MPN EU Issue 43 by MPN Magazine

EUROPEAN EDITION

MEDICAL PLASTICS news

THE INCREASING IMPORTANCE OF ROBOTS IN MEDICAL MANUFACTURING THE ABHI CELEBRATES 30 YEARS WHAT YOU NEED TO KNOW ABOUT HUMAN FACTORS ENGINEERING

ENGEL REVEALS NEXT LEVEL PROCESS MONITORING AND WHY NUMBERS COUNT ISSUE 43

July-Aug 2018

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CONTENTS July-August 2018, Issue 43

Regulars

Features

5 Comment Lu Rahman looks at some of the issues surrounding the trend for cosmetic enhancement

21 There’s no escape Tekni-Plex outlines how to specify pharmaceutical films with low extractables

7 News focus The Qt Company examines how to reduce time to market for medical devices

23 How robots are revolutionising medical device manufacturing Reece Armstrong investigates

8 Digital spy

28 Is Med-Tech Innovation Expo is the rising star of medtech events? Duncan Wood, CEO of the event, speaks to Med-Tech Innovation News’ Holly Delaney

16 Cover story Engel examines how process monitoring can be taken to the next level using intelligent systems 46 06:2018

30 The clean team Geerd Jansen, the initiator of the PP4CE strategic alliance, outlines the expertise it has to offer

36 Time for change The ABHI is celebrating 30 years. Jonathan Evans outlines the thinking behind the association’s recent change 38 What’s the use? IDC examines usability – what to consider and how it impacts on product development 42 Speaking volumes Nelipak Healthcare Packaging, discusses incorporating innovative design capabilities with volume studies for healthcare packaging optimisation 44 Medtec China reaches international market

34 Rising to the challenge Steris Finn-Aqua discusses challenge testing for COP

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CREDITS head of content | lu rahman deputy group editor | dave gray reporter | reece armstrong advertising | gaurav avasthi head of media sales, plastics & life sciences | lisa montgomery head of studio & production | sam hamlyn graphic design | nat florey-abbotts publisher | duncan wood Medical Plastics News is available on free subscription to readers qualifying under the publisher’s terms of control. Those outside the criteria may subscribe at the following annual rates: UK and Europe: FREE North America: £249 Rest of the world: £249 subscription enquiries to subscriptions@rapidnews.com Medical Plastics News is published by: Rapid Life Sciences Ltd, Carlton House, Sandpiper Way, Chester Business Park, Chester, CH4 9QE T: +44(0)1244 680222 F: +44(0)1244 671074 © 2018 Rapid Life Sciences Ltd While every attempt has been made to ensure that the information contained within this publication is accurate the publisher accepts no liability for information published in error, or for views expressed. All rights for Medical Plastics News are reserved. Reproduction in whole or in part without prior written permission from the publisher is strictly prohibited.

BPA Worldwide Membership ISSN No:

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

I have to admit to being shocked to learn that many of the contestants on the show have had, according to the Telegraph ‘extensive plastic surgery’.

EDITOR’S

comment

Why we need to look at regulation for cosmetic surgery As the media reports the hunt for Dr Bumbum (I honestly never thought I’d be writing a word like that in an issue of MPN), the head of the NHS in England, Simon Stevens, has issued a warning about the broadcasting of cosmetic surgery adverts in the breaks of the increasingly popular ITV2 show, Love Island. In particular he singled out the commercials aimed at young women for cosmetic breast surgery. I like to think I’m pretty aware of what’s going on in the world but I have to admit to being shocked to learn that many of the contestants on the show have had, according to the Telegraph, ‘extensive plastic surgery’. Separately, the British Association of Aesthetic Plastic Surgeons (BAAPs) has commented on this. BAAPS president Rajiv Grover, said: “Such programmes, which are frequently aimed at young people, showcase stars who, more often than not, project and normalise unrealistic standards of beauty – even undergoing multiple procedures following public criticism about their own looks, which is further sensationalised in the media to reveal their surgically-obtained assets.” Grover singles out the “unscrupulous clinics” that are targeting procedures “in a way that commodifies surgery as a quick fix and endangers patients”. He adds: “It is worth noting that many of these clinics have a history of targeting young people using inﬂuencers to promote surgery, for which they have received public criticism – but which has not halted this aggressive and unethical marketing tactic.”

In the same year, the BBC reported on concerns about the safety of the cosmetic industry, which is unregulated. Similarly, last year the Independent reported on a new report from the Nuﬃeld Council of Bioethics that highighted growing concerns, “over anxiety related to unachievable appearance ideals – with young people said to be ‘bombarded’ by promotion of breast implants, nose jobs, and non-surgical procedures”. According to the Independent “the think tank called for all cosmetic surgeons to be properly trained and certified, for a ban on non-medical invasive procedures for patients under 18, and for evidence of safety and effectiveness to be required for implants”. It’s concerning that while the medical plastics sector adheres to intense scrutiny and regulation, putting safety at the forefront of all elements of the supply chain, that it’s clear there’s an element of the cosmetic surgical community that isn’t interested in following suit. Instead, it chooses to focus on an impressionable element of society for financial gain. If there’s one lesson for us all to learn from the search from Dr Bumbum, following the death of a patient, it’s that regulation is just as important for the cosmetic surgery sector as it is for plastic surgery on a global scale.

While programmes like Love Island are promoting cosmetic surgery, figures from BAAPS showed that the number of Britons undergoing cosmetic procedures in 2016 were in decline: “For the first time in almost a decade of relatively consistent growth, cosmetic surgical procedure totals for women and men combined dipped below 31,000 – with 2016’s totals 5% less than those in 2007”.

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NEWS ANALYSIS

Why the UK could lead the way for Industry 4.0 ROGER MAZZELLA, THE QT COMPANY, LOOKS AT WAYS TO ADDRESS THE LACK OF INDUSTRY GROWTH IN THE MEDICAL DEVICE SECTOR

ccording to market research firm Evaluate, the medical device and technology (medtech) market will be worth $500 billion by 2021, and the need for affordable and safe medical devices only continues to increase. This need is primarily driven due to population growth – the growth rate is 1% (approximate 60 million people) currently, and our global population increased from 1.5 to 6.1 billion between 1900 and 2000 alone. Another factor is the rise of new and developing diseases which require aggressive monitoring and treatment methods.

Given these realities, in addition to the rise in industry-wide adoption of present-day, high-tech developments like connected Internet of Things (IoT) devices and artificial intelligence (AI) software, the global medtech market should experience explosive growth – yet this is not the case. Although Evaluate predicts a 5% annual growth rate for the years ahead, many major players in this space had negative growth for the years previously. So what is the cause of this lack of industry growth and advancement and what role can we play to help solve it? WHAT IS THE PROBLEM? The continued innovation and development of med=ical devices and accompanying technologies takes a significant amount of time, money, and resources. Additionally, these projects require various internal and external teams within software engineering, hardware engineering, product management, regulatory affairs, quality, marketing and other fields to work together simultaneously – which is not an easy task. According to ScienceDirect, a platform for peer-reviewed scholarly literature covering healthcare and other science-related industries, the average time-to-market for a medical device falls between three to seven years; moreover, per a Stanford University study, the average cost of bringing an FDA-approved medical product from inception to release was $31 million. For high-risk medical products, the cost would run over $90 million.

Many of these inventive medical devices have no predicate device currently on the market for comparison; as a result, both the costs and go-to-market timeframe often surpass these averages. It is not the lack of technology or innovation that is holding back explosive growth in this market; rather, it is the time-to-market, and the associated costs, which are prohibitive. HOW CAN WE HELP SOLVE THIS? To accelerate the development and approval process of the devices, and speed their time-to-market, medical device manufacturers must immerse themselves in the current regulations practices to gather a clear understanding of the industry applications. Furthermore, manufacturers must stay abreast of changing regulatory practices, specifically those covering development, which can mature even on a month-to-month basis. To successfully drive this initiative, medical device manufacturers should: • Implement better development approaches: Manufacturers need to leverage tools and techniques to develop their medical devices both faster and more eﬃciently while continuing to bring to market safe and effective products. Two key focus areas should be expediting the development process and making the iterative prototyping process easier and more useful. • Implement better regulatory and compliance strategies: Organizations that implement a strong regulatory and compliance strategy early in the development process will notice considerable gains once they submit their product to the various Ministries of Health (ie, FDA, EU, Health Canada, etc.) for consideration. A good regulatory strategy will allow you to properly assess the risk of your device, understand what is required of you based upon the risk assessment, and assemble the proper documentation and evidence needed to prove the device is safe for patients, doctors, nurses, and technicians, and is also effective in its intended use.

• Partner with Industry Leaders: By merging technology expertise with regulatory best practices, medical device manufacturers can streamline the product development lifecycle. By working together, device creators and compliance experts can create diverse partner ecosystems that address resource limitations, navigate global compliance approvals, and elevate product development efficiency. The establishment of these ecosystems is a key step in accelerating time to market for medical devices. The medical industry is evolving rapidly, and Qt is at the forefront of industry professionals who aim to influence the direction of technology innovation, as well as the standards and requirements that govern the sector on every level: local, state, national and global. Qt’s joined program with The Emergo Group supports major and emerging medical markets’ certification and compliance efforts, including the FDA, EU, ISO and IEC, and allows medical device manufacturers to align their product development cycle with the regulatory certification cycle, making their overall time-to-market process faster and more efficient.

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DIGITAL SPY

DIGITAL

spy

www.IDTechEx.com/patches Stick with it: Research highlights pull of wearables skin patches

IDTechEx Research's latest market research report Electronic Skin Patches 2018-2028 covers the entire product ecosystem for smart skin patches. With coverage across 26 application areas, more than 85 companies, 95 different product case studies, historic market data and market forecasts to 2028, it is one of the most comprehensive studies compiled for this emerging product area and reveals significant opportunity, with a forecast for total annual revenues in electronic skin patches to reach over $10bn per year by 2023. Skin patches offer much great choice in terms of device positioning; as long as there is

www.leti-cea.com

MICROFLUIDICS GROUP LAUNCHED TO WRITE STANDARDS TO SPEED DEVICE MANUFACTURE

RESEARCH UPDATE

Electronic skin patches could be described as the ultimate wearable electronic devices. Using electronic components, including sensors and actuators with appropriate processing, energy storage and communication, directly onto the body, they are typically attached using an adhesive. They serve as one of the most direct means to augment the user with technology.

DIGITAL NEWS

area for the patch to be attached, they can be placed there. This is particularly relevant when the sensor requires position close to a certain part of the body (eg. on the upper chest for sensing the heart, around the head for monitoring concussions, etc). A patch also allows for a more consistent means for contact between the device and the body. This may be required for the use of an invasive component such as a microneedle, or in offering a more consistent electrical interface for stable sensor readings. These advantages are particularly relevant in the two largest application sectors for electronic skin patches today: cardiovascular monitoring and diabetes management. The report looks at both of these sections in detail, characterizing the features of the electronic skin patch products being used, the major players, competitive product options and market outlook.

Leti, a research institute of CEA Tech is to develop new ISO standards on microfluidics. Microfluidics involves fluid-handling devices with internal dimensions in the range of micrometers up to a few millimeters. Often referred to as lab-on-a-chip, these portable systems integrate various laboratory functions on a single integrated processor. They are expected to boost point-of-care diagnosis in fields such as health care, and immediate, onsite environmental analysis and monitoring. Following the MFManufacturing project, a European initiative to bring the manufacturing of microfluidic devices to the same level of maturity and industrialisation as electronic devices, Leti emerged as a leader in the launch of an international microfluidics association and the definition of new ISO standards. Nicolas Verplanck, Microfluidic project manager at Leti, will write the microfluidics standards to speed commercialisation of the

emerging technology. “Existing manufacturing processes for electronic devices that have been on the market for many years benefit from well-established standards for electronic components and are easily integrated in the production process of major foundries,” Verplanck said. “In addition to beginning formal discussions on standards for interoperability and other key considerations, our new association, MakeFluidics, is defining standardisation protocols, processes and guidelines to fasttrack development and adoption of microﬂuidic systems.”

DIGITAL DATA

www.raumedic.com

Take the tube: Raumedic expertise use in liver transplant device Raumedic is producing a complex tubing set that simulates vital bodily functions for Metra, a new device for liver transplants from the British firm OrganOx. Within the system, the disposable set helps to keep donor livers perfused outside of the body for up to 24 hours. Shortly after the liver is connected to the transplant device, very quickly, the Raumedic tubing set is filled with the packed red blood cells. The pump head works like an artificial heart to circulate the blood through the tubing from the filter bag to the oxygenator. The

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latter functions as the lung would to enrich to blood with oxygen and maintain body temperature. Syringes supply the donor organ with the necessary nutrient solutions. More than 200 components are produced and assembled for the tubing set. Various silicone and PVC tubes, ECC connectors and product-specific moulded parts are used. All of the individual parts are manually assembled in the cleanroom of the Raumedic HQ in Helmbrechts. Then the tubing sets are packaged, EtO-sterilised and shipped to the customer.

DIGITAL SPY

DIGITAL NEWS

www.solvay.com Reigning glory: Specialty polymer chosen for staple system Solvay, a global supplier of specialty polymers, has announced that its Ixef polyarylamide (PARA) resin delivered the high stiffness and biocompatibility that Reign Medical needed to develop its new Clench compression staple system, a single-use bone staple kit for orthopaedic procedures targeting the hand and foot. Reign Medical’s kit comprises a fully disposable sterile surgical tool set for fixating hand and foot bone fragments, osteotomy fixation and joint arthrodesis. Its design uses a patented threaded hub that allows surgeons to incrementally expand the implant for proper insertion, while retaining the mechanical properties

of the Nitinol staples for continuous compression across the fusion site after implantation. The company specified Solvay’s Ixef GS-1022 PARA, a 50% glass fibre-reinforced grade, for several components: the implant sizer, the drill guide and each part of the implant delivery instrument, including its handle, the saddle on which the staple sits, and the threaded compressor that forces the staples fully open. “Our impetus for this kit was to develop a more robust, single-use bone fixation system than currently available,” said Daniel Lanois, the development engineer for Reign Medical’s Clench Staple System. “Many competitive solutions use lower performing plastics that do not reliably withstand the force required to hold Nitinol staples open, causing the staples to disengage prematurely. After brieﬂy considering polycarbonate and ABS blends, we chose Ixef PARA primarily for its outstanding stiffness, which enabled even the smaller components of the delivery tool to reliably withstand the compression of the staples as well as the torsional, tamping and axial loads applied during fixation procedures.”

PRODUCT UPDATE

www.hartalega.com.my

Give it a hand: Non-leaching antimicrobial gloves launched Hartalega Malaysia together with Chemical Intelligence UK, have announced the European launch of what they are saying is the world’s first non-leaching antimicrobial medical glove. The product, manufactured by producer of nitrile gloves, Hartalega, has in-built antimicrobial technology proven to kill microorganisms in order to prevent the spread of infections. The ‘game-changing’ product – available to private and public health organisations – is the first ever to contain a new active microorganism- killing molecule designed to prevent the spread of bacteria to and from surfaces and people. With the tech built into the glove, it does not need applications of further solutions or chemicals. Bacteria coming into contact will be exposed to the antimicrobial activity which, in independent testing, achieved

up to a 5-log (99.999%) kill within just five minutes of contact. Kuan Mun Leong, managing director of Hartalega Holdings Berhad commented: “In the European Union alone, crosscontamination in hospitals results in 37,000 deaths a year at an additional cost of 7 billion euros. By renovating a medical device that has not been remodelled in over 30 years, our innovation is set to make waves in the healthcare industry and save lives across the globe.”

talking

POINT Surgical mesh in the UK: Where are we now?

SO IN THE UK, THE NATIONAL HEALTH SERVICE (NHS) HAS AGREED TO STOP USING SURGICAL MESH? Yes. The move came about following recommendations from the Independent Medicines and Medical Devices Safety Review which states that there must be an immediate suspension in the use of surgical mesh for treating stress urinary incontinence (SUI). WHY? Chair of the review, Baroness Julia Cumberlege advised that until a set of conditions to mitigate the risks of injury are met, surgical mesh should not be used. The NHS and the Department of Health (DoH) have accepted the recommendation that these conditions should be met by March 2019. The conclusions come following meetings held with women and families who have been affected by surgical mesh procedures. Cumberlege said that the review team had not ‘seen evidence on the benefits of mesh that outweighs the severity of human suffering caused by mesh complications’. WHAT WAS THE ADVICE BEFORE THIS? In 2017, NICE recommended that surgical mesh for vaginal wall prolapse should only be used for research purposes. More recently it was announced that a review into the use of mesh on urinary incontinence in women is being delayed by two months. WHAT ELSE DID THE REVIEW SAY? That surgeons only undertake operations for SUI if they are appropriately trained and do them regularly; every operation is reported to a national database; a register of mesh operations is maintained; reports of complications through MRHA is linked to the register; and specialist centres for SUI mesh procedures are identified and accredited to help those affected by mesh, through removal procedures and other aspects of care. AND CUMBERLEGE? She said: “I have been appalled at the seriousness and scale of the tragic stories we have heard from women and their families. We have heard from many women who are suffering terribly… “At this stage in our review we are not recommending a ban, but a halt to procedures until the conditions we have laid down are met. I am pleased that both the Department of Health & Social Care and NHS England support our recommendation, and I look forward to its quick implementation.”

NEWS FOCUS

ADDRESSING THE TOP FOUR CHALLENGES UNDER THE NEW EU MDR AND IVDR Vicki Anastasi, and Karen Hill, ICON, examine the key challenges associated with the new EU MDR and IVDR

he European Union’s new Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), which replaces decades old legislation, will require manufacturers to make significant changes in product development, data reporting and quality assurance. As a result, device manufacturers can expect higher costs and longer timelines for developing new products, as well as costly new clinical monitoring and evidence generation to recertify many existing products. The regulations will take effect across all member EU states, profoundly affecting business models of all medical and diagnostic device companies within the world’s second largest device market. Here, we outline the top four challenges faced by manufacturers under the new EU regulations, and how ensuring compliance early can lead to maximum success. RECLASSIFIED AND UP-CLASSIFIED DEVICES Under the MDR and IVDR, changes will be made to the way that medical devices are classified, with requirements being increasingly scrutinised based on risk posed to patients. For example, certain devices that come into contact with the spinal cord will move up from class II to class III. Reclassification of devices will require costly certification processes for new products as well as recertification of products already on the market. Both the new MDR and IVDR move from focusing on product approval to the entire product lifecycle, requiring greater clinical evaluation before approval. This will undoubtedly slow device production significantly.

develop the ability to do so. Furthermore, the clinical evidence required for IVDs is more complex than that of many other medical devices. These two factors, combined, will require a great deal of additional time, money and expertise. For medical devices, the new regulations require reassessment of clinical data for devices already on the market. If the data do not meet the new requirements, devices will be required to undergo additional testing to be recertified, increasing the expense of maintaining legacy devices. INCREASED DEMAND ON NOTIFIED BODIES Until now, notified bodies (NBs) have filled a consultative role to help manufacturers meet CE mark requirements. Now, under the new MDR and IVDR, NBs will serve as enforcers of the new regulations, evaluating all medical devices (excluding IVDs) above Class I and IVDs above Class A. This accounts for approximately 90% of all IVDs, up from about the previous 1%, which will increase NB workloads and decrease NB availability. The decrease in availability of NBs to review devices, particularly in higher risk classes, will delay product approvals and slow device entry-to-market. Additionally, with NBs now being required to review a greater volume of data, timelines will be lengthened, increasing overall costs in the device pipeline. The bottleneck created by fewer NBs with higher workloads could lead to long delays before the review process can even commence.

EMPHASIS ON POST-MARKET SURVEILLANCE Finally, under the new IVDR and MDR there will be an increased emphasis on post-market surveillance. This includes proactively monitoring device performance for recertification, annual safety updates for higher-risk class devices, and rapid reporting of safety incidents. While the increased pace and frequency of safety and performance reporting may require significant additional resources for device and diagnostic companies, these requirements can better spot potential issues early in the production cycle. Addressing them can protect patients and reduce manufacturer liability. ENSURE COMPLIANCE EARLY Early transitions to new regulations will be critical in giving products an edge in the market. You can get ahead of the competition by adhering to the following solutions: • Implement a strategic approach early on to ensure compliance and make products more attractive to valueconscious buyers • Seize the opportunity to audit portfolios and eliminate unprofitable products • Partner with a CRO to harness its regulatory expertise These solutions can help medical device and diagnostic companies to begin planning immediately and ensure compliance early. Adjusting will take time, funding and effort – and is critical for future success.

ELEVATED CLINICAL TESTING REQUIREMENTS Another leading challenge faced by manufacturers under the new EU regulations is an increase in clinical testing requirements. Due to reclassification of IVDs, manufacturers that have not previously been required to perform clinical testing will have to

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OPINION

Wireless system can power devices inside the body NEW TECHNOLOGY COULD ENABLE REMOTE CONTROL OF DRUG DELIVERY, SENSING, AND OTHER MEDICAL APPLICATIONS

esearchers from the Massuchusetts Institute of Technology, working with scientists from Brigham and Women’s Hospital, have developed a new way to power and communicate with devices implanted deep within the human body. Such devices could be used to deliver drugs, monitor conditions inside the body, or treat disease by stimulating the brain with electricity or light. The implants are powered by radio frequency waves, which can safely pass through human tissues. In tests in animals, the researchers showed that the waves can power devices located 10cm deep in tissue, from a distance of 1m. “Even though these tiny implantable devices have no batteries, we can now communicate with them from a distance outside the body. This opens up entirely new types of medical applications,” said Fadel Adib, an assistant professor in MIT’s Media Lab and a senior author of the paper. Because they do not require a battery, the devices can be tiny. In this study, the researchers tested a prototype about the size of a grain of rice, but they anticipate that it could be made even smaller. “Having the capacity to communicate with these systems without the need for a battery would be a significant advance. These devices could be compatible with sensing conditions as well as aiding in the delivery of a drug,” said Giovanni Traverso, an assistant professor at Brigham and Women’s Hospital (BWH), Harvard Medical School, a research aﬃliate at MIT’s Koch Institute for Integrative Cancer Research, and an author of the paper. Other authors of the paper are Media Lab postdoc Yunfei Ma, Media Lab graduate student Zhihong Luo, and Koch Institute and BWH aﬃliate postdoc Christoph Steiger.

Adib, who envisions much smaller, battery-free devices, has been exploring the possibility of wirelessly powering implantable devices with radio waves emitted by antennas outside the body. Until now, this has been diﬃcult to achieve because radio waves tend to dissipate as they pass through the body, so they end up being too weak to supply enough power. To overcome that, the researchers devised a system that they call “In Vivo Networking” (IVN). This system relies on an array of antennas that emit radio waves of slightly different frequencies. As the radio waves travel, they overlap and combine in different ways. At certain points, where the high points of the waves overlap, they can provide enough energy to power an implanted sensor. “We chose frequencies that are slightly different from each other, and in doing so, we know that at some point in time these are going to reach their highs at the same time. When they reach their highs at the same time, they are able to overcome the energy threshold needed to power the device,” Adib says. With the new system, the researchers don’t need to know the exact location of the sensors in the body, as the power is transmitted over a large area. This also means that they can power multiple devices at once. At the same time that the sensors receive a burst of power, they also receive a signal telling them to relay information back to the antenna. This signal could also be used to stimulate release of a drug, a burst of electricity, or a pulse of light, the researchers say.

WIRELESS COMMUNICATION Medical devices that can be ingested or implanted in the body could offer doctors new ways to diagnose, monitor, and treat many diseases. Traverso’s lab is now working on a variety of ingestible systems that can be used to deliver drugs, monitor vital signs, and detect movement of the GI tract. In the brain, implantable electrodes that deliver an electrical current are used for a technique known as deep brain stimulation, which is often used to treat Parkinson’s disease or epilepsy. These electrodes are now controlled by a pacemaker-like device implanted under the skin, which could be eliminated if wireless power is used. Wireless brain implants could also help deliver light to stimulate or inhibit neuron activity through optogenetics, which so far has not been adapted for use in humans but could be useful for treating many neurological disorders. Currently, implantable medical devices, such as pacemakers, carry their own batteries, which occupy most of the space on the device and offer a limited lifespan.

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NEWS FOCUS

GOT EU MDR COVERED? LABELS NEED YOUR ATTENTION TOO THE LABELLING OF MEDICAL DEVICES CAN BE A COMPLEX PROCESS. AS EU MDR IMPLEMENTATION HEADS CLOSER, MARK CUSWORTH, PRISYM ID ASKS - WILL YOUR LABEL COMPLY?

t’s widely accepted that the new EU regulation for medical devices will have major implications for the labeling operations of every manufacturer that trades in the EU. EU MDR, which began a five-year preimplementation period in May 2017, will be fully adopted in 2022. However, the first major milestone – the introduction of an EU Database for Medical Devices (EUDAMED) – is on track to launch in 2020. Many of the labelling challenges wrapped up in the regulation will need to be ironed out by then. The clock has been ticking for a year. The labelling of medical devices is already complex, encountering multiple organisational touchpoints across a diverse end-to-end process. It is why labeling has become a mission-critical business system for medical device companies. However, EU MDR brings added complexity and is forcing companies to review their labelling infrastructure as they battle for organisational preparedness. It’s a battle that won’t be won overnight – but it needs to start now. The definition of ‘label’ has, in the past decade, expanded to include items such as multi-language booklets and Instructions for Use (IFUs). EU MDR introduces new rules around these crucial materials. But what does it mean for the sticky label itself?

EU MDR introduces additional information that needs to be included on labels, forcing organisations to design new label templates that make room for data not previously part of the labeling system. It’s both a design and a data challenge, and they must quickly be addressed to avoid a sticky situation. The main headline is emphatic: Every manufacturer that ships products to EU will have to change their labels. Every, single one. The regulation requires that all labels must include a standardised symbol to indicate a package contains a medical device. Although the specific symbol has yet to be determined, it’s unlikely that adding it to the label will pose problems for manufacturers. However, other requirements present more challenges. Many companies will need to rethink their label designs – and the systems they use to support them – if they’re to comply by 2020. Individual requirements are outlined in section 23.2 of the regulation. Though not all of them affect every manufacturer, a number have significant implications. Certainly, every change that requires new information to be added to the label will have operational repercussions. This is particularly the case for products that already have busy labels or where the size of devices leaves little ‘real estate’ to work with. Here are some of the

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most impactful changes, beginning with those with implications for everyone. STICKING POINTS

UDI applied in Europe... UDI has its own dedicated section within EU MDR. The EU’s guidelines are in line with the Global UDI initiative, as are the FDA UDI rules.; all labels must include PI (GTIN) and DI components as textual and barcoded content. Many companies have already solved the UDI challenge due to its requirement in the US. However, companies who do not ship to the US are at the beginning of the UDI journey. MORE SERIAL AND LOT NUMBERS

This change falls under the UDI remit. However, EU MDR requires more products to be serialised than FDA UDI. Every active implantable device must have its own unique serial number. Other implantable devices will require a serial or lot number. Making the shift from batch labelling to a world where individual products need to be married with the right label at the right time is challenging. It requires a data-led labeling system. HIGHLIGHT AUTHORISED EU REPRESENTATIVES Every manufacturer whose registered place of business is outside the EU is required to have a licensed EU representative. Previously, details of that representative were included in the IFU. EU

NEWS FOCUS

MDR requires companies to print that information – symbol, name and address – on the label. WARNINGS & PRECAUTIONS MUST BE ON LABEL

This change will probably have the biggest impact. MDA mandates that all warnings relating to a device must be printed on the label. Previously, these were all included in the IFU. Although the regulation says information can be kept to a minimum – with more detail in the IFU – compliance will require companies to add ‘written text’ to labels, bringing the issue of translation into play. It will also lead to variability in the space such phrases consume, with some languages requiring more room than others. The choice of which warnings need to be included is left to the manufacturer. However, the criteria on which they should base those decisions remain unclear. LABEL MUST INDICATE BLOOD AND TISSUE DERIVATIVES

EU MDR provides regulation for medtech innovations not previously covered by MDD; i.e nanotechnology, the use of computer software or medicines. All devices that incorporate a medical substance or tissues/ cells or their derivatives must clearly indicate this on the label. LABEL MUST INDICATE CMR OR ENDOCRINEDISRUPTING SUBSTANCE

Devices with a presence of carcinogenic, mutagenic or toxic to reproduction (CMR) substances must declare so on the label. These requirements go much further than MDD. INCLUDE REPROCESSING CYCLES

This is another huge data challenge. Under EU MDR, labels for single-use devices that can be reprocessed must detail the maximum amount a device can be reprocessed as well as the number of times the individual device has been reprocessed to date. Manufacturers will need to integrate batch information from their ERP systems and identify data changes to the product definition. This requires capturing information that’s not currently included in the labelling system. Some manufacturers are considering stopping reprocessing single-use devices altogether – a major strategic decision that illustrates the potential impact of EU MDR. EIFUS (ELECTRONIC INFORMATION FOR USE)

EU MDR also introduces requirements around electronic IFUs and the ‘absorption of substances’ that dictate changes in labeling processes. Manufacturers must clearly indicate that the instructions for use are supplied in electronic rather than in paper form. This information must be provided on the packaging for each unit and – in the case of fixed medical devices – on the device itself. Manufacturers must also provide information on how to access the instructions for use in electronic form, such as through the addition of a URL.

MEDICAL DEVICE SYMBOL

Under EU MDR, manufacturers of medical devices must now include a new field on their labels; a clear symbolic indication that the device is a medical device. Again, this requirement goes much further than MDD and further impacts the design, spacing and data inputs to medical device labels LABEL SPACING DIFFERENCES

In order to address the fact that new mandatory content – such as the addition of warning & precautions - is almost certainly going to create congestion, the recent Final Ruling by the FDA no longer requires English text to appear alongside symbols in order to free up label space. This will be worth consideration as its impact will lead to potentially significant label redesign. GLUING IT ALL TOGETHER

Achieving compliance with EU MDR will naturally create labeling challenges for medical device companies. Companies therefore need to ensure their current labeling system is fit for purpose. But they need to do it soon. Although EU MDR will not be fully

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enforced until 2022, the birth of EUDAMED in 2020 means companies could be prevented from registering or re-registering products if they don’t address associated labeling challenges ahead of its introduction. Failure to do so could mean companies can’t market their products in Europe. The most effective labeling systems will be those that give manufactures 360° visibility of all their master data assets – and that provide the core components of label lifecycle management to ensure critical data from across the global organisation is glued together whenever – and wherever – it’s required. Moreover, they will provide a ﬂexibility that enables manufacturers to respond to future changes in regulations. Though UDI and EU MDR have naturally focused thinking, companies should be mindful that regulatory change is imminent in other important markets. With emerging markets now key drivers of growth, companies must ensure that their labeling system is futureproofed to adapt to change in all the regions where they trade. Otherwise, like all good labels, they might just end up stuck.

S E L F - LU B R I C AT I N G LIQUID SILICONE RUBBER FOR H E A LT H C A R E Manufacturing specialized medical components, such as needle-free access valves, o-rings or stoppers generally requires a high-slip surface. With standard silicone, manufacturers need to add a step to their molding process in order to lubricate parts for final assembly. Parts molded with MomentiveÂ´s Silopren* LSR 46x5 SL are pre-lubricated to allow the reduced friction required for mounting parts during final assembly, and the elimination of a step in the molding process. Save time and increase efficiency by making Silopren LSR 46x5 SL series self-lubricating LSR a part of your process today.

momentive.com/health-care Before purchasing or using any Momentive products, please visit www.momentive.com/salesdisclaimer to view our full product and sales disclaimer. *Silopren is a trademark of Momentive Performance Materials Inc. Momentive and the Momentive logo are trademarks of Momentive Performance Materials Inc.

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NEWS FOCUS

Medical device and digitalisation: How to choose a software partner VLADIMIR TIMASHOV, DATAART, TALKS THROUGH THE CONSIDERATIONS OF CHOOSING A SOFTWARE SOLUTION FOR CONNECTED MEDICAL DEVICES

n the age of digitalisation, technology demand grows daily even in highly conservative areas. Smart medical devices and enhanced medical software products such as the AIpowered insulin pump or Embody’s pre-operative planning software allow a seamless user experience, reduce risk and apply new approaches such as AI or VR to help reduce the cost of diagnosis. Many medical device companies are now at the beginning of their digitalisation journey. Some of these manufacturers historically have no software technology capabilities inhouse. At the same time, there are also niche startups in the industry, which are founded by doctors who are struggling with software development expertise and resources. While the option of building an in-house technology department could still be considered, this approach requires significant upfront investment and can extend time-to-market. Therefore, involving a technology partner may be a solution that will offer the required expertise and resources for the longterm journey towards digitalisation. According to ISO 13485 and ISO 9000-family standards, a manufacturer should control the outsourced processes and remain responsible for them. Therefore, if you are a chief information oﬃcer (CIO) of a medical device manufacturer and you’re just starting out on the journey of selecting a software technology partner, you will need to perform due diligence on companies you consider working with. Alongside some of the obvious points like technology expertise and cost estimates, here are a couple of other things to consider as part of the selection criteria:

but rather a service to make it possible to implement a software component for your medical devices in close collaboration with your company’s guidelines, as a step-by-step approach. A supplier should be capable of developing and adjusting their procedures and fit to the manufacturer’s QMS needs. THE SUPPLIER SHOULD BE EXPERIENCED IN MEDICAL DEVICE SOFTWARE DEVELOPMENT Flexibility doesn’t mean the absence of control or avoiding necessary routines. Being a highly regulated industry, medical device development requires thorough approaches when it comes to design controls. Partnering with a technology provider that has all the required knowledge and experience in place makes it possible for the software development lifecycle to be built properly from the very start of the journey and ensures that no important steps are missed. THE SUPPLIER SHOULD BE MATURE ENOUGH TO HELP PLAN AND SET UP QUALITY CONTROLS You will walk hand-in-hand through planning, solution design, risk assessment, development and validation with the supplier you select. Therefore, it’s important to make sure your future partner has the ability,

knowledge and resources to support you throughout the journey. Bringing the technology experts in at the early stages of the planning will help identify and mitigate possible risks related to technology and outline your technology strategy. THE SUPPLIER SHOULD FIT YOUR CULTURE Even though it is not specifically about medical devices themselves, the corporate culture of the parties plays a significant role in building a relationship. It’s helpful to keep in mind that shared values, operational routines and management styles make it possible to avoid conﬂicts, help align priorities easily and significantly speed up the overall process. Due diligence when selecting a supplier is a crucial step in the whole journey. It’s actually the step that affects all the other processes taking place: the lack of a proper selection process can be detrimental to the entire project. At the same time, you should always remember that the initial selection of the supplier is still just the first step – it’s important to regularly ask yourself whether your current supplier still mirrors your goals and adds value. That is not only required by the standard, but it also allows you to make sure the partnership remains meaningful in the long run.

THE SUPPLIER SHOULD BE FLEXIBLE AND ABLE TO ADAPT TO YOUR PRODUCT DEVELOPMENT LIFE CYCLE A supplier’s ﬂexibility makes adaptation possible throughout the entire journey. Each particular medical device has specific risk factors and intended use, alongside compliance with the company’s standard procedures. Therefore, you may not necessarily need a black-box software solution,

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COVER STORY

JOSEF GIESSAUF, ENGEL AUSTRIA, LOOKS HOW PROCESS MONITORING CAN BE TAKEN TO THE NEXT LEVEL USING INTELLIGENT SYSTEMS AND EXPLAINS JUST HOW MUCH NUMBERS MATTER

yclically measured process parameters are used for monitoring and optimising injection moulding processes. In the past, attention was focused on axis movements and the associated necessary forces and times. Now, it’s time to go a step further. Intelligent assistant systems enable plastics processors to generate parameters that are relevant for component quality: injected volume, melt viscosity variation, and pressure deviations during injection.

One decisive success factor for the efficiency of injection moulding processes is a low reject rate. In spite of repeatable machine movements, the quality of the produced components can be subject to certain variations, caused by changes in ambient conditions or the material properties, for example. If such variations are detected and compensated early enough during ongoing production, process efficiency can be improved. Hereby, it is most effective to use signals that are provided anyway by the sensors

The machine control enables the injection moulding process to be monitored effectively by means of quality-relevant process parameters

in the machine. For example, the signals from sensors used for the control and sequencing of machine movements, also permit conclusions about component quality to be drawn. However, it must be noted that these sensors are located further away from the actual processing location than sensors in the mould. Taking these factors into account, intelligent assistant systems are developed. Integrated into the machine control, they even enable manufacturing processes to continuously optimise themselves – a feature that will be standard in the factory of the future! The software iQ weight monitor from Engel provides plastics processors with data informing them for which processes the investment in additional assistant systems is worthwhile. FOCUS ON FILLING PROCEDURE While developing the software, particular attention was payed to cavity filling. The machine operator enters set-points for starting position, speed profile, and a switchover point for the screw movement in the speedcontrolled filling phase. From this data, the machine control system calculates set-point preset values, which the injection controller fulfils as closely as possible.

Apart from injection speed, the resulting pressure curve depends on the amount of melt, the material’s flowability, and the flow resistance. Due to the numerous influencing factors, the injection pressure curve is characteristic for the respective application – and therefore unique. Consequently, this curve is basically suitable for indirect quality monitoring. Already several generations of injection moulding machine control systems offer the possibility of determining process parameters cycle by cycle from sensor signals such as injection pressure or screw displacement and monitoring them during the entire production process. As an example, two usual process parameters for the filling procedure will be examined more closely: Melt cushion and flow number. It can be expected that the melt cushion provides data about shot weight, and the flow number about the material’s flowability and the filling resistance. CLASSICS UNDER SCRUTINY In order to determine the informative values of these two parameters, thin-walled test samples of polypropylene with 0.8 mm wall thickness and about 8.5 g shot weight were produced in a test series using a single-cavity mould. For this, an

Engel Victory 330/120 injection moulding machine was used, which was fitted with an inline precision weighing system for automatic determination of the moulding weight. The question was, how do the process parameters react to variations in viscosity, density, temperature, material quantity or flow resistance? In order to simulate such effects, deliberate changes were introduced in the process. The analysis of the resulting effects and influences on melt cushion, flow number, and component weight showed that the process parameters did not always change in the expected direction (Table 1). For example, it was expected that the melt cushion would change inversely to moulding weight – larger screw displacement leads to a smaller cushion. In the case of flow number, it was assumed that it would mirror the material’s flowability. The figures show the amount of change. If no value is specified, this means that the change was less than the fluctuation range of the number. That the process parameters reacted differently in practice, can be explained by the fact that the flow number is an integral value, for example. The area below the pressure curve not only responds to changes in pressure demand, but also to a shift of the curve along the time axis. Therefore, the flow number not only changes due to variations in melt flowability, but also as a function of the time when the backflow valve closes, as well as the actual amount of material. When interpreting the melt cushion, the problem is that the value only describes how far the screw has moved forwards, but not which melt quantity it has transported. In most cases, melt cushion and flow number are able to indicate changes in the process, but neither process parameter permits conclusions about the cause of the change or its influence on component quality. PROCESS PARAMETERS WITH SIGNIFICANCE iQ weight monitor therefore focuses on other parameters. During every cycle, the software compares the injection pressure curve with a previously defined reference curve, and simultaneously calculates viscosity change as well as injection volume.

TABLE 1. Intentional manipulations of the process and their influence on component weight, melt cushion and flow number. Green: The parameter has changed in the expected direction. Red: The parameter has changed contrary to the expectation.

TABLE 2. Intentionally introduced process changes and their influences on component weight: The process parameters injection volume and viscosity change in the respective expected directions.

Here, injection volume is the primary process parameter. Even if the screw always moves in exactly the same manner. This does not mean that the same melt volume is also always transported. The reason for this is the backflow valve. Before injection starts, the valve is open, so that due to the different pressure conditions, the material is able to flow from the screw flights into the injection chamber. When injection starts, the pressure conditions are reversed. This means that the material flows back from the injection chamber into the screw flights until the valve closes. The software takes these phenomena into account and supplies a value for injection volume that corresponds to the actual shot weight. The second parameter – viscosity change – is significant because viscosity determines melt flowability, which in turn determines the injection volume. Viscosity changes can result from variations in the material batches, the humidity content, or temperature changes.

Thirdly, the degree of conformity between the pressure curve and the reference curve provides valuable clues for additional interference factors during injection. For example, a strongly varying value could mean that the process setup is not ideal or a cold plug has formed. One example illustrates how several factors can influence the injection process simultaneously. Contrary to the reference, the injection chamber contains 1cm³ more melt. This increased melt quantity leads to an earlier pressure increase. With the same viscosity, the pressure curve would correspond to the dashed line. But in this case, material viscosity is some 20 % higher. As if that were not enough, a cold plug has formed in the nozzle, which requires additional force at the start of the injection phase. Even in such a complex case, the algorithm of the iQ weight monitor can detect the respective magnitudes of the three individual effects. The process parameters injection volume, viscosity

change, and conformity of the pressure curves were also examined during the test series mentioned above. The results mirror the changes of the measured moulding weight with the calculated injection volume, although this also includes the sprue (Table 2). Contrary to melt cushion and flow number, the calculated viscosity change reacts exactly as can be assumed. Because the monitoring system calculates the parameters already during injection, ie. before the mouldings can be weighed, it is possible to react to deviations from the set-points during the same cycle, thereby preventing rejects. Engel has also developed a solution for this inline control system. During every cycle, the iQ weight control adapts the switchover point to the actual state, thereby maintaining a constant injection volume. By shifting the switchover point, also the opening and closing times of the shut-off nozzles in the mould are adapted. If the software detects a change of viscosity, the system adjusts the holding pressure to ensure constant shrinkage compensation in the cavities.

EXTRACTABLES & LEACHABLES

THERE’S NO ESCAPE… ROBIN VAN LANDEGHEM, TEKNIPLEX, OUTLINES HOW TO SPECIFY PHARMACEUTICAL FILMS WITH LOW EXTRACTABLES FOR MEDICAL DEVICE LIQUID DRUG RESERVOIRS

here are four major pharmaceutical packaging trends that are driving the need for films with low extractables: growth in specialty medicines; growth in biological versus chemical drugs; increased healthcare costs; and a shift from hospital to home care for self-administered maintenance therapies. These trends explain why the importance of pharmaceutical films with low extractables has increased significantly and will become even more important in the years to come. When selecting plastics for parenteral applications, a number of important design considerations need to be made. Foremost, the structure needs to ensure stability of the active product and offer temperature, moisture and oxygen protection. For liquid formulations, the structure also needs to provide suﬃcient barrier to minimise moisture loss so that the concentration of the active product remains stable. Additionally, there is often a requirement for transparency to allow for visual inspection. Conversely, product components could also be sensitive to light. Careful consideration of these attributes are necessary with the additional

stipulation that the container should not leach anything out into the product. Oftentimes the answer to these environmental and shelf-life challenges is a multilayer film. However, consideration need to be given on how to bond individual layers together, and what manufacturing process is selected. A critical step in the qualification of plastic films for parenteral containers is performing extractables/leachables studies. The EMEA Guideline on Plastic Packaging Materials provides companies with a decision tree for interaction studies based on the particular administration form. The selection of materials as well as the film manufacturing process directly impacts the amount of leachables into the product. Another obvious benefit of plastic structures is that they are shatter resistant, and are capable of infinite medical device design possibilities. When combining all of these requirements for stability, barrier, ﬂexibility, sealing, and so forth, companies are left with a limited number of options with regards to materials and processes. Polyolefins (polyethylene, polypropylene, COC or COP) are typically selected as the product

contact material. Barrier layers for moisture and/or oxygen protection, found in the middle of the structure or used as an exterior layer, are typically EVOH or PCTFE. Polyolefins have been widely studied for interaction with drug products, and resin companies have developed specific product portfolios for medical applications. Polyethylene is a versatile material that is very stable, contains a minimum of additives and shows very good resistance to radiation sterilisation, such as gamma or e-beam. Polypropylene is often selected when there is a requirement for higher heat resistance necessary for steam sterilisation. For some specific drug products, polyethylene and polypropylene have shown some absorption or scalping, leading to alternative material considerations. Attention has also been given to cyclic olefins, such as COC and COP. These materials are of high purity and very inert and have shown excellent results in drug interaction studies. While the increased interest for cyclic olefins is recent, they have been around for quite some time, mostly as a glass replacement for vials and prefilled syringes. Cyclic olefins show high transparency, low

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protein adsorption and high chemical resistance. The disadvantage of polyolefins is that they provide insufficient barrier to prevent moisture loss, which affects the concentration of the active product. In order to guarantee a long shelf life, strong moisture barrier protection is needed. An excellent moisture barrier material is PCTFE, or polychlorotrifluoroethylene, commonly known as Aclar. This flexible thermoplastic film offers high inertness, low extractables and high resistance to heat and sterilisation. The higher the thickness of this PCTFE film, the higher the barrier and the lower the moisture vapour transmission rate. If we consider the same material thickness, PCTFE provides 30 times better moisture barrier compared to PP and 100 times better barrier compared to PVC. Let’s also consider manufacturing processes for multilayer films. In adhesive lamination, each film layer is produced individually, and those layers are then combined by applying an adhesive in between. The preferred manufacturing process is extrusion, which begins with granulates. Through multiple extruders and a multilayer die head, only one pass is needed to produce a multilayer film. In this process, there are no adhesives involved. Instead “tie resins” (large molecules, created by grafting functional bonding groups onto a polyolefin backbone) form a chemical bond between the layers. An extension of the coextrusion process—coextrusion coating—is when multiple layers are extruded onto a film substrate. In many projects for liquid drug reservoirs for parenterals, it has been demonstrated that using tie resins in a coextrusion process leads to a lower amount of leachables into the product.

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ROBOTICS & AUTOMATION

HOW ROBOTS ARE REVOLUTIONISING MEDICAL DEVICE MANUFACTURING REECE ARMSTRONG LOOKS AT HOW MEDICAL MANUFACTURING HAS REACTED TO INDUSTRY 4.0 AND WHERE THE SECTOR SEES ROBOTS AND AUTOMATION HAVING THE MOST IMPACT

he factory of the future is a term that has been thrown around for a number of years now but what does it mean? We entered the fourth age of the industrial revolution – Industry 4.0 – some time ago and manufacturers have explored the range of digital technologies that Industry 4.0 encompasses. One of the biggest technologies used in industrial manufacturing is robotics. Europe represents the second largest market for industrial robot sales and in 2016 there was a 12% increase in the number of sales made using the technology. Whilst it’s difficult to gauge the uptake of robotics within the medical manufacturing industry, figures do show that robot sales to the electronics industry, which includes medical devices, have risen significantly since 2013 . The reason for this? Robotics offer

manufacturers a way to streamline production lines, helping to increase productivity and optimise workflows. Within medical manufacturing, robots are being used across the entire production line – from assembly to inspection and packaging. Due to the strict regulations device manufacturers are under pressure to reproduce the same product, under the same stringent conditions, with little downtime. To keep up with the pace of innovation, medical manufacturers must be able to change manufacturing lines when new products are needing to be developed. Robotics and automation offer manufacturers modular systems that promote efficiency and workflow. Motion control systems help production lines assemble and move medical devices in a flexible workspace; meanwhile control sensing and vision-guided systems can help manufacturers not only pick-and-place devices but ensure product safety by

scanning and verifying barcodes . Take for example Kuka’s KR Agilus six-axis robot. Designed for high-working speeds in confined spaces, Agilus can be installed on the floor, ceiling or wall, enabling manufacturers to maximise their workspaces while reducing cycle times and increasing production quality. To be used within a number of sectors including cleanrooms, Agilus aims to ensure continuous productivity by never needing a change of lubricant. Looking towards the

2018.9.26-28 | Shanghai 5 reasons to attend Medtec China 2018 Access to more than 2,000 global suppliers of medical device design and manufacturing from Medtec World Free access to advanced products/technologie/ service for the medical design and manufacturing industry Resolve key technical challenges and problems in the processes of medical product development and manufacturing The opportunity to explore regulatory updates in China, the US and the EU Access to market trends and forefront business opportunities

The Leading Exhibition for Medical Device Design & Manufacturing in China Visit：

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Exhibit：

Linc Cai T: +86 21 6157 7217 E: Linc.Cai@ubm.com

ROBOTICS & AUTOMATION

its Shawpak thermoforming sealing machines. The machine, which is designed for cleanroom environments, uses an innovative forming, packing and sealing process which is now carried-out on a drum, rather than a linear conveyor system. Production benefits come from the fact that the machines start at only 1.5 metres and can occupy less than 2m2, representing a reduction of up to 95% compared to traditional form fill sealing (FFS) machines . Ivor Rowe, technical manager at Riverside Medical said: “A comparable FFS machine can be anywhere from seven to 20 metres in length depending on the packaging process requirements, occupying a working space of up to 40 m2. As a result, a given cleanroom space can fit six times more packing machines with a Shawpak design, increasing both productivity and throughput.” Here in the UK, manufacturers seem reluctant to deploy robotic systems. A government report last year showed that the UK is lagging behind international manufacturing competitors. The Made Smarter Review states that for every 10,000 employees the UK only has 33 robots. Compare this to 93 in the US and 170 in Germany and it’s easy to see why the UK is below other countries in terms of productivity .

A Mitsubishi Electric robot arm on a packaging machine, inserting devices into blister packs ready for sealing. [Source: Mitsubishi Electric Europe B.V.]

realms of human and robot collaboration, Festo has designed a workstation that combines self-learning systems with artificial intelligence (AI) and robotbased automation. The company’s BionicWorkplace enables humans to work alongside a bionic robotic arm in a fully customisable workspace. Workers are supported through a range of systems and peripheral devices which help to relieve them of tiring or hazardous tasks. Unlike other robotic systems, which entirely replace the human element, BionicWorkplace is made for those industries in which the human worker cannot be replaced. The system is able to learn from every action initiated from its base and can optimise itself to become consistent in its production. Better yet, the system’s processes and skill can be transferred to other BionicWorkplace’s and in the future, Festo anticipates it will be

possible to integrate multiple systems in a global network in which orders are placed and carried out autonomously by the machinery. Sterility can be a key consideration for some medical device manufacturers. Neal Welch, business manager for life science at Mitsubishi Electric, explains: “Automation has always lent itself to the manufacture of mass produced disposable medical devices and the bulk processing of samples - for two main reasons; initially for speed and repeatability, and then because human presence poses one of the biggest contamination risks in a clean production or processing environment.” Derby-based Riverside Medical Packaging is using robotics to increase productivity. The company turned to Mitsubishi Electric to help it develop

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Indeed, a survey by Protolabs of 301 senior business decision makers in the UK manufacturing industry showed that automation isn’t having that much of an impact on organisations’ business models. The survey showed that 15% of respondents said they have no automation in their manufacturing services, and one in 10 (9.7%) expect no or only a little (15%) increase in automation in their business over the next five years. The statistics are worrying, especially when you consider the technological advances being made to benefit manufacturers. However, initiatives in the UK such as LCR 4.0 are aiming to help companies utilise Industry 4.0 technologies to modernise manufacturing lines. The project, which is part-funded by the European Regional Development Fund (EDRF), aims to place Liverpool City as a modern and collaborative hub for manufacturing by connecting SMEs with other businesses and offering access to practical support through a dedicated LCR 4.0 team.

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ROBOTICS & AUTOMATION

Currently operating on a local level within Liverpool, the initiative is expected to create 60 news jobs in supported businesses; deliver fully subsidised support to 300 SMEs in Liverpool and enable collaborations between 200 businesses and partners. Last year, it was announced that LCR 4.0 has already delivered support to almost 100 businesses in Liverpool and is being touted as one of the most important projects in the UK for helping to promote Industry 4.0 to manufacturers. Mentioned in the Made Smarter Review in 2017, LCR 4.0 still needs to do more, “to integrate districts from all corners of the Liverpool City Region,” according to Simon Reid, sector manager for advanced manufacturing at the Liverpool City Region LEP. With LCR 4.0 already showing signs of success, a similar nation-wide initiative might be the next logical step if the UK wants to boost its manufacturing production and reach targets set out in its Industrial Strategy. German-based Siemens is a big advocate of the need to push towards more modern methods of manufacturing. Despite a number of barriers (digital skills, collaboration, cyber-security) currently preventing a successful transition to Industry 4.0, Siemens’ believes that manufacturers must adopt digital practices if they are to stay relevant and competitive.

Through the company’s Process Industries and Drives Division, Siemens has helped companies including Evonik and Covestro increase their digitisation capabilities. Siemens realises that the vast amount of data that companies now generate needs to be utilised if businesses are to optimise not only production lines, but entire operating plants. Indeed, Siemens now offers its services to businesses, stating it can create a ‘digital twin’ of manufacturers’ plants that can be used to map and optimise product lifecycles. With robotics and automation systems starting to be implemented across manufacturing sites, Siemens offers companies modular production capabilities through which they can quickly adapt to constantly changing requirements. Paul Kendall, industry sector manager at Festo agrees that Industry 4.0 and the technology it encompasses are vital to the future of manufacturing. Whilst robots have been around to years, Kendall says that the ‘latest innovations and deployed solutions are now adding more value than ever’. “Based on the core elements of Industry 4.0, modern automation systems are providing more benefits and added value through digitalisation, connectivity and the use of cyber physical systems,” Kendall says. These technologies are enabling manufacturers to capture more data, access systems remotely, view online diagnostics and add production data behind devices that are being built.

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In addition to this, ‘new technologies entering into the manufacturing space are adding value far beyond the physical automation itself,’ Kendall says. “In the future, these core technologies combined with adaptable automation and agile workﬂows will provide opportunities to achieve high volume batch production costs for low volume batch manufacturing bringing personalised devices and products ever nearer to the consumer.” Kendall said. Neal Welch, business manager for life science at Mitsubishi Electric, believes that the Industrial internet of Things (IIoT) and Industry 4.0 are the logical next steps for manufacturers. “The next stage is the integration of IIoT and Industry 4.0 style solutions where robots and machines are interconnected in a way the transcends their physical location. Mitsubishi Electric for example, is already using Edge Computing and various forms of AI such as the IBM Watson online AI service, built-in machine learning and physical teaching functions for establishing complex processes quickly without having to hard code routines and parameters as we have done in the past. “This level of digitalisation has already allowed us to create interactive safety glasses with augmented reality displays for routine servicing and voice activation for robot function control, so it’s safe to assume that in the future, we will be looking at our robots in a different way and talking to them about what they are doing,” Welch said.

MED-TECH INNOVATION EXPO

IS MED-TECH INNOVATION EXPO THE RISING STAR OF

MEDTECH EVENTS? MED-TECH INNOVATION EXPO, THE EVENT FOR MEDICAL DEVICE DESIGNERS, MANUFACTURERS AND ENGINEERS, IS MOVING. RISING UP EVENT RANKINGS IT NOW BOASTS A NEW VENUE TO MATCH ITS GROWING STELLAR STATUS

On the back of the latest successful event in April, organisers of Med-Tech Innovation Expo, Rapid Medtech Communications (part of the Rapid News Communications Group), announced the show’s relocation to Birmingham for 2019. Med-Tech Innovation News’ Holly Delaney sat down with Duncan Wood - chief executive, to find out more about the future of the event. WHAT WAS BEHIND THE DECISION TO MOVE MED-TECH INNOVATION EXPO OUT OF THE RICOH ARENA? WHY THE NEC?

DW: It’s really simple. 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.

ambitions. The industry can see that we’re committed to it, and this was important to establish before we made the move. For sure there is always a little resistance to change, particularly one that is so significant, but it’s our job to understand that and hold hands during the move.

We already have a great relationship with the NEC and have run other group events there such as TCT Show and Interplas for many years. So, between that relationship, the easy accessibility for the venue by road, rail and air, and the opportunities for further growth it was an obvious choice.

We’re going down a path we know very well; in 2011 we moved TCT Show from the Ricoh Arena to the NEC, and now it is a leading international event with over 10,000 attendees and 300+ exhibitors annually. We know the ground here and have executed a similar transition before very successfully in a much smaller industry.

HOW HAS NEWS OF THE MOVE BEEN RECEIVED? DW: I think overall thefeedback has been positive towards our

WHY HOLD THE EVENT IN BIRMINGHAM? DW: Aside from the fact that the NEC is really the only venue that can

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MED-TECH INNOVATION EXPO accommodate our ambition for the event, Birmingham is England’s second city. It’s no more than a 3-hour journey for 75% of the UK and has an airport that averages 292 domestic and international flights daily - this means Med-Tech Innovation Expo 2019 will be easier to get to for both UK and international visitors which in turn means better return on investment for our exhibitors. A greater international audience will also allow us to show off the UK’s expertise in this sector and drive the industry forward by making the event a focal point for the sector. The Midlands is a hub of engineering excellence for the UK. A great number of our core attendees - designers, engineers, manufacturers, R&D experts and other professionals involved in the design and manufacture of medical devices – are based here. There are 280,000 people employed in manufacturing in the region and 62,000 in advanced engineering. HOW DO YOU FEEL THE MOVE WILL BENEFIT ATTENDEES? DW: It’s quite easy to list all the positives the NEC offers. We’ve already touched on accessibility for both national and international visitors. Alongside this is a greater choice of onsite hotels, more restaurants and of course the ability we now have to craft a much broader event with more exciting aspects to it. We’ve already confirmed plans to expand the breadth of the event with the addition of four new exhibition zones focused on digital healthtech, medical plastics, pharmaceutical manufacturing technologies and early stage innovations. Alongside this, a wider content and conference programme will increase the learning opportunities in all areas of the technologies we cover.

Med-Tech Innovation Expo will continue to bring together designers, engineers, innovators and manufacturers from the medical, pharmaceutical and healthcare sectors to source products, explore new ideas, understand emerging technologies and do business with companies representing the entire medical device supply chain from ideation, through design and validation, to manufacture. The solutions on the show ﬂoor will help them design the next generation of medical and pharmaceutical devices. AND EQUALLY WHAT DOES THE MOVE OFFER FOR YOUR EXHIBITORS? DW: The accessibility, accommodation and eating options hold true for exhibitors

too, but the most important news for them is that we’ve been able to reduce our rate card for exhibiting by a significant amount. This immediately saves our exhibitors almost £2,000 on the cost of a 9m² stand. This is our investment in the industry, allowing more exhibitors to take part and enabling returning exhibitors to consider larger stands. We’re committed to delivering increased ROI - reducing exhibition costs and increasing attendance is the simple equation that will deliver this. The NEC is a much larger venue, what will this mean for the day-to-day practicalities of exhibiting? DW: The NEC certainly comes with bigger halls and the possibility of multiple events going on at the same time, so there will be a few policies and procedures for exhibitors to adjust to. We know change can be daunting, especially if it means spending more time adhering to policy, but we’ve run events at the NEC for years. We know what to expect and are more than capable of making the set up and break down as easy as possible. Our highly experienced operations team

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will make sure exhibitors are correctly prepared and given all the guidance they need. FINALLY, WHAT DOES THE FUTURE LOOK LIKE FOR MEDTECH INNOVATION EXPO? DW: I’m quite confident that 3 years from now, when the expo is where we expect it to be, our exhibitors will be more than happy with the growth the event has provided for their businesses. There will be very little nostalgia for the days when it was smaller! We could have stayed at the Ricoh with a smaller show, but this move is about ambition. When you consider the scale of the £27bn UK and Irish medtech industry, it deserves a bigger platform. We mustn’t be afraid to grow and step onto the world stage. It’s time the UK had a show commensurate to the size of the market, one that can promote our expertise to the rest of the world. MED-TECH INNOVATION EXPO WILL BE HELD IN HALL 2 OF THE NEC, BIRMINGHAM (UK) FROM 15 – 16 MAY 2019. FOR MORE INFORMATION, VISIT WWW.MED-TECHEXPO.COM

CLEANROOMS

The clean team PROFESSIONAL PARTNERS FOR CONTROLLED ENVIRONMENT (PP4CE) IS A STRATEGIC ALLIANCE OF SPECIALISED COMPANIES FOR THE CLEANROOM MARKET. GEERD JANSEN, THE INITIATOR OF THE STRATEGIC ALLIANCE, OUTLINES THE THINKING BEHIND THE INITIATIVE AND THE EXPERTISE IT HAS TO OFFER

IMPRESSION OF A CLEANROOM WITH PERSONAL LOCK-IN COMBINATION WITH A NUMBER OF RECURRING PARTS IN A CLEANROOM (FURNITURE, MONITORING, LAF CABINETS ETC).

GLOBALISATION IS KEY More and more companies have become commercially active on an international level. We can see that this has happened in the food, pharmaceutical, semiconductor, and also the medical device sector. Geerd Jansen says: "More and more we see a global operating production-division. The management of such international groups then formulate objectives such as meeting high, but above all continuous and geographically equivalent quality requirements, continuity of production (preferably 24-7), innovative solutions to problems and of course good value for money. Global partners, for production machinery, raw materials or packaging, are therefore often preferred to local suppliers." So far nothing new! Let's see what the PP4CE initiative means in this increasingly important globalisation in relation to the objectives pursued by the stakeholders of these international players.

A CHANGED WORLD AFTER THE LATEST CRISIS... There are many changes taking place in the global business community. Some of these changes are due to the last economic world crisis. One important change is the implementation of risk management balanced with the increasing use of strict regulations.

globally, where many things were previously regulated at a national level. In 2017, the WHO approved a regulation that will introduce new rules for the marketing authorization of medical devices and in-vitro diagnostics, in the coming years.

"Management has learned from the crisis period, that started about 10 years ago. Among other things, the lesson that risk-management - as a link in identifying, quantifying and limiting or rather completely eliminating risks – clearly deserves more attention. It is not only the financial world that has learned from this. The institute ISO has also implemented risk management in the HLS (High Level Structure) of its management systems,” says Jansen.

Jansen: adds "Because of the new rules, more products are classified in a higher risk class. For manufacturers this may mean a series of changes. Both design, production and distribution processes may need to be adjusted and tested more heavily by Notified Bodies. This also means that the facility, where production and logistics take place, may have to meet higher requirements. GMP regulations, initiated by the FDA, as well as the ISO 13485 - 2016 standards committee, will ultimately anticipate this."

Universal standards for the design, production, export and sales of various product segments are increasingly being implemented

TABLE 1: 10 MAJOR RISKS OF GLOBAL BUSINESS. PP4CE offers turnkey solutions for facilities with controlled

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CLEANROOMS

More surprising, Jansen says is that the controlled environment facilities in which the production and / or logistics take place, are often designed, delivered and installed by local suppliers.

THE TEN MAIN CONCERNS OF THE GLOBAL BUSINESS COMMUNITY ARE: 1. Reputation damage 2. Economic declines or slow economic recovery 3. Increasing competition 4. Changes in legislation and regulations 5. Cyber crime 6. Lack of innovation or inadequate with customer needs 7. Attract and retain inability top talent 8. Interruption of business operations 9. Political risks and uncertainties 10. Legal liability

“I do think the management is taking risks by not using a similar reliable technology, proven to fill in the needs of the organisation and based on uniformity, easier and cheaper in maintenance. Traveling throughout the world visiting factories, I liked to see similar working environment knowing the facilities and procedures where tested and proven concepts!" "The strategic alliance, PP4CE (Professional Partners for Controlled Environment), offers these conglomerates an international platform for innovative turnkey solutions in controlled environment environments. Not only for the realisation of new construction but also for a responsible maintenance concept that guarantees continuity. If necessary, implemented in an ISO 55001 Asset Management care system. Executed by flexible, professional, reliable and honest companies and their employees!"

Source: The world's largest insurance broker and risk advisor AON, conducted its biennial research 'Global Risk Management Survey' in 2017. With international research, for which more than 1.800 CEOs, CFOs and risk managers have been surveyed worldwide, the most important risks for the business community are charted.

Jansen concludes: "With the joint expertise and a global network of all PP4CE partners, PP4CE will be able to create an international platform for the ever-growing controlled environment market segment. The customer has one point of contact, which leads the entire process from design qualification to the implementation of the commissioning and qualification plan. “The PP4CE approach ensures that no unnecessary loss of time occurs, communication with various parties becomes superfluous. The cooperation with the client is agreed in a clear contract, in which the User Requirements Specifications (URS) as well as the expected qualifications are described, including the agreed time plan for development and realization. A time plan which in principle is always realised by PP4CE.”

PROFESSIONAL PARTNERS FOR CONTROLLED ENVIRONMENT PP4CE is a collaboration between experts from different technological areas, including Stulz one of the world's leading companies in energy-efficient temperature and humidity management solutions for mission-critical applications, as well as general HVAC technology; and Brecon International, a Dutch company that represents more than 25 years of experience in designing and building cleanroom technology.

environment requirements, on an international level. Jansen explains: “In the light of the 10 biggest concerns of the global business community, we see a number of issues that PP4CE regularly faces as an organisation. Examples include customer questions regarding current legislation and regulations, innovative solutions or ideas in the design phase, how to prevent interruptions in business operations and of course the legal liability is always an issue, whether it concerns environmental or safety or product liability! In all cases, reputational damage is the number one risk, especially for markets such as the healthcare or pharmaceuticals.

OTHER PARTNERS INCLUDE: • • •

• • •

Camfil, air filtration expert; Assa Abloy, global supplier of entry technology; Bolidt, expert in the development, production and installation of innovative synthetic bonded ﬂoors; Mennens Cleanroom Cranes, a manufacturer of special CE lifting equipment; Van Aken Architects, a provider of architectural services in the CE area; Denios, specialist in laminar and cross-ﬂow booths as well as LAF cabinets

"Our clients are often companies with large responsibilities, globally active and listed on a stock exchange. Compliance issues therefore always have priority, I know that from my time as a member of the board of directors at BASF Coatings AG.”

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The Event for

25 26 27 SEPTEMBER 2018 NEC, Birmingham, UK

Being recognised as a world-class company is only achieved by constantly improving every part of your design-to-manufacturing process chain. The pace of development in technology, materials and software is incredible and with over 300 cutting edge exhibitors that CAN help you enhance your design and manufacturing process, it is no surprise that more than 10,000 professionals from product development, engineering and manufacturing functions choose to attend the TCT Show every year. Join them this September.

Whatever your mission, find your insights, intelligence and inspiration at TCT Show.

SHOW

STERILISATION

RISING TO THE CHALLENGE VAPOURISED HYDROGEN PEROXIDE (VHP) STERILISATION CHALLENGE TESTING FOR COP (CYCLO OLEFIN POLYMER) CONTAINER MATERIAL, BY JUHA MATTILA, STERIS FINN-AQUA

ow temperature terminal surface sterilisation by Vapourised Hydrogen Peroxide (VHP) is becoming more common in pharmaceutical and medical device manufacturing applications. This development can be seen with sensitive drug products, such as ophthalmic injectables, or other heat or radiation

sensitive medical devices. VHP is compatible with most plastic materials used in the industry, but there may still be some knowledge gaps particularly when dealing with novel applications or when a specific new material is being introduced. A terminal surface sterilisation process must not alter the

device or packaging properties, to ensure that biocompatibility, device integrity, usability, and/ or product shelf life are not compromised. Exposure to sterilant should be controlled and maximum allowed processing temperatures not exceeded. Also, the sterilising agent must not penetrate inside a primary container of a drug delivery

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STERILISATION

device. Cyclo olefin polymer (COP) is used as material for syringes and other drug delivery devices for prefilled drug primary containers, syringe barrels, vials and bottles. COP syringes have specifically been successful when employed with sensitive protein drugs. Because of this, there have been several inquiries about compatibility of COP syringes and VHP (VH2O2) for use in drug delivery devices’ surface terminal sterilisation process. One of the concerns has been to understand if VHP vapour can in any way penetrate the syringe wall - as it was suspected that it might be possible for oxygen (O2) to penetrate due to lower oxygen barrier properties of COP and considering that VHP breaks down to water vapour and oxygen during sterilisation exposure. Such applicationspecific material penetration studies for VHP and COP were not available. Steris Finn-Aqua and Zeon agreed on a case study and developed a sterilsation challenge test plan. This plan included the selection of a suitable COP container for testing, developing a low concentration detection method for any hydrogen peroxide residual in WFI (water

for injection) filled sample containers, and programming a series of sterilisation challenge test cycles and conditions to achieve suﬃcient and representative VHP sterilant exposure under deep vacuum. An analysis method by spectrophotometry using Toluidine Blue to determinate low concentrations of hydrogen peroxide in WFI water samples was developed by VTT Expert Services, Finland. The calibration curve created for the analysis method provided a detection limit of 100ng/ml (ppb). Relatively large volume COP containers (Zeonex 690R, V=100 ml, Di=32,5mm, L=120mm, wall s=1,3mm) were selected to expose as large a surface area of material to VHP sterilisation as possible, to ensure penetration testing to be representative. A total of six container tubes were used in the sterilisation exposure testing such that a set of two tubes were exposed to one, three, and five times the exposure time of a VHP sterilisation cycle. Test containers were placed in the chamber without any packaging. Positive and negative control samples were also provided to the laboratory as part of sampling. Each container was filled with 50ml of WFI and the tube ends were sealed with applicable

glue, rubber cap and tape to avoid leaking inside. Vaprox 35% hydrogen peroxide sterilant was used in the VHP terminal steriliser (Steris VHP LTS-V-91515-S7) of 2.0m3 chamber volume including a mock-up load for creating representative cycle conditions. The most challenging sterilisation exposure cycle was configured to be equal to five consecutive deep vacuum (4 mbar), low temperature [+30…32 °C] sterilisation exposures resulting in a total of 90 injection pulses, 87g of hydrogen peroxide in vapour state, 180 minutes of exposure time and 5h 29min of total cycle time. Presence of hydrogen peroxide in post-exposure spectrophotometric analysis of the WFI samples was below the spectrophotometric analysis detection limit of 100ng/ml. Measurements by a Draeger hand-held peroxide sensor device were also taken directly on the tube surfaces right after each cycle’s end. The highest measured surface reading was 0.1ppm. All other measurements were below detection level of the sensor. No discolouration was detected either. Low levels of surface residue on containers after the sterilisation cycle indicate that COP’s hard and glass-like surface does not absorb significant peroxide.

STERIS FINN-AQUA AND ZEON AGREED ON A CASE STUDY AND DEVELOPED A STERILSATION CHALLENGE TEST PLAN. THIS PLAN INCLUDED THE SELECTION OF A SUITABLE COP CONTAINER FOR TESTING

THE MOST CHALLENGING STERILISATION CYCLE GRAPH

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ABHI

TIME FO R

E C H A NG

THE ABHI IS CELEBRATING 30 YEARS. LOOKING TO CONTINUALLY IMPROVE ITS OFFERING, THE ASSOCIATION HAS RECENTLY UNDERGONE CHANGE TO REFLECT THE EVOLVING FACE OF THE HEALTH SECTOR AND ITS CONVERGENCE WITH DIGITAL TECHNOLOGY. JONATHAN EVANS EXPLAINS

his time last year, the ABHI started a process of change. Following a series of interviews with members, health technology companies and respected leaders in the sector, we looked at the future direction of our industry. What became clear was that technology and health industries are converging – brought together by trends like informatics, data, AI and digital health solutions. As the lines between medical technology, devices, diagnostics and digital health all blur, new companies are entering the market seemingly every week. With businesses increasingly ‘digitalising’ their products and services, we at ABHI feel that the most apt description for this rapidly evolving sector, is ‘healthtech’.

It is why, in our 30th year as an association, we decided to recognise this by changing our name to the Association of British HealthTech Industries. This evolution signals our intent to focus more on how technology improves health, not just how it treats disease. The numbers confirm this too. In the latest Oﬃce for Life Sciences annual Strength and Opportunity report, digital health is the now the single biggest employer within the broader healthtech industry. 10,000 people in the UK make up the sector, a sharp rise of 11% on last year’s figure. Truly highlighting the sector’s ﬂedgling nature, over half of digital health companies were formed within the last decade, and the market’s growth shows no sign of slowing down.

In her recent speech where she announced an additional £20billion cash injection into the NHS, the prime minister outlined the need to focus on prevention, not just cures. In a world where health systems are facing unprecedented demand, there is a need to utilise these technologies to manage health in a holistic manner, rather than simply treating diseases, which can often be done too late, and at a high cost to the system. Through patient monitoring, real time data analytics, predictive algorithms, and the emergence of AI, healthcare professionals, patients and providers now have more power than ever to monitor, manage and deliver effective healthcare. The crucial factor in all of this, is the ability to shift care away

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ABHI

in 2017, the hub is in the process of being expanded, with applications for a second cohort of members to join now being accepted. In an increasingly connected world, the ABHI is always on the look-out for opportunities that allow members to grow their business in the UK and overseas. Whilst companies seek clarity around Brexit, the healthtech industry is resilient. For many, it’s business as usual and exports are strong. ABHI HAS BEEN WORKING ON INITIATIVES LIKE THE ABHI INNOVATION HUB AT THE DELL MEDICAL SCHOOL IN AUSTIN, TEXAS. OFFERING UK COMPANIES A BASE TO GROW THEIR BUSINESS STATESIDE

The challenges the US faces are not unique, but the size of the country, its technologydriven cities and world-class academia, all mean one thing: it is the largest healthtech market in the world.

from the traditional clinical setting and move it to the home. Done well, it can empower the patient and alleviate strain on the system.

Over the past decade, we have grown our US activities, to provide tangible opportunities to UK companies seeking to increase their operations stateside. Taking a state-by-state approach, we have gradually expanded our programme across the country, developing a network of connections within local health systems, that include clinical heads and c-suite leadership teams. We have also cultivated relationships with Chambers of Commerce, key business groups and leading technology companies.

These solutions require investment and naturally, quality products may not necessarily mean they are the cheapest, but the overall savings and value to the healthcare system far outweigh that initial investment. It’s always better to take a value-over-price approach if long-term savings are to be realised. In the last few years we have seen a boom in the number of wearable devices and apps, from equipment that monitors heart rate and blood pressure, to programmes that can track calorie intake and exercise. Such innovations allow a person to make changes to their lifestyle and plan a healthier future. It empowers the user to take ownership of their health and also acts as a preventative measure for any potential future health issues. Partnered with other monitoring systems and powered by real-time data, patients and medical professionals can quickly spot changes or new trends that require immediate attention, keeping small problems in the home. This avoids visits to the emergency room, costly treatments and long-term social care. It is where technology really comes into its own, as the potential savings are enormous.

The Texas Innovation Hub is the latest offering in this comprehensive US market strategy and to support this, 2018 has seen ABHI grow its international function. With experienced industry figures joining the association to provide additional resource to companies looking for support with their export strategies, ABHI’s international division now boasts a wideranging menu of opportunities and support. The recent launch of the ABHI SME Forum was another important milestone for the

association. The healthtech sector is dominated by smaller businesses and this is reﬂected in ABHI’s membership, with 89% of members falling in this category. With this in mind, we have created a community of small and medium sized health technology companies to give a stronger voice and representation for this crucial engine of innovation. Yet, cut ABHI in half and you will see regulation running through it. It was the genesis for ABHI’s creation 30 years ago and remains, for many members, the single most important reason for joining the association. Our industry is heavy regulated, and rightly so. Through our internal expertise, we help companies to understand this framework, so that patients can access healthtech safely and quickly. Through insisting on the highest professional standards and ethical behaviour, driven by our Code of Ethical Business Practice, our work ensures healthcare professionals and the public have confidence in the integrity of our industry. It is critical that the healthtech industry is recognised as a trusted partner in healthcare. And as we look to the future, it is critical that the industry’s trade body reﬂects the companies for which it is representing. By taking the lead through a number of initiatives, such as our Women in Leadership events, we are actively working to guide our sector to improve diversity and inclusiveness right across the sector. These changes are just the start. ABHI is uniquely positioned to build connections across the healthtech sector, giving our industry the opportunity to grow in the UK and beyond. Together we can provide a louder voice to champion the power of healthtech to transform healthcare and improve patient outcomes.

NOW 30 YEARS OLD, THE ABHI DECIDED TO RECOGNISE THE INCREASING ROLE OF DIGITAL TECHNOLOGY BY CHANGING ITS NAME TO THE ASSOCIATION OF BRITISH HEALTHTECH INDUSTRIES

With patients taking ownership of their own health more so than ever before, there is a genuine shift happening in healthcare. It’s not surprising then, that large technology companies are investing heavily in their healthcare side of the business. With this in mind, ABHI has already been working on bringing the health and technology industries together with initiatives like the ABHI Innovation Hub at the Dell Medical School in Austin, Texas. Offering UK companies a base to grow their business stateside, the hub is part of the ABHI’s US Accelerator Programme. It provides companies with access to in-market experts and clinicians, ABHI’s highly developed Texan network, access to US trade missions and a range of other benefits. The initiative has proved so successful that following its launch WWW.MEDICALPLASTICSNEWS.COM

HUMAN FACTORS ENGINEERING

WHAT’S

THE USE

NICK CHUBB, IDC, EXAMINES USABILITY – WHAT TO CONSIDER AND HOW IT IMPACTS ON PRODUCT DEVELOPMENT

WHAT IS USABILITY? Usability is about one thing and that is the quality of interaction between people and products. It’s really that simple. However, the process involved to ensure this quality is less straightforward. Also, to clarify, usability is human factors. They are one and the same. The task of increasing the quality of interactions between people and products can be driven by regulation. For example, making a product safe to use. However, the commercial drivers of making the product more efficient and satisfying to use are just as significant.

It’s important to know that usability isn’t something that is only applied to medical products, nor is it something that is only applied to complex devices. Something as simple as a tin opener has progressed dramatically since the mid-1900s with regard to usability, as has the folding of a baby stroller and the user experience of many software applications. It’s all around us. HOW CAN IT IMPACT THE OUTCOME? When usability is applied poorly during the product development process, the consequence is what we call ‘use errors’. Put simply, a use error is any situation

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HUMAN FACTORS ENGINEERING

where the outcome from using the product is different from the intention. Wherever possible, usability aims to minimise the existence of use errors. For example, if a tube is not connected properly on a device used in a hospital it could result in an arterial air embolism. Entering data incorrectly in some use scenarios could potentially result in an overdose. In both examples, the potential harm is critical and could be mitigated through better usability analysis which would feed into the design. The ideal outcome would be a design where it is impossible to connect the wrong tube, or where the product does not function if the tube is connected improperly. This is inherent safety by design which should always be the aim. THINGS TO CONSIDER DEVELOPING A PRODUCT WITH GOOD USABILITY One mindset that can lead to better outcomes is not being committed to or romantic about the current format or embodiment of the product. To design a product with the best usability possible, there must be an open mind and insights gained from the analysis of user needs must drive the characteristics of the product so that the outcome is not tied down by pre-existing beliefs. It may be that the overall format and architecture of the product changes significantly from its current state to deliver the best experience. A key part of good usability is to consider every stakeholder. By stakeholder, we don’t just mean those who are financially invested, but anyone who is affected by the product. Who uses it? Who cleans it? Who assembles it? Who maintains it? Who delivers it? Who sells it? This list is not exhaustive but allows us to start thinking about all the different groups of people who interact with the product. Then, we can dig down and build a user profile if there are common characteristics of the users. For example, this could be age, occupation, level of dexterity, level of experience with similar devices, etc. In addition to identifying the different user types, it’s important to identify and understand the use environments. As in, the different contexts in which the product will be used. When all stakeholders have been identified, it’s a good exercise to map out the experience journey for each and list out every interaction in as many different use environments as possible. Visibility of all interactions helps you see the bigger picture and is more likely to bring forward opportunities to simplify user interactions. This can improve usability but is difficult to do when you don’t have all the information mapped out. This process is pro-active and it’s incredibly important

because poor usability can often come about because the task was pushed back in the development until usability issues started to arise. This is too late. You end up fire-fighting and decisions start getting made quickly without the time for proper consideration and robust thinking. Another important aspect is to consider all human senses and their limitations. For example, detecting an audible alarm from a product may be affected by the age of the user, the possibility of hearing loss or just the noise level in the environment in which the product is being used. Another example could be memory. If there are too many steps to recall in a user task or if too much information must be remembered going from one screen to another in a digital app this could result in use errors. This is where usability feeds into the design and we can use multiple ways to improve the interactions and minimise use errors. For example, affordances that give cues to the user such as shape coding, resistance forces, size differentiation, universal symbols, orientation cues, etc. USABILITY AS PART OF DEVICE DEVELOPMENT A key part of usability is identifying all possible use errors. There are many exercises for this including observations, interviews, reading product reviews, reviewing known use errors, expert review, etc. An important step is a full task analysis. For example, if the product is a glucose meter and the task is placing blood on a strip, then examples of use errors could be applying too little blood onto the strip or applying the blood in the wrong location. Analysing each task like this then translates to features of the product. When as many use errors as possible have been identified to inform the design, only then would proper usability studies be carried out to reveal more use errors and opportunities for improvement. Formative studies would be done throughout the development to review the current prototype, uncover remaining issues and opportunities to further improve the design. Then, a summative study would be done to validate the product by testing the device in a controlled environment. These studies must be done in a particular way because part of the reason for doing them is to prove that you have gone through a rigorous process to mitigate the risks so that you can get certification from a regulatory authority. The IEC 62366 standard is a good reference point for anyone wanting to learn more about applying usability to medical devices.

A KEY PART OF GOOD USABILITY IS TO CONSIDER EVERY STAKEHOLDER. WHO USES IT? WHO CLEANS IT? WHO ASSEMBLES IT? WHO MAINTAINS IT? WHO DELIVERS IT? WHO SELLS IT?

WHEN AS MANY USE ERRORS AS POSSIBLE HAVE BEEN IDENTIFIED TO INFORM THE DESIGN, PROPER USABILITY STUDIES ARE CARRIED OUT TO REVEAL MORE USE ERRORS AND OPPORTUNITIES FOR IMPROVEMENT

In summary, usability is a key part of the process when developing medical devices. Not only is it a required component of your technical file but it brings benefits in the form of greater user experience and human interaction leading to all round better products.

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When usability is applied poorly during the product development process, the consequence is what we call ‘use errors’

WEBINARS ENGAGE YOUR AUDIENCE

Our webinars offer an insightful and professional means of reaching your target audience through thought leadership and individual engagement. Our fully managed and hosted webinar service allows you to: Showcase your expertise and industry knowledge Raise brand awareness Put a real face to your brand â&#x20AC;&#x201C; transform the way you engage with customers Run a cost effective alternative to meetings or seminars Gain a better understanding of your target audience Gain clearly defined and qualified leads Generate more sales MPN the essential information source for anyone involved in design, manufacture and supply of medical plastics devices. To find out more contact Amy Miller t: 01244 952 361 e: amy.miller@rapidnews.com www.medicalplasticsnews.com @MPN_Magazine

ADVANCING MEDICAL PLASTICS

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DIGITAL RETROFIT

TAKING A STEP BACK HOWARD FORRYAN, HARTING, EXPLAINS THE BENEFITS OF DIGITALLY RETROFITTING REAL-TIME PRODUCTION MONITORING TO PLASTIC INJECTION MOULDING MANUFACTURING LINES

ne of the key issues facing today’s manufacturing industry is how to improve the productivity of existing production lines for minimum cost outlay. A ‘digital retrofit’ of integrating additional intelligent devices and sensor technology into a wellestablished production line of plastics injection moulding machines can help to achieve these objectives. INTRODUCTION An important element of Industry 4.0 is the ability to apply digitalisation to the production environment by adding more intelligence into the existing process. Initially manufacturers have been wary of Industry 4.0, on the assumption that effective implementation would require expensive changes to production lines. However, through a digital retrofit, it is possible to smarten existing processes for minimal cost over a short period of time, resulting in a fast return on investment and immediate productivity gains. Digital retrofit provides four different ways to improve production processes, increase cost savings and extend the lifetime of different types of machinery: Legacy machine protocol conversion; condition monitoring / energy measurement; asset management; and predictive maintenance. LEGACY MACHINE PROTOCOL CONVERSION Central machine monitoring and process optimisation offer the best way to ensure that production lines and their associated constituent parts operate more effectively and economically. Many machines in wellestablished production lines, which may be between 15 and 30 years old,

can still perform their main functional tasks successfully. However, they do so much less eﬃciently than their modern-day counterparts. For example, they do not have the same level of computing power, enough memory capacity to record and store relevant data, or the ability to communicate with their modern equivalents. In many cases, these machines also use data formats and operating communication language protocols from the 1980s and 1990s, which are no longer used by today’s PLCs and industrial PCs. A prime example of a production environment that accommodates mixed protocol legacy machines would be a plastics injection moulding machine (PIMM) line. Such machines, when well maintained, can attain as much as a 30-year operational life. However, some of the older software protocol operating languages (eg. EUROMAP 15), cannot be directly connected to a factory MES (Manufacturing Execution System) without expensive annual custom software licensing charges. In a lot of factories these machines still require individual programming by an operator, which can be very time consuming for reasonably large installations and therefore potentially requiring input from multiple personnel. An MES keeps track of all manufacturing information in real time, receiving up-to-the-minute data from robots, machine monitors and employees. Although manufacturing execution systems used to operate as self-contained systems, they are increasingly being integrated with enterprise resource planning (ERP) software suites. The goal of a

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manufacturing execution system is to improve productivity whilst reducing cycle-time and the total time required to produce an order. Harting now offers a new solution to these challenges. MICA (Modular Industrial Computing Architecture) is an edge computing device in the form of a digitally retrofittable IP67 package with Linux-based opensource software. Its modular software and hardware architectural design platform permits the user to choose the programming language and development environment they are most familiar with. For the PIMM specific plastic moulding component manufacturing environment, Harting has developed the MICA Euromap 15 variant, which converts the legacy Euromap 15 TCP/IP machine operating communications protocol into OPC UA for example, via an intermediate JSON software format. CONDITION MONITORING Additional real-time condition monitoring of legacy machine key operating processes can help to reduce downtime and extend lifetime, achieving manufacturing productivity improvements. This can be accomplished by digitally retrofitting additional stand-alone MICA devices to store, analyse and process data from existing or extra retrofitted sensors. PREDICTIVE MAINTENANCE Critical operating parts of a plastic injection moulding machine which are subject to continuous wear and tear include the plasticising screw pump and associated check valves. As wear increases, this can result in a significant number of rejected parts and expensive financial losses. This situation can be resolved by monitoring the changes in the operating power curve characteristics of the screw pump and the pressure loading at the check valves.

THERMOFORMING

SPEAKING VOLUMES

PIETER VAN GOOL, NELIPAK HEALTHCARE PACKAGING, DISCUSSES INCORPORATING INNOVATIVE DESIGN CAPABILITIES WITH VOLUME STUDIES FOR HEALTHCARE PACKAGING OPTIMISATION

n the healthcare market, packaging is no longer merely a vessel to contain and transport a medical device from point A to point B. Packaging has become a critical and integral part of the surgical landscape. Optimised packaging can maintain a product’s eﬃcacy, prolong its shelf-life, and even play an active role in the operating room. On the other hand, packaging that does not perform as anticipated during final

validation can result in an OEM’s entire product failing to get to market, or malfunctioning packaging in the field can compromise patient safety. OEMs should look for healthcarespecific packaging thermoformers that can and should become true partners that work collaboratively with them to design optimised products fit-for-purpose to ensure the best performance, reduce waste,

and even improve the experience for the end-user. Partnering with an entirely medical-focused packaging provider that is well attuned to the needs of customers and immersed in the regulatory challenges that UNDERSTANDING THE VOLUME REQUIRED TO MOVE TRAY PARTS ALLOWS THE THERMOFORMER TO DECIDE ON THE OPTIMUM SHIPPERS, BAGS AND PALLETS REQUIRED TO SEND PRODUCT TO THE OEM

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THERMOFORMING

they face on a daily basis can make a significant difference in their ability to understand what solution is needed. This can ultimately mean the difference between success and failure for the entire project. Sterile barrier packaging for medical applications must be manufactured to exacting specifications under ISO-compliant cleanroom conditions from start to finish. But the efficacy of packaging for medical devices and pharmaceuticals is shaped long before the manufacturing process – it starts in the design phase. Choosing a packaging provider that has experienced teams of designers and engineers with the ability to leverage modern software and technology coupled with first-rate drawing skills during development can result in solutions that best meet the OEM’s needs for pack performance, functionality and product protection. It is important to leverage the most effective means to develop a thorough understanding of a how the complete packaging solution will perform. In order to achieve such understanding, it is critical to consider packaging distribution configuration. Minor changes in the length, width and height of a thermoformed product can have a major effect on logistic efficiency, both in terms of getting the thermoformed product to the OEM and the OEM maximising the pallet loads of their finished good for optimum sterilisation efficiency. Design features can influence the logistic volume when shipping empty nested thermoformed trays and storage prior to loading product on the line. For example, consider de-nesting features and snap features that secure the content into thermoformed trays. Making this visible with a volume study gives OEMs a better understanding of the impact on the process and facilitates the decision-making process of the final design. Volume efficiency is increasingly important for OEMs who are challenged with balancing warehouse space with manufacturing footprint to maximise revenue. Giving the designer an overview of the holistic packaging requirements brings them closer to the project and allows them to add more expertise. Downstream thinking beyond the OEM to the OR is extremely valuable when it comes to differentiating oneself in the marketplace. A clear understanding of the volume required to move tray parts allows the thermoformer to make informed decisions on the optimum shippers,

bags and pallets required to send product to the OEM. Through careful selection of the above items, reduction of the number of components needed to ship parts can be achieved, eliminating cost and material waste of shipper components. Volume studies provide a clear understanding of the loading factor for product shipping from the thermoformer to the OEM, leading to potential reduction in shipping loads. Using pallet load applications, Nelipak designers recently evaluated max height of pallet loading and different loading configurations to achieve an average of 20% savings in shipping volume. The net effect realised a reduction from six to five standard 53ft container trucks, along with the associated decrease in shipping unit costs and carbon footprint. Another key feature of using volume studies is the opportunity to look at downstream operations where increased design eﬃciency can impact post-packing operations. Understanding the impact of the design on the finished pack creates greater awareness to maximize load eﬃciency off the dock of the OEM’s facility, reducing transportation costs. More importantly, it allows both the thermoformer and OEM to clearly understand the impact on the time costly and time-consuming sterilisation process (autoclave steam, ethylene oxide, gamma ray, electron beam) where the goal is to maximise the number of units through the process. Again, this provides opportunity for cost savings while meeting company sustainability goals for manufacturing carbon footprint. Taking the process a step further, volume studies provide both the OEM and thermoformer with information relative to the potential impact of finished product on the hospital shelf and, increasingly, the amount of material nurses need to place in the correct recycle stream as hospitals look to become more sustainable. The path to market can also go much more smoothly if OEMs and their medical device packaging provider also collaborate to develop custom specifications, including design failure mode effects analysis (DFMEA). This helps ensure that all required specs are critical-to-quality and are accurately related to the product’s intended use and function, eliminating the complexities of making the packaging meet non-relevant and sometimes unrealistic generic specs in order to successfully pass the validation process.

DESIGN FEATURES CAN INFLUENCE THE LOGISTIC VOLUME WHEN SHIPPING EMPTY NESTED THERMOFORMED TRAYS AND STORAGE PRIOR TO LOADING PRODUCT ON THE LINE.

Listing generic critical-to-quality requirements that are not linked to the functionally or intended use of a packaging product can lead to ineffective criteria being used to gauge the effectiveness of medical device packaging. This can result in considerable delays to market; rectifying the problem ultimately costs the OEM unnecessary time, money and resources. Design for manufacturing is another important consideration for the thermoformer in the design process; having a package that ticks all the boxes for the customer is of little use if the product is difficult to manufacture. In conclusion, by working together as true partners, thermoformers and OEMs can collaborate to produce optimised, fit-for-purpose packaging while also reducing costs and minimizing manufacturing and shipping footprints. This is particularly critical in today’s stringent healthcare environments. By involving seasoned designers early in the development process that conduct effective volume studies, determine the most applicable custom specifications, and keep manufacturing needs in mind from start to finish, OEMs can achieve the best results from their medical packaging.

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MEDTEC CHINA

MEDTEC CHINA REACHES AN INTERNATIONAL MARKET M

edtec China 2018 will be launching a regulatory zone to address the international medical device industry in China. The Chinese government is encouraging the internationalisation of local innovative medical device production to explore global opportunities. Medtec China, dedicated to medical device design and manufacturing in China, will be held 26-28 September in Shanghai. It aims to continue contributing to the acceleration of this development.

This yearâ&#x20AC;&#x2122;s show will launch a new exhibiting zone called Regulatory Street, which is supported by Shanghai Pudong Medical Device Trade Association, consultant companies and keynote speakers from North America, Europe and China, with regulatory updates for China, the US and the EU provided in this zone. Meanwhile, the China Chamber of Commerce of Medicines & Health Products Importers & Exporters (CCCMHPIE) is also joining Medtec China 2018 to hold a seminar to discuss how to accelerate the

Shanghai will be home to Medtec China this year from 26-28 September. This yearâ&#x20AC;&#x2122;s event has a strong regulatory theme to reflect the growing global device market in China

internationalisation of the medical device industry in China and what are the challenges and opportunities. REGULATORY STREET HELPS LOCAL BRAND GO GLOBAL With the rapid development of Chinese medical device manufacturing, more competitive products are being exported to the US, EU and other regions around the world. Therefore, local regulation compliance and certification is important. This regulatory zone was

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MEDTEC CHINA launched for this reason. Shanghai Pudong Medical Device Trade Association has offered its full support. Exhibitors in Regulatory Street provide comprehensive regulatory consultant services including accessing markets in North America, Europe, Japan and Canada. For example, Dr. Knoell Consult offers client-specific strategic advice for the global registration of medical devices. It assists companies in designing quality management systems and the associated support for preparation and up-keeping of technical documentations. As a leader in the medical device industry for a many years, WuXi AppTec provide testing plans which can be customised at any stage of the product development life cycle. Meanwhile, Shanghai Huaxia Investment Management Co, specialises in enterprise registration, financial agents, trademarks, personnel and other one-stop business service SEMINARS FOR HIGH-END MEDICAL DEVICE PRODUCTION The five-year plan focuses on the development of an advanced domestic medical device industry. To speed up the internationalisation of high-end medical device production,

the China Chamber of Commerce for Import & Export of Medicines & Health Products (CCCMHPIE) will be holding a seminar at Medtec China 2018 to share information about marketing in countries along the Belt and Road and how to solve the challenges of this program. Mindray, Neusoft, Shinva, UnitedImaging, Sonoscape, WEGO, Yuwell, Fosun and Anke who are members of CCCMHPIE may join this meeting at Medtec China 2018. DEBUTING COMPANIES More than 50 companies are going to debut at Medtec China 2018 and in all, 400 suppliers will congregate at this annual event on 28 September in Shanghai to showcase exhibits of medical raw materials, components, tubing and extrusion, manufacturing equipment, contract manufacturing services, and regulatory consultant services for more than 10,000 decision makers, purchasing staff, R&D engineers, product engineers and quality inspectors from medical device manufacturers. Debuting exhibiting companies include Wynca, a global supplier of silicon-based new material products; Shanghai BAODIE manufacturer specialising in high speed single/

multi-layer medical tube/pipe extrusion lines Arone, a precision mechanical manufacturer including medical devices, and electrical/ electronic parts. Era-contact (Suzhou) Co is from Germany and boasts proficiency at designing and assembling complex electrical systems. It also possesses high-level technology, such as resistance welding, hot melt injection, and glue packaging. WWW.MEDTECCHINA.COM.

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Five exciting Medtronic developments

Medtronic’s HVAD System is a less invasive approach for advanced heart failure. This left ventricular assist device (LVAD) is the smallest commercially available LVAD and the only device approved in the US for implant via thoracotomy

Medtronic's Infuse Bone Graft for new spine surgery indications has received FDA approval

The company is staking a big claim on the eﬃcacy of its MiniMed 670G insulin pump system, with a new programme that offers a performance guarantee to payers and employers using the device.

FDA has cleared Medtronic’s Riptide Aspiration System device that restores blood ﬂow during stroke acute ischemic stroke (AIS).

Two patient trials have linked Medtronic’s AdaptivCRT algorithm to a reduction in atrial fibrillation (AF) episodes, as well as higher levels of patient activity.

08:2018 SEAL OF APPROVAL: GLUCOSE MONITORING GETS THUMBS UP FROM FDA

he Eversense Continuous Glucose Monitoring (CGM) system has been approved by the FDA. It is said to be the first FDA-approved CGM system to include a fully implantable sensor to detect glucose and can be worn for up to 90 days. The system uses a small

sensor that is implanted just under the skin during an outpatient procedure. After it is implanted, the sensor regularly measures glucose levels in adults with diabetes for up to 90 days. The implanted sensor uses light-based technology to measure glucose levels and send information to a mobile app to alert users if their glucose levels are too high or too low. The sensor is coated with a ﬂuorescent chemical which produces a small amount of light that is measured by the sensor when exposed to blood sugar. Measurements are sent to a user’s mobile every five minutes through the compatible app.

WIRELESS PACEMAKERS MEAN LESS COMPLICATIONS, SAYS STUDY

eadless pacemakers have been found to reduce the number of shortterm and midterm complications compared with conventional device designs, a new study has shown. Research from the Cleveland Clinic shows that patients are less likely to experience complications if they have pacemakers that don’t use wires to connect the device to the heart.

most common source of complications for patients. Leadless pacemakers, which don’t need wires, are small, self-contained devices which are placed directly into the heart using a catheter that is carried from the leg to the heart via the thigh’s femoral vein. Cleveland Clinic’s study compared short and mid-term complications between 718 patients

receiving the Nanostim leadless pacemakers and 1,436 patients with conventional pacemakers. The study found that at one month and up to 18 months, patients receiving the leadless pacemaker had fewer complications overall. The leadless pacemakers were found to eliminate lead and pocket complications, including infections.

Conventional pacemaker models are connected to the heart via a wire that stretches from the shoulder vein to the heart. According to previous research, these wires are the

Check out...

The special episode of the MedTalk podcast! In this special episode of the MedTalk Podcast, Reece Armstrong chats to a key inﬂuencer in the UK digital health market. Iain Hennessey, clinical

director of Iinovation at Alder Hey Children's hospital about how augmented reality and other digital technologies can boost services within the NHS – a great listen for

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MPN manufacturers looking to see where digital opportunities exist in the future. Soundcloud.com/ medtalkpodcast

Nelipak® provides total package, custom thermoformed solutions, value engineered to deliver ergonomic packaging ﬁt-for-purpose reducing the cost of ownership and waste throughout the product lifecycle. Nelipak develops award-winning packaging solutions using in-house design innovation, development, prototyping, tooling and production to ISO:13485 certiﬁed standards.

SEALING MACHINES

HANDLING TRAYS

A range of custom-built medical tray and blister heat sealing machines

For high-speed production and automated pick-and place assembly and transit

MEDICAL DEVICE AND PHARMACEUTICAL PACKAGING Full-service solutions that provide superior quality and protection