NORTH AMERIC AN EDITION
MEDICAL PLASTICS news DEVELOPING A COATING EFFECTIVE AGAINST COVID-19 THE RISE OF ROBOTICS AND AUTOMATION DESIGNING MEDICAL COMPONENTS
COMPLEX CHALLENGES NEED STRAIGHTFORWARD SOLUTIONS
How complex obstacles are removed with clear-cut technology ISSUE 15
Jul/Aug/Sept 2020
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ADVANCING MEDICAL PLASTICS
So clear it’s like it’s not even here: highly transparent CYROLITE® for diagnostic applications.
We invented CYROLITE® over 40 years ago – and we’ve used the time ever since to perfect its properties. The result is highly advanced acrylic polymers that boast outstanding optical properties such as superior UV transmittance. At the same time, CYROLITE® offers excellent flow properties, thus enabling them to be molded into extremely thin-walled components. It goes without saying that CYROLITE® meets all the relevant USP Class VI, ISO 10993-1, and REACH standards. For more reasons why CYROLITE® is the clear choice, visit www.cyrolite.com.
CONTENTS MPN North America | Issue 15 | Jul/Aug/Sept 2020
Regulars
Features
3 Comment Laura Hughes writes about how healthcare is increasingly transitioning into our homes
13 The journey How BGU and the NIBN are developing novel surface coatings
4 News focus
19 Three things you should know Caplugs lists three topics to discuss in detail when quoting a new medical component
5 Opinion Accumold demonstrates the importance of a collaborative relationship with your chosen supplier 6 Digital spy 9 Therapy area focus: Oncology 10 Cover story BioInteractions explains how high-performance multiphase materials enhance biocompatible performance
20 Keeping up with demand Emerson highlights the latest advances in ultrasonic welding 22 No more pain Avery Dennison Medical describes the role of skinfriendly adhesive in PPE
24 Back to the future
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CREDITS editor | laura hughes laura.hughes@rapidnews.com advertising | sarah livingston sarah.livingston@rapidnews.com
Editor’s Comment
head of media sales plastics & life sciences | lisa montgomery
LAURA HUGHES
head of studio & production | sam hamlyn
Transitioning healthcare
graphic design | matt clarke junior designer | ellie gaskell publisher | duncan wood
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ISSN No: 2632 - 3818 (Print) 2632 - 3826 (Digital)
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TO OUR HOMES
uring the Covid-19 pandemic we have all been forced to spend a large amount of time in our homes. Activities such as working and studying, which are typically done in schools and external places of work, have in many cases been shifted to take place at home. Although I’m sure many parents and children are looking forward to when schools are a safe environment for them to return to, employees who can work from home may find this is preferable or an option that suits their lifestyle. There’s no need to travel, and any help you might require from a colleague is only a phone call or text away. In the same way, healthcare devices that can be used in the home are becoming increasingly desirable. For instance, in the case of a life-long indication such as chronic kidney disease, dialysis can now be done from home. This involves training for the person who would be receiving the treatment, as well as one other person who would be able to assist them with this from the comfort of their own home. Hemodialysis often takes place around three times a week in a center, with sessions lasting for a few hours each time. This means the option of carrying out this treatment at home provides those with chronic kidney disease with the ability to better fit their treatment around their daily schedule.
Additionally, Wessex Cancer Trust announced that as part of a new project, MacMillan and the National Health Service within the UK, would be offering chemotherapy treatment by trained paramedics or nurses to cancer patients living within a certain region. As chemotherapy is often associated with unpleasant side effects, it is clear to see why many people would opt to receive this treatment at home if this was available to them. We are witnessing a shift in the management of our healthcare. Previously we queued up at surgeries to book appointments with healthcare professionals, and we waited on the phone at a certain time to book an appointment, but now online booking systems are slowly becoming the norm. There are also phone numbers other than the emergency line to call for instant advice from a trained professional from any location. The availability of these medical interventions from home, and methods of communicating with healthcare professionals, were of course available before the Covid-19 pandemic. However, as restrictions are lifted, I think we will all be returning to a different version of ‘normal’, and the popularity of healthcare management from the comfort of our own homes will continue to rise.
Type 1 diabetes is another chronic condition which allows people to predominantly manage their monitoring and treatment from home on a day-to-day basis. Advances in healthcare allow those with the condition to only need to visit healthcare professionals around every three months.
Healthcare devices that can be used in the home are becoming increasingly desirable.
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NEWS FOCUS
The role of single-use plastics during the pandemic MPN EDITOR LAURA HUGHES SAT DOWN WITH ALEXANDER SILVESTRE, GLOBAL DIRECTOR, HEALTHCARE, AMERICAS AT INEOS STYROLUTION AMERICA, TO DISCUSS THE ROLE OF SINGLE-USE PLASTICS DURING THE COVID-19 PANDEMIC. Please explain a little bit about yourself, and your role within your organization. I am responsible for setting the strategic and commercial direction for our company within the healthcare industry. Additionally, I develop and maintain our global policy to establish guidelines related to our products for pharmaceutical applications and use in medical devices. Do you think single-use plastics have been essential for the healthcare sector during the Covid-19 pandemic? As we’ve mitigated our way through this pandemic, implementing measures to limit the spread of infection has become increasingly paramount. There is no denying that single-use applications have advantages in this regard. As the name implies, single-use medical devices are used for one procedure, and then discarded. For applications with potential to be in contact with biohazardous materials, a single-use application, when properly used and disposed of, can help control the spread of infection. What do you feel are the benefits that single-use plastics offer as opposed to reusable plastics within this field? Generally, plastics are not categorized by single-use versus reusable. This definition refers to how the end application becomes utilized. In fact, some polymers can be used in both situations. The key is for plastic suppliers to work with the medical device manufacturer to determine product suitability. If single-use plastics are to play a key role within our healthcare sector going forward, what needs to change, if anything? I don’t believe that anything needs to change drastically. Rather, it is important to strengthen relationships between medical device manufacturers and raw material suppliers throughout the development process.
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For decades, plastics have been established as a primary raw material for diverse applications across healthcare sub-segments (labware, respiratory and drug delivery, IV and fluid transfer, mobile/digital health, surgical devices, and medical packaging). Through the material selection process, medical device designers should balance achieving certain physical or chemical properties while ensuring that the products are compliant with current and future trends. Enhancing collaboration with supply partners helps medical device OEMs successfully bring improved products to market, and benefit the patient and/or healthcare provider, all while meeting regulatory mandates. Do you think the Covid-19 pandemic has transformed the way people see single-use plastics? At the onset of this pandemic, there was an overwhelming global outcry that medical professionals had appropriate equipment. Here is one thing that I hope people take away with respect to this crisis and plastics: Whether it was related to the diagnosis of the disease (blood analysis kits), treatment of patients (ventilators, IV sets), or personal protective equipment (face shields), plastics were a key component of those respective supply chains helping medical device manufacturers quickly produce and ship equipment to frontline healthcare professionals.
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OPINION
PINION
THE PERFECT MATCH AARON JOHNSON, VP OF MARKETING AND CUSTOMER STRATEGY, ACCUMOLD, HIGHLIGHTS THE IMPORTANCE OF A COLLABORATIVE AND HEALTHY RELATIONSHIP WITH YOUR CHOSEN SUPPLIER.
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s we began the New Year, few could have predicted the landscape change that we would all be dealing with six months later. Since then, much has been written about the effects of the Covid-19 pandemic on health, society, politics, and the economy. There were times as most of the leading economies in the world went into lockdown when there seemed to be huge and unprecedented uncertainty, and the situation seemed a little unreal. But as communities, we are nothing if not resilient, and now in July there is light at the end of the tunnel, and attention is full square on recovery. At Accumold, we remained fully operational throughout the lockdown, and we worked closely with our customers to maintain continuity of service. Accumold is the only micro molding company in North America to be able to claim to be truly vertically integrated, and at times like this that has proved to be vital. One thing Covid-19 has laid bare is the fragility of supply chains, and also the fragility of relying on third parties for service or supply. As we control mold building, micro molding, validation, volume production, and automated assembly all under one roof, we were able to maintain absolute control. What we found interesting in the lockdown is that innovation didn’t stop. Indeed, we noticed a spike in customers presenting us with projects that had been side-lined for whatever reason, and which as they had a little more time to take stock, they had brought back to life. Some of these new products and components are truly amazing, and in many instances, we proved what was thought to be impossible to manufacture, that in fact we could find a way. As a manufacturer in normal times, we receive a lot of business from companies that have been told by other precision and micro molders that their products are not viable to manufacture. This is because we have an over 30-year pedigree pioneering the art and science of micro molding, and this means that we are able to push the boundaries of what is deemed possible. As we all move out of lockdown now, and with the economy licking its wounds, the manufacturers that will succeed will be those that continue to innovate, and as such we are getting more and more enquiries now from organizations that recognize our realistic and pragmatic solutions-oriented approach to micro molding.
One thing Covid-19 has laid bare is the fragility of supply chains. healthy partnership relationship with their chosen supplier as early in the product development process as possible. This is because it is the micro molder that understands the vagaries of the process, and an innate understanding of the rules of Design for Micro Molding (DfMM) are vital to mitigate the production of sub-optimal parts and costly and timely design reiterations. It is this I think that explains the robustness of our backlog today. In times of crisis, customers regroup and analyze their supply chain and their partners, and to come back stronger they need to be able to rely on the experience and know-how of veterans in the space that can allow them to capture market share through innovation.
When you boil it all down, what most if not all companies working in the area of micro molding need is to enter into a truly collaborative
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DIGITAL
spy
REGULATORY UPDATE
MEDTECH UPDATE
WWW8.HP.COM
HP partners with BASF to launch polypropylene material
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ogether, multinational IT company, HP, and chemicals company, BASF, have developed a new HP 3D high reusability PolyPropylene (PP) that aims to strengthen production within the medical sector. HP claims it has the same properties as existing PPs used in injection molding, and is ideal for piping, fluid systems, and containers. The PP material is reportedly durable enough to create cost effective production parts via its additive manufacturing systems, and the material has been developed for HP's Jet Fusion 5200 3D Series of systems. In order to increase the reach of its PP material, HP has forged partnerships with multiple companies. This includes Oechsler, Extol, GKN
Powder Metallurgy/ Forecast 3D, Henkel, and Prototal. Ramon Pastor, interim president of 3D printing and digital manufacturing at HP, said: “The response to the Covid-19 crisis is a watershed moment for the industry. HP and its partners have 3D printed more than 2.3 million parts to bridge supply chain gaps, enable local production, and help healthcare professionals on the frontlines.” “As we navigate this new landscape, we continue to execute on our strategy and push innovative new 3D printing materials, solutions, and partnerships forward to help our customers reopen manufacturing and deliver disruptive innovation for the world’s industries,” Pastor concluded.
HP ©
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ec.europa.eu
TÜV SÜD PRODUCT SERVICE DESIGNATED AS A NOTIFIED BODY UNDER IVDR The designation of this organization means there are now four notified bodies under the In Vitro Diagnostics Regulation (IVDR). Those who have previously gained notified body approval under IVDR include: DEKRA Certification, BSI Assurance UK, and BSI Group The Netherlands.
IVDR came into force in 2017, and products which are already approved must be recertified by 26th May 2022. IVDR regulates market access for in vitro diagnostic medical devices on the European market. This regulation will replace the EU’s current directive on in vitro diagnostic medical devices.
NEWS UPDATE
www.essentium3d.com
3D PRINTING FIRM PROVIDES ESSENTIAL PPE
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D printing firm, Essentium, is working with the Texas Division of Emergency Management, the Texas Military Department, and other groups at a State level, to supply Personal Protective Equipment (PPE). PPE will be essential as businesses reopen and lockdown restrictions are eased as a result of the Covid-19 pandemic. The organization has shifted its capacity in its Texas operations in order to produce protective face mask kits based on FDA emergency use authorization.
The resuable mask frames are made with Essentium PA (thermoplastic nylon), to allow for easy cleaning. The frames are combined with a single-use, replaceable filtration media that is ASTM level 2 certified. Currently, Essentium has produced more than 60,000 3D printed face mask kits for the State of Texas. Blake Teipel, CEO and co-founder of Essentium, commented: “The State of Texas is creating a potential blueprint for sustainable access to PPE. We are proud to be part
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of this initiative, and I commend Governor Abbott’s visionary leadership in setting a path of clarity and watertight coordination in its creation and ensuring it is subject to the highest level of oversight.”
DIGITAL SPY
EVENT UPDATE
www.advamed.org
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The MedTech Conference will be an all-virtual experience for 2020
he virtual conference, which is powered by AdvaMed, will include a mixture of live and ondemand content for all registrants. From early September, anyone who has registered for the event will be able to access the on-demand services via the virtual conference platform. The MedTech Connect platform which partners the conference plans to go live in August with participants able to view other users and begin requesting meetings from then. Topics such as regulations, digital health, artificial intelligence, cybersecurity, and overseas markets will be covered in the conference sessions. Talking about the news, Scott Whitaker, president and CEO, AdvaMed, said: “The theme of this year’s conference - United by Purpose
- has never been more appropriate. While we may be unable to meet in person in Toronto, the show will go on!” MedTech Conference co-chair, Caroll Neubauer, concluded: “While we are of course disappointed we will not meet in Toronto this fall, we have committed to bringing our conference to that beautiful and dynamic city in 2022.”
Avishay Bransky, CEO of PixCell Medical, discusses its new FDAcleared platform.
advances.sciencemag.org
RESEARCHERS ARE 3D PRINTING SENSORS DIRECTLY ON TO EXPANDING ORGANS he new technique which has been developed by researchers at the University of Minnesota allows the 3D printing of hydrogel-based sensors directly on to organs such as the lungs, that change shape or distort when expanding and contracting. It works through the
POINT
www.pixcell-medical.com
MEDTECH UPDATE
T
talking
use of motion capture technology - similar to that used in films. The research is said to be the ‘next generation’ of the 3D printing technique which was discovered two years ago and involved the printing of electronics directly on to the skin of a hand that moved left to right or rotated.
Michael McAlpine, a senior researcher on the study, explained how the research is “pushing the boundaries of 3D printing in new ways we never even imagined years ago.” He added: “The broader idea behind this research, is that this is a big step forward to the goal of combining 3D printing technology with surgical robots.” Future applications for this research could include the diagnosing and monitoring of the lungs of patients with Covid-19, as well as 3D printing sensors on to a pumping heart. The research is published in the journal, Science Advances.
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What has PixCell Medical developed? PixCell Medical has developed an FDA-cleared platform intended for use at the Point-OfCare (POC) that can deliver lab-quality full five-part differential Complete Blood Count (CBC) results and comprehensive abnormal cell flagging. PixCell’s HemoScreen diagnostic platform shortens diagnostic results delivery from days to minutes, saving significant time and costs. PixCell delivers accurate readings of 20 standard blood count parameters, and the HemoScreen analyzer requires no maintenance or calibration, making it ideal for use at the POC. How is this different to other blood diagnostic devices? Other blood diagnostic devices on the market use imaging, as PixCell does, but they use a chip and not a cartridge. PixCell has lab-on-acartridge technology, and combines flow and imaging cytometry. The cartridge automatically prepares a sample, simplifying the whole blood testing process. When did this device gain FDA approval? In November 2018. How will this technology be used in the future? If we can make testing more accessible, people everywhere can gain better healthcare services, and we can potentially manage future outbreaks more efficiently to save lives.
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BIOCOMPATIBLE
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ONCOLOGY
Therapy FOCUS An alternative treatment RAMYA SRIRAM, DIGITAL CONTENT MANAGER AT KOLABTREE, A FREELANCE PLATFORM FOR SCIENTISTS, DISCUSSES THE DISCOVERY OF A MEDICAL DEVICE WHICH AIMS TO IMPROVE COMFORT FOR CHEMOTHERAPY PATIENTS.
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hemotherapy has a considerable number of unpleasant side effects, but 40 percent of patients report that the most troubling is oral mucositis. Characterized by sores and inflammation in the patient’s mouth, oral mucositis has a significant impact on a patient’s quality of life and the implications can be severe. Although chemotherapy drugs attack rapidly dividing cells, they do not distinguish between friend and foe, which means they attack healthy tissue, as well as cancerous cells. Circulating chemotherapy drugs in the bloodstream reach the mouth and break down the mucous membranes lining the cheeks, tongue and other areas, causing painful sores, bleeding and inflammation. The condition occurs in about 80 percent of high-dose chemotherapy patients and can lead to a patient stopping eating and drinking and may necessitate a feeding tube or IV. TREATMENT Cryotherapy - cold therapy with ice chips, has been the go-to treatment for oral mucositis. Numerous studies have tried different medications to reduce the severity of oral mucositis, but none have shown much success. DISCOVERY OF THE CHEMO MOUTHPIECE When he was diagnosed with Hodgkin’s Lymphoma, engineer David Yoskowitz experienced oral mucositis first-hand. The treatment - ice chips - were nauseating and inefficient. After his recovery, Yoskowitz knew there had to be a better approach. He created a simple, effective, easy to use device for patients to use during chemotherapy treatments at home or in hospital. His product, the Chemo Mouthpiece, is an intraoral ice pack that cools the entire oral cavity. The patient freezes the device at home and puts it in their mouth during treatments to effectively reduce the severity of oral mucositis. The device includes two chambers, a centre core filled with filtered water, and an outer section filled with proprietary saline, which can reach freezing temperatures without solidifying. Two tubes run through the device so the patient can breathe comfortably.
Kolabtree became involved when Yoskowitz was assembling a team to bring the product to market. The company posted a project on Kolabtree, looking for an experienced medical researcher and writer to produce a whitepaper on oral mucositis. Experienced cancer research scientist Dr Kiranam Chatti stepped in to collate relevant literature and summarize information in a report. The company was able to use the findings to help generate interest in the product ahead of its launch, uploading the whitepaper to its website to create an information hub. WHERE ARE WE NOW? The product was launched in the US in May 2019, with the first unit shipped to coincide with the Oncology Nursing Society Convention in California. It is FDA registered and patients in the US can now order directly from the company’s website. The organization currently works with distributors in 34 countries to supply the product to patients all over the world. Chemo Mouthpiece is also working on a clinical trial to compare its product’s efficacy against best supportive care in a cohort of patients being treated for breast or colorectal cancer.
Chemo Mouthpiece is an intraoral ice pack that cools the entire oral cavity. WWW.MEDICALPLASTICSNEWS.COM
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COMPLEX CHALLENGES NEED ARJUN LUTHRA, COMMERCIAL DIRECTOR, BIOINTERACTIONS, EXPLAINS HOW HIGH-PERFORMANCE MULTI-PHASE MATERIALS ARE A STRAIGHTFORWARD SOLUTION TO ENHANCING BIOCOMPATIBLE PERFORMANCE. BIOCOMPATIBILITY: A COMPLEX CHALLENGE Biomaterials are routinely used in surgical therapies for shortterm and long-term applications. These materials constantly encounter major impediments such as, inflammation, infection, and thrombosis. These complex challenges lead to poorly performing devices as well as increased risks for patients.
Biological processes are inherently complex and are governed by a variety of factors, known as surface properties. The surface properties include chemistry, topography, elasticity, surface free energy and charge. These various properties will moderate protein as well as cell interactions and are involved in governing the host response.
The difficulties are caused by biological events occurring where the biomaterial surfaces interact with the body’s components. Revolutionary biomaterials actively confront the complex nature of these biological events to improve medical device performance and enhance therapies available to patients.
Proteins promote platelet adhesion to a varying degree, and this is dependent on the substrate and the flow conditions. Fibrinogen is a major contributing factor to the process of biomaterial-induced thrombosis. It mediates platelet adhesion, links platelet aggregates together and stabilizes the thrombus as a fibrin polymer in low stress conditions. The vWF circulates in plasma and mediates platelet tethering, translocation, and adhesion to injured endothelium in high stress conditions. Immobilization and shear induce a conformational change in vWF which enhances binding and results in platelet adhesion.
BIOMATERIALS AND BLOOD Biomaterials used in medical devices are likely to interact with blood first, this interaction is in itself highly complex. When blood interacts with foreign surfaces it triggers a complex series of events. These include protein adsorption, platelet activation and adhesion, coagulation, and thrombosis. The plasma proteins adsorb onto the surface which leads to activation of the blood and subsequent biological responses such as thrombus formation. Thrombus formation is a major problem in the development of long-term, blood contacting devices. A specific example being catheter thrombosis which can be seen in various forms. These forms of thrombosis account for up to 40% of catheter failures, which interrupts strict dialysis schedules, reduces flow rates of catheters, and results in the use of costly measures. Temporary treatments can be used; however, viable long-term options are required.
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BIOMATERIALS AND PROTEINS Biomaterials interact with blood and its hundreds of proteins, through a wide range of biological functions which are present in significantly different concentrations. Thrombosis is a critical obstacle faced by devices and is impacted by the activity of fibrinogen, fibronectin, vitronectin and von Willebrand factors (vWF).
Proteins themselves, are one of several different factors known to influence the composition, adsorption, structure, and function of proteins. These surface properties include surface free energy and wettability, surface topography and roughness as well as the surface chemistry and functional groups. Protein adsorption which leads to thrombus formation, is an energy-driven process which involves the traits of both proteins and substrates involved. Correlations have been reported between the amount of protein adsorbed on polymeric materials and total surface energy of the substrate. Furthermore, surface wettability is a crucial factor in determining the adsorption of proteins on a surface. This is another contributing factor to determining the adhesion of proteins on a surface. Hydrophobic surfaces tend to adsorb larger amounts of proteins compared to hydrophilic surfaces. This is due to the hydrophilic surface being strongly bound with water molecules which are difficult for proteins to displace. There are a wide variety of complex factors which play an important role in the biocompatibility of a surface. The interactions mentioned above are only a few of the many complications seen when biomaterials are used within the human body. The challenges and the biological responses are influenced by critical factors such as surface chemistry, surface energy and surface topography. The biological events which occur on a surface are a complex result of interactions between the surface and the proteins and cells which are present at the device-body interface. These complex challenges require a straightforward, multi-phase material which considers all these varying factors in one technology. Multi-phase materials provide a highperformance surface which prevent biological responses, enhance device performance, reduce complications to the user (surgeon) and improve patient well-being, in one straightforward solution.
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COVER STORY
STRAIGHTFORWARD SOLUTIONS MULTI-PHASE COATINGS: A STRAIGHTFORWARD, HIGH-PERFORMANCE SOLUTION BioInteractions innovates high-performance, multi-phase biocompatible coatings which actively confront the varying and complex biocompatible challenges of medical device surfaces. Our 30 years of research and development, has resulted in a range of proprietary polymer coatings which targets and prevents complex biocompatible challenges. Our coatings enhance medical device performance, improve the usability for the user (surgeon), and reduce patients’ risks and complications throughout the therapy.
Astute Active Antithrombogenic Coating prevents thrombosis formation using a high-performance, multi-phased solution. The coating technology uses an active antithrombogenic agent combined with additional passive elements to provide a highly effective, nonleaching antithrombogenic coating. The active component actively stops blood activation and prevents a thrombus from forming downstream in a patient. The passive elements electrostatically and physically prevent the various proteins in blood from interacting and adsorbing onto the device surface. This multi-phased solution mimics the endothelial layer to improve biocompatibility in longterm applications. The coating ensures a high-performance and high-quality surface. The Astute Antithrombogenic Coating provides a highly biocompatible surface that actively stops thrombus formation whilst protecting the surface and improving laminar flow. BioInteractions innovates and manufactures all our coating technology in house, as well as provides customer focused services. We combined our innovative, multiphase technology with our expertise to help our partners through the development process and provide a high quality, all-in-one coating experience.
Astute Antithrombogenic Coating prevents thrombosis formation using a high-performance, multi-phased solution.
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NEW DATES
88%
of exhibitors said they made a sale directly related to Interplas.
92%
of visitors found a new supplier or technology they has not known of before.
Exhibit with us Interplas is back in 2021, bringing with it the opportunity for you to experience the UK’s largest plastics industry exhibition showcasing the full spectrum of plastics processing machinery, materials, software, services and ancillaries in one place. It’s also the only plastics event in the UK where visitors can see working machinery LIVE on the show floor and where they’ll come to compare, contrast and buy. With an expected 14,000+ attendees across the three-day event, as well as new features and an expanded floorplan, now is the time to position yourself as a company that can offer solutions, showcase innovation and offer expertise to an audience known for its quality and purchasing power.
@InterplasUK #InterplasUK www.interplasuk.com
Co-located Shows
COATINGS
PROF. ANGEL PORGADOR, FROM THE DEPARTMENT OF MICROBIOLOGY, IMMUNOLOGY AND GENETICS AT BEN-GURION UNIVERSITY (BGU) AND THE NATIONAL INSTITUTE OF BIOTECHNOLOGY IN THE NEGEV (NIBN), AND DR. MARK SCHVARTZMAN, FROM THE DEPARTMENT OF MATERIALS ENGINEERING AT BGU, EXPLAINS HOW THEY ARE DEVELOPING A COATING EFFECTIVE AGAINST COVID-19.
The journey C
ertain metals which are not poisonous to humans, can be lethal even in small quantities for viruses and bacteria. Therefore, in proof of concept experiments, we assessed the effect of surfaces coated with nanoparticles of various metals on the infectivity of lentiviruses, which belong to the HIV family in human cells. The findings showed that surfaces coated with copper nanoparticles are able to strongly block the infection of the cells by the virus. We believe that these ongoing experiments show a huge potential for copper ions in preventing surface-mediated infection with SARS-CoV-2.
In terms of challenges surrounding this research, the main challenge is to find the optimal formulation of the polymer with the embedded nanoparticles of different metals, which would provide the most effective elimination of the coronavirus on the surface.
Following these findings, we are developing anti-viral coatings that can be painted or sprayed on surfaces. The coatings are based on polymers, which are the starting materials of plastics and paints, and contain nanoparticles of copper and other metals. The polymers serve as binders, e.g. a matrix material in which the active component - metal nanoparticles - are embedded.
Additionally, viruses are all different from each other by their size, structure, properties, as well as the way in which they interact with the environment. Therefore, nanoparticles of different size and chemical composition release active ions that interact with each type of virus through different pathways. This means that it is possible to optimize a nanoparticle based coating for one specific virus but formulating a coating that would satisfy multiple requirements stemming from diverse characteristics of different viruses is more challenging.
The nanoparticles embedded in the polymer will then enable the controlled release of metal ions on to the coated surface. This is because studies show that these ions have a strong anti-viral effect, which can eradicate virus particles that adhere to the surface. The release of ions is extremely slow, and so the coating can be effective for a long period of time - weeks and even months, reducing the infectivity of the virus particles by more than ten-fold. This research activity is part of the coronavirus research task force, founded by Prof. Daniel Chamovitz, president of BGU. The research began when research funds were diverted in order to find rapid solutions for various challenges associated with the coronavirus pandemic. This invention also received the support of the Israel Innovation Authority.
Another key challenge relates to the polymers used for the coatings. Polymers are required to provide strong adhesion to the surface the coating is applied on, and the ability to adhere depends on both the polymer and surface. This is why specific glues are used for different surfaces, and it is important to formulate a polymeric system which will universally stick to all surfaces. Although the current research is focused on the coronavirus, we believe that since the mechanism behind the bioactivity of metal ions is universal, the developed coating will be effective against most viruses and bacteria. Where is the research up to now? Currently, it is in the stage of transferring from a working prototype to a consumable product.
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JENNIFER RITER, SENIOR DIRECTOR, ANALYTICAL SERVICES FOR WEST PHARMACEUTICAL SERVICES, EXPLORES THE IMPACT OF EXTRACTABLES AND LEACHABLES ON COMBINATION PRODUCT DEVELOPMENT.
A MATCH
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made in heaven
xtractables and leachables analysis is an essential and integral part of qualifying combination product packaging and delivery systems during drug development. With combination products, there are typically multiple elements that comprise the device and/or packaging - and all must be meticulously studied to ensure compliance with regulations requiring sufficient data and information to prove that the packaging system chosen maintains the quality, sterility and efficacy of the product. Plastic materials are commonly utilized in combination products from different parts that come into contact with the drug product, such as tubing or other fluid paths, to incorporating a primary packaging containment system into a device.
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defined as organic and inorganic chemical entities that are released from a pharmaceutical packaging/delivery system and into an extraction solvent under laboratory conditions. Extractables themselves, or substances derived from extractables, have the potential to leach into the drug product and thus become leachables. Leachables are defined as organic and inorganic chemical entities that are present in a packaged drug product because they have migrated into the packaged drug product from a packaging/delivery system, packaging component, or packaging material of construction under standard conditions of storage and use or during drug product stability studies. This means that the leachables ultimately can then reach the patient. Leachables can be of little or great consequence, so it is critically important to have a thorough understanding of what may be present in a drug prior to it being administered.
DEFINITIONS, DIFFERENCES AND CORRELATIONS It is important to discern the definitions of extractables and leachables, as well as the relationship between the two. Extractables are
KEY SOURCES There are different sources of extractables and leachables that need to be considered and evaluated. In general, sources of extractables can include plastics as well as glass, paper, adhesives, and inks. In addition to the primary packaging materials, the secondary packaging materials, interim storage containers and processing equipment may also need to be evaluated for compounds that may leach into the drug product.
Proper evaluation, studies, and analysis of extractables and leachables serve an essential function during drug and device development.
For example, an advanced polymer vial container or pre-filled syringe system that utilizes a Cyclic Olefin Polymer (COP) or Cyclic Olefin Copolymer (COC), which is a semi-permeable material, may need to be evaluated when a label is applied. Adhesives and inks on the label contain compounds that can migrate through the polymer and
EXTRACTABLES AND LEACHABLES leach into the drug product over time. As for interim storage containers of Active Pharmaceutical Ingredients (API), drug substance, or drug product, these may need to be considered for extractables and leachables analysis due to contact with products over a prolonged period, prior to final packaging. IMPACT OF ASSESSING AND TESTING Proper evaluation, studies, and analysis of extractables and leachables serve an essential function during drug and device development. This includes: • Characterizing packaging and delivery system components and materials of construction • Facilitating the selection of components and materials • Enhancing an understanding of the effects of manufacturing processes like sterilization • Establishing the worst-case potential leachables profile in a manner which facilitates leachables studies • Confirming qualitative and quantitative leachables–extractables correlations • Facilitating investigations to the origin of an identified leachable • Assessing patient exposure to chemical entities A combination product example may be cartridges, which would be considered the primary containment system for the drug product which may then go into an on-body injection device. The process of determining an appropriate approach for extractables and leachables testing for a complex combination product like a cartridge begins with an extractable assessment to understand and ensure all materials are characterized appropriately, which in turn reveals what can extract or come out of any given material in general. This means characterizing every material that comes into contact with the drug e.g. glass cartridge, rubber plunger, plastic cartridge, and plastic tubing, as it carries the drug product from the primary packaging container and device into the patient. For on-body combination products, not only would the primary containment system need to be evaluated, but also plastic tubing needs to be carefully considered when conducting such studies. A good example of this is our SmartDose injector - a wearable, subcutaneous injector with an integrated drug delivery system that delivers a truly patient-centric approach to self-administration. In addition, a pharmaceutical manufacturer may label the plastic cartridge holding a primary drug with an expiration date and shelf life information. If so, the label, its adhesive, and the ink used, need to be studied because elements of these may migrate into the drug over time - it is just a matter of how much and how long it will take. Such migrational tendencies will change depending on exactly what is packaged, and how much it will extract from that containment system over time, so it’s important to evaluate each containment system and each material appropriately, and characterize it upfront in order to fully understand what may potentially leach into the product over time. Leachables, as a subset of extractables, should then
be evaluated to further determine what, under normal shelf-life conditions, will potentially come out of a material such as plastic and get into the drug product over time. While not every extractable will leach into a drug product, manufacturers must carefully evaluate the compatibility of the drug and packaging/device materials in order to calculate risk and optimize both safety and efficacy. CONCLUSION It is well-established that combination product materials contain extractables that can leach into drug products and may significantly impact development processes. Nothing is without extractables - every material has the propensity to extract and contains compounds that will leach into the drug over time. As plastic is semi-permeable, it has the potential to be more susceptible to the migration of adhesives and inks from labels into a drug during long-term storage. To ensure proper evaluation and understanding of this, a collaborative process can be helpful. For instance, when conducting a migration study on a semi-permeable packaging product and its labels, it can be beneficial to work closely with the label manufacturer in order to fully understand what the material profile may be of the label material and adhesive. Extractables and leachables can be most effectively managed through timely and meticulous evaluation and testing, as well as knowing what to look for and examine. The list of factors to consider and evaluate can be complex in order to be truly comprehensive and create a complete and holistic approach. It begins in the concept and planning stages and continues through production, shipping, storage, and delivery/administration - and must factor in primary packaging and the device, as well as secondary and tertiary packaging every step of the way. Extractables and leachables cannot be fully mitigated, but the risks and challenges can be minimized when a complete understanding and analysis of the material(s) being used is ascertained.
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ROBOTS AND AUTOMATION
MPN EDITOR LAURA HUGHES REACHED OUT TO SCOTT MARSIC, SENIOR PRODUCT MANAGER AT EPSON ROBOTS, TO FIND OUT WHY MANUFACTURERS WITHIN THE SECTOR ARE INCREASINGLY TURNING TOWARDS AUTOMATION.
Please can you tell us about the two types of robots Epson has, and how the two differ? SCARA and 6-Axis robots together make up the bulk of industrial robot placements in the Americas - upwards of 80% (Fuji Keizai 2020), and for the past eight years, Epson has been the worldwide market share leader for SCARA unit placements, a position that the company still retains today.
it to do and respond to whatever inputs you give it access to. If you program a robot to pick up a hearing aid part, you need to tell the robot where the part is located, how to grab the tool, and what to do with it. An integrated vision system often acts as the "eyes" of the automation system. With vision a robot can now "look" for the part, interpret its position, and move to the correct location for manipulation.
SCARA robots became well known in industrial automation for their fast, high precision and high repeatability assembly, pick and place and packaging capabilities. In the medical sector, SCARA robots are frequently used when speed and precision are vital to the manufacturing process e.g. pacemakers, hearing aids, etc.
What are the main trends you are seeing within the robots and automation industry at the moment? As robots advance to make more intelligent and dynamic decisions, they increasingly require the use of more sensors and computing power to process input data. For example, advances in sensor integration with artificial intelligence will drive performance advancements, allowing robots to be more efficient and better handle manufacturing exceptions.
6-Axis robots are designed for applications that require increased dexterity of motion usually related to orientation of the wrist axes. These robots are great for a wide range of activities such as extracting plastic parts for a medical device from an injection molding machine or manipulating blood testing equipment for inspection and packaging. During our meeting in MD&M West, I was informed about the option of an add-on feature to the robots such as a vision system. How much difference does this make to the testing and inspection process? A robot is a tool that is going to do what you tell
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Parts inspection is also a key component to the manufacturing process. An extruded plastic part for a medical device might contain residual burrs or flash that need to be removed. A vision system can help efficiently identify these features for removal, and then provide a quality check afterwards to assure the product meets the final production requirements.
Another trend is helping factories to understand the health of automation equipment, including robots. If factory managers can better understand potential robot issues such as remaining motor live in advance of an actual failure, this can represent big gains in terms of reducing downtime and lost productivity. How do you see the sector transforming within the next five years? Even before Covid-19, manufacturers were increasingly turning towards automation in response to a decreased availability of skilled workers and increases in product complexity. Companies like Epson are well poised to help customers looking to venture into automation by offering reliable, affordable, and easyto-use robotic solutions. Covid-19 has accelerated this movement by making companies acutely aware of their need for an automated manufacturing base that is always available and always running. A recent survey from Pod Group showed that almost threequarters of business leaders across multiple sectors expect automation to speed up in the wake of the pandemic. WWW.MEDICALPLASTICSNEWS.COM
INTERNET OF THINGS
ROHINI CHOUDHARY FROM TRANSPARENCY MARKET RESEARCH CONDUCTS A SWOT ANALYSIS OF THE INTERNET OF THINGS (IOT) MEDICAL DEVICES WITHIN THE HEALTHCARE SECTOR.
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IOT: A SWOT ANALYSIS
echnology has transformed almost every sector around the universe. Bill Gates once rightly said, “the advance of technology is based on making it fit in so that you don't really even notice it, so it's part of everyday life.” Technology is, undoubtedly, an important component of every individual’s life. The waves of technology have reached the shore of every sector efficiently and are serving the prospective sectors in the best possible way. The healthcare sector is no exception. Technology has taken quantum leaps in the healthcare industry. A Deloitte report highlights the availability of more than 50,000 medical technologies. These statistics represent the thriving technology arm of the healthcare sector. The IoT is a prominent type of technology that has blossomed well in the healthcare industry. The proliferating use of the IoTs in the medical industry has raised the bar of the quality provided in every medical application. STRENGTHS The strengths of IoT medical devices are associated advantages such as decline in operational costs, improved drug management, and minimal errors. These strokes paint a positive picture of growth across the canvas of the IoT medical devices market. Increased funding from various sources is helping the IoT medical devices market to thrive largely and are adding strength to the growth. Easy data collection, remote patient monitoring, and maintenance of assets are serving as glowing stars of growth for the IoT medical device market. Additionally, partnerships for developing cutting-edge IoT medical devices are serving as a gold standard for growth, and evolving technologies such as hearables, wearables, ingestible sensors, moodables, and computer vision technology are bringing exponential growth for the IoT medical devices market.
WEAKNESSES Devices produced by different manufacturers do not work together in a great way. This factor limits the potential and effectiveness of IoT medical devices, thus dampening the growth prospects. The high cost is also a negative aspect that hinders the growth of IoT medical devices. The implementation and staff training costs are also very high. Furthermore, bugs in the hardware can be perilous for the growth of the IoT medical devices market. OPPORTUNITIES The Covid-19 outbreak has crippled the world with high transmission rates and fatalities. In these unprecedented times, the IoT medical devices are advancing rapidly due to their growing usage. This outbreak can serve as a good opportunity for IoT medical devices to grow. The use of connected thermometers, wearables, and mobile applications to track the Covid-19 outbreak is proving to be a boon for the IoT in the healthcare sector. The setting up of smart hospitals may also bring great opportunities for implementing IoT medical devices. THREATS Numerous threats are associated with IoT, with hacking and data-stealing being the prime ones. These threats can largely impact the growth of IoT in the healthcare sector. For instance, several IoT medical devices were negatively impacted by Ripple20 vulnerabilities recently. These vulnerabilities can allow an attacker to steal data and also impact the functioning of connected medical devices.
REFERENCES
https://www.transparencymarketresearch.com/iot-medical-devices-market.html
CONCLUSION Nevertheless, IoT in the healthcare sector displays a bright picture of growth despite several downsides and will continue to transform the healthcare industry greatly in the near future.
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THE LEADING VOICE IN POLYMER INNOVATION FOR THE MEDICAL DEVICE SECTOR Medical Plastics News provides essential information on materials and engineering processes for anyone involved in the design, supply and manufacture of plastic medical devices.
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DESIGNING MEDICAL COMPONENTS
CLINT D. BADOWSKI, PRODUCT ENGINEER AT CAPLUGS, LISTS THREE TOPICS TO DISCUSS IN DETAIL WHEN QUOTING A NEW MEDICAL COMPONENT.
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hile there are no guarantees on what vendors are going to ask during the initial design review for quoting, there are some general topics you should be ready to discuss in more detail about your medical plastic component(s) during this interaction to make the process as smooth and as productive as possible. There are general topics that are covered for all plastic components when being reviewed for a quote such as annual volume, critical dimensions, material choice, gating requirements, and quality requirements. When it comes to medical plastic components, some of these topics will need to be discussed in more detail and there could be additional topics that could/should be discussed as outlined below. MANUFACTURING Does the product have a medical class it must meet? Class I, II, IIb, and III have different requirements for production, quality methodology, process documentation and traceability, process controls, audits, corrective action procedures, preventative action operations, etc. Does the vendor have the capability and a thorough understanding of the classification to handle the production of this component? Does it have to be produced in a specific class of cleanroom or is normal floor molding ok? This may affect capacity, cavitation, quality plan, parts handling, or even if the vendor can produce the part. DESIGN AND USE The part design and where the part is used can have a huge effect on tool design. Will the product be used while medical personnel are wearing medical gloves? If so, this could greatly change the approach to gating style and location, parting line location, part orientation in the tool, etc. Does the part have requirements with ergonomics? Is there an area of the part that will be held in a user’s hand that will require the area to be clean of burrs and parting lines or require a specific texture? These could also change the approach to the tool design affecting cost and lead time. MATERIAL Do the parts have to be sterilized post molding at any stage of their life cycle? Is the part going to be reusable? Does the part encounter uncommon chemicals? Does the product require the use of a material that meets specific regulations such as FDA approved or medical grade? All these things will come into consideration when choosing a material suitable for the part and application. Are there specific features in the design that could affect material choice? Are there areas that require little to no draft? This could require a material to be selected
with a higher modulus so the parts can be ejected. Is there a specific surface finish required? This could require a material that can reach the surface finish. Is over-molding going to be used? The compatibility of the two materials would have to be considered. These scenarios would also affect the tool design and layout. CONCLUSION Overall, medical components are more complicated for vendors to quote. These three topics are just a few that will be mentioned during conversations about a medical component when discussing the quoting of your product with a potential vendor. If these types of topics and conversations are not being brought up, there should be some concern about the vendor’s knowledge and capabilities to produce medical components. The more information that you can bring to the table, the easier and more effective the whole process will be for both sides.
THINGS YOU SHOULD KNOW
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KEEPING UP WITH TOM HOOVER, SENIOR MEDICAL BUSINESS DEVELOPMENT MANAGER - AMERICAS, ASSEMBLY TECHNOLOGIES AT EMERSON, HIGHLIGHTS THE LATEST ADVANCES IN ULTRASONIC WELDING AND EXPLORES HOW TO MEET THE DEMANDS OF THE MEDICAL DEVICE SECTOR.
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he latest advances in ultrasonic welding for medical devices are driven by the need to assemble plastic parts that tend to be smaller and lighter in weight, thinnerwalled, and often more contoured than in the past. A growing number of these parts also contain embedded electronics and sensors that require special care in the ultrasonic welding process.
Meeting the medical device industry’s demand for repeatable, strong and consistent welds in these smaller and more delicate components has required the development of improved ultrasonic welding technology. Perhaps the most important recent improvement has been the development of new, more precise methods of force control. This has required a series of changes to the ultrasonic welding actuator and its microprocessor controls. To achieve the greater and more precise levels of force control required, the developers of Branson ultrasonic welding technology considered not only the capabilities of pneumatic actuators - which remain an industry standard - but also the rapidly advancing capabilities of servo control and technology. Their solution was a new electromechanical actuation system, recently introduced in Branson GSX welders from Emerson. A key attribute of this new welding platform and its advanced actuation system is substantially more precise and responsive force control through the entire weld process. Downforce is necessary to maintain horn/part contact and ensure the smooth, efficient transmission of ultrasonic energy into the mating parts. Managing downforce more rapidly and precisely has important implications for weld quality. THE ROLE OF WELD FORCE CONTROL For a given set of weld parameters, variations in force control that result in applying too little force reduce compression of the mating surfaces, reduce the heat generation needed for plastic melt, and result in cold or weaker welds. Similarly, force variations that result in applying too much force can cause part joints or energy directors to deform, deflect or break and may not provide enough time for proper melt flow and polymer entanglement to occur.
Applying just the right amount of force at just the right time results in quality welds with highly consistent characteristics and strength.
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Applying just the right amount of force at just the right time results in quality welds with highly consistent characteristics and strength. Ideal force control requires rapid, dynamic changes in the clamp force/ downspeed applied by the actuator following the melt of the plastic. This adjustment, called ‘dynamic follow through,’ enables each weld cycle to adapt to part-topart variances and other factors such as the type of plastic, joint style, and part geometry.
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DEMAND As the speed and precision of force control and dynamic follow-through increase, the strength, quality and consistency of plastic welds follow. For example, the strongest ‘pull force’ for a part weld results from a controlled force profile that allows for complete and random polymer chain entanglement that makes the weld as strong as the parent material (as shown in figure 1). Cold Weld
Weak Weld
Strong Weld
No entanglement
Partial parallel entanglement
Complete entanglement
Polymer Chains
JOINING TECHNOLOGIES
More consistent and complete polymer chain entanglement and stronger welds are a direct result of technical improvements in force control. By evening out even small force variations very quickly, the process control and actuator in the GSX welder maintain more consistent horn-to-part contact and enable weld parameters to be executed far more accurately and gently. So, for even hard-to-weld shapes and small or delicate parts, it can provide superior weld quality and improved yields, characterized by uniform and consistent weld collapse depths, with minimal flash or part marking. RESULTS OF IMPROVED FORCE CONTROL In a series of laboratory tests and and customer trials, the advanced process controls and electromechanical actuator in the GSX-E1 welder reportedly consistently outperformed pneumatically actuated welders, enabling the latest ultrasonic welding platform to: • Produce welded parts with more consistent and repeatable levels of strength. • Change downforce on a weld within milliseconds as part-to-part melt occurred, resulting in more precise closed loop control over heat generation and dissipation, weld-collapse depth, and weld quality. • GSX-E1 repeatability across multiple welders. • Complete challenging part welds with exceptional consistency. In another example, this time involving far-field welds of a long, thin (0.070” wall thickness) tube with a shear joint into a molded base, a customer was able to produce strong welds with its legacy welder, but sometimes had quality problems including part marking and inconsistent weld depth, resulting in flashing. A weld trial set up in less than fifteen minutes with the new intuitive Branson GSX quickly resolved the problems. Its responsive process control and electromechanical actuator delivered weld amplitude consistently and smoothly, resulting in parts free of markings and flash with higher average pull strength.
Bond Line
Figure 1: Polymer chains in cold, weak, and strong welds. Emerson ©
As seen in the right-most illustration in Figure 1, ideal force control adjusts downforce milliseconds after the melt, allowing polymer chains to extend vertically across the part interface and entangle with each other across the bond line as melt and compression occur before cooling. By contrast, weaker welds, characterized by partial or no polymer chain entanglement, show polymer chains that reassemble parallel to the bond line without entangling across the part interface. The centre weld shows the impact of inadequate force control, while the ‘cold’ weld at left could be caused by too little or too much downforce in too short a weld time.
The improved force control capabilities built into the new GSX ultrasonic welding platform from Emerson typically enable GSX welders to produce these and similar results while reducing weld cycle time, peak power input, and total weld energy consumption compared to other welders. Emerson ©
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ADHESIVES
NEAL CARTY, BUSINESS DIRECTOR, NORTH AMERICA, AND SENIOR DIRECTOR, GLOBAL R&D, AVERY DENNISON MEDICAL, DESCRIBES THE ROLE OF SKIN-FRIENDLY ADHESIVE IN A NEW TYPE OF N95 FILTERING FACEPIECE RESPIRATOR (FFR).
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one of the “Ps” in Personal Protective Equipment (PPE) are supposed to stand for “pain,” but unfortunately that is exactly what some N95 FFRs are causing for many healthcare professionals. Nurses, physicians and other providers have reported rashes and other skin trauma following long wear times in tightfitting N95 half-mask FFRs.
The medical device industry is working to offer healthcare professionals better PPE options.
Anatomy of a novel adhesive tape. Avery Dennison Medical ©
As the medical device industry responds to PPE requirements, and healthcare institutions look to build up better stockpiles, new approaches to FFRs promise to offer clinicians greater choice and comfort. One such development is an N95 FFR that adheres directly to the user’s face. This design eliminates the need for elastic bands to pull the device against the face. Instead, the respirator conforms to the face of each individual end user, secured around the nose and mouth with a skin-friendly adhesive. For any N95 FFR to properly protect the wearer, there can be no leakage around the edge of the respirator. To be certified by the National Institute for Occupational Safety and Health (NIOSH), these respirators must be proven to offer protection from particulate materials, including common bacteria and submicron particles, with at least 95 percent efficiency. For a self-adhesive N95 FFR, it is critical for the adhesive system to provide an effective seal boundary. The right double-coated adhesive tape enables this seal integrity. One side of the tape carries an aggressive adhesive designed to irreversibly bond to the FFR filtering material, typically a polypropylene Spunbond Meltblown Spunbond (SMS) nonwoven. The other side carries a gentle adhesive designed to adhere the FFR to the wearer’s skin, where it can remain comfortably and securely in place for several hours, if needed. Of course, with PPE, what goes on must come off. When the user is finished with the FFR, he or she must be able to remove it easily, with minimal discomfort. The skin-facing adhesive used in the FFR must offer gentle peel adhesion for atraumatic removal.
This type of N95 FFR secures to the wearer’s face with a skin-friendly acrylic adhesive. Avery Dennison Medical ©
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In conclusion, the medical device industry is working to offer healthcare professionals better PPE options. Skin-friendly adhesives play a key role in half-mask N95 FFRs that create a gentle but secure protective boundary on the user’s face.
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BIOMEDevice Boston: In brief 1
The expo which was originally planned for 16th17th September 2020, will now take place from 5th-6th May 2021.
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The event will be held at the Boston Convention & Exhibition Center in Boston, MA.
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The event is aimed at researchers and developers, engineers, executives, owners and designers.
Could virtual reality help restore vision for stroke-induced blindness?
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esearchers from Rochester Institute of Technology and the University of Rochester have received a grant from the National Institutes of Health to develop the promising method. There isn’t currently thought to be any well-established Sue Weisler ©
therapies to help stroke patients restore their vision. Research by Krystel Huxlin from the University of Rochester’s Flaum Eye Institute found that patients can regain portions of their vision through targeted exercises that force them to use the blind portions of their visual field. Therefore, this research aims to build on Huxlin’s. Gabriel Diaz, the principal investigator of the grant, said: “One major limitation of the current methodology is that people cannot train as effectively at home if they’re not under the supervision of a researcher who’s using an eye tracker. Eye trackers are an emerging technology in the field of virtual reality and we’re going to develop a training apparatus that could be used at home.”
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At the show, attendees will be able to source experts in 3D printing, product design and development, contract manufacturing, biomaterials and medical device components.
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Why Boston? The region is a leader in medtech innovation, with 25% of exports from Massachusetts being for medical devices.
Plastic membrane could be used as a treatment for AMD
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ge-related Macular Degeneration (AMD) is a common condition that typically first affects people who are in their 50s and 60s. Although the indication doesn’t cause total blindness, it affects the middle part of your vision and can make everyday tasks difficult. Bruch’s membrane is the innermost layer of the choroid, and researchers from the PSG College of Technology in Coimbatore, Tamilnadu, India, have designed a prosthetic
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Bruch’s membrane, based on porous PolyCaproLactone (PCL). The researchers concluded: “The results show that the scaffold with higher porosity has a lower pressure gradient which is necessary for retinal pigment epithelial adherence and is mechanically stable. This proves that a PCL scaffold with higher porosity is a potential replacement for Bruch’s membrane.” The work is published in the International Journal of Biomedical Engineering and Technology.
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