NORTH AMERIC AN EDITION
MEDICAL PLASTICS news +
MD&M EAST PREVIEW INNOVATION IN IMPLANTS HOW RIGHTPOINT'S NEW APP IS IMPROVING COMMUNICATION
ACCUMOLD TALKS ULTRA-THIN WALLED MICRO MOLDING ISSUE 10
Apr/May/Jun 2019
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ADVANCING MEDICAL PLASTICS
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ORTHOPAEDICS DENTAL VASCULAR
CONTENTS MPN North America | Issue 10 | Apr/May/Jun 2019
Regulars
Features
3 Comment Laura Hughes discusses respect around regulations
9 Breaking the mold Moldworx presents a unique and improved manufacturing solution
4 News focus 6 Digital spy 12 Cover story Accumold highlights trends towards ultra-thin walled micro molding as well as electronics 40 Back to the future
15 An international launch Angelo Gentile describes how company leaders hope to launch the Quantra System in the US 18 What’s on at MD&M East? Discover more about the event set to take place in June this year
25 Location, location, location Dave Gray spoke to Michael Faulkner to discuss the new plastics manufacturing facility 33 Demanding designs Compounding Solutions highlights technologies such as ReZilok 35 Getting personal Rightpoint discusses the launch of its new app with GenerationOne
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CREDITS
EDITOR’S
editor | laura hughes laura.hughes@rapidnews.com
comment
group editor | dave gray 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 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 FREE on iOS and Android devices Subscription enquiries to subscriptions@rapidnews.com Medical Plastics News is published by: Rapid Life Sciences Ltd, Carlton House, Sandpiper Way, Chester Business Park, Chester, CH4 9QE T: +44(0)1244 680222 F: +44(0)1244 671074 © 2019 Rapid Life Sciences Ltd While every attempt has been made to ensure that the information contained within this publication is accurate the publisher accepts no liability for information published in error, or for views expressed. All rights for Medical Plastics News are reserved. Reproduction in whole or in part without prior written permission from the publisher is strictly prohibited.
ISSN No:
2632 - 3818 (Print) 2632 - 3826 (Digital)
Respect for regulations: How can we ensure this?
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ecently, The National Institute for Health and Care Excellence (NICE) has published updated guidelines that include the use of the controversial, surgical vaginal mesh implant. The publication of these guidelines has attracted mass media attention and disappointment amongst campaigners and people who have previously experienced negative consequences as a result of having the implant. The announcement of these guidelines comes at a time where the regulations surrounding some medical devices are being tightened. I believe this is partly due to the wide portrayal of this field in the media via online articles and through documentaries on platforms such as Netflix. Following this coverage, I think lay people are beginning to question certain regulations and approvals practiced by medical professionals. I find it really interesting to compare the various regulations surrounding the two very different fields of medical drugs and devices. Medical drug and device regulations are thought to be highly regarded and respected by medical professionals, as well as the general public. The difference it can mean for a device to be certified by a regulatory body is highlighted on page 35 of this issue. This article discusses how Rightpoint, an independent customer experience agency, has recently announced the formalization of its healthcare practice, as well as a new medical software certification, which will enable the company to deliver the Food and Drug Administration (FDA)approved medical grade software. Rightpoint believes this will be hugely advantageous to the company commercially. However, programs such as the FDA’s Breakthrough Devices Program raise a lot of questions. The FDA aims to rapidly approve some devices through this program, which was launched in 2016. For standard practice, the process can take as little as three years to bring a device to market, which is significantly less than the process of bringing a drug to market, which on average can take 12 years. However, time does not always define the success and safety of a new process or product. WWW.MEDICALPLASTICSNEWS.COM
Most people will be aware of drugs such as thalidomide, which caused life-changing side effects and even resulted in death in some cases. I think the FDA’s overhaul of its regulations, which was announced late last year, will help to instill respect and trust in our regulations and regulatory procedures, within the general public and healthcare professionals, who may have previously had their doubts. The ever-growing presence of social media enables the patient’s voice to be heard and allows constant questions to be raised by experts and non-experts alike. The option for the patient to make the choice and be in control is clear within the updated mesh implant guidelines, and may be something that is to be incorporated in to many other future guidelines.
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I think lay people are beginning to question certain regulations and approvals used by medical professionals in practice. 3
NEWS FOCUS
A new framework for artificial intelligence-based medical devices THE FOOD AND DRUG ADMINISTRATION (FDA) HAS RELEASED A WHITE PAPER OUTLINING A POTENTIAL REGULATORY FRAMEWORK FOR SOFTWARE AS A MEDICAL DEVICE (SAMD) THAT LEVERAGES ARTIFICIAL INTELLIGENCE (AI) OR MACHINE LEARNING (ML).
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s the FDA has acknowledged, AI products with algorithms that continually adapt based on new data are not well suited to the current guidelines under which significant software modifications require a new premarket submission prior to marketing. Therefore, the FDA has released a white paper that highlights the challenges that AI/ML-based software poses to the traditional medical device regulatory framework. The white paper also considers the agency’s Software Pre-Certification Program and applying a regulatory approach toward a product’s entire life cycle. It is hoped that this framework will help to promote the development of ML devices and programs. Scott Gottlieb, FDA commissioner said in an agency statement, “as technology and science advance, we can expect to see earlier disease detection, more accurate diagnosis, more targeted therapies and significant improvements in personalized medicine. “A new approach to these technologies would address the need for the algorithms to learn and adapt when used in the real world.”
Last year, the FDA approved an AI algorithm for the early detection of diabetic retinopathy. The system developed by manufacturer IDx aims to help primary care clinics screen their diabetes patients without the need for a specialist. According to the FDA, this device is classed as a “locked” algorithm which is dependent on updates from the manufacturer. This means things such as new training data would require manual validation. Gottlieb stated, “there’s a great deal of promise beyond locked algorithms that’s ripe for application in the health care space, and which requires careful oversight to ensure the benefits of these advanced technologies outweigh the risks to patients.” Eric Topol, founder and director at Scripps Research said how he thought the white paper, “demonstrates careful forethought about the field.”
A new approach to these technologies would address the need for the algorithms to learn and adapt when used in the real world.” 4
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DIGITAL
MATERIAL UPDATE
spy
Could a new formation be advantageous for bone tissue scaffolds?
TECHNOLOGY UPDATE
www.butterflynetwork.com
scanning all over BUTTERFLY NETWORK RECEIVES CE MARK APPROVAL FOR BUTTERFLY IQ ULTRASOUND SYSTEM.
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utterfly Network, the US-based medical imaging devices manufacturer has made the first handled singleprobe whole body ultrasound system, which is now available for licensed medical professionals. The device, which has a built-in battery and wireless charging is designed to last for more than two hours of continuous scanning. There is also an application which is available online and for mobiles, and this allows users to organize and search studies on the Butterfly Cloud. All data is encrypted and access to the data is tightly monitored and secured by SOC II certification. Now, the Butterfly iQ has CE Mark and FDA 510(k) clearance for
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diagnostic imaging for 13 clinical indications, covered by 19 clinical presets which span the whole body; abdominal, cardiac adult, cardiac pediatric, carotid and arterial, fetal/ obstetric, gynecological, musculoskeletal (conventional), musculoskeletal (superficial), pediatric, peripheral vessel, procedural guidance, small organs (including thyroid) and urology. The Butterfly Network believe that the CE Mark approval for its device will really help to enable accessible and affordable medical imaging all around the world. They intend to start shipping Butterfly iQ to the international markets that accept CE Mark by summer 2019.
Researchers have evaluated the use of solvent-free polylactide/calcium carbonate for bone tissue scaffolds.
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ithin the 3D printing world tissue engineering is becoming increasingly used. A common challenge is the ability to heal bone defects and researchers are continuing to look for ways to achieve this. The idea of selective laser sintering (SLS) 3D printing for bioprinting remains of interest amongst scientists, but this often involves solvents. This technology is suitable for creating complex structures to encourage bone growth, with methods already being used
with both titanium and polyetherketoneketone (PEKK) implants which must stay in the patient’s body. Challenges exist when using solvents, as with polylactide (PLA) it only becomes soluble in organic solvents which are toxic. Additionally, the exposure to chemicals can cause future issues. There are however biodegradable and biocompatible options available. Researchers from Germany have looked at creating a PLA/ calcium carbonate composite powder for SLS. The team
experimented with four different composite powders and four different grades of PLA. PLA has the highest mechanical strength amongst the biodegradable polymers but it is quite brittle. Overall, researchers found that SLS test specimens demonstrated good cell compatibility with MG-63 osteoblast-like cells. Further in vitro and in vivo experiments are needed to evaluate the biocompatibility and degradation behavior of the developed materials and scaffolds.
DIGITAL UPDATE
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The safety of breast implants: Where does the FDA stand?
reast implantassociated anaplastic large cell lymphoma (BIA-ALCL) is the medical name for the cancer that individuals who have breast implants are at risk of developing. This is different to breast cancer and is a type of non-Hodgkin’s lymphoma (cancer of the immune system). By September 30th, 2018, 660 medical device reports were received by the FDA of people with BIA-ALCL, and nine of these people had passed away. The FDA held an advisory meeting on breast implant safety
in late March, during which recipients of breast augmentation or reconstruction called for a U.S. ban on textured implants. No formal decision was made though with expert advisers failing to come to a consensus on the next steps. However, in Australia it has been recently reported that regulators have made
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the decision not to ban any breast implant devices. They decided there was not enough information to ban any particular product at this time. In France the authorities have banned all macrotextured and polyurethane-coated implants. Whilst steps are also being taken in Canada where Health Canada have asked companies such as Allergan for more information on the safety evidence of the implants. The FDA plans to state the actions they will take in the next few weeks.
DIGITAL SPY
INDUSTRY UPDATE
talking
www.concertohealthai.com
POINT
Planning more precise cancer treatment options
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fizer and Concerto HealthAI have announced plans to work together to use real-world datasets and artificial intelligence (AI) techniques to develop novel, precise treatment options for patients with solid tumors and hematologic malignancies. A Concerto HealthAI-Pfizer joint steering committee will oversee the collaboration, and the first outcomes research is expected to be published in early 2020. “Pfizer believes real-world data have tremendous potential to inform how we develop and use medicines to improve patient outcomes”, said
Chris Boshoff, chief development officer, oncology, Pfizer global product development. Jeff Elton, CEO of Concerto HealthAI stated, “this collaboration aims to find and help patients who may benefit from new therapeutic combinations. We are using our definitive real-world data, AI-enabled abstraction, data science expertise, and strength in outcomes research to identify new and more precise treatment options; refine study designs; and speed up the completion times for various outcomes studies.”
Lighter, stronger and more flexible removable partial dentures einshaw, an additive manufacturing specialist and Egan Dental have joined forces to change the way removable partial dentures (RPDs) are designed and produced. Although 3D printing is well established within the dental industry it is typically resin based. This method utilizes metal additive manufacturing in the dental sphere by 3D printing RPDs, also known as chromes. Before 3D printing, the laboratory used processes that were not only more timeconsuming but also more prone to error. The challenges experienced with the previous processes can be addressed with additive
POCKET-SIZED POWER ILIKA, A SOLID-STATE BATTERY TECHNOLOGY SPECIALIST HAS ANNOUNCED THE LAUNCH OF STEREAX M50 BATTERIES.
HEALTHTECH UPDATE
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www.ilika.com
manufacturing. Together, Renishaw and Egan Dental Laboratory were able to develop a process suitable for producing every possible RPD. The solution established by the two companies begins with a technician drawing on the master model by hand and then 3D scanning the model to be converted into a CAD file. From there, the design is simply sent to the 3D printer. Renishaw’s laser powder ben fusion (LPBF) 3D printers are used as the additive manufacturing technology and are able to build the dentures up by melting 40-micron layers of cobalt chrome
powder. The process has resulted in dramatically faster production times as well as greater design flexibility. 3D printing has also enabled the production of RPDs that are lighter, stronger and more flexible than their traditional cast counterparts. These characteristics actually make the chromes more comfortable for patients. Further, the 3D printed RPDs have proven to be less prone to fracturing at the clasp, making maintenance easier for dentists.
WHAT IS THE STEREAX M50? Ilika’s smallest solid state battery designed for the needs of medtech. These batteries enable self-sustaining power sources that do not need to be changed regularly or use inconvenient cabling. WHY IS THERE A NEED FOR THIS DEVICE? As different devices require different sizes and form factors, customizable battery sizes and shapes such as the Stereax M50 are needed. WHAT ARE THE POTENTIAL APPLICATIONS FOR THESE BATTERIES? Stereax M50 batteries would be suitable for applications that require injection into the blood stream, monitoring heart rhythm or attachment onto the peripheral nervous system for neurostimulation. WHAT MAKES THESE BATTERIES DIFFERENT TO THOSE ON THE MARKET? They bring form factor choice enabling medical device innovations that have previously been limited by the available battery technology. WHAT ARE THE POTENTIAL ADVANTAGES OF USING THESE BATTERIES? Stereax M50 solid-state batteries have life spans up to 10 years and low leakage currents, making them suitable for low power wireless charging. Additionally, Stereax M50 has over 50% extra density compared to other solid-state batteries.
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Learn more at www.dow.com/medicalsolutions
CASE STUDY
BREAKING THE MOLD MOLDWORX A GILBERT, ARIZONA-BASED COMPANY WHICH SPECIALIZES IN PLASTIC INJECTION MOLDING PRESENTS A UNIQUE, IMPROVED MANUFACTURING SOLUTION FOR THE PRODUCTION OF MEDICAL DEVICES.
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oldworx who focus on designing solutions for medical device original equipment manufacturers (OEMs), were asked by a medical OEM to develop a single cavity injection mold to overmold a needle that is currently being glued in place. The overmolding process will automate the production of hypodermic needles, and as a result aim to reduce costs and improve productivity. In order to inject medical grade plastic around stainless steel needles as small as 0.012 in (0.305 mm), Moldworx managed to perfect the design and building of the molds, as well as the automation for this project. The first stage involved designing and developing an A-Series, single cavity injection mold with slides, with the needle being hand-loaded into the mold by an operator and then molded to a finished assembly to test the design. Commenting on the new process, Moldworx president Jim Taylor said, “this allowed us to overmold the needle eliminating a step in the current manufacturing process and reduce overall production time and cost.” The next stage was designing a production mold and automation that would robotically feed the needles into the mold cavity and eliminate the need for the operator.
Every stage of this process requires inspection and verification. To ensure process precision, the highest quality motors and controls are used in the automated cells. Following the success of the singlecavity mold, Moldworx have gone on to build a multi-cavity mold. This multi-cavity mold is able to quadruple the automated cell production, helping to increase the levels of production in order to meet high demands. “This is a prime example of the benefits of working with Moldworx,” claimed Taylor. “We partner with our clients to deliver innovative, automated plastic injection molding manufacturing solutions.”
Taylor explained, “we designed the mold to integrate with the automation and the automation to work in unison with the mold. In an effort to accelerate the timeline, the entire automation cell was built in parallel with the mold.” In order to separate thousands of bulk-packed delicate needles Moldworx designed a singulator. The singulator was developed with a hopper which enabled each needle to be introduced one at a time to the assembly line cell. A robot affixed to the injection molding machine then picks up each needle and indexes it in front of the high resolution cameras. This process ensures the needle tip will not be rejected due to damage. Once the needle is placed in to the mold, the mold then closes for the injection cycle. When the mold opens the robot removes the molded assembly and places a newly inspected needle into the mold. WWW.MEDICALPLASTICSNEWS.COM
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ORTHOPEDICS
JOINING THE DOTS MEDICAL PLASTICS NEWS GROUP EDITOR DAVE GRAY SAT DOWN WITH BRIAN LAMBTON, CORIN’S GLOBAL PROFESSIONAL EDUCATION MANAGER, TO DISCUSS HOW MATERIAL CHOICE IS KEY TO ROBOTIC JOINT SURGERY.
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orin, a UK-based company that according to Lambton, has seen significant growth over the last four or five years, has recently begun working with global investment firm, Permira.
Henry Minello, principal in the healthcare team of Permira said, “the US market for robotics in orthopedics is growing at a very rapid pace. We expect Corin to remain at the forefront of development in robotics and computer-assisted surgery.” Lambton stated that, “in November last year, we bought an Australian company called Global Orthopedic Technologies (GOT). This is how we began our relationship with OMNI Orthopedics.” OMNI’s proprietary robotic platform, OMNIBotics, allows surgeons to conduct patient-specific total knee surgery, and designs, engineers, manufactures and distributes a wide range of proprietary hip and knee implants. Stefano Alonsi, Corin’s CEO explained that the combination of OMNIBotics for the knee and Corin’s optimized positioning system (OPS) for the hip, and said how he thought, “Corin is now uniquely positioned to address functional patient-specific joint replacement.” “It is the perfect time to be part of a larger organization that shares our dedication to improving the lives of individual patients through technological innovation,” Rick Epstein, OMNI’s CEO said. “We are thrilled to be joining Corin to maximize the potential of our robotic solutions.”
is now expected to be much longer,” said Lambton, before raising the issue that, we are operating on some of these people in their forties and fifties, and therefore what is the expected life expectancy for these people? Addressing the above concern, Lambton mentioned that some incredible work has been conducted by scientists at Massachusetts General Hospital, with regards to developing polyethylenes that include vitamin E as an antioxidant. The antioxidant when included in the polyethylene is able to provide oxidative stability in vivo, and therefore the life span of that polyethylene material will be extended even further. Lambton mentioned how their vitamin E-enriched polyethylene was named ECiMa and he stated, “We hope this is the Holy grail of polyethylene.”
According to Lambton, “everybody is very different and therefore the implant needs to be positioned not just with precision but also with accuracy for that individual patient.” Describing the technology Lambton claimed, “OMNI has this incredible technology which enables you to do part of the operation initially, and then during the operation, without any prior scan, you are able to use a computer and robotic solution to use live data to analyse that individual patient’s needs. You can then make all of the cuts that you require via robot technology.” This means there is less pain for the patient and faster rehabilitation due to the unique implant positioning for each individual patient. Lambton explained that there is no doubt that materials play an enormous role in orthopedics, “over the years we have discovered a lot more about the designs of the implants and also the material itself.” Originally polyethylene was manufactured and stored in oxygen which was very bad for polyethylene. Now however, the way in which we eliminate the free radicals that are left behind has changed. “If we can control the cross linking process, we can reduce the wear of polyethylene significantly. Following this revelation, joint replacement length WWW.MEDICALPLASTICSNEWS.COM
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AARON JOHNSON, VICE PRESIDENT OF MARKETING AND CUSTOMER STRATEGY, ACCUMOLD DISCUSSES TRENDS TOWARDS ULTRA-THIN WALLED MICRO MOLDING, AS WELL AS ELECTRONICS AND THEIR ROLES WITHIN MEDICAL DEVICES.
COVER STORY
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n the run up to MD&M West 2019 in Anaheim, California, it was announced that a key topic of interest would be trends within electronics, with a particular focus on the miniaturization of devices that customers have now come to expect as the norm. Accumold found itself talking ultra-thin walled micro molding, as well as electronics in medical devices during MD&M West. Ultra-thin walled micro molding is becoming increasingly challenging as a result of trends within electronics such as wearables, and due to the pressing demand to improve patient care. Johnson provides a unique insight as to how this affects the manufacturers of small and micro injection molded components. WHAT ARE THE CHALLENGES ASSOCIATED WITH ULTRA-THIN WALLED MICRO MOLDING? There are many challenges associated with ultra-thin walled micro-molding. The strong drive to reduce form factors means that design engineers are often looking towards wall thickness as an opportunity to gain space. As a result, this is putting a lot of pressure on component manufacturers and is pushing ultra-thin walled micro molding to the extreme. One of the main challenges is the profound relationship between the geometry and the material selection, particularly with high aspect ratio wall sections. In these circumstances it can be hard to follow specific guidelines. An ultra-thin wall section e.g. about 75 microns thick over a high aspect ratio of more than 25:1, is achievable but is very material dependent. When you’re looking for material properties to match the geometry you’re after it can be very challenging. For example, polyetheretherketone is a commonly desired biocompatible resin but is not friendly to high aspect ratio ultra-thin molding. Liquid crystal polymers (LCPs) on the other hand can perform very high aspect ratios but may not have the physical characteristics you’re after. It becomes more than just a simple guideline for aspect ratio and usually comes down to the experience of the micro molder. WHAT ARE SOME ESSENTIAL APPLICATIONS OF ULTRA-THIN WALLED MICRO MOLDING? Wearable devices, micro surgical tools, diagnostics, transcatheter or endoscopic components are a few of the common medical devices looking to push the limits when it comes to ultra-thin walled micro molding. Applications that are looking to do more in the same space, or more in less, are commonly looking to push the limits with their form factors. The more they can reduce the form the more space they can have for other components, or the more they can reduce the overall footprint. WHAT IS THE BEST MATERIAL CHOICE FOR ULTRA-THIN WALLED MICRO MOLDING? LCP is probably one of the best performing materials when it comes to high aspect ratio ultra-thin walled micro molding. Other materials including polyethylene, polypropylene, or polyoxymethylene are also very capable with these dimensions as well. In some situations, polymethyl methacrylate, polybutylene terephthalate or nylon could also be good choices. Each of these materials present their own advantages and limitations. The design plays a key factor in the success of a material for this purpose. WHICH ELEMENTS SHOULD MANUFACTURERS TEST WHEN USING ULTRA-THIN WALLED MICRO MOLDING? The structural and mechanical properties will need to be tested if they are important for the functionality of the part. Environmental testing is also very common, especially in high heat applications where material stability is important. Plastic parts that don’t have a lot of mass can sometimes behave unexpectedly, therefore a test is always recommended. WHAT ARE THE LATEST TRENDS FOR MEDICAL DEVICES? It is thought that medical devices will never stop looking to reduce their size. There is a high demand to produce more minimally invasive devices, and to find newer opportunities within patient care that can reach further into the
body with less effort. The medical device market continues to push the limits of mechanical design with the hope of improving patient care. WHAT ARE WE SEEING IN NEW APPLICATIONS? Wearable applications are the latest trend within medical devices. It is thought that putting more care in to the hands of the patients often provides better data and more immediate feedback resulting in better care. Advancements in electronics, drug delivery, diagnostics, etc., have all brought innovative products to market. Manufacturing processes like micro molding have helped enable these technologies to provide the most value to the patients with the least amount of impact possible. WHAT IS IMPORTANT TO CONSIDER WHEN CHOOSING A MANUFACTURING PARTNER LIKE ACCUMOLD? Experience is the number one factor when choosing a manufacturing partner for micro molding. Partners are required to build the tools, process the materials and produce high quality output, and this can be daunting. Secondarily, whenever interviewing a new potential partner their capability is not the only important factor. It is also very important to make sure that they are able to sustainably meet the scalability required, as a disruption in the supply chain can be extremely frustrating. It is very important to ensure your new partner is well equipped beyond the prototyping phase. WHY IS IT IMPORTANT TO CHOOSE A MANUFACTURING PARTNER THAT UNDERSTANDS TRENDS IN ELECTRONICS? As with any product or service keeping up with the needs of the customers is non-negotiable. It is important to understand that form factor reduction and pushing the limits with micro injection molding could be key future solutions. Having a manufacturing partner that understands the trends in electronics enables the organization to focus on the mechanical trends and the material science driving tomorrow’s products.
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RAPID PROTOTYPING & 3D PRINTING
ANGELO GENTILE, SENIOR CONTENT WRITER, PROTOLABS DESCRIBES HOW COMPANY LEADERS HOPE TO LAUNCH THE QUANTRA SYSTEM IN THE US FOLLOWING ITS INTRODUCTION IN EUROPE LAST YEAR.
time for take off
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s often happens in the medical industry, innovative ideas hatched in university research settings, generate innovative companies, which create innovative products. HemoSonics was found in this way.
PROTOLABS PRODUCED THE CASING OR SHELL FOR HEMOSONICS’ QUANTRA SYSTEM BLOOD-CLOT ANALYSIS MACHINE
The Charlottesville, Virginia-based medical device company was started in 2005 by two professors and a post-doctoral research student at the University of Virginia School of Medicine’s biomedical engineering program; Bill Walker, Mike Lawrence, and Francesco Viola respectively. The trio identified a method for measuring the stiffness of blood clots by using ultrasound imaging technology, and created a system built around that technology aimed to improve patient outcomes and reduce costs. A number of years followed of extensive research and development, which included securing key patents, conducting numerous hospital studies, and consulting with physicians and other clinicians. More recently, HemoSonics has been prepping to bring its Quantra System diagnostic products to market, with prototyping and end-use manufacturing help from Protolabs. In fact, HemoSonics has worked with Protolabs since 2011, from those early research and development days to more recent, enduse production work on the Quantra System. HemoSonics successfully launched its products commercially last year in Europe and hopes to enter the US market soon. HemoSonics now has more than 50 employees and has expanded its offices into Durham and North Carolina.
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RAPID PROTOTYPING & 3D PRINTING
A NEED FOR SPEED AND FLEXIBILITY, SOLVED BY AN AGILE SUPPLIER In HemoSonics’ early research and development days, engineers were “iterating through multiple designs under tight deadlines,” said Andy Homyk, senior engineer, who joined the company more than six years ago when it had just five employees. “We were on a tight timeline so we needed a supplier who could machine parts for us quickly, within a couple of days.” A number of suppliers contacted could not meet those challenging deadlines but Protolabs could, Homyk remembered. “The difference in lead times was dramatic.” That was in 2012. Since that time, Protolabs has produced hundreds of prototypes and thousands of components for HemoSonics, using 3D printing, computer numerical control machining, and injection molding for a variety of projects and parts such as robotic fixturing, thermal control units, pneumatic manifolds etc. “Speed and flexibility, being able to deploy different manufacturing options, and a commitment to customer service, are the main reasons we use Protolabs,” Homyk said. More recently, HemoSonics looked to Protolabs for help with the skins or casings that fit around the Quantra System, Homyk explained. HemoSonics engineers needed design prototypes about the size of a computer monitor, first using 3D printing and then injection molding, to demonstrate form, fit, and function of the Quantra System to physicians at various hospitals. The Quantra System is designed as a rapid, easy-to-use diagnostic platform that uses disposable cartridges to conduct a panel of tests. The Quantra Hemostasis Analyzer is designed for use in critical care settings that require results to be generated quickly from an instrument that is easy to operate at the point of care. A challenge emerged when the project switched from additive manufacturing to injection molding. “These are pretty big parts, so one of the molding challenges, in prototyping, was color matching,” Homyk said. MOLDING MATERIALS AND FINISHING TOUCHES HemoSonics wanted these casings Pantone color-matched to its marketing department’s specifications. One of the ways Protolabs normally does that in the injection molding process, is to take the plastic resin in the natural color of the specific material chosen, and apply around a three percent salt and pepper mix of colored resins. Final parts are typically very close to the preferred color, but because of the nature of HemoSonics parts, some swirling and flow marks were showing up on them. The first batch of parts did not look good cosmetically,” Homyk said.
molded parts, such as heat staking and pad printing. Heat staking is a process that uses a heated stake to melt metal threaded inserts into plastic parts. This makes it so that screws can be used to attach the Quantra System casing parts to a frame, for example. Pad printing is a process that uses a stamp called a cliché to apply colored logos or decals to parts. HemoSonics used pad printing to put company logos on the Quantra System case parts. Protolabs plans to make these and other finishing options such as mold texturing and part assembly more widely available in the future. THE OUTCOME Homyk believes those long years of research and development, multiple design iterations and prototypes, numerous hospital studies, scores of visits to physicians and other clinicians, the securing of key patents, and the landing of important certifications in Europe including the CE Mark, is finally paying off. Last year, the Quantra System launched in Europe, and company leaders hope to launch the Quantra System in the US. Going forward, Homyk expects Protolabs to continue to play a key supplier role to support the company’s work. THE QUANTRA SYSTEM BLOODCLOT ANALYSIS MACHINE MEASURES THE STIFFNESS OF BLOOD CLOTS BY USING ULTRASOUND IMAGING TECHNOLOGY
Undaunted, Protolabs went to one of its plastic resin suppliers and the supplier collaborated with Protolabs and HemoSonics to pre-compound the colors. “They mixed the plastic with the dye before molding to get pellets with a nice uniform color,” Homyk said. This custom, pre-colored resin produced flawless parts. “This again speaks to Protolabs’ customer service going the extra mile, and to how agile the company can be.” Material selection was also carefully considered, Homyk stated, given that a requirement of almost any kind of medical device is that it needs to meet certain flammability standards. For the casings, HemoSonics opted for an acrylonitrile butadiene styrene plastic that met those standards and also offered durability. Beyond machining, 3D printing, and injection molding, HemoSonics engineers also used some additional finishing options on the injectionWWW.MEDICALPLASTICSNEWS.COM
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TRACK: Smart manufacturing & 3D printing hub TITLE: How augmented reality will change manufacturing TOPIC: The session hopes to explore how augmented reality could improve productivity, efficiency and safety within manufacturing. SPEAKER(S): To be confirmed DATE: Tuesday June 11th TIME: 10:30-11:00 BOOTH NUMBER: #102
TRACK: Medtech hub TITLE: Choosing the right plastic for your medical device TOPIC: Plastic plays a key role in medical devices, and therefore choosing the right material is important. This session aims to discuss factors to consider when selecting material for a medical device. SPEAKER(S): Michael Paloian (president, Integrated Design Systems), Lauren BoBrek (business development leader, Sabic), Ed Flaherty (application development engineer, Nexeo Plastics), Ken Breeding (new business development associate, Eastman Chemical Company) and Larry Acquarulo (CEO, Foster Corporation) DATE: Tuesday June 11th TIME: 12:00-12:45 BOOTH NUMBER: Medtech hub, #1669
TRACK: Medtech hub TITLE: What medtech companies can learn from DIY medical devices TOPIC: In this session MakerHealth will discuss examples of DIY medical devices. SPEAKER(S): Nik Albarran (principal engineer, MakerHealth) DATE: Wednesday June 12th TIME: 10:30-11:00 BOOTH NUMBER: Medtech hub, #1669
TRACK: Smart manufacturing & 3D printing hub TITLE: 3D printing success stories TOPIC: This session will discuss examples aiming to change the manufacturing world. SPEAKER(S): To be confirmed DATE: Wednesday June 12th TIME: 12:00-12:45 BOOTH NUMBER: #102
TRACK: Packaging hub TITLE: Why bulk could be the wave of the future in high-pressure processing TOPIC: This session discusses bulk processing, and its first implementation. SPEAKER(S): Viniccio Serment - Moreno (USA applications manager, Hiperbaric) DATE: Thursday 13th June TIME: 14:00 - 14:45 BOOTH NUMBER: #2370
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What's on at
MD&M East? IF YOU HAVE BEEN CONSIDERING ATTENDING THE MEDICAL DESIGN & MANUFACTURING (MD&M) EAST EVENT ALONGSIDE 8000 ADVANCED MANUFACTURING PROFESSIONALS THIS SUMMER, THEN DISCOVER MORE ABOUT THE EVENT BELOW. IT IS NOT TOO LATE TO REGISTER FOR WHAT IS SURE TO BE AN INTERESTING EVENT. WWW.MEDICALPLASTICSNEWS.COM
MD&M EAST
WHAT IS MD&M EAST? MD&M East is the East coast’s largest medtech event. It offers professionals the chance to see the latest technologies and solutions within areas such as biocompatible materials, components, assembly, and contract manufacturing. WHEN IS THE EVENT? MD&M East is taking place in the Jacob K. Javits Convention Center, New York, New York between June 11th and June 13th, 2019. WHY SHOULD I ATTEND? Many of the major companies involved in medtech will be exhibiting at the event. Some of the exhibitors that will be there include: • 3M Medical Materials & Technologies • Accumold • B. Braun OEM Division • Branson Ultrasonics • Keyence Corporation of America • MW Medical Solutions, Phillips-Medisize • Qosina • Teleflex Medical OEM • Zeus The event is also held alongside five other shows; East Pack, Atlantic Design and Manufacturing, Automation Technology Expo (ATX) East, PLASTEC East and Quality Expo. One expo pass will provide you access to all six of these trade shows. Additionally, the event will host the prestigious Medical Design and Excellence Awards (MDEAs) again this year. These awards will be presented to innovative companies within the medtech industry. The finalists will be announced in May, and the awards ceremony will take place on June 11th 2019 in the Jacob K. Javits Convention Center, where the main event is taking place. Previous winners of these awards within different categories in the last year include, the ‘Equashield Pro Pharmacy Robot’ by Equashield. This robot enables intravenous drug preparation which is normally conducted by humans in a hospital pharmacy to be conducted by a robot. This automated system will remove the human error element that currently exists within this practice.
confirming proper sterilization of the reprocessed surgical instruments within 30 minutes. This is much faster than some other systems which can take up to 24 hours. The system provides automated record keeping, compliance checks, and on-screen instructions. There will also be a medtech showcase taking place that will cover a wide range of topics including: • 3D printing and additive manufacturing • Adhesives • Automation • Injection molding • Manufacturing equipment • Medical device components • Medical packaging • Medical plastics WHO IS SPEAKING AT THE EVENT? There will be three hubs on the expo floor consisting of: • The medtech hub • Smart manufacturing and 3DP hub • The packaging hub Within each hub there will be sessions throughout the event on its respective topic. Some sessions of interest are highlighted on page 18.
Gold prize was also awarded to Willow, in collaboration with IDEO for the ‘Willow Breast Pump’. This is the first all-in-one breast pump that is able to fit inside a bra. It is hands free and therefore aims to reduce the impact breast feeding can have on a woman’s everyday life.
SOCIAL MEDIA There will be an app launched closer to the event which will be available on the Apple and Android app store. For now though you can also stay up to date with the event on social media, by following the hashtag #AdvMfgExpo.
‘STERRAD VELOCITY Biological Indicator (BI) System’, is an Advanced Sterilization Product (ASP) by Johnson & Johnson which was also a winner at the 2018 awards ceremony. The system works by a hydrogen peroxide BI
For more information on this event, please take a look at the event website.
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COMPONENTS & ASSEMBLY
ASHLEY PHILIPP, MARKETING COORDINATOR, INJECTECH HIGHLIGHTS THE NEW INTERNATIONAL ORGANIZATION FOR STANDARDIZATION (ISO) 80369 STANDARDS AND ITS IMPORTANCE FOR ENSURING PATIENT SAFETY.
Setting the standard
B
y complying with the new ISO 80369 standards, a component supplier can help ensure that when an individual enters a hospital or emergency room they will be provided with the correct fluids and/or gases to keep them alive. The recent publication of the ISO 80369-7 standard will force companies to consider component design changes within the medical industry. This standard focuses on patient safety, putting manufacturers mindset on new quality connections, along with other standards within ISO 80369. The ISO 80369 series of standards aims to minimize misconnections between small-bore connectors of different functional categories. ISO 80369 part 1 lays out the general requirements for small bore connectors and defines the protocol by which new small-bore connector categories can be added to the 80369 series. Part 20 describes functional test methods for small-bore connectors such as tests for leakage, disengagement by axial load, and resistance to overriding. Parts 2 through to 19 were intentionally left open by the standard’s developers so that new categories of smallbore connectors can be added to the series as new medical methods and applications arise. These small-bore connectors are used in respiratory, enteral, urinary, blood pressure, neuraxial and intravenous systems and historically used an identical luer design. The use of luers across medical devices increased the likelihood of a misconnection between the delivery systems used on a patient. Misconnections can cause leaks which lead to an improper dosage of medication or delivery of an incorrect fluid or gas which can cause complications or even death. The publication of the 80369-7 standard for intravascular and hypodermic applications has tightened dimensions and functional testing for luer connectors. A clinical lead EMT in Fort Collins, Colorado, shared his perspective on why fittings and strong connections are important to the health of individuals he comes in contact with on the job. He explained that he uses a multitude of
ISO
80369
components on tube sets including luers which are used in patient monitoring. These fittings help deliver fluids and medications into patients. He stated that, “if these fittings don’t successfully connect to the tubing or the IV bag, you can have a leak in your line or tubing, which could lead to mis-dosage of medication to the patient.” In high stress situations, we need to rely on plastic fittings to do their job. With established standards, like ISO 80369-7, there is greater assurance that the connection will be correct and functional for the patient. The publication of the ISO 803697 standard has already begun to cause a large stir in the medical device industry and will require increased recognition from any companies or individuals looking to introduce a new device design in 2020. According to the FDA website, as of 31st December 2019, the agency will no longer accept new device designs for intravascular or hypodermic applications that incorporate luer connectors using the ISO 594 standard. It is important to note however, that even with the introduction of the new standard the dimensions and tolerances given in ISO 80369-7 are similar enough to those given in the previous standard for luer connectors (ISO 594) that most 80369-7 connectors will be backwards compatible with legacy connectors. Current medical devices will still be able to use both ISO 594-1, 594-2 and ISO 80369-7 connectors. With an understanding of how important these new fittings will be in providing quality patient care, why would manufacturers hesitate to incorporate this new standard?
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INNOVATION IN IMPLANTS
MADE TO ORDER THE RECENT INNOVATION OF CUSTOM MADE IMPLANTS HAS THE POTENTIAL TO IMPROVE SURGICAL PROCEDURES. THE USE OF POLYETHER ETHER KETONE (PEEK) IN THESE IMPLANTS CAN PLAY A KEY ROLE IN PREVENTING POST-SURGICAL INFECTION. 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.”
Discussing a case where Granta successfully treated a patient with a custom implant, Martin Carcaño, head of biomedical design, Granta mentioned how the implant a surgeon had originally put in to the patient had become infected just two days later. “They had to remove the implant again”, stated Carcaño. Commenting on the manufacture of the implant, Monroy explained, “it’s the easiest to design, probably most difficult to fabricate because it’s a very organic and complex shape.” Monroy went on to talk through the process of creating a custom implant: “We receive the CT scan from the patient. From there we propose a design that may help to fix the problem, and then we 3D print a model of the skull and the implant that we are proposing.” The next step according to Monroy is to then discuss with the doctor at this stage if this is the best option for this patient. “We manufacture it in a five-axis Computed Numerical Control (CNC) machine. We manufacture the final implant in the biocompatible material, that then is shipped to the hospital to be sterilized”, Monroy explained. “We use material that is completely biocompatible, that is called PEEK, and it’s a material that has many properties.” PEEK is advantageous as the body will not attack this material, and therefore its use will not result in an infection. Looking back on the procedure, Monroy said, “when they took out the implant from the sterilized bag and they put it on the skull, we all saw that it fit perfectly.” Carcaño concluded, “when you start to design something that is so critical for a human being, I mean a part that he or she relies on to live, it is a completely different level. I was so excited to be a part of that.”
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JOIN THE EAST COAST’S
LEADING MEDTECH EVENT
Medical Design & Manufacturing (MD&M) East is the largest and longestrunning medtech event on the East Coast. At MD&M East, you’ll source from the region’s largest collection of cutting-edge suppliers, deepen your expertise with free, conference-level education, and network with thousands of professionals who can help you advance your projects.
JUN 11-13, 2019 // NEW YORK, NY JACOB K. JAVITS CONVENTION CENTER
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INJECTION MOLDING
Location, location, location MEDICAL PLASTICS NEWS GROUP EDITOR DAVE GRAY RECENTLY SPOKE TO MICHAEL FAULKNER, PRESIDENT OF BMP MEDICAL TO DISCUSS THE NEW PLASTICS MANUFACTURING FACILITY.
E
arlier this year, BMP Medical announced the opening of its new medical plastics manufacturing facility. Michael Faulkner, president of BMP medical stated that the new location Sterling, Massachusetts was chosen for several reasons, including its close proximity to the previous location in Gardner, Massachusetts. In Faulkner’s words this makes the new location, “optimal for our long-tenured and experienced workforce.” The plastic contract manufacturing facility will aim to serve as a hub for making BMP Medical’s full range of manufacturing services available to the growing medical device and diagnostic manufacturing Original Equipment Manufacturers (OEMs) marketplace. “Our founder first established several businesses in Leominster, Massachusetts which is also known as the Pioneer Plastics City”, Faulkner highlighted. “The 80,000 square foot building also had pre-existing injection molding infrastructure and was an ideal setup for our manufacturing equipment.” The new facility will accommodate, “plastic medical device injection molding contract manufacturing services to leading OEMs for Class 1 medical devices, exclusively serving the medical device industry.
over their supply chains” and this can be challenging. “Our commitment to MedAccred, a robust program managed by the MedTech industry, provides supply chain oversight via standardized audit criteria and is helping to address OEMs concerns. “Some of the leading OEMs have participated in helping to develop this specific criterion. BMP Medical is the first injection molding company to achieve accreditation from MedAccred.” Faulkner concluded with, “BMP Medical’s robust quality systems reduce overall risk for OEMs through an entire product life cycle.”
“Our capabilities include class 8 clean room injection molding, injection blow molding, 2-shot molding, insert molding, finish goods assembly & packaging.” Faulkner mentioned how the site would be opened for tours for potential medical and diagnostic OEM manufacturing partners throughout 2019. Prior to the move, investments were made which Faulkner stated included a, “new glycol based chiller system, an upgraded material handling system, a new heating, ventilation and air conditioning system, upgraded electric panels and wiring, 3 new all electric presses and additional robotics.” With regards to new future expansions, Faulkner said, “this new facility allows for our forecasted business growth. We will be able to allocate more assembly, packaging, and cleanroom space for further product life-cycle support. Designs are in place for increasing manufacturing capacity which will accommodate an additional 14 -16 machines.” Faulkner mentioned how, “OEMs require greater quality control
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INJECTION MOLDING
Holding it together MARTIN MANKA, ARBURG SENIOR SALES MANAGER, MEDICAL DESCRIBES HOW A TWO-COMPONENT WET-IN-WET MOLDING PROCESS PREVENTS FREEZE-CRACKING OF BLOOD-SAMPLE TUBES AND HOW ARBURG PLAYS A KEY ROLE WITHIN THIS PROCESS.
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he French Blood Donor Centre, and other institutions within Europe, the United States and Australia come to Jako Meditec, Szekszárd, Hungary, for tubes, closures and racks used to store blood samples.
Their requirements are quite specific stating that each tube and the blood sample inside it must be uniquely identifiable, and the tubes must also withstand storage at -35⁰C for three years. To meet those demands, Jako worked with ARBURG and a German mold maker to develop a unique twocomponent molding process they refer to as wet-in-wet molding. The process yields transparent tubes made from polypropylene (PP) with a black PP base that can be laser marked with a unique data matrix (DM) code that meets the traceability requirement. However, Jako found they couldn’t use a rotary or sliding split mold which is the conventional approach to two component injection molding, because injecting the two materials sequentially created a weld line that was prone to cracking during the thawing of the blood samples. This problem led to the development of the wet-in-wet process. Instead of injecting sequentially, explains Stephan Hauri, Jako project manager for plastic injection molding, “both components are injected almost simultaneously into the mold. Here, they flow towards each other and fuse together when they meet.” This sophisticated innovation was jointly implemented with ARBURG Hungary and the German mold manufacturer POLAR-FORM,” says Joachim Koch, who, along with his brother, Andreas Koch, founded Jako Group 20 years ago and formed Jako Meditec in 2015. The two share the title of managing director. Their father, senior partner Adam Koch came up with the IN THE CLEAN ROOM, SOME OF THE PRODUCTS ARE SUBJECTED TO AN OPTICAL FOLLOW-UP INSPECTION
idea for the wet-in-wet process and Jako also had the support of the ARBURG application technology group during the development and implementation stages of the project. Joachim Koch states that the ARBURG control system “operates with a precision down to a hundredth of a second during injection.” Such precision is necessary because the amount of clear and black material needs to be consistent so that the black section which gets the DM marking is the right size. The first 8-cavity mold performed well, producing in excess of two million shots. Today, a molding cell docked to a class 8 clean room is used to produce the tubes. The centerpiece of the cell is a 2,200-kN (245-ton) hydraulic ALLROUNDER 570 S, which is fitted with two size-170 (3.7-oz) injection units and a 32-cavity mold. In the clean room, the tubes are stored temporarily until they are labelled, assembled, and inspected according to customer specifications. “For this purpose, we work with island solutions,” explains Hauri. In total, Jako operates five ALLROUNDERs and around 20 molds with between one and 32 cavities are in operation to produce the appropriate screw caps, thermoplastic rubber or elastomer (TPE) plugs and seven different rack types. Joachim Koch says Jako expects “to produce around 1.5 million tubes per month.” Andreas Koch concludes by saying, “The ARBURG machines have been in continuous operation very reliably since the start of production and have proven extremely well suited to their task.”
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DIGITAL HEALTH MAKING WEARABLES
LACEY HARBOUR, REGULATORY AND VALIDATION SPECIALIST FOR KEN BLOCK CONSULTING EVALUATES THE EXPLAINABILITY FOR ARTIFICIAL INTELLIGENCE (AI) WEARABLES AND HEALTHCARE DEVICES IN THE UNITED STATES (US).
ROBUST ROBOTS?
I
walk into Andersen Bakery within Ueno Station in Tokyo, select a few pieces of bread, and hand the delectable treats to the young lady behind the check-out station. Each piece of bread’s outline is highlighted and labeled on the screen so that I, the end user, can confirm that the system is correct. Upon very quick confirmation, I use the automatic payment system to pay out. The whole process took less than 3 minutes from bread selection to leaving the very busy bakery and with this naturally explainable AI, I felt confident that I paid the correct amount for my purchase. With AI being integrated into medical devices, industry 4.0, and quality management systems, developers need to understand how much and what kind of explanation is necessary for a system’s intended use, as well as the associated risk involved. To explore this, let’s look at some recent devices that have received Food and Drug Administration (FDA) marketing authorization.
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Within the US, the diabetic retinopathy detection system, IDx-DR, was granted a de novo decision under the product code PIB on April 11th, 2018 (DEN180001). Upon this decision date, the IDxDr became the US’ first legally marketed, fully autonomous, deep learning medical device that provides screening decisions without a clinician. This device was deemed to be reliable due to its explainability, or explicability as the British Standards Institution (BSI) / Association for the Advancement
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DIGITAL HEALTH MAKING WEARABLES
of Medical Instrumentation (AAMI) standard development group calls it. Like the Andersen Bakery system, this system utilizes images to observe markers (or biomarkers). However, it does not directly report the observed biomarkers to the end users, only the screening decision. This system’s explainability was considered enough for FDA to grant the de novo. On March 8th 2018, Medtronic’s Guardian Connect Continuous Glucose Monitoring (CGM) System (approval letter: P160007) was approved with the indication of continuously monitoring glucose levels within interstitial fluid for patients with diabetes mellitus. Glucose concentration data that was detected by the wearable sensor is tracked in real-time through the Guardian Connect app. Using the accumulated data, the system is designed to alert the user of potential glucose excursions up to an hour in advance of the predicated event. A second app called Sugar.IQ (using IBM Watson) can be used to provide personalized recommendations about diet and exercise based on sensor and other collected data. The Guardian system was only approved to be a predictive indicator and event alert for when end users must test their glucose levels with a cleared blood glucose monitor. Explainability of the AI used in both the Guardian and IDX-DR systems was demonstrated through traditional clinical evaluations. As end users, we expect the burden of explainability to be addressed by regulatory agencies like the FDA. Recently AlivCor, the maker of the Kardia Band System ECG (K171816) gained clearance for the KardiaAI system on March 11th, 2019 (K181823). Though the AlivCor website had no information on the new product at the time of my search, the product was cleared with product codes DQK (programmable diagnostic computer) and DPS (electrocardiogram) with the primary classification under ‘Computer, Diagnostic, Programmable’. Product code DQK has been used for products like Abbott’s EnSite Velocity Cardiac Mapping System (K182644 in 2018) that uses intelligent automation based on live 3D images collected during electrophysiology studies. DQK has also been used for products like the VivoMetrics LifeShirt Real-Time (K043604 in 2005) which has the intended use of recording physiological data for later analysis by a physician. As there is no specific product code that identifies the system as using predictive algorithms, are these existing product codes enough to describe what is really going on with the device? In addition, if one were to trace predicate ‘K numbers’ for most devices that have several iterations, one would reasonably find simpler indications as the predicates lead back in time. For example, legacy Abbott EnSite system with K071818 in 2007 had the indication to create color-coded isopotential maps for the physician’s use and, the even older EnSite 3000 system, K983456 in 1999, has an indication for storage and display of intracardiac electrograms only. Is it appropriate to group AI or continuous learning algorithms with those product codes that do not have the history to support AI safety and efficacy claims? Do FDA reviewers across the board have the training to recognize AI devices, understand the limits of explainability, and determine the appropriateness of the explainability for the intended use? The Defense Advanced Research Projects Agency (DARPA) states that explainable AI will be essential if users are to understand, appropriately trust, and effectively manage this incoming generation of artificially
intelligent partners. This statement is equally true for intelligent or augmented algorithms used in devices. However, is the current method of device evaluation providing enough confidence? Maybe. For example, the IDx-DR had been validated against the Fundus Photography Reading Center (FPRC) reference standard with a sensitivity of 87% and specificity of 91% for the locked algorithm. Therefore, despite biomarkers not being fully explained to the end user, that end user nurse in the doctor’s office would not require or desire that level of explanation. As the device is indicated for use only with patients already diagnosed with diabetes, the patient risk for the explainability of this device could be considered mild. The Guardian Connect CGM has a similar situation in that the device is not for making therapy adjustments but alerts the user to check their blood glucose levels; therefore, the level of required explainability would be lower even through the risk is still high enough to merit the premarket approval pathway. To address this non-linear relationship between risk and the need for explainability, the BSI/AAMI AI standard development working group will undergo an exercise to address risk management strategies for AI Software as a Medical Device (SaMD) and mapping of essential principles for safety and performance. Other working groups, like Xavier AI Summit are exploring what explainability is and how explainability is related to confidence and adoptability. Finally, stakeholders are watching to see if the FDA’s pre-cert program will help improve explainability and confidence for AI in devices.
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TUBING, CATHETERS & STENTS
JOE ROWAN, PRESIDENT AND CEO OF USA AND EUROPE FOR JUNKOSHA DISCUSSES HOW INNOVATIONS SUCH AS PEELABLE HEAT SHRINK TUBING (PHST) ARE NECESSARY TO TACKLE FUTURE CHALLENGES WITHIN THE MEDICAL TUBING SUPPLY CHAIN.
THE MISSING LINK T
he future of the medical tubing sector is highly dynamic, not least because there are a variety of pressures on organizations within this space to provide solutions that are not only of the highest quality but also deliver cost savings throughout the product lifecycle. Take the catheter market as a prime example of these challenges. In the world of neurovascular and other complicated techniques, catheter manufacturers are being pushed for solutions that not only deliver complex procedures more efficiently but also provide cost savings at every turn. In what is a highly cost-conscious marketplace, peelable heat shrink tubing products that enable catheter manufacturers to advance efficiencies through streamlining their workflows is going from a ‘nice to have’ to becoming a critical requirement. PHST CONTINUES TO SAVE VITAL TIME AND MONEY The PHST market is an exciting area to be in. Not only does it aim to address healthcare customers’ unmet needs, solutions including ultra-small PHST also pave the way for progressively smaller catheter-based procedures – a continual requirement for medical device manufacturers. The reasons, aside from their desire to meet the healthcare sector’s needs, are because PHST ultimately reduces Total Cost of Ownership (TCO) for the catheter manufacturer. Since companies no longer have to use the process of skiving the heat shrink material from the catheter, PHST can help them produce the final product more rapidly with improved yields and lower inspection levels while being more ergonomically safe. In addition, as the healthcare sector continues to push for cost savings to be made all the while delivering excellent patient care, solutions such as Junkosha’s 2.5:1 PHST are a viable option. Providing the ability to rationalise processes in the manipulation of a catheter’s baseline materials by reflowing these quickly and efficiently, this solution can potentially act as a catalyst to provide cost savings for catheter manufacturers.
WHAT NEXT FOR THIS BURGEONING MARKET? Into the future, numerous challenges face the medical tubing supply chain in the US and European markets including; Stringent regulation, the need to make procedures less invasive and the enablement of a wider variety of operations across harder to reach parts of the body, increasing healthcare costs and the need to streamline workflows and processes - especially for catheter manufacturers. Although these various challenges differ around the world, they all require one thing - innovations that improve outcomes for patients and provide clinicians and other endusers with technologies that make their lives easier, reduce costs, and save time. For this reason, continuous innovation must be at the heart of the healthcare sector’s requirements. Without this, the unmet needs will continue to be just that: unmet.
APPLICATIONS According to Robert LaDuca, CEO of medical device tubing and catheter components manufacturer Duke Empirical, there are a number of applications where this new high ratio PHST technology will enable better processes and cost savings. These include tapered cardiovascular devices such as multi-lumen braid reinforced Peripherally Inserted Central Catheters (PICC), alongside a wide variety of next generation catheter designs that have varying diameters such as cardiac implant delivery systems where the implant is located in a distal segment of the catheter that is usually larger than the proximal portion of the shaft. In addition to enabling new processes for manufacturers in their development of innovative products, and the faster and more forceful recovery of the 2.5:1 PHST products can help reduce or eliminate air entrapment which can be an unwanted cause of bubbles and associated product defects such as fish eyes, voids, and insufficient strength of bonded layers.
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COMPOUNDING SOLUTIONS, A SPECIALIST IN MEDICAL EXTRUSIONS, HIGHLIGHTS TECHNOLOGIES SUCH AS REZILOK WHICH AIM TO SUPPORT THE CURRENT DEMANDS IN THE MEDTECH SECTOR.
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n the medical device industry, the trend towards minimally invasive surgical techniques is the driving force for smaller, more innovative medical devices.
In catheter design, the designer must not only consider the functional requirements of the application, but also the key performance requirements of the medical tubing properties. The ability to hold tight tolerances is critical when selecting the ideal design for a particular medical application. Generally, a single polymer material will not meet all of the performance requirements adequately. As a result, designs have become very complex, with different materials required in different areas of the catheter. An example is a typical balloon catheter, where the inner diameter of the catheter needs to be very smooth and lubricious to slide with minimal effort over a guidewire along the tortuous bath of the anatomy to the treatment site. Typical materials used are fluorinated ethylene propylene (FEP), polytetrafluoroethylene (PTFE) and high-density polyethylene (HDPE). Fluoropolymers provide the best lubricity, however, they present bonding and processing challenges. An example is HDPE loaded with Compounding Solutions’ Mobilize technology, a lubricious additive that can be incorporated with the inner layer material to reduce the coefficient of friction. If a HDPE is used on the inner layer and a nylon or poly-ether block amide (PEBA) on the outer layer, then a bonding or tie layer must be employed to bond these dissimilar materials during the extrusion process. ReZilok Rx 101, is a new linear low-density polyethylene with grafted maleic anhydride
tie layer resin developed by Compounding Solutions. ReZilok meets the requirements of the medical device industry, complies with ISO 10993-5 cytotoxicity, whilst claiming to offer superior bondability. In order for the medical practitioner to detect the distal end of the device when it is deep within the anatomy, metal marker bands of the platinum iridium type are often used. These marker bands show up much brighter than other parts of the device under fluoroscope, ensuring the balloon is correctly located before inflation occurs. Polymer marker bands can be used instead of metal ones in many situations. In order to compete with the radiopacity of platinum iridium, tungsten metal powder is compounded with a similar base resin to the shaft resin, usually at very high loadings. Compounding Solutions have developed a proprietary tungsten powder with an average particle size of less than 1 micron and low oxygen surface defect concentration that is well suited to this application. To support the urgency of changes within the medtech industry, medical device manufacturing companies constantly need new compounds and material technologies.
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REGULATORY UPDATE
Getting personal MPN EDITOR LAURA HUGHES SPOKE TO SOFTWARE GROUP RIGHTPOINT ABOUT THE LAUNCH OF ITS NEW APP WHICH AIMS TO PROVIDE BETTER COMMUNICATION BETWEEN PATIENTS AND CARE PROVIDERS THROUGH THE MEDICAL SOFTWARE.
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ightpoint has recently announced the formalization of its healthcare practice, as well as a new medical software certification, which will enable the company to deliver FDA-approved medical grade software. This will mark the launch of a formally structured healthcare practice. Rightpoint have been working with mHealth tech company, GenerationOne, to create an app that improves communications between patients and care providers. The app is customizable to any condition so, for instance, it might instruct a participant with a low blood sugar reading to drink a glass of juice. Greg Raiz, chief innovation officer, Rightpoint answered some questions prior to the announcement going live on March 25th.
WHY IS THIS ANNOUNCEMENT SO IMPORTANT? We’ve seen an increase in software applications used in conjunction with plastics in medicine. Rightpoint has done work in pre-surgery visualization, as well as created an application for post-surgery monitoring. We believe that medical software applications can improve the patient experience. Rightpoint has been developing marketing websites for many years, but for the first time we can now connect our agency across a larger cross-section of capabilities. This is very relevant for companies making medical devices. We’ve found that as medical devices are getting smaller, more of their technology and functionality is being moved into either mobile devices or onto the cloud. We’ve been developing internet of things devices for years and can now connect those skills and capabilities with our work in medical devices. Our ISO certification allows us to build medical software and we believe
that devices paired with medical software is a trend that’s only going to expand over the next decade. WHAT ARE THE ADVANTAGES FOR OUR READERS? The main advantage is the depth of our capabilities in designing great user experiences. Most companies working on software or medical devices come from manufacturing backgrounds. The Rightpoint approach is grounded in software and agile principles, allowing us to move quickly and build innovative, forward-thinking quality user experiences for medical devices. WHAT DIFFERENCES DO YOU BELIEVE YOU WILL SEE AS A RESULT OF THE CERTIFICATION OF RIGHTPOINT’S NEW QUALITY MANAGEMENT SYSTEM (QMS) BY NQA US? Rightpoint was previously doing some medical work, however we were working within other organization’s QMS systems. This new certification will allow us to utilize our agile design and engineering process to build medical products at a fraction of the time and cost that’s typically found in larger medical device organizations.
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The Rightpoint approach is grounded in software and agile principles, allowing us to move quickly and build innovative, forwardthinking quality user experiences for medical devices.
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REGULATORY UPDATE
identify with me SUMITOMO (SHI) DEMAG, A MOLDING MACHINE SPECIALIST HAS PIONEERED A FULLY AUTOMATED IN MOLD DECORATING (IMD) PRODUCTION CELL. THIS CELL CAN BE USED BY TO ISSUE MEDICAL DEVICES WITH UNIQUE DEVICE IDENTIFICATIONS (UDIS) AHEAD OF THE ENFORCEMENT OF THE EU MEDICAL DEVICE REGULATIONS (MDR).
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n May 26th 2020, the new EU Medical Device Regulations (MDR) which mean that every device or its packaging must be issued with a UDI will be enforced. The IMD production cell hopes to tackle what some in the industry perceive will be a challenging and costly undertaking. Designed predominantly for healthcare, automotive and aerospace manufacturing environments where quality control and traceability are critical, the advance hopes to represent a colossal change in how multiple components are individually issued with a unique identifier. This means that any potential quality defect, which might not be picked up for several months, or even years, can be tracked back to the very day and cycle it was manufactured to achieve item-level traceability and conduct root cause analyses on parts and components. Nigel Flowers, managing director at Sumitomo (SHI) Demag UK emphasizes that authentication of individual components in high liability markets like healthcare requires a fingerprint style approach to traceability. Additionally, labels in the future will need to include two identifiers: A device identifier (DI) that identifies the labeller and the specific version or model of a device, plus a production identifier. This variable portion of the UDI needs to include the given lot or batch number, serial number, date of manufacture, expiry date, etc. Flowers explains, “real-time traceability is about being able to call up data and verify the exact settings used on the injection molding machine when that individual plastic part was made. That’s where connectivity to a Management Executive System (MES) is vital.”
This represents another step towards the Smart Factory for tier 1 to 4 medical device injection molders, offering heightened risk management, mitigation and containment, which enables organizations to respond accurately and rapidly with a targeted recall. To eliminate the risk of the wrong QR code being applied to the medical device component, Sumitomo (SHI) Demag deploys a highly dexterous 6-axis robot to remove each part from the mold. The robot holds the part during the entire time the QR code is etched on at the laser marking station, never releasing until the data has been scanned and stored in the holding data system. “What we have created is a fully automated plastic injection molding and laser marking station that connects and communicates the code back to MES holding system where it reconciles up with the machine processing data. In addition to boosting traceability, this synchronized data gives production managers greater visibility on product cycle times and quality,” adds Flowers. Process data that’s recorded includes the exact production date and time, the injection and dosing time, melt cushion, injection pressure and temperature. This enhanced traceability aims to enable organizations to respond more effectively should a defective medical device part or component enter the value chain. Flowers comments, “it’s becoming increasingly imperative to limit operational risk exposures with targeted rather than mass recalls. Real-time traceability provides the means to limit recall exposure by improving end-to-end process transparency.”
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MPN_HP_chain_04.2019_pdfx1a.pdf 1 4/15/2019 12:41:03 PM
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BIOMEDEVICE
A recipe for success BIOMEDEVICE IS DESCRIBED AS NEW ENGLAND’S PREMIER MEDTECH EVENT, AND IT HOPES TO BRING TOGETHER TECHNOLOGY AND PRODUCT DEVELOPMENT BEST PRACTICES FOR SUCCESSFUL INNOVATION.
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he BIOMEDevice event will be held in Boston Convention and Exhibition Center, Boston, Massachusetts between 15th and 16th May 2019.
The event is anticipating attendance from over 3,300 industry professionals and aims to update attendees on topics such as design engineering, biomedical innovation, and software capability. The conference is designed for engineers, managers, and executives who are seeking solutions to help them turn concepts into competitive products. All attendees will have the opportunity to attend tech sessions, panel discussions, and case study presentations. There will also be the chance to hear from both established companies and start-up companies as they outline new strategies to speed products to market. In terms of exhibitors, there will be over 375 this year. This includes big industry names such as Accumold, BMP Medical, Nelson Laboratories, Qosina and many more. Last year, attendees from leading medtech companies joined the conference delegation. Some examples of these companies were; Boston Scientific, FDA, Johnson & Johnson, Medtronic and Siemens Healthcare.
THERE WILL BE TWO MAIN TRACKS AT THE EVENT: • Product development – Focusing on user-centered design strategies, product innovation with robotics and artificial intelligence (AI), risk management and scale-up approaches and regulatory strategies • Research and development – Focusing on sensors, bioelectronics, AI, and robotics, biomaterials and biocompatibility, productivity tools and advice, research funding strategies. Additionally, there will be more than 60 speakers talking at the function. This includes two expert key-note speakers; Scott Huennekens and Kevin Blankespoor. Huennekens, founding CEO of Verb Surgical will discuss medtech 4.0 and how the intersection of robotics, AI, and medical devices could change the future of care. Huennekens will also provide insight in to what he believes all medtech professionals need to know about these topics. Blankespoor, vice president of product engineering at Boston Dynamics, has spent years transitioning robotic prototypes into functional products. Blankespoor will discuss the different working applications for mobile robots within the real world, alongside a live demo of the Boston Dynamics robot, Spot. It is worth highlighting that the one expo pass gives you access to all of the following three shows; BIOMEDevice Boston, Design & Manufacturing New England, and Embedded Systems Conference (ESC) Boston. In order to keep up to date with the event on social media, follow the hashtag #AdvMfgExpo.
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Five reasons to head to MD&M East 1
EXHIBITORS: Many of the major companies involved in medtech will be exhibiting at the event
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MULTIPLE SHOWS: One expo pass will provide you with access to six different trade shows
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AWARDS: The event will host the prestigious Medical Design Excellence Awards
RESEARCHERS IN CHINA HAVE EQUIPPED A 3D PRINTER WITH A COAXIAL SPINNERET
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ccording to a scientific paper published in the journal Matter, this development enables 3D printers to print flexible fibers that can harvest and store electricity on to fabric. This idea therefore hopes to expand the possibilities for wearable technologies. Professor Yingying Zhang, department of chemistry, Tsinghua University, China who was involved in the research said: “We hope this work will inspire others to build other
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types of 3D printer nozzles that can generate designs with rich compositional and structural diversity and even to integrate multiple coaxial nozzles that can produce multifunctional e-textiles in one step. “Our long-term goal is to design flexible, wearable hybrid materials and electronics with unprecedented properties and, at the same time, develop new techniques for the practical production of smart wearable systems with integrated functions, such as sensing, actuating, communicating and so on.” This method removes the need to manually sew electrical components on to fabrics and is advantageous as it is inexpensive and easy to scale. Additionally, the nozzle can be implemented in to the previous routine with ease as it is able to be used with existing 3D printers.
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HOT TOPICS: There will be a medtech showcase covering a wide range of trending topics
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MOBILE APP: Launched closer to the time, this will ensure you get the best out of the event
a sound invention
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sing 3D printing, Elen Parry, designer of HeX earbuds and a student at Manchester Metropolitan University has created a hearing aid which aims to allow people to take control of their hearing. This was highlighted during the recent Industry 4.0 Summit & Expo in Manchester, United Kingdom. Through the use of a processing chip, these earbuds offer users the ability to differentiate between background noise and the noise they want to hear. The user is able to adjust the volume of background noise as appropriate.
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There is also embedded technology which allows the user to participate in activities that weren’t previously possible such as streaming music and taking phone calls. This can be done by attaching a regular silicone earbud to the hearing aids. A rechargeable graphene battery is also inserted into the product with dual connectivity strips for faster charging. Additionally, the earbuds look attractive and discrete. “I looked into designing something that could create an improved situation for everyone, rather than a niche for people who are seen as less abled,” said Parry.