MPN EU Issue 49 by MPN Magazine

EUROPEAN EDITION

MEDICALâ&#x20AC;&#x2C6;PLASTICS news +

SMART HOSPITALS DEVELOPING WEARABLE MEDICAL DEVICES HOW TO PREPARE FOR OVERSEAS INSPECTIONS

Integrating intelligent assistance systems into validation strategies for medical products ISSUE 49

July-Aug 2019

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CONTENTS July-Aug 2019, Issue 49

Regulars

Features

5 Comment Laura Hughes asks: Are we ready for smart hospitals?

21 Turn up the heat David Stirling, Zotefoams talks about the advantages thermoforming could offer medical device manufacturers

15 Are you ready for it? Simon Bastarache, Optel Group, explains why he believes the medical device industry is ready for serialisation

29 How to develop wearable medical devices Tom McLean, West Pharmaceutical Services highlights the challenges associated with developing wearable medical devices

37 A reality check Web content editor Ian Bolland writes about his trip to Vision Engineeringâ&#x20AC;&#x2122;s headquarters

6 News focus A look at what the future holds for the global consumer electronics market 8 Digital spy 16 Cover story Johannes RazenbĂśck, Engel Austria explains how intelligent assistance systems can be integrated into validation strategies for medical products 42 08:2019

32 Robots rise to the plastic processing challenge Nigel Flowers, Sumitomo (SHI) Demag explains the benefits robots can offer within injection moulding

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EDITOR’S

group editor | dave gray head of content | lu rahman assistant editor | ian bolland advertising | sarah livingston sarah.livingston@rapidnews.com head of media sales life sciences & plastics | lisa montgomery head of studio & production | sam hamlyn graphic designer | matt clarke junior designer | ellie gaskell publisher | duncan wood Medical Plastics News Europe Print Subscription – Qualifying Criteria UK & Europe – Free US/Canada – £249 ROW – £249 Medical Plastics News NA Print Subscription – Qualifying Criteria US/Canada – Free UK & Europe – £249 ROW – £249 FREE on iOS and Android devices Subscription enquiries to subscriptions@rapidnews.com Medical Plastics News is published by: Rapid Life Sciences Ltd, Carlton House, Sandpiper Way, Chester Business Park, Chester, CH4 9QE T: +44(0)1244 680222 F: +44(0)1244 671074 © 2019 Rapid Life Sciences Ltd While every attempt has been made to ensure that the information contained within this publication is accurate the publisher accepts no liability for information published in error, or for views expressed. All rights for Medical Plastics News are reserved. Reproduction in whole or in part without prior written permission from the publisher is strictly prohibited.

BPA Worldwide Membership ISSN No:

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

Smart hospitals: Are we ready?

s medical device company Medtronic hits the headlines for all of the wrong reasons, the security of medical devices is again put in to question. The company withdrew 11 versions of its MiniMed insulin pumps following the revelation that a hacker could change the settings of a pump to over- or underdeliver insulin to a patient through a wireless connection. These potential modifications could result in serious complications such as diabetic ketoacidosis, and high or low blood sugar levels for the patient. As we look towards a paperless and thus, more digital future within healthcare, setbacks like this raise big questions about how ready we are for the implementation of more digital devices within the sector. Mobile applications such as Forward – a new mobile messaging app for doctors and nurses - and Silo – a similar application - aim to replace outdated tech like pagers and fax machines, still widely used in clinical settings. Forward claims to offer a user friendly, secure messaging service, while Silo states it is 100% confidential. However, what was really wrong with using a pager? The advantages are numerous, but crucially they don’t drop out if the WiFi goes on the blink. New tech though is always good – but like any capital investment, it comes with risk.

Adopting tech also costs a lot of money – the training, the time and work needed to update documents such as standard operating procedures, and the cost of the devices themselves, just to name a few of the things involved. The implementation of new processes also causes issues, which are often not fully known or realised until the technology is integrated within a workplace. Other futuristic devices being adopted at pace – things like surgical robots and 3D printers – also find themselves part of the connected healthcare ecosystem. Data file transfers to a 3D printer, for example, could put that particularly expensive piece of equipment at risk of unintended harm. While patients wouldn’t necessarily be affected in this case, a virus or piece of malware intended for the wider system could result in a bricked 3D printer - a huge financial hit and disruptive in terms of downtime. It doesn’t harm the patient, but indirectly, it does harm the patient.

As we look towards a paperless and thus, more digital future within healthcare, setbacks like this raise big questions about how ready we are for the implementation of more digital devices within the sector.

Smart hospitals are becoming a reality. But at a time when the sector is already on the receiving end of some bad publicity (think The Implant Files, the mesh scandal, and The Bleeding Edge), Medtronic’s latest recall is something the industry could’ve done without. Instead of the scaremongering headlines reported in the national press, a more reasoned, ‘thank God they caught it before it happened’ approach, would’ve been more helpful.

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NEWS FOCUS

What does the future hold for the global consumer electronics market? FROST & SULLIVAN RECENTLY REPORTED THE RESULTS OF THEIR ANALYSIS TITLED, ‘PLASTICS AND POLYMERS IN THE GLOBAL CONSUMER ELECTRONICS MARKET, FORECAST TO 2025’ WHICH AIMS TO PRESENT TOPICS SUCH AS GROWTH TRENDS AND REGULATORY ASPECTS ACROSS APPLICATIONS INCLUDING WEARABLES, AND COMPUTING DEVICES.

his report is part of Frost & Sullivan’s chemicals and materials in infrastructure and mobility research and analysis. The council is responsible for firstly identifying a continuous flow of growth opportunities, and then ensuring their success. Key materials were also looked at in the report including polycarbonate (PC) and acrylonitrile butadiene styrene (ABS) blends (PC/ABS), polycarbonate (PC), polystyrene (PS), ABS, polymethyl methacrylate (PMMA), and thermoplastic elastomers (TPEs). Within the report growth opportunities were identified in the plastics and polymer sector of consumer electronics applications which could potentially transform the industry going forward. The innovative use of application-specific grades and the low costs associated with internet connectivity offer exciting opportunities for this field.

The growing emphasis on recycling will also advance the use of environmental design principles across consumer electronic devices. Gautam Rashingkar, research analyst, chemicals & materials in infrastructure & mobility commented: “Global consumer electronics manufacturers are increasingly partnering with material suppliers to develop greener, sustainable materials and bio-based alternatives. There is also a renewed focus on the life cycle of materials in order to minimise the carbon footprint and better manage end-of-life concerns associated with the end product.” The increasing number of novel wearables and smart home devices will aim to create growth opportunities. Rashingkar adds: “Furthermore, dwindling sales of conventional desktop PCs, which account for a significant share of market volume, and increased adoption of non-plastic alternatives such as glass and aluminium, among other materials for certain high-end applications, are key factors that are expected to impede market growth.”

It is thought that companies could maximise their future success by simply adhering to regulatory agencies’ stringent regulations and standards, and through the development of different products which offer unique properties and functions. Other ways to ensure growth could be to collaborate with value-chain partners to ensure a specific grade is developed, or alternatively to collaborate with original equipment manufacturers. Additionally, in countries such as Vietnam, India and Mexico there are significant electronics manufacturing investments anticipated, and therefore an idea to ensure growth could be to strengthen any electronics-specific material business strategies and portfolios within these areas. The Frost & Sullivan report also says that partnerships which develop and promote the adoption of greener, sustainable materials and bio-based alternatives will drive strong growth prospects.

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DIGITAL SPY

DIGITAL

DEVICE UPDATE

www.ascom.com

spy

Smart phone claims to be a game-changer for manufacturing staff

DEVICE UPDATE www.check-cap.com

POSITIVE RESULTS FOR PREP-FREE COLON CANCER SCREENING SYSTEM

-Scan system, CheckCap’s ingestible X-ray scanning capsule for prep-free colon cancer screening has announced positive results from its post-CE approval study. The C-Scan system has previously received regulatory approvals in Europe and Israel, and a pilot study is being conducted in the United States with initial results anticipated this year. Screening for precancerous polyps is thought to be the most direct method for prevention, and so the system works by detecting precancerous polyps. Nadir Arber, principal investigator of the study commented: “There is a great unmet need for a patient-friendly and preparation-free screening option that can detect polyps in the colon before they become cancerous.”

Patients are able to swallow the capsule alongside a tablespoon of radiopaque contrast solution. The capsule then moves through the gastrointestinal tract by natural motility, allowing the patient to continue their day-to-day life as normal, and without the need for fasting or bowel preparation. The capsule is able to measure the circumferential dimensions of the inner surfaces and capture this information. Afterwards, the capsule is naturally excreted from the patient’s body. Arber concluded: “I am encouraged by C-Scan’s potential to reduce global incidence of colorectal cancer and I look forward to seeing this ‘swallow and forget’ product available in clinics worldwide.”

orkflow technology innovator Ascom has released a smart phone specifically for manufacturing staff named, ‘Myco 3’. Myco 3 is a Google certified Android OS handset, which has a familiar feel and operability to smart phones on the market. The device also has key relevant features such as resistance to both dropping and chemicals, and the ability to be loaded with applications and features to provide support for factory floor workers. The device also has a 1D/2D barcode scanner, and a handy carry clip . Other features of the device include the integration of staff rotas, delivery schedules, and the feedback of data into administrative and analytical systems. Additionally, Myco 3 uses a swappable battery which prevents the need to power down or exit applications. Just

AGENCY UPDATE

www.who.int

WHO launches five year plan to deliver quality-assured medical products to everyone

n 2019, the health of people within lower- and middle-income countries continues to be put at risk every single day. As a result, the World Health Organisation (WHO) has launched a five year plan titled, ‘delivering quality-assured medical products for all 2019-2023.’ The plan outlines four main objectives which include aims such as decreasing timelines for product registration in order to enable patients to receive products sooner. Another objective focuses on equipping regulators with how to deal with emergencies and improving crisis communication. WHO will also continue to strengthen and expand its prequalification, as well as investing time in the organisation’s regulatory support activities.

like a normal smart phone. Myco 3 allows processes such as twoway text, image, voice and video communication. Paul Lawrence, managing director, Ascom UK said: “Myco 3 has the potential to be a gamechanger in manufacturing, so we look forward to working with operators to help them unlock new levels of performance.”

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For the first time WHO will also be aligning it’s goals and activities with global partners, such as the Bill and Melinda Gates Foundation to ensure the safe and quality-assured supply of medicines, vaccines, medical devices and other health products to those who need them.

DIGITAL SPY

TECHNOLOGY UPDATE

www.umich.edu

New technology developed to detect atrial fibrillation after strokes

ealthcare professionals often look for signs of atrial fibrillation in patients who have just suffered from a stroke. Atrial fibrillation refers to an irregular and often abnormally fast heart rate, and although it can be managed with medication, the problem really lies in detecting the indication initially. Devin Brown, professor of neurology and stroke neurologist at Michigan Medicine believes that, “more accurate identification of atrial fibrillation should translate into more strokes prevented.” New technology called electrocardiomatrix has been developed which works by converting two-dimensional signals from the electrocardiogram in to a threedimensional heatmap. This allows rapid

inspection of all the collected heartbeats, and thus hopefully a fast, accurate detection of cardiac arrhythmias. Jimo Borjigin, co-inventor of the technology and professor at Michigan Medicine stated: “We validated the use of our technology in a clinical setting, finding the electrocardiomatrix was an accurate method to determine whether a stroke survivor had atrial fibrillation.” Results which have recently been published in the scientific journal Stroke for the electrocardiomatrix include the technology being accurately able to identify atrial fibrillation in 260 out of 265 stroke patients. Borjigin concludes: “I believe that sooner or later, electrocardiomatrix will be used in clinical pract

talking

POINT

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NEW MEDICAL DEVICE COULD IMPROVE THROMBOSIS STATISTICS Paul Westerman set up RBR Active with his wife following his own personal experiences. Westerman suffered a massive pulmonary embolism, and as a result developed deep vein thrombosis (DVT). The company’s aim is to raise awareness of the main signs and symptoms of thrombosis, including through devices such as RBR Legflow. WHAT IS THE DEVICE? RBR Legflow is a medical device which is designed to increase blood flow to the lower limbs, and as a result reduce the risk of developing DVT.

MEDTECH UPDATE

www.inventia.life

Multiple awards for the world’s first 3D bioprinting platform for cell biology

ydney medtech company, Inventia Life Sciences, 3D bioprinter technology has been awarded both the Good Design Award of the Year and the Best in Class award in Australia’s Good Design Awards 2019. Since 2013, the company set out with the mission of creating a bioprinter specifically for medical research. The developed technology is able to create

realistic replicas of tumours in order to test potential cancer treatments and is the first high-throughput 3D bioprinting platform designed for cell biology in the world. Rastrum, the name of the company’s bioprinter, claims to be easy to operate with a simple - plug, play, print approach, and also extremely efficient – being able to manage hundreds of experiments per day. The company also state that the bioprinter provides unprecedented reproducibility. Co-founder Aidan O’Mahony comments: “There are a lot of bioprinters out there that are very aimed towards tissue engineering. We took a very strong focus on building something for biologists, and we were very clear about that from the beginning.”

WHY DO WE NEED THIS DEVICE? One in four deaths across the world are related to thrombosis. Thrombosis is the formation of a blood clot inside a blood vessel, which as a result obstructs the flow of blood through the circulatory system. WHEN WOULD THE DEVICE BE USED? RBR Legflow is suitable for extended periods of inactivity which cannot be avoided. This includes things such as airplane journeys, being hospitalised or working in an office job. IS THERE ANY EVIDENCE? Independent clinical trials have taken place for the device, and it has been proven to increase blood flow to the lower limbs by 11 fold, even when the person is seated. DOES THE PRODUCT CONTAIN ANY ANTIMICROBIAL TECHNOLOGY? SteriTouch’s antimicrobial technology aims to prevent the development of bacteria and microbes on the surface. It also aims to reduce odours. The addition of antimicrobial technology to the device helps to ensure it conforms with clinical regulations. 9

CYBERSECURITY

HAVE WE LEARNED

ANYTHING

FROM MEDTECH

SECURITY BREACHES?

MEDICAL PLASTICS NEWS EDITOR LAURA HUGHES ASKS WHY MEDICAL DEVICE CYBERSECURITY STILL CONTINUES TO BE A HEADACHE FOR MEDTECH DESIGNERS, DESPITE YEARS OF SCANDALS.

CYBERSECURITY

s we move in to progressively more digital times, we see connected technology taking over more and more of our everyday activities – and of course, that includes our health management. But some in the medical device and tech industries believe that healthcare providers and manufacturers are not working together effectively enough to mitigate the risk. Carolyn Crandall, chief deception officer at Attvio Networks, a specialist in emerging cybersecurity technology, believes that stakeholders on both sides could be more proactive when it comes to the cybersecurity of medical devices. Crandall told Medical Plastics News that the topic is a source of friction between device manufacturers and healthcare providers. According to Crandall: “If a business buys the equipment, they know that they have to manage their security. They’ve accepted that they’ve got to build defences and a strategy to try and protect their networks. “[However] this is an investment that healthcare providers have not always sufficiently made.” She believes that questions remain unanswered regarding who owns the devices, and who is responsible for ensuring the systems are secure. In an article for MPN online, explaining the FDA’s stance on the issue of cybersecurity, Anita Finnegan, founder and leader of Nova Leah, a firm that develops risk assessment software for medtech, said there are ways to combat the continuously changing nature of the threat:

“Manufacturers can do this by building-in security controls during the product design phase and by continuously monitoring devices to address on-going cybersecurity concerns, […] The onus is now very much on medical device manufacturers to adopt a proactive and vigilant approach to evolving cybersecurity threats and vulnerabilities when designing, developing and maintaining the security of their medical devices. Nova Leah’s system, for example, aims to support medical device manufacturers by ensuring the design, verification and certification of a medical device meet industry security standards. Despite the positive conversations taking place, cybersecurity continues to be one the biggest challenges for connected medtech. Most recently the healthcare sector made the headlines, and once again it was for all the wrong reasons, following a data breach for Quest Diagnostics, an American clinical laboratory. In the wake of the personal information of millions of patients being exposed, Dr. Teow-Hin Ngair, CEO of SecureAge, a government and enterprise data security and encryption provider commented: “This is not the first time the healthcare industry has seen a breach in client information. One of the fundamental issues is that medical agencies, providers and hospitals aren’t making cybersecurity enough of a priority in general. “This could stem from the fact that lost patient records do not really impact their business directly – and they don’t lose any money directly resulting from patient record breaches. Unless more regulations are put in place, this will continue to be a recurring issue.” The Quest Diagnostics story actually emerged from a vulnerability in the lab’s billing system, rather than from a medical device. However, it’s the latest in a string of scandals that demonstrate how the connected care ecosystem still remains dangerously open to attack. Stories like this need to be seen as lessons learned - drivers for change in medical device design considerations. For example, in a guest contribution for our sister title Med-Tech Innovation News, Stacie Hoffmann from the UK’s IoT Security Foundation made the point that even since Medtronic’s high profile case involving an implantable defibrillator which was found to be vulnerable to malware attacks, many medical devices have still not adopted basic security practices such as hard-coded passwords. Hoffmann believes that there are 17 key considerations that must be factored in to medical device design. Included among these are end-to-end encrypted data communications, as well as the avoidance of unsupported operating system versions in boundaryless architecture. So, what does this all mean for manufacturers of medical devices? With confusion remaining around who is actually responsible for managing cyber threats, each person and organisation involved within the supply chain needs to take responsibility for the product when they are involved. The good news is, more and more experts on both sides (industry and clinical) are starting to release practical guidance to support in the design process.

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SERIALISATION

ARE YOU READY FOR IT? SIMON BASTARACHE, GLOBAL HEAD OF STRATEGY - MEDICAL DEVICES FOR OPTEL GROUP, A GLOBAL PROVIDER OF VISION INSPECTION AND TRACEABILITY SYSTEMS, EXPLAINS WHY HE BELIEVES THE MEDICAL DEVICE INDUSTRY IS READY FOR SERIALISATION.

n November 2018, the International Consortium of Investigative Journalists (ICIJ) released the Implant Files, the culmination of a yearlong investigation into how governments around the world handled the approval and monitoring of medical devices. The ICIJ report prompted governments to begin drafting new regulations, while industry players began contemplating better ways to detect defects, react quickly to recalls and protect their brands. Serialisation provides a promising solution because it enables traceability - the ability to know exactly where along the supply chain an individual device or component is at any given time. On average, one company per year sees a 10 percent drop in share price after a single, major quality event such as a recall, and the risk of long-term reputational damage is real1. Serialisation can play an important role in mitigating these risks. To date, mandatory unique device identifiers (UDIs) have been the focus of regulatory reform to address recalls and other issues. While UDIs are an excellent starting point, serialisation is the crucial next step that will allow the industry to better manage the flow of product through the supply chain, guard against counterfeiting, and reassure patients that the medical devices they use have been properly tracked, traced and monitored. In order to achieve traceability, the industry needs to adopt systems that apply and manage serialised data and ensure connectivity with various databases. These systems need to collect and leverage granular data to gain visibility throughout the supply chain. This data could then be leveraged to facilitate inventory management. This would allow monitoring of product usage at the patient level, which could lead to improved product development strategies, and help the industry better manage recalls and inventories whilst complying with emerging government regulations. The entire supply chain becomes connected when all stakeholders become willing to share relevant data, from the manufacturers all the way up to the patient.

Serialisation could benefit the manufacturers of plastics in medical and drug delivery devices in many ways. For example, serialised drugdelivery devices can integrate enduser programs in order to provide information about what medication is used the most, what dosage works best for the patient and what types of usage affect the product’s life cycle. Importantly, serialisation can also enable the industry to respond promptly to defects and recalls. Is the medical device industry ready for serialisation? Absolutely. Supply chain traceability technologies such as serialisation can and must play a key role in overseeing, improving and assuring the quality of medical devices, just as it does for pharmaceutical products. By tracking individual devices throughout their life cycle, traceability makes it possible for all stakeholders at every step along the supply chain - from the manufacturer to the healthcare provider to the patient, in order to know everything there is to know, about any given device, anywhere in the world. Many manufacturers are expressing interest in ‘connecting’ their devices and taking advantage of artificial intelligence (AI) and other available technologies. That being said, both the medical device industry and its regulatory bodies have yet to fully embrace serialisation, perhaps because the conversation is still in the exploratory stage. We’ve also learned from the pharmaceutical industry that adopting or reinforcing legislation to protect the patient and gain better control of the distribution channel is a long process that can take a decade or more. Therefore, what is clear today is that in this era of connectivity, data management and AI, the first adopters of serialisation will have a definite advantage over their competitors. REFERENCE: www.mckinsey.com

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COVER STORY

sing assistance systems with injection moulding opens up new possibilities for higher process accuracy and product quality. Such intelligent software solutions adapt the process parameters to the current conditions cycle by cycle. An example is iQ weight control by Engel, which automatically compensates in real time for external influences such as fluctuations in the raw material. The challenge for medical technology, however, is to integrate this dynamic process control into the validation process. Different approaches to the validation process were examined and a procedure derived which makes it possible to validate processes with iQ weight control in compliance with both EN-ISO and Food and Drug Administration (FDA). For medical products, the notified bodies in Europe and the United States of America require detailed documentation during the entire product development, process planning and manufacturing process. The requirements for this can be found in the European standard “EN ISO 13485:2016 – Quality management systems for medical devices” and in the American FDA regulation “21 CFR Part 820 – Quality systems regulations”. Both regulations stipulate that a company must validate critical production processes whose results cannot be verified by subsequent monitoring or measurement. This includes injection moulding processes in mass production, where 100-percent inline inspection is usually not advisable. However, the implementation of the validation is not specified either in the American regulation or in the European standard. Only the tasks to be performed by the manufacturer are recorded in various directives and guidelines. It is common practice to validate injection moulding processes on the basis of machine parameters. However, changing ambient conditions that influence the viscosity of the melt can lead to rejects that are not taken into account. Many processors are asking themselves how the new dynamic process control can be integrated into a validation strategy for the manufacture of medical technology products in compliance with current laws and standards.

JOHANNES RAZENBÖCK, PROJECT MANAGER - MEDICAL AND CHRISTOPH LHOTA, VICE PRESIDENT OF THE MEDICAL BUSINESS UNIT, ENGEL AUSTRIA EXPLAIN HOW INTELLIGENT ASSISTANCE SYSTEMS CAN BE INTEGRATED INTO VALIDATION STRATEGIES FOR MEDICAL PRODUCTS.

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COVER STORY

The key to this lies in the definition of process windows and the validation of these process areas. Engel iQ weight control offers the possibility of limiting the scope of readjustment. Based on experience or test results, limit values are determined for the readjustable parameters switchover point, injection profile and holding pressure, respectively, and are stored in the control system. This ensures that the process parameters do not fall outside of the validated range despite dynamic process control, and that the process complies with the regulatory requirements. ADAPTING THE VALIDATION STRATEGY TO THE PRODUCT First, the product requirements must be defined on the basis of measurable acceptance criteria. This is usually done on the basis of the risk analysis and is described in a Validation Master Plan (VMP). The VMP contains the validation strategy of a company and should clearly define the key elements of the qualification and validation program. To this end, the VMP must describe very specifically which validation principles are implemented in the company and how, and which persons assume responsibility at which level and in what form. This task should be performed by a group of experts, known as the task force, consisting of product and process engineers from the plastics processor. Every product has Critical Quality Attributes (CQA), which in injection moulding production can be things such as a linear measure or the surface quality. In the validation, it is necessary to find the corresponding Critical Process Parameters (CPP) that affect the CQA. The experts define these critical injection moulding parameters on the basis of data sheets and figures based on experience with comparable injection moulding processes. In the case of critical components such as functional elements of a drug delivery system, the statistical Design of Experiments (DoE) is used to determine the process limits. For the majority of applications, simplified planning based on empirical values is sufficient to define a permitted parameter window. If the CQA are within the accepted limits, parameter ranges in which the process can be adapted can be set. In addition, the stability of the process is examined in this phase. CONTROLLING PROCESS PARAMETERS IN REAL-TIME The iQ weight control assistance system is real-time control software that adjusts process parameters during the running cycle to ensure consistently high component quality. The software compares the injection pressure above the screw position with a reference pressure curve and identifies deviations in injection volume and viscosity. The automatic adjustment of the switchover point, injection profile and holding pressure compensates for target deviations shot by shot. Consequently, the switchover point and holding pressure level must be defined as CPP in the validation strategy. The limit values for the switchover point and holding pressure determined in the DoE are adopted in the CC300 controller of the Engel injection moulding machine as the limit value for process control with the aid of iQ weight control. If it is necessary to regulate the parameters outside of the validated limits in order to achieve the specified product quality, a corresponding procedure can be defined in the control system. For example, the respective shot can be declared as scrap or the production

IN MEDICAL TECHNOLOGY MANUFACTURING NEW APPROACHES ARE REQUIRED IN ORDER TO INTEGRATE THE RULES AND REGULATIONS ACCEPTED BY THE AUDITORS. INTELLIGENT ASSISTANCE SYSTEMS HELP TO MAKE PRODUCTION MORE PREDICTABLE, RELIABLE AND STABLE. ENGEL ÂŠ

process can be stopped if the limit values are permanently exceeded. Simplified rules are also possible. For example, by keeping the switchover point constant and adjusting the holding pressure, or vice versa, keeping the holding pressure constant and adjusting the switchover point. The validation strategy described makes it possible to use intelligent assistance systems in medical technology as well, in order to further increase process consistency and process reliability. This allows quality fluctuations of the raw material and changes in ambient conditions to be dynamically and reliably compensated for in the validated process. Using simple logic, the innovative algorithms employed by intelligent assistance systems can be integrated into the validation strategy.

IQ WEIGHT CONTROL

roducing moulded parts of a consistently high quality shot by shot is the aim of every processor. However, this will not be achieved by simply using a precise injection moulding machine. Even minor changes in ambient conditions or in raw materials and wear have an effect and may require the readjustment of parameters. The iQ weight control software makes it possible to automatically recognise deviations and compensate for them in the same shot. In this way, process consistency and reproducibility are increased and rejects are drastically reduced. The result is higher productivity with consistently high product quality. Intelligent assistance is a key feature of the smart factory as described by the objective of industry 4.0. Engel was quick to focus on the trend towards

WWW.MEDICALPLASTICSNEWS.COM

digitalisation and networking of production processes, and offers a range of mature and repeatedly proven products for this purpose. The modularity of Engelâ&#x20AC;&#x2122;s inject 4.0 approach makes it especially easy for plastics processors to utilise the new possibilities. Even individual solutions like iQ weight control provide a huge benefit.

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OVERSEAS INSPECTIONS

FAIL TO PREPARE, PREPARE TO FAIL

MPN EDITOR LAURA HUGHES SAT DOWN WITH GERT BOS, PRESIDENT-ELECT OF THE REGULATORY AFFAIRS PROFESSIONALS SOCIETY (RAPS) TO LEARN ABOUT HOW EUROPEAN MEDICAL MANUFACTURERS CAN BEST PREPARE FOR INSPECTIONS IN CHINA. Bos, who spoke recently at the RAPS Regulatory Conference in Brussels provided insight on these inspections which are conducted on behalf of the National Medical Products Administration (NMPA). PUT SIMPLY, WHAT DOES THE INSPECTION PROCESS CONSIST OF? The inspection is usually conducted by three or more inspectors from China’s inspection agency - the Centre for Food and Drug Inspection (CFDI), on behalf of the NMPA. Additionally, back at the agency’s headquarters there is a larger team who are also involved in the process. The inspectors on site may contact these China-based team members during the inspection if any questions or issues arise. During the inspection, the inspectors may take pictures, videos, or samples which will be shipped to China for further testing. HOW ARE THE INSPECTIONS TYPICALLY ARRANGED? The NMPA will provide the legal agent in China with notice and a rough timeline prior to the inspection. Following a discussion between NMPA and the manufacturer the inspection dates will be finalised. WHAT ARE THE KEY ASPECTS MANUFACTURERS SHOULD BE AWARE OF PRIOR TO INSPECTION? In order to optimally prepare for the inspection, it is vital for the manufacturer’s regulatory team to know and understand China’s regulations and standards to the best of their ability. Additionally, the inspection involves multiple departments to work together alongside the agent in China.

Other consequences may include a responsible staff member not being permitted to work in a certain field in China for a five-year period – which in effect forces a career move to another sector. In the instance that non-conformities occur and there are areas to be disputed, a statement or explanation must be provided within 10 working days after receiving the result notice from NMPA. Following the implementation of any Corrective Action Preventive Action (CAPA), a CAPA progress report will need to be provided within 50 working days. Once all CAPA is completed, the manufacturer can apply for the risk control measures to be relieved. DO YOU BELIEVE THAT ADVANCES IN TECHNOLOGY HAVE HELPED TO KEEP FACILITIES OPERATING AT GOOD MANUFACTURING PRATICE (GMP) STANDARD LEVELS? Certainly, they have.

HOW DO THESE INSPECTIONS DIFFER TO OTHER PARTS OF THE WORLD? Aside from the different regulations and standards, it is important to consider the different culture and expectations here. Additionally, the scale and focus of the inspection could differ from other regulators so it is vital to understand and know as much as possible about what will be required in advance of the inspection.

In GMP, a number of aspects have been facilitated over the years by technological improvements. A key part is the assistance provided by computers within production processes, quality assurance checks and verifications, and in ensuring the validation of consistent products and batches. Computers are able to improve the reliability of these processes, whilst playing key roles within elements such as security and access control to sites.

WHAT ARE THE MAJOR CONSEQUENCES OF FAILING AN INSPECTION? In the case of an inspection failure, NMPA will implement risk control measures which may include suspension and cancellation of the certificate, or a forced recall in serious cases. Failure could also result in fines for the company, and in some instances for the legal agent also.

Of course, there problems could occur as people may attempt to hack into any control or protection system, and so any of these advancements come with a strong call for cybersecurity measures.

An important thing to note is that the inspections will be carried out in Chinese, and so it is important to have enough translators and moderators available onsite who are capable of translating the technical Chinese back and forth into your native language.

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THERMOFORMING

DAVID STIRLING, GROUP CHIEF EXECUTIVE OFFICER, ZOTEFOAMS EXPLAINS HOW THERMOFORMING COULD OFFER MEDICAL DEVICE MANUFACTURERS THE FLEXIBILITY TO DESIGN AND PRODUCE A VARIETY OF CUSTOM THERMOFORMED APPLICATIONS IN A COST EFFECTIVE MANNER.

he medical device industry remains one of the worldâ&#x20AC;&#x2122;s most heavily regulated sectors, with ever growing demands that require new, technologically advanced equipment and applications. Consequently, now more than ever, medical device manufacturers are relentlessly seeking innovative, cost effective and most importantly, quality controlled technologies and processes to remain competitive. Typical manufacturing processes, such as injection or blow moulding, are being surpassed by alternative solutions that offer greater production benefits with lower costs. One process in particular that is attracting significant interest for medical devices is thermoforming. Thermoforming is the process by which heat is applied to a thermoplastic material, which, along with the subsequent application of pressure or vacuum, enables three dimensional shapes to be produced from a flat sheet. In vacuum forming, a sheet of thermoplastic material is clamped into a frame and shuttled into an oven. The hot sheet is then either stretched over the mould, also known as a male moulding tool, or inside the mould, otherwise known as a female moulding tool. It is then drawn by vacuum to a desired shape. Compression moulding on the other hand sees the material heated in an oven before being transferred to a press outfitted with a cold or near ambient temperature mould, the material then cools under pressure. Thermoforming has become the production process of choice for many manufacturers due to its high quality finish that produces quality on a par with injection moulding, but with a faster turnaround time and lower tooling costs. It is compatible with a variety of materials, including polystyrene, polyvinyl chloride and polyethylene (PE), each offering unique properties for custom thermoformed solutions.

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THERMOFORMING

When selecting materials for thermoforming medical support applications, such as prosthetics, it is vital manufacturers consider the potential risks, particularly if the device will be in direct contact with the human body, and evaluate how the manufacturing method may, or may not, alter the components of a material and ensure they comply with rigorous industry requirements. Zotefoams, a British manufacturer of closed-cell PE, polyvinylidene difluoride (PVDF) and nylon (PA6) foams for demanding industrial applications, has increasingly recognised the properties of its polyolefin foam range that can provide a more advanced, sophisticated element to thermoforming. Zotefoams claim its polyolefin product, Plastazote, is the most cited thermoplastic foam material within medical literature. Most foams today are chemically blown, with the plastic heated and mixed with a blowing agent to produce expansion. This process is more difficult to control reliably than physical expansion and can result in a product with variable densities and different properties in different directions. The chemical blowing agent is then released over time, producing odour and potential fogging. However, the notable mechanical characteristics of Zotefoamsâ&#x20AC;&#x2122; PEbased foam ultimately stems from Zotefoamsâ&#x20AC;&#x2122; unique manufacturing technology that uses only pure nitrogen to expand foams. This three stage, environmentally friendly process ensures the production of pure, chemically inert foams, with uniform cell structure and regular cell walls due to the free environment in which they are expanded in. The process takes place without the use of a mould and very little in built stress, and with little tendency to distort during conversion; both of these features make the foam easy to process and fabricate. Compared with other thermoformable materials, these PE products offer excellent chemical resistance and meet recognised industry standard, ISO 10993. Being cross-linked, PE can maintain its structure even at temperatures above its softening point, enabling

ZOTEFOAMS ÂŠ thermoforming techniques to be used with a combination of heat and pressure and warranting the production of more complex shapes for a wide variety of medical healthcare applications, including podiatric, prosthetics and orthotics. It can also be used as a form of protection for diagnostic medical devices as it allows optimum impact resistance for sensitive or fragile parts whilst maintaining purity if the packaging is cut, as no shedding occurs.

Zotefoams claims its polyolefin product, Plastazote, is the most cited thermoplastic foam material within medical literature.

Together with the right material, thermoforming can offer medical device manufacturers a cost effective solution with the flexibility to design and produce a variety of custom thermoformed applications. From rigid plastics to soft touch foams, this cutting edge process allows manufacturers to transform advanced, raw materials into highly protective, industry compliant

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THERMOFORMING

DAVID RUSSELL, GENERAL MANAGER OF CONSULTANCY DAVID RUSSELL ASSOCIATES, TALKS ABOUT INNOVATIONS WITHIN BLOW MOULDING AND THERMOFORMING.

STOP GUESSING, START SIMULATING within the mould. But in blow moulding and thermoforming the thickness is dependent on how the material will stretch during moulding. Experience has always been used to predict stretching but for many complex 3D designs experience is not enough – modern computing power has to be used to optimise cost and performance.

“There is a better way for everything – find it!” – Thomas A Edison “If you always do what you’ve always done, you’ll always get what you always got!” – Henry Ford These statements are as applicable today as they were 100 years ago. We have to continuously innovate or someone else will! We have seen how 21st century computing power has driven innovation and reduced costs – but not everywhere in the plastics industry. Computer simulation has been a fundamental step in design for injection moulding for more than 40 years. But, even with the advent of industry 4.0 principles, the massive benefits seen through simulation in the injection sector have not been replicated in blow moulding or thermoforming, where it is sometimes regarded as a cost, rather than a benefit. Product strength in ‘closed mould’ plastics processes is achieved by controlling the wall thickness

Simulation software, when used to optimise design, tooling and heating, can improve technology, efficiency and competitiveness. Organisations who have adopted simulation are reaping the benefits in new products by: l reducing development time and ‘time-to-market’ l avoiding the delays, cost and hassle of tool modifications l identifying (and fixing) quality issues before they become a problem l optimising process settings and resulting in keener pricing decisions In the blow moulding sector, simulation software will automatically optimise the shape and temperature profile of preforms and parisons. In thermoforming, simulation software will automatically optimise the oven settings to achieve best thickness. Once organisations gain experience in simulation, it is being used to optimise existing process settings to reduce cycle times and costs. One packaging thermoformer investigated the effect of varying their machine settings by +/- 15%. This meant looking at the effect of 16 variants such as something which would have incurred an inordinate amount of people time, machine time and wasted materials. They turned to simulation to carry out the investigation by ‘batching’ the variables, and within a few hours they were able to compare the different thickness outcomes to arrive at better settings. For zero cost they took 10% out of cost, resulting in 12.5 tonnes of sheet saved annually. This meant that one job more than paid for the software. Also, of increasing importance prior to tooling, is the use of Finite Element Analysis (FEA) to check that products will meet performance criteria. It is important to note that the accuracy of FEA is dependent on the accuracy of the data it is fed with. Meaningless ‘nominal thicknesses’ predictions will no longer be enough for FEA, and computer simulation will be needed to provide accurate details of the thicknesses across the whole product. Consultant, David Russell, played a key role in introducing the innovative high pressure forming technology to Europe 30 years ago and wishes he had been able to use simulation back then in design discussions with customers, and to better identify quality issues (e.g. thinning) before tools were ordered. Russell now promotes innovation via simulation and heating.

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MAKING WEARABLE DEVICES

MEDICAL PLASTICS NEWS EDITOR LAURA HUGHES SAT DOWN WITH MATERIALS GIANT, COVESTRO TO DISCUSS THE ORGANISATIONâ&#x20AC;&#x2122;S ROLE IN THE DEVELOPMENT OF PLASTIC WEARABLE MEDICAL DEVICES.

Walton: We see a trend towards smaller batteries and alternative power sources, such as solar and kinetic power, along with the influence of data transmission and IoT advancements on new antenna and 5G technologies. There has been increased initiative from the government, academia and businesses to incentivise collaboration along the supply chain, with the goal of accelerating the introduction of commercially viable products. An increasing number of material suppliers and manufacturers are also working to accommodate the wide range of volume requirements.

WHO'S IN THE ROOM Bentley Mah, senior technical sales specialist, Baymedix, Covestro / Doug Hamilton, global healthcare marketing leader, polycarbonates, Covestro / Jim Walton, business and market development, specialty films, Covestro FIRSTLY, HOW DO YOU FEEL THE MANUFACTURING PROCESS FOR PLASTIC WEARABLE MEDICAL DEVICES HAS CHANGED OVER THE PAST COUPLE OF YEARS? Mah: This is an exciting time in the wearables market as there has been a convergence of technologies to greatly aid in the manufacture of these products. New materials and technologies have emerged, including conductive inks and fabrics, thermoplastic polyurethane films that can be printed with conductive inks, thermoformable foams, the miniaturisation of sensors, 3D-printed plastics, and innovative skin attachments and new interface technologies. Hamilton: Wearable devices are dramatically improving the patient experience, leading to increased global adoption and volume reliable raw material supply chains are critical to this growth.

WHAT ARE THE MAIN CHALLENGES ASSOCIATED WITH MANUFACTURING WEARABLE PLASTIC DEVICES? Hamilton: Data transmission and data security (e.g., balancing consumer and patient privacy with data analytics) are prominent challenges facing the industry. The growth of wearables sheds light on design challenges, such as the light weighting of devices, as well as new production needs. For example, manufacturers need to produce thin-wall plastic parts in mass quantities by leveraging experience from the consumer electronics market. Additionally, as devices move out of the hospital and into the home, there are new design challenges to ensure reliability and durability at price points that support widespread adoption. Global, multi-site production of highvolume medical wearable devices requires careful planning for product consistency around the world.

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MAKING WEARABLE DEVICES

Mah: As many industries move towards a more circular economy, integrating sustainability in the life cycle of wearables is increasingly important. It’s also critical to implement industry standards and for materials to undergo the necessary testing for skin requirements and/or biocompatibility. WHAT DO YOU THINK ARE THE ESSENTIAL FEATURES OF WEARABLE DEVICES? Mah: Human factors and interfaces play a key role in the functionality of wearable devices. These design elements include ease of placement or positioning (e.g., locations with minimal movement or abrasion), low trauma attachment, ease of use, minimised effect on day-to-day anatomical movement or interaction with clothing and bedding, and low trauma removal. To ensure comfort for patients, wearables must also be lightweight and feature a low-profile thickness and minimal surface area with a small yet safe power source. Overall, consistency and reliability are key, from accurate data transmission to physical durability. Walton: Cost is also a critical factor for any consumer-facing medical wearable device and can be easily achieved as a result of recent material and process developments.

Existing device moulders, manufacturers and medical converters of flexible materials are well-positioned, but gaps in materials production and manufacturing will need to be filled as certain devices gain traction.

DO YOU THINK INDUSTRY 4.0 HAS PLAYED A PART IN THE DEVELOPMENT OF WEARABLES? Mah: Wearables and industry 4.0 go hand-in-hand as both are driven by connectivity to external sources, including smart phones, computers, the cloud, hospital IT systems, etc. This revolution has contributed to sensor measurement, software analytics and algorithms to interpret advice or provide a diagnosis. The ability to record and store information on both the devices and on the external appliances will allow for communication to the healthcare provider and ensure compliance with medical prescriptions and remote diagnoses. Additionally, wearables are inherently about data capture. Industry 4.0 has played an integral role in developing data transmission security and privacy by ensuring these features are clearly established and expectations are communicated. Hamilton: The implementation of 5G will allow data to be seamlessly communicated between all necessary parties—from patients to healthcare providers to medical devices and more. HOW DO YOU SEE THE ROLE OF WEARABLES WITHIN THE MEDICAL PLASTICS FIELD CHANGING IN THE FUTURE? Hamilton: Innovation in wearables will grow for the foreseeable future fueled by a patient focus on wellness and preventative medicine and constrained only by the technical challenges of consolidating biometric measurement systems into unobtrusive devices. Wearables will require their own ecosystem of devices that go beyond traditional applications, and advanced communication technologies like 5G will be especially impactful on wearables’ ability to interact with the surrounding world. Additionally, low-volume, specialised equipment currently found in hospitals and clinics will be superseded by highvolume wearables. Mah: Future technologies may increase the need for new plastic materials, such as conductive or resistive foams, and as smarter wearables emerge, they may replace current technologies, including watches, bandages and EKG/EEG tabs. Existing device moulders, manufacturers and medical converters of flexible materials are well-positioned, but gaps in materials production and manufacturing will need to be filled as certain devices gain traction.

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MAKING WEARABLE DEVICES

HOW TO DEVELOP

WEARABLE MEDICAL DEVICES TOM MCLEAN, VICE PRESIDENT, INTEGRATED DELIVERY SYSTEMS RESEARCH AND DEVELOPMENT, WEST PHARMACEUTICAL SERVICES DISCUSSES THE CHALLENGES ASSOCIATED WITH DEVELOPING PLASTIC WEARABLE MEDICAL DEVICES.

here are many challenges associated with developing wearable medical devices which can be customised to meet both the healthcare provider and patientâ&#x20AC;&#x2122;s needs.

THE APPROACH A platform approach works by attempting to create the the design of a wearable delivery system with maximum design flexibility, whilst meeting as many applications and customer and patient needs as possible. In order to implement this platform approach during development some conflicting design requirements must be dealt with, which can be categorised into the following areas: l The intended user/patient population and their specific needs. E.g. age, gender, BMI l Therapeutic characteristics such as the frequency of dosing (E.g. daily) the dose volume, delivery time, delivery rate (E.g. bolus injection) and the delivery location on the body l Molecule/drug characteristics such as drug viscosity, temperature (cold chain), ultra violet or light sensitivity, and shelf life l Business and marketing considerations including product cost, the ability to differentiate or brand, and the ease in which the wearable and drug product are consolidated into the final combination product

By understanding these conflicting application and user requirements from the start, West Pharmaceutical Services is able to define which product features are fixed, which are designed to operate within a range and which features can be customised for a customerâ&#x20AC;&#x2122;s application. MEETING EXPECTATIONS In terms of expectations for manufacturers from regulatory agencies, there is currently a potential lack of clarity. This is because wearable devices are still very new to the industry, with only a few products receiving marketing approval up to now. West Pharmaceutical Services is actively involved with the international standards organisations (ISO TC 84) that are developing guidance for wearable delivery systems (E.g. on-body delivery systems) to ensure we understand the expectation of not only the regulatory agencies but also all stakeholders. The company also work closely with customers and participate in meetings with the regulatory agencies for specific applications, in order to ensure adherence to regulatory expectations for each application. One example of a new expectation from the regulatory agencies is demonstrating the consistency of dose delivery over the defined delivery time for a wearable device. Most delivery systems (pen injectors, pre-filled syringes, autoinjectors) in the market today have not needed to demonstrate delivery consistency due to their lower delivery volumes (less than 2ml) and delivery times (typically less than 15 seconds). Wearable devices

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MAKING WEARABLE DEVICES

typically intend to deliver larger volumes over a longer time. There is a need to define a delivery profile (delivery volume over time curve) with limits, and to demonstrate from this that the device can consistently meet this defined curve - this can often be a challenge for many wearable delivery technologies. ENSURING QUALITY As manufacturers itâ&#x20AC;&#x2122;s important to ensure that you maintain quality expectations, and quality starts with how the product is designed and developed. West Pharmaceutical Services follows a stage gate product development process where we assess the performance of the product and manufacturing processes against pre-defined requirements at each gate. The company also utilise theoretical analysis tools (E.g. MoldFlow) during the early stages as part of the design for excellence (DFx) program, whilst the statistically based testing plans throughout development help to provide confidence in the product reliability. Once a product is developed and out on the market, West Pharmaceutical Services has a dedicated team that conducts market vigilance of the product, assesses any issues observed in the field and looks at data trends for any signs of potential quality issues. This information is then fed back to the development team for potential product improvements.

application as you develop a wearable device. The information gained from these types of studies leads to specific requirements and product features that ensure a patient is able to use the product and receive their therapy as intended. At West Pharmaceutical Services we consider things like: l Form Factor that provides a positive response from the user l Ease of use, starting with how the product is removed from the packaging through the completion of the dose l Understanding how to use and gain confidence when using the delivery system MATERIAL CHOICE It can be challenging deciding which materials to use. When selecting materials for wearable devices, West Pharmaceutical Services first looks for material types that are fit for use within the wearable delivery technology â&#x20AC;&#x201C; whether that is a polycarbonate, acrylonitrile butadiene styrene or another type of polymer. We then determine if there is proven biocompatibility for medicinal use, and if not, we will conduct testing at an independent, third-party facility to ensure that all industry standards are met. In addition, we seek out materials whose continuity of supply is most reliable. Patients rely upon drug delivery technologies to ensure adherence to their prescribed therapeutic regimens; thus, reliability is crucial. Dual-sourcing options or a business continuity plan is essential from a procurement perspective when selecting any material used within the device. CONCLUSION The ultimate goal is for a patient to want to use the wearable delivery system as prescribed, because it is compliant with their therapeutic regimen and therefore results in desired health outcomes for the patient.

User research and human factors studies are critical when making wearable devices. This is because firstly, it is an expectation from the regulatory agencies that you have conducted human factors studies and have submitted this as part of a marketing application. Additionally, it is vital to have a good understanding of the user, the use environment and the challenges of the specific therapeutic

The ultimate goal is for a patient to want to use the wearable delivery system as prescribed, because it is compliant with their therapeutic regimen and therefore results in desired health outcomes for the patient. 30

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ROBOTICS

ike many manufacturing processes, injection moulding (IM) could benefit considerably from automation. While the move towards offshoring work in the early 2000s impacted its adoption across Europe, Sumitomo (SHI) Demag is reporting a change in attitude and reversal in this trend, with a growing number of plastics processors embracing robotics to stay ahead of their competition. No longer the preserve of a few operators with specialist needs, statistics released by the European plastics machinery organisation Euromap shows that the number of IM machines sold equipped with robots rose from 18% in 2010 to almost a third (32%) in the last quarter of 2018. Additionally, with Euromap’s unveiling in 2018 of the first digital Industry 4.0 standard, automation looks set to become more commonplace in plastic processing facilities in the future. Nigel Flowers, managing director at Sumitomo (SHI) Demag comments: “There has been a significant upwards trend towards automation in plastics processing. Part of this has been driven by demand for more flexible solutions, so the use of 6-axis industrial robots in precision moulding especially is certainly more commonplace today. Additionally, the price gap between Cartesian and industrial robots has closed markedly, while at the same time, they’ve become easier to programme and simpler to integrate.”

are typically getting smaller and smaller. When you are handling or trying to remove parts from a mould that measure just millimetres, a dexterous robot is very important.” In 2009, the Sepro Group, in partnership with Sumitomo (SHI) Demag, developed a special range of robots adapted to the company’s popular Systec and IntElect systems. Both systems are widely used in electronics, automotive, medical and packaging moulding. Noting the benefits of integrating robotics into precision IM systems, Flowers says: “In precision moulding applications, robots are usually chosen for their range of operation, accuracy, repeatability and cleanliness. Sometimes the customer needs to transfer parts, insert load, apply labels or remove complex parts in non-linear movements. For packaging, robotics is primarily used to make customer applications run faster and more costeffectively. With take-out times of 0.5 seconds or less, it can sometimes be faster to use a robot to remove parts than to let them fall under gravity.” AUTOMATION IN ACTION The simplest robot applications involve sequencing with the moulding cycle to remove finished parts from the machine and placing them on a table. Another common task involves stripping sprues and waste from around the mould and placing them in a granulator for recycling. In-mould labelling (IML) is another prime area for automation, and in recent years European adoption in packaging applications has really taken off. Speed is all-important in this role, and Sepro offers a series of high-speed side-entry robots, incorporating label dispensing and placing technology. In-mould insertion is also common practice when creating automotive parts. In particular fabric insertion, which is a major feature of many IM installations. Other examples in motor industry applications involve the exposure of moulded bumpers to a gas flame in preparation for downstream spraying.

Flowers adds: “In terms of robotic configurations, there is certainly plenty of choice. If all the robot is doing is moving a part from the moulding machine, a 3-axis robot should be sufficient. However, a 5 or 6-axis robot can perform more complex manipulation tasks. Precision components, such as electronic parts or hearing aids,

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ROBOTICS

NIGEL FLOWERS, MANAGING DIRECTOR OF SUMITOMO (SHI) DEMAG EXPLAINS THE BENEFITS ROBOTS CAN OFFER WITHIN THE MANUFACTURING PROCESS, INJECTION MOULDING. Vision can be added to IM robotics to monitor quality and create a traceability record. Sumitomo (SHI) Demag continues to invest a lot of research and development into this area. For example, the company has previously built a cell whereby the master computer connects to the robot, a tiny camera inside the cavity of water flow tubes being moulded, and the laser marking station. These images are then cross referenced with ‘pass/ fail’ shots held in the system and if the part passes the quality checks it is moved to the labelling station by the robot. A unique part code label is printed and adhered to the side of each moulded flow tube. The two images taken by the camera and corresponding part ID code is then stored by the system before the robot lays the finished product into a blister tray. Most recently, the company, in partnership with Kurz, created an automated cell to create a super-sleek, sensory door trim with a high gloss day night design. Featuring a 6-axis robot with gripper, this innovative automotive cell incorporates an advanced in mould decorating (IMD) feature whereby foil is added to the door trim panel during the bonding process to provide touch functionality. Process data is then integrated into the higher-level manufacturing executive system (MES) to generate the unique data matrix sensor, which is bonded to the part to give each individual part its traceability data. Other elements of this automated cell include a cutting station for sprue removal, a UV curing station to give the car trim its high gloss, a cleaning station for automated polishing, and a visual inspection chamber. For hygiene sensitive markets, such as medical and healthcare, it is possible to attach a robot to the frame of the IM machine, enabling manufacturers to automate functions like handling and packing within a compact and enclosed cleanroom-standard cell. Flowers states: “Once you have the filter and laminar airflow, the robot is sitting in a cell that’s cleaner than the average operating theatre!” FASTER RETURN ON INVESTMENT Speed, yield, repeatability, reliability, multi-tasking and long-term cost saving are all reasons why end users might opt for a robotic IM solution. Many plastic processors are finding the capital cost of robot-equipped IM machinery more affordable, which is helping to justify the return on investment (ROI). “Being able to operate around the clock inevitably increases productivity and consequently profitability,” says Flowers. “Also, there is greater awareness that with today’s industrial robots, a processor won’t just be specifying for a single application. A robot today can be reprogrammed to support a different product. Some customers are beginning to switch from Cartesian robots to industrial 6-axis systems, which evidence suggests is connected in part to future-proofing investments.” For many, the strongest associations when it comes to sophisticated robotics are with large and already highly-automated operations, such as automotive plants. In fact, robotic development is just as rife among smaller-scale manufacturers.

“Even packaging converters with just three or four IM machines are seeing the benefits of being able to extend their working hours,” says Flowers. “If they want to move to longer shifts, they may be looking at the simplest solutions such as Cartesian robots.” As those companies grow, plan for the longer-term and put more emphasis on in-built flexibility, there is always the option of moving to a 6-axis alternative. ADDRESSING CHANGING WORKFORCE NEEDS For small to medium sized plastics processors in Europe, the shortage of skilled labour remains a key issue that can hinder innovation. However, proximity of a plastics manufacturer to domestic customers is a key advantage. With labour costs rising, robots can help local plastic processors to maintain consistent performance and consistent quality. Flowers explains: “With industrial automation, one operator can look after, say, 10 machines. You can achieve more consistent output while reducing manufacturing costs.” Rather than being a jobs taker, there’s also strong evidence to suggest that adoption of robotics create more interesting and varied jobs. This is driving the need for more advanced engineering skills. There’s little doubt that in terms of flexibility and dexterity, integrating robotics and automation into IM set-ups can increase manufacturing competitiveness. Flowers concludes: “As we enter the era of Industry 4.0 there is a definite shift towards integrated production cells, with a need for robotics and peripheral equipment to work seamlessly together.”

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DIGITAL HEALTH

TIME FOR A CHECK-UP REGULAR CONTRIBUTOR REECE ARMSTRONG WRITES

t Medical Plastics News, we’re all about polymer engineering. But every now and then we get the offer to test out some cutting edge medical devices. The electro interstitial scan (EIS) sensor analyser, which is based at John, Bell and Croyden's pharmacy in London promised so much, I couldn’t resist going to check it out. The pharmacy’s Nutri-Clinic is described as a bespoke personalised nutritional assessment, during which a detailed account of a person’s history of health concerns is taken by a doctor. This ‘detailed account’ is achieved using a class II medical device known as an Electro Interstitial Scan (EIS) Sensor Analyser developed by Minerva Research Labs. The machine consists of six electrodes which were placed onto my feet, hands and forehead to the measure the fluid between the cells throughout my body. The idea is that by measuring this interstitial fluid, the doctor can then perceive a person’s current vitamin, mineral and hormonal imbalances within your body.

Customers will be taken through an entire life-style assessment, during which they will find out what kinds of foods they should be eating and even what supplements they can take to counter any imbalances. My only worry was that, as a pharmacy that sells many premium supplements, customers will only be recommended John Bell & Croyden products, making the service rather predatory in regard to patient care.

My appointment was shorter than the usual 90-minute assessment, but I was still able to gain an insightful look into the workings of my own body. The scan takes around three minutes, during which I was told to stay still unless the doctor had to take my readings again. After using the EIS device, I was taken through an outlook of my health, with the doctor taking me through everything from my calcium levels, to a past trauma highlighted by my neurological functions. Knowing that the device is able to tell that a person is suffering mentally is both scary and amazing. More so, it offers another level of information to doctors, rather than them having to depend solely on a patient’s own account; something which for those less-inclined to speak up about their problems could be a big help. Thankfully, all my body’s essential minerals were at the correct levels and my gut’s health too was optimum thanks to an alkaline pH balance. Importantly, the health information I gained during the visit was detailed enough for me to know if I needed to either make changes to my lifestyle or to follow up with a doctor for any concerns I might have. Overall though it was an affirming experience to know that I’m a fairly healthy individual, an outcome I’ve never really gained from visiting a GP or a pharmacy prior to this. *Note that this service isn’t for diagnostic purposes, but simply a guideline to a healthier lifestyle and to see if you may need follow up appointments with a GP. The full Nutri-Clinic service doesn’t end with the scan like my appointment did.

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DIGITAL HEALTH

However, when following up with Dr Vidhi Patel - the doctor in charge of the new service – she assured me that her patients’ health and indeed trust was her first and only priority, regardless of the service being offered by a prestigious pharmacy. Some might balk at the price tag of £180 but - as my colleague pointed out - you’d pay the same for your car’s MOT so why not for a service which can indicate whether or not you need to follow up with your doctor. More importantly, services like this, and other in-house offerings, get consumers off of the streets and into the pharmacy. With the emergence of electronic prescription services and digital appointments, pharmacies need to offer ways in which customers feel the benefit there and then. Whether it’s a holistic check-up from John Bell & Croyden or getting a suspicious-looking mole examined, pharmacies can be the first stop for patients worried about any ailments. For those lucky enough to be sent on their way without anything to worry about, GPs and other NHS departments may just avoid another unnecessary appointment; a small but vital time-saving for an already over-stretched service.

The machine consists of six electrodes which were placed onto my feet, hands and forehead to the measure the fluid between the cells throughout my body.

TESTING & INSPECTION

A REALITY CHECK WEB CONTENT EDITOR IAN BOLLAND VISITED VISION ENGINEERING’S HEADQUARTERS IN WOKING WHERE HE WAS GIVEN A SNEAK PEEK OF THE COMPANY’S NEW PRODUCT – THE DEEP REALITY VIEWER – WHICH WAS LAUNCHED AT CONTROL IN STUTTGART EARLIER THIS YEAR.

ase of use, deep analysis and vivid perception are the three priorities that went into the development of the company’s new Deep Reality Viewer (DRV).

Vision’s new 3D imaging microscope is designed to work across several sectors, not least the life science and medtech industries. Unlike traditional mono digital microscopes, Vision Engineering’s DRV creates stereo high definition 3D images, without using a monitor or requiring operators to wear headsets or specialist glasses: Images ‘float’ in front of a mirror. Using Vision Engineering’s patented TriTeQ³ digital 3D display technology, the DRV-Z1 (Zoom model 1) incorporates a microscope and is the first device of its class to be launched by the manufacturer. The DRV can be used for both detailed analysis and quality control. During the demonstration, implantable medical devices such as pacemakers were used as an example to illustrate the importance of quality control in the sector. It can also be used for a host of other processes, including measurement, polishing and finishing, bonding and joining, approval or liability testing, soldering, alignment and positioning, marking, etching, coating, and dissection and cutting. It is suitable for use in many applications, not least plastic medical devices. Vision designed the DRV using its core TriTeQ³ technology, which aims to exclude sensory isolation, in turn allowing the product to exploit the user’s peripheral vision.

split in favour of digital within the next two to three years. The most fascinating demonstration was an analysis of the spine of a dog, using 3D imaging of a computed tomography (CT) scan of the animal. The image could be moved around with ease allowing for a more detailed examination and improved insight from healthcare professionals. How simply the spine could be analysed from all angles, and the way the technology allowed the user to analyse certain parts within a body, almost made the standard x-ray feel dated. Ahead of the product’s launch, Paul Newbatt, sales and marketing director said: “TriTeQ blends Vision Engineering’s long established, industry proven and award winning optical stereoscopic technologies and digital monoscopic technologies. DRV-Z1 delivers a technological breakthrough and is a game changer for inspection and quality control processes.”

TriTeQ³ is the firm’s stereo image presentation system designed to provide fully interactive real time natural 3D visualisation with outstanding depth perception. The company has also received two Innovate UK grants for optical and digital technical development in 2018-2019, totalling £750,000 – helping to support the development of the DRV. The name came about because the company says it “sees the commonality between augmented reality and virtual reality”. Managing director Mark Curtis said: “It essentially provides real-time, full high definition stereo images. It then gives you full communicability, full sensory stimulus. So, if you’re on the production line, and you see something you don’t like, you get your supervisor to look at it. It’s as simple as that.” Part of the company’s strategy was to exploit potential interest in the latest trends emerging in the sector, such as virtual reality, augmented reality, the internet of things, blockchain and artificial intelligence. Curtis explained that the split between the optical systems and digital systems that Vision develops is currently at 50/50, but with the trend moving in a more digital direction, he foresees a 70/30

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COATINGS

An extra layer TOGETHER MARTIN DAY, DIRECTOR OF EUROPEAN SALES AND MARKETING, ROSS ELLIOT, PROCESS OPTIMISATION MANAGER AT THE CARCLO TECHNICAL PLASTICS (CTP) FACILITY IN BRNO, CZECH REPUBLIC AND MICHAL BENES, BUSINESS DEVELOPMENT MANAGER DISCUSS THE DIFFERENT TECHNIQUES FOR APPLYING COATINGS TO INJECTION MOULDED PLASTIC COMPONENTS.

oatings have traditionally been used to provide functional and aesthetic properties to a substrate for centuries. For example, paints and precious metals are used to decorate a range of surfaces and lacquers are used to provide a hard and protective surface to wooden articles.

This practice is routinely extended into the plastic manufacturing sector across a range of applications from the automotive industry to defence. Metallic coatings can be applied to provide reflective, conductive or hard wearing surfaces, polytetrafluoroethylene (PTFE) can be used to reduce the friction across a surface and elastomers can provide a “soft touch” feel. HARD COATING Over many years, CTP has developed a particular expertise in applying hard coatings (lacquers) to plastic materials such as polycarbonate. In one such application, a lacquer is applied by a flow coating process to CCTV camera domes to increase surface hardness, thereby rendering them resistant to vandalism. In another, the lacquer is applied by dipping or spraying technology to helmet visors for aeronautical and firefighting applications. Such lacquers are primarily intended to enhance surface hardness and abrasion and mar resistance. They can also be formulated to provide anti-mist performance for the user and resistance to ultraviolet, elevated temperatures, solvents and other chemicals while not impacting optical clarity of the substrate.

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COATINGS

Coating thicknesses are generally six to twelve microns but are dependent on customer specification. Hard coatings make plastic substrates hard and brittle but, by balancing the coating thickness, a level of flexibility in the component can be retained; this is especially important with facial protection products such as visors, manufactured to meet demanding international standards for personnel protection. In both cases, there are a number of considerations to maximising product quality and ensuring health and safety compliance. For example, the substrate needs to be kept clean. This can be assured by manufacture in controlled conditions, such as a classified cleanroom in order to minimise particulate contamination. CTPâ&#x20AC;&#x2122;s lines operate to ISO class five or six with control of both temperature and humidity. However, product handling between the plastic manufacturing line (e.g. injection moulding machine) and the coating line need careful planning to ensure the article enters the coating line as clean as possible. Once coated, the component may require drying at room or elevated temperature and, once again, good handling is essential. In addition, component and process design need to consider coating at an early stage rather than as an afterthought. This is because minimising in-moulded stresses is critical to achieving a high quality coating. In some cases, a sprue/runner can be used to hold the component through the coating process but will need to be removed afterwards. If a full hot runner system is preferred for injection moulding the component, an alternative means of holding it through the coating process will be required. Deciding which process to use requires consideration of the customerâ&#x20AC;&#x2122;s specification, critical areas of the component, and analysis of moulded-in stress amongst other considerations. CTP can advise on design change requirements to ensure maximum coating performance. One important consideration is lacquer run-off points. Where the component has multiple run-off angles, CTP has developed automated, six-axis robotic coating capabilities for flow and dip coating complex components, giving the ability to supply at maximum performance and cosmetic levels. When designing a coating line or facility, consideration must be given to handling the lacquer and any waste and extraction of fumes. Many coatings are solvent-based, and attention must be paid to local regulations.

HYDROPHILIC COATING CTP also applies functional coatings to medical diagnostic components. These can include surfactants for hydrophilic purposes. In commercial production, the same processes can be used however, in one lower volume and low complexity application, the component is manually dipped into the surfactant and allowed to dry at ambient temperature. Specifiers of coatings should be aware that the coating materials are generally proprietary. CONCLUSION Coatings are often a critical aspect of product performance; however, careful consideration should be paid to all aspects of design for manufacture, material selection and process design and optimisation to ensure the maximum performance of the coated product.

Component and process design need to consider coating at an early stage rather than as an afterthought. This is because minimising in-moulded stresses is critical to achieving a high quality coating.

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EVENTS

TCT Show, Birmingham

THE TCT SHOW PLANS TO SHOWCASE UP TO DATE INFORMATION ON ADDITIVE MANUFACTURING, 3D PRINTING, AND DESIGN AND ENGINEERING TECHNOLOGY

T The TCT show aims to create an environment for insight, intelligence, innovation and business.

THE TCT SHOW WILL TAKE PLACE FROM 24TH TO 26TH SEPTEMBER 2019, AT THE NEC IN BIRMINGHAM, UK.

he show which has successfully taken place for over 20 years, will host more than 60 presentations from dozens of expert speakers for the 10,000 attendees from more than 40 countries this year. Companies such as Stratasys, Renishaw and Siemens will form part of the 300+ exhibitors at the event. There will also be around 35 product launches taking place at the event. The TCT show aims to create an environment for insight, intelligence, innovation and business, with visitors for the event consisting of manufacturers, designers, business leaders, early adopters, innovators and investors. The event also provides the opportunity to network with others in the industry. There will be a seminar programme which will feature talks on cutting edge applications, and the latest research on topics such as aerospace, automotive, medical,

dental, consumer and industrial product design. The TCT conference stage will host speakers from places such as the United Kingdom, Europe, United States and Asia. These experts will aim to present their knowledge about 3D technologies to attendees. The Inspex brand will also be present and attempting to increase awareness of metrology and inspection within 3D manufacturing. In 2018, TCT partnered with Create Education to deliver training for up to 300 students from year 9-11 during the show. Through locating this training hub on the show floor, the students were able to see what else the TCT show had to offer alongside their training, and then also given the opportunity to visit and talk to exhibitors. This yearâ&#x20AC;&#x2122;s show will also offer a similar feature as part of TCTâ&#x20AC;&#x2122;s mission to educate the next generation in the art and science of manufacturing.

EVENTS

Medtec China MEDTEC CHINA IS ASIA'S LEADING EVENT FOR THE MEDICAL DEVICE SUPPLY CHAIN.

edtec China has brought nearly a thousand suppliers of medical design, research and development, raw materials, accessories, processing technology and manufacturing services to China’s medical device industry since the first exhibition in 2005. At the show, you can find the parts and components needed for research and development, production, raw materials, and design and manufacturing technologies and solutions. The event’s audience consists of mainly medical device manufacturers, purchasing staff, engineers and quality inspectors. The Chinese medical device market claims to be growing at a compound annual rate of 16.8%, and according to the China National Pharmaceutical Industry Information Centre, among device types, imaging devices, in vitro diagnostics and high-value consumables are the top three sectors, accounting for 19%, 16% and 13%, respectively, of the total market.

Therefore, although in 2018, Medtec China attracted 354 exhibitors from 23 regions and countries in the world - this year event growth is anticipated. Medtec China expects 400 exhibitors, and more than 20,000 visitors from different regions in the world to be in attendance for this year’s show. The event will hope to provide the chance for exhibitors to meet thousands of buyers from medical device manufacturers. It will also aim to create an environment where new partnerships can be formed through discussing industry challenges and opportunities and learning from experts about medical device trends. There will be an exhibitor’s theatre, MDiT forum and regulation summit where products and technology will be showcased. Additionally, specialists from the government, universities and medical device manufacturers will come together to discuss their views on regulation, quality and technology.

The varied onsite conference schedule can be viewed on the event website. It is still not too late to register for this design and manufacturing event which will enable access to thousands of global suppliers, and also provide the opportunity to further explore regulatory updates in China, Europe and the United States. The 15th annual event will take place from 25th to 27th September 2019 in Shanghai World Expo Exhibition & Convention Centre, China.

It will aim to create an environment where new partnerships can be formed through discussing industry challenges and opportunities and learning from experts about medical device trends.

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Compamed Trade Fair: The facts 1

120,116 trade visitors from 155 nations

784 exhibitors from 37 countries

18th-21st November 2019

2 exhibition halls in the fair ground Düsseldorf, Germany

Show objective: To improve communication between suppliers and manufacturers

08:2019 NEW FAMILY OF BIOMATERIALS OFFERS POTENTIAL IN THE FIGHT AGAINST ANTIMICROBIAL RESISTANCE

actigon, a new family of biomaterials has been built by analysts at the University of Nottingham. Researchers believe that Bactigon could help in the fight against antimicrobial resistance. Biomaterials are used in lots of medical devices such as catheters and artificial hip replacements, so it’s important for them to stay sterile. In the case that the sterility becomes affected, bacteria can stick to the materials and form

biofilms – acting as a reservoir for infection. What’s special about Bactigon is that it aims to be able to prevent the formation of this biofilm. The material is currently being trialled in urinary catheters, in the hope of decreasing urinary tract infections which are a common complication of catheters. However, in the future, the material is intended to be tested in different devices.

COULD THIS BE AN EASIER WAY FOR DIABETICS TO MANAGE THEIR INSULIN?

connected device for injection pens has entered into negotiations for use within Sanofi’s diabetes care platform.

Biocorp’s smart sensor cap claims to be the only device created for this purpose which meets the accuracy requirements for a CE class IIb medical device. The connective feature of this pen hopes to eliminate the need for a person to manually log their dosage. The smart sensor cap works with a conventional insulin pen and is able to record the injection dose, date and time. The device then sends this information to a mobile application. The mobile application is able to create summaries of dosing over periods of up to 90 days. The app is compatible with both Apple iOS and Androids.

CHECK OUT... THE LATEST EPISODE OF THE MEDTALK PODCAST The most recent episode sees editor Laura Hughes, regular contributor Reece Armstrong and web content editor Ian Bolland chat about some of the latest news in healthcare. Armstrong talks about his reason for recently visiting John, Bell & Croyden Pharmacy in London, United Kingdom, whilst Hughes discusses the research on faecal transplants which has been published in respected journal JAMA, on a randomised, double-blind study in patients with ulcerative colitis. Bolland also highlights specific parts of the latest RB report titled, ‘Consumer Health Futures.’ You can listen to the latest episode on Soundcloud, iTunes and Spotify.