MPN EU Issue 47 by MPN Magazine

EUROPEAN EDITION

MEDICAL PLASTICS news

How soft-skin adhesives are supporting the wearables trend

MED-TECH INNOVATION EXPO RECYCLING MEDICAL DEVICES KEY CONSIDERATIONS IN ORTHOPAEDICS

ISSUE 47

Mar-Apr 2019

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CONTENTS Mar-Apr 2019, Issue 47

Regulars

Features

3 Comment Laura Hughes discusses patient involvement in healthcare

19 A leading acquisition Brian Lambton discusses Corin’s entrance in to the orthopaedic robotic market

39 The small print Queen’s University Belfast has invested in a 3D bioprinter from GeSiM

27 Material movement NuSil’s Brian Reilly highlights options for reducing friction when using silicone elastomers

46 Plastics: More than straws and cotton buds Ole Grøndahl Hansen, PVCMed Alliance, explains how plastics have paved the way for significantly longer lives

6 News focus New portal hopes to ease transition to new medical device regulations 8 Digital spy 13 Analysis MedPharmPlast Europe’s membership continues to rise 15 Analysis The growing success of Pharmapack explained 16 Cover story The challenges associated with medical wearable technologies

31 Sign of the times Jeanette Kusel, director for NICE scientific advice announces the launch of a new module of the META tool 33 Supply versus demand Compounding Solutions highlights technologies such as ReZilok

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EDITOR’S

group editor | dave gray head of content | lu rahman contributor | reece armstrong assistant editor | ian bolland advertising | sarah livingston sarah.livingston@rapidnews.com head of media sales life sciences & plastics | lisa montgomery head of studio & production | sam hamlyn graphic design | matt clarke publisher | duncan wood Medical Plastics News Europe Print Subscription – Qualifying Criteria UK & Europe – Free US/Canada – £249 ROW – £249 Medical Plastics News NA Print Subscription – Qualifying Criteria US/Canada – Free UK & Europe – £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.

BPA Worldwide Membership ISSN No:

2047 - 4741 (Print) 2047 - 475X (Digital)

We need to react to the rise of patient involvement in their healthcare

about the public’s right to know this information.

A keen scientist, my background is heavily chemistry focused. I have a Master of Pharmacy degree, and have spent my entire career working in medical publishing, specialising in cardiology and ophthalmology.

The patient’s needs are however being addressed in the medical device industry through the use of innovative devices such as the AWAK PD device. This device allows dialysis for renal diseases to be conducted whilst the person treated is able to continue their daily life; preventing them being subject to hours in a hospital or treatment centre.

am delighted to be the new Editor for Medical Plastics News.

My background in pharmacy means I’ve always been interested in the patient’s voice, and I believe this is something that is becoming increasingly prominent. It was recently reported that 90 companies to date have pledged to the Patient Safety Movement Foundation (PSMF), which aims for zero preventable deaths in the future. The PSMF addresses healthcare technology within their mission. Whilst significant progress towards eliminating preventable deaths is being made, there may be a longer way to go than we think with regards to transparency. An example of a failure to disclose information was recently brought to light in the news, where a repository of hidden FDA reports was made public, with one device of mention being surgical staplers. It was stated that the makers of surgical staplers had been privately granted an exemption, meaning that any reports of malfunctions were in a database not visible to physicians or the general public. A former FDA official spoke out

I believe we are making giant steps in acknowledging the patient’s voice in this industry, and that patient involvement will only increase with time.

I am looking forward to learning more about the patient’s role, and the most recent advances in the plastic medical device sector. At a time where more patent applications were filed by European Companies in 2018 than the previous year, I know I have chosen a very exciting time to join this magazine. I’m pleased to say I will be joining my colleagues from our sister title, Med-Tech Innovation News, at the Med-Tech Innovation Expo, taking place at the NEC, Birmingham, UK, 15-16 May. I look forward to meeting you there and learning more about your current projects. You’ll find all the information you need about this year’s Expo in this issue.

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NEWS FOCUS

Making the change THE EUROPEAN COMMISSION ANNOUNCES ITS NEW PORTAL WHICH AIMS TO AID THE TRANSITION TO NEW REGULATIONS REGARDING MEDICAL DEVICES.

he recently launched medical devices section on the European Commission’s website has been revamped to help the smooth transition to the two new regulations on medical devices and in vitro diagnostic medical devices. The portal presents the new regulatory requirements in various sections targeted at impacted actors such as manufacturers, importers, health institutions, and authorities in non-EU countries. The new EU Medical Devices Regulation (MDR) 2017/745 and the EU In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746 bring EU legislation in line with technical advances, changes in medical science, and progress in law making. The revamped website explains the main differences between the current directives and the new regulations and highlights the timeline for the transition along with deadlines for implementation. The new portal also offers resources targeted at journalists interested in the medical industry, including factsheets explaining the impact of the regulations on stakeholders across the sector, FAQ that shine light on technical aspects of the regulations and a contacts page through which journalists can request additional information.

At the launch of the portal, Elżbieta Bieńkowska, commissioner for internal market, industry, entrepreneurship and small and medium-sized enterprises, said: “With the new regulations, Europe introduces robust rules that improve clinical safety and create fair market access. The new website will help ease transition to the new regulations for all stakeholders in the medical devices and in vitro medical devices ecosystem.” The MDR will replace the existing Medical Devices Directive (MDD) 93/42/EEC and the Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC. The MDR was published in May 2017, marking the start of a 3-year period of transition from the MDD and the AIMDD. The IVDR will replace the existing In Vitro Diagnostic Medical Devices Directive (IVDD) 98/79/EC. The IVDR was published in May 2017, marking the start of a 5-year period of transition from the IVDD. In contrast to directives, regulations are directly applicable and do not need to be transposed into national law. This means the regulations should lower the risk of discrepancies in interpretation across the EU.

The new regulations will aim to improve the quality and safety of devices on the EU market. In particular, they will reinforce the criteria for the designation of notified bodies and processes for their oversight, introduce stricter pre-market control of high-risk devices and strengthen post-market surveillance. One of the main new features of the regulations is a completely new system of unique device identifiers (UDIs), which hope to improve the identification and traceability of medical devices. It will try to create a system to uniquely identify medical devices along the supply chain. The new regulations will also aim to increase transparency. Summaries of safety and clinical performance for high risk medical devices will be publicly available via the European database on medical devices (EUDAMED). The database will include information on devices, economic operators, clinical research and post-market surveillance. EUDAMED will help regulatory authorities coordinate and exchange information and will be used to report and track incidents.

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DIGITAL SPY

3D PRINTING

DIGITAL

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OFFERS AMPUTEES TOTAL LEG SOLUTION DEVICE UPDATE

pecialist prosthetics company UNYQ has launched a 3D-printed prosthetic leg socket to offer amputees a total and personalised leg solution. The company’s UNYQ Socket has been developed to complement users’ prosthetic leg covers and is one of several additional products to be added to the company’s prosthetic wear line. The UNYQ Socket gives users an aesthetically appealing, lightweight product that does away with much of the metal normally used in traditional prosthetic legs. More so, the socket contains sensors that records the individual’s activity, including number of steps and calories burnt. Clinicians benefit from this access to data and the ability to easily replicate the product. Since many amputees have more than one prosthetic leg, replication of the socket at the press of a button can save multiple clinical visits. Manuel Boza, co-founder and VP of prosthetics at UNYQ,

www.mit.edu

new device could transform tb treatment

new drug delivery device developed by researchers at the Massachusetts Institute of Technology (MIT) could transform the way patients with tuberculosis take antibiotics. Currently, treating TB requires patients to take a six-month course of daily antibiotics, a treatment regime which is difficult to adhere to, especially for those with limited access to medical facilities. As one of the world’s deadliest diseases, TB kills over 1 million people every year and is thought to have infected over a quarter of the global population. Now, in an effort to reduce healthcare costs and cure more patients, the MIT team have developed a device that slowly releases antibiotics over the course of a month, eliminating the need for patients to take pills every day.

‘

The device consists of a coiled wire loaded with antibiotics which is inserted into the patient’s stomach through a nasogastric tube. The device is made out of an alloy of nickel and titanium that changes shape based on temperature. This means that once in the stomach, the wire transforms into a coil to prevent it passing further into the digestive system. During tests in pigs, the team found that their prototype device could release several different antibiotics at a constant rate for 28 days. “The current model for TB treatment is directly observed treatment, short course, where the patients have to come in every day and have somebody watch them take their pills. That’s a huge burden, for the patients and the healthcare system,” said Malvika Verma the study’s lead author.

said: “We are thrilled to announce the launch of the UNYQ Socket today. This is another step forward in being able to provide amputees with a total leg solution. A solution where it’s practically one component, rather than a mish mash of different elements bolted together. We are working hard to further develop our prosthetics wear line, as well as the other exciting medical wearables in our pipeline, to continue to support our end users.”

MEDTECH UPDATE www.ahsnnetwork.com

Report accelerates spread of UK medtech

new report has launched by the Academic Health Science Networks (AHSNs) and the Association of British HealthTech Industries (ABHI) to accelerate the entry, adoption and spread of medtech innovations for the benefit of patients and commercial success. The report identifies that despite improvements in national policy to support the medtech sector, there is a need for practical advice to help the industry thrive. Specifically, in the NHS an integrated approach is necessary to support medtech innovations, including checklists and practical steps for each aspect of the pathway, including creation, development, regulation, evaluation, market access, commissioning and adoption. The report also highlights the support AHSNs can offer through the Innovation Exchanges operated by each of the 15 regional AHSNs. These link innovative solutions with

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existing local healthcare system challenges to help ensure that the local needs of the sustainability and transformation partnership and Integrated Care Systems are met. Richard Phillips, director of healthcare Policy, ABHI, commented: “The potential of cutting-edge technologies to support preventative, predictive and personalised care is huge, and the UK has the chance to lead the world.”

DIGITAL SPY

DEVICE UPDATE

www.sniffphone.eu

SniffPhone prototype enables the diagnosis of early stage gastric cancer

TT, a visionary research, development and innovation partner has aided the development of the SniffPhone prototype and concept with nine other project partners. SniffPhone, a device which is currently in its prototype phase, enables the early diagnosis of gastric cancer from a person’s exhaled breath. VTT claim that his new method could revolutionise cancer screening all over the world by providing a simple, fast and cost-effective alternative for screening gastric cancers. SniffPhone is a small sensor device developed for cancer screening that can be attached to a smartphone. It can be used by holding the device in front of your mouth and exhaling onto the sensor to provide a breath sample. The device measures the contained Volatile Organic Compounds (VOCs) using

highly sensitive nanotechnology-based chemical sensors. The measurements are then sent via bluetooth using a smartphone to a dedicated cloud platform, where they are analysed by the appropriate medical personnel. VTT’s role in the project was the implementation of the platform for transferring data from the smartphone to a cloud-based storage space. VTT has also been building analysis tools and methods for recognising high-risk patients, and VTT has developed a mobile application that guides the user in giving a breath sample and provides the user with a preliminary analysis of the sample. Furthermore, a physician’s analysis tool has been developed to display the analysis results of breath samples. VTT was also in charge of the implementation of responsible research and innovation in the project by such methods as engaging final users and stakeholders in the development work through interviews and workshops and integrating responsible design practices into project operations. The SniffPhone project is part of the EU’s Horizon 2020 Funding Programme, and on 21st November 2018, the SniffPhone project was awarded the 2018 Innovation Award by the European Commission for Most Innovative Project.

AM UPDATE

ADDITIVE MANUFACTURING’S POTENTIAL FOR SPINAL IMPLANTS www.renishaw.com

lobal engineering company Renishaw has collaborated on a project with two advanced technology companies to streamline the transition from design to additive manufacturing (AM) in the production of spinal implants. Renishaw worked with Irish Manufacturing Research (IMR) and nTopology to show how streamlined the transition from design to AM can be when working with the right partners. IMR designed a representative titanium spinal implant, aimed at the cervical spine using nTopology’s generative design software. IMR then manufactured the implants using Renishaw’s RenAM 500M metal AM system. Patients that require spinal implants to restore intervertebral height can benefit from an improved implant design made

possible by AM. In particular, patients may require shorter surgery time and fewer revision surgeries, saving healthcare resources and costs. “AM can be used to manufacture spinal implants with lattice structures, which cannot be achieved with conventional manufacturing techniques,” explained Ed Littlewood, marketing manager of Renishaw’s Medical and Dental Products Division. “An implant with a lattice structure is lightweight, can be optimised to meet the required loading conditions and has a greater surface area, which can aid osseointegration. Therefore, AM implants can be designed to mimic the mechanical properties of bone, resulting in better patient outcomes. But all of this comes to nothing if you do not have the tools to create the design.”

talking

POINT

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New pressure sensors could spell big news for medical device OEMs All Sensors has announced a new line of digital pressure sensors: the ELVR series, which could be big news for medical device manufacturers. What’s the new product and what’s it for? The ELVR product family is a modular platform of pressure sensors designed for respiratory applications and similar medical equipment. Depending on calibration it can either be used as a conventional pressure gauge or as a flow meter as well. Its low power consumption makes it an ideal choice for battery powered mobile devices and the various housing configurations available make it an easy fit to most devices. Why is it valuable for the medical device industry? Designed from the beginning with handheld devices in mind, the ELVRs compensation technology significantly reduces measurement errors by external interference such as acceleration or rapid temperature changes. For example, this enables medical device manufactures to make emergency care equipment even more robust and reliable when working in harsh environments. The advanced signal conditioning is all digital which makes the product configurable for application specific requirements. At the same time the digital interface makes integration with existing hard- and software easier. What’re the big trends in sensors for medical applications? More and more sensors being used in applications that didn’t use any measurement devices in the past. Thus, sensors help in making medical devices smarter and treatment safer and more comfortable for the patient.

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NEWS ANALYSIS

BUG OFF CAMSTENT’S CE MARKED POLYMER COATED CATHETER WHICH PREVENTS BIOFILM ATTACHMENT, RECEIVES POSITIVE RESULTS FOR ITS FIRST IN-HUMAN PILOT STUDY.

K-based Camstent, which applied proprietary bacteriaphobic polymer coatings to medical devices, has received the initial results from the first inman pilot study for its CE marked, coated catheter. Camstent believes that the initial results from the first in-human pilot study could pave the way for a novel approach in the fight against super-bugs. The Camstent coated Foley Catheter is intended for the drainage of urine from the urinary bladder. Camstent claims that the coating enhances lubricity, and thus significantly reduces insertion force. The results, which compared 10 Camstent coated catheters and 12 uncoated silicone catheters, showed a clear reduction of biofilm formation and biomineralisation on the Camstent polymer coated catheters compared with uncoated catheters. Camstent claims that the results collected are very encouraging for the battle against catheter-associated urinary tract infections. To support this initial evidence, future comparisons of greater numbers of catheters, the performance of coated catheters over longer time periods and more detailed microbiological investigations will be required. Catheter-associated urinary tract infection is one the major causes of

hospital acquired infections (HAI) and accounts for 38% of all causes. HAI can lead to longer stays in hospitals for patients, can seriously endanger health and lives, and currently costs the NHS one billion pounds every year. The 22 coated and uncoated samples obtained from patients catheterised for bladder management after urethral reconstructive surgery, were allocated non-randomly. Once removed they were analysed by scientists at centre for biomolecular sciences and school of life sciences, and the school of pharmacy at the University of Nottingham. The results from the pilot study are being presented this week by clinical researchers from University College London Hospitals NHS Foundation Trust in a poster titled “A new bacterial resistant polymer catheter coating to reduce catheter associated urinary tract infection (CAUTI): A first-in-man pilot study”, at the 34th Annual European Association of Urology Congress in Barcelona and the International Meeting on Reconstructive Urology, Hamburg. The polymers used in the coating were originally reported to have bacteria-phobic properties and were discovered at the University of Nottingham in 2012. Since then they have been developed by Camstent into a silky-smooth coating for silicone or siliconebased medical devices. Unlike other coatings that are designed to kill bacteria adhering to the surfaces, Nottingham’s passive non-stick molecule within Camstent’s coating aims to deter bacteria from attaching to the catheter surfaces at all. This novel approach has now been demonstrated to reduce formation of biofilm that, in turn,

can lead to infection. It has the added advantage of no potential of creating antibiotic resistant organisms or super-bugs. Dr Dave Hampton, founder and CTO of Camstent, said: “While our catheter was approved for use in patients last year for its silkysmooth texture, this is the first time we have evidence that our coating acts well in preventing biofilm attachment in humans. These initial results are being corroborated by over 60 cases as we expand the number of settings taking part in trials. We are looking to grow the body of evidence to support these initial results and welcome anyone interested in conducting trials to contact us.” Daniela Andrich MD MSc FRCS, Honorary Associate Professor, Division of Surgery and Interventional Science, UCL, who has been conducting the pilot study, said: “Our patients are at high risk of post-operative catheter related wound infection and we are very pleased that there is, finally, a non-antibiotic based catheter that aims to protect the patient and has no risk of antibiotic drug resistance. The surface of the catheter is very smooth and hardly requires lubrication for insertion or withdrawal, which is great for the patient. We will continue to evaluate Camstent catheters in our reconstructive urology practice.”

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NEWS ANALYSIS

STEVE DUCKWORTH DISCUSSES THE MEMBERSHIP OF MEDPHARMPLAST EUROPE, AND HOW THE EXPANSION HOPES TO PROVIDE A MORE INFORMED AND UNIFIED VOICE IN EUROPE.

Steve J. Duckworth, global head of healthcare polymer solutions at Clariant and MedPharmPlast Europe president

he market in plastic medical devices and pharmaceutical packaging continues to grow, and plastic is at the heart of delivering innovation in this market. The industry faces numerous challenges, including important and complex changes in the European legislation, the increasing need to get information through the whole supply chain in an efficient manner, as well as global markets and varying regulatory requirements, to name just a few. Many of these regulations have, at their base, the need to better characterise and control the plastic materials that interact with the patient, the drug, or influence reliability of devices. Established in 2014, MedPharmPlast Europe (MPPE) brings together experts, creating well-informed and effective advocacy representing the whole value chain: from plastics producers to medical device manufacturers and pharmaceutical packaging manufacturers, and those involved in testing materials and final products at the European level. MPPE is the voice of the entire value chain of plastic medical devices and pharmaceutical packaging in Europe. The association represents the interest of these industry groups and interacts with the European Institutions to support the delivery of final regulations workable for the industry whilst protecting patient safety.

MPPE President Steve J. Duckworth (global head of healthcare polymer solutions at Clariant) knows exactly why this European wide industry collaboration is so important: “Our industry is confronted with several regulatory challenges, it is essential to get the entire value chain aligned in order to address the issues with one voice. The outreach of MPPE has been growing constantly over the past years. We hold regular meetings with the European Commission and European associations or platforms such as MedTech Europe, and the European Chemicals Agency (ECHA). This shows the increasing importance of our group for our members.” MPPE holds two major events on a yearly basis. In summer, a public two-day conference focusing on regulatory topics from a European and global perspective held in changing European cities – often in combination with site visits. In November, all MPPE members get together for the Annual General Assembly as well as an internal conference with expert speakers for members and invited guests. “The high-level speakers and increasing numbers of participants at our events, show that MPPE is a serious player in Brussels offering added value to the European supply chain of plastic medical devices and pharmaceutical packaging. In July 2018, we brought together more than 50 industry experts in Lyon for our Summer Conference “Material Characterization & Risk Assessment” to discuss changes to the ISO 10993

set of standards, EU and US Pharmacopeia, the Medical Device Regulation, the VDI 2017 MedicalGrade Plastics Guidelines, and much more”, concluded Duckworth. At the heart of MedPharmPlast Europe is its regulatory taskforce with its technical, regulatory and monitoring activities for the association members. Through close collaboration with EU institutions and engagement with EU regulators and other decision-making bodies, this group supports the development of more sustainable medical devices and packaging solutions and helps its member to address emerging issues related to this sector. Additionally, it provides a forum for members that wish to contribute directly to the positions and activities of MPPE. The regulatory taskforce is chaired by Nigel Talboys, global director of government affairs and public policy at Terumo. MedPharmPlast Europe has been successfully expanding its membership from the entire value chain leading to a more informed and unified voice essential for members and the industry.

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NEWS ANALYSIS

IT'S HOW YOU PACKAGE IT AT PHARMAPACK 2019, THE INTERPLAY BETWEEN PHARMA AND MEDTECH WAS MORE EVIDENT THAN EVER. REGULAR CONTRIBUTOR REECE ARMSTRONG CAUGHT UP WITH SILVIA FORROOVA, EVENT DIRECTOR OF PHARMAPACK TO FIND OUT WHY.

he meeting takes place outside of one the venue’s conference rooms, situated a few stories up and boasting an impressive view of Paris, the Eiffel Tower clearly visible. Being 11.30am the show has barely begun, but already the show floor is packed and stands are streaming with visitors. Forroova begins by commenting on the success of the show and why it is expanding at such a rate. “It’s actually expanding because of how the markets are developing. If we think about the pharma market in terms of innovation; what is happening when it comes to serialisation, biological drugs, containment, the technology being used in wearable devices, and prefilled syringes are a huge topic as well. All of these factors are trying to minimise healthcare costs more so than ever before,” Forroova says. While innovation seems to be a key driver of the show and indeed the industry, increased collaboration between medtech and pharma appears to be equally as important. The latest Pharmapack report for instance indicated how larger companies are now looking to acquire SMEs to boost approval times and scale-up challenges. On the topic of collaboration, Forroova believes that changes to drug development have led to packaging being considered much earlier in the lifecycle of a drug. “Packaging used to come in quite late in the stages when it came to drug development. Or even at the final stage. We have a pill, we have a product and it needs packaging somehow. It needs a box!” she jokes. Now though Forroova relates the rising complexity of drug molecules to a specific need in the way they’re packaged, tracked and labelled. The obvious contender for change in this instance is the Falsified

Medicines Directive (FMD), which came into effect in February. The FMD requires pharmaceutical companies to comply with a number of safety features that ensure the authenticity of medications throughout the entire supply chain, limiting the possibility of counterfeit medicines and devices making it to the patient. Asked whether patients are aware of the dangers of counterfeit products, Forroova thinks that this varies depending on the country. “In Europe and the US more people are aware of counterfeit drugs and products. When it comes to patients, it’s more about making sure they never have to think about counterfeit medicines; that products aren’t safe to use or have had to be recalled. I think that’s our role here, to educate manufacturers and the packaging companies to do their utmost and to support the activities they’re planning,” she says.

delivery devices to new kinds of easy-to-open blister packs. One of the most unassuming products we discuss is a glass vial that has an invisible UV print on it, which provides an anti-counterfeiting aspect to the packaging. It’s simple but wholly intuitive and is one of the best examples of how even the most modest products are changing to industry needs. “I think it really shows us the trends and how we’re trying to showcase players and an industry that is actually supportive on innovation. So this is very important, this is our mission and vision,” Forroova concludes.

We briefly touch on the subject of Brexit, and whilst Forroova doesn’t want to stray too far into political waters, she understands that the UK’s departure from the EU could produce a sort of sea change within the industry.

When it comes to patients, it’s more about making sure they never have to think about counterfeit medicines.

While Brexit isn’t something Forroova delves too deeply on, she doesn’t deny that it is firmly on the minds of visitors and exhibitors to Pharmapack; there’s even a conference session devoted to it. However, she’s right to say that it isn’t the show’s main focus, which she thinks is clearly represented by Pharmapack’s Innovation Gallery. Showcasing the industry’s latest advancements, Pharmapack’s Innovation Gallery constitutes everything from connected drug

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COVER STORY

Wearing it well AS THE MEDICAL FIELD UNDERGOES ITS TRANSFORMATIVE LEAP INTO A DATA-DRIVEN LANDSCAPE, THE ONGOING EMERGENCE OF MEDICAL WEARABLE TECHNOLOGIES POSE INTERESTING AND SOMETIMES FORMIDABLE CHALLENGES TO DEVICE DESIGNERS, AS STEPHANIE STEICHEN, TECHNICAL SERVICE AND DEVELOPMENT SPECIALIST, DUPONT EXPLAINS.

he device attachment can oftentimes be overlooked as a critical parameter in overall device performance, function, and user experience. Although devices can be attached by clips, belts, or clothing, the comfort, ease, and flexibility provided by adhesive securement is typically preferable. The selection of an adhesive, therefore, is an additional and important criteria to consider early in the design of a wearable medical device. Silicone adhesives have unique material properties and versatile chemistry that enables their use in medical device attachment. When compared to alternative adhesive offerings, silicones provide the necessary adhesion to securely affix dressings and devices with a non-sensitizing, non-irritating, highly breathable, and skin-friendly formulation. There are two primary families of nonbonding silicone adhesives: soft skin adhesives (SSAs) and pressure sensitive adhesives (PSAs). The SSAs are lightly crosslinked silicone elastomers that form a soft, tacky gel, which has gentle

adhesion to injured skin for scar/wound care applications. PSAs are a polycondensed polydimethylsiloxane/silicate resin network with higher adhesion levels recommended to firmly attach devices to healthy skin. Within each adhesive family there is a wide range of available adhesion levels and additional properties that can be tailored for the needs of a given application. The selection of an appropriate adhesive requires the consideration and understanding of several critical parameters, which will, to varying degrees, affect the adhesive performance and, ultimately, the wear of the device. These parameters can be broadly classified into two categories: unmodifiable and modifiable. The unmodifiable parameters are the inherent properties of the skin, the user, and the intended application that will have an impact on wear, but cannot be manipulated in a significant way. Conversely, the modifiable parameters, such as adhesive material properties and dressing design, will also have an impact on wear but can be controlled and altered by the designer. UNMODIFIABLE PARAMETERS Skin physiology – The interaction between the adhesive and the substrate upon which it is adhering is critical. In other applications, tight control and consistent preparation of the substrate is of vital importance to form the adhesive bond and, consequently, to final performance. The skin, however, is a dynamic and highly variable substrate, which provides a challenging surface upon which to adhere. The composition of the skin can vary significantly between individuals and also between different locations on the body. Factors such as hair density, oil/sebum production, sweat glands/production, and moisture levels will modify the skin’s surface and affect the interaction with the adhesive. These surface irregularities may potentially disrupt the non-covalent bonding of the adhesive to the skin and negatively impact wear. This variability can be further amplified by disease state. Numerous diseases affect the health, integrity, and overall condition of the skin. The presence of wounded skin can complicate wear, as it may modify the mechanical properties of the skin, introduce extraneous biologic fluids, and prevent aggressive solutions that could further injure the area. User type – The age, activity level, and general health of a device user can have drastic effects upon the wear of an adhesive/device. A healthy and active user will inherently place more demands upon the adhesive than someone bed-ridden. These adhesives are not covalently bound to the surface of the skin and instead rely on a combination of intermolecular interactions to remain adhered. There is a limit, therefore, of how much force these bonds can withstand before adhesive failure occurs. Movement of the skin under the adhesive is unavoidable, but the amount and frequency will impact the wear duration. Application/Use – In certain use cases, the location of the medical device cannot be adjusted. For example, an ostomy pouch must be repeatedly placed over the stoma, which stays in the same location. This prevents the designer, or user, from adjusting the device to a more comfortable position unperturbed by clothing and free of other surface irregularities or contaminants.

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Although the above parameters provide a challenging set of conditions to work around, between the adhesive selection and device design, the designer has a host of modifiable parameters with which to adjust wear and device performance. MODIFIABLE PARAMETERS Adhesive design Chemistry and rheological properties – The chemistry and rheological properties of the adhesive control its propensity and subsequent ability to interact with the surface of the skin – a relatively non-polar and hydrophobic substrate. The chemistry dictates the types of intermolecular interactions, e.g. hydrogen bonding, van der Waals forces, etc. that can occur, while the rheological properties facilitate the intimate contact required for these interactions to occur. It is thought, for example, that PSA adhesion is driven by moieties containing hydrogen bonding acceptor and donor sites being placed in intimate contact with the contours of the skin by way of its flowable, thermoplastic nature. SSAs, although thermoset, allow for the same intimate contact due to their soft, gel-like structure. Based upon the application, the base and cure chemistries can be carefully selected to obtain the distinct adhesive families, i.e. thermoplastic or thermoset, and to further refine the desired material properties, e.g. cohesion, adhesion, softness, etc., which can impact wear. Although complex, a robust adhesive design is an important consideration that can significantly improve overall device performance. Permeability – The adhesive’s permeability to gas and moisture will affect both wear and user comfort. An occlusive dressing has the potential to cause irritation and could, if severe enough, have a deleterious effect on skin integrity and health. While silicones are highly permeable to gases, they are less permeable to liquid water due to their hydrophobicity. In regions of the body with higher moisture, such as the armpit, on active users, or in humid climates, the wear can be negatively impacted due to moisture accumulation under the dressing. The introduction of perforations in the silicone dressing can mitigate these effects and improve wear. Device design – The device design includes the selection of the adhesive, but also its overall construction. An increase in adhesive surface area, an increase in adhesive thickness (for SSAs), and a decrease in device weight should all increase device wear. By maximising the ratio of adhesive surface area to device weight, one should theoretically improve wear. This is with one caveat, however, that the thicker the silicone adhesive, the lower the permeability and the more occlusive the attachment, which could negatively impact wear and user comfort. The occlusivity of the device component should also be a consideration. The location of device attachment is also critical. Large surfaces with flatter contours, such as the chest and abdomen, that are less likely to be accidentally perturbed will provide the most desirable surfaces for wear. If surfaces with more substantial curves, such as the arms, are utilized, the device must be flexible enough to conform to the contours or be designed to otherwise accommodate the contours. This is to ensure the intimate contact required for good adhesion and wear. The wear of a device on the skin is a complex interaction that is affected to varying degrees by numerous modifiable and unmodifiable parameters. A balance must be struck in every device design between these two classes to maximise wear, user comfort, and device performance.

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13/03/2019 16:57

ORTHOPAEDICS

A LEADING ACQUISITION MEDICAL PLASTICS NEWS GROUP EDITOR DAVE GRAY SAT DOWN WITH BRIAN LAMBTON, CORIN’S GLOBAL PROFESSIONAL EDUCATION MANAGER, TO DISCUSS CORIN’S ENTRANCE IN TO THE ORTHOPAEDIC, ROBOTIC MARKET FOLLOWING ITS ACQUISITION OF US SURGICAL ROBOTIC FIRM OMNI.

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 orthopaedics 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 Orthopaedic Technologies (GOT). This is how we began our relationship with OMNI Orthopaedics Inc.” OMNI’s proprietary robotic platform, OMNIBotics, allows surgeons to conduct patientspecific total knee surgery, and designs, engineers, manufactures and distributes a wide range of proprietary hip and knee implants. Stefano Alonsi, Corin’s CEO expressed his delight at the combination of OMNIBotics for the knee and Corin’s Optimised 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 organisation 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 maximise the potential of our robotic solutions, adding another unique technology to their ecosystem.”

This acquisition was not the first for the company, with them purchasing Australian company, Optimised Orthopaedics, the owners of OPS technology in 2013. This technology was, “designed to look at patients on an individual basis and look at how their bones moved within their bodies,” 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.” Lambton went on to mention how, “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 need. You can then make all of the cuts that you require via robot technology.” This is more preferential than using individual cutting blocks, as Lambton explains, “you can simply pin the robot to the patient’s leg, and it does all the cuts in one go from there.” This imageless knee replacement combines a robotic cutting guide with the world’s first robotic tool to measure ligament function. 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 orthopaedics. He went on to state how, “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 Lambton informed was very bad for polyethylene.

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ORTHOPAEDICS

However, Lambton explained that the way in which we eliminate the free radicals that are left behind has changed. “Previously, the challenges were that either the material is somewhat weak, or you have a material that still has some free radicals in it which are able to oxidise. When this material is put in to the human body, oxygen is dissolved within tissues, and that oxygen can then get in to the polyethylene. “If we can control the cross linking process, we can reduce the wear of polyethylene significantly. Following this revelation, joint replacement length is now expected to be much longer.” He went on to refer to some data from the World Health Organisation which had suggested that if you were a female who had lived up to 50 years old and lived in the first world, you had a 50:50 chance of living to be 100 years old. Lambton raised the issue that, we are operating on some of these people in their 40s and 50s, and therefore what is the expected life expectancy for these people?

Lambton concluded, “there is a lot of discussion going on at the moment about getting it right first time, because if we can get the procedure right the first time then the hope is, that we would be doing it once and the patient would not have to return to the operating theatre again.” Everything Corin are doing is aimed at combining the very latest technology with the best in material science to achieve the best outcome. Their strategy is to revolutionise orthopaedics and OMNIBotics, combined with APEX knee replacement aims to do this.

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. In order to make this, “we mix the vitamin E in at the front before it’s consolidated, so it’s very homogenous. We then highly crosslink it with a large dose of radiation to ensure the same level across the material, and then we use a mechanical process to eliminate all the free radicals without eliminating the properties of polyethylene.” In Lambton’s words, “We hope this is the Holy grail of polyethylene. “The key is if you don’t get the implants in the right place, then it doesn’t matter how good your materials are, they will still fail under poor mechanical positioning of the implant.” “This acquisition will allow us to very precisely place those implants accurately for the individual patient, so it will last longer. What you are looking for is a long length of clinical survivorship, but also high levels of patient satisfaction.”

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We expect Corin to remain at the forefront of development in robotics and computer-assisted surgery.

SENSORS

Better baby bonding A pair of soft, flexible wireless sensors have been developed to replace the tangle of wire-based sensors that currently monitor babies in hospitals’ neonatal intensive care units (NICU) and pose a barrier to parent-baby cuddling and physical bonding. The interdisciplinary team from Northwestern University recently completed a series of first human studies on premature babies at Prentice Women’s Hospital and Ann & Robert H. Lurie Children’s Hospital of Chicago. The researchers concluded that the wireless sensors provided data as precise and accurate as that from traditional monitoring systems, whilst being gentler on a newborn’s fragile skin and allowing more skinto-skin contact with the parent. This study has been published in the journal Science. The study includes initial data from more than 20 babies who wore the wireless sensors alongside traditional monitoring systems, to allow a side-by-side, quantitative comparison. Since then, the team has conducted successful tests with more than 70 babies in the NICU. “We wanted to eliminate the rat’s nest of wires and aggressive adhesives associated with existing hardware systems and replace them with something safer and more compatible with parent-child interaction,” said John A. Rogers, a bio-electronics pioneer, who led the technology development. “We were able to reproduce all of the functionality that current wire-based sensors provide with clinical-grade precision. Our wireless, battery-free, skin-like devices give up nothing in terms of range of measurement, accuracy and precision; they even provide advanced measurements that are clinically important but not commonly collected.” John A. Rogers co-led the research with Dr. Amy Paller, dermatology department chair, Walter J. Hamlin 22

NORTHWESTERN UNIVERSITY DISCUSSES THEIR RESEARCH ON WIRELESS SENSORS THAT THEY HAVE DEVELOPED FOR MONITORING BABIES IN NEONATAL INTENSIVE CARE UNITS. professor of dermatology and professor of paediatrics at Northwestern’s Feinberg School of Medicine, and Dr. Shuai (Steve) Xu, an instructor of dermatology at Feinberg School of Medicine and a Northwestern Medicine dermatologist. CUTTING THE CORDS Typically, five or six wires connect electrodes on each baby to monitor for breathing, blood pressure, blood oxygen, heartbeat etc. Although these wires ensure health and safety, they constrain the baby’s movements and pose a major barrier to physical bonding during a critical period of development. “We know that skin-to-skin contact is so important for newborns, especially those who are sick or premature,” said Paller, a paediatric dermatologist at Lurie Children’s Hospital. NEW MOTHER FRUSTRATED BY INABILITY TO HOLD HER NEWBORN After an emergency C-section, Taylor’s daughter Grace was rushed to the NICU, where she remained for three weeks. Taylor and her husband felt exhausted when navigating the wires to provide Grace with the most basic care. Grace is among the 70 babies who have participated in the side-byside comparison study so far. “Trying to feed her, change her, swaddle her, hold her and move around with her with the wires was difficult,” Taylor said. “If she didn’t have wires on her, we could go for a walk around the room together. It would have made the entire experience more enjoyable.” STRESSFUL AND DIFFICULT TO TAKE BABY OUT OF CRIB “The efforts that parents and nurses have to go through just to take the baby out of the crib are astounding,” said Dr. Aaron Hamvas, the Raymond and Hazel Speck Berry professor of neonatology at Feinberg School of Medicine, and division head of neonatology at Lurie Children’s Hospital. “Anybody who has had the experience of entering a NICU immediately notices how tiny the babies are, and how many wires and electrodes are attached to them,” said Dr. Debra Weese-Mayer, the Beatrice Cummings Mayer professor of paediatric autonomic medicine at Feinberg School of Medicine and chief of paediatric autonomic medicine at Lurie Children’s Hospital. “The opportunity to go wireless has enormous potential for decreasing the burden for the nurses, babies and parents.” GOING BEYOND CURRENT POSSIBILITIES The dual wireless sensors monitor babies’ vital signs such as heart rate, respiration rate and body temperature. One sensor lays across the baby’s chest or back, while the other sensor wraps around a foot. Each sensor weighs about the same as a raindrop.

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SENSORS

“Differences in temperature between the foot and the chest have great clinical importance in determining blood flow and cardiac function,” Rogers said. Physicians also can measure blood pressure by continuously tracking when the pulse leaves the heart and arrives at the foot. Currently, there is not a good way to collect a reliable blood pressure measurement. A blood pressure cuff can bruise or damage an infant’s fragile skin. The other option is to insert a catheter into an artery, which is tricky because of the slight diameter of a premature newborn’s blood vessels. It also introduces a risk of infection, clotting and even death. “We are missing a great deal of information where there may be variations in blood pressure over the course of the day,” Hamvas said. “These variations in blood pressure may have a significant impact on outcomes.” The device also could help fill in information gaps that exist during skin-to-skin contact. If physicians can continue to measure infants’ vital signs while being held by their parents, they might learn more about just how critical this contact might be. Transparent and compatible with imaging, the sensors also can be worn during X-rays, magnetic resonance imaging and computed tomography scans. “Wires are not just a physical impediment to interacting with the baby but also disrupt imaging if left in place,” Paller said. “You can do imaging with the sensors in place and continue monitoring the baby.” SAVING ‘INCREDIBLY FRAGILE’ SKIN The blood pressure cuff isn’t the only potentially damaging part of current technology. Sticky tape that adheres the wires to the body can cause skin irritation, blisters and, ultimately, infections. In some cases, this damage can lead to lifelong scarring. “Premature babies’ skin is not fully developed, so it’s incredibly fragile,” Paller said. “In fact, the thickness of the skin in premature infants is reduced by 40 percent. That means we have to be very careful.” The Northwestern team has studied 70 babies in the NICU thus far and found no sign of skin damage from the wireless

Weighing as much as a raindrop, the chest sensor can wirelessly monitor heart rate, breathing rate, and temperature. Credit: North Western University

sensors. The sensor’s skin-saving secret lies in its lightweight nature, thin geometry and soft mechanics. The paper-thin device is made from bio-compatible, soft elastic silicone that embeds a collection of tiny electronic components connected with spring-like wires that move and flex with the body. Rogers worked with long-time collaborator and stretchable electronics and theoretical mechanics expert Yonggang Huang to come up with an optimal design. Huang is a Walter P. Murphy professor of civil and environmental engineering and mechanical engineering and professor of materials science and engineering at Northwestern’s McCormick School. “If you look back to the 1960s, the basic approach to monitoring infants is essentially the same as it is today,” Rogers said. “It’s taped-on sensors, wires to external boxes of electronics. That’s all that’s ever been done. “The strength of the adhesive required to keep our lightweight device on the skin is much lower than that of the kinds of adhesives needed to maintain an interface between a hardwired sensor and an external box,” Rogers continued. “We have seen no adverse side effects in our study, not even a hint of skin injury even in the most frail babies.” The wireless sensor communicates through a transmitter placed underneath the crib’s mattress. Using radio frequencies, the same strength as those in radiofrequency identification tags, the antenna transmits data to display at the nurses’ station. Although it can be sterilized and reused, the sensor is cheap enough that it can simply be discarded after 24 hours and replaced with a new one to eliminate any risk of infection. WHEN WILL WIRELESS SENSORS APPEAR IN AMERICAN HOSPITALS? Rogers estimates that his wireless sensors will appear in American hospitals within the next two to three years. With support from two major non-profit organisations, Rogers’ team expects to send sensors to tens of thousands of families in developing countries over the next year as part of an international effort.

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TPEs FOR MEDICAL APPLICATIONS

21 - 23 May

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TUBING, CATHETERS & STENTS

MAKING NEW DISPOSABLE LUER LOCK CONNECTOR REDUCES PRODUCTION TIMES AND SAVES MONEY WITH IN-HOUSE PRODUCTION.

n order to keep up with customer demand and production needs, Qosina, a global supplier of single-use medical devices, recently selected Evonik’s Cyrolite G-20 Hiflo acrylic-based copolymer compound to manufacture their own specialized Luer lock connector. Cyrolite G-20 Hiflo is an advanced medical acrylic and is primarily used for the production of disposable medical devices. “Delays in manufacturing were creating issues for us in terms of meeting customer demand in a timely fashion,” said Geri Trautman, product development manager at Qosina. “So, after we started working on our own tooling and moulding source, Evonik pointed us toward their Cyrolite G-20 Hiflo, a material that is easy to process and saves us considerable production costs over the long run.” A BPA-free, impact-modified copolymer ideal for the injection moulding and extrusion of medical devices, Cyrolite G-20 Hiflo offers a balance of physical properties and chemical resistance as well as excellent processability and flow characteristics paramount for extremely thin-walled applications and complex multi-cavity moulds. Cyrolite can also be bonded to PVC tubing and sterilised by EtO gas and gamma irradiation. Cyrolite G-20 Hiflo ultimately lowered the cost of production due to reduced mould temperatures, ease of processability, and fast cycle times. “This efficiency in the production process, coupled with proven performance capabilities, made this a win-win across the board for us,” said Michael Gillis, supplier relations manager at Qosina. “We were able to make more parts in less time, enjoy less downtime on the moulding machine, and also take advantage of energy cost savings due to increased productivity.”

Qosina disposable Luer lock connector designed for a variety of catheter and drainage applications. Now made with Cyrolite G-20 Hiﬂo

“When customers come to us for material recommendation, collaboration is important to ensure that all stakeholders share the application requirements and material knowledge,” said Maurice Biagini, commercial director at Evonik. “In this case, Cyrolite G-20 Hiflo was the perfect choice for the application because it has the right balance of physical properties, chemical resistance and processability.”

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EXPO

#MedTechExpo @medtechonline

200+ EXHIBITORS 4,000+ ATTENDEES 3 CONFERENCE STAGES

MED-TECH INNOVATION

15-16 MAY

2019

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LIVE AT THE NEC, BIRMINGHAM

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ELASTOMERICS

MATERIAL MOVEMENT BRIAN REILLY, BUSINESS DEVELOPMENT DIRECTOR, BIOMATERIALS FOR NUSIL, HIGHLIGHTS THE OPTIONS FOR REDUCING FRICTION WHEN USING SILICONE ELASTOMERS.

ilicone has a long and proven history of use with medical devices and can provide many benefits, from flexibility to cushioning. However, silicones can present challenges due to an inherent surface tack. The surface of cured silicone elastomers is sometimes characterized by a high coefficient of friction (CoF), some degree of tackiness and a tendency for blocking (sticking to itself by virtue of chemical affinity). These characteristics may need to be addressed in applications that require a moulded or extruded silicone component to move or slide with minimal friction. As medical device designers account for friction, one solution is self-lubricating liquid silicone rubber (LSR), which eliminates an extra step to apply lubrication. Another solution is the use of a low CoF silicone coating applied to the surface and then cured to chemically bond the coating to the substrate for a non-tacky surface. SELF-LUBRICATING LSRS The traditional solution to these friction challenges requires medical device manufacturers to apply a silicone lubricant onto the moulded part as a separate manufacturing step, however, selflubricating LSRs are now available. The lubricity is built into the silicone elastomer system which yields a lubricious surface on the moulded component. The elastomer system is formulated with a proprietary additive that elutes out over time after vulcanisation. The performance of many medical devices depends upon minimising friction at the interfaces between various components, and self-lubricating LSRs provide the basis on which to produce effective results. Potential uses for self-lubricating silicone elastomers include balloons, valves, stoppers, O-rings, silicone devices with moving or sliding parts and parts that require assembly. LOW COF SILICONE COATINGS Other methods to overcome the high degree of surface tack and blocking with silicone elastomers include cured silicone coatings. When applied to the surface of the part and cured to chemically bond to the substrate, the coating mimics the mechanical properties of the underlying substrate. The outcome is a â&#x20AC;&#x153;dryâ&#x20AC;? lubricity that reduces the CoF on the surface of silicone parts and eliminates concerns about migration, leaking or rubbing off that are commonly associated with traditional lubricants. Coating options differ in how they are designed to cure e.g heat cure (HTV) or room temperature vulcanisation (RTV).

A low coefficient of friction coating (left) can reduce friction on the surface of silicone parts while eliminating concerns about migration, leaking or rubbing off that are commonly associated with traditional lubricants

With approximately the consistency of water, the coatings can be applied by dipping, but spraying is recommended. It achieves a smooth finish that results in more than a 50% decrease in the CoF when compared to a non-coated silicone. NuSil technology experts recently conducted a study to evaluate the static and kinetic CoF of coated vs. non-coated silicone surfaces. The force it takes to initiate movement between the silicone rubber and a steel panel (static CoF) was measured, as well as the force needed to keep the silicone rubber moving against a steel panel (kinetic CoF). Both a 70 shore A durometer liquid silicone rubber and 50 shore A durometer high-consistency rubber were tested according to ASTM D 1894 at ambient conditions. During the test, samples were placed on a stainless-steel panel with a mirror finish. On average, the coated samples demonstrated up to 74% reduction in static CoF, and up to 59% reduction in kinetic CoF depending on the silicone rubber substrate. Both lubrication options provide advantages for the healthcare industry. Low CoF coatings are ideal, not only for their performance relative to friction reduction and regulatory concerns, but also because they achieve critical performance goals with negligible impact on the mechanical properties of the silicone substrates they coat. Therefore, a silicone device that must bend, twist, elongate, etc., can handle this movement, coated or uncoated, without cracking, flaking or peeling. Self-lubricating silicone elastomers may be chosen to reduce the number of processing steps required; the elastomer can also be specified with the physical properties and level of lubrication needed for the application.

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MTI EXPO

THERE’S NO BUSINESS LIKE SHOW BUSINESS MED-TECH INNOVATION EXPO IS BACK FOR 2019, BIGGER AND MORE DIVERSE THAN EVER. THE MEDICAL TECHNOLOGY SECTOR IS CHANGING, AND WITH THOSE CHANGES COME NEW REQUIREMENTS ON ENGINEERING. THIS YEAR’S EXPO WILL DEMONSTRATE THE BEST-IN-CLASS SOLUTIONS TO ADDRESS THESE NEW CHALLENGES. A NEW HOME Reflecting the current surge in interest in medical technologies, the event has seen growth on all sides in recent years. That’s why, for 2019, the Expo is relocating from its previous venue in Coventry, to the NEC in Birmingham. This year promises to be more international than ever before, with trade delegations expected from around the world, taking advantage of the central transport links into Birmingham International. Duncan Wood, chief executive of Rapid News Group, the organiser of the event, had this to say: “Our ambition for the show in terms of size and both national and international impact can only be satisfied by the UK’s premier exhibition venue. When we acquired the show back in late 2016 we always had this move in mind. Now, with two successful growth years under our belt, it is the time to take this step.” KEY EXHIBITORS FOR THE PLASTIC COMMUNITY The West Group, on stand F1, will be a crucial stop for anyone with miniature fluid control requirements. The group is a specialist outsourcing partner in this field, and combines component supply with services like cleanroom production. Another key player for outsourcing is Boddingtons, on stand E3, which promises its ‘biggest and best yet’ stand at this year’s expo. CEO Andy Tibbs explained: “All of us at Boddingtons are relishing the opportunity to do a significant amount of business at Med-Tech Innovation Expo. “Together with several valued clients we will exhibit the best of our injection moulding expertise and services – though the products on display and by illustrating and explaining the processes and the technology that made them." Tibbs added “We will also bring the environment of our new £4.6m Marden facility into the NEC via the medium of video. In particular we will feature the capabilities of our Class 7 Cleanroom production – making a variety of Class 1 and Class 2 devices for international markets.” Meanwhile on the Medilink Pavillion, Midas Pattern Company will be showcasing a selection of high-quality polyurethane RIM mouldings, for medical device enclosures. The group says that from the initial discussion, it can turn around a project in a matter of days to support with time-to-market. CRUCIAL CONFERENCE SESSIONS Across three stages and over two days, a stellar line-up of international speakers will discuss challenges and opportunities for medical device manufacturers of all kinds. On the HealthTech Stage, Sarah Trenfield, director of innovation at FabRx will explain how 3D printing can revolutionise the healthcare sector by enabling the production of personalised medicines. The talk will also assess the latest research and technological developments in this emerging field, and evaluate the implications for the future. On day two, Leanne Taylor, head of content at Rapid Plastics Media will be joined by Dr Artemis Stamboulis, senior lecturer in biomaterials and nanomaterials at the University of Birmingham, and Helena Flowers, owner and managing director at Andel Plastics, for a panel discussion on the role of women in healthtech and engineering.

MTI EXPO

SIGN OF THE TIMES JEANETTE KUSEL, DIRECTOR FOR NICE SCIENTIFIC ADVICE DISCUSSES THE LAUNCH OF A NEW MODULE OF THE META TOOL AND THE CHANGING FACE OF THE DIGITAL HEALTH TECHNOLOGY LANDSCAPE IN THE UK.

ll around us a new generation of technologies are changing our lives, from the everyday use of satnavs and smartphones through to the profound understanding in the ability of genomics to help us develop personalised medicines for individual patients. The proliferation of digital health technologies, including mobile health apps and wearable sensors, holds great promise for improving the health of the population. As with other new health technologies, demonstrating evidence of their benefits and costs is a fundamental requirement of the health system and a potentially limiting first step to adoption into clinical practice. The UK has the chance to lead the world on healthtech. We already have some of the world’s foremost healthtech companies bringing new innovations and advancing the international reputation of our excellent science and research base. In the NHS, we have the world’s largest health institution and in the National Institute for Health and Care Excellence (NICE) we have one of the world’s most respected health technology assessment bodies. Working collaboratively, we have the opportunity to build an ecosystem that continually creates, develops and adopts the best healthtech. NICE EVIDENCE STANDARDS FRAMEWORK TO SUPPORT DIGITAL HEALTH TECHNOLOGY UPTAKE As digital health innovations have developed at an increasing pace, it has been a challenge to identify which are clinically effective and offer economic value for patients and the healthcare system. To help address this issue, NICE has recently published a new evidence standards framework for digital health technologies. The project was led by NHS England and the NICE framework was developed in partnership with other healthcare organisations, including MedCity and DigitalHealth London, with input from commissioners, industry and academia. These evidence standards are leading the way in providing both developers and commissioners with an understanding of what good levels of evidence look like for digital health technologies according to the type of technology and the level of risk to patients and to the health budget impact. The standards cover both the clinical and economic impact of the new technology and outline what evidence is needed to develop a case for their adoption and use by the health and care system.

Jeanette Kusel, director for NICE scientiﬁc advice

THE NICE SCIENTIFIC ADVICE META TOOL In 2017, NICE’s scientific advice service launched an online tool to help developers of medical devices, diagnostics and digital health technologies understand and generate the evidence needed to show their products are clinically and cost effective. The Medtech Early Technical Assessment (META) tool has been developed in partnership with Greater Manchester Academic Health Science Network. The tool aims to help companies identify what evidence they have and what gaps need to be filled to satisfy payer requirements. This should help companies prepare for a dialogue with health technology assessment organisations and payers to potentially speed up time to market. It is an affordable service aimed at, but not limited to, small and medium sized companies. The META tool can be licensed for use by facilitating organisations working with medtech companies. This broad accessibility will allow NICE to maximise the META tool’s potential, to support the medtech industry, and make it available to companies not just in the UK but also internationally. NICE will be talking about the new launch on the introducing stage at 1pm during the Med-Tech Innovation Expo.

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MTI EXPO

PROMINENT PACKAGING THE ORGANISERS ACKNOWLEDGE THE IMPORTANCE PACKAGING HAS TO PLAY IN THE MEDTECH SECTOR AT THIS YEAR’S MED-TECH INNOVATION EXPO.

ackaging is a key part of the medtech supply chain. For 2019, the UK’s only dedicated conference and expo will include more content for the packaging sector than ever before. DEVELOPING SIMULATION TO TACKLE REAL-TIME PACKAGING ISSUES Sean Egan, director of global marketing at Nelipak Healthcare Packaging This presentation will cover the development of simulation for thermoformed custom packaging, design, product integrity testing, predicted behaviour and performance, and first prototype samples. The session will also examine how simulation can provide data on material thickness during forming and how it can impact drop testing and reduce material gauge towards more sustainable solutions. In a recent article for Med-Tech Innovation, Egan explained: “Involving a packaging partner at the earliest stages of product development can allow for the creation of innovative packaging that is both fit-for-purpose and as sustainable as possible.” STENT PACKAGE INTEGRITY: REGULATORY SHIFTS AND THE TECHNOLOGICAL DRIVERS Donal Harrington, director of life sciences at Anglo Production Process (APP) The discussion will encompass package integrity testing, USP 1207, and regulatory shifts to come. Taking the right approach to establish package quality testing protocols and implementing the proper test method is necessary to reduce patient or consumer risk by delivering high-quality, defect-free packaging. USING SIMULATION TO VALIDATE PERFORMANCE OF DRUG DELIVERY SYSTEMS Christopher Smith, principal engineer at Wilde Analysis This session will present a holistic approach to simulation of an injection-moulded drug-delivery system. The presentation will demonstrate the importance of considering manufacturing processes when validating in-service performance and how simulation tools can be used to inform the design process. On the show floor, professionals from all areas of the medical device supply chain will demonstrate their newest and most exciting solutions for ambitious technology users. Highlighted below are just some of the packaging exhibitors this year: Nelipak, a global leader in Healthcare Thermoformed Packaging with world class reputation for quality and service will be on stand F3. Nelipak provides custom-designed plastic packaging to the medical device and pharmaceutical markets, which protects their products to the point of use. Oliver Healthcare Packaging is a leading supplier of pouches, lidding, roll stock, and mounting cards for the global healthcare industry and will be on stand D7. Their packaging protects medical

devices and pharmaceutical products throughout the sterilization, shipment and storage processes. New for 2019: Oliver Healthcare Packaging announced the acquisition of CleanCut Technologies, a medical packager based in USA. Mike Benevento, Oliver’s CEO, said: “This partnership allows us to maintain our exclusive focus in healthcare while increasing our reach in an industry we know and love.” Bemis Healthcare Packaging will be on stand G29. They provide highquality, engineered packaging solutions tailored for the protection of cuttingedge medical devices, sensitive drugs and sophisticated diagnostic systems. Specialising in the manufacture of coextruded, laminated and flexible films, foil barrier laminations, pouches, bags, thermoformed trays, lids, labels heat seal coated DuPont Tyvek and medical grades of paper. MPH will be on stand F10 and are suppliers and manufacturers of printed flexible packaging and labels, including sachets, pouches, flow wrap, top and base web constructions for the Pharmaceutical, Medical and Healthcare sectors. Innovators in ‘Reductive Laminates’ and Anti-Bacterial Coating Technologies. Riverside are specialists in complex medical device manufacture, medical packaging solutions and contract fulfilment and will be exhibiting on stand F3. Riverside Medical Packaging are a leading supplier of packaging machines and complete packaging line solutions. With over 40 years’ experience across the UK and Ireland, IPP (formerly APP) is a technical distributor of manufacturing equipment to the pharmaceutical and medical device sectors, specialising in packaging equipment, packaging inspection and testing equipment, automation and manufacturing equipment, and serialisation equipment. They can be found on stand D3.

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EXTRUSION

SUPPLY versus DEMAND COMPOUNDING SOLUTIONS, A SPECIALIST IN MEDICAL EXTRUSIONS, HIGHLIGHTS TECHNOLOGIES SUCH AS REZILOK WHICH IT BELIEVES ADDRESS SOME OF THE CURRENT NEEDS OF THE MEDTECH SECTOR.

n the medical device industry, the trend towards minimally invasive surgical techniques is the driving force for smaller, more innovative medical devices. Devices for vascular and other applications continue to reach deeper into the anatomy with more therapeutic technology, whilst medical device manufacturers are demanding polymeric tubing that boasts greater precision, tighter tolerances and increased functionality. In catheter design, the designer must not only consider the functional requirements of the application but also be cognizant of the manufacturing process required to produce the device. The designer must identify the key performance requirements of the medical tubing properties such as flexibility, lubricity, clarity, kink resistance, push strength, torque transfer characteristics, hoop strength, radiopacity and bondability.

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 Solutionsâ&#x20AC;&#x2122; Mobilize technology, a lubricious additive that can be incorporated with the inner layer material to reduce the coefficient of friction. The material in the outer layer of the shaft is generally a coloured nylon 11, nylon 12 or poly-ether block amide (PEBA) compound. Often various durometers are required along the length of the shaft to ensure the correct combination of pushability at the proximal end and flexibility at the distal tip end. The designer should consult with the compound supplier as very often these compounds will need to be stabilised so that the material is not degraded during the assembly process. This process often involves heat, exposure to ultraviolet light and high stresses. Special compounding techniques need to be employed to ensure optimal dispersion of the pigments and stabilisers as the tubing wall can often be as low as 0.002â&#x20AC;?.

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EXTRUSION

If a HDPE is used on the inner layer and a nylon or PEBA on the outer layer as described above, 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. The polymer marker band is advantageous in that it does not impede the flexibility of the distal end, which a rigid metal marker band may do. 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, even as high as 90% in some applications. 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. Typically, on the injection moulded hub at the proximal end of the device, devices are labelled with critical product information. Due to recent FDA regulations going into effect, specifically the unique device identification (UDI) system, Original equipment manufacturers are now exploring laser marking options in medical compounds. Not all thermoplastics are easily laser markable, therefore additives have to be used to highlight the contrast and make laser marks more visible. MasterMark technology is a laser marking additive developed by Compounding Solutions to offer a high quality, versatile and efficient solution for direct marking with the most commonly used types of laser sources. Laser marking is the preferred method for product identification in the healthcare industry. It provides a solvent-free, permanent, and cost-effective solution for the identification of plastic medical device components. The current transition of the healthcare market demand produces devices designed to diagnose and treat patients with innovative layout. The medical device manufacturing industry requires new compounds to meet reforms, technology, and law requirements. The medical device manufacturing companies need new compounds and material technologies to support the urgency of changes in the MedTech industry.

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In catheter design, the designer must not only consider the functional requirements of the application but also be cognizant of the manufacturing process required to produce the device.

International exhibition and conference on the next generation of manufacturing technologies Frankfurt, Germany, 19 – 22 November 2019 formnext.com

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EXTRUSION

act VISTAMED, PART OF FREUDENBERG MEDICAL, HIGHLIGHTS THE IMPORTANCE OF EXTRUSION IN CATHETER DEVELOPMENT.

he extrusion and catheter finishing processes are inextricably linked and balancing these processes can be a complex undertaking.

There are a number of variables that can ultimately affect the performance of a finished catheter, the most paramount are the properties of the raw material and the extrusion process. Careful consideration of the extrusion process is essential to ensure consistency and repeatability. Including extrusion engineers in the development decision making process is integral, and collaborative communication between customer and supplier will also enhance concept development and ultimately get devices to market faster. It is important to keep in mind that there is far more to tubing than dimensions. Establishing a “see it, say it, fix it together” culture is key to getting a tube from concept to production. CONTROL INPUTS AND OUTPUTS The manufacture of high-quality extrusions used in sophisticated catheter systems is greatly affected by tight control of the “inputs”. Initially, the inputs start with people, because people can influence the other inputs like training, material handling, storage conditions, control of drying and equipment, tooling design, etc. Therefore, having the right mix of people is a good starting point. The greater the control of inputs to the extrusion process, the higher the probability of achieving the desired output necessary to develop and manufacture high quality extrusions. “Outputs” begin with process stability, and then the spotlight turns to achieving the agreed upon customer specifications, such as critical dimensions, visual criteria, and functional performance. The tolerance expectations from customers are constantly challenging the boundaries of extrusion capability. It has become more significant than ever for tubing manufacturers to maintain close control of their inputs and process.

POLYMER SCIENCE AND MATERIAL BEHAVIOUR A good understanding of polymer science and material behaviour is undeniably crucial for producing highquality catheters and balloons. The morphological structure of the thermoplastic material can change with varying thermal conditions which, in turn, determines key physical properties such as strength and flexibility. The polymer exits the die head of an extruder in an amorphous state and the rate and length of the cooling downstream from an extruder controls the degree of crystallinity in the final product. In some medical applications, such as balloon forming, it is critical that the extruded tubing is amorphous prior to the balloon forming process. Therefore, the cooling parameters and cooling method used are critical to ensure that crystallisation does not occur in the tube during the extrusion process. In other applications, such as the extrusion of polyether ether ketone (PEEK) tubing, it is critical that the PEEK tubing achieves a relatively high level of crystallinity during extrusion to ensure that the tubing utilizes the outstanding properties that PEEK possesses. To produce high quality balloons and catheter systems, it is fundamental to have all the extrusion inputs under control. A capable process with high quality melt is critical to produce tubing for consistent balloon quality and desired performance. Additionally, a sophisticated extrusion process with precise in-line monitoring and control is also crucial to achieve high quality balloon tubing. Small process variations can undoubtedly hinder the quality and performance of the final product. These variations potentially impact melt homogeneity and can result in variability in balloon tubing performance.

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Medtech needs them: visionary innovations. T4M – Medical Technology Expo 7 – 9 May 2019 · Messe Stuttgart

Production technologies, processes and materials for the medical engineering sector: take advantage of the combination of shows, forums, workshops and networking to meet the right people and engage with ground-breaking ideas.

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Technology for Medical Devices t4m-expo.com/2019 · #T4M2019

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3D PRINTING

THE PRINT QUEEN’S UNIVERSITY BELFAST HAS INVESTED IN A 3D BIOPRINTER FROM GESIM FOR RESEARCH INTO THE MANUFACTURE OF MEDICAL DEVICES AND DRUG DELIVERY SYSTEMS.

nalytik, a company that provides cutting-edge scientific instrumentation, have announced the recent installation of GeSiM 3D bioprinter at Queen’s University Belfast. It will be used in the development of new processes including the manufacture of medical and drug delivery devices. The company claim, ‘L3D printing could revolutionise personalised medicine’ by creating complex devices tailored to the individual patient through precise control of device geometry, materials and internal architecture. Instrumentation such as the family of modern 3D printers from GeSiM are being used to advance the development of new biodevices. The GeSiM BioScaffolder 3.2 is a flexible 3D bioprinter with a unique piezoelectric micro-pipetting system for pico- and nano-litre spotting of cells and biomolecules, as well as pneumatically-actuated cartridges for precise printing of highly viscous materials (e.g. molten thermoplastic polymers) on definable coordinates within a scaffold structure or on flat surfaces. This combination of both technologies is unique and not available on competitor 3D printers. The BioScaffolder can print polymers at temperatures up to 250 °C, while cells and biomolecules (e.g. enzymes, proteins) can be maintained at 37 °C or chilled to enhance stability. This innovative approach allows struts of mechanically-stiff materials to be combined with cell-friendly materials (e.g. hydrogels) containing suspended cells in novel regenerative medicine approaches. The instrument automatically aligns print tools of different dimensions by means of a 3-axis light barrier. Struts of up to three different materials can be combined, even in a single layer. Individual cells, cell suspensions and aqueous polymer solutions can be printed onto substrates for applications in single-cell analyses, biosensing and drug delivery. Importantly, the BioScaffolder can be interfaced with existing analytical equipment, with individual cells or minute-volume solutions accurately printed directly into multi-well plates, or onto microfluidic chips or biosensor substrates. GeSiM have recently added melt electrospinning for fibre production and UV-curing capabilities, while a new core-shell tool allows precise printing of tubes, with either a hollow bore or soft internal material, further extending utility.

PROFESSOR RYAN DONNELLY WITH THE GESIM BIOSCAFFOLDER 3D BIOPRINTER WHICH HAS RECENTLY BEEN INSTALLED IN THE SCHOOL OF PHARMACY AT QUEEN’S UNIVERSITY BELFAST.

healthcare products, devices and technologies and promote clinical translation of research advances from bench to clinic.” Product Specialist, Hiran Vegad, says, “Working with Professor Donnelly and his group at Queen’s is already proving extremely exciting. Their broad focus will impact on the prevention of disease, antimicrobial resistance, improved diagnoses, better treatments and enhancing understanding of cancer and inflammatory diseases to the benefit of patients worldwide. As suppliers, we at Analytik look forward to playing an active role in this program over the coming years.”

Professor Ryan Donnelly holds the Chair in Pharmaceutical Technology in the School of Pharmacy at Queen’s University Belfast. His research is focused on the design and physicochemical characterisation of advanced polymeric drug delivery systems for transdermal and topical applications. He describes the plans for his recently installed bioprinter which was funded by a Wellcome Trust Multi-use Equipment grant. “Our overall aim is to, for the first time, extend the utility of 3D bioprinting from applications in regenerative medicine into reproducible manufacture of micron-scale drug delivery devices, biosensor production, single cell analyses and enhanced understanding of tumour microenvironments. These novel uses of 3D bioprinting have the potential to make a significant and far-reaching impact, in improving health and therapeutic outcomes for patients. “This is the first 3D bioprinter in our university and, to our knowledge, is the first instrument with the unique capabilities of the BioScaffolder in Ireland. Together with my colleagues, we plan to follow the Wellcome Trust’s strategy on improving health for all, in that it will accelerate the application of research to improve health and drive forward development of new

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10/10/2018 12:51:58

TESTING & INSPECTION

MEDICAL PLASTICS NEWS WEB CONTENT EDITOR IAN BOLLAND RECENTLY SPOKE TO DR COLIN GRANT, AN SPM SALES & APPLICATIONS SPECIALIST AT HITACHI’S SCANNING ELECTRON MICROSCOPE LAB, TO FIND OUT HOW THE FIRM’S LATEST TECHNOLOGY CAN BENEFIT MEDICAL DEVICE MANUFACTURERS.

‘A

lmost idiot proof’ was how Dr Colin Grant described the ease of operation of the Hitachi AFM 5500M microscope when Medical Plastics News was invited to the Daresbury lab to see the role that the new product can have in the medical device industry. Given the right, and relatively straightforward training, he is a believer that Hitachi’s microscopic technology for analysing can be operated from someone who may regard themselves as a novice previously. “Where the Hitachi brand stands out is that it is fully automated,” Dr Grant explained, “It literally is click, load, image.” Automation appears to be the USP of Hitachi’s microscope as it has been designed for ease of use when it comes to analysing the surface of any type of material. “I know in Japan these types of things are really good for semi-conductor industries where surfaces really are absolutely critical. It’s used quite predominantly in pharmaceuticals, quite a lot in automotive, imaging, aerospace. Anywhere where you’ve got a surface that is actually quite critical”, Dr Grant added.

UNDER THE

MICROSCOPE

Surfacing, of course, isn’t out of place in the world of manufacturing medical devices, as well as medical grade plastics. Quality control is a big part of what these microscopes can do, while there is also the advantage of not needing to be an advanced user. The microscopes can allow for analysis of the characterisation of its material properties, for example, its strength, elasticity, its WWW.MEDICALPLASTICSNEWS.COM

TESTING & INSPECTION

stiffness. It can allow a surface to be scanned, poked and measured for electrical currents – with Dr Grant saying this an area of interest for researchers in life sciences. This includes comparing materials, being able to examine materials if they have failed in any way, process evaluation, as well as the ability to identify any kind contamination or if corrosion features on the materials. “Yes, you can be an advanced user but if you need to know a surface, what it looks like, its roughness value, I think anyone could learn how to use one of these fairly quickly. You don’t need a physics degree, you don’t need a PhD, any technician would be able to grasp this pretty quickly. “If manufacturers need to understand the characteristics of their surfaces (topography, roughness, mechanical properties etc.) or require a degree of quality control – at high resolution (i.e. between the micro and nano-scale) – then the atomic force microscopy (AFM) technique might provide them solutions. “Our system has key benefits as it is fully automated, so anyone from lab technicians to advanced research professors can use it.” Not all materials are the same and not all manufacturers want their materials to be at the same temperature, as specifications vary from manufacturer to manufacturer, but the Hitachi microscope allows for analysis for individual manufacturers to tailor their needs. Dr Grant added: “There are other techniques around but, in essence, this is probably one of the most high-precision, highly accurate quantitative metrology measurement instruments available really.” The Hitachi microscopes show a way to measure very small film thickness, and the various domain sizes. One analysis seen by Medical Plastics News also showed the ISO standard roughness measurements that accompanied the analysis of polymer blend surfaces.

“Preferably it sticks elsewhere, it’s not completely foolproof – some bacteria would not be able to stick down to these surfaces. There are various different plastics where I think microscopy does come in where you’ve got some structure to your surface.” There is also room for exploring how polymers will react under different temperatures and whether the material is suitable for the manufacturer to use. “In terms of research and development, different polymers have different melting temperatures, so if you use a different melting temperature what does the end product look like? “It becomes more unique when you consider that this type of microscope can operate at a range of temperatures, in vacuum, in air, humidity, aqueous conditions. It can be adapted to the conditions of use for the product – or to test the limits or boundaries of the chosen materials in these environmental conditions.”

The microscope itself could work on its own for a long period of time, with the automatic features allowing work to take place out of hours and be ready for analysis when returning to the working day. As for the surface of any material, the analysis that can be provided by the AFM5500 can illustrate the roughness or smoothness of a surface in a 3D format. For the sporting aficionados, it’s not dissimilar to watching golf on the television and being forgiven for thinking that the course is a little flatter than usual – but if you were to watch it at the course itself, the slopes, hills and obstacles are then on show to appreciate how difficult it is to play 18 holes in 70 or fewer shots. With his background in academic research, Dr Grant explained that a field of research he and his academic colleagues are interested involves making small grooves within plastic to allow for the material to prevent bacteria getting inside or below the surface, if the application was protective packaging, for example. He explained that one of the research projects included making polymer surfaces like a saw tooth, with grooves in order to prevent any bacterial infiltration or contamination as much as possible. Though not foolproof, it’s an intriguing development in the academic world. “The distances here are in the order of about one to two microns so really, really small. The idea here is that they’re antimicrobial; because if you narrow the size of this, the bacteria would not be able to get in and it wouldn’t want to stay on top, it couldn’t get in between.

There are other techniques around but, in essence, this is probably one of the most high-precision, highly accurate quantitative metrology measurement instruments available.

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2019 NORTH AMERICA EVENT CALENDAR

JAN 29-31, 2019 // SANTA CLARA, CA

AUG 27-29, 2019 // SANTA CLARA, CA

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SEP 10-12, 2019 // NOVI, MI

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BIOMEDevice Boston, Design & Manufacturing New England, ESC

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SANTA CLARA CONVENTION CENTER

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JUN 4-6, 2019 // TORONTO, ON TORONTO CONGRESS CENTRE

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JUN 11-13, 2019 // NEW YORK, NY

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DEC 4-5, 2019 // SAN JOSE, CA SAN JOSE CONVENTION CENTER

BIOMEDevice San Jose

INDUSTRY 4.0

Road to recovery LUCY PAMMENT, A SUPPLY CHAIN TECHNOLOGY SPECIALIST FOR ACCESS GROUP, BELIEVES THE RECENT IMPLANT FILES SCANDAL WILL PUT FURTHER PRESSURE ON MEDICAL DEVICE MANUFACTURERS TO BUILD TRANSPARENCY INTO THEIR PROCESSES.

s the medical devices industry reels from the Implant Files controversy, manufacturers and distributors will no doubt be examining how their systems can demonstrate traceability, ensure positive patient outcomes, and safeguard their profits and reputations. It is only natural and right that major customers (like the NHS), healthcare professionals and patients are going to ask questions about the safety and effectiveness of medical devices – so what processes do you have in place to ensure compliance with legal and quality standards, such as ISO 13485 and GS1? A scandal like the Implant Files shines a light on the importance of an electronic audit trail, allowing manufacturers to trace raw materials, components and products back to the source, and containing relevant documentation such as test results. Many production managers already recognise the power of digital technology and are harnessing it to some extent. While digitalisation is not yet universal, I expect to see the pace of change accelerate as growing numbers of manufacturers adopt electronic data interchange (EDI) solutions to tackle challenges around traceability. As reported in Medical Plastics News, we have reached the point where terms like ‘connected health’, ‘digital health’ and ‘disruptive technologies’ are fast becoming the norm. No longer just for the trailblazers, Tier One manufacturers and small-scale suppliers alike are already benefitting from access to real-time data, actionable insights and connected supply chains across factories and warehouses. The question every supplier needs to ask is whether it wants to be the only one in a complex supply chain that has to search through multiple spreadsheets if a part or product is found to be defective? Or the one that continues to fax and post documents because there is no EDI software in place, running the risk of them being mislaid, inadvertently or even maliciously? Making the case for digitalisation even stronger is the fact that it is now key to winning new and repeat contracts. By 2019/20, suppliers to NHS acute trusts must be GS1 compliant – a standard that has resulted in cost savings of more than £4,000,000 at Guy’s & St Thomas’ NHS Foundation Trust (GSTT). Using GS1 barcodes and Global Trade Item Numbers (GTINs), hospital teams can track and trace any product, scanning it to access key data such as the batch number.

2077_AS_W19

The move towards barcode scanning and data sharing is not limited to the NHS, of course. As the Unique Device Identification (UDI) regulation come into force in both the US and EU, suppliers will be required to display an identifier – typically a barcode – that ensures full visibility for every device. As a result, defective or recalled products are removed easily before they adversely impact patients. Ultimately, it must be possible to ‘uniquely identify, track and trace individual medical devices through the supply chain and, importantly, into a patient pathway’– something that can only be achieved through effective data sharing and by holding quality and compliance documents in a secure, central location.

Lucy Pamment, supply chain technology specialist for Access Group

In the wake of the Implant Files, manufacturers and distributers will have to work hard to restore confidence among professionals and the public. With the need for transparency becoming more urgent, it is only a matter of time before data exchange via the cloud is mandatory in all areas of healthcare procurement. Developing IT infrastructure still seems like an insurmountable barrier – particularly for small and medium sized enterprises (SMEs), which account for 98 per cent of the 3,700 UK’s medical technology companies. Even so, a good software solution can be implemented with little or no downtime, is easy for staff to operate and can be scaled up according to production needs. At the very least, I would urge all manufacturers and distributors to have a digital strategy in place, which includes full data back-up and recovery services. Far from making their work more onerous, compliance with internationally-recognised standards opens up new doors for suppliers with major healthcare providers like the NHS. To make the most of these opportunities, however, manufacturers will need to ensure their processes meet agreed protocols as soon as possible.

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RECYCLING MEDICAL DEVICES

PLASTICS:

MORE THAN STRAWS & COTTON BUDS OLE GRØNDAHL HANSEN, PROJECT MANAGER OF PVCMED ALLIANCE, DISCUSSES HOW PLASTICS HAVE PAVED THE WAY FOR SIGNIFICANTLY LONGER LIVES DUE TO TREATMENTS THAT NO ONE COULD HAVE IMAGINED BEFORE POLYMERS GOT THEIR BREAKTHROUGH, AND WHY RECYCLING IS KEY FOR MEDICAL PLASTICS IN THE FUTURE.

n the heated debate on plastic pollution, we often see that people are encouraged to avoid plastic products. Why don’t we just use the materials we did before plastics were introduced? Plastic products are nothing more than imitations of products that we already had. Claims that are in principle correct. We had excellent windows before plastic windows were invented, excellent pipes before plastic pipes were introduced, and wax cylinders before vinyl records. So why not just go back and use the materials we did in the past?

The plastic blood bag was developed during the Korean War, as there was a need for a product to store blood that was not shattered when ejected from aircraft. Glass containers used in the past were obviously not suitable. The same is true for the health sector in general. Without a doubt, it was no less than a revolution when disposable plastic articles were introduced. Before plastics, hospitals relied on reusable articles made of traditional materials such as glass or rubber. Glass was fragile and rubber expensive, which meant the equipment had to be used repeatedly. It caused major problems with the hygiene, as many patients were infected due to repeated use. Affordable plastics made it possible to dispose of the medical equipment after it had been used only once. As a result, cross contamination between patients dropped significantly.

BETTER BILLIARD BALLS Let’s start with a curious but still excellent example that illustrates it is not as simple as you think.

But not only was the risk of infection greatly minimized, the quality of the products was also raised considerably after plastics entered the hospitals.

When plastics were invented, it was the result of competition. Ivory was in short supply for billiard balls.

For example, there is nothing that surpasses a Polyvinyl Chloride (PVC) tube when it comes to softness. Non-PVC medical tubing tends to “kink” so that the flow is stopped when the liquid is transported through the tubing.

New balls developed in plastic won the prize. And the plastic balls were not just a simple imitation of the ivory balls. The new balls were much more precise and cheaper to produce.

IMPOSSIBLE WITHOUT PLASTIC If you are in doubt about the importance of plastics in the healthcare sector, you should treat yourself to Medica, the world’s largest medical fair, held each year in Düsseldorf, Germany.

The example is very telling for the development of plastics. The new products being developed are often better than those they replace, and just as importantly, the products are made available to others than the elite.

THE BLOOD BAG The blood bag – obviously a more vital product than the billiard ball – is a similar story.

If you visit the various stands, you quickly become aware that the modern health service would be impossible to maintain without plastics. Polymers are everywhere, from advanced scanners to the previously mentioned disposable items. In fact, no stands exhibit equipment where plastics do not play a role in some form. But should we just sit back and rejoice at how innovative the plastic industry has been in patient care? No, of course not.

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RECYCLING MEDICAL DEVICES

We must try to recycle the plastic equipment than can be recycled. And fortunately, there are serious breakthroughs in recycling of medical equipment made of PVC, which is the most widely used plastic material in the healthcare sector. With inspiration from Australia, where about 200 hospitals are part of a scheme to recycle medical equipment, we are now also starting to look at this possibility in Europe. In the United Kingdom, about 20 hospitals are associated with a scheme for collection and recycling of oxygen masks and other medical devices. Other pilot projects are in the works in Germany and other parts of Europe. We need to explore the possibilities for how the PVC industry can support these recycling efforts with know-how and funding, and we are of course interested to hear from hospitals out there that want to participate in the circular economy.

Avoiding plastics is not the way forward. Plastics have paved the way for signiďŹ cantly longer lives due to treatments that no one could have imagined before polymers got their breakthrough.

NOT THE WAY FORWARD Avoiding plastics is not the way forward. Plastics have paved the way for significantly longer lives due to treatments that no one could have imagined before polymers got their breakthrough. For example, blood can last for up to 49 days in a PVC blood bag, which is essential for the supply of blood. In addition, there are the many major medical achievements based on plastic equipment, which is a prerequisite for modern research and development. But healthcare is of course not the only sector that is highly dependent on plastics. Space exploration, green energy, sustainable transportation and climate solutions would be unthinkable without polymers.

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EVENTS

Medtec China 2019 MEDTEC CHINA CLAIM THAT NEARLY 25,000 PROFESSIONALS WILL BE IN ATTENDANCE FOR THEIR THREE-DAY EXHIBITION IN SEPTEMBER THIS YEAR. The medical devices market in China is expected to exceed 600 billion yuan in 2019, with an estimated compound annual growth rate of 16.8%; thus, still preserving a relatively fast growth momentum. Stimulated by further population aging and consumption upgrading, the medical device industry is encountering new development opportunities. To drive forward the development of the medical industry and meet the market demand, Medtec China will initiate a three-day exhibition from September 25th to 27th, 2019 in Hall 2 of the Shanghai World EXPO Exhibition and Convention Centre for the first time. The exhibition is expected to accommodate over 400 suppliers from around the world, with a range of products and services covering design, research and development, raw materials, high precision parts, process technology and manufacturing equipment. It is estimated that nearly 25,000 professionals will gather together to participate in this industry event. This year, Medtec China will be expanding their regulation zone which was first introduced in 2018. In addition to the FDA, WuXi AppTec Group, and Kenolletc, the zone will also include well-known enterprises from Europe and America who provide medical regulation services to participate. Other zones include the life science and laboratory technology zone, the IVD zone for rapid development of the in-vitro diagnosis industry, and the mould technology and processing equipment zone which will host EGMedacys Devices, Omni Tech, Tessy Plastics, and SJ Group (HK).

Other companies attending Medtec China are Mikron, Leedon, Eastman, Lubrizol, Branson, Unitak, DuPont, AUSTAR, OGP, China Vision, TA, Trelleborg, and Freudenberg, with the recruitment of more exhibitors currently in progress.

MedtecLive 2019 MEDTEC LIVE EXHIBITION ANTICIPATES AROUND 400 EXHIBITORS FOR THE EVENT IN MAY THIS YEAR. The medical technology value chain will be represented at the Nuremberg Exhibition Centre for the international MedtecLive exhibition and the MedTech Summit Congress between the 21st and 23rd May this year. This event is expected to attract around 400 exhibitors, with two exhibition halls and a lecture programme. “From a standing start, MedtecLive will launch as an international networking platform based in southern Germany, and also as Europe’s second-largest exhibition for medical technology,” comments Alexander Stein, director MedtecLive at NürnbergMesse. Half of the exhibition area at the event in May will be taken up by companies in the fields of processing, manufacturing and mechanical engineering, whilst the other half will be split evenly between all other fields. “The entire sector hopes to contribute to the success of MedtecLive and definitely wants to be a part of the innovation platform when it launches in spring,” says Stein. The free industry forums in the exhibition halls offer knowledge and practical tips. Many partner entities will also be there with their expertise and will cover topics of current interest, from cyber security to the latest developments on all aspects of the European Medical Device Regulation (MDR), from hygienic design to artificial intelligence, recruiting skilled employees, and access to the international market. Young enterprises will introduce their developments at the Innovation Market Place, which is jointly supported by Medical Valley EMN and EIT Health, and VCLS Neighbourhood from France. During the start-up contest founders will offer an insight into their developments and business models in pitch sessions. The winners of the contest will be awarded top quality prizes at MedtecLive, provided by NürnbergMesse and its partners.

On the second day of the exhibition, the industry’s next generation will gather at the annual meeting of Young Professionals at Medtech, organized by the Association of German Engineers (VDI) as part of MedtecLive. This day will also include an intensive programme of lectures and workshops focusing on extremely popular forward-looking topics such as bioelectronics and artificial intelligence, which will appear on the agenda alongside regulatory issues relating to the MDR and requirements of clinical studies, and how to develop a career in medical technology. VDI is also actively involved in the latest industry topics in the exhibition forums. A “novelty stand” will give all visitors a rapid overview of the innovations being shown by the exhibitors, and an attractive VIP

EVENTS

“T4M (Technology for Medical Devices) Start-up World” encourages the exchange between company founders, established Small and Medium Enterprises (SMEs) and investors.

The entire sector hopes to contribute to the success of MedtecLive and deﬁnitely wants to be a part of the innovation platform when it launches in spring. lounge will provide an exclusive setting for discussions in private. The MedTech Summit provides the link between development and manufacture on the one hand and diagnostics and treatment on the other. For two days, this internationally renowned congress will bring together developers and users, with 70 lectures, workshops and interactive elements. The partnering event is an opportunity for congress and exhibition visitors to make appointments in advance and to engage in targeted, one-to-one discussions with potential business partners. These are just some of the ways in which MedtecLive and the MedTech Summit live aim to offer the perfect location for new business contacts and partnerships, and for solution-oriented dialogue. The package of events will be further expanded by CARAT, the indepth international conference on applied x-ray technology, which is to be held on the 21st May.

“T4M Start-up World” is joining forces with the trade journal Medtech Zwo to provide a professional platform for company founders to present their promising medical technology solutions, as well as providing the opportunity to engage with other industry representatives and investors. The event is also aiming to provide new opportunities for a cooperation between established SMEs and start-ups. Sixty start-ups from the medical technology sector will have the chance to introduce themselves at T4M, the new medical technology trade fair in Stuttgart. The “T4M Start-up World” exhibition will also include a pitching stage, on which start-ups from the medical technology sector can present their ideas to an expert jury of investors, medical technology industry representatives and business experts. There will also be a “Networking & Partnering” common area where visitors can lay the foundations for a new cooperation and partnership.

as well as access to possible cooperation partners within the sector. Established companies can also expect to find concise information about the various new medical technology trends, external financing options and opportunities for cooperation. “The Start-up World is an important element in our efforts to establish T4M as an attractive event for the medical technology sector, while at the same time showcasing its major innovative strengths,” explained Tanja Wendling, project manager for T4M. The new platform will be actively supported by local partners such as Clusterinitiativen BioRegio STERN Management GmbH and BIOPRO Baden-Württemberg GmbH, as well as start-up initiatives such as Life Science Accelerator Baden-Württemberg, the Foundation for Medical Innovation (Stiftung für Medizininnovationen) and the MedTech Startup School in Tübingen. Applications for participation in the “T4M Start-up World” and the pitching stage will be accepted from mid-November.

Taking place over three days, the “T4M Start-up World” will cover the most important industry segments for medical technology. It will aim to address key aspects such as prevention, inpatient care, outpatient care, rehabilitation, care and production/manufacture. “T4M Start-up World is the perfect event for anyone fascinated by the medicine of the future,” explains Sandra Wirsching, director of business development at BIOCOM AG, which publishes the Medtech Zwo journal. The long-term concept is focused on bridging the gap between start-ups and SMEs. Medtech founders receive tips and tricks regarding the implementation of new business ideas, information about accelerators, incubators,

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Five things to see at the Med-Tech Innovation Expo 2019

Karen Livingstone’s introduction on innovation exchange and SBRI healthcare on day one

Faulhaber and EMS presenting their family of flat brushless DC motors, and BXT for the first time in the UK on stand E28

Midas Pattern Company’s showcase of their high quality, polyurethane RIM mouldings on stand F10

Dr Iain Hennessey’s presentation about the strategy for building the world’s first ‘Living Hospital’ on day one

Medlink UK healthcare business awards which are taking place on the first evening

04:2019 Prototype in development for improved breast cancer detection

lexible coils for magnetic resonance imaging (MRI) are being designed to search for breast cancer, with a prototype currently in development in Vienna following a project funded by The Austrian Science Fund FWF. MRI could be a less risky alternative to X-rays for detecting breast cancer. MRI works by exposing the human body to a static and highfrequency magnetic field, which electromagnetically excites the nuclei of the hydrogen atoms in the body’s tissue. This reaction is then used to record a three-dimensional image from inside the body.

Elmar Laistler, associate professor at the Centre for Medical Physics and Biomedical Engineering at the Medical University of Vienna highlighted the advantages of MRI as, “significantly higher sensitivity and better resolution of the measurement.” However, although the use of MRI would avoid X-rays, it would be a slower and more expensive method of detection. Laistler is currently working on making this procedure for detecting breast cancer cheaper and more convenient.

HOW TO FIND THE BEST AND SAFEST HEALTH CARE APP ON YOUR SMARTPHONE OR TABLET

alford Royal NHS Foundation Trust in collaboration with ORCHA – the Organisation for the Review of Care and Health Applications has launched an initiative to help people lead healthier lives. The trust has created an app library which hopes to provide a solution to the residents of Salford when searching for the best and safest health care app on their smartphone or tablet. The initiative works by subjecting each app to seven tests which assess factors such as security, risks, how user friendly the device is etc. The library can be accessed on the following link - salford.orcha.co.uk “The market is awash with mobile health apps – there are twice as many as just four years ago,” according to Liz Ashall-Payne, ORCHA’s chief executive. “But until now it was difficult for people to navigate app stores to compare different apps, and ensure they are good and safe.”

Check out... The latest episode of the MedTalk Podcast The MedTalk Podcast is back! The most recent episode discusses the now published Topol Review. The review makes recommendations which support the NHS long-term plan and aim to ensure a sustainable NHS. There are also comments from the lead author, Dr Eric Topol. The podcast also highlights the Med-Tech Innovation Expo which is taking place from 15th to 16th May in Birmingham this year. The team highlights why this is the place to be! You can listen to the latest episode on Soundcloud, iTunes and Spotify. 50

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5 THINGS THINGS TO TO CONSIDER 5

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www.phillipsmedisize.com 21.-23. Mai 2019 · NureMberg, gerMaNy www.phillipsmedisize.com Visit us in Hall 9 / Stand 9-337

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