MPN EU Issue 54

EUROPEAN EDITION

MEDICAL PLASTICS news THE ROLE OF SINGLE USEPLASTICS DURING COVID-19 HOW TO COMPLY WITH EU MDR WHY PLASTIC IS AN IDEAL OPTION FOR PACKAGING

Perfect How to ensure success with micro moulding

ISSUE 54

May - June 2020

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CONTENTS May/June 2020, Issue 54

Regulars

Features

5 Comment Laura Hughes explains the role of single-use plastics during the pandemic

12 Paving the way Phillips-Medisize describes how a connected digital health platform paves a promising pathway

6 Digital spy

17 Going through changes Ian Bolland speaks to ICON about the importance of preparing for IVDR

9 News analysis 10 Therapy area focus: Orthopaedics 14 Cover story Accumold explores risk mitigation in micro moulding 34 06:2020

22 The future is automatic Axial3D discusses the important roles AI and 3D printing will play in the future 25 Back on track WuXi Medical Device Testing lists how to gain compliance under EU MDR as quickly as possible 27 Number one rose plastic explains why plastic is an ideal option for packaging 33 Validation: The process Sumitomo (SHI) Demag UK shows how validations can help to derisk projects

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editor | laura hughes laura.hughes@rapidnews.com head of content | lu rahman web content editor | ian bolland

Editor’s Comment

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LAURA HUGHES

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 © 2020 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.

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BPA Worldwide Membership ISSN No: 2047 - 4741 (Print) 2047 - 475X (Digital)

Why single-use plastics have been essential

DURING THE COVID-19 PANDEMIC

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or years manufacturers, researchers, and members of the general population, have been focusing their efforts on the need to recycle any plastics used within the medical sector. As a result, I think it’s fair to say that single-use plastics were painted in a negative light that implied the use of this material was sub-optimal. However, during the recent Covid-19 pandemic, single-use plastics have played an important role and one that deserves acknowledgement as a result of the bad press this material often receives.

During the pandemic, single-use plastics have been used for home delivery services, hand sanitiser bottles, and also by medical institutions who have been advised to doublebag clinical waste from any Covid-19 patients.

Cassie Bradley, sustainability and economy commercial manager for INEOS Styrolution Americas, highlighted the advantages single-use plastics have provided during this crisis. She commented: “Single-use items reduce exposure by eliminating the need for personnel to collect, wash and disinfect everyday items as well as medical-specific ones.” Bradley added: “Plastic bags and packaging protect workers who allow us to do social distancing such as grocery and delivery workers, as well as those of us receiving deliveries. Most importantly during a crisis like this, single-use items allow frontline workers to focus on treating the sick and eradicating the virus instead of worrying about the cleanliness of the tools they use.”

Josh Blackmore, global healthcare manager for thermoplastic resins distributor M. Holland also expressed the importance of singleuse plastics to tackle Covid-19: “There has been a huge spike in single-use disposable applications, which are driving a tight market as producers scramble to make masks, gowns, diagnostic test kits and other disposables.”

Single-use plastics have, however, always played a key role in the medical sector. The use of this material not only reduces infection risk in gloves used in surgery for example, but

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also ensures devices and drugs haven’t been tampered with through packaging with seals.

The issues that exist around the use of this material are not because of a disagreement over the benefits it offers, but rather typically a concern over the effect of single-use plastics on our environment.

Of course, I think it’s fair to say that plastics waste problems are geographical. In the West the average per capita consumption of plastics is reportedly 60-90 kg, whereas in India this figure is thought to be as low as 10kg. Additionally, in India, plastic which is classed as ‘waste’ is often collected and used with virgin material to manufacture low-cost items.

It is also worth noting that even when plastic which is classed as ‘recyclable’ is used within the medical setting, issues often exist around how and where to recycle the plastic, and the costs associated with this to both the manufacturer and the user of the medical device.

Industry group, Plastic Recyclers Europe, has said that the effects of the pandemic could “render recycling unprofitable and hamper attainment of the EU recycling targets.”

The European Plastics Converters (EuPC) also called for the European Commission and member states to postpone the implementation of the EU’s 2019 SingleUse Plastics (SUP) directive. However, the response from Commission executive vice president Frans Timmermans, was that the crisis should not be used as an excuse to “undo things that need to be done anyway.”

As everyone makes steps to recycle and live a greener lifestyle, it is natural to think that single-use plastics are not the right material for use within the medical sector anymore.

However, what this pandemic has shown is that these materials do have an important role to play within the industry, and maybe we need to acknowledge this and find better ways to treat these plastics following their use.

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DIGITAL

MEDTECH UPDATE

spy MEDTECH UPDATE

www.idtechex.com

How AI is revolutionising medical diagnostics www.nature.com www.skyrora.com

Scientists claim a new enzyme can recycle plastic bottles within hours

R

esearchers working for Carbios, a firm based in France, have created an enzyme which breaks down plastic. The scientists believe the enzyme could eventually make plastics biodegradable.

The enzyme, PET hydrolase, is a bacterial enzyme which was found in a compost heap of leaves.

Although PET hydrolase can be recycled, parts of it may end up in landfill.

This enzyme can break down

plastic bottles into chemical parts, and then be used to manufacture other plastic bottles.

There are drawbacks, however, as PET bottles have to be processed, heated and ground-up before they can be broken down - which means an increased cost for the material.

It is hoped the enzyme will be produced on an industrial level by 2024. The research has been published in the journal Nature.

NEWS UPDATE

talkingadditive.com

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report published by market research company, IDTechEx, highlights how Artificial Intelligence (AI) offers a wide range of benefits to the medical diagnostics sector, including speeding up the referral process, freeing up expert resources, offering the best accuracy everywhere regardless of skill levels, and making the processes more widely available.

The report explains how as funding reaches start-up companies and research and development teams, more AI tools are being developed to detect and classify diseases based on data from sources such as ECG and CT scans.

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The reported results suggest that software can carry out these tasks “faster, cheaper, and often more accurately” than trained experts or professionals. This would allow experts to spend their time on more complex tasks which cannot be completed by AI-based automation.

Although challenges will need to be overcome before AI software is universally adopted, the benefits are promising.

The report is titled, “Digital Health & Artificial Intelligence 2020: Trends, Opportunities, and Outlook”.

3D PRINTING FIRM LAUNCHES PODCAST SERIES

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ltimaker has announced the launch of its new podcast series titled, “Talking Additive.”

The series which will be hosted by Matt Griffin, director of community development at Ultimaker, will feature guests from the company’s network of partners, customers, and allies. The episodes will aim to discuss the future of manufacturing, engineering and design through stories and shared experiences from innovators from all around the world.

Initially three podcasts were uploaded and shared, however,

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typically one episode will be released on a bi-weekly basis.

You can listen to the podcasts on the Talking Additive website, as well as on Spotify, Google Podcasts and Stitcher.

DIGITAL SPY

MEDTECH UPDATE

www.sciencedirect.com

Researchers develop 3D printed drug delivery system using a magnetic field

R

esearchers from the UK and US claim to have developed a 3D printed device with a controllable system for on-demand drug delivery via an integrated magnetic field.

This system was designed with the idea of creating a safe, long-term, and reusable method for localised disease treatment for indications like cancer.

According to the researchers, 3D printing technology was used because: “This technology can

achieve detailed and flexible spatial composition and provide more available starting materials (like colloidal inks, bio-inks, and polymers) for the unprecedented complex and precise manufacture of 3D drug delivery systems.”

talking

POINT

The research paper titled, “Novel 3D printed device with integrated macroscale magnetic field triggerable anti-cancer drug delivery system” has been published in the journal, Colloids and Surfaces B: Biointerfaces.

ec.europa.eu

EU MDR:

Where are we now?

Is the European Medical Device Regulation (EU MDR) still set to take effect on May 26th, 2020?

No. To allow manufacturers and medtech companies time to focus on tackling the Covid-19 pandemic, the implementation date of this regulation has been delayed.

NEWS UPDATE

www.polarismarketresearch.com

PPE market forecast to reach USD 81.35 billion by 2026

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new study published by Polaris Market Research has announced this figure, alongside a predicted Compound Annual Growth Rate (CAGR) of 7.8% from 2020 to 2026.

The reasons for the rise in demand for Personal Protective Equipment (PPE) are thought to be because employers are becoming increasingly aware of the need to protect the safety of their employees.

The use of PPE is particularly necessary within the manufacturing sector, where guidelines have been enforced by regulatory bodies in order to promote the health and safety of the workforce.

In 2017, the largest share of the PPE market was thought to be in the North American region, and in terms of protective clothing, professional footwear is anticipated to experience the highest growth due to its use across multiple industries.

With the coronavirus pandemic, there will have been a surge in demand for PPE all around the world.

When will EU MDR come into effect?

The date has been postponed by one year and will now come into effect on 26th May 2021.

When was this delay officially decided?

Organisations such as MedTech Europe were calling on the European Commission to consider the delay due to multiple reasons, but mainly the pandemic. The European Commission voted on delaying EU MDR and it received an outstanding 693-0 to adopt the amendment. Following this vote the delay was made official, with the publication of an amendment in the Official Journal of the European Union on 24th April, 2020.

What does this mean for manufacturers?

It will allow manufacturers to prioritise supplying safe and well-performing devices to patients, healthcare professionals, and healthcare systems on the frontline during the Covid-19 pandemic. There will also be additional time for more notified bodies to become designated and operational under the MDR. Is the In Vitro Diagnostic Regulation (IVDR) delayed as well?

No. Currently, the IVDR is still set to take effect on 26th May 2022. A decision MedTech Europe believes “needs to be adapted by at least 12 months, both to address today’s reality and to prevent unintended fall out in the future.”

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NEWS ANALYSIS

A LOOK AT WHY THE MANUFACTURING SECTOR IS STILL LARGELY MALE DOMINATED, THE CONSEQUENCES OF THIS, AND THE POTENTIAL BARRIERS WOMEN WITHIN THE INDUSTRY ARE EXPERIENCING.

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he Irish Medtech Association recently published a document titled, ‘Inspiring girls, supporting female leaders’. The report aims to identify case studies where successful policies are displayed for manufacturers to see and understand.

Following the publication of this report, MPN editor Laura Hughes, spoke to Rebecca Luce, president of American Swiss Products, to discuss her background, women within medtech, and some of the findings from this published report.

In her welcome note, Sinead Koegh, Ibec medtech and engineering director, explains how women are often affected by “unconscious bias”. Keogh highlights how women represent 50% of higher education graduates, yet often lack the confidence to succeed, as well as struggling to battle through the many other barriers which exist for women in the workplace. She also mentions how gender diversity is often not thought of as a priority for men as they are unable to understand the difficulties women face, and even when companies claim to be committed to diversity, only half of them are actually making real progress.

Manufacturing is still considered a men’s world.

LH: PLEASE TELL US IN BRIEF ABOUT YOUR BACKGROUND. RL: I am a 3rd generation salesperson. I came to American Swiss in April 1995. My strengths are an analytical mind while being personable and knowledgeable without being patronising. It is a delicate thing to tell a man in manufacturing that his way is inefficient or that there is a better way.

American Swiss has always been very progressive in the role of women in the workplace, and women have served as comptrollers, sales and VPs. LH: WOMEN ONLY MADE UP 29% OF THE WORKFORCE IN MANUFACTURING IN THE US IN 2016. WHY DO YOU THINK THIS IS? RL: Manufacturing is still considered a men’s world. I was at a supplier summit for a major sensor company, and one of my competitors suggested that I should get the coffee for everyone as I was the only woman present. While the customer looked anxious, I just laughed and said I don’t drink coffee, but I would love it if he got me a diet coke. There is certainly a way to be strong without coming off masculine or aggressive. As far as manufacturing, it tends to require some very decisive outcomes. Women tend to be more collaborative and that style of management will get in the way of the quick decisions needed in manufacturing.

I still think the schools are failing at encouraging women to be technical. With the recent Covid-19 crisis and our lag time in manufacturing critical items, I think we may see a resurgence of machining in the USA, and perhaps a greater focus of education - especially of women. There is a shortage of skilled workers and we leave 51% of the working population untapped.

LH: AMONG THOSE WITH AMBITIONS TO REACH AN EXECUTIVE LEADERSHIP POSITION, ONLY 58% OF WOMEN WERE CONFIDENT THEY’D SUCCEED VERSUS 76% OF MEN. WHAT DO YOU THINK ARE THE MAIN REASONS FOR THIS? RL: To be successful, you have to have a certain personality. Executives tend to be ambitious and somewhat single minded. Men don’t tend to be worried about feelings while women are frequently concerned with how something is presented. Schools and colleges need to focus on leadership programmes.

LH: WHAT DO YOU THINK HAS CHANGED IN ORDER FOR FEMALE PARTICIPATION RATES WITHIN MEDTECH, AS WELL AS MANAGEMENT TO RISE? RL: We are starting to see some very exciting programmes in STEM and more women professional networks like Women in Manufacturing groups.

LH: IN 2019, FOR THE FIRST TIME IN HISTORY, MORE FEMALE STUDENTS TOOK SCIENCE A LEVELS COMPARED TO MALE STUDENTS IN THE UNITED KINGDOM. WHAT IMPACT DO YOU THINK THIS WILL HAVE ON THE SECTOR? RL: I think this will have an amazing impact. Women are more readily able to accept input and I think we will have a more collaborative design. I am hoping with a more diverse design team, we will see the errors in a design before we build. This should lead to less product recalls and a more robust and profitable business model. There may be an ability to have more cross functional teams rather than the traditional corporate hierarchy.

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ORTHOPAEDICS

Therapy FOCUS Moving forward DANE WAUND, GLOBAL MARKETING MANAGER – HEALTHCARE, AND SOPHIA SONG, MARKETING AND E-COMMERCE MANAGER, BUSINESS INCUBATION – ADDITIVE MANUFACTURING, BOTH FROM SOLVAY SPECIALTY POLYMERS, EXPLAINS WHY CUSTOMISATION AND SPEED ARE TOP ADDITIVE MANUFACTURING BENEFITS FOR ORTHOPAEDICS.

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he American College of Surgeons has called for hospitals to “minimise, postpone or even cancel” elective procedures until the coronavirus (Covid-19) outbreak slows down. Hospitals and surgical centres are beginning to embrace this idea as a way to effectively deal with the impact of this unprecedented global pandemic on society. This response may significantly affect the orthopaedic surgery community and its suppliers, as many orthopaedic procedures are considered elective. However, it is likely too soon to fully understand the impact this crisis will ultimately have on the orthopaedics market. Despite this situation, device manufacturers still need to explore new, inventive, and cost-effective ways to continue moving the industry forward.

One such opportunity is to drive innovation and improve medical outcomes with additive manufacturing of surgical instruments and implants using thermoplastics. The two methods - Fused Filament Fabrication (FFF) and Selective Laser Sintering (SLS), offer complementary approaches. The first is ideal for low volume, customised parts with complex geometries that can be produced at or close to the point of care. The second lends itself to centralised production of higher-volume components with complex geometries. Together, these technologies offer the orthopaedic industry the proven advantages of polymers over traditional metal (lighter weight, high-performance properties, support for bone ingrowth) plus the unique capabilities of additive manufacturing, including patient/surgeon personalisation and production of complex designs.

PRINTING SURGICAL INSTRUMENTS Additive manufacturing of orthopaedic components offers the ability to move beyond standard designs to provide instruments that are customised to the surgeon, the procedure, and/or the patient. Templates, guides and

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fixtures can potentially be designed and printed at or near the point of care using small FFF printers. These machines build a part in layers through the deposition of heated, extruded plastic filament.

In SLS, a laser heats a powdered material to just above its melting point, bonding it to create a 3D structure. SLS equipment typically can print multiple components simultaneously, making it a good choice for producing complex instruments when intermediate volumes are required, such as for orthopaedic trials.

Using specialty polymers, alone or with metal for these applications, allows manufacturers to reduce the overall weight of individual instruments as well as the total set weight of surgical trays. These materials also enable improved ergonomics to reduce surgeon fatigue and build in functionality through part consolidation for enhanced designs and faster production.

High-performance thermoplastics such as PolyEther Ether Ketone (PEEK) and PolyPhenylSUlfone (PPSU) deliver unique properties including high strength and stiffness, resistance to aggressive medical disinfectants and cleaning agents, and part stability under repeat steam autoclaving. Although these specialty polymers can be more expensive than some metals on a bulk basis, additive (vs. subtractive) manufacturing minimises material waste, often yielding cost reductions.

PRINTING ORTHOPAEDIC IMPLANTS While metals such as titanium and cobalt chrome continue to be widely used in orthopaedic implants, specialty thermoplastics offer several advantages over metal. PEEK is particularly suitable for load-bearing applications due to its outstanding fatigue or repeat loading performance. Unlike metal, PEEK is similar to cortical bone in terms of density, stiffness and weight.

PolyLactic Acid (PLA) and related chemistries, in combination with a ceramic, are being used to replace titanium screws in knee ligament surgery. The PLA compound is bioresorbable, avoiding the need to remove the metal screws in a second procedure.

Using additive manufacturing to create thermoplastic implants offers further benefits. Intricate new implant designs can be created to optimise osseointegration - permanent fixation of the implant via bone ongrowth and ingrowth without fibrous tissue interference at the implant/bone interface.

ADVANCED MATERIALS FOR ADDITIVE MANUFACTURING To take full advantage of additive manufacturing methods, the healthcare industry requires specialised thermoplastics in the form of filaments and powders. Solvay’s high-performance medical-grade KetaSpire PEEK and Radel PPSU filaments are designed for printing limited-exposure applications (having less than 24 hours contact with bodily fluids and tissue) such as surgical instruments and devices, including cutting guides and personalised surgical instruments.

To support these products, Solvay offers comprehensive regulatory resources, including ISO 10993 limited contact testing with Master Access File (MAF) support. Global regulatory specialists can assist with medical device submissions and data requests.

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DIGITAL HEALTH

KEVIN DEANE, VICE-PRESIDENT, INNOVATION, PHILLIPS-MEDISIZE, DESCRIBES HOW A CONNECTED DIGITAL HEALTH PLATFORM PAVES A PROMISING PATHWAY.

Paving the way

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igitally enabled connected health solutions are becoming more prevalent in helping companies to monitor, measure, and support patient adherence to prescribed medications. Integrating connectivity into drug delivery devices offers promising opportunities for medical plastics manufacturers to consider how they might align with the drive to improve the patient and provider experience, support medication adherence, and share data across multiple touchpoints.

Today’s connected health ecosystem includes three key components: Connected devices (e.g. drug delivery devices), digital interfaces (e.g. patient and caregiver apps), and a cloud platform which enables data integration with multiple sources (e.g.

EHRs, IoT sensors).

We’ve developed an integrated technology platform that combines plastic components, electronic components, sensor technologies and associated software to create a flexible and scalable solution that can meet the healthcare industry’s needs around connectivity. Basing development of connected medical devices on these platform technologies provides the opportunity to use proven designs and established, repeatable manufacturing processes.

This enables manufacturers to utilise existing infrastructure and facilities to continuously produce the core product across multiple customers, and also to design custom features that meet unique applications.

BENEFITS OF A CONNECTED HEALTH PLATFORM Building solutions on a connected health platform provides many benefits for healthcare stakeholders, and for medical plastics manufacturers, this is an opportunity to provide additional capabilities and services. These benefits include the ability to share information (from digitally connected drug delivery devices) and analytics across pharma companies, clinical researchers, providers, patients and payers, to provide insight into how patients are taking their medication.

Low-cost, high speed deployment is another key advantage. It’s important to partner with a manufacturer who can deliver connected health solutions with electronics and sensors already embedded. This speeds the development process and keeps costs low, for both reusable and disposable drug delivery devices.

Embedding electronics and connectivity into medical devices can help address these goals, as well as make such devices more suitable for reuse. For medical manufacturers, this offers an opportunity to reduce part count, in turn potentially decreasing the complexity of the plastic moulding manufacturing and assembly operations and hence accelerating time to market. For plastic manufacturers, this might reduce production volumes and provide a route to a higher margin business, better alignment with customer needs, and an opportunity to offer new services such as the ability to integrate electronics, or in our case, to offer data services.

Building infrastructure for a connected health solution on a flexible, scalable platform versus starting from scratch for each new device makes it more cost efficient to add or refine infrastructure for future projects. Because the price per user declines as the patient population increases, the costs for integrating connectivity for medications also decreases.

THE DESIGN The upfront design is, in itself, another critical success factor in manufacturing medical plastic components that are part of a digital health solution. The right initial design is essential to accurately and efficiently completing all downstream activities that qualify or validate the process.

The best way to tackle the initial design and concepting phase is to start by seeking input from a wide range of stakeholders in the earliest stages of connected medical device development. This allows everyone to work with front-end innovators to define the concepts that deliver the best features and usability for patients, caregivers and healthcare professionals, as well as to identify the manufacturing and commercial realities that will contribute to the product’s success in the marketplace.

Because device manufacturers’ needs are typically built more around business requirements, they should strike a balance between design features and the cost of goods, length of use, production time and manufacturing complexity.

Ultimately, the product must be developed at a cost point, scale and level of reliability that will generate return on investment, yet still ensure a positive user experience.

CONCLUSION In the end, medical plastics manufacturers who help their customers to create medical devices designed with the patient first and built on a scalable, connected health platform, can embrace the power of a digitally connected future, improve adherence, and facilitate better outcomes.

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ADVERTORIAL

HOW PROCESS MONITORING AND MEASUREMENT SOLUTIONS FROM KISTLER ENHANCE MEDICAL DEVICE MANUFACTURING EFFECTIVE PAINKILLERS FOR MEDICAL DEVICE MANUFACTURING Pain isn’t reserved for patients – medical device manufacturers also feel it from time to time. The ever-rising demands for process stability and validation, for quality assurance and documentation often cause their fair share of aches and pains, not to mention added cost pressures. Kistler is working to relieve these pain points by offering a wide range of solutions along the entire value chain. From micro-moulding/injection moulding, assembly and joining systems, to testing and quality assurance – Kistler provides support for each step in the production process, together with added value for its customers.

Medical device manufacturers now face a number of challenges.

While regulatory requirements and customer expectations regarding quality assurance, transparency, traceability and documentation are on the rise, parts are becoming more complex and prices are declining. Accordingly, manufacturers have two major goals: To apply the highest quality standard at each stage of manufacturing in order to achieve zero defect production – and reduce their operating costs.

Kistler’s portfolio for medical device manufacturers combines intelligent, modular process monitoring systems, miniature pressure, force and torque sensors, and digital tools for enhanced connectivity.

FROM MONITORING TO OPTIMISATION With ComoNeo, the process monitoring system for injection moulding, manufacturers of moulded parts can integrate quality assurance into each production step, even for multi-component injection moulding. The system’s functionality is based on the measurement of pressure and temperature values inside the injection moulds. Cavity pressure is a parameter used to directly determine part quality, as its gradient in a moulding precisely reflects the conditions during the injection process. Thanks to the unique ComoNeoPREDICT feature, users receive reliable data on the characteristics of each component in advance, on the basis of the current cavity pressure profile. This information helps to reliably avoid scrap as well as pseudoscrap, and to fine-tune machine settings in order to maximise quality, reduce set-up time and improve process stability. ComoNeo offers several features to boost productivity as well as process transparency and safety in injection moulding.

In turn, the maXYmos process monitoring system helps improve the production quality of medical devices during joining and The new maXYmos TL ML process monitoring system for assembly and testing processes is ideal for small measurement ranges and is FDA and MDR compliant.

The process monitoring system ComoNeo for injection moulding includes several features to optimise process transparency and stability, e.g. online quality prediction for each part being produced.

assembly processes and in testing procedures. Sensors from Kistler are integrated into the production line and measure relevant parameters such as pressure, force, displacement and torque via curve evaluation during the process. Thanks to this information, additional quality tests can be significantly reduced or even omitted entirely. The data can be gathered, processed, selected and transferred to any data layer in need of information.

Further advantages: Different data streams can be combined, and unprocessed measurement values can be transferred to the production quality management database via Ethernet. As this database needs to be validated anyway, the validation process becomes substantially shorter. The newly launched maXYmos TL ML is ideal for small measurement ranges. Functions like multipoint calibration and tare of dynamic influences to the measured values increase accuracy immensely, especially with high dynamic processes. As all setting changes are recorded with time and user indices, the system is audit trail and user management compliant with FDA and MDR regulations.

ADDED VALUE FROM A SINGLE SOURCE Both ComoNeo and maXYmos feature an intuitive user interface, helping operators determine or adjust machine settings quickly and efficiently. The sensors from Kistler are available in an unprecedented range of sizes, including miniature formats, and can measure directly, indirectly or contact-free, allowing them to deliver high-precision readings, even in difficult measurement positions.

The sensors can be flexibly integrated throughout the production chain according to customers’ specific needs.

PORTFOLIO FOR MEDICAL DEVICE MANUFACTURERS FROM KISTLER

• A wide range of highly sensitive, small, and extremely robust piezoelectric sensors • Process monitoring system ComoNeo for injection moulding with several features for increased process transparency and stability offering OPC UA based data exchange • Process monitoring system maXYmos for assembly and joining processes, offering OPC UA interface, and the latest addition, maXYmos TL ML, offers additionally FDA and MDR compliance • Digital tools for enhanced connectivity, e.g. the digital charge amplifier 5074A • Extremely robust connecting cable (1900A23A) for highly dynamic applications in machine environments, designed to withstand at least 10 million bending cycles

www.kistler.com WWW.MEDICALPLASTICSNEWS.COM

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COVER STORY

MPN SPOKE TO AARON JOHNSON, VP OF MARKETING AND CUSTOMER STRATEGY AT ACCUMOLD, TO FIND OUT MORE ABOUT RISK MITIGATION IN MICRO MOULDING. CAN YOU EXPLAIN HOW IMPORTANT VERTICAL INTEGRATION IS WHEN LOOKING AT RISK MITIGATION IN MICRO MOULDING? There are many phases in a product development process for micro plastic parts and components, and it takes a co-ordinated team of experts in design, materials, tooling, moulding, validation, and assembly to successfully manufacture customer parts at volume. When working in a micro manufacturing environment when tolerances are measured in microns, it is critical that all involved in the product development process maintain an obsessive focus on mitigating the risk of non-adherence to these tight tolerances, and it is hugely advantageous that all team members are under one roof.

Having each department in one place eliminates issues associated with outsourcing any part of the product development process, as achieving micron tolerances requires control, and you can only really control what you undertake yourself. In addition, it allows, for example, the tooling manager or production manager to be engaged early in the product development cycle, helping to avoid having to go back to the drawing board with designs, having to review and change manufacturing processes, and having to recut already extremely expensive and time-consuming to make micro tools.

Success can only be achieved when a micro moulder has the experience and aptitude to think out of the box.

IS IT TRUE TO SAY THAT OF ALL THE ELEMENTS OF THE PRODUCT DEVELOPMENT PROCESS, MICRO TOOL FABRICATION IS PERHAPS THE MOST CRITICAL FOR MICRO MOULDING? The simple answer here is yes, and yes again! Without a good micro tool, you will not be able to make millions of end-use products repeatably and with the micron features required. Also, a poorly fabricated micro tool could eat up all your tolerance slack for the design to manufacture process in one hit. So, it is important that at the tooling end, the technology for fabrication is used that means you are well within the overall tolerance levels, so that there is some margin as the product development process progresses.

Micro moulders need to have at their fingertips an array of technologies that enhance the accuracy of a micro tool, often needing to employ wire EDM and extremely accurate milling machines. But optimising the tool begins before fabrication, and success is achieved by an experienced micro moulder ensuring that tool design and fabrication engineers work together to ensure successful outcomes where the watch words are “ultra-precision” and “right first time.”

AFTER TOOLING THERE OBVIOUSLY COMES THE MICRO MOULDING PROCESS. I SUPPOSE IT IS FAIR TO SAY THAT THIS IS NOT JUST NORMAL MOULDING BUT SMALLER? Yes, you could say that. Many people say that moulding on the macro level is a science and moulding on the micro level is an “art” and a science. This is

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COVER STORY

absolutely true, and again plays to the fact that success can only be achieved when a micro moulder has the experience and aptitude to think out of the box and be creative in any given micro moulding scenario. When micro moulding, and when being constantly pushed to manufacture tinier and tinier parts with more and more exacting features, the “art” comes from knowing where and when you can push the limits of micro moulding. This is where years of experience is critical, rather than just relying on numbers on a data sheet or flow analysis.

These variables are numerous, but include such things as residence time, injection pressure, mould temperature, etc. An experienced micro moulder will manually dial in such variables to optimise the moulding process for the specific material and geometric complexity of any given application, and by doing so will be able to keep a lid on tolerance slippage.

Quite obviously, once again, this part of the process also exemplifies the key role of micro tooling in the tolerance attainment equation. Whatever adjustments and fine tuning a micro moulder will make to optimise outcomes from the micro moulding process per se, ultimately the end result is that high pressure molten plastic will be injected into a tiny cavity, often containing extremely fragile core pins that can obviously deflect or break. The tooling must be able to stand up to this, or all the expertise from the micro moulder will be lost.

YOU HAVE TOUCHED UPON THE KEY AREAS WHERE CONTROL OF TOLERANCES IS FUNDAMENTAL. WHAT ELSE DO YOU NEED TO KEEP AN EYE ON? There are numerous other factors that require attention such as material variations that can lead to differential results when moulded, and environmental issues such as humidity and temperature that can alter the dimensional characteristics of end-use parts. All considerations, however, lead to the same conclusion: Success requires that a micro moulder is vastly experienced and vertically integrated.

WE ARE USED TO THE PHRASE, ‘IF YOU CANNOT MEASURE IT YOU CANNOT MAKE IT’. HOW IMPORTANT IS VALIDATION AND METROLOGY IN RISK MITIGATION? Metrology has a key role to play in any micro moulding product development process, and it is vital to use measuring technologies that are able to validate end-use products with feature sizes that are always extremely tiny. Without being able to do so, it is impossible to show that a product conforms to design intent and is therefore fit for purpose. So, saying that, micro moulders need to be equipped with state-of-the-art metrology tools and adhere to strict measurement protocols.

With any measuring tool, there will always be an inherent variation in the measurement system used.

In a micro moulding scenario, it is hugely important to establish confidence in the accuracy and reliability of the chosen measurement system(s). While other sources of measurement variation exist, the two key sources are equipment variation (repeatability) and appraiser variation (reproducibility). Reducing Repeatability and Reproducibility (R&R) variation to the lowest amount possible, gives us confidence in detecting variation in the product being manufactured.

Evaluation of the measurement system in terms of gage R&R should be an important element of any continuous improvement activity, especially with micro moulding applications where any variation in the repeatability and reproducibility of the measurement could crucially eat into the low margins for error in terms of tolerance attainment.

WWW.MEDICALPLASTICSNEWS.COM

15

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REGULATORY UPDATE

WEB CONTENT EDITOR IAN BOLLAND DISCUSSED WITH ANGELA BROWN, DIRECTOR OF REGULATORY AFFAIRS AT ICON, WHAT MANUFACTURERS CAN LEARN FROM MEDICAL DEVICE REGULATION (MDR) PREPARATIONS, THE EFFECT IT WILL HAVE ON THE IN VITRO DIAGNOSTIC (IVD) LANDSCAPE, AND WHY PREPARATION IS THE KEY TO SUCCESS.

GOING THROUGH CHANGES

M

ost recently, the EU introduction of MDR has been postponed for one year to 26th May 2021 due to the global Covid-19 pandemic, and many manufacturers might be wondering if the In Vitro Diagnostic Regulation (IVDR) will also be delayed. Brown explained how the disruption of the present pandemic is being realised by the medical device industry, with IVD manufacturers being no exception to this.

Yet as global processes change in order to treat Covid-19, there is an overwhelming need for industry to provide the basics, including personal protective equipment, medical devices, and IVDs. Although these essentials are available, supply does not meet the immediate demand.

To specifically address Covid-19, the European Commission is allowing individual member states to temporarily permit access for products that have not met the required conformity assessments to apply the CE mark. These are temporary measures and are only valid during the pandemic.

Prior to the Covid-19 outbreak, Brown presented at the Outsourcing Clinical Trials meeting at Medical Devices Europe in Munich in February. Here, she covered the urgent need for manufacturers to contract with a notified body, prepare compliant documentation, and establish a process for post-market activities.

Brown felt that IVDR manufacturers were behind in terms of preparation, were struggling, and had a lot of work to do to bring their existing products that are already on the market into compliance. She said: “They may have documentation that’s either outdated or not up to the current standards to meet the new requirements or the better explained requirements stated in the IVDR that wasn’t there previously. Although IVD manufacturers had awareness of these requirements from the IVD Device, IVDR gives more clear and defined steps to complete the requirements.

“I feel they have all of the information they need to bring their technical documentation into compliance but they’re struggling because they just don’t know how to put it all together.”

Brown explained how she hopes to see an increase in the amount of IVD notified bodies and urges manufacturers to start working with one as soon as possible. Currently only 10% of products require notified body involvement prior to being brought to market, but this will rise to 90% under the new regulation. However, the Covid-19 stay-at-home orders directly impacts further designations of additional IVDR notified bodies by limiting the necessary faceto-face required audits.

Brown felt that IVD manufacturers should be working towards obtaining or co-ordinating with a notified body to set expectations and timelines as well as determining their EU product portfolio. These efforts should be completed with a sense of urgency as manufacturers may already be behind: “It’s a lot of work

they have to do. Many manufacturers have never had their documentation reviewed or audited by a regulatory agency in order to meet the market compliance requirements, so they are learning as they start working with their notified body.”

There’s a key difference for IVD manufacturers compared to those who prepared for MDR, as Brown explained they had the benefit of needing notified body involvement for most devices placed on the EU market, while IVD manufacturers haven’t since the majority of the products are selfdeclared.

In the worst case scenario, what are the consequences if manufacturers haven’t adequately prepared for IVDR’s implementation? “What we are anticipating is that notified bodies that are designated for the IVDR will be significantly reduced from the notified bodies that are available for IVDD,” Brown explains, “and there’s potential for products to be removed from the market.” This could lead to concerning knock-on effects.

Amid uncertainty and an everchanging regulatory landscape, Brown recommends that IVD manufacturers should continue with current plans to certify under IVDR according to the 26th May 2022 date.

Brown recommends that IVD manufacturers should continue with current plans to certify under IVDR according to the 26th May 2022 date.

WWW.MEDICALPLASTICSNEWS.COM

17

TUBING, CATHETERS AND STENTS

JOE ROWAN, PRESIDENT AND CEO FOR USA & EUROPE FOR MATERIALS SPECIALIST JUNOKSHA, DISCUSSES THE JOURNEY TOWARDS ‘INTELLIGENT CATHETERS.’

T

he journey towards ‘intelligent catheters’ is an important one.

In order to advance surgery, it is crucial to have smaller, more flexible and higher capacity catheters at your disposal. Solutions such as MultiFilar and Multi-Channel Transmission (MCT) represent a breakthrough in the design of medical device cables that take us one step closer on the journey to the next generation of these important devices.

MULTI-FILAR ACTIVE CATHETER SOLUTION Multi-Filar cables have a capacity of up to 60 power lines – depending on AWG size or pitch – and are designed to provide not only increased functionality but also more signals into formerly inaccessible areas of the body.

Using precision-engineered PTFE lamination technology, single strand configurations are joined into a Multi-Filar assembly that can be utilised in electrophysiology catheters for applying pacing and recording protocols from inside the heart, ablation and balloon ablation catheters for atrial fibrillation as well as cardiac mapping.

The Multi-Filar technique also allows for easier assembly of the signal or power wires into the final medical device, making the manufacturing process simpler and more costeffective.

MCT CABLES MCT cables are a further milestone towards intelligent catheters. MCT represents a significant improvement on existing twisted pair coaxial and flexible printed circuit technology and enables new data-rich signals to be utilised in therapies such as intracardiac echocardiogram, ultrasound endoscopy and IntraVascular UltraSound (IVUS).

Existing catheters use twisted pair coaxial constructs to support signals along the device. This established technology has driven advances in catheter design and facilitated the delivery of many essential interventional, intervascular diagnostics and therapies. However, both progress of miniaturisation and flexibility has been hampered by the standard coaxial approach which comprises a core conductor, insulation, and a shield wire.

Physics and electromagnetics have prevented the development of smaller cables and has inhibited catheter flexibility.

In contrast, the new MCT cable design uses a cluster of simple microwires that are individually insulated with an innovative shielding/grounding construct which employs flux cancellation, therefore increasing its signal capacity for a given size. Whilst the traditional catheter requires two coaxial cables to run in parallel carrying two individual signal streams, MCT enables multiples of four signals to be brought together in one cable - significantly increasing the signal capacity per unit diameter.

Early prototypes have achieved a 32% reduction in the size of the cable, a critical factor in the attainment of future procedures within narrower vessels.

The MCT approach also provides a greater degree of flexibility compared to the existing approaches which promises major advances in the scope of medical procedures, especially within endoscopy. Importantly, MCT addresses the mutually exclusive needs of small size and signal integrity simultaneously.

WHAT’S NEXT? Looking further forward into the future, the next steps will likely focus on improved imaging. One route for this is through equipping catheters with an optical fibre containing tiny “mirrors” that reflect light when it passes through.

When the fibre bends, sensors can detect any change of colour in the reflected light which provides information on the intensity and direction of the curvature1, thus enabling more precise navigation. A prototype of this system is due later this year.2 REFERENCES

1 https://vascularnews.com/new-catheter-navigation/ 2 https://www.mevis.fraunhofer.de/content/dam/mevis/Documents/ English/PressReleases/020719-precise-navigation-through-thevascular-system-intellicath-en.pdf

It’ sa

ll a

bo

ut

th e

The bond strength between the individual strands can be adjusted to maximise strength for challenging assembly conditions or optimised for difficult separation processes. Multi-

Filar configurations allow for joining dissimilar single strand alloys together in one package, which is perfectly suited for applications like thermocouples, micro-cables that need a high strength member for load bearing, or assembly operations and electrochemical process cells.

18

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TUBING, CATHETERS AND STENTS

HEKUMA, A HIGH PERFORMANCE AUTOMATION COMPANY THAT SPECIALISES IN THE ENVIRONMENT OF INJECTION MOULDING PROCESSES, DESCRIBES ITS NEW HEKUCATH PLATFORM.

A NEW PLATFORM

I

n recent years, the demand for catheters has grown significantly. This diagnostic and treatment instrument is used for a wide range of applications and its use is far from its limits. In order to be able to cope with these increasing volumes in the medical market, catheter manufacturers must continue to automate their work processes.

Hekuma has created a solution for production companies with its fully automated production line for single lumen catheters - the HEKUcath. Here, the manufacturer receives automation, an injection moulding machine, and mould from a single source.

MPN editor Laura Hughes spoke to Helmut Schmid, product manager/ deputy head of sales, Hekuma, about the sector.

HIGH QUANTITATIVE OUTPUT The HEKUcath system aims to ensure a high quantitative output is possible.

A prerequisite for this is that the take-out gripper can handle up to 16 cavities from the injection mould, and as a result, 16 catheters can be processed at once.

WHAT ARE THE CURRENT TRENDS? We see a trend towards fully automated production systems to ensure the quality of the products and higher output.

Another reason for high output is the optimised system availability, which can be achieved through very short mould open times of less than one second when using a horizontal injection moulding machine. To achieve this, Hekuma queried the mould position via additional displacement sensors on the machine clamping unit. The start signal for the entry movement is thus given earlier as it is triggered by the sensor.

WHY DO YOU THINK THERE IS A SURGE IN DEMAND WITHIN THE MEDICAL SECTOR? Catheters, tubing and stents are a form of minimally invasive medicine. The complication rate is therefore less than for other interventions. Another factor is the fast ageing population with increasing chronic diseases, which will be a driver for such medical devices.

MEETING QUALITY REQUIREMENTS Absolute precision and cleanliness are required in the manufacture of medical devices. The fewer contact points and the more precise the production, the lower the risk of contamination and later infections when using the catheter.

Therefore, the minimal intervention that is required by the operating staff benefits the quality of the medical device.

The HEKUcath solution has an integrated camera which means that the catheters are inspected “on-the-fly” 100% contact-free for injection moulding defects and tube length. Any parts which are inspected and classed as ‘bad’ are disposed of fully automatically.

FLEXIBILITY The design of the system aims to offer a great deal of flexibility so that it can be variably modified according to the manufacturer’s requirements and quickly converted. This allows the customer to determine the number of cavities, as well as the length and diameter of the catheter tubing that is suitable for them.

It is also possible to choose the lumen supply either from the roll or from the magazine. Additionally, various packaging modules can be integrated and there is the option of Unique Device Identification (UDI) to guarantee complete traceability of the production process.

CONCLUSION The entire production cell requires only a minimal footprint, so that the compact design offers the potential for savings in material, space, and therefore costs. The HEKUcath platform aims to meet all current market requirements for the processing of single lumen catheters and allows customised solutions.

HOW IS THE MARKET EVOLVING? According to the forecast and expectations from companies such as Teleflex, Abbott, and Cook Medical, the market will grow by four to six percent per year.

DO YOU THINK THERE WILL BE ANY MAJOR CHANGES WITHIN THE NEXT DECADE? There will be major changes in terms of the search for alternative and recyclable materials.

WHY ARE PLASTICS SO IMPORTANT IN THESE DEVICES? All of these parts are single use and disposable, and there is no other material available which can be produced easily and cheaply in the required amount. In the future, there will be more recyclable plastics.

19

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©2020 Teleflex Incorporated. All rights reserved. Teleflex, “Work With The Experts” and EPIC Medtec are trademarks or registered trademarks of Teleflex Incorporated in the U.S. and/or other countries.

MPN_adv_86x265mm_May20.indd 1

10/04/2020 13:50:13

TUBING, CATHETERS AND STENTS

DAN SANCHEZ, PRODUCT MANAGER FOR TRELLEBORG HEALTHCARE & MEDICAL, OUTLINES IMPORTANT FACTORS TO EVALUATE WHEN SPECIFYING SILICONE TUBING FOR MEDICAL DEVICES.

On

the

of barium added to the tube makes it visible within soft tissue, while still enabling the fluid to be viewed to verify flow.

INNOVATIVE EXTRUDED SHAPES AND ANTIMICROBIALS Kink-resistant and multilumen silicone tubing is invaluable in certain medical device designs. Several types of reinforcements, including some that are biocompatible, reduce a tube’s tendency to kink and stop the flow of fluid. This is especially important in implantable devices when fluid transport is critical, and the tube must remain open during bodily movement.

T

he global medical tubing segment continues to rise at a significant rate and is expected to reach USD 9.38 billion by 2022, according to MarketsandMarkets Research. Therefore, silicone is identified in terms of volume, as the largest and fastest growing material within the global medical tubing segment.

WHAT TO LOOK FOR One of the key mechanical considerations for silicone tubing is size, especially as medical device developers seek to produce ever-smaller devices and drug delivery systems. It is currently possible to produce implant-quality silicone tubing at the scale of 0.007 inch x 0.014 inch. However, not all suppliers are capable of doing so reliably and at the speed necessary to deliver products to market in a timely manner.

Another consideration is hardness. Generally speaking, extruded silicone is available in durometers from Shore A 20 to Shore A 80. As the durometer increases, tensile strength decreases. This is therefore an important factor to evaluate for devices such as wound drains, which are put under significant pressure when removed from the body.

Two other mechanical factors to consider are tear strength and elongation.

Tear strength influences, for example, how difficult it is for a nick in the tube to grow. This is something to consider in situations where the tube might be exposed to a sharp edge. Elongation properties relate to how stretchy the tube is, which is a significant factor for balloon devices.

Finally, the surface finish of the tube must be carefully evaluated. Quite often, when it’s important for a tube to have minimal surface friction, the tube can be coated to decrease the silicone’s inherent “stickiness.” However, the coating must be biocompatible if it is likely to come into contact with the body.

Tool design and processing parameters such as extrusion pressure, can also positively influence the surface texture of the final tube.

MANAGING VOLATILES AND TRANSPARENCY While highly biocompatible, silicone grades and additives must be considered based on the application. In cases where there’s a high degree of concern, leachable testing and post-cure processing, in which tubing is heated to +350 ºF, may be undertaken.

Visibility is important for certain types of devices, such as those carrying fluids into or out of the body. Although silicone is naturally translucent, certain silica fillers that increase durometer can reduce or eliminate transparency. A stripe

Similarly, when wires are insulated within a silicone tube and are subjected to repeat dynamic loading, such as where a cardiac pacing lead connects to the pacemaker housing, designers can consider multilumen tubing produced with a continuous twist to minimise strain hardening, reducing the probability of or eliminating wire breakage.

Finally, silicone’s inherent permeability can be leveraged to control the release of additives. For example, an antimicrobial ingredient added to a catheter reduces the risk of infection, and an anti-inflammatory ingredient in a pacemaker lead aids healing after insertion.

SUMMARY As the medical tubing market continues to grow, designers should consider mechanical properties, surface finish, biocompatibility, permeability, and advanced extrusion capabilities when assessing product requirements and supplier partners.

Innovation, engineering, and manufacturing advice provided by a well-chosen supplier, can help achieve a competitive edge by significantly improving the total cost of ownership, quality, and overall product performance.

Silicone is the largest and fastest growing material within the global medical tubing segment.

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21

3D PRINTING

the future is aut NIALL HASLAM, CTO FOR MEDICAL 3D PRINTING COMPANY, AXIAL3D, EXPLAINS THE IMPORTANT ROLES BOTH ARTIFICIAL INTELLIGENCE AND 3D PRINTING WILL PLAY WITHIN THE FUTURE OF THE MEDICAL SECTOR.

I

n most patient cases, a Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scan will provide a clinician with an acceptable level of insight to give them the confidence to define and proceed with a surgery plan. However, for over eight million complex procedures taking place each year, a 2D scan doesn’t always cut it for planning surgery and communicating your course of action to your patient.

SO, WHAT IS THE SOLUTION? A 3D anatomical model removes unnecessary variability from one surgeon’s anatomical interpretation from another - standardising the approach in interpreting the patient’s anatomical detail. The models can be held in the surgeon’s hands and fully scrutinised, allowing them to define and simulate a surgical plan before they set foot in the operating theatre reducing the risk to the patient.

The application of utilising 3D printing to create patient-specific models for pre-operative planning is still in its infancy. In fact, a Gartner study shows that only around three percent of hospitals and research institutions have 3D printing capabilities on site, with more hospitals adopting the technology each year. The recently installed 3D printing lab at Newcastle’s RVI is just one example, however, it’s clear there is work to be done in addressing this gap.

One of the reasons why the technology has not been more widely adopted, and often seen as being one of the largest bottlenecks in producing 3D printed anatomical models, is the availability of radiologists or biomedical engineers available to segment the 2D images. The segmentation process is the partitioning of an image into multiple labelled regions to locate objects and areas of interest in images. This can be an extremely time-consuming process and take clinicians away from treating patients for hours at a time.

Being able to utilise a 3D model and hold it in your hands prior to surgical intervention is very insightful for the patient – it helps them understand surgical interventional risks and benefits. 3D models have been shown to increase patient consent rates and aid in patient understanding of the planned procedure.

- Matthew Lawson, neurosurgeon and stroke medical director at Tallahassee Memorial Healthcare.

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W W W. M E D I C A L P L A S T I C S N E W S . C O M

tomatic MPN EDITOR LAURA HUGHES CAUGHT UP WITH AXIAL3D’S CTO NIALL HASLAM.

AUTOMATION IS ESSENTIAL If 3D printing is to become a go-to pre-surgical routine in healthcare, then automation is essential. Producing a 3D printable model from 2D images currently takes anywhere between four to ten hours per printed model. Axial3D is reducing this by building and using machine learning algorithms, allowing us to deliver nearinstantaneous results and removing the main bottlenecks associated with medical 3D printing.

We have developed an online ordering portal that allows surgeons to easily and quickly place orders to request a 3D printed model. The anonymised data is then given a unique identifier code and uploaded and managed on AWS Cloud, allowing us to deal with large volumes of medical images quickly and securely. All of this speeds up the process of producing and shipping the patient-specific 3D anatomical models to meet our delivery guarantee of 48 hours.

By applying machine learning to medical image segmentation, we have reduced our processing time to a few minutes. We are able to quickly deploy new models as they become available, facilitating rapid testing of new architectures and benchmarking performance of algorithms over time.

By leveraging the power of AWS, we have the capacity to process thousands of images simultaneously while creating cost and efficiency savings.

The use of machine learning has enabled us to provide a super-quick ‘DICOM to model’ service to clinicians wherever they are in the world, 24 hours a day, seven days a week, 365 days a year. The effect this has on patient care is game-changing. No longer will radiologists have to spend hours segmenting images to make them 3D-printable. No longer will surgeons need to wait weeks on a 3D printed model being produced and shipped. No longer will hospitals be expected to pay upwards of thousands of dollars for a single 3D printed model.

COULD YOU TELL ME A LITTLE BIT ABOUT YOUR BACKGROUND? My background is in helping clinicians and scientists understand biological data and integrate complex analytical tools. This helps them ask better questions and make better decisions about the care pathway for their patients.

I started off in genomics designing new methods of DNA sequencing identifying the limitations of the new technology platforms and understanding the resolution that they could provide. I’ve also been involved in the scale-up production of drugs and drug design, so I have a good understanding of the manufacturing challenges required for healthcare applications. Quality in the manufacturing sense is key to the service that we provide.

My background is an odd mix of manufacturing and software development in the medical sectors, therefore Axial3D is the perfect blend of this experience. We manufacture patient-specific anatomical models and use software to generate these designs. Increasingly, these days cutting edge technologies are converging so you need experience in multiple fields in order to succeed. We see that in the team at Axial3D. We have people from a wide range of backgrounds and each of them contributes something unique to the company.

HOW DOES AXIAL3D HELP MEDICAL PROFESSIONALS? We take MRI and CT scans and use machine learning to identify the anatomy within them. We then create a 3D printable version of the anatomy and print it for surgeons to help them plan operations more effectively and aid the patient consent process.

WHAT MADE YOU WANT TO WORK AT AXIAL3D? I wanted to get involved because it is a perfect blend of my interests and I get to help people. I love using computational models to understand biological problems (like identifying anatomy) and I love making things (printing that anatomy). There is something special about creating a tangible output and knowing that will be used to improve the standard of care for a patient.

WHY DO YOU THINK IT IS SUCH A POWERFUL IDEA? I hesitate to use the word synergy, but honestly it is the best suited to describe the power of Axial3D. We bring together a number of powerful technologies and use them to make 3D printing more accessible. By doing this we make 3D printing routine and ultimately unlock other potential technology platforms in the future.

WHERE DO YOU SEE AXIAL3D IN 5 YEARS’ TIME? We see 3D printed anatomical models being used routinely in complex operations and pre-operative planning. We are starting to see the evidence confirming the effectiveness of this approach and the impact it makes in clinical education and decision making. We will be recruiting more patients for these trials to expand the type of operation that can benefit from this technology in the near future.

In the long term, the algorithms we are developing will be used to reduce the barriers to accessing custom made implants from a biocompatible material.

We are doing some work in this area with Ulster University and other partners through the EU InterReg funded NW CAM project.

HOW CAN PEOPLE FIND OUT MORE ABOUT YOU AND YOUR WORK? We regularly present at meet-ups in Belfast and Dublin, as well as more technical conferences focused on artificial intelligence and 3D printing.

We are always open to collaboration and have worked with a number of other companies over the years on different aspects of our core and adjacent technologies.

If you are interested in working with us and there isn’t a role open, do reach out as we are always interested in potential opportunities. @Axial_3D @HaslamNiall

@axial_3d

23

Injectable Solution Bag

How Low Can You Go? Low leachables Low extractables Low hassle Low waste Low cost Traditional plastic containment systems are not ideal for liquid drug formulations.

They can introduce impurities into medications, which is why drugs are often stored as powders in glass vials. But this creates additional challenges. When nurses reconstitute at the patient’s bedside, there can be treatment delays, glass breakage and mixing mistakes.

The ZACROS NIp-Σ Bag is a novel container that addresses these challenges. It combines the flexibility of plastic with the stability of glass due to an innovative inner surface film that offers low leachables and extractables, making it the ideal container for biologics and other liquid-based medicines. It’s a true readyto-use bag that benefits drug companies, healthcare providers and patients.

Ready to go low? Learn more at www.zacrosamerica.com/products/medical-packaging ZACROS AMERICA, Inc.

220 Lake Drive Newark, Delaware 19702

Phone 1-800-890-1183 Email: CustomerService@zacrosamerica.com

EXTRACTABLES AND LEACHABLES

Back on track SANDI SCHAIBLE, SENIOR DIRECTOR OF ANALYTICAL CHEMISTRY AND REGULATORY TOXICOLOGY AT WUXI MEDICAL DEVICE TESTING, EXPLAINS HOW MANUFACTURERS CAN GAIN COMPLIANCE UNDER EU MEDICAL DEVICE REGULATION (MDR) AS QUICKLY AS POSSIBLE. WHO DO MANUFACTURERS NEED TO BRING TO THE TABLE IN THESE TESTING DISCUSSIONS, TO MAKE THE PLANNING PROCESS AS EFFICIENT AND EXPEDITIOUS AS POSSIBLE? A successful testing plan starts with the right team supporting it. With added pressure on the market, it’s essential to ensure your assembled team knows their products backwards and forwards. Ideally, this is a cross-functional team spanning marketing, research and development, operations, and quality.

Involving a knowledgeable and experienced product manager can help streamline the planning process. Other vital roles to engage during the planning process include design engineers who are familiar with the ins and outs of the product design and functionality, as well as manufacturing engineers, and potentially a production manager who can discuss the manufacturing process and any additives that may have come in contact with the product.

Your team should also consist of people knowledgeable on sterilisation, packaging, and labelling. Involving experts in these areas will help create a comprehensive product testing plan.

WHAT CAN MANUFACTURERS DO TO HELP STREAMLINE THE TESTING PROCESS WITH THEIR SELECTED TESTING LAB? Be communicative and bring all product information with you to the table you can never provide too much information to a testing lab. Collecting and assembling information is an essential first step, and the critical second step is sharing it. It may seem like a testing lab is asking for an excessive amount of information, but these details can make or break a testing plan. Time is of the essence, leaving no room for errors or missing information.

Some areas to be prepared to discuss about each device include: - Existing data from previous testing.

- Parts and composition.

- Materials, colourants, pigments, adhesives, additives, polymers and manufacturing aids.

- Size, thickness and surface area of the entire device, as well as the portions that come into contact with patients.

- Market, intended purpose, product category, use scenarios, and patient contact time.

- Manufacturing and sterilisation procedures.

characterisation studies. If you can’t hold a testing lab accountable to these levels, you may face backlogs in your testing plan. Don’t let your guard down - watch for regulation changes even after the deadline has arrived, and work with your selected testing labs who can also help you stay informed and up to date.

CONCLUSION If you’re facing pressure to get back on track with your compliance efforts, you’re not alone. Use this advice to reduce the risk of setbacks.

Reassessing your testing plans is the first step to getting your device approved as quickly as possible.

From having the best team in place to ensuring your testing partner has the necessary capabilities to support your success, do your due diligence to get yourself back on track for a successful submission.

If you’re facing pressure to get back on track with your compliance efforts, you’re not alone.

WHAT HURDLES SHOULD MANUFACTURERS BE AWARE OF WHILE DEVELOPING A TESTING PLAN? The two most significant hurdles manufacturers face in developing a testing plan have to do with legacy devices and regulatory knowledge. Legacy products that need supplemental testing before approval present unique obstacles of their own. To move forward with testing, manufacturers now must provide additional device information that was not previously required.

Staying up to date with regulatory requirements also continues to be a hurdle, as expectations are still evolving.

In the coming months, notified bodies will continue to gain experience enforcing standards and will likely begin to ask even tougher submission questions. Additionally, other governing bodies continue to release standards advancing the requirements with which manufacturers must comply. We’ve seen this with the update to ISO 10993-18, which enforces more stringent identification requirements for chemical 25

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PACKAGING

MPN EDITOR LAURA HUGHES CAUGHT UP WITH THOMAS BRAUN, MARKETING MANAGER FOR PACKAGING COMPANY ROSE PLASTIC, TO EXPLAIN WHY PLASTIC IS AN IDEAL OPTION FOR PACKAGING.

Number one WHAT ARE THE MAJOR CHALLENGES FOR PACKAGING MEDICAL IMPLANTS, AND HOW CAN THESE CHALLENGES BE OVERCOME? One major and continuing challenge for packaging medical implants is certainly the requirement to package implants safely and securely. That is, to not only protect them from mechanical damage and ensure that no abrasion occurs, but also to provide effective protection from dust, dirt, humidity and so on. While the safety of the implant has to be ensured, great usability is also a must.

These challenges can be overcome with intelligent product concepts like our implant packaging solutions, which combine easy and intuitive handling during surgery with great protection of the implant. They are also perfectly suited for well-organised storage with minimal space requirements.

WHAT ARE THE BIG TRENDS IN MEDICAL PACKAGING AT THE MOMENT? Of course, the mega trends in the packaging industry do not stop at medical packaging. The concepts of smart packaging, digitisation, and automation are always present and place high demands on the packaging of the future.

In addition, there is the demand for packaging solutions that can save both space and waste. With our packaging we are well prepared for these requirements and will continue to develop innovative packaging with valuable customer benefits in the future.

IN THE NEXT FEW YEARS, HOW DO YOU THINK THE PACKAGING OF MEDICAL DEVICES WILL CHANGE? There is a trend to use less material, reduce waste, and simultaneously improve product protection. Also, medical devices have to be packaged in ways that are easy to handle, save time, and add additional benefits such as easy coding or tracking. Rose plastic’s TubeInTube is a good example of an implant package that does more than just package a product.

It’s a package of benefits that meets our clients’ needs in improving the packaging of their quality products, thus adding value to their overall offering, helping them improve product image and quality, and generate more sales.

HOW HAS THE MANUFACTURING OF PLASTICS CHANGED OVER THE YEARS? Modern equipment and machinery, as well as more intelligent ways of producing plastic packaging based on years of experience and specialised knowledge in the field, have led to more efficient, stable processes and product quality. Rose plastic has not only been one of the original pioneers of protective plastic packaging, but has also been among the early advocates of total quality management since its introduction in the 80s. Since then, we’ve gone a long way by applying several kinds of production methods and working procedures that have helped us to become a specialist in high-quality protective packaging.

Overall, the way plastic packaging is produced and shipped today has little to do with how it was done 50 years ago.

Plastic is still one of the most economically and ecologically sound packaging solutions.

WHAT TYPES OF MATERIALS DO YOU BELIEVE ARE CURRENTLY THE PREFERRED OPTIONS FOR PACKAGING? Plastic, due to its many advantages, is still one of the most economically and ecologically sound packaging solutions. For example, its CO2 footprint is much better compared to practically all other kinds of packaging. Rose plastic is constantly exploring promising alternative ways to use renewable resources to produce even more environmentally friendly products in the future.

HOW DOES ROSE PLASTIC CUSTOMISE PRODUCTS? Based on sound knowledge and a deep understanding of customer needs, rose plastic is able to develop customised packaging solutions together with its clients. Our internal design and development department, our own tool shop, and other specialities make for a great combination of expert knowledge that enables us to carry out projects in a most economical, time-saving way, and come up with solutions that stand the test of time and are designed to meet the requirements of reality. Our customers value the way we support them and work with them on their often demanding projects, bringing our expert knowledge, experience, and project management skills to the table that help them achieve their goals faster and cheaper than they could do it on their own.

WWW.MEDICALPLASTICSNEWS.COM

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ALASTAIR COOK, PRODUCT MANAGER AT ULMA PACKAGING UK, EXPLORES THE BENEFITS OF THERMOFORMING TECHNOLOGY TO ENSURE THE HIGHEST SAFETY STANDARDS ARE UPHELD.

T

he medical industry requires fully reliable packaging that offers maximum possible protection for products designed to care for patients and preserve their health.

Consequently, packaging solutions in this sector must meet the strictest possible regulations.

These criteria include ISO 11607 for the packaging of medical products. This is extremely stringent, and frequently updated as part of ongoing efforts to protect product integrity and the safety of patients.

EXCEED STANDARDS Alongside adhering to ISO 11607:2019, further legislation has been introduced to heighten supply chain product safety. The European Union introduced the Falsified Medicines Directive (FMD) in February 2019, and the UK government has confirmed it will be in effect after Brexit.

Designed to improve protection and preserve tough sterilisation conditions, the legislation established two mandatory safety demands on packs of medical products. These include unique identifier barcodes to ensure full traceability, and tamper-evident features to assure patients their medicines have not been interfered with.

Many medical product manufacturers exceed the heightened scrutiny of current legislation to provide quality control assurance, achieving compliance with regulations such as Part 11 of Title 21 of the Code of Federal Regulations, otherwise known as Title 21 CFR Part 11, or Part 11 for short.

Though part of the USA’s Food and Drug Administration (FDA) regulations, some UK organisations have implemented practices set down in Part 11 to further bolster quality control.

Its criteria look to ensure electronic records in the healthcare, biotech and biologic fields can be considered as trustworthy as their equivalent paper records. This involves implementing controls like audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing electronic data.

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TRUSTING TECHNOLOGY APPLICATION OF REGULATIONS For medical manufacturers, practices from Part 11 are applied at the product packaging stage. By retaining important control system data, manufacturers can pinpoint metrics such as individual machine packaging cycles, cycle numbers, parameters monitored, and even machine operator identity.

This thoroughly forensic process reinforces quality control, allowing close evaluation of detailed machine data to better inform and ensure best possible practice. Again, while optional, Part 11 further highlights just how important the avoidance of spoiled products is in the medical sector.

So, when specifying appropriate product packaging solutions in the medical industry, it is vital the integrity of packaged medical devices remain uncompromised. Though factors that could induce product spoilage should be a concern regardless, maintaining contaminant-free packaging processes is paramount for medical manufacturers. Failure to adhere to safety protocol could result in impaired packaging processes, potential fines, reputational damage, and, most gravely, jeopardised consumer health.

BETTER MATERIALS Multiple materials can be used to package medical products, including plastic films, medical-grade paper, synthetic materials such as Tyvek flash spun high-density polyethylene, or aluminised materials, such as steel. Although they all protect packaged products, their effectiveness is amplified by how they are applied. Consequently, choosing appropriate machinery to eliminate the damage of products and maintain a sterile packaging barrier is of vital importance.

Of all the packaging technologies and lines available, thermoforming is most ideally suited to mass medical device packaging. Naturally versatile, robust and reliable - thermoform machines can use multiple rigid and flexible packaging materials to create dependable, protective packaging.

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PACKAGING

Medical manufacturers can enjoy peace of mind, knowing that all stages of the packaging process are being closely monitored to maintain the highest possible product standards. Furthermore, because of the modular design of thermoform machines, it is easier to add monitors to view the entire packaging line for heightened visibility and closer control of consistency at each stage of the process.

HOW THERMOFORMING WORKS Thermoform machines for the medical sector produce trays on a horizontal packaging line. This is done through the use of two film coils, which are usually composed of different rollstock materials. These differing materials are unwound from their respective reels and fed through a pre-heating station.

This station, which contains a lower and upper plate, softens the material to enhance its pliability.

As part of this process, the bottom film is heated and negatively formed into a cavity via the use of a vacuum or, on occasion, highly-filtered compressed air. The film is then cooled, making the plastic more rigid when it is removed from the mould. For difficult shapes such as blister packaging, where cavity shapes can exceed the size of small medical devices, a ‘plug assist’ feature partially pushes plastic into the cavity to create more even and uniform wall distribution.

After this cavity is created, the product is loaded into it using automated product filling. When the product is in place, the top film layer is then rolled over the mould and heated to create a hermetic, airtight seal between the product and the surrounding environment. This thermoforming fill seal process, which all takes place on the same piece of equipment, provides an extremely effective level of protection against external contaminants and the possibility of tampering. As well as being extremely durable, the high-quality seal also keeps the packaged product in place, minimising the risk of damage that can be incurred during transportation to distributors and finally the end user.

Following the sealing process, the packaging is cut into its final shape from a larger tray and ejected from the thermoform machine. These finished medical devices can then be sterilised through varying means, including steamheat treatments, radiation, or gases such as ethylene oxide. Crucially, these processes ensure contaminants are minimised without compromising the packaging integrity mandated by medical packaging manufacturers.

DATA-DRIVEN APPROACH Thermoform machinery provided by leading packaging machinery suppliers, such as ULMA, can also provide fixed and variable data printing and labelling, before or after sealing. To further ensure products are being packaged to the relevant standard, this can also occur before the cutting stages.

Examples of parameters that can be monitored are: Forming time, homogenous temperature across the packaging, and guaranteeing that the forming process remains at optimum temperature. If there is a deviation from the criteria specified by the standard or the manufacturer, any faulty product can be sealed and ejected from the packaging line without coding.

Overall, thermoform machines are extremely well-positioned to adhere to the rigorous demands required by legislation governing the medical sector. By investing in this packaging technology, the medical sector can continue to provide the best in product safety and consumer health satisfaction.

With medical manufacturers under constant pressure to safeguard products, the latest thermoforming technology offers an ideal protective packaging solution.

WWW.MEDICALPLASTICSNEWS.COM

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Plastic Solutions for the Global Life Science Industry • • • • • •

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JOHN D. GILL, AN ENGINEER FROM CAPLUGS, EXPLAINS FIVE THINGS MANUFACTURERS NEED TO CONSIDER WHEN DESIGNING PLASTIC PARTS.

I

njection moulding is the most common method of producing plastic components. When designing plastic parts, it is really important to understand what you can do in order to ensure the part can be manufactured as efficiently as possible.

A badly designed plastic part is difficult to produce, which means there may be quality issues with the part. As a result, this will mean it is expensive, both in the production of the part and the ongoing life of the part. The expense and difficulty can be avoided though by considering the following factors when designing the part.

Expense and difficulty can be avoided by considering the following factors when designing the part.

KEY DESIGN CONSIDERATIONS FOR PLASTIC PARTS 1 THICKNESS Plastic parts can have a much thinner wall thickness than most designers realise. A small cap approximately 1” (25mm) diameter can have a wall thickness of just 0.040” (1mm) and function well as a protection cap or plug.

5 TEXT Having a name or logo on the part is a great way to advertise or to provide the part number for the part. This is also easy to do on plastic parts. Generally, the text will need to be raised on the part and a final height of 0.020” (0.5mm) is a good height. Fonts such as Century Gothic, Verdana or Arial are recommended.

This thin wall means the parts can be produced quickly, maintain their shape and size during the production process, and have a short cycle time in the injection moulding machine. All of these elements ensure you receive a part that is consistently made to drawing and keeps production costs to a minimum.

2 UNIFORM THICKNESS

4 DRAFT

It is crucial to ensure that you design a part with a uniform thickness throughout. Parts with areas where the material is much thicker than the rest of the part are prone to becoming misshapen. If a plastic part cannot cool evenly at the same rate it is liable to become twisted or have areas that become dish shaped as they cool. All of this means that the dimensions of the part will not be consistent.

The part has to come out of the tool efficiently and cleanly, so it is important to add a draft angle to faces to allow the tool to eject the part efficiently. A draft on the part will ensure that you do not see deep ejector pin marks on the part or marks on the part where it has been forced out of the tool. As a general guideline, aim for one to two degrees of draft when designing the part. Don’t forget to maintain the wall thickness when adding the draft angle.

3 RADII Plastic has to flow in and around the tool in order to produce the part, so it is crucial to include a radius on every sharp corner. Where you have a corner in the design, make the internal radius approximately half the wall thickness and ensure the outside radius is one and a half times the wall thickness, in order to maintain a consistent wall thickness around the corner.

A plastic injection moulding company who designs their own tools will be able to help you with the design of your part, but thinking about the elements mentioned above will help both you and the company to get off to a smart start.

WWW.MEDICALPLASTICSNEWS.COM

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INJECTION MOULDING

NIGEL FLOWERS, MANAGING DIRECTOR AT SUMITOMO (SHI) DEMAG UK, EXPLAINS HOW VALIDATIONS CAN HELP TO DE-RISK PROJECTS, AVOID COSTLY PRODUCT RECALLS, AND COSMETIC PRODUCT DEFECTS.

VALIDATION: The process T

he validation rules, amended in 2015 by the European Commission, continue to apply today. From a UK perspective, it is highly likely that these EU standards will continue to be accepted until UK standards have been developed. CE marking is a case in point and will be accepted for the foreseeable future.

Governed by EudraLex Good Manufacturing Practice (GMP) Volume 4, the latest version of Annex 15 - Qualification and Validation - requires manufacturers to ensure that “critical aspects” of their operation are validated throughout the product lifecycle. This includes any changes that could impact a product’s quality. Closely mirroring the FDA’s lifecycle approach, Annex 15 also places a greater emphasis on risk management to reflect today’s manufacturing and regulatory environment.

For any manufacturer of pharmaceutical components, zero defects remain the target. For example, when producing a medical device or a sterile implant, nothing less than 100% quality is acceptable.

MORE THAN GOOD BUSINESS PRACTICE From a moulder’s perspective, validations can address profit-driven challenges and design out production weaknesses. Functional tests can help operatives better understand what drives the machine, how fast it goes, and the consequences if manufacturing procedures are not correctly followed.

There are three key phases to process validation, categorised as process design, process qualification, and continued process verification. These reflect the focus on the manufacturing lifecycle, and the need to provide scientifically sound data to verify that the injection moulding processes start and continue to remain stable. Every stage of each injection moulding cycle must be documented.

In accordance with ISO 13485 standards, ongoing documentation of the injection moulding process needs to be maintained. This is a continuous process. When machine settings are adjusted to compensate for changes in the environment or to address moulding issues e.g. pulling, distortion,

Validations can address profit-driven challenges and design out production weaknesses.

or aesthetic defects, it will trigger a re-validation exercise. So too would major repairs, changes, or improvements to the mould tool and machine. The cost and time implications each time a moulder repeats this validation process can be extensive.

Although not a prerequisite for all sectors, validation is essential within the pharmaceutical industry and is a good business practice for a large number of mass manufacturers of injection moulded medical components. Think of it as a longterm investment. Essentially, it’s a risk assessment which, when executed professionally, can deliver efficiency gains and save your business time, money and resources by ensuring product integrity and reducing scrap volumes.

WHO PERFORMS MOULD TOOL VALIDATIONS? The process is usually conducted by an engineer, and the actual validation usually takes longer than actually building the tool itself. For this reason, the validation is often partially completed at the toolmakers’ facility by a senior engineer from the company. The key reason for this is issues can be addressed on site, rather than shipping a heavy tool back and forth. The final phases of the validation will be completed in-house on the specified equipment.

It can also be beneficial for injection moulders considering new machinery to test moulding tools in a simulated application centre. Sumitomo (SHI) Demag has facilities in England and Germany, and recently opened a new medical test cell in a new research and development hub in Ireland.

Flowers concluded: “Seeing how an application performs in realistic process conditions not only helps moulders to make a more informed investment decision, it can also help to de-risk and speed up the delivery of projects.”

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Fitbit launches the virtual study ‘Fitbit Heart Study’ 1

The study will look at how the technology can identify irregular heart rhythm that could signal atrial fibrillation.

2

Trial participants must live in America, be at least 22 years old, and currently use a Fitbit device that tracks heart rate.

3

Atrial fibrillation is important to identify as it is the most common type of irregular heartbeat, and a significant risk factor for stroke.

06:2020 WEARABLE SMART PATCH OFFERS POTENTIAL FOR THE MEDICAL SECTOR

T

he patch will deliver precision data to help users personalise their diets, and as a result, reduce the risk of developing lifestyle-related chronic diseases like type 2 diabetes.

The device, which was developed by Australian start-up, Nutromics, is able to measure key dietary biomarkers and send this information to an app. This allows users to track how their bodies are responding to certain foods.

Nutromics co-CEO Peter Vranes, said: “Research has shown that what we eat affects

us all differently; two people might have the same meal, but their post-meal response can vary wildly. People want to make healthy food choices but with so much conflicting nutrition advice, many of us are confused about what that looks like. Being able to easily monitor key dietary biomarkers will give you the knowledge to personalise your diet to suit your own body, to get healthy and stay healthy.”

In the future, the device offers potential for stress management, sleep health, sports performance, and early stage viral detection.

Nutromics ©

Smart contact lenses could diagnose and treat diabetes

T

ypically, type one diabetes is managed with regular injections of insulin and monitoring blood glucose levels throughout a person’s life. However, a research team at Pohang University of Science & Technology’s department of materials science and engineering, claims to have developed a wireless powered smart contact lens that can diagnose and treat diabetes by controlling drug-delivery with electrical signals. The research was published in the journal, Science Advances.

The smart contact lenses are made of biocompatible polymers and integrate

biosensors and drug delivery and data communication systems.

Professor Sei Kwang Han who led the research, explained how he believes that “the commercialisation of wireless-powered medical devices for diagnosis and treatment of diabetes and retinopathy is insufficient.” He added: “We expect that this research will greatly contribute to the advancement of related industries by being the first in developing wireless-powered smart contact lenses equipped with drug delivery systems for the diagnosis and treatment of diabetes, and treatment of retinopathy.”

DRONES SET TO DELIVER MEDICAL SUPPLIES BETWEEN UK HOSPITALS

I

n a new trial, drones will attempt to deliver medical supplies between two UK hospitals by flying over water.

The trial will run between 25th May and 5th June, and involve Lorn and Islands District

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General Hospital in Oban and Mull and Iona Community Hospital in Craignure, Mull.

It is hoped that this technology will provide frontline staff with the necessary equipment to carry out their

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jobs safely. Councillor Aileen Morton, leader of Argyll and Bute Council, commented: “Use of drones could assist vital equipment to be transferred more efficiently and effectively.”

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