Therefore, growth is anticipated for this year’s event. Medtec China expects 400 exhibitors, and more than 20,000 visitors from different regions in the world to be in attendance for this year’s show. The predicted exhibitor number for 2019 is significantly higher than the total number of exhibitors for last year’s show which was 354.
The event will contain multiple features such as an exhibitor’s theatre, MDiT forum and a regulation summit. There will also be a conference schedule which will be posted on the event website ahead of the event. Registration is still open for this design and manufacturing event which will provide attendees the opportunity to meet with thousands of global suppliers, and also offer the opportunity to further explore regulatory updates in China, Europe and the United States. Medtec China will take place from 25th to 27th September 2019 in Shanghai World Expo Exhibition and Convention Center, China.
MEDTEC CHINA
ONE OF THE GLOBAL MEDTECHWORLD SERIES EXHIBITIONS
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3 things to look out for at MD&M Minneapolis 1
ENGINEERING HEADQUARTERS: Here, there will be demonstrations, case studies, panels and presentations on the newest advances in many topics including robotics, IoT and packaging
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25TH ANNIVERSARY CELEBRATIONS: To celebrate MD&Mâ&#x20AC;&#x2122;s 25th anniversary special events will be taking place on the expo floor
A SPRAY-ON SKIN DEVICE HAS BEEN DEVELOPED IN ISRAEL WHICH AIMS TO HELP TREAT BURNS AND WOUNDS QUICKLY, AND IN A PAINLESS WAY.
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BOOTH CRAWL: There will be a tour of exhibitor booths on the Wednesday afternoon during the event where attendees can see tech tricks and network with others in the industry
Have you listened to the Medtalk Podcast yet?
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he SpinCare device is able to spray a see-through, skin-like polymer dressing directly onto a wound, and for around 24 hours the dressing is able to withstand water. Once the skin has healed underneath, the dressing then peels off naturally. An advantage of this treatment option is that only one application is required per wound. There are currently nine devices which have been distributed free of charge to places where the device has received regulatory approval, including hospitals in Israel and Europe. NanoMedic plans to launch SpinCare on the market by mid2019 initially in Europe, and then in the United States following Food and Drug Administration (FDA) approval.
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he MedTalk Podcast brings together the editor of this magazine, alongside the editors of our sister titles Med-Tech Innovation, Digital Health Age, and European Pharmaceutical Manufacturer.
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On the podcast the editors discuss the latest news within the medical technology, digital health and pharma industries in a light hearted way. You can listen to the podcast on Soundcloud, iTunes and Spotify.