MPN EU Issue 41

MEDICAL PLASTICS news

+ WHAT DOES 2018 HOLD FOR THE MEDICAL PLASTICS SECTOR? DRUG DELIVERY EXPERTISE HIGH PERFORMANCE POLYMERS

Living the dream How Trinseo polymers help us lead an active life ISSUE 40

Jan-Feb 2018

WWW.MEDICALPLASTICSNEWS.COM

Medical Solutions

Complete solution provider, from concept to full scale production

s, Hall 7.1 de Versaille Expo, Porte ris Pa 18 20 ry 7&8 Februa

0 4 A d n a t S t a s Visit u

Global Turnkey Solution Provider With over 75 years of experience in product development, advanced polymer processing, including assemblies and various post-processes, we offer you unique and reliable services.

Customer Solutions

Facts & Figures

• • • • • • • • • •

• • • • • •

Anesthesia & respiratory devices Cardiovascular devices Diabetes care devices Drug delivery devices In vitro diagnostics Laboratory Nephrology & urology devices Ophthalmic devices Ostomy devices Primary plastic packaging

Robust Design.

Developed to save time & cost.

Founded 1938 in Sweden Over 1300 employees 12 production sites worldwide Technical design centers in EU and US 90 000 m² production area 500+ moulding machines (IM thermoplastics & silicones, IBM, EBM) • 70+ assembly lines

www.nolato.com

CONTENTS Jan-Feb 2018, Issue 40

Regulars

Features

5 Comment Lu Rahman looks backwards and forwards across the sector

25 Taking a view Lu Rahman looks at what 2018 holds for the sector

7 News focus Where are we with the vaginal mesh scandal?

30 Breathe Easy Dow Medical Solutions, examines how versatile LSRs can help medical device makers

8 Digital spy 11 News focus Can Scotland achieve its life science potential and how should we view Industry 4.0?

15 News analysis ISO 13485 in discussion

33 Land of opportunity Lu Rahman looks at where the growth lies in drug delivery plus expertise from Lubrizol 37 Clean getaway Steris Finn-Aqua, discusses VHP low temperature sterilisation

38 What lies ahead Invibio and augmented biomaterial for the next generation of spinal implants 42 Got it covered BioCote shares expertise on coatings that control infections 45 Let’s go round again Is it possible for medical plastics to be part of the circular economy?

48 System addict Lu Rahman looks at some successful robotic installations and future developments

18 Opinion Velox looks at the pitfalls of polymers and Huthwaite International offers sales advice 22 Cover story Trinseo explains how its polymers help us lead an active life 50 02:2018 WWW.MEDICALPLASTICSNEWS.COM

3

Your trusted partner from design to manufacture Connecting the pieces Discover our wide range of medical polymer solutions that will help you bring your products to the market faster and with more confidence.

Paris Expo, Porte de Versa CONTACT US TODAY France: T +33 (1) 47 99 91 67 | medical@ultrapolymers.fr | www.ultrapolymers.com Please visit our website to find your local contact details and country-specific supply restrictions

illes

7 & 8 February 2018 Visit us on Stand L12

CREDITS

EDITOR’S

head of content | lu rahman

comment

deputy group editor | dave gray reporter | reece armstrong advertising | gaurav avasthi art | sam hamlyn graphic design | matt clarke publisher | duncan wood Medical Plastics News is available on free subscription to readers qualifying under the publisher’s terms of control.

Those outside the criteria may subscribe at the following annual rates: UK and Europe: FREE North America: £249 Rest of the world: £249 subscription enquiries to subscriptions@rapidnews.com

Medical Plastics News is published by: Rapid Life Sciences Ltd, Carlton House, Sandpiper Way, Chester Business Park, Chester, CH4 9QE T: +44(0)1244 680222 F: +44(0)1244 671074 © 2018 Rapid Life Sciences Ltd While every attempt has been made to ensure that the information contained within this publication is accurate the publisher accepts no liability for information published in error, or for views expressed. All rights for Medical Plastics News are reserved.

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

BPA Worldwide Membership

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

These are the good times

I

t’s always enjoyable thinking about what to write each issue. And at this time of year there’s the tendency to reflect on the last twelve months and how events have played globally as well as the effects they may have had on the medical plastic device industry.

It’s been an interesting year with certain topics coming up for discussion time and again. Unfortunately, the gender pay gap appeared in the headlines too many times. Sadly, many businesses haven’t addressed salary discrepancies and we are still hearing reports about unbalanced male and female salaries across all manner of industries. I’m hoping that 2018 might be the year we see a concerted shift and a commitment from businesses to stamp out wage inequality. Last year Economia ran the headline ‘Number of women in FTSE 350 board pipeline stagnates’, and found that there had been ‘no progress over the last year in the number of women on executive committees which are the pipeline of talent to the board’. A positive initiative to remedy this has to happen soon across all businesses and industries.

Another stand-out topic in 2017 was waste, namely plastic waste.

Media images of oceans filled with goods we no longer wanted and had discarded were commonplace and of course it has made us question how we consume and dispose of plastic items. I’ve written much on this in recent months and it’s tricky. Medical plastics are like other plastics. We can ban plastic straws, we can see the sense in reducing plastic packaging in the supermarket, but we can see few alternatives to single-use plastic medical devices. And where packaging is concerned, the need for devices and /or drugs to withstand travel, temperatures, tampering overrides

issues of sustainability. That said, it isn’t impossible for the plastics industry to look at the way it produces and disposes of waste. Initiatives are taking place to address healthcare waste with groups such as the Healthcare Plastics Recycling Council taking the lead on this important subject.

It’s good to end on a positive note so learning that UK manufacturing had hit a four-year high in November last year was welcome news indeed. The Guardian reported: “Britain’s factories are enjoying the best business conditions for more than four years as strong demand at home and abroad boosts order books, production and jobs”, following reports that the purchasing managers index (PMI) rose from 56.5 in October to 58.2 in November – apparently the 10th best position in the survey in 26 years.

It’s good to end on a positive note so learning that UK manufacturing had hit a four-year high in November last year was welcome news

And it hasn’t just been in the UK that manufacturing has been experiencing favourable growth with stronger reports coming from the Eurozone where manufacturing has achieved its best performance since the single currency began.

Armed with this market buoyancy let’s hope we can enter 2018 on a high and keep it there. There are exciting times ahead and many opportunities to grab.

WWW.MEDICALPLASTICSNEWS.COM

5

2016 nce Excelle Growth rship Leade Award

Bormed™ Because we care

Borealis has been awarded with the prestigious Frost & Sullivan 2016 Growth Excellence Leadership award for the European polyolefin healthcare market.

Reliable plastic solutions for the safety of patients Borealis and Borouge are leading suppliers of innovative plastic solutions that add value for all stakeholders in the healthcare value chain – from pharmaceutical company to patient.

With more than 35 years of experience, we enable customers to meet their need for high-quality, lightweight and aesthetic products. We focus on delivering excellence by working in line with the principles of Commitment, Service and Conformance. Our portfolio of Bormed™ products, as of Q2 2018 also compliant with the USP 661.1 requirements, is the result of our continuing dedication to our industry.

For more information visit: www.borealisbecausewecare.com

6

Our Bormed™ portfolio of polyolefin solutions offers superior technical performance for medical devices, pharmaceutical and diagnostic packaging. We guarantee the security of our supply and provide technical support tailored to the specific and stringent requirements of the market. Furthermore, we offer a global service from our locations worldwide, ensuring fast and reliable delivery.

We are dedicated to the quality of your products – for the safety of patients – because we care.

Visit us at MD&M West 2018 stand 1365 and at Pharmapack 2018 stand F47, Hall 1

WWW.MEDICALPLASTICSNEWS.COM

NEWS FOCUS

The mesh scandal: Where are we now?

I

The pelvic mesh scandal isn’t going away with many women reporting severe adverse effects of the product.

Reece Armstrong has been following events and outlines where we are now

n July 2017, 60 women marched towards Westminster to meet with MPs to discuss the life-changing effects that had occurred due to mesh implants.

While not the first public admission about the devastating effects of mesh, it was perhaps the most symbolic. Women shared their harrowing stories about how mesh had changed their lives for the worse, detailing chronic pain, psychological damage and even the removal of organs after mesh had eroded in their body.

Mesh implants are made from polypropylene and are used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI) after childbirth. The meshes, a common treatment for SUI and POP, are designed to provide extra artificial support for weakened or damaged tissue.

Shortly after that meeting in July, the NHS published its Mesh Oversight Group Report stating that the use of ‘mesh to treat women with SUI and POP is a safe option’.

While the report outlined recommendations to help improve access to information, consent and clinical guidance, it ultimately resulted in patient leaflets being available in GPs and a change in the way that problems caused by the mesh are reported.

The campaign group, Sling the Mesh, which organised the parliamentary meeting responded with criticism about the report.

The group’s leader, Kath Samson, said: “They should have looked at product safety, not at ways to fix women once things have gone wrong. How can a major study of mesh not look at mesh safety?

Since the report, diligent campaigning from women all over the world has brought attention to the mesh implants with multiple court cases being brought against the device manufacturers.

In October last year, Johnson & Johnson, one of the major manufacturers of the mesh implants, was taken to court by a woman in the US for injuries caused by the company’s mesh implant.

Ella Ebaugh had a mesh implant operation in 2007 after suffering from incontinence. After her condition didn’t improve, she had a second mesh device implanted. However, Ebaugh suffered from a range of complications such as pelvic pain and urethral erosion and had to undergo three corrective surgeries.

Ebaugh ended up receiving $57 million in damages from Johnson & Johnson after the court ruled that the company was liable for causing injury and that its devices were negligently and defectively designed.

Unfortunately, mesh implants have been the result of much worse complications for a certain number of women. Between 2008 and 2010 for instance, the FDA found that there were ‘seven reported deaths associated with POP repairs’ . More so, in November last year a 42-year-old woman from Canada died from sepsis caused due to what her family believes was mesh related troubles.

In that same month here in the UK, health watchdog NICE recommended that vaginal mesh products be banned from treating prolapse due to safety concerns. The news came as a small victory for women even after calls for a public inquiry into the devices was

WWW.MEDICALPLASTICSNEWS.COM

rejected by the parliamentary under-secretary of state for health, Jackie Doyle-Price.

About the news, Owen Smith, chair of the All Party Parliamentary Group on Surgical Mesh Implants, said he was “pleased that NICE have listened to women” but added that “they should have gone further and followed the example set by New Zealand this week in banning mesh altogether for pelvic operations.”

Whilst the NHS doesn’t have to act on the recommendations set out by NICE, it may suggest that a ban on the devices is on the horizon. Currently, NICE is developing guidelines into the use of mesh for SUI and POP, though this won’t be published until 2019.

A long time to wait but it does seem like the UK and indeed the rest of the world is pushing towards better regulation and clinical use of mesh products. What we can hope for is that the UK follows examples set by Australia and New Zealand, both of which have banned the devices due to concerns over safety. Until then, women need to be made aware of the health and psychological problems that can be caused by mesh, though thankfully we have a number of strong and altruistic campaigners raising awareness here in the UK.

7

DIGITAL SPY

DIGITAL

spy

wyss.harvard.edu Small wonder: miniaturised origamiinspired robot with microassembly potential

DIGITAL UPDATE

I

www.cardiffmet.ac.uk

Cleaning up

C

STERILISING DEVICE FOR MEDICAL EQUIPMENT SCOOPS GRANT

ardiff Metropolitan University has secured funding to support an interdisciplinary collaboration arising from the Welsh Crucible programme that looks at the design and development of an innovative sterilising device for venous access ports (VAPs).

an innovative prototype device to prevent and clear infections in VAPs. The success of this project could mean better care for patients who use venous access ports and could potentially save the health care system significant sums of money.

The research is a collaboration between Cardiff and Vale University Health Boards All Wales Adult Cystic Fibrosis Centre, Cardiff Metropolitan University’s PDR (the Cardiff Met-based International Centre for Design & Research), University of South Wales’ Faculties of Business and Society and Computing, Engineering and Science, Cardiff University’s School of Dentistry, and Public Health Wales’ Department of Microbiology.

Speaking about the project and grant award, Dr. Taslima Begum, in her roles as senior lecturer in computing at Cardiff Met and researcher in user-centred design at PDR, said: “I am thrilled that we have been awarded the research grant. Our aim is to utilise user-centred and codesign methods to develop a novel solution that will help cut down infections in individuals who use venous access ports and as a result, improve the patient’s qualityof-life through better treatment outcomes. It is a fantastic project and I am looking forward to collaborating with some exceptional individuals, organisations and institutions on it.”

The project’s aim is to develop a sterilising device to reduce infections in VAPs for patients who require long term and repeated intravenous treatment. A VAP is a small medical device that is implanted under the skin to allow regular and convenient delivery of drugs into the bloodstream without compromising the patients’ veins. The project team will work closely with the Cystic Fibrosis Centre to address an issue faced by both clinicians and patients particularly individuals living with Cystic Fibrosis who use these ports.

One major issue with the existing device is the build-up of bacteria and fungus within the port, which can lead to infections, patient morbidity and require surgical removal of the device which can cause pain and discomfort for the patient. Antibiotic treatment is not an effective solution and around 5% of all VAPs fail due to infection.

To overcome this issue, the project team aim to develop

8

DIGITAL SPY

In addition to securing the research grant for the VAPs Project, Dr Taslima Begum at Cardiff Met has also secured funding for two additional pioneering projects, including developing a smart surgical tool for optimal dental implant fixation to reduce failure rates and another for communicating the complexities of climate change through co-designed computer games development.

Dr. Taslima Begum, says she is thrilled to have been awarded the research grant.

nspired by pop-up books and origami a team at a team at Harvard’s Wyss Institute for Biologically Inspired Engineering and John A. Paulson School of Engineering and Applied Sciences (SEAS) has developed a microfabrication approach that enables the assembly of robots from flat sheets of composite materials. Pop-up MEMS (microelectromechanical system) manufacturing creates dynamic centimeter-scale machines that can simply walk or fly away. The researchers applied their approach to develop a Delta robot measuring a mere 15 mm-by-15 mm-by-20 mm.

Because of their high precision and speed, Delta robots are deployed in many industrial processes, including pick-and-place assemblies, machining, welding and packaging.

Over time, roboticists have designed smaller and smaller Delta robots for tasks in limited workspaces, yet shrinking them further to the millimetre scale with conventional manufacturing techniques and components has proven fruitless.

The team has integrated its microfabrication technique with

multi-functional composite materials to create the ‘milliDelta robot,’ which can operate with high speed, force, and micrometer precision, opening potential applications for it in micromanipulation tasks in manufacturing and medicine.

The team demonstrated that the milliDelta can operate in a workspace of about seven cubic millimetres and that it can apply forces and exhibit trajectories that, together with its high frequencies, could make it ideal for micromanipulations in industrial pick-and-place processes and microscopic surgeries such as retinal microsurgeries performed on the human eye.

DIGITAL LAUNCH

www.panacol.com Sniff test: Panacol launches lowodour high-performance adhesive

P

anacol has a new twocomponent high-performance structural adhesive in its product range. Penloc GTN is an easy-to-process methyl acrylate based low-odour adhesive that can be used in a variety of applications.

Penloc GTN adheres well to a range of materials including PVC and similar materials. The performance adhesive is said to boast a high power transmission capability and excellent

WWW.MEDICALPLASTICSNEWS.COM

thermal stability. It is both flexible and offers superior adhesion. Compared with other methyl acrylate adhesives, Panacol says it has the advantages of a low odour formation and a long processing time of ten to 15 minutes.

To allow effective monitoring of blending quality, the two components of Penloc GTN have different colours that, applied thinly, change to a grey, almost colourless surface as the blend cures.

DIGITAL SPY

DIGITAL UPDATE

www.medicalplasticsnews.com

What industry trends will be strong in 2018?

Connected devices and distance health Chronic disease is on the up and so too is the need for devices to treat conditions such as diabetes, especially ones that operate remotely. According to Diabetes UK by 2025 there will be 5 million people with diabetes – that’s 17 people diagnosed every hour.

Given the applications for many medical plastic devices, and the risk that re-use would pose to health, the argument for throw-away products is clear. However, looking ahead, recycling, material choices and the way we dispose of products is going to have increasing impact on the sector.

Due to increasing numbers of the population demand connected devices and benefit from the ability to access care and monitor their illnesses form home, this market is flourishing.

Sensor technology From microdfluidics to the proliferation of connected devices, sensor technology has never been more important. According to Allied Market Research (AMR), the global market of sensors is set to reach $241 billion in 2022. The key drivers are cited as the Internet of Things and wearables. 2018 will see more importance placed on the development and manufacture of sensors that have the capability of meeting the needs of increasingly technological products.

Distance health has become a key word in healthcare with hospitals taking increasing advantage of mobile technology and looking to include telehealth initiatives going forward.

Recycling The medical plastics sector does have ‘single-use’ at its core. And with good reason.

talking

POINT

www.medicalplasticsnews.com

Read all about it: MPN North America MPN North America is a year old.

If you’re based in that region, subscription is free.

DIGITAL SPY

University footage shows bug-killing effects of silver-treated surfaces

E

www.biocote.com

xperts at the University of Warwick have produced microscopic footage of the potentially deadly E. coli bacteria being wiped out in just two hours on an antimicrobial treated ‘intelligent’ surface.

Dr. Antonia Sagona created revealing time-lapse imaging featuring fluorescently labelled bacteria, to bring to life the effects of silver-treated surfaces compared with a non-protected surface.

severe, sometimes deadly, infections like septicaemia and pneumonia.

Neither can invasive fungi or viruses such as H1N1 influenza and derivatives like the virulent Aussie strain.

These ‘invisible’ silver ion additives are simply integrated into everyday products at the time of manufacture.

What’s the difference between MPN Europe and MPN North America?

With MPN Europe going strong we began to recognise the growing number of North American readers and decided to offer a dedicated magazine for that region.

The new publication has been up and running for a year now and has built on its close relationship with its US audience offering a publication specifically for that region – its news, its innovation, thoughtleadership and medical plastics expertise.

Why should I read this publication?

Since its launch in 2017, Medical Plastics News North America has secured its place as a market-leading information source for the medical plastic and device sectors.

MPN North America provides a multi-platform hub for anyone working in or targeting this sector. It is a place to discuss, promote and learn. With quality readers – senior decision-makers from the world’s leading OEMs – it offers increased opportunities for readers and advertisers to communicate with the wider medical device industry.

The data was obtained at optimal bacterial growth temperature and the footage showed that bacteria thrive on an untreated surface. The footage also showed that on a BioCote-treated surface they die quickly.

Nasty microbes cannot survive on BioCote treated surfaces, which the company says is scientifically proven to destroy up to 99.99% of harmful bacteria. This includes superbugs like the flesh eating MRSA that can result from surgical wound complications, Campylobacter which is potentially fatal and the most common cause of food poisoning in the UK, plus Salmonella which can cause

Where can I get it?

The title is available at key industry events, such as MD&M West and East, and through our website www.medicalplasticsnews.com.

WWW.MEDICALPLASTICSNEWS.COM

9

STERIS Vaporized Hydrogen Peroxide (VHP) technology is your solution to low-temperature (+28‌40 °C) surface sterilization needs.

STERIS being the only company that can provide VHP technology for both material transfer and terminal sterilization, you can trust the VHP DC-A material transfer chambers and VHP LTS-V low temperature terminal surface sterilizers to improve products sterility, manufacturing quality and efficacy in aseptic manufacturing process.

STERIS VHP DC-A

Learn more about these products and our VHP technology at www.sterislifesciences.com

STERIS VHP LTS-V

NEWS FOCUS

A

Can Scotland achieve its life science potential?

report in the The Scotsman asks whether Scotland has been underselling itself when it comes to the life science sector.

Scotland has much to offer the global life science sector.

So why are we hearing that it’s not reaching its potential?

Industry leaders feel that Scotland is ‘missing a trick in not selling itself abroad’, writes David Lee. Scotland could a global player abroad and this says Lee, means three things: Making Scotland a go-to location for global life science companies; creating an international mindset and using networks to drive business development and create international SMEs.

Life Sciences in Scotland says the country is one of the largest life science clusters in Europe, employing over 37,000 people in around 700 companies – these business contribute over £2.4 billion turnover to the Scottish economy.

Earlier this year the Life Science Scotland Industry Leadership Group launched a new strategy to help the sector reach £8 billion by 2025.

Dave Tudor, industry chairman of Life Sciences Scotland, told the BBC: “This is an exciting time for life sciences businesses in Scotland. I am delighted with the shape of our refreshed strategy and the strategic themes that have been identified.

“We now need focus and alignment from across the sector as we create the working groups that will plan and coordinate the delivery of this strategy. I look forward to working with everyone to ensure success in the future.”

The Scottish Life Sciences Association (SLA) represents 130 companies. Its helps attract investment and engage with the NHS and

government to grow the sector in the country.

Speaking to The Scotsman, Scott Johnstone, chief executive of SLA, said Scotland does have some smaller exciting global players: “If you have the desire and the savvy, you can do it from Scotland.”

Professor Pete Downes, principal of Dundee University feels the issue might be bigger.

“There is not one centre in Scotland big enough to be truly world-class, compared to California or Boston. It’s not just university research, but all the components of a functioning innovation ecosystem for life sciences. You need a dozen universities in that space and huge investment for business and industry. We might have to think of ourselves not just as a Scottish cluster, but a UK cluster,” he said.

The UK has a leading position in the life science sector. Government figures say that it represents 0.9% of the global population but produces 15.2% of the world’s most highlycited articles. Research in this sector is twice as great as the US and nearly three times as great as Germany. Adding Scottish expertise into this mix could boost opportunities. When we read about UK life sciences, invariably it is the London-Oxford-Cambridge triangle that is singled out. The North West of England and Wales are just two UK regions that boast strong life science knowledge so part of the problem maybe that Scotland is being overlooked due to a particular region having historical significance.

So, what does Scotland need in order to become a world player? Russell Jackson asked this question in The Scotsman. Ken Sutherland, president, Toshiba Medical Visualization Systems, said: “We see substantial opportunities in the new Life Sciences Strategy for Scotland because we want to grow our business here and deliver more innovation to the global healthcare market through our parent company in Japan.

WWW.MEDICALPLASTICSNEWS.COM

“We see Scotland gaining credibility as a preferred location for life sciences companies and academic researchers and this increased momentum for the sector in Scotland will help us to attract and retain the super-talented people we need to drive our business forward. The focus on life sciences and healthcare innovation from both Scottish and UK governments and the willingness of NHS Scotland to engage with industry will also help us to bring more global R&D to Scotland and the development of new SMEs and scale-ups will give us new opportunities for collaboration and access to innovation.”

Pawel de Sternberg Stojalowski, managing director, Aseptium, which develops new products for medical device decontamination, told Jackson: “Here, as in most life sciences, new solutions are found based on scientific research and cross-industry collaboration. This happens because most complex problems affect various disciplines and require different disciplines of science and engineering to work together. It is this ease of access to wide expertise that makes Scotland special. You create environments for testing ideas. This was the main reason for bringing Aseptium to Inverness: we met people keen to share resources, knowledge and open doors that made development of our technologies quicker.

All we need to do is to work closer together. “

There is not one centre in Scotland big enough to be truly world-class, Pete Downes, Dundee University

11

Brilliant performance | ENGEL medical

ENGEL medical Fully-electric machines impress with great performance. The ENGEL e-motion medical series combines best-of-class performance with maximum cleanliness.

Optimised for clean room applications, the machine has an encapsulated barrel to minimize particle and heat load, along with encapsulated injection unit drives and an oil return unit on the toggle lever as standard features. The ENGEL e-motion medical is available as a continuous series with up to 500 tonnes clamping force.

Clean and precise. With ENGEL medical. Because it is about life.

www.engelglobal.com

NEWS FOCUS

A

Industry 4.0 and medical manufacturing – friend or foe?

s the age of the fourth industrial revolution progresses, Industry 4.0, the Internet of Things (IoT), operational excellence, smart manufacturing and connected data are industry developments Industry 4.0 is that are becoming increasingly important to a buzzword in the continued success and competitiveness the industry at of today’s global manufacturer.

the moment.

Amir Aloni, LeaderMES examines how this next industrial revolution will impact medical maufacturing

Today, Industry 4.0 technologies enable manufacturers to have full visibility of operations and allow them to not only be responsive at a much higher level to information about raw materials, inventory, assets, quality, waste, output and customer demands but to also become proactive.

Across most industries, such visibility ensures that opportunities for improvement are highlighted so that action can be taken to save money, time and improve customer satisfaction and supplier relations. To compete effectively in the everchanging global marketplace, manufacturers have to take full advantage of this technology.

Questions have been raised whether the Industry 4.0 paradigm could conflict with medical manufacturing practices. For example, Industry 4.0 practices strongly encourage closed-loop feedback systems, where smart machines allow for decision-making during the manufacturing process, adjusting alignment of machines, changing speeds, etc. This may create a conflict with the medical industry practice of validating and verifying processes and controls.

Experience shows, however, that manufacturing in the medical industry can greatly benefit from implementing Industry 4.0 practices. In this highly-regulated sector, quality control, traceability and compliance are crucial for ensuring success and even survival in the market. The huge amount of data that can be collected from manufacturing lines contains a great deal of information that should be used for quality assurance measures. As data integrity is high on the

priority list of regulators, it can only be secured by having a single, secure source of facts.

Traceability and control over the manufacturing process, as well as compliance with regulations and standards, provide medical manufacturers with the benefit of offering their customers high quality products and meticulous service, which play significant roles in a company’s overall competitiveness.

Making Industry 4.0 work in medical manufacturing LeaderMES facilitates industrial SMEs to shift to an Industry 4.0 paradigm by enabling operation intelligence throughout the manufacturing journey, powered by the latest in secure connectivity, data analytics and advanced computing. By optimising production efficiency and digitally streamlining processes, users can benefit from the most advanced industrial technology, increasing their profitability and competitiveness.

LeaderMES offers a smart digital manufacturing platform that provides a comprehensive manufacturing management system together with the flexibility of modular plug-andplay tools. The secure, cloud-based, digital platform and smart applications provide visibility and control in highly demanding production environments. The implementation of the technology at a medical device manufacturer may offer a glimpse into the benefits of Industry 4.0 practices in medical manufacturing.

Questions have been raised whether the Industry 4.0 paradigm could conflict with medical manufacturing practices.

WWW.MEDICALPLASTICSNEWS.COM

13

Specialist Kit Components Custom Made for You Does your new product need bespoke plastic kit components?

We can help with our personalised, flexible, efficient custom-design service for:

Pastette® Disposable transfer pipettes in any format

Hydrophilic Coating W O R K W I T H T H E E X P E R T S TM

NEW!

• Customization of formula to meet your performance requirements • Low particulate count* (meets USP 788 standards) • Biocompatibility • Shelf life stability* to help you mange cost and supply challenges • Proven coating and substrate adherence • Fully-automated coating application technology and curing process

Ireland | USA Let’s get to work on your project Phone: +353.61.331906 E-mail: oeminfo@teleflex.com Web: www.teleflexmedicaloem.com

Plate Seals For specific manufacturing and packaging requirements

UN3373 Compliant Packaging Custom designed kits for clinical trials packs and diagnostic kits.

You define the specifications, size, branding and packaging Contact Alpha Laboratories for more information or a quotation for your OEM requirements and join our long list of satisfied customers.

Visit www.alphalabs.co.uk, call +44 (0)23 8048 3000 or email marketing@alphalabs.co.uk

©2018 Teleflex Incorporated. All rights reserved. Teleflex and “Work With The Experts” are trademarks or registered trademarks of Teleflex Incorporated in the U.S. and/or other countries. *Note: Data on file.

14

W W W . M E D I C A L PMPN_adv_86x265mm_Oct2017.indd L A S T I C S N E W S . C O M3

11/10/2017 10:31:57

NEWS ANALYSIS

Are your suppliers ISO-ready?

With new requirements on quality management for medical devices set for March 2019, FMI asks how OEMs can recognise whether suppliers will achieve certification on time?

M

edical device manufacturers are responsible for ensuring that all components, even ones produced externally, comply with all relevant ISO guidelines. To this end, they must check and ensure that the quality management systems of their suppliers fulfil all the necessary requirements. This is all the more urgent now as two crucial standards have recently been revised: Suppliers must ensure that their processes conform to the new EN ISO 9001

by September 2018 and to the revised EN ISO 13485 by March 2019.

“For OEMs, it is not always easy to ensure that vendor parts conform to ISO standards,” explained Leo Gelera, quality manager at FMI. “In the best case scenario, the quality management systems of our suppliers are efficient enough to recognise risks and prevent faults and defects.”

deadlines for certifications according to these revised standards. In order to complete the certification process successfully within the deadline, the supplier can engage an external consultant or use internal personnel resources. If the latter approach is chosen, the office responsible for the certification should be contacted.

This office will provide advice on the best process and provide the checklists, which are also used for later evaluation. In addition, the quality manager responsible for the project should attend a training session about the requirements of the new standards and be certified as the lead auditor. If this occurs, the next step is to carry out a gap analysis.

In doing so, the requirements of the new guidelines are compared with the current processes at the supplier’s premises and steps for their adjustment are identified.

The medical device manufacturer recognises how effective the internal processes are using factors such as certification as per ISO standards, risk management for product realisation, the use of a Corrective and Preventive Actions (CAPA) programme and the significance of quality as part of the corporate culture.

Pressing deadline

Certification according to revised standards essential

For example, FMI carried out a gap analysis back on January, 2017 and identified the areas, in which changes are needed. “In my view, the key elements of ISO 13485:2016 are the training and CAPA programme along with more accurate supplier checks,” says the quality manager.

The priority for OEMs at the moment is to ensure that suppliers comply with the

“The companies should not dawdle. The regulatory bodies are allowing the exact amount of time required for successful certification between the publication of the standard and the end of the deadline,” highlighted Gelera.

WWW.MEDICALPLASTICSNEWS.COM

“We are making major progress in these areas, for example we have redefined our training program to include a more robust verification check to ensure that FMI’s training plans for our employees are effective.”

FMI has already agreed an evaluation date in April 2018 with the certifying authority. Even if not all the companies in the supply industry are working as quickly, the gap analysis at least needs to have been performed in September 2017 and a precise plan for the upgrade should have been developed.

“There can be grave consequences for an OEM if it obtains components from a company, whose quality management system is not certified in accordance with ISO 13485:2016,” said Gelera.

“This certification is a fundamental prerequisite for being able to market a medical device in the European Union. As a result, it is one of the standard requirements of suppliers for many OEMs.” If the deadline is not complied with, the medical device manufacturer must not use these components in its production processes until the non-compliance is resolved. As OEMs normally only have one supplier for a specific component, there is the risk that existing orders might not be fulfilled.

If the medical device manufacturer has the impression that its supplier is not currently far enough into the certification process, the OEM should at least request the supplier’s action plan and schedule for the adjustments in order to get a more accurate overview and be able to take action in good time.

15

POLYMERS FOR DRUG DELIVERY OUR MEDICAL PORTFOLIO:

FIND OUT MORE VELOX.COM

· Barrier polymers · Polymers for primary & secondary drug packaging · Flexible & rigid polymers

7 – 8 FEBRUARY 2018 Paris, France Hall 7.1 · D64

VELOX GMBH +49 (0)40 369 688 0 medical@velox.com

EXHIBITION & CONFERENCE 7-8 FEBRUARY 2018 PARIS EXPO, PORTE DE VERSAILLES

WE ARE EXHIBITING AT PHARMAPACK 2018 AND WOULD LIKE TO SEE YOU THERE!

NOUS SERONS À L’EXPOSITION PHARMAPACK 2018

• Innovation Gallery • Pharmapack Awards • Innovation Tours • Pharmapack Start-up Hub

EDUCATION

INNOVATION

NETWORKING

ET SERIONS RAVIS DE VOUS Y RENCONTRER !

• Networking Areas & Events

• International Meetings Programme

• Conference • Symposium • Workshops • Learning Lab

#PharmapackEU

ENGINEERING EXPERTISE IN ELASTOMERS FOR YOUR PHARMACEUTICAL PACKAGING

Visit us at Pharmapack Paris!

2K and Multi Component Parts Liquid Silicone and Rubber Parts

Extrusion of Complex and Micro Tubes Coating

You can find us here: Hall 7.1, Stand L13 and M18 7. – 8. February 2018 | Paris Expo, Porte de Versailles Find more information at www.trelleborg-lifesciences.com

TRELLEBORG SE ALING SOLUTIONS

16

WWW.MEDICALPLASTICSNEWS.COM

Molding Micro-Molding

NEWS ANALYSIS

Computer simulation is an important aspect of medical device development, and the technology has been developed to simulate human physiology

Dassault Systèmes’ Living Heart project not only puts a new perspective on medical research but also provides a valuable tool for medical device manufacturers

I

n the United States, someone has a heart attack every 34 seconds. While stents, transplants, angioplasty, by-pass operations, drugs and improved patient care have dramatically cut deaths from heart disease, it remains the number one killer. The World Health Organisation estimates that the disease globally accounts for one in three deaths.

Computer simulation is already an important aspect of medical device development, and it is only in recent years that the technology has been developed to such an extent that it can now simulate human physiology.

Recently technology companies have been teaming up with doctors and clinicians specialising in biomechanics to replicate individual hearts in a virtual reality.

simultaneously using the simulated heart rather than one at a time, dramatically lowering barriers to innovation and reducing time and cost.

The Living Heart model includes the well-defined anatomic details of the heart including valves, arteries, papillary muscles and electrical fiber network. Further it includes proximal vasculature, such as the aortic arch, pulmonary artery, and superior vena cava (SVC). The dynamic response of the heart model is governed by realistic electrical, structural, and fluid (blood) flow physics.

INFLUENCE OF DEVICES ON HEART FUNCTION SIMULATION

Dassault Systèmes recently outlined multiple milestones in its Living Heart project aimed at driving the creation and use of simulated 3D personalised hearts in the treatment, diagnosis and prevention of heart diseases. As the scientific and medical community seeks faster and more targeted ways to improve patient care, the Living Heart Project is extending its reach through new partnerships and applications while lowering the barriers to access.

Dassault Systèmes has been involved in many simulation projects over the years – from automobile design simulations that help avoid serious injury, to studies of the impact of contact sports on the brain. The Living Heart Project is connecting numerous great minds in cardiovascular modeling and simulation to solve the toughest challenges, and delivering ready-to-use human models in the process.

SIMULTANEOUS TESTS IN THE CLOUD The Living Heart is now available through the 3DExperience platform on the cloud, offering the speed and flexibility of highperformance computing (HPC) to even the smallest medical device companies. Any life sciences company can immediately access a complete, on-demand HPC environment to scale up virtual testing securely and collaboratively while managing infrastructure costs. This also crosses an important boundary toward the use of the Living Heart directly in a clinical setting.

With the move of the Living Heart to the cloud, effectively an unlimited number of tests of a new design can be carried out

The Living Heart model represents a completely functioning baseline of a healthy heart, which can be used to then study congenital defects or introduce disease by modifying the shape and tissue properties in an easy-to-use software editor. More importantly, medical devices can be inserted into the simulator to study their influence on cardiac function, validate their efficacy, predict reliability under a real-world range of operating conditions, and even anticipate long-term tissue regrowth and remodelling effects.

Existing devices such as coronary stents can be evaluated for optimal type, size, and placement location to achieve the best performance, while innovations such as leadless pacemakers can be designed and tested in a physically realistic virtual patient, dramatically reducing the design-test cycle time and cost.

For the first time, the Living Heart was used to simulate detailed drug interactions affecting the entire organ function. Researchers at Stanford University working with UberCloud recently used the Living Heart as a platform for a model that would enable pharmaceutical companies to test drugs for the risk of inducing cardiac arrhythmias, the leading negative side effect preventing FDA approval.

“The Living Heart Project is a strategic part of a broader effort

by Dassault Systèmes to leverage its advanced simulation applications to push the boundaries of science,” said Jean Colombel, vice president life sciences, Dassault Systèmes.

“By creating both a community and a transformational platform we are beginning to see the advances from the Living Heart Project being used for additional aspects of cardiovascular research as well as for other parts of the body, for example the brain, the spine, the foot, and the eye, to reach new frontiers in patient care.”

WWW.MEDICALPLASTICSNEWS.COM

17

OPINION

Increasingly, polymers replace glass, metal and other traditional materials used in medical and pharmaceutical devices Photo: © TOPAS

Want to know the pains and pitfalls of polymers in medical devices?

Anja Flossbach, Velox. explains what is at stake when it comes to the right material choice for the development of medical and pharmaceutical devices

T

he use of polymers in medical devices has been growing steadily over the last years, replacing glass, metal and other conventional materials.

However, when it comes to the right choice of polymer, some pains and pitfalls have to be taken into consideration.

Anja Flossbach, Velox, knows what matters when it comes to the right material for medical and pharmaceutical applications.

The right choice of material is crucial for developers to succeed when it comes to compliance regulations

18

“The development of medical and pharmaceutical devices takes time and money and is strictly regulated”, says Anja Flossbach, mechanical engineer and business development manager, medical plastics, at Velox. “Therefore, the right choice of material is crucial for developers to succeed when it comes to compliance regulations, certification processes and, most importantly, providing a high-quality product.”

There are at least five criteria that have to be evaluated thoroughly when selecting materials for specific medical or pharmaceutical applications. “On the one hand, of course, one has to consider the manufacturer’s design and application specifications”, says Flossbach. “On the other hand, the material properties are key aspects to be scrutinised with regard to these specifications.

And last but not least, pricing as well as regulatory and handling aspects are critical for the products’ successful realisation and market entry.”

Preventing colour change and breakage Housings for diagnostic and monitoring equipment for hospitals, for instance, often have to withstand highly aggressive and concentrated cleaning agents. This can cause stress cracking in the plastics, which may lead to fluids penetrating into the medical device, damaging the often expensive electronics. Hence, it is crucial to use the right material.

“Upon examining the application specifications, we might introduce a polycarbonate/polyethylene terephthalate (PC/PET) for hospital equipment, whereas acrylonitrile butadiene styrene (ABS) or PC/ABS could be considered for homecare devices, where less

aggressive cleaning agents are typically used,” explains Flossbach.

Similarly, different polymers may react differently when it comes to the sterilisation of medical devices. To avoid colour change or loss of mechanical properties in processes like steam sterilisation, materials have to be particularly resistant, notably to high temperatures.

The right TPU for medical implants Another example are implantable materials. Many medical-grade polymer suppliers do not allow the implantation of their materials into the body, or restrict it to particular time limits, typically 24 hours or 30 days.

Nevertheless, there are material options for long-term implant applications (medical device classification 2a or higher).

“Our partner Lubrizol does not restrict the use of their TPUs to 30 day implants. Device designers are free to select from a wide TPU portfolio the most suitable grades to be tested and considered for each specific application,” she says.

Medical compounds: what’s in them?

Regulatory approval of customised compounds is another issue that can be difficult to handle if the device manufacturer does not have full transparency on the compound. Therefore, it is appreciated if the compounder provides full transparency about the formula of the compound. Velox’s partner IPC, for instance, who develops tailored compounds for medical applications, discloses compound formulae on the certificate of analysis.

Cooperation from the early design stage “To really add value for our customers and help them choose the right material for their specific application, at Velox we focus on technical assistance and engineering support by working with our customers from a very early design stage,” highlights Flossbach.

WWW.MEDICALPLASTICSNEWS.COM

PROVEN PERFORMANCE. TRUSTED

EXPERTISE We offer functional, reliable solutions to solve the biggest challenges in healthcare and medical device applications.

Our industry leading quality, material reliability, technical and regulatory expertise helps you advance through material science innovation.

Our broad portfolio of safe, durable and reliable solutions, includes: • Pressure sensitive adhesives • Soft-skin adhesives • Curable adhesives • Lubrication and siliconization • Medical grade rubber and elastomers • Device adhesion materials • Biopharma tubing • Selective adhesion solutions • Liquid silicone rubbers Learn more at www.dowcorning.com/healthcare ®™The DOW Diamond Logo is a trademark of The Dow Chemical Company © 2017

OPINION

I

t’s no secret that the medical devices sector is undergoing rapid change. As governments and health insurers look to control costs, hospitals and healthcare providers must maintain service levels with smaller budgets. These measures are transforming the purchasing process which in turn is changing the way that medical products are bought and sold.

Purchase decisions that used to be the sole responsibility of doctors are now also made by regulators, procurement teams, hospital administrators, and other non-clinicians. This shift has been met with both a mix of reservation and appreciation. On one hand it takes the hassle out of purchasing equipment for a clinician, on the other it means that sellers must now address a multidisciplinary group of purchase influencers with differing objectives.

This broader mix of influencers means that selling medical devices is now an increasingly complex process. Where once the salesperson would rely on technical language and detailed feature knowledge to sell to a clinician, who naturally understands the product in question, now that same salesperson must sell to a range of stakeholders - including savvy negotiators, trained in the art of striking a deal, without perhaps the same level of technical knowledge as their predecessors.

The result? A radically different sales approach is needed and an acknowledgement that we’re definitely not in Kansas anymore. The days of one on one feature selling are over. Salespeople must get to know their buying decision making unit; know who’s in it, what their individual goals are from the purchase, what level of influence do they have and then address each accordingly.

20

David Freedman, director at sales and negotiation specialists, Huthwaite International, the team behind SPIN Selling, and sales trainer to some of the biggest medical device companies in the world, outlines five of the major steps that can help to secure that tricky medical devices sale, using the methodology applied by 30% of the UK’s Forbes 100 companies.

Despite the changes in the selling landscape in the medical devices sector, the fundamentals of selling universally remain unchanged; ‘I want you to buy what I have to sell’. The trickier element is convincing the individual that they not only want your product, but they need it. Historically for the sector this was in some ways an easy task.

Clinician’s knew what they needed, where to purchase and who to place an order with to strike a good deal. Medical device sales staff spoke the same language as their customers – with technical terminology often used as common place.

With a new, more diverse audience to now convince to purchase, medical device salespeople need to adopt a new approach.

The problem is, the medical device sector is now selling to, amongst others, negotiation professionals – a notoriously tough bunch to crack. Whilst the sales professionals themselves WWW.MEDICALPLASTICSNEWS.COM

may be proficient in technical product knowledge, buyers often boast heavy weight negotiation experience that can price sellers out of the market looking to undercut on deals and place mass orders.

So, what does this mean for sellers? Drawing on the SPIN Selling technique, sales people in the medical devices sector can learn valuable lessons when it comes to appealing to their audience – primarily that their customer isn’t interested in a product, they’re interested in their own problem and finding a solution to it. In short; my clinician requires this device, they understand its benefits because of x, y and z and have a good insight into how much investment is required into said product. Today it’s a very different story – not everyone in the DMU understands the technical terminology around specific devices, nor do they always fully appreciate the advantages of a device’s specific features. They are focused on a wider set of attributes including price, logistics, ease and quality of product. Once a core sales technique, technical details and features are proportionally far less important.

With this in mind, it is essential that sales professionals take a more strategic approach to selling. Below are five critical techniques and considerations that can help to create a more effective sales environment:

OPINION

Huthwaite International is a global provider of sales, negotiation and communication skills’ development. The company’s Neil Clothier explains five ways to help secure a sale

EXPERT ADVICE ON HOW TO SECURE A DEAL

01

02

03

04

05

ASK QUESTIONS AND APPLY YOUR RESEARCH

FIND THE ANSWERS YOU NEED

LISTEN TO YOUR CUSTOMER

AGREE A MEANINGFUL NEXT STEP

DON’T IMMEDIATELY MAKE A COUNTERPROPOSAL

By asking questions that open discussion around the challenges the client is facing, you can position yourself as a helpful adviser and problem solver. In this case it’s important to understand the brief the procurement team has been given. Are they looking to buy in bulk, what are the key features, how can you communicate this in a straightforward way? This also helps you to steer the conversation – meaning you can apply your research findings and start to build a valuable rapport with the client, in turn this will help to differentiate you from those still adopting the more oldschool approach to sales in the sector.

While asking clients questions is better than simply talking ‘at’ them about your device’s features, our research shows successful salespeople ask more of certain types of questions.

Situation questions are used to uncover the facts and background of the customer’s existing situation, for example, the type of patients a device needs to serve, or what locations they are based in. Problem questions are about customer’s problems, difficulties and dissatisfactions. They identify whether or not something is a problem and should also be used to clarify that problem, for example, how satisfied are they with their present equipment? Or where does the problem happen?

Our YouGov research found 85% of business decision makers believe a good buying experience involves a salesperson listening carefully to their requirements. This shows a desire on the customer’s behalf to be heard by the salesperson. And if salespeople aren’t listening, it means they’re talking; usually about the equipment or device they are looking to sell. This is a real danger as it’s a missed opportunity to discover how you could help your customer. Sellers must be careful not to be caught up in the excitement of talking about the bells and whistles of their device.

In a major sale, clients are seldom likely to order something or decide ‘no sale’ immediately; next steps are likely to be what we call Advances or Continuations.

An Advance is when a customer commits to take action that moves the sale forward by providing access to a new, meaningful resource. A continuation, on the other hand, is when the customer doesn’t commit to doing anything, but the seller may have to do a lot.

We consider Advances to be successful, but Continuations not to be. Successful sellers look for the highest realistic commitment they can get from each interaction to continue in the sales cycle.

Negotiating terms is standard in any sale, but it can be a potential minefield.

A finding from our research is that skilled negotiators are less likely to make a counterproposal than the average negotiator.

Responding with an immediate alternative to the one proposed by the client often gives the impression that you aren’t listening to your customer’s needs.

Successful negotiators concentrate on exploring the underlying causes for the client making their proposal, so that they can discover their customer’s true objections.

WWW.MEDICALPLASTICSNEWS.COM

21

COVER STORY

Living the dream How Trinseo polymers help us lead an active life

A

s the healthcare market continues to evolve to meet the needs of patients, providers and our global healthcare system, self-administered therapies are growing in popularity. This is due to a number of factors: The desire to drive healthcare costs down; the emphasis on improving the quality of medical therapies, and the emphasis on treating chronic conditions at home to accommodate patients who want to self-administer treatment and continue their active lifestyles.

Drug delivery devices, also known as combination devices, provide the answer to self-administered therapies. Not only are they convenient and easy to use, they offer more precise dosage than the traditional provider-administered method, improving the efficacy of treatment.

The drug delivery devices market is segmented eg. nasal, oral, transdermal, topical and ocular. Both traditional medical devices manufacturers and pharmaceutical companies are involved in bringing the devices to market with medical device companies incorporating pharmaceuticals into portable housings, and pharmaceutical companies encasing their therapies.

A common concern of these manufacturers is being able to offer their customers – healthcare professionals and the patient – drug delivery devices that are effective therapeutically and safe, and offer functionality, convenience, haptics and aesthetics. This applies to all sorts of devices including auto injectors, insulin pens, inhalers, prefilled syringes and wearables, and is vital to ensuring patient use of the often lifesaving devices.

Polymers provide a solution One of the key considerations in balancing therapeutic effectiveness and safety with functionality, convenience, haptics and aesthetics is the material that goes into the application. Polymers have provided an important solution to the marketplace in that they offer characteristics such as portability, durability and appealing aesthetics which can result in overall patient acceptance.

Typical materials for drug delivery devices include acrylonitrile butadiene styrene (ABS) and a polycarbonate (PC) blend; PC/ABS for housings, transparent ABS and PC for windows; polystyrene (PS) for secondary packaging; PC that can be sterilized for needle caps, and soft thermoplastic elastomers (TPEs) for comfort grips. Each one of these materials can be customised to meet the specifications of an application delivering critical properties such as: • High impact resistance and stiffness • Styling and appearance • Fatigue resistance • Chemical resistance • Low coefficient of friction and resistance to wear A thorough understanding is key Ideally, polymers should be selected upfront, when an application is being designed. It is important at this stage to gain an understanding of how a device will be used. This will prevent delays in commercialising the device and provide the best chance of patient acceptance when the device is finally introduced to the market. What are the needs of the patient?

22

What are their demographics? What are the stages of proper functionality? How will the patient prepare the device? How will he or she administer the dose? How will the device be disposed? All of these questions are important to determine the best material solution.

From an aesthetic perspective, consider a property such as colour. This can address a number of usability and acceptance issues, not only making devices more attractive but also providing important indicators of function. Colour has long been known to impact emotions. While bright, vivid colors can tend to be attractive and invigorating, cooler colors such as blue and green, have a calming effect. This is important to remember, especially when considering somewhat stressful activities as self-injection.

Colour can alert a patient to proper functionality, or the correct way to administer a therapy. For example, what is the top of the device; what is the bottom? Opposing colours can provide this clue. Instructions can also be indexed with colour to ensure

WWW.MEDICALPLASTICSNEWS.COM

COVER STORY

proper understanding. It is important to minimise error in drug administration to avoid dosage problems and risks to patient safety.

Colour can be a big help in this area.

The challenge when considering colour is to create parts in their ‘true’ colours, consistently. Trinseo offers a solution with its, Magnum ABS resins, which are produced using the company’s proprietary mass polymerisation technology, rather than the usual emulsion process. This method of production results in exceptional whiteness in base resins which is ideal for colouring. It also results in superior lot-to-lot consistency, excellent processability and lower residual monomers and oligomers.

Whether pure ABS is used or if it is blended with polycarbonate, the Trinseo material provides the advantages that mass polymerisation offers. Colouring also can be a big expense. Those who have used Magnum ABS resins have experienced significant cost savings on colouring due to less pigment required, while increasing efficiency, yielding richer colours, and enabling a wider range of appearance options.

Breakdown of a drug delivery device When selecting materials, it is important to analyse the various parts of a device to determine materials needed. Following is an example of a breakdown of one of the most common devices, an auto-injector pen.

A materials supplier can specially engineer resins to meet application requirements, considering regulatory requirements and global harmonisation objectives, to help plan for cost-effective production. The intricacy of this particular device highlights the importance of considering the total device upfront to make sure all areas of the device are considered and parts are consolidated where possible.

A breakdown of an auto-injector pen: Upper casing and parts • Depending on the requirements for stiffness and aesthetics, ABS resins or ABS compounded with polycarbonate can be ideal for application areas ranging from outer housings to internal components. If colour is a consideration, mass polymerisation ABS, such as that offered in Trinseo’s Magnum ABS resins, should be considered resulting in exceptional whiteness and lot-to-lot consistency. The material can also meet the typical requirements of biocompatibility and sterilisability. Adding PC to the ABS enhances the material with physical properties of polycarbonate while maintaining the processability, toughness and flow of ABS. Internal components

Trinseo explains how polymers are boosting quality in drug delivery devices, enabling patients to lead an active lifestyle

• The internal mechanics can be made from a variety of materials. Typical applications may call for polycarbonate resins that offer durability, biocompatibility, and/or transparency. Glass-filled polycarbonate resins can be used for parts requiring enhanced stiffness. Trinseo, for example, offers a glass-filled polycarbonate, its Calibre 5000 series, with glass content of up to 30% while maintaining biocompatibility. Polycarbonate resins can also feature colour compensation technology, such as Trinseo’s Calibre Megarad, for applications needing to be sterilised with gamma radiation Lower casing including needle caps • Similar to the upper casing, depending on the requirements for stiffness and aesthetics, an ABS resin or an ABS compounded with polycarbonate can be used for the lower casing. Polycarbonate resins with colour compensation technology, such as Calibre Megarad, can be used for needle caps requiring sterilisation as well.

Packaging

Growth in drug delivery devices One of the fastest growing areas in drug delivery devices is self injectables. This trend began as a market in the early 1980s with applications including auto-injectors, pens and prefilled syringes.

Due to the efficacy of injectables, there are more injectable drugs in the pipeline than oral medications.

Another area to keep an eye on is wearable injectors. As patients receive at-home treatments for a longer duration, they need to rely on items such as patch devices, prefilled cartridges, controlled injections, and wearables that can be worn for infusions from five to 10 minutes.

In the future we’ll see more connectivity. Leveraging expertise from the consumer electronics industry we’ll see connectivity of drug delivery device with the healthcare provider providing the ability to monitor, evaluate and manage therapies remotely.

• Polystyrene resins are ideal for secondary packaging applications.

If medical certification is needed to reduce risk, a general purpose polystyrene with biocompatibility, specifically for the market, might be considered. Trinseo has a polystyrene designated Styron MED polystyrene that features the stiffness and chemical resistance of general purpose polystyrene with the advantages of biocompatibility and a medically-focused notification of change of up to three years. When soft touch grips are needed for safety or comfort, a soft thermoplastic polymer can be used to enhance haptics. Earlier this year Trinseo completed the acquisition of API allowing us to offer a strong portfolio of soft-touch polymers that is complementary to its rigid performance plastics.

Summary To create a drug delivery device that stands out, product designers and manufacturers are ensuring their products are distinctive. The material – in this case the plastic – becomes an important factor in projecting a brand through product quality, durability, appearance, and differentiating with flexibility of design, colour, haptics and aesthetics.

When considering a material supplier evaluate production and technical resources. Also consider security of supply, notification of change, and quality certifications, e.g. ISO 13485 to help lower risk of non-compliance and increase speed to market. Drug delivery device development can be a long process, a supplier that’s a partner can be a big plus.

WWW.MEDICALPLASTICSNEWS.COM

23

Polyolefin Primer/Adhesive meliflex elastomer and polymer+ compounds dedicated to healthcare

Quality created for added value

X21Med passes ISO 10993-5 test for non-cytotoxicity

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

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

www.masterbond.com

MELITEK A/S Hartvig Jensensvej 1 DK-4840 Nr. Alslev Denmark Tel. +45 70 250 255 sales@melitek.com www.melitek.com melitek @melitek.com

meet us at Pharmapack 2018 Stand B47 February 7-8 Paris - France Medtec 2018 Stand 9E10 April 17-19 Stuttgart - Germany

Design, Develop & Deliver with Distrupol’s range of medical polymers

+44(0)1932 566033 info@distrupol.com www.distrupol.com

24

W W W . M E D I C A L P8464 L ADistrupol S T I C Advert S N E -W S.COM Medical Plastic News - Q1 2016-Final.indd 1

24/03/2016 09:33

THE YEAR AHEAD

The way a device is used, is held, is unwrapped from its packaging, how the patient feels about using it – all this feeds into how and whether a medicine is taken properly. If device and drug companies can unite to create products that work well for the patient, they are one step ahead of their competitors.

Lu Rahman highlights some of the key trends in store for the medical plastics sector in 2018

I

t’s always interesting to take a view on what lies ahead for the medical device sector. Last year we heard rumours that Trump was considering disbanding the FDA in the US as the country – and the rest of the world – wondered what the eventual outcome would be for the medical device tax.

While debate still continues over the tax, in terms of the manufacturing environment, there are some standout trends that we’re still eyeing with interest.

As we continue to age and contract illnesses, the medical device market remains strong. Conditions such as asthma show no signs of abating – revenue from the global respiratory inhaler devices market is set to surpass $44 billion in 2017, according to Future Market Insights – meaning we have a continual need for devices.

Opportunities also exist for teamwork within the packaging sector. Looking at biologics again – these drugs can require specific storage conditions which can affect packaging. By working closely with pharmaceutical companies, medical packaging experts can benefit from expert knowledge to create products that meet stringent pharma guidelines.

Making a digital connection Just as pharma and medtech are becoming increasingly intertwined, the digital health sector feeds into this.

Connected devices continue to be big business. What’s really interesting is the way that pharma is talking to the device manufacturer, who is looking to advances in sensors and technology. Not only does this create devices that are connected (benefitting the healthcare professional and the patient) but it also offers pharmaceutical companies access to information on patient adherence.

More and more pharma companies are showing an interest in the digital health market, in devices and technology that can help them evaluate the usefulness of how drugs are taken and how that impacts on the health of the population.

Digital solutions cover a range of application. In recent months the term ‘distance health’ has edged onto the scene. I’m always interested in what comes out of Cleveland Clinic and this term has been highlighted there as holding significance in the year ahead.

Cleveland Clinic’s, Michael Roizin, said: “Due to an increase in connectivity through mobile technology and consumer demand, hospitals are getting ready for widespread adoption in 2018.

90 percent of healthcare executives reported to have or are currently building a telehealth program. Reports also predict seven million patient users in 2018, a 19-fold increase from 2013.

“These technologies are also expanding beyond the simple two-way video platform. More patients are now equipped with attachable devices that record and report medical information to doctors to monitor their condition.

Over 19 million patients are projected to use these remote monitoring devices in 2018. With momentum building, the clinic believes that the emergence and acceleration of distance health technologies and services are assured in 2018.”

The market is strong and increasing.

As the population across the globe lives longer, contracts more illnesses and healthcare problems, the need for technological to cope with demand in key.

Collaboration between medtech and pharma Overlap between the pharmaceutical and medical device sectors is growing. Drug delivery is a key sector for medical device manufacturers and suppliers, and the pharmaceutical world. One area being singled out is biologics. According to Grand View Research, this market is set to grow to $399.5 billion by 2025.

With specific issues around delivery (these drugs tend to require higher injection force due to their increased molecule size), biologics offer device manufacturers an opportunity, especially as we see a trend for these products to be administered remotely. This provides pharmaceutical companies and medical device manufactures with the ideal opportunity to work collaboratively and create products that contain expertise from both sectors. Ultimately this means less error in material selection and design, less inefficiency and less time wasted in overall product development.

WWW.MEDICALPLASTICSNEWS.COM

25

Your CDMO for Medical Devices and Complex Pharmaceuticals

Lubrizol LifeSciences is a total solutions provider for medical device manufacturers. We specialize in helping customers by offering innovative materials, ingredients, drug formulation development, and best-in-class contract manufacturing solutions.

How we do it: • Polymers - comprehensive, customized and application-specific medical grade materials • Product Development - development and support of advanced drug delivery solutions • Manufacturing - contract manufacturing for medical devices and components To learn more visit www.lubrizol.com/LifeSciences

© 2017 The Lubrizol Corporation, all rights reserved.

All marks are the property of The Lubrizol Corporation. ™ The Lubrizol Corporation is a Berkshire Hathaway company. 17-0100117-MPN

Links Science to Life

THE YEAR AHEAD

Waste and recyling

Medical tubing prospects continue in 2018

While not necessarily a trend, it’s definitely something we need to seriously address plastic waste. It’s a topic that’s hitting the headlines on a regular basis, particularly in the UK. While most of us would agree that we need to reduce the amount of waste the plastics industry is producing, in the medical plastics sector, this isn’t so straightforward. Certain products need to be single-use for a reason.

Given the applications for many medical plastic devices, and the risk that re-use would pose to health, the argument for throw-away products is evident.

“The global medical device market and healthcare segment in general continues to present new and exciting opportunities for equipment manufacturers. In regions such as India and Asia where countries have large populations and seek to improve the quality of healthcare, this is especially prevalent. Davis-Standard has remained focused on consistency, effective innovation, quality and competitive pricing, which has driven growth for us in 2017 and presents a strong outlook for 2018.

Anesthesiology News recently addressed this issue, pointing out that the, “choice between disposable and reusable airway management devices is more than a question of convenience, requiring consideration of patient- and practicerelated factors as well as economic and environmental issues.”

Dr. Klock, professor of anesthesia and critical care at the University of Chicago, told the newspaper: “The crux of the matter is that we can no longer simply wash laryngoscope handles off after use anymore…We have to go through a formal, high-level disinfection, which is very time-consuming.”

Klock says reusable devices aren’t cheap or easy as they have to undergo a variety of processes before they can be reused. He also outlined how $65,000 was spent on reprocessing single-use laryngoscope handles at the University of Chicago and spending $20,000 per year replacing lost handles and blades. This compares to an estimated $83,000 a year on disposable products if handles were also replaced.

Situations like this mean that single-use products in healthcare are the better option. Cost aside, they avoid the spread of bacteria which is of course, the key priority. Going forward however, we still need to have a discussion on how, even if, medical plastic waste can be reduced.

Devices aside, packaging offers potential for change by having an open and honest industry debate.

Klock says reusable devices aren’t cheap or easy as they have to undergo a variety of processes before they can be reused

One of the primary reasons we’ve maintained market leadership in this extrusion segment is because of our innovation focus and R&D expertise.

Our world-class technical centers in the US, Europe, and China are equipped with medical tubing lines available for customer and product trials. Our lab in Connecticut is set up in a climate-controlled, clean room environment, and we’re able to run coextrusion tubing, single and multilumen tubing, taper and bump tubing, and Alternate Polymer tubing all on the same line.

Offering this capability has been significant, allowing us to continually address our customers demands for tighter tolerance tubing, faster line speeds, and the use of highly engineered materials. It has also enabled us to address high-interest products such as multi-layer embedded radiopaque stripe tubing. Since this tubing is used for diagnostic and interventional procedures involving x-ray imaging, it is very complex. We’ve worked with tooling partners to optimise die design, eliminate burning, and balance the flow of materials used for the stripe to produce a better, more advanced tube. Processes like these involving higher temperature materials such as FEP are always a challenge, but we’re addressing those challenges with the best technology available.

Looking forward, it’s very important to remain innovative and global in approach, regardless of political and economic shifts,” Kevin Dipollino, Davis-Standard Pipe, Profile & Tubing Systems

Orthopaedic market growth “The US Orthopaedic Implants and Device Market is staged for continued growth in 2018 and beyond. Around 28.6 million people in the USA are estimated to sustain some kind of musculoskeletal injury annually according to the Academy of Orthopedic Surgeons, which costs around 254 billion dollars.

As a result, various orthopaedic reconstructive and trauma device manufacturing companies have witnessed continued growth in revenues in the last several years. One of the primary reasons for the rising incidence of various orthopaedic diseases in the US is the growing population of people above 60 years old. These individuals are the largest customers of reconstructive products such as hip, knee and spinal implants in the US (hence, key markets that Modern Plastics is engaged in).

Moreover, younger individuals in their 40s and 50s are also undergoing orthopaedic surgeries, thereby propelling the market for implants used in these surgeries. Orthopaedic implants have been therefore, one of the fastest growing segments in the medical device industry of the US in recent years.

In terms of medical grade plastic materials, we have seen the virtual end life cycle of Celcon acetal for medical trials by Celanese and its replacement formulation called Hostaform - a new and improved resin that we supply in extruded coloured rods.

A new exciting material also finding its way into the US market for medical trials is a material manufactured by Westlake Plastics called Propylux HS- a heat stabilised polypropylene rod manufactured in various colours offering dimensional stability, chemical resistance and biocompatibility compliance.

We have also experienced growth in our Evonik Vestakeep implantable PEEK line of rod, resin and powder for medical implants and Solvay’s Radel product has also seen tremendous growth in the medical trials market,” Bing J. Carbone, Modern Plastics

WWW.MEDICALPLASTICSNEWS.COM

27

Sticking to skin presents a major challenge to the medical device industry

Custom Packaging Solutions Focused 100% on Healthcare Nelipak provides total package, custom thermoformed solutions, value engineered to deliver ergonomic packaging fit-for-purpose reducing the cost of ownership and waste throughout the product lifecycle. Nelipak® develops award-winning packaging solutions using in-house design innovation, development, prototyping, tooling and production to ISO:13485 certified standards.

For more information, contact us: email: info@nelipak.com | phone: 401.946.2699

Visit Nelipak at Pharmapack in booth G35

SEALING MACHINES

HANDLING TRAYS

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

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

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

T

he recent Compamed exhibition (13-16 Nov) attracted a total of 780 exhibitors from 35 countries. There was even greater international participation than ever before and almost 20,000 trade visitors.

The fact that the supplier sector for the medical technology industry remains optimistic about growth is without a doubt a contributor to its success. Digitisation and miniaturisation are currently the most important drivers that are pushing progress in micro-technology as well as other areas rapidly forwards.

The demand for smart miniaturised components destined for use in medical products and efficient high-precision production processes is still rapidly increasing, according to IVAM, the Professional Association for Microtechnology.

The association, which serves an international product market, attends the fair every year.

SMART ‘PEAS’ THAT CAN BE STERILISED The Fraunhofer Institute for Electronic Nanosystems (ENAS) was also pursuing the trend towards miniaturisation. The institute travelled to the event with its ‘Sens-o-Spheres’ project, developed in conjunction with the Bioprocess Engineering Faculty at the Technical University of Dresden and industrial partners.

‘Sens-o-Spheres’ are pea-sized sensors used to monitor bio-reactor processes in the millilitre to litre range. Using the currently smallest sensors in the world, they move freely within the reaction volume and so supply continuous measurements from all areas of the reactor.

Why 2018 will be big for these product launches Compamed is a key exhibition for MPN readers. Here are some of standout launches from this annual event

The sterilisable ‘peas’ have been designed to help improve and develop processes in the pharmaceuticals and life-sciences industries.

They can be recharged overnight.

COMPAMED

SHOE INSOLES WITH PRESSURE SENSORS The Fraunhofer Institute for Silicon Technology (ISIT) is working on entirely different applications for its sensors. These measure the distribution of pressure in shoe insoles and so map gait and walking profiles. The data is sent via Bluetooth to a PC or smartphone to be processed.

“By analysing gaits and using acoustic signals while doing so, it is our aim to help people doing sports during their free time prevent injuries, rehabilitate better and improve their results,” said Lars Blohm, scientist.

A WHOLE LAB IN YOUR POCKET The Fraunhofer Institute of Applied Optics and Precision Engineering (IOF) has developed a whole pocket-sized lab that may in future be used to quickly and easily locate disease indicators in the bloodstream – and to do so at patients’ homes. The lab will do away with the need for specialist physicians, all that it requires is a disposable fluorescence chip and a smartphone.

NANO COATING REDUCES FRICTION IN SEALS Trelleborg Sealing Solutions presented its new method of coating for elastomers in Düsseldorf. The layers that this method creates are just a few hundred nanometres thin. The new coatings help simplify the installation of sealing systems while improving the quality and extending the service lives of technical medical devices.

Credit: Klaus Jopp

Dow Corning launched its strongest, most versatile liquid silicone rubbers.

Medical device manufacturers are under increased pressure to produce innovative, functional products to successfully navigate a $390 billion1 industry. Dow Medical Solutions showcased its new solutions to meet the growing needs of today’s medical device manufacturers: Dow Corning QP1-33X0 liquid silicone rubber for faster cure at lower temperatures aims to provide new options for device design, while also allowing fast injection speed at low injection pressure; Dow Corning QP1-5040 self-adhesive liquid silicone rubber enables faster cure at lower temperatures to combine hard and soft components, allowing reasonable moulding cycle times and is suitable for two-components and insert moulding.

Vancive Medical Technologies unveiled medical adhesive tapes at Medica 2017 “We were excited to use Medica 2017 as a launch pad to debut a number of new medical material innovations and contract manufacturing capabilities for medical device OEMs,” said Deepak Prakash, senior director of global marketing, Vancive Medical Technologies. “In combination with Finesse Medical, we now offer a full range of products and services, from skin-friendly tapes to finished privatelabel devices.”

The new product and service offerings highlighted at the event reflect the core competencies of both Vancive and Finesse. Finesse has a robust portfolio of silicone-based adhesive and wound care products, while Vancive is known for its innovative adhesive-coated materials. The combined organisation has expanded its capabilities in an effort to better solve product development and manufacturing challenges for medical device OEMs.

“With the aging population comes the need for more affordability, comfort and convenience in medical supplies, including silicone adhesives, an area where we continuously bring innovative solutions to the market,” said Marie Crane, medical materials market leader.

WWW.MEDICALPLASTICSNEWS.COM

29

LIQUID SILICONE RUBBER

A

s the wearable medical technology market is growing, liquid silicone rubber (LSR) material science is rapidly advancing with it. The industry shift toward wearable health devices and externally communicating medical tools has led to higher growth in both traditional rubber applications and newer ones. The unique properties of LSRs â&#x20AC;&#x201C; and other silicone materials â&#x20AC;&#x201C; have played an important role to reduce time, cost and approval processes for development of new medical devices and drugs for decades because of their safe long proven history in the market.

30

WWW.MEDICALPLASTICSNEWS.COM

LIQUID SILICONE RUBBER

Marie Crane, Dow Medical Solutions, examines how LSRs can help medical device makers reduce time and cost for new product developments such as respiratory masks

Accepted for a variety of medical uses since the early 1950s, silicone materials have two properties that are critical for driving industry innovation: biocompatibility and biodurability. Silicone elastomers are the material of choice for long-term medical implants since they can last for more than 30 years – far longer than any other material.

Because silicones are inert, they are biocompatible with the human body, with no adverse effects on human health.

Extensively studied and approved by the US. Food and Drug Administration (FDA), the proven biocompatibility of silicone materials simplifies new drug and device approvals. They also offer a range of unique properties that no other class of polymer offers. For instance, LSRs offer properties not obtainable with organic rubber materials, especially heat resistance, extreme low-temperature flexibility, biological inertness, and an intrinsic capacity for.

LSR innovations Recent advances in chemical formulations which improve injection molding processability of LSRs for the ongoing replacement of traditional materials in respiratory, external communicating and wearable monitoring devices, among others. Ideal for intricate designs and close-tolerance parts, LSRs are pumpable thermosetting silicone elastomers that can be processed by molding equipment.

In fact, LSR product development has resulted in the improved processing parameters to provide the greatest value and ease of use. The handling of LSR materials during injection molding is an inherently clean production process since the component chemicals are sealed within a closed system. Ambient air contacts the cured parts when they are removed from the mold, which limits exposure to the manufacturing environment. This also improves part quality, because contaminants can diminish physical properties of the cured rubber.

Liquid silicone rubbers are two-part, platinum-catalyzed elastomers with an operating temperature range between -40°C to 200°C, with short peaks up to 260°C. With post cure, LSRs offer a very low compression set and has improved durability over organic rubbers. These polymers are translucent, and can be pigmented to match many color requirements. New LSR formulations can cure at lower temperatures and have quick cycle times, which translates into quicker processing and greater throughput.

Next-gen LSRs from Dow Medical Solutions A longtime leader in silicone science and product

development, Dow Medical Solutions (formerly Dow Corning) recently introduced two new LSRs designed specifically for applications serving respiratory care, externally communicating devices, wearable monitoring and related components for medical device applications.

• Dow Corning QP1-5040 self-adhesive LSR is a translucent material that provides durable, primerless adhesion to resin substrates, such as co-polyester. Fast curing at temperatures that do not deflect the co-polyester components, this new LSR offers new options for device design flexibility.

• Dow Corning QP1-3340 LSR and Dow Corning QP13350 LSR are both two-part, platinum-catalyzed medical materials suitable for liquid injection molding. They enable reasonable cure times at low temperatures, which offer device designers more flexibility while allowing fast injection speeds at low injection pressures.

Due to the fact that the world’s aging population will more than double and people 65-plus will be by 2050, these new LSR products were developed with their needs in mind.

The aging population requires affordability, comfort and convenience in their medical supplies, and Dow is helping our medical device customers create cost-effective and innovative new products that meet those needs.

The future is now Wearable technology is a case in point. Wearable fitness trackers, such as FitBit and Jawbone, are largely responsible for the expansion of the flexible wearables category. LSRs are an ideal fit for wearable devices worn under frequent outdoor sun exposure because they can handle a wide range of temperatures, moisture, ultraviolet light, and ozone without degrading. Wearable devices manufactured with suitable LSRs are unlikely to cause adverse skin reactions, even when they are worn for extended periods of time.

Medical device makers dedicated to exploring new directions and creating the next generation of medical device technology are paying close attention to the evolution of LSR material science. The LSR space is rapidly expanding with new and improved materials that are replacing more traditional materials with longer-lasting, more versatile, and cost-effective solutions. LSRs bring all the wellknown advantages of silicone materials for medical device applications to bear, including safe, proven and consistent performance in a variety of applications.

WWW.MEDICALPLASTICSNEWS.COM

31

ANALYTICS

Plastic Solutions Dedicated to the Global Life Science Industry Scientific Injection Molding High Precision Plastics Fully Automated Process Clean Rooms ISO 8 - ISO 7 High Quality ISO 13485 - ISO 14001 - GMPs

Visit us at PHARMAPACK Hall 7.1 / G36

www.purelabplastics.com MPN-JANV(124mmx190mm half page).indd 1

32

11/01/2018 15:34:10

WWW.MEDICALPLASTICSNEWS.COM

DRUG DELIVERY

Land of opportunity Developments within the drug delivery market are strong. Lu Rahman looks at where the growth lies and where the some of the opportunities sit within the sector

D

rug delivery devices contribute significantly to the medical device market – from infusion catheter delivery systems to more complex connected products that have been making their way on to the market in recent years – the market is buoyant and on the up.

According to Persistence Market Research, North America leads the way in this sector, followed by Europe.

It puts this down to an increasing demand for ‘improved drug delivery systems, rising accessibility and affordability of drug delivery devices, and increasing number of chronic diseases in the region.’

Things may well change. Over the next five years, Asia looks set to become the fastest growing market for this sector ‘due to rising prevalence of various chronic diseases and ageing population in this region.’ It’s also thought that an improvement in economic conditions also looks likely to provide a boom to the drug delivery device market.

Thanks to the recent boom in mobile and digital health technologies, the connected drug delivery device market shows significant potential, providing interest to the sector. Opportunities are strong. According to Statista, the global digital health market is set to hit $2016 billion by 2020, with the mobile health market on track to reach $21 billion globally.

Over the next five years, Asia looks set to become the fastest growing market for this sector

With devices available that allow the patient to administer drugs in their own home, that also remind them to do so while recording and sending their results to a physician, it’s clear to see why such devices have gained ground.

Freeing up time for both the patient and the healthcare professional, connected drug delivery devices always had a strong chance of being a success. At the moment diabetes, cardiovascular and auto immune diseases top the list of conditions where connected drug delivery devices are stealing a march.

According to Future Market Insights one reason that connected drug delivery devices are in such demand among healthcare professionals and pharmaceutical companies is due to their effect on improved adherence to treatment protocol. Connected drug delivery devices affect drug formulation design and drug delivery decisions.

Manufacturing expertise Phillips-Medisize is an expert on the connected drug delivery device markets and the critical considerations device manufacturers need to bear in mind when producing high viscosity / high volume drug delivery devices.

With the increased use of biologics, the industry has explored ways of creating devices that can cope with these viscous substances.

In an article written for MPN last year, the company explained: “There has been a rise in popularity of wearable self-injection systems for biologics.

Instead of scheduling a doctor’s appointment for certain treatments, a wearable device allows patients to self-administer injectable medication.

By 2020, biologics are expected to make up more than half of the world’s top 100 selling drugs. To keep pace with these trends, device designers are tasked with overcoming various challenges associated with delivering these drugs.”

The future of drug delivery The drug delivery device market continually innovates with exciting initiatives, products and research pushing the sector forward.

Cilcare a leading clinical research organization specializing in ear disorders, and CBSET, a non-profit research institute specializing in the advancement of novel therapies, recently announced a collaboration with Draper, a company that focusses on the design, development and deployment of advanced engineering solutions. The company has developed a novel intracochlear drug delivery (ICDD) device for hearing loss and related indications. With the ability to maintain a precise and constant volume of the inner ear fluid and with its small size, the ICDD is being said to highlight an innovative technological solution to treat patients with congenital and degenerative hearing loss.

“The alliance between Cilcare, the world’s leading services company in ear disorders, and Draper’s expertise in biomedical solutions, will allow us to develop a new generation of treatments to cure hearing loss.

With 360 million people suffering from hearing loss in the world the stakes are high, and this collaboration provides a fast track for the development of safe, direct and effective treatments for patients.

The intracochlear drug delivery device is revolutionizing the treatment of inner ear diseases by circumventing the tissue permeation barriers that have long hampered the development of pharmacotherapies for hearing disorders,” said Célia Belline, CEO, Cilcare.

WWW.MEDICALPLASTICSNEWS.COM

33

Delivery service Joey Glassco, Elena Draganoiu and Carey Boyum, Lubrizol LifeSciences, explain how implantable drug-eluting devices provide a novel approach to patient care

I

mplantable drug-eluting devices (also referred to as implantable drug delivery systems) offer several advantages over conventional oral or parenteral drug delivery methods. For instance, they can provide localised, site specific drug delivery.1 which is especially important in applications such as cardiology and oncology, where targeted delivery can improve the effectiveness of treatment and minimise side effects or damage to healthy tissue.1,2,3 The dosage requirements often are lower than alternatives, further reducing the potential for side effects.1 Also, drug-eluting devices can improve patient compliance, one of the greatest challenges in healthcare, as about 50% of conventional medications are not used as prescribed. The treatment regimen can be simpler because it requires fewer doctorâ&#x20AC;&#x2122;s visits and dosages than traditional therapies.1

a. Intravaginal ring employing both hydrophobic and hydrophilic TPUs for the sustained co-delivery of the microbicide tenofovir and contraceptive levonorgestrel.

Photo courtesy of The Kiser Lab.

Applications of implantable drug eluting devices include, among others, diabetes management, contraception, HIV/AIDS prevention, chronic pain management, cardiology, oncology, and central nervous system (CNS) health. Along with subcutaneous implantation, various body regions can serve as implantation sites (e.g. intravaginal, intravascular, intraocular, intrathecal, and peritoneal). In the below image, a) an intravaginal ring and a b) nonbiodegradable drug-eluting device for chronic pain as examples.

In this article, developmental and commercial examples of non-biodegradable drugeluting devices will be presented, along with the versatile properties of thermoplastic polyurethanes, specifically Lubrizol LifeScienceâ&#x20AC;&#x2122;s Pathway TPU Excipients for the development of effective drug delivery systems.

34

b. Axxia Pharmaceuticalsâ&#x20AC;&#x2122; subcutaneous drug delivery system was developed to deliver an opiate continuously for 30-90 days with zero-order kinetics. Photo courtesy of Axxia Pharmaceuticals, LLC.

WWW.MEDICALPLASTICSNEWS.COM

DRUG DELIVERY DEVICES Biodegradable vs non-biodegradable There are two categories of drug-eluting devices: Biodegradable and non-biodegradable.

Biodegradable drug-eluting devices (also referred to as bioerodible) use biocompatible materials such as polyesteramide (PEA) and poly lactic-coglycolic acid (PLGA) to deliver drugs, and, once implanted, decompose over time.1,5,6 In contrast to biodegradable, non-biodegradable drug-eluting devices (also referred to as biodurable) use biocompatible materials like silicone rubber (polydimethylsiloxane or PDMS), polyethylene-vinyl acetate (EVA), and thermoplastic polyurethane (TPU) to deliver drugs.7 Non-biodegradable drug-eluting devices can be designed as matrix, reservoir, or osmotic systems to deliver drugs via diffusion or osmosis and are generally less costly than biodegradable devices. 1,15 Non-biodegradable drug-eluting devices can be refilled with medication (e.g. via injection) and the device’s effects are almost immediately reversible upon removal.1,11,8

broad range of chemical and physical properties providing variety along a number of dimensions, including drug release kinetics (short or long term); active pharmaceutical ingredient selection (hydrophobic or hydrophilic APIs); processing methods (extrusion, injection molding or solvent casting), and mechanical performance.16,9,10,11,12,13 These attributes provide developers with design flexibility.

Thermoplastic polyurethanes for nonbiodegradable drug-eluting devices Lubrizol LifeSciences partners with pharmaceutical companies from concept to commercialisation.

The company’s non-biodegradable PathwayTPU excipients can be tailored to suit a range of drug delivery applications and can be processed into a variety of shapes (e.g. rods, tubes, films and a variety of matrix-type designs) via methods such as hot-melt extrusion, injection moulding, and solvent casting. Ethylene oxide, hydrogen peroxide, E-beam radiation and gamma radiation are acceptable methods of sterilisation.

Non-biodegradable Pathway TPU excipients are designed to be versatile and customisable to a

Lubrizol’s 2013 implementation of the International Pharmaceutical Excipients Council’s Good Manufacturing Practice quality system for excipients and database generation of Drug Master Files facilitate non-biodegradable drug-eluting device development. As a result of its 2014 acquisition of Vesta and 2015 acquisition of Particle Sciences, Lubrizol provides complete drug product development including pharmaceutical-

grade polymer supply, contract research/ analytical and contract manufacturing capabilities through to commercialisation.

Thermoplastic polyurethanes have exceptional safety records with over 30 years of use in medical devices, such as catheters and pacemakers. The unique ability to customize TPU properties allows for the development of advanced drug delivery systems.

REFERENCES 1. Zaki AJ, M, Patil, SK, Baviskar, DT, Jain, DK. Implantable Drug Delivery System: A Review. International Journal of PharmTech Research.

2012;4(1):280–292. Available at: http://sphinxsai.com/2012/pharm/pharm/pt=40(280-292)jm12.pdf. Accessed 2015.

2. Drug-eluting stent. Wikipedia. Wikimedia Foundation. Available at: https://en.wikipedia.org/wiki/Drug-eluting_stent. Accessed 2015.

3. Brachytherapy. Johns Hopkins Medicine. Available at: http://www.hopkinsmedicine.org/radiation_oncology/treatments/brachytherapy.html.

Accessed 2015.

4. Medication Adherence. CDC. 2013. Available at: http://www.cdc.gov/primarycare/materials/medication/docs/medication-adherence-01ccd.pdf.

Accessed 2015.

5. Drug Delivery. Products & Technologies. DSM Biomedical. Available at: http://www.dsm.com/markets/medical/en_US/products-page/productsresorbable-materials.html. Accessed 2015.

6. Shuwisitkul, Duangratana. Biodegradable Implant With Different Drug Release Profiles. Freie Universitat, 2011. Available at: http://www.diss.fuberlin.de/diss/servlets/MCRFileNodeServlet/FUDISS_derivate_000000009580/Duangrat_thesis_online.pdf. Accessed 2015.

7. Marchant, Nancy. Drug Release and Non Degradable Polymers: Thermoplastic Polyurethanes offer greater control.

8. Mccall AA, Swan EE, Borenstein JT, Sewell WF, Kujawa SG, Mckenna MJ. Drug delivery for treatment of inner ear disease: current state of knowledge. Ear Hear. 2010;31(2):156-65.

9. Clark, Johnson et al. 2012. A hot-melt extruded intravaginal ring for the sustained delivery of the antiretroviral microbicide UC781. J Pharm Sci 101(2): 576-587.

10. Clark, Justin T., Meredith R. Clark, Namdev B. Shelke, Todd J. Johnson, Eric M. Smith, Andrew K. Andreasen, Joel S. Nebeker, Judit Fabian, David R. Friend, and Patrick F. Kiser. Engineering a Segmented Dual-Reservoir Polyurethane Intravaginal Ring for Simultaneous Prevention of HIV Transmission and Unwanted Pregnancy. PLoS ONE. Burnet Institute, Australia, 2014.

11. Clark, Meredith R., Justin T. Clark, Todd J. Johnson, Namdev B. Shelke, Joel S. Nebeker, Gustavo F. Doncel, David R. Friend, and Patrick F. Kiser.

Development and Pharmacokinetics of a 90-Day Intravaginal Ring for the Sustained Co-Delivery of the Microbicide Tenofovir and Contraceptive Levonorgestrel. USAID. 12. J.Y Cherng, T.Y. Houa, M.F.Shihb, H. Talsma, and W.E. Hennink. Polyurethane-based drug delivery systems. Int J Pharm 2013 13. Khandwekar, A.P., Patil, D. P. Hardikar, A. A. Shouche, Y.S. and Doble, M. In vivo modulation of foreign body response on polyurethane by surface entraptment technique. J. Biomed Mater. Res. 2010 14. Polyurethanes and Medical Applications. American Chemistry Council. Available at: http://polyurethane.americanchemistry.com/Introductionto-Polyurethanes/Applications/Polyurethanes-and-Medical-Applications. Accessed 2015.

WWW.MEDICALPLASTICSNEWS.COM

35

What is the link between a smartphone and a drug delivery device?

Discover how to improve nasal and ophthalmic compliance with e-AdvanciaÂŽ and e-NoveliaÂŽ

Booth D30 Paris, 7-8 February 2018

INFECTION PREVENTION

Clean g e t a w a y Juha Mattila, Steris Finn-Aqua, discusses VHP low temperature sterilisation in both material transfer and terminal sterilisation, to cover both GMP sterilisation applications

New mindset for safe and efficient material transfer Material transfer to classified aseptic manufacturing cleanroom areas (grade A or grade B) is under growing pressure to improve control and efficacy. The most common bio-decontamination technology used is VHP (vapourised hydrogen peroxide) under atmospheric and room temperature conditions. Equipment design for lowtemperature bio-decontamination of material bags, components, electronics and various manufacturing tools and devices, needs to be in alignment with its purpose.

Process and equipment design principles should be equal to a piece of sterilisation equipment, says Steris Finn-Aqua’s Juha Mattila

applying active door seal for tightness, are important. A smoke test is easy to pass, but passing the ISO 10648-2 leak test requires improved design for tightness and adds to safety from a risk management perspective.

Pharmaceutical manufacturing needs Conventional methods include manual operations to wipe material transfer bags and containers with alcohol or another disinfectant, and transfer of the wiped material through an airlock. Such procedures lack automation and consistency, in addition to being labour-intensive and time-consuming. Conventional material transfer can become a significant bottleneck that may hinder production growth of the manufacturing facility. Manual activities are likely to transfer particles to the cleanroom area.

Consistent processing requires developing production cycles for empty, partially loaded and full chamber with variable load configurations. Chemical and biological (106 CFU Bacillus Stearothermophilus) indicators are used for cycle development, and biological indicators for verification of the validated production cycles.

Application needs: • Consistent, repeatable and controlled material transfer process with proven decontamination efficacy for various loads • Peroxide concentration after cycle not to exceed 1 ppm • Minimised particulate burden • 60 minutes or less total cycle time • Optimised sterilant usage • Equipment design in accordance with GMP regulations and current GAMP guidelines and overall risk management • Acceptable footprint and serviceability • Electronic data security for enabling 21 CFR part 11 compliance Design considerations First, a VHP decontamination pass-through system for material transfer is not a material airlock that is simply equipped with a peroxide generator, although the chamber design needs to meet GMP requirements for

materials of construction in process contact areas and for cleanability (stainless steel AISI316L or equivalent with surface finish of Ra 0.6 µm or better).

Process and equipment design principles should be equal to a piece of sterilisation equipment. The main purpose of the equipment is to ensure that the biodecontamination result is achieved on all intended surfaces. Cycle pre-conditioning is required to remove as much moisture from chamber air as feasible (typically down to 6-10 % RH) to allow for sufficient hydrogen peroxide concentration to be reached. This is achieved by utilising an efficient air-drying system. Relative humidity during decontamination exposure phase must not exceed 99% RH to avoid peroxide condensation.

A strong turbulent airflow pattern with access to all surfaces from top to bottom is required for desired results. An internal chamber fan meets this design criteria well, and has proven to be most efficient in larger steam/ air mix steriliser designs for decades already.

VHP vapour must have non-restricted access to all surfaces.

A closed loop, strong airflow circulation with a HEPA filter can be utilised for capturing particles in the beginning and at the end of the cycle by implementing a particle level monitor, setting a particle level target and controlling the process performance.

Minimising equipment footprint by placing the mechanical area on top of the chamber can compromise serviceability. Therefore, side access design might be a better alternative.

Meeting 21 CFR Part 11 requirements can be achieved by using a control system design that provides a continuous audit trail and batch recording with similar performance as a GMP steam steriliser – since a VHP material transfer decontamination chamber is used exactly in the same barrier and for the same purpose.

Figure 1: Strong turbulent airflow circulation pattern in a material transfer VHP decontamination chamber

Optimal VHP amount can be ensured by using a combined humidity/VHP sensor as process controller instead of injecting predefined amounts of peroxide based on cycle development. Continuous control ensures consistency, and only the required amount of VHP is injected. Doubling VHP amount does not improve kill efficacy, but prolongs the aeration time and total cycle time, subjecting the load to more sterilant than necessary.

A closed loop design with HEPA filter and integral catalytic converter eliminates any need for connecting the equipment to HVAC system – as well as any HVAC system validation concerns (figure 1). Maintaining negative pressure during unloading, and WWW.MEDICALPLASTICSNEWS.COM

37

HIGH PERFORMANCE POLYMERS

Invibio looks at augmented biomaterial for the next generation of spinal implants.

This includes regulatory clearances for PEEK- Optima HA Enhanced in the US and CE mark approval in Europe, plus encouraging pre-clinical study results and early clinical experience

A

wealth of research and clinical experience is confirming that the use of PEEK-Optima polymerbased spinal implants confers advantages that can, potentially, enhance the efficacy of spinal implants and improve patient outcomes. Combined data from three clinical studies that directly compared PEEK-Optima with titanium devices for cervical fusion showed fusion rates between 88-100% for PEEK-Optima versus 47-93% for titanium devices.1-3 The high-performing polymer was the first implantable PEEK and introduced by Invibio Biomaterial Solutions (Invibio) in 1999. Since that time the company has pioneered further innovations and supported its partner companies with pre-clinical study results and clinical outcome data to achieve regulatory clearances and to help educate the medical community.

One such recent PEEK-based innovation was Invibio´s PEEK-Optima HA Enhanced polymer. It combines PEEK-Optima polymer with hydroxyapatite (HA) for medical applications where bone on-growth is required.

Hydroxyapatite, a well-known osteoconductive material that enhances bone apposition and a constituent of human bone, is fully integrated, not coated, into the PEEK matrix, making it available on all surfaces of a finished device, which also eliminates the time and expense of applying coatings to the manufactured implant.

Invibio´s enhanced biomaterial offers all the clinical advantages of PEEK-Optima Natural, including a modulus close to that of human bone, reduced stress shielding, and artifact-free imaging, whether by X-ray, MRI or CT scanning, allowing clear visual assessment of the fusion mass.

Pre-clinical studies demonstrate the potential benefits of PEEK-Optima HA Enhanced The performance of PEEK-Optima HA Enhanced has been studied in pre-clinical studies, and has demonstrated a greater amount of new bone formation and a higher quality of new bone bridging, within early stages of treatment, compared with the results obtained when using PEEKOptima Natural.

38

WWW.MEDICALPLASTICSNEWS.COM

HIGH PERFORMANCE POLYMERS

Invibio´s enhanced biomaterial offers all the clinical advantages of PEEK-Optima Natural Invibio commissioned an independent cervical fusion study in sheep, to compare outcomes between interbody fusion devices composed of PEEK- Optima HA Enhanced, PEEK- Optima Natural and allograft bone. Results indicate that PEEK- Optima HA Enhanced may provide several advantages4: • Greater new bone formation. PEEK- Optima HA Enhanced resulted in greater new bone formation at six weeks, compared with PEEK- Optima Natural.

• Higher quality new bone bridging. PEEK- Optima HA Enhanced provided a more favorable environment, with higher quality local bone at six and 12 weeks compared with PEEK-OPTIMA Natural.

• Enhanced mechanical performance. PEEK- Optima HA Enhanced devices outperformed allograft, with fracture of the allograft devices in 6/13 (46%) instances.

A previous study had evaluated and compared the bone ongrowth that resulted from the use of the two implantable polymers in a bone defect model in sheep, and revealed that PEEK- Optima HA Enhanced resulted in approximately 75% direct bone apposition as early as four weeks following implantation compared with PEEK- Optima Natural.5 Early clinical experience with the novel material combination A nine-patient case series was presented at the North American Spine Society (NASS) Annual Meeting in October 2016. These patients, male and female, were aged 39-76 and had varying levels of health, including pre-existing diseases or conditions, and experience of previous surgery.⁶ Patients also had various combinations of leg pain, cramping and weakness, and back pain necessitating lumbar fusion. All patients underwent a one- or two-level lumbar fusion utilising the same EVOS-HA Interbody device from Cutting Edge Spine, cage setup and pure iliac crest bone graft. The interbody fusion device used was made with PEEK- Optima HA Enhanced polymer.

Anteroposterior and lateral X-rays were taken at six and twelve weeks post-op and CT scans at six months post-op.

At six months, post-op CT scans revealed solid fusion for eight of nine patients, with solid fusion at one year for a patient with a history of heart problems and smoking.

One-year radiographs indicated solid fusion in all patients.

There were no neurologic sequelae.

Highlights of the important clinical results presented included: • More than 50% back pain reduction • Nearly all leg pain resolved • No instrumentation failures • No reoperations Timothy Bassett, MD, SouthEastern Spine Specialists, who assessed the patients’ progress and outcomes concluded: “PEEK- Optima HA Enhanced polymer shows exciting potential for use in spinal lumbar fusions. In all nine cases, the PEEK- Optima HA Enhanced Interbody Fusion Device exhibited rapid bone fusion in the interbody region and very dense bone growth around the implant as early as six weeks, typically unseen with unfilled PEEK. “As a result of PEEK- Optima HA Enhanced’s quick bond, patients are less likely to require anterior posterior reconstructions and can return to everyday function and exercise regimes sooner and with greater confidence.”

Brad Prybis, MD, Carrollton Orthopaedic Clinic, Carrollton, reported on an eight-patient case series that tested whether PEEK- Optima HA Enhanced provides better bony on-growth and fusion: “I observed pain and neurologic function and took anteroposterior, lateral and flexion extension radiographs at six months post-op.”7 Patients included males and females aged 43-66 with chronic neck, arm, hand and finger pain, numbness and weakness.

Some patients also reported loss of control, coordination and balance in the affected areas. Diagnoses included various levels and combinations of cervical radiculopathy, cervical myelopathy, myeloradiculopathy, central stenosis with spinal cord impingement, foramenal stenosis, and chronic pain.

WWW.MEDICALPLASTICSNEWS.COM

39

17â&#x20AC;&#x201C;19 April 2018 Messe Stuttgart Germany

Sharing Technology and Innovation

S FOCU 8: 1 IN 20 ealth rt H a m S and uring act f u n Ma NEW

The leading Medical Technology event in Europe

Would you like to register for FREE? Register as a visitor at http://gotomedtec.com/register

Networking

Education

Innovation

Sourcing

Start-up Academy

HIGH PERFORMANCE POLYMERS

All patients underwent a two-level Anterior Cervical Discectomy and Fusion (ACDF) with a device made with PEEK- Optima HA Enhanced. As part of this procedure, Dr. Prybis utilised a high-speed burr to maintain good bone-cage contact and some endplate bleed, when preparing the endplates for a PEEK- Optima HA Enhanced spacer.

PEEK-OPTIMA™ Natural

Radiographic Fusion Results: • Six-month, post-op follow-up showed solid fusion at 17 of the 17 levels.

Neurologic Function Results: • Improved neurologic function in all 8 patients • Residual numbness in 3 of 8 patients • Residual weakness in 1 of 8 patients Clinical Results:

PEEK-OPTIMA™ HA Enhanced

• Arm pain resolved in all 8 patients • Neck pain resolved in 5 of 8 patients • Neck pain improved in 7 of 8 patients • Neck pain unresolved in 1 patient

SOLID FUSION Solid lumbar fusion at six months with CT scan

4 week histology: More consistent and continuous degree of direct bone contact was observed.

Provided courtesy of Invibio Biomaterial Solutions Copyright ©2018 Invibio. All rights reserved

Dr. Prybis concludes: “All eight cases utilising the HA enhanced devices provided as good or better clinical and radiographic results than traditional PEEK Interbody Fusion Devices. Patients healed quicker and could return to normal activity after only two weeks. I’m convinced that HA integration does make a big difference in clinical outcomes.”

Regulatory approvals carry PEEK- Optima HA Enhanced to market Increasingly, PEEK- Optima HA Enhanced is being granted regulatory clearance and CE mark approval for entry into the medical device markets in both the US and Europe, respectively.

In 2017, the potential advantages of PEEK-OPTIMA HA Enhanced devices were highlighted when Innovasis was the first company to receive FDA 510(k) clearance for a standalone ALIF (anterior lumbar interbody fusion) system made from the polymer. This system is an intervertebral fusion device for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2S1). Used to facilitate fusion in the lumbar spine and inserted using an anterior lumbar interbody fusion (ALIF) procedure, the device meets all the surgical requirements of implant stability (anti-migration), ease of implantation, and straightforward assessment of the fusion process.

Previously, in 2015, the Atlanta, GA-based Meditech Spine received (FDA) 510(k) clearance for the next generation Talos line of cervical intervertebral fusion devices, made from PEEK- Optima HA Enhanced.

These Talos-C (HA) Cervical Intervertebral Body Fusion (IBF) devices take the form of cages intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one level from C2-T1.

The selection of the biomaterial was made after looking extensively at the PEEK- Optima HA Enhanced data, and after discussing its characteristics with many surgeons. Research helped steer the decision at Meditech Spine to add the enhanced polymer to the company’s product portfolio since it gives surgeons and their patients the best of both worlds: PEEK- Optima, a proven polymer with a modulus of elasticity close to human bone, plus HA, a material known to enhance and accelerate bone on-growth.

PEEK-OPTIMA™ Natural

PEEK-OPTIMA™ HA Enhanced

Fusion Mass: Local bone inside the PEEK-Optima HA Enhanced devices was more robust at six and 12 weeks compared with local bone inside the PEEK-Optima Natural devices at the same point.

Provided courtesy of Invibio Biomaterial Solutions ©2018 Invibio. All rights reserved

PEEK- Optima implants poised for rapid uptake For over 15 years, Invibio’s PEEK- Optima Natural polymer has delivered convincing results as a biomaterial for surgical implants.

The addition of hydroxyapatite (HA) to form Invibio’s PEEK- Optima HA Enhanced allows all the advantages of PEEK- Optima Natural to be retained by spinal implants, but with HA exposed on all surfaces of the device, for enhanced bone apposition. Pre-clinical and clinical outcome data indicate that there is the potential to accelerate the fusion and healing processes, while enhancing the quality and density of new bone on-growth. These results indicate a potential for improved patient outcomes, with all that implies for an improved quality of life.

An increased number of regulatory clearances in the US and CE mark approvals in Europe will help to ensure that innovative devices made from PEEK- Optima HA Enhanced achieve quick and effective market up-take.

REFERENCES References 1-9: Supporting information available upon request from Invibio Biomaterial Solutions, for all claims

WWW.MEDICALPLASTICSNEWS.COM

41

COATINGS

M

easures to control the spread of infection are widely practiced, but limited, so a proven complementary strategy is to integrate antimicrobial additives into plastic and polymer surfaces to make them inhospitable to bacteria.

Additives are simply and cost effectively incorporated into a variety of substrates such as polycarbonate and ABS during the manufacturing process and exert, by either chemical or mechanical means, a negative effect on any contaminating microbe causing them to die.

With Public Health England predicting that increasing antibiotic resistance could lead to 10 million deaths by 2050 worldwide, plus leading economist Lord Jim O’Neill saying it could also cost the global economy $100 trillion, reducing healthcare-associated infections (HCAIs) can only be achieved by healthcare and pharmaceutical managers being more open to innovative technologies.

Consequently, multi-modal antimicrobial silver is effective against a wide range of leading superbugs, including MRSA (a multi drug resistant variant of Staphylococcus aureus) which is responsible for a range of complications such as skin infections and more seriously blood infections.

The current HCAI regime of infection prevention and control strategies (including hand hygiene, cleaning and training procedures) has long proven to be ineffective, with 16 million extra days of hospital stay required (World Health Organisation, WHO) and 37,000 attributable deaths in Europe each year (European Centre for Disease Prevention and Control), plus annual financial losses of approximately €7 billion in Europe (WHO).

What’s more, healthcare settings themselves play a major part in spreading the infections. Along with other highly populated environments, they are a breeding ground due to shared facilities and enclosed environments, circulated air, common contact surfaces and extended mixing. Common disinfectants have limited residual effects and bacterial populations are rapidly displaying increased resistance to them.

Silver (and copper) has historically been used to preserve food and ward off infection and its antimicrobial properties have been utilised by a range of civilisations up to the present day. However, their use in medical and public health applications waned following the proliferation of the antibiotic industry after World War II - until the emergence of healthcare-associated, multi-drug resistant, disease causing bacteria led to the incorporation of inorganic antimicrobials again; but this time into plastics and other polymerised materials.

Today, BioCote silver ion antimicrobial technology makes all kinds of medical surfaces inhospitable to pathogenic microorganisms. It has no specific site of microbial attack, making evolution of resistance extremely difficult - destroying up to 99.99% of harmful bacteria, fungi (including invasive Candida species e.g., Candida auris), and even viruses like H1N1, H7N9 and the recent Aussie flu strain - through proven protein and oxidative damage, membrane disruption and DNA interference.

42

It also kills VRE and other gram positive bacteria such as Enterococcus spp, which are resistant to vancomycin and cause severe gastrointestinal conditions and are evidenced to survive for many months on hard surface.

Equally susceptible to silver in an ionic state are gram negative ESBL or Extended Spectrum Beta Lactamase bacteria like E. coli, which is particularly prevalent in the UK and best known for disease related

GOT IT COV Dr Michail Karavolos from antimicrobial technology specialist, BioCote, shares his expertise on coatings that control infections

WWW.MEDICALPLASTICSNEWS.COM

COATINGS

KEEP IT CLEAN: BioCote antimicrobial technology can be combined with hand-washing and regular cleaning to minimise cross-contamination, says Dr Michail Karavolos, BioCote

This peer reviewed study, first published in the Journal of Infection Prevention, demonstrated up to 98% reduction in bacteria between two wards, where ‘ward A’ contained BioCote treated products and ‘Ward B’ non treated products.

A similar study in a care home over a five month period, demonstrated a 95% reduction in total microorganism counts when comparing a unit (bedroom and bathroom) with and without BioCote antimicrobial treated products – this peer-reviewed study was first published in Wound Care and the British Journal of Community Nursing.

Indeed, in both studies results also indicated lower numbers of bacteria on other untreated surfaces too, due to the fact there are fewer bacteria being transferred, so using a number of antimicrobial objects in hygiene conscious settings even helps reducing the chance of pathogen spread to the wider untreated environment and causing disease.

IT VERED to the urinary tract. Likewise, carbapenem resistant Enterobacteriaceae (CRE) and carbapenemase-producing Enterobacteriaceae (CPE) like Klebsiella pneumoniae – particularly nasty causes of surgical wound infection that produce the enzyme (carbapenemase) to inactivate the antibiotic – are rendered defunct too.

Pseudomonas is a separate family (Pseudomonadaceae) but very similar to Enterobacteriaceae and Acinetobacter is another (Moraxellaceae) but also very similar to Enterobacteriaceae - and one can very reliably predict that because all of these are Gram negative bacteria, the susceptibility to silver will be very similar.

Along with Acinetobacter and Pseudomonas, CPE has been classed as the most ‘critical’ group of bacteria by the WHO, because it poses a particular threat in hospitals, nursing homes, and among patients whose care requires devices such as ventilators and blood catheters.

CPE also encompasses the likes of Escherichia, Shigella and Salmonella and having been evidenced to survive for many months on hard surfaces can cause severe, sometimes deadly, infections like septicaemia and pneumonia. Plus, hospital mortality rates are currently between 40-50%, further lending to CPEs alarming title of ‘seriously emerging infectious disease’.

With the numbers of antibiotic resistant bacteria continuing to grow, current methods to control multi-drug resistant pathogenic bacteria are increasingly limited. However, BioCote antimicrobial technology can successfully be combined with thorough hand-washing practices and regular cleaning to minimise cross-contamination and become an essential, proactive and far reaching element of healthcare infection control.

Because it does not wear out or wipe off surfaces, it can provide a continuous decontamination effect and in a ‘live’ 18-month hospital case study, antimicrobial protected polymers regularly demonstrated significant reductions in bacteria.

Going one step further, a study in collaboration with Birmingham University demonstrated visually, via epifluorescent microscopy and molecular dyes, the ability of BioCote antimicrobial technology to inhibit biofilm formation on treated plastic.

The test organism for this work was Pseudomonas aeruginosa (ubiquitous in the environment and a problematic disease-causing bacterium, particularly in the immune compromised and in healthcare settings) and via the international standard IS022196:2011 – which is the most appropriate standard for quantifying the performance of potentially antimicrobial polymers - it exhibited a highly significant antimicrobial action (99.7% reduction) against P. aeruginosa in its biofilm state.

Since antimicrobials first appeared, there is now the capacity to treat a plethora of material types and silver ions especially with their very high efficacy and non-toxic properties can quite easily be manufactured into plastics and polymers, but also paints, textiles, fabrics, ceramics, paper, etc. They’re environmentally and ecologically acceptable and lots of real data is available from surfaces prevalent in a host of environments, confirming that the efficacy of antimicrobial technology in real-life healthcare settings is comparable with that shown in laboratory validation testing.

Global awareness is such that in nearly any health facility in almost any location you will now find antimicrobial treated materials. Demands are typically highest in Asian territories, followed by North America, then South America with Europe still being the most conservative and slowest to adopt antimicrobial materials as part of everyday surfaces.

Healthcare and pharmaceutical facilities looking to adopt the technology should choose a product containing a regulated antimicrobial that is compliant with BPR/EPA regulations, plus the combinations of additive formulation within the product needs to be appropriate for the market sector. It should also be continuously quality control tested to guarantee high levels of antimicrobial performance and not just during the initial development of the treated product/surface/material.

The additive manufactured into the product is best supplied by an experienced and trusted antimicrobial solutions provider too, while the product has to be correctly labelled in line with the classifying, labelling and packaging guidelines for treated articles.

If a healthcare facility was to embark on a refurbishment program of a particular department they could make a big starting difference with key touch points, like door handles, soap dispensers, grab rails, etc, all cost effectively converted and as this type of technology significantly reduces the potential for stains and odours caused by microbes, it also keeps susceptible medical products fresher for longer and makes them much more hygienic.

Granted, antimicrobial technology doesn’t remove the need for regular cleaning, but it is arguably the best complementary strategy with integrated antimicrobial polymer protection providing a much more comprehensive and robust solution to cross contamination within hospitals, pharmacies and care homes.

With our ageing population, this duty of care approach and second line of defence strategy is increasingly important and relevant.

WWW.MEDICALPLASTICSNEWS.COM

43

SUBSCRIBE TODAY

FOR THE EUROPEAN ISSUE | FREE ACROSS EUROPE Medial Plastic News is the essential information source for anyone involved in design, manufacture and supply of medical plastics devices.

Through opinion, analysis and thought leadership, we engage and connect our community with information on materials, medical advancement and manufacturing processes.

Our expert editorial team will keep you at the forefront of an industry thatâ&#x20AC;&#x2122;s crucial to advancing healthcare internationally.

To receive your free weekly newsletter and bi-monthly print magazine visit our website. www.medicalplasticsnews.com @MPN_Magazine

44

WWW.MEDICALPLASTICSNEWS.COM

PACKAGING

L

W

e don’t need to be told how important it is to be sustainable.

We are aware of the need to reuse and recycle and there can’t be many industries that haven’t explored how they can contribute to the circular economy.

Being sustainable For some time we fell out of love with squeezing the is a given. But life out of products, using how does it fit into something to its highest value the healthcare and re-using where possible. packaging In recent years however, society and business has industry? Lu increasingly started to look Rahman has a at the entire life cycle of a look at some of product and its impact on the the issues the environment from sourcing, to manufacture, to end use.

sector faces in a bid to join the circular economy

Medical devices however, and the packaging they are ensconced in, can often fall short of our desire to re-use and recycle.

Single use devices are exactly that - single use – and as such the amount of packaging they create can be higher than many other sectors.

With issues of contamination to consider, many medical devices don’t have the option of being recycled, hence higher healthcare waste.

The packaging market is big business.

According to a Mordor Intelligence report on global medical packaging, the sector was worth $21.64 billion in 2016. This is set to rise to $30.5 billion by 2021. It’s a considerable market and its size reflects the extensive process that a medical device goes through on its journey to the patient – manufacture, sterilisation, transportation and use, for example. Given the cost and technology contained in the majority of medical devices, the need for secure, safe, sterile packaging that can withstand physical and atmospheric challenges, is paramount.

i a

n

e ’t s g o r o

un

d ag

According to Future Market Insights: “The advent of thermoformable materials enabled usage of new packaging solutions such as, thermoformed trays and blister packaging.

Thereafter, a growing demand for good lidding materials compelled the manufacturers of medical device packaging solutions to come up with new packaging solutions with improved film laminations, which was made possible by the introduction of thermoplastic polymers.”

One could argue that for certain industries – healthcare packaging being one of them – style and function can overtake sustainability.

And why wouldn’t this happen? Where medical device manufacturers and pharmaceutical companies are concerned, the priority has to be patient safety and regulation compliance. If sustainability can follow, it’s a win-win situation.

Despite the complexity of the market, it doesn’t mean the industry is oblivious to the need to be sustainable. Indeed, the adoption of sustainable features in healthcare packaging may make one firm stand out from another.

For instance, says Future Market Insights: “Auto identification is one of the technologies that is used to help the machines identify objects or persons. This includes a number of individual technologies such as barcodes, biometrics, and Radio-Frequency Identification (RFID). The advent of smart and intelligent packaging systems has enabled medical device packaging manufacturers to optimize their efficiency, thereby facilitating growth of the medical device packaging market.”

Last year HPRC Europe and Aarhus University Hospital hosted a workshop focused on enabling circular economy solutions related to healthcare plastics and packaging. With stakeholders representing plastic suppliers,

WWW.MEDICALPLASTICSNEWS.COM

medical device manufacturers, hospitals, and recyclers, the event tackled challenges in recycling healthcare plastics within the European regulatory landscape and posed possible solutions based on value chain collaboration.

“There is an increasing expectation on businesses to take responsibility for afterlife of their products,” says Klaus Stadler, director of HPRC Europe. “We see tremendous opportunity within the healthcare industry to develop solutions that are consistent with these expectations and that seek to optimize plastic resource use and re-use. This workshop was a great first step in opening up value chain dialogue and knowledge sharing on this topic.”

Participants included representatives from Baxter, BD, B. Braun, Borealis, Fresenius, LyondellBasell, Johnson & Johnson, Stena, and Suez, along with local hospitals.

“We all have a responsibility to better manage waste,” said Susanne Backer, circular economy project manager at Aarhus University Hospital and current HPRC advisory board member.

“For the past year, Aarhus University Hospital has been mapping its plastic waste streams to identify opportunities for recycling. By participating in HPRC, we now have a platform to engage and collaborate with other value chain players to achieve better results and impact.”

Nelipak Healthcare Packaging recently joined the HPRC. “Nelipak is committed to sustainable practices and works with our customers to provide a systematic approach to the packaging process which results in efficient design, material use, pack configuration, handling, shipping and end user costs,” said Seán Egan, director of global marketing, Nelipak Healthcare Packaging.

45

machined. melted. extruded. welded. compounded. blow molded. injection molded.

Weâ&#x20AC;&#x2122;ve got it covered. casted. fabricated. foamed. thermoformed. rotation molded. vacuum formed. cooled. heated. sealed.

Innovation. Technology. Sustainability.

From equipment and trends to the people advancing thermoset. plastics manufacturing, NPE2018: The Plastics Show has it covered. Be there to discover new ways to packaged. maximize efficiency, advance your operations and achieve success. transported. consumed.

REGISTER TODAY AT NPE.ORG recycled.

MAY 7â&#x20AC;&#x201C;11, 2018 | ORL ANDO, FL , USA

PACKAGING

PART OF THE PROCESS

Paul Treible, Nelipak Healthcare Packaging explains how more accurate packaging specifications and innovative product design can aid the validation process

V

alidation protocols across the medical device industry have become increasingly sophisticated in recent years to help ensure quality and avoid delays to market. But one aspect of the process that has been slower to evolve – which can ultimately create challenges for launching a product – is the packaging specifications that are evaluated. Generic specifications are still commonly used for healthcare packaging, but listing critical-to-quality requirements that are not linked to the functionally or intended use of a packaging product can lead to ineffective criteria being used to gauge the efficacy of medical device packaging. This can result in considerable delays to market and ultimately cost the OEM unnecessary time, money and resources to rectify.

For example, in some cases generic specs may indicate that length is critical and that a tray needs to meet a maximum and minimum length while the tray is non-sterile (or even when it gets sterilised). However, this shouldn’t be the case in scenarios where the tray is not actually the sterile barrier and the product goes inside of a sterile pouch. In this situation, there should only be a maximum length specified. Accommodating these generic specifications can cause major product launch delays for the OEM if the packaging thermoformer has to go back and revise a drawing to adjust the length and tolerance in order to meet criteria that is not even applicable.

The validation process and path to market can go much more smoothly if OEMs and their medical device packaging provider collaborate earlier in the process to develop custom specifications that take in to account the Design Failure Mode Effects Analysis (DFMEA). This helps to ensure that all required specs are critical-to-quality and are accurately related to the product’s intended use and function. It can also speed time-tomarket by eliminating the complexities of making the packaging meet non-relevant and sometimes unrealistic generic specs in order to successfully pass the validation process.

Taking the time up front for OEMs and their packaging manufacturing partner to review DFMEAs and talk through which specifications are actually critical.

To do this successfully, it’s extremely beneficial for OEMs to choose a packaging thermoformer that understands DFMEAs and brings a thorough understanding of industry trends, enduser needs and challenges to every project. It’s no longer enough to just have comprehensive manufacturing capabilities; a packaging partner must be able to deliver insight and innovation early in the design phase in order to create custom specifications by which to best validate a product.

The benefits of design innovation Product innovation in the design phase is beneficial for far more than just making sure packaging specs are accurate and meaningful for the particular scenario; it also helps create a product that can better serve its purpose and even minimise risk factors when used in critical healthcare environments.

Thermoformers need to understand how packaging influences the customers’ operations and supply chain. In addition to reducing the overall amount of plastic used and footprint of the product, well-designed products have the ability to reduce labour and handling costs such as transportation, sterilisation and storage through the supply chain.

Taking the manufacturing process in to account during the design phase is another factor that makes the path to market smoother in the long run. Prediction tools allow designers and tool makers to understand how a part will behave during manufacturing and to amend accordingly to maximise production runs. The packaging design team should also be mindful of what automation settings the OEM uses in its manufacturing processes to ensure products are properly engineered for the process.

Ultimately, communication and collaboration between OEMs and packaging thermoformers early on in the product design phase will result in more innovative, fit-for-purpose products that can be properly validated based on relevant, custom specifications – resulting in products getting to market on time and without unnecessary roadblocks.

WWW.MEDICALPLASTICSNEWS.COM

47

ROBOTS & AUTOMATION

Intelligent thinking Jeremy Russell, OR Productivity, surgical robot expert, pinpoints where the challenges and opportunities are in the surgical robot market

I

t’s been just over 36 years since the first laparoscopic removal of an appendix was performed in Germany, which caused such controversy that the then-president of the German Surgical Society suggested that the surgeon be suspended from medical practice.

Today, close to 10 million laparoscopic procedures are projected to be undertaken this year alone, and an estimated 750,000 of them will be conducted by the Da Vinci surgical robot.

So, as surgery becomes increasingly robotic, it’s worth pausing to review the benefits and trends of robotic surgeries.

Firstly, robotic surgery is not really ‘robotic’ but is a ‘master-slave’ relationship with a human surgeon.

Most of what we call ‘robotic’ surgery essentially involves a mechanical medical device being controlledby a surgeon, which allows them to conduct a specific task more efficiently and accurately.

Secondly, if robots can improve visualisation and dexterity, and deliver better outcomes and shorter procedure times, then the logical path is to apply these robotic technologies to more procedures.

The only limitation is the cost of that move.

Surgical robotics: The current state of play Surgical robots are typically very expensive. Most often they comprise of a unit placed over the patient with a separate control console for the surgeon.

The Da Vinci Surgical System is the most notable example. It uses a magnified 3D high-definition vision system with tiny flexible instruments far more manoeuvrable than the human hand.

However, if the drive to robotisation of laparoscopic surgery is to proceed, then the cost of delivering the benefits has to be very much reduced. Companies such as ORP provide the FreeHand robotic arm – a system to hold and control a laparoscope using surgeon head movements and a foot pedal.

Moreover, with the global shortage of healthcare staff forecast to grow over the next few years, the ability of surgeons to operate more independently with a robotic, rather than a human assistant, will deliver both cost savings and productivity benefits.

Cost It is likely that the move to more widespread adoption will be more rigorously debated and analysed than the initial moves into robotic surgery.

However, with staffing of healthcare systems becoming an increasingly important global issue, the ability to deliver more controlled and accurate surgery using fewer members of staff will undoubtedly be attractive.

And, if robotic systems are shown to increase efficiency and safety whilst bringing down costs, it will become increasingly difficult for institutions to drag their feet in adopting them.

Convincing healthcare systems to invest in these systems in order to deliver substantial savings elsewhere will be a challenge, but no more so than other innovations that are developed.

The greatest challenge to the implementation of such devices, is the cost. However, one can argue that investing in these technologies isn’t just a sensible financial decision, it’s also an urgent moral decision that could help save the NHS as we know it.

The economics Regardless of institutional hesitations, market projections appear to predict that robot surgery is winning the economic argument. The Surgical Robotics Market was evaluated at $3bn in 2014, and is expected to double to $6bn by 2020, according to Allied Market Research.

And due to a growing demand for minimally invasive procedures, the global market for laparoscopic devices alone is projected to reach $12.3bn by 2024.

At less than £150 per procedure, the cost of the system is a fraction of robots like the Da Vinci system, which typically costs £3,000-plus per procedure.

With the advent of new suppliers of robotic tools from the likes of the United States Medical Innovations, Flexdex Surgical, and FreeHand already providing low-cost solutions, the growing surgical revolution is already upon us.

How this new revolution will transpire is unclear, but the new robotic options will challenge the institutional mindset that robotic surgery is specialised and expensive.

FREE WORLD: FreeHand is one of the companies already supplying low-cost solutions for surgical use

Lower costs will enable direct economic benefits to be much more easily established and allow healthcare systems around the world to determine how best to apply these new technologies.

48

WWW.MEDICALPLASTICSNEWS.COM

ROBOTS & AUTOMATION

T

he rise of robotics and automation within the manufacturing sector has been impressive. So too are the opportunities this technology offers, both in terms of its financial contribution and the benefits these products bring to businesses in terms of long term cost savings and improved efficiencies.

According to Loup Ventures, the market is set to reach $33.8 billion by 2025. In the manufacturing environment robots and automated systems have a range of uses including polishing and deburring implants or injection moulded components. They also have a significant place in the medical packaging sector and can help improve efficiency and cost throughout the process.

Robots in action Staubli, a well-known name in this market, says that medical device manufacturers and suppliers of plastic injection moulding machines are increasingly relying on its robots. Additional applications include polishing orthopaedic implants and automating the quality process.

Boehringer Ingelheim produces pocket-sized inhalers under the product name Respima Soft Inhaler. They obviously require stringent safety and quality standards which means extensive testing during production, including processintegrated testing as well as strain, compression and high-pressure testing under cleanroom conditions. These tests are conducted in parallel with ongoing production to provide information about the product quality.

To test the inhaler dosing sprays, Boehringer Ingelheim ordered a test cell with a Stäubli six-axis robot. Criteria for the design of the system were compliance with the cleanroom classification and a space-saving layout.

Testing of the functional elements of the inhaler spray is carried out on the system seven days a week in shift operation. A centrally placed cleanroom version of a six-axis TX60L robot from Stäubli handles the components to be tested. The system tests the parts to destruction.

The company says that customer benefits include a significant increase in productivity, extremely short cycle times, compliance with the highest quality standards, as well as being easy to service and maintain, with low energy consumption.

Universal Robots also reports positive installations. Trelleborg Sealing Solutions needed to optimise production with orders ranging anywhere from a single unit to several million. Customers were demanding lower prices, higher quality and faster delivery.

Following a major modernisation of the machinery at its Danish production site the company faced a space problem - its new CNC machines were taking up far more cubic metres than the old-fashioned turning

machines. This meant that optimising processes by means of robotic arms was difficult.

“We researched the market for suitable robots for years, but every single one we looked at required safety shielding. It made them unattractive for us, since we are unable to extend the actual production area at our factory in Denmark,’ said production manager, Trelleborg Sealing Solutions in Denmark, Jesper Riis.

The robot also needed to be easily deployed and programmed to accommodate a production with orders ranging from a single unit to series of several million.

Trelleborg Sealing Solutions finally came upon the robot arms from Universal Robots. “Now we can produce at a much more competitive price than before. With flexible, lightweight robots from Universal Robots we have a useful tool to optimise everywhere in our production,” said Riis.

The UR robots also allow one operator to keep a cell with eight CNC machines running at a time– previously the maximum was three. As a result, Trelleborg has saved 1.5 employee per cell per shift.

If there was any doubt about the growth of robotic solutions, look at the Wittmann Group.

The company has reported that 2017 has been a highly successful year for its robot business. In fact, it says, the result could not have been more positive as its robot segment reached a new record in sales. A total of 5,000 robots were shipped from the company’s four robot plants in Europe, China and the USA. Automation solutions were also on the up, most of them tailored to the customer’s requirements.

We are hearing increasingly about cobots – humans and robots working collaboratively in the manufacturing space. Whereas robots have historically been locked behind cages on the manufacturing floor, humans and machines are now working side by side thanks to lighter, more mobile systems that use sophisticated sensor technology to ensure human safety. These systems offer both usefulness and versatility – they can be moved around a facility to assist with a range of tasks.

It’s an exciting time for the robots market – not just for suppliers but also for medical device manufacturers who are set to benefit from the ongoing developing technology that will improve production processes.

System addict The benefits that robotic systems can bring to medical device manufacturing are well-known. Lu Rahman looks at some successful installations and some of the future developments ahead

WWW.MEDICALPLASTICSNEWS.COM

49

Five stats about the medical device sector The global medical plastic market size is expected to reach $ 33.6 billion by 2025, says Grand View Research

1

According to Allied The global market Market Research for wearable global the catheters medical devices was valued at $4.8 market was valued billion in 2015. This market at $8,905 million in 2015, and is expected to reach is expected to increase to nearly $19.5 billion in 2021, $15,830 million by 2022. according to Cision

2

3

The global smart medical devices market is expected to reach $24.46 billion by 2025, according to a report by Grand View Research,

4

The global medical coatings market is projected to reach $15.15 billion by 2021. This high growth is in part due to healthcare acquired infections globally.

5

02:2018 F

Supplying the NHS getting costlier, survey finds

our out of every five medtech companies have seen their costs of serving the NHS increase over the past year, an ABHI survey can reveal.

A business survey, compiled by the UK’s medtech trade association, found that the single greatest challenge for companies was selling to the NHS, with 85% experiencing increases due to costly measures such as the eProcurement strategy, credentialing, and added regulatory fees.

The industry, that has grown at a rate of 9% in recent years, is now worth over £17bn to the U.K. economy.

However, uncertainty around Brexit has meant over one third of companies have delayed investment decisions. 70% of companies expect

What a winner: Diseasedetecting device scoops award

A

their exports to Europe to increase in 2018. This is higher than any other market and highlights the need to manage Brexit correctly, to ensure the trading opportunity that Europe represents is not lost.

device which allows people to detect diseases using a smartphone has won a £30,000 innovation competition.

Developed by Dr Arslan Khalid of Scottish start-up Mobi Dx, iVisco allows for the early detection of diseases by profiling a single drop of blood.

Commenting on the findings, ABHI CEO Peter Ellingworth said: “The messages from our members are clear. We must get Brexit right to ensure patients have prompt access to products. The current procurement environment is hostile to companies when it focusses purely on the lowest cost. Failure to purchase on the basis of quality and value to the system is not beneficial to the patient, nor does it provide efficiency. Quality is critical to providing safe and effective care, whilst delivering long-term savings to the NHS.”

Intended to be used in developing nations, iVisco measures blood clotting time by using acoustic fields.

Khalid was inspired by the rural population of Pakistan, where he said everyone has a smartphone but no access to clinics. iVisco won the inaugural Morgan Innovation & Technology (MIAT) Prize which took place at Santander’s London headquarters.

Speaking at the awards ceremony, Khalid said: “Winning this prize means everything to me. I’ve been working on iVisco for four years and finally amazing things are happening. Morgan’s R&D expertise will be crucial to getting it to market. Their input is worth more than money to me.”

Check out...

T

This LBR Med lightweight robot has a range of capabilities including: ultrasound scanning, needle biopsy, suturing, etc.

The global event for medical technology was the ideal platform for Kuka to showcase a new collaborative robotic technology developed specifically for healthcare.

Michael Otto, vice president of the Healthcare & Advanced Robotics Division at KUKA Roboter said: “The robotic assistance systems developed in cooperation with our medical product manufacturers make

he world’s first robotic component certified for integration into a medical product which was demonstrated at the 2017 RSNA show, Chicago.

WWW.MEDICALPLASTICSNEWS.COM

us the leading supplier of technology for customers in the medical technology sector. With our application developments, we aim to make a major contribution to patient safety and also meet the high requirements of medical technology.”

5 THINGS TO CONSIDER 5 THINGS TO CONSIDER WHEN MANUFACTURING CONNECTED WHEN MANUFACTURING DRUG DELIVERY DEVICESCONNECTED DRUG DELIVERY DEVICES The estimated number of connected drug delivery devices continues to increase andestimated the impactnumber of this trend could bedrug significant, The of connected deliveryexplains devicesPhillips-Medisize continues to increase

5 THINGS TO C

and the impact of this trend could be significant, explains Phillips-Medisize

WHEN MANUFACTU DRUG DELIVERY DE

The estimated number of connected drug deli and the impact of this trend could be significa

While digital connectivity or connected health can improve the coordination and delivery of patient care, original equipment managers needimprove to keepthe these five thingsand in mind when While digital connectivity or connected health can coordination delivery creating drug delivery devices: of patientconnected care, original equipment managers need to keep these five things in mind when

creating connected drug delivery devices: 1 Development strategy and design consideration Situation analysis and and patient compliance 12 Development strategy design consideration While digital connectivity or connected health c 3 Connectivity ecosystem of patient care, original equipment managers ne 2 Situation analysis and patient compliance creating connected drug delivery devices: Wireless subsystem 34 Connectivity ecosystem Security subsystem of device and information 45 Wireless

1 Development strategy and d

5 Security of device and information 2 Situation analysis and patien As the Internet of Things continues to become an integral part of people’s lives, the opportunity 3 Connectivity ecosystem to use it within drug delivery device applications remains promising.

The manufacturers As the Internet of Things continues to become an integral part of people’s lives, opportunity 4 the Wireless subsystem and device designers must identify, investigate and overcome these challenges so that the 5 Security of device and inform to use it within drug delivery device applications remains promising. The manufacturers implementation of wireless and other related smart technologies canchallenges be achieved.

When done and device designers must identify, investigate and overcome these so that the As the Internet of Things continues to become a successfully, connected systems enable the patient and caregivers have a 360°When view of implementation of wireless and other related smart technologies cantobe achieved. done to use it within drug delivery device applications both the patient and thesystems diseaseenable – not only manage but to improve successfully, connected theto patient andadherence, caregiversand to have a 360° results view ofby device designers must identify, investigate understanding of the regimen. both the patientthe andeffect the disease – not only to manage adherence, implementation but to improveofresults wirelessby and other related sm understanding the effect of the regimen.

www.phillipsmedisize.com 7 & 8 February 2018 www.phillipsmedisize.com Visit us at stand a46

Anzeige_297x210mm-crj.indd 1

successfully, connected systems enable the pat both the patient and the disease – not only to m understanding the effect of the regimen.

www.phillipsmedisize.com 10/10/2017 11:49:04 AM