MPN EU Issue 55

EUROPEAN EDITION

MEDICAL PLASTICS news ARE YOU PROTECTED FROM CYBERATTACKS? A POLYMER WHICH IS 100% PLANT-BASED AND RECYCLABLE THE USE OF ROBOTS IN CLEANROOMS

A minimal footprint New Engel compact cell houses all automation components

ISSUE 55

July - August 2020

WWW.MEDICALPLASTICSNEWS.COM

CYROLITE® acrylics for

blood diagnostics have such optical clarity that you can truly see it all!

We invented CYROLITE® over 40 years ago and have been perfecting it ever since. The result is that our high-clarity medical acrylics boast outstanding UV transmittance and, thanks to its excellent flow properties, can be molded into extremely thin-walled components. Additionally, CYROLITE® features resistance to a broad range of chemicals and disinfectants. So there’s next to nothing standing between you and the best results. We’ll fill you in on everything else at www.cyrolite.com.

CONTENTS July/August 2020, Issue 55

Regulars

Features

5 Comment Laura Hughes writes about the importance of protection from potential cyberattacks

10 Full circle Avantium highlights a polymer which is 100% plant-based and recyclable

6 Digital spy

18 Becoming eco-conscious How TEQ are implementing sustainable practices

8 Therapy area focus: Cardiology 9 Digital health 14 Cover story Engel discusses how Ypsomed relies on the company for its platform strategy 26 08:2020

21 A possible correlation Bedfont Scientific explores a link between FeNO and Covid-19 23 Why size matters in wearable technology TFC looks at the potential for wave springs in the wearables market 24 Rise of the robots Sepro Group explains what to look for in a robot for cleanroom moulding

WWW.MEDICALPLASTICSNEWS.COM

3

Trusted to protect…

Life science products that provide care, improve health and save lives We are a global technology provider to the life sciences industry, providing innovative packaging solutions and complementary products and services. We drive our customers’ success by delivering the best total value by combining superior quality and customer support, and the most efficient technology.

Custom Packaging Solutions Focused 100% on Healthcare Custom Medical Packaging solutions that provide superior quality and protection. Nelipak®-designed device packaging is based on market expertise from concept to the point-of-use.

Introducing the Nelipak Academy packaging webinar series!

For more information, contact us: Email: info@nelipak.com | phone: +1.401.946.2699

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

www.nelipak.com

Visit our website or email webinars@nelipak.com for more information.

FLEXIBLE PACKAGING MATERIALS

MEDICAL DEVICE AND PHARMACEUTICAL PACKAGING

A wide range of flexibility in materials and functionalities

Full-service solutions that provide superior quality and protection

Nelipak® Corporate Office Cranston, RI, USA

Nelipak® Elsham, United Kingdom

Nelipak® Humacao, Puerto Rico

Nelipak® Clara, Ireland

Nelipak® Galway, Ireland

Nelipak® Phoenix, AZ, USA

Nelipak® Derry, Northern Ireland, UK

Nelipak® Heredia, Costa Rica

Nelipak® Venray, The Netherlands

Nelipak® Whitehall, PA, USA

editor | laura hughes laura.hughes@rapidnews.com advertising | sarah livingston sarah.livingston@rapidnews.com head of media sales life sciences & plastics | lisa montgomery head of studio & production | sam hamlyn graphic designer | matt clarke junior designer | ellie gaskell publisher | duncan wood Medical Plastics News Europe Print Subscription – Qualifying Criteria UK & Europe – Free US/Canada – £249 ROW – £249 Medical Plastics News NA Print Subscription – Qualifying Criteria US/Canada – Free UK & Europe – £249 ROW – £249 FREE on iOS and Android devices Subscription enquiries to subscriptions@rapidnews.com Medical Plastics News is published by: Rapid Life Sciences Ltd, Carlton House, Sandpiper Way, Chester Business Park, Chester, CH4 9QE T: +44(0)1244 680222 F: +44(0)1244 671074 © 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.

Reproduction in whole or in part without prior written permission from the publisher is strictly prohibited.

BPA Worldwide Membership ISSN No:

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

Have you got sufficient measures in place to PROTECT AGAINST CYBERATTACKS? EDITOR’S COMMENT LAURA HUGHES

F

or years, the medical sector has been moving towards a more digital reality.

The benefits of implementing processes such as electronic healthcare records for both patients and healthcare providers, as well as devices such as pacemakers and insulin pumps which aim to improve patient care and ease the burden on healthcare professionals, have risen in popularity and use. However, the increasing use of digital technology has created what were potentially unforeseen or underestimated risks and resulted in the need for organisations to rapidly ensure methods are in place to protect themselves against potential cyberattacks.

Recently, the JSOF research lab has discovered 19 vulnerabilities, which have been given the name, ‘Ripple 20.’ These vulnerabilities reportedly affect hundreds of millions. It was given the name Ripple 20 because of the ‘ripple effect.’ Researchers wrote: “A single vulnerable component, though it may be relatively small in and of itself, can ripple outward to impact a wide range of industries, applications, companies, and people.”

The Guardian has also reported on cyber activity writing that UK security minister James Brokenshire commented Britain is “more than 95% sure” Russian state-sponsored hackers targeted UK, US and Canadian organisations involved in developing a coronavirus vaccine. As a result, Brokenshire has advised researchers who are developing vaccines in the UK to install a two-factor authentication on computer systems.

Therefore, it is clear that medtech security breaches are a very real and existing threat.

Medtech companies are, however, responding to these through launching new systems.

For example, GE Healthcare, a manufacturer and distributor, has launched a technology called ‘Skye’ which aims to bring together medical device expertise, artificial intelligence and process management tools to enable hospitals to detect, analyse and respond to cybersecurity threats in real time.

Additionally, the National Health Service (NHS) in the UK, has launched a procurement platform titled, ‘The Edge4Health’ which comes with an integrated cybersecurity feature. The platform developed by Orpehus Cyber notifies users if the security status is good, average or bad.

Another procurement platform has also been developed in partnership with NHS Digital and the National Cyber Security Centre (NCSC), with plans to run until May WWW.MEDICALPLASTICSNEWS.COM

2022. Phil Davies, director of procurement at NHS Shared Business Services described the launch of this framework as “timely” due to the new wave of cyberattacks and scams prompted by the Covid-19 pandemic.

The importance of protecting against cyberattacks should not be underestimated, and Natali Tshuva, co-founder and CEO of Sternum, an Israeli-based company which offers cybersecurity protections for medical devices, highlighted the importance of outsourcing help to prevent against attacks.

Tshuva explained how medical device manufacturers need advanced solutions to handle the advanced security threat on devices. She also made the important distinction that, “hospitals have their own defence mechanisms like a firewall or other security solutions to secure the hospital network itself.” This differs to distributed medical devices like pacemakers and insulin pumps which are both vulnerable and lack the network security solution to help secure them.

Dave Easton, director of Zener Engineering Services, a service provider and consultancy for health and life sciences, also explained how an effective cybersecurity approach was vital for medical device manufacturers.

Manufacturers are facing multiple challenges, including the demand for devices to be smaller, handle more data, become more digital, and yet remain cost-effective.

However, I think it’s really important for developers to consider the protection of any devices which could be targeted by cyberattacks at the development stage, and not as an afterthought. It also seems vital for companies to think about outsourcing help and advice to prevent against attacks which may be detrimental to both the users of the devices and the manufacturers.

I think it’s really important for developers to consider the protection of any devices which could be targeted by cyberattacks at the development stage.

5

DIGITAL

NEWS UPDATE

spy MEDTECH UPDATE

www.birmingham.ac.uk www.nature.com

New thermoplastic material offers potential for surgical procedures

www.skyrora.com

University of Birmingham © www.bcg.com

R

esearchers at the University of Birmingham have developed a new thermoplastic biomaterial. As the material is a type of nylon, its properties make it ideal for medical device applications such as bone replacements, where the additional flexibility within the implant material is desirable for minimally invasive surgical techniques.

Senior researcher, Professor Andrew Dove, claims the material offers, “a cost-effective, versatile and robust alternative in the medical device marketplace.”

Josh Worch, the postdoctoral researcher who led the work, added: “For many plastics, including nylon, the toughness is often dependent on their semi-crystalline structure, but this also makes them harder to shape and mould. However, our new plastic is as tough as nylon, but without being crystalline so it is much easier to manipulate. We believe this is only possible due to the way we have used stereochemistry to control our design.”

The plastic material is now patented, and the research team are exploring ways to fine-tune the material and its properties before looking for a commercial partner. The research has been published in the scientific journal, Nature Communications.

www.philips.co.uk

Philips ranks as the most innovative medtech company

P

hilips has been ranked as number 23 in Boston Consulting Group’s worldwide 2020 ‘Top 50 Most Innovative Companies’ survey.

This year’s position, which is six spots higher than where the company placed in 2019, makes Philips the highest ranked medtech company on the list, and places the organisation amongst one of only 162 companies to have ever appeared on the list in its 14 years of publication.

The ranking is based on an algorithm that takes four factors into account. The first three are

based on a survey of 2,500 global innovation executives - global “mindshare,” industry peer view and industry disruption. The fourth factor considered is three-year total shareholder return.

Jeroen Tas, chief innovation and strategy officer and member of the executive committee at Royal Philips, said: “Innovation is only relevant if it continues to deliver value for our customers and consumers. It is part of our DNA and we are proud we have again made significant steps up into the top 25.”

platforms for the navigation of catheters will continue to establish themselves in hospitals over the coming years. This is because the technology is proven to improve clinical outcomes by reducing the need for follow-up procedures and accelerating patient recovery, as well as reducing the workload of often over-burdened clinical staff.

Additionally, robotic navigation platforms are much cheaper than most surgical robots.

The findings by IDTechEx can

be read in the recently published report titled, ‘Innovations in Robotic Surgery 2020-2030: Technologies, Players & Markets.’

NEWS UPDATE

www.idtechex.com ROBOTIC SURGERY MARKET FORECAST TO REACH OVER $12 BILLION BY 2030

6

T

he robotic catheter navigation market reportedly has the fastest growth rate in the entire robotic surgery industry and is forecast to grow at 9.95% Compound Annual Growth Rate (CAGR) in the next decade. The growth is mainly thought to be due to the large companies who have entered the sector including Intuitive Surgical and Auris Health (owned by Johnson & Johnson).

Market research company, IDTechEx, predicts that robotic

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

DIGITAL SPY

NEWS UPDATE

www.epo.org

Healthcare sector generates the highest demand for 3D printing patents

A

ccording to a report published by the European Patent Office, the use of 3D printing with the healthcare sector has generated the highest demand for patents compared to other sectors, with a total of 4,018 applications from 2010 to 2018.

Europe is also displayed as being at the forefront of 3D printing inventions, with 47% of all 3D printing patents filed from 2010 to 2018 coming from within Europe. Germany accounts for the highest percentage of the European patents with 19.1%, followed by the UK, France, Netherlands, Switzerland and rest of EPC states (5%, 4.8%, 4%, 3.6% and 11% respectively).

The report also reveals that only two out of three patent applications were filed by large companies.

Organisations with 15 to 1,000

employees accounted for 10% (2,148) of applications across this time period, and individual inventors and small businesses with less than 15 employees generated 12% (2,584) of patents.

The report published by the European Patent Office is titled, ‘Patents and additive manufacturing – Trends in 3D printing technologies.’

First DO NOT HARM report is published

www.axial3d.com

Axial3D provides insight into the lungs of a Covid-19 patient edical 3D printing firm, Axial3D, claims to have provided the world’s first insight into the lungs of a Covid-19 patient with 3D printing.

Axial3D worked with the respiratory team at Belfast Health and Social Care Trust to produce a 1:1 scale 3D model of an actual Covid-19 patient’s lungs.

The organisations were able to do this by using CT scans taken from day 14 of the infection.

The 3D model was created using machine learning algorithms powered

by AWS and Formlabs Form 3 printing technology, with the lungs split into eight parts, and then joined together after printing with precision placed magnets. The benefits of splitting up the model is to enable healthcare professionals to see how deep the infection is and how it is affecting the patient’s lung.

Roger Johnston, CEO at Axial3D, said: “We now have this incredible

POINT

immdsreview.org.uk

MEDTECH UPDATE

M

talking

result, where we are now able to visualise lungs, like they have never been seen before. We’ve been able to provide the team with a completely new way of viewing and understanding the long term effects from the infection.”

Why was this review conducted?

The Independent Medicines and Medical Devices Safety Review was ordered by former health secretary Jeremy Hunt in 2018 to investigate the impact three treatments have had on patients. This included pelvic mesh implants.

What is included in the review?

The two-year review led by Baroness Julia Cumberlege is based on over 700 patient accounts, mostly from women alongside those in the healthcare system.

What are the findings of the review?

A major theme throughout the review is the healthcare system’s inability to know just how many women have been affected by the treatments, as well as an almost universal account of women not being taken seriously when reaching out for help.

The report makes nine recommendations including the appointment of a Patient Safety Commissioner, a patient-identifiable database for medical devices, and for the General Medical Council register to include a list of financial and non-financial interests for all doctors.

Pelvic mesh implants: Where do we stand now?

The report does not recommend a ban but says that specialist centres should be established in which operations can take place, but only as a last option for women needing stress urinary incontinence surgery.

7

CARDIOLOGY

Therapy FOCUS Demanding designs IAN BOLLAND, EDITOR OF MPN’S SISTER TITLE MED-TECH INNOVATION, CAUGHT UP WITH DR SAM PASHNEH-TALA, A RESEARCH FELLOW AT THE UNIVERSITY OF SHEFFIELD.

D

r Pashneh-Tala is researching the fabrication of blood vessels in unique geometries for use in surgery, developing new medical devices, and studying conditions like cardiovascular disease. Dr. PashnehTala has used Formlabs printers to design and create the blood vessel mould from the custom Biodegradable Polymer Emulsion he and his team developed.

WHAT LED YOU TO UNDERTAKE THIS RESEARCH? Cardiovascular disease is the number one cause of death worldwide and therefore there is a great need for replacement blood vessels.

Tremendous advances have been made towards producing tissueengineered blood vessels, but researchers have largely only been able to construct simple straight tubes.

This is where my research fits in. I use Formlabs 3D printers to enable the production of tissue-engineered blood vessels with a variety of geometries that can recreate the bends, tapers and branches of the vascular network.

My vision is to enable patient-specific vascular graft designs, tailored to each individual to provide improved surgical options.

Cardiovascular disease is the number one cause of death worldwide.

HOW CAN YOUR RESEARCH HELP MEDICAL DEVICE MANUFACTURERS? Currently, during the development of new vascular medical devices, manufacturers use synthetic blood vessel substitutes followed by testing on animals. My vessels offer a new testing platform to be used prior to animal testing, that could provide some of the mechanical and biological performance of native blood vessels.

The versatility of my tissue-engineered blood vessel technology also offers new opportunities to assist vascular surgeons. At present, surgeons most commonly utilise blood vessels harvested from elsewhere on a patient for vascular grafting (autografts). My technology permits the design of tissueengineered vascular grafts with shapes that may assist surgeons in the grafting process. These graft designs may allow procedures to be less complicated or quicker and could also improve graft performance by better controlling the dynamics of the blood flow through the graft.

WHICH MATERIALS WERE USED TO CREATE THE BLOOD VESSEL MOULD? I began by using silicone to produce the moulds that defined the shapes of the tissue-engineered blood vessels. I used Formlabs technology to 3D print negative moulds from their Grey resin that were then cast with silicone to produce the silicone moulds. The silicone moulds were then assembled and cast or injected with the biodegradable, photocurable polymer material that forms the scaffold on which the tissue-engineered blood vessels are grown.

After UV light exposure, to chemically crosslink the polymer, the scaffold is removed from the moulds, washed, sterilised, seeded with cells and then cultured in a bioreactor (also manufactured using my Formlabs 3D printer using their biocompatible and autoclavable Dental SG resin) to produce a tissue-engineered blood vessel. More recently, I have been exploring the use of Formlabs Elastic resin to directly manufacture the moulds I require.

WHY DID YOU CHOOSE FORMLABS TECHNOLOGY? My research requires rapid design iterations and the fabrication of new components. Formlabs technology allows me to print components in my lab in a matter of hours, saving costs and development time.

The access to desktop manufacturing that Formlabs technology permits also empowers international collaborations. As part of my research, I work with Aptus Bioreactors, based in South Carolina, to develop some of my bioreactor technology. Although Aptus and I are on separate continents, we both use the Formlabs Form 2 platform and are able to share designs digitally and manufacture quickly at our respective sites, allowing for rapid design progression.

WHAT DOES THE FUTURE HOLD FOR YOUR RESEARCH? My research developing tissue-engineered blood vessels is ongoing with various new projects underway or in planning. Over the last year I have widened my scope by beginning the development of a tissue-engineered vein valve as a potential curative solution for deep venous insufficiency. This project has been enabled by my ability to produce a diverse range of vascular tissue shapes. I also have a project in development that will provide the foundations for automating the design and manufacture of bespoke, patientmatched, tissue-engineered vascular grafts by combining medical image processing and 3D printing. Finally, I am engaged in the early stages of using my technology to grow the world’s first novel human organ, a tubular heart.

DIGITAL HEALTH

REECE ARMSTRONG, EDITOR OF EUROPEAN PHARMACEUTICAL MANUFACTURER, A SISTER TITLE TO MPN, REVIEWS A NEUROSTIMULATION HEADSET THAT TARGETS BETTER SLEEP AND MORE. BUT DOES IT WORK?

Nodding off

W

ith commercial companies starting to move into the realms of medtech, our health has become not just the focus of the healthcare industry, but that of the technology players too. Sleep is one such area, with a whole host of products now available aimed at helping us get to the magic land of nod.

So it was, we were sent the NeoRhythm headset to try out.

Developed by OmniPEMF, NeoRhythm deviates from other sleep wearables by being marketed as a ‘neurostimulation device for better living.’ Not only does NeoRhythm aim to improve users’ sleep, it also includes a range of other stimulation programmes, such as pain management and meditation.

NeoRhythm is backed by two (admittedly small) double-blind, placebo controlled studies.

WHAT’S IN THE BOX? NeoRhythm comes packaged in a sleek box with minimal fuss. The headband is aesthetically pleasing in the kind of clean, minimalist way that is often associated with tech products. Since NeoRhythm is gesture controlled, there’s little in the way of set-up, with instructions plainly printed on the box in a handy quick-start guide.

The NeoRhythm app too is fairly easy to navigate with each programme offering a range of handy information as to when to use the device and for how long. The app comes with a calendar which shows you which programmes you’ve completed so you can ascertain whether or not extended use of NeoRhythm has worked.

NeoRhythm is intended to be a user-friendly device. It’s operated by “gestures” which require users to tap the side of the headset to turn it on and operate programmes. For the most part the device was easy to use, though programmes occasionally stopped working via the app, requiring me to restart the device.

HOW DOES IT WORK? NeoRhythm is based on the study of pulsed electromagnetic field therapy, or field magnetic stimulation. Basically, the device generates non-invasive electromagnetic fields that pulse at certain frequencies, causing the wearer to produce neural oscillations (brainwaves) which the brain then associates with certain activities. For instance, by generating a frequency that is typically associated with sleep (4hz), NeoRhythm can help improve a person’s sleep. Or at least that’s the idea.

DOES IT WORK? I used NeoRhythm over a period of two weeks, following up with intermittent uses of various programmes, and had mixed results.

Primarily, I tested NeoRhythm’s sleep programme, which is to be used 20 minutes before one goes to sleep, or you can put it under your pillow for an eight-hour session. Not wanting to have an electrical device directly beneath my head for that amount of time, I opted for the former.

I found that it did lull me into a sense of tiredness during the first couple of nights, and the following mornings, I felt as if I had slept better. However, following uses failed to provoke any effect and my sleep was as normal: That is to say, erratic at best.

Other programmes also failed to have any effect on me, whether it was NeoRhythm’s programme for enhancing mental capacity to battle morning brain fog or improving my energy after a physical workout.

Why this is the case I’m not entirely sure. The booklet states to use NeoRhythm over a continued period but I assume, in the case of sleep, that I’m simply not the right person for it. I take a fairly long time to fall asleep usually, and the 20 minute window required by NeoRhythm may simply not be right for me.

IS IT WORTH IT? It’s tough to say. At €285 NeoRhythm is a major purchase and with mixed results I’d argue anyone wanting better sleep should focus more on achieving regular sleeping cycles. However, NeoRhythm is backed by two (admittedly small) double-blind, placebo controlled studies, and its mild effects on myself indicate that it could work better for other people.

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

9

RECYCLING MEDICAL PLASTICS

TOM VAN AKEN, CEO OF AVANTIUM, SPOKE TO MPN EDITOR LAURA HUGHES ABOUT PEF - A POLYMER WHICH IS 100% PLANTBASED AND RECYCLABLE.

FULL CIRCLE PLEASE START BY TELLING ME ABOUT THE DISCOVERY AND DEVELOPMENT OF PEF. There are two distinct primary problems caused by plastics. One is the growing amounts of single use plastic waste building up in the environment. The other is climate change, which has been driven by two centuries of heavy dependence on fossil fuels and feedstocks.

PEF is able to address both these problems by offering a 100% plantbased and recyclable polymer with a wide range of applications. The production of PEF from plant-based feedstocks utilises a renewable source, and a process with a significantly smaller carbon footprint than fossil-feedstock alternatives.

It also offers higher mechanical strength, which means that thinner PEF packaging can be produced, and fewer resources are required. PEF is designed for recycling and reusing, and therefore it fits perfectly in a circular economy, allowing you to feed the recycled plastic materials back into the same product cycle. This leads to direct reduction of new (“virgin”) PEF polymer required and reduces demands on plastic feedstocks.

WHAT EXACTLY IS PEF MADE OF? PEF is the end product of our YXY technology. The technology catalytically converts plantbased sugars (fructose) into FuranDiCarboxylic Acid (FDCA), this monomer then undergoes a polymerisation process to form the PEF resin. This resin can then be formed into the final product in the desired colour and shape. We’ve spent several years perfecting this technology, so it can support mass-market production volumes.

WHAT MAKES PEF DIFFERENT TO THE OTHER PLASTIC ALTERNATIVES ON THE MARKET? Though derived from plants, PEF has some unique properties that prevail over those of PolyEthylene Terephthalate (PET) - its nearest oil-

10

based equivalent, in many ways. First of all, it is stronger and far less gaspermeable, with a carbon dioxide barrier that is six to ten times that of PET. This is vital for prolonging the shelf-life of any packaged product. PEF also boasts improved thermal properties, appropriate for hot filling and cleaning at high temperatures. Finally, it is fully recyclable, so new products can be made entirely from old ones.

PEF CLAIMS TO BE ABLE TO GO THROUGH EXISTING RECYCLING SYSTEMS. PLEASE EXPLAIN WHAT THAT MEANS AND HOW CONSUMERS AND MANUFACTURERS WOULD RECYCLE THIS MATERIAL? We’ve done a great deal of work to ensure PEF fits into existing recycling streams. Because it is chemically very similar to PET, the two substances can be recycled together. PEF products can also be recycled entirely by themselves, using processes designed for PET. THE MATERIAL CLAIMS TO BE SUITABLE FOR MANY SECTORS, HOWEVER, THE MEDICAL SECTOR BRINGS ITS OWN REGULATORY CHALLENGES. WHAT STAGE IS PEF AT WITH REGARDS TO BEING USED WITHIN THE MEDICAL SECTOR? In addition to its renewable and circular proposition, PEF has a number of performance values to bring to applications in the medical sector, including its unique high barrier providing ultimate product protection, thermal behaviour, and solid mechanical properties. With respect to regulatory aspects, the implementation of PEF in the medical sector is in an early stage. We are aware of the additional requirements for medical applications and are currently building on collaborations with partners to further advance in this application field.

DO YOU ANTICIPATE ANY CHALLENGES OR HURDLES WITH THE IMPLEMENTATION OF PEF WITHIN THE MEDICAL FIELD? Currently, the regulations in the medical sector impose challenges in implementing truly circular solutions in this application field. We envision implementing PEF in a circular way, which will require collaborations throughout the value chain to develop solutions to this challenge.

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

Let BD Peripheral Intervention OEM Help You to Develop or Expand Your Current Cardiovascular Device Product Portfolio We provide a wide range of products and services to medical device OEMs, including: •

ePTFE components and services

•

Implantable textiles

•

PTA/PTCA angioplasty balloon catheters

•

Guidewires

•

Form dipping, coating and chemical compounding

Find out how we can combine BD’s technologies and longstanding commitment to quality to meet your unique medical device needs. www.bardpvoem.com/more-info Contact +1-800-655-8722 for more information.

© 2020 BD. BD and the BD Logo are trademarks of Becton, Dickinson and Company. BD-15968

CYBERSECURITY

IAN BOLLAND, EDITOR OF MPN’S SISTER TITLE, MED-TECH INNOVATION, SAT DOWN WITH RUSTY CARTER, VP PRODUCT MANAGEMENT AT ARXAN TECHNOLOGIES, ABOUT THE STEPS THAT MEDICAL DEVICE MANUFACTURERS ARE AND SHOULD BE TAKING TO PREVENT AGAINST CYBERATTACKS.

F

ollowing an interview three years ago with Rapid Life Sciences, Carter reflected on whether there was any great change during that period in the way device manufacturers were approaching protecting their devices, and what more there was to do.

He said: “I think the number of companies that have changed their behaviour is relatively small although I would say that it’s more on the very high end of those manufacturers.

“The good news is that the manufacturers that are developing medical devices are very concerned about patient safety, and as it pertains to their devices, both from a clinical standpoint but also now from a security standpoint. I talk to a lot of manufacturers that are either starting to adopt security controls, especially within the software, or they are asking me lots of questions about the threats that they face.”

device can’t necessarily trust that device; that kind of mutual authentication and that integrity across those interfaces is really important because the data becomes as critical as the physical device.

“The interface between the physical device and the mobile device that is controlling it is definitely a big potential risk because the mobile device, they’re no longer coming from the medical device manufacturer.

Carter also explained that device and hardware manufacturers face a number of IT and software development challenges, and that relying on third party providers in the manufacturing process is a critical element.

“Super computing platforms like iOS and Android, the phones are so powerful they can do a lot, but they’re open to a lot of other software. They’re open to compromising of the operating system, manipulation of the software and other applications.”

With the number of connected devices continuing to rise, Carter feels that nothing can be taken for granted when it comes to their safety.

He continued: “We assumed that the clinical setting is safe and that’s no longer the case. Assuming that your medical device is always in a hostile environment, and assuming any system that receives data from that

Ultimately the medical device manufacturer is going to be accountable for any risks and any potential damage.

12

Carter explained that two ways of providing security paths for such devices where they include proper code - and Arxan comes into, to strengthen the protection so it is harder for the device to be reverse engineered or tampered with.

“If security and developer teams look at their entire life cycle there are multiple points of interaction along that continuum and necessary feedback loops, you run source code analysis to find problems in the software, the most valuable piece of something like that is the information it provides back.

“As the application leaves the control of the developers, having that software feedback information into the operations of the business is critical and to give them visibility about the functioning and the security of the application.

“Ultimately the medical device manufacturer is going to be accountable for any risks and any potential damage and they’re in the business to help people. The clinician is not going to ask the patient if their device is rooted, what applications they also have on their device, is their application running the way it should – that’s not their area of expertise. Also, the manufacturer has that responsibility to the patient to ensure their safety and for them to understand how their application is performing in that interaction between the clinician and the patient. To get that feedback, both as to how the application is performing from a clinical and a security point of view, is really critical.”

WWW.MEDICALPLASTICSNEWS.COM

Polymers for Healthcare Applications

Whether it’s medical devices, pharmaceutical packaging or diagnostic equipment – countless healthcare applications can be realized using polymers from our portfolio.

Our team of experts will provide technical service, product safety, risk management and a deep understanding of market needs.

Do you process polymers?

Then we are your reliable partner.

ALBIS (UK) Ltd. albisuk@albis.com www.albis.com

POLYMER PROCESSING SOLUTIONS FOR

MEDICAL TUBING.

What are your tubing system needs? Tighter tolerances? Higher line speeds? Complex parts? Material issues? Whatever it might be, Davis-Standard will work with you to engineer and supply the precise extrusion system for all of your medical needs. Incorporating the latest extrusion, controls, tooling and screw technology, our sophisticated lab lines can support your medical tubing applications and product development such as microbore catheter tubing, multilumen tubing, bump tubing, and much more.

davis-standard.com tel

+44 (0)1384 471930

COVER STORY

A minimal footprint MANUFACTURER ENGEL DISCUSSES HOW YPSOMED RELIES ON THE COMPANY FOR ITS PLATFORM STRATEGY, AS WELL AS ITS NEW COMPACT CELL WHICH HOUSES ALL AUTOMATION COMPONENTS. The number of people suffering from diabetes grows globally by nine percent each year. For Ypsomed, a developer and manufacturer of injection and infusion systems for self-medication, this means increasing sales. The company, which is headquartered in Burgdorf, Switzerland, is consistently pursuing its worldwide course of expansion. Most recently, a completely new plant with 13,500 square metres of production space for injection moulding and assembly was built in Schwerin in Northern Germany. At its locations worldwide, Ypsomed produces pens, auto-injectors, and pump systems for administering liquid drugs, such as insulin, for large, brand-name pharmaceutical companies.

New products and manufacturing processes are developed at the company’s headquarters. This is also where the company’s own mould making and technology centre are located, and where new processes are trialled before they enter series production at the plants worldwide.

More efficiency and safety, as well as greater flexibility and faster industrialisation, were the main arguments which prompted Ypsomed to standardise its production processes in the course of further global expansion.

Integrated system solutions by Engel play a key role in the medical technology company’s new platform strategy.

TOP: Launched at K 2019: Engel compact cell. This houses all the automation components and is still significantly narrower than standard safety guarding.

(Engel ©) ABOVE: Ypsomed is expanding. Most recently, a new production plant was built in Schwerin and equipped with allelectric Engel e-motion injection moulding machines. (Ypsomed ©) BELOW: With its high degree of automation, the production of injection pens places high demands on the precision of the injection moulding process. (Ypsomed ©)

THE BIGGEST ADVANTAGE IS FAST INDUSTRIALISATION For a long time, the global injection moulding machinery consisted of machines of different types and brands. “This was no longer compatible with our expansion strategy,” reported Frank Mengis, Chief Operating Officer (COO) of Ypsomed. This explains why, five years ago, a decision was taken to standardise. “The aim of the new platform strategy is to further improve efficiency, safety and quality while simplifying our processes.”

“Standardisation is becoming a trend in the medical technology industry, and not only for the big players,” Christoph Lhota, vice president, medical business unit with injection moulding machine manufacturer and system solution provider, Engel, observed. “Ypsomed is a role model here. At a very early stage, we defined all the specifications in detail together, worked intensively on the performance specifications and then implemented them consistently.”

To date, more than 100 all-electric Engel e-motion injection moulding machines have been supplied to Ypsomed locations worldwide on this basis. The clamping forces vary – 800, 1600, and 2800 kN – but otherwise the machines are identical. Future needs were considered when selecting the options. Not all machines make use of the entire feature set right from the outset. Instead, the aim was to avoid retrofitting and the requalification associated with this later on. In this way, the platform strategy saves a great deal of time and money during operations.

“We can now order injection moulding machines virtually off the peg at all locations worldwide,” said Mengis. “But the biggest advantage is fast industrialisation. The qualification plans are identical for all new machines.

This means we can integrate new machines and new processes into series production far faster.”

The all-electric e-motion high-performance machines help Ypsomed ensure high-precision, zero-defect production. An important prerequisite for

14

WWW.MEDICALPLASTICSNEWS.COM

COVER STORY

competitive unit costs and trouble-free downstream processing of the injection moulded parts.

AUTOMATION ON A MINIMAL FOOTPRINT The injection moulding machines started everything off. In the meantime, Ypsomed has also started to standardise the automation of injection moulding processes. The e-motion machines are now being equipped with Engelviper linear robots. And the new compact cell by Engel also plays a key role. When developing the compact cell, which was presented for the first time at K 2019, Engel also focused on standardisation. Thanks to its standardised design, the new automation cell makes it particularly easy to integrate a wide variety of automation components and other downstream process units. It encapsulates all the components while remaining significantly narrower than standard safety guarding. “In terms of footprint, the compact cell is unbeatable,” emphasised Marlon Trachsel, process manager production technology at Ypsomed in Switzerland.

UNIFORM CONTROL LOGIC FOR EVEN SAFER WORK Like the machines, all the compact cells use an identical design to achieve maximum flexibility. To avoid having to change the auxiliaries during every mould set-up, the compact cells integrate all components needed for both free-falling parts and for soft depositing using viper robots. The process units for bulk material and soft depositing are arranged one above the other. This helps the compact cell to keep the automation extremely compact. “Where we have five production cells today, there will be six systems after the changeover to the standardised automation cells,” reported Trachsel.

DIGITALISATION DRIVES TREND TOWARDS SERVO-ELECTRIC MOULDS Already at the K show, the compact cell was demonstrated with a medical application. Housing parts for medical devices were manufactured on an e-motion injection moulding machine using a two component process with the aim of achieving shorter cycle times. Since the wall thickness of the cylindrical devices cannot be reduced for stability reasons, the two-component process is the only available option for achieving shorter cooling and cycle times. In an eight-cavity mould using Vario Spinstack technology by Hack Formenbau, and featuring a vertical index shaft with four positions, the basic body is first

moulded from polypropylene. The second position is used for cooling while another layer of polypropylene is injected at the third position. The parts are removed from the closed mould at the fourth position parallel to the injection moulding process, making an additional contribution to achieving a very short cycle time.

The two-component precision mould has a fully servo-electric drive in this application and uses a software programme newly developed by Engel. This ensures that the servoelectric movements e.g. the core-pulls - can be controlled in the same way as those of hydraulic systems. This means that the user themselves can program the servo-electric movements without the need for additional qualifications.

The software sees Engel paving the way for increased use of servo-electric moulds.

“Servo-electric motors offer more possibilities for sensitive monitoring of quality-critical process parameters to enable faults, downtimes and pending maintenance work to be detected at an early stage,” Gunnar Hack, managing partner of Hack Formenbau, made clear. At the K show, the Moldlife Sense System by Hack Formenbau demonstrated the huge potential that lies in digitalisation mould technology.

Just like intelligent assistance systems, such as iQ weight control or iQ flow control by Engel provide assistance for injection moulding machines, it will also be possible in the future to counteract critical conditions in the mould before rejects are produced or damage occurs due to wear.

Smart assistance and artificial intelligence are increasingly making inroads into injection moulding production, supporting the idea that the system worlds of the injection moulding machine and the mould will collide in the future. This is also a major topic at Ypsomed.

Standardisation has already been anchored in the company’s digitalisation strategy.

Standardisation is becoming a trend in the medical technology industry.

WWW.MEDICALPLASTICSNEWS.COM

15

Polyolefin Primer/Adhesive X21Med passes ISO 10993-5 test for non-cytotoxicity

VHP Decontamination Simple. Effective. Trusted.

• One component system • Low viscosity of <250 cps • Cures tough, not rigid • Room temperature cures

STERIS VHP® DC-A, Decontamination Chamber Atmospheric VHP DC-A minimizes bioburden and particles in material transfer to cleanroom manufacturing

154 Hobart Street, Hackensack, NJ 07601 USA +1.201.343.8983 • main@masterbond.com

STERIS VHP® LTS-V Low Temperature Sterilizer

THE LEADING VOICE IN POLYMER INNOVATION FOR THE MEDICAL DEVICE SECTOR

VHP LTS-V for terminal surface sterilization of sensitive drug delivery devices, implants and electronics Rely on STERIS Vaporized Hydrogen Peroxide low-temperature for your sterilization and decontamination needs. Ideal for the pharmaceutical & medical device industries, our solutions improve throughput and efficacy of material transfer and enable terminal sterilization of sensitive products.

For more information, please contact:

1-800-444-9009 | lifesciences@steris.com | sterislifesciences.com

www.masterbond.com

Medical Plastics News provides essential information on materials and engineering processes for anyone involved in the design, supply and manufacture of plastic medical devices.

SUBSCRIBE FOR FREE TO FIND OUT MORE VISIT www.medicalplasticsnews.com Medical Plastics News @MPN_Magazine

THERMOFORMING

MARC VAN KEULEN, LEAD DESIGNER, AND SEÁN EGAN, DIRECTOR OF GLOBAL MARKETING & VOC DEVELOPMENT, BOTH FROM NELIPAK HEALTHCARE PACKAGING, LISTS DESIGN PROCESS CONSIDERATIONS FOR AUTOMATED HANDLING TRAYS.

THINKING AHEAD F

or internal and external transportation of critical components or devices, automated handling trays play a crucial role in the automation process where speed, efficiency and high tolerances are a pre-requisite. At every step of the design process, decisions can significantly impact outcomes, creating a competitive advantage. Often there is more than one supplier of automated systems involved in decision-making related to positioning and handling of components and trays, and a wellqualified healthcare packaging partner can serve as an intermediary between all parties involved. By getting them involved in the project early, the best result can be achieved for the user and even the patient.

The first step of the handling tray design process is to identify the functionality the tray is intended for and determine specific logistics. By involving the packaging partner here, they can add maximum value by establishing where, by whom, and how the tray will be used and designing for optimal manufacturability. By visualising the complete story, requirements and even possible extra functionalities will be established.

SOME QUESTIONS TO ANSWER EARLY IN THE DESIGN PROCESS INCLUDE: • What will the orientation of the part and the tray in the assembly line be?

• Where, how and by whom will sterilisation and assembly be performed to create the final product?

• What kind of protection is necessary for the products or for stacking purposes? (e.g. dust protection, anti-static, stability, etc.)

• Are there options for different type of trays or end-user packs?

• What are the dimensions of the pallet that will be used for transport?

• Will transport occur by air, sea, or truck, and what are the dimensions of the transport container?

• What will the packing and storing conditions of loaded trays be like? (e.g. moisture, air temperature, light, barrier bags/lidding, straps, etc.)

• What will the inner/outer dimensions of the box be?

• What is the allowed carrying weight of the box or stack of trays?

• What tray size will fit on the existing automated line, conveyor or box, tub, crate?

• Will this be a cleanroom or non-cleanroom product?

• What will the product lifecycle be – single trip or reusable tray? If reusable, how many cycles and cleaning requirements?

• What type of validation and transit testing (drop, vibrations and compression)/conditioning/sterilisation/stacking weight/height will need to be performed?

Early on, concept sketching is recommended in order to verify the requirements and expectations of all parties involved. This creates a clear 3D visualisation of different potential variations and makes sure everyone is in agreement. This can lead to quicker response times and a smoother overall process.

Volume studies may be performed to establish the preferred orientation/ stacking direction and quantities of components, allowed tolerances of tray and part positions, construction features, material options, features for ease of de-nesting, and other important factors.

All movements of the tray should be considered during all logistic steps. For instance, manual or automated, and with stoppers, grippers, suction cups and/ or conveyors. It should be determined whether indentations will be necessary in the side wall for manual handling unloading the box. The handling speed of the individual trays and orientation on the conveyor should also be established, as well as quantities per tray, box, pallet or stack if required.

The injection mould configuration could provide some idea for quantities or layout configurations that will result in complete packaging density.

Another question to address is how the system will detect the position of the tray, for example, with light barrier, mechanical stoppers or cameras.

By working together early and assessing critical logistical factors during the design process, handling tray functionality can be optimised, and maximum value can be added along the way. Later, CAD designs will be used to finalise concepts and placement of functionality features prior to prototyping.

By working together early and assessing critical logistical factors during the design process, handling tray functionality can be optimised.

WWW.MEDICALPLASTICSNEWS.COM

17

CLEANROOMS

ANNE-SOPHIE BELAMINE, EUROPEAN SALES DIRECTOR AT TEQ, SPOKE TO MPN EDITOR LAURA HUGHES ABOUT HOW THE ORGANISATION HAS INCORPORATED SUSTAINABLE PRACTICES.

Becoming eco-conscious WHO ARE TEQ? TEQ manufactures innovative thermoformed packaging, and the company develops products for a range of markets, including consumer, component handling and medical from its ISO- and BRC-certified production facilities in the UK and central Europe, which includes cleanroom facilities.

Established in 1979, TEQ has more than four decades of experience in the design and manufacture of innovative thermoformed packaging and has worked with multiple companies from across the sectors.

TEQ, which was recently acquired

by Sonoco, has rebranded its business having previously been known as Plastique across Europe, and TEQ Thermoform Engineered Quality more widely.

As well as its two sites in Europe, TEQ operates three thermoforming facilities as well as one extrusion operation in the United States. The company also produces recyclable, moulded-pulp-fibre packaging under the Fibrepak brand.

HOW IMPORTANT IS SUSTAINABILITY TO THE ORGANISATION? TEQ is committed to incorporating sustainability into our overall business strategy, and helping customers achieve their environmental goals.

Sustainability underpins our thinking in everything that we do – both the products that we design and manufacture, and the way we run our operations. We create products with an environmental conscience, products of minimal size and weight, but which deliver superb quality. We are constantly developing innovative solutions that provide sustainability benefits for our customers.

for the production of precision-made and custom thermoformed medical packaging.

The cleanrooms, which are located in Nottingham and Poznan, are designed to meet medical device and pharmaceutical manufacturers’ most rigorous packaging requirements. The two sites are fully certified to meet the BRC IoP Global Standard which sets strict criteria for manufacturers of packaging for the food and cosmetics industries.

Our packaging solutions include trays, procedure sets, clamshells, tubs, covers, lids, sterile barrier blisters and seal blisters. We also manufacture custom thermoformed handling trays suitable for high-speed production, with automated assembly and transit. Handling tray solutions include autoinjectors, dry powder inhalers, injection-moulded components, pre-filled syringes and pharmaceutical bottles.

The task of improving the recyclability of plastic products within healthcare is an enormous one. Our TEQethylene Sterile Barrier System (SBS) uses a new, proprietary blend of HDPE in combination with Tyvek, a breathable HDPE thermoplastic lidding material, for a complete SBS solution backed by data that can help customers meet the requirements of ISO 11607-1 for stability or dating claim verification.

ARE THESE SUSTAINABLE OPTIONS AVAILABLE WORLDWIDE? Having both a North American and European presence enables TEQ to offer supply opportunities to both European and multinational medical device and pharmaceutical customers.

FINALLY, HOW DIFFICULT IS IT TO ENFORCE MORE SUSTAINABLE MATERIALS AND PRACTICES INTO ENVIRONMENTS SUCH AS CLEANROOMS? Our facilities enable us to manufacture innovative thermoformed solutions, such as sterile barrier packaging, engineered to maximise revenue, reduce cost, and increase our speed to market.

Now, with identical machinery and tooling on both sides of the Atlantic, TEQ can offer multinational customers shortened lead times, repeatability and uniformity together with a single global validation across a range of packaging solutions for the medical and pharmaceutical industries.

With 40 years’ experience working with many well-known brand owners, we’re proud to be able to offer our customers a range of custom-made solutions, developed in our cleanrooms in the UK, Poland and the US.

The task of improving the recyclability of plastic products within healthcare is an enormous one.

WHAT SUSTAINABLE PLASTIC OPTIONS DOES TEQ OFFER FOR CLEANROOMS? TEQ delivers a range of medical packaging solutions that are produced in cleanrooms based in both the UK and Poland. Designed, built and commissioned by pharmaceutical cleanroom experts, the facilities are certified to ISO 13485:2016, suitable

18

WWW.MEDICALPLASTICSNEWS.COM

CLEANROOMS

RON PARTRIDGE AND DAVID SEILER FROM ARKEMA, AND IGNA VAN DER WEIDE, FROM MATERIALS TECHNOLOGY SPECIALIST, ZOTEFOAMS, HIGHLIGHTS THE USE OF POLY VINYLIDENE FLUORIDE (PVDF) FOAM IN CLEANROOM INSULATION APPLICATIONS.

A

The perfect cushion

s products in the life sciences sectors become ever more sophisticated and the regulatory environment commensurately stricter, the standards that apply to manufacturing become increasingly more rigorous. This is particularly important in the construction and operation of cleanrooms.

The environment must be safe and sterile, resistant to contamination by particulates or microbes, and with materials robust enough to withstand aggressive chemical and high-temperature cleaning.

Construction materials for cleanrooms must therefore combine chemical stability, durability, purity, and fire resistance, as well as resist the development of mould, fungi, and other microbial species.

Polymer-based materials, in particular fluoropolymers, are often used in sheets or as a coating for walls, while foamed material is used to create lightweight structures, walls, partitions, ceilings, pipe and ducting insulation.

ZOTEK F high-performance foams, manufactured by Zotefoams from Kynar PVDF polymer, are the material used to produce T-FIT Clean, a range of insulation products purpose-designed for use in cleanrooms. PVDF films, coatings and foams are considered an appropriate choice, because covering exposed surfaces with PVDF provides a high purity ‘inert’ surface, which does not readily support the growth of microorganisms and provides the muchneeded resistance to withstand chemicals used today and possibly much harsher ones in the future for cleaning and sterilisation.

It is also important to consider fire resistance, low smoke generation, low moisture absorption, insulation values, abrasion resistance, and non-shedding characteristics to prevent the introduction of particulate contaminants into the manufacturing process, when selecting materials and surfaces.

ANTIFUNGAL PROPERTIES The low surface energy of fluoropolymers inhibits mould growth. ZOTEK F42 HTLS foam insulation was tested according to ASTM G21-15 (2015) Standard Practice for Determining Resistance of Synthetic Polymeric Materials to Fungi and the results showed no observed growth after the required 28-day exposure. The synthetic polymer portion of these materials is usually fungusresistant in that it does not serve as a carbon source for the growth of fungi.

It is important to establish the resistance to microbial attack under conditions favourable for such attack, namely, a temperature of two to 38°C (35 to 100°F) and a relative humidity of 60 to 100%. Therefore, it is also important that materials used are hydrophobic in nature. PVDF polymer is inherently very pure and hydrophobic.

continuous temperatures of 145°C and short excursions to even higher temperatures.

OTHER PROPERTIES Additionally, PVDF is resistant to sunlight (UV) and radiation exposure.

In the medical industry where gamma radiation is utilised for sterilisation, PVDF is known to be minimally affected by relatively large doses of radiation over time.

CONCLUSION Materials used in the construction of cleanrooms must demonstrate excellent chemical and fire resistance and must not support the growth of fungi and other microbial species.

Stringent cleaning and disinfection procedures are also critical to controlling fungal contamination in the cleanroom environment. Cleanroom materials must therefore possess excellent chemical resistance to be able to withstand the most aggressive chemical cleaning methods.

Zotefoams ©

FIRE RESISTANCE In order to limit fire and smoke risk in cleanrooms, Factory Mutual (FM) has established a fire and smoke standard called FM4910 (Cleanroom Materials Flammability Test Protocol).

Insulating foams are particularly susceptible to the effects of fire because of their high surface area, low mass, and high heat release rate. Many polymeric materials will readily burn and produce large amounts of smoke as well as contribute significant fuel load should a fire occur. They therefore require the addition of flame retardants to reduce the risk of fire and flame spread. By contrast, fluoropolymers, especially PVDF, prevent and minimise fire hazards.

PVDF is a pure polymer and is inherently flame-retardant without additives.

CHEMICAL AND THERMAL RESISTANCE Fluoropolymers exhibit superior chemical resistance and can withstand the harshest cleaning and disinfecting agents. PVDF resins are also resistant to a wide range of chemicals, posing little problem for Kynar PVDF. High-temperature cleaning is a very effective way to control bacteria development. There are versions of PVDF insulation that can withstand WWW.MEDICALPLASTICSNEWS.COM

19

8a/L27

COMPAMED

We Speak

Catheter WORK WITH THE EXPERTS

TM

• Global leader for diagnostic and interventional catheters from 1.1F to 42F • Custom devices from proximal ends to distal tips • Get your catheter to market FAST partner with our EPIC Medtec® Center in Ireland • Virtual, catheter development services available - work remote, no travel • Balloon catheters • Catheters with steerable tips • Micro-catheters

Ireland | USA

Let’s Get to Work on Your Project Phone: +00 353 61 331906 E-mail: oeminfo@teleflex.com Web: www.teleflexmedicaloem.com ©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 other countries.

Market-oriented.

Customized. RAUMEDIC. At RAUMEDIC, we develop and manufacture customized solutions for many different therapeutic areas.

The diversity of our customers is reflected by a broad spectrum of medical and pharmaceutical applications.

Learn more now at: www.raumedic.com/cardiosurgery

20-07-Anwendungsgebiete-Anzeige-Cardiosurgery-86x265-RZ.indd 1

21.07.20 12:59

DIAGNOSTICS

A possible correlation MPN EDITOR LAURA HUGHES REACHED OUT TO JASON SMITH, MANAGING DIRECTOR AT BEDFONT SCIENTIFIC, TO FIND OUT ABOUT THE COMPANY’S RESEARCH REVIEWING A POSSIBLE LINK BETWEEN FRACTIONAL EXHALED NITRIC OXIDE (FENO) AND COVID-19.

B

edfont Scientific has developed the breath analysis medical device, NObreath, which measures FeNO. Smith explained how the device was first developed in 2008 as a non-invasive aid in the management and diagnosis of asthma. He said: “The device works by analysing a breath sample and providing a FeNO reading in Parts Per Billion (PPB) which reflects a patient’s level of airway inflammation. The higher the level of FeNO, the higher the level of airway inflammation, indicating either undiagnosed or uncontrolled asthma.”

Ten years later, the second generation NObreath device was launched. This device differed to the original, with both new aesthetic and functional features designed to meet the market needs and demands. These included verification of successful breath tests, onscreen motivational exhalations guides, and a new aesthetically pleasing look with easily-serviceable parts.

Smith explained how, “one of the aesthetic updates was the move away from rubber casing to a polycarbonate/ABS blend, which enabled the NObreath to have a more stylish but clinical look.” The device also has a purple bezel to keep a splash of colour and to remain in line with the company branding.

Additionally, the plastic casing of the NObreath now also incorporates SteriTouch antimicrobial technology for optimum infection control as a medical device.

In terms of the lifespan, “NObreath has an unlimited testing lifespan and only requires one yearly service,” Smith highlighted. The polycarbonate/ABS blend casing around the serviceable parts also means that the annual service is quick and easy to perform.

Prior to the pandemic, the device was being used in both primary and secondary care to assist with the diagnosis and management of asthma.

Regular FeNO measurements indicate levels of airway inflammation, which can help healthcare professionals with a more tailored asthma diagnosis by preventing over-/under-/mis-diagnosis, as well as improving asthma management. FeNO measurements can be also be used to evaluate the effectiveness of inhaler technique, and also an individual’s ICS dosing.

However, during the pandemic, Smith discussed how a colleague suggested the potential role of FeNO levels in Covid-19: “One of our medical advisory board members, Prof. de Paula Vieira, explained to us that high levels of FeNO have been associated with bronchial inflammation, remodelling (fibrosis) and hyperresponsiveness in asthmatic patients, and especially asthma severity and prognosis. Thus, due to the nature of the inflammatory and rapid fibrotic process found in Covid-19 patients, he hypothesised that Covid-19 patients could present high levels of FeNO at the beginning of the disease. In addition, some mild and moderate symptomatic patients presenting Covid-19 symptoms have come to the hospital and some of them develop a more severe form of Covid-19.”

At the time, Bedfont had received lots of correspondence asking for medical and technical innovations that could help the current pandemic and so when Prof. de Paula Vieira approached the company with his theory, Smith said, “we thought it essential to explore whether FeNO had a direct

correlation to Covid-19 and donated the monitors and consumables necessary for the study.”

Currently, research is still in the early stages. A number of hospitals are participating, and FeNO testing is being conducted alongside other parameters. Prof. de Paula Vieira hopes to run this study for roughly another four months to ensure the data is robust.

In terms of study completion, Smith commented: “We hope to have some preliminary results by August, as one of the hospitals used for Covid-19 referrals is looking to test 400-500 non-hospitalised patients, and around 100 hospitalised patients. We aim to have collected enough data to finish the study in about four months’ time, and the final results should be analysed and released shortly after this.”

According to Smith, the organisation does not believe anyone else is actively reviewing a possible link between FeNO and Covid-19.

We aim to have collected enough data to finish the study in about four months’ time.

WWW.MEDICALPLASTICSNEWS.COM

21

CONNECTED DEVICES

ANKIT KEDIA, FOUNDER OF CAREMONT, A BANGALORE BASED MEDTECH START-UP, DISCUSSES THE PRESENCE OF CONNECTED HEALTH WITHIN THE MEDTECH SECTOR IN INDIA.

the new normal C

onnected health is a term which has become increasingly important, especially during this Covid-19 pandemic. Perhaps connected health is one of the most likely forms of technology to change the way people look at healthcare.

Providing care remotely using devices, smart sensors, Artificial Intelligence (AI), imaging techniques, and integration with smartphones, is how I would best define connected health.

CONNECTED HEALTH IN THE MEDTECH SECTOR IN INDIA In the medtech sector, connected health has received worldwide attention, especially in densely populated countries like India, where the ratio of doctors to patients is highly skewed. While there are several notable telemedicine applications and consulting platforms available, connected healthcare devices are yet to take off due to a lack of awareness, education, and the overall mindset of the patient to trust technology over the psychomotor skills of a doctor.

EXAMPLES OF CONNECTED HEALTH Currently connected healthcare apps like Mfine and Apollo 247 are some of the telemedicine apps that are making physicians available remotely, as patients are reluctant to take trips to clinics and hospitals due to fear of contracting Covid-19. In fact, many

private practitioners who have regular patients with chronic issues, have also employed simple practices like phone calls or video calls to provide consultations. The use of AI and Internet of Things (IoT) will help bridge the gap between caregivers and care receivers in a country like India, which has a fast emerging rural economy.

Several examples of connected health solutions include: • TriCog, which provides ECG devices to doctors and a mobile app for patients to find these doctors in case of emergency.

• An AI-based early-stage breast cancer screening device is currently being developed by Niramai- Bangalore.

• Caremont have partnered with a company that makes spirometers connected with smart phones to provide asthma patients with data on their lung function values, as well as a rehab device for Covid-19 patients to improve lung health.

THE BENEFITS Connected health could help India meet the needs of increasingly educated patients. It will be very beneficial to doctors and hospitals by cutting costs through real-time access to patient data, and improving workflow. It also helps insurance companies to reduce claim payments and provide assistance to deserving critical patients. In some cases, it will help pharma companies by allowing patients to begin medication sooner due to early detection of illness and diagnosis, and could also help to ensure compliance with treatments. In my view, one of the best uses of connected health technologies will be in rural areas of our country to provide remote health monitoring and enable patients to consult with their doctors in urban speciality hospitals from the comfort of their homes.

CHALLENGES One of the challenges with the use of connected health is two-way awareness between the doctor and the patient. Inherently, our population is used to receiving care with a face-to-face interaction with doctors, and changing this mindset will take time. Companies offering connected health technologies have to work towards integrating technology through continued persuasion and building a trust-based relationship with the patients. Other challenges, of course, lie in the regulatory framework of the country which will definitely get a facelift once the pandemic dust settles down. The biggest challenge with connected healthcare is the cost of developing these solutions and subsequently deploying them in the most cost-effective manner to be available to the masses. One also has to keep in mind that the government needs to fully advocate and endorse this connected health technology for it to coexist with some of their existing healthcare infrastructure and plans.

THE FUTURE India will witness a complete spectrum of the healthcare ecosystem, wherein small clinics will coexist with home healthcare, as well as large sophisticated hospitals. The focus is clearly shifting towards a preventative approach from a curative approach, with several connected healthcare solutions like ingestible pill monitors and nutrition sensors. AI doctors will become more common and personal IoT-based monitoring devices will change the way we track the health of individuals. AI will never replace the emotions of a physician entirely, but it will surely take over their work including certain decision making powers.

Going forward, AI will evolve from doctors versus machines to doctors and machines!

22

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

MAKING WEARABLE DEVICES

WHY SIZE MATTERS

IN WEARABLE TECHNOLOGY SIMON WARD, TECHNICAL MANAGER AT FASTENING AND FIXING SUPPLIER, TFC, EXPLORES THE POTENTIAL FOR WAVE SPRINGS IN THE GROWING WEARABLES MARKET.

I

n 1998, engineer Steven Mann built the worldâ&#x20AC;&#x2122;s first Linux-based smart wristwatch - earning him his reputation as the father of wearable computers.

Since then, companies have developed smartwatches and other wearable electronics for a variety of industries, including fitness, healthcare and manufacturing.

The Linux watch was designed to communicate wirelessly with PCs, mobile phones, and other wireless-enabled devices, allowing users to access emails and receive direct messages. As this technology became more popular in the consumer market, industry began to explore the potential of wearable devices, particularly in the medical sector. Patients can now wear highly accurate devices, such as blood glucose monitors, that give doctors more long-term data to help understand chronic diseases in more depth.

We have designed Crestto-Crest springs for insulin pens that help control and measure the dosage that is injected into the patient.

Another example is surgical and dental tools that use precision bearings to operate at high speed.

As different industries and consumers discover how wearables can help them, manufacturers are exploring new ways to design and improve these devices.

SMALL SCALE Size is one of the biggest challenges in wearable electronic device manufacturing. As these devices become more sophisticated, integrating all the required components becomes difficult. For example, the latest iteration of the Apple Watch contains technology capable of taking the userâ&#x20AC;&#x2122;s pulse and has ECG functions to provide critical health data - all in a 40mm wide case.

As the demand for these devices has increased, design engineers have had to find ways to improve the performance of these devices while reducing their size. For example, engineers have replaced coin cells with lithium ion batteries because of their improved energy density and smaller size. As end-users require more capabilities from a smaller device, manufacturers must carefully consider what components to use.

WAVE SPRINGS A wearable device such as a smart watch, is fitted with function buttons that will likely contain some form of return spring. It may also require springs to take up tolerances and maintain electrical contact. Due to space constraints,

Size is one of the biggest challenges in wearable electronic device manufacturing.

manufacturers find it impossible to fit a traditional coil spring into these small spaces so need to consider alternative solutions.

Wave springs may offer this solution as they require less than 50% of the space needed for more traditional springs. They can also be manufactured in different forms depending on the spring characteristics that are required in the application. By customising parameters such as the number of turns, number of waves, material type, and thickness, TFC engineers can design these wave springs to help manufacturers meet their product goals.

As manufacturers want to ensure that all the components feel right, it may take several iterations of a wave spring to find the optimal fit. As part of the process, TFC engineers will continually work with the OEM from initial concepts right through to SOP to ensure the optimal production solution.

Back in the early 2000s, Steven Mann predicted that wearable computers, such as his smart wristwatch, would become a common part of life in the future. Today, wearable electronics have evolved to offer a variety of applications, ranging from fashion accessories to life-saving devices.

No matter the application, wave springs can play a small, yet crucial role in developing the right feel for a compact, functional, and long-lasting device.

23

ROBOTS & AUTOMATION

CLAUDE BERNARD, PRODUCT MARKETING DIRECTOR, SEPRO GROUP, HIGHLIGHTS WHAT TO LOOK FOR IN A ROBOT FOR CLEANROOM MOULDING.

r se of the robots

R

obots are being used with increasing frequency in cleanrooms, for most of the same reasons they are becoming more common across all industries.

For instance, robots can improve efficiency, stabilise the process, and enhance workflow. Within the cleanroom market, robots can be used across the entire production process - from moulding to assembly to inspection, traceability and packaging.

Naturally, for use in a cleanroom, like any other piece of equipment, a robot must be designed, installed and operated so as to prevent contamination of the clean space.

In Cartesian or beam robots, which are the most commonly used in injection, areas where grease or other lubrication is used must be enclosed so that none can escape into the moulding area. All cables are protected in conduits and pneumatic air is filtered to 0.3 micron. All surfaces are smooth and free of logos, stickers, or other decoration to eliminate places where dust can accumulate and to

24

Claude Bernard

An ISO 8 cleanroom at MGS Manufacturing in Germantown, Wisconsin (USA)

make cleaning easier. Stainless steel is used in many components - like endof-arm tooling - that come into contact with the moulded parts.

Sepro 6-axis articulated-arm robots, developed in partnership with Stäubli, have a sealed housing, and the standard robots are suitable for ISO 5 (class 100) cleanrooms without modification. Therefore, injection moulding robots can meet all but the most stringent requirements. In fact, they can exceed the level of cleanliness possible with injection moulding processes.

INSTALLATION ALTERNATIVES The conventional way to install a Cartesian robot on an injection moulding machine is to mount it on the fixed platen (injection end of the machine) so that the main beam (X axis) extends from the area immediately above the mould and parts are unloaded to the side of the moulding machine. Here they can be placed on a conveyor or immediately packaged. The parts may also undergo secondary operations such as gauging or assembly, using human operators or additional robotic automation.

Robots can also be mounted axially, where the X-axis beam extends from the space above the moulding area along the centre line of the moulding machine so that moulded parts are discharged at the clamp end of the machine. In cleanrooms, this arrangement offers several advantages.

Firstly, when parts don’t need to be discharged to the side, it allows the machines to be placed closer together. In cleanrooms where floor space is often at premium, this can be a considerable benefit. Another potential advantage of axial mounting comes into play in applications that require the highest levels of environmental control. The IMM and the robot (installed in axial configuration) can be installed outside of the actual cleanroom, with the clamp end of the machine near a wall with an opening leading into a second room where higher cleanliness standards may be maintained. Parts can be quickly shuttled into the cleaner environment for final processing or assembly.

In any case, the moulding machine and the robot will need to be guarded to protect human operators from injury due to coming into contact with the moving robot. The metal profiles into which guarding panels are mounted should be closed on any side that doesn’t need to receive a panel. Instead of the wire mesh commonly used in general industrial applications, the guarding panels themselves should be made of PET polyester or other clear plastics that can be easily wiped clean. Cables should be routed in closed wiring ducts, and all ducts, drawers, and other components should be stainless steel, electro-polished for easy cleaning. The number of supporting legs on the floor should be kept to a minimum. Similar design rules apply to conveyors.

Robots and automation systems will continue to play a crucial role in medical injection moulding. Automation technology can be expected to continue to advance as market forces demand it to do more, and as robot technology evolves.

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

STERILISATION & AUTOMATION

Changing gear JUHA MATTILA, DIRECTOR, STERILISATION TECHNOLOGIES, STERIS LIFE SCIENCES, EXPLAINS HOW TO MITIGATE RISKS IN CLEANROOM MANUFACTURING FOR THE STERILISATION OF GOODS, AND HIGHLIGHTS THE GROWING TREND OF UTILISING AUTOMATED AND VALIDATED VAPORISED HYDROGEN PEROXIDE (VHP) MATERIAL TRANSFER DECONTAMINATION.

M

anufacturing sterilised goods is more than just the terminal sterilisation step at the end of the drug delivery device or other medical device manufacturing line. Quality of the end-product depends on the preceding process steps such as raw materials, cleaning, packaging, component sterilisation and material transfer to cleanroom.

Automation of pharmaceutical manufacturing processes, related operations, and material handling are driven by the constantly growing need to mitigate any risks associated in the production of drug delivery devices and other medical devices. Any manual processing activity presents a greater risk for the end-product quality, regardless if a process takes place inside cleanroom or isolator space, or if it takes place before entering the cleanroom manufacturing area. One such process is material transfer and its related decontamination process for minimising bioburden in material transfer into cleanrooms.

Material transfer of pre-sterilised components (e.g. stoppers, vials, syringe components) is carried out using sterilisation bags covered with one or more, typically LDPE, plastic bag layers. These enable protection of goods entering from lower classification areas to higher, such as going from D to C areas, or from C to B areas. Once entering an airlock, the bag surface is wiped with alcohol or another suitable disinfectant for minimising bioburden in transfer.

When transferred to the other side, the bag outer surface is then removed, and the wiping of the possible next bag layer is repeated until the destination is reached (class A = isolator space).

The above described manual method is very time consuming, labour intensive and difficult or impossible to validate, as each process is always manual. Such a process is a true bottleneck for many pharmaceutical or medical device manufacturing facilities striving to continuously improve productivity and quality.

In response, automated material transfer using atmospheric VHP or generally VHP chambers has increasingly replaced manual methods. This technology provides greatly improved efficiency in decontaminating transferred bags, instruments and tools outer surfaces in both existing manufacturing operations and greenfield facilities that have been directly designed for using automated processes as much as possible.

VHP material transfer decontamination chamber cycles are manually loaded and un-loaded to carts or hooks on carts, and then pushed into the chamber. In continuous high capacity throughput systems, however, automated loading and unloading systems can be integrated to the chamber. A VHP material transfer decontamination process consists of three main phases: Preconditioning (de-humidification and possible conditioning), decontamination exposure (validated 10-6 log reduction result when using Geobacillus Stearothermophilus spore biological indicators), and post-conditioning (aerating the load by removing VHP residual by catalyser and turbulent airflow).

Typical cycle times vary between 45 and 100 minutes depending on the materials being decontaminated.

Longer cycle times (over 60-70 minutes) are most often required for cellulose tags or partial covers of bags in the load, which may need prolonged aeration to reduce peroxide residuals down to allowed unloading PEL/OSHA levels of one to three ppm. Chamber sizes vary between small box-size dimensions to small cleanroom-size applications.

25

According to a survey on medical device companies by Prisym ID… 1

36% said the pandemic had caused more than two months of interruption.

2

17% said it had been longer than one month.

3

17% said it had been less than one month.

4

30% did not experience disruption.

08:2020 SCIENTISTS REVEAL A FULLY TRANSPARENT SURGICAL MASK

T

he mask has been developed by researchers at Empa and EPFL and is the end product of two years of hard work.

The idea behind the transparent ‘HelloMasks’ is to allow more personal contact and communication between healthcare professionals and patients. These masks also aim to overcome any issues with partially transparent masks, which tend to make it difficult for the wearer to breathe and often fog up easily.

The fully transparent masks are made from a polymer which is developed specifically for this application. They are designed with small gaps to allow air to

pass through, but to prevent the transmission of viruses and bacteria. A biomass-based material is used to fabricate the masks, and Thierry Pelet, HelloMask project head, said: “We’ll keep working on them until they’re completely ecofriendly.”

Completion of a CHF one million fundraising round has been announced, and the company are ready to develop the industrial process, with a planned market launch in early 2021. Researchers have created a start-up called HMCARE to market them, and initially the masks will be sold to the medical community.

EPFL ©

Researchers 3D print a functioning human heart

R

esearchers at the University of Minnesota have 3D printed a functioning centimetre-scale human heart within the lab.

To achieve this, the researchers used a different approach, suggested by two Ph.D. students, Molly Kupfer and Wei-Han Lin. “At first, we tried 3D printing cardiomyocytes, and we failed, too. So, with our team’s expertise in stem cell research and 3D printing, we decided to try a new approach. We

optimised the specialised ink made from extracellular matrix proteins, combined the ink with human stem cells, and used the ink-plus-cells to 3D print the chambered structure. The stem cells were expanded to high cell densities in the structure first, and then we differentiated them to the heart muscle cells,” said Brenda Ogle, lead researcher on the study.

The research is published in the American Heart Association’s publication titled, Circulation Research.

MEDTRONIC PLANS TO ACQUIRE MEDICREA

M

edical device company, Medtronic, has announced plans to acquire Medicrea, a company focused on transforming spinal surgery through artificial intelligence, predictive modelling, and patient specific implants. Medtronic believes that the partnership will strengthen the company’s position as a global innovator

26

in enabling technologies and solutions for spine surgery.

Jacob Paul, senior vice president and president of the Cranial & Spinal Technologies division at Medtronic, said: “Medtronic will become the first company to be able to offer an integrated solution including artificial intelligence driven surgical planning, personalised

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

spinal implants and robotic assisted surgical delivery, which will significantly benefit our customers and their patients.”

Denys Sournac, founder, chairman and CEO of Medicrea, added: “We are thrilled to be joining forces with Medtronic because we share a similar mission to restore the long-term quality of life for patients.”

The shawpak is a revolutionary machine offering a thermoforming solution to your medical packaging needs that is totally unique

IDEAL FOR INTEGRATION INTO ROBOTIC CELLS AN OPTIMUM SINGLE-PIECE FLOW SYSTEM BLISTER PACKAGING FOR MEDICAL DEVICES SEE US AT MED-TECH INNOVATION 29th-30th June 2020 Hall 1, Stand F9

shawpak Riverside Medical Packaging, Newmarket Drive, Derby. DE24 8SW. T +44 (0) 1332 755622 | F +44 (0) 1332 757722 W www.shawpak.co.uk | E sales@shawpak.co.uk